Vaxart, Inc.

Greetings and welcome to the VaxArt Business Update and Third 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 Byrd, 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, 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 factor section of VACSART's most recently filed annual report on Form 10-K and also on other periodic reports filed with the SEC. VACSART undertakes no obligation to update any forward-looking statements after the date of this call. I'll now turn the call over to Stephen Lowe. Steve?

Thanks, Ed, and thanks to all of you for joining us this afternoon. On today's call, I'm excited to highlight a number of accomplishments that we have achieved since our last update. I'll then have James and Sean share updates on our COVID, norovirus, and HPV programs prospectively. Then Phil will discuss our financial results before we open the call for your questions. When I joined VaxArt earlier this year, we set out clear objectives with the goal of advancing our oral pill vaccine platform and bringing a potentially transformative solution to improve public health. Not only does our platform show promise in addressing many of the shortcomings of injectable vaccines, such as using mucosal immunity to potentially block infection and transmission, but it also improves delivery convenience and has demonstrated a benign safety and tolerability profile across 19 clinical trials to date. In summary, we continue to see the potential for a truly differentiated and transformational platform. Today, I am pleased to report that we have achieved several milestones in executing on our goals. Starting with our COVID program, through our partnership with BARDA, we have taken a major step forward in finding a new way of confronting pandemics in the future. In September, we started enrollment in our Phase 2B study evaluating our COVID-19 oral pill vaccine candidate against an approved mRNA vaccine comparator. Interest for our trial is strong, and it is our goal to progress this study as rapidly as possible. James will discuss this trial in more detail shortly, but I would like to note that as recipients of one of the largest BARDA-funded Project NextGen awards to date, now valued at up to $456 million, we appreciate this collaboration and look forward to continuing our work with our government partners. As we track vaccination trends this season, we have seen COVID vaccinations increase substantially post-KP2 availability beginning in late August and early September. In fact, data that's tracked by Alcubia suggests that approximately 35 million people will receive a COVID vaccine dose in the US alone. This is comparable to last year's season of approximately 40 million doses. Based on these trends, It is clear that there remains robust demand for a COVID vaccine, and we believe that our solution can address this demand more efficiently and effectively than current injectable methods. Turning to our norovirus program, we have had fruitful communication with FDA and recently received constructive feedback on our data for potential correlates of protection. Sean will share a deeper dive of our assessment and planning. but I will note that we are taking a thoughtful approach in the best way to progress this program. We are meeting with a number of advisors and disease experts as we evaluate the best clinical development path. In addition to our conversations with FDA, we were pleased to have presented promising data of our trials at Infectious Disease Week and the World Vaccine Congress, underscoring our commitment to this significant unmet need. given that there are currently no approved vaccines against norovirus. This is a highly contagious virus and is the leading cause of acute gastroenteritis symptoms, such as vomiting and diarrhea, and sickens approximately 21 million people in the United States each year. It is one of our three pipeline programs with a multi-billion dollar market, and we are determined to advance this program forward. In addition to our two lead clinical programs in COVID and norovirus, we are continuing to look for the opportunity to advance our other programs with careful investment to further advance other indications. As an example, we recently published promising preclinical data on our HPV vaccine constructs in the August publication of vaccines, which suggests that our mucosal vaccine platform represents a possible non-invasive approach to prevent the progression to cervical cancer. We have additional preclinical studies planned to further characterize the immune-stimulating and anti-tumor activity of our HPV vaccine. We look forward to sharing updates from our BARDA-funded Phase 2B COVID trial, detailing the next steps in our norovirus program, and determining the best strategic opportunities for our other programs. I'll now turn the call over to James to provide a further review of the recent progress for our COVID-19 program.