Company: APM
Filing Date: 2025-12-05
Form Type: 424B5
Source: 0001213900-25-118752
Chunk: 221

Company: Aptorum Group Ltd
Filing Date: 2025-12-05
Form: 424B5
Chunk 221
---
 | Potential for out-licensing:    Pharmaceutical                                                                                           
 companies are said to be exploring new models to out-license some of their clinical drug candidates that may have been shelved for pure  
 business reasons unrelated to safety or efficacy, even though they have met their endpoints and have proven themselves to be safe. If    
 such drugs were to be repositioned, the pharmaceutical company increases the attractiveness of these drugs and gives itself more options 
 to find interested buyers. (https://www.ddw-online.com/the-benefits-of-drug-repositioning-1779-201104/)                                  |

| ● | Lower failure rate: According to BCC Research, approval rates for repurposed drugs are close to 30%, 
 which is greater than the approval rate for new drug applications. (Front Oncol. 2017; 7: 273)       |

While drug repurposing presents
potential advantages, several important limitations must be considered. There is no guarantee that existing clinical data will be sufficient
for regulatory approval of new indications, and the FDA or alternative foreign regulators may require additional trials to demonstrate
safety and efficacy for new uses to the satisfaction of regulatory authorities. Even if we conclude that new use is safe, the applicable
regulator, such as the FDA, may not accept our data; final safety and efficacy are determined by the FDA or an applicable foreign regulator
as part of their approval process for the product. In such cases, development timelines may be extended and costs may increase beyond
initial projections, potentially diminishing the anticipated advantages of the repositioning approach. Additionally, there is currently
a lack of systematic methodology for identifying optimal repositioning opportunities. While drug repurposing potentially offers certain
advantages, it still involves substantial development and regulatory risks, and the potential benefits described above may not be realized
in practice.

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SACT-1 is the first repurposed
drug candidate to be developed under the Smart-ACT® drug discovery platform. SACT-1 is one of the Company’s proprietary technologies.
The approved drug, rilpivirine, which we refer to as the “Reference Drug,” was developed for the treatment of HIV/AIDS (human
immunodeficiency virus/acquired immunodeficiency syndrome). It works by inhibiting HIV reverse transcriptase, an enzyme that HIV uses
to convert its RNA into DNA, which is essential for the virus to replicate and integrate into the host cell’s genome. By using the
Smart