Vaxart, Inc.

Greetings and welcome to the Vaxart Business Update and First 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 Philip 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 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 today. On today's call, I'll provide a brief summary of my background, discuss our recent accomplishments, and share details of our exciting value proposition. I'll then turn the call over to James and Phil to review our recent progress, which includes positive data from our bivalent norovirus vaccine candidate in lactating mothers, upcoming milestones, and a financial update. Since this is my first quarterly results call as VaxArt's CEO, I'd like to begin with a brief introduction. I've spent most of my 25-plus year career in the healthcare, biotech, and pharmaceutical sectors, including more than 12 years as a C-level executive at publicly traded biotech companies. Throughout that time, I have led companies through all phases of drug development, from preclinical to launching and commercializing products. In my previous roles, I have worked firsthand in developing clinical programs and executing commercial strategies, experience that will be crucial as we advance VaxArt's pipeline. I enjoy working in biotech because it provides the opportunity to find the right healthcare solutions to society's most pressing unsolved problems. This is what led me to VaxArt, where I believe we have a promising science and a passionate team of scientific experts driven to bring transformative solutions to benefit public health globally. I am excited to lead VaxArt as we bring our pipeline of cutting edge vaccine candidates to improve outcomes in public health. A major emphasis of mine will be on execution so that we can deliver on VaxArt's promise more quickly in order to solve major public health issues while generating value for our shareholders. And now a couple comments on our pipeline progress. First, we are very pleased with the recent positive results from the phase one clinical trial evaluating our oral pill bivalent norovirus vaccine candidate in lactating mothers. The top line analysis from this study showed that our vaccine could significantly increase antibodies against norovirus in breast milk. This is an important first signal for the potential of our vaccine to protect against or reduce disease severity of norovirus in the youngest and most vulnerable population, as this virus carries a tremendous economic burden in the United States and other developed countries around the world. The next step for our norovirus program will be a meeting with the FDA in mid-2024 to review our clinical findings to date, which include our dose-raging phase two study of our bivalent norovirus vaccine candidate and our phase two challenge study of the G11 component of our bivalent norovirus vaccine candidate. We anticipate this meeting will assist us in determining the regulatory pathway and clinical next steps. Second, we expect to initiate our COVID-19 Phase 2B trial possibly as early as this quarter, once we are able to secure additional funding and gain regulatory alignment. We have been honored to receive an initial contract from BARDA and look forward to working with them on Project NextGen as we continue preparations for this trial. This phase 2B study will evaluate our oral pill, XBB, COVID-19 vaccine candidate against an improved mRNA comparator. We agree with the federal government that better vaccines are needed and believe these next generation vaccines will include those that harness the power of mucosal immunity like our innovative candidates. We look forward to providing an update on funding and our timing as events warrant. We are proud of the growing body of data that reinforces our confidence in our differentiated technology, and we continue to improve this technology. Recent preclinical data suggests our COVID-19 XBB construct has produced a more robust immunogenic response compared with our previous constructs. With these results, We are exploring whether certain changes we implemented in our XBB vaccine candidate will also be beneficial for other indications in our pipeline. We believe VaxArt is in an excellent position to seize the opportunity in front of us and advance our oral vaccine platform. Our data to date are compelling across respiratory and enteric programs, and we are determined to press on toward our goal of bringing these solutions to the populations that need them, both in the United States and globally. I'll now turn the call over to James to review the recent progress of our Norovirus and COVID-19 programs.