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Mar 31, 2023
Vaxcyte Q1 2023 Earnings Report
Vaxcyte reported financial results for the first quarter ended March 31, 2023 and provided a business update.
Key Takeaways
Vaxcyte reported positive data from the Phase 2 study in adults aged 65 and older, confirming the clinical potential of VAX-24 and validating the carrier-sparing, cell-free platform. The company's balance sheet was further strengthened by a recent follow-on equity offering, allowing for expansion of manufacturing capabilities and advancement of the PCV franchise.
Reported positive data from Phase 2 study of VAX-24 in adults aged 65 and older, demonstrating robust immune responses across all 24 serotypes.
Completed a successful $575 million follow-on financing, strengthening the balance sheet.
Dosed first participants in infant Phase 2 study evaluating VAX-24 for the prevention of Invasive Pneumococcal Disease (IPD).
VAX-31 progressing with Adult Investigational New Drug (IND) application submission and subsequent clearance announcement expected in second half 2023 and Topline Phase 1/2 Data in 2024.
Vaxcyte
Vaxcyte
Forward Guidance
Vaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones.
Positive Outlook
- End-of-Phase 2 meeting with the FDA in the second half of 2023 to inform the conduct of the adult Phase 3 program.
- Topline safety, tolerability and immunogenicity data from the Phase 3 pivotal non-inferiority study in adults in 2025.
- Topline safety, tolerability and immunogenicity data from the primary three-dose immunization series of the infant Phase 2 study by 2025, followed by topline data from the booster dose approximately nine months later.
- Submission of the adult IND application to the FDA and announcement of subsequent FDA clearance in the second half of 2023.
- Topline safety, tolerability and immunogenicity data from the Phase 1/2 study in adults in 2024.