Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 1693

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 1693
---
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;

●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;

89

●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 accounting policies.

The cumulative effect of
such factors could result in large fluctuations and unpredictability in quarterly and annual operating results. As a result, comparing
operating results on a period-to-period basis may not be meaningful. Investors should not rely on past results as