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Vaxcyte (PCVX) investor relations material

Vaxcyte Cantor Global Healthcare Conference 2025 summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Cantor Global Healthcare Conference 2025 summary3 Sep, 2025

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.

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Frequently asked questions

Vaxcyte Inc. is a clinical-stage biotechnology company focused on the development of novel protein vaccines aimed at preventing or treating bacterial infectious diseases. Its leading vaccine candidate, VAX-24, is a 24-valent investigational pneumococcal conjugate vaccine designed to prevent invasive pneumococcal disease. In addition to VAX-24, Vaxcyte is working on several other vaccine candidates, including VAX-31, to address emerging strains and antibiotic resistance; VAX-A1, targeting Group A Streptococcus; VAX-PG, aimed at a keystone pathogen responsible for periodontitis; and VAX-GI, to prevent Shigella. The company is headquartered in San Carlos, California and its shares are listed on the NASDAQ stock exchange.

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