Company: INMB
Filing Date: 2025-10-30
Form Type: 10-Q
Source: 0001213900-25-104141
Chunk: 37

Company: Inmune Bio, Inc.
Filing Date: 2025-10-30
Form: 10-Q
Item: Part I, Item 1
Chunk 37
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/AML trial in March 2024. Nonetheless, from the four patients
treated and completing follow-up it was determined that INKmune therapy is safe and promotes development of cancer killing memory-like
NK cells that are activated and can kill NK-resistant cancer cells which can be found in the patient’s circulation for up to 4 months
after completion of treatment. The Company initiated a separate multicenter Phase I/II trial of INKmune in a metastatic castrate resistant
prostate cancer in the US. The open label trial enrolled the first patient in December 2023 and is currently in Phase II across 6 US sites. 

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 plans to report data from each cohort as it becomes available. Because of the modified
Bayesian design, the Company estimates the trial will be completely enrolled during the fourth quarter of 2025 with top-line data anticipated
approximately 6 months thereafter. Topline data are divided into immunologic and tumor response variables. The most important immunologic
response variable is related to memory-like NK cell persistence. There are 3 important variables to tumor response: i) blood PSA changes;
ii) change in PSMA-PET scan and iii) change in circulating tumor DNA (ctDNA). INKmune is not a hormone-targeting treatment and will not
directly reduce PSA levels but tumor load measured by PSMA-PET and/or ctDNA are expected to 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 $40.7 million for the nine months ended September 30, 2025. As of September 30, 2025 and December 31, 2024, we had cash and
cash equivalents of $27.7 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