Context Therapeutics (CNTX) risk factors, FY2025 10-K

Risks Related to Our Business and Industry

1. 01We have never been profitable and may never achieve or maintain profitability
2. 02We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations
3. 03If we are unable to raise substantial additional capital on acceptable terms, or at all, we may be forced to delay, reduce or eliminate some or all of our research programs, product development activities and commercialization efforts
4. 04If we are not able to successfully integrate recent and future acquisitions, our management’s attention could be diverted, and efforts to integrate future acquisitions could consume significant resources
5. 05We are a biopharmaceutical company with a limited operating history. We were founded in 2015 and spent the first three years of our company’s history developing and refining our therapeutic approach, and only since then have we focused our efforts on advancing the development of product candidates20% rewritten
6. 06We may expend our limited resources pursuing particular research programs or product candidates that may be less successful or profitable than other programs or product candidates
7. 07Fluctuating foreign exchange rates could increase our operating expenses and adversely affect our results of operations
8. 08Inflation, geopolitical developments, global supply chain disruptions and public health concerns could adversely affect our business and results of operationsNew
9. 09Changes in U.S. trade policy, including the imposition of tariffs and the resulting consequences, may have a material adverse impact on our business, financial condition, and results of operationsNew

Risks Related to our Product Candidates

1. 10Our business is dependent on the successful development, regulatory approval and commercialization of our therapeutic product candidates, CTIM-76, CT-95 and CT-202, which are in the early stages of development
2. 11We have no products approved for sale. The success of our business, including our ability to finance our Company and generate any revenue in the future, will primarily depend on the successful development, regulatory approval and commercialization of CTIM-76, CT-95 and CT-202, which may never occur66% rewritten
3. 12our current and any future product candidates, and we may be required to expend significant resources to obtain regulatory approval and to comply with ongoing regulations in these jurisdictionsNew
4. 13Results of preclinical studies, early clinical trials or analyses may not be indicative of results obtained in later trials
5. 14Interim “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data82% rewritten
6. 15We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties or delays enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
7. 16The success of our business depends primarily upon our ability to identify, develop and commercialize products using our proprietary technologies23% rewritten
8. 17Our innovative therapy approach is based on novel ideas and technologies that are unproven and may not result in marketable products, which exposes us to unforeseen risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory approval
9. 18If a product candidate does not achieve projected development milestones or commercialization in the announced or expected timeframes, the further development or commercialization of such product candidate may be delayed, and our business will be harmed
10. 19We face an inherent risk of product liability and professional indemnity exposure related to the testing in clinical trials of our product candidates. We will face an even greater liability risk if we commercially sell any products that we or our collaborators may develop for human use
11. 20Product liability insurance coverage may not be adequate to cover all liabilities that we may incur. We anticipate that we will need to increase our insurance coverage when we expand our clinical trials and if we or our collaborators successfully commercialize any productsNew
12. 21Fast track designation from the FDA may not actually lead to a faster development or regulatory review or approval processNew
13. 22We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidatesNew

Risks Related to Our Organization, Structure and Operations

1. 23Our reliance on a central team consisting of a limited number of employees and consultants who provide various administrative, research and development, and other services across our organization presents operational challenges that may adversely affect our business
2. 24Our future success depends on our ability to retain our Chief Executive Officer, Chief Medical Officer, Chief Financial Officer, Chief Legal Officer, and other key executives and to attract, retain and motivate qualified personnel23% rewritten
3. 25Although we have formal employment agreements with all of our executive officers, these agreements do not prevent them from terminating their employment with us at any time. The loss of the services of any of these persons could impede the achievement of our research, development and commercialization objectives
4. 26We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations
5. 27Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities
6. 28Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions, could adversely affect our current and projected business operations, financial condition and results of operations67% rewritten

Risks Related to Our Reliance on Third Parties

1. 29We expect to, and do, depend on collaborations with third parties for certain research, development and commercialization activities, and if any such collaborations are not successful, it may harm our business and prospects21% rewritten
2. 30could result in the loss of opportunity to work with that collaborator or reputational damage that could impact our relationships with other collaborators in the relatively small industry communities in which we operateNew
3. 31We may become involved in disagreements or disputes with our licensees, licensors and other counterparties relating to the development and/or commercialization of our current or past product candidates, which may be time consuming, costly and could harm our efforts to develop our current or future product candidates
4. 32If we are unable to obtain sufficient quantities of raw materials and supplies, at acceptable prices and on a timely basis, it could harm our business
5. 33We do, and may further, rely on third parties for the manufacturing process of our current and any future product candidates, and failure by those parties to adequately perform their obligations could harm our business34% rewritten
6. 34If we are not able to establish collaborations on commercially reasonable terms, we may have to alter our research, development and commercialization plans

Risks Related to Government Regulation

1. 35The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our current and any future product candidates
2. 36We expect that CTIM-76, CT-95 and CT-202 will be regulated as biological products, or biologics, and therefore they may be subject to competition from biosimilar applicants52% rewritten
3. 37The FDA may disagree with our regulatory plan and we may fail to obtain regulatory approval of any product candidate
4. 38Obtaining and maintaining regulatory approval of a product candidate in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of such product candidate in other jurisdictions
5. 39Even if we obtain regulatory approval of a product candidate, the product may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community
6. 40Coverage and reimbursement may be limited or unavailable in certain market segments for a product candidate, which could make it difficult for us to sell such product candidate, if approved, profitably
7. 41Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. Obtaining coverage and adequate reimbursement from third-party payors is critical to new product acceptance
8. 42We 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 requirements or experience unanticipated problems with a product candidate
9. 43The advancement of healthcare reform may negatively impact our ability to sell our current and any future product candidates, if approved, profitably
10. 44In addition, other legislative changes have been proposed and adopted in the United States since PPACA was enacted which, among other things, have reduced Medicare payments to several types of providers, including hospitals and cancer treatment centers
11. 45Changes to United States federal regulatory agencies may cause disruptions and delays in government approval processes and regulations relating to our product candidatesNew

Risks Related to Intellectual Property

1. 46Patents and patent applications involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our business position
2. 47As a result of any patent infringement claims, or in order to avoid any potential infringement claims, we may choose to seek, or be required to seek, a license from a third party, which may require payment of substantial royalties or fees, or require us to grant a cross-license under our intellectual property rights
3. 48Our ability to compete effectively in our markets may decline if we do not adequately protect our proprietary rights, and our proprietary rights do not necessarily address all potential threats to our competitive advantages
4. 49In the United States, the natural expiration of a patent is generally 20 years after it is filed. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited
5. 50If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business
6. 51We may not be able to protect our intellectual property rights throughout the world46% rewritten
7. 52Changes in U.S. patent law, and the laws of other countries, could diminish the value of patents in general, thereby impairing our ability to protect our products

Risks Related to the Market for Our Common Stock

1. 53Our common stock may be volatile or may decline regardless of our operating performance21% rewritten
2. 54We may not be able to maintain compliance with the continued listing requirements of The Nasdaq Stock Market47% rewritten
3. 55Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates80% rewritten
4. 56FINRA sales practice requirements may limit a stockholder’s ability to buy and sell our common stock
5. 57We are subject to ongoing public reporting requirements that are less rigorous than Exchange Act rules for companies that are not emerging growth companies and our stockholders could receive less information than they might expect to receive from more mature public companies
6. 58If we fail to maintain effective internal control over financial reporting and effective disclosure controls and procedures, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which may adversely affect investor confidence in our company
7. 59We incur increased costs as a result of being a public company and in the administration of our organizational structure
8. 60We are subject to complex tax rules relating to our business, and any audits, investigations or tax proceedings could have a material adverse effect on our business, results of operations and financial condition
9. 61Our business and operations would suffer in the event of system failures or security breaches
10. 62We or third parties with whom we have relationships may be adversely affected by natural or manmade disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
11. 63We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
12. 64We could be subject to securities class action litigation or litigation challenging the validity of provisions in our amended and restated certificate of incorporation or amended and restated bylawsNew