Company: CERO
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112619
Chunk: 112

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-11-19
Form: 10-Q
Item: Item 1
Chunk 112
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 or reimbursement levels for our products could adversely affect our potential for revenue and our commercial
prospects.

In addition, multiple executive
actions in the first half of 2025 signal the federal government’s increasing focus on lowering prescription drug prices, adding
to the uncertainty surrounding future drug pricing and reimbursement frameworks. For example:

    ●
    On
    May 12, 2025, President Trump signed the executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing,”
    which directs the Secretary of Health and Human Services (“HHS”) to identify and communicate most-favored-nation price
    targets for prescription drugs and to propose a rulemaking plan to impose such pricing if “significant progress” is not
    made. The order also directs the federal government to explore regulatory pathways that would facilitate direct-to-patient sales
    for manufacturers that meet these price targets. Additionally, it signals potential further action against manufacturers that fail
    to offer most-favored-nation pricing, including evaluating whether to modify or rescind marketing approvals or allow individual drug
    importation waivers. In July 2025, President Trump sent letters to pharmaceutical companies demanding further reduced prices more
    in line with most-favored-nation 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