Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 76

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 76
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 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 commercialization of our products, producing additional
losses and depriving us of potential product revenue.

Current and future legislation may increase
the difficulty and cost of commercializing our drug candidates and may affect the prices we may obtain if our drug candidates are approved
for commercialization.

In the U.S. and some foreign
jurisdictions, there have been a number of adopted and proposed legislative and regulatory changes regarding the healthcare system that
could prevent or delay regulatory approval of our drug candidates, restrict or regulate post-marketing activities and affect our ability
to profitably sell any of our drug candidates for which we obtain regulatory approval.

In the U.S., the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003, or the MMA, changed the way Medicare covers and pays for pharmaceutical
products. Cost reduction initiatives and other provisions of this legislation could limit the coverage and reimbursement rate that we
receive for any of our approved products. While the MMA only applies to drug benefits for Medicare beneficiaries, private payors often
follow Medicare coverage policy and payment limitations in setting their own reimbursement rates. Therefore, any reduction in reimbursement
that results from the MMA may result in a similar reduction in payments from private payors.

In March 2010, the Patient
Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, collectively the PPACA, was
enacted. The PPACA was intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance
remedies against healthcare fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose
new taxes and fees on the health industry and impose additional health policy reforms. The PPACA increased manufacturers’ rebate
liability