Vaxart, Inc.

Greetings and welcome to the VaxArt Business Update and Full Year 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, Ed Burge, Senior Vice President and General Counsel.

Good afternoon, and welcome to today's call. Joining us from VaxArt are Dr. Michael Finney, Interim Chief Executive Officer, Dr. Shawn Tucker, Chief Scientific Officer, Dr. James Cummings, Chief Medical Officer, and Sel 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 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 Dr. Michael Finney. Mike?

Thanks, Ed, and thanks to all of you for joining us today. It's a pleasure to be speaking with you at this exciting time in the company's development. As this is my first quarterly call with you, I will begin with a brief introduction of myself and my observations of our company, and then I'll transition the call to the rest of the team to move through our recent accomplishments, clinical programs, upcoming planned milestones, and full year performance. First, this is my second installment as VaxArt CEO, having served in a similar capacity from 2009 to 2011. I've been a VaxArt board member since 2007 and board chair since March 2023. Throughout my time with VaxArt, I've seen the company go through many periods of clinical and corporate growth and take on a variety of new challenges. Never have I been more confident in our team and in our trajectory than I am right now. I firmly believe 2023 was a transformational year for this company and our mucosal technology. We made solid progress on our oral vaccine platform, completing two phase two clinical studies for our norovirus oral vaccine candidates, and we have now established proof of concept in two challenge studies for both respiratory and GI viruses. Based on the totality of the data we have produced through these and our other reported clinical trials, I think it's clear what we have our hands on. Our oral pill vaccines hold a very real promise of offering several advantages compared with injectables, including the ability to vaccinate people faster, easier, and painlessly without the need for cold chain storage or trained medical professionals to administer the vaccines, as well as the promise of mucosal immune response. We've already determined in preclinical and clinical trials that our candidates have a favorable immune profile induce serum antibody and serum neutralizing antibody responses, induce potent T cell responses, create mucosal immune responses, and can inhibit virus shedding, which may have an impact on virus transmission. Looking at the current landscape, and particularly given our recent ARDA contract award, we are now poised to make a major stride forward with our COVID-19 program. James will go over the details of the preparations and the study design, but it is clear that the federal government believes we need better vaccines that harness the power of mucosal immunity to more strongly combat the current XBB and future variants of the virus. The first generation of vaccines was a start, but the virus has continued to evolve. We can do much better, and VaxArt is prepared to accept that challenge and demonstrate our technology's promise. At the same time, we're making steady progress on our Norovirus program. We've completed our analyses of the recent challenge study data and have identified a potential correlate of protection, which will inform our upcoming meeting with the FDA to discuss the optimal path forward for this program. We continue to believe we have the most advanced norovirus vaccine candidate in clinical development, and it's both formulated for oral administration and designed for delivery to the gastrointestinal. Norovirus carries a tremendous economic burden in this country and globally, And we look forward to creating an oral vaccine that eases this burden for millions of societies most vulnerable. Finally, I can say with great pleasure that last week we announced the appointment of a permanent president and chief executive officer, Steve Lowe. Steve brings a wealth of biopharma experience to VaxArt, with more than 25 years in healthcare, biotech, and pharmaceuticals, including more than 12 of those years in the C-suite. He's had a particular focus on development and commercialization, having helped two companies bring their first product to market. VaxArt is in a tremendous position to advance its mission. We are excited to add a high-caliber, experienced CEO to elevate this company to greater heights and create value for our shareholders. And currently, I will be stepping down as CEO and retaining my position as chair of the board. Steve joins VaxArt's effective March 18, and we are thrilled to welcome him. I'll now turn over the call to James to review the recent progress for our coronavirus program.