Vaxart, Inc.

Greetings and welcome to the VaxArt business update in second 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, Brandt Bann, Senior Vice President and Business Operations. Thank you. You may begin.

Good afternoon and welcome to today's call. Joining us from VaxArt are Andre Florio, our Chief Executive Officer, Dr. Sean Tucker, our Founder and Chief Scientific Officer, Dr. James Cummings, our Chief Medical Officer, and Phil Lee, our 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 its product development and regulatory progress, including statements about its ongoing or planned clinical trials. Actual results could differ materially 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 Gloria.

Andre. Thank you, Brent, and thank you to all of you for joining us today. On today's call, we will highlight the recent progress we have made on our norovirus oral pill vaccine program. We will also look ahead to our remaining planned milestones for the second half of the year and briefly discuss our COVID program before opening the call to your questions. During the second quarter, we are pleased to report positive preliminary top-line results from our Phase II dose-ranging study for our bivalent norovirus oral vaccine candidates within our stated timeline. James will provide a review of that data and what it means for this potentially groundbreaking vaccine. It is important to point out that this data builds on the growing body of evidence that validates Vaxart's platform to explore the potential advantages of mucosal vaccination. All our vaccines are designed to trigger mucosal immunity, and this is a very important distinctive feature of our platform. The clinical data we have generated thus far across our multiple programs suggests that mucosal vaccination could provide several important advantages. Broader cross-variant protection, reduction in viral transmission, more durable protection, and a broader immune response through the activation of both serum and mucosal immunity. The other important distinctive feature of our vaccines is the oral pill format. The potential advantages of oral pill vaccines are so fundamental that making them a reality could radically change how we think about vaccines and vaccination globally. Oral pill vaccines would allow us to vaccinate a lot more people faster, more easily, and painlessly than we are doing today with injectable vaccines. This vision is the future of vaccination that we are working so hard to achieve. Across FACTSAR, we are excited about the potential of our norovirus vaccine program. We 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. Norovirus is a significant public health issue in developed countries, and there is no approved vaccine. More than 21 million people are infected in the U.S. each year, resulting in an annual disease burden of more than $10 billion in the U.S. alone. And the virus continues to be a leading subject of infectious disease stories across the country this summer, as the number of cases has spiked to at least a three-year high. We believe our Norovirus vaccine program has the potential to address this need and the significant, tremendous disease burden that Norovirus carries. Looking ahead, we have two important clinical milestones this year, and we remain on track to achieve them both. First, we anticipate reporting top-line data from the ongoing face-to-challenge study of our G11 norovirus vaccine candidates in the third quarter of this year. And then, we look forward to initiating this year the Bill and Melinda Gates Foundation-funded clinical trial to evaluate the ability of our norovirus vaccine candidates to induce antibodies in breast milk and transfer of antibodies to young infants. Before I turn the call over to James, I want to provide a brief update on our COVID program. To date, Vaxar's COVID-19 vaccine constructs have demonstrated a favorable immune profile. Vaxar continues to make progress on this program. And we believe, based on the new causal cross-reactivity data we have seen in our current constraints, that there may be a pathway to develop an oral pan-beta coronavirus vaccine. We are assessing next steps and will provide updates as they become available. Recently, the White House announced a new Office of Pandemic Preparedness and Response Policy. We are very encouraged by the US government's proactive approach to pandemic preparedness and strongly support global efforts to get ahead of the next global health crisis. As we cope with the post-emergency phase of the pandemic, we must build stronger defenses against future infectious diseases and other threats we will face. VaxHealth believes a cross-protective vaccine could improve our ability to fight future pandemics and is committed to that effort. As you can see, we strongly believe in the potential of our technology and what it could mean for global public health and are excited for the opportunities that lie before us. Now, I'll turn the call over to James for a more detailed review of our Norovirus program. Thanks, Andre.