Financial Results Q3 FY12/17newsml:td… · concluded on September 27, 2017. Chiome has granted...

Copyright © 2017 Chiome Bioscience Inc. All Rights Reserved.

Chiome Bioscience Inc.

Nov 14, 2017

Financial Results

Q3 FY12/17

Securities code : 4583

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

Agenda

◆Overview of Q3 FY12/17 “Financial results”

◆Overview of Q3 FY12/17 “Operation highlights”

◆ Others


Financial results: Profit and Loss(¥million)

175

1,002

489 512

▲ 827 ▲ 827

▲ 964

186

761

321

439

▲ 574 ▲ 575 ▲ 574

▲ 1,200

▲ 900

▲ 600

▲ 300

0

300

600

900

1,200

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

3QFY12/16 Result 3QFY12/17 Result


Cash on hand and

in banks 4,352

Net assets4,525

Liabilities 184

Net assets4,565

4

Financial results: Balance Sheet

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

Other non-current assets 201

Other current assets 131

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

Property, equipment and Intangible assets 25


Agenda



◆Others


Operation highlights (1)

【Drug Discovery and Development Business Segment】

• Execution of License Agreement for LIV-1205

License Agreement with ADC Therapeutics SA (ADCT) was

concluded on September 27, 2017.

Chiome has granted ADCT a worldwide exclusive license with a

right to sublicense, develop, manufacture, and commercialize an

ADC format of LIV-1205, which is coded “ADCT-701”.

ADCT will proceed ADCT-701 to development stage.

Chiome will receive

- milestone payments when ADCT reaches each development

milestone.

- predetermined sales-tied royalty after launch.


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

Preclinical evaluation in pediatric cancer models are ongoing under

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

National Cancer Institute (NCI).

Chiome will continue development work on LIV-1205 towards

clinical stage to increase its product value.



Promoting in-house clinical development

ProBioGen will develop a stable GlymaxX® cell line,

followed by process development and GMP manufacturing.

About ProBioGen AG （http://www.probiogen.de/）

Founded in 1994, Germany-based ProBioGen has abundant

experience in the manufacture of investigational antibody drugs, and

possesses the GlymaxX® technology, a proprietary ADCC

enhancement platform by modification of fucose synthesis pathway

Chiome selected ProBioGen AG as a contract partner for the

manufacture of investigational drugs for clinical development.

Advancing in-house clinical development and discovery programs.

http://www.probiogen.de/



【Drug Discovery Support Business Segment】

• 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 for

Mitsubishi Tanabe Pharma Corporation group.

• Launch antibody selection projects with other pharmaceutical

companies.


23%

77%

10


【Net sales of Drug Discovery Support (DDS)】

• Drug Discovery Support Business posted net sales of 143,716 thousand yen through 3Q.

• Sales can be broken down to Chugai Pharmaceutical Group and Mitsubishi Tanabe Pharma Corporation group etc.

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

• Drug Discovery and Development Business posted net sales of 42,694 thousand yen through 3Q.

• Upfront payment of the License Agreement with ADCT was posted.

186

【R&D progress】

• Continuation of research activities for refining antibody discovery technology including the ADLib® system and accumulating further cases of antibody generation.

• Perform several antibody drug discovery projects focusing on cancer, immune, and central nervous system diseases. (¥ million)

DDS

DDD

Net sales

1-3Q cumulative


Development timeline and revenue model

11

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

Sales milestone

Royalty

BMAA

Self-development or

Licensing

Licensee

LIV-1205

LIV-2008


Project TargetTherapeut

ic area

Basic

ResearchPre-clinical studies Clinical trials Partner

LIV-1205

ADCDLK-1 Oncology

LIV-1205 DLK-1 Oncology ー

LIV-2008 TROP-2 OncologyLooking for

partners

LIV-

2008bTROP-2 Oncology

Looking for

partners

BMAA SEMA3A UndisclosedLooking for

partners

New PJ Undisclosed

Pipeline

ADCTADCT will proceed the development as ADCT-701

In-house clinical development

12


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,EP,CN (patent applied for JP,

others)

JP, US, CN(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~Sept. 30, 2017): JPY1.7 billion

Total number of dormant stocks: 1,347

Focus on investment to bolster corporate value

14

Use of funds Cost（million JPY）Scheduled period of

spending

Development works to 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


Agenda



◆Others


Advisory board

To guarantee objectivity and transparency in management

16

【Goal】To provide non-binding strategic advice based on objective assessment of

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 status】From May 24, 2017 though Novmber 14, 2017

Verifying our business and timely disclosure.


Vision

Following feedback from advisory board, new

vision and business plans are going to be

discussed under new management team.

17


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

19

• 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 Q3 FY12/17newsml:td… · concluded on September 27, 2017. Chiome has granted...

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