Company: CERO
Filing Date: 2025-08-22
Form Type: 10-Q
Source: 0001213900-25-079898
Chunk: 97

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-08-22
Form: 10-Q
Item: Item 1
Chunk 97
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 cost-sharing for beneficiaries. These changes are expected to reduce overall
Medicaid enrollment and access to care. Although the effect on our future product candidates or business is unknown, any decrease in
the number of insured patients 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.

●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