Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 757

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 7
Chunk 757
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ITEM 7.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and
analysis of our financial condition and results of operations in conjunction with our financial statements and notes thereto appearing
elsewhere in this Annual Report. In addition to historical financial information, the following discussion and analysis contains forward-looking
statements that involve risks, uncertainties, and assumptions. Our actual results could differ materially from those anticipated by these
forward-looking statements as a result of many factors. We discuss factors that we believe could cause or contribute to these differences
below and elsewhere in this Form 10-K, including those set forth under “Risk Factors” and “Forward-Looking Statements.”

Overview

Our objective is to develop
and commercialize our product candidates to treat diseases where the innate immune system is dysfunctional causing or contributing to
the patient’s disease. Innate immune dysfunction can occur for a variety of reasons including genetics, lifestyle, and other factors.
However, age plays a significant role in the development of immune dysfunction. Innate immune dysfunction can be seen in cancer where
Natural Killer (“NK”) cells are impaired and facilitate a tumor’s evasion of the immune system and subsequent disease
progression. Chronic inflammation is implicated in neurologic and metabolic diseases where it impairs the innate immune system. Our primary
focus continues to be treatment of cancer with INKmune and treatment of Alzheimer’s Disease (“AD”) and Treatment Resistant
Depression (“TRD”) with XPro1595. We have added CORDStrom, a pooled, human umbilical cord mesenchymal stem cell product to
treat recessive dystrophic epidermolysis bullosa (RDEB), a pediatric orphan disease caused by mutations in the COL7A1 gene that results
in a debilitating disease of skin blistering, dysphagia and failure to thrive with chronic wound problems that often results in fatal
squamous cell carcinoma.

XPro1595 (“XPro”),
targets Alzheimer’s Disease and TRD. XPro for AD has completed Phase I trials and a Phase II trial has completed enrollment of patients
at clinical sites in the United Kingdom, EU, Australia and Canada. Patients are currently being treated with XPro for Early AD as part
of that clinical trial. TRD is being prepared for Phase II trials. We expect to start a pivotal global registration trial in patients
with AD after the results of the Phase II trial have been analyzed. The