Core Insights - Theriva Biologics has received scientific advice from the EMA regarding the Phase 3 clinical trial design for VCN-01 in combination with gemcitabine/nab-paclitaxel for treating metastatic PDAC [1][3] - The company plans to hold an End-of-Phase 2 meeting with the FDA in H1 2026 to finalize the design of a pivotal multinational Phase 3 clinical trial [1][4] - Theriva's cash runway extends until Q1 2027, allowing for the completion of regulatory activities and protocol development for VCN-01 trials [1][4] Clinical Trial Developments - The Phase 2b clinical trial (VIRAGE) showed that patients receiving VCN-01 with standard chemotherapy had improved overall survival and progression-free survival compared to those receiving chemotherapy alone [2] - The CHMP supports a single, high-quality, double-blinded, randomized, placebo-controlled Phase 3 trial if it demonstrates a compelling benefit-risk ratio [3] - The proposed trial design includes adaptive elements, primary endpoint of overall survival, and secondary endpoints such as progression-free survival and duration of response [3] Regulatory and Financial Outlook - The company is encouraged by the EMA's agreement on the dosing regimen for VCN-01, which may enhance survival outcomes [4] - Theriva had $15.5 million in cash and equivalents as of November 10, 2025, providing sufficient funds to support ongoing regulatory interactions and potential partnerships [4] - The company aims to seek regulatory advice for a potential Phase 2/3 trial of VCN-01 in retinoblastoma in 2026 [4]

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]