Annual General Meeting Transcript - VXRT 2025-11-18

Operator

Greetings and welcome to the Vaxart Stockholder Fireside Chat Conference Call. A question and answer session will follow management's opening remarks. Individual investors may submit written questions to ir at vaxart.com. As a reminder, this conference is being recorded. I would now like to turn the webcast over to David Carey, FinPartners.

David Carey, Head of Investor Relations

Thank you, Operator. Good afternoon and welcome to today's call. Joining us from VaxArt are Steve Lowe, Chief Executive Officer, Dr. Sean Tucker, Founder and Chief Scientific Officer, Dr. James F. Cummings, Chief Medical Officer, Jerome Grassman, 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 factor section of VACSART's most recently filed annual report on Form 10-K and also on other periodic reports filed with the SEC. VACSART undertakes no obligation to update any forward-looking statements after the date of this call. I'll now turn the call over to Stephen Lowe. Steve?

Stephen Lowe, CEO

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 2B 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 2B program and leveraging Dynavax's deep expertise in vaccine development and commercialization to help advance our oral vaccine candidate. it. Turning to norovirus, in June, we reported positive phase one 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 offers 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 timeline 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. Thanks, Steve. We'll now take questions

David Carey, Head of Investor Relations

directly from investors. And as a reminder, participants may submit questions through the webcast portal or email them in at ir at vaxart.com. 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

Stephen Lowe, CEO

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 number one, they're a proven vaccine company. They have taken a vaccine all the way through a phase three 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 2B trial. And once we get to results at the end of Phase 2, should Dynavacs want to proceed, we now have someone who is willing to fund a Phase 3 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.

David Carey, Head of Investor Relations

Okay, thanks. Next question is from several investors. Are you able to use the funds from Dynavex to pursue other programs, or is that $25 million fully devoted to COVID development? And then a follow-up from Anil Kay, will the cash provided allow you to move forward with New Arnold Phase 2, or will you still need a partner to fund that? And, Steve, I'll turn that over to you.

Stephen Lowe, CEO

Sure. I'll take the first part of the question, and then I'll hand it over to Jerome to take the second part of the question. So as a reminder to folks in the audience, the upfront economics on this deal is, number one, 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 two to provide the opportunity for DynaVacs to opt in for the next step. In terms of the other funding, et cetera, let me turn that over to Jerome.

Jeroen Grasman, CFO

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 two 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 NORA program. I'll leave it at that and hand it back to you, David.

David Carey, Head of Investor Relations

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

Ed Berg, General Counsel

Sure. Thanks, David. As to the question, so we're always looking to move all of our programs forward, and our focus on neurovirus 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 Dynavacs, they ultimately determined that they were interested in our COVID program and taking it forward after the results read out on the Phase 2B 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 assuming that they elect to develop this asset. And then finally, with regard to neurovirus, as Jerome said, there are ongoing discussions.

David Carey, Head of Investor Relations

Okay. Thank you, Ed. And 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.

Stephen Lowe, CEO

Yes. So yes, there continues to be interest in the norovirus asset. Certainly the announcement of the Dynavacs 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's been getting some extra attention as well, if it's fair to say.

Sean Tucker, Analyst — Other

Yeah, sure. Again, the platform data to date, and note we have made several scientific presentations about the clinical data recently, it's been positively received. I'd love to think it was my presentation skills, but realistic, you know, data, good data speaks volumes. The recent Dynavac 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 study their 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.

David Carey, Head of Investor Relations

Okay. Thank you, Sean.

David Carey, Head of Investor Relations

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 over to James.

James Cummings, Analyst — Other

Hey, thanks, David. You know, 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 KP2 cohort, we believe our trials size to produce a robust data set. You know, based on our statistical calculations, we believe the current trial, it's 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.

David Carey, Head of Investor Relations

Okay. Thanks, James. Next question is from Ann M., 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.

James Cummings, Analyst — Other

Thanks, David, and thanks, Anne-Em, for your question. You know, there's been no significant changes to the Phase 2B trials during the government shutdown. Now that we've completed enrollment, we're focused on generating top-line data from both the 400-participant Sentinel cohort and the over 5,000-participant KP2 cohort. And we've been engaged with our BARDA partners all along the way.

David Carey, Head of Investor Relations

Okay, thank you. The next question is from Anil Kay. Why was the low-dose chosen for the COVID phase 2B trial? Do you have any concerns with the mixed IGA results of low-dose in the next-gen NORA 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.

James Cummings, Analyst — Other

Okie dole. Well, thanks, Adil. So, you know, our prior phase two 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, currently there's no approved norovirus vaccine used in the general population that could be boosted.

David Carey, Head of Investor Relations

Okay. Thank you, James. Another question from Anil Kay. 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

Sean Tucker, Analyst — Other

question, I'll turn it over to Sean. Thanks, Anil Kay, 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'd also expect more protective

David Carey, Head of Investor Relations

responses against a respiratory pathogen like covid19 thank you sean next question is from

David Carey, Head of Investor Relations

Stephen 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 timeline perspective? And Steve, I think you've

Stephen Lowe, CEO

answered that a little bit, but any more color to add there? Sure. And first, hi, Stephen. We certainly want to have a partner agreement for norovirus. You know, in the same light, It's got to be an agreement that is also beneficial to VaxArt. So, you know, that's an important aspect of it. And, you know, at the same time, as we talk to potential partners, they may have a different timeline than us. You know, they may want to see more data, which Sean's always and Sean and his team are always generating. So, again, I would just say that, you know, it's difficult to put a timeline on that, but in answer to even the prior question, you know, 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, you know, their own timelines.

David Carey, Head of Investor Relations

Thanks, Steve. 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 2B top-line readout? And which endpoints will be most critical for the Dynavac's decision point and FDA discussions? And James, could you please answer that one?

James Cummings, Analyst — Other

Sure. Well, in terms of top-line 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.

Stephen Lowe, CEO

Yeah, in terms of just, again, based on our conversations with Dynavax, we get to an end of phase two. And so the end of phase two, exactly what James had mentioned, you know, those are part of the decision points that Dynavacs will look at as they evaluate what to do next. And I also want to say that, you know, certainly in the discussions and prior to completing the agreement, Dynavacs, 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, you know, we have a well-respected, reputable vaccine company who has been successful, take the time to evaluate our platform and certainly come out with, you know, we should partner with VaxArt. So that's certainly something we see as a positive.

David Carey, Head of Investor Relations

Okay, thanks, Steve. Okay, 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.

Sean Tucker, Analyst — Other

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, you know, 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, you know, 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.

David Carey, Head of Investor Relations

Okay. Thanks, Sean. Next question is from Mohamed K. While awaiting a partnership, should in fact start independently initiate the FDA phase 2A clinical trial for its norovirus vaccine with a modest cohort of 80 participants? And James, I'll turn that over to you.

James Cummings, Analyst — Other

Hey, thanks. And thanks, Mohamed, for the question. You know, 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. Okay. Thank you,

David Carey, Head of Investor Relations

James. Here's a follow-up question from Mohamed Kay. Given the strong pre-clinical results of Vaxart's ADN 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.

Sean Tucker, Analyst — Other

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

David Carey, Head of Investor Relations

to move this forward. Okay. 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.

Stephen Lowe, CEO

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 Dynavac. 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, you know, as well, I think what has occurred, as we've seen in the third quarter, when we left NASDAQ, You know, 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, you know, 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, you know, move forward as such.

David Carey, Head of Investor Relations

Okay, thanks.

Ed Berg, General Counsel

I'll just add a little. Sorry. 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 a concern for institutional investors. And, of course, we've had more positive news, but we're now on OTC. And while some, 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.

David Carey, Head of Investor Relations

Thanks, Ed. 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 site. 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.

Ed Berg, General Counsel

So I talked briefly about it already. Some of them have rules that preclude them. But also, you know, 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 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 share the disappointment of our investors that we really haven't seen that yet.

David Carey, Head of Investor Relations

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

Ed Berg, General Counsel

so uh first 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 um 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

David Carey, Head of Investor Relations

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

Sean Tucker, Analyst — Other

Yeah, I mean, I think that 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, you know, 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 NTERC. pathogens in humans. And, you know, we're anxious to see if we can move things forward on other indications, for example, bacterial or I would say oncology targets.

David Carey, Head of Investor Relations

Thank you, Sean. The next question is from Piyush G. And apologies if I mispronounce your name, but are you planning to re-uplift onto NASDAQ? Steve?

Stephen Lowe, CEO

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's 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, you know, 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.

David Carey, Head of Investor Relations

Thanks, Steve. 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?

Stephen Lowe, CEO

Yeah, so a very similar answer to what I said earlier. At the present time, we're not putting out anything to stockholders or 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.

David Carey, Head of Investor Relations

Okay. Thank you. Next question is from another question from Anil Kay. Have there been any discussions with a partner or BARDA on the flu vaccine given the avian flu preclinical results for the NextGen product. And I'll turn this over to James. James, you may

David Carey, Head of Investor Relations

be on mute. Hey, thanks so much. So, you know, in terms of discussions with BARDA, we have

James Cummings, Analyst — Other

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 turn that over to the business team to discuss that piece. Yeah, thanks, James. From a BARDA perspective,

Stephen Lowe, CEO

what is positive about our relationship is that we do have a relationship and, you know, BARDA continues to fund the phase two COVID trial. And I think with that partnership, they are very aware of what we can do on our platform, and, you know, as a result, you know, 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, you want to add to that? Well, I think that because there's been

Sean Tucker, Analyst — Other

some recent, you know, big deals, like for SIDARA with Merck in terms of a flu asset, 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 forward, our fluv assets forward.

David Carey, Head of Investor Relations

Okay. Thanks, everybody. Next question is from Nick S. As VaxStar 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? Or once validated, it could accelerate approvals for future candidates? Steve, do you want to take that one?

Stephen Lowe, CEO

Thanks, Nick, for the question. And your question revolves around a 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. You know, as we partner with companies that have their own antigen, you know, 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 in oral vaccine platforms. So, you know, the answer to your question, Nick, is, you know, the answer is both. And that's currently how we're moving things forward.

David Carey, Head of Investor Relations

Thanks, Steve. Next question is from Timothy G. What is the time frame for DynaVax to purchase shares in VaxArt? Jerome, could you please take that one?

Jeroen Grasman, CFO

Yes, thank you. And 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, limiting the dilutive impact to our current shareholders, which I know is very important to everyone.

David Carey, Head of Investor Relations

Thanks, Jerome.

David Carey, Head of Investor Relations

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

Stephen Lowe, CEO

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 J.P. Morgan conference. And I can say that, you know, schedules are filling up already. So I think we're happy that we continue to have opportunities to meet with, you know, investors. You know, at the same time, you know, 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, you know, 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

David Carey, Head of Investor Relations

not on NASDAQ. Okay. Thanks, Steve. And the next question comes from Keith O. And Steve actually answered a little bit of this question. But will VaxR commit to more fireside chats with a regular cadence? And what would that frequency most likely be? Jerome, do you want to take this one?

Jeroen Grasman, CFO

Sure. Yeah. So I think it's, as you recall, I guess the most recent interaction was in August We had a fireside chat, and we committed at the time to provide regular updates. I think in this session, 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.

David Carey, Head of Investor Relations

Thanks, Jerome. The next question is from Diane H. Would a Phase 3 against a placebo be able to run concurrently with the observation of the 5,000-person Phase 2B trial in hopes of a product for the 2026 season? If not, why? And, James, I'll turn that one over to you.

James Cummings, Analyst — Other

Thanks, David, and thanks, Diane. You know, we would wait until the end of the Phase 2B trial when we have that data package to have an end of Phase 2 meeting with the FDA. That meeting will then help inform us of some of the particulars of what that Phase 3 trial would look like.

David Carey, Head of Investor Relations

Okay, thanks, James. 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

Sean Tucker, Analyst — Other

one over to Sean. Yeah, it's a very good question. Thanks for asking. But right now, we are focused on the current study in 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

David Carey, Head of Investor Relations

the read-through results on the trial may provide some guidance. We'll see. Okay. Thank you, Sean.

David Carey, Head of Investor Relations

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?

David Carey, Head of Investor Relations

Ed, could you take this one?

Ed Berg, General Counsel

Sure. So as we mentioned in the last fireside chat, if anyone has information that would help us either investigate or refer an investigation to a regulatory authority, we would encourage them to bring it forward. 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.

David Carey, Head of Investor Relations

Thanks, Ed. The next question, another question from Mohamed K. Why does Vaxar 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 Jerome, could you please take this question?

Jeroen Grasman, CFO

Sure. And thank you, Mohamed. Great question. So the ability to perform this in-house manufacturing is really essential and has been essential to secure these partnerships with Dynavacs 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 KP2 strain in the main cohort following that. These manufacturing facilities are located right here in South San Francisco and provide a very important differentiator for our company. And as Steve mentioned, it's important for our 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. We've streamlined our cost structure in 2025 while maintaining these critical differentiating capabilities here in manufacturing.

David Carey, Head of Investor Relations

Thanks, Geron.

David Carey, Head of Investor Relations

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

David Carey, Head of Investor Relations

Yes, thank you.

Jeroen Grasman, CFO

So we're pleased that the Dynavax partnership and our cost management focus that I just commented on enabled 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 particularly based on favorable market conditions, we'll consider traditional equity financing options

David Carey, Head of Investor Relations

while continuing to focus on managing our expenses very prudently.

David Carey, Head of Investor Relations

Thanks, Jerome.

David Carey, Head of Investor Relations

Next question is from William C.

David Carey, Head of Investor Relations

given the situation at HHS with some employee movement at the at the senior levels how has this impacted your partnership with BARDA and could you please take that one sure so we have

Ed Berg, General Counsel

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

David Carey, Head of Investor Relations

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

Stephen Lowe, CEO

Yes, thanks, Alan, for the question. The next milestone will essentially follow the results of our Phase 2B top-line 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 2B 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.

David Carey, Head of Investor Relations

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?

Sean Tucker, Analyst — Other

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, our new avian influenza vaccine was 100% protective against death in a really strong, robust ferret challenge model against the clade 2344B, which is 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 period form, and again, we'll be opportunistic and be glad to move that forward with the right partner. As far as HPV, we continue to explore other partnerships and funding opportunities because we certainly believe in that program, and we'd love to move it forward.

David Carey, Head of Investor Relations

Thanks, John. 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?

Stephen Lowe, CEO

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, you know, the common ask is, you know, 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. us. 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. Thanks, Steve. Next is an online question from

David Carey, Head of Investor Relations

Vic S. How supportive is the U.S. government and BARDA right at this time? And Steve, could you

Stephen Lowe, CEO

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 Next Gen COVID-19 clinical trial and the fact that the subjects are being followed and, you know, James and his team continue to have quite a few interactions. And so from our standpoint, we feel very happy that we have

David Carey, Head of Investor Relations

a good working relationship with BARDA. Thanks, Steve. 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.

Stephen Lowe, CEO

Sure. Again, thanks. Good question. I can say that Sean, James, and I have been at places like the World Vaccine Congress. And the word 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, you know, Sean, if you want to just highlight our prior good working relationship with the Gates Foundation, just for a few seconds, if you like.

Sean Tucker, Analyst — Other

Yeah, I think, you know, again, you know, 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, you know, depending on everybody's priorities, you know, there is a possibility that we will continue doing something similar with, you know,

David Carey, Head of Investor Relations

what I would call NGOs or a pharma partner.

David Carey, Head of Investor Relations

Thanks. Next question comes from Lout B. And, Sean, if you could please take this one. Does Vexart retain the right to develop the S and N constructs?

Sean Tucker, Analyst — Other

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, in clinic, we're pursuing the S approach because that was being better from the standpoint of producing better antibody responses than the S plus N. Okay. Thanks,

David Carey, Head of Investor Relations

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

Stephen Lowe, CEO

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 hardworking employees here at Backstart. I'm proud, and on behalf of the management team, we're proud to be working with them. And, you know, the whole entire management team, we talk about what's happening, but it's also our hardworking 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, you know, they worked through a tough year where there's been a lot of noise. Also, as Daron mentioned, there's 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 continue 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.

Operator

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