THERIVA BIOLOGICS INC SEC Filings

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. (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 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.