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Vaxcyte Completes Enrollment of OPUS-1 and OPUS-2 Phase 3 Trials Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults

OPUS-1 Phase 3 Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines (PCVs) Through Head-to-Head Safety, Tolerability and Immunogenicity Comparisons of VAX-31 with Capvaxive® (PCV21) and Prevnar 20® (PCV20), the Current Standard-of-Care PCVs

Positive VAX-31 Phase 1/2 Adult Data Published in The Lancet Infectious Diseases Highlight Best-in-Class Potential of Vaxcyte's 31-Valent Pneumococcal Conjugate Vaccine (PCV) Candidate

Based on the Strength of Unprecedented Results from the Positive Phase 1/2 Study in Adults Aged 50 and Older, Vaxcyte Advanced VAX-31 High Dose into Comprehensive Phase 3 Adult Program; Topline Data from the OPUS-1 Pivotal Noninferiority Trial Expected in the Fourth Quarter of 2026

Vaxcyte Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Comprehensive VAX-31 Adult Phase 3 Clinical Program, Finalized in Consultation and Alignment with FDA, Advances with Three Phase 3 Studies Underway to Support Planned BLA Submission Topline Safety, Tolerability and Immunogenicity Data from OPUS-1 Expected in Fourth Quarter of 2026; OPUS-2 and OPUS-3 Results Expected in First Half of 2027 Enrollment Completed in VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series and Booster Dose Expected Either Sequentially or Together by End of First Half of 2027 Company Advancing Early-Stage Pipeline, Expects to Initiate Phase 1 Adult Clinical Study for VAX-A1, a Vaccine Candidate to Prevent Group A Strep, in 2026 Company Advances Global and U.S. Manufacturing Capabilities to Support Commercialization of Pneumococcal Conjugate Vaccines with Completion of Dedicated Lonza Facility and Initiation of North Carolina Fill-Finish Line Buildout Approximately $2.4 Billion in Cash, Cash Equivalents and Investments as of December 31, 2025 ; Excludes Approximately $600.2 Million in Net Proceeds from February 2026 Equity Offering Company to Host Webcast/Conference Call Today at 4:30 p.m. ET / 1:30 p.m.

Vaxcyte Doses First Participants in OPUS-3 Phase 3 Trial Evaluating VAX-31 in Adults Previously Vaccinated with Lower-Valency Pneumococcal Vaccines

Company Expects to Report Topline Data from OPUS-3 Trial and OPUS-2 Phase 3 Trial Evaluating Concomitant Administration of VAX-31 and a Seasonal Influenza Vaccine in First Half of 2027