Company: INMB
Filing Date: 2025-03-07
Form Type: 424B5
Source: 0001213900-25-021719
Chunk: 11

Company: Inmune Bio, Inc.
Filing Date: 2025-03-07
Form: 424B5
Chunk 11
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F 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 has a $2.0 million 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 TRD
trial is expected to start enrollment during 2025.

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 compassionately in AML and another MDS patient
is expected to be treated shortly. During March 2024, the Company decided to terminate further enrollment in the MDS/AML trial. In the
patients, INKmune therapy is safe, produces memory-like NK cells that kill cancer in vitro, and promotes development of cancer killing
memory-like NK cells that can be found in the patient’s circulation of 4 months. The Company initiated a separate Phase I/II trial
of INKmune in a metastatic castrate resistant prostate cancer. The open label trial enrolled the first patient in December 2023.

The Phase I/II