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Theriva Biologics, Inc. develops therapeutics for cancer and related diseases as a diversified clinical-stage biotechnology company. Its subsidiary, Theriva Biologics, S.L., is developing an oncolytic adenovirus platform for intravenous, intravitreal and antitumoral delivery. The company’s lead candidate, VCN-01, is designed to replicate selectively within tumor cells and degrade the tumor stroma barrier associated with cancer treatment resistance.
Recurring Theriva Biologics news includes VCN-01 clinical data in metastatic pancreatic ductal adenocarcinoma and retinoblastoma, regulatory interactions with U.S. and European agencies, medical-conference presentations, and operational financial results. Coverage also includes SYN-004, or ribaxamase, for gastrointestinal degradation of certain IV beta-lactam antibiotics, and the licensed SYN-020 recombinant intestinal alkaline phosphatase program.
Theriva Biologics (NYSE:TOVX) received Scientific Advice from the EMA CHMP on a proposed double-blind, randomized, placebo-controlled Phase 3 trial of VCN-01 plus gemcitabine/nab-paclitaxel for first-line metastatic pancreatic ductal adenocarcinoma (PDAC).
CHMP agreed on overall survival as primary endpoint, key secondary endpoints, inclusion/exclusion criteria, sample size, and an adaptive design. CHMP supported repeated “macrocycle” dosing (more than two doses) after positive VIRAGE Phase 2b signals. Theriva plans an FDA End-of-Phase 2 meeting in H1 2026. Cash of $15.5M provides runway into Q1 2027 to complete regulatory and partnering activities.
Theriva Biologics (NYSE: TOVX) reported Q3 2025 operational and financial results with key clinical updates and cash guidance. Expanded VIRAGE Phase 2b data for VCN-01 in metastatic PDAC showed the study met primary endpoints with improved OS, PFS and DoR, measurable viral genomes for ≥3 months, and greater benefit with two doses.
Preclinical data for next‑gen VCN-12 showed higher tumor killing and hyaluronidase activity versus VCN-01. Cash was $7.5M at Sept 30, 2025 and increased to $15.5M by Nov 10, 2025, funding operations into Q1 2027.
Theriva Biologics (NYSE American: TOVX) announced awareness of unusual trading activity in its common stock on the NYSE American on October 24, 2025. The company said it has made inquiries, does not believe corrective actions are appropriate, and is not aware of any material development in its business or affairs that would explain the trading.
The company noted a prior announcement on October 13, 2025 about presenting expanded data from the VIRAGE trial of VCN-01 at a mini oral session during ESMO 2025.
Theriva Biologics (NYSE American: TOVX) entered a warrant inducement agreement to accelerate the exercise of existing warrants for up to 7,360,460 shares at a reduced price of $0.54 per share, generating approximately $4.0 million in gross proceeds, with an offer window to raise up to an additional $0.4 million. In return, investors will receive new unregistered warrants to purchase up to 14,720,920 shares at $0.54, exercisable after stockholder approval and expiring five years after the Approval Date. Closing is expected on or about October 17, 2025. Net proceeds are intended for working capital and general corporate purposes. A.G.P./Alliance Global Partners acted as exclusive financial advisor.
Theriva Biologics (NYSE American: TOVX) announced two upcoming medical meeting presentations on October 20, 2025. VCN-01 expanded data from the VIRAGE Phase 2b trial in metastatic pancreatic cancer (mPDAC) will be presented as a mini-oral at ESMO 2025 by Dr. Rocío Garcia-Carbonero (Abstract #2216MO) at 09:28 a.m. CEST in Bonn Auditorium, Messe Berlin.
SYN-004 blinded safety and PK data from the Phase 1b/2a randomized, double-blinded, placebo-controlled trial in allogeneic HCT recipients will be presented as a poster at IDWeek 2025 by Dr. Erik R. Dubberke (Abstract #P-104) on October 20, 2025 from 12:15–1:30 p.m. EDT in Poster Hall B4-5, Georgia World Congress Center, Atlanta.
Theriva Biologics (NYSE American: TOVX) will present preclinical data for VCN-12, a next‑generation oncolytic adenovirus from the VCN‑X discovery program, at the 32nd Annual ESGCT meeting in Seville on Oct 8, 2025 at 08:30 CEST.
Presenter Dr. Ramón Alemany will describe mechanistic data showing VCN‑12 is derived from clinical lead VCN‑01 and is armed with additional transgenes intended to improve tumor cell lysis, stroma degradation, and antitumor immunity. A pre‑ESGCT monograph also reports preclinical intracranial administration data for VCN‑01 supporting further development for brain tumors.
Theriva Biologics (NYSE American: TOVX) reported significant progress in Q2 2025, highlighted by positive topline results from their VIRAGE Phase 2b trial of VCN-01 (zabilugene almadenorepvec) in metastatic pancreatic cancer. The drug, combined with standard chemotherapy, demonstrated improved overall survival, progression-free survival, and duration of response.
The company also presented Phase 1 safety and clinical outcome data for VCN-01 in retinoblastoma at ASCO 2025. Financially, Theriva reported $12.1 million in cash as of June 30, 2025, with runway extending into Q1 2026. General and administrative expenses increased significantly to $11.2 million, while R&D expenses decreased 34% to $2.0 million.
Theriva Biologics (NYSE American: TOVX) has completed its previously announced public offering, raising $7.5 million in gross proceeds. The offering consisted of 6,818,180 shares of common stock (or pre-funded warrants) and warrants to purchase an equal number of shares at a combined price of $1.10 per share and accompanying warrant.
The warrants are immediately exercisable at $1.10 per share and will expire in five years. The company plans to use the proceeds for working capital, general corporate purposes, research and development, and manufacturing scale-up. A.G.P./Alliance Global Partners served as the sole placement agent for the offering.