Company: CERO
Filing Date: 2025-11-20
Form Type: 424B3
Source: 0001213900-25-113118
Chunk: 111

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-11-20
Form: 424B3
Chunk 111
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 we do, that exclusivity may not prevent regulatory authorities from approving other competing products.

In June 2025, the FDA granted
orphan drug designation to CER-1236 for the treatment of AML. We may seek orphan designation for additional product candidates in the
future; however, we may never receive such designations. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug
if it is a drug or biologic intended to treat a rare disease or condition, defined as a patient population of fewer than 200,000 in the
U.S., or a patient population greater than 200,000 in the U.S. where there is no reasonable expectation that the cost of developing the
drug will be recovered from sales in the U.S. Orphan drug designation must be requested before submitting an NDA. A similar regulatory
scheme governs orphan products in the EU.

Orphan drug designation
entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and application
fee 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