Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 189

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 189
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 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 under the Medicaid Drug Rebate Program by increasing the minimum rebate amount for both branded and generic drugs and revised
the definition of “average manufacturer price,” or AMP, which may also increase the amount of Medicaid drug rebates manufacturers
are required to pay to states. The legislation also expanded Medicaid drug rebates and created an alternative rebate formula for certain
new formulations of certain existing products that is intended to increase the rebates due on those drugs. The Centers for Medicare &
Medicaid Services, or CMS, which administers the Medicaid Drug Rebate Program, also has proposed to expand Medicaid rebates to the utilization
that occurs in the territories of the U.S., such as Puerto Rico and the Virgin Islands. Further, beginning in 2011, the PP