Company: CERO
Filing Date: 2025-07-21
Form Type: S-1
Source: 0001213900-25-066152
Chunk: 125

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-07-21
Form: S-1
Chunk 125
---
 stock price and stock price volatility, the magnitude of the expense that we must recognize may vary significantly. Furthermore, operating results may fluctuate due to a variety of other factors, many of which are outside of our control and may be difficult to predict, including the following:

| ● | delays in the commencement, enrollment and the timing of clinical testing for our product candidates; |

| ● | the timing and success or failure of clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners; |

| ● | any delays in regulatory review and approval of product candidates in clinical development; |

| ● | the timing and cost of, and level of investment in, R&D activities relating to our product candidates, which may change from time to time; |

| ● | the cost of manufacturing our product candidates, which may vary depending on FDA guidelines and requirements, and the quantity of production; |

| ● | our ability to obtain additional funding to develop product candidates; |

| ● | expenditures that our will or may incur to acquire or develop additional product candidates and technologies; |

66

| ● | the level of demand for our product candidates, should they receive approval, which may vary significantly; |

| ● | potential side effects of our product candidates that could delay or prevent commercialization or cause an approved drug to be taken off the market; |

| ● | the ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for our product candidates, if approved; |

| ● | our dependency on third-party manufacturers to supply or manufacture our product candidates; |

| ● | our ability to establish an effective sales, marketing and distribution infrastructure in a timely manner; |

| ● | market acceptance of our product candidates, if approved, and our ability to forecast demand for those product candidates; |

| ● | our ability to receive approval and commercialize product candidates outside of the United States; |

| ● | our ability to establish and maintain collaborations, licensing or other arrangements; |

| ● | our ability and third parties’ abilities to protect intellectual property rights; |

| ● | costs related to and outcomes of potential litigation or other disputes; |

| ● | our ability to adequately support future growth; |

| ● | our ability to attract and retain key personnel to manage our business effectively; |

| ● | potential liabilities associated with hazardous materials; |

| ● | our ability to maintain adequate insurance policies; and |

| ● | future accounting pronouncements or changes in our