PDS Biotechnology Corporation (PDSB) Earnings Call Transcript & Summary

Good afternoon, everyone, and thank you for joining the H.C. Wainwright 2021 Global Life Sciences Conference. My name is Michael Brotherton, I'm on the Corporate Access team at H.C. Wainwright. While we are virtual this year, we are confident we're going to be able to provide value to you with over 425 companies presenting at this conference as well as we hear interactions through one-on-one meetings. H.C. Wainwright is a full-service investment bank dedicated to providing corporate finance, strategic advisory and related services to public and private companies across multiple sectors and regions. We have a total of 18 publishing senior analysts and 493 companies covered across all sectors. Please visit hcwco.com for more information. From a logistics standpoint, please make sure to reference your virtual conference online portal that provides your individual links to your meetings and all presentations. Panels in all presentations are live and on-demand online for March 9 to 10. With that said, have a productive and enjoyable day, and I'd like to introduce our presenter. I'd like to welcome Frank Bedu-Addo, CEO of PDS Biotechnology Corporation.

Michael, thank you very much for the introduction. I would also like to thank the organizers of the H.C. Wainwright Global Life Sciences Virtual Conference for the opportunity to present PDS Biotechnology. Please note that this presentation contains forward-looking statements, and also please ensure that you are familiar with the risk factors associated with the company as filed with the SEC. So to date, the most significant limitation to effective cancer immunotherapy has been the lack of effective induction of tumor attacking killer T-cells, also known as CD8 T-cells that can be produced in vivo with both adequate potency and quantity. At PDS Biotech, we are developing a pipeline of cancer immunotherapies based on our proprietary, Versamune technology platform, that has been engineered and demonstrated to generate powerful in vivo CD8 T-cell responses. Other important characteristics of the Versamune-based cancer immunotherapies are the following: first, their ability to induce long-term memory CD8 T-cell responses resulting in long-term and durable efficacy; two, the unique combination of potency and safety without the systemic toxicities typical of immunotherapy; and thirdly, the versatility and ability to combine these immunotherapies with other types of cancer therapy, as we are currently doing in multiple ongoing Phase II human clinical trials. So PDS Biotechnology is a mid-clinical stage biopharmaceutical company, developing new treatments for cancer as well as novel T-cell activating vaccines for infectious diseases, both based on the company's proprietary Versamune platform technology. There are currently 3 Phase II human clinical trials in progress to study the company's lead immunotherapy, PDS0101. Now PDS has established key validating Phase II clinical partnerships with leading and well-respected oncology institutions, including Merck, the National Cancer Institute and MD Anderson Cancer Center. PDS Biotech is headquartered in Florham Park, New Jersey and our lab facilities in Princeton, New Jersey. The company has no debt and as of our last filing in September, a reported approximately $33.5 million in cash. We announced last month that our Phase II trial in advanced HPV-associated cancers in patients whose cancer had returned or spread after treatment had met its initial required threshold of 3 or more objective responses in the first 8 patients. Therefore, allowing recruitment of the full cohort of 45 patients. We are working with our 2 Brazilian partners as a consortium to develop and commercialize a novel Versamune-based T-cell activating COVID-19 vaccine in Latin America. The VERSATILE technology can be used with a broad array of tumor and infectious disease antigens, and is protected by several composition and application patents currently issued in several countries and valid through the mid-2030s. So on the slide, I showed the company's robust pipeline of oncology and infectious disease products. In each product, Versamune is combined with a different tumor or infectious disease protein antigen, which is specific to the particular cancer or infectious disease we're seeking to treat or to prevent. Our lead program, PDS0101, addresses various HPV-associated tumors and is being studied in 3 Phase II clinical trials. With our infectious disease programs, our universal flu vaccine studies are funded by a grant from the NIAID. And our COVID-19 vaccine program is partnered with Farmacore under adverse immune license from PDS and with Blanver as the commercialization partner, both in Brazil. So moving on to the technology. So the slide I show here is an important slide. Our Versamune platform is a T-cell activating technology. Now T-cells very significantly in type and potency. So it is quite important to know that not all T-cells are identical. Now in order to generate an effective curative immune response, it is critical to induce the right type of killer T-cell in the right quantity and also with adequate killing potency. Here, I show a preclinical HPV cancer study. This study is important because the tumor regression model is the most widely used animal HPV cancer model and has been used by all our competitors. Therefore, this allows us to compare directly our results with the leading competitors in the space. So on the left-hand side, we see a bar chart showing the number of killer T-cells induced by various clinical stage technologies. The dark green bars represent what we call polyfunctional CD8 T-cells, which are recognized to be the most potent type of killer T-cell. Now what this says is that the Versamune-based product induces not only a significantly higher quantity of T-cells, but also a much higher quality of killer T-cells. And so let's see the effect of this immunological characteristic of the Versamune technology on antitumor efficacy. So on the right-hand side, I show a tumor aggression plot with tumor size on the Y axis. In the untreated animals represented with the gray line, we see rapid and aggressive tumor growth. Now the black line shows the results when the HPV16 tumor-specific protein is administered. So here, we see that this protein is not effectively taken up by the immune system, nor is the right immunological signaling pathway activated, and the result is a complete lack of efficacy. The blue line is what we obtained using the clinical adjuvant GM-CSF, and this also represents the current state of the art and is representative of data reported by the leaders in the field. With multiple doses and immune response results, which leads to a slowing down of tumor growth, but the cancer continues to progress in the animals or patient live a little longer. That is the state of immunotherapy today. Now let's take a look at PDS0101 represented with the green line, which contains the same HPV16 tumor-associated protein now formulated with Versamune and administered in the exact same dose as before. After a single dose, what do we see? With Versamune, we see the unique ability to present the protein into the correct immunological processing and T-cell presentation pathways while also activating the right mechanisms to induce large numbers of high-quality tumor-killing T-cells. After 1 dose, we see by day 35, complete regression of the tumor. And this study has been replicated in hundreds of animals in different independent expert labs. Now what is interesting here also is the fact that after leaving these tumor free animals to go to 60 days and rechallenging them with the tumor cells, 100% of these animals are fully protected against tumor reestablishment. Now this means that not only have we induced a strong killer T-cell response, we've induced a powerful memory killer T-cell response that continues to protect against future disease. Now this characteristic of Versamune and its ability to generate powerful antiviral killer T-cells and memory T-cells also becomes very important when we talk about our novel class of infectious disease vaccines. This concept is currently being applied to our novel COVID-19 and universal flu vaccines. Now this slide here summarizes the key characteristics of a safe and effective immunotherapy, and clearly shows how differentiated the Versamune-based products are from other approaches in possessing each of the key and critical characteristics of unaffected immunotherapy. So I will now move on to our ongoing Phase II human clinical trials in advanced HPV-associated cancers, which include anal, cervical, head and neck, penile, vaginal and vulva cancers. In 2 of our 3 Phase II trials of PDS0101, we are taking advantage of the Versamune platform's unique combination of potency and safety to pursue a strategy of combining PDS0101 with FDA-approved standard of care already demonstrated to be safe and effective in the specific target indications. Now this approach is in order to deliver higher quality therapeutic options and outcomes to cancer patients. We believe that this approach of combination with standard of care significantly mitigate development risk and also presents significant commercialization upside. Now the furthest progress of the 3 PDS0101 trials is a National Cancer Institute-led Phase II trial, evaluating a novel triple combination of PDS0101 with 2 other clinical stage immunotherapies, bintrafusp alfa, which is also called M7824, a first-in-class bifunctional checkpoint inhibitor; and NHS-IL12, which is an antibody-conjugated cytokine. Both of these agents are owned by EMD Serono. Now this novel triple combination is based on the study's independently performed and published by the National Cancer Institute showing superior anti-tumor efficacy of the triple combination and is now being studied in patients with all types of HPV-associated cancers. So any patient with an advanced HPV-associated cancer such as anal, cervical, head and neck, penile, vaginal or vulva cancers who has failed prior treatment is eligible to enroll in this trial. I mentioned earlier that this trial had met its initial required threshold of 3 or more objective responses in the first 8 patients. Meaning that a minimum objective response rate of about 40% was required to perform the full trial. Now this result was achieved ahead of the full enrollment of the initial 8 patients and the trial has, therefore, been opened up to recruitment of the full 45 patients. Now the highest objective response rate in this specific population of patients who had failed prior treatments but have not yet been treated with a checkpoint inhibitor, meaning that they were checkpoint inhibitor naive is about 30%. And this result was achieved with M7824 and the study was published in October of 2020 in the Journal for Immunotherapeutic Cancer. So as a result of meeting or exceeding the 40% threshold, the trial has been opened up to full enrollment and is studying the effect of the triple combination in 2 distinct populations of advanced HPV-positive cancer patients. In group 1, the objective response rate is being evaluated in checkpoint inhibitor naive patients. So as I explained, these are patients who have failed prior treatments, but have not yet been treated with the checkpoint inhibitor. In group 2, the objective response rate is being evaluated in patients who have failed prior treatment, including checkpoint inhibitor therapy. These are checkpoint inhibitor refractory patients. We expect to present more mature data on this program next quarter. Now confirmation of enhanced efficacy with the novel triple combination could lead to expanded evaluation in several cancers with the 8 PDS pipeline products. On this slide, I summarize the collaboration with Merck combining PDS0101 with Merck's KEYTRUDA, which is standard of care in first-line treatment of recurrent or metastatic head and neck cancer. This is a single-arm open-label trial currently recruiting and enrolling approximately 100 patients. The goal of this trial is to determine if the combination provides improved efficacy over KEYTRUDA alone. If PDS0101 is clearly demonstrated to enhance the therapeutic benefit of checkpoint inhibitors, this could expand evaluation of the Versamune-based therapies in several cancer indications. Next is the MD Anderson-led trial combining PDS0101 with standard of care, chemoradiotherapy in the treatment locally advanced cervical cancer. Here again, the goal is to determine if the combination is safe and if it provides improved efficacy over CRT alone. This is also a single-arm open-label trial currently recruiting and enrolling approximately 35 patients. In this study, a demonstration of safety and enhanced efficacy could again lead to broad applications of Versamune-based immunotherapies in combination with chemotherapy or CRT to treat multiple cancers. I'll move on now to the commercial opportunities of our HPV cancer immunotherapy PDS0101. The PDS0101, as I mentioned, is designed to treat cancers caused by infection with the human papillomavirus. There are over 43,000 new incidences of these cancers every year in the United States alone. In many of these cancers, the incidences continue to grow. Head and neck cancer has recently been described as a silent epidemic. And anal cancer has also been reported to be on the rise. HPV cancer, therefore, continues to present a significant unmet medical need with large markets expected to continue to grow for the next couple of decades. We expect pricing to be competitive with current injectable immunotherapy at a little over $100,000 per year. Now it is important to note the versatility of the Versamune platform and its potential use with a wide range of tumor and infectious disease antigens. Our current pipeline involves the combination of Versamune with 4 different tumor antigens and 3 infectious disease antigens. It is also important to note that over 70 tumor antigens have been identified and reported. As part of our long-term strategy, we will continue to expand the development of the Versamune-based products through partnerships and licensing. We have some key upcoming milestones over the next few quarters. With PDS0101, we achieved an important milestone in the National Cancer Institute-initiated trial this quarter by meeting or exceeding our set objective response rate for tumor regression, which surpassed the highest response rate reported in this advanced recurrent HPV cancer population by at least 30%. Therefore, enabling full enrollment into the trial. We expect to present more mature data next quarter and potentially also during the third quarter. If recruitment efficiency continues to be maintained, we expect this trial to be completed in the first quarter of 2022. With the MD Anderson-initiated clinical trial in locally advanced cervical cancer, we expect as this trial is also already recruiting that preliminary data from this trial will be reported any time late in the fourth quarter or in the first quarter of 2022 bearing any unforeseen events. As we are running these trials in the middle of a pandemic, we anticipate that recruitment rates may be quite variable and quite difficult to accurately forecast. The same applies to our versatile 002 clinical trial, studying PDS0101 with Merck's KEYTRUDA in recurrent or metastatic head and neck cancer. This trial is also recruiting patients, and again, we expect interim data in about a year. So to summarize, our early clinical data as well as preclinical data suggest potentially superior efficacy of PDS0101 and the Versamune-based products. There is strong potential for near-term value appreciation based on the expectation of more mature data from the National Cancer Institute-led trial in advanced HPV cancer next quarter. We see our partnership with top immuno-oncology institutions for each of our 3 ongoing Phase II clinical trials as strong validation of our science, technology and target indications. Our ability and decision to combine PDS0101 with standard of care in 2 of the ongoing clinical studies we believe presents a potentially rapid path to commercialization of PDS0101, if the combination is demonstrated to be superior to the current standard of care. We also believe that this combination strategy with standard of care as well as our strategy of targeting multiple HPV-associated cancers after commercialization will facilitate rapid adoption of PDS0101 by oncologists. Thank you very much for the opportunity to present PDS Biotech today. Thank you.

Thank you, Frank. I want to thank all of our presenters for taking part of what has been a very productive informative series of presentations. We appreciate the time and effort that went into preparing them. Hopefully, our next conference will be one that we can hold in person rather than virtually. But in the meantime, we're very grateful for your flexibility and your presence online this year. Thank you again from the H.C. Wainwright team.