UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)


☒	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


☐	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 001-40287

~~IKENA ONCOLOGY~~ImageneBio, ~~INC~~Inc.

(Exact name of Registrant as specified in its ~~charter~~Charter)

Delaware	81-1697316
(State or other jurisdiction ofincorporation or organization)	(I.R.S. EmployerIdentification No.)
645 Summer Street, Suite 101Boston, MA	02210
12526 High Bluff DriveSuite 345San Diego, California	92130
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (~~857~~858) ~~273~~345-~~8343~~6265

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

Title of each class	TradingSymbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	IKNA	The Nasdaq Global Market
Common Stock, $0.001 par value	IMA	The Nasdaq Capital 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 ☐ No ☒

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

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 ☒ No ☐

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 ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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.

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. ☐

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. ☐

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. ☐

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). ☐

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The aggregate market value of the ~~voting~~Registrant's ~~and non-voting~~ common ~~equity~~stock held by non-affiliates of the Registrant, based on the closing price of the shares of common stock on June 2830, ~~2024~~2025, was $5141.37 million.

The number of shares of Registrant’s ~~Common~~voting ~~Stock~~common stock outstanding as of ~~February~~March 282, ~~2025~~2026 was 4810,~~258~~654,~~111~~281.

DOCUMENTS INCORPORATED BY REFERENCE

~~None~~Portions of the Registrant’s definitive Proxy Statement (the “Proxy Statement”) for the 2026 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission within 120 days after the conclusion of the Registrant’s fiscal year ended December 31, 2025, are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated.

Table of Contents

		Page
PART I
Item 1.	Business	1
Item 1A.	Risk Factors	22
Item 1B.	Unresolved Staff Comments	72
Item 1C.	Cybersecurity	73
Item 2.	Properties	73
Item 3.	Legal Proceedings	74
Item 4.	Mine Safety Disclosures	74
PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	75
Item 6.	Reserved	75
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	76
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	86
Item 8.	Financial Statements and Supplementary Data	86
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	86
Item 9A.	Controls and Procedures	86
Item 9B.	Other Information	87
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	87
PART III
Item 10.	Directors, Executive Officers and Corporate Governance	88
Item 11.	Executive Compensation	92
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	98
Item 13.	Certain Relationships and Related Transactions, and Director Independence	101
Item 14.	Principal Accountant Fees and Services	102
PART IV
Item 15.	Exhibits and Financial Statement Schedules	104
Item 16.	Form 10-K Summary	106
Signatures

Table of Contents


		Page
PART I
Item 1.	Business	1
Item 1A.	Risk Factors	36
Item 1B.	Unresolved Staff Comments	93
Item 1C.	Cybersecurity	93
Item 2.	Properties	94
Item 3.	Legal Proceedings	95
Item 4.	Mine Safety Disclosures	95

PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	96
Item 6.	[Reserved]	96
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	97
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	107
Item 8.	Financial Statements and Supplementary Data	107
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	107
Item 9A.	Controls and Procedures	107
Item 9B.	Other Information	109
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	109

PART III
Item 10.	Directors, Executive Officers and Corporate Governance	110
Item 11.	Executive Compensation	110
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	110
Item 13.	Certain Relationships and Related Transactions, and Director Independence	110
Item 14.	Principal Accounting Fees and Services	110

PART IV
Item 15.	Exhibits, Financial Statement Schedules	111
Item 16.	Form 10-K Summary	111

~~Summary~~Table of ~~the Material and Other Risks Associated with Our Business~~Contents

~~Our~~EXPLANATORY ~~business is subject to numerous material and other risks and uncertainties that you should be aware of in evaluating our business. These risks include, but are not limited to, the following:~~NOTE

~~Failure~~On toJuly ~~complete~~25, or2025 ~~delays~~(the in“Closing ~~completing~~Date”), the ~~proposed~~Delaware corporation formerly known as “Ikena Oncology, Inc.” (“Ikena”) completed its previously announced merger with Inmagene Biopharmaceuticals, ~~could~~a ~~materially~~privately held exempted company with limited liability incorporated and ~~adversely~~existing ~~affect~~under ~~our~~the ~~results~~laws of ~~operations~~the Cayman Islands (“Legacy Inmagene”). The transaction was completed in accordance with the terms of the Agreement and Plan of Merger, ~~business~~dated as of December 23, ~~financial~~2024 ~~results~~( the “Merger Agreement”), by and~~/or~~ ~~stock~~among ~~price~~Ikena, Insight Merger Sub I, an exempted company with limited liability incorporated and existing under the laws of the Cayman Islands and a direct, wholly owned subsidiary of Ikena (“Merger Sub I”), Insight Merger Sub II, an exempted company with limited liability incorporated and existing under the laws of the Cayman Islands and a direct, wholly owned subsidiary of Ikena (“Merger Sub II”), and Legacy Inmagene, providing for the merger of Merger Sub I with and into Legacy Inmagene, with Legacy Inmagene surviving as a wholly owned subsidiary of Ikena (such transaction, the “First Merger”), and the subsequent merger of the surviving entity of the First Merger with and into Merger Sub II, with Merger Sub II surviving as a wholly owned subsidiary of Ikena (the “Second Merger” and, together with the First Merger, the “Merger”). In addition, on July 25, 2025, Ikena changed its name from “Ikena Oncology, Inc.” to “ImageneBio, Inc.”

IfPrior weto dothe ~~not~~effective ~~successfully~~time ~~consummate~~of the ~~merger~~First orMerger ~~another~~(the ~~strategic~~“First ~~transaction~~Effective Time”), ~~our~~Ikena ~~board~~effected a 1-for-12 reverse stock split (the “Reverse Stock Split”) of ~~directors~~its ~~may~~issued ~~decide~~common tostock ~~pursue~~(“Ikena aCommon ~~dissolution~~Stock”). At the First Effective Time, (i) each ordinary share and ~~liquidation~~preferred share of ~~our~~Legacy ~~company.~~Inmagene In(each such ~~an event~~share, a “Legacy Inmagene Share”) held as treasury shares immediately prior to the ~~amount~~First ofEffective ~~cash~~Time ~~available~~were ~~for~~canceled ~~distribution~~and ceased to ~~our~~exist, ~~stockholders~~and ~~will~~no ~~depend~~consideration ~~heavily~~was ondelivered in exchange therefor, (ii) each then-outstanding Legacy Inmagene Share was converted into the ~~timing~~right to receive 0.0030510 shares of ~~such~~Ikena ~~liquidation~~Common asStock ~~well~~(such asratio, the ~~amount~~“Exchange ofRatio”) ~~cash~~and ~~that~~(iii) ~~will~~each ~~need~~then-outstanding option to bepurchase ~~reserved~~Legacy ~~for~~Inmagene ~~commitments~~Shares ~~and~~was ~~contingent~~converted ~~liabilities~~into an option to purchase Ikena Common Stock, assubject to ~~which~~adjustment weas ~~can~~set ~~give~~forth ~~you~~in nothe ~~assurance~~Merger Agreement.

WeAll ~~are~~references ~~substantially~~to ~~dependent~~common onstock, ~~our~~options ~~remaining~~to ~~employees~~purchase common stock, common stock share data, per share data, preferred shares and related information contained in the consolidated financial statements have been retrospectively adjusted to ~~facilitate~~reflect the ~~consummation~~effect of the ~~merger~~Exchange Ratio for all periods presented, including the change from ordinary shares to common stock, unless otherwise specifically indicated or the context otherwise requires.

~~Even~~Unless ifotherwise westated ~~are~~or ~~successful~~the context otherwise requires, the references in ~~completing~~this aAnnual ~~strategic~~Report ~~transaction~~to the “Company,” “we,” ~~may~~“our,” beor ~~exposed~~“us” refer to ~~other~~Inmagene ~~operational~~Biopharmaceuticals together with its consolidated subsidiaries for periods prior to the Merger and ~~financial~~to ~~risks~~ImageneBio, Inc. together with its consolidated subsidiaries for periods following the Merger; references to “Ikena” refer to Ikena Oncology, Inc. for periods prior to the Merger; references to “Legacy Inmagene” refer to Inmagene Biopharmaceuticals together with its consolidated subsidiaries for periods prior to the Merger and references to “common stock” refer to the Company’s voting common stock (unless specific reference is made to “non-voting” common stock or the context otherwise require) for periods following the Merger and to Legacy Inmagene’s ordinary shares for periods prior to the Merger.

If we do not complete the merger, we may face substantial competition for attractive counterparties for any proposed strategic transactions.

We have never paid and, other than in connection with the merger, do not intend to pay any cash dividends in the foreseeable future, so any returns will be limited to the value of our capital stock.

We may become involved in litigation, including securities class action litigation, which could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages.

We are a targeted oncology company with a limited operating history.

We have incurred significant net losses since our inception and, if we continue to progress the development of our product candidates, anticipate that we will continue to incur losses for the foreseeable future.

We have no products approved for commercial sale and have not generated any revenue from product sales.

We may require additional capital to finance our operations, which may not be available on acceptable terms, or at all. If we continue to progress the development of our product candidates and are unable to raise capital when needed or on terms acceptable to us, we would be forced to delay, reduce or eliminate some of our efforts.

Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

We have recently undertaken internal restructuring activities, and may do so again in the future. The assumptions underlying these activities may prove to be inaccurate, or we may fail to achieve the expected benefits therefrom.

If we continue to progress the development of our product candidates, we may not be able to successfully complete clinical trials for our ongoing targeted oncology program or our current product candidate.

Our lead program is focused on the development of oncology therapeutics for patients with genetically defined or biomarker-driven cancers, which is a rapidly evolving area of science, and the approach we have taken to discover and develop drugs is novel and may never lead to approved or marketable products.

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

If the market opportunities for our programs and product candidates are smaller than we estimate or if any regulatory approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability will be adversely affected, possibly materially.

We rely, and expect to continue to rely, on third parties to conduct our clinical trials as well as investigator-sponsored clinical trials of our product candidates. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed.

If we are unable to obtain and maintain patent and other intellectual property protection for our technology and product candidates or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and drugs may be impaired.

~~The~~Table ~~dual class structure~~ of ~~our common stock may limit our stockholders’ ability to influence corporate matters and may limit visibility with respect to certain transactions.~~ Contents

The material and other risks summarized above should be read together with the text of the full risk factors in the “Risk Factors” section and with the other information set forth in this Annual Report, including our consolidated financial statements and the related notes, as well as with other documents that we file with the United States Securities and Exchange Commission (“SEC”). If any such material and other risks and uncertainties actually occur, our business, prospects, financial condition and results of operations could be materially and adversely affected. The risks summarized above or described in full in the “Risk Factors” section, are not the only risks that we face. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial may also materially adversely affect our business, prospects, financial condition and results of operations.

iii

Special Note Regarding Forward-Looking Statements

This Annual Report on Form 10-K (this “Annual Report”) contains express or implied forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements involve risks, uncertainties, and other factors that may cause actual results, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. All statements, other than statements of historical facts, contained in this Annual Report ~~on Form 10-K~~, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management and expected market growth are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Forward-looking statements in this Annual Report ~~on Form 10-K~~ include, but are not limited to, statements about:

•

~~the~~our ~~timing~~strategies, ~~and~~prospects, ~~completion~~plans, ofexpectations ~~the~~or ~~proposed~~objectives ~~merger~~of ~~with~~management ~~Inmagene~~for ~~Biopharmaceuticals~~our ~~and~~future ~~the related financing~~operations;

•

~~our~~the ~~ability~~potential tobenefits ~~retain~~of ~~our~~IMG-007, ~~remaining~~including ~~employees~~as compared to ~~facilitate~~our ~~the~~competitors’ ~~consummation~~products ofand ~~the~~product ~~merger~~candidates;

•

~~the~~our ~~timing,~~ability ~~progress,~~to ~~results,~~maintain and ~~cost~~protect of our ~~current~~intellectual ~~clinical~~property ~~trials~~rights;

•

~~our~~legislative, ~~ability~~regulatory, political and ~~the~~economic ~~potential~~developments tobeyond ~~successfully manufacture~~ our ~~product~~control ~~candidates~~and ~~for~~the ~~clinical~~potential ~~trials,~~impact ~~and~~ on aour ~~larger scale, for commercial use, if approved~~business;

•

~~the~~our ~~ability~~plans and ~~willingness~~ability ofto ~~our~~raise ~~third-party~~significant ~~strategic~~additional ~~collaborators~~capital to ~~continue~~proceed ~~research~~with ~~and~~the development ~~activities~~and ~~relating~~commercialization toof ~~our~~IMG-007 and any future product candidates and to fund our continued operations;

•

~~our~~the ~~ability~~initiation, totiming ~~obtain~~and ~~funding~~potential ~~for~~of ~~our~~planned ~~operations~~or ~~necessary~~ongoing toclinical ~~complete~~trials ~~further~~for ~~development~~IMG-007, ~~and~~including ~~commercialization~~the oftiming ~~our~~for ~~product~~data ~~candidates~~readouts;

•

our ~~ability~~progress, toscope ~~obtain~~or ~~and~~timing ~~maintain~~of ~~regulatory~~the ~~approval~~development of IMG-007, including our ~~product~~plans ~~candidates~~to develop IMG-007 for additional immunological and inflammatory indications;

•

~~our~~expectations ~~ability~~surrounding tothe ~~commercialize~~potential ~~our~~safety, ~~products~~efficacy, ifand ~~approved~~regulatory and clinical progress of IMG-007 and anticipated milestones and timing therefor;

•

~~the~~our ~~pricing~~plans and ~~reimbursement~~expectations ofregarding our ~~product~~current ~~candidates,~~or iffuture ~~approved~~collaborations;

•

~~the~~our ~~implementation~~ability ofto ~~our~~successfully ~~business~~commercialize ~~model~~IMG-007, if approved, the rate and ~~strategic~~degree ~~plans~~of ~~for~~market ~~our~~acceptance ~~business~~of IMG-007 and ~~product~~the ~~candidates~~favorability of pricing regulations, reimbursement practices from third-party payors or healthcare reform initiatives in the United States and abroad;

•

~~the~~our ~~scope~~ability ~~of protection we are able~~ to ~~establish~~successfully identify and ~~maintain~~validate ~~for~~new ~~intellectual~~product ~~property~~candidates ~~rights~~or ~~covering~~additional ~~our~~indications ~~product~~for ~~candidates~~IMG-007;

•

~~estimates~~our ofplanned ~~our~~use ~~future~~of ~~expenses,~~cash ~~revenue,~~and ~~capital~~cash ~~requirements,~~equivalents and ~~our~~the ~~needs~~milestones ~~for~~we ~~additional~~expect ~~financing~~to fund with such proceeds;

•

the ~~potential~~accuracy ~~benefits~~ of ~~strategic~~our ~~collaboration~~estimates ~~agreements,~~regarding our ~~ability~~cash ~~to enter into strategic collaborations or arrangements~~runway, ~~and our ability to attract collaborators with development~~expenses, ~~regulatory~~future revenues and ~~commercialization~~capital ~~expertise~~requirements;

•

~~future~~the ~~agreements~~sufficiency ~~with~~of ~~third~~our ~~parties~~internal incontrols ~~connection~~and ~~with~~procedures ~~the~~and ~~commercialization~~our ofplans ~~product~~and ~~candidates~~ability ~~and~~to remediate any ~~other~~material ~~approved product~~weaknesses;

•

~~the size and growth potential of the markets for~~ our ~~product~~expectations ~~candidates,~~ and ~~our~~plans ~~ability~~regarding toongoing ~~serve~~legal ~~those~~proceedings ~~markets~~against us;

•

our ~~financial~~ability ~~performance;~~to recognize the benefits that may be derived from the Merger, including the commercial or market opportunity of IMG-007;

•

~~the~~developments ~~rate~~ and ~~degree~~projections ofrelating ~~market~~to ~~acceptance~~our ofcompetitors, our industry or the market opportunities for IMG-007 or any future product candidates;

~~regulatory developments in the United States and relevant foreign countries;~~iii

~~our~~Table ~~ability~~of ~~to contract with third-party suppliers and manufacturers and their ability to perform adequately;~~Contents

•

~~our~~regulatory, ~~ability~~political, toenvironmental, ~~produce~~economic ~~our~~and ~~products~~public orhealth ~~product~~developments ~~candidates with advantages~~ in ~~turnaround~~the ~~times~~United orStates ~~manufacturing~~and ~~cost~~foreign countries.; and

•

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

the impact of laws and regulations;

our use of proceeds from our offerings;

the effects of our workforce reductions, including costs related thereto;

our ability to obtain and negotiate favorable terms of any collaboration, licensing or other arrangement that may be necessary or desirable to develop our product candidates;

developments relating to our competitors and our industry;

the effect of pandemics, epidemics or any outbreak of an infectious disease, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our business operations;

the impact of global economic and political developments on our business; and

other risks and uncertainties, including those under the caption “Risk Factors.”

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Annual Report ~~on Form 10-K~~, particularly in the “Risk Factors” section, which could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments that we may make or into which we may enter.

~~You~~In ~~should~~addition, ~~read~~statements ~~this~~indicating ~~Annual~~that ~~Report~~“we onbelieve” ~~Form~~and ~~10-K~~similar statements reflect our beliefs and opinions on the ~~documents~~relevant ~~that~~subject. weThese ~~reference~~statements ~~herein~~are ~~and~~based ~~have~~upon ~~filed~~information available to us as ~~exhibits~~of ~~hereto~~the ~~completely~~date of this Annual Report, and ~~with~~while ~~the~~we ~~understanding~~believe ~~that~~such ~~our~~information ~~actual~~forms ~~future~~a ~~results~~reasonable basis for such statements, such information may be ~~materially~~limited ~~different~~or ~~from~~incomplete, ~~what~~and weour ~~expect.~~statements Weshould do not ~~assume~~be ~~any~~read ~~obligation~~ to ~~update~~indicate ~~any~~that ~~forward-looking~~we ~~statements,~~have ~~whether~~conducted asan aexhaustive ~~result~~inquiry into, or review of, ~~new~~all potentially available relevant information,. ~~future~~These ~~events~~statements orare ~~otherwise,~~inherently ~~except~~uncertain asand ~~required~~investors byare ~~law~~cautioned not to unduly rely upon these statements.

You should read this Annual Report and the documents that we reference herein and have filed or incorporated by reference as exhibits hereto completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Table of Contents

Summary of the Material and Other Risks Associated with Our Business

Our business is subject to numerous material and other risks and uncertainties that you should be aware of in evaluating our business. These risks include, but are not limited to, the following:

•

We are a clinical-stage biopharmaceutical company with a limited operating history, which may make it difficult to evaluate our current business and predict our future performance;

•

We expect to incur significant losses for the foreseeable future and may never achieve or maintain profitability;

•

We will need to obtain substantial additional funding to complete the development and any commercialization of IMG-007 and any future product candidates, which may cause dilution to our stockholders. If we are unable to raise this capital when needed, we may be forced to delay, reduce or eliminate our research and development programs or other operations;

•

Our business is entirely dependent on the success of IMG-007 for the treatment of AD and for other potential indications;

•

Clinical trials are expensive, time-consuming, difficult to design and implement, and have an uncertain outcome. Further, we may encounter substantial delays in our clinical trials;

•

Our rights to develop and commercialize IMG-007 are subject, in part, to the terms and conditions of licenses granted to us by others;

•

We rely on third parties for the manufacture of IMG-007 for preclinical and clinical development and expect to continue to do so for the foreseeable future. Our current and anticipated future dependence upon third parties for the manufacture of IMG-007 or any future product candidates increases the risk that we will not have sufficient quantities of IMG-007 or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts and could impact future profit margins;

•

If we breach our current or future licenses or other intellectual property-related agreements for IMG-007 or any future product candidates or otherwise experience disruptions to our business relationships with our current or future licensors, we could lose the ability to continue the development and commercialization of our product candidates;

•

We face substantial competition from other pharmaceutical and biotechnology companies, and our operating results may suffer if we fail to compete effectively;

•

The regulatory approval process of the United States Food and Drug Administration (“FDA”) and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable, and even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval for IMG-007 or any future product candidates, and any such regulatory approval may be for a more narrow indication than we seek;

•

Even if we receive regulatory approval of IMG-007 or any future product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with IMG-007 or any future product candidates;

•

If we are unable to obtain and maintain patent protection for IMG-007 or any future product candidates or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets;

•

We identified a material weakness in our internal control over financial reporting. If we fail to remediate this material weakness, or if we identify additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting in the future, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stock;

Table of Contents

•

The market price of our common stock is expected to be volatile;

•

We will incur costs and demands upon management as a result of complying with the laws, rules and regulations affecting public companies;

•

If we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize our product candidates or otherwise implement our business plan;

•

We do not anticipate that we will pay any cash dividends in the foreseeable future;

•

An active trading market for our common stock may not develop and our stockholders may not be able to resell their shares of common stock for a profit, if at all;

•

Future sales of shares by existing stockholders could cause our stock price to decline; and

•

If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.

The material and other risks summarized above should be read together with the text of the full risk factors in the “Risk Factors” section and with the other information set forth in this Annual Report, including our consolidated financial statements and the related notes, as well as with other documents that we file with the United States Securities and Exchange Commission. If any such material and other risks and uncertainties actually occur, our business, prospects, financial condition and results of operations could be materially and adversely affected. The risks summarized above or described in full in the “Risk Factors” section, are not the only risks that we face. Additional risks and uncertainties not currently known to us, or that we currently deem to be immaterial may also materially adversely affect our business, prospects, financial condition and results of operations.

Table of Contents

PART I

~~ITEM~~Item 1. ~~BUSINESS~~Business.

Overview

We are ~~historically~~ a ~~targeted~~clinical-stage ~~oncology~~biopharmaceutical company ~~focused on~~ developing ~~differentiated~~therapeutics ~~therapies~~ for patients inwith ~~need~~immunological, ~~that~~autoimmune ~~target~~and ~~nodes~~inflammatory ofdiseases. ~~cancer~~Our ~~growth~~lead asset, ~~spread~~IMG-007, ~~and~~is ~~therapeutic~~a ~~resistance.~~non-depleting Inanti-OX40 ~~May~~monoclonal ~~2024,~~antibody ~~after~~that anbinds ~~in-depth~~specifically ~~assessment~~to ofOX40 ~~the~~receptor ~~value~~on ~~proposition~~activated ofT ~~our~~cells ~~programs~~to ~~for~~block ~~both~~receptor ~~patients~~binding ~~and~~to ~~company~~OX40 ~~stakeholders,~~ligand we(“OX40L”). ~~announced~~IMG-007 ~~our~~is ~~intention~~being developed to ~~seek~~potentially ~~strategic~~treat ~~alternatives~~multiple ~~for~~autoimmune ~~the~~and ~~business~~inflammatory indiseases anand ~~effort~~disorders, towith ~~maximize~~initial ~~value~~evaluation ~~for~~in ~~shareholders~~atopic dermatitis (“AD”). AtIMG-007 ~~that~~includes ~~time,~~several features that we ~~discontinued~~believe ~~development~~are ofimportant, ~~IK-930~~differentiating attributes. First, ~~our~~IMG-007 ~~selective~~is ~~Hippo~~receptor-targeting, ~~pathway~~rather ~~inhibitor~~than ligand-targeting. ~~While~~Second, ~~dedicating~~IMG-007 ~~our~~is ~~efforts~~non-T ~~towards~~cell ~~this~~depleting: ~~corporate~~activated ~~strategy,~~T wecell ~~allocated~~signaling ~~resources~~is toattenuated, ~~continue~~however ~~the~~T ~~development~~cells ofare ~~our~~not ~~RAS~~killed ~~pathways~~and ~~program~~depleted. Finally, IKIMG-~~595.~~007’s IKhalf-~~595~~life is aapproximately ~~molecular~~5 ~~glue~~weeks, ~~designed~~which tomay ~~trap~~allow ~~MEK~~for patient-and ~~RAF~~physician-friendly indosing anschedules ~~inactive~~such ~~complex~~as tothose ~~more~~currently ~~completely~~being ~~inhibit~~explored ~~RAS~~in ~~signals~~our ~~than~~clinical ~~existing inhibitors~~program.

~~Following~~In aour ~~comprehensive~~Phase ~~review~~1b/2a ofclinical ~~strategic~~proof ~~options, including a variety~~ of ~~transaction~~concept ~~types, in December 2024, we announced the signing of a merger agreement~~ (~~the~~ “~~Merger Agreement~~POC”) ~~with~~trial, ~~Inmagene~~four-week ~~Biopharmaceuticals~~treatment ~~(“Inmagene”).~~with ~~The~~IMG-007 ~~transactions~~resulted ~~contemplated by the Merger Agreement are expected to close~~ in ~~mid-2025~~marked ~~(the~~clinical ~~“Closing”).~~activity ~~The~~which ~~transaction~~ was ~~approved~~sustained byup ~~the~~to ~~boards~~24 ofweeks ~~directors~~based ofon ~~both~~multiple ~~Ikena~~outcome ~~and~~measures. ~~Inmagene~~Results ~~and~~included ~~our~~54% ~~board~~ of ~~directors~~patients ~~resolved~~achieving toEASI-75 ~~recommend~~(75% ~~approval~~reduction ofin ~~the~~eczema ~~Merger~~area ~~Agreement~~ and ~~other~~severity ~~related~~index) ~~matters~~and to31% ~~our~~achieving ~~stockholders.~~EASI-90 ~~The~~(90% ~~Closing~~reduction isin ~~subject~~eczema toarea ~~approval~~and byseverity ~~our~~index) ~~stockholders,~~by asweek ~~well~~16. asIn ~~other customary closing conditions~~addition, ~~including~~durable ~~the~~inhibition ~~effectiveness~~ of aserum ~~registration~~inflammatory ~~statement~~markers ~~filed~~of ~~with~~diverse ~~the~~T ~~SEC~~helper in(“Th”) ~~connection~~cells, ~~with~~including ~~the transaction. If the merger is completed~~Th1, ~~the~~Th2 ~~combined~~and ~~company~~Th17 ~~will~~cells ~~operate~~was ~~under the name “ImageneBio, Inc~~observed.” IfIMG-007 ~~the~~demonstrated ~~merger~~a isfavorable ~~completed,~~emerging ~~the~~safety ~~business~~profile ofand ~~Inmagene~~was ~~will~~well-tolerated ~~continue~~in asthis ~~the~~study ~~business of the combined company~~ and ~~will~~all beother ~~centered~~studies ~~around~~to ~~advancing~~date. ~~Inmagene’s~~Notably, ~~lead~~no ~~product candidate~~pyrexia, ~~IMG-007~~chills, inaphthous ~~atopic~~or ~~dermatitis~~gastrointestinal ~~and~~ulcers ~~additional immunology~~ and ~~inflammatory~~no ~~indications.~~serious ~~All~~adverse ~~Ikena~~events ~~programs~~were ~~that~~observed ~~remain~~in ~~following~~any ~~the closing~~ of the ~~merger~~clinical ~~(our~~studies ~~legacy~~of ~~programs)~~IMG-007 ~~will~~conducted ~~be subject~~ to ~~contingent value rights (“CVR”s) that will be held by current Ikena investors when issued~~date.

~~Our~~OX40 ~~Lead~~signaling ~~Program:~~is IKthought to be important in driving the pathogenesis of a wide spectrum of immunological, autoimmune and inflammatory diseases beyond AD, including additional dermatological diseases, respiratory, gastrointestinal, and rheumatic diseases. While IMG-~~595~~007 is initially being developed for the treatment of AD, we believe it has the potential to grow into a ~~Dual~~“pipeline ~~MEK~~within a product” and we may explore additional indications with IMG-~~RAF~~007 ~~Inhibitor~~such as alopecia areata (“AA”), asthma, rheumatoid arthritis, and hidradenitis suppurativa, among others. A multi-country Phase 2b dose-finding AD study began in 2025; a protocol amendment has been submitted to the Food and Drug Administration (“FDA”) and Health Canada to enable dosing of patients with optimized dose exposures, with additional site expansion beyond North America expected. Topline data from the Phase 2b clinical trial is expected in 2027.

~~IK-595~~Our is a molecular glue designed to trap MEK and all three RAF isoforms in an inactive complex to more completely inhibit RAS signals than existing pathway inhibitors. In the second half of 2024, we continued to collect data from targeted patients in our ongoing Phase 1 clinical program in RAS and RAF mutant cancers. Fifty-one patients have been enrolled and treated with IK-595 in the dose escalation to date.Strategy

~~Targeting~~We are focused on developing IMG-007 as a potential best-in-class ~~the~~therapeutic ~~RAS~~for ~~Pathway~~immunological, autoimmune and ~~MEK~~inflammatory ~~Inhibition~~diseases inindications ~~Cancer~~where high unmet needs remain for substantial populations of patients. Key elements include:

•

~~The~~Continuing ~~RAS pathway is implicated in at least half a million new cancer diagnoses each year in~~ the ~~United~~advancement ~~States alone. Ten~~ of the ~~twenty~~Phase ~~most~~2b ~~common~~study ~~cancers~~of ~~worldwide~~IMG-007 ~~are associated with RAS pathway mutations, representing a major unmet need for new and innovative approaches~~ in ~~the~~AD ~~pathway.~~

•

10Using market insights and understanding of the 20current ~~Most~~and ~~Common~~future ~~Cancers~~treatment ~~Worldwide~~landscape ~~are~~to ~~Associated~~tailor ~~with~~the ~~RAS~~IMG-007 ~~Pathway~~clinical ~~Mutations~~development program to deliver a novel therapeutic to address the needs of patients and physicians and to eventually support payor coverage and reimbursement

•

~~Cox.~~Expanding ~~Nature~~IMG-007’s ~~Reviews~~application ~~Drug~~beyond ~~Discovery~~AD ~~(2014);~~into ~~World~~other ~~Cancer Research Fund International~~indications.

IMG-007: Clinical stage anti-OX40 monoclonal antibody for immunological, autoimmune and inflammatory diseases autoimmune diseases and disorders

OX40 as an emerging molecular target for inflammatory diseases

OX40 (also known as CD134 and OX40 receptor) is a cell-surface receptor primarily expressed by activated T cells. It binds to OX40L expressed by antigen presenting cells and other immune cells mostly found in the tissue. OX40-OX40L signaling is important in T cell activation, expansion, and survival, playing an important role in the pathogenesis of various immunological, autoimmune, and inflammatory diseases.

~~IK-595~~Table is a dual MEK-RAF inhibitor designed to trap MEK and RAF in an inactive complex. The RAS-RAF-MEK-ERK cascade (MAPK pathway) regulates cell proliferation, differentiation, survival and therapeutic resistance. Activating mutations in this pathway are known to drive tumorigenesis in a large number of patient populations. Targeting MEK and RAF has the potential to benefit patients across a plethora of indications, including RAS and RAF-altered cancers, as monotherapy and when combined with other therapies. Contents

~~Existing~~During ~~drugs~~initial ~~targeting~~antigen ~~MEK~~recognition, ~~classified~~professional asantigen ~~kinase~~presenting ~~inhibitors,~~cells ~~are~~(“APCs”) ~~limited~~provide ~~by insufficient pathway inhibition and narrow therapeutic window. Therefore, these drugs are only currently addressing BRAF type I mutant cancer patients and NF1 mutant neurofibroma patients. One of~~ the ~~well-known~~OX40L ~~mechanisms~~signal ~~of resistance~~ to ~~existing~~activate ~~MEK~~OX40-expressing ~~inhibitors~~T incells. ~~RAS~~The ~~mutant~~activated ~~populations is through a CRAF~~OX40-~~mediated~~expressing ~~bypass.~~T ~~Upon~~cells ~~MEK inhibition with approved inhibitors, CRAF kinase activity~~ can bemigrate ~~reactivated~~ through ~~ERK~~circulation ~~mediated negative feedback control. CRAF function independent of its kinase activity also mediates resistance~~ to ~~MEK~~peripheral ~~and~~tissues ~~RAF~~where ~~kinase~~they ~~inhibitors.~~interact ~~These~~with ~~two~~various ~~important~~OX40L-expressing ~~CRAF~~resident ~~roles~~cells induring ~~tumorigenesis~~the ~~and~~effector ~~therapeutic~~phase, ~~resistance~~such ~~are~~as ~~significant~~B ~~factors~~cells, inNK ~~why~~cells, ~~existing~~mast ~~MEK inhibitors~~cells, ~~including~~endothelial ~~the~~cells, ~~four United States Food~~ and ~~Drug~~smooth ~~Administration~~muscle ~~(“FDA”) approved therapies~~cells, ~~are~~which ~~insufficient~~results ~~for~~in ~~serving~~a ~~the~~complex ~~large~~inflammatory ~~patient~~milieu ~~populations~~through ~~with~~OX40-OX40L ~~RAS~~signaling or(Figure ~~RAF gene alterations~~1).

Figure 1: OX40 is a co-stimulatory receptor that amplifies tissue inflammation

The key function of OX40-OX40L signaling is to promote the expansion and prolong the survival of T cells (Figure 2). During the effector phase, activated T cells differentiate into various subtypes of T cells which include:

•

Th1, Th2, Th17 and Th22 cells which mediate Type 1, 2, and 3 inflammation;

•

Activated memory T cells, which are long-living and can provide faster and stronger immune responses upon re-exposure to antigens. Activated memory T cells are thought to be critical in driving disease chronicity; and

•

CD8+T cells which exhibit cytotoxic functions to eliminate infected or abnormal cells.

Figure 2: OX40-OX40L signaling dysregulates multiple subsets of T cells

Importantly, OX40-OX40L signaling attenuates regulatory T cells, which are protective T cells that help maintain immune tolerance and prevent autoimmunity. In addition to regulating the expansion of various T cell subtypes, OX40-OX40L signaling increases the production of proinflammatory cytokines, chemokines, alarmins, and other mediators,

~~Our~~Table ~~Solution,~~of ~~IK-595~~Contents

~~IK-595~~including isthose athought ~~clinical~~to ~~stage,~~sustain ~~potent,~~disease ~~oral,~~chronicity. ~~small~~Aberrant ~~molecule MEK~~OX40-~~RAF~~OX40L ~~molecular~~signaling ~~glue,~~can ~~which~~contribute isto ~~designed~~the todevelopment ~~more~~of ~~comprehensively~~autoimmune ~~inhibit~~diseases ~~MAPK~~by ~~signaling~~promoting ~~than~~excessive ~~existing~~T ~~treatments,~~cell ~~while~~activation ~~achieving~~and apersistent ~~broader~~tissue ~~therapeutic~~inflammation. ~~window~~Elevated ~~for~~OX40L ~~patients.~~and ~~Through~~OX40 ~~its~~expressions ~~ability~~have tobeen ~~stabilize~~observed ~~MEK-RAF~~in ~~interaction,~~affected ~~including~~tissues ~~CRAF,~~across ~~IK-595~~various ~~aims~~immunological, toautoimmune, ~~prevent~~and ~~both~~inflammatory ~~CRAF~~diseases, ~~bypass~~including ~~and~~AD, ~~kinase-independent~~AA, ~~CRAF~~asthma ~~activity.~~and others.

IKBlocking OX40-~~595~~OX40L issignaling ~~currently~~may ~~being~~restore ~~evaluated~~and inrebalance immune homeostasis via suppressing various effector (such as Th1, Th2, Th17, and Th22) and memory T-cells while restoring regulatory T cells (“Tregs”), potentially impeding escalation of inflammation and future disease flares. Inhibiting OX40-OX40L signaling suppresses multiple pathogenic pathways, allowing for the potential to treat a ~~Phase~~diverse Irange of clinical ~~trial~~phenotypes inof ~~RAS~~AD and ~~RAF~~other ~~mutant cancers~~indications. The ~~first~~currently ~~patient~~available ~~was~~biologic ~~treated~~treatments ~~with~~primarily ~~IK-595~~target inthe ~~December~~Th2 ~~2023~~pathway, ~~and~~but AD is a ~~total~~heterogenous disease also driven by multiple other pathways, including Th1, Th17 and Th22 pathways. Despite the approval of 51DUPIXENT® (dupilumab), which inhibits the Th2 pathway, approximately 35% of patients treated with ~~advanced~~dupilumab ~~tumors~~are ~~and~~reported ~~MAPK~~to ~~alterations~~be ~~have~~refractory ~~been~~or ~~enrolled~~discontinue treatment due to adverse reactions, such as conjunctivitis, dry eyes, and ~~treated~~dupilumab facial dermatitis.

WeIn addition, inhibiting OX40-OX40L signaling using antagonistic monoclonal antibodies (“mAbs”) targeting OX40 or OX40L have ~~generated~~shown, ain ~~robust~~early ~~preclinical~~phase ~~dataset~~clinical ~~supporting~~trials, ~~IK-595~~sustained asclinical aactivity ~~potentially~~in ~~durable~~some ~~therapeutic~~patients, ~~solution~~lasting for ~~multiple~~months ~~cancer~~even ~~types~~after ~~linked~~treatment cessation. Such results suggest a potential for disease modifying activity in addition to ~~the~~control ~~RAS~~of ~~pathway~~signs and symptoms with such agents. If successful, ~~expanding~~this ~~the~~OX40-directed treatment approach could have several potential ~~populations~~advantages ~~that~~over ~~could~~the ~~benefit~~currently ~~from~~available ~~existing~~biologic ~~MEK~~treatments, ~~inhibitors~~such as DUPIXENT® used to treat AD patients. ~~These~~For ~~studies~~example, ~~demonstrate~~an OX40 antagonist like IMG-007 could be well-suited to treat a diverse range of clinical phenotypes, and/or ~~include:~~be dosed less frequently at initiation of treatment and also in long-term maintenance treatment.

~~Potent~~About ~~inhibition~~Atopic ~~capabilities of IK-595 through multiple biochemical and cellular potency assays;~~Dermatitis

~~IK-595’s~~AD ~~ability~~is tothe ~~stabilize~~most ~~MEK~~common subtype of eczema that affects individuals of all ages, races and ~~RAF~~geographies, including ~~CRAF,~~10-20% ~~which~~of wechildren ~~believe~~and 3% of adults worldwide. The prevalence of AD in adults in the U.S. is ~~key~~estimated to ~~differentiation~~be approximately 7.3%, or approximately 19.3 million patients in 2025. Across the ~~class;~~UK and Europe, prevalence is estimated at approximately 4.4%, or approximately 25 million AD adult patients in 2025. Approximately 35% of all AD patients have moderate-to-severe disease, eligible for biologic treatment.

~~IK-595’s~~AD ~~inhibition~~usually begins in early childhood. The cardinal skin features of ~~MEK~~AD ~~kinase~~are ~~activity;~~intense itch and localized or disseminated erythema (skin redness) and induration/papulation (raised rash) that may be accompanied by excoriations (scratch marks), erosions (skin wound), or skin oozing. An itch scratch cycle is established which leads to aggravated and chronic lesions with lichenification (skin thickening with exaggerated skin lines) and dry scales. At a given time, all types of skin lesions can coexist. Most AD patients have a comorbidity or prior history of atopic inflammatory conditions, such as asthma and food allergies. AD is also associated with a spectrum of non-inflammatory comorbidities, such as vitiligo, cardiovascular and psychiatric disorders.

~~Durable~~The ~~inhibition~~etiologies of ~~phosphorylated~~AD ~~ERK~~include epidermal barrier defects as well as dysregulation of the innate and ~~downstream~~adaptive immune systems, which result in a series of inflammatory responses involving complex cytokines and chemokines. Activated effector T cells are central to the acute and chronic inflammation in AD, including Th1, Th2, Th17 and Th22 cells and effector memory T cells. In addition, regulatory T cells are downregulated in AD lesions. These diverse subsets of T cells are all OX40 expressing cells, which would allow the OX40-OX40L antagonist class to target ~~gene~~a ~~expression;~~broader range of pathways implicated in pathophysiology of AD as compared to primarily Th2-targeting therapies currently approved for patients.

~~IK-595’s~~Current ~~preclinical~~atopic ~~anti-tumor~~dermatitis ~~efficacy~~treatment ~~in RAS~~ and ~~RAF~~development ~~altered cancer cell lines;~~landscape

~~Potential~~AD ~~synergy~~is ofcurrently ~~IK-595~~managed inthrough ~~combination~~symptom ~~with~~control ~~other~~and ~~targeted~~flare ~~therapies~~prevention. inTopical ~~vitro~~agents, ~~including~~such inas ~~combination~~corticosteroids ~~with~~and ~~KRAS~~calcineurin ~~G12C-~~inhibitors, ~~EGFR~~are ~~inhibitors~~the pharmacological agents mostly commonly utilized for the management of mild-to-moderate AD. Many AD patients, ~~PI3K~~especially ~~inhibitors~~those with moderate-to-severe AD, ~~chemotherapy~~fail ~~and~~to ~~others;~~show ~~and~~adequate clinical responses to topical agents or develop skin side effects that limit their further use.

IK-595 has been designed to have shorter half-life in humans to enable differentiated dosing strategies.

~~IK-595~~Table ~~Clinical~~of ~~Development Strategy~~Contents

WePhototherapy, ~~have~~such ~~explored~~as ~~multiple~~that ~~dosing~~with ~~schedules~~broadband inultra-violet ~~our ongoing Phase 1 clinical trial~~ (~~NCT06270082~~“UV”), ~~of IK~~narrow-~~595~~band inUVB, ~~patients~~or ~~with~~UVA1, ~~RAS~~is ~~and~~a ~~RAF~~treatment ~~mutant~~option ~~cancers~~in atadult ~~each~~or ~~dose~~adolescent ~~level~~patients. ~~The~~However, ~~first~~modest ~~patient~~efficacy, in the ~~Phase~~need 1for ~~clinical~~multiple ~~program~~office ~~was~~visits, ~~dosed in December 2023~~ and apotential ~~total~~long-term ofsafety 51concerns ~~patients~~associated with ~~advanced~~UV ~~tumors~~exposure ~~and~~limit ~~MAPK~~the ~~alterations~~overall ~~have~~use ~~been~~of ~~enrolled~~phototherapy and ~~treated~~its touse ~~date~~in younger patients.

~~Our~~Biologics ~~Additional~~can ~~Legacy~~be ~~Programs~~used in moderate-to-severe AD patients, including in both adults and children. The global AD biologics market was estimated to be approximately $15 billion in 2025 and is growing year-over-year (compound annual growth rate (CAGR) estimated 10-15%). However, only 15% of biologics-eligible patients in the US are estimated to be receiving treatment with such a therapy. Several mAbs have been approved by the FDA for the treatment of moderate-to-severe AD, including DUPIXENT® (dupilumab), ADBRY®(tralokinumab-ldrm), EBGLYSS™ (lebrikizumab-lbkz) and NEMLUVIO® (nemolizumab-ilto). Beyond biologic agents, oral JAK inhibitors are also approved which include CIBINQO® (abrocitinib), RINVOQ® (upadacitinib) and, OLUMIANT® (baricitinib, ex-US. JAK inhibitors, however, have significant safety concerns (carrying black box warnings) and require routine safety monitoring.

InGiven ~~December~~the ~~2024,~~relatively wehigh ~~entered~~prevalence ~~into~~of amoderate-to-severe ~~global~~AD ~~exclusive~~and ~~license~~unmet ~~agreement~~medical ~~with~~need ~~Foundery~~for ~~Immune~~additional ~~Studio,~~options ~~LLC,~~for ~~an immunotherapy focused venture firm~~patients, ~~which~~interest ~~encompasses~~in ~~three~~novel ~~assets:~~therapies ~~clinical-stage~~is ~~programs~~high ~~PY314, a TREM2 antagonist,~~ and ~~PY159,~~ a ~~TREM1~~range ~~antagonist;~~of ~~and~~therapies ~~Investigational New Drug Application (“IND”)-ready PY265, a MARCO antagonist. We~~ are ~~eligible~~currently toin ~~receive up to $1~~development.0 ~~billion~~Both increases in ~~regulatory~~the ~~and~~percentage ~~commercial~~of ~~milestones,~~patients ~~commercial~~treated ~~royalties,~~with ~~and have~~ a ~~right~~biologic toand ~~proceeds~~the ~~from~~anticipated ~~future~~approval ~~strategic~~of ~~transactions.~~new Weclasses ~~did~~of ~~not~~biologics ~~receive~~are anexpected ~~upfront~~to ~~payment~~contribute asto ~~part~~market growth of ~~this~~biologics ~~transaction~~in AD.

~~Our~~Rationale ~~IK-175~~for ~~aryl~~targeting ~~hydrocarbon receptor (“AHR”) antagonist program that was partnered with Bristol~~OX40-~~Myers~~OX40L ~~Squibb~~signaling Company (“Bristol-Myers Squibb”) completed its Phase 1 clinical trial in late 2023. Initial results shared in November 2022 demonstrate encouraging, durable, anti-tumor activity in stage 1 of both the monotherapy and combination arms in urothelial carcinoma patients. In January 2024, we announced that Bristol-Myers Squibb did not opt into the program. In March 2025 we entered into an asset sale agreement with a venture capital firm for the ~~sale~~treatment of ~~IK-175, pursuant to which we received a cash payment of $0.4 million.~~AD

InDysregulated ~~November~~T ~~2024~~cells, weincluding ~~entered~~Th1, ~~into~~Th2, anTh17, ~~asset~~Th22, ~~sale~~effector ~~agreement~~memory ~~with~~T ~~the~~cells, ~~same~~and ~~venture~~regulatory ~~capital~~T ~~firm~~cells, ~~for~~all ~~the~~of ~~sale~~which express OX40, are key drivers of ~~our~~AD ~~preclinical~~pathogenesis. ~~AHR~~The ~~agonist~~expression of OX40 by circulating activated skin-homing CD4+ T cells is increased in AD patients, ~~pursuant~~and toOX40+ ~~which~~and weOX40L+ ~~received~~cells aare ~~cash~~co-located ~~payment~~within the dermis, indicating local activity of ~~$1.5~~OX40-OX40L ~~million~~signaling.

InBlocking ~~March 2025, we entered into an agreement to assign intellectual property to the University of Texas (“UT”) for a solely~~OX40-~~owned~~OX40L ~~patent~~signaling ~~family~~is ~~related~~theorized to ~~IK-412,~~have ~~our~~two ~~preclinical~~possible ~~kynurenine~~advantages ~~targeting~~over ~~program.~~agents Weblocking ~~are~~the ~~eligible~~Th2 topathway ~~receive~~alone aby ~~portion~~having ~~of UT’s milestone payments or license fees generated from~~ the ~~assigned intellectual property, together with UT’s other intellectual property related to IK-412. We did not receive an upfront payment as part of this transaction.~~potential:

•

AsTo ~~previously~~address ~~disclosed~~more indiverse ~~May~~clinical ~~2024,~~phenotypes ~~after~~by anblocking ~~in-depth~~not ~~assessment~~only ~~of our programs~~Th2, webut ~~discontinued~~also ~~development~~Th1, ofTh17, ~~IK-930~~Th22, ~~our~~and ~~selective~~activated ~~Hippo~~memory ~~pathway~~T ~~inhibitor~~cells, ~~but~~and ~~may~~help ~~pursue~~restore ~~strategic~~regulatory ~~business~~T ~~development~~cells ~~opportunities~~(Table ~~for this program in the future, including out-licensing~~1).

•

~~Competition~~To be disease-modifying, durably reducing disease activity to a low level or even possibly inducing remission in some patients by influencing immune system memory. Such effects could allow for less frequent dosing or possibly treatment-free intervals for patients. This disease-modifying potential contrasts with approved targeted therapeutics for AD, which act upon AD disease signs and symptoms alone.

~~The~~Table ~~biotechnology~~1: ~~and~~Potential ~~pharmaceutical~~advantages ~~industries are characterized by rapid innovation~~ of ~~new~~blocking ~~technologies,~~OX40-OX40L ~~fierce~~signaling ~~competition,~~versus ~~and~~blocking ~~strong~~Th2 ~~defense~~signaling of intellectual property. While we believe that our pipeline and our knowledge, experience, and scientific resources provide us with competitive advantages, we face competition from major pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and public and private research institutions, among others. only

We compete in segments of pharmaceuticals and biotechnology, and there are other companies focusing on structural biology-guided chemistry-based drug design to develop therapies in the fields of cancer and other diseases. These companies include divisions of large pharmaceutical companies and biotechnology companies of various sizes. Any product candidates that we successfully develop and commercialize will compete with currently approved therapies and new therapies that may become available in the future from segments of the pharmaceutical, biotechnology and other related markets that pursue targeted oncology therapeutics. Key product features that would affect our ability to effectively compete with other therapeutics include the efficacy, safety, and convenience of our products.

Our competitors may obtain regulatory approval of their products more rapidly than we may or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our product candidates. Our competitors may also develop drugs that are more effective, more convenient, more widely used and less costly or have a better safety profile than our products and these competitors may also be more successful than us in manufacturing and marketing their products.

Furthermore, we also face competition more broadly across the market for cost-effective and reimbursable cancer treatments. The most common methods of treating patients with cancer are surgery, radiation and drug therapy, including chemotherapy, hormone therapy and targeted drug therapy or a combination of such methods. There are a variety of available drug therapies marketed for cancer. In many cases, these drugs are administered in combination to enhance efficacy. While our product candidates, if any are approved, may compete with these existing drug and other therapies, to the extent they are ultimately used in combination with or as an adjunct to these therapies, our product candidates may not be competitive with them. Some of these drugs are branded and subject to patent protection, and others are available on a generic basis. Insurers and other third-party payors may also encourage the use of generic products or specific branded products. We expect that if our product candidates are approved, they will be priced at a significant premium over competitive generic, including branded generic, products. As a result, obtaining market acceptance of, and gaining significant share of the market for, any of our product candidates that we successfully introduce to the market will pose challenges. In addition, many companies are developing new therapeutics, and we cannot predict what the standard of care will be as our product candidates progress through clinical development.

~~IK-595~~Table of Contents

InMonoclonal ~~addition~~antibodies toblocking ~~approved~~OX40-OX40L ~~MEK1/2~~signaling ~~inhibitors~~are ~~(Mekinist®,~~emerging ~~Mektovi®,~~biologics ~~Cotellic®,~~targeting ~~Koselugo®),~~broad ~~those~~pathways ~~pending~~for ~~review with~~ the ~~FDA,~~potential ~~including~~treatment ~~SpringWorks’ mirdametinib and Verastem’s MEK/RAF inhibitor, avutometinib (VS-6766), we are aware~~ of ~~the following IND~~moderate-~~ready and clinical~~to-~~stage~~severe MEK1/2 inhibitors: Nested Therapeutics, DayOne Biopharma’s pimasertib, KeChow Pharma’s tunlametinib (HL-085), Sino Biopharmaceutical’s TQB-3234, Fosun Pharma’s FCN-159, Recursion’s REC-4881, and Lupin’s LNP3794AD. ~~Additional~~Investigational ~~MEK/RAF~~anti-~~targeted~~OX40 ~~agents include Immuneering’s IMM-1-104~~(e.g., ~~and~~rocatinlimab) ~~IMM-6-415.~~or ~~Pan~~anti-~~RAF~~ ~~inhibitors~~OX40L ~~include DayOne Biopharma’s tovorafenib~~ (~~DAY-101)~~e.g., ~~Erasca’s naporafenibum (LXH-254~~amlitelimab), ~~BeiGene’s~~mAbs ~~lifirafenib~~have ~~(BGB-283),~~shown ~~Genentech’s~~durable ~~belvarafenib,~~clinical ~~Kinnate~~activity ~~Biopharma’s~~in ~~exarafenib~~some ~~(KIN-2787),~~patients ~~Jazz~~even ~~Pharma’s~~after ~~JZP-815,~~treatment ~~and Deciphera’s DCC-3084~~discontinuation.

~~License~~IMG-007 potently and ~~Collaboration~~specifically ~~Agreements~~blocks OX40-OX40L signaling

~~Master~~IMG-007 ~~Collaboration~~is ~~Agreement~~a ~~with~~novel, ~~Bristol~~non-~~Myers~~depleting ~~Squibb~~anti-OX40 IgG1mAb bioengineered to abolish ADCC (Figure 3). IMG-007 has been designed to specifically bind to OX40 receptor and block the interaction between OX40 and OX40L, thereby blocking OX40-OX40L signaling.

In ~~January~~designing ~~2019~~IMG-007, ~~we entered into~~ the ~~Bristol-Myers~~Fc ~~Squibb~~domain ~~Collaboration~~was ~~Agreement~~engineered ~~with~~to ~~Celgene~~silence ~~Corporation~~the ~~(which was acquired by Bristol~~antibody-~~Myers~~dependent ~~Squibb~~cellular incytotoxicity ~~November 2019~~(“ADCC”) ~~under~~function. ~~which~~ADCC ~~Bristol-Myers~~is ~~Squibb~~a ~~could~~cytotoxic ~~elect~~effector inmechanism ~~its~~by ~~sole~~which ~~discretion~~an toantibody ~~exclusively~~binds ~~license rights~~ to ~~develop~~ and ~~commercialize~~kills ~~compounds~~its ~~(and~~antigen ~~products~~expressing ~~and~~cells ~~diagnostic~~through ~~products~~engaging ~~containing~~its ~~such~~Fc ~~compounds)~~region ~~that~~with ~~modulate~~immune ~~the~~effector ~~activity of two collaboration targets~~cells, ~~kynurenine~~primarily ~~and~~natural ~~AHR,~~killer ~~excluding AHR agonists other than inverse agonists~~ (~~the~~ “~~Collaboration Candidates~~NK”), ~~known~~cells. asThe ~~IK-175~~silenced ~~and~~ADCC ~~IK-412.~~function ~~The~~in ~~Bristol~~IMG-~~Myers~~007 ~~Squibb~~enables ~~Collaboration~~binding ~~Agreement~~to ~~triggered~~OX40 anon ~~upfront~~activated ~~payment~~T ofcells ~~$95.0~~without ~~million,~~killing ~~which~~(depleting) ~~consisted~~these ofT ~~approximately $80~~cells.5 ~~million~~A innon-depleting ~~cash~~OX40 ~~and~~antibody anlike ~~equity~~IMG- ~~investment~~007 ofcould ~~approximately~~help ~~$14.5~~minimize ~~million~~potential ~~for~~safety ~~which~~and wetolerability ~~issued~~issues ~~14,545,450~~seen ~~shares~~with ofother ~~our~~agents ~~Series~~that ~~A-1~~are ~~Preferred~~believed ~~Stock~~to ~~pursuant~~result tofrom aADCC ~~separate~~and/or ~~stock~~T ~~purchase~~cell ~~agreement~~depletion. ~~The~~Examples ~~series~~of ~~A-1~~these ~~shares~~include ~~automatically~~symptoms ~~converted~~of ~~into~~pyrexia, ~~common~~chills, ~~stock~~or ~~upon~~aphthous ~~the~~or ~~completion~~gastrointestinal ~~of our initial public offering (“IPO”)~~ulcers.

OnFigure a3: ~~program-by-program~~Schematic ~~basis,~~structure ~~through the completion~~ of ~~a Phase 1b clinical trial for each of IK~~IMG-175 and IK-412, Bristol-Myers Squibb had the exclusive right with respect to such Collaboration Candidate to a worldwide exclusive license with us to develop, commercialize and manufacture the compound (and products and diagnostic products containing such compounds) underlying such Collaboration Candidate. The Collaboration Candidates were eligible for opt-in through early 2024. On January 17, 2024, Bristol-Myers Squibb notified us of its decision not to opt-in on the IK-175 program. In addition, Bristol-Myers Squibb did not provide an opt-in exercise for the IK-412 program. As a result, we regained full global rights to the IK-175 and IK-412 programs.007

~~Intellectual~~Data ~~Property~~supporting the differentiation of IMG-007 that we believe is a result of this engineering and its application in atopic dermatitis follows in this section. We have a robust collection of preclinical and clinical data. Our portfolio of preclinical studies of IMG-007 include:

•

WeThe ~~seek~~kinetics to protect the intellectual property and proprietary technology that we consider important to our business, including by pursuing patent applications that cover our product candidates and future products, and methods of ~~using the same, as well as any other relevant inventions and improvements that we believe to be commercially important to the development of our business. We also rely on trade secrets, know~~IMG-~~how~~007 ~~and~~binding ~~continuing technological innovation~~ to ~~develop~~human ~~and~~OX40 ~~maintain~~were ~~our~~evaluated ~~proprietary~~using ~~and~~surface ~~intellectual~~plasmon ~~property~~resonance ~~position.~~(“SPR”) ~~Our commercial success depends, in part,~~ on ~~our~~a ~~ability~~Biacore to8K ~~obtain~~(Cytiva), ~~maintain,~~demonstrating enforce and protect our intellectual property and other proprietary rights for the technology, inventions and improvements we consider important to our business, and to defend any patents we may own or inhigh-~~license~~affinity inbinding ~~the~~(KD future, prevent others from infringing any patents we may own or in-license in the future, preserve the confidentiality of our trade secrets, and operate without infringing, misappropriating or otherwise violating the valid and enforceable patents and proprietary rights of third parties~1.79 nM)

•

~~Patent~~IMG-007’s ~~Protection~~binding capacity to OX40 and other tumor necrosis factor receptor superfamily (“TNFRSF”) members were evaluated by an enzyme linked immunosorbent assay (“ELISA”); the results demonstrate high specificity of IMG-007 for OX40, with no measurable off-target binding to other TNFRSF members relative to the isotype control.

•

AsIMG-007’s ~~with~~effect ~~other~~on ~~biotechnology~~OX40-OX40L ~~and~~interactions ~~pharmaceutical~~was ~~companies,~~assessed ~~our~~by ~~ability~~ELISA. toThe ~~maintain~~inhibitory ~~and~~effect ~~solidify~~of ~~our~~IMG-007 ~~proprietary and intellectual property position for our product candidates, future products, and proprietary technologies will depend~~ on ~~our~~OX40L-induced ~~success~~NFkB activation in ~~obtaining~~HEK293-OX40-Luc ~~effective~~reporter ~~patent~~cells ~~claims~~was ~~and~~also ~~enforcing those claims if granted~~measured. ~~However,~~IMG-007 ~~our pending patent applications~~inhibited, ~~and any patent applications that we may~~ in ~~the~~a ~~future~~dose-dependent ~~file or license from third parties~~manner, ~~may~~OX40-OX40L ~~not~~protein-protein ~~result~~interactions in(Figure ~~the~~4) ~~issuance of patents~~ and ~~any~~OX40L-induced ~~issued~~NFkB ~~patents~~activation ~~we may obtain do not guarantee us the right to practice our technology or commercialize our product candidates. We also cannot predict the breadth of claims that may be allowed or enforced~~ in ~~any~~HEK293-OX40-Luc ~~patents~~cells ~~we may own or~~ in~~-license~~ invitro ~~the~~(Figure ~~future~~5). In ~~Any~~these ~~issued~~assays, ~~patents~~IMG-007 ~~that~~demonstrated wegreater ~~may~~potency ~~own or~~ in~~-license~~ ininhibiting ~~the~~OX40–OX40L ~~future~~interactions ~~may~~compared bewith ~~challenged,~~the ~~invalidated,~~reference ~~circumvented~~antibody, oran ~~have~~analogue ~~the scope~~ of ~~their claims narrowed~~telazorlimab. ~~In addition~~Notably, ~~because~~telazorlimab ofis ~~the extensive time required for clinical development and regulatory review of~~ a ~~product~~non–Fc-engineered ~~candidate~~IgG1 weanti-OX40 ~~may~~monoclonal ~~develop,~~antibody ~~it is possible~~ that, ~~before~~was ~~any~~previously ofevaluated ~~our product candidates can be commercialized, any related patent may expire or remain~~ in ~~force~~patients ~~for~~with ~~only~~moderate-to-severe ~~a short period following commercialization, thereby limiting the protection such patent would afford the respective product and any competitive advantage such patent may provide~~AD.

~~The~~Table ~~term~~ of individual patents depends 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. In most countries, including the United States, the patent term is 20 years from the earliest filing date of a non-provisional patent application. 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 expiring patent. The term of a patent claiming a new drug product may also be eligible for a limited patent term extension when FDA approval is granted, provided statutory and regulatory requirements are met. The term extension period granted on a patent covering a product is typically one-half the time between the effective date of a clinical investigation involving human beings is begun and the submission date of an application, plus the time between the submission date of an application and the ultimate approval date. The term extension period cannot be longer than five years, and the term extension period may not extend the patent term beyond 14 years from the date of FDA approval. Only one patent applicable to an approved product is eligible for the extension, and only those claims covering the approved product, a method for using it, or a method for manufacturing it may be extended. Additionally, the application for the extension must be submitted prior to the expiration of the patent in question. A patent that covers multiple products for which approval is sought can only be extended in connection with one of the approvals. The USPTO reviews and approves the application for any patent term extension in consultation with the FDA. In the future, if our product candidates receive approval by the FDA, we expect to apply for patent term extensions on any issued patents covering those products, depending upon the length of the clinical studies for each product and other factors. There can be no assurance that our pending patent applications, and any patent applications that we may in the future file or license from third parties, will issue or that we will benefit from any patent term extension or favorable adjustments to the terms of any patents we may own or in-license in the future. In addition, 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. Patent term may be inadequate to protect our competitive position on our products for an adequate amount of time.Contents

~~The~~Figure ~~patents~~4: ~~and~~IMG-007 ~~patent~~inhibited ~~applications~~OX40-OX40L ~~have~~protein-protein ~~claims relating to our current product candidates, methods of use and manufacturing processes, as well as claims directed to potential future products and developments.~~ interaction

~~MEK~~Figure ~~Inhibitor~~5: ~~Patent~~IMG-007 ~~Families~~inhibited OX40L-induced NFB activation in HEK293-OX40-Luc cells

AsThe ofacute ~~February~~xeno-GvHD ~~12,~~model ~~2025,~~in weNCG ~~solely~~mice ~~own~~is ~~three~~a ~~patent~~preclinical ~~families~~model ~~related~~which tois ~~MEK~~relevant ~~inhibitors~~to immune-modulated, ~~compositions~~T ~~thereof,~~cell ~~and~~driven ~~methods~~diseases. ofWe ~~their~~employed ~~use.~~this ~~Any~~model ~~U.S.~~to orevaluate ~~foreign~~the ~~patents~~in ~~that~~vivo ~~issue~~activity ~~from~~of ~~these~~IMG-007 ~~patent~~on ~~families,~~the ifdisease ~~granted~~activity and ~~all~~inhibitory ~~appropriate~~effect ~~maintenance~~on ~~fees~~human ~~paid,~~T ~~are~~cell ~~expected~~reconstitution toand ~~expire~~activation. ~~from~~In ~~2042~~this ~~to 2044~~study, ~~not~~IMG-007 ~~including~~demonstrated ~~any~~improvements ~~patent~~in ~~term~~animal ~~adjustment~~survival time (Figure 6A), ~~patent~~body ~~term~~weight ~~extension~~(Figure or6B), ~~supplementary~~and ~~protection~~clinical ~~certificate~~symptoms (~~“SPC”~~Figure 6C). ~~These~~by ~~patent~~suppressing ~~families~~T ~~are~~cell ~~described~~reconstitution in(Figure ~~more~~6D) ~~detail~~and ~~below~~activation (Figure 6E) in vivo.

We have one MEK patent family directed to a first collection of MEK inhibitors, compositions thereof, and methods of their use. As of February 12, 2025, this MEK patent family contains one pending U.S. application, and pending applications in foreign jurisdictions, such as Europe, Japan, China, Australia, Canada, India, and South Korea. Any U.S. or foreign patents that issue from this MEK patent family, if granted and all appropriate maintenance fees paid, are expected to expire in 2042, not including any patent term adjustment, patent term extension, or SPC.

We have one MEK patent family directed to a second collection of MEK inhibitors, compositions thereof, and methods of their use. As of February 12, 2025, this MEK patent family contains one issued U.S. patent, one pending U.S. non-provisional application, and pending applications in foreign jurisdictions, such as Europe, Japan, China, Australia, Canada, India, South Korea, Argentina and Taiwan. The issued U.S. patent includes composition of matter claims encompassing IK-595. Our issued U.S. patent and any U.S. or foreign patents that issue in the future from this MEK patent family, if granted and all appropriate maintenance fees paid, are expected to expire in 2043, not including any patent term adjustment, patent term extension, or SPC.

We have one MEK patent family directed to combinatorial methods of using MEK inhibitors. As of February 12, 2025, this MEK patent family contains one pending PCT application. Any U.S. or foreign patents that issue from this MEK patent family, if granted and all appropriate maintenance fees paid, are expected to expire in 2044, not including any patent term adjustment, patent term extension, or SPC.

Our current lead MEK inhibitor, IK-595, is covered by our solely owned U.S. patent with composition of matter claims, which is expected to expire in 2043, not including any patent term adjustment, patent term extension, or SPC. Our current lead MEK inhibitor, IK-595, compositions thereof, and methods of the use, are also covered by our solely owned pending U.S. and foreign patent applications, whereby any U.S. or foreign patents that, if granted and all appropriate maintenance fees paid, are expected to expire from 2043 to 2044, not including any patent term adjustment, patent term extension, or SPC.

~~Trade~~Table ~~Secret~~of ~~Protection~~ Contents

InFigure ~~addition to patents, we rely on unpatented trade secrets, know-how and continuing technological innovation to develop and maintain our competitive position~~6. ~~However, trade secrets and confidential know~~IMG-~~how~~007 ~~are~~exhibited ~~difficult~~protective toeffect protect. In particular, we anticipate that with respect to the building of our compound library, our trade secrets and know-how will over time be disseminated within the industry through independent development and public presentations describing the methodology. We seek to protect our proprietary information, in ~~part,~~an byacute ~~executing confidentiality agreements with our collaborators and scientific advisors and non~~xeno-~~competition,~~GvHD ~~non-solicitation,~~mouse confidentiality and invention assignment agreements with our employees and consultants. We have also executed agreements requiring assignment of inventions with selected consultants, scientific advisors and collaborators. The confidentiality agreements we enter into are designed to protect our proprietary information and the agreements or clauses requiring assignment of inventions to us are designed to grant us ownership of technologies that are developed through our relationship with the respective counterparty. We cannot guarantee that we will have executed such agreements with all applicable employees and contractors, or that these agreements will afford us adequate protection of our intellectual property and proprietary information rights. In addition, our trade secrets and/or confidential know-how may become known or be independently developed by a third party or misused by any collaborator to whom we disclose such information. These agreements may also be breached, and we may not have an adequate remedy for any such breach. Despite any measures taken to protect our intellectual property, unauthorized parties may attempt to copy aspects of our products or to obtain or use information that we regard as proprietary. Although we take steps to protect our proprietary information, third parties may independently develop the same or similar proprietary information or may otherwise gain access to our proprietary information. As a result, we may be unable to meaningfully protect our trade secrets and proprietary information. For more information regarding the risks related to our intellectual property, please see “Risk Factors—Risks Related to Our Intellectual Property.”model

~~Trademark~~A-C. ~~Protection~~Animal survival time (A), body weight (B) and clinical GvHD symptoms (C) in the modeled acute xeno- GvHD mice. D-E. Human CD45+ cells (mainly T cell) reconstitution (D) and human IFN level (E) in the blood of the modeled acute xeno-GvHD mice. N = 6 per group. Data are presented as mean ± SD in B and C, mean ± SEM in D and E.

WeTBI ~~have~~= ~~obtained~~total ~~registered~~body ~~trademarks~~irradiate, ~~with~~MST ~~the~~= ~~USPTO~~medium ~~for~~survival ~~the~~time, ~~IKENA~~** ~~and~~p ~~IKENA~~< ~~ONCOLOGY~~0.01 ~~word marks for services~~vs. WeTBI ~~have~~+ ~~pending~~hPBMC ~~applications~~+ ~~for~~Isotype ~~trademark~~group ~~protection~~analyzed ~~with~~by ~~the~~Log-rank ~~USPTO~~test ~~for~~in ~~the~~A ~~IKENA~~ and ~~IKENA~~unpaired ~~ONCOLOGY~~t ~~word~~test ~~marks~~in ~~for goods~~D.

~~Commercialization~~IMG-007 has been designed to silence the ADCC function to improve tolerability. We have conducted several studies to confirm that IMG-007’s ADCC function has been silenced as designed. IMG-007 exhibited minimal binding to Fcγ receptors in vitro and did not induce cytokine release in preclinical studies designed to assess potential agonistic effects.

~~Subject~~IMG-007’s toADCC ~~receiving~~effects ~~marketing~~were ~~approvals,~~evaluated weby ~~would~~measuring ~~expect~~the cytotoxicity to ~~commence~~HEK293T-Luc-OX40 ~~commercialization~~cells ~~activities~~ by ~~building~~fluorescence-activated acell ~~focused~~sorting. ~~sales~~A ~~and~~non-OX40 ~~marketing~~targeting ~~organization~~antibody inwith ~~the~~identical ~~United~~Fc ~~States~~portion to ~~sell~~IMG-007 ~~our~~was ~~products.~~included ~~The~~as ~~responsibilities~~an ofisotype ~~the~~(negative) ~~marketing~~control. ~~organization~~The ~~would~~study ~~include~~results ~~developing~~showed ~~educational~~that ~~initiatives~~IMG-007 ~~with~~did ~~respect~~not toinduce ~~approved~~any ~~products~~ADCC ~~and~~up ~~establishing~~to ~~relationships~~the ~~with~~highest ~~researchers~~concentration ~~and~~tested ~~practitioners~~(20 inμg/mL), ~~relevant~~whereas ~~fields of medicine. Outside~~ the ~~United~~GRB ~~States,~~830 we(a ~~expect~~wild totype ~~enter~~IgG1 ~~into~~which ~~distribution~~is ~~and~~ADCC ~~other~~competent) ~~marketing~~analogue ~~arrangements~~exhibited ~~with~~dose-related ~~third~~ADCC ~~parties~~effects ~~for~~(Figure ~~any of our product candidates that obtain marketing approval~~7).

~~Manufacturing~~Figure 7: IMG-007 did not exhibit T cell cytotoxicity in vitro

We do not have any manufacturing facilities. We currently rely, and expect to continue to rely, on third parties for the manufacture of our product candidates as well as for clinical testing and commercial manufacture if our product candidates receive marketing approval.

All of our drug candidates are small molecules and are manufactured in synthetic processes from available starting materials. The chemistry appears amenable to scale-up and does not currently require unusual equipment in the manufacturing process. If we continue to progress the development of our product candidates, we expect to rely on contract manufacturing facilities for our product candidate production needs.

If necessary, we expect to rely on third parties for the manufacture of companion diagnostics for our products, which are assays or tests to identify an appropriate patient population. Depending on the technology solutions we choose, we may rely on multiple third parties to manufacture and sell a single test.

Governmental 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, recordkeeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs. We, along with our vendors, contract research organizations (“CROs”), clinical investigators, and contract manufacturing organizations (“CMOs”) will be required to navigate the various preclinical, clinical, manufacturing and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek

~~approval~~Table of our product candidates. The process of obtaining regulatory approvals of drugs and ensuring subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources. Contents

InAn ~~the~~SPR ~~United~~assay ~~States,~~was ~~where~~performed weto ~~are~~test ~~initially focusing our drug development,~~ the ~~FDA~~binding ~~regulates~~affinities ~~drug~~of ~~products~~IMG-007 ~~under~~to the ~~Federal~~recombinant ~~Food,~~human ~~Drug,~~Fc ~~and~~gamma ~~Cosmetic~~receptors ~~Act, as amended~~ (“~~FD&C Act~~FcgRs”)~~, and its implementing regulations~~. ~~Drugs~~IMG-007 ~~are~~demonstrated ~~also~~minimal ~~subject~~binding to ~~other~~FcγRIIA, ~~federal~~FcγRIIIA, ~~state~~FcγRIIB/C, and ~~local~~FcγRIIIB, ~~statutes~~while ~~and~~binding ~~regulations. If we fail~~ to ~~comply~~FcγRI ~~with~~was ~~applicable~~approximately ~~FDA~~64-fold orlower ~~other~~than ~~requirements~~that atof ~~any~~the ~~time~~non–Fc-silenced ~~with~~version ~~respect~~of toIMG-007. ~~product development~~Importantly, ~~clinical~~the ~~testing,~~Fc ~~approval~~modification ordid ~~any~~not ~~other~~affect ~~regulatory~~FcRn ~~requirements relating to product manufacture~~binding, ~~processing,~~indicating ~~handling,~~preserved ~~storage,~~recycling ~~quality~~capacity ~~control,~~and ~~safety,~~that ~~marketing,~~the ~~advertising,~~N297A ~~promotion,~~engineering ~~packaging,~~achieved ~~labeling,~~the ~~export,~~intended ~~import,~~reduction ~~distribution,~~in orFcγ ~~sale,~~receptor weinteractions ~~may~~(Figure ~~become~~8). ~~subject~~Results toare ~~administrative~~shown oras ~~judicial~~sensorgrams ~~sanctions~~using orthe ~~other~~appropriate ~~legal~~kinetic ~~consequences.~~model; ~~These~~response ~~sanctions~~unit or(Y-axis) ~~consequences~~proportionally ~~could~~increases ~~include,~~with ~~among other things,~~ the ~~FDA’s~~concentrations ~~refusal~~(shown toin ~~approve~~colors) ~~pending~~indicates ~~applications,~~specific ~~issuance~~binding ofas ~~clinical~~shown ~~holds~~ for ongoing studies, suspension or withdrawal of approved applications, warning or untitled letters, product withdrawals or recalls, product seizures, relabeling or repackaging, total or partial suspensions of manufacturing or distribution, injunctions, fines, civil penalties or criminal prosecutionFcgRI.

~~Our~~Figure ~~product~~8: ~~candidates~~IMG-007 ~~must~~exhibited beminimal ~~approved~~binding ~~for~~to ~~therapeutic~~Fc indications by the FDA before they may be marketed in the United States. For drug product candidates regulated under the FD&C Act, FDA must approve a New Drug Application (“NDA”). The process generally involves the following: receptors

~~completion~~The effect of ~~extensive~~IMG-007 ~~preclinical~~on ~~studies~~inducing cytokine release was tested in ~~accordance~~an in vitro system by using human peripheral blood mononuclear cells (“PBMCs”) from ten healthy human donors. Recovered PBMC were treated with ~~applicable~~three ~~regulations~~concentrations (5 nM, ~~including~~100 ~~studies~~nM, ~~conducted~~and 2000 nM) of the test article for six and 48 hours under both solid phase format (coating antibody on plate) and a solution format (soluble antibody in ~~accordance~~buffer). Test articles included IMG-007, isotype (a non-OX40 targeting antibody with ~~good~~identical ~~laboratory~~Fc ~~practice~~portion to IMG 007) as a negative control, a GBR 830 analogue as a reference, and OKT3 (~~“GLP”~~an anti-CD3 targeting antibody which stimulates T-cells) ~~requirements;~~as a positive control. The culture supernatants were collected and measured for levels of ten proinflammatory cytokines including IFN-, IL-1ß, IL-2, IL-4, IL 6, IL-8, IL-10, IL-12p70, IL-13, and TNF-.

completion of the manufacture, under current Good Manufacturing Practices (“cGMP”) conditions, of the drug substance and drug product that the sponsor intends to use in human clinical trials along with required analytical and stability testing;

submission to the FDA of an IND which must become effective before clinical trials may begin and must be updated annually and when certain changes are made;

approval by an institutional review board (“IRB”) or independent ethics committee at each clinical trial site before each trial may be initiated;

performance of adequate and well-controlled clinical trials in accordance with applicable IND regulations, good clinical practice (“GCP”) requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication;

preparation and submission to the FDA of an NDA;

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

satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the drug will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the drug product’s identity, strength, quality and purity;

satisfactory completion of FDA audit of the clinical trial sites that generated the data in support of the NDA;

payment of user fees for FDA review of the NDA; and

FDA review and approval of the NDA, including, where applicable, consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug in the United States.

Preclinical Studies and Clinical Trials for Drugs

Before testing any drug in humans, the product candidate must undergo rigorous preclinical testing. Preclinical studies include laboratory evaluations of product chemistry, formulation and stability, as well as in vitro and animal studies to assess safety and in some cases to establish the rationale for therapeutic use. The conduct of preclinical studies is subject to federal and state regulation and requirements, including GLP requirements for safety/toxicology studies. The results of the preclinical studies, together with manufacturing information and analytical data, must be submitted to the FDA as part of an IND.

AnTable ~~IND is a request for authorization from the FDA to administer an investigational product to humans and must become effective before clinical trials may begin. The central focus~~ of an IND submission is on the general investigational plan and the protocol(s) for clinical studies. The IND also includes the results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; chemistry, manufacturing, and controls information; and any available human data or literature to support the use of the investigational product. Some long-term preclinical testing may continue after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the clinical trial, including concerns that human research subjects will be exposed to unreasonable health risks, and imposes a full or partial clinical hold. FDA must notify the sponsor of the grounds for the hold and any identified deficiencies must be resolved before the clinical trial can begin. Submission of an IND may result in the FDA not allowing clinical trials to commence or not allowing clinical trials to commence on the terms originally specified in the IND. A clinical hold can also be imposed once a trial has already begun, thereby halting the trial until the deficiencies articulated by FDA are corrected. Contents

~~The~~As ~~clinical~~shown ~~stage~~in ofFigure ~~development~~9A ~~involves~~(solid ~~the~~format) ~~administration~~and ofFigure ~~the~~9B ~~product~~(solution ~~candidate~~format), tocells ~~healthy~~treated ~~volunteers~~with ~~or patients under~~ the ~~supervision~~positive ofcontrol ~~qualified~~OKT3 ~~investigators,~~showed ~~who~~a ~~generally~~high ~~are~~level ~~physicians~~of ~~not~~cytokine ~~employed~~release byversus orlow ~~under~~level for the ~~trial~~isotype ~~sponsor’s~~negative control, ~~in accordance with GCP requirements,~~ which ~~include~~reflected the ~~requirements~~basal ~~that~~level ~~all~~of ~~research~~these ~~subjects~~cytokines ~~provide their informed consent for their participation~~ in ~~any~~the ~~clinical~~test ~~trial~~system. ~~Clinical~~IMG-007 ~~trials~~showed ~~are~~a ~~conducted~~comparable ~~under~~level ~~protocols detailing, among other things, the objectives~~ of ~~the~~cytokine ~~clinical~~release ~~trial,~~as ~~dosing procedures, subject selection and exclusion criteria and~~ the ~~parameters~~isotype ~~and~~negative ~~criteria to be used in monitoring safety and evaluating effectiveness~~control. ~~Each~~The ~~protocol,~~GBR ~~and~~830 ~~any~~analogue ~~subsequent~~exhibited ~~amendments~~some todegree ~~the~~of ~~protocol,~~dose ~~must~~dependent berelease ~~submitted to the FDA as part~~ of ~~the IND. Furthermore~~cytokine, ~~each clinical trial must be reviewed and approved by an IRB for each institution at~~ which ~~the~~may ~~clinical~~represent ~~trial~~a ~~will~~basal belevel ~~conducted~~of toADCC ~~ensure~~due ~~that the risks~~ to ~~individuals~~wild-type ~~participating~~IgG1 ~~in the clinical trials are minimized and are reasonable compared to the anticipated benefits~~antibody. The ~~IRB~~absence ~~also~~of ~~approves~~cytokine ~~the~~release ~~informed~~from ~~consent~~IMG-007 ~~form~~treatment ~~that~~may ~~must~~ be ~~provided~~due to ~~each clinical trial subject or his or her legal representative and must monitor~~ the ~~clinical~~Fc ~~trial~~modifications ~~until~~in ~~completed.~~IMG-007 ~~The~~intended ~~FDA, the IRB, or the sponsor may suspend or discontinue a clinical trial at any time on various grounds, including a finding that the subjects are being exposed~~ to anabolish ~~unacceptable~~Fc ~~health~~effector ~~risk~~function. There also are requirements governing the reporting of ongoing clinical trials and completed clinical trials to public registries. Information about clinical trials, including results for clinical trials other than Phase 1 investigations, must be submitted within specific timeframes for publication on www.ClinicalTrials.gov, a clinical trials database maintained by the National Institutes of Health.

AFigure ~~sponsor~~9: ~~who~~IMG-007 ~~wishes~~did ~~to conduct a clinical trial outside of the United States may, but need~~ not, ~~obtain~~induce ~~FDA~~cytokine ~~authorization~~release ~~to conduct the clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, FDA will nevertheless accept the results of the study~~ in ~~support of an NDA if the study was conducted in accordance with GCP requirements, and the FDA is able to validate the data through an onsite inspection if deemed necessary.~~ vitro

~~Clinical~~A: ~~trials~~Cytokine torelease ~~evaluate~~assay ~~therapeutic~~using ~~indications~~a tosolid ~~support~~phase ~~NDAs~~format ~~for~~from ~~marketing~~PBMCs ~~approval~~of ~~are~~ten ~~typically~~healthy ~~conducted~~human ~~in three sequential phases, which may overlap.~~ donors

~~Phase~~B: ~~1—Phase~~Cytokine 1release ~~clinical~~assay ~~trials~~using ~~involve~~a ~~initial~~solution ~~introduction~~format offrom ~~the~~PBMCs ~~investigational product in a limited population~~ of ten healthy human volunteers or patients with the target disease or condition. These studies are typically designed to test the safety, dosage tolerance, absorption, metabolism and distribution of the investigational product in humans, excretion the side effects associated with increasing doses, and, if possible, to gain early evidence of effectiveness. donors

~~Phase~~Results ~~2—Phase~~are 2shown ~~clinical~~as ~~trials~~heat ~~typically~~maps ~~involve~~where ~~administration of~~ the ~~investigational~~colors ~~product~~represent ~~to a limited patient population with a specified disease or condition to evaluate~~ the ~~drug’s~~percentile ~~potential~~value ~~efficacy,~~of tocytokine ~~determine~~levels: ~~the~~high ~~optimal~~level ~~dosages~~in ~~and~~red ~~dosing schedule~~ and tolower ~~identify~~level ~~possible~~in ~~adverse side effects and safety risks~~blue.

~~Phase~~Pharmacokinetics ~~3—Phase~~in 3 clinical trials typically involve administration of the investigational product 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 and physician labeling. Generally, two adequate and well-controlled Phase 3 trials are required by the FDA for approval of an NDA.humans

~~In March 2022, the FDA released final guidance titled “Expansion Cohorts: Use in First~~IMG-~~In-Human~~007 ~~Clinical~~has ~~Trials to Expedite Development of Oncology Drugs and Biologics,” which outlines how drug developers can utilize~~ an ~~adaptive~~extended ~~trial design commonly referred to as a seamless trial design in early stages of oncology drug development (i.e., the first~~half-~~in-human~~life ~~clinical trial) to compress the traditional three phases~~ of ~~trials~~approximately ~~into~~31 ~~one~~days ~~continuous trial called an expansion cohort trial. Information to support the design of individual expansion cohorts are included~~ in ~~IND~~IV ~~applications~~formulation and ~~assessed~~approximately ~~by FDA~~34.7 ~~Expansion~~days ~~cohort~~in ~~trials~~subcutaneous ~~can potentially bring efficiency to drug development and reduce development costs and time~~formulation.

In the Phase 1 single IV dose study of IMG-007 (Study 1), a total of 30 participants received a single IV dose of IMG-007, ranging from 1 to 600 mg. IMG-007 exhibited target-mediated drug disposition with non-linear PK at lower doses (£ 30 mg) and linear PK at higher doses (100 mg to 600 mg) (Figure 10). Clearance was higher at lower doses but approached a constant value of 0.107 to 0.166 L/day at higher doses. A single dose of IMG-007 at projected therapeutic dose levels of 300 to 600 mg maintained the projected target level (1.2 μg/ml) needed for blocking OX40-OX40L signaling in circulation for the entire follow-up period of 18 weeks. At projected therapeutic dose levels (300-600 mg), IMG-007 IV demonstrated a mean terminal half-life of 31 days.

~~Post-approval~~Table trials, sometimes referred to as Phase 4 clinical trials or post-marketing studies, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication and are commonly intended to generate additional safety data regarding use of the product in a clinical setting. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of NDA approval. Contents

~~Progress~~Figure ~~reports~~10: ~~detailing~~Serum ~~the~~concentration ~~results~~vs oftime ~~the~~profile clinical trials, among other information, must be submitted at least annually to the FDA. Written IND safety reports must be submitted to the FDA and the investigators fifteen (15) days after the trial sponsor determines the information qualifies for reporting for serious and unexpected suspected adverse events, findings from other studies or animal or in vitro testing that suggest a significant risk for human volunteers and any clinically important increase in the rate of aIMG-007 ~~serious~~following ~~suspected~~single ~~adverse~~IV ~~reaction~~Dose ~~over that listed in the protocol or investigator brochure. The sponsor must also notify the FDA of any unexpected fatal or life~~(Semi-~~threatening~~log ~~suspected adverse reaction as soon as possible but in no case later than seven calendar days after the sponsor’s initial receipt of the information.~~ Scale)

~~Concurrent~~Based ~~with~~on ~~clinical~~data ~~trials,~~from ~~companies~~a ~~usually~~Phase ~~complete~~1 ~~additional~~study ~~animal~~in ~~studies~~healthy ~~and~~adults. ~~must~~N=2 ~~also~~for ~~develop~~dose ~~additional~~groups ~~information~~1-10 ~~about~~mg, ~~the~~N=6 ~~chemistry and physical characteristics of the product candidate and finalize a process~~ for ~~manufacturing~~dose ~~the~~groups ~~drug~~30-600 ~~product in commercial quantities in accordance with cGMP requirements~~mg. The ~~manufacturing~~data ~~process~~show ~~must~~Mean be± ~~capable~~Standard ofDeviation. ~~consistently~~EC90: ~~producing~~The ~~quality~~90% ~~batches~~maximal ofeffective ~~the~~concentration ~~product candidate and manufacturers must develop, among other things, methods~~ for ~~testing~~ the ~~identity,~~inhibition ~~strength, quality and purity~~ of ~~the~~OX40-OX40L ~~final~~signaling ~~drug~~is ~~product~~~1.2 ~~Additionally,~~ug/mL ~~appropriate~~based ~~packaging~~on ~~must~~in-vitro ~~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~~assays.

UIn the Phase 1 single SC dose study of IMG-007 (Study 2), a total of 16 adult healthy participants were enrolled, of whom 12 received a single SC dose of IMG-007 (150 mg or 600 mg).S Serum concentrations were maintained above the projected target level (1.2 ~~Marketing~~μg/ml) ~~Approval~~needed for ~~Drugs~~blocking OX40-OX40L signaling in circulation for the entire follow-up period of 18 weeks (Figure 11). A single SC dose of 600 mg IMG-007 has demonstrated a mean terminal half-life of 34.7 days.

~~Assuming~~Figure ~~successful~~11: completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of an NDA package requesting approval to market the product for one or more indications. An NDA is a request for approval to market a new drug for one or more specified indications and must contain proof of the drug’s safety and efficacy for the requested indications. The marketing application is required to include both negative and ambiguous results of preclinical studies and clinical trials, as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls, and proposed labeling, among other things. Data may come from companyConcentration-~~sponsored~~time ~~clinical~~profile ~~trials intended to test the safety and efficacy~~ of a ~~product’s~~single ~~use~~SC ordose ~~from a number~~ of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the investigational drug to the satisfaction of the FDA. FDA must approve an NDA before a drug may be marketed in the United States. IMG-007

~~The~~Based FDA reviews all submitted NDAs to ensure they are sufficiently complete to permit substantive review before it accepts them for filing and may request additional information rather than accepting the NDA for filing. The FDA must make a decision on ~~accepting~~data anfrom ~~NDA for filing within 60 days of receipt, and such decision could include~~ a ~~refusal~~Phase to1 ~~file~~study byin ~~the~~healthy ~~FDA~~adults. ~~Once~~N=6 ~~the submission is accepted for filing, the FDA begins an~~ in~~-depth~~ ~~substantive~~each ~~review~~dose ~~of the NDA~~group. The ~~FDA~~data ~~reviews~~show anMean ~~NDA~~± toStandard ~~determine,~~Deviation ~~among~~1. ~~other~~EC90: ~~things,~~The ~~whether~~90% ~~the~~maximal ~~product is safe and~~ effective concentration for the ~~indications~~inhibition ~~sought~~of ~~and~~OX40-OX40L ~~whether~~signaling ~~the facility in which it~~ is ~~manufactured, processed, packaged or held meets standards designed, including cGMP requirements, designed to assure and preserve the product’s continued identity, strength, quality and purity~~~1.2 ~~Under~~ug/mL ~~the~~based ~~goals~~on ~~and polices agreed to by the FDA under the Prescription Drug User Fee Act (“PDUFA”), the FDA targets ten months, from the filing date,~~ in-vitro ~~which to complete its initial review of a new molecular entity NDA and respond to the applicant, and six months from the filing date of a new molecular entity NDA for priority review~~assays. ~~The FDA does not always meet its PDUFA goal dates for standard or priority NDAs and the review process is often extended by FDA requests for additional information or clarification.~~

Further, under PDUFA, as amended, each NDA must be accompanied by a substantial user fee. The FDA adjusts the PDUFA user fees on an annual basis. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business. Additionally, no user fees are assessed on NDAs for products designated as orphan drugs, unless the product also includes a non-orphan indication.

The FDA also may require submission of a Risk Evaluation and Mitigation Strategy (“REMS”) if it believes that a risk evaluation and mitigation strategy is necessary to ensure that the benefits of the drug outweigh its risks. A REMS can include use of risk evaluation and mitigation strategies like medication guides, physician communication plans, assessment plans, and/or elements to assure safe use, such as restricted distribution methods, patient registries, special monitoring or other risk-minimization tools.

~~The~~Table ~~FDA may refer an application for a novel drug to an advisory committee. An advisory committee is a panel~~ of independent experts, including clinicians and other scientific experts, which reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. Contents

~~Before~~IMG-007 ~~approving~~Clinical an NDA the FDA typically will 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 requirements and are adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA may inspect one or more clinical trial sites to assure compliance with GCP and other requirements and the integrity of the clinical data submitted to the FDA. development

~~After~~In ~~evaluating~~addition ~~the~~to ~~NDA~~our ~~and~~ongoing ~~all~~Phase ~~related~~2b ~~information,~~dose ~~including~~finding ~~the~~study advisory committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a Complete Response Letter. A Complete Response Letter indicates that the review cycle of ~~the~~IMG-007 ~~application is complete and the application is not ready for approval. A Complete Response Letter generally contains a statement of specific conditions that must be met~~ in ~~order~~patients towith ~~secure final approval of the NDA except that where the FDA determines that the data supporting the application are inadequate~~ moderate-to-severe ~~support approval~~AD, ~~the~~we ~~FDA~~have ~~may~~performed ~~issue~~four the Complete Response Letter without first conducting required inspections, testing submitted product lots, and/or reviewing proposed labeling. In issuing the Complete Response Letter, the FDA may require additional clinical ortrials ~~preclinical testing or recommend other actions, such as requests for additional information or clarification, that the applicant might take in order for the FDA to reconsider the application. Even~~ with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. IMG-007:

•

~~Even~~Study if1 ~~the~~was ~~FDA~~a ~~approves~~Phase a1 ~~product~~randomized, ~~depending~~double-blind, onplacebo-controlled, ~~the~~single ~~specific~~ascending ~~risk(s)~~dose study to beassess ~~addressed it may limit~~ the ~~approved~~safety ~~indications~~and ~~for~~pharmacokinetic ~~use~~(“PK”) profile of ~~the~~IMG-007 ~~product,~~IV ~~require~~in ~~that~~healthy ~~contraindications,~~participants. ~~warnings~~The orprimary ~~precautions~~objective bewas ~~included~~to inevaluate the ~~product~~safety ~~labeling,~~and ~~require~~tolerability ~~that~~of ~~post-approval~~single ~~studies,~~IV ~~including~~doses ~~Phase~~of 4IMG-007 ~~clinical~~in ~~trials,~~healthy beparticipants ~~conducted~~as tomeasured ~~further~~by ~~assess~~treatment aemergent ~~product’s~~adverse ~~safety~~events ~~after approval~~(“TEAEs”), ~~require~~safety ~~testing and surveillance programs to monitor the product after commercialization~~laboratory, orvital ~~impose other conditions~~sign, ~~including~~physical ~~distribution~~examination and ~~use~~electrocardiogram ~~restrictions~~(“ECG”) orparameters. ~~other~~The ~~risk~~key ~~management~~secondary ~~mechanisms~~objective ~~under~~was ato ~~REMS,~~characterize ~~which can materially affect~~ the ~~potential~~PK ~~market~~properties ~~and profitability~~ of ~~the~~a ~~product.~~single ~~The~~dose ~~FDA~~of ~~may~~IMG-007 ~~prevent~~in orhealthy ~~limit~~participants ~~further~~as ~~marketing~~measured ofby aserum ~~product~~concentration ~~based~~profile onand ~~the~~PK ~~results~~parameters. ofThis ~~post-marketing~~study ~~studies~~was orconducted ~~surveillance~~in ~~programs~~Australia. ~~After~~In ~~approval~~the study, ~~some~~30 ~~types~~participants ofreceived ~~changes~~a tosingle ~~the~~IV ~~approved product~~infusion, ~~such~~ranging asfrom ~~adding~~1 ~~new~~mg ~~indications,~~to ~~manufacturing~~600 ~~changes~~mg, and ~~additional~~14 ~~labeling~~participants ~~claims,~~received ~~are~~placebo. ~~subject~~Participants towere ~~further~~followed ~~testing~~up ~~requirements~~for ~~and~~up ~~FDA~~to ~~review~~18 ~~and approval~~weeks.

•

~~Orphan~~Study ~~Drug~~2 ~~Designation~~was a Phase 1 randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and ~~Exclusivity~~PK profile of IMG-007 SC in healthy participants. The primary objective was to evaluate the safety and tolerability of single SC doses of IMG-007 in healthy participants as measured by TEAEs, safety laboratory, vital sign, physical examination and ECG parameters. The key secondary objective was to characterize the PK properties of a single dose of IMG-007 in healthy participants as measured by serum concentration profile and PK parameters. This study was conducted in Australia. In the study, 16 participants received a single SC injection of 150 mg or 600 mg, and four participants received placebo. Participants were followed up for up to 18 weeks.

•

~~Under~~Study ~~the~~3 ~~Orphan~~was ~~Drug~~a ~~Act,~~Phase ~~the~~1b/2a ~~FDA~~study ~~may grant orphan drug designation~~ to aevaluate ~~drug~~the ~~intended~~safety, ~~to treat a rare disease or condition~~PK, ~~which~~efficacy isand aPD ~~disease~~effect orof ~~condition~~multiple ~~with~~IV ~~either~~doses ~~a patient population~~ of ~~fewer~~IMG-007 ~~than 200,000 individuals~~ in ~~the~~adult ~~United~~participants ~~States,~~with ormoderate-to-severe aAD. ~~patient~~The ~~population~~primary ~~greater~~objective ~~than~~was ~~200,000~~to ~~individuals~~evaluate in the ~~United~~safety ~~States~~and ~~when~~tolerability ~~there~~of ismultiple noIV ~~reasonable~~doses ~~expectation~~of ~~that~~IMG-007 ~~the~~in ~~cost~~adult ofparticipants ~~developing~~with ~~and~~moderate-to-severe ~~making~~AD ~~the~~as ~~product~~measured ~~available~~by inTEAEs, ~~the~~safety ~~United~~laboratory, ~~States~~vital ~~for~~sign, ~~the~~physical ~~disease~~examination orand ~~condition~~ECG ~~will~~parameters. beThe ~~recovered~~key ~~from~~secondary ~~sales~~objective ofwas ~~the~~to ~~product.~~assess ~~Orphan~~clinical ~~drug~~activity ~~designation~~as ~~must~~measured beby ~~requested~~EASI ~~before~~at ~~submitting~~Week ~~an NDA~~12. ~~After~~Further ~~the~~evaluations ~~FDA~~of ~~grants~~clinical ~~orphan~~activity ~~drug~~included ~~designation,~~improvements ~~the~~of ~~generic~~EASI, ~~identity~~objective Scoring of ~~the~~Atopic ~~therapeutic~~Dermatitis ~~agent~~(“O-SCORAD”) and ~~its~~Body ~~potential~~Surface ~~orphan~~Area ~~use~~(“BSA”) ~~are~~scores ~~disclosed publicly~~ by ~~the~~study ~~FDA.~~visit ~~Orphan~~up ~~drug~~to ~~designation~~Week ~~does~~24. ~~not~~A ~~convey~~total ~~any~~of ~~advantage~~13 inparticipants orwere ~~shorten~~enrolled ~~the~~from ~~duration~~six ofcenters in the ~~regulatory~~U.S. ~~review~~ and ~~approval~~Canada. ~~process,~~Participants ~~though~~received ~~companies~~up ~~developing~~to ~~orphan~~three ~~products~~IV ~~are~~infusions ~~eligible~~of ~~for~~300 ~~certain~~mg ~~incentives,~~over ~~including~~four ~~tax~~weeks ~~credits~~and ~~for~~were ~~qualified~~followed ~~clinical~~up ~~testing~~for ~~and~~up ~~waiver~~to of24 ~~application fees~~weeks.

•

IfStudy a4 ~~product~~was ~~that~~a ~~has~~Phase ~~orphan~~1b/2a ~~designation~~study ~~subsequently~~to ~~receives~~evaluate the ~~first~~safety, ~~FDA~~PK, ~~approval~~efficacy ~~for~~and ~~the~~PD ~~disease~~effect orof ~~condition~~multiple ~~for~~IV ~~which~~doses itof ~~has~~IMG-007 ~~such~~in ~~designation,~~adult ~~the~~participants ~~product~~with issevere ~~entitled~~AA. toThe aprimary ~~seven-year~~objective ~~period~~was ofto ~~marketing~~evaluate ~~exclusivity~~the ~~during~~safety ~~which~~and ~~the~~tolerability ~~FDA~~of ~~may~~multiple ~~not~~IV ~~approve~~doses ~~any~~of ~~other~~IMG-007 ~~applications~~in toadult ~~market~~participants ~~the~~with ~~same~~severe ~~therapeutic~~AA ~~agent~~as ~~for~~measured ~~the~~by ~~same indication~~TEAEs, ~~except~~safety inlaboratory, ~~limited~~vital ~~circumstances~~sign, ~~such~~physical asexamination aand ~~subsequent~~ECG ~~product’s~~parameters. ~~showing~~The ofkey ~~clinical~~secondary ~~superiority~~objective ~~over~~was ~~the~~to ~~product~~assess ~~with~~clinical ~~orphan~~activity ~~exclusivity~~as ormeasured ~~where~~by the ~~original~~Severity ~~applicant~~of ~~cannot~~Alopecia ~~produce~~Tool ~~sufficient~~(“SALT”) ~~quantities~~at ofWeek ~~product~~16. ~~Competitors,~~Further ~~however,~~evaluations ~~may receive approval~~ of ~~different~~clinical ~~therapeutic~~activity ~~agents~~included ~~for~~improvements ~~the~~of ~~indication~~SALT ~~for~~score ~~which~~by ~~the~~study ~~orphan~~visit ~~product~~up ~~has~~to ~~exclusivity~~Week or36. ~~obtain~~The ~~approval~~SALT ~~for~~score ~~the~~is ~~same therapeutic agent for~~ a ~~different~~validated ~~indication~~composite ~~than~~scoring ~~that~~system ~~for~~assessed ~~which~~by the ~~orphan~~investigator ~~product~~based ~~has~~on ~~exclusivity. Orphan product exclusivity could block~~ the ~~approval~~percentage of ~~one~~terminal ofhair ~~our~~loss ~~products~~in ~~for~~each ~~seven~~of ~~years~~the iffour ascalp ~~competitor~~areas ~~obtains~~(top, ~~approval~~back, ~~for~~right ~~the~~and ~~same~~left). ~~therapeutic~~The ~~agent~~SALT ~~for~~score ~~the~~ranges ~~same~~from ~~indication~~0 ~~before~~to ~~we do~~100, ~~unless~~with wehigher ~~are~~scores ~~able~~indicating tomore ~~demonstrate~~severe ~~that~~hair ~~our~~loss. ~~product~~A istotal ~~clinically~~of ~~superior.~~29 Ifparticipants anwere ~~orphan~~enrolled ~~designated~~from ~~product~~11 ~~receives~~centers ~~marketing~~in ~~approval~~the ~~for~~U.S. anand ~~indication~~Canada. ~~broader~~Among ~~than~~the ~~what~~29 ~~is designated~~enrolled, itsix ~~may~~participants ~~not~~received beup ~~entitled~~ to ~~orphan~~three ~~exclusivity.~~IV ~~Further,~~infusions ~~orphan~~of ~~drug~~300 ~~exclusive~~mg ~~marketing~~over ~~rights~~four inweeks ~~the~~(Cohort ~~United~~1) ~~States~~and ~~may~~23 bepatients ~~lost~~received ifup ~~the~~to ~~FDA~~three ~~later~~IV ~~determines~~infusions ~~that~~of ~~the~~600 ~~request~~mg ~~for~~over ~~designation~~four ~~was~~weeks ~~materially~~(Cohort ~~defective~~2). orParticipants ~~the~~were ~~manufacturer~~followed ofup ~~the approved product is unable~~ to ~~assure~~Week ~~sufficient~~24. ~~quantities~~Sixteen ofpatients ~~the~~in ~~product~~Cohort to2 ~~meet~~also ~~the~~participated ~~needs~~in ofan ~~patients~~optional ~~with~~extended ~~the~~follow-up ~~rare~~period ~~disease~~up orto ~~condition.~~Week 36.

Safety and tolerability

Including in the ongoing Phase 2b study in atopic dermatitis, over 150 subjects have participated in IMG-007 clinical trials. Based on the cumulative safety data so far, IMG-007 has been generally well-tolerated. There have been no reports of pyrexia or chills, or aphthous or gastrointestinal ulcers, and no evidence of hypersensitivity reactions, which may be due to the silenced ADCC function in IMG-007, in these early studies. Pyrexia and chills are common symptoms of cytokine releases due to cytotoxicity. Additionally, there have been no known cases or signs of malignancies, including Kaposi sarcoma, in any IMG-007 treated subjects or patients to date.

~~Expedited~~Table ~~Development~~of ~~and Review Programs for Drugs~~Contents

~~The~~A ~~FDA~~blinded ~~maintains~~safety ~~several~~review ~~programs~~of ~~intended~~the toongoing ~~facilitate~~ADAPTIVE ~~and~~trial ~~expedite~~was ~~development~~conducted ~~and~~in ~~review~~March 2026. A total of ~~new~~two ~~drugs~~serious adverse events, both deemed unrelated to ~~address~~IMG-007, ~~unmet~~were ~~medical~~reported. ~~needs~~Consistent inwith ~~the~~previous ~~treatment~~studies, no cases of ~~serious~~drug oradministration ~~life-threatening~~associated ~~diseases~~pyrexia, or ~~conditions.~~chills, ~~These~~aphthous ~~programs~~or ~~include~~gastrointestinal ~~fast~~ulcers, ~~track~~serious ~~designation,~~infections ~~breakthrough~~or ~~therapy~~malignancies ~~designation,~~have ~~priority~~been ~~review~~observed ~~and~~with ~~accelerated~~IMG-007 ~~approval~~treatment, ~~and~~including ~~the~~no ~~purpose~~cases of ~~these~~Kaposi’s ~~programs~~sarcoma. isMoreover, toacross ~~either~~all ~~expedite~~IMG-007 studies using the ~~development~~subcutaneous orformulation, ~~review~~as of ~~important~~March ~~new~~8, ~~drugs~~2026 tothe ~~get~~rate ~~them~~of toinjection ~~patients~~site ~~more~~reactions ~~quickly~~has been less than ~~standard~~0.10% ~~FDA~~with ~~review~~all ~~timelines~~reported ~~typically~~events ~~permit.~~being mild and transitory.

A ~~new~~review drug is eligible for fast track designation if it is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address unmet medical needs for such disease or condition. Fast track designation applies to the combination of the ~~product~~safety ~~candidate~~ and ~~the~~tolerability ~~specific~~results ~~indication for which it is being studied. Fast track designation provides increased opportunities for sponsor interactions with the FDA during preclinical and clinical development,~~ in ~~addition to~~ the ~~potential~~four ~~for~~previously ~~rolling~~completed ~~review~~IMG-007 ~~once~~studies ~~a marketing application~~ is ~~filed.~~described ~~Rolling review means that the FDA may review portions of the marketing application before the sponsor submits the complete application~~below.

In ~~addition~~the Phase 1 single IV dose study (Study 1), a ~~new~~total ~~drug~~of ~~may~~33 beof ~~eligible~~44 ~~for~~(77.3%) ~~breakthrough~~participants ~~therapy~~reported ~~designation~~at ifleast itone isTEAE, ~~intended~~including to73.3% ~~treat~~participants ain ~~serious~~the orcombined ~~life~~IMG-~~threatening~~007 ~~disease~~group orand ~~condition~~85.7% ~~and~~participants ~~preliminary~~in ~~clinical~~the ~~evidence~~placebo ~~indicates~~group. ~~that~~No ~~the~~SAEs ~~drug~~were ~~alone~~reported. All TEAEs were mild or inmoderate. ~~combination~~There ~~with~~were ~~one~~no orreports ~~more~~of ~~other~~pyrexia ~~drugs~~or ~~may~~chills. ~~demonstrate~~The ~~substantial~~TEAEs ~~improvement~~by ~~over~~preferred ~~existing~~term ~~therapies~~(“PT”) onoccurring ~~one~~in two or more ~~clinically~~participants ~~significant~~in ~~endpoints,~~the ~~such~~combined asIMG-007 ~~substantial~~group ~~treatment~~versus ~~effects~~the ~~observed~~placebo ~~early~~group are presented in ~~clinical~~Table ~~development~~2. ~~Breakthrough~~There ~~therapy~~were ~~designation~~no ~~provides~~TEAEs ~~all~~occurring more frequently in IMG-007 than the ~~features~~placebo ofgroup, ~~fast~~except ~~track~~for ~~designation~~isolated COVID-19 cases (16.7% in ~~addition~~the toIMG-007 ~~intensive~~versus ~~guidance~~0% onin anthe ~~efficient~~placebo ~~product~~group) ~~development~~with ~~program~~no ~~beginning~~dose-related astrend ~~early~~or asclinically ~~Phase~~significant 1,changes ~~and~~in ~~FDA~~levels ~~organizational~~of ~~commitment~~total toleukocytes ~~expedited~~or ~~development,~~lymphocytes ~~including~~among ~~involvement~~participants who contracted COVID-19. It was observed that 64.3% of ~~senior~~participants ~~managers~~in ~~and~~the ~~experienced~~placebo ~~review~~group ~~staff~~versus 46.7% of participants in the IMG-007 group had a ~~cross~~prior history of COVID-~~disciplinary~~19. ~~review~~Separately, ~~where~~there ~~appropriate~~were no increased incidences of other infection types observed in the IMG-007 groups compared to the placebo group. There were no clinically significant trends over time in the safety laboratory results, vital signs, physical examination, or ECG findings in the IMG-007 versus the placebo group.

~~Any~~Table ~~product~~2: ~~submitted~~TEAEs tooccurring the FDA for approval, including a product with fast track or breakthrough therapy designation, may also be eligible for additional FDA programs intended to expedite the review and approval process, including priority review designation and accelerated approval. A product is eligible for priority review, once an NDA is submitted, if the product that is the subject of the marketing application has the potential to provide a significant improvement in ~~safety~~two or ~~effectiveness~~more inparticipants ~~the~~(Study treatment, diagnosis or prevention of a serious disease or condition. Under priority review, the FDA’s goal date to take action on the marketing application is six months compared to ten months for a standard review. 1)

Products are eligible for accelerated approval if they are designed to treat a serious or life-threatening disease or condition and can be shown to have an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or an effect on a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality, which 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.


	Placebo	All IMG-007	Total
	(N=14)	(N=30)	(N=44)
Preferred Term (PT)	n (%)	n (%)	n (%)
Dermatitis contact	3 (21.4)	6 (20.0)	9 (20.5)
COVID-19	0 (0.0)	5 (16.7)	5 (11.4)
Headache	4 (28.6)	3 (10.0)	7 (15.9)
Myalgia	1 (7.1)	2 (6.7)	3 (6.8)
Upper respiratory tract infection	1 (7.1)	2 (6.7)	3 (6.8)

~~Accelerated~~In ~~approval~~this ~~is usually contingent on a sponsor’s agreement to conduct~~study, incytokine ~~a diligent manner~~(TNF-, ~~adequate and well~~IL-~~controlled~~6, ~~additional post~~IFN-~~approval confirmatory trials to verify and describe the product’s clinical benefit. Under the Food and Drug Omnibus Reform Act of 2022 (“FDORA”~~), ~~the~~test ~~FDA~~was iscollected ~~now~~at ~~permitted~~six ~~to require that such trials be underway prior to approval or within a specific time period after accelerated approval is granted. Additionally~~hours, ~~under~~Days ~~FDORA~~two, ~~the FDA has increased authority for expedited procedures to withdraw approval of a drug or an indication approved under accelerated approval if~~four, ~~for~~six ~~example,~~and ~~the~~eight ~~confirmatory~~post ~~trial fails to verify the predicted clinical benefit of the product~~doses. ~~In addition~~Overall, ~~for~~there ~~products~~were ~~being~~no ~~considered~~meaningful ~~for~~differences ~~accelerated~~in ~~approval,~~ the ~~FDA~~mean ~~generally~~cytokine ~~requires,~~levels ~~unless~~between ~~otherwise informed by~~ the ~~Agency, that all advertising and promotional materials intended for dissemination or publication within 120 days of marketing approval be submitted to the agency for review during the pre~~IMG-~~approval~~007 ~~review period. After the 120-day period has passed, all advertising~~ and ~~promotional~~placebo ~~materials must be submitted at least 30 days prior to the intended time of initial dissemination or publication~~group.

~~Even~~In ifthe Phase 1 single SC dose study (Study 2), 16 participants received a ~~product~~single ~~qualifies~~SC ~~for~~injection ~~one~~of IMG-007, 150 mg or ~~more~~600 ofmg, ~~these~~and ~~programs~~four participants received placebo. In total, 93.8% participants reported at least one TEAE, including 91.7% participants in the ~~FDA~~combined ~~may~~IMG-007 ~~later~~group ~~decide~~and ~~that~~100% of participants in the ~~product~~placebo group. There were no ~~longer~~SAEs. ~~meets~~All ~~the~~TEAEs ~~conditions~~were mild or moderate except for ~~qualification~~one orparticipant in the ~~time~~150 ~~period~~mg group who had a TEAE of Grade 3 (severe) “liver function test abnormal” according to common terminology criteria for ~~FDA~~adverse ~~review~~events orVersion ~~approval~~5.0, ~~may~~in ~~not~~the beabsence ~~shortened~~of a concurrent increase in total bilirubin or any clinical symptoms. ~~Furthermore~~Injection site reactions (“ISRs”), ~~fast~~including ~~track~~injection ~~designation~~site erythema, ~~breakthrough~~pain ~~therapy~~and ~~designation~~pruritus, ~~priority~~were ~~review~~the most commonly reported AEs and ~~accelerated~~occurred ~~approval~~more dofrequently ~~not~~in ~~change~~the placebo group (75%) than the ~~scientific~~IMG-007 orgroup ~~medical~~(25%). ~~standards~~All ~~for~~reported ~~approval~~ISRs were mild. Other than ISRs, TEAEs by PT that occurred in two or more participants in the ~~quality~~combined ofIMG-007 ~~evidence~~group ~~necessary~~versus tothe ~~support~~placebo ~~approval~~group are presented in Table 3. There were no TEAEs occurring more frequently in IMG-007 than the placebo group, ~~though~~except ~~they~~for ~~may~~TEAEs ~~expedite~~of acne and pruritus, which showed no dose related trend. No clinically significant trends over time in the ~~development~~safety laboratory results, vital signs, physical examination, or ~~review~~ECG ~~process~~findings in the IMG-007 versus the placebo group were observed.

~~Pediatric~~Table ~~Information~~of ~~and Pediatric Exclusivity~~ Contents

~~Under~~Table ~~the~~3: ~~Pediatric~~TEAEs ~~Research~~occurring ~~Equity Act (“PREA”), certain NDAs and certain NDA supplements must contain data that can be used to assess the safety and efficacy of the product candidate for the claimed indications~~ in ~~all~~two relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may grant deferrals for submission of pediatric data or ~~full~~more orparticipants partial waivers. The FD&C Act requires that a sponsor who is planning to submit a marketing application for a product candidate that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an initial Pediatric (Study ~~Plan (“PSP”) within 60 days of an end-of-Phase~~ 2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 study. The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct, including study objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver of the requirement to provide data from pediatric studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from preclinical studies, early phase clinical trials and/or other clinical development programs. Unless otherwise required by regulation, PREA does not apply to a drug for an indication for which orphan designation has been granted, except that PREA will apply to an original NDA for a new active ingredient that is orphan-designated if the drug is a molecularly targeted cancer product intended for the treatment of an adult cancer and is directed at a molecular target that FDA determines to be substantially relevant to the growth or progression of a pediatric cancer. )

A drug 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.


	Placebo	All IMG-007	Total
	(N=4)	(N=12)	(N=16)
Preferred Term (PT)	n (%)	n (%)	n (%)
Headache	3 (75.0)	4 (33.3)	7 (43.8)
Upper respiratory tract infection	1 (25.0)	3 (25.0)	4 (25.0)
Acne	0 (0.0)	3 (25.0)	3 (18.8)
Back pain	1 (25.0)	2 (16.7)	3 (18.8)
Pruritus	0 (0.0)	2 (16.7)	2 (12.5)
Respiratory tract infection	1 (25.0)	1 (8.3)	2 (12.5)

UIn the Phase 1b/2a multiple dose study (Study 3) in participants with AD who received up to three IV doses of IMG-007 300 mg over four weeks, nine of 13 (69.S2%) participants reported at least one TEAE. ~~Post-approval~~There ~~Requirements~~were no SAEs. All TEAEs were mild or moderate except for ~~Drugs~~one severe AE of AD flare (PT of dermatitis atopic) in a participant with erythrodermic AD. TEAEs by PT occurring in at least two participants were dermatitis atopic (four of 13 (30.8%) participants), urticaria (two of 13 (15.4%) participants), and hypertension (two of 13 (15.4%) participants). There were no clinically significant trends over time in the safety laboratory results, vital signs, physical examination, or ECG findings in the IMG-007 versus the placebo group.

~~Drugs~~The ~~manufactured~~Phase or1b/2a ~~distributed~~multiple ~~pursuant~~dose tostudy ~~FDA~~in ~~approvals~~AA ~~are~~(Study ~~subject~~4) toenrolled ~~continuing~~a ~~regulation~~total byof ~~the~~29 ~~FDA~~participants, ~~including,~~ among ~~other~~which ~~things,~~six ~~requirements~~participants ~~relating~~received up to ~~recordkeeping,~~three ~~periodic~~IV ~~reporting,~~infusions ~~product sampling and distribution, reporting~~ of ~~adverse~~IMG-007 ~~experiences~~300 ~~with~~mg ~~the~~over ~~product,~~four ~~complying~~weeks ~~with promotion~~ and ~~advertising~~23 ~~requirements,~~patients ~~which~~received ~~include~~up ~~restrictions~~to onthree ~~promoting~~IV ~~products~~infusions ~~for~~of ~~unapproved~~IMG-007 ~~uses~~600 ormg ~~patient~~over ~~populations~~four ~~(known~~weeks. ~~as “off~~Twenty-~~label~~two ~~use”)~~of ~~and~~29 ~~limitations~~enrolled onparticipants ~~industry-sponsored scientific and educational activities~~(75.9%) ~~Although~~reported ~~physicians~~at ~~may~~least ~~prescribe~~one ~~approved products for off-label uses~~TEAE, ~~manufacturers~~including ~~may~~three ~~not~~of ~~market~~six orparticipants ~~promote such uses~~(50.0%) ~~The~~in ~~FDA and other agencies actively enforce~~ the ~~laws and regulations prohibiting the promotion of off~~IMG-~~label~~007 ~~uses,~~300 ~~including~~mg ~~not~~group ~~only~~and by19 ~~company employees but also by agents~~ of ~~the~~23 ~~company~~participants or(82.6%) ~~those~~in ~~speaking on~~ the ~~company’s~~600 ~~behalf,~~mg ~~and~~group. aNo ~~company~~SAEs ~~that~~were isreported ~~found~~in toany ~~have~~treatment ~~improperly~~group. ~~promoted~~All ~~off-label~~TEAEs ~~uses~~were ~~may~~of bemild ~~subject~~or tomoderate ~~significant~~intensity. ~~liability,~~TEAEs ~~including investigation~~ by ~~federal~~PT ~~and~~occurring ~~state~~in ~~authorities.~~at ~~Failure~~least totwo ~~comply~~participants ~~with these requirements can result~~ in, ~~among~~any ~~other~~treatment ~~things,~~group ~~adverse~~were ~~publicity,~~headache ~~warning~~(four ~~letters~~(13.8%)), ~~corrective~~hypertension ~~advertising~~(two ~~and potential civil and criminal penalties~~(6.9%)), ~~including~~nasopharyngitis ~~liabilities~~(three ~~under the False Claims Act~~ (~~“FCA”~~10.3%)), ~~where~~and ~~products~~streptococcal ~~obtain~~infection ~~reimbursement~~(two ~~under federal health care programs~~(6.9%)). ~~Promotional~~There ~~materials~~were ~~for~~no ~~approved~~clinically ~~drugs~~significant ~~must~~trends beover ~~submitted~~time ~~to the FDA~~ in ~~conjunction~~safety ~~with~~laboratory ~~their first use or first publication. Further~~results, ifvital ~~there are any modifications to the drug~~signs, ~~including~~physical ~~changes in indications~~examinations, ~~labeling~~ or ~~manufacturing~~ECG processes or facilities, the applicant may be required to submit and obtain FDA approval of a new NDA supplement, which may require the development of additional data or preclinical studies and clinical trialsfindings.

~~The FDA may impose a number of post~~IMG-~~approval~~007 ~~requirements as a condition of approval of an NDA. For example, the FDA may require post-market testing, including Phase 4~~ clinical ~~trials,~~activity ~~and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization. In addition, manufacturers and their subcontractors involved~~ in ~~the~~atopic manufacture and distribution of approved drugs 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 ongoing regulatory requirements, including cGMPs, which impose certain procedural and documentation requirements on sponsors and their CMOs. Changes to the manufacturing process 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 upon us and any third party manufacturers that a sponsor may use. Manufacturers and manufacturers’ facilities are also required to comply with applicable product tracking and tracing 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. Failure to comply with statutory and regulatory requirements may subject a manufacturer to possible legal or regulatory action, such as warning letters, suspension of manufacturing, product seizures, injunctions, civil penalties or criminal prosecution. There is also a continuing, annual program user fee for any marketed product. dermatitis

IMG-007 showed early signs of durable clinical activity in adults with moderate-to-severe AD in our Phase 1b/2a POC study. The open-label Phase 1b/2a study (Study 3) evaluated the safety, PK and efficacy of multiple IV doses of IMG-007 in adults with moderate-to-severe AD. A total of 13 participants were enrolled from six centers in the U.S. and Canada. Baseline key disease characteristics included mean EASI score of 29.5, mean BSA of 52.0%, and 61.5% of patients had Investigator’s Global Assessments (“IGA”) score of 3 (moderate) and 38.5% had IGA score of 4 (severe).

Administration of three doses of IMG-007 at week zero, two, and four resulted in rapid disease symptom improvement which was maintained after the last dose at week four as measured by percent changes in the EASI score (Figure 12a), O-SCORAD (Figure 12b) and BSA scores (Figure 12c). At Week 20, mean percent change from baseline in EASI score was 87% and at Week 24 74%. The proportion of participants who achieved ³ 75% reduction from baseline in EASI (“EASI-75”) or ³ 90% reduction from baseline in EASI (“EASI-90”) is presented in Figure 13. 54% of patients achieved EASI-75 by Week 16 and maintained at Week 20.

~~The~~Table ~~FDA may withdraw approval~~ of a product 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, requirements for post-market studies or clinical trials to assess new safety risks, or imposition of distribution or other restrictions under a REMS. Other potential consequences include, among other things: Contents

~~restrictions~~Figure on12a: ~~the~~Percent ~~marketing~~(%) orchange ~~manufacturing~~from ofbaseline ~~the~~in ~~product,~~EASI ~~complete~~over ~~withdrawal~~time ofin ~~the~~IMG-007 ~~product~~Phase ~~from~~1b/2a ~~the~~study ~~market~~in oradults ~~product~~with ~~recalls;~~moderate-to-severe AD

~~the~~Figure ~~issuance~~12b: ofPercent ~~safety~~(%) ~~alerts,~~change ~~Dear~~from ~~Healthcare~~baseline ~~Provider~~in ~~letters,~~O-SCORAD ~~press~~over ~~releases~~time orin ~~other~~IMG-007 ~~communications~~Phase ~~containing~~1b/2a ~~warnings~~study orin ~~other~~adults ~~safety~~with ~~information~~moderate-to-severe ~~about the product;~~ AD

fines, warning letters or holds on post-approval clinical trials;

refusal of the FDA to approve applications or supplements to approved applications, or suspension or withdrawal of product approvals;

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

injunctions or the imposition of civil or criminal penalties; and

consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs; or mandated modification of promotional materials and labeling and issuance of corrective information.

Regulation of Companion Diagnostics

Companion diagnostics identify patients who are most likely to benefit from a particular therapeutic product; identify patients likely to be at increased risk for serious side effects as a result of treatment with a particular therapeutic product; or monitor response to treatment with a particular therapeutic product for the purpose of adjusting treatment to achieve improved safety or effectiveness. Companion diagnostics are regulated as medical devices by the FDA. In the United States, the FD&C Act, and its implementing regulations, and other federal and state statutes and regulations govern, among other things, medical device design and development, preclinical and clinical testing, premarket clearance or approval, registration and listing, manufacturing, labeling, storage, advertising and promotion, sales and distribution, export and import, and post-market surveillance. Unless an exemption or FDA exercise of enforcement discretion applies, diagnostic tests generally require marketing clearance or approval from the FDA prior to commercialization. The two primary types of FDA marketing authorization applicable to a medical device are clearance of a premarket notification (“510(k)”) and approval of a premarket approval application (“PMA”).

To obtain 510(k) clearance for a medical device, or for certain modifications to devices that have received 510(k) clearance, a manufacturer must submit a premarket notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device or to a pre-amendment device that was in commercial distribution before May 28, 1976 (a “predicate device”) for which the FDA has not yet called for the submission of a PMA. In making a determination that the device is substantially equivalent to a predicate device, the FDA compares the proposed device to the predicate device and assesses whether the subject device is comparable to the predicate device with respect to intended use, technology, design and other features which could affect safety and effectiveness. If the FDA determines that the subject device is substantially equivalent to the predicate device, the subject device may be cleared for marketing. The 510(k) premarket notification pathway generally takes from three to twelve months from the date the application is completed, but can take significantly longer.

A PMA must be supported by valid scientific evidence, which typically requires extensive data, including technical, preclinical, clinical and manufacturing data, to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device. For diagnostic tests, a PMA typically includes data regarding analytical and clinical validation studies. As part of its review of the PMA, the FDA will conduct a pre-approval inspection of the manufacturing facility or facilities to ensure compliance with the quality system regulation (“QSR”), which requires manufacturers to follow design, testing, control, documentation and other quality assurance procedures. The FDA’s review of an initial PMA is required by statute to take between six to ten months, although the process typically takes longer, and may require several years to complete. If the FDA evaluations of both the PMA and the manufacturing facilities are favorable, the FDA will either issue an approval letter or an approvable letter, which usually contains a number of conditions that must be met in order to secure the final approval of the PMA. If the FDA’s evaluation of the PMA or manufacturing facilities is not favorable, the FDA will deny the approval of the PMA or issue a not approvable letter. A not approvable letter will outline the deficiencies in the application and, where practical, will identify what is necessary to make the PMA approvable. Once granted, PMA approval may be withdrawn by the FDA if compliance with post-approval requirements, conditions of approval or other regulatory standards is not maintained or problems are identified following initial marketing.

InTable August 2014, the FDA issued a final guidance document addressing the development and approval process for “In Vitro Companion Diagnostic Devices.” According to the guidance document, for novel therapeutic products that depend on the use of a diagnostic test and where the diagnostic device could be essential for the safe and effective use of the corresponding therapeutic product, the companion diagnostic device should be developed and approved or cleared contemporaneously with the therapeutic, although the FDA recognizes that there may be cases when contemporaneous development may not be possible. However, in cases where a drug cannot be used safely or effectively without the companion diagnostic, the FDA’s guidance indicates it will generally not approve the drug without the approval or clearance of the diagnostic device. The FDA also issued a draft guidance in July 2016 setting forth the principles for co-development of an in vitro companion diagnostic device with a therapeutic product. The draft guidance describes principles to guide the development and contemporaneous marketing authorization for the therapeutic product and its corresponding in vitro companion diagnostic. Contents

InFigure ~~January~~12c: ~~2024,~~Percent ~~the~~(%) ~~FDA~~change ~~announced~~from ~~its~~baseline ~~intention to initiate the reclassification process for most~~ in ~~vitro~~BSA ~~diagnostics,~~over ~~including~~time ~~companion diagnostics. Further, the FDA indicated that~~ in ~~addition to the reclassification process, the FDA will continue taking a risk~~IMG-~~based~~007 ~~approach~~Phase in1b/2a ~~the~~study ~~initial classification of individual~~ in ~~vitro~~adults ~~diagnostics~~with moderate-to determine whether a new test may be classified into Class II through the de novo classification process. In so doing, the FDA indicated that it may regulate most future companion diagnostics as Class II devices, which would likely entail less onerous development, approval, and post-~~market~~severe ~~regulatory requirements than what is required for Class III medical devices and diagnostics that are subject to the PMA pathway.~~AD

~~Once~~The ~~cleared~~above orcharts ~~approved,~~show Mean ± Standard Error. N=13. Mixed-effect model with repeated measures (MMRM) were utilized for the ~~companion~~analysis. ~~diagnostic~~EASI: ~~device~~Eczema ~~must~~Area ~~adhere~~and toSeverity ~~post-marketing~~Index; ~~requirements~~EASI ~~including~~is a composite scoring system used in clinical trials to measure the ~~requirements~~extent (area) and severity of ~~the~~atopic ~~FDA’s~~eczema ~~QSR,~~(dermatitis). ~~adverse~~SCORAD: ~~event~~SCORing ~~reporting,~~Atopic ~~recalls~~Dermatitis; O-SCOARD: Objective SCOARD. SCORAD and ~~corrections~~O-SCORAD ~~along~~are ~~with~~composite ~~product~~scoring ~~marketing~~systems ~~requirements~~used in clinical trials to measure the extent and ~~limitations~~severity of AD. ~~Like~~BSA: ~~drug~~Body ~~makers,~~Surface ~~companion~~Area; ~~diagnostic~~BSA ~~makers~~is ~~are~~a ~~subject~~tool used in clinical trials to ~~unannounced~~measure ~~FDA~~the ~~inspections~~extent atof ~~any~~AD. ~~time~~Source: ~~during~~Company ~~which~~data ~~the~~on ~~FDA~~file. ~~will~~Shen ~~conduct~~Y anet ~~audit~~al. ofRevolutionizing ~~the~~Atopic ~~product~~Dermatitis (sRAD) ~~and~~annual conference 2024; Shen Y et al, the ~~company’s~~European ~~facilities~~Academy ~~for~~of ~~compliance~~Dermatology ~~with~~and ~~its~~Venereology ~~authorities~~(EADV) annual conference 2024.

~~Other~~Figure ~~Regulatory~~13: ~~Matters~~Proportion of participants who achieved EASI-75 or EASI-90 response in IMG-007 Phase 1b/2a study in adults with moderate-to-severe AD

~~Following~~N=13; ~~product~~Patients ~~approval,~~who ~~where~~received ~~applicable,~~rescue ~~the~~therapies ~~manufacturing,~~were ~~sales,~~counted ~~promotion~~as ~~and other activities around product candidates and/or commercialization are also subject to regulation by numerous regulatory authorities in the United States in addition to the FDA~~“non-responders.” ~~Regulatory~~Last ~~agencies~~observation ~~with~~carried ~~authority~~forward ~~over~~(LOCF) ~~product~~imputation ~~candidates~~was ~~may~~used ~~include,~~for ~~and~~missing ~~are not limited to~~data, ~~the~~except ~~Centers~~ for ~~Medicare~~missing &data ~~Medicaid~~that ~~Services~~arises ~~(“CMS”)~~following ~~other~~study ~~divisions~~discontinuation ofwith ~~the~~reason ~~U.S.~~‘lack ~~Department~~ of ~~Health~~efficacy’ ~~and Human Services~~ (~~“HHS”),~~none ~~the~~in ~~Department of Justice,~~ the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency and state and local governments and governmental agenciesstudy).

Other Healthcare Laws

Healthcare providers, physicians, and third-party payors, both governmental and commercial, will play a primary role in the recommendation and prescription of any products for which we obtain marketing approval. Our business operations and any current or future arrangements with third-party payors, healthcare providers and physicians may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we develop, market, sell and distribute any drugs for which we obtain marketing approval. In the United States, these laws include, without limitation, state and federal anti-kickback, false claims, physician transparency, price reporting, consumer protection and patient data privacy and security laws and regulations.

The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies continue to scrutinize interactions between healthcare companies and healthcare providers and increase investigations, prosecutions, convictions and significant settlements in the healthcare industry. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations 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 these laws or any other related governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, disgorgement, exclusion from government funded healthcare programs, such as Medicare and Medicaid, reputational harm, additional oversight and reporting obligations if we become subject to a corporate integrity agreement or similar settlement to resolve allegations of non-compliance with these laws and the curtailment or restructuring of our operations. If any of the physicians or other healthcare providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to similar actions, penalties and sanctions. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from its business.

~~Insurance~~Table ~~Coverage~~of ~~and Reimbursement~~ Contents

InIMG-007 ~~the~~has ~~U.S.~~also ~~and~~demonstrated ~~markets~~marked ~~in other countries, patients who are prescribed treatments for their conditions~~ and ~~providers~~durable ~~performing~~inhibition ~~the prescribed services generally rely on third-party payors to reimburse all or part~~ of ~~the~~inflammatory ~~associated~~biomarkers ~~healthcare costs. Thus, even if a product candidate is approved, sales of the product will depend,~~ in ~~part,~~adults onwith ~~the extent~~ moderate-to ~~which third~~-~~party~~severe ~~payors,~~AD ~~including government health programs~~ in ~~the~~a ~~U.S.~~Phase ~~such~~1b/2a ~~as Medicare and Medicaid, commercial health insurers and managed care organizations, provide coverage, and establish adequate reimbursement levels for, the product~~trial. In the ~~U.S.,~~IMG-007 ~~the~~Phase ~~principal~~1b/2a ~~decisions~~study, ~~about~~durable ~~reimbursement~~inhibitions ~~for~~of ~~new~~serum ~~medicines~~inflammatory ~~are~~markers ~~typically~~of ~~made~~diverse byTh ~~CMS~~cells, anincluding ~~agency~~Th1, ~~within~~Th2 ~~the HHS. CMS decides whether~~ and toTh17 what extent a new medicine will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. No uniform policy of coverage and reimbursement for drug products exists among third-party payors. Thereforecells, ~~coverage~~were ~~and~~observed ~~reimbursement~~ for ~~drug~~up ~~products can differ significantly from payor~~ to ~~payor.~~24 ~~The~~weeks ~~process~~(Figure for determining whether a third-party payor will provide coverage for a product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the product once coverage is approved14). ~~Factors payors consider in determining reimbursement are based on whether the product is, among other considerations:~~

aFigure ~~covered~~14: ~~benefit~~Th1, ~~under~~Th2, ~~its~~Th17 ~~health~~biomarkers ~~plan;~~were reduced to healthy ranges by IMG-007 treatment in Phase 1b/2a POC study

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~~cost-effective;~~n numbers at baseline, wk16, and 24 were 13, 6 and 6, respectively

~~neither~~Post-systemic ~~experimental~~rescue ~~nor~~treatment ~~investigational.~~results were censored from the analysis

InThe ~~order~~observed toclinical ~~secure~~activity ~~coverage~~ and ~~reimbursement~~biomarker ~~for~~data ~~any product~~ that ~~might~~resulted befrom ~~approved for sale,~~ a ~~company~~short ~~may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost~~4-~~effectiveness~~week ~~of the product~~treatment, ~~which~~as ~~will~~well ~~require~~as ~~additional expenditure above and beyond~~ the ~~costs~~generally ~~required~~well-tolerated ~~to obtain FDA or other comparable regulatory approvals. Additionally~~profile, ~~companies~~suggest ~~may~~that also need to provide discounts to purchasers, private health plans or government healthcare programs. Nonetheless, product candidates may not be considered medically necessary or cost effective. A decision by a third-party payor not to cover a product could reduce physician utilization once the ~~product~~ADCC issilencing ~~approved~~of ~~and have a material adverse effect on sales, our operations and financial condition. Additionally, a third~~IMG-~~party~~007 ~~payor’s~~has ~~decision~~retained to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage and reimbursement for the ~~product,~~desired ~~and~~biological ~~the~~activity ~~level~~ of ~~coverage~~OX40 ~~and~~blockade ~~reimbursement~~while ~~can~~improving ~~differ~~the ~~significantly from payor to payor~~tolerability.

~~The~~Ongoing containment of healthcare costs has become a priority of federal, state and foreign governments, and the prices of products have been a focus in this effort. Governments have shown significant interest in implementing costIMG-~~containment~~007 ~~programs,~~Phase ~~including~~2b ~~price~~AD controls, restrictions on 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 a company’s revenue generated from the sale of any approved products. Coverage policies and third-party payor reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which a company or its collaborators receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. study

~~Current~~We have initiated a Phase 2b dose-finding study (the ADAPTIVE trial) evaluating the efficacy and ~~Future~~safety ~~Healthcare~~of ~~Reform~~various ~~Legislation~~monotherapy dose regimens of IMG-007 SC formulation in adult participants with active moderate-to-severe AD who have had inadequate response to and/or who are intolerant of topical AD therapy, inclusive of patients who have received advanced systemic therapies, such as biologics and JAK inhibitors. A protocol amendment has been submitted to the FDA that expands the range of therapeutic exposures being evaluated in the context of this dose-finding study.

InThe ~~both~~study ~~the~~is ~~United~~intended ~~States~~to ~~and~~establish ~~certain~~Phase ~~foreign~~3 ~~jurisdictions,~~dosing ~~there~~with ~~have been~~ a ~~number~~primary objective of ~~legislative~~evaluating ~~and regulatory changes to~~ the ~~health~~effect ~~care~~of ~~system~~different ~~that~~dose ~~could~~regimens ~~impact~~of ~~our~~IMG-007, ~~ability~~compared to ~~sell our products profitably. In particular~~placebo, inon ~~2010,~~disease ~~the Patient Protection and Affordable Care Act~~activity, as ~~amended~~measured by ~~the~~percent ~~Health~~change ~~Care~~in ~~and~~EASI ~~Education~~from ~~Reconciliation~~baseline. ~~Act~~Secondary ofand ~~2010~~exploratory ~~was~~objectives ~~enacted,~~include ~~which,~~further ~~among~~evaluating ~~other things, subjected biologic products to potential competition by lower-cost biosimilars; addressed a new methodology by which rebates owed by manufacturers under~~ the ~~Medicaid~~safety ~~Drug~~profile ~~Rebate~~and ~~Program~~PK ~~are~~profiles ~~calculated~~of ~~for~~different ~~drugs~~regimens ~~that~~of ~~are inhaled~~IMG-007, ~~infused,~~as ~~instilled,~~well ~~implanted~~as orevaluating ~~injected; increased~~ the ~~minimum~~effect ~~Medicaid~~of ~~rebates~~different ~~owed~~dose byregimens ~~most manufacturers under the Medicaid Drug Rebate Program; extended the Medicaid Drug Rebate program to utilization~~ of ~~prescriptions~~IMG-007, ofcompared ~~individuals enrolled in Medicaid managed care organizations; subjected manufacturers~~ to ~~new annual fees and taxes for certain branded prescription drugs; created a new Medicare Part D coverage gap discount program~~placebo, inon ~~which~~disease ~~manufacturers must agree to offer 50% (later increased to 70%~~activity, ~~effective~~ as ofmeasured ~~January~~by 1EASI scores, ~~2019) point~~vIGA-~~of-sale~~AD ~~discounts~~scale ~~off~~in ~~negotiated~~AD ~~prices of applicable brand drugs to eligible beneficiaries during their coverage gap period~~participants, ~~as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;~~ and ~~provided~~other ~~incentives~~measures. toTopline ~~programs~~data ~~that~~from ~~increase~~ the ~~federal~~Phase ~~government’s~~2b ~~comparative~~clinical ~~effectiveness~~trial ~~research.~~is ~~Furthermore~~expected in August 2022, the Inflation Reduction Act was enacted, which among other things: allows for the Centers for Medicare & Medicaid Services to impose price controls for certain single-source drugs and biotherapeutics reimbursed under Medicare Part B and Part D2027.

IMG-007 potential expansion into additional indications

Since OX40-OX40L signaling is important in the pathogenesis of a spectrum of autoimmune and inflammatory diseases, IMG-007 has the potential to treat not only AD, but also other inflammatory diseases, such as AA, asthma, rheumatoid arthritis, hidradenitis suppurativa, and other immune and inflammatory indications.

Alopecia Areata

AA is an autoimmune disease characterized by hair loss involving the scalp, face, and/or body. Approximately 2% of the human population have the risk of the disease during their lifetime, most commonly starting before the age of 30.

~~Outside~~Table ~~the United States, ensuring coverage and adequate payment for a product also involves challenges. Pricing~~ of prescription pharmaceuticals is subject to government control in many countries. Pricing negotiations with government authorities can extend well beyond the receipt of regulatory approval for a product and may require a clinical trial that compares the cost-effectiveness of a product to other available therapies. The conduct of such a clinical trial could be expensive and result in delays in commercialization. Contents

InThe ~~the~~typical ~~European~~lesion ~~Union~~is ~~(“EU”), pricing and reimbursement schemes vary widely from country to country. Some countries provide that products may be marketed only after~~ a ~~reimbursement price has been agreed upon. Some countries may require the completion of additional studies that compare the cost~~non-~~effectiveness of a particular product candidate to currently available therapies or so-called health technology assessments~~scarring, ~~in order to obtain reimbursement or pricing approval. For example~~hairless, ~~the~~circular EUpatch provides options for its Member States to restrict the range of products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. EU Member States may approve a specific price for a product or may instead adopt a system of direct or indirect controls on the ~~profitability~~scalp, ofevolving ~~the company placing the product on the market. Other Member States allow companies~~ to ~~fix~~multiple ~~their own prices for products~~patches, but ~~monitor~~extensive ~~and~~forms ~~control~~can ~~prescription~~progress ~~volumes and issue guidance~~ to physicians to limit prescriptions. Recently, many countries in the EU have increased the amount of discounts required on pharmaceuticals and these efforts could continue as countries attempt to manage healthcare expenditures, especially in light of the severe fiscal and debt crises experienced by many countries in the EU. The downward pressure on healthcare costs in general, particularly prescription products, has become intense. As a ~~result,~~total ~~increasingly~~loss ~~high barriers are being erected to the entry~~ of ~~new~~scalp products. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various EU Member States, and parallel trade, i.e., arbitrage between low-priced and high-priced Member States, can further reduce prices. There can be no assurance that any country that has price controls or ~~reimbursement~~body ~~limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any products, if approved in those countries~~hair.

~~Compliance~~Table ~~with~~4: ~~Other~~On-label ~~Federal~~clinical ~~and~~safety ~~State~~of ~~Laws~~FDA orapproved ~~Requirements;~~JAK ~~Changing~~inhibitors ~~Legal~~for ~~Requirements~~the treatment of severe AA

If any products that we may develop are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act. Manufacturing, labeling, packaging, distribution, sales, promotion and other activities also are potentially subject to federal and state consumer protection and unfair competition laws, among other requirements to which we may be subject.


	OLUMIANT® (Baricitinib)1	LITFULO® (Ritlecitinib)2	LEQSELVI® (Deuroxolitinib)3
	OLUMIANT® (Baricitinib)1	LITFULO® (Ritlecitinib)2	LEQSELVI® (Deuroxolitinib)3

Adverse reactions reported in clinical trials (≥1%)	Upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infection, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase	Headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, blood creatine phosphokinase increased, herpes zoster, red blood cell count decreased, and stomatitis	Headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes.

Boxed Warning	Serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis	Serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis	Serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis.

~~The~~1. ~~distribution~~OLUMIANT ofPrescribing ~~pharmaceutical~~information. ~~products~~2. isLITFULO ~~subject~~Prescribing toinformation. ~~additional~~3. ~~requirements~~LEQSELVI ~~and~~Prescribing ~~regulations, including extensive recordkeeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products~~information.

~~The~~There ~~failure~~remains toa ~~comply~~significant ~~with~~unmet ~~any~~need offor ~~these~~safe ~~laws~~and oreffective ~~regulatory~~novel ~~requirements~~targeted ~~may~~systemic ~~subject~~therapies ~~firms~~for tolong-term ~~legal~~treatment orof ~~regulatory action~~AA. ~~Depending on the circumstances~~Currently, ~~failure~~there toare ~~meet~~no ~~applicable~~biologics ~~regulatory~~approved ~~requirements can result in criminal prosecution, fines or other penalties, injunctions, exclusion from federal healthcare programs, requests~~ for ~~recall,~~the ~~seizure~~treatment of ~~products,~~AA. ~~total~~IMG-007 oris ~~partial~~the ~~suspension~~first ofanti-OX40-OX40L ~~production,~~mAb ~~denial~~that orhas ~~withdrawal~~been ofevaluated ~~product~~in ~~approvals, relabeling or repackaging, or refusal to allow~~ a ~~firm~~clinical totrial ~~enter into supply contracts, including government contracts. Any claim or action against us~~ for ~~violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention from~~ the ~~operation~~treatment of ~~our business~~AA. ~~Prohibitions or restrictions on marketing, sales or withdrawal of future products marketed by us could materially affect our business in an adverse way.~~

~~Changes~~IMG-007 inclinical ~~regulations,~~activity ~~statutes or the interpretation of existing regulations could impact our business~~ in ~~the~~alopecia future by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to product labeling or packaging; (iii) the recall or discontinuation of our products; or (iv) additional recordkeeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. areata

~~Other~~Our Phase 1b/2a POC study in AA (Study 4) evaluated the safety, PK and efficacy of IV doses of IMG-007 in adults with severe AA. A total of 29 patients were enrolled from 11 centers in the U.S. ~~Environmental~~and Canada, ~~Health~~including ~~and~~6 ~~Safety~~patients ~~Laws~~in Cohort 1 who received up to three IV doses of 300 mg over four weeks (Baseline, Week 2 and ~~Regulations~~4) and 23 patients in Cohort 2 who received up to three IV doses of 600 mg over four weeks. Patients were followed up to Week 24. Sixteen patients in Cohort 2 also participated in an optional extended follow-up period up to Week 36.

WeKey ~~may~~disease becharacteristics ~~subject~~at tobaseline ~~numerous~~included ~~environmental,~~a ~~health~~mean ~~and~~duration ~~safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal~~ of ~~hazardous~~current ~~materials~~AA ~~and~~episode ~~wastes. From time to time and in the future, our operations may involve the use~~ of ~~hazardous and flammable materials, including chemicals and biological materials, and may also produce hazardous waste products~~3.0 ~~Even~~years ~~if we contract with third parties for the disposal of these materials~~ and ~~waste~~a ~~products,~~mean weSALT ~~cannot~~score ~~completely eliminate the risk~~ of ~~contamination or injury resulting from these materials~~80.4. InNine ~~the event~~ of ~~contamination~~29 or(31%) ~~injury~~enrolled ~~resulting~~patients ~~from~~had ~~the~~baseline ~~use~~SALT orscores ~~disposal~~ of ~~our~~95 ~~hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil~~ or ~~criminal fines and penalties for failure to comply with such laws and regulations~~greater.

A 4-week treatment with IMG-007 resulted in a dose-related clinical activity of hair regrowth. Patients in Cohort 1 did not show a meaningful reduction from baseline (a mean of 1.1%) in SALT score at Week 24.

Patients in Cohort 2 showed a mean reduction from baseline in SALT score of 14.3% at Week 24 and 21.7% at Week 36, continued to improve beyond Week 36 without plateau, approximately eight months after the last dose. At Week 36, 25% of patients in Cohort 2 achieved 30% or greater reduction from baseline in SALT score (“SALT30”). A preliminary clinical activity signal was observed in Cohort 2. Further, in Cohort 2, patients who had a baseline SALT score of 50 to less than 95 showed a 30% mean change in SALT score at week 36.

Figure 15: Improvement in SALT score after 4-week treatment with IMG-007 in Phase 1b/2a study in adults with severe AA

WeTable ~~maintain~~of workers’ compensation insurance to cover us for costs and expenses that we may incur due to injuries to our employees, but this insurance may not provide adequate coverage against potential liabilities. However, we do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us. Contents

InAll ~~addition,~~assessments weafter ~~may~~the ~~incur~~start ~~substantial~~date ~~costs~~of inprohibited ~~order~~medication towere ~~comply~~set ~~with~~to ~~current or future environmental, health and safety laws and regulations~~missing. ~~Current~~All orthe ~~future~~collected ~~environmental~~data ~~laws~~available ~~and~~after ~~regulations~~treatment ~~may~~discontinuation ~~impair~~were ~~our~~included ~~research, development or production efforts. In addition, failure to comply with these laws and regulations may result~~ in ~~substantial~~the ~~fines, penalties or other sanctions~~analysis.

~~Government~~Non-responder ~~Regulation~~imputation ofwas ~~Drugs~~performed ~~Outside~~for ofall scheduled visits following patient discontinuation from the ~~United~~study ~~States~~with the reason “lack of efficacy”.

ToLOCF ~~market~~approach ~~any~~was ~~product~~used ~~outside~~for ofall ~~the~~missing ~~United States~~visits, weexcept ~~would~~for ~~need~~missing todata ~~comply~~that ~~with~~arises ~~numerous~~following ~~and~~study ~~varying~~discontinuation ~~regulatory~~with ~~requirements~~reason of“lack ~~other countries regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization, manufacturing, commercial sales and distribution~~ of ~~our products~~efficacy”. ~~For instance, in the United Kingdom and the EU, medicinal products must be authorized for marketing by using either the centralized authorization procedure or national authorization procedures.~~

~~Centralized procedure—~~The ~~centralized~~number ~~procedure provides for the grant~~ of aparticipants ~~single marketing authorization by the European Commission that is valid throughout the EU, and~~ in the ~~additional~~600 ~~countries~~mg ofgroup ~~the~~was ~~European~~23 ~~Economic~~at ~~Area~~weeks ~~(Iceland,~~16 ~~Lichtenstein~~ and ~~Norway) (“EEA”). Pursuant to Regulation (EC) No. 726/2004~~24, the centralized procedure is compulsory for specific products, including for medicines produced by certain biotechnological processes, products designated as orphan medicinal products, advanced therapy medicinal products (gene therapy, somatic cell therapy and ~~tissue~~16 ~~engineered~~at ~~products)~~week ~~and products with a new active substance indicated for the treatment of certain diseases, which includes products for the treatment of cancer~~36. For medicines that do not fall within one of the mandatory categories, an applicant still has the option of submitting an application for a centralized marketing authorization to the European Medicines Agency (“EMA”) as long as the medicine concerned contains a new active substance not yet authorized in the EU, is a significant therapeutic, scientific or technical innovation, or if its authorization would be in the interest of public health in the EU. If pursuing a marketing authorization of a product candidate for a therapeutic indication under the centralized procedure, the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) is responsible for conducting an initial assessment of whether a product meets the required quality, safety and efficacy requirements, and whether a product has a positive benefit/risk ratio. Under the centralized procedure the maximum timeframe for the evaluation of a marketing authorization application (“MAA”) by the EMA is 210 days, excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP. Clock stops may extend the timeframe of evaluation of an MAA considerably beyond 210 days. Where the CHMP gives a positive opinion, it provides the opinion together with supporting documentation to the European Commission, who makes the final decision to grant a marketing authorization, which is issued within 67 days of receipt of the EMA’s recommendation. Accelerated assessment might be granted by the CHMP in exceptional cases, when a medicinal product is expected to be of major public health interest, particularly from the point of view of therapeutic innovation. The timeframe for the evaluation of an MAA under the accelerated assessment procedure is 150 days, excluding clock stops, but it is possible that the CHMP may revert to the standard time limit for the centralized procedure if it determines that the application is no longer appropriate to conduct an accelerated assessment.

~~National~~Figure ~~authorization~~16: ~~procedures—There~~Select ~~are~~patients ~~also~~in ~~two~~the ~~other~~600mg ~~possible~~dose ~~routes~~Cohort toshowed ~~authorize~~marked ~~products~~hair ~~for~~regrowth ~~therapeutic indications~~ in ~~several~~photographic ~~countries, which are available for products that fall outside the scope of the centralized procedure:~~ data

Decentralized procedure—Using the decentralized procedure, an applicant may apply for simultaneous authorizations in more than one EU Member State for a medicinal product that has not yet been authorized in any EU Member State and that does not fall within the mandatory scope of the centralized procedure.

Mutual recognition procedure—In the mutual recognition procedure, a medicine is first authorized in one EU Member State, in accordance with the national procedures of that country. Following this, additional marketing authorizations can be sought from other EU Member States in a procedure whereby the countries concerned recognize the validity of the original, national marketing authorization.

In both cases, as with the centralized procedure, the competent authorities of the EU Member States assess the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and efficacy before granting the marketing authorization.

InTable ~~the EU, new products for therapeutic indications that are authorized for marketing (i.e., innovator products) qualify for eight years~~ of data exclusivity and an additional two years of market exclusivity upon marketing authorization. The data exclusivity period prevents generic applicants from referencing the preclinical and clinical trial data contained in the dossier of the innovator product when applying for a generic marketing authorization in the EU during a period of eight years from the date on which the innovator product was first authorized in the EU. The additional two-year period of market exclusivity period prevents a successful generic applicant from commercializing its product in the EU until ten years have elapsed from the initial authorization of the reference product in the EU. The overall ten-year period can be extended to a maximum of eleven years if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with currently approved therapies. There is no guarantee that a product will be considered by the EMA to be a new chemical entity, and products may not qualify for data exclusivity. Even if a product is considered to be a new chemical entity so that the innovator gains the prescribed period of data exclusivity, another company could nevertheless also market another version of the product if such company obtained a marketing authorization based on an MAA with a complete and independent data package of pharmaceutical tests, preclinical tests and clinical trials. Contents

~~The~~In ~~criteria~~addition, ~~for~~IMG-007 ~~designating~~treatment anshowed ~~“orphan~~marked ~~medicinal~~and ~~product”~~durable ininhibition ~~the~~of EUinflammatory ~~are~~markers ~~similar~~ in ~~principle~~adults towith ~~those~~severe inAA ~~the United States. Under Article 3 of Regulation (EC) 141/2000,~~ in ~~the EU~~ a ~~medicinal~~Phase ~~product~~1b/2a ~~may~~trial. beIn ~~designated as an orphan medicinal product if it meets~~ the ~~following~~Phase ~~criteria:~~1b/2a ~~(1)~~AA ~~it is intended for the diagnosis~~study, ~~prevention~~scalp orbiopsy ~~treatment~~samples ofwere acollected ~~life-threatening~~at orBaseline ~~chronically~~and ~~debilitating~~Week ~~condition;~~16 (2) either (a) such condition affects no more than five in 10,000 persons in the EU when the application is made, or (b) it is unlikely that the product, without the benefits derived from orphan status, would generate sufficient return in the EU to justify the investment needed for ~~its development; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of such condition, or if such a method exists,~~ the ~~product~~evaluation ~~will be~~ of ainflammatory ~~significant benefit to those affected by that condition~~biomarkers. ~~Orphan~~At ~~medicinal~~baseline, ~~products~~patients ~~are~~showed ~~eligible~~activations ~~for financial incentives such as reduction~~ of ~~fees~~inflammatory ormarkers ~~fee waivers and are, upon grant~~ of ~~a marketing authorization~~Th1, ~~entitled to ten years of market exclusivity for the approved therapeutic indication. During this ten-year orphan market exclusivity period~~Th2, ~~no MAA shall be accepted,~~ and noCD8+ ~~marketing~~T ~~authorization~~cells ~~shall be granted for a similar medicinal product. A “similar medicinal product” is defined as a medicinal product containing a similar active substance or substances as contained~~ in anthe ~~authorized~~AA ~~orphan~~lesional ~~medicinal product~~scalp, ~~and~~compared ~~which~~to ~~is intended for~~ the ~~same~~non-lesional ~~therapeutic indication~~scalp. ~~The~~A ~~ten~~four-~~year~~week ~~market~~treatment ~~exclusivity~~with ~~may~~three bedoses ~~reduced to six years if, at the end~~ of ~~the~~600 ~~fifth~~mg ~~year,~~IMG-007 itresulted is established that the product no longer meets the criteria for orphan designation, for example, if the product is sufficiently profitable not to justify maintenance of market exclusivity. Market exclusivity may also be revoked in ~~very select cases, such as if (i) it is established that~~ a ~~similar~~marked ~~medicinal~~inhibition ~~product is safer, more effective or otherwise clinically superior than the authorized product; (ii) the marketing authorization holder~~ of ~~the~~inflammatory ~~authorized~~markers ~~product consents to such revocation; or (iii) the marketing authorization holder~~ of the authorized product cannot supply enough orphan medicinal product. An orphan medicinal product can also obtain an additional two years of market exclusivity in the EU for pediatric studies. The application for orphan designation must be submitted before the application for marketing authorization. The applicant will receive a fee reduction for the MAA if the orphan designation has been grantedTh1, ~~but~~Th2 ~~not~~and ifCD8+ ~~the~~T ~~designation~~cells ~~is still pending~~ at ~~the~~Week ~~time the marketing authorization is submitted. Orphan designation does not convey any advantage in~~16, orapproximately ~~shorten~~three ~~the~~months ~~duration~~after ~~of,~~ the ~~regulatory~~last ~~review~~dose ~~and~~(Figure ~~approval process~~17).

Prior to obtaining a marketing authorization in the EU, applicants must demonstrate compliance with all measures included in an EMA-approved pediatric investigation plan (“PIP”) covering all subsets of the pediatric population, unless the EMA has granted a product-specific waiver, a class waiver, or a deferral for one or more of the measures included in the PIP. The respective requirements for all marketing authorization procedures are laid down in Regulation (EC) No 1901/2006, the so-called Pediatric Regulation. This requirement also applies when a company wants to add a new indication, pharmaceutical form or route of administration for a medicine that is already authorized. The Pediatric Committee of the EMA (“PDCO”) may grant deferrals for some medicines, allowing a company to delay development of the medicine for children until there is enough information to demonstrate its effectiveness and safety in adults. The PDCO may also grant waivers when development of a medicine for children is not needed or is not appropriate, such as for diseases that only affect the elderly population. Before an MAA can be filed, or an existing marketing authorization can be amended, the EMA determines that companies actually comply with the agreed studies and measures listed in each relevant PIP. If an applicant obtains a marketing authorization in all EU Member States, or a marketing authorization granted in the centralized procedure by the European Commission, and the study results for the pediatric population are included in the product information, even when negative, the medicine is then eligible for an additional six-month period of qualifying patent protection through extension of the term of the SPC, provided an application for such extension is made at the same time as filing the SPC application for the product, or at any point up to 2 years before the SPC expires, even where the trial results are negative. In the case of orphan medicinal products, a two year extension of the orphan market exclusivity may be available. This pediatric reward is subject to specific conditions and is not automatically available when data in compliance with the PIP are developed and submitted.

In May 2017, the EU adopted the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”) which became applicable on 26 May 2022 and repealed Directive 98/79/EC on in vitro diagnostic medical devices. Devices that comply with the requirements of the IVDR are entitled to bear the CE conformity marking, indicating that the device conforms to the general safety and performance requirements of the IVDR, and, accordingly, can be commercially distributed throughout the EU (in-vitro diagnostic

~~medical~~Table ~~devices cannot be marketed in the EU without a CE Mark). The method~~ of assessing conformity varies depending on the class of the product, but normally involves a third-party assessment by a “Notified Body”. This third-party assessment may consist of an audit of the manufacturer’s quality system and specific testing of the manufacturer’s product.Contents

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In1. ~~April~~Kim ~~2014~~M, ~~the~~et ~~Clinical~~al. ~~Trials~~Allergy, ~~Regulation~~2024, 79(EU12): No3401-3414; ~~536/2014~~Guttman-Yassky ~~(Clinical~~E, ~~Trials~~et ~~Regulation) was adopted which replaced the Clinical Trials Directive 2001/20/EC~~al. ~~The Clinical Trials Regulation was entered into application on January 31~~JACI, 2022, ~~and is directly applicable in all the EU Member States~~ 149(~~meaning no national implementing legislation in each Member State is required~~4).: ~~The~~1318-1328; ~~transitory~~Fuentes‐Duculan ~~provisions of the Clinical Trials Regulation provide that~~J, byet ~~January 31, 2025, all ongoing clinical trials must have transitioned to the EU Clinical Trials Regulation~~al. ~~The~~Experimental Clinical Trials Regulation aims to simplify and streamline the approval of clinical trials in the EU. The main characteristics of the regulation include: a streamlined application procedure via a single-entry pointDermatology, ~~through the Clinical Trials Information System~~2016, 25(~~“CTIS”~~4);: a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors; and a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts (Part I contains scientific and medicinal product documentation and Part II contains the national and patient282-~~level documentation)~~286. Part I is assessed by a coordinated review by the competent authorities of all EU Member States in which an application for authorization of a clinical trial has been submitted (Member States concerned) of a draft report prepared by a Reference Member State. Part II is assessed separately by each Member State concerned. Strict deadlines have been established for the assessment of clinical trial applications. The role of the relevant ethics committees in the assessment procedure will continue to be governed by the national law of the concerned EU Member State. However, overall related timelines will be defined by the Clinical Trials Regulation.

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~~The~~For ~~European~~lesional ~~Commission~~scalp ~~introduced~~expression ~~legislative~~results ~~proposals in April 2023 that, if implemented, will replace the current regulatory framework in the EU for all medicines~~ (~~including those for rare diseases and for children~~600mg)., ~~The~~Ns ~~European~~at ~~Commission~~Baseline ~~has provided the legislative proposals to the European Parliament~~ and ~~the~~wk16 ~~European~~were ~~Council~~23 ~~for their review~~ and ~~approval~~17, ~~and,~~respectively. inNon-lesional ~~April~~scalp ~~2024,~~gene ~~the~~expression ~~European~~levels ~~Parliament~~were ~~proposed~~measured ~~amendments~~in to the ~~legislative~~corresponding ~~proposals.~~non-lesional ~~Once the European Commission’s legislative proposals are approved (with or without amendment)~~tissues, ~~they will be adopted into EU law~~n=14.

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Internationally, numerous jurisdictions have their own data security and privacy legal frameworks with which we will be required to comply if we conduct clinical trials in those jurisdictions or otherwise conduct business in those jurisdictions. We conduct clinical trials, and plan to conduct future clinical trials, in the EEA and the UK and therefore will collect personal data from data subjects in the EEA and the UK, and we will be subject to additional privacy restrictions. The collection, use, storage, disclosure, transfer or other processing of personal data in the EEA and UK is governed by the EU General Data Protection Regulation (the “EU GDPR”), with regards to the EEA, and the UK General Data Protection Regulation (“UK GDPR”), with regards to the UK, as well as applicable national data protection legislation and requirements in force within the EEA Member States and the UK (including the UK Data Protection Act 2018). In this Annual Report on Form 10-K, “GDPR” refers to both the EU GDPR and the UK GDPR, unless specified otherwise. The GDPR applies to the processing of personal data by any company established in the EEA/UK and to companies established outside the EEA/UK to the extent they process personal data in connection with the offering of goods or services to data subjects in the EEA/UK or the monitoring of the behavior of data subjects in the EEA/UK. The GDPR enhances data protection obligations for controllers of personal data, including stringent requirements relating to ensuring an appropriate legal basis or conditions applies to the processing of personal data, the consent (if required) of data subjects, expanded disclosures about how personal data is used, enhanced requirements for securing personal data, requirements to conduct data protection assessments for “high risk” processing, limitations on retention of personal data, mandatory data breach notification and “privacy by design” requirements, and creates direct obligations on service providers acting as processors. The GDPR also imposes strict rules on the transfer of personal data outside of the EEA to countries that do not ensure an adequate level of protection, like the United States in certain circumstances. Failure to comply with the requirements of the GDPR and the related national data protection laws of the EA Member States, (which may deviate slightly from the GDPR) and the UK, may result in fines of up to 4% of a company’s global revenue for the preceding financial year, or €20,000,000 (£17.5 million for the UK), whichever is greater. Moreover, the GDPR grants data subjects and non-profit associations the right to lodge complaints with supervisory authorities, seek judicial remedies, and claim material and non-material damages resulting from infringement of the GDPR. Given the strict nature of its data protection obligations, maintaining compliance with the GDPR will require significant time, resources and expense, and we may be required to put in place additional controls and processes ensuring compliance the GDPR. Competition

The biotechnology and biopharmaceutical industries are characterized by continuing technological advancement and significant competition. Any product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future. Many of the companies with which we are currently competing or will compete against in the future have significantly greater resources than we do. Mergers and acquisitions in the pharmaceutical and biotechnology industry may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific, clinical and management personnel, establishing clinical trial sites, patient enrollment for clinical trials as well as in acquiring technologies complementary to, or necessary for, our programs. Key competitive factors affecting the success of all our product candidates that we develop, if approved, are likely to be efficacy, safety, convenience, presentation, price, the level of generic competition and the availability of reimbursement from government and other third-party payors. Our competitors may also obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.

There are several approved products for moderate-to-severe AD, such as DUPIXENT® (dupilumab), an IL-4Ra mAb marketed by Sanofi/Regeneron, ADBRY® (tralokinumab-ldrm), an IL-13 mAb marketed by Leo Pharmaceuticals, and EBGLYSS™ (lebrikizumab-lbkz), an IL-13 mAb marketed by Eli Lilly and NEMLUVIO® (nemolizumab-ilto), an IL-31 mAb marketed by Galderma Laboratories, L.P. There are several approved treatments that target JAK1 and/or JAK2 to treat AD, including CIBINQO® (abrocitinib) marketed by Pfizer, RINVOQ® (upadacitinib) marketed by AbbVie and OLUMIANT® (baricitinib) marketed by Eli Lilly. These approved products have all demonstrated clinically significant efficacy results, but unmet need remains, with only an estimated 15% of moderate to severe patients receiving advanced therapy.

With the wide unmet need in AD and other inflammatory diseases, the development landscape is rich with mechanisms being explored as systemic therapies, including OX40, additional IL-13, IL-4Rα, IL-2, PEGylated IL-2, STAT6, ITK, TSLP, IRAK4, IL-31, and bispecific antibodies of these various targets. We believe competitors in development outside of the OX40-OX40L targeting field include, but are not limited to: rezpegaldesleukin (PEGylated IL-2 being developed by Nektar Therapeutics), zumilokibart (IL-13 antibody, APG777 being developed by Apogee Therapeutics), KT-621 (oral STAT6 inhibitor being developed by Kymera Therapeutics), bosakiutag (ATI-045, a TSLP mAb being developed by Aclaris Therapeutics), ATI-2138 (ITK/JAK3 inhibitor being developed by Aclaris

InTable ~~addition, many jurisdictions outside~~ of Europe are also considering and/or have enacted comprehensive data protection legislation. Compliance with these and any other applicable privacy and data security laws and regulations is a rigorous and time-intensive process, and we may be required to put in place additional mechanisms ensuring compliance with the new data protection rules. In addition, should we utilize third party distributors outside of the United States, compliance with such foreign governmental regulations would generally be the responsibility of such distributors, who may be independent contractors over whom we have limited control. If we fail to comply with any such laws or regulations, we may face significant fines and penalties that could adversely affect our business, financial condition and results of operations.Contents

~~Brexit~~Therapeutics), ~~and~~soquelitinib ~~the~~(ITK ~~Regulatory~~inhibitor ~~Framework~~being indeveloped by Corvus Pharma), the ~~United~~multi-specific ~~Kingdom~~antibody (IL-13 and IL-17) being developed by UCB Pharma, and others.

The UKmost ~~formally~~advanced ~~left~~OX40-O40L ~~the~~targeting EUagent on January 31, 2020, and, the EU and the UK have concluded a trade and cooperation agreement (“TCA”) which was provisionally applicable since January 1, 2021 and has been formally applicable since May 1, 2021. The TCA includes specific provisions concerning pharmaceuticals, which include the mutual recognition of GMP, inspections of manufacturing facilities for medicinal products and GMP documents issued, but does not provide for wholesale mutual recognition of UK and EU pharmaceutical regulations. At present, the UK has implemented EU legislation on the marketing, promotion and sale of medicinal products through the Human Medicines Regulations 2012 (as amended). The regulatory regime in ~~the~~development ~~UK therefore aligns in many ways with current EU regulations, however it~~ is ~~likely~~amlitelimab that these regimes will diverge significantly in the future now that the UK’s regulatory system is independent from the EU and the TCA does not provide for mutual recognition of UK and EU pharmaceutical legislation. However, notwithstanding that there is no wholesale recognition of EU pharmaceutical legislation under the TCA, under a new international recognition procedure which was put in place by the MHRA on January 1, 2024, the MHRA may take into account decisions on the approval of a marketing authorization from the EMA (~~and certain other regulators~~Sanofi), ~~when considering~~ an ~~application~~anti-OX40L ~~for a UK marketing authorization~~mAb.

AsIn aaddition, ~~result~~there ofare ~~the~~several ~~Northern~~other ~~Ireland~~OX40/OX40L ~~protocol,~~targeting ~~following~~agents ~~Brexit,~~in the ~~EMA~~pipelines ~~remained~~of ~~responsible~~various ~~for~~companies. ~~approving~~These ~~novel~~include ~~medicines~~monotherapies, ~~for~~free- ~~supply~~or infixed-dose ~~Northern~~combinations ~~Ireland~~of ~~under~~multiple ~~the EU centralized procedure~~antibodies, and avarious ~~separate~~bispecific ~~authorization~~constructs. ~~was~~Rocatinlimab, ~~required~~a toreceptor ~~supply~~targeting ~~the~~anti-OX40 ~~same~~mAb ~~medicine~~previously in ~~Great~~development ~~Britain~~by ~~(England,~~Amgen ~~Wales~~ and ~~Scotland).~~Kyowa ~~On February 27~~Kirin, ~~2023,~~is ~~the~~engineered UKin ~~government~~its ~~and~~Fc ~~the~~region ~~European~~for ~~Commission~~an ~~announced~~enhanced aADCC ~~political~~intended ~~agreement in principle~~ to ~~replace~~deplete ~~the~~OX40-expressing ~~Northern~~T ~~Ireland~~cells. ~~Protocol with a new set of arrangements~~Recently, ~~known~~Amgen asreturned the ~~“Windsor~~rights ~~Framework”.~~to ~~The~~the ~~Windsor~~program ~~Framework~~fully ~~was~~to ~~approved~~Kyowa byKirin ~~the~~and ~~EU-UK~~in ~~Joint Committee on~~ March ~~24,~~2026 ~~2023,~~Kyowa ~~and~~Kirin ~~the~~announced ~~medicines~~discontinuation ~~aspects~~ of ~~the~~rocatinlimab ~~Windsor~~development ~~Framework~~studies. ~~have~~Abcellera ~~applied~~is ~~since~~developing ~~January 1~~ABCL575, ~~2025.~~an ~~This~~OX40L ~~new~~targeting ~~framework~~mAb. ~~fundamentally~~Prior ~~changes~~to the ~~existing~~announcement ~~system~~of ~~under~~its ~~the~~acquisition ~~Northern~~by ~~Ireland Protocol~~BioCryst, ~~including~~Astria ~~with~~was ~~respect~~developing toSTAR-0310, ~~the~~a ~~regulation~~receptor oftargeting ~~medicinal products in the UK~~mAb. InAPG279 ~~particular, the MHRA~~ is ~~now~~a ~~responsible~~combination ~~for~~of ~~approving~~zumilokibart ~~all medicinal products destined for the UK market~~ (~~i.e.,~~IL13 ~~Great Britain and Northern Ireland~~targeting), and ~~the~~APG990 ~~EMA~~(anti-OX40L nomAb) ~~longer~~being ~~has~~developed ~~any~~Apogee ~~role~~Therapeutics. inNavigator ~~approving~~Medicines, ~~medicinal~~a ~~products~~private ~~destined~~company, ~~for~~is ~~Northern~~developing ~~Ireland~~NAV-240, ~~under~~an ~~the~~anti-OX40LxTNFα EUbispecific ~~centralized~~as ~~procedure.~~well Aas ~~single~~other UKanti-~~wide~~OX40L ~~marketing~~bispecific. ~~authorization~~In ~~will~~addition ~~be granted by the MHRA for all novel medicinal products~~ to ~~be sold in the UK~~amlitelimab, ~~enabling~~Sanofi ~~products~~has toseveral becombinations ~~sold~~and bispecifics in adevelopment ~~single~~with ~~pack~~OX40 and ~~under~~OX40L, aincluding ~~single authorization throughout the UK. In addition~~brivekimig, ~~the~~an ~~new~~anti-OX40LxTNFα ~~arrangements~~nanobody ~~require~~in ~~all~~development ~~medicines~~for ~~placed~~hidradenitis onsuppurativa, ~~the~~and ~~UK market to be labeled “UK only”~~SAR446422, ~~indicating~~an ~~they~~OX40/CD28 ~~are~~bispecific ~~not for sale in the EU~~antibody.

~~Human~~IP ~~Capital~~ Overview

AsOur offuture ~~February~~commercial ~~28,~~success ~~2025,~~depends wein ~~had~~part 10on ~~full-time~~our ~~employees,~~ability ofto ~~which~~obtain, ~~three~~maintain ~~have~~and ~~M.D.~~protect orintellectual ~~Ph.D.~~property ~~degrees.~~and ~~Within~~other ~~our~~proprietary ~~workforce,~~rights ~~three~~for ~~employees~~our ~~are~~current ~~engaged in research~~ and ~~development~~future ~~and~~product ~~seven~~candidates, ~~are~~to ~~engaged~~operate inwithout ~~business development~~infringing, ~~finance,~~misappropriating ~~legal,~~or ~~human~~otherwise ~~resources,~~violating ~~and~~the ~~general~~intellectual ~~management~~property and ~~administration.~~proprietary ~~None~~rights of ~~our~~others, ~~employees~~and ~~are~~to ~~represented~~prevent byothers ~~labor~~from ~~unions~~infringing, misappropriating or ~~covered~~otherwise byviolating ~~collective~~our ~~bargaining~~intellectual ~~agreements~~property and proprietary rights. We ~~consider~~seek ~~our~~to ~~relationship~~protect ~~with~~ our ~~employees~~proprietary toposition beby, ~~good.~~among ~~Our~~other ~~human~~methods, ~~capital~~filing ~~resources~~or ~~objectives~~exclusively ~~include,~~in-licensing aspatent ~~applicable,~~applications ~~identifying,~~related ~~recruiting,~~to ~~retaining~~our technology, ~~incentivizing~~inventions and ~~integrating~~improvements ~~our~~that ~~existing~~are ~~and~~important ~~additional~~to ~~employees.~~the ~~The~~development ~~principal~~and ~~purposes~~implementation of our ~~equity~~business. ~~incentive~~We ~~plans~~also ~~are~~rely toon ~~attract~~trade secrets, ~~retain~~know-how, ~~and~~continuing ~~motivate~~technological ~~selected~~innovation ~~employees,~~and ~~consultants~~potential ~~and~~future ~~directors~~in-licensing ~~through~~of ~~the~~intellectual ~~granting~~property ofto ~~stock-based~~develop ~~compensation~~and ~~awards.~~maintain our position.

~~Available~~As ~~Information~~for the therapeutic product candidate we are developing and seeking to commercialize, we have pursued composition-of-matter and therapeutic method of use patents, formulation patents, and therapeutic use patents on novel indications. Our therapeutic product candidate is a biologic, and more particularly a monoclonal antibody, so we intended to seek protection for amino acid and nucleotide sequences encoding the monoclonal antibody, and other claims conventionally used to protect aspects of therapeutic biological agents. We may also seek future patent protection, either alone or jointly with our collaborators, as our collaboration agreement may dictate.

Our ~~website~~patent ~~address~~portfolio isrelated ~~https://www.ikenaoncology.com/.~~to ~~Our~~IMG-007 ~~Annual~~as ~~Reports~~of onDecember ~~Form 10-K~~31, ~~Quarterly~~2025 ~~Reports~~includes onfour ~~Form~~patent ~~10-Q,~~families. ~~Current~~The ~~Reports~~first onpatent ~~Form 8-K~~family, ~~including~~exclusively ~~exhibits,~~licensed ~~proxy~~from ~~and~~Hutchmed ~~information~~under ~~statements~~the ~~and~~Hutchmed ~~amendments~~Agreement, tois ~~those~~directed ~~reports~~to ~~filed~~the orcomposition-of-matter ~~furnished~~of ~~pursuant~~the tomonoclonal ~~Sections~~antibody ~~13(a),~~IMG-007. ~~14,~~This ~~and~~patent ~~15(d)~~family ofincludes ~~the~~one ~~Exchange~~priority ~~Act~~patent application, ~~are~~together ~~available~~with ~~through~~one ~~the~~Taiwan ~~“Investors”~~patent ~~portion~~application, ofone ~~our~~Argentina ~~website~~patent ~~free~~application, ofand ~~charge~~one asinternational ~~soon~~patent asapplication ~~reasonably~~filed ~~practicable~~under ~~after~~the wePatent ~~electronically~~Cooperation ~~file~~Treaty ~~such material with~~(PCT), oreach ~~furnish~~claiming itpriority to, the ~~SEC.~~priority ~~Information~~patent onapplication ~~our~~under ~~website~~the isParis ~~not~~Convention ~~part~~for ofthe ~~this~~Protection ~~Annual~~of ~~Report~~Industrial onProperty ~~Form~~(Paris ~~10-K~~Convention). orFurthermore, ~~any~~the ofPCT ~~our~~application ~~other~~has ~~securities~~been ~~filings~~effectively ~~unless~~nationalized ~~specifically~~in ~~incorporated~~various byPCT ~~reference.~~member ~~In addition~~countries, ~~our~~including ~~filings~~national ~~with~~stage ~~the~~patent ~~SEC~~applications ~~may~~filed bein ~~accessed~~United ~~through~~States, ~~the~~Australia, ~~SEC’s~~Brazil, ~~Interactive~~Canada, ~~Data~~Chile, ~~Electronic~~China, ~~Applications~~Eurasia, ~~system~~Europe, atIndonesia, ~~www.sec.gov.~~Israel, ~~All~~India, ~~statements~~Japan, ~~made~~Korea, inMexico, ~~any~~Malaysia, ofNew ~~our~~Zealand, ~~securities~~Peru, ~~filings~~Philippines, ~~including~~Singapore, ~~all~~South ~~forward-looking~~Africa, ~~statements~~and orHong ~~information,~~Kong. ~~are~~The ~~made~~United asStates ofand ~~the~~Taiwan ~~date~~patents ofhave ~~the~~been ~~document~~granted in ~~which~~2024. ~~the~~We ~~statement~~would isexpect ~~included~~these patents to expire in 2041, ~~and~~without weconsidering doany ~~not~~possible ~~assume~~patent term adjustments or ~~undertake~~extensions. ~~any~~If ~~obligation~~the toremaining ~~update~~patent ~~any~~applications ofmature ~~those~~into ~~statements~~one or ~~documents~~more ~~unless~~issued patents, we ~~are~~expect ~~required~~those patents to doexpire soin by2041, ~~law~~without considering any possible patent term adjustments or extensions.

~~Our~~The ~~code~~second patent family is owned by us and is directed to intravenous formulations of ~~conduct,~~IMG-007. ~~corporate~~This ~~governance~~patent ~~guidelines~~family includes two priority patent applications together with one Taiwan patent application and one PCT application, both claiming priority to the ~~charters~~two ofpriority ~~our~~applications ~~audit~~under ~~committee~~the Paris Convention. Furthermore, ~~compensation~~The ~~committee~~PCT ~~and~~application ~~nominating~~has been effectively nationalized in various PCT member countries, including national stage patent applications filed in United States, Australia, Brazil, Canada, China, Israel, Japan, Mexico, Chile, Peru, Singapore, Malaysia, Philippines, New Zealand, Europe, India, Indonesia, Korea, South Africa, Eurasia, and ~~corporate~~Hong ~~governance~~Kong. ~~committee~~If ~~are~~these ~~available~~patent ~~through~~applications ~~the~~mature ~~“Corporate~~into ~~Governance”~~one ~~portion~~or ofmore ~~our~~issued ~~website~~patents, we would expect those patents to expire in 2042, without considering any possible patent term adjustments or extensions.

~~ITEM~~Table ~~1A.~~of ~~RISK FACTORS.~~Contents

~~Investing~~The inthird ~~our~~patent ~~common~~family ~~stock~~is ~~involves~~owned aby ~~high~~us ~~degree of risk. In evaluating the Company~~ and ~~our~~is ~~business,~~directed ~~careful~~to ~~consideration~~methods ~~should~~of beusing ~~given~~IMG-007. ~~the~~This ~~risks~~patent ~~described~~family ~~below,~~includes asone ~~well~~priority aspatent ~~the~~application ~~other~~together ~~information~~with inone ~~this~~PCT ~~Annual~~application ~~Report~~claiming onpriority ~~Form~~to ~~10-K~~the ~~and~~priority inpatent ~~other documents that we file with the SEC~~application. ~~The~~Furthermore, ~~occurrence of any of~~ the ~~events~~PCT orapplication ~~developments~~has ~~described~~been ~~below~~effectively ~~could~~nationalized ~~harm~~in ~~our~~various ~~business,~~PCT ~~financial~~member ~~condition~~countries, ~~results~~including ofnational ~~operations~~stage ~~and~~patent ~~growth~~applications ~~prospects.~~filed Inin ~~such~~United anStates, ~~event~~Australia, ~~the~~Canada, ~~market~~Europe, ~~price~~Japan, ofBrazil, ~~our~~Korea ~~common~~and ~~stock~~Israel. ~~could~~If ~~decline,~~these ~~and~~patent ~~our~~applications ~~stockholders~~mature ~~may~~into ~~lose~~one ~~all~~ or ~~part~~more ofissued ~~their~~patents, ~~investment.~~we ~~Additional~~would ~~risks~~expect ~~and~~those ~~uncertainties~~patents ~~not presently known~~ to usexpire orin ~~that~~2044, wewithout ~~currently~~considering ~~deem~~any ~~immaterial~~possible ~~also~~patent ~~may~~term ~~impair~~adjustments ~~our~~or ~~business operations~~extensions.

~~Risks~~The ~~Related~~fourth patent family is also owned by us and is directed to ~~Our~~subcutaneous ~~Strategic~~formulation ~~Alternatives~~of ~~Review~~IMG-007. ~~Process~~This patent family includes one priority patent application together with one Taiwan patent application and one PCT application, both claiming priority to the priority patent application under the Paris Convention. Furthermore, the international application can be effectively nationalized in multiple PCT member countries by filing national stage patent applications in those countries before September 2026. If these patent applications mature into one or more issued patents, we would expect these patents to expire in 2045, without considering any possible patent term adjustments or extensions.

~~Failure~~Provisional patent application is not eligible to ~~complete~~become an issued patent until, among other things, we file one or ~~delays~~more innational ~~completing~~patent applications and/or one or more PCT applications within 12 months of filing of such priority patent application. Moreover, a PCT application is not eligible to become an issued patent until, among other things, we file one or more national stage patent applications within, depending on the ~~proposed~~country, ~~Merger~~30 to 32 months of the PCT application’s priority date in the countries in which we seek patent protection. If we do not timely file any national patent applications or PCT applications, we may lose our priority date with ~~Inmagene~~respect ~~could~~to ~~materially~~our ~~and~~priority ~~adversely~~patent ~~affect~~applications. Furthermore, if we do not timely file any national patent applications in non-PCT countries within the, we may lose our ~~results~~opportunity ofand ~~operations~~right to patent subject matter disclosed in a priority application in those countries. Additionally, ~~business~~if we do not timely file any national stage patent applications, ~~financial~~we ~~results~~may lose our opportunity and~~/or~~ ~~stock~~right ~~price~~to patent subject matter disclosed in a PCT application in those countries. While we intend to timely file all of our patent applications, we cannot predict whether any such patent applications will result in the issuance of patents that provide us with any competitive advantage.

WeIndividual ~~undertook~~issued patents extend for varying periods depending on the date of filing of the patent application or the date of patent issuance and the legal term of patents in the countries in which they are obtained. Generally, utility patents issued for applications filed in the United States are granted a ~~comprehensive~~term ~~review~~of 20 years from the earliest effective filing date of ~~strategic~~a ~~alternatives~~non-provisional U.S. patent application or a PCT application designating the U.S.. The term of a patent, and the protection it affords, is therefore limited and once the patent term of our issued patents have expired, we may face competition, including ~~identifying~~other competing technologies. Because of the extensive time required for clinical development and ~~reviewing~~regulatory ~~potential~~review of a drug we may develop, it is possible that, before any of our product candidates can be commercialized, any related patent may expire or remain in force for only a ~~merger~~short period following commercialization, thereby reducing any advantage of any such patent.

OnIn ~~December 23~~addition, ~~2024,~~in wecertain ~~entered into the Merger Agreement with Insight Merger Sub I~~instances, ana ~~exempted~~U.S. ~~company~~patent ~~with~~term ~~limited~~can ~~liability~~be ~~incorporated~~extended ~~and~~to ~~existing~~recapture ~~under~~a ~~the~~portion ~~laws~~ of the ~~Cayman~~term ~~Islands~~effectively ~~and~~lost ~~our~~as ~~direct~~a ~~wholly~~result ~~owned subsidiary (“Merger Sub I”), Insight Merger Sub II, an exempted company with limited liability incorporated and existing under the laws~~ of ~~the~~FDA ~~Cayman~~regulatory ~~Islands~~review ~~and~~period our direct wholly owned subsidiary (“Merger Sub II” and, collectively with Merger Sub I, “Merger Subs”), and Inmagene, an exempted company with limited liability incorporated and existing under the laws of the Cayman Islands, pursuant to which, among other matters, and subject to the satisfaction or ~~waiver~~delay ofby the ~~conditions~~United ~~set~~States ~~forth~~Patent ~~in the Merger Agreement, at the first effective time, Merger Sub I will be merged with~~ and ~~into~~Trademark ~~Inmagene~~Office with Inmagene surviving as our wholly-owned subsidiary, and at the second effective time, Inmagene will be merged with and into Merger Sub II with Merger Sub II surviving as our wholly-owned subsidiary (~~the~~ “~~Merger~~USPTO”).

~~Subject~~in toissuing the ~~terms~~patent. ~~and~~However, ~~conditions~~with respect to patent term extensions granted as a result of the ~~Merger~~FDA ~~Agreement~~regulatory review period, atthe restoration period cannot be longer than five years, the ~~closing~~total ofpatent term including the ~~Merger~~restoration ~~and~~period ~~related~~must ~~transactions~~not exceed 14 years following FDA approval, ~~(a)~~only one patent applicable to each ~~then-outstanding~~regulatory ~~share~~review ofperiod ~~Inmagene~~may ~~(including~~be ~~shares~~extended ofand ~~Inmagene~~only ~~ordinary~~those ~~shares~~claims ~~issued~~covering ~~upon~~the ~~conversion~~approved ofdrug ~~Inmagene~~or ~~preferred~~a ~~shares)~~method ~~will~~for using it may be ~~converted~~extended. ~~into~~We may not receive an extension if we fail to exercise due diligence during the ~~right~~testing phase or regulatory review process, fail to ~~receive~~apply awithin ~~number~~applicable ofdeadlines, ~~shares~~fail to apply prior to expiration of ~~our~~relevant ~~common~~patents ~~stock~~or ~~calculated~~otherwise infail ~~accordance~~to ~~with~~satisfy ~~the~~applicable ~~Merger~~requirements. ~~Agreement~~Moreover, ~~and~~the ~~(b)~~length ~~each~~of ~~then-outstanding~~the ~~option~~extension tocould ~~purchase~~be ~~Inmagene~~less ~~ordinary~~than ~~shares~~we ~~will~~request. There can be ~~converted~~no ~~into~~assurance anthat ~~option~~we towill ~~purchase~~benefit ~~our~~from ~~common~~any ~~stock,~~patent ~~subject~~term toextension or favorable adjustment asto ~~set~~the ~~forth~~term inof ~~the~~any ~~Merger~~of ~~Agreement.~~our patents.

The ~~closing~~duration of ~~the~~foreign ~~Merger~~patents isvaries ~~subject~~in toaccordance ~~approval~~with byprovisions ~~our~~of ~~stockholders~~applicable ~~and~~local ~~shareholders~~law ofbut ~~Inmagene~~typically asis ~~well~~also as20 ~~other~~years ~~customary~~from ~~closing~~the ~~conditions.~~earliest Ifeffective ~~the~~filing ~~Merger~~date. ~~is completed~~However, the ~~business~~actual ofprotection ~~the~~afforded ~~combined~~by ~~company~~a ~~will~~patent bevaries ~~centered~~on ~~around~~a ~~advancing Inmagene’s lead~~ product-by-product ~~candidate~~basis, ~~IMG-007,~~from incountry ~~atopic~~to ~~dermatitis~~country, and ~~additional~~depends ~~immunology~~upon ~~and~~many ~~inflammatory~~factors, ~~indications.~~including ~~Any~~the ~~failure~~type toof ~~satisfy a required condition to closing may prevent~~patent, ~~delay or otherwise materially and adversely affect~~ the ~~completion~~scope of ~~the~~its ~~Merger~~coverage, ~~which~~the ~~could~~availability ~~materially~~of ~~and~~regulatory ~~adversely~~related ~~affect~~extensions, ~~our~~the ~~results~~availability of ~~operations,~~legal ~~business,~~remedies ~~financial~~in ~~results~~a ~~and/or~~particular ~~stock~~country ~~price.~~and Wethe ~~cannot~~validity ~~predict~~and ~~with~~enforceability ~~certainty whether or when any~~ of the ~~required~~patent. ~~closing~~As ~~conditions~~a ~~will~~result, beour ~~satisfied~~owned orand iflicensed ~~another~~patent ~~uncertainty~~portfolio may ~~arise~~not ~~and~~provide ~~cannot~~us ~~assure~~with ~~you~~sufficient ~~that~~rights ~~the~~to ~~proposed~~exclude ~~Merger~~others ~~will~~from becommercializing ~~successfully~~products ~~consummated~~similar or ~~that~~identical ~~we will be able~~ to ~~successfully consummate the proposed Merger as currently contemplated under the Merger Agreement or at all~~ours.

~~Risks~~If ~~related~~we do not adequately protect our intellectual property, third parties, including our competitors, may be able to ~~the~~use ~~failure~~our technologies to ~~consummate,~~produce and market drugs or ~~delay~~diagnostic inand/or ~~consummating,~~prognostic ~~the~~products ~~proposed~~in ~~Merger~~direct competition with ~~Inmagene~~us ~~include,~~and ~~but~~erode our competitive advantage. The patent positions of biotechnology and pharmaceutical products and processes like those we may develop and commercialize are ~~not~~generally ~~limited~~uncertain ~~to,~~and ~~the~~involve ~~following:~~complex legal and factual questions

we would not realize any or all of the potential benefits of the Merger, which could have a negative effect on our results of operations, business or stock price;

under some circumstances, we may be required to pay a termination fee to Inmagene of $5.0 million, with expense reimbursement of up to $1.0 million credited against the payment of any such termination fee;

we would remain liable for significant transaction costs, including legal, accounting, financial advisory and other costs relating to the Merger regardless of whether the Merger is consummated;

the trading price of our common stock may decline to the extent that the current market price for our common stock reflects a market assumption that the Merger will be completed;

the attention of our management and employees may have been diverted to the Merger rather than to our historical operations and the pursuit of other opportunities that could have been beneficial to us;

we could be subject to litigation related to any failure to complete the Merger;

we could potentially lose key personnel during the pendency of the Merger; and

~~under~~Table ~~the Merger Agreement, we are subject to certain customary restrictions on the conduct~~ of ~~our business prior to completing the Merger, which restrictions could adversely affect our ability to conduct our business as we otherwise would have done if we were not subject to these restrictions.~~ Contents

~~The~~that ~~occurrence~~may ofdiminish ~~any~~our ofability ~~these~~to ~~events~~protect ~~individually~~our orintellectual inproperty. ~~combination~~For ~~could~~more ~~materially~~information ~~and~~regarding ~~adversely~~risks ~~affect~~related to our ~~results~~intellectual ~~of operations~~property, ~~business,~~see ~~and~~“Risk ~~our~~Factors—Risks ~~common~~Related ~~stock~~to ~~price.~~Our Intellectual Property.”

IfRapidly weevolving dopatent ~~not~~laws ~~successfully~~in ~~consummate~~ the ~~Merger~~United orStates ~~another~~and ~~strategic~~elsewhere ~~transaction,~~make ~~our~~it ~~board~~difficult ofto ~~directors~~predict ~~may~~the ~~decide~~breadth toof ~~pursue~~claims athat ~~dissolution~~may ~~and~~be ~~liquidation~~allowed ofor enforced in our ~~company~~patents. InMoreover, ~~such~~patent anoffices ~~event,~~in ~~the~~general ~~amount~~can ofrequire ~~cash~~that ~~available~~patent ~~for~~applications ~~distribution~~concerning topharmaceutical ~~our~~and/or ~~stockholders~~biotechnology-related ~~will~~inventions ~~depend~~be ~~heavily~~limited onor narrowed substantially to cover only the ~~timing~~specific ofinnovations ~~such~~exemplified ~~liquidation~~in asthe ~~well~~patent asapplication, thereby limiting the ~~amount~~scope of ~~cash~~protection ~~that~~against ~~will~~competitive ~~need~~challenges. toThus, beeven ~~reserved~~if ~~for~~we ~~commitments~~are ~~and~~able ~~contingent~~to ~~liabilities~~obtain patents, asthe topatents ~~which~~may webe ~~can~~substantially ~~give~~narrower ~~you~~than ~~no assurance~~anticipated.

~~There~~Our ~~can~~ability beto nomaintain ~~assurance~~and ~~that~~defend ~~the Merger will be completed. If the Merger is not completed,~~ our ~~board~~intellectual ofproperty ~~directors may decide to pursue a dissolution~~ and ~~liquidation~~proprietary ofposition for our ~~company. In such an event~~products, ~~the~~product ~~amount~~candidates ofand ~~cash~~other ~~available~~technologies ~~for distribution to our stockholders~~ will depend ~~heavily~~ on ~~the~~our ~~timing~~success ofin ~~such~~obtaining ~~decision~~effective claims and, ~~ultimately,~~enforcing ~~such~~those ~~liquidation,~~claims ~~since~~once ~~the~~granted. ~~amount~~We ofdo ~~cash~~not ~~available~~know ~~for~~whether ~~distribution~~any ~~continues~~of tothe ~~decrease~~patent asapplications that we ~~fund~~may ~~our~~file ~~operations~~or ~~while~~license ~~pursuing~~from ~~the~~third ~~Merger.~~parties Inwill ~~addition,~~result ifin ~~our~~the ~~board~~issuance of ~~directors~~any ~~were~~patents. toThe ~~approve~~issued ~~and~~patents ~~recommend,~~that ~~and~~we ~~our~~own ~~stockholders~~or ~~were~~license tomay ~~approve,~~receive ain ~~dissolution and liquidation of~~ the ~~company~~future, weor ~~would~~license befrom ~~required~~third ~~under~~parties ~~Delaware~~may ~~corporate~~be ~~law~~challenged, toinvalidated, ~~pay~~held ~~our outstanding obligations~~unenforceable, asnarrowed ~~well~~or ascircumvented, ~~to make reasonable provision for contingent~~ and ~~unknown~~the ~~obligations,~~rights ~~prior~~granted tounder ~~making~~ any ~~distributions~~issued inpatents ~~liquidation to stockholders. Our commitments and contingent liabilities~~ may ~~include~~not ~~obligations~~provide ~~under~~us ~~our~~with ~~employment~~proprietary ~~and~~protection ~~related agreements~~ or ~~policies~~competitive ~~with~~advantages ~~certain~~against ~~employees~~third ~~that~~parties, ~~provide~~including ~~for~~our ~~severance~~competitors, ~~and~~with ~~other~~similar ~~payments~~technology. ~~following~~Furthermore, athird ~~termination of employment occurring for various reasons~~parties, including aour ~~change in control of the company~~competitors, ~~litigation~~may ~~against~~be ~~us,~~able ~~and~~to ~~other~~independently ~~various~~develop ~~claims~~ and ~~legal~~commercialize ~~actions~~similar ~~arising~~drugs inor ~~the~~products, ~~ordinary~~or ~~course~~duplicate ofour ~~business~~technology, ~~and~~business ~~other~~model ~~unexpected and/~~or ~~contingent~~strategy ~~liabilities.~~without Asinfringing ~~a result of this requirement, a portion of~~ our ~~assets would need to be reserved pending the resolution of such obligations~~patents.

InTrade addition, we may be subject to litigation or other claims related to a dissolution and liquidation of our company. If a dissolution and liquidation were to be pursued, our board of directors, in consultation with our advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of our common stock could lose all or a significant portion of their investment in the event of a liquidation, dissolution or winding up of the company. A liquidation would be a lengthy and uncertain process with no assurance of any value ever being returned to our stockholders.Secrets

We also rely upon unpatented trade secrets and know-how and continuing technological innovation to develop, protect and maintain our competitive position and aspects of our business that are ~~substantially~~not ~~dependent~~amenable onto, or that we do not presently consider appropriate for, patent protection and prevent competitors from reverse engineering or copying our ~~remaining~~technologies. However, the foregoing rights are difficult to protect. We seek to protect our proprietary information, in part, using confidentiality agreements with our commercial partners, collaborators, employees and consultants and invention assignment agreements with our employees. We also have confidentiality agreements or invention assignment agreements with our commercial partners and selected consultants. These agreements are designed to ~~facilitate~~protect our proprietary information and, in the ~~consummation~~case of the ~~Merger~~invention assignment agreements, to grant us ownership of technologies that are developed through a relationship with a third party. These agreements may be breached, and we may not have adequate remedies for any breach. There can be no assurance that these agreements will provide meaningful protection for our trade secrets or other intellectual property or proprietary information. In addition, our trade secrets may otherwise become known or be independently discovered by third parties, including our competitors. To the extent that our partners, collaborators, employees and consultants 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 more information regarding risks related to our trade secrets, see “Risk Factors—Risks Related to Our Intellectual Property.”

~~Our~~Data ~~ability~~privacy to consummate a strategic transaction depends upon our ability to retain our remaining employees required to consummate such a transaction, the loss of whose services may adversely impact the ability to consummate such transaction. In January and May 2024, we undertook a strategic realignment that significantly reduced our workforce in order to conserve our capital resources. As of February 28, 2025, we had only 10 full-time employees. Our ability to successfully complete the Merger depends in large part on our ability to retain these remaining personnel. Despite our efforts to retain these employees, one or more may terminate their employment with us on short notice. Our cash conservation activities may yield other unintended consequences, such as reduced employee morale, which may cause remaining employees to seek alternative employment. The loss of the services of certain employees could potentially harm our ability to consummate the Merger, to run our day-to-day business operations, as well as to fulfill our reporting obligations as a public company. security

~~Even~~In ifthe ordinary course of our business, we ~~are~~and ~~successful~~the inthird ~~completing~~parties awith ~~strategic~~whom ~~transaction~~we work process personal and sensitive data. Accordingly, we are 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. For example, the EU GDPR (as defined below), the UK GDPR (as defined below), Australia’s Privacy Act, and China’s PIPL (as defined below) impose strict requirements for processing personal data. Obligations related to data privacy and security (and individuals’ data privacy expectations) are quickly changing, becoming increasingly stringent, and creating uncertainty. Additionally, these obligations may be ~~exposed~~subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. Cyber-attacks, malicious internet-based activity, online and offline fraud, and other ~~operational~~similar activities threaten the confidentiality, integrity, and ~~financial~~availability ~~risks~~of our sensitive information and information technology systems, and those of the third parties with whom we work (including our current and future contract research organizations (“CROs”). Such threats are prevalent, 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, including via advanced persistent threat intrusions. If we (or the third parties with whom we work) experience a security incident or are perceived to have experienced a security incident, we could face adverse consequences.

Although there can be no assurance that a strategic transaction will result from the process we have undertaken to identify and evaluate strategic alternatives, the negotiation and consummation of any such transaction will require significant time on the part of our management, and the diversion of management’s attention may disrupt our business.

The negotiation and consummation of any such transaction may also require more time or greater cash resources than we anticipate and exposes us to other operational and financial risks, including:

increased near-term and long-term expenditures;

exposure to unknown liabilities;

higher than expected transaction costs;

difficulty and cost in combining the operations and personnel of any acquired business with our operations and personnel;

impairment of relationships with third parties of any acquired business due to changes in management and ownership;

inability to retain our key employees or those of any acquired business; and

~~possibility~~Table of ~~future litigation.~~Contents

~~Any~~See ofthe sections titled “Risk Factors—Risks Related to Government Regulation” and “Risk Factors—Risks Related to our Industry and Business” for additional information about the ~~foregoing~~privacy ~~risks~~and ~~could~~security ~~have~~obligations ato ~~material~~which ~~adverse~~we ~~effect~~are onand may become subject and about the risks to our business, ~~financial~~associated ~~condition~~with ~~and~~such ~~prospects~~obligations.

~~If we do not complete the Merger, we may face substantial competition for attractive counterparties for any proposed strategic transactions.~~ Manufacturing

~~There~~We ~~can~~do benot noown ~~assurance~~or ~~that~~operate ~~the~~and ~~Merger~~currently ~~will~~have beno ~~completed.~~plans Ifto ~~the~~establish ~~Merger~~any ismanufacturing ~~not~~facilities. ~~completed,~~We ~~our~~rely ~~board~~on ofand ~~directors~~expect ~~may~~to ~~decide~~continue to ~~pursue~~rely anon ~~alternative~~third-party ~~strategic~~contract ~~transaction.~~development Weand ~~may~~manufacturing ~~face~~organizations ~~substantial~~(“CDMOs”) ~~competition~~ for ~~attractive~~the ~~counterparties~~manufacturing ~~for~~of ~~any~~our ~~proposed~~product ~~strategic~~candidate ~~transactions.~~and ~~For~~related ~~example,~~raw ~~there~~materials ~~may~~for beclinical ~~many~~development, ~~other~~as ~~biotechnology~~well ~~and~~as ~~pharmaceutical~~for ~~companies~~the ~~that~~commercial ~~halt~~manufacturing ~~development~~ of ~~their~~any ~~programs~~of ~~and~~our ~~instead~~product ~~choose~~candidate tothat ~~pursue~~receive ~~strategic~~marketing ~~transactions~~approval ~~like~~in the ~~ones~~future. weWe ~~have~~currently ~~been~~solely ~~exploring~~rely inon ~~connection~~Wuxi ~~with~~Biologics ~~our~~to ~~strategic~~provide ~~review~~biological ~~process~~development and manufacturing services. ~~These~~We ~~companies~~believe ~~may~~there ~~possess~~are ~~greater~~multiple ~~financial~~sources ~~and~~for ~~managerial~~all ~~resources~~of ~~than~~the wematerials ~~do,~~required for the manufacturing of our product candidate and ~~they~~development program and may ~~have~~in ~~more~~the ~~attractive~~future ~~product~~engage ~~candidates,~~additional ~~intellectual~~CDMOs ~~property~~to orprovide ~~other~~biological ~~assets~~development and manufacturing services. As aour ~~result,~~product ~~these~~candidate ~~other~~advances ~~companies~~through ~~may~~development, ~~prove~~we expect to beenter ~~more~~into ~~attractive~~longer-term ~~than~~commercial ussupply toagreements ~~counterparties~~with ~~pursuing~~key ~~strategic~~suppliers ~~transactions.~~and ~~There~~manufacturers ~~can~~to befulfill noand ~~assurance~~secure ~~that~~our ~~its~~production ~~strategic~~needs. ~~review~~If ~~process~~our ~~will~~current ~~result~~CDMO inbecomes unavailable to us ~~pursuing~~for aany ~~transaction~~reason, orwe believe that ~~any~~there ~~transaction,~~are ifa ~~pursued,~~number ~~will~~of bepotential ~~completed~~replacements, onand ~~terms~~we ~~favorable~~will need to usidentify and ~~our~~qualify ~~stockholders.~~such replacements.

We ~~have~~also ~~never~~rely ~~paid~~on CDMOs to perform all chemistry, manufacturing, and controls activities. Our agreements with CDMOs may obligate them to develop or transfer upstream and downstream processes, ~~other~~develop ~~than~~or intransfer ~~connection~~drug product manufacturing processes, develop or transfer suitable analytical methods for release and stability testing and qualify these methods for use with ~~the~~our ~~Merger~~product candidates, doproduce ~~not~~drug ~~intend~~substance tofor ~~pay~~preclinical ~~any~~testing, ~~cash~~and ~~dividends~~produce drug substance or drug product under current Good Manufacturing Practice (“cGMP”) for use in ~~the~~clinical ~~foreseeable~~trials ~~future~~among other activities. In addition, sowe ~~any~~rely ~~returns~~on ~~will~~CDMOs beto ~~limited~~operate facilities that meet regulatory requirements for production and testing of clinical and commercial products and to ~~the~~work ~~value~~closely with us to validate manufacturing processes prior to commercial launch. We qualify CDMOs prior to initiation of ~~our~~cGMP ~~capital~~regulated ~~stock~~activities and periodically thereafter as part of the supplier qualification program. We oversee CDMOs by performing technical and quality assurance review and/or approval of cGMP documentation, establishing quality agreements to define responsibilities and expectations for goods and services, and observing production and testing activities as a person-in-plant, among other activities.

WeSales ~~have never paid cash dividends on any of our capital stock. We currently anticipate that we will retain future earnings~~ and do not anticipate declaring or paying any cash dividends for the foreseeable future, other than any dividend contemplated under the Merger Agreement. In addition, we may enter into agreements that prohibit us from paying cash dividends without prior written consent from our contracting parties, or with other terms prohibiting or limiting the amount of dividends that may be declared or paid on our common stock. Any return to stockholders will therefore be limited to the appreciation of their stock, which may never occur. Marketing

WeAs ~~may~~our ~~become~~product ~~involved~~candidate inadvances ~~litigation~~through development, ~~including~~we ~~securities~~expect ~~class~~to ~~action~~establish ~~litigation,~~a commercial strategy which ~~could~~will ~~divert~~be ~~management’s~~focused ~~attention~~on ~~and~~maximizing ~~harm~~the value of our ~~business,~~product ~~and~~by ~~insurance~~either ~~coverage~~entering ~~may~~into ~~not~~collaborations bewith ~~sufficient~~commercial tostage ~~cover~~pharmaceutical ~~all~~companies ~~costs~~or building an in-house commercial organization and ~~damages.~~retaining commercialization rights to our product candidate in full or in certain therapeutics indications or geographies.

InSummary ~~the past, litigation, including securities class action litigation, has often followed certain significant business transactions, such as the sale~~ of aLicense company or announcement of any other strategic transaction, or the announcement of negative events, such as negative results from clinical trials. These events may also result in investigations by the SEC. We may be exposed to such litigation even if no wrongdoing occurred. Litigation is usually expensive and ~~diverts~~Collaboration management’s attention and resources, which could adversely affect our business and cash resources and our ability to consummate a potential strategic transaction or the ultimate value its stockholders receive in any such transaction. Agreements

~~Risks~~Hutchmed ~~Related to Our Limited Operating History~~Collaboration, ~~Financial~~Option ~~Position,~~ and ~~Capital~~License ~~Requirements~~ Agreement

WeIn ~~are~~January a2021, ~~targeted~~we ~~oncology~~entered ~~company~~into the Hutchmed Agreement (as defined below), pursuant to which Hutchmed granted us the exclusive option to the worldwide license with athe ~~limited~~right ~~operating~~to ~~history~~sublicense to develop, manufacture and commercialize several licensed compounds including humanized antagonistic OX40 receptor mAb (IMG-007) (the “Licensed Compounds”) for the treatment or prevention of all diseases and conditions except oncology. The exclusive option was granted on a Licensed Compound-by-Licensed Compound basis, exercisable at our sole discretion upon payment of an option exercise fee in cash or the issuance of our ordinary shares.

WeOn ~~commenced~~February ~~operations~~2, in2024, ~~2016~~we ~~and~~exercised ~~are~~the aoption ~~targeted~~under ~~oncology~~the ~~company~~Hutchmed ~~with~~Agreement aby ~~limited~~entering ~~operating~~into ~~history. Biopharmaceutical product development is~~ a ~~highly~~share ~~speculative~~subscription ~~undertaking~~agreement ~~and~~to ~~involves~~issue ~~a substantial degree of risk. Since our inception~~429,082 weshares ~~have devoted substantially all~~ of our ~~efforts~~common stock to ~~organizing~~Hutchmed and ~~staffing~~obtained ~~our~~an ~~company~~exclusive, ~~acquiring intellectual property~~worldwide, ~~business~~royalty-bearing ~~planning,~~license ~~raising~~with ~~capital,~~the ~~conducting~~right ~~discovery,~~to ~~research~~sublicense ~~and~~through ~~development~~multiple ~~activities~~tiers, ~~and~~under ~~providing~~certain ~~general~~patents and ~~administrative~~know-how ~~support~~controlled ~~for~~by ~~these~~Hutchmed ~~operations. We have no products approved for commercial sale~~ and ~~therefore,~~Hutchmed’s ~~have never generated any revenue from product sales~~right, ~~and~~title ~~we do not expect to in the foreseeable future. We have not obtained regulatory approvals for any of our product candidates,~~ and ~~there~~interest ~~is no assurance that we will obtain approvals~~ in the ~~future.~~joint Ifintellectual weproperty ~~continue~~ to ~~progress the development of our product candidates~~develop, wemanufacture ~~expect to continue to incur expenses~~ and ~~operating~~commercialize ~~losses~~any ~~for~~product ~~the~~that ~~foreseeable future. Our prior losses~~contains, ~~combined with expected future losses~~incorporates, ~~have~~or ~~had~~otherwise ~~and~~includes ~~will~~the ~~continue~~humanized toOX40 ~~have~~antagonistic anmonoclonal ~~adverse~~antibody ~~effect~~(anti-OX40 onmAb) ~~our~~(“Licensed ~~stockholders’ equity and working capital~~Product”).

Under the Hutchmed Agreement, we are required to pay an aggregate of up to $92.5 million for each Licensed Product upon the achievement of various development, regulatory and commercialization milestones with respect to such

WeTable ~~have incurred significant net losses since our inception and, if we continue to progress the development~~ of ~~our product candidates, anticipate that we will continue to incur losses for the foreseeable future.~~ Contents

~~Our~~Licensed ~~net~~Product, ~~losses were~~ $4920.20 million ~~and~~of ~~$68.2~~which ~~million~~would ~~for~~be ~~the~~due ~~years~~prior ~~ended~~to ~~December~~the ~~31,~~first ~~2024~~approval ~~and~~of ~~2023,~~a ~~respectively.~~Licensed WeProduct ~~had~~in anthe ~~accumulated~~United ~~deficit~~States, ofand ~~$331.6~~an ~~million~~aggregate as of ~~December~~up ~~31,~~to ~~2024~~$135.0 ~~Substantially~~million ~~all~~for ofeach ~~our~~Licensed ~~net~~Compound ~~losses~~upon ~~have~~the ~~resulted~~achievement ~~from~~of ~~costs~~various ~~incurred~~worldwide inaggregate ~~connection~~cumulative ~~with~~annual ~~our~~net ~~research~~sales ~~and~~milestones ~~development~~for ~~programs~~the ~~and~~Licensed ~~from~~Products ~~general~~that ~~and~~contain ~~administrative~~such ~~costs~~Licensed ~~associated with our operations~~Compound. IfWe weare ~~continue~~also obligated to ~~progress~~pay ~~the~~tiered ~~development~~royalty ofrates ~~our~~in ~~product~~the ~~candidates,~~high wesingle-digit ~~expect~~to ~~that~~low ~~our~~tens ~~research~~percentages ~~and~~to ~~development~~Hutchmed ~~expenses~~on ~~could~~a ~~increase~~Licensed ~~significantly.~~Compound-by-Licensed InCompound ~~addition,~~basis iffor wenet ~~obtain~~sales ~~regulatory~~of ~~approval~~such ~~for~~Licensed ~~our~~Compounds ~~product candidates~~worldwide, wesubject ~~will~~to ~~incur~~reduction ~~significant~~in ~~sales,~~certain ~~marketing, and manufacturing expenses~~circumstances. AsRoyalties ~~a public company, we~~ will ~~continue~~be topayable ~~incur~~on ~~additional~~a ~~costs~~Licensed ~~for~~Product-by-Licensed ~~the~~Product ~~foreseeable~~and ~~future~~country-by-country ~~that~~basis wefor ~~did~~a ~~not~~period ~~incur~~commencing asupon athe ~~private~~first ~~company.~~commercial ~~Because~~sale of the ~~numerous~~Licensed ~~risks~~Product ~~and~~in ~~uncertainties~~such ~~associated~~country ~~with~~and ~~developing~~continuing ~~pharmaceutical~~until ~~products,~~the welater ~~are~~of ~~unable~~(a) ~~to predict~~ the ~~extent~~expiration of ~~any future losses or when we will become profitable, if at~~ all. ~~Even~~valid ifpatent weclaims door ~~become~~regulatory ~~profitable,~~exclusivity wecovering ~~may~~the ~~not~~Licensed beProduct ~~able~~in tosuch ~~sustain~~country orand ~~increase~~(b) ~~our~~10 ~~profitability~~years onafter asuch ~~quarterly~~first orcommercial ~~annual basis~~sale.

The ~~amount~~Hutchmed ofAgreement ~~our~~will ~~future~~remain ~~losses~~in iseffect ~~uncertain~~until ~~and~~the ~~our~~expiration ~~quarterly~~of all royalty payment obligations on a country-by-country and ~~annual~~Licensed ~~operating~~Product-by-Licensed ~~results~~Product basis, and may ~~fluctuate~~be ~~significantly~~earlier orterminated ~~may~~by ~~fall~~either ~~below~~party for the ~~expectations~~other ofparty’s ~~investors~~uncured material breach or ~~securities~~insolvency. ~~analysts~~In addition, ~~each~~Hutchmed may terminate the Hutchmed Agreement if we challenge any of ~~which~~the ~~may~~licensed ~~cause~~patents, ~~our~~or ~~stock~~terminate ~~price~~the Hutchmed Agreement with respect to ~~fluctuate~~a orparticular ~~decline.~~Licensed IfCompound if we ~~continue~~do tonot ~~progress~~conduct ~~the~~any material development or commercialization activities for a specified period of ~~our~~time ~~product~~after ~~candidates,~~we ~~our~~exercise ~~quarterly~~the ~~and~~applicable ~~annual~~exclusive ~~operating~~option, ~~results~~and ~~may~~we ~~fluctuate~~have ~~significantly~~the inright to terminate the ~~future~~Hutchmed ~~due~~Agreement tofor aconvenience ~~variety~~upon ofadvance ~~factors,~~notice ~~many~~to ofHutchmed. ~~which~~For ~~are~~more ~~outside~~information ofon ~~our~~the ~~control~~patent ~~and~~family ~~may~~licensed befrom ~~difficult~~Hutchmed tounder ~~predict~~the Hutchmed Agreement, ~~including~~see the ~~following:~~section titled “—IP Overview.”

~~our~~Cell ~~ability~~Line toLicense ~~attract,~~Agreement ~~hire,~~with ~~and~~WuXi ~~retain~~Biologics ~~qualified personnel as necessary;~~

In February 2021, we and WuXi Biologics (Hong Kong) Limited (“WuXi Biologics”) entered into a Cell Line License Agreement (the ~~timing~~“Cell Line License Agreement”). Under the Cell Line License Agreement, we received a non-exclusive, worldwide, conditionally sublicensable license to certain of WuXi Biologics’ know-how, cell line, biological materials and ~~success~~media orand ~~failure~~feeds (the “WuXi Biologics Licensed Technology”) to make, have made, use, sell and import certain therapeutic products produced through the use of ~~clinical~~the ~~trials~~cell ~~for~~line licensed by WuXi Biologics under the Cell Line License Agreement (the “WuXi Biologics Licensed Products”). Specifically, the WuXi Biologics Licensed Technology is used to manufacture a component of our ~~product~~IMG-007 ~~candidates~~program. orIn ~~competing~~consideration ~~product~~of ~~candidates~~the license, orwe ~~any~~agreed to pay WuXi Biologics a non-refundable license fee of $150,000. Additionally, if we manufacture all of our commercial supplies of WuXi Biologics Licensed Products with a manufacturer other ~~change~~than WuXi Biologics or its affiliates, we are required to make royalty payments to WuXi Biologics in ~~the~~an ~~competitive~~amount ~~landscape~~equal a fraction of a single digit percentage of global net sales of WuXi Biologics Licensed Products manufactured by a third-party manufacturer. The Cell Line License Agreement will continue indefinitely unless terminated (i) by us upon a certain time period’s prior written notice and our ~~industry~~payment of all undisputed amounts due to WuXi Biologics through the effective date of termination, ~~including~~(ii) ~~consolidation~~by ~~among~~either ~~our~~party ~~competitors~~for a material breach by the other party that remains uncured for certain a period of time after written notice, or ~~partners;~~(iii) by WuXi Biologics if we fail to make a payment and such failure continues for a certain period of time after receiving notice of such failure.

~~our~~Relevant ~~ability~~law ~~to successfully open clinical trial sites~~ and ~~recruit and retain subjects for clinical trials, and any delays caused by difficulties in such efforts;~~ regulations

~~our~~U.S. ~~ability~~Biologic toDevelopment ~~obtain regulatory approval for our product candidates, and the timing and scope of any such approvals we may receive;~~ Process

In the ~~timing~~United States, the FDA regulates biologics under the federal Food, Drug, and ~~cost~~Cosmetic ofAct, the Public Health Service Act (“PHSA”) and ~~level~~their implementing regulations. The process of ~~investment~~obtaining ~~in,~~regulatory ~~research~~approvals and ~~development~~the ~~activities~~subsequent ~~relating~~compliance towith ~~our~~appropriate ~~product~~federal, ~~candidates~~state, ~~which~~local ~~may~~and ~~change~~foreign ~~from~~statutes ~~time~~and toregulations require the expenditure of substantial time; and financial resources. The process required by the FDA before a biologic may be marketed in the United States generally involves the following:

•

~~the~~completion ~~cost~~ of ~~manufacturing~~preclinical ~~our~~laboratory ~~product candidates and products~~tests, ~~should~~animal ~~they~~studies ~~receive regulatory approval, which may vary depending on the quantity of production~~ and ~~the~~formulation ~~terms~~studies ofin ~~our~~accordance ~~agreements~~ with ~~manufacturers;~~FDA’s ~~expenditures~~GLP ~~that~~(as wedefined ~~may~~below) ~~incur~~requirements toand ~~develop~~other ~~product~~applicable ~~candidates~~regulations;

•

submission to the ~~level~~FDA of ~~demand~~an ~~for~~Investigational ~~our~~New ~~products~~Drug ~~should~~(“IND”) ~~they~~application ~~receive~~which ~~regulatory~~must ~~approval,~~become ~~which~~effective ~~may~~before ~~vary~~human ~~significantly;~~clinical trials may begin;

•

~~the~~approval ~~risk/benefit~~by ~~profile,~~an ~~cost~~independent ~~and~~institutional ~~reimbursement~~review ~~policies~~board ~~with~~(“IRB”) ~~respect~~or toethics ~~our~~committee ~~product~~at ~~candidates,~~each ifclinical ~~approved,~~site ~~and~~before ~~existing~~each ~~and~~trial ~~potential~~may ~~future~~be ~~therapeutics that compete with our product candidates~~initiated;

•

~~the~~performance ~~changing~~of adequate and ~~volatile~~well-controlled ~~U.S.~~human ~~and~~clinical ~~global~~trials ~~economic~~in ~~environments;~~accordance with good clinical practices (“GCPs”) to establish the safety, purity and potency of the proposed biologic for its intended use;

future accounting pronouncements or changes in our accounting policies.

The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially. Such a stock price decline could occur even when we have met any previously publicly stated guidance we may provide.

We have no products approved for commercial sale and have not generated any revenue from product sales.

Our ability to become profitable depends upon our ability to generate revenue. To date, we have generated minimal collaborative revenue from our product candidates and have not generated revenue from product sales, and we do not expect to generate any revenue from the sale of products in the near future. We do not expect to generate significant revenue unless and until we obtain regulatory approval of, and begin to sell, one or more of our product candidates. If we continue to progress the development of our product candidates, our ability to generate revenue will depend on a number of factors, including, but not limited to, our ability to:

successfully complete clinical studies for our IK-595 program;

~~timely~~Table ~~file and obtain clearance~~ of ~~INDs by the FDA or comparable clinical trial applications by foreign regulatory authorities, for any programs in order to commence future clinical trials;~~ Contents

•

~~successfully~~preparation ~~enroll~~of ~~subjects~~and ~~in,~~submission ~~and~~to ~~complete,~~the ~~our~~FDA ~~ongoing~~of ~~clinical~~a ~~trial;~~BLA (as defined below) after completion of all pivotal trials;

•

~~initiate~~a ~~and~~determination ~~successfully~~by ~~complete~~the ~~all~~FDA ~~safety~~within ~~and~~60 ~~efficacy~~days ~~studies~~of ~~required~~its toreceipt ~~obtain~~of ~~U.S.~~a ~~and~~BLA ~~foreign~~to ~~regulatory~~file ~~approval~~the application for ~~our product candidates~~review;

•

~~establish~~satisfactory ~~commercial~~completion ~~manufacturing~~of ~~capabilities~~an orFDA ~~make~~advisory ~~arrangements~~committee ~~with~~review, ~~third-party~~if ~~manufacturers for clinical supply and commercial manufacturing~~applicable;

•

~~obtain~~satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with cGMP requirements to assure that the facilities, methods and ~~maintain~~controls ~~patent~~are adequate to preserve the drug’s identity, strength, quality and ~~trade~~purity, ~~secret~~and ~~protection~~of orselected ~~regulatory~~clinical ~~exclusivity~~investigation ~~for~~sites ~~our~~to ~~product~~assess ~~candidates~~compliance with GCPs; and

•

~~launch~~FDA ~~commercial~~review ~~sales~~and approval of ~~our~~the ~~products,~~BLA ifto ~~and~~permit ~~when~~commercial ~~approved,~~marketing ~~whether~~of ~~alone~~the orproduct infor ~~collaboration~~particular ~~with~~indications ~~others;~~for use in the United States.

~~obtain~~The ~~and~~preclinical ~~maintain~~developmental ~~acceptance~~stage ofgenerally ~~the~~involves ~~products~~laboratory evaluations of chemistry, ifformulation and ~~when approved~~stability, byas ~~patients,~~well as studies to evaluate the ~~medical~~product ~~community~~candidate’s toxicity in animals, in an effort to support subsequent clinical testing. The conduct of preclinical studies is subject to federal regulations and ~~third-party~~requirements, ~~payors;~~including GLP regulations.

~~position~~Prior ~~our~~to ~~products~~beginning tothe ~~effectively~~first ~~compete~~clinical trial with ~~other~~a ~~therapies;~~product candidate in the United States, the trial sponsor must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an investigational drug to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical trials. The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology and PD characteristics of the product candidate, chemistry, manufacturing and controls information, and any available human data or literature to support the use of the product candidate. An IND must become effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.

~~obtain~~Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control, in accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring subject safety and ~~maintain~~the ~~healthcare~~effectiveness ~~coverage~~criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and ~~adequate~~for ~~reimbursement;~~any subsequent protocol amendments. While the IND is active, progress reports summarizing the results of the clinical trials and pre-clinical studies performed since the last progress report, among other information, must be submitted at least annually to the FDA, and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected adverse events, findings from other studies suggesting a significant risk to humans exposed to the same or similar drugs, findings from animal or in vitro testing suggesting a significant risk to humans, and any clinically important increased incidence of a serious suspected adverse reaction compared to that listed in the protocol or investigator brochure.

~~enforce~~Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and ~~defend~~approve ~~intellectual~~the ~~property~~plan ~~rights~~for any clinical trial and ~~claims;~~its informed consent form before the clinical trial begins at that site and must monitor the study until completed. Regulatory authorities, the IRB or 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 oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to certain 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, including clinicaltrials.gov.

maintain a continued acceptable safety profile of our products following approval.

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 commercialize our product candidates, which would materially harm our business. If we do not develop and receive regulatory approvals for our product candidates, we may not be able to continue our operations.

The development of pharmaceutical products is capital-intensive. We are conducting clinical trials for multiple product candidates. We expect our expenses to significantly increase if we continue to progress the development of our product candidates. In addition, depending on the status of regulatory approval or, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. We may also need to raise additional funds sooner if we choose to pursue additional indications and/or geographies for our current or future product candidates or otherwise expand more rapidly than we presently anticipate. We also continue to incur additional costs associated with operating as a public company. Accordingly, we may need to obtain additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce, or eliminate certain of our research and development or future commercialization efforts.

On May 17, 2023, we completed an underwritten registered offering (“URO”), of common stock pursuant to which we issued and sold 6,110,000 shares of our common stock at a purchase price of $6.55 per share. On August 4, 2023, we acquired Pionyr Immunotherapeutics, Inc. (“Pionyr”), in accordance with the terms of the Agreement and Plan of Merger, dated August 4, 2023 (the “Pionyr Merger Agreement”). Under the terms of the Pionyr Merger Agreement, at the closing of the acquisition, we acquired all of Pionyr’s assets, including approximately $48.0 million in net cash at the time of closing, and we issued the holders of Pionyr common stock a total of 1,800,652 shares of the our common stock (including 153,121 shares of our non-voting common stock) at the purchase price of $7.15 per share and 4,153,439 shares of Series A Preferred Stock, also at the purchase price of $7.15 per share, each share of which was subsequently converted into one share of the our common stock at a special shareholders meeting on October 11, 2023. As a result of the January Restructuring (as defined below) that we completed in the first quarter of 2024 and the May Restructuring (as defined below) that we completed in the third quarter of 2024, and the associated anticipated reduction in our operating expenses, we expect that our cash, cash equivalents and marketable securities are sufficient to fund our operations for at least 12 months following the date of this filing. However, our future capital requirements will depend on and could increase significantly as a result of many factors, including:

the scope, progress, results and costs of development and clinical trials for our product candidates;

the costs, timing, and outcomes of regulatory reviews of our product candidates;

our ability to establish and maintain additional collaborations on favorable terms, if at all;

~~the~~Table ~~achievement~~ of ~~milestones or occurrence of other developments that trigger payments under any collaboration agreements we may establish;~~ Contents

~~the~~Human ~~extent~~clinical totrials ~~which we~~ are ~~obligated~~typically toconducted ~~reimburse,~~in orthree ~~entitled~~sequential tophases ~~reimbursement~~that ~~of,~~may ~~clinical~~overlap ~~trial~~or ~~costs~~be ~~under future collaboration agreements, if any;~~ combined:

•

Phase 1: The product candidate is initially introduced into healthy human subjects or patients with the ~~costs~~target ofdisease ~~preparing~~or condition. These studies are designed to test the safety, ~~filing~~tolerability, absorption, metabolism, distribution and ~~prosecuting~~clearance ~~patent~~of ~~applications~~the investigational product in humans, ~~maintaining~~the ~~and~~side ~~enforcing~~effects ~~our~~associated ~~intellectual~~with ~~property~~increasing ~~rights~~doses, and, ~~defending~~if ~~intellectual~~possible, ~~property-related~~to ~~claims;~~gain early evidence on effectiveness.

•

~~the~~Phase ~~extent~~2: The product candidate is administered to ~~which~~a welimited ~~acquire~~patient population with a specified disease or ~~in-license~~condition ~~other~~to ~~product~~evaluate ~~candidates~~the preliminary efficacy, optimal doses, dose administration schedules and ~~technologies;~~to identify and characterize treatment emergent signs and symptoms 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.

•

~~the~~Phase ~~costs~~3: The product candidate is administered to an expanded patient population to further evaluate dose, to provide statistically significant evidence of ~~securing~~clinical ~~manufacturing~~efficacy ~~arrangements~~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 ~~commercial~~to ~~production;~~provide an adequate basis for product approval.

~~costs~~In ~~related~~some cases, the FDA may require, or sponsors may voluntarily pursue, additional clinical trials after a product is approved to gain more information about the ~~development~~product. ofThese ~~any~~so-called ~~companion~~Phase ~~diagnostics~~4 westudies, may ~~use~~be conducted after initial marketing approval, and may be used to gain additional experience from the treatment of patients in the ~~future;~~intended ~~and~~therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of a BLA.

Concurrently with clinical trials, companies usually complete additional pre-clinical studies and must also develop additional information about the ~~costs~~chemistry and physical characteristics of ~~establishing~~the ordrug ~~contracting~~and finalize a process for ~~sales~~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, ~~marketing~~among ~~capabilities~~other ifthings, wethe ~~obtain~~manufacturer ~~regulatory~~must ~~approvals~~develop methods for testing the identity, strength, quality and purity of the final drug. In addition, appropriate packaging must be selected and tested, and stability studies must be conducted to ~~market~~demonstrate ~~our~~that the product ~~candidates~~candidate does not undergo unacceptable deterioration over its shelf life.

~~Identifying~~In ~~potential~~addition, ~~product~~during ~~candidates~~the ~~and~~development ~~conducting~~of ~~preclinical~~a ~~development~~new ~~testing~~drug, ~~and~~sponsors ~~clinical~~are ~~trials~~given isopportunities ato ~~time-consuming,~~meet ~~expensive,~~with ~~and~~the ~~uncertain~~FDA ~~process~~at ~~that~~certain ~~takes~~points. ~~years~~These points may be prior to ~~complete~~submission of an IND, at the end of Phase 2, and webefore a BLA is submitted. Meetings at other times may ~~never~~be ~~generate~~requested. ~~the~~These ~~necessary~~meetings ~~data~~can orprovide ~~results~~an ~~required~~opportunity tofor ~~obtain~~the ~~regulatory~~sponsor ~~approval~~to ~~and~~share ~~achieve~~information ~~product~~about ~~sales.~~the Indata ~~addition~~gathered to date, ~~our~~for ~~product~~the ~~candidates~~FDA to provide advice, ifand ~~developed~~for the sponsor and ~~approved,~~the ~~may~~FDA ~~not~~to ~~achieve~~reach ~~commercial~~agreement ~~success.~~on ~~Commercial~~the ~~revenue,~~next ifphase ~~any,~~of ~~will~~development. beSponsors ~~derived~~typically ~~from~~use ~~sales~~the ofmeetings ~~products~~at ~~that~~the weend doof ~~not~~the ~~expect~~Phase 2 trial to bediscuss ~~commercially~~Phase ~~available~~2 ~~for~~clinical ~~many~~results ~~years,~~and ifpresent atplans ~~all.~~for ~~Accordingly,~~the wepivotal ~~may~~Phase ~~need~~3 toclinical ~~continue~~trials tothat ~~rely~~they onbelieve ~~additional~~will ~~financing~~support toapproval ~~achieve~~of ~~our~~the ~~business~~product ~~objectives~~candidate.

~~Any~~FDA ~~additional~~Review ~~fundraising~~& ~~efforts~~Approval may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. Disruptions in the financial markets in general and the recent volatility in the capital markets may make equity and debt financing more difficult to obtain and may have a material adverse effect on our ability to meet our fundraising needs. We cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.Process

IfFollowing wesuccessful completion of clinical trials, data are ~~unable~~analyzed to ~~obtain~~assess ~~funding~~whether onthe ainvestigational ~~timely~~product ~~basis~~is safe and effective for the proposed indicated use or onuses. ~~acceptable~~The ~~terms,~~results weof ~~may~~pre-clinical bestudies ~~required~~and clinical trials for a particular product candidate are then submitted to ~~significantly~~the ~~curtail~~FDA as part of a BLA, ~~delay~~along orwith ~~discontinue~~proposed labeling, chemistry and manufacturing information to ensure product quality and other relevant data. A BLA is a request for approval to market the biologic for one or more specified indications and must contain proof of ~~our~~safety, ~~research~~purity orand ~~development~~potency. ~~programs~~An orapplication ~~the~~may ~~commercialization~~include both negative and ambiguous results of ~~any~~pre-clinical ~~product~~studies ~~that~~and ~~has~~clinical ~~received~~trials, ~~regulatory~~as ~~approval~~well oras bepositive ~~unable~~findings. Data may come from company-sponsored clinical trials intended to ~~expand~~test ~~our~~the ~~operations~~safety orand ~~otherwise~~efficacy ~~capitalize~~of ona ~~our~~product’s ~~business~~use ~~opportunities~~or asfrom ~~desired~~a number of alternative sources, ~~which~~including ~~could~~trials ~~materially~~initiated ~~affect~~by ~~our~~investigators. ~~business~~To support marketing approval, ~~financial~~the ~~condition~~data submitted must be sufficient in quality and ~~results~~quantity to establish the safety, purity and potency of ~~operations~~an investigational product to the satisfaction of the FDA. FDA approval of a BLA must be obtained before a biologic may be marketed in the United States.

~~Raising~~Under ~~additional~~the ~~capital~~Prescription ~~may~~Drug ~~cause~~User ~~dilution~~Fee toAct ~~our stockholders~~(“PDUFA”), ~~restrict~~a ~~our~~BLA ~~operations~~must orbe ~~require~~accompanied usby toa ~~relinquish~~user ~~rights~~fee. toThe ~~our~~FDA ~~technologies~~adjusts orthe ~~product~~PDUFA ~~candidates~~user fees on an annual basis. Fee waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed by a small business.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of private and public equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other strategic transactions. We do not have any committed external source of funds. The terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. To the extent that we raise additional capital through the sale of common stock or securities convertible or exchangeable into common stock, our stockholders’ ownership interest will be diluted, and the terms of those securities may include liquidation or other preferences that may materially adversely affect our stockholders’ rights. Debt financing, if available, would increase our fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, acquiring, selling, or licensing intellectual property rights, and making capital expenditures, declaring dividends or other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to meet certain milestones in connection with debt financing and the failure to achieve such milestones by certain dates may force us to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us which could have a material adverse effect on our business, operating results, and prospects.

We also could be required to seek funds through arrangements with additional collaborators or otherwise at an earlier stage than otherwise would be desirable. If we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates, grant licenses on terms that may not be favorable to us or grant rights to develop and market our product candidates that we may otherwise develop and market ourselves, any of which may have a material adverse effect on our business, operating results and prospects.

~~Furthermore,~~Table ~~based on our public float as~~ of the date of the filing of this Annual Report on Form 10-K, and for so long as our public float is less than $75.0 million, the amount we can raise through primary public offerings of securities in any twelve-month period using shelf registration statements is limited to an aggregate of one-third of our public float pursuant to Instruction I.B.6. to Form S-3, which is referred to as the “baby shelf” rule.Contents

WeThe ~~have~~FDA ~~recently~~reviews ~~undertaken~~all ~~internal~~submitted ~~restructuring~~BLAs ~~activities~~before it accepts them for filing, and may dorequest soadditional ~~again~~information rather than accepting the BLA for filing. The FDA must make a decision on accepting a BLA for filing within 60 days of receipt, and such decision could include a refusal to file by the FDA. Once and if the submission is accepted for filing, the FDA begins an in-depth review of the ~~future~~BLA. Under the goals and policies agreed to by the FDA under PDUFA, the FDA targets ten months, from the filing date, in which to complete its initial review of an original BLA and respond to the applicant, and six months from the filing date of an original BLA designated for priority review. The ~~assumptions~~FDA ~~underlying~~does ~~these~~not ~~activities~~always meet its PDUFA goal dates for standard and priority BLAs, and the review process is often extended by FDA requests for additional information or clarification. Before approving a BLA, the FDA will conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether they comply with cGMP requirements. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. The FDA also may ~~prove~~audit data from clinical trials to ensure compliance with GCP requirements and confirm such data are intended to evaluate the integrity of clinical data. Additionally, the FDA may refer applications for novel products or products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be ~~inaccurate~~approved and under what conditions, if any. The FDA is not bound by recommendations of an advisory committee, but it considers such recommendations when making decisions on approval. The FDA likely will reanalyze the clinical trial data, which could result in extensive discussions between the FDA and the applicant during the review process. After the FDA evaluates a BLA, it will issue an approval letter or wea Complete Response Letter. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete, and the application will not be approved in its present form. A Complete Response Letter usually describes all of the specific deficiencies in the BLA identified by the FDA. The Complete Response Letter may ~~fail~~require the applicant to ~~achieve~~obtain additional clinical data, including the ~~expected~~potential ~~benefits~~requirement ~~therefrom~~to conduct additional pivotal Phase 3 clinical trial(s) and to complete other significant and time-consuming requirements related to clinical trials, or to conduct additional pre-clinical studies or manufacturing activities. If a Complete Response Letter is issued, the applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw the application or request an opportunity for a hearing. Even if such requested data and information are submitted, the FDA may decide that the BLA does not satisfy the criteria for approval.

InExpedited ~~light~~Development ~~of recent macroeconomic conditions~~ and ~~our~~Review strategic decisions, we have made, and will continue to make, judgments as to whether we should further reduce or otherwise change our workforce. For example, in the first quarter of 2024, we implemented the January Restructuring, a plan to reduce our workforce by approximately 35%, to align our workforce with our strategy to focus on our clinical stage, targeted oncology programs, IK-930 and IK-595. Furthermore, in the second quarter of 2024, we implemented the May Restructuring, a plan to discontinue the clinical development of IK-930, continue clinical development of IK-595, and reduce our workforce by approximately 53%. Such workforce reductions, and any other future reductions, and the attrition that may occur following them, may result in the loss of institutional knowledge and expertise and the reallocation and combination of certain roles and responsibilities across the organization, all of which could adversely affect our operations. Furthermore, the Restructurings, and other additional measures we might take to reduce costs, could strain our workforce, divert management attention, yield attrition beyond our intended reduction in force, reduce employee morale, cause us to delay, limit, reduce or eliminate certain development plans, or otherwise interfere with our ability to operate and grow our business effectively, each of which could have an adverse impact on our business, operating results, and financial condition. We may not complete current or any future restructuring activities on the anticipated timetable, and even if successfully completed, we may not achieve the anticipated cost savings, operating efficiencies, or other benefits of such activities.Programs

~~Risks~~A ~~Related~~sponsor may seek to develop and obtain approval of its product candidates under programs designed to accelerate the ~~Development~~development, FDA review and approval of ~~our~~product ~~Targeted~~candidates ~~Oncology~~that meet certain criteria. For example, the FDA has a Fast Track program that is intended to expedite or facilitate the process for reviewing new drugs and ~~Other~~biologics ~~Programs~~that are intended to treat a serious or life-threatening disease or condition and ~~Product~~demonstrate ~~Candidates~~the potential to address unmet medical needs for the condition. Fast Track designation applies to both the product and the specific indication for which it is being studied. For a Fast Track-designated biological product, the FDA may consider sections of the BLA for review on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the application, the FDA agrees to accept sections of the application and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application. The sponsor can request the FDA to designate the product for Fast Track status any time before receiving BLA approval, but ideally no later than the pre-BLA meeting.

IfA weproduct ~~continue~~submitted to ~~progress~~ the ~~development~~FDA for marketing authorization, including under a Fast Track program, may be eligible for other types of ~~our~~FDA programs intended to expedite development or review, such as priority review. Priority review means that, for an original BLA, the FDA sets a target date for FDA action on the marketing application at six months after accepting the application for filing as opposed to ten months. A product ~~candidates~~is eligible for priority review if it is designed to treat a serious or life-threatening disease condition and, weif ~~may~~approved, would provide a significant improvement in safety and effectiveness compared to available therapies. If criteria are not bemet ~~able~~for priority review, the application for an original BLA is subject to ~~successfully~~the ~~complete~~standard ~~clinical~~FDA ~~trials~~review period of ten months after FDA accepts the application for ~~our~~filing. ~~ongoing~~Priority ~~targeted~~review ~~oncology~~designation ~~program~~does not change the scientific/ medical standard for approval or ~~our~~the ~~current~~quality ~~product~~of ~~candidate~~evidence necessary to support approval.

~~To date~~Additionally, we have limited experience with completing clinical trials. We have not yet demonstrated our ability to successfully complete later-stage clinical trials, including large-scale, pivotal clinical trials, obtain regulatory approvals, manufacture a ~~commercial~~biologic ~~scale~~may ~~product,~~be oreligible ~~arrange~~ for adesignation ~~third~~as ~~party~~a tobreakthrough dotherapy soif onthe ~~our~~product ~~behalf,~~candidate oris ~~conduct sales and marketing activities necessary for successful commercialization. Before commencing certain clinical trials~~intended, wealone ~~may~~or ~~finalize~~in ~~the~~combination ~~trial design based on discussions~~ with ~~the~~one ~~FDA~~or ~~and~~more other ~~regulatory~~drugs ~~authorities. Any guidance we receive from the FDA~~ or ~~other regulatory authorities is subject to change. These regulatory authorities could change their positions~~biologics, ~~including, but not limited~~ to, ~~regarding~~treat ~~the~~a ~~acceptability~~serious ~~of our trial designs~~ or ~~the~~life-threatening ~~clinical~~condition ~~endpoints~~and ~~selected,~~preliminary ~~which may require us to complete additional~~ clinical ~~trials~~evidence orindicates ~~result~~that in the composition of stricter approval conditions than we currently expect. Successful completion of our clinical trials is a prerequisite to submitting an NDA to the FDA, the MAA, the EMA, or other marketing applications to regulatory authorities in other jurisdictions, for each product candidate ~~and,~~may ~~consequently,~~demonstrate ~~the~~substantial ~~regulatory approval of each product candidate.~~

If we continue to progress the development of our product candidates and are required to conduct additional preclinical studies or clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive, or are only modestly positive, or, if there are safety concerns, we may:

not obtain regulatory approval at all;

be delayed in obtaining regulatory approval for our product candidates;

obtain regulatory approval for indications or patient populations that are not as broad as intended or desired;

continue to be subject to post-marketing testing requirements; or

experience having the product removed from the market after obtaining regulatory approval.

~~Our~~Table ~~lead program is focused on the development~~ of oncology therapeutics for patients with genetically defined or biomarker-driven cancers, which is a rapidly evolving area of science, and the approach we have taken to discover and develop drugs is novel and may never lead to approved or marketable products. Contents

~~The~~improvement ~~discovery~~over ~~and~~currently ~~development~~approved oftherapies ~~oncology~~on ~~therapeutics~~one ~~for patients with genetically defined~~ or ~~biomarker-driven~~more ~~cancers~~clinically issignificant ~~an emerging field~~endpoints, ~~and~~such ~~the~~as ~~scientific~~substantial ~~discoveries~~treatment ~~that~~effects ~~form~~observed ~~the~~early ~~basis~~in ~~for~~clinical ~~our~~development. ~~efforts~~If tothe ~~discover~~FDA ~~and~~designates ~~develop~~a ~~product~~breakthrough ~~candidates~~therapy, ~~are~~it ~~relatively~~may ~~new.~~take ~~The~~actions ~~scientific~~appropriate ~~evidence~~ to ~~support~~expedite the ~~feasibility~~development and review of ~~developing~~the ~~product~~application, ~~candidates~~which ~~based~~may oninclude ~~these~~holding ~~discoveries~~meetings iswith ~~both~~the ~~preliminary~~sponsor and ~~limited.~~the ~~Although~~review weteam ~~believe,~~throughout ~~based~~the ondevelopment ~~our~~of ~~preclinical work, that~~ the ~~genetic~~therapy; ~~alterations~~providing ~~targeted~~timely byadvice ~~our~~to, ~~programs drive the formation~~ and ~~spread~~interactive ofcommunication ~~cancer~~with, ~~clinical~~the ~~results~~sponsor ~~may~~regarding ~~not~~the ~~confirm~~development ~~this~~of ~~hypothesis~~the orproduct ~~may~~candidate ~~only~~to ~~confirm~~ensure itthat ~~for~~the ~~certain~~development ~~alterations~~program orto ~~certain~~gather ~~tumor~~the ~~types.~~preclinical ~~The~~and ~~patient~~clinical ~~populations~~data necessary for ~~our~~approval ~~product~~is ~~candidates~~as ~~are~~efficient ~~limited~~as topracticable; ~~those~~assigning ~~with~~a ~~specific~~cross ~~target~~disciplinary ~~alterations~~project ~~and~~lead ~~may~~for ~~not~~the beFDA ~~completely~~review ~~defined~~team ~~but~~to ~~are~~facilitate ~~substantially~~an ~~smaller~~efficient ~~than~~review of the ~~general~~development ~~treated~~program ~~cancer population,~~ and ~~if we continue~~ to ~~progress~~serve ~~the~~as ~~development~~a ofscientific ~~our~~liaison ~~product~~between ~~candidates,~~the wereview ~~will~~team ~~need~~and tothe ~~screen~~sponsor; and ~~identify~~considering ~~these~~alternative ~~patients~~clinical ~~with~~trial ~~targeted~~designs ~~alterations.~~when ~~Successful~~scientifically ~~identification~~appropriate, ofwhich ~~patients~~may isresult ~~dependent~~in onsmaller ~~several~~trials ~~factors,~~or ~~including~~more ~~achieving~~efficient ~~certainty~~trials asthat torequire ~~how~~less ~~specific~~time ~~alterations respond~~ to ~~our~~complete ~~product~~and ~~candidates~~may ~~and~~minimize the ~~ability~~number toof ~~identify~~patients ~~such~~exposed ~~alterations.~~to ~~Furthermore,~~a ~~even~~potentially ifless weefficacious ~~are~~treatment. ~~successful~~Breakthrough intherapy ~~identifying~~designation ~~patients~~comes with ~~specific~~the ~~target~~benefits ~~alterations,~~of weFast ~~cannot~~Track bedesignation, ~~certain~~which means that the ~~resulting~~sponsor ~~patient~~may ~~populations~~file ~~for~~sections ~~each~~of ~~mutation~~the ~~will~~BLA befor ~~large~~review ~~enough~~on toa ~~allow~~rolling usbasis toif ~~successfully~~certain ~~obtain~~conditions ~~approval~~described ~~for~~above ~~each~~are ~~mutation type, commercialize our product candidates and achieve profitability~~satisfied.

~~Clinical~~Even if a product ~~development~~candidate ~~involves~~qualifies afor ~~lengthy~~one ~~and~~or ~~expensive~~more ~~process~~of these programs, ~~with~~the anFDA ~~uncertain~~may ~~outcome~~later decide that the product candidate no longer meets the conditions for qualification or the time period for FDA review or approval may not be shortened. Furthermore, Fast Track designation, priority review, and breakthrough therapy designation do not change the standards for approval.

~~Our~~Pediatric ~~ongoing~~Information ~~clinical trials,~~ and ~~future~~Pediatric clinical trials if we continue to progress the development of our product candidates, may not be successful. It is impossible to predict when, or if, any of our product candidates will prove effective and safe in humans or will receive regulatory approval. Before obtaining regulatory approval from regulatory authorities for the sale of any product candidate, we must complete preclinical studies and then conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and outcomes are uncertain. A failure of one or more clinical trials can occur at any stage of testing. The outcome of preclinical development testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain regulatory approval of their product candidates. Our future and ongoing clinical trials may not be successful. Exclusivity

IfUnder wethe ~~continue~~Pediatric Research Equity Act (“PREA”), certain BLAs and certain supplements to ~~progress~~a BLA must contain data to assess the ~~development~~safety and efficacy of ~~our~~the product ~~candidates~~candidate ~~and~~for ~~are~~the ~~unable~~claimed toindications ~~successfully~~in ~~validate,~~all ~~develop~~relevant pediatric subpopulations and ~~obtain~~to ~~regulatory~~support ~~approval~~dosing and administration for ~~companion~~each ~~diagnostic~~pediatric ~~tests~~subpopulation for ~~our~~which the product ~~candidates~~candidate is safe and effective. The FDA may grant deferrals for submission of pediatric data or full or partial waivers. A sponsor who is planning to submit a marketing application for a biologic that ~~require~~includes a new active ingredient, new indication, new dosage form, new dosing regimen or ~~would~~new ~~commercially~~route ~~benefit~~of ~~from~~administration must submit an initial Pediatric Study Plan (“PSP”), within 60 days of an end-of-Phase 2 meeting or, if there is no such ~~tests~~meeting, as early as practicable before the initiation of the Phase 3 or ~~experience~~Phase ~~significant~~2/3 ~~delays~~trial. inThe ~~doing~~initial soPSP must include an outline of the pediatric trial or studies that the sponsor plans to conduct, weincluding ~~may~~trial objectives and design, age groups, relevant endpoints and statistical approach, or a justification for not ~~realize~~including ~~the~~such detailed information, and any request for a deferral of pediatric assessments or a full ~~commercial~~or ~~potential~~partial waiver of ~~these~~the ~~product~~requirement ~~candidates~~to provide data from pediatric studies along with supporting information. The FDA and the sponsor must reach an agreement on the PSP. A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from pre-clinical studies, early phase clinical trials and other clinical development programs.

IfA webiologic ~~continue~~product tocan ~~progress~~also ~~the~~obtain ~~development~~pediatric ofmarket ~~our~~exclusivity ~~product candidates,~~ in ~~connection with~~ the ~~clinical~~United ~~development~~States. ofPediatric ~~our~~exclusivity, ~~product~~if ~~candidates for certain indications~~granted, weadds ~~may~~six ~~engage~~months ~~third parties~~ to ~~develop~~existing orexclusivity ~~otherwise~~periods ~~obtain access to in vitro companion diagnostic tests to identify patient subsets within a disease category who may derive selective~~ and ~~meaningful~~patent ~~benefit from our product candidates~~terms. ~~Such~~This ~~companion~~six-month ~~diagnostics~~exclusivity, ~~would~~which beruns ~~used~~from ~~during our clinical trials as well as in connection with~~ the ~~commercialization~~end of ~~our~~other ~~products~~exclusivity ~~that~~protection ~~receive regulatory approval. To be successful, we~~ or ~~our~~patent ~~collaborators will need to address a number of scientific~~term, ~~technical,~~may ~~regulatory,~~be ~~and~~granted ~~logistical~~based ~~challenges.~~on ~~The FDA and comparable foreign regulatory authorities regulate in vitro companion diagnostics as medical devices and, under that regulatory framework, will likely require~~ the ~~conduct~~voluntary ofcompletion ~~clinical trials to demonstrate the safety and effectiveness~~ of ~~any~~a ~~diagnostics~~pediatric westudy ~~may~~in ~~develop,~~accordance ~~which~~with wean ~~expect~~FDA-issued ~~will~~“Written ~~require~~Request” ~~separate~~for ~~regulatory~~such ~~clearance~~a ~~or approval prior to commercialization~~study.

IfPost-Marketing we continue to progress the development of our product candidates, we intend to rely on third parties for the design, development, and manufacture of companion diagnostic tests for our therapeutic product candidates that may require such tests. If we enter into such collaborative agreements, we will be dependent on the sustained cooperation and effort of our future collaborators in developing and obtaining approval for these companion diagnostics. It may be necessary to resolve issues such as selectivity/specificity, analytical validation, reproducibility, or clinical validation of companion diagnostics during the development and regulatory approval processes. Moreover, even if data from preclinical studies and early clinical trials appear to support development of a companion diagnostic for a product candidate, data generated in later clinical trials may fail to support the analytical and clinical validation of the companion diagnostic. We and our future collaborators may encounter difficulties in developing, obtaining regulatory approval for, manufacturing and commercializing companion diagnostics similar to those we face with respect to our therapeutic product candidates themselves, including issues with achieving regulatory clearance or approval, production of sufficient quantities at commercial scale and with appropriate quality standards, and in gaining market acceptance. If we are unable to successfully develop companion diagnostics for these therapeutic product candidates, or experience delays in doing so, the development of these therapeutic product candidates may be adversely affected, these therapeutic product candidates may not obtain Requirements

Following approval of a new product, the manufacturer and the approved product are subject to continuing regulation by the FDA, including, among other things, monitoring and record-keeping activities, reporting of adverse experiences, complying with promotion and advertising requirements, which include restrictions on promoting products for unapproved uses or patient populations (known as “off-label use”) and limitations on industry sponsored scientific and educational activities. Although physicians may prescribe legally available products for off-label uses, manufacturers may not market or promote such uses. The FDA and other agencies 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 liability, including investigation by federal and state authorities. Prescription drug promotional materials must be submitted to the FDA in conjunction with their first use or first publication. Further, if there are any modifications to the product, including changes in indications, labeling or manufacturing processes or facilities, the applicant may be required to submit and obtain FDA approval of a new BLA or BLA supplement, which may require the development of additional data or pre-clinical studies and clinical trials.

~~regulatory~~Table ~~approval, and we may not realize the full commercial potential~~ of any of these therapeutic products that obtain regulatory approval. As a result, our business, results of operations and financial condition could be materially harmed. In addition, a diagnostic company with whom we contract may decide to discontinue selling or manufacturing the companion diagnostic test that we anticipate using in connection with development and commercialization of our product candidates or our relationship with such diagnostic company may otherwise terminate. We may not be able to enter into arrangements with another diagnostic company to obtain supplies of an alternative diagnostic test for use in connection with the development and commercialization of our product candidates or do so on commercially reasonable terms, which could adversely affect and/or delay the development or commercialization of our therapeutic product candidates. Contents

~~Interim~~The FDA may also place other conditions on approvals including the requirement for a risk evaluation and mitigation strategy (“REMS”), ~~top-line~~to assure the safe use of the product. If the FDA concludes a REMS is needed, the FDA will not approve the BLA without the sponsor’s submission of a proposed REMS, and ~~preliminary~~FDA ~~data~~approval ~~from~~thereof. ~~our~~REMS ~~clinical~~could ~~trials~~include ~~that~~medication weguides, ~~announce~~physician orcommunication ~~publish~~plans ~~from~~or ~~time~~elements to ~~time~~assure ~~may~~safe ~~change~~use, such as ~~more~~restricted ~~patient~~distribution ~~data~~methods, ~~become~~patient ~~available~~registries and ~~are~~other ~~subject~~risk tominimization ~~confirmation,~~tools. ~~audit~~Any ~~and~~of ~~verification~~these ~~procedures~~limitations ~~that~~on approval or marketing could ~~result~~restrict inthe ~~material~~commercial ~~changes~~promotion, indistribution, ~~the~~prescription ~~final~~or ~~data~~dispensing of products. Product approvals may be withdrawn for non-compliance with regulatory standards or if problems occur following initial marketing.

~~From~~FDA ~~time~~regulations torequire ~~time,~~that weproducts ~~may~~be ~~publicly~~manufactured ~~disclose~~in ~~interim,~~specific ~~top-line,~~approved orfacilities ~~preliminary~~and ~~data~~in ~~from~~accordance ~~our~~with ~~clinical~~cGMP ~~trials,~~regulations. ~~which~~We isrely, ~~based~~and onexpect ato ~~preliminary~~continue ~~analysis~~to ofrely, ~~then-available~~on ~~data,~~third ~~and~~parties for the ~~results~~production ~~and~~of ~~related~~clinical ~~findings~~ and ~~conclusions~~commercial ~~are~~quantities ~~subject~~of toour ~~change~~products ~~following~~in aaccordance ~~more~~with ~~comprehensive~~cGMP ~~review~~regulations. ofThese ~~the~~manufacturers ~~data.~~must Wecomply ~~also~~with ~~make~~cGMP ~~assumptions,~~regulations ~~estimations~~that require, ~~calculations~~among other things, ~~and~~quality ~~conclusions~~control asand ~~part~~quality ofassurance, ~~our~~the ~~analyses~~maintenance of ~~data,~~records and wedocumentation ~~may~~and ~~not~~the ~~have~~obligation ~~received~~to ~~all~~investigate ofand ~~the~~correct ~~necessary~~any ~~data~~deviations orfrom ~~had~~cGMP. ~~the~~Manufacturers ~~opportunity~~and toother ~~fully~~entities ~~and~~involved ~~carefully~~in ~~evaluate~~the ~~all~~manufacture ~~data.~~and Asdistribution aof ~~result,~~approved ~~the~~biologics ~~interim,~~are ~~top-line~~required orto ~~preliminary~~register ~~results~~their ~~that~~establishments wewith ~~report~~the ~~may~~FDA ~~differ~~and ~~from~~certain ~~future~~state ~~results~~agencies, ofand ~~the~~are ~~same~~subject ~~trials,~~to orperiodic ~~different~~unannounced ~~conclusions~~inspections orby ~~considerations~~the ~~may~~FDA ~~qualify~~and ~~such~~certain ~~results,~~state ~~once~~agencies ~~additional~~for ~~data~~compliance ~~have~~with ~~been~~cGMP ~~received~~requirements and ~~fully~~other ~~evaluated~~laws. ~~Interim~~Manufacturers ~~data~~and ~~from~~other ~~clinical~~parties ~~trials~~involved ~~are~~in ~~subject to~~ the ~~risk~~drug ~~that~~supply ~~one~~chain orfor ~~more~~prescription ofdrug ~~the~~products ~~clinical~~must ~~outcomes~~also ~~may~~comply ~~materially~~with ~~change~~product astracking ~~patient~~and ~~enrollment~~tracing ~~continues~~requirements and ~~more~~for ~~patient~~notifying ~~data~~the ~~become~~FDA ~~available.~~of ~~Preliminary~~counterfeit, ~~interim~~diverted, orstolen ~~top-line~~and ~~data~~intentionally ~~also~~adulterated ~~remain~~products ~~subject~~or toproducts ~~audit~~that ~~and~~are ~~verification~~otherwise ~~procedures~~unfit ~~that~~for ~~may~~distribution ~~result~~ in the ~~final~~United ~~data~~States. ~~being~~Accordingly, ~~materially~~manufacturers ~~different~~must ~~from~~continue ~~the~~to ~~preliminary~~expend ~~top-line~~time, ~~data~~money weand ~~previously~~effort ~~published.~~in Asthe aarea ~~result,~~of ~~preliminary,~~production ~~interim,~~ and ~~top-line~~quality ~~data~~control ~~should~~to bemaintain ~~viewed~~cGMP ~~with~~compliance. ~~caution~~The ~~until~~discovery ~~the~~of ~~final~~violative ~~data~~conditions, ~~are~~including ~~available.~~failure ~~Adverse~~to ~~differences~~conform ~~between~~to ~~preliminary~~cGMP orregulations, ~~interim~~could ~~data~~result in enforcement actions, and ~~final~~the ~~data~~discovery ~~could~~of ~~significantly~~problems ~~harm~~with ~~our~~a ~~business~~product ~~prospects~~after ~~and~~approval may ~~cause~~result ~~the~~in ~~price~~restrictions ofon ~~our~~a ~~common~~product, ~~stock~~manufacturer toor ~~fluctuate~~holder orof ~~decline.~~an approved BLA, including recall.

~~Further,~~Once ~~regulatory~~an ~~agencies~~approval ~~and~~is ~~others~~granted, the FDA may ~~not~~issue ~~accept~~enforcement letters or ~~agree~~revoke the approval of the product if compliance with ~~our~~regulatory ~~assumptions,~~requirements ~~estimates,~~and ~~calculations,~~standards ~~conclusions,~~is ornot ~~analyses,~~maintained or ~~may~~if ~~interpret~~problems oroccur ~~weigh~~after the ~~importance~~product ofreaches ~~data~~the ~~differently,~~market. ~~which~~Corrective action could ~~adversely~~delay ~~impact~~product ~~the~~distribution ~~potential~~and ofrequire ~~the~~significant ~~particular~~time ~~program,~~and ~~the~~financial ~~likelihood~~expenditures. ofLater ~~obtaining~~discovery ~~regulatory~~of ~~approval~~previously ofunknown ~~the~~problems ~~particular~~with ~~product~~a ~~candidate~~product, ~~commercialization~~including adverse events of ~~any~~unanticipated ~~approved~~severity ~~product~~or ~~and~~frequency, ~~the~~or ~~business~~with ~~prospects~~manufacturing ofprocesses, ~~our~~or ~~company~~failure into ~~general.~~comply Inwith ~~addition~~regulatory requirements, ~~the~~may ~~information~~result wein ~~choose~~revisions to ~~publicly~~the ~~disclose~~approved ~~regarding~~labeling ato ~~particular~~add ~~study~~new orsafety ~~clinical~~information; ~~trial~~imposition isof ~~derived~~post-market ~~from~~studies ~~information~~or ~~that~~clinical istrials ~~typically~~to ~~extensive,~~assess ~~and~~new ~~you~~safety risks; or ~~others~~imposition ~~may~~of ~~not~~distribution ~~agree~~or ~~with~~other ~~what~~restrictions weunder ~~determine~~a isREMS ~~material~~program. orOther ~~otherwise~~potential ~~appropriate~~consequences ~~information to~~ include, inamong ~~our disclosure.~~ others:

•

Ifrestrictions on the ~~preliminary,~~marketing ~~interim,~~ or ~~top-line~~manufacturing ~~data~~of ~~that~~the ~~we report differ from actual results~~product, orcomplete ifwithdrawal ~~regulatory~~of ~~authorities or others, disagree with~~ the ~~conclusions reached, our ability to obtain approval for, and commercialize, our~~ product ~~candidates~~from ~~may~~the bemarket ~~significantly impaired, which could materially harm our business, operating results, prospects,~~ or ~~financial~~product ~~condition.~~ recalls;

•

~~If we continue to progress the development of our product candidates~~fines, wewarning ~~may incur additional costs or experience delays in initiating or completing~~letters, or ~~ultimately~~untitled ~~be unable to complete, development and commercialization.~~letters;

•

~~We may experience delays in initiating or completing~~ clinical ~~trials,~~holds ~~including~~(partial ~~as a result of delays in obtaining,~~ or ~~failure~~full) to obtain, the FDA’s clearance to initiate clinical trials under future INDs. Additionally, if we continue to progress the development of our product candidates, we cannot be certain that nonclinical studies or clinical trials for our product candidates will not be delayed, require redesign, will enroll an adequate number of subjects on ~~time, or will be completed on schedule, if at all. We may experience numerous unforeseen events during, or as a result of, nonclinical studies and~~ clinical trials ~~that could delay or prevent our ability to receive regulatory approval or commercialize our product candidates if development continues to progress, including:~~ ;

•

werefusal ~~may~~of ~~receive~~the ~~feedback~~FDA ~~from regulatory authorities that require us~~ to ~~modify~~approve ~~the~~pending ~~design~~applications or ~~implementation~~supplements ofto ~~our~~approved ~~nonclinical~~applications, ~~studies~~ or ~~clinical~~suspension ~~trials~~ or torevocation ~~delay~~of orproduct ~~terminate a clinical trial~~approvals;

•

~~regulators,~~product ~~IRBs~~seizure or ~~ethics~~detention, ~~committees may delay~~ or ~~may~~refusal ~~not authorize us or our investigators~~ to ~~commence~~permit athe ~~clinical~~import ~~trial~~ or ~~conduct~~export aof ~~clinical trial at a prospective trial site~~products;

•

weconsent ~~may experience delays in reaching~~decrees, orcorporate ~~fail~~integrity ~~to reach~~agreements, ~~agreement~~debarment onor ~~acceptable~~exclusion ~~terms~~from ~~with~~federal ~~prospective~~healthcare ~~trial sites and prospective CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites~~programs;

•

~~nonclinical~~mandated ~~studies~~modification ~~or clinical trials~~ of ~~our~~promotional ~~product~~materials ~~candidates~~and ~~may~~labeling ~~fail to show safety or efficacy or otherwise produce negative or inconclusive results,~~ and wethe ~~may~~issuance ~~decide,~~of orcorrective ~~regulators may require us, to conduct additional preclinical studies or clinical trials, or we may decide to abandon product development programs~~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.

Biosimilars and Exclusivity

An abbreviated approval pathway for biological products shown to be similar to, or interchangeable with, an FDA-licensed reference biological product was created by the Biologics Price Competition and Innovation Act of 2009. This amendment to the PHSA, in part, attempts to minimize duplicative testing. Biosimilarity, which requires that the

~~nonclinical~~Table ~~studies or clinical trials~~ of ~~our product candidates may not produce differentiated or clinically significant results across tumor types or indications;~~ Contents

biological product be highly similar to the ~~number~~reference product notwithstanding minor differences in clinically inactive components and that there be no clinically meaningful differences between the product and the reference product in terms of ~~patients~~safety, ~~required~~purity ~~for~~and potency, can be shown through analytical studies, animal studies and a clinical trial or trials. ofInterchangeability ~~our~~requires that a biological product ~~candidates~~be ~~may~~biosimilar to the reference product and that the product can be ~~larger~~expected ~~than~~to weproduce ~~anticipate,~~the ~~enrollment~~same clinical results as the reference product in ~~these~~any ~~clinical~~given ~~trials~~patient and, for products administered multiple times to an individual, that the product and the reference product may be ~~slower~~alternated ~~than~~or weswitched ~~anticipate~~after orone ~~participants~~has ~~may~~been ~~drop~~previously ~~out~~administered ofwithout ~~these~~increasing ~~clinical~~safety ~~trials~~risks or ~~fail~~risks of diminished efficacy relative to ~~return~~exclusive ~~for~~use ~~post-treatment~~of ~~follow-up~~the atreference abiological ~~higher~~product ~~rate~~without ~~than~~such wealternation ~~anticipate;~~or switch.

~~our~~The ~~third~~FDA ~~party~~will ~~contractors~~not ~~may~~accept ~~fail~~an toapplication ~~comply~~for ~~with~~a ~~regulatory~~biosimilar ~~requirements,~~or ~~fail~~interchangeable toproduct ~~maintain~~based ~~adequate~~on ~~quality~~the ~~controls~~reference biological product until four years after the date of first licensure of the reference product, beand ~~unable~~the toFDA ~~provide~~will usnot ~~with~~approve ~~sufficient~~an application for a biosimilar or interchangeable product ~~supply~~based toon ~~conduct~~the reference biological product until 12 years after the date of first licensure of the reference product. “First licensure” typically means the initial date the particular product at issue was licensed in the United States. Date of first licensure does not include the date of licensure of (and a new period of exclusivity is not available for) a biological product if the licensure is for a supplement for the biological product or ~~complete~~for ~~nonclinical~~a ~~studies~~subsequent application by the same sponsor or ~~clinical~~manufacturer ~~trials~~of the biological product (or licensor, ~~fail~~predecessor toin ~~meet~~interest, ~~their~~or ~~contractual~~other ~~obligations~~related entity) for a change (not including a modification to usthe structure of the biological product) that results in a ~~timely~~new ~~manner~~indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or atstrength, ~~all~~or for a modification to the structure of the biological product that does not result in a change in safety, purity, or ~~may~~potency. ~~deviate~~Therefore, ~~from~~one must determine whether a new product includes a modification to the ~~clinical~~structure ~~trial~~of ~~protocol~~a previously licensed product that results in a change in safety, purity, or ~~drop~~potency ~~out~~to assess whether the licensure of the ~~trial,~~new ~~which~~product ~~may~~is ~~require~~a first licensure that wetriggers ~~add~~its ~~new~~own ~~clinical~~period ~~trial~~of ~~sites~~exclusivity. orWhether ~~investigators;~~a subsequent application, if approved, warrants exclusivity as the “first licensure” of a biological product is determined on a case-by-case basis with data submitted by the sponsor.

weOther ~~may~~United ~~elect~~States ~~to,~~Healthcare or regulators or IRBs or ethics committees may require us or our investigators to, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants in our clinical trials are being exposed to unacceptable health risks; Laws

Healthcare providers and third-party payors in the ~~cost~~United ofStates ~~clinical~~and ~~trials~~elsewhere play a primary role in the recommendation and prescription of ~~our~~pharmaceutical ~~product~~products. ~~candidates~~Arrangements ~~may~~with bethird-party ~~greater~~payors ~~than~~and wecustomers ~~anticipate;~~can expose pharmaceutical supply to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation:

•

The federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the ~~supply~~referral of an individual, or ~~quality~~the purchase, lease, order or recommendation of ~~our~~any ~~product~~good, ~~candidates~~facility, item or service for which payment may be made, in whole or in part, under the Medicare and Medicaid programs, or other ~~materials~~federal ~~necessary~~healthcare toprograms. ~~conduct~~A ~~clinical~~person ~~trials~~or entity can be found guilty of ~~our~~violating ~~product~~the ~~candidates~~statute without actual knowledge of the statute or specific intent to violate it. In addition, the government may beassert ~~insufficient~~that a claim including items or ~~inadequate;~~services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act (“FCA”). The Anti- Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, but such exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection;

•

~~our~~The ~~product~~federal ~~candidates~~civil ~~may~~and ~~have~~criminal ~~undesirable~~false ~~side~~claims ~~effects~~laws, including the FCA, and civil monetary penalty laws, which prohibit any person or entity from, among other ~~unexpected~~things, ~~characteristics~~knowingly presenting, or causing usto be presented, a false, fictitious or ~~our~~fraudulent ~~investigators~~claim for payment to, ~~regulators~~or approval by, the federal government or ~~IRBs~~knowingly making, using or ~~ethics~~causing ~~committees~~to be made or used a false record or statement, including providing inaccurate billing or coding information to ~~suspend~~customers or ~~terminate~~promoting ~~the~~a ~~trials~~product off-label, material to a false or ~~reports~~fraudulent ~~may~~claim ~~arise~~to ~~from~~the ~~nonclinical~~federal government. A claim includes “any request or ~~clinical~~demand” ~~testing~~for ofmoney ~~other~~or ~~cancer~~property ~~therapies~~presented ~~that~~to ~~raise~~the ~~safety~~federal government. In addition, manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or ~~efficacy~~fraudulent ~~concerns~~claims. ~~about~~The ~~our~~FCA ~~product~~also ~~candidates;~~permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery;

regulators may revise the requirements for approving our product candidates, or such requirements may not be as we currently anticipate.

We could encounter delays if a clinical trial is suspended or terminated by us, including upon the recommendation of the Safety Monitoring Committee (“SMC”) if applicable for such trial, by the IRBs of the institutions at which such trials are being conducted, or by the FDA or other regulatory authorities. Such authorities may impose such a suspension or termination or clinical hold due to a number of factors, including, but not limited to, failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, adverse findings upon an inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. Many 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. Further, the FDA may disagree with, among other considerations, our clinical trial design or our interpretation of data from clinical trials or may change the requirements for approval even after it has reviewed and commented on the design for our clinical trials.

Moreover, principal investigators for our current and future clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected the interpretation of the study. The FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site, and the utility of the clinical trial itself may be jeopardized. Such an outcome could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of regulatory approval of one or more of our product candidates.

Our product development costs will also increase if we continue to progress development and experience delays in testing or regulatory approvals. We do not know whether any of our future clinical trials will begin as planned, or whether any of our current or future clinical trials will need to be restructured or will be completed on schedule, if at all. Significant preclinical study or clinical trial delays could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do, which would impair our ability to successfully commercialize our product candidates and may significantly harm our business, operating results, financial condition and prospects.

IfTable ~~we continue to progress the development~~ of ~~our product candidates and experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.~~Contents

•

Ifthe weHealth ~~continue~~Insurance toPortability ~~progress~~and ~~the~~Accountability ~~development~~Act of(“HIPAA”), ~~our~~which ~~product~~created ~~candidates~~federal criminal statutes that prohibit, weamong ~~may~~other ~~not~~things, beknowingly ~~able~~and towillfully ~~initiate~~executing, or ~~continue~~attempting ~~clinical~~to ~~trials~~execute, ~~for~~a ~~our~~scheme ~~product~~to ~~candidates~~defraud ifany wehealthcare ~~are~~benefit ~~unable~~program toor ~~locate~~obtain, ~~and~~by ~~enroll~~means aof ~~sufficient~~false ~~number~~or offraudulent ~~eligible~~pretenses, ~~patients~~representations, toor ~~participate~~promises, inany ~~these~~of ~~trials~~the asmoney ~~required~~or property owned by, or under the ~~FDA~~custody or ~~comparable~~control ~~foreign~~of, ~~regulatory~~any ~~authorities~~healthcare benefit program, regardless of the payor (e.g., public or asprivate) ~~needed~~and toknowingly ~~provide~~and ~~appropriate~~willfully ~~statistical~~falsifying, ~~power~~concealing ~~for~~or covering up by any trick or device a ~~given~~material ~~trial.~~fact ~~For~~or ~~example,~~making ~~because~~any wematerially ~~are~~false ~~focused~~statements onin ~~patients~~connection with ~~specific~~the ~~genetic~~delivery ~~mutations~~of, or ~~biomarkers~~payment for, ~~the~~healthcare ~~development~~benefits, ofitems ~~our~~or ~~targeted~~services ~~oncology~~relating ~~program,~~to ~~our~~healthcare ~~ability~~matters. Similar to ~~enroll~~the ~~eligible~~federal ~~patients~~Anti-Kickback ~~may~~Statute, bea ~~limited~~person or ~~may~~entity ~~result~~can inbe ~~slower~~found ~~enrollment~~guilty ~~than~~of weviolating ~~anticipate.~~HIPAA without actual knowledge of the statute or specific intent to violate it;

•

WeHIPAA, ~~may~~as ~~experience~~amended ~~difficulties~~by ~~with~~the ~~identifying~~Health ~~specific~~Information ~~patient~~Technology ~~populations~~ for ~~any~~Economic ~~biomarker-defined~~and ~~trial~~Clinical ~~cohorts.~~Health ~~The~~Act ~~patient~~(“HITECH”), ~~eligibility~~and ~~criteria~~their ~~defined~~respective inimplementing ~~our~~regulations, ~~trial~~which ~~protocols~~impose, ~~including~~among ~~biomarker-driven~~other ~~identification~~things, ~~may~~specified ~~limit~~requirements relating to the ~~patient~~privacy, ~~populations~~security ~~eligible~~and ~~for~~transmission ~~our~~of ~~clinical~~individually ~~trials~~identifiable tohealth ainformation ~~greater~~held ~~extent~~by ~~than~~covered ~~competing~~entities ~~clinical~~and ~~trials~~their ~~for~~business ~~the~~associates ~~same~~as ~~indication~~well ~~that~~as dotheir ~~not~~covered ~~have~~subcontractors. ~~biomarker-driven~~HITECH ~~patient~~also ~~eligibility~~created ~~criteria.~~new Wetiers ~~will~~of ~~also~~civil ~~rely~~monetary onpenalties, ~~the~~amended ~~willingness~~HIPAA to make civil and ~~ability~~criminal ofpenalties ~~clinicians~~directly applicable to ~~screen~~business ~~their~~associates, ~~patients~~and ~~for~~gave ~~biomarkers~~state toattorneys ~~indicate~~general ~~which~~new ~~patients~~authority ~~may~~to befile ~~eligible~~civil actions for ~~enrollment~~damages or injunctions in ~~our~~federal ~~clinical~~courts ~~trials.~~to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions;

•

InThe ~~addition~~federal legislation commonly referred to as the Physician Payments Sunshine Act, ~~some~~created under the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “ACA”), and its implementing regulations, which requires certain manufacturers of ~~our~~drugs, ~~competitors~~devices, ~~have~~biologics ~~ongoing~~and ~~clinical~~medical ~~trials~~supplies for ~~product~~which ~~candidates~~payment ~~that~~is ~~treat~~available under Medicare, Medicaid or the ~~same~~Children’s ~~indications~~Health asInsurance doProgram ~~our~~(with ~~product~~certain ~~candidates~~exceptions) to report annually to the Centers for Medicare & Medicaid Services (“CMS”), information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists, and ~~patients~~chiropractors) ~~who~~and ~~would~~certain ~~otherwise~~other bepractitioners, ~~eligible~~including ~~for~~physician ~~our~~assistants, nurse practitioners, clinical ~~trials~~nurse ~~may~~specialists, ~~instead~~certified ~~enroll~~nurse inanesthetists, ~~clinical~~and ~~trials~~certified ofnurse ~~our~~midwives, ~~competitors’~~and ~~product~~teaching ~~candidates.~~hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

•

InFederal ~~addition~~government toprice ~~the~~reporting ~~competitive trial environment~~laws, ~~the~~which ~~eligibility criteria of our ongoing clinical trials will further limit the pool of available study participants as we will~~ require ~~that~~us ~~patients have specific characteristics that we can measure~~ to ~~assure~~calculate ~~their~~and ~~cancer~~report iscomplex ~~either~~pricing ~~severe~~metrics ~~enough or not too advanced to include them~~ in aan ~~study.~~accurate Additionally, the process of finding patients may prove costly. We also may not be able to identify, recruit, or enroll a sufficient number of patients to complete our clinical studies because of the perceived risks and ~~benefits~~timely ofmanner the product candidates under study, the availability and efficacy of competing therapies and clinical trials, the proximity and availability of clinical trial sites for prospective patients, and the patient referral practices of physicians. If patients are unwilling to ~~participate~~government ~~in our studies for any reason, the timeline for recruiting patients, conducting studies, and obtaining regulatory approval of potential products may be delayed.~~ programs;

•

WeAnalogous ~~may~~state ~~also~~laws ~~engage~~and ~~third~~regulations, ~~parties~~including: tostate ~~develop~~anti-kickback ~~companion~~and ~~diagnostics~~false ~~for~~claims ~~use~~laws, inwhich may apply to our ~~clinical~~business ~~trials~~practices, including, but ~~such~~not ~~third~~limited ~~parties~~to, ~~may~~research, ~~not~~distribution, besales ~~successful~~and inmarketing ~~developing~~arrangements ~~such~~and ~~companion~~claims ~~diagnostics~~involving healthcare items or services reimbursed by any third-party payor, ~~limiting~~including ~~our~~private ~~ability~~insurers; tostate ~~identify~~laws ~~patients~~that require pharmaceutical companies to comply with the ~~targeted~~pharmaceutical ~~genetic~~industry’s ~~mutations~~voluntary ~~for~~compliance ~~our~~guidelines ~~clinical~~and ~~trials~~the relevant compliance guidance promulgated by the U.S. ~~Further~~federal government, ifor weotherwise ~~are~~restrict ~~required~~payments that may be made to ~~develop~~healthcare ~~companion~~providers ~~diagnostics~~and other potential referral sources; state and ~~are~~local ~~unable~~laws tothat ~~include~~require ~~patients~~drug ~~with~~manufacturers ~~the~~to ~~targeted~~report ~~genetic~~information ~~mutations,~~related ~~this~~to ~~could~~payments ~~compromise~~and ~~our~~other ~~ability~~transfers of value to ~~seek~~physicians ~~participation~~and inother healthcare providers or marketing expenditures; state laws that require the ~~FDA’s~~reporting ~~expedited~~of ~~review~~information related to drug pricing; state and ~~development~~local ~~programs,~~laws ~~including~~requiring ~~breakthrough~~the ~~therapy~~registration ~~designation~~of pharmaceutical sales representatives; and ~~fast~~state ~~track~~laws ~~designation,~~governing orthe ~~otherwise~~privacy ~~seek~~and tosecurity ~~accelerate~~of ~~clinical~~health ~~development~~information ~~and~~in ~~regulatory~~some ~~timelines.~~circumstances, ~~Patient~~many ~~enrollment~~of ~~may~~which bediffer ~~affected~~from byeach other ~~factors~~in significant ways and often are not preempted by HIPAA, ~~including:~~thus complicating compliance efforts; and

•

~~the~~The ~~severity~~distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the ~~disease~~unauthorized ~~under~~sale ~~investigation;~~of pharmaceutical products.

The failure to comply with any of these laws or regulatory requirements subjects companies to possible legal or regulatory action. Depending on the ~~efforts~~circumstances, failure to ~~obtain~~meet ~~and~~applicable ~~maintain~~regulatory ~~patient~~requirements ~~consents~~can result in significant penalties, including civil, criminal and ~~facilitate~~administrative ~~timely~~penalties, ~~enrollment~~damages, fines, disgorgement, imprisonment, possible exclusion from participation in ~~clinical~~federal ~~trials;~~and state funded healthcare programs, contractual damages and the curtailment or restricting of our operations, as well as additional reporting obligations and oversight if a company becomes subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Any action for violation of these laws, even if successfully defended, could cause a pharmaceutical company to incur significant legal expenses and divert management’s attention from the operation of the business.

the ability to monitor patients adequately during and after treatment;

the risk that patients enrolled in clinical trials will drop out of the clinical trials before clinical trial completion;

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

reporting of the preliminary results of any of our clinical trials; and

factors we may not be able to control that may limit patients, principal investigators or staff or clinical site availability.

If we continue to progress the development of our product candidates, we anticipate that certain product candidates will be used in combination with third-party drugs or biologics, some of which are still in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such drugs or biologics.

If we continue to progress the development of our product candidates, certain product candidates have the potential to be administered in combination with other targeted therapies or checkpoint inhibitor immunotherapies, and other standards of care, like chemotherapies, or radiotherapy. Our ability to develop and ultimately commercialize product candidates used in combination with osimertinib, or checkpoint inhibitor immunotherapies or other targeted therapies, will depend on our ability to access such drugs or biologics on commercially reasonable terms for the clinical trials and their availability for use with our commercialized product, if approved. We cannot be certain that current or potential future commercial relationships will provide us with a steady supply of such drugs or biologics on commercially reasonable terms or at all.

~~Any~~Table ~~failure to maintain or enter into new successful commercial relationships, or the expense~~ of purchasing targeted therapies checkpoint inhibitor immunotherapies or other comparator therapies in the market, may delay our development timelines, increase our costs and jeopardize our ability to develop our current product candidates and any future product candidates as commercially viable therapies. If any of these occur, our business, financial condition, operating results, stock price and prospects may be materially harmed. Contents

~~Moreover,~~Health the development of product candidates for use in combination with another product or product candidate may present challenges that are not faced for single agent product candidates. The FDA, other U.S. regulatory agencies and/or comparable foreign regulatory authorities may require us to use more complex clinical trial designs in order to evaluate the contribution of each product and product candidate to any observed effects. It is possible that the results of such trials could show that any positive previous trial results are attributable to the combination therapy and not our current product candidates and any future product candidates. Moreover, following product approval, the FDA, other U.S. regulatory agencies and/or comparable foreign regulatory authorities may require that products used in conjunction with each other be cross labeled for combined use. To the extent that we do not have rights to the other product, this may require us to work with a third party to satisfy such a requirement. Moreover, developments related to the other product may impact our clinical trials for the combination as well as our commercial prospects should we receive regulatory approval. Such developments may include changes to the other product’s safety or efficacy profile, changes to the availability of the other product, quality, manufacturing and supply issues with respect to the other product, and changes to the standard of care. Reform

In the ~~event~~United ~~that~~States, ~~any~~there ~~future~~have ~~collaborator~~been orand ~~supplier~~continue ~~cannot~~to ~~continue~~be a number of legislative initiatives to ~~supply~~contain ~~their~~healthcare ~~products~~costs. onFor ~~commercially~~example, ~~reasonable~~in ~~terms~~March 2010, wethe ~~would~~ACA ~~need~~was topassed, ~~identify~~which ~~alternatives~~substantially ~~for~~changed ~~accessing~~the ~~targeted~~way ~~therapies~~healthcare is financed by both governmental and private insurers, ~~checkpoint~~and ~~inhibitor~~continues ~~immunotherapies~~to orsignificantly ~~other~~impact ~~combination~~the ~~agents~~U.S. ~~Additionally~~pharmaceutical industry. Since its enactment, ~~should~~there have been judicial, congressional and executive challenges to the ~~supply~~ACA. In addition, there have been a number of ~~products~~health ~~from~~reform ~~any~~initiatives ~~current~~that orhave ~~future~~impacted ~~collaborator~~the orACA. ~~supplier~~For beexample, ~~interrupted~~on July 4, ~~delayed~~2025, orthe ~~otherwise~~One beBig ~~unavailable~~Beautiful toBill usAct, ~~our~~was ~~clinical~~signed ~~trials~~into ~~may~~law be(“OBBBA”), ~~delayed.~~which Innarrowed ~~the~~access ~~event~~to weACA ~~are~~marketplace ~~unable~~exchange enrollment and declined to ~~source~~extend anthe ~~alternative~~ACA ~~supply~~enhanced advanced premium tax credits that expired at the end of 2025, orwhich, among other provisions in the law, are ~~unable~~anticipated to doreduce sothe onnumber ~~commercially~~of ~~reasonable~~Americans ~~terms,~~with ~~our~~health ~~business,~~insurance. The ~~financial~~OBBBA ~~condition~~also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, ~~operating~~capping ~~results~~state-directed payments, ~~stock~~reducing ~~price~~federal funding, and ~~prospects~~limiting ~~may~~provider betaxes ~~materially~~used ~~harmed~~to fund the program. Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies. It is unclear how the healthcare reform initiatives of the current administration or other efforts, if any, to challenge, repeal or replace the ACA will impact the pharmaceutical industry and our business.

~~Results~~The ~~from~~current ~~early~~administration ~~preclinical~~is ~~studies~~pursuing policies to reduce regulations and ~~clinical~~expenditures ~~trials~~across government including at the U.S. Department of ~~our~~Health ~~programs~~and Human Services (“HHS”), the FDA, CMS and ~~product~~related ~~candidates~~agencies. ~~are~~For ~~not~~example, ~~necessarily~~the ~~predictive~~current ofadministration announced agreements with several pharmaceutical companies that require the ~~results~~drug ofmanufacturers ~~later~~to ~~preclinical~~offer, ~~studies~~through ~~and~~a ~~clinical~~direct-to-consumer ~~trials~~platform, ofU.S. ~~our~~patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and ~~product~~repatriation ~~candidates~~of foreign revenues. IfOther werecent ~~continue~~actions, topresently ~~progress~~directed by executive orders or memoranda from the ~~development~~Office of Management and Budget, may propose policy changes that create additional uncertainty for our ~~product~~business. ~~candidates~~These actions and ~~cannot~~proposals ~~replicate~~may, for example, include directives: (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 ~~results~~Medicare ~~from~~Drug ~~our~~Price ~~earlier~~Negotiation ~~preclinical~~Program ~~studies~~and establishing Most-Favored-Nation pricing for pharmaceutical products; (3) imposing tariffs on imported pharmaceutical products; and ~~clinical~~(4) ~~trials~~as part of ~~our~~the ~~programs~~Make America Healthy Again Commission’s recent Strategy Report, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising. Additionally, the current administration recently called on Congress to enact “The Great Healthcare Plan,” to codify and ~~product~~expand ~~candidates~~Most-Favored inNation ~~our~~pricing, ~~later~~lower ~~preclinical~~government ~~studies~~subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and ~~clinical~~enact ~~trials~~restrictions on pharmacy benefit manager payment methodologies, weamong other things. These actions and policies may besignificantly ~~unable~~reduce toU.S. ~~successfully~~drug ~~develop~~prices, ~~obtain~~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 ~~for~~process and ~~commercialize~~make ~~our~~changes ~~product~~to ~~candidates.~~the Medicare Drug Price Negotiation Program.

~~Any~~At ~~results~~the ~~from~~state ~~our~~level, ~~early~~legislatures ~~preclinical~~have ~~studies~~increasingly passed legislation and ~~clinical~~implemented ~~trials~~regulations ofdesigned ~~our~~to ~~targeted~~control ~~oncology~~pharmaceutical ~~programs~~product ~~may~~pricing, ~~not~~including ~~necessarily~~price beor ~~predictive~~patient ofreimbursement ~~the~~constraints, ~~results~~discounts, ~~from~~restrictions ~~later~~on ~~preclinical~~certain ~~studies~~product access and ~~clinical~~marketing ~~trials.~~cost ~~Similarly~~disclosure and transparency measures, ~~even~~and, ifin wesome ~~are~~cases, ~~able~~designed to ~~complete~~encourage ~~our~~importation ~~planned~~from ~~preclinical~~other ~~studies~~countries and ~~clinical~~bulk ~~trials~~purchasing. ofIn ~~our~~addition, ~~product~~regional ~~candidates~~healthcare ~~according~~authorities and individual hospitals are increasingly using bidding procedures to ~~our~~determine ~~current~~what ~~development~~pharmaceutical ~~timeline,~~products ~~the~~and ~~results~~which ~~from~~suppliers ~~such~~will ~~preclinical~~be ~~studies~~included in their prescription drug and ~~clinical~~other ~~trials~~healthcare ofprograms. ~~our~~This could reduce the ultimate demand for a particular product ~~candidates~~or ~~may~~put ~~not~~pressure beon ~~replicated~~product inpricing, ~~subsequent~~which ~~preclinical~~could ~~studies~~negatively oraffect ~~clinical~~a ~~trial~~company’s business, financial condition, results. of operations and prospects.

~~Many~~Coverage ~~companies in the pharmaceutical~~ and biotechnology industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development, and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, preclinical and other nonclinical findings made while clinical trials were underway, or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported adverse events. Moreover, preclinical, nonclinical, and clinical data are often susceptible to varying interpretations and analyses and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain regulatory approval. Reimbursement

IfSales weof ~~continue~~our toproducts, ~~progress~~when ~~the~~and ~~development~~if ofapproved, ~~our~~will ~~product~~depend, ~~candidates~~in part, weon ~~may~~the ~~not~~extent to which our products will be ~~able~~covered toby ~~file~~third-party ~~INDs~~payors, orsuch ~~similar~~as ~~applications~~federal, ~~for~~state, ~~our~~and foreign government health programs, tocommercial ~~commence~~insurance ~~clinical~~and ~~trials~~managed onhealthcare organizations. In the ~~timelines~~United weStates, ~~expect~~no uniform policy of coverage and reimbursement for drug or biological products exists, and ~~even~~coverage ifand wereimbursement ~~are~~can ~~able~~differ significantly from payor to payor. Accordingly, decisions for any of our products, if approved, will be made on a payor-by-payor basis, and factors payors consider in determining the ~~FDA~~extent orof ~~other~~coverage ~~regulatory~~and ~~authorities~~amount ~~may~~of ~~not~~reimbursement ~~permit~~are usbased toon ~~proceed.~~whether the product is:

•

Ifa wecovered ~~continue~~benefit tounder progress the development of our product candidates we plan to progress candidates to INDs or similar applications, however, we may not be able to file such INDs or similar applications on the timelines we expect. Additionally, even if the FDA agrees with the design and implementation of the clinical trials set forth in an IND, we cannot guarantee that it will not change its ~~requirements~~health in the future. These considerations also apply to new clinical trials we may submit as amendments to existing INDs or similar applications to a new IND or similar application. Any failure to file INDs or similar applications on the timelines we expect or to obtain regulatory approvals for our clinical trials may prevent us from initiating or completing our clinical trials or commercializing our product candidates on a timely basis, if at all. plan;

~~Our~~Table ~~clinical trials or those~~ of our current or future collaborators may reveal significant adverse events not seen in our preclinical or nonclinical studies and may result in a safety profile that could inhibit regulatory approval or market acceptance of any of our product candidates. Contents

•

~~Before obtaining regulatory approvals for the commercial sale of any products~~safe, ~~we must demonstrate through lengthy, complex, and expensive preclinical studies and clinical trials that our product candidates are both safe and~~ effective ~~for use in each target indication. Clinical testing is expensive~~ and ~~can~~medically take many years to complete, and outcomes are inherently uncertain. Failure can occur at any time during the clinical trial process. Because our targeted oncology programs and our product candidates are in an early stage of development, there is a high risk of failure, and we may never succeed in developing marketable products. There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials also may fail to show the desired safety and efficacy profile despite having progressed through nonclinical studies and initial clinical trials. If the results of our clinical trials are inconclusive with respect to the safety and efficacy of our product candidates, if we do not meet the clinical endpoints with statistical and clinically meaningful significance, or if there are safety concerns associated with our product candidates, we may be prevented from, or delayed in, obtaining regulatory approval for such product candidates. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants. It is likely, as is the case with many oncology therapies, that there may be side effects associated with the use of our product candidates. Results of our trials could reveal a high and unacceptable severity and prevalence of side effects. In such an event, our trials could be suspended or terminated, and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. necessary;

•

~~Further,~~appropriate our product candidates could cause undesirable side effects in clinical trials related to on-target toxicity. If on-target toxicity is observed, or if our product candidates have characteristics that are unexpected, we may need to abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe, or more acceptable from a risk-benefit perspective. In addition, our product candidates could cause undesirable side effects that we have not yet observed. Many compounds that initially showed promise in early-stage testing for ~~treating cancer have later been found to cause side effects that prevented further development of~~ the ~~compound.~~specific Most product candidates that commence clinical trials are never approved as products, and there can be no assurance that any of our current or future clinical trials will ultimately be successful or support further clinical development or regulatory approval of any of our product candidates. patient;

•

We plan to develop certain of our product candidates, in combination with one or more cancer therapies. The uncertainty resulting from the use of our product candidates, in combination with other cancer therapies, may make it difficult to accurately predict side effects in future clinical trials. As is the case with many treatments for cancer and rare diseases, it is likely that there may be side effects associated with the use of our product candidates. If significant adverse events or other side effects are observed in any of our clinical trials, we may have difficulty recruiting patients to our clinical trials, patients may drop out of our trials, or we may be required to abandon the trials or our development efforts of one or more product candidates altogether. We, the FDA or other applicable regulatory authorities, or an IRB may suspend or terminate clinical trials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse side effects. Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in earlycost-~~stage~~effective; trials have later been found to cause side effects that prevented their further development. Even if the side effects do not preclude the product from obtaining or maintaining regulatory approval, undesirable side effects may inhibit market acceptance of the approved product due to its tolerability versus other therapies. Any of these developments could materially harm our business, operating results, financial condition, and ~~prospects.~~

•

~~Some~~neither ofexperimental ~~our~~nor product candidates modulate pathways for which there are currently no approved or effective therapies, and utilize novel binding locations, which may result in greater research and development expenses, regulatory issues that could delay or prevent approval, or discovery of unknown or unanticipated adverse effectsinvestigational.

•

~~Some~~In ofthe ~~our~~United ~~product~~States, ~~candidates~~for ~~modulate~~example, ~~pathways~~principal ~~for~~decisions ~~which~~about ~~there~~reimbursement ~~are~~for ~~currently~~new noproducts ~~approved~~are ortypically ~~effective~~made ~~therapies~~by CMS, which ~~may~~decides ~~result~~whether inand ~~uncertainty~~to ifwhat ~~development~~extent ~~continues~~a tonew ~~progress~~product will be covered and reimbursed under Medicare. WePrivate ~~have~~third-party ~~historically~~payors ~~selected~~often ~~programs~~follow ~~for~~CMS’s ~~cancer~~decisions ~~driver~~regarding ~~targets~~coverage ~~based~~and onreimbursement ~~compelling~~to ~~biological~~a ~~rationale~~substantial degree. WeHowever, ~~have~~one third-party payor’s determination to provide coverage for a product does not assure that other payors will also ~~explored~~provide ~~new~~coverage ~~programs~~for ~~based~~the onproduct ~~extensive~~As ~~preclinical~~a ~~data~~result, ~~analysis~~coverage ~~which~~determination ~~sometimes~~is ~~cannot~~often ~~predict~~a ~~efficacy~~time-consuming orand ~~safety~~costly inprocess ~~humans.~~that will require a company to provide scientific and clinical support for the use of its products to each payor separately, with no assurance that coverage and adequate reimbursement will be obtained.

~~Some~~The ofU.S. ~~our~~government, ~~product~~state ~~candidates~~legislatures ~~utilize~~and ~~novel~~foreign ~~binding~~governments ~~locations,~~have ~~which~~shown ~~may~~significant ~~result~~interest in ~~greater~~implementing ~~research~~cost ~~and~~containment ~~development~~programs ~~expenses,~~to ~~regulatory~~limit ~~issues~~the ~~that~~growth ~~could~~of ~~delay~~government-paid orhealth ~~prevent~~care ~~approval~~costs, orincluding ~~discovery~~price-controls, restrictions on reimbursement and requirements for substitution of ~~unknown~~biosimilars orfor ~~unanticipated~~branded ~~adverse~~prescription ~~effects~~drugs. WeFor ~~utilize~~example, ~~structural~~there ~~biology~~has been increasing legislative and enforcement interest in ~~tight~~the ~~integration~~U.S. with ~~our~~respect ~~medicinal~~to ~~chemistry~~specialty drug pricing practices. For example, HHS imposes rebates on many Medicare Part B and ~~biology~~Medicare ~~capabilities~~Part D products to ~~predict~~penalize ~~and~~price ~~design~~increases that outpace inflation on an annual basis. In addition, HHS has been empowered to negotiate the ~~compounds~~price of certain single-source biologics that have been on the market for at least eleven (11) years covered under Medicare as part of the Medicare Drug Price Negotiation Program. Each year up to twenty (20) products will ~~achieve~~be selected by HHS for the ~~most~~Medicare ~~desirable~~Drug ~~characteristics,~~Price ~~including~~Negotiation ~~potency,~~Program. ~~selectivity,~~Products ~~bioavailability,~~subject ~~and~~to ~~drug-like~~the ~~properties~~Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis. AAdoption ~~disruption~~of general controls and measures, coupled with the tightening of restrictive policies in ~~any~~jurisdictions with existing controls and measures, could limit payments for pharmaceutical drugs.

Assuming coverage is obtained for a given product by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. Further, coverage policies and third-party payor reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future. Patients who are prescribed medications for the treatment of their conditions, and their prescribing physicians, generally rely on third-party payors to reimburse all or part of the costs associated with their prescription drugs. Patients are unlikely to use products unless coverage is provided, and reimbursement is adequate to cover all or a significant portion of the cost of prescribed products.

In addition, in most foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing and reimbursement vary widely from country to country. For example, the EU provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product, or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. Historically, products launched in the EU do not follow price structures of the United States and generally prices tend to be substantially lower.

Human Resources

As of December 31, 2025, we had fifteen (15) full-time employees, eight (8) of which are engaged in research and development. None of our employees are represented by a labor union or covered by a collective bargaining agreement. We consider our relationship with our employees to be good. We are committed to recruiting talents necessary for our long-term success, including but not limited to, clinical, scientific, development, technical operations, regulatory, finance, and other functions.

Corporate Information

Ikena was incorporated under the laws of the State of Delaware in February 2016. Ikena was the successor in interest to KYN Therapeutics L.L.C., a limited liability company formed under the laws of the State of Texas in

ofTable ~~these capabilities may have significant adverse effects in our ability to expand our pipeline if we continue to progress the development~~ of our product candidates, and we cannot predict whether we will continue to have access to these capabilities in the future to support our potential pipeline development. In addition, there can be no assurance that we will be able to rapidly identify, design and synthesize the necessary compounds or that these or other problems related to the development of product candidates will not arise in the future, which may cause significant delays or we raise problems we may not be able to resolve. Contents

~~Regulatory~~September ~~approval~~2014. ofIn ~~novel~~December ~~product candidates such as ours can be more expensive~~2019, ~~riskier,~~Ikena ~~and~~changed ~~take~~its ~~longer~~name ~~than~~from ~~for~~Kyn ~~other~~Therapeutics, ~~more~~Inc. ~~well-known or extensively studied pharmaceutical or biopharmaceutical product candidates due~~ to ~~our~~Ikena ~~and~~Oncology, ~~regulatory agencies’ lack of experience with them~~Inc.(“Ikena”). ~~The~~On ~~novelty of~~ the ~~mechanism~~Closing ofDate, ~~action of any of our product candidates may lengthen~~ the ~~regulatory~~Merger ~~review process~~closed, ~~require~~and usthe toDelaware ~~conduct~~corporation ~~additional~~formerly ~~studies~~known oras ~~clinical~~“Ikena ~~trials~~Oncology, ~~increase~~Inc.” ~~our~~completed ~~development~~its ~~costs,~~previously ~~lead~~announced toMerger ~~changes~~with inLegacy ~~regulatory~~Inmagene ~~positions~~in ~~and~~accordance ~~interpretations,~~with ~~delay~~the orterms ~~prevent approval and commercialization~~ of ~~our~~the ~~product~~Merger ~~candidates~~Agreement, orpursuant ~~lead~~ to ~~significant~~which ~~post-approval~~(i) ~~limitations~~Ikena oreffected ~~restrictions.~~at ~~The~~1-for-12 ~~novel~~reverse ~~mechanism~~stock split of ~~action~~its ~~also~~common ~~means~~stock, ~~that~~(ii) ~~fewer~~Merger ~~people~~Sub ~~are~~I ~~trained~~merged ~~in or experienced~~ with ~~product candidates of this type, which may make it more difficult to find, hire~~ and ~~retain~~into ~~personnel~~Legacy ~~for research~~Inmagene, ~~development,~~with ~~and~~Legacy ~~manufacturing~~Inmagene ~~positions.~~surviving Ifthe ~~our~~First ~~inhibitors~~Merger ~~utilize~~as a ~~novel~~wholly-owned ~~mechanism~~subsidiary of ~~action~~Ikena, ~~that~~(iii) ~~has~~immediately ~~not~~following ~~been~~ the ~~subject~~First ofMerger, ~~extensive~~Legacy ~~study~~Inmagene ~~compared~~merged towith ~~more~~and ~~well-known~~into ~~product~~Merger ~~candidates~~Sub II, ~~there~~with isMerger ~~also~~Sub anII ~~increased~~surviving ~~risk~~the ~~that~~Second weMerger ~~may~~as ~~discover~~a ~~previously~~wholly ~~unknown~~owned orsubsidiary ~~unanticipated~~of ~~adverse~~Ikena ~~effects during our preclinical studies~~ and ~~clinical~~(iv) ~~trials.~~following ~~Any~~the ~~such~~Second ~~events~~Merger, ~~could~~Ikena ~~adversely~~changed ~~impact~~its ~~our~~name ~~business~~to ~~prospects~~“ImageneBio, ~~operating results and financial condition~~Inc.”

WeOur ~~currently~~principal ~~conduct~~executive ~~clinical~~offices ~~trials~~are ~~for~~located ~~our~~at ~~product~~12526 ~~candidates~~High ~~outside~~Bluff ~~the~~Drive, ~~United~~Suite ~~States~~345, ~~and~~San ~~the FDA~~Diego, ~~the~~CA ~~EMA~~92130, ~~the MHRA~~ and ~~comparable~~our ~~foreign~~telephone ~~regulatory~~number ~~authorities~~is ~~may~~(858) ~~not accept data from such trials~~345-6265.

WeOur ~~currently~~website ~~conduct~~address ~~additional~~is ~~clinical trials outside the United States, including in the United Kingdom, Australia, and other foreign jurisdictions~~imagenebio. ~~The acceptance of trial data from clinical trials conducted outside the United States by the FDA may be subject to certain conditions~~com. InOur ~~cases~~website ~~where~~is ~~data~~included ~~from clinical trials conducted outside the United States are intended to serve~~ as ~~the~~an ~~sole~~inactive ~~basis~~textual ~~for~~references ~~regulatory~~and ~~approval in~~ the ~~United~~information ~~States,~~contained ~~the FDA will generally not approve the application~~ on ~~the basis of foreign data alone unless (i) the data are applicable to the United States population and United States medical practices~~, ~~(ii) the trials were performed by clinical investigators of recognized competence, and (iii) the data may be considered valid without the need for an on-site inspection by the FDA~~ or, ifthat ~~the~~can ~~FDA considers such an inspection to~~ be ~~necessary,~~accessed ~~the FDA is able to validate the data~~ through ~~an on-site inspection or other appropriate means. Additionally~~, ~~the~~our ~~FDA’s~~website ~~clinical~~is ~~trial~~not ~~requirements,~~a ~~including~~part ~~sufficient size~~ of ~~patient~~this ~~populations~~Annual ~~and statistical powering, must be met~~Report. ~~The~~All ~~EMA,~~brand ~~the~~names ~~MHRA~~or ~~and~~trademarks ~~many~~appearing ~~other~~in ~~comparable~~this ~~foreign~~Annual ~~regulatory~~Report ~~bodies have similar approval requirements. In addition, such foreign trials~~ are ~~subject to~~ the ~~applicable~~property ~~local laws~~ of ~~the~~their ~~foreign~~respective ~~jurisdictions where the trials are conducted~~holders. ~~There~~Use ~~can be no assurance that the FDA, the EMA, the MHRA,~~ or ~~any~~display ~~comparable~~by ~~foreign~~us ~~regulatory authority will accept data from trials conducted outside~~ of ~~the~~other ~~United~~parties’ ~~States~~trademarks, ~~the~~trade EUdress, ~~the United Kingdom,~~ or ~~the~~products ~~applicable~~in ~~jurisdiction.~~this IfAnnual ~~the~~Report ~~FDA,~~is ~~the~~not ~~EMA,~~intended ~~or the MHRA~~to, orand ~~any comparable foreign regulatory authority~~ does not ~~accept such data~~, itimply ~~would~~a ~~result~~relationship ~~in the need for additional trials~~with, ~~which~~or ~~would~~endorsements beor ~~costly~~sponsorship ~~and time-consuming and delay aspects~~ of ~~our business plan~~, ~~and~~us ~~which~~by ~~may~~the ~~result~~trademark ~~in our product candidates not receiving regulatory approval~~ or ~~clearance~~trade ~~for~~dress ~~commercialization in the applicable jurisdiction~~owners.

IfAvailable we continue to progress the development of our product candidates, we may fail to identify viable new product candidates for clinical development for a number of reasons. If we fail to identify additional product candidates, our business could be materially harmed. Information

IfOur weAnnual ~~continue~~Report toon ~~progress~~Form ~~development~~10-K, ~~research~~Quarterly ~~programs~~Reports on Form 10-Q and Current Reports on Form 8-K and amendments to ~~pursue~~those ~~the~~reports ~~development~~filed or furnished pursuant to Sections 13(a) or 15(d) of the Exchange Act are available on our ~~product~~website, ~~candidates~~free ~~for~~of ~~additional~~charge, ~~indications~~as ~~and~~soon ~~disease~~as ~~targets~~reasonably ~~require~~practicable ~~substantial~~after ~~technical~~the reports are electronically filed or furnished to the SEC. The SEC maintains a website at www.sec.gov that contains reports, ~~financial~~proxy and ~~human~~information ~~resources~~statements, ~~whether~~and orother ~~not~~information ~~they~~that ~~are~~we ~~ultimately~~file ~~successful~~with the SEC electronically. ~~Our~~We ~~research~~intend ~~programs~~to ~~may~~announce ~~initially~~material ~~show~~information ~~promise~~to inthe ~~identifying~~public ~~potential~~through ~~indications~~filings with the SEC, ~~yet~~the ~~fail~~investor torelations ~~yield~~page ~~results~~on ~~for~~our ~~clinical~~website, ~~development~~which ~~for~~is alocated ~~number~~at ofwww.imagenebio.com, ~~reasons~~press releases, ~~including:~~public conference calls, and public webcasts.

The information disclosed through the ~~research~~foregoing ~~methodology~~channels ~~used~~could ~~may~~be deemed to be material information. As such, we encourage investors, the media, and others to follow the channels listed above and to review the information disclosed through such channels. The information we post through these channels is not a part of this Annual Report. Any updates to the list of disclosure channels through which we will announce information will be ~~successful~~posted inon ~~identifying~~the ~~potential~~investor ~~indications;~~relations page on our website.

potential product candidates may, after further study, be shown to have harmful adverse effects or other characteristics that indicate they are unlikely to be effective products; or

it may take greater human and financial resources than we will possess to identify additional therapeutic opportunities for our product candidates, thereby limiting our ability to develop, diversify and expand our product portfolio.

Because we have limited financial and human resources, we initially focused on research programs and product candidates for a limited set of indications. As a result, opportunities with other product candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success were not prioritized. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.

~~Accordingly,~~Table ~~if we continue to progress the development~~ of our product candidates, there can be no assurance that we will ever be able to identify additional therapeutic opportunities, which could materially adversely affect our future growth and prospects. We may focus our efforts and resources on other potential programs that ultimately prove to be unsuccessful. Contents

IfItem we1A. ~~continue~~Risk to progress the development of our product candidates and are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impairedFactors.

~~Our~~An ~~product~~investment ~~candidates~~in ~~and~~our ~~the~~common ~~activities~~stock ~~associated~~involves ~~with~~a ~~their~~high ~~development~~degree ~~and~~of ~~commercialization,~~risk. ~~including~~In ~~their~~addition ~~design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, distribution, import and export are subject~~ to ~~comprehensive regulation by~~ the ~~FDA~~risk and ~~other~~uncertainties ~~regulatory~~described ~~agencies~~under in the ~~United~~section ~~States~~titled ~~and~~“Special byNote ~~comparable~~Regarding ~~foreign~~Forward-Looking ~~regulatory~~Statements,” ~~authorities.~~you ~~Before~~should weconsider ~~can~~carefully ~~commercialize~~the ~~any~~risks ofand ~~our~~uncertainties ~~product~~described ~~candidates~~below, wetogether ~~must~~with ~~obtain regulatory approval. Currently,~~ all of ~~our~~the ~~product~~other ~~candidates~~information ~~are~~contained in ~~discovery,~~this ~~preclinical~~Annual ~~or clinical development~~Report, ~~and~~including ~~we have not received approval to market any of~~ our ~~product~~consolidated ~~candidates~~financial ~~from~~statements ~~regulatory~~and ~~authorities~~related innotes ~~any~~and ~~jurisdiction. It is possible that our product candidates, if we seek to develop them in~~ the ~~future,~~section ~~will~~titled ~~never~~“Management’s ~~obtain~~Discussion ~~regulatory approval. We have limited experience in filing~~ and ~~supporting~~Analysis ~~the~~of ~~applications~~Financial ~~necessary~~Condition ~~to gain regulatory approvals~~ and ~~expect~~Results toof ~~rely~~Operations”, onbefore ~~third-party~~deciding ~~CROs and/or regulatory consultants~~ to ~~assist~~invest us in ~~this~~our ~~process~~common stock. ~~Securing~~If ~~regulatory~~any ~~approval~~of ~~requires~~ the ~~submission~~following ofevents ~~extensive~~occur, ~~preclinical~~our ~~and~~business, ~~clinical~~financial ~~data~~condition and ~~supporting~~operating ~~information~~results tomay ~~the~~be ~~various~~materially ~~regulatory~~adversely ~~authorities for each therapeutic indication to establish the product candidate’s safety and efficacy~~affected. ~~Securing~~In ~~regulatory~~that ~~approval~~event, ~~also requires~~ the ~~submission~~trading price of ~~information~~our ~~about~~common ~~the~~stock ~~product~~could ~~manufacturing process to~~decline, and ~~inspection~~you ofcould ~~manufacturing~~lose ~~facilities~~all ~~by,~~or ~~the~~part ~~relevant~~of ~~regulatory~~your ~~authority~~investment. ~~Our~~The ~~product~~risks ~~candidates~~and ~~may~~uncertainties ~~not~~described bebelow ~~effective,~~are ~~may~~not bethe only ~~moderately~~ones ~~effective,~~we orface. ~~may~~Additional ~~prove~~risks toand ~~have~~uncertainties ~~undesirable~~that orwe ~~unintended~~are ~~side~~unaware ~~effects~~of, ~~toxicities~~ or ~~other characteristics~~ that ~~may~~we ~~preclude~~currently ~~our~~believe ~~obtaining~~are ~~regulatory~~not ~~approval~~material, ormay ~~prevent~~also orbecome ~~limit~~important ~~commercial~~factors ~~use.~~that Inadversely ~~addition,~~affect ~~regulatory authorities may find fault with~~ our ~~manufacturing~~business ~~process~~ or ~~facilities~~results ~~or that~~ of ~~third-party contract manufacturers~~operations. ~~We may also face greater than expected difficulty in manufacturing our product candidates.~~

~~The~~Risks ~~process~~Related ~~of obtaining regulatory approvals, both in the United States and abroad, is expensive and often takes many years. If we continue~~ to ~~progress~~Our ~~the~~Limited ~~development~~Operating ~~of our product candidates and the FDA or a comparable foreign regulatory authority requires that we perform additional preclinical studies or clinical trials~~History, ~~approval~~Financial ~~may~~Position ~~be delayed, if obtained at all. The length of such a delay varies substantially based upon a variety of factors, including the type, complexity~~ and ~~novelty~~Need of the product candidate involved. Changes in regulatory approval policies during the development period, changes in or enactment of additional statutes or regulations, or changes in regulatory review policies for ~~each~~Additional submitted NDA, PMA, or equivalent application types, may cause delays in the approval or rejection of an application. The FDA and comparable foreign regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studies. Our product candidates could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including the following: Capital

~~the~~We ~~FDA~~are ora ~~comparable~~clinical-stage ~~foreign~~biopharmaceutical ~~regulatory~~company ~~authorities~~with ~~may~~a ~~disagree~~limited ~~with~~operating ~~the~~history, ~~design~~which ormay ~~implementation~~make ofit difficult to evaluate our ~~clinical~~current ~~trials;~~business and predict our future performance.

weWe ~~may~~are ~~not~~a beclinical-stage ~~able~~biopharmaceutical tocompany ~~enroll~~with a ~~sufficient~~limited ~~number~~operating ofhistory. ~~patients~~Our inoperations to date have focused on organizing and staffing our ~~clinical~~operations, business planning, raising capital, establishing our intellectual property portfolio and conducting preclinical studies; and clinical trials of IMG-007. We have not yet demonstrated an ability to successfully manufacture, obtain marketing approvals for or commercialize IMG-007. We have no products approved for commercial sale and have not generated any revenue from product sales. Consequently, any predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history.

weWe ~~may~~are befocused ~~unable~~on tothe ~~demonstrate~~discovery toand development of innovative drugs for the ~~satisfaction~~treatment of various immunological, autoimmune and inflammatory diseases. Our limited operating history, particularly in light of the ~~FDA~~rapidly orevolving ~~comparable~~drug ~~foreign~~research and development industry in which we operate and the changing regulatory ~~authorities~~and ~~that~~market environments we encounter, may make it difficult to evaluate our prospects for future performance. As a ~~product~~result, ~~candidate~~any assessment of our future performance or viability is ~~safe~~subject to significant uncertainty. We will encounter risks and ~~effective~~difficulties ~~for~~frequently ~~its~~experienced ~~proposed~~by ~~indication~~early-stage orcompanies ain ~~related~~rapidly ~~companion~~evolving ~~diagnostic~~fields isas ~~suitable~~we seek to ~~identify~~transition ~~appropriate~~to ~~patient~~a ~~populations;~~company capable of supporting commercial activities. If we do not address these risks and difficulties successfully, our business will suffer.

~~the~~We ~~results~~expect ofto ~~clinical~~incur ~~trials~~significant ~~may~~losses ~~not~~for ~~meet~~ the ~~level~~foreseeable offuture ~~statistical~~and ~~significance~~may ~~required~~never byachieve ~~the FDA~~ or ~~comparable~~maintain ~~foreign regulatory authorities for approval;~~ profitability.

weInvestment ~~may~~in bebiopharmaceutical ~~unable~~product development is highly speculative because it entails substantial upfront capital expenditures and the significant risk that product candidates will fail to demonstrate ~~that~~adequate aefficacy ~~product~~or ~~candidate’s~~an ~~clinical~~acceptable safety profile, gain regulatory approval or become commercially viable. For the year ended December 31, 2025 and ~~other~~the ~~benefits~~year ~~outweigh~~ended ~~its~~December ~~safety~~31, ~~risks;~~2024, our net losses were $45.3 million and $36.6 million, respectively. As of December 31, 2025, we had an accumulated deficit of $230.1 million. Substantially all of our losses have resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

We expect to continue to incur significant expenses and additional operating losses for the ~~FDA~~foreseeable future as we seek to advance IMG-007 through clinical development, expand our research and development activities, develop new product candidates, complete clinical trials, seek regulatory approval and, if we receive regulatory approval, commercialize our products. Furthermore, the costs of advancing product candidates into each succeeding clinical phase tend to increase substantially over time. The total costs to advance IMG-007 or ~~comparable~~any ~~foreign~~future product candidate to regulatory ~~authorities~~approval ~~may~~in ~~disagree~~even a single jurisdiction would be substantial. Because of the numerous risks and uncertainties associated with ~~our~~product ~~interpretation~~development, we are unable to accurately predict the timing or amount of ~~data~~increased expenses or when, or if, we will be able to generate any revenue from ~~preclinical~~the ~~studies~~commercialization of any approved products or achieve or maintain profitability. Our expenses will also increase substantially as we operate as a public company following the Merger and add clinical, ~~trials;~~scientific, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.

the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere;

the FDA or comparable foreign regulatory authorities may find deficiencies with or 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 such that our clinical data are insufficient for approval.

~~Even~~Table if we were to complete development and obtain regulatory approval, regulatory authorities may approve any product candidates for fewer or more limited indications than we request, thereby narrowing the commercial potential of the product candidate. In addition, regulatory authorities may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates. Contents

IfWe cannot generate any revenue from product sales unless and until we ~~continue~~obtain toregulatory ~~progress~~approvals ~~the~~for ~~development~~IMG-007 ofand ~~our~~any future product candidates in our desired jurisdictions, successfully manufacture IMG-007 and ~~experience~~any ~~delays~~future inproduct ~~obtaining~~candidates, orand successfully build a commercial organization. These activities will require substantial investment and significant marketing efforts. Our expenses could increase beyond expectations if we ~~fail~~are torequired ~~obtain~~by the FDA, ~~approval~~the EMA, the ~~commercial~~competent ~~prospects~~authorities ~~for~~of individual EU Member States or comparable foreign regulatory authorities to perform additional preclinical studies and clinical trials and/or to modify any of our manufacturing processes or make other changes to IMG-007 or any future product candidates ~~may~~than bethose ~~harmed~~that ~~and~~we ~~our~~currently ~~ability~~anticipate. As a result, we expect to ~~generate~~continue ~~revenue~~to ~~will~~incur benet ~~materially~~losses ~~impaired~~and negative cash flows for the foreseeable future. These net losses and negative cash flows have had, and will continue to have, an adverse effect on our stockholders’ equity and working capital.

~~Pandemics~~As we continue to build our business, ~~epidemics~~we expect our financial condition and operating results may fluctuate significantly from quarter to quarter and year to year due to a variety of factors, ormany of which are beyond our control. Accordingly, you should not rely upon the results of any ~~outbreak~~particular quarterly or annual period as indications of anfuture ~~infectious~~operating ~~disease~~performance. If we are unable to develop, ~~may~~obtain ~~materially~~regulatory approval, and ~~adversely~~successfully ~~affect~~commercialize ~~our~~IMG-007 ~~business~~or ~~and~~any ~~our~~future ~~financial~~product ~~results~~candidate either alone or with collaborators, or if revenues from IMG-007 and ~~could~~any ~~cause~~future aproduct ~~disruption~~candidates that receive regulatory approval are insufficient, we will not achieve profitability. Even if we do achieve profitability, we may not be able to ~~the~~sustain ~~continued~~or ~~development~~increase profitability. If we are unable to achieve and then maintain profitability, the value of our ~~product~~securities ~~candidates~~will be adversely affected.

~~Public~~We ~~health~~will ~~crises~~need ~~such~~to asobtain ~~pandemics~~substantial oradditional ~~similar~~funding ~~outbreaks~~to ~~could~~complete ~~adversely~~the ~~impact~~development ~~our~~and ~~business.~~any ~~Such~~commercialization ~~global outbreaks~~ of ~~infectious~~IMG-007 ~~diseases could materially~~ and ~~adversely~~any ~~impact~~future ~~our~~product ~~operations~~candidates, ~~including,~~which ~~without~~may ~~limitation,~~cause ~~our~~dilution ~~nonclinical~~to ~~studies or clinical trial operations and~~ our ~~ability to recruit and retain patients and principal investigators and site staff~~stockholders. ~~For~~If ~~example, if~~ we ~~continue~~are unable to ~~progress~~raise ~~the~~this ~~development~~capital ofwhen ~~our~~needed, ~~product candidates~~ we may ~~experience~~be ~~delays~~forced into ~~initiating IND-enabling studies~~delay, ~~enrolling~~reduce ~~our clinical trials,~~ or ~~dosing~~eliminate ~~of patients in~~ our ~~clinical~~research ~~trials,~~ and ~~activating~~development ~~new~~programs ~~trial sites, as well as protocol deviations. Any negative impact a public health crisis has on patient enrollment~~ or ~~treatment~~other or the execution of our clinical trials could cause costly delays to clinical trial activities, which could adversely affect our ability to obtain regulatory approval for and to commercialize our product candidates, increase our operating expenses, and have a material adverse effect on our financial resultsoperations.

~~These,~~The development of biopharmaceutical product candidates is capital-intensive. We expect to spend substantial amounts to advance IMG-007 and ~~other~~any ~~factors~~future ~~related~~product candidate into clinical development and to complete the clinical development of, seek regulatory approvals for and commercialize IMG-007 and any ~~such~~future ~~disruptions~~product ~~that~~candidate, ~~are~~if ~~unforeseen~~approved. In addition, ~~could~~as ~~have~~IMG-007 progresses through development and toward commercialization, we will need to make certain milestone payments to HUTCHMED Limited (formerly known as Hutchinson Medipharma Limited) (“Hutchmed”) under a ~~material~~collaboration, ~~adverse~~option ~~effect~~and onlicense ~~our~~agreement ~~business~~with Hutchmed (as amended, the “Hutchmed Agreement”) and ~~our~~tiered ~~results~~royalties from commercial sales of ~~operation~~IMG-007, if approved. We will require additional capital to support our product development efforts and ~~financial~~operations, ~~condition.~~which ~~Further~~we may raise through public or private equity or debt financings or other capital sources, ~~uncertainty~~which ~~around~~may ~~these~~include strategic collaborations and ~~related~~other ~~issues~~strategic ~~could~~arrangements ~~lead~~with third parties, to ~~adverse~~enable ~~effects~~us onto ~~global~~complete ~~economies~~the development and ~~financial~~potential ~~markets~~commercialization of IMG-007 and any future product candidates. Adequate additional financing may not be available to us on acceptable terms, ~~which~~or ~~could~~at ~~impact~~all. Our failure to raise capital as and when needed would have a negative effect on our financial condition and our ability to ~~raise~~pursue our business strategy. In addition, attempting to secure additional financing may divert the ~~necessary~~time and attention of our management from day-to-day activities and harm our development efforts. If we are unable to raise capital when needed or on acceptable terms, we would be forced to ~~develop~~delay, ~~and~~reduce ~~commercialize~~or eliminate certain of our ~~programs~~research and ~~product~~development ~~candidates~~programs.

IfOur weoperations ~~continue~~have toconsumed ~~progress~~significant ~~the~~amounts ~~development~~ of ~~our~~cash ~~product~~since ~~candidates,~~inception. weAs ~~may~~of ~~need~~December to31, ~~reformulate~~2025, our ~~product~~cash ~~candidates~~and ~~which~~cash ~~could~~equivalents ~~require~~and ~~additional~~marketable ~~nonclinical~~securities ~~studies~~were or$135.3 ~~clinical~~million. ~~trials~~Because the length of time and ~~delay~~activities ~~the~~associated with successful development orof ~~regulatory~~IMG-007 ~~approval~~and ofany ~~such~~future product candidates are highly uncertain, we are unable to estimate the actual funds we will require for development and any marketing and commercialization activities.

~~New risks, pharmacokinetic variability, and side effects associated with our product candidates may be discovered during clinical testing.~~ Our ~~product~~future ~~candidates~~funding ~~also may experience stability issues. For these or other reasons~~requirements, ifboth wenear- ~~continue~~and to progress the development of our product candidates we may need to reformulate them. Such reformulation may require us to conduct additional nonclinical studies or clinical trials to bridge or demonstrate the comparability of our modified product candidate to earlier versionslong-term, which could delay our clinical development plan or marketing approval for our product candidate. Reformulating a product candidate may also result in a delay in continuing a clinical trial. There can be no assurance that we will ~~not~~depend ~~experience~~on ~~delays~~many infactors, the completion of a clinical trial or in the commencement and completion of our future trials due to the need to reformulate our product candidates and subsequently discuss with or receive authorization from regulatory authorities to implement these changes in clinical trials. Additionallyincluding, ~~reformulating~~but anot ~~product~~limited ~~candidate may cause us~~ to experience a shortage in supply or cause the cost to manufacture our product candidate to increase. Any reformulation of our product candidates could substantially increase the costs and expenses of developing our product candidates and delay such development and marketing approval. :

•

~~Risks~~the ~~Related~~type, tonumber, ~~Commercialization~~scope, progress, expansions, results, costs and timing of, discovery, preclinical studies and clinical trials of IMG-007 and any future product candidates;

•

Wethe ~~face~~costs ~~substantial~~and ~~competition,~~timing ~~which~~of ~~may~~manufacturing ~~result~~for inIMG-007 ~~others~~and ~~discovering,~~any ~~developing,~~future orproduct ~~commercializing~~candidates, ~~products~~including ~~before or more successfully than we do~~ if we ~~continue~~develop toour ~~progress~~own ~~development.~~manufacturing capabilities;

•

~~The development and commercialization of new products in~~ the ~~biopharmaceutical and related industries is highly competitive. We compete in the segments of the pharmaceutical~~outcome, ~~biotechnology,~~timing and other related markets that address structural biology-guided chemistry-based drug design to develop therapies in the fields of cancer and genetic diseases. There are other companies focusing on targeted oncology to develop therapies in the fields of cancer and other diseases. We also compete more broadly across the market for cost~~-effective~~ ~~and reimbursable cancer treatments. Some~~ of ~~these~~meeting ~~competitive~~regulatory ~~products~~requirements ~~and~~established ~~therapies~~by ~~are based on scientific approaches that are~~ the ~~same~~FDA ~~as or similar to our approach,~~ and ~~others~~comparable ~~are~~foreign ~~based~~regulatory on entirely different approaches. These companies include divisions of large pharmaceutical companies and biotechnology companies of various sizes. We face competition with respect to product candidates from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. Potential competitors also include academic institutions, government agencies and other public and private research authorities;

~~organizations~~Table ~~that~~of ~~conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and commercialization.~~ Contents

•

~~Any product candidates that we successfully develop and commercialize will compete with currently approved therapies and new therapies that may become available in~~ the ~~future~~cost ~~from segments~~ of ~~the pharmaceutical~~obtaining, ~~biotechnology~~maintaining and ~~other~~protecting ~~related markets. Key product features that would affect~~ our ~~ability~~intellectual toproperty ~~effectively~~portfolio, ~~compete~~including ~~with other therapeutics include the efficacy~~filing, ~~safety~~prosecuting, defending and ~~convenience~~enforcing of our ~~products.~~patent Weclaims ~~believe~~and ~~principal competitive factors to our business include, among~~ other ~~things,~~intellectual ~~our~~property ~~ability to identify biomarkers, ability to successfully transition research programs into clinical development, ability to raise capital, and the scalability of the platform, pipeline, and business.~~ rights;

•

~~Many of~~ the ~~companies~~cost ~~that~~of weestablishing ~~compete~~a ~~against or which we may compete against in the future have significantly greater financial resources and expertise in research and development~~sales, ~~manufacturing, preclinical and clinical testing, obtaining regulatory approvals, and~~ marketing ~~approved products than we do. Mergers~~ and ~~acquisitions~~distribution ininfrastructure ~~the~~to ~~pharmaceutical,~~commercialize ~~biotechnology, and diagnostic industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early~~IMG-~~stage~~007 ~~companies may also prove to be significant competitors, particularly through collaborative arrangements with large~~ and ~~established~~any ~~companies.~~future ~~These~~product ~~competitors~~candidates ~~also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration~~ for ~~clinical~~which ~~trials,~~we ~~as well as in acquiring technologies complementary to, or necessary for, our programs. If these or other barriers to entry do not remain in place, other companies~~ may beobtain ~~able~~regulatory ~~to more directly or effectively compete with us.~~ approval;

•

~~Our~~the ~~commercial~~timing ~~opportunity could be reduced or eliminated if our competitors develop~~ and ~~commercialize~~amount ~~products~~of ~~that are safer~~royalty, ~~more~~milestone ~~effective, have fewer~~ or ~~less~~other ~~severe~~payments ~~side~~made ~~effects,~~to ~~are more convenient or are less expensive than any products that we or~~ our ~~collaborators~~current ~~may develop. Our competitors also may obtain FDA~~ or ~~other~~future ~~regulatory approval for their products sooner than we may obtain approval for ours~~suppliers, ~~which~~collaborators ~~could result in our competitors establishing a strong market position before we~~ or our collaborators are able to enter the market. The key competitive factors affecting the success of all of our product candidates, if approved, are likely to be their efficacy, safety, convenience, price, level of generic competition and availability of reimbursement from government and other third-party payors.licensors;

•

If the ~~market~~timing ~~opportunities for our programs~~ and ~~product~~amount ~~candidates~~of ~~are~~the ~~smaller~~milestone ~~than we estimate~~ or ifother ~~any~~payments ~~regulatory~~made ~~approval~~to ~~that~~us weunder ~~obtain is based on a narrower definition of the patient population,~~ our ~~revenue~~current ~~and~~or ~~ability~~any tofuture ~~achieve~~collaboration ~~profitability~~or ~~will~~licensing ~~be adversely affected, possibly materially.~~ agreements;

•

~~The~~costs ~~incidence~~associated ~~and~~with ~~prevalence~~growing ~~for target patient populations of~~ our ~~programs~~workforce and ~~product~~retaining candidates have not been established with precision. Our IK-595 program candidate is an oral, small molecule MEK-RAF molecular glue. KRAS mutations in the RAS signaling pathway occur in approximately 26% of all cancers. Our projections of both the number of people who have these diseases, as well as the subset of people with these diseases who have the potential to benefit from treatment with our current program and ~~product~~motivating ~~candidate, are based on~~ our ~~estimates.~~employees;

•

~~The total addressable market opportunity will ultimately depend upon, among other things,~~ the ~~diagnosis criteria included in the final label~~initiation, ~~the indications for which our product candidates are approved for sale~~progress, ~~acceptance~~timing ~~by the medical community~~ and ~~patient~~results ~~access, product pricing, and reimbursement. The number~~ of ~~patients with the cancers and solid tumors for which~~ our ~~product~~commercialization candidates may be approved as treatment may turn out to be lower than expected, patients may not be otherwise amenable to treatment with our products, or new patients may become increasingly difficult to identify or gain access to, all of ~~which~~IMG-007 ~~would adversely affect our results of operations~~ and ~~our~~any ~~business.~~future ~~If we continue to progress development of our~~ product candidates, ~~our~~if ~~prioritization~~approved offor ~~development~~commercial ~~of certain product candidates over others may prove to be the wrong choice and adversely affect our business.~~ sale;

•

Ifcosts weassociated ~~continue~~with toany ~~progress~~products ~~the~~or ~~development~~technologies ~~of our product candidates and our product candidates do not achieve broad market acceptance, the revenue~~ that we ~~generate from their sales~~ may bein-license ~~limited,~~or ~~and we may never become profitable.~~ acquire;

•

~~We have never commercialized a product candidate for any indication. Even if we continue to progress development and our current product candidates and any future product candidates are approved by~~ the ~~appropriate~~costs ~~regulatory~~associated ~~authorities~~with ~~for~~being marketing and sale, they may not gain acceptance among physicians, patients, third-party payors, and others in the medical community. If any product candidates for which we obtain regulatory approval do not gain an adequate level of market acceptance, we may not generate significant revenue and may not become profitable or may be significantly delayed in achieving profitability. Market acceptance of our current product candidates and any future product candidates by the medical community, patients and third-party payors will depend on a number of factors, some of which are beyond our control. For example, physicians are often reluctant to switch their patients, and patients may be reluctant to switch, from existing therapies even when new and potentially more effective or safer treatments enter the market. If public ~~perception~~company; is influenced by claims that the use of targeted oncology is unsafe, whether related to our or our competitors’ products, our products may not be accepted by the general public or the medical community. Future adverse and

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our implementation of additional internal systems and infrastructure, including operational, financial and management information systems.

In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a holder of our equity securities. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Risks Related to the Discovery and Development of our Product Candidates

Our business is entirely dependent on the success of IMG-007 for the treatment of AD and for other potential indications.

On July 25, 2025, immediately prior to consummation of the Merger, Legacy Inmagene consummated the divestiture of the non-IMG-007 business related assets, business and operations (the “Non-OX40 Business”) controlled by Legacy Inmagene immediately prior to the Merger. Accordingly, our business is entirely dependent on the success of IMG-007 for the treatment of AD and other potential indications. IMG-007 is currently in Phase 2 development for the treatment of moderate-to-severe AD. We may also develop IMG-007 for other immunological, autoimmune and inflammatory diseases such as AA, asthma rheumatoid arthritis, and hidradenitis suppurativa. We cannot give any assurance that we will generate preclinical, clinical or other data for IMG-007 for the treatment of AD or other immunological, autoimmune and inflammatory diseases sufficiently supportive to receive regulatory approval, which will be required before IMG-007 can be commercialized. We may, among other things, experience difficulties with patient recruitment, enrollment and retention, quality and provision of materials and supplies necessary to manufacture sufficient quantities of drug product to meet our current or future preclinical study and clinical trial needs on a timely basis, or safety signals or pharmacodynamic, pharmacokinetic or efficacy data that does not align with our target profile for IMG-007. IMG-007 will require significant further clinical development, regulatory review and approval, substantial investment, access to sufficient commercial manufacturing capacity, and significant marketing efforts before we can generate any revenue from product sales.

~~events~~Table in targeted oncology, immune-oncology or the biopharmaceutical industry could also result in greater governmental regulation, stricter labeling requirements, and potential regulatory delays in the testing or approvals of ~~our product candidates.~~Contents

InThe ~~the~~success ~~United~~of ~~States~~our ~~and markets in other countries~~business, ~~patients~~including ~~generally~~our ~~rely~~ability onto ~~third-party~~finance ~~payors~~our tocompany ~~reimburse~~and ~~all~~generate orany ~~part~~revenue ofin the ~~costs~~future, ~~associated~~will ~~with~~primarily ~~their~~depend ~~treatment.~~on ~~Adequate~~the ~~coverage~~successful ~~and reimbursement from governmental healthcare programs~~development, ~~such~~regulatory asapproval ~~Medicare~~ and ~~Medicaid,~~commercialization ~~and~~of ~~commercial~~IMG-007, ~~payors~~which ismay ~~critical~~never ~~to new product acceptance~~occur. ~~Our~~If ~~ability~~we toare ~~successfully~~unable ~~commercialize our product candidates will depend in part on the extent~~ to ~~which~~develop, ~~coverage~~or ~~and~~obtain ~~adequate~~regulatory ~~reimbursement~~approval for ~~these products and related treatments will be available from government health administration authorities~~, ~~private health insurers~~or, ~~and other organizations. Even~~ if ~~coverage is provided~~approved, ~~the~~successfully ~~approved~~commercialize ~~reimbursement~~IMG-007, ~~amount~~we may not be ~~high~~able ~~enough~~ to ~~allow~~generate ~~us to establish or maintain pricing~~ sufficient revenue to ~~realize~~continue ~~a sufficient return on~~ our ~~investment.~~business ~~Government authorities~~ and ~~third-party~~our ~~payors,~~business ~~such~~would asbe ~~private~~materially ~~health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels~~harmed.

~~Efforts~~Interim, totopline ~~educate the medical community~~ and ~~third-party~~preliminary ~~payors~~data onfrom ~~the benefits of~~ our ~~current~~preclinical ~~product~~studies ~~candidates~~or ~~and~~clinical ~~any~~trials ~~future~~that ~~product~~we ~~candidates~~announce ~~may~~or ~~require~~publish ~~significant~~from ~~resources~~time ~~and~~to time may not be ~~successful.~~predictive Ifof ~~our~~future ~~current~~results ~~product~~and ~~candidates~~may orchange ~~any~~as ~~future~~more ~~product~~patient ~~candidates~~data ~~are~~become ~~approved~~available ~~but~~and doare ~~not~~subject ~~achieve~~to anaudit ~~adequate~~and ~~level~~verification ~~of market acceptance~~procedures, wewhich could beresult ~~prevented from or significantly delayed~~ in ~~achieving~~material ~~profitability.~~changes ~~The~~to ~~degree~~the offinal ~~market acceptance of any of our current product candidates and any future product candidates will depend on a number of factors, including:~~ data.

From time to time, we may publicly disclose interim, topline or preliminary data from our preclinical studies, clinical trials or planned clinical trials, which is based on a preliminary analysis of then-available data. The results and related findings and conclusions are subject to change following a more comprehensive review of the ~~efficacy~~data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our ~~current~~analyses ~~product~~of ~~candidates~~data, and ~~any~~we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, topline or preliminary results that we report may differ from future ~~product~~results ~~candidates~~of asthe ~~single~~same ~~agents~~studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Interim, topline and preliminary data also remain subject to audit and verification procedures that may result in ~~combination~~the final data being materially different from the preliminary data we previously published. As a result, such data should be viewed with ~~marketed~~caution ~~checkpoint~~until ~~inhibitor~~the ~~immunotherapies~~final data are available. From time to time, ~~targeted~~we ~~agents~~may also disclose interim data from our clinical trials. Interim, topline, or preliminary data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and ~~other~~more ~~combination~~patient ~~agents;~~data become available. Adverse differences between interim, topline or preliminary data and final data could significantly harm our business prospects.

~~the~~Further, ~~commercial~~others, ~~success~~including regulatory authorities, 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 ~~checkpoint~~value, ~~inhibitor~~approvability ~~immunotherapy~~or ~~drugs~~commercialization of IMG-007 or any future product candidate, ~~targeted~~and ~~agents~~our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and ~~other~~you ~~combination~~or ~~agents~~others may not agree with ~~which~~what we determine is the material or otherwise appropriate information to include in our ~~products~~disclosure, and any information we determine not to disclose may ultimately be codeemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product, product candidate or our business. If the interim, topline or preliminary data that we report differ from actual results, or if others including comparable foreign regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, IMG-~~administered;~~007 or any future product candidates may be harmed, which could harm our business, operating results, prospects or financial condition.

~~the~~Moreover, ~~prevalence~~results from previous preclinical studies or clinical trials are not necessarily predictive of future clinical trial results, and ~~severity~~interim results of ~~adverse~~a ~~events~~clinical ~~associated~~trial ~~with~~are ~~our~~not ~~current~~necessarily ~~product~~indicative ~~candidates~~of ~~and~~final results. IMG-007 or any future product candidates ormay ~~those~~fail ~~products~~to ~~with~~show ~~which~~the ~~they~~desired ~~may~~safety beand ~~co-administered;~~efficacy in clinical development despite positive results in preclinical studies of such product candidates or having successfully advanced through initial clinical trials.

~~the~~Clinical ~~clinical~~trials ~~indications~~are ~~for~~expensive, ~~which~~time-consuming, ~~our~~difficult ~~product~~to ~~candidates~~design ~~are~~and ~~approved~~implement, and ~~the~~have ~~approved~~an ~~claims~~uncertain ~~that~~outcome. Further, we may ~~make~~encounter ~~for~~substantial ~~the~~delays ~~products;~~in our clinical trials.

~~limitations~~The orclinical ~~warnings~~trials ~~contained~~and manufacturing of IMG-007 and any future product candidates are subject to extensive and rigorous review and regulation by numerous government authorities in the ~~product’s~~United ~~FDA~~States and in other countries where we intend to test and market IMG-~~approved~~007 ~~labeling~~and orany ~~those~~future ofproduct ~~comparable~~candidates. ~~foreign~~Before obtaining regulatory ~~authorities,~~approvals ~~including~~for ~~potential~~the ~~limitations~~commercial sale of any of IMG-007 or ~~warnings~~any ~~for~~future ~~our~~product ~~current~~candidates, we must demonstrate through lengthy, complex and expensive preclinical testing and clinical trials that such product candidates are both safe and ~~any~~effective for use in each target indication. In particular, because IMG-007 is subject to regulation as a biological drug product, we will need to demonstrate that it is safe, pure and potent for use in its target indications. IMG-007 and each future product candidates ~~that~~must ~~may~~demonstrate bean ~~more~~adequate ~~restrictive~~risk ~~than~~versus ~~other~~benefit ~~competitive~~profile ~~products;~~in its intended patient population and for its intended use.

changes in the standard of care for the targeted indications for our current product candidates and any future product candidates, which could reduce the marketing impact of any claims that we could make following FDA approval or approval by comparable foreign regulatory authorities, if obtained;

the relative convenience and ease of administration of our current product candidates and any future product candidates and any products with which they are co-administered;

the cost of treatment compared with the economic and clinical benefit of alternative treatments or therapies;

the availability of adequate coverage or reimbursement by third party payors, including government healthcare programs such as Medicare and Medicaid and other healthcare payors;

the price concessions required by third-party payors to obtain coverage;

the willingness of patients to pay out-of-pocket in the absence of adequate coverage and reimbursement;

the extent and strength of our marketing and distribution of our current product candidates and any future product candidates;

the safety, efficacy, and other potential advantages over, and availability of, alternative treatments already used or that may later be approved;

distribution and use restrictions imposed by the FDA or comparable foreign regulatory authorities with respect to our current product candidates and any future product candidates or to which we agree as part of a REMS or voluntary risk management plan;

the timing of market introduction of our current product candidates and any future product candidates, as well as competitive products;

our ability to offer our current product candidates and any future product candidates for sale at competitive prices;

the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

~~the~~Table ~~extent and strength~~ of ~~our third-party manufacturer and supplier support;~~ Contents

~~the~~Clinical ~~actions~~testing ofis ~~companies~~expensive ~~that~~and ~~market~~takes many years to complete, and is subject to uncertainty. Our planned clinical trials may not be conducted as planned or completed on schedule, if at all. Delays and failures can occur at any ~~products~~time ~~with~~during ~~which~~the clinical trial process. Even if our ~~current~~future ~~product~~clinical ~~candidates~~trials are completed as planned, their results may not support the safety and effectiveness of IMG-007 or any future product candidates for their targeted indications or support continued clinical development of such product candidates. Our future clinical trial results may not be ~~co-administered;~~ successful.

In addition, even if our planned trials are successfully completed, the FDA or comparable foreign regulatory authorities may not interpret the results as we do, and more trials could be required before we submit IMG-007 or any future product candidates for approval. To the extent that the results of ~~other~~the ~~new~~trials ~~products;~~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 IMG-007 or any future product candidates.

~~adverse~~To ~~publicity~~date, ~~about~~we have not completed any pivotal clinical trials required for the approval of IMG-007. We may experience delays in conducting any clinical trials, and we do not know whether our ~~current~~clinical ~~product~~trials ~~candidates~~will begin on time, will need to be redesigned, will recruit and ~~any~~enroll ~~future~~patients ~~product~~on ~~candidates~~time or ~~any~~have ~~products~~data ~~with~~readouts ~~which~~or ~~they~~be ~~are~~completed ~~co-administered~~on schedule, or ~~favorable~~at ~~publicity~~all. ~~about~~Events ~~competitive~~that ~~products;~~may prevent successful or timely commencement, readouts, and completion of clinical development and preclinical studies include:

•

~~potential~~inability ~~product~~to ~~liability~~generate ~~claims.~~sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials;

•

~~There~~delays isin ~~significant~~sufficiently ~~uncertainty related to the insurance coverage and reimbursement of newly approved products. In the United States~~developing, ~~the~~characterizing ~~principal~~or ~~decisions~~controlling ~~about reimbursement by government authorities for new products are typically made by CMS, since CMS decides whether and to what extent~~ a ~~new~~manufacturing ~~product~~process ~~will~~suitable ~~be covered and reimbursed under Medicare. Private payers tend to follow CMS to a substantial degree. However, one payer’s determination to provide coverage~~ for aadvanced ~~product~~clinical ~~does not assure that other payers will also provide coverage for the drug product. Further~~trials, aor ~~payer’s~~failure ~~decision~~ to ~~provide~~do coverage for a drug product does not imply that the payor will provide adequate reimbursement. Reimbursement agencies in the EU may be more conservative than CMS. Factors payors consider in determining reimbursement are based on whether the product is:so;

•

adelays ~~covered~~in ~~benefit~~reaching ~~under~~agreement ~~its~~with ~~health~~the ~~plan~~FDA, or other comparable foreign regulatory authorities as to the design or implementation of our clinical trials, or failure to do so;

•

~~safe,~~delays ~~effective~~in ~~and~~or ~~medically~~failure ~~necessary~~to obtain regulatory approval to commence a clinical trial;

•

~~appropriate~~delays ~~for~~in or failure to reach an agreement on acceptable terms with clinical trial sites or prospective CROs the ~~specific~~terms ~~patient~~of which can be subject to extensive negotiation and may vary significantly among different clinical trial sites;

•

~~cost-effective;~~delays ~~and~~in or failure to obtain IRB approval or positive ethics committee opinion at each site;

•

~~neither~~delays ~~experimental~~in ~~nor~~or ~~investigational.~~failure to recruit suitable patients to participate in a clinical trial;

•

~~Additionally,~~delays ~~net~~in ~~prices for drugs may be reduced by mandatory discounts~~ or ~~rebates~~failure required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. We cannot be sure that reimbursement will be available for any product candidate that we develop and commercialize and, if reimbursement is available, the level of reimbursement. In addition, many pharmaceutical manufacturers must calculate and report certain price reporting metrics to ~~the~~have ~~government,~~patients ~~such~~complete asa ~~average~~clinical ~~sales~~trial ~~price~~or ~~and~~return ~~best price. Penalties may apply in some cases when such metrics are not submitted accurately and timely. Further, these prices~~ for ~~drugs~~post-treatment ~~may be reduced by mandatory discounts or rebates required by government healthcare programs.~~follow-up;

•

Inclinical ~~addition~~sites, inCROs ~~some~~or ~~foreign~~other ~~countries,~~third ~~the~~parties ~~proposed~~deviating ~~pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely~~ from ~~country~~trial toprotocol country. For example, the EU provides options for its Member States to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. To obtain reimbursement or ~~pricing~~dropping ~~approval,~~out ~~some~~ of ~~these countries may require the completion of clinical trials that compare the cost effectiveness of~~ a particular product candidate to currently available therapies. A Member State may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our product candidates. Historically, products launched in the EU do not follow price structures of the U.S. and generally prices tend to be significantly lower.trial;

•

~~Risks~~failure ~~Related~~ to ~~Our~~perform ~~Reliance~~in onaccordance ~~Third~~with ~~Parties~~the FDA’s GCP requirements, or applicable regulatory guidelines in other countries;

•

Wedelays ~~rely,~~or ~~and~~failure ~~expect~~due to ~~continue~~restrictions toor ~~rely,~~other onmandated ~~third~~requirements ~~parties~~imposed toby ~~conduct~~FDA ~~our~~or ~~clinical~~other ~~trials~~regulatory asbodies ~~well~~on asthe ~~investigator-sponsored~~conduct ~~clinical trials~~ of ~~our~~the ~~product~~clinical ~~candidates.~~development Ifprogram ~~these~~based ~~third~~on ~~parties~~either dointernal ~~not~~or ~~successfully~~external ~~carry~~data, ~~out~~such ~~their~~as ~~contractual~~emerging ~~duties,~~data ~~comply~~ with ~~regulatory~~other ~~requirements or meet expected deadlines~~molecules, weeither ~~may~~in ~~not~~development ~~be able to obtain regulatory approval for~~ or ~~commercialize~~approved, ~~our~~that ~~product~~target ~~candidates~~the ~~and~~same ~~our~~immunological ~~business~~pathway ~~could~~as ~~be substantially harmed.~~ IMG-007;

•

Wethe doserious, ~~not~~life-threatening ~~have~~diseases of the ~~ability~~patients toenrolled ~~independently~~in ~~conduct~~our clinical trials., Wewho ~~rely~~may ~~and~~die ~~expect~~or tosuffer ~~continue~~adverse tomedical ~~rely~~events onduring ~~medical~~the ~~institutions,~~course ~~clinical~~of ~~investigators,~~the ~~contract~~trials ~~laboratories~~for ~~and~~reasons ~~other~~that ~~third~~may ~~parties,~~not ~~such~~be asrelated ~~CROs,~~ to ~~conduct~~IMG-007 or ~~otherwise~~any ~~support~~future ~~clinical trials for our~~ product candidates.;

•

failure in addressing patient safety concerns that arise during the course of a trial, including occurrence of adverse events associated with IMG-007 or any future product candidate that are viewed to outweigh its potential benefits;

•

failure to add a sufficient number of clinical trial sites; or

•

failure to manufacture sufficient quantities of IMG-007 or any future product candidates for use in clinical trials.

WeTable ~~rely and expect to continue to rely heavily on these parties for execution~~ of clinical trials for our product candidates and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol, legal and regulatory requirements, and scientific standards, and our reliance on CROs will not relieve us of our regulatory responsibilities. For any violations of laws and regulations during the conduct of our clinical trials, we could be subject to warning letters or enforcement action that may include civil penalties up to and including criminal prosecution.Contents

We, ~~our~~may ~~principal~~experience ~~investigators~~numerous ~~and~~unforeseen ~~our~~events ~~CROs are required to comply with regulations~~during, ~~including~~or ~~GCPs~~as ~~for~~a ~~conducting,~~result ~~monitoring~~of, ~~recording, and reporting the results of~~ clinical trials ~~to ensure~~ that ~~the~~could ~~data~~delay and results are scientifically credible and accurate, and that the trial patients are adequately informed of the potential risks of participating in clinical trials and their rights are protected. These regulations are enforced by the FDA, the Competent Authorities of the Member States of the EEA and comparable foreign regulatory authorities for any products in clinical development. The FDA enforces GCP regulations through periodic inspections of clinical trial sponsors, principal investigators, and trial sites. If we, our principal investigators or ~~our~~prevent ~~CROs fail to comply with applicable GCPs, the clinical data generated in~~ our ~~clinical~~ability ~~trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us~~ to ~~perform~~receive ~~additional clinical trials before approving our~~ marketing ~~applications.~~approval Weor ~~cannot~~commercialize ~~assure~~IMG-007 ~~that,~~or ~~upon inspection, the FDA will determine that~~ any ~~of our~~ future ~~clinical trials will comply with GCPs. In addition, our clinical trials must be conducted with~~ product candidates ~~produced in accordance with cGMP regulations. Our failure~~ or ~~the failure of our principal investigators or CROs to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process,~~ significantly increase ~~our expenditures and could also subject us to enforcement action. We also are required to register ongoing clinical trials and post~~ the ~~results~~cost of ~~completed~~such ~~clinical~~ trials ~~on a government-sponsored database~~, ~~ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.~~ including:

•

~~Although~~ we ~~designed~~may ~~clinical~~experience ~~trials,~~changes ~~these~~in ~~trials~~regulatory ~~are~~requirements ~~conducted~~or ~~by CROs and we expect CROs will conduct all of our future clinical trials. As a result~~guidance, ~~many~~or ~~important~~receive ~~aspects~~feedback offrom ~~our~~regulatory ~~development~~authorities ~~programs,~~that ifrequires ~~pursued,~~us ~~including their conduct and timing, are outside of our direct control. Our reliance on third parties~~ to ~~conduct~~modify ~~future clinical trials also results in less direct control over~~ the ~~management~~design of ~~data~~our ~~developed through~~ clinical trials than would be the case if we were relying entirely upon our own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Outside parties may: ;

•

~~have~~clinical ~~staffing~~trials ~~difficulties;~~of IMG-007 or any future product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon development programs;

•

~~fail~~the tonumber ~~comply~~of ~~with~~patients ~~contractual~~required ~~obligations;~~for clinical trials of IMG-007 or any future product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;

•

~~experience~~the ~~regulatory~~ability ~~compliance~~to ~~issues;~~monitor patients adequately during or after treatment;

•

~~undergo~~our ~~changes~~third-party incontractors ~~priorities~~may fail to comply with regulatory requirements or ~~become~~meet ~~financially~~their ~~distressed;~~contractual obligations to us in a timely manner, or at all;

•

~~form~~we ~~relationships~~or our investigators might have to suspend or terminate clinical trials of IMG-007 or any future product candidates for various reasons, including non-compliance with regulatory requirements, a finding that IMG-007 or any future product candidates have undesirable side effects or other ~~entities~~unexpected characteristics, ~~some~~a offinding ~~which~~that ~~may~~the beparticipants ~~our~~are ~~competitors.~~being exposed to unacceptable health risks;

•

~~These~~adverse ~~factors~~events ~~may~~suffered ~~materially~~by ~~adversely affect the willingness or ability of third parties to conduct our~~ clinical ~~trials~~trial ~~and~~participants ~~may subject us to unexpected cost increases~~ that are beyond our control. If the principal investigators or CROs do not perform clinical trials in a satisfactory manner, breach their obligations to us, or fail to comply with regulatory requirements, the development, regulatory approval and commercialization of our product candidates may beultimately ~~delayed, we may not~~ be ~~able~~determined to ~~obtain regulatory approval and commercialize our product candidates or our development programs may~~ be ~~materially~~unrelated ~~and irreversibly harmed. If we are unable~~ to ~~rely~~IMG-007 ~~on clinical data collected by our principal investigators~~ or ~~CROs, we could be required to repeat, extend the duration of, or increase the size of~~ any ~~clinical~~future ~~trials~~product ~~we conduct and this could significantly delay commercialization and require significantly greater expenditures.~~ candidates;

•

If any of our relationships with these third-party principal investigators or CROs terminate, we may not be able to enter into arrangements with alternative CROs. If principal investigators or CROs do not successfully carry out their contractual obligations or meet expected deadlines, if they need to be replaced or if the ~~quality~~cost ~~or accuracy~~ of ~~the~~ clinical ~~data~~trials ~~they~~of ~~obtain~~IMG-007 ~~is compromised due to the failure to adhere to our clinical protocols, regulatory requirements~~ or ~~for other reasons,~~ any ~~clinical~~future ~~trials~~product ~~such~~candidates ~~principal investigators or CROs are associated with~~ may be ~~extended,~~greater ~~delayed~~than orwe ~~terminated,~~anticipate and we may elect not ~~be able~~ to ~~obtain~~cover ~~regulatory approval for, or successfully commercialize, our product candidates. As a result, we believe that our financial results and~~ the ~~commercial prospects for our product candidates in the subject indication would be harmed, our~~ costs ~~could increase and our ability to generate revenue could be delayed.~~ ;

•

~~We may also rely on academic and private non-academic institutions to conduct and sponsor clinical trials relating to our product candidates. We will not control~~ the ~~design~~supply or ~~conduct~~quality of ~~the investigator~~IMG-~~sponsored~~007 ~~trials,~~or ~~and~~any itfuture isproduct ~~possible~~candidates ~~that the FDA~~ or ~~non-U.S.~~other ~~regulatory~~materials ~~authorities~~necessary ~~will~~to ~~not~~conduct ~~view these investigator-sponsored trials as providing adequate support for future~~ clinical trials, ~~whether~~of ~~controlled~~IMG-007 ~~by us~~ or ~~third parties, for~~ any ~~one~~future orproduct ~~more~~candidates ~~reasons,~~may ~~including~~be ~~elements~~insufficient ~~of the design~~ or ~~execution of the trials or safety concerns or other trial results.~~ inadequate;

•

regulators may revise the requirements for approving IMG-007 or any future product candidates, or such requirements may not be as we anticipate; and

•

any future collaborators that conduct clinical trials may face any of the above issues, and may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us.

If we are required to conduct additional clinical trials or other testing of IMG-007 or any future product candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of IMG-007 or any future product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:

•

incur unplanned costs;

•

be delayed in obtaining marketing approval for IMG-007 or any future product candidates or not obtain marketing approval at all;

•

obtain marketing approval in some countries and not in others;

•

obtain marketing approval for indications or patient populations that are not as broad as intended or desired;

•

obtain marketing approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

•

be subject to additional post-marketing testing requirements; or

•

have the product removed from the market after obtaining marketing approval.

We could encounter delays if a clinical trial is suspended or terminated by us, by the IRBs or ethics committees of the institutions in which such trials are being conducted, by the Data Safety Monitoring Board (“DSMB”) for such trial or by the FDA or comparable foreign regulatory authorities. These authorities may impose such a suspension or

~~Such~~Table arrangements will likely provide us certain information rights with respect to the investigator-sponsored trials, including access to and the ability to use and reference the data, including for our own regulatory filings, resulting from the investigator-sponsored trials. However, we would not have control over the timing and reporting of the data from investigator-sponsored trials, nor would we own the data from the investigator-sponsored trials. If we are unable to confirm or replicate the results from the investigator-sponsored trials or if negative results are obtained, we would likely be further delayed or prevented from advancing further clinical development of our product candidates. Further, if investigators or institutions breach their obligations with respect to the clinical development of our product candidates, or if the data proves to be inadequate compared to the first-hand knowledge we might have gained had the investigator-sponsored trials been sponsored and conducted by us, then our ability to design and conduct any future clinical trials ourselves may be adversely affected.Contents

Wetermination ~~have~~due ~~entered~~to ~~into~~a ~~collaborations~~number ~~and~~of ~~may~~factors, ~~enter~~including ~~into~~failure ~~additional~~to ~~collaborations~~conduct the clinical trial in ~~the~~accordance ~~future~~with regulatory requirements or our clinical protocols, ~~and~~inspection weof ~~might~~the ~~not~~clinical ~~realize~~trial operations or trial site by the ~~anticipated~~FDA ~~benefits~~or comparable foreign regulatory authorities resulting in the imposition of ~~such~~a ~~collaborations.~~clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

~~Research,~~IMG-007 will require extensive clinical testing before we are prepared to submit a biologics license application (“BLA”) or marketing authorization application (“MAA”) for regulatory approval. We cannot predict with any certainty if or when we might complete the clinical development for IMG-007 or any future product candidates and submit a BLA or MAA for regulatory approval of IMG-007 or any future product candidates or whether any such BLA or MAA will be approved. We may also seek feedback from the FDA, ~~commercialization~~or other comparable foreign regulatory authorities on our clinical development program, and/ the FDA or ~~strategic~~such ~~collaborations~~other ~~are~~comparable ~~subject~~foreign toregulatory ~~numerous~~authorities ~~risks~~may not provide such feedback on a timely basis, or such feedback may not be favorable, which ~~include~~could ~~the~~further ~~following:~~delay our development of IMG-007 or any future product candidates.

~~collaborators~~We ~~may~~also ~~have~~cannot ~~significant~~predict ~~control~~with any certainty whether or ~~discretion~~when we might complete a given clinical trial. If we experience delays in ~~determining~~the commencement or completion of our clinical trials, or if we terminate a clinical trial prior to completion, the ~~efforts~~commercial ~~and~~prospects ~~resources~~of ~~that~~IMG-007 ~~they~~or ~~will~~any ~~apply~~future product candidates could be harmed, and our ability to agenerate ~~collaboration~~revenues from IMG-007 or any future product candidates may be delayed. In addition, any delays in our clinical trials could increase our costs, slow down the development and ~~might~~approval ~~not~~process ~~commit~~and ~~sufficient~~jeopardize ~~efforts~~our ability to commence product sales and ~~resources~~generate orrevenues. ~~might~~Any ~~misapply~~of ~~those~~these ~~efforts~~occurrences may harm our business, financial condition and ~~resources;~~results of operations. In addition, many 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 IMG-007 or any future product candidates.

weIMG-007 or any future product candidates may cause serious adverse events (“SAEs”) or undesirable side effects or have ~~limited~~other ~~influence~~properties that may delay or ~~control~~prevent ~~over~~regulatory ~~the~~approval, ~~approaches~~cause us to ~~research,~~suspend ~~development~~or discontinue clinical trials, ~~and/or~~limit ~~commercialization~~the commercial profile of ~~product~~an ~~candidates~~approved inlabel, ~~the~~or ~~territories~~result in ~~which~~significant ~~our~~negative ~~collaboration~~consequences ~~partners~~following ~~lead~~marketing ~~research~~approval, ~~development~~if ~~and/or commercialization;~~ any.

~~collaborators~~Manipulation ~~might~~of ~~not~~the ~~pursue~~immune ~~research,~~system ~~development,~~via ~~and/or~~therapeutic ~~commercialization~~agents can result in a spectrum of ~~collaboration~~immunosuppression ~~product~~depending ~~candidates~~on orthe ~~might~~target ~~elect~~and ~~not~~the todisease ~~continue~~being ortreated. ~~renew~~In ~~research,~~general ~~development~~terms ~~and/or~~immunosuppression ~~commercialization~~has ~~programs~~been ~~based~~associated onwith ~~nonclinical~~increased risk of infection and~~/or~~, ~~clinical~~with ~~trial~~long ~~results~~term immunosuppression, ~~changes~~malignancies. inThe ~~their~~risk ~~strategic~~of ~~focus,~~these ~~availability~~types of ~~funding~~events oris ~~other~~dependent ~~factors,~~both ~~such~~on the breadth of immunosuppression as awell ~~business~~as ~~combination~~the ~~that~~disease ~~diverts~~and ~~resources~~population orin ~~creates~~which ~~competing~~it ~~priorities;~~is being used.

~~collaborators~~As ~~might~~with ~~delay,~~all ~~provide~~protein-based ~~insufficient~~therapies ~~resources~~administered ~~to,~~either intravenously or ~~modify~~subcutaneously orthere ~~stop~~is ~~research~~also orthe ~~clinical~~risk ~~development~~of ~~for~~injection ~~collaboration~~site ~~product~~reactions ~~candidates~~and orsystemic ~~require~~hypersensitivity areactions, ~~new~~with ~~formulation~~cases of aanaphylaxis ~~product~~reported ~~candidate~~with ~~for~~some ~~clinical~~such ~~testing;~~agents. The incidence and severity of these reactions vary depending on the characteristics of both the therapeutic agent, its target, and the vehicle solution in which the therapy is administered.

~~collaborators~~When ~~with~~considering ~~sales~~other therapies that target the OX40-OX40L pathway, ~~marketing~~infections including serious infections, injection site reactions, chills and ~~distribution~~pyrexia, ~~rights~~hypersensitivity toreactions, ~~one~~oral orand ~~more~~gastrointestinal ~~product~~ulceration, ~~candidates~~and ~~might~~malignancies ~~not~~including ~~commit~~Kaposi ~~sufficient~~Sarcoma ~~resources~~have tobeen ~~sales~~reported. To date, ~~marketing~~a ~~and~~causal ~~distribution~~association orbetween ~~might~~the ~~otherwise~~therapies ~~fail~~targeting tothe ~~successfully~~pathway ~~commercialize~~and ~~those~~the ~~product~~events ~~candidates;~~has not been established.

~~collaborators~~There ~~might~~may ~~not~~be ~~properly~~undesirable ~~maintain~~side effects and adverse events associated with IMG-007 or ~~defend~~any ~~our~~future ~~intellectual~~product ~~property~~candidates. ~~rights~~Undesirable side effects or ~~might~~adverse ~~use~~events ~~our~~that ~~intellectual~~may ~~property~~be ~~improperly~~caused by IMG-007 or any future product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a ~~way~~more ~~that~~restrictive ~~jeopardizes~~label ~~our~~than ~~intellectual~~anticipated ~~property~~or the delay or ~~exposes~~denial usof toregulatory ~~potential~~approval ~~liability;~~by the FDA or comparable foreign regulatory authorities. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.

~~collaboration~~While ~~activities~~the ~~might~~data ~~result~~reported into ~~the~~date ~~collaborator~~from ~~having~~our ~~intellectual~~Phase ~~property~~1 ~~covering~~and ~~our~~Phase ~~activities~~2a orclinical ~~product~~trials ~~candidates~~indicate that IMG-007 was generally well tolerated, ~~which~~there remains a risk that clinical trial results could ~~limit~~reveal high and unacceptable severity and prevalence of previously unreported side effects or unexpected characteristics. Any such findings could cause delays in completion or cancellation of our ~~rights~~clinical trials or ~~ability~~require us to ~~research,~~abandon ~~develop and/~~or ~~commercialize~~limit our ~~product~~development ~~candidates;~~of IMG-007.

collaborators might not be in compliance with laws applicable to their activities under the collaboration, which could impact the collaboration and us;

disputes might arise between a collaborator and us that could cause a delay or termination of the collaboration or result in costly litigation that diverts management attention and resources; and

collaborations might be terminated, which could result in a need for additional capital to pursue further research, development, and/or commercialization of our product candidates.

In addition, funding provided by a collaborator might not be sufficient to advance product candidates under the collaboration.

If a collaborator terminates a collaboration or a program under a collaboration, including by failing to exercise a licens

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