PDS Biotech reports FY2024 net loss $37.6M; initiates Phase 3 Versamune HPV trial

PDS Biotechnology Corp

Net loss for FY 2024 was $37.6M ($1.03 per share), compared to $42.9M ($1.39 per share) in 2023; operating expenses decreased to $36.3M from $43.0M.
Initiated Phase 3 VERSATILE-003 trial for Versamune HPV in HPV16-positive first-line recurrent/metastatic HNSCC; ~350 patients, primary endpoint overall survival.
FDA cleared IND for combination of Versamune MUC1 and PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma; Phase 1/2 with NCI.
Cash balance as of Dec 31, 2024 was $41.7M; subsequent $22M registered direct offering in Feb 2025 with $11M upfront proceeds.
FDA granted Fast Track designation for Versamune HPV + pembrolizumab combination in recurrent/metastatic HNSCC.

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