Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 35

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 35
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 CER T cell therapies for cancer; |

| ● | establishing sales and                                                                                          
 marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy; and |

| ● | obtaining acceptance and                                                                                   
 approval by physicians, patients, hospitals, cancer treatment centers and others in the medical community. |

Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or to commercialize these programs on a timely basis or at all, which would have an adverse effect on our business.

Our product candidates,
including CER-1236, are in the preclinical development stage. The risk of failure of preclinical programs is high. Before we can commence
clinical trials for a product candidate, we are nearing completion of extensive preclinical testing and studies to obtain regulatory
clearance to initiate human clinical trials with CER-1236, and have engaged in a pre-IND meeting with the FDA. We expect that our
clinical trials will be conducted on populations based in the United States and Europe. We cannot be certain of the timely completion
or outcome of our preclinical testing and studies and cannot predict if the FDA, the EMA or other regulatory authorities will accept
our proposed clinical programs or if the outcome of our preclinical testing and studies will ultimately support the further development
of our programs. As a result, we cannot be sure that we will be able to submit INDs or similar applications for our clinical programs
on the timelines we expect, if at all.

Success in preclinical studies or clinical trials may not be indicative of results in future clinical trials.

Results from preclinical
studies are not necessarily predictive of future clinical trial results, and interim results of a clinical trial are not necessarily
indicative of final results. Our product candidates may ultimately fail to show the desired safety and efficacy in clinical settings
despite positive results in preclinical studies or having successfully advanced through initial clinical trials. This failure to establish
sufficient efficacy and safety could cause us to abandon clinical development of our product candidates.

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Manufacturing genetically engineered products is complex and we, or our third-party manufacturers, may encounter difficulties in production. If we or any of our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved, could be delayed or prevented.

Manufacturing genetically
engineered products is complex and may require the use of innovative technologies to handle living cells