Core Viewpoint - PDS Biotechnology Corporation is seeking an accelerated approval pathway for its investigational treatment PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer, following positive results from the VERSATILE-002 trial [2][3] Group 1: FDA Meeting and Approval Pathway - The FDA has accepted PDS Biotechnology's request for a Type C Meeting to discuss the proposed accelerated approval pathway for PDS0101 [1] - The proposed amendment to the VERSATILE-003 Phase 3 trial aims to change the progression-free survival (PFS) endpoint to a surrogate primary endpoint, allowing for earlier evaluation with significant statistical power [2] - Median overall survival (mOS) will remain the primary endpoint for full approval as originally recommended by the FDA [2] Group 2: Clinical Trial Insights - The VERSATILE-002 trial demonstrated promising median overall survival and durable progression-free survival in patients with CPS ≥ 1 [2] - The company believes that the positive PFS data from VERSATILE-002 presents an opportunity to shorten the duration to a primary endpoint and potentially accelerate regulatory submission [3] Group 3: Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune system responses to cancer [4] - The lead investigational treatment, PDS0101 (Versamune HPV), is being developed in combination with a standard-of-care immune checkpoint inhibitor and in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate [4]

Core Insights - PDS Biotechnology Corporation is a late-stage immunotherapy company focused on enhancing the immune system's ability to target and eliminate cancers [3] - The company will participate in the 27th Annual H.C. Wainwright Global Investment Conference from September 8-10, 2025, in New York and virtually, with key executives available for one-on-one meetings with investors [1][2] Company Overview - PDS Biotechnology is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers through a pivotal clinical trial [3] - The lead investigational targeted immunotherapy, PDS0101 (Versamune HPV), is being developed in combination with the immune checkpoint inhibitor pembrolizumab [3] Investor Relations - Investors interested in engaging with the management team are encouraged to contact their H.C. Wainwright representative [2]