Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 64

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 64
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ize
our product candidates and may harm our business and results of operations. In addition, many of the factors that cause, or lead to, clinical
trial delays may ultimately lead to the denial of marketing approval of our product candidates.

If we experience delays or difficulties
in the enrollment of patients in clinical trials, we may not achieve our clinical development on our anticipated timeline, or at all,
and our receipt of necessary regulatory approvals could be delayed or prevented.

We may not be able to initiate
or continue clinical trials for CORDStrom, INKmune our DN-TNF product platform or any other product candidate if we are unable to locate
and enroll a sufficient number of eligible patients to participate in clinical trials. Patient enrollment is a significant factor 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