Company: INMB
Filing Date: 2025-03-07
Form Type: 424B5
Source: 0001213900-25-021719
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Company: Inmune Bio, Inc.
Filing Date: 2025-03-07
Form: 424B5
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Company 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 (“XPro”). 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.

XPro, targets AD and TRD. XPro for AD has completed
Phase I trials and a Phase II trial has completed enrollment of patients at clinical sites in, UK, 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. 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 by filing a
Biologics License Application (“BLA”) with the U.S. Food and Drug Administration (“FDA”) which is anticipated
by the end of 2025 or early 2026. Afterwards, the Company intends to file a Marketing Authorization Application (“MAA”) in
the UK and EU.

CORDStrom is a patent-pending
cell medicine comprising aseptic, allogeneic, pooled hucMSCs in suspension for injection or