Vaxart, Inc.

Greetings and welcome to the VaxArt Business Update and Second Quarter 2025 Financial Results Conference Call. A question and answer session will follow management's opening remarks. Individual investors may submit written questions to ir.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. Please go ahead.

Good afternoon. 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 Jerome Grassman, 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 Stephen Lowe. Steve?

Thanks, Ed, and thanks to all of you for joining us this afternoon. I'll begin today's call with an overview of our business, Then we'll pass the call to James and Sean for the latest developments of our clinical and preclinical programs. Jerome will share an update of our financials. And finally, I'll have some comments related to our stock listing before we open the call for your questions. Starting with our COVID-19 clinical program, last week we received a second stop work order notice on our Phase 2b trial from Advanced Technology International, or ATI, the Rapid Response Partnership Vehicles Consortium Management Firm funded by BARDA. Like the first stop work order, this came as a surprise to us without any advance notice. Unlike the first stop work order notice, when we had not yet enrolled anyone in the 10,000 participant cohort, we were glad that this came to us when we had already enrolled approximately 5,000 participants And the notice allows us to continue the study for those already enrolled. We continue to believe there is huge potential for our promising oral pill vaccine candidate for COVID. Enrollment for this trial was proceeding at a rapid pace since we dosed the first participant in late May. These trends highlight the strong public interest of our oral vaccine platform and for a safe and effective vaccine against the SARS-CoV-2 virus. We agree with Secretary Kennedy's priorities that include the development of safe and effective novel vaccine solutions, such as our oral vaccine platform. As a reminder, our trial is designed to assess the safety, immunogenicity, and efficacy profiles of our candidate against an mRNA comparator. This trial is specifically designed to provide head-to-head data with the goal of advancing broader and innovative vaccine technologies. Although we were trending towards fully enrolling this trial by mid Q4 as we had projected or even earlier, we remain encouraged about the prospects of the trial and our vaccine candidate since there will be data on about 5,000 participants. We remain in close touch with our BARDA partners and ATI as they indicated that a follow-up notice with further details will come. I'd like to express my appreciation for the work of our clinical teams and investigators across our sites as they continue the important follow-up work on this trial. We also thank the clinical trial participants whose strong interest is making this key study possible. COVID remains an endemic infection that has a morbidity and mortality profile that is more adverse than flu. And while vaccination has waned, the market opportunity remains quite significant. And of course, we anticipate that our differentiated mechanism of action, plus delivery as an oral pill, can change the trajectory of vaccine acceptance and convenience. Turning to our norovirus program, in June, we were pleased to report positive phase one top line results from our second generation constructs. which increased norovirus blocking antibodies in both the low and high-dose cohort, with the difference reaching statistical significance for the high-dose cohort. Compared to our first-generation constructs, our new constructs were optimized to generate stronger immune responses. We plan to share the complete results of the study in a peer-reviewed journal, but it's encouraging that our second-generation constructs have shown meaningful improvement on an important marker of protection against norovirus infection and that the data continue to show they are well tolerated with a benign safety profile. We believe this has first in class or best in class potential as currently there are no approved vaccines and other products in development do not have the unique profile as well as delivery advantages of our platform. With continuing outbreaks in the news and a significant burden on society, norovirus represents a significant unmet need. As we have shared before, norovirus is believed to cause 20% of diarrheal disease globally and is the leading cause of acute gastroenteritis or AGE worldwide. This highlights the public health potential of our oral norovirus vaccine. The healthcare economic costs of norovirus infection and associated AGE are estimated at 60 billion worldwide and $10 billion in the United States. This underscores why market research estimates the potential of a multi-billion dollar US market for a safe and effective norovirus vaccine. Following the release of norovirus top line data, our leadership team attended the Bile International Convention in Boston. We held many productive one-on-one partnering discussions throughout the conference. And while it's too early to share specific details about a potential partnership, I'm pleased to share that we have meaningful interest from many parties. We will share more information, of course, if a partnership is achieved. Finally, we are progressing our preclinical research in avian influenza. As Sean will highlight, our new avian influenza vaccine was 100% protective against death in a robust ferriclade 2344B challenge model, compared with 0% survival and placebo-treated animals. Based on our growing body of data, we believe there is potential for our seasonal and avian influenza vaccine candidates and plan to look for funding to continue development of these programs. Overall, our broad pipeline with programs in norovirus, COVID-19, and influenza have a number of upcoming value-creating milestones. With a platform designed to generate both systemic and mucosal immunity, we believe our oral pill vaccine has the potential to transform global public health and revolutionize distribution and administration. I'll now turn the call over to James for a review of our COVID-19 and norovirus clinical programs. James.