Company: CERO
Filing Date: 2025-11-19
Form Type: 10-Q
Source: 0001213900-25-112619
Chunk: 378

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-11-19
Form: 10-Q
Item: Item 3
Chunk 378
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 waivers. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed
publicly by the FDA. In addition, if a product candidate with an orphan drug designation subsequently receives the first marketing approval
for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the
FDA from approving another marketing application for the same product for the same therapeutic indication for seven years.

Even if we obtain orphan
drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different products
can be approved for the same condition. In addition, even after an orphan drug is approved, the FDA can subsequently approve the same
product for the same condition if the FDA concludes that the later product is clinically superior in that it is shown to be safer, more
effective or makes a major contribution to patient care. Orphan drug exclusivity may also be lost if the FDA determines that the request
for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the product to meet the needs
of the patients with the rare disease or condition.

Additionally, the FDA may
further reevaluate the Orphan Drug Act and its regulations and policies. We do not know if, when, or how the FDA may change the orphan
drug regulations and policies in the future, and it is uncertain how any changes might affect our business. Depending on what changes
the FDA may make to its orphan drug regulations and policies, our business could be adversely impacted.

The issuance of shares of our Common Stock
upon conversion or exercise of our outstanding Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D
Preferred Stock, Series E Preferred Stock, Common Warrants and other securities that we may issue in future financing transactions may
result in substantial dilution to our stockholders.

On October 31, 2025, the Common Stock ceased trading on Nasdaq as a
result of the Panel’s delisting determination and has commenced trading on the OTC Pink Sheets. Pursuant to the Certificate of Designations
for each of Series A Preferred Stock, Series C Preferred Stock, Series D Preferred Stock and Series E Preferred Stock, the suspension
from trading or failure of the Company’s Common Stock to be trading or listed on either The New York Stock Exchange, the NYSE American,
the Nasdaq Global Select Market, the Nasdaq Global Market, or the Nasdaq Capital Market constitutes a Triggering