Company: INMB
Filing Date: 2025-03-07
Form Type: 424B5
Source: 0001213900-25-021719
Chunk: 10

Company: Inmune Bio, Inc.
Filing Date: 2025-03-07
Form: 424B5
Chunk 10
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 randomized, placebo-controlled Phase II trial in patients with early ADi. Early ADi includes
patients with AD and mild cognitive impairment (“MCI”) who have at least one biomarker of inflammation (ADi and MCI respectively).
The early ADi trial is a blinded randomized trial to test if treatment of early AD patients with neuroinflammation with XPro will affect
cognitive decline. The Phase II trial in early ADi has six important elements. 201 patients are being enrolled in a 2:1 ratio (XPro vs
placebo). The patients will receive 1mg/kg/week as a subcutaneous injection for six months. An enrichment strategy identical to the successful
strategy used in the Phase I trial will be used to ensure patients have neuroinflammation. Patients will need to have one or more enrichment
criteria: elevated blood level of at least one of C-reactive protein, hemoglobin A1c, erythrocyte sedimentation and at least one allele
of ApoE4. The primary end-point will be EMACC, a validated cognitive measure that is more sensitive than traditional end-points used in
many studies of patients with early AD. The AD program is open in Australia, Canada, the United Kingdom, France, Germany, Spain, Czech
Republic and Slovakia. All patients will be offered to stay on therapy for at least 12 months in an extension trial. Clinical and biomarker
data will be collected during the extension trial.

Full enrollment in the Phase II AD trial occurred
in late 2024 with 208 patients enrolled. Topline data of EMACC is expected to be reported in June followed by secondary end-points which
include blood biomarker, neuroimaging and additional neuropsychiatric end-points which should be available 2-3 months after top line data.
Finally, several months after all the data are analyzed, the Company plans an end-of-phase II meeting with the FDA to finalize plans for
the pivotal Phase III trial. XPro for treatment of AD may be eligible for one or both accelerated approval pathways. We expect to be eligible
for “Break Through” status after completion of the Phase II in 2025.

<div align='center'>S-3</div>

Effective therapy for TRD is a large unmet need.
Twenty percent of patients with a major depressive disorder have TRD. Once third of TRD patients have peripheral biomarkers to inflammation
(elevated CRP). This is a large patient population. The role of TN