Core Insights - Theriva Biologics has completed enrollment in the VIRAGE Phase 2b clinical trial for VCN-01 targeting metastatic pancreatic ductal adenocarcinoma (PDAC), with topline data expected in Q2 2025 [1][2] - The development of VCN-01 has been supported by the FDA's Fast Track designation for PDAC and Rare Pediatric Disease designation for retinoblastoma [1][4] - The company has received guidance from the FDA and EMA regarding the design of a potential Phase 3 trial for VCN-01 in combination with standard chemotherapy for metastatic PDAC [1][4] Clinical Development Updates - The VIRAGE trial achieved its target enrollment of 92 evaluable patients, and the outcomes of a second Data Monitoring Committee review of safety data are anticipated in Q2 2025 [4] - Positive topline data from a Phase 1 trial of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma was announced in April 2024 [4] - VCN-01 received Rare Pediatric Drug Designation from the FDA and Orphan Medicinal Product Designation from the European Commission for retinoblastoma treatment [4] Financial Performance - For the year ended December 31, 2024, general and administrative expenses increased to 7.1 million in 2023 [8] - Research and development expenses decreased to 14.3 million in 2023, primarily due to lower clinical trial expenses [9] - The company reported a net loss of 18.3 million in 2023 [18] Cash Position - As of December 31, 2024, cash and cash equivalents totaled 23.2 million as of December 31, 2023 [11] - The company recognized a tax credit receivable of 3.2 million from the Spanish government for R&D expenses [7][11] Business Development - Theriva Biologics was awarded €2.28 million (approximately 2.54 million) in manufacturing funding from the Spanish government's National Knowledge Transfer Program [6] - The company is focusing on advancing its clinical development of VCN-01 while seeking grant funding or partnerships for the SYN-004 development program [5]
Theriva™ Biologics Reports Full-Year 2024 Operational Highlights and Financial Results