Greetings, and welcome to Vaxart stockholder fireside chat conference call. A question-and-answer session will follow management's opening remarks. As a reminder, this conference is being recorded. I would now like to turn the webcast over to 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 F. Cummings, Chief Medical Officer, Jeroen Grasman, Chief Financial Officer, and Edward 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 process 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 Factor 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 Steve 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 timelines, our priority is the execution of our phase II-B 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 this year, we expect to report the comparative safety and efficacy data from the 5,000-subject KP.2 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. We actually have a good list of questions that came in beforehand, so why don't we dive into those first. The first question is from Salazar S.. 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 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. Yeah, thanks for the question. Yes, we continue to meet very closely with the original Dynavax team that had structured this partnership. You know, we have ongoing discussions on how the trials has progressed, et cetera. As a reminder, we maintain full operational and responsibility for the COVID-19 program until the completion of the phase II-B trial. Now as a reminder as well, that trial is funded by BARDA, so essentially it's Vaxart and BARDA to the end of phase II. After the data packages finalize 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. If they elect to move forward after phase II-B, then Vaxart would be eligible for a $50 million milestone payment. 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 II-B started for norovirus? If the FDA recommends delaying phase II-B again, what options and plans does Vaxart management have to continue trials?" I will turn that question over to James.
Thanks. Thanks, Travis, for your question. You know, the FDA has never recommended delaying a phase II-B for us. You know, that said, we are looking at doing additional preclinical work and evaluating a strain change that occurred and the circulating changes, strains, for norovirus. We want to make sure that we're fully covered with what moves forward. You know, as I said previously, the start of the next norovirus trial of phase II-B is contingent on securing a strategic partnership or other non-dilutive funding. There still remains a lot of interest, and we have been having ongoing discussions with some of our potential partners. Over.
Okay. 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. Hey, thanks. You know, 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. You know, 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. We're looking to see if we can obtain funding to further explore this novel approach.
Okay. Thank you. The next question is from Diane H.. Has there been any feedback from the government initiatives for pandemic preparedness platforms and adjuvants? I will turn this question over to Sean.
Thanks, Diane, for your question. Obviously, Vaxart has been very good about seeking out non-dilutive funding in the past. I don't have an update today on anything on the new initiatives. Keep in mind, I want to ensure to the stockholders that we are exploring all potential funding options, including non-dilutive 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, and we don't report on our efforts until we have an official agreement. Keep in mind, of course, we are very confident 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.. 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? James, I'll ask you to answer that one as well.
Okay-doke. Hey, Justin. Thanks for the question. So, you know, our team tracks a lot of different streams of non-dilutive funding, such as, you know, the initiatives, some of them you mentioned from BARDA, but there's more, and other government agencies as well as NGOs. We weigh each opportunity very carefully and engage on those that we think make sense from our time and capability standpoint. You know, that said, we only disclose 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.. This is related to sentinel cohort. Why did your timeline slip from Q1 to early Q2 for the sentinel cohort data readout? James, could you please answer that one?
I sure will. Hey, Tom. Thanks for the question. You know, as we've shared, you know, 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? You know, 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. You know, 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's that data? And Sean, I'll turn that to you.
Yeah. Again, you know, 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. Obviously, you know, when you're through the process, we have no control over it, whether it takes longer to get through the reviews and revisions and everything else, and it just takes a while that we can't predict all the time. 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 2027, I do not see any immediate need to raise cash via non-dilutive methods. Or 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 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." Jeroen, I'll turn that over to you.
Yes. Thank you. Thank you, Piyush, for the question. 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 non-dilutive fundraising options, we also need to consider other financing options to meet the needs of the portfolio. 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've been on the OTC exchange for, I guess, about eight months since we got delisted in July 2025, is that certain institutional investors have sold out of their holdings, likely because of our listing on the OTC. 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. I'll hand it back to you, David.
Okay. Thank you, Jeroen. We have another question from Salazar S.. He asks, "Around 12-18 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?" Kind of a 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?" 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 in 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 healthcare 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 a note that in contrast to the 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 P.. Tim writes, "Assuming positive COVID-19 data later this year, what would be next steps in your partnership with Dynavax and Sanofi?" Steve, I'll turn that over to you.
Great. Looks like there's some many questions on Dynavax and Sanofi, which is great. You know, happy to once again provide some more detail. Once again, you know, we're currently in phase II-B. Vaxart with the funding of BARDA is in charge of this all the way to the end of phase II-B. Once the results are out, and I'm glad that you're asking that they're you know, 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 to phase III. Once that decision is made, they take over the program. Vaxart receives $50 million for that option.
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. Bottom line is, as we get to the end of phase II data, that's when the decision will need to be made.
Okay. Thank you, Steve. Next question is from Jessica M.. She asks, "Can you quantify the expected annual OpEx savings from the lease termination effective this May?" Jeroen, I'll hand that one to you.
Sure. Thank you, Jessica, for the question. 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. 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. 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 then in March 2029.
The savings really 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 forums 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?
Great. 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 ferret challenge model. The data really did confirm that our oral pill platform is capable of eliciting a protective immune response against, you know, 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, you know, 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. Thank you. We have another question from Salazar S., and actually a similar question came in from Justin W.. 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 Moderna's results before committing. Then Justin continued, what factors would determine whether Vaxart moves forward independently versus with a partner?
Great. Okay, thanks, for the question.
Steve, could you take that one?
Yeah. In terms of just the norovirus program, you know, 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, you know, 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. For the study, we would have to look at raising capital. As a company, we look at whether this is a good time or bad time to raise capital.
As Jeroen had mentioned, right, we don't have as many institutional investors who can invest with us on OTC. It really does, at this point, leave us with continuing to look for non-dilutive partnerships. At the same time, we are monitoring what Moderna is doing, and, you know, 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. You know, 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. 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. His question is, did James just say that the data is unblinded, but BARDA and Vaxart are figuring best time to release? If that was not the case, 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 reasons for this?
Thanks for the question. You know, 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. As I mentioned in the initial question or two, you know, we can't move forward with unblinding, analyzing or releasing data without the agreement of our partners at BARDA. It's currently in that process of discussions with BARDA. Right now I remain unblinded. The team remains unblinded or rather blinded. We are blinded. Let me emphasize, we are blinded, as is BARDA. We await a thumbs 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 KP.2 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? Sean, I'll turn that one to you.
Thanks for the question. Just to be clear, you know, 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 what, you know, youngest of infants. I think the key thing about this is this passive transfer data demonstrates just how powerful the platform is for making antibodies that can be transferred to the infants through breast milk. In a comparative way of looking at this from the standpoint of Moderna, you know, there's been some, you know, publications to suggest that, you know, the, with their COVID vaccine, they were able to see transient levels in breast milk in very low levels, which is unlikely to really result in much transfer to infants.
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. Ultimately I think this data is going to add to the potential promise of our norovirus program overall.
Thanks, Sean. Here's a follow-up from Leslie P.. She asks, how soon after signing a norovirus partnership do you think you could get the trial up and running?
Yeah, 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. 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? Steve, I'll turn that one to you.
Yes. We have a range of discussions and conversations. It really depends on the folks we talk to. Yeah, 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 you know, 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. You know, there's some conversation around just do they have an antigen that would work on our platform? That's something that Sean and his team often will take a look at and evaluate. We look at it not just by asset, but we also look at it in terms of the platform itself.
Okay. Thank you. Next question is from Ernesto G.. Ernesto asks, are you trying to partner out any other programs such as avian flu? Steve, could you take that one?
Yes. The short answer is yes. You know, 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, you know, rates and so forth. You know, sometimes there's a lot of discussions and sometimes there's not. Perhaps I can let Sean.
Yeah. 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, you know, important to start to get it off the ground, you know, and move it forward.
Okay. Thank you. 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 for how long would that price need to be maintained in order to qualify for relisting? Jeroen, could you please take that one?
Yeah, no, absolutely. Happy to. Thanks, Tanya, for the question. We're glad you asked that question since we've received questions about this topic in the past and I'd like to correct a common misconception, I guess, that we only need to achieve a minimum share price of $1. We mentioned earlier that 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. While maintaining a listing on the Nasdaq requires a minimum bid price of $1, once you're delisted and you're looking for an up listing from OTC to Nasdaq, we must achieve a minimum bid price of $4 per share and maintain that until the Nasdaq's up listing decision.
Okay. Thank you, Jeroen. The next question is from Anil K.. 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." 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 two 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. The latest modification will continue to increase the dollars. 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 will take that into account. It'll increase funding, but it'll decrease the overall award.
That's probably where the confusion is taking place. We are gonna see more dollars coming in, but they're not going to ultimately be $460 million. 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 timeframe of the Altesa milestone payment is important for runway. Can we get that information? Jeroen, I'll turn that over to you.
Yes. Thank you, Diane. Appreciate the question and others as well, I guess. A little bit of context here. Vaxart originally acquired this drug through its 2018 reverse merger with Aviragen Therapeutics. 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. Once the drug reaches the market, we'll receive tiered royalties on their global net sales. 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 BioSciences, the drug is entering a phase II-B, and they've received funding to advance this drug. 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 date of release?" I'll turn that over to Ed to respond.
Yeah, thank you. I can understand the frustration, but you know, we want to give information to our shareholders, and in fact, we're required to under our filings. We do the best to make an estimate of what we think will happen in the future. Then we're very careful to say these are forward-looking statements, that we can't predict the future any better than anyone else can. We have a partner here, and we thought we had a high likelihood of making it to a release in the first quarter. In fact, if you go back to what James said, the data is ready to be unblinded, but we remain blinded. 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 effort that they are taking, and we are working closely with them. I think what we saw was a relatively small change in the delivery and unblinding of this data. Really the unblinding, not the delivery. 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. 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 were discussed and whether that engagement is focused more on research collaboration, manufacturing or regional commercialization? Steve, could you please take that one?
Yes. Justin, 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, etc. 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 we could work with some of the companies that are in Taiwan. It was just the first visit, you know, pretty early stage. I, you know, I think we'll continue some of the conversations at a future date.
Once again, it's also another example of how we do wanna look at global regional partnerships. There may be companies that have an antigen that they wanna try on our platform, etc. There's also non-dilutive funding, and so we just continue on our game plan of not limiting ourselves just to the United States, but looking at global opportunities.
Thanks, Steve. 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. Yeah. 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 timeline 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're the ones who are hopefully funding all the things that we wanna get done and the science that, you know, Sean has invented, etc. I'll turn it over to Ed, if you wanna just add some additional comments.
I think we are very careful with regard to our disclosures, and we are very thoughtful about what we need to disclose, when we need to disclose it. Of course, the idea is we're never disclosing it selectively. We're always disclosing it in a public way, in a way that is accepted by law. The entire management team has undergone training on that. I'll stop there and say that, you know, we will continue to do that.
Okay. Thank you, Steve and Ed. The next question is from Keith O.. He asks, "Can the Vaxart team discern with any degree of certainty or form a reasonable conclusion of which participant received which vaccine in the 400 sentinel cohort from the data produced from each participant to date without the data being unblinded?" James, I'll ask you to respond to that. James, are you there?
Well, I'll take the question from James.
I'm sorry I had a little technical difficulty. I just wanted to thank Keith for the question because it's, you know, it appears that there's been, you know, some, I wouldn't say obfuscation, but perhaps lack of clarity maybe on my part. Just to be clear, we are blinded, right? We remain blinded. 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 there be, right? The blind is doing what it's supposed to do. 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.. The question is: Have you considered using other technologies or antigens in the platform? Have you been approached by other potential partners by doing some data testing? 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 SARS vaccine problem and have suggested taking their antigen and putting it in our system. 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. The 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. In terms of confirming correlates or confirming efficacy or any of 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 will the employees from HQ work? This is a couple of employee-related questions. 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. 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. As a result, we'll still be working in South San Francisco, but we're consolidating into the other facilities. Again, it was a great opportunity for us to terminate a lease, decrease some of our spend on real estate, which, you know, we prefer to repurpose to other areas such as research and development. 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. This is what allowed us to consolidate our headcount into a smaller footprint and take these savings and 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. Mohamed, that's a great question because this is actually what we have been doing and have done. As Jeroen had mentioned in the prior question, we have reduced our headcount. A majority of that reduction was in the headcount in manufacturing. Let me just acknowledge, you know, we've had some really great hardworking employees and we value everything that they've done. The ones who are still on the books, you know, we work harder and harder every day. 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 smaller footprint. I'll also emphasize that our facility is here in the United States. With the Trump administration, you may be aware that there's 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 questions are from Steve S.. To a degree, these have already been asked, but I think it's important to ask again 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 timeframe 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. To go from the top, I can confirm that no member of the 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. That I can confirm. In terms of the Q2 release timeframe and whether or not that was communicated by BARDA didn't call up and say, "Hey, hold your horses. You're gonna have to wait till 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. I think, our general counsel, Ed Berg, sort of delineated what those parameters are. Ed, if you want to give any more clarity on that, please do. No, BARDA didn't just call up and say, "You're not gonna be able to present till 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. Steve had a second question as well, and perhaps you could 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?
I'll take the second question first, and then revert back to the first, right? In terms of information gleaned from blinded data, I'd say no. Let's take a look at what that means. Let me unpack it for you. The XBB sentinel cohort, we have ideas on in aggregate what that might look like, but we remain blinded. We don't know who got what. If you're trying to apply this, I think you said an immune response. We won't have immunogenicity for this initial cohort until after we have the topline tranche of data, which would be granular safety and some efficacy streams, right? The immunogenicity will come later, but again, we will remain blinded.
I don't see how that would be helpful, but that's my opinion. In terms of due diligence, you know, 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 in working forward. Steve or Ed, would you like to comment on that second piece for Dynavax?
Yeah, I'll just add. 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. So that's essentially how the clinical trial should be run. As Ed mentioned, please chime in if those results are unblinded. There is an obligation to share.
Yeah. 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 in 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, you know, what the terms would be. 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. I'll stop there.
Okay. Thank you. We're running out of time, so we'll take one more question from Daniel H.. 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 upcoming trials, including norovirus phase II and any BARDA-related work?" I would turn that over to, I guess, either Steve or Jeroen.
Yeah, I'll start first. 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. I'll just say that we have multiple options within our current footprint.
Yeah, no, that particular site was part of the consolidation effort in 2025. As you see in the 10-K, facility costs was reduced from 2024 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. It's a two-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. I will say that all the questions were very thoughtful, and we really appreciate the engagement, and you know, 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. 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.