Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 78

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 78
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, 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 competing generics or biosimilars. This provision is limited in terms of the number of pharmaceuticals
whose prices can be negotiated in any given year and it only applies to drug products that have been approved for at least 9 years and
biologics that have been licensed for 13 years. Drugs and biologics that have been approved for a single rare disease or condition are
categorically excluded from price negotiation. Further, the new legislation provides that if pharmaceutical companies raise prices in
Medicare faster than the rate of inflation, they must pay rebates back to the government for the difference. The new law also caps Medicare
out-of-pocket drug costs at an estimated $4,000 a year in 2024 and, thereafter beginning in 2025, at $2,000 a year.

Government regulations could impact
our ability to price our products

U.S. and international governmental
regulations that mandate price controls or limitations on patient access to our drugs under development, create coverage criteria or establish
prices paid by government entities or programs for our potential products could impact our business, and our future results could be adversely
affected by changes in such regulations or policies. In addition to the recent expansion of price controls in the U.S. in the IRA, the
adoption of restrictive coverage policies and price controls in new jurisdictions, more restrictive controls in existing jurisdictions
or the failure to obtain or maintain timely or adequate coverage and pricing could also adversely impact future revenue. We expect pricing
pressures and other cost containment measures for drugs and vaccines will continue globally.

In the U.S., pharmaceutical
product pricing is subject to government and public scrutiny and calls for reform, and many of our products are subject to increasing
pricing pressures as a result. We expect to see