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@vaxart.com. As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Brant Biehn, Senior Vice President of Business Operations.
Good afternoon, and welcome to today's call. Joining us from Vaxart are Andrei Floroiu, 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, 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 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 Factors 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 Andrei Floroiu. Andrei?
Thank you, Brant, 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 the 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- 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. I'd like to again thank our shareholders for their support and tell them that their trust had not been misplaced. Now, 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.
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, Vaxart is much more than just its COVID-19 program. 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 Vaxart. The other is the broader promise that Vaxart's 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.
This week I will go to Indonesia to discuss with world political and business leaders the role that Vaxart'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, Vaxart 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 mottos of this year's G20. 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 ones.
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. 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 leading injectable in humans against a 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. What makes this result even more interesting is that it showed that the oral pill protected by working very differently than the injectable. Vaxart's vaccine produced 6-10 x less serum antibodies than the injectable. Yet it protected as well, presumably because it also activated mucosal immunity. Let me say this again. Vaxart vaccine produced up to 10 x less serum antibodies than the injectable, 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 tolerability. Improvements on even one of these dimensions will be significant. Yet 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. 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. To date, the benign tolerability of the vaccine candidates we have produced using our platform 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 produced across our many programs, rather than by focusing on any individual program.
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, comfortable 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 endpoint, namely assessing whether vaccines can protect against infection, rather than just looking at immune responses. 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. Sean?
Thanks, Andrei. As you mentioned, we have several key differentiators of our VAAST platform. 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 I study of our S+ N COVID-19 vaccine construct, 46% of the subjects had a 1.5-fold increase or better against SARS-CoV-2 in the nasal IgA responses, and all 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. 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 II 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-2 and the variants. For example, 50% of the subjects had a mucosal response to Wuhan. In fact, 55% of those subjects had a mucosal response to the more, you know, what I would say, present circulating strain of Omicron BA.4/5. Effectively, everyone that we induced a mucosal response against Wuhan also responded to the more prevalent or the strains that are going on now.
Second, let me tell you a key advantage, another key advantage of our platform. We believe it will get longer duration immunity, and we believe it'll be longer than 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. Here's some of the highlights of our data. In our first phase I 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 90-120 days after vaccination, not the typical 30 days as what challenge studies usually look at. We looked at this a much longer time point. Also, as I mentioned earlier, that COVID-19 phase I study S + 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 induce or reduce 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, essentially blocking the productive release of virus. Here's some of the highlights of our data. In our phase II challenge study, in 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 that never seen vaccine. 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. 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 can deliver to society and to shareholders. We have the advantage of being further ahead of 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, bypassing the need for an expensive cold chain storage, hundreds of millions of people in developing countries who cannot readily access injectables 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. There is that last mile 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?
Hey, thanks, Sean. I'll begin with our COVID-19 clinical vaccine program. In early September, we reported top-line data from part 1 of our phase II 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 of 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 hVIVO 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 greatest likelihood of success in a phase III 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 Ib trial of our norovirus vaccine candidate in subjects aged 55-80 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 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 II 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 II 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. Now I'll turn the call back to Andrei for some closing remarks. Andrei?
Thank you, James. Also thank you, Sean, for reviewing our clinical data and our progress and outlining some of the key milestones ahead for us. 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 30th, 2022, we had cash and cash equivalents 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?
Thank you. The floor is now open for questions. If you have a question, please press star one on your telephone keypad at this time. Please hold while we poll for questions. Our first question comes from Charles Duncan with Cantor Fitzgerald, please state your question.
Hi, this is Pete Stavropoulos on for Charles. I would like to say congratulations on all the progress made this past quarter. I have a question on the norovirus program. I know that you're planning to initiate the phase II with the bivalent vaccine candidate in Q4 or Q1 2023. 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 norovirus?
Sean, you wanna take this? Pete, thank you for your question. Sean, do you wanna take this?
Yeah. Again, Pete, thanks for the question. The study is immunogenicity study. It's approximately 600 subjects. I believe the plan, it will be enrolling two to one, two different dose levels and 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 as the basis for going forward to the FDA with an end-of-phase II meeting.
All right. Thanks. In terms of the challenge of 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 announce data in Q1 2023?
Yeah. It's enrolling at a reasonable rate. Our expectation is that we will see data, you know, Q1, you know, of next year.
All right, great.
We said, Pete, we are still on track with previous guidance, which is to report data end of Q1, early Q2 of next year.
Okay. Actually back to the phase II we were just discussing a minute ago. You know, what are the gating factors, and have you actually manufactured the required materials for the study?
I don't know that there are any gating factors. You know, we again announced that we are on track with plans to start that end of Q4, early Q1 of this year.
Okay, thanks. 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 gonna bring forward?
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, as they're as important. Again, what we said we were going to do is we were gonna take a look at our data from our phase I, S and N, phase II, 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 wanna point out is that we did see some strong cross-reactive responses against Omicron in that phase II study, both in sera and mucosa.
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 not only that they could be protective, you know, in a challenge model, but what the correlates of protection are from the mucosal vaccine.
All right. Thank you.
Pete,
Yeah. Sorry.
Pete, if I can add something here. I think we all know that the shortcomings of the injectable vaccines is that they are backwards looking if you want. They are designed about for a variant of the past, right? 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 gonna protect against emerging variants.
With mucosal 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.
Gotcha. Thank you for the added color and definitely looking forward to some data from the human challenge studies.
Our next question comes from Mayank Mamtani with B. Riley Securities. Please state your question.
Hi, good afternoon, team. This is Tahira Kazmi for 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 used for the challenge study.
Okay, Sean, you take it.
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. Again, what we will do is we will start to monitor our candidates, you know, and how their immune responses differ from the, you know, from that, from those variants as well. One thing to note, and you know, and Andrei brought this up earlier, is that, you know, we have noticed that our vaccine seems to do actually quite well against the Omicron BA.4/5, and I expect that will happen. It'll look okay as well against the BQ as well.
Excellent. Thank you. As it pertains to the norovirus program, and the challenge study that we're gonna 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 of what we've seen some of your peers do in the field.
Sure. I'll take this question. One of the things that, of course, is that, you know, when we're using these challenge studies, we're using, you know, really high doses of virus. The expectation is that the challenge results will be something, you know, in terms of a percent efficacy will be on the, what I would call low end. It would be something on the order of 40%-60%. Having said that, you know, it could be higher as well. But
Rx and again, you know, there's the one challenge study that's been published that was successful from LigoCyte, you know, and the GI.1 that was done several years ago, and I believe the efficacy on that vaccine was about 40%-some odd . Again, challenge models are great from the standpoint of understanding can your vaccine be protective and what are the correlates, but are using quite a large dose as part of that process.
Great. Thank you. I really appreciate the added color.
Hope that answered your question.
Yes. No, that's great. Thank you very much. Congratulations on all the progress. Appreciate you taking our questions, and, best of luck, Andrei Floroiu, at the G20.
Thank you so much.
Our next question comes from Kemp Dolliver with Brookline Capital. Please state your question.
Hi, thank you for taking my question. As you may know, Arcturus Therapeutics Holdings Inc. recently announced a collaboration with CSL Seqirus, a global vaccine company, to develop and commercialize self-amplifying mRNA vaccines. 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?
Yeah, thank you. Thank you for the question. This is Andrei . I think it definitely does. If you saw that agreement, it was about COVID as well as influenza and was, you know, what I would call pandemic preparedness oriented. 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. I think, you know, the interest from investors in COVID specifically may ebb and 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.
There is a growing realization that fighting these pandemics with just the current generation injectable vaccines is not the best way to go, and therefore we need newer technologies. I don't know if this answers your question.
Yeah, it does. Thank you very much. I'll get back to you.
Well, I would add that we hope, and there are signs that we see that this will also translate into increased interest from, you know, large biopharma in the sector.
Great. Thank you, Andrei.
At this time, there are no more questions in the queue. I will now turn the call to Brant Biehn, Senior Vice President, Business Operations, to moderate the investor questions portion of the call.
Thank you very much. Now we'll turn to questions from individual investors. 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 wanna push out or expand Andrei. 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?
Well, maybe just a little bit. I mean, I'm gonna state the obvious, which is that what we had 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. We continue to be open to exploring partnerships, whether here in the US or abroad.
Thank you. Sean, this next one's gonna be for you. The question is where do you see Vaxart's COVID-19 candidate fitting into the next gen vaccine landscape? Sean, please.
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 and, or infected, so it's really gonna be a booster in a lot of populations. 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. Of course, we think that, you know, it might be better from the standpoint of creating a mucosal cross-variant protection and potentially reduce some transmission.
Excellent. Thank you, Sean. This actually next one will be for you as well. What other infectious diseases would be good candidates for the VAAST platform in the future? The second part of this, and are you looking at any specific target indications? Sean?
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 a 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'd start with that's cervical dysplasia. Again, there's lots of different targets we could go for and, you know, because the platform's very easy to use, I'm not gonna discuss a lot of new ones today.
Great. Thanks, Sean. Andrei, 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.
Sure, Brant. 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. That includes aggressively progressing our two lead clinical programs, which is norovirus and COVID-19. I wanna 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. The second is that there are levers that we could pull to extend this runway significantly if we ever think that would be appropriate.
Excellent. The I guess you kind of hit on the next question a little bit. What are the plans for funding the company? Maybe just expand that last bullet a little bit, I guess.
We continue to pursue various funding sources available to us. I mentioned in my opening remarks that we continue to be engaged with the governments around the world. We think that our platform presents very compelling potential advantages to current technology. I would 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.
Great. Thanks so much. 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 so much here. Sean, the first one I'm gonna 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.
I'd both like to see the COVID vaccine construct, well, it's based on our data from the phase I S+N, the phase II S-only, and the newer constructs we're working on for research. We plan to move forward to select our construct for our planned hVIVO COVID challenge in the second half of 2023. Obviously the strong cross-reactive responses against Omicron we saw from our phase II trial and the Wuhan, and this is with the Wuhan trial, makes this a strong candidate for the challenge study. Of course, we think this could allow us to speed up our development pathway.
Excellent. Thank you. Sort of a follow-on question really is just the same question about Andrei Floroiu, 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 then Dr. Cummings also hit on it, but if you could just reiterate what our timing is for the challenge study for COVID. Are we on track for second half of 2023?
Sure. Thank you, Brant. We had said that we're gonna 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. Once we identify those paths, we'll you know, obviously, make an announcement.
Great. Okay, Sean, this next one's for you. It has to do with the phase IIa trial for COVID-19. The question is, will you be releasing additional insights from the phase IIa trial beyond the top-line data that you announced in September? If so, when? Sean.
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. 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.
Great. Thank you. Andrei, this next one's gonna come to you and, it's back to the COVID challenge study again. If COVID challenge study results are positive, do you see an accelerated path for vaccine approval?
A bit of a, you know, challenging question because it really depends on our results from that challenge study. It also depends on the state of the pandemic at that time. You know, we are in touch with several regulatory authorities both here in the States with the FDA and outside of the U.S., to look at global application of our platforms against COVID-19. As we've seen during this pandemic, you know, 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.
You know, it's really a challenging question to answer now, but we remain very confident that the benefits of a needle-free, pill-based vaccine that can provide many of the advantages that we talked about, you know, durable protection, a protection against various variants and so on and so forth, remains a compelling proposition.
Thank you so much. We've got a couple of construct questions. Sean, this is gonna 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 III trial, Sean?
Yeah. I think right now, I think the most important thing from the standpoint of deciding what to take forward 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 trial data from the trials where we're boosting subjects that got an mRNA vaccine might provide additional guidance to immune profile, since when we go challenge, people are already gonna have had a vaccine.
Excellent. The next question is really about Omicron. It's kind of somewhat similar to one of our analyst questions. We're gonna 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?
Yeah. I think we talked about this a little bit. Maybe I'll be a little tighter with 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 I and the phase II. 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 pre-clinically, 'cause again, we wanna 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, so.
Great. Thank you. Then the next question, Andrei, I'm gonna 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, Andrei, please?
Thank you. Thank you, Brant. I mean, I hope that I provided the answer, which is obviously yes. 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. 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. You know, we remain excited to have these discussions. We actually feel, you know, honored to have some of them, like the invitation I mentioned to the B20. We do hope that eventually we'll receive some tangible support.
As I mentioned in my opening remarks, you know, 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.
Excellent. Thank you. All right, Sean, this one's gonna come back over to you, and it's a question that we get quite often here, actually. The question is, how is Vaxart's oral tablet vaccine differentiated from the intranasal vaccine candidates?
Yeah, this is a very good question. 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 any, or well, 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 immunogenic 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 and mucosal, I think our data looks actually more compelling. Lastly, while it's true that India and Russia have moved forward with intranasal vaccines, 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 cautious, you know, about the fact that the data hasn't been published, yet these things are approved.
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 US or international government funding? Andrei, I think you've handled that just recently. The next one was, what's your thoughts on the regulatory pathway? I don't know if you wanna add any more on what you've already previously mentioned. If not, we can move on.
No. I mean, I tried to address that. I don't know if I can do any better. It's again, it's hard to speculate. Decisions could be different in various regions around the world, and they depend on how well we're gonna do in this challenge study and what the perceived unmet needs will be at the time. 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.
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 gonna come to you that you're just in the midst of doing. I noted the November seventh, eighth 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 Vaxart's candidates and create some buzz for the company. It would seem natural to alert investors on 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.
Sure. I think you're referring to the NIH mucosal vaccines for SARS-CoV-2, scientific gaps and 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 how 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. 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.
Fantastic. There's a couple last norovirus questions that I'm gonna ask. Sean, this one's gonna start for you. I think we've already mentioned this, but please, if you could elaborate just a little bit. The question is, would we see any preliminary data on the noro challenge study prior to Q1 2023?
Yeah. This study is a double blind placebo-controlled study to prevent bias in the data. We aren't gonna unblind it, you know, 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.
Excellent. The last question on norovirus. What's the potential next steps for this program following the challenge study?
Sure. We've already announced we have plans to move forward with the bivalent study. Again, just to make sure everybody knows that we've covered both the GI.1 and GII.4 strains of norovirus, which were responsible for the majority of disease in adults for this confirmation. The study is expected to begin late this year or early next year. This is a major step forward from the standpoint of the company just before we go to, you know, the end of phase II meeting with the FDA.
Great. Thank you so much. That's the end of our Q&A, and this concludes today's call. I wanna thank all the participants on today's call very much for their time, in listening to Vaxart's story. Thank you. Bye-bye.
Thank you.