Day One Biopharmaceuticals, Inc. (DAWN) FY2025 10-K Annual Report
Day One Biopharmaceuticals, Inc. (DAWN) 10-K annual report for fiscal year 2025, filed with SEC EDGAR on Feb 24, 2026. This page provides AI-powered analysis including business overview, management discussion & analysis (MD&A), risk factors, and key financial data such as revenue, net income, gross margin, operating margin, and return on equity (ROE) extracted from XBRL.
Day One Biopharmaceuticals, Inc. FY2025 10-K Analysis
Business Overview
- • Core business: Development and commercialization of targeted oncologic therapies for pediatric and adult patients with life-threatening diseases, focusing on breakthrough medicines
- • New emphasis: Commercial launch of FDA-approved OJEMDA (tovorafenib) for relapsed/refractory pediatric low-grade glioma, only once-weekly systemic pLGG therapy
- • Strategic shift: Acquisition and integration of Mersana Therapeutics adding Emi-Le ADC targeting B7-H4 for adenoid cystic carcinoma, expanding oncology portfolio
- • Quantitative highlight: FIREFLY-1 trial shows 53% overall response rate with OJEMDA; Phase 3 FIREFLY-2 trial ongoing with ~140 sites in 7 global regions, enrollment completion expected H1 2026
- • Noteworthy fact: Ipsen License Agreement generated $70.8M upfront plus $40M equity investment; regulatory submission of tovorafenib to EMA validated, decision anticipated in 2026
Risk Factors
- • Regulatory risk: Dependency on FDA approval and exclusivity for OJEMDA, with increased product revenue $155.4M driven by U.S. sales
- • Macroeconomic risk: Potential impact from global economic volatility, inflation, trade barriers, and geopolitical conflicts affecting capital raising efforts
- • Operational risk: Significant reliance on third-party CROs and CMOs for clinical trials and manufacturing, with $70.3M spent on tovorafenib-related outsourcing in 2025
- • Competitive risk: Licensing to Ipsen for tovorafenib commercialization outside U.S. exposes company to market competition and partner execution risk
- • Financial risk: Accumulated deficit $661.4M with cash $441.1M, raising capital needed through equity/debt with risk of dilution and restrictive covenants
Day One Biopharmaceuticals, Inc. FY2025 Key Financial MetricsXBRL
Revenue
$158M
▲ +20.6% YoY
Net Income
-$107M
▼ -12.4% YoY
Operating Margin
-80.8%
▲ +8489bp YoY
Net Margin
-67.8%
▲ +496bp YoY
ROE
-24.3%
▼ -533bp YoY
Total Assets
$508M
▼ -12.9% YoY
EPS (Diluted)
$-1.04
▼ -2.0% YoY
Operating Cash Flow
-$104M
▼ -32.8% YoY
Source: XBRL data from Day One Biopharmaceuticals, Inc. FY2025 10-K filing on SEC EDGAR. All figures in USD.
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