Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 122

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 122
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| ● | delays in identifying, recruiting and training suitable investigators and achieving and maintaining sufficient 
 enrollment by patients in our clinical studies;                                                                |

| ● | failure by our CROs, other third parties or us to adhere to clinical study protocols, failure to perform                      
 in accordance with the FDA’s or any other regulatory authority’s GCP, or applicable regulatory guidelines in other countries, 
 or occurrence of adverse events in trials of comparable products conducted by other companies;                                |

| ● | occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential 
 benefits;                                                                                                    |

| ● | greater than anticipated costs of clinical studies; |

| ● | negative or inconclusive results produced by our studies, or the failure to meet the level of statistical                               
 significance required by the FDA or other regulatory authorities, requiring us to conduct additional clinical or preclinical testing or 
 to abandon programs; and                                                                                                                |

| ● | the FDA or similar foreign regulatory authorities may change their approval policies or adopt new regulations                         
 that may negatively affect or delay our ability to bring a product candidate to market or receive approvals or certification to treat 
 new indications.                                                                                                                      |

| 48 |

Patient enrollment
in clinical studies and completion of patient follow-up depend on many factors, including the size of the patient population, the severity
of the disease under investigation, the design of the trial protocol, the proximity of patients to clinical sites, the eligibility criteria
for the clinical study, patient compliance, the ability to monitor patients adequately during and after treatment, competing clinical
studies and clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in
relation to other available therapies, including any new treatments that may be approved for the indications we are investigating. In
addition, patients participating in our clinical studies may drop out before completion of the trial or experience adverse medical events
unrelated to our product candidates. Delays in patient enrollment or failure of patients to continue to participate in a clinical study
may delay commencement or completion of the clinical study, cause an increase in the costs of the clinical study and delay, or result
in the failure of the clinical study.

Failures or perceived failures
in our clinical studies will delay and may prevent the development and regulatory approval or certification of our product candidates,
damage our business prospects and negatively affect our reputation and competitive position.

Failure of clinical
studies can occur at any stage of clinical testing. Our clinical studies may produce negative or inconclusive results, requiring us to