Theriva Biologics, Inc. filings document a Nevada clinical-stage biotechnology issuer with common stock listed on the NYSE American under TOVX. The company’s Form 8-K reports furnish quarterly and annual financial results, Regulation FD clinical and regulatory updates for VCN-01, and material-event disclosures tied to its oncology development programs.
Theriva Biologics proxy statements cover stockholder meeting mechanics, governance matters and shareholder approval proposals related to warrant exercises and potential common-stock issuance under NYSE American rules. Other 8-K disclosures record material definitive agreements, including the SYN-020 license arrangement, alongside capital-structure, voting and corporate-update information relevant to the company’s development-stage business.
Theriva Biologics, Inc. reported a first-quarter 2026 net loss attributable to common stockholders of $2.0 million, improving from $4.3 million a year earlier, on license revenue of $0.3 million from out-licensing SYN-020 to Rasayana Therapeutics.
Cash and cash equivalents were $14.4 million as of March 31 2026, with total assets of $38.2 million and an accumulated deficit of about $360.8 million. Net cash used in operating activities was $2.5 million for the quarter.
The company received $1.6 million from a Spanish R&D rebate program and raised about $2.3 million via at-the-market stock sales. Management discloses substantial doubt about the ability to continue as a going concern beyond the next 12 months without additional capital, despite cost reductions and an estimated cash runway into the first quarter of 2027.
Theriva Biologics reported first quarter 2026 results and updated progress on its lead programs. The company aligned with the FDA on the major elements of a pivotal Phase 3 trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma and plans a small dosing feasibility study in Spain in the second half of 2026.
VCN-01 is also being administered to retinoblastoma patients under a compassionate use program to inform a potential Phase 2/3 trial, with first patient enrollment targeted for December 2026 and rolling BLA submissions in 2029 if successful. For the quarter ended March 31, 2026, Theriva recorded $0.3 million in license revenue and a net loss of $2.0 million, improving from a $4.3 million loss a year earlier.
Research and development expenses fell sharply to $0.4 million as the VIRAGE Phase 2b PDAC trial wound down, while general and administrative expenses rose to $2.1 million on higher legal, investor relations, registration, and salary costs. Cash and cash equivalents were $14.4 million as of March 31, 2026, which the company states provides a cash runway into the first quarter of 2027.
Theriva Biologics, Inc. is calling a special stockholder meeting on June 5, 2026 to seek approval to issue up to 16,184,560 shares of common stock upon exercise of previously issued common stock purchase warrants. These new shares would be exercisable at $0.54 per share under an inducement agreement with institutional investors.
If all new warrants are exercised for cash, Theriva could receive up to approximately $8.7 million in gross proceeds, but existing holders would be diluted as total shares outstanding increase. Stockholders will also vote on allowing adjournment of the meeting to solicit more votes if support for the warrant exercise proposal is initially insufficient.
Theriva Biologics is seeking stockholder approval to issue up to 16,184,560 shares of Common Stock upon exercise of newly issued warrants. The Board says approval would permit up to approximately $8.7 million in gross cash proceeds if the New Warrants are exercised for cash at an initial exercise price of $0.54 per share. As of the Record Date, there were 45,892,668 shares outstanding. The New Warrants were issued on October 17, 2025, are exercisable only after stockholder approval, and expire on the fifth anniversary of the stockholder approval date. The Board also asks shareholders to approve an adjournment authority to reconvene if a quorum or sufficient votes are not obtained.
Theriva Biologics announced that it will present new data and subgroup analyses from the VIRAGE Phase 2b trial of VCN-01 plus gemcitabine/nab-paclitaxel in newly diagnosed metastatic pancreatic cancer at the AACR 2026 Annual Meeting in San Diego.
The company says tumor response, biomarker, and subgroup results support an immune-mediated mode of action for VCN-01 and show improved outcomes in treated patients, including those with liver metastases. Theriva reports alignment with the FDA and EMA on a proposed pivotal Phase 3 trial in first-line metastatic pancreatic ductal adenocarcinoma and is planning a smaller study to test more frequent and extended VCN-01 dosing.
Theriva Biologics, Inc. reported that its Special Meeting of Stockholders on April 9, 2026 could not be convened because too few shares were present to form a quorum. The meeting had been called to seek stockholder approval for warrant-related proposals.
The company will call a new stockholder meeting to again seek approval of a warrant exercise proposal and an adjournment proposal. Under an October 16, 2025 warrant inducement agreement, the company is seeking approval for the issuance of up to 16,184,560 shares of common stock upon exercise of certain new warrants, and must continue calling meetings every 60 days until approval is obtained or the warrants are no longer outstanding.
Theriva Biologics reported that the U.S. FDA provided general agreement with its proposed design for a pivotal Phase 3 trial of lead candidate VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC). The study will test VCN-01 plus gemcitabine/nab-paclitaxel versus chemotherapy plus placebo.
The Phase 3 plan closely follows the successful VIRAGE Phase 2 trial, where patients receiving two doses of VCN-01 with standard chemotherapy showed improved overall survival, progression-free survival, and duration of response compared to chemotherapy alone. The new trial is designed with repeat dosing and an adaptive design, including planned interim analyses.
FDA feedback, aligned with earlier EMA scientific advice, indicates that a single, high-quality, randomized, double-blind Phase 3 study could support a potential biologics license application for VCN-01 if results are positive. Theriva now aims to finalize the protocol and pursue development funding and partnership opportunities.
Theriva Biologics, Inc. has called a special stockholder meeting on April 9, 2026 to vote on two proposals. The main item seeks approval to issue up to 16,184,560 shares of common stock upon exercise of previously issued common stock purchase warrants at an exercise price of $0.54 per share, as required under NYSE American rules.
The company states that full cash exercise of these warrants could provide up to approximately $8.7 million in gross proceeds. As of the record date of February 27, 2026, there were 45,892,668 shares of common stock outstanding. The Board also seeks authority to adjourn the meeting if needed to obtain sufficient votes, and unanimously recommends voting in favor of both the warrant exercise and adjournment proposals.
Theriva Biologics, Inc. outlines its transformation into an oncology-focused, clinical-stage company centered on oncolytic adenovirus candidate VCN-01 (zabilugene almadenorepvec) for solid tumors, led by metastatic pancreatic ductal adenocarcinoma and retinoblastoma.
The 10-K highlights positive Phase 2b VIRAGE data in first-line metastatic pancreatic cancer, where VCN-01 plus gemcitabine/nab-paclitaxel improved overall and progression-free survival versus chemotherapy alone, with greater benefit in patients receiving two VCN-01 doses. Regulators in the U.S. and Europe granted Orphan Drug and Fast Track designations and provided guidance supporting a single pivotal Phase 3 trial using VCN-01 with gemcitabine/nab-paclitaxel.
Theriva also reports encouraging Phase 1 results for intravitreal VCN-01 in refractory retinoblastoma, including Orphan and Rare Pediatric Disease designations and a potential priority review voucher if ultimately approved. Beyond VCN-01, the company is advancing next-generation virus VCN-12 and a THERICEL suspension cell platform to scale viral manufacturing. In parallel, Theriva has de-emphasized its gastrointestinal pipeline, licensing SYN-020 globally to Rasayana Therapeutics and seeking partners for SYN-004, while retaining milestone, royalty and sublicense economics.
Theriva Biologics reported full-year 2025 results alongside a strategic licensing deal. The company licensed its Phase 2‑ready asset SYN-020 to Rasayana Therapeutics, with up to $38 million in potential milestones plus royalties, while Rasayana assumes future development costs.
Cash and cash equivalents were $13.1 million as of December 31, 2025, rising to about $15.2 million by February 26, 2026, which management expects to fund operations into the first quarter of 2027. General and administrative expenses were $15.4 million, up 109%, mainly from a $9.0 million contingent consideration adjustment tied to positive Phase 2b VCN‑01 PDAC data, while research and development expenses fell 28% to $8.6 million.
The company recorded a 2025 net loss of $23.7 million, slightly improved from $25.7 million in 2024, with net loss per share of $2.08. Its audited financial statements include an audit opinion with an explanatory paragraph about Theriva’s ability to continue as a going concern, highlighting reliance on future financing and successful execution of its development plans, including advancing lead oncolytic virus VCN‑01 toward pivotal trials in pancreatic ductal adenocarcinoma and retinoblastoma.