Business
Vaxcyte Reports First Quarter 2025 Financial Results and Provides Business Update
-- Company Reported Positive Topline Safety, Tolerability and Immunogenicity Data from Phase 2 Dose-Finding Study of VAX-24 in Healthy Infants; Balance of
About this update from Vaxcyte, Inc.
[{"type":"text","content":"-- Company Reported Positive Topline Safety, Tolerability and Immunogenicity Data from Phase 2 Dose-Finding Study of VAX-24 in Healthy Infants; Balance of Data Expected by End of 2025 -- -- Initiated Second and Final Stage of VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Three-Dose Immunization Series Expected in Mid-2026, With Complete Booster Data Up to Nine Months Later -- -- Company Expects to Initiate VAX-31 Adult Phase 3 Pivotal, Non-Inferiority Study by Mid-2025 and Announce Topline Safety, Tolerability and Immunogenicity Data in 2026 -- -- Announced VAX-XL, Third-Generation Pneumococcal Conjugate Vaccine Candidate Designed to Further Expand Spectrum of Coverage -- -- Approximately $3.0 Billion in Cash, Cash Equivalents and Investments as of March 31, 2025 -- SAN CARLOS, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the first quarter ended March 31, 2025, and provided a business update. “We continue to make meaningful progress across our pneumococcal conjugate vaccine (PCV) candidates, with each milestone bringing us closer to potentially delivering the broadest-spectrum PCVs to address the substantial invasive pneumococcal disease burden in both adults and infants,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “For the adult indication, we expect to initiate the VAX-31 adult Phase 3 pivotal, non-inferiority study by the middle of this year with topline data expected next year. For the pediatric indication, we expect to announce the balance of the VAX-24 infant Phase 2 dose-finding study data by the end of 2025 and share topline data from the VAX-31 infant Phase 2 dose-finding study primary immunization series in mid-2026, followed by complete booster data up to nine months later. Pending the VAX-31 infant study readout, we plan to initiate a Phase 3 program with an optimized dose formulation of VAX-24 or VAX-31.” “With a strong balance sheet totaling approximately $3.0 billion in cash, cash equivalents and investments, we are well-positioned to continue advancing our PCV pipeline, which we believe has the potential to redefine t...