Company: INMB
Filing Date: 2025-05-08
Form Type: 10-Q
Source: 0001213900-25-041072
Chunk: 24

Company: Inmune Bio, Inc.
Filing Date: 2025-05-08
Form: 10-Q
Item: Part I, Item 1
Chunk 24
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 of inflammation (ADi). The ADi trial is a blinded randomized
trial to test if treatment of early AD patients with neuroinflammation with XPro will affect cognitive decline. Two hundred and eight
patients have been enrolled in a 2:1 ratio (XPro vs placebo). The patients received 1mg/kg/week as a subcutaneous injection for six months.
An enrichment strategy identical to the successful strategy used in the Phase I trial is used to ensure patients have neuroinflammation.
All patients 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 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. Data is expected to be reported during June. After all the data is 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 trial 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. To date, these funds have not been impacted by
any changes at the NIH. 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