Welcome to our dedicated page for THERIVA BIOLOGICS SEC filings (Ticker: TOVX), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Theriva Biologics, Inc. (TOVX) SEC filings page provides access to the company’s official regulatory documents filed with the U.S. Securities and Exchange Commission. These filings offer detailed information about Theriva’s clinical-stage programs, capital structure, and corporate actions, complementing its press releases and scientific presentations.
Investors can review Form 10-K and Form 10-Q annual and quarterly reports for discussions of risk factors, research and development activities, and financial condition related to programs such as VCN-01, SYN-004 (ribaxamase), SYN-020, and the VCN-X discovery efforts. Current reports on Form 8-K describe material events, including clinical data announcements, regulatory feedback from agencies such as the European Medicines Agency, warrant inducement agreements, public offerings, and at-the-market sales agreements.
Theriva’s proxy statements on Schedule 14A outline matters submitted to stockholders, such as proposals to approve the issuance of additional common shares upon exercise of warrants issued in private placements. These documents explain voting mechanics, record dates, and the rationale for share authorization requests tied to financing transactions.
Forms related to securities offerings, such as registration statements and prospectus supplements referenced in 8-K filings, describe the terms of public offerings of common stock and warrants, as well as at-the-market programs through placement agents. Together, these filings help clarify how Theriva funds the development of its clinical pipeline.
On this page, Stock Titan pairs Theriva’s SEC filings with AI-powered summaries that highlight key points, such as changes in capital structure, new clinical or regulatory disclosures, and important risk factor updates. Real-time updates from EDGAR, along with structured access to historical filings, allow users to monitor how Theriva’s regulatory and financing profile evolves alongside its investigational therapies.
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.
Theriva Biologics, Inc. is asking shareholders to approve the issuance of up to 16,184,560 shares of common stock upon exercise of newly issued common stock purchase warrants, a proposal tied to a warrant inducement completed on October 17, 2025. The board says approval would permit exercise of the New Warrants at a stated exercise price of $0.54 per share and could generate up to $8.7 million in gross proceeds if fully exercised for cash.
The New Warrants were issued as part of an inducement arrangement and are exercisable only after stockholder approval; they include beneficial ownership caps of 4.99% (or, at holder election, 9.99%) and typical adjustment and fundamental-transaction provisions. As of the record date there were 45,892,668 shares outstanding.
Theriva Biologics has out-licensed its SYN-020 program to Rasayana Therapeutics under an exclusive worldwide agreement. Theriva received a $300,000 upfront payment and is eligible for up to $16,000,000 in development milestones and up to $22,000,000 in sales milestones, plus tiered low- to mid-single-digit royalties on net sales and a share of sublicense revenue.
Rasayana will assume all responsibility and costs for developing and commercializing SYN-020, which has completed Phase 1 and is planned to enter Phase 2. The deal allows Theriva to focus resources on its lead pancreatic cancer program VCN-01 while retaining economic participation in any future SYN-020 success.
Theriva Biologics, Inc. was unable to convene its Special Meeting of Stockholders on February 11, 2026 because not enough shares were present to form a quorum. The meeting was intended to obtain stockholder approval for issuing up to 16,184,560 shares of common stock upon exercise of certain New Warrants under an October 16, 2025 inducement agreement.
The company plans to call a new stockholder meeting to seek this approval and will announce the date and time and send new proxy materials. Under the inducement agreement, unless investors waive the requirement, Theriva must call another meeting every 60 days until stockholder approval is obtained or the New Warrants are no longer outstanding.
Theriva Biologics, Inc.
The presentation includes forward-looking statements language under the Private Securities Litigation Reform Act of 1995, indicating that it discusses expectations and plans in addition to historical information. No new financial results or major transactions are described in this report itself; it primarily alerts investors to the availability of the updated presentation.