Soligenix (SNGX) risk factors, FY2024 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 efforts
2. 02of March 14, 2025 we had approximately $7.7 million in cash and cash equivalents available. Without additional funding, based on our projected budgetary needs and funding from existing contracts and grants over the next year, we expect to be able to maintain the current level of our operations to the end of 2025
3. 03Our losses from operations, negative cash flows, and shareholders' deficit as of December 31, 2024 raise substantial doubt about our ability to continue as a going concern absent obtaining adequate new debt or equity financings
4. 04The report of our independent registered accounting firm on our audited financial statements for the fiscal year ended December 31, 2024 contains an explanatory paragraph relating to our ability to continue as a going concern
5. 05If we are unable to develop our product candidates, our ability to generate revenues and viability as a company will be significantly impaired
6. 06We 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
7. 07We 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
8. 08Our business is subject to extensive governmental regulation, which can be costly, time consuming and subjects us to unanticipated delays
9. 09There may be unforeseen challenges in developing our biodefense products
10. 10We are dependent on government funding, which is inherently uncertain, for the success of our biodefense operations
11. 11The 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
12. 12We 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
13. 13Even if approved, our products will be subject to extensive post-approval regulation
14. 14Even if we obtain regulatory approval to market our product candidates, our product candidates may not be accepted by the market
15. 15community may not accept and utilize any of our product candidates. If our products do not achieve market acceptance, we will not be able to generate significant revenues or become profitable
16. 16We do not have extensive sales and marketing experience and our lack of experience may restrict our success in commercializing some of our product candidates
17. 17Our products, if approved, may not be commercially viable due to change in health care practice and third party reimbursement limitations
18. 18Our 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
19. 19If 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
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 industry
27. 27Competition and technological change may make our product candidates and technologies less attractive or obsolete
28. 28Our business could be harmed if we fail to retain our current personnel or if they are unable to effectively run our business
29. 29Instability and volatility in the financial markets could have a negative impact on our business, financial condition, results of operations, and cash flows
30. 30Changes in U.S. and international trade policies may adversely impact our business and operating results
31. 31Adverse developments affecting financial institutions such as actual events or concerns involving liquidity, defaults or non-performance, could adversely affect our operations and liquidity
32. 32We may not be able to utilize all of our net operating loss carryforwards
33. 33Global pathogens that could have an impact on financial markets, materials sourcing, patients, governments and population (e.g. COVID-19)

Risks Related to our Intellectual Property

1. 34We 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. 35We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming
3. 36If 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. 37Our strategy includes an increasing dependence on technology in our operations. If any of our key technology fails, our business could be adversely affected
2. 38A 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. 39The price of our common stock may be highly volatile
2. 40If 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 capital
3. 41Shareholders may suffer substantial dilution related to issued common stock warrants, and options
4. 42Our 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. 43We 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. 44Upon our dissolution, our stockholders may not recoup all or any portion of their investment
7. 45The 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. 46The 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. 47Our Board of Directors can, without stockholder approval, cause preferred stock to be issued on terms that adversely affect holders of our common stock