Company: INMB
Filing Date: 2025-05-08
Form Type: 10-Q
Source: 0001213900-25-041072
Chunk: 47

Company: Inmune Bio, Inc.
Filing Date: 2025-05-08
Form: 10-Q
Item: Part I, Item 2
Chunk 47
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, 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
(“mCRP”C). 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 the first half of 2026. Afterwards, the company intends to file a Marketing Authorization Application (MAA)
in the United Kingdom and EU.

17

We believe our DN-TNF
platform can be used as a CNS (“central nervous system”) therapy to target glial activation to prevent progression of Alzheimer’s
disease (“AD”); to target neuroinflammation in treatment resistant depression (“TRD”). The primary focus of the
company’s development efforts for XPro is AD. The next indication to be developed with XPro will be TRD. In each case, we believe
neutralizing sTNF is a cornerstone to the treatment of these diseases.

We believe the DN-TNF platform
can be used to treat selected neurodegenerative diseases by reducing neuroinflammation without immunosuppression. The Company believes
the core pathology of cognitive decline is a combination of neurodegeneration and synaptic dysfunction. Neurodegeneration is nerve cell
death that may include demyelination. Synaptic dysfunction means the connections between nerve cells stop working efficiently and may
decrease in number. The combination of neurodegeneration and synaptic dysfunction causes cognitive decline and behavioral changes associated
with Alzheimer’s disease (“AD”). XPro completed a Phase I trial treating patients with Alzheimer’s disease that
was partially funded by a Part-the-Clouds Award from the Alzheimer’s Association. We believe XPro targets activated microglia and
astrocytes of the brain that produce sTNF that promotes nerve cell loss, synaptic dysfunction and prevents myelin repair - key elements
in the development of dementia. In animal models, elimination of sTNF prevents nerve cell dysfunction, reverses synaptic pruning and promotes
myelin repair. The Phase I trial in patients with biomarkers of inflammation with AD has