Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 177

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 177
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 in the
timing of clinical trials, and is affected by many factors, including:

    ●
    the size and nature of the patient population;

    ●
    the severity of the disease under investigation;

    ●
    the proximity of patients to clinical sites;

    ●
    the eligibility criteria for the trial;

    ●
    the design of the clinical trial;

    ●
    efforts to facilitate timely enrollment;

    ●
    competing clinical trials; and

    ●
    clinicians’ and patients’ perceptions as to the potential advantages and risks of the drug being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating.

36

Our inability to enroll a
sufficient number of patients for our clinical trials could result in significant delays or may require us to abandon one or more clinical
trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our product candidates, delay
or halt the development of and approval processes for our product candidates and jeopardize our ability to achieve our clinical development
timeline and goals, including the dates by which we will commence, complete and receive results from clinical trials. Enrollment delays
may also delay or jeopardize our ability to commence sales and generate revenues from our product candidates. Any of the foregoing could
cause the value of the Company to decline and limit our ability to obtain additional financing, if needed.

We will need to obtain FDA approval of any
proposed product brand names, and any failure or delay associated with such approval may adversely impact our business.

A pharmaceutical product cannot
be marketed in the U.S. or other countries until we have completed rigorous and extensive regulatory review processes, including approval
of a brand name. Any brand names we intend to use 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