Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 61

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 61
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 the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even
after achieving encouraging results in earlier studies. Any such setbacks in our clinical development could materially harm our business,
results of operations, financial condition and prospects.

Interim top-line
and preliminary data from our planned clinical trials that we announce or publish from time to time may change as more patient data become
available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we may
publish interim top-line or preliminary data from our planned clinical trials. Interim data from clinical trials that we may complete
are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient
data becomes available. Preliminary or top-line data also remain subject to audit and verification procedures that may result in the final
data being materially different from the preliminary data we previously published. As a result, interim and preliminary data should be
viewed with caution until the final data is available. Adverse differences between preliminary or interim data and final data could significantly
harm our reputation and business prospects.

If clinical trials of our product candidates
fail to demonstrate safety and efficacy to the satisfaction of the FDA and comparable non-U.S. regulators, we may incur additional costs
or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

We are not permitted to commercialize,
market, promote or sell any product candidate in the United States without obtaining marketing approval from the FDA. Comparable non-U.S.
regulatory authorities, such as the EMA, impose similar restrictions. We may never receive such approvals. We must complete extensive
preclinical development and clinical trials to demonstrate the safety and efficacy of our product candidate in humans before we will be
able to obtain these approvals.

Clinical testing is expensive,
difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome. We have not previously submitted
an NDA to the FDA or similar drug approval filings to comparable non-U.S. regulatory authorities for any product candidate.

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Any inability to successfully
complete preclinical and clinical development could result in additional costs to us and impair our ability to generate revenues from
product sales, regulatory and commercialization milestones and royalties. In addition, if (1) we are required to conduct additional clinical
trials or other testing of our product candidate beyond the trials and testing than we contemplate, (2) we are unable