Theriva reports positive Phase 2b pancreatic cancer data, FDA alignment on pivotal trial

Filed May 5, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 14, 2025 · ~1 min read

Key Changes

• high

  VIRAGE Phase 2b trial met primary endpoint: VCN-01 plus chemotherapy extended overall survival to 10.8 months vs 8.6 months for chemo alone (HR=0.57, p=0.0546) in metastatic pancreatic cancer, with doubled duration of response (11.2 vs 5.4 months).

  MD&A: VIRAGE Phase 2b trial results verify on EDGAR →
• high

  FDA provided general agreement in March 2026 on Phase 3 trial design for VCN-01, including acceptance of single pivotal study with repeat dosing, adaptive design, and overall survival as primary endpoint—aligning with prior EMA guidance on path to BLA approval.

  MD&A: FDA End-of-Phase 2 meeting outcomes verify on EDGAR →
• high

  Cash runway extended to Q1 2027 from Q1 2026 as quarterly burn dropped 48% to $2.5M (from $4.8M), driven by 88% reduction in R&D expenses following VIRAGE trial completion. Accumulated deficit now $360.7M, up $21.4M year-over-year.

  Risk Factors: Cash position and runway verify on EDGAR →