{"id":958582,"date":"2026-05-05T18:18:28","date_gmt":"2026-05-05T22:18:28","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/theriva-biologics-reports-first-quarter-2026-operational-highlights-and-financial-results\/"},"modified":"2026-05-05T18:18:28","modified_gmt":"2026-05-05T22:18:28","slug":"theriva-biologics-reports-first-quarter-2026-operational-highlights-and-financial-results","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/theriva-biologics-reports-first-quarter-2026-operational-highlights-and-financial-results\/","title":{"rendered":"Theriva\u2122 Biologics Reports First Quarter 2026 Operational Highlights and Financial Results"},"content":{"rendered":"
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\u2013 Alignment with the FDA on the Phase 3 trial design of VCN-01 (zabilugene almadenorepvec) for treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) \u2013<\/p>\n

\u2013 Additional data from VIRAGE Phase 2b clinical trial of VCN-01 in metastatic PDAC patients presented at the recent AACR Annual Meeting may reflect an immune-mediated mechanism of action and demonstrate improved outcomes in VCN-01 treated patients across multiple subgroups, including patients with liver metastases \u2013<\/p>\n

\u2013 VCN-01 administered to retinoblastoma patients under a compassionate use program, which is expected to provide dosing feasibility and tolerability data for a potential Phase 2\/3 clinical trial \u2013<\/p>\n

\u2013 Cash and cash equivalents of $14.4 million as of March 31, 2026; cash runway into Q1 2027 \u2013<\/p>\n

ROCKVILLE, Md., May 05, 2026 (GLOBE NEWSWIRE) — Theriva\u2122 Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.<\/p>\n

\u201cThe first quarter of 2026 was marked by encouraging regulatory progress,\u201d said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. \u201cWe were 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 to evaluate VCN-01 with gemcitabine\/nab-paclitaxel standard-of-care (SoC) chemotherapy in patients with metastatic PDAC. The FDA feedback was consistent with the positive scientific advice previously received from the EMA, with both agencies agreeing to repeated dosing \u2018macrocycles\u2019 of VCN-01 and SoC chemotherapy. Additional data analyses presented in a poster at the AACR Annual Meeting in April 2026 concluded that the additional data may reflect a potential immune-mediated mechanism of action for VCN-01 in metastatic PDAC. We believe that repeated macrocycle dosing of VCN-01 and chemotherapy may enhance this immune action, providing increased and more durable tumor responses and longer survival. As we finalize the pivotal Phase 3 study protocol, we plan 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. This dosing feasibility study is expected to commence at a single site in Spain in the second half of this year. In parallel with our PDAC program, discussions are 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. We believe that intravitreal coadministration of VCN-01 with topotecan may provide a new treatment option for children with refractory retinoblastoma and vitreous seeds, which remains an unmet medical need in patients with this rare disease. In the first quarter of 2026, we made VCN-01 available to investigators for compassionate use in treating patients with retinoblastoma. We expect that outcomes from these compassionate use patients will provide valuable information on the feasibility and tolerability of this combination for use in a potential Phase 2\/3 clinical trial. If a protocol is ultimately submitted to, and agreed by, the FDA, we expect the first patient to be enrolled in December 2026, with rolling Biologic Licensing Application (BLA) submissions expected to be made in 2029 (if successful), targeting potential approval of the BLA prior to September 30, 2029.\u201d<\/p>\n

\n Recent Highlights and Anticipated Milestones<\/strong>\n <\/p>\n

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\n VCN-01<\/u>
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Metastatic PDAC:<\/p>\n