PDS Biotechnology Corp. (PDSB) – Answering Questions About The VERSATILE-002 Data


Friday, June 16, 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, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

The Phase 2 VERSATILE-002 Trial Remains Misunderstood. We have received inquiries from investors about the data in the recent ASCO presentation by PDS Biotech. We believe there is some misunderstanding of the trial design, outcome data, and the trial’s definition of efficacy. In view of the fundamental progress and stock price decline, we believe this is a buying opportunity.

Trial Data Has Led To Misinterpretation. The Phase 2 VERSATILE-002 trial has a primary endpoint of best overall response rate (ORR). To be considered a responder, patients need to have tumor shrinkage of at least 30% in two MRI scans. Patients with one positive scan are considered unconfirmed responses until they have a second confirming scan at least 9 weeks later. Both confirmed and unconfirmed responses were reported at the recent ASCO conference.


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