PDS Biotechnology Files for $200 Million Shelf Offering

PDS Biotechnology Corp. has filed for a mixed shelf of up to $200 million. The clinical-stage immunotherapy company is developing a pipeline of targeted cancer immunotherapies based on its Versamune T cell-activator and Versamune in combination with its interleukin 12 (IL-12) fused antibody drug conjugate, PDS01ADC. Its lead Versamune-based immunotherapy, PDS0101, combines Versamune with a mixture of short proteins derived from the cancer-causing HPV16 viral protein.

PDS Biotechnology Corporation (PDSB) has recently announced the final topline survival data from its VERSATILE-002 Phase 2 clinical trial. The trial evaluated the combination of PDS0101 (Versamune® HPV) and pembrolizumab (Keytruda®) in patients with HPV16-positive recurrent or metastatic head and neck squamous cell cancer (HNSCC).

The median overall survival (mOS) reported in the trial was 39.3 months for patients with a combined positive score (CPS) of ≥ 1. This result significantly outperforms the best available standard of care with pembrolizumab alone, which has a median survival of 17.9 months [1]. The trial also demonstrated durable patient survival promoted by high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101.

Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech, commented on the results, stating that they support the durable clinical effect of PDS0101 and are similarly promising to those reported in other recently published studies, such as the IMMUNOCERV study and the NCI-led study in HPV16-positive recurrent and/or metastatic cancers.

The trial involved 53 patients in the 1L R/M HNSCC arm, with PDS0101 administered by subcutaneous injection together with IV infusion of pembrolizumab during the first 4 treatment cycles. The 5th and final subcutaneous dose of PDS0101 was administered on cycle 12, with pembrolizumab monotherapy administered on subsequent cycles until disease progression, death, or to cycle 35.

The results of the VERSATILE-002 trial are significant for the rapidly growing population of HPV16-positive HNSCC patients, who have a significant and rapidly growing unmet medical need. The combination therapy appears to be well-tolerated, with no patients discontinuing the trial due to treatment-related adverse events.

PDS Biotechnology is now well-positioned to lead in the largest and most rapidly growing segment of HNSCC in the US and Europe. The company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers, and is developing its Versamune-based immunotherapies in combination with standard-of-care immune checkpoint inhibitors and IL-12 fused antibody drug conjugates (ADCs).

In light of these promising results, PDS Biotechnology has filed for a mixed shelf of up to $200 million. The company is focused on transforming how the immune system targets and kills cancers, and its pipeline of targeted cancer immunotherapies holds significant potential for investors and patients alike.

References:
[1] https://www.globenewswire.com/news-release/2025/08/25/3138462/37149/en/PDS-Biotech-Announces-Final-Topline-Survival-Data-from-VERSATILE-002-Phase-2-Trial-in-Head-and-Neck-Cancer.html
[2] https://www.quiverquant.com/news/PDS+Biotechnology+Reports+39.3-Month+Median+Overall+Survival+in+VERSATILE-002+Trial+for+HPV16-Positive+Head+and+Neck+Cancer