NON – CONFIDENTIAL

World leading drug discovery
targeting GPCRs
Corporate Presentation
2021 | © Sosei Group Corporation

Disclaimer
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© Sosei Group Corporation. Sosei Heptares is the corporate brand and trademark of Sosei Group Corporation. Sosei, Heptares, the logo and StaR® are trademarks of Sosei Group companies.

2

World leading drug discovery targeting GPCRs
World leader in
GPCR drug discovery
and early development

EVOLVING WITH A SPECIALISTTHERAPEUTIC FOCUS

Proprietary GPCR-targeted
StaR® technology and SBDD
platform capabilities

Advancing a broad and deep
pipeline of over 40 partneredand in-house programs acrossmultiple therapeutic areas:
Neurology
Immunology
Gastroenterology
Other

Japan-anchored biotech, withstate-of-the-art R&D centre in
Cambridge, UK
Listed on Tokyo Stock Exchange(4565-JP)

14%
34%
25%

200+

EMPLOYEESWORLDWIDE340+

STRUCTURESSOLVED500+

GLOBALPATENTS

15+

WORLD-LEADINGPARTNERSPARTNER REV.
RECEIVED TO DATE1

1 Includes upfront and milestone payments, royalties and R&D funding received from active, inactive and completed partnerships from 2005 to 2020.

3$700M+

27%

We can unlock the potential of GPCRs with our StaR® technology
GPCRs are well-known targets withsignificant untapped opportunity

~400

GPCR
PROTEINS

StaR® enables us to unlock the potential of GPCRs via advanced
understanding of their structure and atomic/molecular interactions
Unstable
native GPCR

Stabilized
StaR® protein
Enables mAb discovery

75%

SBDD
Novel drugcandidate
SMEs and Peptides

4

Sources: “Unexplored opportunities in the druggable human genome”, Nature Reviews, 2016 ;“Trends in GPCR in Drug Discovery – new agents, targets and indications”, Nature Reviews,
2017; Management analyses

Receptors for which a structure has beenreleased in Protein Data Bank (public domain)

Solved 340+ molecular structuresfrom 40+ different receptors / 70+ StaRs
Receptors for which Sosei Heptares
has developed a StaR®

Core capabilities in drug discovery and early development, with alate-stage development team in Japan focused on in-licensing
DRUG DISCOVERY/EARLY DEVELOPMENT DRIVEN BY STAR® / SBDD ENGINE
PRE-DISCOVERYDISCOVERYPRECLINICAL

PH 1a

PH 1b

StaR® Technology

SBDD

DMPK

SAD

Dosing assessment

Structure

Chemistry

Toxicology

MAD

Hit ID

Pharmacology

Translation

Experimental
Medicine

Proof of
MechanismTarget ValidationPrograms advanced through to certain value inflection points
before partnering / seeded into co-owned investment vehicles

5

LATE STAGE DEVELOPMENT

PH 2/3

APPROVAL•

Strategic tactical development
team sources novel global
treatments for Japanese patients•

Development plans target
approvals and domestic launch by2025 timeframe
PMDA

PMDA

Clinical Efficacy

PharmacovigilanceEstablished track record of attracting world-leading partners
Active Partnerships~$700
millionUpfront and milestone payments,
royalties and R&D funding
received from partners to date1

Active Spin-Out Asset Centric Vehicles~$6billionTotal potential deal value ofactive partnerships2

1 Encompasses payments received from active, inactive and completed partnerships from 2005 to 2020. 2 Includes potential option fees, upfront, development, regulatory and commercial milestone payments

and committed R&D funding. Excludes potential royalty payments.

6

Ten drug candidates generated from our SBDD platform have beensuccessfully advanced into clinical trials
Generated

Acquisitionof Heptares
by SoseiTODAY*

25

LEAD OPpreclinicalcandidates

6 programs
PRECLINICAL

Produced

10
clinicalcandidates

9 candidates
CLINICAL
9 candidates

One of the most productive drug discovery teams in the world over the past 10 years*5 programs (1 x Phase 1, 2 x Preclinical, 2 x Discovery) have been prioritised for academic or industrial partnerships. More information here: https://soseiheptares.com/other-programs-for-partnering

7

We are continuing to make progress in collaborative drug discovery,
having added three new major partnerships over the past year…
Partner

Active Partnered Program

Therapeutic Area

UF / Near Term Payments

Potential deal value1

2020 Collaboration and Licensing
Agreement for GPR35 agonist

Gastrointestinal,
immunology$44m$480m+

2020 Collaboration and Licensing
Agreement for CGRP antagonist

Neurology$10m$380m+

2020 Discovery Collaboration andOption to License2

Inflammatory andAutoimmune$32m$400m+

2019 Multi-target Collaboration

Multiple; Initial focus on
Gastrointestinal$26m$1.2bn+2019 Multi-target Collaboration

Multiple$26m$1.0bn+2015 Multi-target Collaboration

MultipleNil$1.8bn+2015 Collaboration and Licensing
Agreement for A2a antagonist3

Immuno-oncology$10m$500m+$148m$5.9bn+TOTAL
1 Potential option fees, development, regulatory and commercial milestone payments, plus royalties on global commercial sales;
2 AbbVie has the option to expand the collaboration by an additional three targets

8

3 AstraZenenca have removed the A2a program from their clinical pipeline as at Q3 2021

…and a deep pipeline of exciting in-house programs, plus newtechnology collaborations, that will form the partnerships of the future
Pre-Disc. / Discovery

Preclinical studies

Multi-target

Phase 1
GPR35 ag.

Multiple

IBD

T2DM/Obesity

Marketed

A2a ant. combo(s)**Ultibro® Breezhaler®

mCRPC

COPD

Multi-target

CCR6 ant.

Seebri® Breezhaler®

Multi-target

MC4 ant.

Enerzair® Breezhaler®

Single target

CGRP ant.

Oravi®

Multiple

Outlicensed

GLP-1 ag.

Phase 2IBD

GI and other

Anorexia

Inflammatory

Neurology

COPD

AsthmaMouth candidiasis

CXCR4 mAb

Co-dev /Profitshare

Co-owned
companies

TPD

Ion channel

PAR2 peptide

AI-driven

OX1/OX2 ag.

mGlu5 NAM

Narcolepsy

Substance Use

SARS-CoV-2 MPro

GPR52 ag.

H4 ant.

M1M4 ag.

M4 ag. HTL’878

EP4 ag.

EP4 ant.

PAR2 mAb

Targeting partnershipby end-2021

M1 ag. HTL’936/’318

Coronaviruses

In-house /Not yetpartnered*

Immuno-oncology

IBD

Neurology

Immuno-oncology

Atopic Dermatitis

Atopic Dermatitis

Neurology

Neurology

Neurology

10+ other programs
Note: Seebri®, Ultibro®, Enerzair® and Breezhaler® are registered trademarks of Novartis AG. * The in-house pipeline displayed above includes fully funded programs only and excludes back-up programs and similar indication programs for one target. For
9 example– A2a ant, SSTR5 ag, GLP-1 ant, GLP-2 ant, M1 and M4 backup programs (list not exhaustive). ** AstraZenenca have removed the A2a program from their clinical pipeline as at Q3 2021

Partnered Program
In-house ProgramNext wave of COVID-19 therapies – SARS-CoV-2 protease inhibitors

Overview

PAXLOVID™ (PF-07321332; ritonavir)– small molecule oral antiviraltreatment; twice a day dosing at firstsign of infection / exposure

S-217622 – small molecule oral
antiviral treatment; once a day
dosing.

SH-879 – small molecule oral antiviraltreatment; once or twice daily dosing
immediately after a positive test resultand for up to 2 weeks after

Phase

Phase 2/3 trial initiated in July 2021
for PF-07321332/ritonavir combo

Japanese Phase 1 trial initiated inJuly 2021

Potential clinical candidate identified
suitable for further development• Animal studies showed ability todecrease the viral load quickly andsignificantly• No safety concerns reported so far

Key data findings• Good tolerability, no safety
findings up to 500mg dose 2x daily
with ritonavir/10 days in HVs• Interim analysis found risk of
hospitalization or death reducedby 89% compared to placebo in
non-hospitalized high-risk adults
with COVID-19• Requirement for ritonavir
combination boost exposure• Comparable antiviral activity
to Pfizer’s PF-07321332 against
SARS-CoV-2 in cell based assays• Low in vitro clearance, superior invivo clearance and high plasma
exposure from oral dosing• Does not co-dosing with ritonavirfor PK boosting in human clinical
trials, unlike Pfizer’s PAXLOVID™

Advanced discussions ongoing with a leading global charitable foundation – targeting rapid development of a single
agent without the need for co-dosing with other anti-viral therapies
10

Source: Company announcements; Company websites

Muscarinic portfolio, led by HTL’878, represents a ready-made HTL’878
neuroscience pipeline of multiple potential blockbuster programs
Program

Indication

HTL’878

Schizophrenia

Phase 2 readyortho
orthoagonist
agonistNot disclosed

Schizophrenia

Completion of
Phase 1 SAD

M1R/M4R dual
ortho agonist

Not disclosed

Schizophrenia &Alzheimer’s
cognition & psychosis

IND readyHTL’318

Alzheimer’s
Dementia Lewy Bodies

Regulatory
consultation

HTL’936

Alzheimer’s
Dementia Lewy Bodies

Clinical PK

Not disclosed

Alzheimer’s
Dementia Lewy Bodies

IND readyM4R
ortho agonist

M1R
ortho agonist
pathfinders
M1R
ortho agonist

Discovery

Preclinical

Phase 1

Phase 2

Next Milestone
12-18 months

CompoundNegotiations progressing well with multiple potential global development/co-development partners.
Current intention remains to partner all programs in order to aggressively accelerate their development
Key: Full box = completed phase. Striped box = next milestone11

HTL’878 is a 4th-generation candidate aiming to be a highly
effective and safer treatment for Schizophrenia
Efficacy

SafetyPositive
symptoms

Negative
symptom

Cognitive
impairment

Extrapyramidal
symptoms**

Weight gain

MoA

Typical medicine

Peak sales
exampleGeneration

Number of patients
20M*

Number of patients
11.5M*

Number of patients
16M*

-

-

Typicalantipsychotic

D2 AntHaldol(Historic data
unavailable)

1st

+++

-

-

++++

+

Atypical
antipsychotics

D2 Ant+5-HT Regulator

Zyprexa
Risperdal
LatudaZyprexa$5,000M+(2010)

2nd

+++

+

+

++

++++

D2 partial Ag+
5-HT Regulator

Abilify
REXULTI
VraylarAbilify$6,100M+(2013)

3rd

+++

+

+

+

+

M4 Agonist***KarXT
CVL-231
HTL’878

-

4th

+++

++

++

-

-

After regaining the program in early 2021, we rapidly invested behind HTL’878

12

HTL’878*As 1 patient can have several symptoms, number of patients in 3 symptoms is overlapping**Drug-induced movement disorders including involuntary or uncontrollable movements. tremors. muscle contractions. It is said to be related with D2 receptor occupancy balance.
***Expected efficacy and expected safety derived from ongoing clinical trials of KarXT and CVL-231.
Source：P T. 2014 Sep; 39(9): 638–645, J Clin Psychiatry. 2010;71(3):280–286, Schizophr Bull. 2010 Jan; 36(1): 36–42 and EvaluatePharma

HTL’878
HTL’878 is differentiated and is the only highly selective
orthosteric agonist of the muscarinic M4 receptor in development
Direct agonism of
M4R is a clinicallyvalidated target forpsychoses

HTL’878 is anorthosteric partial
direct M4R agonist
with a potentially
improved sideeffect profile• Direct agonism of the muscarinic M4 mechanism is a clinically validated target for the treatment of psychoses(Xanomeline, KarXT), underpinned by strong non-clinical science from around the world• HTL’878 has been shown to act via selective direct agonism of the M4R in non-clinical species and also in humans• HTL’878 is an orthosteric partial direct M4R agonist with a potentially improved side effect profile in comparison withthe front-runner (KarXT) and likely CVL-231• HTL’878 has much better selectivity and a potentially improved side-effect profile than KarXT• CVL-231 is a Positive Allosteric Modulator ( PAM )which therefore requires ACh tone in the CNS making it difficult
to achieve a margin over CV side effects• Efficacy of an orthosteric agonist does not depend on cholinergic tone, unlike a PAM – we expect also stronger efficacy
in Dementia Related Psychosis than a PAM which is unlikely to be effective

Of the fourth-generation treatments in development, HTL’878 stands out as a potentially superior approach13

Looking forward

14Strategic growth plan driving corporate value expansion
OBJECTIVE

Capital raisecompleted to pursue
revenue focuseddeals in 2021/2022

STRATEGIC GROWTH PLAN

Seek out revenuegenerating opportunities

Invest / collaborate innovel technologies

OBJECTIVE

Take steps to expand
beyond core GPCR
specialty


OBJECTIVE

Add new technology
capabilities to our
SBDD platform

OBJECTIVE

Expand drug target
classes beyond GPCRs

In-license late-stage
programs for Japan

Bring international
medicines toJapanese patients inareas of unmet need

Seeking to add new revenues, access new technologies, and expand and future-proof our capabilities

15

Three big challenges in drug discovery and development
KEY OPPORTUNITY

Choosing
the right target

Discoveringa therapeutic agent

Conducting
the right patient studies•

Will modulating the target
affect disease?

•

Identifying a modulator withthe appropriate profile•

Demonstrating the value ofthe agent in treating disease•

Can a good modulator of thetarget be found?

•

Differentiating fromcompetitors (if any)•

Utilizing biomarkers to
support patient stratification

Our greatest opportunity is to leverage technology to choose the right drug targets
that will become the transformational therapies of the future

16

Aim

How

Why

To support the identification andvalidation of new drug GPCR targets
across our core therapeutic areas (GI,immunology, immuno-oncology andneuroscience)
By leveraging top-end external company
omics platforms/databases andvalidation capabilities
To add exciting novel GPCR targets toour pipeline which have evidence of adirect involvement in a disease /mechanism process to fuel partnering
activity and higher value creation

AI / Machine Learning

We have created the New target ID and validation (TIV) frameworkto accelerate our quest to choose the right targets
Bioinformatics

Proteomics

SBDD
platform

Transcriptomics

Small Molecule
Discovery

Genomics

Clinical Trials

Clinical/Patient Data

Continuously expanding our know-how and SBDD platform to maintain our leadership position in GPCR drug discovery

17

New TIV Framework - mid-term plan to pursue investments andexternal collaborations to hunt novel first-in-class drug targets
2021

2022

2023

INTERNAL THERAPEUTIC AREA INITIATIVESNEW EXTERNAL COLLABORATIONS / ALLIANCES

PRE-DISCOVERY

Therapeutic
Area

PE

TargetID

TargetValidation

MAXIMIZE EXISTING COLLABORATIONS



2024

• To support our Therapeutic Areas of Interest(GI/Immunology/Neuroscience)

TV

BMS

HID

DISCOVERY
H2L

Target Validation

Systems
Biology

Investing in the next wave of future targets
mAb PLATFORM BUILD• Identify strategic partner to maximise
platform capability

Over the next 6-12 months you will see us expand our external technology collaborations and alliances
Note: PE = Protein Engineering; BMS = Biomolecular Structure; TV = Target Validation; HID = Hit Identification; H2L = Hit-to-Lead; LO = Lead Optimization

18

LOPriority objectives for FY2021/FY2022

Progress organic
growth plan

19

Execute strategic
growth plan•

Extend technology / platform
leadership•

Invest / collaborate in novel
technologies•

Generate high quality novel
candidates•

Diligence potential strategic
M&A opportunities•

Advance discovery anddevelopment pipeline•

Diligence potential
opportunities for Japan•

Execute high value
partnerships•

Expand drug target classes
beyond GPCRs

Commitment to sustainable
development goals•

Promote sustainable ESG
practices and policies acrossglobal business•

Advance Mpro inhibitor
program and seek
collaboration to further
develop candidates as oral
treatments for humancoronaviruses

Appendix

20

Progression of Partnered Pipeline
CompoundTarget / Mechanism of Action
Modality
Traditional Out-licensing Collaborations
Seebri® Breezhaler® LAMA
SME
Ultibro® Breezhaler® LAMA+LABA
SME
Enerzair® Breezhaler® LAMA+LABA+ICSSME
ORAVI®
Antifungal agent miconazole
SME
Imaradenant**
Adenosine A2a ant. combo
SME
PF-07081532
GLP-1 agonist
SME
PF-07054894
CCR6 antagonist
SME
PF-07258669
MC4 antagonist
SME
BHV3100
CGRP antagonist
SME
Not disclosed
GPR35 agonist
SME
Not disclosed
Multi target
SME
Not disclosed
Multi target
SME/LMENot disclosed
Multi target
SME/LMENot disclosed
Single target
SME
Co-development / Profit-share Collaborations
KY1051CXCR4 mAb
mAb
Not disclosed
PAR-2
PeptideNot disclosed
Targeted Protein Degradation
SME
Not disclosed
AI-Augmented Drug Discovery
SME
Not disclosed
Ion Channel Drug Discovery
SME
Not disclosed
Multi target AI-powered
SME
Co-owned investments
TMP301mGlu5 NAM
SME
Not disclosed
OX1/OX2 agonist(oral and intranasal) SME

21

Indication

FY2020 stage
FY2021-Now progress
Partner

Disc.

PCC

Ph1

COPD
COPD
AsthmaOropharyngeal candidiasis
mCRPC
T2DM / Obesity
Inflammatory bowel disease
Anorexia
Neurology diseases
Inflammatory bowel disease
Multiple indications
Multiple indications
Gastrointestinal and other
Inflammatory diseases
Immuno-oncology
Inflammatory diseases
Gastrointestinal disorders
Neurology diseases
Neurology diseases
Immune diseases
Substance use disorders
Narcolepsy

Note: SME = small molecule. LME = large molecule. Seebri®, Ultibro®, Enerzair® and Breezhaler® are registered trademarks of Novartis AG. ** ** AstraZenenca have removed the A2a program from their clinical pipeline as at Q3 2021

Ph2

Ph3

App

Mkt

Progression of In-house Pipeline
CompoundTarget / Mechanism of Action Modality
Indication
In-house Programs (Not yet partnered)
HTL’878
Muscarinic M4 agonist
SME
Neurology diseases
1
HTL’318
Muscarinic M1 agonist
SME
Neurology diseases
HTL’936
Muscarinic M1 agonist
SME
Neurology diseases
Not disclosed
Muscarinic M1 agonist (B/U)
SME
Neurology diseases
Not disclosed
Muscarinic M4 agonist (B/U)
SME
Neurology diseases
Not disclosed
Muscarinic M1/M4 agonist
SME
Neurology diseases
Not disclosed
H4 antagonist
SME
Atopic Dermatitis
Not disclosed
EP4 antagonist
SME
Immuno-oncology
Not disclosed
GPR52 agonist
SME
Neurology diseases
Not disclosed
PAR-2 mAb
mAb
Atopic Dermatitis
SH-879SARS CoV-2 Mpro
SME
Coronaviruses
Not disclosed
EP4 agonist
SME
Inflammatory bowel disease
Multiple programs
Not disclosed
SME/LME
Neurology diseases
Multiple programs
Not disclosed
SME/LMEGI and Inflammatory diseases
Multiple programs
Not disclosed
SME/LME
Immunology diseases
In-house Programs (No longer internally funded. Targeting academic / industrial partnership)
HTL’310
SSTR5 agonist
PeptideHypoglycaemic disorders
HTL’097
GLP-1 antagonist
PeptideHypoglycaemic disorders
HTL’023
Dual GLP-2/GLP-1 agonist
PeptideIntestinal failure / NASH
Not disclosed

Apelin agonist

PeptidePulmonary Arterial Hypertension

HTL’641

Dual orexin antagonist

SME

Insomnia and sleep disorders

Note: SME = small molecule. LME = large molecule. 1 Voluntarily suspended

22

FY2020 stage
FY2021-Now progress
Originator

Dis

PCC

Ph1

Ph2

Ph3

App

Mkt.

IR@soseiheptares.com

SOSEI HEPTARESPMO Hanzomon 11F

Steinmetz Building

North West House

2-1 Kojimachi, Chiyoda-ku

Granta Park, Cambridge

119 Marylebone RoadTokyo 102-0083

CB21 6DG

London NW1 5PU

Japan

United Kingdom

United Kingdom

www.soseiheptares.com@soseiheptaresco@soseiheptaresco@soseiheptaresco