Dynavax Technologies Corporation

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Third Quarter 2025 Financial Results Conference Call. As a reminder, this call is being recorded. At the end of the company's prepared remarks, we will open the call for questions and provide specific participation and instructions at that time. I would now like to turn the call over to Paul Cox, Vice President, Investor Relations and Corporate Communications. You may begin.

Thank you for participating in today's call. Joining me from Dynavax are Ryan Spencer, Chief Executive Officer, Don Cassell, Chief Commercial Officer, Rob Jansen, Chief Medical Officer, and Kelly McDonald, our Chief Financial Officer. Earlier today, Dynavax released financial results for the third quarter ended just September 30th, 2025. Copies of the press release and a supplementary slide presentation are available on Dynavax's website. Before we begin, I advise you that we will be making forward-looking statements today based on our current expectations and beliefs, including but not limited to potential market sizes, market segmentation, effective marketing efforts, future expected market share and related growth rates, and related ACIP recommendation impact on each. Financial guidance and trends, including revenue, profitability, cash flow, and sufficiency of current capitalization. timing and results of FDA submissions, clinical trial starts and data readouts, potential future uses of or demand for our CPG-1018 adjuvant, success of our strategic arrangements, including our license agreement with Vaxart, and anticipated benefits of our capital allocation strategy in general, including our share repurchase program. Our earnings press release in this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliations, on the investor section of our corporate website at dynabax.com. And with that, I will now turn the call over to Ryan.

Thanks, Paul, and thank you all for joining us this afternoon. I'm excited to review the progress and accomplishments that we've made this quarter. We've executed across all areas of our business, including driving another quarter of top-line growth and market share expansion for Hepless FBA. Advancing and creating momentum across multiple programs in our clinical stage pipeline. The execution of a strategic deal to access a Phase 2B COVID-19 oral vaccine candidate from Vaxart. Adding another near-term clinical catalyst in an area of high unmet need to our pipeline. And lastly, the authorization of a new $100 million share repurchase plan in connection with further clarity on our corporate progress and capital needs. This progress is underpinned by our continued commercial execution with $90 million in net product revenue this quarter from Hepatitis B, representing a 13% increase year-over-year while also further strengthening its leading market share position in the U.S. adult hepatitis B vaccine market. Hepatitis B remains a key focus for the organization, and we are excited to continue to grow the brand and we remain on track to achieve our long-term goal of at least 60% total market share in the U.S. by 2030. We've made meaningful progress this quarter, advancing our internal pipeline candidates towards key value-inflecting milestones. We're excited to progress our shingles vaccine program into Part 2 of the Phase 1-2 study, focused on adults age 70 years and older, which recently began enrolling and dosing. We look forward to sharing top-line immunogenicity and safety results from Part 2 and the 12-month follow-up data from Part 1 in the second half of 2026. We believe this data set is an important milestone and will provide the opportunity to explore strategic partnerships to realize the global value of this vaccine candidate. In addition to shingles, we've made continued advancements across the rest of our pipeline, including a new Department of Defense award for our plague vaccine candidate, and the completion of Part 1 of our Phase 1-2 study in pandemic flu. Rob will discuss the pipeline updates in more detail later on in the call. Beyond our operational success, we are also strategically deploying capital to expand our long-term growth opportunities. Earlier today, we announced an exclusive license agreement for Vaxar's novel oral COVID-19 vaccine program. The program has enrolled over 5,400 subjects and is currently in an ongoing phase 2B safety and efficacy study, comparing the vaccine candidate to an FDA-approved mRNA vaccine. COVID-19 remains a significant and ongoing public health challenge in the United States, causing widespread severe illness, hundreds of thousands of hospitalizations, and tens of thousands of deaths each year. Despite the availability of vaccines, millions of adults at increased risk severe disease remain unprotected, underscoring the continued need for innovation and better options for COVID-19 prevention. We're excited to work with Vaxart to advance this potentially transformative vaccine candidate. The Vaxart Oral COVID-19 Vaccine Candidate has the potential to provide improved protection through intestinal delivery, providing both systemic and mucosal immunity through a differentiated mechanism of action compared to the currently available vaccines. The head-to-head study is designed to show improvement over an existing mRNA vaccine, providing meaningful data to support disruption of the current vaccine market if successful. This transaction brings a novel vaccine program with high potential upside into our pipeline that will fully leverage our experience in late-stage development and commercialization. Importantly, the deal was structured to provide clear de-risking steps before significant future spend on Phase 3 development. Backstart will continue to run the ongoing study, and we will have the right, but not the obligation, to proceed with development following our review of the Phase 2b data and end-of-Phase 2 regulatory feedback. Backstart expects top-line data to be available by the end of 2026, with the end-of-Phase 2 meeting occurring thereafter. In addition to the point In addition to deploying capital to support long-term growth opportunities, we also plan to return capital to shareholders through a new $100 million share repurchase program, reflecting our confidence in the company's long-term growth and commitment to enhancing shareholder value. I'm very pleased with how we are executing on our strategic initiatives. 2025 continues to be a banner year for DynaVax, and we are excited about how we are setting up 2026 and beyond to drive long-term shareholder value through the strength of our base business, and multiple opportunities in our pipeline. Now I'd like to turn the call over to Don.