Company: INMB
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001213900-25-073077
Chunk: 34

Company: Inmune Bio, Inc.
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 1
Chunk 34
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 with resource and environmental efficiencies.

Children
with RDEB have skin that is damaged by even the smallest amount of friction which causes severe blistering, deep wounds, and scars. It
is caused by a fault in a gene that makes collagen, a protein that holds the skin layers together. There are limited options available
for treatment, none that adequately meet the needs of patients, and the condition gets worse over time with most children reliant on a
wheelchair as they move into their teenage years. Many of those with an RDEB diagnosis will also go on to develop aggressive life-threatening
skin cancer in adulthood caused by the accumulated damage to their skin. The Company estimates roughly 2,000 people suffer from RDEB
in the US, United Kingdom and EU representing a large unmet opportunity to potentially provide routine clinical care to these children.

Since
2020, the Company has supplied CORDStrom HucMSCs as an investigational medical product to the 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