PDS Biotechnology Corporation

Greetings and welcome to the PDS Biotech first quarter and 2025 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Moyer, LifeSite Advisors. Thank you, sir. You may begin.

Thank you, operator. Good morning, everyone, and welcome to PDS Biotech's first quarter 2025 results and clinical programs update call. I am joined on the call today by the following members of the company's management team. Dr. Frank Badu-Addo, Chief Executive Officer, Dr. Kirk Shepherd, Chief Medical Officer, and Lars Bosgaard, Chief Financial Officer. Dr. Badu-Addo will begin with an overview of the company's recent progress in its clinical development program Mr. Bosgarb will review the financial results for the quarter ended March 31, 2025, and Dr. Shepherd will then join the call to help address questions from our covering analysts. As a reminder, during this call, we will be making forward-looking statements which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in our filings with the SEC. including our quarterly reports on Form 10-Q and annual report on Form 10-K, and cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information. Now, I'd like to turn the call over to Dr. Badu Adel. Frank?

Thank you, Mike, and good morning, everyone. It's our pleasure to speak with you again and to provide this brief update on our progress in advancing our clinical programs. The first quarter of 2025 and recent weeks have been a productive period for PDS Biotech, led by the initiation of our Versal 003 Phase III clinical trial of Versamune HPV plus pembrolizumab. Versamune HPV plus pembrolizumab is a potential treatment for first-line recurrence and or metastatic HPV16 passive head and neck squamous cell carcinoma or head and neck cancer. Patients with recurrent or metastatic HPV16-positive head and neck cancer are difficult to treat and represent a large, fast-growing population in need of targeted therapies to treat the underlying cause of the cancer. It is projected that by the mid-2030s, HPV16-positive head and neck cancer will become the most prevalent type of head and neck cancer in the United States and Europe. Considering the strength and durability of the clinical responses observed in our Versatile 002 Phase 2 study, we are excited to get the Versatile 003 registrational trial underway and are confident in the potential of the combination of Versamine HPV and Pembrolizumab to significantly improve outcomes for patients with recurrent and or metastatic HPV16 positive head and neck cancer. We are pleased to announce that new sites, including Mayo Clinic sites, were recently added to the trial, and we continue the process of activating additional clinical sites. We look forward to the continued progression of this trial. As we announced previously, the Versatile 003 trial design includes approximately 350 patients. The two-arm registrational trial design has been given the go-ahead by the U.S. Food and Drug Administration, or FDA. The two arms of the trial include a treatment arm of the Versamune HPV and Pembrolizumab combination versus the control arm of Pembrolizumab only. Patients are enrolled in a two-to-one randomization. Median overall survival is the primary endpoint. The trial design is informed by the observed durability of the clinical responses in our Versatile 002 clinical trial seen over the last year and a half with the most recent data presented at the European Society for Medical Oncology, ESMO Congress in September. The encouraging patient survival and clinical responses coupled with promising tolerability as seen in the Versatile 002 clinical trial will be the subject of the poster presentation of the 2025 American Society of Clinical Oncology Annual Meeting, or ASCO. These data underscore our belief in the potential of the combination to be the first HPV16 targeted therapy for head and neck cancer, and a significant advancement in the treatment of the growing population of patients with HPV16 positive head and neck cancer. The Versatile 003 trial in progress is the first phase three trial in the high-risk HPV 16 population and has also been accepted for presentation at the 2025 ASCO annual meeting. Thirdly, Mayo Clinic will present the results of the MC200710 study investigating versamine HPV alone or with pembrolizumab prior to surgery or radiation therapy for locally advanced HPV16 positive oropharyngeal cancer. All three presentations will be held on Monday, June the 2nd, 2025, from 9 a.m. to 12 p.m.