Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 69

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 69
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 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;

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    ●
    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;

    ●
    refusal to approve pending applications or supplements to approved applications that we submit;

    ●
    recall of products, fines, restitution or disgorgement of profits or revenue;

    ●
    suspension, revocation or withdrawal of marketing approvals;

    ●
    refusal to permit the import or export of our products; and

    ●
    injunctions or the imposition of civil or criminal penalties.

We currently have no marketing and sales
organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into
agreements with third parties to market and sell our product candidates, we may not be able to generate product revenue.

We currently have no sales,
marketing or distribution capabilities and have no experience as a company in marketing products. If we develop internal sales, marketing
and distribution organization, this will require significant capital expenditures, management resources and time, and we would have to
compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel.

If we are unable or decide
not to establish internal sales, marketing and distribution capabilities, we expect to pursue collaborative arrangements regarding the
sales, marketing and distribution of our products. However, we may not be able to establish or maintain such collaborative arrangements,
or if we are able to do so, their sales forces may not be successful in marketing our products. Any revenue we receive would depend upon
the efforts of such third parties, which may not be successful. We may have little or no control over the sales, marketing and distribution
efforts of such third parties and our revenue from product sales may be lower than if we had commercialized our product candidates ourselves.
We also face competition in our search for third parties to assist us with the