Business
Vaxcyte Reports First Quarter 2023 Financial Results and Provides Business Update
-- Positive Data from VAX-24 Phase 2 Study in Adults Aged 65 and Older Demonstrated Robust Immune Responses Across all 24 Serotypes (ST) at all Doses,
About this update from Vaxcyte, Inc.
[{"type":"text","content":"-- Positive Data from VAX-24 Phase 2 Study in Adults Aged 65 and Older Demonstrated Robust Immune Responses Across all 24 Serotypes (ST) at all Doses, Confirming Prior Phase 2 Results in Adults Aged 50-64 -- -- Full Six-Month Safety Data from Both Adult Studies Demonstrated VAX-24 Safety and Tolerability Results Similar to PCV20 at All Doses Studied -- -- Dosed First Participants in Infant Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease (IPD) -- -- VAX-31 Progressing with Adult Investigational New Drug (IND) Application Submission and Subsequent Clearance Announcement Expected in Second Half 2023 and Topline Phase 1/2 Data in 2024 -- -- $949.9 Million in Cash, Cash Equivalents and Investments as of March 31, 2023, Excluding Net Proceeds of $545.1 Million from Recent Public Offering -- SAN CARLOS, Calif., May 08, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the first quarter ended March 31, 2023 and provided a business update. “We believe the recently announced positive results from the Phase 2 study in adults aged 65 and older confirm the clinical potential of our lead vaccine candidate in the adult population and validate our carrier-sparing, cell-free platform,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “These data support a potential best-in-class profile for VAX-24 as well as our goal of creating PCVs that provide broader coverage and better immune responses compared to the standard-of-care vaccines. We look forward to discussing our Phase 2 program results with regulators as we advance towards a Phase 3 pivotal study for VAX-24 from which we expect topline data in 2025.” “With the recent follow-on equity offering, which generated approximately $545 million in net proceeds, our balance sheet is further strengthened,” said Andrew Guggenhime, President and Chief Financial Officer of Vaxcyte. “This allows us to expand our manufacturing capabilities as we continue advancing our PCV franchise, comprised of VAX-24 and VAX-31, our 31-valent PCV candidate for which we expect to submit and announce the subsequent clearance of our adult IND application in the second half of this ...