Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 351

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1C
Chunk 351
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 The primary end-point will be Early/mild Alzheimer’s Cognitive Composite (“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.

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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.

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 TNF and anti-TNF therapeutics was explored
in a small open label clinical trial by Prof. Andrew Miller, MD of Emory University demonstrated the patients have elevated TNF levels
and treatment with infliximab treated their depression (Miller, 2011). The Company has a $2.0M USD award from the National Institute of
Mental Health (“NIMH”) to treat TRD with XPro. The blinded, randomized Phase II trial will use biomarkers of peripheral inflammation
to select patients with TRD for enrollment. Patients will be treated for 6 weeks. Primary end-points include both clinical and neuroimaging
measures. The TRD trial is expected to start enrollment during 2025.

We believe that INKmune improves
the ability of the patient’s own NK cells to attack their tumor. INKmune interacts with the patient’s NK cells to convert
them from inert resting NK cells into memory-like NK cells that kill the patient’s cancer cells. INKmune is a replication incompetent
proprietary cell line that is given to the patient after determining that i) the patient has adequate NK cells in their circulation and
ii) those