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Dec 31, 2021
Vaxcyte Q4 2021 Earnings Report
Vaxcyte reported fourth quarter and full year 2021 financial results and provided a business update.
Key Takeaways
Vaxcyte announced its Q4 and full year 2021 financial results, highlighting the completion of VAX-24 drug product manufacturing and the initiation of a Phase 1/2 clinical study for VAX-24. The company's cash, cash equivalents, and investments totaled $273.1 million as of December 31, 2021, excluding net proceeds from a recent public offering.
Completed the manufacture of VAX-24 drug product.
Dosed first participants in VAX-24 Phase 1/2 clinical study.
Advanced and presented preclinical data for VAX-XP program.
Initiated VAX-A1 IND-enabling activities.
Vaxcyte
Vaxcyte
Forward Guidance
Vaxcyte anticipates several key milestones for its vaccine programs, including VAX-24, VAX-XP, VAX-A1 and VAX-PG.
Positive Outlook
- Topline safety, tolerability and immunogenicity results from the VAX-24 Phase 1/2 clinical study by the end of 2022.
- Begin enrollment in a separate Phase 2 study in healthy adults aged 65 and older upon successful completion of the Phase 1 portion of the recently initiated Phase 1/2 study in adults aged 18 to 64.
- Topline safety, tolerability and immunogenicity results from Phase 2 study in adults aged 65 and older are expected to be announced in the first half of 2023.
- Submit its first VAX-24 pediatric IND application to the FDA in the first half of 2023, subject to a pre-IND meeting with the FDA and successful topline results from the VAX-24 Phase 1/2 study in adults 18 to 64 years of age.
- Provide guidance for the anticipated submission of its IND application in adults to the FDA following the announcement of the topline results from the VAX-24 Phase 1/2 study in adults aged 18 to 64 for VAX-XP.
Challenges Ahead
- Potential delays in development timelines.
- Inability to obtain and maintain required regulatory approvals for its vaccine candidates.
- Risks and uncertainties inherent with preclinical and clinical development processes.
- Impacts of COVID-19.
- Sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses.