On February 24, 2026 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its financial results for the fourth quarter and full year 2025, and reaffirms its outlook for 2026.
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"2025 was a seminal year for Day One, marked by significant achievements across every pillar of our organization. By maintaining our strong commercial execution, leveraging our expertise to extend into additional rare cancers, and steadily advancing our early-stage pipeline, we are delivering on our mission to bring new medicines to people of all ages with life-threatening diseases," said Jeremy Bender, Ph.D., chief executive officer of Day One. "The commercial momentum we’ve established for OJEMDA and the important upcoming clinical data updates across our full pipeline position us for strong growth in 2026 and beyond."
OJEMDA Commercial Performance
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OJEMDA net product revenue of $52.8 million and $155.4 million for the fourth quarter and full year 2025, respectively
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Full-year 2025 net product revenue represented 172% year-over-year growth, with double-digit sequential quarterly growth throughout the year
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Fourth quarter prescription volumes increased to 1,394 and total 2025 prescriptions were 4,635, representing 181% growth versus 2024 (April launch), and demonstrating strong and growing patient demand, increasing treatment persistence and expanding prescriber adoption
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Company reaffirmed its previously announced 2026 U.S. OJEMDA net product revenue guidance of $225 million to $250 million
Clinical and Pipeline Highlights
FIREFLY-1 Progress in 2025 and Frontline pLGG FIREFLY-2 Trial Enrollment Complete in 2026
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Updated three-year data from the pivotal Phase 2 FIREFLY-1 trial presented at the Society for Neuro-Oncology Annual Meeting in November 2025, reinforcing the durability of response and long-term safety profile of OJEMDA in patients with relapsed or refractory pLGG
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Long term follow-up data from FIREFLY-1 demonstrate that time to next treatment analyses better reflected clinical decision-making among FIREFLY-1 investigators versus radiographic-only tumor progression (as assessed via traditional progression free survival analyses)
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Enrollment in the pivotal Phase 3 FIREFLY-2 trial evaluating OJEMDA in patients with frontline pLGG remains on track, with full enrollment anticipated in the first half of 2026
Pipeline Progress in 2026
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Updated Phase 1 clinical data on Emi-Le, a B7-H4-directed ADC acquired from Mersana, expected to be available mid-2026
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The Phase 1a clinical trial of DAY301, a PTK7-targeted ADC, is progressing through dose escalation, with initial clinical data and program update planned for the second half of 2026
2025 Financial Summary
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Net Product Revenue: OJEMDA net product revenues were $52.8 million and $155.4 million for the fourth quarter and full year 2025, respectively
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License Revenue: License revenues from the sale of ex-U.S. commercial rights for tovorafenib were $0.9 million and $2.8 million for the fourth quarter and full year 2025, respectively
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R&D Expenses: Research and development expenses were $40.9 million and $148.1 million for the fourth quarter and full year 2025, respectively, as compared to $61.8 million and $227.7 million for the same periods in 2024
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SG&A Expenses: Selling, general and administrative expenses were $34.2 million and $120.6 million for the fourth quarter and full year 2025, respectively, as compared to $29.8 million and $115.5 million for the same periods in 2024
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Net Loss: Net loss totaled $21.3 million and $107.3 million for the fourth quarter and full year 2025, respectively, with non-cash stock-based compensation expense of $11.1 million and $44.4 million for the same periods. By comparison, net loss totaled $65.7 million and $95.5 million for the fourth quarter and full year 2024, respectively, with non-cash stock-based compensation expense of $11.0 million and $48.3 million for the same periods
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Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $441.1 million as of December 31, 2025
Upcoming Events
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46th Annual TD Cowen Health Care Conference
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Management will participate in a fireside chat on Tuesday, March 3 at 9:10 a.m. Eastern Time. A live and archived audio webcast of the discussion will be available by visiting the Events section of the Company’s website
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2026 Leerink Partners Global Healthcare Conference
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Management presentation on Wednesday, March 11 at 1:40 p.m. Eastern Time. A live and archived audio webcast of the discussion will be available by visiting the Events section of the Company’s website
Conference Call
Day One will host a conference call and webcast today, February 24 at 4:30 p.m. Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Media & Investors page. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30 days following the event.
(Press release, Day One, FEB 24, 2026, View Source [SID1234662905])