Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 35

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 35
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 enrollment of the Phase
I/II trials. We may transfer the manufacturing to a different commercial contract manufacturing organization after completion of these
Phase II studies.

Human Mesenchymal Stem
Cells

In November 2017 (amended
in October 2022), we entered into a Material Transfer and License Agreement with the Anthony Nolan Cord Blood Bank (“AN”),
the oldest and largest non-directed cord blood bank in the United Kingdom for the supply the starting material for the mesenchymal stem
cells - umbilical cords not used after cord blood harvest. Mark Lowdell’s research group developed and validated a methodology for
producing large numbers of clinical-grade pooled HucMSC. We believe we are well positioned to become a preferred manufacturing partner
for companies who need MSC for clinical programs. Manufacture of HucMSC is performed under the direction of Mark Lowdell in a licensed
GMP facility that is contracted to the Company as part of existing research and development agreements. The starting material for the
HucMSC product is provided by the AN. The HucMSC product produced in this facility are fully qualified to be used for either research
or clinical trials. We have developed a validated manufacturing process that reliably produces contract manufacturer of the clinical grade
(“cGMP”) quality mesenchymal stem cells that we call CORDStrom. To date, we are supporting one academic clinical trial with
CORDStrom in the United Kingdom treating children with recessive dystrophic erythematous bullosa (“RDEB”), a disfiguring skin
disease in children that is similar to a second-degree burn. INmune Bio supplied the clinical product for treatment of these patients.
The pivotal trial in RDEB has been completed. The Company reviewed the clinical data under CDA on October 7, 2024. A non-binding agreement
was executed with GOSH while the company determined if the clinical data could be used to support marketing authorization of CORDStrom
to treat RDEB in the US. The Company completed that review and licensed the clinical data from GOSH on February 6, 2025. The use of CORDStrom
to treat children with RDEB was announced publicly on February 10, 2025. Currently, we plan to supply CORDStrom to third parties for their
research use and in clinical trials as part of the development process for commercial products. We may decide to expand this agreement
in the future if the