Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 11

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 11
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therapeutic areas; |

| ● | Selectively                                                                                                                             
 expanding our portfolio with potential products that may be able to attain orphan drug designation and/or satisfy current unmet medical 
 needs;                                                                                                                                  |

| ● | Collaborating                                
 with leading academic institutions and CROs; |

| ● | Expanding                                       
 our in-house pharmaceutical development center; |

| ● | Leveraging                                                      
 our management’s expertise, experience and commercial networks; |

| ● | Obtaining                                                     
 and leveraging government grants to fund project development. |

Our Lead Projects are ALS-4 and SACT-1. In March 2023, we announced that we completed the Pre-IND discussions with the US FDA on ALS-4. With the positive feedback on the overall development strategy from the US FDA, we are proceeding towards the IND submission of ALS-4. In March 2023, we also announced the completion of the End of Phase 1 (EOP1) meeting of SACT-1 with the US FDA. The FDA generally agreed with the chemistry-manufacturing-control (CMC) strategy and our proposed clinical development plan for SACT-1 Phase 1/2 trials. Currently, ALS-4 and SACT-1 are Phase 2 clinical trials ready. During the second quarter of 2023, the Company decided to streamline its operations by terminating clinic services and suspending non-lead R&D projects. This was done to optimize the allocation of the Company’s resources and focusing efforts on advancing our lead projects, which hold the most promise for commercial success and beneficial impact. This decision aligns with our commitment to enhance shareholder value and effectively drive our core objectives forward in the competitive landscape. Our Company Aptorum is not a Chinese operating company. Aptorum is a Cayman Islands holding company with operations conducted through our subsidiaries and the variable interest entity (VIE). We have determined that we have one VIE: Libra, according to the U.S. GAAP. In accordance with ASC 810, we concluded that we are not the primary beneficiary of Libra and therefore we do not consolidate its financial statements into ours. Previously, we determined that we were the primary beneficiary of another VIE, Mios Pharmaceuticals Limited; however, Mios was dissolved on October 31, 2024 and therefore we no longer maintain any ownership over such entity. Our current corporate structure does not contain any variable interest entity in mainland China and we do not have intention establishing any VIEs in mainland China in the future. However, if