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NEW YORK - PDS Biotechnology Corporation (NASDAQ:PDSB), a late-stage immunotherapy company, has initiated Phase 3 clinical trials for its Versamune® HPV therapy and reported financial results for the first quarter of 2025. The company, part of EMV Capital plc’s (AIM:EMVC) investment portfolio, focuses on leveraging the immune system to target and eliminate cancers.
During the first quarter, PDS Biotech commenced the VERSATILE-003 Phase 3 trial for its investigational therapy, Versamune® HPV, targeting recurrent/metastatic HPV16-positive head and neck squamous carcinoma (HNSCC). The Mayo Clinic has recently joined as one of the trial sites. The study is designed to enroll approximately 350 patients and will assess overall survival as its primary endpoint.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the combination of Versamune® HPV and pembrolizumab for this HNSCC indication. For more details on the trial, interested parties can refer to ClinicalTrials.gov (Identifier:NCT06790966).
PDS Biotech also announced that three abstracts related to Versamune® HPV will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for May 30-June 3, 2025.
Additionally, the company shared preclinical data on a universal flu vaccine candidate, Infectimune®, at the American Association of Immunologists’ IMMUNOLOGY2025™ Annual Meeting. Moreover, in March, the FDA cleared an Investigational New Drug (IND) application for a combination therapy targeting MUC1-positive unresectable, metastatic colorectal carcinoma, with a Phase 1/2 trial to be led by the National Cancer Institute (NCI).
Financially, PDS Biotech reported a net loss of approximately $8.5 million, or $0.21 per share, for Q1 2025, a decrease from the $10.6 million, or $0.30 per share, reported in the same period the previous year. This decrease was attributed to reduced operating expenses and a greater income tax benefit.
Research and development expenses fell to $5.8 million, down from $6.7 million in Q1 2024, primarily due to lower clinical trial costs. General and administrative expenses also saw a slight decrease.
The company successfully completed a registered direct offering, raising approximately $11 million with the potential for an additional $11 million upon full warrant exercise. PDS Biotech’s cash balance stood at $40 million as of March 31, 2025.
This update is based on a press release statement from PDS Biotech.
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