Chiome Bioscience : Supplement Documents for Financial Results Q2 FY12/20

August 11, 2020 at 03:04 am EDT

Supplement Documents for Financial Results Q2 FY12/20

Aug 11, 2020

To accelerate drug discovery and development of mAb for therapeutics to overcome current medical unmet-needs

Chiome Bioscience Inc.

Agenda	2

１．Overview of Q2 FY12/20 "Financial results"

２．Overview of Q2 FY12/20 "Operation highlights"

Appendix.

Corporate information

Pipeline information

Overview of

Q2 FY12/20 "Financial results"

Financial results: Profit and Loss

(JPY in millions)

	Q2 FY2019	Q2 FY2020	Increase
	(decrease)


Net sales	140	173	32

Drug Discovery &	1	1	0
Development

Drug Discovery	139	171	32	• Growth in business with domestic
Support				pharmaceutical companies

COS/SGA	890	909	18

R&D Expense	636	608	(27)	• Cost of GLP toxicology study and
drug manufacturing and CRO for
				CBA-1205
Other costs	254	300	46	• Costs of the expansion of laboratories
				and increasing equipment.
Operating Loss	(749)	(735)	(13)

Ordinary Loss	(758)	(735)	(22)
Net Loss	(757)	(736)	(21)

Financial results: Balance Sheet

		(JPY in millions)

	As of Dec. 31, 2019	As of Jun. 30, 2020

Current assets	2,561	2,804

（Cash on hand in banks)	2,105	2,472
(Other current assets)	456	332

Non-current assets	247	249

Total assets	2,808	3,054

Current Liabilities	145	427
Non-current liabilities	41	41

Total liabilities	186	468

Total net assets	2,621	2,585

Total liabilities and net assets	2,808	3,054

Financial results: Cash Flows	6

(JPY in millions)

	Q2 FY2019	Q2 FY2020

Cash flows from operating activities	(677)	(528)
Cash flows from investing activities	－	－
Cash flows from financing activities	1,248	894
Net increase (decrease) in cash and cash equivalents	570	366
Cash and cash equivalents as of the beginning of the year	2,328	2,105
Cash and cash equivalents as of the end of the year	2,899	2,472

【Cash flows from operating activities】

・Expenses for GLP toxicology study, drug Manufacturing and CRO for CBA-1205.

【Cash flows from financing activities】

・Proceeds from issuance of shares resulting from exercise of subscription rights to shares

SMBC Nikko Securities Inc.

Overview of

Q2 FY12/20 "Operation highlights"

Business Segment	8

Drug Discovery and Development Business

To discover and develop novel antibody drugs in-house or in collaboration with a partner up to late pre-clinical stage which enables to prepare data package for IND or early clinical stage in therapeutic areas where high unmet medical needs exist. The drug candidates will be out-licensed to pharmaceutical company under appropriate financial conditions such like upfront, milestone, and royalty payments etc.

Drug Discovery Support business

To provide "fee-for-service" to pharmaceutical and diagnostics company, and

academia to support their research works. Main line of this business is 1) to generate a monoclonal antibody for their targets by our proprietary platform, and 2) to express, culture, and purify proteins including antigen and antibody.

Pipeline

Out-Licensed Product

Code

Target

Therapeutic

Basic research,

Preclinical

Clinical Trials

Partner

Area

Drug Discovery

Study

ADCT-701

DLK-1

Oncology

（LIV-1205 ADC）

/ADC

Pipelines

Project

Target

Therapeutic

Basic research,

Preclinical

Clinical Trials

Status

Area

Drug Discovery

Study

CBA-1205

DLK-1

Oncology

Phase 1

（ADCC enhanced）

CBA-1535

5T4×CD3

Oncology

GMP

（

）

×5T4

manufacturing

Tribody

LIV-2008

TROP-2

Oncology

Licensing

/2008b

opportunity

BMAA

SEMA3A

DME, Others

SemaThera

(Exclusive option

agreement)

Discovery PJ

Oncology

－

Undisclosed

infectious/

（6）

rare diseases

As of Jul.31,2020

Pipeline	10

CBA-1205

Humanized afucosylated

anti-DLK1 antibody

A contract to conduct Phase I Study of CBA-1205 between Chiome and 2 sites of National Cancer Center Hospital (Center and East) have concluded in July.
The first patient has already been dosed in early August.

CBA-1535

Humanized anti 5T4/WAIF1

antibody, multi-specific antibody

CMC development progressed on track towards CTA submission in the UK in the second half of 2021 onwards.
Patent was granted in Japan on Apr. 22.

LIV-2008

Humanized anti-TROP2

antibody

BMAA

Humanized anti-

Semphorin3A antibody

Discovery PJ

ADCT-701

Out-Licensed Product

Under evaluation for in-licensing by several pharmaceutical companies.
Being evaluated by SemaThera Inc. under Collaborative Development License and Exclusive Option Agreement concluded in March 2018.
Filed a new patent application for an oncology project.
Initiated collaboration with bio-ventures and academia for new discovery projects.
ADC Therapeutics is continuing preparations for an IND.
IND is expected to be submitted in 2020 or afterwards.

Pipeline	11

Phase I clinical trial of CBA-1205

Recruitment of first patient

In July, Chiome and 2 sites of National Cancer Center Hospital (Center and East) have concluded a contract to conduct Phase I Study of CBA-1205. The first patient has already been dosed in early August. In this study, initially, patients with solid tumor who have no standard treatment, or are refractory or intolerant to standard treatment are enrolled.
In the first part of the trial, safety and tolerability in patients with solid tumor will be evaluated. In the expansion part, safety and efficacy at the recommended dose in patients with advanced and/or recurrent hepatocellular carcinoma will be evaluated.

＜Registration in Japan Pharmaceutical Information Center database＞

Technology Platform	12

Human ADLib® system

Japanese patent registration / Publication

The patent of human ADLib® system was granted in Japan.

Japanese patent titled "Cells for producing human antibody" which consists our proprietary antibody platform technology has been granted in June 2020.

The paper of human ADLib® system has been published.

Achievement of collaborative research with Univ. of Tokyo about proof of concept and applicative research of human ADLib® system has been published in peer-reviewed international journal.

Title :

Streamlined human antibody generation and optimization by exploiting designed immunoglobulin loci in a B cell line

Highlight :

Here, we report the development of a human version of the ADLib system and showcase the streamlined generation and optimization of functional human mAbs.

From human ADLib antibody libraries, clones producing full-length human IgGs against distinct antigens such as VEGF and TNFα can be isolated, as exemplified by the selection of antagonistic mAbs. Effective affinity maturation was achieved in a straightforward manner by seamless diversification of the parental clones into secondary libraries followed by single-cell sorting, quickly affording mAbs with improved affinities and functionalities.

Journal : Cellular & Molecular Immunology（Online）

https://www.nature.com/articles/s41423-020-0440-9

Drug Discovery Support	13

Business with pharmaceutical companies, etc.

Sales increased by 23% year-on-year due to growth of business with domestic pharmaceutical companies.
- Despite temporal slowdown in business activity at Chiome and clients following the Declaration of Emergency due to pandemic of COVID-19, the impact on sales in this period due to COVID-19 was limited.

	Sales for Drug Discovery Support business
200	23% increase	(JPY mn)
150

100

2Q/2018 2Q/2019 2Q/2020

Contract antibody generation projects against COVID-19 in progress. Recorded sales for projects completed in this quarter.
Expansion of laboratories and equipment in anticipation of increasing inquiries from customers.

Financing	14

Issued series 17th Subscription Rights to Shares to SMBC Nikko Securities Inc. On May. 27, 2020.

＜Use of funds＞

to expand pipeline for continuous deliver innovative drugs
to enhancement of technology platform

Use of funds		Cost	Scheduled period of
	(million JPY)	spending


① Pre-clinical study for a new ADC pipeline	and
research on discovery projects in oncology	and	1,764	Jul.2020-Dec.2022
infectious/rare diseases.

②Development of new pipeline by utilizing multispecific	250	Jul.2020-Jun.2022
antibody generation technology (Tribody™)


③ Acquisition of new antibody generation technologies	400	Jan.2021-Dec.2022
and new pipelines.

Status of Exercise(as of end of July 2020) ＞

Total number of shares exercised: 3,352,200/7,000,000 shares (47.9% )

Total value exercised: 1,060 million yen

COVID-19 Business Impact	15

Despite changes, delays, and postponements of some operations made by the Company and its customers due to the spread of COVID-19, impact on the financial performance in this period was limited.

The Company's performance might be affected if the pandemic continues for a long period of time, causing the Company, research institutes, and business partners to suspend their businesses, close facilities, or delay procedures by authorized agencies in the country or region in which the Company conducts business.

The Company is currently conducting business under a business contingency plan that includes remote working and flexible work shift to cope with the spread of COVID-19.

Appendix. Corporate information

Corporate Overview	17

Biotech company dedicating to satisfy unmet medical needs

Mission

	Shine light on unmet needs.
Miｓｓｉｏｎ	Bring a brighter future to patients.

Vision

Will become No. 1 biotech venture

Ｖｉｓｉｏｎ that discovers and develops antibody drugs for unmet medical needs

Management principle

Place the highest priority on sound management and credibility and aim to become a corporation that grows with society.
With creativity and science, develop therapeutic drugs for unmet medical needs, and contribute to the health of patients.
Achieve successive product pipelines and improvement of corporate value through collaboration with external institutions.

■ Founded: February 2005

■ Listed on the stock exchange: December 2011

(Tokyo Stock Exchange Mothers Section)

■ President and Chief Executive Officer: Shigeru Kobayashi, M.E.

■ Location：

＜Head Office and Research Laboratories＞ 3-12-1Honmachi,Shibuya-ku, Tokyo

＜Drug Discovery Laboratories＞ 2-13-3 Nogawahonchou, Miyamae-ku,Kawasaki-city, Kanagawa

■ Number of Employees： 56 （As of Jun. 30 ,2020)

■ Business：

Chiome Bioscience (4583.T), is a public company leveraging a proprietary monoclonal antibody generating technology, for drug discovery and development, as well as providing drug discovery supports.

Core competence for developing business	18

Technology Platform（Chiome's mAb Discovery Engine）

Preparation of		MAb Generation			MAb Engineering
recombinant proteins		Platform

Expression		ADLib®system			Affinity maturation
Recombinant						Functional evaluation

proteins
		Animal immunization		Multi-specific antibody
Purification
Membrane						Lab-scale
proteins		B cell cloning	Hybridoma
			mAb production

Chiome possesses antibody platforms including its proprietary technology, and extensive know-hows and experiences in protein/antibody engineering to streamline the process of drug discovery.

This enables us to contribute in

	Drug Discovery and		Drug Discovery Support
	Development


	Development of therapeutic drug		Contract service for drug
		discovery
	and diagnostic agent


Copyright © 2020 Chiome Bioscience Inc. All Rights Reserved.

Revenue Model	19

Drug development process and Chiome's revenue model

	2-3years	5-7years	1-2years
Basic research,	Preclinical	Ⅰ Ⅱ Ⅲ	Regulatory	Launch

Drug Discovery	Study	Clinical Trials	Approval	in market

Discovery Drug

Revenues by licensing-out patents of pipeline product and drug candidates to pharmaceutical companies.

Licensing-out

Discovery Drug

Support

Upfront payments

Revenues by providing drug discovery supporting services to pharmaceutical and diagnostics company, and academia.

Contract service

Milestone payments	Royalties
＜Key business accounts＞

	Name of accounts		Entering date

	Chugai Pharmaceutical Co., Ltd.		Jun. 2011
	Chugai Pharmabody Research Pte. Ltd.	Aug. 2012

	Mitsubishi Tanabe Pharma Corporation	Dec. 2016
	Tanabe Research Laboratories U.S.A., Inc.
	Ono Pharmaceutical Co., Ltd.		Oct. 2018
	Kyowa Kirin Co., Ltd.		July 2019

Our stability and growth potential	20

Core technology will sustain continuous development of therapeutic antibody

while offering higher quality of service

Company value


Early stage of	Late stage of	Stable &
growth	growth	Expanded stage

	ADCT-701	Discovery, development, and
	BMAA	out-licensing of pipelines

（ Anti-Sema3A antibody

	Drug Discovery and Development
CBA-1205

CBA-1535Driver of growth

LIV-2008

New pipelines

Drug Discovery Support

Stable earnings

Chiome's mAb Discovery Engine

Time

Appendix. Pipeline information

Pipeline -Out-Licensed-	22

ADCT-701* (Humanized anti-DLK1 antibody ADC)

An Antibody Drug Conjugate (ADC) form of LIV-1205 that was licensed out to Switzerland-based ADC Therapeutics SA in September 2017.
ADCT has completed pharmacology and toxicology studies required for an IND submission and is continuing preparations for an Investigational New Drug Application (IND).

*Chiome 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".

Pipeline -In-house program-	23

CBA-1205（Humanized afucosylated anti-DLK1 antibody) First in class

A humanized antibody generated by hybridoma technology in Livtech which Chiome acquired in 2015.
Therapeutic Area：Liver cancer, lung cancer, neuroblastoma etc.
Patent：Granted in Japan, US, Europe, China etc.
Unmet needs that we should satisfy：Providing new therapeutics for highly malignant tumors without effective therapeutic drugs including hepatocellular carcinoma.

CBA-1535（Humanized anti 5T4 antibody, multi-specific antibody)

CBA-1535is a T-cell engager, trispecific antibody, directed against the 5T4 tumor antigen,
a protein found on various solid tumors and is thought to be involved in metastasis.
Therapeutic Area ：Malignant mesothelioma, small cell lung cancer, non small cell lung cancer, TNBC etc.

	CBA-1535
	（Tribody）
5T4	CD3
Cancer	T cell
cell

Patent： Granted in Japan, Pending in US, Europe etc.

Pipeline -In-house developed-	24

LIV-2008（Humanizedanti-TROP2 antibody)

LIV-2008is a humanized monoclonal antibody targeting cell surface antigen "TROP-
2" which is overexpressed in breast cancer, colon cancer, lung cancer and several types of solid cancers and also expected to play a key role in the proliferation of cancer cells.
Therapeutic Area：Breast cancer (TNBC), lung cancer, colorectal cancer etc.
Patent：Granted in Japan, US, EU, China etc.

BMAA（Humanized anti-Semaphorin3A antibody） First in class

A humanized antibody generated using the ADLib® System.
Chiome has granted SemaThera Inc. an exclusive option right to obtain a worldwide exclusive license to develop the antibody as a therapeutic and/or diagnostic agent.
Therapeutic Area： Diabetic macular edema (DME)
Patent：Granted in Japan, US and Europe etc.

Shine light on unmet needs.

Bring a brighter future to patients.

To accelerate drug discovery and development of mAb

for therapeutics to overcome current medical unmet-needs

Disclaimer

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.

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Chiome Bioscience Inc. published this content on 11 August 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 11 August 2020 07:03:05 UTC

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CHIOME BIOSCIENCE INC.	-8.89%	44.06M
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