Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 11

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 11
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 in the 6 patients from target dose group (XPro 1mg/kg for 12 weeks) be looking at the CSF
proteome using technology for Proteome Sciences using their TMT Calibrator™ platform. A large data set of proteins were identified.
Early analysis of the data focusing on 26 AD related proteins demonstrated changes in inflammation, neuronal and synaptic proteins caused
by decreasing neuroinflammation after treatment with XPro (Figure below). The proteome also demonstrated a clear dose response with a
greater number of proteins being affected by the target dose compared to low dose XPro therapy (0.3 vs 1.0 mg/kg/week for 12 weeks) (Figure
below). The CSF proteome data is only partially analyzed. Additional data may result from these ongoing analytics.

6

The results of the Phase I
study demonstrated that XPro safely decreases neuroinflammation in patients with AD and elevated neuroinflammation with biomarkers of
peripheral inflammation or are ApoE4 positive when given for at least 3 months at the 1mg/kg once a week dose. Decreasing neuroinflammation
with XPro appears to decrease neurodegeneration and improve synaptic function and promote remyelination. The effect of XPro on the biology
and immunology of the brain in patients with AD suggest XPro therapy in patients with peripheral biomarkers of inflammation or ApoE4 allele(s)
may impact cognitive decline. Although there were anecdotes of improved cognitive function in patients receiving the target dose of XPro,
this cannot be verified because the trial was not a blinded, randomized trial. The impact on cognition of controlling neuroinflammation
with XPro will be studied in the Phase II program which is a blinded randomized, placebo controlled clinical trial.

AD02 is the ongoing blinded
randomized global Phase II trial in patients with early AD enrolled 208 patients in a 2:1 ratio (XPro:placebo) at 1mg/kg once a week.
The trial enrolled the last patient in November 2024. Patients are treated for 6 months of therapy. The primary end-point is Early/Mild
Alzheimer’s Cognitive Composite (“EMACC”), a sensitive cognitive end-point validated for use in patients with early
AD. Secondary cognitive (CDR-SB and NPI) and functional (GAS, ADCS-ADL) end-points will be measured. Exploratory structural and function
biomarkers of brain function and structural integrity using