Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 174

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 174
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 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.

34

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 to successfully
complete clinical trials of our product candidate or other testing, (3) the results of these trials or tests are unfavorable, uncertain
or are only modestly favorable, or (4) there are unacceptable safety concerns associated with our product candidate, we, in addition to
incurring additional costs, may:

    ●
    be delayed in obtaining marketing approval for our product candidate;

    ●
    not obtain marketing approval at all;

    ●
    obtain approval for indications or patient populations that are not as broad as we intended or desired;

    ●
    obtain approval with labeling that includes significant use or distribution restrictions or significant safety warnings, including boxed warnings;

    ●
    be subject to additional post-marketing testing or other requirements;