Vaxart, Inc. (VXRT) Earnings Call Transcript & Summary

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.