Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 176

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 176
---
 trial, increase the needed enrollment size for the clinical trial or extend the clinical trial’s duration;

    ●
    we may have to suspend or terminate clinical trials of our product candidate for various reasons, including a finding that the participants are being exposed to unacceptable health risks, undesirable side effects or other unexpected characteristics of a product candidate;

35

    ●
    the FDA or comparable non-U.S. regulatory authorities may disagree with our clinical trial design or our interpretation of data from preclinical studies and clinical trials;

    ●
    the FDA or comparable non-U.S. regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or facilities of third-party manufacturers with which we enter into agreements for clinical and commercial supplies;

    ●
    the supply or quality of raw materials or manufactured product candidate or other materials necessary to conduct clinical trials of our product candidate may be insufficient, inadequate, delayed, or not available at an acceptable cost, or we may experience interruptions in supply; and

    ●
    the approval policies or regulations of the FDA or comparable non-U.S. regulatory authorities may significantly change in a manner rendering our clinical data insufficient to obtain marketing approval.

Product development costs
for us will increase if we experience delays in testing or pursuing marketing approvals and we may be required to obtain additional funds
to complete clinical trials and prepare for possible commercialization of our product candidates. We do not know whether any preclinical
tests or clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. Significant
preclinical or clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our
product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize
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