---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-080962"
form_type: "8-K"
ticker: "TOVX"
cik: "0000894158"
company_name: "Theriva Biologics, Inc."
filed_at: "2026-07-07T12:10:51+00:00"
generated_at: "2026-07-07T12:15:15.700563+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Theriva Biologics gets Spanish regulator approval to start VIRAGE2 Phase 2a trial of VCN-01 in pancreatic cancer

## Summary
- AEMPS authorized VIRAGE2, a Phase 2a trial evaluating at least 3 doses of VCN-01 given 2 months apart with gemcitabine/nab-paclitaxel in first-line metastatic PDAC.
- VIRAGE2 builds on VIRAGE Phase 2b (112 patients) where 2 doses of VCN-01 3 months apart significantly improved overall survival, PFS, and duration of response vs. 1 dose or SoC alone.
- EMA and FDA recognized improved survival with 2 doses and suggested more frequent dosing could improve outcomes.
- Results will inform dosing regimen for a potential future pivotal Phase 3 trial.

## SEC filing metadata
- accession: 0001104659-26-080962
- form_type: 8-K
- ticker: TOVX
- cik: 0000894158
- company_name: Theriva Biologics, Inc.
- filed_at: 2026-07-07T12:10:51+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/894158/000110465926080962/0001104659-26-080962-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/894158/000110465926080962/tm2619846d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-080962
- JSON: https://secwatch.observer/filing/0001104659-26-080962.json
- Plain text: https://secwatch.observer/filing/0001104659-26-080962.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.