Day One Reports Preliminary 2024 OJEMDA™ Net Product Revenue and Highlights 2025 Corporate Priorities

Core Insights - Day One Biopharmaceuticals reported preliminary unaudited net product revenue of approximately $57.2 million for 2024, with$29.0 million generated in the fourth quarter [2][6] - The company ended 2024 with approximately $531.7 million in cash, cash equivalents, and short-term investments, an increase from$366.3 million at the end of 2023 [2][6] - OJEMDA received FDA accelerated approval in April 2024, becoming the first FDA-approved therapy for pediatric low-grade glioma [5] - The company is focused on driving OJEMDA revenue, advancing its pipeline, and maintaining a strong financial position in 2025 [1][13] Financial Performance - Preliminary net product revenues for 2024 were approximately $57.2 million, with the fourth quarter contributing around$29.0 million [2] - Cash, cash equivalents, and short-term investments totaled approximately $531.7 million as of December 31, 2024, compared to$366.3 million on December 31, 2023 [2] Regulatory and Clinical Developments - OJEMDA received FDA accelerated approval for treating patients aged 6 months and older with relapsed or refractory pediatric low-grade glioma [5] - The Centers for Medicare & Medicaid Services approved OJEMDA exclusively for pediatric indications, reducing its Medicaid and 340B minimum rebate percentage from 23.1% to 17.1% [5] - Enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial for tovorafenib is progressing, with over 100 sites activated globally [5] Strategic Initiatives - The company aims to continue growing OJEMDA revenue and advance its existing pipeline, including the FIREFLY-2 Phase 3 trial and DAY301 Phase 1a/b trial [13] - Day One has entered into an exclusive licensing agreement with Ipsen to commercialize tovorafenib outside the U.S. [5] - The company is pursuing business development opportunities to expand its pipeline while maintaining a self-sustaining financial position [13]