PDS Biotechnology Corporation

Greetings. Welcome to PDS Biotechnology's third quarter 2021 earnings column webcast. At this time, all participants are in a listen-only mode. A brief 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 conference is being recorded. At this time, I'll now turn the conference over to Deanne Randolph, Vice President of Commercial Development. Deanne, you may now begin.

Good morning. And welcome to PDS Biotechnology's third quarter 2021 earnings conference call and audio webcast. With me today are Dr. Frank Betu-Otto, Chief Executive Officer, Dr. Lauren B. 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 30, 2021. We encourage everyone to read the press release as well as PDS Biotech's quarterly report on Form 10-Q, which was filed with the SEC earlier this morning. The company's press release is available on PDS Biotech's website at pdsbiotech.com, and the quarterly report will be posted later today. In addition, this conference call is being webcast through the company's website and will be archived there for future reference. Before we begin, I would like to caution listeners that comments made by management during this conference call will include forward-looking statements within the meaning of federal securities laws, including the state harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve material risks and uncertainty, and the company's actual results may differ materially. For a discussion of these risk factors, including, among others, the risks related to COVID-19, the impact such pandemic may have on the company's business operations, financial operations, and results of operations, and the company's ability to respond to the related challenges, including those noted in this morning's press release, please refer to PDS Biotech's SEC filings. Investors, potential investors, and other listeners are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. Please note that the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, November 10, 2021. Except as required by law, the company undertakes no obligation to revise or update any statement to reflect events or circumstances that take place after the date of this call. Following today's prepared remarks, we will open the discussion for a question and answer session. With that, I would now like to turn the call over to Dr. Frank Beruado.

Thank you, Deanne, and thanks to everyone on the call today. Last year at PDS Biotech, we initiated execution of our oncology clinical strategy and outlined key milestones that we have planned to achieve in 2021 and 2022. PDS Biotech is still on track to achieve each of these milestones on schedule, with added progression of pipeline programs. 2021 has been an extraordinary year for PDS Biotech. We shared extremely promising interim results of PDS 0101 from ongoing clinical trials, and this quarter have continued to progress our pipeline programs towards commercialization of what we believe are transformative treatments for cancer. As we begin to see the positive human impact versamine-based treatments are having on terminally ill patients who previously had very few, if any, options, our team at PDS Biotech is highly encouraged. We continue our strong relationship with the National Cancer Institute. A key goal of the National Cancer Institute is to make and to promote significant advancements in the treatment of cancer. Last quarter, interim data for the National Cancer Institute-led Phase II study of a novel triple combination, including our lead candidate, PDS0101, was reported at the American Society of Clinical Oncology, also known as ASCO, annual meeting. This clinical strategy is based on an immunotherapeutic combination targeting a specific molecular marker HPV16 present in six different cancers. This represents a paradigm shift in cancer treatment as we evolve from treating tumors by location to treatment based on molecular profiles. The strength of the data across all HPV16 tumor types is extraordinary in immuno-oncology. One arm of this ongoing clinical trial is evaluating the novel PDS-0101-based combination in patients with anal cancer, cervical cancer, head and neck cancer, penile cancer, vaginal and vulva cancers, who have failed at least one standard of care treatment. In a second arm, the trial is studying the combination in patients with the same six cancers who have failed one or more standard of care therapies, including checkpoint inhibitor therapy. The interim data from both arms of the study strengthens the evidence of the Versamine platform's potential ability to recruit, train, and activate large numbers of critical cancer-attacking killer T cells, even in very ill patients, and may overcome a key limitation of cancer immunotherapy. The strong proof-of-concept data suggests potential utility of Versimune in the development of molecularly targeted cancer immunotherapies that are agnostic to the location of the cancer in the body and have the potential therapeutic efficacy across multiple types of cancer. During the third quarter, we significantly progressed several pipeline products towards clinical development. We are focused on executing our PDS-0101 Phase II trials and rapidly progressing our pipeline products into clinical development in order to understand the potential of our molecularly targeted immunotherapies in treating a broad range of cancers. Let's begin with the PDS-Biotech-initiated Versatile 002 trial conducted in collaboration with Merck. The versatile 002 study is designed to evaluate PDS0101 in combination with Keytruda, also known as Pembrolizumab, in the treatment of advanced HPV16-associated head and neck cancer. This September, we announced successful recruitment of the initial cohort of checkpoint inhibitor-naive patients for first-line treatment of recurrent or metastatic head and neck cancer. We also announced the achievement of the trial's preliminary safety benchmark, demonstrating no dose-limiting toxicities. This positive safety data strengthens confidence in PDS0101's potential to address a significant unmet medical need in the treatment of advanced HPV16-associated head and neck cancer. as well as other HPV-associated cancers. We also completed stage one enrollment of the Simon two-stage design for this cohort of the study. In addition to this, we initiated accrual into the checkpoint inhibitor refractory arm, which addresses second-line treatment of recurrent or metastatic head and neck cancer. Moving on to PDS0102. TDS-0102 combines diverse immune platform technology with a proprietary T-cell receptor gamma-alternate reading frame protein, TARP, also known as TARP. This is a tumor-associated protein identified by the National Cancer Institute. This week, we announced a licensing agreement with the National Cancer Institute for intellectual property related to their proprietary TARP protein. It is important to note that TARP has already been studied by the National Cancer Institute in men with prostate cancer and been shown to be safe and recognized by the immune system. Administration of the National Cancer Institute's TARP-based immunotherapy was associated with a significant slowing of tumor growth rates in the published clinical trial. Based on our preclinical results, We are excited about the potential of PDS0102 as a second molecularly targeted immunotherapy addressing TARP-associated cancers, including prostate cancer, breast cancer, and acute myeloid leukemia, or AML. We are now preparing to move into the clinic with our next two oncology products. PDS0102, which we just discussed, and PDS-0103, which targets the Mach 1 protein present in multiple solid tumors. We have requested a pre-IND meeting with the FDA for PDS-0103. The Versimune technology is propelling our molecularly targeted immunotherapies into a broad range of cancers. It is the potential of Versimune that allows for six different cancers with the same molecular profile to be studied in just one trial, as is being done in the National Cancer Institute-led PDS0101 trial. We believe our approach will lead to quicker and broader medical and commercial impact. Now moving to our infectious disease pipeline. Based on exciting preclinical data, We announced last week that PDS Biotech has obtained the option to license the novel computationally optimized broadly reactive antigens, or COBRA, designed by renowned influenza expert Dr. Ted Ross at the University of Georgia. Dr. Ross leads one of the NIAID's collaborative influenza vaccine innovation centers, CIVICS, based at EUGA. These novel proteins are being used in the development of PDS0202, our universal flu vaccine candidate. The flu has touched all of us in some way, resulting in hundreds of millions of illnesses and hundreds of thousands of deaths every year worldwide. A versimune-based universal flu vaccine could provide significantly enhanced protection and may eliminate the need to manufacture a new seasonal flu vaccine each year. Compared to the current antibody-focused flu vaccines, PDS0202 could present a huge advancement in the development of a new generation of more broadly active antibody and T cell influenza vaccines. Preclinical work on PDS0202 is almost complete. and the data has been very encouraging. Lauren will walk through the top line data. We are finalizing formulation work and are exploring funding opportunities to move the product into human clinical testing. For our second generation COVID-19 vaccine, PDS0203, we have completed a strategic review of the Pharmacore program, and have aligned on key manufacturing and regulatory milestones that must be met in the short term. Pharmacor has made some progress on the protein manufacturing and supply issues that have delayed their program. Based on this progress and our program review, we plan to extend our contract with Pharmacor, which is scheduled to end on November 30th by six months through May 2022. We will be closely monitoring their progress through this period. As a result of last quarter's capital raise, PDS Biotech has a strong cash position with funding to support planned activities over the next two years. PDS Biotech is very well positioned for the future. We are preparing for the next phase of growth and continued progression of our exciting product pipeline. We have several catalysts expected over the next three to 12 months as we advance our current studies and initiate new clinical trials. Last month, we welcomed Matt Hill as our new Chief Financial Officer. Matt has decades of experience as a financial leader in publicly traded life science companies. We are pleased to have Matt on board as we move into our next stage of growth. Now I'd like to pass the call to Dr. Lauren V. Wood, PDS Biotech's Chief Medical Officer, who will provide more comprehensive clinical updates on our development programs. Lauren?