CytomX Therapeutics (CTMX) risk factors, FY2025 10-K

Risks Related to Our Business

1. 01uncertainties of potential legislation under the new administration, may continue to make it difficult for biotechnology companies to raise additional funds. We cannot predict when or if market conditions will changeNew
2. 02our efforts to enhance operational systems and hire additional personnel, including personnel to support development and commercialization of our product candidates and satisfy our obligations as a public company
3. 03collaborators electing to not pursue development and commercialization of our product candidates78% rewritten
4. 04and ultimately commercialize such product candidates, or experience significant delays in doing so, our business will be materially harmedNew
5. 05varying interpretations of data by the FDA and similar foreign regulatory agencies
6. 06our reputation may suffer
7. 07If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented
8. 08the proximity and availability of clinical trial sites for prospective patients
9. 09We will continue to conduct clinical trials and contract with third-party manufacturers in foreign countries, including Europe and China, which could expose us to risks that could have a material adverse effect on the success of our business54% rewritten
10. 10Because we have no long-term contracts with and rely on third-party manufacturing and supply partners, most of which are sole source suppliers, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality39% rewritten
11. 11applicable regulations and guidelines. The delays associated with the verification of a new manufacturer could negatively affect our ability to develop product candidates in a timely manner or within budget New
12. 12in the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products
13. 13We, or third-party manufacturers, may be unable to successfully scale-up manufacturing of our product candidates in sufficient quality and quantity, which would delay or prevent us from developing our product candidates and commercializing approved products, if any
14. 14Our approach to the discovery and development of our therapeutic treatments is based on novel technologies that are unproven and may not result in marketable products
15. 15Additionally, we entered into a collaboration with Moderna for the development of mRNA based product candidates. We do not know whether our PROBODY platform will be able to successfully develop product candidates utilizing this mRNA technology
16. 16The market may not be receptive to our product candidates based on a novel therapeutic modality, and we may not generate any future revenue from the sale or licensing of product candidates
17. 17If any product candidate we commercialize fails to achieve market acceptance, it could have a material and adverse effect on our business, financial condition, results of operations and prospects
18. 18collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates
19. 19If our collaborators cease development efforts under our collaboration agreements, or if any of those agreements are terminated, these collaborations may fail to lead to commercial products and we may never receive milestone payments or future royalties under these agreements21% rewritten
20. 20If we do not achieve our projected development and commercialization goals in the timeframes we announce, and expect the commercialization of any of our product candidates may be delayed, or never attained, and our business will be harmed
21. 21We may not successfully engage in strategic transactions, including any additional collaborations we seek, which could adversely affect our ability to develop and commercialize product candidates, impact our cash position, increase our expenses and present significant distractions to our management
22. 22If we are unable to successfully develop companion diagnostic tests for certain of our product candidates, or experience significant delays in doing so, we may not realize the full commercial potential of our product candidates
23. 23We may expend our limited resources to pursue a particular product candidate and fail to capitalize on product candidates that may be more profitable or for which there is a greater likelihood of success21% rewritten
24. 24We may experience difficulties in managing our growth and expanding when needed
25. 25Any inability to attract and retain qualified key management and technical personnel would impair our ability to implement our business plan52% rewritten
26. 26for personnel from other companies, universities, public and private research institutions, government entities and other organizations in the biotechnology industry across the country and especially in the San Francisco Bay AreaNew
27. 27Price controls imposed in foreign markets may adversely affect our future profitability
28. 28Our business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could have a material and adverse effect on our business, financial condition, results of operations and prospects
29. 29Our employees and independent contractors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
30. 30Our current operations are concentrated in one location, and we or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
31. 31Our reported financial results may be adversely affected by changes in accounting principles generally accepted in the U.S
32. 32Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited

Risks Related to Intellectual Property

1. 33If we are not able to obtain and enforce patent protection for our technologies or product candidates, development and commercialization of our product candidates may be adversely affected26% rewritten
2. 34We or our licensors, or our collaborators are the first to file patent applications covering certain aspects of our inventions
3. 35The patents of others will not have a material or adverse effect on our business, financial condition, results of operations and prospects
4. 36Other companies or organizations may challenge our or our licensors’ patent rights or may assert patent rights that prevent us from developing and commercializing our products
5. 37We may not be able to protect our intellectual property rights throughout the world89% rewritten
6. 38Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
7. 39If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose our rights to intellectual property rights that are necessary for developing and protecting our product candidates or we could lose certain rights to grant sublicenses
8. 40If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed84% rewritten
9. 41manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants that obligate them to maintain confidentiality and assign their inventions to usNew
10. 42If 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

Risks Related to Government Regulation

1. 43We may be unable to obtain or be delayed in obtaining U.S. or foreign regulatory approval and, as a result, be unable or delayed in being able to commercialize our product candidates
2. 44such authorities may not accept a submission due to, among other reasons, the content or formatting of the submission39% rewritten
3. 45could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our productsNew
4. 46injunctions or the imposition of civil or criminal penalties
5. 47Our product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated21% rewritten
6. 48Healthcare legislative reform measures may have a material and adverse effect on our business and results of operations62% rewritten
7. 49companies, including us, to raise funds from investors for or to obtain collaboration partners who assist us in the funding of research and development of future medicinesNew
8. 50If we or our collaborators, manufacturers or service providers fail to comply with healthcare 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 reputation39% rewritten
9. 51Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition29% rewritten
10. 52Our business may be affected by the evolving regulatory framework for AI TechnologiesNew
11. 53Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business81% rewritten
12. 54the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product candidates obtain regulatory approvalNew
13. 55We may seek and fail to obtain fast track or breakthrough therapy designations for our current or future product candidates. If we are successful, these programs may not lead to a faster development or regulatory review process, and they do not guarantee we will receive approval for any product candidate55% rewritten
14. 56We may seek Orphan Drug Designation for some of our product candidates, and we may be unsuccessful or may be unable to maintain the benefits associated with Orphan Drug Designation, including the potential for market exclusivity23% rewritten

Risks Related to Ownership of Our Common Stock

1. 57Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline
2. 58revenue to be recognized in 2026 and future years may be significantly lower than 2025 as collaboration research terms come to an end
3. 59If we are not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act of 2002 in a timely manner or with adequate compliance, we may be subject to a loss of stockholder confidence and sanctions or investigations by regulatory authorities or litigation
4. 60Our stock price may be volatile and purchasers of our common stock could incur substantial losses
5. 61general economic, industry and market conditions
6. 62The future issuance of equity or of debt securities that are convertible into equity will dilute our share capital29% rewritten
7. 63The employment agreements with our executive officers may require us to pay severance benefits to officers in connection with termination of employment or upon a change of control of us, which could harm our financial condition
8. 64An active market for our common stock may not be maintained
9. 65Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval60% rewritten
10. 66Anti-takeover provisions in our 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
11. 67the authority of the board of directors to issue preferred stock with such terms as the board of directors may determine
12. 68We incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices
13. 69Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain
14. 70Our failure to meet the continued listing requirements of the Nasdaq Global Select Market, including minimum stock price requirements, could result in a delisting of our common stock33% rewritten
15. 71We may incur significant costs from class action litigation due to our expected stock volatility
16. 72Any future pandemic could adversely impact our business, including our research, development, including clinical trials, manufacturing and financial condition
17. 73We cannot be certain of the impact of any future pandemic on our business or make any assurance that research, development or manufacturing of our product candidates will not be delayed, discontinued or otherwise impacted
18. 74Adverse U.S. and multi-national financial market conditions may adversely affect our business and financial position
19. 75We may acquire assets or form strategic alliances in the future, and we may not realize the benefits of such acquisitions
20. 76any unanticipated liabilities for activities of or related to the acquired business or its operations, products or product candidates
21. 77Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties
22. 78Our information technology systems, or those of our CROs or other contractors or consultants we may utilize, may fail, suffer disruptions or suffer security breaches, which could result in a material disruption of our product development programs53% rewritten
23. 79inappropriate disclosure of Confidential Information, we could incur liability, recovery of our data could take a prolonged period of time, and the development of our research or product candidates could be delayedNew
24. 80Ongoing or future international conflicts could adversely affect our business, financial condition, and results of operationsNew
25. 81If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected
26. 82Changes in U.S. or foreign tax laws or regulations that are applied adversely to us may have a material adverse effect on our business, cash flow, financial condition or results of operations
27. 83If securities or industry analysts do not publish research or reports about our business, or if they issue adverse or misleading opinions regarding our stock, our stock price and trading volume could decline