PDS Biotechnology Corporation (PDSB) Earnings Call Transcript & Summary

Welcome to the Virtual Roadshow Series presented by Channelchek and NOBLE Capital Markets. Of the 6,000 small and micro-cap companies listed on Channelchek, today we're featuring PDS Biotechnology, NASDAQ ticker symbol PDSB. Research coverage of PDS Biotechnology is provided by NOBLE Capital Markets. NOBLE is a FINRA-licensed SEC-registered broker-dealer. All NOBLE Research is available on Channelchek. Following the formal presentation, Ahu Demir, NOBLE's biotechnology research analyst covering PDS Biotechnology, will ask our presenter a selection of the questions received during the broadcast. And now here is Frank Bedu-Addo, CEO of PDS Biotechnology to make a presentation. Frank, take it away.

Well, thank you very much for the introduction. And so today, I would like to present PDS Biotechnology. And to the audience, please be aware that the presentation contains forward-looking statements about the company. Please ensure that you are familiar with the risk factors associated with the company and also as filed with the SEC. So today, I would like to provide an overview of PDS Biotechnology. I'll discuss also the company's versatile platform technology and some of the science. I'll talk a little bit about our early human clinical trials and how that has informed our process of rapid value creation via our ongoing Phase II proof-of-concept human clinical trials. And at the end, I'll talk a little bit about our strategy regarding potential rapid commercialization of our lead program, PDS0101. So PDS Biotechnology, as you know, is a mid-clinical stage biopharmaceutical company. The company is headquartered in Florham Park, New Jersey, with our lab facilities in Princeton, New Jersey. The company has approximately $34 million in cash as of September and no debt. This is quite important because this allows us to focus on our operations and execution of our human clinical trials towards early data generation and rapid value creation for the company and the company's shareholders. As I mentioned, the company's platform technology is a versatile and potent T-cell activating platform that is being applied towards the development of new treatments for cancer as well as novel T-cell activating or T-cell inducing infectious disease immunotherapies and vaccines, both based on this platform. We have demonstrated promising clinical efficacy in early human clinical trials of PDS0101 that I will talk about today. And this is monotherapy and, very importantly, a favorable safety profile with no dose-limiting toxicities observed even at the highest doses tested. So on this slide, I show our deep and robust pipeline of products, which address over 10 different types of cancer as well as 3 infectious disease indications. One of the things you'll also notice here is the quality of partnerships that the company has already attracted, these being the top institutions when it comes to cancer and immuno-oncology in particular. This is a direct result of the quality of the company's science and data. And we see this also as an early validation of the approach that PDS is taking to the treatment of cancer. So here, you see PDS0101, our lead program, is addressing HPV-associated cancer. So these include head and neck cancer, which many of you may realize is rapidly increasing in incidents due to HPV infection; cervical cancer, which has remained steady over the last several years; anal cancer, which is also on the rise; as well as vaginal, vulvar and penile cancers. We have 3 Phase II clinical trials that are going to be running shortly. One of them has already been initiated. That is the one in collaboration with the National Cancer Institute addressing advanced HPV-associated malignancies. I'll talk more about each of these clinical trials shortly. We expect that before the end of the fourth quarter of this year that each -- all 3 of these Phase II clinical trials will be well underway. PDS0102 addresses prostate and breast cancer. For this product, formulation development is complete. We also announced recently that PDS0103 addressing breast, colorectal, ovarian and lung cancers is being developed in collaboration with the National Cancer Institute. And so with this program, preclinical combination studies will be performed at the National Cancer Institute. And this program then progress into human clinical trials, hopefully sometime in 2021. And we also have our program in melanoma. With infectious diseases, our strategy is to develop these programs in partnership with other institutions. And you see here with our universal influenza vaccine that is currently being funded by NIAID. And also we have the partnership with Farmacore, both in tuberculosis and COVID-19, which I will talk about. Okay. So let's move on to the Versamune platform. So what exactly is this Versamune platform? This is based on novel and proprietary positively charged lipids with the structure shown on the screen. So on one side of the molecule, we have a positively charged group, which is then linked to 2 hydrocarbon chains, insoluble hydrocarbon chains. This structure allows for spontaneous formation of spherical nanoparticles in aqueous environment. So these are nanoparticles coated on the entire surface with a positive charge. What we also do is we size these nanoparticles to mimic a virus. Our immune system is very well adapted to picking up viral particles and viruses, so this enhances and facilitates effective uptake of the nanoparticles by our immune system. Also, very importantly, most cancers contain unique proteins, which are not contained or expressed in our normal healthy cells, and an important fraction of our white blood cells, known as our T-cells, can actually recognize and respond to these unique tumor-specific proteins, which I'll refer to as the antigens. So what we do here is we combine our nanoparticle with the specific tumor antigen specific to the cancer we're seeking to treat. So in the case of PDS0101, this would be the HPV viral protein that is associated with the cancer. So this is combined with the nanoparticle and given as a subcutaneous injection. Now our skin provides the first barrier of defense. And just beneath our skin are a number of immune cells known as dendritic cells. And so as I mentioned, these are sized for effective uptake. These dendritic cells pick these nanoparticles up highly efficiently upon subcutaneous injection. Based upon the composition of the nanoparticles, these dendritic cells get activated. And when they get activated, they migrate into the lymph node. That's the process by which these work. They migrate then into a lymph node and we get highly effective presence within the lymph node. Now here, a major obstacle facing immunotherapy is access to the MHC Class I presentation pathway. This presentation via this pathway is critical to train a fraction of our T-cells known as the killer T-cells, extremely important in their ability to fight cancer. What is typically done is accessing of what's known as the MHC Class II presentation pathway, which leads to activation of what we call CD4 or helper T-cells. One of the significant advantages of the Versamune technology is, again, based upon the lipid composition, the specific lipids we use, it is able to destabilize the cell and allow the cancer tumor antigen to be effectively processed, access the MHC Class I presentation pathway to effectively train and prime killer T-cells to recognize the cancer and recognize the tumors. They're a very important aspect of characteristic of diverse immune nanoparticles. Now it's also important to notice that it's one thing to be able to train and prime T-cells, it's another altogether to have a large number of T-cells to effectively train and activate. One important and unique characteristic of the Versamune technology is, again, the specific lipid we use is able to activate what is known as the Type I interferon signaling pathway. This is an important immunological pathway known to be critical to effective anti-tumor and antiviral immune responses. We demonstrate in the lymph node that these genes are up-regulated, meaning that we induce the right signals, causing a heavy infiltration of T-cells into the lymph node. We see this infiltration occurring for over a week after a single dose of the immunotherapy. So -- and we also see enlargement of the lymph nodes due to this heavy infiltration of T-cells. Now what this allows us to do now is to actually prime and activate a large number of killer T-cells as well as helper T-cells to effectively recognize that unique cancer protein and allow these T-cells to effectively target the tumor cells. So upon training and priming, they then exit the lymph node, seek out and kill the specific cells expressing or containing that unique antigen, which, in this case, are the tumor cells. We see effective infiltration into these tumors and subsequent killing or destruction of these tumor cells. This mechanism was published a little over a year ago in one of the top leading peer-reviewed journals, the Journal of Immunology. And so we've talked quite a bit about T-cells here. It's very important also to note and realize that not all T-cells are created equal. There are some T-cells which are even immunosuppressive. And so within immuno-oncology -- immunotherapy, it's important, first of all, to prime or activate the right phenotype of T-cell, whether it's a killer T-cell or helper T-cell. These T-cells must specifically recognize the tumor. And also, importantly, they must be highly effective and potent in their killing function. What we have done at PDS is to characterize the phenotype and quality of T-cells that aren't induced by the Versamune technology and compare them head-to-head with some of the leading clinical approaches today. And that's what I showed here with the bar graph. So here we see Versamune, and this is specific to PDS. What I'm showing here is specific to PDS0103, which we anticipate will be entering the clinic sometime next year. But we see compared to an adjuvant technology in a 4-combination adjuvant technology that's also being evaluated in human clinical trials. And what we've done here is characterized the darker green bars, which are the polyfunctional T-cells. Now polyfunctional T-cells are T-cells that are known to induce multiple immunological proteins known as cytokines and are the most powerful in their killing activity. And so what we demonstrate over here is that with the Versamune technology, we're able to induce not only a significantly higher quantity of these T-cells but also significantly higher quality of T-cell. So these are specifically CD8 killer T-cells that recognize the tumor. Now it's both -- the takeaway here is tumor-targeting killer T-cells, high quantity and high quality. Well, how does this translate to antitumor benefit? Let's look at the right-hand side, the tumor aggression plot. And this pertains to PDS0101. This is a preclinical study. However, I like to show this preclinical study because it is the most widely utilized HPV cancer tumor model. It allows us to perform apple-to-apple comparisons. All our competitors have utilized this model, and there's quite a bit of data published. So it allows us really to perform comparisons as to how our technology and product is comparing -- is performing compared to the leaders in the field. So here, if you look at the gray line, these are the untreated animals, so we see highly aggressive tumor growth. Now if we present or administer the specific cancer protein, the HPV 16 alone, this is not presented effectively into the MHC Class I presentation pathway to CD8 killer T-cells nor do we -- does it activate the right immunological pathway. So we see very little effect. Now the blue line represents the current state of the art, right? So this is typical of all the public results pertaining to the clinically -- the clinical stage HPV cancer immunotherapies. In this specific study, we utilize GM-CSF. But you can see here that after multiple doses, typically 2 to 5 doses, you will see a slowing down of the tumor growth progression rate, meaning that the animals live or the patients live a little bit longer but it does not actually eliminate the cancer. However, let's take PDS0101, so now we administer the exact same protein in the exact same dose but with the Versamune nanoparticles. Now we get effective presentation into the MHC Class I pathway. We can activate and train a large number of killer T-cells and also activate the right immunological pathways. And so what you see here is that after a single dose, by day 35, there is complete elimination of the tumors. Now this has been replicated in multiple expert labs and done in hundreds of animals, extremely consistent results. Now what is also very important here to note is that not only have we generated a powerful tumor-attacking killer T-cell response, but we've also generated a memory T-cell response, which is extremely important for a robust and long-term antitumor immune response, also very important in infectious diseases to maintain long-term protection against specific viruses. And I'll talk more about that. But what we see over here is that if we take these animals and leave them to go till about 60 days, come back and rechallenge them with the tumor cells, they are still completely protected, confirming that the powerful memory T-cell response has been established. And when that atypical protein resurfaces within the body or within the cells, the T-cells recognize it and eliminate it immediately. So here, critical, we're able to overcome the immunosuppressive mechanisms that are instituted by the tumors, overcome those and induce powerful antitumor responses. So here, what's really unique about this technology is the fact that for the first time, we have demonstrated a simple engineered technology that is able to possess each of the critical characteristics of an effective immunotherapy. First of all, efficient access into the lymph nodes, the ability to prime and activate large numbers of tumor-targeting polyfunctional, meaning the most powerful phenotype of killer T-cell, also activate high levels of polyfunctional helper T-cells, the ability to effectively overcome the tumor's immunosuppressive mechanisms, induce long-term memory T-cells and, very importantly, minimize the risk for toxicity. Now one of the key things that induce toxicity in these immunotherapies is the induction of these cytokines, these immunological proteins within the blood circulation, leading to what we call cytokine stones. In the case of Versamune, these are localized within the lymph node. And so we've demonstrated that we also significantly minimized the potential for any of these systemic toxicities. So very well tolerated in addition to a powerful antitumor response. So let's move on to our lead program, PDS0101. So PDS0101, as I mentioned, is designed to treat HPV-associated cancers. Approximately 43,000 patients are diagnosed each year with these HPV-associated cancers in the U.S. alone. Oropharyngeal cancer, as I mentioned earlier, is -- has been recently described as a silent epidemic due to the significantly increased incidences, especially in men. Cervical cancer is the most common HPV-associated cancer in women. This has remained steady over the last several years. And so what we've shown here in our initial market research is that if we are able to attain even a 20% market penetration, which we anticipate is quite conservative, that the revenues could be anywhere between $700 million and $1 billion a year based upon what the pricing ends up being potentially. Also, one of the key questions I am asked quite often is with the current HPV vaccines, won't the HPV cancer market be eliminated in the next few years? The answer to that question is, unfortunately, no, for a number of reasons. First of all, the current HPV vaccine, such as GARDASIL, are only preventive. They induce and activate antibodies, and they have no ability to clear the infection or the cancer once the patient is infected with the virus. So these vaccines have to be given before the patient is infected with the virus. 0% effective once the patient is infected. What's also very important is the fact that these cancers progress extremely slowly, so they can take decades from the time of infection to late-stage cancer. And so what has been projected by the experts is that many of the patients who we will be treating by the next 10 to 20 years have unfortunately already been infected with the HPV virus. And so this is a market that as we can see with oral cancer, for example, is continuing to grow. We also see the same with anal cancer, the market -- the incidence is continuing to increase. So these cancers will be with us for a while, and we desperately need effective treatments for a lot of these HPV-associated cancers. So here, I'll present some of our initial Phase I human clinical data. This study was performed in patients who were infected with multiple high-risk strains of HPV. They were not restricted to HPV 16, which is the most oncogenic type of the virus. These patients had CIN or pre-cervical cancer, and these patients were all given 3 subcutaneous injections 3 weeks apart. The major focus of the study was safety, to confirm safety of the Versamune technology platform. But what we also did to really understand the translation of the mechanism from animals to humans was to assess the T-cell responses in these patients at day 14. Now so what you see over here is looking at 3 doses: the 1-milligram, 3-milligram and 10-milligram dose. And here, we see evaluation of T-cell responses by 2 methods: interferon gamma and granzyme B. Now this is very important because I mentioned earlier that not all T-cells are created equal. You'll hear a lot about T-cells from many companies performing immunotherapy. However, what's key here is with interferon gamma, almost everyone is measuring interferon gamma-inducing T-cells. These T-cells, however, that induce only interferon gamma are the weakest phenotype of T-cell. Also this interferon gamma induction is not specific to killer T-cells. This is induced by helper T-cells as well as natural killer cells. And so this induction of interferon gamma is not correlated with clinical benefit. What PDS decided to do, however, was, for the first time, evaluate, in addition to interferon gamma, evaluate the induction of granzyme B, which is more specific to the HPV recognizing activated killer CD8 T-cells. And so what we see over here is that we were able to essentially replicate the levels of CD8 killer T-cell induction in humans that were demonstrated in the preclinical models. And you can see here that at the 3-milligram and 10-milligram dose is the vast majority of the T-cells that we induced with the right phenotype of active tumor-recognizing killer T-cells. A retrospective evaluation of the patients also showed very high regression rates in these populations within 1 to 3 months of treatment. So very strong indicators that this is potentially active, just like we saw in the preclinical models in humans. And so the question for PDS was where do we go from here? And how do we rapidly demonstrate proof-of-concept in a much larger patient population? And so what we've decided to do was to go into combination clinical trials as an approach to risk mitigation and rapid proof of concept. So what you'll notice that we have done uniquely with our human clinical trials is that 2 of the 3 Phase II clinical trials are being done in combination with therapies that are already FDA-approved, that have been already demonstrated to be safe, well tolerated and effective. And so we are combining PDS0101 with these FDA-approved therapies in 2 out of the 3 trials. And the question we're seeking to answer with these Phase II trials is, can we improve and enhance the clinical benefit to these patients without compounding toxicity? If the answer to that question is yes, we have a very clear path towards rapid commercialization of the product, and we know exactly what studies to perform to rapidly get these products approved. And so the first trial is a combination of PDS0101 with Merck's KEYTRUDA in the treatment of recurrent and metastatic HPV-positive head and neck cancer. What is also unique about this specific trial is the fact that this is being done in first-line treatment of these patients. KEYTRUDA is the only immunotherapy that has been approved to date for first-line treatment of cancer. And this combination is being studied in that specific patient population. The second is treatment of localized advanced cervical cancer. The standard of care today is chemoradiotherapy. And here we're combining PDS0101 with chemoradiotherapy and treatment of these advanced cervical cancers, stage II through stage IV. The third trial is being done as a triple combination with 2 promising immunotherapeutic agents owned by EMD Serono. And this is being done in all HPV-associated cancers so, so long as the patient has an advanced HPV-associated cancer, anal, cervical, vaginal, vulvar, head and neck cancer, they would be eligible to enroll in this trial. And as I mentioned, this trial is already well underway. So here, the slide summarizes these Phase II clinical trials. So the first one I mentioned is the triple combination in advanced HPV-associated malignancies. All HPV types are eligible to enroll in this trial, 28 patients in this trial. Preclinical confirmation has been demonstrated of the synergy between these 3 agents. And I will show you some of the data on the next slide, and each 1 of them have demonstrated potential efficacy as a monotherapy in early trials. So here, we're taking 3 agents, each of which has demonstrated potential for efficacy as a monotherapy and combining them together. To date, the safety cohort has been successfully recruited as well as the first efficacy cohort. And so we anticipate that we would have the first interim data or the first readouts on efficacy sometime late in the first quarter of next year for this trial. The second trial is a trial that we put on hold in April of this year due to the COVID-19 pandemic. We are reactivating this trial and getting the sites ready to go. This trial is being done, as I mentioned, in recurrent metastatic HPV 16-associated head and neck cancer. 90% of these HPV-associated head and neck cancers are specifically to HPV 16. Here, we combine with Merck's KEYTRUDA and we're looking at a 96-patient trial. I mentioned earlier, this is first-line therapy, which is unique for immuno-oncology combination. KEYTRUDA is already approved as the standard of care for this indication. Our goal is to get this trial underway in the next couple of months, should be well underway before the end of the quarter. The third trial is being done in collaboration with MD Anderson. Again here, we're looking at advanced localized cervical cancer, combination with chemoradiotherapy in 35 subjects. And here, again, we have all approvals from the FDA, the IRB approvals. As you may be aware, Houston was a COVID-19 hotspot, and so there has been a slight delay in activation of this trial but we have been informed that this trial will get underway anytime. We're just waiting to hear from MD Anderson that they have initiated the trial. So again, with this trial, we anticipate that before the end of the fourth quarter, this trial will also be well underway. So 3 trials should be running in the fourth quarter of this year. This slide demonstrates some of the key data that was generated by the National Cancer Institute combining PDS0101 with M7824 and NHS-IL12. The study was published in the Journal for Immunotherapy of Cancer a couple of months ago. What is very interesting here is that you can see that with the combination of the other 2 EMD Serono agents, here, we're looking at tumor staining. So these are actually portions of the tumors. Once combined with PDS0101, what was extremely interesting was the fact that not only did they note a significant increase in the number of tumor-targeting T-cells, both CD8 and CD4, the red dots represent the CD4 helper T-cells and the red dots represent the CD8 killer T-cells. But there was a significant increase improvement in the specificity of those T-cells that have been activated, now very specific for the tumor. And here, you see a very heavy infiltration of these T-cells into the tumors upon addition of PDS0101. Essentially, [ antagonistic ] turning the tumors from a cold tumor to a hot tumor simply by giving a subcutaneous injection, activating the right immunological cascade, leading to a powerful tumor-targeting CD8 T-cell response. And you see here that we -- PDS0101, based upon this immune response, dramatically enhanced the tumor regression, okay? So now let's move on to infectious diseases. Now so to summarize the oncology programs, we will have 3 Phase II clinical trials running PDS0101 before the end of the fourth quarter. We are anticipating that PDS0103 addressing colon, breast, ovarian and lung cancers will be in the clinic sometime in 2021. The mechanism of action very powerfully in inducing these tumor targeting CD8 T-cells and, very importantly, the ability to overcome the tumor's immunosuppressive mechanisms. And so how do we apply this technology to infectious diseases? What we're doing with infectious diseases is key induction of highly potent virus-specific CD8 killer T-cells and CD4 T-cells. This is important. We know based upon the emerging data in COVID-19, we know today that T-cells and CD8 T-cells may actually be much more important than neutralizing antibodies. What we also demonstrate with this technology is rapid induction of high levels of circulating neutralizing antibodies within 14 days of vaccination also, very importantly, simple, safe and effective subunit vaccines. And when I say subunit vaccines, I'm specifically referring to protein-based and peptide-based vaccines, which traditionally have been a lot safer but also a lot less effective. With the Versamune technology, we can really enhance the presentation of these proteins and peptides to the immune system as well as activation of the right immunological pathways. And so what we demonstrate is now we can generate safe and potent subunit vaccines, also suitable for rapid commercial scale-up. You can see that this is a simple technology-based upon the way it's been engineered with these cationic lipids. So here, let's look at some data specific to COVID-19. So here, what we're looking at is the antibody response. We see -- here, we are looking at the antibody response to the receptor-binding domain of the SARS-CoV protein, the spike protein. So this is the surface protein of the virus. And what we see here, we're delivering both the spike and the RBT domain as well as the bigger, what we call the [ S1 ] domain, which also encompasses the RBD domain. And so what you notice here is that after administration of these 2 proteins, different formulations to the animals, we see a very weak antibody response at 14 days. And if you look at the neutralization, these both have less than 20% neutralization, so low antibody response as well as low percentage of neutralizing antibodies. However, when we simply combine either the RBD domain or the spike 1 protein with Versamune and administer, we see an over 100-fold increase in the neutralizing antibodies generated just within 14 days. And again, what you notice is that even with the neutralizing, we have about 95% or more neutralizing antibodies. So a very powerful generation of these COVID-19-specific antibodies with a significant portion of them being effectively neutralizing antibodies. Now what you also notice here and what was very interesting to the investigator, so this study was done at the University of Kentucky School of Medicine. And what you'll notice that this is a recurring theme. What we've done at PDS is had most of our data, both immunology and animal studies, generated independently by experts in the field that gives us, management, confidence that this data is replicable, can be generated by multiple experts and allows us to be highly confident in presenting this to investors. And what you see over here is what really surprised these investigators was that at day 14, the levels you see here was similar to what they were seeing in the COVID-19 patients who were hospitalized in the ICU. Now what was also important here is if you look at the slide here, you see that going from day 14 to day 30, we continue to see an increase, about a tenfold increase, without further vaccination of the antibody levels. Now this is due a result of the mechanism by which Versamune works. If you remember, I said, when it gets into the lymph node for over a week, we see a heavy infiltration of both B-cells, which are antibody-related and T-cells. And so we get a continuous priming of these disease-specific immune responses, leading to these powerful and continuously building immune responses. So very important to note, the level and power of the immune responses that are generated by this technology. Now if we look at the T-cells, we have a very similar effect with T-cells. So here, we're looking at the S1 domain of the SARS-CoV protein as well as the full spike protein. And what you see over here is that with both of these proteins, Versamune is able to deliver them highly effectively into both the Class I and Class II pathways, leading to a generation of powerful CD8 and CD4 T-cell responses, again very specific to the SARS-CoV virus. And so you see here without Versamune, very weak T-cell responses. And then we give the exact same proteins with Versamune and we see a dramatic enhancement of those T-cell responses. Now very important, what we also did was looking at all the immune cells within the body to quantify how much of these are polyfunctional. You see here that we get a large percentage of these CD8 and CD4 T-cells being polyfunctional, again confirming that with these infectious disease antigens, we can perform a very similar presentation to immune system, generation of the neutralizing antibodies as well as powerful tumor-targeting T-cells. We also confirmed that we're inducing memory T-cells with the SARS-CoV, again very important in long-term protection against infection with the disease. We know today that there have been quite a few reports that the neutralizing antibodies are only short-lived. We know that the memory T-cells can last a lot longer, and so the ability to be able to induce both the immediately working neutralizing antibodies and the long-term long-lasting memory T-cells becomes very important in the development of an effective vaccine. One of the key things also is we are generating and developing this vaccine, as what we call, a second-generation vaccine. We are not seeking to be first, second, third, fourth or fifth to market. But what we are demonstrating is based upon the knowledge we have today, this breadth of immune responses is now known to be critical. And so in terms of the characteristics of a successful global vaccine, we believe they are the certain key characteristics that the vaccine must possess. It must demonstrate the right breadth of immune responses, meaning that it must generate neutralizing antibodies. It must also generate CD8, CD4 T-cells as well as memory T-cells. The vaccine should be safe, very important for a successful preventive vaccine. The vaccine should be simple. What you can see here is that this does not contain live viruses, DNA, RNA. This is simply diverse immune lipid-based nanoparticles and the recombinant proteins associated with the virus. And it must also be stable and easy to scale up and manufacture at commercial scale. The Versamune-based vaccines check each of these boxes, very versatile technology, very powerful technology. Okay. Let's move on to the intellectual property and the financials. So PDS Biotechnology has a strong patent position. The Versamune-based patents are owned and we have a couple licensed by PDS Biotechnology. These patents cover both methods and composition of stimulating and promoting an immune response using these positively-charged lipids in various forms and mechanisms. The currently issued patents provide protection through 2034. We've patented the use of these cationic lipids to induce an immune response. The use of any cationic lipid to activate what's known as the MAP kinase pathway, the use of the pure [indiscernible] which is the form of the lipid that we currently use. And what we have done at PDS is to generate multiple layers of protection. So currently, we have 10 patent families, which 5 have been issued, additional 5 still going through prosecution. And these have been issued in multiple countries, including Europe and Japan. So a really strong patent position. In terms of the financials, I mentioned as we started, the company has approximately -- over $30 million in cash and no debt, which really allows us to focus on our operations and guide execute on our clinical trials through initial data generation. We expect that this should give us approximately 2 years of runway. Key milestones that we expect to accomplish with these with the funding that we currently have. I mentioned and we've already initiated the NCI-led Phase II combination study in advanced cancer. We intend to initiate the MD Anderson-led Phase II clinical trial in cervical cancer as well as the trial with Merck's KEYTRUDA in the fourth quarter of this year. We should also -- we do expect to get the interim data from the first trial sometime late in the first quarter of next year. We expect that all the interim data would come out anywhere between 12 to 18 months after start of each of these trials. And the goal here is also to generate initial feasibility data on our universal flu vaccine in the next several months. So the company has a strong and experienced management team. I have been in the industry for several years, have senior executive experience in a number of pharmaceutical companies, most recently at KBI Biopharma, where I was one of the founding executives; extensive drug development experience at the Liposome Company as well as Schering-Plough, which now Merck. Dr. Lauren Wood, our Chief Medical Officer, has over 30 years experience at the National Cancer Institute and was head of the Clinical Trial Division of the cancer vaccine section of the National Cancer Institute, so extensive experience developing the kinds of products that we're currently developing. Greg Conn, again, a wealth of expertise, companies such as Merck and Regeneron, developed drugs through all stages of development through -- from preclinical through commercialization; and Michael King, our Chief Financial Officer, who is currently interim. So to conclude, what I will reiterate is that Versamune is a powerful immunotherapy platform that activates both preventive and therapeutic immunological pathways. We have demonstrated a potential for strong clinical efficacy as well as durability of the immune response with minimal toxicity. The company is developing a diversified pipeline focused on both oncology and infectious disease. And we are performing our human clinical studies in areas of high unmet medical need and, very importantly, supported by leaders in the field. So that is PDS Biotechnology in a nutshell. Thank you very much, and I'll be happy to answer any questions you may have. Thanks a lot.

Thank you, Frank. I'm Ahu Demir, the NOBLE Research analyst who covers PDS Biotechnology. Here are the questions I have selected as well as a couple of my own. The first question, Frank, is, can you elaborate on the differentiating factors of the coronavirus program from the first-generation vaccines?

So from -- with the first-generation vaccines, the vast majority have been focused on the induction of neutralizing antibodies. And a lot of these vaccines are primarily due to neutralizing approaches such as live vectors, DNA, RNA. And, as I mentioned, the focus is really the induction of neutralizing antibodies. How the second-generation vaccines will be differentiated, what we expect is that the second-generation vaccines should induce a broader range of immune responses and, very importantly, induction of T-cells. So not just CD4 T-cells but, very importantly, the CD8 T-cells as well as the memory T-cells. And that's really what we anticipate will be a key differentiator and key improvement over the first-generation vaccines will be the breadth of immune responses that are generated and also, very importantly, the safety of the vaccines.

Thank you, Frank. The second question comes on the coronavirus program as well. What can you tell us about the progress with respect to the PDS0203 and PDS0204? What are the time lines? And when will we hear about it?

So I'll start with PDS0203. PDS0203 has completed preclinical development. We expect that we will present the data for publication sometime in the near future. We have already submitted the initial preclinical data to the FDA and received some initial feedback from the FDA. As I've mentioned previously, with our infectious disease programs, we expect to progress these through nondilutive financing means, so in terms of partnerships with other companies or through funding from governmental or nongovernmental agencies. And so that is the approach we're taking. We're still in discussions with some of these agencies. And so once we understand exactly what the timing is, we'll make that known. But that's currently our approach to utilize the current finances we have, focused on our oncology programs and progress our infectious disease programs through these partnerships and on nondilutive financing. With PDS0204, this is the program that we are developing in partnership with Farmacore, and the program is currently with Farmacore. And so once we progress it, complete their portion of the work, we will then be able to progress the program. But it is currently with Farmacore.

Okay. And the next question is regarding the partnership with Farmacore. So the question is are there a lot of articles going around in Brazil mentioning government funding for Farmacore. Could you comment on this?

No. I cannot really comment too much on that. Farmacore does intend -- so we announced in our press release that Farmacore does intend to obtain government funding to progress this program into human clinical trials. Since we have not been in discussions directly with their government, it's difficult for me to comment on exactly where they stand with those discussions.

Okay. My next question is regarding the value-generating catalysts in the next 12 months, Frank?

So key catalysts in the next 12 months, those will [ primarily ] stocking with the oncology programs. As I mentioned, we will be initiating 2 -- the remaining 2 of the 3 clinical trials, the trials with MD Anderson and the trial with Merck combining with KEYTRUDA. So those, we anticipate, will be initiated in the -- before the end of the quarter. I also mentioned that the safety cohort for the first trial, the NCI trial has been successfully recruited and has progressed to recruitment of the efficacy cohort. We do expect that the data from that efficacy cohort could be available sometime in late first quarter of next year. With each of these trials, we expect the interim data to occur anywhere between 12 to 18 months after start, pending how the recruitment of the patients go. So there could be potentially some additional information from the other 2 trials in the next 12 months. However, I would say very cautiously that, that is going to depend upon the recruitment rates and exactly when those trials get underway. I do expect that with PDS0202 for universal flu, that we will complete the preclinical studies and have an idea of when we would be able to move that program into human clinical trials also. And with PDS0103, we expect to move that also into the clinic in the next 12 months.

Okay. Well, Frank, that's all the time we have today. Thank you for helping us get a better understanding of the company's story. If you would like to get the independent research I have written on PDS, go to channelchek.com and type the company name or the ticker PDSB in the search box located in the top left, company data section of the site. Again, thanks to our guest, Frank Bedu-Addo from PDS Biotechnology.

Thank you very much.

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