Company: CERO
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112619
Chunk: 253

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-11-19
Form: 10-Q
Item: Item 8
Chunk 253
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, Series D Preferred Stock
or Series E Preferred Stock and that such penalties and adjustments will not apply in the future. In addition, we cannot assure you that
we will not issue additional convertible or other derivative securities with highly dilutive penalty or adjustment provisions. As described
elsewhere in this Quarterly Report, the Company needs to obtain financing to fund its research and development activities and clinical
trials, as well as other operations. Under challenging conditions in the equity capital markets, particularly for pre-commercialization
biotech companies, we may have no viable alternatives to agreeing to inclusion of such provisions in the terms of future financings.

Disruptions at the
FDA, the SEC and other government agencies caused by reduction in staffing, funding shortages or global health concerns could hinder
their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized
in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business
may rely, which could negatively impact our business.

The ability of the FDA to review and approve
new products can be affected by a variety of factors, including staffing levels, government budget and funding levels, ability to hire
and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at
the agency have fluctuated in recent years as a result. In addition, government funding of the 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