Earnings Call Transcript - PDSB Q3 2021

Operator, Operator

Greetings and welcome to PDS Biotechnology’s Third Quarter 2021 Earnings Call and Webcast. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. Please note, this conference is being recorded. At this time, I would now turn the conference over to, Deanne Randolph, Vice President of Commercial Development. Deanne, you may now begin.

Deanne Randolph, Vice President of Commercial Development

Good morning, and welcome to PDS Biotechnology’s third quarter 2021 earnings conference call and audio webcast. With me today are Dr. Frank Bedu-Addo, 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 Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve material risks and uncertainties, 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 Bedu-Addo.

Frank Bedu-Addo, CEO

Thank you, Deanne, and thanks to everyone on the call today. Last year at PDS Biotech, we initiated the execution of our oncology clinical strategy and outlined key milestones that we have plans to achieve in 2021 and 2022. PDS Biotech is still on track to achieve each of these milestones on schedule with ongoing progression of pipeline programs. 2021 has been an extraordinary year for PDS Biotech. We shared extremely promising interim results of PDS0101 from ongoing clinical trials, and this quarter have continued to progress our pipeline programs toward the commercialization of what we believe are transformative treatments for cancer. As we begin to see the positive human impact Versamune-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 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 PDS0101-based combination in patients with anal cancer, cervical cancer, head and neck cancer, penile cancer, vaginal cancer, and vulvar 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 Versamune platform’s potential ability to recruit, train, and activate large numbers of critical cancer-attacking killer T-cells, even in very old patients, and may overcome a key limitation of cancer immunotherapy. The strong proof of concept data suggests potential utility of Versamune in the development of molecularly targeted cancer therapies 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 to clinical development. We are focused on executing our PDS0101 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. In September, we announced the 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 I enrollment of the Simon Two Stage Design for this cohort of the study. Additionally, 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. PDS0102 combines the Versamune platform technology with the proprietary T-cell receptor Gamma Alternate Reading Frame Protein, 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 pre-clinical results, we are excited about the potential of PDS0102 as the second molecularly targeted immune therapy 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 PDS0103, which targets the MUC1 protein present in multiple solid tumors. We have requested a pre-IND meeting with the FDA for PDS0103. The Versamune technology is preparing our molecularly targeted immunotherapies for a broad range of cancers. It is the potential of Versamune 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 experts, Dr. Ted Ross at the University of Georgia. Dr. Ross leads one of the NIAID’s Collaborative Influenza Vaccine Innovation Centers, CIVICS based at UGA. 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 Versamune-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 huge advancements 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 Farmacore program and have aligned on key manufacturing and regulatory milestones that must be met in the short-term. Farmacore 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 Farmacore, which is scheduled to end on November 30th, by six months through May 2022. We will be closely monitoring their progress through this period. After results 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 would like to talk 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 Wood, Chief Medical Officer

Thank you, Frank. And thanks to everyone for joining us this morning. As Frank just highlighted, we have continued to progress both our oncology and infectious disease pipeline since our second quarter call. I will begin with our ongoing oncology clinical trials and our lead candidate PDS0101. VERSATILE-002 is a Phase II 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 has 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 benchmarks in its first 15 patients. PDS0101 treatment-related adverse events generally appeared to be limited to transient, manageable local injection-type 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 PDS0101 in combination with other agents. Less than two weeks later, we achieved completion of enrollment of Stage 1 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. 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 advancements 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, with a planned efficacy evaluation of the first 21 patients expected in the second half of 2022. It has 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 a Simon 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 PDS0101-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 are seeking to double that with the PDS0101-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 administrative issues, namely the need to update the National Cancer Institute’s Informed Consent Form for the study. This issue is not specific to the PDS0101 combination trial, and it 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 in 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 this study will be available in mid-2022. Moving on to the third trial, the MD Anderson-led Immuno Serve trial. This trial is a Phase II study evaluating PDS0101 in combination with standard-of-care, chemotherapy, 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 to further elucidate the immune response to PDS0101 and how early markers may translate to clinical response. Preliminary results from Immuno Serve are still anticipated in mid-2022. Moving now to PDS0102. Our recent licensing agreement with the NCI for the TARP tumor antigen is the next step in progressing the development of our Versamune-based oncology pipeline products PDS0102. Similar to PDS0101, PDS0102 will include Versamune 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 PDS0103, which combines the Versamune 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 associated with drug resistance and poor 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 PDS0103 program. A high-level synopsis of a proposed trial and different advances of all the tumors known to express MUC1 was included in the pre-IND meeting requests. 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 pipelines. As Frank noted, PDS0202 combined diverse immune and 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 combining these unique antigens with Versamune’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 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 Versamune 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 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 molecular targets 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 Biotech's Versamune-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.

Matthew Hill, Chief Financial Officer

Thank you, Lauren and good morning, everyone. I’m very excited to have recently joined PDS Biotech. Well, technically, it is only day 18 for me here as CFO. I have known Frank and some of the Board members for five years. I have 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 poised to take the next step in its evolution. For me, a successful company is one with solid science, and Frank and the rest of the team have taken a measured, methodical approach to the science. When I was able, I jumped at the opportunity to join the Company. With my background, I’m glad to have a chance to contribute to the team’s success by leading the Company’s financial strategy in the next phase of growth. Now let’s turn our discussion to a review of our financial results. For the third quarter of 2021, we reported a net loss of approximately $7 million or $0.24 for basic and diluted share as compared to a net loss of approximately $3.9 million or $0.21 per basic and diluted 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 $0.7 million in personnel costs, of which $0.5 million was stock compensation costs, and $0.9 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 personnel costs of $1.6 million, of which $1.0 million was related to stock compensation costs and $0.4 million was severance. This was partially offset by a decrease in professional fees of $0.2 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 investments to invest in 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 existing and future shareholders. Thank you for your time today. I would like to now turn the call back to Frank for final remarks.

Frank Bedu-Addo, CEO

Thank you, Matt and Lauren. I would also like to sign 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 continue to enable execution of our highly ambitious preclinical and clinical development strategies. I would also like to thank the patients 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; if achieved, we believe we 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 the achievement of our value-creating milestones. In the short-term, we expect to receive top-line data for multiple PDS0101 trials between the fourth quarter of this year and the first half of next year. We expect the 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 vulvar 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 Immuno Serve trial is expected during the second quarter of 2022. Interim data from the PDS0101 molecularly targeted immunotherapeutic approach has demonstrated clinical efficacy in all the advanced HPV-related cancers studied to date. We continue to progress toward additional milestones. We have multiplied shareholder value and demonstrated the potential of the Company and technology in the forefront of immuno-oncology advancements, and we are impacting patients' lives. We look forward to sharing our future accomplishments as milestones are achieved. That concludes our prepared remarks. Operator, please begin our question-and-answer session.

Operator, Operator

Thank you. And our first question comes from the line of Louise Chen with Cantor Fitzgerald. Please proceed with your question.

Louise Chen, Analyst

Okay. Thank you. Sorry about that. So congratulations on all the progress this quarter. I had a few questions for you. So, 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? There are a few projects here on the universal flu vaccine front. And then, can you provide any more color on PDS0103 and your rationale behind this MUC1 target? Thank you very much.

Frank Bedu-Addo, CEO

Louise, thanks 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 to be specifically redacted by the National Cancer Institute, but this would be a typical licensing agreement with reasonable economics. And with regard 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 PDS0102 program just based upon the need and the size of the markets. And with PDS0103 again, we are looking at the MUC1-related cancers, and the rationale for this approach is MUC1, as you know, has been steady in cancer vaccines over the last decade or so. The initial approaches to evaluating MUC1 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 is being done today with PDS0103. First of all, the specific antigens, so what we are using are not the native MUC1 antigens, which were shown to be very weakly immunogenic. The PDS0103 is based on novel agonist epitopes of the MUC1, which have been designed and patented by the lab of Dr. Jeff Schlom at the National Cancer Institute. These novel epitopes of MUC1 have been shown to be dramatically more immunogenic than the native MUC1, so that is what our PDS0103 is based on. Now, secondly, what is different is the Versamune technology itself. For the first time, what we have seen is the technology that actually activates the critical immunological pathways that are necessary to induce a powerful antigen-specific immune response by the effective presentation to the immune system presentation into the MUC Class 1 and Class 2 pathways, as well as proper regulation of Type-1 interferon. And so with this combination, both Versamune and these novel highly immunogenic epitopes, what we have demonstrated is that in preclinical models, we can generate very powerful CD8 T-cell responses, similar to what we see with PDS0101. We have also characterized these T-cells to show that they are highly polyfunctional, which means that 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 is why we believe PDS0103 is also extremely important and why we are so excited about the potential of PDS0103. And as you know, the markets Dr. 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, I hope this answered your questions.

Louise Chen, Analyst

It does. Thank you very much.

Frank Bedu-Addo, CEO

Thanks a lot.

Operator, Operator

The next question comes from the line of Leland Gershell with Oppenheimer. Please proceed with your question.

Leland Gershell, Analyst

Great, good morning. Thank you. And glad to hear about your continued progress. Frank, couple of questions for me. First, on the NCI trial with the pause, it sounds like timelines are still intact, but just wanting to know if there is any further color you can provide on what may change as that trial resumes. Would it be a change in simply content forms or would there be anything that might be more involved? And then also want to ask Matt. Obviously, you've got a couple of years of gap, but just wanted to ask with respect to our modeling on R&D expense, how we might want to think about that for 2022, just given the various programs that you are deploying capital into versus this past year.

Frank Bedu-Addo, CEO

Okay. So Leland, I will answer the first question, and then I will hand over to Matt to address the cash runway over the next year or so. So, with the NCI program, I think what Lauren expressed is the extent of our knowledge today. They have assured us that this is purely administrative. It is an updating of the patient informed consent. We have been informed as of last week that that had been completed and is working its way through the administrative process of the National Cancer Institute. The patients currently on the trial are also receiving treatment on schedule, and nothing has changed. And once that update to the informed consent is approved, again, nothing will change. It is just that informed consent document that will be provided to the patients that would have those requested updates included in it. So, as of today, we do not expect any delays to the timeline that we proposed initially; we are 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 will encounter any delays. They have assured us that this is an administrative process that is working its way through the various departments of the NCI. And hopefully, they will get started in the near term. So, I will hand over to Matt.

Matthew Hill, Chief Financial Officer

Good morning, Leland. Thanks for your questions. Good questions. We are looking at, and I will walk you through it so that you can back into R&D. Essentially, we have got two years of cash on hand, meaning at least nine quarters worth of cash on hand. You can assume that 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.

Leland Gershell, Analyst

Terrific, okay that is very helpful. Thanks very much for taking the questions.

Frank Bedu-Addo, CEO

You are welcome, no problem.

Matthew Hill, Chief Financial Officer

Have a great day.

Operator, Operator

Thank you. Our next question is from the line of Emanuela Branchetti with H. C. Wainwright. Please proceed with your questions.

Emanuela Branchetti, Analyst

Good morning, everyone. And thank you for taking my questions. With regards to PDS0102, I was hoping you could tell us more about your thoughts on the path forward. Are you thinking about prioritizing indication that has prostate cancer over the others? Where could you potentially begin with the baskets? And related to this question, obviously, you have the NCI data in prostate cancer, but could you remind me if clinically one indication stands out as the most promising at the moment?

Frank Bedu-Addo, CEO

Yes, Emanuela, thank you very much for that question. That is a really good question. Lots of consideration has been given to this specific question within PDS. I think based upon our approach to risk mitigation and potential for success, based upon the fact that the National Cancer Institute has performed the 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, it is very likely that 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. It is more likely to go in that direction based upon the current data available to us and what the NCI has already demonstrated in these patients.

Emanuela Branchetti, Analyst

Got it. Thank you for that. And so, if this is the case, would you be able to start with a Phase II since you, I believe, already have Phase I data from the NCI?

Frank Bedu-Addo, CEO

Yes. We believe that, in this case, very likely based on the fact that we already have data in humans with Versamune and the TARP protein that has already been in humans. We may have to do a very - we can do a combined Phase I/II, where we demonstrate the first few patients that could be safe and transition seamlessly into the Phase II trial. But I will hand it over to Lauren to confirm this for us. Lauren.

Lauren Wood, Chief Medical Officer

Yes. Thank you, Frank. That is exactly our expectations that because of the prior human experience with TARP peptides, specifically in the prostate cancer setting, we would be able to do a combined Phase I/II study with very limited immunogenicity and safety confirmation before proceeding into the 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 is only expressed in 50% of breast cancers, we anticipate that the FDA might require co-development of a companion diagnostic for the breast cancer indication. Again, another reason for us to target going into prostate cancer initially.

Emanuela Branchetti, Analyst

Yes. That makes sense. Thank you very much.

Operator, Operator

Thank you. Our next question from line of (Ph) with Alliance Global Partners. Please proceed with your question.

Unidentified Analyst, Analyst

Hello. This is (Ph) in representation of Jim Molloy. So congratulations on the progress made this quarter regarding the HPV triple combo. Maybe 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, maybe please talk about the number of patients that you need to see or are anticipating in this trial by the next interim ASCO for the upcoming year 2022? And my last question is just regarding all your partnerships. So, besides Merck, do you have any plans to bring on any other partnerships to partner your Versamune platform? Thank you.

Frank Bedu-Addo, CEO

Thanks a lot. So, quite a few topics here. With the initial data, the preliminary data was generated in two patient types. The first population was that of HPV - sorry, this checkpoint inhibitor naive patient population. With these patients, typically what you see is approximately a 15% to 20% response rates with standard-of-care without the checkpoint inhibitor. That is what you were comparing to. The statistical analysis will be based upon those specific patients. We needed to achieve three out of the first eight positive responses as the benchmark for continuing the study. As you know, we have achieved five out of the first six. So, the efficacy rate in the checkpoint inhibitor naive arm is much, much higher than has been generated before in any trial with a specific patient population. The second arm of the trial involves patients who are in addition to chemo and radiation also failed checkpoint inhibitor therapy. As you may know, with this patient population, these patients have extremely few options available to them. The response efficacy rates in this patient population is somewhere between the range of 5% to 10% maximum, so very few drugs have any effects on a very small percentage of these patients. We are seeing response rates around the 50% range with these patients. 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 Serono, who own the two other agents that have been evaluated in this triple combination. We would like to begin discussions with the FDA to find out what they would want to see in a pivotal trial design. The data is so compelling that we believe that the earlier we can have these discussions with the FDA, the better. The FDA is looking for new approaches to treating cancer. They are looking for novel combinations that can significantly move the needle. And that is exactly what we have demonstrated with this novel triple combination. These are three different agents, each of which acts by a different anti-tumor mechanism. We can see that if these numbers hold up with close to what we have generated today, this will be a significant advancement in the treatment of these patients. In terms of the partnerships, as you know, with this triple combination, even though the trial led by the National Cancer Institute, the three agents are owned by PDS Biotech and EMD Serono. We are all staying in communication with the EMD Serono team. And with the other trials, we are still collaborating with the National Cancer Institute with PDS0103 and PDS0102. We anticipate that the second portion of our business strategy would be the partnership and potential licensing opportunities for the platform. However, we believe that what is truly important to successfully execute the second arm of the strategy is to clearly demonstrate proof of concept, and to really show that we have accomplished 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. The additional data that is coming out of the NCI triple combination trial, as well as the data that we should be hoping to see from the VERSATILE-002 trial will be very important in establishing a solid proof of concept for the Versamune technology's potential in treating these cancer patients. We believe that will be imperative for the second piece that you were asking about, which is partnering with a broader range of pharmaceutical companies, as well as out-licensing this technology to other companies. In cancer specifically, over 15 antigens have been identified, and PDS will never have the resources to be able to develop every single one of those tumor antigens. We anticipate that we will work collectively and strategically with other potential cancer immunotherapy companies who may want to utilize our technology in indications that PDS might not have initially targeted.

Unidentified Analyst, Analyst

Yes. Thank you so much.

Frank Bedu-Addo, CEO

Thanks a lot.

Operator, Operator

Thank you. At this time, we have reached the end of the question-and-answer session, and I will now turn the call over to Frank Bedu-Addo for closing remarks.

Frank Bedu-Addo, CEO

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 with PDS0101 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.

Operator, Operator

Thank you. This will conclude today’s conference. You may disconnect your lines at this time, and thank you for your participation.