Theriva™ Biologics Reports Full-Year 2025 Operational Highlights and Financial Results

Core Insights - Theriva Biologics, Inc. is advancing its clinical development of VCN-01 for pancreatic ductal adenocarcinoma (PDAC) and retinoblastoma, with plans for pivotal trials in 2026 [2][5] Financial Results - For the year ended December 31, 2025, general and administrative expenses rose to $15.4 million, a 109% increase from $7.4 million in 2024, primarily due to a contingent consideration adjustment of $9.0 million related to the VIRAGE Phase 2b clinical trial [7] - Research and development expenses decreased to $8.6 million in 2025 from $12.0 million in 2024, a 28% reduction attributed to lower clinical trial costs [8] - Cash and cash equivalents were $13.1 million as of December 31, 2025, up from $11.6 million in 2024, with a current cash position of approximately $15.2 million as of February 26, 2026, expected to fund operations into Q1 2027 [9] Licensing and Partnerships - Theriva licensed SYN-020 to Rasayana Therapeutics for $300,000 upfront and potential milestones of up to $38 million, including royalties on commercial sales [3][4] - The company is engaging in partnership discussions for additional innovative drug candidates in its portfolio [2] Clinical Development Updates - The European Medicines Agency (EMA) provided positive feedback on the Phase 3 trial design for VCN-01 in combination with gemcitabine/nab-paclitaxel for metastatic PDAC [5] - An End-of-Phase 2 meeting with the FDA is scheduled for the first half of 2026 to finalize the design for a multinational pivotal Phase 3 trial in PDAC [5] - VCN-01 has received Orphan Drug and Rare Pediatric Disease designations for retinoblastoma, with further discussions planned with the FDA and EMA in 2026 [5] Product Information - VCN-01 is an oncolytic adenovirus designed to selectively replicate within tumor cells and degrade tumor stroma, enhancing the efficacy of co-administered therapies [11] - SYN-020 is a recombinant bovine intestinal alkaline phosphatase aimed at addressing metabolic and inflammatory disorders, now poised to enter Phase 2 clinical testing [12]