Wednesday, March 29, 2023
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, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
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FY2022 Reported With Clinical Progress Updates. PDS Biotech reported a 4Q22 loss of $19.1 million or $(0.61) per share and a FY2022 loss of $40.9 million or $(1.43) per share. The loss included $10 million in licensing fees for PDS0301, paid with $5 million in cash and $5 million in stock. Management updated its plans for Phase 3 trials for PDS0101 and PDS0301 during 2023. Cash on hand on December 31, 2022 was $73.8 million, which is expected to fund operations through 3Q24.
PDS Expects To Begin VERSATILE-003 In 4Q23. The Phase 2 VERSATILE-002 trial has reported strong results testing PDS0101 with Keytruda (pembrolizumab, a checkpoint inhibitor) for recurrent or metastatic head and neck cancer. Based on this data, PDS has received FDA guidance for the Phase 3 VERSATILE-003 trial. The trial protocols are being finalized with an IND submission expected in 2H23 and start of enrollment in 4Q23.
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