Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 95

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 95
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of that clinical trial. TRD is being prepared for Phase II trials. We expect to start a pivotal global registration trial in patients
with AD after the results of the Phase II trial have been analyzed. The INKmune program is in an open label Phase II trial in metastatic
castrate resistant prostate cancer (mCRPC). CORDStrom for the treatment of children with RDEB has completed a pivotal blinded randomized
cross-over trial. The data will be submitted for a marketing authorization by filing a Biologics License Application (BLA) with the FDA
in the US which is anticipated in late 2025 or early 2026. Afterwards, the company intends to file a Marketing Authorization Application
(MAA) in the United Kingdom and EU.

55

CORDStrom,
developed by INmune Bio circa 2020, represents a breakthrough in mesenchymal stem cell technology. The CORDStrom platform leverages, among
other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled human umbilical cord
-derived mesenchymal stromal cells (HucMSCs) as medicines to treat complex inflammatory diseases. CORDStrom products are designed to provide
high-quality, 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