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Sep 30, 2022
Vaxcyte Q3 2022 Earnings Report
Vaxcyte reported positive topline data from Phase 1/2 proof-of-concept study of its 24-Valent Pneumococcal Conjugate Vaccine (PCV) candidate and provided a business update.
Key Takeaways
Vaxcyte announced positive results from its Phase 1/2 clinical proof-of-concept study, demonstrating VAX-24's potential for broader coverage and better immune responses relative to the standard-of-care. The company's cash, cash equivalents and investments were $366.2 million as of September 30, 2022, excluding net proceeds of approximately $650.7 million from a recent public offering.
Reported Positive Topline Data from VAX-24 Phase 1/2 Proof-of-Concept Study in Adults Aged 18-64.
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.
Cash, cash equivalents and investments were $366.2 million as of September 30, 2022, excluding net proceeds of approximately $650.7 million from the follow-on offering completed in October 2022.
Forward Guidance
Vaxcyte anticipates multiple VAX-24 milestones, including topline results from a second Phase 2 study in older adults and the initiation of a Phase 2 study in infants, in the first half of 2023. Additionally, the company is progressing VAX-XP, its PCV candidate with 31 strains of coverage, and expects to submit an adult IND application in the second half of 2023.
Positive Outlook
- Topline safety, tolerability and immunogenicity data from the Phase 2 study in adults 65 and older are anticipated in the first half of 2023.
- Final results with the 6-month safety data from the two Phase 2 adult studies are anticipated in the first half of 2023.
- Following the receipt of the final safety reports from the two adult Phase 2 studies, regulatory interactions to inform the Phase 3 program are anticipated in the second half of 2023.
- The infant IND application submission and the Phase 2 study initiation are both anticipated in first half of 2023.
- The IND application submission for VAX-XP is anticipated in the second half of 2023.
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