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PRINCETON, N.J. - PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage biotech company with a market capitalization of $54 million, announced Thursday that its PDS0101 therapy combined with Keytruda achieved a median overall survival of 29.5 months in difficult-to-treat head and neck cancer patients with low PD-L1 expression. According to InvestingPro data, the company maintains a healthy liquidity position with a current ratio of 2.92, though analysts note it is currently burning through cash reserves.
The results come from a sub-analysis of the VERSATILE-002 Phase 2 clinical trial involving patients with HPV16-positive recurrent or metastatic head and neck squamous cell cancer. The data specifically focused on patients with low PD-L1 expression (CPS 1-19), a group that historically responds poorly to immune checkpoint inhibitor therapy. InvestingPro analysis reveals that three analysts have recently revised their earnings expectations upward for the upcoming period, suggesting growing confidence in the company’s clinical progress.
According to the company, the 29.5-month survival rate in this patient cohort significantly exceeds published survival rates of 10.8 months with Keytruda monotherapy and 12.3 months with Keytruda plus chemotherapy in similar patients.
"This is great news for these patients who may now have the possibility of a well-tolerated treatment without chemotherapy," said Prof. Kevin Harrington, Head of the Division of Radiotherapy at The Institute of Cancer Research, London, in the press release.
The company noted that approximately 60% of patients enrolled in the trial (53 total participants) had low PD-L1 expression. The sub-analysis focused on 32 patients within this cohort.
Kirk Shepard, Chief Medical Officer of PDS Biotech, stated that the data suggests "the multifunctional T cell immune response of PDS0101 treatment may overcome the documented limitations of immune checkpoint inhibitor therapy" in difficult-to-treat patients.
PDS Biotech previously announced a median overall survival of 39.3 months for the full study population on August 25, with complete trial data expected to be published later this year.
The company is developing PDS0101 (Versamune HPV) as part of its late-stage immunotherapy pipeline focused on how the immune system targets and kills cancers.
The information in this article is based on a press release statement from PDS Biotechnology Corporation.
In other recent news, PDS Biotechnology Corporation 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 surpassing analysts’ forecast of -$0.22. Additionally, PDS Biotechnology announced promising results from its VERSATILE-002 Phase 2 clinical trial for head and neck cancer treatment. The trial showed a median overall survival of 39.3 months in patients treated with its PDS0101 therapy combined with Keytruda. This survival rate significantly exceeds the previously published results for standard care treatments. The trial included 53 patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer. Analyst reactions to these developments have not been explicitly detailed in the provided information.
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