Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1615

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1615
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 participate in clinical trials of our product candidates will be critical to our success. We may experience difficulties in
patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their
protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion.
The enrollment of patients depends on many factors, including:

●the patient eligibility criteria defined in the protocol;

●the number of patients with the disease or condition being studied;

●the perceived risks and benefits of the product candidate in the trial;

●clinicians’ and patients’ perceptions as to the potential advantages of the product candidate
being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating
or drugs that may be used off-label for these indications;

●the size and nature of the patient population required for analysis of the trial’s primary and secondary
endpoints;

●the proximity of patients to study sites;

●the design of the clinical trial;

●our ability to recruit clinical trial investigators with the appropriate competencies and experience;

●competing clinical trials for similar therapies or other new therapeutics not involving T cell-based immunotherapy;

●our ability to obtain and maintain patient consents;

●the risk that patients enrolled in clinical trials will drop out of the clinical trials before completion
of their treatment; and

●other public health factors, including the coronavirus pandemic or outbreaks of other infections.

In particular, some of our
clinical trials will look to enroll patients with characteristics which are found in a very small population. For example, our clinical
trial for CER-1236 will seek to enroll patients with hematologic malignancies, including AML, MCL, CLL, and other B cell and myeloid neoplasms.
Other companies are conducting clinical trials with their engineered T cell therapies in hematologic malignancies and seek to enroll patients
in their studies that may otherwise be eligible for our clinical trials, which could lead to slow recruitment and delays in our clinical
trials. In addition, since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials
at the same clinical trial sites that some of our competitors use, which could further reduce the number of patients who are available
for our clinical trials in these clinical trial sites.

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Moreover, because our product
candidates represent a departure from more commonly used methods for cancer treatment, potential study participants and their doctors
may be inclined