Inmune Bio, Inc. (INMB)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 showed reduced net loss and lower R&D spend year on year; EPS of -$0.43 beat Wall Street consensus of -$0.47, aided by tightened operating spend and small revenue ($0.05M) uplift .
• Management reiterated June 2025 top-line readout for the Phase 2 Alzheimer’s MINDFuL (AD02) trial; emphasized EMAC as preferred cognitive measure and highlighted a substantial APOE4-driven market opportunity for XPro™ .
• Program timelines shifted: INKmune Phase II enrollment target moved to year-end (vs earlier guidance for mid-2025), while CORDStrom™ BLA timing narrowed to early 2026 .
• Key stock catalysts near term: AD02 top-line in June, PSMA-PET lesion data in INKmune, and clarity on NIH funding for XPro in depression .

What Went Well and What Went Wrong

What Went Well

• EPS beat: Q1 2025 EPS of -$0.43 vs S&P Global consensus -$0.47; revenue of $0.05M vs $0.00 consensus, driven by lower R&D and steady G&A .
• Alzheimer’s trial momentum: Database lock process on track for mid-to-late June; strong narrative around EMAC and pTau217 as clinically relevant biomarkers .
• INKmune safety and signals: No adverse events; early PSMA-PET reads suggest some lesions resolved in lowest-dose cohort; manufacturing supply secured .

Quotes:

• “We remain on track… mid- to late June… confident we will report results that will change the care of patients with early Alzheimer’s disease.”
• “INKmune remains extremely well tolerated… some lesions have resolved completely following INKmune treatment.”

What Went Wrong

• Timeline slippage: INKmune Phase II enrollment completion moved from mid-2025 target to “before year end,” implying a delay .
• Minimal revenue base: The company remains largely pre-revenue; margin analysis is not meaningful given near-zero sales .
• Cash runway: CFO indicated cash sufficiency only through Q3 2025, highlighting funding dependency around upcoming milestones and NIH financing for depression study .

Financial Results

Income Statement and Operating Profile (Quarterly)

Notes: Asterisked values retrieved from S&P Global.

Liquidity, Shares, and Cash Burn

Results vs Wall Street Consensus (S&P Global)

Notes: Values retrieved from S&P Global.

Year-over-Year KPIs (Q1)

Margin commentary: Net income and EBIT margins are not meaningful given negligible revenue base .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• RJ Tesi on Alzheimer’s readout: “We remain on track… mid- to late June… we are confident we will report results that will change the care of patients with early Alzheimer’s disease.”
• On APOE4 market: “EU and U.K. have approved lecanemab… exclude patients who carry 2 APOE4 alleles… we should have an exclusive biologically based market [for APOE4 homozygotes].”
• CSO Mark Lowdell on INKmune: “None of the patients treated in Phase II to date has shown any adverse event… some lesions have resolved completely following INKmune treatment.”
• CFO David Moss on liquidity: “Cash and cash equivalents of approximately $19.3 million… sufficient to fund operations through Q3 of 2025.”

Q&A Highlights

• Phase 3 timeline: Management will seek a Type B end-of-Phase 2 meeting in 4Q 2025/2026 to align design; avoids pre-specifying size until FDA feedback; expects larger trial with potentially fewer biomarkers .
• EMAC vs CDR: Team emphasized EMAC captures early AD cognitive change with less noise; if CDR is equivocal, likely a power issue; correlations between EMAC and CDR observed .
• APOE4 homozygotes: ~15% in lecanemab/donanemab trials; INMB’s trial ~9%; strategic opportunity where anti-amyloid labels restrict this subgroup (EU/UK) .
• pTau217: Early reductions in CSF markers noted; positioned as responsive PD biomarker, complementary to clinical endpoints .
• CORDStrom regulatory context: Abeona gene therapy viewed as complementary (local skin), while CORDStrom positioned as systemic therapy addressing broader EB burden .

Estimates Context

• Q1 2025 EPS and revenue exceeded consensus: EPS -$0.43 vs -$0.47; revenue $0.05M vs $0.00 .
• Coverage remains sparse; consensus recommendation text unavailable; target price mean $5.25 reported with limited dispersion.
  Notes: Values retrieved from S&P Global.

Key Takeaways for Investors

• Near-term binary catalyst: June AD02 top-line remains the primary stock driver; management’s biomarker-led narrative (EMAC, pTau217) seeks to anchor interpretation .
• Strategic differentiation: APOE4 homozygote exclusion from anti-amyloid labels in EU/UK positions XPro for a defined market niche if efficacy and safety hold .
• INKmune momentum: Clean safety and early lesion-resolution observations warrant attention; enrollment shift to year-end signals operational execution risk but also ongoing signal development .
• Funding vigilance: Runway through Q3 2025; potential need for capital contingent on AD02 data, Phase 3 planning, and NIH timelines .
• CORDStrom de-risking: Orphan/Rare Pediatric designations and MissionEB trial data support BLA pathway; early 2026 filing guides medium-term optionality .
• EPS beat driven by disciplined R&D spend and stable G&A; maintain focus on opex trajectory into pivotal planning .
• Trading implications: Expect heightened volatility into June readout; position sizing should reflect binary outcome risk and liquidity constraints.

Appendix: Source Documents

• Q1 2025 8-K 2.02 and press release: full financial tables and program updates .
• Q1 2025 earnings call transcripts: management remarks, Q&A themes, and program timelines – – –.
• Prior quarters: Q3 2024 8-K press release and financials –; FY2024/YE 8-K press release –.

Notes on SPGI data usage: Asterisked values in tables are retrieved from S&P Global.