Soligenix (SNGX)

Risks

• Risks Related to our Business
• Risks Related to our Intellectual Property
• Risks Related to our Securities
• We 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.
• If we are unable to develop our product candidates, our ability to generate revenues and viability as a company will be significantly impaired.
• We 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.
• We 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.
• Our business is subject to extensive governmental regulation, which can be costly, time consuming and subjects us to unanticipated delays.
• There may be unforeseen challenges in developing our biodefense products.
• We are dependent on government funding, which is inherently uncertain, for the success of our biodefense operations.
• The terms of our loan and security agreement with Pontifax Medison Finance require, and any future debt financing may require, us to meet certain operating covenants and place restrictions on our operating and financial flexibility.
• If the parties we depend on for supplying our drug substance raw materials and certain manufacturing-related services do not timely supply these products and services, it may delay or impair our ability to develop, manufacture and market our products. We do not have or anticipate having internal manufacturing capabilities.
• We rely on third parties for pre-clinical and clinical trials of our product candidates and, in some cases, to maintain regulatory files for our product candidates. If we are not able to maintain or secure agreements with such third parties on acceptable terms, if these third parties do not perform their services as required, or if these third parties fail to timely transfer any regulatory information held by them to us, we may not be able to obtain regulatory approval for, or commercialize, our product candidates.
• The 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.
• We 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.
• Even if approved, our products will be subject to extensive post-approval regulation.
• Even if we obtain regulatory approval to market our product candidates, our product candidates may not be accepted by the market.
• We do not have extensive sales and marketing experience and our lack of experience may restrict our success in commercializing some of our product candidates.
• Our products, if approved, may not be commercially viable due to change in health care practice and third party reimbursement limitations.
• Our 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.
• If 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.
• Federal and/or state health care reform initiatives could negatively affect our business.
• We 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.
• We may suffer product and other liability claims; we maintain only limited product liability insurance, which may not be sufficient.
• We 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.
• We may not be able to compete with our larger and better financed competitors in the biotechnology industry.
• Competition and technological change may make our product candidates and technologies less attractive or obsolete.
• Our business could be harmed if we fail to retain our current personnel or if they are unable to effectively run our business.
• Instability and volatility in the financial markets could have a negative impact on our business, financial condition, results of operations, and cash flows.
• We may not be able to utilize all of our net operating loss carryforwards.
• Global pathogens that could have an impact on financial markets, materials sourcing, patients, governments and population (e.g. COVID-19).
• We 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.
• We may be involved in lawsuits to protect or enforce our patents, which could be expensive and time consuming.
• If we infringe the rights of third parties we could be prevented from selling products, forced to pay damages, and defend against litigation.
• The price of our common stock may be highly volatile.
• If we fail to remain current with our 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.
• The warrants may not have any value.
• Shareholders may suffer substantial dilution related to issued stock warrants, options and convertible notes.
• Our shares of common stock and warrants are thinly traded, so stockholders may be unable to sell at or near ask prices or at all if they need to sell shares or warrants to raise money or otherwise desire to liquidate their shares.
• We 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.
• Upon our dissolution, our stockholders may not recoup all or any portion of their investment.
• The 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.
• Repayment of certain convertible notes, if they are not otherwise converted, will require a significant amount of cash, and we may not have sufficient cash flow from our business to make payments on our indebtedness.
• The issuance of shares of common stock upon conversion of the Convertible Notes could substantially dilute shareholders’ investments and could impede our ability to obtain additional financing.