ROCKVILLE, Md. — May 5, 2026 — Leads & Copy — Theriva™ Biologics, Inc. (NYSE American: TOVX) announced its first quarter financial results for 2026 and provided a corporate update, highlighting progress with its lead clinical candidate VCN-01 and financial results.
The company reported cash and cash equivalents of $14.4 million as of March 31, 2026, with a cash runway into the first quarter of 2027. General and administrative expenses increased to $2.1 million for the quarter, while research and development expenses decreased to $355,000.
According to Steven A. Shallcross, Chief Executive Officer of Theriva Biologics, the first quarter was marked by regulatory progress. The company received minutes from its end-of-Phase 2 meeting with the FDA and aligned on major elements of its proposed pivotal Phase 3 trial to evaluate VCN-01 with gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC). The FDA feedback was consistent with previous scientific advice received from the EMA, with both agencies agreeing to repeated dosing ‘macrocycles’ of VCN-01 and SoC chemotherapy.
The company plans to generate feasibility data for the intended Phase 3 macrocycle dosing regimen by conducting a small study in metastatic PDAC patients, administering more frequent VCN-01 doses for a longer period at a single site in Spain in the second half of this year.
Additional data analyses presented at the AACR Annual Meeting in April 2026 suggested a potential immune-mediated mechanism of action for VCN-01 in metastatic PDAC, with the company believing that repeated macrocycle dosing of VCN-01 and chemotherapy may enhance this immune action, potentially leading to increased and more durable tumor responses and longer survival.
Discussions are also ongoing with clinicians and key opinion leaders to design a Phase 2/3 clinical trial protocol for the VCN-01 plus topotecan combination in retinoblastoma patients. Theriva Biologics believes that intravitreal coadministration of VCN-01 with topotecan may provide a new treatment option for children with refractory retinoblastoma and vitreous seeds.
In the first quarter, Theriva Biologics made VCN-01 available to investigators for compassionate use in treating patients with retinoblastoma. Outcomes from these patients are expected to provide information on the feasibility and tolerability of this combination for a potential Phase 2/3 clinical trial. If a protocol is submitted to and agreed upon by the FDA, the first patient is expected to be enrolled in December 2026, with rolling Biologic Licensing Application (BLA) submissions expected in 2029, targeting potential approval prior to September 30, 2029.
Financial results indicate that general and administrative expenses increased to $2.1 million for the three months ended March 31, 2026, from $1.4 million for the three months ended March 31, 2025. Research and development expenses decreased to $355,000 for the three months ended March 31, 2026, from approximately $3.0 million for the three months ended March 31, 2025.
Cash and cash equivalents totaled $14.4 million as of March 31, 2026, an increase of $1.4 million from December 31, 2025. The company anticipates research and development expense to decrease in the near future until additional clinical trials commence.
Other income was $83,000 for the three months ended March 31, 2026, compared to $93,000 for the three months ended March 31, 2025.
Tumor response, biomarker, and subgroup analyses from the VIRAGE Phase 2b clinical trial were presented at the American Association for Cancer Research (AACR) 2026 annual meeting. The poster concluded that the additional data may reflect an immune-mediated mechanism of action for VCN-01, with improved overall survival in VCN-01-treated patients across multiple subgroups, including patients with liver metastases.
Two patients have been treated with intravitreal VCN-01 in combination with intravitreal topotecan and are being followed by the treating physicians.
Net loss attributable to common stockholders was $(2,044) thousand, or $(0.05) per share, for the three months ended March 31, 2026, compared to $(4,324) thousand, or $(1.55) per share, for the three months ended March 31, 2025.
Theriva Biologics is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need.
Source: Theriva™ Biologics
