Company: INMB
Filing Date: 2025-03-07
Form Type: 424B5
Source: 0001213900-25-021719
Chunk: 7

Company: Inmune Bio, Inc.
Filing Date: 2025-03-07
Form: 424B5
Chunk 7
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 in the United Kingdom. INmune Bio was compensated for CORDStrom used in the trial and was not a sponsor of the Mission
EB study. Investigators recently concluded a double blinded, placebo-controlled arm of the study, which evaluated the safety and efficacy
of CORDStrom in 30 pediatric patients (less than 16 years old) in the UK with intermediate and severe RDEB using a novel cross-over clinical
trial design. Patients were randomized to CORDStrom or placebo arms and received two intravenous infusions two weeks apart and then followed
for 9 months. Each child then crossed over to the other arm and received two doses of placebo or CORDStrom two weeks apart with a further
9-month follow-up.

All patients were treated
as day-cases and no CORDStrom related serious adverse events were reported through the study. Top-line results showed the treatment was
easily administered, well tolerated and there were beneficial effects across all types of patients receiving CORDStrom with respect to
Itch Man Scale, iscorEB clinician score and iscorEB skin involvement. Most notably, CORDStrom significantly reduced itch scores
as measured by the Itch Man Scale. In patients with the most severe disease activity, CORDStrom reduced itch at 3 months and led to a
sustained reduction of over 27% at 6 months. These results demonstrate a clinically meaningful reduction in itch severity sustained over
time. Intermediate group patients showed a broader range of improvements, including reduced skin involvement and less pain as well as
large reduction in itch. The younger patients (less than 10 years old) showed improvements in skin score, indicating better skin
integrity and reduced disease activity. Interviews with patients and caregivers on completing follow up strongly support the clinical
benefits of the therapy; both caregivers and patients were able to correctly identify which treatment had been CORDStrom and which had
been placebo. Those who completed the study are asking to continue on therapy, which the Company intends to pursue as an open-label study.

The Mission EB data form
the basis of a license that was entered into between INmune Bio and GOSH, whereby the Company gains exclusive access to the clinical study
data for commercial uses in exchange for payment of an initiation milestone of £250,000 (approximately $0.3 million) and a single
development milestone of approximately £6 million (approximately $7.8 million) due on receipt of first marketing authorization from