Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 184

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 184
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 development of our product candidates, we could suspend or terminate our trials or the FDA, the EMA or comparable foreign
regulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications.
Any data safety monitoring board may also suspend or terminate a clinical trial at any time on various grounds, including a finding that
the research patients are being exposed to an unacceptable health risk, including risks inferred from other unrelated immunotherapy trials.
Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the trial or result
in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating
medical staff, as toxicities resulting from T cell therapy are not normally encountered in the general patient population and by medical
personnel. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patient
deaths. Any of these occurrences may harm our business, financial condition and prospects significantly.

Our product candidates may target healthy
cells expressing target antigens, leading to potentially fatal adverse effects.

Our product candidates target
specific antigens that are also expressed on healthy cells. For example, cell surface phosphatidylserine, the target of CER-1236, has
been observed on activated immune cells, including platelets, and in rapidly dividing cells across various organs including the gastrointestinal
system, hepatic system, cardiovascular system, renal system, pulmonary system, and the central nervous system and related peripheral nervous
system. Our product candidates may target healthy cells, leading to serious and potentially fatal adverse effects. Even though we intend
to closely monitor the side effects of our product candidates in both preclinical studies and clinical trials, we cannot guarantee that
products will not target and kill healthy cells.

54

Our product candidates may have serious
and potentially fatal cross-reactivity to lipids, peptides or protein sequences within the body.

Our product candidates may
recognize and bind to a peptide unrelated to the target antigen to which it is designed to bind. If this peptide is expressed within normal
tissues, our product candidates may target and kill the normal tissue in a patient, leading to serious and potentially fatal adverse effects.
Additionally, our product candidates may bind with non-targeted lipids, leading to off-target reactivity. Detection of any on-target off-tumor
or non-specific-reactivity may halt or delay any ongoing clinical trials for any CER-T cell based product candidate and prevent or delay