Theriva Biologics (NYSE American: TOVX) is a clinical-stage biotechnology company developing oncolytic virus (OV) therapies for cancer. The company generates no product revenue, funding operations through equity issuances, warrant exercises, and Spanish government research and development tax credits and direct reimbursements. Its lead candidate, VCN-01, is an engineered adenovirus being evaluated in pancreatic ductal adenocarcinoma (PDAC) and retinoblastoma; in the VIRAGE Phase 2b trial, VCN-01 combined with gemcitabine/nab-paclitaxel standard of care produced a median overall survival of 10.8 months versus 8.6 months for standard of care alone (FY2025 10-K, filed 2026-03-12). A second candidate, SYN-004, is in a Phase 1a/2a clinical trial. The company also has VCN-12, the first candidate from its VCN-X discovery program. As of the FY2025 filing, cash was projected sufficient to fund operations only into the first quarter of 2027, and the company requires additional capital to advance beyond current trial phases.

Revenue model

No commercial revenue. Operations are funded through equity offerings, including at-the-market issuances and warrant exercises. The company also participates in a Spanish government R&D reimbursement program; tax credits of $3.4 million (FY2025) and $3.2 million (FY2024) were recognized, with direct reimbursements approved by the Spanish government in September and December 2024.

Products and services

VCN-01: engineered adenovirus-based oncolytic virus in Phase 2b (VIRAGE trial) for PDAC and under investigation for retinoblastoma. SYN-004: in Phase 1a/2a clinical trial, completion of the last cohort requiring significant additional cash. VCN-12: preclinical candidate from the VCN-X discovery program.

Customers and end markets

No commercial customers. End markets are oncology patients, specifically those with pancreatic ductal adenocarcinoma and retinoblastoma. Potential future customers would include hospitals, oncology clinics, and government healthcare programs.

Value-chain role

Clinical-stage drug developer. Conducts preclinical research, clinical trials, and regulatory interactions. Has engaged at least one vendor in China for manufacturing-related activities. Research and development conducted in Spain under the Spanish government reimbursement program.

Geographic exposure

Research and development operations in Spain. Clinical and regulatory activities directed at U.S. (FDA) and international markets. At least one manufacturing vendor located in China.

Competitors

AdCure Bio LLC, Calidi Biotherapeutics Inc., Candel Therapeutics Inc., CG Oncology Inc., Elicera Therapeutics AB, EpicentRx Inc., Replimune Inc., Oncolytics Biotech Inc., Amgen Inc., Daiichi Sankyo Company Ltd., Takara Bio Inc., Hookipa Pharma Inc., Turnstone Biologics Inc., Istari Oncology Inc., Lokon Pharma AB

Source: SEC 10-K, filed 2026-03-12

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