Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 75

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 75
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 city, state or federal authorities may curtail the use of these materials and interrupt our business operations.
In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our resources.
We do not have any insurance for liabilities arising from medical or hazardous materials. Compliance with applicable environmental laws
and regulations is expensive, and current or future environmental regulations may impair our research, development and production efforts,
which could harm our business, prospects, financial condition or results of operations.

We plan to rely on third parties to conduct
clinical trials for our product candidates. Any failure by a third party to meet its obligations with respect to the clinical development
of our product candidate may delay or impair our ability to obtain regulatory approval for our product candidates.

We plan to rely on contract
research organizations to conduct clinical trials relating to our product candidates. Our reliance on third parties to conduct clinical
trials could, depending on the actions of such third parties, jeopardize the validity of the clinical data generated and adversely affect
our ability to obtain marketing approval from the FDA or other applicable regulatory authorities.

Such clinical trial arrangements
will provide us with information rights with respect to the clinical data, including access to and the ability to use and reference the
data, including for our own regulatory filings, resulting from the clinical trials. If investigators or institutions breach their obligations
with respect to the clinical trials of our product candidate, or if the data proves to be inadequate, then our ability to design and conduct
any future clinical trials may be adversely affected.

44

Our reliance on these third
parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities.
For example, we will design our clinical trials and will remain responsible for ensuring that each of our clinical trials is conducted
in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with standards,
commonly referred to as good clinical practices, or GCPs, for conducting, recording and reporting the results of clinical trials to assure
that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are
protected. Our reliance on third parties that we do not control will not relieve us of these responsibilities and requirements. We also
are required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database,
ClinicalTrials.gov, within specified timeframes. Failure to do so can result in fines,