Theriva™ Biologics Reports Third Quarter 2025 Operational Highlights and Financial Results

Core Insights - Theriva Biologics has made significant progress in its oncology pipeline, particularly with VCN-01 for metastatic pancreatic ductal adenocarcinoma (PDAC) and VCN-12, a next-generation oncolytic virus [2][3] Financial Overview - As of September 30, 2025, cash and cash equivalents were $7.5 million, which increased to $15.5 million following recent capital raises, extending the cash runway into Q1 2027 [8] - General and administrative expenses decreased by 18% to $1.9 million for Q3 2025 compared to $2.3 million in Q3 2024, primarily due to reduced compensation costs [5] - Research and development expenses decreased by 7% to $2.6 million for Q3 2025 from approximately $2.7 million in Q3 2024, attributed to lower clinical trial expenses [6] Clinical Development - Expanded data from the VIRAGE Phase 2b trial showed that VCN-01 combined with standard-of-care chemotherapy improved overall survival (OS) and progression-free survival (PFS) in metastatic PDAC patients [3][12] - The company is pursuing regulatory interactions with the European Medicines Agency and the US FDA for a proposed Phase 3 study of VCN-01 plus gemcitabine/nab-paclitaxel as first-line treatment for metastatic PDAC [2] - VCN-12 demonstrated increased cell killing in preclinical studies compared to VCN-01 and showed a similar toxicity profile in animal studies [9] Pipeline and Future Plans - The company is designing a potential Phase 2/3 clinical trial for retinoblastoma, with discussions with regulators anticipated in the first half of 2026 [2] - Ongoing preclinical studies for VCN-12 are expected to confirm its efficacy and safety profile [9]