Theriva Biologics (TOVX) risk factors, FY2025 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 concern41% rewritten
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 34% rewritten
3. 03The actual amount of funds we will need to operate is subject to many 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 revenue28% rewritten
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
8. 08A prolonged U.S. federal government shutdown could materially and adversely affect our business and operationsNew
9. 09Federal budget and debt-ceiling disputes may adversely affect capital markets and our financing activitiesNew

RISKS RELATED TO OUR BUSINESS

1. 10Prior 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. 11In the past OVs have experienced certain safety and efficacy challenges
3. 12Our research and development efforts may not result in commercially successful products and technologies, which may limit our ability to achieve profitability29% rewritten
4. 13We have in the past, and may continue to seek to, 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 arrangements32% rewritten
5. 14We rely on licenses to use various technologies that are material to our business and w e 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. 15We may incur additional expenses in connection with our licenses and collaboration arrangements and our development of our product candidates
7. 16Developments by competitors may render our products or technologies obsolete or non-competitive
8. 17We 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. 18For our clinical trials of VCN-01 (zabilugene almadenorepvec), we have or will administer our product candidate, VCN-01, in combination with other cancer drugs. Any problems obtaining these co-administered drugs could result in a delay or interruption in our clinical trialsNew
10. 19If 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. 20We may fail to retain or recruit necessary personnel, and we may be unable to secure the services of consultants59% rewritten
12. 21Global health crises may adversely affect our planned operations
13. 22Business disruptions could seriously harm our future revenue and financial condition and increase costs and expenses
14. 23Unfavorable U.S. or global economic conditions could adversely affect our business, financial condition or results of operations53% rewritten
15. 24Changes to trade policy, including tariff and customs regulations, or failure to comply with such regulations may have an adverse effect on our reputation, business, financial condition and results of operationsNew
16. 25We rely extensively on our information technology systems, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks
17. 26Our business and operations would suffer in the event of computer system failures
18. 27We 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. 28If 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. 29Clinical trials are very expensive, time-consuming, and difficult to design and implement
3. 30The 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. 31Difficulties 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. 32Patients 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. 33It 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. 34Fast 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 benefits22% rewritten
8. 35Our 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. 36We 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. 37These 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. 38Reimbursement may not be available for our product candidates, which would impede sales73% rewritten
12. 39or that subjects the price of our products to governmental control, we may not be able to generate revenue, attain profitability or commercialize our productsNew
13. 40Healthcare reform measures could hinder or prevent our product candidates’ commercial success80% rewritten
14. 41If 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
15. 42If 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
16. 43If product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates
17. 44We and our subsidiaries are subject to U.S. and foreign tax laws, and changes to such tax laws or differing interpretation of those laws by the relevant governmental authorities could adversely affect our business and operating resultsNew
18. 45We 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
19. 46We 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 lawsuits67% rewritten
20. 47validity of issued patents may be challenged. If a patent opposition is filed, we, or our licensors, may also need to participate in opposition proceedings involving our issued patentsNew
21. 48We 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
22. 49If we infringe the rights of others, we could be prevented from selling products or forced to pay damages
23. 50We enjoy restricted geographical protection with respect to certain patents
24. 51We may become subject to claims challenging inventorship or ownership of our patents and other intellectual property

RISKS RELATING TO OUR SECURITIES

1. 52We cannot assure you that our Common Stock will be liquid or that it will remain listed on the NYSE American100% rewritten
2. 53Our Common Stock is listed on the NYSE American. The NYSE American’s listing standards generally mandate that we meet certain requirements relating to stockholders’ equity, stock price, market capitalization, aggregate market value of publicly held shares and distribution requirementsNew
3. 54The market price of our Common Stock has been and may continue to be volatile and adversely affected by various factors
4. 55Our Charter 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
5. 56We do not intend to pay dividends in the foreseeable future on our Common Stock
6. 57Resales of our Common Stock in the public market by our stockholders may cause the market price of our common stock to fall21% rewritten
7. 58The shares of Common Stock offered under our current ATM Sales Agreement may be sold in “at the market” offerings, and investors who buy shares at different times will likely pay different prices