Vaxart, Inc.

Greetings and welcome to the VaxArt third quarter 2022 business update and 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 Bean, Senior Vice President of Business Operations.

Good afternoon and welcome to today's call. Joining us from FACTSART are Andre Florio, Chief Executive Officer, Dr. Sean Tucker, Founder and Chief Scientific Officer, and Dr. James Cummings, Chief Medical Officer. Before we get started, I would like to remind everyone that during this conference call, Baxart 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 trial. 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, 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. I'll now turn the call over to Andre Florio. Andre?

Thank you, Ed, and thank you to everyone for joining us today. We are pleased to have this opportunity to review with you our third quarter progress and showcase the transformational potential of our oral vaccine platform. I'd like to start with a financial update that I believe is of interest to our investors. In August of this year, our shareholders approved our proxy proposal that authorized an increase in our authorized shares by 100 million to 250 million shares. During the proxy voting process, many of our individual shareholders were concerned that passing this proposal would lead to an immediate and significant dilution. I'd like to put that concern to rest. In the third quarter, after passing this proposal, we issued only 1.8 million shares, proving that, as we promised, we will continue to be very prudent and opportunistic in issuing new shares. So, I'd like to again thank our shareholders for their support and tell them that their trust had not been misplaced. Let me tell you why we are very excited about the work we are doing at Vaxart and about the significant potential that Vaxart has both to make a big impact on how we fight infectious disease globally and to create significant shareholder value. Since the beginning of the pandemic, Vaxart has drawn a lot of attention to its COVID-19 program and for good reason. And while the potential of our COVID-19 program remains significant, even as the general interest in COVID-19 ebbs and flows, I would like to talk to you about the bigger story here. As a true platform company, VaxStar is much more than just its COVID-19 program. And there are two major parts to this bigger story. One is our other leading clinical program, Norovirus, which we believe represents a huge opportunity for VaxStar. The other is is the broader promise that VaxArts platform holds in transforming the vaccination paradigm globally. While my colleagues will tell you more about the Norovirus opportunity, let me illustrate this broader promise of our technology. Recently, I was invited officially to attend the upcoming G20 summit, more specifically the B20 portion of the G20. So this week I'll go to Indonesia to discuss with world political and business leaders the role that Vaxar's platform could have in global pandemic preparedness in shaping the future architecture of healthcare. Now, small biotech companies do not usually get invited to the G20. However, Vaxar did because of the transformational potential of its technology that addresses one of the summit's main areas of focus this year, how tomorrow's global healthcare architecture could help the world recover together, recover stronger, which is one of the motives of this year's G20. And the Indonesian government is just one of the governments that are interested in exploring the role our platform could have in improving pandemic preparedness for this pandemic and future one. Now, while I've shared these developments because I think they can help you paint a fuller picture of what is going on at Vaxart, and because the very real interest in the transformational nature of our platform and our programs. Our lawyers insist that I state the obvious. While we are hopeful that this interest will translate into tangible support for Vaxart, there is, of course, no guarantee that this will be the case. So, is all this interest justified? Well, we certainly believe so. and I would like to review with you the promise of Vaxart's platform, as told by the data that we have generated so far. First, using Vaxart's platform, we produced the only oral vaccine shown to be as protective as a living injectable in humans against the respiratory pandemic virus. This is a remarkable result. A pill that can be taken with a glass of water, protected as well as a commercial vaccine that needs to be administered by injection. And what makes this result even more interesting is that it showed that the oral pill protected by working very differently than the injectable. Vaxart vaccine produced 6 to 10 times less serum antibodies than the injectable. Yet it protected as well, presumably because it also activated mucosal immunity. Let me say this again. Vassar vaccine produced up to 10 times less serum antibodies than the injectables, yet it protected as well. This point is worth noting because in a needle-centric world, there is a tendency to assess our data using the same lens as that used for injectables, namely looking only at serum data. Yet, forgetting that other arms of the immune system, such as mucosal immunity, are also important contributors to protection. Second, the data we have produced so far across our multiple programs suggests that our vaccine candidates also trigger mucosal immunity and that our vaccine platform has the potential to offer advantages over injectable vaccine in four areas, broad cross-reactivity against variants, reduction in viral transmission, longer protection, and a more benign total obesity. Improvements on even one of these dimensions would be significant. Yes, our data to date suggests our vaccine candidates may well have the potential to improve on all four. Dr. Tucker will review this data in more detail, and you can now also find more on this in our new investor deck, which is available on our website. So for now, I would just like to quickly provide some highlights. What we think is very encouraging is that each of the four potential improvements is supported not by just one, but by multiple data sets from across our programs and trials. For instance, cross-reactivity against variants and other coronaviruses was shown in both our COVID-19 clinical trials, so in two of them. Reduction in transmission or in viral shedding was observed in flu and COVID-19 studies. Durable protection or immune responses were seen in flu, norovirus, and COVID-19 trials. And to date, the benign tolerability of the vaccine candidates we have produced using our platforms is supported by 15 clinical trials with more than 500 subjects. Therefore, we believe that the full promise of our platform should be assessed by looking at the totality of the data we produce across our many programs, rather than by focusing on any individual program. And, as I said, our platform's promise is much more than the potential of any single program, no matter how promising that program is. In conclusion, let me synthesize why we are so excited about where VaxArt is today. A truly transformational potential supported by growing data across programs, costable financial resources, a very strong team, and significant clinical readouts in 2023. These readouts include two human challenge studies in 2023, one for norovirus and the other for COVID-19. These catalysts are significant because challenge studies have efficacy endpoints, namely assessing whether vaccines can protect against infection rather than just looking at immune responses. And now I'll turn the call over to Dr. Sean Tucker to review our recent data in more detail. Then James Cummings, Dr. James Cummings, will discuss our clinical trial program.