Company: CERO
Filing Date: 2025-11-20
Form Type: 424B3
Source: 0001213900-25-113117
Chunk: 116

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-11-20
Form: 424B3
Chunk 116
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 healthcare products and services could negatively impact our business, operations
and financial condition.

There have been, and likely
will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability
of healthcare and containing or lowering the cost of healthcare. For more information, see the section of titled “Business – Healthcare Laws and Regulations – Healthcare Reform” in the Annual Report on Form 10-K for the year ended December 31,
2024.

For example, the Medicare
Drug Price Negotiation Program, administered by CMS as part of the Inflation Reduction Act of 2022, commonly referred to as the IRA,
may apply to our products if they are selected for negotiation, which could materially reduce the amount of revenue we can generate from
our products if they are approved. Prior to the enactment of the One Big Beautiful Bill Act of 2025 (“OBBBA”), orphan drugs
were exempt from Medicare price negotiation under the IRA only if they had received a single orphan designation and were approved solely
for the corresponding rare disease or condition. The OBBBA amended this exemption to apply more broadly: now, any orphan-designated drug
is exempt from price negotiation, regardless of the number of orphan designations it has received, provided the drug’s approved
indications are exclusively for those rare diseases. The OBBBA also included significant reforms to Medicaid, including an estimated
$1 trillion in reduced federal Medicaid spending from 2025 through 2034, the imposition of work requirements for certain adult enrollees,
more frequent eligibility redeterminations, and increased 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:

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; |

|