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Sep 30, 2023
Vaxcyte Q3 2023 Earnings Report
Vaxcyte reported Q3 2023 financial results and provided a business update.
Key Takeaways
Vaxcyte reported $1.4342 billion in cash, cash equivalents and investments as of September 30, 2023. The company's net loss was $92.7 million, compared to $57.9 million for the same period in 2022. VAX-24 adult Phase 3 program is expected to have topline data in 2025. VAX-31 Adult IND Application received FDA Clearance; Phase 1/2 Study Initiation Expected This Quarter and Topline Data Expected in the Second Half of 2024.
Completed Successful End-of-Phase 2 Meeting with FDA for VAX-24.
Received FDA Clearance of VAX-31 Adult IND Application; Phase 1/2 Study Initiation Expected This Quarter and Topline Data Expected in the Second Half of 2024.
Advanced Ongoing VAX-24 Infant Phase 2 Study; Topline Data from Primary Immunization Series Expected by 2025.
Expanded Collaboration with Lonza for Global Commercial Manufacturing of Broad-Spectrum Pneumococcal Conjugate Vaccine Candidates, VAX-24 and VAX-31, in Adult and Pediatric Populations.
Forward Guidance
Vaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones.
Positive Outlook
- Meetings with the FDA regarding the Company’s CMC strategy to finalize the Company’s Phase 3 program and BLA requirements expected to occur through the first quarter of 2024.
- 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.
- Initiation of the Phase 1/2 study in the fourth quarter of 2023.
- Topline safety, tolerability and immunogenicity data from the Phase 1/2 study in adults in second half of 2024.
Historical Earnings Impact
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