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BioCure Technology Inc. CSE: CURE OTCQB: BICTF Investors Presentation April 2019 BiocureTechnology

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Page 1: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

BioCureTechnology Inc.CSE: CURE OTCQB: BICTF

Investors PresentationApril 2019

BiocureTechnology

Page 2: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

BiocureTechnology

Disclaimer

Forward-Looking Information

Not for Distribution; No Offering

This presentation and the material contained herein are confidential and are not to be disclosed to the public. This presentation is for information purposes only and may not be reproduced or distributed to any other person or published, in whole or part, for any purpose whatsoever. This presentation does not constitute a general advertisement or general solicitation or an offer to sell or a solicitation to buy any securities in any jurisdiction. Such an offer can only be made by prospectus or other authorized offering document. This presentation and materials or fact of their distribution or communication shall not form the basis of, or be relied on in connection with any contract, commitment or investment decision whatsoever in relation thereto. No securities commission or similar authority in Canada or any other jurisdiction has in any way passed upon the adequacy or accuracy of the information contained in this presentation.

Forward-Looking Information

Certain disclosure in this presentation, including statements regarding the potential market for BioCure’s products constitute forward-looking statements. In making the forward-looking statements in this release, BioCure has applied certain factors and assumptions that are based on BioCure’scurrent beliefs as well as assumptions made by and information currently available to BioCure, including the assumption that the market for BioCure’sproduct will continue to increase as anticipated. Although BioCure considers these assumptions to be reasonable based on information currently available to it, they may prove to be incorrect, and the forward-looking statements in this presentation are subject to numerous risks, uncertainties and other factors that may cause future results to differ materially from those expressed or implied in such forward-looking statements. Such risk factors may include, among others, the risk that the market for BioCure product will not increase or continue as anticipated.

Readers are cautioned not to place undue reliance on forward-looking statements. BioCure does not intend, and expressly disclaims any intention or obligation to, update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

Page 3: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

BiocureTechnology

Executive Summary

• BioCure specializes in the development of BioSimilar

pharmaceutical products

• A social agenda vision; To provide affordable key pharmaceuticals

• A multi-billion dollar market of unmet medical needs

• Unique knowhow and research capabilities

• Advanced stages of trials with planned commercialization in 2020

• Experienced management and scientific staff

• Headquartered in South Korea(2005) and trading on the Canadian Stock Exchange

• Planning dual listing on NASDAQ in 2019

Page 4: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

Classification Key Content

Aug. 2005 Company founded (Paid-in capital of USD 50,000)

Jan. 2012 Established Biocurepharm-MG in Singapore, co-founded by Macauley Gehler(BPK holds 50% stake)

Aug. 2012 Attracted USD 500,000 foreign investment by Macauley Gehler Singapore

Jul. 2016 Contracted IPO in Canada stock market with Columbia Capital Inc.

Oct. 2016 Established Biopharma-Swiss in Switzerland, co-founded by Sibitec (the largest shareholder 34%)

Oct. 2016 Development of Hair Growth product containing stem cells, three recombinant human growth factors

Oct. 2016 Contracted joint venture for FMD Vaccine production with Pharos Vaccine, Korea

Sep. 2017 Launched RCHG (Recure Cell Hair Growpac)

Nov.2017 Listed in the Canada Stock Exchange (CSE)

Dec.2017 Announced clinical trial of CAR-T as the nation’s first

Jan.2018 Launched RCAW (Anti-Wrinkle) and RCPW (Pure Whitening)

Jun.2018 OTC listing obtained in the US

Oct.2018 Completed pre-clinical trial of CAR-T as the nation’s first in Korea

Company Milestones

Page 5: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

▪ RCHG, RCAW, RCPW launched

➢ Development of human growth

factors as cosmetic ingredient ➢ Foot and Mouth Disease Vaccine

➢ Using recombinant protein as

opposed to cell culture

▪ CAR-T Cell therapy preclinical completed in 2018

▪ Clinical trial Scheduled for late-2019

➢ Ongoing - to commercialize the

first CAR-T cell therapy in Korea

Main Business Category

▪ Interferon-ß preclinical in progress to be

completed in 2019.

➢ Biosimilar and biopharmaceuticals

development

➢ Join Venture Project (in the field of

technology support)

➢ BiocurePharm’s therapy is based on genetic recombinant protein technology, and developed with collaborators in

various fields

Page 6: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

The Plan

• BioCure can reach commercialization of its products by 2020

• Estimating to reach over USD 100m revenues with circa USD 80m EBITA by 2022

• We plan to release new products each year

• Expansion via M&A of smaller companies and additional IP for BioSimilars

• 8 commercial BioSimilars product portfolio by 2025

Page 7: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

d 2018 20192018Classification Project 2018 2019 2020 2021

Biopharmaceu

ticals

CAR-T therapy

Interferon-β

Ranibizumab

PEG-Filgrastim

Classification Product 2017 2018 2019 2020

Overseas network

FMD

Clinical Launching

Clinical LaunchingPre-clinical

ClinicalPre-clinical

ClinicalPre-clinical

Approval

1 contract1 contract

1 contract 1 contract

Pre-clinical

Company Roadmap

Page 8: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

H1 2019 USD 5m round

$3m CAR-T Clinical Trials in Korea

$1m Working capital

$1m Completion of pre-clinical trial for Interferon Beta in Korea

H2 2019 USD 10m round

$7m Completion of Clinical Trials for CAR-T in Korea / Start

Clinical Trials for CAR-T in Germany

$1m NASDAQ listing preparation

$1m Start Clinical Trail for Interferon Beta in Brazil / Turkey

$1m Working capital

Latest Capital Raise

C$1,103,749 by issuing 96,404 new shares of Korean Subsidiary

on Feb. 28, 2019 through a private placement to Bio- Healthcare

Association, a leading group in Biotech industry in Korea

Financing Roadmap

Page 9: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

BiocurePharm Corp. (Korean Subsidiary)

• Outstanding Shares 3,688,236

• CURE ownership 3,591,832 (97.4%)

• Outstanding Options / Warrants Nil

BiocureTechnology

Cap Table

Biocure Technology Inc. (CSE: CURE)

• Outstanding Shares 96,793,301

• Outstanding Options 4,500,000

• Outstanding warrants 1,895,340

• Insiders’ holdings 30%

Page 10: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

(Unit : USD)

Classification Project Period Funding Party Amount

AntibioticsThe shortest commercialization of Anti-TNF-Alpha

McAb(Infliximab), an Antibiotics. 2007.5~2008.4

Ministry of Knowledge

Economy700,000

Biopharmaceuticals

(Anti-Cancer)

Research for optimal indication and non clinical trial to

commercialize new solid cancer treatment,

ATIMPISTATIN(HAS-TIMP-2)

2007.7~2010.7Ministry of Knowledge

Economy2,500,000

Biopharmaceuticals

(Anti-Cancer)

Verification for increased efficacy of anti-cancer that inhibits

angiogenesis by PET/CT/SPECT for animals2007.7~2009.6

Small and Medium

Business

Administration

1,000,000

Diagnostics(Cancer)Diagnostic commercialization and Development for monitoring

by specific antigen for colorectal cancer2007.7~2010.6

Ministry of Health and

Welfare770,000

Stem cell treatmentNon clinical trial of developing treatment for hair loss using

adipose derived stem cell media.2013.3~2014.9

Ministry of Health and

Welfare106,000

Biosimilar

Production of API for non clinical trial sample preparation of

multiple sclerosis treatment. Development of formulation for

interferon beta1b, MS treatment

2018.8~2018.9

2018.10~2018.12Daejeon Tech Park 180,000

Others

(Recombinant protein

for material)

Development of manufacturing process for Vesicular

Endothelial Growth Factor in Saccharomyces cerevisiae2018.12~2019.02 Daejeon Tech Park 100,000

Total 5,816.000

Government Funded Research

Page 11: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

▪ BiocurePharm’s CAR-T Cell therapy is 2nd generation using CD-19

▪ BiocurePharm established standard protocols for the conditions of CAR-T Cell therapy, re-injection,

management of side-effects, and combined therapy with other programs

▪ BiocurePharm will have the 1st CAR-T therapy clinical trial in Korea

▪ Pre-clinical trial completed in 2018

▪ Clinical trial is scheduled for late-2019

CAR-T cell immunotherapy

- Chimeric Antigen Receptor modified T cell therapy

- The most competitive and advanced treatment for

Acute lymphoblastic leukemia (ALL)

Fig. copyright@2015 Norvatis

CAR-T Cell therapy in BiocurePharm

Page 12: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

Comparision of developing for anti-cancer drug

developement1st (chemical-) 2nd (Specific-) 3rd(Immuno-)

▪ Anti cancer drug with cellular toxins to

induce cell death

▪ Attacking cancer cell with specific

reaction

▪ Reactivation for immunity

▪ Improvement for immune system

▪ Very high toxicity (secondary cancers)

▪ Not effective in all patients

▪ Also normal cell are killed

▪ Lower side effect than 1st generation

▪ Variable efficiency

▪ Resistance will develop

▪ High efficiency

▪ Complete recovery

▪ Natural treatment by memorial immune

system

- Emily Whitehead

1ST patient to participate clinical trial for CAR-T

Cell immunotherapy

She is 18 years old and recovered completely.

She is living cancer free more than 5 years

after treatment

- Chimeric Antigen Receptor modified T cell therapy

Immuno-cell therapy : CAR-T Cell therapy

Page 13: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

▪ CAR-T Cell for Acute lymphoblastic leukemia (ALL)

▪ Competitive treatment individually customized for the blood cancer

▪ Novartis has shown 83% complete response for the patients who are terminally ill

[Mechanism]

▪ The treatment: Extracts T-Cells from the patient’s blood and modify the cells with a specific virus

▪ Then grows the modified cells and inject back in the patient. Now cells kill the cancer

Immuno-cell therapy : CAR-T Cell therapy

Page 14: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

Coherent Market Insights, CAR-T Cell therapy market (2017.2)

Global Market size and prediction of CAR-T cell therapy (2017-2028, million dollars)

Market size (million$)

Growth rate year on year (%)

▪ The 1st CAR-T Cell therapy Kymriah was launched in late 2017(USA) and 2018(EU) by Novartis

▪ The therapy is expected to benefit many leukemia patients – old and young

▪ According to a 2015 NIH report there are more than 340,000 patients in the U.S. suffering from leukemia

▪ The global CAR-T cell therapy market is growing at an explosive rate

▪ Annual growth rate is expected to average around 53.9% (2017-2028)

▪ The market value for CAR-T cell therapies is anticipated to be significant

- Chimeric Antigen Receptor modified T cell therapy

Immuno-cell therapy : CAR-T Cell therapy

Page 15: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

- Chimeric Antigen Receptor modified T cell therapy

Documents to apply for clinical trial

✓ Nonclinical toxicity and distribution completed

✓ Establishment of the specification and assay completed

✓ Manufacturing in GMP is in process

✓ CMC(Chemistry, Manufacturing and Control) completed

Choose the clinical center

Submit plan for trial

Application for IND Status

CAR-T Cell therapy in BiocurePharm

Page 16: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

CAR-T Cell Immunotherapy

Coherent Market Insights, CAR-T Cell therapy market (2017.2)

CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars)

▪ Comparing the CAR-T Cell therapeutics market by target antigen, the market for CD19 antigen steadily maintains the

largest share of the market

▪ Studies on CAR-T Cell therapeutics using CD19 as a target antigen are actively under way.

Page 17: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

Process of manufacturing for BCP019_ Lentiviral vectors- Chimeric Antigen Receptor modified T cell therapy

(Replication Competent Lentivirus Assay)

Page 18: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

- Chimeric Antigen Receptor modified T cell therapy

▪ PBMC (Peripheral Blood Mononuclear Cell)

Process of manufacturing for the Drug Product, BCP019

Re-injection into body to attack and kill a cancerous

cells after making CAR-T cell using T cell extracted

from patient’s blood

Page 19: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

Development and Efficacy Test - Chimeric Antigen Receptor modified T cell therapy

➢ Confirmation of BCP019 CAR-T

therapy for leukemia on animal

model test

Construction of Letiviral vector system Genetic transduction into T cell Efficacy test (Preclinical)

Page 20: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

BCP019_ Safety Test- Chimeric Antigen Receptor modified T cell therapy

Efficacy DistributionSingle to

toxicity

Repeat to

toxicity

Genetic

toxicity

Carcinogen

eticity

Reproducti

on toxicityOthers

O O O X X △ X △(Local)

Toxicity test

Single to toxicity

- Single administration

- Test Model: Nude mice

(6 males and females per a test)

- How to inject: intravenous

- Dosing: Low, middle, High

→ maximum dose considering safety

- Period: 28 days

Results :

There is not any specific toxicity to test, when the BCP401 inj

ects individually single administration into immunodeficienicy

animal Balb/c nu/nu mouse. The NOAEL is maximum dose,

5x10^7 cells/head.

Distribution

- Single administration

- - Test Model: Nude mice

(5 males and females per a test)

- How to inject: intravenous

- Dosing : maximum dose considering safety

- Test organs: Inguinal LNs, Lung, Heart, Kidney, BM, Liver, Gut,

Skin, Blood, Spleen, Gonads, Brain

- Detection for BD: qPCR by validated protocol

Results :

The test results indicate that the foreign substance, BCP40

1 will be completely eliminated on 7th and 28th days after ad

ministrating it to the immunodeficiency animal Balb/c nu/nu

mouse. That means there will be little toxic effects that rem

ain to affect other organs

Page 21: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

Currently stage of BCP019: Production of sample for Clinical trial

- Chimeric Antigen Receptor modified T cell therapy

BCP019 IND filing

➢ Preclinical efficacy / toxicity test completed

➢ SOP and Specification for manufacturing on GMP facility

➢ CMC (Chemistry, Manufacturing and Control)

Development of Clinical

protocol

→ IND apply

Current stage

Page 22: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

- Chimeric Antigen Receptor modified T cell therapy

➢Clinical hospital or institute

➢ Korea : Seoul National University Hospital, Asan Medical Center

➢Germany : Berlin Charite Univ. (Brandenburg Center for Regenerative

Therapies) Initial agreement

➢ Expected date for Korean IND submission

➢ AUG 2019

➢ Expected date for clinical trial

➢ Korea : 3Q 2019 (Targeted by Jul. 31, 2019)

➢Germany : 4Q 2019 (Documentation of IND in Korea will be submitted to

EMEA)

Plan for Clinical trial of BCP019

Page 23: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

- Chimeric Antigen Receptor modified T cell therapy

Plan for production, GMP facility and advance for global market

Area Plan Progress

KoreaIt will be established in a Science business belt in Daejeon city on a site

already owned by Biocure Pharm

Design in 2019,

Completed in 2021

Germany Using the existing GMP facility in the Charite institute, Berlin In progress with local

partner in Germany

Canada Using the GMP facility for producing cell therapy in Toronto, CCVP (The

Centre For Cell and Vector Production) and BCCA, Victoria, BC

It is scheduled to discuss in

2019

Sweden Initiating talks with Karolinska Hospital and Sahlgrenska

Asia Negotiating with Wellness Hospital to establish a facility in Malaysia first In Negotiation

Others Italy, Austria, Swiss, Poland, Russia etc

▪ If existing facilities and production systems are available, it will be advantageous for the business to proceed.

Page 24: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

- Chimeric Antigen Receptor modified T cell therapy

Further R&D planning on basis of the CAR-T therapy

➢ Targetable to Solid tumor

: Pancreatic cancer, Lung cancer, Ovarian cancer

① Development of new treatment for solid cancers using antibody technology of Y biologics that have various libraries

of antibody and developing techniques

② Development of treatment for solid cancers using combination injection with IL-2 and IL-7

➢ Joint research with our networks in Canada, Germany, U.S

▪ Germany : Probiogen

▪ Canada : UBC and/or UVIC (University of British Columbia or University of Victoria)

The possibility of solid cancer target treatments using CAR-T cell is seen as likely and important

No CAR-T cell treatment for solid tumor has been approved by the FDA yet

Several early clinical studies have indicated inroads to successful treatment in solid cancers

Page 25: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

Reporter Jong Won Chang at Biospecdata on January 8, 2019

Y Biologics - Biocurepharm‘ ICI+CAR-T Combined Therapy’ Development of Anticancer Treatment for Solid Tumors

Anti PD-1 Mono Clone Antibody YBL-006 & Anti-CD-19 CAR-T Combined Therapy

Development

The purpose of this agreement is to research the effectiveness of combined treatment of Immune Checkpoint Inhibitor

PD-1 (Programmed Cell Death Protein-1)developed by YB and anti-CD19 CAR T-Cell Therapy developed by BPK.

Next Generation Anticancer Treatment for Solid Tumors.

Page 26: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

Patent issue for CD19_CAR-T cell therapy

◼ Comparison of BCP019 and Kymriah(CTL019)

BCP019 Kymriah

Company BiocurePharm Novartis

Molecular target ◼ CD191) : Same

Structure◼ 2nd generation CAR

anti-CD19 binding domain / intermembrane domain / co-stimulating domain

Stimulating site

CD3ζ(zeta)Amino acid Sequence of St. Jude Some amino acid altered

Anti-CD19 binding domain Mouse antibody(FMC63 scFv)2) Humanized antibody3)

1) CD19 is a cell surface component of the B cell receptor complex involved in B cell activation

2) The sequence of FMC63 scFv is already opened in 1997. : Construction and characterization of a functional CD19

specific single chain Fv fragment for immunotherapy of B lineage leukemia and lymphoma. (Nicholson et al. Mol. Immun.

34(16-17) : 1157-1165(1997))

3) Novartis patent is “WO2014153270A1, Treatment of cancer using humanized ant-cd19 chimeric antigen receptor”

4) The original patent of St. Jude will be expire 2023, and that is only entitled to the U.S.

Page 27: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

M&A and contracts of CAR-T cell related companies

Company Product Relation information Comment

Celgene

JCAR015

JCAR017

JCAR019

Juno therapeutics was acquired for $9 billion in Jan.

2018

Juno therapeutics was not approved because

patient died in the clinical trial for JCAR015 of

Juno therapeutics

NovartisKymriah

($475,000)

Pennsylvania university had co-studied with Novartis

and Kymriah was launched in 2017First approved CAR-T

GileadYestcarta

($373,000)

Kite Pharm was acquired for $12 billion in Oct.

2017

Cell design labs was acquired for $ 0.5 billion in 2018

Cell design lab has on/off switchable technique

Kite Pharm KTE-C19

Contract of development and Sales right with

Daichisankyo in Japan

Established Joint Venture with Pusing pharm in China

Contract of partnership of Amgen, Genenetech, GE,

NIH, Biotech etc.

Kite pharma established the facility that can

supply up to 5,000 patients per year around LA

airport

Page 28: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

Competitive Advantage

• BioCure is well positioned to gain leadership with advanced CAR-T solutions

• BioCure is an early Biosimilars entrant with strong knowhow and products already in development

• Biosimilars market development is in its early stages

• Competition is limited in comparison to Generic drugs

• Biosimilars have high barriers to entry as they require unique knowhow – e.g. – there are only three known competitors for BioCure MS product (Interferon Beta)

BiocureTechnology

Page 29: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

The incidence of Lymphoid Leukemia in Korea

Source –Current state of hematologic malignancy and hematodyscrasia and

an analysis of blood transfusion amounts

- Age-specific lymphoid leukemia patients

-Current state of age-specific lymphoid leukemia with newly

diagnosed cases

▪ Total number of Lymphoid Leukemia patients has been increased by 5.7 percent annually and in 2015, newly

diagnosed cases were 1,008.

▪ It is a rare disease in incidence criteria but has a high incidence rate to infants.

▪ In 2016, cumulative number of patients was 5,745 but patients under 19 were 2,654 which accounted for 46

percent.

▪ That was 0.005 percent of Korea’s population.

Page 30: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

The incidence of Lymphoid Leukemia per country

Source – Cancer causes control

- Age-specific ALL incidence(2003-2007) : people/for every 100,000 people

▪ According to WHO(2003-2007), age-specific ALL incidence varies by

region and Western Europe , America, and Oceania are having a

higher incidence rate than Eastern Europe and Asia – both incidence

rate and the number of patients have been increasing.

▪ WHO(2003-2007): age-specific ALL incidence is related with

diagnostic technique and socio-economic backgrounds.

▪ Lymphoid leukemia occurs more frequently in people under the age

of 19. - ALL Onset prediction(2015) : Number of patients(people)

Page 31: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

CAR-T Cell Immunotherapy - Marketing Plan

▪ (Korea) Total number of Acute Leukemia patients(ALL) is about 5,000 (including 2,600 of

Infants) and approximately 1,000 new cases are reported every year, with 5.7 percent

annual growth rate.

▪ (International) A number of acute Leukemia patients varies by country but roughly 50 –

3,000 new cases are reported every year. The number of patients has been increasing

and the market size is also expected to increase.

▪ Clinical trials are conducted in Korea, Europe, Canada, Asia, South America, and North

America as well as the product launch. The below tale shows our target number of

patients in the market.

Area Launching Year Number of Patients

Korea 2020-2021 100

Europe, Canada 2021-2022 300-600

Asia, South America 2021-2022 300-400

USA 2024- 500

Page 32: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

• “…BioSimilars will provide access to important therapies for patients who need them…”FDA Commissioner Margaret A. Hamburg M.D.

BiocureTechnology

Biosimilar and Biopharmaceuticals by

Biocurepharm

➢Multiple Sclerosis Treatment : Interferon β

➢Combine therapy for Anti cancer and blood disease : PEG-GCSF

➢Macular Degeneration Treatment : Ranibizumab

Page 33: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

Current Market Conditions

▪ Multiple Sclerosis Market size in 2017 was approximately USD

21.5 billion

▪ One of the blockbuster bio-similar candidates

▪ Main players are 3 companies in the world

▪ There are many patients in the Middle East, North Africa,

Eastern Europe, and Brazil that do not have the same access

as patients in the major countries

▪ Completed preparation for mass production

▪ Progressing to preclinical trial

Status of Current Development

▪ Middle Eastern, North African and Brazilian markets first

▪ Main production will be with the joint venture companies in

Turkey and Iran

▪ Current market average sales price is about USD 350/vial

▪ Manufacturing cost is extremely low compared to selling price

Market entry strategy

▪ It will take 24 months to complete the pre-clinical and

clinical trial processes

Entry barrier

Biopharmaceuticals : Interferon-β

Page 34: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

Current Market Conditions

▪ Filgrastim is an anti-cancer treatment that plays an important

role for the recovery of cancer patients’ immune system

▪ Amgen created a market of more than USD 6 billion by selling

the first general drug called Neupogen (Filgrastim)

▪ Sales of second generation Neublasta (PEG-GCSF) are

increasing in the total market for GCSF (ONE injection vs. daily)

▪ Several companies produce the first generation Filgrastim

▪ Plan to produce the second generation product the patent for

which expired in 2016 by bio-similar

▪ Already secured production technology of the first generation

of Filgrastim

Status of Current Development

▪ BiocurePharm will launch this product in Middle East, Eastern

Europe, Turkey, Indonesia, Thailand and Malaysia through

overseas partners as the first stage

▪ The product will be price-competitive with highest quality

Market entry strategy

▪ It will take 28 months to complete pre-clinical and clinical

trial processes

Entry Barrier

Biopharmaceuticals : PEG-Filgrastim(G-CSF)

Page 35: BioCure Technology Inc.€¦ · CAR-T Cell therapeutics by target antigen market statue and forecast (2017-2028, million dollars) Comparing the CAR-T Cell therapeutics market by target

Current Market Conditions

▪ Novartis entered the market with “Lucentis”

▪ Annual market size is more than 9 billion as of 2017

▪ Potential demand is increasing rapidly and currently many

pharmaceutical companies want self production

▪ Production cost is forecasted to be extremely low compared to

selling price

▪ Novartis Patent expired (2017)

Status of Current Development

▪ We can gain major maker share through price competiveness

and best quality in emerging markets

▪ In the Korean market, the product will be launched through an

alliance with a domestic pharmaceutical company

▪ For overseas markets, exports target where the company’s

partners are: Eastern Europe, Brazil, Middle East, Southeast

Asia and Turkey

Market entry strategy

▪ Will begin pre-clinical trial as soon as possible

Entry barrier

▪ It can be produced by recombinant E.coli

▪ Production is possible immediately away without additional

investment in facilities

Fig. Proportion of Elderly Population by Country (Aged 65 years and over)

Source: Statistics Bureau, MIC, Ministry of Health, Labor and Welfare; United

Nations.

Biopharmaceuticals : Ranibizumab

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• Sang Mok Lee, CEO & President, Director

Dr. Lee has been a President and CEO since the inception in 2005. Dr. Lee holds a PhD in microbiology from Busan National

University in Korea and is currently an adjunct professor in microbiology at Chungnam National University. Dr. Lee is a

committee member for the hi-tech medical complex city in Daejon, Korea and a committee member of KOFST (the Korean

Federation of Science and Technology Societies).

• Konstantin Lichtenwald, CFO, Director

Mr. Lichtenwald has over ten years of finance and accounting experience, including corporate compliance, accounting and

financial management and IPO, RTO services. Mr. Lichtenwald offers extensive knowledge and know-how for companies in

two key financial jurisdictions, North America and German speaking parts of Europe. His accounting, financial skills offer a

multi-faceted hands on approach to strategic management and problem solving. Mr. Lichtenwald earned his bachelor of

business administration degree from Pforzheim University, Germany, and holds the professional designation of Chartered

Professional Accountant (CPA, CGA) and Chartered Certified Accountant (ACCA), where he is a member of Chartered

Professional Accountants of B.C. and Canada as well as a member of the Association of Chartered Certified Accountants of

United Kingdom.

• Collin (Sang Goo) Kim, Director

Mr. Kim holds a bachelor degree of business administration from Korea University, Seoul, Korea. Mr. Kim came to Vancouver, Canada in 2006

after working for Hanwha Corp., one of Korean business conglomerates for 16 years, where he was dedicated to International trading business for

various industrial products. He has been working as a Vice President for Columbia Capital since 2008 and a director of ArcPacific Resources

Corp., a public Canadian junior exploration company, since 2015. He is imperative in the communication between Korean management and

Canadian management cross the border with his vast knowledge and work experience.

The Team

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• Hans Frykman – Director

Dr. Hans Frykman is the current medical director of Neurocode Labs in Vancouver and UBC Diagnostic Services Lab. Neurocode is world

leading in the field of neurogenetics accepting difficult adult and pediatric neurology cases from Asia, North America and Europe. It is Canada’s

first and only clinical whole exome sequencing laboratory. Also, Neurocode has a best in class software product linking genotype to phenotype in

the area of neurogenetics. UBC Diagnostic Services Lab is Canada’s leading clinical Neuroimmunology laboratory servicing all provinces with this

highly complex testing. Under Dr. Frykman’s guidance, the UBC Diagnostic Services lab has expanded fourfold. Dr. Frykman has a medical

degree from Karolinska Institute in Stockholm, a PhD in Biocatalysis at Royal Institute of Technology, and post graduate medical training from

Karolinska University Hospital Solna Campus, Mayo Clinic, University of Minnesota, Memorial Sloan Kettering and University of British Columbia

in the areas of internal medicine, oncology, clinical pathology, molecular genetics and medical biochemistry. Dr. Frykman held reaearch positions

with the US Government, Astra Zeneca, Akzo Nobel and Novo Nordisk. Early in his career he was part of the discovery teams around Victoza and

Losec(Prilosec). He is licensed to practice medicine in Sweden and British Columbia.

• Danny Joh – Director

After completing a PhD in Biochemistry at Texas A&M university and an MBA at Rice University, Danny Joh moved to the San Francisco area to

build a career in the biopharma industry. For twenty years, he has expanded his biopharma product development and cross-functional program

management experiences while working for major biopharma companies, including Chiron, Genentech, Biomarin, Sangamo and other biotech

companies in the San Francisco area. His experience spans from early to late stage product development in various platforms, including

biologics, small molecules, and gene therapy across many therapeutic areas, including cancer and rare genetic disorders. He joins the Board of

Directors of BioCure Technologies in March, 2019.

• The Company also has a very strong Advisory Board comprised of Medical Professionals that have key industry contacts and

alliances. For their full Bio’s and Summary of expertise please refer to our website.

The Team

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E-mail : [email protected]

Thank you.

IR version – April 2019