Short answer
Celldex Therapeutics, Inc. (CLDX) filed its fiscal 2025 10-K annual report with the SEC on Feb 25, 2026. It reported revenue of $2M (−78.0% year over year) and net income of −$259M.
- Top risk flagged: FDA regulatory delays from recent 43-day government shutdown Oct-Nov 2025 impacting review timelines
FY2025 key financial metrics · XBRL
- Revenue
- $2M
- −78.0% YoY
- Net income
- −$259M
- −63.9% YoY
- Operating margin
- -18599.8%
- −15820.9 pp YoY
- EPS (diluted)
- −$3.90
- −59.2% YoY
- ROE
- -49.1%
- −28.0 pp YoY
- Operating cash flow
- −$211M
- −33.7% YoY
Source: XBRL data from the Celldex Therapeutics, Inc. (CLDX) FY2025 10-K on SEC EDGAR. USD.
Celldex Therapeutics, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business model: Development of therapeutic antibodies targeting mast cell biology for severe inflammatory and autoimmune diseases
- New emphasis on bispecific antibody platform, highlighted by CDX-622 targeting TSLP and SCF with Phase 1 studies initiated in 2024-2026
- Strategic shift toward building a fully integrated, commercial-stage biopharma company with potential for retaining full economic rights or forming partnerships
- Phase 3 enrollment completed for Barzolvolimab in Chronic Spontaneous Urticaria; topline data expected Q4 2026
- Notable sustained efficacy: over 40% of CSU patients maintained complete response at 76 weeks post-dosing with Barzolvolimab
Management Discussion & Analysis
- R&D expenses $245.1M in 2025 vs $163.6M in 2024 and $118.0M in 2023, driven by barzolvolimab program ($198.3M in 2025)
- Barzolvolimab program best performing segment with $198.3M R&D spend; CDX-622 at $19.0M; no revenue or profit data provided
- Management expects topline Phase 3 data for CSU indication in Q4 2026; key risk: lengthy, costly clinical trials, uncertain regulatory approvals, and capital needs
Risk Factors
- FDA regulatory delays from recent 43-day government shutdown Oct-Nov 2025 impacting review timelines
- Global supply chain disruptions threatening clinical trial material supplies and contract manufacturing capacity
- Clinical trial enrollment challenges due to patient recruitment difficulties risking costly delays or trial cancellations
- Market competition risk from other monoclonal antibody developers with more advanced or approved therapies
- $52.5M milestone payment under Kolltan merger may require dilutive stock issuance or additional debt funding
Generated from the filing text; verify against the original. How to read a 10-K
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