Company: CERO
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112619
Chunk: 434

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-11-19
Form: 10-Q
Item: Item 4
Chunk 434
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 government continues for an extended period. Currently, federal agencies in the U.S. are operating
under a federal government shutdown due to the expiration of the continuing resolution that expired on September 30, 2025. The duration
of the current government shutdown is unknown. In addition, the Trump administration has issued executive orders and taken other measures
seeking to greatly reduce the size of the federal workforce, including through layoffs and severance packages offered to employees of
federal agencies within the executive branch and independent agencies, including the FDA. Any such reduction in personnel may result
in longer review times by the FDA, the SEC and other agencies. If a prolonged government shutdown occurs, or if geopolitical or global
health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory
activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could
materially adversely affect our business, financial condition, results of operations and prospects. Further, in our operations as a public
company, future government shutdowns or substantial leadership, personnel, and policy changes could impact our ability to access the
public markets and obtain necessary capital in order to properly capitalize and continue our operations.

47

The impact of recent healthcare reform
legislation and other changes in the healthcare industry and in healthcare spending on us is currently unknown, and may adversely affect
our business model.

Our revenue prospects could
be affected by changes in healthcare spending and policy in the United States and abroad. We operate in a highly regulated industry and
new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to healthcare
availability, the method of delivery or payment for 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