This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk01: Greetings and welcome to the VaxArt second quarter 2022 business update and financial results conference call. A question and answer session will follow management's opening remarks. Investors may submit written questions to ir at vaxart.com. As a reminder, this conference is being recorded. I would now turn the webcast over to your host, Brant Behan, Senior Vice President, Business Operations.
spk05: Good afternoon and welcome to today's call. Joining us from VaxArt are Andrei Floriu, our Chief Executive Officer, Dr. Sean Tucker, our Founder and Chief Science Officer, and Dr. James Cummings, our Chief Medical Officer. Before we get started, I would like to remind everyone that during this conference call, VaxArt may make forward-looking statements, including statements about the company's financial results, financial guidance, its future business strategies and operations, and its product development and regulatory progress. including statements about its ongoing or planned clinical trials. Actual results could differ materially from those discussed in these forward-looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process, the extent and duration of the impact of the COVID-19 pandemic, and other risks described in the risk factor section of VaxArt's most recently filed annual report on Form 10-K, and other periodic reports filed with the SEC. VaxArt undertakes no obligation to update any forward-looking statements after this call except as required by law. I'll now turn the call over to Andre Florio. Andre.
spk07: Thank you, Brent, and thank you, everyone, for joining us today. As discussed during our call on June 22nd, Vaxart is committed to providing our investors with more frequent communication, and we are pleased to have this opportunity to review our recent progress and outline our upcoming milestones. This is, in fact, Vaxart's first quarterly call in many, many years, and it couldn't have happened at a better time. Our mission here at Vaxart is to realize the full potential of our oral pill vaccine class. which we believe has the potential to revolutionize vaccines, as well as how we think, how we vaccinate all around the world. Vaxart's vision is that of a world where oral tablet vaccines are a reality, allowing more people to be more easily and painlessly vaccinated faster with just a glass of water. The world where oral tablet vaccines provide superior protection by harnessing the power of mucosal immunity. And while oral tablet vaccines could offer tremendous benefits across the full spectrum of targeted applications, they could have a particularly significant improvement over needle vaccines during pandemics. Indeed, we believe that our oral tablet vaccines could revolutionize how we fight the current COVID-19 pandemic as well as future ones. It is this powerful vision, this immense potential that drives us here at Vaxart. Equally important, the same vision and potential has been generating impressive enthusiasm among our shareholders. And we would like to thank them for making Vaxart special or validating our purpose. We are very excited to be talking to you today. As I mentioned in our June 2022 investor webcast, I believe that VaxArt today is in the best position it has been in its entire 15-year existence, after undergoing a significant transformation over the past two years that allowed us to internalize key capabilities and strengthen our human capital, from the labs to the GMP suites to the management team. What this means is that VaxArt is now in the best position it has ever been to leverage the potential of our oral vaccine platform by progressing multiple programs in parallel. And this is happening at a time when the need for better next-generation vaccines could not be more clear. The COVID-19 pandemic in general, and the Omicron variants in particular, have exposed the multiple significant shortcomings of needle vaccines. And now monkeypox, is reminding us that COVID-19 is unlikely to be the last pandemic we'll see in our lifetime. The potential advantages of oral pill vaccines are significant, particularly in pandemics. More people will get vaccinated by oral pill vaccines, and mass vaccinations with an oral pill could potentially be done much, much faster than by needle. Furthermore, as my colleagues, Drs. Tucker and Cummings, will cover in more detail, the potential advantages of our vaccines go well beyond the oral pill format. By triggering mucosal immunity, our vaccines have the potential to offer broader protection against a wider array of variants and pathogens, to protect for a longer period of time, and to reduce transmission. Now, let me talk to you a little bit about two key clinical programs, COVID-19 and norovirus. One of the challenges of developing COVID-19 vaccine is doing so against a virus that continues to evolve, basically a moving target. We started developing our COVID-19 vaccine in a world that was dealing with just one strain. As more strains started to appear, we grew more confident that our oral tablet vaccine candidate would offer superior protection due to the cross-reactivity of mucosal immunity and the powerful T cell responses. We now believe that the best way to leverage this distinctive cross-reactivity is to aim for solutions with future-proof potential by expanding our portfolio to include constructs that also target the new Omicron variants of concern, BA.4 and 5, and to study those as both monovalent and bivalent constructs. Doing so could have multiple clinical and strategic advantages. It positions us better for our human Omicron challenge study in the UK. I remind you that this is the first such study announced worldwide. It positions us better relative to our needle-based competitors. As everybody started work on BA4-5 variants, only recently. And it fits the recommendations and expectations of regulators such as the FDA, which recently announced that boosters should target the DA45 variant. Therefore, we are very excited about the prospects of our enhanced portfolio and, as my colleagues will cover in more detail, about its future-proof potential. Now, let me turn to our other lead clinical program. During this quarter, we have also continued to make progress with our norovirus program by adding to the clinical evidence that continues to make us ever more excited about the prospects of this program. The recent data from our trial in elderly adults is very encouraging, as it suggests similar activity as in younger adults. This is not often the case with injectable vaccines, therefore providing yet another potential source of differentiation for our oral pill vaccine candidates and increasing our confidence as we continue our development. And now, I'll hand the call over to Dr. Sean Tucker to review the multiple advantages that our oral vaccine technology offers.
spk02: Sean? Thanks, Andre. I'd like to remind the listeners that we have already reported on multiple data sets demonstrating clearly that we can generate a robust mucosal IgA response. And these responses could have the potential to provide superior protection at anatomical sites where infections actually enter the body, such as the respiratory and intestinal systems. This benefit is not really observed with injected vaccines, which make more of a blood-based serum response. Now, there's a growing body of data that supports in our belief that mucosal vaccines can provide a robust protection against a variety of infectious disease, and again, this is data from us as well as others, that potentially reducing the risk of infection and transmission, and therefore addressing critical public health challenges. So, as Andre talked about before, the COVID pandemic has revealed challenges associated with mass vaccination campaigns using injected vaccines And again, some of these require not just cold, but ultra-cold chain management. These challenges have definitely limited the development of potentially life-saving vaccines to low-income countries and rural areas, even within the middle and high-income countries. They also require trained personnel and specialized equipment, which have been in limited supply, especially during the pandemic. Injected dust vaccines also require people to travel to a vaccination site, further increasing increasing barriers to vaccine access. In contrast, our vaccines are room temperature stable and provided in an oral format. This radically simplifies mass vaccination campaigns by enabling potentially self-administration at home without using any special equipment or trained personnel and removing the need to schedule and travel for appointments. One of the other things about our technology is it really eliminates a lot of the medical waste. which has been an environmental and economic challenge throughout the COVID-19 pandemic. Finally, the thing I'd like to mention is vaccines only work when patients actually get the vaccine, and our oral vaccine may overcome some vaccine hesitancy individuals who don't like injections and therefore potentially increasing the number of people that can be protected against infection. Over the past several months, we've reported multiple data sets supporting the broad potential of COVID-19 vaccine candidates to tackle the challenges of evolving virus and the virus that continues to overcome immune protection provided by the currently approved vaccine. Just recently, we published data in a preclinical hamster study done with researchers at Duke University. And again, this was published in Science Translational Medicine. And it demonstrated that our S-only COVID-19 vaccine candidate could reduce disease and airborne transmission We've also shown preclinical data demonstrate that two of our vaccine candidates targeting the SARS-CoV-2 S protein for Wuhan or the S protein for Omicron could protect hamsters when challenged with Omicron VA1 variant. Additionally, we have lots of preclinical data suggesting that the administration of the S only or the S plus N COVID-19 vaccine candidates to the mucosa of non-human primates produced significant increases in serum IgG as well as IgA, and up to a thousand-fold increase in the nasal IgA responses against SARS-CoV-2. Importantly, all vaccinated animals challenged with SARS-CoV-2, this is the beta strain, one of the more recent variants, has a significant reduction in viral titers in the nasal passages compared to unvaccinated controls. And again, this is the case even if the vaccines were developed against other viral strains such as Wuhan. In addition to the growing body of robust data demonstrating the efficacy and safety of our vaccine candidates, we are taking important steps to speed their clinical development. Clearly, we and others believe that mucosal vaccine technology holds great promise, and we are committed to turning that promise into vaccines that can address important public health challenges and create value for our investors. I'll now turn the call over to James Cummings, who will review recent achievements, next steps, and upcoming milestones for our COVID and Norovirus vaccine campus. James?
spk04: Hey, thanks, Sean. I'll begin with our COVID-19 clinical vaccine program. Updated data from the phase one trial of our S plus N candidate showed that this candidate stimulates SARS-CoV-2 specific IGA antibodies in saliva and in nasal samples from the human subjects. And it was cross-reactive to many different coronaviruses that are more divergent even in the circulating variants of SARS-CoV-2 we see now. We believe that this broad cross-reactivity is an important differentiator for Vaxart, given the continuous evolution of novel virus strains that escape immunity from the currently approved needle-based vaccines. Last month, we announced that we have an agreement with H-Vivo Services, a subsidiary of Open Orphan. Under this agreement, H-Vivo will conduct a characterization study and, if successful, develop a human challenge model based on the Omicron variant of SARS-CoV-2 with the intent to conduct a subsequent Phase II human challenge trial for our COVID-19 vaccine pill candidate. In terms of next steps, we have several really important near-term milestones in our COVID-19 vaccine development program. First, we're on track to report preliminary data from the phase two COVID-19 clinical study part one in the third quarter of this year. Second, we intend to make a decision on advancing either RS only or S plus N candidate to a phase two, three trial in H1 of 2023. You know, as a science-based and a data-driven company, we're committed to following the emerging science as novel viral variants continue to evolve. In selecting a candidate to advance to the next clinical stage of development, we'll consider results, once we have them, from the ongoing phase two trial of our S-only candidate and the longevity data from the S plus N candidate. You also, as Andre had mentioned, based on recent FDA guidance, we're evaluating both Wuhan and Omicron-based vaccine candidates to determine really the best approach to providing maximum protection against currently circulating strains, as well as strains that are likely to evolve in the future. Everyone at VaxArts is determined to have a candidate with a high likelihood of success once we enter phase three and the potential to provide benefit to people around the globe and to our investors. We also continue to work with the Indian government to initiate a phase 1B trial in India. As we discussed last month during our call, we've approached the regulatory authorities in India regarding our COVID-19 study as both a boost and those who have been previously immunized, as well as a primary vaccination in a vaccinee naive population if possible. And it's been very well received. That said, the Indian regulatory pathway does take time. Also, as our vaccine and our platform is novel compared to the injected needle-based vaccines that are available, testing of our product by the Indian regulatory authorities does require some enhanced capabilities on their part to evaluate our vaccine candidate, and we've been very responsive to their questions. We're looking forward to embarking on our study in India once regulatory review is completed. We intend to refine that study based on data from Part 1 of our Phase 2 COVID-19 study conducted here in the United States. Now, let me pivot to our recent progress and next steps in our norovirus program, if you will. In June, we reported positive preliminary data from a Phase 1b trial of our norovirus vaccine candidate in subjects aged 55 to 80 years old, which showed stimulation of very robust immune responses across all doses with a dose-dependent production of IgA antibody-secreting cells. Notably, these results were consistent with previous studies conducted in younger populations, and it's important. That's typically not the case, as the immune system generally weakens with age, and older folks tend to have a less robust response to vaccination than younger people. You know, we're very excited about these findings because they demonstrate the power of our vaccine technology, of our platform, and because adults over the age of 65 years are generally more vulnerable to norovirus infection, with 7.5% of this population infected annually. The data generated to date suggests that our norovirus vaccine has the potential to provide protection against norovirus across a wide age group. Building on the promise of data generated to date in our norovirus program, we expect to initiate a phase two trial of a bivalent norovirus vaccine later this year. This vaccine would include two norovirus proteins, G11 and G24. They're the ones that are, the virus strains are generally responsible for most of the norovirus in the world, potentially stimulating even more robust immune responses than we've seen in our monovalent candidates. We expect to report preliminary data from the ongoing phase two norovirus challenge study toward the end of the first quarter of 2023 or the beginning of Q2. Before I turn the call back to Andre, I'd like to say how proud I am of the work that our team has accomplished, especially in light of the challenges that we and many others have faced while operating in an ongoing global pandemic and global supply chain challenges. I'd like to thank everyone at VaxArt, our academic and clinical collaborators, and our volunteers participating in our clinical studies for their contributions to helping us realize our vision of transforming the vaccine landscape. I'd also like to thank our investors. You've put your trust in us, and we will get the job done. Back over to you, Andre. Thank you, James.
spk07: Before we move on to the Q&A session, let me say a few words about our cash position and upcoming milestones. We have a strong financial position with $131 million in cash and cash equivalents as of June 30, 2022. This provides us with runway until the second half of next year, 2023. Now, let me share highlights of important milestones we expect over the next 12 months or so. Topline data from the Phase 2a COVID-19 clinical study is expected in the third quarter of this year, 2022. Selection of the COVID-19 vaccine constructs is expected in Q4 of this year, with clinical trials to start in the first half of next year. Updating the plans for our India trials after determining which COVID-19 vaccine candidate to advance will follow. Then the start of phase two trial of Vaxxer's bivalent norovirus vaccine candidate is expected in Q4 of this year. After that, top line data from our ongoing phase two norovirus challenge study is expected at the end of the first quarter or early in the second quarter of 2023. And finally, the Omicron human challenge trial in the UK is expected to start in the second half of 2023 using the selected COVID-19 vaccine construct. So, many important developments over the next year to year and a half, including important value inflection points. We are thus very excited to continue to work hard towards unlocking the full potential and value of our unique oral pill vaccine platform. I want to thank everyone who has joined us for our call today, and especially to our investors who continue to support our mission. We'll now begin the Q&A portion of the call. Alex.
spk01: Thank you. At this time, we will be conducting a question and answer session. If you'd like to ask a question, 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 the star keys. Our first question comes from the line of Charles Duncan with Cantor Fitzgerald. Please proceed with your question.
spk03: Hi, this is Pete Stavropoulos for Charles. Andre, team, congratulations on all the forward movement. I have a couple of questions. In terms of getting a vaccine approved as a booster for COVID, what do you think the regulatory authorities such as the FDA and EMA would require in the case of a vaccine that is not approved or has generated efficacy data from a larger study as a primary vaccine? Have the agencies provided guidance? And sort of with that, have you spoken to the regulators about data generated from the challenge study supporting a potential filing as a booster, especially if you can make clear correlations between IGA responses and protection?
spk04: Thank you. This is James. So sort of two things on that answer. One, we've been in close contact with both the regulatory authorities, continued dialogue here in the United States with our own US FDA, as well as outside the U.S. with the EMA, HMRA, and other countries across the globe. In terms of a pathway forward, it will depend really on having data in hand, and I think that's why our challenge study really is so important. So taking a look at a challenge study, getting, I think, the key answer in terms of protection against infraction. So you know, having that teamed up with a marker of immunogenicity so we can have a correlative protection is very important. But also taking a look at a decrease in nasal shedding of virus, of shedding of virus to decrease transmission. I think those two or three questions, a decrease in symptomatic disease as well, will really go a long way in helping, I think, structure what a phase three follow-on study would look like but also inform some of those regulators to give us an idea of a clearer pathway forward. It also depends on what the case of the pandemic is at the time. You know, if we know that SARS-CoV-2, the virus that causes COVID-19, has a very sloppy gene editor so that we will see more strain variation. And based on that, you know, if the situation globally is with more disease, more deaths, more issues of quarantine, then I think it ups the ante for getting more solutions, more next generation solutions out there faster and farther. Thank you.
spk03: Good. Thank you for the color. And one question on the Norovirus program. You know, I know that you're planning to initiate a phase two trial of the bivalent vaccine candidate in 4Q. Sort of, can you speculate on the size and duration of the study? And will you be looking at immunogenicity or immunogenicity and efficacy and sort of, you know, how will this study differ from the other studies that the company has conducted on Norovirus? And do you think that this data in combo with the challenge study may enable a registrational study?
spk04: So that's a great question. So in terms of what the, that next study would look like, it will be a phase two, not a phase three. but there will be a look at both immune correlates through this study. We will leverage some of the data we have coming from our challenge study, and we will be looking at preliminary efficacy. We'll be collecting some of that data. I think all of that will help inform, once we get to the end of our challenge study, it will help inform our next step in terms of a larger, more robust study. So looking at dose confirmation with a bivalent approach, looking at results of that challenge study, which, again, will be in late Q1, early Q2 of next year, and taking that amalgam together to the regulatory bodies for further discussion.
spk03: All right. Thank you. And actually, if I could fit in one last question, if you don't mind. When you think about the norovirus vaccine, you know, where do you actually see this fitting in in vaccine schedule, you know, say in the U.S.? ? And who do you see deriving the greatest benefit from a norovirus vaccine?
spk04: So where do we see it fitting in the schedule and who gets the most benefit? Well, norovirus affects everybody, right? But it affects us most dramatically in the early portion of our lives and in the latter portion of our lives. So children up to the age of five are very frequently ill with this disease. And then as we age, after age 55 or 62, we see, again, another spike in terms of symptomatic disease. And the cost, just for those on the line who may not have seen the Johns Hopkins report on this, the cost annually in the United States of norovirus infection, just in the U.S. alone, across the population, is over 10 billion, with a B, billion dollars. So when I look at that, it's the older population and the younger population that are most affected, but then there are other populations, healthcare providers, restaurant workers, people in the hospitality industry, people in the military. These are all folks who could benefit from a norovirus vaccine. So I look at it as a very wide distribution of terms of vaccination strategy.
spk03: All right. Thank you for taking our questions.
spk01: Thank you. Our next question comes from the line of Kumar Raja with Brookline Capital. Please proceed with your question.
spk06: Thanks for taking my questions and also congratulations on all the progress. So with regard to the phase two data, you know, there is some data in literature saying that, you know, previous Omicron infection also provides protection. So what are your thoughts on, you know, the ability of the Wuhan S-only to provide protection against BA4 and 5? Maybe we can just start with that.
spk04: Sean, do you want to start and then I'll finish?
spk02: Yeah, sure. I think that would be the great way to proceed. Yeah, there is some evidence, as you pointed out, that a previous infection with Omicron natural infection provides some protection against subsequent infection. We don't know how long that will last. It may not last forever. People have noticed that the titers wane from natural immunity as well as from the injected vaccine. As We proceed. I think one of the things that we want to know is that, you know, one, can our booster, you know, whether that's with Wuhan for diet protection against other things that pop up, we have seen lots of cross-reactivity, you know, when we look at, especially when we look at by T cells as well as by the nasal mucosa. So we feel like that our approach is more likely to be cross-reactive. I think James could probably address more of the issues when it comes to But from our standpoint, we think that we have, you know, there's good evidence that we can be cross-reactive. There's also the potential that we can improve on that by using an Omicron, you know, BA45, and we're going to evaluate that clinically to figure out what is the best path forward.
spk04: Thanks, Sean. So to that end, what we'll be doing is getting that data, as we mentioned, in this quarter now. in terms of part one or phase two, but then also looking at the impact of other strains. The recommendation from the FDA is to be inclusive of BA.4, BA.5. We'd like to have the Omicron strain. We'd like to have that data and use a data-driven approach as to what we move forward into both the challenge model as well as to larger studies. So more to follow as the data comes in. Thanks.
spk06: And next on to the vaccine supply, how much of the Wuhan-S do you have and how quickly are you able to ramp up manufacture of the new constructs?
spk02: I think, this is Sean, I think from the standpoint of supply, I think we are in great shape to proceed with the next phase two study, if I'm not mistaken. Number two, because we now control our manufacturing internally, we have two different manufacturing, quote unquote, facilities within VaxArt and in Northern California that I believe that we can move very quickly now to make supplies on new constructs. So, James, you want to add to that?
spk04: No, I concur, Sean. I think that we're in the sweet spot now in terms of being able to control our destiny with production. We do have, as you mentioned, not just capacity but product on hand from the previous S-only construct that I look forward to future studies with more to follow.
spk06: Okay. And for the norovirus bivalent also, you have enough drug supply to move forward with the planned phase 2 trial?
spk04: With the way things are planned, yeah. You know, we're currently making those products as we speak, and Again, a bivalent approach, looking at both G11 as well as G24. We put them in people before. It's just that this will be a larger study, a dose confirmation study, looking at that outcome as well.
spk06: Okay, great. Thanks so much.
spk01: Sure.
spk06: Good to see you, Kumar.
spk01: Thank you. I am showing no further questions in the queue. I would like to turn the call back over to Brant Behan.
spk05: Thank you, Alex. So we've got a few written questions that have come in as we've been on the call. One has to do with the India study, and I think, James, you actually covered that in your opening statement, so we'll skip that one. The next one, James, is a clinical question on the norovirus. Maybe it's asking when we can commercialize the norovirus product. I'm guessing it's probably a question about what does a clinical development plan look like. Want to briefly address that?
spk04: Sure. So as I mentioned, right now we're looking at our norovirus program. We're currently undergoing a phase two challenge study, and we should have that data towards the end of Q1, beginning of Q2 of next year. And we're also embarking on a phase two dose confirmation of the bivalent norovirus vaccine program. in candidates moving forward. So I think it takes the data from both of those studies to have a follow-on discussion with the FDA and look at potentially a large phase three. And by large, that's a relative term. You know, I think we could probably move forward with a more reasonable number having correlates of immunity. So a phase three may be efficacy observed. It may also be based on immunogenicity as well. And I think that the data we get from the upcoming studies will help, you know, really shape that process. And then, you know, after the phase three study, I think it's on with good data in hand, God willing, it's on to commercialization. Brent, do you want to comment on that at all?
spk05: I'm sorry, James, I didn't catch that last thing. Who did you ask?
spk04: In terms of commercialization, do you want to talk at all or address that piece?
spk05: I can real briefly, sure. Thank you so much. So I think one of the key things from a commercial perspective was to get the health economics published because that really helps when you're talking to governments, both for the willingness for the government to accept the vaccine and subsequently pay for it. And I think what we showed in the health economics study that was done that this norovirus disease currently every year in the U.S. has probably about 10 times the impact that rotavirus did. And we all know that we have an effective rotavirus vaccine on the market that's well covered and well used in this country. So I think that we're thinking from a commercial perspective that it looks good from that phase. And then back to one of your questions that you had answered earlier in terms of that's the under age five population. For the over 65 population, we believe that This probably would get used like the influenza vaccines currently used in the U.S. So thank you. I'm just looking at some other questions here. So I think one of the couple of questions that actually came in talking about last month's White House COVID summit. James, I'll throw this one over to you first. So what were some of the key results and takeaways following the White House COVID summit in late July?
spk04: Thanks. So there was an overall acknowledgement that we need Gen 2 vaccines to get through this pandemic, especially with regards to virus mutation and variant changes. The first generation of vaccines were a great first step, but it didn't close the door on this virus. You know, there was a recognition of the importance, the value of mucosal immunity, and we see our vaccine as a potential solution to those problems. During the meeting, there was a Dr. Akiko Awosaka said in response to a question from Francis Collins, said, and I'll just quote it real quick, I think mucosal immunity elicited by an oral pill like the Vaxart vaccine is a very promising approach. In fact, we emit a lot of virus from the oral cavity. So if you really want to prevent transmission, you have got to have the defense system in the oral cavity as well as the nasal cavity. So I think it holds a lot of promise. I know the phase one trial is showing promising data for durable responses. I think we need multiple different approaches to be tried because we're not going to bet on just one thing to work for transmission blocking vaccines. The more we can test the better, but I think we need the resources and the help to get there. And again, that's, those aren't my words. Those are Akiko's words at that meeting. So I think that again, there's an understanding of what we're doing is gaining traction. and, you know, looking forward to more results to follow.
spk05: Thank you, James. The next question really is, Sean, I think this is going to come to you, probably a little bit more preclinical. So the question is, how would VaxArts oral tablet vaccine be differentiated from the intranasal vaccine candidates? Sean?
spk02: Yeah, I mean, that's a really good question. One of the things that we believe is that, you know, certainly in preclinical, we know that both intranasal and oral can work pretty well in terms of making the responses. We think, I mean, that oral tablets are just much easier to administer to humans. And on top of it, there's just been some real challenges when it comes to developing intranasal vaccines. For example, the only intranasal vaccine approved is Flumis. We know that works much better in the younger kids that don't have a lot of immunity to flu because the flu seems to block that use. The other thing is that there's been some intranasal vaccines that have caused some rather severe effects. For example, the Berno Biotech nasal flu vaccine ended up causing Bell's palsy and it was pulled off the market. And again, because of the proximity of the brain, you know, when you deliver something intranasally, there is potential issues. Those could be overcome, but we still think from the standpoint of going forward, an oral vaccine is just simpler to the end user and potentially could provide the same sort of immunity that you get from intranasal delivery.
spk05: Excellent. Thank you. Another question here in terms of this is probably going to be broader in terms of questions or answers from all three of you potentially because it's a broad question. What's the latest on the human papillomavirus vaccine and what does the market opportunity look like? James, I think we should start with you on that one and then pass it on.
spk04: Sure. You know, we get asked a lot about the potential for a prevention vaccine, you know, or a therapeutic vaccine. There's a prevention vaccine on the market in the United States, right? for kids over the age of 12 or 15, and it's available globally. Unfortunately, you know, the sad part of this story is that in the U.S., less than 60% of boys and girls are fully vaccinated, and certainly it's less in most countries around the world. The onset of cancer from HPV is, you know, generally we see it age 50 to 65, depending on the actual cancer type. So unfortunately in the U.S., there's still 30, thousand plus cancers from HPV every year. That's a lot of disease that will continue into the foreseeable future, especially if we can't bump up our prevention vaccine strategy here in the U.S. These cancers are expensive to follow. They're tough to treat, and we believe many people would rather take an oral tablet vaccine versus some of the current therapies for the cancer or precancerous lesions that we see today. Andre?
spk07: Yeah, thank you, James. So as James said, unfortunately, there is still a sizable market for an HPV vaccine, both here in the US and ex-US. But what's interesting about our HPV program, strategically, it would be our first therapeutic vaccine, and it could also potentially open up cancer for us. So it would be a very interesting expansion of the applicability of our platform. And as many of you know, in cancer, the role of T cells is very important. So this could play to another dimension of our platform, particularly highlighted by our phase one COVID-19 data results. Maybe Sean, you want to comment or expand on that a little bit?
spk02: Sure. Yeah, several years ago, we made a HPV vaccine, 16 and 18 vaccines and tested preclinically. We knew they could essentially prevent tumor growth or reduce tumors in mice. We thought that was a very nice result. We know that, you know, they were able of making very strong T cell responses, those vaccine candidates. And, you know, several years ago, there was a paper published by Connie Trimble, you know, and I think this is when she was at Cornell, and it suggested that, you know, making a CD8 T cell response, a cytotoxic T cell response, with mucosal homing markers was absolutely the most important thing from the standpoint of clearing lesions and cervical dysplasia. And so we know that our platform, and certainly on the COVID front, we were able to show that we made these type of responses. So we're really bullish that, you know, if you use our platform to make responses against HPV, we could have a very good therapeutic vaccine for this indication. So, yeah, we're very excited about it.
spk05: Excellent. Thank you all so much. Our last question really comes to partnerships, and we've gotten a couple of the questions that are sort of similarly asked, but I'll try and amalgamate them. Andre, I think this is going to come to you. What is your approach to potential partnerships for either the COVID-19 or norovirus programs, and would a partnership feed the program along? So, Andre. And Brad, the last part of the question, please. And would that partnership speed the program along? Would it accelerate the program? Okay, I understand.
spk07: So, look, we are always open to discussions about partnerships because what we want is to really look at all the ways in which we can maximize shareholder value and accelerate the realization of the potential of our platform. And so we have multiple programs. We have been engaged in discussions and open to discussion with various parties. And we continue to be open to exploring those, both here in the U.S. and abroad, both for COVID-19 and not over. That being said, VaxArt is now in a position to optimize really the moment in which we want to enter a partnership and the type of partnership that we will be potentially entering. So we don't want to provide too much detail right now. We will when it's warranted, but partnerships are always an important and interesting tool for development stage biotechnology companies like ourselves. And so, again, we are open to that potential. Now, with regards to speeding up the program, well, that really depends. That depends on the type of partnership, depends on the program. Obviously, you know, one enters the partnership because there is a win-win there and the value of the asset increases. So speeding up the program is one of the potential benefits of a partnership.
spk05: Fantastic. Thank you, Andre. Well, this concludes the Q&A portion of the call. Thank you for participating today. Thank you.
spk01: Thank you. This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.
Disclaimer