PDS Biotechnology Corporation

Hello, and welcome to the PDS Biotechnology second quarter 2023 earnings call and webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may press star one at any time to be placed into question queue. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to your host, Gabby DeGravina, Investor Relations. Please go ahead, Gabby.

Good morning, and welcome to PDS Biotechnology's second quarter 2023 earnings conference call and audio webcast. On the call from the company are Dr. Frank Bedouinot, Chief Executive Officer, Matt Hill, Chief Financial Officer, and Dr. Lauren V. Wood, Chief Medical Officer. Earlier this morning, PDS Biotech issued a press release announcing financial results for the quarter ended June 30th, 2023. 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 clinical 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 the current beliefs of the company's management, as well as assumptions made by and information currently available to management. These statements are subject to risks 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. 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 required by applicable law or regulation, PDSB undertakes no obligation to update the forward-looking statements included today to reflect subsequent events or circumstances. I will now hand the call over to Dr. Frank Feduetto. Frank?

Thank you, Gabby, and thanks to all for joining our second quarter 2023 call this morning. We are pleased with the progress we have made so far this year. Our primary goal is to create groundbreaking therapies that can significantly revolutionize cancer treatment. Our current primary focus is on advancing and commercializing our lead clinical candidate, PDS0101, designed for the treatment of recurrent or metastatic HPV16-positive head and neck cancer. EDS-0101 is an innovative, investigational HPV16-targeted immunotherapy that stimulates a potent and precise T-cell attack on HPV16-positive cancers. In the upcoming controlled and randomized Versatile 003 trial, we will examine PDS-0101 in combination with Merck's anti-PD-1 therapy Keytruda or Pembrolizumab compared to Keytruda monotherapy, which is the current standard of care for first-line treatment of recurrent or metastatic head and neck cancer. I am pleased to mention that we filed the final Versatile 003 Phase III protocol with supporting chemistry, manufacturing and controls or CMC information to our existing IND last week on schedule as planned and previously announced. I congratulate the PDS Biotech team on achieving another key milestone on our path to commercialization of PDS 0101. This filing moves us a step closer to another significant upcoming milestone. the initiation of the Phase III trial in the fourth quarter of this year. As you can imagine, we are all eagerly looking forward to the commencement of Versatile 003. This will hopefully move us towards the filing of a biologics license application, or BLA, and the increased potential to get PDS-0101 successfully commercialized and available to head and neck cancer patients who are in desperate need of safer and more effective therapies. Advanced head and neck cancer, as many of you may already know, is one of the most devastating and debilitating cancers, with one of the highest suicide rates, and unfortunately, low response rates to current treatments. This quarter, we made significant progress on our Phase 2 Versatile 002 trial. We presented positive interim data, and the data was selected and featured at an expert head and neck cancer panel discussion session at this year's ASCO annual meeting. The data demonstrated a 12-month survival rate of 87%, with only 8% of patients experiencing grade 3 treatment-related adverse events. and no reports of more severe grade four or grade five toxicities. Dr. Wood will provide more details on the ASCO data momentarily. Additionally, the naive arm of Versatile 002 reached its efficacy threshold based on best objective response as per investigator assessment. The threshold for efficacy was achieved when 14 of the 54 immune checkpoint inhibitor naive patients achieved a confirmed objective response, indicating tumor shrinkage of 30% or more in these patients. This achievement suggests that there is a statistically significant additive effect of PDS-0101 over immune checkpoint inhibitor monotherapy, and this gives us more confidence to move into the phase three registrational trial. Just last month, we announced that biomarker data demonstrating the induction of multifunctional HPV16-specific T cell responses in patients receiving the PDS0101 and Keytruda combination treatment has been accepted for presentation at the European Society for Medical Oncology Congress 2023 or ESMO, this October. The immunological clinical data will showcase the potential of this immunotherapy combination to generate clinically relevant multifunctional HPV16-targeted killer in healthy T cells in advanced head and neck cancer patients. Moreover, the treatment has demonstrated minimal toxicity further underlining its potential as an effective approach to treat this challenging cancer. Beyond the versatile 002 achievements, we've continued to successfully progress our three other PDS0101 clinical programs, as well as the development of our novel antibody-conjugated IL-12 cytokine therapy, PDS0301, in multiple National Cancer Institute or NCI-led Phase II clinical studies. We recently announced that an oral presentation by the lead investigator on the prostate cancer program at the National Cancer Institute will take place at the Cytokines 2023 Annual Meeting. The presentation will detail results for the ongoing clinical study of our antibody-conjugated IL-12 in combination with the FDA approved standard of care chemotherapy docetaxel for metastatic prostate cancer. This phase two trial, which is the first clinical study of an immunocytokine with docetaxel in prostate cancer, is being led by the National Cancer Institute and is investigating the safety, immune responses, and clinical activity of the combination in metastatic castration-sensitive and castration-resistant prostate cancer patients. As we look to the remainder of the year and the first half of next year, we expect a number of key data readouts and milestones. For Versatile 002, we anticipate providing additional data updates on both the immune checkpoint inhibitor Naive and immune checkpoint inhibitor refractory cohorts late this quarter. As recruitment of the naive arm has been completed, we project that the final data will be reported late in the second quarter of 2024. With Versatile 003, as already mentioned, we anticipate initiation of the trial later this year. High on our list is also the National Cancer Institute-led triple combination study of PDS-0101, our antibody-targeted IL-12, and an immune checkpoint inhibitor. We expect data from the immune checkpoint inhibitor refractory arm of Versatile 002, as well as updated triple combination survival data among head and neck cancer patients to inform the statistical design of the intended triple combination registrational study. We also anticipate providing updates to the highly encouraging survival data with the triple combination that we reported late last year. Dr. Anne Klopp of MD Anderson Cancer Center provided exciting data on the ImmunoServe trial in high-risk cervical cancer patients with large tumors of five centimeters or more at the SITC conference in November 2022. This is an investigator-initiated trial, and we expect to have a steady update before the end of the year. The Phase II trial of PDS0101 as a neoadjuvant treatment in HPV16-related oral cancer is also in progress at Mayo Clinic. This is an investigator-initiated trial, and we have little control over the timing of data releases. However, we are hopeful that presentation of preliminary data from the trial at a scientific meeting will occur in the near future. Although our primary focus is on Versatile 003, we are also working to file our IND for PDS 0103 our Mach 1 targeted immunotherapy before the end of this year. At this time, I will hand over to Lauren to walk us through the recent data. Lauren?