GlobeNewswire Inc | Jan 12, 2022 08:00AM EST

January 12, 2022

FLORHAM PARK, N.J., Jan. 12, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Companys proprietary Versamune T-cell activating technology, today announced that the initial safety data from its VERSATILE-002 study has been accepted for presentation at the 2022 Multidisciplinary Head and Neck Cancers Symposium being held February 24-26, 2022, at the JW Marriott Phoenix Desert Ridge Resort and Spa, Phoenix, AZ.

The accepted abstract summarizes initial safety data from the ongoing Phase 2 study, being run in collaboration with Merck (known as MSD outside the US and Canada) (NCT04260126), which studies PDS0101 in combination with Mercks anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer. It was previously announced that the trial had achieved its preliminary safety benchmark in the first 12 patients.

We continue to be encouraged by the data and look forward to the presentation of safety data from this study, said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. The Multidisciplinary Head and Neck Cancers Symposium brings together experts in head and neck cancers from around the world and we look forward to sharing this data with this important group of physicians and scientists.

Abstract Number: 157Abstract Title Preliminary Safety of PDS0101 (Versamune +HPVmix) and Pembrolizumab Combination Therapy in Subjects with Recurrent/Metastatic Human Papillomavirus-16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)Presenter: Jared Weiss, M.D., Associate Professor of Medicine, Division of Oncology at UNC School of Medicine, UNC Lineberger Comprehensive Cancer Center

PDS Biotech is also conducting a Phase 2 clinical study in both second- and third-line treatment of multiple advanced HPV-associated cancers with the National Cancer Institute (NCI). A third Phase 2 clinical trial in first-line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center (IMMUNOCERV).

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Companys proprietary Versamune T-cell activating technology platform. 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 Companys 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. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

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 Companys 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 Companys ability to protect its intellectual property rights; the Companys anticipated capital requirements, including the Companys anticipated cash runway and the Companys current expectations regarding its plans for future equity financings; the Companys 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 Companys operations or require the Company to relinquish rights to the Companys technologies or product candidates; the Companys limited operating history in the Companys current line of business, which makes it difficult to evaluate the Companys prospects, the Companys business plan or the likelihood of the Companys successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune based products; the future success of such trials; the successful implementation of the Companys research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune based products and the Companys interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Companys product candidates; the success, timing and cost of the Companys ongoing clinical trials and anticipated clinical trials for the Companys current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Companys 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 acceptance by the market of the Companys product candidates, if approved; the timing of and the Companys ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Companys product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Companys control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 risk factors included in the Companys annual and periodic reports filed with the SEC. 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.

Investor Contact:

Rich CockrellCG CapitalPhone: +1 (404) 736-3838pdsb@cg.capital