Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 171

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 171
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 that can be measured earlier than an effect
on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other
clinical benefit. The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may
not be a direct therapeutic advantage but is a clinically important improvement from a patient and public health perspective. If granted,
accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval
confirmatory studies to verify and describe the drug’s clinical benefit. If such post-approval studies fail to confirm the drug’s
clinical benefit, the FDA may withdraw its approval of the drug.

Prior to seeking such accelerated
approval, we will seek feedback from the FDA and will otherwise evaluate our ability to seek and receive such accelerated approval. There
can be no assurance that after our evaluation of the feedback and other factors we will decide to pursue or submit a New Drug Application,
or NDA, for accelerated approval or any other form of expedited development, review or approval. Similarly, there can be no assurance
that after subsequent FDA feedback we will continue to pursue or apply for accelerated approval or any other form of expedited development,
review or approval, even if we initially decide to do so. Furthermore, if we decide to submit an application for accelerated approval
or under another expedited regulatory designation (e.g., breakthrough therapy designation), there can be no assurance that such submission
or application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all. The
FDA or other non-U.S. authorities could also require us to conduct further studies prior to considering our application or granting approval
of any type. 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