Company: CERO
Filing Date: 2025-08-22
Form Type: 10-Q
Source: 0001213900-25-079898
Chunk: 474

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-08-22
Form: 10-Q
Item: Part II, Item 1A
Chunk 474
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Item
1a. Risk Factors

Except
as set forth below, there have been no material changes to the risk factors disclosed in our Annual Report on Form 10-K for the year
ended December 31, 2024, filed with the SEC on April 15, 2025. Any of these factors could result in a significant or material adverse
effect on our results of operations or financial condition. Additional risk factors not presently known to us or that we currently deem
immaterial may also impair our business or results of operations.

We
may pursue orphan drug designation for certain of our product candidates, and we may not be able to obtain such designation, or obtain
or maintain the benefits of such designation including orphan drug exclusivity, and even if 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