Theriva Biologics, Inc.

Theriva Biologics announced the publication of clinical and translational results from its Phase I clinical trial of VCN-01 in head and neck squamous cell carcinoma (HNSCC) in Clinical Cancer Research. The study demonstrated prolonged overall survival in heavily pre-treated HNSCC patients receiving VCN-01 intravenously before durvalumab. Pharmacokinetic, biopsy, radiomic, and transcriptomic data supported VCN-01's proposed mechanisms of stromal degradation and immune potentiation, suggesting resensitization of refractory tumors to durvalumab.

Theriva Biologics announced that clinical and translational results from its VCN-01 Phase 1 clinical trial in Head & Neck Squamous Cell Carcinoma (HNSCC) were published in Clinical Cancer Research. The trial in 20 refractory HNSCC patients showed median overall survival ranging from 10.3 to 17.3 months across different treatment arms. Biomarker analysis indicated VCN-01's potential to degrade tumor stroma and enhance anti-tumor immune responses, supporting its combination with durvalumab.

Theriva Biologics announced the publication of clinical and translational results from VCN-01's Phase 1 clinical trial in Head & Neck Squamous Cell Carcinoma (HNSCC) in Clinical Cancer Research. The trial demonstrated prolonged overall survival in heavily pre-treated refractory HNSCC patients administered IV VCN-01 prior to durvalumab. Results support VCN-01's stroma-degrading and immune-enhancing modes-of-action, resensitizing tumors to durvalumab and reactivating immune responses.

Theriva Biologics, Inc. announced that its Special Meeting of Stockholders, called for June 5, 2026, could not convene due to a lack of quorum. The meeting's primary purpose was to seek stockholder approval for the issuance of up to 16,184,560 shares of common stock upon the exercise of certain warrants, as stipulated by an Inducement Agreement from October 16, 2025. As a result, the company is now obligated to call additional stockholder meetings every 60 days until the necessary approval is secured or the warrants are no longer outstanding, unless waived by the investors.

Theriva Biologics announced FDA agreement on the Phase 3 trial design for VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC), aligning with EMA's scientific opinion. Additional Phase 2b data for VCN-01 in PDAC showed improved patient outcomes and a potential immune-mediated mechanism. The company also reported Q1 2026 financial results, including a reduced net loss of $2.0 million and $14.4 million in cash, providing liquidity until Q1 2027. Discussions are ongoing for a Phase 2/3 trial of VCN-01 for retinoblastoma, with compassionate use data expected.

Theriva Biologics entered a license agreement with Rasayana Therapeutics for SYN-020, receiving an upfront payment of $300,000 and potential future milestone payments. The company reported a net loss of $2.044 million for Q1 2026, a significant reduction from $4.324 million in Q1 2025. Cash and cash equivalents increased to $14.431 million, partly due to $2.303 million from an "at-the-market" offering. Despite these positive developments, the company continues to face going concern uncertainties and is actively seeking additional financing to fund its clinical trials and operations into Q1 2027.

Theriva Biologics reported its first-quarter 2026 financial results, showing a reduced net loss of $(2.04) million and a cash position of $14.4 million, providing a runway into Q1 2027. The company also announced significant operational progress, including alignment with the FDA on the Phase 3 trial design for VCN-01 in metastatic PDAC and the initiation of compassionate use for VCN-01 in retinoblastoma patients. R&D expenses decreased significantly due to the completion of the VIRAGE Phase 2b trial, while G&A expenses increased.

Theriva Biologics reported Q1 2026 financial results and provided a corporate update, highlighting significant progress in its clinical programs. The company aligned with the FDA on the Phase 3 trial design for VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC) and initiated a compassionate use program for VCN-01 in retinoblastoma. As of March 31, 2026, Theriva Biologics had $14.4 million in cash and cash equivalents, providing a runway into Q1 2027, while reporting a net loss of $2.0 million for the quarter.

Theriva Biologics, Inc. will hold a Special Meeting on June 5, 2026, to seek stockholder approval for the issuance of up to 16,184,560 shares of common stock upon the exercise of warrants issued in an October 2025 private placement. This approval is required by NYSE American rules and is crucial for the company to receive up to $8.7 million in gross proceeds from warrant exercises. The meeting will also address an adjournment proposal if insufficient votes are received, following three previous attempts that failed due to lack of quorum.

Theriva Biologics, Inc. announced an upcoming poster presentation of new data and subgroup analyses from its VIRAGE Phase 2b clinical trial. The trial evaluates VCN-01 (zabilugene almadenorepvec) in combination with gemcitabine/nab-paclitaxel for newly-diagnosed metastatic pancreatic cancer patients. The presentation will take place at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA, on April 20, 2026.