Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 63

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 63
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 authorities may still impose significant restrictions
on the indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies. CER-1236 and other product
candidates will also be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion,
sampling, record-keeping, and submission of safety and other post-market information. The FDA has significant post-market authority,
including, for example, the authority to require labeling changes based on new safety information and to require post-market studies
or clinical trials to evaluate serious safety risks related to the use of a biologic. Any regulatory approvals that we receive for CER-1236
or other product candidates may also be subject to a REMS, limitations on the approved indicated uses for which the product may be marketed
or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including post-approval clinical
trials, and surveillance to monitor the quality, safety, and efficacy of the product, all of which could lead to lower sales volume and
revenue. For example, the holder of an approved BLA is obligated to monitor and report adverse events and any failure of a product to
meet the specifications in the BLA. The holder of an approved BLA also must submit new or supplemental applications and obtain FDA
approval for certain changes to the approved product, product labeling, or manufacturing process. Advertising and promotional materials
must comply with FDA rules and are subject to FDA review, in addition to other potentially applicable federal and state laws.

In addition, product manufacturers
and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory
authorities for compliance with cGMP requirements and adherence to commitments made in the BLA or foreign marketing application. If we,
or a regulatory authority, discover(s) previously unknown problems with a product, such as adverse events of unanticipated severity
or frequency, or problems with the facility where the product is manufactured or disagrees with the promotion, marketing or labeling
of that product, a regulatory authority may impose restrictions relative to that product, the manufacturing facility or us, including
requiring recall or withdrawal of the product from the market or suspension of manufacturing.

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If we or our contractors
fail to comply with applicable regulatory requirements following approval of CER-1236 or our other product candidates, a regulatory authority
may:

| ● | issue a warning letter,                                                      
 untitled letter, or Form