Immunome (IMNM) risk factors, FY2025 10-K

Risks Related to Our Business

1. 01We are a biopharmaceutical company with a history of losses. We expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability
2. 02We have a limited operating history, which may make it difficult to evaluate our drug development capabilities and predict our future performance79% rewritten
3. 03which are beyond our control. As a result, our stockholders should not rely upon the results of any quarterly or annual period as an indicator of future operating performanceNew
4. 04We have not yet submitted a New Drug Application, or NDA, or Biologics License Application, or BLA, obtained FDA approval for marketing, or successfully commercialized a product, and we may be unable to do soNew
5. 05We will need to raise substantial additional funds to advance development of our product candidates and our ADC platform, and we cannot guarantee that we will have sufficient funds available in the future to develop and commercialize any of our product candidates49% rewritten
6. 06our efforts to enhance operational systems, secure sufficient laboratory space and hire additional personnel, including personnel to support development of our programs and product candidates and satisfy our obligations as a public companyNew
7. 07additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividendsNew

Risks Related to Our Discovery, Development and Regulatory Approval of Programs and Product Candidates

1. 08We may be unable to advance any of our product candidates into and through clinical development, obtain regulatory approvals and ultimately commercialize them, or we could experience significant delays in doing so30% rewritten
2. 09the FDA or other regulatory agencies interpreting our data differently than we do or requiring us to conduct additional preclinical studies or clinical trialsNew
3. 10We may not be successful in our efforts to use and expand our ADC platform to build and progress a pipeline23% rewritten
4. 11We may pursue particular programs or product candidates over others; these decisions may prove to be wrong and may adversely impact our business
5. 12We may fail to realize the business benefits anticipated as a result of completed or future strategic transactions
6. 13Clinical trials are expensive, time-consuming and difficult to design and implement25% rewritten
7. 14having inadequate supply or quality of components, materials, diagnostics or other supplies necessary for the conduct of our preclinical studies or clinical trialsNew
8. 15If we encounter difficulties enrolling participants in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected56% rewritten
9. 16the risk that those enrolled in clinical trials will drop out of the trials before completionNew
10. 17The market may not be receptive to our product candidates, and we may not generate any revenue from their sale, partnering or licensing40% rewritten
11. 18availability of alternative effective treatments for the disease indications that our programs or product candidates are intended to treat and the relative risks, benefits and costs of those treatmentsNew
12. 19If the market opportunities for our product candidates are smaller than we believe they are, our future product revenues may be adversely affected, and our business may suffer
13. 20If we or others identify undesirable side effects caused by any of our current or future product candidates undergoing clinical trials, our ability to market and derive revenue from the product candidate could be compromised82% rewritten
14. 21claims. Any of these occurrences may materially and adversely affect our business and financial condition and impair our ability to generate revenuesNew
15. 22we may be sued, subject to fines, injunctions or the imposition of civil or criminal penalties; andNew
16. 23Our IM-3050 program may face additional and potentially unpredictable challenges36% rewritten
17. 24due to the short half-life of Lu-177, we may incur significant expense developing the means required to effectively and timely distribute drug products to clinical sites and, if approved, to sites for administration to participantsNew
18. 25A Fast Track Designation from the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive regulatory approval36% rewritten
19. 26an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefitNew
20. 27We may fail to obtain orphan drug designations for our product candidates, and even if we obtain such designations, we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity
21. 28Additional regulatory burdens and other risks and uncertainties in foreign markets may limit our growth
22. 29Our business entails a significant risk of product liability, which may not be sufficiently covered by our insurance
23. 30We have obtained rights to use human samples in furtherance of our research and development. However, if we failed to obtain appropriate permission to use these samples or exceed the scope of the permissions given, our programs could be adversely affected

Risks Related to Government Regulation

1. 31laws govern the data privacy and security of personal information and data in specified circumstances, are often not pre-empted by HIPAA, and may have a more prohibitive effect than HIPAA, thus complicating compliance effortsNew
2. 32Health care legislative, regulatory and administrative reform measures, as well as changes or instability at government agencies including FDA, may have a material adverse effect on our business and results of operationsNew
3. 33credits, set to expire at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insuranceNew
4. 34If we or our existing or potential future partners, manufacturers or other service providers fail to comply with health care laws and regulations, we or they could be subject to enforcement actions, which could affect our ability to develop, market and sell our products and may harm our reputation
5. 35Any programs or product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated
6. 36Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements32% rewritten
7. 37consent decrees, corporate integrity agreements, debarment, or exclusion from federal health care programs; or mandated modification of promotional materials and labeling and the issuance of corrective informationNew
8. 38Even if we are able to commercialize any program or product candidate, the program and product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business68% rewritten
9. 39products. If the price we are able to charge for any products we develop, or the payments provided for such products, is inadequate in light of our development and other costs, our return on investment could be adversely affectedNew
10. 40they have been approved by the FDA and meet other requirements of the statuteNew
11. 41We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal or civil liability and harm our business

Risks Related to Strategic Transactions, Manufacturing, Commercialization and Reliance on Third Parties

1. 42commercialization of our product candidates and have a negative impact on the competitiveness of any program or product candidate that reaches marketNew
2. 43Because we rely on third parties for manufacturing, supply and testing, some of which may be sole source vendors, for preclinical and clinical development materials and commercial supplies, our supply may become limited or interrupted or may not be of satisfactory quantity or quality46% rewritten
3. 44We may be unable to successfully scale manufacturing in sufficient quality and quantity, which would delay or prevent us from completing our development and commercialization efforts, if any
4. 45Our significant reliance on third-party vendors could impair our ability to implement our business plan
5. 46In the ordinary course of our business, we and the third parties with whom we work process proprietary, confidential, and other sensitive information, including our clinical trial data, health-related data and personal information, or collectively, sensitive data
6. 47Remote work has increased risks to our information technology systems and data, as more of our personnel utilize network connections, computers and devices outside our premises or network, including working at home, while in transit and in public locations
7. 48Further, some of our contracts do not contain limitations of liability, and even where they do, there can be no assurance that such limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations
8. 49Our current laboratory operations are concentrated in one location, and we and the third parties upon whom we depend may be adversely affected by natural or other disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster

Risks Related to Our Intellectual Property

1. 50It is difficult and costly to protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection
2. 51we may not develop additional proprietary technologies or targeted therapeutics that are separately patentableNew
3. 52Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
4. 53Patent terms may not be able to protect our competitive position for an adequate period of time with respect to our current or future targeted therapeutics
5. 54Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current or any future targeted therapeutics
6. 55We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business42% rewritten
7. 56property and proprietary rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or in-licenseNew
8. 57In order to protect our competitive position around our future products, we may become involved in lawsuits to enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful and which may result in our patents being found invalid or unenforceable
9. 58A third party may hold intellectual property, including patent rights, that are important or necessary to the development of our targeted therapeutics. It may be necessary for us to use the patented or proprietary technology of one or more third parties to commercialize our current and future targeted therapeutics
10. 59If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected targeted therapeutics
11. 60We are reliant upon in-licenses to certain patent rights and proprietary technologies from third parties that are or may become important or necessary to our targeted therapeutics pipeline
12. 61Under our current and future license agreements, we may not have all intellectual property rights necessary for developing, commercializing, and protecting our current or future targeted therapeutics
13. 62Intellectual property rights of third parties could adversely affect our ability to commercialize our targeted therapeutics, and we might be required to obtain licenses from third parties to engage in development or marketing efforts, which may not be available on commercially reasonable terms or at all70% rewritten
14. 63be brought, we may be required to pay substantial damages or be forced to abandon our current or future targeted therapeutics or to seek a license from any patent holders. No assurances can be given that a license will be available on commercially reasonable terms, if at allNew
15. 64Others may challenge inventorship or claim an ownership interest in our intellectual property which could expose us to litigation and have a significant adverse effect on our prospects
16. 65If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
17. 66We may be subject to claims by third parties that we or our employees or consultants have wrongfully used or disclosed their alleged trade secrets or other proprietary information
18. 67If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
19. 68Intellectual property rights do not necessarily address all potential threats to our business

Risks Related to Our Business Operations and Industry

1. 69Any inability to attract and retain qualified key management, technical personnel and employees would impair our ability to implement our business plan. In addition, prior successes of our personnel may not be indicative of our future success
2. 70In addition, although our leadership team and other key personnel previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, no assurance can be given that their prior successes will be indicative of our future success
3. 71We may experience difficulties in managing our growth and expanding our operations27% rewritten
4. 72Our employees, principal investigators, vendors and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements

Risks Related to our Common Stock

1. 73An active trading market for our common stock may not be sustained, which may make it difficult for you to sell your shares
2. 74The market price of our common stock is expected to be volatile, and purchasers of our common stock could incur substantial losses
3. 75Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of our common stock
4. 76Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval
5. 77Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall21% rewritten
6. 78Our ability to use net operating loss carryforwards and other tax attributes may be limited
7. 79Capital appreciation, if any, will be a stockholder’s sole source of gain
8. 80Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management76% rewritten
9. 81the authority of the board of directors to issue preferred stock with such terms as the board of directors may determineNew
10. 82We could be subject to securities class action litigation or stockholder derivative litigation
11. 83Unfavorable global economic and political conditions, including tariffs and trade barriers, could adversely affect our business, financial condition or results of operations45% rewritten
12. 84Future changes in financial accounting standards or practices may cause adverse and unexpected revenue fluctuations and adversely affect our reported results of operations
13. 85Changes in tax laws or regulations that are applied adversely to us or our vendors or collaborators may have a material adverse effect on our business, cash flow, financial condition or results of operations43% rewritten
14. 86If we are unable to maintain an effective system of disclosure controls and internal control over financial reporting, our ability to produce timely and accurate financial statements or comply with applicable regulations could be impaired
15. 87Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
16. 88We incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to public company reporting and compliance initiatives23% rewritten
17. 89If securities or industry analysts publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline
18. 90If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected