Transcript
Greetings, and welcome to Vaxart's Third Quarter 2022 Business Update and Financial Results Conference Call. A question-and-answer session will follow management's opening remarks. This conference is being recorded. I would now like to turn the webcast over to your host, Brant Biehn, Senior Vice President, 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 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 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, except as required by law. I'll now turn the call over to Andrei Floroiu. Andrei?
Thank you. 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 to 250 million shares. During the proxy voting process, many of our individual shareholders were concerned that passing this proposal would lead to 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 has not been misplaced. Now, let me tell you why we're very excited about the work we are doing at Vaxart, and about the significant potential impact 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, Vaxart 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 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 G-20 Summit, more specifically the B-20 portion of the G-20. So this week, I'll 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, namely how tomorrow's global healthcare architecture could help the world recover together and recover stronger, which is one of the mottos of this year's G-20. 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. 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 there is real interest in the transformative nature of our platform and our programs, I must 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 have 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 provided as well as a commercial vaccine that needs to be administered by injection. And what makes these results even more interesting is that it showed that the oral pill protected by working very differently than the injectable. Vaxart's vaccine produced six to ten times less serum antibodies than injectable. Yet, it protected as well, presumably because it also activated other arms of the immune system. Let me say this again: Vaxart's vaccine produced up to ten times less serum antibodies than the injectable yet 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 used for injectables, mainly looking only at serum data, while 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 vaccines in four areas: broad cross-reactivity against variants, reduction in viral transmission, longer protection, and improved tolerability. Improvements in 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. While Sean Tucker will review this data in more detail, 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 two of our COVID-19 clinical trials. Reduction in transmission or viral shedding was observed in both 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 platform is supported by 16 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 have 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're so excited about what Vaxart is doing today: a truly transformational potential supported by growing data across programs, profitable financial resources, a very strong team, and significant clinical results in 2023. These results 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 Dr. James Cummings will discuss our clinical trial program. Sean?
Thanks, Andrei. 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 a broader immunogenicity than the injected alternatives. For example, in the Phase 1 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. Moreover, all these responses are highly cross-reactive against all the coronaviruses we tested again, not just SARS-CoV-2 but also some really divergent coronaviruses from the beta and 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, 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. Let me tell you a little bit about our COVID-19 Phase 2 study. This is the S protein-only study and it emphasizes the point again about cross-reactivity. The responses in vaccinated individuals were cross-reactive to other SARS-CoV-2 variants. For example, 50% had a mucosal response to the Wuhan strain, and in fact, 55% of those subjects had a mucosal response to the more prevalent circulating strains, Omicron BA 4 and BA 5. So effectively, everyone that we induced in the mucosal response to Wuhan also responded to the more prevalent strains. Second, let me tell you about another key advantage of our platform. We believe that it will provide longer duration immunity than 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 vaccines and the injected influenza vaccines. Here are some of the highlights of our data. In our first Phase 1 norovirus trial, we saw a rise in fecal IgA responses that lasted for greater than six months. In our flu challenge study, which was sponsored by BARDA, our oral vaccine had a 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, which is not the typical 30 days that challenge studies usually look at. We looked at this longer time point. Also, as I mentioned earlier, in that COVID-19 Phase 1 study S+N, we showed nasal IgA responses that remained elevated for over a year. Lastly, in our elderly norovirus study, this is data we released this summer, showing IgA and IgG responses that were still elevated even after 200 days. The third point that differentiates our oral vaccine or pill vaccine platform is the potential to reduce transmission by inducing a mucosal IgA response. This can hinder virus spread to other individuals. Here's some of the highlights of our data. In our Phase 2 challenge study, an analysis conducted by BARDA showed an 80% chance that our oral vaccines significantly reduce 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 had never seen a vaccine. Let me highlight this point again, the opportunity to reduce transmission presents a major advantage in the fight against COVID-19. If we can reduce the spread of the virus, fewer people will get infected at once, which will alleviate pressure on hospital care and other critical resources devoted to handling sick patients. If we can reduce transmission sufficiently, it could result in the virus essentially burning out. Study after study, Vaxart has built a compelling case for 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 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 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 also that last bottleneck 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 the call to 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 one of our Phase 2 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 commonly reported in the clinical studies of 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 study's following after that challenge. I can tell you we are committed to developing the candidate with the greatest likelihood of success in a Phase 3 study. Regarding the study in India, 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 on 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 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 2 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 candidates. We have a prespecified utility analysis of our study reporting shortly, and if that is positive, we expect to report preliminary data from our ongoing Phase 2 norovirus challenge study in late first quarter or early second quarter of 2023. We are 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 Andrei for some closing remarks. Andrei?
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 have 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 that excitement as we build on our momentum and advance our oral pill vaccine. 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.
Thank you, we are now ready to take questions. Our first question is from Charles Duncan with Cantor Fitzgerald. Please go ahead with your question.
Hi. This is Pete Stavropoulos on for Charles. 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 two with the bivalent vaccine candidate in Q4 or Q1 '23. Could you speculate on the size and duration of the study? Will you be looking at immunogenicity and efficacy or one of the other? How will this differ from the other studies that you conducted in norovirus?
Sean, do you want to take this? Thank you for your question. Sean, do you want to take this?
Yeah. Again, Pete, thanks for the question. So the study is an immunogenicity study. It's approximately 600 subjects, I believe the plan is to randomize two to one, two different dose levels and placebo. Again, as I mentioned before, it will be immunogenicity, I expect the readout would be some time 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 to Phase 2 meeting.
All right, thanks. In terms of the challenge of an oral norovirus challenge study? Can you sort of make a comment on how enrollment is proceeding? And are you on track to move on later in Q1 '23?
Yeah, it's enrolling at a reasonable rate. Our expectation is that we will see data in Q1 of next year.
So we said we're still on track with previous guidance to report data at the end of Q1 or early Q2 next year.
Okay, thanks. And one question on the COVID program, there's data out there and also authorizations for Omicron-specific boosters. Although there are really different vaccine platforms, how does this impact your thoughts on your program and sort of which candidates you're going to bring forward?
Yeah, I mean, obviously, there are definitely people that have gone with Omicron-specific vaccines. I think the data out there is a little mixed. Again, what we said we were going to do is take a look at our data from our Phase 1 S and N, Phase 2 S-only, as well as looking at some of these new constructs and making some decisions about how to go forward 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 2 study both in serum and mucosal, and certainly that is weighing on us a little bit from the standpoint of making decisions about the next steps and 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 and show not only that they can protect in a challenge model but also what the correlates of protection could be from the mucosal vaccine.
All right, thank you. Sorry.
If I can add something here. So, I think we all know that the shortcomings of the injectable vaccines are that they are backward-looking. They are designed for a variant of the past. That's one of the reasons why you see uptake in vaccination with the new Omicron or bivalent vaccines being so low because we are not sure how they are going to protect against emerging variants. Because of the immunity potential we have the opportunity here to demonstrate cross-reactivity and to potentially show that you do not need to change vaccines as the variants change. Thus, you get off this hamster wheel of running after a pandemic that evolves faster than we can vaccinate.
Got you. 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 Sahil Kazmi on 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 BA5 representing less than 40% of cases or so and the key point one becoming more prevalent, just curious how far along you and your partners are with identifying virus doses for the challenge study?
Hi, Sean, you take it.
Yeah, right now what we're doing is we're certainly looking at BA5 from the standpoint of the Omicron challenge. We think that's more informative in terms of really testing the vaccine. You're right, BQ is now coming up, and it could be very important. Again, we will start to monitor our candidates and how their immune responses differ from those variants as well. One thing to note, and Andrei brought this up earlier, is that we have noticed that our vaccine seems to do quite well against the Omicron BA4 and BA5, and I expect that will also hold for BQ as well.
Excellent, thank you. And then as it pertains to the norovirus 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 what we've seen some of your peers do in the field?
Sure, I'll take this question. One of the things is that when we're using the challenge, we are using really high doses of virus. Thus, the expectation is that the challenge results will be something in terms of percent efficacy will be on what I would call the low end, it would be something on the order of 40% to 60%. Having said that, we have no idea, it could be higher as well. There is one challenge study that's been published that was successful, but leukocyte and G11 that was done several years ago, and I believe the efficacy of that vaccine was about 40% or so. Again, challenge models are great for understanding the protective capability of your vaccines and the correlates while using a relatively large dose.
Great, thank you. I really appreciate the added color. That was great. Thank you very much, and congratulations on all the progress. Appreciate you taking our questions. Best of luck, Andrei, at the G20.
Thank you so much.
Our next question comes from an unidentified analyst with Brookline Capital. Please state your question.
Hi, thank you for taking my question. As you may know, Oculus Holdings 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 web technologies among global companies? What are your thoughts on it?
Thank you for the question. I think it definitely does. If you saw that agreement, it was about COVID, as well as influenza, and was aimed at pandemic preparedness. I think pandemic preparedness is a theme that we see emerge quite a lot recently, at least in our conversations with various governmental bodies. So I think the interest from investors in COVID could weather. If you talk to healthcare bodies and governments, there has been an increased awareness that we need to be better prepared against potential future waves of COVID, but specifically, or more importantly, against future pandemics. There's a growing realization that fighting these pandemics with just the current generation of injectable vaccines is not the best way forward. Therefore, we need newer technologies. I don't know if this answers your question.
It does, thank you very much.
I would add that we hope that our science will attract increased interest from large biopharma in the sector.
Right. 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 of 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 have already been covered in the analyst questions. I don't know if we want to push out or expand. Andrei, this first one was about your approach to potential partnerships for either COVID-19 or norovirus programs. I think you've covered a bit of that, but do you want to expand on that answer?
Well, maybe just a little bit. I mean, I'm going to say the obvious, which is that we have stated in the past that we are always interested in looking for the best way 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 U.S. or abroad.
Thank you. Sean, this next one is going to be for you. The question is where do you see Vaxart's COVID-19 candidates fitting into the next-gen vaccine landscape? Sean, please.
Sure. We certainly see our pill-based vaccine as a standalone vaccine for those who haven't been immunized, whether because of needle fear, large logistics requirements, such as cold chain, or medical supplies personnel. Obviously, in the U.S. and other countries, many people have already been vaccinated and/or infected, so it's really going to be a booster in a lot of populations. We see it as complementary to other vaccines. We have tested ours as a booster with mRNA vaccines. We know we can elicit mucosal immune responses, and we think it might be better in terms of creating cross-variant protection and potentially reducing transmission.
Excellent, thank you, Sean. This next one will absolutely be for you as well. What other infectious diseases would be good candidates for the Vax platform in the future? And their second part of this are you looking at any specific target indications, Sean?
Sure, thanks. Well, we have in the past looked at targets that are essentially viral-based. Any vaccine that can benefit from a mucosal response could be a really good indication to pursue. Our current vaccine pipeline includes COVID-19, respiratory pathogens, norovirus, enteric, influenza, RSV for respiratory, and HPV, which would address cervical dysplasia. There are lots of different targets we can go for, and the platform is very easy to use. I'm not going to discuss many new ones today.
Great, thanks, Sean. 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. So we ended the third quarter with $114.8 million, which means that we have sufficient financial resources on hand to continue executing our plans into the second half of 2023. This includes aggressively progressing our two lead clinical programs, norovirus and COVID-19. I want to put this into perspective with two additional points. First, we believe we have compelling catalysts in the near to medium term that could create new or more compelling funding opportunities. The second point is that there are levers we could pull to extend this runway significantly if we ever think that would be appropriate.
Excellent. We 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.
Well, we continue to pursue various funding sources available to us. I mentioned in my opening remarks that we stay engaged with governments around the world. We believe that our platform presents very compelling potential advantages over current technology. We remain hopeful that these discussions may at some point result in funding. But again, there is no guarantee, of course. We are also pursuing strategic partnership discussions and, as we've done in the past, opportunistically accessing capital markets.
Great, thanks so much. So there's a lot of questions coming in for COVID-19. We'll try to 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 the rationale for any changes from previous expectations?
Based on our data from the Phase 1 S and N, the Phase 2 S-only and the newer constructs we're working on, we plan to move forward to select our construct for our planned hVIVO COVID challenge in the second half of 2023. The strong cross-reactive responses against Omicron shown in our Phase 2 trial make this a strong candidate for the challenge study. We think this could allow us to speed up our development pathway.
Excellent. Thank you. And sort of a follow-on question really is the same question about Andrei, we'll get this one over to you. What's the timing for the challenge study commencement? But I think you've hit on that already. James Cummings also hit on it. If you could reiterate what our timing is for the challenge study for COVID, are we on track for the second half of 2023?
Sure, thank you, Brant. We said that we're going to initiate this trial in the second half of 2023. We are on track for that and are looking at ways that might make it possible for us to start sooner. Once we identify those paths, we will obviously make an announcement.
Great. Okay, Sean, this next one is for you. It says: Do you plan to release additional insights from the Phase 2 trial beyond the top-line data that you announced in September? If so, when, Sean?
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. We are continuing to analyze the data we've gained and new insights will be released when they become available.
Thank you. Andrei, this next one's going to come to you. If the COVID challenge study results are positive, do you see an accelerated path for vaccine approval?
It's a bit of a challenging question because it depends on our results from that challenge study and the state of the pandemic at that time. We are in touch with several regulatory authorities, both here in the U.S. and outside of the U.S., to look at global applications of our platform against COVID-19. We've seen during this pandemic that these regulatory authorities often make different decisions based on not only the strength of the data but also on how acute their unmet needs are at a time. So, it's a challenging question to answer now, but we remain very confident that the benefits of a needle-free pill-based vaccine can provide many of the advantages we talked about, such as durable protection and protection against various variants, and thus remains a compelling proposition.
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 in the last question, and it asks you to expand on your initial answer. What factors will inform the construct you take into the challenge study and a potential Phase 3 trial?
Yeah, I think right now, the most important factor in deciding what to take forward to the challenge study is how our mucosal IgA and neutralizing antibodies respond against Omicron, as well as our ability to elicit CD8 T-cell responses. Further data from trials in boosting subjects who received an mRNA vaccine might provide additional guidance on what profile we should aim for going into the challenge study.
And excellent. The next question is really about Omicron and somewhat similar to one of our analysts' questions when they asked it, and can you maybe expand on the other answer that you gave? 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?
Yeah, I think we talked about this a little bit. I'll be a bit tighter in my language. Obviously, we are confident in the cross-reactive responses of our existing constructs; we have proven that both with Phase 1 and Phase 2. However, to be scientifically rigorous, we wanted to look at the Omicron constructs and compare them to the other ones, at least preclinically. We want to ensure that we have the best vaccines going forward. In terms of whether Omicron will be obsolete, while things can change, I still think the Omicron family is the one that is appearing most frequently these days.
Great, thank you. And then the next question Andrei, I point over to you and you've already mentioned you're going to the G20. But let's 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 all oral vaccines?
Thank you, Brant. I hope 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. We have discussions with several governments, and as I said, they focus not only on COVID-19 but beyond that, on pandemic preparedness. We remain excited to have these discussions. We actually feel honored to have received an invitation to the G20. We hope that we will receive tangible support eventually. But as I mentioned in my opening remarks, you can never be sure that these conversations will result in something tangible. However, our message about the potential of our platform resonates with many.
Excellent, thank you. All right, Sean, this is going to come back over to you, and it's a question that we get asked 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. There has never been a head-to-head comparison between an intranasal and an oral vaccine candidate, at least for COVID-19 or anything based on that. The limited published intranasal vaccine data that we've seen has not been that encouraging to say the least; the immune responses just haven't been that potent, from what I can tell. There is an aerosol vaccine, which is not sprayed into the nose, but inhaled through an apparatus, that was approved in China. There are some publications out there, in fact, quite a few. I think our data compares quite favorably, with the caveat that no head-to-head comparison has been done. I think, particularly the Omicron response in both serum and mucosa, our data looks compelling. Lastly, while it's true that in India and Russia they've moved forward with intranasal vaccines, there is no published data yet, and I really don't know the basis for approval. I think that means we should be a little cautious.
Great, excellent. Thank you so much. Okay, there are a couple of duplicate questions here. What's the prospect for U.S. or international government funding? Andrei, I think you handled that just recently. The next one was, what's your thoughts on the regulatory pathway? I don't know if you want to add any more on what you've already previously mentioned.
It's again hard to speculate. The seasons could be different in various regions around the world, and they depend on how well we do in this challenge study and what the perceived unmet needs will be at that time. We continue to be encouraged by the fact that we have a very differentiated platform here, and the data so far continue 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's is going to come to you that you're just in the midst of doing a note of the November 7 workshop on mucosal vaccines for COVID that Dr. Tucker is speaking at. It seems like a fantastic forum to educate the scientific community and the pandemic preparedness community on the benefits of vaccines candidates, create some buzz for the company. It would seem natural to alert investors and Wall Street to this. But I haven't seen a press release, help me understand the importance of this event, Sean, please.
Sure, I think you are referring to the NIH Mucosal Vaccine 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 for an invitation to the event. 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 the very potent nasal IgA response we generate. I think it was well received and happy to have participated. It was a big step forward for us to get our information out there.
Fantastic. There are several last norovirus questions that I'm going to ask to Sean. This one is going to start for you. The question is would we see any preliminary data on the norovirus 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 going to unblind it until it's ready to be unblinded. At that point, we will be able to see how well our vaccine performed and understand the data.
Excellent. And then the last question on norovirus, what's the potential next steps for this program following the challenge study?
Sure, we've already announced our plans to proceed with a bivalent study, which covers both G1 and G2 norovirus strains linked to the majority of disease in adults, for dose confirmation. The study is expected to begin late this year or early next year, which is a major step forward for the company before we end up in the Phase 2 meeting with the FDA.
Great, thank you so much. So that's the end of our Q&A. 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.