- VCN-01 expanded mPDAC data from VIRAGE Phase 2b trial to be presented at ESMO 2025 - - SYN-004 Interim blinded safety and pharmacokinetic data to be presented at IDWeek 2025 - Rockville, Md., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced upcoming presentations at the European Society for Medical O ...

Core Viewpoint - Theriva Biologics reported significant progress in its clinical trials, particularly with its lead asset VCN-01, which has shown positive results in treating metastatic pancreatic cancer and is preparing for a potential Phase 3 trial [2][5]. Financial Results - As of June 30, 2025, cash and cash equivalents were $12.1 million, an increase from $11.6 million as of December 31, 2024, with an expected cash runway into Q1 2026 [9]. - General and administrative expenses surged to $11.2 million for Q2 2025, up 662% from $1.5 million in Q2 2024, primarily due to a $9.2 million increase in fair value of contingent consideration related to the VIRAGE Phase 2b trial [4]. - Research and development expenses decreased to $2.0 million for Q2 2025, down 34% from approximately $3.0 million in Q2 2024, attributed to lower clinical trial expenses [7]. Clinical Development - The Phase 2b VIRAGE trial of VCN-01 demonstrated improved overall survival, progression-free survival, and duration of response in metastatic pancreatic ductal adenocarcinoma (PDAC) patients compared to standard chemotherapy [5][12]. - The company is preparing a study protocol for a potential Phase 3 clinical trial and is advancing the manufacturing scale-up of VCN-01 [2][4]. - Safety and clinical outcomes of VCN-01 in refractory retinoblastoma patients were presented at the ASCO Annual Meeting [3]. Upcoming Milestones - Expanded data from the VIRAGE trial is set to be presented at the ESMO 2025 Congress in October [5]. - The company is initiating strategic outreach to identify potential partners for the late-stage clinical development of VCN-01 [2]. Company Overview - Theriva Biologics is focused on developing therapeutics for cancer and related diseases, with a proprietary oncolytic adenovirus platform designed to enhance the efficacy of existing cancer treatments [15].

Core Insights - Theriva Biologics announced positive topline outcomes from the VIRAGE Phase 2b clinical trial for VCN-01 in combination with standard-of-care chemotherapy for metastatic pancreatic ductal adenocarcinoma (PDAC) patients [1][3] Company Overview - Theriva Biologics is a diversified clinical-stage company focused on developing therapeutics for cancer and related diseases, with its lead product candidate being VCN-01, an oncolytic adenovirus [10][11] Clinical Trial Results - The VIRAGE trial involved 96 newly-diagnosed metastatic PDAC patients, showing that patients receiving 2 doses of VCN-01 plus chemotherapy had a median overall survival (OS) of 14.8 months compared to 11.6 months for those receiving chemotherapy alone [2] - In the primary endpoint analysis, patients treated with VCN-01 followed by chemotherapy had a median OS of 10.8 months, while those receiving only chemotherapy had a median OS of 8.6 months [5] - The trial demonstrated increased progression-free survival (PFS) and duration of response (DoR) in the VCN-01 treatment group, with median PFS of 7.0 months compared to 4.6 months for the control group [5] Safety Profile - VCN-01 was well-tolerated, with adverse events being transient and reversible, consistent with prior clinical trials [3][4] - The most common adverse events included pyrexia, flu-like illness, and elevated transaminases, which were less frequent after the second dose of VCN-01 [3] Future Directions - The positive data from the VIRAGE trial is expected to facilitate engagement with industry partners and support the design of a Phase 3 confirmatory trial [3][4]