Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 209

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 209
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 Great Ormond Street Hospital (GOSH),
London, in connection with the MissionEB study, which was primarily funded by a grant from the National Institute for Health and
Care Research (NIHR) 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 United Kingdom with intermediate and severe RDEB using a novel cross-over
clinical trial design. Patients were randomized to CORDStrom or placebo arms and received 2, 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.

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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