Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 277

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1B
Chunk 277
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 dystrophic epidermolysis bullosa (RDEB), a pediatric orphan disease caused by mutations in the COL7A1 gene that results
in a debilitating disease of skin blistering, dysphagia and failure to thrive with chronic wound problems that often results in fatal
squamous cell carcinoma.

XPro1595 (“XPro”),
targets Alzheimer’s Disease and TRD. XPro for AD has completed Phase I trials and a Phase II trial has completed enrollment of patients
at clinical sites in the United Kingdom, EU, Australia and Canada. Patients are currently being treated with XPro for Early AD as part
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, immunom