On November 6, 2023, Vaxcyte Inc (PCVX, Financial), a clinical-stage vaccine innovation company, announced its financial results for the third quarter ended September 30, 2023, and provided a business update. The company reported significant strides towards its goal of building a best-in-class PCV franchise, including VAX-24 and VAX-31, with the intent of delivering the broadest-spectrum of coverage against invasive pneumococcal disease.
Business Highlights and Anticipated Milestones
Vaxcyte Inc (PCVX, Financial) completed a successful End-of-Phase 2 meeting with the FDA for VAX-24, with topline Phase 3 data in adults expected in 2025. The company also received FDA clearance of VAX-31 Adult IND Application, with Phase 1/2 Study initiation expected this quarter and topline data expected in the second half of 2024. Furthermore, the company expanded its collaboration with Lonza for global commercial manufacturing of its vaccine candidates, VAX-24 and VAX-31.
The company is advancing the clinical development of its PCV programs with several anticipated key upcoming milestones, including topline safety, tolerability, and immunogenicity data from the Phase 3 pivotal non-inferiority study in adults in 2025 for VAX-24 Adult Program, topline data from the primary three-dose immunization series of the infant Phase 2 study by 2025 for VAX-24 Infant Program, and initiation of the Phase 1/2 study in the fourth quarter of 2023 for VAX-31 Adult Program.
As of September 30, 2023, Vaxcyte Inc (PCVX, Financial) reported cash, cash equivalents, and investments of $1,434.2 million, compared to $957.9 million as of December 31, 2022. The company’s R&D expenses were $97.4 million for the three months ended September 30, 2023, compared to $47.7 million for the same period in 2022. The increase was primarily due to higher manufacturing expenses related to the planned VAX-24 Phase 3 clinical trials and the potential commercial launches of VAX-24 and VAX-31, as well as an increase in personnel-related expenses related to R&D growth. The company’s net loss for the three months ended September 30, 2023, was $92.7 million, compared to $57.9 million for the same period in 2022.
Vaxcyte Inc (PCVX, Financial) is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. The company is developing broad-spectrum conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases.
Explore the complete 8-K earnings release (here) from Vaxcyte Inc for further details.