Company: CERO
Filing Date: 2025-08-22
Form Type: 10-Q
Source: 0001213900-25-079898
Chunk: 340

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-08-22
Form: 10-Q
Item: Item 3
Chunk 340
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 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 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.

Changes in tax laws or regulations
that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or
results of operations.

New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any
time, which could adversely affect our business operations
and financial performance. Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified
or applied adversely to us. For example, the OBBBA was signed into law on July 4, 2025 and made significant changes to U.S. federal tax
law. Under Section 174 of the Code, in taxable years beginning after December 31, 2021, expenses that are incurred for research and development
performed