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 business and clinical programs update and reported financial results for the quarter and year ended December 31, 2025.
"The fourth quarter capped a year of important progress for PDS Biotech, marked by meaningful advances across our clinical programs, financial discipline, and intellectual property portfolio," said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech. "Building on the compelling topline data from our VERSATILE-002 Phase 2 trial, we believe the VERSATILE-003 protocol amendment has the potential to create a more efficient path to accelerated approval — shortening the trial's duration, reducing costs, and accelerating our timeline to regulatory submission — while preserving overall survival as the basis for full approval. For patients living with HPV16-positive head and neck cancer, a disease with significant and growing unmet need, we believe PDS0101 represents a promising treatment option, and we remain focused on advancing it as efficiently as possible."
Dr. Bedu-Addo added: "Combined with early data from one of our PDS01ADC Phase 2 programs and expanded patent protections for the Versamune® platform extending into the 2040s, we believe we have meaningful opportunities ahead as we continue to execute against our priorities in 2026."
Clinical and Corporate Update
- Amended the VERSATILE-003 Phase 3 clinical trial protocol to incorporate progression-free survival (PFS) as an interim primary endpoint, creating a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival remains the primary endpoint for full FDA approval. The amendment also reduces the number of enrolled patients while maintaining statistical power. Patients already enrolled prior to the amendment remain on the trial and continue to receive treatment.
- Presented encouraging early results from an NCI-led trial investigating PDS01ADC, the Company's investigational IL-12 tumor-targeted immunocytokine, at the AACR special conference on prostate cancer research. In patients with metastatic castration-resistant prostate cancer (mCRPC) the majority of whom received third-line treatment options — the combination of PDS01ADC and docetaxel demonstrated encouraging median PFS of 9.6 months and a median PSA decline of 40%, with 6 of 16 patients achieving greater than 50% decline.
Strengthened the intellectual property estate for PDS0101 with new patents granted in the U.S. and Japan. The new U.S. patent, combined with anticipated biologics exclusivity, extends market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets.