Summary of Vaxcyte Conference Call Company Overview - **Company**: Vaxcyte - **Event**: Guggenheim's second annual Healthcare Innovations Conference - **Key Speakers**: Andrew Guggenheim (President and CFO), Jim Wassil (EVP and COO) Industry Context - **Industry**: Pneumococcal Vaccine Market - **Market Size**: Current market valued at approximately $8 billion, projected to grow to $12-$14 billion over the next decade [8][11] - **Adult Market**: Represents about $2 billion of the total pneumococcal vaccine market [2] Key Developments and Progress - **31-Valent Adult Program**: - Phase three study expected to start in December 2023, with top-line results anticipated in 2026 [3][14] - The program aims to cover about 95% of strains, providing a significant increase over existing vaccines [18] - **24-Valent Infant Program**: - Recent data showed robust immune responses and strong dose response profiles [3][24] - The study is ongoing, with data expected in one or two installments by the end of 2026 or early 2027 [4][34] - **Commercial Readiness**: - Appointment of Mike Millett as Chief Commercial Officer, bringing extensive vaccine experience [5] - Completion of a dedicated manufacturing facility in partnership with Lonza expected early next year [5][6] Market Dynamics - **Market Evolution**: - Shift from an infant-based market to a more balanced adult and infant market due to lower age recommendations for vaccination [9][11] - Increased eligibility in the U.S. with recommendations now including individuals aged 50 and above, expanding the potential market significantly [9] - **Competitive Landscape**: - Vaxcyte is positioned favorably against competitors, with a lead in the development timeline for its 31-valent vaccine [45] - Competitors have faced delays, potentially widening Vaxcyte's lead [45] Financial Position - **Balance Sheet**: - Vaxcyte reported $2.7 billion in cash and equivalents as of September, providing strong financial support for clinical advancements and commercial readiness [6] Additional Insights - **Regulatory Environment**: - The FDA has not requested a placebo-controlled study for the upcoming phase three trial, which is expected to facilitate enrollment [15][20] - **Immunogenicity Data**: - The company is optimistic about the immune response based on previous phase two data, with expectations to replicate results in phase three [19][41] - **Serotype Coverage**: - The vaccine aims to cover additional serotypes not included in existing vaccines, enhancing its market potential [30][32] Conclusion - Vaxcyte is on track for significant advancements in the pneumococcal vaccine market, with promising clinical data and a strong financial position. The company is preparing for pivotal studies that could lead to market approval and is well-positioned against competitors in a growing market.

VAX-31 Phase 1/2 Study Results Overview - VAX-31 demonstrated a safety profile similar to Prevnar 20® (PCV20) at all doses studied[14] - VAX-31 induced robust OPA immune responses for all 31 serotypes (STs) at all doses studied, with all three doses advanceable to Phase 3[14] - The VAX-31 data validate the potential of Vaxcyte's carrier-sparing platform to deliver the broadest-spectrum PCVs[15] Immunogenicity Data - High and Middle doses of VAX-31 met or exceeded OPA regulatory immunogenicity criteria for all 31 STs, while the Low dose met the criteria for 29 of 31 STs[17] - For the 20 STs common with PCV20, the High dose had 18 with GMR greater than 10, the Middle dose had 13 with GMR greater than 10, and the Low dose had 8 with GMR greater than 10[17] - For the 11 additional STs unique to VAX-31, all 11 met the superiority criteria at all doses[17] Clinical Development Plan - Vaxcyte plans to initiate a Phase 3 pivotal, non-inferiority study for VAX-31 in adults by mid-2025, with topline results expected in 2026[18] - Vaxcyte plans to initiate a VAX-31 infant Phase 2 study in 1Q:2025 following IND submission and clearance[18] Market Opportunity - The pneumococcal vaccine market is expected to reach approximately $13 billion by 2027[105] - VAX-31 is designed to increase coverage to more than 95% of IPD circulating in U S adults[104]