Niki BioSolutions, Inc. · NASDAQ:NIKI
Niki BioSolutions — Aptorum Group — Investor Presentation (March 2019)
36 slides from Niki BioSolutions's investor presentation, Mar 4, 2019
Slide 1: Corporate Presentation
OUR MISSION IS TO FACILITATE LIFE SCIENCE INNOVATIONS TO SERVE UNMET MEDICAL NEEDS Corporate Presentation NASDAQ Global Market: APM 1
Slide 2: Forward-looking statements
© Copyright 2019 Aptorum GroupLimited Certain information included in this presentation and other statements or materials published by Aptorum Group Limited (the “Company”) are not historical facts but are forward - looking statements. These forward - looking statements refer in particular to the Co
Slide 3: Aptorum Summary
A) Aptorum Group (Nasdaq: APM) is a Hong Kong based biopharmaceutical company currently with market capitalization over USD400m; B) Ma n agem e n t a n d b oar d o f d i rec t ors w i t h d ive r s e b a c k groun d and accomplishments in finance, healthcare industry; C) 12 technologies (from 11 exc
Slide 4: Executive management
MR. IAN HUEN Founder, Chief Executive Officer and Executive Director MR. DARREN LUI President, Chief Business Officer and Executive Director DR. CLARK CHENG Chief Medical Officer and Executive Director • Over 15 years in global asset management • US healthcare equity research analyst at Janus Hender
Slide 5: Project Portfolio: Drug and Device Candidates
PROJECT PORTFOLIO DRUG AND DEVICE CANDIDATES PROJECTS CANDIDATE / MODALITY INDICATION DEVELOPMENT STAGE Target I de nt i f i cat i on & Selection Lead D i sc o ve r y Lead Op ti m i za ti o n IND - Enabling Phase 1 Phase 2 Phase 3 VIDENS’ SERIES VLS - 1 Curcumin - MNP (Medical Imaging Agent for MRI
Slide 6: Project Portfolio
PROJECT PORTFOLIO PROJECTS CANDIDATE / MODALITY INDICATION DEVELOPMENT STAGE Target I de nt i f i cat i on & Selection Lead D i sc o ve r y Lead Op ti m i za ti o n IND - Enabling Phase 1 Phase 2 Phase 3 NATIVUS’ SERIES NLS - 1 Small molecule Treatment of Endometriosis NLS - 2 An extract from Chines
Slide 7: Overview of Our Lead Projects
OVERVIEW OF OUR LEAD PROJECTS ALS - 1 INFLUENZA A ALS - 4 STAPHYLOCOCCUS INCLUDING METHICILLIN - RESISTANT S. AUREUS (MRSA) NLS - 1 ENDOMETRIOSIS Population affected: Annual epidemics estimated to result in ~ 3 - 5 million cases of serious influenza infections, causing about 290 , 000 - 650 , 000 de
Slide 8: ALS-4: Treatment of Bacterial Infections including MRSA
ALS - 4 8 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2019 Aptorum GroupLimited Treatment of Bacterial Infections including MRSA by a Non - antibiotic Approach
Slide 9: ALS-4: Bacterial infection and virulence
ALS - 4 Inflammation C a p sule Inhibit phagocytosis • Bacterial infections are mediated by pathogenic or opportunistic bacteria • Successful infections depends on host’s immunity and pathogen’s virulence • Targeting bacterial virulence is an alternative approach to antimicrobial therapy 9 For illus
Slide 10: ALS-4: The Advantage of Targeting Virulence Expression
ALS - 4: THE ADVANTAGE OF TARGETING VIRULENCE EXPRESSION - DISARMING THE BACTERIA • Antibiotics are usually broad spectrum and indiscriminate • Commonly affect normal flora, may lead to super - infection in case of drug resistance Antibiotics Non - antibiotics A n tibiotics Non - antibiotics • Not b
Slide 11: The Mechanisms of ALS-4: Anti-Golden Pigment Agent
THE MECHANISMS OF ALS - 4 - ANTI - GOLDEN PIGMENT AGENT mBio (8(5): e01224, 2017)) • Staphyloxanthin is the golden yellow pigment of S. aureus • The pigment protects the bacteria against oxidative stress produced by our immune cells. • ALS - 4 is intended to suppress one of the key enzymes in the pi
Slide 12: In vivo and in vitro efficacy of ALS-4
in vivo AND in vitro EFFICACY OF ALS - 4 - PRELIMINARY ANIMAL SAFETY ALS - 4 is intended to inhibit S. aureus pigment production with an IC 50 = 20nM DMSO Control ALS - 4 200 nM 100 nM 50 nM 25 nM 12.5 nM 6.25 nM 3.13 nM ALS - 4 is observed to reduce bacterial load in mice C F U /K id n e y in lo g
Slide 13: Mechanism of ALS-2 and ALS-3
MECHANISM OF ALS - 2 AND ALS - 3 ALS - 2 is being developed to reduce virulence gene production ALS - 2 is intended to inhibit ClpP ALS - 2 is shown to rescue mice from S. aureus infection ADAPTED FROM: doi : 1 0. 1 073/ pna s . 1 720520 1 1 5 ALS - 3: An antibiotic - potentiating compound by using
Slide 14: Award winning concept at ICPIC in Geneva, 2017
AWARD WINNING CONCEPT AT ICPIC IN GENEVA, 2017 - NON - ANTIBIOTICS ANTI - VIRULENCE APPROACH This is the first time chemical genetics have been applied in an attempt to tackle MRSA infection . This revolutionary concept and discovery of the applications of chemical genetics, which forms the basis of
Slide 15: ALS-4 Preclinical Findings
ALS - 4 15 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. Preclinical Findings • MRSA has developed resistance to many, if not all, of the existing drugs available for treatment. • ALS - 4 employs a non - antibiotic approach designe
Slide 16: ALS-1: Treatment of Infections caused by Influenza A Viruses
ALS - 1 16 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2019 Aptorum GroupLimited Treatment of Infections caused by Influenza A Viruses via a Unique Therapeutic Target
Slide 17: ALS-1 findings
ALS - 1 • ALS - 1 acts on a unique therapeutic target, nucleoproteins, which distinguishes it from all other currently marketed antiviral drugs which currently experience resistance from Influenza A virus. • Inhibition of virus replication in vitro and outperforms oseltamivir (Tamiflu®) with a lower
Slide 18: NLS-1: Treatment of Endometriosis by a Non-hormonal Approach
NLS - 1 18 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2019 Aptorum GroupLimited Treatment of Endometriosis by a Non - hormonal Approach
Slide 19: Endometriosis
Endometrium outside the uterine cavity A chronic gynecological disorder affecting 10% of woman during reproductive ages with 176 million known cases worldwide i Medical Problem chronic pelvic pain/dysmenorrhea Infertility ectopic pregnancy/ miscarriage E NDO M E T R IOS I S 19 For illustrative purpo
Slide 20: Pathophysiology
PA T HO P HYSIO LOGY 20 ectopic endometrial cells proliferating endometrial cells surviving endometrial cells Adhesion Proliferation Angiogenesis immune c l ea r ance Peritoneal lining (ovary, oviduct, ligaments, bowels, etc) The figure is modified from Human Reproduction Update, Vol.17, No.6 pp. 82
Slide 21: Current Treatment for Endometriosis
Possible hormonal side - effects Med ici ne Surgery Current Treatment for Endometriosis 21 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2019 Aptorum GroupLimited Potential recurrence
Slide 22: NLS-1 efficacy in mouse endometriosis models
NLS - 1 Studies utilizing mouse endometriosis models demonstrated that administration of NLS - 1 resulted in greater reductions in the size and weight of lesions than Vitamin E, EGCG or the control without any treatment molecule . St u d ies util i z i n g m ouse en d ometrios is m o d els demonstra
Slide 23: Prophylactics & Therapeutics
Prevention Treatment S a li ne EGCG pro - ECCG Sa li ne E GCG p r o - E GCG PROPHYLACTICS & THERAPEUTICS 23 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2019 Aptorum GroupLimited Data generated by Prof. Wang, Chi Chiu
Slide 24: Efficacy in an Animal Model: NLS-1
EFFICACY IN AN ANIMAL MODEL NLS - 1 (Pro - EGCG at different doses and dosing schedule) 24 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2019 Aptorum GroupLimited Comparison of the efficacy of different treatment in an
Slide 25: NLS-1 General & Reproductive Safety
Angiogenesis 2013b NLS - 1 General & Reproductive Safety 25 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. © Copyright 2019 Aptorum GroupLimited
Slide 26: NLS-1 Preclinical Findings
NLS - 1 Preclinical Findings • Drug molecule derived from EGCG which is extracted from green tea. • Intended as non - hormonal treatment for endometriosis. • Studies in animal models show reductions in development, growth and angiogenesis of endometriosis greater than EGCG. • Our treatment may provi
Slide 27: Appendix
A pp e n d i x 27
Slide 28: Selected Income Statement Summary (US GAAP)
SELECTED INCOME STATEMENT SUMMARY (US GAAP) Ten months ended December 31, 2017 Six months ended June 30, 2018 U S $ U S $ Healthcare services income - 26,662 Costs of healthcare services - 22, 7 49 Research and development expenses 2,560,323 1,34 2 ,179 General and administrative fees 1,480,093 2,23
Slide 29: Financial Overview
FINANCIAL OVERVIEW (US$) ROUNDED TO THE NEAREST THOUSAND Cash and restricted cash, and marketable securities US$18,698,000 (as of 12/31/2017) US$25,022,000 (as of 6/30/2018) Intangible assets, net US$1,473,000 (as of 12/31/2017) US$1,452,000 (as of 6/30/2018) Operating expenses US$5,693,000 (ten mon
Slide 30: IP Status of ALS-1
IP STATUS OF ALS - 1 30 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. Exclusively licensed Title Country Application No. / Patent No. Publication No. / Grant Publication No. Application Date Expiration date Status Antiviral Compoun
Slide 31: IP Status of ALS-2 and ALS-3
IP STATUS OF ALS - 2 and ALS - 3 31 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. Exclusively licensed Title Country Application No. / Patent No. Publication No. / Grant Publication No. Application Date Expiration date Status Antim
Slide 32: IP Status of ALS-2 and ALS-3 cont'd
IP STATUS OF ALS - 2 and ALS - 3 32 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. Exclusively licensed Title Country Application No. / Patent No. Publication No. / Grant Publication No. Application Date Expiration date Status Antim
Slide 33: IP Status of ALS-4
IP STATUS OF ALS - 4 33 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. Exclusively licensed Title Country Application No. / Patent No. Publication No. / Grant Publication No. Application Date Expiration date Status Compounds And US
Slide 34: IP Status of NLS-1
IP STATUS OF NLS - 1 34 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. Technology 1 – Compound (Exclusively licensed) Title Country Application No. / Patent No. Publication No. / Grant Publication No. Application Date Expiration dat
Slide 35: IP Status of NLS-1 cont'd
IP STATUS OF NLS - 1 35 For illustrative purposes only. There is no guarantee of any project being completed or having a specific outcome. NLS - 1 c on t ’ d Technology 2 – Indication for treatment of endodermises (Exclusively licensed) Title Country Application No. / Patent No. Publication No. / Gr
Slide 36: Board of directors and advisors
PROFESSOR DOUGLAS ARNER Independent Non - Executive Director Kerry Holdings Professor in Law, HKU DR. JUSTIN WU Independent Non - Executive Director Chief Operating Officer, CUHK Medical Centre DR. MIRKO SCHERER Independent Non - Executive Director CEO of TVM Capital China MR. CHARLES BATHURST Indep