Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 347

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1C
Chunk 347
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 platform shares many similarities, including starting materials, equipment, and procedures, with the Company’s
INKmune oncology product, enabling the Company to leverage economies of scale, experienced staff, and other resources to strategically
manufacture both products in a rotational campaign with resource and environmental efficiencies.

Children with Recessive Dystrophic Epidermolysis Bullosa (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