Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 170

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 170
---
 that designation may not lead to a faster regulatory review or approval process and, in any event, would not assure
FDA approval.

We may be eligible for priority
review designation for our product candidate if the FDA determines such product candidate offers major advances in treatment or provides
a treatment where no adequate therapy exists. A priority review designation means that the goal for the FDA is to take action on an application
in six months, rather than the standard review period of ten months. The FDA has broad discretion with respect to whether or not to grant
priority review status to a product candidate, so even if we believe a particular product candidate is eligible for such designation or
status, the FDA may decide not to grant it. Thus, while the FDA has granted priority review to other oncology disease products, our product
candidate, should we determine to seek priority review, may not receive similar designation. Moreover, even if our product candidate is
designated for priority review, such a designation does not necessarily mean a faster regulatory review process or necessarily confer
any advantage with respect to approval compared to conventional FDA procedures. Receiving priority review from the FDA does not guarantee
approval within an accelerated timeline or thereafter.

32

We believe we may in some instances be able
to secure approval from the FDA or comparable non-U.S. regulatory authorities to use accelerated development pathways. If we are unable
to obtain such approval, we may be required to conduct additional preclinical studies or clinical trials beyond those that we contemplate,
which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals.

We anticipate that we may
seek an accelerated approval pathway for our product candidates. Under the accelerated approval provisions in the Federal Food, Drug,
and Cosmetic Act, or FDCA, and the FDA’s implementing regulations, the FDA may grant accelerated approval to a product designed
to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination
that the product has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical
benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given
disease, such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such
as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not
itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint