Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 65

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 65
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 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 to our development timelines and increased costs. We will rely
heavily on these third parties over the course of our clinical trials and we control only certain aspects of their activities. As a result,
we have less direct control over the conduct, timing and completion of these clinical trials and the management of data developed through
clinical trials than would be the case if we were relying entirely upon our own staff. Nevertheless, we are responsible for ensuring
that each of our studies is conducted in accordance with applicable protocol, legal and regulatory requirements and scientific standards
and our reliance on third parties does not relieve us of our regulatory responsibilities. We and these third parties are required to
comply with GCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product
candidates in clinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal
investigators and trial sites. If we or any of these third parties fail to comply with applicable GCP regulations, the clinical data
generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to
perform additional clinical trials before approving our marketing applications. We cannot assure you that, upon inspection, such regulatory
authorities will determine that any of our clinical trials comply with the GCP regulations. In addition, our clinical trials must be
conducted with biological product produced under cGMP regulations, including current good tissue practice (“cGTP”) regulations,
and will require a large number of test patients. Our failure or any failure by these third parties to comply with these regulations
or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory approval process.
Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws
and regulations or healthcare privacy and security laws.

Any third parties conducting
our clinical trials are not and will not be our employees and, except for remedies available to us under our agreements with such third
parties, we cannot control whether or not they devote sufficient time and resources to our product candidates. These third parties