Geron (GERN) FY2025 10-K Risk Factors: 20 New, 14 Dropped

What the changes say

RYTELO is now approved in the EU, adding EU commercialization, reimbursement, orphan-exclusivity, and regulatory risks.

What changed since the prior 10-K

New

NewRISKS RELATED TO THE COMMERCIALIZATION OF RYTELO
Therefore, coverage and adequate reimbursement are critical to market acceptance of RYTELO
NewRISKS RELATED TO THE COMMERCIALIZATION OF RYTELO
Future regulatory approvals for RYTELO, if any, could be conditioned upon label restrictions that materially limit the addressable patient population
NewRISKS RELATED TO REGULATORY APPROVAL OF RYTELO
Similar requirements and related consequences apply outside the U.S
NewRISKS RELATED TO REGULATORY APPROVAL OF RYTELO
Failure to obtain approval could significantly harm our business and business prospects, render our significant clinical development expenditures unrecoverable, and might cause us to cease operations
NewRISKS RELATED TO REGULATORY APPROVAL OF RYTELO
Any marketing approval that we may receive for RYTELO in any other jurisdiction or for any other indication may also be limited or subject to restrictions or post-approval commitments and requirements that increase our costs or render RYTELO not commercially viable, which would harm our business and business prospects
NewRISKS RELATED TO REGULATORY APPROVAL OF RYTELO
Similarly, in the EU, orphan market exclusivity may not effectively protect RYTELO from all competition
NewRISKS RELATED TO COMPLIANCE WITH HEALTHCARE LAWS
Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws
NewRISKS RELATED TO THE FURTHER DEVELOPMENT OF IMETELSTAT
Top-line or interim results and data may differ from future results of the same study, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated
NewRISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY
Additionally, there are regulations for the listing of patents in the Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. Some of our patents have been listed in the Orange Book
NewRISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY
Such disputes could impair our ability to obtain patent protection or protect our proprietary information, which, in either case, could have a significant impact on our business
NewRISKS 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
NewRISKS RELATED TO MANAGING OUR GROWTH AND OTHER BUSINESS OPERATIONS
Management transition creates uncertainties and could harm our business
NewRISKS RELATED TO MANAGING OUR GROWTH AND OTHER BUSINESS OPERATIONS
Securities class action lawsuits and/or derivative lawsuits have often been brought against companies, including biotechnology and biopharmaceutical companies, that experience volatility in the market price of their securities
NewRISKS RELATED TO MANAGING OUR GROWTH AND OTHER BUSINESS OPERATIONS
3:25-cv-03356, Lerner v
NewRISKS RELATED TO MANAGING OUR GROWTH AND OTHER BUSINESS OPERATIONS
and Willis v
NewRISKS RELATED TO INFORMATION TECHNOLOGY SYSTEMS, DATA SECURITY AND DATA PRIVACY
We and third parties with whom we work are subject to stringent and changing U.S. and foreign laws, regulations, rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security
NewRISKS RELATED TO INFORMATION TECHNOLOGY SYSTEMS, DATA SECURITY AND DATA PRIVACY
Our (or the third parties with whom we work) actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue and profits; and other adverse business impacts
NewRISKS RELATED TO INFORMATION TECHNOLOGY SYSTEMS, DATA SECURITY AND DATA PRIVACY
Our employees and personnel use generative AI technologies to perform their work, and the disclosure and use of personal data in generative AI technologies is subject to various privacy laws and other privacy obligations
NewRISKS RELATED TO OUR COMMON STOCK AND FINANCIAL REPORTING
As a result, the market price of our common stock may be adversely affected
NewRISKS RELATED TO OUR COMMON STOCK AND FINANCIAL REPORTING
Therefore, we cannot assure you that additional material weaknesses or significant deficiencies will not exist or otherwise be discovered in the future, particularly in light of our increased reliance on personnel working remotely

Dropped

DroppedRisks Related to THE Commercialization of RYTELO
We have limited experience as a commercial company and our sales, marketing, and distribution of RYTELO may be unsuccessful or less successful than anticipated
DroppedRisks Related to THE Commercialization of RYTELO
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
DroppedRISKS RELATED TO REGULATORY APPROVAL OF RYTELO
If, and to the extent that, we are unable to comply with these regulations, our ability to earn revenue from the commercialization of RYTELO will be materially and adversely impacted
DroppedRISKS RELATED TO REGULATORY APPROVAL OF RYTELO
Our regulatory approval for RYTELO in the U.S. for 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
DroppedRISKS RELATED TO REGULATORY APPROVAL OF RYTELO
RYTELO and affect reimbursement by third-party payors. Future regulatory clearances, if any, may be limited to a smaller patient population, or may require a different drug formulation or a different manufacturing process, than we might in the future decide to seek
DroppedRISKS RELATED TO REGULATORY APPROVAL OF RYTELO
These and other risks associated with international operations may materially adversely affect our ability to attain or maintain profitable operations
DroppedRISKS RELATED TO COMPLIANCE WITH HEALTHCARE LAWS
The FDA, DOJ and other regulatory authorities actively enforce regulations related to the promotion and advertisement of pharmaceutical products, and if we were found to have violated the Food, Drug and Cosmetic Act, we could be subject to significant civil, criminal and administrative penalties
DroppedRISKS RELATED TO COMPLIANCE WITH HEALTHCARE LAWS
The adoption of health policy changes and healthcare reform both in the U.S. and outside the U.S. may adversely affect our business and financial results
DroppedRISKS RELATED TO THE FURTHER DEVELOPMENT OF RYTELO (IMETELSTAT)
RYTELO may not receive or maintain regulatory clearances and approvals required to enable its continued development
DroppedRisks Related to Our OPERATING RESULTS AND Financial Position
Our operating results are unpredictable and may fluctuate. If our operating results are below the expectations of securities analysts or investors, the trading price of our common stock could decline
DroppedRisks Related to our Indebtedness and ROYALTY PAYMENT OBLIGATIONS
The terms of the Pharmakon Loan Agreement place restrictions on our operating and financial flexibility
DroppedRISKS RELATED TO INFORMATION TECHNOLOGY SYSTEMS, DATA SECURITY AND DATA PRIVACY
If we fail to successfully implement or upgrade our enterprise resource planning and other information systems, our business and results of operation could be adversely impacted
DroppedRisks Related to Our Common Stock and Financial Reporting
Our business could be negatively impacted by environmental, social and corporate governance, or ESG, matters or our reporting of such matters
DroppedRisks Related to Our Common Stock and Financial Reporting
Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations

Reworded

87% rewrittenRISKS RELATED TO MANAGING OUR GROWTH AND OTHER BUSINESS OPERATIONS
We may experience additional risks related to operating outside of the U.S. that could materially adversely affect our business
85% rewrittenRISKS RELATED TO OUR COMMON STOCK AND FINANCIAL REPORTING
Provisions in our charter, bylaws and Delaware law may inhibit potential acquisition bids for us, which may adversely affect the market price of our common stock and/or prevent holders of our common stock from benefiting from what they believe may be the positive aspects of acquisitions and takeovers
84% rewrittenRISKS RELATED TO THE COMMERCIALIZATION OF RYTELO
If the market opportunities for RYTELO are smaller than we believe, our revenue may be adversely affected, and our business may suffer
84% rewrittenRISKS 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
Was: We may be unable to maintain regulatory approval for RYTELO in the U.S. for lower-risk MDS, which would severely and adversely affect our business and business prospects, and might cause us to cease operations
84% rewrittenRISKS RELATED TO THE COMMERCIALIZATION OF RYTELO
If we do not maintain acceptable prices or adequate reimbursement for RYTELO, the use of RYTELO could be severely limited
Was: If we do not obtain acceptable prices or adequate reimbursement for RYTELO, the use of RYTELO could be severely limited
83% rewrittenRISKS RELATED TO REGULATORY APPROVAL OF RYTELO
We may be unable to obtain regulatory approval to commercialize RYTELO in any other jurisdictions or for any new indications, or may experience significant delays in doing so, any of which could severely and adversely affect our business and business prospects, and might cause us to cease operations
81% rewrittenRISKS RELATED TO MANAGING OUR GROWTH AND OTHER BUSINESS OPERATIONS
We have established subsidiaries in the United Kingdom and the Netherlands, which exposes us to additional costs and risks
79% rewrittenRISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY
Much of the information and know-how that is critical to our business is not patentable, and we may not be able to prevent others from obtaining this information and establishing competitive enterprises
79% rewrittenRISKS RELATED TO OUR OPERATING RESULTS AND FINANCIAL POSITION
We have a history of net losses and may not achieve consistent future profitability for some time, if ever
69% rewrittenRISKS RELATED TO OUR COMMON STOCK AND FINANCIAL REPORTING
Historically, our stock price has been extremely volatile and your investment may suffer a decline in value
67% rewrittenRISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY
We have a registered trademark, RYTELO, for our product and failure to maintain such trademark could adversely affect our business
65% rewrittenRISKS RELATED TO THE COMMERCIALIZATION OF RYTELO
We will be subject to pricing and reimbursement regulations in the EU, which may materially affect our ability to commercialize and receive reimbursement coverage for RYTELO in the EU
Was: We are seeking regulatory approval to commercialize RYTELO in the EU, and any such approval, if received, will be subject to pricing, drug marketing, post-market and reimbursement regulations in the EU, which may materially affect our ability to commercialize and receive reimbursement coverage for RYTELO in the EU
65% rewrittenRISKS RELATED TO OUR COMMON STOCK AND FINANCIAL REPORTING
Failure to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on our business and stock price
Was: Failure to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on our business and stock price
64% rewrittenRISKS RELATED TO THE FURTHER DEVELOPMENT OF IMETELSTAT
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
56% rewrittenRISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY
Changes in U.S. or international patent law or interpretations of such patent laws could diminish the value of our patents in general, thereby impairing our ability to protect our technologies and RYTELO
52% rewrittenRISKS RELATED TO OUR INDEBTEDNESS AND ROYALTY PAYMENT OBLIGATIONS
The Royalty Pharma Agreement places certain restrictions on our operational flexibility
48% rewrittenRISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY
Patent terms may be inadequate to protect our competitive position on RYTELO for an adequate amount of time
45% rewrittenRISKS RELATED TO MANAGING OUR GROWTH AND OTHER BUSINESS OPERATIONS
Although we intend to establish potential future collaborative arrangements for RYTELO, we may be unable to establish such collaborative arrangements on acceptable terms, or at all, and may have to delay, alter or abandon commercialization or further development of RYTELO
Was: If we seek to establish potential future collaborative arrangements for RYTELO, we may be unable to establish such collaborative arrangements on acceptable terms, or at all, and may have to delay, alter or abandon commercialization or further development of RYTELO
43% rewrittenRISKS RELATED TO MANUFACTURING RYTELO (IMETELSTAT)
If third parties that manufacture RYTELO fail to perform as needed, the commercial and clinical supply of RYTELO could be interrupted or limited, and we may be unable to successfully commercialize RYTELO or conduct or complete current or potential future clinical trials
41% rewrittenRISKS RELATED TO THE COMMERCIALIZATION OF RYTELO
To be commercially successful, RYTELO must be accepted by the healthcare community, which can be slow to adopt or unreceptive to new technologies and products
31% rewrittenRISKS 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
Was: We cannot be certain that we will be able to continue to develop RYTELO or advance it in clinical trials, or that we will be able to receive regulatory approval for RYTELO in any other indications in the U.S., the EU or any other region, on a timely basis or at all
26% rewrittenRISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY
The validity, scope and enforceability of any patents listed in the Orange Book that cover RYTELO or its methods of use can be challenged by third parties and may not protect us from generic or innovator competition
25% rewrittenRISKS RELATED TO MANUFACTURING RYTELO (IMETELSTAT)
Each of these risks could lead to delays or shortages in drug supply, or the inability to manufacture or ship drug supply necessary for commercialization, and non-clinical and clinical activities, which could severely and adversely affect our financial results, business and business prospects
25% rewrittenRISKS 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
Was: 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
24% rewrittenRISKS RELATED TO THE FURTHER DEVELOPMENT OF IMETELSTAT
Our clinical trials of imetelstat could be interrupted, delayed, terminated or abandoned for a variety of reasons which could severely and adversely affect our financial results, business and business prospects
23% rewrittenRISKS RELATED TO OUR OPERATING RESULTS AND FINANCIAL POSITION
Our financial projections and estimates are subject to significant risks, assumptions, and uncertainties, and our actual results may differ materially

All 60 risk factors

Headings as the filing states them, in filing order.

RISKS RELATED TO THE COMMERCIALIZATION OF RYTELO

01If we do not maintain acceptable prices or adequate reimbursement for RYTELO, the use of RYTELO could be severely limited84% rewritten
02Therefore, coverage and adequate reimbursement are critical to market acceptance of RYTELONew
03To be commercially successful, RYTELO must be accepted by the healthcare community, which can be slow to adopt or unreceptive to new technologies and products41% rewritten
04If the market opportunities for RYTELO are smaller than we believe, our revenue may be adversely affected, and our business may suffer84% rewritten
05Future regulatory approvals for RYTELO, if any, could be conditioned upon label restrictions that materially limit the addressable patient populationNew
06We rely on a select network of third party distributors, specialty pharmacies and other vendors to distribute RYTELO in the U.S., and any failure by such distributors, specialty pharmacies and vendors could adversely affect our revenues, financial condition, or results of operations
07We will be subject to pricing and reimbursement regulations in the EU, which may materially affect our ability to commercialize and receive reimbursement coverage for RYTELO in the EU65% rewritten

RISKS RELATED TO REGULATORY APPROVAL OF RYTELO

08We 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 operations84% rewritten
09Similar requirements and related consequences apply outside the U.SNew
10We may be unable to obtain regulatory approval to commercialize RYTELO in any other jurisdictions or for any new indications, or may experience significant delays in doing so, any of which could severely and adversely affect our business and business prospects, and might cause us to cease operations83% rewritten
11Failure to obtain approval could significantly harm our business and business prospects, render our significant clinical development expenditures unrecoverable, and might cause us to cease operationsNew
12Any marketing approval that we may receive for RYTELO in any other jurisdiction or for any other indication may also be limited or subject to restrictions or post-approval commitments and requirements that increase our costs or render RYTELO not commercially viable, which would harm our business and business prospectsNew
13Similarly, in the EU, orphan market exclusivity may not effectively protect RYTELO from all competitionNew
14Any of these events may result in a failure to further develop, obtain regulatory approval for or commercialize RYTELO in any jurisdiction or in any indication other than lower-risk MDS in the U.S. and the EU, which could severely and adversely affect our business and business prospects

RISKS RELATED TO COMPLIANCE WITH HEALTHCARE LAWS

15Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such lawsNew

RISKS RELATED TO THE FURTHER DEVELOPMENT OF IMETELSTAT

16We 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 all31% rewritten
17Our clinical trials of imetelstat could be interrupted, delayed, terminated or abandoned for a variety of reasons which could severely and adversely affect our financial results, business and business prospects24% rewritten
18RYTELO 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 trials64% rewritten
19Top-line or interim results and data may differ from future results of the same study, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluatedNew
20We rely on third parties to conduct our current and potential future clinical trials of imetelstat. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to continue the development of imetelstat

RISKS RELATED TO MANUFACTURING RYTELO (IMETELSTAT)

21If third parties that manufacture RYTELO fail to perform as needed, the commercial and clinical supply of RYTELO could be interrupted or limited, and we may be unable to successfully commercialize RYTELO or conduct or complete current or potential future clinical trials43% rewritten
22Each of these risks could lead to delays or shortages in drug supply, or the inability to manufacture or ship drug supply necessary for commercialization, and non-clinical and clinical activities, which could severely and adversely affect our financial results, business and business prospects25% rewritten

RISKS RELATED TO OUR OPERATING RESULTS AND FINANCIAL POSITION

23We have a history of net losses and may not achieve consistent future profitability for some time, if ever79% rewritten
24Our financial projections and estimates are subject to significant risks, assumptions, and uncertainties, and our actual results may differ materially23% rewritten

RISKS RELATED TO OUR INDEBTEDNESS AND ROYALTY PAYMENT OBLIGATIONS

25Our 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 flexibility25% rewritten
26We may not have cash available in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due
27The Royalty Pharma Agreement places certain restrictions on our operational flexibility52% rewritten

RISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY

28Obtaining and maintaining our patent rights depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements
29Patent terms may be inadequate to protect our competitive position on RYTELO for an adequate amount of time48% rewritten
30Additionally, there are regulations for the listing of patents in the Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. Some of our patents have been listed in the Orange BookNew
31The validity, scope and enforceability of any patents listed in the Orange Book that cover RYTELO or its methods of use can be challenged by third parties and may not protect us from generic or innovator competition26% rewritten
32Changes in U.S. or international patent law or interpretations of such patent laws could diminish the value of our patents in general, thereby impairing our ability to protect our technologies and RYTELO56% rewritten
33Competitors may infringe, misappropriate or otherwise violate our patents or other intellectual property rights. To counter infringement or unauthorized use, we may be required to file and prosecute legal claims against one or more third parties, which can be expensive and time-consuming, even if ultimately successful
34We may not be able to protect our intellectual property rights in the U.S or worldwide and challenges to our owned or licensed patent rights would result in costly and time-consuming legal proceedings that could prevent or limit development or commercialization of RYTELO
35We may be subject to infringement claims that are costly to defend, and such claims may limit our ability to use disputed technologies and prevent us from pursuing research, development, manufacturing or commercialization of RYTELO
36We have a registered trademark, RYTELO, for our product and failure to maintain such trademark could adversely affect our business67% rewritten
37Such disputes could impair our ability to obtain patent protection or protect our proprietary information, which, in either case, could have a significant impact on our businessNew
38Much of the information and know-how that is critical to our business is not patentable, and we may not be able to prevent others from obtaining this information and establishing competitive enterprises79% rewritten

RISKS RELATED TO MANAGING OUR GROWTH AND OTHER BUSINESS OPERATIONS

39Our 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 businessNew
40We may be unable to successfully retain or recruit key personnel to support the commercialization and further development of RYTELO or to otherwise successfully manage our growth
41In addition, our personnel are currently performing their duties in multiple jurisdictions, and if we are unable or fail to comply with employment, tax, benefits and other laws in such jurisdictions, we may face penalties, fines or litigation
42Management transition creates uncertainties and could harm our businessNew
43Although we intend to establish potential future collaborative arrangements for RYTELO, we may be unable to establish such collaborative arrangements on acceptable terms, or at all, and may have to delay, alter or abandon commercialization or further development of RYTELO45% rewritten
44We have established subsidiaries in the United Kingdom and the Netherlands, which exposes us to additional costs and risks81% rewritten
45We may experience additional risks related to operating outside of the U.S. that could materially adversely affect our business87% rewritten
46Securities class action lawsuits and/or derivative lawsuits have often been brought against companies, including biotechnology and biopharmaceutical companies, that experience volatility in the market price of their securitiesNew
473:25-cv-03356, Lerner vNew
48and Willis vNew
49We may be subject to third-party litigation, and such litigation would be costly to defend or pursue and uncertain in its outcome

RISKS RELATED TO INFORMATION TECHNOLOGY SYSTEMS, DATA SECURITY AND DATA PRIVACY

50We and third parties with whom we work are subject to stringent and changing U.S. and foreign laws, regulations, rules, contractual obligations, industry standards, policies and other obligations related to data privacy and securityNew
51Our (or the third parties with whom we work) actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue and profits; and other adverse business impactsNew
52Our employees and personnel use generative AI technologies to perform their work, and the disclosure and use of personal data in generative AI technologies is subject to various privacy laws and other privacy obligationsNew

RISKS RELATED TO OUR COMMON STOCK AND FINANCIAL REPORTING

53Historically, our stock price has been extremely volatile and your investment may suffer a decline in value69% rewritten
54Provisions in our charter, bylaws and Delaware law may inhibit potential acquisition bids for us, which may adversely affect the market price of our common stock and/or prevent holders of our common stock from benefiting from what they believe may be the positive aspects of acquisitions and takeovers85% rewritten
55As a result, the market price of our common stock may be adversely affectedNew
56We do not intend to pay cash dividends on our common stock in the foreseeable future
57Our employees, independent contractors, principal investigators, clinical trial sites, CROs, consultants or vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
58Failure to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on our business and stock price65% rewritten
59Therefore, we cannot assure you that additional material weaknesses or significant deficiencies will not exist or otherwise be discovered in the future, particularly in light of our increased reliance on personnel working remotelyNew
60Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited

Other Geron 10-Ks

FY2024 10-K risk factors
74 risks
Geron is a commercial-stage biopharmaceutical company wholly dependent on the success of its sole approved product, RYTELO (imetelstat). The company faces major risks regarding sales execution, manufacturing supply chains, reimbursement, and heavy indebtedness under its Pharmakon loan.
Filed Feb 27, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.