Theriva Biologics Inc (TOVX)

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NEWS -- Theriva™ Biologics Reports Second Quarter 2023 Operational Highlights and Financial Results

• Initiated dosing at U.S. sites for VIRAGE, the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for Pancreatic Ductal Adenocarcinoma
• Second doses of intravenous VCN-01 administered to patients in Spain and were well tolerated with a safety profile consistent with prior clinical trials
• VIRAGE remains on track to complete enrollment in the first quarter of 2024
• VCN-01 granted Orphan Drug Designation by the U.S. FDA for the treatment of pancreatic cancer
• Ramon Alemany, Ph.D., appointed as Senior Vice President of Discovery, strengthening the collaboration with the Institut Catala d’Oncologia (ICO) and the Biomedical Research Institute of Bellvitge (IDIBELL)
• As of June 30, 2023, Theriva Biologics reports $34.2 million in cash, which is expected to provide runway into the fourth quarter of 2024
• Conference call and webcast to be held on Tuesday, August 8th at 8:30 a.m. ET

ROCKVILLE, Md., Aug. 08, 2023 (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 reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.

“We are pleased by the continued progress in the first half of 2023 and look forward to executing on key priorities for our a systemically administered oncolytic adenovirus and lead program, VCN-01, in key indications and therapeutic combinations,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “Notably, we have initiated dosing at U.S. sites for VIRAGE, the Phase 2b trial of VCN-01 in patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). Dosing in Spain initiated in January 2023 and the first patients have now received their second doses of intravenous VCN-01, which were well tolerated with safety profile consistent with prior clinical trials. VIRAGE remains on track to complete enrollment in the first quarter of 2024. Reaching this critical milestone adds to the strong momentum for the trial and we are further encouraged by the FDA’s decision to grant orphan drug designation to VCN-01 for patients with pancreatic cancer, for which there is an urgent need for new treatment options.”

Mr. Shallcross continued, “We are encouraged by the growing clinical data that underscores VCN-01’s multi-modal mechanism of action, alone or in combination with chemotherapy and immunotherapy products. At the upcoming annual ESMO Congress in Madrid, investigators will present survival data from the ongoing study of VCN-01 in combination with durvalumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck, which will provide the first clinical insights into the feasibility of combining VCN-01 with an immune checkpoint inhibitor. These results build on the impressive safety, biochemical and mechanistic data presented last year, demonstrating that VCN-01 improved tumor immunogenicity in previously immunotherapy refractory patients. In parallel, we look forward to upcoming discussions with regulatory agencies planned in the second half of 2023 to discuss the development pathway for VCN-01 as an adjunct to chemotherapy in pediatric patients with advanced retinoblastoma. Further, as we continue to explore the potentially broad synergistic clinical benefit of VCN-01, we remain committed to pursuing new oncolytic virus candidates to leverage our novel Albumin Shield technology, which has tremendous potential for our pipeline.”

For full Press Release including Financial Charts, go to the link below:

https://finance.yahoo.com/news/theriva-biologics-reports-second-quarter-120000783.html