Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 197

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 197
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 the FDA or the applicable foreign regulatory authority
that any of our product candidates are safe, potent and pure;

●the FDA’s or the applicable foreign regulatory agency’s disagreement with our trial protocol
or the interpretation of data from preclinical studies or clinical trials;

●our inability to demonstrate that the clinical and other benefits of any of our product candidates outweigh
any safety or other perceived risks;

●the FDA’s or the applicable foreign regulatory agency’s requirement for additional preclinical
studies or clinical trials;

●the results of clinical trials may not meet the level of statistical significance required by the FDA
or comparable foreign regulatory authorities for licensure;

●the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction
of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions
or to obtain licensure of our product candidates in the United States or elsewhere;

●reaching agreement on acceptable terms with prospective CDMOs and clinical trial sites, the terms of which
can be subject to extensive negotiation and may vary significantly among different CDMOs and clinical trial sites;

●obtaining IRB or ethics committee approval at each clinical trial site;

●recruiting an adequate number of suitable patients to participate in a clinical trial;

●having subjects complete a clinical trial or return for post-treatment follow-up;

●clinical trial sites deviating from clinical trial protocol or dropping out of a clinical trial;

●addressing subject safety concerns that arise during the course of a clinical trial;

●adding a sufficient number of clinical trial sites;

●obtaining sufficient product supply of product candidate for use in preclinical studies or clinical trials
from third-party suppliers;

●the FDA’s or the applicable foreign regulatory agency’s findings of deficiencies or failure
to approve the manufacturing processes or facilities of third-party manufacturers upon which we rely; or

●the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly
change in a manner rendering our clinical data insufficient for approval.

62

We may experience numerous
adverse or unforeseen events during, or as a result of, preclinical studies and clinical trials that could delay or prevent our ability
to receive marketing approval or commercialize our product candidates, including:

●we may receive feedback from regulatory authorities that requires us to modify the design of our clinical
trials;

●we may obtain a result from preclinical studies such as a binder specificity study or a safety toxicology
study that require us to modify the design