Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 49

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 49
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Budget Control Act, as amended, resulted in the imposition of 2% reductions in Medicare payments to providers, which began in April 2013
and will remain in effect through 2031 unless additional Congressional action is taken. In 2021, President Biden signed the American Rescue
Plan Act of 2021 into law, which eliminated the statutory Medicaid drug rebate cap, previously set at 100% of a drug’s average manufacturer
price, for single source and innovator multiple source drugs, beginning in 2024. These laws and regulations may result in additional reductions
in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we
may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.

In
August 2022, the Inflation Reduction Act of 2022 (IRA) was signed into law. The IRA includes several provisions including provisions that
create a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, impose new manufacturer financial liability on all drugs in Medicare
Part D, allow the U.S. government to negotiate Medicare Part B and Part D pricing for certain high-cost drugs and biologics without generic
or biosimilar competition, require companies to pay rebates to Medicare for drug prices that increase faster than inflation and delay
the rebate rule that would require pass through of pharmacy benefit manager rebates to beneficiaries. The effect of IRA on our business
and the healthcare industry in general is not yet known.

Further,
there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which
have resulted in several Congressional inquiries and proposed bills designed to, among other things, bring more transparency to product
pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies
for products. In addition, the federal government, state legislatures, and foreign governments have shown significant interest in implementing
cost containment programs, including price-controls and price transparency, restrictions on reimbursement, and requirements for substitution
of generic products for branded prescription drugs to limit the growth of government paid health care costs. For example, the federal
government has passed legislation requiring pharmaceutical manufacturers to provide rebates and discounts to certain entities and governmental
payors to participate in federal healthcare programs.

28

Human Capital Resources

As of December 31, 2024, we
had 13 full-time employees in the United States and 9 full-time employees in the United Kingdom. We consider the intellectual capital