Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 175

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 175
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 or

    ●
    be required to remove the product from the market after obtaining marketing approval.

If we experience any of a number of possible
unforeseen events in connection with clinical trials of any of our product candidates, potential marketing approval or commercialization
of that product candidate could be delayed or prevented.

We may experience numerous
unforeseen events during, or as a result of, clinical trials that could delay or prevent marketing approval of any of our product candidates,
including:

    ●
    clinical trials of our product candidate may produce unfavorable or inconclusive results;

    ●
    we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

    ●
    the number of patients required for clinical trials of our product candidate may be larger than we anticipate, patient enrollment in these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials at a higher rate than we anticipate;

    ●
    data safety monitoring committees may recommend suspension, termination or a clinical hold for various reasons, including concerns about patient safety;

    ●
    regulators or institutional review boards, or IRBs, may suspend or terminate the trial or impose a clinical hold for various reasons, including noncompliance with regulatory requirements or concerns about patient safety;

    ●
    patients with serious, life-threatening diseases included in our clinical trials may die or suffer other adverse medical events for reasons that may not be related to our product candidate;

    ●
    participating patients may be subject to unacceptable health risks;

    ●
    patients may not complete clinical trials due to safety issues, side effects, or other reasons;

    ●
    changes in regulatory requirements and guidance may occur, which require us to amend clinical trial protocols to reflect these changes;

    ●
    our third-party contractors, including those manufacturing our product candidate or components or ingredients thereof or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner or at all;

    ●
    regulators or IRBs may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

    ●
    we may experience delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;

    ●
    patients who enroll in a clinical trial may misrepresent their eligibility to do so or may otherwise not comply with the clinical trial protocol, resulting in the need to drop the patients from the clinical