Company: INMB
Filing Date: 2025-10-30
Form Type: 10-Q
Source: 0001213900-25-104141
Chunk: 28

Company: Inmune Bio, Inc.
Filing Date: 2025-10-30
Form: 10-Q
Item: Part I, Item 1
Chunk 28
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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 2026.

We believe our XPro™
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 neuroinflammation and immune dysfunction in these diseases.

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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 cease to work 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 phase 2. XPro got into the brain
(Figure 1a) and dose dependently decreased biomarker of neuroinflammation in the CSF (Figure 1b) with patients treated