PDS Biotechnology Corporation

in combination with Merck's Keytruda in recurrent or metastatic HPV-positive head and neck cancer. Safety data was presented at the multidisciplinary head and neck cancers symposium in February, and successful achievement of the preliminary efficacy milestone was also reported this February. Based on the successful attainment of the preliminary efficacy milestone in checkpoint inhibitor naive subjects, We similarly anticipate presenting more detailed efficacy results at an upcoming peer-reviewed conference in the coming months. For the MD Anderson-led trial evaluating PDS-0101 in combination with chemoradiotherapy in locally advanced cervical cancer, we still remain on track to provide data late in Q2 or early Q3. This quarter, we announced the initiation of a new PDS-0101 trial to be led by Mayo Clinic. This trial is studying the use of PDS-0101 with and without Keytruda as a potential neoadjuvant treatment for oral cancer and open to recruitment this month. We hope to see preliminary data in Q4 of this year or Q1 next year. Dr. Wood will take us through the more detailed clinical updates. The Mayo Clinic was selected to replace the previously projected PDS0102 trial. This decision was strategic to capitalize on the commercial opportunity to expand the target market for PDS0101 to early stage disease. With the reported rapid increases in the incidence of HPV-associated oral cancer, there is a growing number of early stage cancer patients who may benefit from treatment with an immunotherapy such as PDS-0101. It is noteworthy that all of our clinical programs are partnered with distinguished leaders in oncology and immuno-oncology, which we believe provides strong validation of our science and approach. In addition, these relationships through cost-sharing agreements have also significantly mitigated the financial burden of advancing our expanding clinical pipeline. PDS0102 and PDS0103 have completed preclinical development. Our three immunotherapies currently in development, PDS0101, PDS0102, and PDS0103, present a multi-billion dollar opportunity. PDS0101 addresses an approximately $5 to $6 billion US market. PDS0102 addresses cancers containing a protein we call TARP, T-A-R-P, including prostate cancer, breast cancer, and acute myeloid leukemia. It is estimated that there are over 300,000 new cases of these TARP-associated cancers in the United States every year. We believe the majority of these patients may benefit from PDS0102 immunotherapy. This is an approximately $45 billion addressable market. PDS0103 addresses cancers containing a protein called MUC1, M-U-C-1. These include colon, breast, ovarian, and lung cancers, another very significant market opportunity. We anticipate initiating clinical evaluation of PDS-0103 during the second half of this year. I will briefly discuss our infectious disease pipeline. These products are based on our Infectimmune platform, which is designed to induce broadly acting neutralizing antibodies in addition to T cells. The most progressed of these programs are PDS0202, which is a universal flu vaccine, and PDS0203, a second generation COVID-19 vaccine. PDS0201, our tuberculosis vaccine, was deprioritized in 2020 in order to develop the COVID-19 vaccine. PDS0202 combines infectimmune with novel computationally designed proteins that were developed by Dr. Ted Ross, a world-renowned flu expert. This program is funded by the National Institutes of Allergy and Infectious Diseases, NIAID. With PDS0202, our goal is to develop a vaccine that, unlike the current flu vaccines, may provide robust protection against multiple strains of the flu. Impressive data demonstrating the potential of our infectimmune technology to induce high levels of broadly protective neutralizing antibodies was presented. This led to effective protection against infection and sickness. Dr. Wood will provide additional details on the study and results. PDS0203, our second generation COVID-19 vaccine, is being developed under license from PDS Biotech by the Brazilian company Pharmacor for Latin America. We expect that a strong neutralizing antibody and CD8 T-cell activating vaccine may produce more durable or longer protection against multiple strains of the virus. Pharmacor is fully responsible for product development and is currently performing manufacturing development and scale-up. Clinical development is to be funded by the government of Brazil. We will provide updates as they become available. As part of our goal of successfully commercializing our pipeline product, We also completed a number of licensing transactions and continued to build partnerships, not only securing intellectual property for our expanding pipeline, but also enhancing our relationships with global organizations. We announced the licensing of the top proteins expressed in prostate cancer, breast cancer, and acute myeloid leukemia from the National Cancer Institute in Q4 of 2021. In addition, we announced an agreement to license the computationally optimized broadly reactive antigens, also called COBRA, used in our universal influenza vaccine, PDS0202, from the University of Georgia. And lastly, as you can see here, we strengthened our corporate leadership, adding distinguished immuno-oncology experts to our scientific advisory board and welcoming Matt Hill as our chief financial officer. We also reported that the company was added to the Russell Microcap Index in late 2021. And importantly, we added more than $52 million to our balance sheet, significantly extending our cash runway and ability to continue to advance our drug development programs. As most of you already know, our oncology and infectious disease pipelines are based on two proprietary platforms. Versamune and Infectimmune, respectively. With our Versamune platform, we are developing a new class of molecularly targeted immunotherapies, which have demonstrated excellent potential to induce in vivo or within our bodies tumor-attacking killer T-cells, also known as CD8 T-cells. Our ability to achieve this, we believe, presents strong potential to overcome one of the biggest limitations of immune oncology. The ability to induce T cells in vivo is neither novel nor unique. What is however unique about Versimune is its ability to, first of all, induce the right type of killer T cells, secondly, to promote powerful killing potency of the killer T cells, and thirdly, to generate large numbers of these induced potent killer T, the right quantity and the right potency. Versamune also induces memory T cell responses, which are important in generating prolonged clinical efficacy. Versamune's method of T cell activation has presented early indications of potential for a combination of potency and safety. With that introduction, I will now hand over to Dr. Lauren Wood, PDS Biotech's Chief Medical Officer, to provide additional details on our ongoing clinical studies. Lauren?

Thanks, Frank, and thanks to all for joining us today. Our most progressed clinical program is the National Cancer Institute-sponsored Phase II trial studying PDS-0101 in combination with both Bintra-FUSP-alpha, or Bintra for short, and M9241, also known as NHS IL-12, two investigational immune-modulating candidates owned by Merck KGAA. The study is investigating the combination in patients with recurrent or metastatic HPV-positive cancers, including anal, cervical, head and neck, penile, vaginal, and vulvar cancers who have failed prior treatment. One cohort is evaluating patients who have not been treated with checkpoint inhibitors and have not responded to at least one standard of care therapy. These are CPI-naive patients. Almost all patients in this cohort have failed both chemotherapy and radiation treatments and would be moving on to checkpoint inhibitor therapy as a potential treatment option. The second cohort is evaluating the triple combination as a third-line treatment in patients with recurrent or metastatic HPV-positive cancers who have failed checkpoint inhibitor therapy. These are the CPI refractory patients. To date, the study has recruited 45 patients. As of December 31st, 2021, 30 patients who are HPV-16 positive had at least one evaluation. There's currently about a three-to-one ratio of CPI refractory patients to CPI-naive patients enrolled in the trial. This means that we have a significantly larger number of patients who have failed all of the treatment options being studied. As reported at ASCO in 2021 by the NCI, CPI naive patients historically have a median survival of seven to 11 months on CPI monotherapy. CPI refractory patients who have failed all three treatment approaches have a historical median survival of only three to four months. As of December 31st, 2021, the median overall survival of these patients on this study exceeds 12 months and counting. These results are extremely promising, especially given the limited treatment options for the majority of this population and presents a severe unmet medical need. On treatment with the triple combination, almost 70% of patients, including those who are CPI-naive and CPI-refractory, experience tumor shrinkage. These preliminary results may suggest that these refractory cancer patients may not only be living longer, but the majority also appear to be experiencing tumor shrinkage. In this study, an important observation was made with the patients whose tumors were not positive for HPV16, the HPV16 negative patients. Although these patients appear to have a potential survival benefit, no tumor shrinkage was observed in this population because they do not express the HPV16 protein target for PDSO101. The contrasting tumor shrinkage seen in HPV16 positive patients is an important result. because it strongly suggests that PDS0101 is effectively training killer T cells to specifically recognize and kill tumors in patients that express HPV16 proteins. The clinical results obtained in anal, cervical, head and neck, vaginal and vulvar cancers suggest that the preliminary efficacy that's been observed is independent of the type of cancer or its anatomic location. so long as the cancer meets the target molecular profile of HPV16 expression. We are hopeful that pending the updated results of the study, that PDS, NCI, and Merck KGAA will initiate discussions with the FDA on the expected clinical and regulatory strategy for a pivotal phase three trial and eventual regulatory approval pathway for the combination. The VERSATILE-002 Phase II clinical trial is studying PDS-0101 in combination with US Merck's checkpoint inhibitor Keytruda, also known as pembrolizumab, in patients with HPV-16 positive recurrent and or metastatic head and neck cancer. The two study groups include checkpoint-naive patients and checkpoint-refractory patients. This past year, we successfully achieved the first safety benchmark in the checkpoint inhibitor naive arm of the trial, which allowed the study to advance to full enrollment. We have since announced updated safety data from 18 patients in the CPI naive group. These data were presented at the multidisciplinary head and neck cancer symposium in February and demonstrated that the combination treatment was well tolerated without evidence of enhanced or significant toxicity. Accrual has progressed to stage two for the CPI-naive cohort and is ongoing in stage one for the CPI-refractory cohort. More recently, we released preliminary efficacy data from this same group of 18 CPI-naive patients. The Simon two-stage clinical trial design requires the achievement of an objective response as measured by radiographic tumor responses according to Resist 1.1. This response requires a tumor reduction of 30% or more that is confirmed by two separate measurements among at least four or more of the first 17 patients in the CPI-naive arm. Achievement of this milestone allowed for progression to full enrollment of the CPI-naive cohort with a target total of 54 patients. We expect that more mature results will be presented at a medical conference late this year. In parallel, we are enrolling into the CPI refractory cohort of the trial. This cohort is similarly being evaluated using assignment two stage design. In this cohort, we have to achieve an objective response in two out of the first 21 patients to proceed to full enrollment of the cohort with a targeted total of 41 patients. Our third PDS-0101 trial is the ImmunoServe trial, a phase two investigator-initiated trial sponsored by MD Anderson to evaluate PDS-0101 in combination with chemoradiotherapy in patients with locally advanced cervical cancer. As we briefly discussed on our last call, One of the more interesting aspects of this trial is that we'll be collecting both systemic and tumor-specific biomarker data. This may help further elucidate understanding the immune response to the verse immune-based immunotherapies and how early biomarkers may correlate with clinical response. Preliminary results from ImmunoServe are still anticipated in mid-2022. If this trial is successful, it could support further investigation of diverse immune-based immunotherapies with chemotherapy or chemoradiotherapy to treat multiple cancers. The fourth Phase II trial of PDS-0101 is being led by the Mayo Clinic. This trial is evaluating PDS-0101 alone or PDS-0101 with Keytruda in the neoadjuvant treatment of patients with oropharyngeal cancer or prior to transoral robotic surgery. We believe this study will provide invaluable data regarding potential expansion of the versus immune-based immunotherapies into early stage cancer. This trial is now open to enrolling patients. Lastly, before passing it over to Matt, I'd like to briefly focus on our infect immune-based infectious disease preclinical pipeline. Our universal flu vaccine program, PDS0202, is being developed in partnership with the NIAID Division of the NIH. This vaccine is being designed to protect against multiple strains of the flu and combines our infectimmune technology with novel computationally optimized broadly reactive antigens known as COBRA. that have been designed by renowned influenza expert at the University of Georgia, Dr. Ted Ross. The antigens were selected following successful preclinical development work completed under a grant from the NIAID's Collaborative Influenza Vaccine Innovation Centers, or CIVIX program, to progress the development of PDS0202. Preclinical studies demonstrated the ability of PDS-0202 to generate high levels of flu-specific neutralizing antibodies, CD4 helper, and CD8 killer T cells, as well as long-acting memory T cells to potentially provide broad and long-term protection against multiple influenza strains. What has been demonstrated in preclinical studies that without infectimmune, there is ineffective neutralization of any viral strain. The preclinical data suggests that with infectimmune, the effective delivery of flu proteins activate the critical immune signals necessary to generate powerful neutralizing antibody responses to all of the flu strains that were tested. This is a very important and highly encouraging result. It was also important to study the ability of PDS0202 to protect from influenza infection. In standardized influenza challenge studies, a control group were administered a vaccine that had no flu protein. When they were challenged with the H1N1 flu strain, they all died. The second group of mice received a dose of the novel flu proteins, but without infectimmune. All animals got sick. and only 30% survived. However, in the mice vaccinated with PDS-0202, 100% of the animals were completely protected and stayed healthy. This was the case even using a low dose of PDS-0202, which contains 25-fold less flu protein. These studies strongly suggest that a universal flu vaccine is possible PDS Biotech hopes to progress the PDS-0202 vaccine into clinical development in collaboration with the Civics Program Network. The data from these preclinical studies are being prepared for submission to a peer-reviewed journal for publication. With that, I'll now turn it over to Matt for a review of our financial results. Matt?

Thank you, Lauren. First, I want to thank our shareholders for your patience with the rescheduling of our earnings call. Our auditors needed more time to complete their procedures and in order to give them that time, it made sense to reschedule this call to today. With that, let's move to the financial discussion. For the year ended December 31, 2021, the net loss was approximately $16.9 million or 66 cents per basic and diluted share compared to a net loss of approximately 14.8 million or 89 cents per basic and diluted share for the year ended December 31, 2020. As of December 31, 2021, PDS Biotech had 28.4 million common shares outstanding and 31.8 million common shares outstanding on a fully diluted basis. For the year ended December 31, 2021, research and development expenses increased to approximately $11.3 million compared to approximately $7.9 million for the year ended December 31, 2020. The increase of $3.4 million was primarily attributable to an increase in regulatory and clinical costs of $2.6 million, non-cash stock-based compensation of $1.1 million, personnel costs of $0.4 million, partially offset by an overall decrease in manufacturing and facility costs of $0.7 million. For the year ended December 31, 2021, general and administrative expenses increased to approximately $10.2 million compared to approximately $7 million for the year ended December 31, 2020. The $3.2 million increase was primarily attributable to an increase in personnel costs of $1 million, non-cash stock-based compensation of $2.5 million, and facility costs of $.1 million. partially offset by a decrease in professional fees of $0.4 million. Total operating expenses for the year ended December 31, 2021 were approximately $21.4 million, an increase of approximately 44% compared to a total operating expenses of approximately $14.9 million for the year ended December 31, 2020. The company's cash balance as of December 31, 2021 was $65.2 million. Based on the company's available cash resources and cash flow projections, the company believes this balance is sufficient to fund the company operations and research and development programs through the end of 2023. With that, why don't we open it up to questions? Operator?