Vaxart, Inc.

Greetings and welcome to the VaxArt Business Update and Third Quarter 2025 Financial Results Conference Call. The question and answer session will follow management's opening remarks. 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 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 factors section of VaxArt's most recently filed annual report on Form 10-K and 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 program developments. Jerome will then share an update of our financials. And finally, I will have some closing comments before we open the call for your questions. Starting with our COVID-19 clinical program, Last week, we were excited to announce an important value-creating partnership with Dynavax, a commercial-stage biopharmaceutical company that has a proven track record in commercializing innovative vaccines. As part of the agreement, VaxArt could potentially receive up to $700 million in total license, regulatory, and milestone fees, as well as royalties for our oral COVID-19 vaccine candidate. This is a major milestone for the company and this program, which validates the potential of our platform and will provide critical non-dilutive capital that will help us advance this program forward. Here are some of the important terms of the agreement. Dynavax will pay VaxArk an upfront license fee of $25 million and make a $5 million equity investment in VaxArk at a per share price premium to market pursuant to the terms of the securities purchase agreement. Combined with our current cash position, our cash runway now extends into the second quarter of 2027. DynaVax will receive an exclusive worldwide license to develop and commercialize oral COVID-19 vaccines based on VaxArt's delivery platform. VaxArt will retain full operational and financial responsibility for the oral COVID-19 vaccine program through the completion of the ongoing Phase 2B clinical trial and the subsequent end of Phase 2 meeting with the FDA. In addition, after receiving the results of the Phase 2B clinical trial, Dynavax will pay an additional fee of $50 million to Vaxart if Dynavax elects to assume responsibility for continued clinical development of the oral COVID-19 vaccine program. Finally, if DynaVax elects to assume responsibility for the continued development of the oral COVID-19 program, VaxArt may be entitled to receive up to $195 million in potential future regulatory milestone payments, up to $425 million in potential future net sales milestone payments and tiered royalties at rates in the low to mid teens on potential future net sales of our oral COVID-19 vaccines. We believe this collaboration is extremely important for VaxArt as a company. It not only extends our cash runway, but it speaks to the potential of our oral vaccine platform, which could be a major differentiator versus other vaccine delivery methods. Later on, James will highlight details of our Phase 2b progress, but we remain on track to announce multiple datasets in 2026. We appreciate Dynavax's view that COVID-19 remains prevalent in society as infections, hospitalizations, and even death persist, and that the new solutions are in order. At the present time, there are very few deals in the vaccine space, and we appreciate Dynavax's investment and expertise, which can assist in moving this project forward to approval. Partnering with Dynavax will also allow Vaxart to become better positioned for late-stage development on other indications. To reiterate, this is a major step forward for the company. We also appreciate that Dynavax shares our view that our innovative approach could potentially transform global public health and revolutionize distribution and administration. We look forward to sharing updates on our progress and collaboration in the future. Turning to our norovirus program, as we previously shared, we were pleased to report positive phase one top line results from our second generation constructs, which demonstrated this vaccine technology produced much stronger antibody responses compared to our first generation constructs. Since this positive top-line data update, we have presented at multiple medical conferences, highlighting the statistically significant increases in G11 and G24 norovirus blocking antibodies, as well as other analyses from the study, which underscores the potential for protection that the new constructs provide. Sean will share more details of our compelling norovirus data shortly. Norovirus continues to be a leading cause of acute gastroenteritis worldwide, causing significant morbidity and mortality in countries of all income levels, particularly amongst young children and older adults. At an economic cost of more than $10 billion in the United States alone, there remains an urgent need for a safe and effective norovirus vaccine. We believe that our norovirus vaccine candidate 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. We remain eager to advance this program and continue to dialogue with several interested parties since our last update. While we are committed to securing a partnership, Please understand that these discussions are predicated on other parties' timelines, not just ours. As a result, we now anticipate initiating the next clinical trial in 2026, provided that we receive funding. To recap, with multiple programs, we look forward to further demonstrating the strength of our oral vaccine program. Now with a partner in Dynavax, we can further advance our COVID-19 program pending two potentially robust data readouts in 2026. With a platform designed to generate both systemic and mucosal immunity, 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 Dr. Cummings for a review of our COVID-19 clinical program. James? Thanks, Steve.