Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 73

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 73
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 quality of our product                                                                                                              
 candidates or other materials necessary to conduct preclinical studies or clinical trials of our product candidates may be insufficient 
 or inadequate;                                                                                                                          |

| ● | regulators may revise the                                                                                
 requirements for approving our product candidates, or such requirements may not be as we anticipate; and |

| ● | future collaborators may                                                                          
 conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us. |

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If we are required to conduct
additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to
successfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positive
or are only moderately positive or if there are safety concerns, our business and results of operations may be adversely affected and
we may incur significant additional costs. In addition, costs to treat patients with relapsed or refractory cancer and to treat potential
side effects that may result from our product candidates can be significant. Accordingly, our clinical trial costs are likely to be significantly
higher than those for more conventional therapeutic technologies or drug product candidates.

We could also encounter
delays if a clinical trial is suspended or terminated by us, by the IRBs 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 I clinical trials.

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