secwatch.observer — SEC 8-K summary
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Issuer:     Inmune Bio, Inc. (INMB)
CIK:        0001711754
Form:       8-K
Filed at:   2025-02-10T23:59:59+00:00
Accession:  0001213900-25-011733
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 1.01, 1.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

INmune Bio licenses MissionEB data, plans BLA for CORDStrom in pediatric RDEB
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- Plans to submit BLA in 2025 for CORDStrom to treat pediatric RDEB, supported by positive Phase 2 MissionEB data in 30 patients.
- Licensed exclusive commercial rights to MissionEB data from Great Ormond Street Hospital for £250k upfront and up to £6M milestone on first marketing authorization.
- FDA granted Rare Pediatric Disease Designation (RPDD) Dec 2024 and Orphan Drug Designation (ODD) Jan 2025, preserving PRV eligibility.
- CORDStrom well tolerated; severe RDEB patients had >27% sustained itch reduction at 6 months; younger and intermediate patients showed skin and pain improvements.
- Terminated existing SVB loan agreement with zero balance and no penalty; no financial impact.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1711754/000121390025011733/0001213900-25-011733-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1711754/000121390025011733/ea0230277-8k_inmune.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-011733

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