Vaxcyte Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Core Insights - Vaxcyte, Inc. has made significant progress in its clinical programs for broad-spectrum pneumococcal conjugate vaccines (PCVs), with plans to initiate a Phase 3 study for VAX-31 by mid-2025 and to announce topline data in 2026 [1][3][15] - The company raised approximately $2.2 billion in net proceeds from two follow-on equity offerings in 2024, strengthening its financial position with$3.1 billion in cash and equivalents as of December 31, 2024 [2][20] - Vaxcyte's VAX-31 and VAX-24 candidates have shown promising results in clinical trials, with VAX-31 receiving Breakthrough Therapy designation from the FDA for the prevention of invasive pneumococcal disease (IPD) in adults [9][18] Clinical Development - Vaxcyte is on track to announce topline safety, tolerability, and immunogenicity data from the VAX-24 infant Phase 2 study by the end of Q1 2025, followed by booster dose data by the end of 2025 [1][11] - The VAX-31 infant Phase 2 study has progressed to its final stage, with topline data expected in mid-2026 [1][12] - Positive topline results from the Phase 1/2 study of VAX-31 in adults aged 50 and older were reported, demonstrating a safety profile similar to Prevnar 20 and robust immune responses [4][5] Financial Performance - For the year ended December 31, 2024, Vaxcyte reported a net loss of $463.9 million, compared to a net loss of$402.3 million in 2023 [20][25] - Research and development expenses increased to $476.6 million in 2024 from$332.3 million in 2023, primarily due to heightened development activities for adult and infant PCV programs [20][25] - The company incurred $127.8 million in capital and facility buildout expenditures related to the construction of a dedicated manufacturing suite to support potential global commercialization [20][25] Leadership and Strategic Initiatives - Vaxcyte has strengthened its leadership team with key appointments, including Harp Dhaliwal as Chief Technical Operations Officer and Roger Nosal as Head of Global Regulatory and Quality Assurance [14][10] - The company is investing in its early-stage pipeline, targeting antibiotic-resistant pathogens such as Group A Strep and Shigella, alongside its PCV candidates [3][18]