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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. reports that it remains a clinical-stage oncology company focused on its oncolytic adenovirus platform, led by VCN‑01 for pancreatic cancer and retinoblastoma. For the six months ended June 30, 2026, it recorded $300,000 of license revenue from a new out‑license of SYN‑020 and a net loss of $5.3 million, narrower than the prior‑year period.
Cash and cash equivalents totaled $11.3 million, with total assets of $34.9 million and stockholders’ equity of $12.2 million. Management states there is substantial doubt about the company’s ability to continue as a going concern without additional capital or strategic transactions. A 2025 restructuring that reduced headcount by 32% is expected to save about $1.8 million annually and, together with other cuts, extend the cash runway into the first quarter of 2027, though current resources only fully cover certain limited trials and obligations.
During the period Theriva entered a license agreement with Rasayana Therapeutics that provided the $300,000 upfront payment and potential future milestones and royalties, continued to benefit from Spanish R&D tax credits, and modestly reduced its contingent consideration liability linked to the VCN acquisition to $9.8 million.
Theriva Biologics, Inc. reported second-quarter 2026 results and a clinical update. The company dosed the first patients in the VIRAGE2 Phase 2a study of VCN-01 in metastatic pancreatic ductal adenocarcinoma, evaluating more frequent repeated dosing to refine a regimen for potential future Phase 3 evaluation.
For the quarter ended June 30, 2026, general and administrative expenses were $2.0 million, down from $11.2 million a year earlier, largely due to a prior-year $9.2 million increase in the fair value of contingent consideration; R&D expenses declined to $1.3 million from $2.0 million. Net loss attributable to common stockholders was $3.2 million, or $0.07 per share, versus $13.1 million, or $1.93 per share, in the prior-year quarter.
Cash and cash equivalents totaled $11.3 million as of June 30, 2026, compared with $13.1 million at December 31, 2025, and the company states this provides a cash runway into the first quarter of 2027. An exploratory trial of SYN-004 remains open but enrollment is paused pending grant, partnership or other funding.
Theriva Biologics announced dosing of the first patient in VIRAGE2, a Phase 2a, proof-of-concept trial testing more frequent repeated dosing of its oncolytic adenovirus VCN-01 in first-line metastatic pancreatic ductal adenocarcinoma patients receiving standard gemcitabine/nab-paclitaxel chemotherapy. The single-arm, open-label study will enroll 6 evaluable patients at a site in Spain, each planned to receive at least three VCN-01 “macrocycles” about two months apart. Primary objectives focus on safety and VCN-01 viral genome levels in blood, with secondary endpoints including response rates and survival.
Enrollment is expected to complete in H2 2026, with initial pharmacodynamic and safety/tolerability data anticipated by Q3 2027. VIRAGE2 builds on the earlier VIRAGE Phase 2b study in metastatic pancreatic cancer, where patients given two VCN-01 doses plus chemotherapy exhibited improved overall survival, progression-free survival, and duration of response versus chemotherapy alone, and on EMA and FDA feedback supporting exploration of more frequent dosing to guide a potential future pivotal Phase 3 trial.
Theriva Biologics, Inc. reported the results of its 2026 Annual Meeting of Stockholders held on August 3, 2026. Stockholders approved Amendment No. 4 to the 2020 Stock Incentive Plan, increasing the maximum shares of common stock issuable under the plan from 4,500,000 to 6,500,000.
Four directors were elected to serve until the next annual meeting, and BDO USA, P.C. was ratified as the Company’s independent registered public accounting firm for the year ending December 31, 2026. Stockholders also approved an amendment to increase the number of authorized shares of common stock, the issuance of common stock upon exercise of outstanding warrants, and a proposal permitting adjournment of the meeting, although adjournment was ultimately not needed.
Theriva Biologics announced that the Spanish Agency of Medicines and Medical Devices has authorized initiation of VIRAGE2, a Phase IIa proof-of-concept trial in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). The study will test more frequent dosing of the oncolytic adenovirus VCN-01 with gemcitabine/nab-paclitaxel chemotherapy.
VIRAGE2 will enroll 6 evaluable patients at a single site in Spain and is designed to give at least three doses of VCN-01 two months apart. It builds on the 112-patient VIRAGE Phase 2b trial, where two VCN-01 doses given three months apart improved overall survival, progression free survival and duration of response versus one dose or chemotherapy alone. Results from VIRAGE2 are expected to refine the VCN-01 dosing regimen for potential use in a future pivotal Phase 3 trial.
Theriva Biologics, Inc. is asking stockholders to approve several governance and capital structure changes at its 2026 Annual Meeting on August 3, 2026. Investors will vote on electing four directors, ratifying BDO USA, P.C. as auditor for 2026, and multiple share-related proposals.
The company seeks to amend its 2020 Stock Incentive Plan so it can grant up to 6,500,000 shares of common stock and to amend its Articles of Incorporation to increase authorized common stock to 450,000,000 shares, at the Board’s discretion. Stockholders are also asked to approve the issuance of up to 16,184,560 shares upon exercise of warrants issued in an October 17, 2025 private placement.
As of the June 23, 2026 record date, 45,892,668 shares of common stock were outstanding, each entitled to one vote. The Board recommends voting “FOR” all six proposals, including an adjournment proposal that would allow extra time to solicit votes if support for key share and warrant items is initially insufficient.
Theriva Biologics, Inc. is requesting stockholder votes at its 2026 Annual Meeting on August 3, 2026 to elect four directors and approve several capital‑related proposals. Key items include an increase in the 2020 Stock Incentive Plan to 6,500,000 shares, an amendment to authorize up to 450,000,000 shares of Common Stock, and approval to issue up to 16,184,560 shares upon exercise of certain warrants.
The proxy materials state there were 45,892,668 shares outstanding as of June 23, 2026, the Record Date. The Board also asks ratification of BDO USA, P.C. as auditor and seeks authority to adjourn if additional solicitation is needed. Voting instructions, quorum rules, and director and compensation disclosures are included in the accompanying proxy statement.
Theriva Biologics reported that results from its Phase 1 clinical trial of VCN-01 in metastatic, immunotherapy‑refractory Head & Neck Squamous Cell Carcinoma were published online in Clinical Cancer Research. Prolonged overall survival was observed in heavily pre-treated patients who received intravenous VCN-01 before the immune checkpoint inhibitor durvalumab.
The trial enrolled 20 adults: 6 received low-dose VCN-01 four hours before durvalumab, 8 received low-dose VCN-01 14 days before durvalumab, and 6 received high-dose VCN-01 14 days before durvalumab. Pharmacokinetic, biopsy, radiomic and transcriptomic data, plus increased PD-L1 positive T‑cells, supported the proposed stroma‑degrading and immune‑enhancing mechanism. The company also highlighted ongoing development of its VCN-01 platform and the need for additional funding to initiate the third cohort of an exploratory SYN‑004 trial.
Theriva Biologics, Inc. reported that it could not convene its Special Meeting of Stockholders on June 5, 2026 because too few shares were present to form a quorum. The meeting had been called to seek stockholder approval for the issuance of up to 16,184,560 shares of common stock upon exercise of certain common stock purchase warrants issued under an October 16, 2025 inducement agreement.
The company plans to call a new stockholder meeting and will file and mail updated proxy materials with the meeting details. Under the inducement agreement, unless investors waive this requirement, Theriva must continue to call additional stockholder meetings every 60 days to seek the necessary approval until it is obtained or the warrants are no longer outstanding.