Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 190

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 190
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ACA imposed
a significant annual fee on companies that manufacture or import branded prescription drug products and required manufacturers to provide
a discount, equal to 70% off, effective as of 2019, the negotiated price of prescriptions filled by beneficiaries in the Medicare Part
D coverage gap, referred to as the “donut hole.” Legislative and regulatory proposals have been introduced at both the state
and federal level to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.

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Moreover, payment methodologies
may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new payment and delivery
models, such as bundled payment models. In addition, recently there has been heightened governmental scrutiny over the manner in which
manufacturers set prices for their marketed products, which has resulted in several U.S. Congressional inquiries and proposed and enacted
federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription
drugs under government payor programs, and review the relationship between pricing and manufacturer patient programs. We also expect that
additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal
government will pay for healthcare products and services, which could result in reduced demand for our drug candidates, if approved for
commercialization.

In Europe, the United Kingdom
withdrew from the European Union on January 31, 2020, and entered into a transition period that expired on December 31, 2020. A significant
portion of the previous regulatory framework in the United Kingdom was derived from the regulations of the European Union. In 2021, the
United Kingdom’s Medicines and Healthcare products Regulatory Agency, or MHRA, and the European Medicines Agency, or EMA, released
guidance explaining the new regulatory framework. We cannot predict the consequences or impact that the new regulatory framework will
have on our future operations, if any, in these jurisdictions.

In addition, on August 16,
2022, President Biden signed into law the Inflation Reduction Act of 2022, which, among other things, includes policies that are designed
to have a direct impact on drug prices and reduce drug spending by the federal government, which shall take effect in 2023. Under the
Inflation Reduction Act, Congress authorized Medicare beginning in 2026 to negotiate lower prices for certain costly single-source drug
and biologic products that do not have