From GlobeNewswire: 2025-03-27 07:30:00

PDS Biotechnology has launched the VERSATILE-003 Phase 3 clinical trial to evaluate Versamune® HPV in HPV16-positive head and neck cancer. This trial includes about 350 patients and has Fast Track designation from the FDA. Financially, the company reported a net loss of $37.6 million for the year ended December 31, 2024, with reduced operating expenses.

The VERSATILE-003 trial is designed to target first-line recurrent and/or metastatic HNSCC, with a two-arm controlled trial and a primary endpoint of median overall survival. In March 2025, the first site was activated, aligning with the FDA’s design and clinical endpoints. The Company’s cash balance as of December 31, 2024, was $41.7 million.

In a pivotal clinical trial, PDS Biotechnology is advancing its lead program for advanced HPV16-positive head and neck squamous cell cancers. The company’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with other therapies to enhance patient outcomes. The company’s cash balance was reported at $41.7 million as of December 31, 2024.



Read more at GlobeNewswire:: PDS Biotech Reports Full Year 2024 Financial Results and