VXRT - NASDAQ

Greetings, and welcome to the Vaxart Business Update and First Quarter 2024 Financial Results Conference Call. [Operator Instructions] Individual investors may submit written questions to [email protected]. 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.

Good afternoon, and welcome to today's call. Joining us from Vaxart are Steven Lo, Chief Executive Officer; Dr. Sean Tucker, Founder and Chief Scientific Officer; Dr. James Cummings, Chief Medical Officer; and Phillip Lee, Chief Financial Officer. 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 it's 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'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 Lo. Steve?

Thanks, Ed, and thanks to all of you for joining us today. On today's call, I'll provide a brief summary of my background, discuss our recent accomplishments and share details of our exciting value proposition. I'll then turn the call over to James and Phil to review our recent progress, which includes positive data from our bivalent norovirus vaccine candidate in lactating mothers, upcoming milestones and a financial update. Since this is my first quarterly results call as Vaxart's CEO, I'd like to begin with a brief introduction. I've spent most of my 25-plus year career in the health care, biotech and pharmaceutical sectors including more than 12 years as a C-level executive at publicly traded biotech companies. Throughout that time, I have led companies through all phases of drug development from preclinical to launching and commercializing products. In my previous roles, I have worked firsthand in developing clinical programs and executing commercial strategies, experience that will be crucial as we advance Vaxart's pipeline. I enjoy working in biotech because it provides the opportunity to find the right health care solutions to society's most pressing unsolved problems. This is what led me to Vaxart, where I believe we have a promising science and a passionate team of scientific experts driven to bring transformative solutions to benefit public health globally. I am excited to lead Vaxart as we bring our pipeline of cutting-edge vaccine candidates to improve outcomes in public health. A major emphasis of mine will be on execution so that we can deliver on Vaxart's promise more quickly in order to solve major public health issues while generating value for our shareholders. And now a couple of comments on our pipeline progress. First, we are very pleased with the recent positive results from the Phase I clinical trial evaluating our oral pill bivalent norovirus vaccine candidate in lactating mothers. The top line analysis from the study showed that our vaccine could significantly increase antibodies against norovirus in breast milk. This is an important first signal for the potential of our vaccine to protect against or reduce disease severity of norovirus in the youngest and most vulnerable population as this virus carries a tremendous economic burden in the United States and other developed countries around the world. The next step for our norovirus program will be a meeting with the FDA in mid-2024 to review our clinical findings to date, which include our dose-ranging Phase II study of our bivalent norovirus vaccine candidate and our Phase II challenge study of the G11 component of our bivalent norovirus vaccine candidate. We anticipate this meeting will assist us in determining the regulatory pathway and clinical next steps. Second, we expect to initiate our COVID-19 Phase IIb trial possibly as early as this quarter. Once we are able to secure additional funding and gain regulatory alignment, we have been honored to receive an initial contract from BARDA and look forward to working with them on Project NextGen as we continue preparations for this trial. This Phase IIb study will evaluate our oral pill XBB COVID-19 vaccine candidate against an improved mRNA comparator. We agree with the federal government that better vaccines are needed and believe these next-generation vaccines will include those that harness the power of mucosal immunity like our innovative candidates. We look forward to providing an update on funding and our timing as events warrant. We are proud of the growing body of data that reinforces our confidence in our differentiated technology and we continue to improve this technology. Recent preclinical data suggests our COVID-19 XBB construct has produced a more robust immunogenic response compared with our previous constructs. With these results, we are exploring whether certain changes we implemented in our XBB vaccine candidate will also be beneficial for other indications in our pipeline. We believe Vaxart is in an excellent position to seize the opportunity in front of us and advance our oral vaccine platform. Our data to date are compelling across respiratory and enteric programs and we are determined to press on toward our goal of bringing these solutions to the populations that need them, both in the United States and globally. I will now turn the call over to James to review the recent progress of our norovirus and COVID-19 programs.

Thanks, Steve. We're encouraged by our progress in both our norovirus and COVID-19 programs. First, on norovirus, late last month, we announced positive top line data from our Phase I clinical trial, evaluating the ability of our norovirus vaccine candidate to induce antibodies in lactating mother's breast milk. Recall that this study was partially supported by the Bill & Melinda Gates Foundation. We found in our initial analysis that antibodies to norovirus rose on average, 4.0 fold for the GI.1 virus strain and 6.0 fold for GII.4 virus strain in the breastmilk of lactating mothers who received the Vaxart vaccine candidate in the high dose group. Importantly, there were no vaccine-related serious adverse events and no dose-limiting pharmacotoxicity. These key findings may offer hope for mothers to protect their children against or reduce the effect of this highly contagious virus. While mucosal immunization of the youngest of children is challenging due to the nature of their developing immune system, our creative approach in the passive transfer of antibodies from mothers to infants could potentially improve infection resistance in infants. Globally, norovirus is a very serious illness with an economic burden estimated at more than $60 billion annually. It is particularly prevalent among the youngest age group, children under 8 years of age, as norovirus carries a tremendous rate of outbreak incidents compared with other infectious diseases. In the developing world, it carries a much higher mortality rate than in developing nations, especially in countries that already have a rotavirus vaccine program. Norovirus causes an estimated 50,000 child deaths every year, mostly in developing countries. As a reminder, this was a Phase I multicenter, randomized, double-blind, placebo-controlled, dose-ranging study designed to evaluate the safety, tolerability and immunogenicity of orally-administered biovalent, GI.1, GII.4, norovirus vaccine in healthy lactating females of at least 18 years of age. The study enrolled 76 subjects in 5 sites in South Africa. Subjects were randomized into high or medium dose vaccine or placebo groups. Safety data from this study remains blinded and will become available 12 months after enrollment. We are conducting additional analyses of the study data, and we expect to report more complete results, including other immunogenicity measures, in a future scientific manuscript. Looking ahead, as Steve mentioned, we are targeting a mid-2024 meeting with the FDA to discuss our data on potential correlates of protection as well as potential future clinical studies, such as a Phase IIb dose confirmation study and, if required, a GII.4 challenge study. We are hopeful that supporting safety data from a Phase IIb study could result in the end of Phase II meeting with the FDA that would focus on the scope and design of a Phase III pivotal efficacy study for our norovirus vaccine in adults over 18 years of age. Turning now to our COVID-19 program. We continue to make progress in preparing for a 10,000 subject Phase IIb clinical trial, evaluating our oral pill XBB COVID-19 vaccine candidate against an improved mRNA vaccine comparator. You may recall that preparations for the study were supported by a contract from BARDA and are part of the federal government's Project NextGen effort to enhance the nation's pandemic preparedness and better confront the continuing challenge of COVID-19. We have substantially completed the preparations of our manufacturing processes in advance of the launch of this trial. We're working to secure additional funding and regulatory alignment and if successful, we currently anticipate initiating this Phase IIb trial as early as the second quarter. As background, this is a Phase IIb double-blind, multicenter, randomized comparator controlled clinical trial to determine the relative efficacy, safety and immunogenicity of Vaxart's investigational oral SARS-CoV-2 XBB vaccine tablet against a currently approved mRNA needle injected booster vaccine in adults previously immunized against COVID-19 infection. I'll now hand the call over to Phil Lee, our Chief Financial Officer, for a brief discussion of our financials. Phil?

Thank you, James. The details of our financial results for the first quarter of 2024 are summarized in today's press release. Revenue for the first quarter of 2024 was $2.2 million compared to $0.7 million in the first quarter of 2023. Revenue in the first quarter of 2024 was primarily from revenue recognized or work performed under Vaxart's contract from BARDA and noncash royalty revenue from sales of Inavir in Japan. Vaxart ended the first quarter with cash, cash equivalents and investments of $36.7 million. While we did not receive any cash payments from BARDA during the first quarter, we have received approximately $1.6 million subsequent to the end of the quarter. We are in the process of executing on the remaining deliverables and permitting for the remaining $7.67 million [ as part of ] of our current BARDA contract, and we'll provide an update when we report our second quarter financial results. Based on our current plan, Vaxart anticipates current cash runway into late fourth quarter of 2024. Thanks, everyone, for your time today. We will now open the call for your questions.

[Operator Instructions] And our first question comes from Mayank Mamtani with B. Riley Securities.

This is Madison on for Mamtani. I wanted to ask, so maybe could you speak to what you need to demonstrate to procure this additional filing in order to initiate the Phase IIb BARDA. And maybe if you could speak to your confidence level on where you're at regarding -- obtaining those funds that are needed.

Yes. Thanks for the question. So I'll cover a few things, and then I'll turn it over to James on the specifics. In terms of confidence level, right? So the original award of the $9.27 million was to fund the preparation for the 10,000 subject study. And as both James and I have outlined, we made progress there. And I think you can even see in the financial results we've been reimbursed for some of that work. So that is why we continue to say that we're prepared to start the trial as early as this quarter. But let me also turn it over to James.

Thanks, Steve. In terms of the preparation for the study, I think the team has done an excellent job in putting together the pieces for evaluation of the XBB construct against an improved mRNA comparator vaccine. This is a big study. It's 10,000 people, right? And so to get all those food groups set up that -- it takes the team and we've got a good one. In terms of where we're at, we'll report back when we have those details for you. But we've been in close communication with BARDA on the preparations, and we plan to provide an update on funding and on our timing as applicable.

And our next question comes from Charles Duncan with Cantor Fitzgerald.

This is [ Alethia ] on for Charles. So we also have a question regarding the Phase IIb study for the COVID-19 vaccine. Can you talk about possible specific endpoints and criteria that will be used to evaluate its efficacy and safety against the mRNA vaccine comparator. And can you also elaborate on what enrollment for this study would look like, such as where you might enroll patients from? And are there any other challenges you might anticipate?

Sure. I'll turn that over to James since he has the details on that.

Sure. So as far as where we're actually executing the clinical trial, it's planned to be executed here in the United States. And in terms of enrollment, it would be healthy individuals, and individuals at risk above the age of 18. There's -- it's important that we test this vaccine against the comparator mRNA vaccine in a population that's likely to do the most good. So we're moving along those lines. What was the second part of your question, [ Alethia ]?

So it was about possible endpoints and criteria that you will be using for the study.

Yes. So the endpoints are safety always, right? And we're very fortunate in that our platform across every article in our pipeline portfolio has been very well received, very safe, and well tolerated. We'll also be looking at efficacy both for symptomatic COVID-19 infection compared to the comparator vaccine. And we'll be looking at the immunological readouts and mucosal readouts of that vaccine.

And our next question comes from Roger Song with Jefferies.

This is Liang Cheng for Roger. I guess from us, so I understand that you haven't met with the FDA yet. But regarding the potential Phase II challenge study. So what would be some considerations around whether there would be such a study or no? And also, I have a question about the potential immunology correlates. So could you remind us if you're still continuing on data analysis? And are there any updates or plans on the immunogencity correlates.

Sure. Yes. I'll turn it over to James shortly. My high level is, obviously, what we stated in terms of our meeting with the FDA is we're still targeting middle of this year, and James can cover a bit more about that.

Thanks, Steve. So as we mentioned, we'll be planning to -- we'll be meeting with the FDA in mid-'24. And we will review our clinical findings to date. That includes data on potential correlates protection. We anticipate this meeting will assist us in determining with the proper regulatory pathway and clinical next steps. And as I mentioned in my brief, some of these steps could include a Phase IIb dose confirmation study. And if required, a GII.4 challenge study. But I'd like to get input from the agency. We'll determine the timing of any future norovirus studies after our discussions with the FDA.

Got it. That makes sense. So also regarding the Phase I lactating mother's data, I know the detailed data will be published in future. Would there be any data around measurements in the infant?

James or Sean, either one of you want to take that?

Sure. So the data we have to date, Liang, is some of the top line data, and we continue to perform analyses. Some of those analyses will look at fecal -- the amount of material in the infant species. But that's, again, down the road a bit.

I would now like to turn the call back to Ed Berg for further questions.

Okay. Thank you. We have additional questions that came in from investors. So I will start with our Phase IIb COVID study. And this is for James. Do you have enough manufacturing capacity to produce your COVID vaccine for the Phase IIb trial?

Sure. Thanks for the question. Yes, we have sufficient material that's already been produced.

Thanks. The other question for you, James, on COVID, the COVID trial is how does the fall COVID-19 booster season affect Vaxart's ability to procure mRNA vaccines for use in the control arm?

Thanks, Ed. So this study is actually a comparator of homologous vaccines, 2 vaccines that are geared towards the same strain of the virus. We've already procured an XBB mRNA vaccine that is the comparator construct that we need for this trial.

Thanks, James. On the 108 study, this is for Sean. In your recent press release announcing the lactating mother's study data you mentioned antibody increased figures. How do these compare to the other published data?

Yes, that's a great question. Well, there haven't been as many studies have done where the women postpartum have been vaccinated. Most studies in mothers have done in third trimester, not after the infants born. Moreover, there haven't really been that many -- there has actually been no norovirus vaccine trials and lactating mothers. Having said that, from a few studies that we [ won't ] find on vaccination and post-partum mothers, we believe our results compare quite favorably. We're getting a similar response or better than what's been described.

Thanks. Sean, back to the -- this is one for Sean, but back to COVID-19 and the Phase IIb trial. The question is what differentiates Vaxart's technology from the other NextGen COVID vaccines that received contracts from BARDA?

Well, first off, we're the only oral pill vaccine that's currently been contracted in the Project NextGen recipients. The benefit that we see is that it's just more convenient to administer in our vaccine by injection or better than a nasal spray. The other advantage we have, of course, is as James mentioned before, we actually have our own manufacturing facilities and when they've been able to make vaccine quickly and it's a competitive advantage for us because of that.

Thanks. This one is also for Sean. And I think, Steve, you might want to step in and make some comments. The question is, how do you intend to educate the medical community and consumers on your COVID and norovirus oral vaccine benefits in order to rapidly drive adoption in the U.S., the U.K. and broadly, particularly given what has been learned about the shortcomings of existing vaccines in the overall vaccine hesitancy. And of course, I will -- as the lawyer, I will state that we don't. We're not going to be promoting our vaccines until they're approved. But there are other methods of communicating information. So Sean, with that, feel free to add...

Well, we think our tablet vaccine will do well from the standpoint of the overcoming vaccine hesitancy. In fact, we did do some previous polling data conducted in 2021 and 2022 and the later suggest that 8 out of 10 recipients would prefer a pill to a shot or a nasal spray. So further, we had gone -- we've gone to various medical conferences and congresses. And we have seen lots of positive feedback about our approach, and we think is indicative of the understanding of the medical community that there may be some pentup demand for a new technology that's easier to use. Steve?

Yes. Thanks, Sean. Sean is being modest. He gets invited to a lot of conferences to speak. And I think any sort of scientific exchange like that is important. And I think as we continue releasing more data, having that opportunity to do so is important to us. As Ed mentioned, we're not FDA approved as of yet. So we'll stick to the regular medical scientific exchanges to make sure that what we have and our data is out there for everyone to absorb.

Thank you, Steve. And a question directed to you. You mentioned in your prepared remarks having better execution. How do you think that can be accomplished?

Yes. Thanks for the question. Well, I think first and foremost, we, as a company, want to make sure that we have our priorities set, and I'm delighted to see that we have, as you've seen, already you heard today, we've talked about making sure that we execute on the agreement with BARDA to prepare for this upcoming 10,000 subject trial. And it's already been demonstrated with the fact that, as James mentioned, we have made great progress on the manufacturing front. We prepared and are preparing for the trial to the extent that you've heard more details about it. And so to me, that is continue to execute. We want to balance that with making sure that we're very rigorous with everything that we're doing, but also understanding that we want to help the public out there. So anything we can do to balance that with good speed is also important. And that's certainly how I look at having better execution.

Last question for Steve. It's been nearly 2 months since you arrived as CEO. What have you learned in that time?

Great. Thanks for that question. First and foremost, let me just say, I'm delighted to be here. What I have found and learned is that this is -- what we have here at Vaxart is very promising science. And one of the main reasons why I wanted to come here. And secondly, now that I've been here for 2 months, getting a chance to work side-by-side with the employees, our scientists, everybody. I can say that we are very passionate about our work and our mission. And if you combine the promising science with dedicated employees here at Vaxart, we are very focused on wanting to advance our vaccine candidates forward and get it out there as soon as we can with the approvals that we need and with the trials that we need to execute and conduct, but we are very focused on execution and also delivering value to our stakeholders.

Thanks, Steve. Thank you, everyone, for tuning in. I will turn it back over to our operator to close up the call.