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

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 10
---
 this group of patients includes at least 40% of patients with AD.
Patients have multiple biomarkers of neuroinflammation tested before and during therapy including soluble biomarkers in blood and cerebral
spinal fluid, behavioral biomarkers (neuropsychiatric symptoms of AD), EEG and neuroimaging biomarkers using MRI. The primary goal of
this short, open label study was to demonstrate that treatment with XPro decreases neuroinflammation safely and to define the dose of
XPro to use in the Phase II trial.

The Company has enrolled a
global blinded randomized Phase II trial in ADi patients with Early AD in Australia, Canada, the United Kingdom, Spain, France, Germany,
Poland, the Czech Republic, and Slovakia. Early AD is patients that have Mild Cognitive Impairment or mild AD. There is an Expanded Access
Scheme in patients who completed the Phase I trial in Australia that can request XPro of which two patients from the Phase I remain on
the drug as of this writing. The goal of the Phase II trial will be to demonstrate the prolonged control of neuroinflammation in patients
with dementia will help control cognitive decline.

5

The Phase I trial enrolled 18 patients at three
dose cohorts of 0.3, 0.6 and 1.0mg/kg given once a week as subcutaneous injection for three months. Patients in the 1.0mg/kg group were
offered extended use of the drug for up to 12 months. Three patients remained on XPro for 12 months. Preliminary data was presented in
a webinar on 13 July 2020. Additional data was presented on January 21, 2021CSF cytokine/chemokines were measured in 9 patients before
and after 12 weeks of weekly therapy with XPro using a panel from OLINK Target 48 Cytokine (Figure below).

In the 6 patients in the 1mg/kg
per week dose, only one cytokine and chemokine, interferon gamma (“INFg”) did not change in the CSF of patients, the remainder
all decreased on average of 15%. The data analyzed provides evidence that XPro decreases neuroinflammation in patients with Alzheimer’s
disease.

We believe these data support
the use of XPro to treat other diseases where neuroinflammation is a part of the pathophysiology of the disease. The company studied the
consequences of decreasing neuroinflammation