TAO Synergies (TAOX) risk factors, FY2024 10-K

Risks Related to Our Evaluation of Strategic Alternatives

1. 01Our exploration and pursuit of strategic alternatives may not be successful

Risks Related to Our Business and Financial Condition

1. 02If we continue to execute our current development strategy, we will need additional financing to fund our operations in the future. If we are unable to obtain additional financing on acceptable terms, we will need to curtail or cease our development plans and operations
2. 03Our ongoing viability as a company depends on our ability to successfully develop and commercialize our licensed technology
3. 04If the CRE License were terminated, we may be required to cease operations
4. 05We rely on independent third-party contract research organizations to perform clinical and non-clinical studies of our drug candidate and to perform other research and development services
5. 06We have relied on the representations and materials provided by CRE, including scientific, peer-reviewed and non-peer reviewed publications, abstracts, slides, internal documents, verbal communications, patents and related patent filings, with respect to the results of its research related to our proposed products
6. 07We have a limited operating history upon which investors can evaluate our future prospects
7. 08If we do not obtain the necessary regulatory approvals in the United States and/or other countries, we will not be able to sell our drug candidates
8. 09The commencement and completion of clinical trials can be delayed or prevented for a number of reasons
9. 10Even if regulatory approvals are obtained for our product candidates, we will be subject to ongoing government regulation. If we fail to comply with applicable current and future laws and government regulations, it could delay or prevent the promotion, marketing or sale of our products
10. 11Data from our Bryostatin-1 Phase 2 clinical trial, from our confirmatory Phase 2 clinical trial and our expanded Phase 2 clinical trial may be subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share the Company’s views of the data
11. 12We have not generated any revenues since our inception and we do not expect to generate revenue for the foreseeable future. If we do not generate revenues and achieve and sustain profitability, we will likely need to curtail or cease our development plans and operations
12. 13Our commercial success will depend, in part, on our ability, and the ability of our licensors, to obtain and maintain patent protection. Our licensors’ failure to obtain and maintain patent protection for our products may have a material adverse effect on our business
13. 14Our licensed patented technologies may infringe on other patents, which may expose us to costly litigation
14. 15We may not be able to protect our trade secrets and other unpatented proprietary technologies, which could give our competitors an advantage over us
15. 16If we are unable to hire additional qualified personnel, our business prospects may suffer
16. 17We may not be able to in-license or acquire new development-stage products or technologies
17. 18We are partly dependent upon the NCI to supply bryostatin for our clinical trials
18. 19We expect to rely on third parties to manufacture our proposed products and, as a result, we may not be able to control our product development or commercialization
19. 20We may rely on third parties for marketing and sales and our revenue prospects may depend on their efforts
20. 21If our products are not accepted by patients, the medical community or health insurance companies, our business prospects will suffer
21. 22The branded prescription segment of the pharmaceutical industry in which we operate is competitive, and we are particularly subject to the risks of such competition
22. 23Our business will expose us to potential product liability risks, which could result in significant product liability exposure
23. 24A successful clinical trial liability claim against us could have a material adverse effect on our financial condition even with such insurance coverage
24. 25A successful liability claim against us could have a material adverse effect on our financial condition
25. 26Reforms in the healthcare industry and the uncertainty associated with pharmaceutical and laboratory test pricing, reimbursement and related matters could adversely affect the marketing, pricing and demand for our products
26. 27Disruptions in federal government operations or extended government shutdowns may negatively impact our business
27. 28Our business and operations would suffer in the event of computer system failures
28. 29Consolidation in the pharmaceutical industry could materially affect our ability to operate as an independent entity
29. 30assessing their potential impacts on our business. In addition, sanctions on Russia and hostilities involving Israel could adversely affect the global economy and financial markets and lead to instability and lack of liquidity in capital markets, potentially making it more difficult for us to obtain additional funds
30. 31Failure to maintain effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act could materially and adversely affect us
31. 32We may be unable to adequately protect our information systems from cyberattacks, which could result in the disclosure of confidential or proprietary information, including personal data, damage our reputation, and subject us to significant financial and legal exposure
32. 33Our failure to comply with data protection laws and regulations could lead to government enforcement actions, private litigation and/or adverse publicity and could negatively affect our operating results and business
33. 34Our employees, independent contractors, principal investigators, contract research organizations, consultants or vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements

Risks Relating to our Common Stock and the Securities Market

1. 35The market price of our common stock has been volatile
2. 36If we fail to meet the continued listing standards of Nasdaq, our common stock may be delisted, which may adversely affect the market price and liquidity of our common stock
3. 37As of December 31, 2024, we had an aggregate of 1,357,165 shares of Common Stock outstanding. Except for 7,681 shares, all of those shares are freely tradable without restriction or registration under the Securities Act of 1933, as amended (the “Securities Act”)
4. 38If securities or industry analysts do not publish research or publish misleading or unfavorable research about our business, our stock price and trading volume could decline
5. 39We do not expect to pay any cash dividends for the foreseeable future
6. 40Provisions in our certificate of incorporation, our bylaws or Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our Common Stock
7. 41You may experience dilution of your ownership interests because of the future issuance of additional shares of our Common Stock
8. 42We may obtain additional capital through the issuance of preferred stock, which may limit your rights as a holder of our Common Stock
9. 43We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our Common Stock less attractive to investors