Company: APM
Filing Date: 2025-10-14
Form Type: 424B5
Source: 0001213900-25-098635
Chunk: 19

Company: Aptorum Group Ltd
Filing Date: 2025-10-14
Form: 424B5
Chunk 19
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 progress, challenges and recommendations. Nat. Rev. Drug Discov. 18, 41-58, 2019) The cost of bringing a repurposed drug is estimated to be around US$300 million, which is only one-tenth of the development cost for a new drug. (Nosengo, N. Can you teach old drugs new tricks? Nature. 534, 314-316, 2016). In summary, drug repurposing may offer the following potential advantages:

| ● | Well-established safety profiles: The development risk for                                                                                 
 new indications can be substantially reduced by applying existing drugs that are approved or have been shown to be safe in large scale     
 late-stage trials. While safety and efficacy determinations for any new indication are ultimately made by the FDA or alternative foreign   
 regulators through their formal approval processes, existing safety data may provide a foundation for regulatory submissions. Since safety 
 accounts for approximately 30% of drug failures in clinical trials, this represents a potential advantage for repositioned drugs. (The     
 benefits of drug repositioning. (n.d.). Retrieved from https://www.ddw-online.com/the-benefits-of-drug-repositioning-1779-201104/)         |

| ● | Time-saving:                                                                                                                                                  
 As repositioned drugs can rely on existing data, including efficacy and toxicity studies, the process is usually faster than de novo                          
 development. Developing a new chemical entity (NCE) can take 10 to 17 years, depending on indications. (Roin, B. N. Solving                                   
 the Problem of New Uses, 2013). For a drug repositioning company, the development process from compound identification to launch can                          
 be around 3 to 8 years. (Walker, N. (2017, December 07). Accelerating Drug Development Through Repurposing, Repositioning and                                 
 Rescue. Retrieved from https://www.pharmoutsourcing.com/Featured-Articles/345076-Accelerating-Drug-Development-Through-Repurposing-Repositioning-and-Rescue/) |

| ● | Cost-saving: Along with time-saving, money-saving is also                                                                                                                                       
 a key benefit. The cost to relaunch a repositioned drug averages $8.4 million, whereas to relaunch a new formulation of an existing                                                             
 drug in its original indication costs an average $41.3 million. Given that the average cost of launching a new chemical entity (NCE)                                                            
 is