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PRINCETON, N.J. - PDS Biotechnology Corporation (NASDAQ:PDSB), a late-stage immunotherapy company with a market capitalization of $71.5 million, has announced new data from its Versamune® HPV studies, revealing prolonged survival times in patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting scheduled for May 30-June 3, 2025, in Chicago, Illinois. According to InvestingPro data, the company’s stock has shown strong momentum with a 17% return over the past week, despite broader market challenges.
The Phase 2 trial, known as VERSATILE-002, reported a median overall survival (mOS) of 39.3 months for patients with a Combined Positive Score (CPS) of 20 or higher, exceeding the previously published mOS for pembrolizumab alone, which is approximately 15 months. For patients with a CPS of 1 or greater, the mOS was 30.0 months, compared to pembrolizumab’s 12 months. These results indicate a significant improvement in survival outcomes for patients treated with the combination of PDS Biotech’s immunotherapy and pembrolizumab. Notably, InvestingPro analysis shows that two analysts have recently revised their earnings expectations upward for the upcoming period, with analyst price targets ranging from $4.50 to $13.00 per share.
The ongoing Phase 3 trial, VERSATILE-003, is currently enrolling patients to further evaluate the efficacy of the combination treatment against pembrolizumab alone. The primary endpoint of the study is median overall survival, with two interim analyses planned. This trial aims to accrue 351 patients who will be randomized in a 2:1 ratio.
Additionally, a Phase 2 "window of opportunity" trial, MC200710, investigated the therapeutic vaccine PDS0101, both alone and in combination with pembrolizumab, prior to surgery or radiation therapy for locally advanced HPV-associated oropharyngeal carcinoma. The study observed clinical activity with just two cycles of treatment and achieved the primary endpoint of a 50% reduction in circulating tumor DNA (ctDNA) response.
PDS Biotech’s Chief Medical Officer, Dr. Kirk Shepard, expressed confidence in the strength and durability of the data, which shows the longest survival reported to date in first-line recurrent/metastatic head and neck cancer. The company estimates that HPV16-positive patients make up 40-60% of the ICI-naïve r/m HNSCC population in the U.S.
A conference call to discuss the ASCO abstract data sets is scheduled for Friday, May 23 at 8:00 a.m. ET. The information in this article is based on a press release statement from PDS Biotechnology Corporation. While the company shows promising clinical results, InvestingPro data indicates it is currently burning through cash with negative free cash flow of $35 million in the last twelve months. For deeper insights into PDS Biotechnology’s financial health and growth prospects, including 8 additional ProTips and comprehensive valuation metrics, investors can access the full Pro Research Report available on InvestingPro.
In other recent news, PDS Biotechnology Corp reported a decrease in its net loss for the first quarter of 2025, with losses narrowing to $8.5 million, or $0.21 per share, compared to $10.6 million, or $0.30 per share, in the same period last year. The company has not specified its revenue figures but highlighted a reduction in research and development expenses to $5.8 million from $6.7 million. PDS Biotech is advancing its clinical trials, including a Phase III trial for its HPV16-targeted cancer therapy, which has gained attention due to the potential of its Versamune HPV and pembrolizumab combination. The company’s cash balance stood at $40 million as of March 31, 2025. Analysts from firms like B. Riley Securities have shown interest in the company’s strategic developments, particularly the progression of their VERSAL-three trial. Additionally, PDS Biotech has been involved in collaborations with institutions like the National Cancer Institute and Mayo Clinic, furthering its research in cancer therapies. These developments indicate a continued focus on innovative treatments and strategic partnerships.
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