Vaxcyte, Inc.

Good afternoon, everyone. My name is Beau, and I will be your conference operator today. At this time, I would like to welcome everyone to the Backsite Fourth Quarter and Full Year 2023 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, simply press star two. And just a reminder, today's call is being recorded. Now at this time, I'll turn things over to Mr. Andrew Guggenheim, President and Chief Financial Officer of Backsite. Please go ahead, sir. Thank you, Operator, and good afternoon, everyone. I'd like to welcome you to Backsite's earnings conference call to discuss our 2023 results and to provide a business update. I'm joined today by our Chief Executive Officer, Grant Pickering, and our Executive Vice President and Chief Operating Officer, Jim Wassel. Earlier this afternoon, we issued a news release announcing our results. Copies of this and our other news releases, with its 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, will be making certain forward-looking statements about VAC sites 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, 2023, and any subsequent reports filed with the SEC.

With that, I'll turn the call over to Grant Pickering. Grant? Grant Pickering Thanks, Andrew. And all of you on the call and webcast, thank you for joining us today. 2023 was another remarkable year for Backsite. officially marking our 10th year of thoughtful and methodical research and development by the entire Backsite team and our partners. We're driven by our mission to prevent or treat infections caused by bacterial diseases, including invasive pneumococcal disease, or IPV. This past year, we continue to make significant strides in advancing our potentially best-in-class pneumococcal conjugate vaccines, or PCVs, Vax24, our lead 24-valent candidate, and Vax31, our next-generation 31-valent candidate. And we remain focused on providing the broadest spectrum of coverage against IPV for both adults and children. Last year was highlighted by the successful completion of our VAX24 Adult Phase II program. Following our stellar initial proof-of-concept data in late 2022 in adults aged 50 to 64, we reported data in April 2023 from a separate Phase II study in adults 65 and older that not only confirmed the prior proof-of-concept study results, but showed even greater immune responses compared to PREVNR20 on a relative basis. These data further validate the potential of our cell-free platform and carrier-sparing approach to deliver broader-spectrum PCBs. The findings from our Adult Phase II program support a potential investment class profile for VEX24 and demonstrate how our novel cell-free technology platform has the capability to overcome the limitations of other conventional approaches. These results and the foundation we have carefully created have us well positioned to advance our PCD franchise to potentially disrupt what has consistently been a crucial vaccine class societally and financially. Following the Vax24 Adult Phase II program completion, we made important progress with regulators. This included a successful end of Phase II meeting with the FDA regarding the clinical design of the Vax24 Phase III program, as well as encouraging feedback on CMC-related matters as we plan for future potential VLA submissions. In addition to the positive developments for Vax24, we were pleased to initiate the adult clinical program for Vax31. With this important step, Vax31 is now the broadest spectrum PCD in the clinic. Following the FDA's acceptance of the adult IND, we initiated the Phase I portion of a Phase I-II study in adults 50 and older in November. The strong momentum of this study continued into 2024 as we announced the start of the Phase II portion in early January and completion of enrollment less than a month later. I am incredibly proud of our many achievements, particularly across clinical, regulatory, and manufacturing for our PCV programs, and we now look ahead to several important milestones. For the adult indication, our VAX24 program is phase three ready, and we are in the final stages of manufacturing the product needed for several of the potential phase three studies, including the pivotal non-inferiority study. In advance of the potential initiation of this VAX24 study in the second half of this year, we expect to announce the top line safety, tolerability, and immunogenicity data from our VAX31 adult phase one, two study in the third quarter. this timing and the overlapping timeline for the completion of the VAX 24 and VAX 31 adult phase three studies provide us the opportunity to make a strategic decision regarding which adult program we will move into phase three following the VAX 31 data readout. If we advance VAX 24, we intend to initiate the pivotal non-inferiority study in the second half of this year. and the balance of the Phase III studies, which are shorter in duration than the non-inferiority study, in 2025 and 2026. If we advance to Act 31, we expect to initiate the full complement of the Phase III studies in 2025 and 2026. Regardless of which program we move forward, we expect to initiate the final Phase III studies in 2026. and subject to the results of these studies, submit a BLA shortly following the completion of the last study. Vax24 remains a potential best-in-class candidate, covering more serotypes than any pneumococcal vaccine on market or in U.S. clinics today. And Vax31 has the potential to further increase coverage to approximately 95% of IPV circulating in the U.S. adult population. Beyond expanded disease protection, Vax31 is designed to also maintain coverage of previously circulating strains that are currently contained via ongoing vaccination. This is critical since previously controlled strains have rebounded in prior instances where vaccine coverage was withdrawn. This puts us in a unique position relative to other sponsors who are applying the conventional PCV approach and are forced to make sacrifices in an attempt to cover newly circulating strains. We estimate that the adult pneumococcal vaccine market today is approximately $2 billion of the total $8 billion annual global market and is positioned to be the fastest growing segment. Growth in the U.S. market is expected to accelerate due to the potential shift in universal adult vaccination from age 65 down to 50, which would both expand the market and open up the adult regimen to a prime blue schedule, nearing the infant market. Outside the U.S., we expect to see other countries begin to routinely recommend adult vaccination, as evidenced by the recent recommendation in Germany to vaccinate adults 60 and older. While the adult market is expected to grow significantly, the infant segment continues to represent the largest portion of the global pneumococcal vaccine market at an estimated $6 billion in sales annually. We believe Vax24 has a potential best-in-class profile for this vital population, and we are thrilled to be nearing the completion of enrollment of the second and final stage of our Vax24 Infant Phase 2 study. Based on our progress, we expect the top line data from the primary immunization series by the end of the first quarter of 2025, with the top line booster data to follow by the end of that year. In contrast to the adult program, the Vax24 Infant Clinical Program is substantially ahead of the Vax31 Infant Program, and we intend to advance both of our PCV candidates in this population. We expect to provide guidance on the potential timing for a VAX31 infant IMD following the readout of the VAX31 Phase I-II Adult Study later this year. Bringing the broadest PCBs to both infants and adults represents an opportunity to significantly reduce invasive disease across the entire population is what drives our efforts every day. Given the magnitude of the opportunity of our PCB franchise, we continue to invest in further solidifying our manufacturing foundation to enable robust, large-scale manufacturing. These investments are intended to support the potential global commercialization of our PCBs for both the adult and infant populations. Our expanded relationship with Lonza and our decision to exercise our option with Futuro Biopharma both of which we announced late last year, are reflective of these efforts. In addition to our PCV franchise, we continue to advance our earlier stage vaccine candidates, including VaxA1 to prevent group A strep, VaxPG to treat periodontitis, and VaxGI to prevent dysentery and shigellosis. VaxA1 and VaxGI, as well as our PCV programs, target diseases that are significant contributors to antimicrobial resistance, or AMR. AMR poses a serious global health threat, and if no action is taken, drug-resistant diseases are expected by the WHO to be a leading cause of death by 2050. While AMR is a complex crisis that no single solution will fully address, vaccines represent an important part of the solution. We are proud to develop vaccines to help fight diseases that have become increasingly resistant to treatment with antibiotics, and we look forward to sharing more updates on our earlier stage pipeline over the course of the year. From a financial perspective, we substantially strengthened our balance sheet, raising approximately $545 million in net proceeds in a follow-on financing last April, and then added another $816 million earlier this month. Pro forma, after this most recent financing, we had over $2 billion in cash and investments as of year-end. This financial strength provides us the capital to fund the company through several important milestones over the next few years, which Andrew will highlight later. I'll now turn it over to Jim, who will provide more details on our PCV programs and strategy. Jim?