Vaxart, Inc. Aktie

Greetings, and welcome to the Vaxart Stockholder fireside chat. [Operator Instructions]. As a reminder, this conference is being recorded. I would now like to turn the webcast over to David Carey of Finn Partners.

Joining us from Vaxart are Steve Lo, Chief Executive Officer; Dr. Sean Tucker, Founder and Chief Scientific Officer; Dr. James F. Cummings, Chief Medical Officer; Jeroen Grasman, Chief Financial Officer; and Ed Berg, Senior Vice President and General Counsel.

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, any partnerships with third-parties, timing of any anticipated regulatory approvals or that any such approval will be obtained, the company's future cash runway, ability to raise capital, 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 risk factors described in the Risk Factors section of Vaxart's most recently filed annual report on Form 10-K and 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, David. Good afternoon, everyone, and thank you for joining us. The second quarter and recent weeks marked a pivotal period of execution and progress for Vaxart. In July, we achieved a key milestone in our Phase IIb COVID-19 trial, announcing positive 12-month safety data from our sentinel cohort. These results provided encouraging validation for the safety of our oral pill platform as we prepare to report top line data from the approximately 5,000 participant main cohort in the first half of 2027. We were able to release this data after we finalized a contract modification with our partners at BARDA in June, which also released dedicated funding that will allow us to conduct a much deeper scientific analysis of the trial data.

I want to express my sincere appreciation to our hard-working employees at Vaxart and the trial participants, clinical investigators, and study coordinators across all our sites. The dedication of these participants and the research teams in executing a trial of this scale and advancing our needle-free vaccine makes our progress possible.

From a business development standpoint, we are continuing to seek a partnership for our norovirus program and have seen continued partner interest. We are taking a disciplined approach to these discussions to ensure any next steps reflect the full value of this asset in the best interest of our shareholders. Right now, it is critical for us to focus on completing the Phase IIb COVID-19 trial, which represents our most immediate value driver.

In addition to our clinical momentum, we have taken important actions to enhance our corporate governance and engage openly and constructively with our stockholders, ensuring we remain strongly aligned. Our decision to enter into a cooperation agreement with the shareholder group reflects our commitment as well as our Board's commitment to strong governance, disciplined oversight, and constructive engagement with our shareholders. As part of these governance enhancements, we reorganized Board leadership and appointed new committee chairs with Kevin Finney leading our Nominating and Governance Committee and Dr. Jim Breitmeyer chairing our Compensation Committee. Additionally, we are forming the Stockholder Engagement Committee and the Clinical and Regulatory Affairs Committee. We are also in the search process for an additional independent director to be added to the Board, working closely with the shareholder group as outlined in our collaboration agreement.

We believe these actions significantly strengthen Board oversight and reinforce our commitment to shareholder dialogue. I'll turn the call over to James to walk us through the details of the COVID-19 data readout. James?

Thanks, Steve, and thanks to everyone there for tuning in. As Steve mentioned, in July, we were pleased to report positive 12-month safety data from the 400 participant sentinel cohort of our Phase IIb COVID-19 trial, and that's funded under BARDA's Project NextGen initiative. To help put this in context, a sentinel cohort, it's really a smaller group of participants vaccinated first to evaluate safety before you expand to a much larger study population. This cohort served as our first direct head-to-head test comparing the safety of Vaxart's oral pill vaccine against an approved injectable mRNA vaccine.

In this group, vaccines were targeted against the XBB variant of SARS-CoV-2, the virus that causes COVID-19, with 201 participants receiving our pill and 199 receiving the injectable mRNA vaccine. On safety and tolerability, which were the primary focus of this cohort, the results were very encouraging. There were 0 vaccine-related serious health complications and 0 severe or long-lasting adverse events in either group. When we look at everyday side effects, our pill demonstrated a very favorable profile. The most common side effects reported with our pill vaccine were mild to moderate fatigue, at about 20.9%, headache at 18.9%, and a loss of appetite at about 10%. Fewer than 10% of participants experienced, really, any other side effects.

In contrast, participants who received the mRNA injection experienced higher rates of side effects at the injection site and throughout the body. Over 60% of the mRNA recipients reported injection site pain. 40.2% reported injection site tenderness, 35.2% reported fatigue, 33.2% reported muscle pain, and 28.6% reported headaches. Additionally, 10% to 15% of mRNA participants reported also joint pain, chills, nausea, diarrhea, and arm swelling. These findings align with what we would expect from our technology. Taking a pill eliminates the injection site pain. There's no injection. So local swelling, systemic discomfort, these things are typically associated with needle-based mRNA vaccines, but not a pill vaccine.

Regarding COVID-19 cases in this 400-person study, 33 participants in the oral pill arm and 30 in the mRNA arm experienced symptomatic COVID-19. That means they have the typical symptoms of COVID-19. In each group, 12 participants had asymptomatic cases, which means they tested positive for SARS-CoV-2 virus, the virus that causes COVID-19, even though they didn't have any symptoms. It's important to emphasize that this 400-person sentinel group, this was intentionally designed to understand, really, only the safety profile to get a safety signal rather than to scientifically prove a statistical difference in protection between the 2 vaccines.

Our main study cohort, which consists of about 5,000 participants vaccinated against the KP.2 variant is large enough to distinguish between random events and events related to the type of vaccine administered. This main group is fully sized and powered to provide statistically significant answers on both safety and relative efficacy. Thanks to our June contract modification with BARDA, we are equipped to perform a much deeper dive into our trial data. This includes evaluating mucosal immunity, which measures anti-body protection right where the virus enters the body in the nose and in the mouth, alongside the broader immune and safety measures. We're actively advancing these detailed analytics, though we're not in a position to provide a reporting time line at this time. As I mentioned, it's part of our contract with BARDA. It provides the agency with authority over all the readouts.

As Steve mentioned earlier, we look forward to reporting top line data from the approximately 5,000 participant main cohort in the first half of 2027. I'll now hand the call over to Jeroen for the financial update. Jeroen?

Thank you, James. So Vaxart ended the second quarter of 2026 with $64 million in cash, cash equivalents and short-term investments. Based on our current operating plan, we continue to project that our capital will fund the operations into the second quarter of 2027. Revenue for the second quarter of 2026 was $27.2 million compared to $39.7 million in the second quarter of 2025. This revenue was primarily derived from our BARDA government contract, along with $2.9 million of revenue from our license and collaboration agreement with Dynavax that we signed in November of last year. Our research and development expenses were $33.7 million for the quarter, down from $49.7 million in the prior year. This net decrease is primarily due to a decrease in clinical trial expenses related to Vaxart's COVID-19 vaccine candidate and reduction in personnel costs, facilities costs, as well as pre-clinical manufacturing costs. General and administrative expenses were $6.6 million for the quarter.

Overall, Vaxart reported a net loss of $13.5 million or $0.06 per share compared to a net loss of $15 million or $0.07 per share in the second quarter of 2025. Additionally, our $25 million share purchase agreement with Lincoln Park Capital remains available, giving us flexible access to capital at our sole discretion. We remain focused on disciplined financial management and evaluating non-dilutive funding options such as government grants and non-dilutive partnerships as we work towards our upcoming clinical milestones. I'll now hand the call back to David to take your questions.

Thanks, Jeroen. So we've received many questions from shareholders in advance, and we group those questions by topic. So we'll take the pre-submitted e-mail questions first, and then we'll move to live questions that are coming through the webcast portal.

So the first set of questions are related to COVID-19. And James, could you please take this question? It's when should shareholders expect efficacy on the 5,000 participant study? When should we expect comparative immunogenicity data from the approximately 400 subject COVID study? So 2 questions there. And will data include meaningful comparisons with currently available mRNA vaccines?

Thanks for the question. So we expect to release the top line efficacy and safety data from the complete study set comprising the 400 participants in the sentinel safety cohort, and as I mentioned, the approximately 5,000 participants in the main cohort in the first half of 2027. As far as the immunogenicity data from the 400 or so sentinel cohort, the Phase IIb trial was structured under an award from BARDA. A core mandate of this BARDA-funded trial design is to directly evaluate the relative efficacy, safety, and the immunogenicity of Vaxart's oral pill vaccine against an active approved injectable mRNA vaccine comparator.

We're actively advancing this process. So we aren't right now in a position to provide a specific reporting time line. And this is due in part as our contract with BARDA, as I mentioned, provides the agency with the authority over the time and the content of all the readouts that we release.

Thank you, James. Sean, could you please take the next question? With COVID rapidly mutating and in some circumstances, substantial mutations like from XBB to KP2 to XFG and Takeda, can IgA handle mutations with that much variance?

Yes. Thanks for the question. We know that IgA has a greater ability to handle variants than IgG, and we know our platform does elicit the strong mucosal IgA responses. As everyone knows, we previously reported that our oral COVID-19 vaccine demonstrated broad cross-reactivity with a variety of SARS-CoV-2 variants, but also with other coronaviruses. So we really do have confidence that our approach is going to work out better than an injected vaccine. Of course, ultimately, we will find out a lot more about the performance of our vaccine when we look at the analytical data for both the sentinel and the main cohorts of the COVID study that is currently enrolling and -- actually, finished enrolling and still in progress, there's a large amount of data we're going to get because the study is so large.

Thanks, Sean. Next question, back to James. You know how many total cases of COVID, both symptomatic and asymptomatic, have been seen in the larger 5,000 group so far. I know we don't have the details yet as they are still blinded. But just curious if you know the total with positive COVID infection.

Thanks, Dave. Thanks for the question. So we're still monitoring subjects and are accruing cases in that 5,000-person cohort, as I mentioned. Our plan is to provide that information as part of the release of data on the main cohort in 2027. As a reminder, and again, not to be a broken record, BARDA approval is required before any release of information, and we're aligning with BARDA on each data release.

Okay. Next question for Sean. Back to you, Sean. Dr. Cummings previously stated that for the COVID vaccine that low dose and high dose produce similar IgA. The NextGen construct high dose was not tested in humans. So was that based on the original Phase I trial data from 2020/2021? Or was it based on modeling to estimate the IgA response under different doses? Clearly, for noro, there was a material difference.

Yes. Thanks for your question. Well, earlier trials of our COVID-19 oral vaccine were used to guide dosing. For example, we found that the low dose and the high dose of our oral pill vaccine had a similar immune response when used as a booster in people that have previously received an mRNA vaccine. Obviously, everybody in this study has already received an mRNA vaccine at some point in their past, and we think that was a good guide for dosing.

We'll have better insights in the immune response of the current vaccine once we've analyzed immunological data, and that will help us determine appropriate immune correlates, and again, guide us to whether a higher dose should be explored. I would point out in the question about the norovirus study that, yes, we did see a statistical difference between the old norovirus construct compared to the next-generation norovirus construct when you looked at just the high dose in the Phase I study. Again, this is the study we ran in 2025. And again, that was great. We know that the new constructs are better.

However, the difference between the high and the low dose of the next-generation norovirus construct wasn't statistically different even if there was a slight numerical difference. These difference could be just resulting from randomness in human-to-human variation rather than true dose effect. I should also point out and let -- and remind you that dosing for one vaccine isn't necessarily going to be the same from each disease target, even if the vaccines are built on the exact same platform.

Thanks, Sean. James, back to you. Even though it wasn't powered for efficacy, are you surprised that Vaxart's improved NextGen product produced similar infections of mRNA, where we know it wanes quickly and is more lock and key, as you have stated. What happened to Vaxart's product providing cross-reactive immunity and more durable immunity?

Thanks. So first off, from an efficacy standpoint, our pill vaccine candidate compared very favorably to an approved injectable mRNA comparator, demonstrating similar efficacy in this sentinel cohort. That said, this overall data set is exciting. It's important to emphasize that this 400 participant group was primarily designed to evaluate safety. And it really lacks the statistical power, as I said, that's required to draw definitive conclusions about how efficacy or cross-reactive immunity is present in the study.

Assessing true mucosal protection and long-term durability, the second part of your question, David, requires really a much larger clinical trial population monitored over time. But we're going to gain some greater insight into the duration of response, the broad cross-reactivity, and the relative efficacy or comparative efficacy once we receive and we analyze the complete data readout from the main 5,000 -- approximately 5,000-person participant cohort.

Thank you, James. Here's another question for you. The release of the sentinel cohort data took longer than management initially anticipated. As you look ahead to the full Phase IIb efficacy readout expected in the first half of 2027, are you confident that the processes and agreements with BARDA are now in place to support a timely release of those results?

Thanks for the question. The delay of the sentinel cohort was primarily driven by standard BARDA partnership protocols, which require the initial data package to flow through government review as well as modification of our contract I mentioned a little earlier, to reflect the scope of the trial following the pause and stop work orders. So with these foundational protocols and contract framework fully established, our team is applying those -- really, those key operational learnings directly to the execution of this main study. That said, it's important to reiterate that under the terms of the contract, BARDA has final approval on timing and content of all readouts.

Integrity of our data is critical. Really, it's why it's so important we follow those protocols. But we have an experienced team that's managed this process, and we will continue to do so. The main study of about 5,000 participants is already fully enrolled and actively being advanced. And I look forward to reporting top line data in the first half of 2027. We're all fully focused on achieving this core milestone as fast as we can for such a large and complex study with the highest fidelity data possible.

Thanks, James. Sean, the next question is for you. It appears your oral COVID vaccine may have use as a therapeutic in long COVID. Is this something worth considering? Obviously, a large percentage of the population is affected. Have you ever sat in your car at a turning arrow and missed the turn because of a driver ahead of you has a lack of attention, while working on this as a therapeutic may ease the acceptance requirements.

Yes. Thanks for your question, and it's certainly very interesting to us. Again, we're very bullish about the potential of our COVID vaccine for treatment of long COVID. Obviously, the causes of long COVID continue to be evaluated, but there is evidence that some people experiencing long COVID may have low levels of viral replication and small pockets of replication within their body. It's not clear why the immune system can't clear the infection from the rest of the body by leaving these small pockets, but we do know that there's been some studies out there that said they exist.

We do know these pockets can occur in the intestinal tract. And obviously, our oral intestinal targeting approach could potentially do something to address those small pockets of replication. I also would point out, of course, this is clear that this is obviously just a hypothesis, and we would need to conduct another clinical trial of people with long COVID and determine if our oral pill could eliminate or do some things to improve those people's lives. Ultimately, as I pointed out before, Sanofi holds the final decision whether they [indiscernible] in advance of the clinical trial, specifically to long COVID.

Thanks, Sean. Okay. Let's move on to norovirus. A few questions -- actually, several questions came through. So Steve, can you take this question? With Moderna's norovirus program currently on hold and Vaxart having generated encouraging safety data from approximately 400 participants, have discussions with potential pharmaceutical partners become more active? Without disclosing confidential information, can management provide a sense of the valuation range being discussed for a partnership?

Thanks. I'll go ahead and address the Moderna's norovirus program first. So what we saw in the news was that Moderna needs another season to complete enrollment in their trial. So it's not on hold, but it's been extended, essentially, for another season, which, of course, extends the timing of the trial. From our standpoint, it's a mixed blessing. On one end, we see them as competition. And the sooner we can get our Phase II trial to move forward, the closer we can stay close to them in terms of being in the marketplace. So having them delayed, of course, provides a little bit of a competitive advantage. So that's a positive. The not so positive, which, again, we'll do our best to always mitigate, is that now we have another data point in the norovirus marketplace where there was a company that failed, HilleVax.

There is Moderna, which is extending its time line. So when we're talking to potential partners, they also keep that in mind as well when they're looking at, is this a good opportunity? In terms of the question around the valuation range, we normally don't communicate that primarily because we don't want to negotiate against ourselves. I will say that we, at Vaxart see high value in norovirus, which is why we continue to have discussions with potential partners.

We think this is a huge unmet need. And as a result, we still continue to promote this to other potential partners. And the Moderna data as well as the fact that we do have the positive safety data with the sentinel cohort, I'll say that it's allowed us to reach out to companies that, let's say, haven't responded in quite some time, and it's helped us to at least make them aware of here's the latest data if you haven't been paying attention. So I would say in that regard, it's been helpful.

Okay. Thank you, Steve. The next question is kind of similar. I'll read through the entire question. And I think Sean, if you could answer this and then Steve, if you have any follow-up. The question is management has previously indicated that partnering interest in Vaxart's norovirus program could increase following Moderna's interim analysis of its Phase III norovirus study. Moderna recently announced that its trial did not meet the statistical criteria for early success and that it plans to enroll an additional cohort. Does management view this outcome as favorable or as an obstacle to Vaxart's competitive and partnering position?

Yes. So when I was talking earlier, as I was saying, and certainly the question here is asking, is it a positive or negative? I'll call it next mixed blessing again. From a competitive standpoint, it certainly helps us. From a watchout perspective, if I am a potential partner, they're also looking and asking why it's taking so long for Moderna? And they put that into their thought process when they're talking to us about how to conduct a trial in norovirus. I think Sean has perhaps a scientific or statistical view on that as well if you want to chime in.

Well, again, I'd love to speculate, so I want to tell you a little bit of what I'm thinking. I mean, obviously, we don't have a copy of Moderna's statistical analysis plan. So we don't exactly know why they failed at the interim analysis. But we do know that they are continuing the study. And if so, what is possible and what seems likely to me is that they saw some efficacy, but they didn't meet some pre-specified endpoint.

But I think the continuation of the study is a positive step because they knew -- they see value in this indication, and there's a reason to go forward. As I've said many times before, we believe that intestinal anti-bodies are important for protecting against norovirus, and we know our oral tablets is going to do a better job of listing these than an injected vaccine. So we're really bullish that our vaccine could potentially provide better efficacy than Moderna's vaccine.

Thank you, Sean, Steve. Steve, another question for you. Why has norovirus time line been removed from the corporate slide deck? And why is the program not mentioned in the quarterly business update?

Yes. So on the second part of the question, the reason why it may not have been in the quarterly business update is we have a lot of good data to share on COVID. So we wanted to highlight that because that's the near term, and of course, the agreement with BARDA. So that's the reason why we are focusing more on COVID.

In terms of the norovirus time line, the other thing that we want to be very transparent about is we are continuing to promote this opportunity to potential partners. It is work in progress. And because it's work in progress and the fact that we have not secured funding, and we'll look for non-dilutive funding as well, not just potential partner funding. But on top of that, since we don't have funding, I think it's premature for us to put down when the start is of that Phase II study because it is contingent on funding. So that's the reason why the corporate deck has now been updated.

Okay. Thank you, Steve. Now pivoting on to a couple of questions related to BARDA. James, could you please take this one? What additional analysis is being performed with the $29 million in additional funding from BARDA? And why was it not assumed at the outset of the trial versus adding it in on prior to unblinding? Did Vaxart request the $29 million? Or did BARDA request additional analysis and Vaxart said it would cost $29 million?

Thanks for the question. So the $29 million released through the BARDA contract modification funds final trial execution and expands exploratory safety, immunogenicity, and efficacy analyses, such as deeper subvariant genomic sequencing and extended mucosal and cellular biomarker profiling across the 5,000-plus participant main cohort. Some of the analytical work was originally contemplated as a second phase after the initial data was reported, but we're very pleased that BARDA has agreed to fund that work and allow it to begin even before the final completion of the study.

The modification represents, really, a mutual agreement. BARDA required high-resolution exploratory data to validate whether or not oral mucosal technology offers unique advantages under its Project NextGen mandate. And Vaxart established the operational budget and the $29 million requirement to complete the trial and deliver those comprehensive data sets. I hope that answers your question.

Thanks, James. Sean, next question for you. Management often talks of seeking non-dilutive funding and did an excellent job finding that with the Dynavax partnership. Shareholders often see government-sponsored RFIs and grant applications that would seem to be a strong fit for these Vaxart pipelines. Can you confirm if Vaxart actively participates in these RFIs or if additional government funding is considered unlikely until after the Phase IIb?

Yes. Thanks for the question. Again, Vaxart has a strong proven track record and history of being successful in securing non-dilutive funding. I would say most notably demonstrated by our substantial award under BARDA's Project NextGen, but we've also been able to do projects with the Gates Foundation. We've retained grants with the NIH in the past.

So we've been pretty good about this. I assure you that we've been -- we're aggressive in exploring various strategies to extend our cash runway through business development and non-dilutive funding options and the goal is to achieve upcoming clinical and regulatory milestones and maximizing shareholder value. Keep in mind, though, that we don't comment on what we're pursuing at the moment on dilutive pursuits for competitive reasons, but we do talk about the funding once it is confirmed.

Thanks, Sean. Jeroen, next question is for you. Given Vaxart's stated cash runway into the second quarter of 2027, the planned end of Phase II meeting with the FDA and the terms and decision time line under the Sanofi contract, does management expect an opt-in decision from Sanofi before the company's current cash runway is exhausted? If not, how does management plan to finance operations through the opt-in decision point while minimizing dilution to shareholders?

Great. Thank you, David. So yes, we fully agree fully as a team here on the need to extend runway, both through that Sanofi opt-in that's referenced in this question as well as to sort of fund progress on the promising pipeline programs that we've been talking about, norovirus and flu and HPV as well. First focus, clearly, as CFO, financial discipline is top of mind. So cost efficiency and ensuring all the spending goes towards the corporate priorities and enabling meaningful milestones is our first focus from a financial perspective.

As Steve mentioned, and Sean just now as well, we're exploring all options to secure incremental funding going, I guess, from these non-dilutive funding sources, including the government, including the NGOs like the Gates Foundation, and seeking strategic industry partners for our programs.

The final piece I want to highlight here is that we have also still access to this $25 million share purchase agreement that we secured in the recent quarter here with Lincoln Park Capital. That's $25 million that we can -- we have flexible access to, we can access at any point that we want to on terms that I would call, generally, very favorable compared to a more dilutive larger raise. So back to you, David.

Thanks, Jeroen. Next question is for Sean. Has Dr. Sean Tucker with the scientific team reviewed existing pre-clinical or clinical sample data sets to evaluate whether Vaxart-induced mucosal CD8 T cells naturally express CD39? If Vaxart moves forward into the next clinical phase for HPV is the plan to option A, advance the current formulation into trials while adding CD39 expression as an exploratory biomarker/ endpoint or option B, complete pre-clinical optimization to ensure robust CD39 solicitation prior to finalizing the clinical protocol.

Yes. Thanks for the question, and thanks for talking up the importance of CD39, which I think is a really interesting biomarker. We didn't look at it in early pre-clinical studies, but it's definitely something we are interested to track in future studies.

Thanks, Sean. Next question is also for you. Given Moderna's recent FDA approval for mRESVIA, what is Vaxart's take on the approval? And how does this influence your flu vaccine program?

Yes. I mean it's exciting. First, we'd like to say this represents an important step forward for the vaccine industry, having more options for public health is important from our standpoint. Moderna has really proven that the market is ready for new approaches rather than just legacy flu shots. Some vaccines development may improve efficacy, convenience or both. And again, from our standpoint, as we advance our oral flu vaccine candidate through clinical development, we think we're uniquely positioned to deliver what we think is the ultimate end state for respiratory immunization, needle-free, room temperature stable, mucosal protection in a simple pill.

Thanks, Sean. Steve, the next question is for you. With Dr. Breitmeyer joining the Board having an incredible background in oncology, should we expect to see an acceleration of Vaxart's HBV program in the coming months?

We're really thankful that Dr. Breitmeyer joined our Board. He's a great match for us with his extensive experience in vaccines and oncology, to name a few other therapeutic areas. And as part of our game plan with the Board, as I said earlier, we have formed a clinical and regulatory affairs committee. And so that will be part of the work of that committee in terms of looking at our whole entire portfolio suggestions on where to accelerate, what's high value. And so there's a lot of inputs that go into that. And certainly, with Dr. Breitmeyer on board, we'll be doing that.

And as well, this was also part of the settlement with the cooperation agreement with the stockholder group to form this Clinical and Regulatory Affairs Committee. I also want to just take a moment and acknowledge and thank the stockholder group. We've had dialogue and we've been interacting as a group, and they've been helpful in terms of talking about next steps with how we engage stockholders. So again, just thank you for working with us on that settlement.

Steve, another question for you. Can Vaxart discuss the projected time line in terms of advancing the norovirus program, if a suitable partnership cannot be established and provide some additional color on the company's plan.

Sure. So what we are really looking at because as Jeroen was talking about our cash runway, it is important for us to have a partner who can fund this project to the next phase. And that is why we are spending a lot of time promoting this asset as an opportunity for partnership. If we run into some challenges around that, I'll say concurrently, we have been also talking to other funding sources, non-dilutive funding sources even governments outside the United States, just to give everyone an example.

So our game plan is to continue to promote this. I will also say that you may not have as many frequent updates regarding this. And if we decide ever not to pursue this, we'll, of course, share that publicly as well. But there are a lot of questions that do come up in a lot of these partnership discussions, and they include the market size. We may have differences in viewpoints on market size. A lot of these potential partners were also waiting for what was happening with Moderna. So I think that's also being processed in their analysis. But that just gives you an idea of what we're looking at as it relates to the norovirus asset.

Steve, another question for you. As a CEO of a public company, what would you like to tell your long-term investors who have funded this company at times of distress and kept the lights on?

Well, first and foremost, we do want to keep the lights on because as -- Sean is sitting next to me right here, nodding, we really believe in the science. We want to take this as far as we can and the great ideas that Sean had has as the founder of this company, we're committed to moving that forward. So I would tell the investors, stick with us. I mean we really believe in what we're doing. We're not going to give up. Oftentimes, we do have to make tough choices. And those tough choices include what we unfortunately had to do last year, which we had to reduce costs, and we had to lay off a few employees. And at the same time, we also have to keep the current employees motivated.

But from an investor standpoint, I'll say I'm in full agreement with everybody that we believe this asset -- these assets are undervalued. We want the stock price to go up. We're going to keep fighting, and we're going to work as hard as we can to ensure that. Our vision is the fact that as we talk to many investors sometimes, we highlight the fact that if they had a choice on whether to take an injection for a vaccine or take a pill, I mean, the investors certainly personally would do the same thing. So we are going to keep doing what we're doing. I really want to acknowledge and thank the investors for sticking with us, for being active, for asking good questions and really appreciate your constant engagement.

Thanks, Steve. And actually, Steve, I will turn it back to you for any closing remarks.

Great. Well, let me say once again, just thanks, everyone, for joining us today, submitting your questions, asking the tough questions as well. This quarter marked significant progress for Vaxart with encouraging head-to-head safety data from our Phase II COVID-19 sentinel cohort, government funding for expanded analytics and a clear path forward towards full study results, we believe we're well-positioned to demonstrate the true value of our oral pill vaccine platform. Every milestone we reach is rooted in our commitment to patients, trial participants, and public health worldwide.

As we observe National Immunization Awareness Month this August, we are reminded that traditional vaccines still leave far too many barriers in place. Vaxart has driven the change now. We remain dedicated to delivering convenient, needle-free,, oral pill vaccines that make vaccination easier, broaden global access, and protect communities everywhere while generating sustainable long-term value for our stockholders. I want to close by thanking our stockholders for engaging in constructive dialogue with us as well as our talented Vaxart team for their continued hard work and passion. Thank you all for your time, and have a great evening.

Greetings, and welcome to the Vaxart Stockholder Fireside Chat Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the webcast over to David Carey of Finn Partners.

Thank you, operator. Good afternoon, and welcome to today's call. Joining us from Vaxart are Steve Lo, Chief Executive Officer; Dr. Sean Tucker, Founder and Chief Scientific Officer; Dr. James Cummings, Chief Medical Officer; Jeroen Grasman, Chief Financial Officer; and Ed Berg, Senior Vice President and General Counsel.

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, any partnerships with third parties, timing of any anticipated regulatory approvals or that any such approvals will be obtained the company's future cash runway, ability to regain compliance with NASDAQ listing standards or raised capital of such listing is regained and its product development and regulatory process, 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 in other public 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, David. Good afternoon, everyone, and thank you for joining us. In the first quarter, we made meaningful progress advancing our clinical programs and preparing for key data milestones that we believe will help demonstrate the value of our oral vaccine platform. Beyond preparing our COVID-19 program for its upcoming readout and have also spent the last few months strengthening our financial position and streamlining our operations to support disciplined execution and extend our runway. Specifically, our work during the first quarter was focused on the steps needed to disclose data from the 400-person sentinel cohort of our Phase IIb COVID-19 trial. This cohort is an important part of our program, providing our first 12-month look at the safety, select efficacy measures and the also immune response of our oral vaccine candidate in a head-to-head study. We are currently working through the data reconciliation process required to complete the analysis and move toward a top line readout. This effort is backed by a strong commitment from our partners at BARDA.

To further strengthen our Board and add clinical and strategic oversight, we were pleased to welcome Dr. James Breitmeyer to our Board of Directors in April. Jim is a veteran of drug development, who has successfully led multiple candidates through complex clinical and regulatory pathways. He brings more than 35 years of biopharmaceutical experience, including leadership of programs resulting in multiple FDA approvals and global regulatory successes. As part of our ongoing commitment to Board refreshment, with the addition of Dr. Breitmeyer, we have added two new directors with significant drug and business development expertise over the past two years to strengthen the addition of fresh perspectives. We believe that adding directors with these proven track records is a significant advantage as we approach our upcoming data catalysts.

On the operational side, we completed our headquarters move in April, consolidating and reducing our footprint and also established a $25 million share purchase agreement with Lincoln Park Capital. No shares have been sold to date and the use of this purchase agreement is subject to the company's discretion. These steps are part of our ongoing effort to maintain a lean operation, provide financial flexibility and position us to direct our capital towards our core drug development programs. Finally, we continue to maintain a productive dialogue with the team at Sanofi as we advance our COVID-19 program.

I'll turn the call over to James now to update you on where we stand with the COVID-19 trial. James?

Thanks, Steve. The primary goal of our Phase IIb COVID-19 trial is to evaluate the safety and the efficacy of our oral vaccine pill against the leading injectable mRNA vaccines. This is the first time our mucosal technology has been clinically tested in a head-to-head comparison against an approved mRNA standard, which is a significant milestone for our platform. This first look at this head-to-head evaluation comes from our 400-person sentinel cohort. We are currently in the final administrative stage of data validation and quality reconciliation for this group.

I want to be very direct on our current status. Vaxart management is currently blinded to the results and has not reviewed the data. This is a standard procedure to ensure that the analyses are finalized before the results are unblinded and shared in accordance with our agreed-upon process with BARDA, our funder. Because this is a BARDA-funded study, there are established partnership protocols and data sharing processes that govern the process of our unblinding. These are deliberate and their standard administrative steps required when working with a government partner. We are currently completing those final steps in coordination with BARDA to support the release of top line results. As a reminder, the primary purpose of this sentinel cohort is to evaluate the safety and the inogenicity, including longer-term follow-up.

While there will be some efficacy related measures reported this 400-person sentinel cohort was not powered to provide statistically significant comparison between the oral pill and mRNA vaccine groups. As we announced in January of 2025, an independent Data Safety Monitoring Board, or DSMB, has already conducted a planned review of the initial safety data from this cohort and recommended the study continue without any modifications. This provided an important external validation of our platform safety, while we, at Vaxart, remain blinded to the full 12-month data. While these results are an important precursor to how our oral pill vaccine performs against mRNA vaccines, as we mentioned, this cohort was not powered to provide definitive efficacy comparison. More definitive insights are expected to come from our main cohort of approximately 5,000 participants, which is designed and powered to evaluate relative efficacy and safety.

I'll now turn the call over to Sean Tucker to discuss norovirus. Sean?

Thank you, James. We are currently evaluating how our second generation constructs perform against the GII.17 norovirus strength. GII.17 has become a much more prevalent strain, and we are testing our bivalent vaccines cross-neutralization capabilities to ensure it can recognize and neutralize this emerging variants. We expect to share that preclinical data and add thought clinical evaluations in the last study later this year in both scientific meetings and potentially scientific publications.

Regarding the next steps for norovirus, we are prepared to initiate our next clinical trial in 2026, depending on the ownership or the receipt of other funding. In the meantime, we are continuing to refine our vast platform and our manufacturing processes in order to ensure our high-yield tableting is ready for large-scale needs.

I'll now hand the call over to Jeroen for the financials. Jeroen?

Thank you, Sean. Vaxart ended the first quarter with cash, cash equivalents and short-term investments of $61 million. Revenue for the first quarter was $39.2 million compared to $20.9 million last year, with the growth in revenue, primarily driven by BARDA contract. First quarter 2026 also included revenue recognized from the Dynavax license and collaboration agreement signed in November 2025. We also reduced our R&D and G&A expenses compared to the first quarter of 2025 by closely managing personnel and facilities costs. The revenue growth and cost control measures led to a net income of $5.2 million for the quarter or $0.02 per share. As Steve mentioned, we enhanced our financial flexibility in April by establishing a $25 million share purchase agreement with Lincoln Park Capital. This facility provides us with an efficient capital management tool that we can utilize to support our capital needs at our discretion over the next 24 months.

Based on our current plan, we continue to expect our cash runway to extend into the second quarter of 2027. With that quarter's move completed and the lease termination taking effect next week, we have significantly reduced our long-term liabilities and fixed overhead, allowing us to focus our resources on our clinical catalysts.

We'll now take your questions.

So we've received numerous questions from many shareholders. And there were several overlaps. So we're grouping the questions initially together by topic. So the first question is we've been getting a lot of questions on the primary focus of the sentinel readout, and if it is safety and not efficacy. And in addition, the questions regarding whether people can expect the readout given that early Q2 has already passed. And I'll turn that question to James. James?

Sorry, I was stuck on mute. Thanks, David. As a reminder that the primary purpose of this sentinel cohort is to evaluate safety and immunogenicity, including longer-term follow-up. It is not, and it's never been the purpose to evaluate efficacy. While there will be some efficacy related measures reported, this 400-person sentinel cohort was empowered to provide. This is the important part, a statistically significant comparison between the oral pill and mRNA vaccine groups. As we announced in January 25, an independent data safety monitoring board already conducted a planned review of the initial safety data from this cohort, and it recommended the study continue without any modifications. The DSMB has continued to meet and reaffirm these findings. This provides important external validation of our platform safety while we remain blinded to the full 12-month data. While these results are an important precursor to know how our oral pill vaccine performs against mRNA vaccines, as I mentioned, this cohort was not powered to provide a definitive efficacy comparison, this smaller cohort. That's because it's a 400-person cohort and would not be specifically powered to reach that conclusion. This ensures enough data is collected to avoid false negatives and showing results are not due to chance. But more definitive insights are expected to come from our main cohort of the approximately 5,000 participants in this study, and it's designed and powered to evaluate relative efficacy and safety. In addition, we're dedicating significant resources to manage the 5,000 participant main study cohort, which is a primary focus of our clinical efforts. We anticipate the primary efficacy and safety data readout from this larger group in early 2027. I think that sums it, David.

Okay. Thank you, James. Next question is also for you. Does Vaxart believe there will be a meaningful difference in immunogenicity, longevity and cross-reactivity of immune response, and viral -- sorry, better load reduction that would be visible even in a small cohort?

Thanks, David. I'm not going to jump to any conclusions or predetermine any outcomes here. We're blinded to the data. Once we're unblinded, we will evaluate it for appropriate context.

Thanks, James. Another question for you. What specifically still needs to be done by Vaxart and BARDA in order to release the sentinel cohort data?

As I mentioned earlier, we're currently in the final administrative stage of data validation and quality reconciliation from this group. And that's pretty standard. As part of this process, the data is being carefully reviewed to ensure accuracy, completeness, consistency prior to analysis, again, typical for a study of this size and importance. This means that a third party is evaluating the database to ensure that data has been entered correctly and to identify any records that might be and complete. This is done to ensure that the final analysis is done on the most accurate data possible. We're working closely with our partners at BARDA to complete these steps in order to release the sentinel cohort data. To be clear though, this is a procedural matter. It is not a data issue. The study remains blinded, and we have not yet seen the results ourselves.

Thanks, James. Next question we've received from several individuals and also on the online portal here this afternoon. Why has the time line slipped? Are you confident that the data will be released before the end of the quarter?

That's a fair question. The third-party review is taking a little longer than anticipated because there are some very specific partnership protocols and some contractual data sharing guidelines that covering the timing of our unwinding. These are deliberate administrative steps required when you work with a contractual partner. All of this is taking really a lot more time than we'd hoped. We are working through those final steps now. While we are still aiming to release the top line results in Q2, it's important to remember that we are working with the contractual part of a partner, and we're not in full control of that timing. That's my projection.

Okay. James, can you provide additional details as to what BARDA is requesting from Vaxart that's causing the delay in disclosing your safety data?

Sure. So as part of our collaboration, BARDA is working with us to finalize the analysis plan and ensure all relevant data elements are incorporated for the sentinel cohort being something I mentioned previously. This includes reviewing certain information that's typically addressed later in the study, but it's being incorporated at this stage to support a thorough and aligned analysis process. We continue to work closely together to complete these steps and ensure the data are fully validated and ready for disclosure.

Thanks, James. Next question. Does the delay in reporting the results from the sentinel cohort indicate that there is a problem with the data or the process for collecting or analyzing it.

Starting to sound like the James show. And no, it does not. This is a part is regular process for data analysis and sharing it is not related to the data, the collection process or the analysis. Our government partner had specific protocols governing when and how blinded data can be unblinded and share. Those steps have taken longer than we originally anticipated, but they are procedural in nature. Vaxart Management is currently blinded to the results, and we have not seen the data. Once we get the administrative clearance, we will flip the card over, unblind and report me. We're excited to do so as you are.

Okay. Thank you, James. Let's switch to norovirus. Next question is, have there been any further conversations with your prospective partners about the norovirus program. Do you believe there is a realistic chance of securing a funding partner before the end of the year for norovirus. And Steve, I'll turn that to you.

Yes. We continue to have active discussions with potential partners. And I want to just tell everybody, this remains a priority for us. As you would expect, however, we can't guarantee that there will be an agreement and when they occur, but I want to assure everybody that we're working continuously to make sure that we keep having good active discussions. This is with great focus and conviction on our team. And frankly, securing funding for this trial is a critical next step for the company, and we're certainly treating it that way.

Okay. Steve. Next question is, what is the likelihood that a Phase IIb norovirus trial begins in Q3? And Steve, could you take that one?

Yes. We understand this question is about pace. And let me take a few moments to explain how we approach this, right? So the gating factor is funding. It's not science. We have noted that, and you've probably seen that advancing the norovirus program is important to us for the next clinical stage, and that really is dependent on securing a partnership or some external funding. We are, like I said earlier, engaging with potential partners. We're looking at various options, and we do want to move this forward in a very strategic and capital-efficient manner. Funding this does require significant resources, so it's important that we align this program with the right partner, with the right funding structure to support its success. Because we want to be good stewards of shareholder capital. We're not going to rush into a trial that's going to be underpowered or under designed just to hit a certain milestone.

Thanks, Steve. Next question. And Sean, could you please take this one? Has BARDA shown any interest in norovirus or flu. It would seem with their goal of next-gen platforms that Vaxart is uniquely positioned to work with them, to bring those products coming to market.

Sure. Obviously, we have an ongoing productive relationship with BARDA through our COVID-19 program. And of course, we had a past relationship slip relationship with them on flu. So they are really familiar with our platform and our broader capabilities. At this time, BARDA support is focused on the current COVID study, and we have not announced the additional funding from BARDA for the norovirus or flu programs. We will continue to evaluate a range of potential funding sources, including government and strategic partners to advance all of our programs.

Thanks, Sean. Do you believe you'll be able to elicit VX20 and/or VX22 antibodies in a majority of subjects before you begin the NORA Phase II. Sean, could you take that one?

Yes, it's an interesting question. VX20, VX-22 are monoclonal antibodies with broadly neutralizing capabilities and a cross-reactive against many different genotypes. Keep in mind, these antibodies were clone from a Vaxart clinical trial participants However, these clones may not be relevant for all people with various generic genetic backgrounds. Because of this, we are focused on efforts to advance our norovirus programs that can address all people and all genetic backgrounds. The key thing from this is that we are currently doing things that are much more proactive and relevant such as testing our bivalent vaccine cross neutralizing capabilities against the GII.17 norovirus strain, which has recently become a more prevalent variant across the globe.

Thanks, Sean. Next question. Can you give us an update on your interactions with Sanofi. Are you confident that Sanofi will continue the partnership that you establish with Dynavax. Steve, could you take that, please?

Sure. So as a reminder, Dynavax became a subsidiary of Sanofi, and that closed in the first quarter. So moving forward, I'll generally refer to this collaboration at Sanofi. And so I'll certainly let you all know that we continue to have a -- and maintain a very good productive dialogue with the team at Sanofi as we advance the COVID-19 program forward. They share in our view that the global demand for COVID-19 vaccines remains robust. And as a reminder to everybody, our exclusive license and collaboration agreement with Sanofi is a worldwide agreement. [ Sanofi ] has the option to assume full responsibility for the program only after evaluating the results from the Phase IIb clinical trial and at the end of Phase IIb meeting with the FDA. Because this ongoing trial is heavily funded by BARDA, as we've discussed in the past, our partners at Sanofi certainly see this is gaining access to a high-value clinical data trial that has been significantly derisked by government investment.

Thanks, Steve. Next question, has there been any update on the status of the avian influenza study or when investors might expect to see the results? Sean, could you please take that?

Yes. Again, our focus is on publishing this data in a peer-reviewed journal. And again, the timing is dependent on that process. As with other programs, we will certainly provide updates as appropriate and once that process is complete.

Okay. Next question, what's the rationale for doing a share purchase agreement at this time given the company's cash runway extends to the second quarter of 2027. And Jeroen, could you please answer that?

Sure. Thank you, David. So this agreement enables us to strengthen our balance sheet as needed and at our sole discretion. So we're able to do this at any point in time over the 24-month term of the agreement. We maintained full control over the timing and amount of any sales as [ LinkoPark ] is required to purchase the stock at our direction. This arrangement has the potential to also bring us broader benefits as a company as well. For example, a backstop financing facility can strengthen our hand in partnership negotiations because we have other access to capital. Also, as a high-value investment opportunity arises, we can act quickly without the time and expense of a traditional capital raise. Back to you, David.

Thanks, Jeroen. Next question is also for you. Does Vaxart plan to use the additional capital for a specific purpose?

Sure. So yes, first and foremost, as I just said, the share purchase agreement provides us with the financial flexibility and optionality at favorable terms versus the more traditional rates. So we use this. So any use of proceeds will be determined based on our specific needs at the time of the sale. Our disclosures have stated that the funds are intended to be used for working capital and general corporate purposes. The objective would clearly be here to support our existing priorities. So that includes the advancement of our norovirus proband leading the ongoing collations and on other programs and develop our pipeline, as we just talked about, avian flu programs and other vaccine candidates. In any case, use of proceeds would be to really fund activities are value-creating and not merely to just extend our runway. David?

Thank you, Jeroen. Next question is for Steve. Can you explain the rationale for bringing Dr. Breitmeyer on to the board at this time? Are there any more changes to the Board planned?

So Dr. James Breitmeyer is a highly qualified pharmaceutical executive. He has experience being on board. He has extensive clinical and regulatory experience spanning 35 years. And as we were approaching some of our very important critical data milestones, obviously, including the upcoming readouts for our BARDA-funded COVID-1 program. Jim's experience and his track record of leading programs to 8 FDA product approvals really provides us with a distinct advantage. Furthermore, on top of his previous work, he also served as President of Bavarian Nordic, which is a vaccine company. And there, he oversaw the development of infectious disease and [ bioterrorism ] vaccines. It aligns perfectly with the work we're doing alongside our government partners. And that's the reason why we believe that Jim's expertise is really helping us navigate through this complex path from clinical development to regulatory approval, it will be invaluable to us as we work through validating our oral vaccine platform.

Okay. Steve, another question for you. Are any of Vaxart's directors planning to step down, or are you expanding the Board?

We regularly evaluate board composition and current skill sets to ensure that we have the right expertise to support the company's strategy and our stage of development. We believe that with the recent additions, the Board just does just that, right? As we demonstrated by the recent addition of Dr. Breitmeyer our focus is strengthening capabilities in areas like clinical development and regulatory strategy. And also as part of our ongoing commitment to Board refreshment with the addition of Dr. Breitmeyer, as a reminder, we've added two new directors in two years with significant drug and business development expertise and that really ensures that we have fresh perspectives on the board.

Okay. A couple of additional Board questions. Next one, Steve. Can you clarify the rationale for recent board changes, and how those decisions align with shareholder interests? And would you consider a retail shareholder representative to the Board?

Yes. So the Board believes it's important to bring relevant fresh perspective to the Board room regularly. And of course, the directors also need to provide rigorous oversight regarding the execution of our strategy. And so their skills and experiences are critical in this regard. And the recent board changes reflect a focus on ensuring that we do have the right mix of expertise to support the company's current stage and its priorities. This also includes strengthening capabilities in areas like clinical development, regulatory strategy, capital markets. Those are important to a company like Vaxart as we advance our programs. And these decisions are aligned with what the shareholder interests are by positioning the company to execute effectively and realize the maximum value of our platform and pipeline. As we've shown, the Board is open to fresh perspectives and would consider and evaluate any qualified nominee as part of the Board's nominating and governance committee process.

Okay. Next question. Why should shareholders have confidence in the current Board and any new nominees to create value going forward. Steve?

Yes, as I was saying earlier, our Board is actively overseeing our strategy, how we allocate capital and the progress that we are making. They're working closely with the leadership team and holding all of us accountable on the management team to deliver. In doing so, they're putting the company in the best position possible to enhance shareholder value. As I stated earlier, right, we added two new directors, and they bring the right mix of medical, business, financial and other relevant experience and experiences to -- and expertise to drive our company forward and also ensure that we have the cash runway to execute our strategy. Specifically, our Board benefits from our directors' broad mix of experiences across clinical development, regulatory strategy, commercialization, business development amongst many areas, and that's directly aligned with advancing our pipeline.

Thanks. Steve, what do you think about the role shareholders should have in the selection of Board of Directors?

Yes. So all shareholders, no matter how big or small of their ownership stake have a voice. Their vote matters as part of the annual meeting process. Our Board of Directors and management team are shareholders as well, and our interests are aligned with all of Vaxart investors. Our shareholders should know that our directors are committed to creating value, taking actions that are in the best interest of all Vaxart shareholders. They are overseeing a clear strategy to advance our programs, drive growth and extend our runway. So ultimately, we can create shareholder value.

Okay. Thanks. Steve, another question for you. How will you build investor trust and drive shareholder value with urgency over the next year?

Yes. So our top priority is delivering on the key clinical milestones, including the sentinel readout, as we discussed and the fully powered Phase IIb data later this year. So we believe those are the most important drivers of value. We're focused on disciplined execution, cost management, as we explained earlier, ensuring resources are directed toward the highest impact programs, while also maintaining our runway. And finally, our goal is to advance our clinical programs. So as I stated earlier, generating meaningful data and leveraging those results to support partnership opportunities and the broader value of our platform.

Okay. Thank you. Steve, next question. Do you believe near-term stock price appreciation is a priority? And how are you thinking about that versus longer-term strategy?

Yes. Our Board and management team are always focused on creating shareholder value for now and also for the future. We're confident that these steps that we're taking now to advance our pipeline, while also extending our run well -- runway will create the most long-term value for shareholders. At the same time, we recognize that the importance of creating value in the near term and believe that we can do so through these same drivers that will deliver sustainable long-term value. So it gets back to the science, delivering positive outcomes for patients, executing on our growth strategies and achieving the strategic outcomes we've been talking about.

Okay. Thank you. Jeroen, next question for you. There are questions on management balancing dilution risk with the need to preserve flexibility. And we also know people have asked when we would consider raising capital versus relying on partnership funding?

Thank you, David. Our our capital allocation strategy is really to balance the spending discipline with the advancement of our science with the ultimate goal of positioning the company for stronger strategic and financial outcomes over time. So in order to reach those outcomes, we need sufficient cash runway to execute the development of our vaccine portfolio over time. So we pursued and continue to pursue non-dilutive funding and partnerships as demonstrated by the ongoing support from BARDA and our Dynavax collaboration, which both have provided meaningful validation and capital. Our most recent agreement with Lincoln Park Capital is another good example of our capital raising strategy, and it's intended to provide access to capital as needed rather than requiring us to raise funds in bulk all at once. Finally, we're also realistic that we need to raise cash in other ways in order to achieve the outcomes we're seeking and ultimately maximize our shareholder value. I'll leave it there.

Thank you, Jeroen. Thank you. Steve, next question is for you. What's the plan and time line for regaining compliance and relisting on NASDAQ? And would a reverse stock split be necessary in order to do so?

Our focus is on executing our strategy and advancing our clinical programs, and we want to continue to focus on that. We believe that's going to be the primary driver of long-term value. And we do and continue to assess what's the best approach based on market conditions than the company's progress. So we want to really act in the best interest of the shareholders here. So it's really going to be executing on our strategy and advancing our clinical programs.

Okay. Thank you, Steve. The next group of questions is related to proxy and the annual meeting. So Ed, if you could take the first question, when do you plan to file your proxy statement?

Sure. So we will be updating our shareholders in due course with information about the annual meeting and of course, that will come through our proxy filings. And like all public companies, we have a shareholders meeting every year and shareholders will be hearing more about it in the future.

Okay. Thank you. And a few more questions for you related to this topic. Have you spoken to the concerned shareholder group?

So we do regularly engage with a broad range of shareholders, and we welcome dialogue and input from them, but we don't comment on specific conversations. We remain committed to listening to shareholder perspectives, considering them in our regular course and maintaining open lines of communication.

Has the concerned shareholder group notified Vaxart that they intend to nominate candidates to the Board? Have you received any nominees?

So we don't comment on specific shareholder communications, like I said, or on potential actions. But we -- when we have disclosure obligations, we, of course, take this seriously. And so when there's something to disclose, we'll do so appropriately. Our slate of Director nominees will be included in the proxy, which will be filed in the coming weeks.

Okay. A follow-on question. When was the deadline for the concern shareholders group to submit their proposal for directors?

So our nomination window for directors was between February 2, 2026, and March 4, 2026, so that window has closed. And of course, I'll tell everyone to stay tuned for our proxy filing.

Okay. Thank you, Ed. Checking on the Q&A portal, it looks like all the questions have been -- submitted have been covered, and we haven't received any further questions. So Steve, I'll turn the call back over to you for closing remarks.

Okay. Thanks, David. I want to thank you all for joining us today and submitting your questions. We appreciate how engaged all of our shareholders are. This is an exciting and important time for Vaxart. We are advancing our programs. We're on the precipice of releasing data and taking prudent steps to extend our runway and ensure we have the flexibility and resources to execute on our current strategy. We remain committed to creating safe, effective and accessible oral pill vaccines that protect our global communities and help people to lead healthier lives. In doing so, we are confident we can create sustainable shareholder value. Thank you again.

Greetings, and welcome to Vaxart's stockholder Fireside Chat Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the webcast over to David Carey, Finn Partners.

Good afternoon, and welcome to today's call. Joining us from Vaxart are Steve Lo, Chief Executive Officer; Dr. Sean Tucker, Founder and Chief Scientific Officer; Dr. James S. Cummings, Chief Medical Officer; Jeroen Grasman, Chief Financial Officer; and Ed Berg, Senior Vice President and General Counsel.

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, any partnerships with third parties timing of any anticipated regulatory approvals or that any such approval will be obtained, the company's future cash runway, ability to regain compliance with NASDAQ listing standards or raise capital if such listing is regained 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?

Thank you, David, and thank you to all our stockholders for joining us today. Before we get to your questions, I'd like to briefly recap the key developments we are focused on as we move into 2026. A significant milestone since our last talk is the closing of Sanofi's acquisition of our partner, Dynavax in February.

Our oral COVID-19 vaccine partnership continues to move forward with Dynavax which is now a subsidiary of Sanofi, and we have already established a productive working relationship with their team. This agreement is a key validator of the potential of our platform. Combined with our focus on managing operating expenses, including our recent lease termination, we continue to see a cash runway into the second quarter of 2027.

Regarding our clinical time lines, Our Priority is the execution of our Phase IIb COVID-19 trial. We are working in collaboration with BARDA and expect to report 12 months top line data from the 400 participant SENTINEL cohort early in the second quarter.

In late fourth quarter of this year, we expect to report the comparative safety and efficacy data from the 5,000 subject KP2 cohort. These results will provide important insights into both our COVID-19 candidate and the broader potential of our oral pill vaccine technology. In our norovirus program, we continue to build a strong body of clinical evidence. In January, we published data in NPJ vaccines from our study in lactating others, which demonstrated the potential of our oral vaccine to confer mucosal immunity to infants via breast milk.

To summarize, we are focused on delivering data, managing our resources prudently and advancing our partnership discussions across our entire pipeline. With that, we will now take your questions.

Thanks, Steve. So we actually have a good list of questions that came in beforehand. So why don't we dive into those first. So the first question is from Salazar S. And he asks, could you walk us through how the Dynavax partnership now functions following Sanofi's acquisition? Are you still working with the same team that originally structured the agreement? Or is it -- is there a new group within the Sanofi involved? And ultimately, who is responsible for deciding whether the program progresses to the next stage.

Steve, could you answer that one, please?

Sure. Yes. Thanks for the question. So yes, we continue to meet very closely with the original Dynavax team that had structured this partnership. We have ongoing discussions on how the trial has progressed, et cetera. And as a reminder, we maintained full operational and responsibility for the COVID-19 program until the completion of the Phase IIb trial. Now as a reminder as well, that trial is funded by BARDA. So essentially, it's a Vaxart and BARDA to the end of Phase II.

After the data packages finalize at the end of Phase II and present it to the FDA, Dynavax or Sanofi will have the formal decision to take over the next stages of development. And if they elect to move forward after Phase IIb then Vaxart would be eligible for a $50 million milestone payment. So that's really at a high level, how it's structured.

Okay. The next question comes from Travis. Why hasn't the Phase IIb started for noro? If the FDA recommends delaying Phase II again, what options and plans does Vaxart management have to continue trials? .

And I will turn that question over to James.

And thanks, Travis, for your question. The FDA has never recommended to laying a Phase IIb for us. That said, we are looking or looking at doing additional preclinical work in evaluating a strain change that occurred in the circulating changes -- strains for norovirus. So we want to make sure that we're fully covered with what moves forward. As I said previously, the start of the next norovirus trial, a Phase IIb is contingent on securing a strategic partnership or other nondilutive funding. There still remains a lot of interest, and we have been having ongoing discussions with some of our potential partners.

Next question is from Hilda C. Are there any further steps with the lactating mothers study for norovirus. James, can you take that one as well?

Thanks. So [ depending ] partnership or other funding really, as I just mentioned, we plan to initiate our next norovirus clinical trial with that partnership or funding in 2026. For that lactating mother study, the passive transfer of IGA to infants, it was an exploratory, but really a very highly compelling outcome.

The observed transfer antibodies from vaccinated women to infants through their breast milk suggests that the oral norovirus vaccination could enable a novel approach to confirm mucosal anti-norovirus community really to a population that's highly vulnerable to norovirus infection. And we're looking to see if we can obtain funding to further explore this novel approach.

Okay. The next question is from Diane H. Has there been any feedback from the government initiatives for pandemic preparedness platforms and adjuvants? And I will turn this question over to you, Sean.

Thanks, Diane, for your questions. Obviously, Vaxart has been very good about seeking out nondilutive funding in the past. I don't have an update today on anything on the new initiatives. But keep in mind, I want to ensure that to the stockholders that we are exploring all potential funding options, including nondilutive partnership opportunities for our early-stage assets. This includes our seasonal and pandemic flu candidates.

To be clear, these government awards can take a while to get to completion, so we -- and we don't report on our efforts until we have an efficient agreement. Keep in mind, of course, we are very confident in the value of our oral pill vaccine platform and are committed to realizing its potential addressing entrenched public health challenges and emerging personal preferences regarding vaccination.

Okay. Thank you, Sean. The next question is from Justin W. And he asks, BARDA has recently issued RFIs around next-generation vaccine platforms and immune assay development through programs like ASSURE. Has Vaxart participated in those initiatives? And do you see potential opportunities for the platform there? And James, I'll ask you to answer that one as well.

Okay, Justin, thanks for the question. So Our team tracks a lot of different streams of non-dilutive funding, such as the initiatives -- some of them you mentioned from BARDA, but there's more and other government agencies as well as NGOs. And we weigh each opportunity very carefully and engage on those that we think makes sense from our time and capability standpoint. That said, we only disclosed our involvement in specific programs, et cetera. when material funding secured, which can take a little while over.

Next question comes from Tom G. And this is related to sentinel cohort. Why did your time line slip from Q1 to early Q2 for the sentinel cohort data readout? And James, can you please answer that one?

Sure, Will. Tom, thanks for the question. As we've shared today, I think but also during our call yesterday, I don't know if you caught it, both parties, both BARDA and Vaxart, must come to a mutual agreement on the timing for release as part of our agreement, right?

The data for that cohort as being ready for unblinding, but we remain unblinded and we've been working very closely with our BARDA partners to finalize the process and the plan for analysis of that sentinel cohort. These important matters are really responsible for the small anticipated delay in unblinding, but I'm looking forward to getting that data out there. I will say and underscore, we appreciate the partnership with BARDA, and we look forward to presenting the data early in the second quarter.

Okay. Thank you, James. Next question -- another question actually from Diane H. In an October article, Sean stated that additional preclinical data from pandemic flu would be released soon. That data never came and were almost in Q2 2026. Where is that data? And Sean, I'll turn that to you. .

Yes. Again, one of the key things that we want to do with this data is we want to get the data published in a peer-reviewed journal, something that's of high tier status. And obviously, when you're through the process, we have no control over it, whether it takes longer to get through the reviews and [ returns ] and everything else. And it just takes a while that I can't predict all the time. Obviously, once the paper is accepted, we will keep you all updated as appropriate.

Thank you, Sean. The next question comes from Piyush P and he asks now that the cash runway is extended to 2Q of 2027, I do not see any immediate need to raise cash via nondilutive methods -- I'm sorry, via dilutive methods. Can Vaxart management clarify that there will not be any reverse split proposal, at least till the end of 2026 now that the cash runway is until 2Q 2027? I just want some sort of clarification from Vaxart that there will not be any need for any reverse split for this year. And Jeroen, I'll turn it over to you.

Yes. Thank you, and thank you for you, Piyush, for the question. So we think the best way to create long-term shareholder value for us to advance our vaccine science and bring safe, effective and accessible solutions to the market to protect communities worldwide. Executing on that machine requires ongoing funding. And while our preference is to bring this funding in from partnerships and nondilutive fundraising options, we also need to consider other financing options to meet the needs of the portfolio. So with those needs in mind, we're evaluating our current OTC market listing and the fundraising opportunities provided and considering whether that's an optimal fit with our needs.

One of the things we have seen, [indiscernible] on the OTC exchange for, I guess, about 8 months since we got delisted in July of 2025, certain institutional investors have sold out of their holdings likely because of our listing on the OTC and others that we've spoken to have said that they sort of really appreciate our science and the commercial opportunity it represents, but have told us they cannot invest as long as we're listed on OTC. Those are some of the things we're considering here. So I'll hand it back to you, David.

Okay.. We have another question from Salazar. And he asks around 12 to 18 months ago, there was considerable uncertainty surrounding vaccines. How is the funding environment evolved in that time? Do you feel much of that uncertainty still exists today? Or has it decreased? And kind of the second part or have you had any discussions or interest from organizations such as the Gates Foundation or similar global health groups that might support a Phase II norovirus program. And Sean, I'll turn that one over to you, please.

Thanks for your question, Salazar. Obviously, we recognize the current domestic environment for vaccines kind of in a state of flux characterized by increased scrutiny, particularly for the mRNA vaccine and evolving public sentiment. I do want to stress that we're just not another metoo injectable vaccine. Our oral pill platform addresses primary drivers of U.S. vaccine fatigue, needle hesitancy and the desire for more convenient, less invasive health care options. .

We believe our technology could be the specific innovation required to reengage the domestic market in a post-pandemic era. It's also worth to note that in contrast shifting domestic landscape, the global demand for effective immunization remains remarkably strong and is growing major international stakeholders, including [ GABI ] and the European Commission have recently committed over $9 billion for the 2026 -- 2030 cycle to protect 500 million children.

These global programs are increasingly prioritizing thermostable and easy to administer vaccines that solve the logistical challenge in low-resource settings. This is exactly where our room temperature stable pill may offer its greatest competitive advantage.

Okay. Next question is from MP [indiscernible], assuming positive COVID data later this year, what would be next steps in your partnership with Dynavax Sanofi, and Steve, I'll turn it over to you .

Great. Looks like there's some many questions on Dynavax Sanofi, which is great. Happy to once again provide some more detail. So once again, we're currently in Phase IIb backstarts with the funding of BARDA is in charge of this all the way to the end of Phase IIb. Then once the results are out, and I'm glad that you're asking that they're assuming positivity because we will assume the same. We will then provide a data package to the FDA and that at that point is when Sanofi or Dynavax has the decision to decide to whether or not to advance the Phase III.

Once that decision is made, then they take over the program, Vaxart receives $50 million for that option. And on top of that, we remain eligible for up to $700 million in license, regulatory milestone fees, tiered royalties as well as the equity investment. So bottom line is, as we get to the end of Phase II data, that's when the decision will need to be made.

Okay. Steve. Next question is from Jessica M. And she asks, can you quantify the expected annual OpEx savings from the lease termination effective this May? And Jeroen, I'll hand that one to you.

Sure. And thank you, Jessica, for the question. So the accelerated lease termination agreement is part of our overall strategy to streamline our cost structure over time. You're aware, we downsized some of our employee base last year, and this is just an additional piece on top of that. So we disclosed in December 2025 that this agreement allows us to terminate one of our leases in May of this year 2026, rather than March of 2029.

So this allows for additional savings on top of the year-on-year lease expense reductions we already showed for 2025 and the 10-K. There will be an upfront cost associated with the lease termination, but we expect to realize savings of well over $1 million per year over the next several years until that ends in March 2029. The savings clearly from this termination agreement will allow us to shift the associated funding back to advancing the portfolio as we all prefer.

Okay. Thank you, Jeroen. Next question is from Tanya A. Over the past year, Dr. Sean Tucker has mentioned in several forms that Vaxart expected to release data from its Avian influenza program before the end of 2025. Since that data has not yet been shared publicly, could you provide an update on the status of the Avian influenza study and when investors might expect to see the results? Sean?

Thanks, Tanya, for your question. As we said earlier or last year, I should say, we completed the primary analysis of the H5N1 Avian influenza study and it yields a highly successful result of 100% protection with our vaccine against death, I should say, the gold standard [ FAIR ] challenge model. The data really did confirm that our oral pill platform's capability of protective immune response against this highly pathogenic strain.

As I just mentioned earlier, the plan is to publish that in a peer-reviewed forum in due time, but we have no control over that process, and it takes a while to go through further. I'd just like to say that we're -- the desire is to move that forward into the clinic at some point. And obviously, we're looking for a partner to provide some funding on that aspect.

Okay. We have another question from Salazar S. And actually from -- a similar question came in from Justin W. So I'll read Salazar question. You mentioned the possibility of advancing the norovirus program into Phase II independently, noting that some potential partners may be waiting for [indiscernible] results before committing? And then Justin continues, what factors would determine whether Vaxart moves forward independently versus with a partner? Steven, could you take that one?

Yes. So in terms of just the norovirus program, we always want to keep our options open. Evidenced by how we were able to secure a partner for COVID with Dynavax, that's always one of the options. And we do continue to have conversations with potential partners. At the same time, we certainly believe in what we're doing with norovirus.

And if we could afford it, we would certainly move the program forward. As Jeroen had mentioned, right, our cash position takes us to the second quarter of next year. And for the study, we would have to look at raising capital. And as a company, we look at whether this is a good time or a bad time to raise capital. And as Jeroen had mentioned, right, we don't have as many institutional investors who can invest with us on OTC.

So it really does, at this point, leave us with continuing to look for nondilutive partnerships. At the same time, we are monitoring what Moderna is doing, and we certainly don't want to wait too long because. Should the results come out of Moderna, we think we would be in a great position to compete with them, right? They're an mRNA.

We have a much better delivery platform as well as the scientific advantages and that's our belief, and that's why at the same time, we've been talking about how we would try to find a way to advance that forward. So hopefully, that answers both of those questions there.

Okay. Taking a clarifying question, James, this is a question from Michael P who sent in this question just now. And his question is, did James just say that the data is unblinded, the BARDA and Vaxart are figuring best time to release. And if that was not the case and this data -- and the data is still not available or ready to be published, what are your thoughts on why it seemed like we would be able to get the data by the end of Q1. And now that there is the delay for early Q2, basically, what could be the reason for this?

Thanks for the question. So the projection for Q1 was made several months ago. And I think that was our best estimate of when we could come forward with that. But as I mentioned in the initial question or 2, we can't move forward with unblinding analyzing or releasing data without the agreement of our partners at BARDA. And it's currently in the process of discussions with BARDA. So right now, I remain unblinded, the team remains rather blinded. We are blinded, let me emphasize, we are blinded as is BARDA. And we await a thumb up from BARDA to analyze the data. The data for this initial sentinel cohort, again, it was built for safety. We'll get some streams for some indications of efficacy. But that will be done by an unblinded independent statistician.

We will remain blinded as to which individual volunteer got what vaccine until the database is fully locked at the end of the KP2 cohort. I hope that, that answers that question.

Next question is from Leslie P. With Moderna's Phase III moving forward, how does the passive transfer data in lactating mothers improve your competitive positioning? Is a pediatric first or maternal first strategy, now a primary focus for your partnership discussions? And Sean, I'll turn that one to you.

Thanks for the question. Just to be clear, obviously, most of our work in norovirus has been done in adults. We did this nice experiment with the funding with the Gates Foundation to sort of address youngest of infants. And I think the key thing about this is this passive transfer data demonstrates just how powerful the platform is for making antibodies and antibodies that could be transferred to the infants through breast milk. .

In a comparative way of looking at this from the standpoint of Moderna, there's been some publications that suggest that with their COVID vaccines, they were able to see transient levels of breast milk in very low levels, which is unlikely to really result in much transfer to infants.

So I think the key thing from our standpoint is the mucosal response that we have demonstrated through our platform would be really difficult for mRNA to replicate. And ultimately, I think this date is going to add the potential promise of our norovirus program overall.

And here's a follow-up from Leslie P. she asks how soon after signing a noro partnership do you think you could get the trial up and running

Yes, I'll answer that question. Thanks again for it. I think that depends on the partner and the nature of the partnership because the partner may decide -- they want to do something more intensive than what we've designed in the past and it would just take longer to execute. .

Okay. Next question is from Justin W. in your partnering discussions, have you seen strategic interest in the entire oral vaccine platform itself beyond traditional licensing discussions. And Steve, I'll turn it over to you.

Yes. So we have a range of discussions and conversations. It really depends on the folks we talk to. And so yes, it is a range. Some are evaluating asset. Others are evaluating the platform. One of the things I'll also add, I know we don't spend as much time talking about this, but we have a very unique oral delivery platform. And there are some companies who think about life cycle planning or if they're in a competitive environment, how a different mode would actually make them more competitive.

So there's some conversation around just do they have an antigen that wouldn't work on our platform, and that's something that Sean and his team often we'll take a look at and evaluate. So we look at it not just by assets, but we also look at it in terms of the platform itself.

Okay. Next question is from Ernesto G. And Ernesto asks, are you trying to partner out any other programs such as avian flu? Steve, could you take that one?

Yes. So the short answer is yes. Avian flu and Sean can comment on this, right? There's -- many times, it's very newsworthy and sometimes it's not. We've actually been monitoring rates and so forth. So there's -- sometimes there's a lot of discussion, so sometimes there's not. But perhaps I can let Sean...

Yes. I mean this is a very interesting indication from our standpoint. We do think that we have a good solution, we could move forward. This might be one of these things where the government support probably important to start to get it off the ground and move it forward..

Okay. Next question is from Tanya A. Vaxart is currently trading on the OTC market after falling below NASDAQ's $1 minimum bid requirement, could you clarify the pathway for relisting on NASDAQ. Specifically what minimum share price would the company need to achieve? And how long would that price need to be maintained in order to qualify for relisting. And Jeroen, could you please take that one?

Yes. No, absolutely. Happy to. Thanks, Tanya, for the question. Really glad you asked that question since we've received about -- the questions about this topic in the past, and I'd like to correct common misconception, I guess, that we only need to achieve a minimum share price of $1. So we mentioned earlier that the return to NASDAQ would clearly be critical for the company, even open up multiple avenues for funding for additional investors who are unable to invest in an OTC company at this time.

So while maintaining a listing on the NASDAQ requires a minimum bid price of $1. Once you're delisted and you're looking for an uplisting from OTC to NASDAQ, we must achieve a minimum bid price of $4 per share and maintain that until the NASDAQ uplisting decision.

Okay, Jeroen. The next question is from Anil K, and he asks, can you provide further explanation regarding the March 10, 2026 modification of the BARDA contract. It mentioned an increase, but then a future expected decrease in the 10-K. And I will turn that over to Ed to respond.

Thanks, Anil. Good question. We tried to be clear. But to clarify it for you, there are 2 things that we are tracking. One is the overall amount of funding available in the award. And the other is the actual dollars that have been released to us to spend for the program, which if you've been following our disclosures, there's been an ongoing increase.

So the latest modification will continue to increase the dollars. But what hasn't happened is we haven't gone back to the overall award and taking into account the fact that we had a second stop work order and instead of doing 10,000 patients we're doing something in the range of over 5,000 patients. We expect that the subsequent modification to this one, we'll take that into account. It will increase funding, but it will decrease the overall award.

That's probably where the confusion is taking place. So we are going to see more dollars coming in, but they're not going to ultimately be $460 million. I hope that helps.

Thank you, Ed. We have another question from Diane H. And actually, several people have asked this question that have come in. The time frame of the [ Altessa ] milestone payment is important for runway. Can we get that information? And Jeroen, I'll turn that over to you.

Yes. Thank you, Diane. I appreciate the question and others as well, I guess. A little bit of context here. So Vaxart originally acquired this drug through its 2018 reverse merger with Aviragen Therapeutics. And then subsequent to that, in 2021, Vaxart and Altesa Biosciences entered into an agreement where Altesa was granted the worldwide exclusive rights to develop, manufacture, commercialize the drug called vapendavir. As we disclosed at the time, we're eligible for up to $130 million in development and commercial milestones.

And once the drug reaches the market, we'll receive tiered royalties on their global net sales. So at this point, though, we can't really estimate when this drug would make it to market. But we're clearly excited as you are that the drug is advancing in the clinic. As most recently disclosed by Altesa, the drug is entering a Phase Ib and they've received funding to advance this drug. But as to further timing, it's in their hands, not ours.

Thank you, Jerome. Next question is from Glenn H. And he asks why give us dates for releasing data if you have little to no control over the data for a lease. And I'll turn that over to Ed to respond.

Yes. Thank you. I can understand the frustration, but we want to give information to our shareholders. And in fact, we're required to under our filings and we do the best to make an estimate of what we think will happen in the future. And then we're very careful to say these are forward-looking statements that we can't predict the future at any better than anyone else can. We have a partner here, and we thought we had a high likelihood of making it to our lease in the first quarter.

And in fact, if you go back to what James said, the data is ready to be unblinded but we remain blinded. And if it had been unblinded, we would essentially be more or less required to release that data publicly, especially if we're talking to shareholders or the Street, et cetera. We have to work with our partner at BARDA, and it turned out there were more issues to work through than we had thought.

We appreciate all the efforts that they are taking, and we are working closely with them. And I think what we saw was a relatively small change in the delivery and unblinding of this data, really the unblinding, not the delivery. And that's why we changed the guidance. And that's what we always do when we when we find out new information, we provide the next available disclosure, if not sooner. So that's why we are doing what we're doing, and we'll continue to do it. We'll continue to give you the best information we can and let you know when something changes

Thank you, Ed. Next question is from Justin W. Another question from him. He asks you recently met with Taiwan's Development Center for Biotechnology regarding the oral vaccine platform. Can you share what areas of collaboration that were discussed and whether that engagement is focused more on research collaboration, manufacturing or regional commercialization. And Steve, could you please take that one?

Yes.

Justin, so this is a great example of what we had said in the past that we will go to the ends of the Earth to find ways to partner, look at global opportunities, et cetera. So we were certainly pleased when we were invited by Taiwan's development center to speak to them. Actually, Sean was the 1 who did most of the talking.

He did a great lecture, I'll say, Professor Tucker in that regard where they had a lot of questions on our technology and how we could work with some of the companies that are in Taiwan. It was just the first visit, so pretty early stage. I think we'll continue some of the conversations at a future date. But once again, it's also another example of how we do want to look at global reasonable partnerships there may be companies that have an antigen that they want to try on our platform, et cetera. There's also nondilutive funding. And so we just continue on our game plan of not limiting ourselves just to the United States, but looking at global opportunities.

Next question is from Carla K. Does Vaxart believes it is okay for the CEO or members of upper management to actively engage with retail individuals? If so, I would like to see the correspondence. And Steve, I'll ask for your perspective on this and you might have some comments as well.

Sure. Yes. So the short answer to your question Carla, is yes. I mean we're doing that right now, right? We're actively engaging with all of our stockholders today. This is the third quarter in a row that we've had a fireside that. We promised we would do these, and we've stayed on that time line of engaging with our stockholders, whether you're a retail stockholder or whether or not you're an institutional stockholder, public companies do interact with their investors.

I will emphasize that whenever we have these interactions, we never share confidential information. Even as evidenced today, all the things we're talking about today our public information. It's things that we referenced in our 10-K and all of our disclosures, we're certainly providing some additional color behind it to explain what some of those statements are -- and I think that's just an important way of how we should be operating as a company.

The stockholders are important to us. You are the ones who are hopefully funding. All the things that we want to get done and the science that Sean has invented, et cetera. I'll turn it over to Ed, if you want to just add some additional comments.

No, I think we are very careful with regard to our disclosures, and we are very thoughtful about how -- what we need to disclose, when we need to disclose it. And of course, the idea is we're never disclosing it selectively. We're always disclosing it in the public way. One way in a way that is accepted by law. And the entire management team has undergone training on that. So I'll stop there and and say that we will continue to do that.

Okay. The next question is from Keith and he asks, can the Vaxart team discern with any degree of certainty or form a reasonable conclusion of which participants received which vaccine in the 400 sentinel cohort from the data produced from each participant to date without the data being unblinded.

And James, I'll ask you to respond to that. James, are you there?

I'm sorry, I had a little technical difficulty. So I just want to thank, Keith, for the question because it's -- it appears that there's been some, I wouldn't say obfuscation, but perhaps lack of clarity, maybe on my part. So just to be clear, we are blinded, right? We remain blinded. And although the aggregate data for that sentinel cohort will be viewed by an unblinded independent statistician, I'll remain blinded, right, as will our friends at BARDA, the only others that are unblinded to safety are DSMB with which we meet every other week or monthly at this point in the study.

To get to the second part of your question, because we remain blinded, there's no way I have of knowing which vaccine was given to which participant in the sentinel cohort nor should they be, right? The blind is doing what it's supposed to do. And again, that won't be unblinded it large until the data lock and [indiscernible] study. I hope that answers your question, Keith, and thanks for the opportunity to add some clarity there.

Okay. Next question is from Christian L. And the question is, have you considered using other technologies, antigens in the platform? And have you been approached by other potential partners by doing some data testing. And Sean, I'll turn that one over to you.

The short answer is, yes, people have looked at our platform and thought that it might be a good way of approaching their vaccine problem and have suggested making -- taking their antigen and putting it into our system. So the short answer is really. Yes. People have contemplated it. We've been approached. And if there's something useful or interesting to report, we will be sure to do that.

Thanks, Sean. James, a question for you, and this is from Daniel H. Will the sentinel cohort be large enough to confirm correlates?

The answer to that is no. And sentinel cohort, the cohort XVP of 400 individuals is big enough to give a reasonable safety signal for the continuance of the study. That's how it was built. So in terms of confirming correlates or confirming efficacy or any of that, that's something that we look towards the larger KP2 study [indiscernible] more data on.

Thanks, James. Next question also continuing on from Daniel is where the employees from HQ work. So this is a couple of employee-related questions. So how many employees are open to work? What's the current headcount and where will employees from HQ work? And Steve, could you respond to that?

Yes. So most of our employees do work here in South San Francisco at headquarters. I'm sure you're referring to our lease termination of one of our leases. And as a result, we'll still be working in South San Francisco, but we're consolidating into the other facilities. So again, it was a great opportunity for us to terminate a lease, decrease some of our spend on real estate, which we prefer to repurpose to other areas such as research and development. But we will still all be primarily here in South San Francisco.

Maybe adding just 1 more piece. As disclosed in the 10-K, I guess, our head count at the end of 2024 was about 105 employees. At the end of 2025, it's about 65. So this is what allowed us to consolidate our head count into a smaller footprint and take these savings. And again, the shift funding from infrastructure spend to program advancement.

The next question is from Mohamed K. Considering the partnership approach now being pursued, and with no expectation of in-house commercial vaccine manufacturing for at least the next few years. Why is the company continuing to incur such high monthly cost maintaining expenses in-house manufacturing facilities? These expenses should be drastically scaled down and aligned only with the needs of upcoming clinical trials, which themselves are not much expected in the near term. Steve, could you take that one?

Yes. So Mohammed, that's a great question because this is actually what we have been doing and have done. So as Jerone had mentioned in the prior question, we have reduced our headcount. A majority of the reduction was in the head count in manufacturing. And let me just acknowledge, we've had some really great hard-working employees and we value everything that they've done. And the ones who are still on the books, we work hard and harder every day.

But I also will say that we have maintained a very small manufacturing footprint here in South San Francisco. It is for clinical trials. And as there were lots of questions around being ready for a norovirus trial, we have to be ready and be able to manufactured to be ready for that trial or as well for other trials as well. But again, it's a much, much smaller footprint. I'll also emphasize that our facility is here in the United States.

And with the Trump administration, you may be aware that there is great emphasis on having manufacturing based in the United States. We're proud that we have that, and that's also an important factor, especially with our relationship with BARDA.

Okay. Next couple of questions are from Steve S and to a degree, these have already been asked, but I think it's important to ask again, and just for clarification purposes, James. Understanding that BARDA can control if and when unblinded data is released to the public, can you confirm if the Vaxart team themselves have seen this data yet? Was the update to Q2 release time frame communicated to you by BARDA? Or is it something you have concluded just based on it already being mid-March. If BARDA did communicate the delay, did they share the reason for it?

Okay. Thanks. I appreciate the question. So if you go from the top, I can confirm that no members of Vaxart team has seen unblinded data because, as I mentioned before, we remain blinded, and we will remain blinded until database lock. The only people who have seen unblinded data, and this is in the safety forum is our independent data safety monitoring board. .

We would like to have our independent statistician, be unblinded and look at the XBB sentinel cohort data and report back data in aggregate. That is sort of the sequence of events, but we will remain blinded. So that I can confirm. In terms of the Q2 release time frame and whether or not that was communicated by BARDA, BARDA didn't call up and say, "Hey, hold your horses, you're going to have to wait until Q2."

This is just us trying to be as transparent as we can to the investors in the community saying, we thought it was going to be ready at the end of Q1. We're still in discussions with BARDA as to what all that means. And I think our General Counsel Ed Berg sort of delineated what those parameters are. So Ed, if you want to give any more clarity on that, please do. But no, BARDA didn't just call up and say, you're not going to be able to present until Q2.

It's more so where we are right now in the process and our best estimations of when that data would be available. I hope that answers your question, Steve.

Steve had a second question as well and perhaps you could respond to this one. In the course of due diligence, the Dynavax and by extension Sanofi review blinded trial data that hasn't yet been made public. Is it possible that any valuable information could be gleaned from the blinded data, given that the trial is a comparator with a known entity with a recognizable immune response.

So I'll take the second question first and then [indiscernible], right? So in terms of information gleaned from blinded data, I'd say no. And let's take a look at what that means. Let me unpack it for you. The XBB sentinel cohort, we have ideas on an aggregate what that might look like but we remain blinded. We don't know who got what. If you're trying to apply a recognizable, this has -- I think you said an immune response, we won't have immunogenicity for this initial cohort until after we have the top line tranche of data, which would be a granular safety and some efficacy streams, right?

So the immunogenicity will come later. But again, we will remain blinded. So I don't see how that would be helpful, but that's my opinion. In terms of due diligence, I'll let Steve or Ed speak to the complexities of that relationship. I can tell you that we have been in discussions with Dynavax since that partnership agreement. And it's, I think, a very good partnership and working forward. But Steve or Ed, would you like to comment on that second piece for Dynavax.

Yes. I'll just add, and I know you're getting a theme from Dr. Cummings, but we are all blinded. We do not know the results Dynavax does not know the results. Sanofi doesn't know the results. And so that's essentially how the clinical trial should be run. As Ed mentioned, and please chime in if those results are unblinded, there is an obligation to share.

Yes. I think that's both -- there's an obligation to share -- and I would say also, look, we can't speculate what causes a partner to decide or not decide to partner at a specific time. I know there's been some questions associated with that. I think they have what you would expect with regard to decision-making, which is if they get in on something in front of some new data, maybe they've made a really good choice if they get on something after the data, they may have to pay more if there are multiple partners who would like to partner with us.

We are always listening to other strategics and what their desires are for data and whether partnership is something they are interested in on what the terms would be. And of course, all those discussions remain confidential until they come to fruition and there's something to announce. That is common throughout the industry and it's common. It's common for us in our partnership discussions. So I'll stop there.

Okay. We're running out of time. So we'll take one more question from Daniel H. And he asks what is the current operational status of the [ Mitten GMP ] manufacturing location? Is it active, staffed and producing material? If it's not currently active, how does the company plan to manufacture clinical-grade vaccine material for clinical trials, including norovirus Phase II and then BARDA-related work. And I would turn it over to, I guess, either Steve or Jeroen.

Yes, I'll start first. So as I had mentioned earlier, we were in the process of consolidating facilities in order to save dollars. The Minton Road location is not the only location where we have GMP capabilities. And so I'll just say that we have multiple options within our current footprint.

Yes. No, that particular site was part of the consolidation efforts in 2025. So as you see in the 10-K facility costs, those were reduced from '24 to 2025, and that was a result of the Mitten Road closure and consolidation of capabilities in our other facilities here in South San Francisco, just like for the office facilities, we're consolidating our HQ in the other parts. So it's a 2-step process for both office and lab this year as well as last year, the consolidation of manufacturing GMP facilities. .

Okay. Thank you, Steve, Jon. Steve, I'll turn it back over to you for closing remarks.

Okay. Thanks, David. Let me say thank you again for everyone's time. And I will say that all the questions are very thoughtful, and we really appreciate the engagement. And we certainly hope that the fireside chat series has been helpful to everybody. I'll close with saying that we are operating with a clear focus on our clinical milestones as we move our oral vaccine platform forward. .

We remain confident that our technology can fundamentally change how vaccines are delivered and accessed globally to address significant public health needs. So we do look forward to updating you as we reach upcoming data readouts throughout 2026. Again, thank you, everybody, for your active engagement. Operator, you may close the call.

Thank you. This concludes today's webinar. You may disconnect at this time. Thank you, everyone, for your participation.

Greetings, and welcome to the Vaxart Fourth Quarter Business Update and Year-end 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. Thank you. You may begin.

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 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 several business updates, and we'll then pass the call to James and Sean for the latest program developments. Jeroen will then share an update of our fourth quarter and full year 2025 financial results, and I have a few closing comments before we open the call for your questions.

Now moving to our recent operational updates. Vaxart achieved several recent key milestones. First, we established a partnership with Dynavax for our oral COVID-19 vaccine candidate. Second, we expanded our clinical body of evidence by publishing the complete data set from the clinical study of our oral norovirus vaccine candidate in lactating mothers. And third, we continue to manage our costs as evidenced by our entering into a lease termination agreement that will provide significant cost savings by allowing us to terminate one of our leases early. As announced in November 2025, we established a partnership with Dynavax for our oral COVID-19 vaccine candidate. At the time of the announcement, we received a $25 million upfront payment and a $5 million equity investment, which was at a premium to the closing price. This partnership provides significant validation of our oral vaccine platforms potential, coming from a company with a proven track record in developing and commercializing innovative vaccines. It also extends our cash runway.

In late December 2025, Sanofi announced its acquisition of Dynavax, a transaction that officially closed on February 10 of this year. Sanofi is a global leader in the vaccine space, and we are pleased to be moving forward with Dynavax as a Sanofi company. Over the past 3 months, we have established a highly productive working relationship with our collaborators and our focus remains on executing and completing the Phase IIb trial and delivering those results. Under the terms of our agreement, we will receive an additional $50 million if Dynavax elects to continue development following submission of the Phase IIb data to the FDA. We also remain eligible for up to $195 million in future regulatory milestones, $425 million in sales milestones and tiered royalties in the low- to mid-teens. This agreement represents a total potential value of up to $700 million in license, regulatory and milestone fees, tiered royalties and the equity investment.

Previously, we discussed our commitment to managing our financial resources for maximum effect. This includes pursuing revenue-generating business development agreements, such as our partnership with Dynavax. It also includes looking for ways to reduce our operating costs without compromising our ability to realize the potential value of our pipeline programs and platform technology. Towards this end, in December 2025, we entered into a lease termination agreement with one of our landlords, which will allow us to terminate one of our leases on May 15, 2026, rather than March 31, 2029. This accelerated termination will help to reduce our operating expenses and enhance our ability to focus our financial resources on advancing our lead programs.

I will now turn the call over to Dr. Cummings for an update on the status of our clinical programs. James?

Thanks, Steve, and thanks to everyone for joining today's call. As a reminder, we are currently conducting a Phase IIb trial of our oral COVID-19 vaccine candidate compared with an mRNA vaccine. The primary endpoint of this study is the relative efficacy of our oral pill vaccine compared with the mRNA vaccine for 12 months post vaccination. The trial will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction and adverse events in each cohort. Most of you are aware that this trial initially was designed to enroll 400 subjects in a sentinel cohort designed to assess safety of our oral COVID-19 vaccine candidate and 10,000 subjects in the KP.2 cohort with half receiving our oral candidate and half receiving an injected mRNA vaccine. We announced in October 2025 and that BARDA amended the work order for this trial and is now providing funding for follow-up for the approximately 5,400 subjects enrolled in the trial prior to a stop work order issued on behalf of BARDA in August, 2025. This comprises 400 subjects in the sentinel cohort and approximately 5,000 subjects in the KP.2 cohort enrolled in this trial. As COVID-19 continues to impact global health, the need for next-generation solutions remains clear. We expect to report 12-month top line data from the 400 participant sentinel cohort early in the second quarter of 2026. The actual timing will be determined in collaboration with BARDA. As previously shared, we are contractually required to consult with and receive approval from BARDA regarding the timing and content of all press releases related to this trial. When announced, we expect to include data related to the primary safety endpoints for the sentinel cohort as well as initial data on efficacy measures. It's important to remember that the 400-person sentinel cohort was established specifically to assess safety and not designed to determine efficacy. The data from the 5,000 subjects KP.2 cohort will provide efficacy insights, and we expect to report them late in the fourth quarter of 2026. Here again, the actual timing will be determined in collaboration with BARDA. As I've commented before, we believe the results of this trial will provide important insights into potential of our COVID-19 candidate as well as our oral pill vaccine platform technology. The former is critical to advancing development of the COVID-19 candidate, while the latter is expected to inform development of our other pipeline assets. Our oral norovirus vaccine candidate is 1 of those assets. As Steve mentioned at the start of the call, we published the complete data set from the clinical study of our oral norovirus vaccine candidate in lactating mothers in January 2026 in npj vaccines. The Phase I multicenter, randomized, double-blind, placebo-controlled, single-dose dose ranging study was designed to evaluate the safety, tolerability and immunogenicity of an orally administered bivalent GI.1/GII.4 norovirus vaccine in healthy lactating women. The primary outcomes of the study were safety and reactogenicity and breast milk and serum norovirus-specific IgA. I'll briefly review the information that was provided in our January 15, 2026 press release announcing the data publication. The study enrolled 76 women, 18 to 43 years of age at 5 sites in South Africa. Participants were randomized into high or medium dose vaccine or placebo. The data demonstrate that the vaccine was safe and well tolerated and reports of mild or moderate adverse events or AEs were similar between the placebo group and each of the vaccine groups. And no AEs beyond Grade 2 were reported. Results for serum and breast milk IgA at day 29 post-vaccination showed that serum norovirus-specific IgA rose an average of 5.6-fold in response to GI.1 and 4.7-fold in response GII.4 in the high dose group. Breast milk norovirus-specific IgA rose on average, fourfold in response to GI.1 and sixfold in response to GII.4 in the high-dose group. And each of these breast milk increases was statistically significant and maintained through day 180. The passive transfer of IgA to infants was exploratory but a highly compelling outcome. The data show a consistent trend of increased GI.1 and GII.4 specific IgA in the stool from the paired infants of vaccinated women at days 29 and 60 and demonstrate a positive association between levels of IgA and maternal breast milk and infant stool, supporting the hypothesis of passive transfer of mucosal immunity. This observed transfer of antibodies suggests that the oral norovirus vaccine could enable a novel approach to confer mucosal antivirus immunity to infants or highly vulnerable to norovirus infection. Children under the age of 5 years can experience severe disease from norovirus infection, particularly in under-resourced areas.

The potential to protect infants from severe norovirus associated disease through oral vaccination and others could have important public health benefits, with respect both to reducing individual morbidity and mortality as well as limiting spread of a highly contagious virus. The results of this study add to the growing body of evidence supporting the potential of our oral norovirus vaccine candidate and addressing a significant unmet public health need, as currently, there is no approved vaccine for norovirus.

I'll also remind you of an additional piece of evidence from our norovirus program that we reported in June 2025, which was the result of a Phase I trial to compare our second-generation vaccine constructs against the original first-generation oral vaccine to see if the new formula induced stronger immunity. As reported, the study shows that the second generation constructs produced significantly higher antibody responses, 141% increase for 1 [ strain ] and 94% increase for the other, compared to the first-generation vaccines. These data help to advance not only our norovirus program, but our oral pill vaccine platform more broadly. The technology underlying our second-generation norovirus constructs has also been incorporated into the other programs in our pipeline. And based on the results of the head-to-head study, we believe that this will increase the immunogenicity of our COVID-19 seasonal and pandemic flu and HPV vaccine candidates.

I'll turn the call over to Dr. Sean Tucker for an update on our norovirus program, including some of our preclinical research activities. Sean?

Thank you, James. We are building a robust body of evidence supporting the potential of our oral norovirus vaccine program and adding to that body of data is a key part of our strategy for advancing our business development efforts around this promising asset. As we have previously discussed, we are positioned to initiate the next clinical trial of our second-generation norovirus vaccine constructs in 2026, pending a partnership or other funding. As part of our evidence generation strategy, we have been exploring how GII.4 construct cross-reacts with and protects against the GII.17 strain of norovirus in preclinical studies. GII.4 typically is the predominant strain underlying the majority of norovirus infection, but there was a significant GII.17 outbreak in late 2024 and continuing into 2025. We have previously shown robust cross-reactivity of our COVID-19 vaccine candidates with multiple SARS-CoV-2 variants, and these preclinical studies are intended to provide insight into the potential utility of our norovirus constructs against additional norovirus strains such as GII.17. The ability to demonstrate this type of cross-reactivity could potentially increase the utility and consequently, the value of our norovirus vaccine program by enabling the use of our current construct to protect against a broader spectrum of norovirus strains. We look forward to sharing the results with these studies with you later in 2026. And if positive, we'll also include them in the data package that underlies our partnership discussions around this potentially first-in-class vaccine. I'll now hand the call over to Jeroen for a brief discussion of our financials. Jeroen?

Thank you, Sean. The details of our fourth quarter and full year 2025 financial results are summarized in today's press release. Revenue for the full year 2025 was $237.3 million compared to $28.7 million for the full year 2024. Revenue in the full year 2025 and full year 2024 were primarily from contracts related to the BARDA contract awarded in June 2024, with 2025 also including revenue recognized from the Dynavax license and collaboration agreement signed in November 2025.

Vaxart ended the fourth quarter with cash, cash equivalents and investments of $63.8 million. Based on current plan, Vaxart expects cash runway into the second quarter of 2027. Vaxart will continue to remain aggressive in seeking strategic partnerships, pursuing other non-dilutive funding options and managing our expenses prudently in order to extend our cash runway.

I will now turn the call back to Steve for closing remarks.

Thank you, Jeroen. And thanks again to all of you for joining us today. We remain very optimistic about the potential of our COVID-19 and norovirus oral vaccine programs to provide important public health benefits while creating value for our shareholders. Our priorities for 2026 are to execute on the data collection and analysis for the COVID-19 clinical trial and to secure a partnership or other funding that will support advancement of our norovirus program. We look forward to sharing top line results from the 400-subject sentinel cohort of the COVID-19 trial early in the second quarter of 2026, and data from the 5,000 subject KP.2 cohort at the end of 2026. As we focus our business development efforts on the norovirus program, we also are continuing to explore potential licensing or partnership opportunities for our earlier-stage assets, including our seasonal and pandemic flu candidates and our HPV program. We believe that our oral pill vaccine platform has potential as a disruptive technology that could address public health challenges and emerging personal preferences regarding vaccination. We are committed to realizing the value of this platform and are pursuing a variety of approaches to achieve this goal for our shareholders and for the many people who would benefit from innovative vaccines that address unmet public and personal health needs.

Before we take your questions, I'd like to remind our listeners that we have a scheduled webcasted fireside chat tomorrow, Friday, March 13, and at 4:30 p.m. Eastern Time. At the fireside chat, we look forward to addressing more of the frequently asked questions we have received from our stockholders. As a reminder, you can submit written questions to [email protected]. We will do our best to answer as many questions as possible at the fireside chat. Since we have the fireside chat tomorrow, we will not take written questions on the call today.

Thanks, everyone, for your time today. Operator, you may open the line for questions.

[Operator Instructions] And our first question comes from the line of Cheng Li with Oppenheimer & Company.

Congrats on the quarter. Maybe 2 from us. So first, it seems like the 400-person sentinel cohort data, there's likely a slight delay. I think the timing is now early second quarter compared to prior guidance on like late first quarter. So curious, like any color you can share on the change?

And also like following question is like, how to frame the expectation now that 400-person sentinel data [indiscernible] through the full Phase IIb data?

Great. Cheng, thanks for the 2 questions. Those 2 questions are definitely appropriate for Dr. Cummings. So James will address them. And yes, just to acknowledge, prior guidance was towards the end of the first year, and now the guidance is early second quarter. And since James has a lot of interactions with BARDA, he can provide some -- a little more detail on the reasons based on your question and the second question as well.

Thanks, Steve. So we'll be reporting the 12-month top line data that we have for the 400 participant cohort. And that's going to include data related to the primary safety end points, and that's why we did that cohort, right? It's a safety cohort. That's why it was designed as well as some initial data on efficacy measures. As I mentioned, that 400-person cohort designed for safety, right? The data from the 5,000-person KP.2 cohort, that will provide some efficacy insights which we expect to report in the fourth quarter of 2026. Any of the discussions we have in terms of releasing data, analyzing data, et cetera, it's made in conjunction with our partners at BARDA. And so they have a say as to what and when gets delivered. So in working with them, that's why I think we see a slight change there. Over.

Great. And James, if you want to take the second question on -- as well in terms of -- and you mentioned this during the comments as well, the potential read-through from the 400 to the approximately 5,000.

Yes. So I was trying to phrase it. The 400-person safety cohort will be or should be some coming in Q2. And then the larger, more robust data set for the 5,000-person KP.2 cohort will give insights along with efficacy insights and safety and immunogenicity. We'll have top line data from that coming at first in -- we project like Q4 of this year with likely immunogenicity results to follow.

Thanks, James. Cheng, any more questions?

I think that's all from my side.

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

So first on the COVID program, now you obviously have multiple parties here, very serious vaccine parties here, BARDA and also Sanofi after a change of control. I was wondering how decision points would be for next steps after you have this sentinel data in 2Q and the larger robust data set in 4Q?

And also just to confirm, you do not have any immunogenicity data as part of this 2Q update? And then I have a quick follow-up.

Great. Mayank. Thanks for the question. So let me address the first part, and then James can talk about what we're going to see in the sentinel 400. So just as a reminder to our listeners, the way that our agreement is set up both with BARDA and Dynavax, a Sanofi company, is that Vaxart and BARDA are responsible for the Phase IIb part of the clinical trial. So this is basically still under our oversight. And then at the end of Phase II, Dynavax would then have the opportunity to decide once the end of Phase II package to the FDA is completed to decide on whether they want to opt-in or not. So I think the good news is we've had, as I mentioned earlier, quite a bit of interactions with Dynavax, and that's going well. And then, of course, we have our interactions with BARDA. And I'll turn it over to James from the comment further on that and then also the -- again, the sentinel 400.

Sure. Thanks Steve, and thanks, Mayank, for the question. So when we're looking at that preliminary top line data, the first thing we'll be able to produce will be the safety, overall look and then also some insights into the efficacy. The immunogenicity data is work that is done right now primarily will be by our partners at BARDA. That takes a little longer to execute. And so that would be following or after we have the initial data tranche, if you will. And that's my expectation, not just for the sentinel 400, but likely for the KP.2 5,000-person cohort as well.

Understood. And then on the norovirus second-gen candidate, has there been any regular input on the endpoint constructs you could be looking to evaluate in this next Phase II study? I guess that's a Sean question or James question.

Yes, I'll take it, Mayank. So we've had discussions with the FDA. As you know, the Phase IIb study, the primary endpoint there is safety, right? So we'll be collecting safety on that as well as immunogenicity, and moving that program forward when -- pending having a partner. Steve, any other comment on that?

Yes. I think that's that right. Not sure, Mayank, if you have sort of a follow-up question. But as James mentioned, right, we have always been interacting with the FDA on our study here.

And with that, ladies and gentlemen, that does conclude the question-and-answer session as well as today's teleconference. We thank you for your participation, and you may now disconnect your lines at this time, and have a wonderful rest of your day.

Greetings, and welcome to the Vaxart Stockholder Fireside Chat Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the webcast over to David Carey, Finn Partners.

Thank you, operator. Good afternoon, and welcome to today's call. Joining us from Vaxart are Steve Lo, Chief Executive Officer; Dr. Sean Tucker, Founder and Chief Scientific Officer; Dr. James F. Cummings, Chief Medical Officer; Jeroen Grasman, Chief Financial Officer; Dr. Ray Stapleton, Chief Technology Officer; and Ed Berg, Senior Vice President and General Counsel.

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, anticipated timing and results of clinical data, any partnerships with third parties, timing of any anticipated regulatory approvals or that any such approval will be obtained, the company's future cash runway, ability to regain compliance with NASDAQ listing standards or raise capital if such listing is regained 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?

Thank you, David, and thank you to all of our stockholders for joining us today for our second fireside chat. We know that many of you listened to our call with analysts surrounding our third quarter update. But before we go to your questions, I'd like to briefly recap recent highlights. Starting with our COVID-19 program, earlier this month, we were excited to announce an exclusive worldwide license and collaboration agreement with Dynavax for our oral COVID-19 vaccine candidate.

Under the terms of the agreement, we can receive cumulative proceeds of up to $700 million in potential milestone fees and equity investment in addition to potential future royalties. This partnership, along with our BARDA-funded Phase IIb contract provides important validation of the attractiveness of our platform and also critical non-dilutive capital, which extends our cash runway into the second quarter of 2027.

We look forward to several important upcoming milestones in 2026 for our Phase IIb program and leveraging Dynavax's deep expertise in vaccine development and commercialization to help advance our oral vaccine candidate. Turning to norovirus, in June, we reported positive Phase I results from our second-generation constructs, demonstrating significantly stronger antibody responses and reinforcing the potential for a first-in-class or best-in-class vaccine.

Norovirus infections cause over $10 billion in annual economic costs in the United States alone, underlining an urgent need for a safe and effective norovirus vaccine. Our unique mucosal protection and oral delivery platform offer significant differentiation to other vaccines in development. As we continue to pursue a partnership through ongoing dialogues, we now anticipate initiating the next clinical trial in 2026 since our time line is dependent on those external discussions and securing the required funding.

Our external discussions are not limited to norovirus, as you saw with our Dynavax agreement. We continue to explore opportunities for both our platform and assets like norovirus, HPV and flu. To recap, we are excited about Vaxart's recent accomplishments like the Dynavax partnership and compelling norovirus data. We are well positioned to demonstrate the strength of our oral pill vaccine platform designed to revolutionize global vaccine protection and delivery. With that, we will now take your questions.

We'll now take questions directly from investors. [Operator Instructions] We've received numerous questions already and prioritize the selection of those that address the most common themes and topics. So our first question is actually from several investors. Why did Vaxart choose Dynavax to partner with for COVID-19? And Steve, I'll turn that one over to you.

Sure, David, and thanks for the question. First of all, we are excited in working with Dynavax. We found a good partnership here because, #1, they're a proven vaccine company. They have taken a vaccine all the way through a Phase III regulatory approval and then commercialization. So that was certainly one of the important reasons. As well, I think there's really a good synergy between the management teams, and we tend to work already well together.

In terms of other factors, I'll also say that this has been a great opportunity for one of our advanced assets. So think about the fact that for our COVID asset, BARDA has funded the Phase IIb trial. And once we get to results at the end of Phase II, should Dynavax want to proceed, we now have someone who is willing to fund a Phase III study, if needed, and then through regulatory approval and commercialization. So for us, we're certainly excited that this is going to be a great partnership.

Next question is from several investors. Are you able to use the funds from Dynavax to pursue other programs? Or is that $25 million fully devoted to COVID development? And then a follow-up from Anil K. Will the cash provided allow you to move forward with noro Phase II? Or will you still need a partner to fund that? And Steve, I'll turn that over to you.

Sure. I'll take the first part of the question, and then I'll hand it over to Jeroen to take the second part of the question. So as a reminder to folks in the audience, the upfront economics on this deal is, #1, a $25 million cash. And then on top of that, a $5 million equity investment that was at a premium to the market price. So we're certainly happy with how that came through. And it is primarily devoted to supporting our COVID program as well as general working capital. It's important that we get to the end of Phase II to provide the opportunity for Dynavax to opt in for the next step. In terms of the other funding, et cetera, let me turn that over to Jeroen.

Yes. Thanks, Steve. So as we're talking to Anil's question, I guess, the $30 million in total that was received here will fund us through the end of Phase II interaction with the FDA following the completion of our COVID study and possibly somewhat beyond. We intend to continue to explore partnerships and other funding options as we're looking at next steps for our noro program. I'll leave it at that and hand it back to you, David.

Next question is from Daniel H. Why has the company told its shareholders for years that Vaxart was working on a partnership for norovirus? You never said anything about the long-term strategy with COVID until we learned of the Dynavax licensing partnership. And I will turn that one over to Ed Berg.

Sure. Thanks, David. As to the question, so we're always looking to move all of our programs forward. And our focus on norovirus was because we were moving our COVID program forward in conjunction with the funding from BARDA and the study was ongoing. When we got the very positive data about our new norovirus construct, there was a lot of interest, and we had discussions with various parties.

And as our discussions proceeded with Dynavax, they ultimately determined that they were interested in our COVID program and taking it forward after the results read out on the Phase IIb study. We're excited about the deal. And we're excited about the fact that we not only receive money now, but of course, we will continue to receive money as -- assuming that they elect to develop this asset. And then finally, with regard to norovirus, as Jeroen said, there are ongoing discussions.

The next question is, it is actually similar. So this is from Steve S. Are there still multiple suitors for noro partnership? And Steve, perhaps you can elaborate on that a little bit more.

Yes. So yes, there continues to be interest in the norovirus asset. Certainly, the announcement of the Dynavax deal has given us a lot of positive attention, which is also very great. So it's increased the focus on not only the assets that we have, but again, a reinforcement of our oral vaccine platform. I'll actually turn it over to Sean because I know Sean has been getting some extra attention as well, if it's fair to say.

Yes, sure. Again, the platform data to date and that we have made several scientific presentations about the clinical data recently, it's been positively received. I'd love to think with my presentation skills, but realistic data -- good data speaks volumes. The recent Dynavax deal and the clinical data we have presented has led to other people reaching out to ask them us how we could partner with them.

And this concludes potential partners who like to say there are novel antigens using our oral vaccine platform. Of course, these discussions are at an early stage, and so there's nothing much to comment. But I think, again, because of the deal, the clinical data and the platform, we're getting a lot of interest lately.

Next question is from several investors as well. Do you have concerns about the trial size that 5,400 patients will be sufficient with FDA? And would you be open to enrolling additional participants? And for this question, I'll turn it over to James.

Thanks, David. With 5,400 or over 5,400 people enrolled in the study, that's 400 in the sentinel cohort and over 5,000 in that main study KP.2 cohort. We believe our trial is sized to produce a robust data set. Based on our statistical calculations, we believe the current trial is sufficiently powered. In fact, having the trial complete enrollment a little on the early side due to the reduced final enrollment number, it will actually enable us to report data earlier, which is a silver lining. We view that positively.

Next question is from Ann N. And she asks, what has the impact of the government shutdown had on BARDA, your conversations with them and funding for the trial? And James, I'll turn that one back over to you.

Thanks, David, and thanks, Ann N., for your question. There's been no significant changes to the Phase IIb trial during the government shutdown. Now that we've completed enrollment, we're focused on generating topline data from both the 400-participant Sentinel cohort and the over 5,000 participant KP.2 cohort. And we've been engaged with our BARDA partners all along the way.

Next question is from Anil K. Why were the low dose chosen for the COVID Phase IIb trial? Do you have any concerns with the mixed IgA results on low dose in the next-gen noro study relative to first-gen high dose and how that may translate to the COVID results. James, I'll turn that back over to you.

Okay. Well, thanks, Anil. So our prior Phase II trial used the first-gen technology. It showed no difference between low and high doses for mucosal IgA and serum neutralizing antibody responses. So we think this will be fine for our second-generation constructs as well. Norovirus, now that's a different indication, and it may require a higher antigen dose than COVID. COVID has infected most people and most of the population has been vaccinated against COVID. Although most adults have been exposed to norovirus in their past, there -- currently, there's no approved norovirus vaccine used in the general population that we could be boosted.

Another question from Anil K. Can we infer anything from the IgA results of noro next-gen trial that could help preview what to expect with COVID? And for this question, I'll turn it over to Sean.

Thanks, Anil K., for your question. Keep in mind, these are different indications and people in the studies have different viral and vaccine exposures. Having said that, the second-gen noro study did show that the new technology can improve immune responses tested, including fecal IgA. While not measured in the noro head-to-head study, our expectation is that the new technology would also improve nasal norovirus IgA as well. If nasal IgA improves with using the second-generation technologies, we also expect more protective responses against the respiratory pathogen like COVID-19.

Next question is from Steven S. Do you still intend to make a concerted effort to reach a partner agreement for norovirus? And if so, what is your goal from a time line perspective? And Steve, I think you've answered that a little bit, but any more color to add there?

Sure. And first, Steven, we certainly want to have a partner agreement for norovirus. In the same light, it's got to be an agreement that is also beneficial to Vaxart. So that's an important aspect of it. And at the same time, as we talk to potential partners, they may have a different time line than us. They may want to see more data, which Sean always -- and Sean and his team are always generating. So again, I would just say that it's difficult to put a time line on that. But in answer to even the prior question, we are having dialogue with potential partners and at this point, it may be difficult for us to give you exact timing just because these folks are on their own time lines.

The next question, this is an online question. It came from Justin W. And he asks, what specific data should shareholders expect in the sentinel Phase IIb topline readout and which endpoints will be most critical for the Dynavax decision point and FDA discussions? And James, could you please answer that one?

Sure. Well, in terms of topline data, we'd like to see some efficacy data to share. We'd also take a look at some of the safety data that might be available. In terms of the Dynavax critical data, I would turn that over to one of the members of our team. I don't want to speak for Dynavax. But I think that this will give us, I think, a very early snapshot as to what we may expect in the larger study.

Yes. In terms of just again, based on our conversations with Dynavax, we get to an end of Phase II. And so the end of Phase II, exactly what James had mentioned, those are part of the decision points that Dynavax will look at as they evaluate what to do next. And I also want to say that certainly in the discussions and prior to completing the agreement, Dynavax to their credit, did a lot of due diligence and evaluated our platform, et cetera. So I think it's also good to say that we have a well-respected reputable vaccine company who has been successful, take the time to evaluate our platform and certainly come out with we should partner with Vaxart. So that's certainly something we see as a positive.

Next question. This is from Karen E. With COVID partnered, would you consider initiating preclinical research on another target? And Sean, I'll turn that one over to you.

Thanks for your question, Karen. Obviously, we continuously review potential candidates for development where there could be a significant need. In addition, given the clinical data that we have achieved to date, we -- as I mentioned before, several people and organizations have reached out and asked us about conducting studies on their antigens where our platform may have a significant advantage. As I mentioned before, again, these are at early stage. But I do want to stress at this point, we are focused on advancing our current pipeline through partnerships and other non-dilutive activities. And we will be very opportunistic, I should say, if additional funding partner opportunities arise. Thanks.

Next question is from Mohamed K. While awaiting a partnership, shouldn't Vaxart independently initiate the FDA Phase IIa clinical trial for its norovirus vaccine with a modest cohort of 80 participants? And James, I'll turn that over to you.

Thanks, Mohamed, for the question. The next step for norovirus will be a trial that continues us on a regulatory pathway to licensure. We continue to engage with potential funding partners and believe that really that's the best path forward.

Here's a follow-up question from Mohamed K. Given the strong preclinical results of Vaxart's avian bird flu oral vaccine candidate, why isn't the company actively pursuing this opportunity to address the recurring and widespread bird flu outbreaks that devastate poultry and cattle populations in the U.S. and globally? And Sean, I'll turn that over to you.

Well, thanks, Mohamed, for the question. Again, we do see this as a major opportunity. But keep in mind, our approach has always been to address human infections through a differentiated drug product, not necessarily protecting animals. Our approach to date has really been -- and again, we want to reemphasize this, is to pursue non-dilutive funding opportunities to move this forward.

Next question is another question from Daniel H. And he asks, have you had any conversations with institutions on why they have been reluctant to invest in Vaxart even when Vaxart was trading on NASDAQ. And Steve, I'll turn that one over to you.

Okay. Thanks, Daniel, for the question. Yes, we still meet regularly with institutional investors. In fact, even recently, they congratulated us on the deal with Dynavax. So there remains interest in our oral vaccine platform. We have heard from numerous investors that they do have internal restrictions on investing in OTC companies. And -- as well, I think what has occurred as we've seen in the third quarter, when we left NASDAQ, we did have institutional support then, but some of these institutional investors had sold out of their position as we see in the third quarter when we went to OTC.

Nevertheless, we always do our best to reach out to all investors, including the institutional shareholders. We keep them updated on our progress. We talk about the platform and our successes. And hopefully, they can change their investment thesis and invest in an OTC company. So we're certainly not going to stop with our external outreach and move forward as such.

I'll just add a little. It's Ed, sorry. At the time that we got the head-to-head new construct data that was very positive, that was unfortunately a time when we were dealing with the potential for delisting and the attempt to gain a reverse stock split. So that -- I'm just speculating, but that may have partially been concern for institutional investors. And of course, we've had more positive news, but we're now on OTC. And while some will -- we hope will certainly find their way to investing in us, we do know that some do have rules against investing in companies not listed on either NASDAQ or NYSE.

And a follow-up from Daniel H. Why has the share price not reacted in any meaningful way from the partnership with Dynavax? Vaxart now trades on OTC, which can limit visibility, but it doesn't hide a company from total sight. OTC has had some very successful companies on it that have chosen to stay on OTC and not be on NASDAQ. So visibility is not an issue for them. Dynavax is owned by institutions such as BlackRock. So institutions are well aware of Vaxart and its potential, yet they are choosing not to invest directly in Vaxart. Why? Ed, I'll turn that one back over to you.

So I talked briefly about it already. Some of them have rules that preclude them. But also, we also know that OTC comes with it less volume and less liquidity, and that is a concern. We can't predict what our share price should be or will be, although we think -- certainly think we're undervalued.

We can just continue to move our science forward and show value, hope that the share price reacts accordingly and the best antidote for no movement of share price is to continue to move forward scientifically. But again, we saw actually some investor theories that OTC would be more favorable for us, and we would actually see a better stock price. And we're -- we share the disappointment of our investors that we really haven't seen that yet.

And another question from Daniel H. Why was the Dynavax licensing partnership not told to NASDAQ during the appeal hearing in August, but instead, Vaxart only told NASDAQ that a reverse split was the only way to get compliance. And Ed, I'll turn this one back over to you.

So first and foremost, of course, we had not signed the licensing partnership at the time we had the hearing. We conveyed all the information we could to the hearing panel. We -- but the hearing panel essentially made the determination that the only way forward was to meet the minimum bid price requirement that we needed to have a plan and that the plan needed to include a reverse split. we were unable to convince our shareholders to vote favorably. And because of that, we were subsequently delisted.

Taking another online question, and this is from Robin A. How replicable is your platform for other vaccines? And I'll turn this one over to Sean.

Yes. I mean, I think that there's -- the more we acquire clinical data on different indications, the better that people understand what the power of the platform is. And I think that the data speaks for itself. I think we've done pretty well in showing that it works for respiratory pathogens in humans. I think we've shown it works pretty well for enteric pathogens in humans. And we're anxious to see if we can move things forward on other indications, for example, bacterial or I would say, oncology targets.

The next question is from Piyush G. And apologies if I mispronounced your name, but are you planning to re-uplist on to NASDAQ? Steve?

Yes. Thanks for the question, Piyush. Our time is better spent on execution of our COVID study, continue to look for partnerships and other non-dilutive capital and the continued research that Sean is talking about there and also continue to work with our manufacturing. So as a reminder, we do our clinical manufacturing here in the United States, and I know that's also important to the government as well. So again, these are some of the key initiatives that we have as a company. And at this point, we're not spending time on trying to figure out how to uplist to NASDAQ. We're really spending time on executing against our corporate strategy and plan here.

And here's a follow-up question from Piyush. And many other investors have also asked the same question. Does Vaxart plan to bring the reverse split back for a vote? Steve?

Yes. So a very similar answer to what I said earlier. At the present time, we're not putting out anything to stockholders about a reverse split. At the present time, we're focused on executing on our corporate strategy, executing on our science and moving our COVID trial forward and also partnering with Dynavax as we continue our ongoing partnership and dialogue.

Next question is from -- another question from Anil K. Have there been any discussions with a partner or BARDA on the flu vaccine given the avian flu preclinical results for the next-gen product? And I'll turn this over to James. James, you may be on mute.

Thanks so much. So in terms of discussions with BARDA, we have continuous discussions regarding our current COVID study with them as well as the platform writ large. So it covers every item really. In terms of other partners for the flu, I'd turn that over to the business team to discuss that piece.

Yes. Thanks, James. From a BARDA perspective, what is positive about our relationship is that we do have a relationship, and BARDA continues to fund the Phase II COVID trial. And I think with that partnership, they are very aware of what we can do on our platform. And as a result, certainly, James, Sean, others on the team, we always take opportunities when we have time to remind them that we have other things going on. Sean, do you want to add to that?

No, I think that because there's been some recent big deals like for Cidara with Merck in terms of the flu assets, novel flu approaches may be something that becomes more exciting in the future. So it's something that we're very interested in, and we'd love to move our platform -- our flu assets forward.

Thanks, everybody. Next question is from Nick S. As Vaxart looks ahead, do you see the company's long-term future more as a fully integrated vaccine developer or as a platform partner enabling larger players to bring products to market? And if it's the latter, how do you see the regulatory and partnership landscape evolving to support platform-based vaccine licensing where once validated, it could accelerate approvals for future candidates? Steve, do you want to take that one?

Sure. Thanks, Nick, for the question. And your question revolves around choice between developing our own assets that we take forward versus being a platform partner where other companies will bring us their antigens to develop. And as Sean was talking about earlier, we received some inquiries around that. And I think the great news for us is we don't have to choose. The answer is both. And this is actually how we've been operating the company.

From a regulatory standpoint, the more advanced we get our lead asset, in this case, the most furthest along is COVID-19, where we get to, hopefully, one day regulatory approval, it gives the FDA some experience with our platform. And frankly, everything that we've been doing with norovirus in terms of discussions with the FDA as well as what we've done in the past, they certainly understand what our platform is about. So that's the positive of having both the platform as well as an asset.

And the business model here also could work in our favor as we partner with companies that have their own antigen, we can certainly receive a piece of the pie in terms of royalties or revenue there. And because of our strong IP position, they don't have a choice but to work with us, especially if they want to move forward an oral vaccine platform. So the answer to your question, Nick, is the answer is both, and that's currently how we're moving things forward.

Next question is from Timothy G. What is the time frame for Dynavax to purchase shares in Vaxart? Jeroen, could you please take that one?

Yes. Thank you for the question. I guess my understanding is that I guess this is around the purchase of the $5 million equity stake associated with the Dynavax transaction. That particular share purchase is completed. It was about 11 million shares. And as we mentioned previously that stock was purchased at a premium over the then current price, clearly limiting the dilutive impact to our current shareholders, which I know is very important to everyone.

Next question is from John L. How will you amplify investor interest in the company and stock over the next 6 months? Steve?

Yes. Thanks, John, for the question. Like we've done in the past, we continue to participate in investor conferences. For now, we're still getting those invites, and we meet regularly with current investors as well as hopefully prospective future investors. So there are upcoming events in 2026. For those of you who are familiar with the life science space, January is also the JPMorgan conference. And I can say that schedules are filling up already.

So I think we're happy that we continue to have opportunities to meet with investors. At the same time, we will continue to keep the Street informed on any material updates. And as always, we'll continue to have results announcements, these fireside chats. And then I would say at the end, our hope is to continue to be allowed and also invited to these types of life science conferences. Again, for now, on OTC, we have been invited to quite a few, but hopefully, we don't drop off their invite list because we're not on NASDAQ.

And the next question comes from Keith O. and Steve, you actually answered a little bit of this question, but will Vaxart commit to more fireside chats with a regular cadence? And what would that frequency most likely be? Jeroen, do you want to take this one?

Sure. Yes. So I think it's -- as you recall, I guess, the most recent interaction was in August where we had a fireside chat, and we committed at the time to provide regular updates. I think in this section, sort of following the quarterly earnings call seems like a pretty reasonable cadence for us to follow on a quarterly basis after the earnings announcement and hear from our investors how they perceive the data and what questions are on their minds. So while I don't want to provide a firm commitment per se, I think this sort of quarterly schedule is probably directionally where we would like to go and provide this opportunity and have this interaction with everyone.

The next question is from Diane H. Would a Phase III against the placebo be able to run concurrently with the observation of the 5,000-person Phase IIb trial in hopes of a product for the 2026 season. If not, why? And James, I'll turn that one over to you.

Thanks, David, and thanks, Diane. We would wait until the end of the Phase IIb trial when we have that data package to have an end of Phase II meeting with the FDA. That meeting will then help inform us of some of the particulars of what that Phase III trial would look like.

Next question is from Matthew S. Recent discussions around the COVID-19 vaccine trial suggest potential signals that the oral platform may have therapeutic benefit for long COVID. Can management clarify whether this finding is being formally evaluated and whether a long COVID program is something you intend to pursue independently or potentially in collaboration with Dynavax. And I'll turn this one over to Sean.

Yes, it's a very good question. Thanks for asking. But right now, we are focused on the current study and comparing our oral vaccine candidate against mRNA comparator. We are not pursuing right now a treatment per se for long COVID, but it's possible that some of the read-through results on the trial may provide some guidance. We'll see.

Next question is from Sunny S. and actually several other investors who have provided this question in the online chat. Why is Vaxart not investigating stock manipulation like from short sellers? Ed, could you take this one?

Sure. So as we mentioned in the last fireside chat, if anyone had information that would help us either investigate or refer an investigation to a regulatory authority, we would encourage them to bring it forward. We -- I have talked to, and the company has talked to law firms and investigators about this issue. And at least at the current time, we don't have any information that would lead us to either refer or further investigate, but we're always interested in that information being provided to us if, in fact, there is something to investigate. So thank you.

The next question -- another question from Mohamed K. Why does Vaxart continue maintaining a high monthly burn rate to operate its in-house manufacturing facility, particularly now that Dynavax is responsible for COVID-19 vaccine production? And Jeroen, could you please take this question?

Sure. And thank you, Mohamed. It's a great question. So the ability to perform this in-house manufacturing is really essential and has been essential to secure these partnerships with Dynavax and previously with BARDA on the COVID program. Specific to that BARDA program, so our proprietary in-house manufacturing process has enabled us to quickly deliver these clinical lots of the new strains in the program, switching from the XBB strain in that initial 400-person sentinel cohort to then the KP.2 strain in the main cohort following that.

These manufacturing facilities are located right here in South San Francisco and provides a very important differentiator for our company. And as Steve mentioned, it's important for our sort of administration here as well to have that local U.S.-based. As to the cost burn rate, we have reduced our staffing as we announced in Q1 and Q2 of this year, and we've streamlined our cost structure in 2025 while maintaining these critical differentiating capabilities here in manufacturing.

The next question is from Teresa. How has your financing strategy changed following this partnership? And Jeroen, I'll turn this one back over to you.

Yes. Thank you. So we're pleased that the Dynavax partnership and our cost management focus that I just commented on enabled sort of this extension of our cash runway into the second quarter of 2027. We'll remain aggressively seeking strategic partnership and other funding options to allow us to invest in advancing our pipeline programs, including noro and continue to focus on extending our cash runway as well. As an alternative and clearly based on favorable market conditions, we'll consider traditional equity financing options while continuing to focus on managing our expenses very prudently.

Next question is from William C. Given the situation at HHS with some employee movement at the senior levels, how has it impacted your partnership with BARDA? Ed, could you please take that one?

Sure. So we have always had a good relationship with BARDA. We are working closely with them on the study. We meet with them regularly, and we have had very productive interactions throughout the time, including even in light of the stop work orders, and we appreciate their support and their funding. And we're looking forward to finishing up the study and seeing the readout eventually.

Next question is from Allen P. When would be the next milestone from Dynavax and what's the timing? Steve, could you take that one, please?

Yes. Thanks, Allen, for the question. The next milestone will essentially follow the results of our Phase IIb topline data, as we had mentioned earlier. Upon seeing that data, if Dynavax opts in or elects to move forward, then Vaxart is eligible to receive an additional $50 million as a milestone payment. And then as I mentioned earlier, there'll be sales milestones, royalties, et cetera. So clearly, we're all focused on the same thing, which is execution on our Phase IIb trial, which I want to just acknowledge and thank our clinical operations team as well as the subjects that are in the trial as well as our clinical trial sites for all their hard work.

Next question is from Ellen R. And her question is, what is the latest on your flu and HPV programs? Sean, could you please answer this?

Sure. Thanks for the question. As I mentioned before, we do want to advance our avian flu program, and we're doing so. As a reminder, we did -- our new avian influenza vaccine was 100% protective against death in a really strong, robust ferret challenge model against the clade 2.3.4.4b, what's certainly in circulation, and that compared favorably to placebos where 0% of the animals were able to survive it.

Our plan right now is to publish those results in a peer reviewed forum. And again, we'll be opportunistic, and we'll be glad to move that forward with the right partner. As far as HPV, we are continuing to explore other partnerships and funding opportunities because we certainly believe in that program, and we'd love to move it forward.

Next question is from Nick S. Do you believe that by the end of 2026, there will be enough clinical data to validate the oral delivery technology and potentially trigger a faster pace of partnership or licensing activity? Steve, could you please take this one?

Yes. Thanks, Nick. 2026 is going to be yet another important year for the company. I think we're proud on the fact that we are getting to some important clinical milestones in 2026 and especially as it relates to the COVID trial, but that also is additional data on the oral vaccine delivery platform because now, as James had mentioned, we have 5,400 or so subjects that are part of a clinical trial. So from our standpoint, yes, absolutely, by the end of 2026, we should have some interesting clinical data to help validate the technology.

On top of that, as we get into further discussions with potential partners, the common ask is show us more data. And so we have the opportunity to show more data. Sean and his team continue to work hard in generating preclinical data, et cetera. So yes, absolutely. We're all looking forward to 2026. But 2025 is not done yet as well. So we continue to work hard towards the end of the year.

Next is an online question from Vick S. How supportive is the U.S. government and BARDA right at this time? And Steve, could you take this one, please?

Yes. Thanks. We've had lots of conversations, whether it's in person, whether it's on virtual meetings, et cetera. And the best evidence of the current support is the fact that we have been allowed to continue on this Project NextGen COVID-19 clinical trial and the fact that the subjects are being followed, and James and his team continue to have quite a few interactions. And so from our standpoint, we feel very happy that we have a good working relationship with BARDA.

Next question, another online question from Andre R. Has Vaxart been in contact with potential partners in Europe, the Gates Foundation, Samsung Biologics and Gavi with regards to the norovirus asset? Or is Vaxart's primary focus on potential partners in the U.S. And Steve, I'll turn this one over to you.

Sure. Again, thanks. Good question. I can say that Sean, James and I have been at places like the World Vaccine Congress and the world will tell you that it's not the U.S. Vaccine Congress. And I think in that regard, many of the entities that you have mentioned there are certainly aware of what we do. based on the history of Vaxart and even discussions that have occurred for quite some time. So that is a group that we look at. I also want to say that when we have partnership discussions, it's not limited to U.S.-based companies.

We speak to multinational global companies on top of the U.S. companies. And certainly, Dynavax is a U.S. company that we're happy to be working with. But we also speak to regional players. And so these are smaller companies that have a certain geography outside the United States. And so from our standpoint, we look at the fact that this vaccine platform should be available to anybody in this world. And also, Sean, if you want to just highlight our prior good working relationship with the Gates Foundation just for few seconds, if you like...

Yes. I think, again, we did have a partnership with the Gates Foundation. I think it went really well. We were able to prove something that was an open scientific question, and it helped us move our norovirus program forward. And again, depending on everybody's priorities, there is a possibility that we will continue doing something similar with what I would call NGOs or a pharma partners.

Next question comes from [indiscernible] B. And Sean, if you could please take this one. Does Vaxart retain the right to develop the S and N constructs?

That's a good question. My understanding from the Dynavax deal is that they are taking over our COVID assets as we go forward, and it's up to them to decide whether they want to expand the antigen choice. Right now are -- in clinic, we're pursuing the S approach because that was deemed better from the standpoint of producing better antibody responses than the S plus N.

Okay. And at this point, I'm going to turn the call back over to Steve for any closing remarks.

Great. Thank you, David. Thanks for all the questions today. I want to just take a moment to thank all of our stockholders for your continued engagement. Before I make a few closing remarks, since we get towards the end of the year, I also want to take a moment to acknowledge all the hard-working employees here at Vaxart. I'm proud and on behalf of the management team, we're proud to be working with them and the whole entire management team, we talk about what's happening, but it's also our hard-working employees that are on our teams that make all of this happen.

So I want to once again thank them for their hard work because they work through a tough year where there's been a lot of noise. Also, as Jeroen mentioned, there is fewer of us employees as well. And so a lot of folks have taken on additional work. So thanks to them. And then in closing, I want to just sincerely thank our stockholders for their continued support. We look forward to continuing to engage with you through fireside chats in 2026. We remain fully committed to providing transparent and timely updates regarding the company's strategic progress and key developments. And I wish you all a good rest of the year. Operator, you may close the call.

Thank you. That concludes today's conference. All parties may disconnect.

Greetings, and welcome to the Vaxart Business Update and Third 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 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 program developments. Jeroen will then share an update of our financials. And finally, I will have some closing comments before we open the call for your questions. Starting with our COVID-19 clinical program. Last week, we were excited to announce an important value-creating partnership with Dynavax, a commercial stage biopharmaceutical company that has a proven track record in commercializing innovative vaccines.

As part of the agreement, Vaxart could potentially receive up to $700 million in total license, regulatory and milestone fees as well as royalties for our oral COVID-19 vaccine candidate. This is a major milestone for the company and this program, which validates the potential of our platform and will provide critical nondilutive capital that will help us advance this program forward. Here are some of the important terms of the agreement. Dynavax will pay Vaxart an upfront license fee of $25 million and make a $5 million equity investment in Vaxart at a per share price premium to market pursuant to the terms of the securities purchase agreement.

Combined with our current cash position, our cash runway now extends into the second quarter of 2027. Dynavax will receive an exclusive worldwide license to develop and commercialize oral COVID-19 vaccines based on Vaxart's delivery platform. Vaxart will retain full operational and financial responsibility for the oral COVID-19 vaccine program through the completion of the ongoing Phase IIb clinical trial and the subsequent end of Phase II meeting with the FDA. In addition, after receiving the results of the Phase IIb clinical trial, Dynavax will pay an additional fee of $50 million to Vaxart if Dynavax elects to assume responsibility for continued clinical development of the oral COVID-19 vaccine program.

Finally, if Dynavax elects to assume responsibility for the continued development of the oral COVID-19 program, Vaxart may be entitled to receive up to $195 million in potential future regulatory milestone payments, up to $425 million in potential future net sales milestone payments and tiered royalties at rates in the low to mid-teens on potential future net sales of our oral COVID-19 vaccines. We believe this collaboration is extremely important for Vaxart as a company. It not only extends our cash runway, but it speaks to the potential of our oral vaccine platform, which could be a major differentiator versus other vaccine delivery methods.

Later on, James will highlight details of our Phase IIb progress, but we remain on track to announce multiple datasets in 2026. We appreciate Dynavax's view that COVID-19 remains prevalent in society as infections, hospitalizations and even death persist and that the new solutions are in order. At the present time, there are very few deals in the vaccine space, and we appreciate Dynavax's investment and expertise, which can assist in moving this project forward to approval. Partnering with Dynavax will also allow Vaxart to become better positioned for late-stage development on other indications. To reiterate, this is a major step forward for the company.

We also appreciate that Dynavax shares our view that our innovative approach could potentially transform global public health and revolutionize distribution and administration. We look forward to sharing updates on our progress and collaboration in the future. Turning to our norovirus program. As we previously shared, we were pleased to report positive Phase I top line results from our second-generation constructs, which demonstrated this vaccine technology produced much stronger antibody responses compared to our first-generation constructs.

Since this positive top line data update, we have presented at multiple medical conferences, highlighting the statistically significant increases in GI.1 and GII.4 norovirus blocking antibodies as well as other analyses from the study, which underscores the potential for protection that the new constructs provide. Sean will share more details of our compelling norovirus data shortly. Norovirus continues to be a leading cause of acute gastroenteritis worldwide, causing significant morbidity and mortality in countries of all income levels, particularly amongst young children and older adults.

At an economic cost of more than $10 billion in the United States alone, there remains an urgent need for a safe and effective norovirus vaccine. We believe that our norovirus vaccine candidate 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. We remain eager to advance this program and continue to dialogue with several interested parties since our last update.

While we are committed to securing our partnership, please understand that these discussions are predicated on other parties' time lines, not just ours. As a result, we now anticipate initiating the next clinical trial in 2026, provided that we receive funding. To recap, with multiple programs, we look forward to further demonstrating the strength of our oral vaccine program. Now with a partner in Dynavax, we can further advance our COVID-19 program, pending 2 potentially robust data readouts in 2026.

With a platform designed to generate both systemic and mucosal immunity, 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 Dr. Cummings for a review of our COVID-19 clinical program. James?

Thanks, Steve, and thanks to everyone joining today's call. As Steve has discussed, we've made significant progress with our COVID-19 oral pill vaccine candidate on the business development front with the signing of an exclusive license agreement with Dynavax. We also continue to make important progress in the clinical development of this asset. As we announced in August, we did receive a stop work order from BARDA on our Phase IIb clinical study comparing our COVID-19 oral pill vaccine to a commercially available mRNA injectable vaccine.

This order stopped enrollment, but allowed us to continue work associated with the per protocol follow-up of subjects who had already received a vaccine. In October, we announced that BARDA will continue to provide funding for follow-up for the approximately 5,400 enrolled subjects, consisting of 400 subjects in the sentinel cohort and approximately 5,000 subjects in the KP.2 cohort enrolled in the trial. We believe that the trial data from the enrolled participants will provide useful insights and a strong foundation of evidence that could potentially advance our COVID program.

As a reminder, the primary endpoint of this study is the relative efficacy of our oral pill vaccine compared with the mRNA vaccine for 12 months post vaccination. The trial will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction and adverse events in each cohort. We remain on track to report 12-month top line data from the 400-participant sentinel cohort in the first quarter of 2026 and to report 12-month top line data for all participants in the fourth quarter of 2026.

In addition to potentially advancing our COVID-19 program, we believe the results of this trial also support our oral pill vaccine platform technology and inform development of our additional pipeline assets. I'll turn the call over to Dr. Sean Tucker for an update on those assets. Sean?

Thank you, James. In the third quarter, we presented additional Phase I data supporting the potential efficacy of our second-generation norovirus oral pill vaccine candidate at the Ninth International Calicivirus Conference. The data showed a 25-fold increase in the GII.4 fecal IgA response and a tenfold increase in the GI.1 fecal IgA response over baseline with a high dose of the second-generation vaccine candidates after a single tablet administration for each strain.

The data also showed an eightfold increase in the GII.4 fecal IgA response and a sevenfold increase in the GI.1 fecal IgA response over baseline with a low dose of the second-generation vaccine candidates after a single tablet administration for each strain. While the Phase I study was not powered to determine superiority by statistical methods, the fecal IgA increases observed with the second-generation constructs at the high dose compared favorably to the increases observed with the first-generation constructs at the same high dose level.

As a reminder, results from the Phase II challenge study of our first-generation constructs identified fecal IgA as a critical correlate to protection from norovirus infection. The positive fecal IgA results observed with our second-generation construct, combined with the previously announced serum responses strongly suggests that the second-generation constructs induce much more robust immunological responses than our first-generation constructs. We believe this has the potential to translate into improved protection for our second-generation constructs.

As previously discussed, this program is ready to advance to the next clinical study pending a partnership or other funding. With the successful completion of our partnership with Dynavax for our COVID-19 program, norovirus remains a highly attractive opportunity, and we continue to focus on securing resources to advance our second-generation norovirus program. We are updating our guidance for the potential timing of the next clinical trial to start in 2026. I'll now hand the call over to Jeroen for a brief discussion of our financials. Jeroen?

Thank you, Sean. The details of our third quarter 2025 financial results are summarized in today's press release. Revenue for the third quarter of 2025 was $72.4 million compared to $6.4 million (sic) [ $4.9 million ] for the third quarter of 2024. Revenue in the third quarter of 2025 was primarily from the BARDA contract awarded in June 2024. Revenue in the third quarter of 2024 was primarily from a separate BARDA contract awarded in January of 2024. Vaxart ended the third quarter with cash, cash equivalents and investments of $28.8 million.

Based on our current plan, which includes proceeds from our license agreement with Dynavax received after the quarter close, Vaxart expects cash runway into the second quarter of 2027. Vaxart will continue to remain aggressive in seeking strategic partnerships, pursuing other nondilutive funding options and managing our expenses prudently in order to extend our cash runway. I will now turn the call back to Steve for closing remarks.

Thank you, Jeroen. To recap, everyone here at Vaxart is excited about the collaboration agreement with Dynavax for our COVID-19 program. The support from Dynavax and their late-stage expertise will be instrumental as we advance this program. Moreover, this partnership further validates our oral vaccine platform, underscoring its potential in transforming global public health. We look forward to sharing multiple data readouts from our COVID Phase IIb trial in 2026. Our pipeline of norovirus, flu and HPV assets, which are backed by promising preclinical and clinical data demonstrate the broad value of our oral vaccine platform.

We remain actively engaged with many interested parties about partnership opportunities for each of these programs, and we'll share updates on developments as they become available. Before we take your questions, I would like to remind our listeners that we have a scheduled webcasted fireside chat on Tuesday, November 18, at 4:30 p.m. Eastern Time. At the fireside chat, we look forward to addressing more of the frequently asked questions we have received from our stockholders. As a reminder, you can submit written questions to [email protected].

We will do our best to answer as many questions as possible at the fireside chat. Since we have the fireside chat next Tuesday, we will not take written questions on the call today. Thanks, everyone, for your time today. Operator, you may open up the line for questions.

[Operator Instructions] Our first question is from Cheng Li with Oppenheimer.

Congratulations on the progress and the collaboration with Dynavax. Maybe 2 questions from us. First, can you maybe talk about why Dynavax decided to reach a deal now instead of maybe waiting for a few months for -- to see the data from the sentinel cohort in early '26? And also like can you provide some color on the data they saw before maybe reaching the deal? And I have a follow-up question.

Great. Cheng, thanks for the question. Yes. So first of all, we're, of course, very excited to have our partnership with Dynavax. And in terms of just what they looked at, right, I think at the high level, first is the science in the platform. And I think there was a lot of discussions around what the platform can offer, right, and all the things we've talked about in terms of the oral delivery, the mucosal immunity, et cetera. And then on top of that, right, I think this was a good time for both companies even before the data came out because of the good fit between the companies, right?

We're really happy to have a proven vaccine company that has been able to take a product through FDA approval as well as through commercialization. And I think it just worked out really well from a timing standpoint, and we're delighted to have them on board. In terms of the data that they would have seen, and James can certainly comment on this, we're blinded to the clinical data. But as well, in any partnership deal, there is quite a bit of due diligence.

And so we're actually pleased that they did take their time, go through the diligence and in the end, felt very comfortable with moving forward with the deal. James, if you want to just comment or reiterate on the fact that certainly in the clinical trial, we're blinded, I'll let you comment more on that.

Thanks, Steve. So from the clinical trial currently ongoing, we are -- it's a double-blinded trial. So both ourselves as well as the participants are unaware of which product they may have received, and we continue to collect data on them. The sentinel cohort will have top line data available in Q1 of 2026. The larger KP.2 cohort, which is approximately 5,000 individuals will have top line data available when that study is concluded during its 12-month follow-up, and that would put us in Q4 of 2026. Until that time, because we are double blinded, we can't comment on further on the study over.

Got it. That's helpful. And I guess just another question is with the additional funding like upfront payments from Dynavax. Can you maybe talk about your thinking about the norovirus program, whether you can maybe start the Phase IIb trial by yourself? If not, what kind of the pipeline priority you are thinking with the additional funding?

Yes. Thanks, Cheng, for the question. I think overall, we're, number one, excited that we have the validation from a proven vaccine company that our technology has good utilization in the marketplace. And certainly for a COVID vaccine candidate, right, they share -- Dynavax shares in our same view about this still being a good opportunity in the marketplace. In terms of our other assets, whether it's HPV, norovirus, even flu, it's created some opportunities for us to really have ongoing dialogue with potential partners on any of these assets.

So the priority is still the same, which is including norovirus, being able to have productive conversations with anyone who is interested in partnering with us. On top of that, Sean, who's sitting right here, I think he can also attest to the fact that with the validation of the platform, I think there's also folks who may be interested in providing us their antigen to our platform. Sean, if you want to comment more on that.

Sure. Yes. I think that given the strength of our clinical data and of course, with this recent validation by our friends across the bay at Dynavax, there's been a lot of interest coming up about using some novel antigens with our system. And of course, these possible collaborations are still at a very early stage, but we remain committed on the current pipeline. But if something comes along, we're very excited about moving it forward.

Our next question is from Roger Song with Jefferies.

This is Nabeel on for Roger. Just maybe a couple from us. How do you think about this year's COVID season and -- in comparison with last year and kind of the market potential for something that is again oral? And how do you also think about your product's strain -- ability to respond to strain change as we've seen also not just in COVID, but previously in norovirus?

Great. Nabeel, thanks for the question. Yes, I'll make some general comments about the market. And I think the best person to talk about strains and being able to respond to that is going to be James. But I'll just make an additional comment just on our manufacturing. So I think the audience knows that we do our clinical manufacturing right here in South San Francisco. And for the COVID trial, we were pretty pleased to be able to produce not only just for the XBB strain but also for the KP.2 strain.

So as a company, we think we were pretty versatile in being able to manufacture something for a strain in a very timely manner. I think you've seen as well, just to your first question around the COVID marketplace, right, and it's still a sizable market. Certainly, there are less folks who are taking the COVID shots now. It could be attributed to what's happening in the press. It could be attributed to their perceived side effects. It could be just perceived on the fact that it's a bit of a hassle to schedule an appointment, go to the pharmacy, get the shot.

And from our standpoint, we offer a lot of advantages as well as alternatives to that. So I think from our standpoint, and Dynavax certainly evaluated as well that there is still a good market opportunity as it relates to COVID. I'll turn it over to James. James, if you want to comment a bit just on strains and so forth.

Thanks, Steve, and thanks for the question. So I think 2 things. One, in terms of strain changes, what we've shown earlier in our development of this product is that we have the ability for cross-reactivity, not just for the strain of interest, the strain that was developed for this product, but also across newly developing strains. And so the benefit of this -- one of the benefits of this protocol is that we're looking at efficacy over an up to 12-month period.

And during that time, not only taking a look at was someone ill or infected with the virus and/or symptomatically ill, but also taking a look at what the potential strains may be. As we know, the coronaviruses do have an ability to adapt and to shift or strain change. And so we would expect over the course of a 12-month period that we'll see more than likely one strain circulating certainly in the United States, but really across the globe. And -- so that's some of the data that we'll be taking a look at as part of this study.

One other thing I -- one other thing I'd like to add on, and this is one of the -- again, one of the key things about that we demonstrated in a nice animal model is we showed that our vaccine in producing these mucosal responses, it could impact the ability of the virus to be transmitted to others. So it may have a better overall health benefit. And certainly, this kind of -- this platform makes it, because it's oral pill, much more differentiated than other things that are out there.

Thank you. This concludes our question-and-answer session. We want to thank you again for your participation today. You may disconnect your lines. This concludes our call.