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Jun 30, 2021
Vaxcyte Q2 2021 Earnings Report
Reported financial results for the second quarter ended June 30, 2021 and provided a business update.
Key Takeaways
Vaxcyte reported a net loss of $23.7 million for the second quarter of 2021, with cash, cash equivalents, and investments totaling $341.0 million. The company is advancing its VAX-24 program and received additional funding from CARB-X to advance VAX-A1.
Advanced VAX-24 IND-Enabling Activities, completing manufacturing and testing of 24 GMP conjugated DS.
Received an additional $3.2 million award from CARB-X to advance development of VAX-A1.
Published new research supporting the power of Vaxcyte’s Technology Platform.
Strengthened Advisory Board with Appointment of Dr. Emmanuel Walter from Duke University School of Medicine.
Vaxcyte
Vaxcyte
Forward Guidance
Vaxcyte anticipates several key milestones including submitting an IND application for VAX-24 between January and June 2022 and initiating IND-enabling studies for VAX-A1 in the second half of 2021.
Positive Outlook
- VAX-24: Expects to submit an IND application to the FDA between January and June 2022.
- VAX-24: Anticipates announcing topline data between late 2022 and early 2023 from the ensuing Phase 1/2 clinical proof-of-concept study in adults aged 50 and older.
- VAX-A1: Plans to initiate IND-enabling studies in the second half of 2021.
- VAX-PG: Expects to nominate a final vaccine candidate in the first half of 2022.
Challenges Ahead
- Extended timelines required to access certain critical components due to the COVID-19 pandemic.
- Availability of research support to complete preclinical proof-of-concept studies may impact timelines.
- Potential delays or inability to obtain and maintain required regulatory approvals for its vaccine candidates.
- Risks and uncertainties inherent with preclinical and clinical development processes.
- Sufficiency of cash and other funding to support Vaxcyte’s development programs and other operating expenses.