Business
Vaxcyte Reports Second Quarter 2022 Financial Results and Provides Business Update
-- Completed Enrollment of Phase 2 Portion of Phase 1/2 Clinical Proof-of-Concept Study Evaluating Safety, Tolerability and Immunogenicity of VAX-24 in Adults
About this update from Vaxcyte, Inc.
[{"type":"text","content":"-- Completed Enrollment of Phase 2 Portion of Phase 1/2 Clinical Proof-of-Concept Study Evaluating Safety, Tolerability and Immunogenicity of VAX-24 in Adults -- -- Announcement of Topline Results from the Phase 1 and Phase 2 Portions of the VAX-24 Proof-of-Concept Study Expected in October or November 2022 -- -- First Participants Dosed in Separate VAX-24 Phase 2 Clinical Study in Adults 65 Years and Older, with Topline Data Expected in the First Half of 2023 -- -- 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 -- -- $361.4 Million in Cash, Cash Equivalents and Investments as of June 30, 2022 -- SAN CARLOS, Calif., Aug. 08, 2022 (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 second quarter ended June 30, 2022 and provided a business update. “Completing enrollment of the Phase 2 portion of our clinical proof-of-concept study in adults is a significant milestone in the advancement of VAX-24, our 24-valent pneumococcal conjugate vaccine (PCV), putting us on track to announce the topline safety, tolerability and immunogenicity results, versus the standard-of-care, in October or November of this year,” said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte. “We expect this study, if successful, to be a driver of further activity across our PCV franchise, including the initiation of a VAX-24 study in infants and advancement of VAX-XP, our PCV candidate with an expanded breadth of coverage of greater than 30 strains.” Mr. Pickering continued, “We believe the positive feedback from the FDA regarding both the adult and pediatric VAX-24 clinical programs, including receiving Fast Track designation in adults, supports an expedited path to deliver the broadest-spectrum PCV designed to prevent this serious disease. With significant upcoming milestones for the VAX-24 program, as well as across our pipeline, we expect continued, meaningful progress in the coming months.” Recent Highlights Completed Enrollment of Phase 2 Portion of VAX-24 Phase 1/2 Clinical Proof-of-Concept Study in Adults: In Ju...