PDS Biotech Updates Business and Reports Q2 2024 Financials

PDS Biotechnology Corporation (Nasdaq: PDSB), an advanced immunotherapy company based in Princeton, N.J., released a business update and its financial results for the second quarter of 2024. The company's CEO, Frank Bedu-Addo, PhD, highlighted the progress made as they aligned with the FDA on the design of the Phase 3 clinical trial of Versamune® HPV in combination with pembrolizumab. This trial aims to compare this combination therapy with pembrolizumab alone for treating first-line recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC).

The CEO emphasized that the Phase 3 trial, named VERSATILE-003, is supported by promising data from the ongoing VERSATILE-002 Phase 2 trial. The company expects to present updated data from this trial at the European Society for Medical Oncology (ESMO) 2024 Congress in September.

Chief Medical Officer Kirk Shepard, M.D., spoke about the revisions made to the statistical endpoints of the VERSATILE-003 trial, which are aimed at strengthening the robustness of the trial design. The company plans to start this trial in the fourth quarter of 2024 and anticipates that future studies involving PDS01ADC could offer additional clinical benefits.

Recent developments include the FDA’s agreement to initiate the Phase 3 VERSATILE-003 trial for HPV16-positive first-line recurrent or metastatic HNSCC. This trial will scrutinize the efficacy of Versamune® HPV combined with pembrolizumab, using updated statistical endpoints based on new survival data from the VERSATILE-002 trial. Preparations for this trial are already underway.

An abstract by Jared Weiss, M.D., of the UNC Lineberger Cancer Center, will present updated data from the VERSATILE-002 trial at the ESMO Congress 2024. This trial evaluates first-line treatment with Versamune® HPV combined with KEYTRUDA® (pembrolizumab) for patients with HPV16-positive recurrent/metastatic HNSCC. The updated survival data from May 17, 2024, show a median overall survival of 30 months, consistent with the data from November 30, 2023.

Further, an abstract by Adam Grippin, M.D., Ph.D., from the University of Texas MD Anderson Cancer Center, will present results from the IMMUNOCERV trial, which evaluates the treatment of high-risk locally advanced cervical cancer with Versamune® HPV in combination with chemoradiotherapy. This will be presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2024. Additionally, Renee Donahue, Ph.D., from the National Cancer Institute, will present preliminary biomarker results from a Phase 2 trial that evaluates the treatment of biochemically recurrent prostate cancer with PDS01ADC combined with enzalutamide. This presentation will take place at the 12th Annual Meeting of the International Cytokine and Interferon Society 2024.

Financial results for the second quarter of 2024 show a net loss of approximately $8.3 million, or $0.23 per share, compared to a net loss of $11.5 million, or $0.37 per share, for the same period in 2023. This reduction in loss is primarily due to decreased operating expenses. Research and development expenses dropped to about $4.5 million from $8.0 million, largely due to lower clinical trial and manufacturing costs. General and administrative expenses also decreased to about $4.2 million from $4.7 million, mainly due to reduced personnel costs and professional fees.

Overall, total operating expenses fell to approximately $8.7 million for the three months ended June 30, 2024, from $12.7 million for the same period in 2023. Net interest expenses, however, increased to about $0.5 million from $0.2 million. As of June 30, 2024, PDS Biotechnology reported cash and cash equivalents totaling about $57.7 million.

PDS Biotechnology specializes in developing immunotherapies that target and eliminate cancer cells and infectious disease vaccines. The company plans to commence a pivotal clinical trial in 2024 for its lead program targeting advanced HPV16-positive head and neck squamous cell cancers.