financial results q2 fy12/17therapeutics sa (adct), and the following notification was received on...

Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved.

Chiome Bioscience Inc.

Aug 10, 2017

Financial Results

Q2 FY12/17

Securities code : 4583

Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved. 2

Agenda

◆Overview of Q2 FY12/17 “Financial results”

◆Overview of Q2 FY12/17 “Operation highlights”

◆ Others


Financial results: Profit and Loss(¥million)

130

713

346 366

▲ 582 ▲ 580

▲ 711

102

491

197

293

▲ 388 ▲ 389 ▲ 389

▲ 800

▲ 600

▲ 400

▲ 200

0

200

400

600

800

Net sales COGS / SGA R&D expenses Other costs Operating income Ordinary income Net income

2QFY12/16 Result 2QFY12/17 Result


Net assets4,710

Net assets4,565

4

Financial results: Balance Sheet

As of December 31, 2016 As of June 30, 2017（¥million）

Other non-current assets 22３

Other current assets 125

Liabilities 178

Other non-current assets 72

Other current assets 128

Property, equipment and Intangible assets 35

Liabilities 224

Cash on hand

and

in banks

4,553

Cash on hand

and

in banks

4,512

Property, equipment and Intangible assets ２８


Agenda



◆Others


Operation highlights (1)

【Drug Discovery and Development Business】

• Option agreement

Under the option agreement, the evaluation of LIV-1205 and LIV-

2008b as antibody-drug conjugate (ADC) was completed by ADC

Therapeutics SA (ADCT), and the following notification was received on

June 26, 2017.

Option right Future Plans

LIV-1205 Exercise

・ADCT will continue preclinical and

future clinical development.

・Formal license agreement to be

determined.

LIV-2008b Not exercise　Chiome will continue development and

licensing efforts.


Exercising option right to LIV-1205

ADCT will proceed with R&D activities for LIV-1205 as an ADC

About ADC Therapeutics SA （http://www.adctherapeutics.com/）

A Switzerland-based, clinically-staged company specialized in

the development of ADCs in oncology field.

Four ADC molecules in the clinical development with one

licensed-out to MedImmune.

* Antibody-drug conjugated (ADCs) are

monoclonal antibodies attached to biologically

active drugs by chemical linkers. By combining

the unique target specificity of antibody with

cytotoxic compound, ADCs are delivered

specifically to disease area and exhibits potent

antitumor effect.Antibody

Anticancer drug etc.

ADC concept

Chiome grants a worldwide, exclusive license to ADCT to develop,

manufacture, sale, and sublicense an ADC format of LIV-1205.

http://www.adctherapeutics.com/



【Drug Discovery Support Business】

• Efforts are made to provide better services on the collaborative and

contract R&D activity with Chugai Pharmaceutical Group as a primary

source of revenue.

• Perform antibody selections by utilizing the ADLib® system with

Mitsubishi Tanabe Pharma Corporation group.

• Launch antibody selection projects with other pharmaceutical companies.

LIV-1205 (Humanized anti-DLK-1 monoclonal antibody): Naked antibody

• Preclinical evaluation in childhood cancer models are ongoing under the

Pediatric Preclinical Testing Program (PPTP) funded by the U.S. National

Cancer Institute (NCI).

• Preparative work for in-house clinical development has been initiated.



【Net sales of Drug Discovery Support (DDS)】

• Net sales from Drug Discovery Support Business through

2Q were posted in net sales of 99,488 thousand yen.

• Sales can be broken down to Chugai Pharmaceutical Group

and Mitsubishi Tanabe Pharma Corporation group etc.

【Net sales of Drug Discovery and Development (DDD)】

• Upfront payment of the License Agreement with ADCT are expected to be

posted after 3Q

102

【R&D progress】

• Perform antibody selections using the human ADLib® system while

refining the technology.

• Perform several exploratory antibody drug discovery projects.

3%

(¥ million)

DDS

97%

DDD

Net sales

1-2Q cumulative


Development timeline and revenue model

10

Pre-clinical studies Clinical trails Launched Sale

PhaseI

PhaseII

PhaseIII

BLA

application

Approval

2～3 years 5～7 years 1～2 years

Net

sale

0

LIV-1205 ADC

LIV-2008b ADC

Sales milestone

Royalty

BMAA

Self-development

or

Licensing

Licensee

LIV-1205

LIV-2008

Chiome will receive upfront

payment following execution of

the finalized License Agreement

for LIV-1205


Project TargetTherapeutic

area

Basic

ResearchPre-clinical studies Clinical trials Partner

LIV-1205

ADCDLK-1 Oncology

LIV-1205 DLK-1 OncologyLooking for

partners

LIV-2008 TROP-2 OncologyLooking for

partners

LIV-2008b TROP-2 OncologyLooking for

partners

BMAA SEMA3A UndisclosedLooking for

partners

New PJ Undisclosed

Pipeline

11

ADCT

ADCT will proceed the development

Prepare for in-house clinical development


Profile : LIV-1205・LIV-2008/2008b

LIV-1205(Humanized anti-DLK-1 antibody)

LIV-2008/2008b(Humanized anti-TROP-2 antibody)

Target DLK-1 TROP-2

High expression

cancer

Liver cancer, lung cancer, neuroblastoma

etc.

Breast cancer (TNBC), lung cancer,

colorectal cancer etc.

Novelty of target Novel target Known target

Competitor N/A ADC (IMMU-132, Immunomedics)

Patent US (patent applied for JP, EP, others) JP, US (patent applied for EP, Others)

Efficacy in human Unknown IMMU-132 has demonstrated clinical

efficacy

Expectation First-in-class therapeutic antibody

targeting intractable cancers

Best-in-class therapeutic antibody targeting

breast cancer (TNBC), lung cancer etc.

Naked antibody LIV-1205 exhibited a noticeable inhibitory

effect on tumor growth using animal

model in single administration

Potent anti-tumor activity has been

observed in various cancers in single

administration of naked antibody (LIV-2008)

using animal model.

Fitness for ADC LIV-1205 has internalization activity LIV-2008b has internalization activity

TNBC: Triple-negative breast cancer

Internalization: A phenomenon that antibodies being taken into cells after binding to the antigen



【Others】

• Summary of financing status through third-party allotment

Total amount of funds (Sept. 16, 2016~June 30, 2017): JPY1.7 billion

Total number of dormant stocks: 1,347

Focus on investment to bolster corporate value

13

Use of funds Cost（million JPY）Scheduled period of

spending

Preparative works for IND submission

and early-phase clinical development1,300 Jan. 2017～Dec. 2019

Expansion and in-licensing of new

pipelines300 Dec. 2016～Dec. 2018

Investment in/ M&A for companies with

advanced technologies for synergism1,294 Oct. 2016～Dec. 2018

・To secure efficient operation, the headquarter office space has been downsized, and the accompanied gain or loss from sales of fixed assets was posted as extraordinary profit and loss.


Agenda



◆Others


Advisory board

To guarantee objectivity and transparency in management

15

【Goal】

To provide non-binding strategic advice based on objective assessment

business management.

To verify and evaluate business plans and decisions both prospectively and

retrospectively.

Cl

【Member】

* Shinya Fukuzaki (Lawyer)

Shiro Toba (Certified public accountant)

Jun Yoshino (Patent attorney)

*Head of advisory board

【Activity condition】

From May 24, 2017 though August 8, 2017

Verifying our business and timely disclosure.


Vision

Effectively utilizing feedback from advisory board,

to reconstruct business objective and plan under

new administration.

16


Ethics & Transparency

Evolution & Creation

Chiasma & Global Exchange

We strive to be a sound, well-respected company that values human life.

We strive to create the future through the development of each person and the

company as a whole.

We are committed to the transcendence of national and international borders.


Disclaimer

18

• Materials and information provided during this presentation may contain so-called “forward-looking statements.” These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements.

• Risks and uncertainties include general industry and market conditions, and general domestic and international economic conditions such as interest rate and currency exchange fluctuations.

• The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

financial results q2 fy12/17therapeutics sa (adct), and the following notification was received on...

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