10-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

For the fiscal year ended December 31, 2025

Commission file number 001-12830

Lineage Cell Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

2173 Salk Avenue, Suite 200

Carlsbad, California92008

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code (442) 287-8990

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 shares LCTX NYSE American 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 Section 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, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ 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 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 registrant’s voting and non-voting common equity held by non-affiliates of the registrant, based on the closing price of the registrant's common shares on the NYSE American on June 30, 2025, the last business day of the registrant’s most recently completed second fiscal quarter, was $161.5 million.

The number of common shares outstanding as of March 5, 2026 was 249,087,529.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant’s definitive proxy statement relating to its 2026 annual meeting of shareholders are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated.

Lineage Cell Therapeutics, Inc.

Table of Contents

PageNumber

Part I.

Item 1 Business 6

Item 1A Risk Factors 38

Item 1B Unresolved Staff Comments 99

Item 1C Cybersecurity 99

Item 2 Properties 100

Item 3 Legal Proceedings 100

Item 4 Mine Safety Disclosures 100

Part II.

Item 7A Quantitative and Qualitative Disclosures about Market Risk 112

Item 8 Financial Statements and Supplementary Data 113

Item 9A Controls and Procedures 151

Item 9B Other Information 152

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 152

Part III.

Item 10 Directors, Executive Officers, and Corporate Governance 153

Item 11 Executive Compensation 153

Item 14 Principal Accountant Fees and Services 153

Part IV.

Item 15 Exhibits and Financial Statements Schedules 154

PART I

FORWARD-LOOKING STATEMENTS

This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve substantial risks and uncertainties. The forward-looking statements are contained principally in Part I, Item 1. “Business,” Part I, Item 1A. “Risk Factors,” and Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” but are also contained elsewhere in this report. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements in this report include, but are not limited to, statements about:

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the potential to receive developmental, regulatory, and commercialization milestone and royalty payments under our Collaboration and License Agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc.;

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our plans to research, develop and commercialize our product candidates;

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the initiation, progress, success, cost and timing of our clinical trials and other product development activities;

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the therapeutic potential of our product candidates, and the indications for which we intend to develop our product candidates;

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our AlloSCOPETM platform and our ability to successfully manufacture our product candidates for clinical development and, if approved, for commercialization, and the timing and costs of such manufacture;

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the timing and likelihood of regulatory filings and approvals;

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expected regulatory pathways;

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the potential of our cell therapy platform;

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our ability to obtain additional capital to fund our operations;

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the potential that holders of outstanding warrants to purchase our common shares will exercise such warrants on a cash basis;

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our expectations and plans regarding existing and potential future collaborations with third parties such as pharmaceutical and biotechnology companies, government agencies, academic laboratories, and research institutes for the discovery, development, and/or commercialization of novel cell therapy products;

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the size and growth of the potential markets for our product candidates and our ability to serve those markets;

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the potential scope and value of our intellectual property rights; and

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the effects on our operations and workforce and on clinical trials (including those involving OpRegen®) of the ongoing Israeli regional conflict, the escalation of hostilities in the Middle East resulting from the strikes by Israel and the United States on Iran that commenced on February 28, 2026, and broader geopolitical conflicts, political and economic instability, public health emergencies and macroeconomic conditions.

Forward-looking statements reflect our views and expectations as of the date of this report about future events and our future performance and condition, and involve known and unknown risks, uncertainties and other factors that may cause our actual activities, performance, results or condition to be materially different from those expressed or implied by the forward-looking statements. You should refer to Part I, Item 1A. “Risk Factors” of this report for a discussion of important factors that may cause our actual activities, performance, results and condition to differ materially from those expressed or implied by our forward-looking statements. As a result of a variety of factors, including those discussed in Part I, Item 1A. of this report, our forward-looking statements may prove to be inaccurate, and the inaccuracy may be material. Accordingly, you should not place undue reliance on any forward-looking

statement. We anticipate that subsequent events and developments may cause our current views and expectations to change. However, while we may elect to update the forward-looking statements in this report at some point in the future, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date after the date of this report.

You should read this report and the documents that we reference in this report completely and with the understanding that our actual future performance, results and condition may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

This report also contains market data, industry forecasts and other data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.

All brand names or trademarks appearing in this report are the property of their respective owners. Solely for convenience, the trademarks and trade names in this report may be referred to without the symbols ® and TM, but such references should not be construed as any indication that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

Unless otherwise stated or the context requires otherwise, references in this report to “Lineage,” the “Company,” “our company,” “we,” “us,” and “our” refer collectively to Lineage Cell Therapeutics, Inc. and its consolidated subsidiaries.

RISK FACTOR SUMMARY

Below is a summary of the material factors that make an investment in our common shares speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” in Item 1A of Part I of this report and should be carefully considered, together with other information in this report and our other filings with the Securities and Exchange Commission (the “SEC”) before making investment decisions regarding our common shares.

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We are dependent on our third-party collaboration with F. Hoffmann-La Roche Ltd and Genentech, Inc to develop and commercialize RG6501 (OpRegen). If our collaborators are not successful in developing and commercializing OpRegen and/or they terminate the collaboration, we will lose a significant source of potential revenue, development and potential regulatory approval of OpRegen may be significantly delayed, and we may not be successful in establishing an alternative strategic collaboration or pursuing independent development and commercialization of OpRegen.

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Any failure or delay in the successful transfer of manufacturing process know-how by us to Roche or the inability of Roche to manufacture comparable cells could halt or delay the continued development of OpRegen.

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We have incurred operating losses since inception, and we do not know if or when we will attain profitability. We will continue to spend a substantial amount of our capital on research and development, but we might not succeed in developing products and technologies that are safe and effective for their target indications as determined by the U.S. Food & Drug Administration (“FDA”).

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Our investigational allogeneic cell therapies represent a novel approach to the treatment of serious medical conditions, which gives rise to significant challenges. Clinical development of our product candidates is a lengthy and expensive process with a high level of uncertainty as to timing and ultimate outcome. We may not be successful in identifying new product candidates and neither we nor our collaborators may succeed in developing or obtaining regulatory approval to market and sell any of our product candidates.

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Our decisions regarding whether to advance our programs internally or through strategic relationships may not maximize the value of our pipeline for our shareholders, and misjudgments in these decisions could materially adversely affect our business.

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We will need to raise substantial additional capital and capital raising transactions may cause dilution to our existing shareholders, restrict our operations, or require us to relinquish rights to or dilute our economic interest in our product candidates or technology. If we are unable to obtain adequate capital, we may delay, reduce, limit the pace of, suspend or discontinue our product and technology development programs, which could significantly harm our business and prospects and cause the market price of our common shares to decline.

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We may expend our limited resources to identify or pursue particular product candidates and fail to identify other new product candidates or to capitalize on other product candidates that may be more profitable or for which there is a greater likelihood of success.

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If we fail to meet our obligations under our in-license agreements, we may lose our rights to key technologies on which our business depends.

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All of our manufacturing operations currently are conducted by our subsidiary Cell Cure Neurosciences Ltd. (“CCN”) at our facility in Jerusalem, Israel, and the escalation of conflict and hostilities in the Middle East or any other event or condition, such as political and economic conditions in Israel or the broader region, war, cyberattacks, terrorist attacks or other armed conflicts involving Israel and the broader region could harm our business and materially and adversely affect our financial condition and operating results. Further, our operations in Israel expose us to additional business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.

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Our business could be adversely affected if we lose the services of the key personnel upon whom we depend or if we fail to attract and retain senior management and key scientific personnel.

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Taxing authorities could reallocate our taxable income among our subsidiaries, which could increase our overall tax liability.

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Government-imposed bans or restrictions and religious, moral, and ethical concerns about the use of human embryonic stem cells could prevent us from developing and successfully marketing stem cell products.

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Some of our product candidates may be considered combination products by the FDA and other regulatory authorities, which could increase the complexity, cost and timeline for their development and regulatory approval.

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The administration of our cell therapy product candidates requires surgical transplantation, which exposes us to additional regulatory, clinical, operational and commercial risks that could materially adversely affect our business, results of operations and prospects.

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Disruptions at the FDA and other government agencies, including due to a lack of funding, changes in leadership or significant personnel turnover, could delay or disrupt clinical and preclinical development and potential marketing approval of our product candidates and hinder our ability to raise additional capital.

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The results of preclinical studies and early clinical trials are not necessarily predictive of future results.

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Interim, topline and preliminary data from clinical trials of our product candidates that we or our collaborators publicly disclose from time to time may change as more patient data become available and are subject to audit, review and/or verification procedures that could result in final clinical data that is materially different and unfavorable.

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The manufacture of our cell therapy product candidates is complex, highly regulated and subject to a multitude of risks. We have limited experience manufacturing our product candidates on a clinical scale and no experience manufacturing on a commercial scale. Any failure to manufacture our product candidates in sufficient quantities in accordance with applicable quality standards and regulatory requirements and at acceptable costs may result in significant clinical development delays, or impair the ability to obtain approval for or commercialize our product candidates.

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Because developing cell therapy products is based on novel technologies that are unproven and may not result in approvable or marketable products, the lack of success, or perceived lack of success, of other companies developing or seeking to develop cell therapy products may adversely impact investor sentiment regarding our business and the market opportunities for our product candidates.

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Use of our product candidates could be associated with side effects, adverse events, or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials, abandon a product candidate, limit the commercial profile of an approved label, or result in other significant negative consequences that could severely harm our business, financial condition, results of operations, and prospects. In addition, adverse safety events involving other cell therapies, including therapies receiving conditional or time-limited approvals, could increase regulatory scrutiny and negatively affect investor sentiment and the perception of the cell therapy field.

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Changes in or disruptions to the manufacturing operations and processes for our product candidates could significantly delay and increase the costs of clinical development and, and if a product candidate is approved, commercialization.

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The commercial success of any product candidate will depend upon the degree of market acceptance by physicians, patients and third-party payors, and if the market opportunities for our product candidates prove to be significantly smaller than we estimate, our business prospects may suffer.

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We face significant competition and the possibility that our competitors may develop therapies that are more effective, safer, more convenient, or less expensive than our product candidates. In addition, competitive products may be approved and successfully commercialized before ours, which may adversely affect our ability, or that of a strategic collaborator, to successfully commercialize our product candidates.

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We face potential product liability claims, and, if successful claims are brought against us, we may incur substantial liability and costs. If the use or misuse of our products or product candidates harm patients or is perceived to harm patients, our regulatory approvals could be revoked, suspended or otherwise negatively affected, and our reputation could suffer.

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We currently have no marketing and sales force or distribution capabilities.

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Our intellectual property may be insufficient to protect our products and we may become subject to claims of infringement of the intellectual property of others.

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We rely on third parties, including strategic collaborators, clinical research organizations, medical institutions, clinical investigators, consultants, sole source suppliers of specialized materials and equipment, to advance the development of our product candidates and we may encounter significant challenges or delays as a result of our lack of control over those third parties, including increased costs and timelines for production as well as for clinical trials of our product candidates.

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The market price of our common shares has been and may continue to be volatile.

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Our largest shareholder, who is affiliated with a member of our board of directors, owns a significant percentage of our common shares and will be able to exert substantial influence over the election of directors and matters subject to shareholder approval, including potential change of control transactions.

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There is no assurance that we will be able to maintain compliance with the NYSE American’s continued listing standards, and failure to do so could result in the suspension of trading or delisting of our common shares, which could substantially impair our shareholders’ ability to sell their shares and our ability to raise additional capital.

ITEM 1. BUSINESS

Overview

We are a clinical-stage biotechnology company developing cell replacement therapies to treat serious medical conditions. Certain diseases and medical events can arise from the loss of critical cellular activity and lead to devastating or difficult-to-treat conditions or impairments. Our work is grounded in the emerging evidence that replacing or supporting those cells that have become dysfunctional or “lost” (destroyed or dead) can restore or replenish normal function and improve treatment and recovery paradigms. We call this approach “Replace and Restore”. We believe cellular therapies aimed at entirely replacing dysfunctional or destroyed cells may have more durable, broader, or suitable applicability than traditional pharmaceutical products, which often seek to affect just a single molecular target or group of biological pathways. Transplantation of replacement cells represents an emerging branch of medicine, and we believe we are uniquely positioned to capitalize on its opportunities by demonstrating the value of administering mature, differentiated cells to patients. We are developing a portfolio of assets based on this mechanism and our most clinically-advanced program to date is OpRegen (RG6501), an allogeneic retinal pigmented epithelial (RPE) cell replacement therapy currently in Phase 2a development under a worldwide collaboration with F. Hoffman-La Roche Ltd. and Genentech, Inc., a member of the Roche Group (collectively or individually, “Roche” or “Genentech”), for the treatment of geographic atrophy (GA) secondary to dry-AMD.

The cells we have or may seek to manufacture are intended to replace the same type of cells that the patient has lost, or which have become dysfunctional due to various conditions, such as in dry age-related macular degeneration (dry-AMD), spinal cord injury (SCI), hearing loss and Type 1 Diabetes (T1D). We view the term cell transplant as more applicable to our approach than “stem cell therapy”, because we never administer stem cells to patients. Instead, we utilize stem cells solely as a source material, from which to create and deliver partly or fully differentiated (i.e. mature) and functionally active “replacement” cells that are intended to be substantially identical to the cells which have been impacted by disease or trauma. These replacement cells are then transplanted, historically in a one-time procedure, to treat conditions caused by the loss or dysfunction of a specific cell type. Additionally, each of our product candidates is allogeneic and is derived from a single, carefully selected and cultured cell line for the life of the product, which eliminates donor variability and may mitigate certain regulatory and clinical risks.

Our programs are based on our proprietary, in-house, cell-based manufacturing platform, which we call AlloSCOPETM (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), and supported by our associated development, formulation, manufacturing, and delivery capabilities. The AlloSCOPE platform is a proprietary differentiation and production modality from which, i) a single, well-characterized pluripotent cell line can create a stable current Good Manufacturing Practice (cGMP) master cell bank (MCB), ii) a vial from our MCB can create a cGMP working cell bank (WCB), and iii) a vial from our WCB can create several hundred to many thousands of vials of a final, allogeneic cell-based product, ready for patient dosing. This process confers consistent, cost-effective, and scalable cell-based production. Importantly, the AlloSCOPE platform can be applied across multiple programs, which we believe could offer advantages in the pursuit of commercially successful, allogeneic and “off the shelf” cell therapies. In some instances, we also apply a proprietary “thaw-and-inject” formulation into our product profiles, which allows for rapid dosing and “immediate use” of our cells. This formulation technology can greatly reduce the lengthy dose preparation steps often associated with certain cell therapy programs.

Our business strategy aims to efficiently leverage our AlloSCOPE platform and our development and manufacturing expertise to create a pipeline of related but discrete cell-based assets, some of which we may advance internally toward commercialization and some of which we may seek to partner during early or late development, if we believe doing so will enhance their probability of success and value to Lineage and our shareholders . All of our product candidates are based on our core AlloSCOPE platform, and utilize our extensive expertise in the directed differentiation and scalable production of pluripotent cells into discrete cell types of the human body.

The AlloSCOPE Manufacturing Platform

AlloSCOPE, which stands for Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering, is the name we’ve given to our proprietary allogeneic cell manufacturing platform. AlloSCOPE describes a proprietary differentiation and production modality from which we have demonstrated the ability to manufacture allogeneic, cell-based product derived from a single initial cell line, conferring consistent, cost-effective, and scalable cell-based

production. We believe this enables our capability to produce millions of doses of a consistent and cost-effective cell-based product. From our AlloSCOPE platform, we develop, manufacture, and test specialized human cells with anatomical and physiological functions similar or substantially identical to cells found naturally in the human body. The cells we manufacture are produced by applying directed differentiation processes to established, well-characterized, and self-renewing pluripotent cell lines. These processes are based on specific developmental lineages and generate cells with desired characteristics. Functional cells developed from such lineages, and which are relevant to the underlying condition, are transplanted into patients in an effort to (a) replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and (b) restore or enhance the patient’s functional activity in that target tissue.

To date we have successfully completed a current cGMP production run from our two-tiered cell banking system for two of our product candidates. In at least one instance, they have been utilized in a U.S. Food and Drug Administration (FDA) cleared clinical trial in 2025. This demonstrates our ability to scale pluripotent cells with the purity, potency, and regulatory quality required for clinical use, a standard which we believe is currently beyond the reach of many companies, and which can become a valuable competitive differentiator for Lineage.

Pipeline

Our pipeline currently includes:

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OpRegen (designated as RG6501 by Roche and Genentech), an allogeneic RPE cell replacement therapy currently in Phase 2a development under a worldwide collaboration with Roche, for the treatment of GA secondary to dry-AMD.

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OPC1, an allogeneic oligodendrocyte progenitor cell therapy currently in Phase 1/2a development for the treatment of spinal cord injuries (SCI).

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ReSonanceTM (ANP1), an allogeneic auditory neuron progenitor cell transplant therapy currently in preclinical development under collaboration with William Demant Invest 2 Aps (WDI) for the treatment of auditory neuropathy.

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ILT1, an allogeneic cell transplant research initiative focused on addressing the issue of large-scale production of undifferentiated pluripotent cells, which if successful could support the production of islet cells to support a potential treatment of Type 1 Diabetes (T1D).

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RND1, a novel hypoimmune induced pluripotent stem cell line being evaluated under a gene editing partnership with Factor Biosciences Limited (Factor) for the development of a cell transplant candidate for the potential treatment of an undisclosed indication.

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PNC1, an allogeneic photoreceptor cell therapy research initiative for the potential treatment of vision loss due to photoreceptor dysfunction or damage.

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LCT-CON, an undisclosed allogeneic cell transplant research initiative currently receiving internal research & development investment.

Select Business Highlights

We and our partners have achieved numerous clinical, strategic and operational milestones during 2025:

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Reduced-to-practice critical aspects of commercial-scale, cell-based GMP production process (i.e. demonstration of the high-scale production potential from the AlloSCOPE manufacturing platform).

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Successful and ongoing execution of Lineage’s contributions to our worldwide collaboration with Roche and Genentech for the development of OpRegen (RG6501) across multiple functional areas.

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Achieved first milestone available under our collaboration and license agreement with Roche and Genentech based on manufacturing and clinical advancements to the OpRegen (RG6501) program.

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Reported durable improvement in best corrected visual acuity (BCVA) in dry AMD patients who received successful targeted administration of OpRegen (RG6501), as reported from a Phase 1/2a clinical study 36-month visual acuity update at Clinical Trials at the Summit 2025.

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Treated the first-ever chronic SCI patient using a novel delivery device in a clinical study of OPC1 in patients with subacute and chronic SCI.

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Entered into collaboration with WDI to advance the preclinical development ReSonance (ANP1) for sensorineural hearing loss.

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Initiated our ILT1 research program to address the manufacturing scale necessary for a cell transplant therapy to potentially treat T1D

Figure 1. Lineage’s Allogeneic Cell Transplant Pipeline

Business Strategy

The field of cell therapy has revolutionized oncology, saving lives and creating substantial shareholder value. We believe the natural next frontier of value-creation in cell therapy resides in non-oncology indications, such as neurology, ophthalmology, and metabolic diseases. We also believe Lineage is well-positioned to capitalize on this opportunity, mainly by applying our proprietary cell manufacturing technology to the production and transplantation of differentiated cell types.

Lineage is seeking to be a leader in this new branch of medicine. We prefer the term cell transplant to cell therapy because we don’t administer “stem cells” to patients. Instead, we create and deliver mature, differentiated and active “replacement” cells that are substantially functionally identical to the cells which an individual has lost or has become dysfunctional due to disease or trauma. Those cells have been, to date, transplanted in a one-time procedure to treat conditions caused by the loss or dysfunction of a specific cell type. Each of our product candidates is allogeneic and utilizes a single, carefully selected and cultured cell line for the life of the product, which eliminates donor variability and reduces regulatory and clinical risk. Our work is grounded in the conviction that replacing lost or dysfunctional cells can restore function and fundamentally reshape many treatment paradigms.

Our lead program, OpRegen, is being developed under a worldwide collaboration with Roche and Genentech for the treatment of GA secondary to dry-AMD and is currently in a phase 2a clinical study. Our second clinical-stage program, OPC1, is an allogeneic oligodendrocyte progenitor cell therapy designed to improve recovery following a spinal cord injury. One of our preclinical programs, ReSonance (ANP1), is an allogeneic auditory neuron progenitor

cell transplant therapy currently in preclinical development under collaboration with WDI for the treatment of auditory neuropathy. We also recently launched a research initiative focused on addressing the issue of large-scale production of undifferentiated pluripotent cells, which if successful could be evaluated for the production of islet cells to support a potential treatment of T1D, and we have several additional indications being evaluated for future development.

Our core technology, including our AlloSCOPE platform, generates assets which share essential traits in common. Those assets are based foremost on the directed differentiation of pluripotent cells into discrete and scalable cell types of the human body. And while each product candidate is intended for a different condition, and each cell line behaves in a unique manner, the early and necessary steps of process development, namely control, scale, and purity, are largely common features in the way they are applied under the AlloSCOPE platform, which allows us to expand the scope of our pipeline in a focused manner and potentially without requiring an excessive amount of capital investment. Adapting or initiating each program on the same process development modality under the AlloSCOPE platform also may allow us to generate more shots on goal per dollar invested.

Our business strategy is to efficiently leverage our AlloSCOPE platform and our development and manufacturing capabilities to create a pipeline of cell-based assets, some of which we might advance internally and some of which we might seek to partner in order to further enhance their value and probability of success, but all of which rely on our core technology and platform, and which utilize our extensive expertise in the directed differentiation and scalable production of pluripotent cells into discrete cell types of the human body.

Cell Therapy Technology Platform

AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) Platform

We believe we are a leader in pluripotent, cell-based non-oncology product development, as evidenced by our proprietary directed differentiation processes for multiple cellular lineages, cell manufacturing capabilities, corporate alliances, and stage of clinical development across multiple programs.

All our programs are based on our proprietary, cell-based technology platform, AlloSCOPE, which is supported by our development, formulation, manufacturing and delivery capabilities, and serves as the source of our pluripotent cell-based product candidates. Pluripotent cells, which are widely published as capable of becoming any human cell type, have potential applications in many areas of medicine with large unmet patient needs, including certain age-related degenerative diseases, degenerative conditions, or traumatic injury. The AlloSCOPE platform describes in particular a differentiation and production modality, from which we believe we can manufacture millions of doses of an allogeneic, cell-based product derived from a single initial and pluripotent cell line, conferring consistent, cost-effective, and scalable cell-based production. Importantly, the AlloSCOPE platform can be applied across multiple programs and highlights the key attributes of our in-house technology, which we believe are necessary to create a commercially successful, “off the shelf” allogeneic cell therapy.

Our product candidates consist of functional cells that may be able to replace faulty or absent cells, attenuate disease progression, or facilitate tissue repair. Based on our AlloSCOPE platform, we develop, manufacture, and test specialized human cells with anatomical and physiological functions similar or identical to cells found naturally in the human body. The cells we manufacture are produced by applying directed differentiation processes to established, well-characterized, and self-renewing pluripotent cell lines. These processes are based on specific developmental lineages and generate cells with desired characteristics. Functional cells developed from such lineages and which are relevant to the underlying condition are transplanted into patients in an effort to (a) replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and (b) by that restore or enhance the patient's functional activity.

A key advantage of our approach is that we have demonstrated the ability to rapidly develop new programs without the extensive and costly steps traditionally required to develop a small molecule agonist or antagonist. Small molecule product development typically requires selection and validation of a drug target, followed by screening millions of molecules (e.g., a “library”) to identify hits, followed by chemical modification to develop a hit into a potent lead. The process of developing a new cell therapy from pluripotent lines may be comparatively faster in regards to product identification because the target cell type is clearly linked to a condition and may already generally be

“validated”, insofar as it is normally well-established in the literature as being the cell type which is dysfunctional or deficient in the patient and for which its identity and disease-related functional properties can be imitated.

A significant challenge facing the cell therapy field is the ability to create a stable cell product with the purity, control, reproducibility, potency and other vital manufacturing attributes, and to do so at the scale and cost needed to adequately and profitably supply the addressable market population with broad penetration. We believe these features are vital to creating a successful allogeneic cell transplant product.

We believe one of our key advantages is the progress we have made toward demonstrating these capabilities in a cGMP environment and releasing actual production lots for clinical use, which to our knowledge has not been achieved by most of our competitors. To date, we have successfully completed a current cGMP production run from our two-tiered cell banking system for two of our product candidates. In at least one instance, they have been utilized in an FDA cleared clinical trial in 2025. This demonstrates our ability to scale pluripotent cells with the purity, potency, and, regulatory quality required for clinical use, a standard which we believe is currently beyond the reach of many companies, and which can become a valuable competitive differentiator for Lineage.

Figure 2. The AlloSCOPE Platform: Enabling commercially viable, next-generation cell therapies

In addition to our corporate headquarters located in Carlsbad, California, we have a modern and innovative manufacturing facility in the Jerusalem Bio Park on the campus of the Hadassah University Hospital in Israel. That facility includes process development laboratories and a state-of-the-art, cGMP cell manufacturing facility. It is designed and equipped to run simultaneous cGMP processes, and produce a range of cell therapy product candidates for use in clinical trials as well as accommodate scalability for larger trials or potential commercialization. Currently, all of our cGMP manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, are conducted at this facility.

Clinical Stage Cell Transplant Programs

OpRegen Program for Dry-AMD with Geographic Atrophy

Our lead cell therapy program, OpRegen, serves as a critical case study for our approach to cell transplantation. OpRegen (also known as RG6501) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells and is being developed for the treatment of ocular disorders, including GA secondary to dry-AMD under our global Collaboration and License Agreement with Roche entered into in December 2021 (the “Roche Agreement”).

Under the terms of the Roche Agreement, we received a $50.0 million upfront payment in January 2022 and in December 2025, we received the first development milestone for $5 million which was achieved based on manufacturing and clinical advancements related to the OpRegen cell therapy program. We remain eligible to receive as much as an additional $615.0 million in other developmental, regulatory, and commercialization milestone payments in addition to tiered double-digit percentage royalties on net sales of OpRegen in the U.S. and other major markets. Payments received under the Roche Agreement are subject to downstream payment obligations to the IIA and Hadasit. In May 2024, we entered into an additional agreement with Genentech, pursuant to which we agreed to provide Genentech with supplemental clinical, technical, training, manufacturing, and procurement services to support the ongoing advancement of the OpRegen program in exchange for certain payments See “Collaborations—Roche Collaboration Agreement,” below.

Age-Related Macular Degeneration (AMD) Overview and Treatments

AMD is a gradual, progressive, deterioration of the macula, the small sensitive area in the center of the retina that provides clear, high-definition central vision. It is a leading cause of vision loss in people over the age of 65 in the developed world. According to a 2022 report in JAMA Ophthalmology, 18.34 million individuals in the U.S. 40 years and older (11.64%) were living with early-stage AMD and 1.49 million (0.94%) were living with late-stage AMD in 2019. As the area of atrophy begins to include the fovea (the center of the macula), patients may lose their central vision, making facial recognition, reading, and driving difficult or impossible, and may ultimately become legally blind. The exact cause of GA secondary to AMD is unknown, but is thought to result from multiple factors, such as genetics, age, smoking history, and environmental effects.

There are two clinical presentations of AMD, the dry form, and the wet, or neovascular form (growth of abnormal new blood vessels). Dry AMD typically advances slowly toward GA as RPE cells and photoreceptors become dysfunctional and deteriorate over time. RPE cells support and nourish the retina by metabolizing waste by-products and producing a number of components essential for photoreceptor health and function. If the metabolic waste products accumulate, lesions known as drusen may result.

Approximately 85-90% of AMD patients suffer from the dry form of AMD, for which there are only two FDA approved therapeutic options at this time, pegcetacoplan injection (SYFOVRE®) and avacincaptad pegol intravitreal solution (IZERVAYTM). Both approved products are complement inhibitors, administered either monthly or every other month, and neither has clinically demonstrated improved or restored vision to date, which means patients are likely to experience gradual continued vision decline while on treatment.

Physicians often recommend a healthy diet, exercise and/or nutritional supplements for dry AMD, but nutritional supplements have shown limited efficacy in delaying the onset of more progressive disease in longer-term studies. The schematics in Figures 3 and 4 show a representation of the process of drusen formation and the goal of cell replacement therapy.

Mechanism of Action

Our approach, which we believe is one of the most promising options to treat GA secondary to dry AMD, is to replace the layer of damaged RPE cells with new, healthy, and functional RPE cells manufactured from a well-characterized, allogeneic cell line, transplanted to the subretinal space, and extensively cover the area of geographic atrophy.

OpRegen is a cell replacement therapy derived from our AlloSCOPE manufacturing platform in which our proprietary directed-differentiation methods convert pluripotent stem cells into nearly pure populations of RPE cells. Using this method, OpRegen is grown free of any animal products and consists of human RPE cells with high yield and purity that can be transplanted directly into the patient’s eye, where the patient’s own RPE cells are missing or dysfunctional.

The goal of the OpRegen therapeutic approach is to slow or halt disease progression and to preserve and/or restore visual function in patients affected by dry-AMD. OpRegen has been granted Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA, which includes an expedited regulatory path with the ability for increased interfacing with the FDA during the clinical development process.

OpRegen is intended to be an allogeneic, or “off-the-shelf,” product provided to retinal surgeons, prepared in a ready-to-use “thaw-and-inject” form for transplantation. We believe OpRegen could have a lasting benefit from a single administration or administered every several years. This approach differs from the two FDA-approved drugs for treatment of GA secondary to AMD, pegcetacoplan injection (SYFOVRE®) and avacincaptad pegol intravitreal solution (IZERVAYTM), and approved agents currently marketed for wet AMD, such as ranibizumab (Lucentis®) and aflibercept (Eylea®). All of these approaches require repeated, frequent (monthly or every-other-month) intravitreal injections into the eye.

Clinical Data and Development

Phase 1/2a Clinical Study Overview

In a Phase 1/2a clinical trial, OpRegen has demonstrated the potential to slow, stop or reverse disease progression in GA secondary to AMD and these results, which were present at 12 months, have persisted through 24 and 36 months following a single administration of OpRegen.

In this open-label, single-arm, multicenter, dose-escalation trial evaluating a single administration of OpRegen, the investigational product was delivered subretinally in patients with bilateral GA. Patient enrollment completed in November 2020, with twenty-four patients recruited into four cohorts. The first three cohorts enrolled only legally blind patients with a best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 patients with impaired vision (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which could be shipped directly to sites and used immediately upon thawing. The primary objective of the study was to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment-emergent adverse events. Secondary objectives evaluated the preliminary activity of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Long-term follow-up of patients in this study is currently ongoing.

In June 2025, 36-month visual acuity results from patients enrolled in the Phase 1/2a clinical trial were presented by Roche and Genentech. Highlights include:

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Improvement in visual acuity in patients in Cohort 4 (less advanced GA than in other cohorts) present at 12 months (primary endpoint), 24 months, and persisted through 36 months.

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Gains in BCVA in patients in Cohort 4 (less advanced GA) measured at month 12 remain evident through month 36 following subretinal administration of OpRegen cell therapy.

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Mean change in BCVA among treated eyes for patients (n=10) completing 3-year follow up was +6.2 letters (compared to +5.5 letters at 24 months) (Early Treatment Diabetic Retinopathy Study (ETDRS) assessment).

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Improvement in BCVA and outer retinal structure in patients with extensive OpRegen bleb coverage of their GA area was greater than in patients with limited coverage and persisted through month 36.

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Effects were greater on average in the five (5) patients with extensive OpRegen cell therapy coverage of atrophic areas at the time of surgical delivery.

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Sustained evidence of retinal structural improvement by a quantitative Optical Coherence Tomography (OCT) analysis through 36 months was observed in treated eyes of Cohort 4 patients (less advanced GA than in other cohorts) following a single subretinal administration of OpRegen cell therapy.

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At month 36, sustained evidence of retinal structure improvements in external limiting membrane (ELM) and RPE drusen complex (RPEDC) layers on OCT was observed in the subgroup of five patients in Cohort 4 with extensive OpRegen cell therapy bleb coverage of atrophic areas at the time of surgical delivery.

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These data suggest that OpRegen cell therapy may counteract RPE cell dysfunction and loss in GA by providing support to the remaining retinal cells within atrophic areas, and these effects appear durable through at least 36 months after a single administration.

Phase 2a Clinical Study (“GAlette”) Overview

OpRegen is currently being evaluated by our partners Roche and Genentech in a Phase 2a multicenter clinical trial in patients with GA secondary to dry-AMD, the “GAlette” study, which is currently enrolling up to 60 patients at 17 clinical sites across the U.S. and Israel.

The study is intended to optimize subretinal surgical delivery and evaluate biological activity of OpRegen in up to 60 patients with GA secondary to dry-AMD. The primary objectives of the study are to evaluate (i) the success of subretinal surgical delivery of OpRegen as measured by the proportion of patients with subretinal surgical delivery of OpRegen to target regions under the retina, and (ii) the safety of subretinal surgical delivery of OpRegen as measured by the incidence and severity of procedure-related adverse events at 3 months following surgery. The secondary objective is to evaluate the biological activity of OpRegen measured by the proportion of patients with qualitative improvement in retinal structure, as determined by Optical Coherence Tomography (SD-OCT) imaging, within 3 months following surgery. Genentech currently plans to also evaluate two proprietary surgical delivery devices that have potential advantages over available off-the-shelf devices in the ongoing GAlette study.

OPC1 Program for Spinal Cord Injury

Our most advanced, internally owned product candidate is OPC1, an allogeneic oligodendrocyte progenitor cell therapy designed to improve recovery following a spinal cord injury. Improved functional activity can lead to greater mobility and enhanced quality of life for those affected by a SCI and significant cost-savings for caregivers and payors. Importantly, elevations in functional improvement can be reasonably expected to be retained for long periods, including the lifetime of the patient, enhancing the value of any gains of function that are achieved by a patient. OPC1 is currently being tested in a phase 1 safety study of a novel delivery device, and in parallel, we are working on the design of a larger comparative clinical study.

OPC1 has an extensive long-term safety profile based on two clinical trials conducted to date. See “—Clinical Data and Development—Phase 1 Thoracic Study and Phase 1/2a Cervical Study,” below.

OPC1 has received RMAT designation and Orphan Drug designation from the FDA.

Spinal Cord Injury (SCI) Overview

SCI occurs when the spinal cord is subjected to a severe crush or contusion injury, such as that caused by a car or motorcycle accident, and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder and/or sexual function.

There are approximately 18,000 new spinal cord injuries annually in the U.S. (NSCIC SCI Facts and Figures at a Glance (2025)), and there are currently no FDA-approved drugs specifically for the treatment of SCI, although methylprednisolone, a corticosteroid generally used as an anti-inflammatory drug, is sometimes prescribed on an off-label basis to reduce acute inflammation in the injured spinal cord immediately after injury.

Approaches to treat this complex injury may include multiple mechanisms of action, such as biologics that preserve surviving neurons and stimulate new nerve axon outgrowth, suppression of lesion cavity formation at the injury site, generation of new blood vessels to repair the ischemic damage from injury, and myelination of the demyelinated and newly formed nerve axons.

A potential therapeutic target in SCI is replacement of oligodendrocytes that are selectively lost at the injury site. As the sole source of the insulating protein myelin in the brain and spinal cord, oligodendrocytes wrap around nerve axons and allow the conduction of electrical impulses throughout the CNS, as shown in Figure 5.

Figure 5. Oligodendrocytes are the myelinating cells of the CNS and are critical for nerve signal conduction.

Mechanism of Action

OPC1 is derived from our pluripotent cell technology under cGMP conditions using a directed differentiation method. These cells are stored frozen until ready for use and prepared for direct administration into the injured spinal cord after thawing. Based on preclinical studies, when OPC1 is transplanted into the injured spinal cord, the cells undergo further maturation to generate a replacement population of oligodendrocytes at the injury site that are capable of remyelinating denuded and newly formed nerve axons.

Based on preclinical studies, prior to their maturation, the transplanted oligodendrocyte progenitor cells are believed to stimulate additional reparative processes, including promotion of neuron survival and nerve axon outgrowth, and induction of blood vessel formation in and around the injury site. In addition, OPC1 cells can migrate from the injection point to the injury site where they generate a supportive tissue matrix and suppress cavitation (Figure 6). Cavitation is a destructive process that occurs within the spinal cord following SCI, and typically results in permanent loss of motor and sensory function. A patient with cavitation can develop a condition known as syringomyelia, which results in additional neurological and functional damage to the patient and can result in chronic pain. Based on the multiple reparative properties associated with OPC1, we believe this candidate cell therapy product is ideally suited to treat neurological conditions such as SCI and other demyelination disorders of the CNS.

Figure 6. Suppression of spinal cavitation in a rat contusion model

Clinical Data and Development

Phase 1 Thoracic Study and Phase 1/2a Cervical Study

To date, two clinical trials of OPC1 have been completed: a Phase 1 clinical safety trial in 5 patients with thoracic SCI, where all active participants have been followed for at least 14 years, and a Phase 1/2a multicenter dose-escalation clinical trial in 25 patients with cervical SCI, where all active participants were evaluated for at least 8 years.

Results from both studies have been published in the Journal of Neurosurgery Spine. Key findings from these clinical studies are summarized in Figure 7.

Figure 7. OPC1 Thoracic & Cervical Clinical Trials Overview

DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) Clinical Study

In February 2025, we announced that we were initiating our “DOSED” clinical study to evaluate the safety and utility of a novel spinal cord delivery device designed to administer OPC1 to the spinal parenchyma in both subacute (between 21 to 42 days following injury) and chronic (between 1 to 5 years following injury) spinal cord injury. The DOSED study is the first study of OPC1 to include participants with a chronic injury, a condition which comprises most individuals affected by SCI. If the novel delivery system is determined to be satisfactory for its purpose, we expect the device will enable future studies which will aim to demonstrate OPC1’s ability to impact functional outcomes.

In July 2025, the first chronic SCI participant, with a neurologically complete SCI injury was treated in the DOSED study at UC San Diego Health, and the novel delivery system successfully administered a one-time injection of OPC1. No significant safety events have been reported through 180 days post treatment in the first treated chronic SCI participant in the DOSED study.

In February 2026, our second clinical site in the DOSED study, Rancho Research Institute, in conjunction with Rancho Los Amigos National Rehabilitation Center, opened for enrollment.

Manufacturing and Delivery Improvements

All cGMP manufacturing processes, including the establishment of cell banks and the production of OPC1, are conducted at CCN, our subsidiary and manufacturing site. Improvements to the OPC1 starting material and manufacturing process were completed at CCN, leading to significant increases in scale and purity. CCN also

developed a ready-to-use thaw-and-inject formulation of OPC1, which simplifies logistics and handling at the point of care and eliminates dose preparation at the clinical site. We have also manufactured clinical batches based on the improved process in a thaw-and-inject formulation in preparation for any larger-scale clinical trials we may conduct.

In February 2021, we announced an exclusive agreement with Neurgain Technologies, Inc. (“Neurgain”), to evaluate a novel delivery system for OPC1. Preliminary assessment of prototypes revealed promising compatibility with OPC1 product while simplifying the surgical procedure by providing surgeons with an instrument that is small, simple to use, and would not require stopping the patient’s ventilator to perform the injection, allowing for flexibility with accurate delivery to the injury site. We continue to evaluate the Neurgain device, including in the DOSED Study.

Preclinical and Research Cell Transplant Programs

ReSonance Program for Hearing Loss

Our second most advanced internally owned product candidate is ReSonance (ANP1), an allogeneic auditory neuron progenitor cell transplant, currently in preclinical development for the treatment of sensorineural hearing loss.

In August 2025, we announced that we entered into a research collaboration agreement with William Demant Invest 2 Aps (“WDI”) to advance the preclinical development of ReSonance for the treatment of hearing loss. WDI will fund up to $12 million in planned research collaboration costs over the approximate three-year term of the agreement.

The main objective of the agreement is for the parties to complete a preclinical development plan leading to readiness to progress to human clinical trials under one or more separate clinical agreements, the terms of which would be negotiated in good faith before the expiration of the agreement. Development activities will be jointly conducted and managed by Lineage and scientists from Eriksholm Research Centre, part of Oticon A/S, which is a subsidiary of the Demant Group. See Note 13 (Commitments and Contingencies) to our consolidated financial statements included in this report for additional information.

Islet Cell Transplant Research Initiative

In September 2025, we announced the launch of a new cell therapy research initiative focused on addressing the issue of large-scale production of undifferentiated pluripotent cells, which if successful could support the production of islet cells to support a potential treatment of Type 1 Diabetes (T1D).

We believe there are three areas of emphasis for a cell transplantation that could lead to a commercially feasible, functional cure for T1D patients. The first area, mechanism of action, has already been demonstrated, with multiple independent reports showing that an islet cell transplant from cadaveric or pluripotent cell sources can achieve insulin independence for diabetics. The second area is the reduction or prevention of immunological rejection of transplanted cells, as lifetime immunosuppression is not a feasible solution for most patients. Multiple attempts to eliminate the need for immunosuppression have been explored, such as encapsulation, but recent evidence from genetically edited “hypoimmune” cells may offer a successful approach. The third area is the production scale required for a commercially viable cell therapy for T1D patients. Cadavers are not a sustainable or consistent source of islet cells, but pluripotent cells are self-renewing, so they may be able to address the scale deficiencies. Since the current anticipated dose levels of a cell therapy transplant for T1D patients may be as high as a billion cells per patient, a large-scale production process will be required to address the issue of commercially viable production of islet cells.

Under our T1D cell therapy research initiative, we plan to deploy our AlloSCOPE manufacturing capabilities to address the issue of large-scale production of undifferentiated pluripotent cells, with the initial goal of establishing a production modality that can support the entire production process through differentiation in a dynamic culturing system, which if successful, could potentially solve a major hurdle to commercialization of eventual islet cell therapy product candidates.

An initial objective for this initiative is to demonstrate a scalable process for undifferentiated pluripotent cells using one of our proprietary and in house cell lines. This initial work has been successful at a small scale (0.5 liter) and supports further development into a larger scale. If successful at larger scale, we may thereafter seek to

demonstrate AlloSCOPE platform scalability with an internally or externally sourced, hypo-immune cell line, one suitable to support eventual islet cell differentiation for a potential clinical campaign in T1D, or we may proceed with a larger or optimized process with our non hypoimmune line. Importantly, we expect we can apply insights and process improvements we have learned or will learn through this process to our other cell transplant programs, including programs we may launch in the future.

Overall, if we are successful in developing a commercially viable production modality for undifferentiated pluripotent cells, and we then differentiate those into islet cells, we believe it will create a compelling product profile, as well as provide options to license this technology to a partner or enter the diabetes field directly.

RND1 Research Initiative

RND1 is a novel hypoimmune iPSC cell line being evaluated in collaboration with our gene editing partner Factor Biosciences for the development of a cell transplant candidate for the potential treatment of an undisclosed indication.

In February 2023, we entered into an option and license agreement with Factor (as assigned from Eterna) to develop engineered hypoimmune iPSC line that we will evaluate for differentiation into cell transplant product candidates for CNS diseases and certain indications, including RND1. In September 2023, we announced the initiation of certain development activities to generate a novel iPSC line with Factor and our selection of specific gene edits for the initial product candidate to be developed by Factor. The edits include: the targeted deletion of the B2M gene, designed to reduce the immunogenicity of product candidates derived from the lines by inhibiting rejection by CD8+ T cells; the targeted insertion of the HLA-E gene, designed to overexpress HLA-E and prevent the allogeneic NK cell response; and a third undisclosed edit intended to confer clinical differentiation and a competitive advantage in the applicable indications. We expect that these edits may expand the edited cell lines’ overall utility, including for non-immune privileged or non-human leukocyte antigen (HLA) matched indications and may further differentiate the cell line from others currently in use by competitors.

In January 2026, we announced the receipt of the novel iPSC line with Factor. Acceptance of the line triggered a success payment from Lineage to Factor as reimbursement for Factor’s development efforts. Factor remains eligible for an additional payment from Lineage subject to Lineage’s entry into an exclusive license to utilize the line. Lineage’s decision to proceed with the RND1 program will be based on further performance criteria and the outcome of additional testing, including the evaluation of the novel cell line for its ability to adapt to Lineage’s AlloSCOPE platform.

We believe this collaboration allows us to leverage our expertise by capitalizing our directed cell differentiation and manufacturing capabilities with externally-sourced gene editing technology. This is reflective of a portion of our corporate strategy which aims to capitalize on our process development capabilities by combining them with cell engineering and editing technologies to produce novel cell therapies with potentially superior product profiles compared to currently marketed therapies, if any.

PNC1 Research Initiative

Our photoreceptor research initiative, PNC1, is focused on a process of directing the differentiation of human pluripotent cells into clinical-grade transplantable photoreceptor precursors/cells and to show their further differentiation, integration, and function after transplantation into the subretinal space of animal models of photoreceptor degeneration. Photoreceptor degeneration is the hallmark of a variety of retinal diseases such as retinitis pigmentosa (RP). Currently, the only approved treatments for RP are gene therapies which treat specific genetic defects that lead to RP. Our PNC1 program aims to replace damaged photoreceptors regardless of the cause of degeneration.

Other Programs and Technologies

The pluripotent cells underlying our platform are by definition, capable of becoming any cell type of the human body. We therefore maintain a list of additional potential product candidates which we may consider for

development or partnership in the future, and which altogether cover a range of therapeutic areas and conditions. Generally, we expect that these potential product candidates will be based on the same AlloSCOPE platform technology and would employ a similar guided cell differentiation and transplant approach as our current product candidates, and in some cases may also include genetic modifications designed to enhance efficacy and/or safety profiles. We currently have more than one additional undisclosed cell type receiving initial research & development and/or business development internal resources, and we expect to share updates on one or more of these new initiatives during 2026. We also may elect not to develop, terminate the development of, or not partner any of these product candidates.

Collaborations

In addition to seeking to create value for shareholders by developing product candidates through clinical development, we also may seek to create value from our intellectual property or related technologies and capabilities, through licensing collaborations and/or other strategic transactions. Generally, these product candidates are based on the same pluripotent platform technology and would employ a similar guided cell differentiation and transplant approach as our current clinical-stage products.

To accelerate the discovery and advancement of transplanting specific cell types into the body, we have entered into, and intend to seek additional opportunities to form, collaborations with a diverse group of strategic partners. We have entered into collaborations with pharmaceutical and biotechnology companies, government agencies, academic laboratories, and research institutes with resources and expertise in diverse areas.

Roche Collaboration Agreement

On December 17, 2021, Lineage entered into the Roche Agreement, pursuant to which Lineage granted to Roche exclusive worldwide rights to develop and commercialize RPE cell therapies, including its proprietary cell therapy known as OpRegen, for the treatment of ocular disorders, including advanced dry AMD with GA.

Under the terms of the Roche Agreement, Roche assumed responsibility for further clinical development and commercialization of OpRegen and Lineage is responsible for completing activities related to the ongoing clinical study Phase 1/2a open-label, dose-escalation clinical safety and efficacy study in patients with advanced dry AMD with GA, for which enrollment is complete, and performing certain manufacturing and process development activities.

Roche paid Lineage a $50.0 million upfront payment (which was received in January 2022) and another $5.0 million milestone payment (which was received in December 2025). Lineage is eligible to receive up to an additional $615.0 million in developmental, regulatory and commercialization milestone payments. Lineage is also eligible for tiered double-digit percentage royalties on net sales of OpRegen. All milestone payments, and royalty payments, due under the Roche Agreement are subject to the existence of certain intellectual property rights that cover OpRegen at the time such payments would otherwise become due, and the royalties on net sales of OpRegen are subject to financial offsets based on the existence of competing products.

Unless earlier terminated by either party, the Roche Agreement will expire on a product-by-product and country-by-country basis upon the expiration of all of Roche’s payment obligations under the Roche Agreement. Roche may terminate the Roche Agreement in its entirety, or on a product-by-product or country-by-country basis, at any time with advanced written notice. Either party may terminate the Roche Agreement in its entirety with written notice for the other party’s material breach if such party fails to cure the breach. Either party also may terminate the Roche Agreement in its entirety upon certain insolvency events involving the other party.

Based on the intercompany relationship between Lineage and CCN, Lineage is responsible for payment to the IIA (as defined below) approximately 24.1% of the upfront payment and of any future payments Lineage receives under the Roche Agreement, up to an aggregate cap on all payments to IIA, such cap growing over time via interest accrual until paid in full. As of December 31, 2025, the aggregate cap amount was $96.2 million. In addition, pursuant to the Second Amended and Restated License Agreement, dated June 15, 2017, CCN, and Hadasit Medical Research and Development Ltd. (“Hadasit”), as amended, and a letter agreement entered into between CCN and Hadasit on December 17, 2021, Lineage is responsible for payment to Hadasit (i) a maximum of 21.5% of the upfront payment (subject to certain reductions) and of any milestone payments Lineage receives from Roche under the Roche

Agreement, and (ii) up to 50% of all royalty payments (subject to a maximum payment of 5% of net sales of products) Lineage receives from Roche under the Roche Agreement. In accordance with the foregoing obligations, from the $50.0 million upfront payment Lineage received from Roche in January 2022, Lineage paid $12.1 million to the IIA and $8.9 million to Hadasit, and from the $5.0 million milestone payment Lineage received from Roche in December 2025, Lineage paid $1.2 million to the IIA and accrued $1.1 million payable to Hadasit. See “Grants from Government Entities,” below, and Note 13 (Commitments and Contingencies) to our consolidated financial statements included in this report for additional information related to our obligations to the IIA and Hadasit.

In May 2024 we established a new Services Agreement with Genentech, a member of the Roche Group, to support ongoing development of OpRegen. Under this new agreement, Lineage agreed to provide additional clinical, technical, training and manufacturing services that further support the ongoing advancement and optimization of the OpRegen program. These additional services will be primarily funded by Genentech and include: (i) activities to support the ongoing Phase 1/2a study and currently-enrolling Phase 2a study; and (ii) additional technical training and materials related to Lineage’s cell therapy technology platform to support commercial manufacturing strategies.

Second Amendment to Clinical Trial and Option Agreement and License Agreement with Cancer Research UK

In May 2020, Lineage and Asterias entered into a Second Amendment to the Clinical Trial and Option Agreement (the “Second CTOA Amendment”) with CRUK and Cancer Research Technology (“CRT”). Pursuant to the Second CTOA Amendment, Lineage assumed all obligations of Asterias and exercised early its option to acquire data generated in the Phase 1 clinical trial of VAC2 in non-small cell lung cancer being conducted by CRUK. Lineage and CRT effectuated the option by simultaneously entering into a license agreement (the “CRT License Agreement”).

Effective June 30, 2025, Lineage elected to cease development and commercialization of all products under the CRT License Agreement. Upon notice, and in conjunction therewith, CRT notified Lineage of CRT’s termination of the CRT License Agreement. Further, Lineage notified Immunomic Therapeutics, Inc. (“ITI”) of the termination of the collaboration agreement that Lineage had entered into with ITI in April 2021 (the “ITI Agreement”) in accordance with its terms. As of June 30, 2025, the Company has abandoned all future development efforts and will no longer prosecute any of the pending patent applications or issued patents related to the VAC platform. See Note 6 (Goodwill and Intangible Assets, Net) to our consolidated financial statements included in this report for additional information.

William Demant Invest Collaboration Agreement

On August 22, 2025, Lineage and WDI entered into a research collaboration agreement (the RCA) to advance the preclinical development of ReSonance (ANP1) for the treatment of hearing loss (the Project). WDI will fund up to $12 million in planned research collaboration costs over the approximate three-year term of the RCA. The main objective of the RCA is for the parties to complete a preclinical phase achieving readiness to potentially progress to human clinical trials under one or more separate clinical agreements, the terms of which would be negotiated in good faith before the expiration of the RCA.

All intellectual property owned by a party prior to the date of the RCA will remain such party’s sole and exclusive property. The parties will jointly own all results, data, reports, know-how and patent(s) conceived or otherwise generated in the course of and resulting from the Project, other than discoveries or developments relating to Lineage’s proprietary platform technology.

If a party (the “abandoning party”) informs the other party (the “continuing party”) that it will not continue the research with the other party under a clinical agreement, the continuing party may purchase the abandoning party’s ownership interest in the intellectual property resulting from the Project for exploitation for the treatment of hearing loss and a license to the abandoning party’s background intellectual property to the extent necessary for such exploitation for an amount and on terms to be determined by the mutual agreement of the parties, and if such mutual agreement is not reached, by an independent third-party.

Grants from Government Entities

Grants from the Israeli Innovation Authority

Under the Israeli Encouragement of Research, Development and Industrial Initiative Technology Law, 5744-1984, as amended, and related regulations (collectively, the “Innovation Law”), research and development programs which meet specified criteria and are approved by the Israel Innovation Authority (the “IIA”) are eligible for grants of up to 50% of the project’s expenditure, as determined by the research committee, in exchange for the payment of royalties from the revenues generated from the sale of product candidates and related services developed, in whole or in part pursuant to, or as a result of, a research and development program funded by the IIA. The royalties are generally at a range of 3.0% to 5.0% of revenues until the entire IIA grant is repaid, together with an annual interest generally tied to an interest rate index.

Under the Innovation Law, the manufacture of product candidates developed with government grants is required to be performed in Israel. The transfer of manufacturing activity outside Israel may be subject to the prior approval of the IIA, and if approved, may increase the royalties payable to the IIA, in certain cases substantially. The amount of the increase in the royalties payable depends on the percentage of manufacturing activity that occurs outside Israel.

The know-how developed within the framework of the Innovation Law plan may not be transferred to third parties outside Israel without the prior approval of a governmental committee chartered under the Innovation Law. The IIA approval to transfer know-how created, in whole or in part, in connection with an IIA-funded project to a third party outside Israel where the transferring company remains an operating Israeli entity is subject to payment of a redemption fee to the IIA calculated according to a formula provided under the Innovation Law that is based, in general, on the ratio between the aggregate IIA grants to the company’s aggregate investments in the project that was funded by these IIA grants, multiplied by the transaction consideration. The transfer of such know-how to a party outside Israel where the transferring company ceases to exist as an Israeli entity is subject to a redemption fee. The redemption fee in case of transfer of know-how to a party outside Israel is generally based on the ratio between the aggregate IIA grants received by the transferring company and the transferring company’s aggregate research and development expenses, multiplied by the transaction consideration. The maximum amount payable to the IIA in case of transfer of know-how outside Israel will not exceed six times the value of the grants received plus interest. In the event that the grant recipient ceases to be an Israeli corporation such payment shall not exceed six times the value of the grants received plus interest, with a possibility to reduce such payment to up to three times the value of the grants received plus interest if the research and development activity remains in Israel for a period of three years after payment to the IIA.

The restrictions under the Innovation Law, including restrictions on the sale, transfer or licensing to a non-Israeli entity of know-how developed as part of the programs under which the grants were given, continue to apply even after the repayment of royalties in full by the grant recipient.

Part of CCN’s research and development efforts have been financed, partially, through grants that it has received from the IIA and when we acquired our holdings in CCN, we undertook in writing, vis-à-vis the IIA, to comply with, and to ensure the compliance by CCN with, the Innovation Law. To date, through a series of separate grants beginning in 2007, CCN received a total of $15.4 million from the IIA to support the OpRegen program. See Note 13 (Commitments and Contingencies) to our consolidated financial statements included in this report for additional information.

Grants from the California Institute for Regenerative Medicine

The clinical development of OPC1 was supported in part by $14.3 million from CIRM, a state agency established to fund stem cell research and development of new stem cell-based treatments. The terms of our grant award from CIRM include royalty payments to the California State General Fund based on net commercial revenue from the sale of any product, drug or service arising from CIRM-funded research as follows: 0.1% per $1.0 million of funds granted for the earlier of 10 years or nine times the award amount that has been paid. In addition, a 1% royalty will be owed on net commercial revenue in excess of $500 million per year until the last to expire patent covering a CIRM-funded invention, if any, contributed towards the commercialization of the product.

In June 2025 we applied for a Clinical Trial (CLIN2) award (the “CIRM Grant”) from CIRM for approximately $7.0 million to support continued clinical development of OPC1 for the treatment of SCI. On November 28, 2025, the Company elected to withdraw its application for the CIRM Grant following comments to the application received by the Company from CIRM. Following discussions between the Company and CIRM representatives, on January 28, 2026, the Company submitted a revised application to address the feedback it received on its original application. Neither the withdrawal of the Company’s current application nor the planned resubmission of a revised application impact the Company’s current and planned development of OPC1 or the ongoing DOSED clinical study. No assurances can be given that Lineage will be awarded a grant or, if awarded, the amount or timing thereof.

Intellectual Property

We seek to protect and rely on our proprietary cell-based therapy platform technologies and associated development and manufacturing capabilities and derived product candidates and products with intellectual property through a variety of measures, including seeking and maintaining patents intended to cover our products, including compositions, their methods of use and processes for their manufacture, our platform technologies and any other inventions that are commercially important to the development of our business and, when appropriate, trade secret protection. We have sought, and intend to continue to seek, appropriate patent protection for important and strategic components of our proprietary technologies by filing patent applications in the United States and internationally. We may also file additional patent applications, when appropriate, to cover improvements on our manufacturing processes, clinical products, clinical product candidates, and related technologies. From time to time, we assess our patents and pending applications covering our products and product candidates. If we determine that any patents or patent applications no longer provide adequate or necessary protection, we may assign or abandon such patents and patent applications to avoid incurring unnecessary costs.

To further protect our proprietary confidential information, know-how, and trade secrets, we require confidentiality agreements with our employees, consultants, vendors, collaborators and similar third parties. For example, we require our employees and consultants to execute confidentiality and invention assignment agreements upon accepting employment or entering into other relationships with us. We also implement internal policies and procedures to ensure protection of our proprietary confidential information including know-how and trade secrets through, for example, limited and restricted confidential access to this information.

There are no assurances that any of our intellectual property rights will guarantee complete or adequate protection or market exclusivity for our products and product candidates. We also enter into collaborative and other similar contractual arrangements with third parties, such as license agreements, to in-license and/or out-license intellectual property rights. Our financial success will be dependent, in part, on our ability to obtain rights to commercially valuable patents and other intellectual property, to protect and enforce our intellectual property rights and to operate without knowingly infringing any intellectual property rights of others.

We own or license, directly or through our subsidiaries, patent families that include several hundred U.S. and international patents and patent applications. We cannot be certain that issued patents will be enforceable or provide adequate protection or that pending patent applications will result in issued patents.

OpRegen

We solely own and have rights to U.S. and international issued patents and pending patent applications relating to OpRegen, including those in-licensed from Hadasit. Our solely owned issued patents and pending patent applications include those relating to a cryopreserved thaw-and-inject formulation which have, or if issued, will have estimated patent expiration dates in 2038. Otherissued patents and pending patent applications, if issued, have expiration dates ranging from 2028 to 2042. Pursuant to the Roche Agreement, we have licensed these patent rights to Roche to further develop and commercialize RPE cell therapies, including OpRegen (see “—Collaborations—Roche Collaboration Agreement” above).

OPC1

We own numerous U.S. and international issued patents and pending patent applications that are relevant to neural cells, such as oligodendrocyte progenitor cells, that are directed to the differentiation of pluripotent stem cells, including human embryonic stem (“hES”) cells, into various neural cell types, as well as various culture and

purification methods. These issued patents and pending patent applications include eight patent families directed to improved methods of producing oligodendrocyte progenitor cells, oligodendrocyte progenitor cell compositions, and methods of treatment of spinal cord injury using oligodendrocyte progenitor cells. These patent families include five U.S. patents directed to methods for producing oligodendrocyte progenitor cells, composition of oligodendrocyte progenitor cells and methods of treatment of spinal cord injury using oligodendrocyte progenitor cells. The estimated patent expiration dates of these nine patent families range from 2036 to 2045. The commercial success of OPC1 depends, in part, upon our ability to exclude competition for this product with the existing patent portfolio and new patent applications that may be filed, regulatory exclusivity, undisclosed know-how and/or trade secrets, or a combination of these exclusivity barriers to entry.

Auditory Neurons

We have ten pending patent applications for our ANP1 program which include one pending U.S. provisional patent application and a pending U.S. utility patent application, six pending international patent applications and a PCT patent application. The pending U.S. utility patent application and the pending international applications if issued would have estimated patent expiration dates in 2043. It is anticipated that the pending provisional patent application will be converted to a PCT patent application in 2026. It is anticipated that the pending PCT patent application will be converted to a U.S. utility patent application and one or more international patent applications in 2026 and, if issued, would have estimated patent expiration dates in 2045.

Photoreceptors

We have rights to two patent families for our PNC1 program. These patent families include issued U.S. and international patents and pending patent applications. One of these patent families is owned by us and includes U.S. and international pending patent applications and issued patents with estimated patent expiration dates in 2036. The other patent family is jointly owned by us and Hadasit resulting from the collaborative efforts of Hadasit and CCN pursuant to the photoreceptor development program under the Second Amended and Restated License Agreement between Hadasit and CCN. This jointly owned patent family includes a pending U.S. utility patent application and six international patent applications and, if issued, would have estimated patent expiration dates in 2043. We removed the photoreceptor development program from the scope of that license agreement in April 2024, and the pending U.S. and international patent applications will continue to be jointly owned by us and Hadasit.

General Risks Related to Obtaining and Enforcing Patent Protection

Because patent applications are confidential until a patent application is published or a patent is issued, we may not know if our competitors have filed patent applications for technology covered by our pending applications or if we were the first to invent or first to file an application directed toward the technology that is the subject of our patent applications. Competitors may have filed patent applications or received patents and may obtain additional patents or other proprietary rights that block or compete with our products. In addition, if competitors file patent applications covering our technology, we may have to participate in interference/derivation proceedings or litigation to determine the right to a patent. Litigation and interference/derivation proceedings are unpredictable and expensive, such that, even if we are ultimately successful, our results of operations may be adversely affected by such events. Accordingly, there is a risk that any patent applications that we file and any patents that we hold or later obtain could be challenged by third parties and be declared invalid in view of third-party patent applications and/or patents or through other proceedings before the U.S. Patent and Trademark Office such as post-grant reviews, reexaminations, and inter partes’ reviews, or oppositions and other comparable proceedings in foreign jurisdictions. Litigation, interferences, oppositions, inter partes’ reviews or other proceedings are, have been and may in the future be necessary in some instances to determine the validity and scope of certain of our proprietary rights, and in other instances to determine the validity, scope or non-infringement of certain patent rights claimed by third parties to be pertinent to the manufacture, use or sale of our products. We may also face challenges to our patent and regulatory protections covering our products by third parties, including manufacturers of generics and biosimilars that may choose to launch or attempt to launch their products before the expiration of our patent or regulatory exclusivity. Litigation, interference, oppositions, inter partes’ reviews, administrative challenges or other similar types of proceedings are unpredictable and may be protracted, expensive and distracting to management. The outcome of such proceedings could adversely affect the validity and scope of our patent or other proprietary rights, hinder our ability to manufacture and market our products, require us to seek a license for the infringed product or technology or result in the assessment of significant

monetary damages against us that may exceed any amounts that we may accrue on our financial statements as a reserve for contingent liabilities. An adverse determination in a judicial or administrative proceeding or a failure to obtain necessary licenses could prevent us from manufacturing or selling our products. Furthermore, payments under any licenses that we are able to obtain would reduce our profits derived from the covered products and services.

The enforcement of patent rights often requires litigation against third-party infringers, and such litigation can be costly to pursue. Even if we succeed in having new patents issued or in defending any challenge to issued patents, there is no assurance that our patents will be comprehensive enough to provide us with meaningful patent protection against our competitors.

Employees

As of December 31, 2025, we had 77 employees, of which 22 were employed by Lineage and 55 were employed by CCN and work in Israel. Of the 77 employees, 72 were employed on a full-time basis and five were employed on a part-time basis. Twelve employees hold Ph.D. degrees in one or more fields of science or doctorates in medicine. None of our employees are covered by a collective bargaining agreement.

Manufacturing

Manufacturing of pluripotent-derived products is complex and requires the use of innovative technologies to handle living cells. Manufacturing these products requires facilities specifically designed for and validated for this purpose and specific quality assurance and quality control procedures are necessary. Currently, all of our cGMP manufacturing processes, including cell banking, staff training, and product manufacturing for our cell therapy product candidates, are conducted at our internally-controlled facility at CCN. The facility, which includes process development laboratories and a cGMP manufacturing facility, is designed and equipped to enable simultaneous cGMP processes and to produce a range of cell therapy products for human use in clinical trials as well as at a scale suitable for commercial launch.

Our process development and manufacturing are designed to address the complexity of manufacturing cell-based therapies with a specific focus on the reproducibility and scale of the manufacturing process. To this end each of our manufacturing processes contains predefined steps that are controlled by a specific set of control tests that allow us to follow up the progression of production according to the manufacturing plan. We implement a variety of 2-dimensional and 3-dimensional culture conditions to address the specific requirements of our pre-defined differentiation processes of the pluripotent cell into a functional cell product.

We obtain key materials required for the manufacture of our cell therapy product candidates from third-party manufacturers and suppliers, which include, in some instances, sole source manufacturers and suppliers. We do not currently have long-term commitments or supply agreements in place to obtain certain key materials used in the manufacture of our cell therapy product candidates.

Licensed Technology and Product Development Agreements

Lineage has obtained the right to use various technologies that we believe have great potential in our product development efforts, and that may be useful to other companies that are engaged in the research and development of products for human therapeutic and diagnostic use.

Second Amended and Restated License Agreement

In June 2017, CCN entered into a Second Amended and Restated License Agreement (the “Hadasit License Agreement”) with Hadasit, pursuant to which Hadasit granted CCN an exclusive, worldwide, royalty bearing license (with the right to grant sublicenses) in its intellectual property portfolio of materials and technology related to human stem cell derived (i) photoreceptor cells and (ii) retinal pigment epithelial cells (collectively, the “Licensed IP”), to use, commercialize and exploit any part thereof, in any manner whatsoever in the fields of the development and exploitation of (i) human stem cell derived photoreceptor cells, solely for use in cell therapy for the diagnosis, amelioration, prevention and treatment of eye disorders (the "Photoreceptor Field"), and (ii) human stem cell derived

retinal pigment epithelial cells, solely for use in cell therapy for the diagnosis, amelioration, prevention and treatment of eye disorders. The development and exploitation of human stem cell derived photoreceptor cells (“PR Development Program”) is governed by a Research Agreement (“PR Research Agreement”) made part of and attached to the Hadasit License Agreement.

As consideration for the Licensed IP, CCN paid a one time lump sum payment and will pay a royalty in the low single digits of net sales from sales of Licensed IP by any invoicing entity, and a low double-digit percent of sublicensing receipts. In addition, under certain circumstances, CCN is required to pay Hadasit an annual minimal non-refundable royalty.

CCN further agreed to pay Hadasit non-refundable milestone payments upon the recruitment of the first patient for the first Phase IIB clinical trial, upon the enrollment of the first patient in the first Phase III clinical trials, upon delivery of the report for the first Phase III clinical trials, upon the receipt of an NDA or marketing approval in the European Union (“EU”), whichever is the first to occur, and upon the first commercial sale in the United States or EU, whichever is the first to occur.

The Hadasit License Agreement was amended on November 30, 2017 (“First Amendment”) to update the original list of patent applications and issued patents for Licensed IP, and provide for reimbursement of certain costs associated with a patent not originally listed in the Hadasit License Agreement to CCN. The Hadasit License Agreement was amended on December 1, 2019 to replace PR Research Agreement with a new PR Research Agreement (“New PR Research Agreement”) which included provisions with respect to the ownership of research results and intellectual property. The Hadasit License Agreement was further amended on December 17, 2021 by a letter agreement pursuant to which CCN is obligated to pay a maximum of 21.5% of any milestone payments Lineage receives under the Roche Agreement (subject to certain reductions, including for costs related to Lineage’s performance obligations under the Roche Agreement) and up to 50% of all royalty payments (subject to a maximum payment of 5% of net sales of products), Lineage receives under the Roche Agreement. We removed the Photoreceptor Field from the scope of the Hadasit License Agreement, in April 2024.

The Hadasit License Agreement terminates upon the expiration of CCN’s obligation to pay royalties for all licensed products, unless earlier terminated. In addition, the Hadasit License Agreement may be terminated by (i) Hadasit if, among other reasons, CCN fails to continue the clinical development of the Licensed IP or fails to take actions to commercialize or sell the Licensed IP over any consecutive 12 month period, and (ii) by either party for (a) a material breach which remains uncured following a cure period, or (b) the granting of a winding-up order in respect of the other party, or upon an order being granted against the other party for the appointment of a receiver or a liquidator in respect of a substantial portion of such other party’s assets. The Hadasit License Agreement also contains mutual confidentiality obligations of CCN and Hadasit, and indemnification obligations of CCN.

WARF Agreements

We have rights to certain U.S. and international issued patents, pending patent applications, and stem cell lines from the Wisconsin Alumni Research Foundation (“WARF”) under an Amended and Restated Non-Exclusive License Agreement we entered into with WARF on March 3, 2026. Until the time we entered into that agreement, such rights were granted to us under two agreements, one agreement between WARF and Asterias Biotherapeutics Incorporated, our wholly-owned subsidiary, entered into in 2013, and one between us and WARF entered into in 2008. See Item 9B. “Other Information,” below for additional information.

Government Regulation

Government authorities at the federal, state and local level, and in other countries, extensively regulate among other things, the development, testing, manufacture, quality, approval, safety, efficacy, distribution, labeling, packaging, storage, record keeping, monitoring, reporting, marketing, import/export and promotion of drugs, biologics, and medical devices. Authorities also heavily regulate many of these activities for human cells, tissues, and cellular and tissue-based products (“HCT/Ps”).

FDA and Foreign Regulation of Therapeutic Products

The FDA and foreign regulatory authorities will regulate our proposed products as drugs, biologics or medical devices, depending upon such factors as the use to which the product will be put, the chemical composition, and the interaction of the product with the human body. In the United States, the FDA regulates drugs, biologics and medical devices, among other products, under the Federal Food, Drug and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”), and implementing regulations. Under this regulatory structure, establishments that manufacture biologics that are HCT/Ps are subject to all regulations applicable to drug/biologics, as well as HCT/P-specific regulations, including, but not limited to, current good tissue practices (“cGTP”) and contagious disease prevention requirements. Certain proposed cell therapy products will be reviewed by the FDA staff in its Center for Biologics Evaluation and Research Office of Therapeutic Products. Drugs, biologics, and devices are also subject to other federal, state, and local statutes and regulations.

Our human drug and biologic products will be subject to rigorous FDA review and approval procedures before they may be marketed in the United States. After testing in animals to evaluate the potential efficacy and safety of the product candidate, an IND submission must be made to the FDA to obtain authorization for human testing. Extensive clinical testing, which is generally done in three phases, must then be undertaken to demonstrate substantial evidence of safety and efficacy of each product in humans. Each clinical trial is conducted under the auspices of an independent Institutional Review Board (“IRB”). The IRB will consider, among other things, ethical factors, the safety of human subjects, and the possible liability of the institution.

Phase 1 clinical trials are conducted in a small number of healthy volunteers or volunteers with the target disease or condition to assess safety and dosage, and to identify adverse effects. Phase 2 clinical trials are conducted with groups of patients afflicted with the target disease or condition in order to determine preliminary efficacy, optimal dosages and expanded evidence of safety. In some cases, an initial trial is conducted in diseased patients to assess both preliminary safety and preliminary efficacy, in which case it is referred to as a Phase 1/2 clinical trial. Phase 3 clinical trials are large-scale, multicenter, comparative trials and are conducted with patients afflicted with the target disease or condition in order to monitor adverse effects and provide enough data to demonstrate the efficacy and safety required by the FDA. The FDA closely monitors the progress of each of the three phases of clinical testing and may, at its discretion, re-evaluate, alter, suspend or terminate the clinical trial based upon the data which have been accumulated to that point and FDA's assessment of the risk/benefit ratio to the intended patient population. The clinical trial sponsor is required to report adverse events to the FDA and IRB in accordance with FDA laws and regulations. Monitoring of all aspects of the trial to minimize risks is a continuing process.

Post-approval trials, sometimes referred to as Phase 4 studies, may be conducted after initial approval. These trials are used to gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA/BLA.

In addition, the Pediatric Research Equity Act (“PREA”), requires a sponsor to conduct pediatric clinical trials for most drugs and biologics, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration. Under PREA, original NDAs/BLAs and supplements must contain a pediatric assessment unless the sponsor has received a deferral or waiver. The required assessment must evaluate the safety and efficacy, or safety, purity, and potency of the product for the claimed indications in all relevant pediatric subpopulations and support dosing and administration for each pediatric subpopulation for which the product is deemed safe and effective, or safe, pure, and potent. The sponsor may request or the FDA may grant a deferral of pediatric clinical trials for some or all of the pediatric subpopulations. A deferral may be granted for several reasons, including a finding that the drug is ready for approval for use in adults before pediatric clinical trials are complete or that additional safety or effectiveness data needs to be collected before the pediatric clinical trials begin. The FDA must send a non-compliance letter to any sponsor that fails to submit the required assessment, keep a deferral current, or fails to submit a request for approval of a pediatric formulation. No action can be taken to market any therapeutic product in the U.S. until a New Drug Application (“NDA”) or Biologics License Application (“BLA”), as applicable, has been approved by the FDA. Submission of the application is not a guarantee that the FDA will find it complete and accept it for filing. If an application is accepted for filing, following the FDA’s review of safety and efficacy data compiled from clinical trials, the FDA may grant marketing approval, or deny the application by way of a complete response letter (“CRL”) if it determines that the application does not provide an adequate basis for approval. A CRL indicates that the review cycle for the application is complete, and the application will not be approved in its present form. A CRL usually describes the specific deficiencies in the NDA/BLA identified by the FDA and may require additional clinical data,

including additional clinical trials or other significant and time-consuming requirements related to clinical trials, nonclinical studies, or manufacturing. If a CRL is issued, the sponsor must resubmit the NDA/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 resubmitted NDA/BLA does not satisfy the criteria for approval. FDA regulations also restrict the export of therapeutic products for clinical use prior to FDA approval. Under the Prescription Drug User Fee Act (“PDUFA”) guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing” of an NDA/BLA for a new molecular entity to complete a standard review and act on the submission. This review typically takes twelve months from the date the NDA/BLA is submitted to FDA because the FDA has approximately two months to make a “filing” decision after the application is submitted.

Before approving an NDA or BLA, the FDA will inspect the facilities at which the product is manufactured or perform an establishment file review of the site. The FDA will not approve the product unless it determines that the manufacturing processes and facilities are in compliance with the requirements of current Good Manufacturing Practices (“cGMPs”) and adequate to assure consistent production of the product within required specifications including good tissue practices (“GTPs”) to the extent applicable. FDA's cGMP regulations detail minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. FDA's GTP regulations and guidance documents govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps. 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 when applicable, evaluation of donors through screening and testing. To maintain compliance with cGMPs, GTPs, and good clinical practices ("GCPs"), an applicant must incur significant expenditure of time, money and effort in areas including, but not limited to, training, record keeping, production, and quality control.

If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which could restrict the commercial value of the product. In addition, the FDA may require that contraindications, warnings or precautions be included in the product’s labeling; require that post-approval studies be conducted to further assess the drug’s safety or effectiveness; require testing and surveillance programs to monitor the safety of the commercialized product; or impose other conditions, including distribution restrictions or other risk management mechanisms, including a risk evaluation and mitigation strategy (“REMS”) to assure safe use of the product. If the FDA concludes a REMS is needed, the sponsor of the NDA/BLA must submit a proposed REMS, which could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries, and other risk minimization tools. The FDA will not approve the NDA/BLA without an approved REMS, if required. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of products.

To date, although there are clinical trials of pluripotent stem cell-derived therapeutic products ongoing, we do not believe that the FDA has granted marketing approval to any pluripotent stem cell-based therapeutic products, and it is possible that the FDA or foreign regulatory agencies may subject our product candidates to additional or more stringent review than drugs or biologics derived from other technologies.

The FDA offers several programs to expedite development of products that treat serious or life-threatening illnesses and that provide meaningful therapeutic benefits to patients over existing treatments. Such programs include (i) Fast Track designation; (ii) Breakthrough Therapy designation; (iii) Accelerated Approval pathway; (iv) Priority Review designation; and (v) Regenerative Medicine Advanced Therapy (“RMAT”) designation.

Drugs/biologics awarded Fast Track designation give the sponsor additional opportunities to interact with FDA reviewers during the drug development and review process. Early and frequent communication with FDA can address questions and issues which can lead to faster approval. An additional feature of Fast Track designation is rolling review which allows FDA to review portions of a drug/biologic sponsor’s NDA or BLA before the complete application is submitted. Eligible Fast Track drugs must treat a serious condition and nonclinical or clinical data must demonstrate the potential to address unmet medical need. Dru/biologic sponsors can request Fast Track designation during the drug development process, generally before submitting an NDA or BLA.

Drugs awarded Breakthrough Therapy designation have all features of Fast Track designation plus organizational commitment from FDA senior managers to interact and provide intensive guidance on drug development during the clinical phases. Eligible Breakthrough Therapy drugs must treat a serious condition and preliminary clinical evidence indicates that the drug/biologic may demonstrate substantial improvement on a clinically

significant endpoint(s) over available therapies. Drug/biologic sponsors can request Breakthrough Therapy designation no later than the end of phase II clinical trial meetings with FDA. Alternatively, FDA may suggest the sponsor request Breakthrough Therapy designation if the Agency believes the drug/biologic is eligible and can benefit from the designation.

A drug/biologic in the Accelerated Approval pathway is approved based on a surrogate endpoint or intermediate endpoint that is reasonably likely to predict a drug’s clinical benefit, such as decreased morbidity and mortality. Because it can often take years to measure primary outcomes like survival, surrogate or intermediate endpoints (e.g. decreasing biomarker levels, imaging results) can serve as a proxy for clinical benefit. Eligible Accelerated Approval drugs/biologics must treat a serious condition, provide a meaningful advantage over available therapies, and demonstrate 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 and mortality or other clinical benefit. Sponsors generally explore the possibility of Accelerated Approval with FDA early in the development process (e.g. during the design of clinical trials).

For drugs with Priority Review designation, FDA’s goal is to act on a drug sponsor’s marketing application within six months rather than the usual 10 months for a standard review process. Eligible Priority Review drugs must treat a serious condition and provide a significant improvement in safety or effectiveness over existing treatments. Drug sponsors can request Priority Review when they submit either an NDA or BLA. Another method for a drug sponsor to obtain Priority Review designation is through a Priority Review Voucher. If a drug sponsor develops a treatment for a neglected tropical disease, rare pediatric disease, or medical countermeasure it can be awarded a Priority Review Voucher which can be redeemed at the drug sponsor’s discretion to obtain Priority Review or sold to another sponsor to use for the same purpose. A drug sponsor with a Priority Review Voucher will inform FDA of its intent to use the voucher when it submits either an NDA or BLA. Priority Review Vouchers can be awarded for drugs/biologics intended to treat tropical diseases, rare pediatric diseases, or material threat countermeasures. Additionally, in June 2025, the FDA launched the Commissioner’s National Priority Voucher (“CNPV”) pilot program, offering drug manufacturers an expedited 30 to 60-day review by proposing plans to advance five stated priorities, which include addressing public health crises, delivering innovative cures, meeting unmet medical needs, strengthening supply chains through onshore drug manufacturing, and increasing affordability. The FDA cites examples that include developing novel medicines for obesity, PTSD, other chronic diseases, or creating universal flu vaccines. Proposals may also include domestic manufacturing expansions and commitments for the firm to implement “most favored nation” pricing models on some of their drugs. Proposals are not required to address all five priority areas, but more comprehensive plans are likely to be favored in the selection process.

A drug is eligible for RMAT designation if: the drug is a regenerative medicine therapy, 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, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;; the drug is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition; and preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition.

Exclusivity Programs

Additionally, FDA administers several statutory marketing exclusivity programs for drugs and biologics that operate independently of patent protection and prevent FDA from approving (or, in some cases, even accepting) certain competing applications for defined periods. Key programs include 3-year clinical investigation exclusivity (for new indications or changes supported by new clinical studies), pediatric exclusivity (a 6-month add-on to existing exclusivities and patents), 12-year reference product exclusivity for biologics under the Biologics Price Competition and Innovation Act (“BPCIA”), and – most notably for our purposes – Orphan Drug Designation exclusivity (7 years for the approved rare-disease indication). These exclusivities differ in scope, trigger, and blocking effect (e.g., approval block vs. filing block), and may run concurrently or sequentially depending on the product’s regulatory pathway.

The FDCA provides three years of non-patent exclusivity for an NDA/BLA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the modification for which the drug received approval based on the new clinical investigations and does not prohibit the FDA from approving ANDAs or 505(b)(2) NDAs

for drugs containing the active agent for the original indication or condition of use. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA. However, an applicant submitting a full NDA would be required to conduct, or obtain a right of reference to, all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

Pediatric exclusivity is another type of marketing exclusivity available in the United States. Pediatric exclusivity provides for an additional six months of marketing exclusivity attached to an existing period of regulatory exclusivity or available patent term if a sponsor conducts clinical trials in children in response to a “written request” from the FDA. The issuance of a written request does not require the sponsor to undertake the described clinical trials, and the FDA’s grant of pediatric exclusivity does not require the FDA to approve labeling containing information on pediatric use based on the studies conducted.

The BPCIA grants 12 years of exclusivity for brand-name biologics (subject to an approved BLA) from the date of first licensure, preventing FDA approval of biosimilars during this period. It includes 4 years of data exclusivity (no biosimilar application submission) and 8 years of marketing exclusivity, with 1 year of extra, separate exclusivity for the first-approved interchangeable biosimilar.

Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States, or, if it affects more than 200,000 individuals in the United States, there is no reasonable expectation that the cost of developing and making available a drug or biologic for this type of disease or condition will be recovered from sales in the United States for that drug or biologic. Orphan drug designation is a separate process from seeking an NDA or BLA. After the FDA grants orphan drug designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. The orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product may be entitled to orphan drug exclusivity, which, as codified by the Consolidated Appropriations Act of 2026, means that the FDA may not approve any other applications, including a full NDA or BLA, to market the same drug/biologic for the “same approved use or indication within such rare disease or condition” for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity. Orphan drug exclusivity does not prevent FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the NDA or BLA application fee. A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. In addition, exclusive marketing rights in the United States 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 product to meet the needs of patients with the rare disease or condition.

Combination Products

Combination products are defined by the FDA to include products comprised of two or more regulated components or parts such as a biologic and a device. Combination products may be reviewed in a single application or in separate applications for the constituent parts. Whether the constituent parts (e.g., a biologic and a device) are reviewed together as a combination product or separately under two different marketing applications, each constituent part must meet the regulatory requirements applicable to that constituent part (e.g., biologic-specific regulations for the biologic constituent part and device-specific regulations for the device constituent part). Further, the regulatory requirements for a combination product comprised of a biologic administered with a delivery device can be more complex because, in addition to the individual regulatory requirements for each component, additional combination product regulatory requirements may apply. The Office of Combination Products at the FDA coordinates the review of such products and determines the primary mode of action of a combination product. The definition and regulatory requirements for combination products may differ significantly among countries in which we may seek approval of our product candidates.

FDA Regulation of Manufacturing

The FDA regulates the manufacturing process of pharmaceutical products, HCT/Ps, and medical devices, requiring that they be produced in compliance with cGMP and GTP. See “Manufacturing", above. The FDA regulates and inspects equipment, facilities, laboratories and processes used in the manufacturing and testing of products prior to providing approval to market products. If, after receiving approval from the FDA, a material change is made to manufacturing equipment or to the location or manufacturing process, additional regulatory review may be required. The FDA also conducts regular, periodic visits to re-inspect the equipment, facilities, laboratories and processes of manufacturers following an initial approval. If, as a result of a post-approval inspection, the FDA determines that equipment, facilities, laboratories or processes do not comply with applicable FDA regulations and conditions of product approval, the FDA may seek civil, criminal or administrative sanctions and/or remedies against the manufacturer, including, but not limited to, suspension of manufacturing operations. Issues pertaining to manufacturing equipment, facilities or processes may also delay the approval of new products undergoing FDA review.

FDA Regulation of Advertising and Product Promotion

The FDA also regulates the content of advertisements used to market pharmaceutical and biologic products. Claims made in advertisements concerning the safety and efficacy of a product, or any advantages of a product over another product, must be supported by clinical data filed as part of an NDA, a BLA, or an amendment to an NDA or a BLA, and must be consistent with the FDA-approved labeling and dosage information for that product. Additionally, the FDCA prohibits manufacturers of pharmaceutical and/or biologic products from making any claims, implicit or explicit, that are "false or misleading in any particular".

Pharmaceutical and biologic products may be promoted only for the approved indications in accordance with the approved label. The FDA and other agencies, like the Federal Trade Commission (“FTC”), actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label may be subject to significant liability. However, physicians may, in their independent medical judgment, prescribe legally available products for off-label uses. The FDA does not regulate the behavior of physicians in their choice of treatments but the FDA does restrict manufacturer’s communications on the subject of off-label use of their products.

Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising, and potential civil and criminal penalties.

Increased scrutiny over direct-to-consumer (“DTC”) drug advertising has been a priority of this administration, particularly the U.S. Department of Health and Human Services (“HHS”). On September 9, 2025, the FDA announced a crackdown on deceptive drug advertising, sending thousands of letters warning pharmaceutical companies to remove misleading ads, and issuing many enforcement letters to companies with deceptive ads. We expect that the administration will continue to closely monitor and enforce against DTC advertising of drug and biologic products.

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of requirements for post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

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

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fines, warning letters, or untitled letters;

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clinical holds on ongoing or planned clinical studies;

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

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

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

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

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

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injunctions or the imposition of civil or criminal penalties.

Foreign Regulation

Sales of pharmaceutical products outside the U.S. are subject to foreign regulatory requirements that vary widely from country to country. Even if FDA approval has been obtained, approval of a product by comparable regulatory authorities of foreign countries must be obtained prior to the commencement of marketing the product in those countries. The time required to obtain such approval may be longer or shorter than that required for FDA approval.

Federal Funding and State Regulations

Prior to January 2026, the use of hES cells in federally funded research was governed primarily by the 2009 National Institute of Health ("NIH") policy, which required that hES cells used in federally funded research are derived from human embryos that were created for reproductive purposes, are no longer needed for this purpose, and are voluntarily donated for research purposes with the informed written consent of the donors. However, on January 22, 2026, NIH announced a new policy, effective immediately, that NIH funds will no longer be used to support research involving hES from elective abortions – which provides an additional layer of restriction for hES use in federally funded research on top of the 2009 policy. The new policy applies across the NIH Intramural Research Program and all NIH-supported extramural research, including grants, cooperative agreements, other transaction awards, and research and development contracts.

The State of California has adopted legislation and regulations that require institutions that conduct stem cell research to notify, and in certain cases obtain approval from, a Stem Cell Research Oversight Committee (“SCRO Committee”) before conducting the research. Under certain California regulations, all hES cell lines used in our research must be acceptably derived. California regulations further require certain records to be maintained with respect to stem cell research and the materials used. Lineage programs that involve the use of stem cells have been reviewed by a SCRO Committee to confirm compliance with federal and state guidelines.

The hES cell lines that we use are all on the NIH registry of lines that have been reviewed and meet standards for federal funding grants. All of our research programs utilize stem cells from established and well-characterized cell lines and which are capable of self-renewal and expansion through normal cellular division (mitosis). Our research programs do not require new tissue or cells from donors of any kind.

Health Insurance Portability and Accountability Act and Other Health Information Privacy and Security Laws

The Health Insurance Portability and Accountability Act (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their respective implementing regulations impose obligations on “covered entities,” including certain healthcare providers, health plans, and healthcare clearinghouses, as well as their respective “business associates” that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, and their subcontractors that use, disclose, access, or otherwise process individually identifiable protected health information, with respect to protecting the privacy, security, and transmission of protected health information. HIPAA also regulates standardization of data content, codes and formats used in healthcare transactions and standardization of identifiers for covered health plans and providers. Penalties for violations of HIPAA regulations include civil and criminal penalties. Additionally, HITECH created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce HIPAA and seek attorneys’ fees and costs associated with pursuing federal

civil actions. In addition, certain state and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Privacy and Data Security Laws

In the ordinary course of our business, we may collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, processing) personal data and other sensitive information, including data we collect about trial participants in connection with clinical trials. Accordingly, we are, or may become, subject to numerous data privacy and security requirements related to data privacy, security, and protection under federal, state, local, and foreign laws, regulations, guidance, and industry standards, many of which place restrictions on the Company's ability to transfer, access and use personal data across its business. Compliance with such requirements increases the cost and complexity of doing business and non-compliance may result in, among other penalties and sanctions, substantial monetary fines. The landscape of data privacy laws is evolving, with increasingly stringent regulatory frameworks related to personal data processing, which increase compliance obligations and exposure for noncompliance. In some jurisdictions violations may subject us to fines. For example, under the EU’s General Data Protection Regulation 2016/679 (“EU GDPR”), government regulators may impose temporary or definitive bans on data processing, as well as fines of up to 20 million euros or 4% of a company’s annual global revenue, whichever is greater. Further, some laws allow individuals to initiate litigation related to processing of their personal data.

The laws to which we may be subject include privacy-specific laws at a state level such as the California Consumer Privacy Act of 2018 (“CCPA”). Other countries in which we operate also have general privacy obligations, including Israel’s Protection of Privacy Law 5741-1981, the EU GDPR, and the UK’s similar privacy law (“UK GDPR”). These non-US laws apply to processing of personal data of residents, and may apply to some of our activities. Some of our uses of personal information may be subject to specific privacy laws, such as the Telephone Consumer Protection Act or the CAN-SPAM Act. Obligations under these privacy laws may include data minimization, notification, consent, contractual provisions with third parties, restrictions on transfers from one country to another (such as restrictions under EU GDPR and UK GDPR of transfers of personal data to the US unless certain provisions have been met), and record keeping obligations. We are also subject to a complex patchwork of data security and breach notification laws, which exist at a state level in the US (in addition to obligations under HIPAA, discussed above), and also in laws outside of the US, such as GDPR and UK GDPR. Obligations under these laws may include notification in the event of a data breach; limiting personal data processing to only what is necessary for specified, explicit, and legitimate purposes; implementing and maintaining technical and organizational safeguards for personal data. In addition to privacy and data security specific legislation, there are also enforcements brought under unfair and deceptive trade practice laws, such as Section V of the FTC Act. Regulators often issue guidance to assist companies, which guidance is frequently updated, and these guidance are relied on by enforcement bodies and courts.

There is a growing trend towards required public disclosure of clinical trial data in the EU which adds to the complexity of obligations relating to processing health data from clinical trials. Failing to comply with these obligations could lead to government enforcement actions and significant penalties against the Company, harm to its reputation, and adversely impact its business and operating results. The uncertainty regarding the interplay between different regulatory frameworks further adds to the complexity that the Company faces with regard to data protection regulation. In addition, Israel’s Protection of Privacy Law 5741-1981 and the regulations promulgated thereunder impose certain obligations with respect to the manner personal data is processed, and government regulators may issue fines or sanctions for non-compliance.

In certain circumstances we may transfer personal information of EU individuals to the US. Often we rely on standard contractual clauses. These have been questioned by privacy advocates, which scrutiny has grown under the Trump administration, and their sufficiency be subject to legal review. In addition, Switzerland and the UK similarly restrict personal data transfers outside of those jurisdictions to countries, such as the United States, that do not provide an adequate level of personal data protection, and certain countries outside Europe (e.g., Israel) have also passed or are considering laws requiring local data residency or otherwise impeding the transfer of personal data across borders.

In addition, business practices in the healthcare industry have come under increased scrutiny, particularly in the U.S., by government agencies (e.g., the U.S. Federal Trade Commission (the “FTC”) and the HHS and state attorneys

general, which continue to stress the intersection of health and privacy as a compliance and enforcement priority. Resulting investigations and prosecutions carry the risk of significant civil and criminal penalties. Of note is the increased enforcement activity by data protection authorities in various jurisdictions, particularly in the EU, where significant fines have been levied on companies for data breaches, violations of privacy requirements, and unlawful cross-border data transfers. In the U.S., the FTC has stepped up enforcement of data privacy with several significant settlements (including settlements concerning the downstream sharing of personal information and use and disclosure of personal health data) and there have been a material increase in class-action lawsuits linked to the collection and use of biometric data and use of tracking technologies.

Federal and State Fraud and Abuse Laws

A variety of federal and state laws prohibit fraud and abuse. These laws are interpreted broadly and enforced aggressively by various state and federal agencies, including the Centers for Medicare & Medicaid Services (“CMS”), the Department of Justice, the Office of Inspector General for the HHS, and various state agencies. In addition, the Medicare and Medicaid programs increasingly use a variety of contractors to review claims data and to identify improper payments as well as fraud and abuse. These contractors include Recovery Audit Contractors, Medicaid Integrity Contractors and Zone Program Integrity Contractors. In addition, CMS conducts Comprehensive Error Rate Testing audits, the purpose of which is to detect improper Medicare payments. Any overpayments identified must be repaid unless a favorable decision is obtained on appeal. In some cases, these overpayments can be used as the basis for an extrapolation, by which the error rate is applied to a larger universe of claims, and which can result in even higher repayments.

The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting, receiving, or providing remuneration, directly or indirectly, to induce or in return for either the referral of an individual, or the furnishing, recommending, or arranging for the purchase, lease or order of any healthcare item or service reimbursable, in whole or in part, under a federal healthcare program. The definition of “remuneration” has been broadly interpreted to include anything of value, including gifts, discounts, credit arrangements, payments of cash, ownership interests and providing anything at less than its fair market value. Recognizing that the federal Anti- Kickback Statute is broad and may prohibit certain common activities within the healthcare industry, the Office of Inspector General for HHS has issued a series of statutory exceptions and regulatory “safe harbors.” However, these exceptions and safe harbors are drawn narrowly and require strict compliance in order to offer protection from prosecution under the federal Anti-Kickback Statute. Although payment and business practices that meet the requirements of a safe harbor are not treated as offenses under the federal Anti-Kickback Statute, the failure of a transaction or arrangement to fit within a specific safe harbor does not necessarily mean that the transaction or arrangement is illegal or that prosecution under the federal Anti-Kickback Statute will be pursued. However, conduct and business arrangements that do not fully satisfy all requirements of an applicable safe harbor may result in increased scrutiny by government enforcement authorities and would be evaluated on a case-by-case basis based on a cumulative review of their facts and circumstances. Additionally, the Patient Protection and Affordable Care Act, as amended by the Healthcare and Education Reconciliation Act (collectively, the “ACA”) codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act.

The federal civil and criminal false claims laws, including the federal False Claims Act, which can be enforced by private citizens on behalf of the government, through civil whistleblower or qui tam actions, and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent. Pharmaceutical and other healthcare companies have been prosecuted under these laws for alleged off-label promotion of drugs, purportedly concealing price concessions in the pricing information submitted to the government for government price reporting purposes, and allegedly providing free product to customers with the expectation that the customers would bill federal healthcare programs for the product. As a result of a modification made by the Fraud Enforcement and Recovery Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government. In addition, manufacturers can be held liable under the federal False Claims Act even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims.

HIPAA also created new federal crimes, including healthcare fraud and false statements relating to healthcare matters. The healthcare fraud statute prohibits knowingly and willfully executing a scheme to defraud any healthcare

benefit program, including private third-party payers. The false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), certain other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

Many states have laws similar to the federal laws described above and the state laws may be broader in scope and may apply regardless of payor, such as state anti-kickback and false claims laws that may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third party payors, including private insurers, or that apply regardless of payor, state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, state and local laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, state laws that require the reporting of information related to drug pricing, and state and local laws requiring the registration of pharmaceutical sales representatives.

Additionally, the U.S. Foreign Corrupt Practices Act (“FCPA”) prohibits U.S. corporations and their representatives from offering, promising, authorizing or making payments to any foreign government official, government staff member, political party or political candidate in an attempt to obtain or retain business abroad. The scope of the FCPA includes interactions with certain healthcare professionals in many countries. Other countries have enacted similar anti-corruption laws and/or regulations.

If our operations are found to be in violation of any of the laws described above, or any other governmental regulations that apply to us, we may be subject to significant civil, criminal and administrative penalties, including sanctions, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, imprisonment, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations.

Coverage and Reimbursement

Patients generally rely on third-party payors to reimburse part or all of the costs associated with medical products. Accordingly, market acceptance of medical products can depend on the extent to which third-party coverage and reimbursement is available from government health administration authorities, private healthcare insurers and other healthcare funding organizations. No uniform policy for coverage and reimbursement exists in the United States, and coverage and reimbursement can differ significantly from payor to payor. Decisions regarding whether to cover any of our product candidates, if approved, the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement rates, but also have their own methods and approval process apart from Medicare determinations. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our product candidates to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Pharmaceutical companies may be required to provide specified rebates or discounts on the products it sells to certain government funded programs, including Medicare and Medicaid, and those rebates or discounts have increased over time. The ACA increased many of these mandatory discounts and rebates required and imposed a new branded prescription pharmaceutical manufacturers and importers fee payable each year by certain pharmaceutical companies and manufacturers.

Outside of the United States, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. For example, the EU

provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product, or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. Historically, products launched in the EU do not follow price structures of the United States and generally tend to be significantly lower.

Healthcare Reform

The United States and some foreign jurisdictions are considering or have enacted a number of reform proposals to change the healthcare system. There is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by federal and state legislative initiatives, including those designed to limit the pricing, coverage, and reimbursement of pharmaceutical and biopharmaceutical products, especially under government-funded healthcare programs, and increased governmental control of drug pricing.

LCTX US Equity

LCTX · 10-K · period ended 2025-12-31

ITEM 1. BUSINESS

LCTX US Equity☆

LCTX · 10-K · period ended 2025-12-31

ITEM 1. BUSINESS

LCTX US Equity