Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 198

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 198
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 (SAD) and multiple-ascending
dose studies (MAD) have been completed for a total of 72 healthy subjects and no subjects were dropped from the studies. There were no
serious adverse events observed and no relevant clinical changes in respect of vital signs. In March 2023, we announced the completion
of the Pre-IND discussions with the US FDA. The Pre-IND discussions focused on overall development plan in preparation for the IND application
of ALS-4 targeting Acute Bacterial Skin and Skin Structure Infections (ABSSSI) initially.

With the positive feedback
on the overall development strategy from the US FDA, we are proceeding towards the IND submission of ALS-4 seeking to initiate a Phase
2 clinical study to assess the efficacy of ALS-4 in patients. Currently, ALS-4 and SACT-1 are Phase 2 clinical trials ready.

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Patent License

On October 18, 2017, the Company’s
subsidiary, Acticule, entered into an exclusive license agreement with Versitech Limited, the licensing entity of HKU, for ALS-4. Subsequently
on June 7, 2018, the parties entered into a first amendment to the exclusive license agreement, and on July 10, 2019, the parties
entered into a second amendment to the license agreement.

On January 11, 2019, Acticule
and Versitech Limited entered into a second license agreement for ALS-4, where Acticule exclusively licensed the intellectual property
rights on certain HKU-owned improvements to the original licensed invention.

Under the exclusive license
agreements, we were granted an exclusive, royalty-bearing, sublicensable licenses to develop, make, have made, use, sell, offer for sale
and import products that are covered by the licensed patents (as described below). The territory of the licenses is worldwide and the
field of the licenses is for treatment or prevention of bacterial infections caused by Staphylococcus aureus including MRSA and bacterial
virulence.

We paid an upfront fee upon
entering into the license agreements. We are required to pay less than 10% of the net sales of the licensed products sold by us or our
affiliates as royalties, as well as a low teens percentage of sublicense royalties that we receive from our sublicensees, if any. In addition,
we agreed to pay to the licensor aggregate regulatory milestones of up to US$