Company Overview and Financial Highlights - Day One is a commercial-stage biopharmaceutical company focused on developing targeted medicines for childhood and adult diseases[11] - As of March 31, 2025, Day One had approximately $473 million in cash, cash equivalents, and short-term investments[16,82] - OJEMDA net product revenue since launch reached $87.7 million[43] - Q1 2025 OJEMDA net product revenue was $30.5 million, representing an 11% increase compared to Q4 2024[43,47] - Cumulative prescriptions for OJEMDA since launch totaled 2,571 as of March 31, 2025[43] OJEMDA Clinical Data and Market Opportunity - OJEMDA demonstrated an overall response rate (ORR) of 51% in 76 evaluable patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation[29,30] - The addressable U.S opportunity for OJEMDA is estimated to be approximately 2,000-3,000 patients[38,39] Pipeline Development - Enrollment completion is expected in the first half of 2026 for the FIREFLY-2 pivotal Phase 3 trial in front-line pLGG[18] - The first dose cohort for DAY301, a PTK7-targeted ADC, was cleared in January 2025[18,65]
Day One Biopharmaceuticals (DAWN) Earnings Call Presentation