Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 65

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 65
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 for our product candidates will require approval from the FDA regardless of whether
we have secured a formal trademark registration from the U.S. Patent and Trademark Office, or the USPTO. The FDA typically conducts a
review of proposed product brand names, including an evaluation of potential for confusion with other product names. The FDA may also
object to a product brand name if it believes the name inappropriately implies medical claims. If the FDA objects to any of our proposed
product brand names, we may be required to adopt an alternative brand name for our product candidates. If we adopt an alternative brand
name, we will lose the benefit of our existing trademark applications for such product candidate and may be required to expend significant
additional resources in an effort to 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