PDS Biotechnology Corporation

Greetings. Welcome to PDS Biotech's third quarter 2022 earnings conference call and webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this call is being recorded. At this time, I'll hand the conference over to Gabby DeGravina, CG Capital. Gabby, you may now begin.

Good morning, and welcome to PDS Biotechnology's third quarter 2022 earnings conference call and audio webcast. With me today from the company are Dr. Frank Beduado, 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 September 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 at the SEC shortly. The company's press release is available on PDS's 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 conditions, 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 risks can be found in PDS Biotech's most recent filings with the SEC. We were 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 required by applicable law or regulation, PDS Biotech undertakes no obligation to update the forward-looking statements included today to reflect subsequent events or circumstances. With that, I would now like to turn the call over to Dr. Frank Beruado. Frank?

Thank you, Gabby, and thank you to all for joining us on our quarterly call today. During the third quarter of this year, we achieved some major milestones as we continue to progress the development of our oncology pipeline, and particularly our lead candidate, PDS0101, towards registrational trials. PDS0101 is an investigational immunotherapy designed to treat human papillomavirus or HPV-positive cancers. Before going through our quarterly and other business updates, I want to remind everyone that there are two key obstacles that have limited broader application of immunotherapy in the treatment of cancer, despite the revolutionary success of checkpoint inhibitors. The first challenge has been the limited ability to induce in the body the right type of killer T cells with the right killing potency meaning polyfunctional or multi-cytokine inducing killer T cells, as well as induction of these killer T cells in the right quantity. We refer to this as the critical three Rs of T cell activation, right type, right potency, right quantity. We know today that the induction of adequate active tumor infiltrating killer T cells is crucial for effective, endurable, or long-term immunotherapy. The second limitation is inability to overcome tumor immune suppression beyond the immune checkpoint-specific mechanisms currently addressed by checkpoint inhibitors. We know today that tumors utilize a variety of mechanisms independent of the immune checkpoints to suppress T cell attack. The ability to more broadly overcome tumor immune suppression, while also generating potent tumor-attacking T cells, presents the potential to more effectively treat a broader percentage of cancer patients, including terminally ill cancer patients, as our current data suggests. At PDS Biotech, Our technology platforms are designed to specifically address these two critical limitations of immunotherapy. We believe this proprietary approach to immunotherapy could clearly differentiate PDS Biotech from our peers. With regards to in vivo CD8 killer T cell induction, at the Society for Immunotherapy of Cancer Conference, known as SITC, this past week, Our collaborators at the National Cancer Institute and at the MD Anderson Cancer Center presented the results of immunological studies performed as part of their respectively led phase two clinical trials. These studies were aimed at further documenting the immunological mechanisms by which Versamune and Versamine plus IL-12 work. They also document the types of immune responses generated and their correlation with clinical efficacy. The MD Anderson poster reported the induction of polyfunctional CD8 T cells, which were shown to infiltrate the tumors when PDS0101 is administered to locally advanced cervical cancer patients in combination with standard of care chemoradiotherapy. No increase within the tumors of killer T cells has been reported by MD Anderson in patients who only receive chemoradiotherapy. In the MD Anderson presentation, they report an increase in the tumor DNA in the blood after chemoradiation. They also report an increase in the killer T cell population as a result of PDS0101 dosing. The studies demonstrate subsequent elimination of the blood circulating tumor DNA. This increase in tumor infiltrating CD8 killer T cells correlates with clinical responses in nine out of nine patients who had greater than 60% tumor shrinkage at midpoint evaluation. Complete responses with no evidence of disease in eight of the nine patients was seen by day 170. One patient, due to events not related to treatment, only received three of the five PDS-0101 doses. This is the only patient whose treatment did not result in a complete response. The MD Anderson data is especially illuminating because the immune responses are not confounded by the presence of any other immunotherapy. The observed immune responses are solely attributable to PDS0101. The National Cancer Institute also reported immunological data resulting from the administration of the PDS0101-based triple combination in checkpoint inhibitor refractory patients. This study also demonstrated the induction of HPV16-specific killer T cells in the blood of treated patients. confirming the immunological role of PDS0101. A significant increase in granzyme B-inducing CD8 T cells was also demonstrated. Granzyme B is associated with killer T cells that have the ability to target and kill cancer cells. We believe the results reported at SITC support the potential of versamine-based products to successfully overcome the first critical limitation of immunotherapy by generating the right type, right quantity, and right potency of tumor-infiltrating killer T cells in advanced cancer patients. The second challenge is more broadly overcoming mechanisms used by tumors to evade detection by the immune system. As cancer progresses, multiple regulatory mechanisms are co-opted by the tumors to evade attack by T cells. Some of these mechanisms are independent of the immune checkpoints that are blocked by checkpoint inhibitors. For example, in the difficult to treat HPV positive cancer population, the response rate with checkpoint inhibitors is reported to be about 13 to 20%. In the versatile 002 study, we appear to demonstrate in the early data in checkpoint inhibitor naive patients that by blocking the immune checkpoints with Keytruda and promoting HPV-specific CD8 T-cell induction with PDS0101, that we improve the response rate to over 40%. In the National Cancer Institute study, Using the Versimune plus IL-12 platform in the triple combination study, in a similar population of HPV-positive cancer patients who are naive to checkpoint inhibitor therapy, the National Cancer Institute reported an objective response rate of 88%. We believe this may be due to the fact that the triple combination is able to more effectively overcome the tumor immune suppression therefore making a larger percentage of tumors more susceptible to attack by the PDS0101-induced killer T cells. Also, we see in this population a 75% survival rate at 25 months. The Keynote 048 study reports an overall survival of 51% at 12 months, with the combination of chemotherapy and Keytruda in recurrent metastatic head and neck cancer. Further evidence of this effect is seen in the checkpoint inhibitor refractory arm of the triple combination study. In this population, in the patients who received the optimal dose, the National Cancer Institute reported an objective response rate of 63%. Historically, this patient group has an objective response of less than 10%. Also, in the full cohort, including those who received both optimal and suboptimal dose combinations, the National Cancer Institute reports a 66% survival after a median of 16 months of follow-up. The historical median survival for this population is reported to be only 3 to 4 months. These results suggest that the triple combination may be effective in addressing one of the key limitations of immunotherapy, which is broadly overcoming tumor immune suppression beyond what is achievable with checkpoint inhibitors alone. As you can see in the table, we have strategically collaborated with some of the most respected cancer centers in the world to perform this broad range of studies to enable us to more quickly 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 registrational trials. As we look ahead to 2023 and beyond, our key priority is to advance PDS 0101 as rapidly as possible to commercialization in as many indications as feasible. To date, we have reported phase two efficacy data from over 60 patients and safety data from over 100 patients in three trials. And we are encouraged by the fact that the clinical and immunological results continue to be consistent and to demonstrate the potential efficacy and safety of PDS0101. The data generated in the versatile 002 trial to date, for example, has allowed us to determine that the dual combination of PDS0101 and Keytruda may be most suitable to address recurrent metastatic checkpoint inhibitor-naive HPV16-related head and neck cancer. However, in more advanced checkpoint inhibitor refractory disease, The data generated by the National Cancer Institute using Diverse Immune Plus IL-12 platform in the triple combination suggest that in such advanced disease, the ability to more broadly overcome tumor immune suppression while generating tumor attacking T cells makes this our preferred combination to further evaluate in this patient population in a registrational trial. As you are aware, PDS-0101 in combination with Keytruda has been granted fast track designation by the FDA. We met in the third quarter with the FDA to discuss the potential to progress the combination into a registrational trial. We announced this quarter that based on a successful FDA meeting, PDS-Biotech has begun the process of preparing next steps towards a registrational trial in 2023. The FDA provided guidance on key elements of the clinical NCMC program that will support the submission of a biologics license application for our lead asset, PDS0101. The guidance received from the FDA ahead of completing the Phase II trial has the potential to speed up our development timeline by approximately one year. Similarly, with the NCI National Cancer Institute-led triple combination, we announced this quarter that PDS Biotech and the National Cancer Institute have decided to end recruitment into the trial to focus our initial attention on progressing development of the triple combination in the checkpoint inhibitor refractory population. To this end, both PDS Biotech and the National Cancer Institute are encouraged by the data to date and remain hopeful that we will meet with the FDA before the end of the year, depending on the FDA meeting schedule and upcoming holidays. As I alluded to in our last conference call, if we did get the go-ahead from the FDA to progress the versatile 002 trial into a registrational trial, it would take precedence over initiation of PDS 0103. As a result, we have moved the preparation date for the PDS 0103 IND to the first half of 2023. Clinical manufacturing of the product is progressing as previously stated. I would now like to turn the call over to Lauren for her to take us through the clinical data recently presented at SITC by our collaborators at MD Anderson Cancer Center and the National Cancer Institute. Lauren?