INTRODUCTION TO

SOSEI GROUP

July 2017

Sosei Group Corporation

ムスカリンM1作動薬HTL0018318

に関するお知らせ

18 September 2018

Disclaimer

The material that follows is a presentation of general background information about Sosei Group Corporation and its subsidiaries (collectively, the “Company”) as of the date of this presentation.

This material has been prepared solely for informational purposes and is not to be construed as a solicitation or an offer to buy or sell any securities and should not be treated as giving investment

advice to recipients. It is not targeted to the specific investment objectives, financial situation or particular needs of any recipient. It is not intended to provide the basis for any third party

evaluation of any securities or any offering of them and should not be considered as a recommendation that any recipient should subscribe for or purchase any securities.

The information contained herein is in summary form and does not purport to be complete. Certain information has been obtained from public sources. No representation or warranty, either

express or implied, by the Company is made as to the accuracy, fairness, or completeness of the information presented herein and no reliance should be placed on the accuracy, fairness, or

completeness of such information. The Company takes no responsibility or liability to update the contents of this presentation in the light of new information and/or future events. In addition, the

Company may alter, modify or otherwise change in any manner the contents of this presentation, in its own discretion without the obligation to notify any person of such revision or changes.

This presentation contains “forward-looking statements,” as that term is defined in Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act

of 1934, as amended. The words “believe”, “expect”, “anticipate”, “intend”, “plan”, “seeks”, “estimates”, “will” and “may” and similar expressions identify forward looking statements. All

statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of

management for future operations (including development plans and objectives relating to our products), are forward looking statements. Such forward looking statements involve known and

unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements

expressed or implied by such forward looking statements. Such forward looking statements are based on numerous assumptions regarding our present and future business strategies and the

environment in which we will operate in the future. The important factors that could cause our actual results, performance or achievements to differ materially from those in the forward looking

statements include, among others, risks associated with product discovery and development, uncertainties related to the outcome of clinical trials, slower than expected rates of patient

recruitment, unforeseen safety issues resulting from the administration of our products in patients, uncertainties related to product manufacturing, the lack of market acceptance of our products,

our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or

lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other

factors. These factors include, without limitation, those discussed in our public reports filed with the Tokyo Stock Exchange and the Financial Services Agency of Japan. Although the Company

believes that the expectations and assumptions reflected in the forward-looking statements are reasonably based on information currently available to the Company's management, certain

forward looking statements are based upon assumptions of future events which may not prove to be accurate. The forward looking statements in this document speak only as at the date of this

presentation and the company does not assume any obligations to update or revise any of these forward statements, even if new information becomes available in the future.

This presentation does not constitute an offer, or invitation, or solicitation of an offer, to subscribe for or purchase any securities. Neither this presentation nor anything contained herein shall form

the basis of any contract or commitment whatsoever. Recipients of this presentation are not to construe the contents of this summary as legal, tax or investment advice and recipients should

consult their own advisors in this regard.

This presentation and its contents are proprietary confidential information and may not be reproduced, published or otherwise disseminated in whole or in part without the Company’s prior

written consent. These materials are not intended for distribution to, or use by, any person or entity in any jurisdiction or country where such distribution or use would be contrary to local law or

regulation.

This presentation contains non-GAAP financial measures. The non‐GAAP financial measures contained in this presentation are not measures of financial performance calculated in accordance

with IFRS and should not be considered as replacements or alternatives profit, or operating profit, as an indicator of operating performance or as replacements or alternatives to cash flow

provided by operating activities or as a measure of liquidity (in each case, as determined in accordance with IFRS). Non-GAAP financial measures should be viewed in addition to, and not as a

substitute for, analysis of the Company's results reported in accordance with IFRS.

References to "FY" in this presentation for periods prior to 1 January 2018 are to the 12-month periods commencing in each case on April 1 of the year indicated and ending on March 31 of the

following year, and the 9 month period from April 1 2017 to December 31 2017. From January 1 2018 the Company changed its fiscal year to the 12-month period commencing in each case on

January 1. References to "FY" in this presentation should be construed accordingly.

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HTL0018318臨床開発を自主的に中断

➢ 当社とAllergan社は、安全性上の予防的措置としてHTL0018318の臨床開発を自主的に中断

➢ サルを対象にした長期毒性試験において予期しない毒性所見が見出された

➢ 患者さまを対象とした臨床試験での被験者における有害事象に基づくものではない

➢ 当社の他の提携および自社開発パイプラインに影響を及ぼすものではない

➢ 株主さまにとって大きな価値を生み出す複数のパイプラインがある

当社は革新的な医薬品を患者さまに提供するという長期的な目標を堅持します

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本件によって影響を受ける試験

➢ 以下の試験で最短でも6ヶ月の遅れが生じる

• 米国での第Ⅰ相試験（治験実施社：Allergan社）

• 日本でのレビー小体型認知症患者を対象とした第Ⅱ相試験（治験実施社：当社子会社HeptaresTherapeutics, NCT03592862）

➢ 当社およびAllergan社は、米国食品医薬品局（FDA）、医薬品医療機器総合機構（PMDA）および、すでに臨床試験が完了している他の国の規制当局に対して、当該毒性所見と進行中の臨床試験の一時中断を報告済み

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当社は患者さまの安全を最も重要と考えます

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財務への影響は限定的

➢ 契約に従い、本件に関する調査の費用はAllergan社が負担

➢ 2018年12月31日までの9ヶ月間において

• 外部委託費の減少による研究開発費の減少—現金収入の改善が見込まれる

➢ 開発の自主的中断が、自動的に資産やのれんの減損につながることはない

➢ 財務への影響については現在精査中であり、2018年11月8日開示予定の第2四半期決算で報告

➢ 次年度の収益への影響――パートナー契約したアルツハイマー認知症を対象としたM1作動薬の開発進捗に関するアラガン社からのマイルストン収益は2019年には見込めない

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当社の資本基盤は強く、保有する約220億円の現金により2020年までの十分な経営資金を確保

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製品/プログラム モダリティ1 適応 パートナー 探索 前臨床 第1相 第2相 第3相 上市

提携GPCRパイプライン (伝統的導出型モデル/共同研究プロジェクト)

M1 SME アルツハイマー病

M4 SME アルツハイマー病

M1/M4 SME アルツハイマー病

A2a +/- anti-PD-L1 SME がん免疫療法

A2a + anti-CD73 SME がん免疫療法

複数ターゲット SME 疼痛

複数ターゲット SME/MAB 複数

複数ターゲット MAB 非開示

提携パイプライン (共同開発/利益配分モデル)

複数ターゲット PEP 炎症性疾患

複数ターゲット MAB がん免疫療法

提携パイプライン- 呼吸器関連製品群 (伝統的導出型モデル)

Seebri®/Ultibro® SME COPD

QVM149 SME 喘息

1 注: SME = 低分子; PEP = ペプチド; MAB = モノクローナル抗体

複数の疾患領域において、パイプラインを保有一つのパイプラインに依存しない、バランスのとれた多角的ビジネスモデル

: 向こう12－18ヶ月の進捗予定

: 現在

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自主的に中断

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プログラム モダリティ1 適応 パートナー 探索 前臨床 第1相 第2相 第3相 上市

M1 SME DLB (日本)

mGlu5 SME 神経系疾患

CGRP SME 偏頭痛

SSTR SME 内分泌疾患

GLP-1 SME 代謝性疾患

GLP-2 SME 腸管不全

In-house pipeline

1 Note: SME = small molecule

上市に向けて、複数の自社開発プログラムが進行中難病/希少疾患にフォーカスしたパイプラインを構築

複数の候補品が臨床試験へステージアップする見通し

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自主的に中断

: 向こう12－18ヶ月の進捗

: 現在

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今回の毒性所見は、臨床試験で設定された用量、期間を上回る量の投与で観察された

➢ サルに対して異なった用量で9ヵ月間の投与を行った動物毒性試験で、希少な腫瘍が観察された

➢ 他の動物に対する毒性試験では、6か月間までの投与で毒性事象は観察されていない

➢ HTL0018318の臨床試験は、これまで米国・欧州で健康成人および軽～中度アルツハイマー病患者を含む約310人の被験者を対象に行われた

➢ 臨床試験のデータからは、当化合物の忍容性は良好であり、設定された用量での28日間投与では有害事象は確認されていない

当社およびAllergan社の研究者が試験結果の精査を行っています

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均衡の取れたビジネスモデル

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1 Stabilized receptor technology

2 Structure-based drug design

G-タンパク質共役受容体（GPCRs）

自社開発

共同開発型

導出型

StaR®1 技術+

構造ベース創薬（SBDD2）

プラットフォームM1 mGlu5

SSTRCGRP

GLP-1 GLP-2

+ Multiple other targets

自社に最適な戦略が取れる開発権利を保持

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日本初の国際的なリーディングバイオ製薬企業を目指して

➢ GPCRにフォーカスした創薬の世界的リーダー： 独自のStaR®技術、SBDDプラットフォームを持つ

➢ 提携パイプライン：神経系疾患、免疫－炎症系疾患、中枢神経系疾患等を対象に臨床試験を進め、市場規模は50億ドル強のポテンシャル

➢ 自社開発パイプライン：難病／希少疾患に重点を置き、複数のプログラムを臨床開発に進めることを目指す

➢ saRNAへの戦略的投資：肝癌、希少疾患を対象に第1相/第2a相臨床試験を進める

➢ 呼吸器系疾患治療薬の堅調なロイヤリティー収入：増資に頼らない安定的な収入源

➢ 220億円の強固なキャッシュポジション：グロバール成長戦略を支える

1 Stabilized receptor technology2 Structure-based drug design

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12 CEBPA - C Enhancing beta Protein Alpha

そーせいグループ株式会社

所在地

東京都千代田区麹町2-1

PMO半蔵門11F102-0083

HEPTARES THERAPEUTICS

BioPark, Broadwater Road

Welwyn Garden City

Hertfordshire AL7 3AX United Kingdom

Grabenstrasse 11a,

CH-8952 Schlieren Zürich,

Switzerland

www.sosei.com www.heptares.com