Vaxart Q3 2026 & Fireside Chat Earnings Call Transcript

Key Takeaways

  • Neutral Sentiment: Vaxart is progressing its roughly 5,000-participant Phase IIb COVID-19 trial, with 12-month safety follow-up completed for the 400-person sentinel cohort. The company now expects main-cohort efficacy and safety results by mid-2027; detailed sentinel data are not yet available and require external lab analysis and BARDA review.
  • Negative Sentiment: Vaxart ended Q3 with $65.5 million in cash and investments, which management expects to fund operations into Q2 2027—before the anticipated trial readout. The company is pursuing non-dilutive funding but has a $25 million equity line available, which could extend runway into 2028 if fully used and would dilute shareholders.
  • Neutral Sentiment: Norovirus partnering discussions continue, but management said prospective partners are becoming more selective and diligence is taking longer; no deal has been announced. A new European patent extends protection for the oral vaccine technology through at least 2036 in 13 countries, strengthening the program’s partnering position.
  • Positive Sentiment: Vaxart reported peer-reviewed preclinical data showing 100% protection against lethal H5N1 challenge in ferrets. The result supports the platform’s potential for emerging threats, though it is not clinical evidence of protection in people.
AI Generated. May Contain Errors.
Earnings Conference Call
Vaxart Q3 2026 & Fireside Chat
00:00 / 00:00

Transcript Sections

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Operator

Greetings, and welcome to the Vaxart Third Quarter 2026 Stockholder Fireside Chat. A question-and-answer session will follow management's opening remarks. Individual investors may submit written questions via the webcast portal at any time during the presentation. 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 at FINN Partners

Good afternoon, and welcome to today's call. Joining us from Vaxart are Steven Lo, Chief Executive Officer; Mark Watson, Lead Independent Director and Member of the Board's Stockholder Engagement Committee; Dr. Rocky Bono, Independent Director and Chair of the Stockholder Engagement Committee; Dr. Sean Tucker, Founder and Chief Scientific Officer; Dr. James F. Cummings, Chief Medical Officer; and Jeroen Grasman, Chief Financial Officer. Before we begin, I would like to remind everyone that during the 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 milestones or clinical data readouts, the company's future cash runway, ability to raise capital, and its product development progress.

David Carey
Senior Partner at FINN Partners

Actual results could materially differ from those discussed in these forward-looking statements due to a number of important factors, including the uncertainty inherent in clinical development and regulatory processes and other risks 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. Steven?

Steven Lo
Steven Lo
CEO at Vaxart

Thanks, David. Good afternoon, everyone, and thank you for joining us today for our third quarter 2026 fireside chat, the fifth quarterly fireside chat and sixth overall fireside chat we've hosted. These discussions are an important part of our ongoing commitment to maintaining transparency and visibility for our stockholders. The third quarter and recent weeks have been a productive period for Vaxart across our clinical programs, pipeline validation, and corporate governance. Our primary operational focus remains executing the main cohort of our phase II-B COVID-19 trial. Following the encouraging 12-month head-to-head safety data we reported in July from our 400-participant sentinel cohort, our clinical operations and trial site teams have been actively advancing the approximately 5,000-participant main cohort. We expect to report efficacy and safety data by mid-year 2027. In addition to our clinical momentum, we have taken important steps to strengthen our board leadership and corporate oversight.

Steven Lo
Steven Lo
CEO at Vaxart

To speak more about our governance initiatives and introduce our newest director, I'd like to turn the call over to our Lead Independent Director, Mark Watson. Mark?

Mark Watson
Mark Watson
Lead Independent Director and Member of the Stockholder Engagement Committee at Vaxart

Everyone, on behalf of the entire board, I want to take a moment to directly acknowledge and thank you, our stockholders. Your ongoing support and continued engagement are fundamental to everything we do at Vaxart. We value the perspective you share with us and look forward to continuing that dialogue into the future. To that end, our board has formed a dedicated Stockholder Engagement Committee consisting of Steven, myself, and our newest independent director, Dr. Bono, retired Vice Admiral of the U.S. Navy. The committee provides an additional forum for direct engagement between the board and our shareholders, ensuring investor feedback informs our oversight of the company's strategy and execution. We are pleased to have Dr. Bono serving as chair of this committee. She has also joined the Clinical and Regulatory Affairs Committee and the Nominating and Governance Committee.

Mark Watson
Mark Watson
Lead Independent Director and Member of the Stockholder Engagement Committee at Vaxart

Rocky brings a distinguished track record of military, surgical, and public health leadership, having served as a three-star vice admiral in the U.S. Navy and is former director of the Defense Health Agency. Her focus on operational discipline makes her an ideal leader for our engagement efforts and an ideal team member with this board. I'd like to invite Rocky to share a few words. Rocky?

Rocky Bono
Rocky Bono
Independent Director and Chair of the Stockholder Engagement Committee at Vaxart

Thank you, Mark. Good afternoon, everyone. Throughout my career, whether serving as a Navy trauma surgeon, leading the Defense Health Agency, coordinating Washington State's health system response during COVID-19, or directing global health operations for Viking Cruises, I've seen firsthand the limitations of traditional needle-based vaccines. That operational reality is why I believe so firmly in Vaxart's mission. My experience leading large-scale military and public health organizations has also reinforced the importance of trust, accountability, and open communication. I believe effective governance is vital to success and starts with listening, asking the right questions, and ensuring that different viewpoints are considered as decisions are made. These principles will be central to my approach as Chair of the Stockholder Engagement Committee.

Rocky Bono
Rocky Bono
Independent Director and Chair of the Stockholder Engagement Committee at Vaxart

I intend to thoroughly integrate stockholder perspectives into our board discussions, helping keep the board connected to these priorities as we oversee management's execution of Vaxart's strategy and work to build lasting value. I look forward to engaging directly with our stockholders and working alongside the entire board to support Vaxart's long-term success. With that, I will hand the call over to our Chief Medical Officer, Dr. James F. Cummings, to walk through our clinical updates. James?

James F. Cummings
James F. Cummings
CMO at Vaxart

Thanks, Rocky, and welcome aboard. Before I get into our COVID-19 update, I would like to highlight two notable developments across our broader pipeline. First, on norovirus. In late August of this year, the European Patent Office granted a patent extending protection for our oral norovirus vaccine technology to at least 2036 across 13 European nations. This directly complements our existing U.S. patent estate. Together, they provide multi-jurisdictional IP protection through 2036, which is now integrated into our data package for active discussions with prospective partners. Second, on H5N1 avian influenza. In early October, we published peer-reviewed data demonstrating 100% protection against a lethal challenge of H5N1 avian flu in a ferret model. The ferret is widely recognized as the gold standard for preclinical work in human respiratory infection.

James F. Cummings
James F. Cummings
CMO at Vaxart

This study demonstrates the agility and modularity of our Vaxart oral platform, highlighting how we can engineer and deploy vaccine candidates against high-consequence emerging threats with real pandemic readiness. Now, turning to our phase II-B COVID-19 trial, one of the questions that we receive most often centers on the clinical timeline, specifically, what actually goes into running a study of this magnitude, and why are the clinical and the regulatory processes, why does it take the time that it does? So, to further understanding, I would like to walk you through some of the key components of a trial of this size and complexity to illustrate why a deliberate, precise approach is necessary to generate high-quality data that support the regulatory process. First, look at the operational scale. Now, we are not doing a small early safety trial of 30 or 40 volunteers.

James F. Cummings
James F. Cummings
CMO at Vaxart

This is a large-scale, head-to-head comparative trial evaluating our oral tablet vaccine candidate against an approved mRNA injection across approximately 5,000 active participants at 140 clinical sites nationwide. Building out that network, making sure every single site adheres to exact clinical standards, and maintaining consistent regulatory-grade data collection across thousands of participants, well, that requires significant coordination. Second, there is a stringent screening process. To enroll 5,000 qualified participants, our clinical teams have to screen many thousands more. Because this trial measures comparative immune responses and real-world infection endpoints against the KP.2 variant of COVID-19, every single participant must fit strict protocol criteria regarding prior infection and vaccination history. Taking the time to properly screen participants ensures our final dataset remains uncompromised and ready for regulatory scrutiny. Third, clinical timelines are fundamentally governed by required periods of observation.

James F. Cummings
James F. Cummings
CMO at Vaxart

To accurately measure vaccine efficacy, durability, and both mucosal and systemic immune responses, participants are followed over set protocol windows spanning months. These observation periods are essential to understanding how the immune system develops and sustains protection over time. The resulting clinical and laboratory data must then undergo review and source validation prior to being finalized, which takes months for a study this size. Finally, once those patient visits are completed, there are thousands of mucosal swabs and blood samples that undergo standardized laboratory processing, assay validation, strict quality checks, and regulatory data locking before any unblinding takes place. For this study, a significant share of the immunologic and viral laboratory testing is being conducted by BARDA partner labs, which helps to ensure a standardized approach and a more economical pathway for a program that is this large.

James F. Cummings
James F. Cummings
CMO at Vaxart

Because these labs operate independently of Vaxart, testing and processing timelines are also subject to their schedules and the coordination with BARDA. We are working very closely with the numerous partners to manage these dependencies and keep the program moving forward in a very timely manner. Working alongside BARDA under Project NextGen has provided Vaxart with the non-dilutive resources to execute a study of this scope and magnitude. Partnering with the federal government also means adhering to regulatory schedules, as well as BARDA's established review processes and oversight timelines. For a study of this scale intended for federal partnership and regulatory submission, rigorous execution and alignment with federal requirements must remain the priority. We have already crossed critical milestones here, including the clean 12-month safety clearance from our 400-participant sentinel cohort.

James F. Cummings
James F. Cummings
CMO at Vaxart

As we execute through the remaining follow-up windows, our team remains fully focused on delivering this clinical study, the readout by mid-year 2027. With that, I will hand the call over to Jeroen for our financial update. Jeroen?

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

Thank you, James. I will now review our third quarter 2026 financial results. As to cash position and runway, Vaxart ended the third quarter with $65.5 million in cash equivalents, and short-term investments. Based on our current operating assumptions, we continue to project that this cash balance will fund our operations into the second quarter of 2027. We continue to evaluate all opportunities to extend that cash runway. On the revenue front, total for the third quarter was $10.6 million compared to $72.4 million in the third quarter of 2025. Revenue recognized during the period was primarily driven by work performed under our BARDA Project NextGen contract, alongside ongoing revenue recognition associated with our collaboration agreement. On the R&D side, our research and development expenses for the third quarter were $22.8 million compared to $75.9 million for the same period in 2025.

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

Clinical trial expenditures primarily reflect our efforts in executing the phase II-B COVID-19 study. On the general administrative front, the G&A expenses were $5.1 million for the third quarter compared to $4.3 million in the same quarter of 2025. Finally, on our net loss, we reported a net loss for the third quarter of $17.7 million, or $0.07 per share, compared to a net loss of $8.1 million, or $0.04 per share, for the third quarter of 2025. Additionally, through September 30th, 2026, we generated $420,000 from shares issued and sold under the April 2026 share purchase agreement with Lincoln Park Capital. The remainder of the $25 million commitment under this share purchase agreement remains available as a flexible source of capital at our sole discretion.

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

We remain committed to strict financial discipline and continue to explore partnerships, grants, and other non-dilutive funding mechanisms as we advance towards our major clinical readouts. I will now turn the call back over to David to begin our Q&A session. David?

David Carey
Senior Partner at FINN Partners

Thanks, Jeroen. We will now begin the Q&A session, and as with previous calls, we have collected pre-submitted questions from our stockholders, which we have organized by topic, and we will also be monitoring live submissions throughout the webcast portal. To begin, Steven, I will direct this question to you. Do you think the recent election results will impact funding for the COVID-19 phase II-B trial, or the timing of the release of the full trial results?

Steven Lo
Steven Lo
CEO at Vaxart

Thanks, David, and thanks for the question. We do not anticipate any changes. The short answer is no. As a reminder, when we were first awarded this trial, it was under a Democratic administration, and then under the trial, it went to a Republican administration, and I think the stockholders realized that in 2025, we were issued two stop work orders, and we were able to overcome them and continue the trial. From our standpoint, we are pleased to be, frankly, the only company that survived those stop work orders. A lot of other vaccine companies received them and have not continued to complete a trial. From our standpoint, we really enjoy our close working relationship with BARDA. We appreciate their partnership, and we continue to work together with them to finish out this trial.

David Carey
Senior Partner at FINN Partners

Thanks, Steven. James, next question for you. You said the data readout for the full phase II-B COVID-19 trial is expected in the first half of 2027. Now you are saying mid-2027. Can you please discuss why you have updated timing?

James F. Cummings
James F. Cummings
CMO at Vaxart

Thanks, David, and thanks for the question. As I went over just a little while ago, when you are executing a registration quality clinical trial that is this large, evaluating about 5,000 active participants across the nation, the timeline is fundamentally driven by deliberate protocol requirements rather than arbitrary spacing. Just to reiterate, the three primary drivers here that govern the calendar are the protocol-defined observation windows, and that is a comparative efficacy trial, cannot compress essentially biological time. Participants have to be monitored over set multi-month observation windows to evaluate real-world variant infection endpoints and measure both mucosal and systemic immune response durability. I mentioned some details about the laboratory processing and assay validation. Once these visits and sample collections wrap up, there are thousands of mucosal swabs and blood samples that undergo centralized laboratory processing, strict assay validation, and formal regulatory data locking before any unblinding can occur.

James F. Cummings
James F. Cummings
CMO at Vaxart

It is important to note that this sample processing is being performed at BARDA's partner labs, and these labs dictate the timing and the prioritization of our samples in the context of work that they do to support other trials and programs for BARDA. Federal governance and review alignment is another piece of this. Executing this study under Project NextGen means working in close coordination with the partners at BARDA. We have to adhere to federal oversight and the review processes that is part and parcel of that partnership, ensuring the dataset meets BARDA program goals, as well as every agency standard for regulatory review. Thank you.

David Carey
Senior Partner at FINN Partners

Thanks, James. Sean, next question for you. While top-line safety and side effect profiles from the sentinel group was impressive, investors are interested in underlying data such as immunogenicity, viral load, shedding, and severity of infection. Has Vaxart, BARDA, Sanofi, or any other entity seen this more detailed sentinel data yet? What about detailed full phase II-B data? Second part of this is, with the long wait for the full phase II-B data expected now in mid-2027, can shareholders at least expect to see more detailed sentinel data before end of year? If not, is it being withheld by BARDA, or is it Vaxart's decision to withhold it?

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

Thanks, David, for the question. Just to address your question directly, neither Vaxart nor any external entity is withholding data. Following the contract modification number seven, the study samples were submitted to two independent analytical laboratories for processing. Because these assays are handled externally, we cannot predict the exact timeline for when the labs will complete their analysis and provide the data. We have not seen it, or anybody else, the underlying immunogenicity data. Furthermore, under our contractual framework, any public dissemination or timing of these results is strictly contingent upon BARDA's formal review and approval. While we understand the desire for detailed sentinel readouts before year-end, we are certainly as anxious as you are. We cannot commit to a specific release date until the lab data is finalized, delivered, and cleared for disclosure through our established partner protocols.

David Carey
Senior Partner at FINN Partners

Okay. Thanks, Sean. James, this is kind of a similar question, but I will ask it to you as well. You previously said that you will share additional data cuts, so when are you going to do that?

James F. Cummings
James F. Cummings
CMO at Vaxart

Well, thanks, David. We are actively advancing these detailed analytics, though we are not in a position to provide a specific reporting timeline, as Sean mentioned, for additional interim data cuts right now. Our contract with BARDA provides the agency with authority over all trial readouts, so any disclosure timeline is dependent on that ongoing collaboration and approval process. We continue to maintain a strong, positive working relationship with the folks at BARDA, and we value their ongoing partnership as we advance this program together. Regarding overall trial milestones, we look forward to sharing efficacy and safety data from the main study cohort by mid-year 2027. Back to you, David.

David Carey
Senior Partner at FINN Partners

Thanks, James. Sean, another question for you. Can you provide more detail on the XBB immunology data, and what it tells us about the mucosal and systemic immune response?

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

Yeah. Thanks, David, for the question. As we've mentioned before, we don't have XBB clinical immune data yet, so we can't talk about it. I can just tell you that in animals, we know the vaccine was immunogenic.

David Carey
Senior Partner at FINN Partners

Thanks, Sean. Steven, back to you. Many shareholders continue to believe that a norovirus vaccine would be among the most valuable advancements for the company and the stock. Can you provide an update on where you stand with respect to partnering?

Steven Lo
Steven Lo
CEO at Vaxart

Sure thing. It looks like a few other questions just trickled in that are very related to this, so thanks, everybody, for asking the question on where we stand with the norovirus partnerships. I'll make three points here. First, we are navigating a broader biopharma market headwinds where many of the partners that we have been speaking to, they're tightening their capital allocation. They've had to deal with things such as most favored nation, et cetera. They are lengthening the diligence timelines a bit, and they're also getting increasingly selective. With that said, there does and continues to be interest in our norovirus phase II-ready candidate, and we are having conversations with potential partners. In addition to that, global public health entities, government stakeholders, et cetera. We are trying to secure a structure that advances norovirus without, of course, compromising any long-term value for the company.

Steven Lo
Steven Lo
CEO at Vaxart

Thirdly, if we end up with no one interested at all remaining at the table, we will, of course, communicate that clearly to the shareholders rather than prolong your expectations. We do have non-disclosure agreements in place, as well as the SEC requirements that preclude us from sharing interim negotiations or even naming the companies that we are speaking to. Please be assured that advancing and finding a way to fund norovirus remains one of the top priorities for the leadership team, and we will certainly share significant updates when we have definitive agreements reached. Again, thank you, everybody, for the interest there.

David Carey
Senior Partner at FINN Partners

Okay, thanks, Steven. Sean, another question for you. Can you provide more color on the implications of the norovirus European patent on Vaxart's business? Are there plans in place for commercialization in Europe, and how might this advance your partnering efforts?

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

Yeah, David, thanks for the question. The European Patent Office issued a patent in August of 2026 covering Vaxart's room temperature stable, needle-free tablet vaccine technology against norovirus. We see immense value in ensuring our intellectual property is protected, and it also ensured this oral vaccine could be available globally. Europe, of course, represents the second-largest market outside the United States., making it critical strategic territory for our portfolio as we look at broader worldwide commercialization. This patent expands our global intellectual property portfolio and extends protection through at least 2036 across 13 European nations. These include key markets like Germany, France, Italy, Spain, and the U.K. It also directly complements Vaxart's existing U.S. patent estate, creating multi-jurisdictional patent protection.

David Carey
Senior Partner at FINN Partners

Thanks, Sean. Another one for you. Management previously stated GII.17 strain dominance was an obstacle for partners. The latest CDC CaliciNet data seemed to show exactly the reversal those partners were waiting for. In the latest reporting period through September 2026, GII.4 Sydney has rebounded to approximately 46%, while GII.17 has declined to 17.5%. Given that GII.4 is once again the leading reported norovirus genotype, has this development led to any meaningful progress in those discussions? Also, can shareholders expect any GII.4 or GII.17 cross-reactivity data in the near term?

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

Yeah, thanks for the question. Strain prevalence continues to inform our discussions with potential partners for the norovirus program. The shift toward increased GII.4 prevalence might potentially improve the program's value proposition for the simple reason that we have GII.4 clinical data, but have not evaluated the GII.17 strain yet in the clinic. Having said that, Vaxart does have the ability to add strains quickly if necessary. We have not seen interference in animal studies or human trials, and our platform is relatively easy to adapt for each new antigen. One of the other things, of course, is that a key strength of our norovirus vaccine is that we have seen cross-reactive immune responses to many GII strains in adults. Some of these data were presented in 2025 at the International Calicivirus Conference.

David Carey
Senior Partner at FINN Partners

Thanks, Sean. Steven, question for you. What progress has management made toward securing a meaningful pharmaceutical partnership, license agreement, or strategic transaction?

Steven Lo
Steven Lo
CEO at Vaxart

Yeah, in terms of meaningful pharmaceutical partnerships and license agreements, I will say that in the last two years, we have actually made some meaningful progress. As an example, we entered into an exclusive worldwide license agreement with Dynavax for our COVID vaccine program. We secured $25 million upfront, as well as a $5 million direct equity investment at a premium to the market price. In the future, should Sanofi opt in, since they bought Dynavax, we are eligible for up to $670 million in future clinical, regulatory, sales milestones, and tiered royalties.

Steven Lo
Steven Lo
CEO at Vaxart

That is certainly for us, a very meaningful partnership, because on top of that, this is a study that we entered into a partnership with BARDA under Project NextGen, where they delivered hundreds of millions of dollars in non-dilutive clinical funding to get us to the point where we are almost at the clinical trial results in mid-2027. Certainly, those are examples of meaningful partnerships and agreements that the company has entered into in the last two years. Beyond COVID, as we were talking about earlier, the leadership team is actively engaging in speaking to pharmaceutical global health stakeholders to consider partnerships for norovirus.

Steven Lo
Steven Lo
CEO at Vaxart

As an example of how much we believe in the value of norovirus, as Sean was talking about, we made the investment to prosecute the patents in Europe, because if there is a global partner who is interested, seeing that we have patent protection to 2036 is also very meaningful. We are making investments in our pipeline, and specifically actively looking for a reasonable partner on the norovirus program.

David Carey
Senior Partner at FINN Partners

Okay. Thanks, Steven. Steven, another question for you. Has Vaxart submitted or are you considering submitting a proposal for BARDA's NPIVS program?

Steven Lo
Steven Lo
CEO at Vaxart

Yeah, I'll first say, as we were saying earlier, we enjoy a very good working relationship with BARDA, so that always keeps the dialogue going. What the management team does is we always monitor, and we're pretty aggressive in pursuing non-dilutive grants, other agency partnerships, and this is across respiratory and pandemic preparedness indications. Obviously, this is a good way to support our clinical pipeline, as you've seen with the COVID study. At the same time, we want to be very cognizant of being capital efficient, so we do spend a lot of time looking at all of these opportunities. Any of these contract awards or new federal partnerships that are announced publicly, we stick to our disclosure requirements. We do not publicly state what or when we apply for these, because we don't want to jeopardize our chances of getting the award, because oftentimes, that could impact it.

Steven Lo
Steven Lo
CEO at Vaxart

On top of that, because we are in a competitive environment, we don't want to share information so that a competitor is aware now of a very similar grant, and then now they're also applying for it as well. These are the reasons why we may not get into specific details, but I do want to say that we monitor for all of them. We're very diligent, and we're certainly aware of all the opportunities there. So thanks for reminding us of that.

David Carey
Senior Partner at FINN Partners

Okay. Thanks, Steven. A question that we just received on the portal, and Jeroen, I'll direct this to you. When do we expect the milestone payments from Altesa Biosciences?

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

Thank you, David. Just for context for people on this call, the Altesa Biosciences reference is to an out-license agreement we did for one of our assets historically as a company called Vapendavir. It is a clinical stage, broad-spectrum antiviral that Altesa Biosciences is developing and is currently in a phase II-B study. The agreement calls, and as we disclosed in 2021, for about $130 million, up to $130 million in development and commercial milestones, as well as tiered royalties. This program is not under our control, clearly. Altesa Biosciences is developing this. It is in phase II-B. None of the milestones are due at this time.

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

As the question is around timing, since we do not control the study ourselves, it is impossible for me to speculate on the timing of advancement, and we have not previously disclosed what exactly triggers those milestones, and I am not going to do so now. But clearly, it is a great question to at least make everybody aware that that is something that is actively in development, and there is potential future dollars due to our company.

David Carey
Senior Partner at FINN Partners

Thanks, Jeroen. Steven, back to you. Has the Sanofi relationship expanded beyond COVID to discussions around Vaxart's broader platforms, such as influenza, norovirus, or any other assets?

Steven Lo
Steven Lo
CEO at Vaxart

Our current Sanofi agreement, and as a reminder, this is something that Sanofi acquired in their acquisition of Dynavax, whom we did the original COVID-19 collaboration and licensing deal. That is only for the COVID-19 vaccine program. We actually are interacting with Sanofi quite a bit, as well as through regular joint steering committee meetings. But they are solely focused on the phase II-B study, delivering a robust clinical data package so that we can ensure a high chance of opt-in. As a reminder to our stockholders, if Sanofi opts in, that results in a $50 million payment to the company. I think you can imagine why we are spending a lot of time making sure that we build that relationship, but also executing on the study, as James had highlighted very well.

Steven Lo
Steven Lo
CEO at Vaxart

Now, with a very close working relationship with Sanofi, I think it is safe to say that they are becoming more increasingly aware of our platform, the science behind it, which Sean has gone over. From that standpoint, I can say that they are certainly aware of other programs we have in the pipeline.

David Carey
Senior Partner at FINN Partners

Thanks, Steven. Another one for you, actually. To the extent allowed, can you give shareholders more visibility into current partnership and non-dilutive funding discussions?

Steven Lo
Steven Lo
CEO at Vaxart

Sure. I think I answered a very similar question, but I will certainly talk a little bit more about this. We are always looking for-

David Carey
Senior Partner at FINN Partners

Yeah, you did.

Steven Lo
Steven Lo
CEO at Vaxart

-opportunistic ways to leverage our platform to create more value. Our current priorities are we want to execute on the phase II-B COVID study, right? As I was sharing earlier, it would be nice to have a $50 million opt-in payment, and so we want to do this correctly, execute the right way in conjunction with our current partner, BARDA, and hopefully we will have a great partner in Sanofi. With that said, we continue to look for other non-dilutive funding opportunities, as the team was talking about earlier, whether it is government agencies, and these are agencies even outside the United States. We speak to global pharma companies. We speak to regional pharma companies as well. So, we look at territories that are outside the United States.

Steven Lo
Steven Lo
CEO at Vaxart

We look at the United States, of course, and then we also look at the European territory, as evidenced by, once again, the work that Sean and our IP team have done to secure patents for norovirus in Europe. So, those are the types of discussions that we have. For obvious reasons, when we enter into deeper discussions, we have to go under an NDA, a non-disclosure, and therefore, it prevents us from naming companies and, of course, providing any details into them. Please be assured that if we obviously end up in a very good situation where a deal is signed, we will disclose that immediately, very similar to what we did when we disclosed our deal with Dynavax last year.

David Carey
Senior Partner at FINN Partners

Thanks, Steven. Sean, Becker's Hospital Review. Have you considered pursuing other indications for your oral vaccine platform outside of COVID, norovirus, et cetera?

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

Thanks for the question. The short answer is yes. I think everybody is aware that we have an HPV vaccine, therapeutic vaccine in development, that is in pre, and we published on it from preclinical standpoint. The other thing is that you may not be aware that years ago, we received NIH funding to evaluate our platform against Venezuelan equine encephalitis virus. This is one of the things we were able to do from using non-dilutive funding to advance not just this indication, but our platform as well. Keep in mind, of course, we are always optimistic about ways to leverage our platform to create additional value or obtain non-dilutive funding to initiate advanced current or additional programs. That said, initiating or expanding any new indications remains strictly contingent upon securing appropriate funding or strategic support.

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

As we previously stated, our current priorities are executing the phase II-B COVID-19 trial and securing a partner on funding for the norovirus program.

David Carey
Senior Partner at FINN Partners

Thanks, Sean. Steven, what is the current plan for Vaxart beyond the COVID-19 readout in mid-2027?

Steven Lo
Steven Lo
CEO at Vaxart

Yes. The first piece, as I mentioned earlier, is with the COVID-19 readout, we want to work very hard on submitting the phase II package to the FDA, and of course, at that point, Sanofi will see the results as well. We definitely want to ensure that we have an opt-in and a $50 million payment. That, of course, means leveraging the support of our partner, BARDA, and making sure that we get to a very good point where Sanofi has good belief that this will have a great opportunity in their pipeline. Beyond that, and this is, I think, a good example of, we believe that the other assets in our pipeline are important. Oftentimes, a readout of one asset enables others to be of higher confidence.

Steven Lo
Steven Lo
CEO at Vaxart

Interesting enough, and we're seeing questions for, "What are you thinking about doing with flu?" as an example, right? Having a positive readout in a respiratory virus like COVID-19 actually gives greater confidence for other partners or other funding sources to say, "We also believe in flu." That is, in a sense, a strategy that is tied to a certain portfolio. As we talked about earlier, we're working very hard to move forward what we can with getting norovirus funded. Again, it's usually non-dilutive, and partnerships is where we start. The other thing I'll add is, as we continue to be successful, we're gaining more experience with the platform. Sean has, of course, and his research team created some great opportunities with the second-generation construct and other areas.

Steven Lo
Steven Lo
CEO at Vaxart

But at the end of the phase II-B trial, think about this, we will have dosed more than 6,500 subjects with our oral vaccine platform. From my standpoint, that also provides greater confidence to any other parties out there who are interested in partnering with us.

David Carey
Senior Partner at FINN Partners

Thanks, Steven. Sean, I am going to direct the next question to you. What measurable accomplishments can management point to that have created tangible shareholder value over the past few years?

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

Yeah. Again, thanks for the question. As the longest-term shareholder of Vaxart, I can assure you we work really hard at creating shareholder value with the funding we have. While leadership recognizes that tangible shareholder value is ultimately reflected in market valuation, our primary mandate over the past several years is focusing on de-risking and advancing our mucosal vaccine platform. As an example, we work really hard at writing non-dilutive proposals, and we are really proud to be able to secure the landmark non-dilutive funding through Project NextGen. BARDA is fully funding our large-scale COVID-19 comparative trial and allowing us to dose significantly more subjects to generate robust, meaningful data.

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

We then parlayed this into a licensing deal with Dynavax, and again, this has happened in the last few years, which is bringing additional non-dilutive funding of $25 million, along with a $5 million equity investment at a premium to the market price of our stock. Had that COVID-19 study not been funded, the company at that point would not have any funding to advance any clinical studies, and we would have been in a very dire financial position. To ensure survival, leadership has taken decisive operational measures to preserve liquidity, including reducing the organization size, implementing across-the-board budget cuts, and optimizing our real estate footprint to dramatically reduce cash burn while still advancing our bivalent norovirus program.

Sean Tucker
Sean Tucker
Founder and Chief Scientific Officer at Vaxart

These actions have validated our oral platform through elite federal partnerships, expanded our clinical data generation without over-diluting stockholders, and established the lean operational and financial foundation required to build a sustainable long-term enterprise value as our trial endpoints mature.

David Carey
Senior Partner at FINN Partners

Thanks, Sean. Steven, next question is for you. Can you explain the evaluation process for identifying the seventh independent director? What were the criteria?

Steven Lo
Steven Lo
CEO at Vaxart

Yes. First of all, we are pleased to have Dr. Bono join our board of directors. She was appointed per the cooperation agreement that Vaxart entered into with the stockholder group. This is back in July of this year. It was a collaborative process with the stockholder group, so I want to really thank them for their engagement, for their ideas. They, along with Vaxart, had submitted nominees, so we all looked at the nominees together, and together we looked for an individual with extensive operational experience, leadership, public health experience. As you can tell, Dr. Bono meets the criteria there, and especially with her distinguished background as a three-star vice admiral in the U.S. Navy, former director of the Defense Health Agency, trauma surgeon, former director of the Health Systems Response and Global Health Operations for the state of Washington during COVID, and also Viking Cruises.

Steven Lo
Steven Lo
CEO at Vaxart

She was jointly selected by both the stockholder group and by Vaxart.

David Carey
Senior Partner at FINN Partners

Steven, a follow-up question to that. Who else did the group consider, and what made Dr. Bono the best candidate?

Steven Lo
Steven Lo
CEO at Vaxart

Yeah, so we did consider many candidates. We are not able to share the names of the candidates, but we looked at many well-qualified candidates. This was a joint decision. Once again, I want to acknowledge the stockholder group for working very closely with us. We had many meetings, so they were truly looking out for the best interests of the stockholders when we were working very closely with them. As I stated, Dr. Bono's experience, I think her qualifications speak for herself, that she is absolutely the best candidate to be joining the board, and I know she is looking forward to engaging and working with the Stockholder Engagement Committee.

David Carey
Senior Partner at FINN Partners

Okay. Steven, another question. Given the recent reorganization of board leadership and establishment of new oversight committees, have any specific charter mandates been assigned to evaluate capital market strategy, executive compensation alignment, and strategic transaction alternatives?

Steven Lo
Steven Lo
CEO at Vaxart

In terms of capital market strategy, executive comp alignment, and strategic transactions, yes, all of those are actually part of the purview of the board, as a full board, and there are going to be specific initiatives that are assigned to committees. As an example, executive compensation alignment is assigned to the compensation committee of the board. We recently made a change in the chair of that committee, and now it is Dr. Jim Breitmeyer as Chair of the Compensation Committee.

David Carey
Senior Partner at FINN Partners

Okay. Another question for you, Steven. Is the compensation committee adjusting executive bonus structures, stock options, and equity grants to tie leadership payouts strictly to clinical milestones and market cap performance?

Steven Lo
Steven Lo
CEO at Vaxart

Yes. The compensation committee looks at all the factors in terms of the company's goals, the corporate goals, the performance metrics of all the individuals on the management team, but also the company as a whole, and they align the compensation to the metrics that are ultimately approved by our board of directors.

David Carey
Senior Partner at FINN Partners

Thank you. Another question for you. As part of the stockholder agreement, both parties agreed to form a shareholder advisory council. Will this be limited to only the stockholder group members, or will it be opened up for other shareholders to request being considered to serve as well? Steven, any response to that?

Steven Lo
Steven Lo
CEO at Vaxart

Sure. The specific language in the cooperation agreement calls us a Stockholder Engagement Committee, which is chaired by Dr. Bono. I'll certainly say that we're deeply committed to input from not just the stockholder group that had signed the cooperation agreement with us. As evidenced by us taking questions here and having a fireside chat, we really do want to have a constructive and open dialogue with our entire investor base. But in the cooperation agreement, it does specify that we'll have meetings and conversations with that group. It is our hope, and we would certainly encourage this, that we broaden the discussion to beyond the stockholder group. I'm fully confident that Dr. Bono has been thinking through, and we're working very closely with her on how best to engage folks.

Steven Lo
Steven Lo
CEO at Vaxart

As evidence of her listening in and participating here in this fireside chat, you can tell that she, along with Mark Watson, another member of our Stockholder Engagement Committee, were dedicated to ensure that we receive the input from as many shareholders as we can, and we will continue to involve as many as we can, as we are doing here.

David Carey
Senior Partner at FINN Partners

Thanks, Steven. Another question for you. How does the committee plan to prioritize feedback it receives from shareholders and ensure it translates into meaningful discussions at the board level?

Steven Lo
Steven Lo
CEO at Vaxart

Yes. We are utilizing all avenues. As an example here, many of the questions are being submitted. We group them, and we understand what themes are coming across. We review the emails that come in, and as well, we will have the Stockholder Engagement Committee meetings. We are really incorporating all the feedback, and this will help us jointly with the stockholder group prioritize what are the important, meaningful discussions we need to have. They are going to, meaning the stockholder group, will provide the input, and of course, by providing that input to the committee, it makes it to the board level.

David Carey
Senior Partner at FINN Partners

Thanks, Steven. Jeroen, a question for you. With cash runway into the second quarter of 2027 and the phase II-B readout expected in mid-2027, what is management's plan to bridge through the readout and potential Sanofi decision while minimizing dilution?

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

Thank you. That is a great question, and it is something top of mind for our shareholders, I am sure. Our plan to bridge through that phase II-B COVID-19 readout rests really on three main pillars. Clearly, disciplined cost management at first. Secondly, I guess, a continued drive for non-dilutive funding. Then finally, I guess, preserving optionality on the timing and the financial terms associated with any future capital raises. On the first point, around cost management, we continue to prioritize spend against our major value drivers, clearly the BARDA-funded phase II-B study, but also the whole norovirus program. We have taken steps to keep corporate spending very tightly controlled through this readout window, just to make sure that, again, we are just as efficient as possible on everything that is not directly associated with these programs.

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

On the topic of non-dilutive capital, the BARDA contract funds the execution and data analysis of the phase II-B study directly, and James has taken us through the details of that. Alongside that, we are pursuing co-development partnerships, licensing, public health grant funding, and Steven has gone extensively through the status of those efforts. Finally, on financing flexibility, we have access to a $25 million equity line of credit with Lincoln Park Capital. This is one of the tools that we have available. It is not a financing plan in and of itself. Our intent is to continue to use that equity line very selectively and only to the extent it is needed to maintain flexibility into these COVID study readouts.

David Carey
Senior Partner at FINN Partners

Thanks, Jeroen. Steven, another question for you. Why have the board and executive leadership purchased shares in Vaxart?

Steven Lo
Steven Lo
CEO at Vaxart

Actually, the board and executive leadership have purchased shares in Vaxart. On top of that, we have recently adopted a board stock ownership policy that has certain requirements for our board members to own shares. Look at the documents that were filed, and hopefully that will explain that they do need to purchase shares at a minimum. On top of that, many members of our management team, including myself, have actively committed our personal funds to purchase shares either directly or through the employee stock purchase plan. We are teaming up with all of our shareholders and rooting for the fact that we want our share price to improve.

David Carey
Senior Partner at FINN Partners

Okay. Thanks, Steven. Next question, Jeroen. This is related to Lincoln Park Capital. The recently released Form 10-Q shows a dilutive cash raise in the amount of $420,000 via share sales to Lincoln Park Capital in Q3. Can leadership explain the purpose of diluting for this relatively small cash raise at a time when cash runway is still well-funded?

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

Yeah. Thank you, David. We are looking at is really that cash runway is constrained relative to the anticipated timing of this phase II-B readout and the potential opt-in by our partner on this COVID-19 program. While we believe that the terms of this equity line, those are fair, competitive terms, we understand that dilution is top of concern for our shareholders, so we understand that it's a challenging point for shareholders. What we've chosen to do here is really use this equity line very judiciously, and that's what this reflects. We've only raised $420,000 in the third quarter through this, which is properly characterized as a dilutive capital sourcing mechanism. But we've used it very, very judiciously in a small amount as we deemed necessary, and we're trying to avoid higher impact to the share count.

David Carey
Senior Partner at FINN Partners

Thanks, Jeroen. A follow-up question related to that. If you were to sell shares under the Lincoln Park agreement, how far could that extend your cash runway?

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

Yeah, as I've noticed before, the full line of credit is for $25 million. If we were to exercise that entire line of credit, that would potentially extend our cash runway into 2028. But as I just said, we continue to pursue alternate non-dilutive sources of capital as a first priority and use this credit line only judiciously, as we look at all the funding options in front of us.

David Carey
Senior Partner at FINN Partners

Thanks, Jeroen. Next question, I guess would be either for Jeroen or Steven. Why is Vaxart recruiting a VP of technical operations while significantly reducing R&D expenditure?

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

Yeah, thanks, and I'll take this one as well. So, again, we understand and appreciate that executive hiring in the midst of this challenging cash situation draws scrutiny. We're definitely in a situation where we need to manage capital very carefully, and we understand our shareholders' concerns. But attracting experienced leadership is essential for us to advance our pipeline, and we make each appointment very carefully with the company's resources and constraints therein, and our strategic priorities firmly in our minds. I'd like to remind you of the terms of the agreement with Dynavax, as we disclosed in the November 2025 Form 10-Q. When we talked in that agreement about things like, under a technology transfer in that agreement with Dynavax, it calls for us to disclose and transfer Vaxart know-how. It mentions transfer of master batch records for manufacture of phase II-B materials. It mentions analytical method transfer.

Jeroen Grasman
Jeroen Grasman
CFO at Vaxart

It mentions that all this needs to be done on a timeline that Dynavax, in good faith, determines is necessary for initiation of manufacture of phase III clinical trial material. All those things point to us needing to be ready for that particular step. So, despite constrained capital, we need to make sure we have the capabilities in our technical operations team to enable a successful future potential opt-in, even at a time when capital here is constrained.

David Carey
Senior Partner at FINN Partners

Thanks, Jeroen. We're getting close to time, but a follow-up question related to that. Steven, if you could take this one. Could you please discuss management's plan with regard to manufacturing, considering recent hires such as the new CTO?

Steven Lo
Steven Lo
CEO at Vaxart

Right. This is in regards to our, on top of what Jeroen just answered, this is also a related question on hiring our Chief Technology Officer, Todd Lopeman. I will first say that we conduct our clinical manufacturing here in South San Francisco. It is considered a competitive advantage. In fact, one of the reasons why we were able to continue our study with BARDA was that we were able to clinically manufacture another strain. We went from XBB to KP.2 within about a quarter, and BARDA was really pleased with that. So, having the internal manufacturing here is a competitive advantage. On top of that, having manufacturing in the United States, is also a very important piece, especially if we are being funded by the U.S. government.

Steven Lo
Steven Lo
CEO at Vaxart

As we look towards the future, as Jeroen just highlighted, part of what our obligations are, is moving forward with tech transfer and having experience and capabilities with a person like Todd, who not only has in his career at large pharma, but also at Dynavax, been involved in clinical manufacturing. He has actually overseen the tech transfer. He has actually overseen phase III manufacturing. He has overseen commercial manufacturing. From our standpoint, having someone with that experience also puts us in a competitive position for the future. Again, many times we are really highlighted on our know-how and capability within the manufacturing group.

David Carey
Senior Partner at FINN Partners

Thanks, Steven. We are about at time, but I am going to pass it back over to you for any closing remarks.

Steven Lo
Steven Lo
CEO at Vaxart

Great. Let me thank all of you for joining us today and for your questions. We were certainly able to fill the hour up, and really thank you for your engagement. The third quarter reflects continued progress across our clinical programs, pipeline, and governance, including securing our norovirus patent protection in Europe through 2036, publishing peer-reviewed preclinical data showing 100% protection against the lethal H5N1 avian flu, methodically progressing our phase II-B COVID-19 trial as we advance toward our mid-year 2027 milestone, and welcoming Dr. Rocky Bono to our board to lead our Stockholder Engagement Committee. Everything we do is guided by a singular mission, breaking down the barriers of traditional needle-based vaccines by delivering stable, easy-to-distribute oral pill vaccines that provide mucosal and systemic protection directly where pathogens enter.

Steven Lo
Steven Lo
CEO at Vaxart

We want to sincerely thank our trial participants, investigators, and our dedicated team here at Vaxart, whose hard work makes this research possible. Thank you to our stockholders for your engagement and continued support. We look forward to updating you on our progress in the months ahead, and we wish you all a great evening.

Executives
    • Mark Watson
      Mark Watson
      Lead Independent Director and Member of the Stockholder Engagement Committee
    • Rocky Bono
      Rocky Bono
      Independent Director and Chair of the Stockholder Engagement Committee
    • James F. Cummings
      James F. Cummings
      CMO
    • Jeroen Grasman
      Jeroen Grasman
      CFO
    • Sean Tucker
      Sean Tucker
      Founder and Chief Scientific Officer
Analysts
    • David Carey
      Senior Partner at FINN Partners