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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 filed a prospectus supplement disclosing an amendment to certain existing warrants. On October 16, 2025, the company reduced the exercise price on warrants to purchase up to 1,385,000 shares of common stock from $2.00 to $0.54 per share.
This supplement updates the company’s previously effective S-1 prospectus. The change applies only to specified “Existing Warrants” held by certain holders. Theriva’s common stock trades on the NYSE Capital Market under the symbol TOVX, and the closing price was $0.84 per share on October 15, 2025.
Theriva Biologics (TOVX) filed a prospectus supplement to disclose an amendment to certain outstanding common warrants. On October 16, 2025, the company and certain holders agreed to reduce the exercise price on Existing Warrants covering up to 6,727,280 shares of common stock from $1.10 to $0.54 per share. The supplement updates the previously effective S-1 prospectus tied to the May 2025 best efforts offering. Theriva’s common stock closed at $0.84 on October 15, 2025 on the NYSE Capital Market under the symbol TOVX.
Theriva Biologics (TOVX) furnished an update on clinical data to be presented on October 20, 2025 at ESMO 2025 from the VIRAGE Phase 2b trial in metastatic pancreatic ductal adenocarcinoma. The study compared standard gemcitabine/nab‑paclitaxel (GA; Arm I) to VCN‑01 plus GA (Arm II).
In the full analysis set, median overall survival was 10.8 months for Arm II vs 8.6 months for Arm I (HR 0.57; 95% CI 0.34–0.96; P=0.055). Progression‑free survival was 7.0 vs 4.6 months (HR 0.55; 95% CI 0.34–0.88; P=0.011), and duration of response was 11.2 vs 5.4 months (HR 0.22; 95% CI 0.08–0.62; P=0.004). In a subgroup receiving two doses of VCN‑01 and starting GA cycle 4, overall survival was 14.8 vs 11.6 months (HR 0.44; 95% CI 0.21–0.92; P=0.046), and PFS was 11.2 vs 7.4 months (HR 0.48; 95% CI 0.25–0.91; P=0.017).
The company reports the study met its primary endpoints and VCN‑01 was well tolerated; all VCN‑01‑related serious adverse events (n=13) resolved, with flu‑like symptoms (13.2%), transaminase increases (5.7%), and drug‑induced liver injury (3.8%) most common. A separate poster on previously reported SYN‑004 data will appear at IDWeek 2025.
Theriva Biologics, Inc. reported new preclinical results for its next-generation oncolytic adenovirus VCN-12, developed within the VCN-X discovery program. The data were presented at the 32nd Annual Congress of the European Society of Gene & Cell Therapy and the full presentation is available as Exhibit 99.1.
VCN-12 uses the same capsid as the company’s lead clinical candidate VCN-01 but is engineered to increase stroma degradation by replacing human hyaluronidase PH20 with a more active bee hyaluronidase, and to boost tumor cell lysis by expressing the pore-forming protein parasporin-2. In vitro, VCN-12 showed increased cancer cell killing and higher hyaluronidase activity compared to VCN-01. In animal models, intravenous VCN-12 had a similar toxicity profile to VCN-01, while intratumoral dosing significantly reduced tumor growth versus VCN-01 in immunocompetent hamsters with HP-1 pancreatic tumors.
The antitumor effect was seen in both injected tumors and separate tumors implanted later but not injected. Complete regression of the first tumor occurred in two of nine hamsters, and the second implanted tumors did not grow in these animals. A persistent immune response appeared to prevent new tumor establishment when HP-1 cells were implanted again 43 days after VCN-12 treatment in these responders. The company plans further preclinical studies to expand on these findings.
Theriva Biologics, Inc. (TOVX) filed a Form S-8 to register shares for its employee benefit plan and related amendments. After prior registrations and two reverse stock splits (a 1-for-10 in 2022 and a 1-for-25 in 2024), the aggregate number of common shares available under the amended 2020 Stock Incentive Plan is 2,500,000 shares. The filing lists prior S-8 registrations, plan amendments, grant agreement forms, and certificates of amendment incorporated by reference.
Theriva Biologics, Inc. filed a report describing new communications about its oncolytic virus pipeline. On October 6, 2025, the company issued a press release announcing the presentation of preclinical data for VCN-12, a next-generation oncolytic adenovirus from its VCN-X discovery program, at the 32nd Annual Congress of the European Society of Gene & Cell Therapy.
The same press release, and an additional disclosure, highlighted publication of results from a preclinical study by collaborators at the University of Navarra on intracranial administration of VCN-01, which supports further development of VCN-01 as a potential treatment for brain tumors. The information related to the press release is furnished, not filed, and is not incorporated by reference into other SEC filings.
Theriva Biologics, Inc. approved a restructuring plan on September 28, 2025 to resize the company and focus resources on business development, licensing, and upcoming regulatory meetings for its lead oncolytic virus candidate VCN-01 in metastatic pancreatic ductal adenocarcinoma and retinoblastoma.
As part of the plan, Theriva implemented a workforce reduction on September 30, 2025, eliminating approximately seven positions, or about 32% of its global workforce. The company expects to record about $520,000 of charges in the fourth quarter of 2025, primarily for cash severance and benefits over roughly three months.
The restructuring is expected to reduce annual compensation and benefits costs by about $2.0 million. Together with additional anticipated operating cost reductions, Theriva believes this will extend its cash runway into the second quarter of 2026, though it cautions that actual charges and savings may differ materially due to legal and operational factors.
Theriva Biologics, Inc. reported results of its 2025 annual stockholder meeting held on August 29, 2025. Stockholders approved Amendment No. 3 to the 2020 Stock Incentive Plan, increasing the number of shares of common stock the company may grant under the plan from 2,500,000 to 4,500,000, expanding the pool available for equity-based compensation.
Four directors – Jeffrey J. Kraws, Steven A. Shallcross, John Monahan and Jeffrey Wolf – were re-elected to serve until the next annual meeting. Stockholders also ratified BDO USA, P.C. as independent registered public accounting firm for the year ending December 31, 2025, approved on an advisory basis the compensation of named executive officers, and supported holding future advisory votes on executive pay every three years. The board determined to follow the three-year frequency in line with this vote.
Theriva Biologics, Inc. filed a Form 10-Q reporting total assets of $35.83 million and cash and cash equivalents of $12.12 million as of June 30, 2025. The company recorded a quarterly net loss of $13.06 million and a six-month net loss of $17.38 million, driven by a sharp increase in general and administrative expenses and continued R&D spending. In the period the company met primary survival and safety endpoints in its VIRAGE Phase 2b trial for lead candidate VCN-01, which triggered a contractual milestone obligation and contributed to an increase in contingent consideration to $10.16 million. The acquired in-process R&D (IPR&D) asset is carried at $19.62 million and was tested for impairment with no charge recorded. The company raised gross proceeds of approximately $7.5 million in a May 2025 offering and had cash of about $9.5 million in early August 2025, with management stating that current cash is expected to be sufficient into the first quarter of 2026. The 10-Q discloses substantial doubt about the Company’s ability to continue as a going concern and the need to obtain additional financing or strategic transactions to fund planned clinical activities.
Theriva Biologics, Inc. furnished a press release containing financial information for the quarter ended June 30, 2025, and attached that press release to this Current Report as Exhibit 99.1. The report also identifies an interactive data file as Exhibit 104.
The company states that the information in Item 2.02 and the attached press release is furnished and shall not be deemed to be "filed" for purposes of Section 18 of the Exchange Act and will not be incorporated by reference into other SEC filings. The Form 8-K is signed by Steven A. Shallcross, Chief Executive Officer and Chief Financial Officer. No financial figures are included in the Form text provided here.