Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 179

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 179
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    the clinical indications for which the product is approved;

    ●
    whether the product is designated under physician treatment guidelines as a first-line therapy or as a second- or third-line therapy;

    ●
    limitations or warnings, including distribution or use restrictions, contained in the product’s approved labeling;

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    our ability to offer the product for sale at competitive prices;

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    our ability to establish and maintain pricing sufficient to realize a meaningful return on our investment;

    ●
    the product’s convenience and ease of administration compared to alternative treatments;

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    ●
    the willingness of the target patient population to try, and of physicians to prescribe, the product;

    ●
    the strength of sales, marketing and distribution support;

    ●
    the approval of other new products for the same indications;

    ●
    changes in the standard of care for the targeted indications for the product;

    ●
    the timing of market introduction of our approved products as well as competitive products and other therapies;

    ●
    availability and amount of reimbursement from government payors, managed care plans and other third-party payors;

    ●
    adverse publicity about the product or favorable publicity about competitive products; and

    ●
    potential product liability claims.

The potential market opportunities
for our product candidate are difficult to estimate precisely. Our estimates of the potential market opportunities are predicated on many
assumptions, including industry knowledge and publications, third-party research reports and other surveys. While we believe that our
internal assumptions are reasonable, these assumptions involve the exercise of significant judgment on the part of our management, are
inherently uncertain and the reasonableness of these assumptions has not been assessed by an independent source. If any of the assumptions
prove to be inaccurate, the actual markets for our product candidate could be smaller than our estimates of the potential market opportunities.

Even if we obtain regulatory approvals for
CORDStrom, INKmune and/or any product from our DN-TNF platform those approvals and ongoing regulation of our products may limit how we
manufacture and market our products, which could prevent us from realizing the full benefit of our efforts.

If we obtain regulatory approvals,
CORDStrom, INKmune and/or the DN-TNF product platform, and the manufacturing facilities used for its production will be subject to continual
review, including periodic inspections, by the FDA and other United States and foreign regulatory authorities. In addition, regulatory
authorities may impose significant restrictions on