Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1649

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1649
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, may not license our
product candidates with the labeling that we believe is necessary or desirable for the successful commercialization of such product candidates.

Our manufacturing process needs to comply
with FDA regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations could
result in delays in or termination of our clinical programs and suspension or withdrawal of any regulatory approvals.

In order to commercially
produce our products at a third party’s facility, we will need to comply with the FDA’s cGMP regulations and guidelines, including
cGTPs. We may encounter difficulties in achieving quality control and quality assurance and may experience shortages in qualified personnel.
We are subject to inspections by the FDA and comparable foreign regulatory authorities to confirm compliance with applicable regulatory
requirements. Any failure to follow cGMP, cGTP or other regulatory requirements or delay, interruption or other issues that arise in the
manufacture, fill-finish, packaging, or storage of our CER-T cells as a result of a failure of the facilities or operations of third parties
to comply with regulatory requirements or pass any regulatory authority inspection could significantly impair our ability to develop and
commercialize our CER-T cell programs, including leading to significant delays in the availability of our CER-T cells for our clinical
trials or the termination of or suspension of a clinical trial, or the delay or prevention of a filing or approval of marketing applications
for our CER-T cell product candidates. Significant non-compliance could also result in the imposition of sanctions, including warning
or untitled letters, fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approvals for our CER-T
cell product candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products, operating
restrictions and criminal prosecutions, any of which could damage our reputation and our business.

Even if we receive regulatory approval for
any of our product candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant
additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market
withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with
our products.

If the FDA, EMA or any other
comparable regulatory authority approves any of our product candidates, the manufacturing processes, labeling, packaging, distribution,
adverse event reporting, storage, advertising, promotion and recordkeeping for the product will be