Company: INMB
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001213900-25-073077
Chunk: 65

Company: Inmune Bio, Inc.
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 2
Chunk 65
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 along with company resources, the treatment resistant depression trial will not be pursued. 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 marketing
authorization by filing a Marketing Authorization Application (MAA) in the United Kingdom followed by a Biologics License Application
(“BLA”) with the FDA in the US which is anticipated in the first half of 2026.

We believe our DN-TNF platform
can be used as a CNS (“central nervous system”) therapy to target glial activation to prevent progression of AD along with
other inflammatory diseases. The primary focus of the Company’s development efforts for XPro is AD. In each case, we believe neutralizing
sTNF is a cornerstone to the treatment of these diseases.

18

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 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 been completed. The open label, dose escalation trial was designed to demonstrate
that XPro can safely decrease neuroinflammation in patients with AD and biomarkers of inflammation (ADi). The goal of the Phase 1 trial
was to demonstrate safety in the target population (patients with AD), demonstrate target engagement by showing XPro got into the brain
in therapeutically relevant concentrations and reduced neuroinflammation) and identify the best dose for