Theriva Biologics (TOVX) Company Report

Theriva Biologics, Inc. announced positive results from its Phase 2b VIRAGE clinical trial for VCN-01 in patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC), demonstrating increased overall survival, progression-free survival, and duration of response compared to standard of care alone, with greater improvements observed with two doses of VCN-01.
The company is actively pursuing regulatory agreement for a Phase 3 trial design for VCN-01 in PDAC, having received positive Scientific Advice from the European Medicines Agency (EMA) and anticipating an End-of-Phase 2 Meeting with the FDA in Q1 2026.
Additional clinical activities for VCN-01 include planning a potential pivotal trial in retinoblastoma and a Phase 1b study in PDAC to explore more frequent dosing.
Key projected milestones for 2026 include an FDA End-of-Phase 2 meeting for VCN-01 in PDAC in Q1, an FDA meeting for VCN-01 in retinoblastoma in Q3, and the potential initiation of the VCN-01 PDAC Phase 3 trial in Q4, contingent on funding.

Jan 12, 2026, 2:11 PM

Theriva Biologics Reports Q3 2025 Financial Results and Clinical Progress

TOVX

Earnings

Guidance Update

New Projects/Investments

Theriva Biologics reported cash and cash equivalents of $7.5 million as of September 30, 2025, which increased to $15.5 million by November 10, 2025, extending its cash runway into Q1 2027.
The company is pursuing regulatory discussions with the European Medicines Agency and US FDA for a proposed Phase 3 study of VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC) and is designing a potential Phase 2/3 clinical trial in retinoblastoma for discussion in the first half of 2026.
For the third quarter ended September 30, 2025, Theriva Biologics reported a net loss of $(4.361) million and net loss per share of $(0.45).
General and administrative expenses decreased to $1.9 million and research and development expenses decreased to $2.6 million for the three months ended September 30, 2025, compared to the same period in 2024.

Nov 12, 2025, 1:10 PM

Theriva Biologics presents positive Phase 2b VIRAGE trial data for mPDAC

TOVX

Product Launch

New Projects/Investments

Theriva Biologics, Inc. (TOVX) presented expanded data from its VIRAGE Phase 2b trial for metastatic pancreatic ductal adenocarcinoma (mPDAC) at the European Society for Medical Oncology (ESMO 2025) Annual Congress on October 20, 2025.
The trial's primary endpoint, Overall Survival (OS), was met, with patients receiving VCN-01 + standard of care (SoC) demonstrating a median OS of 10.8 months compared to 8.6 months for SoC alone (HR 0.57, p-value 0.034).
Progression-Free Survival (PFS) was also significantly improved in the VCN-01 + SoC arm, with a median of 7.0 months versus 4.6 months for SoC alone (HR 0.55, p-value 0.012).
The combination of VCN-01 with gemcitabine/nab-paclitaxel was found to be safe and well tolerated.

Oct 20, 2025, 11:22 AM

Theriva Biologics Completes Warrant Inducement Transaction

TOVX

Theriva Biologics completed a warrant inducement transaction on October 17, 2025, generating approximately $4.4 million in gross proceeds.
The transaction involved existing institutional investors exercising warrants to purchase 8,092,280 shares of common stock at a reduced exercise price of $0.54 per share.
In consideration for the exercise of these existing warrants, the company issued new unregistered warrants to purchase 16,184,560 shares of common stock.
The new warrants are exercisable at $0.54 per share and will expire five years following stockholder approval.
The net proceeds from this transaction are intended for working capital and other general corporate purposes.

Oct 17, 2025, 9:19 PM

Theriva Biologics Announces Positive Phase 2b Trial Results for VCN-01 and Upcoming Presentations

TOVX

New Projects/Investments

Theriva Biologics (TOVX) announced upcoming presentations at medical meetings for its drug candidates, VCN-01 and SYN-004, on October 20, 2025.
Expanded data from the VIRAGE Phase 2b trial for VCN-01 in metastatic pancreatic cancer (mPDAC) will be presented at ESMO 2025.
The VIRAGE Phase 2b trial met its primary endpoints, demonstrating improved Overall Survival (OS), Progression-Free Survival (PFS), and Duration of Response (DoR) for patients receiving VCN-01 plus standard of care chemotherapy.
In the full analysis set (FAS) population, OS was 10.8 months for the VCN-01 + GA arm versus 8.6 months for the GA-only arm, and PFS was 7.0 months versus 4.6 months, respectively.