Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 190

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 190
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 regulatory approval;

●suspend any ongoing clinical trials;

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●refuse to approve a pending BLA or comparable foreign marketing application (or any supplements thereto);

●restrict the marketing or manufacturing of the product;

●seize or detain the product or otherwise require the withdrawal of the product from the market;

●refuse to permit the import or export of product candidates; or

●refuse to allow us to enter into supply contracts, including government contracts.

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 ability to commercialize CER-1236 or other product candidates and
adversely affect our business, financial condition, results of operations, and prospects.

Prior treatments can alter the cancer or
target of CER-T cell therapy and negatively impact chances for achieving clinical activity with our programmed T cells.

Patients with hematological
cancers receive highly toxic lympho-depleting chemotherapy as their initial treatment. These therapies can impact the viability of the
T cells collected from the patient and can contribute to highly variable responses to programmed T cell therapies. Patients could also
have received prior therapies that target the same target antigen on the cancer cells as our intended programmed T cell product candidate
and thereby lead to a selection of cancer cells with low or no expression of the target. Cancers also naturally evolve and select clones
with low or no expression of the target. As a result, our programmed T cell product candidates may not recognize the cancer cell and may
fail to achieve clinical activity. If any of our product candidates do not achieve a sufficient level of clinical activity, we may discontinue
the development of that product candidate, which could adversely affect our business, financial condition, results of operations, and
prospects.

Risks Related to Reliance
on Third-Parties

We will rely on third parties to conduct
our clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines,
we may not be able to obtain regulatory approval of or commercialize our product candidates.

We expect to utilize and
depend upon independent investigators and collaborators, such as medical institutions, CROs, CDMOs and strategic partners to conduct our
preclinical studies under agreements with us and in connection with our clinical trials. We expect to have to negotiate budgets and contracts
with CROs, trial sites and CDMOs which may result in delays