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Theriva™ Biologics Announces Positive Scientific Advice from the European Medicines Agency (EMA) on the Design of a Phase 3 Trial of VCN-01 in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

- EMA provided overall agreement with the proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC , including sample size, repeated dosing of VCN-01, and an adaptive design to potentially optimize trial timelines and outcomes -

Theriva Biologics Provides Response to Unusual Market Action

ROCKVILLE, Md., Oct. 24, 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, announced today that the Company had become aware of unusual trading activity in its common stock on the NYSE American (the “NYSE”) on October 24, 2025. The Company is issuing this press release pursuant to Section 401(d) of the NYSE Company Guide. The Company has made inquiries and does not believe corrective actions are appropriate. The Company is further announcing that there has been no material development in its business and affairs not previously disclosed or, to its knowledge, any other reason to account for the unusual market action. However, on October 13, 2025, the Company announced the presentation of expanded data from its VIRAGE trial investigating VCN-01 at a mini oral session at the European Society for Medical Oncology (ESMO 2025) Annual Congress.

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

- Released positive topline data from the VIRAGE Phase 2b study of VCN-01 (zabilugene almadenorepvec); expanded data to be presented at the European Society for Medical Oncology (ESMO) 2025 Congress in October -