Verastem (VSTM) risk factors, FY2025 10-K

Risks Related to the Development of Our Product Candidates and Commercialization of our Product Candidates

1. 01Ø We are highly dependent on the commercial success of AVMAPKI FAKZYNJA CO-PACK (avutometinib capsules; defactinib tablets) in the U.S for the foreseeable futureNew
2. 02a continued acceptable safety and efficacy profile of the products following approvalNew
3. 03Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must complete extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humansNew
4. 04A failure of one or more clinical trials could indicate a higher likelihood that subsequent clinical trials of the same product candidate in the same or other indications or subsequent clinical trials of other related product candidates will be unsuccessful for the same reasons as the unsuccessful clinical trials
5. 05Ø If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented
6. 06Research on the use of small molecules to cause cell death, inhibition of tumor growth, and disruption of the tumor microenvironment is an emerging field and, consequently, there is still uncertainty about whether defactinib, avutometinib and VS-7375 are effective in improving outcomes for patients with cancer
7. 07Ø The market opportunities for AVMAPKI FAKZYNJA CO-PACK and our other product candidates, if approved, may be smaller than we estimate, and the FDA and other comparable foreign regulatory authorities may approve our product candidates for a more limited patient population than we anticipate
8. 08Ø We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do
9. 09Ø If we fail to obtain regulatory approval in jurisdictions outside the U.S., we will not be able to market our products in those jurisdictions
10. 10Ø If serious adverse or unexpected side effects are identified during the development of our product candidates, we may need to abandon or limit our development of some of our product candidates62% rewritten
11. 11Ø We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
12. 12Ø Any future product candidates that we commercialize may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business
13. 13Ø Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may developNew
14. 14Ø A pandemic, epidemic, or outbreak of an infectious disease, such as COVID-19, has and may in the future adversely affect our business

Risks Related to Our Commercial Agreements

1. 15Ø Our ability to receive future contingent consideration, including milestone payments and royalties, from the sale of our rights, title, and interest in COPIKTRA to Secura may be adversely affected by lower than expected COPIKTRA sales and Secura’s ability to achieve other developmental and regulatory milestones
2. 16Ø If we do not realize the anticipated benefits of our license agreements with Pfizer for the FAK program and Chugai for the dual RAF/MEK candidate program, or from the GenFleet Agreement, our business could be adversely affected
3. 17Ø We depend on GenFleet to fully perform under the GenFleet Agreement inclusive of our supply agreement with GenFleet

Risks Related to Our Financial Position and Need for Additional Capital

1. 18Ø We have incurred significant losses since our inception. We may incur losses for the foreseeable future and may never achieve or maintain profitability25% rewritten
2. 19Ø We will need additional funding. If we are unable to raise capital if needed, we would be forced to delay, reduce, or eliminate our product development programs or commercialization efforts, including for avutometinib, defactinib and VS-737549% rewritten
3. 20Ø Unfavorable economic conditions could have a material adverse effect on our business, financial condition, results of operations, or cash flows47% rewritten
4. 21Ø Our ability to use our net operating loss carryforwards may be limited23% rewritten

Risks Related to Our Indebtedness

1. 22Ø 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 operations90% rewritten
2. 23ii. at our option, the, a third purchase of up to $50.0 million principal amount of Notes, at any time prior to December 31, 2026, provided that trailing six-month worldwide net sales of avutometinib and defactinib are at least $55.0 million and subject to certain other customary conditions precedentNew
3. 24Ø We may not have cash available in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due

Risks Related to Our Dependence on Third Parties

1. 25Ø We rely in part on third parties to conduct our clinical trials and preclinical testing, and if they do not properly and successfully perform their obligations to us, we may not be able to obtain regulatory approvals for and commercialize any of our other product candidates
2. 26Any of these third parties may terminate their engagements with us at any time. If we need to enter into alternative arrangements, it would delay our product development activities and ultimately the commercialization of our product candidates
3. 27Ø We rely on third parties to conduct investigator-sponsored clinical trials of our product candidates. Any failure by a third party to meet its obligations with respect to the clinical development of our product candidates may delay or impair our ability to obtain regulatory approval for our product candidates
4. 28Ø We contract with third parties for the manufacture of our products and product candidates and for compound formulation research, and these third parties may not perform satisfactorily
5. 29Ø If we are not able to establish additional collaborations, we may have to alter our development and commercialization plans
6. 30Ø We may not realize the benefits of our current or future collaborations or licensing arrangements with third parties for the development and commercialization of our product candidates and may be unsuccessful in consummating future partnerships or capitalizing on the market potential of our product candidates
7. 31Ø Our operations in foreign jurisdictions, and those of third parties for which we rely on, may be impacted by economic, political and social conditions in such jurisdictions

Risks Related to Our Intellectual Property

1. 32Ø If we fail to comply with our obligations under our intellectual property licenses with third parties, we could lose license rights that are important to our business
2. 33commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to oursNew
3. 34Ø If our efforts to protect the proprietary nature of the intellectual property related to our products are not adequate, we may not be able to compete effectively in our market24% rewritten
4. 35that the claims in any of our issued patents will be considered valid or patentable by courts in the U.S. or foreign countriesNew
5. 36Ø We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses
6. 37foreign regulatory authorities. All product candidates are prone to risks of failure typical of pharmaceutical product developmentNew
7. 38Ø Obtaining and maintaining our patent protection 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 non-compliance with these requirements
8. 39Ø Issued patents covering our products could be found invalid or unenforceable if challenged in court or the USPTO
9. 40Ø Changes to patent law in the U.S. and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products
10. 41Ø We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world21% rewritten
11. 42Ø If we do not obtain patent term extension and data exclusivity for any of our current products, our business may be materially harmed
12. 43Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time consuming
13. 44Ø Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business
14. 45Ø We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
15. 46Ø We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
16. 47Ø Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
17. 48Ø If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
18. 49Ø If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest, and our business may be adversely affected
19. 50Ø European patents and patent applications could be challenged in the recently created Unified Patent Court for the European Union

Risks Related to Achieving Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters

1. 51Ø If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for our product candidates, we will not be able to commercialize such candidates, and our ability to generate revenue will be materially impaired27% rewritten
2. 52Ø We have received orphan drug designation for certain of our product candidates, but there can be no assurance that we will be able to prevent third parties from developing and commercializing products that are competitive to these product candidates26% rewritten
3. 53approval or contain requirements for costly post marketing testing and surveillance to monitor the safety or efficacy of the product, including the imposition of a REMSNew
4. 54Ø Current and future health care reforms may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain79% rewritten
5. 55Healthcare reform efforts have been and may continue to be subject to scrutiny, legal challenge and subsequent amendment, creating further uncertaintyNew
6. 56Ø If we fail to comply with our obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to penalties and sanctions, which could have a material adverse effect on our business, financial condition, results of operations, and future prospectsNew
7. 57Ø Disruptions at the FDA and other government agencies caused by funding shortages could prevent our product candidates from being developed, approved, or commercialized in a timely manner, or at all, which could negatively impact our business
8. 58Ø We face uncertainty regarding potential regulatory developments that may adversely affect our business

Risks Related to Employee Matters and Managing Growth

1. 59Ø Our future success depends on our ability to retain our chief executive officer and other key executives and to attract, retain and motivate qualified personnel
2. 60Ø We may expand our development, regulatory and future sales and marketing capabilities over time, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
3. 61Ø Our business and operations may be materially adversely affected in the event of computer system breaches or failures

Risks Related to Our Capital Stock

1. 62Ø Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management
2. 63Ø The market price of our common stock has been, and may continue to be, highly volatile
3. 64Ø Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the source of gain for our stockholders
4. 65Ø We can issue and have issued shares of preferred stock, which may adversely affect the rights of holders of our common stock73% rewritten
5. 66Ø Our stockholders will experience substantial dilution if outstanding warrants or pre-funded warrants are exercised for shares common stock78% rewritten
6. 67Ø Raising additional capital or entering into certain licensing arrangements may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates