Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 182

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 182
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    refusal to approve pending applications or supplements to approved applications that we submit;

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

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    suspension, revocation or withdrawal of marketing approvals;

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

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    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 sales, marketing and distribution efforts of our product
candidates. There can be no assurance that we will be able to develop internal sales, marketing distribution capabilities or establish
or maintain relationships with third-party collaborators to commercialize any product in the United States or overseas.

We face substantial competition from other
pharmaceutical and biotechnology companies and our operating results may suffer if we fail to compete effectively.

The development and commercialization
of new drug products is highly competitive. We expect that we will face significant competition from major pharmaceutical companies, specialty
pharmaceutical companies and biotechnology companies worldwide with respect to our DN-TNF product platform, INKmune and any other of our
product candidates that we may seek to develop or commercialize in the future.