Vaxart, Inc. (NASDAQ:VXRT) Q3 2022 Earnings Call Transcript

Vaxart, Inc. (NASDAQ:VXRT) Q3 2022 Earnings Call Transcript November 8, 2022

Vaxart, Inc. beats earnings expectations. Reported EPS is $-0.23, expectations were $-0.24.

Operator: Greetings, and welcome to the Vaxart’s Third Quarter 2022 Business Update and Financial Results Conference Call. A question-and-answer session will follow management’s opening remarks. . 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, Business Operations.

Brant Biehn: 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 this conference call — 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?

Cezar Floroiu: 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 authorize 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 have 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 is here, how tomorrow’s global healthcare architecture could help the world recover together, recover stronger, which is one of the mottos of this year’s G-20. 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 there is real interest in the transformation nature of our platform and our programs. Our lower decentralized 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 produce 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 these results even more interesting is that it showed that the oral pill protected by working very differently than the injectable. Vaxart vaccine produced six to 10 times less serum antibodies than injectable. Yet it protected as well, presumably because it also activated because of immunity.

Let me say this again, Vaxart vaccine produced up to 10 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 that use for injectables, mainly 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 variance, reduction in viral transmission, longer protection, and the 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. While, Sean 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, 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 shelling was observed in flue and COVID-19 study.

Durable protection or immune responses were seen in flu, norovirus, and COVID-19 trial. 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 subs. ‘ 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. And as I said, our platforms 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 does 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 James Cummings, Dr. James Cummings will discuss our clinical trial program. Sean?

Sean Tucker : 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 potentially 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 and all these responses are highly cross reactive against all the Coronavirus we tested again, not just SARS-CoV-2 but some really divergent Coronavirus as a 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 2 study, this is the S protein only study and it emphasizes the point again about cross reactivity. Because the responses in vaccinated individuals were cross reacted to other SARS-CoV-2 and the variants. For example 50% of the A mucosal response to Wuhan, and in fact, 55% of those subjects had a mucosal response to the more what I would say, present circulating strain to Omicron, BA 4 and BA 5. So effectively, every one that we induced in the mucosal response can Wuhan also responded to the more 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 they will get longer duration immunity, and we believe it’d 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 1 norovirus trial, we saw a rise in fecal IgA responses that would durable for greater than six months. In our flu challenge study, this is one the sponsored by BARDA, our oral vaccine had 39% protective against 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 is what challenge studies usually look at.

We looked at this alleged longer time point. Also, as I mentioned earlier, that COVID-19 phase one 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 a potential induced or reduce transmission, the proposed mechanism by inducing a mucosal IgA response, this hinders the virus spread to other individuals. If there’s a substantial mucosal IV a response to the nose, this IgA can hit a bit shedding of respiratory pathogen, potentially blocking the productive release of virus. Here’s some of the highlights of our data, in our Phase 2 challenge study, and then analysis conducted by BARDA, there was an 80% chance of 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 are vaccine candidate delivered orally or intra nasally limited airborne transmission of SARS-CoV-2 t unvaccinated animals, animals have never seen vaccine. And let me highlight this point again, the opportunity to reduce transmission we have major advantage in the fight against COVID-19. Because if you can get it, you can reduce the speed of the virus propagate to 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 to be low and are not up to the virus will essentially burnout. And study after study Vaxart has built a compelling case for 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 for the world. Furthermore, bypassing the need for an expensive cold chain storage, hundreds of millions of people in developing countries who cannot readily access 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 talent 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?

James Cummings : 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 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 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 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 with 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’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 Andrei, for some closing remarks, Andrei.

Cezar Floroiu: 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 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 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 for 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.

Q&A Session

Operator: Thank you, the floor is now open for questions. Our first question comes from Charles Duncan with Cantor Fitzgerald. Please state your question.

Pete Stavropoulos: Hi. This is Pete Stavropoulos on for Charles, let’s 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 two with the bivalent vaccine candidate in 4Q or 1Q ’23. Sort of can you speculate on the size and duration of the study? And will you be looking at immunogenicity and efficacy or one of the other and how will this differ from the other studies that you conducted in norovirus

Cezar Floroiu: Sean, do you want to take this? Thank you for your question. Sean you want to take this?

Sean Tucker : 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 and placebo. Again, as I mentioned before, it’ll 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.

Pete Stavropoulos: All right, thanks. And in terms of the challenge of an oral norovirus challenge study? Can you sort of make a comment sort of how enrollment is proceeding? And are you on track to move on later, in 1Q, ’23?

Sean Tucker : Yeah, it’s enrolling at a reasonable rate. Our expectation is that we will see data, Q1 of next year.

Pete Stavropoulos: All right, great.

Cezar Floroiu: So we said we’re still on track with previous guidance to report a data end of Q1, early Q2 next year.

Pete Stavropoulos: Okay. And actually, back to the Phase 2, we were just discussing a minute ago, what are the gating factors? And have you actually manufactured the required materials for the study?

Cezar Floroiu: I don’t know that there are any gating factors. We — again, we announced that we are on track with plans to start at end of Q4, early Q1 of this year.

Pete Stavropoulos: Okay, thanks. And one question on COVID program, there’s data out there and also authorizations for Omicron specific boosters. Although really different vaccine platforms, how does this sort of impact your thoughts on your program and sort of which candidates you’re going to bring forward?

Sean Tucker : Yeah, I mean, obviously, there’s definitely people that are gone with Omicron. Specific. I think the data out there is a little mixed, in terms of the other is important. Again, what we said we were going to do is we’re going to 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 mucosae, and certainly that is weighing on us a little bit from the standpoint of making decision of how to 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 were can be protected in a challenge model, but whether they — what the correlates of protection could are from the mucosal vaccine.

Pete Stavropoulos: Alright, thank you. Sorry.

Cezar Floroiu: 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 variant of the past. 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 especially 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 when you keep running after a pandemic that evolves faster than we can vaccinate.

Pete Stavropoulos: Got you. Thank you for the added color and definitely looking forward to some data from the human challenge studies.

Operator: Our next question comes from Mayank Mamtani with B. Riley Securities. Please state your question.

Sahil Kazmi: Hi, good afternoon team. This is Sahil Kazmi on for Mayank, asking a few questions here. I really appreciate the comprehensive update. And 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 getting more prevalent. Just curious how far along you and your partners are with identifying virus dose use for the challenge study?

Cezar Floroiu: Hi, don’t this is — okay, Sean you take it. ‘

Sean Tucker : Yeah, I don’t — yeah, right now what we’re doing is we’re certainly looking at a BA5 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 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 actually quite well against the Omicron BA4, 5, and I expect that will happen, if it will okay, as well against the BQ as well.

Sahil Kazmi: 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’s the threshold for highly attractive profile might look like? Maybe putting in context, but we’ve seen some of your peers do in the field?

Sean Tucker : Sure, I’ll take this question. One of the things that, of course, is that when we’re using the challenge that if you’re using really, really high doses of virus, and so the expectation is that it will the challenge results will be something in terms of percent efficacy will be on what I would call 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, but RX and — and again there’s 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 on that vaccine was about 40% some odd. So, again, challenge models are great from the standpoint of understanding, can your vaccines protective, and what are the correlates that you are using a quite a large dose as part of that process?

Sahil Kazmi: Great, thank you. I really appreciate the added color. Yeah. That was great. Thank you very much, and congratulations on all the progress. Appreciate you taking our questions. And best of luck, Andrei at the G20.

Cezar Floroiu: Thank you so much.

Operator: Our next question comes from the with Brookline Capital. Please state your question.

Unidentified Analyst: Hi, thank you for taking my question. So as you may know, Oculus Holdings recently announced a collaboration CSL Seqirus 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 web technologies among global companies? I mean, what are your thoughts on it?

Cezar Floroiu: Yeah, thank you. Thank you for the question. So this is Andrei. I think it definitely does. And if you saw that agreement, it was about COVID, as well as influenza and was what I 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 interest from investors in COVID, specifically may weather flow. But if you talk to healthcare bodies and governments, I think there has been 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 vaccines is not the best way to go. And therefore, we need newer technologies. So I don’t know if this answers your question.

Unidentified Analyst: Yeah, it does. Thank you very much.

Cezar Floroiu: I would add that we hope that our science will see that this will also translate in increased interest from large biopharma in the sector.

Unidentified Analyst: Right. Thank you, Andrei.

Operator: At this time, there are no 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.

Brant Biehn : 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 Andrei, this first one was what’s your approach to potential partnerships for either COVID-19 or norovirus programs? I think you’ve covered a little bit of that. But do you want to expand on that answer that you just gave?

Cezar Floroiu: Well, maybe just a little bit. I mean, I’m going to say the obvious which is that what we have said in the past that we can 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. So we continue to be open to exploring partnerships, whether here in the U.S. or abroad.

Brant Biehn : Thank you. Sean, this next one is going to be for you. And the question is where do you see Vaxart’s COVID-19 candidates fitting into the next gen vaccine landscape? Sean, please.

Sean Tucker : Sure. Well, we certainly see our pill-based vaccine as a standalone vaccine for those who haven’t been immunized whether because of needle fare because of large logistics requirements, such as cold chain medical supplies, personnel. Obviously in the US and other countries, a lot of 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’s complimentary other vaccines. Now, we certainly have tested ours as a bit booster with the mRNAs. And we know we can make mucosal immune responses. And of course, we think that it might be better from the standpoint of creating and bicoastal cross variant protection and potentially reducing transmission.

Brant Biehn : Excellent, thank you, Sean. And this absolutely next one will 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?

Sean Tucker : Sure, thanks. Well, obviously, I think we have in the past and looking at targets that are essentially viral-based. But certainly I think that any vaccine that can 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 started with something that’s cervical dysplasia. So again, there’s lots of different targets we can go for. And, because the platform is very easy to use, I’m not going to discuss a lot of new ones today.

Brant Biehn : 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?

Cezar Floroiu: Sure. 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.

Brant Biehn : Excellent. And sort of the I guess we kind of head 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.

James Cummings : 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 the governments around the world. We think that our platform presents very compelling potential advantages to current technology. So 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 as we’ve done in the past, opportunistically accessing capital market.

Brant Biehn : Great, thanks so much. So there’s a lot of questions coming in for COVID-19. We’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 providing rationale for any changes from previous expectations?

Sean Tucker : I thought like 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 were working on the research. We plan to move forward to select our construct for our plan, hVIVO COVID challenge in the second half of 2023. Obviously, the strong cross-reactive responses against Omicron we solve our Phase 2 trial in the Wuhan. This is the Wuhan makes a strong candidate for the challenge study. And of course, we think this could allow us to speed up our development pathway.

Brant Biehn : Excellent. Thank you. And sort of a follow on question really is is the same question about Andrei we’ll get this one over to you, what’s the timing for the challenge study commenced. But I think you’ve hit on that already. And Dr. Cummings also hit on it. But if he could just reiterate what our timing is for the challenge study for COVID? Are we on track for the second half of 2023?

James Cummings : Sure, 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’re also looking at ways that would make would — make it possible for us to start that trial sooner. And so once we identify those paths will obviously make an announcement.

Brant Biehn : Great. Okay, Sean, this next one’s for you. As to do 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?

Sean Tucker : Yeah, I expect that we will have new site 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 that we’ve gained. And new things coming up, and when there’s something interesting to release, we will release it when it’s available.

Brant Biehn : Thank you. Andrei, this next one’s going to come to you and back to the COVID challenge study again. So if COVID challenge study results are positive, do you see an accelerated path for vaccine approval?

Cezar Floroiu: Well, so 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 of the FDA, and outside of the U.S. to look at global application of our platforms 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 really is really a challenging question to answer now, but we remained very confident that the benefits of needle free pill based vaccine that can provide many of the advantages that we talked about durable protection, protection against various variants, and so on and so forth, and remains a compelling proposition.

Brant Biehn : 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 a last question, and it gets 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 3 trial? Sean.

Sean Tucker : Yeah, I think right now. I think the most important thing from the standpoint of deciding what to take forward and challenge study is how are bicoastal IgA and neutralizing antibodies do against Omicron, as well as you know, our ability to elicit CD8 T-cell response. Further data from trials were boosting subjects that gotten an mRNA vaccine might provide additional guidance in the profile, since when we go challenge, people are already going to have add a vaccine.

Brant Biehn : And excellent. And the next question is really about Omicron is kind of somewhat similar to one of our analyst’s questions when they ask it and they 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.

Sean Tucker : Yeah, I think we talked about this a little bit. Maybe I’ll be a little tighter the language, obviously, we are constant and the cross reactive responses of our existing constructs. I mean, we certainly have proven that both with Phase 1 and the Phase 2. However, I mean to be scientifically rigorous, we wanted to look at the Omicron constructs, and we’re fitted to compare them to the other ones, at least preclinically. Because again, we want to make sure that things are good, and we have the best vaccines going forward. In terms of whether Omicron will be obsolete, well things change, but I still think the Omicron family seems to be the one that’s popping up more commonly these days. So.

Brant Biehn : Great, thank you. And then the next question Andrei, I point over to you and you’ve already mentioned that 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? So, Andrei, please.

Cezar Floroiu: Thank you. Thank you, Brant. 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 we remain excited to have these discussions. We actually feel honored to have some of them like the invitation I mentioned to the G20. 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.

Brant Biehn : 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. And the question is, how is Vaxart’s oral tablet vaccine differentiated from the intra-nasal vaccine candidates?

Sean Tucker : Yeah, this is a very good question. So obviously, there has never been a head-to-head comparison between an intra nasal and oral vaccine candidate least for COVID-19 or anything is from what everything I could see. The limited published inter nasal vaccine data that we’ve seen is not really 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, keep in mind, this is not 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 not — no head-to-head comparison done, I think particularly Omicron response in the serum mucosa, I think our data looks actually more compelling.

Lastly, while it’s true in Indian Russia has 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 about the fact that the data hasn’t been published yet to get things are approved.

Brant Biehn : 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 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. If not, we can move on

Cezar Floroiu: I mean, I try to address that. I don’t know if I can do any better. If it’s, again — it’s hard to speculate. The seasons 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 needs will be at a 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.

Brant Biehn : 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 as it seems like a fantastic forum to educate the scientific community and 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 helped me understand the importance of this event. Sean, please, if you could comment about the meeting that you’re just wrapping up.

Sean Tucker : Sure, I think you referring to the NIH Mucosal Vaccine for SARS-CoV-2 scientific gaps and opportunities. It’s a workshop not really a public conference, and but let me tell you why it was important. The good news is our vaccine had strong enough human data for prompt invitation 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 it was well received and it was happy to be invited to participate. It was a big step forward for us so I think to get our information out there.

Brant Biehn : Fantastic. And there’s a couple of last norovirus questions that I’m going to ask to Sean. This one is going to 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?

Sean Tucker : Yeah, this study is a double blind placebo controlled study to prevent bias in the data. We aren’t going to unblinded it until it’s ready to be unblinded. And then at that point, we will be able to see how well our vaccine did and really understand the data.

Brant Biehn : Excellent. And then the last question on norovirus, what’s the potential next steps for this program following the challenge study?

Sean Tucker : Sure, we’ve already announced we have plans to move forward to bivalent study. And again, just to make sure everybody knows that, that we’ve covered both the G1 and G2 strains in norovirus, which were responsible for the majority of disease and adults for dose confirmation. And the study is expected began late this year or early next year. So — and this is a major step forward from the standpoint of the company, just before we go to the end of Phase 2 meeting with the FDA.

Brant Biehn : 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 story. Thank you. Bye-bye.