Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 43

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 43
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 the enforcement of laws, and sudden or unexpected changes in laws and regulations in China with little advance notice could adversely affect us and limit the legal protections available to you and us. |

Risks Related to the Preclinical and Clinical Development of Our Drug Candidates

| ● | Risks relating to not generate sufficient revenue |

| ● | Risks relating to uncertainty in preclinical development process |

| ● | Risks relating to fail to identify additional drug candidates |

| ● | Risks relating to 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 |