Company: CERO
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112619
Chunk: 538

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-11-19
Form: 10-Q
Item: Part II, Item 1A
Chunk 538
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 other actions, the order directs HHS to revise guidance
    under the Inflation Reduction Act (“IRA”) to eliminate the so-called “pill penalty,” which currently subjects
    small molecule drugs to Medicare price negotiation four years earlier than biologics. The order also calls for a comprehensive evaluation
    of the role played by pharmacy benefit managers (“PBMs”) in drug pricing and market access.

The continuing efforts
of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs
of healthcare and/or impose price controls may adversely affect:

    ●
    the demand
    for our product candidates, if we obtain regulatory approval;

    ●
    our ability
    to set a price that we believe is fair for our products;

    ●
    our ability
    to obtain coverage and reimbursement approval for a product;

    ●
    our ability
    to generate revenue and achieve or maintain profitability;

    ●
    the level
    of taxes that we are required to pay; and

    ●
    the availability
    of capital.

Any reduction in reimbursement
from Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affect
our future profitability.

48

We face risks associated
with tariffs and other trade restrictions, which may have a material adverse impact on our results of operations and financial condition.

We face risks related to
tariffs and other trade protection measures—including those that have been or may be imposed by the United States or other countries—as
well as import or export licensing requirements, trade embargoes, sanctions (including those administered by the U.S. Department of the
Treasury’s Office of Foreign Assets Control), and other trade barriers (including further legislation or actions taken by the United
States or other countries that restrict trade). These risks include protectionist or retaliatory measures that may limit or complicate
the sourcing of raw materials, equipment, and other components critical to our research and development activities.

The United States has imposed
significant tariffs on a range of imported goods, including a baseline tariff of 10% and higher rates targeting specific countries. In
response, several countries have enacted retaliatory measures, and the situation remains unpredictable. While pharmaceutical end-products
are currently excluded from certain tariffs, current or future tariffs will result in increased research and development expenses, including
with respect to increased costs associated with active pharmaceutical ingredients (APIs), raw materials, laboratory equipment and research
materials and components.