Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1628

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1628
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 SEC and other government agencies on
which our 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.

51

Since March 2020, when foreign
and domestic inspections of facilities were largely placed on hold, the FDA has been working to resume pre-pandemic levels of inspection
activities, including routine surveillance, bioresearch monitoring and pre-approval inspections. Should the FDA determine that an inspection
is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel or otherwise, and
the FDA does not determine a remote interactive evaluation to be adequate, the FDA has stated that it generally intends to issue, depending
on the circumstances, a complete response letter or defer action on the application until an inspection can be completed.

Business disruptions, including financial
institution distress, could seriously harm our future revenue and financial condition and increase our costs and expenses.

Our operations, and those
of our CROs, CDMOs and other contractors and consultants, could be subject to earthquakes, power shortages, telecommunications failures,
water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical pandemics or epidemics