Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 188

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 188
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 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, adverse publicity and civil and criminal sanctions.

Furthermore, these third parties
may also have relationships with other entities, some of which may be our competitors. If these third parties do not successfully carry
out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our
stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidate and will
not be able to, or may be delayed in our efforts to, successfully commercialize our product candidate.

We also expect to rely on
other third parties to store and distribute drug supplies for our clinical trials. Any performance failure on the part of our distributors
could delay clinical development or marketing approval of our product candidate or