Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 192

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1A
Chunk 192
---
 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 could be adversely affected by changes in national or global economic conditions. These conditions include but are not limited
to inflation, rising interest rates, availability of capital markets, energy availability and costs, the negative impacts caused
by pandemics and public health crises, negative impacts resulting from the military conflict between Russia and the Ukraine, and the effects
of governmental initiatives to manage economic conditions. Impacts of such conditions could be passed on to our business in the form of
higher costs for labor and materials, higher investigator fees, possible reductions in pharmaceutical industry-wide spending on research
and development and acquisitions and higher costs of capital.

Public health threats could have an
adverse effect on our operations and financial results.

Public health threats, such
as the novel