PDS Biotechnology Corporation

Good morning and welcome to PDS Biotech's call to discuss the company's year-end 2023 financial results and clinical strategy update conference call. All participants are currently in listen-only mode. Following the formal presentation, we'll open up the call for a question and answer session. I would now like to turn the conference over to Tom Johnson with LifeSite Advisors. Please go ahead, sir.

Thank you, Operator, and good morning, everyone, and welcome to PDS Biotech's 2023 year-end results and clinical strategy update call. Today, we will discuss financial results for the year ended December 31, 2023, and provide a business and clinical programs update. This morning, the company issued a press release with these results, which are going to be found under the investor relations section of the PDS Biotech website. I am joined on the call today by the following members of the company's management team. Dr. Frank Beroadeau, Chief Executive Officer, Lawrence Boisgarde, Chief Financial Officer, and Dr. Kirk Sheppard, Chief Medical Officer. Dr. Beto Addo will begin with the corporate and clinical programs update, and then Mr. Bosgar will review financial results for 2023. Following the company's prepared remarks, Dr. Shepard will join the call to help address questions from 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 actual results to differ materially from these statements. Any such statements should be considered in conjunction with the cautionary statements and our press releases, and risk factors discussed in our filings with the SEC, including our quarterly reports on Form 10Q and annual report on Form 10K, and cautionary statements made during this call. Please assume no obligation to update any of these forward-looking statements or information. Now, I'd like to turn the call over to Dr. Beto Addo. Frank?

Thank you, Tom, and good morning, everyone. I am pleased to be speaking with all of you today. and to be joined by two new members of the PDS Biotech leadership team. Lars Wilsgat joined us last November as Chief Financial Officer. He is an experienced CFO with an impressive track record of guiding biotech companies to create strategic growth. We welcome his insights as well as his financial expertise and oversight as we continue to mature our business and advance our clinical programs. In January of 2024, we also announced the appointment of Dr. Kirk Shepherd. Kirk is a distinguished board-certified medical oncologist and hematologist with more than 30 years of experience in the pharmaceutical industry. Most recently, Kirk was chief medical officer Senior Vice President and Head of the Global Medical Affairs Oncology Business Group at ESAI. We are particularly pleased to have Kirk on board as his wealth of oncology and clinical expertise will be invaluable as we begin to execute the updated clinical development strategy we will be discussing today. As Tom mentioned, Lars will walk you through our financial results for 2023 later on the call. and Kirk will be available to take questions during the Q&A session. So let's begin. Our fourth quarter of 2023 and recent weeks have been a busy and productive period for PDS Biotech, during which we made significant advancements with our PDS01-ADC, our IL-12 fused antibody drug conjugate clinical programs, as well as our PDS-01-01 Phase II programs. Over this period, compelling data from several Phase II trials became available. This includes long-term survival data from the National Cancer Institute-led triple combination trial of PDS-01-ADC in combination with Versamune HPV, formerly known as PDS-01-01, and an investigational immune checkpoint inhibitor, or ICI. We also obtained data from our own Versatile 002 study of Versimmune HPV and Keytruda. Collectively, these data have provided us with clarity regarding how our drug platform technology works in advanced cancer and have informed the strategic decision we announced today to advance this triple combination of Versamune HPV, PDS01-ADC, and Keytruda in recurrent and or metastatic head and neck cancer, also referred to as head and neck squamous cell carcinoma, or HNSCC. This program will be our top clinical development priority in place of the previously planned Versatile 003 trial. This decision enables us to focus our resources on a regimen which we believe has the highest potential benefit to patients with head and neck cancer and the potential to drive shareholder value. On today's call, we will walk you through the data that has driven this decision, discuss the careful vetting we've undertaken to confirm our approach, and outline the advanced preparations on trial design and regulatory engagement we've already begun. To set the stage, I'll first review the critical limitations that remain in the use of immunotherapies to treat solid tumors. First, the innate or acquired resistance these tumors have to immunotherapies, including immune checkpoint inhibitors, or ICIs, and CART T cell approaches. These approaches all rely on activating T cells to attack the cancer. They therefore attack the cancer from the outside. However, most advanced solid tumors house their protection against the immune system in their inner core. These tumors can therefore prevent T cells from recognizing or infiltrating the tumor. In addition, these tumors may be able to inactivate any infiltrating T cells due to the presence of suppressive cytokines or inhibitory factors within the tumor. The second important limitation is that current immunotherapies have not demonstrated the ability to generate the right type and quantity of effective tumor infiltrating and tumor killing T cells, unlike what we have demonstrated with our Versimune platform to date. Recent long-term survival results and clinical data provide clarity on the dual mechanism of action of combining PDS01-ADC and Versimune, and its potential to overcome most critical immuno-oncology limitations. The insights into the PDS01ADC mechanism of action provided by this recent data clarify the potential of this drug therapy in combination with versimune HPV and an immune checkpoint inhibitor. PDS01ADC utilizes an antibody that binds to DNA found in the inner core of the tumor and therefore delivers the IL-12 into the internal compartment of the tumor. The IL-12 once within the tumor limits the presence of inhibitory factors within the tumor, thereby weakening the tumor's defenses against the immune system. Versaimmune HPV simultaneously generates a powerful T cell attack on the exposed or less protected tumor, resulting in compelling anti-tumor responses, which we will discuss shortly. The data show that with this combination, the mechanism uniquely acts on both the inside and outside of the tumor. Data was announced last November from the Phase II National Cancer Institute-led triple combination trial for the treatment of recurrent and or metastatic HPV16-positive, ICI-naive, and ICI-resistant cancers. This included head and neck cancer among other tumor types and provided proof of concept of the mechanism of action and support for prioritizing the triple combination. In the ICI resistance group, the 12-month overall survival rate was 72%, and the median overall survival was approximately 20 months. With current approaches, the 12-month overall survival rate in HPV-positive ICI-resistant cancer is approximately 30%, and median overall survival is only 3.4 months. A 63% overall response rate, or ORR, was observed in patients with the optimal dose of PDS01-ADC. Published data to date suggests ORR of less than 20% in ICI-resistant HPV-positive head and neck cancer. In the ICI-naive group, 75% of patients remain alive at 36 months, and therefore, the median overall survival was not reached. With immune checkpoint inhibitors, published results show a 36-month survival rate of approximately 20%. Overall response rate of 75% was seen in patients treated with the triple combination with a complete response rate of 38%. Published ORR of less than 40% is seen with immunotherapeutic agents. With the triple combination, responses were seen in all HPV-positive tumor types. These data are further supported by our robust clinical data set in over 430 patients treated with either versimune HPV or PDS01-ADC or the combination, including over 110 head and neck cancer patients to date. Importantly, with respect to safety, we have seen acceptable tolerability in over 300 patients treated with PDS01-ADC and in over 170 patients with Versamune HPV to date. Additionally, the National Cancer Institute has completed a detailed dose optimization study for PDS01-ADC based on safety and clinical response. which is a critical consideration for the FDA. This large database of patients provides a robust clinical data set that validates the potential efficacy and safety of our platforms, which we believe supports our decision to prioritize our Versamune PDS01-ADC platform in combination with Keytruda. Based on the totality of data generated to date from Versatile 002 and the National Cancer Institute-led triple combination study, our triple combination trial to be progressed will therefore consist of Versimune HPV, PDS01-ADC, and Keytruda. We engaged the FDA regarding our decision. and the FDA has provided clear guidance on clinical study design and regulatory pathway for the triple combination. We also engaged with top US and EU key opinion leaders to confirm interest in the triple combination and participation in a clinical trial. We are pleased to announce that Dr. Katherine Price of Mayo Clinic who is also an investigator on the VIRST-L002 trial, will be the lead investigator in the planned pivotal trial of the triple combination. We are also conducting rigorous evaluation of the competitive landscape in both ICI-naive and ICI-resistant head and neck cancer. This careful research takes time, but we are taking the necessary steps to ensure that our decision is in the best interest of patients and our shareholders. We intend to move strategically and aggressively to advance the triple combination into a pivotal trial. By initially addressing the rapidly growing unmet medical need in recurrent metastatic HPV 16 positive head and neck cancer, We strongly believe that this approach has the potential to rapidly establish the combination of PDS01-ADC and Versamune as a transformative oncology platform. The data suggest that the triple combination may result in a significant improvement in overall survival rates for patients who currently lack an effective treatment option. We are deeply grateful to our patients who participate in our trials and to our collaborators who continue to show immense confidence in our platforms and who have been instrumental in working with PDS Biotech to achieve what we now believe are potential significant advances in cancer treatment. With that, I will turn it over to Lars for a review of our financial results. Lars?