INmune Bio, Inc. (INMB) Market Cap
INmune Bio, Inc. has a market capitalization of $38M.
Financials based on reported quarter end 2025-12-31
Price: $1.43
▲ 0.06 (4.38%)
Market Cap: 38.02M
NASDAQ · time unavailable
CEO: David J. Moss
Sector: Healthcare
Industry: Biotechnology
IPO Date: 2019-02-04
Website: https://www.inmunebio.com
INmune Bio, Inc. (INMB) - Company Information
Market Cap: 38.02M · Sector: Healthcare
INmune Bio, Inc., a clinical-stage immunotherapy company, focuses on developing drugs to reprogram the patient's innate immune system to treat disease. The company develops and commercializes product candidates to treat hematologic malignancies, solid tumors, and chronic inflammation. Its development programs include INKmune, which focuses on treating women with relapse refractory ovarian carcinoma and patients with high-risk myelodysplastic syndrome; INB03, an immunotherapy that treats patients with hematologic malignancies and solid tumors; and XPro1595 for the treatment of Alzheimer's disease. The company has license agreements with Xencor, Inc.; Immune Ventures, LLC; University of Pittsburg; and University College London. INmune Bio, Inc. was incorporated in 2015 and is headquartered in Boca Raton, Florida.
Analyst Sentiment
Based on 9 ratings
Analyst 1Y Forecast: $0.00
Average target (based on 1 sources)
Consensus Price Target
Low
$22
Median
$22
High
$22
Average
$22
Potential Upside: 1438.5%
Price & Moving Averages
Fundamentals Overview
📊 AI Financial Analysis
Powered by StockMarketInfo"INMB reported net income of $86.6M and EPS of $1.72 for the quarter/period ended 2025-12-31. Revenue was reported as $0 in the provided dataset, so profitability should be interpreted cautiously without accompanying top-line context. Net margin and revenue-driven operating metrics cannot be reliably calculated from the data given. Free cash flow was negative at -$3.7M (operating cash flow: -$3.0M; capex: -$0.7M), indicating ongoing cash burn despite profitability at the bottom line. Balance sheet strength appears relatively solid on a net-debt basis: total assets were ~$32.4M versus total liabilities of ~$8.8M, leaving equity of ~$23.5M. Importantly, net debt is -$23.7M, implying the company holds net cash rather than net borrowings. From a shareholder-return perspective, market performance has been weak: the stock is at $1.13 with a -85.5% 1-year change (and -45.4% over 6 months). Dividends are $0 and no buyback data was provided, so total shareholder return is primarily driven by capital appreciation—which has been negative. Analyst consensus target of $22 (per the dataset) conflicts with the current price level, suggesting either significant uncertainty or outdated/conditional assumptions in the target."
Revenue Growth
Revenue is shown as $0 in the dataset for 2025-12-31, preventing assessment of growth, stability, or drivers.
Profitability
EPS of $1.72 with net income of $86.6M indicates reported profitability, but margin and operating efficiency are hard to validate without reliable revenue and cash/earnings linkage.
Cash Flow Quality
Operating cash flow was -$3.0M and free cash flow was -$3.7M, indicating cash burn. Dividends were $0 and no buyback figures were provided.
Leverage & Balance Sheet
Net debt is -$23.7M (net cash position). Assets of ~$32.4M vs liabilities of ~$8.8M suggests reasonable balance-sheet resilience despite negative FCF.
Shareholder Returns
Total shareholder value creation looks weak based on price performance: -85.5% over 1 year. With $0 dividends and no buyback data, shareholder returns are largely negative.
Analyst Sentiment & Valuation
Current price is $1.13 versus a $22 consensus target in the dataset. The large discrepancy makes valuation/consensus signal uncertain, and no P/E or FCF yield metrics were provided.
Disclaimer:This analysis is AI-generated for informational purposes only. Accuracy is not guaranteed and this does not constitute financial advice.
So what: INmune Bio’s Q4’25 read-through is dominated by two regulatory timelines and one commercial-access ambition. CORDStrom (RDEB) appears to be de-risked on mechanistic understanding and CMC consistency, with management citing clinical meaningful wound healing plus itch/QoL improvements and an aggressive plan to file U.K. MAA by end of summer/mid-summer 2026, then EMA MAA a few months later and FDA BLA toward year-end. Management targets feedback/approvals in 2027 and hopes to supply patients in 2027. The key operational wrinkle is FDA sensitivity to U.K. donor materials, forcing new U.S.-tested master seedstocks and infectious disease marker testing in U.S. accredited labs—though they claim the FDA questions match MHRA aside from this. XPro’s outlook is constructive but not clean: MINDFuL missed the primary endpoint (impairment of $16.5M), yet enriched Phase III planning is underway after FDA end-of-Phase II minutes with positive initial feedback on accelerated pathways. Capital actions (registered direct + ATM) keep runway to Q1 2027.
Growth Catalysts
- CORDStrom RDEB: additional patient data showing clinical meaningful wound healing, reductions in itch, and improvements in quality of life with a favorable safety profile
- CORDStrom: disclosed mechanistic clarity (cytokine-mediated shift from M1 inflammatory macrophages to M2 non-inflammatory wound-healing phenotype; IL-10 involvement) supporting regulatory CMC/potency work
- XPro Alzheimer’s (MINDFuL): Phase II results used to design Phase III; adaptive Phase IIb decision point at 9 months (go/no-go) and seamless continuation to 18-month registrational trial using same primary endpoint concept as lecanemab/donanemab (CDR-SB)
- XPro: FDA alignment on development path after MINDFuL and end-of-Phase II minutes indicating positive initial feedback on accelerated approval pathways (per management)
Business Development
- CORDStrom: seeking business partnerships to develop broader indications beyond RDEB through clinical trials (no names provided)
- XPro: active partnership and funding discussions to support late-stage development (no partner names provided)
- XPro: question raised about interactions with former partners at “ABPD”; management responded with ongoing discussions with groups but did not name any
Financial Highlights
- Net loss attributable to common stockholders: ~$45.9M in FY2025 vs ~$42.1M in FY2024
- R&D expense: ~$20.7M in FY2025 vs ~$33.2M in FY2024 (decrease attributed to lower Alzheimer's trial expenses in 2025)
- G&A expense: ~$10.3M in FY2025 vs ~$9.5M in FY2024
- Intangible asset impairment: full impairment of ~$16.5M in 2025 following release of MINDFuL Phase II results (stated as not meeting clinical endpoint)
- Equity issuance: sold 3.0M shares in registered direct offering for net proceeds ~$17.4M; sold ~1.3M shares in ATM offerings for net proceeds ~$10.1M
- Balance sheet liquidity: cash & cash equivalents ~$24.8M at 12/31/2025; ~26.6M shares outstanding as of 3/30/2026
- No quarter EPS/Revenue figures disclosed in the transcript; discussion is operational/capital focused
Capital Funding
- Registered direct offering: 3.0M shares, net proceeds ~$17.4M
- ATM: ~1.3M shares, net proceeds ~$10.1M
- Cash: ~$24.8M at 12/31/2025
- Cash runway: management stated cash sufficient to fund operations through Q1 2027 (based on current operating plan)
- No debt balance disclosed in the transcript
Strategy & Ops
- CORDStrom regulatory/CMC readiness: highlighted batch-to-batch manufacturing consistency and reproducibility for commercial-grade uniformity
- CORDStrom filing timeline (per management): preparing regulatory submissions in U.K. and U.S.; expanding to EMA/EU after U.K. MAA
- Supply/CMC difference for FDA: FDA sensitivity to using U.K.-sourced umbilical cord donor material; company must screen U.K. donors for standard infectious disease markers and test them in U.S. accredited labs; management is creating new master seedstocks from donors ethically testable in the U.S.
- xPro trial design: adaptive Phase III path with Phase IIb decision at 9 months; Phase III runs 18 months to capture cognitive effects appearing at 6 months and functional effects required by FDA
- Alzheimer’s program status: MINDFuL did not achieve top-line primary endpoint (and prior impairment reflects this), but management argues the totality of XPro data supports conviction and informs Phase III enrichment strategy
Market Outlook
- CORDStrom MAA: file in the U.K. by end of summer 2026 (also described as “mid-summer 2026”)
- CORDStrom EMA: submit MAA to EMA a few months after U.K. MAA filing
- CORDStrom FDA: submit BLA towards end of 2026
- Expected feedback/approvals: management said “feedback from all 3 geographies in ’27, if not, approvals by then”
- CORDStrom patient access: hope to supply to RDEB patients in 2027
- XPro Phase III: Phase IIb decision point at 9 months; seamless continuation to 18-month registrational stage with CDR-SB as primary endpoint
Risks & Headwinds
- MINDFuL Alzheimer’s: Phase II trial did not meet the clinical endpoint; intangible asset impairment of ~$16.5M recorded; top-line primary endpoint not achieved (transcript explicitly states this)
- FDA donor-material constraint: need to create U.S.-tested master seedstocks due to FDA sensitivity about U.K. donor materials; could affect CMC timelines/complexity despite management stating products can be made from U.S.-tested donors before BLA submission
- Regulatory timing risk: stated timelines are “highly aggressive” for U.K., EU, and U.S. submissions; management claims deadlines met so far but still subject to execution/regulatory review
- Partnering dependency: late-stage funding/partnership needs for XPro and broader-indication partnerships for CORDStrom are explicitly required
Sentiment: MIXED
Note: This summary was synthesized by AI from the INMB Q4 2025 earnings transcript. Financial data is complex; please verify all metrics against official SEC filings before making investment decisions.