Vaxart, Inc.

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 Andre Florio, Chief Executive Officer, Dr. James Cummings, Chief Medical Officer, Philip Lee, Chief Financial Officer, and Brant Bean, 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'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 Andre Florio. 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 field 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 two trials of our Norovirus program. First, from our phase two dose ranging study for our bivalent Norovirus oral vaccine candidate, and then from our phase two 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 beforehand, 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 reduce shedding, we dramatically slow down the rate of transmission. That is an incredible potential benefit of these vaccines. Second, we believe this 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 induce strong immune responses and are safe and well-tolerated with no vaccine-related serious adverse events. We are confident in VaxArts platform and the Norovirus program specifically as we aim towards a registrational phase three 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 globally, how we make vaccines, how we distribute them, and how we administer them. Not to mention that polls show that many more people will take vaccines that are not needle-based while the more remote regions of the world could have access to an oral pill that does not 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 subject 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's oral norovirus vaccine pill may make it possible for mothers to protect their infants against this highly contagious disease that has serious health consequences. 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 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 you 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.