Vaxart Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 7, 2026

Key Takeaways

  • Positive Sentiment: Vaxart reported favorable 12-month safety data from its 400-participant COVID-19 Sentinel cohort, with no vaccine-related serious complications and generally fewer side effects than the injectable mRNA comparator. However, the cohort was not statistically powered to establish an efficacy advantage.
  • Positive Sentiment: The approximately 5,000-participant COVID-19 trial is fully enrolled, with top-line efficacy and safety data expected in the first half of 2027. A modified BARDA agreement provides $29 million for expanded safety, immunogenicity, mucosal-immunity, and genomic analyses.
  • Negative Sentiment: Vaxart ended the quarter with $64 million in cash and expects funding to support operations only into the second quarter of 2027. The company may use its available $25 million Lincoln Park equity facility while pursuing non-dilutive funding and partnerships, creating potential dilution risk.
  • Negative Sentiment: The norovirus program remains unfunded and its development timeline was removed from the corporate presentation pending a partnership or other financing. Management continues to report partner interest, but Moderna’s delayed trial and HilleVax’s prior failure add uncertainty to negotiations and the market opportunity.
  • Positive Sentiment: The company implemented governance changes under a cooperation agreement with a shareholder group, including new board committee chairs, a Stockholder Engagement Committee, a Clinical and Regulatory Affairs Committee, and a search for an additional independent director.
AI Generated. May Contain Errors.
Earnings Conference Call
Vaxart Q2 2026
00:00 / 00:00

Transcript Sections

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Operator

Greetings, welcome to the Vaxart stockholder fireside chat. A question and answer session will follow management's opening remarks. Individual investors may submit written questions via the webcast portal. As a reminder, this conference is being recorded. I would now like to turn the webcast over to David Carey of FINN Partners.

David Carey
Senior Partner of Investor Relations at FINN Partners

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 Ed Berg, Senior Vice President and General Counsel. Before we begin, I would like to remind everyone that during this conference call, Vaxart may make forward-looking statements, including statements about the company's financial results, financial guidance, its future business strategies and operations, any partnerships with third parties, timing of any anticipated regulatory approvals, or that any such approval will be obtained, the company's future cash runway, ability to raise capital, and its product development and regulatory progress, including statements about its ongoing or planned clinical trials.

David Carey
Senior Partner of Investor Relations at FINN Partners

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 risk factors described in the Risk Factors section of Vaxart's most recently filed annual report on Form 10-K and 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?

Steve Lo
Steve Lo
CEO at Vaxart

Thanks, David. Good afternoon, everyone, thank you for joining us. The second quarter and recent weeks marked a pivotal period of execution and progress for Vaxart. In July, we achieved a key milestone in our phase II-B COVID-19 trial, announcing positive 12-month safety data from our Sentinel cohort. These results provided encouraging validation for the safety of our oral pill platform as we prepare to report top-line data from the approximately 5,000-participant main cohort in the first half of 2027. We were able to release this data after we finalized a contract modification with our partners at BARDA in June, which also released dedicated funding that will allow us to conduct a much deeper scientific analysis of the trial data. I want to express my sincere appreciation to our hardworking employees at Vaxart and the trial participants, clinical investigators, and study coordinators across all our sites.

Steve Lo
Steve Lo
CEO at Vaxart

The dedication of these participants and the research teams in executing a trial of this scale and advancing our needle-free vaccine makes our progress possible. From a business development standpoint, we are continuing to seek a partnership for our norovirus program and have seen continued partner interest. We are taking a disciplined approach to these discussions to ensure any next steps reflect the full value of this asset in the best interest of our shareholders. Right now, it is critical for us to focus on completing the phase II-B COVID-19 trial, which represents our most immediate value driver. In addition to our clinical momentum, we have taken important actions to enhance our corporate governance and engage openly and constructively with our stockholders, ensuring we remain strongly aligned.

Steve Lo
Steve Lo
CEO at Vaxart

Our decision to enter into a cooperation agreement with the shareholder group reflects our commitment, as well as our board's commitment to strong governance, disciplined oversight, and constructive engagement with our shareholders. As part of these governance enhancements, we reorganized board leadership and appointed new committee chairs, with Kevin Finney leading our Nominating and Governance Committee and Dr. James Breitmeyer chairing our Compensation Committee. Additionally, we are forming the Stockholder Engagement Committee and the Clinical and Regulatory Affairs Committee. We are also in the search process for an additional independent director to be added to the board, working closely with the shareholder group as outlined in our collaboration agreement. We believe these actions significantly strengthen board oversight and reinforce our commitment to shareholder dialogue. I'll turn the call over to James to walk us through the details of the COVID-19 data readout. James?

James F. Cummings
James F. Cummings
Chief Medical Officer at Vaxart

Thanks, Steve, and thanks everyone for tuning in. As Steve mentioned, in July, we were pleased to report positive 12-month safety data from the 400-participant Sentinel cohort of our phase II-B COVID-19 trial, and that's funded under BARDA's Project NextGen initiative. To help put this in context, a Sentinel cohort, it's really a smaller group of participants vaccinated first to evaluate safety before you expand to a much larger study population. This cohort served as our first direct head-to-head test comparing the safety of Vaxart's oral pill vaccine against an approved injectable mRNA vaccine. In this group, vaccines were targeted against the XBB variant of SARS-CoV-2, the virus that causes COVID-19, with 201 participants receiving our pill and 199 receiving the injectable mRNA vaccine. On safety and tolerability, which were the primary focus of this cohort, the results were very encouraging.

James F. Cummings
James F. Cummings
Chief Medical Officer at Vaxart

There were zero vaccine-related serious health complications and zero severe or long-lasting adverse events in either group. When we look at everyday side effects, our pill demonstrated a very favorable profile. The most common side effects reported with our pill vaccine were mild to moderate fatigue at about 20.9%, headache at 18.9%, and a loss of appetite at about 10%. Fewer than 10% of participants experienced really any other side effects. In contrast, participants who received the mRNA injection experienced higher rates of side effects at the injection site and throughout the body. Over 60% of the mRNA recipients reported injection site pain, 40.2% reported injection site tenderness, 35.2% reported fatigue, 33.2% reported muscle pain, and 28.6% reported headaches. Additionally, 10%-15% of mRNA participants reported also joint pain, chills, nausea, diarrhea, and arm swelling. These findings align with what we would expect from our technology.

James F. Cummings
James F. Cummings
Chief Medical Officer at Vaxart

Taking a pill eliminates the injection site pain. There's no injection. Local swelling, systemic discomfort, these things are typically associated with needle-based mRNA vaccines, but not a pill vaccine. Regarding COVID-19 cases in this 400-person study, 33 participants in the oral pill arm and 30 in the mRNA arm experienced symptomatic COVID-19. That means they had the typical symptoms of COVID-19. In each group, 12 participants had asymptomatic cases, which means they tested positive for SARS-CoV-2 virus, the virus that causes COVID-19, even though they didn't have any symptoms. It's important to emphasize that this 400-person sentinel group, this was intentionally designed to understand really only the safety profile, to get a safety signal, rather than to scientifically prove a statistical difference in protection between the two vaccines.

James F. Cummings
James F. Cummings
Chief Medical Officer at Vaxart

Our main study cohort, which consists of about 5,000 participants vaccinated against the KP.2 variant, is large enough to distinguish between random events and events related to the type of vaccine administered. This main group is fully sized and powered to provide statistically significant answers on both safety and relative efficacy. Thanks to our June contract modification with BARDA, we are equipped to perform a much deeper dive into our trial data. This includes evaluating mucosal immunity, which measures antibody protection right where the virus enters the body, in the nose and in the mouth, alongside the broader immune and safety measures. We're actively advancing these detailed analytics, though we're not in a position to provide a reporting timeline at this time. As I mentioned, it's part of our contract with BARDA. It provides the agency with authority over all the readouts.

James F. Cummings
James F. Cummings
Chief Medical Officer at Vaxart

As Steve mentioned earlier, we look forward to reporting top-line data from the approximately 5,000-participant main cohort in the first half of 2027. I'll now hand the call over to Jeroen for the financial update. Jeroen?

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

Thank you, James. Vaxart ended the second quarter of 2026 with $64 million in cash equivalents, and short-term investments. Based on our current operating plan, we continue to project that our capital will fund operations into the second quarter of 2027. Revenue for the second quarter of 2026 was $27.2 million, compared to $39.7 million in the second quarter of 2025. This revenue was primarily derived from our BARDA government contract, along with $2.9 million of revenue from our license and collaboration agreement with Dynavax that we signed in November of last year. Our research and development expenses were $33.7 million for the quarter, down from $49.7 million in the prior year. This net decrease is primarily due to a decrease in clinical trial expenses related to Vaxart's COVID-19 vaccine candidates, a reduction in personnel costs, facilities costs, as well as preclinical manufacturing costs.

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

General and administrative expenses were $6.6 million for the quarter. Overall, Vaxart reported a net loss of $13.5 million, or $0.06 per share, compared to a net loss of $15 million, or $0.07 per share, in the second quarter of 2025. Additionally, our $25 million share purchase agreement with Lincoln Park Capital remains available, giving us flexible access to capital at our sole discretion. We remain focused on disciplined financial management and evaluating non-dilutive funding options such as government grants and non-dilutive partnerships as we work towards our upcoming clinical milestones. I'll now hand the call back to David to take your questions.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, Jeroen. We've received many questions from shareholders in advance, and we've grouped those questions by topic. We'll take the pre-submitted email questions first, and then we'll move to live questions that are coming through the webcast portal. The first set of questions are related to COVID-19. James, could you please take this question? It's, when should shareholders expect efficacy on the 5,000-participant study? When should we expect comparative immunogenicity data from the approximately 400-subject COVID study? Two questions there. Will data include meaningful comparisons with currently available mRNA vaccines?

James F. Cummings
James F. Cummings
Chief Medical Officer at Vaxart

Thanks for the question. We expect to release the top-line efficacy and safety data from the complete study set, comprising the 400 participants in the Sentinel safety cohort and, as I mentioned, the approximately 5,000 participants in the main cohort in the first half of 2027. As far as the immunogenicity data from the 400 or so Sentinel cohort, the phase II-B trial was structured under an award from BARDA. A core mandate of this BARDA-funded trial design is to directly evaluate the relative efficacy, safety, and the immunogenicity of Vaxart's oral pill vaccine against an active, approved injectable mRNA vaccine comparator. We're actively advancing this process, though we aren't right now in a position to provide a specific reporting timeline.

James F. Cummings
James F. Cummings
Chief Medical Officer at Vaxart

This is due in part, as our contract with BARDA, as I mentioned, provides the agency with the authority over the time and the content of all the readouts we release.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, James. Sean, could you please take the next question? With COVID rapidly mutating and, in some circumstances, substantial mutations, like from XBB to KP.2 to XFG and Cicada, can IgA handle mutations with that much variance?

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

Yeah. Thanks for the question. We know that IgA has a greater ability to handle variance than IgG, and we know our platform does elicit these strong mucosal IgA responses. As everyone knows, we previously reported that our oral COVID-19 vaccine demonstrated broad cross-reactivity with a variety of SARS-CoV-2 variants, but also with other coronaviruses. We really do have confidence that our approach is going to work out better than an injected vaccine. Of course, ultimately, we will find out a lot more about the performance of our vaccine when we look at the analytical data for both the Sentinel and the main cohorts of the COVID study that is currently enrolling, and actually finished enrolling and still in progress. There's a large amount of data we're going to get from because the study is so large.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, Sean. Next question back to James. Do you know how many total cases of COVID, both symptomatic and asymptomatic, have been seen in the larger 5,000 group so far? I know we don't have the details yet as they are still blinded, but just curious if you know the total with positive COVID infection.

James F. Cummings
James F. Cummings
Chief Medical Officer at Vaxart

Thanks, David. Thanks for the question. We're still monitoring subjects that are accruing cases in that 5,000-person cohort, as I mentioned. Our plan is to provide that information as part of the release of data on the main cohort in 2027. As a reminder, and again, not to be a broken record, BARDA approval is required before any release of information, and we're aligning with BARDA on each data release.

David Carey
Senior Partner of Investor Relations at FINN Partners

Okay. Next question for Sean. Back to you, Sean. Dr. Cummings previously stated that for the COVID vaccine, that low dose and high dose produce similar IgA. Was that based on the original phase I trial data from 2020/2021? Was it based on modeling to estimate the IgA response under different doses? Clearly for noro, there was a material difference.

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

Thanks for your question. Earlier trials of our COVID-19 oral vaccine were used to guide dosing. For example, we found that the low dose and the high dose of our oral pill vaccine had a similar immune response when used as a booster in people that have previously received an mRNA vaccine. Obviously, everybody in this study has already received an mRNA vaccine at some point in their past. We think that was a good guide for dosing. We'll have better insights in the immune response of the current vaccine once we've analyzed the immunological data. That will help us determine appropriate immune correlates. Again, guide us to whether a higher dose should be explored.

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

I would point out when the question about the norovirus study that, yes, we did see a statistical difference between the old norovirus construct compared to the next generation norovirus construct when you looked at just the high dose in the phase I study. Again, this was a study we ran in 2025. Again, that was great. We know that the new constructs are better. The difference between the high and the low dose of the next generation norovirus constructs wasn't statistically different, even if there was a slight numerical difference. These difference could be just resulting from randomness in human-to-human variation rather than true dose effect. I should also point out. Remind you that dosing for one vaccine isn't necessarily going to be the same from each disease target, even if the vaccines are built on the exact same platform.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, Sean. James, back to you. Even though it wasn't powered for efficacy, are you surprised that Vaxart's improved next-gen product produced similar infections with mRNA, where we know it wanes quickly and is more lock and key, as you have stated? What happened to Vaxart's product providing cross-reactive immunity and more durable immunity?

James F. Cummings
James F. Cummings
Chief Medical Officer at Vaxart

Thanks. First off, from an efficacy standpoint, our pill vaccine candidate compared very favorably to an approved injectable mRNA comparator, demonstrating similar efficacy in this sentinel cohort. That said, this overall data set, it's exciting. It's important to emphasize that this 400-participant group was primarily designed to evaluate safety, and it really lacks the statistical power, as I've said, that's required to draw definitive conclusions about how efficacy or cross-reactive immunity is present in this study. Assessing true mucosal protection and long-term durability, the second part of your question, David, requires really a much larger clinical trial population monitored over time. We're going to gain some greater insight into the duration of response, the broad cross-reactivity, and the relative efficacy or comparative efficacy, once we receive and we analyze the complete data readout from the main approximately 5,000-person participant cohort.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thank you, James. Here's another question for you. The release of the sentinel cohort data took longer than management initially anticipated. As you look ahead to the full phase II-B efficacy readout expected in the first half of 2027, are you confident that the processes and agreements with BARDA are now in place to support a timely release of those results?

James F. Cummings
James F. Cummings
Chief Medical Officer at Vaxart

Thanks for the question. The delay of the sentinel cohort was primarily driven by standard BARDA partnership protocols, which require the initial data package to flow through government review, as well as modification of our contract, I mentioned a little earlier, to reflect the scope of the trial following the pause in stop work orders. With these foundational protocols and contract framework fully established, our team is applying really those key operational learnings directly to the execution of this main study. That said, it's important to reiterate that under the terms of the contract, BARDA has final approval on timing and content of all readouts. Integrity of our data is critical. Really, it's why it's so important we follow those protocols. We have an experienced team that's managed this process, and we will continue to do so.

James F. Cummings
James F. Cummings
Chief Medical Officer at Vaxart

The main study of about 5,000 participants is already fully enrolled and actively being advanced. I look forward to reporting top-line data in that first half of 2027. We're all fully focused on achieving this core milestone as fast as we can for such a large and complex study with the highest fidelity data possible.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, James. Sean, the next question is for you. It appears your oral COVID vaccine may have use as a therapeutic in long COVID. Is this something worth considering? A large percentage of the population is affected. Have you ever sat in your car at a turning arrow and missed the turn because of a driver ahead of you had a lack of attention? Well, working on this as a therapeutic may ease the acceptance requirements.

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

Thanks for your question. It's certainly very interesting to us. Again, we're very bullish about the potential of our COVID vaccine for treatment of long COVID. The causes of long COVID continue to be evaluated. There is evidence that some people experiencing long COVID may have low levels of viral replication in small pockets of replication within their body. It's not clear why the immune system can't clear the infection from the rest of the body while leaving these small pockets. We do know that there's been some studies out there that said they exist. We do know these pockets can occur in the intestinal tract. Our oral intestinal targeting approach could potentially do something to address those small pockets of replication.

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

I also would point out, of course, this is clear that this is just a hypothesis. We would need to conduct another clinical trial of people with long COVID and determine if our oral pill could eliminate or do something to improve those people's lives. Ultimately, as I pointed out before, Sanofi holds the final decision on whether they move on this and advance into a clinical trial specific for your long COVID.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, Sean. Let's move on to norovirus. A few questions, actually, several questions came through. Steve, can you take this question? With Moderna's norovirus program currently on hold and Vaxart's having generated encouraging safety data from approximately 400 participants, have discussions with potential pharmaceutical partners become more active? Without disclosing confidential information, can management provide a sense of the valuation range being discussed for a partnership?

Steve Lo
Steve Lo
CEO at Vaxart

Thanks. I'll go ahead and address the Moderna's norovirus program first. What we saw in the news was that Moderna needs another season to complete enrollment in their trial, so it's not on hold, but it's been extended essentially for another season, which of course extends the timing of the trial. From our standpoint, it's a mixed blessing. On one end, we see them as competition and the sooner we can get our phase II trial to move forward, the closer we can stay close to them in terms of being in the marketplace. Having them delayed, of course, provides a little bit of a competitive advantage, so that's a positive. The not so positive, which again, we'll do our best to always mitigate, is that now we have another data point in the norovirus marketplace where there was a company that failed, HilleVax.

Steve Lo
Steve Lo
CEO at Vaxart

There is Moderna, which is extending its timeline. When we're talking to potential partners, they also keep that in mind as well when they're looking at, is this a good opportunity? In terms of the question around the valuation range, we normally don't communicate that, primarily because we don't want to negotiate against ourselves. I will say that we, as Vaxart, see high value in norovirus, which is why we continue to have discussions with potential partners. We think this is a huge unmet need, and as a result, we still continue to promote this to other potential partners.

Steve Lo
Steve Lo
CEO at Vaxart

The Moderna data as well as the fact that we do have the positive safety data with the Sentinel cohort, I'll say that it's allowed us to reach out to companies that, let's say, haven't responded in quite some time, and it's helped us to at least make them aware of here's the latest data if you haven't been paying attention. I would say in that regard, it's been helpful.

David Carey
Senior Partner of Investor Relations at FINN Partners

Okay. Thank you, Steve. The next question is kind of similar. I'll read through the entire question, and I think, Sean, if you could answer this, and then Steve, if you have any follow-up. The question is, management has previously indicated that partnering interest in Vaxart's norovirus program could increase following Moderna's interim analysis of its phase III norovirus study. Moderna recently announced that its trial did not meet the statistical criteria for early success and that it plans to enroll an additional cohort. Does management view this outcome as favorable or as an obstacle to Vaxart's competitive and partnering position?

Steve Lo
Steve Lo
CEO at Vaxart

Yeah. When I was talking earlier, as I was saying, certainly the question here is asking, is it a positive or a negative? I'll call it a mixed blessing again. From a competitive standpoint, certainly helps us. From a watch out perspective, if I am a potential partner, they're also looking and asking why it's taking so long for Moderna. They put that into their thought process when they're talking to us about how to conduct a trial in norovirus. I think Sean has perhaps a scientific or statistical view on that as well, if you want to chime in.

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

Well, again, I'd love to speculate. I'll just tell you a little bit of what I'm thinking. Obviously, we don't have a copy of Moderna's statistical analysis plan. We don't exactly know why they failed at the interim analysis. We do know that they are continuing the study. If so, what is possible and what seems likely to me is that they saw some efficacy. They didn't meet some pre-specified endpoint. I think the continuation of this study is a positive step because they see value in this indication and there's a reason to go forward. As I've said many times before, we believe that intestinal antibodies are important for protection against norovirus. We know our oral tablet's going to do a better job of eliciting these than an injected vaccine. We're really bullish that our vaccine could potentially provide better efficacy than Moderna's vaccine.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thank you, Sean. Steve, another question for you. Why has the norovirus timeline been removed from the corporate slide deck? Why is the program not mentioned in the quarterly business update?

Steve Lo
Steve Lo
CEO at Vaxart

Yeah. On the second part of the question, the reason why it may not have been in the quarterly business update is we have a lot of good data to share on COVID, we wanted to highlight that because that's the near term and of course, the agreement with BARDA. That's the reason why we were focusing more on COVID. In terms of the norovirus timeline, the other thing that we want to be very transparent about is we are continuing to promote this opportunity to potential partners. It is work in progress, and because it's work in progress and the fact that we have not secured funding, and we'll look for non-dilutive funding as well, not just potential partner funding.

Steve Lo
Steve Lo
CEO at Vaxart

On top of that, since we don't have funding, I think it's premature for us to put down when the start is of that phase II study because it is contingent on funding. That's the reason why the corporate deck has now been updated.

David Carey
Senior Partner of Investor Relations at FINN Partners

Okay. Thank you, Steve. Pivoting onto a couple questions related to BARDA. James, could you please take this one? What additional analysis is being performed with the $29 million in additional funding from BARDA, and why was it not assumed at the outset of the trial versus adding it in on prior to unblinding? Did Vaxart request the $29 million, or did BARDA request additional analysis and Vaxart said it would cost $29 million?

James F. Cummings
James F. Cummings
Chief Medical Officer at Vaxart

Thanks for the question. The $29 million released through the BARDA contract modification funds final trial execution and expands exploratory safety, immunogenicity, and efficacy analyses, such as deeper sub-variant genomic sequencing and extended mucosal and cellular biomarker profiling across the 5,000+ participant main cohort. Some of the analytical work was originally contemplated as a second phase after the initial data was reported. We're very pleased that BARDA has agreed to fund that work and allow it to begin even before the final completion of the study. The modification represents really a mutual agreement. BARDA required high-resolution exploratory data to validate whether or not oral mucosal technology offers unique advantages under its Project NextGen mandate, and Vaxart established the operational budget and the $29 million requirement to complete the trial and deliver those comprehensive data sets. I hope that answers your question.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, James. Sean, next question for you. Management often talks of seeking non-dilutive funding and did an excellent job finding that with the Dynavax partnership. Shareholders often see government-sponsored RFIs and grant applications that would seemingly be a strong fit for these Vaxart pipelines. Can you confirm if Vaxart actively participates in these RFIs, or if additional government funding is considered unlikely until after the phase II-B?

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

Yeah. Thanks for the question. Again, Vaxart has a strong proven track record and history of being successful in securing non-dilutive funding. I would say most notably demonstrated by our substantial award under BARDA's Project NextGen. We've also been able to do projects with the Gates Foundation, and we've obtained grants with the NIH in the past. We've been pretty good about this. I assure you that we're aggressive in exploring various strategies to extend our cash runway through business development and non-dilutive funding options. The goal is to achieve upcoming clinical and regulatory milestones and maximize the shareholder value. Keep in mind, though, that we don't comment on what we're pursuing at the moment on dilutive pursuits for competitive reasons, but we do talk about the funding once it is confirmed.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, Sean. Jeroen, next question is for you. Given Vaxart's stated cash runway into the second quarter of 2027, the planned end of phase II meeting with the FDA, and the terms and decision timeline under the Sanofi contract, does management expect an opt-in decision from Sanofi before the company's current cash runway is exhausted? If not, how does management plan to finance operations to the opt-in decision point while minimizing dilution to shareholders?

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

Great. Thank you, David. Yeah, we fully agree, fully as a team here on the need to extend runway, both through that Sanofi opt-in that's referenced in this question, as well as to sort of fund progress on the promising pipeline programs that we've been talking about, norovirus, influenza, flu, and HPV as well. First focus, clearly as CFO, financial discipline is top of mind, cost efficiency and ensuring all the spending goes towards the corporate priorities and enabling meaningful milestones is our first focus from a financial perspective. As Steve mentioned, and Sean just now as well, we're exploring all options to secure incremental funding and going, I guess, from these non-dilutive funding sources, including the government, including the NGOs like the Gates Foundation, and seeking strategic industry partners for our programs.

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

The final piece I want to highlight here is that we have also still access to this $25 million share purchase agreement that we secured in the recent quarter here with Lincoln Park Capital. It's $25 million that we've flexible access to, we can access at any point that we want to on terms that I would call generally very favorable compared to a more dilutive larger raise. Back to you, David.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, Jeroen. Next question is for Sean. Has Dr. Sean Tucker or the scientific team reviewed existing preclinical or clinical sample data sets to evaluate whether VAAST-induced mucosal CD8 T-cells naturally express CD39? If Vaxart moves forward into the next clinical phase for HPV, is the plan to option A, advance the current formulation into trials while adding CD39 expression as an exploratory biomarker/endpoint? Option B, complete preclinical optimization to ensure robust CD39 elicitation prior to finalizing the clinical protocol?

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

Thanks for the question, thanks for talking up the importance of CD39, which I think is a really interesting biomarker. We didn't look at it in early preclinical studies, it's definitely something we were interested to track in future studies.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, Sean. Next question is also for you. Given Moderna's recent FDA approval for mRESVIA? What is Vaxart's take on the approval, how does this influence your flu vaccine program?

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

It's exciting. First, we'd like to say this represents an important step forward for the vaccine industry. Having more options for public health is important from our standpoint. Moderna has really proven that the market is ready for new approaches rather than just legacy flu shots. Some vaccines development may improve efficacy, convenience, or both. From our standpoint, as we advance our oral flu vaccine candidate through clinical development, we think we're uniquely positioned to deliver what we think is the ultimate end state for respiratory immunization. Needle-free, room temperature stable, mucosal protection in a simple pill.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, Sean. Steve, the next question is for you. With Dr. Breitmeyer joining the board, having an incredible background in oncology, should we expect to see an acceleration of Vaxart's HPV program in the coming months?

Steve Lo
Steve Lo
CEO at Vaxart

We're really thankful that Dr. Breitmeyer joined our board. He's a great match for us, with his extensive experience in vaccines and oncology, to name a few other therapeutic areas. As part of our game plan with the board, as I said earlier, we have formed a Clinical and Regulatory Affairs Committee. That will be part of the work of that committee in terms of looking at our whole entire portfolio, suggestions on where to accelerate, what's high value. There's a lot of inputs that go into that. Certainly with Dr. Breitmeyer on board, we'll be doing that. As well, this was also part of the cooperation agreement with the stockholder group to form this Clinical and Regulatory Affairs Committee. I also want to just take a moment and acknowledge and thank the stockholder group.

Steve Lo
Steve Lo
CEO at Vaxart

We've had dialogue. We've been interacting as a group. They've been helpful in terms of talking about next steps with how we engage stockholders. Again, just thank you for working with us on that settlement.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, Steve. Steve, another question for you. Can Vaxart discuss the projected timeline in terms of advancing the norovirus program if a suitable partnership cannot be established, and provide some additional color on the company's plan?

Steve Lo
Steve Lo
CEO at Vaxart

Sure. What we are really looking at, because as Jeroen was talking about our cash runway, it is important for us to have a partner who can fund this project to the next phase, and that is why we are spending a lot of time promoting this asset as an opportunity for partnership. If we run into some challenges around that, I will say concurrently, we have been also talking to other funding sources, non-dilutive funding sources, even governments outside the United States, just to give everyone an example. Our game plan is to continue to promote this. I will also say that you may not have as many frequent updates regarding this, and if we decide ever not to pursue this, we'll of course share that publicly as well.

Steve Lo
Steve Lo
CEO at Vaxart

There are a lot of questions that do come up in a lot of these partnership discussions, and they include market size. We may have differences in viewpoints on market size. A lot of these potential partners were also waiting for what was happening with Moderna. I think that's also being processed in their analyses. That just gives you an idea of what we're looking at as it relates to the norovirus asset.

David Carey
Senior Partner of Investor Relations at FINN Partners

Thanks, Steve. Steve, another question for you. As a CEO of a public company, what would you like to tell your long-term investors who have funded this company at times of distress and kept the lights on?

Steve Lo
Steve Lo
CEO at Vaxart

First and foremost, we do want to keep the lights on because as Sean is sitting next to me right here nodding, we really believe in the science. We want to take this as far as we can, and the great ideas that Sean has as the founder of this company, we're committed to moving that forward. I would tell the investors, stick with us. We really believe in what we're doing. We're not going to give up. Oftentimes, we do have to make tough choices, and those tough choices include what we unfortunately had to do last year, which we had to reduce costs and we had to lay off a few employees, and at the same time, we also have to keep the current employees motivated. From an investor standpoint, I'll say I'm in full agreement with everybody that we believe these assets are undervalued.

Steve Lo
Steve Lo
CEO at Vaxart

We want the stock price to go up. We're going to keep fighting, and we're going to work as hard as we can to ensure that. Our vision is the fact that as we talk to many investors sometimes, we highlight the fact that if they had a choice on whether to take an injection for a vaccine or take a pill, the investors certainly, personally would do the same thing. We are going to keep doing what we're doing. I really want to acknowledge and thank the investors for sticking with us, for being active, for asking good questions, and really appreciate your constant engagement.

David Carey
Senior Partner of Investor Relations at FINN Partners

Okay. Thanks, Steve. Actually, Steve, I will turn it back to you for any closing remarks.

Steve Lo
Steve Lo
CEO at Vaxart

Great. Let me say once again, just thanks everyone for joining us today, submitting your questions, asking the tough questions as well. This quarter marked significant progress for Vaxart with encouraging head-to-head safety data from our phase II COVID-19 Sentinel cohort, the government funding for expanded analytics, and a clear path forward towards full study results. We believe we're well positioned to demonstrate the true value of our oral pill vaccine platform. Every milestone we reach is rooted in our commitment to patients, trial participants, and public health worldwide. As we observe National Immunization Awareness Month this August, we are reminded that traditional vaccines still leave far too many barriers in place. Vaxart's driven to change that. We remain dedicated to delivering convenient, needle-free oral pill vaccines that make vaccination easier, broaden global access, and protect communities everywhere while generating sustainable long-term value for our stockholders.

Steve Lo
Steve Lo
CEO at Vaxart

I want to close by thanking our stockholders for engaging in constructive dialogue with us, as well as our talented Vaxart team for their continued hard work and passion. Thank you all for your time, and have a great evening.

Executives
    • Steve Lo
      Steve Lo
      CEO
    • James F. Cummings
      James F. Cummings
      Chief Medical Officer
    • Jeroen Grasman
      Jeroen Grasman
      CFO
    • Sean Tucker
      Sean Tucker
      Founder and Chief Scientific Officer
Analysts
    • David Carey
      Senior Partner of Investor Relations at FINN Partners
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