Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 55

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 55
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 a collaborator or distributor; |

| ● | obtaining market acceptance of our drug candidates as viable 
 treatment options;                                           |

28

| ● | addressing any competing technological and market developments; |

| ● | negotiating and maintaining favorable terms in any collaboration,                                                                     
 licensing or other arrangement into which we may enter to commercialize drug candidates for which we have obtained required approvals 
 and marketing authorizations; and                                                                                                     |

| ● | maintaining, protecting and expanding our portfolio of IP rights, 
 including patents, trade secrets and know-how.                    |

In addition, our ability to achieve and maintain profitability depends on timing and the amount of expenses we will incur. Our expenses could increase materially if we are required by the FDA, NMPA, EMA, Health Canada or other comparable regulatory authorities to perform studies in addition to those that we currently have anticipated. Even if our drug candidates are approved for commercial sale, we anticipate incurring significant costs associated with the commercial launch of these products. Our ability to become and remain profitable depends on our ability to generate revenue. Even if we are able to generate revenues from the sale or sublicense of any products we may develop or license, we may not become profitable on a sustainable basis or at all. Our failure to become and remain profitable would decrease the value of our Company and adversely affect the market price of Aptorum Class A ordinary shares, which could impair our ability to raise capital, expand Aptorum’s business or continue our operations. Preclinical development is a long, expensive and uncertain process, and we may terminate one or more of our current preclinical development programs. Traditionally, drug discovery and development is a time-consuming, costly and high-risk business. On average, the cost of launching a new drug is estimated to approach US$2.6 billion and can take around 12 years to make it to the market (4 key benefits of drug repositioning. (n.d.). Retrieved from http://www.totalbiopharma.com/2012/07/04/4-key-benefits-drug-repositioning/). Despite the huge expenditures, only approximately 1 in 1,000 potential drugs is graduated to human clinical trials after pre-clinical testing in the United States, (Norman, G. A. Drugs, Devices, and the FDA: Part 1. JACC: Basic to Translational Science, 1(3), 170-179, 2016) and nearly 86.2% of drug candidates entering phase 1 trials fails to achieve