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Sep 30, 2021
Vaxcyte Q3 2021 Earnings Report
Vaxcyte reported financial results for the third quarter ended September 30, 2021 and provided a business update.
Key Takeaways
Vaxcyte reported a net loss of $26.6 million for the third quarter of 2021. The company's cash, cash equivalents and investments were $318.3 million as of September 30, 2021. Vaxcyte expects to submit the VAX-24 IND application to the FDA in the first quarter of 2022.
Advanced VAX-24 Investigational New Drug (IND)-Enabling Activities, completing manufacture of GMP drug product and GLP toxicology study.
Presented Preclinical Data Supporting the Potential of VAX-XP, showing conjugate-like immune responses for all 31 serotypes.
Initiated VAX-A1 IND-Enabling Activities, advancing development of a novel conjugate vaccine designed to prevent infections caused by Group A Streptococcus pyogenes (Strep) bacteria.
Enhanced Board of Directors with Appointment of Four Industry Veterans and appointed Harp Dhaliwal as Senior Vice President, Commercial Manufacturing & Supply Chain.
Forward Guidance
The Company currently expects to submit the VAX-24 IND application to the FDA in the first quarter of 2022 and anticipates announcing topline data from the ensuing Phase 1/2 clinical proof-of-concept study in adults between late 2022 and early 2023.
Positive Outlook
- VAX-24: The Company currently expects to submit the VAX-24 IND application to the FDA in the first quarter of 2022
- Following the anticipated completion of the remaining drug product testing and release, as well as documentation of stability.
- Vaxcyte continues to anticipate announcing topline data from the ensuing Phase 1/2 clinical proof-of-concept study in adults between late 2022 and early 2023.
- Vaxcyte expects to nominate a final vaccine candidate for VAX-PG, its novel therapeutic vaccine designed to treat periodontal disease, in the first half of 2022.
- Following the nomination of its final VAX-A1 vaccine candidate in the first quarter of 2021, the Company initiated IND-enabling studies in the second half of 2021, consistent with prior guidance.
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