Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 12

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 12
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 EEG and MRI DTI will be used in some or all patients. Top line cognitive data,
EMACC, will be presented around June of 2025. All additional cognitive, functional, neuroimaging and biomarker data will be presented
approximately 8 weeks later.

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 whereby it was demonstrated that patients which have
elevated TNF levels responded to treatment with infliximab (Miller, 2011).

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 endpoints include both clinical and neuroimaging measures.

XPro, is delivered as a subcutaneous
injection, similar to an insulin treatment or anti-obesity GLP-1 drugs, is given once a week. More frequent treatment cannot be ruled
out for future indications. Because this is a simple subcutaneous injection similar to an insulin injection (the therapy patients give
themselves for treatment of Type 1 diabetes mellitus), we expect patients to administer the therapy by themselves or caregivers and not
require expensive or logistically challenging clinic visits to receive the therapy.

7

Release of XPro drug supply

GMP DN-TNF product (XPro)
used in the oncology Phase I, AD Phase I and COVID-19 Phase II trial were manufactured by Lonza at a site in New Hampshire. The supply
of Lonza DN-TNF product is limited but allowed completion of the Phase I study in Alzheimer’s disease and support of patients in
the extension study for 12 months. New batches of XPro have been produced for ongoing clinical trials. The Company engaged KBI Biopharma
to manufacture 6 lots of XPro at the Boulder, Colorado facility using the original master cell bank and updated manufacturing process.
One lot has been converted into drug product using the US fill/finish facility of Vetter Pharma. Half of the first lot is frozen as drug
substance at -80C with a plan to convert to drug product as clinical supplies are needed to support the AD and TR