Discussion topics to include pathology and prevalence of HPV16-positive head and neck cancer, VERSATILE-003 Phase 3 clinical trial design and initiation

PRINCETON, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced a Key Opinion Leader ("KOL") event to discuss the pathology and growing prevalence of HPV16-positive head and neck squamous cell carcinoma ("HNSCC") as well as the Company's upcoming VERSATILE-003 Phase 3 clinical trial of Versamune HPV + pembrolizumab for first-line treatment of recurrent and/or metastatic HPV16-positive HNSCC.

The KOL event will take place on Tuesday, December 17, 2024, at 12 p.m. ET and panel participants include:

• Francis "Frank" Worden, M.D., Rogel Cancer Center, University of Michigan
• Kevin Harrington, MBBS, Ph.D., The Institute of Cancer Research, United Kingdom

The event will be moderated by Kirk Shepard, M.D., PDS Biotech's Chief Medical Officer.

Webcast and Registration Details

Date: Tuesday, December 17, 2024
Time: 12 p.m. - 1:30 p.m. ET
Registration: Click here

About Our Speakers

Francis Worden, M.D., is a clinical professor awarded the Nancy Wigginton Oncology Research Professor of Thyroid Cancer endowed chair at the Rogel Cancer Center at the University of Michigan. He is a clinical investigator with the multidisciplinary head and neck cancer and lung cancer teams. Dr. Worden is a leading expert in the treatment of HPV-positive oropharyngeal cancer. He has co-authored over 190 peer-reviewed articles and participated in approximately 20 clinical trials with three ongoing trials in HNSCC, including the VERSATILE-002 trial. Dr. Worden received his medical degree from the Indiana University School of Medicine. He completed a combined internal medicine and pediatrics residency at the Detroit Medical Center and finished a medical oncology/hematology fellowship at the University of Michigan. In 2000, Dr. Worden joined the University of Michigan Rogel Cancer Center faculty.

Kevin Harrington, MBBS, Ph.D., is Head of the Division of Radiotherapy and Imaging at The Institute of Cancer Research in the United Kingdom. Dr. Harrington is a Professor of Biological Cancer Therapies at The Institute of Cancer Research. He was the principal investigator for KEYNOTE-048, the pivotal clinical trial that supported the U.S. Food and Drug Administration approval for the use of pembrolizumab and pembrolizumab + chemotherapy in the first-line treatment of recurrent and/or metastatic HNSCC. Earlier this year, Dr. Harrington presented the results of the VERSATILE-002 clinical trial during the European Society of Medical Oncology Congress. He studied medicine at St. Bartholomew's Hospital in London and began focusing on head and neck cancer as a Ph.D. student at Hammersmith Hospital. Dr. Harrington completed post-doctoral research in molecular medicine at the Mayo Clinic, before being appointed as a Consultant Oncologist at The Royal Marsden National Health Service Foundation in 2001. He has published more than 600 articles on cancer treatment.

About PDS Biotechnology

PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech's lead investigational targeted immunotherapy Versamune HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

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Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the "Company") and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company's management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," "forecast," "guidance", "outlook" and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company's ability to protect its intellectual property rights; the Company's anticipated capital requirements, including the Company's anticipated cash runway and the Company's current expectations regarding its plans for future equity financings; the Company's dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company's operations or require the Company to relinquish rights to the Company's technologies or product candidates; the Company's limited operating history in the Company's current line of business, which makes it difficult to evaluate the Company's prospects, the Company's business plan or the likelihood of the Company's successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune HPV, PDS01ADC and other Versamune and Infectimune based product candidates; the future success of such trials; the successful implementation of the Company's research and development programs and collaborations, including any collaboration studies concerning Versamune HPV, PDS01ADC and other Versamune and Infectimune based product candidates and the Company's interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company's product candidates; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company's currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company's ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company's ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company's control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Versamune and Infectimune are registered trademarks of PDS Biotechnology Corporation.

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