3/12/2026

speaker
Operator
Conference Call Operator

Greetings and welcome to the Backstart fourth quarter business update and year-end 2025 financial results conference call. A question and answer session will follow management's opening remarks. As a reminder, this conference is being recorded. We'd now like to turn the webcast over to your host, Ed Berg, Senior Vice President and General Counsel. Thank you. You may begin.

speaker
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 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 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.

speaker
Stephen Lowe
Chief Executive Officer

Steve? Thanks, Ed, and thanks to all of you for joining us this afternoon. I'll begin today's call with several business updates, and we'll then pass the call to James and Sean for the latest program developments. Jerome will then share an update of our fourth quarter and full year 2025 financial results, and I have a few closing comments before we open the call for your questions. Now, moving to our recent operational updates, VaxArt achieved several recent key milestones. First, we established a partnership with DynaVax for our oral COVID-19 vaccine candidate. Second, we expanded our clinical body of evidence by publishing the complete data set from the clinical study of our oral norovirus vaccine candidate in lactating mothers. And third, we continued to manage our costs as evidenced by our entering into a lease termination agreement that will provide significant cost savings by allowing us to terminate one of our leases early. As announced in November 2025, we established a partnership with Dynavax for our oral COVID-19 vaccine candidate. At the time of the announcement, we received a $25 million upfront payment and a $5 million equity investment, which was at a premium to the closing price. This partnership provides significant validation of our oral vaccine platform's potential coming from a company with a proven track record in developing and commercializing innovative vaccines. It also extends our cash runway. In late December 2025, Sanofi announced its acquisition of Dynavax, a transaction that officially closed on February 10th of this year. Sanofi is a global leader in the vaccine space, and we are pleased to be moving forward with Dynavax as a Sanofi company. Over the past three months, we have established a highly productive working relationship with our collaborators, and our focus remains on executing and completing the Phase 2b trial and delivering those results. Under the terms of our agreement, we will receive an additional $50 million if Dynavax elects to continue development following submission of the Phase 2b data to the FDA. We also remain eligible for up to $195 million in future regulatory milestones, $425 million in sales milestones, and tiered royalties in the low to mid-teens. This agreement represents a total potential value of up to $700 million in license, regulatory, and milestone fees, tiered royalties, and the equity investment. Previously, we discussed our commitment to managing our financial resources for maximum effect. This includes pursuing revenue generating business development agreements, such as our partnership with DynaVax. It also includes looking for ways to reduce our operating costs without compromising our ability to realize the potential value of our pipeline programs and platform technology. Towards this end, in December 2025, we entered into a lease termination agreement with one of our landlords, which will allow us to terminate one of our leases on May 15th, 2026, rather than March 31st, 2029. This accelerated termination will help to reduce our operating expenses and enhance our ability to focus our financial resources on advancing our LEED programs. I'll now turn the call over to Dr. Cummings for an update on the status of our clinical programs. James?

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