PDS Biotechnology Corporation

PDS Biotechnology Corporation is a clinical-stage biopharmaceutical company dedicated to developing immunotherapies for the treatment of cancer and infectious diseases. The company's mission is to transform how the immune system targets and eliminates these diseases. Headquartered in Princeton, New Jersey, PDS Biotechnology leverages its proprietary Versamune® platform technology to achieve its therapeutic goals.

The company's pipeline is built around its Versamune® platform, which is designed to activate and direct the human immune system against disease. Key product candidates include PDS0101 (also known as Versamune HPV), a lead immunotherapy targeting HPV-associated cancers such as head and neck, cervical, and anal cancers. Additionally, PDS Biotechnology is developing PDS01ADC, an IL-12 fused antibody drug conjugate (immunocytokine) being evaluated in various cancer indications, including metastatic colorectal cancer and prostate cancer. The company is also exploring the application of its Versamune® platform for infectious disease vaccines, including candidates for COVID-19, influenza, and RSV.

Led by President and CEO Dr. Frank Bedu-Addo, PDS Biotechnology has recently achieved significant clinical milestones. The company received FDA alignment on Progression-Free Survival (PFS) as an interim primary endpoint for its Phase 3 VERSATILE-003 trial for PDS0101, which could accelerate the approval pathway for HPV16-positive recurrent/metastatic head and neck cancer. Furthermore, positive interim Phase 2 data for PDS01ADC in metastatic colorectal cancer demonstrated a 77.8% objective response rate and improved 24-month survival. In March 2026, the company reported a net loss of $34.5 million for the full year 2025 and received a Nasdaq notice regarding minimum bid price deficiency. PDS Biotechnology also refinanced debt through a new note and warrant agreement in May 2026.