Vaxart, Inc.

Greetings and welcome to the VaxArt second quarter 2022 business update and financial results conference call. A question and answer session will follow management's opening remarks. Investors may submit written questions to ir at vaxart.com. As a reminder, this conference is being recorded. I would now turn the webcast over to your host, Brant Behan, Senior Vice President, Business Operations.

Good afternoon and welcome to today's call. Joining us from VaxArt are Andrei Floriu, our Chief Executive Officer, Dr. Sean Tucker, our Founder and Chief Science Officer, and Dr. James Cummings, our Chief Medical Officer. Before we get started, 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, the extent and duration of the impact of the COVID-19 pandemic, and other risks described in the risk factor 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 this call except as required by law. I'll now turn the call over to Andre Florio. Andre.

Thank you, Brent, and thank you, everyone, for joining us today. As discussed during our call on June 22nd, Vaxart is committed to providing our investors with more frequent communication, and we are pleased to have this opportunity to review our recent progress and outline our upcoming milestones. This is, in fact, Vaxart's first quarterly call in many, many years, and it couldn't have happened at a better time. Our mission here at Vaxart is to realize the full potential of our oral pill vaccine class. which we believe has the potential to revolutionize vaccines, as well as how we think, how we vaccinate all around the world. Vaxart's vision is that of a world where oral tablet vaccines are a reality, allowing more people to be more easily and painlessly vaccinated faster with just a glass of water. The world where oral tablet vaccines provide superior protection by harnessing the power of mucosal immunity. And while oral tablet vaccines could offer tremendous benefits across the full spectrum of targeted applications, they could have a particularly significant improvement over needle vaccines during pandemics. Indeed, we believe that our oral tablet vaccines could revolutionize how we fight the current COVID-19 pandemic as well as future ones. It is this powerful vision, this immense potential that drives us here at Vaxart. Equally important, the same vision and potential has been generating impressive enthusiasm among our shareholders. And we would like to thank them for making Vaxart special or validating our purpose. We are very excited to be talking to you today. As I mentioned in our June 2022 investor webcast, I believe that VaxArt today is in the best position it has been in its entire 15-year existence, after undergoing a significant transformation over the past two years that allowed us to internalize key capabilities and strengthen our human capital, from the labs to the GMP suites to the management team. What this means is that VaxArt is now in the best position it has ever been to leverage the potential of our oral vaccine platform by progressing multiple programs in parallel. And this is happening at a time when the need for better next-generation vaccines could not be more clear. The COVID-19 pandemic in general, and the Omicron variants in particular, have exposed the multiple significant shortcomings of needle vaccines. And now monkeypox, is reminding us that COVID-19 is unlikely to be the last pandemic we'll see in our lifetime. The potential advantages of oral pill vaccines are significant, particularly in pandemics. More people will get vaccinated by oral pill vaccines, and mass vaccinations with an oral pill could potentially be done much, much faster than by needle. Furthermore, as my colleagues, Drs. Tucker and Cummings, will cover in more detail, the potential advantages of our vaccines go well beyond the oral pill format. By triggering mucosal immunity, our vaccines have the potential to offer broader protection against a wider array of variants and pathogens, to protect for a longer period of time, and to reduce transmission. Now, let me talk to you a little bit about two key clinical programs, COVID-19 and norovirus. One of the challenges of developing COVID-19 vaccine is doing so against a virus that continues to evolve, basically a moving target. We started developing our COVID-19 vaccine in a world that was dealing with just one strain. As more strains started to appear, we grew more confident that our oral tablet vaccine candidate would offer superior protection due to the cross-reactivity of mucosal immunity and the powerful T cell responses. We now believe that the best way to leverage this distinctive cross-reactivity is to aim for solutions with future-proof potential by expanding our portfolio to include constructs that also target the new Omicron variants of concern, BA.4 and 5, and to study those as both monovalent and bivalent constructs. Doing so could have multiple clinical and strategic advantages. It positions us better for our human Omicron challenge study in the UK. I remind you that this is the first such study announced worldwide. It positions us better relative to our needle-based competitors. As everybody started work on BA4-5 variants, only recently. And it fits the recommendations and expectations of regulators such as the FDA, which recently announced that boosters should target the DA45 variant. Therefore, we are very excited about the prospects of our enhanced portfolio and, as my colleagues will cover in more detail, about its future-proof potential. Now, let me turn to our other lead clinical program. During this quarter, we have also continued to make progress with our norovirus program by adding to the clinical evidence that continues to make us ever more excited about the prospects of this program. The recent data from our trial in elderly adults is very encouraging, as it suggests similar activity as in younger adults. This is not often the case with injectable vaccines, therefore providing yet another potential source of differentiation for our oral pill vaccine candidates and increasing our confidence as we continue our development. And now, I'll hand the call over to Dr. Sean Tucker to review the multiple advantages that our oral vaccine technology offers.