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spk08: in combination with Merck's Keytruda in recurrent or metastatic HPV-positive head and neck cancer. Safety data was presented at the multidisciplinary head and neck cancers symposium in February, and successful achievement of the preliminary efficacy milestone was also reported this February. Based on the successful attainment of the preliminary efficacy milestone in checkpoint inhibitor naive subjects, We similarly anticipate presenting more detailed efficacy results at an upcoming peer-reviewed conference in the coming months. For the MD Anderson-led trial evaluating PDS-0101 in combination with chemoradiotherapy in locally advanced cervical cancer, we still remain on track to provide data late in Q2 or early Q3. This quarter, we announced the initiation of a new PDS-0101 trial to be led by Mayo Clinic. This trial is studying the use of PDS-0101 with and without Keytruda as a potential neoadjuvant treatment for oral cancer and open to recruitment this month. We hope to see preliminary data in Q4 of this year or Q1 next year. Dr. Wood will take us through the more detailed clinical updates. The Mayo Clinic was selected to replace the previously projected PDS0102 trial. This decision was strategic to capitalize on the commercial opportunity to expand the target market for PDS0101 to early stage disease. With the reported rapid increases in the incidence of HPV-associated oral cancer, there is a growing number of early stage cancer patients who may benefit from treatment with an immunotherapy such as PDS-0101. It is noteworthy that all of our clinical programs are partnered with distinguished leaders in oncology and immuno-oncology, which we believe provides strong validation of our science and approach. In addition, these relationships through cost-sharing agreements have also significantly mitigated the financial burden of advancing our expanding clinical pipeline. PDS0102 and PDS0103 have completed preclinical development. Our three immunotherapies currently in development, PDS0101, PDS0102, and PDS0103, present a multi-billion dollar opportunity. PDS0101 addresses an approximately $5 to $6 billion US market. PDS0102 addresses cancers containing a protein we call TARP, T-A-R-P, including prostate cancer, breast cancer, and acute myeloid leukemia. It is estimated that there are over 300,000 new cases of these TARP-associated cancers in the United States every year. We believe the majority of these patients may benefit from PDS0102 immunotherapy. This is an approximately $45 billion addressable market. PDS0103 addresses cancers containing a protein called MUC1, M-U-C-1. These include colon, breast, ovarian, and lung cancers, another very significant market opportunity. We anticipate initiating clinical evaluation of PDS-0103 during the second half of this year. I will briefly discuss our infectious disease pipeline. These products are based on our Infectimmune platform, which is designed to induce broadly acting neutralizing antibodies in addition to T cells. The most progressed of these programs are PDS0202, which is a universal flu vaccine, and PDS0203, a second generation COVID-19 vaccine. PDS0201, our tuberculosis vaccine, was deprioritized in 2020 in order to develop the COVID-19 vaccine. PDS0202 combines infectimmune with novel computationally designed proteins that were developed by Dr. Ted Ross, a world-renowned flu expert. This program is funded by the National Institutes of Allergy and Infectious Diseases, NIAID. With PDS0202, our goal is to develop a vaccine that, unlike the current flu vaccines, may provide robust protection against multiple strains of the flu. Impressive data demonstrating the potential of our infectimmune technology to induce high levels of broadly protective neutralizing antibodies was presented. This led to effective protection against infection and sickness. Dr. Wood will provide additional details on the study and results. PDS0203, our second generation COVID-19 vaccine, is being developed under license from PDS Biotech by the Brazilian company Pharmacor for Latin America. We expect that a strong neutralizing antibody and CD8 T-cell activating vaccine may produce more durable or longer protection against multiple strains of the virus. Pharmacor is fully responsible for product development and is currently performing manufacturing development and scale-up. Clinical development is to be funded by the government of Brazil. We will provide updates as they become available. As part of our goal of successfully commercializing our pipeline product, We also completed a number of licensing transactions and continued to build partnerships, not only securing intellectual property for our expanding pipeline, but also enhancing our relationships with global organizations. We announced the licensing of the top proteins expressed in prostate cancer, breast cancer, and acute myeloid leukemia from the National Cancer Institute in Q4 of 2021. In addition, we announced an agreement to license the computationally optimized broadly reactive antigens, also called COBRA, used in our universal influenza vaccine, PDS0202, from the University of Georgia. And lastly, as you can see here, we strengthened our corporate leadership, adding distinguished immuno-oncology experts to our scientific advisory board and welcoming Matt Hill as our chief financial officer. We also reported that the company was added to the Russell Microcap Index in late 2021. And importantly, we added more than $52 million to our balance sheet, significantly extending our cash runway and ability to continue to advance our drug development programs. As most of you already know, our oncology and infectious disease pipelines are based on two proprietary platforms. Versamune and Infectimmune, respectively. With our Versamune platform, we are developing a new class of molecularly targeted immunotherapies, which have demonstrated excellent potential to induce in vivo or within our bodies tumor-attacking killer T-cells, also known as CD8 T-cells. Our ability to achieve this, we believe, presents strong potential to overcome one of the biggest limitations of immune oncology. The ability to induce T cells in vivo is neither novel nor unique. What is however unique about Versimune is its ability to, first of all, induce the right type of killer T cells, secondly, to promote powerful killing potency of the killer T cells, and thirdly, to generate large numbers of these induced potent killer T, the right quantity and the right potency. Versamune also induces memory T cell responses, which are important in generating prolonged clinical efficacy. Versamune's method of T cell activation has presented early indications of potential for a combination of potency and safety. With that introduction, I will now hand over to Dr. Lauren Wood, PDS Biotech's Chief Medical Officer, to provide additional details on our ongoing clinical studies. Lauren?
spk02: Thanks, Frank, and thanks to all for joining us today. Our most progressed clinical program is the National Cancer Institute-sponsored Phase II trial studying PDS-0101 in combination with both Bintra-FUSP-alpha, or Bintra for short, and M9241, also known as NHS IL-12, two investigational immune-modulating candidates owned by Merck KGAA. The study is investigating the combination in patients with recurrent or metastatic HPV-positive cancers, including anal, cervical, head and neck, penile, vaginal, and vulvar cancers who have failed prior treatment. One cohort is evaluating patients who have not been treated with checkpoint inhibitors and have not responded to at least one standard of care therapy. These are CPI-naive patients. Almost all patients in this cohort have failed both chemotherapy and radiation treatments and would be moving on to checkpoint inhibitor therapy as a potential treatment option. The second cohort is evaluating the triple combination as a third-line treatment in patients with recurrent or metastatic HPV-positive cancers who have failed checkpoint inhibitor therapy. These are the CPI refractory patients. To date, the study has recruited 45 patients. As of December 31st, 2021, 30 patients who are HPV-16 positive had at least one evaluation. There's currently about a three-to-one ratio of CPI refractory patients to CPI-naive patients enrolled in the trial. This means that we have a significantly larger number of patients who have failed all of the treatment options being studied. As reported at ASCO in 2021 by the NCI, CPI naive patients historically have a median survival of seven to 11 months on CPI monotherapy. CPI refractory patients who have failed all three treatment approaches have a historical median survival of only three to four months. As of December 31st, 2021, the median overall survival of these patients on this study exceeds 12 months and counting. These results are extremely promising, especially given the limited treatment options for the majority of this population and presents a severe unmet medical need. On treatment with the triple combination, almost 70% of patients, including those who are CPI-naive and CPI-refractory, experience tumor shrinkage. These preliminary results may suggest that these refractory cancer patients may not only be living longer, but the majority also appear to be experiencing tumor shrinkage. In this study, an important observation was made with the patients whose tumors were not positive for HPV16, the HPV16 negative patients. Although these patients appear to have a potential survival benefit, no tumor shrinkage was observed in this population because they do not express the HPV16 protein target for PDSO101. The contrasting tumor shrinkage seen in HPV16 positive patients is an important result. because it strongly suggests that PDS0101 is effectively training killer T cells to specifically recognize and kill tumors in patients that express HPV16 proteins. The clinical results obtained in anal, cervical, head and neck, vaginal and vulvar cancers suggest that the preliminary efficacy that's been observed is independent of the type of cancer or its anatomic location. so long as the cancer meets the target molecular profile of HPV16 expression. We are hopeful that pending the updated results of the study, that PDS, NCI, and Merck KGAA will initiate discussions with the FDA on the expected clinical and regulatory strategy for a pivotal phase three trial and eventual regulatory approval pathway for the combination. The VERSATILE-002 Phase II clinical trial is studying PDS-0101 in combination with US Merck's checkpoint inhibitor Keytruda, also known as pembrolizumab, in patients with HPV-16 positive recurrent and or metastatic head and neck cancer. The two study groups include checkpoint-naive patients and checkpoint-refractory patients. This past year, we successfully achieved the first safety benchmark in the checkpoint inhibitor naive arm of the trial, which allowed the study to advance to full enrollment. We have since announced updated safety data from 18 patients in the CPI naive group. These data were presented at the multidisciplinary head and neck cancer symposium in February and demonstrated that the combination treatment was well tolerated without evidence of enhanced or significant toxicity. Accrual has progressed to stage two for the CPI-naive cohort and is ongoing in stage one for the CPI-refractory cohort. More recently, we released preliminary efficacy data from this same group of 18 CPI-naive patients. The Simon two-stage clinical trial design requires the achievement of an objective response as measured by radiographic tumor responses according to Resist 1.1. This response requires a tumor reduction of 30% or more that is confirmed by two separate measurements among at least four or more of the first 17 patients in the CPI-naive arm. Achievement of this milestone allowed for progression to full enrollment of the CPI-naive cohort with a target total of 54 patients. We expect that more mature results will be presented at a medical conference late this year. In parallel, we are enrolling into the CPI refractory cohort of the trial. This cohort is similarly being evaluated using assignment two stage design. In this cohort, we have to achieve an objective response in two out of the first 21 patients to proceed to full enrollment of the cohort with a targeted total of 41 patients. Our third PDS-0101 trial is the ImmunoServe trial, a phase two investigator-initiated trial sponsored by MD Anderson to evaluate PDS-0101 in combination with chemoradiotherapy in patients with locally advanced cervical cancer. As we briefly discussed on our last call, One of the more interesting aspects of this trial is that we'll be collecting both systemic and tumor-specific biomarker data. This may help further elucidate understanding the immune response to the verse immune-based immunotherapies and how early biomarkers may correlate with clinical response. Preliminary results from ImmunoServe are still anticipated in mid-2022. If this trial is successful, it could support further investigation of diverse immune-based immunotherapies with chemotherapy or chemoradiotherapy to treat multiple cancers. The fourth Phase II trial of PDS-0101 is being led by the Mayo Clinic. This trial is evaluating PDS-0101 alone or PDS-0101 with Keytruda in the neoadjuvant treatment of patients with oropharyngeal cancer or prior to transoral robotic surgery. We believe this study will provide invaluable data regarding potential expansion of the versus immune-based immunotherapies into early stage cancer. This trial is now open to enrolling patients. Lastly, before passing it over to Matt, I'd like to briefly focus on our infect immune-based infectious disease preclinical pipeline. Our universal flu vaccine program, PDS0202, is being developed in partnership with the NIAID Division of the NIH. This vaccine is being designed to protect against multiple strains of the flu and combines our infectimmune technology with novel computationally optimized broadly reactive antigens known as COBRA. that have been designed by renowned influenza expert at the University of Georgia, Dr. Ted Ross. The antigens were selected following successful preclinical development work completed under a grant from the NIAID's Collaborative Influenza Vaccine Innovation Centers, or CIVIX program, to progress the development of PDS0202. Preclinical studies demonstrated the ability of PDS-0202 to generate high levels of flu-specific neutralizing antibodies, CD4 helper, and CD8 killer T cells, as well as long-acting memory T cells to potentially provide broad and long-term protection against multiple influenza strains. What has been demonstrated in preclinical studies that without infectimmune, there is ineffective neutralization of any viral strain. The preclinical data suggests that with infectimmune, the effective delivery of flu proteins activate the critical immune signals necessary to generate powerful neutralizing antibody responses to all of the flu strains that were tested. This is a very important and highly encouraging result. It was also important to study the ability of PDS0202 to protect from influenza infection. In standardized influenza challenge studies, a control group were administered a vaccine that had no flu protein. When they were challenged with the H1N1 flu strain, they all died. The second group of mice received a dose of the novel flu proteins, but without infectimmune. All animals got sick. and only 30% survived. However, in the mice vaccinated with PDS-0202, 100% of the animals were completely protected and stayed healthy. This was the case even using a low dose of PDS-0202, which contains 25-fold less flu protein. These studies strongly suggest that a universal flu vaccine is possible PDS Biotech hopes to progress the PDS-0202 vaccine into clinical development in collaboration with the Civics Program Network. The data from these preclinical studies are being prepared for submission to a peer-reviewed journal for publication. With that, I'll now turn it over to Matt for a review of our financial results. Matt?
spk07: Thank you, Lauren. First, I want to thank our shareholders for your patience with the rescheduling of our earnings call. Our auditors needed more time to complete their procedures and in order to give them that time, it made sense to reschedule this call to today. With that, let's move to the financial discussion. For the year ended December 31, 2021, the net loss was approximately $16.9 million or 66 cents per basic and diluted share compared to a net loss of approximately 14.8 million or 89 cents per basic and diluted share for the year ended December 31, 2020. As of December 31, 2021, PDS Biotech had 28.4 million common shares outstanding and 31.8 million common shares outstanding on a fully diluted basis. For the year ended December 31, 2021, research and development expenses increased to approximately $11.3 million compared to approximately $7.9 million for the year ended December 31, 2020. The increase of $3.4 million was primarily attributable to an increase in regulatory and clinical costs of $2.6 million, non-cash stock-based compensation of $1.1 million, personnel costs of $0.4 million, partially offset by an overall decrease in manufacturing and facility costs of $0.7 million. For the year ended December 31, 2021, general and administrative expenses increased to approximately $10.2 million compared to approximately $7 million for the year ended December 31, 2020. The $3.2 million increase was primarily attributable to an increase in personnel costs of $1 million, non-cash stock-based compensation of $2.5 million, and facility costs of $.1 million. partially offset by a decrease in professional fees of $0.4 million. Total operating expenses for the year ended December 31, 2021 were approximately $21.4 million, an increase of approximately 44% compared to a total operating expenses of approximately $14.9 million for the year ended December 31, 2020. The company's cash balance as of December 31, 2021 was $65.2 million. Based on the company's available cash resources and cash flow projections, the company believes this balance is sufficient to fund the company operations and research and development programs through the end of 2023. With that, why don't we open it up to questions? Operator?
spk05: Thank you. And I'll be conducting a question and answer session. If you'd like to be placed into question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing star one. One moment please while we poll for questions. Our first question today is coming from Louise Chen from Cantor Fitzgerald. Your line is now live.
spk01: Hi, congratulations on all the progress over the quarter and thanks for taking my questions here. My first question for you is if you could provide more color on the new adjuvant opportunity for PDS 0101. Is this part of that $5 to $6 billion that you mentioned earlier in the call, or is this on top of that? And the second question I had for you was on your flu platform, impressive data, but I'm curious why you have confidence that you can move forward with your platform here while others or many others have actually failed. And then last question I had for you was if you could provide an update on your MUC1 and TARP programs. Thank you.
spk08: Luis, thank you very much for that question. Or those questions, rather. So let's start with the Mayo program. So if you notice with our PDS0101 programs, PDS0101 is really designed to be a real demonstration program for the company. And you'll notice that we have started with the very late stage cancer patients who have failed all treatment options. And those are the checkpoint inhibitor refractory patients. We're also doing trials in patients who have failed other options, but not yet checkpoint inhibitors, the checkpoint inhibitor naive population. And then with the cervical cancer trial led by MD Anderson, we're then looking at pre-metastatic cancer, so locally advanced. And the Mayo trial gets us even earlier. So the strategy here is to cover the entire breadth of indications. And also, when you look at the NCI trial, we're not only looking at a specific type of cancer, we're looking at all types of HPV-associated cancers. And the early data has suggested that the biomarker approach or the molecularly targeted approach is potentially viable for this program. So really the strategy here with PDS 0101 is to provide or attain as much coverage in this $5 to $6 billion U.S. market as commercially feasible, right, to demonstrate potential security or to demonstrate security, period, if we can achieve that across board and for this range of broad range of HPV-associated cancers. And all these are incorporated within that $5 to $6 billion market. So that's really the strategy here, seeing very promising data with the late-stage cancer programs, seeing potentially good safety, and therefore now coming earlier and earlier in the cancer stage. So moving on from there to the infectimmune program and the universal flu. So with universal flu, the approach that has typically been taken has been to include probably two or three or three or four different strains of the flu virus into the formulation of the vaccine itself, right, in order to generate immune responses against those specific strains of the virus that are incorporated in the vaccine. And typically the focus has been antibody responses. However, the approach that we are taking is slightly different. And so what Dr. Ted Ross at the University of Georgia has done is he has come up with a very different approach, which is not taking the specific viruses, but actually utilizing a computer-designed approach, what he calls the computationally designed proteins, where he has looked at strains of these viruses over the last couple of decades and really designed these programs to incorporate immunogenic regions from these strains over the last couple of decades. And so with this novel approach, we are hopeful that we can induce broadly reactive immune responses. And very importantly, with our approach, we are not only dealing with antibody responses, we're also dealing with T-cell responses. And we have confirmed, so our early preclinical studies or the preclinical studies that we just completed demonstrate that if you take those broadly reactive proteins, the computationally designed proteins, you can generate neutralizing antibody responses against a broad range of strains. However, the neutralization levels don't reach what we would typically want to see in an effective vaccine, flu vaccine. However, when we take those same proteins and combine them with our infect immune platform, At that point, you get highly effective presentation into the right pathways and activation of the right signals, immunological signals, to generate really powerful neutralizing responses. And we see the protection too in the preclinical studies. And so this is really the unique approach we take and where we are not saying we're going to incorporate specific strains, but this computationally designed protein, which should cover a number of immunogenic regions from multiple strains of these viruses over the last couple of decades, we believe provides a different approach, but strongly and potentially effective based upon the results we've seen to date. And we are hopeful that we will be able to take these into human clinical trials and really demonstrate not only strong neutralizing antibodies, but we believe the long-term protection also depends quite a bit on being able to induce the right kinds of T cell responses, the memory T cell responses, which could also help provide that durability of that immune response and provide the long protection. So that's how what we're doing differs, and that's why we have a high confidence of being successful with this approach. And then moving on to PDS-0102 and PDS-0103. With PDS-0103, we're actually in manufacturing, clinical manufacturing now, and PDS-0102 is also in the manufacturing process. We have limited resources, and what we're doing here, what we decided to do was to capitalize on the opportunity with PDS-0101 to go into the earlier stage disease cancer disease with the mayo clinic and so based upon that what we said was let's replace pds0102 with pds0101 for this year right and then progress pds0103 into the clinic hopefully by the end of this year and then the goal is hopefully to follow that up with pds0102 which is actually also going through the manufacturing process but both of those programs have completed pre-clinical studies we've demonstrated very similar types of CD8 T-cell responses as we have demonstrated with PDS-0101. And so with both programs, we're also very hopeful that we'll be able to take a very similar approach looking at these molecularly targeted approaches to immunotherapy with PDS-0102, as Lauren said, prostate, breast, and AML. And with PDS-0103, we'll also start the program looking at multiple types of cancer to really understand how that works across board with those Mach 1 positive cancers. So, Louise, I hope this answered your questions. Was there anything I left out?
spk01: No, that was great. Thank you very much.
spk08: You're welcome.
spk05: Thank you. Our next question is coming from Leland Gershall from Oppenheimer. Your line is now live.
spk06: Hey, good morning, Frank and Lauren. Thank you very much for the comprehensive update. A couple of questions for me. First, with respect to the recent rise in incidence of HPV-driven cancers, you know, clearly with HPV vaccines, you know, some may expect those rates to go down. Perhaps those are only, you know, active toward, you know, cervical HPV cancers and not others. Perhaps, Frank or Lauren, you could, you know, delve into that dynamic a bit more for us. And then secondly, you know, with respect to kind of the cadence of trial data reveals, particularly with regard to the NCI triple combo trial, you know, perhaps you can share with us kind of the process in which decisions are made as to when to release data and who's really in charge of making those decisions. Thank you.
spk08: Okay. So, Leland, thanks a lot for those questions. So, I'm going to start answering, Lauren, regarding the HPV market and the HPV disease, and you can jump in with any additional comments once I go through the first set of answers. But, Leland, with the HPV-associated disease, one of the key things is that's important in terms of the presence of these preventive vaccines out there today and what impact they could potentially have on the markets. Now, there has been a lot of epidemiology work done, and there are a number of reasons that have been presented as to why some of these incidences are still on a significant rise and increase, for example, head and neck cancer. And the reason for this is the current vaccines are only preventive in nature. And they're only effective if those vaccines are administered before the patient is actually infected with the virus. And as we know, the HPV is the most prevalent sexually transmitted agent worldwide today. So it's very highly prevalent. And these vaccines are active only if they're given ahead of that infection. Secondly, these are very slowly progressing cancers, right? And so sometimes it's been reported that these could take even a couple of decades from the time of infection to the time of actually getting the cancer. So those are very important in terms of the incidences. And so what has been projected is that based upon these critical factors, where the current vaccines are only effective before infection and the very high rates of infection, that very likely most of the patients we will be treating over the next 20 or so years have already been infected with the virus, and people are still getting infected with this virus. And so head and neck cancer is a really good example where the incidences of head and neck cancer are rising significantly, and it has actually been described as a silent epidemic. And the vast majority of these cases are HPV-positive head and neck cancer cases. And so there's still a very significant unmet medical need to address these very debilitating cancers, which in many cases, head and neck, for example, and anal, are on a significant rise in incidences over the last couple of years. The last several years, rather. So moving from there onto the timing of our data releases, mean that's something that we have considered quite a bit and very seriously and we we strongly believe that it is in the best interest of the company and our shareholders for our early data to be critically peer-reviewed by experts and presented at leading oncology conferences right and to meet this bar requires that the study be done with a certain amount of scientific and clinical rigor right this also allows us to reach a much broader and highly relevant audience in addition to our shareholders. So this is what we've recently done, for example, with the safety results from the Versatile 002 study. Unfortunately, for many such conferences, making the data public precludes us from being able to present the data at the conference. So this is a really good question. As I imagine, many shareholders and prospective investors based upon our early promising data are anxious to learn more. And so we anticipate presenting the data at a conference in late Q2 or early Q3.
spk06: Great. Okay, that's very helpful. Thank you very much. You're welcome.
spk05: Thank you. Our next question today is coming from Jim Malloy from Alliance Global. Your line is now live.
spk04: Hey, guys. Thanks for taking my questions. looking at the expected timing for the triple combination with Ventra, next interim look there. And I want to make sure I understood the correct timing on the versatile 002 combo with Keytruda for the next interim look. And then I think it mentioned in the past or indicated in the past that you're likely to be partnering, particularly with the triple combo, for phase threes and launches. Can you talk a little bit about the partnering environment and, you know, given... The data is looking good, but it's still pretty early. How does the partnering environment look at this point?
spk08: Jim, thanks a lot for your question. So in terms of the data, presenting the data, and we anticipate that this would be at a conference either late Q2 or early Q3. And in terms of the, for the NCI trial, the triple combination, we're looking at two specific groups of data, right, in terms of the data on the patients The patients whose data was presented at ASCO last year, how have those patients fared over that period, over the year since ASCO to date? And also, what does the new patient's data look like compared to those patients whose data was presented at ASCO? So essentially, what is the durability of these immune responses and what efficacy is it holding up, similar to what we saw at ASCO last year? And so that we are hopeful that we will be able to present that data probably late Q2. And the same with the Versatile 002, we provided the top-line data in terms of meeting that critical milestone of how many patients for at least four or more to progress this into full enrollment. We are hopeful that we should be able to, at the conference again, either late Q2, early Q3, present more details on these results in terms of the objective response rates, the overall survival rates, progression-free survival, in addition to the safety data that has already been presented, so provide more in-depth. analysis of the data that has been generated to date. And so the way we look at this is the PDSO 101 studies, hopefully Q2, Q3, if we are able to achieve these goals, will provide very solid proof of concept for the versatile platform. And so that's really the key goal with PDSO 101. As I said, it's the demonstration program to provide us with that solid proof of concept of being able to generate these antigen-specific powerful killer T-cells in vivo. Now, as you know, a lot of these T-cell activating approaches haven't really been successful over the last decade since Provenge, for example. We haven't had any FDA approvals. And so we believe that in order for us to successfully execute the next phase of our business program, is going to require the solid proof of concept, which we are hoping we will be able to achieve by Q2, Q3, that will allow us to then start having very serious partnering conversations with prospective investors and partners to expand our programs and to partner to go into the other platform programs also. But in terms of timing, once the data becomes available Q2, Q3, what we intend to do is to then sit down and start having these discussions with the FDA and with our partners in terms of what would be the most rapid approaches to getting these through the pivotal trials into commercialization. And strategically, how can we do this most efficiently? But we believe that being able to achieve the goal that we've set for Q2, Q3, which we are hopeful that we should be able to meet, would then be critical in executing the second phase, whether it's going into pivotal trials, deciding how we do that, also initiating discussions with potential partners moving forward. Jim, I hope that answered your question.
spk04: It did indeed. It did indeed. Thank you. And maybe a quick follow-up on the COVID program. I know that You know, COVID has been waning in the U.S., particularly throughout the world. There's, you know, VA2 variants out there. And I guess I think you and I have spoken. There's no hard and fast rule that the next variants must be less deadly. This happened to have been the last couple times. How do you see the – have you seen a waning of interest in the COVID program? Or what are your thoughts on, you know, the fact that this – the U.S. may be done with COVID, but COVID is certainly not done with the U.S.? ?
spk08: Yeah, so, I mean, that's a tough one. But I think, I mean, the way things are progressing with COVID, if you listen to the experts, most of the experts believe that this is probably going to be with us for the long term and that we're probably going to have to be getting vaccinations on a regular basis. And I think the way we are looking at this is what are the opportunities today in the COVID-19 space? And very likely, we think it's a couple of things. Safety, robustness, and durability of the immune response, meaning can a vaccine be developed that provides long-term protection, so for at least a year, right? And can we also induce the kinds of immune responses that provide robust protection against multiple strains of COVID-19? And based upon what the experts are projecting in terms of how long COVID is going to be here, we believe that if a vaccine can be developed that meets these characteristics, right? Long-term protection, maybe a year or so, and also broader protection in terms of protecting against multiple strains, that there is very strong potential for that vaccine to be a commercially successful vaccine, right? And to be able to do that, we believe that T cell response, in addition to strong neutralizing antibodies, provides that potential to do this successfully. And so based upon that, and also based upon the fact that we are really not committing any of our resources to doing that, and that's really being done by our partner in Brazil, who appear to be making some good progress, right? So we've been in touch with them, as we mentioned. We are going to revisit that program by the end of May. We gave them extension through end of May. And so we will be revisiting that, looking at their progress and making a decision on at that point, but they are making progress, and we do believe that there is still a commercial opportunity for a vaccine that can be differentiated in terms of safety, durability, and breadth of response.
spk04: Great. Thank you for taking the questions.
spk08: You're welcome.
spk05: Thank you. Our next question is coming from Joe Pangenis from HC Wainwright. Your line is now live.
spk03: Hi. Good morning, everybody. I wanted to focus my question more on the macro components of flu right now, but obviously with a focus on 0202 obvious as well. So, you know, do you feel that there can be an increased focus now or, you know, coming off a season where the current flu vaccine, really the data show that the efficacy was much lower because the predictions weren't there because flu hadn't been around? Do you feel that that can create you know, increased focus and the desire for a universal flu vaccine, even though, you know, these approaches have been around for quite some time?
spk08: Well, Joe, you make a very good point that these approaches have been around for quite some time, right? So, I think for at least a decade, there has been a lot of interest in developing a universal flu vaccine. I think with what's happened with COVID-19 and the rapid mutations, I think it has brought into focus a little bit more the potential for pandemic flu, for example. Now, whether there is going to be more interest dedicated to this by some of those agencies, the governmental agencies or not, that's really difficult to say. But I think based upon what we've seen, for example, our program, as we mentioned, is funded by the NIAID. We are hopeful that we will be able to get the funding to take it into human clinical trials, hopefully by the end of the year or early next year. And I think it will be important there to be able to translate the preclinical data into human data. And I think that will be very, very important in being able to demonstrate the potential to do this. But there has been a lot of interest just based upon the very low reported efficacy of the flu vaccine from season to season to be able to have something that's a little bit more effective and durable. And I'll actually ask Lauren to add if there's anything Lauren wants to add to this.
spk02: Thanks, Frank. And thanks, Joe, for that question. I think everyone is aware of the fact that depending on which respiratory viruses may be predominating at certain seasons, you then see impacts on other viral infections. So during the last two years, we've had a predominance and a focus on SARS-CoV-2, and we saw lower incidences of flu and RSV. Again, as SARS-CoV-2 now starts to recede, we're starting to see flu as well as RSV cases come up. Ultimately, people are believing that hopefully SARS-CoV-2 may become an endemic virus, which is going to still have the need because of its mutability to have an effective vaccination that addresses it. We now have flu that is highly mutating and seasonal, as well as potentially ongoing different waves of SARS-CoV-2. And because of that, I think you're actually seeing in the sector the fact that individuals are still trying to address coming up with vaccine approaches that would be broadly reactive, universal vaccines for not only flu, but also for COVID. And you're seeing attempts at developing dual agent vaccines that would protect against both flu as well as COVID at the same time. So, there is going to unquestionably be need. There is unquestionably interest. And again, as Frank has highlighted during the call, I think what's differentiating about the infecting in base platform with the flu Cobra antigen from the University of Georgia that Ted Ross has developed is we not only see neutralizing antibody responses, which is the end all be all historically of infectious disease vaccines. But we are also seeing the development of those T cell responses which have the opportunity to provide long-term memory and potentially greater duration of protection. Right now, it's looking like everybody is going to need COVID boosters every six months. So, prolonging duration of protection so that vaccines can be delivered
spk03: once a year or longer as well as having broad protection across a range of viral strains and species is going to be very critical for both flu and for covid that makes sense i appreciate that color so maybe i'll just take it one more step because the way frank put it um you know currently the hope is you know in order to get it in to the clinic or you know with getting it into the clinic you know you would like to still have your collaboration with the NIAID, but maybe you could talk to your flexibility and or optionality that also brings Matt into the conversation since he is controlling your guys' checking accounts. So with regard to maybe looking for external funding, something like the Gates Foundation or anything along those lines, or what you might want to or not want to throw behind it with company-based funding.
spk08: No, I think to date, and I'll let Matt also join in, but we have all options on the table in terms of partnering and looking at other non-dilutive options. But at the moment, we're not seeking to utilize any of our current cash in progressing that program at this point. Matt, do you want to join in?
spk07: Yeah, absolutely. Joe, that's a great question. When we look at the size of the markets currently in oncology, you know, 5 to 6 billion in HPV-related cancers, over 40 million, over, you know, another 100 million when you get to MUC1 in the potential total available markets, we're focusing our dollars right now on the oncology, immuno-oncology markets. And we're seeking non-dilutive financing to assist us with the infectious disease, which is why we went with Pharmacore originally, and we're working with Dr. Ross on evaluating all aspects to help us get the universal flu vaccine into the clinic as quickly as possible.
spk03: Thank you, guys.
spk05: Thank you. As a reminder, that's star one to be placed in the question queue. Our next question today is coming from Robert LaBoyer from Noble Capital. Your line is now live.
spk09: Good morning. My question has to do with the universal flu vaccine, and Dr. Beto Addo gave a very nice description earlier in the call. I was wondering if it's appropriate to discuss the actual targets in the virus that the vaccine would be directed against. as well as if you're seeing any data that would predict the duration of this response, whether it's going to be one season, multiple seasons, or potentially many years.
spk08: Hi, Robert. Thanks a lot for the question. I'll start and then I'll have Lauren to jump in. So the way Dr. Ross has designed these computational proteins is he's looked at multiple strains of the seasonal flu as well as multiple strains of the pandemic flu strains. And so he has a number of proteins that are designed to either focus on the seasonal flu strains as well as the pandemic flu strains. And so we have currently focused our initial studies on the seasonal flu strains but we'll very likely consider moving also to the pandemic flu strains once we've demonstrated transition of the results we have in preclinical to human clinical results. In terms of the durability of those responses, it's very difficult to predict. They have to actually be studied in humans, and that's why we are anxious to be able to get into humans and begin to understand exactly what the durability of those responses could potentially be in humans. But I think it is promising considering the fact, as Lauren said, the induction of those T cell responses and memory T cell responses are a really good indicator of the potential durability of that vaccine and the protective responses that could be generated. But I think we will have to actually study it in a human clinical trial. Lauren, any additional comments?
spk02: Yes. And the things that I would add is that regarding in addition to the testing that ultimately needs to be done in humans, when you get to assessing the durability of the response and the breadth of the response against different flu strains, I think what Frank has previously highlighted during our call is what we have demonstrated preliminarily to date so far by co-delivering infectamines with Dr. Ross's broadly reactive antigens. that, again, are designed to induce immune responses across a broad range of strains of flu that have been detected over the years. What appears to be differentiating is we not only see the neutralizing antibody responses that have historically been associated with all flu vaccines, but we are also seeing the induction of T-cell specific responses, both CD8 and CD4 T-cell responses to these flu antigens. And this ultimately may be what is differentiating about the Cobra antigens in terms of their broad reactivity, but their co-delivery with infectamines. The preclinical animal challenge studies certainly suggest that, but again, the definitive bar is going to be progression to testing in human clinical trials. We also are in the process of submitting a publication detailing the immune responses induced by Infectimmune co-delivered with the flu antigens in PDS0202, as well as with SARS-CoV-2 antigens. And that, we hope to have that in publication before the end of the year, but that is being submitted for peer review.
spk09: Okay, great. Thank you very much, and thanks for taking my question. You're welcome.
spk05: Thank you. We reached the end of our question and answer session. I'd like to turn the floor back over to Frank for any further or closing comments.
spk08: Thank you very much. Again, thank you very much for joining us today. Our goal at PDS Biotech is to be able to rapidly provide better therapeutic options to cancer patients and to fulfill a severe unmet medical need to offer effective treatments with extended survival to advanced cancer patients. If successful, we are optimistic this could provide renewed hope to patients and their families. We look ahead to the rest of 2022 as we continue to advance our growing pipeline of promising oncology and infectious disease candidates. Thank you very much again, and have a great rest of the day. Thank you.
spk05: Thank you. That does conclude today's teleconference and webcast. You may disconnect your line at this time and have a wonderful day. We thank you for your participation today.
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