Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 178

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 178
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 identify a suitable product brand name that would qualify under applicable trademark laws, not infringe
the existing rights of third parties and be acceptable to the FDA. We may be unable to build a successful brand identity for a new trademark
in a timely manner or at all, which would limit our ability to commercialize our product candidates.

37

We may fail to comply with regulatory requirements.

Our success will be dependent
upon our ability, and our collaborative partners’ abilities, to maintain compliance with regulatory requirements, including cGMP,
and safety reporting obligations. The failure to comply with applicable regulatory requirements can result in, among other things, fines,
injunctions, civil penalties, total or partial suspension of regulatory approvals, refusal to approve pending applications, recalls or
seizures of products, operating and production restrictions and criminal prosecutions.

Even if our product candidates receive marketing
approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical
community necessary for commercial success and the market opportunity for the product candidates may be smaller than we estimate.

We have never commercialized
a product. Even if CORDStrom, INKmune, our DN-TNF product platform (INB03 or XPro), or any other product candidate we develop is approved
by the appropriate regulatory authorities for marketing and sale, it may nonetheless fail to gain sufficient market acceptance by physicians,
patients, third-party payors and others in the medical community. For example, physicians are often reluctant to switch their patients
from existing therapies even when new and potentially more effective or convenient treatments enter the market. Further, patients often
acclimate to the therapy that they are currently taking and do not want to switch unless their physicians recommend switching products
or 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;

    ●