Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 622

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 5
Chunk 622
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 off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced at
low cost and with repeatable specification independent of donor characteristics. Initially developed at the INKmune manufacturing facilities
utilizing United Kingdom academic grant funding, CORDStrom is a product platform that shows promise as a therapy for RDEB and many other
debilitating conditions. While the first generation CORDStrom product is agnostic to indication, the platform enables creation of indication-specific
products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.

The
CORDStrom product 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