EMA provides positive Scientific Advice on Theriva's Phase 3 trial design for VCN-01 in metastatic PDAC

Theriva Biologics, Inc.

EMA CHMP agreed on Phase 3 design for VCN-01 + gem/nab-paclitaxel vs SoC; primary endpoint overall survival.
CHMP agreed on repeated dosing in macrocycles, enabling >2 doses; recognized VIRAGE survival benefit.
Theriva plans End-of-Phase 2 meeting with FDA in H1 2026 to finalize multinational Phase 3 trial.
Cash runway into Q1 2027 ($15.5M at Nov 10, 2025) supports regulatory activities and partnering.
VCN-01 has Orphan Drug designation in EU/US, Fast Track in US, and Rare Pediatric Disease for retinoblastoma.

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