Theriva Biologics, Inc. 8-K Filing

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Key Financial Figures

• $0.001 — registered Common stock, par value $0.001 per share TOVX NYSE American Indica

Filing Documents

• tm2534356d1_8k.htm (8-K) — 33KB
• tm2534356d1_ex99-1.htm (EX-99.1) — 19KB
• tm2534356d_ex99-1img01.jpg (GRAPHIC) — 4KB
• 0001104659-25-124523.txt ( ) — 228KB
• syn-20251229.xsd (EX-101.SCH) — 3KB
• syn-20251229_lab.xml (EX-101.LAB) — 33KB
• syn-20251229_pre.xml (EX-101.PRE) — 22KB
• tm2534356d1_8k_htm.xml (XML) — 3KB

01. Regulation

Item 7.01. Regulation FD Disclosure. On December 29, 2025, Theriva Biologics, Inc. (the "Company") issued a press release announcing receipt of Scientific Advice from the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") on the design of a Phase 3 clinical trial of lead clinical candidate VCN-01 in combination with gemcitabine/nab-paclitaxel standard-of-care ("SoC") chemotherapy for the first-line treatment of metastatic pancreatic adenocarcinoma ("PDAC"). The Company has previously reported the results of the VIRAGE randomized, controlled Phase 2b clinical trial, demonstrating that PDAC patients in the VCN-01 plus gemcitabine/nab-paclitaxel SoC treatment arm demonstrated increased overall survival, progression free survival, and duration of response compared to patients in the control arm treated with gemcitabine/nab-paclitaxel SoC alone. Even greater increases in these parameters were observed in patients who received 2 doses of VCN-01 administered 3 months apart. CHMP advised that a potential future marketing authorization application ("MAA") for VCN-01 in metastatic PDAC could be supported by the Company's proposed clinical development strategy comprising a single, high-quality, double-blinded, randomized, placebo-controlled Phase 3 trial if it demonstrates a compelling benefit-risk ratio with VCN-01 plus gemcitabine/nab-paclitaxel SoC compared to gemcitabine/nab-paclitaxel SoC alone. The CHMP scientific advice included agreement on the proposed inclusion/exclusion criteria, primary endpoint (overall survival), secondary endpoints (including progression free survival, duration of response, and patient reported outcomes), sample size, and the use of an adaptive design to potentially optimize trial timelines and outcomes. Importantly, CHMP recognized the increased improvement in overall survival of patients receiving 2 doses of VCN-01 in the VIRAGE study, and agreed with the proposed dosing of VCN-01 and gemcitabin

01. Other Events

Item 8.01. Other Events. On December 29, 2025, the Company issued a press release announcing receipt of Scientific Advice from the CHMP of the EMA on the design of a Phase 3 clinical trial of lead clinical candidate VCN-01 in combination with gemcitabine/nab-paclitaxel SoC chemotherapy for the first-line treatment of metastatic PDAC. The Company has previously reported the results of the VIRAGE randomized, controlled Phase 2b clinical trial, demonstrating that PDAC patients in the VCN-01 plus gemcitabine/nab-paclitaxel SoC treatment arm demonstrated increased overall survival, progression free survival, and duration of response compared to patients in the control arm treated with gemcitabine/nab-paclitaxel SoC alone. Even greater increases in these parameters were observed in patients who received 2 doses of VCN-01 administered 3 months apart. CHMP advised that a potential future marketing authorization application ("MAA") for VCN-01 in metastatic PDAC could be supported by the Company's proposed clinical development strategy comprising a single, high-quality, double-blinded, randomized, placebo-controlled Phase 3 trial if it demonstrates a compelling benefit-risk ratio with VCN-01 plus gemcitabine/nab-paclitaxel SoC compared to gemcitabine/nab-paclitaxel SoC alone. The CHMP scientific advice included agreement on the proposed inclusion/exclusion criteria, primary endpoint (overall survival), secondary endpoints (including progression free survival, duration of response, and patient reported outcomes), sample size, and the use of an adaptive design to potentially optimize trial timelines and outcomes. Importantly, CHMP recognized the increased improvement in overall survival of patients receiving 2 doses of VCN-01 in the VIRAGE study, and agreed with the proposed dosing of VCN-01 and gemcitabine/nab-paclitaxel in repeated "macrocycles", enabling more than 2 doses of VCN-01 to be administered in the Phase 3 trial. CHMP further suggested that more frequent dosing o

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits. Exhibit Number Description 99.1 Press Release issued by Theriva Biologics, Inc., dated December 29, 2025 104 Cover Page Interactive Data File (embedded within the XBRL document) -2-

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: December 29, 2025 THERIVA BIOLOGICS, INC. By: /s/ Steven A. Shallcross Name: Steven A. Shallcross Title: Chief Executive Officer and Chief Financial Officer -3-

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