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

Company: Inmune Bio, Inc.
Filing Date: 2025-10-30
Form: 10-Q
Item: Part I, Item 1
Chunk 30
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 sedimentation
rate (ESR > 10 mm/h), hemoglobin A1c (HbA1c > 6.0% DCCT), or at least one APOE4 allele. The primary endpoint was the Early
and Mild Alzheimer’s Cognitive Composite (EMACC), with secondary endpoints of Clinical Dementia Rating Scale – Sum of Boxes
(CDR-SB), Everyday Cognition Scale (E-Cog), Neuropsychiatric Inventory (NPI-12), ADCS-ADL, and biomarkers such as pTau-217 and GFAP. MRI-based
neuroinflammation and brain volumetrics are also evaluated. The AD program had sites in Australia, Canada, the United Kingdom, France,
Germany, Spain, Czech Republic and Slovakia.

Full enrollment in the Phase
II AD trial occurred in late 2024 with 208 patients enrolled and top-line data was received during June 2025. In the Phase 2 MINDFuL trial
of XPro™ in patients with early Alzheimer’s Disease (AD) with biomarkers of inflammation, the modified intent-to-treat
(mITT) population (n=200) did not meet the primary and key secondary endpoints (figure 1). Efficacy, Demographics and Safety data
are shown below.

Figure 1: Phase 2 Study Results – mITT population Primary
and Key Secondary Endpoints, Change From Baseline

Figure 1: As these graphs depict, the primary
and secondary endpoints in this trial were not met as no decline in the placebo groups were observed. A trend was observed in NPI that
favored XPro1595 over placebo. For reference, A higher EMACC score =better, A lower CDR and NPI score is better. EMACC: LS Mean Diff (SE):
-0.018 (0.0414), 90% CI: -0.0860, 0.0509, p-value: 0.672. CDR-SB: LS Mean Diff (SE): -0.11 (0.185), 90% CI: -0.417, 0.195, p-value: 0.5491.
NPI: LS Mean Diff (SE): -0.9 (0.78), 90% CI: -2.18, 0.39, p-value: 0.2499

Prespecified subgroups analyses
suggested a signal that favored XPro in a predetermined population