Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 39

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 39
---
 timelines we expect, and even if we are able to, the FDA may not permit us to proceed.

The IND for CER-1236 was
filed on June 28, 2024 and on November 15, 2024, the FDA cleared us to begin clinical trials, but there are no assurances regarding the
acceptance of any amendments or future INDs, which may impact the timelines we expect. For example, we may experience manufacturing delays
or other delays with future IND-enabling studies. Moreover, there can be no assurances that once trials begin, issues will not arise
that suspend or terminate such clinical trials. Additionally, even if such regulatory authorities agree with the design and implementation
of the clinical trials set forth in an IND, we cannot guarantee that such regulatory authorities will not change their requirements in
the future. These considerations also apply to new clinical trials we may submit as amendments to existing INDs.

Clinical trials are difficult to design and implement, involve uncertain outcomes and may not be successful.

Human clinical trials are
difficult to design and implement, in part because they are subject to rigorous regulatory requirements. The design of a clinical trial
can determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent
until the clinical trial is well advanced. We may be unable to design and execute a clinical trial that will be successful to achieve
regulatory approval. There is a high failure rate for biological products proceeding through clinical trials, which may be higher for
our product candidates because they are based on new technology and engineered on a patient-by-patient basis. Many companies in the pharmaceutical
and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results
in preclinical testing and earlier-stage clinical trials. Data obtained from preclinical and clinical activities are subject to varying
interpretations, which may delay, limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejections
as a result of many factors, including changes in regulatory policy during the period of our product candidate development. Any such
delays could negatively impact our business, financial condition, results of operations and prospects.

We will depend on enrollment of patients in our clinical trials for our product candidates. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

Identifying and qualifying
patients to participate in clinical trials of our product candidates will be critical to our success. We may experience