Vaxart, Inc. Aktie

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.

Greetings, and welcome to the Vaxart Stockholder Fireside Chat Conference Call. A question-and-answer session will follow management's opening remarks. Individual investors may submit relevant questions to [email protected]. As a reminder, this conference is being recorded. I would now like to turn the webcast over to David Carey, Finn Partners.

Thanks, Diego. 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 as 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 in other periodic reports filed with the SEC. Vaxart undertakes no obligation to update any forward-looking statements after the date of this call.

Further, please note that Vaxart has filed a definitive proxy statement with the SEC relating to the proposed reverse stock split and related reduction in authorized shares of common stock. The company and its directors, executive officers and certain employees and other persons may be deemed to be participants in the solicitation of proxies from the company's stockholders in connection with the business to be conducted at the special meeting.

Please read the definitive proxy statement and the other relevant documents filed with the SEC as these contain important information about Vaxart and the proposals to be voted on at the upcoming special meeting of stockholders. These documents can be obtained free of charge from the SEC at sec.gov. I'll now turn the call over to Steve Lo. Steve?

Thank you, David, and thank you to all of our stockholders for joining us for this important discussion. We're here today to talk about the upcoming special meeting and the reverse stock split. Our goal is to provide clear and direct rationale for this proposal and to address the questions you had about our business and our corporate strategy. There are also a number of misconceptions about our company that we hope to clarify.

Many of our listeners today are invested in Vaxart because you share in our vision of developing and one day bringing to market our unique oral pill vaccine candidates, which may have significant benefits over current needle vaccines. Vaxart's Board of Directors and management team are deeply committed to proving our science to the point where we can launch a safe and effective commercial product or partner with another company to do so, all to maximize the full value of your investment. We will continue to work tirelessly to fulfill that objective.

Make no mistake, we are tied to the success of Vaxart. Our interests are aligned with yours. Listing on NASDAQ not only helps us advance our science, but it also helps better protect your investment. If we were truly out for ourselves, we would stay on OTC where oversight and compliance rules are less stringent, but that is simply not the case. NASDAQ isn't just better for the company, it's also better for stockholders. Drug development is a long and expensive process. Listing on NASDAQ gives us a better chance to move our programs forward with support from institutional investors or partnerships, and we are actively pursuing both.

But to get there, we need your continued support. Remember what we are trying to accomplish. It is about transforming global public health. We are trying to do what no other company has done, develop a pill that can be taken instead of a needle vaccine for a variety of infections, including norovirus, COVID and avian flu. We are now at a major crossroads, not just to unlock our platform's potential, but to maximize the value of your investment.

In addition, not being listed on NASDAQ could affect our viability as a business. This is why a NASDAQ listing is more than just a preference. It is a foundational action that we believe is critical to our long-term success. Simply put, remaining on OTC could negatively impact our business.

Both ISS and Glass Lewis, 2 of the leading independent proxy advisory firms, have recommended that stockholders support the reverse stock split proposal. For all these reasons, we strongly believe that a vote for the proposal is in the best interest of Vaxart and you, our stockholders.

Let me add that we appreciate our loyal stockholders, sticking with us through thick and thin throughout our whole entire journey. We understand that a reverse stock split could result in stock volatility. However, we have several important upcoming milestones, including potential partnerships and data readouts. We believe all of these inflection points will mitigate downside risk in the long term and respectfully ask that you grant us the best opportunity to achieve these. With that, we will now take your questions.

Thanks, Steve. So we'll take questions directly from investors. And as a reminder, participants may submit questions through the webcast portal or you can e-mail them to [email protected]. And we will do our best to answer as many questions during this hour-long fireside chat.

So the first question, Vaxart team, this is from several investors actually. Why does Vaxart continue to remain so intent on gaining stockholder approval of the reverse stock split proposal even after stockholders previously voted it down, Jeroen, do you want to start?

Sure. Let me go ahead and take this one. Thank you, and thanks to everyone for your questions here and your engagement here. This question is really at the heart of why we're meeting today, so I'm glad it came up. So listing on the NASDAQ relative to the OTC market provides a number of key benefits. So when I'm looking sort of at top of mind some things like increased visibility. So listing on the NASDAQ is a national exchange, provides much broader visibility to our company and the stock. And more specifically, when we're looking at things like analyst coverage, right?

We're covered, as you all know, by Jefferies, Oppenheimer and B. Riley, sort of brand name investment banks that provide regular updates and communication from an independent perspective on our science and our advancements as a company. This coverage may not continue if we continue to trade on the OTC.

Another thing I'm thinking about is our liquidity. So being in a highly liquid stock really is important for investors, right? Low liquidity makes people very nervous because you cannot get in and out of this stock readily. It's much more expensive to trade, right? There's larger bid-ask spreads when you're looking at, say, an OTC market versus a NASDAQ. So what has happened to our liquidity more recently.

So trading volume is down by about 1/3. When we look at 2024 versus 2025, sort of this most recent time frame, mid-July to mid-August, we're trading about 1.5 million shares per day in 2024, and now we're below 1 million a day in 2025. And both of these factors sort of translate then into access to capital. So we have broader visibility and higher liquidity on NASDAQ, which would allow us broader access to capital markets and negotiate the best possible financial terms for us as a company to raise additional funding, benefiting you as an investor with a less dilutive option.

So things like high discounts, warrant coverage may come up on the OTC, but we may be able to avoid or at least get far better terms when trading on the NASDAQ. And finally, there's the element of sort of oversight. So NASDAQ provides much stricter requirements on corporate governance, financial reporting disclosures. And so that protects you as an investor and make sure your investment is secured.

So also, I'll jump in. It's Ed. The other thing that we were looking at when we were comparing OTC to NASDAQ is the range of ways we could raise money. We know we can raise money in a nondilutive manner if we get a government grant or an award, and we've done that, and we're going to continue to do that. But we also know that a partnership might provide us with funds. But when we look at other ways for investors to participate, what we find is actually that NASDAQ is more advantageous. There are more ways to move forward with investment -- to raise money with investors.

And the reason for that is because if NASDAQ as a listing is preempted from what are called Blue Sky laws. Those are state laws, state by state. And if we're on OTC, we have to go state by state to determine whether investors can participate in a fundraising. And we have been looking at some fundraising vehicles that are either less dilutive or allow shareholders to participate. So on the less dilutive ATMs come to mind because of the way they can operate and are careful to not -- to do purchases over time or issue stock over time.

And on the rights offering, it would be participation possibly even by shareholders, we're looking at that. And as we look at it, it's clear that Blue Sky laws are going to keep us from easily putting those type of offerings together. And so we think NASDAQ is a much better vehicle for having a full range of investment options.

Yes. Before we get to the next question, I'll just say that our goal is we want to get to the point, as we mentioned earlier, that we want to commercialize or find a partner to commercialize this vaccine and -- or our vaccine platform. And companies early stage in vaccine development, I'm aware of a few that also had to do a reverse stock split, but now they're billion-dollar companies with sales, right? Novavax and Dynavax come to mind who actually had a reverse stock split early in their clinical development. So great first question. We'll turn it back to David for the next one.

Okay. Thanks, Steve. This next question is from Jeff G. What was Vaxart's plan to regain compliance that they presented to the NASDAQ Hearings Panel? When do you expect to hear back from the panel?

Yes. So our panel, just for our listeners, we actually had the hearing last week on August 14. We presented a very compelling case, first of all, about our company, and we talked about our science as well as hopefully some potential partnerships. So we highlighted our business and really had a chance to share with them why we think we have great opportunity as a company.

In terms of the meeting, we thought it was productive that the panel certainly heard our plan, but we may not hear back for about 2 or 4 weeks based on what they told us. Ed, I'm not sure if you want to add anything else since you were also part of the process.

So a couple of things. It was clear after we work with our expert advisers who do this for a living, essentially come before NASDAQ that the only way forward is to present a plan for compliance. There was no way to get some kind of dispensation to -- based on unusual circumstances. We presented our plan, the only plan we presented was going back to our stockholders and asking for approval of the proxy to affect the reverse split. There were no other presentations. And we could hear any time. And I do want to say when we hear, we will let our stockholders know because we are obligated to disclose material information. And this is material information.

Yes. And their goal for us is that for all NASDAQ companies is to trade above $1. And certainly, if we get there organically, we're fine, but they also want to see what your plan is if you don't. And this is what Ed was referring to. Great.

Okay. Next question is from Travis. Why is this proposed -- sorry, why is this proposal considered routine? Who decides that? How does broker voting work on routine versus nonroutine proxy matters? Ed, I'll throw this one over to you.

Sure. So when we put together a proxy, we actually go to the New York Stock Exchange, which oversees brokers and voting. And we are not given any chance to make a determination or otherwise even petition for whether it should be a routine versus nonroutine matter. The New York Stock Exchange makes that decision, again, because they're overseeing broker voting. So the way your broker votes is set by this exchange.

They have, with regard to reverse splits, determined that they are a routine matter. Again, we didn't have any say. And if you look at other companies that have affected reverse splits and you look at their proxy, it will also be categorized as routine.

Okay. Thank you. Next question is from Paul B. Does insider ownership reflect adequate alignment with stockholders? Are insider shares treated equally with all other stockholders in the event of a reverse stock split. Steve?

Yes. So insider shares, the ones we own, the ones that are issued from the employee stock purchase plan, options, all those are also subject to the reverse stock split. So they're all essentially treated the same. And I want to also just be genuine and honest. I mean we've also suffered losses as well as the management team for owning the stock. So if anyone is -- has any incentive, right, it's the entire management team that we really want our company to succeed.

I also want to say that for the last 4-plus years, none of the executives have sold their shares outside of a requirement from taxes -- to cover taxes from RSUs. And so we really do participate and share in hopefully, the rewards 1 day as well. Board members have purchased shares recently. I have as well.

Yes. And of course, I've been invested in Vaxart for many years. And like you, the shareholders, price was higher when we bought than it is now. And again, so from our standpoint, we're definitely in alignment with the shareholders.

Thanks, Sean. That's a good point that you make there as well.

Okay, thank you. Next question is from David W and also asked by Anil K. Are the approved equity incentive plan and employee stock purchase program shares proportionally reduced if the reverse split passes? Why are the preferred shares not included in the reverse split proposal? Ed, do you want to take that one?

Sure. So the first part of the question, insider shares, including the equity incentive program shares and the employee stock purchase program shares will be proportionately reduced. The reason we didn't also reduce preferred shares is really there are a few reasons. We haven't used them. We don't have a current plan to use them, so we're preferring to hold them in reserve potentially for a strategic transaction.

The other thing that I think it's worth noting is we haven't really set terms for them. So when we thought about this, we could set all different type of terms at different levels. And so it didn't make sense to reduce them because they don't have a value right now. And then the final thing and probably most important to this question is that NASDAQ actually has protections, as Jeroen was mentioning, for shareholders on voting rules.

So you can't use preferred shares to overcome a vote. At least we don't know of anyone who has. The only time we've seen people use preferred shares for NASDAQ voting is to obtain a quorum. And so super voting preferred shares are not allowed. And so I wanted to allay those concerns because we don't have a plan to use them. And frankly, NASDAQ won't let us.

Okay. Thanks, Ed. Next question comes from -- again, 2 people have asked this, Stephen S. and Ed R. Can the preferred shares be issued at any time? Are there any guardrails around how they can be used? For example, it's one thing if that those shares are needed to secure a partnership, but entirely different if they were to be issued to the Board of Directors or sold to an institution. Any thoughts on this?

Yes. So I think if I didn't answer it as fully, I'll try to do so now. There's a NASDAQ rule on voting. And it basically says that preferred shares can only be used in certain ways. And with regard to voting, they cannot be used to overcome common share voting. They can only be used. It's really proportional to the contribution to the company. And if you read that the right way, then what you're getting out of that is if preferred shares are at a premium, then maybe that proportional premium can also convert to proportional voting, but that's the only way you can do it. So again, preferred shares are -- there are a lot of rules, and they protect shareholders.

Yes. So from our standpoint, right, the interesting part is we're asking that you vote so that we can be back on NASDAQ, and that has better guardrails for the stockholders and higher compliance standards as both Ed and Jeroen have mentioned. So we actually want to be there, and I think you all would want us to be there for those exact guardrails because on OTC, had we decided to use these preferred shares, we would have done that already. But again, for the long term, we think it's better to be on NASDAQ to have the compliance and the guardrails because we think that's the type of company that you all would want us to be.

Okay, thank you. Next question is from Anil K. Even though the range of potential reverse stock split ratios has been significantly reduced, some stockholders wonder if the Board has a particular target stock price in mind. Thoughts, Steve?

Yes. So first of all, NASDAQ does require us to be above $1 if we're back on there. This came up briefly at the NASDAQ hearings panel and the current plan is to target a range between $5 to $10 post split. That seems to be the norm of other companies who have a reverse stock split. So we're going to stay with that. And of course, the ratio will depend on where the stock trades when we have hopefully the approval.

Okay, thank you. Next question from Tim S. Shareholders think that if the reverse split is not approved, the Board will authorize the use of preferred shares to take over the company. Is this the case?

Yes. So this question was asked by another stockholder. And I'll first say once again, if we were to do this, we would have done this already while we're on OTC. We really want to operate as a higher compliance company meeting the NASDAQ rules there.

Yes. And if we're on NASDAQ, just want to point out with regard to change of control that there's a 20% rule on NASDAQ that prevents essentially a minority takeover. You're required to have a shareholder vote if you issue more than 20% of your shares, new shares. And again, if there's a change in voting power of more than 20%, there's also a requirement for stockholder approval.

Okay, thank you. Next question is from Aaron A. There are enough studies and proof that reverse splits never recover any losses for early and long-term investors. How are you going to convince them that reverse split is in their best interest when they stand to lose their investment?

So I'll actually start. We did some research. And first of all, we actually -- when you look at reverse splits, I think you have to make a differentiation between biotech companies and other companies. A lot of other companies, you can do the -- literally a Google search, and it will come up this way. A lot of other companies, a reverse split is very much oriented towards companies that are really in trouble and running low on capital and also the prospects are low.

But biotech companies are developing drugs and trying to get to inflection points. And so it's common for biotech companies to do reverse splits. I have friends in south San Francisco where we work, who are also general counsel and a number of them have done reverse splits, relatively common.

And the other aspect is that what happens with biotechs is it has much more to do with the inflection points and the data. And if the data come in, then the company not only recovers but succeeds. And of course, if the data doesn't come in and the company is indeed in trouble, but it has more to do with the company's underlying valuation based on the science than it does the reverse split itself. Not that, that doesn't have some effect, but overall, over time, it has more to do with whether the company is going to succeed scientifically. Anyone want to add or are we good? I think we're good.

Okay, thank you. Next question is from Sunny S. In June 2024, why did you raise capital immediately after the BARDA award and not wait for the stock to appreciate and value more? Steve, can you take that?

Sure. So back in June 2024, as a company, let's -- first of all, think about where we were, right? We had not signed a BARDA agreement as of yet. So we were trying to convince BARDA that it was worth the project award of $460 million. And then secondly, we were looking at the fact that we needed to extend our runway. And so there were 2 important initiatives going on at the same time. And from our standpoint, it was important to have both of those occur.

First of all, as folks know, we've had 2 stop work orders with this BARDA agreement. So having that capital that we raised has been important for us as we weather the ups and downs of some of the health care headwinds. Secondly, I think we're really thankful that we have the capital because it allowed Sean and James and their team to move forward with our norovirus Phase I, and we're just delighted that we have positive Phase I results. So that's been important. And frankly, I don't think we'd be all in this room right now speaking to you if we didn't have that $40 million raise. So we really are thankful that we were able to actually do that at the same time.

Okay. Thanks, Steve. Next question is from Nick S. What steps can Vaxart take to extend its cash runway to allow sufficient time for meaningful catalysts to develop? How much further could costs realistically be reduced? And how much additional runway would that provide? Jeroen, could you take that?

Yes, I'll take that one. So I guess, first of all, I guess, we've already made some of these cuts however difficult they are, right? They involve real people here in the company that we have long-standing relationships with. So we did make the painful decision to do a 10% reduction in FTEs in the first quarter, followed by another 21% reduction in the second quarter. So we feel that at this point, the remaining resources are essential to sort of to complete our ongoing studies and prepare for the next steps in our COVID, norovirus or flu programs.

So I think from my experience as well, working in biotech, as Ed talked about, you really cannot sort of cost cut your way to success. We really need the resources to drive the programs forward and clearly be efficient along the way, but then drive to these key inflection points that demonstrate that this works or doesn't work in these particular indications. So we can and have cut the cost to get to the inflection points, but we now need the capital and all the ability on NASDAQ to access it to continue to develop the products for success.

Okay. Thank you, Jeroen. Next question is from David W. What's taking so long to get a partnership? Why aren't you providing shareholders with regular partnership updates? Let's see. Steve, could you take that one?

Yes. So first of all, thank you, everybody, for your patience as we work through the partnerships. As folks around the room can attest, I'm probably the most impatient guy in the room here. But these partnerships do take time. So when we announced the positive top line results in June, we immediately had meetings at Bio, and those partners got exposed -- potential partners got exposed to the top line data. But now they're doing their diligence, right? They want to see all the data behind the top line data, and that takes a bit of time with diligence.

We're also going back and forth on other matters. But they're also under confidentiality, which is also the reason why we're unable to provide, let's say, the interim updates. But certainly, if there's anything material, we will share that with everybody.

Okay. Thank you, Steve. The next question has been asked by several investors actually. Why aren't you more proactive press releasing updates with BARDA? Ed?

So it's Ed. I'll try to answer. I'll answer that. Thank you. Since I'm responsible for press releases as legal, making sure they're entirely accurate. We -- as a general matter, we try to -- we have disclosure obligations. We try to press release as much as we can because that is a favorable news that we can put out to the market, and that benefits our shareholders, of course, and our company. Our interests are aligned there.

With regard to BARDA, we have a contract and under the contract, they have review privileges. And those review privileges actually require -- they have their own process. They have told us that they can sometimes expedite review, but I've yet to see them expedite review in more than -- in less than, say, 4 or 5 business days. We often have an obligation to disclose as soon as we possibly can as material events. And so if there are unanticipated material events, we determine whether we can press release.

We talk to BARDA and determine whether we can press release and/or get to the point where we have to 8-K the matter. And so what you've seen from us is we have press released on various BARDA milestones. But if you look at them, they're generally the kind that can be anticipated, such as signing a new modification to the contract or reaching certain enrollment levels or dosing patients. And if you look at the ones that have -- we haven't press released, it's almost always because they were unanticipated such as the lifting of the stop work order. So yes, wherever we can, we'll press release, obviously.

Okay. Thank you, Ed. Next question is from Carmen L. Is management trying to squeeze out retail shareholders? Steve, could you take that one?

Yes. The short answer is no. First of all, there's lots of regulations that protect shareholders, whether it's from the SEC or NASDAQ rules. We're really focused on delivering on the science and hopefully being able to raise funds to continue to do that. And just as a reminder, management is also in the same situation as all shareholders. And so more importantly, I think we want to find a way to get back on NASDAQ and have the protections for all shareholders.

Yes. And again, as you said, we're passionate about the science, and we know the shareholders are as well. And obviously, we need their support.

Definitely.

Okay. Next question came in from several investors as well. Many people theorize that dark pool trading and short sellers impact trading in Vaxart. Did you investigate this? So let's see. Ed, could you take that one?

Sure. Yes, I can say that we have thoroughly evaluated dark pools. And to our knowledge, dark pools are just another way of trading sort of off a listing or off market. We haven't been able to find specific circumstances that actually would constitute a legal issue such that we could either bring in action or refer to a regulatory body.

We've also told our stockholders who have concerns about this that if they have evidence, then they should bring it to either our attention or report it to regulatory bodies who can investigate. We're more than open to ensuring that our stocks are traded above board and fairly. But we have a limited ability to investigate in certain instances. So I want to encourage people to bring things either directly to the regulatory body or again, if you bring them to us, we'll ensure that regulatory bodies are apprised of it and can do the proper investigation wherever possible.

Okay. Thank you, Ed. Next question is from Diane H. The thing holding the stock price down is not OTCQX. It's a reverse split on the proxy looming. This has been months. That is what keeps new investors away and keeps the stock price down. Why do you keep telling us to vote for the reverse split? And let's see. Steve, could you take this one?

Yes, I can go and take this. One of the things that we're at least hearing now is that being on OTC is making us slightly less attractive to certain investors who have a requirement that their investment committees require that the stock is on NASDAQ. So that's certainly contributing to that. We've actually received some inquiries from investors who want to invest and are asking, "When will you be back on NASDAQ? I hope the reverse stock split proposal goes through."

And there was a time where we did not pursue the reverse stock split. And I think all of us were hoping organically that the stock would go above $1. It did not. And again, that's still our preference. I want to be very clear, is for the stock to go up organically. But at this point, after having the hearings panel with NASDAQ, if it doesn't happen organically, they are requiring us to look at a reverse stock split. And again, we'll get the final results of their ruling hopefully in 2 to 4 weeks.

Okay. Thank you, Steve. The next question is -- a second question from Travis. Why did you keep Bob Yedid on the Board when he pleaded guilty of insider trading? What steps have been taken to look into any legal trading within Vaxart? Ed, could you take this one?

It's Ed. Yes, sure. I can take it. We -- the individual -- well, Bob resigned from the Board right around the time that we became aware of the allegations against him. So we didn't have a lot of advanced notice. But our Board pretty much acted swiftly and decisively to ensure that he was off the Board. If you look at the charges and they're in public documents from the government, you'll see that his activity didn't involve his role at Vaxart and also his trading, alleged insider trading was not directed at Vaxart.

We have processes for directors to self-report, and we have requirements that our law firm regularly asks directors about their activities. And in this case, I would argue the process worked because Bob actually tendered his resignation. I can't guarantee the timing. But as far as I know, it's when -- more or less when he became aware of the allegations against him. And we have compliance programs to ensure that Board and executive stock transactions are reviewed and cleared before they take place.

Okay. Thank you, Ed. This next question, I think -- James, if you could answer this, it's from Diane H. Top line results for the Phase II COVID trial will be in late 2026. Noral Phase II was months from even starting. Why is this taking so long?

Thanks for the question, Diane. With limited resources, we've managed to generate, I think, important inflection points this past year, and we have more inflection points in the near future. The sentinel cohort readout in Q1 of '26, that's going to provide an inflection point that gives us insight into our larger, currently approximately 5,000-persons KP.2 participant study in the COVID clinical trial.

Our Noro data, that came out in June, and we've held constructive conversations with many potentially strategic partners since then. As Steve mentioned earlier, diligence takes time. I'll also say we had important interactions with the FDA that fed into our development plan for Noro. In terms of where we are in terms of our runway, Jeroen, do you want to talk about that?

Yes. And I think it's an important thing to highlight here, right? So it's not like we don't have a fire lit under us. We have publicly disclosed that our remaining cash runway is into the first quarter of 2026. So we have every reason to make sure that we act as quickly, efficiently and as we can to get to these inflection points. So acting in that manner and then being back on NASDAQ will be essential for us to make sure that we have both the right terms if we need to go back and raise money on public markets and maintain the credibility with partners, government and others to get to the nondilutive options at the same time.

Okay, thank you. Next question is from Paul C. Given the growing public skepticism toward mRNA vaccines, it seems like an ideal opportunity for Vaxart to clearly communicate how its platform differs and why it may offer a safer or more effective alternative. Could you please share why this distinction isn't being emphasized more in public communications and provide any insight into the time line or challenges related to advancing your COVID program to Phase III? And I think, James, this is another question for you.

It sure is. And thanks, Paul, for your question. So much of the data we've generated to date really is focused on differentiating our product, and we have already compared our platform to mRNA in the lab in preclinical testing. We're focused on achieving inflection points that further elucidate our efficacy and our safety profiles. And as the data comes in, for example, in the Phase IIb trial, we'll have data that form an important comparison head-to-head against an mRNA. Building on that data and end of Phase II meeting with the FDA is going to be integral to advancing to the next step, which would be a Phase III. I hope that answers your question.

Okay. Thank you, James. Next question is from Beth G. And this is related to the stop work order. If the stop work order is not lifted, what are the company's plans to continue its clinical trials? And what options does it have to advance its promising pipeline? Does Vaxart's current cash position provide enough runway to achieve any critical milestones that may result in a step-up in valuation. So I think this is a two-pronged question. So James, maybe you can take the first part.

Sure. So our second stop work order, it's different than the first one received since we've already enrolled about 5,000 participants in that KP.2 cohort. When we received the first stop work order, we hadn't enrolled anyone in that cohort. 5,000 participants, that should give some pretty useful information in support of our clinical regulatory development pathway. That's how I see it. Jeroen, do you want to talk in terms of the cash position piece?

Yes. No, that's -- definitely happy to. Thank you, James. So when it comes to cash position, clearly, the readout on -- even if it was sort of ended up being a 5,000 participant study, there will be readout in the second half of 2026. As I mentioned earlier, we have cash runway into first quarter of 2026. So we have a gap to cover. So what we're doing today, as we've talked about, I guess, clearly evaluating industry partnerships, looking at potential grants from governments or nonprofits, looking at venture debt and all other nondilutive options. But again, the listing on NASDAQ is essential to allow us to potentially have an equity option for raises as well.

Okay. Thank you. We have a follow-up question from Michael P. related to the June 2024 raise. So he said, going back to the June 2024 raise, elaborate more on the decision behind it. Was it already in play?

Yes, I can go ahead and take that. This is Steve. So again, if I understand the question directly, it's around when we had the BARDA award given to us and then at the same time, raising the $40 million. And so both of them were going on concurrently. These are 2 important initiatives as a company as part of our corporate goals for that year. Number one, let's see if we can get a BARDA award to run our COVID Phase IIb trial. And then secondly, we do need to raise more capital in order to extend our runway.

And so those 2 initiatives were going on at the same time. It certainly happened that the way that a contract is executed with ATI/BARDA is we signed first and we wait for them to execute it. And as soon as they execute it, that becomes a material event, and we, of course, had to announce that. Concurrently, we were also in the process of raising capital. And once those terms were agreed to, we also had to announce that as well. So hopefully, that answers the question that they were both going on at the same time.

And again, as we were talking about earlier, we're really happy that we have that capital because it allowed us to get to the point where the research and development team was able to move forward with the norovirus Phase I as well as some of the other work that we've been doing with HPV as well as with avian flu.

Great. Thank you, Steve. Next question is from Eric E. Even if the stop work order is lifted, the BARDA funding only relates to costs associated with Vaxart's COVID program. How does Vaxart plan to advance development of other promising prospects in its pipeline? And let's see. Steve, do you want to take that one?

I'll give to Sean.

From our standpoint, and again, the question was how do you advance development of other programs? Well, Steve just talked about the fact that we were able to raise money and we were able to do a lot of work in terms of reengineering our platform and showing that it worked on some indication like norovirus. And I think that was really critical from the standpoint of showing that these changes that we're doing could be implemented for something and show human data.

We've gone back and reengineered it, every indication. That data is going to be helpful from the standpoint of basically showing that we can do better. And again, one of the key things is right now, we're a leader in mucosal immunity. We want to basically make sure that we're in a great competitive position in the future.

Okay, thank you. Next question is from Ricardo L. What are partners looking for from Vaxart as they consider whether to partner with Vaxart?

Yes. So when we had our meetings at Bio after the positive Phase I norovirus study, both Sean and Ray were actually part of these meetings. So I think it might be good for maybe Sean first and then Ray to just talk about what some of these discussions were.

Sure. I mean some of the big questions that came up and some of the things we had to show is, hey, do you have a profile that really is differentiated from what's out there? How are you different from mRNA? How can you do things differently? And again, one of the things that partners really want to know is how likely are you going to be able to have success in a pivotal trial, something that's going to be useful for registration?

And for norovirus, this is one of the reasons why the Corallits work that we did and showing these new constructs were important were really critical from the standpoint of moving these partner discussions along.

Yes. Thanks, Sean. One of the items that's typically not top of mind for most people is manufacturing readiness, and that's because this typically occurs in the background while critical clinical trials are being executed. In reality, other than the inquiries on those clinical trials, this is one of the top questions we receive from these potential partners.

In general, people want to know if we have a scalable manufacturing process that's reliable, robust and generates enough output to be commercially viable. The good news is that we're ready for these questions. Vaxart has been committed to ensuring our manufacturing readiness over the past few years, and we're very fortunate to have all of our clinical manufacturing development capabilities located in our facilities in the United States. These capabilities were on full display last year when we were able to use them to quickly pivot our COVID vaccine candidate from XBB to KP.2 in order to keep Project NextGen program running along.

Okay. Thanks, Ray. Next question is from several investors. COVID therapies were developed quickly during Operation Warp Speed. So what's taking you so long? And let's see. James, could you take that question?

Sure. Why don't I take the first part and maybe Sean can comment. So Operation Warp Speed, it occurred during a pandemic. Now COVID is endemic. It's a little more common. So there's already approved products on the market. This is reducing the need for any type of emergency use authorization, et cetera. Sean, do you want to talk about where we are in development?

Yes. I mean, I think from the standpoint of because we are able to do this at what I would say, a more manageable nonpandemic pace, we are able to do spend a lot of time in improving our constructs. And again, Ray talked about all the things we've done in terms of improving manufacturing, which is really important. And again, the key thing from our standpoint is all this effort and extra time, we'd been able to show the differentiation and how well our candidates do and make it more attractive and commercially viable.

Okay, thank you. Next question, another question from Diane H. Why can't you expedite your bird flu trial?

Yes, I'll take this. Again, from our standpoint, we're excited about the data. We're very bullish about our avian flu program. We think it'd be very successful. But similar to other programs, we are definitely exploring different avenues to fund this going forward. We know that there have been several government initiatives looking at ways to protect against the indication. Given that many of the mRNA approaches have been canceled, there actually might be more money available for novel platforms, unclear, but maybe there is.

Right now, one of the other issues is there's not a commercial market for avian flu vaccine. We do think that our best opportunities to advance this program is to partner with governments and make sure that we have support going forward.

Thank you, Sean. The next question is from John M. Relative to standard option and shares of stock delivered to executives during the annual meeting, why was there a change of vesting to less than 1 year to be available for voting next annual meeting as compared to the usual 4-year period? When did this change? Or is there a reason relative to future voting or the reverse split? Why the acceleration?

So this is Ed. I'll answer this. We have not changed our vesting schedule. All equity that has been awarded, has been awarded on the same vesting schedule. So I'm not sure if that just was a misreading of some of our documents. But I can assure you that our vesting schedule has been in place at least since I've arrived at the company 3.5 years ago, and will continue to do so.

The other thing to say is that we try as hard as possible to award on a regular basis, in other words, yearly at about the same time, and we need to make awards when the people making the decision about awards are not in possession of material nonpublic information. And that's what we do to protect shareholders and the company from inappropriate activities with regard to our equity.

Thanks, Ed. Next question is from Veteran J. Why are you selling/offering shares to companies that sell those millions of shares shortly after buying, affecting share price negatively? Why not sell shares on open market, retail shareholders hold shares for a long period and help keeping price at a higher level?

Yes, I can go ahead and take that. So when we do offerings, certainly, since I've been here, we are looking for those investors who are in it for the long haul. So that is one of the criteria. And so we certainly have attempted to do that. In terms of selling shares in the open market, we have also done that with an ATM, and there has been times where we've done that.

But I think the other thing, as Jeroen had mentioned, that we are investigating is how do we involve current shareholders in future offerings. I'm not sure, Jeroen, if you want to add any more color in terms of what we're researching in that regard.

Yes. No, clearly. So the type of transactions that I think are being referred to here are probably more like registered direct offerings and things where we go out to a limited set of parties for an offering.

So I think the things that we're looking at clearly more public offerings like I think Ed talked about previously as well, sort of like a rights offering and things like that. So that would allow participation of current shareholders in the offering and make sure that both the terms are very competitive and equal for everyone and again, allow you as a current holder to prevent any dilution of your stake in the company.

Okay, thank you. Let's see, next question. If the reverse split fails, does Vaxart intend to make another attempt at a reverse split? Or would management primarily focus on execution, advancing partnerships and achieving key milestones while continuing to trade on the OTC? I think you mentioned this already, but what are your fundraising options as shareholders vote against the RS proposal?

So regardless of what happens, in fact, we've been doing this, right? We are very focused on the execution of all of our important programs, including trying to find partnerships as well as making sure that our COVID study continues to proceed. As James mentioned, right, we were really happy when we received the second stop work order that we worked so hard and fast to get to 5,000 subjects. And so hopefully, that's evidence of just how hard we are working to get to important inflection points.

If I can just add, I guess, yes, I think it's -- clearly, our execution focus will not fade in the light of all this. But yes, trading on OTC, it just makes it harder for us to raise funding and makes it more expensive for all of us to raise funding. We understand that nondilutive options are clearly highly preferred, and that's why we're so focused on industry partnerships. We're working hard on government grants at all times.

We're even looking into things like venture debt as nondilutive options, but we have to look at equity financing to allow us to move the programs forward. And yes, being on OTC just makes that really difficult and really expensive for all of us.

Okay. Next, and I think probably the last question is from Michael P. Can you talk about when do you think the peer-reviewed piece will come out? And he's referring to Sean's results in the avian flu study with ferrets.

Yes, that's a good question. I mean, again, one of the key things is, one, we have to finish all the reports and data. And then at that point, you submit your paper. And again, sometimes the journals react very quickly and sometimes they don't, and you don't have much control of it. So I'd like to say that we would try to submit this year, but I can't promise that 100% either.

Okay. Thank you, Sean. And that's all the time we have for questions. So at this time, I'll hand the floor back over to Steve for any closing remarks. Steve?

Thanks, David. And let me just say thanks to all of our stockholders for your questions today. We hope that you found today's fireside chat helpful, informative, but also genuine. We really don't have a hidden agenda here. We want to create stockholder value no matter what stockholder you are, right? As fellow stockholders, we are in this together. When the company succeeds, we all benefit, especially those we help with our science.

So as a quick reminder, our Special Meeting of Stockholders to vote on the reverse split will be held on Friday, September 5, at 8:30 a.m. Pacific Time. Please review the instructions carefully on your proxy to ensure that your vote is counted. Every vote matters, and we strongly urge you to vote for the reverse stock split proposal. If you have not done so yet, please submit a proxy or voting instructions to vote your shares by 11:59 p.m. Eastern Time on September 4, 2025, in order to ensure that it's counted.

Stockholders who wish to change their vote can do so before the final vote at the stockholder meeting. We also know that many of you have likely seen a lot of speculation and incorrect information in online forums or on social media. I really urge you to rely on the facts that we provided and also the recommendations outlined in reports by independent firms like ISS and Glass Lewis, who make comments on Fortune 500 companies as well as companies like us. Before we end the meeting, I'd like to just turn it over to our founder, Sean, for his closing remarks.

Thanks, Steve, and I really appreciate your diligence and dedication. And I'm really grateful for the support of the stockholders in helping us develop what could be the Holy Grail of vaccine platforms. The dream of mine is that we could develop a vaccine that could come to your house rather than having to go wait in line. And I do believe that our old vaccine platform could do this.

The science has dramatically improved in the time I've been invested in this dream, but there are still steps left for us to do before we get regulatory approval. I'm a competitive guy and why I believe we are ahead of other mucosal vaccine platforms, we at least need to be on equal footing. Being on NASDAQ helps us compete rather than being at a competitive disadvantage. And I encourage the stockholders to vote -- help us and vote yes on the reverse stock split proposal.

Thanks, Sean. It continues to be a pleasure working side-by-side with you, and we look forward to the future here. Operator, you may close the call.

Thank you. And that concludes today's webcast. All parties can disconnect.

Greetings, and welcome to the Vaxart Business Update and Second Quarter 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel. Please go ahead.

Good afternoon and welcome to today's call. Joining us from Vaxart are Steven Lo, Chief Executive Officer; Dr. Sean Tucker, Founder and Chief Scientific Officer; Dr. James Cummings, Chief Medical Officer; and Jeroen Grasman, Chief Financial Officer.

Before we begin, I would like to remind everyone that during this conference call, Vaxart may make forward-looking statements, including statements about the company's financial results, financial guidance, its future business strategies and operations and its product development and regulatory progress, including statements about its ongoing or planned clinical trials. Actual results could materially differ from those discussed in these forward-looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process and other risks described in the Risk Factors section of Vaxart's most recently filed annual report on Form 10-K and also on other periodic reports filed with the SEC. Vaxart undertakes no obligation to update any forward-looking statements after the date of this call.

I'll now turn the call over to Steven Lo. Steve?

Thanks, Ed, and thanks to all of you for joining us this afternoon. I'll begin today's call with an overview of our business. Then, we'll pass the call to James and Sean for the latest developments of our clinical and preclinical programs. Jeroen will share an update of our financials. And finally, I'll have some comments related to our stock listing before we open the call for your questions.

Starting with our COVID-19 clinical program. Last week, we received a second stop work order notice on our Phase IIb trial from Advanced Technology International, or ATI, the Rapid Response Partnership Vehicles consortium management firm funded by BARDA. Like the first stop work order, this came as a surprise to us without any advanced notice. Unlike the first stop work order notice, when we had not yet enrolled anyone in the 10,000-participant cohort. We were glad that this came to us when we had already enrolled approximately 5,000 participants. And the notice allows us to continue the study for those already enrolled. We continue to believe there is huge potential for our promising oral pill vaccine candidate for COVID. Enrollment for this trial was proceeding at a rapid pace since we dosed the first participant in late May. These trends highlight the strong public interest of our oral vaccine platform and for a safe and effective vaccine against the SARS-CoV-2 virus.

We agree with Secretary Kennedy's priorities that include the development of safe and effective novel vaccine solutions such as our oral vaccine platform. As a reminder, our trial is designed to assess the safety, immunogenicity and efficacy profiles of our candidate against an mRNA comparator. This trial is specifically designed to provide head-to-head data with the goal of advancing broader and innovative vaccine technologies.

Although we were trending towards fully enrolling this trial by mid-Q4 as we had projected or even earlier, we remain encouraged about the prospects of the trial and our vaccine candidate since there will be data on about 5,000 participants. We remain in close touch with our BARDA partners and ATI as they indicated that a follow-up notice with further details will come.

I'd like to express my appreciation for the work of our clinical teams and investigators across our sites as they continued the important follow-up work on this trial. We also thank the clinical trial participants whose strong interest is making this key study possible. COVID remains an endemic infection that has a morbidity and mortality profile that is more adverse than flu. And while vaccination has waned, the market opportunity remains quite significant. And of course, we anticipate that our differentiated mechanism of action plus delivery as an oral pill can change the trajectory of vaccine acceptance and convenience.

Turning to our norovirus program. In June, we were pleased to report positive Phase I top-line results from our second-generation constructs, which increased norovirus blocking antibodies in both the low and high-dose cohort with the difference reaching statistical significance for the high-dose cohort. Compared to our first-generation constructs, our new constructs were optimized to generate stronger immune responses. We plan to share the complete results of the study in a peer-reviewed journal. But it's encouraging that our second-generation constructs have shown meaningful improvement on an important marker of protection against norovirus infection. And that the data continue to show they are well tolerated with a benign safety profile.

We believe this has first-in-class or best-in-class potential as currently, there are no approved vaccines. And other products in development do not have the unique profile as well as delivery advantages of our platform. With continuing outbreaks in the news and a significant burden on society, norovirus represents a significant unmet need.

As we have shared before, norovirus is believed to cause 20% of diarrheal disease globally and is the leading cause of acute gastroenteritis or AGE worldwide. This highlights the public health potential of our oral norovirus vaccine. The healthcare economic cost of norovirus infection and associated AGE are estimated at $60 billion worldwide and $10 billion in the United States. This underscores why market research estimates the potential of a multibillion-dollar U.S. market for a safe and effective norovirus vaccine.

Following the release of norovirus top line data, our leadership team attended the BIO International Convention in Boston. We held many productive one-on-one partnering discussions throughout the conference. And while it's too early to share specific details about a potential partnership, I'm pleased to share that we have meaningful interest from many parties. We will share more information, of course, if a partnership is achieved.

Finally, we are progressing our preclinical research in avian influenza. As Sean will highlight, our new avian influenza vaccine was 100% protective against death in a robust ferret clade 2.3.4.4b challenge model compared with 0% survival in placebo-treated animals. Based on our growing body of data, we believe there is potential for our seasonal and avian influenza vaccine candidates and plan to look for funding to continue development of these programs.

Overall, our broad pipeline with programs in norovirus, COVID-19 and influenza have a number of upcoming value-creating milestones. With a platform designed to generate both systemic and mucosal immunity, we believe our oral pill vaccine has the potential to transform global public health and revolutionize distribution and administration.

I'll now turn the call over to James for a review of our COVID-19 and norovirus clinical programs. James?

Thanks, Steve, and thanks to everyone for joining today's call. I'll start with an update of our COVID program. After our initial stop work order was lifted in April, we quickly activated our clinical sites, resumed participant screening and initiated dosing in the 10,000-participant cohort, all within about 1 month's time. As Steve mentioned, we were well on our way to achieving our enrollment targets with about half of the participants enrolled earlier this month.

However, with the latest stop work order, we immediately ceased enrollment. It's worth mentioning, though, that the Independent Data Safety Monitoring Board, or DSMB, for this trial, tasked with assessing the safety of the trial had determined at its meeting in mid-July that the study could continue to proceed without modification, providing further evidence of the safety profile of our vaccine candidate. As a reminder, this Phase IIb trial is a double-blind, multicenter, randomized comparator-controlled study. It's designed to evaluate the relative efficacy, safety and immunogenicity of our oral COVID-19 vaccine candidate compared to an approved mRNA COVID-19 vaccine in adults who have been previously vaccinated against COVID-19.

Based on the stop work order notification, we will continue to conduct a 12-month follow-up for all participants who have already been dosed in the trial, which will be funded by BARDA. As we determine next steps for the trial with approximately 5,000 participants enrolled, we believe we will still produce a very comprehensive data readout that is anticipated in 2026.

We're also continuing per protocol follow-up work for the 400-person sentinel cohort, which BARDA will continue to fund. Participants are being monitored for up to 12 months post vaccination to assess safety, immunogenicity and efficacy for the sentinel cohort. We expect to report data in the first quarter of 2026.

During the second quarter, we reported positive top line results from the Phase I trial comparing our first and second-generation norovirus vaccine constructs. These data showed that our second-generation constructs stimulated higher levels of norovirus blocking antibodies than the first-generation constructs at both the high and low doses evaluated in the trial. The difference was statistically significant in the high-dose cohort. As we've previously shared, these norovirus blocking antibodies correlated with protection against norovirus infection in a Phase II challenge study of the first-generation constructs, which demonstrated a 30% relative reduction in the risk of infection.

We believe that the blocking antibodies raised by the second-generation constructs will also be protective against infection. Given that the Phase I head-to-head trial showed higher levels of norovirus blocking antibody with the second-generation constructs, we are optimistic that this will translate into a greater reduction in infection in a field study. We believe that the potential of our second-generation constructs combined with the significant public health need and market opportunity for a safe and effective norovirus vaccine provides us with a meaningful opportunity to attract additional funding that will allow this program to move forward.

With a potential partnership or other funding, this program could advance to a Phase IIb study in the second half of 2025, enabling an end of Phase II meeting with the FDA that could support Phase III trial initiation as early as 2026.

I'll now hand the call over to Dr. Sean Tucker for the latest developments from our avian flu preclinical program. Sean?

Thank you, James. As many of you are aware, the H5N1 strain of the avian influenza is circulating in wild birds around the globe and causing outbreaks in poultry and dairy cows in the United States. According to the U.S. Centers for Disease Control and Prevention, 70 cases of human H5N1 infection have been reported since the outbreak began, resulting in 1 death. This is not just a U.S. virus with reported cases in Southeast Asia and other places. According to the World Health Organization, there were 15 laboratory confirmed cases of human infection with avian flu in Cambodia this year.

While there is no known evidence of person-to-person infection at this time, the continued circulation of the virus increases the risk of mutations that could make animal to human transmission easier or result in human-to-human transmission. Additionally, individuals currently working with Gary Herds at poultry farms or have contact with potentially infected animals could benefit from a safe and effective avian flu vaccine.

A key benefit of our vast vaccine platform development is that it allows us to move quickly in formulating and evaluating novel vaccine constructs. Given the potentially growing threat of avian flu, we were able to develop and commence preclinical evaluation of a new avian flu construct in just a few months. Subsequently, we performed a challenge study of this construct where it demonstrated 100% survival and reduced viral load.

In this study, ferrets were vaccinated twice with an old H5 vaccine, a new H5 vaccine or placebo. Eight weeks after the first vaccination, they were challenged intranasally with H5N1. 100% of the ferrets receiving the new H5 vaccine survived, while all the animals received placebo died by day 6 post challenge. Three of 8 animals receiving the old vaccine were still alive after 9 days after challenge. In addition to the survival benefit observed with the new vaccine, the study showed a greater than 2 log reduction in nasal wash viral load in ferrets receiving a new vaccine. And this decrease was statistically significant compared with the old vaccine and placebo.

We believe these data are highly compelling and have the potential to support a partnership or business development opportunity. We intend to report the data from these and other studies of our avian flu vaccine candidate in a peer-reviewed journal or peer-reviewed medical or scientific conference.

I'll now hand the call over to Jeroen for a brief discussion of our financials. Jeroen?

Thank you, Sean. The details of our second quarter 2025 financial results are summarized in today's press release. Revenue for the second quarter of 2025 was $39.7 million compared to $6.4 million for the second quarter of 2024. Revenue in the second quarter of 2025 was primarily from the BARDA contract awarded in June 2024. Revenue in the second quarter of 2024 was primarily from a separate BARDA contract awarded in January 2024.

Vaxart ended the second quarter with cash, cash equivalents and investments of $26.3 million. Based on our current plan, Vaxart expects cash runway into the first quarter of 2026. To further extend our cash runway, Vaxart will remain aggressive in seeking strategic partnerships and pursuing other nondilutive funding options.

In addition, following an approximately 10% reduction in workforce during the first quarter of 2025, the company implemented an additional reduction in workforce during the second quarter, reducing its workforce by a further approximately 21% to decrease operating costs and better align its workforce with the needs of its business.

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

Thank you, Jeroen. I'd like to use this time to provide an update on our stock listing before taking your questions. As many of our listeners are aware, our listing on NASDAQ has been suspended because we are not in compliance with NASDAQ's $1 minimum bid price requirement. Since July 8, our common shares have been trading on the OTCQX best market. While this exchange is the highest tier of the OTC Markets Group, our goal is to regain compliance on NASDAQ, so that we can resume trading on that exchange.

While we continue to consider all options in an effort to have NASDAQ lift its suspension of our common shares and appreciate the continued support from our stockholders. We continue to believe that listing on NASDAQ is the best option for the future of Vaxart. We have a meeting with the NASDAQ Hearings Panel tomorrow to discuss our plan to regain compliance, which based on our current share price is to effect a reverse stock split. We will share an update once a decision has been communicated to us. However, there is no assurance that NASDAQ will support our plan.

To that end, we have scheduled a special meeting of stockholders to be held virtually on September 5 at 8:30 a.m. Pacific Time and urge a vote for our reverse stock split proposal. A similar proposal was not approved during our annual meeting in June as many of our stockholders at that time believe that were Vaxart traded on the OTC that our share price would grow organically for a smoother path to listing on NASDAQ. As we previously stated, we do not believe our current stock price reflects anywhere close to where we believe is the full value of our company.

However, since our listing on OTC, our share price has not appreciated in a meaningful manner, trading between $0.26 and $0.47. We are less attractive to institutional investors and passively managed index funds who often have mandates against investing in OTC-listed companies. And following BARDA's stop work order notification, relisting on NASDAQ is now more important than ever. NASDAQ-listed companies are often viewed more favorably for potential partnerships, making this a critical step for future collaborations.

It is for these reasons that we strongly believe that voting for the proposal is in the best interest of Vaxart and for you, our stockholders. In an effort to proactively address questions regarding this proposal and other frequently asked stockholder questions, we will host a live fireside chat on August 20, 2025, at 4:30 p.m. Eastern Time. We encourage you to either send questions in advance to [email protected] or live through the webcast player. We will do our best to answer as many questions as possible with the hope that we can secure your vote.

As a reminder, in the event that we receive stockholder approval before proceeding to effect a reverse split, we will first evaluate our situation to determine the likelihood of regaining compliance with NASDAQ. While we work towards regaining compliance on NASDAQ, our clinical, regulatory and operational teams are executing at a high level that has enabled us to report positive data and hit key milestones within our stated time lines.

Our Phase I norovirus data, progress with our COVID-19 Phase IIb trial and compelling preclinical data all served as added validation and interest for our revolutionary oral pill vaccine candidates. We look forward to sharing our continued progress. Thanks, everyone, for your time today. We will now take your questions. Since we have our scheduled fireside chat upcoming, we kindly request reserving all questions relating to our proxy for the fireside chat.

Operator, you may open the line for questions.

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

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

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

Your questions on the stats and the ratio, let me turn that over to James.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

And I'm sorry, Mayank, if you can ask the second question again, just for Sean and James?

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

Yes. Sean, you can go ahead.

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

Okay. And also on the avian flu data, is there a publication planned? And what might be the process of securing maybe a federal funding process there?

And lastly, Jeroen, on the R&D spend on a go-forward basis, how should we think about that? And should we assume the spend profile that you have will essentially be in some way reimbursed and it's not going to get impacted by the stop work order?

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

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

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

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

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

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

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

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

Well, there was certainly a robust demand for participating in our COVID clinical study. And I want to acknowledge and thank all the participants and all the study sites and really everyone who worked to rapidly enroll about 5,000 participants. I believe the robust enrollment pace showcases the demand for a better COVID vaccine.

While SARS-CoV-2 virus continues to mutate and remains prevalent around the world, we're looking forward to analyzing the data, which may be available as early as late 2026 to the study participants that have already been dosed.

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

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

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

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

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

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

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

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

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

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

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

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

Thank you, sir. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

Greetings, and welcome to the Vaxart Norovirus Phase I Top Line Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the call 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; and Dr. Sean Tucker, Founder and Chief Scientific Officer. Before we begin, I would like to remind everyone that during this conference call, Vaxart may make forward-looking statements, including statements about the company's financial results, financial guidance, its future business strategies and operations and its product development and regulatory progress, including statements about its ongoing or planned clinical trials.

Actual results could materially differ from those discussed in these forward-looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process and other risks described in the Risk Factors section of Vaxart's most recently filed annual report on Form 10-K and also on other periodic reports filed with the SEC. Vaxart undertakes no obligation to update any forward-looking statements after the date of this call.

I'll now turn the call over to Steven Lo. Steve?

Thanks, Ed, and thanks to all of you for joining us this morning. Earlier today, we issued a press release reporting positive top line results from our norovirus Phase I clinical trial comparing our second-generation oral pill vaccine constructs to our first-generation constructs. We are very pleased to see that the second-generation constructs produced an increase in norovirus blocking antibodies in both the high-dose and low-dose cohorts.

Notably, the increase in norovirus blocking antibodies in the high-dose cohort was statistically significant. In the Phase II challenge study of our first-generation constructs, these antibodies correlated with protection against norovirus infection. We are very optimistic that the significantly higher level of norovirus blocking antibodies observed in this Phase I study with our second-generation constructs will translate into an even higher rate of protection than the 30% relative reduction observed in the Phase II challenge study of the first-generation constructs.

As a reminder, the full data from the Phase II challenge study were published last month in Science Translational Medicine and the press release summarizing the results is available on the Vaxart website. Before turning the call over to Sean for a review of the Phase I data, I would like to take a moment to underscore both the critical public health need for a safe and effective norovirus vaccine as well as the market opportunity that such a vaccine provides.

From a public health standpoint, norovirus is a leading cause of acute gastroenteritis or AGE worldwide and is responsible for outbreaks of infection and illness globally. It is not just a cruise ship virus, but one that infects schools, daycares, social settings, healthcare settings and more. Each year, there are approximately 685 million norovirus infections globally, with 20 million infections occurring annually in the United States. Due to these high rates of infection, norovirus is believed to cause nearly 20% of diarrheal disease globally.

Additionally, the economic burden associated with norovirus infection and AGE is estimated at $60 billion worldwide and $10 billion in the United States. Market research suggests that the total potential U.S. market size for a safe and effective norovirus vaccine is in the multibillion dollars category. This attractive market opportunity is based on the potential use of a norovirus vaccine in several age and risk-based populations, which include those over 65 years old, those who are immunocompromised, people in the long-term care, skilled nursing or assisted living facilities, military personnel, healthcare professionals, first responders, food handlers, child care providers as well as travelers or members of the travel industry.

Realizing the potential of this market requires a vaccine that has several specific characteristics. Of course, providing a durable cross-reactive immune response is critical for efficacy, it must also be safe and well tolerated. However, there are other characteristics that are important for making an effective vaccine broadly available. These include ease of use through the ability to self-administer the vaccine, a thermal stable formulation that obviates the need for complex cold chain logistics, the use of state-of-the-art recombinant technology free of live replicating virus or animal products, which allows use in many populations, including those who are immunocompromised and a modular, scalable development process that allows for rapid adaptation of new vaccines in response to emerging norovirus strains.

Our norovirus vaccine candidate possesses all of these characteristics, and we believe it has first and/or best-in-class potential. Our second-generation norovirus construct is a bivalent vaccine designed to address the major norovirus genotypes currently in circulation by stimulating mucosal and systemic immune response to the GI.1 and GII.4 genotypes. The GII.4 genotype, which accounts for 68% of all circulating norovirus strains is the predominant cause of pediatric illness worldwide and is the overwhelmingly predominant cause of disease among elderly individuals in health care-associated outbreaks.

It also results in more severe illness compared with other GII and GI genotypes. As we have previously shared, preclinical data demonstrate that our second-generation norovirus constructs stimulate the production of more GII.4 and GI.1 specific serum antibodies compared with the first-generation constructs. As Sean will share with you now, we observed this increase in the Phase I head-to-head trial of the first- and second-generation constructs. Sean.

Thanks, Steve, and thanks to everyone on the call. Before I review the Phase I trial data, I'd like to take a moment to provide some context around the rationale for undertaking a head-to-head comparison of our first- and second-generation norovirus oral pill vaccine constructs. As a company at the forefront of leveraging oral delivery to improve mucosal and systemic immunity, we are continually learning from every preclinical and clinical study we conduct and incorporating new knowledge into our vast platform and the design of our vaccine candidates.

As a result of this ongoing optimization and advancing our first-generation norovirus constructs through clinical development, we have applied the information gleaned from those studies into the development of our second-generation norovirus constructs. Additionally, the Phase II challenge seed the first-generation construct utilized a proprietary norovirus blocking antibody assay or NBAA that we developed and showed that higher titers in this assay correlated with protection from norovirus infection. We believe that a Phase I head-to-head study using this assay as the primary endpoint would provide clinical validation of the superior immunogenicity of the second-generation constructs.

Improvements in the NBAA responses, we believe would impact both protection against infection and clinical norovirus disease. Therefore, such validation would give us enhanced confidence to take the second-generation candidate into the later-stage clinical development and potentially toward the market. I am excited to report the Phase I results were consistent with our preclinical studies.

Specifically, we saw significantly increased GI.1 NBAA titers in the cohort receiving the high dose of the second-generation constructs compared with an equivalent dose of the first-generation construct. This was evidenced by a 141% increase in GI.1 NBAA titers, which corresponds to a 3.2% increase in the geometric fold response from 2.2 to 5.4.

We also saw significantly increased GII.4 NBAA titers in the cohort receiving the high dose of the second-generation constructs compared with an equivalent dose of the first-generation constructs as evidenced by an 84% increase in NBAA titers for GII.4, which corresponds to a 1.6% increase in the geometric fold response from 1.9 to 3.5. A low-dose of the second-generation constructs producing numerical increase in NBAA titers compared with the first-generation constructs, which is highly encouraging even if these increases were not statistically significant.

I would like to note that the trial was not designed originally to show statistical superiority. So the fact that we achieved it with a high-dose cohort really underscores the magnitude of the increases in NBAA titers with the second-generation constructs. With respect to safety, all the norovirus vaccine candidates evaluating the study were well tolerated with no vaccine-related serious adverse events.

We expect to publish complete data from this study, including results for the exploratory endpoints of serum NBAA titers at 179 days and fecal IgA against norovirus BP1 at day 0, 28 and 179 in a peer-reviewed journal. I'll turn the call back to Steve Lo for closing remarks.

Thanks, Sean. As we have previously shared, assuming a partnership or other funding, we expect to conduct a Phase IIb safety and immunogenicity study of the new norovirus oral pill vaccine candidate that could potentially begin as early as the second half of 2025, followed by an end of Phase II meeting with the U.S. Food and Drug Administration. A Phase III trial could then begin as early as 2026.

Currently, we believe we have the only norovirus vaccine candidate in oral pill formulation and that the Phase I data we have shared with you today adds to the growing body of evidence supporting the potential benefit of our approach. These data include not just efficacy and safety, but also the very real administration and access constraints that limit the use of injected vaccines. We intend to incorporate these compelling new data into our ongoing discussions with potential partners and believe that they bolster the value proposition of our norovirus vaccine program.

Thanks, everyone, for your time today. Operator, we will now open the call for questions.

[Operator Instructions] Our first question comes from the line of Roger Song with Jefferies.

Great. Congrats for the data. A couple from us. So maybe the first one is, can you give us a reminder if you have disclosed that is the correlation between the NBAA and then the norovirus infection protection coming from your -- the challenge study before because now we see the full increase from the baseline we want to just benchmark that the correlation you have reviewed before.

Yes. This is Sean. Again, I think that what we showed in that publication is that there were 2 main correlates protection to both the NBAA as well as the fecal IgA. Obviously, both of them independently correlated as well. And given that what the purpose of the study was to show that the new constructs were better than the old, we thought that the NBAA would be a very good readout from the standpoint of deciding that. And certainly, we do see that the new constructs do behave better. And again, because of the correlations that we provided in that publication, we do think that it's critical or important that we were able to succeed in that.

Got it. And then for the next steps, you have the Phase IIb, assuming the partner, maybe just what could be the Phase IIb design before you can start the Phase III? And then second part of the question is what kind of the partner profile you're looking for? And then how is the partnering discussion have been going?

Sure. Roger, let me handle the second question and then Sean could just cover the first part. So in terms of the partner conversations, frankly, they're going well. There are a variety of potential partners who we have been in discussions with, including large multinational companies. There are some regional players as well. And one of the things that they were certainly waiting for is this data. We're excited because now we have the data, it's positive. Sean will go into more details there. But that really just sets us up for, I would say, productive conversations and also allowing potential partners to also review the data. So sorry, Sean, please go ahead.

Sure. In terms of what the Phase IIb would look like, essentially this is a safety study to get their ends up for the standpoint of having your vaccine in the final formulation as well as in dose. And we haven't disclosed the exact number. And obviously, we do it with placebo, but essentially, it's in the hundreds, not in the thousands over.

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

Congrats on the data. Maybe a few questions from us. First, I'm just wondering, given the pretty robust data, what is your prediction that the immunogenicity data may translate to reductions in like norovirus infection and also the AGE events compared to the first-generation product?

Obviously, it's a good question. Keep in mind, one of the reasons why we chose NBAA as a readout is it was correlated with protection in that norovirus challenge study that we published earlier this year. We do think it's an important parameter to monitor. Keep in mind, in that challenge study where we were hitting people with a very, very large dose of norovirus, we were able to show a 30% relative reduction in infection.

Obviously, if your titers go up on the NBAA, we think we do better in the challenge study. And in the field because you're not bombing people with so much norovirus, we do even better. So we can't really predict, obviously, completely what would happen in the field study, but our feeling is the combination of field study plus using these better constructs, it would translate to much better protection over.

Okay. Got it. And just secondly, just seems like both doses are very effective. So any thoughts on which dose are going to take forward to the Phase IIb.

Yes. I think that some of it will depend on the partnering discussions we have. Obviously, both doses did quite well. It probably is showing that even at the lower dose, you're kind of getting close to the maximum response. So yes, it's a good question. I mean you might lean into the high dose just because you got a little bit better response, but I will -- I'm going to say that we'll have to -- we'll wait to see what the partners think as well over.

Okay. Got it. And just lastly, just any color you can share around the -- maybe the fecal IgA data, that would be great.

Yes. At this point in time, one of the things we wanted to do is essentially look at both fecal IgA as well as NBAA, but we thought that because of the timing, we could get an answer on the dose as well as the constructs very quickly, just with NBAA, and that's what we need to -- and because that data was available, we were able to disclose it.

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

Congrats on very strong results here. So while you don't have a placebo arm here, but if you were to compare the second-generation norovirus candidate, immunogenicity versus, say, placebo, could you just put in context what the fold increase would look like on the NBAA primary efficacy evaluation here? And I guess the second part to the question that was asked before, what would your expectation be in that proportionality of serum or fecal IgA and also serum IgG. I don't know if you've looked at that, given the fold increase you're seeing on titers here. By our math, you're like 12-fold higher on GI.1 versus placebo. Like would you expect a similar proportionate increase for the IgA and also maybe IgG, where obviously we can draw some comparison to the mRNA approach?

Yes. There's a lot packed in your question. So I'll try to bring it out as best I can. Obviously, we think fecal IgA is important from a mechanistic standpoint. We do know that there's a -- with the mucosal vaccine, you do get some read-through into the sera, which is why the NBAA turns out to be very significant from the standpoint of looking at protection. At this point in time, obviously, the key thing about this experiment was to essentially decide whether the new constructs were better than the old. We have enough data from the NBAA to basically make that a definitive statement about it. And in fact, it was statistically significant.

At this point in time, one of the things we're going to do is we're working on getting all the data complete for this and then published as well as present this data. So we haven't detailed out if you're asking how does a placebo do? Well, obviously, if you give a placebo tablet to people in norovirus world, there's not really an increase in those titers. So you can't -- you don't see an increase whatsoever. And again, as you could probably go back to our earlier papers to see what the background titers are in people, but they certainly vary between something in the order of 10 to 100 in terms of the background.

So anyhow, like I said, we'll have more data coming out in presentations as well as the publication later this year.

That's helpful. And then what's the outstanding work remaining? I know you got some started with the regulators on establishing correlate protection, but just curious what maybe next steps are? And if there's a prespecified kind of analysis you can build in your Phase II. And again, your Phase II, you are saying would be a dose-ranging study versus placebo and not a challenge study, right, for you to make the case to go into a Phase III next year?

Yes. The key thing from the standpoint of the Phase IIb is to get enough safety data against placebo. So -- and again, we haven't specified exactly how many, but it's in the hundreds so that you have confidence that in your final formulation that you're going to use going forward that you, again, have a big enough safety database to feel good about the next steps and having these discussions about what takes for approval.

At this point in time, we're not proposing a new challenge study and this Phase IIb would be effectively a safety study with immunogenicity as well. And again, you could -- it's not powered to look at efficacy in the field. But if you had certainly enough outbreaks, you could certainly monitor that. And again, we still haven't published or disclosed what our exact design of that Phase IIb study is, but the primary endpoint of that study is to look at safety versus placebo in enough subjects that you have confidence that what you're doing is not going to cause any harm.

Okay. And lastly, any medical conference you're targeting for a full data presentation in the second half?

Yes. I think the 2 conferences that we're going to plan on going to this year, we're going to go to the calicivirus conference, which essentially talks about norovirus ad nauseam with all the leading experts. And then there's a World Vaccine Congress in Europe, which is in Amsterdam this year.

Mr. Berg, I'll turn the floor over to you for the written portion of the Q&A.

Okay. First question is for Sean. Why do you believe there was statistical significance for the higher dose cohort, but not for the lower dose cohort?

Yes, it's a very good question. Well, the key thing is that there were small improvements in the antibody titers at the higher dose that led to significant p-value. Again, keep in mind that both higher and lower dose cohorts of the new constructs did have higher antibody titers in the first-generation. It's just that the higher dose had a slightly improved response and therefore, was able to get a better -- a significant p-value, but both did pretty well given the size of the study.

Okay. Another question for Sean. Were there any common side effects?

Yes. Just to keep in mind that our detailed safety data is still being compiled. I can tell you across the 3 dosing arms and post dose, solicited symptoms were consistent with our legacy studies, and there were no vaccine-related serious adverse events nor dose-liming pharmacotoxicity.

Great. Another question for Sean. How do these data compare with pure norovirus data currently in clinical development?

Yes. Obviously, this is a Phase I, and we are looking at just essentially our NBAA assay. Keep in mind, our NBAA assay is a blocking titer assay, which is similar to the HGVA titers that other companies are using. However, it's not the same. So it's hard to compare across. We don't think it's the right way to look at these things. Further, keep in mind that the composition of the serum antibodies that we get is really higher in norovirus-specific IgA due to the mucosal deduction.

And we do think that, that makes a difference and it makes it -- our response is going to be much more potent.

Okay. Great. A question for Steve. What is the latest on partnership discussions?

Yes. So our partnership discussions continue to go well. They have been waiting for this data. So we're obviously very excited to be able to release this data. And this will actually set the tone for the ongoing discussions. And as I stated earlier, there are quite a few partners interested, and they range from a variety of types of companies, right, to include the large multinational companies to some of the regional players.

There's also companies outside the United States who have expressed interest in licensing the asset as well. So we will be very busy in the upcoming weeks as we move forward and share this data.

Another question on partnering for you, Steve. Are partnering discussions exclusive to noro? Or would you consider a partnership that also includes either COVID or other vaccines in the portfolio?

Yes. So in terms of COVID, as a reminder, we do have that our current COVID program has -- is fully funded to the tune of $460 million with our Project NextGen award, which we're excited and it's moving forward very well with dosing and enrollment. We've been spending a lot of time for obvious reasons talking to partners on norovirus, and that largely is the primary discussion. But it's also safe to say that every partner is different and the discussions of a few have included, what about other assets in your portfolio to include COVID as well as even some discussions on our HPV therapeutic.

More importantly, this data shows some great progress that we have made with the second-generation constructs. And I think as a result, it really does sort of heighten the awareness as well as the excitement for the platform in itself. So bottom line, norovirus is certainly taking most of the discussion, but also the rest of what we're working on has also been bringing some attention.

And a final question for Sean is along similar lines, but scientifically, is there a read-through with the data of the second-generation constructs today for the COVID-19 trial or for the preclinical programs?

Yes. Well, of course, the technology we employed with the second-generation norovirus constructs is the same as we've implemented in the COVID-19 Phase IIb trial as well as throughout our platform. We do expect that we will see improvement immunogenicity in that COVID-19 study with these new second-generation approaches. So we're very excited about that potential.

Okay. Thank you. That is all the questions we have at this time. Operator, can you close this out, please?

Thank you. This concludes our Q&A session, and thus concludes our call today. We thank you for your interest and participation. You may now disconnect your lines.