Vaxart Inc (VXRT) 2024 Q3 法說會逐字稿

Greetings and welcome to the Vaxart Business Update and third quarter 2024 financial results conference call, a question and answer session will follow management's opening remarks. Individual investors may submit written questions to Ir at Vaxart dotcom.

As a reminder, this conference is being recorded.

I would now like to turn the webcast over to your host ed by senior Vice President and General counsel.

Good afternoon and welcome to today's call. Joining us from Vaxart are Stephen Lowe, Chief Executive Officer Dr Sean Tucker, founder and Chief Scientific Officer, Dr James Cummings, Chief Medical Officer and Phil Lee, Chief Financial Officer.

Before we begin, I would like to remind everyone that during this conference call, Basar may make forward-looking statements including statements about the company's financial results, financial guidance, its future business strategies and operations and its product development and regulatory progress, including statements about its ongoing or planned clinical trials.

Actual results could materially differ from those discussed in these forward-looking statements due to a number of important factors including uncertainty inherent in the clinical development and regulatory process and other risks described in the risk factor section of Vaxart's most recently filed annual report on form 10-K and also on other periodic reports filed with the Sec Vaxart undertakes no obligation to update any forward-looking statements after the date of this call.

I'll now turn the call over to Steven Lowe. Steve.

Thanks Ed and thanks to all of you for joining us this afternoon on today's call. I'm excited to highlight a number of accomplishments that we have achieved since our last update. I'll then have James and Sean share updates on our COVID Norovirus and HPV programs perspectively, then Phil will discuss our financial results before we open the call for your questions.

When I joined Vaxart earlier this year, we set out clear objectives with the goal of advancing our oral pill vaccine platform and bringing a potentially transformative solution to improve public health. Not only does our platform show promise in addressing many of the shortcomings of injectable vaccines such as using mucosal immunity to potentially block infection and transmission. But it also improves delivery convenience and has demonstrated a benign safety and tolerability profile across 19 clinical trials. To date. In summary, we continue to see the potential for a truly differentiated and transformational platform.

Today, I am pleased to report that we have achieved several milestones in executing on our goals starting with our COVID program. Through our partnership with Barda. We have taken a major step forward in finding a new way of confronting pandemics in the future.

In September, we started enrollment in our phase two B study evaluating our COVID 19 oral pill vaccine candidate against an approved Mrna vaccine comparator interest for our trial is strong and it is our goal to progress this study as rapidly as possible. Jens will discuss this trial in more detail shortly. But I would like to note that as recipients of one of the largest Barda funded project nextgen awards to date now valued at up to $456 million. We appreciate this collaboration and look forward to continuing our work with our government partners as we track vaccination trends. This season, we have seen COVID vaccinations increase substantially post KP two availability beginning in late August and early September. In fact, data that's tracked by Alvia suggests that approximately 35 million people will receive a COVID vaccine dose in the US alone. This is comparable to last year's season of approximately 40 million doses. It is clear that there remains robust demand for a COVID vaccine and we believe that our solution can address this demand more efficiently and effectively than current injectable methods.

Turning to our Norovirus program, we have had fruitful communication with FDA and recently received constructive feedback on our data for potential correlates of protection. Sean will share a deeper dive of our assessment and planning. But I will note that we are taking a thoughtful approach in the best way to progress. This program, we are meeting with a number of advisers and disease experts as we evaluate the best clinical development path.

In addition to our conversations with FDA, we were pleased to have presented promising data of our trials at Infectious Disease Week and the World Vaccine Congress underscoring our commitment to this significant unmet need given that there are currently no approved vaccines against norovirus. This is a highly contagious virus and is the leading cause of acute gastroenteritis symptoms such as vomiting and diarrhea and sickens approximately 21 million people in the United States each year. It is one of our three pipeline programs with a multibillion dollar market and we are determined to advance this program forward.

In addition to our two lead clinical programs in COVID and Norovirus, we are continuing to look for the opportunity to advance our other programs with careful investment to further advance other indications. As an example, we recently published promising preclinical data on our HPV vaccine constructs in the August publication of vaccines which suggests that our mucosa vaccine platform represents a possible noninvasive approach to prevent the progression to cervical cancer. We have additional preclinical studies planned to further characterize the immune stimulating and anti tumor activity of our HPV vaccine.

We look forward to sharing updates from our Barda funded phase two B COVID trial, detailing the next steps in our norovirus program and determining the best strategic opportunities for our other programs. I'll now turn the call over to James to provide a further review of the recent progress for our COVID 19 program.

Thanks, Steve the Bar A phase two B clinical trial will provide an important readout that could further validate our platform and highlight the possibility of a new alternative to current injected vaccines against COVID 19.

It's our belief that the cross reactivity of our vaccine candidates mucosal immune responses could have a significant impact against evolving variants with a better safety and tolerability profile versus the MRN A comparator.

Based on data generated from prior trials, our vaccine candidates have shown that participants had increased IG A antibodies to SARS COVID two, the virus that causes COVID 19 while maintaining immunization protection against current and future COVID 19 variants and a benign tolerability profile.

We thank Barda for their strong leadership partnership and funding to make this phase two B trial a reality.

As a reminder, the phase two B clinical trial is a double blinded multicenter randomized comparator controlled study to determine the relative efficacy safety and immunogenicity of Vaxart's oral pill COVID 19 vaccine candidate compared to an approved MRN A COVID 19 injectable vaccine in adults previously immunized against COVID 19 infection.

The sentinel cohort comprises of 400 participants with 200 receiving Vaxart's XPD vaccine and 200 receiving an approved MRNA XPD vaccine comparator.

We are making good progress in enrolling these participants and expect to complete dosing for this cohort later this month.

Once enrollment is complete, an independent data safety monitoring board or DS and B and the US FDA will review the 30 day safety data on the 1st 400 participants.

After a signal to proceed from the reviewers, we will then enroll the remaining 10,000 participants in the second phase of this study.

The phase two B study will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction and safety.

The primary endpoint is relative efficacy of Vaxart's COVID 19 vaccine candidate compared to an approved Mrna COVID 19 vaccine for the prevention of symptomatic disease.

Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit, 12 months, post vaccination.

We anticipate that it will take about six months to completely enroll this study.

I'll now hand the call over to Dr Sean Tucker, our founder and Chief Science Officer for a brief discussion of our Norovirus program and our recent HPV publication.

It's gone.

Thank you James. As Steve mentioned earlier, we received constructive feedback from the FDA on our data for potential correlate of protection and next steps for our Norovirus program. While we believe we have identified a functional antibody response that may be associated with protection from norovirus. The FDA requested new clinical data before proceeding with further review of our potential correlate.

We are reviewing the current guidance from the FDA and consulting with disease experts before announcing next steps with our program.

Additionally, we have created additional norovirus G one and G 24 constructs that we believe based on preclinical data may be more potent than the constructs being evaluated in clinical trials. We are discussing the regulatory feedback from the FDA. The clinical data on current constructs and the preclinical data generate our new constructs with our advisers and certain key opinion leaders to assist us in determining the best way to progress our Nora Vrus program.

We look forward to progressing the norovirus program using the best available information and technology as part of our commitment to developing the first approved oral norovirus vaccine.

Last month, I had the honor presenting data related to our Norovirus challenge study at IDWE. I want to take this time to share a few key takeaways from my presentation.

It featured encouraging results from our phase two double blinded placebo controlled study, evaluating our G 11 vaccine candidate against placebo given to healthy subjects infected 29 days plus after vaccination, our norovirus oral vaccination was shown to induce mucosal and systemic immune responses with our most significant effects against infection and shedding in the face of a vigorous human viral challenge model.

Through machine learning, we are able to identify potentially new correlates of protection, protection against infection most tightly associated with making a functional antibody response to norovirus and fecal IGA.

By comparing prediction performance of a range of individual markers and ranking them. We will ascertain whether combining individual immune markers improves protection prediction for protection against norovirus.

Additionally, I'm pleased to share the findings from our colleague, Dr Lam W's presentation at IDWE regarding our phase one study about our norovirus vaccine candidate in healthy lactating females and their nursing infants.

Our candidate safety profile lined with our previous trials with the side effect profile similar to placebo and was well tolerated in postpartum lactating subjects.

In terms of mutagenicity, antibodies to norovirus rose on an average fourfold for the G 11 virus strain and sixfold for the G 24 virus strain in the breast milk of lactating mothers who received a vaxart vaccine candidate in the high dose group.

Further, we found those antibi could be tested in the fecal samples of breastfeeding infants showing the potential of passive transfer through breast milk. We continue to explore the durability of the immune response, nasal and sole very iga responses and safety through 36, 365 days.

Given the challenges of developing a norovirus vaccine in infants, these results in breastfeeding infants represent an important and creative initial step in the development of the norovirus vaccine that is safe and immunogenic with the potential to decrease norovirus severity in infants.

Overall, we are highly motivated and committed to further progressing our norovirus oral pill vaccine program which has demonstrated robust immunity, promising efficacy and a benign safety and tolerability profile. To date, the totality of evidence will help inform our clinical development plan.

With regards to our HPV program. I am pleased to say that we recently published promising preclinical data on our HPV vaccine constructs in the august issue of vaccines. Our preclinical data showed that the eight Vaxart's HPV vaccine constructs stimulated specific T cell immune responses in an animal model of HPV related tumorogenesis. These data also suggested that administration of a mucosal vaccine against these proteins in mice with HPV expressing tumors led to reductions in tumor size and increased survival. These data support the promise of our mucosal vaccine platform as a possible noninvasive approach to prevent the progression to cervical cancer.

We have additional preclinical studies planned to further characterize the immune stimulating and anti tumor activity of our HPV vaccine. I'll now hand the call over to Phil Lee our co for a brief discussion of our financials. Phil.

Thank you Sean. The details of our financial results for the third quarter of 2024 are summarized in today's press release revenue for the third quarter of 2024 was $4.9 million compared to $2.1 million. In the third quarter of 2023 revenue in the third quarter of 2024 was primarily from government contracts related to Barda revenue. In the third quarter of 2023 was primarily from revenue recognized for work performed under Vaxart's grant from the Bill and Melinda Gates Foundation and noncash royalty revenue from the sales of Inve in Japan.

Var ended the third quarter of 2024 with cash, cash equivalents and investments of $58.7 million.

Based on our current plan, Maxar continues to anticipate cash runway into 2026.

Thanks everyone for your time today. We will now open the call for your questions.

Thank you.

We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue, the participants using speaker equipment. It may be necessary to pick up the handset before pressing the star key one moment, please. While you call for questions.

Our first question comes from the line of Chang Li with Oppenheimer. Please proceed with your question.

Oh, hi. This is from Hamer. Thanks for providing the update and taking the question, maybe a couple from us. First on the COVID 19 phase phase two study. I'm curious about we can talk about the interest level from investigators and how do you see the current enrollment progress versus your maybe internal projections?

And also I remember before you talk about the potential interim analysis in the face to be study. So curious if you are still planning to do an interim analysis based on a certain number of events accrued.

And my second question just on Norovirus program. I'm just wondering if you can provide some more color on the feedback you received from the FDA and maybe specifically what kind of new clinical data is required? Thank you so much.

Great, thanks and thanks for your questions. This is Steve. I'll address the first question and then I'll turn over to Sean for the other two. Your question related to just interest level from investigators and enrollment, as we were saying in the opening remarks, you know, we're pretty happy to be on track with getting to the 400 participants in the sentinel study. And we haven't had any problem with enrolling patients. I mean, there's there's interest and just from tracking in terms of just vaccines in the marketplace right now, there is still quite a good uptake of the COVID vaccine. So from our perspective, that's going well and we hope to announce an update shortly when we reach the 400 I'll turn over to Sean on the interim analysis.

In terms of your question on the interim analysis with our partners at Barda. We are considering an interim analysis that would evaluate safety and efficacy signals. However, our focus and commitment will be to complete the full study through the 12 month visit, post vaccination for all participants that complete the trial. Preliminary data from our previous clinical preclinical studies indicates our vaccine triggers a mucosal immune response that may be superior injectables. And that is something we are we will explore throughout the trial.

And then the last question was around just specific feedback from the FDA on the Norovirus Chung. I just want to make sure we captured your last question correctly.

Yes, I'm curious about like any specific feedback you can share with us on, on the FDA conversation and also kind of what kind of the specific clinical data where is required for next step? Thank you.

Sure. Well, obviously we had discussions with the FDA. Our goal is to get into a phase two B study and an end of phase two meeting, we did get some clarity and, and in terms of what the requirements will be, we aren't discussing the details at this time, but we feel like we got a clearer path forward to be successful and get to the end of phase two meeting.

Okay. Thank you so Much.

Thank you.

Our next question comes from the line of Mayan Montani with BY security. Please proceed with your question.

Good afternoon. Thanks for taking our questions and congrats on the progress. So it seems like the COVID Sentinel cohort enrollment has gone very quickly. We, we'd love to hear on your thoughts on the DS MB 30 day safety analysis. You know, what are you kind of looking for there or, or DS MD and FDA is looking for there? And, and also how are you managing the study blind here? And, and in terms of the mucosal immunity related endpoints, you're assessing any, anything you could comment on the expectation for potential separation relative to the MRN A vaccine seems like there are a lot of serum, nasal and T cell end points listed on your clinical trial drug page if you know, if you could provide any color and then I have a quick follow up on virus.

Sure. In terms of the first question, when you're asking about the DSMB feedback and our expectations, well, we're still blinded. So the DSMB will, you know, put together a summary and our expectation is that there will be no safety concerns and we'll continue to enroll at the end of it. I mean, that would be our expectations.

And what was? And your second question again, my interest. Oh, it was about the samples. Yeah, we're taking saliva, nasal swabs and obviously some pbmcs from the standpoint of the 10,000 subjects. And we'll get some analysis in terms of how each vaccine will do or in terms of making those mucosal as well as, you know, systemic responses. Again, we're still blinded. So we won't see that data for a while. But the goal is to definitely compare the two vaccines for systemic and mucosal immune induction.

understood and, and maybe just to clarify the interim analysis, you, you intend to have that definitely at a 12 month time point, maybe could be at a lesser sample size than 10,000. Is that what I heard? You could consider?

Yeah. So what was in the protocol as right as of now is that we were planning to do an interim analysis once there was 225 cases, if I'm not mistaken, 255 sorry, I was just corrected.

And at that point, there would be an interim interim analysis to look at the differences between the two vaccine. And again, it's relative efficacy. So it essentially would ask the question, how many people in each group had been infected with SARS COV two. And that's part of again, as part of the protocol to date. Again, we are under discussions with our partners, you know, and what their intentions are. And, but the key thing from our standpoint is, you know, we want to look at 12 months of data at the end of this because that will be very informative, I believe particularly as new variants pop up over that 12 month period.

Oh, very helpful. Thank you. And then on the Nexgen Novis G 11 and G 24 constructs, anything Sean, you could comment on the, the, the design and if, if you intend to publish pre preclinical data that you, you probably have, have been accumulating at this point and, and, and to, to, to the extent you can you know, put the picture together on you know, the, the correlates that you're working with with the FDA and how, you know, learnings from there could be helpful in expediting these, these next generation candidates.

Yes, very good question. So we have shared a little bit of that data in mice. And what we have seen is that both the G one and G 24, what we call next generation constructs seem to be much more potent in terms of listening antibody responses to either G one or G 24. I think the, the key thing is that what we have found and we've applied throughout our platform is that if we made small changes to the way that the backbone is set up and some of the structures, we've seen substantial improvements in igenity in preclinical models. Obviously, we plan on testing at some point, you know, these things clinically, you asked another question about the correlate and yes, we've had identified a couple of things that are very important from the standpoint of predicting protection from norovirus from the G 11 challenge. And that those learnings can be, make it a lot easier to apply to doing your process optimization or clinical development. Because if you know what to look for, it makes it a lot easier to get to the finish line. And potentially when you look at the new constructs to know whether you're substantially going to improve the efficacy, you know, for the study. So yes, all of our learnings in the original G 11 challenge and the things we have been discussing with the FDA are applicable to either new or nextgeneration constructs.

Did you say the timing for these constructs from an IND standpoint? I know manufacturing can go very quickly for you guys. But are you guiding for an I&D filing timeline?

We provide any at this time and you know, as things as we, as we develop our thing, our constructs further, we'll let people know.

Great. Thanks for your questions.

Thank you. Our next question comes from the line of Liang Chang with Jeffrey. Please proceed with your question.

Hey guys, thank you for taking our questions. This is Li Chen for Roger from Jeffrey. I guess my first question about the COVID program. So just wondering, do you expect any impact on the enrollment given, you know, thinking about the finality of the COVID? And also, you know, do you think there would be any impact on the infection rate? You know, considering now it's in a November and you are considering six months enrollment, six months to complete enrollment.

Yeah. Thanks for the question. In terms of enrollment. I can tell you what we're seeing right now is we haven't seen any slowdown of enrollment with the Sentinel cohort based on our projections and we work very closely with study sites and our cr there hasn't been any feedback that says that we should be generally concerned about enrollment. So from our standpoint, it's all systems go and I'll turn over to Sean for his comments.

Yeah, I mean, I guess you asked the question about infection rate and new variants. Well, obviously things are keep as with all COVID vaccine development, the strains that are circulating change quite rapidly and over three or four months, there'll be new, you know, strains I think right now it's KP three is circulating most prevalently. But I mean, this is just the way it works with COVID. You know, again, one of the things that we like about our platform is that we create these cross reactive mucosal IGA responses and we think that they'll be beneficial in the long term, you know, as the variants show up.

Thanks for for the answer. So also about the No virs program. So I just wonder what, you know, what data FDA requested. Can you provide any color on that?

Yeah, we're not commenting on specific requests or requirements, you know, right now we're trying to assess, you know, what the guidance we did get, which we do think we got additional clarity about what it takes to get to a have a successful end of phase two meeting.

Got it. Makes sense.

Thank you.

Thank you.

And we have reached the end of this portion of the Q&A session and I'll now hand the call back over to Ed Berg.

Thank you. We have some questions from our retail investors that's been sent in. I'll start with one that we partially answered, but I'll ask Sean to, ate a little more. How quickly can you start the 10,000 participant phase of the trial? I think some of this gets to the, the timing and the review by FDA and DNB.

Yeah. Well, the company's goal is to rapidly enroll in the Sentinel cohort. I think things are going well. And as we mentioned, in previous remarks, we expect it to be completed pretty soon this month actually, after enrollment completion and upon a favorable review by the independent DSMB and FDA of that 30 day safety data, our plantiff immediately start enrollment in the second phase of the trial which we currently anticipate in early 2025.

Thanks.

Another question about the, the trial that was sent in is the infrastructure prepped for the trial to begin, including recruiting.

Yeah. Well, thanks to the hard work of our dedicated team. We are well prepared to initiate the second part of the trial upon favorable review of the 30 day safety data from the independent DSMB, as well as the FDA. We are really confident in our ability to deliver both investigational and compare our vaccine to sites and have worked very closely with our cro to ensure site readiness. And of course, we already have a number of active sites that have randomized participants for our sentinel cohort with many additional sites ready to participate in the next phase.

Thank you one more question Neuro Vrus program. You may have fully covered it, but I'll put it out there on your neuro biased program. What's your most logical? Next step?

Again, our goal is to have an end of phase two meeting with the FDA and discuss requirements for phase three and licensure. But to get there, we do need to add more data to our overall package. We will continue to be thoughtful and deliberate in this approach and ensure that we can build the most compelling data package for the FDA.

Thank you a question for Steve. Would you consider conducting a trial outside of the US, potentially with a partner?

Yes, we're always open to collaboration with companies to co develop our platform and also nondilutive funding opportunities with entities outside the United States if it makes good business sense. So our vaccines development have the potential to have an impact in the United States but also around the world. So we're definitely open to broader partnerships. And as an example, you know, Sean mentioned earlier, we had conducted our phase one norovirus trial in Lactating Mothers in South Africa, which was funded by the Bill and Melinda Gates Foundation.

Thanks. Another question. This is for Sean. Do you have additional updates regarding your earlier stage programs such as seasonal flu HPV or avian flu?

And we can we anticipate any preclinical data?

And are you prioritizing one program?

Yes. Well, we are currently conducting preclinical work on Avian flu, seasonal flu, and HPV. As for bird flu, our previous data showed our platform may potentially be effective for various strains of bird flu. Although we have not conducted any studies of the current circulating strains, the ones that are in the US. Additionally, we published a paper in vaccines which I mentioned before about our HPV constructs and we regularly review our candidate pipeline to determine the best strategic opportunities. The company makes these decisions based on a variety of factors including market and competitive dynamics, resources and timing.

In addition to these programs, we will continue to conduct pre clinical development of novel constructs to grant both current and emerging infectious disease threats for pandemic preparedness.

Thank you.

That's all the questions we have at this time, I'd like to turn the floor over to Steve Lowe for some closing remarks.

Yes. Thank you everyone for joining us on today's call at Vaxart. We are working with great effort in pursuit of revolutionizing how we think about global public health supporting vaccine development is not only an investment in health but in the resilience and prosperity of our global community. We are proud to be introducing innovation in the vaccine space. As pioneers in oral vaccines, we believe our differentiated approach that focuses on mucosal immunity will be key to our success. So we continue to be optimistic about our promising future and look forward to updating you all on our progress. Operator. You may close the call.

Thank you. And this concludes today's conference and you may disconnect your line at this time. Thank you for your participation.