Vaxart, Inc.

Greetings. Welcome to VaxArt Business Update and First 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 at 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 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'd like to begin today's call by acknowledging our partners at BARDA and the Department of Health and Human Services and thanking them for engaging with us in the productive dialogue that has led to the listing of the stop work order on the 10,000 participant portion of our Project NextGen Phase 2B COVID-19 vaccine trial. We believe that the additional review and scrutiny of the trial design and the data supporting the safety and efficacy of our COVID-19 oral pill vaccine program will ultimately instill greater confidence in the study's results. We acknowledge that some of you have been frustrated that we haven't been providing real-time updates regarding our ongoing discussions with BARDA and HHS, and we have received many inquiries throughout this period as to our lack of communication with our shareholders. We certainly recognize the importance of timely and transparent communication with you, but we are limited to what information we can share due to our contractual obligations with BARDA and HHS and the confidential nature of these discussions. Adhering to those obligations is essential to the productive relationships we have established with both of these agencies and, as I hope you will appreciate, has been critical to the continued advancement of our COVID-19 program. In balancing the constraints of our Project NextGen contractor obligations with our SEC reporting requirements, we will continue to disclose material information in a timely fashion through our filings on Form 8-K and in those instances where we receive the necessary and timely approvals We will also issue press releases. GAINS will shortly provide an update on the status of the Phase 2b COVID-19 study and the actions we are taking to initiate patient dosing. But the bottom line is that we are delighted to be actively screening patients and are hopeful that we will begin dosing in the 10,000 participant portion of the study in the second quarter of 2025. Let me also add that we are operating under our current contract with BARDA, which has not changed and still provides up to $460.7 million for the Phase 2B study. James will also provide an update on our norovirus vaccine clinical program, but I want to note that we are pleased to have quickly completed enrollment in our Phase 1 trial, comparing our second-generation constructs with our first-generation constructs. While this is an open label trial, we are still blinded to all study results at this time. We expect to report top-line data from this trial in mid-2025 in line with our previously stated guidance. We continue to hold meaningful conversations with potential strategic partners who are closely monitoring this upcoming data readout. If the data prove our research thesis of an improved norovirus second-generation construct we believe it could lead to a partnership that would further advance the program and could provide further non-dilutive funding to the company. Taking a step back, we believe vaccines are essential for the infrastructure of public health. They are by many accounts, one of the top public health achievements in the 20th century. There are also major economic benefits such as lower costs to our healthcare system and increases in overall workplace productivity. Compared to pharmaceutical products, a vaccine can achieve a steady state of revenue at its peak, whereas a pharmaceutical can taper off earlier in its product lifecycle. Bringing a new vaccine to market is a lengthy, capital-intensive process, and as we continue to navigate the headwinds in the biotech environment, we had to make some difficult choices in order to achieve our upcoming milestones within our existing cash position. That includes rationalizing our costs through another round of workforce reductions in the past few weeks. It's not something we want to do, but it's unfortunately necessary for us to streamline our costs in order to maximize our future opportunities. Finally, as announced a press release issued earlier today, Phil Lee submitted his resignation as CFO for personal reasons. I would like to thank Phil for the valuable contributions he has made during his tenure at Baxart. We do appreciate his willingness to stay on as a non-executive employee for a few weeks to ensure a smooth transition for our incoming CFO, Jerome Grossman. We are very excited that Jerome has joined Baxart. A seasoned executive in healthcare and finance, Jerome brings more than 20 years of experience in biotech with his four most recent years at AltruBio, a clinical stage private biotech company. There, he was instrumental in leading finance and operations and helped scale the company for global clinical studies. Jerome also had successful stints at PACT Pharma, Intarsia Therapeutics, and Genentech. We look forward to working with Jerome and welcome him to our team. I'll now turn the call over to James for a review of our COVID-19 and Norovirus clinical programs. James.