PDS Biotechnology Corporation

Hello, and welcome to the PDS Biotechnology first quarter 2022 earnings call and webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Gabby DeGravina. Please go ahead.

Good morning, and welcome to PDS Biotechnology's first quarter 2022 earnings conference call in audio webcast. With me today from the company are Dr. Frank Feduado, Chief Executive Officer, Dr. Lauren Z. 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 March 31st, 2022. We encourage everyone to read the press release as well as PDS Biotech's report on Form 10-Q, which was filed with the SEC earlier this morning. The company's press release is available on the PDS website at pdsbiotech.com, and the 10-Q should be posted later today. 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. These statements are subject to risk and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found on 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. As you can see, we're using a different format for the earnings call today. relying on slides to help summarize programs and milestones, and aiming to streamline the presentation of background information and updates. We know your time is a precious commodity, and we want to leave as much time as possible for Q&A. Your feedback on this new structure would be welcome. With that, I would now like to turn the call over to Frank. Frank?

Thank you, Gabby, and thanks to all of you for joining us this morning. Before we get into the details of our recent achievements and financial results, we thought it would be helpful to give a brief review of our platforms and pipeline to put our accomplishments into context. We are also providing some visuals to aid our discussion. For those of you who may be new to the story, and as a quick refresher, our pipeline is built on two proprietary T-cell activating platforms, Versamune on which an expanding pipeline of clinical and preclinical molecularly targeted immuno-oncology candidates are based, and InfectiMule, on which our advancing preclinical infectious disease pipeline is based. The VersiMule platform allows us to administer tumor-specific proteins by subcutaneous injection, resulting in powerful CD8 killer T-cell responses against the cancer. The infectimmune technology is administered predominantly by intramuscular injection and results in both pathogen-specific T-cell and antibody responses. PDS Biotech is developing multiple molecularly targeted cancer immunotherapy candidates, such as our lead product, PDS-0101. PDS-0101 has been demonstrated in ongoing studies to target cancers that express or contain HPV and is agnostic to the anatomic location of the cancer. These Versamune-based immunotherapies therefore have the potential to treat a broad range of cancer types. With our Versamune platform, we seek to lead a transformation in the treatment of cancer towards not only more effective, but also potentially safer therapies. we believe that we are well on our way to doing so. With our infectimmune technology, we seek to lead the development of more broadly protective vaccines, such as seen in the preclinical results reported with our universal flu vaccine. Here, we provide a broad overview of ongoing studies with our lead Versamune-based candidate, PDS0101, which is being evaluated in four phase two clinical trials as a combination treatment in advanced and refractory cancers and also in locally advanced cancer. In early stage cancer, PDS-0101 is also being evaluated as a monotherapy. PDS-0101 is a molecularly targeted immunotherapy that we're studying across the full spectrum of HPV-related cancers. By this, I mean that we are studying PDS0101 in all types of HPV-associated cancers, including anal, cervical, head and neck, penile, vaginal, and vulva cancers. Secondly, we are studying these cancers at all stages of the disease, from early-stage cancer in our neoadjuvant trial led by Mayo Clinic, to advanced checkpoint inhibitory refractory cancer in our National Cancer Institute-led trial. We estimate this could create an aggregate market potential of $5 to $6 billion in the United States and Europe for PDS0101. We are conducting these trials in collaboration with some of the most renowned institutions in the field, the National Cancer Institute, Merck, MD Anderson Cancer Center, and the Mayo Clinic. These strategic relationships have enabled PDS Biotech to achieve our goal of broadly covering the HPV cancer space. These relationships have provided multiple additional benefits to PDS Biotech. Not only have they enhanced our expertise in the space, but we believe they have facilitated enrollment in the clinical trial, and importantly, Through cost-sharing agreements, we have mitigated much of the financial burden of rapidly advancing our clinical studies. We are very excited that data from the first two studies listed here, our National Cancer Institute-led triple combination trial and our versatile 002 trial, will both be presented at this year's American Society of Clinical Oncology Annual Meeting, ASCEL, occurring from June 3rd through the 7th. We believe this is a real testament to the quality of work being done by our team and our partners, and we are very much looking forward to sharing these efficacy and safety results publicly. Do note that accepted abstracts are scheduled to be published on May the 26th. On Tuesday, June 7th at 8 a.m., After our presentations, we plan to host a conference call to further discuss the presented data from both trials. We'll issue a press release to announce this event. Turning to trial updates. Let's first review our triple combination study. In this trial, we are evaluating PDS0101 in combination with Bintrop sub-alpha, a bifunctional checkpoint inhibitor, and M9241, also known as NHS IL-12, two investigational immune-modulating candidates owned by Merck KGAA. By combining three components that activate the immune system by complementary anti-tumor mechanisms, our goal is to generate cancer-targeting killer T cells while successfully overcoming the immunosuppressive tumor environment. The triple combination is being evaluated across the range of HPV positive, advanced, relapsed, and refractory cancers that are well documented to be extremely difficult to treat and for which more effective therapies are desperately needed. The data from this trial to be presented at ASCO will be a continuation of the study and data that was presented at ASCO last year in both checkpoint inhibitor-naive and checkpoint inhibitor refractory patients. We expect an update on how the patients whose data was presented have fared over the last year. Essentially, how durable was the anti-cancer immune response and what fraction of the patients remain alive. Improving overall survival is one of the most important goals of cancer treatment. Secondly, what do the overall responses, including the more recently enrolled patients, look like? We anticipate that in addition to the solid preclinical data demonstrating the key contribution of each of the three agents towards the observed strong anti-tumor results, that the FDA may expect some demonstration of the clinical contribution of each of the agents in the combination. the role of PDS-0101 was very clearly demonstrated in the early data. To study the contribution of NHSIL-12, the National Cancer Institute is evaluating high and low doses of the drug, and we expect that some of this data may also be presented at ASCO. The preliminary efficacy data appears to support the Versamune platform's potential unique ability to aid in the recruitment training, and activation of large numbers of critical cancer-attacking killer T cells in vivo, even in very ill patients. We plan in the near future to initiate discussions with the FDA to align on the registrational path. Now turning to our Versatile 002 Phase 2 trial, which is studying PDS-0101 in combination with Merck and Co's checkpoint inhibitor Keytruda, or pembrolizumab in patients with HPV-16 positive, metastatic, and or recurrent head and neck cancer. As with the triple combination trial, this trial has two study groups, checkpoint naive patients and checkpoint refractory patients. In this trial, PDS Biotech is seeking to improve clinical benefit over that seen with Keytruda monotherapy. In addition to improved tumor shrinkage and overall survival, we believe that a significant treatment advantage will be achieved if enhanced clinical benefit is attained without compounding or increasing the toxicity profile over what has been reported with Keytruda monotherapy. In February of this year, promising preliminary safety data were presented at the Multidisciplinary Head and Neck Cancer Symposium. None of the first 18 patients showed any treatment-related grade 3 or higher toxicities. This is extremely unusual for any cancer therapy, and particularly for a combination therapy. To put the safety profile in perspective, I'll quickly refer to a news article in March out of the Hollings Cancer Center at the Medical University of South Carolina, one of the top head and neck cancer centers in the country. The principal investigator on our study, Dr. Kaczmar, had enrolled his first patient onto the study in August of 2021. The patient had a tumor mass of about eight centimeters and signs of spread. By March of 2022, the tumor had shrunk to two centimeters and the patient was reported to have continued to have a high quality of life through treatment. To quote Dr. Kaczmar, The treatments involved in this trial so far have been very tolerable, which is nice because sometimes investigative treatments can produce some side effects. The main side effects of the study treatment we've seen are some pain and redness around the injection site and fatigue. Do note that we have reported a small patient size of 18. However, If this combination of efficacy and safety continues to be seen in a significant number of patients, this approach of using the Versamune T-cell activating technology could be transformative in cancer treatment. We look forward to presenting detailed efficacy data from the first arm of the Versamune 002 trial at ASCO. Next, let's spend a minute or two on our preclinical Versamune-based oncology programs. PDS0103 targets Mucin 1 or MUC1. Given the presence of MUC1 across several solid tumors, we believe PDS0103 could have utility in the treatment of a broad range of cancers, including breast, ovarian, lung, and colon cancers, a very substantial global market. We previously discussed our positive preclinical data which demonstrated PDS-0103's ability to promote the induction of a large number of polyfunctional and highly potent MOC1-specific CD8 killer T cells. The PDS-0103 antigens have been successfully manufactured, and preliminary stability and immunogenicity testing of the new clinical-grade antigens is in progress by PDS Biotech. as is process development for manufacture of the PDS-0103 pharmaceutical product. Following a recent positive pre-IND meeting with the FDA, we continue to expect to file an IND for the program in the fourth quarter of 2022. We've also continued to make progress on our top program, PDS-0102. As you know, late last year, we in-license rights to the National Cancer Institute's proprietary T-cell receptor gamma-alternate reading frame protein tumor antigen, abbreviated TARP or TARP. Based on preliminary studies, we expect our candidate PDS0102 to facilitate the generation of TARP-specific CD8 killer T-cells and may have utility in the treatment of both solid and liquid tumors, including AML, prostate, and breast cancers. Manufacturing efforts here are ongoing. However, given all of our ongoing programs, we are not devoting significant resources to the TARP program and now expect clinical launch sometime in 2023. Lastly, before passing it over to Matt, I'd like to briefly discuss our infectimmune-based infectious disease preclinical pipeline. We believe that the key differentiating attributes of the infectimmune platform technology are strong indication or strong induction of virus or pathogens which can be leveraged to improve treatment and preventive options for several infectious diseases. In January of 2022, We announced preclinical data on our universal flu program sponsored by the NIAID, demonstrating potential of the infectimmune technology with computationally designed influenza proteins developed by the laboratory of Dr. Ted Ross at the University of Georgia. The universal seasonal flu vaccine, PDS0202, generated broadly protective anti-influenza immune responses across multiple strains of influenza. These data, as well as our COVID-19 data, has provided a unique opportunity to highlight infect-immune's potentially transformative utility in the development of more broadly effective and longer-lasting protective vaccines. We are hopeful that we could receive non-diluted financing from the NIH to progress our universal flu program into human clinical trials. Based on the highly promising data recently announced with the universal flu vaccine and the current focus of the NIAID on developing more effective flu vaccines, PDS Biotechnology has decided to strategically focus our near-term infectious disease activities to align with the interest of the NIAID to have a near-term focus on influenza. This will involve development of the universal seasonal flu vaccine and also potential development of a universal pandemic influenza vaccine based on similar computationally designed antigens as what has shown promise with infectamines. The company had outlicensed the COVID-19 vaccine PDS0203 to the Brazilian company Pharmacol specifically for development in Latin America. The progression of the Pharmacol development program was delayed in the fourth quarter of 2021. After review of the program by PDS, Biotech, and Pharmacol, the agreement with Pharmacol was extended through May 31, 2022, to provide additional time to Pharmacol to commence manufacturing and scale up of drug product for use in clinical trials. We have reevaluated the progress of the program, and as described above, have determined to strategically focus our near-term efforts on the development of the universal flu vaccine. The licensing agreement with Pharmacol will expire on May 31st, 2022. With that, I'll now turn it over to Matt for a review of our financial results. Matt?