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spk01: 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.
spk04: 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.
spk00: 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?
spk03: Thank you, Frank, and thanks to everyone for joining us this morning. As Frank just highlighted, we've continued to progress both our oncology and infectious disease pipeline since our second quarter call. I'll begin with our ongoing oncology clinical trials and our lead candidate, PDS0101. Versatile 002 is a phase two study evaluating two groups of HPV16 positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor, also known as checkpoint inhibitor naive patients. The second group of patients have failed multiple treatments, including checkpoint inhibitor therapy, and are considered checkpoint inhibitor refractory. As Frank discussed during his remarks, this September we announced that the Versatile 002 study had achieved its preliminary safety benchmark in its first 15 patients. TDS-0101 treatment-related adverse events generally appeared to be limited to transient, manageable, local injection site reactions. Importantly, the combination also did not appear to exacerbate known Keytruda-related side effects. The achievement of this important milestone in the VERSATILE-002 trial strengthens the evidence regarding the safety of PDS-0101 in combination with other agents. Less than two weeks later, we achieved completion of enrollment of stage one for the checkpoint inhibitor-naive cohort in the VERSATILE-002 study. As specified in the clinical trial design, Enrollment is now paused for the checkpoint inhibitor naive cohort until the earliest achievement of at least four or more objective responses among the first 17 patients in this stage. According to standard RESIST 1.1 imaging criteria, the achievement of an objective response requires tumor reduction of 30% or more and must be confirmed on repeat imaging. In Versatile 002, imaging is performed every nine weeks during the first year. In the first stage of the trial, at least four of the first 17 patients in the checkpoint inhibitor naive arm and at least two of the first 21 patients in the checkpoint inhibitor refractory arm must achieve an objective response. Achievement of these milestones for each cohort will trigger advancement to the second stage of the study for both arms and full enrollment of the planned 95 patients. We anticipate the preliminary efficacy evaluation from the checkpoint inhibitor naive arm in Q1 of 2022. Recruitment to the checkpoint inhibitor refractory cohort is ongoing and with a planned efficacy evaluation of the first 21 patients expected in the second half of 2022. It's been noted that our objective response language in reference to the Versatile 002 study changed from objective response rate to best overall response in accordance with our revision to assignment two stage design. In this type of clinical trial design, Best objective response is the industry standard and does not change or eliminate the use of objective response criteria per RESIST 1.1 in the study. For reference, generally only about one in five checkpoint inhibitor-naive patients respond to initial treatment with checkpoint inhibitors. With the PDS-0101 Keytruda combination, we are seeking to improve objective responses to at least one in three patients. The situation is even more challenging for patients who have failed checkpoint inhibitors. Usually less than one in 10 checkpoint inhibitor refractory patients respond to treatment. We're seeking to double that with the PDS-0101 Keytruda combination so that one in five or more of these patients with very advanced refractory disease respond to treatment. We were pleased to have achieved the safety benchmark with no evidence of new or unanticipated toxicity related to the combination. Moving on to the NCI-led Phase II study evaluating PDS0101 in combination with two investigational immune-modulating agents in advanced HPV cancers. Highly encouraging interim data from this study was presented in early June at the ASCO annual meeting from 25 patients. Roughly half of the 56 patients planned to enroll in this trial. Recruitment into the trial was paused at the end of October due to an administrative issue, namely the need to update the National Cancer Institute's informed consent form for the study. This issue is not specific to the PDS-0101 combination trial and is unrelated to any safety or efficacy concerns with the specific triple combination being studied. Only the recruitment of new patients to the trial was impacted. Patients enrolled on the trial through the late October pause have continued to receive treatment on schedule. The updated informed consent form is now working its way through the NCI administrative approval process. Once it has been approved, recruitment in this trial will resume. The timing of clinical data resulting from this trial is not expected to be affected by the recruitment suspension. We still anticipate the completion of recruitment by the end of Q1 2022, and updated data from the study will be available in mid-2022. Moving on to the third trial, the MD Anderson-led ImmunoServe trial. This trial is a Phase II study evaluating PDS0101 in combination with standard of care chemoradiotherapy, or CRT, for the treatment of locally advanced cervical cancer. One of the interesting aspects of this trial will be the collection of immunogenicity and potential biomarker data, which may help further elucidate the immune response to PDS-0101 and how early markers may translate to clinical response. Preliminary results from ImmunoServe are still anticipated in mid-2022. Moving now to PDS-0102. Our recent licensing agreement with the NCI for the TARP tumor antigen is the next step in progressing the development of our versamine-based oncology pipeline product, PDS0102. Similar to PDS0101, PDS0102 will include versamine plus a mixture of TARP peptide antigens. In preclinical studies performed by PDS Biotech, the administration of PDS0102 led to effective induction of large numbers of killer T cells targeting TARP-expressing tumors, and preclinical development is near completion. The license agreement allows PDS Biotech to freely execute on clinical, regulatory, and commercial development plans to address cancers expressing TARP, including prostate cancer, breast cancer, and acute myeloid leukemia, or AML. We anticipate requesting a pre-IND meeting with the Food and Drug Administration by the end of the year. Now, moving on to PDS-0103, which combines diverse immune platform technology with novel, highly immunogenic agonist peptides of the tumor antigen MUC1. Agonist peptides are specifically designed and engineered to better stimulate an immune response. Importantly, MUC1 is highly expressed in multiple solid tumor types and has been shown to be associated with drug resistance and poorer disease prognosis. PDS is developing PDS0103 for the treatment of breast, colorectal, lung, ovarian, and other cancers. Similar to PDS0102, preclinical work for PDS0103 is near completion, with final studies being conducted at the NCI as we continue to progress our pipeline products into human clinical trials. We have already requested a pre-IND meeting with the FDA to align on a clinical development plan for the PDS-0103 program. A high-level synopsis of a proposed trial in different advanced solid tumors known to express MUC1 was included in the pre-IND meeting request. We anticipate a finalized study design and fully developed protocol in preparation for the meeting with the FDA. We have also made great progress with our infectious disease pipeline. As Frank noted, PDS-0202 combines averse immune with novel COBRA flu antigens developed by preeminent infectious disease expert Dr. Ted Ross at the University of Georgia. These antigens are designed to stimulate broadly reactive flu-specific antibody responses that can protect against both seasonal and pre-pandemic influenza strains. In combination, in combining these unique antigens with Burstein's T cell activating technology in PDS0202, we have an opportunity to develop a universal flu vaccine that potentially induces broadly reactive antibodies as well as T cells that target different flu strains. Preclinical results generated by PDS biotech and the University of Georgia completed over the summer were highly encouraging and documented a significant differentiating breadth of immune responses to influenza, as well as significant flu-specific neutralizing antibody and T cell responses. These flu responses parallel early results obtained with Burst Immune Plus SARS-CoV-2 antigens and a publication detailing both of these results is being prepared. In addition, PDS Biotech announced earlier this month an agreement with UGA to license these Cobra antigens for the use in a clinical trial, an important step in continuing to advance our infectious disease pipeline. We are now finalizing formulation work and are exploring funding opportunities to move the universal flu vaccine product into human clinical testing. I would like to expand on Frank's earlier point and summarize the potential breadth of indications being targeted in current and upcoming trials by PDS Biotech. Each versamune-based immunotherapeutic pipeline product is designed to attack a molecular target expressed in different types of cancer. PDS0101 targets HPV16 present in cervical, anal, head and neck, vulvar, vaginal, and penile cancer. PDS0102 targets TARP present in prostate and breast cancers as well as acute myeloid leukemia or AML. Finally, PDS0103 targets MUC1 that is present in non-small cell lung, breast, colorectal, ovarian, and multiple other cancers. As a consequence, PDS biotechs versus immune-based platforms have development potential for the treatment of at least 12 or more advanced solid tumors. many of which are responsible for a substantial burden of death due to cancer. Specifically, in 2019, lung, colorectal, pancreatic, breast, and prostate cancers accounted for 52% of cancer deaths. PDS Biotech will continue to embrace the challenge of these diseases as we seek to impact and improve the lives of as many cancer patients as possible. I would now like to turn the call over to our new Chief Financial Officer, Matt Hill, to review our third quarter 2021 financials. Matt?
spk07: Thank you, Lauren, and good morning, everyone. I'm very excited to have recently joined PDS Biotech. While technically it's only day 18 for me here as CFO, I've known Frank and some of the board members for over five years. I've been following the company and its success as a shareholder and a supporter of the technology. Frank has put together a top-notch team, has had great preliminary clinical data results, and with upcoming milestones, PDS Biotech is ready to take the next step in its evolution. For me, the successful company is one with the solid science, and Frank and Greg Kahn and the rest of the team have taken a measured, methodical approach to the science, and when I was able, I jumped at the opportunity to join the company. And with my background, I'm glad to have the chance to contribute to the team's success in leading the company's financial strategy in the next phase of growth. Now let's turn our discussion to review of our financial results. For the third quarter of 2021, we reported a net loss of approximately $7 million or 24 cents per basic and diluted share. as compared to a net loss of approximately $3.9 million, or 21 cents per basic and dual legit share, for the three months ended September 30, 2020. Research and development expenses increased to $3.7 million for the three months ended September 30, 2021, from $2.1 million for the three months ended September 30, 2020. The increase of $1.6 million was primarily attributable to an increase of $.7 million of personnel costs, of which $.5 million was stock compensation costs, and $.9 million in costs related to clinical studies. General and administrative expenses increased to $3.2 million for the three months ended September 30, 2021, from $1.8 million for the three months ended September 30, 2020. The increase of $1.4 million is primarily attributable to an increase in the personnel costs of $1.6 million, of which $1.0 million was related to stock compensation costs, and $.4 million was severance. This was partially offset by a decrease in professional fees of $.2 million. PDS biotech's cash and cash equivalents at September 30, 2021, were approximately $69.7 million. With our current plans, we have over two years of cash on hand. We will continue to manage our cash prudently to maximize the return in investments to advance both our oncology and infectious disease programs. The appreciation of our share price since the beginning of this year, along with a significant increase in the average daily trading volume, has greatly improved liquidity for our existing and future shareholders. Thank you for your time today. I'd like to now turn the call back to Frank for final remarks. Frank?
spk00: Thank you, Matt and Lauren. I would also like to thank our extremely diligent and innovative team here at PDS Biotech and all of our clinical partners for their continued dedication. The expertise and creativity demonstrated by our teams and collaborators continues to enable execution of our highly ambitious preclinical and clinical development strategies. I would also like to thank the patient who are the reason why we have dedicated our lives to this work. Our continued positive results and pipeline advancements this year have driven significant shareholder value. Year to date, PDS Biotech is among the highest performing stocks on NASDAQ. We still have significant upcoming milestones, which if achieved, we believe will continue this momentum. The groundwork has now been laid for the execution of multiple programs across the PDS Biotech pipeline into 2023. We have secured the financial runway and partnerships to work towards achievement of our value creating milestones. In the short term, we expect to receive top line data for multiple PDS 0101 trials between the fourth quarter of this year and first half of next year. We expect completion of recruitment of the National Cancer Institute-led trial addressing second and third line treatment of anal, cervical, head and neck, penile, vaginal, and vulva cancers in the first quarter. We also expect preliminary data from our versatile 002 trial by the first quarter of 2022. Preliminary data from our MD Anderson-led ImmunoServe trial is expected during the second quarter of 2022. Interim data from the PDS0101 molecularly targeted immunotherapeutic approach demonstrated clinical efficacy in all the advanced HPV-related cancers studied to date. We continue to progress towards additional milestones. We have multiplied shareholder value and demonstrated the potential of the company and technology to be in the forefront of immuno-oncology advancements, and we are impacting patients' lives. We look forward to sharing with you our future accomplishments as milestones are achieved. That concludes our prepared remarks. Operator, please begin our question and answer session.
spk01: Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question today, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants that are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. And our first question comes from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your questions. Ms. Chen, your line is open. Please proceed with your question. Perhaps you're on mute.
spk06: Hi. Can you hear me?
spk07: Yes, we can. Hello? Yes.
spk06: Okay. Thank you. Sorry about that. So congratulations on all the progress this quarter. I had a few questions for you. Could you give any more color on the economics for your NCI TARP collaboration? And what is the market opportunity here that you see? Second question I had for you is, can you elaborate more on your universal flu vaccine? I know you talked about it on your call, but how does your technology broadly compare to others in development? Because there are a few projects here on the universal flu vaccine front. And then can you provide any more color on PDS 0103? and your rationale behind this Mach 1 target. Thank you very much.
spk00: Luis, thanks a lot for those questions. So let's start with the NCI. So with the NCI and the licensing of the TARP antigen, a lot of that has been specifically redacted by the National Cancer Institute specifically, but this would be a typical licensing agreement with very reasonable economics. And with regards to the market opportunity for the TARP program, I think as Lauren mentioned, this is present in three very large market cancers, actually two very large market cancers, breast and prostate, as well as AML. So with AML, for example, there are approximately 20,000 cases annually in the United States. And TARP is reportedly expressed in 100% of these patients' tumors. With prostate cancer in the United States alone, we have almost 175,000 cases annually. And the TARP protein is expressed in about 90% of these prostate cancers at all stages of the disease. And with breast cancer, again, we have more than 270,000 cases annually in the United States alone. And TARP is expressed in about 50% of these cancers. So when you look at these cancers, the market opportunity is significant. the unmet need is extremely significant, and so we see significant potential for the PDS-0102 program, just based upon the need and the size of the markets. And with PDS-0103, again, we're looking at the MUC1-related cancers, and the rationale for this approach is MUC1, as you know, has been studied in cancer vaccines over the last decade or so, the initial approaches to evaluating MOC1 have not been successful. Now, with the PDS0103 program, there are two very significant differences between what has been done in the past and what's being done today with PDS0103. First of all, the specific antigens. So what we are using are not the native Mach 1 antigens, which were shown to be very weakly immunogenic. The PDS-0103 is based on novel agonist epitopes of the Mach 1, which have been designed and patented by the lab of Dr. Jeff Shlom at the National Cancer Institute. These novel agonist epitopes of Mach 1 have been shown to be dramatically more immunogenic than the native Mach 1. So that's what our PDS-0103 is based on. Now, secondly, what's different is diverse immune technology itself. For the first time, what we've seen is the technology that actually activates the critical immunological pathways that are necessary to induce a powerful antigen-specific immune response. The effective presentation to the immune system presentation into the MHC class 1 and class 2 pathways, as well as upregulation of the type 1 interference. And so with these combined, both the Versamune and these novel highly immunogenic epitopes, what we've demonstrated is that in preclinical models, we can generate very powerful CD8 T cell responses similar to what we see with PDS0101. And we've also characterized these T cells to show that they are highly polyfunctional, which means that they are the phenotype of T cell that is much more highly potent and active in its killing capability. And so this is really different, and that's why we believe PDS-0103 is also extremely important and why we're so excited about the potential of PDS-0103. And as you know, the markets, as Lauren mentioned, these are very significant markets with huge unmet needs, colorectal cancer, non-small cell lung cancer, breast cancer, ovarian cancer, and a number of other solid tumors. So, Louise, I hope this answered your questions.
spk06: It does. Thank you very much.
spk00: Thanks a lot.
spk01: As a reminder, to ask a question today, you may press star 1 from your telephone keypad. The next question comes from the line of Leland Gershaw with Oppenheimer. Please just hear with your questions.
spk08: Great. Good morning. Thank you, and glad to hear on the continued progress. Frank, a couple questions for me. First, on the NCI trial with the pause, it sounds like timelines are still intact, but just wanted to know if there's any further color you can provide on what may change as that trial resumes. Would it be a change in simply consent forms? Would there be anything that might be more um more involved and then also want to ask matt um obviously you've got a couple years of cash but just want to ask with respect to our modeling on r d expense how we might want to um uh think about that for 2022 just given um you know the various programs that you're uh you're deploying capital into versus this past year thank you okay
spk00: So Linda, I'll answer the first question and then I'll hand over to Matt to address the cash runway over the next year or two. So with the NCI program, I think what Lauren expressed is the extent of our knowledge today. They have assured us, as we've said, that this is purely administrative. It's an updating of the patient informed consent. We've been informed as of last week that that had been completed and it's working its way through the administrative process at the National Cancer Institute. The patients currently on the trial are still receiving treatment on schedule. Nothing has changed. And once that update to the informed consent is approved and they're given the green light, again, nothing will change. It is just that informed consent document that will be provided to the patients that would have that requested update included in it. And so as of today, we do not expect any delays to the timeline that we proposed initially. We're still on schedule to complete recruitment during the first quarter of next year. So as of today, everything is still on schedule. And based on our discussions with the National Cancer Institute, they do not appear to have any concerns that they'll encounter, any delays, they've assured us that this is an administrative process that is working its way through the various departments at the NCI, and hopefully they will get started in the near term. So I will hand over to Matt.
spk07: Good morning, Leland. Thanks for your question. It's a good question. When we're looking at, and I'll walk you through it so that you can back into R&D. So essentially we've got two years of cash on hand. That means there's at least nine quarters of cash on hand. You can assume that that's going to be the burn of cash will be weighted more in 2022. We had about $3.3 million worth of administrative expenses in Q3. You can expect that to increase slightly and level off. and then the difference in the cash burn will be R&D costs.
spk08: Terrific. Okay, that's very helpful. Thanks very much for taking the question.
spk07: You're welcome. No problem. Have a great day.
spk01: Thank you. Our next question is from the line of Emanuela Brancetti with AT Wainwright. Please proceed with your questions.
spk05: Good morning, everyone, and thank you for taking my questions. With regards to PDS-0102, I was hoping you could tell us more about your thoughts on the path forward. Are you thinking about prioritizing one indication, perhaps prostate cancer, over the others, or could you potentially begin in the clinic with a basket study? And related to this question, obviously you have the NCI data in prostate cancer, but could you remind me if preclinically one indication stands out as the most promising at the moment?
spk00: Yes, Manuel, thank you very much for that question. That's a really good question and a lot of consideration has been given to the specific question within PDS. And I think based upon our approach to risk mitigation and potential for success, based upon the fact that the National Cancer Institute has performed a clinical trial in prostate cancer specifically, and shown this antigen, TARP antigen, to be immunogenic in these patients and actually provide anti-cancer benefits to the patients, very likely with this specific program will very likely start with prostate cancer. That has not been finalized yet, but that is the direction in which we are heading, or at least more likely to go by just based upon the current data available to us and what the NCI has already demonstrated in these patients.
spk05: Got it, got it. Thank you for that. And so if this is the case, would you be able to start with a phase two since I believe you already have phase one data from the NCI?
spk00: Yes, we believe that in this case, very likely, based upon the fact that we already have data in humans with Versimune, and the protein, the TARP antigen has already been in humans, that we may have to do a very, we can do a combined phase one, two, where we just demonstrated the first few patients that it's safe and transitioned seamlessly into the phase two trial. But I will hand over to Lauren to confirm this for us. Lauren?
spk03: Yes, Frank. Yes. Thank you, Frank. That's exactly our expectation. that because of the prior human experience with TAR peptides, specifically in the prostate cancer setting, that we would be able to do a combined Phase I-II study with very limited immunogenicity and safety confirmation before proceeding into Phase II aspect of studying the agent. The other reason for going into prostate cancer is As Frank previously highlighted, we know TARP is expressed in approximately 90% of prostate cancers. Since it's only expressed in 50% of breast cancers, we anticipate that the agency, the FDA, might require co-development of a companion diagnostic for a breast cancer indication. Again, another reason for us to target going into prostate cancer initially.
spk05: Yep, yep, that makes sense. Thank you very much.
spk01: Thank you. Our next question is from the line of Laura Furin with Alliance Global Partners. Please proceed with your questions.
spk02: Hello, this is Laura Furin in representation of Jim Malloy. So congratulations on the progress made this quarter. And regarding the HPV triple combo trial, may you please talk about a little bit more of the data that you need to see in this trial in order to apply for a non-location-specific tumor type? And regarding this trial as well, may you please talk about the number of patients that you need to see or are anticipating in this trial by the next interim look in ASCO for the upcoming year of 2022. And my last question is just regarding your partnerships. So besides Merck, do you have any plans to bring on any other partnerships to partner your Versamium platform? Thank you.
spk00: Thanks a lot. So quite a few topics here. So with the initial data or the preliminary data was generated in two patient types. The first one where the HPV, sorry, the checkpoint inhibitor naive patient population. And with these patients, typically what you'll see is approximately a 15% to 20% response rates with the standard of care, which are the checkpoint inhibitors. So that is what we were comparing to. And the statistical analysis will be done based upon those specific patients. So we needed to achieve three out of the first eight positive responses as the benchmark for continuing the study. And as you know, we achieved five out of the first six. The efficacy rate in the checkpoint inhibitor-naive arm is much, much higher than has been generated before in any trial with this specific patient population. The next second arm of the trial is evaluating patients who have, in addition to chemo and radiation, also failed checkpoint inhibitor therapy. Now, as you may know, with this patient population, These patients have extremely few options available to them. And the response rate efficacy rates in this patient population is somewhere between the range of five to 10% maximum, right? So very few drugs have any effect on a very small percentage of these patients. And we're seeing response rates around the 50% range with these patients. And so what we want to do now is even though these patients are still being recruited and still being evaluated, we will be having discussions with both the National Cancer Institute and EMD Sirona, who own the two other agents that are being evaluated in this triple combination. And we would like to have a discussion with the FDA to find out from the FDA what they would want to see in a pivotal trial design. But the data is so compelling, that we believe the earlier we can have these discussions with the FDA, the better, and understanding from the FDA what they would want to see. Because we know the FDA is looking for new approaches to treating cancer. They're looking for novel combinations that can significantly move the needle. And that's exactly what we've demonstrated with this novel triple combination. These are three different agents, each of which acts by a different anti-tumor mechanism And we can see that if these numbers hold up or anywhere close to what we've generated today, this will be a significant advancement in the treatment of these patients, right? And so these are discussions that we are anticipating beginning to have with the FDA very soon and discussing what the pathway would be and how rapidly we can take this into commercial development. And in terms of the partnerships, So currently, as you know, with this triple combination, even though the trial is led by the National Cancer Institute, the three agents are owned by PDS Biotech and EMD Serono. So we are also in communication with the EMD Serono team. And with the second trial, the Versal 002 trial, this is a collaboration with Merck, the U.S. Merck. With the other trials, we're still collaborating with the National Cancer Institute with the PDS-0103 and PDS-0102. We anticipate the second portion of our business strategy would then be the partnership and potential licensing opportunities for the platform. But we believe that what's really important to successfully execute on the second arm of the strategy is to clearly demonstrate proof of concept. and to really demonstrate that we have been able to accomplish what a number of technologies have not been able to do in the past, which is the in vivo generation of these powerful tumor attacking T cells. And so the additional data that's coming out of the NCI triple combination trial, as well as the data that we should be hopefully seeing from the versatile 002 trial, will be very important in really establishing the solid proof of concept and demonstration of the various immune technologies potential in treating these cancer patients. And we believe that will be important for the second piece that you were asking about, which is partnering with a broader range of pharmaceutical companies and also out-licensing this technology to other companies. So as you know, in cancer specifically, over 50 antigens have been identified. PDS will never have the resources to be able to develop every single one of those tumor antigens. And so we anticipate that we will work step selectively and strategically with other potential cancer immunotherapy companies who may want to utilize our technology in indications which PDS might not have initially targeted in which we can work with those companies to address some of those indications. Did that answer your questions?
spk02: Yes. Thank you so much.
spk00: Thanks a lot.
spk01: Thank you. At this time, we've reached the end of the question and answer session. I'll now turn the call over to Frank Badu-Addo for closing remarks.
spk00: Thank you very much. So thank you very much to all of you for your continued interest in PDS Biotech. We believe that 2021 will continue to be an exciting year for the company. We have multiple ongoing clinical trials of PDS-0101 in various advanced HPV-associated cancers, and we are preparing to advance additional products into the clinic. We appreciate your ongoing support in this pursuit. For more information about the company and our ongoing clinical trial, please visit our website at pdsbiotech.com. Thank you very much again.
spk01: Thank you. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.
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