Vaxcyte (PCVX) investor relations material

Technology and pipeline overview

• Proprietary cell-free protein synthesis platform enables precise conjugation and broader-spectrum vaccines with improved immunogenicity compared to existing options.

• Lead program, Vax 31, has shown compelling results in adults and is in phase 2 for infants, with phase 3 initiation planned soon.

• The pneumococcal conjugate vaccine (PCV) franchise is the current focus, with plans to expand technology to other vaccines.

Clinical development and regulatory progress

• Phase 3 pivotal study for Vax 31 in adults to begin in Q4, with additional studies starting before year-end and into next year.

• Data from phase 3 studies expected in 2026 and 2027, with a BLA filing targeted for late 2027 and potential approval in 2028.

• FDA interactions have been constructive, with no new requirements for placebo or efficacy studies and consistent guidance across administrations.

• Phase 3 program will include non-inferiority, safety, and label-expanding studies, with sequencing of data readouts to be clarified after enrollment begins.

Manufacturing and CMC strategy

• FDA has approved initiation of phase 3 based on robust CMC data, confirming the process for commercial-scale production.

• Manufacturing investment is seen as critical for long-term success in the $8B pneumococcal vaccine market.

• While the platform is novel, most manufacturing and assay requirements align with established standards, with only minor adjustments.