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PDS Biotech Announces Adoption of Amended Protocol for Phase 3 VERSATILE-003 Trial Incorporating Progression Free Survival (PFS) as Primary Endpoint for Interim Analysis and Potential Accelerated Approval

Enables Potential Shorter Time to Accelerated Approval of PDS0101 in HPV16-positive Head and Neck Cancer Enables Potential Shorter Time to Accelerated Approval of PDS0101 in HPV16-positive Head and Neck Cancer

PDS Biotech Announces Presentation of Preliminary Results from Phase 2 Study of IL-12 Tumor Targeted Immunocytokine (PDS01ADC) in 3rd Line Metastatic Castration Resistant Prostate Cancer by the NCI

NCI-Led Study Shows Median PFS of 9.6 Months  Results Presented at AACR Special Conference on Innovations in Prostate Cancer

PDS Biotech Announces New U.S. Patent Covering Technology Underlying PDS0101

Patent Enhances IP Estate for Lead Asset; Combined with Anticipated Biologics Exclusivity, Market Protections Extend Over 20 Years Patent Enhances IP Estate for Lead Asset; Combined with Anticipated Biologics Exclusivity, Market Protections Extend Over 20 Years

PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint

PDS Biotech Submits Amended Protocol for Phase 3 VERSATILE-003 Trial Constructive Type C Meeting Provides Potential Pathway to Accelerated Approval of PDS0101 PRINCETON, N.J., Jan. 09, 2026 (GLOBE NEWSWIRE) -- 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 that the Company has submitted a protocol amendment to the U.S. Food & Drug Administration (“FDA”) for its Phase 3 VERSATILE-003 clinical trial.