PDS Biotechnology (PDSB) – FY2023 Results Included Changes In Development Strategy

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Thursday, March 28, 2024

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

FY2023 Financial Results Included Updated Clinical Trial Strategy. PDS Reported a FY2023 loss of $44.3 million or $(1.43) per share, with cash on December 31, 2023, of $42.9 million. Importantly, the company changed its clinical development plan for PDS1010 and PDS01ADC. The Phase 3 VERSAMUNE-003 will not begin as we expected in 1H24. A Phase 3 trial testing the Triple-Therapy combination will be conducted instead. 

Decision Was Driven By Data From Two Trials. PDS has completed two Phase 2 trials, its VERSATILE-002 trial and the Triple Combination Study conducted by the National Cancer Institute (NCI). VERSATILE-002 trial tested the combination of PDS0101 with Keytruda (pembrolizumab, a PD-1 checkpoint inhibitor), while the Triple Therapy Trial tested PDS0101, a checkpoint inhibitor, and PDS01ADC, a proprietary IL-12-derived molecule.

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