Special Note Regarding Forward-Looking Statements
This Annual Report on Form 10-K (this “Annual Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve substantial risks and uncertainties. The forward-looking statements are contained principally in Part I, Item 1. “Business,” Part I, Item 1A. “Risk Factors,” and Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” but are also contained elsewhere in this Annual Report. In some cases you can identify forward-looking statements by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based on our current beliefs, expectations, and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and generally beyond our control, that could cause actual results to differ materially from those expressed, projected or implied in or by the forward-looking statements.
You should refer to Item 1A. “Risk Factors” section of this Annual Report for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We do not undertake any obligation to update any forward-looking statements.
Unless the context requires otherwise, references to “we,” “us,” “our,” “Theriva,” and “Theriva Biologics,” refer to Theriva Biologics, Inc. and its subsidiaries.
On October 26, 2024, we effected a one for twenty-five reverse stock split (the “Reverse Stock Split”) of our authorized, issued and outstanding common stock, par value $0.001 per share (“Common Stock”). Unless otherwise noted, all references to share amounts from dates prior to completion of the Reverse Stock Split that are included in this Annual Report have been retroactively restated to reflect the Reverse Stock Split.
Summary Risk Factors
The following is a summary of the key risks relating to the Company. A more detailed description of each of the risks can be found below under Item 1A. Risk Factors.
Risks Related to Our Financial Position and Capital Requirements
| ● | Our consolidated financial statements as of December 31, 2025 have been prepared assuming that we will continue as a going concern for the next twelve months. |
| ● | We will need to raise additional capital for our planned clinical trials. |
| ● | We expect to continue to incur significant operating and capital expenditures and we will need additional funds. |
| ● | The actual amount of funds we will need to operate is subject to many risk factors, some of which are beyond our control. |
| ● | We 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. |
| ● | We cannot provide assurances that additional material weaknesses will not occur in the future. |
| ● | We expect to seek to raise additional capital in the future, which may be dilutive to stockholders. |
| ● | Our operating results may fluctuate significantly, which makes our future operating results difficult to predict. |
| ● | If our acquired intangible assets become impaired, we may be required to record a significant charge to earnings. |
| ● | A prolonged U.S. federal government shutdown could materially and adversely affect our business and operations. |
| ● | Federal budget and debt - ceiling disputes may adversely affect capital markets and our financing activities. |
Risks Related to Our Business
| ● | Prior to 2022 we did not conduct 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. |
| ● | The development and commercialization of oncolytic viruses have experienced certain challenges. |
| ● | Our research and development efforts may not succeed in developing successful products and technologies. |
| ● | We may not realize the benefits from any strategic alliances we form or licensing arrangements we enter into. |
| ● | We may not be able to retain rights we license or relationships needed to develop, manufacture, and market our products. |
| ● | We may incur additional expenses in connection with our licenses, collaboration arrangements and development efforts. |
| ● | Developments by competitors may render our products or technologies obsolete or non-competitive. |
| ● | We 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. |
| ● | If the parties we depend on for product manufacturing are unsuccessful in providing adequate drug supply, or if existing drug supply becomes unusable, it may delay or impair our ability to develop, manufacture and market our product candidates. |
| ● | Any problems obtaining the drugs that we administer in combination with VCN-01, could result in a trial delay or interruption. |
| ● | We may fail to retain or recruit necessary personnel, and we may be unable to secure the services of consultants. |
| ● | Inadequate funding for certain government agencies could negatively impact our business and timelines. |
| ● | Global health crises or other disruptions to global trade and supply lines may adversely affect our planned operations. |
| ● | Business disruptions could seriously harm our future revenue and financial condition and increase costs and expenses. |
| ● | Unfavorable economic conditions could adversely affect our business, financial condition or results of operations. |
| ● | We rely extensively on our information technology systems which are vulnerable to risks. |
| ● | Our business and operations would suffer in the event of computer system failures. |
| ● | Failure to maintain the security of information relating to our patients, customers, employees and suppliers could expose us to litigation, government enforcement actions and costly response measures and harm our reputation. |
| ● | We may face particular data protection, data security and privacy risks in connection with data protection regulations. |
Regulatory Risks
| ● | If we do not obtain the necessary regulatory approvals we may not be able to develop or sell our product candidates. |
| ● | Clinical trials are very expensive, time consuming, and difficult to design and implement. |
| ● | The results of our clinical trials may not support our proposed product candidate claims and the results of preclinical studies and completed clinical trials are not necessarily predictive of future results. |
| ● | Difficulties in enrolling, retaining, or completing patients in our clinical trials or delays in enrollment are expected to result in our clinical development activities being delayed or otherwise adversely affected. |
| ● | Patients who are administered our product candidates may experience unexpected side effects or other safety risks that could cause a halt in clinical development, preclude approval or limit the commercial potential of the product candidate. |
| ● | It is possible that we may not be able to obtain or maintain orphan drug designation or exclusivity for our drug candidates. |
| ● | Fast Track designation by the FDA does not assure FDA approval. |
| ● | We may not be eligible to receive a priority review voucher despite rare pediatric disease designation for VCN-01 |
| ● | Our product candidates, if approved for sale, may not gain acceptance among physicians, patients and the medical community. |
| ● | We depend on third parties, including researchers and sublicensees, who are not under our control. |
| ● | We currently have no marketing, sales or distribution organization and have no experience in marketing products as a company. |
| ● | Reimbursement may not be available for our product candidates, which would impede sales. |
| ● | Healthcare reform measures could hinder or prevent our product candidates’ commercial success. |
| ● | If 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. |
| ● | If 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 |
| ● | If product liability lawsuits are successfully brought against us, we may incur substantial liabilities. |
| ● | We 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 results. |
Intellectual Property Risks
| ● | We rely on patent applications 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. |
| ● | We may incur substantial costs as a result of litigation or proceedings relating to protecting our intellectual property rights. |
| ● | If we infringe the rights of others, we could be prevented from selling products or forced to pay damages. |
| ● | We enjoy restricted geographical protection with respect to certain patents. |
| ● | We may become subject to claims challenging inventorship, ownership or validity of our intellectual property |
Risks Related to Our Securities
| ● | We cannot assure you that our Common Stock will be liquid or that it will remain listed on the NYSE American exchange. |
| ● | We expect to seek to raise additional capital in the future, which may be dilutive to stockholders. |
| ● | The market price of our Common Stock has been and may continue to be volatile and adversely affected by various factors. |
| ● | Our Articles of Incorporation and bylaws and Nevada law have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline. |
| ● | We do not intend to pay dividends in the foreseeable future on our Common Stock. |
| ● | Resales of our stock in the public market by our stockholders may cause the market price of our stock to fall. |
| ● | The 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. |
