Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 3

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 3
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iver and medical support. Available therapies for the diseases focus on wound closure. Itch, a clinical
symptom that occurs in all children with RDEB, is considered by patients to be the most important symptom with no therapy. CORDStrom decreases
itch considerably and safely, improves quality of life and may improve wound healing.

Collaborate to maximize
the value of our technology. We believe there are two reasons for us to enter collaborations with other companies. The first is the
further development of INKmune, XPro and CORDStrom by either providing additional innovations to the product, including combination therapy
strategies, and/or providing resources to improve the speed and breadth of the development process. The second is to optimize the commercialization
of our products either globally or regionally. The ideal partner will benefit us in both ways.

We have leveraged our unique
capabilities to optimize clinical application of cell medicines by developing CORDStrom for the treatment of RDEB. We believe that we
have developed a way to manufacture human mesenchymal stromal cells for the medical research and biotech community that offers large
volumes of high-quality, human umbilical cord mesenchymal stromal cells with minimal batch-to-batch variability. We have established
a reliable supply of human umbilical cords based on our agreement with the Anthony Nolan Cord Blood Bank in the United Kingdom and plan
to seek additional supplies from US sources in the future. We have developed a validated manufacturing process that reliably produces
clinical grade (“cGMP”) quality mesenchymal stromal cells that we call CORDStrom. The manufacturing process is currently
performed by INmune Bio staff at a contract manufacturing site under the direction of Mark Lowdell, the Company’s CSO. We supplied
CORDStrom for a multicenter academic clinical trial in in children with RDEB. This pivotal trial was sponsored by the Great Ormond Street
Children’s Hospital (“GOSH”) in London treating children with intermediate and severe- RDEB. The results of the pivotal
trial show that CORDStrom therapy decreases itch and pain and improves clinical scores in patients with RDEB. We have entered an exclusive
global license with GOSH for the clinical data. The Company plans to combine the clinical data and manufacturing process into a regulatory
dossier that seeks marketing authorization in the US via a BLA and in the United Kingdom and EU by MAA in