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Day One Biopharmaceuticals (DAWN) investor relations material
Day One Biopharmaceuticals Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary4 Nov, 2025
Executive summary
Q3 2025 marked the strongest quarter since launch, with OJEMDA net product revenue reaching $38.5 million, a 15% sequential and up to 92% year-over-year increase, driven by increased adoption, durable treatment persistence, and positive clinical data.
Year-to-date net product revenue totaled $102.6 million, up 89% over 2024, and the company raised its full-year 2025 revenue guidance to $145–$150 million.
OJEMDA received FDA approval in April 2024 for relapsed/refractory pLGG and was added to NCCN guidelines as a recommended therapy for BRAF-altered glioma.
The company ended Q3 2025 with $451.6 million in cash, cash equivalents, and short-term investments, maintaining a strong balance sheet and no debt.
Pipeline progress includes anticipated EMA approval for OJEMDA in Europe by mid-2026 and ongoing enrollment in the global phase 3 FIREFLY-2 trial.
Financial highlights
Q3 2025 total revenue was $39.8 million, with OJEMDA product revenue at $38.5 million, up 15% sequentially and 91.9% year-over-year.
Year-to-date net product revenue reached $102.6 million, up 89% over 2024.
Net loss for Q3 2025 was $19.7 million, compared to net income of $37.0 million in Q3 2024.
R&D expenses were $31.4 million and SG&A expenses were $28.1 million in Q3 2025, both slightly lower year-over-year.
License revenue was $1.3 million in Q3 2025, down from $73.7 million in Q3 2024 due to prior year’s upfront payment.
Outlook and guidance
Full-year 2025 net product revenue guidance raised to $145–$150 million, assuming continued double-digit sequential growth in Q4.
Completion of FIREFLY-2 Phase 3 trial enrollment expected in H1 2026; EMA regulatory decision for OJEMDA anticipated in 2026.
Cash reserves are expected to fund operations for at least 12 months from the filing date.
Q4 expenses expected to increase modestly due to planned commercial and clinical activities.
The company expects R&D expenses to increase as clinical programs advance.
Sustain OJEMDA growth beyond current data?
Impact of NCCN adult glioma inclusion?
Reason for YTD R&D expense reduction?
What is the remaining patient pool at 9+ patient accounts?
What specific insights from 3-year data will drive adoption?
How will Q4 gross-to-net and channel stock impact revenue?
3-year FIREFLY-1 data: post-treatment patient journey
What drove Q3 operating expense decline?
NCCN listing impact on OJEMDA adult use?
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Next Day One Biopharmaceuticals earnings date
Q4 202527 Feb, 2026
Next Day One Biopharmaceuticals earnings date
Q4 202527 Feb, 2026
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Day One Biopharmaceuticals Inc. is a biopharmaceutical company focused on developing and commercializing targeted therapies for cancer patients. The company specializes in identifying and advancing therapies designed for patients with genetically defined cancers, particularly in pediatric and young adult populations. The company is headquartered in Brisbane, California, and its shares are listed on the NASDAQ.
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