Vaxcyte, Inc.

Good afternoon. My name is Josh, and I will be your conference operator today. At this time, I would like to welcome everyone to the VAC site fourth quarter and full year 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, followed by the number one on your telephone keypad. If you would like to withdraw your question, press the pound key. Thank you. I will now turn the call over to Andrew Guggenheim, President and Chief Financial Officer of VACCITE. 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 2021 results and to provide a business update. I'm joined today by our Chief Executive Officer, Grant Pickering, our Chief Operating Officer, Jim Wassel, and our VP of Research, Jeff Fairman. 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 in 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 and uncertainties. These include statements related to the benefits of our vaccine candidates, the process and timing of anticipated future development of our vaccine candidates, including the timing and availability of top-line data from the Vax24 Phase 1-2 Clinical Proof of Concept Study, the demand for our vaccine candidates, our expected uses and sufficiency of cash and other funding to support our development programs and other operating expenses, and other statements that are not historical fact. Any forward-looking statements are based on facts and assumptions as of today, and we undertake no obligation to update them. Our actual results may differ materially from these statements. Investors should read the risk factors set forth in BackSite's Form 10-K for the year ended December 31, 2021, and any subsequent reports filed with the SEC. With that, I'll turn the call over to Grant Beckering. Grant?

Thanks, Andrew. And to all of you on the call and webcast, thanks for joining us today. The past year was an extremely important one for VaxSight. We made significant advancements across our business, which remains focused on eradicating bacterial infections such as invasive pneumococcal disease, group A strep, and periodontitis. We advanced our pipeline, demonstrated the potential of our novel vaccine platform, and onboarded the right expertise to help us transition into the clinic and prepare for manufacturing scale-up and late-stage development. While we all witness the global impact of vaccine innovation on a scale not seen since the 1950s, bacterial infectious diseases have not historically received adequate attention. As a result, the global incidence of pneumococcal disease continues to climb, driven by emerging serotypes not covered by currently available vaccines. Although the available pneumococcal conjugate vaccines, or PCBs for short, are effective, the underlying chemistry appears to have reached its limit in terms of its ability to permit addition of serotypes to broaden protection without diminished overall immune responses, jeopardizing their long-term protection. Our strategy is to overcome such limitations by applying advanced chemistry and modern synthetic techniques, including the Express CF cell-free protein synthesis platform, to produce vaccines that are uniquely capable of breaking down bacteria's complex defense mechanisms while preserving immunogenicity across a broader spectrum of coverage. Our site-specific conjugation technology allows us to engineer broader spectrum PCVs designed to avoid carrier suppression in ways that we anticipate will afford our PCV franchise an opportunity to surpass the coverage of other pneumococcal vaccines. With this competitive advantage, we believe Vax24, our lead 24-valent vaccine candidate, has the opportunity to be a best-in-class PCV in both adults and pediatrics in an already $7 billion global market that is poised to undergo significant further growth. Our recent achievements with Vax24 have paved the way for a surge in momentum in 2022 as we reach key anticipated milestones. Just last week, we announced the dosing of the first participants in the Vax24 Phase 1 portion of our Phase 1-2 clinical study in adults and anticipate announcing the top line results of both the Phase 1 and phase two portions by year end. This study is designed to determine the optimal dose of vax 24 based on safety and immunogenicity and to inform how we power a future pivotal phase three immunogenicity study in adults. The immunogenicity data from the phase two portion of this study should tell us if one or more of the vax 24 doses can meet or exceed the noninferior immune response threshold on a serotype by serotype basis that is required for regulatory approval. If achieved, this milestone has the potential to represent a major inflection point for the company. We remain excited about the adult pneumococcal vaccine market given it represents approximately $2 billion in annual sales and has the opportunity to grow significantly based on a number of key factors. First, We've seen premium pricing justified for broader spectrum PCVs, including both of the recently FDA-approved products, Pfizer's 20-valent PCV, Prevnar 20, or PCV20, and Merck's 15-valent PCV, or PCV15. This validates the value associated with broader disease coverage once again. Second, late last fall, the CDC's Advisory Committee on Immunization Practices, or ACIP, recommended a PCB for certain risk groups ages 19 to 64, which further expands the adult market given approximately 30% of adults aged 50 to 64 fall into one of these identified risk groups. Third, during this same ACIP meeting, there was a strong desire expressed by several committee members to lower the universal adult vaccination recommendation from 65 years of age and up down to 50 years of age and up. This move alone would significantly expand the potential size of the adult market. And lastly, by lowering the age recommendation to 50, we may see the door open to a prime boost PCB regimen in adults, which would further grow this market and provide longer-term protection to the elderly population. This could be enabled if a broader spectrum PCB, such as VAX24, were approved. which would eclipse the coverage of the older polysaccharide-only vaccine, Pneumovax 23, and could lead to its removal from the treatment schedule. So, we believe Vax24 is very well positioned in the current market and will have an opportunity to capitalize on additional growth drivers given its potential spectrum of coverage. Importantly, positive results from the ongoing Phase 1-2 study will put us in a position to trigger additional development activities with our PCV franchise. Upon completing the phase one portion of this study, we plan to expand the VAX24 program into the 65 and up population, and upon positive data from the phase two portion, into the well-established and large pediatric segment. Subject to a pre-IND meeting with the FDA, we would expect to be able to submit a pediatric IND application in the first half of 2023. As part of our PCV franchise strategy, we continue to aggressively invest in VaxXP, our PCV candidate with an expanded breadth of coverage of greater than 30 strains. This parallel investment has put us in a position to provide guidance for the anticipated submission of the adult VaxXP IND application following the announcement of top-line results from the Vax24 Phase 1-2 study. Beyond our PCV programs, we continue to make progress with our other pipeline candidates. VaxA1, our vaccine to prevent group A strep infections, is now in IND-enabling activities. We anticipate providing clear guidance on the expected timing for our VaxA1 IND application submission in the second half of this year. The global need for a vaccine to prevent group A strep is compelling in both children and adults, making this an exciting follow-on opportunity behind our PCV franchise that would allow us to once again target a large and broad population. And finally, VaxPG, our vaccine designed to treat periodontal disease, continues to progress, and we intend to nominate the final candidate by the end of this year. To support these programs, we strengthened our balance sheet by completing a $115 million follow-on offering earlier this quarter. With this incremental capital, we believe we have the resources to fund our operations for at least 12 months past the anticipated announcement of the VAX 24 Phase 1-2 top-line results, which is noted is expected by year-end. I'm incredibly proud of what we have achieved and look forward to what promises to be the most important year in the company's history thus far. I'll now turn it over to Jim Wassil, who will share additional information about Vax24, including the Phase 1-2 clinical study design and our VaxXP and VaxA1 programs.