Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 59

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 59
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. A failure to obtain accelerated approval or any other form of expedited development, review or approval for our product candidate
would result in a longer time period to commercialization of such product candidate, could increase the cost of development of such product
candidate and could harm our competitive position in the marketplace.

Clinical drug development involves a lengthy
and expensive process with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable
to complete the development and commercialization of our product candidate.

Our product candidates are
in early clinical development. Therefore, the risk of failure of our product candidates is high. It is impossible to predict when or if
our product candidates will prove effective or safe in humans or will receive regulatory approval. Before 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