Vaxart, Inc.

Greetings and welcome to the VaxArt Business Update and Fourth Quarter and Full Year 2024 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.

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 Philip 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 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 Factors section of VaxART's most recently filed annual report on Form 10-K and also on other periodic reports filed with the SBC. VaxART undertakes no obligation to update any forward-looking statements after the date of this call. I'll now turn the call over to Steven Lowe. Steve?

Thanks, Ed, and thanks to all of you for joining us this afternoon. On today's call, I will highlight our business progress. I'll then have James and Sean share updates on our clinical and preclinical programs. Then Phil will discuss our financial results before we open the call for your questions. At VaxArt, our mission is to transform global public health by developing next generation oral pill vaccines to support pandemic preparedness and provide Americans and people around the world with a revolutionary new option to how they receive vaccines. VaxArt built a robust body of data across multiple clinical studies, and we believe that our approach may provide important safety and immune response benefits compared to approved injectables. We have multiple programs in clinical development built on the strength of our oral vaccine platform. It is this platform that has generated promising data to date, harnessed in a pill formulation that can address many of the shortcomings of injectable vaccines. Our candidates have demonstrated broad immune and cross-reactivity responses, reduction in viral transmission and shedding, long duration of protection and immune responses, and importantly, a benign safety and tolerability profile. Across 19 clinical trials against seven different viruses, evaluating more than 800 participants, our vaccine candidates have shown favorable safety data. Starting with our COVID-19 program, as we stated previously, we received an award of approximately $460 million to conduct an approximately 10,000 participant head-to-head study against an available mRNA comparator. In November 2024, we completed enrollment of the initial Sentinel cohort of this study comprised of 400 participants, with 200 receiving VaxArts XBB strain COVID-19 vaccine candidate and 200 receiving an approved XBB mRNA vaccine comparator. In January, an independent data safety monitoring board recommended the study to proceed without modifications based on initial safety assessment of the 30-day data. On February 21st, we received a stop work order related to this BARDA-funded Project NextGen award from the U.S. Department of Health and Human Services, or HHS. We were not provided a reason for the stop work order. It halted all activities related to the planned 10,000 participant portion of the study and is in effect for a period of up to 90 days. Within these 90 days, the stop work order will either be canceled, extended, or work on this project will be terminated. To be clear, this does not apply to efforts associated with the 400-person Sentinel cohort of the study, and activities to monitor and further assess this cohort continue. VaxArt is aligned with HHS and BARDA's vision of improving efficiencies while protecting Americans from known and emerging disease threats, underscored by the progress we achieve with our oral vaccine pill candidates. We recognize and appreciate the importance of oversight, transparency, and fiscal responsibility in government-funded biomedical research, and we are committed to working collaboratively with Secretary Kennedy, HHS, BARDA, and other members of President Trump's administration as they evaluate their priorities, as well as the data supporting the 10,000 participant portion of the Phase 2b study and determine whether and how the study should move forward. We maintain ongoing communications with our contacts at BARDA, primarily as it relates to the Sentinel Group follow-up work. At this time, we do not have any new updates to provide on the 10,000 participant portion of the trial. We will provide an update when we have additional information. The company continues to work through the impact of the stop work order, including making necessary expense adjustments in order to extend our cash runway. Turning to our norovirus program, we are making meaningful progress on our key milestones, and we are pleased to have initiated a phase one trial earlier this month, evaluating our second generation oral norovirus vaccine constructs head to head against our first generation constructs. We believe this was a prudent and responsible path that aligns with the recommendations of FDA based on constructive conversations that we previously held with the agency. If the phase one trial is successful, the next step pending a partnership or other funding would be to conduct a phase two safety and immunogenicity study that could potentially begin as early as the second half of 2025. This phase two trial would be followed by an end of phase two meeting with the FDA. A phase three trial could then begin as early as 2026 pending a successful end of phase two meeting and funding. Currently, there are no approved vaccines against norovirus. This winter was particularly challenging with numerous reports of norovirus spreading across the United States and around the globe. Norovirus is not just a cruise ship virus, but one that is highly contagious and is the leading cause of acute gastroenteritis symptoms such as vomiting and diarrhea. This $10 billion annual U.S. economic burden can affect up to approximately 20 million Americans, further illustrating the unmet need that we are determined to meet. Finally, we continue to carefully review our preclinical programs before determining if further investment is needed to advance other indications. Two such indications that we are evaluating are our avian influenza and HPV vaccine programs. Sean will provide an update on these programs shortly. I'll now turn the call over to James to provide a further review of the recent progress for our norovirus program.