Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 79

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 79
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 continued focus by the U.S. Congress and the Biden Administration on regulating pricing
and access to medicine. For example, in August 2022, the drug pricing provisions of the IRA were signed into law, which, among other things,
require manufacturers of certain drugs to engage in price negotiations with Medicare which will permit the CMS to set a maximum fair price
for selected drugs, impose rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation, and replace
the Part D coverage gap discount program with a new discounting program. The drug pricing provisions of the IRA began to be implemented
in 2022 and implementation efforts are expected to continue over the next several years. In August 2023, the Biden Administration unveiled
the first round of medicines subject to the Medicare Drug Pricing Negotiation Program. Health plans may also require rebates in addition
to the maximum fair price for preferred placement on a Medicare plan formulary. The Medicare Drug Price Negotiation Program is currently
subject to legal challenges and therefore, the outcome of the 340B Program remains uncertain.

46

Payors may promote generic
drugs and biosimilars more aggressively to generate savings and attempt to stimulate additional price competition. In addition, we expect
that consolidation and integration among pharmacy chains, wholesalers and PBMs will increase pricing pressures in the industry. Some states
have implemented, and others are considering, patient access constraints or cost cutting under state regulated programs including the
Medicaid program. State legislatures also have continued to focus on addressing drug costs, generally by increasing price transparency
or attempting to limit drug price increases for state regulated insurance. Measures to regulate prices or payment for pharmaceutical products,
including legislation on drug importation, such as Florida’s drug importation program which was recently approved by the FDA, could
adversely affect our business.

We may encounter similar regulatory
and legislative issues in other countries in which we may operate. In certain markets, such as in EU member states, the U.K., Japan, China,
Canada and South Korea, governments have significant power as large single payors to regulate prices, access criteria, or impose other
means of cost control, particularly as a result of recent global financing pressures.

Deterioration in general economic conditions
in the United States, Canada and globally, including the effect of prolonged periods of inflation on our suppliers, third-party
service providers and potential partners, could harm our business and results of operations.

Our business and results of
operations