Vaxcyte Reports Third Quarter 2025 Financial Results and Provides Business Update Including Final Data from Positive VAX-24 Infant Phase 2 Dose-Finding Study

Core Insights - Vaxcyte, Inc. announced positive final data from the VAX-24 infant Phase 2 dose-finding study, confirming previously reported interim results and supporting the evaluation of higher doses in the ongoing VAX-31 infant Phase 2 study [1][4][10] - The company plans to initiate the VAX-31 adult pivotal, non-inferiority study in December 2025, with topline data expected in 2026 [1][2] - Vaxcyte is establishing fill-finish manufacturing in North Carolina, representing a long-term commitment of up to $1 billion, aligning with U.S. biomanufacturing initiatives [1][12] - The company appointed Mike Mullette as Chief Commercial Officer to lead commercialization efforts for VAX-31 as it advances to Phase 3 [1][14] - Vaxcyte reported a cash position of approximately $2.7 billion as of September 30, 2025, expected to fund operations into mid-2028 [1][2] PCV Program Updates - The final data from the VAX-24 study showed robust, dose-dependent immune responses with minimal carrier suppression, validating the rationale for higher doses in the VAX-31 study [2][4][6] - The VAX-31 infant Phase 2 study has progressed to its third and final stage, aiming to expand coverage against invasive pneumococcal disease (IPD) in children under five years of age [10][12] - VAX-31 is designed to increase protection against IPD from approximately 69% to 92% by adding 11 incremental serotypes compared to the current standard, PCV20 [10] Financial Highlights - For Q3 2025, Vaxcyte reported a net loss of $212.8 million, compared to a net loss of $103.1 million in Q3 2024 [23] - Research and development expenses for Q3 2025 were $209.9 million, up from $116.9 million in the same period in 2024, primarily due to increased development activities [17][23] - General and administrative expenses rose to $32.4 million in Q3 2025 from $23.0 million in Q3 2024, reflecting higher personnel costs [17][23] Manufacturing and Leadership - The company is expanding its fill-finish manufacturing capacity in North Carolina through a partnership with Thermo Fisher Scientific, enhancing its supply chain and commercial readiness [12] - Mike Mullette's appointment as Chief Commercial Officer is aimed at strengthening the company's commercialization strategy for its pneumococcal conjugate vaccine programs [14] Upcoming Milestones - Vaxcyte anticipates initiating the VAX-31 Phase 3 pivotal study in December 2025 and plans to announce topline safety and immunogenicity data in 2026 [15][18]