Vaxcyte, Inc.

Good afternoon. My name is Lisa, and I will be your conference operator today. At this time, I would like to welcome everyone to the FACT site fourth quarter and full year 2022 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 session. If you would like to ask a question during this time, simply press star one one. on your telephone keypad. If you would like to withdraw your question, please press star 11 again. I now would like to turn the call over to Andrew Guggenheim, President and Chief Financial Officer of AXSET. Please go ahead, sir.

Thank you, Operator, and good afternoon, everyone. I'd like to welcome you to VACCITE's earnings conference call to discuss our 2022 results and to provide a business update. I am joined today by our Chief Executive Officer, Grant Pickering, our EVP and Chief Operating Officer, Jim Wassel, and our VP of Research, Jeff Harriman. Earlier this afternoon, 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 statement. 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 31, 2022, and any subsequent reports filed with the SEC. With that, I'll turn the call over to Grant Pickering. Grant?

Thank you, Andrew. And to all of you on the call and webcast, thanks for joining us today. 2022 is a landmark year for VaxSight. We reported positive and unprecedented proof-of-concept, top-line clinical data for Vax24, our lead pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease in adults. These remarkable data validate our PCB franchise and our carrier sparing approach for broad-spectrum PCBs, as well as our cell-free platform. They also represent the culmination of nearly a decade of thoughtful and methodical research and development by the entire VACS site team and their partners. The findings of the large phase two study in adults 18 to 64 years of age indicate a potential best-in-class profile for VACS24 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 PCB franchise to potentially disrupt what has consistently been a crucial vaccine class societally and financially. I'm incredibly proud of the progress this past year, and I'm optimistic about our ability to execute and further scale our business in 2023 and beyond. As we look ahead, we remain focused on advancing both of our PCB franchise programs, Vax24 and Vax31, which we previously referred to as VaxXP with several upcoming milestones. BACS24, our lead PCV candidate, was recently granted breakthrough therapy designation for adults, adding to its fast-track designation, and we remain on track to deliver top-line safety, tolerability, and immunogenicity results in subjects 65 and older in the second quarter of this year. As we've discussed with many of you, for this pending readout, our focus from an immunogenicity perspective is almost exclusively on the and their comparability to the prior results in our much larger phase two study in younger adults. Given the smaller size of this older adult trial at 50 subjects per cohort, these point estimate GMRs are the most important focal point and not the lower bounds of the confidence intervals. This study was not powered to meet the regulatory non-inferiority standard, and as a result, these confidence intervals will be substantially wider. The combined data from both adult Phase II studies will enable us to perform the statistical powering necessary to tee up our pivotal Phase III non-inferiority study for Vax24 in adults. These data, along with the full six-month safety data from both studies, will facilitate our end-of-Phase II meeting with FDA, which we expect to hold in the second half of this year. To put the U.S. adult PCB market opportunity into context, today it is approximately $2 billion of the $7 billion total annual global market and is expected to be the fastest-growing segment of the market going forward. Key growth drivers include an increase in adult vaccination rates outside the U.S., and in the U.S., the potential shift to universal adult vaccination which itself would expand the market and open up the adult regimen to a prime blue schedule, as is the case in the infant market. The infant cohort represents the largest portion of the global pneumococcal vaccine market, with approximately $5 billion in annual sales. And we are thrilled to be launching our first clinical program in infants in the second quarter of this year. This follows FDA clearance of our IND application, which we announced last week. Bringing the broadest PCV to both infants and adults represents an opportunity to significantly reduce invasive disease across the entire population. To maintain a long-term leadership position in this market and to address the serotype replacement phenomenon that we would expect based on a widespread use of the 24-valent PCV, we continue to invest in our 31-valent FACTS31 program. Similar to Vax24, we believe our unique carrier-sparing PCD approach gives us the opportunity to expand the spectrum of coverage to address additional pathogenic stereotypes without compromising the ability to continue to vaccinate against previously circulating strains. This is critical since previously controlled strains have rebounded in prior instances where vaccine coverage was withdrawn. This puts VaxSight in a different position than other sponsors who are applying the conventional PCV approach and are forced to make sacrifices in an attempt to cover newly circulating strains. We have continued to make significant investments in the advancement of AX31 and expect to submit the adult IMD for this program in the second half of this year and deliver top-line data next year. Beyond our PCV franchise, we continue to progress and bolster our early-stage pipeline of novel vaccines, including VaxA1. conjugate vaccine candidate designed to prevent infections in both adults and children caused by group A strep bacteria, and VaxPG, which is designed to treat periodontal disease. We are also introducing a new program called VaxGI, a vaccine designed to prevent Shigella, a dangerous bacterial infection with significant fatality rates among infants in low- and middle-income settings. Jeff will provide additional details on our earlier stage programs later on today's call. Given the magnitude of the opportunity for our PCB franchise, we continue to invest to further solidify our manufacturing foundation. Our strategic relationship with Lonza remains strong, and we believe we are well positioned to support a potential AdultVax24 launch in the U.S. market out of existing Lonza facilities. Plans to ensure an expanding commercial manufacturing footprint to support the infant indication, and ex-U.S. markets are underway. Additionally, we further fortified our extract supply chain via our recent expanded agreement with Sutra BioPharma. From a financial perspective, we are in a strong position, with over $950 million on the balance sheet as of December 31st, aided by two successful follow-on financings last year, totaling $805 million in gross proceeds. This financial strength provides us the capital to fund through several important incremental milestones, which Andrew will highlight later. I'll now turn it over to Jim, who will provide more details on our PCV programs. Jim.