Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 76

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 76
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Moreover, if any of our
product candidates are approved, our product labeling, advertising and promotion will be subject to regulatory requirements and continuing
regulatory review. The FDA strictly regulates the promotional claims that may be made about biopharmaceutical products. In particular,
a product may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling.

Any government investigation
of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity.
The occurrence of any event or penalty described above may inhibit our or our collaborators’ ability to commercialize our product
candidates, and harm our business, financial condition and results of operations.

In addition, the policies
of the FDA, the EMA and other comparable regulatory authorities may change and additional government regulations may be enacted that
could prevent, limit or delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes in existing
requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any
marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain
profitability.

We also cannot predict the
likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either
in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements,
or if we are unable to maintain regulatory compliance, marketing approval that has been obtained may be lost and we may not achieve or
sustain profitability.

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Regulatory requirements in the United States and abroad governing cell therapy products have changed frequently and may continue to change in the future, which could negatively impact our ability to complete clinical trials and commercialize our product candidates in a timely manner, if at all.

Regulatory requirements
in the United States and abroad governing cell therapy products have changed frequently and may continue to change in the future.
In 2016, the FDA established the Office of Tissues and Advanced Therapies (“OTAT”) within its Center for Biologics Evaluation
and Research to consolidate the review of gene therapy and related products, and has established the Cellular, Tissue and Gene Therapies
Advisory Committee, among others, to advise this review. In September 2022, the FDA announced retitling of OTAT to the Office of
Ther