Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 181

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 181
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 be required to recall the drug or change the way the drug is administered;

    ●
    additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular drug;

    ●
    we may be subject to fines, injunctions or the imposition of civil or criminal penalties;

    ●
    regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication;

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    we may be required to create a Medication Guide outlining the risks of the previously unidentified side effects for distribution to patients;

    ●
    we could be sued and held liable for harm caused to patients;

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    the drug may become less competitive; and

    ●
    our reputation may suffer.

Any of these events could
have a material and adverse effect on our operations and business.

Any product candidate for which we obtain
marketing approval, along with the manufacturing processes, qualification testing, post-approval clinical data, labeling and promotional
activities for such product, will be subject to continual and additional requirements of the FDA and other regulatory authorities.

These requirements include
submissions of safety and other post-marketing information, reports, registration and listing requirements, good manufacturing practices,
or GMP requirements relating to quality control, quality assurance and corresponding maintenance of records and documents, and recordkeeping.
Even if marketing approval of our product candidate is granted, the approval may be subject to limitations on the indicated uses for which
the product may be marketed or to conditions of approval or contain requirements for costly post-marketing testing and surveillance to
monitor the safety or efficacy of the product. The FDA closely regulates the post-approval marketing and promotion of pharmaceutical products
to ensure such products are marketed only for the approved indications and in accordance with the provisions of the approved labeling.

In addition, later discovery
of previously unknown problems with our products, manufacturing processes, or failure to comply with regulatory requirements, may lead
to various adverse results, including:

    ●
    restrictions on such products, manufacturers or manufacturing processes;

    ●
    restrictions on the labeling or marketing of a product;

    ●
    restrictions on product distribution or use;

40

    ●
    requirements to conduct post-marketing clinical trials;

    ●
    requirements to institute a risk evaluation mitigation strategy, or REMS, to monitor safety of the product post-approval;

    ●
    warning letters issued by the FDA or other regulatory authorities;

    ●
    withdrawal of the products from the market;