Verastem (VSTM) risk factors, FY2024 10-K

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

1. 01Even if avutometinib and defactinib, or any of our other product candidates, receives marketing approval, such product candidates may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success
2. 02A 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
3. 03If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented
4. 04Research 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 and avutometinib are effective in improving outcomes for patients with cancer
5. 05The market opportunities for our 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
6. 06We face substantial competition, which may result in others developing or commercializing products before or more successfully than we do
7. 07If we fail to obtain regulatory approval in jurisdictions outside the United States, we will not be able to market our products in those jurisdictions
8. 08If 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 candidates
9. 09Avutometinib and defactinib are being administered and studied in our Phase 1, Phase 2, and Phase 3 clinical trials, and the development program continues to progress. For both avutometinib and defactinib, the toxicities reported to date have been predictable and appear to be manageable
10. 10We 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
11. 11Any 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
12. 12We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercially sell any other products we may develop
13. 13A 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. 14Our 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. 15If 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. 16We 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. 17We have incurred significant losses since our inception. We may incur losses for the foreseeable future and may never achieve or maintain profitability
2. 18We 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 and defactinib
3. 19We will require additional financing to execute our operating plan and continue to operate as a going concern
4. 20Unfavorable economic conditions could have a material adverse effect on our business, financial condition, results of operations, or cash flows
5. 21Our ability to use our net operating loss carryforwards may be limited

Risks Related to Our Indebtedness

1. 22Our 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. 23We 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. 24We 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. 25Any 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. 26We 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. 27We contract with third parties for the manufacture of our product candidates and for compound formulation research, and these third parties may not perform satisfactorily
5. 28If we are not able to establish additional collaborations, we may have to alter our development and commercialization plans
6. 29We 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. 30Our 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. 31If 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. 32If 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 market
3. 33We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses
4. 34Obtaining 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
5. 35Issued patents covering our products could be found invalid or unenforceable if challenged in court or the USPTO
6. 36Changes to patent law in the United States and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products
7. 37We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world
8. 38If we do not obtain patent term extension and data exclusivity for any of our current products, our business may be materially harmed
9. 39Competitors 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
10. 40Third 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
11. 41We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
12. 42We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
13. 43Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
14. 44If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
15. 45If 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
16. 46European 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. 47If 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 impaired
2. 48We 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 candidates
3. 49Any product candidate for which we obtain marketing approval could be subject to restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, when and if any of them are approved
4. 50Current 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 obtain
5. 51Disruptions 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
6. 52Due to the recent change in presidential administration, we face uncertainty regarding potential regulatory developments that may adversely affect our business

Risks Related to Employee Matters and Managing Growth

1. 53Our 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. 54We 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. 55Our business and operations may be materially adversely affected in the event of computer system breaches or failures

Risks Related to Our Capital Stock

1. 56Provisions 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. 57The market price of our common stock has been, and may continue to be, highly volatile
3. 58Because 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. 59We can issue and have issued shares of preferred stock, which may adversely affect the rights of holders of our common stock
5. 60Our stockholders will experience substantial dilution if outstanding warrants or pre-funded warrants are exercised for shares common stock
6. 61Raising 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