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 ~~June~~December 3031, ~~2024~~2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ~~FOR THE TRANSITION PERIOD FROM TO~~

FOR THE TRANSITION PERIOD FROM TO

Commission File Number 001-40608

ESTRELLA IMMUNOPHARMA, INC.

(Exact name of Registrant as specified in its Charter)

Delaware		86-1314502
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

5858 Horton Street, Suite 370 Emeryville, California		94608
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (510) 318-9098

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

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	ESLA	The Nasdaq Stock Market LLC
Warrants, each warrant exercisable for one share of Common Stock, each at an exercise price of $11.50 per share	ESLAW	The Nasdaq Stock Market LLC

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.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☒

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 and non-voting common equity held by non-affiliates of the Registrant, based on the closing price of $1.0125 per share of the Registrant’s common ~~stock~~ stock on the Nasdaq Stock Market LLC on ~~July~~March 112, ~~2024~~2026, was $4020,~~271~~496,~~957~~203.

The number of Registrant’s shares of common stock outstanding as of ~~September~~March 2012, ~~2024~~2026 was 3642,~~190~~665,~~896~~228.

Documents incorporated by reference

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

TABLE OF CONTENTS

Page PART I 1 Item 1. Business 1 Item 1A. Risk Factors 5527 Item 1B. Unresolved Staff Comments ~~122~~86 Item 1C. Cybersecurity ~~123~~86 Item 2. Properties ~~123~~87 Item 3. Legal Proceedings ~~123~~87 Item 4. Mine Safety Disclosures ~~123~~87 PART II ~~124~~88 Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities ~~124~~88 Item 6. [Reserved] ~~127~~88 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations ~~128~~89 Item 7A. Quantitative and Qualitative Disclosures About Market Risk ~~137~~93 Item 8. Financial Statements and Supplementary Data ~~137~~94 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure ~~137~~94 Item 9A. Controls and Procedures ~~137~~94 Item 9B. Other Information ~~138~~95 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections ~~138~~95 PART III ~~139~~96 Item 10. Directors, Executive Officers and Corporate Governance ~~139~~96 Item 11. Executive Compensation ~~139~~96 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters ~~139~~96 Item 13. Certain Relationships and Related Transactions, and Director Independence ~~139~~96 Item 14. Principal Accounting Fees and Services ~~139~~96 PART IV ~~140~~97 Item 15. Exhibits, and Financial Statement Schedules ~~140~~97 Item 16. Form 10-K Summary ~~144~~101

Estrella MARKET AND INDUSTRY DATA

This Annual Report includes estimates regarding market and industry data and forecasts, which are based on our own estimates utilizing our management’s knowledge of and experience in, as well as information obtained from our subscribers, trade and business organizations, and other contacts in the market sectors in which we compete, and from statistical information obtained from publicly available information, industry publications and surveys, reports from government agencies, and reports by market research firms. We confirm that, where such information is reproduced herein, such information has been accurately reproduced and that, so far as we are aware and are able to ascertain from information published by publicly available sources and other publications, no facts have been omitted that would render the reproduced information inaccurate or misleading. Industry publications, reports, and other published data generally state that the information contained therein has been obtained from sources believed to be reliable, but we cannot assure you that the information contained in these reports, and therefore the information contained in this Annual Report that is derived therefrom, is accurate or complete. Our estimates of our market position may prove to be inaccurate because of the method by which we obtain some of the data for our estimates or because this information cannot always be verified with complete certainty due to the limits on the availability and reliability of raw data, the voluntary nature of the data gathering process, and other limitations and uncertainties. As a result, although we believe our sources are reliable, we have not independently verified the information and cannot guarantee its accuracy and completeness.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report contains forward-looking statements. All statements other than statements of historical facts contained in this Annual Report are forward-looking statements. This includes, without limitation, statements regarding our vision and business strategy, including the plans and objectives of management for our future operations; our market opportunities, our future revenue opportunities, performance of our partnerships, and our future performance and financial condition. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this Annual Report, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “expected to,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this Annual Report, including, but not limited to:

●

the projected financial information, anticipated growth rate, and market opportunities of Estrella;

●

the ability to maintain the listing of the Common Stock on Nasdaq;

●

Estrella’s public securities’ potential liquidity and trading;

●

Estrella’s ability to raise financing in the future;

●

Estrella’s success in retaining or recruiting, or changes required in, officers, key employees, or directors;

●

potential effects of extensive government regulation;

●

Estrella’s future financial performance and capital requirements;

●

the impact of supply chain disruptions;

●

high inflation rates and interest rate increases;

● the impact of the 2022 Russian invasion of Ukraine, ~~and~~ 2023 Israel/Hamas conflict and the 2026 armed conflict between the United States/Israel and Iran;

●

the impact of pandemics, including on preclinical studies and potential future clinical trials; and

●

factors relating to the business, operations, and financial performance of Estrella, including:

●

Estrella’s ability to operate as a standalone company;

●

the initiation, cost, timing, progress, and results of research and development activities, preclinical studies, or clinical trials with respect to Estrella’s current and potential future product candidates;

●

Estrella’s ability to advance research on EB103 and its use in conjunction with CF33-CD19t;

●

Estrella’s ability to identify, develop, and commercialize product candidates;

●

Estrella’s ability to advance its current and potential future product candidates into, and successfully complete, preclinical studies and clinical trials;

●

Estrella’s or Eureka’s ability to obtain and maintain regulatory approval of Estrella’s current and potential future product candidates, and any related restrictions, limitations, and/or warnings in the label of an approved product candidate;

●

Estrella’s ability to obtain funding for its operations;

●

Estrella’s and Eureka’s ability to obtain, maintain and enforce intellectual property protection for their technologies and product candidates;

●

Estrella’s ability to successfully commercialize its current and any potential future product candidates;

●

the rate and degree of market acceptance of Estrella’s current and any potential future product candidates;

●

regulatory developments in the United States and international jurisdictions;

●

Estrella’s and Eureka’s ability to attract and retain key scientific and management personnel;

●

Estrella’s ability to effectively manage the growth of its operations;

●

Estrella’s ability to maintain its current licenses and contractual arrangements with Eureka;

●

potential liability lawsuits and penalties related to Estrella’s licensed or acquired technologies, product candidates, and current and future relationships with third parties;

●

Estrella’s ability to continue to contract with third-party suppliers and manufacturers and their ability to perform adequately under those arrangements; and

●

Estrella’s ability to compete effectively with existing competitors and new market entrants.

These forward-looking statements are based on information available as of the date of this Annual Report and current expectations, forecasts, and assumptions, and involve a number of judgments, risks, and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we do not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities laws. We intend the forward-looking statements contained in this Annual Report to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, or the “Securities Act”, and Section 21E of the Securities Exchange Act of 1934, as amended, or the “Exchange Act”.

As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. You should not place undue reliance on these forward-looking statements.

iii

SUMMARY RISK FACTORS

Our business is subject to numerous risks and uncertainties, including those highlighted in the section entitled “Risk Factors” in this Annual Report, that represent challenges that we face in connection with the successful implementation of our strategy and the growth of our business. In particular, the following considerations, among others, may offset our competitive strengths, or have a negative effect on our business strategy, which could cause a decline in the price of shares of our Common Stock or Warrants and result in a loss of all or a portion of your investment:

●Risks ~~We are a clinical stage biotechnology company and expect~~ Related to ~~incur~~Our ~~significant~~Financial ~~losses~~Condition ~~for the foreseeable future~~ and ~~may~~Capital ~~never achieve or maintain profitability.~~Requirements

● ~~Our~~We ~~ability~~are toa ~~continue~~clinical-stage asbiotechnology company with a ~~going~~limited ~~concern~~operating ~~requires~~history ~~that~~and wea ~~obtain~~history ~~sufficient~~of ~~funding~~significant net losses. We expect to ~~finance~~incur ~~our~~significant ~~operations~~losses for the foreseeable future and may never achieve or maintain profitability.

● ~~Our~~We ~~current~~will orneed ~~potential~~substantial ~~future~~additional funding to advance our product candidates ~~may~~and ~~not~~support ~~demonstrate~~our ~~the~~operations. ~~safety~~As of December 31, ~~purity~~2025, orwe ~~efficacy~~had ~~necessary~~approximately to$1.4 ~~become~~million ~~approvable~~in orcash ~~commercially~~and ~~viable~~cash equivalents.

● ~~Although~~Our werecurring ~~intend~~losses toand ~~explore~~need ~~other~~for ~~therapeutic~~additional ~~opportunities~~financing inraise ~~addition~~substantial doubt about our ability to ~~the~~continue ~~product~~as ~~candidates~~a going concern. If we are ~~currently~~unable ~~pursuing~~to obtain sufficient funding, we may ~~fail~~be forced to ~~identify~~delay, ~~viable~~reduce, ~~new~~or ~~product~~eliminate ~~candidates~~our ~~for~~product ~~clinical~~ development, ~~which~~programs ~~could~~or ~~materially~~liquidate ~~harm~~ our ~~business~~assets.

●Risks ~~Clinical~~Related to ~~development~~the ~~includes~~Development ~~a lengthy~~ and ~~expensive~~Commercialization ~~process with an uncertain outcome, and results~~ of ~~earlier~~Our ~~studies~~Product ~~and trials may not be predictive of future trial results.~~Candidates

● WeOur ~~rely~~success ondepends ~~third~~heavily ~~parties to conduct our preclinical studies, and plan to rely~~ on ~~third~~the ~~parties~~successful ~~to conduct~~ clinical ~~trials,~~development and those third parties may not perform satisfactorily. If third parties on which we intend to rely to conduct certain preclinical and clinical studies do not perform as contractually required, fail to satisfy regulatory orapproval ~~legal~~of ~~requirements~~our orlead ~~miss~~product ~~expected deadlines~~candidate, ~~our development program could be delayed or unsuccessful~~EB103, and weour ~~may~~ability ~~not be able~~ to ~~obtain~~expand ~~regulatory approval for or commercialize~~ our ~~product~~pipeline ~~candidates~~using ~~when~~the ~~expected,~~ARTEMIS® ~~or at all~~platform.

● WeClinical ~~may~~trials ~~not~~are beexpensive, ~~able~~time-consuming, difficult to ~~maintain~~design, ~~our~~and ~~existing~~involve ~~strategic~~uncertain ~~partnerships~~outcomes. ~~and~~We ~~collaboration~~may ~~arrangements~~experience ordelays ~~enter~~in ~~into~~enrolling ~~new~~patients, ~~strategic~~serious ~~partnerships~~adverse ~~and~~events ~~collaborations~~(such ~~for~~as ~~the~~those ~~development,~~observed ~~manufacturing,~~in ~~and~~similar ~~commercialization~~therapies), ofor ~~product~~failures ~~candidates~~to ondemonstrate ~~terms~~safety ~~that~~and ~~are~~efficacy, ~~acceptable~~which tocould ~~us,~~prevent orregulatory ~~at all~~approval.

● ~~The~~Interim, ~~manufacturing~~topline, ofand ~~our~~preliminary ~~product~~data ~~candidates~~from isour ~~complex.~~clinical Iftrials ~~Eureka,~~may orchange ~~other~~as ~~third~~more ~~parties,~~data ~~encounter~~becomes ~~difficulties~~available inand ~~production,~~are ~~our~~subject ~~ability~~ to ~~supply~~audit ~~our~~and ~~product~~verification ~~candidates~~procedures ~~for~~that ~~clinical~~could ~~trials~~result ~~or,~~in ifmaterial ~~approved,~~changes ~~for~~in ~~commercial~~the ~~sale,~~final ~~could be delayed or halted entirely~~data.

● WeEven ~~face~~if ~~competition~~we ~~from~~obtain ~~companies~~regulatory ~~that~~approval, ~~have~~our ~~developed~~products or may ~~develop~~face ~~product~~significant ~~candidates~~competition ~~for~~from ~~the~~larger ~~treatment~~pharmaceutical ofcompanies, ~~the diseases that we~~ may ~~target,~~fail ~~including~~to ~~companies~~achieve ~~developing~~market ~~novel therapies and platform technologies. If these companies develop platform technologies or product candidates more rapidly than we do~~acceptance, or ifmay ~~their~~be ~~platform~~subject ~~technologies or product candidates are more effective or have fewer side effects, our ability~~ to ~~develop~~unfavorable pricing and ~~successfully~~reimbursement ~~commercialize product candidates may be adversely affected~~policies.

Risks Related to Our Relationship with Eureka Therapeutics and Third Parties

●

We are a “controlled company” within the meaning of Nasdaq rules, as Eureka Therapeutics, Inc. holds more than 50% of our voting power. This concentration of ownership may limit other stockholders’ ability to influence corporate matters.

● ~~Our~~We ~~future~~are ~~success~~heavily ~~depends~~dependent on Eureka for our ~~ability~~manufacturing ~~and~~(as ~~Eureka’s~~our ~~ability~~sole tosupplier ~~retain~~of ~~key~~clinical ~~employees,~~drug ~~directors~~product), research and ~~advisors~~development support, and toinformation ~~attract,~~technology ~~retain,~~systems ~~and~~under ~~motivate~~a ~~qualified~~Services ~~personnel~~Agreement. Termination or disruption of these services would severely impact our operations.

● ~~Our~~Certain ~~business,~~of ~~operations,~~our ~~and~~officers ~~clinical development plans~~ and ~~timelines could be adversely affected by the ongoing COVID-19 pandemic~~directors, including ~~business~~our ~~interruptions~~CEO, ~~staffing~~have ~~shortages~~actual ~~and~~or ~~supply~~potential ~~chain~~conflicts ~~issues~~of ~~arising~~interest ~~from~~due ~~the~~to ~~pandemic~~their ondual ~~the~~roles ~~manufacturing, clinical trial, and other business activities performed by us~~ or byequity ~~third~~interests ~~parties~~in ~~with whom we may conduct business, including our anticipated contract manufacturers, contract research organizations (“CROs”), suppliers, shippers, and others~~Eureka.

● ~~The~~We ~~anticipated~~rely ~~benefits~~on ofthird ~~the~~parties, ~~Separation~~including ~~may~~Contract ~~not~~Research beOrganizations ~~achieved~~(CROs) and collaborators like Imugene, to conduct our preclinical studies and clinical trials. Their failure to perform satisfactorily could delay our development timelines.

●Risks ~~If we are unable~~ Related to ~~obtain~~Intellectual or protect intellectual property rights related to our in-licensed technology, future technologies, and current or future product candidates, or if our intellectual property rights are inadequate, our competitors could develop and commercialize products and technology similar or identical to ours, and we may not be able to compete effectively in our market or successfully commercialize any product candidates we may develop.Property

● WeOur ~~may~~success bedepends ~~unable~~on toour ~~obtain~~ability ~~U.S.~~to ~~or foreign regulatory approval and~~obtain, ~~as a result~~maintain, beand ~~unable~~enforce tointellectual ~~commercialize~~property ~~our~~rights, ~~current~~many orof ~~potential~~which ~~future~~are ~~product~~in-licensed ~~candidates~~from Eureka.

● ~~Even~~We ifmay webe ~~are~~involved ~~able~~in lawsuits to ~~commercialize~~protect ~~any~~or ~~product~~enforce ~~candidate,~~our ~~such~~patents ~~product~~or ~~candidate~~be ~~may become~~ subject to ~~unfavorable~~claims ~~pricing~~that ~~regulations~~we orinfringe ~~third-party~~on ~~coverage~~the ~~and~~intellectual ~~reimbursement~~property ~~policies~~rights of others, which ~~would~~could ~~harm~~be ~~our~~expensive ~~business~~and time-consuming.

● WeChanges orin ~~the~~patent ~~third~~law ~~parties~~or wethe ~~depend~~inability onto ~~may~~protect beour ~~adversely~~trade ~~affected~~secrets bycould ~~natural~~diminish ~~disasters,~~the ~~including~~value ~~earthquake,~~of ~~flood,~~our ~~fire,~~proprietary ~~explosion, extreme weather conditions, or epidemics~~technology.

●Risks ~~If any negative data were~~ Related to ~~arise~~Regulatory ~~with~~and ~~respect~~Legal to the use of our licensed technology in territories where such technology is licensed to a third party, it could negatively affect our ability to develop our product candidates in territories where we license such technology.Compliance

●

The regulatory approval process in the U.S. and foreign jurisdictions is lengthy and unpredictable. We may encounter delays or rejections based on FDA feedback or changes in regulatory policy.

●

We handle sensitive personal data and are subject to stringent data privacy laws (such as GDPR, CCPA, and HIPAA). Failure to comply could result in significant fines and reputational harm.

●

We are subject to healthcare fraud and abuse laws, anti-corruption laws (FCPA), and other regulations; non-compliance could result in severe penalties.

Risks Related to Our Common Stock and Internal Controls

●

We have identified material weaknesses in our internal control over financial reporting related to a lack of qualified accounting personnel. If not remediated, this could affect the reliability of our consolidated financial statements.

●

We have a history of non-compliance with Nasdaq listing standards, including minimum bid price and market value requirements. Failure to maintain compliance could result in the delisting of our Common Stock.

●

The market price of our Common Stock is likely to be highly volatile, and future sales of shares could result in substantial dilution to existing stockholders.

PART I

In this Annual Report, unless the context otherwise requires, references to “we,” “us,” “our,” “Estrella,” or the “Company” refer to Estrella Biopharma, Inc. as a private company before September 29, 2023, and, on and after September 29, 2023, refer to Estrella Immunopharma, Inc. and, where appropriate, Estrella Biopharma, Inc. as a wholly-owned subsidiary of Estrella Immunopharma, Inc. prior to Estrella Biopharma, Inc. merging with and into Estrella Immunopharma, Inc. on June 30, 2024.

Item 1. Business.

Overview

We are a clinical-stage biopharmaceutical company developing T-cell therapies ~~with the capacity~~ to address treatment challenges for patients with cancers and autoimmune diseases. ~~The~~Our ~~Company~~strategy ~~was~~is to ~~originally~~harness ~~incorporated~~the asevolutionary ~~Estrella~~power ~~Biopharma,~~of ~~Inc. in~~ the ~~State~~human ofimmune ~~Delaware~~system ~~on March~~to ~~30,~~provide ~~2022,~~patients bywith ~~Eureka~~potentially ~~Therapeutics~~safer, ~~Inc.~~more ~~(“Eureka”),~~efficacious which was established in California in February 2006 and reincorporated in Delaware in March 2018. On June 28, 2022, Estrella entered into a Contribution Agreement with Eureka, under which Eureka contributed certain assets related to T-cell therapies ~~targeting CD19 and CD22 proteins in exchange for 105,000,000 shares of Estrella’s Series~~ AAcompared ~~Preferred~~to ~~Stock~~traditional ~~(the~~CAR-T ~~“Separation”)~~therapies. ~~This~~Leveraging ~~Separation~~cutting-edge ~~included~~cellular ~~Estrella~~engineering ~~entering into a License Agreement with Eureka and Eureka Therapeutics (Cayman) Ltd.~~technologies, ~~granting~~we ~~Estrella~~aim ~~an exclusive license~~ to ~~develop~~overcome ~~CD19~~the ~~and~~limitations of ~~CD22~~current ~~targeted T~~CAR-~~cell~~T therapies ~~using Eureka’s ARTEMIS® platform. Additionally~~, ~~Estrella~~such ~~assumed~~as ~~the~~high ~~Collaboration~~toxicity ~~Agreement between Eureka~~ and ~~Imugene~~prohibitive ~~Limited~~costs, ~~which~~so ~~covers~~that ~~the development~~T-cell oftherapy ~~solid tumor~~ treatments ~~using~~can ~~Imugene’s~~be ~~CF33-CD19t~~accessible into ~~conjunction~~a ~~with~~larger patient ~~Estrella’s EB103 therapy~~population.

~~On September~~Lead ~~29,~~Program 2023, Estrella consummated a business combination (the “Business Combination”) with TradeUP Acquisition Corp. (“UPTD”), a blank-check company, pursuant to the Agreement and Plan of Merger dated September 30, 2022 (the “Merger Agreement”). Under the terms of the Merger Agreement, Tradeup Merger Sub Inc., a wholly-owned subsidiary of UPTD, merged with and into Estrella, resulting in Estrella becoming a wholly-owned subsidiary of UPTD. Following the closing of the business combination, UPTD was renamed Estrella Immunopharma, Inc. On June 26, 2024, Estrella Immunopharma, Inc. filed a Certificate of Ownership and Merger with the Delaware Secretary of State to effect a merger with its wholly-owned subsidiary, Estrella Biopharma, Inc. under Section 253 of the Delaware General Corporation Law. This merger, effective at 11:59 PM Eastern Time on June 30, 2024, was approved by the unanimous written consent of the Company’s board of directors. As a result of the merger, the separate existence of Estrella ceased, and Estrella Immunopharma, Inc. became the surviving corporation, assuming all assets, liabilities, and obligations of Estrella.Status

~~We believe~~Our innovative ARTEMIS® T~~-cell~~ ~~therapy~~Cell ~~continues~~Receptor toPlatform ~~represent~~uniquely adesigns ~~revolutionary~~T ~~step~~cells ~~towards~~that, ~~providing~~unlike a ~~potential~~traditional ~~solution~~CAR-T ~~for~~cell, ~~many~~are ~~forms~~activated ofand ~~cancer,~~regulated ~~including~~upon engagement with ~~cancers~~cancer ~~poorly~~targets ~~addressed~~using bycellular ~~current~~mechanisms ~~approaches.~~more ~~Existing~~resembling ~~chimeric~~those ~~antigen~~from ~~receptor~~the endogenous T-cell, orreceptor ~~CAR-T,~~(TCR). ~~therapies~~Our lead product candidate, EB103, ~~the~~is ~~initial~~a ~~class~~CD19-directed of ARTEMIS T-cell ~~therapies,~~therapy ~~have~~designed ~~demonstrated~~to ~~remarkable~~address ~~efficacy~~the ~~and~~unmet ~~significant~~medical ~~survival~~needs ~~benefit~~of inpatients ~~certain~~with ~~CD19-positive~~relapsed ~~blood~~or ~~cancers~~refractory ~~like~~B-cell ~~lymphomas~~malignancies, ~~and~~especially ~~leukemias~~those who are not eligible for currently approved T-cell therapies. ~~CD19~~EB103 is currently in the dose expansion portion of a ~~protein~~Phase ~~expressed~~I/II onclinical ~~the~~trial ~~surface~~(STARLIGHT-1) ofin ~~almost~~patients ~~all~~with relapsed/refractory B-cell ~~leukemias~~Non-Hodgkin’s ~~and lymphomas~~Lymphomas. ~~Current~~As ~~CAR-T cell~~of ~~therapies,~~December ~~however~~2025, we have ~~limitations~~completed ~~that~~the ~~may~~second ~~preclude~~dose ~~broad~~cohort ~~adoption,~~in ~~including~~the ~~potentially~~Phase ~~life~~I dose-~~threatening~~escalation ~~side~~portion ~~effects~~of ~~like~~our ~~the~~STARLIGHT-1 ~~hypersecretion~~Phase I/II clinical trial of ~~inflammatory~~EB103, ~~cytokines~~and ~~known~~an asindependent ~~Cytokine~~Data ~~Release~~Safety ~~Syndrome~~Monitoring Board (~~“CRS”~~DSMB) ~~and~~has ~~immune~~completed ~~effector~~its ~~cell-associated~~review ~~neurotoxicity~~of ~~syndrome (“ICANS”).~~safety ~~This~~data ~~side~~from ~~effect,~~the ~~however,~~Phase isI ~~considered~~dose-escalation phase ~~addressable~~(n=9) ~~with~~and ~~other~~recommended ~~treatment~~advancing ifthe trial into the ~~net~~Phase ~~effect~~II isexpansion tophase ~~target~~at ~~and~~the ~~kill cancer~~recommended ~~cells~~Phase inII ~~the~~dose ~~body~~(RP2D). ~~Additionally,~~In ~~CAR~~the Phase I dose-Tescalation ~~therapies~~phase, ~~target~~no ~~and~~treatment-related ~~kill~~serious ~~all~~adverse ~~cells~~events ~~expressing~~were ~~CD19~~reported, ~~(including~~and ~~healthy~~the Bhigh-~~cells).~~dose ~~These side~~cohort ~~effects~~achieved ~~have~~a ~~limited~~100% ~~currently~~complete response ~~approved~~rate ~~CAR-T~~at ~~therapies~~Month to1 ~~specialized~~in ~~cancer~~all ~~centers~~evaluable ~~and~~patients, ~~later~~a ~~lines~~majority of ~~treatment~~whom ~~for~~were ~~patients that~~considered ~~have~~high-risk ~~undergone~~and ~~other~~ineligible ~~types~~for ofcurrently ~~treatment~~available commercial ~~unsuccessfully~~CD19 products.

~~Our mission~~Additional isProduct to harness the evolutionary power of the human immune system to transform the lives of patients fighting cancer and autoimmune disease with safe, effective therapies. To accomplish this mission, our lead product candidate, EB103, which is a T-cell therapy we also call “CD19-Redirected ARTEMIS® T-Cell Therapy,” utilizes Eureka’s ARTEMIS® technology to target CD19. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS® T-Cell, like EB103 T-cells, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from the endogenous T-cell receptor (TCR). EB103 is currently undergoing a Phase I/II clinical trial (STARLIGHT-1) to assess safety and determine the Recommended Phase II Dose (RP2D) in patients with relapsed/refractory B-cell Non-Hodgkin’s Lymphomas. As of September 2024, two patients have been treated in the STARLIGHT-1 clinical trial.Candidates

We are also developing EB104, which aare T-~~cell~~cells ~~therapy~~that weutilize ~~also call “CD19/22 Dual-Targeting~~ ARTEMIS® ~~T-Cell Therapy.” Like EB103, EB104 utilizes Eureka’s ARTEMIS®~~ technology to target not only CD19, but also CD22,. aLike ~~protein that, like~~ CD19, CD22 is expressed on the surface of most B-cell malignancies. EB104’s dual-targeting strategy has the potential to more effectively treat patients with lower surface CD19 density or a greater prevalence of CD22, ~~and~~thus ~~reduce~~potentially reducing relapse due to CD19 antigen loss.

Solid tumors represent approximately 90% of all cancers. To date, T-cell therapy such as CAR-T has demonstrated limited success treating solid tumors. One major barrier limiting the potential of T-cell therapy is the lack of tumor-specific targets. We believe that, in collaboration with Imugene and Imugene’s product candidate, CF33-CD19t, an oncolytic virus, EB103 T-cells have the potential to overcome this barrier using a “mark and kill” strategy. This “mark and kill” strategy entails using CF33-CD19t, to induce solid tumor cells into expressing the CD19 protein on the cell surface. Our EB103 T-cells can then pursue and kill the now CD19-expressing solid tumor cells, offering a potential treatment to cancers that lack solid tumor-specific targets.1

1Solid tumors represent approximately 90% of all cancers. To date, T-cell therapy such as CAR-T has demonstrated limited success in treating solid tumors. One major barrier limiting the potential of T-cell therapy is the lack of tumor-specific targets. We believe that, in collaboration with Imugene and Imugene’s product candidate, CF33-CD19t, an oncolytic virus, EB103 T-cells have the potential to overcome this barrier using a “mark and kill” strategy. This “mark and kill” strategy entails using CF33-CD19t, to induce solid tumor cells into expressing the CD19 protein on the cell surface. Our EB103 T-cells can then pursue and kill the solid tumor cells expressing exogenous CD19, offering a potential treatment to cancers that lack solid tumor-specific targets.

~~Hematological Cancers~~Corporate History

~~Hematological cancers,~~On orJune ~~blood cancers~~28, ~~are cancers that begin in blood-forming tissue~~2022, ~~such~~pursuant asto ~~the bone marrow, or in the cells of the body’s immune system. Examples of hematologic cancers are leukemia, lymphoma, and multiple myeloma. Leukemia is~~ a ~~broad~~Contribution ~~term~~Agreement ~~for~~between ~~cancers~~Estrella ~~of the blood cells. The type of leukemia depends on the type of blood cell that becomes cancer~~ and ~~whether it grows quickly or slowly. Leukemia occurs most often in adults older than 55~~Eureka, ~~but~~Eureka itcontributed ~~is also the most common cancer in children younger than 15. The National Cancer Institute~~certain ~~estimates~~assets ~~that~~related ~~there~~to ~~will be over 60,000 new cases of leukemia in the United States in 2022, representing approximately 3.2% of all new cancer cases. B~~T-cell ~~lymphoma~~therapies istargeting aCD19 ~~type~~and ofCD22 ~~cancer that forms~~ in ~~B-cells~~exchange (afor ~~type of immune system cell). B-cell lymphomas may be either indolent (slow-growing) or aggressive (fast-growing). Non-Hodgkin lymphoma (NHL) has an incidence rate of 19.0 per 100~~105,000,000 ~~per~~shares ~~year and B-cell lymphomas make up most (about 85%)~~ of ~~NHL~~Estrella’s inSeries ~~the~~AA ~~United States. There are many different types of B-cell non-Hodgkin lymphomas.~~Preferred ~~These~~Stock ~~include Burkitt lymphoma~~ (BL“Separation”), ~~chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL).~~

TOn September 29, 2023, Estrella completed a business combination (the “Business Combination”) with TradeUP Acquisition Corp. (“UPTD”), a blank-~~cell~~check ~~Therapies~~company, under the terms of the Agreement and Plan of Merger dated September 30, 2022. Following the merger, Estrella became a wholly owned subsidiary of UPTD, and UPTD was renamed Estrella Immunopharma, Inc.

~~The field~~On ofJune ~~immunotherapy~~26, ~~has evolved rapidly over the past few decades~~2024, ~~and we believe that we are positioned to build upon previous research~~Estrella toImmunopharma, ~~harness~~Inc. ~~the~~merged ~~potential~~with ofits ~~immunotherapy~~wholly toowned ~~drive~~subsidiary, ~~significant~~Estrella ~~advances~~Biopharma, ~~in cancer treatment~~Inc., ~~T-cells~~under ~~are~~Section ~~white~~253 ~~blood~~of ~~cells in~~ the ~~body’s immune~~Delaware ~~system~~General ~~that fight infections and tumor cells~~Corporation Law. ~~T-cells~~The ~~also~~merger, ~~act~~effective ~~to signal other immune cells to respond to threats. T-cells are ideally suited for immuno-oncology applications based~~ on ~~several~~June ~~characteristics.~~30, ~~T-cells~~2024, ~~recognize~~was ~~their~~approved ~~targets~~by ~~because they are created in a way that allows them to specifically recognize foreign antigens on~~ the ~~surface~~Board of ~~other~~Directors ~~cells. T-cells are extremely specific, able to recognize a cancer cell~~ and ~~kill~~resulted ~~it,~~in ~~while~~Estrella ~~ignoring an almost identical healthy cell. However~~Immunopharma, ~~tumor cells sometimes evolve to escape killing by T-cells by activating a number of pathways that suppress T-cell function~~Inc. ~~The goal with T-cell immunotherapy is to reprogram~~assuming aall ~~patient’s~~assets, ~~own~~liabilities, ~~T-cells so that the T-cells can seek out~~ and ~~destroy~~obligations ~~cancer~~of ~~cells~~Estrella ~~wherever they are hiding in the body~~Biopharma, ~~despite normal tumor suppressive mechanisms~~Inc. On ~~T-cell~~November ~~therapy~~27, ~~is also referred to as T-cell transfer therapy~~2024, ~~adoptive~~the ~~cell~~Company ~~therapy,~~established ~~adoptive~~a ~~immunotherapy~~wholly owned ~~and~~subsidiary ~~immune~~in ~~cell~~Hong ~~therapy~~Kong.

~~T-cell therapies~~Our involve collecting a patient’s own T-cells, growing large numbers of these T-cells in a lab, and then giving the cells back to the patient through a needle in the patient’s vein. During the process of growing a patient’s T-cells in a lab environment, a patient may have treatment with chemotherapy and, maybe, radiation therapy to eliminate other immune cells, as reducing the patient’s immune cells can help the transferred T-cells to be more effective.Strategy

~~One type~~Key elements of ~~T-cell~~our ~~therapy for treating cancer, CAR-T cell therapy, uses T-cells reprogrammed to express chimeric antigen receptors (CAR)~~business ~~directed~~strategy ~~at a certain target (“CAR-T cells”), allowing the CAR-T cells to attach to specific proteins on the surface of cancer cells, improving their ability to attack the cancer cells.~~include:

2● Effectively progress EB103, our lead product candidate, through clinical development. We believe our autologous T-cell therapies have the potential to overcome major limitations of currently approved CAR-T cells with superior safety and efficacy, allowing access to significantly more patients. As of December 2025, we have completed the dosing of nine patients in the Phase I dose escalation phase of STARLIGHT-1 and have initiated Phase II dose expansion phase at the RP2D. We anticipate completing the Phase II portion of the STARLIGHT-1 clinical trial in 1H2027.

~~CAR~~● Expand Total Addressable Market (TAM) in CD19-positive cancers through the demonstration of safety and efficacy of ARTEMIS T ~~THERAPY~~-cell ~~PROCESS~~in clinical settings for patients not eligible for currently approved T-cell therapies: EB103’s safety profile positions it for potential use in earlier-line treatments, broader adoption in community hospital settings rather than being restricted to specialized medical centers, and the ability to treat high-risk patient groups, thereby increasing market penetration and patient accessibility.

~~History and~~● ~~Development~~Advance our second product candidate, EB104, into clinical development. We are compiling an Investigational New Drug (IND) filing for EB104 for the treatment of Trelapsed/refractory and high-risk B cell ~~Therapies~~malignancies. Phase I trials may not commence until the FDA has approved the Investigational New Drug (“IND”) Application for EB104.

~~Over the~~● ~~past~~Explore 20the ~~years,~~use ~~using~~of ~~T-cells~~EB103 toin ~~treat~~conjunction ~~cancer has moved from a radical ideal to clinical reality,~~ with ~~the~~CF33-CD19t ~~first~~for ~~major~~multiple ~~successes~~indications ~~occurring around~~of ~~2010,~~solid ~~when~~tumors ~~small~~through clinical ~~trials produced dramatically positive results in fighting aggressive blood cancers~~development. ~~The~~If ~~first T-cell trials were conducted in~~ the ~~mid-1990s~~Phase ~~targeting~~I/II ~~HIV CAR~~Starlight-T1 ~~cells~~Clinical —Trial ~~the~~is ~~initial class of T-cell therapy. The effects of these first trials to fight HIV were mild, but the effort ended with the creation of~~ successful ~~HIV drug cocktails and~~, ~~importantly,~~we ~~revealed~~plan ~~that CAR-T-cells survived for more than 17 years in patients following treatment. In the mid-2000s, clinical trials using CAR-T-cells~~ to ~~treat solid~~submit ~~tumors~~an ~~were~~IND ~~largely~~filing ~~unsuccessful. A few years later, trials~~ for ~~CAR-T-cells that targeted a surface protein called CD19, which is found only on~~ the ~~immune~~use ~~system’s B cells and mutate to cause certain types~~ of ~~leukemia~~EB103 ~~and lymphoma, showed positive results~~ in ~~three~~conjunction ~~patients~~ with ~~leukemia.~~CF33-CD19t ~~Those trials, however, also had the unexpected result of triggering CRS,~~ in ~~which~~ the ~~reengineered T-cells trigger the release of inflammatory signaling molecules called cytokines, causing severe fever, nausea, fatigue and body aches that can be life-threatening~~future. ~~Over~~At ~~the~~this ~~past decade~~time, ~~clinicians~~we ~~developed~~have ~~strategies~~not todetermined ~~treat~~ the ~~side~~solid ~~effects~~tumor ofindications ~~T-cell therapies. Still, because of risks associated with CRS and ICANS, nearly all T-cell therapies~~ to ~~treat~~target ~~cancer~~or ~~must~~an beexact ~~administered~~timeframe atfor ~~dedicated~~filing ~~cancer~~our ~~centers~~IND application.

The data that accumulated in the mid-2010s from trials by pharmaceutical companies Novartis and Kite Pharma was compelling, and in 2017, the FDA approved Novartis’ Kymriah™ for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy and Kite Pharma’s Yescarta™ for patients with large-B-cell lymphomas whose cancer had progressed after receiving at least two prior treatment regimens. Since 2017, four additional CAR-T therapies have been approved by the FDA.2

3● Continue to innovate to develop and advance a novel T-cell therapy pipeline. We are committed to developing more disruptive therapies that have the potential to be adopted in earlier lines of treatment and to be delivered in community outpatient settings, as well as treat patients in diverse indications beyond cancer, such as autoimmune diseases.

~~Limitations on~~Our ~~T-cell~~Pipeline ~~Therapies~~of Clinical Programs

~~The approvals~~We ofintend ~~CAR-T~~to ~~therapies~~initially ~~over~~focus on ~~the~~advancing ~~past~~our ~~five~~CD19-Redirected ~~years~~ARTEMIS ~~demonstrate the viability of~~ T~~-cell~~ ~~therapies~~Cell asprograms ain ~~new~~relapsed/refractory ~~class~~and ofhigh-risk ~~cancer~~blood ~~immunotherapies~~cancers. ~~Analogous~~ ~~to the advent of monoclonal antibodies~~Meanwhile, we ~~believe~~are ~~that T-cell therapies have the potential to become some of the most impactful~~advancing ~~cancer~~a ~~immunotherapy~~robust ~~products~~pipeline ~~over~~for ~~the~~other ~~next~~hematologic ~~decade~~malignancies, ~~but~~solid ~~will~~tumor ~~first~~and ~~need~~autoimmune todisease. ~~overcome~~Our ~~certain~~commitment ~~limitations~~to ~~that~~safety, ~~have~~accessibility, ~~constrained widespread~~and ~~use~~cost-effectiveness ~~over~~positions ~~the~~us ~~past~~to ~~five~~redefine ~~years. In particular, we believe~~ the ~~existing classes of commercially approved~~ T-cell ~~therapies~~therapy ~~may~~paradigm beand ~~unable to~~deliver ~~realize~~transformative ~~their~~solutions ~~full~~to ~~potential~~more ~~due~~patients. toThe ~~the~~ following chart ~~limitations~~summarizes our clinical programs:

●Our ~~Hyperactivation~~Therapeutic of T-Cells Resulting in Severe Toxicities. The uncontrolled activation of T-cells can lead to CRS. Currently marketed CAR-T therapies include a boxed warning citing fatal or life-threatening risks of CRS and ICANS. We believe these severe toxicity risks will likely limit the incorporation of these therapies into earlier lines of therapy and their adoption in community outpatient settings.Focus

●Our ~~High~~primary ~~Costs~~focus ~~and~~is ~~Consequences~~on ofdeveloping innovative ~~Toxicities.~~therapies ~~CRS~~for ~~and~~CD19-positive ~~ICANS~~cancers, ~~are~~a ~~very costly side effects to manage. The risk of these occurrences results in standard treatment protocols that can add~~ significant ~~indirect~~subset ~~costs on top~~ of ~~direct~~hematologic ~~reimbursement~~malignancies ~~costs~~with ~~and~~high ~~are~~unmet ~~burdensome~~medical ~~to patients and the healthcare system overall~~needs. ~~Experimental~~Currently approved clinical strategies aimed at mitigating these risks include utilization of restrictive enrollment screening criteria to reduce the potential for CAR-T related toxicities. Such screening tactics would decrease the number of patients eligible for these therapies, ~~and~~such ~~could~~as ~~also~~Kymriah® ~~increase~~(Novartis) ~~the overall burden~~ and ~~cost~~Yescarta® of(Kite ~~treatment. Currently~~Pharma), ~~the~~have ~~average~~demonstrated ~~cost~~efficacy ofin ~~standard~~relapsed ~~CAR-T~~or refractory B-cell ~~treatment~~malignancies ~~plans~~but isface ~~approximately~~limitations ~~$400,000.~~due to:

● ~~Challenges~~Severe inToxicities: ~~the~~High ~~Treatment~~rates of ~~Solid~~Cytokine ~~Tumor~~Release ~~Cancers.~~Syndrome ~~Due~~(CRS) toand ~~its~~immune ~~ability~~effector ~~to target cancer-specific intracellular antigens, the currently preferred T-~~cell ~~therapy platform to target solid tumors is engineered T~~-~~Cell~~associated ~~Receptor~~neurotoxicity ~~T-cells,~~syndrome ~~or TCR-T. However, TCR-T therapies face the following challenges:~~ (iICANS) ~~T-cell receptors~~, oroften ~~TCRs,~~requiring ~~have~~hospitalization ~~a suboptimal affinity for their target antigens; (ii) enhancing TCRs’ affinity for therapeutic purposes can introduce off-target toxicity;~~ and ~~(iii)~~intensive ~~engineered TCRs can mis-pair with endogenous TCRs, leading to cross-reactivity with unknown consequences~~management.

~~We believe~~● ~~that~~High ~~EB103~~Costs: ~~and~~Complex ~~EB104 have the potential to overcome these limitations through providing a more selective immune response, limiting tertiary costs associated with side effects of treatment,~~ and ~~attacking~~individualized ~~solid~~manufacturing ~~tumors~~processes ~~with~~that aresult ~~“mark~~in ~~and~~significant ~~kill”~~financial ~~strategy~~burdens.

~~Emerging opportunities~~● inRestricted ~~expanding~~Access: ~~the~~Limited ~~curative~~availability ~~capacity~~in ofspecialized ~~T-cell~~tertiary ~~therapy~~care ~~to autoimmune diseases~~centers.

Autoimmune diseases occur when the immune system, which normally defends the body against harmful invaders, mistakenly attacks healthy tissues. These diseases can affect various organs, leading to chronic inflammation, tissue damage, and in some cases, life-threatening complications. Common examples include systemic lupus erythematosus (SLE), rheumatoid arthritis, and multiple sclerosis. The cause is often an overactive immune response, particularly involving autoreactive B cells that produce antibodies targeting the body’s own tissues.3

~~Traditional~~Our ~~treatments~~Approach: ~~for~~EB103 ~~autoimmune~~aims ~~diseases~~to ~~have~~address ~~focused~~these onchallenges ~~controlling~~by ~~symptoms~~enhancing ~~and slowing disease progression. B-cell depletion therapies~~safety, ~~such~~ ~~as CD20-targeting antibodies (e.g.~~scalability, ~~Rituximab, Ocrelizumab)~~ and ~~BAFF inhibitors (e~~accessibility.~~g.,~~ ~~Belimumab),~~Its ~~have~~excellent ~~provided~~safety profile ~~some~~allows ~~relief~~ for ~~conditions~~ ~~like~~broader ~~lupus~~patient ~~and~~eligibility, ~~multiple~~including ~~sclerosis.~~individuals ~~These~~with ~~therapies~~comorbidities ~~aim~~or toadvanced ~~reduce~~age ~~the~~and ~~number~~potentially ~~of autoreactive B cells. However, they have limitations.~~expands ~~Most~~treatment ~~existing~~access ~~treatments~~to ~~only~~community ~~manage symptoms and are rarely curative~~settings. ~~Long-term~~Our ~~administration~~streamlined isproduction ~~often~~process ~~required,~~also ~~and~~enables ~~patients~~us ~~may~~to ~~experience serious~~lower ~~side effects, while~~ the ~~underlying~~cost ~~disease~~of ~~continues to progress or return~~manufacturing.

~~We believe~~Opportunities ~~CD19-redirected~~for ~~T-cell~~Increasing ~~therapy~~Total ~~offers~~Accessible Market a(TAM) ~~promising~~for ~~new~~Blood ~~approach~~Cancers towith ~~treating~~a ~~autoimmune diseases. In recent clinical studies, CD19~~Best-~~redirected CAR T~~in-~~cell~~Class therapy has shown the potential to go beyond symptom management by depleting the entire population of autoreactive B cells, leading to rapid and durable disease remission. A notable study in lupus patients demonstrated that a single dose of CD19~~-targeting~~ ~~CAR~~ T-~~cells~~cell ~~resulted in significant improvements, with most patients entering remission and experiencing long-lasting benefits.~~Therapy

~~We are~~Hematological expanding our clinical investigation of our CD19-redirected ARTEMIS T-cell therapy into autoimmune diseases. Our EB201 program, in preclinical development, is being explored as a potential therapeutic approach targeting Systemic Lupus Erythematosus (SLE).Cancers

4Hematological cancers, or blood cancers, are cancers that begin in blood-forming tissues, such as the bone marrow, or in the body’s immune cells. Examples of hematologic cancers are leukemia, lymphoma, and multiple myeloma. Leukemia is a broad term for cancers of the blood cells. The type of leukemia depends on the type of blood cell that becomes cancerous and whether it grows quickly or slowly. The National Cancer Institute (NCI) estimates 66,890 new cases of leukemia in the United States in 2025, representing approximately 3.3% of all new cancer cases. B-cell lymphoma is a type of cancer that forms in B-cells (a type of immune system cell). B-cell lymphomas may be either indolent (slow-growing) or aggressive (fast-growing). NCI estimates 80,350 new cases of non-Hodgkin lymphoma (NHL) in 2025, and B-cell lymphomas make up most (about 85%) of NHL in the United States. There are many different types of B-cell non-Hodgkin lymphomas. These include Burkitt lymphoma (BL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL).

~~ARTEMIS® Cell~~Limitations ~~Receptor~~of ~~Platform~~Currently Approved T-cell Therapies

~~Eureka has~~The ~~granted~~approvals usof anCAR-T ~~exclusive~~therapies over ~~license~~the ~~relating~~recent toyears ~~targeted~~demonstrate the viability of T-cell therapies, ~~which~~as wea ~~are~~new ~~developing,~~class inof ~~the~~cancer ~~Licensed Territory~~immunotherapies. WeAnalogous ~~are using~~to ~~Eureka’s~~the ~~ARTEMIS® (Antibody Redirected T-Cells with Endogenous Modular~~advent ~~Immune~~of ~~Signaling)~~monoclonal ~~platform~~antibodies, ~~technology~~we tobelieve ~~develop~~that ~~such targeted~~ T-cell therapies. ~~The~~have ~~ARTEMIS®~~the ~~platform~~potential ~~builds on~~to ~~successes~~become some of ~~current~~the ~~CAR-T~~most ~~therapies~~impactful bycancer ~~using~~immunotherapy products ~~T-cells~~over ~~engineered~~the tonext ~~use~~decade, abut ~~cellular~~will ~~mechanism~~first ~~more~~need ~~closely~~to ~~resembling~~overcome ~~one~~certain ~~from~~limitations anthat ~~endogenous T-cell~~have ~~receptor,~~constrained ~~producing~~widespread ~~a more natural and restrained immune response.~~use:

~~The key~~● ~~units~~Hyperactivation of ~~ARTEMIS®~~ T-~~cells~~Cells ~~comprise~~Resulting ofin anSevere ~~antibody-T-cell-receptor (AbTCR) and a co-stimulatory molecule~~Toxicities. The ~~AbTCR serves~~uncontrolled asactivation ~~the~~of ~~core component featuring a target~~T-~~binding~~cells ~~domain~~can ~~derived~~lead ~~from~~to anCRS. ~~antibody~~Currently ~~fragment~~marketed ~~antigen~~CAR-~~binding~~T ~~(Fab)~~therapies ~~region~~include ~~and an effector domain derived from portions of~~ a ~~human~~boxed ~~gamma/delta~~warning ~~(γδ)~~citing ~~TCR.~~fatal ~~Given~~or ~~that~~life-threatening ~~the~~risks ~~AbTCR includes portions~~ of aCRS ~~human TCR, the AbTCR by its nature associates with the endogenous CD3 complex. This enables the AbTCR to use the same activation~~ and ~~regulatory pathways employed by natural TCRs~~ICANS. ~~The~~We ~~co-stimulatory~~believe ~~molecule~~these issevere antoxicity ~~additional~~risks ~~key~~will ~~component~~likely ~~featuring~~limit athe ~~target-binding~~incorporation ~~domain~~of ~~derived from~~these atherapies ~~single-chain~~into ~~variable~~earlier ~~fragment~~lines ~~(scFv)~~of therapy and ~~co-stimulatory~~their ~~domain~~adoption ~~derived~~in ~~from~~community ~~portions~~outpatient ~~of a human co-stimulatory receptor~~settings.

~~Preclinical Data~~● High Costs and Consequences of Toxicities. CRS and ICANS are very costly side effects to manage. The risk of these occurrences results in standard treatment protocols that can add significant indirect costs on top of direct reimbursement costs and are burdensome to patients and the healthcare system overall. Currently, the average cost of standard CAR-T cell treatment plans is approximately $400,000.

~~In preclinical~~● ~~data~~Challenges ~~from~~in ~~Eureka’s~~the ~~2018~~Treatment ~~paper~~of ~~published~~Solid inTumor ~~Cell~~Cancers. ~~Discovery~~Due ~~(the~~to ~~“2018~~its ~~Paper”),~~ability ~~ARTEMIS® T~~to target cancer-~~cells~~specific ~~expressing~~intracellular anantigens, ~~AbTCR~~the ~~construct~~currently ~~targeting~~preferred ~~CD19~~T-cell ~~functionally~~therapy ~~matched~~platform ~~the~~to ~~potency~~target ofsolid ~~CAR-~~tumors is engineered T-Cell Receptor T-cells, ~~but~~or ~~released~~TCR-T. ~~lower~~However, ~~levels of~~TCR-T ~~cytokines~~therapies ~~upon~~face the ~~killing~~following ofchallenges: ~~target~~(i) T-~~positive~~cell ~~cells~~receptors, inor ~~both~~TCRs, inhave ~~vitro~~a ~~and~~suboptimal ~~tumor~~affinity ~~xenograft~~for ~~mouse~~their ~~models.~~target ~~The~~antigens; ~~2018~~(ii) ~~Paper~~enhancing ~~explored~~TCRs’ ~~ARTEMIS® T-cells~~affinity ~~expressing~~for ~~only~~therapeutic ~~the~~purposes ~~AbTCR~~can ~~receptor,~~introduce asoff-target ~~the~~toxicity; ~~co-stimulatory~~and ~~molecule~~(iii) ~~was~~engineered ~~added~~TCRs ~~(and~~can ~~the~~mis-pair ~~current~~with ~~form~~endogenous ofTCRs, ~~EB103~~leading ~~was~~to ~~created) in~~cross-reactivity ~~late~~with ~~2018~~unknown consequences.

~~Eureka conducted~~According to Grand View Research, the ~~study~~global atCAR ~~Children’s~~T-cell ~~Hospital~~therapy ofmarket ~~Philadelphia~~size ~~(CHOP)~~was estimated at $5.82 billion in 2025 and ~~Lumigenics~~is ~~(Richmond,~~projected ~~CA)~~to ~~using~~reach ~~female~~$22.36 ~~NSG~~billion ~~mice~~by ~~aged~~2033, ~~eight~~growing toat ~~ten~~a ~~weeks~~compounded annual growth rate of 18.06% Tofrom ~~compare~~2026 ~~the~~to ~~phenotypes~~2033. ~~between~~However, ~~AbTCR-T~~currently ~~cells~~only ~~and~~about 20% of eligible patients are treated by current CAR-T ~~cells~~therapies, ~~Eureka~~due ~~engineered~~to atheir ~~single-chain~~various ~~variable~~limitations ~~fragment~~described above. We believe that EB103 and EB104 programs have the potential to ~~fused~~overcome itthese ~~with~~limitations aand ~~widely-used~~capture ~~CAR~~the ~~T-cell~~vast ~~(also~~majority ~~called~~of untapped TAM through providing a ~~“second~~more ~~generation”~~selective ~~CAR~~immune ~~T-cell).~~response, ~~This~~limiting tertiary ~~allowed~~costs ~~Eureka~~associated towith ~~evaluate~~side ~~AbTCR-T cells~~effects inof ~~comparison~~treatment, toand anattacking ~~existing~~solid ~~CAR-T~~tumors ~~platform~~with ~~that~~a is“mark ~~widely~~and ~~used~~kill” ~~clinically~~strategy.

During T-cell manufacturing, AbTCR-T cells expanded with similar growth kinetics as the CAR T-cells and yielded T-cell populations with similar transduction efficiencies and the composition of CD4+ T-cells and CD8+ T-cells, which are subsets of T-cells, which is a well-accepted metric for evaluating the subsets of manufactured T-cells.4

~~(a)~~Emerging ~~AbTCR~~opportunities ~~and~~in ~~CAR~~expanding ~~T- were cultured and~~ the curative ~~number~~capacity of ~~cells~~T-cell ~~determined~~therapy atto ~~the~~autoimmune ~~indicated time points.~~diseases

Autoimmune diseases occur when the immune system, which normally defends the body against harmful invaders, mistakenly attacks healthy tissues. These diseases can affect various organs, leading to chronic inflammation, tissue damage, and in some cases, life-threatening complications. Common examples include systemic lupus erythematosus (bSLE), ~~Proportions~~rheumatoid ofarthritis, ~~CD4/CD8~~and ~~within~~multiple ~~receptor+~~sclerosis. The cause is often an overactive immune response, particularly involving autoreactive B cells that produce antibodies targeting the body’s own tissues.

5Traditional treatments for autoimmune diseases have focused on controlling symptoms and slowing disease progression. B-cell depletion therapies, such as CD20-targeting antibodies (e.g., Rituximab, Ocrelizumab) and BAFF inhibitors (e.g., Belimumab), have provided some relief for conditions like lupus and multiple sclerosis. These therapies aim to reduce the number of autoreactive B cells. However, most existing treatments only manage symptoms and are rarely curative. Long-term administration is often required, and patients may experience serious side effects, while the underlying disease continues to progress or return.

~~Retrospective analysis~~We ~~from~~believe ~~published CAR~~CD19-redirected T-cell ~~clinical~~therapy ~~studies~~offers ~~have~~a ~~found~~promising ~~that~~new ~~T-cells~~approach ~~that~~to ~~are~~treating ~~more~~autoimmune ~~naive,~~diseases. ~~less~~In ~~differentiated,~~recent ~~and~~clinical ~~less~~studies, ~~exhausted~~CD19-redirected ~~correlate~~CAR T-cell ~~with~~therapy ~~improved~~has ~~efficacy.~~demonstrated ~~After~~the ~~T-cell~~potential ~~“expansion”,~~to ~~where~~go ~~T-cells~~beyond ~~proliferate~~symptom ~~multiple~~management ~~times~~by ~~during~~depleting anthe ~~immune~~entire ~~reaction~~population toof ~~fight disease~~autoreactive B cells, ~~but~~leading to ~~before~~rapid ~~antigen~~and ~~engagement,~~durable ~~AbTCR-T~~disease ~~cells~~remission. inA ~~the~~notable study ~~displayed~~in alupus ~~more~~patients ~~naive~~demonstrated ~~and~~that ~~stem~~a ~~cell~~single ~~memory~~dose Tof CD19-~~cell~~targeting ~~phenotype~~CAR ~~compared~~T-cells toresulted ~~the~~in ~~CAR~~significant Timprovements, with most patients entering remission and experiencing long-~~cells~~lasting benefits.

~~(c)~~We ~~Frequency~~plan to expand our clinical investigation of ~~naïve~~our ~~(CCR7+~~CD19-redirected ~~CD45RA+),~~ARTEMIS ~~central~~T-cell ~~memory~~therapy ~~(CM;~~into ~~CCR7+~~autoimmune ~~CD45RA−),~~diseases. ~~effector~~Our ~~memory~~EB201 ~~(EM;~~program, ~~CCR7-~~in ~~CD45RA-)~~preclinical ~~and~~development, ~~effector~~is being ~~(E;~~explored ~~CCR7-~~as ~~CD45RA+)~~a Tpotential ~~cells~~therapeutic ~~within~~approach ~~CD8+~~targeting ~~receptor+~~Systemic ~~cells~~Lupus Erythematosus (SLE).

~~(d)~~Our ~~Frequency~~Technology ofPlatform: ~~stem~~The ~~cell~~ARTEMIS® ~~memory (SCM; CCR7+ CD45RO~~T-Cell ~~CD95+~~Receptor ~~CD122+) T cells within CD8+ receptor+ cells.~~System

~~Taken together~~We ~~with~~hold ~~the~~an ~~shifts~~exclusive inlicense ~~increased~~from ~~CD28,~~Eureka ~~which~~Therapeutics (“Eureka”) isto autilize ~~protein~~the ~~expressed~~proprietary onARTEMIS® ~~T-cells~~Cell ~~that~~Receptor ~~provides~~platform ~~co-stimulatory~~to ~~signals~~develop ~~required~~and ~~for~~ commercialize T-cell ~~activation,~~therapies targeting CD19 and ~~lower~~CD22 ~~granzyme~~for B,the ~~which~~treatment ~~is a biomarker~~ of ~~immune~~hematologic ~~cell~~malignancies. ~~activation,~~Under onour ~~CD8+~~License ~~AbTCR-T cells~~Agreement, ~~the~~we ~~increased~~hold ~~CCR7~~exclusive ~~(a biomarker~~rights ~~for~~to ~~naïve~~develop and ~~stem cell memory T~~commercialize ARTEMIS-~~cells)~~based ~~expression~~products ~~indicates~~targeting ~~that~~CD19 ~~T-cells~~and ~~engineered~~CD22 ~~with~~in ~~AbTCR~~all ~~are~~territories ~~less differentiated. Furthermore~~worldwide, ~~expression~~excluding ofGreater ~~programmed~~China ~~cell death-1 (“PD-1”)~~ and ~~T-cell~~Association ~~immunoglobulin~~of ~~mucin-3~~Southeast Asian Nations (~~“TIM-3”~~ASEAN) countries, which are ~~both~~retained ~~markers~~by ~~of T-cell exhaustion, and TIM-3 were lower on AbTCR-T cells than in CAR-T cells~~Eureka.

6The ARTEMIS platform utilizes an Antibody-T Cell Receptor (AbTCR) architecture designed to potentially overcome limitations associated with conventional chimeric antigen receptor (CAR) T-cell therapies, such as toxicity and exhaustion. Unlike conventional second-generation CAR-T therapies, which rely on synthetic fusion proteins that can drive chronic hyperactivation (tonic signaling) and premature T-cell exhaustion, the ARTEMIS AbTCR is designed to mimic the natural regulation of native T-cells by recruiting endogenous CD3 complex to initiate T-cell activation. A critical differentiating feature of our platform is that the co-stimulatory molecule is provided as a separate protein rather than being covalently linked to the activation domain. By separating these signals, the ARTEMIS platform is designed to mimic the body’s natural immune regulation, potentially limiting T-cell hyperactivation.

Based on Eureka’s internal and published studies in Cell Discovery1 (ewith CHOP/UPenn) ~~Expression~~and ofCell TReports ~~cell~~Medicine2 ~~differentiation~~(with ~~markers CD28~~NCI), we ~~CCR7,~~believe ~~and~~the ~~granzyme~~ARTEMIS B.platform offers distinct advantages over conventional CAR-T constructs:

~~(f)~~● ~~Expression~~Improved ofSafety TProfile ~~cell~~and ~~exhaustion~~Economic ~~markers~~Potential: PDIn head-1to-head comparisons with market-standard CAR-T constructs, ~~LAG~~ARTEMIS T-3cells demonstrated comparable or superior antitumor potency with significantly reduced release of inflammatory cytokines, ~~and~~such ~~TIM~~as IL-36, which are drivers of cytokine release syndrome (CRS) and neurotoxicity. We believe this improved safety profile has the potential to allow for the administration of our therapies in outpatient settings rather than dedicated cancer centers, thereby decreasing the costs associated with patient monitoring and hospital stays.

~~Eureka next~~1 ~~characterized~~Cell ~~the~~Discovery ~~T-cell phenotypes resulting from activation through the AbTCR. Eureka co-incubated the CAR T-cells with Raji cells~~4, ~~which~~ ~~are~~62 ~~from a human B lymphoblastoid cell line originally derived from a patient with Burkitt Lymphoma. The Raji cells were either CD19-positive~~ (~~“CD19+”~~2018): ~~cells or cells in which CD19 was not present, or “knocked out” (“CD19ko”) using CRISPR technology, which allows for genetic material to be added, removed, or altered~~doi:10. ~~Upon engagement with CD19+ cells, the AbTCR T~~1038/s41421-~~cells expressed activation markers CD69 and CD25, demonstrating the ability of the ET190L1~~018-~~AbTCR to trigger T~~0066-~~cell activation in an antigen-dependent manner.~~6

72 Cell Reports Medicine 6, 102378 (2025) doi: 10.1016/j.xcrm.2025.102378.

The accumulation of CD107a, a marker for T-cell degranulation following stimulation, was determined as a measure of cellular degranulation, a prerequisite for T-cell-mediated bursting of tumor cells, or cytolysis. T-cells degranulated when the AbTCR was stimulated with CD19+ cells.5

8● Efficacy in Low-Antigen Density Tumors: Conventional CAR-T therapies often fail when tumor cells express low levels of target antigen, leading to tumor escape. The NCI studies from 2025 (conducted with the ARTEMIS platform targeting GPC2 in solid tumors) demonstrated that ARTEMIS T-cells maintain cytotoxic function at antigen densities below the threshold required to activate conventional CAR-T cells. The ability for ARTEMIS T-cells to function at a lower antigen level can potentially expand the addressable patient population and reduce the risk of relapse.

~~In addition,~~● ~~when~~Superior ~~AbTCR-~~T ~~cells~~cell ~~were~~Phenotype: ~~co-incubated~~Preclinical ~~with~~data ~~CD19+~~indicates ~~cells,~~that the ~~analysis~~ARTEMIS ~~with~~architecture ~~intracellular~~promotes ~~flow~~the ~~cytometry~~expansion ~~showed~~of ~~that~~stem-like ~~cytokines, such~~memory ~~as TNFα, IL~~T-2,cells (TSCM) and ~~IFNγ,~~reduces ~~are~~exhaustion ~~induced~~markers incompared ~~response~~ to ~~CD19~~standard ~~antigen~~CAR-T constructs. ~~Importantly,~~The noTSCM ~~cytokines~~subset ~~were~~of ~~produced when the AbTCR-~~T ~~cells~~ ~~were co-cultured with CD19ko~~ cells. ~~These~~have ~~data~~been ~~demonstrate~~reported ~~the~~to ~~ability~~be ofassociated ~~the~~with ~~AbTCR~~long-term topersistence ~~trigger~~and ~~T-cell~~durability ~~activation~~of inclinical ~~an antigen-dependent manner~~response.

~~To better characterize the activities of AbTCR~~STARLIGHT-~~T cells, Eureka set up experiments to directly compare phenotypes of the AbTCR-T cells with~~1: ~~the~~US ~~CAR-T~~Phase ~~cells.~~I/II ~~The~~Clinical ~~percentage~~Trial of ~~AbTCR-positive and CAR-positive T cells were matched by dilutions with un-transduced mock T-cells and co-cultured with multiple tumor cell lines.~~EB103

9EB103 is our lead CD19-targeted ARTEMIS® T-cell therapy product candidate designed to address high unmet medical needs in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (r/r B-NHL). We are currently evaluating EB103 in an open-label, dose escalation, multi-center, Phase I/II clinical trial in the U.S. (STARLIGHT-1, NCT06343311) in adult subjects (≥ 18 years of age) with relapsed/refractory (R/R) B-cell NHL. The study includes a dose escalation phase followed by an expansion phase. A traditional dose escalation model was used to determine the RP2D. The trial began enrolling patients in 2024, with UC Davis Comprehensive Cancer Center as the first clinical site. A second site (Baylor Scott and White Research Institute in Texas) was activated in April 2025.

*As ~~T-cells~~of December 2025, the Phase I dose escalation phase has been completed. The enrolled patient population (n=9) was heavily pretreated, with a median of three prior lines of therapy. Approximately 80% of the enrolled patients were ~~incubated~~considered high-risk, including patients with ~~target~~primary ~~cells~~refractory disease, ~~for~~high-grade 16B-cell ~~hours~~lymphoma, atand anprimary ~~effector~~CNS tolymphoma. ~~target~~Notably, ~~ratio~~33% of ~~2:1~~patients had undergone prior autologous stem cell transplantation, and 89% had received two or more prior regimens. ~~Cytotoxicity~~Two ~~was~~dose ~~measured~~levels bywere ~~lactate~~evaluated ~~dehydrogenase~~in ~~release~~Phase ~~assay~~I: Dose Level 1 (nDL1, n= 3) ~~technical~~at ~~replicates~~2.5 million receptor-positive T cells/kg, and Dose Level 2 (DL2, n=6) at 5 million receptor-positive T-cells/kg. Among the 9 patients in Phase I, no treatment-related serious adverse events were reported, and the high-dose cohort achieved a 100% complete response rate at Month 1 in all 5 evaluable patients.

~~Specific lysis,~~Safety ~~or disintegration, of only CD19+ tumor lines confirmed the antigen specificity of both the AbTCR-T cells~~ and CAR-T cells while demonstrating comparable cellular cytotoxicity and degranulation. In addition, specific lysis across a range of effector to target (“E:T”) ratios, or ratios of AbTCR T-cells versus tumor cells, also showed comparable T-cell killing at low E:T ratios, further demonstrating the cytotoxic potential of using the AbTCR.tolerability

10EB103 has a favorable and manageable safety profile in the nine patients treated in Phase I. While Cytokine Release Syndrome (CRS) was observed in all treated patients, all CRS events were low grade (Grade 1 or 2) and managed with standard of care. There were no instances of Grade 3 or higher CRS observed at either dose level. A majority of patients also experienced transient low grade ICANS, though the clinical symptoms were easily managed and the median duration of the events was only two days

Replicative capacity of therapeutic T-cell in leukemia patients has been reported to be a key predictive biomarker for clinical efficacy. Eureka used a fluorescent dye-based (or CFSE-based) assay to assess in vitro T-cell proliferation upon antigen stimulation. As shown in the graphic below, AbTCR-T cells divided in response to antigen with kinetics comparable to that observed with CAR-T cells.6

11Clinical Efficacy

~~Despite a~~In ~~slight~~the ~~increase~~Phase inI study the high-dose ~~expression~~cohort of(DL2) ~~CD69~~achieved ~~and~~a ~~CD25~~100% ~~activation~~(n=5/5) ~~markers,~~complete ~~which~~response ~~show~~rate ~~T-cell~~at ~~activation~~Month ~~levels,~~1 onin ~~tumor~~all ~~stimulated~~evaluable ~~AbTCR-T cells~~patients. ~~compared~~One topatient ~~CAR-T~~in ~~cells,~~the ~~AbTCR~~DL2 ~~CD4+~~cohort experienced ~~T-cells~~Grade ~~expressed~~5 ~~lower~~sepsis ~~levels~~on ofDay ~~the~~18; ~~PD-1~~this ~~exhaustion~~event ~~marker,~~was ~~than~~determined ~~CAR-T~~by ~~CD4+~~the ~~cells,~~investigator ~~and,~~to ~~in both~~be ~~CD4+~~unrelated ~~and~~to ~~CD8+~~the ~~AbTCR-T~~EB103 ~~cells~~therapy. Consequently, this ~~lymphocyte-activation~~patient ~~gene~~was 3,not orevaluable ~~LAG-3,~~for ~~which~~efficacy isresponse. anResponses ~~immune~~for ~~checkpoint~~all ~~receptor~~evaluable ~~protein~~patients ~~found~~have onbeen ~~the cell~~durable ~~surface~~to ofdate, ~~T-cells~~with ~~that~~all ~~has~~patients remaining ~~been~~in ~~found~~remission toas ~~inhibit~~of the ~~activation~~data ofcutoff ~~T-cells~~date ~~and~~on ~~suppress~~January ~~immune response~~28, ~~was lower~~2026.

12Pharmacokinetics

~~Furthermore, while~~Analysis ~~AbTCR-T~~of ~~cells~~peripheral ~~have~~blood samples ~~comparable~~confirmed ~~cytotoxicity~~robust ~~and~~cellular ~~proliferative~~expansion ~~potential~~of ~~compared~~EB103. toPharmacokinetic ~~existing~~data ~~CAR-T~~determined ~~cells,~~by quantification of the ~~AbTCR-T~~EB103 ~~cells~~transgene ~~released~~vector ~~lower~~copy ~~levels~~number ofshowed ~~inflammatory~~a ~~cytokines,~~median ~~including~~Cmax ~~TNF-α,~~of ~~IL-2~~77,693 ~~IFN-γ,~~copies/ug ~~and~~gDNA ~~GM-CSF,~~with ~~after~~ a 16median ~~hour~~Tmax inof ~~vitro~~8 ~~killing test~~days.

~~Comparisons between~~Development ~~TCR-T~~Plan and CAR-T cells have previously shown that activation through the TCR can comparatively reduce cytokine release while simultaneously increasing antigen sensitivity. Although the CAR construct incorporates a covalently-linked CD28 costimulatory domain, Raji cells express CD80 and CD86 and thus provide CD28 costimulation to both CAR-T cells and AbTCR-T cells. The study suggests that the cytokine secretion and exhaustion differences between AbTCR and CAR-T cells stem from the utilization of endogenous signaling pathways by the γδTCR effector domain of the AbTCR receptor.

~~While the~~In ~~potential~~December ~~of AbTCR-T cells to reduce the secretion of several inflammatory cytokines has exciting clinical possibilities~~2025, ~~the~~an ~~discovery~~independent ~~that~~Data ~~tocilizumab,~~Safety anMonitoring ~~anti-IL6R~~Board ~~antibody, alleviates CRS pathology, singles out interleukin 6 receptors~~ (~~IL6R~~DSMB) ~~with~~completed ~~particular~~its ~~clinical significance.~~review ~~Because the majority~~ of ~~IL-6~~safety isdata ~~produced~~from bythe ~~antigen-presenting~~Phase ~~cells,~~I ~~including monocytes, macrophages, and dendritic cells, Eureka performed a co~~dose-~~culture~~escalation ~~assay~~phase to(n=9) ~~measure IL-6 concentrations. The experiment separated T-cells~~ and ~~tumor~~recommended ~~cells from monocyte-lineage~~advancing ~~cells. Next,~~ the ~~AbTCR-T~~trial ~~cells~~into ~~were compared to one of~~ the ~~anti-CD19~~Phase ~~CAR-T~~II ~~cells~~expansion ~~that~~phase ~~had~~at ~~been~~the ~~extensively~~recommended ~~studied~~Phase ~~and~~II ~~FDA-approved~~dose (~~CTL019, a~~RP2D). ~~research~~Patient ~~grade~~dosing ~~version~~for ofPhase ~~Kymriah™).~~II Inhas ~~addition,~~commenced ~~CTL019~~in ~~uses~~January 2026 ~~CD137~~to ~~(4-1BB),~~further aevaluate ~~costimulatory~~EB103 ~~receptor,~~at ~~for~~RP2D ~~costimulation,~~in ~~thus offering~~a anlarger ~~opportunity~~patient cohort to ~~compare~~confirm the ~~AbTCR~~Phase toI ~~a CD137-based CAR-T cell~~results.

137

Similar to the observed differences in cytokine release between the AbTCR-T cells and CAR-T cells, the AbTCR-T cells released lower levels of TNF-α, IL-2, IFN-γ, GM-CSF compared to CTL019-T cells. In the figure below, the purple bar indicates CTL019 targeting NALM-6 (B cell precursor leukemia) plus APCs (monocyte-lineage cells). The green bar indicates AbTCR T cells targeting NALM-6 plus APCs. The blue bar indicates plain T cells (without engineering) targeting NALM-6 plus APCs.Manufacturing

~~The study~~Pursuant ~~found~~to ~~that~~the Services ~~AbTCR-T~~Agreement ~~cells~~and ~~induced~~Statement ~~monocyte-lineage~~of ~~cells~~Work to#001, ~~release~~among ~~substantially~~other ~~less~~services, ~~IL-6~~Eureka ~~than~~agreed ~~CTL019-T~~to ~~cells.~~provide ToEstrella ~~test~~with ifaccess ~~the~~to Eureka’s ~~reduced~~T-cell ~~cytokine~~manufacturing ~~release~~and ~~had~~lentiviral anvector ~~effect~~(LVV) onprocesses in ~~vivo~~connection ~~anti-tumor~~with ~~activity,~~the ~~Eureka~~IND ~~used~~application ~~AbTCR-T~~and ~~cells~~clinical totrials ~~treat~~for aEB103. ~~patient-derived xenograft~~See ~~(PDX)~~“Material ~~mouse~~Agreements ~~model of primary B~~-~~ALL~~ ~~(CHP105R1,~~Services ~~which~~Agreement ~~has~~and ~~fewer~~Statement ~~cytokines due to lack~~ of ~~CD28~~Work ~~ligand~~#001” below for ~~co-stimulation)~~additional ~~and~~information ~~observed similar~~regarding ~~tumor~~the ~~inhibition~~terms ~~between~~of ~~mice treated with~~ the ~~AbTCR and CTL019-T cells~~agreements.

14EB104 T-cells

~~Thus,~~EB104 T-cells are engineered ~~consistent~~to ~~with~~express ARTEMIS® cell receptors (i.e., the AbTCR and co-stimulatory molecule) on their cell surfaces in ~~vitro~~a ~~studies~~manner ~~described~~similar to ~~above~~EB103. Like EB103, both the ~~study~~AbTCR ~~concluded~~and ~~that~~co-stimulatory molecule of EB104 are designed to recognize and bind the CD19 antigen. In addition, the AbTCR in EB104 T-cells ~~engineered~~recognizes and binds the CD22 antigen as well. Once infused, EB104 T-cells are able to engage CD19- and CD22-positive cancer cells. The AbTCR expressed on the EB104 T-cell by its nature associates, via its effector domain (γδ TCR chains), with the endogenous CD3 complex. When the AbTCR ~~reduced~~binds ~~cytokine~~to ~~release~~its target, CD19 or CD22, expressed on the cancer cell, AbTCR/CD3 complex-mediated ~~without~~signal atransduction ~~loss~~within the EB104 T-cell is initiated. This signal transduction process ultimately leads to the activation of ~~anti~~the EB104 T-~~tumor~~cell. ~~activity~~A second “enhancement” signal is generated when the co-stimulatory molecule expressed on the EB104 T-cells binds to its target, CD19, expressed on the cancer cell. Although the co-stimulatory molecule expressed on EB104 T-cells cannot bind to CD22, EB104 T-cells are able to engage CD19 or CD22 (with the AbTCR) while the co-stimulatory molecule binds to CD19. Like EB103, the main function of the co-stimulatory molecule is to “boost” AbTCR signaling, resulting in aincreased ~~PDX~~expansion ~~tumor~~and ~~model~~survival ~~that~~of ~~lacked~~EB104 ~~CD80~~T-cells inside the body, and ~~CD86~~the ~~costimulation~~co-stimulatory molecule has also been optimized to provide EB104 T-cells with enhanced T-cell activation. In summary, EB104 T-cells seek out CD19 and CD22-positive cancer cells, bind to these cells, and destroy them.

~~The study~~Despite ~~next~~impressive ~~tested the in vivo anti-tumor activity~~ outcomes of ~~the AbTCR~~CAR-T ~~cells in an established human CD19+ Raji B-~~cell ~~lymphoma~~treatments ~~xenograft~~over ~~model. As shown in~~ the ~~figures~~past ~~below~~five years, ~~the~~more ~~study~~than ~~found~~50% ~~that~~of ~~both~~patients ~~the~~treated ~~AbTCR~~with ~~and~~CD19-targeted ~~ET190L1 T~~CAR-T cell ~~treatments~~therapy ~~resulted in tumor regression and long-lasting~~experience ~~tumor~~progressive ~~rejection~~disease. AtIn ~~the~~addition, ~~time~~many ~~when~~patients ~~mice~~ treated with ~~mock~~CD19-target TCAR-~~cells~~T ~~had~~cell totherapies besubsequently ~~euthanized,~~show ~~tumor~~absent ~~burden~~or ~~was~~low onCD19. ~~average approximately 1000-fold~~Further, ~~less~~disease inprogression ~~mice~~associated ~~treated~~ with ~~ET190L1~~loss ~~T-cells~~of ~~than~~cell insurface ~~the~~CD19 ~~mock-treated~~has ~~mice~~been ~~and~~reported onin ~~average~~30 ~~approximately~~– ~~5300-fold~~95% ~~less~~of inrelapses ~~mice~~after ~~treated~~CD19-targeted ~~with AbTCR~~CAR-T therapy ~~cells than~~ in ~~the~~B-cell ~~mock~~acute ~~arm~~lymphoblastic ~~in the experiment~~leukemia. ~~The~~We ~~figure~~believe ~~below~~that ~~shows~~this ~~bioluminescent~~obstacle ~~images~~can ~~(left)~~be ~~and~~addressed ~~total~~by ~~flux~~dual-targeting ~~(right)~~both ~~over time~~CD19 ofand ~~three~~CD22 ~~groups~~with EB104. ofFor ~~six~~patients tothat ~~eight~~may ~~Raji-implanted~~exhibit ~~mice~~lower ~~intravenously~~CD19 ~~administered~~surface ~~with~~density, 5EB104 ×has ~~106~~the ~~(1)~~potential ~~un-transduced~~to ~~donor-matched T-cells~~bind ~~(“Mock”),~~to ~~(2)~~both ~~ET190L1-CAR-T~~CD19 ~~cells~~and ~~(“CAR”),~~CD22 orto ~~(3)~~increase ~~AbTCR-T cells (“AbTCR”). Doses were based~~the onodds ~~number~~ of ~~receptor~~effective T-~~positive~~cell ~~cells~~therapy.

15EB104 Preclinical Data

~~The~~To test the anti-tumor ~~ability~~activity of ~~persisting~~EB104 ~~AbTCR-T~~towards ~~cells~~low toor ~~prevent~~no ~~growth~~CD19 ofsurface ~~“newly-introduced”~~expression ~~tumor~~cancer cells, ~~was~~in ~~tested~~2019, byEureka reconstructed a Nalm-~~injecting~~6-CD19ko ~~mice~~cell line, which is a B-cell precursor leukemia cell line, with the “knockout” of CD19 gene expression. This cell line mimics ~~tumor~~patients’ ~~cells~~diminished ~~weeks~~CD19 surface expression after ~~the~~CD19-directed immunotherapies. To confirm if EB104 T-cells ~~had~~have ~~cleared~~ the potential ~~initial~~to ~~tumor~~overcome ~~burden.~~CD19 ~~While~~antigen ~~tumors~~loss ~~grew rapidly~~ in ~~control~~cancer ~~mice~~cells, ~~two~~Eureka totested ~~three~~the activity of EB104 as well as EB103 cells in mice using inNSG™ ~~each~~xenograft ofmodels ~~the~~(which ~~six~~are ~~groups~~highly ~~treated~~immunodeficient ~~previously~~mice) of leukemia with ~~either~~Nalm-6 ~~AbTCR~~and Nalm-T6-CD19ko cells orwith ~~CAR-T~~a bioluminescence ~~cells~~reporter. ~~were~~The ~~resistant~~total toflux ~~Raji~~from ~~lymphoma~~the ~~re-challenge~~bioluminescence ~~(left)~~reporter measured the tumor growth. In the experiments shown ~~Furthermore~~below, aEureka ~~set~~tested ofEB104, ~~two~~EB103, and mock T-cells head-to-head, ~~three~~against the NSG™ xenograft model, with six mice infor each treatment ofgroup, ~~the~~respectively. ~~six~~Four ~~groups~~days ~~were~~before rethe T-~~challenged~~cells ~~with~~were ~~NALM-6~~infused, ~~cancer~~0.5x106 leukemia cells Nalm-6 (~~right),~~expressing ~~which~~both isCD19 ~~CD80~~ and CD22) ~~CD86~~with ~~negative~~bioluminescence reporter were injected into mice. ~~The~~Four ~~resistance~~days later, the mice were infused with a total of ~~tumor~~T-cells containing ~~growth~~EB103 ~~showed~~or ~~that~~EB104, ~~AbTCR~~or mock T cells, using the mock T-cells ~~can~~as bethe ~~used~~control ~~for~~group. The infusion of EB103 and EB104 showed tumor ~~types~~control ~~which~~until doday ~~not~~21, ~~express~~while ~~CD28~~the ~~relevant ligands~~control group showed rapid tumor growth.

The study found that in vivo cytokine release and exhaustion markers on T-cells recapitulated in vitro findings. Whereas ET190L1 T-cell treatment caused marked elevation of inflammatory cytokines, including IL-2, IL-10, IFN-γ, and TNF-α, lower levels of these cytokines were released following AbTCR treatment. Serum cytokine levels were collected and measured from six to eight Raji-bearing mice 24 hours after T-cell dosing.8

16Furthermore, EB104 showed potentially better tumor control compared to EB103. At day 21, Nalm-6 cells with 1% Nalm-6-CD19ko (expressing CD22, but not CD19) cells were injected into mice that were previously treated by EB103 or EB104 as re-challenge. This re-challenge experiment mimicked the tumor relapse in patients due to CD19 antigen escape. Mice treated with EB104 showed “durable” tumor control, meaning that the tumor continued to respond to treatment without the cancer growing or spreading, and “clearance” of tumors, which refers to the complete killing of tumor cells, for a total of more than 60 days, or 40 days after the re-challenge. However, mice treated with EB103 showed rapid tumor growth after the re-challenge.

TThese pre-~~cell~~clinical results ~~collected~~showed ~~from~~that ~~peripheral~~EB104 ~~blood nine days and 15 days post-~~T-~~cell~~cells ~~dosing~~have ~~also~~the ~~revealed~~potential ~~that~~to ~~AbTCR~~eradicate Nalm-T6 ~~cells~~Primary ~~expressed~~Tumors ~~lower~~and ~~levels of PD~~Nalm-~~1 than CAR~~6-TCD19ko ~~cells. PD~~re-1challenge ~~expression~~tumors ~~levels~~in ~~(measured~~the byxenograft model, ~~mean~~suggesting ~~fluorescent~~that ~~intensity)~~EB104 ~~are shown below on the CAR-~~T -cells ~~and~~have ~~AbTCR~~the ~~T-cells at~~potential ~~select~~to ~~times~~control ~~from~~the ~~six~~growth toof ~~eight~~tumor ~~Raji-bearing~~cells ~~mice~~that ~~after~~do ~~T-cell~~not ~~infusion~~express CD19.

~~Collectively, the~~Our ~~data~~Collaboration ~~from~~with ~~the~~Imugene ~~study suggested that AbTCR T-cells exhibited potent in vitro~~ and ~~in vivo anti~~CF33-~~tumor activity, yet released lower levels of inflammatory cytokines and expressed lower levels of exhaustion markers than CAR-T cells.~~CD19t

17CF33-CD19t and EB103

~~Following~~A major challenge for current T-cell therapies is the ~~study,~~identification toof ~~further~~antigens ~~augment~~that ~~AbTCR~~are ~~signaling,~~expressed ~~Eureka~~only ~~subsequently~~on ~~optimized~~tumors ~~the~~and ~~ARTEMIS®~~not ~~cell~~in ~~receptor~~healthy ~~platform~~tissue. toIn ~~include~~ the ~~co-stimulatory~~absence ~~molecule.~~of ~~Importantly~~such restricted expression, ~~the co~~CAR-~~stimulatory~~T ~~molecule~~cell istherapy ~~provided~~poses asconsiderable asafety ~~separate~~concerns ~~molecule~~ and ~~not~~potentially ~~directly~~narrows ~~fused~~therapeutic towindow ~~the~~for their application ~~AbTCR~~against solid tumors. ~~This~~CD19 ishas inbeen ~~contrast~~an toideal ~~conventional~~target ~~CARs~~for CAR-T cells against hematological malignancies for several reasons, ~~which~~including its ~~include~~highly ~~the~~restricted ~~direct~~expression ~~fusion~~on ofB ~~the~~cells ~~target~~and acceptable off-~~binding~~tumor ~~domain~~and on-target properties. In addition to the ~~co-stimulatory~~shared ~~and~~expression of ~~CD3ζ~~solid ~~domains~~tumor antigens on normal tissue, ~~which~~most ~~drives~~of ~~sustained~~these ~~T-cell~~antigens ~~activation~~also have heterogeneous and, ~~often~~nonuniform expression patterns in tumors, ~~subsequent~~limiting the ~~release~~potential offor ~~large~~effective ~~amounts~~and ofdurable ~~inflammatory~~antitumor ~~cytokines~~responses. ~~Thus~~ Many solid tumors, ~~unlike~~including ~~the~~triple-negative ~~linear~~breast ~~CAR~~cancers ~~design~~and ofliver ~~traditional~~cancers, lack amenable tumor antigens for CAR-T cell ~~platforms,~~development. To potentially address the ~~configuration~~issue of the ~~ARTEMIS®~~lack ~~cell~~of ~~receptor~~solid tumor-specific targets, ~~platform~~we ~~resembles~~are ~~the~~collaborating ~~endogenous~~with ~~TCR/co-stimulatory~~Imugene ~~receptor~~and ~~architecture~~its inproduct ~~which~~candidate, coCF33-~~stimulation~~CD19t, isto ~~provided~~research ~~through~~the ~~separate~~use ~~receptors and~~of ~~acts~~EB103 asin aconjunction ~~potent~~with ~~synergistic~~CF33-CD19t ~~signal~~to treat ~~that~~solid istumors ~~naturally~~using ~~regulated~~a by“mark ~~the~~and ~~body~~kill” strategy.

~~EB103~~This “mark and kill” strategy entails first using CF33-CD19t to infect solid tumor cells which induces them to express the CD19 protein on the cell surface, thereby labeling the tumor cell as a target for EB103 T-Cells. The EB103 T-cells are then infused into the patient where they would target and kill the now CD19-positive solid tumor cells.

~~During the~~Collaboration manufacturing process, our EB103 T-cells are engineered to express ARTEMIS® cell receptors (i.e., the AbTCR and co-stimulatory molecule) on their cell surfaces. Both the AbTCR and co-stimulatory molecule of EB103 are designed to recognize and bind the CD19 antigen. The resulting EB103 T-cells are expanded and then cryopreserved for delivery into the patient. Once infused, EB103 T-cells engage CD19-positive cancer cells. The AbTCR expressed on the EB103 T-cell by its nature associates, via its effector domain (γδ TCR chains), with the endogenous CD3 complex. When the AbTCR binds to its target, CD19, expressed on the cancer cell, AbTCR/CD3 complex-mediated signal transduction within the EB103 T-cell is initiated. This signal transduction process ultimately leads to the activation of the EB103 T-cell. A second “enhancement” signal is generated when the co-stimulatory molecule expressed on the EB103 T-cells binds to its target, CD19, expressed on the cancer cell. The main function of the co-stimulatory molecule is to “boost” AbTCR signaling, resulting in increased expansion and survival of EB103 T-cells inside the body. The co-stimulatory molecule has also been optimized to provide EB103 T-cells with enhanced T-cell activation. In summary, EB103 T-cells seek out CD19-positive cancer cells, bind to these cells, and destroy them.Agreement

~~EB103~~On October 29, 2021, Eureka ~~Clinical~~entered ~~Studies~~into a collaboration agreement (the “Collaboration Agreement”) with Imugene, a clinical stage immuno-oncology company, to evaluate the use of CF33-CD19t in conjunction with Eureka’s CD19 ARTEMIS T-cell therapy for the treatment of solid tumors.

~~First Affiliated Investigator-Initiated Study~~9

18On July 28, 2022, as part of the Separation, Eureka contributed and assigned the Collaboration Agreement to Estrella. Pursuant to the Collaboration Agreement, Estrella and Imugene have each granted to the other a royalty free, non-exclusive, worldwide license, with the right to grant and authorize sublicenses, to their respective technologies to conduct the research activities each is responsible for performing under the research plan set forth in the Collaboration Agreement. The research plan under the Collaboration Agreement was completed as of August 30, 2023.

~~From November~~Potential ~~2018~~Uses to April 2021, the First Affiliated Hospital of Xi’an Jiaotong University (“First Affiliated”) conducted an exploratory, single-arm, open-label, non-randomized early investigator-initiated study (“IIS”) to assess the safety and ~~feasibility~~ ~~of administering EB103 T-cells to patients with CD19-positive relapsed~~Expansion/refractory(r/r) B-cell lymphoma. Unlike studies conducted by pharmaceutical companies, IISs are clinical studies initiated and managed by nonpharmaceutical company researchers who could be an individual investigator, an institution, or a group of institutions, a collaborative study group, or a cooperative group. Often, as in this case, IIS studies are exploratory in nature. Generally, IISs are reviewed and approved by review boards or ethics committees at hospitals. First Affiliated sponsored the IIS study in collaboration with Eureka and conducted the study at First Affiliated. Eureka provided EB103-related information to support the IIS study application and gave comments to the investigator on the IIS study design and clinical protocol. The Ethics Committee of First Affiliated reviewed preclinical data and approved the clinical protocol. The study was registered at www.clinicaltrials.gov as #NCT03642496.All participants in the study provided written informed consent. The study results were published in 2022 in the Journal of Cancer Research and Clinical Oncology.Market

~~Patients were~~Solid ~~eligible~~tumors ~~for~~represent ~~the study if they had histologically confirmed CD19-positive r/r B-cell lymphoma. Previous therapy must have included~~approximately ~~at least one cycle of R-CHOP (rituximab~~1, ~~cyclophosphamide~~600,000 ~~doxorubicin,~~new ~~vincristine~~cancer cases, ~~and prednisone)~~ or a90% ~~similar~~of ~~R-CHOP,~~total ~~like~~cancer ~~chemotherapy. Eligibility~~diagnoses ~~also~~in ~~required~~the ~~measurable~~United ~~disease~~States, aseach ~~defined~~year. byAt atthis ~~least~~time, ~~one~~there ~~measurable~~are ~~node~~no ~~of which the longest diameter (LDi) is greater~~FDA-approved ~~than~~CAR ~~1.5 cm~~ or atTCR-T ~~least~~cell ~~one~~therapies ~~measurable~~approved ~~extra~~for ~~nodal~~the ~~lesion~~treatment of ~~which~~solid ~~the LDi is greater than 1~~tumors.0 ~~cm. In addition~~Accordingly, anit ~~Eastern Cooperative Oncology Group (ECOG) performance status, which~~ is ~~used~~currently bydifficult ~~doctors and researchers~~ to ~~assess~~estimate ~~how~~specific ~~a patient’s disease is progressing,~~market ~~how~~projections ~~the~~and ~~disease affects~~ the ~~daily~~potential ~~living~~for ~~abilities~~our of“mark ~~the patient,~~ and ~~determine~~kill” ~~appropriate treatment and prognosis, of less than or equal to two was required~~strategy.

~~The primary~~Our ~~endpoints~~Team ~~included the tolerability of EB103 T-cell therapy~~ and the cellular kinetics (i.e., expansion and persistence, which refers to the number of T-cells and continuous presence of T-cells in vivo after infusion) of EB103 T-cells after infusion. Secondary endpoints and other terms used in the study are explained below:Investors

●Pursuant ~~Complete~~to ~~Response~~the Services ~~(CR):The~~Agreement ~~disappearance~~entered into on June 28, 2022 and Statement of ~~all~~Work ~~signs~~entered into on March 4, 2024, we are supported by Eureka’s scientific team, which is comprised of ~~cancer~~leaders in ~~response~~the biopharmaceutical, oncology, and T-cell cancer immunotherapy areas. We have leveraged their expertise to ~~treatment~~analyze preclinical data and design and implement our clinical trials. ItOur isCEO ~~also~~and President, ~~called~~Dr. ~~complete~~Cheng ~~remission~~Liu, and members of our scientific advisory board are pioneers in their respective fields, each having spent their careers advancing next-generation technologies and providing treatments in these areas. ~~For~~Our ~~tumor~~Chief ~~assessments~~Financial ~~after~~Officer, ~~EB103~~Peter ~~treatment~~Xu, brings ayears CRof ~~indicated~~executive experience and investment management abilities. In August 2024 we welcomed Ms. Hong Zhang as our Chairperson of the ~~disappearance~~Board. Ms. Zhang is a highly accomplished executive with over 25 years of ~~measurable~~experience ~~disease~~in ~~via~~financial ~~computerized~~and ~~tomography~~corporate strategy. ~~(CT)~~We ~~scan~~believe orthe ~~residual~~addition ~~masses~~of ~~that~~Ms. ~~are~~Zhang ~~positron~~to ~~emission~~our ~~tomography~~Board ~~(PET)-negative~~will bring new opportunities to the company’s fundraising efforts.

●Our ~~Partial~~Board ~~Response~~includes ~~(PR):A~~experienced industry ~~decrease~~leaders inand ~~the~~investors ~~size~~who ofhave abeen ~~tumor,~~involved orwith inmany ~~the~~early-stage ~~extent~~companies. ~~of cancer in the body~~Furthermore, inwe ~~response~~are tosupported ~~treatment.~~by Itinvestors iswho share ~~also~~our ~~called~~belief ~~partial~~that ~~remission.~~the ~~For~~world ~~tumor~~needs ~~assessments~~smarter ~~after~~medical ~~EB103~~treatments ~~treatment,~~and aour PRlong-term ~~indicates~~vision atthat ~~least~~T-cell ~~50%~~therapies ~~decrease~~have inthe ~~tumor~~potential ~~burden~~to transform ~~with~~the ~~ongoing~~way ~~PET~~we ~~avidity~~fight cancer.

~~● Objective Response Rate (ORR):The proportion of patients with a complete response (CR) or partial response (PR) to treatment.~~Competition

●The ~~Duration~~biotechnology ofand ~~Response~~pharmaceutical industries ~~(DoR):the~~are ~~length~~characterized ofby ~~time~~rapid, ~~that~~unpredictable atechnological ~~tumor~~advancement ~~continues~~and tosignificant ~~respond~~competition. These industries dedicate significant resources to ~~treatment~~developing ~~without~~novel and proprietary therapies for the treatment of cancer, ~~growing~~which oroften ~~spreading~~incorporate innovative technologies and incorporate valuable intellectual property. ~~For~~We ~~tumor~~compete ~~assessment~~with ~~after~~companies ~~EB103~~in ~~treatment~~the cell therapy and immunotherapy space, ~~DoR~~as iswell as with companies developing other novel targeted therapies for cancer. If approved, our product candidates will compete with commercially available and development-stage innovative products in the ~~time~~fields ~~from~~of cell and immunotherapy, as well as against existing products generally accepted as the ~~first~~standard-of-care ~~documented~~for ~~disease~~indications ~~response~~in ~~(CR~~which orwe ~~PR)~~plan to ~~the~~seek ~~date~~marketing ofapproval. ~~first~~We ~~documented~~anticipate ~~progression~~that orwe ~~death~~will face intense and increasing competition from many different sources, including new and established biotechnology and pharmaceutical companies, academic research institutions, governmental agencies, and public and private research institutions.

●Our ~~Remission:~~product Acandidates ~~decrease~~cover inboth orhematological ~~disappearance~~malignancies ofand ~~signs~~solid tumors, and ~~symptoms~~we ofexpect ~~cancer.~~to Inface ~~partial~~direct ~~remission,~~competition ~~some,~~in ~~but~~both ~~not~~areas ~~all,~~from ~~signs~~companies ~~and~~focused ~~symptoms~~on ofCAR-T ~~cancer~~and ~~have~~other ~~disappeared~~cell-based therapies. InThere ~~complete~~are currently ~~remission,~~ten ~~all~~total ~~signs~~FDA-approved ~~and~~drugs ~~symptoms~~or oftherapies ~~cancer~~targeting ~~have disappeared~~CD19, ~~although~~five ~~cancer~~of ~~still~~which ~~may~~are beCD19-targeting inT-cell ~~the body.~~therapies:

● Stable Disease: Cancer that is neither decreasing nor increasing in extent or severity.

COMPANY	BRAND NAME	YEAR FIRST APPROVED	DISEASE(S)	LOCATIONS APPROVED
Novartis	Kymriah	2017	Pediatric/Young Adult B-ALL; R/R DLBCL; R/R Follicular Lymphoma	US, EU, UK
Kite Pharma (Gilead)	Yescarta	2017	R/R Large B-cell Lymphoma; R/R Follicular Lymphoma; R/R Primary CNS Lymphoma	US, EU, UK
Kite Pharma (Gilead)	Tecartus	2020	R/R Mantle Cell Lymphoma (MCL); Adult B-ALL	US, EU, UK
Juno (Bristol Myers Squibb)	Breyanzi	2021	R/R LBCL; CLL/SLL; Follicular Lymphoma; Mantle Cell Lymphoma; Marginal Zone Lymphoma	US, EU, UK
Autolus	Aucatzyl	2024	Adult Relapsed/Refractory B-cell precursor Acute Lymphoblastic Leukemia (ALL)	US, EU, UK

●Our ~~Progressive~~competitors ~~Disease:~~operating in ~~Cancer~~the ~~that~~T-cell istherapy ~~growing,~~space ~~spreading~~include, orbut ~~getting~~are ~~worse.~~not limited to:

~~Tumor assessments~~● ~~were~~Novartis conducted at one, two, three, six, nine, 12, 18, and 24 months after initial infusion and response to treatment was assessed by the principal investigator and radiologist according to the Lugano Classification 2014 (~~“Lugano~~Product: ~~Criteria”~~Kymriah), which is the most recent guideline to assess the presence of lymphoma, measure response to therapeutics intervention, and evaluate imaging and clinical data. By the Lugano Criteria, a CR indicates the disappearance of measurable disease via computerized tomography (CT) scan or residual masses that are positron emission tomography (PET)-negative. PR indicates at least a 50% decrease in tumor burden via PET scan.

19● Kite Pharma, Inc. (Products: Yescarta, Tecartus, KITE-753 and KITE-363)

Between November 2018, and April 2021, 16 patients were enrolled, and a total of 12 patients received EB103 T-cells. Four patients did not receive an infusion because of an inability to manufacture T-cells as a result of the patient’s poor T-cell activation (one patient), high tumor burden (one patient), or active infection (two patients). As of the data cutoff date in April 2021, the median duration of follow-up was 128 days (range: 34 to 728 days). Of the 12 patients treated, six patients (50%) achieved a CR, and four (33%) achieved a PR, with a best ORR of 83%. CRs were durable, including two patients with ongoing CRs for over 22 months.10

~~EB103 was~~● ~~well-tolerated~~Juno byTherapeutics ~~patients in the IIS study~~Inc. ~~No patients experienced severe~~ (~~grade~~Bristol >Myers ~~3, based on the standards set by the American Society for Transplantation and Cellular Therapy~~Squibb) ~~CRS,~~(Product: and only one patient experienced ICANS of any grade. In addition, heightened elevations of cytokine levels were not seen, even in patients with a marked expansion of EB103 T-cells. For the small patient population size, a P-value is not available.Breyanzi)

~~While additional~~● ~~studies~~JW ~~are~~Therapeutics ~~required~~(Product: ~~to confirm the results of this small, exploratory IIS study, the findings are consistent with the design of the ARTEMIS® platform as a potential alternative to other engineered T~~Carteyva/Relma-cell therapies, such as CAR T-cell therapies. The results from this early IIS study were disclosed to the FDA as supplementary supporting information for the IND application of EB103 in malignant B-cell lymphoma treatment.cel)

~~Clinical Responses~~● toAllogene ~~EB103~~Therapeutics (Product: Cema-cel)

~~(a)~~● ~~Treatment~~Mustang ~~response~~Bio ~~and duration of response after initial infusion of EB103 T-cells. Black arrows indicate ongoing remission and follow-up.~~ (b)Product: Best response for the 12 patients. Best response was defined as the best response (i.e., CR > PR > SD > PD) the patient achieved at any time after receiving EB103. CR — complete response, PR — partial response, SD — stable disease, PD — progressive disease. (c) Representative radiographic images of two responders (BH05MB-~~P10 and BH05-P19~~106) at baseline and the indicated time points after EB103. Red or yellow arrows mark the tumor lesions. Full body images are PET-CT scans. Cross-sectional images are PET scans (top rows) and CT scans (bottom rows). Scale bars: black, 20 cm; red, 6 cm.

20● Poseida Therapeutics (Product Candidates: P-MUC1C-ALLO1, and P-CD19CD20-ALLO1)

~~Levels of~~● ~~cytokines~~Autolus ~~and~~Therapeutics ~~serum~~PLC ~~inflammatory~~(Product ~~markers~~Candidates: ~~after EB103 T~~obe-~~cell~~cel ~~infusion~~and Auto1/22)

21Our competitors pursuing CD19 targeted drugs outside of the T-cell therapy space include, but are not limited to:

~~(a)~~● ~~Cytokine~~Amgen, ~~levels~~Inc. (~~b) Serum c-reactive protein (CRP) and ferritin levels in patients during the first month of EB103. Horizontal lines denote median values. Patients’ best responses are denoted by color of the symbols~~Product: CRBlincyto ~~(red), PR (blue), SD (green),~~ and ~~PD (black~~Uplizna).

~~Union Hospital~~● ~~Clinical~~MorphoSys ~~Study~~AG (Novartis) (Product: Monjuvi)

~~From July~~● ~~2019~~ADC toTherapeutics ~~August~~SA ~~2022, Union Hospital affiliated to Huazhong University of Science and Technology in Wuhan, China~~ (~~“Union~~Product: ~~Hospital”~~Zynlonta), in collaboration with Eureka, conducted the first-in-human, single-center investigator-initiated study designed to evaluate the safety and efficacy of EB103 T-cells in patients with CD19 malignancies. Eight patients with relapsed or refractory diffuse large B-cell lymphoma (RR DLBCL) were reported in the study. The Medical Ethics Committee of Union Hospital approved the study. The study was performed at Union Hospital in Wuhan, China. The study was registered at www.clinicaltrials.gov as #NCT04014894. The study results were published on January 21, 2023 in the Journal of Hematology & Oncology.

22Universities and research institutes have been a proven new technology source in the field as well. We also face competition from treatments in the field of immunotherapy which are being developed and/or commercialized by several biotechnology companies as well as by large pharmaceutical companies, whose immuno-oncology programs focus on the same indications or antigen targets as our current pipeline. Other known types of immunotherapy, including but not limited to checkpoint inhibition and cancer vaccines, are not currently direct competitors to T-cell-based therapeutics. However, we cannot predict whether these other types of immunotherapy may eventually show efficacy in the indications for which we may seek marketing approval, and it is possible that we may face direct and substantial competition from such sources in the future.

~~Eureka~~Many of our current or potential ~~collaborated~~competitors, ~~with~~either ~~Union~~alone ~~Hospital~~or towith ~~support~~a ~~the~~strategic ~~study.~~partner, ~~The~~have ~~fully~~significantly ~~human~~greater ~~anti-CD19~~financial, ~~antibody~~technical, ~~was~~and ~~selected~~human ~~from~~resources, ~~Eureka~~as ~~Therapeutics~~well ~~E-ALPHA®~~as ~~phage~~more ~~display~~expertise ~~library.~~in ~~Dr.~~research ~~Cheng~~and ~~Liu~~development, ~~Eureka’s~~manufacturing, ~~President~~preclinical testing, ~~CEO~~conducting clinical studies and ~~Chairman,~~trials and Qicommercializing and ~~Chang,~~marketing anapproved ~~employee~~products. ofCompetitors ~~Eureka,~~may ~~supervised EB103~~compete ~~production~~with us in hiring scientific and ~~conducted~~management ~~the~~personnel, ~~preclinical~~establishing ~~research.~~clinical study ~~Dr.~~sites, ~~Cheng~~registering ~~Liu~~patients for clinical studies and Qiacquiring ~~Chang~~technologies ~~are~~complementary ~~two~~to, ofor ~~the~~necessary ~~twenty-one~~for, ~~listed~~our ~~authors~~programs. ofMergers and acquisitions in the ~~report,~~ biotechnology and ~~each’s~~pharmaceutical ~~employment~~industries bymay ~~Eureka~~result ~~was~~in ~~disclosed~~even asmore resources being concentrated among a ~~competing~~smaller number ~~interest~~of competitors. NoSmaller ~~other~~or ~~competing~~early-stage ~~interests~~companies ~~were~~may ~~declared~~also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

~~Inclusion and~~Intellectual ~~Exclusion Criteria~~Property

The inclusion criteria for the study were as follows: (i) patient or his or her legal guardian voluntarily participates in and signs an informed consent form; (ii) male or female, aged 18 to 75 years; (iii) pathologically confirmed CD19+ B-cell malignancies, and patients met the following criteria for refractory or relapsed B-cell malignancies: (a) refractory/relapsed B-cell lymphoblastic leukemia (meeting one of the following): (1) recurrence within six months after first remission; (2) primary refractory disease which cannot achieve complete remission after two cycles of standardized chemotherapy regimen; (3) failure to achieve complete remission or relapse after one line or multiple lines of salvage chemotherapy; or (4) not suitable for hematopoietic stem cell transplantation (HSCT), abandonment of HSCT due to various restrictions, or relapse after HSCT; or (b) refractory/relapsed B-cell lymphoma (meeting one of the following three items plus item four): (1) tumor shrinkage less than 50% or disease progression after four cycles of standard chemotherapy or (2) achieved complete remission after standard chemotherapy, but relapsed within six months or (3) two or more relapses after complete remission plus (4) subjects must have received adequate treatment in the past, including anti-CD20 monoclonal antibody and combination chemotherapy with anthracyclines; (iv) having a measurable or evaluable lesion: (a) patients with lymphoma require a single lesion greater than or equal to 15 mm or two or more lesions greater than or equal to 10mm or (b) patients with leukemia require persistent positive or positive relapse of bone marrow MRD; (v) patient’s main organs functioning well: (a) liver function: ALT/AST less than or equal to 3 times the upper limit of normal (ULN) and total bilirubin less than two times ULN; (b) renal function: creatinine less than 220μmol/L; (c) pulmonary function: indoor oxygen saturation greater than or equal to 95% and (d) cardiac function: left ventricular ejection fraction (LVEF) greater than or equal to 50%; (vi) greater than or equal to two weeks since prior therapy at the time of enrollment, and the toxicity related to previous treatments returned to less than grade 1 (except for low grade toxicity such as alopecia); (vii) ECOG score less than or equal to two; and (viii) estimated survival time greater than or equal to three months.Overview

~~The exclusion~~We ~~criteria~~own ~~for~~certain ~~the study were as follows: (i) women who are pregnant or breastfeeding; (ii) women of child-bearing potential~~unregistered ~~and~~intellectual ~~all~~property ~~male~~rights ~~participants~~that ~~can’t~~we use ~~effective~~in ~~methods~~connection ~~of contraception for at least 12 months following infusion; (iii) patients fail to collect enough PBMC; (iv) patients~~ with ~~other~~our ~~uncontrolled diseases~~business, ~~such~~including asa ~~active~~common ~~infection;~~law ~~(v)~~trademark ~~active~~for ~~hepatitis~~Estrella™. BWe ~~or active~~also ~~hepatitis~~own C;certain ~~(vi)~~plasmids, ~~known~~cell ~~HIV~~lines, ~~positive~~and ~~patients;~~materials ~~(vii)~~related ~~patients~~to ~~with~~CD19 ~~active~~and ~~autoimmune~~CD22 ~~diseases~~in ~~requiring~~connection ~~systemic immunosuppressive therapy; (viii) participants~~ with ~~other~~the ~~active~~ARTEMIS® ~~malignancies~~platform, ~~(except~~and trade ~~non-melanoma~~secrets ~~skin cancer~~ and ~~cervical~~other ~~cancer)~~intellectual ~~within~~property ~~three~~rights ~~years;~~related ~~(ix)~~thereto. ~~patients with~~A ~~severe~~material ~~mental~~portion ~~disorder or disorders~~ of ~~consciousness;~~the ~~(x)~~intellectual ~~patients~~property ~~who~~we ~~need~~use ~~immediate~~in ~~treatment~~our ~~to control tumor progression or~~business ~~relieve~~is ~~tumor burden; (xi) patients participated~~ in-licensed ~~other~~from ~~clinical~~Eureka, ~~treatments~~as ~~within~~described ~~six weeks; (xii) patients with drug addiction; and (xiii) patients with poor treatment compliance~~below.

~~Endpoints~~License Agreement with Eureka

~~The primary~~On ~~objectives~~June ~~were~~28, ~~incidence~~2022, ofwe ~~adverse~~entered ~~events~~into ~~(AEs)~~the License Agreement with Eureka and ~~ORR~~Eureka Therapeutics (Cayman), Inc. ~~CRS~~(the ~~and~~“License ~~ICANS~~Agreement”) ~~were~~, ~~graded~~under ~~using~~which Eureka granted the ~~American~~Company ~~Society~~an ~~for~~exclusive ~~Transplantation~~license to certain intellectual property within all territories worldwide, excluding Greater China and ~~Cellular~~the ~~Therapy~~Association ~~consensus~~of ~~grading~~Southeast Asian Nations (ASEAN) countries (“Licensed Territory”). ~~All~~This ~~other~~agreement ~~AEs~~provides ~~were~~the ~~graded~~Company ~~according~~with the right to certain functions related to any T-cell products that incorporate (a) the ~~Common~~ARTEMIS® ~~Terminology~~platform ~~Criteria~~and ~~for~~(b)(i) ~~Adverse~~the ~~Events.~~CD19 ~~Dose-limiting~~binder and/or (ii) the CD22 binder ~~toxicities~~identified in the License Agreement (~~DLTs~~the “Licensed Product”). ~~were~~The ~~defined~~License asAgreement ~~EB103-related~~provides ~~AEs~~that, ~~within~~during 30the ~~days~~term, ~~after~~Eureka grants ~~infusion~~Estrella ~~and~~an ~~included~~exclusive ≥license, ~~grade~~with 3the ~~cardiac~~right to grant sublicenses through multiple tiers to (a) make, ~~hepatic~~import, ~~pulmonary~~use, sell or offer ~~and~~to ~~renal~~sell ~~toxicities~~the Licensed Products, ~~and~~(b) ≥develop ~~grade~~the 3Licensed ~~CRS~~Products ~~and~~solely ~~ICANS~~for ~~that~~the ~~lasted~~purpose ~~over~~of 72obtaining ~~hours~~regulatory ~~after~~approval ~~treatment.~~of ~~Exceptions~~such toLicensed Products, ~~this~~(c) ~~definition~~commercialize ~~were~~such ~~not counted~~Licensed asproducts aand ~~DLT.~~(d) ~~Response~~manufacture ~~was~~the ~~assessed~~Licensed ~~using~~Products solely for developing the ~~Lugano~~Licensed ~~Criteria~~Products for the purposes of obtaining regulatory approval of such Licensed Products and for commercializing such Licensed Products.

The secondary objectives included Duration of Response (DoR), progression-free survival (PFS), overall survival (OS), and expansion and persistence of EB103 T-cells, and serum cytokines in the peripheral blood (PB) after infusion. PB refers to the blood circulating in the body’s blood vessels. DoR, PFS, and OS were defined per the revised response criteria for malignant lymphoma. Under the criteria, DoR is defined as from the time when criteria for response (CR or PR) are met, for which the event is the first documentation of relapse or progression. PFS is defined as the time from entry into a study until lymphoma progression or death as a result of any cause. OS is defined as the time from entry onto the clinical trial until death as a result of any cause. Only the first infusion was included in the main analyses of safety and efficacy. Exploratory endpoints included the safety and efficacy among patients retreated with EB103 T-cells.11

23Pursuant to the terms of the License Agreement, in partial consideration of Eureka’s grant of the rights and licenses to Estrella, Estrella agreed to pay Eureka a one-time, non-refundable, non-creditable payment of $1.0 million. As of December 31, 2025, $1.0 million has been paid to Eureka.

~~Imaging~~Eureka is eligible to receive up to five one-time development milestone ~~and~~payments ~~pathological~~from ~~examination~~Estrella in the aggregate amount of approximately $60.2 million if all five development milestones are achieved. Effective as of March 1, 2023, the parties further amended the License Agreement to provide that if any development milestone is achieved prior to the Closing of the Business Combination, the corresponding development milestone payment will not be due to Eureka until the Closing of the Business Combination.

~~F-fluorodeoxyglucose~~Eureka is also eligible to ~~positron~~receive ~~emission~~up ~~tomography-computed~~to ~~tomography~~four ~~(PET~~one-~~CT),~~time ~~computed~~sales ~~tomography~~milestone ~~(CT),~~payments ~~magnetic~~from ~~resonance~~Estrella ~~imaging~~based ~~(MRI),~~on ~~cerebrospinal fluid~~the ~~(CSF)~~aggregate ~~assessment,~~net ~~and~~sales ~~biopsies~~of ~~were~~all ~~performed~~Licensed Products by or on behalf of Estrella or any of its affiliates or sublicensees in the ~~patients~~Licensed ~~following~~Territory during any consecutive 12-month period in the ~~Lugano~~aggregate amount ~~Criteria~~of $225.0 ~~The~~million ~~assessments~~if all four sales milestones are achieved. Each sales milestone payment will only be paid once, regardless of the ~~tumor~~number ~~tissue~~of ~~were~~Licensed Products or the number of times a given sales milestone has been achieved. Estrella is also responsible (with input ~~conducted~~from Eureka) for the preparation, filing, prosecution, and ~~reviewed~~maintenance byof ~~two~~the ~~independent~~patent ~~pathologists~~rights, including all associated costs.

~~Statistical~~In addition, during the applicable royalty term, Estrella will be required ~~analyses~~to pay to Eureka royalties in the amount of a single digit percentage of the aggregate Net Sales of all Licensed Products sold by or on behalf of Estrella or its affiliates or sublicensees in the Licensed Territory during a calendar year. Such amount is subject to certain reductions (not to exceed 50% of the amount otherwise payable) due to the expiration of valid claims of a licensed patent right in a given country in the Licensed Territory or due to 50% or greater declines in sales as a result of generic product competition in a given country in the Licensed Territory. The royalty term begins upon the first commercial sale of a Licensed Product in a country in the Licensed Territory and continues until the later of (a) the date on which such Licensed Product is no longer covered by a valid claim within Eureka’s licensed patent rights in such country, (b) the expiration of all exclusive marketing rights or data protection or other exclusivity rights (other than patent rights) conferred by any regulatory authority with respect to a product in a country or jurisdiction that prohibits the commercialization of a generic product, including orphan drug exclusivity or pediatric exclusivity for such Licensed Product in such country, and (c) 12 years after the first commercial sale of such Licensed Product in such country.

~~All eight~~The ~~patients~~License ~~who~~Agreement ~~received~~will ~~the~~remain ~~infusion were included~~ in ~~the~~effect ~~analyses.~~on ~~Descriptive~~a ~~statistics~~Licensed ~~include~~Product-by-Licensed Product ~~means~~and ~~with~~country-by-country ~~95%~~basis, ~~confidence~~until ~~interval (CI)~~the orexpiration ~~medians~~of ~~with~~the ~~minimum~~royalty ~~and~~term ~~maximum~~for ~~(range)~~a ~~for~~Licensed ~~continuous~~Product ~~variables~~in ~~and~~a ~~counts~~country and ~~percentages~~will ~~for~~finally ~~categorical~~expire upon ~~variables.~~expiration ~~Missing data~~of ~~were~~the ~~not~~royalty ~~imputed.~~term ~~Continuous~~for ~~variables~~the ~~were~~final ~~compared~~Licensed ~~using~~Product. ~~paired~~Estrella ~~t-test~~may ~~when~~terminate the ~~data~~License ~~were~~Agreement ~~normally~~for ~~distributed.~~any ~~Otherwise,~~reason ~~the~~or no ~~Wilcoxon~~reason ~~test~~upon ~~was~~120 ~~used.~~days’ ~~DoR,~~prior ~~PFS,~~written ~~OS,~~notice ~~and~~to ~~associated~~Eureka. ~~95%~~Either CIparty ~~were~~has ~~determined~~the byright ~~the~~to ~~Kaplan~~terminate —the ~~Meier~~License ~~methods~~Agreement ~~and~~upon ~~compared~~material breach ~~with~~of the ~~log-rank~~ ~~test~~other ~~between~~party ~~subgroups.~~that ~~Analysis~~is ~~was~~not ~~performed~~cured ~~using~~within ~~Graphpad~~90 ~~Prism~~days ~~version~~after ~~8.0.~~the Pbreaching ~~values~~party ~~less~~receives ~~than~~written ~~0.05~~notice ~~(two-tailed)~~of ~~were~~such ~~considered~~breach from the non-breaching ~~significant~~party.

~~Tolerability~~On January 30, 2023, one development milestone payment in the amount of $50,000 related to the submission of EB103 to the FDA was earned by Eureka under the Agreement, which was paid on October 10, 2023. With the dosing of the first patient in July 2024 in the STARLIGHT-1 clinical trial, the development milestone pursuant to Section 8.2.1 (First Patient Dosed in the First Clinical Trial of a Licensed Product) in the Licensing Agreement with Eureka was met. As a result, Estrella made a payment of $50,000 to Eureka for reaching this milestone. As of December 31, 2025, nine patients have been dosed in the STARLIGHT-1 clinical trial. No other development milestone, sales milestone, or royalty payment has been earned as of December 31, 2025, as we do not have any product candidates approved for sale and have not generated any revenue from product sales.

~~All eight~~Eureka ~~patients~~Patent experienced adverse events (AEs) of grade 3 or higher. Three patients (37.5%) experienced grade 1 CRS that resolved spontaneously, with a median onset of four days (range: two to nine days) and a median duration of three days (range: one to eight days). Patient Two developed grade 3 ICANS after CRS, which manifested as confusion, barylalia, tremor, and agitation, but Patient Two responded to treatment with corticosteroids. ICANS occurred on the ninth day following infusion and lasted for nine days; thus, it was judged as a DLT. Apart from Patient Two, DLTs were not observed in the patient cohort. Patient Eight had a pulmonary infection on day 15 that lasted for four days after antibiotic treatment. Other infectious complications were not observed within one month due to the administration of antiviral and antifungal preventative medicines in these patients. Patient Four had lymphoma involvement in the intestinal tract and suffered an acute intestinal perforation, resulting in emergency surgery 16 days after infusion. Ultimately, all acute AEs were reversible with supportive treatment.Information

~~Tocilizumab, an anti-IL6R antibody, which can alleviate CRS. Was not administered.~~ The ~~increase~~patents inowned ~~inflammatory~~by ~~cytokines~~Eureka ~~from~~relating ~~baseline~~ to ~~peak~~EB103 ~~were~~and ~~modest,~~EB104 ~~except~~cover ~~for~~compositions ~~the elevation~~ of ~~IL6R levels in Patients Two~~matter, ~~Four~~uses, and ~~Eight,~~processes ~~which~~in ~~were~~various ~~greater~~jurisdictions, ~~than~~including ~~tenfold~~Australia, ~~the~~Canada, ~~baseline~~Europe, ~~value. This~~Israel, ~~elevation generally coincided with serum C-reactive protein levels and was concurrent with the onset of CRS and ICANS in Patient~~India, ~~Two~~Japan, ~~intestinal~~Korea, ~~perforation~~Mexico, inNew ~~Patient~~Zealand, ~~Four~~Russia, and ~~pulmonary~~the ~~infection~~United ~~in Patient Eight~~States. ~~Therefore,~~These ~~the~~patents ~~study~~expire ~~concluded~~on ~~that~~October ~~there~~21, ~~might be alternative causes for the elevated inflammatory markers in these three patients other than the EB103 treatment~~2036.

Blood-based toxicities were the most common AEs, including low levels of white blood cells (neutropenia) and low levels of platelets of grade 3 or 4 in seven (87.5%), six (75%), and two (25%) patients after EB103 infusion, respectively. Severe anemia was not observed. The preconditioning regimens exhibited significant adverse effects on leucocytes, lymphocytes, monocytes (all types of blood cells), and hemoglobin levels, but not on platelets and neutrophils (a type of white blood cell). The median time from infusion to recovery of ≤ grade 2 neutropenia and leukopenia (low levels of leukocytes) was 13 days (range, four to 26) days and 13 (range, four to 26) days, respectively. Delayed recovery from severe thrombocytopenia (platelet deficiency) was observed in Patient Two for over two months.12

~~B-cell aplasia,~~Government defined as CD19+ B-cells representing less than three percent of lymphocytes in peripheral blood (PB), was observed in all patients at baseline. The preconditioning chemotherapy exhibited significant inhibition on T cells and NK cells (another type of immune cell) in the PB, and EB103 cells showed effects on T cells. CD4+ T cells and CD8+ T cells decreased significantly after the preconditioning chemotherapy and expanded on day 14 after EB103 infusion. Three patients (37.5%) had preexisting hypogammaglobulinemia, a disorder caused by low serum immunoglobulin (a type of antibody) levels, defined as serum IgG less than 800 mg/dL, IgM less than 50 mg/dL, and IgA less than 100 mg/dL. Serum IgG, IgM, and IgA are all types of antibodies. The reduction of serum IgG, IgA, and IgM after EB103 infusion was observed in seven (87.5%), eight (100%), and six (75%) patients, respectively. The recovery of serum IgG, IgA, and IgM to their normal levels during follow-up was observed in three (42.8%), two (25%), and four (66.7%) patients respectively.Regulation

24The U.S. Food and Drug Administration, or FDA, and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, record keeping, approval, advertising, promotion, marketing, sampling post-approval monitoring and post-approval reporting of biologics such as those we are developing. Any product candidates that we develop must be approved by the FDA before they may be legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in those foreign countries. Generally, our activities in other countries will be subject to regulation that is similar in nature and scope as that imposed in the United States, although there can be important differences.

~~Patient One experienced two treatable long-term AEs: viral encephalitis at month 18 and MOG + encephalomyelitis at month 30~~U. ~~At the time of these AEs, EB103 cells were undetectable in the patient~~S. ~~As such, the authors of the study believed that these delayed AEs were not directly caused by EB103 cells.~~Regulation

~~Efficacy~~Biologic Development Process

In the United States, biological products are subject to regulation under the ~~clinical~~Federal ~~study~~Food, ~~clinical~~Drug, ~~responses~~and ~~were~~Cosmetic ~~achieved~~Act, bythe ~~87.5%~~Public ofHealth ~~patients~~Service Act, ~~with~~and other ~~75%~~federal, ~~achieving~~state, CRlocal and ~~62.5%~~foreign ~~having~~statutes ~~ongoing~~and CRtheir implementing regulations. The ~~Kaplan-Meier estimated~~process OSof atobtaining ~~12-36~~regulatory ~~months~~approvals and ~~was~~the ~~75.0%~~subsequent ~~(95%~~compliance ~~CI:~~with ~~31.5-93.1).~~appropriate ~~The~~federal, ~~Kaplan-Meier~~state, ~~estimated~~local ~~progression-free~~and ~~survival~~foreign ~~(PFS)~~statutes atand ~~12-36~~regulations ~~months~~require the expenditure of ~~was~~substantial ~~62.5%~~time ~~(95%~~and ~~CI:~~financial 22resources.~~9-86.1),~~ ~~with~~The aprocess ~~DoR~~required atby ~~12-36~~the ~~months~~FDA ofbefore ~~71.4%~~biologics ~~(95%~~may CIbe marketed in the United States generally involves the following:~~25.8-92.0).~~

~~Patient One~~● ~~with~~completion ~~primary central nervous system lymphoma had been refractory to eight previous lines~~ of ~~therapies.~~preclinical ~~She~~laboratory ~~experienced~~tests aand ~~continuing CR~~animal ~~for~~studies ~~over~~performed ~~three years after EB103 infusion. Numerous EB103 cells were detectable~~ in ~~both~~accordance the PB and CSF after infusion (See Figure 4B below), indicating that EB103 cells could sufficiently traffic from the periphery to the central nervous system. Patient Two had extensive lesions and attained a quick PR at month one, but the diseases progressed at month two. A second tissue biopsy demonstrated DLBCL. The patient received a second infusion with ~~poor expansion, and~~ the diseases progressed on day 14; consequently, the patient withdrew from the study for other salvage therapy. Patient Three had two major lesions in the right eyeball and the pelvic cavity, and she attained a PR on day 14 and an ongoing CR for over two years. Patient Four achieved a CR at month two and kept CR for over two years. Patient FiveFDA’s ~~EB103~~Good ~~cells~~Laboratory ~~exhibited~~Practice ~~rapid clearance and durable control of a bulky tumor. Patient Six~~requirements, ~~with~~or lymphoma mainly in the abdominal cavity, did not respond to EB103 treatment and withdrew from the study at month two. Patient Seven had extensive lesions mainly in the lung and the abdominal cavity and attained a CR at month five. However, new lesions appeared at month nine, and a second infusion failed. Patient Eight had two lymph node lesions in the left heart diaphragm angle and retroperitoneal space, and obtained a CR on day 24, and kept durable CR at month 24.GLP;

~~Secondary Infusion~~● submission to the FDA of an IND, which must become effective before clinical trials may begin;

~~Patients Two,~~● ~~Five~~approval ~~and~~by ~~Seven~~an ~~received~~institutional areview ~~second~~board, ~~infusion.~~or ~~Patients~~IRB, ~~Two~~or ~~and~~ethics ~~Seven~~committee ~~received a second infusion as salvage therapy after disease progression but did not respond. Patient Five maintained CR according to the Lugano Criteria~~ at ~~month~~each ~~six,~~clinical ~~but~~site ~~PET-CT~~before ~~scans showed minimal residual lesions in~~ the ~~hepatogastric~~trial ~~space-pancreatic~~is head. Despite low levels of EB103 cells in peripheral blood, Patient Five received a repeated infusion without preconditioning chemotherapy and experienced self-limiting severe neutropenia, leukopenia, and thrombocytopenia. Apart from hematologic toxicities observed in Patients Two and Five, no other adverse events were reported.commenced;

~~Expansion~~ ● performance of adequate and ~~persistence~~well-controlled human clinical trials according to the FDA’s regulations commonly referred to as good clinical practice, or GCP, regulations and any additional requirements for the protection of ~~EB103~~human research subjects and their health information to establish the safety, purity, and potency of the proposed biologic product candidate for its intended purpose;

~~After being~~● ~~infused~~preparation ~~into~~of ~~a patient, EB103 cells showed maximum expansion between nine~~ and 21submission ~~days. At their peak, these cells reached a median count of 318 cells per milliliter (mL) of PB, with a range of 32~~ to ~~4,308,109 cells/mL. The number of EB103 cells in PB was determined through flow cytometry, which is a technique used to measure~~ the ~~characteristics~~FDA of ~~cells. Additionally, quantitative polymerase chain reaction (qPCR) measurements showed~~ a ~~median~~Biologics ~~count~~License ~~of 76~~Application,~~897~~ ~~copies~~or ~~per microgram (µg) of genomic DNA with a range of 21~~BLA,~~278~~ ~~to 273,032~~after ~~copies/µg.~~completion ~~qPCR is a method used to measure the amount~~ of ~~specific~~all ~~DNA~~pivotal ~~sequences~~clinical in a sample. The median area under the curve from day 0 to day 28 post-infusion was calculated to be 585,493.5 copies/µg × days. This value represents the total amount of EB103 cells present in the patient over time. At the end of the first year following infusion, EB103 cells were still detectable in PB in half of the patients. However, expansion was poor during second infusions.trials;

~~Conclusion~~● satisfactory completion of an FDA Advisory Committee review, if applicable;

~~The authors~~● ~~of the study concluded that the data suggest that EB103 T-cells represent~~ a ~~novel~~determination ~~and~~by ~~potentially potent therapeutic option for~~ the ~~patient~~FDA ~~population~~within ~~being~~60 ~~studied.~~days ~~However,~~of ~~the~~its ~~authors~~receipt ~~noted~~of ~~that the findings were limited by the small sample size, and~~ a ~~recommended phase~~BLA ~~2 dose was not identified. The authors also stated that larger and multi-center trials are needed~~ to ~~verify~~file the ~~long-term~~application ~~safety and~~for ~~efficacy of CD19-specific T cells in RR DLBCL.~~review;

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

~~Figures~~● potential FDA audit of the nonclinical and clinical study sites that generated the data in support of the BLA; and

~~Below are~~● ~~four~~FDA ~~figures~~review ~~from~~and approval of the ~~clinical~~BLA ~~study~~to ~~report~~permit ~~related~~commercial tomarketing of the ~~findings~~product ~~described~~for ~~above~~particular indications for use in the United States.

~~Changes~~Before testing any biological product candidate in ~~serum~~humans, ~~inflammatory~~the ~~markers~~product ~~within~~candidate 1enters ~~month~~the ~~after~~preclinical ~~EB103~~testing ~~infusion~~stage. Preclinical tests, also referred to as nonclinical studies, include laboratory evaluations of product chemistry, toxicity and formulation, as well as animal studies to assess the potential safety and activity of the product candidate. The conduct of the preclinical tests must comply with federal regulations and requirements including GLPs.

(A) Fold changes of inflammatory cytokines from baseline to peak (n = 10). Patient Five received the repeated infusions in the outpatient department and data were not available. (B-I) Changes in the serum interleukin (IL)-6, C-reactive protein (CRP), IL-2, IL-4, IL-10, interferon-γ (IFN-γ), tumor necrosis factor-α (TNF-α) and ferritin in individuals. (J) Changes in serum IL-6, CRP, and EB103 counts and copies in peripheral blood (PB) of Patients Two, Four, and Eight.13

26Prior to beginning the first clinical trial with a product candidate in the United States, we must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an investigational new drug to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies. Some preclinical testing may continue even after the IND is submitted. The IND also includes 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. 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.

~~Swimmer’s~~In addition to the ~~plot~~submission of an IND to the FDA before initiation of a clinical trial in the United States, certain human clinical trials involving recombinant or synthetic nucleic acid molecules are subject to oversight of institutional biosafety committees, or IBCs, as set forth in the National Institutes of Health, or NIH, Guidelines for Research Involving Recombinant DNA Molecules, or the NIH Guidelines. Specifically, under the NIH Guidelines, supervision of human gene transfer trials includes evaluation and ~~long-term~~assessment ~~outcomes~~by an IBC, a local institutional committee that reviews and oversees research utilizing recombinant or synthetic nucleic acid molecules at that institution. The IBC assesses the safety of the ~~treated~~research ~~patients~~and identifies any potential risk to public health or the environment, and such review may result in some delay before initiation of a clinical trial. While the NIH Guidelines are not mandatory unless the research in question is being conducted at or sponsored by institutions receiving NIH funding of recombinant or synthetic nucleic acid molecule research, many companies and other institutions not otherwise subject to the NIH Guidelines voluntarily follow them.

(Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A) separate submission to the existing IND must be made for each successive ~~Swimmer’s~~clinical ~~plot~~trial conducted during product development and for any subsequent protocol amendments. Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site, and must monitor the study until completed. An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the ~~eight~~risks ~~treated~~to ~~patients~~individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. ~~(B-D)~~The ~~Kaplan~~IRB —also ~~Meier~~approves ~~estimates~~the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial 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 OSclinical study sponsor, ~~PFS~~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 ~~DoR~~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 studies and clinical study results to public registries.

27For purposes of BLA approval, human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

~~Clinical responses~~● Phase 1 — The investigational product is initially introduced into healthy human subjects or patients with the target disease or condition. These studies are designed to test the safety, dosage tolerance, absorption, metabolism, and distribution of ~~EB103~~the ~~cells~~investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. In the case of some products for severe or life-threatening diseases, such as cancer, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.

~~(A) Changes~~● inPhase ~~cranial~~2 ~~MRI~~— ~~scans~~The ofinvestigational ~~Patient~~product ~~One.~~is ~~(B)~~administered ~~EB103~~to ~~copies~~a ~~per~~limited ~~microgram~~patient ~~(µg)~~population ofwith ~~genomic~~a ~~DNA~~specified indisease PBor ~~and~~condition ~~CSF~~to ~~and~~evaluate ~~body~~the ~~temperature changes~~preliminary inefficacy, ~~Patient~~optimal ~~One~~dosages, ~~within~~dose ~~one~~tolerance, ~~month~~and ~~after~~dosing ~~infusion.~~schedule ~~(C)~~and ~~Changes~~to inidentify ~~PET-CT~~possible ~~scans~~adverse ofside ~~Patient~~effects ~~Two~~and safety risks. ~~(D)~~Multiple ~~Changes~~Phase in2 ~~ocular~~clinical ~~enhanced~~trials ~~MRI and~~may ~~abdominal-enhanced~~be CTconducted ofto ~~Patient~~obtain ~~Three.~~information ~~(E)~~prior ~~Changes~~to inbeginning ~~PET-CT~~larger ~~scans~~and ofmore ~~Patient~~expensive ~~Seven~~Phase 3 clinical trials.

28● Phase 3 — The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of a BLA.

~~In vivo kinetics of EB103 cells~~14

~~(A) EB103~~In ~~expansion~~some ~~and~~cases, ~~persistence were measured as copies per microgram (µg) of~~ the ~~genomic~~FDA ~~DNA~~may require, byor ~~qPCR~~companies inmay ~~the~~voluntarily ~~eight~~pursue, ~~treated~~additional ~~patients within~~clinical ~~one~~trials ~~year.~~after ~~The~~a ~~detectable~~product ~~threshold~~is ~~was~~approved ~~100~~to ~~copies~~gain ~~per~~more µginformation ofabout the product ~~genomic~~in ~~DNA. The black arrow indicates~~ the ~~second~~intended ~~infusion. (B)~~therapeutic ~~The~~indication, ~~violin~~particularly ~~plot~~for oflong-term ~~peak~~safety ~~EB103~~follow-up. ~~cells~~Completion ~~per milliliter~~ of PBthese ~~(cells/mL~~so-called ~~PB)~~Phase as4 ~~measured~~studies may byalso ~~flow~~be ~~cytometry,~~made ~~peak~~a ~~copies~~condition ~~per~~to µgapproval of ~~genomic~~ ~~DNA (copies/µg DNA) as measured by qPCR and area under~~ the ~~curve from 0 to 28 days after infusion (AUC0 – 28d)~~BLA.

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

~~Pursuant to~~BLA ~~the~~Submission ~~Services Agreement~~ and ~~Statement~~Review ofby ~~Work #001, among other services, Eureka agreed to provide Estrella with access to Eureka’s T-cell manufacturing and lentiviral vector (LVV) processes in connection with~~ the IND application and clinical trials for EB103. See “— Material Agreements — Services Agreement and Statement of Work #001” below for additional information regarding the terms of the agreements.FDA

29Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, nonclinical studies and clinical trials are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications. The BLA must include all relevant data available from preclinical and clinical studies, including negative or ambiguous results as well as positive findings, together with detailed information relating to the product’s chemistry, manufacturing, controls, and proposed labeling, among other things. Data can come from company-sponsored clinical studies intended to test the safety and effectiveness of a use of the product, or from a number of alternative sources, including studies initiated by independent investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and effectiveness of the investigational drug product to the satisfaction of the FDA. The submission of a BLA requires payment of a substantial application user fee to the FDA, unless a waiver or exemption applies.

~~Strengths~~Within 60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before the FDA accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and ~~Advantages~~may request additional information. In this event, the BLA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing.

~~Eureka~~Once a BLA has been accepted ~~developed~~for filing, the ~~ARTEMIS®~~FDA’s ~~platform~~goal inis ~~response~~ to ~~significant~~review ~~tolerability~~standard ~~issues~~applications within ten months after the filing date, ~~including~~or, ~~potentially~~if ~~fatal~~the ~~side~~application ~~effects~~qualifies ~~CRS~~for ~~and~~priority ~~ICANS~~review, ~~observed~~six months after ~~CAR-T-cell~~the ~~infusions~~FDA inaccepts ~~patients~~the ~~with~~application ~~hematological~~for ~~cancers~~filing. WeIn ~~believe~~both ~~that~~standard and priority reviews, the ~~ARTEMIS®~~review process ~~platform~~may also be extended by FDA requests for additional information or clarification. The FDA reviews a BLA to determine, among other things, whether a product is safe, pure, and ~~our~~potent ~~EB103~~and ~~T-cell~~the ~~Therapy~~facility ~~are~~in ~~superior~~which it is manufactured, processed, packed, or held meets standards designed to ~~current~~assure ~~T-cell~~the ~~therapy~~product’s ~~technologies~~continued ~~based~~safety, purity and potency. The FDA may also convene an advisory committee to provide clinical insight on ~~three~~application ~~key~~review ~~features:~~questions. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that 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.

Key Features				Advantage
Antibody-based target recognition				The ability to achieve high specificity and binding affinity to intended cancer target when compared to TCRs.
AbTCR includes portions of a human TCR				The AbTCR associates with the endogenous CD3 complex enabling the AbTCR to use the same activation and regulatory signaling pathways employed by natural TCRs. This feature may lead to a decreased risk of side effects in patients.
Co-stimulation provided as a separate molecule				The AbTCR construct does not include an intracellular signaling domain covalently-linked to a co-stimulatory domain, and thus has the potential to eliminate T-cell hyperactivation and consequently, lower the risk of CRS and ICANS commonly observed with CAR-T therapy.

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

In addition to the advantages provided above, we believe that the decreased risks of side effects of our EB103 T-cells have the potential to allow for patients to receive treatments in locations other than dedicated cancer centers. This would allow for more patients to be able to receive EB103 T-cells and would ultimately decrease the costs associated with monitoring for side effects following treatment, hospital stays, and other miscellaneous expenses associated with current treatments.15

~~Potential~~After the FDA evaluates a ~~Market~~BLA and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response Letter, or CRL. An approval letter authorizes commercial marketing of the product with specific prescribing information for specific indications. A CRL indicates that the review cycle of the application is complete, and the application will not be approved in its present form. A CRL will describe all of the deficiencies that the FDA has identified in the BLA, except that where the FDA determines that the data supporting the application are inadequate to support approval, the FDA may issue the CRL without first conducting required inspections, testing submitted product lots, and/or reviewing proposed labeling. In issuing the CRL, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional information or clarification. The FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product. If a CRL is issued, the sponsor must resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw the application. Even if such data and information are submitted, the FDA may decide that the BLA does not satisfy the criteria for approval.

~~According~~If regulatory approval of toa ~~Vision~~product ~~Research~~is ~~Reports~~granted, such approval will be granted for particular indications and may entail limitations on the ~~cancer~~indicated ~~immunotherapy~~uses ~~market~~for ~~size~~which such isproduct ~~expected~~may tobe ~~grow~~marketed. atFor example, the FDA may approve the BLA with a ~~CAGR~~Risk Evaluation and Mitigation Strategy, or REMS, to ensure the benefits of ~~10.6%~~the ~~during~~product outweigh its risks, or otherwise limit the ~~forecasted~~scope ~~period~~ of ~~2022~~any approval. A REMS is a safety strategy implemented to ~~2030~~manage a known or potential serious risk associated with a product and isto ~~expected~~enable patients to ~~grow~~have continued access to ~~$130.6~~such ~~billion~~medicines by inmanaging ~~2030~~their ~~compared~~safe use, and could include medication guides, physician communication plans or elements to ~~$60~~assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.1 ~~billion~~The inFDA ~~2020~~also may condition approval on, among other things, changes to proposed labeling or the development of adequate controls and specifications. ~~Generally~~Once approved, ~~T-cell~~the ~~treatments~~FDA ~~for~~may withdraw the ~~blood~~product ~~cancers~~approval if compliance with pre- and post-marketing requirements is ~~covered~~not bymaintained ~~insurance~~or if problems occur after the product reaches the marketplace. The FDA may require one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization, and ~~each~~may ~~treatment~~limit ~~costs~~further anmarketing ~~average~~of the product based on the results of ~~$400,000~~these post-marketing studies.

30Expedited Development and Review Programs

~~EB104~~The FDA offers a number of expedited development and review programs for qualifying product candidates. For example, new biological products are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. Fast track designation applies to the combination of the product and the specific indication for which it is being studied. The sponsor of a new biologic may request that the FDA designate the biologic as a fast track product at any time during the clinical development of the product. The sponsor of a fast track product has opportunities for more frequent interactions with the applicable FDA review team during product development and, once a BLA is submitted, the product candidate may be eligible for priority review. A fast track product may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the BLA.

~~EB104 T-cells~~A ~~are~~product ~~engineered~~candidate intended to ~~express~~treat ~~ARTEMIS®~~a ~~cell~~serious ~~receptors~~or ~~(i.e., the AbTCR and co~~life-~~stimulatory~~threatening ~~molecule)~~disease onor ~~their~~condition ~~cell surfaces~~may inalso abe ~~manner~~eligible ~~similar~~for tobreakthrough ~~EB103.~~therapy ~~Like~~designation ~~EB103, both the AbTCR and co-stimulatory molecule of EB104 are designed~~ to ~~recognize~~expedite ~~and~~its ~~bind~~development ~~the CD19 antigen. In addition, the AbTCR in EB104 T-cells recognizes~~ and ~~binds the CD22 antigen as well~~review. ~~Once~~A ~~infused,~~product ~~EB104~~candidate ~~T-cells are~~can ~~able~~receive tobreakthrough ~~engage~~therapy ~~CD19-~~designation ~~and~~if ~~CD22-positive~~preliminary ~~cancer~~clinical ~~cells.~~evidence ~~The~~indicates ~~AbTCR expressed on~~ that the ~~EB104~~product ~~T-cell by its nature associates~~candidate, ~~via~~alone ~~its~~or ~~effector domain~~in ~~(γδ~~combination ~~TCR chains),~~ with ~~the~~one ~~endogenous~~or ~~CD3~~more ~~complex.~~other ~~When~~drugs ~~the~~or ~~AbTCR binds to its target~~biologics, ~~CD19~~may ordemonstrate ~~CD22,~~substantial ~~expressed~~improvement ~~on the~~over ~~cancer~~existing ~~cell,~~therapies ~~AbTCR/CD3~~on ~~complex-mediated~~one ~~signal~~or ~~transduction~~more ~~within~~clinically ~~the~~significant ~~EB104~~endpoints, ~~T-cell~~such isas ~~initiated.~~substantial ~~This~~treatment ~~signal~~effects ~~transduction~~observed ~~process~~early ~~ultimately leads~~in toclinical ~~the activation of the EB104 T-cell~~development. ~~A second “enhancement” signal is generated when the co-stimulatory molecule~~ ~~expressed~~The ondesignation ~~the~~includes ~~EB104~~all ~~T-cells~~of ~~binds to its target, CD19, expressed on~~ the ~~cancer~~fast ~~cell.~~track ~~Although~~program ~~the co-stimulatory molecule expressed on EB104 T-cells cannot bind to CD22~~features, ~~EB104~~as ~~T-cells~~well ~~are~~as ~~able~~more tointensive ~~engage~~FDA ~~CD19~~interaction orand ~~CD22~~guidance ~~(with~~beginning ~~the~~as ~~AbTCR) while the co-stimulatory molecule~~early ~~binds~~as toPhase ~~CD19.~~1 ~~Like~~and ~~EB103,~~an ~~the~~organizational ~~main~~commitment ~~function~~to ofexpedite the ~~co-stimulatory~~development ~~molecule is to “boost” AbTCR signaling, resulting in increased expansion~~ and ~~survival~~review of ~~EB104 T-cells inside~~ the ~~body~~product candidate, ~~and~~including ~~the~~involvement ~~co-stimulatory molecule has also been optimized to provide EB104 T-cells~~of ~~with~~senior ~~enhanced T-cell activation~~managers. ~~In summary, EB104 T-cells seek out CD19 and CD22-positive cancer cells, bind to these cells, and destroy them.~~

Despite impressive outcomes of CAR-T cell treatments over the past five years, more than 50% of patients treated with CD19-targeted CAR-T cell therapy experience progressive disease. In addition, many patients treated with CD19-target CAR-T cell therapies subsequently show absent or low CD19. Further, disease progression associated with loss of cell surface CD19 has been reported in 30 – 95% of relapses after CD19-targeted CAR-T therapy in B-cell acute lymphoblastic leukemia. We believe that this obstacle can be addressed by dual-targeting both CD19 and CD22 with EB104. For patients that may exhibit lower CD19 surface density, EB104 has the potential to bind to both CD19 and CD22 to increase the odds of effective T-cell therapy.16

~~EB104~~Any marketing application ~~Preclinical~~for ~~Data~~a biologic submitted to the FDA for approval, including a product candidate with a fast track designation and/or breakthrough therapy designation, may be eligible for other types of FDA programs intended to expedite development and review, such as priority review and accelerated approval. A product candidate is eligible for priority review if it has the potential to provide safe and effective therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment, diagnosis or prevention of a disease compared to marketed products. The FDA will attempt to direct additional resources to the evaluation of an application for a new biological product designated for priority review in an effort to facilitate the review. For original BLAs, priority review designation means the FDA’s goal is to take action on the marketing application within six months of the 60-day filing date (as compared to ten months under standard review).

~~To test~~Additionally, ~~the~~product ~~anti-tumor~~candidates studied ~~activity~~for oftheir ~~EB104~~safety ~~towards~~and ~~low~~effectiveness orin notreating ~~CD19~~serious ~~surface~~or ~~expression~~life-threatening ~~cancer~~diseases ~~cells,~~or inconditions ~~2019,~~may ~~Eureka~~receive ~~constructed~~accelerated ~~a Nalm-6-CD19ko~~approval ~~cell~~upon ~~line,~~a ~~which~~determination isthat athe ~~B-cell~~product ~~precursor~~has ~~leukemia~~an ~~cell~~effect ~~line,~~on ~~with~~a ~~the~~surrogate ~~“knockout”~~endpoint ofthat ~~CD19~~is ~~gene~~reasonably ~~expression.~~likely ~~This~~to ~~cell~~predict ~~line~~clinical ~~mimics~~benefit, or ~~patients’~~on ~~diminished~~a ~~CD19~~clinical ~~surface~~endpoint ~~expression~~that ~~after~~can ~~CD19-directed~~be ~~immunotherapies.~~measured Toearlier ~~confirm~~than ifirreversible ~~EB104~~morbidity ~~T-cells~~or ~~have~~mortality, ~~the~~that ~~potential to~~is ~~overcome~~reasonably ~~CD19~~likely ~~antigen~~to ~~loss~~predict inan effect ~~cancer~~on ~~cells,~~irreversible ~~Eureka~~morbidity ~~tested~~or ~~the~~mortality ~~activity~~or ofother ~~EB104~~clinical asbenefit, ~~well~~taking asinto ~~EB103~~account ~~cells~~the inseverity, ~~mice~~rarity ~~using~~or ~~NSG™~~prevalence ~~xenograft~~of the ~~models~~condition ~~(which~~and ~~are~~the ~~highly~~availability ~~immunodeficient~~or ~~mice)~~lack of ~~leukemia~~alternative ~~with~~treatments. ~~Nalm-6~~As ~~and Nalm-6-CD19ko cells with~~ a ~~bioluminescence~~condition ~~reporter.~~of ~~The~~accelerated ~~total flux~~approval, ~~from~~ the ~~bioluminescence~~FDA ~~reporter~~will ~~measured~~generally require the ~~tumor~~sponsor ~~growth.~~to Inperform ~~the~~adequate ~~experiments~~and ~~shown~~well-controlled ~~below,~~post-marketing ~~Eureka~~clinical ~~tested~~studies ~~EB104,~~to ~~EB103,~~verify and ~~mock T-cells~~describe ~~head-to-head,~~the ~~against~~anticipated ~~the~~effect ~~NSG™~~on ~~xenograft~~irreversible morbidity ~~model,~~or ~~with~~mortality ~~six~~or ~~mice~~other ~~for~~clinical ~~each~~benefit. ~~treatment~~Products ~~group,~~receiving ~~respectively.~~accelerated ~~Four~~approval ~~days~~may ~~before the~~be ~~T-cells~~subject ~~were~~to ~~infused,~~expedited ~~0.5x106~~withdrawal ~~leukemia~~procedures if ~~cells~~the ~~Nalm-6~~sponsor ~~(expressing~~fails ~~both~~to ~~CD19~~conduct ~~and~~the ~~CD22)~~required ~~with~~post-marketing ~~bioluminescence~~studies ~~reporter~~or ~~were~~if ~~injected~~such ~~into mice.~~studies ~~Four~~fail ~~days~~to ~~later,~~verify the ~~mice~~predicted ~~were~~clinical ~~infused~~benefit. In ~~with~~addition, afor ~~total~~products ofbeing ~~T-cells~~considered ~~containing~~for ~~EB103~~accelerated ~~or EB104~~approval, orthe ~~mock~~FDA Tgenerally ~~cells~~requires, ~~using~~unless ~~the~~otherwise ~~mock~~informed ~~T-cells~~by FDA, that asall ~~the~~advertising ~~control~~and ~~group.~~promotional ~~The~~materials ~~infusion~~intended offor ~~EB103~~dissemination ~~and~~or ~~EB104~~publication ~~showed~~within ~~tumor~~120 ~~control~~days ~~until~~of ~~day~~marketing ~~21,~~approval ~~while~~be ~~the~~submitted to ~~control~~FDA ~~group~~for ~~showed~~review ~~rapid~~during ~~tumor~~the ~~growth~~pre-approval period.

~~Furthermore~~In 2017, the FDA established ~~EB104~~a ~~showed~~new ~~potentially~~regenerative ~~better~~medicine ~~tumor~~advanced ~~control~~therapy, ~~compared~~or RMAT, designation, which is intended to ~~EB103.~~facilitate Atan ~~day~~efficient 21development program for, and ~~Nalm-6~~expedite ~~cells~~review ~~with~~of, 1%any ~~Nalm-6-CD19ko~~biologic that meets the following criteria: (~~expressing~~i) ~~CD22~~the biologic qualifies as a RMAT, ~~but~~which is defined as a cell ~~not~~therapy, ~~CD19)~~therapeutic ~~cells~~tissue ~~were~~engineering ~~injected~~product, ~~into~~human ~~mice~~cell ~~that~~and ~~were~~tissue ~~previously~~product, ~~treated~~or byany ~~EB103~~combination product using such therapies or ~~EB104~~products, with aslimited ~~re-challenge.~~exceptions; ~~This~~(ii) rethe biologic is intended to treat, modify, reverse, or cure a serious or life-~~challenge~~threatening ~~experiment~~disease or condition; ~~mimicked~~and ~~the~~(iii) ~~tumor~~preliminary ~~relapse~~clinical inevidence ~~patients~~indicates ~~due~~that the biologic has the potential to ~~CD19~~address ~~antigen~~unmet ~~escape~~medical needs for such a disease or condition. ~~Mice~~RMAT ~~treated~~designation ~~with~~provides ~~EB104~~all ~~showed~~the ~~“durable”~~benefits ~~tumor~~of ~~control~~breakthrough therapy designation, including more frequent meetings with the ~~meaning~~FDA ~~that~~to discuss the ~~tumor~~development ~~continued~~plan tofor ~~respond~~the toproduct ~~treatment~~candidate ~~without~~and eligibility for rolling review and priority review. Product candidates granted RMAT designation may also be eligible for accelerated approval on the ~~cancer~~basis ~~growing~~of a surrogate or ~~spreading~~intermediate endpoint reasonably likely to predict long-term clinical benefit, ~~and~~or ~~“clearance”~~reliance upon data obtained from a meaningful number of ~~tumors~~clinical trial sites, including ~~which~~through ~~refers~~expansion of trials to ~~the~~additional ~~complete~~sites. ~~killing~~RMAT-designated ofproducts ~~tumor~~that ~~cells~~receive accelerated approval may, ~~for~~as aappropriate, ~~total~~fulfill their post-approval requirements through submission of ~~more~~clinical ~~than~~evidence, 60clinical ~~days~~studies, patient registries, or 40other ~~days~~sources ~~after~~of real-world evidence (such as electronic health records); through the ~~re-challenge.~~collection ~~However,~~of ~~mice~~larger confirmatory data sets; or via post-approval monitoring of all patients treated with ~~EB103~~such ~~showed~~therapy ~~rapid~~prior ~~tumor~~to ~~growth~~approval ~~after~~of ~~the~~such ~~re-challenge~~therapy.

31Fast track designation, breakthrough therapy designation, priority review, accelerated approval, and RMAT designation do not change the standards for approval but may expedite the development or approval process. Even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

~~These pre-clinical~~Orphan ~~results~~Drug ~~showed~~Designation ~~that EB104 T-cells have the potential to eradicate Nalm-6 Primary Tumors~~ and ~~Nalm-6-CD19ko re-challenge tumors in the xenograft model, suggesting that EB104 T-cells have the potential to control the growth of tumor cells that do not express CD19.~~Exclusivity

~~Our~~Under the Orphan Drug ~~Collaboration~~Act, the FDA may grant orphan designation to a biologic intended to treat a rare disease or condition, defined as a disease or condition with ~~Imugene~~a patient population of fewer than 200,000 individuals in the United States, or a patient population greater than 200,000 individuals in the United States and ~~CF33-CD19t~~when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that biologic. Orphan drug designation must be requested before submitting a BLA. After the FDA grants orphan drug designation, the generic identity of therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.

~~CF33-CD19t and EB103~~17

AIn the United States, orphan ~~major~~drug ~~challenge~~designation entitles a party to financial incentives such as opportunities for ~~current~~grant Tfunding towards clinical trial costs, tax advantages and user-~~cell~~fee ~~therapies~~waivers. isIn ~~the~~addition, ~~identification~~if ofa ~~antigens~~product that ~~are~~has ~~expressed~~orphan ~~only~~drug ondesignation ~~tumors~~subsequently ~~and~~receives ~~not~~the infirst ~~healthy~~FDA ~~tissue.~~approval for a particular Indrug or biologic for the ~~absence~~disease offor ~~such~~which ~~restricted~~it ~~expression,~~has ~~CAR-T~~such ~~cell~~designation, ~~therapy~~the ~~poses~~product ~~considerable~~is ~~safety~~entitled ~~concerns~~to ~~and~~orphan ~~potentially~~product ~~narrows~~exclusivity, ~~therapeutic~~which means ~~window~~that ~~for~~the ~~their~~FDA ~~application~~may ~~against~~not ~~solid~~approve ~~tumors.~~any ~~CD19~~other ~~has~~applications, ~~been~~including ana ~~ideal~~full ~~target~~BLA, ~~for~~to ~~CAR-T~~market ~~cells~~the ~~against~~same ~~hematological~~biologic ~~malignancies~~for the same indication for seven ~~several~~years, ~~reasons~~except in limited circumstances, ~~including~~such ~~its~~as ~~highly~~a ~~restricted~~showing ~~expression~~of onclinical Bsuperiority ~~cells~~to ~~and~~the ~~acceptable~~product ~~off-tumor~~with ~~and~~orphan ~~on-target~~drug ~~properties.~~exclusivity Inor ~~addition to~~if the FDA ~~shared~~finds ~~expression~~that the holder of ~~solid~~the ~~tumor~~orphan ~~antigens~~drug onexclusivity ~~normal~~has ~~tissue,~~not ~~most~~shown ofthat ~~these~~it ~~antigens~~can ~~also~~assure ~~have~~the ~~heterogeneous~~availability ~~and~~of ~~nonuniform~~sufficient ~~expression~~quantities of ~~patterns~~the inorphan ~~tumors,~~drug ~~limiting~~to meet the ~~potential~~needs of patients with the disease or condition for ~~effective~~which ~~and~~the ~~durable~~drug ~~antitumor~~was ~~responses~~designated. ~~Many~~Orphan ~~solid~~drug ~~tumors,~~exclusivity does ~~including~~not ~~triple-negative breast~~prevent ~~cancers~~the ~~and~~FDA ~~liver~~from ~~cancers~~approving a different drug or biologic for the same disease or condition, ~~lack~~or ~~amenable~~the ~~tumor~~same ~~antigens~~drug or biologic for a ~~CAR-T~~different ~~cell~~disease ~~development~~or condition. ToCompetitors ~~potentially~~may ~~address~~receive approval of different products for the ~~issue~~indication offor which the ~~lack~~orphan product ofhas ~~solid~~exclusivity ~~tumor-specific~~or ~~targets,~~obtain weapproval ~~are~~for ~~collaborating~~the ~~with~~same ~~Imugene~~product ~~and~~but ~~its~~for a different indication for which the orphan product ~~candidate,~~has ~~CF33-CD19t,~~exclusivity. toOrphan product ~~research~~exclusivity also could block the ~~use~~approval of ~~EB103~~one of our products for seven years if a competitor obtains approval of the same inbiological ~~conjunction~~product ~~with~~as ~~CF33-CD19t~~defined by the FDA or if our product candidate is determined to ~~treat~~be ~~solid~~contained ~~tumors~~within ~~using~~the acompetitor’s ~~“mark~~product for ~~and~~the ~~kill”~~same ~~strategy~~indication or disease.

~~This~~A designated orphan drug may ~~“mark~~not ~~and~~receive ~~kill”~~orphan ~~strategy~~drug ~~entails~~exclusivity ~~first~~if ~~using~~it ~~CF33-CD19t~~is toapproved ~~infect~~for ~~solid~~a ~~tumor~~use ~~cells~~that is broader than the indication for which ~~induces~~it ~~them~~received toorphan ~~express~~designation. In addition, orphan drug exclusive marketing rights in the ~~CD19 protein~~United onStates may be lost if the ~~cell~~FDA ~~surface,~~later ~~thereby~~determines ~~labeling~~that the ~~tumor~~request ~~cell~~for designation was materially defective or, as noted above, if a ~~target~~second ~~for~~applicant ~~EB103~~demonstrates ~~T-Cells.~~that ~~The~~its ~~EB103~~product ~~T-cells~~is ~~are~~clinically ~~then~~superior ~~infused~~to the ~~into~~approved product with orphan exclusivity or the ~~patient~~ ~~where~~manufacturer ~~they~~of ~~would~~the ~~target~~approved ~~and~~product ~~kill~~is unable to assure sufficient quantities of the ~~now~~product ~~CD19-positive~~to ~~solid~~meet ~~tumor~~the ~~cells~~needs of patients with the rare disease or condition.

32Post-Approval Requirements

~~Collaboration~~Biologics are subject to pervasive ~~Agreement~~and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing, annual program fees for any marketed products. Biologic manufacturers and other entities involved in the manufacture and distribution of approved biological products are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP requirements and other laws, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Manufacturers and other parties involved in the drug supply chain for prescription drug products must also comply with product tracking and tracing requirements and for notifying the FDA of counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution in the United States. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain GMP compliance. Changes to the manufacturing process or facility are strictly regulated, and, depending on the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. 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.

OnThe FDA may withdraw approval ~~October~~if ~~29,~~compliance ~~2021,~~with ~~Eureka~~regulatory ~~entered~~requirements ~~into~~and astandards ~~collaboration~~is ~~agreement~~not (maintained or if problems occur after the ~~“Collaboration~~product ~~Agreement”)~~reaches the market. Later discovery of previously unknown problems with ~~Imugene~~a product, aincluding ~~clinical stage~~adverse ~~immuno-oncology~~events ~~company~~of unanticipated severity or frequency, or with manufacturing processes, or failure to ~~evaluate~~comply with regulatory requirements, may result in revisions to the ~~use~~approved labeling to add new safety information; imposition of ~~CF33~~post-~~CD19t~~market instudies ~~conjunction~~or ~~with~~clinical ~~Eureka’s~~studies ~~CD19~~to ~~ARTEMIS~~assess ~~T-cell~~new ~~therapy~~safety ~~for~~risks; ~~the treatment~~or imposition of ~~solid~~distribution ~~tumors~~restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

~~On July~~● ~~28,~~restrictions ~~2022,~~on ~~as part of~~ the ~~Separation,~~marketing ~~Eureka~~or ~~contributed~~manufacturing ~~and~~of ~~assigned~~ the ~~Collaboration Agreement to Estrella. Pursuant to the Collaboration Agreement~~product, ~~Estrella~~complete ~~and~~withdrawal ~~Imugene~~of ~~have each granted to~~ the ~~other~~product afrom ~~royalty free, non-exclusive, worldwide license, with~~ the ~~right~~market toor ~~grant and~~product authorize sublicenses, to their respective technologies to conduct the research activities each is responsible for performing under the research plan set forth in the Collaboration Agreement. The research plan is required to be reviewed no less frequently than every six to eight months by a joint steering committee comprised of participants from each of Estrella and Imugene.recalls;

~~Following the~~● ~~completion of the research activities performed under the research plan in accordance with the Collaboration Agreement~~fines, ~~Estrella and~~warning Imugene will be required to discuss whether they want to jointly develop or commercialize the construct that is the subject of the research plan (and all products that include such construct). Notwithstanding the foregoingletters, ~~neither Estrella nor Imugene will be required to enter into any joint development agreement concerning such construct~~ or ~~any~~untitled ~~results, records, or reports that are generated by or on behalf of either Estrella or Imugene while performing such research activities.~~letters;

Additionally, while Estrella and Imugene each retain their intellectual property rights with respect to their respective technologies and any improvements that relate solely to their respective technologies, in the event that new intellectual property is generated from the collaboration (each a “Joint Collaboration Patent Right”), Estrella and Imugene are required to jointly decide the strategy, and with respect to any Joint Collaboration Patent Rights, the preparation, filing, prosecution, and maintenance of all Joint Collaboration Patent Rights throughout the world. Estrella and Imugene are required to share equally in the costs and expenses incurred in preparing, filing, prosecuting, and maintaining such Joint Collaboration Patent Rights. If only one of Estrella or Imugene wishes to file a patent on any Joint Collaboration Patent Rights, then such party will assume all of the costs related to such patent, and the other party will assign all rights to such patent to the prosecuting party as if they were an improvement of that party’s technology, and the other party may only use such patent rights for internal research purposes.18

~~The Collaboration~~● ~~Agreement~~clinical ~~will~~holds ~~continue~~on toclinical be in full force and effect as long as there are research activities being performed under the research plan set forth therein, unless further extended by written consent of Estrella and Imugene, or unless earlier terminated as follows: (i) by written agreement of each of Estrella and Imugenestudies; (ii) from and after October 29, 2022 (or the termination of all research under the research plan set forth therein, whichever occurs first), by either Estrella or Imugene effective upon 60 days’ prior written notice to the other party; or (iii) by either Estrella or Imugene, if the other party materially breaches the Collaboration Agreement and fails to cure such breach within 60 days after receiving written notice thereof.

~~Potential Uses~~● ~~and~~refusal ~~Expansion/Market~~of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;

~~Solid tumors~~● ~~represent~~product ~~approximately~~seizure ~~1,600,000~~or ~~new cancer cases~~detention, or ~~90%~~refusal ofto ~~total~~permit ~~cancer diagnoses in~~ the ~~United~~import ~~States, each year. At this time, there are no FDA-approved CAR~~ or ~~TCR-T~~export ~~cell therapies approved for the treatment~~ of ~~solid tumors. Accordingly, it is currently difficult to estimate specific market projections and the potential for our “mark and kill” strategy.~~products;

~~Our Strategy~~● consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

~~Key elements~~● mandated modification of ~~our~~promotional ~~strategy~~materials ~~include:~~and labeling and the issuance of corrective information;

● ~~Progress~~the ~~our~~issuance ~~lead~~of ~~product~~safety ~~candidate~~alerts, ~~EB103,~~Dear ~~through~~Healthcare ~~clinical~~Provider ~~development. On March 2~~letters, ~~2023,~~press ~~the~~releases ~~FDA~~and ~~cleared~~other ~~our~~communications ~~IND~~containing ~~for~~warnings ~~EB103,~~or ~~allowing~~other ussafety toinformation ~~initiate~~about the ~~Phase~~product; ~~I/II Starlight-1 Clinical Trial, which dosed its first patient in July 2024.~~or

33● injunctions or the imposition of civil or criminal penalties.

●The ~~Prepare~~FDA ~~our~~also ~~second~~may ~~product~~require ~~candidate~~post-marketing testing, ~~EB104~~known as Phase 4 testing, ~~for~~and ~~clinical~~surveillance ~~development.~~to Wemonitor ~~are~~the ~~compiling~~effects of an ~~IND~~approved ~~filing~~product. ~~for~~Discovery ~~EB104~~of ~~for~~previously unknown problems with a product or the ~~treatment~~failure ofto ~~relapsed/refractory~~comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising or communications with doctors, and ~~high-risk~~civil ~~blood~~or ~~cancers~~criminal penalties, among others. ~~Phase~~Newly Idiscovered ~~trials~~or developed safety or effectiveness data may ~~not~~require ~~commence~~changes ~~until~~to a product’s approved labeling, including the ~~FDA~~addition ~~has~~of ~~approved~~new warnings and contraindications, and also may require the ~~IND~~implementation ~~for~~of ~~EB104~~other risk management measures.

●The ~~Progress~~FDA ~~researching~~closely regulates the ~~use~~marketing, labeling, advertising and promotion of ~~EB103~~biologics. A company can make only those claims relating to safety and efficacy, purity, and potency that are approved by the FDA and in ~~conjunction~~accordance with ~~CF33~~the provisions of the approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-~~CD19t~~label uses. The federal government has levied large civil and criminal fines against companies for ~~multiple~~alleged ~~indications~~improper promotion of ~~solid~~off-label ~~tumors~~use ~~through~~and ~~clinical~~has ~~development~~enjoined companies from engaging in off-label promotion. The FDA ~~cleared~~and ~~our~~other ~~IND~~regulatory ~~for~~agencies ~~EB103~~have onalso ~~March~~required 2that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. Failure to comply with these requirements can result in, ~~2023~~among other things, adverse publicity, warning letters, corrective advertising and ~~the~~potential ~~Starlight~~civil ~~Phase~~and ~~I/II~~criminal ~~clinical~~penalties. ~~trial~~FDA ~~for~~sanctions ~~EB103~~could ~~dosed~~include refusal ~~its~~to ~~first~~approve ~~patient~~pending inapplications, ~~July~~withdrawal ~~2024.~~of Ifan ~~the~~approval, ~~Phase~~clinical ~~I/II~~hold, ~~Starlight-1~~warning ~~Clinical~~or ~~Trial~~untitled isletters, ~~successful~~product recalls, weproduct seizures, ~~plan~~total toor ~~submit~~partial ansuspension ~~IND~~of ~~filing~~production ~~for~~or ~~the~~distribution, ~~use~~injunctions, fines, refusals of ~~EB103~~government incontracts, ~~conjunction~~mandated corrective advertising or communications with ~~CF33-CD19t~~doctors, indebarment, ~~the~~restitution, ~~future~~disgorgement of profits, or civil or criminal penalties. AtPhysicians may ~~this~~prescribe, ~~time~~in their independent professional and medical judgment, welegally ~~have~~available products for uses that are not ~~determined~~described in the product’s ~~specific~~labeling ~~indications~~and ofthat ~~solid~~differ ~~tumors~~from tothose betested ~~researched~~and orapproved anby ~~exact~~the ~~timeframe~~FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for ~~filing~~many ~~our~~patients ~~IND~~in ~~application~~varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.

●Biosimilars Continue to develop a pipeline of T-cell therapies. To address certain of the tolerability shortcomings of currently approved CAR-T therapies, we intend to continue pursue development of therapies that may be able to be adopted in earlier lines of treatment and toReference beProduct ~~delivered in community outpatient settings.~~Exclusivity

~~Our~~The Affordable Care Act, signed ~~Pipeline~~into oflaw ~~Clinical~~in ~~Programs~~2010, includes a subtitle called the Biologics Price Competition and Innovation Act, or BPCIA, which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars.

Our approach is to advance our CD19-Redirected ARTEMIS T Cell programs in relapsed/refractory and high-risk blood cancers first. Meanwhile, we are also developing multiple pipeline candidates against solid tumor and autoimmune disease. The following chart summarizes our clinical programs:19

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

~~Pursuant~~Under the BPCIA, an application for a biosimilar product may not be submitted to the ~~Services~~FDA ~~Agreement,~~until wefour ~~are~~years ~~supported~~following the date that the reference product was first licensed by ~~Eureka’s~~the ~~scientific~~FDA. ~~team~~In addition, ~~which~~the isapproval ~~comprised~~ of ~~leaders~~a inbiosimilar product may not be made effective by the ~~biopharmaceutical,~~FDA until 12 years from the date on which ~~oncology,~~the ~~and~~reference ~~T-cell~~product ~~cancer~~was ~~immunotherapy~~first ~~areas~~licensed. WeDuring ~~have~~this ~~leveraged~~12-year ~~their~~period ~~expertise~~of toexclusivity, ~~analyze~~another ~~preclinical~~company ~~data~~may ~~and~~still ~~design~~market ~~and~~a ~~implement~~competing version ~~our~~of ~~clinical~~the ~~trials.~~reference ~~Our~~product ~~CEO~~if ~~and~~the ~~President,~~FDA ~~Dr.~~approves ~~Cheng~~a ~~Liu,~~full BLA for the competing product containing that applicant’s own preclinical data and ~~members~~data offrom ~~our~~adequate ~~scientific~~and ~~advisory~~well-controlled ~~board~~clinical ~~are~~trials ~~pioneers~~to indemonstrate ~~their~~the ~~respective fields~~safety, ~~each~~purity, ~~having~~and ~~spent~~potency ~~their~~of ~~careers~~its ~~advancing~~product. ~~next-generation~~The ~~technologies~~BPCIA ~~and~~also created ~~providing~~certain ~~treatments~~exclusivity inperiods ~~these~~for ~~areas~~biosimilars approved as interchangeable products. InAt ~~addition~~this juncture, it is unclear whether products ~~our~~deemed ~~Chief~~“interchangeable” ~~Financial~~by ~~Officer~~the FDA will, ~~Peter~~in Xufact, ~~brings~~be ~~years~~readily ofsubstituted ~~executive~~by ~~experience~~pharmacies, ~~and~~which ~~investment~~are ~~management~~governed ~~abilities~~by state pharmacy law.

34A biological product can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of other exclusivity protection or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written Request” for such a study. The BPCIA is complex and continues to be interpreted and implemented by the FDA. In addition, government proposals have sought to reduce the 12-year reference product exclusivity period. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. As a result, the ultimate impact, implementation, and impact of the BPCIA is subject to significant uncertainty.

~~Our Board~~Government ~~includes~~Regulation ~~experienced~~Outside ~~industry~~of ~~leaders and investors who have been involved with many early-stage companies. Furthermore, we are supported by investors who share our belief that~~ the ~~world needs smarter medical treatments and our long-term vision that T-cell therapies~~United ~~have the potential to transform the way we fight cancer.~~States

~~Competition~~In addition to regulations in the United States, we will be subject to a variety of regulations in other jurisdictions governing, among other things, clinical studies and any commercial sales and distribution of our products. Because biologically sourced raw materials are subject to unique contamination risks, their use may be restricted in some countries.

~~The biotechnology~~Whether ~~and~~or ~~pharmaceutical~~not ~~industries~~we ~~are~~obtain ~~characterized~~FDA approval byfor ~~rapid~~a product, ~~unpredictable~~we ~~technological~~must ~~advancement~~obtain ~~and~~the ~~significant~~requisite ~~competition. These~~approvals ~~industries~~from ~~dedicate~~regulatory ~~significant~~authorities ~~resources~~in toforeign ~~developing~~countries ~~novel~~prior ~~and~~to ~~proprietary therapies for~~ the ~~treatment~~ commencement of ~~cancer,~~clinical ~~which~~studies ~~often incorporate~~or ~~innovative~~marketing ~~technologies~~of ~~and~~the ~~incorporate~~product ~~valuable~~in ~~intellectual~~those ~~property~~countries. WeCertain ~~compete~~countries ~~with~~outside ~~companies~~of in the ~~cell~~United ~~therapy~~States ~~and immunotherapy~~have ~~space,~~a assimilar ~~well~~process that asrequires ~~with~~the ~~companies~~submission ~~developing~~of ~~other~~a ~~novel~~clinical ~~targeted~~study ~~therapies~~application ~~for~~much ~~cancer.~~like Ifthe ~~approved,~~IND ~~our~~prior ~~product~~to ~~candidates will~~the ~~compete~~commencement ~~with~~of ~~commercially~~human ~~available~~clinical ~~and~~studies. ~~development-stage innovative products in~~ In the ~~fields~~European ofUnion, ~~cell~~for ~~and immunotherapy~~example, asa ~~well~~CTA ~~as against~~must ~~existing~~be ~~products~~submitted ~~generally~~to ~~accepted~~each ascountry’s ~~the~~national ~~standard-of-care~~health ~~for~~authority ~~indications~~and inan ~~which~~independent weethics ~~plan to seek marketing approval. We~~committee, ~~anticipate~~much ~~that~~like wethe ~~will~~FDA ~~face intense~~ and ~~increasing~~the ~~competition from many different sources~~IRB, ~~including~~respectively. ~~new~~Once ~~and~~the ~~established~~CTA ~~biotechnology and~~is ~~pharmaceutical~~approved ~~companies,~~in ~~academic~~accordance ~~research~~with ~~institutions,~~a ~~governmental~~country’s ~~agencies~~requirements, ~~and~~clinical ~~public~~study development ~~and~~may ~~private research institutions~~proceed.

~~Our product~~The ~~candidates~~requirements ~~cover~~and ~~both~~process governing ~~hematological~~the ~~malignancies~~conduct ~~and~~of ~~solid~~clinical ~~tumors~~studies, product licensing, pricing and wereimbursement ~~expect~~vary tofrom ~~face~~country ~~direct~~to ~~competition~~country. inIn ~~both~~all ~~areas~~cases, ~~from~~the ~~companies~~clinical ~~focused~~studies onare ~~CAR-T~~conducted ~~and~~in ~~other~~accordance ~~cell-based~~with ~~therapies.~~GCP ~~There~~and ~~are~~the ~~currently~~applicable ~~eight~~regulatory ~~total~~requirements ~~FDA-approved~~and ~~drugs~~the orethical ~~therapies~~principles ~~targeting~~that have ~~CD19,~~their ~~four~~origin ofin ~~which~~the ~~are~~Declaration ~~CD19-targeting~~of ~~T-cell therapies:~~Helsinki.

COMPANY	BRAND NAME	YEAR FIRST APPROVED	DISEASE(S)	LOCATIONS APPROVED
Novartis	Kymriah	2017	Acute lymphocytic leukemia; diffuse large B-cell lymphoma; follicular lymphoma	US, EU, UK, Japan, Australia, Canada, South Korea
Kite Pharma (Gilead)	Yescarta	2017	Diffuse large B-cell lymphoma; non-Hodgkin’s lymphoma; follicular lymphoma	US, EU, UK, Japan, Canada, China
Kite Pharma (Gilead)	Tecartus	2020	Mantel cell lymphoma; acute lymphocytic leukemia	US, EU, UK
Juno (Bristol Myers Squibb)	Breyanzi	2021	Diffuse large B-cell lymphoma; follicular lymphoma	US, Japan, EU, UK, Canada

~~Our~~To obtain regulatory ~~competitors~~approval ~~operating~~of an investigational biological product under European Union regulatory systems, we must submit a marketing authorization application. The application used to file the BLA in the TUnited States is similar to that required in the European Union, with the exception of, among other things, country-~~cell~~specific ~~therapy~~document ~~space~~requirements. ~~include~~The European Union also provides opportunities for market exclusivity. For example, in the European Union, upon receiving marketing authorization, new chemical entities generally receive eight years of data exclusivity and an additional two years of market exclusivity. If granted, data exclusivity prevents regulatory authorities in the European Union from referencing the innovator’s data to assess a generic application. During the additional two-year period of market exclusivity, a generic marketing authorization can be submitted, and the innovator’s data may be referenced, but ~~are~~no generic product can be marketed until the expiration of the market exclusivity. However, there is no guarantee that a product will be considered by the European Union’s regulatory authorities to be a new chemical entity, and products may not ~~limited~~qualify for data exclusivity. Products receiving orphan designation in the European Union can receive ten years of market exclusivity, during which time no similar medicinal product for the same indication may be placed on the market. An orphan product can also obtain an additional two years of market exclusivity in the European Union for pediatric studies. No extension to: any supplementary protection certificate can be granted on the basis of pediatric studies for orphan indications.

●The ~~Novartis~~criteria for designating an “orphan medicinal product” in the European Union are similar in principle to those in the United States. Under Article 3 of Regulation (~~Product:~~EC) ~~Kymriah~~141/2000, a medicinal product may be designated as orphan if (1) it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition; (2) either (a) such condition affects no more than five in 10,000 persons in the European Union when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the European Union to justify investment; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of such condition authorized for marketing in the European Union, or if such a method exists, the product will be of significant benefit to those affected by the condition, as defined in Regulation (EC) 847/2000. Orphan medicinal products are eligible for financial incentives such as reduction of fees or fee waivers and are, upon grant of a marketing authorization, entitled to ten years of market exclusivity for the approved therapeutic indication. The application for orphan drug designation must be submitted before the application for marketing authorization. The applicant will receive a fee reduction for the marketing authorization application if the orphan drug designation has been granted, but not if the designation is still pending at the time the marketing authorization is submitted. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

●The ~~Kite~~10-year ~~Pharma~~market exclusivity may be reduced to six years if, ~~Inc~~at the end of the fifth year, it 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. ~~(Products:~~Additionally, ~~Yescarta~~marketing authorization ~~and~~may ~~Tecartus)~~be granted to a similar product for the same indication at any time if:

● ~~Juno~~The ~~Therapeutics~~second ~~Inc.~~applicant ~~(Bristol~~can ~~Myers~~establish ~~Squibb)~~that ~~(Product:~~its ~~Breyanzi)~~product, although similar, is safer, more effective, or otherwise clinically superior;

● JWThe ~~Therapeutics~~applicant ~~(Product:~~consents ~~Carteyva/Relma-cel)~~to a second orphan medicinal product application; or

● ~~Adaptimmune~~The ~~Therapeutics~~applicant ~~PLC~~cannot ~~(Product~~supply ~~Candidate:~~enough ~~ADP-A2M4CD8~~orphan ~~SPEAR)~~medicinal product.

●For ~~TCR2~~other ~~Therapeutics~~countries ~~(Product~~outside of ~~Candidate:~~the ~~TC-520)~~European Union, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical studies, product licensing, pricing, and reimbursement vary from country to country. In all cases, again, the clinical studies are conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.

35If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

●Other ~~Poseida~~Healthcare ~~Therapeutics (Product Candidates: P-BCMA-ALLO1, P-MUC1C-ALLO1, and P-PSMA-ALLO1)~~Laws

●Pharmaceutical ~~Autolus~~companies ~~Therapeutics~~are subject ~~PLC~~to ~~(Product~~additional ~~Candidates:~~healthcare ~~obe~~regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they conduct their business and may constrain the financial arrangements and relationships through which we research, as well as, sell, market and distribute any products for which we obtain marketing approval. Such laws include, without limitation, federal and state anti-~~cel~~kickback, fraud and ~~Auto1/22)~~abuse, false claims, data privacy and security and physician and other health care provider transparency laws and regulations.

~~Our competitors pursuing CD19 targeted drugs outside of the T-cell therapy space include, but are not limited to:~~21

●In ~~Amgen~~order to distribute products commercially, ~~Inc~~we must also comply with state laws that require the registration of manufacturers and wholesale distributors of pharmaceutical products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state. ~~(Product:~~Some ~~Blincyto)~~states also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution, including some states that require manufacturers and others to adopt new technology capable of tracking and tracing product as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, track and report gifts, compensation and other remuneration made to physicians and other healthcare providers, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical companies for use in sales and marketing, and to prohibit certain other sales and marketing practices. All of our activities are potentially subject to federal and state consumer protection and unfair competition laws.

●If ~~MorphoSys~~our AGoperations ~~(Product:~~are ~~Monjuvi)~~found to be in violation of any of the federal and state healthcare laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including without limitation, civil, criminal and/or administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions, private “qui tam” actions brought by individual whistleblowers in the name of the government, or refusal to allow us to enter into government contracts, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. For information regarding risks related to these compliance requirements, see the section titled “Risk Factors — Risks Related to Government Regulations.”

●Coverage ~~Horizon~~and ~~Therapeutics plc (Product: Uplizna)~~Reimbursement

●Sales ~~ADC~~of ~~Therapeutics~~any SAproduct ~~(Product:~~depend, in ~~Zynlonta)~~part, on the extent to which such product will be covered by third-party payors, such as federal, state, and foreign government healthcare programs, commercial insurance and managed healthcare organizations, and the level of reimbursement for such product by third-party payors. Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. These third-party payors are increasingly reducing coverage and reimbursement for medical products, drugs and services. Obtaining coverage and adequate reimbursement for our product candidates may be particularly difficult because of the higher prices often associated with drugs administered under the supervision of a physician. Similarly, because our product candidates are physician-administered, separate reimbursement for the product itself may or may not be available. Instead, the administering physician may or may not be reimbursed for providing the treatment or procedure in which our product is used.

~~Universities and~~In ~~research~~addition, ~~institutes have been a proven new technology source in~~ the ~~field as well~~U.S. ~~We also face competition from treatments in the~~government, ~~field~~state oflegislatures ~~immunotherapy which are being developed~~ and~~/or~~ ~~commercialized~~foreign bygovernments ~~several~~have ~~biotechnology~~continued ~~companies~~implementing ascost-containment ~~well~~programs, asincluding byprice ~~large~~controls, ~~pharmaceutical~~restrictions ~~companies.~~on ~~Such~~coverage ~~companies,~~and ~~whose~~reimbursement ~~immuno-oncology~~and ~~programs~~requirements ~~focus~~for onsubstitution ~~the~~of ~~same~~generic ~~indications~~products. orAdoption ~~antigen~~of ~~targets~~price ascontrols ~~our~~and ~~current~~cost-containment ~~pipeline. Other~~measures, ~~known~~and ~~types~~adoption of ~~immunotherapy,~~more ~~including~~restrictive ~~but~~policies ~~not~~in ~~limited~~jurisdictions towith ~~checkpoint~~existing ~~inhibition~~controls and ~~cancer vaccines~~measures, ~~are~~could ~~not~~further ~~currently~~limit ~~direct~~sales ~~competitors to~~of ~~T-cell-based~~any ~~therapeutics~~product. Decreases ~~However,~~in wethird-party ~~cannot~~reimbursement ~~predict~~for ~~whether~~any ~~these~~product ~~other~~or ~~types~~a ofdecision ~~immunotherapy~~by ~~may~~a ~~eventually~~third-party ~~show~~payor ~~efficacy~~not into ~~the indications~~cover ~~for~~a ~~which~~product wecould ~~may~~reduce ~~seek~~physician usage ~~marketing approval,~~ and itpatient isdemand ~~possible~~for ~~that~~the weproduct ~~may face direct~~ and ~~substantial~~also ~~competition~~have ~~from~~a ~~such sources~~material inadverse ~~the~~effect ~~future~~on sales.

~~Many of~~Healthcare our current or potential competitors, either alone or with a strategic partner, have significantly greater financial, technical, and human resources, as well as more expertise in research and development, manufacturing, preclinical testing, conducting clinical studies and trials and commercializing and marketing approved products. Competitors may compete with us in hiring scientific and management personnel, establishing clinical study sites, registering patients for clinical studies and acquiring technologies complementary to, or necessary for, our programs. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.Reform

~~Intellectual~~Payors, whether domestic or ~~Property~~foreign, or governmental or private, are developing increasingly sophisticated methods of controlling healthcare costs and those methods are not always specifically adapted for new technologies such as gene therapy and therapies addressing rare diseases such as those we are developing. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our products profitably.

~~Overview~~22

~~We own~~In ~~certain~~the ~~unregistered~~United ~~intellectual~~States, ~~property rights that we use~~ in March ~~connection with our business~~2010, ~~including~~the aPatient ~~common~~Protection ~~law~~and ~~trademark~~Affordable ~~for Estrella™.~~Care ~~We also own certain plasmids~~Act, ~~cell~~as ~~lines,~~amended ~~and~~by ~~materials~~the ~~related~~Health toCare ~~CD19~~ and ~~CD22~~Education inReconciliation ~~connection~~Act, ~~with~~each ~~the ARTEMIS®~~as ~~platform~~amended, ~~and~~collectively ~~trade~~known ~~secrets~~as ~~and~~the ~~other~~ACA, ~~intellectual~~was ~~property~~enacted, ~~rights~~which ~~related~~substantially ~~thereto.~~changed ~~A material portion of~~ the ~~intellectual~~way ~~property we~~healthcare ~~use~~is infinanced ~~our~~by ~~business~~both isgovernmental and ~~in-licensed~~private ~~from Eureka~~insurers, asand ~~described~~significantly ~~below.~~affected Wethe ~~are~~pharmaceutical ~~also~~industry. ~~party~~The toACA ~~the~~contained ~~Collaboration~~a ~~Agreement~~number ~~with~~of ~~Imugene~~provisions, including asthose ~~described~~governing ~~above,~~enrollment toin ~~conduct~~federal ~~certain~~healthcare ~~preclinical~~programs, ~~research~~reimbursement ~~projects~~adjustments toand ~~investigate~~changes ~~the~~to ~~use~~fraud ofand ~~EB103~~abuse inlaws. ~~conjunction with CF33-CD19t for~~For ~~efficacy~~example, inthe ~~solid tumors.~~ACA:

~~License Agreement~~● ~~with~~increased ~~Eureka~~the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1% of the average manufacturer price;

~~On June~~● ~~28,~~required ~~2022,~~collection we entered into the License Agreement with Eureka and Eureka Therapeutics (Cayman), Inc. to license certain functions related to any T-cell products that incorporate (a) the ARTEMIS® platform and (b)(i) the CD19 binder and/or (ii) the CD22 binder identified in the License Agreement (the “Licensed Product”). The License Agreement provides that, during the term, Eureka grants Estrella an exclusive license, with the right to grant sublicenses through multiple tiers to (a) make, import, use, sell or offer to sell the Licensed Products, (b) develop the Licensed Products solely for the purpose of ~~obtaining~~rebates ~~regulatory approval of such Licensed Products, (c) commercialize such Licensed products and (d) manufacture the Licensed Products solely~~ for ~~the~~drugs ~~purposes~~paid ~~of developing~~by ~~the~~Medicaid ~~Licensed~~managed ~~Products~~care ~~for purposed of obtaining regulatory approval of such Licensed Products and for commercializing such Licensed Products.~~organizations;

36● required manufacturers to participate in a coverage gap discount program, under which they must now agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; and

~~Pursuant to~~● ~~the~~imposed ~~terms~~a ofnon-deductible ~~the~~annual ~~License~~fee ~~Agreement,~~on inpharmaceutical ~~partial~~manufacturers ~~consideration~~or ofimporters ~~Eureka’s~~who ~~grant~~sell of“branded ~~the~~prescription ~~rights~~drugs” ~~and licenses~~ to ~~Estrella,~~specified ~~Estrella agreed~~federal togovernment ~~pay Eureka a one-time, non-refundable, non-creditable payment of $1,000,000~~programs. ~~As of October 2023, $1,000,000 has been paid to Eureka.~~

~~Eureka is~~On ~~eligible~~June to17, ~~receive~~2021, upthe toU.S. Supreme ~~five~~Court ~~one-time~~dismissed ~~development~~the ~~milestone~~most ~~payments~~recent ~~from~~judicial ~~Estrella~~challenge into the ~~aggregate~~ACA ~~amount~~brought ofby ~~$60,150,000~~several ifstates ~~all five~~without ~~development~~specifically ~~milestones~~ruling ~~are~~on ~~achieved~~the constitutionality of the ACA. ~~Effective~~Prior asto ofthe ~~March~~Supreme 1,Court’s ~~2023~~decision, ~~the~~President ~~parties~~Biden ~~further~~issued ~~amended~~an ~~the~~Executive ~~License~~Order ~~Agreement~~ to ~~provide that~~initiate ifa ~~any~~special ~~development~~enrollment ~~milestone~~period from isFebruary ~~achieved~~15, ~~prior~~2021 tothrough ~~the~~August ~~Closing~~15, 2021 for purposes of ~~the~~obtaining ~~Business~~health ~~Combination,~~insurance coverage through the ~~corresponding~~ACA ~~development~~marketplace. ~~milestone~~The Executive ~~payment~~Order ~~will~~also ~~not~~instructed becertain ~~due~~governmental agencies to ~~Eureka~~review ~~until~~and ~~the~~reconsider ~~Closing~~their ofexisting ~~the~~policies ~~Business~~and ~~Combination.~~rules Onthat ~~January~~limit 30access to healthcare, including ~~2023~~among others, ~~one~~reexamining ~~development~~Medicaid ~~milestone~~demonstration ~~payment in~~projects ~~the~~and ~~amount~~waiver ofprograms ~~$50~~that include work requirements,~~000~~ ~~related~~and topolicies ~~the~~that create ~~submission~~unnecessary ofbarriers ~~EB103~~to obtaining access to health insurance coverage through Medicaid or the ~~FDA~~ACA. ~~was~~It ~~earned~~is byunclear ~~Eureka~~how ~~under~~other healthcare reform measures of the ~~Agreement,~~Biden ~~which~~administrations ~~became~~or ~~due~~other ~~and payable~~efforts, if any, to ~~Eureka~~challenge ~~upon~~repeal or replace the ~~Closing~~ACA, ofwill ~~the~~impact ~~Business~~our ~~Combination~~business.

~~Eureka~~Other legislative ischanges ~~also~~have ~~eligible~~been toproposed ~~receive~~and upadopted toin ~~four~~the ~~one-time~~United ~~sales~~States ~~milestone~~since ~~payments~~the ~~from~~Affordable ~~Estrella~~Care ~~based~~Act was enacted. For example, on March 11, 2021, President Biden signed the ~~aggregate~~American ~~net~~Rescue ~~sales~~Plan Act of ~~all~~2021 ~~Licensed Products~~into bylaw, orwhich oneliminates ~~behalf~~the ofstatutory ~~Estrella~~Medicaid ordrug ~~any~~rebate cap, previously set at 100% of ~~its~~a ~~affiliates~~drug’s oraverage ~~sublicensees~~manufacturer inprice, ~~the~~for ~~Licensed~~single ~~Territory~~source ~~during~~and ~~any~~innovator ~~consecutive~~multiple ~~12-month~~source drugs, ~~period~~effective since January 1, 2024. Further, in August 2011, the ~~aggregate~~Budget ~~amount~~Control Act of ~~$225~~2011,~~000~~ among other things,~~000~~ ifcreated ~~all~~measures ~~four~~for spending ~~sales~~reductions ~~milestones~~by ~~are~~Congress. ~~achieved~~A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 ~~Each~~trillion ~~sales~~for ~~milestone~~the ~~payment~~years ~~will~~2013 ~~only~~through be2021, ~~paid~~was unable to reach required goals, thereby triggering the ~~once~~legislation’s automatic reduction to several government programs, ~~regardless~~including aggregate reductions of ~~the~~Medicare ~~number~~payments to providers of ~~Licensed~~2% ~~Products~~per orfiscal year. These reductions went into effect in April 2013 and, due to subsequent legislative amendments to the ~~number~~statute, ofwill ~~times~~remain ain ~~given~~effect ~~sales~~through ~~milestone~~2032 ~~has~~unless ~~been~~additional ~~achieved~~action is taken by Congress. ~~Estrella~~Pursuant isto ~~also~~the Coronavirus Aid, ~~responsible~~Relief, ~~(with~~and ~~input~~Economic ~~from~~Security ~~Eureka)~~Act, ~~for~~also known as the ~~preparation~~CARES Act, ~~filing~~as well as subsequent legislation, ~~prosecution~~these reductions were suspended from May 1, 2020 through March 31, 2022 due to the COVID-19 pandemic; they were limited to 1% from April 1, 2022 through June 30, 2022, and ~~maintenance~~fully ofreinstated at 2% thereafter. However, under the ~~patent~~Statutory ~~rights~~Pay-As-You-Go Act of 2010, ~~including~~additional ~~all~~sequestration reductions ~~associated~~of up to 4% have been triggered for 2026 in response to federal spending increases, resulting in a total effective ~~costs~~reduction of 4% for Medicare payments in that year, as Medicare cuts are capped at 4% under the law.

~~In addition~~Further, ~~during~~on ~~the~~May ~~applicable royalty term~~30, ~~Estrella will be required to pay to Eureka royalties in the amount of a single digit percentage~~2018, of the ~~aggregate~~Right ~~Net~~to ~~Sales~~Try ofAct ~~all~~was ~~Licensed~~signed ~~Products~~into ~~sold~~law. byThe orlaw, onamong ~~behalf~~other ofthings, ~~Estrella~~provides ~~or its affiliates or sublicensees in the Licensed Territory during~~ a ~~calendar~~federal ~~year.~~framework ~~Such~~for ~~amount is subject to~~ certain ~~reductions~~patients ~~(not~~ to ~~exceed~~access ~~50% of the amount otherwise payable) due~~certain toinvestigational ~~the~~new ~~expiration~~drug ofproducts ~~valid~~that ~~claims~~have ofcompleted a ~~licensed~~Phase ~~patent~~1 ~~right~~clinical intrial aand ~~given~~that ~~country~~are inundergoing ~~the~~investigation ~~Licensed~~for ~~Territory~~FDA ~~or due to 50% or greater declines~~approval. inUnder ~~sales~~certain ascircumstances, aeligible ~~result~~patients ofcan ~~generic~~seek ~~product~~treatment ~~competition~~without inenrolling ~~a given country~~ in ~~the~~clinical ~~Licensed~~trials ~~Territory.~~and ~~The~~without ~~royalty~~obtaining ~~term~~FDA ~~begins upon the first~~permission ~~commercial~~under ~~sale of a Licensed Product in a country in~~ the ~~Licensed~~FDA ~~Territory~~expanded ~~and~~access ~~continues~~program. ~~until~~There ~~the later of (a) the date on which such Licensed Product~~ is no ~~longer~~obligation ~~covered~~for by a ~~valid~~pharmaceutical ~~claim~~manufacturer ~~within~~to ~~Eureka’s~~make ~~licensed~~its ~~patent~~drug ~~rights~~products inavailable ~~such country, (b) the expiration~~to ofeligible ~~all~~patients ~~exclusive~~as ~~marketing rights or data protection or other exclusivity rights (other than patent rights) conferred by any regulatory authority with respect to~~ a ~~product~~result ~~in a country or jurisdiction that prohibits the commercialization~~ of ~~a generic product, including orphan drug exclusivity or pediatric exclusivity for such licensed product in such country, and (c) 12 years after~~ the ~~first~~Right ~~commercial sale~~to ofTry ~~such licensed product in such country~~Act.

The License Agreement will remain in effect on a licensed product-by-licensed product and country-by-country basis, until the expiration of the royalty term for a licensed product in a country and will finally expire upon expiration of the royalty term for the final Licensed Product. Estrella may terminate the License Agreement for any reason or no reason upon 120 days’ prior written notice to Eureka. Either party has the right to terminate the License Agreement upon material breach of the other party that is not cured within 90 days after the breaching party receives written notice of such breach from the non-breaching party.23

AsMoreover, there has been ofheightened ~~June~~governmental 30scrutiny over the manner in which manufacturers set prices for their marketed products, ~~2024~~which has resulted in several Congressional inquiries, weproposed ~~have~~and ~~fully~~enacted ~~paid~~legislation, and executive orders designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. Key developments include the Inflation Reduction Act of 2022, which authorizes the Secretary of Health and Human Services to negotiate maximum fair prices for certain high-cost drugs covered under Medicare Part D starting in 2026 and Part B starting in 2028. The first set of negotiated prices for 10 Part D drugs took effect on January 1, 2026, resulting in discounts ranging from 38% to 79% off 2023 list prices and estimated annual savings of $6 billion for Medicare and $1.5 billion in out-of-pocket costs for beneficiaries. Additional cycles of negotiation are ongoing,~~000~~ with prices for 15 more Part D drugs effective in 2027 and the inclusion of Part B drugs in 2028. Further,~~000~~ ~~license~~in ~~fee~~February 2026, Congress passed bipartisan legislation reforming pharmacy benefit managers (PBMs), banning spread pricing in Medicaid and requiring 100% rebate pass-throughs to ~~Eureka~~employers, with PBM compensation shifting to flat fees starting in 2028. Under the current Trump administration, executive actions have advanced most-favored-nation (MFN) pricing, with agreements announced in December 2025 for nine pharmaceutical companies to align U.S. prices with those in other developed nations for certain products, extending to Medicaid programs. In January 2026, the Department of Health and Human Services issued guidance allowing manufacturers to offer lower-cost drugs directly to patients, including Medicare and Medicaid enrollees, under safeguards to comply with anti-kickback statutes. Individual states in the United States have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

~~On January~~Data ~~30,~~Privacy 2023, one development milestone payment in the amount of $50,000 related to the submission of EB103 to the FDA was earned by Eureka under the Agreement, which was paid on October 10, 2023. No other development milestone, sales milestone, or royalty payment has been earned as of June 30, 2024, as we do not have any product candidates approved for sale and ~~have~~Security not generated any revenue from product sales. With the dosing of the first patient in July 2024 in the STARLIGHT-1 clinical trial, the development milestone pursuant to Section 8.2.1 (First Patient Dosed in the First Clinical Trial of a Licensed Product) in the Licensing Agreement with Eureka was met. As a result, Estrella made a payment of $50,000 to Eureka for reaching this milestone. As of September 2024, two patients have been dosed in the STARLIGHT-1 clinical trial.Laws

37We also are or will become subject to privacy laws in the jurisdictions in which we are established or in which we sell or market our products or run clinical trials. For example, in Europe we are subject to the GDPR in relation to our collection, control, processing and other use of personal data (i.e., data relating to an identifiable living individual). We process personal data in relation to participants in our clinical trials in the EEA, including health and medical information of these participants. The GDPR also provides that individual EEA countries may introduce further conditions of their own, including limitations which could limit our ability to collect, use and share personal data.

~~Eureka~~The GDPR imposes onerous ~~Patent~~accountability ~~Information~~obligations requiring data controllers and processors to maintain a record of their data processing and implement policies as part of its mandated privacy governance framework. It also requires data controllers to be transparent and disclose to data subjects (in a concise, intelligible and easily accessible form) how their personal information is to be used; imposes limitations on retention of personal data; defines pseudonymized (i.e., key-coded) data; introduces mandatory data breach notification requirements; and sets higher standards for data controllers to demonstrate that they have obtained valid consent for certain data processing activities. Fines for certain breaches of the GDPR are significant: up to the greater of €20 million or 4% of total global annual turnover. A breach of the GDPR or other applicable privacy and data protection laws and regulations could also result in regulatory investigations, reputational damage, orders to cease/change our use of data, enforcement notices, or potential civil claims including class action type litigation. Further, we comply with the GDPR and separately the UK GDPR, which, together with the amended UK Data Protection Act 2018, retains the GDPR in UK national law. The GDPR and the UK GDPR each have the ability to fine up to the greater of €20 million/£17 million or 4% of global turnover. The European Commission renewed the UK adequacy decisions under the GDPR and the Law Enforcement Directive in December 2025, extending them until December 2031, enabling continued free flow of personal data from EEA member states to the UK. These decisions are subject to a mid-term review after four years and may be renewed further based on ongoing assessments. These frameworks may lead to additional compliance costs and could increase our overall risk.

In addition, the GDPR places restrictions on cross-border data transfers. Certain aspects of cross-border data transfers under the GDPR remain subject to ongoing regulatory guidance and enforcement. The GDPR will increase our responsibility and liability in relation to personal data ~~table~~that ~~below~~we ~~sets~~process ~~forth~~where ~~patents~~such ~~owned~~processing is subject to the GDPR, and we may be required to put in place additional mechanisms to ensure compliance with the GDPR, including as implemented by ~~Eureka~~individual ~~relating~~countries. We are also subject to ~~EB103~~European Union rules with respect to cross-border transfers of personal data out of the EEA. Recent legal developments in the European Union have created complexity and ~~EB104~~uncertainty regarding transfers of personal data from the EEA to other countries whose data protection standards have not been deemed “adequate” by the European Commission (including the United States). ~~The~~On ~~expiration~~July ~~date~~10, 2023, the European Commission adopted an adequacy decision for ~~each~~the ~~patent~~EU-US isData ~~October~~Privacy 21Framework, ~~2036~~which remains in effect as of February 2026 and enables transfers of personal data from the EEA to US entities certified under the framework. As supervisory authorities issue further guidance on personal data export mechanisms, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results.

TITLE

JURISD.

STATUS

DATE FILED

LOCAL FILING DATE

APPLICATION NO.

PUBLICATION DATE AND NO.

GRANT DATE AND PATENT NO.

TYPE OF PATENT PROT.

PROD. CANDIDATES COVERED

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

2/25/22

2022201334

3/31/22 AU2022201334

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Issued

10/21/2016

3/26/18

2016342041

4/19/18 2016342041

3/17/22 2016342041

Composition of Matter; Use

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

4/20/18

3,001,137

4/27/173001137A1

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

12/16/20

20214936.5

6/30/21 EP3842450

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

5/18/18

16858388.8

8/29/183365364

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

3/27/18

258405

5/31/18258405

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

4/3/18

201817012671

7/20/18 201817012671 A

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

12/17/21

2021 – 204862

3/30/22 2022 – 050431

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

4/20/18

2018 – 520406

1/17/19 JP2019 – 500848A

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

5/17/18

10 – 2018 – 7014004

6/11/18 10 – 2018 – 0063325

Composition of Matter; Use; Process

EB103; EB104

38Further, the exit of the United Kingdom, or UK, from the European Union, often referred to as Brexit, has created uncertainty with regard to data protection regulation in the UK. Specifically, the UK exited the European Union on January 1, 2020, subject to a transition period that ended December 31, 2020. Under the post-Brexit Trade and Cooperation Agreement between the European Union and the UK, the UK and European Union agreed that transfers of personal data to the UK from EEA member states will not be treated as ‘restricted transfers’ to a non-EEA country. The European Commission renewed the UK adequacy decisions in December 2025, extending them until December 2031, subject to a mid-term review after four years. These decisions enable the free flow of personal data from EEA member states to the UK without additional transfer mechanisms.

TITLE

JURISD.

STATUS

DATE FILED

LOCAL FILING DATE

APPLICATION NO.

PUBLICATION DATE AND NO.

GRANT DATE AND PATENT NO.

TYPE OF PATENT PROT.

PROD. CANDIDATES COVERED

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

4/17/18

MX/a/2018/004721

7/6/18 2018004721

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

10/12/21

781463

10/29/21 NZ781463

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

10/12/21

781465

10/29/21 NZ781465

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

3/26/18

741052

4/27/18741052

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Pending

10/21/2016

2/14/22

2022103665

3/5/22 RU2022103665

Composition of Matter; Use; Process

EB103; EB104

Antibody/T-cell Receptor Chimeric Constructs and Uses Thereof

Issued

10/21/2016

9/4/18

16/121,475

1/24/19 US – 2019 – 0022216 A1

11/5/19 10464988

Use

EB103; EB104

In the United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws, including HIPAA, and federal and state consumer protection laws and regulations (e.g., Section 5 of the Federal Trade Commission Act) that govern the collection, use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations of our partners. In addition, certain state laws govern the privacy and security of personal information, including health-related information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts. For example, California enacted the CCPA, which creates individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling certain personal data of consumers or households. The CCPA requires covered companies to provide new disclosure to consumers about such companies’ data collection, use and sharing practices, provide such consumers new ways to opt-out of certain sales or transfers of personal information, and provide consumers with additional causes of action. The CCPA provides for civil penalties for violations, as well as a private right of action for certain data breaches that result in the loss of personal information. This private right of action may increase the likelihood of, and risks associated with, data breach litigation. The CCPA became effective on January 1, 2020, and (a) allows the California Attorney General to impose civil penalties for violations and (b) authorizes private lawsuits to recover statutory damages for certain data breaches. In addition, laws in all 50 U.S. states require businesses to provide notice to consumers whose personal information has been disclosed as a result of a data breach. State laws are changing rapidly and there is discussion in the U.S. Congress of a new comprehensive federal data privacy law to which we would become subject if it is enacted. The CCPA may impact our business activities and exemplifies the vulnerability of our business to the evolving regulatory environment related to personal data and protected health information. Additionally, a new privacy law, the California Privacy Rights Act, or CPRA, has been in effect since January 1, 2023. The CPRA significantly modifies the CCPA and imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data. It also expands the types of data breaches subject to the CCPA’s private right of action, provides for increased penalties for CPRA violations concerning California residents under the age of 16 and creates a new California data protection agency authorized to issue substantive regulations, which has resulted in increased privacy and information security enforcement. New regulations under the CCPA and CPRA took effect on January 1, 2026, including requirements for risk assessments, cybersecurity audits, and opt-out confirmation mechanisms. Ensuring compliance with the CPRA could require us to incur additional costs and expenses.

39In order to distribute products commercially, we must comply with state laws that require the registration of manufacturers and wholesale distributors of pharmaceutical products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state. Some states also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution, including some states that require manufacturers and others to adopt new technology capable of tracking and tracing product as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, track and report gifts, compensation and other remuneration made to physicians and other healthcare providers, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical companies for use in sales and marketing, and to prohibit certain other sales and marketing practices. All of our activities are potentially subject to federal and state consumer protection and unfair competition laws.

~~Government Regulation~~25

~~The U.S.~~If ~~Food~~our ~~and~~operations ~~Drug~~are ~~Administration,~~found to orbe ~~FDA,~~in ~~and~~violation ~~other~~of ~~regulatory~~any ~~authorities~~of atthe federal, and state healthcare and ~~local~~privacy ~~levels,~~laws asdescribed ~~well~~above asor inany ~~foreign~~other governmental regulations that ~~countries,~~apply ~~extensively~~to ~~regulate~~us, ~~among~~we ~~other~~may ~~things,~~be ~~the~~subject ~~research,~~to ~~development~~penalties, ~~testing~~including without limitation, ~~manufacture~~civil, ~~quality~~criminal ~~control~~and/or administrative penalties, ~~import~~damages, ~~export~~fines, ~~safety~~disgorgement, ~~effectiveness~~imprisonment, ~~labeling,~~exclusion ~~packaging,~~from ~~storage,~~participation ~~distribution,~~in ~~record~~government ~~keeping~~programs, ~~approval,~~such ~~advertising,~~as ~~promotion~~Medicare and Medicaid, ~~marketing~~injunctions, ~~sampling~~private “qui ~~post-approval~~tam” ~~monitoring~~actions ~~and~~brought ~~post-approval~~by ~~reporting~~individual ofwhistleblowers ~~biologics~~in ~~such~~the asname ~~those~~of wethe ~~are~~government, ~~developing.~~or ~~Any~~refusal ~~product~~to ~~candidates~~allow ~~that~~us weto ~~develop must~~enter beinto ~~approved~~government contracts, bycontractual ~~the~~damages, ~~FDA~~reputational ~~before~~harm, ~~they~~administrative ~~may~~burdens, bediminished ~~legally~~profits ~~marketed~~and infuture ~~the~~earnings, ~~United States~~ and by the ~~appropriate foreign regulatory agency~~curtailment ~~before~~or ~~they~~restructuring ~~may~~of beour ~~legally~~operations, ~~marketed~~any inof ~~those~~which ~~foreign~~could ~~countries.~~adversely ~~Generally,~~affect our ~~activities~~ability into ~~other~~operate ~~countries~~our ~~will~~business beand ~~subject~~our toresults ~~regulation~~of operations. ~~that~~For isinformation ~~similar~~regarding inrisks ~~nature~~related ~~and~~to ~~scope~~these ascompliance ~~that~~requirements, ~~imposed~~see in the ~~United~~section ~~States,~~titled ~~although~~“Risk ~~there~~Factors ~~can~~— beRisks ~~important~~Related to ~~differences~~Government Regulation.”

~~U.S. Regulation~~Material Agreements

~~Biologic Development~~Services ~~Process~~Agreement

In Pursuant to the ~~United~~Services ~~States~~Agreement, we ~~biological~~agreed ~~products~~to ~~are~~(i) ~~subject~~pay toEureka ~~regulation~~$10.0 ~~under~~million in connection with the ~~Federal~~services ~~Food,~~thereunder ~~Drug,~~payable ~~and~~in ~~Cosmetic~~12 ~~Act,~~equal ~~the~~monthly ~~Public~~installments ~~Health~~and ~~Service~~(ii) ~~Act,~~reimburse ~~and~~Eureka ~~other~~on ~~federal,~~a ~~state,~~monthly ~~local~~basis ~~and~~for ~~foreign~~reasonable ~~statutes~~pass-through ~~and~~costs ~~their~~incurred ~~implementing~~or ~~regulations.~~paid ~~The~~to ~~process~~providers ofby ~~obtaining~~Eureka ~~regulatory~~in ~~approvals and~~providing the ~~subsequent~~services. In ~~compliance~~addition, ~~with~~we ~~appropriate~~will ~~federal,~~be ~~state,~~charged ~~local~~for ~~and~~other ~~foreign~~services ~~statutes~~performed ~~and~~by ~~regulations~~Eureka ~~require~~outside the ~~expenditure~~scope of the services set forth in the Services Agreement, ~~substantial~~at a flat rate, by time ~~and~~or ~~financial~~materials ~~resources.~~or ~~The~~as ~~process~~mutually ~~required~~agreed byupon the ~~FDA~~parties ~~before~~in ~~biologics~~writing. ~~may~~As beof ~~marketed~~December in31, ~~the~~2025, ~~United~~we ~~States~~have ~~generally~~settled all amounts ~~involves~~owed ~~the~~under ~~following:~~this agreement.

●Statement ~~completion~~ of ~~preclinical~~Work ~~laboratory tests and animal studies performed in accordance with the FDA’s Good Laboratory Practice requirements, or GLP;~~#001

●Pursuant ~~submission~~to the Statement of Work #001 (“SOW”), effective March 4, 2024, as amended, we committed to paying Eureka $33.0 million for services related to the ~~FDA~~Phase I/II clinical trial of anEB103, ~~IND~~a T-cell therapy targeting CD19 using ARTEMIS® T-cell technology. As of December 31, 2025, Estrella has paid $3.5 million to Eureka for the fees associated with milestones achieved, and deposited $1.5 million for patient treatment expenses, which ~~must~~will ~~become~~be ~~effective~~applied ~~before~~to ~~clinical~~the ~~trials~~final ~~may~~invoice, ~~begin;~~with any unused portion refunded once all fees are settled. In addition, nine patient dosing and second site activation milestones have been completed as of December 31, 2025, and the Company has accrued approximately $12.4 million in accrued liability - related party and recorded $0.5 million in accounts payable – related party, for the corresponding dosing milestones.

●The ~~approval~~amended bySOW, anas ~~institutional~~entered on ~~review~~May ~~board~~13, or2024, ~~IRB~~clarifies that, in the event Estrella exercises its right to terminate or ~~ethics~~suspend ~~committee~~the atengagement ~~each~~with ~~clinical~~Eureka ~~site~~by ~~before~~providing written notice, Estrella will only be obligated to compensate Eureka for (i) services provided in connection with milestones achieved prior to the ~~trial~~termination isnotice, ~~commenced;~~(ii) reasonable and documented pass-through costs incurred prior to the termination notice, and (iii) amounts payable to third parties for commitments reasonably entered into prior to the termination notice, provided that Eureka makes commercially reasonable efforts to cancel or reduce such commitments.

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

●An ~~preparation~~overview of ~~and submission to~~ the ~~FDA of a Biologics~~ License Agreement ~~Application,~~with orEureka ~~BLA,~~is ~~after~~provided ~~completion~~above ofunder ~~all~~“Business ~~pivotal~~— ~~clinical~~Intellectual ~~trials;~~Property.”

~~● satisfactory completion of an FDA Advisory Committee review, if applicable;~~Facilities

●Our acorporate ~~determination~~headquarters are bylocated ~~the~~in ~~FDA~~Emeryville, ~~within~~California. 60We ~~days~~believe ofthat ~~its~~our ~~receipt~~existing offacilities aare ~~BLA~~adequate for our near-term needs but expect to ~~file~~need additional space as we grow. We believe that suitable additional or alternative space would be available as required in the ~~application~~future ~~for~~on commercially ~~review;~~reasonable terms.

● satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMP, and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity, and potency and, if applicable, to assess compliance with the FDA’s current Good Tissue Practice, or cGTP, requirements for the use of human cellular and tissue products, and of selected clinical investigation sites to assess compliance with GCPs;26

40Employees

●Most ~~potential~~of ~~FDA~~our ~~audit~~day-to-day ofoperations to ~~the~~date ~~nonclinical~~have been related to technology research and development, including the clinical ~~study~~development ~~sites~~of our lead product candidates. Many of the operational tasks that ~~generated~~we require are managed by Eureka pursuant to the ~~data~~Services inAgreement ~~support~~and SOW. As a result, we have a limited number of employees and do not expect to hire a significant number of new employees in the ~~BLA;~~near ~~and~~future.

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

~~Before testing~~Estrella ~~any~~Immunopharma, ~~biological~~Inc. files ~~product~~reports ~~candidate~~with inthe ~~humans,~~Securities ~~the~~and ~~product~~Exchange ~~candidate~~Commission ~~enters~~(SEC), ~~the~~including ~~preclinical~~annual ~~testing~~reports ~~stage.~~on ~~Preclinical~~Form ~~tests~~10-K, ~~also referred~~quarterly toreports ason ~~nonclinical~~Form ~~studies~~10-Q, and ~~include~~current ~~laboratory~~reports ~~evaluations~~on ofForm ~~product~~8-K. ~~chemistry,~~These ~~toxicity~~filings ~~and~~are ~~formulation,~~available ason ~~well~~the asSEC’s ~~animal studies~~website toat ~~assess~~www.sec.gov. ~~the~~Estrella’s ~~potential~~own ~~safety~~website ~~and~~www.estrellabio.com also ~~activity~~provides ofaccess ~~the~~to ~~product~~these ~~candidate.~~reports ~~The~~free ~~conduct~~ of ~~the~~charge ~~preclinical~~as ~~tests~~soon ~~must~~as ~~comply~~reasonably ~~with~~practicable ~~federal regulations~~after ~~and~~filing ~~requirements~~with ~~including~~the ~~GLPs~~SEC.

~~Prior to~~Item ~~beginning the first clinical trial with a product candidate in the United States, we must submit an IND to the FDA~~1A. AnRisk ~~IND is a request for authorization from the FDA to administer an investigational new drug to humans~~Factors. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical studies. Some preclinical testing may continue even after the IND is submitted. The IND also includes 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. 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.

~~In addition~~You toshould ~~the~~consider ~~submission~~carefully ofthe anrisks ~~IND~~and touncertainties ~~the~~described below, ~~FDA~~together ~~before~~with ~~initiation~~all of ~~a clinical trial in~~ the ~~United~~other ~~States,~~information ~~certain~~contained ~~human~~in ~~clinical~~this ~~trials involving~~Annual ~~recombinant~~Report. orIf ~~synthetic~~any ~~nucleic acid molecules are subject to oversight~~ of ~~institutional~~the ~~biosafety~~following ~~committees~~events occur, orour ~~IBCs~~business, as ~~set~~financial ~~forth~~condition inand ~~the~~operating ~~National~~results ~~Institutes~~may ofbe ~~Health,~~materially oradversely ~~NIH,~~affected. ~~Guidelines~~In ~~for~~that ~~Research Involving Recombinant DNA Molecules~~event, or the ~~NIH~~trading ~~Guidelines. Specifically,~~price ~~under the NIH Guidelines, supervision~~ of ~~human~~our ~~gene~~securities ~~transfer trials includes evaluation and assessment by an IBC~~could decline, ~~a local institutional committee that reviews~~ and ~~oversees~~you ~~research~~could ~~utilizing~~lose ~~recombinant~~all or ~~synthetic~~part ~~nucleic~~of ~~acid~~your ~~molecules at that institution~~investment. The ~~IBC~~risks ~~assesses the safety of the research~~ and ~~identifies~~uncertainties ~~any~~described ~~potential~~below ~~risk~~are tonot ~~public health or~~ the ~~environment,~~only ~~and~~ones ~~such~~we ~~review may~~face. ~~result~~Additional inrisks ~~some~~and ~~delay~~uncertainties ~~before~~that ~~initiation~~we ofare aunaware ~~clinical~~of, ~~trial.~~or ~~While~~that ~~the~~we ~~NIH~~currently ~~Guidelines~~believe are not ~~mandatory~~material, ~~unless~~may ~~the~~also ~~research~~become inimportant ~~question~~factors isthat ~~being~~adversely ~~conducted~~affect atour business or ~~sponsored~~results byof ~~institutions~~operations. ~~receiving~~For ~~NIH~~a ~~funding~~summary of ~~recombinant~~these orRisk ~~synthetic nucleic acid molecule research~~Factors, ~~many~~ ~~companies~~see ~~and~~“Summary ~~other~~Risk ~~institutions not otherwise subject to the NIH Guidelines voluntarily follow them~~Factors.”

~~Clinical trials~~Risks ~~involve~~Related ~~the administration of the investigational product~~ to ~~human~~Estrella’s ~~subjects under the supervision of qualified investigators in~~Operating ~~accordance~~History with GCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical study. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and ~~the~~Financial effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for any subsequent protocol amendments. Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins at that site, and must monitor the study until completed. An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the informed consent form that must be provided to each clinical trial subject or his or her legal representative and must monitor the clinical trial 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 study 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 studies and clinical study results to public registries.Condition

41We are a clinical stage biotechnology company with a history of losses. We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability.

~~For~~We are a clinical-stage biotechnology company with a history of losses. ~~purposes~~Since our inception, we have devoted substantially all of ~~BLA~~our ~~approval~~resources to organizing and staffing our company, ~~human~~business ~~clinical~~planning, ~~trials~~raising capital, ~~are~~and ~~typically~~conducting ~~conducted~~discovery, research and development activities for our product candidates, and we have incurred significant operating losses. Our net losses were approximately $13.1 million and $8.8 million for the year ended December 31, 2025, and the unaudited twelve months ended December 31, 2024, respectively. As of December 31, 2025, and December 31, 2024, we had an accumulated deficit of approximately $37.0 million and $23.9 million, respectively. Substantially all of our losses have resulted from expenses incurred in ~~three~~connection ~~sequential~~with regulatory ~~phases~~filings, ~~that~~research ~~may~~and ~~overlap~~development, and from general and administrative costs associated with our operations. To date, we have not generated any revenue from product sales, and we have not sought or beobtained ~~combined:~~regulatory approval for any product candidate. Furthermore, we do not expect to generate any revenue from product sales for the foreseeable future, and we expect to continue to incur significant operating losses for the foreseeable future due to the cost of research and development, preclinical studies, clinical trials, and the regulatory approval process for our current and potential future product candidates.

●We ~~Phase~~expect 1our —net ~~The~~losses ~~investigational product is initially introduced into healthy human subjects or patients with the target disease or condition. These studies are designed~~ to increase ~~test~~substantially the safety, dosage tolerance, absorption, metabolism, and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. In the case of some products for severe or life-threatening diseases, such as ~~cancer, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients.~~we:

● ~~Phase~~continue 2our —ongoing The investigational product is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages, dose tolerance, and dosing schedule and to identify possible adverse side effects and safety risks. Multiple Phase 2 clinical ~~trials~~trial ~~may~~of ~~be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials.~~EB103;

● ~~Phase~~continue 3 — The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the ~~overall~~development ~~risk/benefit ratio~~ of ~~the~~our ~~investigational~~preclinical ~~product and to provide an adequate basis for product approval. Generally, two adequate and well-controlled Phase 3 clinical trials are required by the FDA for approval of a BLA.~~programs;

~~In some~~● ~~cases,~~acquire ~~the~~and ~~FDA~~license ~~may require~~technologies, orif ~~companies~~any ~~may~~are ~~voluntarily pursue~~discovered, ~~additional~~that ~~clinical~~are ~~trials~~aligned ~~after~~with aour product is approved to gain more information about the product in the intended therapeutic indication, particularly for long-term safety follow-up. Completion of these so-called Phase 4 studies may also be made a condition to approval of the BLA.candidates;

~~Concurrent with~~● ~~clinical~~seek ~~trials,~~regulatory ~~companies~~approval ~~may complete additional animal studies and develop additional information about the biological characteristics~~ of the product candidate, and must finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, must develop methods for testing the safety, purity, and potency of the final product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.EB103;

~~BLA Submission~~● ~~and~~incur ~~Review~~expenses byrelated to the ~~FDA~~discovery and development of any potential future product candidates;

~~Assuming successful~~● ~~completion~~expand ofour ~~all required testing in accordance with all applicable regulatory requirements~~operational, ~~the results of product development~~financial, ~~nonclinical~~ ~~studies~~ and ~~clinical~~management ~~trials~~systems ~~are submitted to the FDA as part of a BLA requesting approval to market the product for one or more indications. The BLA must include all relevant data available from preclinical~~ and ~~clinical~~increase ~~studies~~personnel, including ~~negative~~personnel ~~or ambiguous results as well as positive findings, together with detailed information relating~~ to ~~the~~support ~~product’s~~our ~~chemistry,~~preclinical ~~manufacturing, controls,~~ and ~~proposed labeling, among other things. Data can come from company-sponsored~~ clinical ~~studies~~development ~~intended to test the safety~~ and ~~effectiveness of~~commercialization a use of the product, or from a number of alternative sources, including studies initiated by independent investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and effectiveness of the investigational drug product to the satisfaction of the FDA. The submission of a BLA requires payment of a substantial application user fee to the FDA, unless a waiver or exemption applies.efforts;

Within 60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before the FDA accepts it for filing. The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information. In this event, the BLA must be resubmitted with the additional information. The resubmitted application also is subject to review before the FDA accepts it for filing.27

42● continue to develop, perfect, and defend our intellectual property portfolio; and

~~Once a~~● ~~BLA~~incur ~~has~~additional ~~been accepted for filing~~legal, ~~the FDA’s goal is to review standard applications within ten months after the filing date~~accounting, ~~or,~~ if the application qualifies for priority review, six months after the FDA accepts the application for filing. In both standard and priority reviews, the review process may also be extended by FDA requests for additional information or ~~clarification. The FDA reviews a BLA to determine, among~~ other ~~things,~~expenses ~~whether a product is safe, pure, and potent and the facility~~ in ~~which~~operating itour ~~is manufactured~~business, ~~processed, packed,~~including ~~or held meets standards designed to assure~~ the ~~product’s~~additional ~~continued~~costs ~~safety,~~associated ~~purity~~with ~~and~~operating ~~potency.~~as ~~The FDA may also convene an advisory committee to provide clinical insight on application review questions. An advisory committee is~~ a ~~panel~~public of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditionscompany. ~~The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.~~

~~Before approving a BLA~~However, the ~~FDA~~amount ~~will~~of ~~typically~~our future ~~inspect~~losses ~~the facility or facilities where the product~~ is ~~manufactured~~uncertain. ~~The~~Our ~~FDA~~ability ~~will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP and adequate~~ to ~~assure consistent~~achieve ~~production~~or ofsustain ~~the~~profitability, ~~product~~if ~~within required specifications. For a product candidate that is also a human cellular or tissue product~~ever, ~~the FDA also~~ will ~~not~~depend ~~approve~~on, ~~the~~among ~~application~~other ifthings, ~~the manufacturer is not in compliance with cGTPs. These are FDA regulations~~successfully ~~that~~developing ~~govern~~product ~~the~~candidates, ~~methods~~obtaining ~~used~~regulatory ~~in,~~approvals ~~and~~to ~~the~~market ~~facilities~~ and ~~controls~~commercialize ~~used~~product ~~for~~candidates, ~~the~~manufacturing ~~manufacture~~any ~~of human cells, tissues, and cellular and~~approved ~~tissue~~products ~~based~~on ~~products,~~commercially orreasonable ~~HCT/Ps~~terms, ~~which~~entering ~~are~~into ~~human~~potential ~~cells~~future ~~or tissue intended for implantation~~alliances, ~~transplant,~~establishing ~~infusion, or transfer into~~ a ~~human~~ ~~recipient.~~sales ~~The primary intent of the GTP requirements is to ensure that cell~~ and ~~tissue~~marketing ~~based~~organization ~~products~~or suitable ~~are~~third-party ~~manufactured~~alternatives infor aany ~~manner designed~~approved ~~to prevent the introduction~~product, ~~transmission~~ and ~~spread~~raising ofsufficient ~~communicable~~funds ~~disease. FDA regulations also require tissue establishments~~ to ~~register~~finance ~~and~~business ~~list~~activities. ~~their~~If ~~HCT/Ps with the FDA and~~we, ~~when~~or ~~applicable, to evaluate donors through screening and testing. Additionally,~~our ~~before~~potential ~~approving~~future ~~a BLA~~collaborators, ~~the~~are ~~FDA~~unable ~~will~~to ~~typically~~commercialize ~~inspect~~ one or more ~~clinical~~of ~~sites~~our toproduct ~~assure~~candidates, ~~compliance~~or ~~with~~if ~~GCP.~~sales Ifrevenue ~~the~~from ~~FDA~~any ~~determines~~product candidate that ~~the~~receives ~~application,~~approval ~~manufacturing~~is ~~process or manufacturing facilities are not acceptable~~insufficient, itwe will ~~outline~~not ~~the~~achieve ~~deficiencies in the submission and often will request additional testing~~ or ~~information.~~sustain ~~Notwithstanding~~profitability, ~~the~~which ~~submission~~could ofhave ~~any~~a ~~requested~~material ~~additional~~adverse ~~information, the~~effect ~~FDA~~on ~~ultimately~~our ~~may~~business, ~~decide~~financial ~~that~~condition, ~~the~~results ~~application~~of ~~does~~operations, ~~not~~and ~~satisfy the regulatory criteria for approval~~prospects.

~~After the~~We ~~FDA~~will ~~evaluates~~need asubstantial ~~BLA~~additional ~~and conducts inspections of manufacturing facilities where the investigational product and/or its drug substance~~funds ~~will~~to beadvance ~~produced,~~development ~~the FDA may issue an approval letter or a Complete Response Letter, or CRL. An approval letter authorizes commercial marketing~~ of ~~the~~ product ~~with specific prescribing information for specific indications. A CRL indicates that the review cycle of the application is complete~~candidates, and ~~the~~we ~~application~~cannot ~~will~~guarantee ~~not~~that bewe ~~approved in its present form. A CRL~~ will ~~describe~~have ~~all~~sufficient offunds ~~the~~available ~~deficiencies that the FDA has identified~~ in the ~~BLA,~~future ~~except that where the FDA determines that the data supporting the application are inadequate~~ to ~~support~~develop ~~approval, the FDA may issue the CRL without first conducting required inspections, testing submitted product lots,~~ and~~/or~~ ~~reviewing~~commercialize ~~proposed labeling.~~our Incurrent ~~issuing the CRL, the FDA may recommend actions that the applicant might take to place the BLA in condition for approval, including requests for additional information~~ or ~~clarification.~~potential ~~The~~future FDA may delay or refuse approval of a BLA if applicable regulatory criteria are not satisfied, require additional testing or information and/or require post-marketing testing and surveillance to monitor safety or efficacy of a product. Ifcandidates ~~a CRL is issued, the sponsor must resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw the application. Even if such data~~ and ~~information are submitted, the FDA may decide that the BLA does not satisfy the criteria for approval~~technologies.

~~If regulatory~~The ~~approval~~development of ~~a product is granted, such approval will be granted for particular indications and may entail limitations on the~~biotechnology ~~indicated uses for which such~~ product ~~may~~candidates beis ~~marketed~~capital-intensive. ~~For~~If ~~example,~~any ~~the FDA may approve the BLA with a Risk Evaluation and Mitigation Strategy, or REMS, to ensure the benefits~~ of ~~the~~our ~~product~~current ~~outweigh its risks,~~ or ~~otherwise limit the scope of any approval. A REMS is a safety strategy implemented to manage a known or~~ potential ~~serious~~future ~~risk~~product ~~associated~~candidates ~~with~~enter ~~a product~~ and toadvance ~~enable~~through ~~patients to have continued~~preclinical ~~access~~studies toand ~~such~~clinical ~~medicines~~trials, bywe ~~managing~~will ~~their~~need ~~safe~~substantial ~~use,~~additional ~~and~~funds ~~could~~to ~~include~~expand ~~medication~~our ~~guides~~development, ~~physician communication plans or elements to assure safe use~~regulatory, ~~such as restricted distribution methods~~manufacturing, ~~patient registries~~ marketing, and ~~other~~sales ~~risk minimization tools~~capabilities. ~~The~~We ~~FDA~~will ~~also~~require ~~may~~significant ~~condition approval~~funds ~~on,~~to ~~among~~continue ~~other things, changes~~ to ~~proposed~~develop ~~labeling~~our ~~or the development of adequate controls and specifications. Once approved, the FDA may withdraw the~~ product ~~approval~~candidates ~~if compliance with pre-~~ and ~~post-marketing~~conduct ~~requirements~~further isresearch ~~not maintained or if problems occur~~and ~~after~~development, ~~the~~including ~~product~~preclinical ~~reaches the marketplace. The FDA may require one or more Phase 4 post-market~~ studies and ~~surveillance~~clinical totrials. ~~further~~In ~~assess and monitor the product’s safety and effectiveness after commercialization~~addition, ~~and~~we ~~may~~expect ~~limit~~to ~~further~~incur ~~marketing~~significant ofadditional ~~the~~costs ~~product based~~associated onwith ~~the~~operating ~~results~~as ofa ~~these~~public ~~post-marketing studies~~company.

43As of December 31, 2025, and December 31, 2024, we had approximately $1.4 million and $0.9 million, respectively, in cash and cash equivalents. Our future capital requirements and the period for which our existing resources will support our operations may vary significantly from what we expect. Because the length of time and activities associated with successful research and development of platform technologies and product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities. The timing and amount of our operating expenditures will depend largely on:

~~Expedited Development~~● the timing and ~~Review~~progress ~~Programs~~of preclinical and clinical development of our current and potential future product candidates;

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

~~A product~~● ~~candidate~~the ~~intended~~terms toof ~~treat~~any ~~a serious or life~~third-~~threatening~~party ~~disease~~manufacturing orcontract condition may also be eligible for breakthrough therapy designation to expedite its development and review. A product candidate can receive breakthrough therapy designation if preliminary clinical evidence indicates that the product candidate, alone or inbiomanufacturing ~~combination~~partnership ~~with~~we ~~one or more other drugs or biologics,~~ may ~~demonstrate~~enter substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. The designation includes all of the fast track program features, as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to expedite the development and review of the product candidate, including involvement of senior managers.into;

~~Any marketing~~● ~~application~~our ~~for~~ability ~~a biologic submitted~~ to ~~the~~maintain ~~FDA~~our ~~for~~current ~~approval~~licenses, ~~including~~conduct aour ~~product~~research ~~candidate with a fast track designation~~ and~~/or breakthrough~~ ~~therapy~~development ~~designation, may be eligible for other types of FDA~~ programs ~~intended to expedite development~~ and ~~review,~~establish ~~such~~new ~~as priority~~strategic ~~review~~partnerships and accelerated approval. A product candidate is eligible for priority review if it has the potential to provide safe and effective therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment, diagnosis or prevention of a disease compared to marketed products. The FDA will attempt to direct additional resources to the evaluation of an application for a new biological product designated for priority review in an effort to facilitate the review. For original BLAs, priority review designation means the FDA’s goal is to take action on the marketing application within six months of the 60-day filing date (as compared to ten months under standard review).collaborations;

~~Additionally, product~~● ~~candidates studied for their safety and effectiveness in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination that~~ the ~~product~~progress has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the ~~condition~~development ~~and~~efforts ~~the availability or lack~~ of ~~alternative~~our ~~treatments.~~existing Asstrategic apartners ~~condition of accelerated approval, the FDA will generally require the sponsor to perform adequate~~ and ~~well-controlled~~third ~~post-marketing~~parties ~~clinical~~with ~~studies~~whom towe ~~verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. Products receiving accelerated approval~~ may bein ~~subject to expedited withdrawal procedures if~~ the ~~sponsor~~future ~~fails~~enter tointo ~~conduct~~collaboration ~~the~~and ~~required~~research post-marketing studies or if such studies fail to verify the predicted clinical benefit. In addition, for products being considered for accelerated approval, the FDA generally requires, unless otherwise informed by FDA, that all advertising and ~~promotional~~development ~~materials intended for dissemination or publication within 120 days of marketing approval be submitted to FDA for review during the pre-approval period.~~agreements;

44● the costs involved in obtaining, maintaining, enforcing, and defending patents and other intellectual property rights;

~~In 2017,~~● the ~~FDA~~cost ~~established a new regenerative medicine advanced therapy, or RMAT, designation, which is intended to facilitate an efficient development program for,~~ and ~~expedite~~timing ~~review~~ of, ~~any~~regulatory biologic that meets the following criteria: (i) the biologic qualifies as a RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, with limited exceptionsapprovals; ~~(ii) the biologic is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition;~~ and (iii) preliminary clinical evidence indicates that the biologic has the potential to address unmet medical needs for such a disease or condition. RMAT designation provides all the benefits of breakthrough therapy designation, including more frequent meetings with the FDA to discuss the development plan for the product candidate and eligibility for rolling review and priority review. Product candidates granted RMAT designation may also be eligible for accelerated approval on the basis of a surrogate or intermediate endpoint reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of clinical trial sites, including through expansion of trials to additional sites. RMAT-designated products that receive accelerated approval may, as appropriate, fulfill their post-approval requirements through submission of clinical evidence, clinical studies, patient registries, or other sources of real-world evidence (such as electronic health records); through the collection of larger confirmatory data sets; or via post-approval monitoring of all patients treated with such therapy prior to approval of such therapy.

~~Fast track~~● ~~designation,~~our ~~breakthrough~~efforts ~~therapy~~to ~~designation,~~enhance ~~priority~~operational ~~review,~~systems ~~accelerated approval,~~ and ~~RMAT~~hire ~~designation~~additional dopersonnel, ~~not~~including ~~change~~personnel ~~the~~to ~~standards for~~support ~~approval but may expedite the~~ development ~~or approval process. Even if a product candidate qualifies for one or more~~ of ~~these~~our ~~programs, the FDA may later decide that the~~ product nocandidates ~~longer~~and ~~meets~~satisfy ~~the~~our ~~conditions~~obligations ~~for~~as ~~qualification~~a orpublic ~~decide that the time period for FDA review or approval will not be shortened~~company.

~~Orphan Drug Designation and Exclusivity~~28

~~Under~~To date, we have ~~the~~primarily ~~Orphan~~financed ~~Drug~~our ~~Act,~~operations through the ~~FDA~~sale ~~may~~of ~~grant~~equity ~~orphan~~securities. ~~designation~~We may seek to araise ~~biologic~~any ~~intended~~necessary toadditional ~~treat~~capital through a ~~rare~~combination ~~disease~~of public or ~~condition~~private equity offerings, ~~defined~~debt asfinancings, acollaborations, ~~disease~~strategic alliances, licensing arrangements, grants, and other marketing and distribution arrangements. We cannot assure you that we will be successful in acquiring additional funding at levels sufficient to fund our operations or ~~condition~~on ~~with~~terms afavorable ~~patient~~to ~~population~~us. ofIf ~~fewer~~we ~~than~~are ~~200~~unable to obtain adequate financing when needed,~~000~~ ~~individuals~~we inmay ~~the~~have ~~United~~to ~~States~~delay, reduce the scope of or asuspend ~~patient~~one ~~population~~or ~~greater~~more ~~than~~of ~~200~~our preclinical studies,~~000~~ ~~individuals~~clinical intrials, ~~the~~research ~~United~~and ~~States~~development ~~and~~programs ~~when~~or ~~there~~commercialization isefforts. noBecause ~~reasonable~~of ~~expectation~~the ~~that~~numerous risks and uncertainties associated with the ~~cost~~development and commercialization of ~~developing~~our current and ~~making~~potential ~~available~~future product candidates and the ~~drug or~~extent ~~biologic~~to inwhich we ~~the~~may ~~United~~enter ~~States~~into ~~will~~collaborations bewith ~~recovered~~third ~~from~~parties ~~sales~~to participate in their development and commercialization, we are unable to estimate the ~~United~~amounts ~~States~~of ~~for~~increased ~~that~~capital ~~biologic.~~outlays ~~Orphan~~and ~~drug~~operating ~~designation~~expenditures ~~must~~associated bewith our current and anticipated preclinical ~~requested~~studies ~~before~~and ~~submitting~~clinical atrials, ~~BLA~~including related manufacturing costs. ~~After~~To the ~~FDA~~extent ~~grants~~that ~~orphan~~we ~~drug~~raise ~~designation~~additional capital through collaborations, ~~the~~strategic ~~generic~~alliances, ~~identity~~or oflicensing ~~therapeutic~~arrangements ~~agent~~with ~~and~~third ~~its~~parties, ~~potential~~we may have to relinquish valuable rights to our ~~orphan~~current ~~use~~and ~~are~~potential ~~disclosed~~future ~~publicly~~product bycandidates, ~~the~~future ~~FDA.~~revenue ~~Orphan~~streams ~~drug~~or ~~designation~~research ~~does~~programs or grant licenses on terms that may not be ~~convey~~favorable ~~any~~to ~~advantage~~us. inIf we do raise additional capital through public or ~~shorten~~private equity or convertible debt offerings, the ~~duration~~ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other ~~regulatory~~preferences ~~review~~that ~~and~~adversely ~~approval~~affect ~~process~~our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends.

~~In the~~We ~~United~~do ~~States,~~not ~~orphan~~expect ~~drug designation entitles a party~~ to ~~financial incentives such as opportunities for grant funding towards clinical~~realize ~~trial~~revenue ~~costs,~~from ~~tax advantages and user-fee waivers. In addition, if a~~ product ~~that~~sales ~~has orphan drug designation subsequently receives the first FDA approval for a particular drug~~ or ~~biologic~~royalties ~~for~~from ~~the~~licensed ~~disease~~products for ~~which it has such designation,~~ the ~~product~~foreseeable ~~is entitled to orphan product exclusivity~~future, which means that the FDA may not approve any other applications, including a full BLA, to market the same biologic for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or if ~~the~~at FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic for the same disease or conditionall, orand ~~the same~~unless ~~drug~~and oruntil biologic for a different disease or condition. Competitors may receive approval of different products for the indication for which the orphan product has exclusivity or obtain approval for the same product but for a different indication for which the orphan product has exclusivity. Orphan product exclusivity also could block the approval of one of our ~~products for seven years if a competitor~~current ~~obtains~~and ~~approval~~potential offuture ~~the same biological~~ product ascandidates ~~defined~~are byclinically ~~the~~tested, ~~FDA~~approved ~~or if our product candidate is determined to be contained within the competitor’s product~~ for ~~the~~commercialization, ~~same~~and ~~indication~~successfully ~~or disease~~marketed.

~~A designated~~Members ~~orphan~~of ~~drug~~our ~~may~~management ~~not~~team ~~receive~~have ~~orphan drug exclusivity if it is approved for a use that is broader than the indication for which~~limited itexperience ~~received orphan designation. In addition, orphan drug exclusive marketing rights~~ in ~~the~~managing ~~United States may be lost if~~ the day-to-day ~~FDA~~operations ~~later determines~~of ~~that~~a ~~the~~public ~~request~~company ~~for designation was materially defective or~~and, as ~~noted~~a ~~above~~result, ifwe amay ~~second~~incur ~~applicant~~additional ~~demonstrates~~expenses ~~that its~~associated ~~product is clinically superior to the approved product~~ with ~~orphan exclusivity or~~ the ~~manufacturer~~management of ~~the~~our ~~approved product is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition~~company.

45Members of our management team have limited experience in managing the day-to-day operations of a public company. As a result, we may need to obtain outside assistance from legal, accounting, investor relations, or other professionals that could be more costly than planned. We may also hire additional personnel to comply with additional SEC reporting requirements. These compliance costs will make some activities significantly more time-consuming and costly. If we lack cash resources to cover these costs in the future, our failure to comply with reporting requirements and other provisions of securities laws could negatively affect our stock price and adversely affect our potential results of operations, cash flow and financial condition.

~~Post-Approval~~Our ~~Requirements~~consolidated financial statements expressing substantial doubt about our ability to continue as a going concern due to our history of recurring losses and our expectation that negative cash flows from operations will continue until we can generate sufficient revenue. Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations.

~~Biologics~~We ~~are~~have ~~subject~~incurred ~~to pervasive~~significant ~~and~~operating ~~continuing~~losses ~~regulation by the FDA, including, among other things, requirements relating~~ to ~~record-keeping~~date, ~~reporting of adverse experiences, periodic reporting, product sampling~~ and ~~distribution,~~it ~~and~~is ~~advertising~~possible ~~and~~we ~~promotion~~may ofnever ~~the~~generate ~~product.~~a ~~After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval~~profit. ~~There~~Our ~~also~~consolidated ~~are continuing,~~financial ~~annual~~statements ~~program~~included ~~fees for any marketed products. Biologic manufacturers and other entities involved~~ elsewhere in ~~the~~this ~~manufacture~~Annual ~~and~~Report ~~distribution of~~have ~~approved~~been ~~biological~~prepared ~~products~~on ~~are~~a ~~required~~going toconcern ~~register their establishments with the FDA and certain state agencies~~basis, ~~and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP requirements and other laws,~~ which ~~impose~~ ~~certain~~contemplates ~~procedural and documentation requirements upon us and our third-party manufacturers. Manufacturers and other parties involved in~~ the ~~drug~~realization ~~supply~~of ~~chain~~assets ~~for prescription drug products must also comply with product tracking~~ and ~~tracing~~satisfaction ~~requirements and for notifying the FDA~~ of ~~counterfeit, diverted, stolen and intentionally adulterated products or products that are otherwise unfit for distribution~~liabilities in the ~~United~~ordinary ~~States.~~course ~~Accordingly, manufacturers must continue to expend time, money, and effort in the area~~ of ~~production and quality control to maintain GMP compliance~~business. ~~Changes~~These toconsolidated ~~the~~financial ~~manufacturing~~statements ~~process~~do ornot ~~facility~~include ~~are~~any ~~strictly~~adjustments ~~regulated,~~relating ~~and,~~to ~~depending on~~ the ~~significance~~recoverability ~~of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation~~ and ~~correction~~classification of ~~any deviations~~recorded ~~from~~asset ~~cGMP~~amounts ~~and~~or ~~impose~~the ~~reporting~~amounts ~~requirements upon us~~ and ~~any~~classification ~~third-party~~of ~~manufacturers~~liabilities that wemight ~~may~~result ~~decide~~from ~~to use. Accordingly, manufacturers must continue to expend time, money and effort in~~ the ~~area~~outcome of ~~production~~these uncertainties ~~and~~related ~~quality control~~ to ~~maintain~~our ~~compliance~~ability ~~with cGMP~~to ~~and~~operate ~~other~~on ~~aspects~~a ofgoing ~~regulatory~~concern ~~compliance~~basis.

~~The~~In ~~FDA~~assessing ~~may~~our ~~withdraw~~liquidity ~~approval~~and the significant doubt about our ability to continue as a going concern, we monitor ifand ~~compliance~~analyze ~~with~~cash ~~regulatory~~on ~~requirements~~hand and ~~standards~~operating isexpenditure ~~not~~commitments. ~~maintained~~We orhave ifconcluded ~~problems~~that ~~occur~~our ~~after~~recurring ~~the~~losses ~~product~~from ~~reaches~~operations of approximately $13.1 million for the ~~market~~year ended December 31, 2025; accumulated deficit of approximately $37.0 million as of December 31, 2025; and net ~~Later~~operating ~~discovery~~cash outflow of ~~previously~~approximately ~~unknown~~$1.8 ~~problems~~million ~~with~~for athe ~~product~~year ended December 31, ~~including~~2025, ~~adverse~~and ~~events~~need offor ~~unanticipated~~additional ~~severity~~financing orto ~~frequency~~fund future operations raise substantial doubt about our ability to continue as a going concern. Similarly, orour ~~with~~independent registered public accounting ~~manufacturing~~firm ~~processes~~has included an explanatory paragraph in its report on our consolidated financial statements expressing substantial doubt about our ability to continue as a going concern. However, orour ~~failure~~management is of the opinion that we will not have sufficient funds to ~~comply~~meet ~~with~~our ~~regulatory~~working capital requirements, and debt obligations as they become due starting from one year from the date of this report due to the recurring loss. Changes may ~~result~~occur beyond our control that would cause us to consume our available capital before that time, including changes in and ~~revisions~~progress of our development activities and changes in regulation. Our future operations are highly dependent on a combination of factors, including but not necessarily limited to (1) the ~~approved~~success ~~labeling~~of toour ~~add~~research ~~new~~and development programs; (2) the timely and successful completion ~~safety~~of ~~information~~any additional financing; ~~imposition~~(3) the development of ~~post-market~~competitive ~~studies~~therapies orby ~~clinical~~other ~~studies~~biotechnology and pharmaceutical companies; (4) our ability to ~~assess~~manage ~~new~~growth ~~safety~~of ~~risks~~the organization; or(5) ~~imposition~~our ofability ~~distribution~~to ~~restrictions~~protect our technology and products; and, ultimately (6) regulatory approval orand ~~other~~successful ~~restrictions~~commercialization ~~under~~and amarket ~~REMS~~acceptance ~~program~~of our product candidates. ~~Other~~Our ~~potential~~future ~~consequences~~capital ~~include,~~requirements ~~among~~will ~~other~~depend ~~things~~on many factors, including:

● ~~restrictions on~~ the ~~marketing~~scope, orrate ~~manufacturing~~ of ~~the~~progress, ~~product~~results, ~~complete~~and ~~withdrawal~~costs of ~~the~~preclinical ~~product~~studies, ~~from~~laboratory ~~the~~testing, ~~market~~and orclinical trials for our product ~~recalls~~candidates;

~~● fines, warning letters, or untitled letters;~~29

● ~~clinical~~the ~~holds~~number onand ~~clinical~~development ~~studies~~requirements of product candidates that we may pursue, and other indications for our current product candidates that we may pursue;

● ~~refusal of~~ the ~~FDA~~costs, totiming ~~approve~~and ~~pending~~outcome ~~applications~~of orregulatory ~~supplements~~review ~~to approved applications, or suspension or revocation~~ of our product ~~license approvals~~candidates;

● ~~product seizure or detention, or refusal to permit~~ the ~~import~~scope orand ~~export~~costs of ~~products~~manufacturing arrangements;

● ~~consent~~the ~~decrees,~~cost ~~corporate~~associated ~~integrity~~with ~~agreements,~~commercializing ~~debarment~~any orapproved ~~exclusion~~product ~~from federal healthcare programs~~candidates;

● ~~mandated~~the ~~modification~~cost and timing of ~~promotional~~developing ~~materials~~our ~~and~~ability ~~labeling~~to ~~and~~establish ~~the~~sales ~~issuance~~and ofmarketing ~~corrective~~capabilities, ~~information~~if any;

● the ~~issuance~~costs of ~~safety alerts~~preparing, ~~Dear~~filing ~~Healthcare~~and ~~Provider~~prosecuting ~~letters~~patent applications, ~~press~~maintaining, ~~releases~~enforcing, and ~~other~~protecting ~~communications~~our ~~containing~~intellectual ~~warnings~~property orrights, ~~other~~defending ~~safety~~intellectual ~~information~~property-related ~~about~~claims, ~~the~~and ~~product;~~obtaining orlicenses to third-party intellectual property;

● ~~injunctions~~the ortiming ~~the~~and ~~imposition~~amount of ~~civil~~any milestone and royalty payments we are required to make under our present or ~~criminal~~future ~~penalties.~~license agreements;

~~The~~● ~~FDA~~our ~~also~~ability ~~may~~to ~~require~~establish ~~post-marketing testing,~~and ~~known~~maintain asstrategic ~~Phase~~partnerships ~~4 testing,~~ and surveillance to monitor the effects of an approved product. Discovery of previously unknown problems with a product or the failure to comply with applicable FDA requirements can have negative consequencescollaborations, including ~~adverse~~any ~~publicity, judicial~~biomanufacturing orpartnerships ~~administrative enforcement, warning letters from the FDA, mandated corrective advertising~~ or ~~communications~~collaborations ~~with~~involving ~~doctors, and civil or criminal penalties, among others. Newly discovered or developed safety or effectiveness data may require changes to a product’s approved labeling, including~~ the ~~addition~~use of ~~new~~our ~~warnings and contraindications~~products, ~~and~~on ~~also~~favorable ~~may~~terms, ~~require~~if ~~the~~at ~~implementation~~all; ~~of other risk management measures.~~and

46● the extent to which we acquire or in-license other product candidates and technologies and associated intellectual property.

~~The~~We ~~FDA~~will ~~closely~~require ~~regulates~~additional ~~the~~capital ~~marketing,~~to ~~labeling,~~complete ~~advertising~~our ~~and~~planned ~~promotion~~clinical ofdevelopment ~~biologics.~~programs Afor ~~company~~our ~~can~~current ~~make~~product ~~only~~candidates ~~those claims relating~~ to ~~safety~~obtain ~~and~~regulatory ~~efficacy, purity, and potency that are approved by the FDA and in accordance with the provisions of the approved label~~approvals. ~~The~~Any ~~FDA and other agencies~~additional ~~actively~~capital ~~enforce~~raising ~~the~~efforts ~~laws~~may ~~and~~divert ~~regulations~~our ~~prohibiting~~management ~~the~~from ~~promotion of off~~their day-~~label uses. The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off~~to-~~label~~day ~~use~~activities, ~~and has enjoined companies from engaging in off-label promotion. The FDA and other regulatory agencies have also required that companies enter into consent decrees or permanent injunctions under~~ which ~~specified~~may ~~promotional~~adversely ~~conduct~~affect isour ~~changed~~ability ~~or curtailed. Failure~~ to ~~comply with these requirements can result in, among other~~develop ~~things,~~and ~~adverse~~commercialize ~~publicity,~~our ~~warning~~current ~~letters, corrective advertising~~ and ~~potential~~future ~~civil and criminal penalties. FDA sanctions could include refusal to approve pending applications, withdrawal of an approval, clinical hold, warning or untitled letters,~~ product ~~recalls~~candidates, ~~product seizures,~~if total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, mandated corrective advertising or communications with doctors, debarment, restitution, disgorgement of profits, or civil or criminal penalties. Physicians may prescribe, in their independent professional and medical judgment, legally available products for uses that are not described in the product’s labeling and that differ from those tested and approved ~~by the FDA~~. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.

~~Biosimilars~~In addition, we cannot guarantee that future financing will be available on a timely basis, in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities by ~~Reference~~us, ~~Product~~whether ~~Exclusivity~~equity or debt, or the market perception that such issuances are likely to occur, could cause the market price of Common Stock to decline. If we are unable to raise sufficient capital when needed, our business, financial condition and results of operations will be harmed, and we will need to significantly modify our operational plans to continue as a going concern. If we are unable to continue as a going concern, we might have to liquidate our assets and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our consolidated financial statements.

~~The~~Risks ~~Affordable~~Related ~~Care~~to ~~Act, signed into law in 2010, includes a subtitle called~~ the ~~Biologics~~Development ~~Price Competition~~ and ~~Innovation Act, or BPCIA, which created an abbreviated~~Clinical ~~approval~~Testing ~~pathway~~of ~~for~~Our ~~biological~~Product products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars.Candidates

~~Biosimilarity,~~Our ~~which~~current ~~requires that there be no clinically meaningful differences between the biological~~ product ~~and~~candidates ~~the~~are ~~reference product~~ in ~~terms of safety, purity,~~either ~~and~~preclinical ~~potency,~~or ~~can be shown through analytical studies, animal studies, and a~~ clinical ~~study or studies~~development. ~~Interchangeability~~One ~~requires~~or ~~that a~~all ~~product~~of isour ~~biosimilar~~current ~~to the reference~~ product ~~and~~candidates ~~the~~may ~~product~~fail ~~must~~in ~~demonstrate that it can be expected to produce the same~~ clinical ~~results~~ asdevelopment ~~the~~or ~~reference~~suffer ~~product~~delays ~~in any given patient and, for products~~ that ~~are administered multiple times to an individual, the biologic~~ ~~and~~materially the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference biologic. However, complexities associated with the larger, and ~~often~~ ~~more~~adversely ~~complex,~~affect ~~structures~~their ofcommercial biological products, as well as the processes by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval pathway that are still being worked out by the FDAviability.

~~Under~~Our ~~the~~ability ~~BPCIA, an application for a biosimilar product may not be submitted~~ to ~~the~~achieve ~~FDA until four years following the date that the reference product was first licensed~~and bysustain ~~the~~profitability ~~FDA.~~depends ~~In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date~~ on ~~which the~~obtaining ~~reference~~regulatory ~~product~~approvals ~~was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA~~ for ~~the competing product containing that applicant’s own preclinical data~~ and ~~data~~successfully ~~from~~commercializing ~~adequate and well-controlled clinical trials to demonstrate the safety, purity, and potency of its~~ product. ~~The BPCIA also created certain exclusivity periods for biosimilars approved as interchangeable products. At this juncture~~candidates, iteither iswith ~~unclear whether products~~Eureka ~~deemed~~pursuant ~~“interchangeable”~~to by the ~~FDA~~Services ~~will,~~Agreement inor ~~fact,~~with beother ~~readily substituted by pharmacies, which are governed by state pharmacy law~~collaborators.

ABefore ~~biological product can also~~obtaining ~~obtain~~regulatory ~~pediatric~~approval ~~market~~for ~~exclusivity in~~ the ~~United~~commercial ~~States.~~distribution ~~Pediatric~~of ~~exclusivity,~~our ifproduct ~~granted~~candidates, ~~adds~~we ~~six~~or ~~months~~a tocollaborator ~~existing~~must ~~exclusivity~~conduct ~~periods~~extensive ~~and~~preclinical ~~patent~~studies ~~terms.~~and ~~This~~clinical ~~six-month~~trials ~~exclusivity,~~to ~~which~~demonstrate ~~runs~~the ~~from~~safety, ~~the~~purity, ~~end~~and efficacy of ~~other~~our ~~exclusivity~~product ~~protection~~candidates orin ~~patent~~humans. ~~term,~~We cannot ~~may~~ be ~~granted~~certain ~~based on~~of the ~~voluntary~~timely completion ofor aoutcome ~~pediatric~~of ~~study~~our inpreclinical ~~accordance~~studies ~~with~~and ancannot ~~FDA-issued~~predict ~~“Written~~if ~~Request”~~the ~~for~~FDA ~~such~~or aother ~~study. The~~regulatory ~~BPCIA~~authorities iswill ~~complex~~accept ~~and~~our ~~continues~~proposed toclinical beprograms ~~interpreted~~or ~~and~~protocols. ~~implemented~~As bya ~~the~~result, ~~FDA.~~we Incannot ~~addition,~~be ~~government~~sure ~~proposals~~that ~~have~~we ~~sought~~will tobe ~~reduce~~able ~~the~~to submit ~~12-year~~additional ~~reference~~investigational ~~product~~new ~~exclusivity~~drug ~~period.~~applications ~~Other~~(“INDs”) ~~aspects~~or ofsimilar ~~the~~applications ~~BPCIA,~~for ~~some~~our ofproposed ~~which~~clinical ~~may~~programs ~~impact~~ on the ~~BPCIA~~timelines ~~exclusivity~~we ~~provisions~~expect, ~~have also~~if ~~been~~at ~~the~~all, ~~subject~~and ofwe ~~recent~~cannot ~~litigation.~~be Assure athat ~~result,~~submission ~~the~~of ~~ultimate~~such ~~impact,~~applications ~~implementation,~~will ~~and~~result ~~impact~~in of the ~~BPCIA~~FDA isor ~~subject~~other regulatory authorities allowing clinical trials to ~~significant uncertainty~~begin.

4730

~~Government~~Our ~~Regulation~~current product candidates ~~Outside~~are in either preclinical or clinical development, and we are subject to the risks of failure inherent in the ~~United~~development ~~States~~of product candidates based on novel approaches. We have completed the second dose cohort in the Phase I dose-escalation portion of our STARLIGHT-1 Phase I/II clinical trial of EB103, and an independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from the Phase I dose-escalation phase (n=9) and recommended advancing the trial into the Phase II expansion phase at the recommended Phase II dose. In the Phase I dose-escalation phase, no treatment-related serious adverse events were reported, and the high-dose cohort achieved a 100% complete response rate at Month 1 in all evaluable patients, many of whom were considered high-risk and ineligible for currently available commercial CD19 products. However, these results are based on a small number of patients and limited follow-up and may not be predictive of results in larger populations, additional cohorts, or later-stage trials, and there is no guarantee that we will be able to successfully complete the clinical development of EB103 or any of our other product candidates or that any product candidate will ultimately demonstrate a clinical benefit. Accordingly, you should consider our prospects in light of the costs, uncertainties, delays, and difficulties frequently encountered by clinical-stage biotechnology companies such as ours.

InWe ~~addition~~may tonot ~~regulations in the United States, we will~~ be ~~subject~~able to aaccess the ~~variety~~financial ofresources ~~regulations~~to incontinue ~~other~~the ~~jurisdictions~~development ~~governing,~~of ~~among~~our ~~other~~current ~~things,~~or ~~clinical~~potential ~~studies and~~future ~~any~~product ~~commercial~~candidates. ~~sales~~This ~~and~~may ~~distribution~~be ofexacerbated ~~our~~if we ~~products.~~experience ~~Because~~any ~~biologically~~issues ~~sourced~~that ~~raw~~delay ~~materials~~or ~~are~~prevent ~~subject~~regulatory toapproval ~~unique~~or ~~contamination risks~~commercialization, ~~their~~such ~~use may be restricted in some countries.~~as:

~~Whether~~● negative or ~~not~~inconclusive weresults ~~obtain FDA approval for a product, we must obtain the requisite approvals~~ from ~~regulatory~~our ~~authorities~~preclinical ~~in foreign countries prior to the commencement of clinical~~ studies or ~~marketing of the product in those countries. Certain countries outside of the United States have a similar process that requires the submission of a~~ clinical ~~study~~trials, ~~application~~leading ~~much like the IND prior~~ to ~~the commencement of human clinical studies. In the European Union, for example,~~ a ~~CTA~~decision ~~must~~or berequirement ~~submitted~~ to ~~each~~conduct ~~country’s~~additional ~~national~~studies ~~health~~or ~~authority~~abandon ~~and an independent ethics committee, much like the FDA and the IRB, respectively. Once the CTA is approved in accordance with a country’s requirements, clinical study development may proceed.~~programs;

~~The~~● ~~requirements and process governing the conduct of clinical studies,~~ product-related ~~licensing,~~side ~~pricing~~effects ~~and~~experienced ~~reimbursement~~by ~~vary~~participants ~~from~~in ~~country~~our ~~to country. In all cases, the~~ clinical ~~studies are conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.~~trials;

To● ~~obtain~~delays ~~regulatory approval of an investigational biological product under European Union regulatory systems, we must submit a marketing authorization application. The application used to file the BLA~~ in ~~the~~submitting ~~United~~INDs ~~States is similar to that required in the European Union, with the exception of, among other things, country-specific document requirements. The European Union also provides opportunities~~ for ~~market~~future ~~exclusivity. For example~~candidates, in ~~the~~or European Union, upon receiving marketing authorization, new chemical entities generally receive eight years of data exclusivity and an additional two years of market exclusivity. If granted, data exclusivity prevents regulatory authorities in the European Union from referencing the innovator’s data to assess a ~~generic~~suspension ~~application.~~or ~~During~~termination ~~the additional two-year period~~ of ~~market exclusivity,~~ a ~~generic~~clinical ~~marketing~~trial ~~authorization~~once can be submitted, and the innovator’s data may be referenced, but no generic product can be marketed until the expiration of the market exclusivity. However, there is no guarantee that a product will be considered by the European Union’s regulatory authorities to be a new chemical entity, and products may not qualify for data exclusivity. Products receiving orphan designation in the European Union can receive ten years of market exclusivity, during which time no similar medicinal product for the same indication may be placed on the market. An orphan product can also obtain an additional two years of market exclusivity in the European Union for pediatric studies. No extension to any supplementary protection certificate can be granted on the basis of pediatric studies for orphan indications.commenced;

~~The~~● ~~criteria~~conditions ~~for~~imposed designating an “orphan medicinal product” in the European Union are similar in principle to those in the United States. Under Article 3 of Regulation (EC) 141/2000, a medicinal product may be designated as orphan if (1) it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition; (2) either (a) such condition affects no more than five in 10,000 persons in the European Union when the application is made, or (b) the product, without the benefits derived from orphan status, would not generate sufficient return in the European Union to justify investment; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of such condition authorized for marketing in the European Union, or if such a method exists, the product will be of significant benefit to those affected by the ~~condition,~~FDA ~~as defined in Regulation (EC) 847/2000. Orphan medicinal products are eligible for financial incentives such as reduction of fees~~ or ~~fee~~other ~~waivers~~regulatory ~~and~~authorities ~~are,~~regarding ~~upon grant of a marketing authorization, entitled to ten years of market exclusivity for~~ the ~~approved~~scope therapeutic indication. The application for orphan drug designation must be submitted before the application for marketing authorization. The applicant will receive a fee reduction for the marketing authorization application if the orphan drug designation has been granted, but not if the designation is still pending at the time the marketing authorization is submitted. Orphan drug designation does not convey any advantage in, or ~~shorten~~design ~~the duration~~ of, ~~the~~our ~~regulatory~~clinical ~~review and approval process.~~trials;

48● delays in enrolling research subjects in clinical trials;

~~The~~● 10high drop-~~year~~out ~~market~~rates ~~exclusivity may be reduced to six years if, at the end~~ of ~~the~~research fifth year, it 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. Additionally, marketing authorization may be granted to a similar product for the same indication at any time if:subjects;

● ~~The~~inadequate ~~second~~supply ~~applicant~~or ~~can~~quality ~~establish~~of ~~that its~~ product, ~~although~~candidate ~~similar,~~materials isfor ~~safer,~~our ~~more~~clinical ~~effective, or otherwise clinically superior~~trials;

● ~~The~~chemistry, ~~applicant~~manufacturing, ~~consents~~and tocontrol a(“CMC”) ~~second~~challenges ~~orphan~~associated ~~medicinal~~with ~~product~~scaling ~~application;~~up ormanufacturing;

● ~~The~~greater-than-anticipated ~~applicant~~clinical ~~cannot~~trial ~~supply enough orphan medicinal product.~~costs;

~~For~~● ~~other~~poor ~~countries~~effectiveness ~~outside~~ of ~~the~~our ~~European Union, such as countries in Eastern Europe, Latin America or Asia, the requirements governing the conduct of clinical studies,~~ product ~~licensing,~~candidates ~~pricing,~~during ~~and reimbursement vary from country to country. In all cases, again, the~~ clinical ~~studies are conducted in accordance with GCP and the applicable regulatory requirements and the ethical principles that have their origin in the Declaration of Helsinki.~~trials;

If● weunfavorable ~~fail~~FDA toor ~~comply with applicable foreign regulatory requirements, we may be subject to, among~~ other ~~things, fines, suspension or withdrawal of~~ regulatory ~~approvals, product~~authority ~~recalls,~~inspection ~~seizure~~ of ~~products,~~a ~~operating~~clinical ~~restrictions~~trial ~~and~~or ~~criminal~~manufacturing ~~prosecution.~~site;

~~Other~~● ~~Healthcare Laws~~failure of Eureka or our third-party contractors to comply with regulatory requirements or meet their contractual obligations;

~~Pharmaceutical~~● ~~companies~~delays ~~are subject to additional healthcare regulation~~ and ~~enforcement~~changes ~~by the federal government and by authorities~~ in ~~the~~regulatory ~~states and foreign jurisdictions in which they conduct their business and may constrain the financial arrangements and relationships through which we research~~requirements, ~~as well as~~policies, ~~sell, market~~ and ~~distribute~~guidelines; any products for which we obtain marketing approval. Such laws include, without limitation, federal and state anti-kickback, fraud and abuse, false claims, data privacy and security and physician and other health care provider transparency laws and regulations.or

In● ~~order to distribute products commercially, we must also comply with state laws that require~~ the ~~registration~~FDA of manufacturers and wholesale distributors of pharmaceutical products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state. Some states also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution, including some states that require manufacturers and others to adopt new technology capable of tracking and tracing product as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, track and report gifts, compensation and other ~~remuneration~~regulatory ~~made~~authorities tointerpreting ~~physicians~~our and other healthcare providers, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data todifferently ~~pharmaceutical~~than ~~companies~~we ~~for use in sales and marketing, and to prohibit certain other sales and marketing practices~~do. ~~All of our activities are potentially subject to federal and state consumer protection and unfair competition laws.~~

~~If our operations are found to be in violation of any of the federal and state healthcare laws described above or any other governmental regulations that apply to us~~Further, we ~~may be subject to penalties~~, ~~including without limitation~~Eureka, ~~civil, criminal~~ and~~/or administrative penalties, damages, fines, disgorgement,~~ ~~imprisonment,~~any ~~exclusion~~existing ~~from~~or ~~participation~~potential infuture ~~government~~collaborator ~~programs,~~may ~~such~~never asreceive ~~Medicare~~approval ~~and Medicaid, injunctions, private “qui tam” actions brought by individual whistleblowers in the name of the government, or refusal~~ to ~~allow~~market usand tocommercialize ~~enter~~any ~~into~~product ~~government~~candidate. ~~contracts,~~Even if ~~contractual~~regulatory ~~damages,~~approval ~~reputational~~is ~~harm~~obtained, ~~administrative~~it ~~burdens,~~may ~~diminished~~be ~~profits~~for ~~and~~indications ~~future earnings, and the curtailment~~ or ~~restructuring of~~patient ~~our~~populations ~~operations,~~that ~~any~~are ofnot ~~which~~as ~~could~~broad ~~adversely~~as ~~affect~~we ~~our~~intended ~~ability~~or ~~to operate our business and our results of operations. For information~~may ~~regarding~~require ~~risks~~labeling ~~related~~that toincludes ~~these~~significant ~~compliance~~use ~~requirements,~~restrictions ~~see~~or ~~the~~safety ~~section titled “Risk Factors — Risks Related to Government Regulations~~warnings.”

4931

~~Coverage~~We may not be successful in our efforts to use and ~~Reimbursement~~expand our use of the ARTEMIS® platform to expand our pipeline of product candidates.

~~Sales~~A key element of ~~any~~our ~~product~~strategy is ~~depend~~to use and advance our use of the ARTEMIS® platform to design, in ~~part~~test, and build our portfolio of product candidates focused on the ~~extent~~treatment of cancer. Our and Eureka’s research and development efforts to ~~which~~date ~~such~~have resulted in our discovery and preclinical development of EB103 and other potential product ~~will~~candidates. beWe ~~covered~~received byIND ~~third-party~~clearance ~~payors,~~from ~~such~~the asFDA ~~federal~~for EB103 on March 2, ~~state~~2023, and have ~~foreign~~activated ~~government~~multiple ~~healthcare programs~~clinical sites, ~~commercial~~including ~~insurance~~UC ~~and~~Davis ~~managed~~Comprehensive ~~healthcare~~Cancer ~~organizations,~~Center and ~~the~~Baylor ~~level~~Scott & ofWhite ~~reimbursement~~Research Institute, for ~~such~~the ~~product~~ongoing ~~by third~~STARLIGHT-~~party~~1 ~~payors~~clinical trial (NCT06343311). An independent Data Safety Monitoring Board has completed its review of safety ~~Decisions~~data ~~regarding~~from the ~~extent~~Phase I dose escalation portion of ~~coverage~~STARLIGHT-1 (n=9) and, ~~amount~~based on the favorable safety profile observed, including the absence of ~~reimbursement~~treatment-related serious adverse events and a 100% complete response rate at Month 1 in the high-dose cohort, has recommended advancing the trial to bethe ~~provided~~Phase II ~~are~~expansion ~~made~~phase onat the recommended Phase II dose. The expansion phase is a ~~plan~~multi-bycenter, open-~~plan~~label ~~basis.~~study ~~These~~designed ~~third~~to further evaluate the safety and preliminary efficacy of EB103 in patients with relapsed or refractory B-~~party~~cell ~~payors~~non-Hodgkin’s lymphoma, and data from this expansion phase are ~~increasingly~~expected ~~reducing~~to ~~coverage~~inform ~~and~~our ~~reimbursement~~pivotal trial strategy for ~~medical~~EB103. ~~products~~However, we ~~drugs~~cannot ~~and~~assure ~~services.~~you ~~Obtaining~~that ~~coverage~~EB103 ~~and~~or ~~adequate reimbursement~~any ~~for~~of our other existing or future product candidates ~~may~~will successfully complete clinical trials or demonstrate these product candidates to be ~~particularly~~safe ~~difficult~~or ~~because~~effective oftherapeutics, ~~the~~and ~~higher~~we ~~prices~~may ~~often~~not ~~associated~~be ~~with~~able ~~drugs~~to ~~administered~~successfully develop any product ~~under~~candidates. ~~the~~Even ~~supervision~~if ofwe aare ~~physician.~~successful ~~Similarly,~~in ~~because~~expanding our pipeline of product candidates, ~~are~~any ~~physician-administered,~~additional ~~separate~~product ~~reimbursement~~candidates that we identify may not be suitable for clinical development or generate acceptable clinical data, including as a result of being shown to have unacceptable effects or other characteristics that indicate that they are unlikely to be products that will receive marketing approval from the ~~product~~FDA or ~~itself~~other ~~may~~regulatory authorities or ~~may~~achieve market acceptance. If we do not successfully develop and commercialize product candidates, we will not be ~~available~~able to generate product revenue in the future. ~~Instead~~Moreover, our ability to complete the ~~administering~~clinical ~~physician~~trial ~~may~~for EB103 or ~~may~~commence and ~~not~~complete bea ~~reimbursed~~clinical trial for ~~providing~~any ~~the~~other ~~treatment~~product candidate may depend on our ability to obtain sufficient funding from various sources. orIf ~~procedure~~we infail ~~which~~to obtain adequate funding we may have to delay, reduce, or terminate our ~~product~~clinical isdevelopment ~~used~~programs.

InAlthough ~~addition,~~we ~~the~~intend ~~U.S.~~to ~~government, state~~explore ~~legislatures~~other ~~and foreign governments have continued implementing cost-containment programs, including price controls, restrictions~~therapeutic onopportunities ~~coverage~~in ~~and~~addition ~~reimbursement~~to ~~and~~the ~~requirements~~product ~~for~~candidates ~~substitution~~that ofwe ~~generic~~are ~~products.~~currently ~~Adoption of price controls and cost-containment measures~~developing, ~~and~~ ~~adoption~~we ofmay ~~more~~fail ~~restrictive~~to ~~policies~~identify inviable ~~jurisdictions~~new ~~with existing controls and measures, could further limit sales of any~~ product. candidates ~~Decreases~~for inclinical ~~third-party~~development ~~reimbursement~~ for ~~any product or~~ a ~~decision~~number byof areasons. ~~third-party~~If ~~payor~~we ~~not~~fail to ~~cover~~identify aadditional ~~product~~potential ~~could reduce physician usage and patient demand for the~~ product ~~and~~candidates, ~~also~~our ~~have~~business acould ~~material~~be materially ~~adverse effect on sales~~harmed.

~~Healthcare~~Although ~~Reform~~a substantial amount of our efforts will focus on the planned clinical trials and potential approval of the current and potential future product candidates we are evaluating, we also intend to discover, develop, and globally commercialize additional targeted therapies beyond our current product candidates to treat various forms of cancer and in a variety of therapeutic areas. Even if we identify investigational therapies that initially show promise, we may fail to successfully develop and commercialize such products for many reasons, including the following:

~~Payors,~~● ~~whether~~the ~~domestic~~research ~~or foreign,~~methodology orused ~~governmental~~may ~~or private, are developing increasingly sophisticated methods of controlling healthcare costs and those methods are~~ not ~~always~~be ~~specifically~~successful ~~adapted~~in ~~for~~identifying ~~new~~potential ~~technologies~~investigational ~~such as gene therapy and~~ therapies addressing rare diseases such as those we are developing. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our products profitably.;

In● ~~the~~competitors ~~United~~may ~~States,~~develop inalternatives ~~March 2010,~~that ~~the~~render ~~Patient~~our ~~Protection~~investigational ~~and~~therapies Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, each as amended, collectively known as the ACA, was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly affected the pharmaceutical industry. The ACA contained a number of provisions, including those governing enrollment in federal healthcare programs, reimbursement adjustments and changes to fraud and abuse laws. For example, the ACA:obsolete;

● ~~increased~~investigational ~~the~~therapies ~~minimum~~we ~~level~~develop ofmay ~~Medicaid~~nevertheless ~~rebates~~be ~~payable~~covered by ~~manufacturers~~third ofparties’ ~~brand~~patents ~~name~~or ~~drugs~~other ~~from~~exclusive ~~15.1% to 23.1% of the average manufacturer price~~rights;

● ~~required~~an ~~collection~~investigational oftherapy ~~rebates~~may, ~~for~~on ~~drugs~~further ~~paid~~study, bybe ~~Medicaid~~shown ~~managed~~to ~~care~~have ~~organizations~~harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;

● ~~required~~it ~~manufacturers~~may totake ~~participate~~greater inhuman aand ~~coverage~~financial ~~gap~~resources ~~discount~~than ~~program,~~we ~~under~~will ~~which~~possess ~~they must now agree~~ to ~~offer~~identify ~~70%~~additional ~~point-of-sale~~therapeutic ~~discounts~~opportunities ~~off~~for ~~negotiated~~our ~~prices~~product ofcandidates ~~applicable~~or ~~brand~~to ~~drugs~~develop tosuitable ~~eligible~~potential ~~beneficiaries~~product ~~during~~candidates ~~their~~through ~~coverage~~internal ~~gap~~research ~~period~~programs, asthereby alimiting ~~condition~~our ~~for~~ability ~~the manufacturer’s outpatient drugs~~ to bedevelop, ~~covered~~diversify ~~under~~and ~~Medicare~~expand ~~Part~~our D;product ~~and~~portfolio;

● ~~imposed~~an ainvestigational ~~non-deductible~~therapy ~~annual~~may ~~fee~~not onbe ~~pharmaceutical~~capable ~~manufacturers~~of orbeing ~~importers~~produced ~~who~~in ~~sell~~clinical ~~“branded~~or ~~prescription~~commercial ~~drugs”~~quantities toat ~~specified~~an ~~federal~~acceptable ~~government~~cost, ~~programs.~~or at all; and

On● June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA. Prior to the Supreme Court’s decision, President Biden issued an ~~Executive~~approved ~~Order~~product tomay ~~initiate~~not abe ~~special~~accepted ~~enrollment~~as ~~period from~~safe ~~February 15, 2021 through August 15, 2021 for purposes of obtaining health insurance coverage through the ACA marketplace. The Executive Order also instructed certain governmental agencies to review~~ and ~~reconsider~~effective ~~their~~by ~~existing~~trial ~~policies and rules that limit access to healthcare~~participants, ~~including~~ among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ~~ACA.~~medical Itcommunity ~~is unclear how other healthcare reform measures of the Biden administrations~~ or ~~other~~third-party ~~efforts, if any, to challenge repeal or replace the ACA, will impact our business~~payors.

50Identifying new investigational therapies requires substantial technical, financial, and human resources, whether or not any investigational therapies are ultimately identified. Because we have limited financial and human resources, we may initially focus on research programs and product candidates for a limited set of indications. As a result, we may forgo or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. For example, if we do not accurately evaluate the commercial potential or target market for a particular product candidate or technology, we may relinquish valuable rights to that product candidate or technology through collaborations, licensing, or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate or technology.

~~Other legislative changes have been proposed and adopted in the United States since the Affordable Care Act was enacted. For example~~Accordingly, onthere ~~March~~can ~~11,~~be ~~2021, President~~no ~~Biden~~assurance ~~signed~~that ~~the~~we ~~American~~will ~~Rescue~~ever ~~Plan~~be ~~Act~~able ofto ~~2021~~identify ~~into~~additional ~~law,~~therapeutic ~~which~~opportunities ~~eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price,~~ for ~~single~~our ~~source~~product ~~and~~candidates ~~innovator~~or ~~multiple~~to ~~source~~develop ~~drugs, beginning January 1, 2024. Further,~~suitable inpotential ~~August~~product ~~2011,~~candidates the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through ~~2021,~~ ~~was~~internal ~~unable~~research ~~to reach required goals, thereby triggering the legislation’s automatic reduction to several government~~ programs, ~~including~~ ~~aggregate~~which ~~reductions~~could ofmaterially ~~Medicare~~adversely ~~payments~~affect toour ~~providers~~future ofgrowth 2%and ~~per fiscal year~~prospects. ~~These reductions went into effect in April 2013~~ ~~and,~~We ~~due~~may tofocus ~~subsequent~~our ~~legislative~~efforts ~~amendments to the statute, will remain in effect through 2030 unless additional action is taken by Congress. Pursuant to the Coronavirus Aid, Relief,~~ and ~~Economic~~resources ~~Security~~on ~~Act,~~potential ~~also~~product ~~known~~candidates asor ~~the~~other ~~CARES~~potential ~~Act,~~programs asthat ~~well~~ultimately asprove ~~subsequent legislation, these reductions have been suspended from May 1, 2020 through December 31, 2021 due~~ to ~~the~~be ~~COVID-19 pandemic~~unsuccessful.

Further, on May 30, 2018, the Right to Try Act was signed into law. The law, among other things, provides a federal framework for certain patients to access certain investigational new drug products that have completed a Phase 1 clinical trial and that are undergoing investigation for FDA approval. Under certain circumstances, eligible patients can seek treatment without enrolling in clinical trials and without obtaining FDA permission under the FDA expanded access program. There is no obligation for a pharmaceutical manufacturer to make its drug products available to eligible patients as a result of the Right to Try Act.32

~~Moreover,~~The ~~there~~occurrence ~~has~~of ~~recently~~serious complications ~~been~~or ~~heightened~~side ~~governmental~~effects ~~scrutiny over the manner~~ in ~~which~~connection ~~manufacturers~~with ~~set~~use ~~prices~~of ~~for~~our ~~their~~product ~~marketed products~~candidates, ~~which~~either ~~has resulted~~ in ~~several~~clinical ~~Congressional~~trials ~~inquiries,~~or ~~proposed and enacted legislation and executive orders issued by the previous administration designed to~~post-approval, ~~among~~could ~~other~~lead ~~things, bring more transparency~~ to ~~product~~discontinuation of ~~pricing,~~our ~~review~~clinical ~~the~~development ~~relationship between pricing and manufacturer patient~~ programs, ~~and~~ ~~reform~~refusal ~~government program reimbursement methodologies for drug products. The likelihood~~ of ~~success~~regulatory ofauthorities ~~these~~to ~~and~~approve ~~other~~our ~~measures~~product ~~initiated by~~candidates ~~the previous administration is uncertain~~or, ~~particularly in light of the new Biden administration. It is also possible that additional governmental action is taken in response to the COVID~~post-19approval, ~~pandemic. Individual states in the United States have also become increasingly~~revocation ~~active~~of inmarketing ~~implementing~~authorizations ~~regulations~~or ~~designed~~refusal to ~~control~~approve ~~pharmaceutical~~applications ~~product~~for ~~pricing,~~new ~~including price or patient reimbursement constraints~~indications, ~~discounts,~~ ~~restrictions~~which oncould ~~certain~~severely ~~product~~harm ~~access~~our ~~and marketing cost disclosure and transparency measures~~business, ~~and~~prospects, ~~in some cases, designed~~ tooperating ~~encourage~~results ~~importation from other countries~~ and ~~bulk~~financial ~~purchasing~~condition.

~~Data~~Undesirable ~~Privacy~~side effects caused by any of our current or potential future product candidates could cause regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities. ~~Security~~It ~~Laws~~is likely that there will be side effects associated with their use. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of these side effects. It is possible that safety events or concerns such as these or others could negatively affect the development of our product candidates, including adversely affecting patient enrollment among the patient populations that we intend to treat. In such an event, our trials could be suspended or terminated, and the FDA or other regulatory authorities could order us to cease further development of or deny approval of a product candidate for any or all targeted indications. Such side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. There can be no guarantee that our current or future product candidates will not cause such effects in clinical trials. Any of these occurrences may materially and adversely affect our business and financial condition and impair our ability to generate revenues.

WeFurther, ~~also are or will become subject to privacy laws in the jurisdictions in which we are established or in which we sell or market our products or run~~ clinical trials. by ~~For~~their ~~example,~~nature inutilize ~~Europe~~a wesample ~~are~~of ~~subject to~~ the ~~GDPR~~potential inpatient ~~relation~~population. toWith ~~our~~a ~~collection,~~limited ~~control,~~number ~~processing~~of patients and ~~other~~limited ~~use~~duration of ~~personal data (i.e.~~exposure, ~~data~~rare ~~relating~~and tosevere anside ~~identifiable~~effects ~~living~~of ~~individual).~~a Weproduct ~~process~~candidate ~~personal~~may ~~data~~only inbe ~~relation~~uncovered towhen ~~participants~~a insignificantly ~~our~~larger ~~clinical~~number ~~trials in the EEA, including health and medical information~~ of ~~these~~patients ~~participants.~~are ~~The~~exposed ~~GDPR also provides that individual EEA countries may introduce~~to ~~further~~the ~~conditions~~product ofcandidate ~~their~~or ~~own,~~when ~~including~~patients ~~limitations~~are ~~which~~exposed ~~could~~for ~~limit~~a ~~our~~longer ~~ability~~period toof ~~collect, use and share personal data~~time.

~~The~~In ~~GDPR~~the ~~imposes~~event ~~onerous~~that ~~accountability obligations~~any ~~requiring data controllers and processors to maintain a record~~ of ~~their data processing and implement policies as part of~~our ~~its~~current ~~mandated~~or ~~privacy~~potential ~~governance~~future ~~framework.~~product Itcandidates ~~also~~receives ~~requires~~regulatory ~~data~~approval ~~controllers to be transparent~~ and ~~disclose~~we toor ~~data~~others ~~subjects~~identify ~~(in~~undesirable aside ~~concise,~~effects caused ~~intelligible~~by ~~and~~one ~~easily accessible form) how their personal information is to be used; imposes limitations on retention~~ of ~~personal~~these ~~data; defines pseudonymized (i.e.~~products, ~~key-coded)~~any data; introduces mandatory data breach notification requirements; and sets higher standards for data controllers to demonstrate that they have obtained valid consent for certain data processing activities. Fines for certain breaches of the ~~GDPR~~following ~~are~~events ~~significant: up to the greater of €20 million or 4% of total global annual turnover. A breach of the GDPR or other applicable privacy and data protection laws and regulations~~ could ~~also result in regulatory investigations~~occur, reputational damage, orders to cease/change our use of data, enforcement notices, or potential civil claims including class action type litigation. Further, from January 1, 2021, we have to comply with the GDPR and separately the UK GDPR, which, ~~together~~could ~~with~~result ~~the amended UK Data Protection Act 2018, retains the GDPR~~ in ~~UK national law. The GDPR and~~ the UKloss ~~GDPR each have the ability to fine up to the greater~~ of ~~€20~~significant ~~million/£17 million~~revenue ~~or 4% of global turnover. Further, the relationship between the United Kingdom and the European Union in relation~~ to ~~certain~~us ~~aspects of data protection law remains unclear, including how data transfers between European Union member states~~ and ~~the United Kingdom will~~materially ~~be treated~~ and ~~how~~adversely ~~United~~affect ~~Kingdom~~our ~~data~~results ~~protection~~of ~~laws~~operations and regulations will develop in the medium to longer term. Currently there is a four to six-month grace period agreed in the European Union and United Kingdom Trade and Cooperation Agreement, ending June 30, 2021 at the latest, whilst the parties discuss an adequacy decision. The European Commission published a draft adequacy decision on February 19, 2021. If adopted, the decision will enable data transfers from European Union member states to the United Kingdom for a four-year period, subject to subsequent extensions. These changes may lead to additional compliance costs and could increase our overall risk.business:

51● regulatory authorities may withdraw their approval of the product or seize the product;

In● addition, the GDPR places restrictions on cross-border data transfers. Certain aspects of cross-border data transfers under the GDPR are uncertain as the result of legal proceedings in the European Union, including a recent decision by the Court of Justice for the European Union that invalidated the EU-U.S. Privacy Shield and, to some extent, called into question the efficacy and legality of using standard contractual clauses. This may increase the complexity of transferring personal data across borders. The GDPR will increase our responsibility and liability in relation to personal data that we ~~process where such processing is subject to the GDPR, and we~~ may be required to ~~put~~recall ~~in place additional mechanisms to ensure compliance with~~ the ~~GDPR,~~product including as implemented by individual countries. We are also subject to European Union rules with respect to cross-border transfers of personal data out of the EEA. Recent legal developments in the European Union have created complexity and uncertainty regarding transfers of personal data from the EEA to other countries whose data protection standards have not been deemed “adequate” by the European Commission (including the United States). On July 16, 2020, the Court of Justice of the European Union, or ~~CJEU,~~change ~~invalidated~~ the ~~EU-US~~way ~~Privacy Shield Framework, or Privacy Shield, under which personal data could be transferred from~~ the ~~EEA~~product tois USadministered ~~entities who had self-certified under the Privacy Shield scheme. While the CJEU upheld the adequacy, subject~~ to certain conditions, of the standard contractual clauses (a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism), future regulatory guidance could result in changes to the use of standard contractual clauses. As supervisory authorities issue further guidance on personal data export mechanisms, including circumstances where the standard contractual clauses cannot be used, and/or start taking enforcement action, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results.patients;

~~Further,~~● ~~the~~additional ~~exit~~restrictions ofmay ~~the~~be ~~United Kingdom,~~imposed ~~or UK, from the European Union, often referred to as Brexit, has created uncertainty with regard to data protection regulation in the UK. Specifically, the UK exited the European Union~~ on ~~January 1, 2020, subject to a transition period that ended December 31, 2020. Under~~ the ~~post-Brexit~~marketing ~~Trade and Cooperation Agreement between the European Union and the UK, the UK and European Union have agreed that transfers~~ of ~~personal data to~~ the UKparticular ~~from~~product ~~EEA member states will not be treated as ‘restricted transfers’ to a non-EEA country for a period of up to four months from January 1, 2021, plus a potential further two months extension,~~ or the ~~Extended~~manufacturing ~~Adequacy~~processes ~~Assessment Period. Although the current maximum duration of the Extended Adequacy Assessment Period is six months, it may end sooner,~~ for ~~example, in~~ the ~~event~~product ~~that the European Commission adopts an adequacy decision in respect of the UK,~~ or ~~the~~any UKcomponent amends the UK GDPR and/or makes certain changes regarding data transfers under the UK GDPR/Data Protection Act 2018 without the consent of the European Union (unless those amendments or decisions are made simply to keep relevant UK laws aligned with the European Union’s data protection regime). If the European Commission does not adopt an ‘adequacy decision’ in respect of the UK prior to the expiry of the Extended Adequacy Assessment Period, from that point onwards the UK will be an ‘inadequate third country’ under the GDPR and transfers of personal data from the EEA to the UK will require a ‘transfer mechanism’ such as the Standard Contractual Clauses.thereof;

In● ~~the~~we United States, numerous federal and state laws and regulations, including data breach notification laws, health information privacy and security laws, including HIPAA, and federal and state consumer protection laws and regulations (e.g., Section 5 of the Federal Trade Commission Act) that govern the collection, use, disclosure, and protection of health-related and other personal information could apply to our operations or the operations of our partners. In addition, certain state laws govern the privacy and security of personal information, including health-related information in certain circumstances, some of which are more stringent than HIPAA and many of which differ from each other in significant ways and may ~~not~~be ~~have~~subject the same effect, thus complicating compliance efforts. For example, California enacted the CCPA, which creates individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling certain personal data of consumers or households. The CCPA requires covered companies to ~~provide new disclosure to consumers about such companies’ data collection~~fines, ~~use and sharing practices~~injunctions, ~~provide such consumers new ways to opt-out of certain sales~~ or transfers of personal information, and provide consumers with additional causes of action. The CCPA provides for civil penalties for violations, as well as a private right of action for certain data breaches that result in the ~~loss~~imposition of personal information. This private right of action may increase the likelihood of, and risks associated with, data breach litigation. The CCPA became effective on January 1, 2020, and (a) allows the California Attorney General to impose civil penalties for violations and (b) authorizes private lawsuits to recover statutory damages for certain data breaches. In addition, laws in all 50 U.S. states require businesses to provide notice to consumers whose personal information has been disclosed as a result of a data breach. State laws are changing rapidly and there is discussion in the U.S. Congress of a new comprehensive federal data privacy law to which we would become subject if it is enacted. The CCPA may impact our business activities and exemplifies the vulnerability of our business to the evolving regulatory environment related to personal data and protected health information. Additionally, a new privacy law, the California Privacy Rights Act, or ~~CPRA,~~criminal recently passed in California. The CPRA significantly modifies the CCPA and imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data. It will also expand the types of data breaches subject to the CCPA’s private right of action, provide for increased penalties for CPRA violations concerning California residents under the age of 16 and create a new California data protection agency authorized to issue substantive regulations, and could result in increased privacy and information security enforcement. The majority of the provisions will go into effect on January 1, 2023, and additional compliance investment and potential business process changes may be required. Ensuring compliance with the CPRA could require us to incur additional costs and expenses.;

52● regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;

In● ~~order to distribute products commercially,~~ we ~~must~~may ~~comply~~be ~~with~~required ~~state~~to ~~laws~~create ~~that require the registration of manufacturers and wholesale distributors of pharmaceutical products in~~ a ~~state,~~medication ~~including,~~guide inoutlining ~~certain states, manufacturers and distributors who ship products into~~ the ~~state~~risks ~~even~~of if such ~~manufacturers or~~side ~~distributors~~effects ~~have~~for ~~no place of business within the state. Some states also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of~~ distribution, ~~including some states that require manufacturers and others~~ to adopt new technology capable of tracking and tracing product as it moves through the distribution chain. Several states have enacted legislation requiring pharmaceutical companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, track and report gifts, compensation and other remuneration made to physicians and other healthcare providers, clinical trials and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical companies for use in sales and marketing, and to prohibit certain other sales and marketing practices. All of our activities are potentially subject to federal and state consumer protection and unfair competition laws.patients;

If● ~~our operations are found to be in violation of any of the federal and state healthcare and privacy laws described above or any other governmental regulations that apply to us,~~ we ~~may~~could be ~~subject~~sued ~~to penalties, including without limitation, civil, criminal~~ and~~/or~~ ~~administrative~~held ~~penalties,~~liable ~~damages,~~for fines, disgorgement, imprisonment, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions, private “qui tam” actions brought by individual whistleblowers in the name of the government, or refusal to allow us to enter into government contracts, contractual damages, reputational harm, ~~administrative~~caused ~~burdens, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely affect our ability~~ to operate our business and our results of operations. For information regarding risks related to these compliance requirements, see the section titled “Risk Factors — Risks Related to Government Regulation.”patients;

~~Material~~● ~~Agreements~~the product may become less competitive; and

~~Services~~● ~~Agreement~~our reputation may suffer.

~~Pursuant~~Any toof ~~the~~these ~~Services~~events ~~Agreement, we~~could ~~agreed to (i) pay Eureka $10,000,000 in connection with the services thereunder payable in 12 equal monthly installments and (ii) reimburse~~prevent ~~Eureka~~us onfrom aachieving ~~monthly basis for reasonable pass-through costs incurred~~ or ~~paid~~maintaining tomarket ~~providers~~acceptance byof ~~Eureka in providing~~ the ~~services.~~particular Inproduct ~~addition~~candidate, we ~~will~~if beapproved, ~~charged~~and ~~for~~could ~~other~~significantly ~~services~~harm ~~performed by Eureka outside the scope of the services set forth in the Services Agreement, at a~~our ~~flat rate~~business, byresults ~~time or materials or as mutually agreed upon the parties in writing. As~~ of ~~June~~operations ~~30, 2024, we had paid Eureka $10,000,000 for the IND Application Services~~ and ~~$117,920 of pass-through costs for services provided pursuant to the Services Agreement~~prospects.

53While our IND for EB103 was cleared by the FDA on March 2, 2023 and we believe our pipeline will yield additional INDs, we may not be able to file additional INDs to commence clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.

~~Statement~~While we expect our pipeline to yield multiple INDs in addition to the IND for EB103, which was cleared by the FDA on March 2, 2023, we cannot be sure that submission of ~~Work~~future ~~#001~~INDs will result in the FDA allowing testing and clinical trials to begin, or that, once clinical trials for our product candidates begin, issues will not arise that suspend or terminate such clinical trials. For our ongoing STARLIGHT-1 trial of EB103, we have completed the second dose cohort in the Phase I dose-escalation portion of the study, and an independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from the Phase I dose-escalation phase (n=9) and recommended advancing the trial into the Phase II expansion phase at the recommended Phase II dose. In the Phase I portion of STARLIGHT-1, no treatment-related serious adverse events were reported, and the high-dose cohort achieved a 100% complete response rate at Month 1 in all evaluable patients, including high-risk patients who were not eligible for currently available commercial CD19 products, such as a patient with CNS lymphoma. However, these data are based on a small number of patients and early-stage observations, and they may not be predictive of results in larger patient populations or later-stage trials. In addition, the manufacturing of our additional product candidates remains an emerging and evolving field. Accordingly, we expect chemistry, manufacturing and controls (CMC) topics, including product specifications, release criteria and comparability, to be a focus of IND reviews and ongoing regulatory interactions, which may delay the clearance of future INDs or restrict or delay the conduct of our clinical trials.

~~Pursuant~~Additionally, toeven ~~the~~if ~~Statement~~regulatory ofauthorities ~~Work~~initially ~~#001,~~agree ~~effective~~with ~~March 4, 2024, as amended, we committed to paying Eureka $33,000,000 for services related to~~ the ~~Phase~~design ~~I/II~~and ~~clinical trial~~implementation of ~~EB103,~~clinical atrials ~~T-cell~~described ~~therapy~~in ~~targeting~~an ~~CD19~~IND ~~using~~or ~~ARTEMIS®~~clinical ~~T-cell~~trial ~~technology. As of June 30~~application, ~~2024, Estrella has paid $3,500,000~~we tocannot ~~Eureka~~guarantee ~~for the fees associated with milestones achieved. The amended SOW clarifies~~ that, ifsuch ~~Estrella~~regulatory ~~exercises~~authorities ~~its right to terminate or suspend the engagement with Eureka by providing written notice, Estrella~~ will ~~only~~not bechange ~~obligated~~their torequirements ~~compensate Eureka for (i) services provided~~ in ~~connection with milestones achieved prior to~~ the ~~termination notice~~future, ~~(ii)~~require ~~reasonable~~us ~~and documented pass-through costs incurred prior~~ to ~~the~~modify ~~termination~~trial ~~notice~~design, add ~~and~~new ~~(iii)~~endpoints ~~amounts~~or ~~payable~~safety ~~to third parties for commitments reasonably entered into prior to the termination notice~~monitoring, ~~provided~~or ~~that~~impose ~~Eureka~~additional ~~makes~~pauses ~~commercially reasonable efforts to cancel~~ or ~~reduce such commitments~~holds.

~~Collaboration Agreement~~33

AnIn ~~overview~~addition to the submission of an IND to the ~~Collaboration~~FDA before initiation of a clinical trial in the United States, certain human clinical trials ~~Agreement~~involving ~~with~~recombinant ~~Imugene~~or issynthetic ~~provided~~nucleic ~~above~~acid molecules are subject to oversight by institutional biosafety committees (“IBCs”) under the National Institutes of Health (“~~Business~~NIH”) —Guidelines ~~CF33-CD19t~~for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (the “NIH Guidelines”). Under the NIH Guidelines, research involving the deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from such molecules, into human subjects (human gene transfer) requires IBC approval and other applicable regulatory authorizations before initiation. Our EB103 and other ARTEMIS® T-cell product candidates are generated using lentiviral vectors and therefore involve the introduction of recombinant or synthetic nucleic acid molecules into human subjects, which is considered human gene transfer under these guidelines.” As a result, our clinical trials may be subject to IBC review and approval at each participating institution, in addition to institutional review board (IRB) and FDA requirements. The IBC assesses the safety of the research and identifies any potential risk to public health or the environment, and its review and any associated biosafety requirements may result in additional time, cost and complexity before sites can be activated or patients can be enrolled, and may delay the initiation or conduct of our clinical trials. While the NIH Guidelines are only mandatory for institutions that receive certain types of NIH funding, many institutions, sponsors and CROs voluntarily follow them, and we expect that our gene-transfer studies will generally be required to comply with IBC oversight.

~~License~~Interim, ~~Agreement~~topline and preliminary data that we announce or publish from time to time for any clinical trials that we initiate may change as more patient data become available or as additional analyses are conducted, and as the data are subject to audit and verification procedures that could result in material changes in the final data.

AnFrom ~~overview~~time to time, we may publicly disclose interim, preliminary, or topline data from our preclinical studies and clinical trials, which is based on a preliminary analysis of then-available data, and the ~~License~~results and related findings and conclusions are subject to change following a more comprehensive review ~~Agreement~~of the data related to the particular trial. We also make assumptions, estimations, calculations, and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, preliminary, or topline results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with ~~Eureka~~caution isuntil ~~provided~~the ~~above~~final ~~under~~data ~~“Business~~are —available. ~~Intellectual~~From ~~Property~~time to time, we may also disclose interim, preliminary, or topline data from our clinical studies.” 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 more patient data become available. Adverse differences between preliminary, topline, or interim data and final data could significantly harm our business prospects.

~~Facilities~~Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions, or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and the value of 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 you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product, product candidate or our business. If the topline data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects, or financial condition.

~~Our~~We ~~corporate~~and ~~headquarters are~~our ~~located~~collaborators inmay ~~Emeryville,~~not ~~California.~~achieve projected Wediscovery ~~believe~~and ~~that~~development ~~our~~milestones ~~existing~~and ~~facilities~~other ~~are~~anticipated ~~adequate~~key ~~for~~events ~~our~~in ~~near-term~~the ~~needs~~time ~~but~~frames ~~expect~~that ~~to need additional space as~~ we ~~grow.~~or Wethey ~~believe~~announce, ~~that~~which ~~suitable~~could have ~~additional~~an oradverse ~~alternative~~impact ~~space~~on ~~would~~our bebusiness ~~available~~and ascould ~~required~~cause inour ~~the~~stock ~~future~~price ~~on commercially~~to ~~reasonable terms~~decline.

~~Employees~~From time to time, we expect that we will make public statements regarding the expected timing of certain milestones and key events, such as the commencement and completion of preclinical and IND-enabling studies in our product candidate discovery programs with collaborators as well as the commencement and completion of planned clinical trials in those programs. The actual timing of these events can vary dramatically due to a number of factors such as delays or failures in our or any current or future collaborators’ product candidate discovery and development programs, the amount of time, effort and resources committed by us and any current or future collaborators, and the numerous uncertainties inherent in the development of therapies. As a result, there can be no assurance that our or any current or future collaborators’ programs will advance or be completed in the time frames we or they announce or expect. If we or any collaborators fail to achieve one or more of these milestones or other key events as planned, our business could be materially adversely affected, and the price of our Common Stock could decline.

~~Most~~Clinical oftrials ~~our~~are ~~day-to-day~~expensive, ~~operations~~time-consuming, ~~to date have been related to preparing for the Business Combination~~ and ~~technology~~difficult ~~research and development. Many of the operational tasks that we require are managed by Eureka pursuant~~ to ~~the~~design ~~Services Agreement~~ and ~~SOW~~implement. ~~As a result, we have a limited number of employees and do not expect to hire a significant number of new employees in the near future.~~

~~Other~~Human ~~Information~~clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements. Because our current and potential future product candidates are based on new technologies and discovery approaches, we expect that they will require extensive research and development and have substantial manufacturing and processing costs. In addition, the FDA or other regulatory authorities may require us to perform additional testing before commencing clinical trials and be hesitant to allow us to enroll patients impacted with our targeted disease indications in our future clinical trials. If we are unable to enroll patients impacted by our targeted disease indications in our future clinical trials, we would be delayed in obtaining potential proof-of-concept data in humans, which could extend our development timelines. In addition, costs to treat patients and to treat potential side effects that may result from our product candidates may be significant. Accordingly, our clinical trial costs are likely to be high and could have a material adverse effect on our business, financial condition, results of operations and prospects.

Estrella Immunopharma, Inc. files reports with the Securities and Exchange Commission (SEC), including annual reports on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available on the SEC’s website at www.sec.gov. Estrella’s own website www.estrellabio.com also provides access to these reports free of charge as soon as reasonably practicable after filing with the SEC.34

54If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

~~Item~~We 1Amay not be able to initiate or continue any clinical trials for our current or potential future product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or other regulatory authorities. ~~Risk~~We ~~Factors~~cannot predict how difficult it will be to enroll patients for trials in the indications we are studying. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The enrollment of patients depends on many factors, including:

~~You~~● ~~should consider carefully~~ the ~~risks~~severity ~~and uncertainties described below, together with all~~ of the ~~other~~disease ~~information~~under contained in this Annual Report. If any of the following events occur, our business, financial condition and operating results may be materially adversely affected. In that event, the trading price of our securities could decline, and you could lose all or part of your investment. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that adversely affect our business or results of operations. For a summary of these Risk Factors, see “Summary Risk Factors.”investigation;

~~Risks~~● ~~Related~~patient toeligibility ~~the~~criteria ~~Equity Subscription~~defined ~~Line~~in ~~and Shares Sold by~~ the ~~Selling~~clinical ~~Stockholders~~trial protocol;

It● ~~is not possible to predict~~ the ~~actual~~size ~~number~~ of ~~shares of Common Stock, if any, we will sell under~~ the ~~Common~~patient ~~Stock~~population ~~Purchase~~required ~~Agreement~~for toanalysis ~~White~~of ~~Lion or~~ the ~~actual~~trial’s ~~gross~~primary ~~proceeds resulting from those sales.~~endpoints;

On● ~~April 14, 2023, we entered into~~ the ~~Common~~proximity ~~Stock~~and ~~Purchase~~availability ~~Agreement, pursuant to which White Lion has committed to purchase up to the lesser~~ of ~~(i)~~clinical ~~$50,000,000~~trial ~~in aggregate~~sites ~~gross~~for ~~purchase~~prospective ~~price of newly issued shares of Common Stock and (ii) the Exchange Cap, in each case, subject to certain limitations and conditions set forth in the Common Stock Purchase Agreement.~~patients;

~~Subject~~● towillingness ~~the satisfaction~~ of ~~certain~~physicians ~~customary conditions including, Estrella’s right~~ to ~~sell~~refer ~~shares~~their topatients ~~White Lion commenced on July 11, 2023 and extend until December 31, 2024. During such term, subject~~ to ~~the~~our ~~terms~~clinical ~~and conditions of the Common Stock Purchase Agreement, Estrella shall notify White Lion when Estrella exercises its right, in its sole discretion, to sell shares.~~trials;

We● ~~generally have the right to control the timing and amount of any sales of~~ our ~~shares~~ability ~~of Common Stock~~ to ~~White~~recruit ~~Lion~~clinical ~~under~~trial ~~the~~investigators ~~Common~~with ~~Stock Purchase Agreement. Sales of our shares of Common Stock, if any, to White Lion under~~ the ~~Common~~appropriate ~~Stock~~competencies ~~Purchase Agreement will depend upon market conditions~~ and ~~other~~ factors to be determined by us. We may ultimately decide to sell to White Lion all, some or none of the shares of Common Stock that may be available for us to sell to White Lion pursuant to the Common Stock Purchase Agreement.experience;

~~Because~~● ~~the~~clinicians’ ~~purchase~~and ~~price per~~patients’ ~~share~~perceptions ofas ~~Common Stock~~ to ~~be paid by White Lion for~~ the ~~shares~~potential ofadvantages ~~Common Stock that we may elect to sell to White Lion under the Common Stock Purchase Agreement, if any, will fluctuate based on the market prices~~ of the ~~Common~~product ~~Stock~~candidate atbeing ~~the~~studied ~~time~~in werelation ~~elect~~ to ~~sell~~other ~~shares~~available ~~of Common Stock to White Lion pursuant to the Common Stock Purchase Agreement~~therapies, ifincluding any, itnew isdrugs ~~not possible for us to predict, prior to any such sales, the number of shares of Common Stock~~ that wemay ~~will~~be ~~sell~~approved ~~to White Lion under the Common Stock Purchase Agreement, the purchase price per share that White Lion will pay~~ for ~~shares of Common Stock purchased from us under~~ the ~~Common~~indications ~~Stock Purchase Agreement, or the aggregate gross proceeds that~~ we ~~will~~are ~~receive from those purchases by White Lion under the Common Stock Purchase Agreement.~~investigating;

~~The~~● ~~number~~our ofability ~~shares of Common Stock ultimately offered for sale by White Lion is dependent upon the number of shares of Common Stock, if any, we ultimately elect~~ to ~~sell~~ toobtain White Lion under the Common Stock Purchase Agreement. However, even if we elect to sell shares of Common Stock to White Lion pursuant to the Common Stock Purchase Agreement, White Lion may resell all, some or none of such shares at any time or from time to time in its sole discretion and atmaintain ~~different~~patient ~~prices.~~consents;

~~Because~~● the ~~market~~risk ~~price of our shares of Common Stock may fluctuate from time to time, the actual purchase price to be paid by White Lion for our shares of Common Stock~~ that wepatients ~~elect~~enrolled toin ~~sell~~clinical totrials ~~White Lion under the Common Stock Purchase Agreement, if any, also may fluctuate because they~~ will bedrop ~~based on~~out ~~such fluctuating market price~~ of ~~our shares of Common Stock, it is possible that we would need to issue and sell more than~~ the ~~number of~~trials ~~shares~~before ofcompletion; ~~Common Stock that were registered for resale by White Lion in order to receive aggregate gross proceeds of $50.0 million under the Common Stock Purchase Agreement.~~and

55● factors we may not be able to control, such as current or potential pandemics, that may limit the availability of patients, principal investigators or staff or clinical sites to participate in our clinical trials.

~~Accordingly~~In addition, ifour ~~it becomes~~future ~~necessary~~clinical ~~for~~trials uswill tocompete ~~issue~~with ~~and~~other ~~sell~~clinical totrials ~~White~~for ~~Lion~~product ~~under~~candidates that are in the ~~Common~~same ~~Stock~~therapeutic ~~Purchase~~areas ~~Agreement~~as ~~more~~our ~~than~~product candidates, and this competition will reduce the ~~7,036,726~~number ~~shares~~and types of ~~Common~~patients ~~Stock that~~available ~~were~~to ~~registered~~us, ~~for~~because ~~resale,~~some inpatients ~~addition~~who might have opted to ~~obtaining~~enroll ~~stockholder~~in ~~approval~~our totrials ~~exceed~~may ~~the~~instead ~~Exchange~~opt ~~Cap~~to enroll in ~~accordance~~a ~~with~~trial ~~Nasdaq~~being ~~listing rules,~~conducted weby ~~must~~one ~~file~~of ~~with~~our competitors. Since the ~~SEC~~number ~~one~~of qualified orclinical ~~more~~investigators ~~additional~~is ~~registration~~limited, ~~statements~~we expect to ~~register~~conduct ~~under~~some ~~the~~of ~~Securities~~our ~~Act~~clinical trials at the ~~resale~~same byclinical ~~White~~trial sites that ~~Lion~~some of ~~any~~our ~~such~~competitors ~~additional~~use, ~~shares~~which ofwill ~~Common~~reduce ~~Stock~~the wenumber ~~wish~~of topatients ~~sell~~who ~~from~~are ~~time~~available tofor ~~time~~our ~~under~~clinical ~~the~~trials ~~Common~~at ~~Stock~~such ~~Purchase~~clinical trial ~~Agreement~~sites. Additionally, ~~which the~~because ~~SEC~~some ~~must~~of ~~declare~~our ~~effective,~~clinical trials will be in ~~each~~patients ~~case~~with ~~before~~advanced wedisease who may ~~elect~~experience todisease progression ~~sell~~or ~~any~~adverse ~~additional~~events ~~shares~~independent offrom ~~Common~~our ~~Stock~~product tocandidates, ~~White~~such ~~Lion~~patients ~~under~~may ~~the Common~~be ~~Stock~~unevaluable ~~Purchase~~for ~~Agreement.~~purposes ~~Any~~of ~~issuance~~the trial and, ~~sale~~as bya usresult, ~~under~~we ~~the~~may ~~Common~~require ~~Stock~~additional ~~Purchase~~enrollment. ~~Agreement~~Delays ofin apatient ~~substantial~~enrollment ~~amount~~may ofresult ~~shares of~~in ~~Common~~increased ~~Stock~~costs inor ~~addition~~may toaffect the timing ~~7,036,726~~or ~~shares~~outcome of ~~Common~~the ~~Stock~~planned ~~being~~clinical ~~registered~~trials, ~~for~~which ~~resale~~could byprevent ~~White~~completion ~~Lion~~of ~~could~~these ~~cause~~trials ~~additional~~and ~~substantial dilution~~adversely affect our ability to advance the development of our ~~stockholders~~product candidates.

~~The~~If ~~sale~~clinical ~~and~~trials ~~issuance of~~for ~~shares~~our ofproduct ~~Common~~candidates are ~~Stock~~prolonged, todelayed, ~~White~~or ~~Lion~~stopped, ~~will~~we ~~cause~~may ~~dilution~~be unable to ~~our~~seek ~~existing~~or ~~securityholders,~~obtain ~~and~~regulatory ~~the~~approval ~~resale~~and ofcommercialize ~~the~~our ~~shares~~product ofcandidates ~~Common Stock~~on bya ~~White~~timely ~~Lion~~basis, or ~~the~~at ~~perception~~all, ~~that~~which ~~such~~would ~~resales~~require ~~may~~us ~~occur,~~to ~~could~~incur ~~cause~~additional ~~the~~costs ~~price~~and ofdelay our ~~securities~~receipt toof ~~fall~~any product revenue.

~~The~~We ~~purchase~~may ~~price~~experience ~~per~~delays ~~share~~in ofour ~~Common~~ongoing ~~Stock~~or tofuture bepreclinical ~~paid~~studies byor ~~White~~clinical ~~Lion~~trials, ~~for~~and ~~the shares of Common Stock that~~ we ~~may~~do ~~elect~~not toknow ~~sell~~whether tofuture ~~White~~preclinical ~~Lion~~studies ~~under~~or ~~the~~clinical ~~Common Stock~~trials ~~Purchase Agreement, if any,~~ will ~~fluctuate~~begin ~~based~~ on ~~the market prices of our shares of Common Stock at the~~ time, weneed ~~elect~~ to ~~sell~~be ~~shares of~~redesigned, ~~Common~~enroll ~~Stock~~an toadequate ~~White~~number ~~Lion~~of ~~pursuant~~patients toon ~~the~~time, ~~Common~~or ~~Stock~~be ~~Purchase~~completed ~~Agreement. Depending~~ on ~~market~~schedule, ~~liquidity~~if at ~~the~~all. ~~time,~~The commencement ~~resales~~or ofcompletion ~~such shares~~ of ~~Common~~these ~~Stock~~clinical bytrials ~~White~~could ~~Lion~~be ~~may~~substantially ~~cause~~delayed ~~the~~or ~~trading~~prevented ~~price~~by ofmany ~~our~~factors, ~~shares of Common Stock to fall.~~including:

If● ~~and~~further ~~when~~discussions wewith ~~elect to sell shares of Common Stock to White Lion, sales of newly issued shares of Common Stock by us to White Lion could result in substantial dilution to~~ the ~~interests~~FDA ofor ~~existing~~comparable ~~holders~~foreign ofregulatory ~~our~~authorities ~~shares~~regarding ~~of Common Stock. If all of~~ the ~~7,036,726~~scope ~~shares~~or ofdesign ~~Common Stock offered for resale by White Lion (without regard to the $50.0 million aggregate purchase price limit pursuant to the Common Stock Purchase Agreement) were issued and outstanding as~~ of ~~the Closing, such shares of Common Stock would represent approximately 19.99% of the total number of~~ our ~~shares~~ ofclinical ~~Common Stock outstanding as of the Closing Date. Additionally~~trials, ~~the~~including ~~sale of a substantial number of shares of Common Stock to White Lion, or~~ the ~~anticipation~~endpoint ofmeasures ~~such~~required ~~sales, could make it more difficult~~ for usregulatory toapproval ~~sell equity or equity-related securities in the future at a time~~ and atour astatistical ~~price that we might otherwise wish to effect sales.~~plan;

~~Investors who buy shares of Common Stock from White Lion at different times will likely pay different prices.~~35

~~Pursuant~~● to the ~~Common~~limited ~~Stock Purchase~~number ~~Agreement~~of, ~~we will have discretion to vary the timing, price~~ and ~~number~~competition ~~of shares sold to White Lion~~for, ifsuitable ~~any.~~study Ifsites and ~~when~~investigators ~~we elect~~ to ~~sell~~conduct ~~shares~~our ofclinical ~~Common Stock to White Lion pursuant to the Common Stock Purchase Agreement~~trials, ~~after~~many ~~White Lion has acquired such shares~~ of ~~Common~~which ~~Stock, White Lion~~ may ~~resell~~already ~~all,~~be ~~some~~engaged ~~or none of such shares at any time or from time to time~~ in ~~its~~other ~~sole~~clinical ~~discretion and~~trial atprograms ~~different~~with ~~prices.~~similar ~~As a result~~patients, ~~investors~~including ~~who purchase shares from White Lion at different times will likely pay different prices for those shares, and so may experience different levels of dilution and in~~ some ~~cases~~that ~~substantial dilution and different outcomes in their investment results. Investors~~ may ~~experience~~be afor ~~decline in~~ the ~~value~~same ofindications ~~the shares they purchase from White Lion in this offering~~ as a result of future sales made by us to White Lion at prices lower than the prices such investors paid for their shares in this offering. In addition, if we sell a substantial number of shares to White Lion under the Common Stock Purchase Agreement, or if investors expect that we will do so, the actual sales of shares or the mere existence of our ~~arrangement~~product ~~with White Lion may make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect such sales.~~candidates;

~~Sales~~● ofany adelay ~~substantial number~~or offailure ~~our~~to ~~securities~~obtain intimely ~~the~~approval ~~public market by the Selling Stockholders~~ or byagreement ~~our~~to ~~other~~commence ~~existing~~a ~~securityholders~~clinical ~~could~~trial ~~cause~~in ~~the~~any ~~price~~ of ~~our~~the ~~Common~~countries ~~Stock~~where ~~and~~enrollment ~~Warrants~~is ~~to fall.~~planned;

~~The~~● ~~shares~~inability that were registered for resale represent approximately 37.2% of our total outstanding shares as of the Closing Date. The sale or availability for sale of these shares could adversely affect the prevailing market price of our Common Stock and could impair our ability to ~~raise~~obtain ~~capital~~sufficient ~~through future~~funds ~~sales~~required of our securities. In addition, the PIPE investors who acquired the shares being registered pursuant to the Subscription Agreements purchased their shares at a price of $4.15 per share, the Selling Stockholders who hold an aggregate of 240,000 Founder Shares acquired at a purchase price of $0.001 per share, and the Selling Stockholders who hold an aggregate of 867,500 Founder Shares acquired at a purchase price of $0.022 per share, each of which is significantly lower than the initial public offering price of $10.00 per share of our Common Stock. Therefore, these Selling Stockholders may have an incentive to sell their shares before our public stockholders who purchased shares in the initial public offering, because they could still realize a profit even if the market price of our Common Stock is below the initial public offering price of our Common Stock. For example, on December 14, 2023, our Common Stock closed at $1.25 per share on the Nasdaq Capital Market. If the Selling Stockholders who hold an aggregate of 240,000 Founder Shares acquired for ~~$0.001 per share sold any of their Founder Shares at this price, they would realize~~ a ~~profit~~clinical of $1.249 per share and an aggregate profit of $299,760 if they each sold all of their Founder Shares. If the Selling Stockholders who hold an aggregate of 867,500 Founder Shares acquired for $0.022 per share sold any of their Founder Shares at this price, they would realize a profit of $1.228 per share and an aggregate profit of $1,065,290 if they each sold all of their Founder Shares. Such sales could create additional downward pressure on the market price of our Common Stock and could cause our stock price to decline.trial;

56● clinical holds on, or other regulatory objections to, a new or ongoing clinical trial;

~~Risks~~● ~~Related~~delay or failure to ~~Estrella’s Operating~~manufacture ~~History~~sufficient quantities or inability to produce quantities of consistent quality, purity and ~~Financial~~potency ~~Condition~~of the product candidate for our clinical trials;

We● ~~are~~delay aor ~~clinical stage~~failure ~~biotechnology~~to ~~company~~reach ~~with~~agreement aon ~~history~~acceptable ofclinical ~~losses.~~trial Weagreement ~~expect~~terms toor ~~continue~~clinical totrial ~~incur~~protocols ~~significant~~with ~~losses~~prospective ~~for~~sites or CROs, the ~~foreseeable~~terms ~~future~~of which can be subject to extensive negotiation and may ~~never~~vary ~~achieve~~significantly oramong ~~maintain~~different ~~profitability.~~sites or CROs;

We● ~~are~~delay aor ~~clinical-stage~~failure ~~biotechnology company with a history of losses. Since our inception, we have devoted substantially all of our resources~~ to ~~preparing~~obtain ~~for~~institutional ~~the~~review ~~Business Combination,~~board ~~drafting regulatory filings~~ (~~including the INDs~~“IRB”), planning and conducting preclinical and clinical studies, and building our management team, and we have incurred significant operating losses. Our net losses were approximately $7.3 million and $11.1 million for the years ended June 30, 2024 and 2023, respectively. As of June 30, 2024, and June 30, 2023, we had an accumulated deficit of approximately $19.5 million and $12.2 million, respectively. Substantially all of our losses have resulted from expenses incurred in connection with preparing for the Business Combination, regulatory filings, and from general and administrative costs associated with our operations. To date, we have not generated any revenue from product sales, and we have not sought or ~~obtained~~ethics ~~regulatory~~committee approval ~~for any product candidate. Furthermore, we do not expect~~ to ~~generate~~conduct ~~any~~a revenue from product sales for the foreseeable future, and we expect to continue to incur significant operating losses for the foreseeable future due to the cost of research and development, preclinical studies, clinical ~~trials,~~ ~~and~~trial ~~the~~at ~~regulatory~~a ~~approval~~prospective ~~process for our current and potential future product candidates.~~site;

We● ~~expect~~the ~~our~~FDA ~~net~~or ~~losses~~other comparable foreign regulatory authorities may require us to ~~increase~~ ~~substantially~~submit asadditional ~~we:~~data or impose other requirements before permitting us to initiate a clinical trial;

● ~~commence~~slower ~~clinical~~than ~~trials~~expected rates of ~~EB103~~patient recruitment and enrollment;

● ~~continue~~failure ~~preclinical~~of ~~development~~patients ofto ~~EB104~~complete the clinical trial;

● ~~acquire~~the ~~and~~inability ~~license~~to ~~technologies,~~enroll ifa ~~any~~sufficient ~~are~~number ~~discovered,~~of ~~that~~patients ~~are~~in ~~aligned~~studies ~~with~~to ~~our~~ensure ~~product~~adequate ~~candidates~~statistical power to detect statistically significant treatment effects;

● ~~seek~~unforeseen ~~regulatory~~safety ~~approval~~issues, ofincluding ~~current~~severe ~~EB103~~or ~~and~~unexpected ~~EB104~~drug-related adverse effects experienced by patients, including possible deaths;

● ~~incur~~lack ~~expenses~~of ~~related~~efficacy or failure to measure a statistically significant clinical benefit within the ~~discovery~~dose ~~and~~range ~~development~~with ofan ~~any~~acceptable ~~potential~~safety ~~future~~margin ~~product~~during ~~candidates~~clinical trials;

● ~~expand~~termination of our ~~operational,~~clinical ~~financial,~~trials ~~and~~by ~~management~~one ~~systems~~or ~~and~~more ~~increase personnel, including personnel to support our preclinical and~~ clinical ~~development~~trial ~~and commercialization efforts~~sites;

● ~~continue~~inability toor ~~develop,~~unwillingness ~~perfect,~~of ~~and~~patients ~~defend~~or clinical investigators to follow our ~~intellectual~~clinical ~~property~~trial ~~portfolio~~protocols; ~~and~~

● ~~incur~~inability ~~additional~~to ~~legal,~~monitor ~~accounting,~~patients oradequately ~~other~~during ~~expenses~~or inafter ~~operating~~treatment ~~our~~by ~~business,~~us ~~including~~or ~~the~~our ~~additional costs associated with operating as a public company.~~CROs;

~~However,~~● ~~the amount of~~ our ~~future~~ ~~losses~~CROs ~~is uncertain. Our ability to achieve~~ or ~~sustain~~clinical ~~profitability,~~study ifsites ~~ever,~~failing ~~will~~to ~~depend~~comply ~~on,~~with ~~among other things, successfully developing product candidates, obtaining~~ regulatory ~~approvals~~requirements to market and commercialize product candidates, manufacturing any approved products on commercially reasonable terms, entering into potential future alliances, establishing a sales and marketing organization or ~~suitable~~ ~~third-party~~meet ~~alternatives~~their ~~for~~contractual ~~any~~obligations ~~approved product, and raising sufficient funds~~ to ~~finance~~us ~~business~~in ~~activities.~~a Iftimely wemanner, or ~~our potential~~at ~~future collaborators~~all, ~~are~~deviating ~~unable to commercialize one or more of our product candidates, or if sales revenue~~ from ~~any~~the ~~product candidate~~protocol ~~that receives approval is insufficient, we will not achieve~~ or ~~sustain~~dropping ~~profitability,~~out ~~which~~of ~~could have~~ a ~~material adverse effect on our business, financial condition, results of operations, and prospects.~~study;

57● inability to address any noncompliance with regulatory requirements or safety concerns that arise during the course of a clinical trial;

We● ~~will~~the need ~~substantial additional funds~~ to ~~advance development of product candidates~~suspend, ~~and~~repeat weor ~~cannot~~terminate ~~guarantee~~clinical ~~that~~trials weas ~~will~~a ~~have~~result ~~sufficient~~of ~~funds~~non-compliance ~~available~~with ~~in the~~regulatory ~~future~~requirements, toinconclusive ~~develop~~or ~~and~~negative ~~commercialize~~results ~~our current~~ or ~~potential~~unforeseen ~~future~~complications ~~product~~in ~~candidates~~testing; and ~~technologies.~~

~~The~~● ~~development~~the ofsuspension ~~biotechnology product~~or ~~candidates~~termination ~~is capital-intensive. If any~~ of our ~~current or potential future product candidates enter and advance through preclinical studies and~~ clinical trials, weupon ~~will~~a ~~need~~breach ~~substantial~~or ~~additional~~pursuant ~~funds~~ to ~~expand~~the ~~our~~terms ~~development,~~of ~~regulatory,~~any ~~manufacturing,~~agreement ~~marketing~~with, ~~and~~ ~~sales~~or ~~capabilities.~~for Weany ~~will~~other ~~require~~reason ~~significant~~by, ~~funds~~any tofuture ~~continue~~strategic tocollaborator ~~develop~~that ~~our~~has ~~product~~responsibility ~~candidates~~for ~~and~~the ~~conduct~~clinical ~~further research and~~ development, ~~including~~of ~~preclinical~~any ~~studies~~of ~~and~~our ~~clinical~~product ~~trials~~candidates. ~~In addition, we expect to incur significant additional costs associated with operating as a public company.~~

AsChanges ofin ~~June~~regulatory 30requirements, ~~2024 and June~~ 30policies, ~~2023,~~and weguidelines ~~had~~may ~~approximately~~also ~~$4.2~~occur ~~million~~ and ~~$2.5~~we ~~million,~~may ~~respectively,~~need into ~~cash~~significantly ~~and~~modify ~~cash~~our ~~equivalents.~~clinical ~~Our~~development ~~future~~plans ~~capital~~to ~~requirements~~reflect these changes ~~and~~with ~~the~~appropriate ~~period~~regulatory ~~for~~authorities. ~~which~~These ~~our~~changes ~~existing~~may ~~resources~~require ~~will~~us ~~support~~to ~~our~~renegotiate ~~operations~~terms ~~may~~with ~~vary~~CROs ~~significantly~~or ~~from~~resubmit ~~what~~clinical wetrial ~~expect.~~protocols to ~~Because~~IRBs ~~the~~for ~~length of~~re-examination, ~~time~~which ~~and~~may ~~activities~~impact ~~associated~~the ~~with~~costs, ~~successful~~timing, ~~research~~or ~~and~~successful ~~development~~completion of ~~platform~~a ~~technologies~~clinical ~~and~~trial. ~~product~~Our ~~candidates~~clinical istrials ~~highly uncertain,~~may webe ~~are~~suspended ~~unable~~or toterminated ~~estimate~~at ~~the~~any ~~actual~~time ~~funds~~by weus, ~~will~~the ~~require~~FDA, ~~for~~other ~~development~~regulatory ~~and~~authorities, ~~any~~the ~~approved~~IRB ~~marketing~~overseeing ~~and~~the ~~commercialization~~clinical ~~activities. The~~trial ~~timing~~at ~~and~~issue, ~~amount~~ any of our ~~operating~~clinical ~~expenditures~~trial ~~will~~sites ~~depend~~with ~~largely~~respect ~~on:~~to that site, or us.

~~● the timing and progress of preclinical and clinical development of our current and potential future product candidates;~~36

●Any ~~the~~failure ~~timing~~or ~~and~~significant delay ~~progress~~in ofcommencing or completing clinical trials for our ~~research~~product ofcandidates, ~~the~~any ~~use~~failure to obtain positive results from clinical trials, any safety concerns related to our product candidates, or any requirement to conduct additional clinical trials or other testing of ~~EB103~~our product incandidates ~~conjunction~~beyond ~~with~~those ~~CF33-CD19t;~~that we currently contemplate would adversely affect our ability to obtain regulatory approval and our commercial prospects and ability to generate product revenue will be diminished.

●If ~~the~~we ~~number~~decide ~~and~~to ~~scope~~seek oforphan ~~preclinical~~drug ~~and~~designation for ~~clinical~~one ~~programs~~or more of our product candidates, we ~~decide~~may be unsuccessful or may be unable to ~~pursue;~~maintain the benefits associated with orphan drug designation for our current or future product candidates that we may develop.

●Under the ~~terms~~Orphan Drug Act, the FDA may designate a product candidate as an orphan drug if it is a drug or biologic product intended to treat a rare disease or condition, which is generally defined as a patient population of ~~any~~fewer ~~third-party~~than ~~manufacturing~~200,000 ~~contract~~individuals annually in the United States, or ~~biomanufacturing~~where ~~partnership~~there is weno reasonable expectation that the cost of developing the product will be recovered from sales in the United States. We may ~~enter~~seek orphan ~~into;~~drug designation for certain indications for our product candidates in the future. Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process. Orphan drug designation can entitle a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.

●In ~~our~~addition, ~~ability~~if a product candidate with an orphan drug designation receives the first marketing approval for the indication for which it has such designation, the product is entitled to ~~maintain~~a period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for the same indication for seven years. The FDA may reduce the seven-year exclusivity if the same drug from a competitor demonstrates clinical superiority to the product with orphan exclusivity or if the FDA finds that the holder of the orphan exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan product to meet the needs of patients with the disease or condition for which the drug was designated. Even if one of our ~~current~~product ~~licenses~~candidates ~~and~~receives ~~collaborations~~orphan exclusivity, ~~conduct~~the ~~our~~FDA ~~research~~can ~~and~~still ~~development~~approve ~~programs~~other drugs ~~and~~that ~~establish~~have ~~new~~a ~~strategic~~different ~~partnerships~~active ~~and~~ingredient ~~collaborations;~~for use in treating the same indication or disease.

●In addition, exclusive marketing rights in the ~~progress~~United States may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the ~~development~~product ~~efforts~~to meet the needs of ~~our~~patients ~~existing~~with ~~strategic~~the ~~partners~~rare ~~and~~disease ~~third~~or condition. ~~parties~~Further, even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with ~~whom~~different active moieties can be approved for the same condition, and while we may seek orphan drug designation for our product candidates, we may never receive such designations. In addition, the FDA may reevaluate the Orphan Drug Act and its regulations and policies. We do not know if, when, or how the FDA may change the orphan drug regulations and policies in the future, ~~enter~~and ~~into~~it ~~collaboration~~is ~~and~~uncertain ~~research~~how any changes might affect our business. Depending on what changes the FDA may make to its orphan drug regulations and ~~development~~policies, ~~agreements;~~our business could be adversely impacted.

●We ~~the~~may ~~costs~~not ~~involved~~be inable ~~obtaining~~to conduct, ~~maintaining~~or contract with others to conduct, ~~enforcing~~animal testing in the future, ~~and~~which ~~defending~~could ~~patents~~harm ~~and~~our ~~other~~research ~~intellectual~~and ~~property~~development ~~rights;~~activities.

●Certain laws and regulations relating to drug development require us to test our product candidates on animals before initiating clinical trials involving humans. Animal testing activities have been the ~~impact~~subject of controversy and adverse publicity. Animal rights groups and other organizations and individuals have attempted to stop animal testing activities by pressing for legislation and regulation in these areas and by disrupting these activities through protests and other means. To the ~~COVID-19~~extent ~~pandemic~~the onactivities of these groups are successful, our ~~business;~~research and development activities may be interrupted or delayed.

●Risks ~~the~~Related ~~cost~~to ~~and~~Third ~~timing of regulatory approvals; and~~Parties

●We ~~our~~rely ~~efforts~~on third parties to ~~enhance~~conduct ~~operational~~our preclinical ~~systems~~studies and ~~hire~~our ~~additional~~clinical ~~personnel~~trial for EB103, ~~including~~and ~~personnel~~plan to ~~support~~rely ~~development~~on ofthird parties to conduct any clinical trials for our ~~product~~other product candidates, and ~~satisfy~~those ~~our~~third ~~obligations~~parties asmay anot ~~public~~perform ~~company~~satisfactorily.

ToWe ~~date,~~expect weto ~~have~~rely ~~primarily~~on third-party ~~financed~~clinical ~~our~~investigators, ~~operations~~CROs, ~~through~~clinical ~~the~~data ~~sale~~management oforganizations, ~~equity~~and ~~securities.~~consultants Weto ~~may~~design, ~~seek~~conduct, tosupervise, ~~raise~~and ~~any~~monitor ~~necessary~~certain preclinical ~~additional~~studies ~~capital~~and ~~through~~any aclinical ~~combination of~~trials. ~~public~~Because orwe ~~private~~intend ~~equity~~to ~~offerings,~~rely ~~debt~~on ~~financings,~~these ~~collaborations,~~third ~~strategic~~parties ~~alliances,~~and ~~licensing~~will ~~arrangements,~~not ~~grants,~~have ~~and~~the ~~other marketing~~ability ~~and~~to ~~distribution~~conduct certain ~~arrangements.~~preclinical Westudies ~~cannot~~or ~~assure~~clinical ~~you~~trials ~~that~~independently, we will behave ~~successful~~less incontrol ~~acquiring~~over ~~additional~~the ~~funding~~timing, atquality, ~~levels~~and ~~sufficient~~other aspects of tosuch ~~fund~~preclinical ~~our~~studies ~~operations~~and orclinical ontrials ~~terms~~than ~~favorable~~we towould ~~us.~~have Ifhad we ~~are~~conducted ~~unable~~them toon ~~obtain~~our ~~adequate~~own. ~~financing~~These ~~when~~investigators, ~~needed~~CROs, weclinical data ~~may~~management ~~have to delay~~organizations, ~~reduce the~~and ~~scope~~consultants ofwill ornot ~~suspend~~be ~~one~~our oremployees ~~more~~and ofwe ~~our~~will ~~preclinical~~have ~~studies,~~limited ~~clinical~~control ~~trials,~~over ~~research~~the ~~and~~amount ~~development~~of ~~programs~~time ~~or commercialization~~and ~~efforts.~~resources ~~Because~~that ofthey ~~the~~dedicate ~~numerous~~to ~~risks~~our ~~and~~programs. ~~uncertainties~~Some ~~associated~~of ~~with~~these ~~the~~third ~~development~~parties ~~and~~may ~~commercialization~~terminate oftheir ~~our~~engagements ~~current~~with ~~and~~us ~~potential future~~at ~~product~~any ~~candidates~~time. ~~and~~We ~~the~~also expect ~~extent~~ to ~~which~~have weto ~~may~~negotiate ~~enter~~budgets ~~into~~and ~~collaborations~~contracts with ~~third~~CROs, ~~parties~~clinical totrial ~~participate~~sites inand ~~their~~contract ~~development and~~manufacturing ~~commercialization,~~organizations and we ~~are~~may not ~~unable~~be able to ~~estimate~~do ~~the~~so ~~amounts~~on offavorable ~~increased~~terms, ~~capital~~which ~~outlays~~may ~~and~~result ~~operating~~in ~~expenditures~~delays ~~associated~~to ~~with~~ our ~~current~~ ~~and~~development ~~anticipated~~timelines ~~preclinical studies~~ and ~~clinical~~increased ~~trials, including related manufacturing~~ costs. ToIf ~~the extent that~~ we ~~raise~~need ~~additional~~to enter ~~capital~~into ~~through~~alternative ~~collaborations,~~arrangements ~~strategic alliances~~with, or ~~licensing~~replace ~~arrangements~~or ~~with~~add any third parties, weit ~~may~~would ~~have~~involve tosubstantial ~~relinquish~~cost ~~valuable rights~~and torequire ~~our~~extensive ~~current~~management time and ~~potential~~focus, ~~future~~or ~~product~~involve ~~candidates,~~a ~~future~~transition ~~revenue~~period, ~~streams~~and ormay ~~research~~delay ~~programs~~our ordrug ~~grant~~development ~~licenses~~activities, onas ~~terms that~~well ~~may~~as ~~not~~materially beimpact ~~favorable~~our ability to ~~us.~~meet Ifour wedesired doclinical ~~raise~~development ~~additional~~timelines. ~~capital~~These ~~through~~third ~~public~~parties ormay ~~private~~have ~~equity~~contractual orrelationships ~~convertible~~with ~~debt~~other ~~offerings~~entities, ~~the ownership~~some ~~interest~~ of which ~~our~~may ~~existing stockholders will~~ be ~~diluted~~our competitors, ~~and~~which ~~the terms of these securities~~ may ~~include~~draw ~~liquidation~~time orand ~~other~~resources ~~preferences that~~from ~~adversely affect~~ our ~~stockholders’ rights~~programs. IfThe wethird ~~raise~~parties ~~additional~~with ~~capital~~which ~~through debt financing,~~ we may becontract ~~subject~~might not tobe ~~covenants limiting~~diligent, careful, or ~~restricting~~timely in conducting our ~~ability~~preclinical tostudies ~~take~~or ~~specific~~clinical ~~actions~~trials, ~~such~~resulting asin ~~incurring~~the ~~additional~~preclinical ~~debt,~~studies ~~making~~or clinical ~~capital~~trials ~~expenditures,~~being delayed or ~~declaring dividends~~unsuccessful.

5837

WeOur doreliance on these third parties for such drug development activities will reduce our control over these activities. As a result, we will have less direct control over the conduct, timing, and completion of preclinical studies and clinical trials and the management of data developed through preclinical studies and clinical trials than would be the case if we were relying entirely upon our own staff. Nevertheless, we will be responsible for ensuring that each of our studies and trials is conducted in accordance with applicable protocol, legal, and regulatory requirements and scientific standards, including good laboratory practice (“GLP”), good clinical practice (“GCP”), Current Good Manufacturing Practice (“cGMP”), and Current Good Tissue Practice (“cGTP”), and our reliance on third parties does not ~~expect~~relieve tous ~~realize~~of our regulatory responsibilities. For example, we will ~~revenue~~remain ~~from~~responsible ~~product~~for ~~sales~~ensuring orthat ~~royalties~~each ~~from~~of ~~licensed~~our ~~products~~clinical trials is conducted in accordance with the general investigational plan and protocols for the ~~foreseeable~~trial. ~~future~~Moreover, ifthe atFDA ~~all~~and other regulatory authorities require us to comply with GCP standards, regulations for conducting, recording, and ~~unless~~reporting the results of clinical trials to assure that data and ~~until~~reported results are reliable and accurate and that the rights, integrity, and confidentiality of trial participants are protected. Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, principal investigators, and trial sites. If we or any of our CROs, ~~current~~clinical sites and investigators fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and ~~potential~~the ~~future~~FDA, European Medicines Agency (“EMA”), or other regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. There can be no assurance that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials substantially comply with GCP regulations. In addition, our clinical trials must be conducted with product candidates ~~are~~produced ~~clinically~~under ~~tested~~cGMP regulations and will require a large number of test patients. Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients, ~~approved~~may ~~for~~require ~~commercialization~~us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violates FDA regulatory requirements as well as federal or state healthcare laws and ~~successfully~~regulations ~~marketed~~or healthcare privacy and security laws.

~~Members~~If ofthese ~~our~~third ~~management~~parties do not ~~team~~successfully ~~have~~carry ~~limited~~out ~~experience~~their contractual duties, meet expected deadlines or conduct our clinical trials in ~~managing~~accordance ~~the~~with ~~day-~~regulatory requirements or our stated protocols, or if these third parties need to~~-day~~ ~~operations~~be ofreplaced, awe ~~public~~will ~~company~~not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates and will not be able to, asor may be delayed in our efforts to, successfully commercialize our product candidates. As a result, weour ~~may~~financial ~~incur~~results ~~additional~~and ~~expenses~~the commercial prospects for our product candidates would ~~associated~~be ~~with~~harmed, ~~the~~our ~~management~~costs ofcould increase and our ~~company~~ability to generate revenue could be delayed.

~~Members~~We ofdepend ~~our~~on ~~management team~~strategic ~~have~~partnerships, ~~limited~~such ~~experience~~as ~~in managing~~ the ~~day-to-day~~Licensing ~~operations~~Agreement ofwith aEureka ~~public~~and ~~company. As a result, we~~ may ~~need~~in tothe ~~obtain~~future ~~outside assistance~~depend ~~from~~on ~~legal~~collaborations, ~~accounting,~~such ~~investor~~as ~~relations,~~our orprior ~~other~~Collaboration ~~professionals~~Agreement ~~that could be more costly than planned. We may also hire additional personnel to comply~~ with ~~additional~~Imugene, ~~SEC~~for ~~reporting~~the ~~requirements.~~development ~~These~~and ~~compliance~~commercialization ~~costs~~of ~~will~~EB103, ~~make some activities significantly more time-consuming~~EB104, and ~~costly.~~future Ifproduct wecandidates ~~lack~~in ~~cash~~certain ~~resources~~indications, toand ~~cover~~if these ~~costs~~arrangements inare ~~the future~~unsuccessful, ~~our~~this ~~failure to comply with reporting requirements and other provisions of securities laws~~ could ~~negatively~~impair ~~affect~~ our ~~stock~~ability ~~price~~to generate revenues and ~~adversely~~materially ~~affect~~harm our ~~potential~~ results of operations~~, cash flow and financial condition~~.

Our ~~financial~~business ~~statements expressing~~strategy ~~substantial~~for ~~doubt~~the ~~about~~research ~~our~~of ~~ability~~EB103’s touse ~~continue~~in asconjunction awith ~~going~~CF33-CD19t ~~concern~~was ~~due~~previously todependent upon maintaining our ~~history~~arrangement ofwith ~~recurring~~Imugene ~~losses~~under ~~and~~the ~~our~~Collaboration ~~expectation that~~Agreement, ~~negative~~which ~~cash~~concluded ~~flows~~its ~~from~~research ~~operations~~plan ~~will~~on ~~continue~~August ~~until~~30, we2023. Our ~~can~~ongoing ~~generate~~strategy ~~sufficient~~relies ~~revenue.~~on ~~Our~~arrangements ~~ability~~with tostrategic ~~continue~~partners, research collaborators, and others, such as athe ~~going~~Licensing ~~concern~~Agreement ~~requires~~with ~~that~~Eureka, wewhich ~~obtain~~grants ~~sufficient~~us ~~funding~~an exclusive license to ~~finance~~use ~~our~~ARTEMIS® ~~operations~~technology in connection with CD19 and CD22 in the Licensed Territory. These agreements provide for, among other things, intellectual property rights and significant future payments should certain development, regulatory, and commercial milestones be achieved.

WeAs ~~have~~a ~~incurred significant operating losses to date~~result, ~~and it is possible~~ we may ~~never~~not ~~generate~~be aable ~~profit.~~to ~~Our~~conduct ~~consolidated~~these ~~financial~~collaborations ~~statements included elsewhere~~ in ~~this~~the ~~Annual~~manner ~~Report~~or ~~have been prepared~~ on ~~a going concern basis, which contemplates~~ the ~~realization~~time ofschedule ~~assets~~we ~~and satisfaction of liabilities~~previously incontemplated, ~~the~~which ~~ordinary~~may ~~course~~negatively ofimpact business. These consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of these uncertainties related to our ~~ability~~business ~~to operate on a going concern basis~~operations.

We have concluded that our recurring losses from operations and need for additional financing to fund future operations raise substantial doubt about our ability to continue as a going concern. SimilarlyAdditionally, our independent registered public accounting firm has included an explanatory paragraph in its report on our financial statements expressing substantial doubt about our ability to continue as a going concern. We believe that the ~~financing~~development ~~proceeds raised at Closing will eliminate this doubt~~ and ~~enable~~commercialization usof topotential ~~continue~~product ascandidates aunder ~~going concern; however, we may need to obtain alternative financing or significantly modify~~ our ~~operational~~collaboration ~~plans for us to continue as a going concern. Based upon our current~~agreements ~~operating~~could ~~plan~~be ~~and~~substantially ~~assumptions~~delayed, ~~we believe that our existing cash~~ and ~~cash equivalents will be sufficient to fund~~ our ~~operations~~ability ~~for at least the next 12 months. This estimate is based on assumptions that may prove~~ to bereceive ~~wrong,~~future ~~and~~funding we could ~~use~~be ~~our~~substantially ~~available~~impaired ~~capital~~if ~~resources sooner~~one ~~than~~or wemore ~~expect. Changes may occur beyond our control that would cause us to consume our available capital before that time, including changes in and progress~~ of our ~~development activities and changes in regulation. Our future capital requirements will depend on many factors, including~~collaborators:

● ~~the~~shifts ~~scope,~~its ~~rate~~priorities ofand ~~progress,~~resources ~~results,~~away ~~and~~from ~~costs~~our ofcollaborations ~~preclinical~~due ~~studies~~to a change in business strategies, ~~laboratory~~or ~~testing~~a merger, ~~and~~acquisition, ~~clinical~~sale, ~~trials~~or ~~for~~downsizing ~~our~~of ~~product~~its ~~candidates~~company or business unit;

59● ceases development in therapeutic areas which are the subject of our collaboration;

~~● the number and development requirements of product candidates that we may pursue, and other indications for our current product candidates that we may pursue;~~38

● ~~the~~fails ~~costs~~to select a product candidate for advancement into preclinical development, ~~timing~~clinical ~~and~~development, ~~outcome~~or ofsubsequent ~~regulatory~~clinical ~~review~~development ofinto ~~our~~a ~~product~~marketed ~~candidates~~product;

● changes the ~~scope~~success ~~and~~criteria ~~costs~~for a particular product candidate, thereby delaying or ceasing development of ~~manufacturing~~such ~~arrangements~~product candidate;

● significantly delays the ~~cost~~initiation ~~associated~~or ~~with~~conduct ~~commercializing~~of ~~any~~certain ~~approved~~activities ~~product~~which ~~candidates~~could delay our receipt of milestone payments tied to such activities, thereby impacting our ability to fund our own activities;

● ~~the~~develops ~~cost~~a ~~and~~product ~~timing~~candidate ofthat ~~developing~~competes, ~~our~~either ~~ability~~directly toor ~~establish~~indirectly, ~~sales~~with ~~and~~our ~~marketing~~product ~~capabilities, if any~~candidates;

● ~~the~~does ~~costs~~not ofobtain ~~preparing,~~the ~~filing~~requisite ~~and~~regulatory ~~prosecuting~~approval ~~patent~~of ~~applications,~~a ~~maintaining,~~product ~~enforcing, and protecting our intellectual property rights, defending intellectual property-related claims, and obtaining licenses to third-party intellectual property~~candidate;

● ~~the~~does ~~timing~~not ~~and~~successfully ~~amount~~commercialize ofa ~~any~~product ~~milestone and royalty payments we are required to make under our present or future license agreements~~candidate;

● ~~our~~encounters ~~ability to establish and maintain strategic partnerships and collaborations~~regulatory, ~~including~~resource ~~any biomanufacturing partnerships~~ or ~~collaborations~~quality ~~involving~~issues ~~the~~and ~~use~~is ofunable ~~our~~to ~~products,~~meet ondemand ~~favorable terms, if at all~~requirements; ~~and~~

● exercises its rights under the ~~extent~~agreement to ~~which~~terminate wethe ~~acquire~~collaboration, or ~~in-license~~otherwise ~~other~~withdraws ~~product~~support ~~candidates~~for, ~~and~~or ~~technologies~~otherwise ~~and~~impairs ~~associated~~development ~~intellectual~~under ~~property.~~the collaboration;

We● ~~will~~disagrees ~~require~~on ~~additional capital~~the toresearch, ~~complete our planned clinical~~ development ~~programs~~or ~~for~~commercialization ~~our~~of ~~current~~a product ~~candidates~~candidate toresulting ~~obtain~~in ~~regulatory~~a ~~approvals.~~delay ~~Any~~in ~~additional capital~~milestones, ~~raising~~royalty ~~efforts may divert our management from their day-to-day activities~~payments, ~~which~~or ~~may~~termination ~~adversely~~of ~~affect~~research ~~our ability to develop~~ and ~~commercialize~~development ~~our~~activities ~~current~~for ~~and~~such ~~future~~ product ~~candidates,~~candidate; ~~if approved.~~and

In● ~~addition,~~uses we cannot guarantee that future financing will be available on a timely basis, in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our ~~stockholders~~proprietary ~~and~~information ~~the issuance of additional securities by us, whether equity~~ or ~~debt,~~intellectual orproperty ~~the~~in ~~market perception that~~ such issuances are likely to occur, could cause the market price of Common Stock to decline. If we are unable to raise sufficient capital when needed, our business, financial condition and results of operations will be harmed, and we will need to significantly modify our operational plans to continue as a ~~going~~way ~~concern. If we are unable to continue~~ as ~~a going concern, we might have~~ to ~~liquidate~~jeopardize our ~~assets~~rights ~~and the values we receive for our assets~~ in ~~liquidation~~such ~~or dissolution could be significantly lower than the values reflected in our consolidated financial statements~~property. ~~We were required to make significant payments to Eureka in connection with the Closing of the Business Combination, which could adversely affect our liquidity and financial condition.~~

~~Under~~In addition, the ~~terms~~ termination of our ~~agreements with~~existing ~~Eureka,~~collaborations ~~following~~or ~~closing~~any offuture ~~the~~strategic ~~Business~~partnership ~~Combination,~~or ~~significant~~collaboration ~~payments~~arrangement tothat ~~Eureka~~we ~~became~~enter ~~due~~into ~~and~~may ~~payable~~prevent ~~under~~us ~~our agreements~~from ~~with~~receiving ~~Eureka.~~any ~~Accordingly~~milestone, onroyalty ~~October 9~~payment, ~~2023,~~sharing ~~we used a portion~~ of ~~the~~profits, ~~$19.6~~and ~~million~~other ~~net~~benefits ~~proceeds from the Business Combination to pay approximately $8.3 million due to Eureka~~ under ~~the~~such ~~Services Agreement and approximately $0~~agreement.9 ~~million~~Furthermore, ~~aggregate~~disagreements ~~amount due to Eureka under~~with ~~the~~these ~~License~~parties ~~Agreement,~~could ~~comprised~~require ofor ~~the~~result ~~remainder~~in oflitigation ~~the~~or ~~upfront~~arbitration, ~~fee~~which aswould ~~well~~be astime-consuming aand ~~milestone~~expensive. ~~payment~~Any inof ~~connection~~these ~~with~~events ~~the submission~~could ofhave ~~the~~a ~~IND~~material ~~application~~adverse ~~for~~effect ~~EB103,~~on ~~which reduced~~ our ~~available~~ability ~~capital~~to ~~resources.~~develop ~~Furthermore,~~and ascommercialize ~~the~~any ~~majority shareholder~~ of ~~Estrella, Eureka may have significant control over~~ our ~~management~~product candidates and ~~operations,~~may ~~which~~adversely ~~could~~impact ~~affect~~ our business, ~~ability~~prospects, tofinancial ~~negotiate~~condition, orand ~~modify~~results ~~future~~of ~~payment terms in our favor~~operations.

60We may not realize the anticipated benefits of our prior collaboration agreement with Imugene.

~~Risks~~Our ~~Related~~prior tocollaboration with Imugene, which concluded its research plan on August 30, 2023, explored the ~~Development~~therapeutic ~~and~~potential ~~Clinical~~of ~~Testing~~a combination of ~~Our~~Imugene’s ~~Product~~CF33-CD19t ~~Candidates~~in conjunction with EB103 for the treatment of solid tumors. However, Imugene could develop therapies outside of our collaboration that do not utilize EB103. For example, Imugene could develop an oncolytic virus that forces tumors to express a protein other than CD19 for a “mark and kill” approach to treating solid tumors, which would require a combination with a T-cell therapy other than EB103.

~~Our~~We ~~current~~may ~~product candidates~~not ~~are~~be inable ~~either~~to ~~preclinical~~enter orinto ~~clinical~~additional strategic ~~development.~~transactions ~~One~~on oracceptable terms, if at all, ofwhich could adversely affect our ability to develop and commercialize current and potential future product candidates ~~may~~and ~~fail~~technologies, inimpact ~~clinical~~our ~~development or~~cash ~~suffer~~position, ~~delays~~increase ~~that~~our ~~materially~~expenses and ~~adversely~~present ~~affect~~significant ~~their~~distractions to ~~commercial~~our ~~viability~~management.

WeFrom ~~have~~time noto ~~products~~time, onwe ~~the~~consider ~~market~~strategic transactions, such as collaborations, geographic partnerships for the co-development and/or ~~that~~co-commercialization ~~have~~of ~~gained~~our ~~regulatory~~product candidates ~~approval~~in selected territories, acquisitions of companies, asset purchases, joint ventures, out-or ~~that~~in-licensing ~~have~~of ~~entered~~product ~~clinical~~candidates or ~~trials~~technologies and biomanufacturing partnerships. ~~Our~~For ~~ability~~example, towe ~~achieve~~will evaluate and, ~~sustain~~if ~~profitability~~strategically attractive, seek to enter into ~~depends~~collaborations, onincluding ~~obtaining~~with ~~regulatory~~biotechnology ~~approvals~~or biopharmaceutical companies, contract development manufacturing organizations, or hospitals. The competition for collaborators is intense, and ~~successfully~~the ~~commercializing~~negotiation ~~product~~process ~~candidates~~is time-consuming and complex. If we are not able to enter into strategic transactions, ~~either~~we ~~with~~may ~~Eureka~~not ~~pursuant~~have access to ~~the~~required liquidity or expertise to further develop our current or potential future product ~~Services~~candidates. ~~Agreement~~Any such collaboration, or ~~with~~other strategic transaction, may require us to incur non-recurring or other ~~collaborators~~charges, increase our near-and long-term expenditures and pose significant integration or implementation challenges or disrupt our management or business.

Before obtaining regulatory approval for the commercial distribution of our product candidates, we or a collaborator must conduct extensive preclinical studies, followed by clinical trials to demonstrate the safety, purity and potency, or efficacy of our product candidates in humans. There is no guarantee that the U.S. Food and Drug Administration (the “FDA”) will permit us to conduct clinical trials. Further, we cannot be certain of the timely completion or outcome of our preclinical studies and cannot predict if the FDA or other regulatory authorities will accept our proposed clinical programs, our clinical protocols or if the outcome of our preclinical studies will ultimately support the further development of our preclinical programs or testing in humans. As a result, we cannot be sure that we will be able to submit investigational new drug applications (“INDs”) or similar applications for our proposed clinical programs on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing clinical trials for any of our product candidates to begin.39

~~Our~~We ~~current~~also ~~product~~may ~~candidates~~acquire additional ~~are~~technologies ~~in either preclinical or clinical development~~ and weassets, ~~are~~form ~~subject~~strategic toalliances, ~~the~~or ~~risks~~create ofjoint ~~failure~~ventures ~~inherent~~with inthird ~~the~~parties ~~development~~that ~~of product candidates based on novel approaches, targets, and mechanisms of action. Although~~ we ~~have~~believe ~~initiated~~will acomplement ~~clinical~~or ~~trial for EB103 and anticipate initiating~~augment ~~clinical trials for~~ our ~~other~~existing ~~product candidates~~business, ~~there~~but ~~is no guarantee that~~ we ~~will~~may not be able to ~~proceed~~realize ~~with~~the ~~clinical~~benefit ~~development~~ of ~~any of~~acquiring ~~these~~such ~~product~~assets. ~~candidates~~Conversely, ~~or that~~ any ~~product~~new ~~candidate~~collaboration ~~will~~that we ~~demonstrate~~do aenter ~~clinical~~into ~~benefit~~may ~~once~~be weon ~~advance~~terms ~~these~~that ~~candidates~~are tonot ~~testing in~~optimal ~~patients.~~for ~~Accordingly~~us, ~~you should consider~~ our ~~prospects~~product ~~in light of the costs~~candidates, ~~uncertainties,~~or ~~delays~~our ~~and~~technologies. ~~difficulties~~These ~~frequently~~transactions ~~encountered~~would entail bynumerous ~~clinical~~operational ~~stage~~and ~~biotechnology~~financial ~~companies~~risks, ~~such as ours.~~including:

We● ~~may~~exposure ~~not be able~~ to ~~access the~~unknown financial resources to continue development of, or to enter into any collaborations for, any of our current or potential future product candidates. This may be exacerbated if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, a product candidate, such as:liabilities;

● ~~negative~~disruption orof ~~inconclusive results from~~ our ~~preclinical~~business ~~studies~~and ordiversion ~~clinical~~of ~~trials~~our ormanagement’s ~~the~~time ~~clinical~~and ~~trials~~attention ofin ~~others~~order ~~for product candidates similar~~ to ~~ours,~~negotiate ~~leading~~and tomanage a ~~decision~~collaboration or ~~requirement~~develop toacquired ~~conduct~~products, ~~additional~~product ~~preclinical~~candidates, ~~studies~~ or ~~clinical trials or abandon any or all of our programs~~technologies;

● ~~product-related~~incurrence ~~side~~of ~~effects~~substantial ~~experienced~~debt ~~by participants in our clinical trials~~ or bydilutive ~~individuals~~issuances ~~using~~of ~~therapeutics~~equity ~~similar~~securities to ~~our~~pay ~~product~~transaction ~~candidates~~consideration or costs;

● ~~delays in submitting INDs (other~~ higher-than-expected ~~the IND for EB103~~collaboration, ~~which~~acquisition ~~was~~or ~~cleared~~integration ~~by the FDA on March 2~~costs, ~~2023)~~write-downs orof ~~comparable~~assets ~~foreign applications,~~ or ~~delays~~goodwill or ~~failures~~impairment ~~to obtain the necessary approvals from regulatory authorities to commence a clinical trial~~charges, or aincreased ~~suspension~~amortization ~~or termination of a clinical trial once commenced~~expenses;

● ~~conditions~~difficulty ~~imposed~~and bycost in facilitating the ~~FDA~~collaboration or ~~other~~combining ~~regulatory authorities regarding~~ the ~~scope~~operations orand ~~design~~personnel of ~~our~~any ~~clinical~~acquired ~~trials~~business;

● ~~delays~~impairment inof ~~enrolling~~relationships ~~research~~with ~~subjects~~key suppliers, manufacturers, or customers of any acquired business due to changes in ~~clinical~~management ~~trials~~and ownership; and

● ~~high~~the ~~drop-out~~inability ~~rates~~to retain key employees of ~~research~~any ~~subjects;~~acquired business.

61Accordingly, although there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, any transactions that we do complete may be subject to the foregoing or other risks and our business could be materially harmed by such transactions. Conversely, any failure to enter any collaboration or other strategic transaction that would be beneficial to us could delay the development and potential commercialization of our product candidates and technologies and have a negative impact on the competitiveness of any product candidate or technology that reaches market.

●In ~~inadequate~~addition, ~~supply~~to orthe ~~quality~~extent that ofany future collaborators terminate a collaboration agreement, we may be forced to independently develop our current and future product candidates ~~candidate~~and ~~components~~technologies, including funding preclinical studies or ~~materials~~clinical trials, assuming marketing and distribution costs and maintaining, enforcing and defending intellectual property rights, or, ~~other~~in ~~supplies~~certain ~~necessary~~instances, ~~for~~abandon ~~the~~product ~~conduct~~candidates and technologies altogether, any of which could result in a change to our ~~clinical~~business ~~trials;~~plan and have a material adverse effect on our business, financial condition, results of operations and prospects.

●The ~~chemistry,~~ manufacturing, ~~and~~of ~~control~~our ~~(“CMC”)~~product ~~challenges~~candidates is ~~associated~~complex. ~~with~~We ~~the~~may ~~manufacturing~~encounter difficulties in production, and ~~scaling~~because upwe ~~product~~currently ~~candidates~~rely toon ~~ensure~~Eureka ~~consistent~~as ~~quality,~~our ~~stability,~~sole ~~purity~~supplier of clinical drug product, ~~and~~any ~~potency~~such ~~among~~difficulties ~~different~~or ~~batches~~any ~~used~~disruption in our relationship with Eureka could delay or halt our clinical ~~trials;~~programs and, if approved, commercial supply.

●The ~~greater~~manufacture of biopharmaceutical products is complex and requires significant expertise, including the development of advanced manufacturing techniques and process controls. The process of manufacturing our product candidates is also extremely susceptible to product loss due to contamination, equipment failure or improper installation or operation of equipment, operator error, inconsistency in yields, variability in product characteristics and difficulties in scaling the production process. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If microbial, viral or other contaminations are discovered in our product candidates or the manufacturing facilities in which they are made, the facilities may need to be closed for an extended period of time to investigate and remedy the contamination. As a result of these complexities, the cost to manufacture biologics in general, and our cell-based product candidates in particular, is generally higher than~~-anticipated~~ ~~clinical~~traditional ~~trial~~small ~~costs;~~molecule chemical compounds, and the manufacturing process is less reliable and is more difficult to reproduce.

~~● poor effectiveness of our product candidates during clinical trials;~~40

●We ~~unfavorable~~currently ~~FDA~~do not own or operate any manufacturing facilities and have limited personnel with manufacturing experience. We rely entirely on Eureka Therapeutics, Inc., our parent and controlling stockholder, to manufacture EB103 and our other ~~regulatory~~ARTEMIS® ~~authority~~T-cell product ~~inspection~~candidates for our preclinical studies and ~~review~~clinical trials under our license and services arrangements, and Eureka is currently our sole supplier of clinical drug product. Eureka manufactures our product candidates at a ~~clinical~~limited ~~trial~~number of facilities. If Eureka experiences any manufacturing, quality, safety, regulatory or other operational problems, if it fails to perform its obligations in accordance with applicable specifications, cGMP requirements or other regulatory requirements, if it is unable or unwilling to supply us with sufficient quantities of our product candidates on a timely basis and at acceptable costs, or if our arrangements with Eureka are terminated or materially disrupted, we would not have an immediately available alternative source of supply. Identifying, qualifying and transferring our manufacturing ~~site;~~processes to one or more replacement manufacturers would be time-consuming and costly, would require additional regulatory filings and approvals, and could involve unforeseen technical challenges. Any such transition could result in substantial delays in our ongoing or planned clinical trials, increased development and manufacturing costs, and, if our product candidates are approved, interruptions or delays in commercial supply.

●Any ~~delays~~adverse asdevelopments aaffecting manufacturing operations for our product candidates, whether at Eureka or any future third-party manufacturer, may result ofin shipment delays, inventory shortages, lot failures, product withdrawals or recalls, or other interruptions in the ~~COVID~~supply of our products. We may also have to take inventory write-19offs ~~pandemic~~and incur other charges and expenses for products that fail to meet specifications, undertake costly remediation efforts, or ~~events~~seek ~~associated~~more ~~with~~costly ~~the~~manufacturing ~~pandemic;~~alternatives. Furthermore, it is too early to estimate our cost of goods sold. The actual cost to manufacture our product candidates could be greater than we expect because we are early in our development efforts.

●Changes ~~failure~~in methods of ~~Eureka~~product orcandidate manufacturing ~~our third-party contractors~~ or ~~investigators~~formulation tomay ~~comply~~result ~~with~~in ~~regulatory~~the ~~requirements~~need orto ~~otherwise~~perform ~~meet~~new ~~their~~clinical ~~contractual~~trials, ~~obligations~~which inwould arequire ~~timely~~additional ~~manner,~~costs orand atcause ~~all;~~delay.

●As ~~delays~~product candidates are developed through preclinical to late-stage clinical trials towards approval and ~~changes~~commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in ~~regulatory~~an ~~requirements~~effort to optimize yield and manufacturing batch size, ~~policies~~minimize costs and ~~guidelines;~~achieve consistent quality and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause our product candidates to perform differently and affect the results of ongoing, planned, or future clinical trials conducted with the altered materials. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and jeopardize our ability to commence product sales and generate revenue.

●Risks ~~the~~Related ~~FDA~~to orOur ~~other~~Business ~~regulatory~~and ~~authorities interpreting our data differently than we do.~~Operations

~~Further,~~If ~~we,~~the ~~Eureka, and any existing or potential future collaborator may never receive approval to~~ market ~~and~~opportunities ~~commercialize~~for ~~any~~our ~~product candidate. Even if we, Eureka,~~current orand ~~any existing or~~ potential future ~~collaborator~~product ~~obtains regulatory approval~~candidates, ~~the approval may be for targets, disease indications or patient populations that~~ are ~~not~~smaller asthan ~~broad as~~ we ~~intended~~believe orthey ~~desired or may require labeling that includes significant use or distribution restrictions or safety warnings. We~~are, ~~Eureka,~~our ~~or an existing or potential~~ future ~~collaborator~~product revenues may ~~also~~ be ~~subject~~adversely ~~to post-marketing testing~~affected, ~~requirements~~and toour ~~maintain~~business ~~regulatory~~may ~~approval~~suffer.

WeOur ~~may~~understanding ~~not~~of the number of people who suffer from diseases that our current product candidates may be ~~successful~~able to treat are based on estimates. These estimates may prove to be incorrect, and new studies may reduce the estimated incidence or prevalence of these diseases. The number of patients in the United States or elsewhere may turn out to be lower than expected, may not be otherwise amenable to treatment with our ~~efforts~~current or potential future product candidates or patients may become increasingly difficult to ~~use~~identify and ~~expand~~access, all of which would adversely affect our ~~use~~business ofprospects and financial condition. In particular, the ~~ARTEMIS®~~treatable ~~platform~~population tofor ~~expand~~our candidates may further be reduced if our ~~pipeline~~estimates of addressable populations are erroneous or sub-populations of patients do not derive benefit from our product candidates.

AFurther, ~~key~~there ~~element~~are ~~of our strategy~~several isfactors tothat ~~use~~could ~~and~~contribute ~~advance our use of the ARTEMIS® platform~~ to ~~design,~~making ~~test, and build our portfolio of product candidates focused on~~ the ~~treatment~~ ofactual ~~cancer.~~number ~~Our and Eureka’s research and development efforts to date have resulted in our discovery and preclinical development~~ of ~~EB103~~patients ~~and~~who ~~other~~receive ~~potential product candidates. We received IND clearance from the FDA for EB103 on March 2, 2023, and dosed~~ our ~~first patient~~current ~~in the STARLIGHT-1 clinical trial (NCT06343311) for EB103 in July 2024. However, we cannot assure you that EB103~~ or ~~any~~potential ~~of our other existing or~~ future product candidates ~~will successfully complete clinical trials or demonstrate these product candidates to be safe~~less orthan ~~effective~~the ~~therapeutics,~~potentially ~~and~~addressable ~~we may not be able to successfully develop any product candidates~~market. ~~Even~~These ifinclude wethe ~~are~~lack ~~successful~~of inwidespread ~~expanding our~~availability ~~pipeline~~ of ~~product candidates~~, ~~any~~and ~~additional~~limited ~~product~~reimbursement ~~candidates that we identify may not be suitable~~ for ~~clinical development or generate acceptable clinical data~~, ~~including~~new ~~as a result of being shown to have unacceptable effects or other characteristics that indicate~~therapies that they are unlikely to be products that will receive marketing approval from the FDA or other regulatory authorities or achieve market acceptance. If we do not successfully develop and commercialize product candidates, we will not be able to generate product revenue in ~~the~~ ~~future.~~many ~~Moreover,~~underdeveloped our ability to complete the clinical trial for EB103 or commence and complete a clinical trial for any other product candidate may depend on our ability to obtain sufficient funding from various sourcesmarkets. ~~If we fail to obtain adequate funding we may have to delay, reduce, or terminate our clinical development programs.~~

62Our management has a limited understanding of artificial intelligence (“AI”), and may not be able to fully assess potential risks posed to our business by AI or to capture any potential benefits to our business AI could provide. In the event AI is used to better effect by our competitors it could lead to countervailing discoveries that may undermine our current pipeline. Our limited understanding of AI could also lead to potential security risks and breaches.

~~Although~~The wepotential ~~intend~~adoption and tointegration ~~explore~~of ~~other~~Artificial ~~therapeutic~~Intelligence ~~opportunities~~(AI) in ~~addition~~our tooperations ~~the~~present ~~product~~a ~~candidates~~range of risks that wecould adversely affect our business. AI technologies are ~~currently~~evolving ~~developing~~rapidly, weand ~~may~~our ~~fail~~management has limited ability to ~~identify viable~~fully ~~new~~assess ~~product~~or ~~candidates~~predict ~~for~~the ~~clinical~~potential ~~development~~long-term ~~for~~risks aand ~~number~~disruptions they ofmay ~~reasons~~bring. IfAs AI technologies continue to develop, we ~~fail~~may face significant challenges in adapting to ~~identify~~new ~~additional~~market ~~potential~~conditions ~~product~~or ~~candidates,~~operational ~~our~~realities, ~~business~~as ~~could~~competitors bemay ~~materially~~leverage ~~harmed~~AI to gain competitive advantages or disrupt established business models.

Although a substantial amount of our efforts will focus on the planned clinical trials and potential approval of the current and potential future product candidates we are evaluating, we also intend to discover, develop, and globally commercialize additional targeted therapies beyond our current product candidates to treat various forms of cancer and in a variety of therapeutic areas. Even if we identify investigational therapies that initially show promise, we may fail to successfully develop and commercialize such products for many reasons, including the following:41

●Moreover, AI systems have the potential ~~research~~to ~~methodology~~make ~~used~~unforeseen or unintended discoveries that may ~~not~~disrupt beexisting ~~successful~~products, inservices, ~~identifying~~or ~~potential~~business ~~investigational~~strategies. ~~therapies;~~These countervailing discoveries could render our current operations or offerings obsolete, or cause unforeseen consequences that are difficult to mitigate. As AI-driven developments evolve, the risk of encountering these unintended outcomes increases, and our ability to anticipate or control them may be limited.

●Additionally, the rapid deployment of AI by competitors could create significant competitive risks. Competitors may be able to develop ~~alternatives~~or ~~that~~adopt ~~render~~AI technologies faster than we can, potentially outpacing our ~~investigational~~innovation ~~therapies~~or ~~obsolete;~~efficiency improvements. This could result in a loss of market share, reduced profitability, and increased difficulty in maintaining a competitive position within our industry.

●AI ~~investigational~~systems, ~~therapies~~if wenot ~~develop~~adequately secured, ~~may~~could ~~nevertheless~~expose beour ~~covered~~company byto ~~third~~cybersecurity ~~parties’~~threats, ~~patents~~including ordata ~~other~~breaches, ~~exclusive~~intellectual ~~rights;~~property theft, and system compromises. The exploitation of such vulnerabilities could lead to reputational damage, legal liabilities, and regulatory penalties.

●Given anthese ~~investigational~~risks, ~~therapy~~our management may, onnot ~~further~~be ~~study~~able to fully identify, beassess, ~~shown~~or toaddress ~~have~~all ~~harmful~~the ~~side~~potential ~~effects~~negative orconsequences ~~other~~associated ~~characteristics~~with ~~that~~AI. As ~~indicate~~such, itAI-related risks, isincluding ~~unlikely~~those tofrom becompetitors’ ~~effective~~advancements, orsecurity ~~otherwise~~breaches, ~~does~~and ~~not~~unforeseen ~~meet~~discoveries, ~~applicable~~could ~~regulatory~~materially ~~criteria;~~disrupt our operations and adversely affect our financial performance.

●We itface competition from companies that have developed or may ~~take~~develop ~~greater~~product ~~human~~candidates ~~and~~for ~~financial~~the ~~resources~~treatment ~~than~~of wethe ~~will~~diseases ~~possess~~that towe ~~identify~~may ~~additional~~target, ~~therapeutic~~including ~~opportunities~~companies ~~for~~developing novel ~~our~~therapies ~~product~~and ~~candidates~~platform ortechnologies. toIf these companies develop ~~suitable~~therapies ~~potential~~or ~~product~~platform ~~candidates~~technologies ~~through~~more ~~internal~~rapidly ~~research~~than ~~programs~~we do, ~~thereby~~or ~~limiting~~if their therapies or platform technologies are more effective or have fewer side effects, our ability to develop, ~~diversify~~ and ~~expand~~successfully ~~our~~commercialize therapies ~~product~~may ~~portfolio;~~be adversely affected.

●The andevelopment ~~investigational~~and ~~therapy~~commercialization of ~~may~~T-cell ~~not~~therapies beis ~~capable~~highly competitive. We compete with a variety of ~~being~~large ~~produced~~pharmaceutical incompanies, ~~clinical~~multinational orbiopharmaceutical companies, ~~commercial~~other ~~quantities~~biopharmaceutical companies, and specialized biotechnology companies, as well as technology and therapeutics being developed at anuniversities ~~acceptable~~and ~~cost~~other research institutions. Our competitors are often larger and better funded than we are. Our competitors have developed, are developing, or atwill ~~all;~~develop product candidates and processes competitive with ours. Competitive therapeutic treatments include those that have already been approved and accepted by the medical community and any new treatments that are currently in development or that enter the market. We believe that a significant number of product candidates are currently under development, and may become commercially available in the future, for the treatment of conditions for which we may try to develop product candidates. There is intense and rapidly evolving competition in the biotechnology and biopharmaceutical fields. We believe that while EB103, EB104, EB201 and research relating to the use of EB103 in conjunction with CF33-CD19t, their associated intellectual property, the characteristics of our current and potential future product candidates, and our scientific and technical know-how together give us a competitive advantage in this space, competition from many sources remains.

●Many anof ~~approved~~our competitors have significantly greater financial, technical, manufacturing, marketing, sales, and supply resources or experience than we do. If we successfully obtain approval for any product ~~may~~candidate, ~~not~~we will face competition based on many different factors, including the safety and effectiveness of our product candidates, the ease with which our product candidates can be ~~accepted~~administered, asthe ~~safe~~timing and ~~effective~~scope byof ~~trial~~regulatory ~~participants~~approvals for these product candidates, the ~~medical~~availability ~~community~~and cost of manufacturing, marketing and sales capabilities, price, reimbursement coverage, and patent position. Competing products and product candidates could present superior treatment alternatives, including by being more effective, safer, less expensive, or ~~third-party~~marketed ~~payors~~and sold more effectively than any products we may develop. Competitive products and product candidates may make any product we develop obsolete or noncompetitive before we recover the expense of developing and commercializing such product. Such competitors could also recruit our employees, which could negatively impact our level of expertise and our ability to execute our business plan.

Identifying new investigational therapies requires substantial technical, financial, and human resources, whether or not any investigational therapies are ultimately identified. Because we have limited financial and human resources, we may initially focus on research programs and product candidates for a limited set of indications. As a result, we may forgo or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential or a greater likelihood of success. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. For example, if we do not accurately evaluate the commercial potential or target market for a particular product candidate or technology, we may relinquish valuable rights to that product candidate or technology through collaborations, licensing, or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate or technology.42

~~Accordingly,~~Any ~~there~~inability ~~can be no assurance that we will ever be able~~ to ~~identify~~attract ~~additional~~and ~~therapeutic~~retain ~~opportunities for our product candidates or to develop suitable~~qualified ~~potential~~key ~~product candidates through internal research programs~~management, ~~which~~technical ~~could~~personnel ~~materially adversely affect our future growth~~ and ~~prospects. We~~employees ~~may~~would ~~focus~~impair our ~~efforts~~ability ~~and~~to ~~resources~~implement onour ~~potential~~business ~~product candidates or other potential programs that ultimately prove to be unsuccessful~~plan.

63Our success largely depends on the continued service of our and Eureka’s key executive management, advisors, and other specialized personnel. Our and Eureka’s senior management may terminate their employment with us and Eureka, as applicable, at any time. We do not maintain “key person” insurance for any of our employees. The loss of one or more members of our or Eureka’s executive team, management team, or other key employees or advisors could delay our research and development programs and have a material adverse effect on our business, financial condition, results of operations, and prospects.

~~The~~Recruiting ~~occurrence~~and ofretaining qualified ~~serious~~scientific ~~complications~~and orclinical ~~side~~personnel ~~effects~~and, inif ~~connection~~we ~~with~~progress ~~use~~the development of any of our product candidates, ~~either~~commercialization, inmanufacturing, and ~~clinical~~sales ~~trials~~and ormarketing ~~post-approval~~personnel, ~~could lead~~will be critical to ~~discontinuation~~our success. The loss of the services of members of our ~~clinical~~or Eureka’s senior management or other key employees could impede the achievement of our research, development, ~~programs~~and commercialization objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, ~~refusal~~replacing members of ~~regulatory~~our ~~authorities~~or Eureka’s senior management and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to ~~approve~~successfully develop, gain regulatory approval of, and commercialize our product candidates. orOur success also depends on our and Eureka’s ability to continue to attract, retain, and motivate highly skilled junior, ~~post~~mid-~~approval~~level, ~~revocation~~and ofsenior ~~marketing~~managers, ~~authorizations~~as orwell ~~refusal~~as and Eureka’s junior, mid-level, and senior scientific and medical personnel. Competition to ~~approve~~hire ~~applications~~from ~~for~~this ~~new~~limited ~~indications~~candidate pool is intense, ~~which~~and ~~could~~we ~~severely~~and ~~harm our~~Eureka ~~business~~may be unable to hire, ~~prospects~~train, ~~operating~~retain ~~results~~or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and ~~financial~~biotechnology ~~condition~~companies for similar personnel. We and Eureka also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.

~~Undesirable~~In ~~side effects caused by any of our current or potential future product candidates could cause regulatory authorities to interrupt~~addition, ~~delay~~through ~~or halt clinical trials and could result in a more restrictive label or~~ the ~~delay or denial of regulatory approval by the FDA or other regulatory authorities.~~Services ~~While~~Agreement wewith ~~have not yet initiated clinical trials for our product candidates~~Eureka, itwe isrely ~~likely~~on ~~that~~consultants ~~there will be side effects associated with their use. Results of our clinical trials could reveal a high~~ and ~~unacceptable severity and prevalence of these side effects. It is possible that safety events or concerns such as these or others could negatively affect the development of our product candidates~~advisors, including ~~adversely affecting~~scientific ~~patient~~and ~~enrollment~~clinical ~~among~~advisors, ~~the patient populations that we intend~~ to ~~treat.~~assist Inus ~~such~~in anformulating ~~event,~~ our ~~trials could be suspended or~~ ~~terminated,~~research and ~~the FDA or other regulatory authorities could order us to cease further~~ development ofand orcommercialization ~~deny approval of a product candidate for any or all targeted indications~~strategy. Such ~~side~~consultants ~~effects~~and ~~could~~advisors are also ~~affect~~consultants ~~patient~~and ~~recruitment~~advisors orto ~~the~~Eureka, ~~ability~~and may ofhave ~~enrolled~~additional ~~patients~~commitments tounder ~~complete the~~consulting ~~trial~~ or ~~result~~advisory incontracts ~~potential~~with ~~product~~other ~~liability~~entities, ~~claims. There can be no guarantee~~ that ~~our~~may ~~current~~limit ortheir ~~future~~availability ~~product~~to ~~candidates~~us ~~will~~and ~~not~~adversely ~~cause~~impact ~~such~~the ~~effects~~benefits inwe ~~clinical~~realize ~~trials.~~from ~~Any~~the ofServices ~~these~~Agreement ~~occurrences may materially~~ and ~~adversely affect~~ our ~~business~~research and ~~financial~~development ~~condition~~ and ~~impair~~commercialization ~~our ability to generate revenues~~strategy.

~~Further,~~We clinical trials by their nature utilize a sample of the potential patient population. With a limited number of patients and limited duration of exposure, rare and severe side effects of a product candidate may ~~only~~experience bedifficulties ~~uncovered~~in ~~when a significantly larger number of patients are exposed to~~managing ~~the~~our ~~product~~growth ~~candidate~~and orexpanding ~~when~~our ~~patients are exposed for a longer period of time~~operations.

InAs ~~the event that any of~~ our current orand potential future product candidates ~~receives~~enter ~~regulatory approval~~ and weadvance orthrough ~~others~~preclinical ~~identify~~studies ~~undesirable~~and ~~side~~any ~~effects~~clinical ~~caused by one of these products~~trials, ~~any~~we ofwill ~~the~~need ~~following~~to ~~events~~expand ~~could~~our ~~occur~~development, regulatory, ~~which~~and ~~could~~manufacturing ~~result~~capabilities inor ~~the~~contract ~~loss~~with ofother ~~significant~~organizations ~~revenue~~ to usprovide ~~and~~these ~~materially and~~capabilities ~~adversely~~for ~~affect our results of operations and business:~~us.

●To ~~regulatory~~manage ~~authorities~~our anticipated future growth, we will continue to implement and improve our managerial, operational, and financial systems and continue to recruit and train additional qualified personnel. Due to our limited financial resources and the complexity in managing a company with such anticipated growth, we may ~~withdraw~~not ~~their~~be ~~approval~~able ofto effectively manage the ~~product~~expansion of our operations or ~~seize~~recruit and train additional qualified personnel. The expansion of our operations may lead to significant costs and may divert our management and business development resources. Any inability to manage growth could delay the ~~product;~~execution of our business plans or disrupt our operations.

●In weaddition, ~~may~~future begrowth imposes ~~required~~significant toadded ~~recall~~responsibilities ~~the~~on ~~product~~members orof ~~change~~management, ~~the~~including: ~~way~~identifying, recruiting, integrating, maintaining, and motivating additional employees; managing our internal development efforts effectively, including the clinical and FDA review process for our product iscandidates, ~~administered~~while complying with our contractual obligations to ~~patients~~contractors and other third parties; and improving our operational, financial and management controls, reporting systems and procedures.

●We ~~additional restrictions~~ may bealso ~~imposed~~experience ondifficulties in the ~~marketing~~discovery and development of ~~the~~potential ~~particular~~future product orcandidates if we are unable to meet demand as we grow our operations. In the ~~manufacturing~~future, ~~processes~~we also expect to have to manage additional relationships with collaborators, suppliers, and other organizations. Our ability to manage our operations and future growth will require us to continue to improve our operational, financial, and management controls, reporting systems, and procedures, and to secure adequate facilities for ~~the~~our ~~product~~operational needs. We may not be able to implement improvements to our management information and control systems in an efficient or ~~any~~timely ~~component~~manner ~~thereof;~~and may discover deficiencies in existing systems and controls.

~~● we may be subject to fines, injunctions, or the imposition of civil or criminal penalties;~~43

●If ~~regulatory~~any ~~authorities~~of ~~may~~our ~~require~~product candidates is approved for marketing and commercialization in the ~~addition~~future ofand ~~labeling~~we ~~statements~~are unable to develop sales, ~~such~~marketing, asand adistribution ~~“black~~capabilities ~~box”~~on ~~warning~~our own or aenter ~~contraindication;~~into agreements with third parties to perform these functions on acceptable terms, we will be unable to successfully commercialize any such future products.

●We wewill ~~may~~need to develop internal sales, marketing, and distribution capabilities to commercialize each current and potential future product candidate that gains, if ever, FDA or other regulatory authority approval, which would be ~~required~~expensive and time-consuming, or enter into collaborations with third parties to ~~create~~perform these services. If we decide to market any approved products directly, we will need to commit significant financial and managerial resources to develop a ~~medication~~marketing ~~guide~~and ~~outlining~~sales force with technical expertise and supporting distribution, administration, and compliance capabilities. If we rely on third parties with such capabilities to market any approved products or decide to co-promote products with third parties, we will need to establish and maintain marketing and distribution arrangements with third parties, and there can be no assurance that we will be able to enter into such arrangements on acceptable terms or at all. In entering into third-party marketing or distribution arrangements, any revenue we receive will depend upon the ~~risks~~efforts of the third parties and we cannot assure you that such third ~~side~~parties ~~effects~~will ~~for~~establish adequate sales and distribution tocapabilities ~~patients;~~or be successful in gaining market acceptance for any approved product. If we are not successful in commercializing any product approved in the future, either on our own or through third parties, our business and results of operations could be materially and adversely affected.

●Public weopinion ~~could~~and bescrutiny ~~sued~~of immunotherapy approaches may impact public perception of Estrella and ~~held~~product ~~liable~~candidates, ~~for~~or ~~harm~~may ~~caused~~adversely affect our ability to ~~patients;~~conduct our business and our business plans.

●Public perception may be influenced by claims, such as claims that immunotherapies are unsafe, unethical, or immoral and, consequently, our approach may not gain the acceptance of the public or the medical community. Negative public reaction to immunotherapy in general could result in greater government regulation and stricter labeling requirements of immunotherapy products, including any of our product candidates, and could cause a decrease in the demand for any products we may ~~become~~develop. ~~less~~Adverse ~~competitive;~~public attitudes may adversely impact our ability to enroll clinical trials. Moreover, our success will depend upon physicians specializing in the treatment of those diseases that our product candidates target prescribing, and their patients being willing to receive, treatments that involve the use of our product candidates in lieu of, or in addition to, existing treatments they are already familiar with and for which greater clinical data may be available. More restrictive government regulations or negative public opinion could have an adverse effect on our business or financial condition and may delay or impair the development and commercialization of our product candidates or demand for any products we may develop. Adverse events in our clinical trials, even if not ultimately attributable to our product candidates, and the resulting publicity could result in increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of our potential product candidates, stricter labeling requirements for those product candidates that are approved and a decrease in demand for any such product candidates.

●Our ~~our~~potential ~~reputation~~future international operations may ~~suffer~~expose us to business, political, operational, and financial risks associated with doing business outside of the United States.

~~Any~~Our business is subject to risks associated with conducting business internationally. Some of ~~these~~our ~~events~~future ~~could~~clinical trials may be conducted outside of the United States ~~prevent~~and uswe ~~from~~may ~~achieving~~enter into key supply arrangements or ~~maintaining~~do ~~market~~other ~~acceptance~~business with persons outside of the ~~particular~~United States. ~~product candidate~~Furthermore, if ~~approved~~we or any future collaborator succeeds in developing any products, ~~and~~we ~~could~~anticipate ~~significantly~~marketing ~~harm~~them in the European Union and other jurisdictions ~~our~~in ~~business~~addition to the United States. If approved, ~~results~~we ofor ~~operations~~any future collaborator may hire sales representatives and ~~prospects~~conduct physician and patient association outreach activities outside of the United States. Doing business internationally involves a number of risks, including but not limited to:

64● multiple, conflicting, and changing laws and regulations such as those relating to privacy, data protection and cybersecurity, tax laws, export and import restrictions, employment laws, regulatory requirements, and other governmental approvals, permits and licenses;

~~While~~● ~~our~~failure ~~IND for EB103 was cleared~~ by ~~the~~us ~~FDA on March 2, 2023 and we believe our pipeline will yield additional INDs, we may not be able~~ to ~~file~~obtain ~~additional INDs to commence clinical trials on the timelines we expect,~~ and ~~even~~maintain ifregulatory weapprovals ~~are~~for ~~able to,~~ the ~~FDA~~commercialization ~~may~~of ~~not~~our ~~permit~~product uscandidates toin ~~proceed.~~various countries;

~~While~~● werejection ~~expect~~or ~~our~~qualification ~~pipeline to~~of ~~yield~~foreign ~~multiple~~clinical ~~INDs~~trial indata ~~addition to the IND for EB103, which was cleared~~ by the ~~FDA~~competent onauthorities ~~March 2, 2023, we cannot be sure that submission~~ of ~~future INDs will result in the FDA allowing testing and clinical trials to begin, or that, once clinical trials for EB103 or~~ other ~~product~~ candidates begin, issues will not arise that suspend or terminate such clinical trials. The manufacturing of our product candidates, including EB104, remain an emerging and evolving field. Accordingly, we expect CMC-related topics, including product specifications, will be a focus of IND reviews, which may delay the clearance of INDs.countries;

~~Additionally,~~● ~~even~~additional ifpotentially ~~such regulatory~~relevant ~~authorities~~third-party ~~agree~~patent with the design and implementation of the clinical trials set forth in an IND or clinical trial application, we cannot guarantee that such regulatory authorities will not change their requirements in the future.rights;

In● ~~addition~~complexities to the submission of an IND to the FDA before initiation of a clinical trial in the United States, certain human clinical trials involving recombinant or synthetic nucleic acid molecules are subject to oversight of institutional biosafety committees (“IBCs”), as set forth in the National Institutes of Health (“NIH”) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (“NIH Guidelines”). Under the NIH Guidelines, recombinant and ~~synthetic~~difficulties ~~nucleic acids are defined as: (i) molecules that are constructed by joining nucleic acid molecules and that can replicate~~ in ~~a living cell (i.e.~~obtaining, ~~recombinant nucleic acids); (ii) nucleic acid molecules that are chemically or by other means synthesized or amplified~~maintaining, ~~including~~protecting those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids); or (iii) molecules that result from the replication of those described in (i) or (ii). Specifically, under the NIH Guidelines, supervision of human gene transfer trials includes evaluation and ~~assessment~~enforcing byour anintellectual ~~IBC,~~property a local institutional committee that reviews and oversees research utilizing recombinant or synthetic nucleic acid molecules at that institution. The IBC assesses the safety of the research and identifies any potential risk to public health or the environment, and such review may result in some delay before initiation of a clinical trial. While the NIH Guidelines are not mandatory unless the research in question is being conducted at or sponsored by institutions receiving NIH funding of recombinant or synthetic nucleic acid molecule research, many companies and other institutions not otherwise subject to the NIH Guidelines voluntarily follow them.rights;

~~Interim,~~● ~~topline and~~difficulties ~~preliminary~~in ~~data~~staffing ~~that we announce or publish from time to time for any clinical trials that we initiate may change as more patient data become available or as additional analyses are conducted,~~ and asmanaging ~~the~~foreign ~~data are subject to audit and verification procedures that could result in material changes in the final data.~~operations;

From time to time, we may publicly disclose interim, preliminary, or topline data from our preclinical studies and clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular trial. We also make assumptions, estimations, calculations, and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, preliminary, or topline results that we report may differ from future results of the same trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available. From time to time, we may also disclose interim, preliminary, or topline data from our clinical studies. 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 more patient data become available. Adverse differences between preliminary, topline, or interim data and final data could significantly harm our business prospects.44

~~Further,~~● ~~others,~~complexities ~~including regulatory~~associated ~~agencies, may not accept or agree~~ with ~~our~~managing ~~assumptions,~~multiple ~~estimates,~~payor ~~calculations,~~reimbursement ~~conclusions~~regimes, orgovernment ~~analyses~~payors or ~~may~~patient ~~interpret or~~self-pay weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and the value of 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 you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product, product candidate or our business. If the topline data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects, or financial condition.systems;

65● limits in our ability to penetrate international markets;

We● ~~and~~financial ~~our~~risks, ~~collaborators may~~such ~~not~~as ~~achieve~~longer ~~projected~~payment ~~discovery~~cycles, ~~and~~difficulty ~~development~~collecting ~~milestones~~accounts ~~and~~receivable, ~~other~~the ~~anticipated~~impact ~~key~~of ~~events~~local inand ~~the~~regional ~~time~~financial ~~frames~~crises ~~that~~on ~~we or they announce~~demand, ~~which~~ ~~could~~and ~~have~~payment anfor ~~adverse impact on~~ our ~~business~~products and ~~could~~exposure ~~cause~~to ~~our~~foreign ~~stock~~currency ~~price~~exchange torate ~~decline.~~fluctuations;

~~From~~● ~~time~~natural ~~to time~~disasters, wepolitical ~~expect that we will make public statements regarding the expected timing of certain milestones~~ and ~~key~~economic ~~events~~instability, ~~such~~including aswars, ~~the~~terrorism ~~commencement~~ and ~~completion of~~political preclinical and IND-enabling studies in our product candidate discovery programs with collaborators as well as the commencement and completion of planned clinical trials in those programs. The actual timing of these events can vary dramatically due to a number of factors such as delays or failures in our or any current or future collaborators’ product candidate discovery and development programsunrest, ~~the~~ ~~amount~~outbreak of ~~time~~disease, ~~effort and resources committed by us and any current or future collaborators~~boycotts, ~~and~~curtailment ~~the numerous uncertainties inherent in the development~~ of ~~therapies. As a result~~trade, ~~there~~and can be no assurance that our or any current or future collaborators’ programs will advance or be completed in the time frames we or they announce or expect. If we or any collaborators fail to achieve one or more of these milestones or other ~~key events as planned, our~~ business ~~could be materially adversely affected, and the price of our Common Stock could decline.~~restrictions;

~~Clinical~~● ~~trials are~~certain ~~expensive~~expenses including, ~~time-consuming~~among others, ~~and~~expenses ~~difficult~~for totravel, ~~design~~translation, and ~~implement.~~insurance; and

~~Human~~● ~~clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous~~ regulatory ~~requirements. Because our current~~ and ~~potential~~compliance ~~future~~risks ~~product candidates are based on new technologies and discovery approaches, we expect~~ that ~~they~~relate ~~will require extensive research and development and have substantial manufacturing and processing costs. In addition, the FDA or other regulatory authorities may require us~~ to ~~perform~~anti-corruption ~~additional~~compliance ~~testing before commencing clinical trials~~ and be hesitant to allow us to enroll patients impacted with our targeted disease indications in our future clinical trials. If we are unable to enroll patients impacted by our targeted disease indications in our future clinical trials, we would be delayed in obtaining potential proofrecord-~~of-concept~~keeping ~~data in humans, which could extend our development timelines. In addition, costs to treat patients and to treat potential side effects~~ that may ~~result~~fall ~~from~~within ~~our~~the ~~product~~purview ~~candidates may~~of bethe ~~significant~~U.S. ~~Accordingly,~~Foreign ~~our~~Corrupt ~~clinical~~Practices ~~trial~~Act, ~~costs~~its ~~are~~accounting ~~likely~~provisions toor beits ~~high~~anti-bribery ~~and~~provisions ~~could~~or ~~have~~provisions aof ~~material~~anti-corruption ~~adverse~~or ~~effect~~anti-bribery onlaws ~~our~~in ~~business, financial~~other ~~condition, results of operations and prospects~~countries.

IfAny weof ~~encounter~~these factors could ~~difficulties~~harm ~~enrolling~~our ~~patients~~ongoing ininternational ~~our~~operations ~~clinical~~and ~~trials~~supply chain, ~~our~~as ~~clinical~~well ~~development~~as ~~activities~~any ~~could~~future beinternational ~~delayed~~expansion orand ~~otherwise~~operations ~~adversely~~and, ~~affected~~consequently, our business, financial condition, prospects and results of operations.

WeOur ~~may~~business ~~not~~entails bea ~~able~~significant ~~to initiate~~risk orof ~~continue~~product ~~any~~liability, ~~clinical~~and ~~trials for~~ our ~~current~~inability ~~or potential future product candidates if we are unable~~ to ~~locate~~obtain ~~and enroll a~~ sufficient ~~number~~ ofinsurance ~~eligible~~coverage ~~patients~~could tohave ~~participate~~a inmaterial ~~these~~adverse ~~trials~~effect ason ~~required~~our ~~by the FDA or other regulatory authorities. We cannot predict how~~business, ~~difficult~~financial itcondition, ~~will~~results ~~be to enroll patients for trials in the indications we are studying. We may experience difficulties in patient enrollment in our clinical trials for a variety~~ of ~~reasons.~~operations ~~The~~and ~~enrollment of patients depends on many factors, including:~~prospects.

●As ~~the~~we ~~severity~~conduct preclinical studies and future clinical trials of our current and potential future product candidates, we will be exposed to significant product liability risks inherent in the ~~disease~~development, ~~under~~testing, manufacturing, and marketing of these product candidates. Product liability claims could delay or prevent completion of our development programs. If we succeed in marketing products, such claims could result in an FDA investigation; of the safety and effectiveness of our products, our manufacturing processes and facilities or our marketing programs and potentially a recall of our products or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in decreased demand for our products, injury to our reputation, costs to defend the related litigation, a diversion of management’s time and our resources, substantial monetary awards to trial participants or patients and a decline in our stock price. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we or any future collaborators may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have a material adverse effect on our business, financial condition, results of operations and prospects.

●Our ~~patient~~employees, ~~eligibility~~principal ~~criteria~~investigators, consultants, ~~defined~~and commercial collaborators may engage in ~~the~~misconduct ~~clinical~~or ~~trial~~other ~~protocol;~~improper activities, including noncompliance with regulatory standards and requirements.

●We are exposed to the risk ~~size~~of fraud or other misconduct by our employees, principal investigators, consultants, and commercial collaborators. Misconduct by employees could include intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards we may establish, comply with federal and state healthcare fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to us. In particular, sales, marketing, and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Such misconduct could also involve the ~~patient~~improper ~~population~~use ~~required~~of ~~for~~information ~~analysis~~obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter misconduct, and the ~~trial’s~~precautions ~~primary~~we ~~endpoints;~~take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a material adverse effect on our business and financial condition, including the imposition of significant criminal, civil and administrative fines or other sanctions, such as monetary penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government-funded healthcare programs, such as Medicare and Medicaid, integrity obligations, reputational harm and the curtailment or restructuring of our operations.

~~● the proximity and availability of clinical trial sites for prospective patients;~~45

●We ~~willingness~~depend ofon ~~physicians~~sophisticated information technology systems and data processing to ~~refer~~operate ~~their~~our ~~patients~~business. If we experience security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our ~~clinical~~proprietary ~~trials;~~or confidential data, employee data or personal data, we may face costs, significant liabilities, harm to our brand, and business disruption.

66We rely on information technology systems and data processing that we or our service providers, collaborators, consultants, contractors, or partners operate to collect, process, transmit and store electronic information in our day-to-day operations, including a variety of personal data, such as name, mailing address, email addresses, phone number and potentially clinical trial information. Additionally, we, and our service providers, collaborators, consultants, contractors or partners, do or will collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, and share personal information, health information, and other information to host or otherwise process some of our anticipated future clinical data and that of users, to develop our products, to operate our business, for clinical trial purposes, for legal and marketing purposes, and for other business-related purposes. Our internal computer systems and data processing and those of our third-party vendors, consultants, collaborators, contractors, or partners, including future CROs may be vulnerable to a cyber-attack (including supply chain cyber-attacks), malicious intrusion, breakdown, destruction, loss of data privacy, actions or inactions by our employees or contractors that expose security vulnerabilities, theft, or destruction of intellectual property or other confidential or proprietary information, business interruption or other significant security incidents. As the cyber-threat landscape evolves, these attacks are growing in frequency, level of persistence, sophistication, and intensity, and are becoming increasingly difficult to detect. In addition to traditional computer “hackers,” threat actors, software bugs, malicious code (such as viruses and worms), employee theft or misuse, denial-of-service attacks (such as credential stuffing), phishing and ransomware attacks, sophisticated nation-state and nation-state supported actors now engage in attacks (including advanced persistent threat intrusions). Furthermore, because the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched against a target, we may be unable to anticipate these techniques or implement adequate preventative measures. We may also experience security breaches that may remain undetected for an extended period.

●Our IT infrastructure is limited given the size and scope of our ~~ability~~operations, and we have not conducted a formal standalone IT or cybersecurity risk assessment, nor do we have a dedicated cybersecurity officer. Our process for assessing, identifying and managing cybersecurity risks is not fully integrated into an enterprise-wide risk management program, and we do not have a formal internal process to oversee ~~recruit~~and ~~clinical~~identify ~~trial~~cybersecurity ~~investigators~~threats and risks associated with our reliance on Eureka’s third-party IT support provider. Instead, we have adopted cybersecurity principles modeled on those used by Eureka, and our IT support is outsourced to Eureka’s third-party provider. While we have implemented certain technical and organizational measures — including reliance on cloud-based storage (rather than on-premises servers) with daily backups and periodic restore testing, multi-factor authentication for access to our Office 365 environment, role-based access controls for financial data stored on SharePoint, and email protections such as spam/malware filtering, data loss prevention and basic encryption — these measures are limited and evolving and may prove inadequate to prevent or detect all cybersecurity threats. Cybersecurity oversight for Estrella is integrated into Eureka’s IT governance framework and the ~~appropriate~~third-party ~~competencies~~IT provider, and ~~experience;~~although our CEO and board receive updates and are responsible for ensuring that cybersecurity measures relevant to Estrella are in place, our dependence on Eureka’s IT Governance Committee and its external IT provider may reduce our direct visibility into, and control over, certain cybersecurity risks.

●There ~~clinicians’~~can be no assurance that we, our service providers, collaborators, consultants, contractors, or partners will be successful in efforts to detect, prevent or fully recover systems or data from all breakdowns, service interruptions, attacks or breaches of systems that could adversely affect our business and operations and/or result in the loss of critical or sensitive data. Any failure by us or our service providers, collaborators, consultants, contractors or partners to detect, prevent, respond to or mitigate security breaches or improper access to, use of, or inappropriate disclosure of any of this information or other confidential or sensitive information, including patients’ ~~perceptions~~personal asdata, toor the perception ~~potential~~that ~~advantages~~any such failure has occurred, could result in claims, litigation, regulatory investigations and other proceedings, significant liability under state, federal and international law, and other financial, legal or reputational harm to us. Further, such failures or perceived failures could result in liability and a material disruption of ~~the~~our ~~product~~development ~~candidate~~programs ~~being~~and ~~studied~~our business operations, which could lead to significant delays or setbacks in ~~relation~~our research, delays to ~~other~~commercialization ~~available~~of ~~therapies~~our product candidates, ~~including~~lost revenues, or other adverse consequences, any ~~new~~of ~~drugs~~which ~~that~~could ~~may~~have bea ~~approved~~material ~~for~~adverse effect on our business, results of operations, financial condition, prospects and cash flow. For example, the ~~indications~~loss weor ~~are~~alteration ~~investigating;~~of clinical trial data from future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

~~● our ability to obtain and maintain patient consents;~~46

●Additionally, applicable laws and regulations relating to privacy, data protection or cybersecurity, external contractual commitments, and internal privacy and security policies may require us to notify relevant stakeholders if there has been a security breach, including affected individuals, business partners and regulators. Such disclosures are costly, and the ~~risk~~disclosures ~~that~~or ~~patients~~any ~~enrolled~~actual or alleged failure to comply with such requirements could lead to a materially adverse impact on the business, including negative publicity, a loss of confidence in ~~clinical~~our ~~trials~~services ~~will~~or ~~drop~~security measures ~~out~~by our business partners or breach of contract claims. There can be no assurance that the ~~trials~~limitations ~~before~~of ~~completion;~~liability ~~and~~in our contracts would be enforceable or adequate or would otherwise protect us from liabilities or damages if we fail to comply with applicable data protection laws, privacy policies or other data protection obligations related to information security or security breaches.

●If ~~factors~~ we ~~may~~do not becomply ~~able~~with tolaws ~~control,~~regulating the ~~such~~protection asof ~~current or potential pandemics, including~~ the ~~COVID-19~~environment ~~pandemic,~~and ~~that~~health ~~may~~and ~~limit~~human ~~the availability of patients~~safety, ~~principal~~our ~~investigators~~business orcould ~~staff~~be oradversely ~~clinical sites to participate in our clinical trials~~affected.

InWe ~~addition,~~are ~~our~~subject ~~future~~to ~~clinical~~numerous ~~trials~~environmental, ~~will~~health, ~~compete~~and ~~with~~safety ~~other~~laws ~~clinical~~and ~~trials~~regulations, ~~for~~including ~~product~~those ~~candidates~~governing ~~that~~laboratory ~~are~~procedures inand the ~~same~~handling, ~~therapeutic~~use, ~~areas as our product candidates~~storage, treatment and ~~this~~disposal ~~competition~~of ~~will~~hazardous ~~reduce~~materials ~~the number~~ and ~~types~~wastes. ofOur ~~patients~~operations ~~available~~involve tothe ~~us,~~use ~~because~~of ~~some~~hazardous ~~patients~~materials, ~~who~~including ~~might~~chemicals ~~have opted to enroll~~and inbiological ~~our~~materials. ~~trials~~Our ~~may~~operations ~~instead~~also ~~opt~~produce tohazardous ~~enroll~~waste inproducts. aWe ~~trial~~generally ~~being~~contract ~~conducted~~with bythird ~~one~~parties offor ~~our competitors. Since~~ the ~~number~~ disposal of ~~qualified~~these ~~clinical~~materials ~~investigators is~~and ~~limited,~~wastes. weWe ~~expect~~cannot toeliminate ~~conduct~~the ~~some~~risk of ~~our~~contamination ~~clinical~~or ~~trials~~injury atfrom ~~the~~these ~~same~~materials. ~~clinical~~In ~~trial~~the ~~sites~~event ~~that some~~ of ~~our competitors use, which~~contamination ~~will~~or ~~reduce~~injury ~~the~~resulting ~~number~~from ~~of patients who are available for~~ our ~~clinical~~use ~~trials~~of athazardous ~~such clinical trial sites. Additionally~~materials, ~~because~~we ~~some of~~could ~~our clinical trials will~~ be inheld ~~patients~~liable ~~with~~for ~~advanced~~any ~~disease~~resulting ~~who~~damages, ~~may~~and ~~experience~~any ~~disease~~liability ~~progression~~could ~~or adverse events independent~~exceed ~~from~~ our ~~product candidates, such patients may be unevaluable for purposes of the trial and, as a result, we may require additional enrollment~~resources. ~~Delays~~ inWe ~~patient~~also ~~enrollment~~could ~~may~~incur ~~result~~significant ~~in increased~~ costs orassociated ~~may~~with ~~affect~~civil ~~the timing~~ or ~~outcome~~criminal offines ~~the planned clinical trials, which could prevent completion of these trials~~ and ~~adversely~~penalties ~~affect~~for ~~our~~failure ~~ability~~ to ~~advance~~comply ~~the~~with such ~~development~~laws ofand ~~our product candidates~~regulations.

IfAlthough ~~clinical~~we ~~trials~~maintain insurance to cover us for costs and expenses, we may incur due to injuries to our ~~product~~employees ~~candidates~~resulting ~~are~~from ~~prolonged,~~the ~~delayed~~use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic ~~stopped~~tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials. In addition, we may beincur ~~unable~~substantial costs in order to ~~seek~~comply with current or ~~obtain~~future ~~regulatory~~environmental, ~~approval~~health and ~~commercialize~~safety laws and regulations. ~~our~~These ~~product~~current ~~candidates~~or onfuture alaws ~~timely~~and ~~basis,~~regulations ormay atimpair ~~all~~our research, ~~which~~development, ~~would~~or ~~require~~production usefforts. Our failure to ~~incur~~comply ~~additional~~with ~~costs~~these laws and ~~delay~~regulations ~~our~~also ~~receipt~~may ofresult ~~any~~in ~~product revenue~~substantial fines, penalties, or other sanctions.

WeOur ~~may~~business, ~~experience~~operations, ~~delays~~financial ~~in our~~position ~~ongoing~~and ~~or future preclinical studies or~~ clinical ~~trials,~~development plans and wetimelines docould ~~not~~be ~~know~~materially adversely ~~whether~~affected ~~future~~by ~~preclinical~~the ~~studies~~continuing ormilitary ~~clinical~~action ~~trials will~~in ~~begin on time~~Ukraine, ~~need~~the towar bebetween ~~redesigned,~~Israel ~~enroll~~and ~~an adequate number of patients on time~~Hamas, orand bethe ~~completed~~armed onconflict ~~schedule,~~between ~~if at all. The~~the ~~commencement~~United orStates/Israel ~~completion~~and ~~of these clinical trials could be substantially delayed or prevented by many factors, including:~~Iran.

●As ~~further~~a ~~discussions~~result ~~with~~of the ~~FDA~~military oraction ~~comparable~~commenced ~~foreign~~in ~~regulatory~~February ~~authorities~~2022 ~~regarding~~by the ~~scope~~Russian Federation and Belarus in Ukraine, the war between Israel and Hamas commenced in October 2023, and the armed conflict commenced on February 28, 2026 by the United States and Israel against Iran (including joint airstrikes targeting Iranian leadership, nuclear facilities, ballistic missile programs, and military sites, with Iranian retaliatory missile and drone strikes on US bases, Israel, and Gulf states), and related economic sanctions imposed or ~~design~~that ofmay in the future be imposed by certain governments, our ~~clinical~~financial ~~trials~~position and operations may be materially and adversely affected. As our ability to continue to operate will be dependent on raising debt and equity finance, any adverse impact to those markets as a result of these conflicts, including ~~the~~due ~~endpoint~~to ~~measures~~increased ~~required~~market ~~for~~volatility ~~regulatory~~(such ~~approval~~as surges in energy prices), decreased availability in third-party financing and/or a deterioration in the terms on which it is available (if at all), could negatively impact our ~~statistical~~business, results ~~plan;~~of operations, cash flows, financial condition, and/or prospects. The extent of any potential impact is not yet determinable, however.

● the limited number of, and competition for, suitable study sites and investigators to conduct our clinical trials, many of which may already be engaged in other clinical trial programs with similar patients, including some that may be for the same indications as our product candidates;47

●Recent ~~any~~volatility ~~delay~~in orcapital ~~failure~~markets and lower market prices for our securities may affect our ability to ~~obtain~~access ~~timely~~new ~~approval~~capital through sales of shares of our Common Stock or ~~agreement~~issuance of indebtedness, which may harm our liquidity, limit our ability to ~~commence~~grow aour ~~clinical~~business, ~~trial~~pursue inacquisitions ~~any~~or ofimprove ~~the~~our ~~countries~~operating ~~where~~infrastructure and ~~enrollment~~restrict isour ~~planned;~~ability to compete in our markets.

●Our ~~inability~~operations consume substantial amounts of cash, and we intend to ~~obtain~~continue ~~sufficient~~to ~~funds~~make ~~required~~significant ~~for~~investments ato ~~clinical~~support ~~trial;~~our business growth, respond to business challenges or opportunities, develop new solutions, retain or expand our current levels of personnel, improve our existing solutions, enhance our operating infrastructure, and potentially acquire complementary businesses and technologies. Our future capital requirements may be significantly different from our current estimates and will depend on many factors, including the need to:

● ~~clinical~~finance ~~holds~~unanticipated ~~on,~~working orcapital ~~other regulatory objections to, a new or ongoing clinical trial~~requirements;

● ~~delay~~develop or ~~failure~~enhance toour ~~manufacture~~technological ~~sufficient~~infrastructure ~~quantities or inability to produce quantities of consistent quality, purity~~ and ~~potency of the product candidate for~~ our ~~clinical~~existing ~~trials~~solutions;

67● pursue acquisitions or other strategic relationships; and

● ~~delay~~respond ~~or failure~~ to ~~reach~~competitive agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites or CROs, the terms of which can be subject to extensive negotiation and may vary significantly among different sites or CROs;pressures.

●Accordingly, ~~delay~~we may need to pursue equity or ~~failure~~debt financings to meet our capital needs. With uncertainty in the capital markets and other factors, such financing may not be available on terms favorable to us or at all. If we raise additional funds through further issuances of equity or convertible debt securities, our existing stockholders could suffer significant dilution, and any new equity securities we issue could have rights, preferences, and privileges superior to those of holders of Estrella common stock. Any debt financing secured by us in the future could involve additional restrictive covenants relating to our capital-raising activities and other financial and operational matters, which may make it more difficult for us to obtain ~~institutional~~additional ~~review~~capital ~~board~~and ~~(“IRB”)~~to pursue business opportunities, including potential acquisitions. If we are unable to obtain adequate financing or ~~ethics~~financing ~~committee~~on ~~approval~~terms satisfactory to ~~conduct~~us, awe ~~clinical~~could ~~trial~~face atsignificant alimitations ~~prospective~~on ~~site;~~our ability to invest in our operations and otherwise suffer harm to our business.

●Inflation ~~the~~and ~~FDA~~higher orinterest ~~other~~rates ~~comparable~~could increase ~~foreign~~our ~~regulatory~~operating ~~authorities~~costs ~~may~~and ~~require~~adversely usaffect toour ~~submit~~liquidity ~~additional~~and ~~data~~ability ~~or impose other requirements before permitting us~~ to ~~initiate~~raise ~~a clinical trial;~~capital.

●While ~~slower~~inflation ~~than~~in ~~expected~~the United States has moderated since its recent peak in June 2022, it remains above the Federal Reserve’s long-term 2.0% target, and interest rates ofremain ~~patient~~elevated ~~recruitment~~compared to the decade prior to the COVID-19 pandemic. Higher inflation and ~~enrollment;~~a sustained higher-rate environment may result in increased operating costs, reduced liquidity, lower valuations, and limitations on our ability to access credit or otherwise raise debt and equity capital on acceptable terms. In addition, continued volatility in financial markets, uncertainty around future monetary policy, and any renewed increase in inflationary pressures may further heighten these risks.

●Risks ~~failure~~Related ofto ~~patients~~the toSeparation ~~complete~~and ~~the~~Our ~~clinical~~Relationship with ~~trial;~~Eureka

●We ~~the~~will ~~inability~~incur toincremental ~~enroll~~costs as a ~~sufficient~~standalone public ~~number of patients in studies to ensure adequate statistical power to detect statistically significant treatment effects;~~company.

●For ~~unforeseen~~operational ~~safety~~matters ~~issues~~outside of the scope of the Services Agreement we entered with Eureka, ~~including~~we ~~severe~~may orhire ~~unexpected~~additional ~~drug~~employees, or out-~~related~~source ~~adverse~~certain ~~effects~~functions, ~~experienced~~systems, and byinfrastructure ~~patients~~through contracts with third parties. These initiatives may be costly to implement. To the extent we implement any of these initiatives, ~~including~~we ~~possible~~may ~~deaths;~~incur additional operating costs, and the amount and timing of such costs is uncertain.

●Eureka ~~lack~~currently performs or supports many important corporate functions for us pursuant to the Services Agreement. The Services Agreement may be terminated by mutual agreement at any time. Following the termination of, ~~efficacy~~or the expiration of the term of, the Services Agreement, we may not be able to replace the services or ~~failure~~enter into appropriate third-party arrangements on terms and conditions, including cost, comparable to ~~measure~~those athat ~~statistically~~we ~~significant~~will ~~clinical~~receive ~~benefit~~from ~~within~~Eureka under our Services Agreement. Additionally, after the ~~dose~~Services ~~range~~Agreement terminates, ~~with~~we anmay ~~acceptable~~be ~~safety~~unable ~~margin~~to ~~during~~sustain ~~clinical~~the ~~trials;~~services at the same levels or obtain the same benefits as when we were receiving such services and benefits from Eureka. If we are required to operate these functions separately in the future, and we do not have our own adequate systems and business functions in place at that time, or are unable to obtain them from other providers, we may not be able to operate our business effectively or at comparable costs, and our profitability may decline.

●We ~~termination~~also ofshare office space with Eureka pursuant to an office sharing agreement that commenced in August 2022. If Eureka were to leave or lose its office space, we may not have adequate facilities to operate our ~~clinical~~business ~~trials~~effectively and as required by ~~one~~the Collaboration Agreement or ~~more~~the ~~clinical~~costs ~~trial~~of our ~~sites;~~office space could increase.

~~● inability or unwillingness of patients or clinical investigators to follow our clinical trial protocols;~~48

●Certain ~~inability~~of toour ~~monitor~~officers ~~patients~~or ~~adequately~~directors ~~during~~may have actual or ~~after~~potential ~~treatment~~conflicts byof usinterest because of their equity interests in or ~~our~~positions ~~CROs;~~with Eureka.

●Our ~~our~~CEO, ~~CROs~~President, orand ~~clinical~~director, ~~study~~Dr. Liu, ~~sites~~currently serves ~~failing~~as tothe ~~comply~~CEO ~~with~~and ~~regulatory~~President ~~requirements~~of orEureka ~~meet~~and ~~their~~

Filing Compare · Estrella Immunopharma, Inc.