Short answer
Inmune Bio, Inc. (INMB) filed its fiscal 2024 10-K annual report with the SEC on Mar 27, 2025. It reported revenue of $14,000 (−91.0% year over year) and net income of −$42M.
- Top risk flagged: Regulatory risk FDA approval delays or non-approval; potential loss of priority or accelerated review, impacting time-to-market for product candidates
FY2024 key financial metrics · XBRL
- Revenue
- $14,000
- −91.0% YoY
- Net income
- −$42M
- −40.2% YoY
- Operating margin
- -304535.7%
- −285348.0 pp YoY
- EPS (diluted)
- −$2.11
- −26.3% YoY
- ROE
- -131.1%
- −50.7 pp YoY
- Operating cash flow
- −$33M
- −178.5% YoY
Source: XBRL data from the Inmune Bio, Inc. (INMB) FY2024 10-K on SEC EDGAR. USD.
Inmune Bio, Inc. FY2024 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Develops innate immune system-targeted biologic therapies for cancer, neurodegenerative diseases, and rare pediatric disorders
- NEW emphasis: Added CORDStrom stem cell product for recessive dystrophic epidermolysis bullosa (RDEB), pivotal trial complete, plans BLA filing in US 2025-2026
- Strategic shift: Accelerated approval pathways targeted for cancer drug INKmune and Alzheimer’s drug XPro1595, orphan and rare pediatric designations leveraged
- Notable metric: Global Phase II Alzheimer’s trial enrolled 208 patients; CORDStrom pivotal RDEB trial data to support marketing submissions in US, EU, UK in 2025-2026
- Unusual fact: CORDStrom uniquely uses pooled human umbilical cord mesenchymal stem cells with proprietary manufacturing for consistent off-the-shelf cellular medicines
Management Discussion & Analysis
- Net loss $42.1M FY2024 vs $30.0M FY2023; cash $20.9M FY2024 vs $35.8M FY2023, cash burn increasing
- R&D expense $33.2M FY2024 vs $20.3M FY2023, driven by DN-TNF Alzheimer’s $23.8M and INKmune/CORDStrom $4.6M
- Best segment: DN-TNF Alzheimer’s with $23.8M R&D spend; Worst: Other preclinical programs $0.6M, smallest investment
- No dividends or buybacks; funded operations primarily by equity/debt; capex detail not disclosed, focusing on clinical/manufacturing
- Clinical progress key risk: Phase II XPro AD results in June 2025; CORDStrom BLA filing expected late 2025/early 2026; ongoing significant losses cast doubt on going concern
Risk Factors
- Regulatory risk FDA approval delays or non-approval; potential loss of priority or accelerated review, impacting time-to-market for product candidates
- Macroeconomic risk capital depletion risk; cash $20.9M as of Dec 31, 2024 vs $35.8M in 2023 with $42.1M net loss in 2024 risking going concern status
- Operational risk dependency on DN-TNF and INKmune platforms; failure of these platforms threatens core product pipeline and future development
- Competitive risk competition from larger biotech/pharma with greater resources and earlier approved drugs; FDA exclusivity periods up to 3.5 years may hinder approval
- Financial risk continuing losses with accumulated deficit $163.1M; need additional capital to fund ongoing operations and product development
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