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Dec 31, 2022
Vaxcyte Q4 2022 Earnings Report
Vaxcyte reported positive topline data from Phase 1/2 study of VAX-24, cleared VAX-24 infant IND application by the FDA, and raised $805 million in gross proceeds in two follow-on equity offerings.
Key Takeaways
Vaxcyte reported financial results for Q4 2022, highlighting the FDA clearance of VAX-24 infant IND application, progress of VAX-31, and a strong cash position of $957.9 million, including $651.6 million from a public offering.
FDA cleared VAX-24 Infant Investigational New Drug Application.
Topline safety, tolerability, and immunogenicity results from VAX-24 Phase 2 study in adults 65 and older are on track for Q2 2023.
Positive topline results from VAX-24 Phase 1/2 proof-of-concept study in adults aged 18-64 indicate a potential best-in-class profile.
VAX-31 is progressing with adult IND application expected in the second half of 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
- Topline safety, tolerability and immunogenicity data from the Phase 2 study in adults 65 and older in the second quarter of 2023.
- Final results with the six-month safety data from the two Phase 2 adult studies in the first half of 2023.
- Following the receipt of the final safety reports from the two adult Phase 2 studies, an end-of-Phase 2 meeting with the FDA in the second half of 2023 to inform the Phase 3 program.
- Initiation of the infant Phase 2 study in the second quarter of 2023.
- Submission of adult IND application in the second half of 2023.