Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 764

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 7
Chunk 764
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 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/2 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 trial using
INKmune to treat patients with metastatic castrate resistant prostate cancer (mCPRC) is an open label trial. Biomarker data from the patients
will be visible as patients are treated. The Company will report data from each cohort as it becomes available. Because of the modified
Bayesian design, the Company estimates the trial will be completely enrolled 1H25 with top-line data available 6 months later. Topline
data is divided into immunologic and tumor response variables. The most important immunologic response variable is related to memory like
NK cell persistence. This is how long are the number of mlNK cells in patients blood compared to baseline. There are 3 important variables
to tumor response: i) blood PSA changes; ii) change in PMSA scan and iii) change in circulating tumor DNA (ctDNA). Ideally, the levels
of all three variables decrease with treatment. We do not expect this 6 month trial to provide survival data.

We continue to incur significant
development and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred
losses in each period since our inception, resulting in substantial doubt in our ability to continue as a going concern. We reported a
net loss of $42.1 million and $30.0 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024 and
2023, we had cash and cash equivalents of $20.9 million and $35.8 million, respectively. We expect to continue to incur significant losses
for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek regulatory
approvals for, our product candidates. The size of our future net losses will depend, in part, on the rate of future growth of our expenses