Vaxart, Inc.

Greetings and welcome to the VaxArt Business Update and First Quarter 2023 Financial Results Conference Call. A questions and answer session will follow management's opening remarks. Individual investors may submit written questions to ir.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.

Good afternoon and welcome to today's call. Joining us from VaxArt are Andre Florio, Chief Executive Officer, Dr. Shawn Tucker, Founder and Chief Scientific Officer, Dr. James Cummings, Chief Medical Officer, and Philip Lee, Chief Financial Officer. Before we get started, 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 Factor section of VaxART's most recently filed annual report on Form 10-K and 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. Andre?

Thank you, Ed, and thank you to all of you for joining us today. On today's call, our team will highlight the progress we have made on our norovirus oral pill vaccine program during the quarter. We will also discuss updates on our plan for an oral pan-beta coronavirus vaccine and showcase data that demonstrates the unique benefits of our platform. Starting with norovirus, Most notably in the quarter, we initiated our Phase 2 dose-ranging study for our bivalent norovirus oral vaccine candidate. We remain on track to deliver on our planned milestones for 2023 with anticipated data readouts for both the dose-ranging study and for our ongoing Phase 2 challenge study of our G11 monovalent norovirus vaccine candidate later this year. James will provide more details on both studies in a moment, but first, a quick reminder on why this program and these studies are so important for global public health and why we are committed to Vaxart oral pill norovirus vaccine approach. Norovirus is a significant public health issue, which leads to a significant economic burden 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. It is important to note that norovirus predominantly affects two age segments, children under the age of five and older adults. There are about 20 million kids in the U.S. and about 55 million older adults over the age of 65. Additionally, there are approximately 15 million other Americans who can benefit from a norovirus vaccine, such as healthcare and childcare service providers, bringing our total domestic market opportunity to approximately 90 million Americans. In the U.S., most people are concerned about salmonella or E. coli, but if you look at the total number of cases, norovirus is the most frequent foodborne illness by far. If you've been following current events, you know that everyone is at risk for norovirus in schools, workplaces, and many other places where people gather in large numbers. People who experience norovirus symptoms are missing school and work and are not able to perform their daily function. We believe that our norovirus vaccine program has the potential to address the need and the tremendous disease burden that norovirus carries. both in the U.S. and around the world. To date, we have produced data from six completed norovirus clinical trials that have enrolled nearly 350 subjects. These data have shown immune responses from our vaccine to be strong, long-lasting, comparable to natural infection from norovirus, and similar in both elderly and young adult populations. a result that generally is not seen with injectable vaccines. In March, we showcased our differentiated norovirus program on a virtual KOL call that we sponsored with leaders in the norovirus vaccine development. These experts shared their insights and perspectives on the global need for a safe, effective, and readily deployable norovirus vaccine. We hope that many of you were able to join this informative event as we continue to educate the financial community about the magnitude of the unmet need and the opportunity for a norovirus vaccine. A replay of that event is available on our investor relations section on our website at www.dactar.com. Looking ahead, we have several important clinical milestones this year, and we remain on track to achieve them. First, we expect to report top-line data from the ongoing Phase II dose-ranging study of our bivalent norovirus vaccine candidate in mid-2023. Next, we anticipate reporting top-line data from the ongoing Phase II challenge study of our G11 monovalent norovirus vaccine candidate 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 candidate to induce antibodies in breast milk and transfer those antibodies to young infants. Taken together, these milestones have the potential to support the continued advancement of Vaxar's norovirus program towards a Phase III trial, while also potentially providing further validation of the promise of our norovirus pill vaccine platform. Norovirus continue to remain relevant both nationally and globally, and we are encouraged by this opportunity to advance our oral pill vaccine technology. Now, I'll turn the call over to James for a review of our norovirus program. James?