Company: INMB
Filing Date: 2025-03-07
Form Type: 424B5
Source: 0001213900-25-021719
Chunk: 9

Company: Inmune Bio, Inc.
Filing Date: 2025-03-07
Form: 424B5
Chunk 9
---
generative 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 AD 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 ADi.
ADi is the term used to delineate patients with AD with biomarkers of inflammation. The endpoints of the trial were measures of neuroinflammation
and neurodegeneration in blood and cerebral spinal fluid by measuring changes in inflammatory cytokine levels in the CNS and using MRI-DTI
to measure brain microstructural changes. XPro, at the 1mg/kg/week dose, decreased inflammatory cytokines in the cerebrospinal fluid (“CSF”)
in the brain demonstrating that XPro can decrease neuroinflammation in patients with AD. We also studied downstream benefits of decreasing
neuroinflammation by measuring changes in the CSF proteome and quantifying changes in novel white matter MRI biomarkers. XPro significantly
decreases biomarkers of neurodegeneration as measured by changes in the CSF proteome including neurofilament light chain, phospho
Tau 217 and VILIP-1; decreases of 84%, 46% and 91% respectively after 3 months of therapy. Three months of XPro therapy improved measures
of synaptic function, as measured in the CSF proteome including a 222% increase in Contactin 2 and a 56% decrease neurogranin, changes
that contribute to improved synaptic function.

The successful completion of the Phase I trial
in AD has informed the design of a blinded