Geron (GERN) risk factors, FY2024 10-K

Risks Related to THE Commercialization of RYTELO

1. 01we may not be able to maintain adequate commercial supplies of RYTELO to meet demand or at an acceptable cost or at all
2. 02We have limited experience as a commercial company and our sales, marketing, and distribution of RYTELO may be unsuccessful or less successful than anticipated
3. 03If 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
4. 04If we do not obtain acceptable prices or adequate reimbursement for RYTELO, the use of RYTELO could be severely limited
5. 05To be commercially successful, RYTELO must be accepted by the healthcare community, which can be slow to adopt or unreceptive to new technologies and products
6. 06the willingness of patients to pay out-of-pocket in the absence of coverage by third-party payors, including governmental authorities
7. 07If the market opportunities for RYTELO are smaller than we believe, our revenue may be adversely affected, and our business may suffer
8. 08authorities, which would not permit us to market RYTELO for any other indications not expressly approved by those regulatory authorities. Future regulatory approvals for RYTELO, if any, could be conditioned upon label restrictions that materially limit the addressable patient population
9. 09We 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
10. 10We 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

RISKS RELATED TO REGULATORY APPROVAL OF RYTELO

1. 11We 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
2. 12delay or preclude any revenue we may receive from the future commercialization of RYTELO in any other jurisdictions or for any other indications, if any
3. 13If, 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
4. 14we may be required to change or stop ongoing clinical trials of RYTELO (imetelstat), which would negatively impact the development of RYTELO (imetelstat) for other potential indications
5. 15Our 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
6. 16We 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
7. 17RYTELO 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
8. 18We may experience additional risks related to operating outside of the U.S. that could materially adversely affect our business
9. 19business interruptions resulting from geopolitical actions, including war and terrorism
10. 20These and other risks associated with international operations may materially adversely affect our ability to attain or maintain profitable operations
11. 21Any 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., which could severely and adversely affect our business and business prospects

RISKS RELATED TO COMPLIANCE WITH HEALTHCARE LAWS

1. 22The 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
2. 23civil and criminal penalties and fines
3. 24curtailment of our operations

RISKS RELATED TO THE FURTHER DEVELOPMENT OF RYTELO (IMETELSTAT)

1. 25We 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
2. 26obtain, maintain and enforce adequate intellectual property and regulatory exclusivity for RYTELO in the U.S. and globally
3. 27Our 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
4. 28RYTELO 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
5. 29infusion-related reactions
6. 30RYTELO may not receive or maintain regulatory clearances and approvals required to enable its continued development
7. 31We 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)

1. 32regulatory acceptance and compliance with regulatory requirements, which are less well-defined for oligonucleotide products than for small molecule drugs and vary in each country
2. 33If 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
3. 34Each 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

Risks Related to Our OPERATING RESULTS AND Financial Position

1. 35We have a history of net losses and may not achieve consistent future profitability for some time, if ever
2. 36Our 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
3. 37expenditures we may incur to develop and/or commercialize any additional products, product candidates, or technologies that we may develop, in-license, or acquire
4. 38Our financial projections and estimates are subject to significant risks, assumptions, and uncertainties, and our actual results may differ materially
5. 39the costs of enabling our personnel to work remotely, including providing supplies, equipment and technology necessary for them to perform their responsibilities

Risks Related to our Indebtedness and ROYALTY PAYMENT OBLIGATIONS

1. 40Our 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
2. 41The terms of the Pharmakon Loan Agreement place restrictions on our operating and financial flexibility
3. 42We may not have cash available in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due
4. 43our assets are attached or seized
5. 44The Royalty Pharma Agreement places certain restrictions on our operational flexibility

Risks Related to Protecting Our Intellectual Property

1. 45Obtaining 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
2. 46Patent terms may be inadequate to protect our competitive position on RYTELO for an adequate amount of time
3. 47covering MDS and MF, and a SPC may only be applied to one patent. Accordingly, in countries of the EEA, we must rely on regulatory exclusivity and our method of treatment patents
4. 48The 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
5. 49Competitors 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
6. 50Changes 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
7. 51We 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
8. 52We 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
9. 53We have a registered trademark, RYTELO, for our product and failure to maintain such trademark could adversely affect our business
10. 54Much 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
11. 55or that our trade secrets will not otherwise become known or be independently discovered by competitors, any of which would harm our business significantly

Risks Related to Managing Our Growth and Other Business Operations

1. 56We 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
2. 57In 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
3. 58If 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
4. 59relinquish material rights, including revenue from commercialization, or assume material ongoing development obligations that we would have to fund or otherwise support
5. 60We have established subsidiaries in the United Kingdom and the Netherlands, which exposes us to additional costs and risks
6. 61workforce uncertainty in countries where labor unrest is more common than in the U.S
7. 62adverse effect on our business, and could cause us to limit or cease our commercialization and further development of RYTELO
8. 63We 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

1. 64If 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

Risks Related to Our Common Stock and Financial Reporting

1. 65Historically, our stock price has been extremely volatile and your investment may suffer a decline in value
2. 66Provisions 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
3. 67set forth procedures for nominating directors and submitting proposals for consideration at stockholders’ meetings
4. 68any claim or cause of action against us or any of our current or former directors, officers or other employees, or our stockholders, governed by the internal affairs doctrine or otherwise related to our internal affairs
5. 69We do not intend to pay cash dividends on our common stock in the foreseeable future
6. 70Our employees, independent contractors, principal investigators, clinical trial sites, contract research organizations, consultants or vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
7. 71Our business could be negatively impacted by environmental, social and corporate governance, or ESG, matters or our reporting of such matters
8. 72Failure 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
9. 73Changes 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
10. 74Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited