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NEW YORK - PDS Biotechnology Corporation (NASDAQ:PDSB), a late-stage immunotherapy company, has initiated a Phase 3 clinical trial for its Versamune® HPV immunotherapy in patients with HPV16-positive head and neck cancer. The company, part of EMV Capital plc’s (AIM: EMVC) portfolio, reported this development alongside its full-year 2024 financial results.
The VERSATILE-003 trial, which started in March 2025, is designed to enroll approximately 350 patients with recurrent/metastatic HPV16-positive head and neck squamous carcinoma (HNSCC). The trial follows positive outcomes from the VERSATILE-002 study and has received Fast Track designation from the U.S. Food and Drug Administration (FDA). The FDA has aligned with PDS Biotech on the trial’s design and endpoints, which include median overall survival as the primary endpoint.
In addition to the VERSATILE-003 trial, PDS Biotech announced in March 2025 the FDA clearance of an Investigational New Drug (IND) application for a combination therapy targeting MUC1-positive unresectable, metastatic colorectal carcinoma. This Phase 1/2 clinical trial will be conducted under a Cooperative Research and Development Agreement with the National Cancer Institute.
PDS Biotech also presented updated results from the IMMUNOCERV Phase 2 clinical trial in locally advanced cervical cancer patients at the 66th American Society for Radiation Oncology (ASTRO) Annual Meeting in October 2024. Furthermore, the design of a recurrent prostate cancer trial was presented at the 12th Annual Meeting of the International Cytokine and Interferon Society (Cytokines 2024).
Financially, PDS Biotech reported a net loss of approximately $37.6 million for the year ended December 31, 2024, a reduction from the $42.9 million net loss in the previous year. The decrease in net loss was mainly due to lower operating expenses, which totaled $36.3 million for 2024 compared to $43.0 million for 2023. Research and development expenses decreased by $5.2 million, while general and administrative expenses saw a $1.5 million reduction. Net interest expense, however, increased to $2.2 million for the year.
On February 27, 2025, PDS Biotech announced a registered direct offering potentially worth up to $22 million, with $11 million in upfront gross proceeds and an additional $11 million upon full exercise of warrants issued to investors. As of December 31, 2024, the company’s cash balance stood at $41.7 million.
The information in this article is based on a press release statement from PDS Biotech.
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