Vaxart, Inc.

Greetings and welcome to the VaxArt business update and second quarter 2024 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.

Good afternoon. and welcome to today's call. Joining us from VaxArt are Stephen Lowe, Chief Executive Officer, Dr. Sean Tucker, Founder and Chief Scientific Officer, Dr. James Cummings, Chief Medical Officer, and Phil 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, 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 factor 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 Lowe.

Thanks, Ed, and thanks to all of you for joining us this afternoon. Today, I look forward to sharing updates on the recent progress that we have made for both COVID and norovirus programs and detailing our upcoming milestones. I'll then turn the call over to James for a more in-depth discussion of our planned BARDA-funded Phase 2b COVID trial and conversations with FDA for norovirus. Finally, Phil will cover our financial update before we open the call for your questions. Since I joined VaxArt in March, I've had the opportunity to spend time with all of the functions in our company and can confirm a deep commitment to advancing our science and to focusing on driving execution across the entire organization. It has been a strategic imperative of ours, particularly given the challenges of a biotech company that's innovating groundbreaking technology. This technology is also the reason why I joined VaxArt. I believe in the transformational potential of our oral pill vaccine platform. After five months as CEO, I have great confidence in our team who are hard at work with the goal of bringing solutions to solve some of society's greatest infectious disease threats. At the halfway point of 2024, I am quite pleased to report that we have delivered on the goals that we set out to accomplish by mid-year. Starting with our COVID program, as we announced in June, we were thrilled to receive one of the largest BARDA contracts to date under Project NextGen. The award, valued at up to $453 million, is through Project NextGen's $5 billion initiative by the Department of Health and Human Services to develop new, innovative vaccines and therapeutics that provide broader and more durable protection against COVID-19. Earning this award serves to highlight the promise of our platform. It also underscores the opportunity we have to reimagine how vaccines are manufactured and distributed globally and the urgency of our mission. As James will detail shortly, we continue to have an ongoing and productive dialogue with FDA, and pending their alignment, we will initiate this Phase 2B trial. Turning to our Norovirus program, We achieved meaningful progress over the past 12 months and are poised to take the next step in this program. In late April, we announced positive top line results for our phase one clinical trial focused on lactating mothers, which can potentially help us achieve our long-term goal of protecting infants through passive antibody transfer. As a reminder, this trial was partially funded by the Bill and Belinda Gates Foundation. In addition to these recent compelling data, we previously reported encouraging phase two results from our norovirus challenge study. Our norovirus program remains an essential component of our overall strategy and pipeline, and we continue to be confident that our program will yield positive results that will contribute to global health. Norovirus is a highly contagious virus and is the leading cause of acute gastroenteritis symptoms such as vomiting and diarrhea. It sickens approximately 21 million people in the United States each year, including 15% of children under age five who contract norovirus annually. Without an approved vaccine against norovirus, people will continue to miss work to care for their children affected with this disease. Furthermore, According to data from the NIH, adults at least 65 years old are at high risk for severe symptoms and clinical outcomes, including longer disease duration and death. The economic annual disease burden of norovirus is $10.6 billion in the United States alone. At this time, we continue to have an active dialogue with the FDA that includes sharing additional requested information. We look forward to continuing our constructive discussions that will help inform the regulatory pathway and clinical next steps for this program. Now I would like to touch briefly on our financial position. As a clinical stage biotech company, it takes significant financial resources to achieve our ultimate goal of commercializing a groundbreaking novel vaccine. By extending our runway in a 2026, we enhanced our capital position. allowing us to invest in innovation and continue to advance towards realizing our corporate goals. As pioneers in the oral vaccine space, we believe our differentiated approach that focuses on mucosal immunity will be key to our success. The promise of a mucosal vaccine that is cross-reactive against various strains may be better at preventing disease transmission, especially for mutating viruses, than existing vaccines. For public health, this is a crucial need in keeping people safe from infectious diseases. The science is still being proven, but we remain committed to advancing our programs. We look forward to keeping you posted on our ongoing discussions with FDA, sharing updates from our BARDA-funded Phase 2b COVID trial, and detailing the next steps in our Norovirus program. I'll now turn the call over to James to provide a further review of the recent progress of our COVID-19 and Norovirus programs.