Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 42

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 42
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 conduct clinical trials in or outside the U.S. |

Risks Related to Obtaining Regulatory Approval for Our Drug Candidates

| ● | Risks relating to fail or delay to obtain regulatory approval |

| ● | Risks relating to undesirable adverse event |

| ● | Risks relating to fail to complete the 505(b)(2) pathway for the pediatric formulation |

| ● | Risks relating to our third-party suppliers fail to comply with the FDA’s good manufacturing practice regulations or fail to respond to an FDA Form 483 or subsequent Warning Letter |

Risks Related to Commercialization of Our Drug Candidates

| ● | Risks relating to fail to achieve market acceptance |

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Risks Related to Our IP

| ● | Risks relating to being unaware of others’ pending patent applications |

| ● | Risks relating to unable to protect and enforce our IP rights throughout the world |

| ● | Risks relating to lawsuits for protecting our IP or against infringing IP rights of other parties |

| ● | Risks relating to non-compliance with patent protection requirements or obligations in the license agreements |

| ● | Risks relating to the terms and scope of our patents not sufficient to protect our candidates |

| ● | Risks relating to unable to obtain or maintain rights of the developing technology through acquisitions or licenses |

Risks Related to Our Reliance on Unrelated Parties

| ● | Risks relating to manufacturers fail to provide sufficient quantities of clinical supply on our candidate at acceptable quality levels or prices |

Risks Related to Our Industry, Business and Operation

| ● | Risks relating to not complying with laws |

| ● | Risks relating to difficulties in managing our growth |

| ● | Risks relating to unable to collaborations, strategic alliances or acquisitions or enter into royalty-seeking or sublicensing arrangements |

| ● | Risks relating to our disclosure controls and procedures and internal financial reporting controls |

| ● | Risks relating to do business internationally |

| ● | Risks relating to product liability lawsuits arise from clinical trials |

| ● | Risks relating to inadequate insurance coverage |

| ● | Risks relating to failure in safeguarding our computer network system |

| ● | Risks relating to outbreak of the novel coronavirus disease, COVID-19, or other pandemic, epidemic or outbreak of an infectious disease |

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Risks Related to Our Corporate Structure

| ● | Risks relating to our Class B shareholders have higher voting rights |

Risks Related to Our Securities

| ● | Risks relating to certain existing shareholders have substantial influence over our