Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1648

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1648
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 of the institutions in which such clinical trials are being conducted,
by the Data Safety Monitoring Board for such clinical trial or by the FDA or other regulatory authorities. Such authorities may suspend
or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory
requirements or our clinical trial protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory
authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a
benefit from the product candidates, changes in governmental regulations or administrative actions or lack of adequate funding to continue
the clinical trial. For example, in July 2024, we announced a clinical hold as a result of insufficient data provided with regard to two
issues within pharmacology and toxicology of CER-1236. In November 2024, we announced that the clinical hold was resolved and that the
FDA had cleared our IND for Phase 1 clinical trials.

63

Any delay in obtaining, or
inability to obtain, applicable regulatory approval would delay or prevent commercialization of our product candidates and would materially
adversely impact our business and prospects and our ability to generate revenues from any of these product candidates will be delayed
or not realized at all. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical
trials may also ultimately lead to the denial of regulatory approval of our product candidates. If one or more of our product candidates
generally prove to be ineffective, unsafe or commercially unviable, our CER-T cell platform would have little, if any, value, which would
have a material and adverse effect on our business, financial condition, results of operations and prospects.

Any of these factors, many
of which are beyond our control, may result in our failing to obtain regulatory approval to market any of our product candidates, or a
delay in such approval, which would significantly harm our business, results of operations, and prospects. Of the large number of biological
products in development, only a small percentage successfully complete the FDA or other regulatory approval processes and are commercialized.
Even if we eventually complete clinical testing and receive licensure from the FDA or applicable foreign regulatory authorities for any
of our product candidates, the FDA or the applicable foreign regulatory may license our product candidates for a more limited indication
or a narrower patient population than we originally requested, and the FDA, or applicable foreign regulatory agency