Syndax Pharmaceuticals (SNDX) risk factors, FY2024 10-K

Other

1. 01Summary of Selected Risks
2. 02We are currently developing several product candidates. If we are unable to successfully complete clinical development of, obtain regulatory approval for, and commercialize our product candidates, our business prospects will be significantly harmed
3. 03Revuforj, Niktimvo and our future product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community to be commercially successful
4. 04Our products and product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial scope of their approved use, or result in significant negative consequences following any marketing approval
5. 05While we have product revenue, we may never achieve or maintain profitability
6. 06The market price of our stock may be volatile and you could lose all or part of your investment

Risks Related to Our Business and Industry

1. 07We have limited experience in generating revenue from product sales
2. 08attracting, hiring, and retaining qualified personnel
3. 09Interim top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
4. 10We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of any of our product candidates
5. 11We are subject to numerous risks related to the Incyte Collaboration Agreement to collaborate on the development and commercialization of axatilimab
6. 12We may be required to relinquish important rights to and control over the development and commercialization of our product candidates to our current or future collaborators
7. 13We may explore strategic collaborations that may never materialize or may fail
8. 14Failure to comply with regulatory requirements or unanticipated problems with Revuforj or Niktimvo may result in various adverse actions, such as the suspension or withdrawal of either product, closure of a facility or enforcement of substantial penalties or fines
9. 15closure of the facility, enforcement of substantial fines, injunctions, or the imposition of civil or criminal penalties
10. 16changes in the approval policies or regulations that render our preclinical and clinical data insufficient for approval
11. 17If Revuforj, Niktimvo or future approved product candidates do not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, we may not generate sufficient revenue to become or remain profitable
12. 18The occurrence of any event or penalty described above may inhibit our ability to commercialize and generate revenue from the sale of our product candidates
13. 19our reputation may suffer
14. 20Our failure to obtain regulatory approval in international jurisdictions would prevent us from marketing our product candidates outside the United States
15. 21We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively
16. 22our ability to negotiate preferential formulary status for our product candidates
17. 23We are dependent on UCB Biopharma Sprl, or UCB, to comply with the terms of our license agreement for axatilimab
18. 24Our employees, consultants and collaborators may engage in misconduct or other improper activities, including insider trading and non-compliance with regulatory standards and requirements
19. 25The insurance coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for Revuforj, Niktimvo or any future products could limit our ability to market those products and decrease our ability to generate revenue
20. 26We must attract and retain additional highly skilled employees in order to succeed
21. 27Current and future legislation may increase the difficulty and cost for us to commercialize our product candidates and affect the prices we may obtain
22. 28regulate post-approval activities and affect our ability to profitably sell any product candidate for which we obtain marketing approval
23. 29There have been executive, judicial and Congressional challenges to certain aspects of the Affordable Care Act
24. 30To market Revuforj and Niktimvo or any approved product candidate in the future, we must continue building our sales, marketing, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, as we do not presently have all of these capabilities
25. 31our direct or indirect sales and marketing efforts may not be successful; and
26. 32Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product candidates
27. 33the inability to commercialize any products that we may develop
28. 34Off-label use or misuse of our products may harm our reputation in the marketplace or result in injuries that lead to costly product liability suits
29. 35Our data processing activities subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements, and other obligations relating to data privacy and security
30. 36implement and maintain specific security measures or industry-standard or reasonable security measures to protect our information technology systems and sensitive data
31. 37Social media platforms and AI-based platforms present new risks and challenges to our business

Risks Related to Our Financial Position and Capital Needs

1. 38We have incurred net losses since our inception, except 2021, and anticipate that we will continue to incur net losses for the foreseeable future
2. 39attract, hire and retain additional qualified personnel
3. 40We may require additional capital to finance our planned operations, which may not be available to us on acceptable terms, or at all. As a result, we may not complete the development and commercialization of, or obtain regulatory approval for our existing product candidates or develop new product candidates
4. 41If we need to conduct additional fundraising activities and we do not raise additional capital in sufficient amounts or on terms acceptable to us, we may be unable to pursue development and commercialization efforts, which will harm our business, operating results and prospects
5. 42Changes in tax laws or regulations could materially adversely affect our company
6. 43Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited

Risks Related to Intellectual Property

1. 44If we are unable to obtain or protect intellectual property rights, we may not be able to compete effectively in our market
2. 45We may not be able to protect our intellectual property rights throughout the world
3. 46If we breach the UCB license agreement related to axatilimab or if the UCB license agreement is otherwise terminated, we could lose the ability to continue the development and commercialization of axatilimab
4. 47If we breach the license agreement related to revumenib or if the license agreement is otherwise terminated, we could lose the ability to continue the development and commercialization of revumenib
5. 48Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates
6. 49Obtaining 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
7. 50We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful and have an adverse effect on the success of our business and on our stock price
8. 51or developments. If securities analysts or investors perceive these results to be negative, it could have a downward effect on the price of shares of our common stock
9. 52We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property
10. 53In addition, for some of our in-licensed patents and patent applications, we do not have access to every patent assignment or employee agreement demonstrating that all inventors have assigned their rights to the inventions or related patents. As a result, we may be subject to claims of ownership by such inventors
11. 54Our inability to protect our confidential information and trade secrets would harm our business and competitive position

Risks Related to Ownership of Our Common Stock and Other General Matters

1. 55The market price of our stock may be volatile and you could lose all or part of your investment
2. 56general economic, industry, political and market conditions, including, but not limited to new or ongoing public health crises and the wars between Russia and Ukraine and Hamas and Israel wars as well as the conflicts in the Middle East, including between Israel and Hezbollah
3. 57Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price
4. 58We may sell additional equity or debt securities or enter into other arrangements to fund our operations, which may result in dilution to our stockholders and impose restrictions or limitations on our business
5. 59In addition, we have a significant number of stock options and pre-funded warrants outstanding. To the extent that these have been or may be exercised, stockholders may experience further dilution
6. 60If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline
7. 61Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant influence control over matters subject to stockholder approval
8. 62We may be subject to securities litigation, which is expensive and could divert management attention
9. 63If we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately report our financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our common stock
10. 64Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would benefit our stockholders and may prevent attempts by our stockholders to replace or remove our current management