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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K 

  

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of June 2022

 

Commission File Number: 001-38764

  

APTORUM GROUP LIMITED

 

17 Hanover Square

London W1S 1BN, United Kingdom

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:   Form 20-F ☒   Form 40-F ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

 

 

 

We are filing this report to disclose certain power point presentations the Company shares with potential business partners; such presentations are incorporated herein by reference.

Neither this report nor the exhibits constitute an offer to sell, or the solicitation of an offer to buy our securities, nor shall there be any sale of our securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

 

The information in this Form 6-K, including the exhibits shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

This Form 6-K is hereby incorporated by reference into the registration statements of the Company on Form S-8 (Registration Number 333-232591) and Form F-3 (Registration Number 333-235819) and into each prospectus outstanding under the foregoing registration statements, to the extent not superseded by documents or reports subsequently filed or furnished by the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.

 

EXHIBIT INDEX

 

Exhibit No.

  

Description

99.1   Power Point Presentation
99.2   Power Point Presentation

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  Aptorum Group Limited
     
Date: June 9, 2022 By: /s/ Sabrina Khan
    Name:  Sabrina Khan
    Title: Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited Facilitating Life Science Innovations to Serve Unmet Medical Needs SMART - ACT Ρ - ORPHAN DRUG DEPURPOSING PLATFORM ALS - 4 Non - confidential Overview

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 2 Disclaimer This document includes statements concerning Aptorum Group Limited and its future expectations, plans and prospects that constitute “forward - looking statements” within the meaning of the 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 suc h 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, trials and commercialization and market potential of related products, 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 document 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 a result, the projections included in such forward - looking statements are subject to change and results may differ materially from those disclosed herein . Aptorum Group assumes no obligation to update any forward - looking statements contained in this document as a result of new information, future events or otherwise . THIS PRESENTATION DOES NOT CONSTITUTE AN OFFER TO SELL OR SOLICITANT OFFER TO BUY NEITHER SHALL THERE BE ANY SALE OF THESE SECURITIES IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH STATE .

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Staphylococcus aureus are gram - positive bacteria and the leading cause of skin and soft tissue infections, but can cause serious infections such as pneumonia, bacteraemia, and bone infections • Vancomycin is the most frequently prescribed treatment for methicillin - resistant Staphylococcus aureus (MRSA); however, vancomycin has been >60 years in use and has been shown to have slow bactericidal activity, poor anti - staphylococcal activity, poor tissue penetration, high rates of infection relapse, and can cause resistance (vancomycin - intermediate (VISA) and vancomycin - resistant ( VRSA )) 4 • MRSA (pneumonia) mortality rate is between 30% - 55.5% 2, 3 • MRSA (skin and soft tissue) recurrence rate is approximately 70% 2,3 • New efficacious and safe therapeutics are urgently needed MRSA, VRSA and VISA are ranked as “high priority” development targets by the World Health Organisation 1 3 Antibiotic - resistant Staphylococcus aureus infections represent a significant unmet need 1. https://www.who.int/news - room/detail/27 - 02 - 2017 - who - publishes - list - of - bacteria - for - which - new - antibiotics - are - urgently - needed 2. "Methicillin - resistant Staphylococcus Aureus (MRSA) Drugs Market - Global Industry Analysis, Size, Share, Growth, Trends, an d Forecast, 2017 - 2025“ (2018) https://www.researchandmarkets.com/reports/4851384/methicillin - resistant - staphylococcus - aureus - drugs . Transparency market research; 3. Clin Infect Dis. 2006 Jan 1;42 Suppl 1:S5 - 12; 4 . https ://pubmed.ncbi.nlm.nih.gov/25401098/ Image: CDC.gov

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Developing non - antibiotics (non - bactericidal and non - bacteriostatic ). • Targeting virulence factors to disarm bacteria and thereby reducing pathogenicity . • Potentially less selective pressure and much less likely for bacteria to develop resistance . 4 The Aptorum approach: Combating emerging antibiotic resistance

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited Antibiotics 5 ALS program: Value proposition 1. Refer to “ALS - 4: Approved Drugs for MRSA Infections” for complete set of sources; 2. P T. 2016 Feb; 41(2): 126 – 128; 3. J Infe ct Dis. 2018 Jan 30;217(4):628 - 636; 4. Based on Aptorum's internal tests/experimentation and has not yet been verified by clinical trials or third party testing; 5. MBio . 2017 Sep 5;8(5). pii : e01224 - 17; 6. J Exp Med. 2005 Jul 18;202(2):209 - 15. Antibiotic Anti - virulence x Not bactericidal, potentially less selective pressure and much less likely for bacteria to develop resistance 4,5 x "Disarms" the bacteria by reducing pathogenicity 4,5,6 x Bacterial clearing is mediated by host immunity 4,5 Directed against pathogen Anti - virulence • Antibiotic resistance in S. aureus has been discovered in most prescribed antibiotics for MRSA 1 • Broad spectrum and indiscriminate 2 • Commonly affect normal flora, may lead to superinfection in case of drug resistance 3 Indiscriminate clearance

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Bacterial infections are mediated by pathogenic or opportunistic bacteria • Successful infections depends on host immunity and the pathogen’s virulence • Virulence factors are the molecules that assist the bacteria to colonize the host at the cellular level; these factors are either secretory, membrane associated or cytosolic in nature • Gram positive bacteria ( e.g , Staphylococcus aureus) rely heavily on multiple arrays of virulence factors • Targeting bacterial virulence is an alternative approach to antimicrobial therapy 6 ALS program: Value proposition The figure is modified from Rachel J. Gordon, et al. Clin Infect Dis. (2008) Inflammation Capsule Inhibit phagocytosis Staphyloxanthin

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Novel mechanism: Anti - virulence, non - bactericidal approach as it targets virulence properties of S. aureus • Oral form : An orally administered small molecule in line with “IV to oral antibiotic” switch policies; therefore, it has the potential fo r increased cost - effectiveness through out - patient treatment • Potential as a mono - or combination therapy to overcome the shortcomings of vancomycin • ALS - 4 can potentially complement other bactericidal antibiotics as well; therefore, ALS - 4 is not a direct competitor to antibiot ics • Potentially shows synergistic effects with other antibiotics ALS - 4 is a first - in - class, oral therapeutic that has the potential to complement vancomycin 7 ALS - 4, an anti - virulent, non - bactericidal drug candidate for S. aureus infections incl. MRSA Centers for Disease Control and Prevention. https://www.cdc.gov/hai/settings/lab/vrsa_lab_search_containment.html Desirable Characteristics ALS - 4 Vancomycin Anti - virulent ✓ ✗ Non - bactericidal ✓ ✗ (Inhibits transpeptidation by binding to D - alanyl - D - alanine residues of the bacterial cell wall, leading to cell wall decomposition and bacterial lysis) No observed resistance ✓ ✗ (Vancomycin - resistant S. aureus discovered in 2002 1 ) Orally bioavailable ✓ ✗ (Oral only for gastrointestinal infection) Good tissue penetration ✓ ✗ (Large molecule)

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Neutrophils kill bacteria including Staphylococcus aureus intracellularly or extracellularly via Reactive Oxygen Species: ROS - oxygen radicals released by neutrophils trigger the subsequent bacterial damage processes. 1 • To counteract, staphyloxanthin , a carotenoid pigment, protects the bacteria by serving as an anti - oxidant to neutralize the ROS secreted by neutrophils. 1 8 The role of staphyloxanthin in Staphylococcus aureus 1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5975594/ Neutrophil

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • ALS - 4 inhibits a key enzyme in the biosynthesis of staphyloxanthin. 1 In the absence of staphyloxanthin , the bacteria become susceptible to damage by ROS, triggering the usual series of mechanisms by neutrophils that ultimately leads to bacterial cell death. • ALS - 4 also shown that in the absence of staphyloxanthin , bactericidal activity is enhanced in the presence of antibiotics such as Vancomycin 2 . 9 Mechanism of action: Targeting staphyloxanthin synthesis of Staphylococcus aureus 1 1. Figure adapted from MBio . 2017 Sep 5;8(5). pii : e01224 - 17. 2 The description of ALS - 4 and related conclusory statements on ALS - 4 on this slide are based on Aptorum’s internal tests/experimentat ion and has not yet been verified by clinical trials or third party testing. ALS - 4 inhibits a key enzyme in the biosynthesis of staphyloxanthin 1

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited ALS - 4 • Inhibits S. aureus pigment production ( staphyloxanthin ) with an IC 50 = 20nM. • This is visibly confirmed by the decolorization of the bacteria as ALS - 4 is administered with increasing concentrations from 3.1 to 200nM. 10 Inhibition of staphyloxanthin synthesis by ALS - 4 Figure adapted from MBio . 2017 Sep 5;8(5). pii : e01224 - 17. DMSO control ALS - 4 200nM 100nM 50nM 25nM 12.5nM 6.3nM 3.1nM

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited ALS - 4 inhibits the production of staphyloxanthin in 11 common strains of S. aureus in vitro 11 ALS - 4 effectively inhibits staphyloxanthin formation across 11 strains of S. aureus 1 The description of ALS - 4 and related conclusory statements on ALS - 4 on this slide are based on Aptorum’s internal tests/experimentation and has not yet been verified by clinical trials or third party testing. Pigment production ratio ALS - 4 concentration ( nM ) (log 10 scale) Strain Type IC 50 ( nM ) SH1000 MSSA 70.5 ± 6 HG003 MSSA 54.4 ± 4 USA300 - JE2 MSSA 37.7 ± 4 USA300 (FPR - 3757) CA - MRSA 30.8 ± 5 USA300 - 3 HA - MRSA 42.8 ± 6 Newman MSSA 23.7 ± 1 USA300 - LAC MRSA 43.6 ± 5 ATCC29213 MSSA 30.0 ± 5 Clinical isolate ST239III HA - MRSA 16.3 ± 8 Mu3 VISA 2.6 ± 1 COL HA - MRSA 0.9 ± 1 ALS - 4 can inhibit staphyloxanthin production in major MRSA strains and also VISA and MSSA strains. ALS - 4 can address and compensate suffering from vancomycin resistant strains of staphylococcus aureus due to the targeting of different mechanisms 1 .

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Lack of direct selection pressure significantly decreases the risk of emergence of drug resistance. • In the absence of neutrophils, ALS - 4 does not inhibit growth in 5 strains of S. aureus (left) and 5 different species of bacteria (right). However, ALS - 4 reduces the virulence factors of S. aureus, significantly reducing risks of mortality and morbidity. 12 ALS - 4 does not directly inhibit bacterial growth in vitro ALS - 4 ALS - 4 The description of ALS - 4 and related conclusory statements on ALS - 4 on this slide are based on Aptorum’s internal tests/experimentation and has not yet been verified by clinical trials or third party testing.

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • ALS - 4 reduces bacteria number by an additional 10 - fold in the presence of hydrogen peroxide (mimicking ROS production by neutrophils), as demonstrated in the below graph (p<0.001). 13 ALS - 4 increases sensitivity of S. aureus to oxidative damage Control ALS - 4 (2µM) Statistical significance (p < 0.05) was assessed with unpaired student t - test. * p < 0.05, ** P < 0.01, *** P < 0.001, **** P < 0.0001. The description of ALS - 4 and related conclusory statements on ALS - 4 on this slide are based on Aptorum’s internal tests/experimentation and has not yet been verified by clinical trials or third party testing.

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 14 ALS - 4 enhances neutrophil killing of MRSA Bacterial density following treatment with human neutrophils in ALS - 4 or vehicle treated MRSA (strain COL). Data is presented as mean ± SEM. Statistical significance (p < 0.05) was assessed with unpaired student t - test. * p < 0.05, ** P < 0.01, *** P < 0.001, **** P < 0.0001. ALS - 4 The description of ALS - 4 and related conclusory statements on ALS - 4 on this slide are based on Aptorum’s internal tests/experimentation and has not yet been verified by clinical trials or third party testing.

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • A lethal dose (10 9 CFU) of MRSA was introduced through the tail vein • ALS - 4 was administered orally 30 minutes after infection for twice a day thereafter Oral administration of ALS - 4 in a lethal MRSA (USA300) survival in vivo model. 15 ALS - 4 rescues rats infected with a lethal dose of MRSA in a bacteremia model Survival (%) Time (d) Vehicle (N=9) ALS - 4 (10mg/kg) (N=9) 55.6% 0% p = 0.013 The description of ALS - 4 and related conclusory statements on ALS - 4 on this slide are based on Aptorum’s internal tests/experimentation and has not yet been verified by clinical trials or third party testing.

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Rats were challenged with a non - lethal dose (10 7 CFU) of MRSA through the tail vein • In order to simulate a more realistic clinical scenario, treatment was introduced 14 - days after infection, where ALS - 4 was administered orally twice a day at 10mg/kg per animal for 7 days • Please see appendix for results in kidney, lung, liver, spleen in comparison to vancomycin Oral administration of ALS - 4 in a non - lethal bactaremia in vivo model. 16 ALS - 4 greatly reduces organ bacterial count in a bacteremia animal model 99.5%reduction Kidney bacterial count (CFU/g) (log 10 scale) 10 4.8 = 63,096 CFU/g ALS - 4 (10mg/kg) (N=8) 10 2.5 = 316 CFU/g p=0.01 Control (N=8) The description of ALS - 4 and related conclusory statements on ALS - 4 on this slide are based on Aptorum’s internal tests/experimentation and has not yet been verified by clinical trials or third party testing.

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 17 Vehicle ALS - 4 Van ALS + Van Vehicle ALS - 4 Van ALS + Van The description of ALS - 4 and related conclusory statements on ALS - 4 on this slide are based on Aptorum’s internal tests/experimentation and has not yet been verified by clinical trials or third party testing.

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • No effect on the MIC of vancomycin was observed in vitro when the concentration of ALS - 4 was below 25µM • ALS - 4 is targeted to be efficacious at between 20 - 30nM, well within the above range. ALS - 4 does not affect the minimum inhibitory concentration (MIC) of vancomycin in 8 strains of S. aureus. 18 ALS - 4 does not interfere with the action of vancomycin in - vitro ALS - 4 ( uM ) ALS - 4 ( uM ) ALS - 4 ( uM ) ALS - 4 ( uM ) ALS - 4 ( uM ) ALS - 4 ( uM ) ALS - 4 ( uM ) ALS - 4 ( uM ) The description of ALS - 4 and related conclusory statements on ALS - 4 on this slide are based on Aptorum’s internal tests/experimentation and has not yet been verified by clinical trials or third party testing.

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Clindamycin resistance (MIC from 0.12 μg /ml to >5 μg /ml) appeared rapidly after a 10 - day intermittent treatment • The use of Ery was to ensure no contamination of environmental bacteria as USA 300 (LAC) is resistance Ery • Controls without the addition of antibiotics showed no resistance to clindamycin • For the full protocol, please see appendix Pre - treatment 19 ALS - 4 does not trigger antibiotic resistance in MRSA Tubes Day 1 - 4 Day 6 - 10 1 DMSO DMSO 2 Ery 16 + CLI 0.12 µg/ml Ery 16 3 ALS - 4 1µM ALS - 4 1µM (Clindamycin withdrawn between day 5 - 10) Clindamycin resistance test after pre - treatment (BHI medium with 5 x 10 4 /well bacterial inoculum) Concentration of Clindamycin (;g/ml) R e l a t i v e g r o w t h 0.01 0.1 1 0.0 0.5 1.0 ALS-4-1uM Ery16-Cli0.12;g/ml DMSO The description of ALS - 4 and related conclusory statements on ALS - 4 on this slide are based on Aptorum’s internal tests/experimentation and has not yet been verified by clinical trials or third party testing.

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited No bacterial resistance to ALS - 4 detected after continuous incubation of the bacteria in the presence of 1μM ALS - 4 for 11 days. 20 ALS - 4 does not trigger its own resistance Recovered bacteria after 11 - day resistance - raising with 1μM ALS - 4ca BHI agar plates Recovered bacteria after 11 - day resistance - raising with DMSO as control Concentration of ALS-4 (nM) R e l a t i v e p i g m e n t p r o d u c t i o n 10 100 0.0 0.2 0.4 0.6 0.8 ALS-4-1;M DMSO Ery16-Cli0.12;g/ml Concentration of ALS-4 (nM) R e l a t i v e p i g m e n t p r o d u c t i o n 10 100 0.0 0.2 0.4 0.6 0.8 ALS-4-1;M DMSO Ery16-Cli0.12;g/ml 100nM ALS - 4 (all colonies turned white) No ALS - 4 (all colonies remained yellow) ALS - 4 efficacy test (Bacterial inoculum: 4 x 10 7 /ml) The description of ALS - 4 and related conclusory statements on ALS - 4 on this slide are based on Aptorum’s internal tests/experimentation and has not yet been verified by clinical trials or third party testing.

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Only 1 physical form identified from polymorph screening • Physically and chemically stable • Not hygroscopic 21 ALS - 4: chemistry, manufacturing and controls (CMC) ALS - 4 is an attractive candidate for formulation • GLP toxicology batch of API has been completed • GMP manufacturing of API has been completed • GMP manufacturing of drug product has been completed for Phase 1 API (active pharmaceutical ingredient) manufacturing • Developed an enabling formulation to improve bioavailability • An oral liquid formulation was used in Phase 1 clinical trial ALS - 4 has low solubility in water

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited Phase 1 trial in Canada (Completed) A randomized, double - blind, placebo - controlled, dose - escalation study to assess the safety, tolerability, and pharmacokinetics of single (SAD) and multiple ascending doses (MAD) of ALS - 4 administered orally to healthy male and female adult volunteers 22 A P1 dose - escalation study in healthy volunteers is currently ongoing with positive interim results Aptorum Group has announced completion of the trial • No subjects from both SAD and MAD cohorts dropped out of the studies and no Serious Adverse Events were observed • In addition, no clinically relevant changes in respect of vital signs, electrocardiogram, clinical laboratory test results an d physical examinations were observed compared to baselines Healthy adult volunteers (N=72) SAD • 25 mg • 50 mg • 100 mg • 200 mg • 300mg MAD • 50 mg • 100mg • 200mg The Phase 1 Trial completed in Q4, 2021

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 23 ALS - 4: Targeted Clinical development Phase 1 (Canada; completed) Phase 2 (US) (under planning) Registrational study (future) Filing An unmet, orphan indication will also be selected to enable NDA filing via the US LPAD ( Limited population pathway for antibacterial and antifungal drugs) SUBMISSION A randomized, double - blind, placebo - controlled, dose - escalation study with oral ALS - 4 Outcomes : Safety, tolerability, and pharmacokinetics of SAD and MAD of oral ALS - 4 Population : Healthy adult volunteers (N=72) A randomized, double - blind study with ALS - 4 in combination with SOC compared to SOC alone Outcomes: Safety, efficacy, microbiologic eradication Population: Adults with MRSA bacteraemia or skin or soft tissue infections who failed to respond to initial SOC treatment (culture positive) or with clinical responses A randomized, double - blind study with ALS - 4 in combination with vancomycin compared to vancomycin alone Outcomes: Safety, efficacy, microbiologic eradication Population : Adults with MRSA bacteraemia or skin and soft tissue infections who failed to respond to initial vancomycin treatment (culture positive) or with clinical responses

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • The global methicillin - resistant Staphylococcus aureus drugs market was valued at approximately US$ 2.9 Bn in 2016 and projected to each over US$ 3.9 Bn by 2025 1 24 Market opportunities 1. "Methicillin - resistant Staphylococcus Aureus (MRSA) Drugs Market - Global Industry Analysis, Size, Share, Growth, Trends, and Fo recast, 2017 - 2025“ (2018). US LPAD opportunities Key indications ‘Blue Sky’ opportunities ALS - 4 in combination with SOC for MRSA (bacteraemia, pneumonia, skin & soft tissue, bone & joint, endocarditis) A small subset of the key indications, for example, kidney failure patients suffering from MRSA bacteraemia, chronic MRSA bacteraemia, etc. ALS - 4 monotherapy as an outpatient prophylactic treatment in high risk population (e.g. aged patients undergoing surgery) ALS - 4 market opportunities

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • The patent and patent applications cover the composition of small molecule compound and the method of treating microbial infection using same mechanism 25 ALS - 4: IP status ALS - 4 Patent Family Compound / Composition Method of Treatment Formulation / CMC Dosage Physical Form Other (e.g. Combination treatment or special route of administration) Status Granted* Granted* Planned for filing Not yet filed Not yet filed Not yet filed Expiration date N/A N/A N/A N/A N/A N/A Region and term *Patents have been granted in the U.S. (US Pat. No. 11,040,949 and US Pat. No. 11,052,078 titled “Compounds Affecting Pigment Production and Methods for Treatment of Bacterial Diseases”). National applications based on PCT application (PCT App. No. PCT/IB2018/055459) have been filed in major jurisdictions and regions including EP, China, Australia, Brazil, Canada, Chile, Eurasia, Israel, Japan, Malaysia, New Zealand, Singapore, Sout h K orea and Hong Kong (all pending). ** The U.S. patents will expire in 2038, while any national patents based on the PCT application, if granted, will have a 20 - ye ar patent term from 2018.

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited APPENDIX

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Approved drugs for MRSA infections Frequently prescribed antibiotics for MRSA infections 1 27 Approved drugs for MRSA Infections Product (Company) Antibiotic Class Indication(s) RoA Dose Cost of Treatment (duration) Notes Vancomycin (Generic) Glycopeptide Severe infections caused by MRSA IV / oral* 2g/day USD 101 - 144 (7 - 10 days) • Currently, the most frequently prescribed antibiotic for MRSA suspected infections 1,2 • In clinical use for >60 years 3 , vancomycin - resistant S. aureus (VRSA) was first discovered in 2002 4 Daptomycin (Merck) Lipopeptide ABSSSI, S. aureus bacteraemia IV 4 - 6mg/kg/day USD 6,736 - 23,710 5 (14 - 42 days) • In clinical use since 2003 6 • Daptomycin resistance described in S. aureus as early as 2006 7 Linezolid (Pfizer) Oxazolidinone ABSSSI, CABP, HABP, uSSSI IV / oral 0.8 - 1.2g/day IV: USD 1,920 - 5,376 Oral: USD 2,978 - 11,429 (10 - 14 days) • In clinical use since 2003 8 . Entirely synthetic, not expected to develop clinical resistance 9 , however • Linezolid resistance encountered clinically since 2010 9 Ceftaroline fosamil (Actavis) Cephalosporin ABSSSI, CABP IV 1.2g/day USD 1,831 - 5,127 (5 - 14 days) • In clinical use since 2010 10 • Ceftaroline resistance encountered clinically since 2016 11 Tigecycline (Pfizer) Glycycycline ABSSSI, CABP, CIAI IV 0.1 - 0.2mg/day USD 1,888 - 4,977 (5 - 14 days) • In clinical use since 2005 12 • Tigecycline resistance encountered clinically in developing countries since 2017 13,14 Televancin ( Theravance Biopharma) Lipoglycopeptide ABSSSI, HABP, VABP IV 10mg/kg/day USD 3,002 - 10,568 (7 - 21 days) • In clinical use since 2009 15 • Vancomycin resistance leads to a 4 - 8x increase in telavancin MIC (minimum inhibitory concentration) 16 ABSSSI: acute bacterial skin and skin structure infection; CABP: community - acquired bacterial pneumonia; HABP: hospital - acquired bacterial pneumonia; CIAI: complicated intra - abdominal infection; VABP: ventilator - associated bacterial pneumonia; * Only for intestinal infections; 1. Reproduced from“ Companies Take Aim at MRSA Infections” P T. 2016 Feb; 41(2): 126 – 128; 2. Clin Infect Dis. 2011 Feb 1;52(3):e18 - 55; 3. Clin Infect Dis. 2006 Jan 1;42 Suppl 1:S5 - 12; 4. Centers for Disease Control and Prevention. https://www.cdc.gov/hai/settings/lab/vrsa_lab_search_containment.html; 5. Cost of treatment of Daptomycin for S. aureus bacteremia at a dosage of 6mg/kg; 6. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21 - 572_Cubicin.cfm; 7. Int J Antimicrob Agents. 2006 Oct;28(4):280 - 7; 8. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21 - 130s003_21131s003_21132s003_Zy voxTOC.cfm; 9. Pharmaceuticals (Basel). 2010 Jul; 3(7): 1988 – 2006; 10. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200327orig1s000toc.cfm; 11. J Antimicrob Chemother. 2016 Jun; 71(6): 1736 – 1738; 12. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21 - 821_Tygacil.cfm; 13. New Microbes New Infect. 2017 Sep; 19: 8 – 12; 14. Journal of Microbiology and Infectious Diseases 2017; 7 (4):173 - 177; 15.FDA. https://www.accessd ata.fda.gov/drugsatfda_docs/nda/2009/022110s000TOC.cfm; 16. Clin Infect Dis. 2015 Sep 15;61 Suppl 2:S58 - 68. The only 2 FDA approved antibiotics for MRSA bacteraemia

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Dose - dependent efficacy of ALS - 4 ( compound IM032) shows a statistically significant reduction in bacteria count across major organs relative to vancomycin as a control. The results shown in this slide are based on Aptorum's internal (in vitro/in vivo) tests/experiments that have not been verif ied in clinical trials and/or third party testing 28 ALS - 4: Oral administration in a MRSA non - lethal bacteraemia mouse model Kidney CFU count L o g ( C F U / g ) K i d n e y I n i t i a l c o u n t , 1 h r V e h i c l e , P O , B I D x 7 d V a n c o m y c i n , 3 m g / k g , I V , Q D x 7 d I M 0 3 2 , 3 0 m g / k g , P O , B I D x 7 d I M 0 3 2 , 1 0 m g / k g , P O , B I D x 7 d I M 0 3 2 , 3 m g / k g , P O , B I D x 7 d I M 0 3 2 , 1 m g / k g , P O , B I D x 7 d I M 0 3 2 , 0 . 3 m g / k g , P O , B I D x 7 d 0 2 4 6 * Lung CFU count L o g ( C F U / g ) L u n g I n i t i a l c o u n t , 1 h r V e h i c l e , P O , B I D x 7 d V a n c o m y c i n , 3 m g / k g , I V , Q D x 7 d I M 0 3 2 , 3 0 m g / k g , P O , B I D x 7 d I M 0 3 2 , 1 0 m g / k g , P O , B I D x 7 d I M 0 3 2 , 3 m g / k g , P O , B I D x 7 d I M 0 3 2 , 1 m g / k g , P O , B I D x 7 d I M 0 3 2 , 0 . 3 m g / k g , P O , B I D x 7 d 0 1 2 3 4 5 *** *** * * Liver CFU count L o g ( C F U / g ) L i v e r I n i t i a l c o u n t , 1 h r V e h i c l e , P O , B I D x 7 d V a n c o m y c i n , 3 m g / k g , I V , Q D x 7 d I M 0 3 2 , 3 0 m g / k g , P O , B I D x 7 d I M 0 3 2 , 1 0 m g / k g , P O , B I D x 7 d I M 0 3 2 , 3 m g / k g , P O , B I D x 7 d I M 0 3 2 , 1 m g / k g , P O , B I D x 7 d I M 0 3 2 , 0 . 3 m g / k g , P O , B I D x 7 d 0 2 4 6 * * **

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 1. Inoculum preparation: USA300 - 3 (LAC) was cultured overnight in BHI broth at 37˚C, 250 rpm. 2. Subculture preparation: 60 µl overnight culture was added to 6 ml BHI broth with different drugs. 3. Clindamycin (CLI): 0.12 µg/ml; Erythromycin ( Ery ): 16 µg/ml; ALS - 4: 1 µM. The use of Ery was to ensure no contamination of environmental bacteria as USA 300 (LAC) is resistance Ery . 4. Culturing: during culturing, medium was changed everyday by centrifugation of the bacteria and replacing the supernatant with new medium plus DMSO or antibiotics or compounds as specified. 5. Bacteria collection: on day 11, 1 ml bacteria was centrifuged and resuspended in PBS with 10% DMSO for further testing. 6. MIC testing: in BHI medium in 96 - well plate and cultured for 16h 7. Pigment production: in 96 deep - well plate and cultured for 36 h Protocol 29 ALS - 4 and drug resistance The results shown in this slide are based on Aptorum's internal (in vitro/in vivo) tests/experiments that have not been verif ied in clinical trials and/or third party testing Tubes Day 1 - 4 Day 6 - 10 1 DMSO DMSO 2 Ery 16 + CLI 0.12 µg/ml Ery 16 3 ALS - 4 1µM ALS - 4 1µM

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 30

 

Exhibit 99.2

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited Facilitating Life Science Innovations to Serve Unmet Medical Needs SMART - ACT Ρ - ORPHAN DRUG DEPURPOSING PLATFORM SACT - 1 Nonconfidential Overview

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited This document includes statements concerning Aptorum Group Limited and its future expectations, plans and prospects that constitute “forward - looking statements” within the meaning of the 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 suc h 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, trials and commercialization and market potential of related products, 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 document 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 a result, the projections included in such forward - looking statements are subject to change and results may differ materially from those disclosed herein . Aptorum Group assumes no obligation to update any forward - looking statements contained in this document as a result of new information, future events or otherwise . THIS PRESENTATION DOES NOT CONSTITUTE AN OFFER TO SELL OR SOLICITANT OFFER TO BUY NEITHER SHALL THERE BE ANY SALE OF THESE SECURITIES IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH STATE . Disclaimer 2

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • SACT - 1 is a repurposed oral suspension in development a s an adjunctive therapy to standard of care in relapsed or refractory high - risk neuroblastoma in pediatric patients. • SACT - 1 targets the MEK5 - ERK5 pathway and demonstrated to suppress MYCN expression, a poor prognostic factor of therapeutic outcome and resistance in neuroblastoma. • SACT - 1 has demonstrated remarkable potential in enhancing tumor cell death through different pathways. • Preclinically, in combination with standard chemotherapy, SACT - 1 provided enhanced efficacy in a xenograft mouse model of neuroblastoma. We propose the novel application of SACT - 1 as a new treatment option for extending survival in high - risk neuroblastoma. 3 Executive summary

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Our completed Phase 1 trial showed the safe use of SACT - 1. The distinctive PK between SACT - 1 and Edurant ® further strengthen the advantage of our product. • Aptorum is initiating an “End of Phase 1 (EOP1) Meeting” with the US FDA to seek approval to conduct a Phase 1b/2a trial. • Received FDA orphan designation for the treatment of neuroblastoma in Jan 2022. • Received in 2021 the first granted patent in treatment of various cancers including but not limited to neuroblastoma. 4 Executive summary (cont’d)

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited So far no approved products are available MEK5 and ERK5 as potential therapeutic targets for cancers in recent years

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • MEK5 - ERK5 pathway is reported to regulate MYCN oncogene expression (Kang et al., 2006; Umapathy et al., 2014; van Hoang et al., 2017) which is known to contribute to the poor prognosis of patients with neuroblastoma • Aptorum discovered SACT - 1 has a K D of 150 nM against MEK5 , well below the C SS in humans (290 nM to 1.5 µM at 25 mg to 150 mg QD), we proposed its use in modulation of the MEK5 - ERK5 pathway • To the best of our knowledge, SACT - 1 is the only potential drug candidate already in the market to downregulate MYCN expression through modulation of MEK5 - ERK5 pathway , thus the reproposed drug programme for relapsed/refractory neuroblastoma. 6 Proposed mode of action MEK5 ERK5 Mitogens and oncogenic signals Roles in cancer • Tumour cell proliferation and survival • EMT and metastasis • CSC - like traits • Therapy resistance • Immunosuppression • Angiogenesis SACT - 1 Transcription Regulators (e.g. MYCN) Kinases Cyclins & CDKi Cytokines & Growth factors

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 7 Targeted product profile Preclinical Toxicology Not relevant as this is a repurposed drug PK/PD Model To be determined in Phase 1b/2a trial CM&C Oral suspension with l ow complexity for production Dose/dose schedule RP2D will be determined in Phase 1b Half - life To be determined in Phase 1b/2a Trial Adverse Event Profile None of the subjects were discontinued from the study because of an adverse event. None of the adverse events experienced by sub jects was judged as serious Other AE Profile None Efficacy Profile To be determined in Phase 1b/2a Trial Health Outcome Improve progression free, and overall, survival in high - risk neuroblastoma patients Pharmacology SACT - 1 is proposed to modulate MEK5 - ERK5 pathway subsequently reducing the poor prognosis factor MYCN

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • ~ 700 cases of high - risk neuroblastoma patients each year in the US 3 and we estimated EU has 1.5x this number of cases, c. 1050 high risk neuroblastoma patients per year • Accounts for ~15% of all cancer - related deaths in the pediatric population 4 • SACT - 1 has gained FDA Orphan Drug Designation for the treatment of neuroblastoma in 2022. • Designated orphan drugs receive 7 years of market exclusivity in US and 10 years of marketing exclusivity in EU • Patents on new indication and reformulation of SACT - 1 , if granted, will provide up to 20 years of patent exclusivity from the application date in parallel to the market exclusivity # 1 Most common type of solid tumor in children 1 US $ 596.2 mil Value of the global neuroblastoma treatment market in 2020 2 5 .0 % MARKET SIZE PREVALENCE ORPHAN DRUG DESIGN A TION 5 Neuroblastoma - market overview 1. Pediatr Rev. 2018 Feb;39(2):57 - 67; 2. “ Pediatric Neuroblastoma Treatment Market size 2022: Sales, Price, Revenue, Gross Margin, News Product Launches, Upcoming Trend Analysis a nd Forecast 2027”(2022). Market Watch. 3. Curr Oncol Rep. 2009 Nov;11(6):431 - 8 4. Paediatr Drugs. 2011 Aug 1;13(4):245 - 55 5. https://www.fda.gov/about - fda/o ffice - special - medical - programs/office - orphan - products - development 8 CAGR global neuroblastoma treatment market (2021 - 2027) 2

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited Standard of care for high - risk neuroblastoma • Surgery • Chemotherapy • Radiotherapy • Immunotherapy (anti - GD2 monoclonal antibodies) o Dinutuximab beta ( Qarziba ) o Dinutuximab ( Unituxin ) o Naxitamab ( Danyelza ) 9 Application of SACT - 1 as a novel treatment option for neuroblastoma SACT - 1 uses a unique mechanism and works in combination with other therapies rather than competing or replacing the current therapy SACT - 1 works in combination with standard of care chemotherapy and / or new therapies for neuroblastoma. It downregulates MYCN expression through the MEK5 - ERK5 pathway and is proposed to enhance anti - tumor effect and reduce occurrence of drug resistance.

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 10 In vitro and in vivo efficacy In vitro • SACT - 1 demonstrated inhibition of all tested neuroblastoma cell lines (IMR - 32, SK - N - BE(2), SK - N - SH, SH - SY5Y) • In combination with standard chemotherapy for neuroblastoma, SACT - 1 in general provides additive to synergistic efficacy 1 In vivo • Aptorum conducted mouse xenograft studies with a primary objective of assessing the efficacy of SACT - 1 alone, and with other chemotherapeutic agents: Combination Treatment Enhanced tumour shrinkage compared to monotherapy SACT - 1 + Cisplatin SOC First - line Treatment Yes SACT - 1 + Carboplatin SOC First - line Treatment Yes SACT - 1 + Vincristine SOC First - line Treatment Yes SACT - 1 + Irinotecan SOC for relapse Yes

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 11 In vivo efficacy - neuroblastoma xenograft studies in mice Cont’d SACT - 1 (RPV) dosed at 60 and 160 mg/kg (PO; daily x 21) potentiates the antitumor effects of vincristine (IP; QWK x3) in the neuroblastoma xenograft model IP = Intraperitoneal; PO = oral; QWK = weekly; RPV = SACT - 1; Vin = vincristine; CBP = carboplatin; * P < 0.05 The addition of SACT - 1 (RPV) (80 mg/kg; PO; daily x 21) demonstrated greater tumor volume reduction compared to irinotecan (80mg/ kg; IP; QWK x3) alone in the neuroblastoma xenograft model The addition of SACT - 1 (RPV) (160 mg/kg; PO; daily x 21) demonstrated greater tumor volume reduction compared to carboplatin (80mg/ kg; IP; QWK x3) alone in the neuroblastoma xenograft model

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • MYCN is involved in regulating various biological activities, such as apoptosis, proliferation, and angiogenesis in neuroblastoma (Huang and Weiss, 2013 ) and contributing to drug response • SACT - 1 at 150 to 1350 nM reduced MYCN protein levels in MYCN overexpressed neuroblastoma cell lines SK - N - BE( 2 ) and IMR - 32 12 Mechanistic studies – decrease of MYCN expression Decrease of MYCN Expression The effects of SACT - 1 on MYCN expression. Representative western blot analysis images of MYCN expression in response to SACT - 1 at 150 to 1350 nM for 2 and 24 hours in SK - N - BE(2) and IMR - 32 cells, respectively.

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • SACT - 1 was found to have a binding constant (K D ) of 150 nM against MEK 5 in a previous study by employing KdELECT Kinase Assay Panel • Expectedly, ERK 5 phosphorylation in IMR - 32 and SK - N - BE( 2 ) cells was decreased after SACT - 1 treatment for 2 hours at 150 nM to 1350 nM Mechanistic studies – ERK5 phosphorylation The effects of SACT - 1 on ERK 5 phosphorylation . Representative western blot analysis images of phospho - MEK 5 , MEK 5 , phospho - ERK 5 , and ERK 5 expressions in response to SACT - 1 at 150 to 1350 nM for 2 hours in MYCN overexpressed SK - N - BE( 2 ) and IMR - 32 cells . 13 Reduction of ERK5 Phosphorylation

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 14 Phase I study on bioavailability/ food effect Relative Bioavailability • Comparative bioavailability analysis between administration of SACT - 1 under fasted condition vs. fed condition and between SACT - 1 vs. Edurant ® tablets (both under fed conditions). • SACT - 1 fed dosing resulted in 90% increased AUC and 100% increased C max with respect to SACT - 1 fasted • Results of SACT - 1 vs Edurant ® showed ~40% higher exposure for AUC and 20% higher C max for SACT - 1 Safety • The study treatments in Phase 1 (administration of SACT - 1 under fasted and fed condition) were well tolerated: o All reported adverse events were considered grade 1 or “mild” and had an outcome of “resolved” o No subjects were discontinued from study participation because of adverse events o No serious adverse events were reported during the study. • The effect of study drug on the QTc interval is mild and remains within clinically acceptable limits PK parameter Fed condition (ref; n=14) Fasting condition (n=14) AUC 0 - tlast (ISCV) - 189.87% (15.4%) AUC 0 - ∞ (ISCV) - 189.43% (17.5%) C max (ISCV) - 205.25% (25.3%) PK of SACT - 1 administered under fed and fasting condition; Least - squares means for test to reference and associated variability PK parameter SACT - 1 (ref; n=14) Edurant ® tablets (n=14) AUC 0 - tlast (ISCV) - 139.01% (20.5%) AUC 0 - ∞ (ISCV) - 137.28% (21.8%) C max (ISCV) - 119.52% (29.1%) PK of SACT - 1 vs Edurant ® tablets administered under fed condition; Least - squares means for test to reference and associated variability

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited • Phase 1: Open - label, Randomized, 3 period, 3 - sequence, Single - dose Crossover Bioavailability and Food Effect Study of SACT - 1 and Edurant ® Tablets in Healthy Adult Volunteers ( NCT05358756 ) • Phase 1b/ 2a: A Multiple Ascending Dose Trial to Determine the Safety, Pharmacokinetic, and Activity of SACT - 1 as Adjunctive Therapy in Children with High - risk or Relapsed Neuroblastoma o Target engagement & modulation to be determined in this study o Location: US or other countries 15 Clinical Development Plan

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited Phase 1b/2a trial: Proposed Primary and Secondary Objectives Phase 1b Primary Objective • Evaluate the safety and tolerability of SACT - 1 in combination with chemotherapy • Determine recommended Phase 2 dose (RP2D) of SACT - 1 Secondary Objective • Characterize the pharmacokinetic (PK) profile of SACT - 1 Exploratory Objective • Evaluate preliminary activity of SACT - 1 Phase 2a Primary Objective • Evaluate antitumor activity of SACT - 1 in combination with chemotherapy as measured by objective response rate (ORR). • Evaluate the safety and tolerability of the RP2D of SACT - 1 in combination with chemotherapy Secondary Objective • Evaluate antitumor activity of SACT - 1 in combination with chemotherapy as measured by other parameters • Determine the PK characteristics of SACT - 1 when given in combination with chemotherapy Exploratory Objective • Evaluate biomarkers of response (MYCN) in participants treated with SACT - 1

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 17 Intellectual property Exclusive IP​ Title​ Country​ Application Date​ Expiration date​ Status​ Composition Including SACT - 1 and Method for Treating Tumors or Cancer US​ ​ 27 Nov 2020 27 Nov 2040​ ​ Granted ​ ​ Composition Including SACT - 1 and Method for Treating Tumors or Cancer US 5 Oct 2021 n/a Pending Composition Including SACT - 1 and Use for Treating Tumors or Cancer PCT 27 Nov 2020 n/a​ Pending o For PCT, national phase applications have been filed in Australia, Canada, China, EU, Indonesia, Japan, Korea, Malaysia and S ing apore

 

 

For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2022 Aptorum Group Limited 18