Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 109

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 109
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. e., ALS-4, SACT-1 and PathsDxTest). The selection of a drug candidate is based on
our estimate of the market potential for that candidate, the scientific expertise required to develop it, and our overall corporate strategy,
including our ability to commit personnel and future investment to that candidate.

To pursue a number of our
current projects, our Project Companies have entered into standard license agreements with various universities and licensing entities
customized to the nature of each project. These license agreements largely contain the same terms, as is typically seen in license agreements
for an early-stage life science invention; such terms include a worldwide license with licensed field comprising indications in the intended
treatment areas, having upfront payments, certain royalty rates, sublicensing royalties, as well as provisions for payments upon occurrence
of development and/or regulatory milestones. Under the license agreements, the Project Company must also adhere to certain diligence obligations
(which may include specific diligence) and the types of activities or achievements that will satisfy those diligence obligations. Additionally,
our Project Company may or may not be required to obtain prior consent from the licensor to sublicense the invention. The license terms
of our Lead Projects are discussed in detail below.

Generally speaking, pharmaceutical
development consists of preclinical and clinical phases. The preclinical phase can further sub-divided into the following stages:

  Target Identification & Selection: The target is the naturally existing cellular or modular structure that appears to have an important role in a particular disease pathway and will be targeted...  

  Lead Discovery: Following “ Target Identification & Selection,” compound screening assays are developed as part of the Lead Discovery. ‘ Lead’ molecules can mean slightly different things to di...  

  Lead Optimization: In this stage of the drug discovery process, the aim is to produce a preclinical drug candidate by maintaining the desired and favorable properties in the lead compounds, whi...  

  CTA-Enabling Studies: Includes all the essential studies such as GLP toxicology studies, pharmacology and efficacy, pharmacokinetics, in vitro metabolism, CMC studies, and the data of which are...  

  IND-Enabling Studies: Includes all the essential studies such as GLP toxicology studies, pharmacology and efficacy, pharmacokinetics, in vitro metabolism, CMC studies, and the data of which are...  

  In vitro validation: At this stage, the efficacy and safety of a drug candidate are assessed at cellular levels.  

  In vivo validation: At this stage, the efficacy, safety and pharmac