Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 52

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 52
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 of these financial statements. These financial statements do not include any adjustments to reflect the
possible future effect on the recoverability and classification of assets or the amounts and classifications of liabilities that may result
from the outcome of these uncertainties. Management intends to pursue additional funding and implement its strategic plan to allow the
opportunity for the Company to continue as a going concern, however, there cannot be any assurance that we will be successful in doing
so. The opinion of our independent registered public accounts on our audited financial statements for the year ended December 31, 2024,
contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.

There is no assurance that
we will be successful in raising the additional funds needed to fund our business plan. If we are not able to raise sufficient capital
in the near future, our continued operations will be in jeopardy and we may be forced to cease operations and sell or otherwise transfer
all or substantially all of our remaining assets.

We face intense competition in the markets
targeted by our lead product candidates. Many of our competitors have substantially greater resources than we do, and we expect that all
of our product candidates under development will face intense competition from existing or future drugs. 

We expect that our product
candidates under development, if approved, will face intense competition from existing and future drugs marketed by large companies. These
competitors may successfully market products that compete with our products, successfully identify drug candidates or develop products
earlier than we do, or develop products that are more effective, have fewer side effects or cost less than our products, if any.

Additionally, if a competitor
receives FDA approval before we do for a drug that is similar to one of our product candidates, FDA approval for our product candidate
may be precluded or delayed due to periods of non-patent exclusivity and/or the listing with the FDA by the competitor of patents covering
its newly-approved drug product. Periods of non-patent exclusivity for new versions of existing drugs such as our current product candidates
can extend up to three and one-half years. See the section entitled “Government Regulation.”

These competitive factors
could require us to conduct substantial new research and development activities to establish new product targets, which would be costly
and time-consuming. These activities would adversely affect our ability to commercialize products and achieve revenue and profits.

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Competition and technological change may
make our product candidates and technologies less attractive or obsolete.

We compete with established
pharmaceutical