aibioTheriva Biologics doses first VIRAGE2 patients and reports cash into Q1 2027
Tickers TOVX
The NYSE American company reported $11.3 million of cash at June 30, 2026, after first patients were dosed in a Phase 2a trial of more frequent VCN-01 dosing in pancreatic cancer.
Key facts
- Company
- Theriva Biologics, Inc. (AMEX: TOVX)
- News type
- Company Updates
- Primary source
- Theriva Biologics, Inc. 8-K (2026-08-11)
Theriva Biologics, Inc. (NYSE American: TOVX) reported second quarter 2026 results on August 11, 2026, and said the first patients have been dosed in its VIRAGE2 Phase 2a clinical study. The study tests more frequent repeated dosing of VCN-01 (zabilugene almadenorepvec) in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma. The company reported cash and cash equivalents of $11.3 million as of June 30, 2026, and said its cash runway extends into Q1 2027.
The VIRAGE2 trial
VIRAGE2 is a single-arm, single-center, open-label proof-of-concept trial. It combines VCN-01 with gemcitabine and nab-paclitaxel in patients with newly diagnosed metastatic pancreatic cancer. The study will evaluate the safety and feasibility of giving at least 3 doses of VCN-01, about 2 months apart, with standard chemotherapy. The trial is expected to enroll 6 evaluable patients, and enrollment is expected to complete during the second half of 2026. Initial pharmacodynamic and safety and tolerability data are expected by Q3 2027.
The study design incorporates feedback from the European Medicines Agency and the U.S. Food and Drug Administration, which recognized improved survival outcomes in the VIRAGE Phase 2b trial of two doses of VCN-01 with standard chemotherapy. Results will inform dosing for a possible future pivotal Phase 3 trial.
Other programs
For retinoblastoma, the company completed the design of a proposed Phase 2/3 trial of intravitreal VCN-01 combined with intravitreal topotecan. The trial would enroll children with vitreous seeds that are refractory or resistant to current intravitreal chemotherapy. The company plans to discuss the protocol with the FDA in Q3 2026. VCN-01 holds Orphan Drug Designation from both the FDA and the EMA, and Rare Pediatric Disease Designation from the FDA for retinoblastoma. If the FDA approves a Biologics License Application for VCN-01 in retinoblastoma by September 30, 2029, the company may be eligible for a Priority Review Voucher.
In head and neck squamous cell carcinoma, clinical and translational results from a Phase 1 trial were published in Clinical Cancer Research. In that trial, heavily pretreated patients who received intravenous VCN-01 before the immune checkpoint inhibitor durvalumab had prolonged overall survival. The company says pharmacokinetic, tissue biopsy, radiomic and transcriptomic results support the proposed stroma-degrading and immune-enhancing actions of VCN-01.
In February 2026 it granted Rasayana Therapeutics, Inc. an exclusive worldwide license to SYN-020, with Rasayana assuming responsibility and costs for development and commercialization. Enrollment in the exploratory SYN-004 (ribaxamase) trial is paused.
Quarterly results and cash
General and administrative expenses fell to $2.0 million in the quarter ended June 30, 2026, from $11.2 million a year earlier. The company attributes the decrease mainly to a $9.2 million fair value increase in contingent consideration in the prior-year quarter, partly offset by higher legal fees this year. Research and development expenses decreased to $1.3 million from $2.0 million, mainly because of lower indirect compensation costs and lower clinical trial expenses for SYN-004 and SYN-020.
Cash and cash equivalents totaled $11.3 million as of June 30, 2026, a decrease of $1.7 million from December 31, 2025. The company reported a net loss of $23.7 million for 2025 and $5.3 million for the six months ended June 30, 2026. Its annual report shows research and development expense of $8.6 million for 2025, compared with $12.0 million for 2024, and cash from operations of negative $16.7 million in 2025 and negative $16.9 million in 2024.
What the trial can and cannot show
VIRAGE2 is a six-patient, single-arm, open-label study, so it cannot show efficacy against chemotherapy alone; it is built to test safety, feasibility and pharmacodynamics. The company's own timetable puts initial data in Q3 2027, after the cash runway it states, which extends only into Q1 2027, so more money has to be found before the data arrive. The release gives no survival figures for the VIRAGE Phase 2b trial. The head and neck result comes from a Phase 1 trial. The company plans to discuss the retinoblastoma protocol with the FDA in Q3 2026, and a pivotal Phase 3 in pancreatic cancer remains only a possibility.