GERON CORP
For the period ended Dec 31, 2025. Filed Mar 2, 2026.
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FY2025 · Filed Mar 2, 2026
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Table of Contents
| Page | ||
|---|---|---|
| PART I | ||
| Item 1. | Business | 5 |
| Item 1A. | Risk Factors | 26 |
| Item 1B. | Unresolved Staff Comments | 77 |
| Item 1C. | Cybersecurity | 77 |
| Item 2. | Properties | 78 |
| Item 3. | Legal Proceedings | 79 |
| Item 4. | Mine Safety Disclosures | 79 |
| PART II | ||
| Item 5. | Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 80 |
| Item 6. | [Reserved] | 80 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 81 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 96 |
| Item 8. | Financial Statements and Supplementary Data | 97 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 139 |
| Item 9A. | Controls and Procedures | 139 |
| Item 9B. | Other Information | 140 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 140 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance | 141 |
| Item 11. | Executive Compensation | 141 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 141 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 141 |
| Item 14. | Principal Accountant Fees and Services | 142 |
| PART IV | ||
| Item 15. | Exhibits and Financial Statement Schedules | 143 |
| Item 16. | Form 10‑K Summary | 146 |
| SIGNATURES | 147 | |
RYTELO® and other trademarks or service marks of Geron Corporation appearing in this Annual Report on Form 10-K
(this "Report") are the property of Geron Corporation. This Report contains additional trade names, trademarks and service
marks of others, which are the property of their respective owners. We do not intend our use or display of other companies’
trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, these other
companies.
In this Report, unless otherwise indicated or the context otherwise requires, “Geron,” “the registrant,” “we,” “us,” and
“our” refer to Geron Corporation, a Delaware corporation, and its wholly owned subsidiaries, Geron UK Limited, a United
Kingdom company, and Geron Netherlands, B.V., a Dutch company.
Forward‑Looking Statements
This Report, including “Business” in Part I, Item 1 of this Report and “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of this Report, contains forward‑looking
statements that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect,
could cause the results of Geron Corporation, or Geron or the Company, to differ materially from those expressed or
implied by such forward‑looking statements. All statements other than statements of historical fact are statements that
could be deemed forward‑looking statements. In some cases, forward‑looking statements can be identified by the use of
terminology such as “may,” “expects,” “plans,” “intends,” “will,” “should,” “could,” “projects,” “believes,” “predicts,”
“anticipates,” “estimates,” “potential,” “seek,” or “continue” or the negative thereof or other comparable terminology. The
risks and uncertainties referred to above include, without limitation, risks and uncertainties related to: (a) whether we are
successful in commercializing RYTELO (imetelstat) for the treatment of certain patients with lower-risk myelodysplastic
syndromes, or lower-risk MDS, with transfusion dependent anemia; (b) whether the U.S. Food and Drug Administration, or
FDA, or European Commission, or EC, will approve RYTELO for other indications on the timelines that may be expected,
or at all; (c) our pursuit of paths to make RYTELO available to eligible patients with lower-risk MDS outside of the U.S.,
including in the European Union, or EU; (d) whether we overcome potential delays and other adverse impacts caused by
enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in
order to have the financial resources for and meet expected timelines and planned milestones; (e) whether regulatory
authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (f) whether
RYTELO may cause, or have attributed to it, adverse events that could delay or prevent the commencement and/or
completion of clinical trials, impact its regulatory approval, or limit its commercial potential; (g) whether the IMpactMF
Phase 3 trial for relapsed/refractory myelofibrosis, or R/R MF, has a positive outcome and demonstrates safety and
effectiveness to the satisfaction of the FDA and international regulatory authorities, and whether our projected rates for
death events differ from actual rates, which may cause the planned interim and final analyses to occur later than
anticipated; (h) whether any future safety or efficacy results of RYTELO treatment cause its benefit-risk profile to become
unacceptable; (i) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the
malignant stem and progenitor cells of the underlying disease; (j) whether we meet our post-marketing requirements and
commitments for RYTELO; (k) whether there are failures or delays in manufacturing or supplying sufficient quantities of
RYTELO or other clinical trial materials that impact commercialization of RYTELO or the continuation of the IMpactMF
trial and other clinical trials; (l) whether we are able to establish and maintain effective sales, marketing and distribution
capabilities, obtain adequate coverage and third-party payor reimbursement, and achieve adequate acceptance in the
marketplace; (m) whether we are able to obtain and maintain the exclusivity terms and scopes provided by patent and
patent term extensions, regulatory exclusivity, and have freedom to operate; (n) that we may be unable to successfully
commercialize RYTELO due to competitive products, or otherwise; (o) that we may not be able to establish partnerships to
commercialize RYTELO in the international markets where RYTELO may be approved for marketing; (p) whether we
stay in compliance with and satisfy our obligations under our debt and synthetic royalty agreements; and (q) the impact of
general economic, industry or political climate in the U.S. or internationally and the effects of macroeconomic conditions
on our business and business prospects, financial condition and results of operations; as well as other risks that are
described herein and that are otherwise described from time to time in our Securities and Exchange Commission reports
including, but not limited to, the factors described in “Risk Factors,” in Part I, Item 1A of this Report. Geron assumes no
obligation for and except as required by law, disclaims any obligation to update these forward‑looking statements to reflect
future information, events or circumstances.
Below is a summary of material factors that make an investment in our common stock speculative or risky.
Importantly, this summary does not address all of the risks and uncertainties that we face. You should understand that it is
not possible to predict or identify all such factors. Consequently, you should not consider this summary to be a complete
discussion of all potential risks or uncertainties that may substantially impact our business. Additional discussion of the
risks and uncertainties summarized in this risk factor summary, as well as other risks and uncertainties that we face, can be
found under “Risk Factors” in Part I, Item 1A of this Report. The summary below is qualified in its entirety by that more
complete discussion of such risks and uncertainties. Moreover, we operate in a competitive and rapidly changing
environment. New factors emerge from time to time and it is not possible to predict the impact of all of these factors on our
business, financial condition or results of operations. You should consider carefully the risks and uncertainties described
under “Risk Factors” in Part I, Item 1A of this Report as part of your evaluation of an investment in our common stock.
Risks Related to the Commercialization of RYTELO® (Imetelstat)
Our near-term prospects are wholly dependent on RYTELO. We have limited experience
with the commercialization of RYTELO, and if we are unable to successfully
commercialize RYTELO in the U.S. for lower-risk MDS, or to expand its indication of use,
our ability to generate meaningful revenue or achieve profitability will be materially and
adversely affected.
Although we have established commercial operations and sales, marketing and distribution
infrastructure for RYTELO, we have limited experience in sustaining and scaling these
operations and our commercialization efforts may be unsuccessful or less successful than
anticipated.
If we are unable to continue to execute on our sales, marketing and distribution plans to
commercialize RYTELO, we may be unable to generate meaningful product revenue.
We face competition from existing products, product candidates and technologies, and
competitors may develop new products and technologies. If these products, product
candidates or technologies are deemed by the healthcare community to be superior to or
more cost-effective than RYTELO, it would significantly impact the development and
commercial viability of RYTELO, which would severely and adversely affect our financial
results, business and business prospects, and the future of RYTELO, and might cause us to
cease operations.
We will be subject to pricing and reimbursement regulations in the European Union, or EU,
which may materially affect our ability to commercialize and receive reimbursement
coverage for RYTELO in the EU.
Risks Related to Regulatory Approval of RYTELO
We may be unable to maintain regulatory approvals for RYTELO in the U.S. and the EU
for lower-risk MDS, which would severely and adversely affect our business and business
prospects, and might cause us to cease operations.
Our regulatory approval for RYTELO in the U.S. and in the EU for certain patients with
lower-risk MDS is subject to post-marketing requirements and commitments, and we may
be subject to penalties or product withdrawal if we fail to comply with these regulatory
requirements and commitments, or if we experience unanticipated problems with RYTELO.
Risks Related to Compliance with Healthcare Laws
Our relationships with healthcare providers, including physicians and third-party payors,
the methods by which we promote RYTELO, and the content of our promotional materials
and programs, are subject to applicable promotional, anti-kickback, fraud and abuse, and
other healthcare laws and regulations, and our failure to comply with these laws could
expose us to criminal sanctions, civil penalties, exclusion from federal health care
programs, contractual damages, reputational harm and may adversely affect our business
and financial results.
Risks Related to the Further Development of Imetelstat
We cannot be certain that we will be able to continue to develop imetelstat or advance it in
clinical trials, or that we will be able to receive regulatory approval for imetelstat in any
other indications in the U.S., the EU or any other region, on a timely basis or at all.
RYTELO may cause, or have attributed to it, undesirable or unintended side effects or other
adverse events that could halt or limit its further commercialization, delay or prevent its
regulatory approval in any other jurisdiction or indication, or cause us to delay or terminate
our clinical trials.
Results and data we disclosed from prior non-clinical studies and clinical trials, as well as
any data disclosed as a result of an interim analysis, may not predict success in later clinical
trials or the final analysis, and we cannot assure you that any ongoing or future clinical
trials of imetelstat, including IMpactMF, will lead to similar results and data that could
potentially enable us to obtain any further regulatory approvals.
Risks Related to Manufacturing RYTELO (Imetelstat)
Failure by us to maintain a manufacturing supply chain to appropriately and adequately
supply RYTELO for commercial and future clinical uses would adversely affect our ability
to commercialize RYTELO and result in a further delay in or cessation of clinical trials, and
our business and business prospects could be severely harmed, and we could cease
Risks Related to Our Operating Results, Financial Position and Need for Additional Capital
We have a history of net losses and may not achieve consistent future profitability for some
time, if ever.
Our failure to obtain additional capital, if and when needed, would force us to further delay,
reduce or eliminate the further development of RYTELO, or to halt the commercialization
of RYTELO, any of which would severely and adversely affect our financial results,
business and business prospects, and might cause us to cease operations.
Risks Related to Our Indebtedness and Royalty Payment Obligations
Our level of indebtedness and debt service obligations could adversely affect our financial
condition and may make it more difficult for us to fund our operations, including by
limiting our operating and financial flexibility.
Risks Related to Protecting Our Intellectual Property
If we are unable to obtain and maintain sufficient intellectual property protection and
relevant regulatory exclusivities for RYTELO, both in the U.S. and in other countries, our
competitors could develop and commercialize products similar or identical to RYTELO,
and our ability to successfully commercialize RYTELO may be adversely affected.
Risks Related to Managing Our Growth and Other Business Operations
Our strategic restructuring plan and the associated workforce reduction implemented in
December 2025 may not result in anticipated savings and long-term value creation, could
result in total costs and operating expenses that are greater than expected and could disrupt
our business.
We and certain of our current and former officers and directors have been named as
defendants in securities class action lawsuits and derivative lawsuits. These lawsuits, and
potential similar or related lawsuits, are costly to defend, could result in substantial
damages, divert management’s time and attention from our business, and have a material
adverse effect on our results of operations.
Calculation of Aggregate Market Value of Non‑Affiliate Shares
For purposes of calculating the aggregate market value of shares of our common stock held by
non‑affiliates as set forth on the cover page of this Report, we have assumed that all outstanding shares are held by
non‑affiliates, except for shares held directly or indirectly by each of our executive officers and directors. In the case of 5%
or greater stockholders, we have not deemed any such stockholders to be affiliates given the lack of facts and
circumstances that would indicate that any such stockholders exercise, or have the ability to exercise, any control over
Geron. These assumptions should not be deemed to constitute an admission that all executive officers and directors are, in
fact, affiliates of Geron, or that there are no other persons who may be deemed to be affiliates of Geron. Further
information concerning shareholdings of our executive officers, directors and principal stockholders is incorporated by
reference in Part III, Item 12 of this Report.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.