Company: APM
Filing Date: 2025-01-03
Form Type: 424B5
Source: 0001213900-25-000606
Chunk: 7

Company: Aptorum Group Ltd
Filing Date: 2025-01-03
Form: 424B5
Chunk 7
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 including Paths DxTest, a novel molecular-based rapid pathogen identification and detection diagnostics technology. Paths DxTest technology is currently under co-development with A*STAR. The core objectives of Paths DxTest are to rapidly and accurately identify and detect existing or emerging unknown pathogens (including DNA/RNA-based viruses such as coronavirus, antibiotic-resistant bacteria, fungi, etc.), in a cost-effective, unbiased and broad-spectrum manner, through liquid biopsy (patients’ blood samples and is potentially adaptable for other sample types), genome sequencing and artificial intelligence driven software analytics. A key objective is also to develop Paths DxTest to leverage existing and emerging Next-Generation Sequencing platforms for pathogenic genome sequencing analysis. Our goal is to develop a broad range of novel and repurposed therapeutics and diagnostics technology across a wide range of disease/therapeutic areas. Key components of our strategy for achieving this goal include: (for details of our strategy, See “Item 4. Information on the Company – B. Business Overview – Our Strategy” in our annual report on Form 20-F filed on April 30, 2024)

| ● | Developing therapeutic and diagnostic innovations across a wide range of disease/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. |

We have devoted a substantial portion of the proceeds from our offerings to our Lead Projects. Our Lead Projects are ALS-4, SACT-1 and Paths DxTest. 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. We commenced clinical validation of our molecular based Paths DxTest and will continue to undergo validations in parallel with its pre-commercialization process. During