Enliven Therapeutics, Inc. (ELVN) FY2025 10-K Annual Report
Enliven Therapeutics, Inc. (ELVN) 10-K annual report for fiscal year 2025, filed with SEC EDGAR on Mar 3, 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.
Enliven Therapeutics, Inc. FY2025 10-K Analysis
Business Overview
- • Core business: Clinical-stage biopharma developing selective small molecule therapeutics targeting validated biology using precision medicine
- • New emphasis on ELVN-001, a selective ATP-competitive BCR-ABL TKI for CML addressing resistance, off-target toxicity, and dosing challenges
- • Strategic pivot to prioritize ELVN-001; exploring strategic alternatives for ELVN-002 to focus resources on lead program
- • ENABLE Phase 1 trial enrolled 90 patients; 47% cumulative MMR rate by 24 weeks with favorable safety in heavily pretreated CML patients
- • CEO Rick Fair joined Dec 2025, bringing 25+ years pharma leadership including commercial launches for $23B oncology portfolio
Management Discussion & Analysis
- • No revenue generated in FY 2025 or 2024; no expected revenue in foreseeable future
- • Net loss $103.7M in 2025 vs $89.0M in 2024; operating expenses $119.7M vs $104.6M; operating margin negative and worsening
- • R&D increased to $85.9M in 2025 from $80.8M in 2024; ELVN-001 external costs up $7.8M, ELVN-002 external costs down $12.8M; G&A rose to $33.8M from $23.8M driven by $9.6M higher stock comp
- • Cash, cash equivalents and marketable securities $462.6M at December 31, 2025; raised $230M in June 2025 Public Offering, $90M in March 2024 Private Placement, $40M via Sales Agreement through 12/31/2025
- • Management expects operating losses and R&D expenses to increase; cash runway covers at least next 12 months; key risks include clinical trial progress, regulatory approval, need for further capital raises, and macroeconomic/geopolitical uncertainties
Risk Factors
- • FDA regulatory risk: potential delays or denials if ELVN-001 clinical trial design or data interpretation not accepted, requiring additional clinical studies
- • Geopolitical exposure: clinical development reliant on sites in U.S., Europe and China, subject to global trade tensions and tariffs impact
- • Supply chain vulnerability: changes in manufacturing process require FDA comparability analysis and approval, possibly delaying clinical trials
- • Competitive risk: dependency on ELVN-001 amid high biopharma attrition rates and competing therapies impacting commercial acceptance
- • Financial risk: accumulated deficit $347.2M, net loss $103.7M in 2025, need for substantial additional funding to sustain operations
Enliven Therapeutics, Inc. FY2025 Key Financial MetricsXBRL
Net Income
-$104M
▼ -16.5% YoY
ROE
-22.6%
▲ +617bp YoY
Total Assets
$476M
▲ +46.2% YoY
EPS (Diluted)
$-1.83
▲ +3.2% YoY
Operating Cash Flow
-$70M
▲ +3.9% YoY
Source: XBRL data from Enliven Therapeutics, Inc. FY2025 10-K filing on SEC EDGAR. All figures in USD.
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