Vaxart, Inc. ($VXRT)

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 mothers, 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 maintain 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 package is finalized at the end of Phase II and presented 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. Thanks, Steve. 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 delaying a Phase IIb for us. That said, we are looking or looking at doing additional preclinical work and 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 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.

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

Me again, thanks. So pending a 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 of 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 immunity 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 official 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 to address 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 is secured, which can take a little while over.

Thanks, James. Next question comes from Tom G. And this is related to the 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?

I 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 has been 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 we're 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 until the end of 2026? Now that the cash runway is till 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 that 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 is for us to advance our vaccine science and bring safe, effective, and accessible solutions to the market to protect communities worldwide. Executing on that mission 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, now that we have been on the OTC exchange for, I guess, about 8 months since we got delisted in July of 2025, is that 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. Thank you, Jeroen. We have another question from Salazar S. And he asks around 12 to 18 months ago, there was considerable uncertainty surrounding vaccines. How has 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, 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 is kind of at a state of flux characterized by increased scrutiny, particularly for the mRNA vaccines and evolving public sentiment. I do want to stress that we're just not another me-too 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 to shifting domestic landscape, the global demand for effective immunization remains remarkably strong and is growing major international stakeholders, including GAVI 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. Thanks, Sean. Next question is from Tim and Tim Wright, 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. Vaxart 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. As 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 in 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 yielded a highly successful result of 100% protection with our vaccine against death, I should say, the gold standard ferret 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's question. You mentioned the possibility of advancing the norovirus program into Phase II independently, noting that some potential partners may be waiting for the 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. Thank you, Steve. 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 two, 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.

Thanks, James. 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 and 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 data is going to add the potential promise of our norovirus program overall.

Thanks, Sean. 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 expensive than what we've designed in the past, and it would just take longer to execute.

Okay. Thank you, Sean. 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 that one 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 will 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 discussions, 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 is probably important to start to get it off the ground and move it forward.

Okay. Next question is from Tanya A. Since 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, and 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's uplisting decision.

Okay. Thank you, 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 taken 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 Altesa 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 IIb, and they've received funding to advance this drug. But as to further timing, it's in their hands, not ours.

Thank you, Jeroen. 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 release. 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 has 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 find out new information, we provide it in 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 one 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 it 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 regional 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 believe 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 Ed, 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 chat. 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 are 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 a 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 say that we will continue to do that.

Okay. Thank you, Steve and Ed. The next question is from Keith O. 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 our DSMB with which we meet every other week or monthly at this point in the study. To get to the sentinel 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 writ large until the data lock in the end of the study. I hope that answers your question, Keith, and thanks for the opportunity to add some clarity there.

Okay. Thank you, James. 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 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 to sentinel cohort, the cohort XBB 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 to yield 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. Daniel, 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 one more piece. As disclosed in the 10-K, I guess, our headcount 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 headcount into a smaller footprint and take these savings. And again, the shift funding from infrastructure spend to program advancement.

Thanks, Steve and Jeroen. 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 costs maintaining expensive 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 headcount 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 manufacture 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. Thanks, Steve. 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.

Thanks, James. And Steve had a second question as well, and perhaps you can respond to this one. In the course of due diligence, did 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 revert back to the first, 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 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 is not currently active, how does the company plan to manufacture clinical-grade vaccine material for upcoming 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 Mitten 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 cost was 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 and Jeroen. 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.