Phio Pharmaceuticals (PHIO) risk factors, FY2024 10-K

Risks Relating to Our Business and Industry

1. 01We are dependent on the success of our INTASYL technology, and our product candidates based on this platform, which is unproven and may never lead to approved and marketable products
2. 02Our product candidates are in an early stage of development and we may fail, experience significant delays, never advance clinical development or not be successful in our efforts to identify or discover additional product candidates, which may materially and adversely impact our business
3. 03If we experience delays or difficulties in identifying and enrolling patients in clinical trials, it may lead to delays in generating clinical data and the receipt of necessary regulatory approvals
4. 04Topline data may not accurately reflect or may materially differ from the complete results of a clinical trial
5. 05We rely upon third-parties to conduct our clinical trials and other studies for our product candidates, and if they do not successfully fulfill their obligations, the development of our product candidates may be materially impacted
6. 06Changes in U.S. and international trade policies may adversely impact our business and operating results
7. 07A number of different factors could prevent us from advancing into clinical development, obtaining regulatory approval, and ultimately commercializing our product candidates on a timely basis, or at all
8. 08Disruptions at the FDA, including due to a reduction in the FDA’s workforce and/or inadequate funding for the FDA, could prevent the FDA from performing normal functions on which our business relies, which could negatively impact our business
9. 09We are subject to significant competition and may not be able to compete successfully
10. 10If we fail to attract, hire and retain qualified personnel, we may not be able to design, develop, market or sell our products or successfully manage our business
11. 11We are subject to potential liabilities from clinical testing and future product liability claims
12. 12We rely upon third parties for the manufacture of the clinical supply for our product candidates
13. 13Unstable market and economic conditions, including elevated and sustained inflation, may have serious adverse consequences on our business, financial condition and stock price
14. 14Our business and operations would suffer in the event of computer system failures, cyberattacks or a deficiency in our cybersecurity

Risks Relating to Our Intellectual Property

1. 15We may be involved in litigation to protect our patents and intellectual property rights and our ability to protect our patents and intellectual property rights is uncertain and may subject us to potential liabilities
2. 16Third-parties may claim that we infringe their patents, which may result in substantial liabilities and prevent us from pursuing the development of our product candidates
3. 17We are dependent on the patents we own and the technologies we license, and if we fail to maintain our patents or lose the right to license such technologies, our ability to develop new products would be harmed

Risks Relating to Our Financial Condition

1. 18We will require substantial additional funds to complete our research and development activities
2. 19We have a history of net losses, and we expect to continue to incur net losses for the foreseeable future and may not achieve or maintain profitability
3. 20Future financing may be obtained through, and future development efforts may be paid for by, the issuance of debt or equity, which may have an adverse effect on our stockholders or may otherwise adversely affect our business
4. 21We expect to continue to incur significant research and development expenses, which may make it difficult for us to attain profitability, and may lead to uncertainty as to our ability to continue as a going concern
5. 22Our ability to utilize net operating loss carryforwards and other tax benefits may be limited

Risks Relating to Our Securities

1. 23The price of our Common Stock has been and may continue to be volatile
2. 24We may not be able to maintain compliance with the continued listing requirements of The Nasdaq Capital Market
3. 25Our Board of Directors has the authority to issue shares of “blank check” preferred stock and the terms of the preferred stock may reduce the value of our Common Stock
4. 26We may acquire other businesses or form joint ventures that may be unsuccessful and could dilute your ownership interest in the Company
5. 27Provisions of our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change of control of the Company or changes in our management and, as a result, depress the trading price of our Common Stock