PDS Biotechnology Corp Q4 FY2021 Earnings Call

Greetings and welcome to PDS Biotechnology Fourth Quarter 2021 Earnings Call and Webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to turn the conference over to Gabby DeGravina. Please go ahead.

Good morning. And welcome to PDS Biotechnology's fourth quarter and full-year 2021 earnings conference call and audio webcast. With me today from the company 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 and year ended December 31, 2021. We encourage everyone to read the press release as well as PDS Biotech's report on Form 10-K, which was filed with the SEC earlier this morning. The company's press release is available on the PDS website at pdsbiotech.com and the 10-K should be posted later today. In addition, this conference call is being webcast and will be archived on the company website for future reference. Before we begin, we need to remind everyone that, on today's call, the company will be making forward-looking statements regarding regulatory and product candidate development plans, as well as research activities. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in the PDS Biotech's most recent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Except to the extent required by applicable law or regulation, PDS Biotech undertakes no obligation to update the forward-looking statements included today to reflect subsequent events or circumstances. With that, I would now like to turn the call over to Dr. Frank Bedu-Addo and Lauren Wood.

Thank you, Gabby. And thanks to all of you for joining us this morning. We have undergone a period of incredible productivity and progress here at PDS Biotechnology, and I would like to share some highlights from the past year as well as our more recent progress. The National Cancer Institute, NCI, presented promising preliminary safety and efficacy data from the first 18 subjects in the triple combination trial at the American Society of Clinical Oncology, ASCO, Meeting in June of 2021. This preliminary data demonstrated the potential to provide clinical benefits and extension of life in the majority of patients with advanced HPV associated cancers who have failed all treatment options. The NCI achieved their target recruitment of 30 patients in the checkpoint inhibitor refractory arm this quarter and 45 patients in total have been enrolled to date. In Q2 and Q3, we hope to have additional efficacy updates for this trial presented at a leading peer-reviewed clinical conference. The PDS Biotech-led VERSATILE-002 trial is evaluating PDS0101 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-naïve 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 PDS0101 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 the new PDS0101 trial to be led by Mayo Clinic. This trial is studying the use of PDS0101 with and without Keytruda as a potential new adjuvant treatment for oral cancer and is 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 PDS0101. 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 billion to $6 billion US market. PDS0102 addresses cancers containing a protein we call TARP, 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, which is an approximately $45 billion addressable market. PDS0103 addresses cancers containing a protein called MUC-1. These include colon, breast, ovarian, and lung cancers, another very significant market opportunity. We anticipate initiating clinical evaluation of PDS0103 during the second half of this year. I will briefly discuss our infectious disease pipeline. These products are based on our Infectimune 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 Infectimune with novel computationally-designed proteins that were developed by Dr. Ted Ross, the world-renowned flu expert. This program is funded by the National Institute 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 Infectimune 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 Farmacore for Latin America. We expect that the strong neutralizing antibody and CD8 T cell activating vaccine may produce more durable or longer protection against multiple strains of the virus. Farmacore 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 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, we strengthened our corporate leadership, adding distinguished immune 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 Infectimune, 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 immuno-oncology. The ability to induce T cells in vivo is neither novel nor unique. What is, however, unique about Versamune 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 cells – 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.

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 PDS0101 in combination with both bintrafusp alfa or bintra for short, and M9241, also known as NHS-IL12, 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-naïve 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 31, 2021, 30 patients who are HPV16 positive had at least one evaluation. There's currently about a 3 to 1 ratio of CPI refractory patients to CPI-naïve 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-naïve patients historically have a median survival of 7 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 31, 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-naïve and CPI refractory, experienced 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 targets for PDS0101. The contracting tumor treatment 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, PDS, NCI and Merck KGaA will initiate discussions with the FDA on the expected clinical and regulatory strategy for a pivotal Phase III trial and eventual regulatory approval pathway for the combination. The VERSATILE-002 Phase II clinical trial is studying PDS0101 in combination with US Merck's checkpoint inhibitor Keytruda, also known as pembrolizumab, in patients with HPV16 positive recurrent and or metastatic head and neck cancer. The two study groups include checkpoint-naïve patients and checkpoint refractory patients. This past year, we successfully achieved the first safety benchmark in the checkpoint inhibitor naïve 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-naïve 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. The study has progressed to stage two for the CPI-naïve 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-naïve patients. The Simon two-stage clinical trial design requires the achievement of an objective response, as measured by radiographic tumor responses according to RECIST 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-naïve arm. Achievement of this milestone allowed for progression to full enrollment of the CPI-naïve 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 a Simon two-stage design. In this cohort, we have to achieve an objective response in 2 out of the first 21 patients to proceed to full enrollment of the cohort with a targeted total of 41 patients. Our third PDS0101 trial is the IMMUNOCERV trial, a Phase II investigator-initiated trial sponsored by MD Anderson to evaluate PDS0101 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 Versamune-based immunotherapies and how early biomarkers may correlate with clinical response. Preliminary results from IMMUNOCERV are still anticipated in mid-2022. If this trial is successful, it could support further investigation of the Versamune based immunotherapies with chemotherapy or chemoradiotherapy to treat multiple cancers. The fourth Phase II trial of PDS0101 is being led by the Mayo Clinic. This trial is evaluating PDS0101 alone or PDS0101 with Keytruda in the neoadjuvant treatment of patients with oral pharyngeal cancer prior to transoral robotic surgery. We believe this study will provide invaluable data regarding potential expansion of the Versamune-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 Infectimune-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 Infectimune 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 CIVICs program, to progress the development of PDS0202. Preclinical studies demonstrated the ability of PDS0202 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 is that, without Infectimune, there is ineffective neutralization of any viral strain. The preclinical data suggests that, with Infectimune, the effective delivery of flu proteins activates 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 challenged studies, a control group was 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 Infectimune. All animals got sick and only 30% survived. However, in the mice vaccinated with PDS0202, 100% of the animals were completely protected and stayed healthy. This was the case even using a low dose of PDS0202, which contains 25-fold less flu protein. These studies strongly suggest that a universal flu vaccine is possible. PDS Biotech hopes to progress the PDS0202 vaccine into clinical development in collaboration with the CIVICs program network. 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.

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 the 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 $0.66 per basic and diluted share compared to a net loss of approximately $14.8 million or $0.89 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, and personnel costs of $0.4 million, partially offset by the 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 $0.1 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 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 that 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?

Our first question today comes from Louise Chen from Cantor Fitzgerald.

Congratulations on all the progress over the quarter. My first question for you is if you could provide more color on the new adjuvant opportunity for PDS0101. Is this part of that $5 billion to $6 billion that you mentioned earlier in the call? Or is this on top of that? And the second question I have for you is on your flu platform, impressive data. But I'm curious why you have confidence that you can move forward with your platform here, while many others have actually failed. And then, last question I had for you was if you could provide an update on your MUC-1 and TARP program.

Let's start with the Mayo program. So, if you notice, with our PDS0101 programs, PDS0101 is really designed to be a true demonstration program for the company. You'll notice that we have started with the very late-stage cancer patients who have failed all treatment options. Those are the checkpoint inhibitor refractory patients. We're also doing trials in patients who have failed other options, but have not yet received checkpoint inhibitors, the checkpoint inhibitor-naïve population. Then, with the cervical cancer trial led by MD Anderson, we are looking at pre-metastatic cancer, so locally advanced. The Mayo trial gets us even earlier. The strategy here is to cover the entire breadth of indications. When you look at the NCI trial, we're not only focusing on a specific type of cancer; we're examining all types of HPV associated cancers. Early data has suggested that the biomarker approach or the molecularly targeted approach is potentially viable for this program. The strategy with PDS0101 is to provide or obtain as much coverage in the $5 billion to $6 billion US market as commercially feasible to demonstrate potential superiority or provide superiority—period—if we can achieve that across the board and for this broad range of HPV associated cancers. All these things are incorporated within that $5 billion to $6 billion market. So, that's really the strategy here, and we are seeing very promising data with the late-stage cancer programs, seeing potentially good safety, and thus now moving earlier and earlier in the cancer stage. Moving on from there to the Infectimune program and the universal flu. So, with universal flu, the approach that has typically been taken has been to include two or three, maybe three or four different strains of the flu virus into the formulation of the vaccine itself to generate immune responses against those specific strains of the virus included in the vaccine. The focus hasn't typically been on antibody responses. However, the approach we're taking is slightly different. Dr. Ted Ross at the University of Georgia has developed a novel approach which does not incorporate specific viruses, but instead utilizes a computer-designed approach. He has examined strings of these viruses over the last couple of decades and adapted these programs to include immunogenic regions from multiple strains. With our approach, we are hopeful to induce broadly reactive immune responses. Very importantly, we are not only dealing with antibody responses, but also T cell responses. Our early preclinical studies 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, those neutralization levels do not reach the efficacy we would usually want to see in an effective flu vaccine. When we pair those same proteins with our Infectimune platform, you can achieve highly effective presentation into the right pathways and activate the appropriate immunological signals to generate powerful neutralizing responses. Therefore, we see protective outcomes in preclinical studies. This is the unique approach we are taking. We are not claiming we will incorporate specific strains, but this computationally-designed protein, which covers numerous immunogenic regions from multiple strains over the last several decades, provides a different approach that is strongly and potentially highly effective based upon current results. We hope to take these into human clinical trials to demonstrate not only strong neutralizing antibodies but also the importance of inducing the right T cell responses that can lead to long-lasting protection.

Our next question is coming from Leland Gershell from Oppenheimer.

A couple of questions for me. First, with respect to the recent rise in the incidence of HPV driven cancers, clearly, with HPV vaccines, some may expect those rates to go down, perhaps those are only active toward cervical HPV cancers and not others. Perhaps, Frank or Lauren, you could delve into that dynamic a bit more for us. And then secondly, with respect to the cadence of trial data revealed, particularly concerning the NCI triple combo trial, maybe perhaps you can share with us the process in which decisions are made as to when to release data and who's really in charge of making those decisions.

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 with the HPV associated disease, one of the key things is the presence of these preventive vaccines. There has been a lot of epidemiology work done, and multiple reasons are presented as to why some of these incidences are still on a significant rise, including an increase in head and neck cancer. The reason is that the current vaccines are only preventive in nature and are effective only if administered before the patient is infected with the virus. HPV is the most prevalent sexually transmitted agent worldwide today, so it is extremely common, and the vaccines are only active if given ahead of that infection. Moreover, these are slowly progressing cancers, and it's reported that it can take decades from the time of infection to the time of actually developing cancer. Projections indicate that most patients we will be treating over the next twenty years have already been infected with the virus, with current infection rates continuing. Head and neck cancer exemplifies this issue, as incidences of HPV positive head and neck cancer are rising significantly and have been referred to as a silent epidemic. The majority of these cases are HPV positive head and neck cancer cases, indicating a significant unmet medical need to address these debilitating cancers, especially as incidents of anal and other HPV associated cancers have also seen a significant rise in incidences. Moving on to data releases, this is a critical consideration for us. We strongly believe that it is in the best interest of the company and our shareholders for early data to be critically peer-reviewed by experts and presented at leading oncology conferences. Meeting these high standards requires that the study be performed with a certain degree of clinical and scientific rigor. Additionally, this allows us to reach a broader, highly relevant audience beyond our shareholders. This is something we have recently done, for example, with the safety results from the VERSATILE-002 study. Unfortunately, for many such conferences, making the data public beforehand precludes us from being able to present at those conferences. This is a crucial point, considering many shareholders and potential investors are eager to learn more based on our promising early data. We anticipate presenting further data at a conference in late Q2 or early Q3.

I had a question on – you're looking at the expected timing for the next – the triple combination bintra interim look there. I want to ensure I understood the correct timing on the VERSATILE-002 combo with Keytruda for the next interim look, and I think you had mentioned in the past or indicated that you're likely to be partnering, particularly the triple combo for Phase IIIs and launches. Can you talk a little bit about the partnering environment? Given the data looks good but is still pretty early, what does the partnering environment look like at this point?

In terms of data presentation, we anticipate this would occur at a conference either late Q2 or early Q3. For the NCI trial, we are looking at two specific data groups: data on patients presented at ASCO last year and how those patients have fared since then, as well as new patient data compared to those ASCO presented. Essentially, we're evaluating the durability of these immune responses and the efficacy—are they holding up similarly to what we observed at ASCO last year? We are hopeful to present that data by late Q2. The same goes for VERSATILE-002; we provided top-line data demonstrating how many patients required to progress into full enrollment. We hope to present more detailed results at the conference around late Q2, early Q3, in terms of objective response rates, overall survival rates, and progression-free survival. Achieving our goals for Q2 or Q3 will provide solid proof of concept for the VERSATILE platform. The PDS0101 studies will, hopefully, yield this solid proof of concept to attract interest from prospective investors and partners to expand our program. Once the data is available, following the Q2 or Q3 timeframe, we intend to discuss with the FDA and potential partners the most rapid approaches for pivotal trials leading to commercialization.

Maybe a quick follow-up on the COVID program. I know that COVID has been waning in the US, particularly throughout the world. There's a BA2 variant out there. There's no hard and fast rule that the next variant must be less deadly. This has happened the last couple of times. Have you seen a waning of interest in the COVID program? What are your thoughts on the fact that this is – while the US may be done with COVID, COVID is certainly not done with the US?

That's a tough question. But the way things are progressing with COVID, if you listen to the experts, most believe that this is likely going to be with us for the long term, and we will have to receive vaccinations regularly. We are evaluating the opportunities present in the COVID-19 space. It seems there are several avenues to explore—safety, robustness, and durability of immune response, can a vaccine be developed that provides long-term protection of at least a year, and can we induce immune responses that offer robust protection against multiple strains. Based on expert projections about COVID's long-term presence, we believe that if a vaccine can be developed with these characteristics, there is tremendous potential for commercial success. Developing that requires a focus on T cell response in addition to robust neutralizing antibody development. We're not committing any of our resources right now, so that's being managed by our partner in Brazil, who is making progress. We plan to revisit that program by the end of May, reviewing their progress and making decisions based on that information.

I wanted to focus my question more on the macro components of flu right now but obviously with a focus on 0202 as well. So, do you feel there can be an increased focus now or coming off a season where the current flu vaccine efficacy was much lower because the predictions weren't accurate due to flu's absence? Do you feel that can create increased focus and the desire for a universal flu vaccine, even though these approaches have been around for quite some time?

Joe, you make an excellent point that these approaches have been around for quite some time. For at least a decade, there has been an interest in developing a universal flu vaccine. What's happened with COVID-19, with the rapid mutations, has highlighted the potential for pandemic flu. Whether governmental agencies will show more interest in this remains to be seen. Our program, which is funded by the NIAID, is hopeful we can secure funding to move into human clinical trials, possibly by the end of this year or early next year. It will be critical to translate our preclinical data into human data to support that goal. There's been ample interest based on the low reported efficacy of flu vaccines from season to season to develop something more effective and longer-lasting. I'll ask Lauren if she wants to add anything.

Everyone is aware that depending on which respiratory viruses may be predominant certain seasons, you see impacts on other viral infections. During the last two years, we focused on SARS-CoV-2, leading to lower incidences of flu and RSV. Now that SARS-CoV-2 is receding, we're seeing flu and RSV cases return. There’s a prevailing belief that SARS-CoV-2 may become endemic, necessitating effective vaccination able to address the virus's mutability. Flu remains highly mutating and seasonal, as well as COVID potentially. For this reason, the sector is focused on developing broadly reactive, universal vaccines for both flu and COVID. There are even attempts to create dual-agent vaccines that protect against both flu and COVID simultaneously. Undoubtedly, there is a need and interest in these developments. As Frank mentioned, the Infectimune-based platform combined with flu, along with COBRA antigens from Dr. Ross, shows a promising trend towards not only inducing neutralizing antibody responses but also T cell responses, which may provide long-term memory and extended duration of protection. Currently, it appears everyone might need COVID boosters every six months. Therefore, prolonging the duration of protection so that the vaccines could be given once a year or longer while providing broad protection across various viral strains is critical for both flu and COVID.

To follow up based on how Frank phrased it, the hope is to get the clinical development underway, ideally with collaboration from NIAID. Perhaps you can touch on the flexibility or optionality of seeking additional funding sources, perhaps from the Gates Foundation or other avenues, and how that aligns with company-based funding perspectives.

We're exploring all options in terms of partnership and other non-dilutive funding sources. However, at this moment, we're not looking to use any of our current cash to push that program forward.

Absolutely. When we consider the size of markets in oncology—$5 billion to $6 billion in HPV-related cancers and over $40 million, up to $100 million when you factor in MUC-1—the focus of our funding will be in oncology and immuno-oncology. We're seeking non-dilutive financing to support work in infectious disease, which is why we partnered with Farmacore originally and are collaborating with Dr. Ross to find ways to expedite the universal flu vaccine's clinic entry.

My question pertains to the universal flu vaccine. Dr. Bedu-Addo provided an excellent description earlier in the call. I wonder if it’s appropriate to discuss the actual targets in the virus that the vaccine would be directed against and if you're observing any data predicting response duration—whether it might be one season, multiple seasons, or potentially many years.

I'll start and then I'll have Lauren contribute. Dr. Ross designed these computational proteins by examining numerous strains of both seasonal and pandemic flu, creating proteins targeting these strains. We've initially focused our studies on seasonal flu strains, but we might also consider addressing pandemic strains once we've successfully transitioned our preclinical results to human clinical outcomes. Regarding the durability of responses, predicting how long protection might last is difficult; this needs to be tested in humans. But we are optimistic given that our induction of T cell responses and memory T cell responses is a positive indicator of potential durability and protection. Ultimately, these points will need to be established in human clinical trials. Lauren, any additional comments?

In addition to testing in human subjects, evaluating the durability of the response and breadth of activity against different flu strains needs addressing. As previously highlighted, preliminary data suggests that by co-delivering Infectimune with Dr. Ross' broadly reactive antigens—designed to initiate immune responses across multiple flu strains detected historically—we not only demonstrate neutralizing antibody responses, which have traditionally been the focus of all flu vaccines but also induce T cell specific responses for CD8 and CD4 T cells against these flu antigens. This distinction may be critical for broad reactivity when combined with Infectimune. Preclinical animal challenge studies support this notion; however, the definitive determination will come from progressing to human clinical trials. We are submitting a publication shortly that details the immune responses elicited by Infectimune solely when co-delivered with flu antigens in PDS0202 as well as with SARS-CoV-2 antigens for peer review.

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. That does conclude today's teleconference and webcast. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.