Vaxart Inc (VXRT) 2023 Q3 法說會逐字稿

Greetings, and welcome to the Vaxart Business Update and Third Quarter 2023 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.com. As a reminder, this conference is being recorded.

I would now like to turn the webcast over to your host, Ed Berg, Senior Vice President, and General Counsel. Please go ahead Ed.

Good afternoon, and welcome to today's call. Joining us from Vaxart are Andrei Floroiu, Chief Executive Officer, Dr. James Cummings, Chief Medical Officer, Phillip Lee, Chief Financial Officer, and Brant Biehn Senior Vice President for Business Operations.

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, and its product development and regulatory progress, including statements about its ongoing or planned clinical trials.

Actual results could materially differ from those discussed in these forward-looking statements due to a number of important factors, including uncertainty inherent in the clinical development and regulatory process and other risks described in the Risk Factors section of Vaxart most recently filed annual report on Form 10K 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 Andrei Floroiu. Andrei?

Thank you, Ed, and thank you to all of you for joining us today. On today's call, we'll highlight the recent clinical progress we have made on our norovirus oral pill, vaccine program. We will also provide a look at our planned milestones and briefly discuss our COVID program before opening the call to your questions.

During the third quarter, we took important steps to validate our mucosal vaccine platform. We released encouraging top line data from two, Phase 2 trials of our norovirus program. First, from our Phase 2 dose-ranging study for our bivalent norovirus oral vaccine candidate, and then from our Phase 2 norovirus challenge study.

The data we generated from both of these trials will drive the next steps for this program, which we believe has the potential to transform both how we think of norovirus and the vaccination paradigm, as we know, James, will go over the scientific findings from these trials in more detail.

But before hand, there are a few key points I'd like to share in terms of what we have learned at this stage of our norovirus program. First, our oral pill vaccine candidate has the potential to reduce the rates of norovirus infection, acute gastroenteritis, and viral shedding.

These were key results from our recent challenge study. We believe that when we substantially reduced shedding, we dramatically, slow down the rate of transmission. That is an incredible potential benefit of the vaccines.

Second, we believe these data validate the potential of our oral tablet norovirus vaccine program. We now have completed eight clinical trials for norovirus, all of which showed that our vaccines induced strong immune responses and are safe and well-tolerated with no vaccine-related serious adverse events. We are confident in Vaxart�s platform and our norovirus program specifically as we aim towards a registrational Phase 3 study.

And third, we believe we have established clinical proof of concept for our, oral pill platform via now two human challenge studies, one for norovirus and the other for influenza. In each case, we demonstrated that our oral pill vaccine technology has a clear and consistent impact on a number of important metrics such as reducing the rate of infection, illness and shedding.

We continue to believe we have the most advanced norovirus vaccine candidate in clinical development that is both formulated for oral administration and designed for delivery to the gastrointestinal system. A pill vaccine could truly change how we vaccinate global, how we make vaccine, how we distribute them and how we administer them.

Not to mention that also, that many more people will take vaccines that are not middle days. While the more remote regions of the world could have accessed on oral pill that doesn't have the cold chain and infrastructure requirements of injectables.

I want to emphasize the impact of the disease we are fighting against. Norovirus recently was named the leading cause of foodborne illness during the joint Food and Agriculture Organization and the World Health Organization expert meeting on Microbiological Risk Assessment in Rome, Italy.

And norovirus is the leading cause of gastroenteritis. This is a disease with an economic burden in excess of $10 billion annually in the US alone and of over $60 billion globally. Norovirus infections affect young children and the elderly disproportionately.

Recently, we dosed the first subjects in our previously announced clinical trial to evaluate the ability of our norovirus vaccine candidate to induce antibodies in breast milk and transfer of antibodies to young infants. We are excited about the potential for this study as Vaxart oral norovirus vaccine pills may make it possible for mothers to protect their infants against this highly contagious disease that has serious health consequence.

And now for a brief update on our COVID-19 program, we continue to make progress on a potential COVID vaccine. And we believe the cross-reactivity all of our current construct suggests a pathway for developing a pan coronavirus vaccine.

Several recent forecasts project new COVID variants to continue to appear exacerbating the persistence of this serious threat to public health. Given our prioritization of the norovirus program, we are assessing next steps for the COVID program, which could include a number of options. We look forward to providing information once we determine the path forward for this important program.

I'll now turn the call over to James to review the recent progress for our norovirus program.

Thanks, Andrei. We made great clinical strides in our norovirus program during the third quarter, announcing top line data from two separate Phase 2 trials. We believe the data that we've shared to date is promising for this vaccine candidate and for our vaccine platform overall.

I'd now like to provide you with a high-level summary of both studies. First, I'll start with the data from our Phase 2 dose ranging study of our bivalent norovirus vaccine candidates. Recall that this candidate contains two genotypes, G11 and G24, both of which have caused the majority of norovirus disease in humans over the past 20 or so years.

The primary endpoints for safety and immunogenicity in order to determine a dose level for our Phase 3 development. The preliminary results of the trial showed robust serum immune responses across all doses at day 29 relative to day one.

Both vaccine doses showed a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms at day 29, increases in serum IGA, serum IGG and BT50 for both the G24 and G11, strains in the vaccine arms we're similar to those seen in previous norovirus studies conducted by Vaxart.

These results also demonstrate that the bivalent norovirus vaccine candidate was well tolerated with a favorable safety profile that included no vaccine-related serious adverse events or SAEs and no dose limiting toxicity. Adverse event rates for both doses were similar placebo.

Turning to the Phase 2, G11 norovirus challenge study, which measured the safety, immunogenicity, and efficacy of our monovalent norovirus vaccine candidate. The primary objectives were to determine the clinical efficacy of our monovalent norovirus vaccine candidate compared to placebo to protect against norovirus acute gastroenteritis or AGE, caused by the Norwalk strain challenge inoculums.

And to evaluate the VP1 specific IGA antibody secreting cells, or ASCs, the HVGA, blocking antibody and the VP1 specific serum IGA and serum IGG responses to the vaccine. This was a double-blinded, randomized, placebo-controlled study in which healthy volunteers received a single oral dose of our norovirus vaccine candidate that targets the G11 strains of norovirus or they received placebo on day one.

On days 29 and 30 participants were challenged with the G11 strain of norovirus and then assessed for infection, norovirus AGE and the immune responses, through day 57. This study met five of its six primary endpoints. The results show a statistically significant 29% relative reduction in infection or 21% relative reduction in norovirus AGE, that was not statistically significant and an 85% relative reduction in viral shedding, which was a pre-specified study endpoint in the vaccinated cohort compared with placebo.

As we noted in the data announcement. We believe these results support the potential for our norovirus vaccine program to provide significant public health benefits. We also believe these are important findings that support the potential use of our oral pill vaccine technology in enabling a vaccine for norovirus.

As Andrei mentioned, we dosed the first subject in our Phase 1 clinical trial, evaluating Vaxart's oral pill bivalent norovirus vaccine candidate focused on safety and immunogenicity and lactating mothers. This is an important step towards Vaxart's goal of developing a vaccine that may reduce the significant global health threat norovirus poses, especially to children under five years of age.

Norovirus sickens, approximately 21 million people in the United States each year and 15% of children under age five contract norovirus annually. We believe an oral pill norovirus vaccine may make it possible for mothers to protect their infants against this highly contagious virus.

In terms of next steps for the norovirus program. Additional analyses of the data from our previous norovirus trials are ongoing, and these will help us in determining how we go forward.

Next steps for registration will include a Phase 2b dose confirmation study of our bivalent candidates in order to obtain sufficient safety data to inform an end of Phase 2 meeting, with the FDA in the United States we remain on track for the FDA meeting by the end of 2024.

And I'll now hand the call over to Phil Lee, our Chief Financial Officer, for a brief discussion of our financials. Over to you, Phil.

Thank you, James. The details of our financial results for the third quarter of 2023 are summarized in today's press release. Revenue for the third quarter of 2023 was $2.1 million compared to no revenue in the third quarter of 2022.

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. Vaxart ended the third quarter of 2023 with cash, cash equivalents, restricted cash, and marketable securities of $53 million compared to $67.9 million as of June 30, 2023. The decrease was primarily due to cash used in operations as we advanced our program, the company continues to anticipate current cash runway into the third quarter of 2024.

Thank you all for your time today. We will now open the call for your questions.

Thank you. (Operator Instructions) Our first question today is coming from Mayank Mamtani from B. Riley. Your line is now live. Please proceed.

If I can ask a couple of clarifying questions on the correlate of protection, additional analysis that is going on just maybe we get, if there's any color there you can share. And are you looking at both the monovalent and bivalent data sets for the correlate of protection and you need this for the Phase 2b dose confirmation study? Thanks.

Thank you. This is James Cummings. I'll take those. So in terms of the correlate of protection, we're continuing that analyses from our challenge study. As you may recall, that challenge study was a monovalent vaccine versus a matched monovalent strain of challenge inoculum.

As we mentioned, we're confident we'll have a correlate of protection, and that analysis is ongoing. When it comes to the data sets that are being used, we certainly would look towards the challenge study as finding that correlate of protection.

We will certainly look at other studies and analyses from the past as to where that correlate lies. But the determination of the correlate is based on the challenge study at this time and then, how that might impact a Phase 2b or more importantly, a Phase 3 study would be based on dialogue with the FDA. What we hope to garner from a Phase 2 study at Phase 2b would be additional safety data to bring us to an end of Phase 2 meeting with the FDA, which is as I mentioned, still online for or still on scheduled for end of 2024. Thank you.

Thanks. Appreciate it.

Thank you. (Operator Instructions) Our next question is coming from Liang Cheng from Jefferies (technical difficulty)

Hey team, this is Liang for Roger Song. A couple questions from us. So I guess the first one is about potential Phase 2 or the Phase 2b study. So on any color around the study design in terms, of member of enrollment and timing and does?

This is James. I'll take that question. So the Phase 2b study design may be impacted somewhat by some of our further analyses but will be used to beef up the overall numbers for an end of Phase 2 meeting with the FDA.

That said, it would be somewhere along the lines of at least 400 or so maybe more individuals who would receive a test article and then moving forward. And that would be a direct look at the safety and immunogenicity of that study.

Thank you. So maybe another question on I remember, I think, I've mentioned that you'll potentially do another like bivalent challenge study. So what are the current considerations around that?

Certainly so currently we've done and reported on the norovirus G11, strain challenge and look forward to reporting in that further analysis out to the community. In dialogue with the FDA. We will then make a decision on moving forward with that correlate to impact the Phase 3 study design and if needed, an additional challenge study with G24, could be executed.

But at this time, it's not a requirement. If it were to be executed, it could be done in parallel with a Phase 2b study, we'll have more information on that once we have the correlative identified and have had those initial discussions with the FDA.

Got it. Thank you. Maybe one quick one on the Phase 1 study design. So I know you mentioned that the measurement of transmission reduction into a Phase 3 and the importance of that. So any feedback from the agent around that part for the transmission reduction?

Well, so what we had reported on was actually a large decrease in viral shedding, which we believe may lead to decrease in transmission utilizing standards of public health policies. That said, we only have the data on the viral shedding, which is statistically significant at an 84% relative reduction, that data would then be further gathered in a Phase 3 study.

Got it. Got it. Thank you. That's all from us.

Thank you.

Thank you. I would now like to turn the call back to Brant for further questions.

Thank you very much operator. So we've got a number of questions that have come in through various sources, from our shareholders and other interested parties. A number of them are norovirus related. I think we've had some of them answered already. There's certainly a lot of interest in how the correlate protection and also when a Phase 3 trial for norovirus is going to happen. But I think James, you've already answered those.

Here's one that I will ask you James a little bit more clarification on norovirus. The question is, can you provide us with an update in terms of where you are in analyzing the additional neural data, the path as it goes on to the path forward to a Phase 2b trial. But I think the timeline for additional neural data. That's most important here.

Shortening. So currently, we're evaluating more immune responses and data on an individual subject level within that study. We look forward to sharing those details of the analysis once completed.

Thank you, James. Andrei, here's one for you really talking about the future of the organization. The question is specifically, do you have plans in 2024 to introduce any new product candidates? Andrei?

Thank you, Brant. So as we look into 2024 our focus will remain on identifying the best ways to progress our existing clinical pipeline, which is now composed as many of you know, of the norovirus, the pan-coronavirus and the flu programs.

And we believe that doing this will create more than enough catalysts and opportunities for value creation for a company of our size.

Thank you, Andrei. Okay. We've got a number of questions about how much money we have. Phil, this one's going to come to you. Specifically the question is, do you intend to initiate the Phase 2b trial with existing cash or will you need to raise additional capital to fund this trial? Phil?

So just to recap, we are currently conducting additional analyses of the data of our norovirus trials. And once we have determined the path forward for the program will provide an update on next steps and that we may include updating our cash runway guidance if appropriate.

Thank you, Phil. Okay. Back to clinical and James, this one is on the lactating mother's study. So the question for the lactating mother's study, what is your timeline to top line data?

Thanks. We'll have a better sense of timing for data from this study as we move closer to full enrollment to date, we've been enrolled seven subjects into that study.

Perfect. And as an add-on, question to that as well, James, that please remind us how the data from the lactating mothers study fits into the overall development program for the norovirus candidate.

So immunizing lactating mothers may provide increases in the norovirus immunoglobulins in the breast milk, and that could help protect the nursing infant. And that's really part of our strategy to protect this vulnerable population.

Fantastic. Thank you, James. Lots of questions about this one. So Andrei, this one is coming to you about additional funding from outside sources, specifically BARDA or other cover US government. So I'll give you the question and there's a lot of ways this has been asked, but do you have an update on Project Next Gen funding? And could you still receive funding from BARDA or NIH for this program? Andrei?

Yeah. So, if we were to have a concrete update, we would have shared that with you. So we done, but we remain optimistic. We remain of the opinion, as we have said multiple times in the past that the US government should support our pan coronavirus program. Looking at the programs that have received funding as part of the next gen program.

We continue to believe that our pan coronavirus program should be supported because it does provide several potential advantages. Distinct advantages over those programs. So again, we remain of the belief that if the US wants to significantly improve, its ability to fight future pandemics. Our program should be supported, and we'll update you when we have any specific updates to share.

Great. Thank you, Andrei. James, another one for you back to the World Vaccine Congress. So the question is, are there any updates from the World Vaccine Congress that you can share? James?

Sure. Thanks. So, our data from the norovirus challenge was very well received when it was contrasted to what the impact of our candidate vaccine might be went up against natural infection. And the key part here is natural infection generally results from exposure to 10 to 100 virus particles.

Don't forget the challenge inoculant was 1 million virus particles. So we think it's likely that the overall protection level in a natural infection will be enhanced because there's far less virus to protect against.

Excellent. Thank you very much, Phil there is another financial question regarding the gate study. So the question to you, Phil is how much revenue is left to be recognized from the gate study and over what time is that? Phil?

Sure. Thanks, Brant. So we recognize grant revenue in the period of which the related costs are incurred and services are rendered. So at this point, we really have recognized the vast majority of the current grant from the Bill Melinda Gates Foundation as that's ready, I currently expect to recognize the remaining $79,000 in the fourth quarter of 2023.

Excellent. Thank you, Phil. Okay, and operator, that closes our Q&A.

Thank you. With that, does that closes this conference, if so then you may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.