Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 1

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 1
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 announced by the PCAOB on December 16, 2...  
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  The uncertainties with respect to the Chinese legal system, including uncertainties regarding the enforcement of laws, and sudden or unexpected changes in laws and regulations in China with lit...  

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  

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