Sosei Group Corporation

UBS
Global Healthcare
INTRODUCTION
TO Conference

SOSEI GROUP

21 May 2018
July 2017

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
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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, orcompleteness 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, theCompany 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 Actof 1934, as amended. The words “believe”, “expect”, “anticipate”, “intend”, “plan”, “seeks”, “estimates”, “will” and “may” and similar expressions identify forward looking statements. All
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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 theenvironment 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 orlack 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 otherfactors. 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 thispresentation 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.
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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 are to the Company's fiscal years, namely the 12-month periods commencing in each case on April 1 of the year indicated and ending on March 31 of thefollowing year, unless specifically otherwise indicated.

2

Listed 2004 in Tokyo (TSE Mothers: 4565)

A Japan-listed biotech with a differenceMarket capitalization: c.$1.3bn
Global management team
Main scientific campus in the U.K.

 World-leader in GPCR-focused drug design based on unique IP protected StaR®1 GPCR technology &enabled SBDD2 platform Partnered clinical-stage pipeline in neurology, immuno-oncology, CNS & other diseases, with $5bn plus in
potential economics
 Proprietary pipeline led by dementia with Lewy bodies (DLB) Phase 2 program in Japan, plus multiple
novel candidates in development
 Robust royalties from legacy respiratory products provide source non-dilutive cash flows
 Strong cash position of ~$260m to drive global growth strategy

Global operations and aspirations – aiming to build Japan’s first global biotech champion

33

1 Stabilized receptor technology
2 Structure-based drug designUnique management team for a Japan-listed company
Significant pharma and biotech expertise
Scientific Advisory Board experience

Peter BAINS
Chief Executive Officer

 Former Senior VP of International Commercial

Development at GSK

 CEO and Co-Founder Heptares
 Former Head of Molecular Science Division at

 Former CEO of Syngene

Glaxo Wellcome

Andrew OAKLEY
Chief Financial Officer

Dr. Tim TASKER
Chief Medical Officer

 Former CFO of Actelion Pharmaceuticals Ltd
 Former CFO of Vectura plc

44

Dr. Malcolm WEIR
Chief R&D Officer

 GSK and Former Executive VP of ClinicalDevelopment at Evotec

GPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

Strategic
Investment

Financials

Why do we target G-Protein-Coupled Receptors (GPCRs)?
GPCRs are active in a wide range of disease areas~400
GPCR targets
active in diseases2~34%
of FDA approvals
target GPCRs1

27%
of global sales
are GPCR drugs1

Targeting a new FIC and/or improved BIC GPCR medicines

FIRST OR
BEST-IN-CLASS

BEST-IN-CLASS
Drugged27%

Neurological disorders

Oncology

Gastrointestinal diseases

Cardiovascular

Metabolic disorders

Respiratory

As yetundrugged
56%

Huge opportunity to create new drugs or improve existing drugs
55

In trials
17%

1 Source: “Trends in GPCR in Drug Discovery – new agents, targets and indications”, Nature Reviews, 2017
2 Source: “Unexplored opportunities in the druggable human genome”, Nature Reviews, 2016

FIRST-IN-CLASSGPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

Strategic
Investment

Financials

StaR® is Revolutionary for GPCR Structure-Based Drug Design

StaR® technology stabilizes
and “unlocks” GPCRs

Native GPCRs are unstable,
don’t maintain shape, andare difficult to drug

StaR®
GPCR



Patent-protected
StaR® technology stabilizes
GPCRs on a commercial level

With a StaR® GPCR, thehigh-tech tools of sciencecan develop structures…

Structural information
creates better, differentiateddrug candidates

X-ray Crystallography

physiochemical Improved
properties

Biophysical Mapping Better safety and efficacy
NEW

Cryo-EM… and stable GPCR structures
enable a variety of SBDD
technologies for drug design Reduced clinical attrition
molecule, peptide Smallor antibody discovery

Unique, scalable and sustainable platform, delivering differentiated pipeline candidates
66

GPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

Strategic
Investment

Financials

Leveraging unique GPCR technology to deliver differentiated drug candidatesPartner(Traditional out-licensing /major indications)

GPCRs

StaR®1technology+
SBDD2
platform

Partner(Co-development/
profit share)Advancing

Proprietary(Self-commercialize /rare / orphan / specialty)

M1

mGlu5

SSTR

CGRP

GLP-1

GLP-2

Risk-balanced business model creates and captures optimal value
1 Stabilized receptor technology

77

2 Structure-based drug design

GPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

Advancing a Partnered GPCR pipeline in multiple therapeutic areas
Balanced and diversified
Product/Program

Modality1

Indication

Partner

Discovery

PreclinicalStrategic
Investment

Financials: Current stage: Next 12–18 months progress

Phase 1

Phase 2Phase 3Marketed

Partnered GPCR Pipeline (Traditional out-licensing/collaboration projects)
M1 agonist

SME

Alzheimer’s diseaseM4 agonist

SME

Alzheimer’s disease

M1/M4 dual agonist

SME

Alzheimer’s disease

A2a antagonist

SME

Cancer I/O

A2a antagonist

SME

Cancer I/O

Multiple targets

SME

Pain

Multiple targets

SME/mAb

Multiple indications

Multiple targets

SME

Not disclosed

Partnered GPCR Pipeline (Co-development/profit share)
Multiple targets

PeptideInflammation

Multiple targets

mAb

Cancer I/O

Partnered Pipeline - Legacy Respiratory Products (Traditional out-licensing)Seebri®/Ultibro®

SME

COPD

QVM149SME

Asthma1 Note: SME = small molecule; PEP = Peptide; mAb = monoclonal antibody

88

See slide 9

See slide 11

GPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

Muscarinic M1 Agonist Program for Alzheimer’s disease
A novel approach for symptomatic treatment of AD
HTL0018318 represents a novel approach to stimulating M1

Partnered with:ACh
M2 (–)

N (+)

Choline+acetate Acts directly to stimulate the M1 receptor as an analogueof ACh post the synapse
 Circumvents the underlying neurochemical deficit in

M1

AcCoA
+
cholineChAT– different approach to donepezil
rely on ACh levels in the brain

Financials

Presynaptic cholinergic Neuron Direct stimulation of M1 receptor, mediating cognition HTL0018318 bypasses presynaptic activity, and does not

Strategic
Investment

Acetylcholine (ACh)Alzheimer’s disease patients
HTL0018318
M1 receptor
agonist HTL0018318 offers a potential first-in-class therapy
Selective muscarinic M1 receptor agonism offers apotential first-in-class therapy for AD patients
99

M1 R


M1 R

Postsynaptic Neuron
M1 R

GPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

HTL0018318 is a potential first-in-class therapy for Alzheimer’s disease
Highly selective M1 receptor agonist derived from StaR® and SBDD

Strategic
Investment

Financials

M1

Partnered with:

Overview of the HTL0018318 muscarinic M1 agonist

 Cognitive benefits of M1 agonismsupported by Lilly’s clinical studies ofxanomeline1

 HTL0018318 is a potent muscarinic M1
agonist with negligible M2/M3 agonism
 StaR® & SBDD “designed out” unwanted
selectivity over the M2 & M3 receptors

HTL0018318
M1% activation

 Xanomeline’s development stopped due
to unacceptable CV and GI side effects
linked to stimulation of M2 & M3

Xanomeline1
Cognition
M GI side-effects

M2 CV side-effects
3

M4-11 -10 -9 -8 -7 -6 -5

Log [Xanomeline] (M)BehaviouralM1

Cognition

HTL0018318 is aselective M1 receptor
agonist for cognition
with negligible agonist
activity at M2 or M3
receptors

Receptor subtype selectivity is crucial. HTL0018318 has a differentiated mechanism of action with thepotential to optimise symptomatic benefits in AD patients
Source: Internal analysis
1 Bodick et. al. “Effects of Xanomeline, a Selective Muscarinic Receptor Agonist, on Cognitive Function and Behavioural Symptoms in Alzheimer’s Disease” Arch Neurol. 1997;54@465-473

1010GPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

AZD4635 has emerged as a potential next-generation I/O therapy
First A2a R antagonist structurally derived from StaR® and SBDD
Checkpoint inhibitors are a key cancer treatment

PD-L1

PD-1

CTLA-4AZD4635avelumab (2017)

A2a R antagonistatezolizumab (2016)

nivolumab (2014)

pembrolizumab (2014)

ipilimumab (2011)

Financials

A2aNext-gen I/O therapies to enhance treatment

durvalumab (2017)

Checkpoint inhibitors are highly effective against
certain types of tumors (e.g. lung, skin, and renal)
11
11Partnered with:

Strategic
Investment

MONOTHERAPYAZD4635

AZD4635

A2a R antagonist

A2a R antagonist

durvalumab

MEDI9447

Anti-PD-L1

Anti-CD73

COMBO THERAPYCOMBO THERAPY

Next-gen I/O may enhance efficacy of approved
checkpoint inhibitors across more tumor types

GPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

AZD4635 has emerged as a potential next-generation I/O therapy
First A2a R antagonist structurally derived from StaR® and SBDDAZD4635 exhibits dose dependent tumor growth inhibition, andrequires a working host immune system for effects

1 0 0 0

0

5 0 0

*
*
*

0

0

5

1 0

0

5

Days of Treatment

Intratumoral
CD8+ T cells
c e lls

8

MCA2052
I g G 1 IIsotype
s o t y p e C oControl
n tro lIgG1
A n ti- P D - L 1
Anti-PD-L1
A Z D 4 6 3 5 ( 5 0 m g / k g ) + a n t i- P D - L 1
AZD4635 (50mg/kg) + anti-PD-L1
A Z D 4 6 3 5 ( 2 5 m g / k g ) + a n t i- P D - L 1
AZD4635 (25 mg/kg) + anti-PD-L1
A Z D 4 6 3 5 ( 1 0 m g / k g ) + a n t i- P D - L 1
AZD4635 (10mg/kg) + anti-PD-L1

2 0 0 0*±S E

1 5 0 04

20

1 0 0 0

*
*

5 0 0

0
0

1 MC38 syngeneic colorectal cancer

12
12

2 MCA205 syngeneic fibrosarcoma cancer

1 5

DOSE DEPENDENT

G e o M e a n

o f to t a l liv e

6

1 0

Days of Treatment

INCREASED IMMUNE RESPONSE%CD8 of total live cells

Inhibition of A2a R signaling by AZD4635 in combination with antiPD-L1 can act to increase host immune surveillance andresponse

*
*
*

5 0 0

% C D 8AZD4635 alone and in combination with an anti-PD-L1 led to a
reduction in tumor growth in both adenosine high and adenosine
low syngeneic tumor models

33

1 0 0 0New supportive preclinical data presented at AACR 2018
A Z D 4 6 3 53)
Tumor Volume (mm(m m)
GeoMean±SEG e o M e a n ± S E

NEW Phase 1b/2 study with MEDI9447 (anti-CD73 antibody, open
and has started to enrol subjects)

V e h ic le

T u m o r V o lu m eVehicle0 mmg/kg,g / k g , B BID)ID )AZD4635( 5(50a n ti- P D - L 1 ( 1 0 m g /k g , B IW )anti-PD-L1 (10 mg/kg, BIW)A Z D 4 6 3 5 + a n ti- P D - L 1
anti-PD-L1 + AZD4635

1 5 0 03

Monotherapy and combination with durvalumab (anti-PD-L1)

MCA2052

V e h ic le

Tumor
Volume (mm)3)
T u m o r V o lu m e (m mGeoMean ± SE



LOW ADENOSINE TUMOR

MC381

VehicleA AZD4635
Z D 4 6 3 5 ( 5(500 m mg/kg,
g / k g , B IBID)
D )a nanti-PD-L1
t i - P D - L 1 ( 1(100 m mg/kg,
g / k g , B IBIW)
W )a nanti-PD-L1
t i- P D - L 1 + +A AZD4635
Z D 4 6 3 5

1 5 0 0

S E

Phase 1b dose expansion and signal seeking in patients ongoing
across multiple tumor types

±



A2a

Partnered with:

HIGH ADENOSINE TUMOR

G e o M e a n

Phase 1a maximum tolerated dose (MTD) achieved

3)
Tumor Volume (mm(m m)
GeoMean ± SEFinancials

New supportive preclinical data presented at AACR 2018

T u m o r V o lu m e

Excellent clinical progress to date

Strategic
Investment5

1 0

Days of Treatment

1 5

GPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

Strategic
Investment

Financials

Proprietary pipeline now led by M1 DLB opportunity in Japan
Focus on selected rare/orphan and specialty indications or markets
Proprietary pipeline
Product

Modality1

Indication

Originator

Phase

Q2 CY18

Q3 CY18

Phase 2a PoC clinical trial start

Q4 CY18

H1 CY19

H2 CY19

Proprietary GPCR Pipeline (Go-to-market/commercialize)
See slide 14

M1

SME

DLB (Japan)

Phase 1

mGlu5

SME

Neurological disorders

Preclinical

Phase 1 clinical trial start (healthy volunteers)

SSTR

SME

Endocrine / Neuroendocrine
disorders

Preclinical

Phase 1 clinical trial start (healthy volunteers)

CGRP

SME

Migraine and other severe
headaches

Preclinical

GLP-1

SME

Metabolic diseases

Preclinical

Phase 1 clinical trial start (healthy volunteers)

GLP-2

SME

Intestinal failure

Preclinical

Phase 1 clinical trial start (healthy volunteers)

Phase 1 clinical trial start (healthy volunteers)

Investment in StaR® technology driving Proprietary GPCR pipeline progress– average of 3 novel drug candidates into clinical development every year commencing CY2018
13
13

1 Note: SME = small molecule

GPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

Strategic
Investment

HTL0018318 for DLB in Japan
Great potential for M1 agonist treatment for DLB in Japan DLB is the second most common form of dementia andhighly relevant in Japan Real patient need in Japan – ageing population
 Recognition and diagnosis of DLB symptoms significantly
more advanced in JapanM1 DLB
Presynaptic cholinergic Neuron
AcCoA+
cholineChAT

ACh
M2 (–)

N (+)

agonist will show activity more rapidly and easily in M
DLB than in Alzheimer’s due greater cholinergic defectCholine+acetate1

 Potential to have a superior profile to donepezil as
HTL0018318 acts independently of presynaptic system

Acetylcholine (ACh)HTL0018318
Muscarinic
M1 receptor
agonist Potentially favourable environment – regulators in US/EU
adapting dementia guidelines to meet increased disease
understanding HTL0018318 represents a new treatment approach withpotential to show meaningful patient benefits

14
14

Financials


M1 R


M1 R


M R

Postsynaptic Neuron 1

GPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

Strategic
Investment

HTL0018318 for DLB in Japan
Summary of clinical program to dateFinancials

M1 DLB

Summary of clinical progress HTL0018318 derived from Heptares’ StaR® technology and SBDD HTL0018318 - same compound being investigated in AD trials with our partner Allergan•

Allergan paid $125 million upfront for a portfolio of muscarinic compounds, including HTL0018318

 In Phase 1a studies, HTL0018318 demonstrated to be safe and well tolerated, including in elderly people
 Ethnic bridging studies were completed by Heptares - safe and well tolerated in Japanese subjects
 HTL0018318 currently in a Phase 1b trial in patients with AD in Europe1
 Agreed with Allergan that Sosei has rights for approval and commercialization of HTL0018318 for DLB in
Japan
Clinical progress to date encouraging.
Advancing preparation to commence Phase 2 PoC study in DLB in Japan in Q3 CY18

1 EU study of HTL0018318 in AD https://www.clinicaltrials.gov/ct2/show/NCT03456349

15
15

GPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

Strategic
Investment

Financials

Strategic investment in saRNA technology
Exclusive option to move from 25.6% to 100% ownership at pre-determined economics
Pioneering RNA activation

Lead candidate CEBPA1 in Ph 1/2a for liver cancer

 saRNAs are a new therapeutic class and reversibly activate gene
expression

 CEBPA regulates multiple pathways in the liver and saRNA is aunique modality for targeting CEBPA Novel platform leveraging advances of siRNA therapeutics,
including clinically validated delivery platform MTL-CEBPA has preclinical efficacy across progression of liverdisease Unique opportunity to address undruggable targets
 Recent deal with Boehringer Ingelheim further supports
MiNA/saRNA’s potential

2

1

Loading of saRNA
into Ago protein

2saRNA-Agotargets genepromoter

3
3

1

16
16

4

1 CEBPA (CCAAT/Enhancer Binding Protein Alpha)4

 MTL-CEBPA is the first saRNA to reach the clinic – currently in clinical
trials in patients for liver cancer, an orphan indication

Tumour burden (cm3)Albumin change (%)

Bilirubin change (%)

saRNA-Agoactivates genetranscription
Long lasting
protein upregulation

Control

Scramble
saRNA

CEBPA
saRNA

Control

Scramble
saRNA

CEBPA
saRNA

Control

Scramble
saRNA

CEBPA
saRNA

Business
Model

GPCRs/StaR®

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

Strategic
Investment

Financials

Balance sheet strengthened to scale and progress the business
Allergan upfront milestone in FY2016 drives P&L variance
Revenue (ex Allergan upfront)

Summary financials (reported)(JPY m)1

FY2016FY2017

Revenue

18,9012

6,955

Cash Opex

5,496

7,790

Cash & cash equivalents

13,89928,281

Interest-bearing debt

6,900

9,173

JPY (m)Milestones

Royalties

Other
6,955

5,357

2,561

2,918

3,840

1,880
FY2016FY2017

USD (m)(USD m)

FY2016FY2017

Revenue

174.42

62.8

Cash Opex

50.7

70.4

49.4

Cash & cash equivalents

123.9

266.1

26.9

Interest-bearing debt

61.5

85.9

17.3

Milestones

FY2016

Royalties

Other
62.8
23.1
34.7
FY2017

Successful ~$200m raise in November 2017 via a Global Offering of shares to international investors.
Current cash balance of ~$260m provides runway of ~2 years based on organic business plan
17
17

1 Reporting currency in JPY

2 Includes USD 125m upfront payment from AllerganGPCRs/StaR®

Business
Model

Partnered
Proprietary
GPCR Pipeline GPCR Pipeline

Strategic
Investment

Financials

Substantial economic returns secured from lead compounds
Provides potential source of non-dilutive finance for proprietary pipeline
Summary of potential economic returns from out-licensing / collaboration projects
Partner

Program /Indication

Muscarinic
Receptor
program

A2a
Receptor
program

Up to 10targets
TOTAL

Upfront
received(US$m)

125

10

Nil

135

Total
Development
Milestones (US$m)

665

Total Sales
Milestones(US$m)

2,575

500

~189
per target

Total UF +Milestones(US$m)

3,365

510

N.D.

Milestones
Received(US$m)

Additional Details

15

Tiered,doubledigit

22

Tiered,doubledigit

Tiered(singledigit)

1,890

5,765

Royalty(US$m)



Exclusive global rights
Allergan committed $50m to a joint R&D program
through Ph 2a

Exclusive global rights to AZD4635
Collaboration to discover further A2A receptor blocking
compounds for development

Discovery of potential novel GPCR agents selected by
Pfizer (up to 10 targets)
Pfizer will be responsible for developing andcommercializing any agents discovered

37$5bn plus in potential development, regulatory and commercial milestones to come, in addition to royalties on sales

18
18

Global operations and aspirations – aiming to build Japan’s first global biotech champion
 World-leader in GPCR-focused drug design based on unique IP protected StaR®1 GPCR technology &enabled SBDD2 platform Partnered clinical-stage pipeline in neurology, immuno-oncology, CNS & other diseases, with $5bn plus in
potential economics
 Proprietary pipeline led by dementia with Lewy bodies (DLB) Phase 2 program in Japan, plus multiple
novel candidates in development
 Strategic investment in saRNA therapeutics with lead candidate in Phase 1/2a for liver cancer, an orphan
indication
 Robust royalties from legacy respiratory products provide source non-dilutive cash flows
 Strong cash position of ~$260m to drive global growth strategy
Thank you!
19
19

1 Stabilized receptor technology
2 Structure-based drug designLocations
SOSEI GROUPHEPTARES THERAPEUTICSPMO Hanzomon 11F
2-1 Kojimachi, Chiyoda-ku
Tokyo 102-0083 Japan

BioPark, Broadwater Road
Welwyn Garden City
Hertfordshire AL7 3AX United Kingdom
Grabenstrasse 11a,
CH-8952 Schlieren Zürich,
Switzerland

www.sosei.com

20

www.heptares.com

CEBPA - C Enhancing beta Protein Alpha