secwatch.observer — SEC 8-K summary
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Issuer:     Inmune Bio, Inc. (INMB)
CIK:        0001711754
Form:       8-K
Filed at:   2025-06-30T23:59:59+00:00
Accession:  0001213900-25-059252
Event type: other_material
Sentiment:  neutral
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1711754/000121390025059252/0001213900-25-059252-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1711754/000121390025059252/ea0247460-8k_inmune.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-059252

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer