Company: INMB
Filing Date: 2025-10-30
Form Type: 10-Q
Source: 0001213900-25-104141
Chunk: 35

Company: Inmune Bio, Inc.
Filing Date: 2025-10-30
Form: 10-Q
Item: Part I, Item 1
Chunk 35
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 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.

25

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 approximately $0.3 million which
the Company paid during July 2025 and a single development milestone of approximately £6 million (approximately $8.1 million at
September 30, 2025) due on receipt of first marketing authorization from the FDA, EMA, or MHRA, which has not occurred yet, and an ongoing
commitment to supply CORDStrom to patients enrolled in an open label arm of the Mission EB trial, subject to certain limitations.

After
reviewing results of the Mission EB study, the Company initiated a Type C meeting with the FDA to obtain CMC and regulatory feedback and
submitted information, data and requests for Rare Pediatric Disease and Orphan Drug Designations (RP