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PRINCETON, N.J. - PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage biotech company with a market capitalization of approximately $54 million, announced Monday final topline survival data from its VERSATILE-002 Phase 2 clinical trial showing a median overall survival (mOS) of 39.3 months in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer (1L R/M HNSCC) with CPS ≥ 1. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet.
The trial evaluated the combination of PDS0101, the company’s HPV16-targeted immunotherapy, with pembrolizumab (Keytruda) in 53 patients. The lower limit of the 95% confidence interval for survival was 23.9 months, with the upper limit not yet estimable.
According to the company’s press release statement, the current best published survival result with standard of care pembrolizumab or pembrolizumab plus chemotherapy is 17.9 months in this patient population.
Dr. Kirk Shepard, Chief Medical Officer of PDS Biotech, stated that the final data supports "the durable clinical effect of PDS0101," noting similar promising survival outcomes in two other recently published studies.
The treatment regimen consisted of subcutaneous PDS0101 injections administered with intravenous pembrolizumab during the first four treatment cycles, with a fifth and final PDS0101 dose given at cycle 12. Pembrolizumab monotherapy continued on alternating cycles until disease progression, death, or cycle 35.
The company reported that no patients discontinued the trial due to treatment-related adverse events.
PDS Biotech is currently conducting a Phase 3 trial called VERSATILE-003 to further evaluate the treatment combination.
HPV16-positive HNSCC represents a growing segment of head and neck cancers. The company noted that PDS0101 administration is "simple and easy," potentially offering a new treatment option for patients with this form of cancer.
The company plans to publish the complete data set from the trial later this year.
In other recent news, PDS Biotechnology Corp reported its second-quarter earnings for 2025, revealing a narrower-than-expected loss. The company posted an earnings per share (EPS) of -$0.21, slightly beating analysts’ forecasts of -$0.22. This development highlights the company’s ongoing efforts in clinical trials and advancements in its cancer treatment portfolio. The earnings report was a focal point for investors, underscoring the company’s financial performance amid its strategic initiatives. Although the company’s stock price showed a positive premarket reaction, the primary focus remains on the earnings results. These recent developments reflect PDS Biotechnology’s current financial and strategic position as it continues its operations in the biotech sector.
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