Aptorum Announces Publication of a Co-authored Paper on Development and Validation of a Sensitive Liquid Chromatography with Time-Of-Flight Mass Spectrometry Assay for In Vivo Pharmacokinetic Study of Epigallocatechin-gallate octaacetate (Pro-EGCG)

Regulatory News:

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) a clinical stage biopharmaceutical company dedicated to tackling unmet medical needs in oncology, autoimmune diseases and infectious diseases, is pleased to announce the recent publication of a joint effort for the validated analytical method developed for the determination of plasma pro-EGCG and its metabolites after oral administration using ultra performance liquid chromatography coupled to quadrupole time of flight mass spectrometry. This method was shown to be robust, rapid and sensitive which is a prerequisite for conducting in vivo pharmacokinetic studies.

The paper is titled, “Determination of (-)-epigallocatechin-3-gallate octaacetate and its metabolites in plasma of rats for pharmacokinetic study by ultra-performance-liquid-chromatography coupled to quadrupole-time-of-flight-mass-spectrometry” has been published in Frontiers in Pharmacology which can be downloaded at the following website address: https://pubmed.ncbi.nlm.nih.gov/36304154/.

Dr Thomas Lee, Head of Research and Development of Aptorum Group commented, “We are pleased to have this assay developed by The Chinese University of Hong Kong via our collaboration. Pro-EGCG is a prodrug of EGCG via octa-acetylation. As expected, it will be metabolized in multiple steps to EGCG and therefore monitoring of these metabolites at the same time is a major challenge. Heartfelt thanks to our collaborators, especially Prof. Ronald Chi Chiu Wang, at The Chinese University of Hong Kong, their hard work has translated to a sensitive, robust LC/MS assay which can monitor multiple Pro-EGCG and its metabolites in the plasma. Developing a sensitive assay is a necessary step before conducting in vivo IND-enabling studies such as GLP-compliant pharmacokinetic and toxicokinetic studies. We believe the same assay can be further optimized for eventual Phase 1 clinical trials in humans.”

About Aptorum’s Pro-EGCG Program

Pro-EGCG is a novel small molecule designed for oral administration as a potential non-hormonal based treatment for Endometriosis. The endometriosis condition is a painful disorder where the endometrial tissue grows outside the uterus, potentially affecting ovaries, fallopian tubes and pelvis tissue, in severe cases affecting fertility. It has been estimated that endometriosis affects c. 10% of reproductive age women and girls according to the World Health Organisation¹.

^{1. https://www.who.int/news-room/fact-sheets/detail/endometriosis#:~:text=Endometriosis%20affects%20roughly%2010%25%20(190,and%20girls%20globally%20(2).}

About Aptorum Group

Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) is a clinical stage biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutic assets to treat diseases with unmet medical needs, particularly in oncology (including orphan oncology indications), autoimmune and infectious diseases. Aptorum has completed two phase I clinical trials for its ALS-4 (MRSA) and orphan drug designated SACT-1 (Neuroblastoma) small molecule drugs and commercializing its NLS-2 NativusWell^® nutraceutical (menopause). The pipeline of Aptorum is also enriched through (i) the establishment of drug discovery platforms that enable the discovery of new therapeutics assets through, e.g. systematic screening of existing approved drug molecules, and microbiome-based research platform for treatments of metabolic diseases; and (ii) the co-development and ongoing clinical validation of its novel molecular-based rapid pathogen identification and detection diagnostics technology with Singapore’s Agency for Science, Technology and Research.

For more information about the Company, please visit www.aptorumgroup.com.

Disclaimer and Forward-Looking Statements

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This press release includes statements concerning Aptorum Group Limited and its future expectations, plans and prospects that constitute “forward-looking statements” within the meaning of the US Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue,” or the negative of these terms or other similar expressions. Aptorum Group has based these forward-looking statements, which include statements regarding projected timelines for application submissions and trials, largely on its current expectations and projections about future events and trends that it believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions including, without limitation, risks related to its announced management and organizational changes, the continued service and availability of key personnel, its ability to expand its product assortments by offering additional products for additional consumer segments, development results, the company’s anticipated growth strategies, anticipated trends and challenges in its business, and its expectations regarding, and the stability of, its supply chain, and the risks more fully described in Aptorum Group’s Form 20-F and other filings that Aptorum Group may make with the SEC in the future, as well as the prospectus that received the French Autorité des Marchés Financiers visa n°20-352 on 16 July 2020. As a result, the projections included in such forward-looking statements are subject to change and actual results may differ materially from those described herein.

Aptorum Group assumes no obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

This announcement is not a prospectus within the meaning of the Regulation (EU) n°2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n°2019/980 of 14 March 2019 and n°2019/979 of 14 March 2019.

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