Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
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Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
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Item 1. Business

Our Strategy

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 initial
focus continue to be treatment of cancer with INKmune and Alzheimer’s Disease (“AD”) and Treatment Resistant Depression
(“TRD”) with XPro1595. We have added CORDStrom, a pooled, human umbilical cord mesenchymal stem cell (“HucMSC”)
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 INKmune program is in an open label Phase II trial in metastatic
castrate resistant prostate cancer (“mCRPC”). CORDStrom for the treatment of children with RDEB has completed a pivotal blinded
randomized cross-over trial. The data will be submitted for a marketing authorization (“BLA”) in the US in the next 12-18
months.

The overall principal components
of our business strategy to achieve these objectives are to:

    ●
    Pursue a registration strategy for CORDStrom in RDEB that maximizes the value of the therapy and expand the CORDStrom platform;

    ●
    Pursue development strategies and regulatory approval