Theriva Biologics

TOVX

時価総額 $954万

- Publication in this premier journal after rigorous peer review validates the VIRAGE study and supports the continued evaluation of VCN-01 in the treatment of metastatic pancreatic cancer - - Data are consistent with an immune mediated mechanism of action for VCN-01 that may enhance the antitumor effects of a range of coadministered pancreatic cancer therapies - - The feasibility of administering more frequent repeated VCN-01 doses to potentially improve clinical outcomes in metastatic pancreatic cancer patients is currently being evaluated in the VIRAGE2 Phase 2a clinical trial - ROCKVILLE, Md., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that detailed analysis of results from the VIRAGE Phase 2b clinical trial of VCN-01 (zabilugene almadenorepvec) in metastatic pancreatic cancer patients were published in Nature Medicine.

- VIRAGE2 exploratory study designed to refine the VCN-01 dosing regimen for potential evaluation in a future pivotal Phase 3 clinical trial in metastatic pancreatic ductal adenocarcinoma (PDAC) -

- VIRAGE2 exploratory study designed to refine dosing regimen to potentially improved outcomes in a future pivotal Phase 3 clinical trial - - Study builds on positive clinical data from the recent VIRAGE study and feedback from the EMA and FDA recognizing the potential of repeated VCN-01 dosing to provide clinical benefit - ROCKVILLE, Md., July 07, 2026 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the Company to initiate the VIRAGE2 clinical trial, entitled ”A Phase IIa, single-arm, single-center, open-label, proof-of-concept trial evaluating increased frequency dosing of zabilugene almadenorepvec (VCN-01) in combination with gemcitabine/nab-paclitaxel in patients with newly-diagnosed metastatic pancreatic cancer” (EUCT: 2026-525566-21-00).

– Prolonged overall survival (OS) was observed in heavily pre-treated refractory Head & Neck Squamous Cell Carcinoma (HNSCC) patients administered IV VCN-01 prior to the immune checkpoint inhibitor durvalumab –

– Alignment with the FDA on the Phase 3 trial design of VCN-01 (zabilugene almadenorepvec) for treatment of metastatic pancreatic ductal adenocarcinoma (PDAC) –

The company said new tumor response, biomarker and subgroup analyses from the VIRAGE Phase 2b trial will be presented at the American Association for Cancer Research (AACR) Annual Meeting.

- Tumor reponse, biomarker, and subgroup analyses from the VIRAGE Phase 2b clinical trial support a VCN-01 immune-mediated mode of action and demonstrate improved outcomes in VCN-01 treated patients across multiple subgroups, including patients with liver metastases -

- EMA provided overall agreement with the proposed Phase 3 clinical trial of VCN-01 in combination with gemcitabine/nab-paclitaxel for the first-line treatment of metastatic PDAC , including sample size, repeated dosing of VCN-01, and an adaptive design to potentially optimize trial timelines and outcomes -

ROCKVILLE, Md., Oct. 24, 2025 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, announced today that the Company had become aware of unusual trading activity in its common stock on the NYSE American (the “NYSE”) on October 24, 2025. The Company is issuing this press release pursuant to Section 401(d) of the NYSE Company Guide. The Company has made inquiries and does not believe corrective actions are appropriate. The Company is further announcing that there has been no material development in its business and affairs not previously disclosed or, to its knowledge, any other reason to account for the unusual market action. However, on October 13, 2025, the Company announced the presentation of expanded data from its VIRAGE trial investigating VCN-01 at a mini oral session at the European Society for Medical Oncology (ESMO 2025) Annual Congress.

ROCKVILLE, Md., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced its entry into a warrant inducement agreement with existing institutional investors of the Company for the immediate exercise of warrants to purchase up to 7,360,460 of common stock (the “Existing Warrants”) at a reduced exercise price of $0.54 per share for gross cash proceeds of approximately $4.0 million before deducting fees and other transaction expenses. The offer to exercise will remain open until 11:30 AM ET for up to an additional $0.4 million in gross proceeds. The Company intends to use the net proceeds from the warrant inducement transaction for working capital and other general corporate purposes.