Company: CERO
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112619
Chunk: 110

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-11-19
Form: 10-Q
Item: Item 1
Chunk 110
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 operations may rely, including those that fund R&D activities is subject to the political process, which is inherently fluid
and unpredictable. The Trump Administration has issued executive orders 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 SEC and the FDA. Any such reduction in personnel may result in longer review times by the FDA or SEC.

Disruptions and personnel
turnover, as a result of leadership changes, staff reductions or otherwise, at the FDA and other government agencies may also slow the
time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.
In addition to the potential reduction in staffing, a government shutdown could adversely affect the FDA review process. Over the last
several years the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had
to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs,
it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material
adverse effect on our business. Further, in our operations as a public company, future government shutdowns could impact our ability
to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Similar consequences would
also result if the shutdown of the federal 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