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Jun 30, 2022
Vaxcyte Q2 2022 Earnings Report
Vaxcyte reported financial results for the second quarter of 2022 and provided a business update.
Key Takeaways
Vaxcyte reported cash, cash equivalents and investments of $361.4 million as of June 30, 2022. The company's net loss for the quarter was $48.5 million. Enrollment was completed for the Phase 2 portion of the VAX-24 clinical proof-of-concept study in adults.
Completed Enrollment of Phase 2 Portion of VAX-24 Phase 1/2 Clinical Proof-of-Concept Study in Adults.
First Participants Dosed in Separate VAX-24 Phase 2 Clinical Study in Adults 65 Years and Older, with Topline Data Expected in the First Half of 2023.
Received FDA Fast Track Designation for VAX-24 in Adults.
Completed Successful Pre-IND Meeting with FDA Regarding VAX-24 Pediatric Program, Supporting Path to Proceed Directly into Infants.
Vaxcyte
Vaxcyte
Forward Guidance
Vaxcyte anticipates several key milestones for its vaccine programs.
Positive Outlook
- Topline safety and tolerability results from the Phase 1 portion of the VAX-24 study and safety, tolerability and immunogenicity results from the Phase 2 portion of the study are expected in October or November 2022.
- Topline safety, tolerability and immunogenicity results from the Phase 2 study in adults 65 years of age and older are expected in the first half of 2023.
- Vaxcyte anticipates submitting its first VAX-24 pediatric IND application to the FDA in the first half of 2023, subject to satisfactory topline results from the ongoing VAX-24 Phase 1/2 clinical proof-of-concept study in adults 18 to 64 years of age.
- Guidance for the anticipated submission of its IND application in adults to the FDA for VAX-XP is expected following the announcement of the topline results from the ongoing VAX-24 Phase 1/2 study in adults aged 18 to 64.
- Guidance for its anticipated IND application submission to the FDA for VAX-A1 is expected in the second half of 2022.