Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 21

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 21
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 the functional activity of NK cells from MDS patients
can be enhanced by exposure to INKmune. Moreover, INKmune-primed NK cells are not inhibited by the hypoxic conditions of the diseased
bone marrow microenvironment.

The first patient was treated in the second quarter of 2021. The patient,
part of the first cohort, received 1x10^8 INKmune cells on day 1,8 and 15 as an in-patient. The patient did not require any type of conditioning
therapy or cytokine support. The patient tolerated the three infusions without any problems. The patient underwent intensive monitoring
over 120 days. There are 4 observations from this first patient. The patient has dramatically increased the number of activated, “memory-like”
NK cells in circulation. Memory-like NK cells (mlNK) are activated NK cells with a unique cell surface protein phenotype and which show
enhanced lysis of tumor cell in vitro. Post treatment with INKmune, elevated levels of mlNK cells were present in the patients in the
peripheral blood for more than 119 days when trial follow-up ceased. The patient mlNK actively kill NK resistant cancer targets in vitro.
Finally, the patient had a significant clinical improvement with a reduction of his ECOG score from 2 to 0 and a significant reduction
in blood product support.

Three compassionate use cases have also been treated. Two were young patients
with AML who had failed previous hematopoietic stem cell transplants (“HSCT”). The first compassionate-treatment patient showed
such improved neutrophil and platelet counts that she was discharged from hospital for the first time in six months. The second patient
treated compassionately had failed two high risk HSCT and entered the course of INKmune therapy with high percentage of blasts in his
bone marrow. His blood NK cells responded in differentiation into mlNK as hoped but it is too early to determine if INKmune has provide
any clinical benefit. Due to market opportunities, the Company closed the high-risk MDS trial to focus on solid tumors. The Company plans
to put all of its INKmune development efforts into the on-going US Phase I/II trial in men with mCRPC.

13

INKmune Registration Studies and/or Partnering

During March 2023 the Company
opened an Investigational New Drug (“IND”) application for a Phase I/II trial of INKmune in m