VERSATILE-003 Phase 3 Site Initiations Underway Multiple Abstracts Selected for Presentation at the 2025 American Society of Clinical Oncology Annual Meeting Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., May 14, 2025 (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 provided a clinical and corporate update and report ...

Core Insights - PDS Biotechnology Corporation has initiated the VERSATILE-003 Phase 3 clinical trial for its investigational therapy Versamune® HPV targeting recurrent/metastatic HPV16-positive head and neck squamous carcinoma [4][9] - The company reported a net loss of approximately $8.5 million for Q1 2025, a decrease from $10.6 million in Q1 2024, attributed to lower operating expenses and increased tax benefits [6][7] - PDS Biotech's cash balance as of March 31, 2025, was $40 million, down from $41.7 million at the end of 2024 [8][15] Clinical Updates - The VERSATILE-003 trial is designed to include around 350 patients and is a two-arm controlled trial with a 2:1 randomization [6][4] - The primary endpoint of the trial is median overall survival, with interim readouts included in the study design [6][4] - The FDA has granted Fast Track designation for the combination of Versamune® HPV and pembrolizumab in treating recurrent/metastatic HNSCC [6][4] Financial Performance - Research and development expenses for Q1 2025 were $5.8 million, down from $6.7 million in Q1 2024, primarily due to reduced clinical trial expenses [7][6] - General and administrative expenses were slightly lower at $3.3 million for Q1 2025 compared to $3.4 million in Q1 2024 [7][6] - Total operating expenses decreased to $9.1 million in Q1 2025 from approximately $10.1 million in Q1 2024 [8][6] Corporate Developments - Three abstracts on Versamune® HPV were selected for presentation at the 2025 ASCO Annual Meeting scheduled for May 30-June 3, 2025 [6][4] - The company has entered into securities purchase agreements for the sale of 7,330,121 shares of common stock, raising approximately $11 million upon closing [6][4]

Infectimune® studies funded by and performed by investigators at the National Institute of Allergy and Infectious Diseases (NIAID)’s Center for Influenza Vaccine Research for High-Risk Populations (CIVR-HRP)PRINCETON, N.J., May 08, 2025 (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 and infectious diseases, today provided updates on preclinical immune ...

Update on American Association for Cancer Research Annual Meeting 2025 presentation PRINCETON, N.J., April 16, 2025 (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 preclinical immune response data with a novel Infectimune based flu vaccine will be featured in a symposium on universal influenza vaccines at the American Association ...