Company: CERO
Filing Date: 2025-08-22
Form Type: 10-Q
Source: 0001213900-25-079898
Chunk: 429

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-08-22
Form: 10-Q
Item: Part II, Item 1
Chunk 429
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 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, Common Warrants and other securities that we may issue in future financing transactions
may result in substantial dilution to our stockholders.

As of August 19, 2025,
the Company currently has outstanding (i) 1,429 shares of Series A Preferred Stock with a conversion value of approximately $1.4
million, convertible into shares of Common Stock at a conversion rate of the stated value thereof divided by a current effective
conversion price of $1.76; (ii) 7 shares of Series C Preferred Stock with a stated value of approximately $7,000, convertible into
shares of Common Stock at a conversion rate of the stated value thereof divided by a conversion price ranging from $5.00 to $1.76
(iii) Series A Warrants to purchase 306 shares of Common Stock at an exercise price