Theriva Biologics Posts $2M Q1 Loss, $14.4M Cash and FDA Aligns on Phase 3
Theriva Biologics lost $2.0M in Q1 (5 cents per share) on $300k revenue and reduced R&D expenses by 88% to $355k. The company holds $14.4M cash, secured FDA alignment on its pivotal Phase 3 trial for VCN-01 in metastatic PDAC and plans a Phase 3 dosing study in Spain.
1. First Quarter Financial Results
Theriva Biologics reported a net loss of $2.0 million in Q1, or $0.05 per share, on revenues of $300,000. General and administrative expenses rose 43% to $2.1 million, while research and development expenses fell 88% to $355,000 following completion of the VIRAGE Phase 2b trial.
2. Phase 3 Trial Design Alignment
The company received FDA minutes confirming agreement on its proposed pivotal Phase 3 study of VCN-01 combined with gemcitabine/nab-paclitaxel, endorsing repeated macrocycle dosing of the oncolytic vector alongside standard-of-care chemotherapy. This design aligns with previous EMA guidance and the successful VIRAGE trial structure.
3. Clinical Data and Retinoblastoma Program
Additional analyses from the VIRAGE Phase 2b trial presented at the AACR meeting suggested an immune-mediated mechanism, with improved overall survival and progression-free survival in VCN-01-treated metastatic PDAC patients, including those with liver metastases. Separately, VCN-01 has been administered intravitreally with topotecan under compassionate use in retinoblastoma, with two patients treated to date.
4. Cash Position and Runway
As of March 31, Theriva held $14.4 million in cash and equivalents, providing funding into Q1 2027. A small feasibility study of repeated VCN-01 dosing in metastatic PDAC is slated to begin at a single Spanish site in the second half of 2026.