Soligenix (SNGX) risk factors, FY2025 10-K

Risks Related to our Business

1. 01We have had significant losses and anticipate future losses; if additional funding cannot be obtained, we may reduce or discontinue our product development and commercialization efforts95% rewritten
2. 02Our losses from operations, negative cash flows, and shareholders' deficit as of December 31, 2025 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings38% rewritten
3. 03The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2025 contains an explanatory paragraph relating to our ability to continue as a going concern
4. 04If we are unable to develop our product candidates, our ability to generate revenues and viability as a company will be significantly impaired
5. 05We expect a number of factors to cause our operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict our future performance
6. 06We have no approved products on the market and therefore do not expect to generate any revenues from product sales in the foreseeable future, if at all
7. 07Our business is subject to extensive governmental regulation, which can be costly, time consuming and subjects us to unanticipated delays
8. 08There may be unforeseen challenges in developing our biodefense products
9. 09We are dependent on government funding, which is inherently uncertain, for the success of our biodefense operations
10. 10The manufacturing of our products is a highly exacting process, and if we or one of our materials suppliers encounter problems manufacturing our products, our business could suffer
11. 11We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success
12. 12Even if approved, our products will be subject to extensive post-approval regulation
13. 13Even if we obtain regulatory approval to market our product candidates, our product candidates may not be accepted by the market21% rewritten
14. 14We do not have extensive sales and marketing experience and our lack of experience may restrict our success in commercializing some of our product candidates
15. 15Our products, if approved, may not be commercially viable due to change in health care practice and third-party reimbursement limitations
16. 16Our product candidates may cause serious adverse events or undesirable side effects which may delay or prevent marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales
17. 17If we fail to obtain or maintain orphan drug exclusivity for our product candidates, our competitors may sell products to treat the same conditions and our revenue will be reduced
18. 18Our business strategy includes the potential receipt and monetization of PRVs, but there can be no assurance that we will qualify for, receive or realize value from any such voucher, and changes in the PRV programs or our development plans could materially and adversely affect this aspect of our businessNew
19. 19expectations. In addition, PRV transactions are typically complex, privately negotiated arrangements that may require us to make representations, warranties, indemnities or other commitments that could expose us to post closing liabilitiesNew
20. 20Federal and/or state health care reform initiatives could negatively affect our business
21. 21We may not be able to retain rights licensed to us by third parties to commercialize key products or to develop the third-party relationships we need to develop, manufacture and market our products
22. 22Additionally, the milestone and other payments associated with these licenses will make it less profitable for us to develop our drug candidates. See “Business – Patents and Other Proprietary Rights” for a description of our license agreements
23. 23If disputes over intellectual property and other rights that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates
24. 24We may suffer product and other liability claims; we maintain only limited product liability insurance, which may not be sufficient
25. 25We may use hazardous chemicals in our business. Potential claims relating to improper handling, storage or disposal of these chemicals could affect us and be time consuming and costly
26. 26We may not be able to compete with our larger and better financed competitors in the biotechnology industry53% rewritten
27. 27superior to our technologies and products. We may not be able to compete with our existing and future competitors, which could lead to the failure of our businessNew
28. 28Competition and technological change may make our product candidates and technologies less attractive or obsolete
29. 29Our business could be harmed if we fail to retain our current personnel or if they are unable to effectively run our business
30. 30Instability and volatility in the financial markets could have a negative impact on our business, financial condition, results of operations, and cash flows
31. 31Changes in U.S. and international trade policies may adversely impact our business and operating results91% rewritten
32. 32Adverse developments affecting financial institutions such as actual events or concerns involving liquidity, defaults or non-performance, could adversely affect our operations and liquidity
33. 33We may not be able to utilize all of our net operating loss carryforwards37% rewritten
34. 34Global pathogens that could have an impact on financial markets, materials sourcing, patients, governments and population (e.g. COVID-19)
35. 35Escalation of armed conflict and geopolitical instability in the Middle East, including tensions involving Israel, Iran and the United States, could materially disrupt our clinical development activities in general and specifically those relating to SGX945 (dusquetide) for the treatment of BDNew

Risks Related to our Intellectual Property

1. 36We may be unable to commercialize our products if we are unable to protect our proprietary rights, and we may be liable for significant costs and damages if we face a claim of intellectual property infringement by a third party
2. 37We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming
3. 38If we infringe the rights of third parties we could be prevented from selling products, forced to pay damages, and defend against litigation

Risks Related to Technology and Intellectual Property

1. 39Our strategy includes an increasing dependence on technology in our operations. If any of our key technology fails, our business could be adversely affected29% rewritten
2. 40We may utilize generative artificial intelligence (“AI”) tools in certain aspects of our operations, including drafting, analysis, administrative functions and other business processes. While these technologies may enhance efficiency, their use involves risks that could adversely affect our businessNew
3. 41The legal and regulatory landscape surrounding artificial intelligence technologies is evolving. Future laws, regulations or regulatory interpretations could impose additional requirements or restrictions on the use of AI tools, increase compliance costs or limit our ability to utilize such technologies effectivelyNew
4. 42A cybersecurity incident could negatively impact our business and our relationships with our employees, service providers, patients, clinical study sites and government agencies

Risks Related to our Securities

1. 43The price of our common stock may be highly volatile20% rewritten
2. 44If we fail to meet Nasdaq’s listing requirements, we could be removed from The Nasdaq Capital Market, which would limit the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market and negatively impact our ability to raise capital40% rewritten
3. 45Shareholders may suffer substantial dilution related to issued common stock warrants, and options43% rewritten
4. 46Our shares of common stock are thinly traded, so stockholders may be unable to sell at or near ask prices or at all if they need to sell shares to raise money or otherwise desire to liquidate their shares
5. 47We do not currently intend to pay dividends on our common stock in the foreseeable future, and consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our common stock
6. 48Upon our dissolution, our stockholders may not recoup all or any portion of their investment
7. 49The issuance of our common stock pursuant to the terms of the asset purchase agreement with Hy Biopharma Inc. may cause dilution and the issuance of such shares of common stock, or the perception that such issuances may occur, could cause the price of our common stock to fall
8. 50The number of shares that we may issue under the Asset Purchase Agreement will fluctuate based on the market price of our common stock. Depending on market liquidity at the time, the issuance of such shares may cause the trading price of our common stock to fall
9. 51Our Board of Directors can, without stockholder approval, cause preferred stock to be issued on terms that adversely affect holders of our common stock