Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 3

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 3
Chunk 3
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 and commercializing drug candidates following regulatory approvals and marketing authorizations, either directly or with a collaborator or distributor;                                     
  obtaining market acceptance of our drug candidates as viable treatment options;                                                                                                                       

  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 app...  
  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 our Class A Ordinary Shares, which could impair
our ability to raise capital, expand our 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