Company: INMB
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001213900-25-073077
Chunk: 75

Company: Inmune Bio, Inc.
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 2
Chunk 75
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 each cohort as it becomes available. Because of the modified
Bayesian design, the Company estimates the trial will be completely enrolled Q425 with top-line data available 6 months later. 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 $34.2 million for the six months
ended June 30, 2025. As of June 30, 2025 and December 31, 2024, we had cash and cash equivalents of $33.4 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 our expenses and our ability to generate revenues, if any.

Our recurring net losses and
negative cash flows from operations raised substantial doubt regarding our ability to continue as a going concern within one year after
the issuance of our unaudited condensed consolidated financial statements for the six months ended June 30, 2025. Until we can generate
sufficient revenue from the commercialization of our product candidates, we expect to finance our operations through the public or private
sale of equity, debt financings or other capital sources, such as government funding, collaborations, strategic alliances, divestment
of non-core assets, or licensing arrangements with third parties. To date, the Company has relied on equity and debt financing to fund
its operations.

Other Developments

The new U.S. administration
has announced or imposed a series of tariffs on U.S. trading partners