Company: CMND
Filing Date: 2025-12-05
Form Type: F-1/A
Source: 0001213900-25-118772
Chunk: 47

Company: Clearmind Medicine Inc.
Filing Date: 2025-12-05
Form: F-1/A
Chunk 47
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 of trial participants, or those with required or desired characteristics to achieve diversity in a study, to initiate and complete any future clinical studies in a timely manner. Patient and subject enrollment is affected by factors including:

| ● | the size and nature of a patient population; |

| ● | the patient eligibility criteria defined in the applicable clinical trial protocols, which may limit the patient populations eligible for clinical trials to a greater extent than competing clinical trials for the same indication; |

| ● | the size of the study population required for analysis of the trial’s primary endpoints; |

| ● | the severity of the disorder under investigation; |

| ● | the proximity of patients to a trial site; |

| ● | the inclusion and exclusion criteria for the trial in question; |

| ● | the design of the trial protocol; |

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

| ● | the approval or concurrent enrollment of clinical trials involving competing product candidates currently under development or competing clinical trials for similar therapies or targeting patient populations meeting our patient eligibility criteria; |

| ● | the availability and efficacy of approved medications or therapies for the disorder or condition under investigation; |

| ● | clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies and product candidates; |

| ● | the ability to obtain and maintain patient consents; and |

| ● | the risk that patients enrolled in clinical trials will not complete such trials, for any reason. |

Additionally, our or our collaborators’ ability to successfully initiate, enroll and conduct a clinical trial outside the United States is subject to numerous additional risks, including:

| ● | difficulty in establishing or managing relationships with CROs and physicians; |

| ● | differing standards for the conduct of clinical trials; |

| ● | differing standards of care for patients with a particular disorder; |

| ● | an inability to locate qualified local consultants, physicians and partners; and |

| ● | the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical and biotechnology products and treatments. |

29 Further, successful and timely enrollment in clinical trials may be adversely affected by global health factors, including, among other things, pandemics such as a resurgence of COVID-19, such as:

| ● | the diversion of healthcare resources away from the conduct of clinical trial matters to focus on pandemic concerns, including the attention of physicians serving as our clinical trial investigators, hospitals