Initiation of VERSATILE 003 Phase 3 Trial
PDS Biotech initiated the VERSATILE 003 Phase 3 clinical trial for Versamune HPV plus pembrolizumab, targeting HPV16-positive head and neck cancer. The trial design has been approved by the FDA and includes 350 patients.
Positive Phase 2 VERSATILE 002 Results
The VERSATILE 002 trial showed encouraging patient survival and clinical responses, with a median overall survival of 30 months compared to the standard 12 months for HPV16-positive head and neck cancer.
FDA IND Clearance for New Drug
FDA cleared the investigational new drug application for Versamune MUC1 and IL-12 fused antibody drug conjugate PDS01ADC for metastatic colorectal cancer.
Strong Financial Position
Reported a net loss of $8.5 million, an improvement from the previous year's $10.6 million. Cash balance stood at $40 million as of March 31, 2025.