Company: INMB
Filing Date: 2025-03-07
Form Type: 424B5
Source: 0001213900-25-021719
Chunk: 34

Company: Inmune Bio, Inc.
Filing Date: 2025-03-07
Form: 424B5
Chunk 34
---
 We expect to be eligible for
Break Through status after completion of the Phase II 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 received a $2.9M USD award from the National Institute
of Mental Health (“NIMH”) to treat TRD with XPro. 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 end-points include both clinical
and neuroimaging measures. The final trial design is ongoing and discussions with the FDA are not complete. The Company received authorization
to initiate a clinical trial in AD in the US during January 2024. The TRD trial is expected to start enrollment after the AD Phase II
trial finishes patient enrollment.

<div align='center'>2</div>

We believe that INKmune improves
the ability of the patient’s own NK cells to attack their tumor. INKmune interacts with the patient’s NK cells to convert
them from inert resting NK cells into memory-like NK cells that kill the patient’s cancer cells. INKmune is a replication incompetent
proprietary cell line that is given to the patient after determining that i) the patient has adequate NK cells in their circulation and
ii) those NK cells are functional when exposed to INKmune in vitro. INKmune is designed to be given to patients after their immune system
has recovered after cytotoxic chemotherapy to target the residual disease that remains after treatment with cytotoxic therapy. We believe
INKmune can be used to treat numerous hematologic malignancies and solid tumors including leukemia, multiple myeloma, lymphoma, lung,
ovary, breast, renal and prostate cancer. The Company had a Phase I trial using INKmune to treat patients with high risk MDS/AML, a form
of leukemia. Two patients were treated in the Phase I trial for MDS, three patients have been treated