PDS Biotechnology Corporation

Hello and welcome to the PDS Biotechnology fourth quarter 2022 and full year earnings call and conference call. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Gabby D. Gravina of CG Capital Investor Relations. Please go ahead.

Good morning and welcome to PDS Biotechnology's fourth quarter and year-end 2022 earnings conference call and audio webcast. On the call 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 and full year ended December 31st, 2022. We encourage everyone to read the press release as well as PDS Biotech's report on Form 10-K, 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 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 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 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. So, 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. With that, I will hand the call over to Dr. Frank Situato. Frank?

Thank you, Gabby, and thank you all for joining us on our year-end call today. We have made tremendous progress this past year, achieving several significant milestones as we continue to advance our oncology pipeline, most importantly, progressing closer towards a registrational trial for our lead candidate, PDS0101. PDS0101 is a novel investigational human papillomavirus or HPV-targeted immunotherapy that stimulates a potent targeted T-cell attack against HPV-positive cancers. Our goal is to commercialize PDS0101 as rapidly as possible by performing a well-designed phase three trial that maximizes our potential for both speed and success. Therefore, our key priority in 2023 is to move forward efficiently with finalizing the development of PDS0101 for the treatment of HPV-positive head and neck cancer in immune checkpoint inhibitor for ICI-naive patients. Before we move into the fourth quarter updates, I would like to briefly mention the recent meetings we have had with the US Food and Drug Administration, also known as the FDA. These meetings were held to discuss the registrational pathways for our two most advanced phase two trials, Versatile 002 and the National Cancer Institute-led or NCI-led triple combination trial. In both meetings, the FDA provided very useful guidance on key elements of both trial designs. Therefore, we will be transitioning into phase three clinical development this year. informed by the ongoing and maturing data from Versatile 002. This randomized controlled phase three trial will investigate PDS0101 in combination with Keytruda versus Keytruda alone in ICI-naive patients with recurrent or metastatic HPV16 positive head and neck cancer. The phase three trial will be called Versatile 003. In parallel, we will continue activities necessary to progress the NCI-led triple combination of PDS-0101, PDS-0301, formerly known as M9241, or NHS IL-12, with an approved immune checkpoint inhibitor, or ICI. Let's now touch on the Versatile 002 Phase 2 trial update. The trial is investigating PDS0101 in combination with Merck's ICI Keytruda, also known as Pembrolizumab, in both ICI-naive and refractory patients. Interim results presented at ASCO 2022 demonstrated promising efficacy and safety profiles for the combination. Data from 17 patients with available imaging showed an objective response rate of 41%, which included confirmed and unconfirmed responses. At nine months of follow-up, the overall survival rate was 87%. In the published Keynote 048 study, the nine-month overall survival rate for Keytruda monotherapy was approximately 60%. We believe that the parameter of highest relevance to the FDA is the overall survival. As in many immunotherapies, improvements in objective response rate, or ORR, and progression-free survival, or PFS, have not translated to improved overall survival, or ROS. It should be noted that in recurrent or metastatic head and neck cancer, where an FDA-approved drug has been shown to improve survival, such as Keytruda has, overall survival becomes the most important criteria by which the new drug or combination will be evaluated. As a reminder, this program has received fast track designation from the FDA. Following our FDA meeting in the third quarter of 2022, we initiated a tech transfer of the PDS 0101 manufacturing process to our selected commercial manufacturer for the scale-up and production of PDS 0101 for Versatile 003. The transfer was successful, and the Phase III clinical product was successfully completed this quarter. The final sections of the Chemistry, Manufacturing, and Control section, also known as CMC, of the amended IND are in progress. Most importantly, We are gaining insight into the potential progression-free survival and overall survival data that continue to mature from Versatile 002. These PFS and overall survival data are critical to our ability to design the statistical portion of the phase three clinical study. The duration it has taken for us to begin to gain insight to these critical parameters and possible endpoints is highly encouraging as it signifies that the majority of patients are staying alive and not rapidly progressing. As I mentioned, overall survival is the most important parameter by which the FDA typically prefers to confirm approval of oncology products. We are hopeful, based upon previously presented and ongoing results, that we will be able to show improved PFS and OS with the PDS-0101-Ketruda combination. We are also currently in communication with the European regulatory agencies and expect feedback on the Versatile 003 Clinical Protocol and CMC section in the second quarter of this year. If possible, we intend to also incorporate their comments into the final protocol design that will be submitted to the FDA and other country-specific agencies for review. We therefore expect to file an amended IND in the third quarter of this year, which should allow us to present the protocols to the Investigational Review Boards, or IRB, for the various sites as we perform the process of site activation. Overall, these startup activities typically take four to six months. We are working towards the goal of opening up the trial in the fourth quarter of this year and expect the trial to be run at 90 to 100 global sites. There are a number of reasons why we have decided to progress the versatile 003 trial ahead of the triple combination. First of all, obtaining an approval for the PDS-0101 product specifically simplifies our development of future combinations of other agents such as PDS-03-01 with PDS-01-01 from a regulatory perspective. IND-related activities are further progressed with this program due to the earlier FDA meeting and also the clear regulatory pathway for combination of an investigational agent with a commercial approved product. Importantly, we have fast track for this program and with our clinical design have good potential for PDS0101 to become the first approved immunotherapy to address HPV-positive cancer. In parallel, we continue to aggressively work towards getting the triple combination to a similar position and will provide updates on progress in the future. So transitioning to updates on the NCI-led Phase II triple combination trial for patients with advanced HPV-positive cancers. Last month, we announced a successful meeting with the FDA for the triple combination of PDS0101 and PDS0301 with an SDA-approved ICI for the treatment of recurrent or metastatic HPV16-positive ICI refractory head and neck cancer. Our ability to replace the investigational ICI with a commercial ICI simplifies the regulatory pathway to develop the triple combination. Our strategic decision to acquire the novel antibody conjugated IL-12, now PDS-03-01, has mitigated operational risk and potential hurdles in moving the program forward. It has also encumbered the agent for broader use in our pipeline. Importantly, by replacing the investigational ICI with a commercial ICI, and acquiring PDS 0301, we also simplified and clarified the future economics pertaining to the current and future commercial combinations of PDS 0301 with our pipeline products or other products. It is also important to note that the PDS 0301 acquisition deal does not financially burden development of the product as very minimal payments are due ahead of successful commercialization. This agreement also includes the supply of the clinical PDS 0301 product by Merck KGAA, Darmstadt, Germany. This partnership, as you can see, therefore maximizes the potential for development and financial success for both parties. We are extremely pleased with our partnership with Merck KGAA and with the updated survival outcome results we reported from the triple combination last quarter. EDS Biotech has selected advanced ICI refractory HPV16 positive head and neck cancer as the initial indication for which the triple combination will be developed. These patients have few options and no clear effective standard of care therapy, despite the severity of the disease. Survival data from the trial has been encouraging and the triple combination therapy appears to be reasonably well tolerated with grade three adverse events reported in 43% of patients and grade four treatment related adverse events reported in only of patients. In December, we reported expanded National Cancer Institute interim data that included 50 patients. Of those, 37 HPV16 positive patients were evaluable, and 29 out of the 37 patients had failed ICI treatment and were therefore ICI refractory. Median overall survival was 21 months in the 29 ICI refractory patients who received the triple combination. Of note, the reported historical median overall survival in patients with HPV-positive ICI refractory disease and treated with an ICI is only three to four months. As we announced on February 27, after our FDA meeting, our trial of the triple combination will initially target ICI refractory HPV 16 positive head and neck cancer. The best published Median overall survival data to date in ICI refractory head and neck cancer is 8.2 months. The expanded data continue to demonstrate the durability and tolerability of the PDS0101-based triple combination therapy in advanced HPV-positive cancers, and it is exciting to see consistency in the data with each update. Moving on to the MD Anderson-led Immunocere Phase II trial. This study is being performed in patients with locally advanced cervical cancer with large tumors over five centimeters in size. Remarkable clinical and biomarker data were presented at SITC 2022. 100% of patients treated with the combination of PDS-0101 and standard of care chemoradiation therapy had a clinical response with tumor shrinkage greater than 60%. Eighty-nine percent or eight of the nine patients treated with the combination demonstrated a complete response or CR with no evidence of the disease on day 170. These results are encouraging, and we look forward to updating you when additional data becomes available. The Mayo Clinic continues studying PDS0101 in early stage pre-metastatic HPV16 positive oral cancer in a phase two trial. Patients continue to be recruited and treated, and we are hopeful that we'll see data before the end of this year. As we've mentioned before, the Mayo Clinic study is an investigator-initiated trial, meaning we do not have control over its progress, enrollment, and treatment or the timing around data readouts. However, our expectation is that study investigators would present preliminary data when available at a medical congress. Moving on to our broader oncology pipeline. Tech transfer for PDS01-03 is in progress. Pending availability of manufacturing slots and all the activities associated with initiating Versatile 003, we are hoping to file the IND in the second half of this year. We expect to file the IND for PDS 01-02 in 2024. Before I turn the call over to Lauren, I will reiterate that we plan to initiate the Versatile 003 phase three trial by the fourth quarter of this year. We continue to make significant progress with the program. Clinical manufacturing is complete. Late-stage CMC activities are ongoing, as well as finalization of the clinical protocol, and we expect to file the amended IND in the third quarter. I will now turn the call to Lauren to walk us through the clinical updates.