Theriva Biologics (TOVX) risk factors, FY2024 10-K

RISKS RELATED TO OUR FINANCIAL POSITION AND CAPITAL REQUIREMENTS

1. 01Our auditor’s report on our consolidated financial statements contains an explanatory paragraph regarding our ability to continue as a going concern
2. 02We will need to raise additional capital to operate our business and our failure to obtain funding when needed may force us to delay, reduce or eliminate certain of our development programs or commercialization efforts
3. 03The actual amount of funds we will need to operate is subject to many risk factors, some of which are beyond our control
4. 04We currently have a limited operating history as an oncology company, no products approved for commercial sale, have no significant source of revenue and may never generate significant revenue
5. 05We expect to seek to raise additional capital in the future, which may be dilutive to stockholders or impose operational restrictions
6. 06Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance
7. 07If our acquired intangible assets become impaired in the future as was the case in 2024, we may be required to record a significant charge to earnings

RISKS RELATED TO OUR BUSINESS

1. 08Prior to 2022 we had not conducted any research and development activities directed to cancer diagnosis, treatment or prevention and there can be no assurance that we will successfully be able to do so
2. 09In the past Oncolytic Viruses have experienced certain safety and efficacy challenges
3. 10Our research and development efforts may not result in commercially successful products and technologies, which may limit our ability to achieve profitability
4. 11We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements
5. 12We rely on licenses to use various technologies that are material to our business and we may not be able to retain rights licensed to us by others to commercialize key products and may not be able to establish or maintain the relationships we need to develop, manufacture, and market our products
6. 13We may incur additional expenses in connection with our licenses and collaboration arrangements and our development of our product candidates
7. 14Developments by competitors may render our products or technologies obsolete or non-competitive
8. 15We may seek to selectively establish collaborations, and, if we are unable to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans
9. 16For our Phase 2 clinical trial of VCN-01 in patients with PDAC, we are administering our clinical product candidate, VCN-01, in combination with other approved standard of care drugs. Any problems obtaining the standard of care drugs could result in a delay or interruption in our clinical trials
10. 17If third-party vendors, upon whom we rely to conduct our preclinical studies or clinical trials, do not perform or fail to comply with strict regulations, these studies or trials may be delayed, terminated, or fail, or we could incur significant additional expenses, which could materially harm our business
11. 18We may fail to retain or recruit necessary personnel, and we may be unable to secure the services of consultants
12. 19Global health crises may adversely affect our planned operations
13. 20Business disruptions could seriously harm our future revenue and financial condition and increase costs and expenses
14. 21Unfavorable U.S. or global economic conditions could adversely affect our business, financial condition or results of operations
15. 22We rely extensively on our information technology systems, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks
16. 23Our business and operations would suffer in the event of computer system failures
17. 24We may face particular data protection, data security and privacy risks in connection with the European Union’s Global Data Protection Regulation and other privacy regulations

REGULATORY RISKS

1. 25If we do not obtain the necessary regulatory approvals in the U.S. and/or other countries we will not be able to develop or sell our product candidates
2. 26Clinical trials are very expensive, time-consuming, and difficult to design and implement
3. 27The results of our clinical trials may not support our product candidate claims and the results of preclinical studies and completed clinical trials are not necessarily predictive of future results
4. 28Difficulties enrolling patients in our clinical trials or delays in enrollment are expected to result in our clinical development activities being delayed or otherwise adversely affected
5. 29Patients who are administered our product candidates may experience unexpected side effects or other safety risks that could cause a halt in their clinical development, preclude approval of our product candidates or limit their commercial potential
6. 30It is possible that we may not be able to obtain or maintain orphan drug designation or exclusivity for our drug candidates, which could limit the potential profitability of our product candidates
7. 31Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process, and does not assure FDA approval of our product candidate and, even if we obtain FDA approval, we may not receive marketing approval, marketing exclusivity or other expected benefits
8. 32Our product candidates, if approved for sale, may not gain acceptance among physicians, patients and the medical community, thereby limiting our potential to generate revenues
9. 33We depend on third parties, including researchers and sublicensees, who are not under our control. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to seek or obtain regulatory approval for or commercialize our product candidates
10. 34These collaborators may also have relationships with other commercial entities, some of which may compete with us. Our collaborators assisting our competitors could harm our competitive position
11. 35Reimbursement may not be available for our product candidates, which would impede sales
12. 36Healthcare reform measures could hinder or prevent our product candidates’ commercial success
13. 37If we fail to comply with state and federal healthcare regulatory laws, we could face substantial penalties, damages, fines, disgorgement, exclusion from participation in governmental healthcare programs, and the curtailment of operations, any of which could harm our business
14. 38If we obtain approval to commercialize our clinical product candidates outside of the United States, a variety of risks associated with international operations could harm our business
15. 39If product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
16. 40We rely on patents, patent applications, trade secrets and various regulatory exclusivities to protect some of our product candidates and our ability to compete may be limited or eliminated if we are not able to protect our products
17. 41We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, as well as costs associated with lawsuits
18. 42We cannot guarantee that the practice of our technologies will not conflict with the rights of others. In some foreign jurisdictions, we could become involved in opposition proceedings, either by opposing the validity of another’s foreign patent or by persons opposing the validity of our foreign patents
19. 43If we infringe the rights of others, we could be prevented from selling products or forced to pay damages
20. 44We enjoy restricted geographical protection with respect to certain patents
21. 45We may become subject to claims challenging inventorship or ownership of our patents and other intellectual property

RISKS RELATING TO OUR SECURITIES

1. 46We cannot assure you that our common stock will be liquid or that it will remain listed on the NYSE American
2. 47The market price of our common stock has been and may continue to be volatile and adversely affected by various factors
3. 48Our articles of incorporation and bylaws and Nevada law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline
4. 49We do not intend to pay dividends in the foreseeable future on our common stock
5. 50Resales of our common stock in the public market by our stockholders may cause the market price of our common stock to fall
6. 51The shares of common stock offered under our current Amended and Restated At The Market Issuance Sales Agreement may be sold in “at the market” offerings, and investors who buy shares at different times will likely pay different prices