Company: CERO
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112619
Chunk: 384

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-11-19
Form: 10-Q
Item: Item 3
Chunk 384
---
 pricing. On September 30, 2025, the White House announced the first MFN agreement (Pfizer), and
    reports indicate additional negotiations are ongoing. The scope, timing, and ultimate impact of any further actions or agreements
    remain uncertain. Further, in September and October 2025, multiple drug manufacturers announced plans to, for certain of their drugs,
    lower prices to reflect similar pricing around the world, and to sell these reduced-price drugs on a direct-to-consumer purchasing
    platform that is yet to be developed by the federal government.

    ●
    Previously,
    on April 15, 2025, President Trump issued the executive order “Lowering Drug Prices by Once Again Putting Americans First,”
    which contains a broad set of directives aimed at reducing drug costs. Among 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