PDS Biotechnology Corporation

Greetings. Welcome to PDS Biotech second quarter of 2022 earnings call and webcast. At this time, all participants are in listen-only mode. Any question and answer session will follow the formal presentation. If anyone today should require operator assistance during the conference, please press star zero from your telephone keypad. Please note that this conference is being recorded. At this time, I'll turn the conference over to Gabby DeGrazina with the best relations. Gabby, you may now begin.

Good morning, and welcome to PDS Biotechnology's second quarter 2022 earnings conference call and online webcast. With me today from the company are Dr. Frank Bedouinot, Chief Executive Officer, Dr. Lauren V. Wood, Chief Medical Officer, and Matt Hill, Chief Financial Officer. Earlier this morning, PDS Biotech issued a press release announcing financial results for the quarter ended June 30th, 2022. We encourage everyone to read the press release as well as PDS Biotech's report on Form 10-Q, which will be filed with the SEC shortly. The company's press release is available on the PDS website at pdsbiotech.com. In addition, this conference call is being webcast and will be archived on the company website for future reference. Before we begin, we need to remind everyone that on today's call, the company will be making forward-looking statements regarding regulatory and product candidate development plans, as well as research activities. Certain information in this presentation may include forward-looking statements, including within the meaning of Section 21 of the United States Securities Exchange Act of 1934, as amended, and Section 27 of the United States Securities Act of 1933, as amended. concerning PDS Biotechnology Corporation 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. These statements are subject to risk and uncertainties that may cause actual results to differ from those forecasted. A description of these can be found in PDS Biotech's most recent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Except to the extent which required by applicable law or regulation, PDSB undertakes no obligation to update the forward-looking statements included today to reflect subsequent events or circumstances. As you can see, we're utilizing slides to help summarize our programs and milestones, and aiming to streamline the presentation of background information and updates. We know your time is a precious commodity, and we want to leave as much time as possible for Q&A. Your feedback on this structure would be welcome. With that, I would now like to turn the call over to Dr. Frank Beduado. Frank?

Thank you, Gaby, and thanks to all of you for joining us this morning. This past quarter, the PDS Biotech team has worked diligently to advance the development of our oncology and infectious disease pipelines, and we have made tremendous progress on these fronts. Here, you can see the broad overview of our lead versimune-based candidate, PDS0101, an investigational immunotherapy designed to treat human papillomavirus, or HPV16-associated cancers. As a reminder, our Versamune technology platform promotes the delivery of tumor-associated proteins, also called antigens, to the immune system and simultaneously activates the immune system to induce antigen-specific killer T-cells. TDSR101 combines Versamune with HPV16 antigens and therefore promotes the induction of CD8-positive killer T cells that target and kill tumors that are HPV16-positive. Our second proprietary oncology platform combines Versimune with cytokines such as IL-12. This combination of Versimune with cytokines leads to the reduction in the population of immune-suppressive cells such as myeloid-derived suppressor cells, also called MDSC. Preclinical data with this platform suggests that this technology may allow us to treat a broader population of advanced cancer patients beyond those who respond to checkpoint inhibitors. We are evaluating PDS0101 across four ongoing phase two clinical trials. In the three most progressed studies, we are evaluating PDS0101 as a combination treatment with various anti-cancer agents in advanced and refractory cancers. We are studying these combinations in multiple HPV-associated diseases and at different stages of the disease from locally advanced cancer to terminally ill patients with recurrent metastatic checkpoint inhibitor refractory disease. We are performing these studies in collaboration with some of the most respected cancer centers in the world. In the fourth trial, investigators at Mayo Clinic are leading a study to evaluate PDS0101 as immunotherapy or in combination with Keytruda in early stage oral cancer. It is important to note that our approach of performing this broad range of studies is to enable us to understand in which indications the various combinations may work better and to allow us to select the most promising combinations and indications to rapidly progress into pivotal trials. This broad approach allows us to mitigate the risk of product development as we know that not every combination is likely to be as promising for every disease indication. As we look ahead, our key priority is to advance PDS0101 as rapidly as possible to commercialization. To date, we have reported efficacy and or safety data from 80 patients in two trials. and we are highly encouraged by the fact that the results continue to demonstrate the promising efficacy and safety of PDS-0101. These results have also been accurately predicted by our preclinical studies, which is highly encouraging. The clinical data generated to date is beginning to elucidate which indications and combinations could potentially be selected for pivotal studies. Importantly, we presented very encouraging data in June at ASCO from two of our ongoing Phase II clinical trials. The versatile 002 study is evaluating PDS0101 in combination with Merck's anti-PD1 checkpoint inhibitor therapy, Keytruda, or pembrolizumab in patients with HPV-16 positive recurrent and or metastatic head and neck cancer. The National Cancer Institute-led triple combination study is evaluating PDS-0101 in combination with a checkpoint inhibitor and NHS IL-12 in both checkpoint inhibitor-naive and refractory patients in a range of advanced HPV-positive cancer patients who have failed prior therapy. As I mentioned earlier, this combination of Versamune, a checkpoint inhibitor, and IL-12 may enable us to treat a broader population of refractory and very difficult to treat patients. Dr. Lauren Wood will be covering highlights from the ASCO data presentations shortly. In addition to the data presentations, we also have some exciting news announcements related to the Versatile trial during the quarter. As we announced in May, we received notification of the acceptance of the Clinical Trial Application, or CTA, to allow expansion of the versatile study into the UK. Our strategy is to expand the trial into various sites outside of the United States. Due to the time taken to prepare international sites for a trial, we believe that this approach of getting the various regulatory agencies familiar with our product could facilitate rapid transition to an efficiently enrolling pivotal trial to accelerate development. This goal of expanding the Versatile 002 trial into the European Union based on recent data is accounted for in our financial projection. We will provide updates as enrollment in Europe begins. Also during the quarter, based on the results so far from the Versatile 002 trial, we were granted fast track designation by the FDA for PDS-0101 in combination with pembrolizumab for the treatment of HPV 16 positive head and neck cancers. As you know, the FDA's fast track designation program is designed to aid in the development and to expedite the review of drug candidates that could potentially treat serious or life-threatening conditions and that demonstrate the potential to address an unmet medical need. Lastly, on Versatile 002, our Independent Safety Data Monitoring Committee, or DMC, met for its scheduled review of the administration of PDS-0101 in combination with Keytruda. The committee safety review included data from 43 patients in both the checkpoint inhibitor naive and checkpoint inhibitor refractory groups. This more than doubles the 19 patients whose data was presented at ASCO in June. EDS-0101 in combination with Keytruda continues to appear safe and well tolerated. Specifically, as of the DMC review, there were no drug discontinuations related to toxicity and no grade 3 or higher treatment-related adverse events attributed to the combination. The DMC recommended continuing the trial with no modifications. The safety profile of PDS-0101 plus Keytruda continues to hold up. and we continue to believe that the versamine-based immunotherapies may enable not only more effective cancer therapies, but also safer and better tolerated therapies. Our third PDS-0101 trial is the ongoing MD Anderson-led Phase II ImmunoServe study, which is evaluating PDS-0101 in combination with standard of care chemoradiotherapy or CRT in patients with locally advanced cervical cancer who have either lymph node metastasis or tumors of size greater than five centimeters. This study is evaluating clinical responses as well as immunological biomarkers both in the tumor environment and in the blood circulation to better understand how PDS-0101 may be working immunologically and how it may improve standard of care. In this trial so far, promising clinical results as well as immunological data have been generated. And we have been informed by the MD Anderson team that an abstract has been submitted for presentation at the Society for Immunotherapy of Cancer or SITC meeting in November. To avoid jeopardizing acceptance of their abstract, we will wait until the embargo has been lifted to present the data. We continue to believe that it is in the best interest of all shareholders for our data to be scrutinized, peer reviewed, and presented to a larger audience of investors, potential partners, and key experts in the field. As we've discussed previously, we are thrilled to have established a relationship with the Mayo Clinic. This relationship has progressed from simply being a site for the versatile 002 study to now include the ongoing investigator-initiated trial where PDS-0101 is being evaluated both as a monotherapy and in combination with Keytruda. This study is being conducted in newly diagnosed patients with HPV16-associated oropharyngeal cancer. Enrollment is ongoing, and we will provide updates as they become available. Finally, a quick regulatory note here. We plan on meeting with the FDA this quarter to discuss the registrational path forward for PDS-0101 in combination with Keytruda and are also expecting to meet with the FDA later in the year to discuss the NCI-led triple combination study. We are hopeful that these meetings could green light progression into pivotal trials for both programs. We project based on current results that the dual combination will focus on checkpoint inhibitor naive patients, and the triple combination will address checkpoint inhibitor refractory indications due to a greater breadth of anti-immune suppressive activity. Our goal is to prioritize commercialization of PDS0101, and this could therefore cause us to adjust the timelines for initiation of the PDS-0102 and PDS-0103 clinical studies. PDS-0102 and PDS-0103 are progressing according to schedule and are currently in clinical stage manufacturing. Similar to our reverse immune oncology pipeline, we continue to leverage strategic collaborations to advance our infectimmune infectious disease programs with minimal capital outlay. Last month, our collaborator, Dr. Ted Ross, and his team presented preclinical data on the universal flu vaccine at the 41st American Society of Virology meeting. Based on these promising results, we continue to work with the National Institute of Allergy and Infectious Diseases, also known as NIAID, to advocate for advancing PDS0202 into the clinic. Discussions with the NIAID continue to progress. As part of this process, last month, Dr. Ted Ross and Professor Jerry Woodward, PDS Biotech's collaborator at the University of Kentucky School of Medicine, presented the preclinical universal flu efficacy data to the larger NIAID group. Last week, PDS presented the Infectimmune Clinical Manufacturing and Human Safety data to NIAID program staff. I'll turn the call over to Lauren, who will discuss these data in detail. Lauren?