aibioTheriva reports Q1 2026 results and FDA agreement on Phase 3 design
Tickers TOVX
The company reported cash of $14.4 million at March 31, 2026, a runway into Q1 2027, and FDA general agreement on a pivotal Phase 3 design for VCN-01.
Key facts
- Company
- Theriva Biologics, Inc. (AMEX: TOVX)
- News type
- Company Updates
- Primary source
- Theriva Biologics, Inc. 8-K (2026-05-05)
Theriva Biologics, Inc. (NYSE American: TOVX) reported financial results for the first quarter ended March 31, 2026 on May 5, 2026, together with a corporate update. The headline item is regulatory. The company received the minutes of its Type B End-of-Phase 2 meeting with the U.S. Food and Drug Administration, and the FDA gave general agreement to the design of a Phase 3 trial of VCN-01 with standard chemotherapy in metastatic pancreatic ductal adenocarcinoma, or PDAC. The company reported cash and cash equivalents of $14.4 million at March 31, 2026 and said its cash runway extends into Q1 2027.
"The first quarter of 2026 was marked by encouraging regulatory progress," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics, in the quarterly release. He said the company was "pleased to receive the minutes from our end-of-Phase 2 meeting with the FDA and align on the major elements of our proposed pivotal Phase 3 trial."
The regulatory path
The company says the FDA feedback was consistent with earlier scientific advice from the European Medicines Agency, and that both agencies agreed to repeated dosing "macrocycles" of VCN-01 with standard chemotherapy. The FDA gave general agreement to a Phase 3 design that closely tracks the VIRAGE Phase 2 trial, which the company says met its primary endpoints in 2025. In that trial, patients who received VCN-01 with standard chemotherapy had improved overall survival, progression-free survival and duration of response compared with chemotherapy alone, according to the company, which gives no p-values or hazard ratios in the release. Patients who received two doses saw larger gains in overall survival and progression-free survival, which led the company to plan repeat dosing and an adaptive design for the Phase 3 trial.
Retinoblastoma
The company made VCN-01 available to investigators for compassionate use in retinoblastoma. Two patients have been treated with intravitreal VCN-01 combined with intravitreal topotecan, and the treating physicians are following them. The company is in discussions with clinicians and key opinion leaders on a Phase 2/3 protocol for the combination. If the FDA agrees to a protocol, the company expects the first patient to be enrolled in December 2026. Rolling Biologics License Application submissions are expected in 2029, if the program is successful, with a target of approval before September 30, 2029.
First quarter financial results
General and administrative expenses rose to $2.1 million for the three months ended March 31, 2026, from $1.4 million a year earlier. The company says the increase of 43% came mainly from higher legal fees, investor relations costs, registration fees and salary costs.
Research and development expenses fell to $355,000 from approximately $3.0 million, a decrease of 88%. The company attributes the decline mainly to lower clinical trial expenses after the VIRAGE Phase 2b study was completed, the recognition of a Spanish research and development rebate, and lower clinical trial costs for SYN-004. Higher patent expenses related to SYN-020 partly offset those reductions.
Cash and cash equivalents totaled $14.4 million at March 31, 2026, up $1.4 million from December 31, 2025. The release says the primary use of cash was working capital and operating activities. The company reported a net loss of $23.7 million for the year ended December 31, 2025, and a net loss of $2.0 million for the first quarter of 2026.
The risks ahead
The FDA gave only general agreement to the Phase 3 design, and the company has not said how it will pay for the trial. Its own release puts the cash runway into Q1 2027, against $16.7 million of cash used in operations in 2025, and it reported a net loss of $23.7 million for 2025 and $2.0 million for the first quarter of 2026. The company plans a dosing feasibility study at a single site in Spain in the second half of this year, and says research and development expense should fall until it starts more trials. The retinoblastoma protocol still needs FDA agreement, and the filings say a SYN-004 trial depends on funding.