Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 172

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 172
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 obtaining marketing approval
from regulatory authorities for the sale of any product candidate, we must complete preclinical development and then conduct extensive
clinical trials to demonstrate the safety and efficacy of our product candidate in humans. Clinical testing is expensive, difficult to
design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more clinical trials can occur
at any stage of testing. The clinical development of our product candidates is susceptible to the risk of failure inherent at any stage
of drug development, including failure to demonstrate efficacy in a clinical trial or across a broad population of patients, the occurrence
of severe or medically or commercially unacceptable adverse events, failure to comply with protocols or applicable regulatory requirements
and determination by the FDA or any comparable non-U.S. regulatory authority that a drug product is not safe or effective for its intended
uses. It is possible that even if our product candidate has a beneficial effect, that effect will not be detected during clinical evaluation
as a result of one or more of a variety of factors, including the size, duration, design, measurements, conduct or analysis of our clinical
trials. Conversely, as a result of the same factors, our clinical trials may indicate an apparent positive effect of a product candidate
that is greater than the actual positive effect, if any. Similarly, in our clinical trials we may fail to detect toxicity of, or intolerability
caused by our product candidates, or mistakenly believe that our product candidates are toxic or not well tolerated when that is not in
fact the case.

33

Success in early development
does not mean that later development will be successful because, for example, drug candidates in later-stage clinical trials may fail
to demonstrate sufficient safety and efficacy despite having progressed through initial clinical trials.

The design of a clinical trial
can determine whether its results will support approval of a product; however, flaws in the design of a clinical trial may not become
apparent until the clinical trial is well advanced or completed. In addition, preclinical and clinical data are often susceptible to varying
interpretations and analyses. Many companies that believed their product candidates performed satisfactorily in preclinical studies and
clinical trials have nonetheless failed to obtain marketing approval for the product candidates. Even if we believe that the results of
clinical trials for our product candidate warrant marketing approval, the FDA or comparable non-U.S. regulatory authorities may disagree
and may not grant marketing approval of our product candidate.

In some instances, there can
be significant variability in safety or