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 third quarter 2022 business update and financial results conference call. A question and answer session will follow management's opening remarks. Individual investors may submit written questions to IR at VaxArt.com. As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Brant Bean, Senior Vice President of Business Operations.
spk04: Good afternoon and welcome to today's call. Joining us from FACTSART are Andre Florio, Chief Executive Officer, Dr. Sean Tucker, Founder and Chief Scientific Officer, and Dr. James Cummings, Chief Medical Officer. Before we get started, I would like to remind everyone that during this conference call, Baxart 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 trial. Actual results could materially differ 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. I'll now turn the call over to Andre Florio. Andre?
spk09: Thank you, Ed, and thank you to everyone for joining us today. We are pleased to have this opportunity to review with you our third quarter progress and showcase the transformational potential of our oral vaccine platform. I'd like to start with a financial update that I believe is of interest to our investors. In August of this year, our shareholders approved our proxy proposal that authorized an increase in our authorized shares by 100 million to 250 million shares. During the proxy voting process, many of our individual shareholders were concerned that passing this proposal would lead to an immediate and significant dilution. I'd like to put that concern to rest. In the third quarter, after passing this proposal, we issued only 1.8 million shares, proving that, as we promised, we will continue to be very prudent and opportunistic in issuing new shares. So, I'd like to again thank our shareholders for their support and tell them that their trust had not been misplaced. Let me tell you why we are very excited about the work we are doing at Vaxart and about the significant potential that Vaxart has both to make a big impact on how we fight infectious disease globally and to create significant shareholder value. Since the beginning of the pandemic, Vaxart has drawn a lot of attention to its COVID-19 program and for good reason. And while the potential of our COVID-19 program remains significant, even as the general interest in COVID-19 ebbs and flows, I would like to talk to you about the bigger story here. As a true platform company, VaxStar is much more than just its COVID-19 program. And there are two major parts to this bigger story. One is our other leading clinical program, Norovirus, which we believe represents a huge opportunity for VaxStar. The other is is the broader promise that VaxArts platform holds in transforming the vaccination paradigm globally. While my colleagues will tell you more about the Norovirus opportunity, let me illustrate this broader promise of our technology. Recently, I was invited officially to attend the upcoming G20 summit, more specifically the B20 portion of the G20. So this week I'll go to Indonesia to discuss with world political and business leaders the role that Vaxar's platform could have in global pandemic preparedness in shaping the future architecture of healthcare. Now, small biotech companies do not usually get invited to the G20. However, Vaxar did because of the transformational potential of its technology that addresses one of the summit's main areas of focus this year, how tomorrow's global healthcare architecture could help the world recover together, recover stronger, which is one of the motives of this year's G20. And the Indonesian government is just one of the governments that are interested in exploring the role our platform could have in improving pandemic preparedness for this pandemic and future one. Now, while I've shared these developments because I think they can help you paint a fuller picture of what is going on at Vaxart, and because the very real interest in the transformational nature of our platform and our programs. Our lawyers insist that I state the obvious. While we are hopeful that this interest will translate into tangible support for Vaxart, there is, of course, no guarantee that this will be the case. So, is all this interest justified? Well, we certainly believe so. and I would like to review with you the promise of Vaxart's platform, as told by the data that we have generated so far. First, using Vaxart's platform, we produced the only oral vaccine shown to be as protective as a living injectable in humans against the respiratory pandemic virus. This is a remarkable result. A pill that can be taken with a glass of water, protected as well as a commercial vaccine that needs to be administered by injection. And what makes this result even more interesting is that it showed that the oral pill protected by working very differently than the injectable. Vaxart vaccine produced 6 to 10 times less serum antibodies than the injectable. Yet it protected as well, presumably because it also activated mucosal immunity. Let me say this again. Vassar vaccine produced up to 10 times less serum antibodies than the injectables, yet it protected as well. This point is worth noting because in a needle-centric world, there is a tendency to assess our data using the same lens as that used for injectables, namely looking only at serum data. Yet, forgetting that other arms of the immune system, such as mucosal immunity, are also important contributors to protection. Second, the data we have produced so far across our multiple programs suggests that our vaccine candidates also trigger mucosal immunity and that our vaccine platform has the potential to offer advantages over injectable vaccine in four areas, broad cross-reactivity against variants, reduction in viral transmission, longer protection, and a more benign total obesity. Improvements on even one of these dimensions would be significant. Yes, our data to date suggests our vaccine candidates may well have the potential to improve on all four. Dr. Tucker will review this data in more detail, and you can now also find more on this in our new investor deck, which is available on our website. So for now, I would just like to quickly provide some highlights. What we think is very encouraging is that each of the four potential improvements is supported not by just one, but by multiple data sets from across our programs and trials. For instance, cross-reactivity against variants and other coronaviruses was shown in both our COVID-19 clinical trials, so in two of them. Reduction in transmission or in viral shedding was observed in flu and COVID-19 studies. Durable protection or immune responses were seen in flu, norovirus, and COVID-19 trials. And to date, the benign tolerability of the vaccine candidates we have produced using our platforms is supported by 15 clinical trials with more than 500 subjects. Therefore, we believe that the full promise of our platform should be assessed by looking at the totality of the data we produce across our many programs, rather than by focusing on any individual program. And, as I said, our platform's promise is much more than the potential of any single program, no matter how promising that program is. In conclusion, let me synthesize why we are so excited about where VaxArt is today. A truly transformational potential supported by growing data across programs, costable financial resources, a very strong team, and significant clinical readouts in 2023. These readouts include two human challenge studies in 2023, one for norovirus and the other for COVID-19. These catalysts are significant because challenge studies have efficacy endpoints, namely assessing whether vaccines can protect against infection rather than just looking at immune responses. And now I'll turn the call over to Dr. Sean Tucker to review our recent data in more detail. Then James Cummings, Dr. James Cummings, will discuss our clinical trial program.
spk02: Sean? Thanks, Andre. As you mentioned, we have several key differentiators of our vast platform. So, let me try to provide some color around the data. First, our platform has shown the potential to provide potentially a broader immunogenicity than the injected alternative. For example, in the phase one study of our S plus N COVID-19 vaccine construct, 46% of the subjects had a 1.5 old increase or better. against SARS-CoV-2 in the nasal IgA responses. And all of these responses were highly cross-reactive against all the coronavirus we tested against. Not just SARS-CoV-2, but some really divergent coronaviruses, the beta and the alpha families. Further, we observed that many of these study subjects had responses that were elevated for up to a year. We have also shown substantial cross-reactive T cell responses against SARS-CoV-2. In particular, we showed substantial CD8 T cells, which are much harder to induce by adjuvants alone. So this is a very important point on the T cell side of things. Let me tell you a little bit about our COVID-19 phase two study. This is the S protein only study. And it emphasizes the point again about cross-reactivity. Mucosal responses in vaccinated individuals were cross-reactive to other SARS-CoV-2s and the variants. For example, 50% of the subjects had a mucosal response to Wuhan. And, in fact, 55% of the subjects had a mucosal response to the more, you know, what I would say present circulating strain of Omicron BA.45. So, effectively, everyone that we induced in a mucosal response against Wuhan also responded to the more, you know, personal, or the strains that are going on now. Second, let me tell you a key advantage, another key advantage of our platform. We believe that we'll get longer duration immunity, and we believe it'll be longer the injected vaccine. As you may have read, there have been reported issues with the durability of some of these injected vaccines, particularly with the COVID-19 mRNA vaccine and the injected influenza vaccine. So here's some of the highlights of our data. In our first phase one norovirus trial, we saw a rise in fecal IgA responses that were durable for greater than six months. In our flu challenge study, this is one that's sponsored by BARDA, our oral vaccine had 39% protective efficacy against illness and 47 protective efficacy against infection. Note that we tested this by looking at infection 90 to 120 days after vaccination, not the typical 30 days that's what challenge studies usually look at. We looked at this a much longer time point. Also, as I mentioned earlier, that COVID-19 phase one study, S plus N, we showed nasal IgA responses that remained elevated for over a year. Lastly, in our norovirus elderly study, this is data that we released this summer showing IgA and IgG responses. These were still elevated even after 200 days. Third point that differentiates our oral vaccine or pill vaccine platform is the potential induced or reduced transmission. The proposed mechanism of inducing a mucosal IgA response, this hinders the virus spread to other individuals. If there's a substantial mucosal IgA response in the nose, this IgA can inhibit shedding of a respiratory pathogen, potentially blocking the productive release of virus. Here's some of the highlights of our data. In our phase two challenge study and the analysis conducted by BARDA, there was an 80% chance that our oral vaccine significantly reduced viral influenza shedding better than an injected commercial influenza vaccine, and this was in a head-to-head comparison. In the COVID-19 study, in a hamster study led by Duke University, our vaccine candidate delivered orally or intranasally limited airborne transmission of SARS-CoV-2 to unvaccinated animals, animals that never seen vaccine. And let me highlight this point again. The opportunity to reduce transmission will be a major advantage in the fight against COVID-19 because if you can reduce the speed of the virus propagates in the population, fewer people will get infected at once, and this will not stress out hospital care and other critical resources devoted to care of the sick people. And if you can reduce transmission enough below an R0 of 2, the virus will essentially burn out. In study after study, VaxArt has built a compelling case for our oral pill vaccine technology and for the vast potential benefit it can deliver to society and to shareholders. We have the advantage of being further ahead than many of our U.S. competitors in the mucosal space, and we are committed to completing our mission to bring pill vaccines to the world. Furthermore, By bypassing the need for an expensive cold chain storage, hundreds of millions of people in developing countries who cannot readily access an injectable could finally have access to life-saving vaccines. In all countries where our vaccines receive approval, the environmental impact and cost savings would be significant. And then there is that last bottle of vaccination in developed countries. Clearly, our 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 over the call to James Cummings, Dr. James Cummings, who will review recent achievements, next steps, and upcoming milestones for our COVID-19 and norovirus vaccine programs. James?
spk06: Hey, thanks, Sean. I'll begin with our COVID-19 clinical vaccine program. In early September, we reported top line data from part one of our phase two clinical study, evaluating our S-only COVID-19 vaccine candidate, the 201 study. The vaccine candidate evaluated in the 201 study was developed based on the viral spike protein of the original Wuhan strain of SARS-CoV-2. The data from this study clearly show that this candidate was safe and well tolerated. These safety findings are consistent with the results from over 500 subjects who participated in clinical studies of our tablet vaccine platform. Notably, few or no subjects in this 201 study reported any symptoms to the severity that were commonly reported in the clinical studies of the needle-injected vaccines. The secondary endpoint of the 201 study was the immunogenicity of the S-only vaccine construct. Multiple assessments demonstrate that this candidate induces potent antibody and T-cell responses and stimulates both serum and mucosal immunity. In terms of next steps, we have several important near-term milestones in our COVID-19 vaccine development program. The most efficient pathway to meaningful data for our COVID vaccine program is the Omicron COVID Challenge currently being developed by HIVO in the United Kingdom. Once their challenge model has been validated, we'll move forward with testing our most promising construct as a booster for those previously immunized with the needle-based vaccine. We look forward to having data on vaccine protective efficacy impact on viral shedding, and correlates of immunity that will help shape the studies following after that challenge. I can tell you we are committed to developing the candidate with the greatest likelihood of success in a phase three study. Regarding the study in India, you know, that study was designed well over a year ago, and much has changed in our understanding of COVID and the landscape of potential solutions. While we continue to work with the Indian government and dialogue with potential partners for the best next steps for our product in India, we look forward to the COVID challenge with HVIVO in the UK to further refine our COVID program pathway. In June, we reported positive preliminary data from a Phase 1b trial of our norovirus vaccine candidate. in subjects aged 55 to 80 years, which showed stimulation of robust immune responses across all doses with a dose-dependent production of IgA antibody-secreting cells. We're really excited about these findings because they demonstrate the power of our vaccine technology approach and because adults over the age of 65 years are especially vulnerable to norovirus infection with with 7.5% of this population infected every year. The data generated so far suggests that our norovirus vaccine has the potential to provide protection against norovirus across a very wide age range. Building on the data generated to date, we expect to initiate a phase two trial of a bivalent norovirus vaccine. This vaccine includes two norovirus proteins, potentially stimulating even more robust immune responses than we've seen with our monovalent candidate. We have a pre-specified futility analysis of our study reporting shortly. And if that is positive, we expect to report preliminary data from our ongoing phase two norovirus challenge study in late first quarter or early second quarter of 2023. We're really very excited about the prospects and the upcoming milestones of our clinical trials and continue to demonstrate the transformative potential of our oral vaccine platform. And now I'll turn the call back to Andre for some closing remarks. Andre?
spk09: Thank you, James, and also thank you, Sean, for reviewing our clinical data and our progress and outlining some of the key milestones ahead for us. And now before we move to the Q&A session, let me say a few words about our cash position and upcoming milestones. As we announced in our press release, as of September 30, 2022, we had cash and cash equivalent of $114.8 million. In closing, I am pleased that we are on track to report key updates on our promising pipeline programs through the remainder of this year and during 2023. Our team is motivated, passionate, and excited, and I share their excitement as we build on our momentum and advance our oral pill vaccine platform. Looking ahead, we are focused on enabling a wholly new approach to vaccination that truly has the potential to be the solution to the challenges of longstanding and emerging infectious diseases and to overcome historic inequities in vaccine access. Thanks to everyone who has joined us for today's call and especially to our investors who continue to support our mission. We will now begin the Q&A portion of our call. Operator?
spk01: Thank you. The floor is now open for questions. If you have a question, please press R1 on your telephone keypad at this time. Please hold while we poll for questions. Our first question comes from Charles Duncan with Kansler. Fitzgerald, please state your question.
spk03: Hi, this is Pete for Charles. I would like to say congratulations on all the progress made this past quarter. So, I have a question on the Norovirus program. I know that you're planning to initiate the Phase 2 with the bivalent vaccine candidate in 4Q or 1Q23. You know, sort of, can you speculate on the size and duration of the study? And, you know, will you be looking at immunogenicity? and efficacy or one or the other, and how will this differ from the other studies that you conducted in neurovirus?
spk09: Sean, you want to take this? Pete, thank you for the question. Sean, you want to take this?
spk02: Yeah, again, Pete, thanks for the question. So, the study is immunogenicity study. It's approximately 600 subjects. I believe the plan, it will be rolling two to one, two different dose levels in placebo. Again, as I mentioned before, it'll be immunogenicity. I expect the readout would be sometime, you know, in the middle of next year. I don't think there's efficacy endpoints described, but again, we hope that this study will basically serve the basis for going forward to the FDA with an end of phase two meeting.
spk03: All right, thanks. And in terms of the challenge, the norovirus challenge study, can you sort of make a comment, you know, of sort of how enrollment is proceeding? And are you on track to doing that data in 1Q23?
spk02: Yeah, it's enrolling at a reasonable rate. Our expectation is that we will see data, you know, Q1, you know, of next year.
spk09: All right, great. Yeah, so we said we are still on track with previous guidance, which is to report data end of Q1, early Q2 of next year.
spk03: Okay. And actually back to the phase two we were just discussing a minute ago, what are the gating factors, and have you actually manufactured the required materials for the study?
spk09: I don't know that there are any gating factors. Again, we announced that we are on track with plans to start that end of Q4, early Q1 of this year.
spk03: Okay, thanks. And one question on the COVID program. You know, there's data out there, you know, and also authorizations for Omicron-specific boosters. You know, although really different vaccine platforms, you know, how does this sort of impact your thoughts on your program and sort of which candidates you're going to bring forward?
spk02: Yeah, I mean, obviously, there's definitely some people that are gone with Omicron specific. I think the data out there is a little mixed in terms of whether that's important. Again, what we said we were going to do is we were going to take a look at our data from our phase one, S and N, phase two, S only, as well as looking at some of these new constructs and making some decisions about how to go forward, you know, for the next steps. One of the things I did want to point out is that we did see some strong cross-reactive responses against Omicron in that phase two study, both in sera and mucosa. And certainly that is weighing on us a little bit, you know, from the standpoint of making decision of how to, you know, next steps in looking at efficacy in that Omicron challenge. Obviously, that would be a great first step or next step for the program is to test our vaccines, you know, and show efficacy. not only that they could be protected in a challenge model, but what the correlates of protection could are from the mucosal vaccine.
spk03: All right.
spk09: Thank you. Sorry. If I can add something here. So I think we all know that the shortcomings of the injectable vaccines is that they are backwards looking, if you want. So they are designed for a a variant of the past, right? And I think that's one of the reasons why you see uptake in vaccination with the new Omicron or bivalent vaccines being so low because, you know, I speculate here, but we're really not sure how these are going to protect against emerging variants. And because of immunity, we have the opportunity here to demonstrate cross-reactivity and to potentially demonstrate the fact that you don't need to change vaccines as the variants change and therefore you get off this hamster wheel where you keep running after a pandemic that evolves faster than we can vaccinate.
spk03: Thank you for the added color and definitely looking forward to some data from the human challenge studies.
spk01: Our next question comes from Mayank Manpani with B Reilly Securities. Please face your question.
spk05: Hi, good afternoon, team. This is Sahil Kazmian from Mayank asking a few questions here. I really appreciate the comprehensive update. Maybe piggybacking off the most recent question, now that we're seeing BA.5 representing, you know, less than 40% of cases or so and BQ.1 getting more prevalent, I'm just curious how far along you and your partners are with identifying virus dose use for the challenge study?
spk09: I don't think – okay, Sean, you take it.
spk02: Yeah, I don't – yeah, right now what we're doing is we're certainly looking at a BA.5, you know, from the standpoint of Omicron challenge. We think that's more informative in terms of, like, really testing the vaccine. You're right, BQ is now coming up, and it could be very important. And, again, what we will do is we will start to monitor our candidates, you know, and how their immune responses differ from BQ. you know, from that, from those variants as well. One thing to note, and, you know, and Andre brought this up earlier is that, you know, we have noticed that our vaccine seems to do actually quite well against the Omicron BA.45, and I expect that will happen. It'll look okay as well against the BQ as well.
spk05: Excellent. Thank you. And then as it pertains to the Neurovirus Program and the challenge study that we're going to expect to see early next year, Can you give us some color on what the threshold for a highly attractive profile might look like? Maybe putting in context about we've seen some of your peers do in the field.
spk02: Sure, I'll take this question. One of the things that, of course, is that, you know, when we're using the challenge studies, you're using, you know, really, really high doses of virus. And so the expectation is that it will the challenge results will be something, you know, in terms of a percent efficacy will be on what I would call low end. It would be something on the order of 40 to 50%. Having said that, you know, we have no idea. It could be higher as well. But, and again, you know, there's the one challenge study that's been published that was successful from Ligacyte, you know, and the G11. That was done several years ago, and I believe the efficacy on that vaccine was about 40-some-odd percent. So, again, challenge models are great from the standpoint of understanding can your vaccine be protective and what are the correlates, but you are using quite a large dose as part of that process. Great, thank you. I really appreciate the question.
spk05: Yes, yes, that's great. Thank you very much. And congratulations on all the progress. Appreciate you taking our questions. And best of luck, Andre, at the G20.
spk09: Thank you so much.
spk01: Our next question comes from Dehindu Finroy with Brookline Capital. Please take your question.
spk08: Hi, thank you for taking my question. So, as you may know, Arcturus Holdings recently announced a collaboration with CSL Securus, a global vaccine company, to develop and commercialize self-amplifying mRNA vaccines. So, in that regard, I was just wondering, do you think it highlights interest in emerging vaccine technologies among global companies? I mean, what are your thoughts on it?
spk09: Dr. Yes, thank you. Thank you for the question. So, this is Andre. I think it definitely does. And if you saw that agreement, it was about COVID as well as influenza and what I would call pandemic preparedness oriented. And I think pandemic preparedness is a theme that we see emerge quite a lot recently, at least in our conversations with various government and governmental bodies. So I think the You know, the interest from investors in COVID specifically may weather flow, but if you talk to healthcare bodies and governments, I think there is an increased awareness that we need to be better prepared against potentially future waves of COVID, but specifically or more importantly against future pandemics. And there is a growing realization that fighting these pandemics with just the current generation injectable vaccine is not the best way to go, and therefore we need newer technologies. So I don't know if this answers your question. Yeah, it does. Thank you very much. Well, I would add that we hope and there are signs to see that this will also translate into increased interest from, you know, large biopharma in the sector. Thank you, Andre.
spk01: At this time, there are no more questions in the queue. I will now turn the call to Brant Bean, Senior Vice President of Business Operations, to moderate the investor questions portion of the call.
spk07: Thank you very much. Now we'll turn to questions from individual investors. And while we have a number of these questions, some I think have been covered in the analyst questions that came in. I don't know if we want to push out or expand, Andre. This first one was, what's your approach to potential partnerships for either COVID-19 or norovirus programs? I think you covered a little bit of that, but do you want to expand on that answer that you just gave?
spk09: Well, maybe just a little bit. I mean, I'm going to state the obvious, which is that what we have said in the past, that we are always interested in looking for the best ways to further the progress of our platform and multiple programs and to maximize shareholder value. So we continue to be open to exploring partnerships, whether here in the U.S. or abroad.
spk07: Thank you. Sean, this next one is going to be for you. And the question is, where do you see VaxArts COVID-19 candidates fitting into the next-gen vaccine landscape? Sean, please.
spk02: Sure. Well, we certainly see our pill-based vaccine as a standalone vaccine for those who haven't been immunized, whether because of needle fear or because of large logistics requirements, such as cold chain medical supply personnel. Obviously, you know, in the U.S. and other countries, you know, a lot of people have already been vaccinated or infected, so it's really going to be a booster in a lot of You know, we see it's complementary to other vaccines now. We certainly have tested ours as a booster, you know, with the mRNAs, and we know we can make mucosal immune responses. And, of course, we think that, you know, it might be better from the standpoint of creating a mucosal variant protection and potentially reduce transmission.
spk07: Excellent. Thank you, Sean. And this actually next one will be for you as well. What other infectious diseases would be good candidates for the VaST platform in the future in the second part of this, and are you looking at any specific target indications? Sean?
spk02: Sure, thanks. Well, obviously, I think, you know, we have, you know, in the past been looking at targets that are essentially viral-based, but certainly I think that any vaccine that could benefit from mucosal response could be a really good indication to go after. Our current vaccine pipeline obviously includes COVID-19, respiratory pathogen norovirus, enteric, influenza, respiratory, RSV, which would be respiratory, as well as HPV, which would be something that we start with something that's cervical dysplasia. So, again, there's lots of different targets we could go for and, you know, because the platform is very easy to use. I'm not going to discuss a lot of new ones today.
spk07: Great. Thanks, Sean. Andre, I think you covered this next one a little bit during your opening remarks, but the question is, what's your current cash runway? If you could expand on that a little bit.
spk09: Sure, sure, Brian. So we said that we ended the third quarter with $114.8 million, which means that we have sufficient financial resources on hand to continue to execute our plans into the second half of 2023. And that includes aggressively progressing our two lead clinical programs, which is norovirus and COVID-19. But I want to put this in more perspective, so I'll make two additional points. First, we believe that we have compelling catalysts in the near to medium term. that may create new or more compelling funding opportunities for us. And the second is that there are levers that we could pull to extend this runway significantly if we ever think that would be appropriate.
spk07: Excellent. And so I guess you kind of hit on the next question a little bit. What are the plans for funding the company? So maybe just expand that last bullet a little bit, I guess.
spk09: Well, so we continue to pursue various funding sources available to us. I mentioned in my opening remarks that we continue to be engaged with governments around the world. We think that our platform presents very compelling potential advantages to current technologies. We remain hopeful that these conversations may at some point result in funding, but, again, there is no guarantee, of course. We're also pursuing strategic partnership discussions and, you know, as we've done in the past, opportunistically accessing capital markets.
spk07: Great. Thanks so much. So there's a lot of questions coming in for COVID-19. I'll try and bundle some of them together so that we're not repeating too much here. Sean, the first one I'm going to put over to you, and it says, please provide updated timing for the COVID-19 vaccine construct. What's the decision date? And provide any rationale for any changes from previous expectations.
spk02: Well, let's see. The COVID vaccine construct, well, based on our data from the Phase 1 S and N, the Phase 2 S only, and the newer constructs we're working on for research, we plan to move forward to select our construct for our planned H2O COVID challenge in the second half of 2023. Obviously, the strong cross-reactive response against Omicron we saw from our Phase 2 trial and the Wuhan coronavirus. And this is what the Wuhan trial, it's just a strong candidate for the challenge study. And, of course, we think this could allow us to speed up our development pathway.
spk07: Excellent. Thank you. And sort of a follow-on question, really, this is the same question about, Andre, we'll get this one over to you. What's the timing for the challenge study commencement? I think you hit on that already, and Dr. Cummings also hit on it. But if you could just reiterate what our timing is for the challenge study for COVID-19. Are we on track for second half of 2023? Sure.
spk09: Thank you, Brent. So we had said that we're going to initiate this trial in the second half of 2023. We are on track for that, and we are also looking at ways that would make it possible for us to start that trial sooner. And so once we identify those paths will, you know, obviously make an announcement.
spk07: Great. Okay, Sean, this next one's for you. It has to do with the Phase 2A trial for COVID. The question is, will you be releasing additional insights from the Phase 2A trial beyond the top-line data that you announced in September? If so, when, Sean?
spk02: Yeah, I expect that we will have new insights to present at the World Vaccine Congress in San Diego coming up at the end of the month. and obviously we're continuing to analyze the data, you know, that we've gained, you know, and, you know, new things coming up and when there's something interesting to release, we will release it when it's available. Thank you.
spk07: Andre, this next one's going to come to you and it's back to the COVID challenge study again. So if COVID challenge study results are positive, do you see an accelerated path for vaccine approval?
spk09: Well, so, um, a bit of a challenging question because it really depends on our results from that challenge study. And it also depends on the state of the pandemic at that time. So we are in touch with several regulatory authorities, both here in the States with the FDA and outside of the US to look at global application of our platform against COVID-19. So as we've seen during this pandemic, these regulatory authorities often make different decisions, which are based not only on the strength of the data, but also on how acute their unmet needs. So it's really a challenging question to answer now, but we remain very confident that the benefits of needle-free pill-based vaccine that can provide many of the advantages that we talked about, you know, durable protection, protection against various variants and so on and so forth, remains a compelling proposition.
spk07: Thank you so much. We've got a couple of construct questions. Sean, this is going to come your way. The first one you kind of hit a little bit, but we'll ask the question and get you to expand on your initial answer. The question is, what factors will inform the construct you take into the challenge study and a potential phase three trial? Sean.
spk02: Yeah, I think right now, I think the most important thing from the standpoint of deciding what to take forward in the challenge study is how our mucosal IgA and neutralizing antibodies do against Omicron, as well as, you know, our ability to elicit a CD8 T cell response. Further, the data from the trials where we were boosting subjects that got an mRNA vaccine might provide additional guides to the immune profile, since when we go to challenge, people are already going to have had a vaccine.
spk07: And excellent. And the next question is really about Omicron. It's kind of somewhat similar to one of our analyst questions. We're going to ask it, and you can maybe expand on the other answer that you gave. The question is, if the current S construct is cross-reactive, why are you starting over with an Omicron construct? Wouldn't Omicron be obsolete by the time your construct is complete? Sean?
spk02: Yeah, I think we talked about this a little bit. Maybe I'll be a little tighter in the language. Obviously, we are confident in the cross-reactive responses of our existing constructs. I mean, we certainly have proven that both with the phase one and the phase two. However, I mean, you know, to be scientifically rigorous, we wanted to look at the Omicron constructs, and we're committed to compare them to the other ones, at least preclinically, because, again, we want to make sure that, you know, things are good and we have the best, you know, vaccines going forward. In terms of whether Omicron will be obsolete, well, you know, things change. But I still think, you know, the Omicron family seems to be the one that's popping up more commonly these days.
spk07: Great. Thank you. And the next question, Andre, I'm going to punt over to you. And you've already mentioned that you're going to the G20, but I'll let you expand on this. The question is, do you believe VaxArt will have a place at the table in terms of key government officials recognizing the need for oral vaccines? Andre, please.
spk09: Thank you. Thank you, Brian. I mean, I hope that I provided the answer, which is obviously yes. So we see that there is interest, at least in discussing how our technology, which is fairly unique, can help in this pandemic and future ones. So there are several countries with which we have discussions. We continue to have discussions. And as I said, they focus not only on COVID-19, but beyond COVID-19 on pandemic preparedness. So, you know, we remain excited to have these discussions. We actually feel honored to have some of them, like the invitation I mentioned to the B20. And we do hope that eventually we'll receive some tangible support. But as I mentioned in my opening remarks, you can never be sure that these conversations will turn into something tangible. However, again, what I can tell you right now is that our message about the potential of our platform resonates with many.
spk07: Excellent. Thank you. All right, Sean, this one's going to come back over to you, and it's a question that we get asked quite often here, actually, and the question is, how is Vaxart's oral tablet vaccine differentiated from the intranasal vaccine chemists?
spk02: Yeah, this is a very good question. So, you know, obviously, there has never been a head-to-head comparison between an intranasal and oral vaccine candidate, at least, you know, for COVID-19 or for anything from everything I could see. The limited published intranasal vaccine data that we've seen has not really been that encouraging, to say the least. You know, the immune responses just haven't been that potent from what I can tell. There is an aerosol vaccine. Keep in mind, this is inhaled through an apparatus, not sprayed into the nose. It was approved in China, and there actually are some publications out there, in fact, quite a few. I think our data actually compares quite favorably with the caveat, of course, there's no head-to-head comparison done. I think particularly in the Omicron response in the serum mucosa, I think our data looks actually more compelling. Lastly, while it's true in India and Russia have moved forward with intranasal vaccines, those There's no data really published yet, and I really don't know what the basis for approval was. I think that means it's kind of I'm a little cautious, and I think we should all be a little cautionary, you know, about the fact that the data hasn't been published yet these things are approved.
spk07: Great. Excellent. Thank you so much. Okay. There's a couple of sort of duplicate questions in here. One is what's the prospect for U.S. or international government funding? And, Andre, I think you've handled that. just recently. The next one was, what's your thoughts on a regulatory pathway? I don't know if you want to add any more on what you've already previously mentioned. If not, we can move on.
spk09: No, no. I mean, I try to address that. I don't know if I can do any better. Again, it's hard to speculate. Decisions could be different in various regions around the world. and they depend on how well we're going to do in this challenge study and what the perceived unmet need will be at the time. But we continue to be encouraged by the fact that we have a very differentiated platform here, and the data so far continues to be very encouraging.
spk07: Thank you. I think we've got time for a couple more questions here. This one's coming in about the workshop, Sean, so it's going to come to you that you're just in the midst of doing. I noted the November 7th, 8th workshop on mucosal vaccines for COVID that Dr. Tucker is speaking at. It seems like a fantastic forum to educate the scientific community and pandemic preparedness community on the benefits of VaxArts candidates and create some buzz for the company. It would seem natural to alert investors in Wall Street to this, but I haven't seen a press release. Help me understand the importance of this event. Sean, please, if you could comment about the meeting that you're just wrapping up.
spk02: Sir, I think you were referring to the NIH mucosal vaccines for SARS-CoV-2 scientific gaps in our opportunities. It's a workshop, not really a public conference, but let me tell you why it was important. The good news is our vaccine had strong enough human data to prompt an invitation to the event. And I was able to discuss our orally administered vaccine could provoke a protective response against a respiratory pathogen, talk about our flu study, and also talk about the very potent nasal IgA response we get. And I think, you know, it was well received and, you know, I was happy to be invited to participate. It was a big step forward for us, I think, to get our information out there.
spk07: Fantastic. And there's a couple last norovirus questions that I'm going to ask. And, Sean, this one's going to start for you. I think we've already mentioned this, but please, if you could elaborate just a little bit. So, the question is, would we see any preliminary data on the Neural Challenge Study prior to Q1 2023?
spk02: Yeah, this study is a double-blind placebo-controlled study to prevent bias in the data. We aren't going to, you know, unblind it until it's ready to be unblinded. And then at that point, we will be able to see, you know, how well our vaccine did and really understand the data.
spk07: Excellent. And then the last question on norovirus, what's the potential next steps for this program following the challenge study?
spk02: Sure. We've already announced we have plans to move forward with the bivalent study. And again, just to make sure everybody knows that we've covered both the G1 and G2-4 strains of norovirus, which are responsible for the majority of disease in adults for this confirmation. And the study is expected to begin late this year or early next year. And this is a major step forward for the company just before we go to the end of Phase 2 meeting with the FDA. Okay.
spk07: Great. Thank you so much. So that's the end of our Q&A, and this concludes today's call. I want to thank all the participants on today's call very much for their time in listening to VaxArt's story. Thank you. Bye-bye.
Disclaimer