making a healthier future with...

Copyright 2019. Bioneer Corporation. All rights reserved.

Making a Healthier Future for Humanity

with Genomic Technology

Making a Healthier Future with BIONEER

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Disclaimer

CONTENTS

Chapter

01

Corporate Identity Market Products

Chapter

02

Chapter

01


Corporate Identity

Innovation•Value•Discovery l BIONEER 5

Translating Genomics Technology into Healthcare Solution!!

Healthcare Innovator

Recombinant DNA

DNA / RNA / Gene

Synthesis

Chemical Synthesis

DNA Synthesizer

/ Gene Analyzer

Instruments

Separation & Purification

of Biomaterials

Nano-Bio

Research Grade

Enzymes & Reagents

Diagnostics

Molecular Diagnostics

Therapeutics

RNAi-Based New Drug

Development

Prevention

Probiotics & Microbiome

01 Key Technology Road Map

Corporate Identity


Synergy in Business

• The key technology of each division is organically integrated.

• Create and maximize synergy by Bioneer strategy.

Location Daejeon, South Korea

KOSDAQ Listed

/Established 1992.08/2005.12

Key Products

MDx Instruments and Kits,

Oligos and Research Products,

siRNA Drug Development

Employees 380 (as of 2019.04)

Webpage www.bioneer.com

Han-Oh Park, President & CEO

• B.S. Chemistry, Seoul National

University (84’)

• Ph.D. Biochemistry, KAIST (92’)

• Vice President, Korea Biotechnology

Industry Organization

• Adjunct Professor, KAIST

• Committee Member,

Presidential Advisory Council on

Science & Technology

02 Company Overview

Corporate Identity

Genomic Healthcare Company

DNA/RNA oligonucleotide

Synthesis Technology

SAMiRNA (RNAi

therapeutics)

BNR17 Probiotics & Microbiome

Gene Analysis Kits &

Instrument

Molecular Diagnostics Kits & Instrument


Bioneer continues to challenge itself to become a global healthcare company.

1992

• Est. Korea Biotech Inc. (1st KRIBB spin-off)

• First in Korea to develop and supply enzymes and primers for PCR

1996

• Renamed BIONEER Corporation

2001

• Completion of Daejeon DNA synthesis center

2002

• Development and deployment of Bio-terror agent detection real-time PCR instrument

(first in Asia)

2014

• Certification, Functional Indredient for KFDA of Lb.gasseri BNR17

2012

• Certification, Innovative Pharmaceutical Company (2012-2018)

2009

• Certification of Korean GMP for Korean IVDD manufacturing and quality management standard conformity

2005

• IPO (KOSDAQ)

2015

• Licensing-Out 3 drug candidates to Yuhan Corp.

• Selected as the K-BrainPower

2016

• 1st multiplex kit on Zika WHO EUAL

2018

• CE-IVD List A approval for HIV-1 Quantitative RT-PCR kit (First in Asia)

Corporate Identity

03 Company History


Corporate Identity

04 Business Portfolio

DNA/RNA

Synthesis

AccuPower®

PCR technology DNA Synthesizer/

Gene Analyzer

BIONEER COMPETITOR

Life Science Research

Sustained and stabilized revenue growth 2018, CE-IVD List A approval for HIV-1 Quantitative

RT-PCR kit (First in Asia) 2019, CE-IVD List A approval is expected (HBV, HCV MDx kits).

Molecular Diagnostics

MDx Kits MDx Instrument

(qPCR/Prep) Package closed system

• Isolation of Lb. gasseri BNR17 from human breast milk (2006.08)

• Approved as functional ingredients with body fat reduction for functional foods by KFDA

• Establish subsidiary: AceBiome Inc. (2017.04)

• Global licensing agreement and supply contract

Lb. gasseri BNR17

2018, Preclinical tox study for IPF and keloid

• Two-track approach for new drug and healthcare products development

• Strong intellectual property position of siRNA and SAMiRNA

• Powerful siRNA delivery platform technology for various diseases

• Joint research partnership with Yuhan Corp. and global pharmaceutical companies

RNAi New Drug(SAMiRNA™)

2018, Global licensing agreement

• Life Science Research

• Molecular Diagnostics

• Lb. gasseri BNR17

• RNAi New Drug(SAMiRNA™)


Chapter

02 Market Products


Sustained and stabilized revenue growth

Market Products

01-1 Life Science Research

ExiProgen™: Nucleic Acid Extraction & Protein Synthesis System

• The world’s first instrument for protein expression and purification, as well as nucleic acid extraction.

• Express and purify up to 16 proteins simultaneously for mutant screening, functional analysis, vaccine R&D, assay development and antibody development.

• Key Customers: Genentech, Stanford University, NPL, etc.

AccuPower ® PCR technology

• Lyophilized room-temp-stable PCR premix, longer shelf life – more than one year.

• Pyro-HotStart™ PCR: Enzyme -based HotStart PCR for the specific DNA amplification

• Dual-HotStart™ RT/PCR : One-tube RT/PCR for more specific & sensitive RNA amplification

MagListo™ Nucleic acid extraction

• Next Generation nucleic acid purification kits with magnetic silica Nanoparticle

BIONEER Competitor


Sustained and stabilized revenue growth

Market Products

01-2 Life Science Research

DNA/RNA Synthesis

• Ensure High-quality & capacity Competitiveness with unique vertically-integrated DNA/RNA production

• The first developer of 384 parallel oligonucleotide synthesizer

• Raw material synthesis facility: Ton-scale phosphoramite capacity, >100 kinds of raw materials production

• Fully automated proprietary synthesis systems can produce over 30,000 oligonucleotides per day

• The state-of-art QC system: MALDI-TOF(7 systems), Capillary Electrophoresis system, LC-MASS

Gene Synthesis

• Fully automated and integrated Gene Synthesis technology

• With our oligo and molecular biology reagents, Bioneer offers the gene2protein™ service: codon optimization, gene synthesis, cloning and sequencing and protein synthesis.

Manufacturing Infrastructure



MDx Instruments

• First developer in Asia

• Patented Light-Tunnel-technology for more sensitive and uniform quantification

• Certified CE-IVD, sFDA(China), FSZ(Russia)

• Viral pathogens: Hepatitis B, C, HIV, Influenza, FMDV, CMV

• Tuberculosis, respiratory diseases, STIs

• GMO screening • Veterinary disease screening including bird flu,

foot-and-mouth disease etc.

• Food poisoning, water screening for Norovirus, enterovirus etc.

Real-time qPCR (Exicycler™ 96)

• Patented three protection devices against aerosol contamination enable high sensitive detection without noise signal.

• AccuNanobead™ silica magnetic nanoparticles enables pure and high yield extraction of nucleic acid

• Compact and economical design

Gene Extraction (ExiPrep™ 16 Dx)

MDx Kits

• Ultra sensitive molecular diagnostics technology from Pyro-HotStart™ and Dual-HotStart™

• Outstanding stability through patented lyophilized PreMix

• Superior sensitivity, specificity and convenience

• Detection of various pathogens and genetic mutations

• CE-IVD certified

Diagnosis

Plant /Animal

Screening

Food Screening

Market Products

02-1 Molecular Diagnostics

Competitive Edge • Bioneer has developed and commercialized total solution of MDx including instruments and kits.

• Secured cost advantage through the in-house production of expensive raw-materials

• MDx Key technologies invention such as Dual-HotStart™, the most sensitive RNA detection technology

MDx Kits (AccuPower® PreMix Technology)



* Only apply to ExiStation™ 48A

• Automated MDx system consists of ExiPrep™ 16 Dx and Exicycler™ 96

• Completion of diagnosis from sample preparation to Real-Time PCR in only 3.5 hrs

• Simultaneous diagnosis allows earlier detection of superinfection, such as HIV and TB.

• Optimized for ExiPrep™ Dx Extraction Kits and AccuPower® MDx Kits

• Consists of ExiPrep™ 48 Dx, Exicycler™ 96 and/or ExiLT*

• Advantageous when using same type of specimen.

• Nucleic acid extraction from 48 samples within an hour.

• Use primary tube directly : decapping/capping of sample tube and sample transfer motions are all automated.*

• Sample information is inputted automatically using built-in barcoding system*

Market Products

ExiStation™

02-2 Molecular Diagnostics System

ExiStation™48/48A System


Sexually Transmitted Disease

Hepatitis & HIV • HBV Kit

• HCV Kit

• HIV-1 Kit

Transplantation -related Disease

• CMV Kit

• EBV Kit

• BKV Kit

Gastro-intestinal Disease

• Norovirus Kit

• Enterovirus Kit

Mosquito-borne Disease

• ZIKV multiplex Kit

(ZIKV, DENV, CHIKV) Respiratory Disease

• InfA Kit

• New InfA Kit

• CP Kit

• MP Kit

• MERS-CoV Kit

Human Papillomavirus

• HPV 16 & 18 Kit

• HPV Genotyping Kit

Tuberculosis • MTB Kit

• MTB & NTM Kit

• TB & MDR Kit

• TB & XDR Kit

• MTHFR Kit

• JAK2 V617F Kit Genotyping • ApoE Kit

• Warfarin Kit

• HLA-B27 Kit

• TPMT Kit

• Factor V Leiden Kit

Market Products

02-3 Applications

• STI 8A Kit (CT, NG, UU, MG)

• STI 8B Kit

(TV, MH, HSV1, HSV2)

• STI 4C Kit (TP, UP, CA, GV)


Market Products

02-4 History of BIONEER’s MDx Product

* This history is based on the year of achievement of CE mark.

•Exicycler ™ 96

(2008)

~2008 2009 2010 2011 2013 2014 2015 2016 2018

•14 types of Real-Time PCR Kit

(including MTB&NTM, EBV,

InfA and etc.)

•BKV Quantitative PCR Kit

•MTB Real-Time PCR Kit

•6 types of ExiPrep™ Dx Kit

•TB & MDR Real-Time PCR Kit

•TV Real-Time PCR Kit

•UU Real-Time PCR Kit

•Exicycler ™ 96 V4


•ExiStation ™ V4

•ExiStation ™ 48 / 48A

•ExiPrep ™ 48 Dx

•ExiPrep ™ 48 Viral DNA/RNA Kit

•ExiPrep ™ 48 Viral RNA Kit

•TB & XDR Real-Time PCR Kit

•CE-IVD List A approval for HIV-1

Quantitative RT-PCR kit (First in Asia)

•ExiStation ™

•ExiPrep ™ 16 Dx


(including HPV 16 & 18 kit, STI

multiplex kit and etc.)

•STI8A-Plex Real-Time PCR Kit

•CT&NG Real-Time PCR Kit

•Listing of HIV(CE) on the

Global Fund

•ExiPrep ™ 96 Lite

•(Plan)CE-IVD List A

approval for HBV, HCV

Viral Load Test Kit

2003

SARS Diagnostic

Solution :

ABADIS

Mobile PCR Lab

in China 2009

Swine Flu (H1N1)

Diagnostic Kit :

about 2 million

cases were

tested 2014

Ebola Virus

Diagnostic Kit :

development

with Nigeria

Government 2016

Zika Multiplex

Diagnostic Kit

: 1st multiplex kit

on WHO EUAL

2019~

HIV-1 viral load

test kit : CE-IVD,

List A approval

& listing on “the

Global Fund” 2019

AIDS


Functional recognition and commercialization

Screening of probiotic lactic acid bacteria from various sources and selection of Lb. gasseri BNR17 from human breast milk (August 2006)

2nd clinical trial to study anti-obesity activity supported by Korean government fund in progress

3rd clinical trial to study bowel function improvement in Irritable Bowel Syndrome and anti-diabetic activity supported by Korean government fund in progress

Approved as functional ingredients for Functional Foods by KFDA

Global licensing agreement and supply contract

Discovery of Lactobacillus strain for body weight control

• Project initiated on anti-obesity microorganisms

• Isolation of 1st anti-obesity microorganisms

1999 2003 2008 2013 2016

2000 2006 2012 2014 2018

• 1st patent application for anti-obesity microorganisms

• 2nd clinical trial: anti-obesity

• 3rd clinical trial: IBS

• KR patent registration for anti-obesity microorganisms

• Patent 10-1108428

• Isolation/characterization of Lb. gasseri BNR17 from human breast milk

• US Patent application for BNR17

• 1st clinical trial: anti-obesity

• US Patent registration for Lb. gasseri BNR17

• Approved as functional ingredients by KFDA

• Product launch

• Licensing-out

• Awarded Weight Management Ingredient of the Year, NutraIngredients-USA Awards 2018

Market Products

03 Anti-obesity probiotic, isolated from human breast milk



Central Dogma

DNA

RNA

PROTEIN

Blocking “production” of disease-causing proteins

siRNA (small interfering RNA)

Blocking “function” of disease-causing proteins

Antibody, conventional

chemical drugs

121 103 106

125 142

172

213 231

201

235 245 248

264 274

355

Source : Gary Carter, The Oligo Therapeutics Market Landscape, TIDES 2016 presentation

Number of total therapeutic oligo programs has almost tripled since early 2000.

Oligo Therapeutics Programs

New drug modalities are mainly based on sequence.

Market Products

04-1 RNAi New Drug


• SAMiRNA™(Self-Assembled-Micelle-inhibitory-RNA) is a novel class of RNAi molecule developed by Bioneer, which provides the solution for virtually all major difficulties in the development of RNAi-based therapeutics including siRNA delivery.

• Using this novel RNAi prodrug technology, Bioneer is currently advancing clinical development of pipeline programs for previously non-druggable diseases through our own pipeline efforts as well as through partnerships with major global pharmaceutical companies.

SAMiRNA™ solves the unmet needs in RNAi drug development.

SAMiRNA Description Summary

• The world’s first siRNA prodrug technology: highly stable in circulation and siRNA is released and active only within the target cells

• in vivo efficacy validated in animal disease models via low dose I.V. injection

• Superb serum stability (PK/PD validated)

• Powerful siRNA delivery platform technology: Flexibility to incorporate siRNA sequences against any disease target

• Strong intellectual property position around SAMiRNA’s unique structure and manufacturing processes

• Extremely low toxicity and cytokine induction

• Fully automated solid phase chemical synthesis of siRNA conjugates; advantage of manufacturing & QC processes for large scale production of siRNA drug

Market Products

04-2 Competitive Edges

RNAi (drug)

Structure of SAMiRNA™


Bioneer has vertically integrated siRNA drug development processes

from high throughput siRNA synthesis to screening of SAMiRNA™.

• Large scale RNA

synthesis

• In-house developed

automated

synthesizer

• In-house developed

raw material

• Next generation

siRNA nanoparticle

SAMiRNA™

• Target gene

knock-down

quantification by

MIQE qPCR

analysis

• in vitro siRNA

delivery/efficacy

validation

• in vivo efficacy

validation

• Patented

siRNA design

algorithm

Market Products

RNAi Core

Technologies

Design

Efficacy

Validation

siRNA

Delivery

Synthesis

Drug Development Roadmap

04-3 RNAi New Drug


in vitro screening and validation of siRNAs

Design and Synthesize siRNAs

MIQE qPCR analysis Deep sequencing

Preclinical in vivo test using SAMiRNA

in mouse tumor model

Large scale manufacturing

Non human primate test, toxicity screen

IND filing


Market Products

04-4 SAMiRNA™ Programs and Pipeline

Discovery Preclinical Clinical Trials

Phase Ⅰ Phase Ⅱ Phase Ⅲ

Consumer Testing (2019.2Q) Healthcare Programs

Androgen receptor

Preclinical Study (2018. 03)

Preclinical Planned (2019.4Q)

Bioneer Programs

IPF

CKD

Diabetes

Lung cancer

Autoimmune

NASH

Keloid

L/O to Yuhan Corp.

Keloids

Solid cancer 1

Psoriasis

Preclinical Planned (2019.2Q)


Major fields of development

• New Drug : Fibrosis drug for lung, Skin, Kidney, Liver, Lung cancer, Autoimmune disease, Diabetes

• Healthcare : Hair loss prevention product

www.bioneer.com

Address | 8-11, Munpyeongseo-ro, Daedeok-gu, Daejeon 34302, Republic of Korea

Tel | +82.42.930.8513

Fax | +82.42.930.8600

E-mail | [email protected]

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