Vaxart, Inc.

Greetings. Welcome to VaxArt Business Update and Full Year 2022 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, Brant Vian, Senior Vice President, Business Operations. Thank you. You may begin.

Good afternoon, and welcome to today's call. Joining us from VaxArt are Andre Floriu, our Chief Executive Officer, Dr. Sean Tucker, our Founder and Chief Science Officer, Dr. John James Cummings, our Chief Medical Officer, and Phil Lee, our Chief Financial Officer. Before we get started, I'd 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 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 Floriu. Andre.

Thank you, Brent, and thanks to all of you joining us today. We are pleased to share with you our corporate strategy update and talk about how we'll be progressing our transformational oral vaccine platform. As we said in the press release we issued this afternoon, we are prioritizing the development of our oral pill bivalent norovirus vaccine candidate as we believe this to be the best strategy to position Vaxar for long-term success and maximize shareholder value. Our goal of this strategy is to focus most of our investments on the programs that have the greatest near-term potential to validate and progress our oral pill technology platform. Norovirus represents a very attractive target for VaxArt because of the very compelling risk-reward profile of our program. I will highlight five dimensions here. The disease characteristics, the large commercial opportunity, the attractive competitive context, the compelling data we have generated so far, and our near-term data readouts. The key characteristics of norovirus as an infectious disease have not changed since we started working on our program, and we do not expect them to change. This is unlike COVID, which has been a constant moving target with emerging variants. Norovirus is less challenging for a company like Vaxar to develop a solution again. Second, the norovirus commercial opportunity is huge for a company of any size, an annual $10 billion disease burden in the US alone, with an estimated $60 billion burden globally. Third, competition for a norovirus vaccine is very limited. There is no approved vaccine anywhere in the world, and ours is the only oral programming development that we are aware of. And to our knowledge, there is only one other advanced programming development. Importantly, Our oral enterically delivered mucosal vaccine could have significant advantages for an enteric mucosal infection when compared to potentially injectable alternatives. Additionally, an oral pill vaccine has inherent convenience advantages in both key populations, kids and the elderly. The fourth point is that the data we have generated so far with our Norovirus program is substantial and quite compelling. We have completed six clinical trials and rolling 360 subjects in our Norovirus program. And this does not include the two ongoing phase two trials with top line data expected to read out this year. The immunogenicity data we have seen to date from the completed trials look consistently strong and the safety and tolerability data so far is benign. Additionally, as my colleagues will cover in more detail, our data in one key segment, the elderly, looks much better than what we would expect in this population, which is different than the data that has been seen with injectables. So we have a lot of concrete data points here to make us very excited about the potential for the clinical success of our norovirus program. We'll highlight many of these aspects over the next few months in both scientific and investor events. And fifth, we have two important top-line data readouts over the next six months. The first one is our phase two dose ranging study in mid-2023, and the second is our phase two challenge study in the third quarter. Now, besides that, importantly, we believe that if the data generated from our norovirus program continues to be strong, we'll have a range of value-creating options for taking the program forward. Mid- to late-stage vaccine assets addressing large markets are very attractive to many industry players, and these vaccine assets are quite rare, which is why at J.P. Morgan this year, we've seen that there is a lot of interest in this type of assets. So we believe this industry dynamic will translate into valuable optionality for us later on. Now, let me talk a little bit about our COVID-19 program. We continue to believe that the current injectable COVID-19 vaccines leaves a lot to be desired and that the encouraging data from our program suggests that our platform could fundamentally change how we fight COVID-19 and pandemics in general. That being said, we have had to adjust our strategy to the continuous evolution of the COVID-19 pandemic and the changing perspectives of important stakeholders, such as governments and regulators. Therefore, we decided to play to the strengths suggested by our clinical data and focus on addressing pandemic preparedness by developing a pan-beta coronavirus vaccine. One of the notable weaknesses of injectable COVID-19 vaccines has been their relatively narrow strain-specific activity. while cross-reactivity has been a feature of our mucosal oral pill vaccine. Such cross-reactivity will be essential for providing better protection against a virus that continues to evolve at a rapid rate and may escape the protection afforded by currently approved vaccines. Therefore, our broader focus on this beta coronavirus approach means we will not proceed with the previously planned clinical COVID-19 trials. And as we advance new vaccine candidates, we will determine the best development plan going forward. Furthermore, we remain engaged in discussions with regulatory agencies, governments, non-governmental organizations, and other strategic partners to maximize the value of all our vaccine programs. And we will provide updates as warranted. While we very much value every member of the Vaxar team, we have taken the difficult but necessary step to adjust our staffing level with a 27% reduction in workforce to reflect these new priorities and activities. With a change in program prioritization, our cash runway now extends into the second quarter of 2024. And as James will discuss in a moment, we expect to achieve several important milestones within the Norovirus program between now and then. These milestones have the potential to support the continued advancement of the Norovirus program toward the phase three trial, while also providing further validation of the promise of our oral pill vaccine platform. To showcase our differentiated Norovirus program and bivalent candidate, I am pleased to announce that we will be hosting a virtual key opinion leader call on March 28th at 1 p.m. Eastern Time with several leaders in the norovirus vaccine development. Sarah Bartsch, FICOR Project Director at the Research Foundation of the City University of New York, and Jan Vigne, Head of the National CalciVirus Laboratory at the Centers for Disease Control and Prevention in Atlanta. will share their insights and perspectives on the global need for a safe, effective, and readily deployable norovirus vaccine. And with that, I'll turn the call over to James for a review of our norovirus program. Thanks, Andre.