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Jun 30, 2023
Vaxcyte Q2 2023 Earnings Report
Vaxcyte reported financial results for the second quarter ended June 30, 2023 and provided a business update.
Key Takeaways
Vaxcyte reported a net loss of $68.3 million for the second quarter of 2023. The company's cash, cash equivalents, and investments totaled $1,440.8 million as of June 30, 2023, including $545.3 million in net proceeds from an April public offering. Vaxcyte is advancing its PCV programs and anticipates key milestones, including regulatory interactions for VAX-24 and IND clearance for VAX-31.
Completed VAX-24 Adult Phase 2 Program with Announcement of Positive Data in Adults 65 and Older and Full Six-Month Safety Data from Adult Phase 1/2 and Phase 2 Studies.
Advanced to Second and Final Stage of Phase 2 Study Evaluating VAX-24 for the Prevention of IPD in Infants and Dosed First New Participants.
Completed Successful $575 Million Follow-On Financing.
Published New VAX-GI Preclinical Data and Received NIH Grants.
Vaxcyte
Vaxcyte
Forward Guidance
Vaxcyte is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones.
Positive Outlook
- Several regulatory interactions to finalize the Company’s Phase 3 clinical program and Biologics License Application submission requirements including:
- An End-of-Phase 2 meeting with the FDA regarding the adult Phase 3 clinical program expected in the fourth quarter of 2023.
- Discussions afforded by the Breakthrough Therapy designation granted by the FDA, including meetings regarding the Company’s CMC strategy 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.
- Clearance of the adult IND application by the FDA in the fourth quarter of 2023 following submission.