Vaxcyte, Inc.

¶¶ . . . . . ¶¶ Good afternoon.

My name is Chloe, and I will be your conference operator for the VACC site fourth quarter and full year 2025 financial results conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer period. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star two. Today's call is being recorded. I will now turn the call over to Andrew Guggenheim, President and Chief Financial Officer of VACCITE. Please go ahead, sir.

Thank you, operator. Good afternoon, everyone, and thanks for joining us today as we review our 2025 results and provide a business update. I am joined by our Chief Executive Officer, Grant Pickering, and our Executive Vice President and Chief Operating Officer, Jim Wassel. Earlier today, we issued a news release announcing our results. Copies of this and our other news releases, latest corporate presentation, and SEC filings can be found in the Investors and Media section of our website. Before we begin, I'd like to remind you that during this call, we'll be making certain forward-looking statements about Backsite which are subject to various risks, uncertainties, and other factors that could cause actual results to differ materially from those referred to in any forward-looking statements. For discussion of the risks and uncertainties associated with these statements, please see our press release issued today, as well as our most recent filings with the SEC, including the risk factors set forth in our Form 10-K for the year ended December 31st, 2025, and any subsequent reports filed with the SEC. With that, I'll turn the call over to Grant Pickering. Grant? Thanks, Andrew. As we close out 2025 and look forward to multiple clinical readouts beginning later this year, I'm proud of the progress we made across the company, particularly within our pneumococcal conjugate vaccine or PCV franchise. Despite decades of vaccination efforts, pneumococcal disease continues to drive substantial morbidity and mortality worldwide, particularly among young children and older adults. While current vaccines have made a meaningful impact, gaps in serotype coverage persist and the public health need for broader spectrum protection remains clear. Consistent with that need, we are seeing accelerating growth in the adult PCV market driven by expanded age group recommendations in the United States and increasing international adoption of adult PCV vaccination. Continued momentum in the PCV class has reinforced the size of the opportunity and demand for a PCV that increases disease coverage by protecting against both historically and currently circulating serotypes while maintaining robust immune responses. Taken together, this underscores our opportunity to improve public health as we prepare to enter an increasingly attractive commercial market. The unprecedented results from our Phase II study in adults demonstrated that Vax31 may offer substantial improvement over existing products and achieve our objective to significantly expand disease coverage while maintaining high immunogenicity responses. And with the Opus Phase III program underway, we believe that we are uniquely positioned to set a new standard by which future adult pneumococcal vaccines will be measured. In December, we initiated Opus 1, our pivotal non-inferiority study, and expect to announce top-line safety, tolerability, and immunogenicity data in the fourth quarter of this year. In January, we initiated Opus 2, a Phase 3 trial evaluating Vax31 when administered concomitantly with a licensed seasonal influenza vaccine, reflecting real-world vaccination practice. And earlier this month, we announced the initiation of our Opus 3 trial to evaluate the safety, tolerability, and immunogenicity of Vax31 in adults who previously received lower-valency pneumococcal vaccines. For this population, Vax31 could represent a substantial incremental benefit and could be well-positioned to obtain a catch-up recommendation. We look forward to the readouts for both Opus 2 and 3 in the first half of 2027. In infants, we reported the final data from the Vax24 Phase 2 dose-finding study in November. These data were consistent with the previously reported positive interim results and provided important encouraging insights into immune responses, concomitant administration with other vaccines, and dose responsiveness. Based on these learnings, we modified the ongoing Vax31 infant phase two study to include an optimized dose arm in order to evaluate multiple higher doses than those explored in the Vax24 infant study. Enrollment for this study is now complete and we expect to announce top-line safety, tolerability, and immunogenicity data for both the primary three-dose immunization series and booster dose either sequentially or together by the end of the first half of 2027. In parallel, we continue to make strides to fortify our manufacturing capabilities, commercial readiness, and financial foundations. On the manufacturing front, I'm pleased to report that we have now completed the construction of the dedicated large-scale manufacturing facility on time and on budget that has been designed to support global commercial demand for our PCB candidates throughout the developed world. In addition, the build-out of a high-volume, custom-filled finished production line in North Carolina is underway as part of a long-term investment of up to $1 billion in U.S. manufacturing and services. In advance commercial readiness, we began to scale the organization, including the appointment of our first chief commercial officer, Mike Millett, and the initiation of launch planning activities in earnest. These actions reflect our conviction in the long-term potential of our PCB franchise and our focus on a highly successful commercial launch. Turning to our balance sheet, we strengthened our already robust financial position with the successful completion of a public equity offering in February. We believe we are well-positioned to advance our programs through multiple upcoming data readouts while continuing to invest in the capabilities needed to prepare for commercialization. Overall, 2025 is about focused execution on our clinical programs and establishing the infrastructure clinically, operationally, and organizationally to support what we believe will be a defining period ahead. None of this progress would have been possible without the expertise and dedication of our teams across the organization, and I want to thank them for their commitment. With that, I'll turn the call over to Jim to walk through our clinical programs in more detail, including the Opus Phase III program, the infant program, and an important update on VaxA1, our Group A strep candidate.