Vaxcyte Reports First Quarter 2025 Financial Results and Provides Business Update

Core Insights - Vaxcyte, Inc. reported positive topline safety, tolerability, and immunogenicity data from the Phase 2 dose-finding study of VAX-24 in healthy infants, with further data expected by the end of 2025 [1][3] - The company has initiated the second and final stage of the VAX-31 infant Phase 2 dose-finding study, with topline data anticipated in mid-2026 [1][5] - Vaxcyte plans to initiate a Phase 3 pivotal, non-inferiority study for VAX-31 in adults by mid-2025, with topline data expected in 2026 [1][8] - The company announced VAX-XL, a third-generation pneumococcal conjugate vaccine candidate aimed at expanding coverage [1][5] - As of March 31, 2025, Vaxcyte had approximately $3.0 billion in cash, cash equivalents, and investments [1][11] PCV Franchise Developments - VAX-24 demonstrated a well-tolerated safety profile similar to Prevnar 20® across all doses studied, with substantial immunoglobulin G (IgG) and opsonophagocytic assay (OPA) immune responses observed [3][4] - The mid-dose of VAX-24 met the target Phase 2 non-inferiority criteria for seroconversion rates and IgG Geometric Mean Ratio (GMR) point estimates [3][7] - VAX-31 has progressed to the second stage of its Phase 2 study, evaluating safety and immunogenicity compared to PCV20 in infants [5][7] Financial Performance - For Q1 2025, Vaxcyte reported a net loss of $140.7 million, compared to a net loss of $95.0 million in Q1 2024 [11][21] - Research and development expenses increased to $148.1 million in Q1 2025 from $94.6 million in Q1 2024, primarily due to development activities for PCV programs [11][21] - General and administrative expenses rose to $32.7 million in Q1 2025 from $19.9 million in Q1 2024, attributed to higher personnel costs [11][21] Key Milestones and Future Plans - The company plans to announce the balance of the VAX-24 Phase 2 study data, including final safety and full post-dose data, by the end of 2025 [6][9] - Vaxcyte anticipates initiating a Phase 3 program with an optimized dose formulation of VAX-24 or VAX-31, pending the VAX-31 topline Phase 2 study results [5][8] - Upcoming investor conferences will feature management participation, providing opportunities for engagement with stakeholders [10][13]