Friday, November 15, 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.
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Progress Toward Phase 3 With New Phase 2 VERSATILE-002 Data. PDS Biotech Reported 3Q24 loss of $10.7 million or $(0.29) per share, a slightly lower loss than we estimated. Earlier this week, modifications to the IND protocol for the Phase 3 VERSATILE-003 trial were submitted to the FDA. Approval is expected by mid-December, which would allow the trial to begin in early 2025.
New Phase 2 VERSATILE-002 Data Analysis Shows Outcomes Were Maintained Or Improved. As additional patients complete their follow-up periods, further analysis of the data has shown improvements over the previous interim reports. The overall survival has been unchanged at 30.0 months, although the lower limit of the confidence interval has increased to 20 months. This compares with 17.9 months for published Keytruda studies. Overall response rate, complete response rate, and disease control rates have improved as well.
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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
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