UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________________________

FORM 10-K

_________________________________

(Mark One)


x			ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, ~~2024~~2025


o			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission file number 001-40502

_________________________________

Lyell Immunopharma, Inc.

_________________________________

(Exact name of registrant as specified in its charter)


Delaware			83-1300510
(State or other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification No.)
201 Haskins Way
South San Francisco, California			94080
(Address of Principal Executive Offices)			(Zip Code)

(650) 695-0677

Registrant’s telephone number, including area code

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

LYEL

The Nasdaq Global Select Market

Securities registered pursuant to section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes o No x

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No x

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports); and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	o	Accelerated filer	o
Non-accelerated filer	x	Smaller reporting company	x
		Emerging growth company	o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. o

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. o

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No x

The aggregate market value of the common stock held by non-affiliates of the registrant on June 2830, ~~2024~~2025, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $~~306~~129 million based on the closing price reported for such date on The Nasdaq Global Select Market.

The registrant had ~~295~~23,~~228~~307,~~868~~143 shares of common stock outstanding as of March 69, ~~2025~~2026.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant’s Proxy Statement for the ~~2025~~2026 Annual Meeting of Stockholders are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein. Such proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrant’s fiscal year ended December 31, ~~2024~~2025.

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Lyell Immunopharma, Inc.

~~2024~~2025 Annual Report on Form 10-K

Table of Contents

		Page
Special Note Regarding Forward-Looking Statements		1
Summary of Risk Factors		2
	PART I
Item 1.	Business	5
Item 1A.	Risk Factors	3135
Item 1B.	Unresolved Staff Comments	7378
Item 1C.	Cybersecurity	7378
Item 2.	Properties	7479
Item 3.	Legal Proceedings	7579
Item 4.	Mine Safety Disclosures	7580
	PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	7681
Item 6.	[Reserved]	7781
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	7882
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	8993
Item 8.	Financial Statements and Supplementary Data	9194
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	~~124~~127
Item 9A.	Controls and Procedures	~~124~~127
Item 9B.	Other Information	~~125~~128
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	~~125~~128
	PART III
Item 10.	Directors, Executive Officers and Corporate Governance	~~126~~129
Item 11.	Executive Compensation	~~126~~129
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	~~126~~129
Item 13.	Certain Relationships and Related Transactions, and Director Independence	~~126~~129
Item 14.	Principal Accountant Fees and Services	~~126~~129
	PART IV
Item 15.	Exhibits and Financial Statement Schedules	~~127~~130
Item 16.	Form 10-K Summary	~~130~~133
SIGNATURES		~~131~~134

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements. All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future results of operations and financial position, business strategy, product candidates, planned nonclinical studies and clinical trials, results of nonclinical studies and clinical trials, research and development costs, planned regulatory submissions, regulatory approvals and the timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential” or “continue,” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Annual Report on Form 10-K include, but are not limited to, statements about:

•the sufficiency of our existing cash to fund our future operating expenses and capital expenditure requirements;

•the accuracy and timing of our estimates regarding expenses, revenue opportunities, capital requirements and needs for additional financing;

•the scope, progress, results and costs of developing ~~IMPT~~rondecabtagene autoleucel (ronde-~~314~~cel, also known as LYL314), LYL273 (formerly known as GCC19CART) or any other product candidates we may develop or acquire, including both nonclinical studies and clinical trials;

•the timing and costs involved in obtaining and maintaining regulatory approvals of ~~IMPT~~ronde-~~314~~cel, LYL273 or any other product candidates we may develop or acquire, and the timing or likelihood of regulatory filings and approvals, including any expectations or plans regarding seeking or maintaining special designations, such as Regenerative Medicine Advanced Therapy designation, Orphan Drug designation or Fast Track designation, for our product candidates for various diseases;

•our plans relating to the commercialization of ~~IMPT~~ronde-~~314~~cel, LYL273 or any other product candidates we may develop or acquire, if approved, including the geographic areas of focus, and our ability to commercially differentiate such product candidates and build a sales force;

•the size of the market opportunities for ~~IMPT~~ronde-~~314~~cel, LYL273 or any other product candidates we may develop or acquire in each of the diseases we may target;

•our reliance on third parties to conduct research activities for ~~IMPT~~ronde-~~314~~cel, LYL273 or any other product candidates we may develop or acquire;

•the characteristics, safety, efficacy and therapeutic effects of ~~IMPT~~ronde-~~314~~cel, LYL273 or any other product candidates we may develop or acquire;

•the advancement of our ~~technology~~technologies ~~platforms~~ and the effectiveness and expected benefits of any of our technologies and manufacturing processes;

•our estimates of the number of patients in the United States and worldwide who suffer from the diseases we target and the number of patients that may enroll in our clinical trials;

•the progress and focus of the current and planned clinical trials of our product candidates, and the reporting of data from those trials, including the timing thereof;

•the ability of our clinical trials to sufficiently demonstrate the safety and efficacy of ~~IMPT~~ronde-~~314~~cel, LYL273 or any other product candidates we may develop or acquire, and other clinical trial results;

•the success of competing therapies that are, or may become, available;

•developments relating to our competitors and our industry, including any existing or future competing product candidates or therapies;

•our plans relating to the further development and manufacturing of ~~IMPT~~ronde-~~314~~cel, LYL273 or any other product candidates we may develop or acquire, including lines of therapy or additional indications that we may pursue;

•existing regulations and regulatory developments in the United States and other jurisdictions;

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•our potential and ability to successfully manufacture and supply or our ability to contract with third parties to manufacture and supply ~~IMPT~~ronde-~~314~~cel, LYL273 or any other product candidates we may develop or acquire for clinical trials and for commercial use, if approved;

•the rate and degree of market acceptance, as well as the pricing and reimbursement, of ~~IMPT~~ronde-~~314~~cel, LYL273 or any other product candidates we may develop or acquire, if approved;

•our continued reliance on third parties to assist us in conducting additional clinical trials of ~~IMPT~~ronde-~~314~~cel, LYL273 or any other product candidates we may develop or acquire;

•the scope of protection we are able to establish and maintain for intellectual property rights, including covering ~~IMPT~~ronde-~~314~~cel, LYL273 and other product candidates and ~~technology~~technologies ~~platforms~~ we may develop or acquire;

•our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel;

•our expectations regarding the impact of inflation, macroeconomic conditions and geopolitical conflicts on our business and operations, including on our manufacturing suppliers, collaborators, contract research organizations (CROs) and employees;

•our ability to realize the anticipated benefits of and potential value created by our acquisition of ImmPACT Bio USA Inc. (ImmPACT), our acquisition of rights to LYL273 from Innovative Cellular Therapeutics or any other acquisition or strategic transaction and our success in commercializing any product candidates we acquire in connection therewith~~, including IMPT-314~~;

•~~the~~our ~~inherent~~expectation ~~risks,~~that ~~costs~~our ~~and~~LyFE ~~uncertainties~~Manufacturing ~~associated~~CenterTM ~~with~~and, ~~integrating~~if ~~the~~applicable, ~~businesses~~contract indrug ~~the~~manufacturing ~~merger~~organizations ~~with~~engaged ~~ImmPACT~~by ~~successfully~~us, ~~and~~will ~~the~~provide ~~amount~~sufficient ofdrug ~~any~~supply ~~costs,~~for ~~fees,~~our ~~expenses,~~ongoing ~~impairments~~ and ~~charges~~planned ~~relating~~clinical totrials ~~the~~and ~~acquisition~~through ofpotential ~~ImmPACT~~commercial launch; and

•the potential impact of the reported Nasdaq notification on the listing of our common stock or the non‑compliance with the Nasdaq listing rules and our intent to monitor the bid price of our common stock and implement available options, including a reverse stock split, if necessary, in order to regain compliance;

•our ability to successfully appeal a delisting determination, if a delisting notice is received, and the impact of any such delisting; and

•our anticipated use of our existing cash, cash equivalents and marketable securities.

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Annual Report on Form 10-K and are subject to a number of risks, uncertainties and assumptions described under “Risk Factors” in Part I, Item 1A, and elsewhere in this Annual Report on Form 10-K. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in these forward-looking statements. Except as required by applicable law, we undertake no obligation to update or supplement any forward-looking statements publicly, or to update or supplement the reasons that actual results could differ materially from those projected in these forward-looking statements, even if new information becomes available in the future.

In addition, statements indicating that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Annual Report on Form 10-K, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.

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SUMMARY OF RISK FACTORS

Below is a summary of material factors that make an investment in our securities speculative or risky. Importantly, this summary does not address all of the risks and uncertainties that we face. Additional discussion of the risks and uncertainties summarized in this risk factor summary, as well as other risks and uncertainties that we face, can be found under “Risk Factors” in Part I, Item 1A of this Annual Report on Form 10-K. This summary is qualified in its entirety by that more complete discussion of such risks and uncertainties. You should carefully consider the risks and uncertainties described under “Risk Factors” in Part I, Item 1A of this Annual Report on Form 10-K as part of your evaluation of an investment in our common stock.

•We are a ~~clinical~~late-stage ~~biopharmaceutical~~clinical cell therapy company that has incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing net losses for the foreseeable future.

•We operate in a rapidly evolving field and have a limited operating history, which may make it difficult to evaluate the success of our business to date and to assess our future viability.

•We currently have no products approved for sale and have never generated revenue from product sales. We may never generate revenue from product sales or achieve profitability.

•We will require substantial additional capital to achieve our goals, and a failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.

•We currently have no products approved for sale and have never generated revenue from product sales. We may never generate revenue from product sales or achieve profitability.

•We operate in a rapidly evolving field and have a limited operating history, which may make it difficult to evaluate the success of our business to date and to assess our future viability.

•Our milestone, royalty and success payment obligations may result in dilution to our stockholders or may reduce the availability of our cash resources to satisfy the payment obligations, which could cause our operating results and financial condition to fluctuate significantly from quarter to quarter and year to year and may reduce the usefulness of our GAAP consolidated financial statements.

•~~Our~~If ~~product~~we ~~candidates and technology platforms~~ are ~~based~~unable onto ~~novel~~successfully ~~technologies~~develop, ~~that~~manufacture ~~are unproven~~ and ~~may~~commercialize ~~not~~product ~~result~~candidates ~~in approvable~~ or ~~marketable~~experience ~~products,~~significant ~~which~~delays ~~expose~~in usdoing ~~to unforeseen risks and make it difficult for us to predict the time and cost of product development and potential for regulatory approval~~so, ~~and~~our webusiness may ~~not~~ be ~~successful in our efforts to use and expand our technology platforms to develop any product candidate~~harmed.

•WeOur ~~currently~~product ~~have~~candidates noand ~~marketing,~~technologies ~~sales~~are based on novel technologies that are unproven and may not result in approvable or ~~distribution~~marketable ~~infrastructure~~products, which expose us to unforeseen risks and wemake ~~intend~~it difficult for us to ~~either~~predict ~~establish~~the atime ~~sales~~and cost of product development and ~~marketing~~potential ~~infrastructure~~for orregulatory ~~outsource~~approval, ~~this~~and ~~function~~we tomay anot ~~third~~be ~~party.~~successful ~~Either~~in ofour ~~these~~efforts ~~commercialization~~to ~~strategies~~use ~~carries~~and ~~substantial~~expand ~~risks~~our technologies to usdevelop any product candidate.

•WeThe ~~currently~~results ~~manufacture~~of ~~drug~~research, ~~products~~nonclinical ~~for~~studies ~~our~~or earlier clinical trials ~~ourselves.~~are ~~Delays~~not innecessarily ~~further~~predictive ~~qualifying~~of orfuture inresults. ~~receiving~~If ~~regulatory~~clinical ~~approvals~~trials ~~for~~of ~~any~~our ~~manufacturing~~product ~~facility~~candidates orfail ~~product~~to ~~candidates~~produce, or incontinue ~~expanding~~to ~~our~~produce, ~~manufacturing~~positive ~~capacity~~results or ~~finding~~demonstrate ~~suitable~~satisfactory ~~third-party~~safety ~~manufacturing~~and ~~partners~~efficacy, ~~could~~at ~~delay~~the ~~our~~appropriate ~~development~~dose ~~plans~~level ~~and~~or ~~thereby~~at ~~limit~~all, ~~our~~we ~~ability~~may incur additional costs or experience delays in completing, or ultimately be unable to ~~generate~~complete, the development and commercialization of our product ~~revenues~~candidates.

•~~The~~Clinical ~~manufacturing~~development ofinvolves ~~cellular therapies is very complex. We are subject to~~ a ~~multitude~~lengthy ofand ~~manufacturing~~expensive ~~risks,~~process ~~including risks associated~~ with ~~supply~~an ~~chain~~uncertain ~~complexity related to patient materials, any of which could substantially increase our costs, delay our programs or limit supply of our product candidates~~outcome.

•WeInterim, ~~may~~topline ~~rely~~or onpreliminary ~~third~~data ~~parties~~from toour ~~manufacture~~clinical ~~our~~trials ~~product~~that ~~candidates,~~we ~~which~~announce ~~subjects~~or uspublish from time to ~~risks~~time ~~and~~may ~~could~~change ~~delay~~as more patient data become available or ~~prevent~~as we make changes to our ~~development~~manufacturing processes and~~/or~~ ~~commercialization,~~are ifsubject ~~approved,~~to ofaudit ~~our~~and ~~product~~verification ~~candidates~~procedures that could result in material changes in the final data.

•We ~~rely~~acquired onImmPACT ~~third parties to assist~~ in ~~conducting~~October ~~and~~2024 ~~monitoring our clinical trials~~ and ~~for~~LYL273 ~~some~~in ofNovember ~~our~~2025 ~~research~~ and non-clinical studies for our product candidates, and, if those third parties do not successfully carry out their contractual duties, comply with regulatory requirements or otherwise perform satisfactorily, we may not berealize ~~able~~the tobenefits ~~obtain~~of ~~regulatory approval or commercialize product candidates, or~~ such ~~approval~~acquisitions or ~~commercialization~~any ~~may~~potential befuture ~~delayed~~collaborations, ~~and~~licenses, ~~our~~product ~~business~~acquisitions ~~may~~or beother ~~substantially~~strategic ~~harmed~~transactions.

•We ~~have~~face substantial competition in ~~the~~a ~~past,~~rapidly ~~and~~changing weindustry, which may result in ~~the~~others ~~future~~discovering, ~~form~~developing or ~~seek~~commercializing ~~collaborations~~products orbefore ~~strategic alliances~~ or ~~enter~~more ~~into~~successfully ~~additional~~than ~~licensing arrangements, and~~ we ~~may not realize the benefits of such alliances or licensing arrangements~~do.

•WeThe ~~depend~~manufacturing ~~on the enrollment and retention~~ of ~~patients~~cell intherapies ~~our~~is ~~current~~very ~~and~~complex. ~~planned~~We ~~clinical~~are ~~trials~~subject ~~for~~to ~~our~~a ~~product~~multitude ~~candidates.~~of Ifmanufacturing werisks, ~~experience~~any ~~delays~~of orwhich ~~difficulties~~could ~~enrolling~~substantially orincrease ~~retaining patients in~~ our ~~clinical trials~~costs, delay our ~~research~~programs ~~and~~or ~~development~~limit ~~efforts~~supply ~~and business, financial condition and results~~ of ~~operations~~our ~~could~~product ~~be materially adversely affected~~candidates.

•WeCell-based ~~face~~therapies ~~substantial~~rely ~~competition~~on inthe ~~rapidly~~availability ~~changing~~of ~~industries~~specialty raw materials, which may ~~result~~not inbe ~~others~~available ~~discovering,~~to ~~developing~~us oron ~~commercializing~~acceptable ~~products~~terms ~~before~~ or ~~more~~at ~~successfully than we do~~all.

•We currently manufacture drug products for our clinical trials ourselves. Delays in further qualifying or in receiving regulatory approvals for any manufacturing facility or product candidates, or in expanding our manufacturing capacity, could delay our development plans and thereby limit our ability to generate product revenues.

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•~~Our~~If ~~cellular~~our ~~therapy~~clinical ~~product~~manufacturing ~~candidates~~facility ~~represent~~in ~~new~~Bothell, ~~therapeutic~~Washington ~~approaches~~or ~~that~~any ~~could~~of ~~result~~our inpotential ~~heightened~~contract ~~regulatory~~manufacturing ~~scrutiny,~~organizations ~~delays~~is indamaged ~~clinical~~or ~~development~~destroyed or ~~delays~~production inat ~~our~~these ~~inability~~facilities tois ~~achieve~~otherwise ~~regulatory approvals~~interrupted, ~~commercialization~~our orbusiness ~~payor~~would ~~coverage~~be ofnegatively ~~our product candidates~~affected.

•~~The~~We ~~results~~rely ofon ~~research,~~third ~~nonclinical~~parties ~~studies~~to orassist ~~earlier clinical trials are not necessarily predictive of future results, initial clinical results~~ in aconducting ~~clinical~~and ~~trial~~monitoring ~~may~~our ~~not be predictive of future results in the same~~ clinical ~~trial~~trials and ~~results~~for insome ~~one indication may not be predictive~~ of ~~results~~our toresearch beand ~~expected for the same product candidate in another indication. If~~ non-clinical ~~trials~~studies offor our product candidates, ~~fail~~and, toif ~~produce~~those ~~positive~~third ~~results~~parties ordo ~~demonstrate~~not ~~satisfactory~~successfully ~~safety~~carry ~~and~~out ~~efficacy,~~their atcontractual ~~the appropriate dose level or at all~~duties, wecomply ~~may~~with ~~incur~~regulatory ~~additional~~requirements ~~costs~~ or ~~experience~~otherwise ~~delays~~perform ~~in completing~~satisfactorily, orwe ~~ultimately~~may not be ~~unable~~able to ~~complete,~~obtain ~~the~~regulatory ~~development~~approval ~~and~~or ~~commercialization~~commercialize ~~of our~~ product candidates., ~~Any~~or ~~product~~such ~~candidate~~approval weor ~~advance~~commercialization ~~into clinical trials~~ may ~~not~~be ~~have~~delayed, ~~favorable~~and ~~results~~our inbusiness ~~later~~may ~~clinical~~be ~~trials~~substantially ~~or receive regulatory approval~~harmed.

•~~Interim,~~We ~~topline~~depend oron ~~preliminary~~the ~~data~~enrollment ~~from~~and ~~our~~retention ~~clinical~~of ~~trials~~patients ~~that~~in weour ~~announce~~current orand ~~publish~~planned ~~from~~clinical ~~time~~trials tofor ~~time~~our ~~may~~product ~~change~~candidates. asIf ~~more~~we ~~patient~~experience ~~data~~delays ~~become~~or ~~available~~difficulties enrolling or asretaining wepatients ~~make~~in ~~changes~~our toclinical trials, our ~~manufacturing~~research ~~processes~~ and ~~are~~development ~~subject~~efforts ~~to audit~~ and ~~verification~~business, ~~procedures~~financial ~~that~~condition ~~could~~and ~~result~~results inof ~~material~~operations ~~changes~~could inbe ~~the~~materially ~~final~~adversely ~~data~~affected.

•We ~~recently~~do ~~acquired ImmPACT~~ and ~~may~~will ~~not~~continue beto ~~able~~or intend to ~~successfully~~rely ~~integrate~~on ~~ImmPACT~~outside ~~into~~scientists ~~our~~and ~~business,~~clinical ~~including~~trial ~~manufacturing~~investigators ofand ~~IMPT~~their third-~~314~~party atresearch institutions for research and development and clinical testing of our ~~LyFE~~product ~~Manufacturing~~candidates. ~~CenterTM~~These scientists, orinvestigators ~~realize~~and ~~the~~institutions ~~benefits~~may ofhave ~~such~~other ~~acquisition~~commitments or ~~any~~conflicts ~~potential~~of ~~future collaborations~~interest, ~~licenses,~~which ~~product~~could ~~acquisitions~~limit orour ~~other~~access ~~strategic~~to ~~transactions.~~their expertise and harm our ability to leverage our technologies.

•~~Unstable~~We ~~market~~have ~~and~~in ~~economic~~the ~~conditions~~past, and we may ~~have~~in ~~serious~~the ~~adverse~~future, ~~consequences~~form onor ~~our~~seek ~~business,~~collaborations ~~financial~~or ~~condition~~strategic alliances or enter into additional licensing arrangements, and ~~stock~~we ~~price~~may not realize the benefits of such alliances or licensing arrangements.

•We are currently in clinical development of our product candidates, and our future success is dependent on the successful development and regulatory approval of our product candidates and any product candidates we acquire.

•Our cell therapy product candidates represent new therapeutic approaches that could result in heightened regulatory scrutiny, delays in clinical development or delays in our ability to achieve regulatory approvals, commercialization or payor coverage of our product candidates.

•If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our ability to commercialize our product candidates successfully and to compete effectively may be adversely affected.

•We have in-licensed a portion of our intellectual property from our partners and other third parties. If we breach any of our license agreements with these licensors, we could potentially lose the ability to continue the development and potential commercialization of one or more of our product candidates.

•We may be unable to comply with the applicable continued listing requirements of The Nasdaq Global Select Market.

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PART I

Item 1. Business.

Overview

We are a ~~clinical~~late-stage clinical cell therapy company ~~expecting to enter pivotal trials in 2025 and~~ advancing a pipeline of proprietary next-generation autologous chimeric antigen receptor (CAR) T-cell product candidates for patients with cancer. Our goal is to fully realize the curative potential of cell therapy for patients with hematologic malignancies and solid tumors. WeTo achieve this, we are pioneering novel approaches designed to generate T‑cell ~~cells~~therapies that drive long-lasting clinical responses. ~~The~~Our ~~patient’s~~CAR ~~own~~T-cell ~~living~~product ~~cells~~candidates ~~are~~start with the ~~starting~~identification ~~point~~of ~~for~~promising ~~our~~cancer ~~investigational~~targets. ~~CAR~~We ~~T-cell~~then ~~therapies,~~engineer ~~and~~the wepatient’s ~~enhance~~own living immune cells and arm them with our innovative enhancements, including CAR constructs, ~~technology~~technologies and manufacturing protocols that are designed to endow T cells with more potent cancer cell killing capabilities.

In hematologic malignancies, we are focused on ~~advancing~~delivering totherapies ~~pivotal~~that ~~trials~~provide apatients ~~product~~meaningfully ~~candidate designed to deliver~~ improved outcomes over currently approved, first-generation CD19 CAR T-cell ~~therapies for patients with B-cell lymphomas~~products. Our lead ~~program,~~product ~~IMPT-314~~candidate, ~~currently~~rondecabtagene ~~under~~autoleucel ~~evaluation~~(ronde-cel, ~~for~~also ~~the~~known ~~treatment~~as ~~of aggressive large B-cell lymphoma~~LYL314), is a dual-targeting CD19/CD20 CAR T-cell ~~product~~therapy ~~candidate~~ designed to increase complete response rates and prolong the duration of response as compared to the approved CD19‑targeted CAR T-cell therapies. ~~IMPT~~Ronde-~~314~~cel is designed with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency and is manufactured with a process that enriches for CD62L+‑positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity.

ToWe ~~realize~~are ~~the~~currently ~~potential~~conducting ofa ~~cell~~pivotal ~~therapy~~single-arm ~~for~~clinical ~~solid~~trial ~~tumors,~~(PiNACLE) weevaluating ~~are~~ronde-cel ~~also~~in ~~developing~~patients ~~next-generation~~with ~~CAR~~relapsed Tor refractory (R/R) large B-cell ~~product~~lymphoma ~~candidates~~(LBCL) ~~enhanced~~receiving ~~with~~treatment ~~our~~in ~~anti~~the third-~~exhaustion~~ ~~and~~or ~~additional~~later-line ~~arming~~(3L+) ~~technologies~~setting and ~~manufactured~~a ~~with~~Phase ~~our~~3 ~~proprietary~~randomized ~~protocols.~~controlled ~~These~~head-to-head ~~approaches~~CAR ~~are~~T-cell ~~designed~~therapy totrial ~~endow~~(PiNACLE-H2H) ~~CAR~~for Tpatients ~~cells~~ with ~~attributes~~LBCL ~~needed~~receiving totreatment ~~drive~~in ~~durable~~the ~~tumor~~second-line ~~cytotoxicity~~setting ~~and~~(2L). ~~achieve~~Patient ~~consistent~~dosing ~~and~~has ~~long~~commenced in the PiNACLE-~~lasting~~H2H ~~clinical~~Phase ~~responses~~3 trial, ~~including~~which ~~the~~randomizes ~~ability~~patients to ~~resist~~either ~~exhaustion,~~ronde-cel ~~maintain~~or ~~qualities~~investigator’s choice of ~~durable~~axicabtagene ~~stemness~~ciloleucel ~~and~~(axi-cel) ~~function~~or inlisocabtagene ~~the~~maraleucel ~~hostile tumor microenvironment~~(liso-cel).

InTo ~~October~~realize ~~2024~~the potential of cell therapy for solid tumors, in November 2025 we acquired ~~ImmPACT~~an exclusive global license for LYL273 (excluding mainland China, aHong ~~privately-owned~~Kong, ~~clinical~~Macau ~~stage~~and ~~biotechnology~~Taiwan), ~~company~~an ~~developing~~autologous ~~next~~guanylyl cyclase C (GCC)-~~generation~~targeted CAR T-cell product ~~candidates~~candidate previously known as GCC19CART, ~~including~~from ~~IMPT~~Innovative Cellular Therapeutics Holdings Limited and Innovative Cellular Therapeutics, Inc. (together, ICT). A 67% overall response rate and an 83% disease control rate with a manageable safety profile have been reported at the highest dose level tested to date in patients with advanced metastatic colorectal cancer (mCRC) in a U.S. Phase 1 clinical trial as of the data cutoff date of October 28, 2025. LYL273 is enhanced with CD19 CAR expression and controlled cytokine release designed to improve CAR T-~~314~~cell expansion, immune cell infiltration and cancer cell killing in the hostile tumor microenvironment. Clinical proof-of-concept for LYL273 was initially demonstrated in 15 patients with mCRC in an investigator-sponsored clinical trial conducted in China and published in JAMA Oncology (September 2024).

Our ~~pipeline~~research ofscientists are also developing next-generation CAR T-cell product candidates ~~target~~for ~~cancers~~additional solid tumor indications enhanced with ~~large~~our ~~unmet~~anti-exhaustion ~~need~~and additional arming technologies and manufactured with our proprietary protocols. These enhancements are ~~summarized~~designed to endow CAR T cells with attributes needed to drive durable tumor cytolytic activity and achieve high rates of long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in ~~Table~~the 1hostile ~~below:~~solid tumor microenvironment.

Table 1: Lyell’s Pipeline

Our Strategy

Our goal is to realize the potential of next-generation CAR T-cell therapies for patients with cancer. We are advancing an innovative CAR T-cell therapy for hematologic malignancies designed to improve outcomes over first‑generation products and are progressing the next wave of innovation of CAR T-cell therapy for solid tumors. Lyell was founded by leaders in the fields of oncology and cell therapy who have interrogated and elucidated the mechanisms of T‑cell biology and its interactions with cancer for decades. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to endow CAR T cells with attributes needed to drive durable tumor cytotoxicity and achieve

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~~consistent~~Our ~~and~~pipeline ~~long~~of next-~~lasting~~generation ~~clinical~~CAR ~~responses,~~T-cell ~~including~~clinical ~~the~~product ~~ability~~candidates totargets ~~resist~~cancers ~~exhaustion,~~with ~~maintain~~large ~~qualities~~unmet ofneed ~~durable stemness~~ and ~~function~~is summarized in ~~the~~Table ~~hostile~~1 ~~tumor microenvironment.~~ below:

~~Our~~Table ~~product~~1: ~~candidates~~Lyell’s ~~target~~Clinical carefully selected tumor antigens and are enhanced with our proprietary technologies and manufacturing protocols designed to generate potent, tumor-reactive, long-lasting and functional T cells to drive durable tumor cytotoxicity. Pipeline

Our Strategy

Lyell’s mission is to fully realize the curative potential of next-generation CAR T-cell therapies and meaningfully improve outcomes for patients with cancer. Today we are advancing next-generation innovative CAR T-cell therapies for patients with hematologic malignancies, including R/R LBCL, designed to improve outcomes over first‑generation products, and are aggressively progressing the next wave of cell therapy innovation for patients with solid tumors, including patients with advanced mCRC. To realize the potential of cell therapy for cancer, our product candidates target carefully selected tumor antigens or targets with high expression on cancer cells and low to no expression in normal tissues or that are inaccessible in normal tissues, to avoid on-target, off-tumor toxicity. We then arm our cells with enhancements to improve the CAR T cell’s ability to fight cancer. Specifically, we utilize enhancements, including the ability to resist exhaustion and maintain qualities of durable stemness, designed to improve the functional activity of T cells in the hostile tumor microenvironment to drive durable tumor cytolytic activity and achieve consistent and long-lasting clinical responses. Our product candidates are designed to be one-time CAR T-cell treatments that can achieve lasting remission for patients with cancer so they can return to their normal lives with extended disease-free, treatment-free periods.

Key components of our business strategy to achieve this goal include:

•Efficiently advance our ~~clinical~~lead late-stage ~~pipeline~~clinical ofprogram ~~next~~evaluating ronde-~~generation~~cel ~~CAR~~for ~~T-cell~~patients ~~product~~with ~~candidates~~LBCL — We believe our autologous dual-targeting CD19/CD20 CAR T‑cell ~~therapies~~product ~~have~~candidate, ronde-cel, has the potential to deliver improved, durable clinical outcomes for patients with ~~hematologic~~R/R ~~malignancies~~LBCL ~~and~~over ~~solid~~first‑generation ~~tumors.~~approved ~~Our~~CD19 ~~most advanced wholly‑owned~~ CAR T-cell ~~product~~therapies. ~~candidate, IMPT~~Ronde-~~314,~~cel ~~has~~is ~~the~~currently ~~potential~~under toevaluation ~~provide~~in ~~meaningfully~~a ~~differentiated~~pivotal ~~benefit~~single-arm trial, PiNACLE, in ~~overall~~the ~~and~~3L+ ~~complete~~setting. ~~response~~This ~~rates~~trial ~~and~~is ina ~~the~~seamless ~~duration~~expansion of the ~~responses~~3L+ ~~over~~cohort ~~first‑generation~~in ~~CD19~~our ~~CAR~~ongoing ~~T-cell~~Phase ~~therapies~~1/2 inclinical ~~patients~~trial ~~with~~and ~~relapsed/refractory~~is ~~aggressive~~expected ~~large~~to ~~B-cell~~enroll ~~lymphoma.~~approximately ~~IMPT-314~~120 ispatients ~~currently~~at inapproximately ~~Phase~~25 ~~1/2~~sites. ~~development,~~The ~~and~~primary weendpoint ~~recently~~is ~~reported~~the ~~positive~~best ~~initial~~overall ~~clinical~~response ~~data~~rate. inWe ~~patients~~have ~~with~~also ~~aggressive~~recently ~~large~~initiated Bthe first-~~cell~~of-its-kind ~~lymphoma~~Phase in3 ~~the~~randomized ~~3rd~~controlled ~~line~~head-to-head orCAR ~~later~~T-cell ~~(3rd~~therapy ~~line+)~~clinical ~~setting~~trial, PiNACLE-H2H. WePatient ~~expect~~dosing tocommenced ~~initiate~~in ~~two~~February ~~pivotal~~2026 ~~clinical~~in ~~programs:~~this ~~one~~trial, ~~for~~and ~~patients~~site ~~being~~activation ~~treated~~is underway in the ~~3rd~~United ~~line+~~States, ~~setting~~Canada inand ~~mid-2025,~~Australia. ~~and~~We ~~another~~expect ~~for~~to randomize approximately 400 patients in1:1 ~~the~~to ~~2nd~~either ~~line~~ronde-cel ~~setting~~or byinvestigator’s ~~early~~choice ~~2026~~of axi-cel or liso-cel. The primary endpoint is event-free survival.

~~•Advance~~We ~~novel~~recently ~~targets~~reported ~~and~~updated ~~technologies~~clinical todata ~~generate~~in apatients ~~robust~~with ~~pipeline~~aggressive ofLBCL ~~next-generation~~in ~~cell~~the ~~therapies~~3L+- ~~designed~~and ~~to deliver durable anti~~2L-~~tumor~~ ~~activity~~settings ~~for~~from ~~cancer~~a ~~indications~~multi-cohort ~~with~~multi-center ~~high~~Phase ~~unmet~~1/2 ~~medical~~clinical ~~need~~trial ~~and~~(NCT05826535) ofat ~~substantial~~the ~~market~~December ~~size~~2025 —American WeSociety ~~are committed to continuing the advancement~~ of ~~disruptive~~Hematology ~~technologies~~Annual ~~designed~~Meeting ~~to revolutionize cell therapy~~ and ~~its~~Exposition ~~promise~~(ASH to2025). ~~improve~~The ~~the~~oral ~~lives~~presentation ofincluded ~~patients~~updated ~~with~~data ~~hematologic~~from ~~malignancies~~the ~~and~~3L+ ~~solid~~cohort ~~tumors.~~(now Inthe ~~addition~~ongoing toPiNACLE ~~developing~~pivotal ~~novel~~trial) ~~CAR~~including ~~constructs~~a ~~that~~best ~~target~~overall ~~undisclosed~~response ~~tumor~~rate ~~antigen~~of ~~targets,~~93% weand ~~are~~a ~~advancing~~complete aresponse ~~suite~~rate of ~~stackable~~76% ~~proprietary technologies to arm T cells to overcome the barriers presented by solid tumors. Our preclinical programs under development target antigens~~ in ~~solid~~29 ~~tumors~~efficacy-evaluable ~~with~~patients ~~high unmet medical need in indications~~ with ~~substantial~~R/R ~~market size~~LBCL. WeThe ~~have~~median ~~previously validated our proprietary anti~~progression-~~exhaustion~~free ~~technology~~survival ~~and~~was ~~intend~~18 tomonths ~~stack~~as ~~newer~~of ~~technologies~~the ~~expressing~~data ~~novel~~cutoff ~~chimeric~~date ~~proteins~~of ~~designed~~September to5, ~~fully~~2025. ~~arm~~Updated ~~our~~data ~~CAR~~were ~~T-cell~~also ~~product~~presented ~~candidates~~from tothe ~~optimize~~2L ~~CAR~~cohort, ~~T‑cell~~including ~~killing~~18 inefficacy ~~the~~evaluable ~~hostile~~patients ~~tumor~~(94% ~~microenvironment~~with ~~and enable durable anti~~high-~~tumor~~risk ~~function~~primary inrefractory ~~the~~disease) ~~solid~~and ~~tumor~~demonstrated ~~setting. We anticipate submitting~~ an ~~Investigational~~83% ~~New~~best ~~Drug~~overall ~~(IND)~~response ~~application~~rate ~~for~~and a ~~second~~61% ~~CAR~~complete ~~T-cell~~response ~~product~~rate. ~~candidate~~The ~~armed~~safety ~~with~~profile ~~multiple~~was ~~proprietary technologies and targeting a solid tumor indication in 2026.~~

•Maintain state‑of‑the‑art infrastructure and expert capabilities to control and innovate cell product manufacturing — We have built and operate a dedicated manufacturing facility, the LyFE Manufacturing Center™ (LyFE), that produces cell product for our clinical trials. At full capacity, LyFE has the capacity to manufacture more than 1,000 CAR T-cell doses/year and therefore has the capability to support early commercial launch. We have invested in infrastructure that enables real‑time monitoring of our manufacturing processes and the ability to incorporate insights into our research, manufacturing and clinical development efforts. Through our recent acquisition of ImmPACT, we acquired the cell manufacturing facility based in Los Angeles that has produced all of the IMPT-314 doses used in clinical trials to date. As we accelerate development of IMPT-314, we are supplementing our Los Angeles manufacturing capacity through a manufacturing technology transfer to LyFE. Our manufacturing strategy includes seeking new ways to efficiently, rapidly and cost-effectively scale manufacturing capacity for our cell product candidates for future clinical trials and potential commercialization.

•Generate, secure and defend intellectual property on our differentiated technology platforms, CAR constructs and product candidates — We have developed and secured a robust suite of intellectual property, including know-how, through our internal research efforts, licensing agreements and collaborations. We rigorously analyze, file and protect our intellectual property in various jurisdictions around the world in an ongoing manner.

•Opportunistically pursue strategic opportunities to maximize the potential of our pipeline and capabilities – We consider a variety of ways to collaborate with external partners. Our technologies can be applied in a target and modality agnostic manner to CAR, tumor infiltrating lymphocyte (TIL) and T-cell receptor (TCR) therapies to improve the functionality of T cells. We will evaluate options for partnering programs, indications or geographies with pharmaceutical or biotechnology companies for the development and/or commercialization of our product candidates designed to address large patient populations. We also consider opportunities to acquire or license rights or invest in differentiated product candidates or technologies to complement our pipeline.

Our Pipeline Programs

We are advancing a pipeline of next-generation CAR T-cell product candidates, including our lead program, IMPT-314, that is in clinical development for aggressive large B-cell malignancies. Our preclinical programs target solid

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~~tumor~~appropriate ~~indications.~~for ~~Each~~outpatient administration of ~~our~~ronde-cel. ~~programs~~Data ~~target~~from ~~cancers~~25 patients treated with ~~large~~ronde-cel ~~unmet~~and ~~need~~receiving ~~with~~dexamethasone ~~substantial~~prophylaxis ~~patient~~revealed ~~populations~~no reports of Grade 3 or higher cytokine release syndrome (~~see~~CRS) ~~Table~~and 1one case (4%) of Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS).

•Efficiently advance our Phase 1 clinical program evaluating LYL273 for patients with advanced mCRC — We believe our autologous guanylyl cyclase C-targeting CAR T-‑cell ~~therapies~~product ~~have~~candidate, ~~demonstrated~~LYL273 ~~the~~(previously ~~curative~~known ~~potential~~as ofGCC19CART), ~~genetically~~enhanced with CD19 CAR expression and controlled cytokine release designed to improve CAR T-~~engineered~~cell ~~autologous~~expansion, immune cell ~~therapy~~infiltration ~~for~~and cancer. ~~CARs~~cell ~~are~~killing ~~synthetic~~in ~~receptors~~the ~~that~~hostile ~~link~~tumor anmicroenvironment, ~~extracellular~~has ~~antigen-binding~~the ~~moiety~~potential to deliver improved, ~~usually~~durable aclinical ~~single~~outcomes ~~chain~~for ~~variable~~patients ~~fragment~~with ~~(scFv)~~advanced ~~derived~~mCRC ~~from~~over acurrently ~~monoclonal~~approved ~~antibody,~~therapies toin ~~intracellular~~the ~~signaling~~3L+ ~~domains~~mCRC setting. ~~CARs~~A ~~redirect~~67% ~~T-cell~~best ~~functional~~overall ~~activity~~response rate, ~~including~~an ~~cytotoxicity~~83% ~~and~~disease ~~cytokine~~control ~~secretion,~~rate ~~toward~~and ~~cancer~~an ~~cells~~8-month ~~that~~median ~~share~~progression-free survival with a ~~common~~manageable ~~target~~safety ~~without~~profile ~~the~~have ~~limitation~~been reported as of ~~human~~the ~~leukocyte~~data ~~antigen~~cutoff ~~restriction~~date of October 28, 2025. LYL273 is currently undergoing evaluation in an ongoing Phase 1 trial to establish the recommended Phase 2 dose.

~~IMPT-314:~~•Advance Anovel targets and technologies to generate a robust pipeline of next-generation ~~dual-targeting~~cell ~~CD19/CD20~~therapies designed to deliver durable antitumor activity for cancer indications with high unmet medical need and of substantial market size — We are committed to continuing the advancement of disruptive technologies designed to achieve the promise of cell therapy to significantly improve the outcome for patients with hematologic malignancies and solid tumors. Our objective is to select promising CAR T-cell ~~product~~therapy ~~candidate~~targets that are highly expressed on cancers that impact a large number of patients with high unmet medical need, but not on normal tissues to avoid on-target, off tumor toxicity. We then arm the CAR T cells with enhancements designed to ~~increase~~optimize ~~complete~~cancer ~~response~~cell ~~rates~~killing. ~~and~~Specifically, ~~prolong~~our strategy centers around the ~~duration~~utilization of ~~responses~~enhancements, asincluding ~~compared~~the ability to resist exhaustion, maintain qualities of durable stemness and function in the ~~approved~~hostile ~~CD19‑targeted~~tumor ~~CAR~~microenvironment, designed to improve T- cell ~~therapies~~functional ~~for~~activity, ~~the~~drive ~~treatment~~durable oftumor ~~large~~cytolytic Bactivity and achieve consistent and long-~~cell~~lasting ~~lymphoma~~clinical responses.

~~Our~~•Maintain ~~lead~~state‑of‑the‑art ~~program,~~infrastructure ~~IMPT-314,~~and isexpert ~~targeting~~capabilities ~~patients~~to ~~with~~control ~~aggressive~~and ~~relapsed/refractory~~innovate ~~large B-~~cell ~~non-Hodgkin~~product ~~lymphoma~~manufacturing ~~(NHL).~~— ~~Lymphoma~~We ishave built and operate a ~~blood~~dedicated ~~cancer~~manufacturing facility, the LyFE Manufacturing Center™ (LyFE), that ~~begins~~produces incell ~~lymphocytes~~product ~~and~~for ~~spreads~~our ~~primarily~~clinical intrials. ~~lymph~~At ~~nodes,~~full ~~but~~staffing ~~can~~and ~~also~~capacity, ~~metastasize~~we expect LyFE to have the ~~liver,~~capacity ~~kidney~~to manufacture more than 1,200 ~~brain~~CAR T-cell doses/year and ~~other~~support ~~organs~~commercial launch. ~~Lymphomas~~We ~~are~~have ~~broadly~~invested ~~classified~~in asinfrastructure ~~either~~that ~~Hodgkin~~enables ~~or non~~real‑~~Hodgkin~~time ~~lymphoma,~~monitoring ~~with~~of ~~NHL~~our ~~present~~manufacturing inprocesses ~~multiple~~and ~~groups~~the ofability ~~lymph~~to ~~nodes~~incorporate ~~whereas~~insights ~~Hodgkin~~into ~~lymphoma~~our isresearch, ~~typically~~manufacturing ~~located~~and inclinical adevelopment ~~single~~efforts. ~~group~~Our ofmanufacturing ~~lymph~~strategy ~~nodes,~~includes ~~generally~~seeking innew ~~the~~ways ~~upper~~to ~~body.~~efficiently, ~~NHL~~rapidly isand ~~the~~cost-effectively ~~more~~scale ~~common~~manufacturing ~~form~~capacity offor ~~lymphoma,~~our ~~representing~~cell ~~approximately~~product ~~90%~~candidates offor ~~all~~future ~~lymphomas~~clinical trials and potential commercialization.

~~The American Cancer Society estimates that more than 80~~•Generate,~~000~~ ~~people~~secure ~~will~~and bedefend ~~diagnosed~~intellectual ~~with~~property ~~NHL~~on inour ~~the~~differentiated ~~United~~technology ~~States~~platforms, inCAR ~~2025~~constructs and ~~545,000~~product ~~will~~candidates be— ~~diagnosed~~We ~~worldwide.~~have ~~NHL~~developed ~~encompasses~~and secured a ~~diverse~~robust ~~group~~suite of ~~blood~~intellectual ~~cancers~~property, ~~with~~including ~~over 90 distinct subtypes~~know-how, ~~generally~~through ~~classified~~our ~~based~~internal onresearch ~~(i)~~efforts, ~~the~~licensing ~~type~~agreements ofand ~~lymphocytes~~collaborations. ~~involved~~We ~~(B-cell~~rigorously ~~or T-cell)~~analyze, ~~(ii)~~file ~~the~~and ~~lymphocytes’~~protect ~~phenotype,~~our ~~defined~~intellectual asproperty ~~large~~in ~~cell~~various orjurisdictions ~~small~~around ~~cell and (iii)~~ the ~~disease's~~world ~~rate~~in ofan ~~progression,~~ongoing ~~which can be characterized as either aggressive or indolent (Figure 1)~~manner.

We•Opportunistically ~~are~~pursue ~~initially~~strategic ~~focused~~opportunities onto ~~developing~~maximize ~~IMPT-314 for~~ the ~~treatment~~potential of ~~patients~~our ~~with~~pipeline ~~NHL~~and ~~subtypes~~capabilities ~~representing~~— ~~approximately~~We ~~35%~~consider ofa ~~the~~variety ~~over~~of ~~80,000~~ways ~~patients estimated~~ to becollaborate ~~diagnosed~~ with ~~NHL~~external ~~in the United States in 2025 and 545,000 patients worldwide~~partners. ~~The~~We ~~NHL~~evaluate ~~subtypes~~options wefor ~~intend~~partnering ~~to initially pursue include diffuse large B-cell lymphoma (DLBCL)~~programs, ~~primary~~indications ~~mediastinal~~or ~~large~~geographies ~~B-cell~~with ~~lymphoma~~pharmaceutical ~~(PMBCL),~~or ~~transformed~~biotechnology ~~follicular~~companies ~~lymphoma~~for ~~(tFL)~~the ~~and~~development ~~Grade 3B follicular lymphoma (FL3B). DLBCL~~ and/or ~~PMBCL~~commercialization ~~represent approximately 31% and 3%~~ of ~~patients~~our ~~diagnosed~~product ~~with~~candidates ~~NHL~~designed ~~each~~to ~~year,~~address ~~respectively,~~large ~~while~~patient ~~tFL~~populations. ~~and~~We ~~FL3B~~also ~~each~~consider ~~represent~~opportunities ~~approximately 1~~ to 2%acquire ofor ~~NHL~~license ~~patients~~rights ~~diagnosed~~or ~~with~~invest ~~follicular~~in ~~lymphoma~~differentiated ~~each~~product ~~year.~~candidates Weor ~~may~~technologies ~~choose~~ to ~~further~~complement ~~expand~~our ~~development to include additional NHL subtypes in the future~~pipeline.

Our Pipeline Clinical Programs

Rondecabtagene autoleucel (ronde-cel, also known as LYL314): A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of responses as compared to the approved CD19‑targeted CAR T-cell therapies for the treatment of large B-cell lymphoma

Ronde-Cel: Target Market and Approved Therapies

Our lead program, ronde-cel, is targeting patients with aggressive R/R large B-cell non‑Hodgkin lymphoma (NHL), more commonly referred to as LBCL. Lymphoma is a blood cancer that begins in lymphocytes and spreads primarily in lymph nodes, but can also metastasize to the liver, kidney, brain and other organs. Lymphomas are broadly classified as either Hodgkin or non‑Hodgkin lymphoma, with NHL present in multiple groups of lymph nodes whereas Hodgkin lymphoma is typically located in a single group of lymph nodes, generally in the upper body. NHL is the more common form of lymphoma, representing approximately 90% of all lymphomas.

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~~Figure 1: NHL is comprised of over 90 distinct subtypes, of which DLBCL is the most common form accounting for ~31% of all patients diagnosed with NHL.~~ We are initially focused on developing ~~IMPT~~ronde-~~314~~cel for the treatment of patients with NHL subtypes representing approximately 35% of the over 80,000 patients estimated to be diagnosed with NHL in the United States in 2025 and 545,000 patients worldwide. The NHL subtypes we ~~intend~~are tocurrently ~~initially~~pursuing ~~pursue~~ include diffuse large B-cell lymphoma (DLBCL), ~~transformed~~high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed FLfollicular lymphoma (tFL), transformed marginal zone B-cell lymphoma (tMZBCL), transformed mantle cell lymphoma (tMCL) and Grade 3B follicular lymphoma (FL3B). DLBCL represents approximately 31% of patients diagnosed with NHL each year (of which approximately 5% are HGBCL). PMBCL represents approximately 3% and FL3B and the transformed lymphomas represent approximately 1 to 2% of patients diagnosed with NHL each year. We may choose to further expand development to include additional NHL subtypes in the future.

~~The~~Of ~~majority~~the ofapproximately 30,000 patients ~~with~~in ~~NHL~~the ~~are~~U.S. ~~successfully treated~~ with ~~frontline~~LBCL, ~~combination~~40% ~~chemotherapy~~to or50% ~~targeted~~are ~~agents~~refractory to, ~~but~~or ~~some~~relapse dofollowing, ~~not~~first-line ~~stay~~treatment inand ~~remission~~we ~~for~~estimate approximately 12,000 ~~months~~to ~~(relapsed)~~15,000 ~~and~~patients ~~others~~in ~~fail~~the toUnited ~~achieve~~States awith ~~remission~~LBCL progress to ~~therapy~~2L ~~(refractory)~~treatment. ~~Aggressive~~We ~~lymphomas~~estimate ~~such~~the as3L+ ~~DLBCL~~patient ~~and~~population ~~other~~to ~~large~~be ~~B-cell~~approximately ~~lymphoma~~6,000 ~~subtypes~~to ~~are~~7,000 ~~more~~patients, ~~likely~~including up to ~~relapse~~50% orof bepatients ~~refractory~~who toprogress on first-line therapy. ~~Approximately~~and ~~40%~~receive ofa ~~patients~~second ~~with~~chemotherapy ~~DLBCL~~regimen ~~have~~prior ~~refractory~~to ~~disease~~CAR orwhile ~~relapse~~awaiting ~~after~~referral ~~their~~and/or ~~first~~apheresis ~~line~~scheduling of(Figure ~~treatment~~1).

~~Prior~~Figure to1: ~~the approval of CD19 CAR T~~Ronde-~~cell~~cel ~~therapies,~~is targeting the ~~prognosis of patients with relapsed/refractory aggressive large B~~multi-~~cell~~billion ~~lymphoma~~dollar was poor, with the then current standard of care resulting in overall response rates of 26% and complete response rates of 7%. The median overall survival was 6.3 months and only 20% of patients were alive at 2 years. The three currently approved CD19 CAR T-cell therapies, axicabtagene ciloleucel (axi-cel, YESCARTA®), tisagenlecleucel (tisa-cel, KYMRIAH®), or lisocabtagene maraleucel (liso-cel, BREYANZI®) transformed the treatment landscape by improving overall response rates (72%, 50% and 73%, respectively) with complete response rates (51%, 32% and 54%, respectively) in the 3rd line+ settingmarket.

While the first generation of CD19 CAR T-cell therapies delivered a major advance in treatment for patients with B-cell lymphoma, there remains a need for therapies that deliver more complete and durable responses. More than 40% of patients with aggressive ~~large~~LBCL ~~B-cell lymphoma~~ treated in the ~~3rd line~~3L+ setting with a CD19 CAR T-cell therapy are not disease-free after treatment and 30% of patients do not respond at all. Of these patients treated with an approved CD19 CAR T-cell therapy, approximately 50% of patients progress or ~~relapse~~die within six months, and the overall survival at one year for patients treated with a CD19 CAR T-cell therapy is only 50% to 60%. The median progression-free survival for the approved CD19 CAR T-cell therapies for patients in the 3L+-setting is 6 to 7 months. Importantly, the pivotal trials in the 3L+ setting for axi-cel and liso-cel did not enroll patients over the age of 75, and the axi-cel ZUMA-1 trial did not allow patients to receive bridging therapy between apheresis and CAR T-cell therapy infusion, potentially excluding patients who were progressing too rapidly to wait for CAR T-cell therapy manufacturing.

In the 2L setting, the ZUMA-7 randomized controlled trial of axi-cel versus standard of care chemoimmunotherapy did not enroll patients above the age of 75 and the only bridging therapy allowed was steroids. In ZUMA-7, the complete response rate was 65% and the median progression-free survival in all enrolled patients was 14.7 months. For those with primary refractory disease, the median progression-free survival was only 7 months. The complete response rate for patients with primary refractory disease was not reported. Liso-cel was evaluated in two pivotal trials conducted in the 2L setting. The first pivotal trial was a randomized controlled trial of liso-cel versus standard of care chemoimmunotherapy (TRANSFORM) which did not enroll patients over the age of 75, but did allow bridging therapy with chemotherapy. The complete response rate was 66% and the median progression-free survival was 14.8 months in the

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~~IMPT~~liso-~~314~~cel isarm. anData ~~autologous~~for ~~dual~~patients with primary refractory disease in the 2L were not reported from this trial. The second pivotal single-~~targeting~~arm ~~CD19/CD20~~trial ~~CAR~~conducted Tfor liso-~~cell~~cel ~~therapy~~(PILOT), ~~designed~~did toallow ~~kill~~patients Bover ~~cells~~the ~~expressing~~age ~~CD19~~of 75 and/ included patients ineligible for transplant with primary refractory disease, relapse before 12 months or ~~CD20~~relapse ~~antigens~~after 12 months to enroll into the trial. The complete response rate in the overall patient population was 54% and was 42% in the primary refractory patient population. The package insert for YESCARTA® lists the ~~treatment~~rate of ~~patients~~Grade ~~with~~3 ~~aggressive~~or ~~B-cell~~higher ~~malignancies~~CRS as 9% and the rate of Grade 3 or higher neurotoxicity as 31%. WeThe ~~acquired~~package ~~this~~insert ~~product~~for ~~candidate~~BREYANZI® ~~through~~lists ~~our~~the ~~acquisition~~rate of ~~ImmPACT~~Grade in3 ~~October~~or ~~2024~~higher CRS as 3% and the rate of Grade 3 or higher neurotoxicity as 10%.

AThe ~~dual-targeting,~~approved orCD19 ~~bispecific,~~ CAR ~~recognizes two targets. IMPT~~T-~~314~~cell istherapies ~~rationally~~for ~~designed~~NHL ~~with~~are aexpected ~~true~~to ~~CD19/CD20~~achieve ~~“OR”~~worldwide ~~logic-gated~~sales ~~CAR~~in ~~targeting~~2026 ~~either~~of ~~CD19~~approximately orfour ~~CD20~~billion ~~with~~dollars. ~~full~~YESCARTA® ~~potency,~~has ~~and~~been the ~~cell~~market ~~therapy~~leader ~~product~~since isapproval, ~~enriched~~but ~~for~~recently ~~naive~~BREYANZI® ~~and~~has ~~central~~been ~~memory~~gaining Tmarket ~~cells. Together~~share, ~~this~~presumably ~~novel~~due ~~construct~~to ~~and~~lower ~~the~~rates ~~cell~~of ~~enrichment~~neurotoxicity. ~~for~~This ~~naïve~~“switching” ~~and~~behavior ~~central~~of ~~memory~~CAR T-cell ~~cells~~therapy ~~are~~prescribers ~~designed~~has toalso ~~provide~~been reported in the multiple ~~clinical~~myeloma ~~benefits~~market ~~over~~with ~~CD19~~CARVYKTI® ~~CAR~~taking ~~T-cell~~market ~~therapies~~share from ABECMA®, ~~including:~~presumably due to enhanced efficacy (Figure 2).

~~•Ability~~Figure to2: ~~target~~CAR ~~lower~~T-cell ortherapy ~~heterogenous~~treating ~~CD19~~physicians ~~antigen~~have ~~density~~a ~~and~~historical ~~result~~willingness into a“switch” ~~higher~~CAR ~~percentage~~T-cell oftherapies ~~complete~~based ~~responses~~on ~~than~~the ~~with~~strength aof ~~single~~efficacy ~~targeting~~and ~~CAR~~safety ~~agent;~~clinical data.

~~•Increase~~Ronde-Cel: inMechanism ~~duration~~ of ~~responses by preventing relapse due to CD19 antigen escape~~Action

~~•Better~~Ronde-cel is an autologous dual-targeting CD19/CD20 CAR T-cell ~~engraftment,~~therapy ~~persistence~~designed to kill B cells expressing CD19 and/or ~~reduced~~CD20 ~~exhaustion~~antigens tofor ~~provide~~the ~~longer~~treatment ~~duration~~of patients with aggressive B-cell malignancies. We acquired this product candidate through our acquisition of ~~responses~~ImmPACT Bio USA Inc. (ImmPACT) in October 2024.

~~IMPT~~A dual-~~314~~targeting, ~~consists~~or ofbispecific, ~~autologous~~tandem TCAR ~~cells~~recognizes ~~that~~two ~~are~~targets ~~genetically~~with ~~modified~~a ~~through~~single ~~transduction~~construct. ~~with~~Ronde-cel ais ~~lentiviral~~rationally ~~vector~~designed ~~expressing~~with a ~~CAR~~true ~~construct composing anti-~~CD19/CD20 ~~and~~“OR” ~~anti~~logic-~~CD20~~gated ~~scFvs~~CAR intargeting ~~tandem~~either ~~and~~CD19 anor ~~intracellular~~CD20 ~~portion~~with ~~that~~full ~~contains~~potency, and the T cell ~~signaling~~therapy ~~zeta~~product ~~chain~~is ~~(CD3-ζ)~~enriched ~~and~~for ~~the~~naïve ~~4-1BB~~and ~~co-stimulatory~~central ~~domain~~memory ~~(Figure~~T 2)cells. ~~This~~Together, ~~differentiates~~this ~~IMPT-314~~novel ~~from~~construct ~~cell therapies~~ and ~~other~~the ~~therapeutic~~cell ~~modalities~~enrichment ~~that~~for ~~singularly~~naïve ~~target~~and ~~CD19,~~central ~~CD20~~memory orT ~~CD22,~~cells orare ~~bispecific~~designed ~~CARs~~to ~~that~~provide ~~target~~multiple ~~two~~clinical ~~antigens~~benefits ~~but~~over ~~without~~CD19 ~~full~~CAR ~~potency as compared to single~~T-~~targeting~~cell ~~CARs.~~therapies, including:

~~Figure~~•Ability ~~2: IMPT-314 contains separate, tandem single-chain variable fragment (scFV) antibody domains designed~~ to target ~~both~~lower or heterogeneous CD19 ~~and~~antigen ~~CD20~~density and isresult ~~manufactured~~in ~~using~~ a ~~CAR~~higher ~~that~~percentage ~~contains~~of ~~the~~complete ~~4-1BB~~responses ~~costimulatory~~than ~~domain and is manufactured~~ with a ~~process to enrich for CD62~~single-~~positive~~targeting ~~naïve~~CAR ~~and central memory T cells.~~construct;

~~Antigen~~•Increase ~~heterogeneity, which refers to variation~~ in the ~~expression~~duration ~~levels~~ of ~~tumor~~responses ~~antigens~~by ~~across~~preventing ~~cancer~~relapse ~~cells,~~due can limit the effectiveness of targeted therapies, including CD19 CAR T-cell therapy. Nonclinical data demonstrated that IMPT-314’s optimized tandem CAR design is capable of killing target cells that express CD19 only, CD20 only or both antigens with full potency, thus it has the potential to ~~achieve a higher percentage of complete responses than a single targeting agent, particularly in those patients with lymphoma who may have a lower or heterogeneous~~ CD19 antigen ~~density.~~escape; and

~~CD19~~•Better antigen escape, a mechanism by which tumor cells evade the host immune system or targeted therapy through loss, downregulation or modification of target antigens, is a known mechanism contributing to disease relapse. CD20 expression has been shown to be more stable following single-targeted CAR T-cell ~~treatment~~expansion, aspersistence ~~compared to CD19~~ and ~~CD22.~~reduced ~~IMPT-314’s~~exhaustion ~~dual-targeting of both CD19 and CD20 was designed~~ to ~~overcome~~provide ~~CD19~~longer ~~antigen escape and potentially prolong the~~ duration of responses~~, as well as to target those malignant B-cells that have limited or no expression of CD19 to achieve a higher overall response rate~~.

~~Additionally, IMPT~~Ronde-~~314~~cel isconsists ~~manufactured~~of toautologous ~~produce~~T cells that are genetically modified through transduction with a lentiviral vector expressing a tandem CAR Tconstruct composed of anti-~~cell~~CD19 ~~product~~and ~~with~~anti-CD20 ~~higher~~single-chain ~~proportions~~variable offragments ~~naïve~~(scFvs) in tandem and ~~central~~an ~~memory~~intracellular portion that contains the T-cell ~~cells~~signaling ~~through~~zeta achain ~~process~~(CD3-ζ) ~~that~~and ~~enriches~~the ~~for~~4-1BB ~~CD62L~~co-~~expressing~~stimulatory ~~cells~~domain (Figure 3). This ~~manufacturing~~differentiates ~~process~~ronde-cel isfrom cell therapies and other therapeutic modalities that singularly target CD19, CD20 or CD22.

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~~designed~~Figure to3: ~~generate~~Ronde-cel ~~CAR~~contains ~~T cells with enhanced antitumor activity~~separate, ~~which~~tandem wescFV ~~believe~~antibody ~~could~~domains ~~result~~designed into target both ~~increased~~CD19 ~~complete response rates~~ and ~~more~~CD20 ~~durable responses. Naïve T cells are mature T lymphocytes that have differentiated in the bone marrow~~ and ~~undergone~~is ~~central~~manufactured ~~tolerance~~using ~~selection~~a ~~in the thymus, but have not interacted with their antigen.~~ CAR Tconstruct ~~cells~~that ~~generated~~contains ~~from~~a ~~these CD62L~~4-~~positive~~1BB ~~less~~costimulatory ~~differentiated~~domain Tand ~~cells~~is ~~have~~manufactured ~~been associated~~ with ~~better~~a ~~engraftment,~~process ~~improved persistence, reduced exhaustion and lower cytokine production compared~~ to ~~CAR~~enrich Tfor ~~cells generated from traditional processes. The enrichment of~~ CD62L-~~expressing~~positive T cells does not increase the manufacturing time, which is similar to that of the approved CD19 CAR T-cell therapies. Data from the ZUMA-7 pivotal trial of axicabtagene ciloleucel in patients with relapsed or refractory large B-cell lymphoma demonstrated an improved overall survival in those patients with a higher median percentage of T cells with a naïve~~/stem~~ ~~memory~~and ~~phenotype~~central inmemory ~~the~~T ~~administered cell product~~cells.

~~ImmPACT~~Antigen ~~licensed~~heterogeneity, ~~its~~which ~~dual-targeting~~refers ~~CD19/CD20~~to ~~CAR~~variation ~~T-cell~~in ~~product candidate from~~ the ~~University~~expression levels of ~~California~~tumor ~~Los~~antigens ~~Angeles~~across ~~(UCLA).~~cancer ~~Interim~~cells, ~~Phase~~can 1limit ~~data~~the ineffectiveness 13of ~~patients~~targeted ~~with~~therapies, ~~relapsed/refractory~~including ~~aggressive~~CD19 ~~NHL treated in a UCLA‑sponsored single-center clinical trial were initially published and updated data were presented (Figure 3).~~ CAR T‑-cell ~~naïve patients with relapsed/refractory DLBCL or PMBCL after at least two lines of~~ therapy ~~or MCL, or FL were evaluated~~. ~~Autologous~~Nonclinical Tdata ~~cells~~demonstrated ~~were~~that ~~obtained and enriched for CD62L~~ronde-~~positive~~cel’s ~~naïve~~optimized ortandem ~~memory~~CAR Tdesign ~~cells.~~is ~~Two~~capable ~~doses~~of ~~were~~killing totarget ~~be evaluated including 50 and 200 million~~ cells. ~~Three~~that ~~patients~~express ~~received~~CD19 ~~cell~~only, ~~doses~~CD20 ~~below~~only 50or ~~million~~both ~~cells~~antigens ~~due to manufacturing issues. The overall response rate was 92%~~ with afull ~~complete response rate of 77% (10/13 patients). The median progression-free survival was 50.1 months~~potency, ~~and~~thus ~~median~~it ~~overall~~has ~~survival~~the ~~was~~potential ~~not~~to ~~reached~~achieve ~~with~~ a ~~median~~higher ~~follow‑up~~percentage of 32complete ~~months~~responses ~~(range:~~than ~~5.7~~a – not estimable). The overall survival at three years was 65%. A favorable safety profile was observed with no cases of cytokine release syndrome (CRS) above Grade 1 and no reported cases of immune effector cellsingle‑~~associated~~targeting ~~neurotoxicity~~agent, ~~syndrome~~particularly ~~(ICANS).~~in ~~Two~~those patients inwith ~~this~~malignant ~~study~~B ~~who~~cells ~~achieved~~with a ~~complete~~lower ~~response~~or ~~but~~heterogeneous ~~experienced disease progression after approximately 18 months and four years respectively were both successfully retreated with the UCLA~~ CD19~~/CD20~~ ~~CAR~~antigen ~~T-cell product and both patients again achieved a complete response~~density.

~~Figure~~CD19 3:antigen ~~Interim~~escape, ~~Phase~~a 1mechanism ~~data~~by inwhich 13tumor ~~patients~~cells ~~with~~evade ~~relapsed/refractory~~the ~~aggressive~~host ~~NHL~~immune ~~treated~~system ~~with~~or ~~UCLA-314~~targeted intherapy through loss, downregulation or modification of target antigens, is a ~~UCLA‑sponsored~~known ~~clinical~~mechanism ~~trial~~contributing ~~were~~to ~~presented~~disease atrelapse. Ronde-cel’s dual-targeting of both CD19 and CD20 was designed to overcome CD19 antigen escape and potentially prolong the ~~2024~~duration ~~American~~of ~~Association~~responses, ~~for~~as ~~Cancer~~well ~~Research~~as ~~Special~~to ~~Conference~~target malignant B cells with limited or no expression of CD19 to achieve a higher overall response rate. In a nonclinical xenograft model of mixed tumor cells (75% CD19-positive/CD20-positive, 25% CD19-negative/CD20-positive), mice treated with CAR T cells that targeted CD19 and CD20 in ~~Cancer~~this ~~Research:~~manner ~~Tumor~~eliminated ~~Immunology~~tumors and ~~Immunotherapy~~overcame a subsequent tumor re-challenge, whereas CD19 CAR T-cell treatment failed to control the tumors.

~~UCLA~~Additionally, ~~licensed~~ronde-cel ~~the~~is ~~CD19/CD20~~manufactured ~~dual-targeting~~to produce a CAR ~~construct~~T-cell product with higher proportions of naïve and central memory T cells through a process that enriches for CD62L-expressing cells. CD62L is a surface protein that acts as a homing beacon, guiding white blood cells to ~~ImmPACT~~sites of inflammation. CD62L enrichment in ronde-cel’s manufacturing process substitutes for the CD4/CD8 enrichment step in traditional CAR T-cell manufacturing, ~~who~~and ~~developed~~generates acell ~~GMP~~products that are comprised of more than 95% naïve or central memory T cells. This manufacturing process is designed to generate CAR T cells with enhanced antitumor activity, which we believe could result in both increased complete response rates and ~~initiated~~more adurable ~~Phase~~responses. ~~1/2~~Naïve ~~clinical~~T ~~trial~~cells are mature T lymphocytes that have differentiated in the bone marrow and undergone central tolerance selection in the thymus, but have not interacted with their ~~product~~antigen. ~~candidate~~CAR ~~IMPT~~T cells generated from these CD62L-~~314.~~positive Weless ~~acquired~~differentiated ~~ImmPACT~~T incells ~~October~~have ~~2024~~been associated with better cell expansion, improved persistence, reduced exhaustion and ~~are~~lower ~~continuing~~adverse cytokine production compared to CAR T cells generated from traditional processes. The enrichment of CD62L-expressing T cells does not increase the ~~development~~manufacturing time, which is similar to that of ~~IMPT~~the approved CD19 CAR T-~~314~~cell therapies with a median vein to site time of 16 days. Data from the ZUMA-7 pivotal trial of axi-cel in patients with R/R LBCL demonstrated an improved overall survival in those patients with a higher median percentage of T cells with a naïve/stem memory phenotype in the administered cell product.

During ASH 2025, we orally presented translational data from our ongoing Phase 1/2 ~~Clinical~~clinical ~~Trial~~trial that showed that ronde-cel manufactured with CD62L-positive enriched cells achieved robust expansion and high expression of ~~IMPT~~memory-~~314~~related genes after infusion in patients with LBCL. An evaluation of ronde-cel and published data for approved CD19 CAR T-cell products demonstrated that ronde-cel had a higher proportion of CD62L-positive T cells with a higher proportion of memory-cell phenotype prior to infusion (ronde-cel, N = 34; axi-cel, N = 110; and tisagenlecleucel (tisa-cel), N = 31). In addition, ronde-cel had up to a three-fold higher expansion in patients after infusion compared to the expansion of approved CD19 CAR T-cell products. Ronde-cel product memory-cell phenotype was positively correlated with expansion. Peripheral blood samples collected from patients one month after infusion (N = 9) also had a higher proportion of CAR T cells with a memory phenotype compared to cells from axi-cel-treated patients (N = 4). Ronde-cel CAR-positive

Our ongoing Phase 1/2 trial of IMPT-314 is a multi-center, open-label dose-escalation and dose-expansion clinical trial designed to evaluate the safety and clinical benefit of IMPT-314 and to determine a recommended Phase 2 dose in patients with relapsed/refractory aggressive large B-cell lymphoma. IMPT-314 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory aggressive large B-cell lymphoma

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inT ~~the~~cells ~~3rd~~collected ~~line+~~from ~~setting. The trial is enrolling~~ patients ~~with~~one ~~relapsed/refractory~~(N ~~DLBCL,~~= ~~PMBCL, high-grade B-cell lymphoma (HGBCL~~7), ~~FL3B~~ and ~~tFL.~~two ~~The~~months ~~trial~~(N is= ~~enrolling~~3) ~~CAR~~after ~~T-cell~~infusion ~~therapy~~demonstrated ~~naïve~~sustained ~~patients~~capacity into ~~the 3rd line+ and 2nd line settings. If successful~~proliferate, wekill ~~may~~tumor ~~expand~~cells ~~into~~over ~~other~~72 ~~types~~hours ofand ~~B-cell~~secrete ~~NHL~~cytokines.

~~Phase~~Ronde-Cel: ~~1/2~~ Clinical ~~Data~~Development Strategy

WeOur ~~reported initial data from the~~ ongoing Phase 1/2 trial ~~at the American Society~~ of ~~Hematology~~ronde-cel ~~2024~~is ~~Annual~~a ~~Meeting (ASH). As of October 22~~multi-cohort, ~~2024 (the data cutoff date for the presentation at ASH)~~multi-center, 23open-label ~~patients with relapsed or refractory CAR T~~dose-~~naive~~escalation ~~large~~and Bdose-~~cell~~expansion ~~lymphoma~~clinical ~~received~~trial ~~IMPT-314~~designed ~~and~~to ~~comprised~~evaluate the safety ~~population.~~and ~~The~~clinical ~~efficacy~~benefit ~~evaluable population consisted~~ of 17ronde-cel ~~patients~~(NCT05826535). ~~and~~We ~~was~~presented ~~defined~~positive asdata, ~~patients~~detailed ~~with~~below, afrom ~~response~~the ~~assessment~~3L+ atand ~~Day~~2L 84cohorts orfrom ~~later~~the orongoing anPhase ~~earlier~~1/2 ~~scan~~trial ~~with~~during aan ~~complete~~oral ~~response~~presentation orat ~~progressive~~ASH ~~disease~~2025. OfBased ~~the~~on ~~six~~these ~~patients not included in the efficacy evaluable population presented at ASH~~data, ~~two~~as ~~were~~well ~~excluded~~as ~~because~~our ~~they~~recent ~~had T~~End-~~cell histiocyte~~of-~~rich~~Phase ~~lymphoma,~~1 ameetings ~~histologic subtype~~ with athe ~~poor~~U.S. ~~prognosis~~Food ~~that~~and isDrug ~~not~~Administration ~~included in the clinical trial moving forward~~(FDA), ~~and~~we ~~four~~announced ~~patients~~the ~~who~~initiation ~~had~~of ~~not~~two ~~yet~~pivotal ~~reached~~trials ~~their~~of ~~Day~~ronde-cel: 84PiNACLE ~~scan~~and PiNACLE-H2H.

The ~~demographic~~PiNACLE ~~and~~trial ~~baseline~~(Figure ~~characteristic~~4), ~~data~~which ~~from~~is ~~the~~underway and enrolling patients, ~~enrolled~~is ~~into~~a seamless expansion of the 3L+ cohort of our Phase 1/2 trial. ~~demonstrated~~PiNACLE is a ~~median~~single-arm ~~age~~pivotal trial evaluating ronde-cel at a dose of 65100 ~~(range,~~x 21106 –CAR ~~87)~~T ~~years,~~cells in patients with LBCL treated in the ~~majority~~3L+ ~~(61%)~~setting. ofThe trial is expected to enroll approximately 120 patients with R/R DLBCL, ~~and~~PMBCL, aFL3B ~~median~~or oftFL ~~three~~who have received two or more prior lines of therapy ~~(range~~and have not received CAR T-cell therapy. Patients may be treated with ronde-cel in the inpatient or outpatient setting, 2with –observation 6)near the site limited to 14 days. ~~Approximately~~There ~~50%~~is no upper age limit for eligibility, which broadens the addressable patient population. The primary endpoint of ~~patients~~the ~~had~~trial ~~elevated~~is ~~lactate~~the ~~dehydrogenase~~best ~~levels~~overall ~~suggesting~~response ~~high~~rate, ~~disease~~including ~~burden~~an ~~and~~evaluation ~~53%~~of duration of ~~patients~~response. ~~received~~More ~~bridging~~information ~~therapy~~about the PiNACLE trial can be found on clinicaltrials.gov (NCT05826535).

~~The overall response rate for the efficacy evaluable patients was 94% (16/17 patients), with 71% (12/17 patients) achieving a complete response by three months (Table 2 and~~ Figure 4).: AtThe ~~the~~PiNACLE ~~time~~single-arm ~~the~~pivotal ~~data~~trial ~~were presented, three of those four patients were continuing on in the study~~schematic. The ~~median~~PiNACLE ~~follow~~trial upis ~~was~~expected ~~6.3~~to ~~months~~enroll ~~(range~~approximately ~~1.2~~120 ~~– 12.5 months) and 71% of~~ patients ~~were~~with ~~experiencing~~R/R ~~a response when these data were reported~~LBCL. NCT05826536

~~Table 2: Best overall response in~~ CAR, ~~T-cell~~chimeric ~~therapy~~antigen ~~naïve~~receptor; ~~patients~~Cy, incyclophosphamide; ~~the~~DLBCL, ~~3rd~~diffuse ~~line+~~large ~~cohort~~B-cell inlymphoma; ~~the~~3BFL, ~~initial~~Grade ~~data~~3B ~~presented~~follicular atlymphoma; ~~the~~Flu, ~~2024~~fludarabine; ~~American~~PMBCL, ~~Society~~primary ofmediastinal ~~Hematology~~B-cell ~~annual meeting~~lymphoma. ~~Data cutoff October 22, 2024.~~

The PiNACLE-H2H trial is a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial that will evaluate ronde-cel versus investigator’s choice of approved CD19 CAR T-cell therapies (axi-cel or liso-cel) in patients with R/R LBCL receiving treatment in the 2L setting. Patients randomized to ronde-cel will be treated with a dose of 100 x 106 CAR T cells. The primary endpoint of the trial is event-free survival. The trial is expected to enroll approximately 400 patients with R/R LBCL (200 per arm), including DLBCL, PMBCL, HGBCL, FL3B, tFL, tMCL or tMZBCL who have not previously received CAR T-cell therapy. Patients may be treated with ronde-cel in either the inpatient or outpatient setting. Patient dosing commenced in February 2026, and clinical site activation is ongoing in the United States, Canada and Australia. More information about the PiNACLE-H2H trial can be found on clinicaltrials.gov (NCT07188558). Now that the PiNACLE-H2H trial is enrolling patients, the 2L cohort in our Phase 1/2 multi-cohort trial is no longer recruiting patients.

In the future, we may expand into other types of B-cell NHL.

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Figure 45: ~~Initial~~The ~~data~~PiNACLE-H2H ~~from the~~ Phase ~~1/2~~3 ~~trial~~randomized incontrolled ~~patients~~head-to-head ~~with~~CAR ~~relapsed/refractory aggressive large B~~T-cell ~~lymphoma~~therapy ~~treated~~trial ~~with~~of ~~IMPT~~ronde-~~314~~cel ~~were~~versus ~~presented~~investigator’s atchoice ~~American Society~~ of ~~Hematology~~axi-cel ~~2024~~or ~~Annual Meeting 2024~~liso-cel. The efficacy evaluable population consisted of 17 patients. The overall response rate was 94% (16/17 patients), with 71% (12/17 patients) achieving a CR by three months. The median follow up was 6.3 months (range 1.2 – 12.5 months) and 71% of patients were experiencing a response when these data were reported.

In the safety evaluable population of 23 patients, no Grade 3 or greater CRS was reported. Grade 3 ICANS was reported in 13% (3/23) of patients with a median time to complete ICANS resolution of five days, and rapid improvement to Grade 2 or lower with standard therapy. Four patients had Grade 3 infections including bacteremia not otherwise specified, tooth infection, urinary tract infection and a herpes zoster infection, all of which responded to treatment and resolved. Pharmacokinetic data were available from 16 of the efficacyRonde-~~evaluable~~Cel: ~~patients.~~Clinical Data

~~IMPT-314~~We ~~demonstrated~~presented ~~robust~~new ~~expansion~~clinical and ~~peak~~translational ~~cell~~data ~~expansion~~from ~~occurred~~our ~~between~~ongoing ~~Days~~Phase 71/2 ~~and~~clinical 28trial ~~after~~of ~~IMPT~~ronde-~~314~~cel ~~infusion~~in ~~(median~~patients ~~Tmax~~with =LBCL 10at ~~days)~~ASH 2025. ~~Median~~The ~~peak~~trial ofis ~~expansion~~a ~~(Cmax)~~multi-cohort, ~~was~~multi-center 93dose-escalation,~~723~~ ~~copies/µg~~dose-expansion ~~gDNA~~trial. ~~(range~~Patients ~~2,338~~had –not ~~555,284).~~previously ~~IMPT~~received CAR T-~~314~~cell ~~cells~~therapy ~~persisted~~and ~~multiple~~there ~~weeks~~was ~~post~~no ~~infusion~~upper ~~across~~age ~~multiple~~limit ~~patients~~nor ~~with~~requirement ~~median~~for ~~expansion~~CD19/CD20 atscreening ~~Day~~prior 28to ofenrollment. 11Data were presented from the 3L+ and 2L cohorts. Bridging therapy was optional and lymphodepletion included fludarabine,~~766~~ ~~copies~~30 mg/µgm2 ~~gDNA~~and ~~(range~~cyclophosphamide, 56500 ~~– 555~~mg/m2,~~284)~~ each for three days. The ~~median~~cell ~~peak~~manufacturing ~~expansion~~median ofvein ~~IMPT-314~~to issite ~~approximately~~time ~~four‑fold~~was ~~higher~~16 ~~than~~days and the ~~median~~recommended ~~peak~~Phase ~~expansion~~2 ~~reported~~dose ~~for~~was ~~lisocabtagene~~established ~~maraleucel,~~at a100 ~~CD19~~x 106 CAR T~~-cell~~ ~~therapy~~cells. ~~approved~~Two ~~for~~ patients ~~with~~were ~~relapsed~~treated orat ~~refractory~~Dose ~~(R/R)~~Level ~~large~~2 ~~B-cell~~(300 ~~lymphoma.~~x ~~Greater~~106 CAR T~~-cell~~ ~~expansion~~cells). ~~has~~Imaging ~~been~~response ~~associated~~assessments ~~with~~were ~~improved~~conducted ~~treatment~~locally ~~response~~at inDay ~~patients~~28, ~~with~~Month ~~B-cell~~3 ~~lymphoma.~~and ~~Additionally,~~every ~~the~~three ~~final~~months ~~drug~~for ~~product~~24 ~~contained~~months. ~~the~~The ~~desired~~trial ~~naïve~~objectives ~~and~~were ~~central~~safety ~~memory~~and ~~cell~~tolerability, ~~phenotype~~best ~~(median,~~overall ~~91%;~~response ~~range,~~rate 82and –complete ~~99%)~~response ~~that~~rate, ~~has~~duration ~~been~~of ~~associated~~response, ~~with~~selection ~~improved~~of ~~overall~~the ~~survival~~recommended inPhase ~~other~~2 ~~CAR~~dose T‑and cell ~~clinical~~expansion ~~studies~~pharmacokinetics.

~~Based~~Sixty-nine onpatients ~~these~~with ~~promising~~R/R ~~initial~~LBCL ~~and~~received ~~emerging~~ronde-cel as of September 5, 2025 (the data ~~from~~cutoff date for the ~~Phase~~presentation ~~1/2~~at ~~IMPT-314~~ASH ~~clinical~~2025). ~~trial~~Patient demographics and ~~following~~baseline ~~appropriate~~disease ~~regulatory~~characteristics ~~interactions~~were consistent with a high-risk, weheavily ~~intend~~pre-treated patient population, particularly as compared to ~~initiate~~historical atrials ~~pivotal~~of ~~trial~~CD19 CAR T-cell products: median ages of 64 and 65 years with 16% (6/37) and 21% (5/24) of patients being 75 years or older in the ~~3rd line~~3L+ ~~setting~~and 2L settings, respectively; and primary refractory disease in ~~mid-2025~~43% (16/37) and a92% ~~pivotal~~(22/24) ~~trial~~of patients in the ~~2nd~~3L+ ~~line~~and 2L settings, respectively. The efficacy evaluable population, defined as those patients with Day 84 assessments or prior disease progression or death, consisted of 47 patients (29 in the 3L+ setting byand ~~early~~18 ~~2026~~in the 2L setting).

~~Target~~Patients ~~Markets~~Treated with Ronde-Cel in the 3L+ Setting

~~We are initially developing IMPT-314 for the treatment of aggressive large B-cell NHL. NHL is a common blood cancer in the United States and worldwide.~~ There ~~are~~were ~~more~~29 than 60 NHL subtypes that have been identified by the World Health Organization. Aggressive lymphomas grow and spread quickly and cause more severe symptoms, and these account for approximately 60% of all NHL cases. B‑cell lymphoma is the most common type of NHL, comprising approximately 85% of all lymphomas in the United States. We are initially focusing on the subtypes classified as large Befficacy-~~cell~~evaluable ~~lymphomas;~~3L+ ofpatients ~~these~~with ~~diffuse~~R/R ~~large~~LBCL ~~B-cell lymphoma~~ (DLBCL~~) is the most common. Annually~~, ~~it is estimated that approximately 80~~PMBCL,~~000~~ ~~people~~3BFL inor ~~the~~tFL) ~~United~~with ~~States~~a ~~and~~median ~~545,000~~follow ~~worldwide~~up ~~will~~time beof ~~diagnosed~~12 ~~with~~months ~~NHL.~~as ~~Approximately 200,000 cases~~ of ~~DLBCL are expected to be treated in~~ the ~~U.S.,~~data ~~European~~cutoff ~~Union (EU), United Kingdom (UK), China and Japan in 2025, with approximately 24,000 and 13,000 patients receiving treatment in the 2nd and 3rd line and later settings, respectively, in the U~~date.S. ~~and~~The ~~approximately~~data ~~62,000~~are ~~and~~presented ~~24,000 patients receiving treatment~~ in ~~the~~Figure ~~2nd~~6 and ~~3rd~~summarized ~~line and later settings,~~ here:

•The best overall response rate was 93% (27/29 patients), with 76% (22/29) of patients achieving a complete response

•72% (13/18) of patients with complete response remained in complete response at 6 months or longer

•Median progression-free survival was 18 months

The PiNACLE single-arm pivotal trial is a seamless expansion of this 3L+ cohort and is ongoing. The trial design is presented in Figure 4. Patients with HGBCL are no longer included in the PiNACLE single-arm trial to focus the trial on those patients most likely to achieve high durable response rates. The response rate and duration of response in patients enrolled with HGBCL (N = 8) was shorter than that observed for patients with other histologies.

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~~respectively,~~Figure in6: ~~the~~High ~~U.S.,~~rates ~~EU,~~of ~~UK,~~durable ~~China~~complete ~~and~~responses ~~Japan.~~were ~~Today,~~observed ~~the~~in ~~approved~~patients ~~CD19~~treated ~~CAR~~with Tronde-~~cell~~cel ~~therapy~~in ~~products~~the ~~have~~3L+ ~~worldwide projected sales of approximately $3 billion and this is expected to nearly double by 2030~~setting.

~~Beyond DLBCL~~3L+, ~~other subtypes of B~~third-~~cell~~ ~~NHL~~or ~~that could be evaluated in future trials of IMPT~~later-~~314~~line ~~include FL~~setting, ~~MZL and MCL~~LBCL, ~~where~~large ~~approximately~~B-cell ~~200,000, 79,000 and 38,000 patients are expected to be treated in the U~~lymphoma.~~S., EU, UK, China and Japan in 2025.~~

~~Our~~Patients ~~Preclinical~~Treated ~~Programs~~with Ronde-Cel in the 2L Setting

There were 18 efficacy-evaluable patients enrolled in the 2L setting with a median follow-up time of 9 months as of the data cutoff date. Of these efficacy-evaluable patients, 94% had primary refractory disease. Data from these patients are presented in Figure 7 and summarized here:

•The overall response rate was 83% (15/18 patients), with 61% (11/18) achieving a complete response

•70% (7/10) of patients with complete response remained in complete response at ≥ 6 months

•The median duration of complete response was not reached

Figure 7: High rates of durable complete responses were observed in patients treated with ronde-cel in the 2L setting.

2L, second-line setting, LBCL, large B-cell lymphoma.

Safety Data

In 69 patients, including all patients from both the 3L+ and the 2L cohorts, a manageable safety profile appropriate for outpatient administration was observed. No Grade 3 or higher CRS was observed. Twenty-five of the 69 patients received protocol-directed dexamethasone prophylaxis (10 mg/day for 3 days). One case (4%) of Grade 3 or higher ICANS was reported in a patient with high disease burden; no case of Grade 2 ICANS was reported.

In all 69 patients, as of the data cutoff date, low rates of Grade 1 (32%) or Grade 2 (29%) CRS were reported; ICANS rates were reported as follows: Grade 1 (9%), Grade 2 (3%) and Grade 3 or higher (12%) of patients. The median time to complete resolution of all reports of ICANS was 4 days. Cell pharmacodynamic data demonstrated robust CAR T‑cell expansion and persistence that were similar in patients with or without dexamethasone prophylaxis. No deaths were determined to be related to ronde-cel administration. Data are presented in Figure 8.

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Figure 8: Adverse events of interest with and without dexamethasone prophylaxis for patients in both the 3L+ and 2L settings.

CRS, cytokine release syndrome; HGBCL, high grade B-cell lymphoma; ICANS, immune effector cell-associated neurotoxicity; IEC-HS, immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome; IV, intravenous; LDH, lactate dehydrogenase; PO, per os (oral).

Pharmacokinetic Data

Pharmacokinetic data evaluating ronde-cel cell expansion using the droplet digital polymerase chain reaction (ddPCR) method are presented in Figure 9. The data showed robust cell expansion with or without dexamethasone prophylaxis (dexamethasone 10 mg by oral or intravenous administration once daily for 3 days) with no significant differences observed in peak CAR T-cell expansion (Cmax) or overall exposure (AUC) between patients who received dexamethasone (N = 25) and those who did not (N = 42).

Figure 9: Ronde-cel cell expansion was robust in patients who did or did not receive dexamethasone prophylaxis, 10 mg by oral or intravenous administration daily for three days.

CAR, chimeric antigen receptor; ddPCR, digital droplet polymerase chain reaction; DNA, deoxyribonucleic acid; IQR, interquartile range; LLOQ, lower limit of quantitation; LLOD, lower limit of detection.

Assay used for measuring B cells/µl (Epiontis ID®) can detect as low as 2 cells/µl with high accuracy.

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Ronde-cel has received Regenerative Medicine Advanced Therapy designation as well as Fast Track designation from the FDA for the treatment of adults with R/R DLBCL in the 3L+ setting and has also received RMAT designation for the treatment of LBCL in the 2L setting. The FDA has also granted ronde-cel Orphan Drug Designation for the treatment of DLBCL/HGBCL with MYC and BCL2 rearrangements.

Based on the clinical data observed to date and an End-of-Phase 1 meeting with the FDA, we have initiated the Phase 3 randomized controlled head-to-head CAR T-cell trial evaluating ronde-cel versus investigator’s choice of an approved CD19 CAR T-cell therapy (axi-cel or liso-cel).

LYL273 (formerly known as GCC19CART): Guanylyl cyclase C-targeted CAR T-cell product candidate for the treatment of mCRC and other GCC-expressing cancers

We acquired an exclusive global license, outside of mainland China, Hong Kong, Macau and Taiwan, from ICT for a next-generation GCC-targeted CAR T-cell product candidate (LYL273, formerly GCC19CART) with promising dose-dependent clinical activity, including a 67% best overall response rate, disease control rate of 83% and a median progression-free survival of 8 months in patients with advanced mCRC in a Phase 1 trial conducted in the U.S. The U.S. Investigational New Drug (IND) and Phase 1 trial initiation were supported by single-center data from an investigator‑sponsored study of 15 patients conducted in China and published in JAMA Oncology in 2024. LYL273 is a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. LYL273 was granted Fast Track designation for the treatment of mCRC by the FDA.

LYL273: Target Market and Approved Therapies

Colorectal cancer is the second leading cause of cancer deaths worldwide, and the incidence of colorectal cancer is rising in people younger than 55 years old. In the United States, there were estimated to be 154,000 total new colorectal cancer diagnoses and about 1 in 5 of these diagnoses will occur in people younger than 55 years old. Approximately 53,000 people were expected to die from CRC in the U.S. in 2025. Approximately 25% of patients have metastatic disease at the time of diagnosis and up to 60% of patients diagnosed with colorectal cancer will develop distant metastases at some point during their disease journey.

Despite the remaining tremendous unmet medical need for new effective therapies for mCRC, the worldwide net sales for currently approved CRC products is expected to reach 12 billion dollars by 2032 (Figure 10). However, the benefit of approved therapies for mCRC in the 3L+ setting is limited. With the approved products, only six percent or less of patients achieve a partial or complete response to their next line of therapy, the median progression-free survival is 6 months or less and the median overall survival is 11 months or less (Figure 10).

Figure 10: The worldwide market for therapies approved for colorectal cancer is six billion dollars and growing. However, currently approved standard-of-care therapies in the 3L+ setting do not achieve meaningful response rates and provide limited survival benefit.

LYL273: Mechanism of Action

LYL273 is a GCC-targeted CAR T-cell therapy armed with enhancements including CD19 CAR expression and release of multiple cytokines in a controlled manner upon T-cell activation. Together, these enhancements were designed to increase CAR T-cell expansion, immune cell infiltration and cancer cell killing (Figure 11). GCC is a receptor that plays a key role in the regulation of intestinal electrolyte homeostasis. It is expressed on more than 95% of colorectal cancers and a majority of pancreatic adenocarcinomas. Its expression in healthy tissue is limited to the gastrointestinal tract, where it is sequestered by tight junctions from the circulation.

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There are currently no CAR T-cell therapies approved to treat patients with solid tumors. LYL273 was specifically designed to overcome two key barriers that have previously prevented successful treatment of solid tumors with CAR T‑cell therapies. The first is lack of sufficient in vivo CAR T-cell expansion to allow for adequate tumor infiltration. The second is inhibition of antitumor activity such as tumor cell killing and cytokine production due to the hostile tumor immunosuppressive or “cold” tumor microenvironment. GCC is an excellent target because it is highly expressed in the vast majority of colorectal cancers and metastases and expressed at lower levels in normal gut tissue and generally inaccessible to the circulation. However, our approach is to arm CAR T-cell therapies with additional enhancements to increase the CAR T cell’s ability to kill cancer cells.

LYL273 is a single product consisting of a mixture of three key cell types: GCC CAR T cells, CD19 CAR T cells that release specific cytokines upon activation and doublet cells that have both GCC and CD19 CAR expression. Upon activation, these doublet cells are also engineered to release either interferon gamma (IFNγ), interleukin 12 (IL-12) or interleukin-6 (IL-6). The CD19 CAR expressing T cells engage B cells and jumpstart CAR T-cell activation and cell expansion upon infusion. As the CAR T cells infiltrate into the cancer, the cytokines enhance further cell expansion, remodel or “warm up” the suppressive tumor microenvironment and enhance immune cell infiltration and cancer cell killing. The level of cytokines is carefully regulated by specific vector design and usage during manufacturing. The Miltenyi CliniMACS PRODIGY® closed, automated manufacturing system is used to manufacture LYL273 and it is a standardized 7-day manufacturing process that is easily transferable and scalable.

A. B.

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Figure 11: A. LYL273 is a GCC-targeted CAR T-cell product candidate armed with enhancements including CD19 and the controlled release of cytokines including IFNγ, IL-12 and IL-6. B. It is a single product enhanced with three key CAR T-cell types including GCC CAR T cells, CD19 CAR T cells that release cytokines upon activation and engagement of B cells. C. LYL273 is designed to enhance in vivo cell expansion and to remodel the tumor microenvironment to improve tumor infiltration and cancer cell killing.

LYL273: Clinical Development Strategy

LYL273 is under evaluation in an ongoing Phase 1 clinical trial to determine the recommended Phase 2 dose and regimen, and to determine the tolerability and pharmacokinetics of LYL273. The IND was filed and the trial initiated based upon 15 patients with refractory mCRC from an investigator-sponsored study in China published in JAMA Oncology, 2024. Patients were evaluated at either Dose Level 1 (1 x 106 CAR-positive cells/kg; N = 8) or Dose Level 2 (2 x 106 CAR‑positive cells/kg; N = 7). Across both dose levels, the overall response rate was 40% (6/15). The disease control rate was 73%. At Dose Level 2, the median overall survival was 25 months (95% confidence interval [CI] of 13.4 to 26.1) and the median progression-free survival was 6 months (95% CI, 3.0 to not applicable). No deaths occurred during the study period. Adverse events of interest included CRS (86%, Grade 1 or 2), ICANS (14%, Grade 4), diarrhea (57%, Grade 3, all resolved), leukopenia (57%, Grade 3). Prior to these data, ICT reported unpublished data in 20 patients at various doses with various manufacturing processes across multiple different centers in China. During the study treatment period, five deaths were reported at these trial sites. The trial was subsequently focused at one expert center with CAR T-cell therapy experience.

LYL273: Clinical Data

Response Rates

The U.S. Phase 1 clinical trial is ongoing at four centers in the United States, including the Dana Farber Cancer Institute, the University of California, San Francisco Comprehensive Cancer Center, the University of Colorado Cancer Center and the City of Hope Comprehensive Cancer Center. Patients with refractory mCRC treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor therapy and anti-epidermal growth factor receptor therapy for RAS wild-type tumors and checkpoint inhibitor treatment for microsatellite-instability high or mismatch repair deficient tumors are eligible if they have one measurable lesion per Response Evaluation Criteria for Solid Tumors, version 1.1. Liver metastases are allowed, but limited to no more than seven lesions with the largest lesion less than 3 cm. The patient must be determined to have no surgical options with curative intent. A single dose of lymphodepleting chemotherapy consisting of cyclophosphamide, 300 mg/m2, and fludarabine, 30 mg/m2 is administered prior to CAR T-cell infusion.

Two dose levels have been evaluated as of the data cutoff date of October 28, 2025 and include Dose Level 1 at 1 x 106 CAR T cells/kg (N = 6 patients) and Dose Level 2 at 2 x 106 CAR T cells/kg (N = 6 patients). The patients enrolled had a median age of 49 (range, 39 to 57), had a median of 3 prior lines of therapy (range, 2 to 6), with 25% receiving prior treatment with LONSURF® and 100% receiving prior treatment with AVASTIN®. All patients were microsatellite stable and 33% had disease with RAS mutations.

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The best overall response rate was 50% (6 of 12 patients) and the disease control rate was 83% across both dose levels. At Dose Level 2, the highest dose tested, the best overall response rate was 67%, including one patient with a pathological complete response, one patient with complete reduction in tumor volume of the target lesions (100% partial response) and two additional patients with confirmed partial responses (Figure 12). For patients treated at Dose Level 2, the disease control rate was 83%, and the median progression-free survival was 7.8 months.

Figure 12: In a U.S. Phase 1 clinical trial, the overall response rate was 50% (6 of 12 patients) and the disease control rate was 83% across both dose levels. At Dose Level 2, the highest dose tested, the overall response rate was 67%, including one patient with a pathological complete response, one patient with complete reduction in tumor volume of the target lesions (100% partial response) and two additional patients with confirmed partial responses. For patients treated at Dose Level 2, the disease control rate was 83%, and the median progression-free survival was 7.8 months.

Safety Data

In this trial, the incidence and severity of treatment-related adverse events were highest at Dose Level 2, where the most common adverse events were cytokine release syndrome in 83% (5/6) of patients (Grade 1, 67%; Grade 2, 17%) and diarrhea in 83% (5/6) of patients (Grade 1, 33%; Grade 2, 33%; Grade 3, 17%) as of the data cutoff date of October 28, 2025. The median duration of diarrhea was 11 days. Immune effector cell-associated neurotoxicity syndrome occurred in 33% (2/6) of patients (Grade 2, 17%; Grade 3, 17%) and resolved rapidly with treatment. One patient experienced a dose‑limiting toxicity at Dose Level 2, including Grade 3 diarrhea, Grade 4 enterocolitis and death from fungal sepsis 48 days post-infusion. No Grade 3 or higher diarrhea occurred in the last three patients treated since establishing an optimized management protocol for diarrhea, including prophylaxis with vedolizumab, infliximab and budesonide.

Pharmacokinetic Data

LYL273 is a single product candidate consisting of a mix of three key cell types including GCC CAR T cells, CD19 CAR T cells and GCC/CD19 doublet CAR T cells. A consistent cell expansion profile was observed across patients, as exemplified by the cell expansion data from Patient 11 who achieved a 100% partial response (Figure 13). All three cell types expanded, with the high level of expansion observed in the doublet cell population which accounted for more than 80% of all GCC CAR-expressing T cells at peak. After 21 days, the steadily expanded GCC CAR T cells made up the majority CAR T cells in peripheral blood.

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Figure 13: LYL273 cell expansion data from Patient 11 in the U.S. Phase 1 clinical trial. The plot shows the proportion of T cells in the peripheral blood of each of the three key cell types comprising LYL273.

Our Nonclinical Programs

Cell therapy has demonstrated profound results in some patients suffering from hematologic malignancies, but there remains a need for therapies that deliver more complete and durable responses. Solid tumors are even more complex and have evolved multiple mechanisms to evade and ultimately resist clearance by the immune system. This has limited the use of cell therapy in solid tumors, which account for 90% of cancer deaths. And while there has been recent progress with new cell therapies approved for solid tumors, overall response rates and the duration of response remain low.

ToWe ~~complement our clinical programs, we~~ continue to invest in earlier stage cell therapy research and development utilizing our proprietary technologies. We ~~expect~~are toadvancing ~~submit an IND application in 2026 for~~ a ~~new,~~ fully-armed solid tumor CAR T-cell product candidate with aan ~~new~~undisclosed target, ~~anti-~~with the CAR T cells enhanced by multiple technologies, each designed to address different barriers to effective cell therapies, including T‑cell exhaustion, ~~and~~lack of durable stemness ~~technologies~~, as well as aimmune ~~new~~suppression ~~technology~~within ~~designed to overcome~~ the hostile tumor microenvironment.

Our T-cell Enhancement and Manufacturing Technologies

AtFor ~~Lyell, we believe that careful selection and evaluation of~~ our ~~CAR~~solid ~~targets~~tumor isnonclinical ~~important~~pipeline, ~~to ensure~~ we are ~~aiming~~targeting ~~for~~large ~~larger~~ markets with substantial unmet medical need. We carefully evaluate and select CAR targets to ensure that binding to normal tissues is limited and manageable for safety. Selecting an appropriate antigen target and designing a potent CAR construct, however, are necessary but insufficient for achieving durable clinical responses in most solid tumors. Based on nonclinical evidence and clinical data, we believe there are multiple mechanisms limiting the efficacy and durability of cell therapy for solid tumors. ~~To address this need, we are advancing solid tumor CAR~~ T~~‑cell~~ ~~product~~cells ~~candidates~~require ~~with~~three ~~new~~different ~~CAR~~types ~~targets and that are armed with a suite~~ of ~~proprietary~~signals ~~anti-exhaustion~~for ~~and~~optimal ~~durable~~immune ~~stemness~~activation: ~~technologies, as well as new enhancements designed to overcome the hostile tumor microenvironment.~~

~~T-cell~~•Signal ~~exhaustion~~1: ~~remains a major barrier for the development of effective CAR T~~Antigen-~~cell~~specific ~~therapy.~~recognition We+ ~~have~~CD3ζ previously demonstrated Lyell’s proprietary anti-exhaustion technology improves anti-tumor functions in in vitro and in vivo preclinical models. In patients with triple-negative breast cancer we have shown that our anti-exhaustion technology reduces T-cell exhaustion and improves CAR T-cell pharmacokinetics and tumor infiltration. Recently, alternative approaches that arm CAR T cells with transforming growth factor beta (~~TGF-β~~zeta) blockade or constitutive cytokine signaling to enhance their anti-tumor functionality in the suppressive tumor microenvironment have shown promise in the solid tumor settings. In addition to developing novel CAR constructs targeting undisclosed tumor antigen targets, our research activities explore stacking these additional approaches to our proprietary anti-exhaustion technology via the expression of novel chimeric protein or polypeptide to optimize CAR T-cell killing in the hostile tumor microenvironment for application in future solid tumor product candidates.chain

~~Our~~•Signal ~~technologies~~2: ~~and~~Co-stimulation ~~manufacturing~~such ~~approaches~~as ~~designed~~with toCD28 ~~generate~~or ~~CAR T cells that can achieve potent and durable anti~~4-~~tumor~~1BB ~~cytotoxicity~~to ~~are~~augment ~~summarized~~Signal ~~in Table 3 described below.~~1

13•Signal 3: Cytokine signaling

Our aim in designing a fully-armed CAR T-cell candidate is to optimize each signaling pathway with one or more enhancements from our suite of novel technologies to optimize CAR T-cell activation and function. Our next-generation CAR T-cell product candidates are fully-armed, meaning they incorporate multiple technologies, each designed to address different efficacy barriers to cell therapies for solid tumors, including T‑cell exhaustion, lack of durable stemness and insufficient cell expansion, as well as immune suppression within the hostile tumor microenvironment. Our technologies and manufacturing approaches, designed to enhance CAR T-cell function so they can achieve potent and durable cancer cell killing, are summarized in Table 2.

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Table 32: Lyell ~~has~~CAR aT-Cell ~~suite~~Enhancements ofDesigned ~~technologies designed~~ to ~~enhance~~Augment the ~~potency~~Potency and ~~durability~~Durability of our CAR T-~~cell~~Cell ~~product~~Product ~~candidates~~Candidates.

~~Two~~Lynn, ofR. ~~our~~et ~~technologies~~al., ~~c-Jun~~Nature, ~~overexpression~~2019; ~~and~~Chen, ~~our~~J. ~~Epi-R~~et ~~manufacturing~~al., ~~protocol~~Nature, ~~have~~2019; ~~been~~Cheung ~~clinically~~A. ~~validated~~et inal., aNature ~~Phase~~Biotechnology 12018; ~~study~~Li inA. ~~patients~~et ~~with triple-negative breast cancer~~al., ~~and~~Scientific weReports ~~are~~2024; ~~advancing~~Arcangeli anet ~~additional~~al., ~~anti‑exhaustion~~JCI ~~technology~~2022, ~~knockout~~Sommermeyer ofet ~~NR4A3~~al., byLeukemia ~~gene editing~~2016, ~~that~~Chen ~~has~~et ~~demonstrated~~al., ~~even~~Cancer ~~more~~Discovery ~~potent~~2021, ~~anti-tumor~~Aldoss ~~functionality~~et ~~in nonclinical models~~al. ~~More recently~~, weClin ~~have~~Cancer ~~explored~~Res ~~new~~2023. ~~strategies~~AP-1, toactivator ~~express~~protein-1; ~~novel~~CAR, chimeric ~~proteins~~antigen-receptor; toNR4A3, ~~optimize~~nuclear ~~CAR~~receptor T4A3; TGF-~~cell~~β, ~~killing~~transforming ingrowth ~~the~~factor ~~hostile~~beta, TME, tumor microenvironment.

Two of our technologies, c-Jun overexpression and our Epi-R manufacturing protocol, have been clinically validated in a Phase 1 trial in patients with triple-negative breast cancer, and we are advancing an additional anti‑exhaustion technology, knockout of NR4A3 by gene editing, that has demonstrated even more potent antitumor functionality in nonclinical models. More recently, we have explored new strategies to express novel chimeric proteins to improve CAR T-cell killing in the hostile tumor microenvironment.

c-Jun Overexpression

Overexpression of c-Jun is based on the work of our co-founder, Crystal Mackall, M.D., the Ernest and Amelia Gallo Family Professor of Pediatrics and Medicine at Stanford University (Stanford) and Founding Director of the Stanford Center for Cancer Cell Therapy. Dr. Mackall discovered that exhausted T cells have an imbalance in the AP‑1 family of transcription factors, and that correcting for this imbalance by overexpression of c-Jun enables T cells to resist exhaustion, infiltrate solid tumors, and maintain their functionality and potency. This work was fully described in a Nature publication in 2019. Overexpression of c-Jun was recently validated in a Phase 1 clinical ~~study~~trial where a ROR1-targeted CAR T-cell ~~products~~product overexpressing c-Jun demonstrated clinical responses, improved pharmacokinetics, less CAR T-cell exhaustion and CAR T-cell tumor infiltration on histologic examination of on-study tumor biopsies. These data demonstrated improvement over the clinical data from a prior ~~study~~trial conducted at the Fred Hutchinson Cancer Center (Fred Hutch) of a similar ROR-1 CAR T-cell product, but without c-Jun overexpression, in a similar patient population where no responses were observed after a single CAR T-cell treatment and high levels of CAR T-cell exhaustion occurred rapidly.

NR4A3 Gene Knockout

NR4A3 gene knockout builds on the approach of reprogramming of the AP-1 transcription factor pathway to delay exhaustion and improve antitumor function. We and others have previously observed that the NR4A family of transcription factors is upregulated in exhausted T cells and may contribute to T‑cell exhaustion, in part by restricting the activity of AP-1. We hypothesize that disruption of NR4A3 expression, along with c-Jun overexpression, may further unleash the potential for maximal c-Jun activity and endow greater functional resistance to exhaustion. Our nonclinical data suggest the combination of these two technologies, NR4A3 gene knockout and c-Jun overexpression, can act in a complementary fashion and may have the potential to further improve the potency and durability of our CAR therapy ~~(Figure 5)~~.

Epi-R Manufacturing Protocol

Epi‑R is our proprietary ex vivo manufacturing protocol that is designed to generate populations of ~~stem-like~~stemlike T cells with reduced exhaustion and improved proliferation and antitumor activity. T cells with properties of durable stemness have an increased ability to self-renew and persist to drive durable tumor cytotoxicity. We developed this technology based upon the science conducted at the National Cancer Institute, where it was demonstrated that products with more and functional T cells can be achieved by altering the metabolic state of the cells during expansion.

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~~stemness have an increased ability to self~~CD62L-~~renew~~Positive and persist to drive durable tumor cytotoxicity. Lyell developed technology based upon the science conducted at the National Cancer Institute, where it was demonstrated that products with more stem-like and functional T cells can be achieved by altering the metabolic state of the cells during expansion. Enrichment

Our lead product candidate, ronde-cel, is manufactured with a process that enriches for CD62L-positive ~~Positive~~cells. ~~Enrichment~~This manufacturing process is designed to generate CAR T cells with enhanced antitumor activity that we believe could result in both higher complete response rates and more durable responses. Naïve T cells are CD62L-positive mature T lymphocytes that have differentiated in the bone marrow and undergone central tolerance selection in the thymus, but have not interacted with their antigen. CAR T cells generated from these CD62L-positive less differentiated T cells have been associated with better cell expansion, improved persistence, reduced exhaustion, and lower cytokine production compared to CAR T cells generated from traditional processes. The enrichment of CD62L-positive T cells does not increase the manufacturing time, which is similar to that of the approved CD19 CAR T-cell therapies.

~~Our~~Dual ~~lead product candidate, IMPT-314 is manufactured with a process that enriches for CD62L positive cells. This manufacturing process is designed to generate~~ CAR T cells with enhanced antitumor activity that we believe could result in both increased complete response rates and more durable responses. Naïve T cells are CD62L positive mature T lymphocytes that have differentiated in the bone marrow and undergone central tolerance selection in the thymus, but have not interacted with their antigen. CAR T cells generated from these CD62L positive less differentiated T cells have been associated with better engraftment, improved persistence, reduced exhaustion and lower cytokine production compared to CAR T cells generated from traditional processes. The enrichment of CD62L positive T cells does not increase the manufacturing time, which is similar to that of the approved CD19 CAR T-cell therapies.Expression

~~Stim~~Our clinical candidates are designed to target more than a single antigen. Ronde-Rcel ~~Technology~~expresses a tandem “OR” gated CAR to target both CD19 and CD20 that are expressed on B-cell lymphoma. This approach was designed to improve the complete response rate, as well as durability of response for patients with aggressive lymphoma. LYL273 is composed of several key CAR T-cell populations, including a novel doublet CAR T-cell population that expresses both GCC-targeted and CD19-targeted CARs. Upon infusion, expression of the CD19 CAR enables B-cell engagement that jumpstarts doublet CAR T-cell activation, cytokine release and cell expansion. Improved expansion may facilitate tumor infiltration and cancer cell killing.

Stim‑R is our proprietary synthetic-cell mimetic composed of lipid-coated silica micro-rods that mimic the physiological cell-like presentation of signals to control T-cell activation in the manufacturing process. Current manufacturing platforms typically utilize antibody-conjugated beads that were developed decades ago for expanding T cells. This standard approach does not provide precise control over the strength or duration of the signaling that drives T‑cell expansion ex vivo. Our Stim‑R platform optimizes signaling parameters during T‑cell activation using degradable lipid-coated silica rods that can be functionalized to regulate cell activation, more closely mimicking natural T‑cell stimulation. This technology allows for greater control over the duration, intensity and type of signals delivered during cell expansion and manufacturing, resulting in the generation of more potent T‑cell products with desirable phenotypic and functional properties.

Figure 5: Nonclinical data demonstrate that CAR T cells enhanced with four technologies (c-Jun overexpression, NR4A3 knockout and manufactured with Epi-R and Stim-R) mediated anti-tumor response and enhanced survival in a murine xenograft tumor model, even at a very low CAR T‑cell dose of 100,000 CAR T cells. Additionally, both in vitro and in vivo nonclinical data demonstrated that the combination of all four of these technologies resulted in superior cytotoxicity, improved proliferation and sustained cytokine production upon repeated antigen stimulation compared to various controls lacking one or more of the reprogramming technologies.

Undisclosed New Technologies

~~Recently,~~In ~~alternative~~the ~~approaches~~solid ~~that~~tumor ~~arm~~setting, CAR- T cells ~~with~~need ~~TGF-β~~to ~~blockade~~overcome orthe ~~constitutive~~suppressive ~~cytokine~~tumor ~~signaling~~microenvironment to ~~enhance~~optimally ~~their~~kill ~~anti-tumor~~cancer ~~functionality~~cells. inWe ~~the~~believe ~~suppressive~~two ~~tumor~~key ~~microenvironment~~approaches ~~have~~to ~~shown~~achieve ~~promise~~this inare ~~the~~to ~~solid~~provide ~~tumor~~resistance ~~settings.~~to Ininhibitory ~~addition~~signals such as TGF–β, and to ~~developing~~enable ~~novel~~locally-released ~~CAR~~supportive ~~constructs~~cytokine ~~that~~signaling ~~target~~to ~~undisclosed~~enhance ~~tumor~~the ~~antigen~~antitumor ~~targets,~~functionality ~~our~~of the CAR T cells. Our nonclinical research activities explore stacking our proprietary anti-exhaustion ~~technology~~technologies ~~and~~with these additional approaches ~~targeting the tumor microenvironment~~ via the expression of novel chimeric proteins orand ~~polypeptides~~vector ~~(Table~~design 3) to ~~optimize~~generate ~~more~~fully-armed ~~durable~~ CAR T-cell ~~killing for application in future solid tumor~~ product candidates.

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Our Manufacturing Capabilities

We believe it is critically important to control and continuously monitor all aspects of the cell therapy manufacturing process to mitigate risks, including challenges in managing production, supply chain, patient ~~specimen~~material chain of custody and quality control. As we developed our technologies, we made a strategic decision to invest in building our own manufacturing facility to control our supply chain, maximize efficiencies in cell product production time, optimize cost and quality, protect proprietary aspects of our reprogramming technologies, and have the ability to rapidly incorporate advancements and new innovations. We view our manufacturing team and capabilities as a significant competitive advantage.

Our LyFE Manufacturing Center™ located in Bothell, Washington is approximately 73,000 square feet and is comprised of manufacturing suites, laboratories and offices. LyFE is manufacturing ronde-cel for the pivotal PiNACLE and PiNACLE-H2H trials and the ongoing Phase 1/2 clinical trial for patients with R/R LBCL and, upon successful transition of manufacturing from ICT, is expected to manufacture LYL273 for the ongoing U.S. Phase 1 clinical trial for patients with advanced mCRC. At full staffing and capacity, we expect to be able to manufacture >more than 1,~~000~~200 patient CAR T‑cell products/year, ~~able~~and to support our clinical development needs for ~~IMPT~~ronde-~~314~~cel, LYL273 and other pipeline programs, as well as early commercial launch ifof ~~IMPT~~ronde-~~314~~cel isand LYL273, if approved. LyFE was commissioned and designed to be in compliance with U.S. and European Union (EU) current Good Manufacturing Practices (cGMP) standards and has a flexible and modular design enabling ~~CAR~~ T~~‑cell, TIL, TCR T~~-cell therapies and cGMP viral vector production to control and de-risk the manufacturing sequence and timing of the major components of our supply chain. Owning our own facility has enabled seamless collaboration across research, process development and manufacturing for high-quality reproducibility at manufacturing scale.

Clinical supply for our Phase 1/2 trial of IMPT-314 is currently manufactured in our manufacturing facility in Los Angeles, California, that we acquired in connection with the acquisition of ImmPACT. As we accelerate development of IMPT-314, we are supplementing our Los Angeles manufacturing capacity through a manufacturing technology transfer to LyFE. We are focused on maintaining a manufacturing strategy that is operationally efficient to maximize our capacity and avoid any disruption to clinical trial supply.

Competition

The pharmaceutical industry is highly competitive and dynamic, owing to rapidly advancing technologies. We face potential competition from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions, government agencies and public and private research institutions. Any product candidates that we successfully develop and commercialize will compete with existing treatments and new treatments that may become available in the future. In addition, during development and clinical trials, our product candidates may compete against other experimental treatments, whether cell therapy or other modalities, for patients with certain histologies or patients with tumors expressing certain antigen targets of interest.

If approved, our product IMPT-314 will need to compete against other products approved in the 2nd and 3rd line+ settings in our approved indications, including any approved CD19 CAR T‑cell therapies, monoclonal antibodies targeting CD19, antibody-drug conjugates, selective inhibitors of exportin 1 and bispecific antibodies. 21

WeTable ~~are also aware~~ of a number of companies using autologous or allogeneic CAR T-cell therapy approaches to treat hematologic malignancies and solid tumors. Some of these companies have substantially greater financial and other resources than we have, such as larger research and development staff and well-established marketing and sales forces, or operate in jurisdictions where we do not have staffing or resources.Contents

~~CAR~~candidates ~~T‑cell~~may ~~therapies~~compete ~~for~~against ~~the~~other ~~treatment~~experimental ~~of hematologic malignancies and solid tumors are being developed by a number of companies~~treatments, ~~including~~whether ~~but~~cell ~~not~~therapy ~~limited~~or to Arcellx, Inc., Allogene Therapeutics, Inc., Arsenal Biosciences, Inc., AstraZeneca plc, Autolus Therapeutics plc, Bristol Myers Squibb Co., Caribou Biosciences, Inc., Cargo Therapeutics, Inc., Gilead Sciences Inc., Immunocore Holdings plc, Johnson & Johnson, Nanjing Legend Biotech, Novartis AG and Poseida/F. Hoffmann-La Roche AG . We are also aware that other ~~companies are developing therapies in~~ modalities, ~~such~~for aspatients ~~bispecific~~with ~~antibodies~~certain ~~for~~histologies ~~B-cell~~or ~~lymphomas,~~patients ~~including~~with ~~AstraZeneca,~~tumors F.expressing ~~Hoffmann-La~~certain ~~Roche~~antigen AGtargets ~~and~~of ~~Amgen Inc~~interest.

~~Among~~If ~~companies~~approved, ~~developing CAR T~~ronde-~~cell~~cel ~~therapies~~will ~~for~~need ~~hematologic~~to ~~malignancies~~compete ~~and~~against ~~solid~~other ~~tumors,~~products weapproved ~~believe~~in wethe ~~are~~2L ~~substantially~~and ~~differentiated~~3L+ bysettings in our ~~technologies~~approved indications, ~~manufacturing~~including ~~protocols~~approved ~~and~~CD19 ~~capabilities,~~CAR ~~knowledge,~~T‑cell ~~experience~~therapies, ~~scientific~~monoclonal ~~personnel~~antibodies ~~and~~targeting ~~robust intellectual property portfolio. We believe there are many factors affecting the success of any of our product candidates~~CD19, ~~including~~antibody‑drug ~~efficacy~~conjugates, ~~safety,~~bispecific ~~accessibility,~~antibodies ~~price~~ and ~~scale~~selective ~~and~~inhibitors ~~cost~~ of ~~manufacturing~~exportin 1.

If approved, LYL273 will need to compete against other products approved in the 3L+ setting in our approved indications such as mCRC, including any approved kinase inhibitors, antibody-drug conjugates, cytotoxic chemotherapies and immunotherapies.

We are also aware of a number of companies using autologous or allogeneic CAR T-cell therapy approaches to treat hematologic malignancies and solid tumors.

Some of the companies developing competitive products have substantially greater financial and other resources than we have, such as larger research and development staff and well-established marketing and sales forces, or operate in jurisdictions where we do not have staffing or resources.

CAR T‑cell therapies for the treatment of hematologic malignancies and solid tumors are being developed by a number of companies, including but not limited to Agenus Inc., Akeso, Inc., Arcellx, Inc., Allogene Therapeutics, Inc., Arsenal Biosciences, Inc., AstraZeneca plc, Autolus Therapeutics plc, Bristol Myers Squibb Co., Caribou Biosciences, Inc., Gilead Sciences Inc., Immunocore Holdings plc, Johnson & Johnson, Nanjing Legend Biotech, Novartis AG, Pfizer Inc., Poseida/F. Hoffmann-La Roche AG and Summit Therapeutics Inc. We are also aware that other companies are developing therapies in modalities such as bispecific antibodies for B-cell lymphomas, including AstraZeneca, F. Hoffmann-La Roche AG and Amgen Inc. New treatments for colorectal cancer that may change the therapeutic landscape, including bispecific antibodies like PD-1/VEGF or PD-1/CTLA-4 bispecifics, are being developed by companies such as Summit Therapeutics, AbbVie, Akeso, Agenus, and Pfizer. CytomX has moved beyond dose escalation in a Phase 1 trial for a novel masked, conditionally activated antibody-drug conjugate directed against epithelial cell adhesion molecule under evaluation in patients with colorectal cancer.

Among companies developing CAR T-cell therapies for hematologic malignancies and solid tumors, we believe we are substantially differentiated by our technologies, manufacturing protocols, capabilities, knowledge, experience, scientific personnel and robust intellectual property portfolio. We believe there are many factors affecting the success of any of our product candidates, including efficacy, safety, accessibility, price and scale and cost of manufacturing.

License and Collaboration Agreements

UCLA License Agreement

As a result of our October 2024 acquisition of ImmPACT, we ~~assumed~~acquired ~~its~~ rights and assumed obligations under a license agreement with the Regents of the University of California, acting through The Technology Development Group of UCLA, dated February 18, 2021, as amended (the UCLA License Agreement). Pursuant to the UCLA License Agreement, UCLA granted us (i) an exclusive, royalty‑bearing license, with the right to sublicense through a specified number of tiers, under certain patent rights owned by UCLA and certain patent rights co‑owned by UCLA and the Seattle Children’s Hospital doing business as the Seattle Children’s Research Institute (SCRI) and (ii) a non‑exclusive, royalty‑bearing license, with the right to sublicense through a specified number of tiers, under related technical information, in each case related to our CD19/CD20 program, for the development, use and sale of products or services associated with certain inventions made in the course of research by UCLA and SCRI in all fields of use. In accordance with the Patent and Trademark Law Amendments Act (the Bayh‑Dole Act), UCLA granted the U.S. federal government a non‑exclusive, non‑transferable, irrevocable, paid‑up license to the licensed patents.

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exclusive, royalty‑bearing license, with the right to sublicense through a specified number of tiers, under certain patent rights owned by UCLA and certain patent rights co‑owned by UCLA and the Seattle Children’s Hospital doing business as the Seattle Children’s Research Institute (SCRI) and a non‑exclusive, royalty‑bearing license, with the right to sublicense through a specified number of tiers, under related technical information, in each case related to our CD19/CD20 program, for the development, use and sale of products or services associated with certain inventions made in the course of research by UCLA and SCRI in all fields of use. In accordance with the Patent and Trademark Law Amendments Act (the Bayh‑Dole Act), UCLA granted the U.S. federal government a non‑exclusive, non‑transferable, irrevocable, paid‑up license to the licensed patents.

Under the UCLA License Agreement, we are obligated to diligently develop and commercialize licensed products and to achieve certain development, regulatory and commercialization diligence milestones. If, subject to our right to extend such diligence milestones in certain circumstances, we are unable to meet our diligence obligations and do not agree with UCLA to modify such obligations, UCLA has the right and option to either terminate the license agreement or convert the granted rights to a non‑exclusive license. We are also required, subject to certain exceptions, to provide UCLA with an affordable access plan within a specified time following the first commercial sale of a licensed product that is intended to support affordable access to licensed products in certain low‑ and middle‑income countries and other countries in which we do not intend to commercialize licensed products.

UCLA and SCRI reserved, for themselves and for other nonprofit and academic research institutions, their rights to use the patent rights and technical information licensed to us for education and research purposes and to publish results arising therefrom, and for UCLA to offer and perform clinical diagnostic and prognostic services for patients in the ~~University of California healthcare system, in each case subject to certain exclusions. Our rights under the UCLA License Agreement are also subject to certain government rights.~~

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University of California healthcare system, in each case subject to certain exclusions. Our rights under the UCLA License Agreement are also subject to certain government rights.

Under the UCLA License Agreement, ImmPACT paid UCLA a small upfront license issue fee and, upon our assumption of the agreement in connection with our acquisition of ImmPACT, we are obligated to pay a nominal, tiered annual license maintenance fee each year of the term until we make the first commercial sale of a licensed product. Upon the achievement of specified development, regulatory and commercial milestones, we are obligated to pay UCLA one-time milestone payments of up to an aggregate amount in the mid-single digit millions for each commercialized licensed product. In addition, we are obligated to pay UCLA a tiered royalty on worldwide annual net sales of any commercialized licensed products in the low‑ to mid-single digits percentage, subject to specified and capped reductions and a tiered minimum annual royalty payment of between a low-five figure and a low-six figure amount. ImmPACT reimbursed UCLA for all patent costs incurred prior to the effective date of the UCLA License Agreement, and we are obligated to reimburse UCLA for all patent costs incurred by them during the term of the license agreement.

The ~~license~~UCLA ~~agreement~~License Agreement will expire, on a product-by-product and country-by-country basis, on the later of (a) the expiration of the last to expire valid claim of the patent rights covering such product in such country and (b) ten (10) years after the date of the first commercial sale of such product in such country. UCLA has the right to terminate the agreement in the event of our uncured material breach, subject to a specified notice and cure period, or upon certain insolvency events. We may terminate the agreement for convenience, subject to a specified notice period.

ICT License Agreement

On November 6, 2025, we entered into an Exclusive License Agreement with ICT for the development and commercialization of LYL273, a novel GCC-targeted CAR T-cell product candidate for the treatment of mCRC and other GCC-expressing cancers (the ICT License Agreement). Pursuant to the terms of the ICT License Agreement, we received exclusive global rights, outside of mainland China, Hong Kong, Macau and Taiwan, to research, develop, manufacture, commercialize and otherwise exploit certain product candidates and products, including LYL273, worldwide in exchange for an upfront payment of $40 million in cash and the issuance of 1.9 million shares of our common stock. In addition, ICT is eligible to receive additional cash and equity payments of (i) a potential $30 million clinical milestone payment, up to $115 million upon the achievement of certain late-stage regulatory milestones and up to $675 million in commercial sales milestones; (ii) up to an additional 1.85 million shares of our common stock based on the achievement of certain clinical and regulatory milestones; and (iii) tiered royalties ranging from mid-single-digits up to 10% on annual net sales in the United States and low- to mid-single-digit royalties on annual net sales in other countries within the licensed territory.

The ICT License Agreement includes customary representations, warranties and covenants, including, but not limited to, covenants by us and ICT to conduct the research, development, manufacture, commercialization and other exploitation of the product candidates and products, and their other obligations under the ICT License Agreement, in compliance with the terms of the ICT License Agreement and all other applicable laws and marketing approvals.

The ICT License Agreement may be terminated, among other circumstances, (i) by either party for uncured material breach, (ii) by either party due to the insolvency of the other party, (iii) by us for safety or regulatory reasons or (iv) by us on a product-by-product and country-by-country basis in our sole discretion after providing certain notice.

The ICT License Agreement (and any right or obligation thereunder) may not be assigned without the prior written consent of the other party, except to an affiliate or third party that acquires the business of the assigning party by way of a merger or sale of assets.

Intellectual Property

We strive to protect and enhance the proprietary technology, inventions and improvements that are commercially important to our business, including seeking, maintaining and defending patent rights, whether developed internally or licensed from our collaborators or other third parties. ~~Our~~We ~~policy is to~~ seek to protect our proprietary position by, among other methods, filing patent applications in the United States and in jurisdictions outside of the United States related to our proprietary technology, inventions, improvements and product candidates that are important to the development and implementation of our business. We also rely on trade secrets and know-how relating to our proprietary technology and product candidates, continuing innovation and in-licensing opportunities to develop, strengthen and maintain our proprietary position in the field of cell and gene therapy. We additionally plan to rely on data exclusivity, market exclusivity and patent‑term extensions, when available, and, as appropriate, have sought and in the future may seek again and rely on regulatory protection afforded through Orphan Drug designations. Our commercial success may depend in part on our ability to obtain and maintain patent and other proprietary protection for our technology, inventions and improvements; to preserve the confidentiality of our trade secrets; to maintain our licenses to use intellectual property owned by third parties; to defend and enforce our proprietary rights, including our patents; and to operate without infringing on the valid and enforceable patents and other proprietary rights of third parties.

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We have in-licensed and procured, and filed for numerous patent applications, which include claims directed to compositions, methods of use, processes, dosing and formulations, and possess substantial know-how and trade secrets relating to the development and commercialization of our cell engineering technology platforms and related product candidates, including related manufacturing processes and protocols. Our intellectual property strategy is designed to provide multi-layered protection covering our ~~technologies~~product ~~and manufacturing protocols~~candidates, including ~~but~~ronde-cel, ~~not~~LYL273 ~~limited~~and toour cnext-~~Jun,~~generation ~~NR4A3,~~solid ~~CD62L+~~tumor ~~enrichment~~programs, ~~Epi‑R and Stim‑R,~~ as well as our various ~~aspects~~platform oftechnologies ~~our~~and ~~product~~manufacturing ~~candidates~~protocols, including but not limited to ~~CAR~~c‑Jun, ~~constructs~~NR4A3, CD62L-positive cell enrichment, tumor restricted IL-12 variants and Epi‑R. For all patent applications, we determine claiming strategy on a case-by-case basis. We may file patent applications containing claims for protection of all useful applications of our proprietary technology platforms and any products, as well as new applications and/or uses we discover for existing technology platforms and products. We continuously reassess the number and type of patent applications, as well as the pending and issued patent claims, to ensure that maximum coverage and value are obtained for our processes and compositions. Further, claims may be modified during patent prosecution to meet our intellectual property and business needs. Notwithstanding these efforts, we cannot be sure that any patents will be granted with respect to any patent application we have licensed or filed or may license or file in the future, and we cannot be sure that any patents we have licensed or patents that may be licensed or granted to us in the future will not be challenged, invalidated or circumvented or that such patents will be commercially useful in protecting our technologies.

As of December 31, ~~2024~~2025, our patent portfolio consists of ~~over~~at 50least 45 issued patents and ~~over~~150 ~~250~~ pending patent applications that we either own or have licensed. Our portfolio covers our product candidates, including ronde-cel, LYL273 and our next-generation solid tumor programs, as well as various aspects of our technologies and manufacturing protocols, including but not limited to c-Jun, NR4A3, CD62L+-positive cell enrichment, ~~Epi‑R~~tumor ~~and~~restricted ~~Stim‑R,~~IL-12 asvariants ~~well~~and ~~as our product candidates~~Epi‑R. The patents and patent applications in our portfolio are held primarily in the United States, Europe, Canada, Japan and Australia. For information related to our in-licensed intellectual property, see the subsection titled under “—License and Collaboration Agreements.”

Individual patents extend for varying periods of time, depending upon the date of filing of the patent application, the date of patent issuance and the legal term of patents in the countries in which they are obtained. Generally, patents issued for applications filed in the United States are effective for 20 years from the earliest nonprovisional filing date. In the United States, a patent’s term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the U.S. Patent and Trademark Office (USPTO) in examining and granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier filed patent. In addition, in certain instances, the patent term of a U.S. patent that covers an FDA‑approved drug may also be eligible for extension to recapture a portion of the term effectively lost as a result of clinical trials and the FDA regulatory review period,. ~~such~~Such an extension is referred to as patent term extension. The restoration period cannot be longer than five years and the total patent term, including the restoration period, must not exceed 14 years following FDA approval. Similar provisions are available in Europe and certain other foreign jurisdictions to extend the term of a patent that covers an approved drug. However, there is no guarantee that the applicable authorities, including the FDA in the United States, will agree with our assessment of whether such extensions should be granted, and if granted, the length of such extensions. The duration of patents outside of the United States varies in accordance with provisions of applicable local law, but typically is also 20 years from the earliest nonprovisional filing date. The actual protection afforded by a patent varies on a product-by-product basis, from country-to-country, and depends upon many factors, including the type of patent, the scope of its coverage, the availability of regulatory-related extensions, the availability of legal remedies in a particular country and the validity and enforceability of the patent.

As of December 31, 2024, our registered trademark portfolio contains over 135 registered trademarks and pending trademark applications, consisting of approximately one trademark registration and four pending trademark applications in the United States, and approximately 121 foreign trademark registrations and approximately 10 foreign pending trademark applications.

We may also rely, in some circumstances, on trade secrets to protect our technology. However, trade secrets are difficult to protect. We seek to protect our technology and product candidates, in part, by entering into confidentiality agreements with those who have access to our confidential information, including our employees, contractors, consultants, collaborators and advisors. We also seek to preserve the integrity and confidentiality of our proprietary technology and processes by maintaining physical security of our premises and physical and electronic security of our information technology systems. Although we have confidence in these individuals, organizations and systems, agreements or security measures may be breached and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or may be independently discovered by competitors. To the extent that our employees, contractors, consultants, collaborators and advisors use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions. For this and more comprehensive risks related to our proprietary technology, inventions, improvements and product candidates, see the subsection titled “Risk Factors —Risks Relating to Our Intellectual Property.”

Sales and Marketing

Given our stage of development, we have not yet established a commercial organization or distribution capabilities. We intend to either build a commercial infrastructure to support sales of any approved products or outsource some or all of this function to third parties. We intend to evaluate opportunities to work with partners that enhance our

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~~some or all of this function to third parties. We intend to evaluate opportunities to work with partners that enhance our~~ capabilities with respect to the development and commercialization of ~~IMPT~~ronde-~~314~~cel, LYL273, and any other product candidates we may develop. In addition, we intend to commercialize our product candidates, if approved, in key markets either alone or with partners to maximize the worldwide commercial potential of our programs for ronde‑cel and LYL273.

Government Regulation

The FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of biologics such as those we are developing. We, along with our third-party contractors, will be required to navigate the various nonclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct trials or seek approval or licensure of our product candidates. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.

U.S. Biologics Regulation

In the United States, biological products are subject to regulation under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act and other federal, state, local and foreign statutes and regulations. The process required by the FDA before biologics may be marketed in the United States generally involves the following:

•completion of nonclinical laboratory tests and animal studies performed in accordance with the FDA’s Good Laboratory Practice requirements (GLP);

•submission to the FDA of an IND application, which must become effective before human clinical trials may begin;

•approval by an Institutional Review Board (IRB) or ethics committee at each clinical site before the trial is commenced;

•performance of adequate and well-controlled human clinical trials according to the FDA’s regulations (commonly referred to as ~~GCP~~GCPs), ~~regulations~~ and any additional requirements for the protection of human research subjects and their health information to establish the safety, purity and potency of the proposed biologic product candidate for its intended purpose;

•preparation of and submission to the FDA of a Biologics License Application (BLA), after completion of all pivotal clinical trials;

•a determination by the FDA within 60 days of its receipt of a BLA to file the application for review;

•satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMP and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency and, if applicable, to assess compliance with the FDA’s current Good Tissue Practices (cGTPs) requirements for the use of human cellular and tissue products, and of selected clinical investigation sites to assess compliance with GCPs;

•satisfactory completion of an FDA Advisory Committee review, if applicable;

•potential FDA audit of the nonclinical and clinical trial sites that generated the data in support of the BLA; and

•FDA review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the United States.

~~Before~~An ~~testing~~IND ~~any~~automatically ~~biological~~becomes ~~product~~effective ~~candidate~~30 indays ~~humans~~after receipt by the FDA, unless the ~~product~~FDA, ~~candidate~~within ~~enters~~the 30-day time period, raises safety concerns or questions about the ~~nonclinical~~proposed ~~testing~~clinical ~~stage~~trial. ~~Nonclinical~~In ~~tests,~~such ~~also~~a ~~referred~~case, tothe asIND ~~preclinical~~may ~~studies,~~be ~~include~~placed ~~laboratory~~on ~~evaluations~~clinical ofhold ~~product~~and ~~chemistry,~~the ~~toxicity~~IND sponsor and ~~formulation,~~the asFDA ~~well~~must asresolve ~~animal~~any ~~studies~~outstanding toconcerns ~~assess~~or questions before the ~~potential~~clinical ~~safety~~trial ~~and~~can ~~activity~~begin. Submission of ~~the~~an ~~product~~IND, ~~candidate~~therefore, may or may not result in FDA authorization to begin a clinical trial. ~~The~~A ~~conduct~~clinical ofhold can additionally be imposed by the ~~nonclinical~~FDA ~~tests~~at ~~must~~any ~~comply~~time ~~with~~during ~~federal~~the ~~regulations~~conduct ~~and~~of ~~requirements~~a ~~including~~clinical ~~GLPs~~trial under an IND.

~~Prior~~In addition to ~~beginning~~the submission of an IND to the ~~first~~FDA ~~clinical~~before ~~trial~~initiation ~~with~~of a ~~product~~clinical ~~candidate~~trial in the United States, wecertain ~~must~~human ~~submit~~clinical antrials ~~IND~~involving torecombinant ~~the~~or ~~FDA.~~synthetic Annucleic ~~IND~~acid ismolecules aare ~~request~~subject ~~for~~to ~~authorization~~oversight ~~from~~of ~~the~~an ~~FDA~~Institutional toBiosafety ~~administer~~Committee an(IBC) ~~investigational~~as ~~new~~set ~~drug~~forth toin ~~humans.~~the ~~The~~National ~~central~~Institutes ~~focus~~ of anHealth ~~IND~~(NIH) ~~submission~~Guidelines isfor onResearch ~~the~~Involving ~~general~~Recombinant ~~investigational~~DNA ~~plan~~Molecules ~~and~~ (the ~~protocol(s)~~NIH ~~for clinical trials~~Guidelines). ~~The~~Specifically, ~~IND~~under ~~also~~the ~~includes~~NIH ~~results~~Guidelines, supervision of ~~animal~~human ~~and in~~gene ~~vitro studies~~transfer ~~assessing~~trials ~~the~~includes ~~toxicology,~~evaluation ~~pharmacokinetics, pharmacology~~ and ~~pharmacodynamic~~assessment ~~characteristics~~by ofan ~~the~~IBC, ~~product;~~a ~~chemistry,~~local ~~manufacturing~~institutional ~~and~~committee ~~controls~~that ~~information;~~reviews and ~~any~~oversees ~~available~~research ~~human~~utilizing ~~data~~recombinant or ~~literature~~synthetic tonucleic ~~support~~acid ~~the~~molecules ~~use~~at ofthat ~~the investigational product~~institution. AnThe ~~IND~~IBC ~~must~~assesses ~~become~~the ~~effective~~safety ~~before~~of ~~human~~the

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~~clinical~~research ~~trials~~and ~~may~~identifies ~~begin.~~any ~~The~~potential ~~IND~~risk ~~automatically~~to ~~becomes~~public ~~effective~~health ~~30 days~~or ~~after receipt by~~ the ~~FDA~~environment, ~~unless~~and ~~the~~such ~~FDA,~~review ~~within~~may ~~the~~result ~~30-day~~in ~~time~~some ~~period,~~delay ~~raises~~before ~~safety~~initiation ~~concerns~~of ora ~~questions about the proposed~~ clinical trial. InWhile ~~such a case,~~ the ~~IND~~NIH ~~may~~Guidelines beare ~~placed~~not onmandatory ~~clinical~~unless ~~hold and~~ the ~~IND~~research ~~sponsor~~in ~~and~~question ~~the~~is ~~FDA~~being ~~must~~conducted ~~resolve~~at ~~any~~or ~~outstanding~~sponsored ~~concerns~~by orinstitutions ~~questions~~receiving ~~before~~NIH ~~the~~funding ~~clinical~~of ~~trial~~recombinant ~~can~~or ~~begin.~~synthetic ~~Submission~~nucleic ofacid anmolecule ~~IND~~research, ~~therefore~~many ~~may~~companies orand ~~may~~other institutions not ~~result~~otherwise insubject ~~FDA~~to ~~authorization~~the toNIH ~~begin~~Guidelines avoluntarily ~~clinical~~follow ~~trial~~them.

InClinical ~~addition~~trials toinvolve the ~~submission~~administration of anthe ~~IND~~investigational product to ~~the~~human ~~FDA~~subjects ~~before~~under ~~initiation~~the supervision of aqualified ~~clinical~~investigators ~~trial~~ in ~~the~~accordance ~~United~~with ~~States~~GCPs, ~~certain~~which ~~human~~include ~~clinical~~the ~~trials~~requirement ~~involving~~that ~~recombinant~~all orresearch ~~synthetic~~subjects ~~nucleic~~provide ~~acid~~their ~~molecules~~informed ~~are~~consent ~~subject~~for totheir ~~oversight~~participation ofin anany ~~Institutional~~clinical ~~Biosafety~~trial. ~~Committee~~Clinical ~~(IBC)~~trials asare ~~set~~conducted ~~forth~~under inprotocols ~~the~~detailing, ~~National~~among ~~Institutes~~other things, the objectives of ~~Health~~the ~~(NIH)~~trial, ~~Guidelines~~the ~~for~~parameters ~~Research~~to ~~Involving~~be ~~Recombinant~~used ~~DNA~~in ~~Molecules~~monitoring (safety and the ~~NIH~~effectiveness ~~Guidelines)~~criteria to be evaluated. ~~Specifically,~~A ~~under~~separate submission to the ~~NIH~~existing ~~Guidelines,~~IND ~~supervision~~must ofbe ~~human~~made ~~gene~~for ~~transfer~~each ~~trials~~successive ~~includes~~clinical ~~evaluation~~trial conducted during product development and ~~assessment~~for byany ansubsequent ~~IBC~~protocol amendments. Furthermore, aan ~~local~~IRB ~~institutional~~for ~~committee~~each ~~that~~site ~~reviews~~proposing to conduct the clinical trial must review and ~~oversees~~approve ~~research~~the ~~utilizing~~plan ~~recombinant~~for orany ~~synthetic~~clinical ~~nucleic~~trial ~~acid~~and ~~molecules~~its informed consent form before the clinical trial begins at that ~~institution.~~site, ~~The~~and ~~IBC~~must ~~assesses~~monitor the ~~safety~~trial ofuntil completed. Regulatory authorities, the ~~research~~IRB ~~and~~or ~~identifies~~the sponsor may suspend a clinical trial at any ~~potential~~time ~~risk~~on various grounds, including a finding that the subjects are being exposed to ~~public~~an unacceptable health risk or that the ~~environment,~~trial ~~and~~is ~~such~~unlikely ~~review~~to ~~may~~meet ~~result~~its instated ~~some~~objectives. ~~delay~~Some ~~before~~trials ~~initiation~~also include oversight by an independent group of aqualified experts organized by the clinical trial. ~~While~~sponsor, ~~the~~known ~~NIH~~as ~~Guidelines~~a ~~are~~Data Safety Monitoring Committee, which provides authorization for whether or not ~~mandatory~~a ~~unless~~trial may move forward at designated checkpoints based on access to certain data from the ~~research~~trial inand ~~question~~may ishalt ~~being~~the ~~conducted~~clinical attrial orif ~~sponsored~~it bydetermines ~~institutions~~that ~~receiving~~there ~~NIH~~is ~~funding~~an ofunacceptable ~~recombinant~~safety orrisk ~~synthetic~~for ~~nucleic~~subjects ~~acid~~or ~~molecule~~other ~~research~~grounds, ~~many~~such ~~companies~~as ~~and~~no ~~other~~demonstration ~~institutions~~of ~~not~~efficacy. ~~otherwise~~There ~~subject~~are toalso requirements governing the ~~NIH~~reporting ~~Guidelines~~of ~~voluntarily~~ongoing ~~follow~~clinical ~~them~~trials and clinical trial results to public registries.

~~Clinical~~In ~~trials~~some ~~involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCPs~~cases, ~~which include~~ the ~~requirement~~FDA ~~that~~may ~~all research subjects provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing~~require, ~~among~~or ~~other~~companies ~~things,~~may ~~the~~voluntarily ~~objectives of the study~~pursue, ~~the~~additional ~~parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive~~ clinical ~~trial~~trials ~~conducted~~after ~~during~~a product ~~development~~is ~~and~~approved ~~for any subsequent protocol amendments. Furthermore, an IRB for each site proposing~~ to ~~conduct~~gain ~~the~~more ~~clinical~~information ~~trial~~about ~~must review and approve~~ the ~~plan~~product ~~for~~in ~~any clinical trial and its informed consent form before~~ the ~~clinical~~intended ~~trial~~therapeutic ~~begins at that site~~indication, ~~and~~particularly ~~must~~for ~~monitor~~long‑term ~~the~~safety ~~study until completed~~follow-up. ~~Regulatory~~These ~~authorities,~~so-called ~~the~~Phase ~~IRB~~4 ortrials ~~the sponsor~~ may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also ~~include~~be ~~oversight~~made ~~by an independent group of qualified experts organized by the clinical trial sponsor, known as~~ a ~~Data~~condition ~~Safety Monitoring Committee, which provides authorization for whether or not a study may move forward at designated check points based on access~~ to ~~certain~~approval ~~data from the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds, such as no demonstration~~ of ~~efficacy. There are also requirements governing~~ the ~~reporting of ongoing clinical trials and clinical trial results to public registries~~BLA.

For purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

•Phase 1—The investigational product is initially introduced into healthy human subjects or patients with the target disease or condition. These trials are designed to test the safety, dosage tolerance, absorption, metabolism and excretion of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

•Phase 2—The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.

•Phase 3—The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.

In some cases, the FDA may require, or companies may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the product in the intended therapeutic indication, particularly for long-term safety follow-up. These so-called Phase 4 trials may also be made a condition to approval of the BLA.

Concurrent with clinical trials, companies may complete additional animal studies and develop additional information about the biological characteristics of the product candidate and must finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, must develop methods for testing the identity, strength, quality and purity of the final product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

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BLA Submission and Review by the FDA

Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications. The BLA must include all relevant data available from nonclinical and clinical trials, including negative or ambiguous results, as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls and proposed labeling, among other things. Data can come from company-sponsored clinical trials intended to test the safety and effectiveness of a use of the product, or from a number of alternative sources, including trials initiated by independent investigators. The submission of a BLA requires payment of a substantial application user fee to the FDA, unless a waiver or exemption applies.

Within 60 days following submission of the application, the FDA reviews a BLA to determine if it is substantially complete before the FDA accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In this event, the BLA must be resubmitted with the additional information. Once a BLA has been accepted for filing, the FDA’s goal is to review standard applications within 10 months after the filing date, or, if the application qualifies for priority review, six months after the FDA accepts the application for filing. In both standard and priority reviews, the review process may also be extended by FDA requests for additional information or clarification. The FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent, and the facility in which it is manufactured, processed, packed or held meets standards designed to assure the product’s continued safety, purity and potency. The FDA may also convene an advisory committee to provide clinical insight on application review questions. The FDA is not bound by the recommendations of an advisory committee, but it ~~considers~~may consider such recommendations carefully when making decisions.

Before approving a BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP and adequate to assure consistent production of the product within required specifications. For a product candidate that is also a human cellular or tissue product, the FDA also will not approve the application if the manufacturer is not in compliance with cGTPs. These are FDA regulations that govern the methods used in, and the facilities and controls used for, the manufacture of human cells, tissues and cellular and tissue-based products (HCT/Ps), which are human cells or tissue intended for implantation, transplant, infusion or transfer into a human recipient. The primary intent of the GTP requirements is to ensure that cell and tissue-based products are manufactured in a manner designed to prevent the introduction, transmission and spread of communicable disease. FDA regulations also require tissue establishments to register and list their HCT/Ps with the FDA and, when applicable, to evaluate donors through screening and testing. Additionally, before approving a BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. If the FDA determines that the application, manufacturing process or manufacturing facilities, or data collected from clinical trial sites are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

After the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response Letter (CRL). An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A CRL will describe all of the deficiencies that the FDA has identified in the BLA, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may issue the CRL without first conducting required inspections, testing submitted product lots and/or reviewing proposed labeling. In issuing the CRL, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional information or clarification. The FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product.26

If regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the indicated uses for which such product may be marketed. For example, the FDA may approve the BLA with a Risk Evaluation and Mitigation Strategy (REMS), to ensure the benefits of the product outweigh its risks, or otherwise limit the scope of any approval. A REMS is a safety strategy implemented to manage a known or potential serious risk associated with a product and to enable patients to have continued access to such medicines by managing their safe use, and could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace. The FDA may require one or more Phase 4

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~~post-marketing~~which ~~trials~~are human cells or tissue intended for implantation, transplant, infusion or transfer into a human recipient. The primary intent of the GTP requirements is to ensure that cell and ~~surveillance~~tissue-based products are manufactured in a manner designed to ~~further~~prevent ~~assess~~the introduction, transmission and ~~monitor~~spread of communicable disease. FDA regulations also require tissue establishments to register and list their HCT/Ps with the ~~product’s~~FDA ~~safety~~and, when applicable, to evaluate donors through screening and ~~effectiveness~~testing. ~~after~~Additionally, ~~commercialization~~before approving a BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. If the FDA determines that the application, manufacturing process or manufacturing facilities, or data collected from clinical trial sites are not acceptable, it will outline the deficiencies in the submission and ~~may~~often ~~limit~~will ~~further~~request ~~marketing~~additional testing or information. Notwithstanding the submission of any requested additional information, the ~~product~~FDA ~~based~~ultimately onmay decide that the ~~results~~application ofdoes ~~these~~not ~~post-marketing~~satisfy ~~studies~~the regulatory criteria for approval.

After the FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response Letter (CRL). An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A CRL describes all of the deficiencies that the FDA has identified in the BLA, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may issue the CRL without first conducting required inspections, testing submitted product lots and/or reviewing proposed labeling. In issuing the CRL, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional information or clarification. The FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor the safety or efficacy of a product.

Expedited Development and Review Programs

The FDA offers a number of expedited development and review programs for qualifying product candidates. For example, the Fast Track program is intended to expedite or facilitate the process for reviewing new products that are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. Specifically, new biological products are eligible for Fast Track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. Fast Track designation applies to the combination of the product and the specific indication for which it is being studied. The sponsor of a new biologic may request that the FDA designate the biologic as a Fast Track product at any time during the clinical development of the product. The sponsor of a Fast Track product has opportunities for more frequent interactions with the applicable FDA review team during product development and, once a BLA is submitted, the product candidate may be eligible for priority review. A Fast Track product may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.

A product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for Breakthrough Therapy Designation to expedite its development and review. A product candidate can receive Breakthrough Therapy Designation if preliminary clinical evidence indicates that the product candidate, alone or in combination with one or more other drugs or biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The designation includes all of the Fast Track program features, as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite the development and review of the product candidate, including involvement of senior managers.

Any marketing application for a drug or biologic submitted to the FDA for approval, including a product candidate with Fast Track and/or Breakthrough Therapy Designation, may be eligible for other types of FDA programs intended to expedite development and review, such as Priority Review and Accelerated Approval. A product candidate is eligible for Priority Review if it has the potential to provide safe and effective therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment, diagnosis or prevention of a disease compared to marketed products. The FDA will attempt to direct additional resources to the evaluation of an application for a new biological product designated for priority review in an effort to facilitate the review. For original BLAs, Priority Review designation means the FDA’s goal is to take action on the marketing application within six months of the 60-day filing date (as compared to 10 months under standard review).27

Additionally, product candidates studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive Accelerated Approval upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. As a condition of Accelerated Approval, the FDA will generally require the sponsor to perform adequate and well-controlled post-marketing clinical trials to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. Products receiving Accelerated Approval may be subject to expedited withdrawal procedures if the sponsor fails to conduct the required post-marketing studies or if such studies fail to verify the predicted clinical benefit. In addition, the FDA currently requires as a condition for Accelerated Approval pre-approval of promotional materials, which could adversely impact the timing of the commercial launch of the product.

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~~meaningful~~Any ~~number~~marketing ofapplication ~~clinical~~for ~~trial~~a ~~sites,~~drug ~~including~~or ~~through~~biologic ~~expansion~~submitted ~~of trials~~ to ~~additional~~the ~~sites.~~FDA ~~RMAT-designated~~for ~~products~~approval, ~~that~~including ~~receive~~a ~~Accelerated~~product ~~Approval~~candidate ~~may,~~with asFast ~~appropriate,~~Track ~~fulfill~~and/or ~~their~~Breakthrough ~~post-approval~~Therapy ~~requirements~~Designation, ~~through~~may ~~submission~~be ofeligible ~~clinical~~for ~~evidence,~~other ~~clinical~~types ~~trials,~~of ~~patient~~FDA ~~registries~~programs orintended ~~other~~to ~~sources~~expedite ofdevelopment ~~real-world~~and ~~evidence~~review, (such as ~~electronic~~Priority ~~health~~Review ~~records);~~and ~~through~~Accelerated ~~the~~Approval. ~~collection~~A ofproduct ~~larger~~candidate ~~confirmatory~~is ~~data~~eligible ~~sets;~~for orPriority ~~via~~Review ~~post-approval~~if ~~monitoring~~it ofhas ~~all~~the ~~patients~~potential ~~treated~~to ~~with~~provide ~~such~~safe ~~therapy~~and ~~prior~~effective totherapy ~~approval~~where ofno ~~such~~satisfactory alternative therapy. ~~Fast~~exists ~~Track,~~or ~~Breakthrough~~a ~~Therapy~~significant ~~Designation,~~improvement ~~Priority~~in ~~Review~~the treatment, ~~Accelerated~~diagnosis ~~Approval~~or ~~and~~prevention ~~RMAT~~of ~~designation~~a dodisease ~~not~~compared ~~change~~to ~~the~~marketed ~~standards~~products. ~~for~~The ~~approval~~FDA ~~but~~will ~~may~~attempt ~~expedite~~to ~~the~~direct ~~development~~additional orresources ~~approval~~to ~~process.~~the ~~Even~~evaluation ifof an application for a ~~product~~new ~~candidate~~biological ~~qualifies~~product designated for ~~one~~Priority orReview ~~more~~in ofan ~~these~~effort ~~programs,~~to facilitate the ~~FDA~~review. ~~may~~For ~~later~~original ~~decide~~BLAs, ~~that~~Priority Review designation means the ~~product~~FDA’s nogoal ~~longer~~is ~~meets~~to take action on the ~~conditions~~marketing ~~for~~application ~~qualification~~within orsix ~~decide~~months ~~that~~of the ~~time~~60-day ~~period~~filing ~~for~~date ~~FDA~~(as ~~review~~compared orto ~~approval~~10 ~~will~~months ~~not~~under bestandard ~~shortened~~review).

Regenerative Medicine Advanced Therapy (RMAT) designation is intended to facilitate an efficient development program for, and expedite review of, any drug or biologic that meets the following criteria: (i) the drug or biologic qualifies as a RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited exceptions; (ii) the drug or biologic is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition; and (iii) preliminary clinical evidence indicates that the drug or biologic has the potential to address unmet medical needs for such a disease or condition. RMAT designation provides all the benefits of Breakthrough Therapy Designation, including more frequent meetings with the FDA to discuss the development plan for the product candidate and eligibility for rolling review and Priority Review. Product candidates granted RMAT designation may also be eligible for Accelerated Approval on the basis of a surrogate or intermediate endpoint reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of clinical trial sites, including through expansion of trials to additional sites. RMAT-designated products that receive Accelerated Approval may, as appropriate, fulfill their post-approval requirements through submission of clinical evidence, clinical trials, patient registries or other sources of real-world evidence (such as electronic health records); through the collection of larger confirmatory data sets; or via post-approval monitoring of all patients treated with such therapy prior to approval of such therapy. Fast Track, Breakthrough Therapy Designation, Priority Review, Accelerated Approval and RMAT designation do not change the standards for approval but may expedite the development or approval process. Even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product candidate no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

Orphan Drug Designation and Exclusivity

Under the Orphan Drug Act, the FDA may grant Orphan Drug Designation (ODD) to a drug or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 individuals in the United States, or a patient population greater than 200,000 individuals in the United States and when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. ODD must be requested before submitting a BLA. After the FDA grants ODD, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. ODD does not convey any advantage in or shorten the duration of the regulatory review and approval process.

In the United States, ODD entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers. In addition, if a product that has ODD subsequently receives the first FDA approval for a particular drug or biologic for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full BLA, to market the same biologic for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or if the FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Orphan product exclusivity also could block the approval of one of our products for seven years if a competitor obtains approval of the same biological product as defined by the FDA or if our product candidate is determined to be contained within the competitor’s product for the same indication or disease.

A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received the ODD. In addition, Orphan Drug exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation was materially defective or, as noted above, if a second applicant demonstrates that its product is clinically superior to the approved product with orphan exclusivity or the manufacturer of the approved product is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.28

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FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Orphan product exclusivity also could block the approval of one of our products for seven years if a competitor obtains approval of the same biological product as defined by the FDA or if our product candidate is determined to be contained within the competitor’s product for the same indication or disease.

Post-Approval Requirements

Biologics are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing, annual program fees for any marketed products. Biologic manufacturers and other entities involved in the manufacture and distribution of approved biological products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP requirements and other laws. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance. Changes to the manufacturing process or facility are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post‑marketing studies or clinical trials to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things: restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; fines, warning letters or untitled letters; clinical holds on clinical trials; refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals; product seizure or detention, or refusal to permit the import or export of products; consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs; mandated modification of promotional materials and labeling and the issuance of corrective information; the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or injunctions or the imposition of civil or criminal penalties.

23The FDA closely regulates the marketing, labeling, advertising and promotion of biologics. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. FDA sanctions could include refusal to approve pending applications, withdrawal of an approval, clinical hold, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits or civil or criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe, in their independent medical judgment, that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict sponsors’ communications on the subject of off-label use of their products.

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regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post‑market studies or clinical trials to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

•restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;

•fines, warning letters or untitled letters;

•clinical holds on clinical trials;

•refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;

•product seizure or detention, or refusal to permit the import or export of products;

•consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

•mandated modification of promotional materials and labeling and the issuance of corrective information;

•the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; or

•injunctions or the imposition of civil or criminal penalties.

The FDA closely regulates the marketing, labeling, advertising and promotion of biologics. A company can make only those claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. FDA sanctions could include refusal to approve pending applications, withdrawal of an approval, clinical hold, warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits or civil or criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe, in their independent medical judgment, that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.

Biosimilars and Reference Product Exclusivity

The ~~Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA), includes a subtitle called the~~ Biologics Price Competition and Innovation Act (BPCIA), ~~which~~ created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars.

Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency, can be shown through analytical studies, animal studies and a clinical trial or trials. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as the reference product in any given patient and, for products that are administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. However, complexities associated with the larger, and often more complex, structures of biological products, as well as the processes by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval pathway that are still being worked out by the FDA.

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until twelve (12) years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s own nonclinical 29

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~~data~~relative ~~and~~to ~~data~~exclusive ~~from~~use ~~adequate~~of ~~and~~the ~~well-controlled~~reference ~~clinical~~biologic. ~~trials~~However, tocomplexities ~~demonstrate~~associated with the ~~safety~~larger, ~~purity~~ and ~~potency~~often ofmore ~~its~~complex, ~~product.~~structures ~~The~~of ~~BPCIA~~biological ~~also~~products, ~~created~~as ~~certain~~well ~~exclusivity~~as ~~periods~~the ~~for~~processes ~~biosimilars~~by ~~approved~~which assuch ~~interchangeable~~ products. Atare ~~this juncture~~manufactured, itpose issignificant ~~unclear~~hurdles ~~whether~~to ~~products~~implementation ~~deemed~~of ~~“interchangeable” by~~ the ~~FDA~~abbreviated ~~will,~~approval inpathway ~~fact,~~that beare ~~readily~~still ~~substituted~~being byworked ~~pharmacies,~~out ~~which are governed~~ by ~~state~~the ~~pharmacy law~~FDA.

AUnder ~~biological~~the ~~product~~BPCIA, ~~can~~an ~~also~~application ~~obtain~~for ~~pediatric~~a ~~market~~biosimilar ~~exclusivity~~product inmay ~~the~~not ~~United~~be ~~States.~~submitted ~~Pediatric~~to ~~exclusivity,~~the ifFDA ~~granted,~~until ~~adds~~four ~~six~~years ~~months~~following tothe ~~existing~~date ~~exclusivity~~that ~~periods~~the ~~and~~reference ~~patent~~product ~~terms.~~was ~~This~~first ~~six-month~~licensed ~~exclusivity,~~by ~~which~~the ~~runs~~FDA. ~~from~~In addition, the ~~end~~approval of ~~other~~a ~~exclusivity~~biosimilar ~~protection~~product ~~or patent term,~~ may not be ~~granted~~made ~~based~~effective onby the ~~voluntary~~FDA ~~completion~~until oftwelve a(12) ~~pediatric~~years ~~study~~from inthe ~~accordance~~date ~~with~~on anwhich ~~FDA-issued~~the ~~“Written~~reference ~~Request”~~product ~~for~~was ~~such~~first ~~a study~~licensed. ~~The~~During ~~BPCIA~~this is12-year ~~complex~~period ~~and~~of ~~continues~~exclusivity, toanother becompany ~~interpreted~~may ~~and~~still ~~implemented~~market bya competing version of the ~~FDA.~~reference Inproduct ~~addition,~~if ~~government~~the ~~proposals~~FDA ~~have~~approves ~~sought~~a tofull ~~reduce~~BLA for the ~~12-year~~competing ~~reference~~ product ~~exclusivity~~containing ~~period.~~that ~~Other~~applicant’s ~~aspects~~own ofnonclinical ~~the~~data ~~BPCIA,~~and ~~some~~data offrom ~~which~~adequate ~~may~~and ~~impact~~well-controlled ~~the~~clinical ~~BPCIA~~trials ~~exclusivity~~to ~~provisions,~~demonstrate ~~have~~the ~~also~~safety, ~~been~~purity ~~the~~and ~~subject~~potency of ~~recent~~its ~~litigation~~product. AsThe aBPCIA ~~result,~~also ~~the~~created ~~ultimate~~certain ~~impact,~~exclusivity ~~implementation~~periods ~~and~~for ~~impact~~biosimilars ofapproved ~~the~~as ~~BPCIA~~interchangeable ~~is subject to significant uncertainty~~products.

A biological product can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request” for such a study. The BPCIA is complex and continues to be interpreted and implemented by the FDA. In addition, government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate impact and implementation of the BPCIA is subject to significant uncertainty.

Government Regulation Outside of the United States

In addition to regulations in the United States, we may be subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales and distribution of our products. Because biologically sourced raw materials are subject to unique contamination risks, their use may be restricted in some countries. Whether or not we obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical trials or marketing of the product in those countries. Certain countries outside of the United States have a similar process that requires the submission of a clinical trial application much like the IND prior to the commencement of human clinical trials.

The requirements and process governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In all cases, clinical trials must be conducted in accordance with GCP, applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.

Applications for marketing approval in the EU and other ~~third~~ countries must also follow detailed laws and procedures that vary from those in the US.

Moreover, in countries outside of the USU.S., including the EU and countries in Eastern Europe, Latin America or Asia, the requirements governing product licensing, pricing and reimbursement vary from country to country.

If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

Other ~~Healthcare~~ Laws

Pharmaceutical companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business and may constrain the financial arrangements and relationships through which we research, sell, market and distribute any products for which we obtain marketing approval. Such laws include, without limitation, the U.S. Foreign Corrupt Practices Act of 1977 (FCPA), federal and state anti-kickback, fraud and abuse, false claims, data privacy and security, price reporting and physician and other health care provider transparency laws and regulations. If our operations are found to be in violation of any of such laws or any other governmental regulations that apply, we may be subject to penalties, including, without limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations, integrity oversight and reporting obligations, exclusion from participation in federal and state healthcare programs and imprisonment.

The ~~federal~~FCPA ~~Anti-Kickback Statute~~ prohibits, ~~among other things,~~ any ~~person~~U.S. individual or ~~entity,~~business from ~~knowingly~~paying, ~~and willfully~~ offering, ~~paying, soliciting~~ or ~~receiving~~authorizing ~~any~~payment ~~remuneration, directly~~ or ~~indirectly,~~offering ~~overtly~~of oranything ~~covertly~~of value, indirectly ~~cash~~ or ~~in kind~~indirectly, to ~~induce~~any orforeign ~~in return for purchasing~~official, ~~leasing,~~political ~~ordering~~party or ~~arranging~~candidate for the ~~purchase,~~purpose ~~lease or order~~ of influencing any ~~item~~act or ~~service~~decision ~~reimbursable under Medicare, Medicaid or other federal healthcare programs. The term remuneration has been interpreted broadly to include anything~~ of ~~value.~~the ~~The~~foreign ~~Anti-Kickback~~entity ~~Statute~~in ~~has~~order ~~been interpreted~~ to ~~apply~~assist ~~to arrangements between pharmaceutical manufacturers on~~ the ~~one~~individual ~~hand~~or ~~and~~business ~~prescribers,~~in ~~purchasers~~obtaining ~~and~~or ~~formulary~~retaining ~~managers on the other~~business. ~~There~~The ~~are~~FCPA aalso ~~number~~obligates ofcompanies ~~statutory~~whose ~~exceptions~~securities ~~and regulatory safe harbors protecting some common activities from prosecution. The exceptions and safe harbors~~ are ~~drawn~~listed ~~narrowly~~in ~~and~~the ~~practices~~United ~~that~~States ~~involve remuneration that may be alleged~~ to becomply ~~intended~~with toaccounting ~~induce~~provisions ~~prescribing,~~requiring ~~purchasing~~us ~~or recommending may be subject~~ to ~~scrutiny~~maintain ifbooks ~~they~~and dorecords ~~not~~that ~~qualify~~accurately ~~for~~and anfairly ~~exception~~reflect orall ~~safe~~transactions ~~harbor~~of ~~but~~ the ~~exceptions~~corporation, ~~and~~including ~~safe~~international ~~harbors~~subsidiaries, ~~are drawn narrowly~~ and ~~require strict compliance in order~~ to ~~offer~~devise ~~protection.~~and ~~Failure~~maintain toan ~~meet~~adequate ~~all~~system of ~~the~~internal ~~requirements~~accounting ofcontrols afor ~~particular~~international ~~applicable~~operations. ~~statutory exception or regulatory~~

25The federal Anti-Kickback Statute prohibits, among other things, any person or entity, from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in

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~~safe~~kind, ~~harbor~~to ~~does~~induce ~~not~~or ~~make~~in ~~the~~return ~~conduct~~for ~~per~~purchasing, seleasing, ~~illegal~~ordering ~~under~~or ~~the~~arranging ~~Anti-Kickback~~for ~~Statute.~~the ~~Instead~~purchase, ~~the~~lease ~~legality~~or order of ~~the~~any ~~arrangement~~item ~~will~~or beservice ~~evaluated~~reimbursable onunder aMedicare, ~~case-by-case~~Medicaid ~~basis~~or ~~based~~other onfederal ahealthcare ~~cumulative review of all of its facts and circumstances~~programs.

~~Additionally,~~The ~~the intent standard under the Anti-Kickback Statute and the criminal healthcare fraud statutes under the~~ federal ~~Health~~False ~~Insurance~~Claims ~~Portability and Accountability~~ Act ~~of 1996~~ (asFCA) ~~amended~~prohibits, byamong ~~the~~other ~~Health Information Technology for Economic and Clinical Health Act~~things, ~~HIPAA)~~any ~~was amended by the ACA to a stricter standard such that a~~ person or entity nofrom ~~longer~~knowingly ~~needs~~presenting, ~~to have actual knowledge of the statute~~ or ~~specific~~causing ~~intent~~ to ~~violate~~be itpresented, ina ~~order~~false toclaim ~~have~~for ~~committed~~payment ato, ~~violation.~~or Inapproval ~~addition~~by, the ~~ACA~~federal ~~codified~~government ~~case~~or ~~law~~knowingly ~~that~~making, ausing ~~claim~~or ~~including~~causing ~~items~~to orbe ~~services~~made ~~resulting~~or ~~from~~used a ~~violation~~false ofrecord ~~the~~or ~~federal~~statement ~~Anti-Kickback~~material ~~Statute~~to ~~constitutes~~ a false or fraudulent claim ~~for~~to ~~purposes of~~ the federal ~~False Claims Act (FCA) (discussed below)~~government.

The ~~FCA~~federal ~~prohibits,~~Health ~~among~~Insurance ~~other~~Portability ~~things,~~and ~~any~~Accountability ~~person~~Act orof ~~entity from knowingly presenting~~1996, oras ~~causing~~amended toby bethe ~~presented,~~Health aInformation ~~false~~Technology ~~claim~~ for ~~payment~~Economic ~~to,~~and orClinical ~~approval~~Health ~~by,~~Act ~~the~~(HITECH) ~~federal~~(as ~~government~~amended, ~~or knowingly making~~HIPAA), ~~using~~also orcreated ~~causing~~federal tocriminal bestatutes ~~made~~that orprohibit ~~used~~knowingly aand ~~false~~willfully ~~record~~executing, or ~~statement~~attempting ~~material~~ to execute, a ~~false~~scheme orto ~~fraudulent~~defraud ~~claim~~or to ~~the~~obtain, ~~federal~~by ~~government.~~means ~~As a result~~ of afalse ~~modification~~or ~~made~~fraudulent bypretenses, ~~the~~representations ~~Fraud~~or ~~Enforcement and Recovery Act of 2009~~promises, ~~a claim includes “~~any ~~request~~money or ~~demand”~~property ~~for~~owned ~~money~~by, or ~~property~~under ~~presented to~~ the ~~U.S.~~control ~~government.~~or ~~Pharmaceutical~~custody ~~and~~of, ~~other~~any healthcare ~~companies~~benefit ~~have~~program, ~~been~~including ~~prosecuted~~private ~~under~~third-party ~~these~~payors ~~laws~~and ~~for~~knowingly ~~allegedly~~and ~~providing~~willfully ~~free~~falsifying, ~~product~~concealing toor ~~customers~~covering ~~with~~up ~~the~~by ~~expectation~~trick, ~~that~~scheme ~~the~~or ~~customers~~device, ~~would~~a ~~bill~~material ~~federal~~fact ~~programs~~or ~~for~~making ~~the~~any ~~product~~materially ~~and for causing~~ false, ~~claims~~fictitious toor befraudulent ~~submitted~~statement ~~because~~in ofconnection with the ~~companies’~~delivery ~~marketing~~ of ~~the~~or ~~product~~payment for ~~unapproved~~healthcare benefits, ~~and~~items ~~thus~~or ~~non-covered, uses~~services.

~~HIPAA~~Additionally, ~~also~~the ~~created new~~ federal ~~criminal~~Physician ~~statutes~~Payments ~~that~~Sunshine ~~prohibit~~Act, ~~knowingly~~ and ~~willfully~~its ~~executing,~~implementing ~~or attempting to execute~~regulations, arequire ~~scheme~~that tocertain ~~defraud~~manufacturers orof tocommercial ~~obtain~~drugs, ~~by means of false or fraudulent pretenses~~devices, ~~representations~~biological orand ~~promises,~~medical ~~any~~supplies ~~money~~for orwhich ~~property~~payment ~~owned~~is ~~by,~~available or under ~~the~~Medicare, ~~control~~Medicaid or ~~custody~~the ~~of,~~Children’s ~~any~~Health ~~healthcare~~Insurance ~~benefit~~Program ~~program,~~(with ~~including~~certain ~~private~~exceptions) ~~third-party~~annually ~~payors~~report ~~and~~information ~~knowingly~~related ~~and~~to ~~willfully~~certain ~~falsifying,~~payments ~~concealing~~ or ~~covering~~other uptransfers byof ~~trick,~~value ~~scheme~~made or ~~device,~~distributed ato ~~material~~physicians ~~fact~~(defined orto ~~making~~include ~~any~~doctors, ~~materially~~dentists, ~~false~~optometrists, ~~fictitious~~podiatrists orand ~~fraudulent statement in connection with the delivery of or payment for healthcare benefits~~chiropractors), ~~items~~other orhealth ~~services.~~care ~~Also,~~professionals ~~many~~(such ~~states~~as ~~have~~physician ~~similar~~assistants ~~fraud~~ and ~~abuse~~nurse ~~statutes~~practitioners) orand ~~regulations~~teaching ~~that~~hospitals ~~apply to items~~ and ~~services~~certain ~~reimbursed~~ownership ~~under Medicaid~~ and ~~other~~investment ~~state~~interests ~~programs,~~held ~~or,~~by inthese ~~several~~physicians ~~states,~~and ~~apply~~their ~~regardless~~immediate offamily ~~the payor~~members.

~~Additionally,~~We ~~the~~may ~~federal~~also ~~Physician~~be ~~Payments~~subject ~~Sunshine~~to ~~Act~~data ~~within~~privacy ~~the ACA,~~ and ~~its~~security ~~implementing~~ regulations, ~~require~~by ~~that~~both ~~certain~~the ~~manufacturers~~federal ofgovernment ~~commercial drugs, devices, biological~~ and ~~medical~~the ~~supplies~~states ~~for~~in which ~~payment~~we isconduct ~~available~~our ~~under~~business. ~~Medicare,~~HIPAA ~~Medicaid~~imposes orrequirements ~~the~~on ~~Children’s~~covered ~~Health~~entities, ~~Insurance~~including ~~Program (with~~ certain ~~exceptions)~~healthcare ~~annually~~providers, ~~report~~health ~~information~~plans, ~~related~~healthcare toclearinghouses ~~certain~~and ~~payments~~their orrespective ~~other~~business ~~transfers~~associates ofthat ~~value made or distributed to physicians (defined to include doctors~~create, ~~dentists~~receive, ~~optometrists,~~maintain ~~podiatrists~~or ~~and~~transmit ~~chiropractors),~~individually ~~other~~identifiable health ~~care~~information ~~professionals~~for ~~(such~~or ason ~~physician~~behalf ~~assistants~~of ~~and~~a ~~nurse~~covered ~~practitioners)~~entity ~~and~~as ~~teaching~~well ~~hospitals~~as ~~and~~their ~~certain~~covered ~~ownership~~subcontractors ~~and~~relating ~~investment~~to ~~interests~~the ~~held~~privacy, bysecurity ~~these~~and ~~physicians~~transmission ~~and~~of ~~their~~individually ~~immediate~~identifiable ~~family~~health ~~members~~information.

We may also be subject to ~~data~~foreign ~~privacy~~ and ~~security~~state ~~regulations~~law byequivalents ~~both~~of each of the federal ~~government~~laws ~~and~~described ~~the~~above, ~~states~~such inas ~~which~~anti-kickback weand ~~conduct~~false ~~our~~claims ~~business.~~laws ~~HIPAA,~~which asmay ~~amended~~apply byto ~~the~~items ~~Health~~or ~~Information~~services ~~Technology~~reimbursed ~~for~~by ~~Economic~~state ~~and~~health ~~Clinical~~insurance ~~Health~~programs ~~Act~~or ~~(HITECH)~~any ~~and~~third-party ~~its implementing regulations~~payor, ~~impose~~including ~~requirements~~commercial oninsurers. ~~covered entities~~Further, ~~including~~in ~~certain~~order ~~healthcare~~to ~~providers,~~distribute ~~health~~products ~~plans~~commercially, ~~healthcare~~we ~~clearinghouses~~must ~~and~~comply ~~their~~with ~~respective~~state ~~business~~laws ~~associates~~ that ~~create,~~require ~~receive,~~the ~~maintain~~registration orof ~~transmit~~manufacturers ~~individually~~and ~~identifiable~~wholesale ~~health~~distributors ~~information~~of ~~for~~pharmaceutical orproducts onin ~~behalf~~a ofstate, aincluding, ~~covered~~in ~~entity~~certain asstates, ~~well~~manufacturers asand ~~their~~distributors ~~covered~~who ~~subcontractors~~ship ~~relating~~products tointo the ~~privacy,~~state ~~security~~even ~~and~~if ~~transmission~~such manufacturers or distributors have no place of ~~individually~~business ~~identifiable~~within ~~health~~the ~~information~~state. ~~Among~~Some ~~other~~states ~~things,~~also ~~HITECH~~impose ~~makes~~requirements ~~HIPAA’s~~on ~~privacy~~manufacturers and ~~security~~distributors ~~standards~~to ~~directly~~establish ~~applicable~~the topedigree ~~business~~of ~~associates,~~product ~~independent~~in ~~contractors~~the orchain ~~agents~~ of ~~covered~~distribution, ~~entities~~including some states that ~~receive~~require ormanufacturers ~~obtain~~and ~~protected~~others ~~health~~to ~~information~~adopt innew ~~connection~~technology ~~with~~capable ~~providing~~of atracking ~~service~~and ontracing ~~behalf~~product ofas ait ~~covered~~moves ~~entity~~through the distribution chain. ~~HITECH~~Several ~~also~~states ~~created~~have ~~four~~enacted ~~new~~legislation ~~tiers~~requiring ofpharmaceutical ~~civil~~companies ~~monetary~~to ~~penalties~~establish marketing compliance programs, ~~amended~~file ~~HIPAA~~periodic toreports ~~make~~with ~~civil~~the ~~and~~state, ~~criminal~~make ~~penalties~~periodic ~~directly~~public ~~applicable~~disclosures toon ~~business~~sales, ~~associates~~marketing, pricing, track and ~~gave~~report ~~state~~gifts, ~~attorneys~~compensation ~~general~~and ~~new~~other ~~authority~~remuneration made to ~~file~~physicians ~~civil~~and ~~actions~~other ~~for~~healthcare ~~damages~~providers, orclinical ~~injunctions~~trials inand ~~federal~~other ~~courts~~activities, toand/or ~~enforce~~register ~~the~~their ~~federal~~sales ~~HIPAA~~representatives, ~~laws~~as ~~and~~well ~~seek~~as ~~attorneys’~~to ~~fees~~prohibit pharmacies and ~~costs~~other ~~associated~~healthcare ~~with~~entities ~~pursuing~~from ~~federal~~providing ~~civil~~certain ~~actions.~~physician Inprescribing ~~addition,~~data ~~state~~to ~~laws~~pharmaceutical ~~govern~~companies ~~the~~for ~~privacy~~use ~~and~~in ~~security~~sales ofand ~~health~~marketing, ~~information~~and into ~~specified~~prohibit ~~circumstances,~~certain ~~many~~other ofsales ~~which~~and ~~differ~~marketing ~~from~~practices. ~~each~~All ~~other~~of inour ~~significant~~activities ~~ways~~are ~~and~~potentially ~~may~~subject ~~not~~to ~~have~~federal ~~the~~and ~~same~~state ~~effect,~~consumer ~~thus~~protection ~~complicating~~and ~~compliance~~unfair ~~efforts~~competition laws.

InIf ~~order~~our tooperations ~~distribute~~are ~~products~~found ~~commercially,~~to webe ~~must~~in ~~comply~~violation ~~with state laws that require the registration~~ of ~~manufacturers~~any ~~and wholesale distributors~~ of ~~pharmaceutical~~the ~~products~~healthcare inlaws adescribed ~~state,~~above ~~including,~~or inany ~~certain~~other ~~states~~federal, ~~manufacturers~~state ~~and~~or ~~distributors~~foreign ~~who~~laws ~~ship~~or ~~products~~governmental ~~into~~regulations ~~the~~that ~~state~~apply ~~even~~to ifus, ~~such~~we ~~manufacturers~~may orbe ~~distributors~~subject ~~have~~to nosignificant ~~place~~penalties, ofincluding ~~business~~without ~~within~~limitation, ~~the~~civil, ~~state.~~criminal ~~Some~~and/or ~~states~~administrative ~~also~~penalties, ~~impose~~damages, ~~requirements~~fines, ondisgorgement, ~~manufacturers~~imprisonment, ~~and~~exclusion ~~distributors~~from toparticipation ~~establish the pedigree of product~~ in ~~the~~government ~~chain of distribution~~programs, ~~including~~such ~~some~~as ~~states~~Medicare ~~that require manufacturers~~ and ~~others~~Medicaid, toinjunctions, ~~adopt~~private ~~new~~“qui ~~technology~~tam” ~~capable~~actions ofbrought ~~tracking~~by ~~and~~individual ~~tracing~~whistleblowers ~~product~~in asthe itname ~~moves~~of ~~through~~ the ~~distribution~~government, ~~chain.~~integrity ~~Several~~oversight ~~states~~and ~~have~~reporting ~~enacted~~obligations ~~legislation~~or ~~requiring~~refusal ~~pharmaceutical companies~~ to ~~establish~~allow ~~marketing~~us ~~compliance~~to ~~programs,~~enter ~~file~~into ~~periodic~~government ~~reports with the state~~contracts, ~~make~~contractual ~~periodic public disclosures on sales~~damages, ~~marketing,~~reputational ~~pricing~~harm, ~~track~~administrative ~~and report gifts~~burdens, ~~compensation~~diminished ~~and~~profits ~~other remuneration made to physicians~~ and ~~other~~future ~~healthcare providers~~earnings, ~~clinical trials~~ and ~~other~~the ~~activities,~~curtailment ~~and/~~or ~~register~~restructuring ~~their~~of ~~sales~~our ~~representatives~~operations, asany ~~well~~of aswhich tocould ~~prohibit~~adversely ~~pharmacies~~affect ~~and~~our ~~other~~ability ~~healthcare~~to ~~entities~~operate ~~from~~our ~~providing~~business ~~certain~~and ~~physician~~our ~~prescribing~~results ~~data~~of to operations.

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pharmaceutical companies for use in sales and marketing, and to prohibit certain other sales and marketing practices. All of our activities are potentially subject to federal and state consumer protection and unfair competition laws.

If our operations are found to be in violation of any of the federal and state healthcare laws described above or any other governmental regulations that apply to us, we may be subject to significant penalties, including without limitation, civil, criminal and/or administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions, private “qui tam” actions brought by individual whistleblowers in the name of the government, or refusal to allow us to enter into government contracts, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations

Coverage and Reimbursement

Sales of any product depend, in part, on the extent to which such product will be covered by third-party payors, such as federal, state and foreign government healthcare programs, commercial insurance and managed healthcare organizations, and the level of reimbursement for such product by third-party payors. Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that a product is safe, effective and medically necessary; appropriate for the specific patient; cost-effective; supported by peer-reviewed medical journals; included in clinical practice guidelines; and neither cosmetic, experimental, nor investigational. A third-party payor could also require that certain lines of therapy be completed or failed prior to reimbursing our therapy. The principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services (CMS), an agency within the U.S. Department of Health and Human Services (HHS). CMS decides whether and to what extent products will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. Third-party payors determine which products and procedures they will cover and establish reimbursement levels. Even if a third-party payor covers a particular product or procedure, the resulting reimbursement payment rates may not be adequate. Additionally, any companion diagnostic tests developed for use with a product are required to obtain coverage and reimbursement for those tests separate and apart from the coverage and reimbursement sought for such product. These third-party payors are increasingly reducing coverage and reimbursement for medical products, drugs and services. In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product. Decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could reduce physician usage and patient demand for the product and also have a material adverse effect on sales.

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effective and medically necessary; appropriate for the specific patient; cost-effective; supported by peer-reviewed medical journals; included in clinical practice guidelines; and neither cosmetic, experimental, nor investigational. A third-party payor could also require that certain lines of therapy be completed or failed prior to reimbursing our therapy. The principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services (CMS), an agency within the U.S. Department of Health and Human Services (HHS). CMS decides whether and to what extent products will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. Third-party payors determine which products and procedures they will cover and establish reimbursement levels. Even if a third-party payor covers a particular product or procedure, the resulting reimbursement payment rates may not be adequate. Additionally, any companion diagnostic tests developed for use with a product are required to obtain coverage and reimbursement for those tests separate and apart from the coverage and reimbursement sought for such product. These third-party payors are increasingly reducing coverage and reimbursement for medical products, drugs and services. In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product. Decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could reduce physician usage and patient demand for the product and also have a material adverse effect on sales.

Healthcare Reform

In the United States, in March 2010, the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA), was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers, and ~~significantly~~continues ~~affected~~to impact the pharmaceutical industry.

There have been executive, judicial and Congressional challenges and amendments to certain aspects of the ACA. ~~Further,~~On onJuly ~~August 16~~4, ~~2022~~2025, the ~~Inflation~~One ~~Reduction~~Big ~~Act~~Beautiful ofBill ~~2022~~Act (the ~~IRA~~OBBBA) was signed into law, which ~~among~~narrowed ~~other~~access ~~things,~~to ~~extends~~ACA ~~enhanced~~marketplace ~~subsidies~~exchange ~~for~~enrollment ~~individuals~~and ~~purchasing~~declined ~~health~~to ~~insurance~~extend ~~coverage~~the in ACA ~~marketplaces~~enhanced ~~through~~advanced ~~plan~~premium ~~year~~tax credits that expired at the end of 2025., ~~The~~which, ~~IRA~~among ~~also~~other ~~eliminates~~provisions in the ~~“donut~~law, ~~hole”~~are ~~under~~anticipated to reduce the ~~Medicare~~number ~~Part~~of DAmericans ~~program~~with ~~beginning~~health ininsurance. ~~2025~~The byOBBBA ~~significantly~~also ~~lowering~~is ~~the~~expected ~~beneficiary~~to ~~maximum~~reduce ~~out-of-pocket~~Medicaid ~~cost~~spending ~~through~~and aenrollment ~~newly~~by ~~established~~implementing ~~manufacturer~~work ~~discount~~requirements ~~program.~~for Itsome isbeneficiaries, ~~possible~~capping ~~that~~state-directed ~~the~~payments, ~~ACA~~reducing ~~will~~federal befunding ~~subject~~and tolimiting ~~additional~~provider ~~challenges~~taxes inused to fund the ~~future~~program. ItCongress is ~~unclear~~considering ~~how~~proposed ~~any~~legislation ~~such~~intended ~~additional~~to ~~challenges~~further ~~and~~reduce healthcare ~~reform~~costs ~~measures~~with ofalternatives to replace the ~~second~~expired ~~Trump~~ACA ~~administration~~subsidies. ~~will~~It ~~impact~~is possible that the ACA ~~and~~will ~~our~~be ~~business~~subject to additional challenges in the future.

Other legislative changes have also been proposed and adopted in the United States since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011, among other things, included aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began in 2013 and will remain in effect through 2032.

There has been heightened governmental scrutiny recently over the manner in which pharmaceutical companies set prices for their marketed products, which has resulted in several Congressional inquiries and proposed federal legislation, as well as state efforts, designed to, among other things, bring more transparency to product pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. ~~In addition, the IRA, among other things, (1) directs HHS to negotiate the price of certain high-expenditure, single-source biologics that have been on the market for at~~

27The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at HHS, the FDA, CMS and related agencies. Recent actions include (1) directing agencies to reduce agency workforce and cut programs; (2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives, including by improving upon the Medicare Drug Price Negotiation Program and establishing Most-Favored-Nation pricing for pharmaceutical products; (3) imposing tariffs on imported pharmaceutical products; and (4) as part of the Make America Healthy Again (MAHA) Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising. These actions and policies may significantly reduce U.S. drug prices, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks. In June 2024, the U.S. Supreme Court’s Loper Bright decision greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations. Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

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~~least~~These ~~eleven~~health ~~years~~reform ~~covered~~measures ~~under~~will ~~Medicare~~result ~~(the~~in ~~Medicare~~additional ~~Drug~~downward ~~Price~~pressure ~~Negotiation~~on ~~Program)~~coverage and ~~(2)~~the ~~imposes~~price ~~rebates~~that ~~under~~we ~~Medicare~~receive ~~Part~~for Bany ~~and~~approved ~~Medicare~~product ~~Part~~and Dcould toseriously ~~penalize~~harm ~~price~~our ~~increases that outpace inflation~~business. ~~These~~Any ~~provisions~~reduction ~~began to take effect progressively~~ in ~~fiscal~~reimbursement ~~year~~from ~~2023, although the~~ Medicare ~~Drug~~and ~~Price~~other ~~Negotiation~~government ~~Program~~programs ismay ~~currently~~result ~~subject~~in toa ~~legal~~similar ~~challenges.~~reduction Onin ~~August~~payments ~~15,~~from ~~2024,~~private ~~HHS~~payors. ~~announced~~The ~~the~~implementation ~~agreed-upon prices~~ of ~~the~~cost ~~first~~containment ~~ten~~measures ~~drugs~~or ~~that~~other ~~were~~healthcare ~~subject~~reforms tomay ~~price~~prevent ~~negotiations~~us ~~which~~from ~~take~~being ~~effect~~able into ~~January~~generate ~~2026. On January 17~~revenue, ~~2025,~~attain ~~HHS~~profitability ~~selected~~or ~~fifteen~~commercialize ~~additional~~our products covered under Part D for price negotiation in 2025. Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program. Further, on December 7, 2023, an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act of 1980 (~~Bayh-Dole~~if ~~Act~~approved) ~~was announced~~. ~~On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-~~In ~~Rights that for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised~~addition, it is ~~uncertain~~possible if that there will ~~continue~~be ~~under~~further ~~the new framework. At the state level, legislatures have increasingly passed~~ legislation ~~and implemented regulations designed to control pharmaceutical and biological product pricing, including price~~ or ~~patient~~regulation ~~reimbursement~~that ~~constraints,~~could ~~discounts,~~harm ~~restrictions~~our ~~on certain product access and marketing cost disclosure and transparency measures~~business, ~~and,~~financial incondition ~~some cases, designed to encourage importation from other countries~~ and ~~bulk~~results ~~purchasing~~of operations.

These health reform measures will result in additional downward pressure on coverage and the price that we receive for any approved product and could seriously harm our business. Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our products (if approved). In addition, it is possible that there will be further legislation or regulation that could harm our business, financial condition and results of operations, particularly in light of the recent U.S. Presidential and Congressional elections.

Other Data Privacy and Security Laws

In the ordinary course of our business, we process or receive personal or sensitive data. We are, or may become, subject to numerous data privacy and security obligations, including federal, state, local and foreign laws, regulations, guidance and industry standards related to data privacy and security in the jurisdictions in which we are established or in which we sell or market any approved products or run clinical trials. Such ~~obligations~~laws may include those from, without limitation, the Federal Trade Commission Act, the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act of 2020 (CPRA) (collectively, CCPA), the EU’s General Data Protection Regulation 2016/679 (EU GDPR), the EU GDPR as it forms part of UK law by virtue of section 3 of the European Union (Withdrawal) Act 2018 (UK GDPR) and the ePrivacy Directive. Several states within the United States have also enacted or proposed comprehensive data privacy and security laws. ~~For example, Virginia passed the Consumer Data Protection Act, and Colorado passed the Colorado Privacy Act.~~ Additionally, we are, or may become, subject to various U.S. federal and state consumer protection laws, which require us to publish statements that accurately and fairly describe how we handle personal data and choices individuals may have about the way we handle their personal data.

The CCPA, CPRA and EU GDPR are examples of the increasingly stringent and evolving regulatory frameworks related to personal data processing that may increase our compliance obligations and exposure for any noncompliance. For example, the CCPA imposes obligations on covered businesses to provide specific disclosures related to a business’ collecting, using and disclosing personal data and to ~~respond~~honor to certain requests from California residents related to their personal data ~~(for example, requests to know of the business’ personal data processing activities, to delete the individual’s personal data and to opt out of certain personal data disclosures)~~. Also, the CCPA provides for civil penalties and a private right of action for data breaches that may include an award of statutory damages. In addition, the CPRA expanded the CCPA by giving California residents the ability to limit use of certain sensitive personal data, establishing restrictions on personal data retention, expanding the types of data breaches that are subject to the CCPA’s private right of action and establishing a new California Privacy Protection Agency to implement and enforce the new law.

Foreign data privacy and security laws (including but not limited to the EU GDPR and UK GDPR) impose significant and complex compliance obligations on entities that are subject to those laws. As one example, the EU GDPR applies to any company established in the European Economic Area, ~~which is comprised of the 27 Member States of the EU plus Norway, Iceland and Liechtenstein~~ (~~collectively, the~~ EEA) and to companies established outside the EEA that process personal data in connection with the offering of goods or services to data subjects in the EEA or the monitoring of the behavior of data subjects in the EEA. ~~These~~Under ~~obligations~~the ~~include~~GDPR, ~~limiting~~companies ~~personal~~may ~~data~~face ~~processing~~temporary toor ~~only~~definitive ~~what~~bans ison ~~necessary~~data ~~for~~processing ~~specified, explicit~~ and ~~legitimate~~other ~~purposes~~corrective actions; ~~requiring~~fines aof ~~legal~~up ~~basis~~to ~~for~~20 ~~personal~~million ~~data~~Euros ~~processing;~~under ~~requiring~~ the ~~appointment~~EU ofGDPR; a17.5 ~~data~~million ~~protection~~pounds ~~officer~~sterling inunder ~~certain~~the ~~circumstances;~~UK ~~increasing~~GDPR ~~transparency~~or, ~~obligations~~in toeach ~~data~~case, ~~subjects;~~4% ~~requiring~~of ~~data~~the ~~protection~~annual ~~impact~~global ~~assessments~~revenue, inwhichever ~~certain~~is ~~circumstances~~greater; ~~limiting~~or ~~the~~private ~~collection~~litigation ~~and~~related ~~retention~~to processing of personal data; ~~increasing~~brought ~~rights~~by ~~for~~classes of data subjects; ~~formalizing~~or aconsumer ~~heightened~~protection ~~and~~organizations ~~codified~~authorized ~~standard~~at oflaw ~~data~~to ~~subject~~represent ~~consents;~~their ~~requiring~~interests.

28See the section titled “Risks Related to Our Business and Industry” for additional information about the laws and regulations to which we may become subject and about the risks to our business associated with such laws and regulations.

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the implementation and maintenance of technical and organizational safeguards for personal data; mandating notice of certain personal data breaches to the relevant supervisory authorities and affected individuals; and mandating the appointment of representatives in the UK and/or the EU in certain circumstances.

See the section titled “Risks Related to Regulation and Legal Compliance” for additional information about the laws and regulations to which we may become subject and about the risks to our business associated with such laws and regulations.

The U.S. Foreign Corrupt Practices Act

The U.S. Foreign Corrupt Practices Act of 1977 (FCPA), prohibits any U.S. individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring us to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations.

Employees and Human Capital Management

Our Mission

We are a late-stage clinical cell therapy company ~~entering pivotal trials and~~ advancing a pipeline of proprietary next‑-generation autologous CAR T-cell product candidates for patients with cancer. WeOur ~~are~~goal ~~pioneering~~is ~~novel~~to ~~approaches~~fully ~~designed~~realize tothe ~~generate~~curative Tpotential ~~cells~~of ~~that~~cell ~~drive~~therapy ~~long-lasting~~for ~~clinical~~patients ~~response~~with hematologic malignancies and solid tumors. We strive to create an environment where everyone can do their best work, be themselves, and thrive personally and professionally. Our culture is grounded by innovative science and a ~~focus~~passion onto ~~patients~~identify ~~with~~and ~~cancer~~deliver ~~who need~~ better therapies for patients. ~~Their~~The ~~need~~needs ~~drives~~of patients drive our sense of urgency to achieve our important mission.

Our Values

We believe success comes when we align our core values with our mission; tothis ~~translate~~gives ~~our~~us ~~ground-breaking~~focus ~~science~~and ~~into~~direction ~~therapies~~in ~~with~~how ~~the~~we ~~potential~~do toour ~~transform patients’ lives~~work. Our core values are:

• Science: We value evidence over opinion and we focus and execute on the critical efforts that matter most.

• Courage: We challenge the status quo – we are bold and willing to think and act differently.

• Respect: We operate with positive intent and seek to understand and communicate directly, transparently and honestly.

~~• Collaboration: We work together to create value, working across teams to solve our most challenging problems to continually improve and learn.~~33

InTable 2024, with active participation from our employees, we created behavior expectations to describe how Lyellites demonstrate our values at work. Leaders and employees attended workshops where we defined behavior statements that have been embedded in our performance management and development programs. These behaviors exemplify our values as well as principles of ~~patient-centricity, innovation and inclusion.~~ Contents

•Collaboration: We work together to create value, working across teams to solve our most challenging problems to continually improve and learn.

Our values are further defined as specific ways of working that are embedded in our performance management processes. Our ways of working, or the Lyell Behaviors, exemplify our values as well as principles of patient-centricity, innovation and inclusion. High performers at Lyell not only achieve their goals, but consistently and effectively demonstrate the Lyell Behaviors.

Our Employees

Our people drive our mission. We compete in the highly competitive biotechnology industry,; ~~and~~ attracting, retaining and developing a diverse group of talented employees is crucial to our strategy and we believe is a competitive advantage. ~~Our~~What ~~organization~~sets Lyell apart from our peers is ~~designed~~the tobreadth ~~support~~of work we do; from discovery research, ~~product~~to drug development and manufacturing, ~~efforts~~we ~~and~~are isa ~~ready~~high-performing toteam ~~scale~~across toour ~~meet~~many ~~future~~functions. ~~plans~~Lyell ~~for~~provides ~~commercializing~~the ~~our~~opportunity ~~product~~to ~~candidates,~~see iffirst-hand ~~approved.~~how Acell ~~strategic~~therapy ~~priority~~ is ~~attracting~~brought ~~and~~to ~~retaining~~life ~~talent~~and ~~with~~gives ~~the~~employees ~~skills~~opportunities weto ~~need~~engage ~~now~~ and inmake ~~the~~meaningful ~~future~~contributions. The labor market continues to reflect a limited pool of skilled individuals with substantial experience discovering, developing and manufacturing cell therapy medicines~~, and we expect this is likely to continue~~. ~~We also operate in areas such as data capture and analytics.~~ As awe ~~result,~~plan ~~competition~~ for ~~talent~~commercialization, isthis ~~intense~~level ~~and~~of ~~the~~competition ~~turnover~~will ~~rate~~continue ~~can~~to be ~~high.~~a Wechallenge, ~~face substantial competition among numerous biopharmaceutical companies~~ and ~~academic institutions as well as technology companies for individuals with these skills. For these reasons,~~ we will continue to ~~develop~~compete ~~our~~for ~~culture~~talent ~~through~~against ~~people~~businesses ~~systems~~ that ~~establish~~are ~~clear~~much ~~expectations,~~larger ~~ensure employees have ongoing feedback~~ and ~~provide~~more ~~opportunities~~heavily ~~for skill and career development as well as competitive pay and benefits~~resourced.

AsConsidering ofthese ~~December 31~~challenges, ~~2024,~~our weculture ~~had~~is ~~300~~central to our strategy to retain and engage our employees, ~~over~~made ~~83%~~real by the work of ~~whom~~employees ~~were~~and ~~engaged~~leaders. Grounded in ~~research~~our values and ~~development activities~~behaviors, ~~technical~~we ~~operations~~foster ~~and~~a ~~process~~collaborative ~~sciences~~community across our three locations. ~~Our~~Employee-led initiatives, anchored by employees ~~are~~from ~~highly~~various ~~skilled~~levels at each of our sites and sponsored by our Executive Leaders, celebrate individuals and ~~many~~diverse ~~hold~~perspectives ~~advanced~~through ~~degrees~~monthly activities and recognition events. We rally as one team to support local organizations in the San Francisco Bay Area and Seattle Region as part of April Volunteer Month, as well as with our support to Blood Cancer United’s Light the Night event in San Francisco and Seattle.

29Leaders at Lyell recognize the important role they play in attracting, retaining and engaging our people. To that end, leaders are guided by our Talent Philosophy. Five components make up our Talent Philosophy:

•Performance is a constant focus of our organization; we set stretch goals and strive for exceptional outcomes that bring our innovative treatments to patients and differentiate to recognize high performance

•Behaviors translate our values into action. We demonstrate these behaviors as they lead to high performance and foster a workplace where each of us can do our best work

•Development is a mindset that means all employees can build their skills and increase their capabilities; leaders guide development of their team members

•Transparency is ensured by our leaders so that individuals understand what is expected of them and know where they stand throughout the year

•Accountability is key to ensuring Lyellites are proud of their work and take ownership; leaders are accountable to their people and have a priority to develop and grow their team members

Our Talent Philosophy is a blueprint for leadership. Leaders take seriously the role they play in creating a place where employees feel valued and engaged. Our people management processes place emphasis on establishing clear expectations, providing routine, ongoing feedback and creating opportunities to learn and develop in the current role, as well as in preparation for progression within the company.

As of December 31, 2025, we had 161 employees, over 80% of whom were engaged in research and development activities, technical operations and process sciences. Our employees are highly skilled, and many hold advanced degrees. Many of our employees have experience with the development of cell therapies. Most of our employees are located in California and Washington, with all employees based in the United States. None of our employees are subject to a collective bargaining agreement nor represented by labor unions. We value our relationship with our employees and evaluate this as good given our Great Place to Work certification in 2024 where 81% of employees participated. To track our progress, we conducted a 2025 pulse survey using Great Place to Work questions. Seventy-one percent of our staff participated, and 86% responded that Lyell is a great place to work.

Developing our employees is a central component of our Talent Philosophy. All employees have the opportunity for development and advancement. Starting with annual expectations, each employee has a development goal; this is one area of growth that will help the individual perform more effectively in their current role. Training, coaching, routine feedback, and a systematic approach to employee advancement are key components of our talent strategy. We hold talent discussions regularly, which include leaders discussing development aspirations of staff and aligning with talent plans in the Spring, identifying talent for promotion through our twice-yearly promotional review process and culminating in year-

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~~Many~~end ofperformance ~~our~~calibration ~~employees~~to ~~have~~ensure ~~experience~~we ~~with~~pay ~~the~~for ~~development of cell therapies~~performance. ~~The~~Our ~~majority~~talent ofis ~~our~~managed ~~employees~~on ~~are~~a ~~located~~foundation inof ~~California~~clear ~~and Washington~~expectations, ~~with~~ongoing ~~all~~feedback ~~employees~~and ~~based in the United States~~development. ~~None of our employees are subject to a collective bargaining agreement nor represented by labor unions. We consider our relationship with our employees to be good.~~

~~Developing~~Since ~~our~~inception, ~~employees~~voluntary isemployee ~~important,~~turnover ~~and~~at weLyell ~~focus~~has onremained ~~providing~~consistently ~~learning~~below ~~opportunities~~average ~~for~~compared ~~development~~to ~~and~~the ~~advancement~~U.S. ~~Training,~~life ~~coaching,~~sciences ~~routine~~industry ~~feedback~~generally, ~~and~~as awell ~~systematic~~as ~~approach~~for tolife ~~employee~~sciences ~~advancement~~companies ~~are~~located ~~key~~in ~~components~~Northern ofCalifornia ~~our~~and ~~talent~~the ~~strategy~~Pacific Northwest. WeTo ~~hold~~retain ~~talent~~and ~~discussions~~attract ~~regularly~~talent, ~~which~~we ~~include~~continually ~~leaders~~assess ~~identifying~~employee ~~talent~~turnover, ~~for~~effectiveness ~~promotion across all functions. Foundations~~ of ~~our~~recruitment ~~talent~~initiatives, ~~management~~compensation ~~practice~~and ~~include~~benefits ~~career~~programs, ~~frameworks~~health ~~for progression~~ and ~~development~~safety practices, ~~individual~~inclusion ~~goal~~and ~~setting~~other ~~for~~matters ~~all~~relevant ~~staff including one development goal~~ to ~~continue~~human tocapital ~~improving~~management. ~~skills~~These ~~and~~outcomes ~~abilities in the current role~~ and aupdates ~~compensation~~are ~~approach~~routinely ~~that~~reviewed ~~recognizes~~with ~~differentiated~~our ~~performance~~executive leaders and ~~shares~~board ~~performance~~of ~~feedback regularly~~directors.

In 2024, we participated in the Great Place to Work survey for the first time and, based on employee responses to the survey, we received certification as a Great Place to Work. With 81% of employees participating in the survey, we received high ratings in multiple areas, with engagement, culture, inclusion and innovation being specific areas of strength. Employee feedback, through independent and anonymous surveys, provide us with the data on an ongoing basis that we need to ensure that our leadership, culture and people practices are supporting the talented workforce that we need to advance our mission.

Since inception, our employee turnover has remained consistently below average for the U.S. life sciences industry generally, as well as for life sciences companies located in Northern California and the Pacific Northwest. Given our need to retain and attract talent, we continually assess employee turnover, effectiveness of recruitment initiatives, compensation and benefits programs, health and safety practices, diversity and inclusion and other matters relevant to human capital management. These outcomes and updates are routinely reviewed with our board of directors.

Our Compensation and Benefits

Given the highly competitive nature of our industry and the importance of recruitment and retention to our success, we strive to provide our employees with what we believe is a competitive and comprehensive total rewards package of compensation, benefits and services. This package includes competitive market pay, healthcare benefits for employees and family members, a flexible spending ~~account~~accounts, or health savings ~~account~~accounts, paid time off benefits, family leave, flexible work schedules, flexible work locations, 401(k) matching, an employee assistance program and a wellness program. In addition, we offer employees the benefit of equity ownership in the company through stock option grants and/or restricted stock units. Our employees are also eligible to participate in an employee stock purchase plan, which offers the opportunity to purchase our common stock at a discount of 15%.

Our Commitment to ~~Diversity, Belonging,~~ Inclusion ~~and Equity~~

We strongly believe in a ~~diverse~~ workplace where all employees can thrive. inThis means an ~~inclusive~~ environment free from discrimination, harassment, bias and prejudice. We ~~aim~~intend to treat all individuals with respect and dignity and to provide ~~all~~each ~~employees~~employee with equal opportunity and fair treatment. By embracing ~~diversity and~~ inclusion, we ~~seek~~offer ~~to create~~ an organization committed to collaboration and innovation consistent with our values and in support of accomplishing our mission. Not only is a diverse, equitable and inclusive mindset and culture critical to an engaged and committed workplace, but it is also imperative to understanding and meeting the needs of the patients we seek to help with our medicines.

InOur ~~2020,~~compensation ~~with~~practices ~~the~~are ~~support~~reviewed ~~and~~regularly ~~sponsorship~~for offairness ~~our~~and ~~executive~~consistency. ~~leadership~~Ranges ~~team,~~of wecompensation ~~established a Diversity, Belonging, Inclusion~~ and ~~Equity~~other ~~(DBIE)~~components ~~working group comprised~~ of atotal ~~diverse~~compensation ~~group~~are ofbased ~~employees~~on ~~tasked~~benchmark ~~with~~data ~~designing~~refreshed ~~and~~annually ~~implementing~~using ~~specific~~externally ~~initiatives~~validated toinformation ~~promote~~from ~~greater~~peer ~~diversity, belonging, inclusion and equity at Lyell~~companies. WeWithin ~~continue~~this tocontext, ~~externally benchmark~~ our ~~efforts with respect to best~~ practices ~~across~~drive ~~industries.~~pay ~~The~~decisions ~~DBIE~~that ~~working~~position ~~group~~employees isequitably ~~guided~~within by a ~~collaboratively~~market-competitive ~~developed~~range, ~~DBIE~~taking ~~mission~~into ~~statement.~~consideration ~~The~~factors ~~working~~such ~~group~~as isrole, ~~comprised~~market ofdata ~~volunteers~~for ~~across~~similar ~~each~~roles ~~of our work locations representing various levels~~ in ~~the~~related ~~organization.~~industry, ~~This~~internal ~~team~~equity, ~~sponsored~~job bylocation, ~~our~~relevant ~~Chief~~experience ~~Executive~~and ~~Officer~~individual ~~and~~performance. ~~Senior~~Ongoing ~~Vice~~pay ~~President~~progression ofis ~~Human~~guided ~~Resources,~~by ~~creates~~our ancompensation ~~annual~~philosophy; ~~strategic~~we ~~and~~recognize ~~tactical~~differentiation ~~plan~~in torewards, ~~advance~~where our ~~focus~~highest onperforming ~~the~~employees ~~importance~~receive ofthe ~~DBIE~~highest torewards. ~~our~~At ~~culture.~~the ~~Our~~same ~~DBIE~~time, ~~team~~we ~~has~~monitor ~~continued~~for topay ~~develop~~equity; ~~and~~we ~~implement~~have ana ~~annual~~review ~~plan~~process that ~~includes~~is ~~many~~formally ~~opportunities~~conducted ~~for~~annually, ~~learning~~as ~~and~~well ~~engagement~~as ~~open~~ad-hoc toas ~~all~~requested ~~employees~~for review. InIf ~~addition~~we toidentify ~~the~~employees ~~DBIE~~with ~~employee~~unjustified ~~working~~pay ~~group,~~gaps ~~our~~that ~~Human~~do ~~Resources~~not ~~practices~~align ~~emphasize~~with ~~diversity~~our ~~and~~pay ~~inclusion as key indicators of success. Recruitment~~philosophy, ~~progression~~we review and ~~development~~take ~~processes~~appropriate ~~emphasize~~action ~~the~~to ~~importance~~ensure offidelity ~~fostering~~between ~~a workforce that is representative of~~ our ~~diverse~~stated ~~patient~~philosophy ~~population~~and actions.

Employee feedback from our Great Place to Work survey rated the organization very high on four key questions on inclusion: (1) People here are treated fairly regardless of their sexual orientation; (2) People here are treated fairly regardless of their race; (3) People here are treated fairly regardless of their gender; and (4) People here are treated fairly

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regardless of their age. We continue to evolve our workplace practices to ensure that our culture embeds fair treatment for all and is seen as a place where individuals can be their authentic selves at work. We have plans to continue to build on our early years and continue to mature our DEI strategy and practices in the years ahead working from this strong foundation.

We believe in equitable pay and our compensation practices are reviewed regularly. We establish components and ranges of compensation based on market and benchmark data. Within this context, we strive to pay all employees equitably within a market-competitive range, taking into consideration factors such as role, market data for similar roles in related industry, internal equity, job location, relevant experience and individual performance. Ongoing pay progression is guided by our compensation philosophy; we recognize differentiation in rewards, where our highest performing employees receive the highest rewards. At the same time, we are committed to pay equity; we have a review process that is conducted on at least an annual basis. If we identify employees with unjustified pay gaps that do not align with our pay philosophy, we review and take appropriate action to ensure fidelity between our stated philosophy and actions.

Available Information

We were incorporated in June 2018 under the laws of the state of Delaware. Our website address is www.lyell.com. We file annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Exchange Act. The Securities and Exchange Commission (SEC) maintains a website at www.sec.gov that contains reports, proxy and information statements and other information that we file with the SEC electronically. Copies of our reports on Form 10-K, Forms 10-Q, Forms 8-‑K and amendments to those reports may also be obtained, free of charge, electronically on the investor relations page on our website located at ir.lyell.com as soon as reasonably practical after we file such material with, or furnish it to, the SEC.

We also use the Investors page on our website as a channel of distribution for important company information. Important information, including press releases, corporate and scientific presentations and financial information regarding our company, as well as corporate governance information, is routinely posted and accessible on the Investors page on our website. Information on or that can be accessed through our website is not part of this Annual Report on Form 10-K, and the inclusion of our website address is an inactive textual reference only.

Item 1A. Risk Factors.

Our business involves significant risks, some of which are described below. You should carefully consider the risks described below, as well as the other information contained in this Annual Report on Form 10-K, including our audited consolidated financial statements and unaudited condensed consolidated financial statements and the related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of our common stock could decline and you may lose ~~all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.~~

~~Risks Related to Our Financial Condition, Limited Operating History and Need for Additional Capital~~35

We are a clinical-stage biopharmaceutical company that has incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing net losses for the foreseeable future.

Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to prove safe and effective, gain regulatory approval or become commercially viable. We are a clinical‑stage biopharmaceutical company that does not yet have any products approved by regulatory authorities for sale, and we have incurred significant research, development and other expenses related to our ongoing operations and expect to continue to incur such expenses. Since our inception, we have not generated any revenue from product sales and have incurred significant net losses. Substantially all of our net losses since inception have resulted from our research and development programs and general and administrative costs associated with our operations.

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~~from~~all ~~quarter~~or topart ~~quarter and year to year, such that a period-to-period comparison~~ of ~~our~~your ~~results of operations may not be a good indication of our future performance~~investment. IfAdditional ~~any~~risks ~~of our product candidates fails in research~~ and ~~development~~uncertainties ~~or clinical trials or does~~ not ~~gain~~presently ~~regulatory~~known ~~approval, or, if approved, fails~~ to ~~achieve~~us ~~market~~or ~~acceptance,~~that we ~~may~~currently ~~never~~deem ~~become~~immaterial ~~profitable.~~also ~~Even if we achieve profitability in the future, we~~ may ~~not~~impair beour ~~able~~business ~~to sustain profitability in subsequent periods~~operations.

Risks Related to Our Financial Condition, Limited Operating History and Need for Additional Capital

We are a late-stage clinical cell therapy company that has incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing net losses for the foreseeable future.

Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to prove safe and effective, gain regulatory approval or become commercially viable. We are a late-stage clinical cell therapy company that does not yet have any products approved by regulatory authorities for sale, and we have incurred significant research, development and other expenses related to our ongoing operations and expect to continue to incur such expenses. Since our inception, we have not generated any revenue from product sales and have incurred significant net losses. Substantially all of our net losses since inception have resulted from our research and development programs and general and administrative costs associated with our operations.

We do not expect to generate revenue from product sales for the foreseeable future, if at all. We also expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate these losses to increase as we continue to research, develop and seek regulatory approvals for our product candidates, expand our manufacturing capabilities, in-license or acquire additional technologies and potentially begin to commercialize product candidates that may achieve regulatory approval. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. Moreover, our net losses may fluctuate significantly from quarter to quarter and year to year, such that a period‑to‑period comparison of our results of operations may not be a good indication of our future performance. If any of our product candidates fails in research and development or clinical trials or does not gain regulatory approval, or, if approved, fails to achieve market acceptance, we may never become profitable. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.

We expect to incur additional expenses and operating losses in the foreseeable future, as we:

•continue nonclinical development of our current and future product candidates and initiate additional nonclinical studies;

•commence and continue clinical trials, including pivotal trials, of our current and future product candidates;

•~~advance~~continue ~~our~~nonclinical ~~genetic~~development ~~and~~of ~~epigenetic~~our ~~reprogramming~~current ~~technologies~~and asfuture ~~well~~product ascandidates ~~other~~and ~~research~~initiate ~~and~~additional ~~development~~nonclinical ~~efforts~~studies;

•advance our other research and development efforts;

•acquire and license technology or technologies;

•attract, hire and retain qualified personnel;

•seek regulatory approval of our current and future product candidates;

•expand our manufacturing and process development capabilities;

•expand our operational, financial and management systems and compliance programs;

•~~acquire~~prepare for future commercialization activities, including marketing, sales and ~~license~~distribution ~~technology~~for orany ~~technology~~of ~~platforms~~our product candidates for which we receive marketing approval;

•integrate ImmPACT and IMPT-314 into our business;

•continue to develop, protect and defend our intellectual property portfolio; and

•incur additional legal, accounting or other expenses in operating our business, including the additional costs associated with operating as a public company and maintaining ~~or regaining~~ compliance with the applicable continued listing requirements of The Nasdaq Global Select Market.

We ~~operate~~will inrequire asubstantial ~~rapidly~~additional ~~evolving~~capital ~~field~~to ~~and~~achieve ~~have~~our goals, and a ~~limited~~failure ~~operating~~to ~~history,~~obtain ~~which~~this ~~may~~necessary ~~make~~capital itwhen ~~difficult~~needed tocould ~~evaluate~~force ~~the~~us ~~success~~to ofdelay, ~~our~~limit, ~~business~~reduce toor ~~date~~terminate ~~and~~our toproduct ~~assess~~development ~~our~~or ~~future~~commercialization ~~viability~~efforts.

We ~~operate~~have inlimited aresources ~~rapidly evolving field~~ and, ~~having~~we ~~commenced~~expect ~~operations~~to inneed ~~June~~to ~~2018,~~expend ~~have~~substantial aresources ~~limited~~for ~~operating~~the ~~history,~~foreseeable ~~which~~future ~~make it difficult~~ to ~~evaluate~~advance ~~our business~~ and ~~prospects.~~expand ~~Our~~our ~~primary~~research ~~activities~~pipeline, toconduct ~~date~~nonclinical ~~have~~studies ~~included~~and pursue clinical development and manufacturing of ~~T‑cell~~our ~~therapies,~~product ~~conducting~~candidates. ~~research~~We ~~and~~also ~~development,~~expect ~~acquiring~~to ~~technology,~~continue ~~entering~~to ~~into~~expend ~~strategic~~resources ~~collaboration~~for ~~and~~the ~~license~~development ~~agreements,~~of ~~enabling~~our ~~and~~technologies. ~~executing~~These ~~manufacturing~~expenditures ~~activities~~will ininclude ~~support~~costs ofassociated ~~our~~with ~~product~~research ~~candidate~~and development ~~efforts~~, ~~executing~~conducting ~~clinical~~nonclinical ~~trials,~~studies ~~organizing~~ and ~~staffing~~clinical ~~the company~~trials, ~~business~~acquiring ~~planning,~~or ~~establishing~~licensing ~~our~~new ~~intellectual~~technologies ~~property portfolio, regulatory submissions~~ and ~~other~~potentially ~~preparations~~obtaining toregulatory ~~initiate~~approvals and ~~execute~~manufacturing ~~clinical trials~~products, ~~raising~~as ~~capital~~well ~~and~~as ~~providing~~marketing ~~general~~ and ~~administrative~~selling ~~support~~products approved for ~~these~~sale, ~~activities~~if any. ~~Any~~We ~~predictions~~will ~~about~~also ~~our~~need ~~future~~to ~~success,~~make ~~performance~~significant orexpenditures ~~viability~~to ~~may~~expand ~~not~~our bemedical asaffairs ~~accurate~~organization asfor ~~they~~medical ~~could~~education beand ifdevelop ~~we had~~ a ~~longer~~commercial ~~operating~~organization ~~history~~capable orof ~~approved~~sales, ~~products~~marketing ~~on the market.~~

In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transition at some point from a company with a research and development focus to a company capable of supporting commercial activities. We may not be successful in such a transition. We expect our financial condition and operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Accordingly, any of our quarterly or annual periods’ results are not indicative of future operating performance.36

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and distribution for products, if any, that we intend to sell ourselves in the markets in which we choose to commercialize. In addition, we may be required to make success payments and other contingent consideration payments under our license, collaboration and other agreements. Because the design and outcome of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the discovery, development and commercialization of our existing and potential product candidates, and other unanticipated costs may arise. Our current resources may be insufficient to support or complete the discovery, development and commercialization of our existing and potential product candidates.

As a result of expense timing, as well as diligent expense management, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to meet our working capital and capital expenditure needs into the second quarter of 2027. However, our future capital requirements and the period for which our existing resources will support our operations may vary significantly from what we expect, and we will in any event require additional capital to complete clinical development of any of our current programs.

We do not have any committed external source of funds. Additional funds may not be available when we need them on terms that are acceptable to us, or at all, and our ability to raise additional capital may be adversely impacted by potentially unfavorable global economic conditions or conditions in the biopharmaceutical industry, including disruptions to, or volatility in, the credit and financial markets in the United States and worldwide, actual or perceived changes in interest rates and economic inflation, the current or anticipated impact of geopolitical instability and otherwise. In February 2024, we entered into a sales agreement with Cowen and Company, LLC (Cowen), acting as our sales agent (the Sales Agreement), pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $150.0 million from time to time in a series of one or more at‑the‑market equity offerings. Neither we nor Cowen are obligated to sell any shares and, as of December 31, 2025, we had not made any sales under the Sales Agreement. In July 2025, we entered into a Securities Purchase Agreement (the SPA) with certain investors pursuant to which we sold and issued shares of our common stock for gross proceeds of approximately $100.0 million in two equal closings in July 2025 and March 2026. If adequate funds are not available to us on a timely basis, including pursuant to the Sales Agreement, we may be required to delay, limit, reduce or terminate nonclinical studies, clinical trials or other development activities for our product candidates or delay, limit, reduce or terminate our establishment of sales, marketing and distribution capabilities or other activities that may be necessary to commercialize our product candidates.

We currently have no products approved for sale and have never generated revenue from product sales. We may never generate revenue from product sales or achieve profitability.

To date, we have not generated any revenues from product sales. Our ability to generate revenues from product sales and achieve profitability will depend on our ability to successfully develop and subsequently obtain regulatory approvals for and commercialize our product candidates. Our ability to generate revenues and achieve profitability also depends on a number of additional factors, including our ability to:

•successfully complete our research activities to identify the technologies and product candidates to further investigate in clinical trials;

•successfully complete development activities, including the necessary clinical trials;

•complete and submit regulatory submissions to the FDA, the European Medicines Agency or other agencies and obtain regulatory approval for indications for which there is a commercial market;

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•obtain coverage and adequate reimbursement from third parties, including government and private payors;

•set commercially viable prices for our products, if any;

•develop manufacturing and distribution processes for our product candidates;

•produce commercial quantities of our products at acceptable cost levels;

•maintain adequate supply of our product candidates, including any starting materials and reagents needed;

•maintain the supply of our product candidates in a manner that is compliant with global legal requirements or to the extent necessary;

•establish and maintain manufacturing relationships with reliable third parties;

•achieve market acceptance of our products, if any;

•attract, hire and retain qualified personnel;

•protect our rights in our intellectual property portfolio;

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•develop a commercial organization capable of sales, marketing and distribution for any products we intend to sell ourselves in the markets in which we choose to commercialize on our own; and

•find suitable distribution partners to help us market, sell and distribute our approved products in other markets.

Our revenues for any product for which regulatory approval is obtained will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the availability of other competing approved or commonly used therapies in the indications for which we are approved, the accepted price for the product, the ability to get reimbursement at any price and whether we own the commercial rights for that territory. In addition, we anticipate incurring significant costs associated with commercializing any approved product. As a result, even if we generate revenue from product sales, we may not become profitable and may need to obtain additional funding to continue operations. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations.

We ~~will~~operate ~~require~~in ~~substantial~~a ~~additional~~rapidly ~~capital~~evolving tofield ~~achieve our goals,~~ and have a ~~failure~~limited tooperating ~~obtain~~history, ~~this~~which ~~necessary~~may ~~capital~~make ~~when~~it ~~needed~~difficult ~~could~~to ~~force~~evaluate usthe tosuccess ~~delay,~~of ~~limit,~~our ~~reduce~~business orto ~~terminate~~date ~~our~~and ~~product~~to ~~development~~assess orour ~~commercialization~~future ~~efforts~~viability.

We ~~expect~~operate toin ~~expend~~a ~~substantial~~rapidly ~~resources~~evolving ~~for~~field ~~the foreseeable future to advance~~ and ~~expand our research pipeline~~, ~~conduct~~having ~~nonclinical~~commenced ~~studies~~operations ~~and~~in ~~pursue~~June ~~clinical~~2018, ~~development~~have ~~and~~a ~~manufacturing~~limited ofoperating ~~our~~history, ~~product~~which ~~candidates.~~makes Weit ~~also~~difficult ~~expect~~ to ~~continue~~evaluate ~~to expend resources for the development of~~ our ~~technology~~business ~~platforms~~and prospects. ~~These~~Our ~~expenditures~~primary ~~will~~activities ~~include~~to ~~costs~~date ~~associated~~have ~~with~~included conducting research and development, ~~acquiring~~regulatory orsubmissions ~~licensing~~and ~~new~~other ~~technologies,~~preparations ~~conducting~~to ~~nonclinical~~initiate ~~studies~~ and execute clinical trials, ~~and~~executing ~~potentially~~clinical ~~obtaining~~trials, ~~regulatory~~enabling ~~approvals~~ and executing manufacturing ~~products,~~activities asin ~~well~~support asof ~~marketing~~our ~~and~~product ~~selling~~candidate ~~products~~development ~~approved~~efforts, ~~for~~acquiring ~~sale~~technology, ifentering ~~any.~~into Westrategic ~~will~~collaboration ~~also~~and ~~need~~license ~~to make significant expenditures to develop a commercial organization capable of sales~~agreements, ~~marketing~~organizing and ~~distribution~~staffing ~~for~~the ~~any products~~company, ifbusiness ~~any~~planning, ~~that~~establishing weand ~~intend~~maintaining ~~to sell ourselves in the markets in which we choose to commercialize. In addition, we may be required to make substantial payments related to~~ our ~~acquisition~~intellectual ofproperty ~~ImmPACT~~portfolio, ~~success~~raising ~~payment~~capital ~~agreements~~ and ~~other~~providing ~~contingent~~general ~~consideration~~and ~~payments~~administrative ~~under~~support ~~our~~for ~~license~~these ~~and collaboration agreements~~activities. ~~Because~~Any ~~the~~predictions ~~design~~about ~~and outcome of~~ our ~~planned~~future ~~and anticipated clinical trials are highly uncertain~~success, weperformance ~~cannot~~or ~~reasonably~~viability ~~estimate~~may ~~the~~not ~~actual~~be ~~amounts~~as ~~necessary~~accurate toas ~~successfully~~they ~~complete~~could ~~the~~be ~~discovery,~~if ~~development~~we ~~and~~had ~~commercialization~~a oflonger ~~our~~operating ~~existing~~history ~~and~~or ~~potential~~approved ~~product~~products ~~candidates,~~on ~~and~~the ~~other unanticipated costs may arise~~market.

AsIn ~~of December 31~~addition, ~~2024,~~ we ~~had~~may ~~approximately~~encounter ~~$383.5 million~~unforeseen inexpenses, ~~cash~~difficulties, ~~cash~~complications, ~~equivalents~~delays and ~~marketable~~other ~~securities.~~known Asand aunknown ~~result~~factors. ofIf ~~expense timing~~successful, aswe ~~well~~will asneed ~~diligent~~to ~~expense~~transition ~~management,~~at wesome ~~believe~~point ~~that~~from ~~our~~a ~~existing~~company ~~cash,~~with ~~cash~~a ~~equivalents~~research and ~~marketable~~development ~~securities~~focus ~~will~~to bea ~~sufficient~~company tocapable ~~meet~~of ~~our~~supporting ~~working~~commercial ~~capital~~activities. ~~and~~We ~~capital~~may ~~expenditure~~not ~~needs~~be ~~into~~successful ~~2027~~in such a transition. ~~However,~~We expect our ~~future~~financial ~~capital~~condition ~~requirements~~ and ~~the~~operating ~~period~~results ~~for~~to ~~which~~continue ~~our~~to ~~existing~~fluctuate ~~resources~~significantly ~~will~~from ~~support~~quarter ~~our~~to ~~operations~~quarter ~~may~~and ~~vary~~year ~~significantly~~to ~~from~~year ~~what~~due weto ~~expect~~a variety of factors, ~~and~~many weof ~~will~~which inare beyond our control. Accordingly, any ~~event~~of ~~require~~our ~~additional~~quarterly ~~capital~~or toannual ~~complete~~periods’ ~~clinical~~results ~~development~~are ofnot ~~any~~indicative of ~~our~~future ~~current~~operating ~~programs~~performance.

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our product candidates or delay, limit, reduce or terminate our establishment of sales, marketing and distribution capabilities or other activities that may be necessary to commercialize our product candidates.

Our milestone, royalty and success payment obligations may result in dilution to our stockholders or may reduce the availability of our cash resources to satisfy the payment obligations, which could cause our operating results and financial condition to fluctuate significantly from quarter to quarter and year to year and may reduce the usefulness of our GAAP consolidated financial statements.

In connection with the Agreement and Plan of Merger, dated as of October 24, 2024, by and among Lyell, ImmPACT, Inspire Merger Sub Inc. and WT Representative LLC, solely in its capacity as the Representative (the Merger Agreement), we agreed to issue additional shares of our common stock upon the achievement of certain IMPT-314 clinical or regulatory milestones and to make certain cash royalty payments to the pre-closing stockholders of ImmPACT based on future annual net sales of IMPT-314 in the United States. In addition, as a result of the acquisition of ImmPACT, we have assumed ImmPACT’s rights and obligations under the UCLA License Agreement, pursuant to which we are obligated to pay a nominal, tiered annual license maintenance fee, one-time milestone payments for each commercialized licensed product and a tiered royalty on worldwide annual net sales of commercialized licensed products. For information related to our milestone and royalty obligations, see Note 3, ~~Acquisition~~Acquisitions, in the accompanying notes to our audited consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10‑K.

~~Additionally~~In addition, ~~we agreed to make success payments payable~~ in ~~cash~~connection orwith ~~publicly-tradeable~~the ~~shares~~ICT ofLicense ~~our~~Agreement, ~~common~~ICT ~~stock~~is ateligible ~~our discretion pursuant~~ to ~~our~~receive ~~success~~additional ~~payment~~cash ~~agreements with Fred Hutch~~ and ~~Stanford,~~equity ~~pursuant to which we may be required to make success~~ payments ~~based on increases in the per share fair value~~ of ~~our~~(i) ~~common~~a ~~stock~~potential on$30 ~~each~~million ~~contractually~~clinical ~~prescribed~~milestone ~~measurement date. Our success~~ payment ~~obligations are recorded as liabilities on our audited consolidated balance sheets. Under U.S. generally accepted accounting principles (GAAP)~~, weup ~~are~~to ~~required~~$115 tomillion ~~estimate~~upon the ~~fair~~achievement ~~value~~ of ~~these~~certain ~~liabilities~~late-stage asregulatory ofmilestones ~~each quarter end~~ and ~~changes~~up ~~in the estimated fair value are accreted~~ to ~~research~~$675 ~~and~~million development expense over the service period of the collaboration agreement. Once the requisite service obligation to earn the potential success payment consideration is met under our continued collaboration agreements, the change in ~~the~~commercial ~~success~~sales ~~payment~~milestones; ~~liabilities~~(ii) ~~fair~~up ~~value is recognized in other income or expense, net. For example, in December 2022, Fred Hutch had provided the requisite service obligation~~ to ~~earn~~an ~~the~~additional potential success payment consideration under the continued collaboration; accordingly in 2023 and future periods, the change in the success payments liability fair value is recognized in other income or expense, net1.85 ~~Factors~~million ~~that~~shares ~~may lead to increases or decreases in the estimated fair value~~ of our ~~success~~common ~~payment~~stock ~~liabilities~~based ~~include,~~on ~~among others, changes in~~ the ~~value~~achievement of ~~the~~certain ~~common~~clinical ~~stock,~~and ~~changes~~regulatory inmilestones; ~~volatility~~ and ~~changes~~(iii) intiered ~~the~~royalties ~~risk-free~~ranging ~~rate.~~from ~~For~~mid-single ~~information~~digits ~~related~~up to ~~our~~10% ~~success~~on ~~payment~~annual ~~obligations,~~net ~~see~~sales ~~Note~~in 4,the ~~License,~~United ~~Collaboration~~States and ~~Success~~low ~~Payment Agreements, in the accompanying notes~~ to ~~our~~mid-single‑digit ~~audited~~royalties ~~consolidated~~on ~~financial~~annual ~~statements~~net ~~included~~sales in ~~Part~~other ~~II,~~countries ~~Item~~within 8the oflicensed ~~this Annual Report on Form 10‑K~~territory.

We also agreed to make success payments payable in cash or publicly-tradeable shares of our common stock at our discretion pursuant to our success payment agreements with Stanford, pursuant to which we may be required to make success payments based on increases in the per share fair value of our common stock on each contractually prescribed measurement date. Our success payment obligations are recorded as liabilities on our consolidated balance sheets. Under U.S. generally accepted accounting principles (GAAP), we are required to estimate the fair value of these liabilities as of each quarter end and changes in the estimated fair value are accreted to research and development expense over the service period of the collaboration agreement. Once the requisite service obligation to earn the potential success payment consideration is met under our continued collaboration agreements, the change in the success payment liabilities fair value is recognized in other income or expense, net. For example, in September 2024, Stanford had provided the requisite service obligation to earn the potential success payment consideration under the continued collaboration; accordingly in future

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periods, the change in the success payments liability fair value is recognized in other income or expense, net. We may have additional obligations owed to third parties in the form of cash or equity. Factors that may lead to increases or decreases in the estimated fair value of our success payment liabilities include, among others, changes in the value of the common stock, changes in volatility and changes in the risk-free rate. For information related to our success payment obligations, see Note 4, License, Collaboration and Success Payment Agreements, in the accompanying notes to our audited consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10‑K.

In order to satisfy our obligations to make these milestone and success payments, if and when they are triggered, we may issue equity or convertible debt securities, as applicable, that may cause dilution to our stockholders. We may also use our existing cash to satisfy the milestone, royalty or success payment obligations, if and as applicable, in the future, which may adversely affect our financial position. As a result, our operating results and financial condition as reported by GAAP may fluctuate significantly from quarter to quarter and from year to year, which may reduce the usefulness of our GAAP consolidated financial statements. In addition, these success, milestone and royalty payments may impede our ability to raise money in future public offerings of debt or equity securities or to obtain a third-party line of credit.

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

Under the Tax Cuts and Jobs Act of 2017 (the Tax Act), as modified by the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act), our net operating losses (NOLs) generated in tax years beginning after December 31, 2017 may be carried forward indefinitely, but the deductibility of such federal NOLs is limited to 80% of taxable income. There is variation in how states have responded and may continue to respond to the Tax Act and CARES Act. In addition, under Sections 382 and 383 of the U.S. Internal Revenue Code of 1986, as amended (the Code), if a corporation undergoes an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period, the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes (such as research and development tax credits) to offset its post-change income or taxes may be limited. We may have experienced ownership changes in the past, including as a result of our initial public offering (IPO), and may experience future ownership changes as a result of subsequent shifts in our stock ownership (some of which may be outside our control). As a result, our ability to use our pre-change NOLs and tax credits to offset post-change taxable income, if any, could be subject to limitations. Similar provisions of state tax law may also apply. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. As a result, even if we attain profitability, we may be unable to use a material portion of our NOLs and tax credits.

We have long-lived assets, which are assessed for impairment whenever events or changes in circumstances indicate that their carrying amount may not be recoverable. In addition, we may never realize the full value of our long‑lived assets, causing us to record material impairment charges.

Under GAAP, we assess our long-lived assets, including property and equipment and lease right-of-use assets, for possible impairment whenever events or circumstances indicate that the carrying amount of such assets may not be recoverable. For example, as a result of the sustained decline in the trading price of our ~~Common~~common ~~Stock~~stock and related market capitalization, our reprioritization of certain research and development programs and our associated reductions in workforce, we performed an impairment assessment of long-lived assets for the year ended December 31, 2024 that resulted in recognition of an impairment of long-lived assets. See Note 5, Impairment of Long-Lived Assets, in the accompanying notes to our audited consolidated financial statements included in Part II, Item 8, of this Annual Report on Form 10-K for additional information.

It is possible that changes in circumstances, many of which are outside of our control, or in the numerous variables associated with the assumptions and estimates used in assessing the appropriate valuation of our long-lived assets, could in the future result in an impairment to our long-lived assets, requiring us to record impairment charges, which would adversely affect our results of operations.

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Risks Related to Our Business and Industry

If we are unable to successfully develop, manufacture and commercialize product candidates or experience significant delays in doing so, our business may be harmed.

We currently have ~~only~~two ~~one~~ product ~~candidate,~~candidates ~~IMPT-314,~~ in ~~Phase 1/2~~ clinical development. WeOur ~~have~~lead ~~not~~product ~~yet~~candidate, ~~demonstrated~~ronde-cel, ~~our~~is ~~ability~~under toevaluation ~~successfully~~in ~~complete~~the ~~any~~pivotal ~~clinical~~PiNACLE ~~trials~~trial ~~(including~~in ~~any~~the ~~pivotal~~3L+ ~~clinical~~setting ~~trials),~~and ~~obtain~~in ~~regulatory approvals, manufacture~~ a ~~commercial‑scale~~Phase ~~product~~1/2 orclinical ~~arrange~~trial ~~for~~in athe ~~third~~2L ~~party~~setting. toA dosecond sopivotal ontrial, ~~our behalf~~PiNACLE-H2H, orwhich ~~conduct~~is ~~sales~~a ~~and~~Phase ~~marketing~~3 ~~activities~~head-to-head ~~necessary~~CAR ~~for~~T‑cell ~~successful~~therapy ~~product~~randomized ~~commercialization.~~controlled ~~For~~trial ~~example, before prioritizing development~~ of ~~our~~ronde-cel ~~IMPT‑314~~for ~~product~~LBCL ~~candidate,~~in ~~our strategy focused on~~ the ~~development~~2L ~~of our LYL797~~setting, ~~LYL845~~had ~~and~~its ~~LYL119~~first ~~clinical~~patient ~~programs,~~dosed ~~which~~in weFebruary ~~discontinued~~2026. ~~following~~LYL273, ~~the~~a ~~acquisition~~novel ~~of IMPT~~GCC-~~314.~~targeted WeCAR ~~have~~T-cell ~~invested substantial resources in developing our technology platforms and our~~ product ~~candidates~~candidate, ~~conducting~~is ~~nonclinical~~under ~~studies,~~evaluation ~~commencing~~in ~~and~~a ~~conducting~~U.S. ~~clinical~~Phase ~~trials~~1 ~~and building our manufacturing facilities and capabilities~~dose-escalation, ~~each~~dose-expansion ofclinical ~~which~~trial ~~will~~in bepatients ~~required~~with ~~prior~~refractory tomCRC. ~~any~~We ~~regulatory~~have ~~approval~~not ~~and~~yet ~~commercialization.~~demonstrated ~~Our~~our ability to ~~generate~~successfully ~~revenue~~complete ~~from~~any ~~product~~clinical ~~sales,~~trials ~~which~~(including weany dopivotal ~~not~~clinical ~~expect will occur for several years~~trials), ifobtain ~~ever,~~regulatory will depend heavily on the successful research and development and eventual commercialization of one or more product candidates in profitable indications and markets. The success of our efforts to identifyapprovals, ~~develop,~~ manufacture ~~and~~a ~~commercialize~~commercial‑scale product ~~candidates~~or ~~will~~arrange ~~depend~~for ona ~~many~~third ~~factors,~~party ~~including~~to ~~the following:~~

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do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization, and we have previously discontinued clinical development for other programs. We have invested substantial resources in developing our technologies and our product candidates, conducting nonclinical studies, commencing and conducting clinical trials and building our manufacturing facilities and capabilities, each of which will be required prior to any regulatory approval and commercialization. Our ability to generate revenue from product sales, which we do not expect will occur for a few years, if ever, will depend heavily on the successful research and development and eventual commercialization of one or more product candidates in profitable indications and markets. The success of our efforts to identify, develop, manufacture and commercialize product candidates will depend on many factors, including the following:

•timely and successful completion of our nonclinical studies and research activities to identify and develop product candidates to investigate in clinical trials;

•submission of INDs to the FDA to proceed with clinical trials, or comparable applications to foreign regulatory authorities that allow the commencement of our planned clinical trials for our product candidates;

•successful enrollment and completion of clinical trials in compliance with GCP requirements with positive results;

•the level of efficacy observed with our product candidates;

•the prevalence and severity of adverse events experienced with ~~any of~~ our product candidates;

•successfully developing, or making arrangements with third parties for, manufacturing and distribution processes for our product candidates and for commercial manufacturing and distribution for any of our product candidates that receive regulatory approval;

•receipt of timely regulatory approvals from applicable authorities for our product candidates for their intended uses;

•protecting our rights in our intellectual property portfolio, including by obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our product candidates;

•establishing capabilities and infrastructure to obtain the materials needed to develop and, if successful, commercialize approved products;

•manufacturing our product candidates at an acceptable cost;

•launching commercial sales of our products, if approved by applicable regulatory authorities, whether alone or in collaboration with others;

•acceptance of our products, if approved by applicable regulatory authorities, by patients and the medical community;

•obtaining and maintaining coverage and adequate reimbursement by third-party payors, including government payors, for our products, if approved by applicable regulatory authorities;

•developments relating to our competitors and our industry, including any existing or future competing product candidates or therapies, and our ability to effectively compete with other marketed therapies;

•~~effectively~~maintaining ~~competing~~compliance with ~~other~~regulatory ~~marketed~~requirements, ~~therapies~~including the U.S and EU cGMP requirements;

•maintaining ~~compliance~~a ~~with~~continued ~~regulatory~~acceptable ~~requirements~~benefit/risk profile of our products following approval, ~~including~~if ~~the~~approved ~~cGMP~~by ~~requirements~~applicable regulatory authorities; and

•maintaining a continued acceptable benefit/risk profile of the products following approval; and

•maintaining and growing an organization of scientists and functional experts who can develop and commercialize our products and technology.

If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully develop and commercialize our product candidates, which could harm our business. If we do not receive marketing approvals for any product candidate we develop, we may not be able to continue our operations.

35Our product candidates and technologies are based on novel technologies that are unproven and may not result in approvable or marketable products, which expose us to unforeseen risks and make it difficult for us to predict the time

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weand docost ~~not~~of ~~receive~~product ~~marketing~~development ~~approvals~~and potential for ~~any~~regulatory ~~product~~approval, ~~candidate~~and we ~~develop, we~~ may not be ~~able~~successful in our efforts to ~~continue~~use and expand our ~~operations~~technologies to develop any product candidate.

~~Our~~We are seeking to identify and develop a pipeline of product candidates ~~and~~using ~~technology~~our ~~platforms~~proprietary ~~are~~technologies. The scientific research that forms the basis of our efforts to develop product candidates with our technologies is still ongoing. Further, the scientific evidence to support the feasibility of developing therapeutic treatments based on ~~novel~~our technologies ~~that~~is both preliminary and limited. Additionally, although ronde‑cel is in the pivotal PiNACLE trial in the 3L+ setting, the PiNACLE-H2H trial in the 2L setting and LYL273 is in Phase 1 clinical development, our current clinical data are ~~unproven~~limited, and nonclinical data may not ~~result~~translate ininto ~~approvable~~humans or ~~marketable~~may ~~products~~not accurately predict the safety and efficacy of our product candidates in humans. As a result, ~~which~~we ~~expose~~are usexposed to a number of unforeseen risks, and ~~make~~ it is difficult ~~for us~~ to predict the ~~time~~types of challenges and ~~cost~~risks that we may encounter during development of our product ~~development~~candidates. Although we have presented clinical data from the PiNACLE trial in the 3L+ setting and ~~potential~~the ~~for~~Phase ~~regulatory~~1/2 ~~approval~~trial of ronde‑cel, including data from patients with relapsed and/or werefractory ~~may~~LBCL, ~~not~~and befrom ~~successful~~the Phase 1 trial of LYL273 in patients with refractory mCRC, our ~~efforts~~clinical totrials ~~use~~may ~~and~~not ~~expand~~generate ~~our~~similar ~~technology~~results ~~platforms~~or otherwise provide adequate data to ~~develop~~demonstrate ~~any~~the efficacy and safety of our product ~~candidate~~candidates.

WeGiven ~~are~~the ~~seeking~~novelty toof ~~identify~~our ~~and~~technologies, ~~develop~~we aintend ~~pipeline~~to ofwork ~~product~~closely ~~candidates~~with ~~using~~the ~~our~~FDA ~~proprietary~~and ~~technology~~comparable ~~platforms.~~foreign ~~The~~regulatory ~~scientific~~authorities ~~research~~to ~~that~~perform ~~forms~~ the ~~basis~~requisite scientific analyses and evaluation of our ~~efforts~~methods to ~~develop~~obtain regulatory approval for our product candidates; however, the regulatory pathway with ~~our~~the ~~technology~~FDA ~~platforms~~and iscomparable ~~still~~foreign ~~ongoing~~regulatory authorities may be more complex and time-consuming relative to other more well-known therapeutics. ~~Further,~~Even ~~the~~if ~~scientific~~we ~~evidence~~obtain human data to support our product candidates, the ~~feasibility~~FDA ofor ~~developing~~comparable ~~therapeutic~~foreign ~~treatments~~regulatory ~~based~~authorities onmay ~~our~~lack ~~technology~~sufficient ~~platforms~~experience isin ~~both~~evaluating ~~preliminary~~the safety and ~~limited.~~efficacy ~~Additionally~~of our product candidates developed using our technologies, ~~although~~which ~~IMPT-314~~could isresult in ~~Phase~~a ~~1/2~~longer ~~clinical~~than ~~development,~~expected ~~our~~regulatory ~~current~~review ~~clinical~~process, ~~data~~increase ~~are~~our ~~limited,~~expected development costs and ~~nonclinical~~delay ~~data~~or ~~from~~prevent ~~murine~~commercialization ~~tumor~~of ~~models~~our ~~and~~product incandidates. ~~vitro~~The ~~experiments~~validation ~~with~~process ~~tumor~~takes ~~cell~~time ~~lines~~and resources, may ~~not~~require ~~translate~~independent ~~into~~third-party ~~humans~~analyses orand may not ~~accurately~~be ~~predict~~accepted ~~the~~or ~~safety~~approved ~~and~~by ~~efficacy~~the ofFDA ~~our~~and ~~product~~comparable ~~candidates~~foreign inregulatory ~~humans~~authorities. AsThere acan ~~result,~~be weno ~~are~~assurance ~~exposed~~as to athe ~~number~~length of ~~unforeseen~~clinical ~~risks~~development, ~~and~~the itnumber isof ~~difficult~~patients tothat ~~predict~~ the ~~types~~FDA ofor ~~challenges~~comparable ~~and~~foreign ~~risks~~regulatory ~~that~~authorities we may ~~encounter~~require ~~during~~to ~~development~~be ofenrolled ~~our~~in ~~product~~clinical ~~candidates.~~trials ~~Although~~to ~~ImmPACT~~establish ~~had~~the ~~licensed~~safety, ~~the~~purity ~~dual‑targeting~~and ~~CD19/CD20~~potency ~~CAR~~of ~~T‑cell~~our product ~~candidate~~candidates ~~(IMPT‑314)~~or ~~from~~the ~~UCLA,~~acceptability ~~which~~to ~~had~~the ~~presented~~FDA ator acomparable ~~conference~~foreign ~~interim~~regulatory ~~Phase~~authorities 1of data generated in 13these ~~patients~~clinical ~~with~~trials ~~relapsed/refractory~~to ~~aggressive~~support ~~NHL~~marketing ~~treated~~approvals. inWe ~~its~~cannot ~~clinical~~be ~~trial,~~certain that our ~~IMPT‑314~~approach ~~Phase~~will ~~1/2~~lead ~~clinical~~to ~~trials~~the ~~may~~development ~~not~~of ~~generate~~approvable ~~similar results~~ or ~~otherwise~~marketable ~~provide~~products, ~~adequate~~alone ~~data~~or toin ~~demonstrate~~combination ~~the~~with ~~efficacy~~other ~~and safety of our product candidate~~therapies.

~~Given~~The ~~the~~results ~~novelty~~ of ~~our technology platforms~~research, wenonclinical ~~intend~~studies toor ~~work~~earlier ~~closely~~clinical ~~with~~trials ~~the~~are ~~FDA~~not ~~and~~necessarily ~~comparable~~predictive ~~foreign~~of ~~regulatory~~future ~~authorities~~results. toIf ~~perform~~clinical ~~the~~trials ~~requisite scientific analyses and evaluation~~ of our ~~methods to obtain regulatory approval for our~~ product candidates; ~~however,~~fail ~~the regulatory pathway with the FDA and comparable foreign regulatory authorities may be more complex and time-consuming relative~~ to ~~other~~produce, ~~more~~or ~~well-known~~continue ~~therapeutics. Even if we obtain human data~~ to ~~support our product candidates~~produce, ~~the~~positive ~~FDA~~results or ~~comparable~~demonstrate ~~foreign~~satisfactory ~~regulatory authorities may lack sufficient experience in evaluating the~~ safety and efficacy ~~of our product candidates developed using our technology platforms~~, ~~which~~at ~~could~~the ~~result~~appropriate indose alevel ~~longer~~or ~~than~~at ~~expected regulatory review process~~all, ~~increase~~we ~~our~~may ~~expected~~incur ~~development~~additional costs ~~and delay~~ or ~~prevent~~experience ~~commercialization~~delays ofin ~~our product candidates. The validation process takes time and resources~~completing, ~~may require independent third-party analyses and may not be accepted~~ or ~~approved~~ultimately ~~by the FDA and comparable foreign regulatory authorities. There can~~ be nounable ~~assurance as~~ to ~~the length of clinical development~~complete, the ~~number~~development ~~of patients that the FDA or comparable foreign regulatory authorities may require to be enrolled in clinical trials to establish the safety, purity~~ and ~~potency~~commercialization of our product candidates ~~or the acceptability to the FDA or comparable foreign regulatory authorities of data generated in these clinical trials to support marketing approvals~~. ~~We cannot be certain that our approach will lead to the development of approvable or marketable products, alone or in combination with other therapies.~~

Success in research, nonclinical studies and early clinical trials does not ensure that later clinical trials will generate similar results and otherwise provide adequate data to demonstrate the efficacy and safety of an investigational product. Clinical trials may show that one or more of our product candidates are not safe or effective, in which event we may need to abandon development of such product candidates. In fact, a number of companies in the biopharmaceutical industry, including those with greater resources and experience than us, have suffered significant setbacks in early- and late-stage clinical trials, even after seeing promising results in earlier nonclinical studies or clinical trials. Thus, even if the results from our initial research, nonclinical activities or early clinical results appear positive, we do not know whether the current pivotal PiNACLE trial in the 3L+ setting, PiNACLE-H2H in the 2L setting or the Phase 1 clinical trial for LYL273 in patients with refractory mCRC or subsequent clinical trials we may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market ronde-cel or LYL273. Although we presented clinical data from the PiNACLE trial and the Phase 1/2 clinical trial for ronde‑cel and the Phase 1 clinical trial for LYL273, such results may not be predictive of future results in our ronde‑cel and LYL273 clinical trials and may change following blinded independent central review of the imaging data.

Moreover, final trial results may not be consistent with interim trial results, and results in one indication may not be predictive of results for the same product candidate in another indication. If later-stage clinical trials do not produce favorable results, our ability to achieve regulatory approval for any of our product candidates may be adversely impacted. Even if we believe that we have adequate data to support an application for regulatory approval to market any of our product candidates, the FDA or other regulatory authorities may not agree and may require that we conduct additional clinical trials. Additionally, even if clinical trials show promising early results, clinical trials of the same product candidate in another indication may fail to show similar results, and market acceptance of our product candidate, if approved, may be limited.

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Clinical development involves a lengthy and expensive process with an uncertain outcome.

We currently have two product candidates in clinical development. Our lead product candidate, ronde‑cel, is in the pivotal PiNACLE trial in the 3L+ setting, and a second pivotal trial, PiNACLE-H2H, which is a Phase 3 head‑to‑head CAR T‑cell therapy randomized controlled trial of ronde‑cel for LBCL in the 2L setting, had its first patient dosed in February 2026. In addition, LYL273, our novel GCC‑targeted CAR T‑cell product candidate for the treatment of mCRC, is currently in Phase 1 clinical development. The risk of failure of our product candidates, or any product candidates we acquire, is high. The clinical trials and manufacturing of our product candidates, or any product candidates we acquire, are, and the manufacturing and marketing of such product candidates, if approved, will be, subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to test and market our product candidates. Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive nonclinical testing and clinical trials that our product candidates are both safe and effective for use in each target indication. In particular, because our product candidates are subject to regulation as biological products, we will need to demonstrate that they are safe, pure and potent for use in their target indications. Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use.

The clinical testing that will be required for any product candidates we choose to advance is expensive and can take many years to complete, and its outcome is inherently uncertain. The FDA may not clear the IND submissions for any planned clinical trials. Even if cleared by the FDA and initiated, we cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. Failure can occur at any time during the clinical trial process. Even if our current and planned clinical trials are completed as planned, we cannot be certain that their results will support the safety and effectiveness of our product candidates for their targeted indications or support continued clinical development of our product candidates. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through nonclinical and clinical trials.

In addition, even if such trials are successfully completed, we cannot guarantee that the FDA or comparable foreign regulatory authorities will interpret the results as we do, and more trials could be required before we submit our product candidates for approval. Moreover, results acceptable to support approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulatory approval in that other jurisdiction. To the extent that the results of the trials are not satisfactory to the FDA or comparable foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our product candidates.

To date, we have not fully enrolled or completed any clinical trials required for the approval of our product candidates. We may experience delays in initiating, enrolling or conducting our current and planned clinical trials, and we do not know whether clinical trials will begin or enroll patients on time, will need to be redesigned, will achieve expected enrollment rates or will be completed on schedule, if at all. Our inability to successfully manufacture cell product candidates for enrolled patients or to obtain sufficient amounts of specific reagents and raw materials to manufacture product candidates in a timely manner or at all could delay or preclude our ability to execute and complete the clinical trials. There can be no assurance that the FDA or comparable foreign regulatory authorities will not put clinical trials of any of our product candidates on clinical hold in the future. Clinical trials can be delayed, suspended or terminated for a variety of reasons, including in connection with:

•inability to generate sufficient nonclinical, toxicology or other in vivo or in vitro data to support the initiation of clinical trials;

•delays in sufficiently developing, characterizing or controlling a manufacturing process suitable for advanced clinical trials;

•delays in reaching agreement with the FDA or other regulatory authorities, including comparable foreign regulatory authorities, as to the design or implementation of our clinical trials;

•obtaining regulatory authorization to commence a clinical trial;

•change in our strategy, such as our prioritization of our ronde-cel and LYL273 product candidates and discontinuation in 2024 of our LYL797, LYL845 and LYL119 programs;

•reaching an agreement on acceptable terms with clinical trial sites or prospective CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different clinical trial sites;

•obtaining IRB approval at each trial site or positive ethics committee opinions;

•recruiting suitable patients to participate in our clinical trials;

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•having patients complete a clinical trial or return for post-treatment follow-up;

•inspections of clinical trial sites or operations by applicable regulatory authorities, or the imposition of a clinical hold;

•clinical sites, CROs or other third parties deviating from trial protocol or dropping out of a trial;

•failure to perform in accordance with applicable regulatory requirements, including the FDA’s and comparable foreign regulatory authorities’ GCP requirements, or other applicable regulatory requirements;

•addressing patient safety concerns that arise during the course of a trial, including occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits;

•adding a sufficient number of clinical trial sites;

•manufacturing sufficient quantities of product candidates for use in clinical trials; or

•suspensions or terminations by IRBs or ethics committees of the institutions at which such trials are being conducted, by the independent Data Safety Monitoring Committee for such trial or by the FDA or other regulatory authorities, including comparable foreign regulatory authorities, due to a number of factors, including those described above.

Further, a clinical trial may be suspended or terminated by us, the IRBs or ethics committees for the institutions in which such trials are being conducted, recommended for suspension or termination by the independent Data Safety Monitoring Committee for such trial or suspended or terminated by the FDA or other regulatory authorities, including comparable foreign regulatory authorities, due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities, including comparable foreign regulatory authorities, resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

We cannot predict with any certainty whether or when we might complete a given clinical trial, if at all. If we experience delays or quality issues in the conduct, completion or termination of any clinical trial of our product candidates, the approval and commercial prospects of such product candidate will be harmed, and our ability to generate product revenues from such product candidate will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval process and jeopardize our ability to commence product sales and generate revenues. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may ultimately lead to the denial of regulatory approval of our product candidates.

Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following any regulatory approval. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.

Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authority. As a result of safety or toxicity issues that we may experience in our clinical trials, we may not continue the development of nor receive approval to market any product candidates, which could prevent us from ever generating product revenues or achieving profitability. Previous clinical trials utilizing CAR T cells to treat hematologic malignancies have shown an increased risk of CRS and ICANS, and approved CAR T-cell therapy products carry a boxed warning concerning the risk of developing secondary T‑cell malignancies. For example, while we observed a manageable safety profile appropriate for outpatient administration, initial data from patients with LBCL treated in the 3L+ setting and the 2L setting in our ongoing multi-cohort, multi-center Phase 1/2 clinical trial of ronde-cel reported low rates of Grade > 3 ICANS. In addition to CRS and ICANS, diarrhea or colitis have been reported with LYL273. Adverse events may also be associated with the lymphodepletion utilized with cell therapies. If additional adverse events or other side effects are observed in any of our clinical trials that are atypical of, or more severe than, the known side effects of similar cell therapies, we may have difficulty recruiting patients to our clinical trials, patients may drop out of our trials or we may be required to abandon those trials or our development efforts of one or more product candidates altogether. If such effects are more severe, less reversible than we expect or not reversible at all, we may decide or be required to perform additional studies or to halt or delay further clinical development of any of our product candidates, which could result in the delay or denial of regulatory approval by the FDA or other regulatory authorities.

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In the event that any of our product candidates receives regulatory approval and we or others later identify undesirable or unacceptable side effects caused by such products, a number of potentially significant negative consequences could result, including:

•regulatory authorities may withdraw or limit approvals of such products and require us to take our approved product off the market;

•regulatory authorities may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies, or issue other communications containing warnings or other safety information about the product;

•regulatory authorities may require a medication guide outlining the risks of such side effects for distribution to patients, or that we implement a risk evaluation and mitigation strategy (REMS) plan or risk management plan to ensure that the benefits of the product outweigh its risks;

•we may be required to change the dose or the way the product is administered, conduct additional clinical trials or change the labeling of the product;

•we may be subject to limitations on how we may promote or manufacture the product;

•sales of the product may decrease significantly;

•we may be subject to litigation or product liability claims; and

•our reputation may suffer.

Any of these events could prevent us or our potential future partners from achieving or maintaining market acceptance of the affected product or could substantially increase commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenue from the sale of any products.

Interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as we make changes to our manufacturing processes and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may publicly disclose interim, topline or preliminary data from our nonclinical studies and clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial, or following, for example, independent blinded central review of imaging data. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. Further, modifications or improvements to our manufacturing processes for a therapy may result in changes to the characteristics or behavior of the product candidate that could cause our product candidates to perform differently and affect the results of our ongoing clinical trials. As a result, the topline results that we report may differ from future results of the same studies or clinical trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available.

From time to time, we may also disclose preliminary or interim data from our nonclinical studies and from our or related third-party clinical trials. Preliminary or interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. For example, although we presented clinical data from the PiNACLE trial and the Phase 1/2 trial of ronde‑cel, including data from patients with relapsed and/or refractory LBCL, our ronde‑cel clinical trials, including the pivotal PiNACLE trial and the PiNACLE-H2H trial, may not generate similar results or otherwise provide adequate data to demonstrate the efficacy and safety of ronde-cel. In addition, the enrollment of additional patients into the ongoing U.S. Phase 1 clinical trial of LYL273 in patients with refractory mCRC may not generate similar results or otherwise provide adequate data to demonstrate the safety and efficacy of LYL273. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects. Additionally, disclosure of preliminary or interim data by us or by our competitors could result in volatility in the price of our common stock.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate and our company in general. If the interim, topline or preliminary data we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, any of

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our potential product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

We acquired ImmPACT in October 2024 and LYL273 in November 2025 and may not realize the benefits of such acquisitions or any potential future collaborations, licenses, product acquisitions or other strategic transactions.

We acquired ImmPACT in October 2024 and an exclusive global license, outside of mainland China, Hong Kong, Macau and Taiwan, for LYL273 in November 2025 with the expectation that these acquisitions will result in various benefits including, among other things, benefits relating to a strengthened market position for Lyell, cost savings and operating efficiencies. Our ability to realize the anticipated benefits of these acquisitions is dependent, in part, on our ability to realize the anticipated cost savings, such as those from the transition of the manufacturing of ronde‑cel and LYL273 to LyFE. We may also encounter difficulties that could adversely affect our ability to maintain relationships with existing partners and employees, such as:

•the loss of key employees, including our manufacturing personnel, and associated costs;

•the disruption of operations and business;

•inability to maintain and increase competitive presence;

•possible inconsistencies in standards, control procedures and policies;

•inability to complete trials in a manner previously planned or announced (or continue to demonstrate adequate efficacy and safety);

•additional costs or unexpected problems with manufacturing ronde‑cel and LYL273 at LyFE, executing clinical trials, loss of key personnel or with the licensed technology; and/or

•potential unknown liabilities associated with the ImmPACT and LYL273 acquisitions.

Failure to achieve these anticipated benefits on the anticipated timeframe, or at all, including successfully manufacturing ronde‑cel and LYL273 at LyFE, could result in a reduction in the market price of our securities as well as in increased costs, decreases in the amount of expected revenues and diversion of management’s time and energy and could materially and adversely affect our business, financial condition and operating results. Additionally, we have made fair value estimates of certain assets and liabilities in recording the ImmPACT acquisition and the exclusive license with ICT. Actual values of these assets and liabilities could differ from our estimates, which could result in our not achieving the anticipated benefits of the acquisition. ImmPACT may have liabilities that we failed or were unable to discover in the course of performing due diligence investigations, or we may not have correctly assessed the significance of certain liabilities of ImmPACT identified in the course of our due diligence. Any such liabilities, individually or in the aggregate, could have an adverse effect on our business, financial condition and results of operations. Finally, any cost savings that are realized may be offset by losses in revenues or other charges to earnings.

We may also desire to enter into future collaborations, licenses or other strategic transactions for the acquisition of products or business opportunities, where we believe such arrangement will complement or augment our existing business. These relationships or transactions, or those like them, may require us to incur nonrecurring and other charges, increase our near- and long-term expenditures, issue securities that dilute our existing stockholders, reduce the potential profitability of the products that are the subject of the relationship or disrupt our management and business. In addition, we face significant competition in seeking appropriate strategic alliances and transactions and the negotiation process is time-consuming and complex, and there can be no assurance that we can enter into any of these transactions even if we desire to do so. Moreover, we may not be successful in our efforts to establish a strategic alliance or other alternative arrangements for any future product candidates and programs because our research and development pipeline may be insufficient, our product candidates or programs may be deemed to be at too early a stage of development for collaborative effort and third parties may not view our product candidates and programs as having the requisite potential to demonstrate a positive benefit/risk profile. Any delays in entering into new strategic alliance agreements related to our product candidates could also delay the development and commercialization of our product candidates and reduce their competitiveness even if they reach the market.

If we license products or acquire businesses, we may not be able to realize the benefit of these transactions if we are unable to successfully integrate them with our existing operations and company culture. There are other risks and uncertainties involved in these transactions, including unanticipated liabilities related to acquired intellectual property rights, products or companies and disruption in our relationship with collaborators or suppliers as a result of such a transaction. We cannot be certain that, following an acquisition or license, we will achieve the financial or strategic results that would justify the transaction.

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We face substantial competition in a rapidly changing industry, which may result in others discovering, developing or commercializing products before or more successfully than we do.

The biopharmaceutical industry is highly competitive and subject to significant and rapid technological change. Our success is substantially dependent on our ability to discover, develop and obtain marketing approval for new and innovative products on a cost-effective basis and to market them successfully. We face and will continue to face competition from numerous biopharmaceutical enterprises, as well as from academic institutions, government agencies and private and public research institutions, many of whom have market presence, engineering, technical and marketing capabilities and financial, personnel and other resources substantially greater than ours. These organizations may conduct similar research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and marketing of products that compete with our product candidates. Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Mergers and acquisitions in the biopharmaceutical industry may result in even more resources, including intellectual property that may be necessary or useful for the development and commercialization of our product candidates, being concentrated in our competitors and becoming unavailable to us on commercially reasonable terms or at all. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in this industry.

There are currently a number of companies developing or commercializing autologous and allogeneic CAR T-cell therapies, as well as bi- and tri-specific T-cell engager and other approaches to treat hematologic malignancies and solid tumors. Some of the approved or commonly used drugs and therapies for our current or future target diseases, including LBCL and colorectal cancer, are established and are widely accepted by physicians and patients. Insurers and other third–party payors may encourage the use of these products, and some patients may receive commercially available liso‑cel or axi‑cel rather than enrolling into PiNACLE-H2H, our Phase 3 head-to-head CAR T-cell therapy randomized controlled trial in the 2L setting. Physicians, hospitals and third-party payors often are slow to adopt new products, technologies and treatment practices that require additional upfront costs and training. Physicians may not be willing to undergo training to adopt our novel therapy, may decide the therapy is too complex to adopt without appropriate training or not cost-efficient and may choose not to administer the therapy. Based on these and other factors, hospitals and payors may decide that the benefits of this new therapy do not or will not outweigh its costs and choose other drugs or therapies.

Our product candidates, if approved, may be priced at a significant premium over competitive products. Absent differentiated and compelling clinical evidence, pricing premiums may impede the adoption of our products over currently approved or commonly used therapies, which may adversely impact our business. In addition, many companies are developing new therapeutics, and we cannot predict what the standard of care will become as our product candidates continue in clinical development.

Our ability to enroll clinical trials and/or our commercial opportunities will be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer side effects or are less expensive than any products that we may develop. Additionally, our commercial opportunities will be reduced or eliminated if novel upstream products or changes in treatment protocols reduce the overall incidence or prevalence of our current or future target diseases. Competition could result in reduced sales and pricing pressure on our product candidates, if approved by applicable regulatory authorities. In addition, significant delays in the development of our product candidates could allow our competitors to bring products to market before us and impair any ability to commercialize our product candidates. In addition, our potential future collaborators may decide to market and sell products that compete with the product candidates that we have agreed to license to them, which could have a material adverse effect on our future business, financial condition and results of operations.

We are highly dependent on our key personnel and, if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

Our ability to compete in the highly competitive ~~biotechnology~~biopharmaceutical ~~and~~industry ~~pharmaceutical industries~~ depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel. We are highly dependent on our management, manufacturing, scientific and medical personnel. The loss of the services of any of our executive officers, other key employees, including our highly skilled and trained personnel at our manufacturing facilities, and other scientific and medical advisors and our inability to find suitable replacements could result in delays in product development and harm our business. We conduct substantially all of our operations at our facilities in the San Francisco, Seattle, ~~Bothell~~ and ~~Los~~Bothell ~~Angeles~~ metropolitan areas. These regions are headquarters to many other biopharmaceutical companies and many academic and research institutions. Competition for skilled personnel in these markets is intense and may limit our ability to hire and retain highly qualified personnel on acceptable terms or at all.

To induce valuable employees to remain at our company, in addition to salary and cash incentives, we have provided equity awards that vest over time and, for certain key employees, equity awards that vest subject to certain performance conditions. The value to employees of equity incentives may be significantly affected by factors beyond our control, including market conditions and volatility, and may at any time be insufficient to counteract more lucrative offers from other companies. Because the trading price of our common stock was significantly below the exercise price for many of the options we had granted to our employees, which made the value of our equity as a retention tool decrease substantially, our Board of Directors authorized a repricing of the exercise price of such options for certain employees in November 2023.

Despite our efforts to retain valuable employees, we may nevertheless experience attrition from members of our management, scientific and development teams. For example, there have been departures of executive officers in the past. Although we have employment agreements with our key employees, these employment agreements provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice. We 46

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doperformance ~~not~~conditions. ~~maintain~~The ~~“key~~value ~~man”~~to ~~insurance~~employees ~~policies~~of onequity ~~the~~incentives ~~lives~~may ofbe ~~these~~significantly ~~individuals~~affected orby ~~the~~factors ~~lives~~beyond ofour control, including market conditions and volatility, and may at any oftime ~~our~~be insufficient to counteract more lucrative offers from other ~~employees~~companies. ~~Our~~Because ~~success~~the ~~also~~trading ~~depends~~price onof our ~~ability~~common tostock ~~continue~~was tosignificantly ~~attract,~~below ~~retain~~the ~~and~~exercise ~~motivate~~price ~~highly~~for ~~skilled~~many ~~junior~~of the options we had granted to our employees, ~~mid-level~~which ~~and~~made ~~senior~~the ~~managers~~value asof ~~well~~our equity as ~~junior~~a retention tool decrease substantially, ~~mid-level~~our ~~and~~Board ~~senior~~of ~~scientific~~Directors authorized a repricing of the exercise price of such options for certain employees in November 2023 and ~~medical~~additional ~~personnel.~~equity awards for certain employees in October 2025.

~~Additionally~~Despite our efforts to retain valuable employees, we ~~implemented~~may ~~reductions~~nevertheless inexperience ~~workforce~~attrition infrom ~~the~~members ~~fourth~~of ~~quarters~~our ofmanagement, ~~2023~~scientific and ~~2024~~development ~~and~~teams. ~~the~~Although ~~first~~we ~~quarter~~have ofemployment ~~2025,~~agreements ~~respectively.~~with ~~These~~our ~~reductions~~key inemployees, ~~workforce~~these ~~may~~employment ~~yield~~agreements ~~unintended~~provide ~~consequences~~for ~~and~~at-will ~~costs~~employment, ~~such~~which asmeans ~~difficulty~~that ~~retaining~~any ~~and~~of ~~motivating~~our ~~remaining~~ employees, ~~increased~~could ~~difficulty~~leave in our ~~day-to-day~~employment ~~operations~~at ~~and~~any ~~loss~~time, ofwith ~~institutional~~or ~~knowledge~~without ~~and~~notice. ~~expertise~~We ~~and~~do ~~difficulty~~not inmaintain ~~attracting~~“key ~~and~~man” ~~hiring~~insurance ~~qualified~~policies ~~employees~~on in the ~~future.~~lives Weof ~~may~~these ~~also~~individuals beor ~~subject~~the tolives ~~reputational~~of ~~risks~~any ~~and~~of ~~litigation~~our ~~risks~~other ~~and~~employees. ~~expenses~~Our ~~and~~success ~~may~~also ~~not~~depends ~~realize~~on ~~the~~our ~~savings~~ability orto ~~operational~~continue ~~efficiencies~~to ~~anticipated~~attract, ~~which~~retain ~~could~~and ~~result~~motivate inhighly ~~total~~skilled ~~costs~~junior, mid-level and ~~expenses~~senior ~~that~~managers ~~are~~as ~~greater~~well ~~than~~as ~~expected~~junior, mid-level and senior scientific and medical personnel.

Additionally, we implemented reductions in workforce in the fourth quarters of 2023 and 2024 and the first quarter of 2025. If we ~~cannot~~implement ~~maintain~~additional ~~our~~reductions ~~company~~in ~~culture~~force in the future, these reductions may yield unintended consequences and costs, such as wedifficulty ~~grow~~retaining and motivating remaining employees, increased difficulty in our ~~success~~day-to-day operations and ~~our~~loss ~~business~~of institutional knowledge and expertise and difficulty in attracting and hiring qualified employees in the future. We may also be ~~harmed~~subject to reputational risks and litigation risks and expenses and may not realize the savings or operational efficiencies anticipated, which could result in total costs and expenses that are greater than expected.

We ~~believe~~may ~~our~~expend ~~culture has been a key contributor to~~ our ~~successes~~limited toresources ~~date. Any failure~~ to ~~preserve~~pursue ~~our~~a ~~culture~~particular ~~could~~product ~~negatively~~candidate ~~affect~~or ~~our~~indication ~~ability to retain~~ and ~~recruit~~fail ~~personnel, which is critical~~ to ~~our~~capitalize ~~growth, and to effectively focus~~ on ~~and~~product ~~pursue~~candidates ~~our~~or ~~objectives.~~indications ~~Prior~~that ~~reductions in workforce~~ may ~~adversely impact our culture. Alternatively, as the organization again starts to grow, such as would~~ be ~~expected to support commercialization, and we are required to implement~~ more ~~complex~~profitable ~~organizational~~or ~~management~~for ~~structures,~~which wethere ~~may~~is ~~find~~a itgreater ~~increasingly~~likelihood ~~difficult to maintain the beneficial aspects~~ of ~~our culture~~success. ~~If we fail to maintain our company culture, our business may be adversely affected.~~

~~Any~~Because ~~litigation~~we have limited financial and management resources, we have chosen to prioritize our pipeline to focus on our most differentiated product candidates. As such, we are currently primarily focused on the clinical development of ronde-cel and LYL273 and nonclinical research into novel CAR T-cell product candidates with new targets that are fully-armed with multiple technologies, each designed to address different barriers to effective cell therapies, including T-cell exhaustion, lack of durable stemness, as well as immune suppression within the hostile tumor microenvironment. As a result, we may forego or ~~adversarial~~delay ~~proceedings~~pursuit ~~could~~of beopportunities ~~costly~~with other product candidates or for other indications for these product candidates that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and ~~time~~future development programs and product candidates for specific indications may not yield any commercially‑viable products. For example, we discontinued the development of LYL797, LYL845 and LYL119 in 2024 following the acquisition of ronde-~~consuming~~cel. Further, if we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to ~~defend~~that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.

WeAdditionally, ~~have~~in ~~been~~connection ~~and~~with ~~may~~our indiscontinuation ~~the~~of ~~future~~LYL797, ~~become~~LYL845 ~~subject~~and toLYL119 ~~legal~~in ~~proceedings~~2024, ~~and~~we ~~claims~~incurred ~~that~~costs ~~arise~~associated inwith ~~the~~termination ~~ordinary~~of ~~course~~agreements ofassociated ~~business,~~with ~~such~~these asprograms, ~~claims~~including ~~brought~~winding bydown usour oragreements with third-party ~~parties~~providers inand ~~connection~~CROs ~~with~~conducting ~~commercial~~our ~~disputes~~clinical ortrials. ~~employment~~Termination ~~claims~~of ~~made~~these byagreements ~~our~~may ~~current~~result orin ~~former~~disputes ~~employees.~~with ~~Litigation~~these orservice ~~adversarial~~providers ~~proceedings~~that ~~might~~may result in ~~substantial~~additional costs and ~~may~~liabilities and divert management’s attention and resources, which ~~might~~could ~~seriously~~ harm our business, reputation, overall financial condition and operating results. For example, in February 2021, we filed a demand for arbitration seeking, among other things, rescission of each of the joint-development agreement and stock purchase agreement we entered with PACT Pharma, Inc. (PACT) and recovery of the consideration paid thereunder and in October 2022, we entered into a settlement agreement with PACT to resolve the outstanding legal dispute. Insurance might not cover such claims, might not provide sufficient payments to cover all the costs to resolve one or more such claims and might not continue to be available on terms acceptable to us. Any claim brought by us or against us that is uninsured or underinsured could result in unanticipated costs, thereby harming our business.

We currently have no marketing, sales or distribution infrastructure, and we intend to either establish a sales and marketing infrastructure or outsource this function to a third party. Either of these commercialization strategies carries substantial risks to us.

We currently have no marketing, sales ~~and~~or distribution capabilities. To support commercial marketing and distribution of any of our product candidates that ~~complete clinical development and~~ are approved, we would either establish a sales and marketing organization with technical expertise and supporting distribution capabilities to commercialize our product candidates in a legally compliant manner or outsource this function to a third ~~party~~parties. There are risks involved if we decide to establish our own sales and marketing capabilities or enter into arrangements with third parties to perform these services. To the extent that we enter into collaboration agreements with respect to marketing, sales or distribution, our product revenue may be lower than if we directly marketed or sold any approved products. Such collaborative arrangements with partners may place the commercialization of our products outside of our control and would make us subject to a number of risks, including that we may not be able to control the amount, quality or timing of resources that our collaborative partner devotes to our products or that our collaborator’s willingness or ability to complete its obligations, and our obligations ~~under our arrangements may be adversely affected by business combinations or significant changes in our collaborator’s business strategy.~~

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under our arrangements may be adversely affected by business combinations or significant changes in our collaborator’s business strategy.

If we are unable to enter into these arrangements on acceptable terms or at all, we may not be able to successfully commercialize any approved products. If we are not successful in commercializing any approved products, either on our own or through collaborations with one or more third parties, our future product revenue will suffer, and we may incur significant additional losses, which would have a material adverse effect on our business, financial condition and results of operations.

~~Unstable~~If ~~market~~our ~~and~~information ~~economic~~technology ~~conditions~~systems ~~may~~or ~~have~~those ~~serious~~of third parties with whom we work, or our data, are or were compromised, we could experience adverse consequences onresulting from such compromise, including but not limited to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, ~~financial~~reputational ~~condition~~harm and ~~stock~~other ~~price~~adverse consequences.

~~The~~We ~~global~~and ~~credit~~the third parties with whom we work face a variety of evolving threats that could cause security incidents, including but not limited to social-engineering attacks (including through deep fakes, which are increasingly more difficult to identify as fake, and ~~financial~~phishing ~~markets~~attacks), ~~have~~malicious ~~experienced~~code ~~extreme~~(such ~~volatility~~as viruses and ~~disruptions~~worms), malware (including as a result of ~~actual~~advanced persistent threat intrusions), denial-of-service attacks, credential stuffing, credential harvesting, personnel misconduct or ~~perceived~~error, ~~changes~~ransomware inattacks, ~~interest~~supply-chain ~~rates~~attacks, ~~and~~software ~~economic~~bugs, ~~inflation~~server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, attacks enhanced or facilitated by artificial intelligence (AI), ~~which~~natural ~~included~~disasters, ~~severely~~fire, ~~diminished~~terrorism, ~~liquidity~~war, telecommunication and ~~credit~~electrical failures and other similar threats. Cyber-attacks, malicious internet-based activity, online and offline fraud and other similar activities threaten the confidentiality, integrity and availability of our sensitive data and information technology systems and those of the third parties upon which we rely. Such threats are prevalent and continue to rise, ~~declines~~are increasingly difficult to detect and come from a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,” organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation states and nation-state-supported actors. In particular, severe ransomware attacks are becoming increasingly prevalent and can lead to significant interruptions in ~~consumer~~our ~~confidence~~operations, ~~slower~~ability ~~economic~~to ~~growth~~advance our programs, ~~high~~loss ~~inflation~~of sensitive data, ~~uncertainty~~reputational ~~about~~harm ~~economic~~and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments. To the extent that any disruption or security breach results in a loss of or damage to our data or applications or inappropriate disclosure of confidential or proprietary information, we could incur liability, the further development of our product candidates could be delayed and our business could be otherwise adversely affected. It may be difficult and/or costly to detect, investigate, mitigate, contain and remediate a security incident. Threat actors may also gain access to other networks and systems after a compromise of our networks and systems. Furthermore, in connection with our acquisition of ImmPACT, we integrated their information technology systems with ours. Any disruptions to our operations or other similar challenges due to this or other reasons may increase our vulnerability to cybersecurity threats.

37Our reliance on third parties could introduce new cybersecurity risks and vulnerabilities, including supply-chain attacks, and other threats to our business operations. We rely on third-party service providers and technologies to operate critical business systems and to process sensitive data in a variety of contexts, including, without limitation, cloud-based infrastructure, data center facilities, encryption and authentication technology, employee email, clinical research and development and other functions. We also rely on third-party service providers to provide other products, services or otherwise to operate our business. Our ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place. If our third-party service providers experience a security incident or other interruption, we could experience material adverse consequences. While we may be entitled to damages if our third-party service providers fail to satisfy their data privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be unable to recover such award. In addition, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties’ infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised.

While we have implemented security measures designed to protect against security incidents, we cannot ensure that our data protection efforts and our investment in information technology will detect all vulnerabilities on a timely basis, prevent significant breakdowns, data leakages, breaches in our systems or other cyber incidents that could have a material adverse effect upon our reputation, business, operations or financial condition. For example, we have been the target of unsuccessful phishing attempts in the past and expect such attempts will continue in the future. If any of the events referenced were to occur and cause interruptions in our operations, it could result in a material disruption of our programs, and the development of our product candidates could be delayed. In addition, the loss of clinical trial data for our product candidates could result in delays in our marketing approval efforts and significantly increase our costs to recover or reproduce the data. Furthermore, significant disruptions of our internal information technology systems or security breaches could result in the loss, misappropriation and/or unauthorized access, use or disclosure of, or the prevention of access to, confidential information (including trade secrets or other intellectual property, proprietary business information

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~~stability~~ and ~~swings~~personal ~~in unemployment rates. The financial markets and the global economy may also be adversely affected by the impact of supply chain disruptions~~data), ~~labor~~which ~~shortages,~~could ~~fluctuations~~result in ~~currency exchange rates~~financial, ~~changes in interest rates~~legal, ~~military~~business ~~conflict,~~and ~~acts~~reputational ofharm ~~terrorism~~to ~~or other geopolitical events~~us. ~~Sanctions~~For ~~imposed~~example, ~~and~~any ~~other~~such ~~actions~~event ~~taken,~~that byleads ~~the~~to ~~United~~unauthorized ~~States~~access, ~~and~~use ~~other~~or ~~countries~~disclosure inof ~~response~~personal ~~to geopolitical conflicts~~data, including ~~the~~personal ~~one~~data inregarding ~~Ukraine,~~our ~~may~~clinical ~~also~~trial ~~continue~~patients toor ~~adversely~~employees, ~~impact~~could ~~the~~harm ~~financial~~our ~~markets~~reputation ~~and the global economy~~directly, ~~and~~compel ~~any~~us ~~economic~~to ~~countermeasures~~comply bywith ~~the~~potentially ~~affected~~costly ~~countries~~federal and/or ~~others~~state ~~could~~breach ~~exacerbate~~notification ~~market~~laws and ~~economic~~foreign ~~instability.~~law ~~There~~equivalents, ~~can~~subject beus noto ~~assurance~~mandatory ~~that~~corrective aaction, ~~deterioration~~including inexpending ~~credit~~significant ~~and~~resources ~~financial~~or ~~markets~~modifying ~~and~~our ~~confidence in economic conditions will not occur. Our general~~ business ~~strategy~~practices ~~may~~such beas ~~adversely~~our ~~affected~~clinical bytrial ~~any such economic downturn~~activities, ~~volatile business environment or continued unpredictable~~ and ~~unstable~~otherwise ~~market~~subject ~~conditions,~~us ~~including disruption~~ to ~~enrollment~~liability ~~within~~under ~~our~~laws ~~ongoing trials~~ and ~~our~~regulations ~~ability~~that toprotect ~~purchase necessary supplies on acceptable terms, if at all. If~~ the ~~current~~privacy ~~equity~~ and ~~credit~~security ~~markets~~of ~~deteriorate~~personal data, itwhich ~~may~~could ~~make~~result ~~any~~in ~~necessary~~significant ~~debt~~legal ~~or equity financing more difficult, more costly~~ and ~~more~~financial ~~dilutive.~~exposure ~~Failure to secure any necessary financing in a timely manner~~ and onreputational ~~favorable~~damages ~~terms~~that could potentially have aan ~~material~~ adverse effect on our ~~growth~~business. ~~strategy,~~We ~~financial~~take ~~performance~~steps ~~and~~designed ~~stock~~to ~~price~~detect, mitigate and ~~could~~remediate ~~require~~vulnerabilities usin toour ~~delay~~information ~~or abandon clinical development plans~~systems. ~~In addition~~However, ~~there~~we ismay anot ~~risk~~detect ~~that~~and ~~one~~remediate orall ~~more~~such ofvulnerabilities, ~~our~~including ~~current~~on ~~service~~a ~~providers,~~timely ~~manufacturers~~basis. ~~and~~Further, ~~other~~we ~~partners~~have and may ~~not~~in ~~survive~~the anfuture ~~economic~~experience ~~downturn,~~delays ~~which~~in ~~could~~developing ~~directly~~and ~~affect~~deploying ~~our~~remedial ~~ability~~measures toand ~~attain~~patches ~~our~~designed ~~operating~~to ~~goals~~address onidentified ~~schedule and on budget~~vulnerabilities.

~~The~~Any ~~U.S.~~of ~~government~~the ~~has~~previously ~~indicated~~identified ~~its~~or ~~intent~~similar tothreats ~~alter~~may ~~its~~cause ~~approach~~a tosecurity ~~international~~incident ~~trade~~or ~~policy~~other ~~and~~interruption inthat ~~some~~may ~~cases~~result toin ~~renegotiate~~unauthorized, unlawful or ~~potentially~~accidental ~~terminate~~acquisition, ~~certain~~modification, ~~existing bilateral or multi-lateral trade agreements and treaties with foreign countries. In addition~~destruction, ~~the U.S. government has initiated or is considering imposing tariffs on certain foreign goods. Related to this action~~loss, ~~certain foreign governments~~alteration, ~~including China~~encryption, ~~have~~disclosure ~~instituted~~of or ~~are~~access ~~considering~~to ~~imposing~~our ~~tariffs~~sensitive oninformation ~~certain~~or ~~U.S.~~our ~~goods.~~information Ittechnology ~~remains~~systems, ~~unclear what the U.S. administration~~ or ~~foreign~~those ~~governments~~of ~~will~~the orthird ~~will~~parties ~~not do~~ with ~~respect~~whom towe ~~tariffs or other international trade agreements and policies~~work. AWe ~~trade~~may ~~war~~need ~~or other governmental action related~~ to ~~tariffs~~expend orsignificant ~~international~~resources ~~trade agreements~~ or ~~policies~~modify ~~has the potential to disrupt~~ our ~~research~~business activities, ~~affect~~(including our ~~suppliers~~clinical ~~and/or~~trial ~~the~~activities) ~~United~~to ~~States~~try orto ~~global~~protect ~~economy~~against orany ~~certain~~security ~~sectors thereof and, thus, could adversely impact our businesses~~incidents.

~~Adverse~~Additionally, ~~developments~~certain ~~affecting~~data ~~the~~privacy ~~financial~~and ~~services~~security obligations require us, or we may voluntarily choose, to implement and maintain specific security measures or industry-standard ~~could~~or ~~adversely~~reasonable ~~affect~~security measures to protect our ~~current~~information technology systems and ~~projected~~sensitive ~~business~~data ~~operations~~or ~~and~~to ~~our~~notify ~~financial~~relevant ~~condition~~stakeholders, including affected individuals, regulators and ~~results~~investors, of ~~operations~~security incidents. Such disclosures are costly, and the disclosure or the failure to comply with such requirements could lead to adverse consequences.

~~Adverse~~Our ~~developments~~contracts ~~that~~may ~~affect~~not ~~financial~~contain ~~institutions,~~limitations ~~such~~of ~~as events involving liquidity that are rumored or actual~~liability, ~~have in the past~~ and ~~may~~even inwhere ~~the~~they ~~future lead to bank failures and market-wide liquidity problems. For example~~do, inthere ~~March~~can ~~2023,~~be ~~Silicon~~no ~~Valley~~assurance ~~Bank~~that ~~(SVB)~~limitations ~~was closed by the California Department~~ of ~~Financial~~liability ~~Protection and Innovation, which appointed the Federal Deposit Insurance Corporation (FDIC) as receiver. Similarly, later~~ in ~~March~~our ~~2023,~~contracts ~~Signature~~are ~~Bank~~sufficient ~~and~~to ~~Silvergate~~protect ~~Capital~~us ~~Corp.~~from ~~were each swept into receivership. In addition~~liabilities, ondamages ~~May~~or 1,claims ~~2023,~~related ~~the~~to ~~FDIC~~our ~~seized~~data ~~First~~privacy ~~Republic Bank~~ and ~~sold~~security ~~its assets to JPMorgan Chase & Co~~obligations. ~~While~~We ~~the~~cannot ~~U.S.~~be ~~Department~~sure ofthat ~~Treasury,~~our ~~FDIC~~insurance ~~and~~coverage ~~Federal~~will ~~Reserve~~be ~~Board~~adequate ~~have~~or ~~implemented~~sufficient ~~a program~~ to ~~provide~~protect upus tofrom ~~$25~~or ~~billion of loans~~ to ~~financial institutions secured by certain of such government securities held by financial institutions to~~ mitigate ~~the~~liabilities ~~risk~~arising ofout ~~potential losses on the sale~~ of ~~such~~our ~~instruments,~~data ~~widespread~~privacy ~~demands~~and ~~for~~security ~~customer withdrawals or other liquidity needs of financial institutions for immediate liquidity may exceed the capacity of such program~~practices, ~~and there is no guarantee~~ that such ~~programs~~coverage will becontinue ~~sufficient. Additionally, it is uncertain whether the U.S. Department of Treasury, FDIC and Federal Reserve Board will provide access~~ to ~~uninsured~~be ~~funds~~available inon ~~the~~commercially ~~future~~reasonable interms ~~the event of the closure of other banks~~ or ~~financial~~at ~~institutions~~all, or that ~~they~~such ~~would~~coverage dowill sopay infuture ~~a timely fashion~~claims.

~~While~~Additionally, wesensitive ~~have~~information ~~not~~could ~~experienced~~be ~~any adverse impact to our liquidity or to our current and projected business operations~~leaked, ~~financial~~disclosed ~~condition~~ or ~~results~~revealed ~~of operations~~ as a result of ~~the~~or ~~matters~~in ~~relating~~connection towith ~~SVB, Signature Bank, Silvergate Capital Corp and First Republic Bank, uncertainty remains over liquidity concerns in~~ the ~~broader~~use ~~financial~~of ~~services~~generative ~~industry,~~AI ~~and~~technologies by our ~~business~~employees, ~~our~~personnel ~~business partners~~ or ~~industry as a whole may be adversely impacted in ways that we cannot predict at this time~~vendors.

~~Although~~Any welitigation ~~assess our banking relationships as we believe necessary~~ or ~~appropriate,~~adversarial ~~our~~proceedings ~~access to cash in amounts adequate to finance or capitalize our current and projected future business operations~~ could be ~~significantly~~costly ~~impaired by factors that affect the financial institutions with which we have banking relationships~~ and, intime-consuming ~~turn, us. These factors could include, among others, events such as liquidity constraints or failures, the ability~~ to perform obligations under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the financial services industrydefend. These factors could also include factors involving financial markets or the financial services industry generally. The results of events or concerns that involve one or more of these factors could include a variety of material and adverse impacts on our current and projected business operations and our financial condition and results of operations. These could include, but may not be limited to, delayed access to deposits or other financial assets or the uninsured loss of deposits or other financial assets; or termination of cash management arrangements and/or delays in accessing or actual loss of funds subject to cash management arrangements.

38We have been and may in the future become subject to legal proceedings and claims that arise in the ordinary course of business, such as claims brought by us or third parties in connection with commercial disputes or employment claims made by our current or former employees. Litigation or adversarial proceedings might result in substantial costs and may divert management’s attention and resources, which might seriously harm our business, reputation, overall financial condition and operating results. Insurance might not cover such claims, might not provide sufficient payments to cover all the costs to resolve one or more such claims and might not continue to be available on terms acceptable to us. Any claim brought by us or against us that is uninsured or underinsured could result in unanticipated costs, thereby harming our business.

International trade policies, including tariffs, sanctions and trade barriers, may adversely affect our business, financial condition, results of operations and prospects.

We operate in a global economy, which includes utilizing third-party suppliers in certain countries outside the United States. There is inherent risk, based on the complex relationships among the U.S. and the countries in which we conduct our business, that political, diplomatic and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. The current international trade and regulatory environment is subject to significant ongoing uncertainty. The U.S. government has recently announced substantial new tariffs affecting a wide range of products and jurisdictions and has indicated an intention to continue developing new trade policies, including with respect to the biopharmaceutical industry. In response, certain foreign governments have announced or implemented retaliatory tariffs and other protectionist measures. These developments have created a dynamic and unpredictable trade landscape, which may adversely impact our business, results of operations, financial condition and prospects.

Currently, certain of our suppliers are located outside of the United States. We also rely on specialized laboratory and manufacturing equipment, supplies, materials and precursor compounds, much of which is ultimately sourced from countries outside the United States, to advance our manufacturing and research and development efforts.

Current or future tariffs may result in increased research and development expenses, including with respect to increased costs associated with raw materials, manufacturing equipment, laboratory equipment and research materials and

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components. In addition, ~~widespread~~such ~~investor~~tariffs ~~concerns~~may ~~regarding~~increase ~~the~~our ~~U.S.~~supply orchain ~~international~~complexity ~~financial~~and ~~systems~~ could ~~result~~also inpotentially ~~less~~disrupt ~~favorable~~our ~~commercial~~existing ~~financing~~supply ~~terms,~~chain. ~~including~~Trade ~~higher~~restrictions ~~interest~~affecting ~~rates~~the orimport ~~costs~~of ~~and~~materials ~~tighter~~necessary ~~financial~~for ~~and~~clinical ~~operating~~trials ~~covenants,~~could orresult ~~systemic~~in ~~limitations~~delays onto ~~access~~our todevelopment ~~credit~~timelines. ~~and~~Increased ~~liquidity~~development ~~sources,~~costs ~~thereby~~and ~~making~~extended itdevelopment ~~more~~timelines ~~difficult~~could ~~for~~place us toat ~~acquire~~a ~~financing~~competitive ondisadvantage ~~acceptable~~compared ~~terms~~to orcompanies atoperating ~~all. Any decline~~ in ~~available~~regions ~~funding~~with ormore ~~access~~favorable totrade ~~our~~relationships ~~cash~~ and ~~liquidity resources~~ could, ~~among~~reduce ~~other~~investor ~~risks~~confidence, ~~adversely~~negatively ~~impact~~impacting our ability to ~~meet~~secure ~~our~~additional ~~operating~~financing ~~expenses,~~on ~~financial~~favorable ~~obligations~~terms or ~~fulfill~~at ~~our~~all. ~~other~~In ~~obligations~~addition, ~~result~~as inwe ~~breaches~~advance oftoward ~~our~~commercialization ~~financial and/or contractual obligations or result~~ in ~~violations~~the offuture, ~~federal~~tariffs ~~or state wage~~ and ~~hour~~trade ~~laws.~~restrictions ~~Any~~could ofhinder ~~these~~our ~~impacts,~~ability orto ~~any~~establish ~~other~~cost-effective ~~impacts~~supply ~~resulting from the factors described above or other related or similar factors not described above~~chains, ~~could~~negatively ~~have~~impacting ~~material adverse impacts on~~ our ~~liquidity~~growth ~~and our current and/or projected business operations and financial condition and results of operations~~prospects.

The complexity of announced or future tariffs may also increase the risk that we or our future customers or suppliers may be subject to civil or criminal enforcement actions in the United States or foreign jurisdictions related to compliance with trade regulations. Foreign governments may also adopt non-tariff measures, such as procurement preferences or informal disincentives to engage with, purchase from or invest in U.S. entities, which may limit our ability to compete internationally and attract non-U.S. investment, employees, customers and suppliers. Foreign governments may also take other retaliatory actions against U.S. entities, such as decreased intellectual property protection, increased enforcement actions or delays in regulatory approvals, which may result in heightened international legal and operational risks. In addition, the United States and other governments have imposed and may continue to impose additional sanctions, such as trade restrictions or trade barriers, which could restrict us from doing business directly or indirectly in or with certain countries or parties and may impose additional costs and complexity to our business.

Trade disputes, tariffs, restrictions and other political tensions between the United States and other countries may also exacerbate unfavorable macroeconomic conditions including inflationary pressures, foreign exchange volatility, financial market instability and economic recessions or downturns. The ultimate impact of current or future tariffs and trade restrictions remains uncertain and could materially and adversely affect our business, financial condition and prospects. While we actively monitor these risks, any prolonged economic downturn, escalation in trade tensions or deterioration in international perception of U.S.-based companies could materially and adversely affect our business, ability to access the capital markets or other financing sources, results of operations, financial condition and prospects. In addition, tariffs and other trade developments have and may continue to heighten the risks related to the other risk factors described elsewhere in this report.

Risks Related to Manufacturing

The manufacturing of cell therapies is very complex. We are subject to a multitude of manufacturing risks, any of which could substantially increase our costs, delay our programs or limit supply of our product candidates.

Developing commercially viable manufacturing processes for cell therapies is a difficult and uncertain task and requires significant expertise and capital investment. We are developing and implementing manufacturing processes for our product candidates. In particular, for autologous cell therapies, the starting material is the patient’s own cells, which inherently adds complexity and variability to the manufacturing process. In addition, our ability to consistently and reliably manufacture our cell therapy product candidates is essential to our success, and there are risks associated with scaling to the level required for advanced clinical trials or commercialization, including cost overruns, potential problems with process scale-up, process reproducibility, stability issues, consistency and timely availability of reagents or raw materials. Furthermore, our manufacturing processes may have significant dependencies on third parties, which will pose additional risks to our manufacturing capabilities. Additionally, we do not yet have sufficient information to reliably estimate the cost of the commercial manufacturing and processing of our product candidates, and the actual cost to manufacture and process our product candidates could materially and adversely affect the commercial viability of our product candidates. As a result, we may never be able to develop a commercially viable product.

In addition to the factors mentioned above, the overall process of manufacturing cell therapies is extremely susceptible to product loss due to low cell viability, contamination, equipment failure or improper installation or operation of equipment, or vendor or operator error. Even minor deviations from normal manufacturing and distribution processes for any of our product candidates could result in reduced production yields, impact to key product quality attributes and other supply disruptions. Product defects can also occur unexpectedly. These deviations and disruptions could delay our programs. If we are not able to capably manage this complexity and variability, our ability to timely and successfully provide our product candidates to patients could be delayed. In addition, the complexities of utilizing a patient’s own cells as the starting material requires that we have suitable cells capable of yielding a viable cell therapy product, which may not be possible for severely immune-compromised or heavily pre-treated patients.

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reduction of our workforce that supported the Los Angeles manufacturing facility that we closed in 2025, may result in the loss of institutional knowledge and expertise and delays in our manufacturing processes, which may harm our business and financial condition. We may also incur additional costs and expenses related to the recruitment of replacement personnel.

The process of manufacturing these product candidates will be susceptible to additional risks, given the need to maintain aseptic conditions throughout the manufacturing process. Contamination with microbes, viruses or other pathogens in either the donor material or materials utilized in the manufacturing process or ingress of microbiological material at any point in the process may result in contaminated, unusable product or necessitate the closing of a manufacturing facility for an extended period of time to allow us to investigate and remedy the contamination. These types of contaminations could result in delays in the manufacture of products, which could result in delays in the development of our product candidates. These contaminations could also increase the risk of adverse side effects.

Any adverse developments affecting manufacturing operations for our product candidates may result in lot failures, inventory shortages, shipment delays, product withdrawals or recalls or other interruptions in supply that could delay the development of our product candidates. If we are unable to obtain sufficient supply of our product candidates, whether due to production shortages or other supply interruptions, our clinical trials or regulatory approvals may be delayed. We may also have to write off inventory, incur other charges and expenses for supply of product that fails to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives. In addition, parts of the supply chain may have long lead times or may come from a small number of suppliers. If we are not able to appropriately manage our supply chain, our ability to successfully produce our product candidates could be delayed or harmed. Inability to meet the demand for our product candidates could damage our reputation and the reputation of our products among physicians, healthcare payors, patients or the medical community that supports our product development efforts, including hospitals and outpatient clinics. Furthermore, the manufacturing facilities in which our product candidates will be made could be adversely affected by earthquakes or fires and other natural disasters, equipment failures, labor shortages, power failures, health epidemics and numerous other factors. If any of these events were to occur and impact our manufacturing facilities, our business would be materially and adversely affected.

Cell-based therapies rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.

Our product candidates require many specialty raw materials. As a result, we may be required to outsource aspects of our manufacturing supply chain. Many of the specialty raw materials may be manufactured by small companies with limited resources and experience to support a commercial product, and the suppliers may not be able to deliver raw materials to our specifications. In such case, identifying and engaging an alternative supplier or manufacturer could result in delay, and we may not be able to find other acceptable suppliers or manufacturers on acceptable terms, or at all. Switching suppliers or manufacturers may involve substantial costs and is likely to result in a delay in our desired clinical and commercial timelines. If we change suppliers or manufacturers for commercial production, applicable regulatory agencies may require us to conduct additional studies or trials. If key suppliers or manufacturers are lost, or if the supply of the materials is diminished or discontinued, we may not be able to develop, manufacture and market our product candidates in a timely and competitive manner, or at all. An inability to continue to source product from any of these suppliers, which could be due to a number of issues, including regulatory actions or requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputes or shortages, unexpected demands or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which could adversely and materially affect our product sales and operating results or our ability to conduct clinical trials, either of which could significantly harm our business.

In addition, those suppliers may not have the capacity to support commercial products manufactured by biopharmaceutical firms. The suppliers may be ill-equipped to support our needs, especially in non-routine circumstances like an FDA or comparable foreign regulatory authority inspection, or medical crises such as widespread contamination. We may not be able to contract with these companies on acceptable terms or at all. Accordingly, we may experience delays in receiving key raw materials to support clinical or commercial manufacturing. In addition, some raw materials are currently available from a single supplier, or a small number of suppliers. We cannot be sure that these suppliers will remain in business, or that they will not be purchased by one of our competitors or another company that is not interested in continuing to produce these materials for our intended purpose. These factors could cause the delay of studies or trials, regulatory submissions, required approvals or commercialization of product candidates that we develop, cause us to incur higher costs and prevent us from commercializing our product candidates successfully.

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We currently manufacture drug products for our clinical trials ourselves. Delays in further qualifying or in receiving regulatory approvals for any manufacturing facility or product candidates, or in expanding our manufacturing capacity, could delay our development plans and thereby limit our ability to generate product revenues.

We have built our own manufacturing facility, LyFE, in Bothell, Washington. ~~The~~This facility is designed to support the production of nonclinical and clinical development product candidates and early commercialization of products, and ongoing facility and equipment qualification to support clinical production is required. If we are not able to further qualify our existing facility or the appropriate regulatory approvals for the facility are delayed, or if we are unable to otherwise expand our manufacturing capacity, including for LYL273, which we acquired through an exclusive license in November 2025 and for which we intend to transition manufacturing to LyFE, we may be unable to manufacture sufficient quantities of our product candidates, if at all, which would limit our development activities and our opportunities for growth. AsIf ~~part~~LyFE offails ~~the~~to ~~acquisition~~have ofsufficient ~~ImmPACT~~capacity to provide drug supply for our ongoing and planned trials and through potential commercial launch, our business and financial condition may be significantly harmed, and we ~~own~~may incur significant additional costs and ~~operate~~delays arelated ~~manufacturing~~to ~~facility~~the indevelopment ~~Los~~of ~~Angeles,~~our ~~California~~product candidates. If we fail to adequately ~~technology~~transition ~~transfer~~manufacture ~~IMPT-314~~of LYL273 to LyFE or fail to qualify LyFE for additional production, our business and financial condition may be significantly harmed, and we may incur significant additional costs and delays related to the development of ~~IMPT-314~~LYL273.

In addition, our manufacturing facilities will be subject to ongoing, periodic inspection by the FDA, competent authorities of EU Member States and other comparable regulatory authorities to ensure compliance with cGMPs and current Good Tissue Practices (cGTPs). Our failure to follow and document our adherence to these regulations or other regulatory requirements may lead to significant delays in the availability of products for clinical or, in the future, commercial use. This may result in the modification or termination of or a hold on a clinical trial or may delay or prevent filing or approval of commercial marketing applications for our product candidates. We also may encounter problems with the following:

•achieving adequate or clinical-grade materials that meet regulatory authority standards or specifications with consistent and acceptable production yield and costs;

•maintaining continuity among our key manufacturing-related electronic systems;

•shortages of qualified personnel, raw materials or key contractors; and

•ongoing compliance with cGMP regulations and other requirements of the FDA, the EU or other competent regulatory authorities.

Failure to comply with applicable regulations could also result in sanctions being imposed on us, including fines, injunctions, civil and/or criminal penalties, a requirement to terminate, vary, suspend or put on hold one or more of our clinical trials, failure of regulatory authorities to grant marketing approval of our product candidates, delays, suspension, variation or withdrawal of approvals, license suspension or revocation, labelling restrictions or requirements in an approved label, seizures or recalls of product candidates or approved products, total or partial suspension of production, distribution, manufacturing or clinical trials, operating restrictions and criminal prosecutions, any of which could harm our business.

Developing advanced manufacturing techniques and process controls is required to fully utilize our facilities. Without further investment, advances in manufacturing techniques may render our facilities and equipment inadequate or obsolete. We may also require further investment to build additional manufacturing facilities or expand the capacity of our existing ones.

~~The~~If ~~manufacturing~~our ofclinical ~~cellular~~manufacturing ~~therapies~~facility isin ~~very~~Bothell, ~~complex.~~Washington Weor ~~are~~any ~~subject~~of toour apotential ~~multitude~~contract of manufacturing ~~risks,~~organizations ~~any~~is ofdamaged ~~which~~or ~~could~~destroyed ~~substantially~~or ~~increase~~production ~~our~~at ~~costs,~~these ~~delay~~facilities ~~our~~is ~~programs~~otherwise orinterrupted, ~~limit~~our ~~supply~~business ofwould ~~our~~be ~~product~~negatively ~~candidates~~affected.

~~Developing~~We ~~commercially~~operate ~~viable~~a manufacturing ~~processes~~facility ~~for~~in ~~cellular~~Bothell, ~~therapies~~Washington ~~is a difficult~~ and ~~uncertain~~may ~~task~~rely ~~and~~on ~~requires~~potential ~~significant~~third-party ~~expertise~~contract ~~and~~manufacturing ~~capital~~organizations ~~investment.~~to Wemeet ~~are~~our ~~developing~~current and ~~implementing~~future manufacturing ~~processes~~needs. ~~for~~If our ~~product~~manufacturing ~~candidates.~~facilities Inor ~~particular,~~any ~~for~~facility ~~autologous~~in ~~cell~~our ~~therapies~~manufacturing network, or the ~~starting~~equipment ~~material~~in these facilities, is ~~the~~either ~~patient’s~~damaged ~~own~~or ~~cells,~~destroyed ~~which~~or ~~inherently~~otherwise ~~adds~~adversely ~~complexity~~affected by earthquakes or fires and ~~variability~~other natural disasters, equipment failures, labor shortages, power failures, health epidemics or other factors, we may not be able to ~~the~~quickly or inexpensively replace our manufacturing ~~process.~~capacity, Inif ~~addition~~at all, and our ~~ability~~business towould ~~consistently~~be materially and ~~reliably~~adversely ~~manufacture~~affected. ~~our~~In ~~cell~~the ~~therapy~~event ~~product~~of ~~candidates~~a istemporary ~~essential~~or toprotracted ~~our~~loss ~~success~~of a facility or its equipment, ~~and~~we ~~there~~may ~~are~~not ~~risks~~be ~~associated~~able ~~with~~to ~~scaling~~transfer manufacturing to a third party in the ~~level~~time required ~~for~~to ~~advanced~~maintain ~~clinical~~supply. ~~trials~~Even orif ~~commercialization~~we are able to transfer manufacturing to a third party, ~~including~~the ~~cost~~shift ~~overruns~~would likely be expensive and time-consuming, ~~potential~~particularly ~~problems~~since the new facility would need to comply with ~~process~~the necessary regulatory requirements or may require regulatory approval before selling any products manufactured at that facility. Such an event could substantially delay our clinical trials or commercialization of our product candidates.

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scale-up, process reproducibility, stability issues, consistency and timely availability of reagents or raw materials. Furthermore, our manufacturing processes may have significant dependencies on third parties, which will pose additional risks to our manufacturing capabilities. Additionally, we do not yet have sufficient information to reliably estimate the cost of the commercial manufacturing and processing of our product candidates, and the actual cost to manufacture and process our product candidates could materially and adversely affect the commercial viability of our product candidates. As a result, we may never be able to develop a commercially viable product.

In addition to the factors mentioned above, the overall process of manufacturing cellular therapies is extremely susceptible to product loss due to low cell viability, contamination, equipment failure or improper installation or operation of equipment, or vendor or operator error. Even minor deviations from normal manufacturing and distribution processes for any of our product candidates could result in reduced production yields, impact to key product quality attributes and other supply disruptions. Product defects can also occur unexpectedly. These deviations and disruptions could delay our programs. If we are not able to capably manage this complexity and variability, our ability to timely and successfully provide our product candidates to patients could be delayed. In addition, the complexities of utilizing a patient’s own cells as the starting material requires that we have suitable cells capable of yielding a viable cell therapy product, which may not be possible for severely immune-compromised or heavily pre-treated patients.

The process of successfully manufacturing products for clinical testing and commercialization may be particularly challenging, even if such products otherwise prove to be safe and effective. The manufacture of these product candidates involves complex processes. Some of these processes require specialized equipment and highly skilled and trained personnel, for which there is significant competition. The loss of such manufacturing personnel, including at our newly acquired manufacturing facility in Los Angeles, California, may result in the loss of institutional knowledge and expertise and delays in our manufacturing processes, which may harm our business and financial condition. We may also incur additional costs and expenses related to the recruitment of replacement personnel.

Furthermore, the manufacturing facilities in which our product candidates will be made could be adversely affected by earthquakes or fires and other natural disasters, equipment failures, labor shortages, power failures, health epidemics and numerous other factors. If any of these events were to occur and impact our manufacturing facilities, our business would be materially and adversely affected.

If our clinical manufacturing facility in Bothell, Washington, or recently acquired manufacturing facility in Los Angeles, California, or any of our potential contract manufacturing organizations is damaged or destroyed or production at these facilities is otherwise interrupted, our business would be negatively affected.

We operate a manufacturing facility in Bothell, Washington, and recently acquired a manufacturing facility in Los Angeles, California in connection with the acquisition of ImmPACT and may rely on potential third-party contract manufacturing organizations to meet our current and future manufacturing needs. If our manufacturing facilities or any facility in our manufacturing network, or the equipment in these facilities, is either damaged or destroyed, we may not be able to quickly or inexpensively replace our manufacturing capacity, if at all. In the event of a temporary or protracted loss of a facility or its equipment, we may not be able to transfer manufacturing to a third party in the time required to maintain supply. Even if we are able to transfer manufacturing to a third party, the shift would likely be expensive and time-consuming, particularly since the new facility would need to comply with the necessary regulatory requirements or may

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require regulatory approval before selling any products manufactured at that facility. Such an event could substantially delay our clinical trials or commercialization of our product candidates.

Currently, we maintain insurance coverage against damage to our properties and to cover business interruption and research and development restoration expenses. However, our insurance coverage may not reimburse us, or may not be sufficient to reimburse us, for any expenses or losses we may suffer. We may be unable to meet our requirements for our product candidates if there were a catastrophic event or failure of our current manufacturing facilities or processes.

We may rely on third parties to manufacture our product candidates, which ~~subjects~~could subject us to risks and ~~could~~ delay or prevent our development and/or commercialization, if approved, of our product candidates.

We may rely on third parties to manufacture our current or future product candidates. We may be unable to identify manufacturers for our product candidates or the materials required to develop the ~~cellular~~cell therapy on acceptable terms or at all because the number of potential manufacturers is limited. We ~~are~~regularly ~~currently~~evaluate ~~evaluating~~ third‑party manufacturing options as part of an overall CAR T-cell manufacturing strategy to build scale and reduce cost. Utilizing a third-party cGMP manufacturer will require the transfer and testing of manufacturing and analytical methods to demonstrate substantially equivalent processes and performance for regulatory filings and interactions as required. Such potential third-party manufacturers may be unable to timely formulate and manufacture our product or produce the quantity and quality required to meet our clinical and commercial needs, if any.

Furthermore, the facilities used by manufacturers are subject to ongoing periodic unannounced inspections by the FDA and corresponding state agencies and comparable foreign regulatory authorities to ensure strict compliance with government regulations and corresponding foreign standards. Despite our efforts to audit and verify regulatory compliance, third-party manufacturers may be found on regulatory inspection by the FDA or comparable foreign regulatory authorities to be noncompliant with cGMP regulations and requirements in relation to the manufacture of our product candidates. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or comparable foreign regulatory authorities, we will not be able to obtain and/or maintain regulatory approval for our product candidates manufactured in these facilities. In addition, we have limited control over the ability of our third-party manufacturers to maintain adequate control, quality assurance and qualified personnel required to meet our clinical and commercial needs, if any. If the FDA or a comparable foreign regulatory authority does not approve the manufacture of our product candidates at these facilities or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved. In addition, any failure to achieve and maintain compliance with these laws, regulations and standards could subject us to the risk that we may have to suspend the manufacturing of our product candidates or that any approvals we have obtained could be revoked, which would adversely affect our business and reputation. Moreover, noncompliance with cGMP regulations or requirements may result in shutdown of the third-party vendor or invalidation of drug product lots or processes. In some cases, a product recall may be warranted or required, which would materially affect our ability to supply and market our products.

We may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in the manufacturing process for our products. Also, our third-party manufacturers could breach or terminate their ~~agreement~~agreements with us because of their own financial difficulties or business priorities at a time that is costly or otherwise inconvenient for us. If we were unable to find adequate replacement or another acceptable solution in time, our clinical trials could be delayed or our commercial activities could be harmed.

Furthermore, our third-party manufacturers would also be subject to the same risks we face in developing our own manufacturing capabilities, as described above. Each of these risks could delay our clinical trials, the approval, if any, of our product candidates by the FDA or comparable foreign regulatory authorities or the commercialization of our product candidates or result in higher costs or deprive us of potential product revenue.

Cell-based therapies rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.

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in a timely and competitive manner, or at all. An inability to continue to source product from any of these suppliers, which could be due to a number of issues, including regulatory actions or requirements affecting the supplier, adverse financial or other strategic developments experienced by a supplier, labor disputes or shortages, unexpected demands or quality issues, could adversely affect our ability to satisfy demand for our product candidates, which could adversely and materially affect our product sales and operating results or our ability to conduct clinical trials, either of which could significantly harm our business.

Risks Related to Our Dependence on Third Parties

We rely on third parties to assist in conducting and monitoring our clinical trials and for some of our research and ~~non‑clinical~~nonclinical studies for our product candidates, and, if those third parties do not successfully carry out their contractual duties, comply with regulatory requirements or otherwise perform satisfactorily, we may not be able to obtain regulatory approval or commercialize product candidates, or such approval or commercialization may be delayed, and our business may be substantially harmed.

We rely on medical institutions, clinical investigators, contract laboratories and other third parties, such as CROs, to help conduct GCP-compliant clinical trials on our product candidates properly and on time. For example, we are relying on CROs to ~~conduct~~assist ~~significant~~us ~~parts~~in ofconducting our ~~IMPT~~ronde-~~314~~cel clinical trials, including the pivotal PiNACLE trial in the 3L+ setting and the PiNACLE-H2H trial in the 2L setting and in the conduct of the ongoing U.S. Phase 1/2 clinical ~~trials~~trial for LYL273. Negotiating budgets and contracts with CROs and ~~study~~clinical sites may result in delays to our development timelines and increased costs. Switching or adding CROs involves substantial cost and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. ~~Though~~There ~~we carefully manage our relationships with our CROs, there~~ can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

In addition, any third parties conducting our clinical trials or nonclinical studies will not be our employees, and, except for remedies available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our programs. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain are compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials or nonclinical studies may be extended, delayed or terminated, and we may not be able to obtain regulatory approval or successfully commercialize our product candidates. Consequently, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase substantially and our ability to generate revenue could be delayed significantly.53

We rely on these parties for execution of our nonclinical studies and clinical trials, and generally do not control their activities. Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA and comparable foreign regulatory authorities require us to comply with standards, commonly referred to as GCPs, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. If we or any of our CROs or other third parties, including trial sites, fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials complies with applicable GCPs. In addition, our clinical trials must be conducted with product produced under cGMP conditions. Our failure to comply with these regulations and requirements may require us to add patients to or repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violates federal, state or foreign fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

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WeIn ~~have~~addition, aany ~~CRO~~third ~~located~~parties inconducting ~~China.~~our ~~International~~clinical ~~tension~~trials or ~~conflict~~nonclinical ~~between~~studies ~~the~~will ~~United~~not ~~States~~be our employees, and, ~~China~~except ~~could~~for ~~result~~remedies inavailable ato ~~disruption~~us inunder our ~~contractual~~agreements ~~relationship~~ with ~~this~~such ~~CRO~~third parties, we cannot control whether or ~~any~~not ~~other~~they ~~CROs~~devote wesufficient ~~may~~time ~~engage~~and inresources ~~China~~to our programs. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, ~~which~~if ~~could~~they ~~delay~~need to be replaced or ~~otherwise~~if ~~negatively~~the ~~impact~~quality ~~progress~~or inaccuracy ~~our~~of ~~IMPT-314~~the clinical ~~programs.~~data ~~For~~they ~~example,~~obtain ~~the~~are ~~tensions~~compromised ~~between~~due to the ~~United~~failure ~~States~~to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials or nonclinical studies may be extended, delayed or terminated, and ~~China~~we ~~have~~may ~~led~~not be able to aobtain ~~series~~regulatory ofapproval ~~tariffs~~or ~~and~~successfully ~~sanctions~~commercialize ~~being~~our ~~imposed~~product bycandidates. Consequently, our results of operations and the ~~United~~commercial ~~States~~prospects onfor ~~imports~~our ~~from~~product ~~China~~candidates would be harmed, asour ~~well~~costs ascould ~~other~~increase ~~business~~substantially ~~restrictions~~and our ability to generate revenue could be delayed significantly.

We rely on these parties for execution of our nonclinical studies and clinical trials, and generally do not control their activities. Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA and comparable foreign regulatory authorities require us to comply with standards, commonly referred to as GCPs, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. If we or any of our CROs or other third parties, including our clinical investigators, fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials complies with applicable GCPs. In addition, our clinical trials must be conducted with product produced under cGMP conditions. The failure by us or third parties engaged by us to comply with these regulations and requirements may require us to add patients to or repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violates federal, state or foreign fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

If any of our relationships with the third parties that we currently use or that we may use in the future terminates, we may not be able to enter into arrangements with alternative third parties or do so on commercially reasonable terms. As a result, delays occur, which can materially impact our ability to meet desired research and clinical development timelines.

We do and will continue to or intend to rely on outside scientists and clinical trial investigators and their third-party research institutions for research and development and clinical testing of our product candidates. These scientists, investigators and institutions may have other commitments or conflicts of interest, which could limit our access to their expertise and harm our ability to leverage our technology platforms.

We rely on our third-party research institution collaborators for some research capabilities. However, the research we are funding constitutes only a small portion of the overall research of each research institution. Other research being conducted by these institutions may at times receive higher priority than research on the programs we are funding. We typically have less control of the research, clinical trial protocols and patient enrollment than we might with activity led by our employees.

The clinical trial investigators and study teams and outside scientists who conduct the research and development upon which portions of our product candidate regulatory submissions depend are not our employees; rather, they serve as either independent contractors or the primary investigators under research collaboration agreements that we have with their sponsoring academic or research institutions. Such investigators, study staff, scientists and collaborators may have other commitments that would limit their availability to us. Although our scientific advisors generally agree not to do competing work, if an actual or potential conflict of interest between their work for us and their work for another entity arises, we may lose their services. These factors could adversely affect the timing of the clinical trials, the timing of receipt and reporting of clinical data, the timing of our U.S. regulatory submissions and comparable foreign applications and our ability to conduct our current and planned clinical trials. It is also possible that some of our valuable proprietary knowledge may become publicly known through these clinical investigators and study staff or scientific advisors if they breach their confidentiality agreements with us, which would cause competitive harm to, and have an adverse effect on, our business.

We have in the past, and we may in the future, form or seek collaborations or strategic alliances or enter into additional licensing arrangements, and we may not realize the benefits of such alliances or licensing arrangements.

We have entered into research and development collaborations in the past, and may in the future, enter into additional license and collaboration arrangements. Any collaboration arrangement that we enter into is subject to numerous risks, which may include the following:

•the collaborator has significant discretion in determining the efforts and resources that they will apply to a program or product candidate under the collaboration;

•the collaborator may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competitive products or other reasons, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;

•the collaborator may delay or halt clinical trials, provide insufficient funding for a clinical trial, preferentially enroll patients on a portion of a clinical trial not testing our product candidates, stop a clinical trial, abandon a product candidate, repeat or conduct new clinical trials, or require a new formulation of a product candidate for clinical testing;

•the collaborator could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;

•the collaborator may not commit sufficient resources to marketing and distribution of our products;

•the collaborator may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;

•disputes may arise between us and the collaborator that cause the delay or termination of the research, development or commercialization of our product candidates, or that result in costly litigation or arbitration that diverts management attention and resources;

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•the collaboration may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and

•the collaborator may own or co-own intellectual property covering our product candidates that results from our collaborating with them, and in such cases, we would not have the exclusive right to commercialize such intellectual property.

In particular, failure by any collaborator to meet its obligations under our collaboration agreements or to apply sufficient efforts at developing and commercializing collaboration products may adversely affect our business, financial condition and our results of operations. For example, we were previously party to a research and development collaboration with GSK for our NY-ESO-1 program and other potential product opportunities and, effective December 2022, GSK terminated the agreement and discontinued its development of product candidates targeting NY-ESO-1, including the second‑generation product candidates that incorporated our genetic and epigenetic reprogramming technologies. No patients had been treated with these product candidates and, given the early stage of these second‑generation programs, the termination was not based on any clinical efficacy or safety data from these programs. We have also discontinued any further work on these programs.

We may form or seek further strategic alliances, create joint ventures or collaborations, or enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates, our research and any future product candidates that we may pursue. Such alliances will be subject to many of the risks set forth above. Moreover, any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business. In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex.

As a result of these risks, we may not be able to realize the benefit of our existing collaboration or any future collaborations or licensing agreements we may enter into. Any delays in entering into new collaborations or strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition and results of operations.

We recently acquired ImmPACT and may not realize the benefits of such acquisition or any potential future collaborations, licenses, product acquisitions or other strategic transactions.

We recently acquired ImmPACT, a privately‑owned clinical stage biotechnology company developing next‑generation CAR T‑cell product candidates, and may desire to enter into in the future, collaborations, licenses or other strategic transactions for the acquisition of products or business opportunities, in each case where we believe such arrangement will complement or augment our existing business. These relationships or transactions, or those like them, may require us to incur nonrecurring and other charges, increase our near- and long-term expenditures, issue securities that dilute our existing stockholders, reduce the potential profitability of the products that are the subject of the relationship or disrupt our management and business. In addition, we face significant competition in seeking appropriate strategic alliances and transactions and the negotiation process is time-consuming and complex, and there can be no assurance that we can enter into any of these transactions even if we desire to do so. Moreover, we may not be successful in our efforts to establish a strategic alliance or other alternative arrangements for any future product candidates and programs because our research and development pipeline may be insufficient, our product candidates or programs may be deemed to be at too early a stage of development for collaborative effort and third parties may not view our product candidates and programs as having the requisite potential to demonstrate a positive benefit/risk profile. Any delays in entering into new strategic alliance agreements related to our product candidates could also delay the development and commercialization of our product candidates and reduce their competitiveness even if they reach the market.

We may not be able to successfully integrate ImmPACT into our business, including manufacturing of IMPT-314 at LyFE, or to realize the anticipated benefits of the acquisition.

Combining our company and ImmPACT may be more difficult, costly or time consuming than expected, and we and ImmPACT may fail to successfully integrate the two businesses or to realize the anticipated benefits of the acquisition. The success of the acquisition will depend, in part, on the ability to realize the anticipated cost savings from integrating

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ImmPACT’s operations with ours, including our plans to technology transfer IMPT-314 to LyFE. This integration will depend substantially on our and ImmPACT’s ability to consolidate operations, corporate cultures, systems and procedures and to eliminate redundancies and costs. We may not be able to combine our business with that of ImmPACT without encountering difficulties that could adversely affect the ability to maintain relationships with existing partners and employees, such as:

•the loss of key employees, including our manufacturing personnel, and associated costs;

•the disruption of operations and business;

•inability to maintain and increase competitive presence;

•possible inconsistencies in standards, control procedures and policies;

•inability to complete trials in a manner previously planned or announced;

•additional costs or unexpected problems with manufacturing IMPT-314 at LyFE, executing clinical trials, loss of key personnel or with the licensed technology; and/or

•potential unknown liabilities associated with the ImmPACT acquisition.

Additionally, general market and economic conditions or governmental actions generally may inhibit our successful integration of ImmPACT.

Further, we acquired ImmPACT with the expectation that this acquisition will result in various benefits including, among other things, benefits relating to a strengthened market position for the combined company, cost savings and operating efficiencies. Achieving the anticipated benefits of this acquisition is subject to a number of uncertainties, including whether we integrate ImmPACT in an efficient and effective manner, and general competitive factors in the marketplace. Failure to achieve these anticipated benefits on the anticipated timeframe, or at all, including manufacturing IMPT-314 at LyFE, could result in a reduction in the market price of our securities as well as in increased costs, decreases in the amount of expected revenues and diversion of management’s time and energy and could materially and adversely affect our business, financial condition and operating results. Additionally, we will or have made fair value estimates of certain assets and liabilities in recording the ImmPACT acquisition. Actual values of these assets and liabilities could differ from our estimates, which could result in our not achieving the anticipated benefits of the acquisition. ImmPACT may have liabilities that we failed or were unable to discover in the course of performing due diligence investigations, or we may not have correctly assessed the significance of certain liabilities of ImmPACT identified in the course of our due diligence. Any such liabilities, individually or in the aggregate, could have an adverse effect on our business, financial condition and results of operations. Finally, any cost savings that are realized may be offset by losses in revenues or other charges to earnings.

Failure to successfully address these and other issues related to the acquisition could have a material adverse effect on our financial condition and results of operations and could adversely affect our ability to successfully implement our business strategy.

We depend on the enrollment and retention of patients in our current and planned clinical trials for our product candidates. If we experience delays or difficulties enrolling or retaining patients in our clinical trials, our research and development efforts and business, financial condition, and results of operations could be materially adversely affected.

Successful and timely completion of clinical trials require that we enroll and retain a sufficient number of ~~study~~trial participants. Any clinical trials we conduct may be subject to delays for a variety of reasons, including as a result of patient enrollment taking longer than anticipated, manufacturing failures resulting in patients being unable to be treated, patient withdrawal or adverse events. These types of developments have in the past, and could in the future, cause us to delay a trial or halt further development.

Our clinical trials compete with other clinical trials that are in the same therapeutic areas as our product candidates, and this competition reduces the number and types of patients available to usbe treated with ronde‑cel or LYL273 in our trials, as some patients ~~who~~ might ~~have~~choose ~~opted~~ to enroll in a trial conducted by one of our ~~trials~~competitors ~~may~~or, ~~instead~~in ~~opt~~the case of ronde-cel, to ~~enroll~~receive intreatment awith ~~trial~~the ~~being~~commercially ~~conducted~~available byCD19 ~~one~~CAR T-cell therapies, liso-cel or axi-cel, outside of our ~~competitors~~trials. There are ~~also~~ currently a number of companies with approved and investigational CAR T‑cell therapies and bispecific T-cell engagers in our therapeutic areas, which could further limit the number of potential patients available to us. We may also encounter additional challenges and slower than anticipated enrollment in our clinical trials if more of our competitors obtain FDA approval before us in the same therapeutic areas as our product candidates.

Moreover, enrolling patients in clinical trials for diseases in which there is an approved standard of care is challenging, as patients will first receive the applicable standard of care. Many patients who respond positively to the standard of care do not enroll in clinical trials. This may limit the number of eligible patients able to enroll in our clinical trials who have the potential to benefit from our product candidates and could extend development timelines or increase costs for these programs. Patients who fail to respond positively to the standard of care treatment will be eligible for clinical trials of unapproved drug candidates. However, these prior treatment regimens may render our therapies less effective in clinical trials.

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trials who have the potential to benefit from our product candidates and could extend development timelines or increase costs for these programs. Patients who fail to respond positively to the standard of care treatment will be eligible for clinical trials of unapproved drug candidates. However, these prior treatment regimens may render our therapies less effective in clinical trials.

Because the number of qualified clinical investigators and clinical trial sites is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites.

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We may experience delays in enrollment in our current and planned clinical trials due to factors outside our control. For example, some patients may not be able to comply with clinical trial protocols due to lack of healthcare support or potential interruptions of healthcare services. Our ability to recruit and retain patients, principal investigators and site staff may also be hindered, which would adversely affect our trial operations.

Patient enrollment depends on many additional factors, including:

•the size and nature of the patient population;

•the severity of the disease under investigation;

•eligibility criteria for the trial;

•the proximity of patients to clinical sites;

•the design of the clinical protocol;

•the ability to obtain and maintain patient consents;

•perceived risks and benefits of the product candidate under evaluation, including any perceived risks associated with genetically modified product candidates;

•the ability to recruit clinical trial investigators with the appropriate competencies and experience;

•the risk that patients enrolled in clinical trials will drop out of the trials before the administration of our product candidates or trial completion;

•the availability of competing clinical trials;

•the availability of new drugs approved for the indication that the clinical trial is investigating; and

•clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available approved or investigational therapies.

These factors may make it difficult for us to enroll enough patients to complete our clinical trials in a timely and cost-effective manner. Delays in the completion of any clinical trial of our product candidates will increase our costs, slow down our product candidate development and approval process and delay or potentially jeopardize our ability to commence product sales and generate revenue. In addition, some of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

We ~~face~~do ~~substantial~~and ~~competition~~will incontinue ~~rapidly~~to ~~changing~~or ~~industries~~intend to rely on outside scientists and clinical trial investigators and their third-party research institutions for research and development and clinical testing of our product candidates. These scientists, ~~which~~investigators and institutions may ~~result~~have inother ~~others~~commitments ~~discovering~~or conflicts of interest, ~~developing~~which orcould ~~commercializing~~limit ~~products~~our ~~before~~access orto ~~more~~their ~~successfully~~expertise ~~than~~and weharm doour ability to leverage our technologies.

~~The~~We ~~biotechnology~~rely ~~and pharmaceutical industries are highly competitive and subject to significant and rapid technological change. Our success is substantially dependent~~ on our ~~ability~~third-party toresearch ~~discover,~~institution ~~develop~~collaborators ~~and obtain marketing approval~~ for ~~new~~some ~~and~~research ~~innovative products on a cost-effective basis and to market them successfully~~capabilities. ~~We face and will continue to face competition from numerous pharmaceutical and biotechnology enterprises~~However, asthe ~~well~~research aswe ~~from~~are ~~academic~~funding ~~institutions,~~constitutes ~~government~~only ~~agencies~~a ~~and~~small ~~private~~portion ~~and~~of ~~public~~the overall research ~~institutions, many~~ of ~~whom~~each ~~have~~research ~~market presence, engineering, technical and marketing capabilities and financial, personnel and other resources substantially greater than ours~~institution. ~~These~~Other ~~organizations may conduct similar~~ research, ~~seek~~being ~~patent~~conducted ~~protection~~by ~~and~~these ~~establish~~institutions ~~collaborative arrangements for research, development, manufacturing and marketing of products that compete with our product candidates. Smaller and other early-stage companies~~ may ~~also~~at ~~prove~~times toreceive behigher ~~significant~~priority ~~competitors,~~than ~~particularly~~research ~~through~~on ~~collaborative~~the ~~arrangements~~programs ~~with~~we ~~large~~are ~~and established companies~~funding. ~~Mergers~~We ~~and~~typically ~~acquisitions~~have inless ~~the~~control ~~pharmaceutical~~of ~~and biotechnology industries may result in even more resources, including intellectual property that may be necessary or useful for~~ the ~~development and commercialization of our product candidates~~research, ~~being~~clinical ~~concentrated~~trial inprotocols ~~our competitors~~ and ~~becoming~~patient ~~unavailable~~enrollment tothan uswe onmight ~~commercially~~with ~~reasonable~~activity ~~terms~~led orby atour ~~all~~employees. ~~Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.~~

46The clinical trial investigators and study teams and outside scientists who conduct the research and development upon which portions of our product candidate regulatory submissions depend are not our employees; rather, they serve as either independent contractors or the primary investigators under research collaboration agreements that we have with their sponsoring academic or research institutions. Such investigators, study staff, scientists and collaborators may have other commitments that would limit their availability to us. Although our scientific advisors generally agree not to do competing work, if an actual or potential conflict of interest between their work for us and their work for another entity arises, we may lose their services. These factors could adversely affect the timing of our clinical trials, the timing of receipt and reporting of clinical data, the timing of our U.S. regulatory submissions and comparable foreign applications and our ability to conduct our current and planned clinical trials. It is also possible that some of our valuable proprietary knowledge may become publicly known through these clinical investigators and study staff or scientific advisors if they breach their confidentiality agreements with us, which would cause competitive harm to, and have an adverse effect on, our business.

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~~There~~We ~~are~~have ~~currently~~in ~~a number of companies using autologous and allogeneic CAR T-cell therapy, as well as bi- and tri-specific T-cell engager approaches to treat hematologic malignancies and solid tumors. Some of~~ the ~~approved or commonly used drugs and therapies for our current or future target diseases~~past, ~~including large B-cell lymphoma, are established~~ and ~~are~~we ~~widely accepted by physicians, patients and third party payors, and insurers and other third party payors~~ may ~~encourage~~in the ~~use of these products. Our product and our product candidates~~future, ifform ~~approved,~~or ~~may~~seek becollaborations ~~priced~~or atstrategic aalliances ~~significant premium over competitive products. Absent differentiated and compelling clinical evidence, pricing premiums may impede the adoption of our products over currently approved~~ or ~~commonly~~enter ~~used~~into ~~therapies,~~additional ~~which~~licensing ~~may adversely impact our business. In addition~~arrangements, ~~many companies are developing new therapeutics,~~ and we ~~cannot~~may ~~predict~~not ~~what~~realize the ~~standard~~benefits of ~~care~~such ~~will~~alliances ~~become~~or aslicensing ~~our product candidates continue in clinical development~~arrangements.

~~Our~~We ~~ability~~have toentered ~~enroll~~into ~~clinical~~research ~~trials~~ and~~/or~~ ~~our~~development ~~commercial~~collaborations ~~opportunities~~in ~~will~~the bepast, ~~reduced or eliminated if our competitors develop~~ and ~~commercialize products that are safer, more effective, have fewer side effects or are less expensive than any products that we~~ may ~~develop. Additionally, our commercial opportunities will be reduced or eliminated if novel upstream products or changes~~ in ~~treatment protocols reduce~~ the ~~overall incidence or prevalence of our current or~~ future ~~target diseases. Competition could result in reduced sales and pricing pressure on our product candidates~~, ifenter ~~approved~~into byadditional ~~applicable~~license ~~regulatory authorities. In addition, significant delays in the development of our product candidates could allow our competitors to bring products to market before us~~ and ~~impair~~collaboration ~~any ability to commercialize our product candidates~~arrangements. InAny ~~addition~~license agreement, ~~our~~collaboration ~~potential~~arrangement ~~future~~or ~~collaborators~~strategic ~~may~~alliance ~~decide to market and sell products~~ that ~~compete with the product candidates that~~ we ~~have~~enter ~~agreed~~into tois ~~license~~subject to ~~them~~numerous risks, which ~~could~~may ~~have~~include athe ~~material adverse effect on our future business, financial condition and results of operations.~~ following:

•the collaborator has significant discretion in determining the efforts and resources that they will apply to a program or product candidate under the collaboration;

•the collaborator could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;

•the collaborator may not commit sufficient resources to marketing and distribution of our products;

•the collaboration may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; and

Risks Related to Regulation and Legal Compliance

We are currently in ~~the first phase of~~ clinical development of our product candidates, and our future success is dependent on the successful development and regulatory approval of our product candidates and any product candidates we acquire.

We currently have no products approved for commercial sale, and wetwo ~~are in the first phase of clinical development of our~~ product candidates, ~~with IMPT-314 currently~~ in ~~Phase 1/2~~ clinical development. ~~The~~Our ~~future~~lead ~~success~~product ofcandidate, ~~our~~ronde‑cel, ~~business~~ is ~~substantially~~under ~~dependent~~evaluation onin ~~our~~the ~~ability~~pivotal toPiNACLE ~~obtain~~trial ~~regulatory~~in ~~approval for our product candidates, and any product candidates we acquire, for~~ the ~~indications~~3L+ ~~we seek~~setting, and, ~~if approved, to successfully commercialize one or more product candidates in~~ a ~~timely~~second ~~manner.~~pivotal ~~Each of our programs and product candidates will require clinical development~~trial, ~~regulatory approval~~PiNACLE-H2H, ~~obtaining~~which ~~manufacturing~~is ~~supply, capacity and expertise, building~~ a ~~commercial~~Phase ~~organization~~3 orhead‑to‑head ~~successfully~~CAR ~~outsourcing~~T‑cell ~~commercialization,~~therapy ~~substantial~~randomized ~~investment~~controlled ~~and~~trial ~~significant~~of ~~marketing~~ronde‑cel ~~efforts before we generate any revenue from product sales. We do not have any products that are approved for commercial sale, and we may never be able to develop or commercialize marketable products.~~

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for LBCL in the 2L setting, had its first patient dosed in February 2026. In addition, LYL273, our novel GCC‑targeted CAR T‑cell product candidate for the treatment of mCRC, is currently in Phase 1 clinical development. The future success of our business is substantially dependent on our ability to obtain regulatory approval for our product candidates, and any product candidates we acquire, for the indications we seek, and, if approved, to successfully commercialize one or more product candidates in a timely manner. Each of our programs and product candidates will require clinical development, regulatory approval, obtaining manufacturing supply, capacity and expertise, building a commercial organization or successfully outsourcing commercialization, substantial investment and significant marketing efforts before we generate any revenue from product sales. We do not have any products that are approved for commercial sale, and we may never be able to develop or commercialize marketable products.

We cannot commercialize product candidates in the United States without first obtaining regulatory approval for the product from the FDA; similarly, we cannot commercialize product candidates outside of the United States without obtaining regulatory approval from comparable foreign regulatory authorities. Before obtaining regulatory approvals for the commercial sale of any product candidate for a target indication, we must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA and comparable foreign regulatory authorities, that the product candidate is safe, pure and potent for use for that target indication and that the manufacturing facilities, processes and controls are adequate with respect to such product candidate to assure safety, purity and potency.

The time required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable but typically takes many years following the commencement of nonclinical studies and clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. We have not obtained regulatory approval for any product candidate, and it is possible that none of our existing product candidates or any future product candidates will ever obtain regulatory approval. Furthermore, the regulatory approval process for novel product candidates, such as T-cell product candidates and next-generation T-cell programs, can be more complex and consequently more expensive and take longer than for other, better known or extensively studied pharmaceutical or other product candidates.

Even if a product candidate were to successfully obtain approval from the FDA and comparable foreign regulatory authorities, any approval might contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, or may be subject to burdensome post-approval study or risk management requirements. If we are unable to obtain regulatory approval for one of our product candidates in one or more jurisdictions, or any approval contains significant limitations, we may not be able to obtain sufficient funding to continue the development of that product or generate revenues attributable to that product candidate. Also, any regulatory approval of our current or future product candidates, once obtained, may be withdrawn.

47Our cell therapy product candidates represent new therapeutic approaches that could result in heightened regulatory scrutiny, delays in clinical development or delays in our ability to achieve regulatory approval, commercialization or payor coverage of our product candidates.

~~Table~~Our future success is dependent on the successful development of ~~Contents~~our cell therapies in general and our development of product candidates, in particular. Because some of these programs, such as LYL273 in development for mCRC, represent a new approach to the treatment of cancer, developing and, if approved, commercializing our product candidates subject us to a number of challenges. Moreover, we cannot be sure that the manufacturing processes used in connection with our cell therapy product candidates will yield a sufficient supply of satisfactory products that are safe, pure and potent, scalable or profitable.

In addition to oversight by the FDA and by IRBs under guidelines promulgated by the NIH, clinical trials such as those that ~~product~~evaluate T cells expressing a synthetic CAR are also subject to review and oversight by an IBC. The IBC assesses the safety of the research and identifies any potential risk to public health or ~~generate~~the ~~revenues~~environment. ~~attributable~~While the NIH Guidelines are not mandatory unless the research in question is being conducted at or sponsored by institutions receiving NIH funding of recombinant or synthetic nucleic acid molecule research, many companies and other institutions not otherwise subject to ~~that~~the ~~product~~NIH ~~candidate~~Guidelines voluntarily follow them. ~~Also~~Although the FDA decides whether trials of cell therapies that involve genetic engineering may proceed, ~~any~~the ~~regulatory~~review ~~approval~~process and determinations of ~~our~~other ~~current~~reviewing bodies can impede or ~~future~~delay ~~product~~the ~~candidates,~~initiation ~~once~~of ~~obtained~~a clinical trial, ~~may~~even beif ~~withdrawn~~the FDA has reviewed the trial and approved its initiation.

Our cellular therapy product candidates represent new therapeutic approaches that could result in heightened regulatory scrutiny, delays in clinical development or delays in our inability to achieve regulatory approval, commercialization or payor coverage of our product candidates.

Our future success is dependent on the successful development of our cellular therapies in general and our development of product candidates, in particular. Because some of these programs represent a new approach to the treatment of cancer, developing and, if approved, commercializing our product candidates subject us to a number of challenges. Moreover, we cannot be sure that the manufacturing processes used in connection with our cell therapy product candidates will yield a sufficient supply of satisfactory products that are safe, pure and potent, scalable or profitable.

In addition to oversight by the FDA and by IRBs under guidelines promulgated by the NIH, clinical trials such as those that evaluate T cells expressing a synthetic CAR are also subject to review and oversight by an IBC, a local institutional committee that reviews and oversees research utilizing recombinant or synthetic nucleic acid molecules at that institution. The IBC assesses the safety of the research and identifies any potential risk to public health or the environment. While the NIH guidelines are not mandatory unless the research in question is being conducted at or sponsored by institutions receiving NIH funding of recombinant or synthetic nucleic acid molecule research, many companies and other institutions not otherwise subject to the NIH Guidelines voluntarily follow them. Although the FDA decides whether trials of cell therapies that involve genetic engineering may proceed, the review process and determinations of other reviewing bodies can impede or delay the initiation of a clinical trial, even if the FDA has reviewed the trial and approved its initiation.

Actual or perceived safety issues, including adoption of new therapeutics or novel approaches to treatment, may adversely influence the willingness of patients to participate in clinical trials, or if approved by applicable regulatory authorities, of physicians to subscribe to the novel treatment mechanics. The FDA or other comparable foreign regulatory authorities may ask for specific post-marketing requirements, and additional information informing benefits or risks of our products may emerge at any time prior to or after regulatory approval.

Physicians, hospitals and third-party payors often are slow to adopt new products, technologies and treatment practices that require additional upfront costs and training. Physicians may not be willing to undergo training to adopt this novel therapy, may decide the therapy is too complex to adopt without appropriate training or not cost-efficient and may choose not to administer the therapy. Based on these and other factors, hospitals and payors may decide that the benefits of this new therapy do not or will not outweigh its costs.57

The results of research, nonclinical studies or earlier clinical trials are not necessarily predictive of future results, initial clinical results in a clinical trial may not be predictive of future results in the same clinical trial and results in one indication may not be predictive of results to be expected for the same product candidate in another indication. If clinical trials of our product candidates fail to produce positive results or demonstrate satisfactory safety and efficacy, at the appropriate dose level or at all, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates. Any product candidate we advance into clinical trials may not have favorable results in later clinical trials or receive regulatory approval.

Success in research, nonclinical studies and early clinical trials does not ensure that later clinical trials will generate similar results and otherwise provide adequate data to demonstrate the efficacy and safety of an investigational product. Clinical trials may show that one or more of our product candidates are not safe or effective, in which event we may need to abandon development of such product candidates. In fact, a number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience than us, have suffered significant setbacks in early- and late-stage clinical trials, even after seeing promising results in earlier nonclinical studies or clinical trials. Thus, even if the results from our initial research, nonclinical activities or early clinical results appear positive, we do not know whether the current Phase 1/2 clinical trial for IMPT‑314 or subsequent clinical trials we may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market any product candidates. Although ImmPACT had licensed the dual‑targeting CD19/CD20 CAR T‑cell product candidate (IMPT‑314) from UCLA, which had presented at a conference interim Phase 1 data in 13 patients with relapsed/refractory aggressive non‑Hodgkin lymphoma treated in its single-center clinical trial, such results may not be predictive of future results in our IMPT‑314 Phase 1/2 multi-center clinical trials in patients with aggressive large B-cell lymphoma.

Moreover, final study results may not be consistent with interim study results, and results in one indication may not be predictive of results for the same product candidate in another indication. If later-stage clinical trials do not produce favorable results, our ability to achieve regulatory approval for any of our product candidates may be adversely impacted. Even if we believe that we have adequate data to support an application for regulatory approval to market any of our

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product candidates, the FDA or other regulatory authorities may not agree and may require that we conduct additional clinical trials. Additionally, even if clinical trials show promising early results, clinical trials of the same product candidate in another indication may fail to show similar results, and market acceptance of our product candidate, if approved, may be limited.

Clinical development involves a lengthy and expensive process with an uncertain outcome.

We are in the first phase of clinical development of our product candidates, with IMPT-314 in Phase 1/2 clinical development. The risk of failure of our product candidates, or any product candidates we acquire, is high. The clinical trials and manufacturing of our product candidates, or any product candidates we acquire, are, and the manufacturing and marketing of such product candidates, if approved, will be, subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to test and market our product candidates. Before obtaining regulatory approvals for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive nonclinical testing and clinical trials that our product candidates are both safe and effective for use in each target indication. In particular, because our product candidates are subject to regulation as biological products, we will need to demonstrate that they are safe, pure and potent for use in their target indications. Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use.

The clinical testing that will be required for any product candidates we choose to advance is expensive and can take many years to complete, and its outcome is inherently uncertain. The FDA may not clear the IND submissions for any planned clinical trials. Even if cleared by the FDA and initiated, we cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. Failure can occur at any time during the clinical trial process. Even if our current and planned clinical trials are completed as planned, we cannot be certain that their results will support the safety and effectiveness of our product candidates for their targeted indications or support continued clinical development of such product candidates. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through nonclinical and clinical trials.

•inability to generate sufficient nonclinical, toxicology or other in vivo or in vitro data to support the initiation of clinical trials;

•delays in sufficiently developing, characterizing or controlling a manufacturing process suitable for advanced clinical trials;

•delays in reaching agreement with the FDA or other regulatory authorities, including comparable foreign regulatory authorities, as to the design or implementation of our clinical trials;

•obtaining regulatory authorization to commence a clinical trial;

•change in our strategy, such as our recent prioritization of the IMPT‑314 product candidate and discontinuation of our LYL797, LYL845 and LYL119 programs;

•obtaining IRB approval at each trial site or positive ethics committees opinions;

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•recruiting suitable patients to participate in a clinical trial;

•having patients complete a clinical trial or return for post-treatment follow-up;

•inspections of clinical trial sites or operations by applicable regulatory authorities, or the imposition of a clinical hold;

•clinical sites, CROs or other third parties deviating from trial protocol or dropping out of a trial;

•adding a sufficient number of clinical trial sites;

•manufacturing sufficient quantities of product candidates for use in clinical trials; or

Further, a clinical trial may be suspended or terminated by us, the IRBs or ethics committees for the institutions in which such trials are being conducted, the independent Data Safety Monitoring Committee for such trial or the FDA or other regulatory authorities, including comparable foreign regulatory authorities, due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities, including comparable foreign regulatory authorities, resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authority. As a result of safety or toxicity issues that we may experience in our clinical trials, we may not continue the development of nor receive approval to market any product candidates, which could prevent us from ever generating product revenues or achieving profitability. For example, previous clinical trials utilizing CAR T cells to treat hematologic tumors have shown an increased risk of CRS and immune effector cell-associated neurotoxicity syndrome, and approved CAR T products carry a boxed warning concerning the risk of developing secondary T‑cell malignancies. A prior Phase 1 clinical trial of LYL797, a ROR1-targeted CAR T‑cell product candidate was discontinued due to a narrow therapeutic window and safety reports of pneumonitis. Adverse events may also be associated with the lymphodepletion utilized with cellular therapies. If additional adverse events or other side effects are observed in any of our clinical trials that are atypical of, or more severe than, the known side effects of similar cell therapies, we may have difficulty recruiting patients to our clinical trials, patients may drop out of our trials or we may be required to abandon those trials or our development efforts of one or more product candidates altogether. If such effects are more severe, less reversible than we expect or not reversible at all, we may decide or be required to perform additional studies or to halt or delay further clinical development of any of our product candidates, which could result in the delay or denial of regulatory approval by the FDA or other regulatory authorities.

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•regulatory authorities may withdraw or limit approvals of such products and require us to take our approved product off the market;

•regulatory authorities may require a medication guide outlining the risks of such side effects for distribution to patients, or that we implement a REMS plan or risk management plan to ensure that the benefits of the product outweigh its risks;

•we may be required to change the dose or the way the product is administered, conduct additional clinical trials or change the labeling of the product;

•we may be subject to limitations on how we may promote or manufacture the product;

•sales of the product may decrease significantly;

•we may be subject to litigation or product liability claims; and

•our reputation may suffer.

From time to time, we may publicly disclose interim, topline or preliminary data from our nonclinical studies and clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. Further, modifications or improvements to our manufacturing processes for a therapy may result in changes to the characteristics or behavior of the product candidate that could cause our product candidates to perform differently and affect the results of our ongoing clinical trials. As a result, the topline results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available.

From time to time, we may also disclose preliminary or interim data from our nonclinical studies and from our or related third party clinical trials. Preliminary or interim data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. For example, although ImmPACT had licensed the dual‑targeting CD19/CD20 CAR T‑cell product candidate (IMPT‑314) from UCLA, our IMPT‑314 Phase 1/2 clinical trials may not generate similar results or otherwise provide adequate data to demonstrate the efficacy and safety of our product candidate. Adverse differences between preliminary or interim data and final data could significantly harm our business prospects. Additionally, disclosure of preliminary or interim data by us or by our competitors could result in volatility in the price of our common stock.

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The FDA and comparable foreign regulatory approval processes are lengthy, time-consuming and inherently unpredictable. If we are not able to obtain required regulatory approvals of our product candidates, our business will be substantially harmed.

We expect the novel nature of our product candidates to create challenges in obtaining regulatory approval. For example, the FDA has limited experience with commercial development of T-cell therapies for cancer. Accordingly, the regulatory approval pathway for our product candidates may be uncertain, complex, expensive and lengthy, and approval may not be obtained.

Prior to obtaining approval to commercialize any drug product candidate in the United States or abroad, we must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that such product candidates are safe, pure and potent for their intended uses. Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if we believe the nonclinical or clinical data for our product candidates are promising, such data may not be sufficient to support approval by the FDA and other comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authorities may also require us to conduct additional nonclinical studies or clinical trials for our product candidates either prior to or after approval, or it may object to elements of our clinical development programs.

Our product candidates could fail to receive regulatory approval for many reasons, including the following:

•the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

•we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;

•the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

•we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

•the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and

•the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

Of the large number of products in development, only a small percentage successfully complete the FDA or comparable foreign regulatory approval processes and are commercialized. The lengthy approval and marketing authorization process as well as the unpredictability of clinical trial ~~results~~outcomes may result in our failing to obtain regulatory approval and marketing authorization to market our product candidates, which would significantly harm our business, financial condition, results of operations and prospects.

We could also encounter delays if physicians experience unresolved ethical issues associated with enrolling patients in clinical trials of our product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles, including treatments offered by our competitors that have obtained, or may obtain in the future, FDA approval before us in the same therapeutic areas as our product candidates. Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, or a regulatory authority concludes that the financial relationship may have affected the interpretation of the trial, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection of the marketing application we submit. Any such delay or rejection could prevent or delay us from commercializing our current or future product candidates.

If we experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenue will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may ultimately lead to the denial of regulatory approval of our product candidates.

52Even if our product candidates obtain regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved,

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Even if our product candidates obtain regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.

If the FDA or a comparable foreign regulatory authority approves any of our product candidates, the manufacturing processes, testing, labeling, packaging, distribution, import, export, adverse event reporting, storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as continued compliance with cGMPs for any clinical trials that we conduct post-approval, all of which may result in significant expense and limit our ability to commercialize such products. In addition, any regulatory approvals that we receive for our product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product if approved.

Manufacturers and manufacturers’ facilities are required to comply with extensive FDA and comparable foreign regulatory authority requirements, including ensuring that quality control and manufacturing procedures conform to cGMP regulations and requirements, as well as, for the manufacture of certain of our product candidates, the FDA’s cGTPs for the use of human cellular and tissue products to prevent the introduction, transmission or spread of communicable diseases. As such, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMPs, cGTPs and adherence to commitments made in any approved marketing application. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, quality control and distribution.

If there are changes in the application of legislation or regulatory policies, or if problems are discovered with a product or our manufacture of a product, or if we or one of our distributors, licensees or co-marketers fails to comply with regulatory requirements, the regulators could take various actions. These include issuing warning letters or untitled letters, imposing fines on us, imposing restrictions on the product or its manufacture and requiring us to recall or remove the product from the market. The regulators could also suspend or withdraw our marketing authorizations, requiring us to conduct additional clinical trials, change our product labeling or submit additional applications for marketing authorization. If any of these events occurs, our ability to sell such product may be impaired, and we may incur substantial additional expense to comply with regulatory requirements, which could materially adversely affect our business, financial condition and results of operations.

In addition, if we have any product candidate approved, our product labeling, advertising and promotion will be subject to regulatory requirements and continuing regulatory review. In the United States, the FDA and the Federal Trade Commission (FTC) strictly regulate the promotional claims that may be made about pharmaceutical products to ensure that any claims about such products are consistent with regulatory approvals, not misleading or false in any particular way and adequately substantiated by clinical data. The promotion of a drug product in a manner that is false, misleading, unsubstantiated or for unapproved (or off-label) uses may result in enforcement letters, inquiries and investigations and civil and criminal sanctions by the FDA, FTC and other regulatory authorities. In particular, a product may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling. If we receive marketing approval for a product candidate, physicians may nevertheless prescribe it to their patients in a manner that is inconsistent with the approved label. If we are found to have promoted such off-label uses, we may become subject to significant liability. The FDA and other agencies and comparable foreign regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant sanctions and may result in false claims litigation under federal and state statutes, which can lead to consent decrees, civil monetary penalties, restitution, criminal fines and imprisonment, and exclusion from participation in Medicare, Medicaid and other federal and state healthcare programs. The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The government has also required that companies enter into consent decrees and/or imposed permanent injunctions under which specified promotional conduct is changed or curtailed. Equivalent requirements and penalties are provided in the EU both at the EU level and at the national level in individual EU Member States.

If a regulatory authority discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of a product, such regulatory authority may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, a regulatory authority or enforcement authority may, among other things:

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including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, a regulatory authority or enforcement authority may, among other things:

•issue warning letters;

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•issue, or require us to issue, safety-related communications, such as safety alerts, field alerts, “Dear Doctor” letters to healthcare professionals, or import alerts;

•impose civil or criminal penalties;

•suspend, limit, vary or withdraw regulatory approval;

•suspend, vary or terminate any of our nonclinical studies and clinical trials;

•refuse to approve pending applications or supplements to approved applications submitted by us;

•impose restrictions on our operations, including closing our and our contract manufacturers’ facilities; or

•seize or detain products, refuse to permit the import or export of products, or require us to conduct a product recall.

Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our products, if approved. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our company and our operating results will be adversely affected.

Moreover, the policies of the FDA and of comparable foreign regulatory authorities may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. Further, the U.S. Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo (Loper) overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes. The Loper decision could result in additional legal challenges to regulations and guidance issued by federal agencies, including the FDA, on which we rely. Any such legal challenges, if successful, could have a material impact on our business. Additionally, the Loper decision may result in increased regulatory uncertainty, inconsistent judicial interpretations and other impacts to the agency rulemaking process, any of which could adversely impact our business and operations. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action or as a result of legal challenges, either in the United States or abroad.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

WeRonde-cel ~~may~~has ~~expend~~received ~~our~~Fast ~~limited~~Track ~~resources~~and toRMAT ~~pursue~~designations, aand ~~particular~~LYL273 ~~product~~has ~~candidate~~received orFast ~~indication~~Track ~~and~~designation, ~~fail~~from tothe ~~capitalize~~FDA, onbut ~~product~~receipt ~~candidates~~of such designations or ~~indications~~any ~~that~~other designation may benot ~~more~~actually ~~profitable~~lead to a faster development, regulatory review or ~~for~~approval ~~which~~process, ~~there~~and isdoes anot ~~greater~~assure ~~likelihood~~ultimate ofFDA ~~success~~approval.

~~Because~~The weFDA ~~have~~has ~~limited~~granted ~~financial~~Fast Track and ~~management~~RMAT ~~resources,~~designations ~~we have chosen~~ to ~~prioritize~~ronde-cel ~~our~~for ~~pipeline to focus on our most differentiated product candidates. As such, we are currently primarily focused on~~ the ~~clinical~~treatment ~~development~~ of ~~our~~relapsed ~~recently acquired product candidate IMPT-314~~ and/or ~~pre-clinical~~refractory ~~research~~aggressive ~~into novel CAR T-~~B‑cell ~~product~~lymphoma ~~candidates~~in ~~with~~the ~~new~~3L+ ~~targets that are fully-armed with multiple technologies~~settings, ~~each~~RMAT ~~designed~~designation to ~~address different barriers to effective cell therapies, including T~~ronde-~~cell~~cel ~~exhaustion,~~for ~~lack~~the treatment of ~~durable~~LBCL ~~stemness,~~in ~~as well as immune suppression within~~ the ~~hostile~~2L ~~tumor~~setting ~~microenvironment.~~and Asgranted aFast ~~result,~~Track wedesignation ~~may~~to ~~forego~~LYL273 orfor ~~delay~~the ~~pursuit~~treatment of ~~opportunities with other product candidates or for other indications for these product candidates that later prove to have greater commercial potential~~mCRC. ~~Our~~We ~~resource allocation decisions~~ may ~~cause~~seek usadditional todesignations ~~fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future development programs and product candidates~~ for ~~specific indications may not yield any commercially‑viable products. For example, before prioritizing development of~~ our ~~IMPT-314~~ product ~~candidate,~~candidates our strategy focused primarily on the development of LYL797, LYL845 and LYL119, which we discontinued following the acquisition of IMPT-314. Further, if we do not accurately evaluate the commercial potential or ~~target market~~ for aronde-cel ~~particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing~~ or ~~other~~LYL273 ~~royalty arrangements~~ in ~~cases~~other ~~in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate~~indications.

~~Additionally~~The FDA has broad discretion whether or not to grant such special designations, inso ~~connection~~even ~~with~~if ~~our~~we ~~discontinuation~~believe a particular product candidate is eligible or meets the criteria for a particular special designation, we cannot assure you that the FDA would decide to grant it. Even though we have received Fast Track and RMAT designations to develop ronde-cel for the treatment of ~~LYL797~~relapsed and/or refractory aggressive B‑cell lymphoma in the 3L+ settings, ~~LYL845~~RMAT designation to ronde-cel for the treatment of LBCL in the 2L setting and ~~LYL119~~Fast Track designation to LYL273 for the treatment of mCRC, and even if we receive Fast Track or RMAT designation for other product candidates or indications, we may ~~incur~~not ~~additional~~experience ~~costs~~a ~~associated~~faster ~~with~~development ~~termination~~process, ofreview ~~agreements~~or ~~associated~~approval ~~with~~compared ~~these~~to ~~programs~~conventional FDA procedures, ~~including~~and ~~winding~~such ~~down~~designation does not assure ultimate approval by the FDA. In addition, the FDA may withdraw Fast Track and/or RMAT designations if it believes that the designation is no longer supported by data from our ~~agreements~~clinical development program. Many product candidates that have received special FDA designations have ultimately failed to obtain approval.

54The successful commercialization of our product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies. Failure to

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~~with~~obtain ~~third-party~~or ~~providers~~maintain coverage and ~~CROs~~adequate ~~conducting~~reimbursement for our ~~clinical~~product ~~trials.~~candidates, ~~Termination~~if ofapproved, ~~these~~could ~~agreements~~limit ~~may~~our ~~result~~ability into ~~disputes~~market ~~with~~those ~~these~~products ~~service providers that may result in additional costs~~ and ~~liabilities~~decrease ~~and divert management’s attention and resources, which could harm~~ our ~~business,~~ability ~~reputation,~~to ~~overall~~generate ~~financial condition and operating results~~revenue.

IMPT-314 has received Fast Track designation from the FDA, but receipt of such designation or any other designation, such as Regenerative Medicine Advanced Therapy designation, may not actually lead to a faster development, regulatory review or approval process, and does not assure ultimate FDA approval.

The FDA has granted Fast Track designation to investigate IMPT-314 for the treatment of relapsed/refractory aggressive B‑cell lymphoma in the 3rd line and later settings, and we may seek additional Fast Track designations for our product candidates or for IMPT-314 in other indications or seek other designations, such as Regenerative Medicine Advanced Therapy (RMAT) designation, for our product candidates.

The FDA has broad discretion whether or not to grant such special designations, so even if we believe a particular product candidate is eligible or meets the criteria for a particular special designation, we cannot assure you that the FDA would decide to grant it. Even though we have received Fast Track designation to develop IMPT-314 for the treatment of relapsed/refractory aggressive B‑cell lymphoma in the 3rd line and later settings, and even if we receive Fast Track or RMAT designation for other product candidates or indications, we may not experience a faster development process, review or approval compared to conventional FDA procedures, and such designation does not assure ultimate approval by the FDA. In addition, the FDA may withdraw Fast Track or RMAT designations if it believes that the designation is no longer supported by data from our clinical development program. Many product candidates that have received special FDA designations have ultimately failed to obtain approval.

We may be subject to applicable fraud and abuse, including anti-kickback and false claims, transparency, health information privacy and security and other healthcare laws. Failure to comply with such laws, may result in substantial penalties.

We may be subject to broadly applicable healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we conduct research, market, sell and distribute any product candidates for which we obtain marketing approval. The healthcare laws that may affect us include: the federal fraud and abuse laws, including the federal anti-kickback, and false claims and civil monetary penalties laws; federal data privacy and security laws, including HIPAA; and federal transparency laws related to ownership and investment interests and payments and/or other transfers of value made to or held by physicians (including doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners) and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members. In addition, many states have similar laws and regulations that may differ from each other and federal law in significant ways, thus complicating compliance efforts. Moreover, several states require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. Additionally, some state and local laws require the registration of biopharmaceutical sales representatives in the jurisdiction. Similar requirements are applicable in foreign countries. Outside the United States, interactions between pharmaceutical companies and healthcare professionals are also governed by strict laws, such as national anti-bribery laws of European countries, national sunshine rules, regulations, industry self-regulation codes of conduct and physicians’ codes of professional conduct.

Ensuring that our operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices, including our relationships with physicians and other healthcare providers, some of whom are compensated in the form of stock options for consulting services provided, may not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, disgorgement, fines, imprisonment, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid or comparable foreign programs, additional reporting requirements and/or oversight if a corporate integrity agreement or similar agreement is executed to resolve allegations of non-compliance with these laws and the curtailment or restructuring of operations. In addition, violations may also result in reputational harm, diminished profits and lower future earnings. For additional detail on healthcare laws that may affect our business, see the section entitled “Other Healthcare Laws” in Part I, Item 1 of this Annual Report on Form 10-K.

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Changes in healthcare policies, laws and regulations may impact our ability to obtain approval for, or commercialize our product candidates, if approved.

In the United States and some foreign jurisdictions there have been, and continue to be, several legislative and regulatory changes and proposed reforms of the healthcare system in an effort to contain costs, improve quality and expand access to care. In the United States, there have been and continue to be a number of healthcare-related legislative initiatives, as well as executive, judicial and Congressional challenges and amendments to existing healthcare laws that have significantly affected, and could continue to significantly affect, the healthcare industry. For example, there have been efforts to repeal, substantially modify or invalidate some or all of the provisions of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA), some of which have been successful. Further, the Inflation Reduction Act of 2022 (the IRA), signed into law on August 16, 2022, among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in the ACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and through a newly established manufacturer discount program.

In addition, there continues to be heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S. presidential executive orders, Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under government payor programs and review the relationship between pricing and manufacturer patient programs. For example, the IRA, among other things: (i) directs HHS to negotiate the price of certain high-expenditure, single source biologics that have been on the market for at least eleven years covered under Medicare, and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” under the law (the Medicare Drug Price Negotiation Program), and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions began to take effect progressively in fiscal year 2023. On August 15, 2024, HHS announced the agreed-upon reimbursement prices of the first ten drugs that were subject to price negotiations, although the Medicare Drug Price Negotiation Program is currently subject to legal challenges. On January 17, 2025, HHS selected fifteen additional products covered under Part D for price negotiation in 2025. Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program. Further, on December 7, 2023, an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act of 1980 (Bayh-Dole Act) was announced. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights that for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework. We expect that additional U.S. federal healthcare reform measures will be adopted in the future, particularly in light of the recent U.S. Presidential and Congressional elections, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures. For additional detail on healthcare reform that may affect our business, see the section entitled “Healthcare Reform” in Part I, Item 1 of this Annual Report on Form 10-K.

The successful commercialization of our product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.

The availability and adequacy of coverage and reimbursement by governmental healthcare programs such as Medicare and Medicaid, private health insurers and other third-party payors are essential for most patients to be able to afford prescription medications such as our product candidates, assuming FDA approval. Our ability to achieve acceptable levels of coverage and reimbursement for products by governmental authorities, private health insurers and other organizations will have an effect on our ability to successfully commercialize our product candidates. Our cell therapies are novel and may require additional education and support to achieve reimbursement, if at all.

Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a payor-by-payor basis. Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that a procedure is safe, effective and medically necessary; appropriate for the specific patient; cost effective; supported by peer-reviewed medical journals; included in clinical practice guidelines; and neither cosmetic, experimental, nor investigational. Assuming we obtain coverage for our product candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. We cannot be sure that coverage and reimbursement in the United States, the EU or elsewhere will be available for our product candidates or any product that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future. Additionally, we or our collaborators may develop companion diagnostic tests for use with our product candidates. We or our collaborators will be required to fulfill applicable regulatory requirements for companion diagnostic testing and to obtain coverage and reimbursement for these tests separate and apart from the coverage and reimbursement we may seek for our product candidates.

56Similarly, a significant trend in the healthcare industry is cost containment. Governmental authorities have announced initiatives to control the cost of prescription drugs and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. In addition, HHS has been empowered to negotiate the price of certain single-source biologics that have been on the market for at least 11 years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year, up to 20 products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis. In addition, HHS imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis. If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize our current and any future product candidates that we develop, which could have an adverse effect on our operating results and our overall financial condition. For additional detail on healthcare reform that may affect our cost containment, see “Healthcare Reform” in Part I, Item 1 of this Annual Report on Form 10-K. As such, cost containment reform efforts may result in an adverse effect on our operations. Obtaining coverage and adequate reimbursement for our product candidates may be particularly difficult because of the higher prices often associated with drugs administered under the supervision of a physician. Similarly, because our product candidates will be physician-administered, separate reimbursement for the product itself may or may not be available. Instead, the administering physician may or may not be reimbursed for providing the treatment or procedure in which our product is used.

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the EU or elsewhere will be available for our product candidates or any product that we may develop, and any reimbursement that may become available may be decreased or eliminated in the future. Additionally, we or our collaborators may develop companion diagnostic tests for use with our product candidates. We or our collaborators will be required to fulfill applicable regulatory requirements for companion diagnostic testing and to obtain coverage and reimbursement for these tests separate and apart from the coverage and reimbursement we may seek for our product candidates.

Similarly, a significant trend in the healthcare industry is cost containment. Governmental authorities have announced initiatives to control the cost of prescription drugs through the use of march-in rights under the Bayh-Dole Act, and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. For additional detail on healthcare reform that may affect our cost containment, see the section entitled “Healthcare Reform” in Part I, Item 1 of this Annual Report on Form 10-K. As such, cost containment reform efforts may result in an adverse effect on our operations. Obtaining coverage and adequate reimbursement for our product candidates may be particularly difficult because of the higher prices often associated with drugs administered under the supervision of a physician. Similarly, because our product candidates will be physician-administered, separate reimbursement for the product itself may or may not be available. Instead, the administering physician may or may not be reimbursed for providing the treatment or procedure in which our product is used.

Disruptions at the FDA and other government agencies caused by funding shortages, policy changes, workforce reductions or other reasons could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including, as applicable, government budget and funding levels, statutory, regulatory and policy changes, workforce reductions, the authority’s ability to hire, train and retain key personnel and accept the payment of user fees and other events that may otherwise affect the authority’s ability to perform routine functions. Average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of the FDA and other government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies and authorities, such as the recent large-scale government workforce reductions, may also slow the time necessary for new biologics or modifications to be cleared or approved biologics to be reviewed and/or approved, which would adversely affect our business. Additionally, over the last several years, the U.S. government has shut down several times, and certain regulatory agencies, such as the FDA, have had to furlough FDA employees and stop critical activities.

If a prolonged government shutdown occurs, or if the FDA or other regulatory authorities are prevented from conducting their regular inspections, reviews or other regulatory activities for any reason, including due to workforce reductions, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.61

WeTable ~~are~~of subject to U.S. and certain foreign anti-corruption laws and regulations, export and import controls, sanctions and embargoes. We could face liability and other serious consequences for violations which can harm our business.Contents

If a prolonged government shutdown continues, or if the FDA or other regulatory authorities are prevented from conducting their regular inspections, reviews or other regulatory activities for any reason, including due to workforce reductions, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Ensuring that our operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices, including our relationships with physicians and other healthcare providers, some of whom are compensated in the form of stock options for consulting services provided, may not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, disgorgement, fines, imprisonment, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid or comparable foreign programs, additional reporting requirements and/or oversight if a corporate integrity agreement or similar agreement is executed to resolve allegations of non-compliance with these laws and the curtailment or restructuring of operations. In addition, violations may also result in reputational harm, diminished profits and lower future earnings. For additional detail on healthcare laws that may affect our business, see the section entitled “Other Laws” in Part I, Item 1 of our Annual Report on Form 10-K.

We are subject to U.S. and certain foreign anti-corruption laws and regulations, export and import controls, sanctions and embargoes. We could face liability and other serious consequences for violations, which can harm our business.

We are subject to anti-corruption laws and regulations, including the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act and other state and national anti-bribery laws in the countries in which we may conduct activities in the future. Anti-corruption laws are interpreted broadly and generally prohibit companies and their employees, agents, contractors and other third-party collaborators from offering, promising, giving or authorizing others to give anything of value, either directly or indirectly through third parties, to any person in the public or private sector to obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. We may engage third parties to develop or commercialize our product candidates or to obtain necessary permits, licenses, patent registrations and other regulatory approvals outside the United States. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors and other partners, even if we do not explicitly authorize or have actual knowledge of such activities. Any violation of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.

We are also subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations and various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls. Compliance with applicable regulatory requirements regarding the export of our products may create delays in the introduction of our products in international markets or, in some cases, prevent the export of our products to some countries altogether. Furthermore, U.S. export control laws and economic

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Treasury Department’s Office of Foreign Assets Controls. Compliance with applicable regulatory requirements regarding the export of our products may create delays in the introduction of our products in international markets or, in some cases, prevent the export of our products to some countries altogether. Furthermore, U.S. export control laws and economic sanctions prohibit the provision of certain products and services to countries, governments and persons targeted by U.S. sanctions.

There is no certainty that all of our employees, agents, partners, vendors, contractors or collaborators, ~~or those of our affiliates,~~ will comply with all applicable anti-corruption, export and import control, and sanctions laws and regulations. Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers, or our employees, the closing down of facilities, including those of our suppliers and manufacturers, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to develop or commercialize our product candidates in one or more countries as well as difficulties in manufacturing or continuing to develop our product candidates, and could materially damage our reputation, any international expansion efforts, our ability to attract and retain employees and our business, prospects, operating results and financial condition.

~~We,~~Changes ~~and~~in ~~our~~healthcare ~~partners and vendors~~policies, ~~are~~laws ~~subject to stringent~~ and ~~evolving United States and foreign laws,~~ regulations ~~and~~may ~~rules,~~impact ~~contractual~~our ~~obligations,~~ability ~~industry standards, policies and other obligations related~~ to ~~data~~obtain ~~privacy~~approval ~~and~~for, ~~security. Our actual~~ or ~~perceived~~commercialize ~~failure to comply with such obligations could lead to regulatory investigations or actions, litigation (including class action claims) and mass arbitration demands, fines and penalties, disruptions of~~ our ~~business~~product ~~operations~~candidates, ~~reputational~~if ~~harm, loss of revenue or profits and other adverse business consequences~~approved.

~~We,~~In ~~and~~the ~~our~~United ~~partners~~States and ~~vendors,~~some ~~including~~foreign ~~CROs,~~jurisdictions ~~collect,~~there ~~receive,~~have ~~store~~been, ~~process,~~and ~~generate,~~continue ~~use,~~to ~~transfer~~be, ~~disclose,~~several ~~make~~legislative ~~accessible,~~and ~~protect,~~regulatory ~~secure,~~changes ~~dispose~~and proposed reforms of, ~~transmit~~the ~~and~~healthcare ~~share~~system ~~(collectively,~~in ~~process)~~an ~~personal~~effort ~~de-identified~~to ~~data~~contain costs, improve quality and ~~other~~expand ~~sensitive~~access ~~information~~to ~~(collectively~~care. In the United States, ~~sensitive~~there ~~data)~~have inbeen ~~connection~~and ~~with~~continue ~~the~~to ~~operations~~be a number of ~~our~~healthcare-related ~~business~~legislative initiatives, ~~such~~as well as ~~storage~~executive, orjudicial ~~otherwise~~and ~~processing~~Congressional ~~sensitive~~challenges ~~data~~and amendments to ~~support~~existing ~~the~~healthcare ~~conduct~~laws ofthat ~~our~~have ~~clinical~~significantly ~~trials.~~affected, ~~These~~and ~~processing~~could ~~activities~~continue ~~subject~~to ussignificantly affect, ~~and~~the ~~our~~healthcare ~~partners~~industry. ~~and~~For ~~vendors~~example, tothere ~~various~~have ~~federal,~~been ~~state,~~efforts ~~local~~to ~~and~~repeal, ~~foreign~~substantially ~~data~~modify ~~privacy~~or ~~and~~invalidate ~~security~~some ~~laws,~~or ~~regulations,~~all ~~guidance~~of ~~and~~the ~~industry~~provisions ~~standards~~of ~~and~~the ~~are~~ACA, orsome ~~may~~of ~~become~~which ~~subject~~have tobeen ~~external~~successful. ~~and~~For ~~internal~~example, ~~privacy~~on ~~and~~July ~~security~~4, ~~policies~~2025, ~~contractual~~the ~~requirements~~OBBBA ~~and~~was ~~other~~signed ~~obligations~~into ~~relating~~law tothat ~~data~~narrowed ~~privacy~~access ~~and~~to ~~security.~~ACA Ifmarketplace weexchange ~~fail~~enrollment toand ~~comply~~declined ~~with~~to ~~applicable~~extend ~~requirements~~the ~~for~~ACA ~~processing~~enhanced ~~sensitive~~advanced ~~data,~~premium ~~including~~tax incredits ~~connection~~that ~~with~~expired at the ~~development~~end of ~~our~~2025, ~~product candidates or otherwise~~which, oramong ifother aprovisions ~~partner~~in orthe ~~vendor~~law, ~~fails~~are anticipated to ~~comply~~reduce ~~with~~ the ~~same~~number orof ~~misuses~~Americans ~~sensitive~~with ~~data~~health weinsurance. ~~provide~~OBBBA toalso ~~it,~~is weexpected ~~may be subject~~ to ~~litigation,~~reduce ~~regulatory~~Medicaid ~~investigations,~~spending ~~enforcement~~and ~~actions,~~enrollment ~~fines~~by ~~and~~implementing ~~criminal~~work orrequirements ~~civil~~for ~~penalties~~some beneficiaries, ~~mass~~capping ~~arbitration~~state-directed ~~demands~~payments, ~~additional~~reducing ~~reporting~~federal ~~requirements~~funding and~~/or~~ ~~oversight,~~limiting ~~bans~~provider ontaxes ~~processing~~used ~~personal~~to ~~data~~fund ~~and~~the ~~orders~~program. toCongress ~~destroy~~is oralso ~~not~~considering ~~use~~proposed ~~personal~~legislation ~~data,~~intended asto ~~well~~further asreduce ~~negative~~healthcare ~~publicity,~~costs ~~reputational~~with ~~harm~~alternatives ~~and~~to ~~other~~replace ~~adverse~~the ~~business~~expired ~~consequences~~ACA subsidies.

Additional health reform measures may continue and affect our business in unknown ways, particularly given the change in administration. The current administration is pursuing policies to reduce regulations and expenditures across government, including at HHS, the FDA, the Centers for Medicare & Medicaid Services and related agencies. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. These actions and proposals include, for example: (1) reducing agency workforces; (2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives, including by improving upon the Medicare Drug Price Negotiation Program and establishing Most‑Favored‑Nation pricing for pharmaceutical products; (3) imposing tariffs on imported pharmaceutical products; and (4) as part of the Make America Healthy Again (MAHA) Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising. Additionally, as noted above, the Loper decision could result in other legal challenges to current regulations and guidance issued by federal agencies applicable to our operations, including those issued by the FDA. Congress may introduce and ultimately pass health care-related legislation that could impact the drug approval process.

We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures. For additional detail on healthcare reform that may affect our business, see the section entitled “Healthcare Reform” in Part I, Item 1 of this Annual Report on Form 10-K.

We, and our partners and vendors, are subject to stringent and evolving United States and foreign laws, regulations and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. The actual or perceived failure to comply with such obligations by us (or the partners and vendors with whom we work) could lead to regulatory investigations or actions, litigation (including class action claims) and mass arbitration demands, fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits and other adverse business consequences.

We, and our partners and vendors, including CROs, collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit and share (collectively, process) personal de-identified data

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and other sensitive information (collectively, sensitive data) in connection with the operations of our business, such as storage or otherwise processing sensitive data to support the conduct of our clinical trials. These processing activities subject us, and our partners and vendors, to various federal, state, local and foreign data privacy and security laws, regulations, guidance and industry standards and we (or the partners and vendors with whom we work) are or may become subject to external and internal privacy and security policies, contractual requirements and other obligations relating to data privacy and security. If we fail to comply with applicable requirements for processing sensitive data, including in connection with the development of our product candidates or otherwise, or if a partner or vendor fails to comply with the same or misuses sensitive data we provide to it, we may be subject to litigation, regulatory investigations, enforcement actions, fines and criminal or civil penalties, mass arbitration demands, additional reporting requirements and/or oversight, bans on processing personal data and orders to destroy or not use personal data, as well as negative publicity, reputational harm and other adverse business consequences.

In the United States, our and our partners’ and vendors’ operations are subject to numerous federal and state laws and regulations, including state data breach notification laws and federal and state data privacy laws and regulations that govern the collection, use, disclosure and protection of health information and other personal data, including information of our employees. For example, HIPAA imposes specific requirements relating to the privacy, security and transmission of individually identifiable protected health information, and we could potentially face substantial criminal or civil penalties if we knowingly receive protected health information from a HIPAA‑covered healthcare provider or research institution that has not satisfied HIPAA’s requirements for disclosure of such health information, or otherwise violate applicable HIPAA requirements related to the protection of such information. Even when HIPAA does not apply, failure to take appropriate steps to keep consumers’ personal data secure may constitute a violation of the Federal Trade Commission Act and other similar laws (e.g., wiretapping laws).

Numerous U.S. states have enacted comprehensive data privacy and security laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data. As applicable, such rights include the right to access, correct or delete certain personal data and to opt‑out of certain data processing activities, such as targeted advertising, profiling and automated decision-making. The exercise of these rights may impact our business and ability to advance our product candidates effectively. Certain states also impose more stringent requirements for processing certain personal data, including sensitive information, such as conducting data privacy impact assessments. These state laws allow for statutory fines for noncompliance. For example, the CCPA applies to personal data of consumers, business representatives and employees who are California residents and requires businesses to provide specific disclosures in privacy notices and honor requests of such individuals to exercise certain privacy rights. The CCPA provides for fines and allows private litigants affected by certain data breaches to recover significant statutory damages. Although the CCPA exempts some data processed in the context of clinical trials, the CCPA increases compliance costs and potential liability.

Similar laws are being considered in several other states, as well as at the federal and local levels, and we expect more states to pass similar laws in the future. These state laws may be more stringent or broader in scope, or offer greater individual rights, with respect to confidential, sensitive and personal data than federal, international or other state laws, and such laws may differ from each other and have potentially conflicting requirements that would make compliance challenging, require us to expend significant resources to achieve compliance and restrict our ability to process certain sensitive and personal data. Additionally, the U.S. Department of Justice issued a rule entitled Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons, which places additional restrictions on certain data transactions involving countries of concern (e.g., China, Russia, Iran) and covered individuals (i.e., individuals and entities located in or controlled by individuals or entities located in those jurisdictions) that may impact certain business activities such as vendor engagements, employment of certain individuals and investor agreements. Violations of the rule could lead to significant civil and criminal fines and penalties. The rule applies regardless of whether data is anonymized, key-coded, pseudonymized, de-identified or encrypted.

58Outside the United States, an increasing number of laws, regulations and industry standards may govern data privacy and security. For example, the EU GDPR, the UK GDPR, Australia’s Privacy Act and Canada’s Personal Information Protection and Electronic Documents Act impose strict requirements for processing personal data.

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challenging, require us to expend significant resources to achieve compliance and restrict our ability to process certain sensitive and personal data.

Outside the United States, an increasing number of laws, regulations and industry standards may govern data privacy and security. For example, the EU GDPR and the UK GDPR impose strict requirements for processing personal data.

Any clinical trial programs, including related regulatory filings, and research collaborations that we engage in outside the United States in the future may implicate international laws and regulations concerning data privacy and security, including those governing various aspects of clinical research in the EU and the UK.

In addition to data privacy and security laws, we are or may become contractually subject to industry standards adopted by industry groups. We are also bound by other contractual obligations related to data privacy and security, and our efforts to comply with such obligations may not be successful. Our employees and personnel use ~~generative artificial intelligence (~~AI) technologies to perform their work, and the disclosure and use of personal data in ~~generative~~ AI technologies is subject to various data privacy laws and other privacy obligations. Governments have passed and are likely to pass additional laws regulating generative AI. Our use of this technology could result in additional compliance costs, regulatory investigations and actions and lawsuits. If we are unable to use generative AI, it could make our business less efficient and result in competitive disadvantages.

Data privacy and security laws are quickly evolving, becoming increasingly stringent, and creating uncertainty. Additionally, these laws may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. We expect that we will need to expend significant capital and other resources to ensure ongoing compliance with applicable data privacy and security laws. Claims that we have violated individuals’ privacy rights or breached our contractual obligations related to data privacy and security, even if we are not found liable, could be expensive and time‑consuming to defend and could result in negative publicity that could harm our business. Moreover, even if we take all necessary action to comply with legal and regulatory requirements, we or our partners or vendors could fail or be perceived to have failed to comply with such obligations, which could subject us to fines and penalties, as well as litigation and reputational damage. In particular, plaintiffs have become increasingly more active in bringing privacy-related claims against companies, including class action claims and mass arbitration demands. Some of these claims allow for the recovery of statutory damages on a per violation basis and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations. Any of these events could have a material adverse effect on our reputation, business or financial condition, including but not limited to delays in the development of our product candidates due to inability to process personal data or to operate in certain jurisdictions, limited ability to develop or commercialize our products, expenditure of time and resources to defend any claim or inquiry, adverse publicity or substantial changes to our planned candidate pipeline development and business operations. If we fail to keep apprised of and comply with applicable foreign, federal, state or local regulatory requirements and changes thereto, we could be subject to a range of regulatory actions that could affect our or any vendors’ or partners’ ability to seek to commercialize our product candidates. Any threatened or actual government enforcement action, or litigation when private rights of action are available, could also generate negative publicity, damage our reputation, result in liabilities, fines and adverse business consequences and require that we devote substantial resources that could otherwise be used in support of other aspects of our business.64

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and other privacy obligations. Governments have passed and are likely to pass additional laws regulating AI. Our use of this technology could result in additional compliance costs, regulatory investigations and actions and lawsuits. If we are unable to use AI, it could make our business less efficient and result in competitive disadvantages. We may use AI outputs to inform certain decisions. If the recommendations, forecasts or analyses that AI applications, including AI agents, produce or assist in producing are deficient, or inaccurate, offensive, illegal, biased or discriminatory, or otherwise harmful, we could be subject to competitive harm and potential legal liability under existing and/or future legislation or regulations, including in the United States and the EU. For example, due to inaccuracies or flaws in the inputs, outputs or logic of the AI technologies, the model could be biased and could result in decisions, or lead us to make decisions, that could bias certain individuals (or classes of individuals) and adversely impact them, such as adversely impacting their ability to obtain certain pricing, products, services or benefits.

Data privacy and security laws are quickly evolving, becoming increasingly stringent and creating uncertainty. Additionally, these laws may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. We expect that we will need to expend significant capital and other resources to ensure ongoing compliance with applicable data privacy and security laws. Claims that we have violated individuals’ privacy rights or breached our contractual obligations related to data privacy and security, even if we are not found liable, could be expensive and time‑consuming to defend and could result in negative publicity that could harm our business. Moreover, even if we take all necessary action to comply with legal and regulatory requirements, we or our partners or vendors could fail or be perceived to have failed to comply with such obligations, which could subject us to fines and penalties, as well as litigation and reputational damage. In particular, plaintiffs have become increasingly more active in bringing privacy-related claims against companies, including class action claims and mass arbitration demands. Some of these claims allow for the recovery of statutory damages on a per violation basis and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations. Any of these events could have a material adverse effect on our reputation, business or financial condition, including but not limited to delays in the development of our product candidates due to inability to process personal data or to operate in certain jurisdictions, limited ability to develop or commercialize our products, expenditure of time and resources to defend any claim or inquiry, adverse publicity or substantial changes to our planned candidate pipeline development and business operations. If we fail to keep apprised of and comply with applicable foreign, federal, state or local regulatory requirements and changes thereto, we could be subject to a range of regulatory actions that could affect our or any vendors’ or partners’ ability to seek to commercialize our product candidates. Any threatened or actual government enforcement action, or litigation when private rights of action are available, could also generate negative publicity, damage our reputation, result in liabilities, fines and adverse business consequences and require that we devote substantial resources that could otherwise be used in support of other aspects of our business.

International expansion of our business would expose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.

As part of our long-term business strategy, we may pursue international expansion, including partnering with academic and commercial testing laboratories and introducing our technology outside the United States. Doing business internationally involves a number of risks, including:

•multiple, conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;

•failure by us or our distributors to obtain regulatory approvals for the sale or use of ~~IMPT~~ronde-~~314~~cel, LYL273 or any other product candidates we may develop or acquire in various countries;

•difficulties in managing foreign operations;

•complexities associated with managing government payor systems, multiple payor-reimbursement regimes or self‑pay systems;

•logistics and regulations associated with shipping blood samples, including infrastructure conditions and transportation delays;

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•limits on our ability to penetrate international markets if our current products or any other product candidates we may develop or acquire cannot be processed by an appropriately qualified local laboratory;

•financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to foreign currency exchange rate fluctuations;

•reduced protection for intellectual property rights, or lack of them in certain jurisdictions, forcing more reliance on our trade secrets, if available;

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•natural disasters, political and economic instability, including wars, invasions, other military actions, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions; and

•failure to comply with the FCPA, including its books and records provisions and its anti‑bribery provisions, by maintaining accurate information and control over sales activities and distributors’ activities.

Further, the sale of pharmaceutical products overseas at lower prices than in the United States could adversely impact our U.S. pricing strategy and financial condition if the U.S. federal health care program adopts a Most-Favored-Nation pricing structure. As a result of such policy, we may elect not to expand our business to certain foreign countries, which would limit our market opportunity. Any of these risks, if encountered, could significantly harm our international expansion and operations and, consequently, could have a material adverse effect on our financial condition and results of operations and could adversely affect our ability to successfully implement our business strategy.

Risks Relating to Our Intellectual Property

If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates, or if the scope of the intellectual property protection is not sufficiently broad, our ability to commercialize our product candidates successfully and to compete effectively may be adversely affected.

We rely upon a combination of patents, trademarks, trade secrets and confidentiality agreements to protect the intellectual property related to our ~~technology~~technologies and product candidates. We own or possess certain intellectual property, and in-license other intellectual property ~~are~~ owned or possessed by our partners ~~and are in-licensed to us~~. When we refer to “our” technologies, inventions, patents, patent applications or other intellectual property rights, we are referring to both the rights that we own or possess as well as those that we in-license, many of which are critical to our intellectual property protection and our business. If the intellectual property that we rely on is not ~~adequately protected~~adequate, competitors may be able to use our technologies and erode or negate any competitive advantage we may have.

The patentability of inventions and the validity, enforceability and scope of patents in the ~~biotechnology~~biopharmaceutical ~~field~~industry is uncertain because it involves complex legal, scientific and factual considerations, and it has in recent years been the subject of significant litigation. Moreover, the standards applied by the ~~U.S. Patent and Trademark Office (~~USPTO) and non-U.S. patent offices in granting patents are not always applied uniformly or predictably. There is also no assurance that all potentially relevant prior art relating to our patents and patent applications is known to us or has been found in the instances where searching was done. We may be unaware of prior art that could be used to invalidate an issued patent or prevent a pending patent application from issuing as a patent. There also may be prior art of which we are aware, but which we do not believe affects the validity, enforceability or patentability of a claim of one of our patents or patent applications, which may, nonetheless, ultimately be found to affect the validity, enforceability or patentability of such claim. As a consequence of these and other factors, our patent applications may fail to result in issued patents with claims that cover our product candidates in the United States or in other countries.

Even if patents have issued or do successfully issue from patent applications, and even if these patents cover our product candidates, third parties may challenge the validity, enforceability or scope thereof, which may result in these patents being narrowed, invalidated or held to be unenforceable. No assurance can be given that if challenged, our patents would be declared by a court to be valid or enforceable. Even if unchallenged, our patents and patent applications or other intellectual property rights may not adequately protect our intellectual property, provide exclusivity for our product candidates or prevent others from designing around our claims. The possibility exists that others will develop products on an independent basis which have the same effect as our product candidates and which do not infringe our patents or other intellectual property rights, or that others will design around the claims of patents that we have had issued that cover our product candidates. If the breadth or strength of protection provided by our patents and patent applications with respect to our product candidates is threatened, it could jeopardize our ability to commercialize our product candidates and it could dissuade companies from collaborating with us.

We may also desire to seek licenses from third parties who own or have rights to intellectual property that may be useful for providing exclusivity for our product candidates, or for providing the ability to develop and commercialize a product candidate in an unrestricted manner. There is no guarantee that we will be able to obtain such licenses from third parties on commercially reasonable terms, or at all.

In addition, the USPTO and various foreign governmental or inter-governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during and after the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete, irreversible loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to enter the market, which could have a material adverse effect on our business.

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~~patent~~United ~~application~~States ~~process.~~patent ~~While~~applications ancontaining ~~inadvertent~~or ~~lapse~~that ~~can~~at inany ~~many~~time ~~cases~~contained bea ~~cured~~claim bynot ~~payment~~entitled ofto a ~~late~~priority ~~fee~~date orbefore byMarch ~~other~~16, ~~means~~2013 inare ~~accordance~~subject ~~with~~to the ~~applicable~~“first ~~rules,~~to ~~there~~file” ~~are~~system ~~situations~~implemented inby ~~which~~the ~~noncompliance~~America ~~can~~Invents ~~result~~Act in(2011). ~~abandonment~~The orfirst ~~lapse~~to file system requires us to be cognizant of the ~~patent~~time orfrom invention to filing of a patent application,. ~~resulting~~Because patent applications in ~~partial~~the orUnited ~~complete,~~States ~~irreversible~~and ~~loss~~most ofother ~~patent~~countries ~~rights~~are inconfidential ~~the~~for ~~relevant~~a ~~jurisdiction.~~period Inof ~~such~~time anafter ~~event~~filing, ~~our~~and ~~competitors~~some ~~might~~remain so until issued, we cannot be ~~able~~certain tothat ~~enter~~we or our partners were the ~~market,~~first ~~which~~to ~~could~~file ~~have~~any apatent ~~material~~application ~~adverse~~related ~~effect~~to ona ~~our~~product ~~business~~candidate.

United States patent applications containing or that at any time contained a claim not entitled to a priority date before March 16, 2013 are subject to the “first to file” system implemented by the America Invents Act (2011). The first to file system requires us to be cognizant going forward of the time from invention to filing of a patent application. Because patent applications in the United States and most other countries are confidential for a period of time after filing, and some remain so until issued, we cannot be certain that we or our partners were the first to file any patent application related to a product candidate.

In addition, our registered or unregistered trademarks or trade names may be challenged, infringed or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we view as valuable to building name recognition among potential partners and customers in our markets of interest. At times, competitors or other third parties have adopted or may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion and/or litigation. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected. Our efforts to enforce, protect or defend our proprietary rights related to trademarks may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our business, financial condition, results of operations and prospects.

The lifespans of our patents may not be sufficient to effectively protect our products and business.

Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its first nonprovisional effective filing date. Although various extensions may be available, the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired for a product, we may be open to competition from biosimilar or generic medications. In addition, although upon issuance in the United States a patent’s life can be increased based on certain delays caused by the USPTO, this increase can be reduced or eliminated based on certain delays caused by the patent applicant during patent prosecution. While the patent term of certain patents can also be extended with respect to a specific product to recapture time lost in clinical trials and regulatory review by the FDA, a patent’s life also can be shortened by a terminal disclaimer over an earlier filed patent or patent application. If we do not have sufficient patent life to protect our products, our business and results of operations will be adversely affected.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, enforcing and defending patents on all of our product candidates in all countries throughout the world would be prohibitively expensive. Our intellectual property rights in certain countries outside the United States may be less extensive than those in the United States. In addition, the laws of certain foreign countries do not protect intellectual property rights to the same extent as laws in the United States. Consequently, we and our partners may not be able to prevent third parties from practicing our inventions in countries outside the United States, or from selling or importing infringing products made using our inventions in other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection or where we do not have exclusive rights under the relevant patents to develop their own products and, further, may export otherwise-infringing products to territories where we and our partners have patent protection but where enforcement is not as strong as that in the United States. These infringing products may compete with our product candidates in jurisdictions where we or our partners have no issued patents or where we do not have exclusive rights under the relevant patents, or our patent claims and other intellectual property rights may not be effective or sufficient to prevent them from so competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals, which could make it difficult for us and our partners to stop the infringement of our patents or marketing of competing products in violation of our intellectual property rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing and could provoke third parties to assert claims against us or our partners. We or our partners may not prevail in any lawsuits that we or our licensors initiate, and even if we or our licensors are successful, the damages or other remedies awarded, if any, may not be commercially meaningful.

61Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, we or our partners may have limited remedies, which could materially diminish the value of such patent. If we or our partners are forced to grant a license to third parties with respect to any patents relevant to our

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~~initiate~~business, ~~and~~our ~~even~~competitive ifposition wemay orbe ~~our~~impaired, ~~licensors~~and ~~are~~our ~~successful~~business, ~~the~~financial ~~damages~~condition, orresults ~~other~~of ~~remedies~~operations ~~awarded,~~and ifprospects ~~any,~~ may ~~not~~ be ~~commercially~~adversely ~~meaningful~~affected.

~~Many~~We ~~countries~~may ~~have~~not ~~compulsory~~be ~~licensing~~successful ~~laws~~in ~~under~~obtaining ~~which~~or amaintaining ~~patent~~necessary ~~owner~~rights ~~may be compelled~~ to ~~grant~~product ~~licenses~~components toand ~~third~~processes ~~parties.~~for ~~In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, we or~~ our ~~partners~~development ~~may~~pipeline ~~have~~through ~~limited~~acquisitions ~~remedies,~~and ~~which~~in-licenses ~~could~~and ~~materially diminish the value of such patent. If we or our partners are forced~~ to ~~grant~~operate awithout ~~license~~infringing toon ~~third~~the ~~parties~~valid ~~with~~and ~~respect~~enforceable ~~to any~~ patents ~~relevant to our business, our competitive position may be impaired,~~ and ~~our~~other ~~business,~~proprietary ~~financial~~rights ~~condition, results~~ of ~~operations~~third ~~and prospects may be adversely affected~~parties.

IfPresently we ~~are~~have ~~sued~~rights ~~for~~to ~~infringing~~the intellectual property, through licenses from third parties and under patent applications that we own or ~~misappropriating~~will own, to develop our product candidates. Because our programs may involve additional product candidates that may require the ~~intellectual~~use ~~property~~of proprietary rights ofheld by third parties, the ~~resulting~~growth ~~litigation~~of ~~could~~our bebusiness ~~costly~~will ~~and~~likely ~~time-consuming~~depend ~~and~~in ~~could~~part ~~prevent~~on orour ~~delay~~ability ~~our~~to ~~development~~acquire, ~~and~~in-license ~~commercialization~~or ~~efforts~~use these proprietary rights.

Our ~~commercial~~product ~~success~~candidates ~~depends,~~may inalso ~~part~~require specific formulations, onmanufacturing usmethods ~~and~~or ~~our~~technologies ~~partners~~to ~~not~~work ~~infringing~~effectively ~~the~~and ~~patents~~efficiently, and ~~proprietary~~these rights ofmay ~~third~~be ~~parties.~~held ~~There~~by isothers. aWe ~~substantial~~may ~~amount~~be ofunable ~~litigation~~to ~~and~~acquire ~~other~~or ~~adversarial~~in-license ~~proceedings~~any compositions, ~~both~~methods ~~within~~of ~~and outside the United States~~use, ~~involving~~processes ~~patent~~or ~~and~~ other third-party intellectual property rights infrom ~~the~~third ~~biotechnology~~parties ~~and~~that ~~pharmaceutical~~we ~~industries,~~identify. ~~including~~We ~~patent~~may ~~infringement~~fail ~~lawsuits,~~to ~~interference~~obtain orany ~~derivation~~of ~~proceedings,~~these ~~oppositions,~~licenses ~~and~~at ~~inter~~a ~~partes~~reasonable ~~and~~cost ~~post-grant~~or ~~review~~on ~~proceedings~~reasonable ~~before~~terms; ~~the~~such ~~USPTO~~failure ~~and~~would ~~non-U.S.~~harm ~~patent~~our ~~offices~~business. ~~Numerous~~Even ~~U.S.~~if ~~and~~we ~~non-U.S.~~are ~~issued~~able ~~patents~~to ~~and~~obtain ~~pending~~a ~~patent~~license, ~~applications~~it ~~owned~~may bybe ~~third parties exist in the fields in which we are developing~~non-exclusive, ~~and~~thereby ~~may~~giving ~~develop,~~our ~~product~~competitors ~~candidates.~~access Asto the ~~biotechnology~~same ~~and~~technologies ~~pharmaceutical~~licensed ~~industries~~to ~~expand~~us. ~~and~~In ~~more~~that ~~patents are issued~~event, ~~the~~we ~~risk increases that our product candidates~~ may be ~~subject~~required to ~~claims~~expend ofsignificant ~~infringement~~time ofand ~~third~~resources ~~parties’~~to ~~patent~~develop ~~rights,~~or aslicense itreplacement ~~may~~technology. ~~not~~We ~~always~~may beneed ~~clear~~ to ~~industry~~cease ~~participants,~~use ~~including us, which patents cover various types~~ of ~~products,~~the ~~methods~~compositions ~~of making~~ or methods ofcovered ~~use. The coverage of patents is subject to interpretation~~ by ~~the~~such ~~courts,~~third-party ~~and~~intellectual ~~the~~property ~~interpretation is not always uniform or predictable~~rights.

~~Third~~The ~~parties~~licensing ~~may~~and ~~assert~~acquisition ~~infringement~~of orthird-party ~~misappropriation claims against us based on existing or future~~ intellectual property rights, ~~alleging~~is ~~that~~a wecompetitive ~~are~~area, ~~employing~~and ~~their~~companies ~~proprietary~~that ~~technology without authorization. There~~ may be ~~third-party~~more ~~patents~~established or ~~patent~~have ~~applications~~greater ~~with~~resources ~~claims~~than towe ~~materials,~~do ~~formulations,~~may ~~methods~~also ofbe ~~manufacture~~pursuing orstrategies ~~methods for treatment related~~ to ~~the~~license ~~use~~ or ~~manufacturing~~acquire ofthird-party ~~our~~intellectual ~~product~~property ~~candidates~~rights that we ~~failed~~may toconsider ~~identify.~~necessary ~~For~~or ~~example,~~attractive ~~patent~~in ~~applications~~order ~~covering~~to commercialize our product candidates ~~could~~and ~~have~~to ~~been~~operate ~~filed by others~~ without ~~our~~infringing ~~knowledge,~~on ~~since~~the ~~these~~valid ~~applications~~and ~~generally~~enforceable ~~remain~~patents ~~confidential~~and ~~for~~other ~~some~~proprietary ~~period~~rights of ~~time~~third ~~after their filing date~~parties. ~~Even~~More ~~pending~~established ~~patent~~companies ~~applications~~may ~~that~~ have ~~been published, including some of which we are aware, could be later amended in~~ a ~~manner~~competitive ~~that~~advantage ~~could~~over ~~cover~~us ~~our~~due ~~product~~to ~~candidates or~~ their ~~use or manufacture. In addition~~size, wecash ~~may~~resources ~~have~~and ~~analyzed~~greater ~~patents~~clinical ordevelopment ~~patent applications of third parties that we believe are relevant to our activities~~ and ~~believe~~commercialization that we are free to operate in relation to any of our product candidates, but our competitors may obtain issued claims, including in patents we consider to be unrelated, which may block our efforts or potentially result in any of our product candidates or our activities infringing their claimscapabilities.

If we ~~or our partners~~ are ~~sued~~unable ~~for patent infringement, we would need~~ to ~~demonstrate~~protect ~~that our product candidates, products and methods either do not infringe~~ the ~~patent~~confidentiality ~~claims~~ of ~~the~~our ~~relevant~~trade ~~patent~~secrets ~~or that the patent claims are invalid or unenforceable,~~ and weother ~~may~~proprietary ~~not be able to do this. Proving that a patent is invalid is difficult and even if we are successful in the relevant proceedings~~information, ~~we may incur substantial costs, and~~ the ~~time~~value ~~and attention~~ of our ~~management~~technology ~~and scientific personnel~~ could be ~~diverted~~adversely ~~from~~affected ~~other~~and ~~activities. If one or more claims of any issued third-party patents were held by a court of competent jurisdiction to cover aspects of~~ our ~~materials,~~business ~~formulations, methods of manufacture or methods for treatment, we~~ could be ~~forced, including by court order, to cease developing, manufacturing or commercializing the relevant product candidate until the relevant patent expired~~harmed. Alternatively, we may desire or be required to obtain a license from such third party in order to use the infringing technology and to continue developing, manufacturing or marketing the infringing product candidate. However, we may not be able to obtain any required license on commercially reasonably terms, or at all. Even if we were able to obtain a license, the rights may be nonexclusive, which could result in our competitors gaining access to the same intellectual property licensed to us. If we are unable to obtain a necessary license on commercially reasonable terms, or at all, our ability to commercialize our product candidates may be impaired or delayed, which could in turn significantly harm our business.

WeIn ~~may~~addition ~~face~~to ~~claims~~seeking ~~that~~the weprotection ~~misappropriated~~afforded ~~the~~by ~~confidential~~patents, ~~information~~we orrely on trade ~~secrets~~secret ofprotection aand ~~third~~confidentiality ~~party.~~agreements Ifto protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are ~~found~~difficult to ~~have~~enforce ~~misappropriated~~and aother ~~third-party’s~~elements ~~trade~~of ~~secrets~~our technology, wediscovery ~~may~~and bedevelopment ~~prevented~~processes ~~from~~that ~~further~~involve ~~using~~proprietary ~~these~~know-how, ~~trade~~information ~~secrets,~~or ~~which~~technology that is not covered by patents. Any disclosure to or misappropriation by third parties of our confidential proprietary information could ~~limit~~enable competitors to quickly duplicate or surpass our ~~ability~~technological achievements, including by enabling them to develop and commercialize products substantially similar to or competitive with our product candidates, thus eroding our competitive position in the market.

~~Defending~~Trade ~~against~~secrets ~~intellectual~~can ~~property~~be ~~claims~~difficult to protect. We seek to protect our proprietary, ~~regardless~~confidential oftechnology ~~their~~and ~~merit~~processes, ~~could~~in bepart, ~~costly~~by entering into confidentiality agreements and ~~time~~invention ~~consuming~~assignment agreements with our employees, ~~regardless~~consultants ofand ~~the~~outside ~~outcome.~~scientific ~~Thus~~advisors, ~~even~~contractors ifand wecollaborators. ~~were~~These agreements are designed to ~~ultimately~~protect ~~prevail,~~our orproprietary information. Although we use reasonable efforts to ~~settle~~protect ~~before~~our atrade ~~final~~secrets, ~~judgment~~our employees, ~~any~~consultants, ~~litigation~~contractors, ~~could~~or ~~burden~~outside usscientific ~~with~~advisors ~~substantial~~might ~~unanticipated~~intentionally ~~costs.~~or Ininadvertently ~~addition,~~disclose ~~litigation~~our trade secrets or ~~threatened~~confidential, ~~litigation~~proprietary ~~could~~information ~~result~~to incompetitors. ~~significant~~In ~~demands~~addition, oncompetitors ~~the~~may ~~time~~otherwise ~~and~~gain ~~attention~~access ofto our ~~management~~trade ~~team,~~secrets ~~distracting~~or ~~them~~independently ~~from~~develop ~~the~~substantially ~~pursuit~~equivalent ofinformation ~~other~~and ~~company business~~techniques. ~~During~~If ~~the~~any ~~course~~ of ~~any~~our ~~intellectual~~confidential ~~property~~proprietary ~~litigation,~~information ~~there~~were ~~could~~to be ~~public~~lawfully ~~announcements~~obtained ofor ~~the~~independently ~~results~~developed ofby ~~hearings~~a competitor, ~~rulings~~we onwould ~~motions~~have ~~and~~no ~~other~~right ~~interim~~to ~~proceedings~~prevent insuch ~~the~~competitor ~~litigation~~from ~~and~~using ~~these~~that ~~announcements~~technology ~~may~~or ~~have~~information ~~negative~~to compete with us, which could harm our competitive position.

62Enforcing a claim that a third party illegally obtained and is using any of our trade secrets is expensive and time consuming, and the outcome is unpredictable. In addition, the laws of certain foreign countries do not protect proprietary rights such as trade secrets to the same extent or in the same manner as the laws of the U.S. Misappropriation or unauthorized disclosure of our trade secrets to third parties could impair our competitive advantage in the market and could adversely affect our business, results of operations and financial condition.

If we are sued for infringing the intellectual property rights of third parties, the resulting litigation could be costly and time-consuming and could prevent or delay our development and commercialization efforts.

Our commercial success depends, in part, on us and our partners not infringing the patents and proprietary rights of third parties. There is a substantial amount of litigation and other adversarial proceedings, both within and outside the United States, involving patent and other intellectual property rights in the biopharmaceutical industry, including patent infringement lawsuits, interference or derivation proceedings, oppositions, and inter partes and post-grant review proceedings before the USPTO and non-U.S. patent offices. Numerous U.S. and non-U.S. issued patents and pending

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~~impact~~patent onapplications ~~the~~owned ~~perceived~~by ~~value~~third ofparties ~~our~~exist ~~product~~in ~~candidates, programs or intellectual property. In~~ the ~~event~~fields ofin awhich ~~successful~~we ~~intellectual~~are ~~property claim against us~~developing, weand may ~~have~~develop, toproduct ~~pay~~candidates. ~~substantial~~As ~~damages,~~the ~~including~~biopharmaceutical ~~treble~~industry ~~damages~~expands and ~~attorneys’~~more ~~fees~~patents ~~if we~~ are ~~found to have willfully infringed a patent~~issued, orthe torisk ~~redesign~~increases that our ~~infringing~~ product candidates, ~~which~~ may be ~~impossible~~subject orto ~~require~~claims ~~substantial~~of ~~time~~infringement ~~and~~of ~~monetary~~third ~~expenditure.~~parties’ Inpatent ~~addition to paying monetary damages~~rights, weas it may ~~lose~~not ~~valuable~~always ~~intellectual~~be ~~property~~clear ~~rights~~to orindustry ~~personnel~~participants, ~~and~~including ~~the parties making claims against~~ us, ~~may~~which ~~obtain~~patents ~~injunctive~~cover orvarious ~~other~~types ~~equitable~~of ~~relief~~products, ~~which~~methods ~~could~~of ~~impose~~making ~~limitations~~or onmethods ~~the conduct~~ of ~~our business~~use. WeThe ~~may~~coverage ~~also~~of ~~elect~~patents tois ~~enter~~subject ~~into license agreements in order~~ to ~~settle~~interpretation ~~patent~~by ~~infringement~~the ~~claims prior to litigation~~courts, and ~~any of these license agreements may require us to pay royalties and other fees that could be significant. As a result of all of~~ the ~~foregoing,~~interpretation ~~any~~is ~~actual~~not oralways ~~threatened~~uniform ~~intellectual property claim could prevent us from developing~~ or ~~commercializing a product candidate or force us to cease some aspect of our business operations~~predictable.

Third parties may assert infringement claims against us based on existing or future intellectual property rights, alleging that we are employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacturing of our product candidates that we failed to identify. For example, patent applications covering our product candidates could have been filed by others without our knowledge, since these applications generally remain confidential for some period of time after their filing date. Even pending patent applications that have been published, including some of which we are aware, could be later amended in a manner that could cover our product candidates or their use or manufacture. In addition, we may have analyzed patents or patent applications of third parties that we believe are relevant to our activities and believe that we are free to operate in relation to any of our product candidates, but our competitors may obtain issued claims, including in patents we consider to be unrelated, which may block our efforts or potentially result in any of our product candidates or our activities infringing their claims.

If we or our partners are sued for patent infringement, we would need to demonstrate that our product candidates, products and methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid or unenforceable, and we may not be able to do this. Proving that a patent is invalid is difficult and even if we are successful in the relevant proceedings, we may incur substantial costs, and the time and attention of our management and scientific personnel could be diverted from other activities. If one or more claims of any issued third-party patents were held by a court of competent jurisdiction to cover aspects of our materials, formulations, methods of manufacture or methods for treatment, we may have to pay substantial damages, including enhanced damages and attorneys’ fees if we are found to have willfully infringed a patent. Further, we could be forced, including by court order, to cease developing, manufacturing or commercializing the relevant product candidate until the relevant patent expired. Alternatively, we may desire or be required to obtain a license from such third party in order to use the infringing technology and to continue developing, manufacturing or marketing the infringing product candidate. However, we may not be able to obtain any required license on commercially reasonably terms, or at all. Even if we were able to obtain a license, the rights may be nonexclusive, which could result in our competitors gaining access to the same intellectual property licensed to us. If we are unable to obtain a necessary license on commercially reasonable terms, or at all, our ability to commercialize our product candidates may be impaired or delayed, which could in turn significantly harm our business.

We may face claims that we misappropriated the confidential information or trade secrets of a third party. If we are found to have misappropriated a third party’s trade secrets, we may be prevented from further using these trade secrets, which could limit our ability to develop our product candidates.

We employ individuals who were previously employed at other biopharmaceutical companies. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of third parties or such individuals’ former employers. Defending against intellectual property claims, regardless of their merit, could be costly and time consuming, regardless of the outcome. Thus, even if we were to ultimately prevail, or to settle before a final judgment, any litigation could burden us with substantial unanticipated costs. In addition, litigation or threatened litigation could result in significant demands on the time and attention of our management team, distracting them from the pursuit of other company business. During the course of any intellectual property litigation, there could be public announcements of the results of hearings, rulings on motions and other interim proceedings in the litigation and these announcements may have negative impact on the perceived value of our product candidates, programs or intellectual property. In the event of a successful intellectual property claim against us, we may have to pay substantial damages, including enhanced damages and attorneys’ fees if we are found to have willfully misappropriated third-party intellectual property. In addition to paying monetary damages, we may lose sole ownership of valuable intellectual property rights or may lose personnel, and the parties making claims against us may obtain injunctive or other equitable relief, which could impose limitations on the conduct of our business. As a result of all of the foregoing, any actual or threatened intellectual property claim could prevent us from developing or commercializing a product candidate or force us to cease some aspect of our business operations.

We have in-licensed a portion of our intellectual property from our partners and other third parties. If we breach any of our license agreements with these licensors, we could potentially lose the ability to continue the development and potential commercialization of one or more of our product candidates.

We hold rights under license agreements with our partners and other third parties. Our discovery and development ~~technology~~technologies ~~platforms~~ are built, in part, around intellectual property rights in-licensed from these licensors. Under our existing license agreements, such as the UCLA License Agreement related to our CD19/CD20 program that we assumed in connection with our acquisition of ImmPACT, we are subject to various obligations, which may include diligence obligations with respect to development and commercialization activities, payment obligations upon achievement of certain milestones and royalties on product sales. If there is any conflict, dispute, disagreement or issue of nonperformance between us and our counterparties regarding our rights or obligations under these license agreements, including any conflict, dispute or disagreement arising from our failure to satisfy diligence or payment obligations, we may be liable to pay damages and our counterparties may have a right to terminate the affected license. The termination of any license agreement with one of our licensors could adversely affect our ability to utilize the intellectual property that is subject to that license agreement in our discovery and development efforts, our ability to enter into future collaboration, licensing and/or marketing agreements for one or more affected product candidates and our ability to commercialize the affected product candidates. Furthermore, disagreements under any of these license agreements may arise, including those related to:

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license agreements, such as the UCLA License Agreement related to our CD19/CD20 program that we assumed in connection with our acquisition of ImmPACT, and our exclusive license agreement with ICT for LYL273, we are subject to various obligations, which may include diligence obligations with respect to development and commercialization activities, payment obligations upon achievement of certain milestones and royalties on product sales. If there is any conflict, dispute, disagreement or issue of nonperformance between us and our counterparties regarding our rights or obligations under these license agreements, including any conflict, dispute or disagreement arising from our failure to satisfy diligence or payment obligations, we may be liable to pay damages and our counterparties may have a right to terminate the affected license. The termination of any license agreement with one of our licensors could adversely affect our ability to utilize the intellectual property that is subject to that license agreement in our discovery and development efforts, our ability to enter into future collaboration, licensing and/or marketing agreements for one or more affected product candidates and our ability to commercialize the affected product candidates. Furthermore, disagreements under any of these license agreements may arise, including those related to:

•the scope of rights granted under the license agreement and other interpretation-related issues;

•whether and the extent to which our technology and processes may infringe on intellectual property of the licensor that is not subject to the licensing agreement;

•our right to sublicense patent and other rights to third parties under collaborative development relationships; and

•the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners.

These disagreements may harm our relationship with the partner or other licensor, which could have negative impacts on other aspects of our business.

We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses and to operate without infringing on the valid and enforceable patents and other proprietary rights of third parties.

Presently we have rights to the intellectual property, through licenses from third parties and under patent applications that we own or will own, to develop our product candidates. Because our programs may involve additional product candidates that may require the use of proprietary rights held by third parties, the growth of our business will likely depend in part on our ability to acquire, in-license or use these proprietary rights.

Our product candidates may also require specific formulations, manufacturing methods or technologies to work effectively and efficiently, and these rights may be held by others. We may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms; such failure would harm our business. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In that event, we may be required to expend significant time and resources to develop or license replacement technology. We may need to cease use of the compositions or methods covered by such third-party intellectual property rights.

The licensing and acquisition of third-party intellectual property rights is a competitive area, and companies that may be more established or have greater resources than we do may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider necessary or attractive in order to commercialize our product

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candidates and to operate without infringing on the valid and enforceable patents and other proprietary rights of third parties. More established companies may have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities.

Intellectual property discovered through government funded programs may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.

We have acquired or licensed, or may require in the future, intellectual property rights that have been generated through the use of U.S. government funding or grant. Pursuant to the Bayh-Dole Act, the U.S. government has certain rights in inventions developed with government funding. These U.S. government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive or non-exclusive licenses to any of these inventions to a third party if it determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; or (iii) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”). For example, on December 7, 2023, the Biden administration announced an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework. The U.S. government also has the right to take title to these inventions if the grant recipient fails to disclose the invention to the government or fails to file an application to register the intellectual property within specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources. In addition, the U.S. government requires that any products embodying any of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States. This preference for U.S. industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property.

We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have an adverse effect on the success of our business.

Third parties may infringe our patents or misappropriate or otherwise violate our intellectual property rights. Our patent applications cannot be enforced against third parties practicing the technology claimed in these applications unless and until a patent issues from the applications, and then only to the extent the issued claims cover the technology. In the future, we or our partners may elect to initiate legal proceedings to enforce or defend our or our partners’ intellectual property rights, to protect our or our partners’ trade secrets or to determine the validity or scope of our intellectual property rights. Any claims that we or our partners assert against perceived infringers could also provoke these parties to assert counterclaims against us or our partners alleging that we or our partners infringe their intellectual property rights or that our intellectual property rights are invalid. In patent litigation in the United States, defendant counterclaims alleging noninfringement, invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert noninfringement, invalidity or unenforceability of a patent. The outcome following legal assertions of noninfringement, unpatentability, invalidity and unenforceability is unpredictable. With respect to the validity of patent rights, for example, we cannot be certain that there is no invalidating prior art, of which we, our patent counsel and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of unpatentability, invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates. Such a loss of patent protection could have a material adverse impact on our business.

Interference, derivation or opposition proceedings provoked by third parties, brought by us or our partners, or brought by the USPTO or any non-U.S. patent authority may be necessary to determine the priority of inventions or matters of inventorship with respect to our patents or patent applications. We or our partners may also become involved in other proceedings, such as reexamination or opposition proceedings, inter partes review, post-grant review or other pre-issuance or post-grant proceedings in the USPTO or its foreign counterparts relating to our intellectual property or the intellectual property of others. Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover and protect our product candidates. An unfavorable outcome in any of these proceedings could require us or our partners to cease using the related technology and commercializing our product candidates, or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us or our partners a license on commercially reasonable terms if any license is offered at all. Even if we or our licensors obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us or our licensors. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

64Any intellectual property proceedings can be expensive and time-consuming. Our or our partners’ adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than we or our partners can. Accordingly, despite our or our partners’ efforts, we or our partners may not be able to prevent third parties from infringing upon or misappropriating our intellectual property rights, particularly in countries where the laws

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amay ~~license~~not onprotect ~~commercially~~our ~~reasonable~~rights ~~terms~~as iffully ~~any~~as ~~license~~the islaws ~~offered~~in atthe ~~all~~United States. Even if we orare ~~our~~successful ~~licensors~~in ~~obtain~~the arelevant ~~license~~proceedings, itwe may beincur ~~non-exclusive~~substantial costs, ~~thereby~~and ~~giving~~the ~~our~~time ~~competitors~~and ~~access~~attention toof ~~the~~our ~~same~~management ~~technologies~~and ~~licensed~~scientific topersonnel uscould orbe ~~our~~diverted ~~licensors~~from other activities. In addition, ifin ~~the~~an ~~breadth~~infringement orproceeding, ~~strength~~a ofcourt ~~protection~~may ~~provided~~decide bythat one or more of our patents ~~and~~is ~~patent~~invalid ~~applications~~or isunenforceable, ~~threatened~~in whole or in part, itmay ~~could~~refuse ~~dissuade~~to ~~companies~~stop the other party from ~~collaborating~~using ~~with~~the technology at issue on the grounds that our patents do not cover the technology in question and/or may require us to ~~license,~~pay ~~develop~~the orother ~~commercialize~~party ~~current~~attorneys’ fees. An adverse result in any litigation proceeding could put one or ~~future~~more ~~product~~of ~~candidates~~our patents at risk of being invalidated, held unenforceable or interpreted narrowly.

Any intellectual property proceedings can be expensive and time-consuming. Our or our partners’ adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than we or our partners can. Accordingly, despite our or our partners’ efforts, we or our partners may not be able to prevent third parties from infringing upon or misappropriating our intellectual property rights, particularly in countries where the laws may not protect our rights as fully as the laws in the United States. Even if we are successful in the relevant proceedings, we may incur substantial costs, and the time and attention of our management and scientific personnel could be diverted from other activities. In addition, in an infringement proceeding, a court may decide that one or more of our patents is invalid or unenforceable, in whole or in part, may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question and/or may require us to pay the other party attorneys’ fees. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated, held unenforceable or interpreted narrowly.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments.

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

We may in the future be subject to claims that former employees, collaborators or other third parties have an interest in our patents or other intellectual property as an inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

IfWe wemay ~~are~~be ~~unable~~subject to ~~protect~~claims ~~the~~that ~~confidentiality of~~ our ~~trade secrets and other proprietary information~~employees, ~~the~~consultants ~~value~~or ofindependent ~~our~~contractors ~~technology~~have ~~could~~breached benon-compete ~~adversely~~or ~~affected~~non-solicit ~~and our business could be harmed~~obligations.

InWe ~~addition~~employ toindividuals ~~seeking~~who ~~the~~were ~~protection~~previously ~~afforded~~employed byat ~~patents,~~other webiopharmaceutical ~~rely~~companies. onWe ~~trade~~may ~~secret~~be ~~protection~~subject ~~and confidentiality agreements~~ to ~~protect~~claims ~~proprietary~~that ~~know-how~~we ~~that~~or isour ~~not~~employees, ~~patentable~~consultants or ~~that~~independent wecontractors ~~elect~~have ~~not~~inadvertently toor ~~patent,~~otherwise ~~processes~~breached ~~for~~non-compete ~~which~~or ~~patents~~non-solicit ~~are~~obligations ~~difficult~~with respect to ~~enforce~~such ~~and~~individuals’ ~~other~~prior ~~elements~~employers. ofDealing ~~our~~with ~~technology,~~such ~~discovery~~claims and ~~development~~negotiating ~~processes~~with ~~that~~potential ~~involve~~claimants ~~proprietary~~could ~~know-how,~~result ~~information~~in orsubstantial ~~technology~~cost ~~that~~and isbe ~~not~~a ~~covered~~distraction ~~by patents. Any disclosure~~ to orour ~~misappropriation~~management byand ~~third~~employees. ~~parties~~In ofaddition, ~~our~~litigation ~~confidential~~may ~~proprietary~~be ~~information~~necessary ~~could enable competitors~~ to ~~quickly~~defend ~~duplicate~~against orthese ~~surpass~~claims, ~~our~~and ~~technological~~even ~~achievements,~~if ~~including~~we byare ~~enabling~~successful ~~them~~in todefending ~~develop~~against ~~and~~these ~~commercialize~~claims, ~~products~~such ~~substantially~~litigation ~~similar~~could toresult orin ~~competitive~~further ~~with~~costs ~~our~~to ~~product~~us ~~candidates,~~and ~~thus~~distraction ~~eroding~~to our ~~competitive~~management ~~position~~and ~~in the market~~employees.

~~Trade~~Intellectual ~~secrets~~property ~~can~~discovered bethrough ~~difficult~~government tofunded ~~protect.~~programs Wemay ~~seek~~be subject to ~~protect~~federal ~~our~~regulations ~~proprietary,~~such ~~confidential~~as ~~technology and processes,~~ “march-in” ~~part~~rights, bycertain ~~entering~~reporting ~~into~~requirements ~~confidentiality agreements~~ and ~~invention~~a ~~assignment~~preference ~~agreements~~for ~~with our employees, consultants and outside scientific advisors, contractors and collaborators~~U. ~~These agreements are designed to protect our proprietary information~~S.-based Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, or outside scientific advisors might intentionally or inadvertently disclose our trade secrets or confidential, proprietary information to competitorscompanies. InCompliance ~~addition,~~with ~~competitors~~such regulations may ~~otherwise~~limit ~~gain access to~~ our ~~trade~~exclusive ~~secrets~~rights ~~or independently develop substantially equivalent information~~ and ~~techniques.~~limit ~~If any of~~ our ~~confidential~~ability ~~proprietary information were~~ to becontract ~~lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor from using that technology or information to compete~~ with ~~us,~~non-U.S. ~~which could harm our competitive position~~manufacturers.

~~Enforcing~~We ahave ~~claim~~acquired or licensed, or may require in the future, intellectual property rights that have been generated through the use of U.S. government funding or grant. Pursuant to the Bayh-Dole Act, the U.S. government has certain rights in inventions developed with government funding. These U.S. government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive or non-exclusive licenses to any of these inventions to a third party ~~illegally~~if ~~obtained~~it ~~and~~determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is ~~using~~necessary ~~any~~to ofmeet ~~our~~public ~~trade~~health ~~secrets~~or safety needs; or (iii) government action is ~~expensive~~necessary ~~and~~to ~~time~~meet ~~consuming~~requirements for public use under federal regulations (also referred to as “march-in rights”). For example, ~~and~~on December 7, 2023, the ~~outcome~~Biden isadministration ~~unpredictable~~announced an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In ~~addition~~Rights, which for the ~~laws~~first time includes the price of ~~certain~~a ~~foreign~~product ~~countries~~as doone ~~not~~factor ~~protect~~an ~~proprietary~~agency can use when deciding to exercise march-in rights. ~~such~~While asmarch-in ~~trade~~rights ~~secrets~~have not previously been exercised, it is uncertain if that will continue under the new framework. The U.S. government also has the right to take title to these inventions if the ~~same~~grant ~~extent~~recipient fails to disclose the invention to the government or infails to file an application to register the ~~same~~intellectual ~~manner~~property aswithin specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources. In addition, the ~~laws~~U.S. government requires that any products embodying any of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States. This preference for U.S. ~~Misappropriation~~industry ormay ~~unauthorized~~be ~~disclosure~~waived by the federal agency that provided the funding if the owner or assignee of ~~our~~the ~~trade~~intellectual ~~secrets~~property can show that reasonable but unsuccessful efforts have been made to ~~third~~grant ~~parties~~licenses ~~could~~on ~~impair~~similar ~~our~~terms ~~competitive~~to ~~advantage~~potential licensees that would be likely to manufacture substantially in the ~~market~~United ~~and~~States ~~could~~or ~~adversely~~that ~~affect~~under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. industry may limit our ~~business,~~ability ~~results~~to ofcontract ~~operations~~with ~~and~~non-U.S. ~~financial~~product ~~condition~~manufacturers for products covered by such intellectual property.

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We may be subject to claims that our employees, consultants or independent contractors have breached non-compete or non-solicit obligations and/or wrongfully used or disclosed confidential information of third parties.

We have received confidential and proprietary information from third parties. In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise breached non-compete or non-solicit obligations with respect to such individuals’ prior employers, or used or disclosed confidential information of these third parties or such individuals’ former employers. Dealing with such claims and negotiating with potential claimants could result in substantial cost and be a distraction to our management and employees. In addition, litigation may be necessary to defend against these claims, and even if we are successful in defending against these claims, such litigation could result in further costs to us and distraction to our management and employees.

Risks Related to Ownership of Our Common Stock

The market price of our common stock has been, and may continue to be, volatile, which could result in substantial losses for investors.

The market price of our common stock has been, and may continue to be, volatile and may fluctuate substantially as a result of a variety of factors, many of which are beyond our control. Some of the factors that may cause the market price of our common stock to fluctuate are listed below and other factors described in this “Risk Factors” section:

•the timing and results of nonclinical studies and clinical trials for our product candidates;

•failure or discontinuation of any of our product development and research programs;

•the success of existing or new competitive product candidates or technologies;

•results of clinical trials or regulatory approvals of our competitors;

•commencement or termination of collaborations, licenses, product acquisitions or other strategic transactions relating to our product development and research programs;

•our ability to successfully manufacture our product candidates at LyFE;

•any future acquisitions, strategic investments, partnerships or alliances and the related financial terms and obligations;

•regulatory or legal developments in the United States and other countries;

•the recruitment or departure of key personnel;

•developments or disputes including those concerning patent applications, issued patents or other proprietary rights;

•labor discord or disruption, geopolitical events and tensions, social unrest, war, armed conflicts and turmoil, terrorism, political instability, acts of public violence, boycotts, hostilities and social unrest and health pandemics;

•the level of expenses related to, or changes in prioritization or the discontinuation of, any of our research programs or clinical development programs;

•actual or anticipated changes in our estimates as to our financial results or development timelines;

•whether our financial results, forecasts and development timelines meet the expectations of securities analysts or investors;

•announcement or expectation of additional financing efforts;

•sales of our common stock by us, our insiders or other stockholders;

•the volume of trading in our common stock, with lower volume making our stock more susceptible to volatility;

•changes in estimates or recommendations by securities analysts, if any, that cover our stock;

•market conditions in the biopharmaceutical industry; and

•general economic, industry and market conditions beyond our control, such as inflationary pressures, the interest rate environment, labor shortages and supply chain constraints, instability in the banking industry and other macroeconomic factors and associated economic downturn.

In recent years, stock markets in general, and the market for biopharmaceutical companies in particular, have experienced significant price and volume fluctuations that have often been unrelated or disproportionate to changes in the operating performance of the companies whose stock is experiencing those price and volume fluctuations. Broad market and industry factors have affected and may seriously affect the market price of our common stock, regardless of our actual operating performance. Following periods of such volatility in the market price of a company’s securities, securities class action litigation has often been brought against that company. Because of the potential volatility of our stock price, we may become the target of securities litigation in the future. Securities litigation could result in substantial costs and divert management’s attention and resources from our business.

Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or our products.

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issuing and servicing securities issued in any such transactions. Because our decision to issue debt or equity securities in any future offering will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of any future offerings. In February 2024, we entered into a Sales Agreement pursuant to which we may offer and sell, from time to time, up to $150.0 million in shares of our common stock. In October 2024 , in connection with the acquisition of ImmPACT, we issued 1,875,000 shares of our common stock at closing (shares reflecting the effect of the 1-for-20 reverse stock split we effected in May 2025 (the Reverse Stock Split)), as adjusted for cash payments made in lieu of fractional shares, and, in July 2025, we issued an additional 625,000 shares of our common stock in connection with the achievement of certain clinical milestones, to certain pre‑closing stockholders of ImmPACT. In July 2025, we entered into the SPA, pursuant to which in July 2025, we issued 3,753,752 shares of our common stock in the initial closing and, in March 2026, we issued an additional 1,952,360 shares of our common stock in a subsequent closing. In November 2025 we entered into the exclusive license agreement with ICT pursuant to which we issued 1,900,000 shares of our common stock and may issue up to additional 1,850,000 shares of our common stock in the future pursuant to the terms specified in the agreement. See Note 13, Stockholders’ Equity, in the accompanying notes to the audited consolidated financial statements included in Part II, Item 8, of this Annual Report on Form 10-K, for additional details regarding the terms under which we may issue additional securities pursuant to the exclusive license agreement with ICT. To the extent that we raise additional capital through the sale of equity or debt securities, including pursuant to the Sales Agreement or exclusive license agreement with ICT, your ownership interest may be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. Any such future issuance of capital stock may result in further dilution of your ownership.

The incurrence of indebtedness would result in increased fixed payment obligations and could involve restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Additionally, any future collaborations we enter into with third parties may provide capital in the near term but limit our potential cash flow and revenue in the future. If we raise additional funds through strategic partnerships, alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or our products, or grant licenses on terms unfavorable to us. Certain of the foregoing transactions may require us to obtain stockholder approval, which we may not be able to obtain.

Future acquisitions, strategic investments, partnerships or alliances could be difficult to identify and integrate, divert the attention of management, disrupt our business, dilute stockholder value and adversely affect our operating results and financial condition.

In the future, we may seek to acquire or invest in additional businesses, products or technologies that we believe could complement or expand our technologies, enhance our technical capabilities or otherwise offer growth opportunities, such as our November 2025 acquisition of the exclusive license to LYL273 from ICT. The pursuit of potential acquisitions or strategic investments may divert the attention of management and cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions or investments, whether or not such transactions are completed. In addition, we have only limited experience in acquiring or investing in other businesses, and we may not successfully identify desirable targets. Once we acquire additional businesses, we may not be able to integrate them effectively following the acquisition. Acquisitions of companies or exclusive licenses of third-party intellectual property could also result in the incurrence of debt or dilutive issuances of equity securities, as we had done in connection with the acquisition of ImmPACT and the exclusive license with ICT, as well as unfavorable accounting treatment and exposure to claims and disputes by third parties, including intellectual property claims. We also may not generate sufficient financial returns to offset the costs and expenses related to any acquisitions. In addition, if an acquired business fails to meet our expectations, our business, operating results and financial condition may suffer.

Sales of a substantial number of shares of our common stock by our existing stockholders could cause the price of our common stock to decline.

At any time, sales of a substantial number of shares of our common stock in the public market could occur, or there could be a perception in the market that the holders of a large number of shares of common stock intend to sell shares, and any such event could reduce the market price of our common stock. Substantially all of the shares of our common stock outstanding and shares issued upon the exercise of stock options outstanding under our equity incentive plans, subject to applicable securities law restrictions, may be able to be sold in the public market.

Moreover, certain holders of shares of our common stock have rights, subject to conditions, to require us to file or maintain registration statements with the SEC covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. For example, in connection with the acquisition of ImmPACT, in October 2024 we issued 1,875,000 shares of our common stock at closing (shares reflecting the effect of the Reverse Stock Split), as adjusted for cash payments made in lieu of fractional shares, and, in July 2025, we issued an additional 625,000 shares

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of our common stock in connection with the achievement of certain clinical milestones, to certain pre‑closing stockholders of ImmPACT. Additionally, in connection with the ICT License Agreement, we issued 1,900,000 shares of our common stock to ICT in November 2025. Holders of such shares of our common stock have rights, subject to conditions, to require us to file registration statements covering their shares for public sale within certain timeframes following the closing of the acquisition and the achievement of milestones, as applicable. In addition, the investors under the SPA have rights to require us to file and maintain one or more registration statements covering the shares issued or issuable to them in the private placement for public sale within certain timeframes. If any of these additional shares are sold, or if it is perceived that they will be sold, in the public market, the market price of our common stock could decline.

If securities or industry analysts do not publish research or reports about our business, or if they publish negative or neutral evaluations of our stock, the price of our stock could decline.

The trading market for our common stock relies in part on the research and reports that industry or securities analysts publish about us or our business. If one or more of the analysts covering our business initiate coverage with a neutral or sell rating or downgrade their evaluations of our stock, the price of our stock could decline. If one or more of these analysts cease to cover our stock, we could lose visibility in the market for our stock, which in turn could cause our stock price to decline.

The requirements of being a public company require our management to devote substantial time to compliance initiatives and corporate governance practices and could divert management’s attention and strain our resources.

As a public company, we incur and will continue to incur significant legal, accounting and other expenses that we did not incur as a private company. Section 404, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the rules and regulations of the SEC, the listing requirements and rules of The Nasdaq Stock Market LLC and other applicable U.S. rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. In October 2024, we acquired ImmPACT, a privately-owned clinical stage biotechnology company that was not previously subject to these requirements. In connection with our efforts to comply with the requirements of being a public company, our management and our accounting, finance and other personnel will continue to need to devote a substantial amount of time towards maintaining compliance with these requirements. These requirements have and will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, the rules and regulations applicable to us as a public company have made it more expensive for us to obtain director and officer liability insurance. We cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

If we fail to maintain proper and effective internal controls over financial reporting or identify additional material weaknesses in the future, we may not be able to accurately or timely report our financial condition or results of operations, which may significantly harm our business and the value of our common stock.

As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such internal control. Section 404 of the Sarbanes-Oxley Act (Section 404) requires that we evaluate and determine the effectiveness of our internal control over financial reporting. The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation. We and our independent auditors have previously identified a material weakness in our internal control over financial reporting, and we cannot assure you that we will not identify other material weaknesses in the future. A material weakness is a deficiency or combination of deficiencies in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our consolidated financial statements will not be prevented or detected on a timely basis.

We may not have identified all material weaknesses, and our current controls and any new controls that we develop may become inadequate because of changes in personnel or conditions in our business or otherwise. Accordingly, we cannot assure you that any future material weaknesses will not result in a material misstatement of our consolidated financial statements and/or our failure to meet our public reporting obligations. In addition, if we and/or our independent registered public accounting firm are unable to conclude that our internal control over financial reporting is effective in the future, investor confidence in the accuracy and completeness of our consolidated financial statements would be adversely affected, which could significantly harm our business and the value of our common stock. Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.

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We are a non-accelerated filer. For so long as we remain a non-accelerated filer, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404. An independent assessment of the effectiveness of our internal control over financial reporting could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal control over financial reporting could lead to financial statement restatements and require us to incur the expense of remediation.

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

We are subject to the periodic reporting requirements of the Exchange Act, and we must maintain disclosure controls and procedures designed to reasonably assure that information we must disclose in reports we file or submit under the Exchange Act is accumulated and communicated to management and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. For example, our directors or executive officers could inadvertently fail to disclose a new relationship or arrangement, causing us to fail to make a required related party transaction disclosure or identify a potential conflict of interest. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected.

Delaware law and provisions in our amended and restated certificate of incorporation and bylaws might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock.

Provisions in our amended and restated certificate of incorporation and bylaws may discourage, delay, or prevent a merger, acquisition, or other change in control that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares of our common stock. These provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. Therefore, these provisions could adversely affect the price of our common stock. Among other things, our organizational documents:

•establish that our board of directors is divided into three classes, Class I, Class II and Class III, with each class serving staggered three-year terms;

•provide that our directors may be removed only for cause;

•provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum;

•eliminate cumulative voting in the election of directors;

•authorize our board of directors to issue shares of preferred stock and determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval;

•permit stockholders to take actions only at a duly called annual or special meeting and not by unanimous written consent;

•prohibit stockholders from calling a special meeting of stockholders;

•require that stockholders give advance notice to nominate directors or submit proposals for consideration at stockholder meetings;

•authorize our board of directors, by a majority vote, to amend certain provisions of the bylaws; and

•require the affirmative vote of at least 66 2/3% or more of the outstanding shares of common stock to amend many of the provisions described above.

In addition, Section 203 of the General Corporation Law of the State of Delaware (DGCL) prohibits a publicly-held Delaware corporation from engaging in a business combination with an interested stockholder, which is generally a person which together with its affiliates owns, or within the last three years has owned, 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.

Any provision of our amended and restated certificate of incorporation, amended and restated bylaws, or Delaware law that has the effect of delaying or preventing a change in control could limit the opportunity for our ~~stockholders to receive a premium for their shares of our capital stock and could also affect the price that some investors are willing to pay for our common stock.~~

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stockholders to receive a premium for their shares of our capital stock and could also affect the price that some investors are willing to pay for our common stock.

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.

Our amended and restated certificate of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:

•any derivative action or proceeding brought on our behalf;

•any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers or other employees, or stockholders to us or our stockholders;

•any action asserting a claim arising pursuant to any provision of the DGCL or our amended and restated certificate of incorporation and bylaws; and

•any action asserting a claim governed by the internal affairs doctrine.

Furthermore, to prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated certificate of incorporation also provides that unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States ~~shall~~will be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act ~~of 1933, as amended~~. However, these provisions would not apply to suits brought to enforce a duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. Any person purchasing or otherwise acquiring or holding any interest in shares of our capital stock is deemed to have received notice of and consented to the foregoing provisions. These choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds more favorable for disputes with us or with our directors, officers, other employees or agents or our other stockholders, which may discourage such lawsuits against us and such other persons, or may result in additional expense to a stockholder seeking to bring a claim against us. Alternatively, if a court were to find this choice of forum provision inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect our business, results of operations and financial condition.

As of December 31, 2024, we are a non-accelerated filer. For so long as we remain a non-accelerated filer, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404. An independent assessment of the effectiveness of our internal control over financial reporting could detect problems that our management’s assessment might not. Undetected material weaknesses in our internal control over financial reporting could lead to financial statement restatements and require us to incur the expense of remediation.

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General Risk Factors

Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.

The market price of our common stock has been, and may continue to be, volatile, which could result in substantial losses for investors.

The market price of our common stock has been, and may continue to be, volatile and may fluctuate substantially as a result of a variety of factors, many of which are beyond our control. We recently received a letter from The Nasdaq Stock Market advising us of our non‑compliance with the minimum share price required for continued listing on Nasdaq, and that we could be subject to delisting if our common stock does not regain compliance. Some of the factors that may cause the market price of our common stock to fluctuate are listed below and other factors described in this “Risk Factors” section:

•prioritization of our product candidates;

•the timing and results of nonclinical studies and clinical trials for our product candidates;

•failure or discontinuation of any of our product development and research programs;

•the success of existing or new competitive product candidates or technologies;

•results of clinical trials or regulatory approvals of our competitors;

•commencement or termination of collaborations, licenses, product acquisitions or other strategic transactions relating to our product development and research programs;

•the failure to successfully integrate ImmPACT into our business;

•any future acquisitions, strategic investments, partnerships or alliances and the related financial terms and obligations;

•regulatory or legal developments in the United States and other countries;

•the recruitment or departure of key personnel;

•developments or disputes including those concerning patent applications, issued patents, or other proprietary rights;

•the level of expenses related to any of our research programs or clinical development programs;

•actual or anticipated changes in our estimates as to our financial results or development timelines;

•whether our financial results, forecasts and development timelines meet the expectations of securities analysts or investors;

•announcement or expectation of additional financing efforts;

•sales of our common stock by us, our insiders, or other stockholders;

•changes in estimates or recommendations by securities analysts, if any, that cover our stock;

•market conditions in the healthcare sector;

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•the other factors described in this “Risk Factors” section.

In recent years, stock markets in general, and the market for biotechnology companies in particular, have experienced significant price and volume fluctuations that have often been unrelated or disproportionate to changes in the operating performance of the companies whose stock is experiencing those price and volume fluctuations. Broad market and industry factors have affected and may seriously affect the market price of our common stock, regardless of our actual operating performance. Following periods of such volatility in the market price of a company’s securities, securities class action litigation has often been brought against that company. Because of the potential volatility of our stock price, we may become the target of securities litigation in the future. Securities litigation could result in substantial costs and divert management’s attention and resources from our business.

We may be unable to comply with the applicable continued listing requirements of The Nasdaq Global Select Market.

Our common stock is currently listed on The Nasdaq Global Select Market (Nasdaq). In order to maintain this listing, we must satisfy minimum financial and other continued listing requirements and standards, including a minimum closing bid price requirement for our common stock of $1.00 per share. In January 2025, we received a letter from The Nasdaq Stock Market advising us that for 33 consecutive trading days preceding the date of the letter, the bid price of our common stock had closed below the $1.00 per share minimum price required for continued listing on Nasdaq, and therefore we could become subject to delisting if our common stock does not meet the $1.00 minimum bid price for 10 consecutive trading days within the 180-day period following the date of the letter. We intend to actively monitor the closing bid price of our common stock and will evaluate potential actions to regain compliance with the continued listing requirements of Nasdaq, including by effecting a reverse stock split, if necessary. There can be no assurance that we will be able to regain compliance with the $1.00 minimum bid price requirement or comply with Nasdaq’s other continued listing standards.

If we are ultimately not able to maintain or timely regain compliance with Nasdaq’s continued listing requirements, our common stock will be subject to delisting. In the event that our common stock is delisted from Nasdaq and is not eligible for quotation or listing on another market or exchange, trading of our common stock could be conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our common stock, and there would likely also be a reduction in our coverage by securities analysts and the news media, which could cause the price of our common stock to decline further. A delisting could also adversely affect the market liquidity of our common stock as a result of the loss of market efficiencies associated with Nasdaq and the loss of federal preemption of state securities laws, materially adversely affect our ability to obtain financing on acceptable terms, if at all, and may result in the potential loss of confidence by investors, suppliers, partners and employees and fewer business development opportunities.

If securities or industry analysts do not publish research or reports about our business, or if they publish negative or neutral evaluations of our stock, the price of our stock could decline.

Sales of a substantial number of shares of our common stock by our existing stockholders could cause the price of our common stock to decline.

At any time, sales of a substantial number of shares of our common stock in the public market could occur, or there could be a perception in the market that the holders of a large number of shares of common stock intend to sell shares, and any such event could reduce the market price of our common stock. As of December 31, 2024, we have approximately 294,876,000 shares of common stock outstanding. Substantially all of the shares of our common stock outstanding and shares issued upon the exercise of stock options outstanding under our equity incentive plans, subject to applicable securities law restrictions, may be able to be sold in the public market.

Moreover, certain holders of shares of our common stock have rights, subject to conditions, to require us to file registration statements with the SEC covering their shares or to include their shares in registration statements that we may file for ourselves or other stockholders. For example, in connection with the acquisition of ImmPACT, we issued 37.5

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million shares of our common stock at closing and have agreed to issue 12.5 million additional shares of our common stock upon the achievement of certain clinical or regulatory milestones to certain pre‑closing stockholders of ImmPACT. Holders of such shares of our common stock have rights, subject to conditions, to require us to file registration statements covering their shares for public sale within certain timeframes following the closing of the acquisition and the achievement of milestones, as applicable. If any of these additional shares are sold, or if it is perceived that they will be sold, in the public market, the market price of our common stock could decline.

Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or our products.

We may seek additional capital through a combination of public and private equity offerings, debt financings, strategic partnerships and alliances and licensing arrangements. We, and indirectly, our stockholders, will bear the cost of issuing and servicing securities issued in any such transactions. Because our decision to issue debt or equity securities in any future offering will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of any future offerings. In February 2024, we entered into a Sales Agreement pursuant to which we may offer and sell, from time to time, up to $150.0 million in shares of our common stock. To the extent that we raise additional capital through the sale of equity or debt securities, including pursuant to the Sales Agreement, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder. Pursuant to the Merger Agreement, we have also agreed to issue additional shares of our common stock to pre-closing ImmPACT stockholders upon the achievement of certain clinical or regulatory milestones. Any such future issuance of capital stock will result in further dilution of your ownership.

We recently acquired ImmPACT and reprioritized our pipeline of product candidates. In the future, we may seek to acquire or invest in additional businesses, products or technologies that we believe could complement or expand our technology platforms, enhance our technical capabilities or otherwise offer growth opportunities. The pursuit of potential acquisitions or strategic investments may divert the attention of management and cause us to incur various expenses in identifying, investigating and pursuing suitable acquisitions or investments, whether or not such transactions are completed. In addition, we have only limited experience in acquiring or investing in other businesses, and we may not successfully identify desirable targets. Once we acquire additional businesses, we may not be able to integrate them effectively following the acquisition, including our most recent acquisition of ImmPACT. Acquisitions could also result in the incurrence of debt or dilutive issuances of equity securities, as we had done in connection with the acquisition of ImmPACT, as well as unfavorable accounting treatment and exposure to claims and disputes by third parties, including intellectual property claims. We also may not generate sufficient financial returns to offset the costs and expenses related to any acquisitions. In addition, if an acquired business fails to meet our expectations, our business, operating results and financial condition may suffer.

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and financial compliance costs and will make some activities more time-consuming and costly. For example, the rules and regulations applicable to us as a public company have made it more expensive for us to obtain director and officer liability insurance. We cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Changes in tax laws or regulations, including those that are applied adversely to us or our customers, may have a material adverse effect on our business, cash flow, financial condition, results of operations, effective tax rate or compliance costs.

New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time (including in connection with reforms under consideration or being implemented at an international level by the Organisation for Economic Co-Operation and Development (the OECD)), which could adversely affect our business operations and financial performance. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely to us, and tax authorities may disagree with tax positions that we have taken, which could, in each case, result in increased tax liabilities. For example, the Tax ~~Cuts and Jobs~~ Act, ~~of 2017 (~~the ~~Tax~~CARES Act), ~~the Coronavirus Aid, Relief,~~ and ~~Economic Security Act (~~the ~~CARES~~Inflation Reduction Act) ~~and~~of ~~the~~2022 ~~IRA~~ made many significant changes to the U.S. tax laws. For example, the Tax Act made broad and complex changes to the U.S. tax code, including, among other things, reducing the federal corporate tax rate. Additionally, beginning in 2022, the Tax Act required the capitalization of research and experimentation expenses (R&E expenses) with amortization periods over five and fifteen years pursuant to Section 174 of the UCode.S. ~~Internal~~The ~~Revenue~~OBBBA ~~Code~~restored ofthe ~~1986,~~deductibility asof ~~amended~~domestic ~~(the~~R&E ~~Code).~~expenses Ifin the ~~requirement~~year toincurred ~~capitalize~~for ~~Section 174 expenditures is not modified, it may impact our effective~~ tax ~~rate and our cash tax liability in future~~ years. ~~There~~beginning ~~have~~after ~~been~~December ~~legislative~~31, ~~proposals~~2024, tobut ~~repeal~~retained ~~or defer~~ the ~~Section 174 R&E expense~~ capitalization ~~rules,~~and ~~including~~amortization ~~legislation~~requirement ~~previously~~for ~~passed~~foreign ~~by the U.S. House of Representatives that would restore the deductibility of U.S. based~~ R&E expenses ~~but not non-U~~.S. ~~R&E expenses, but there can be no assurance that any such legislation will ultimately be enacted.~~ Future guidance from the U.S. Internal Revenue Service and other tax authorities with respect to any such tax legislation may affect us, and certain aspects of ~~the~~prior ~~Tax~~tax ~~Act~~legislation could be repealed or modified in future legislation. Changes in corporate tax rates, the realization of net deferred tax assets relating to our U.S. operations and the deductibility of expenses under ~~the~~current ~~Tax~~tax ~~Act~~law or future tax reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges in the current or future taxable years and could increase our future U.S. tax expense. The foregoing items, as well as any other future changes in tax laws (whether at the initiative of the U.S. government or international bodies, such as the OECD), could have a material adverse effect on our business, cash flow, financial condition, results of operations, effective tax rate or compliance costs.

~~Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.~~76

Under the Tax Act, as modified by the CARES Act, our net operating losses (NOLs) generated in tax years beginning after December 31, 2017 may be carried forward indefinitely, but the deductibility of such federal NOLs is limited to 80% of taxable income. There is variation in how states have responded and may continue to respond to the Tax Act and CARES Act. In addition, under Sections 382 and 383 of the Code, if a corporation undergoes an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period, the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes (such as research and development tax credits) to offset its post-change income or taxes may be limited. We may have experienced ownership changes in the past, including as a result of our initial public offering (IPO), and may experience future ownership changes as a result of subsequent shifts in our stock ownership (some of which may be outside our control). As a result, our ability to use our pre-change NOLs and tax credits to offset post-change taxable income, if any, could be subject to limitations. Similar provisions of state tax law may also apply. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. As a result, even if we attain profitability, we may be unable to use a material portion of our NOLs and tax credits.

If our information technology systems or those of third parties with whom we work, or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm and other adverse consequences.

We and the third parties with whom we work face a variety of evolving threats that could cause security incidents, including but not limited to social-engineering attacks (including through deep fakes, which are increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of

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~~advanced~~Unstable ~~persistent~~market threat intrusions), denial-of-service attacks, credential stuffing, credential harvesting, personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, attacks enhanced or facilitated by artificial intelligence, natural disasters, fire, terrorism, war, telecommunication and ~~electrical~~economic ~~failures~~conditions ~~and~~may ~~other~~have ~~similar~~serious ~~threats.~~adverse ~~Cyber-attacks,~~consequences ~~malicious~~on ~~internet-based activity, online and offline fraud and other similar activities threaten the confidentiality, integrity and availability of~~ our sensitive data and information technology systems, including those of ImmPACT we are in the process of integrating, and those of the third parties upon which we rely. Such threats are prevalent and continue to rise, are increasingly difficult to detect and come from a variety of sources, including traditional computer “hackers,” threat actors, “hacktivists,” organized criminal threat actors, personnel (such as through theft or misuse), sophisticated nation states and nation-state-supported actors. In particular, severe ransomware attacks are becoming increasingly prevalent and can lead to significant interruptions in our operations, ability to advance our programs, loss of sensitive data, reputational harm and diversion of funds. To the extent that any disruption or security breach results in a loss of or damage to our data or applications or inappropriate disclosure of confidential or proprietary information, we could incur liability, the further development of our product candidates could be delayed and our business ~~could be otherwise adversely affected. Furthermore~~, wefinancial ~~may~~condition ~~not be successful in our integration of ImmPACT’s information technology systems with ours,~~ and ~~any~~stock ~~disruptions to our operations or other similar challenges may increase our vulnerability to cybersecurity threats~~price.

~~Our~~The ~~reliance~~global oncredit ~~third~~and ~~parties~~financial ~~could~~markets ~~introduce~~have ~~new~~experienced ~~cybersecurity~~extreme ~~risks~~volatility and ~~vulnerabilities,~~disruptions (including ~~supply-chain~~as ~~attacks~~a result of tariffs and recession concerns), which included severely diminished liquidity and ~~other~~credit ~~threats~~availability, todeclines ~~our~~in ~~business~~consumer ~~operations.~~confidence, Weslower ~~rely~~economic ongrowth, ~~third-party~~high ~~service~~inflation, ~~providers~~uncertainty about economic stability and ~~technologies~~swings toin ~~operate~~unemployment ~~critical~~rates. ~~business~~The ~~systems~~financial markets and tothe ~~process~~global ~~sensitive~~economy ~~data~~may inalso abe ~~variety~~adversely affected by the impact of ~~contexts~~tariffs, ~~including,~~supply ~~without~~chain ~~limitation~~disruptions, ~~cloud-based~~labor ~~infrastructure~~shortages, ~~data~~fluctuations ~~center~~in ~~facilities~~currency exchange rates, ~~encryption~~changes ~~and~~in ~~authentication~~interest ~~technology~~rates, ~~employee~~military ~~email~~conflict, ~~clinical~~acts ~~research~~of terrorism or other geopolitical events. Sanctions imposed, and ~~development~~other actions taken, by the United States and other ~~functions.~~countries Wein response to geopolitical conflicts may also ~~rely~~adversely onimpact ~~third-party~~the ~~service~~financial ~~providers~~markets toand ~~provide~~the ~~other~~global ~~products~~economy, ~~services~~and orany ~~otherwise~~economic tocountermeasures ~~operate~~by ~~our~~the ~~business.~~affected ~~Our~~countries ~~ability~~or toothers ~~monitor~~could ~~these~~exacerbate ~~third~~market ~~parties’~~and ~~information~~economic ~~security~~instability. ~~practices~~Deterioration isin ~~limited,~~credit and ~~these~~financial ~~third~~markets ~~parties~~and confidence in economic conditions may ~~not~~occur. ~~have~~Our ~~adequate~~general ~~information~~business ~~security~~strategy ~~measures~~may inbe ~~place.~~adversely Ifaffected ~~our~~by ~~third-party~~any ~~service~~such ~~providers~~economic ~~experience~~downturn, avolatile ~~security~~business ~~incident~~environment or ~~other~~continued ~~interruption~~unpredictable and unstable market conditions, weincluding ~~could~~disruption ~~experience~~to ~~material~~enrollment ~~adverse~~within ~~consequences.~~our ~~While~~ongoing weor ~~may~~planned betrials ~~entitled~~and our ability to ~~damages~~purchase necessary supplies on acceptable terms, if ~~our~~at ~~third-party~~all. ~~service~~If ~~providers~~the ~~fail~~current toequity ~~satisfy~~and ~~their~~credit ~~data~~markets ~~privacy~~deteriorate, it may make any necessary debt or ~~security-related~~equity ~~obligations~~financing tomore usdifficult, ~~any~~more ~~award~~costly ~~may~~and bemore ~~insufficient~~dilutive. Failure to ~~cover~~secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our ~~damages~~growth strategy, orfinancial weperformance ~~may~~and bestock ~~unable~~price and could require us to ~~recover~~delay ~~such~~or ~~award~~abandon clinical development plans. In addition, ~~supply-chain~~there ~~attacks~~is ~~have~~a ~~increased~~risk inthat ~~frequency~~one ~~and~~or ~~severity~~more of our current service providers, manufacturers and weother ~~cannot~~partners ~~guarantee~~may ~~that~~not ~~third~~survive ~~parties’~~an ~~infrastructure~~economic indownturn, ~~our~~which ~~supply~~could ~~chain~~directly oraffect our ~~third-party~~ability ~~partners’~~to ~~supply~~attain ~~chains~~our ~~have~~operating ~~not~~goals ~~been~~on ~~compromised~~schedule and on budget.

~~While~~Adverse wedevelopments ~~have~~affecting ~~implemented~~the ~~security~~financial ~~measures~~services ~~designed~~industry tocould ~~protect~~adversely ~~against~~affect ~~security incidents, we cannot assure you that~~ our ~~data~~current ~~protection efforts~~ and ~~our~~projected investment in information technology will detect all vulnerabilities on a timely basis, prevent significant breakdowns, data leakages, breaches in our systems or other cyber incidents that could have a material adverse effect upon our reputation, business, operations ~~or financial condition. For example, we have been the target of unsuccessful phishing attempts in the past~~ and ~~expect such attempts will continue in the future. If any of the events referenced were to occur and cause interruptions in~~ our operations, it could result in a material disruption of our programs, and the development of our product candidates could be delayed. In addition, the loss of clinical trial data for our product candidates could result in delays in our marketing approval efforts and significantly increase our costs to recover or reproduce the data. Furthermore, significant disruptions of our internal information technology systems or security breaches could result in the loss, misappropriation and/or unauthorized access, use or disclosure of, or the prevention of access to, confidential information (including trade secrets or other intellectual property, proprietary business information and personal data), which could result in financial, ~~legal,~~condition ~~business~~ and ~~reputational~~results ~~harm to us. For example, any such event that leads to unauthorized access, use or disclosure~~ of personal data, including personal data regarding our clinical trial patients or employees, could harm our reputation directly, compel us to comply with potentially costly federal and/or state breach notification laws and foreign law equivalents, subject us to mandatory corrective action, including expending significant resources or modifying our business practices such as our clinical trial activities, and otherwise subject us to liability under laws and regulations that protect the privacy and security of personal data, which could result in significant legal and financial exposure and reputational damages that could potentially have an adverse effect on our businessoperations. We take steps designed to detect, mitigate and remediate vulnerabilities in our information systems. However, we may not detect and remediate all such vulnerabilities, including on a timely basis. Further, we may experience delays in developing and deploying remedial measures and patches designed to address identified vulnerabilities. Vulnerabilities could be exploited and result in a security incident, and we may need to expend significant resources or modify our business activities (including our clinical trial activities) to try to protect against any security incidents.

~~Additionally~~Adverse developments that affect financial institutions, ~~certain~~such ~~data~~as ~~privacy~~events involving liquidity that are rumored or actual, have in the past and ~~security~~may ~~obligations~~in ~~require~~the usfuture lead to ~~implement~~bank failures and ~~maintain~~market-wide ~~specific~~liquidity ~~security~~problems. ~~measures~~For orexample, ~~industry-standard~~in orMarch ~~reasonable~~2023, ~~security~~Silicon ~~measures~~Valley toBank ~~protect~~(SVB) ~~our~~was ~~information~~closed ~~technology~~by ~~systems~~the California Department of Financial Protection and ~~sensitive~~Innovation, ~~data~~which orappointed tothe ~~notify~~Federal ~~relevant~~Deposit ~~stakeholders~~Insurance Corporation (FDIC) as receiver. Similarly, ~~including~~later ~~affected~~in ~~individuals~~March 2023, ~~regulators~~Signature Bank and ~~investors~~Silvergate Capital Corp. were each swept into receivership. In addition, ofon ~~security~~May ~~incidents~~1, 2023, the FDIC seized First Republic Bank and sold its assets to JPMorgan Chase & Co. ~~Such~~While ~~disclosures~~the ~~are~~U.S. ~~costly~~Department of Treasury, FDIC and Federal Reserve Board have implemented a program to provide up to $25 billion of loans to financial institutions secured by certain of such government securities held by financial institutions to mitigate the ~~disclosure~~risk of potential losses on the sale of such instruments, widespread demands for customer withdrawals or other liquidity needs of financial institutions for immediate liquidity may exceed the

Filing Compare · Lyell Immunopharma, Inc.