- EMA provided overall agreement with the proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC, including sample size, repeated dosing of VCN-01, and an adaptive design to potentially optimize trial timelines and outcomes - - Theriva to schedule an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design of a pivotal multinational Phase 3 clinical trial - - Theriva’s cash runway until Q1 2027 supports completion ...

Core Insights - Theriva Biologics has reported unusual trading activity in its common stock on October 24, 2025, but does not believe corrective actions are necessary [1] - The company has confirmed that there are no undisclosed material developments affecting its business [1] - On October 13, 2025, Theriva presented expanded data from its VIRAGE trial for VCN-01 at the ESMO 2025 Annual Congress [1] Company Overview - Theriva Biologics is a diversified clinical-stage company focused on developing therapeutics for cancer and related diseases in areas of high unmet need [2] - The company's subsidiary is developing an oncolytic adenovirus platform for intravenous, intravitreal, and antitumoral delivery to enhance tumor cell death and improve the efficacy of cancer therapies [2] - Key clinical-stage candidates include: - VCN-01 (zabilugene almadenorepvec), designed to selectively replicate within tumor cells and degrade the tumor stroma barrier [2] - SYN-004 (ribaxamase), aimed at degrading certain IV beta-lactam antibiotics in the GI tract to prevent microbiome damage and reduce acute graft-versus-host disease [2] - SYN-020, a recombinant oral formulation of intestinal alkaline phosphatase intended for local GI and systemic disease treatment [2]