Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 55

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 55
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 generate revenues. If we are unable to develop and commercialize one or more product candidates, either alone or through collaborations,
or if revenues from any product that receives marketing approval are insufficient, we will not achieve profitability. Even if we do achieve
profitability, we may not be able to sustain profitability or meet outside expectations for our profitability. If we are unable to achieve
or sustain profitability or to meet outside expectations for our profitability, the value of our common stock will be materially and adversely
affected.

Even if we are able to commercialize any
product candidate that we develop, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement
practices or healthcare reform initiatives that could harm our business.

The commercial success of
our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates
will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government
health administration authorities (such as Medicare and Medicaid), private health coverage insurers and other third-party payors. If reimbursement
is not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates. Even
if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish and maintain pricing sufficient
to realize a meaningful return on our investment.

31

There is significant uncertainty
related to third-party payor coverage and reimbursement of newly approved drugs. Marketing approvals, pricing and reimbursement for new
drug products vary widely from country to country. Some countries require approval of the sale price of a drug before it can be marketed.
In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some non-U.S. markets,
prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result,
we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay commercial
launch of the product, possibly for lengthy time periods, which may negatively impact the revenues we are able to generate from the sale
of the product in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates,
even if our product candidates obtain marketing approval.

We are subject to various government regulations.

The manufacture and sale of
human therapeutic products in the U.S. and foreign jurisdictions are governed by a variety of statutes and regulations. These laws require
approval of