Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 66

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 66
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 they are required to switch therapies due to lack of reimbursement for existing therapies.

Efforts to educate the medical
community and third-party payors on the benefits of our product candidate may require significant resources and may not be successful.
If our product candidate is approved but does not achieve an adequate level of market acceptance, we may not generate significant revenues
and we may not become profitable. The degree of market acceptance of INmune or any other product candidate we develop, if approved for
commercial sale, will depend on a number of factors, including:

    ●
    the efficacy and safety of the product;

    ●
    the potential advantages of the product compared to alternative treatments;

    ●
    the prevalence and severity of any side effects;

    ●
    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;

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

    ●
    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