Company: INMB
Filing Date: 2025-05-08
Form Type: 10-Q
Source: 0001213900-25-041072
Chunk: 53

Company: Inmune Bio, Inc.
Filing Date: 2025-05-08
Form: 10-Q
Item: Part I, Item 2
Chunk 53
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 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/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 $9.7 million for the three months ended March 31, 2025. As of March 31, 2025 and December 31, 2024, we had cash and cash equivalents
of $19.3 million and $20.9 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