---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-059252"
form_type: "8-K"
ticker: "INMB"
cik: "0001711754"
company_name: "Inmune Bio, Inc."
filed_at: "2025-06-30T23:59:59+00:00"
generated_at: "2026-05-18T13:25:55.408205+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# INmune Bio Phase 2 MINDFuL trial misses primary endpoint; positive subgroup data in inflammation-biomarker AD patients

## Summary
- Primary cognitive endpoint EMACC not met in mITT (n=200); predefined subgroup with ≥2 inflammation biomarkers (n=100) showed cognitive benefit (effect size 0.27).
- In same subgroup, behavioral benefit on NPI (effect size -0.24) and biological benefit on pTau217 (effect size -0.20).
- XPro well-tolerated; no ARIA-E or ARIA-H; injection site reactions common (80% XPro vs <20% placebo).
- Company to file for Breakthrough Therapy designation; End-of-Phase 2 meeting with FDA scheduled for Q4 2025.
- Additional MINDFuL analyses to be presented at AAIC in Toronto, July 27-31, 2025.

## SEC filing metadata
- accession: 0001213900-25-059252
- form_type: 8-K
- ticker: INMB
- cik: 0001711754
- company_name: Inmune Bio, Inc.
- filed_at: 2025-06-30T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1711754/000121390025059252/0001213900-25-059252-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1711754/000121390025059252/ea0247460-8k_inmune.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-059252
- JSON: https://secwatch.observer/filing/0001213900-25-059252.json
- Plain text: https://secwatch.observer/filing/0001213900-25-059252.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.
