VXRT - NASDAQ

Greetings, and welcome to the Vaxart Business Update and Second Quarter 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel. Please go ahead.

Good afternoon and welcome to today's call. Joining us from Vaxart are Steven Lo, Chief Executive Officer; Dr. Sean Tucker, Founder and Chief Scientific Officer; Dr. James Cummings, Chief Medical Officer; and Jeroen Grasman, Chief Financial Officer. Before we begin, 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 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 and other risks described in the Risk Factors section of Vaxart's most recently filed annual report on Form 10-K and also on other periodic reports filed with the SEC. Vaxart undertakes no obligation to update any forward-looking statements after the date of this call. I'll now turn the call over to Steven Lo. Steve?

Thanks, Ed, and thanks to all of you for joining us this afternoon. I'll begin today's call with an overview of our business. Then, we'll pass the call to James and Sean for the latest developments of our clinical and preclinical programs. Jeroen will share an update of our financials. And finally, I'll have some comments related to our stock listing before we open the call for your questions. Starting with our COVID-19 clinical program. Last week, we received a second stop work order notice on our Phase IIb trial from Advanced Technology International, or ATI, the Rapid Response Partnership Vehicles consortium management firm funded by BARDA. Like the first stop work order, this came as a surprise to us without any advanced notice. Unlike the first stop work order notice, when we had not yet enrolled anyone in the 10,000-participant cohort. We were glad that this came to us when we had already enrolled approximately 5,000 participants. And the notice allows us to continue the study for those already enrolled. We continue to believe there is huge potential for our promising oral pill vaccine candidate for COVID. Enrollment for this trial was proceeding at a rapid pace since we dosed the first participant in late May. These trends highlight the strong public interest of our oral vaccine platform and for a safe and effective vaccine against the SARS-CoV-2 virus. We agree with Secretary Kennedy's priorities that include the development of safe and effective novel vaccine solutions such as our oral vaccine platform. As a reminder, our trial is designed to assess the safety, immunogenicity and efficacy profiles of our candidate against an mRNA comparator. This trial is specifically designed to provide head-to-head data with the goal of advancing broader and innovative vaccine technologies. Although we were trending towards fully enrolling this trial by mid-Q4 as we had projected or even earlier, we remain encouraged about the prospects of the trial and our vaccine candidate since there will be data on about 5,000 participants. We remain in close touch with our BARDA partners and ATI as they indicated that a follow-up notice with further details will come. I'd like to express my appreciation for the work of our clinical teams and investigators across our sites as they continued the important follow-up work on this trial. We also thank the clinical trial participants whose strong interest is making this key study possible. COVID remains an endemic infection that has a morbidity and mortality profile that is more adverse than flu. And while vaccination has waned, the market opportunity remains quite significant. And of course, we anticipate that our differentiated mechanism of action plus delivery as an oral pill can change the trajectory of vaccine acceptance and convenience. Turning to our norovirus program. In June, we were pleased to report positive Phase I top-line results from our second-generation constructs, which increased norovirus blocking antibodies in both the low and high-dose cohort with the difference reaching statistical significance for the high-dose cohort. Compared to our first-generation constructs, our new constructs were optimized to generate stronger immune responses. We plan to share the complete results of the study in a peer-reviewed journal. But it's encouraging that our second-generation constructs have shown meaningful improvement on an important marker of protection against norovirus infection. And that the data continue to show they are well tolerated with a benign safety profile. We believe this has first-in-class or best-in-class potential as currently, there are no approved vaccines. And other products in development do not have the unique profile as well as delivery advantages of our platform. With continuing outbreaks in the news and a significant burden on society, norovirus represents a significant unmet need. As we have shared before, norovirus is believed to cause 20% of diarrheal disease globally and is the leading cause of acute gastroenteritis or AGE worldwide. This highlights the public health potential of our oral norovirus vaccine. The healthcare economic cost of norovirus infection and associated AGE are estimated at $60 billion worldwide and $10 billion in the United States. This underscores why market research estimates the potential of a multibillion-dollar U.S. market for a safe and effective norovirus vaccine. Following the release of norovirus top line data, our leadership team attended the BIO International Convention in Boston. We held many productive one-on-one partnering discussions throughout the conference. And while it's too early to share specific details about a potential partnership, I'm pleased to share that we have meaningful interest from many parties. We will share more information, of course, if a partnership is achieved. Finally, we are progressing our preclinical research in avian influenza. As Sean will highlight, our new avian influenza vaccine was 100% protective against death in a robust ferret clade 2.3.4.4b challenge model compared with 0% survival in placebo-treated animals. Based on our growing body of data, we believe there is potential for our seasonal and avian influenza vaccine candidates and plan to look for funding to continue development of these programs. Overall, our broad pipeline with programs in norovirus, COVID-19 and influenza have a number of upcoming value-creating milestones. With a platform designed to generate both systemic and mucosal immunity, we believe our oral pill vaccine has the potential to transform global public health and revolutionize distribution and administration. I'll now turn the call over to James for a review of our COVID-19 and norovirus clinical programs. James?

Thanks, Steve, and thanks to everyone for joining today's call. I'll start with an update of our COVID program. After our initial stop work order was lifted in April, we quickly activated our clinical sites, resumed participant screening and initiated dosing in the 10,000-participant cohort, all within about 1 month's time. As Steve mentioned, we were well on our way to achieving our enrollment targets with about half of the participants enrolled earlier this month. However, with the latest stop work order, we immediately ceased enrollment. It's worth mentioning, though, that the Independent Data Safety Monitoring Board, or DSMB, for this trial, tasked with assessing the safety of the trial had determined at its meeting in mid- July that the study could continue to proceed without modification, providing further evidence of the safety profile of our vaccine candidate. As a reminder, this Phase IIb trial is a double-blind, multicenter, randomized comparator-controlled study. It's designed to evaluate the relative efficacy, safety and immunogenicity of our oral COVID-19 vaccine candidate compared to an approved mRNA COVID-19 vaccine in adults who have been previously vaccinated against COVID-19. Based on the stop work order notification, we will continue to conduct a 12-month follow-up for all participants who have already been dosed in the trial, which will be funded by BARDA. As we determine next steps for the trial with approximately 5,000 participants enrolled, we believe we will still produce a very comprehensive data readout that is anticipated in 2026. We're also continuing per protocol follow-up work for the 400-person sentinel cohort, which BARDA will continue to fund. Participants are being monitored for up to 12 months post vaccination to assess safety, immunogenicity and efficacy for the sentinel cohort. We expect to report data in the first quarter of 2026. During the second quarter, we reported positive top line results from the Phase I trial comparing our first and second-generation norovirus vaccine constructs. These data showed that our second-generation constructs stimulated higher levels of norovirus blocking antibodies than the first-generation constructs at both the high and low doses evaluated in the trial. The difference was statistically significant in the high-dose cohort. As we've previously shared, these norovirus blocking antibodies correlated with protection against norovirus infection in a Phase II challenge study of the first-generation constructs, which demonstrated a 30% relative reduction in the risk of infection. We believe that the blocking antibodies raised by the second-generation constructs will also be protective against infection. Given that the Phase I head-to-head trial showed higher levels of norovirus blocking antibody with the second-generation constructs, we are optimistic that this will translate into a greater reduction in infection in a field study. We believe that the potential of our second- generation constructs combined with the significant public health need and market opportunity for a safe and effective norovirus vaccine provides us with a meaningful opportunity to attract additional funding that will allow this program to move forward. With a potential partnership or other funding, this program could advance to a Phase IIb study in the second half of 2025, enabling an end of Phase II meeting with the FDA that could support Phase III trial initiation as early as 2026. I'll now hand the call over to Dr. Sean Tucker for the latest developments from our avian flu preclinical program. Sean?

Thank you, James. As many of you are aware, the H5N1 strain of the avian influenza is circulating in wild birds around the globe and causing outbreaks in poultry and dairy cows in the United States. According to the U.S. Centers for Disease Control and Prevention, 70 cases of human H5N1 infection have been reported since the outbreak began, resulting in 1 death. This is not just a U.S. virus with reported cases in Southeast Asia and other places. According to the World Health Organization, there were 15 laboratory confirmed cases of human infection with avian flu in Cambodia this year. While there is no known evidence of person-to-person infection at this time, the continued circulation of the virus increases the risk of mutations that could make animal to human transmission easier or result in human-to-human transmission. Additionally, individuals currently working with Gary Herds at poultry farms or have contact with potentially infected animals could benefit from a safe and effective avian flu vaccine. A key benefit of our vast vaccine platform development is that it allows us to move quickly in formulating and evaluating novel vaccine constructs. Given the potentially growing threat of avian flu, we were able to develop and commence preclinical evaluation of a new avian flu construct in just a few months. Subsequently, we performed a challenge study of this construct where it demonstrated 100% survival and reduced viral load. In this study, ferrets were vaccinated twice with an old H5 vaccine, a new H5 vaccine or placebo. Eight weeks after the first vaccination, they were challenged intranasally with H5N1. 100% of the ferrets receiving the new H5 vaccine survived, while all the animals received placebo died by day 6 post challenge. Three of 8 animals receiving the old vaccine were still alive after 9 days after challenge. In addition to the survival benefit observed with the new vaccine, the study showed a greater than 2 log reduction in nasal wash viral load in ferrets receiving a new vaccine. And this decrease was statistically significant compared with the old vaccine and placebo. We believe these data are highly compelling and have the potential to support a partnership or business development opportunity. We intend to report the data from these and other studies of our avian flu vaccine candidate in a peer-reviewed journal or peer-reviewed medical or scientific conference. I'll now hand the call over to Jeroen for a brief discussion of our financials. Jeroen?

Thank you, Sean. The details of our second quarter 2025 financial results are summarized in today's press release. Revenue for the second quarter of 2025 was $39.7 million compared to $6.4 million for the second quarter of 2024. Revenue in the second quarter of 2025 was primarily from the BARDA contract awarded in June 2024. Revenue in the second quarter of 2024 was primarily from a separate BARDA contract awarded in January 2024. Vaxart ended the second quarter with cash, cash equivalents and investments of $26.3 million. Based on our current plan, Vaxart expects cash runway into the first quarter of 2026. To further extend our cash runway, Vaxart will remain aggressive in seeking strategic partnerships and pursuing other nondilutive funding options. In addition, following an approximately 10% reduction in workforce during the first quarter of 2025, the company implemented an additional reduction in workforce during the second quarter, reducing its workforce by a further approximately 21% to decrease operating costs and better align its workforce with the needs of its business. I will now turn the call back to Steve for closing remarks.

Thank you, Jeroen. I'd like to use this time to provide an update on our stock listing before taking your questions. As many of our listeners are aware, our listing on NASDAQ has been suspended because we are not in compliance with NASDAQ's $1 minimum bid price requirement. Since July 8, our common shares have been trading on the OTCQX best market. While this exchange is the highest tier of the OTC Markets Group, our goal is to regain compliance on NASDAQ, so that we can resume trading on that exchange. While we continue to consider all options in an effort to have NASDAQ lift its suspension of our common shares and appreciate the continued support from our stockholders. We continue to believe that listing on NASDAQ is the best option for the future of Vaxart. We have a meeting with the NASDAQ Hearings Panel tomorrow to discuss our plan to regain compliance, which based on our current share price is to effect a reverse stock split. We will share an update once a decision has been communicated to us. However, there is no assurance that NASDAQ will support our plan. To that end, we have scheduled a special meeting of stockholders to be held virtually on September 5 at 8:30 a.m. Pacific Time and urge a vote for our reverse stock split proposal. A similar proposal was not approved during our annual meeting in June as many of our stockholders at that time believe that were Vaxart traded on the OTC that our share price would grow organically for a smoother path to listing on NASDAQ. As we previously stated, we do not believe our current stock price reflects anywhere close to where we believe is the full value of our company. However, since our listing on OTC, our share price has not appreciated in a meaningful manner, trading between $0.26 and $0.47. We are less attractive to institutional investors and passively managed index funds who often have mandates against investing in OTC-listed companies. And following BARDA's stop work order notification, relisting on NASDAQ is now more important than ever. NASDAQ-listed companies are often viewed more favorably for potential partnerships, making this a critical step for future collaborations. It is for these reasons that we strongly believe that voting for the proposal is in the best interest of Vaxart and for you, our stockholders. In an effort to proactively address questions regarding this proposal and other frequently asked stockholder questions, we will host a live fireside chat on August 20, 2025, at 4:30 p.m. Eastern Time. We encourage you to either send questions in advance to [email protected] or live through the webcast player. We will do our best to answer as many questions as possible with the hope that we can secure your vote. As a reminder, in the event that we receive stockholder approval before proceeding to effect a reverse split, we will first evaluate our situation to determine the likelihood of regaining compliance with NASDAQ. While we work towards regaining compliance on NASDAQ, our clinical, regulatory and operational teams are executing at a high level that has enabled us to report positive data and hit key milestones within our stated time lines. Our Phase I norovirus data, progress with our COVID-19 Phase IIb trial and compelling preclinical data all served as added validation and interest for our revolutionary oral pill vaccine candidates. We look forward to sharing our continued progress. Thanks, everyone, for your time today. We will now take your questions. Since we have our scheduled fireside chat upcoming, we kindly request reserving all questions relating to our proxy for the fireside chat. Operator, you may open the line for questions.

[Operator Instructions] And our first question comes from the line of Liang Cheng with Jefferies.

This is Liang Cheng on for Roger. So congrats on the fast pace of the COVID trial enrollment. So I guess my question about the COVID trial. Now you have 5,000 enrolled plus 400 sentinel cohort that continue the follow-up. So let's just assume that you continue to follow-up those already enrolled patients as planned in the protocol. So what would be your statistical assumption and plan there regarding comparing the immunogenicity and efficacy versus compared to arm? And also maybe just quickly confirm the current enrollment about 5,000 is about 1:1 ratio between these 2 arms.

Liang, thanks for the question. This is Steve. Yes. So first of all, before I turn it over to James, we're really pleased with the rapid enrollment since we got this trial started in April. So getting to 5,000 certainly was not a small feat. And obviously, thanks to the participants as well as our clinical study sites. Your questions on the stats and the ratio, let me turn that over to James.

Thanks, Steve, and thanks, Liang. So it's a 5,000 or about a 5,000-person enrolled study so far. And that's likely to provide some very useful data from both the scientific and regulatory standpoint. The statistical analysis plan, we're relooking at that right now to ensure the best possible use of these data. And to confirm, this was listed as a randomized study. So about half of the folks will receive our test construct and the other half will receive a comparator mRNA.

Got it. And then maybe a follow-up on that question. So alternatively, say if your enrollment resume towards the 10,000 goal. So what's your expectation on the impact for the enrollment pace for the second stop order?

I guess that depends, Liang. It depends on when any changes might occur. What I can say in terms of where we would be in terms of enrollment. So we're waiting more information. When we have that clarity, we'll certainly follow up.

The next question comes from the line of Cheng Li with Oppenheimer.

Maybe just the first question on the norovirus program and congrats again on the pretty impressive data shared in June. I'm just wondering, I think you mentioned the progression to the Phase IIb trial is contingent on partnership or additional funding. So I just want to confirm that you need to secure funding or partnership before you start the Phase IIb study? And also maybe just like a related question, what is the realistic earliest starting time for the Phase IIb study? And then I have a follow-up.

Cheng, thanks for the question. Yes, I'll turn that over to Jeroen in terms of your question. But yes, from our standpoint, I'll just say that since we released the data in June, we've had some productive conversations with potential partners and Jeroen can speak to just the funding.

Yes. As to the funding, we've communicated previously as well that the progression of this study is contingent on funding, whether that's from a partnership or from external funding sources, it is will be contingent.

Got it. And are there any potential gating factor like besides the funding or?

Yes, Cheng, not that we're aware of. I mean, it really is a funding. I mean you obviously are aware of the data, which we were really happy to do. We've really started even the process of lining up what to do next in terms of CROs, et cetera. So it really is primarily a funding gate.

Got it. And just like maybe a question on the COVID-19 program. Can you just maybe share some detail on the rationale behind the second stop work order and whether you think there's a path to resuming enrollment for the program?

Sure. Yes, stated in our opening comments, we haven't received any specific information as to the rationale. What we did was, of course, honored the work order. And so we did not enroll any more participants into the trial. We're very happy that we are around 5,000. And frankly, I think we're just waiting for more additional information from BARDA. We have been in dialogue with them, but we haven't received the specific rationale as of yet.

And the next question comes from the line of Mayank Mamtani with B. Riley Securities.

Now that you've had some time to digest the norovirus Phase I data, including maybe getting some strategic feedback at BIO, like you mentioned. Is there a particular deal structure, economic model that seems most appealing and likely feasible? And has there been any input you've had on the development plan, including the potential correlates of protection that you're pursuing? And then I have a quick follow-up.

Great. Mayank, thanks for the question. I'll let James or Sean answer the second question. But in terms of the first one, we've been pretty clear that we're agnostic. I think it's important from the science and from the clinical development that we want to move forward with the Phase II. So we don't put any strict requirements that it has to be structured this way, et cetera. And we're certainly open to co-development, licensing, important just to get the science moving forward. So we've been very open-minded about that. And I'm sorry, Mayank, if you can ask the second question again, just for Sean and James?

Yes. Just any input on the development plan you have in mind and including the potential correlates of protection that you have in mind based on prior regulatory feedback. Any insight on that?

Yes. Sean, you can go ahead.

Yes. I think the key thing is, obviously, from the challenge study, we know what the most important correlates are. Those are the things we want to monitor from the standpoint of showing immunogenicity is good and would be predictive of success. But the key thing from the standpoint of that Phase II trial is to get enough numbers for safety to allow us to proceed to an end of Phase II meeting with the FDA.

Okay. And also on the avian flu data, is there a publication planned? And what might be the process of securing maybe a federal funding process there? And lastly, Jeroen, on the R&D spend on a go-forward basis, how should we think about that? And should we assume the spend profile that you have will essentially be in some way reimbursed and it's not going to get impacted by the stop work order?

Yes. Mayank, I think the key thing from the standpoint of the publication is to get the paper written. And obviously, the data has come out just recently. So we have a little work to do. In terms of the type of funding, I mean, again, this is avian flu. There's a lot of need. There's a lot of circulating virus in cattle and poultry. And we think that there's a good opportunity to sort of go after people that may be exposed to this. So that would be our next bet.

And as to the R&D expenses, say, per stop work order, it's our understanding that BARDA will continue to fund the per protocol sort of follow-up on both safety and efficacy for the about 5,000 participants dosed to date. And since the cost of running a clinical trial includes substantial fixed cost components, we do anticipate greater than 50% of the original contract to be collected.

There are no more questions at this time. And I would now like to turn the call back over to Ed Berg, who will address written questions from investors.

Thank you, operator, and thank you for submitting your questions. We have a couple of questions on the COVID-19 program. The first is for James. Will a 5,000-person Phase IIb clinical trial, assuming essentially that the stop work order stays in place. Will that produce useful data in support of the product's development plan?

Thanks, Ed. So yes, an about 5,000-person Phase IIb study, it's very likely to provide some very useful data from both a scientific and a regulatory standpoint. Again, we are relooking at the statistical analysis plan just to ensure that we're making the best possible use of these data to support the product development.

Another question on COVID. Do you believe the stop work order could work in your favor and accelerate your time line? James, do you have a sense of the time line?

Sure. So if we are unable to enroll additional patients, subjects due to the stop work order. We do have a time line to report top line data a little earlier than expected. As a reminder, for this study, we required a 12-month follow-up post vaccination period from the last person dosed to assess safety, immunogenicity and efficacy.

Great. And the final question for you, James, on COVID. In spite of lower uptake from the approved mRNA vaccines, why do you think the trial was so successful in achieving a rapid enrollment pace?

Well, there was certainly a robust demand for participating in our COVID clinical study. And I want to acknowledge and thank all the participants and all the study sites and really everyone who worked to rapidly enroll about 5,000 participants. I believe the robust enrollment pace showcases the demand for a better COVID vaccine. While SARS-CoV-2 virus continues to mutate and remains prevalent around the world, we're looking forward to analyzing the data, which may be available as early as late 2026 to the study participants that have already been dosed.

Now we have some questions on norovirus. James, I'm going to call on you again. Were there any surprises in the top line Phase I norovirus data from June?

They sure were statistical significance, right? Although the study wasn't powered to determine superiority by statistical methods, the increase in the MBAA titers with the second-generation constructs were sufficiently large, 141% for the G11 construct and 94% for the G24 construct. This demonstrates statistical significance at the higher dose, which is why we pivoted over to the new construct high dose.

On the noro front, I'll give you a break for a second, James. We'll go to Steve. How close is the company to a partnership for noro? And I know you talked about structure, but where are we on timing?

Yes. Thanks for the question. As I stated earlier, we had some really good one-on-one meetings at BIO back in June. And since then, we continue our conversations with these potential partners. Because these are confidential discussions, it's hard for us to comment on timing. But certainly, when we get to a point of an announcement, we'll put that out there. But I want to just say that we remain in conversations with folks, and they seem to certainly be productive. And a lot of times, it's wanting to see some of the data behind the trial, et cetera.

A question for Sean. The breast milk study showed promising results. Have there been any discussions about another trial to further the understanding of whether there can be passive immune transfer?

Yes. Obviously, we got some great results from the study and continue to evaluate our next steps. As soon as we have a decision, we will make an announcement. However, much of this is funding dependent and underscores just how important it is for us to be able to access funding from a wide range of sources. The next study is likely to be funded by nondilutive funding sources or a partnership.

Great. Another question for you, Sean. This one is whole inactivated virus vaccines have been mentioned in the news. And how does Vaxart's results and Vaxart's construct compared to whole inactivated virus vaccines?

Well, whole inactivated viruses to SARS-CoV-2 have not done so well in clinical studies compared to mRNA. We haven't directly compared against these. But if we do as well or better as the mRNA in the BARDA-supported study, we would expect to do better than whole inactivated viruses as well.

One more question. This could be Steve or Jeroen. With cash runway into 2026, what capital raising strategies are you exploring?

Yes. We've actively engaged in discussions, as Steve has mentioned, with several prospective partners regarding our vaccine platform and programs, including clearly COVID, norovirus and flu. Prospective partners include both regional and global pharma companies. At the same time, I also want to emphasize that we maintain a highly disciplined approach to managing our expenses and ensuring that optimal resource allocation in order to extend our cash flows.

Yes. I'll just add that we really appreciate all the hard work of our employees. And as Jeroen mentioned in the opening comments, right, we had to reduce some of our workforce expenses. And so that's always difficult for us. And as Jeroen said, we look at a variety of ways to raise capital, but also control our spend. And I'll certainly say and we'll continue to beat on the drove that we believe that a listing on NASDAQ would definitely strengthen our position in both the partnership discussions and future financings. And again, we do encourage our shareholders to vote for the reverse stock split. We are going to be happy to take questions. The whole entire management team will be there at the fireside chat next week.

Okay. There are no more questions. I will turn it back over to operator. Thank you to close this out.