PDS Biotechnology Adopts Amended Protocol To Its Phase 3 VERSATILE-003 Clinical Study

PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes PFS as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival (mOS) remains the trial's primary endpoint for full approval, consistent with the Company's prior regulatory dialogue and post-meeting communication following its Type C meeting with the U.S. Food and Drug Administration ("FDA"). Following the FDA's standard 30-day wait period since filing of the amended protocol to the Investigational New Drug (IND) Application, without objection, the Company is proceeding with the amended protocol.