r&d pipeline update – translating cutting -edge science into new … · 2019-09-12 ·...
TRANSCRIPT
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Malcolm Weir – EVP, Chief R&D Officer
R&D Pipeline Update – Translating Cutting-edge Science into New Drug Candidates
NON-CONFIDENTIAL
12 September 2019 | R&D Investor Day
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Malcolm Weir – EVP, Chief R&D OfficerAbout Me
BRITISH HERITAGE;UK-BASED
IMPERIAL COLLEGE
BSc.,PhD.VISITING PROF
MALCOLM CAMPBELL MEMORIAL PRIZE
2015
EVP, CHIEF R&D OFFICER, 4 YEARS
CO-FOUNDER AND CEO,8 YEARS
CEO & CSO,6 YEARS
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Introduction
Chief R&D Officer
Platform Technology Drug Discovery
Protein Engineering
Biomolecular Structure
Biophysics
Comp.Chemistry
Medicinal Chemistry
Molecular Pharmacology
Translational Sciences
Clinical Drug Development
Clinical Development
Preclinical Development
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We are the world leader in GPCR drug discovery and development
WE ARE RECOGNIZED GLOBALLY FOR WORLD-CLASS, PIONEERING SCIENCE
Solved
260+Molecular structures
From
25+Different GPCRs
Solved
>30%Structures of GPCR targets
OUR TECHNOLOGY HAS ATTRACTED WORLD LEADING PHARMA AND
BIOTECHS AS KEY PARTNERS
COLLABORATIONS WITH LEADING ACADEMIC GROUPS KEEP US AT THE
CUTTING EDGE OF SCIENTIFIC RESEARCHOUR CO-FOUNDER
RICHARD HENDERSON WAS AWARDED THE
NOBEL PRIZE IN CHEMISTRY
FORMED 2 SPIN-OUT COMPANIES
4PRODUCTS
ON MARKETGLOBALLY
29R&D PROGRAMSDISCLOSED WITH
BROAD AND DEEP PIPELINE BEHIND
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In 2015, our pipeline was early stage and predominantly unpartneredDiscovery Preclinical Phase 1 Phase 2 Phase 3 Marketed
M1M4
M1M4
A2A
CGRP
GLP-1 ant
OX-1 ant
Ultibro®
Seebri®
Oravi®Ph 1a
Undisclosed
APP13007*
APP13002*
* Originally designed and developed at Activus Pharma (former wholly owned subsidiary of Sosei Group Corporation). Activus was divested to Formosa Pharmaceuticals in August 2017. Sosei Heptares remains eligible to receive undisclosed milestone payments based on the progression of Activus’ pipeline at Formosa
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Today, we have a broad and deep partnered and in-house portfolioDiscovery Preclinical Phase 1 Phase 2 Phase 3 Marketed
M1M1M4
Undisc.
Undisc.
CXCR4
GLP-1 ant
OX-2 ag Ultibro®
Seebri®
Oravi®
QVM149A2APh 1b
M4
A2A
mGlu5
SSTR
M1DLB1
CGRP
GLP-2
OX-2 ag
Undisc.
OX-1 ant
Apelin
GPR35
H4
PAR2
Mul
tiple
und
isclo
sed
In-h
ouse
pro
gram
s
Norlevo®
1 Phase 2 trial of HTL0018318 for DLB in Japan remains under voluntary suspension. The Group plans to resubmit a new clinical trial notification for HTL0018318 (or another novel M1 agonist) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in the future
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Our core strengths differentiate us from our peers
NEW GPCR TARGET STRUCTURE AND FUNCTION
HIGH QUALITY COMPOUNDS
GLOBAL DEVELOPMENT CAPABILITY
FLEXIBLE PARTNERING STRATEGY
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Committed to remaining at the cutting edge of technology
Platform Technology (StaR® - Structure)
Drug Discovery
(SBDD)Development
Business Development (New/Existing Partners)
Collaboration with the University of Cambridge to roll out artificial intelligence / machine learning across the platform
Investment in state-of-the-art Cryo-electron microscopy and DNA encoded libraries
New multi-target research, development and commercialization partnership with Genentech
Two candidates nominated under the Pfizer multi-target collaboration to advance into clinical development
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Generating new waves of high quality novel compounds
Platform Technology (StaR® - Structure)
Drug Discovery
(SBDD)Development
Business Development (New/Existing Partners)
15 programs ongoing in the discovery phase and 6 programs advancing in preclinical development
Shifting portfolio shape to align with translational capabilities in place for CNS and Immunology indications
Creation of two asset-centric companies, Orexia and Inexia, to develop the treatment of neurological diseases
New strategic multi-target research, development and commercialization partnership with Takeda
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Successfully advancing novel molecules into the clinic
Platform Technology (StaR® - Structure)
Drug Discovery
(SBDD)Development
Business Development (New/Existing Partners)
8 programs currently in clinical trials, both with partners and in-house (pre-partnered)
In-house (pre-partnered) programs mGlu5 and SSTR5 entered into Phase 1 development
Partnered programs A2a, M1 and M4 are all progressing with confidence, with A2a in particular advancing to Phase 2
development for multiple solid tumors
Valid Marketing Authorization Application submitted to the EMA for partnered program QVM149
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Executing strategic collaborations with new innovative partners
Platform Technology (StaR® - Structure)
Drug Discovery
(SBDD)Development
Business Development (New/Existing Partners)
$26m upfront and near-term payments and $1bn+ in potential milestone payments from new Genentech collaboration
$26m upfront and near-term payments, research funding, and $1.2bn+ in progress related milestones
from new Takeda partnership
Medicxi to invest up to €40m in new collaboration, creating two asset-centric companies
$6m received from Pfizer, $15m received from AstraZeneca and $2.5m received from Novartis in progress related milestones
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We are developing new therapies for areas of high unmet medical need
Sources: World Health Organization, EvaluatePharma, Management Estimates. Notes: Market sizes represent global sales of products targeted at any aspect of the market. Sosei Heptares may choose to only target a segment of the specific market. 1 Represents market size for Cushing’s syndrome, rather than Cushing’s disease
~300Kaffected globally
$1.1bn20241
Cushing’s
~50Maffected globally
$7.4bn2024
Dementia
~1.6Maffected in US (mod-sevuncontrolled)
$6.6bn2024
Atopic Dermatitis
~50Kaffected globally
$5.7bn2024
PAH
~450K affected globally
$1.2bn2024
ALS
~42Maffected globally
$220bn2024
Cancer
~3.1Maffected globally
$19.1bn2024
IBD
• SSTR agonist• M1 agonist• M4 agonist• M1/M4 agonist
• H4 antagonist• PAR2 mAb • Apelin agonist • mGlu5 NAM • A2a antagonist
• CXCR4 mAb • GPR35 agonist
~1.1Baffected globally
$8.3bn2024
Migraine
• CGRP antagonist
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Dementia affects 50 million people globally1
Sources: 1 Alzheimer’s Disease International; 2 Alzheimer’s Research UK, Dementia Statistics Hub; 3 Coherent Market Insights, Dementia Drugs Market – Global Forecast to 2026 (2018); 4 OECD (via Financial Times)
FIGHTING DEMENTIA FOR A BETTER FUTURE
$817bnGlobal cost of
Dementia2
60%Dementia cases are Alzheimer’s
Disease3
People with Dementia per 1,000 population4
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Giving Alzheimer’s patients hope with symptomatic treatment
Sources: Cummings, J. et al “Alzheimer’s disease drug development pipeline: 2018” Alzheimer’s & Dementia: Translational Research & Clinical Interventions (2018) 4: 195-214 (based on Clinicaltrials.gov information as of 30-Jan-18); Cumming, J. et al “Drug development in Alzheimer’s disease: the path to 2025” Alzheimer’s Research & Therapy (2016) 8:39
Ph 3Ph 2Ph 1 2018Alzheimer’s
Drug Dev.Pipeline
HTL18318
6
11
10
11
26
7
9 26 5
DISEASE-MODIFYING THERAPIES (DMT) SYMPTOMATIC TREATMENTS
Disease-modifying immunotherapy Disease-modifying small molecule Symptom-reducing small molecule # Number of candidate agents being tested in each phase of development
• Primary aim to modify the course of disease and slow progression or delay its onset
• Memantine and combination Memantine-donepezil – the last approved novel treatments for Alzheimer’s (Allergan)
• No approved candidate agents –all Ph 3 amyloid DMTs have failed
• Recent Ph 3 drug failures have targeted amyloid-beta (Abeta)
• aducanumab (Biogen/Eisai)
• crenezumab (Roche/AC Immune)
• solanezumab (Eli Lilly)
• Primary aim to temporarily improve memory and attention symptoms
• 4 cholinesterase inhibitors and memantine have received marketing approval at a global level
• Allergan partnership puts us in the best position to offer significant hope to patients in near future
• Heavily weighted focus on DMTs has left patients without new treatments
• Additionally, 3 g-secretase inhibitors and 4 BACE inhibitors have not arrested cognitive decline
• Sosei Heptares and Allergancommitted to selective M1 and/or M4 agonism to offer a FIC symptomatic treatment with a novel post-synaptic MoA
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Potential first-in-class therapy with a novel post-synaptic MoA
1 Clinical Trial Posting: https://clinicaltrials.gov/ct2/show/NCT03244228
PARTNERED WITH
Muscarinic M1 Muscarinic M4
• Work continues on the portfolio of M1 agonists to advance certain compounds through development
• Multiple compounds with the potential to be new candidates have been discovered
• HTL18318 investigation progressing – update late 2019
• HTL16878 continues to progress towards IND patient studies
• Current Phase 1 studyprogressing well1
• Backup compounds advancing in parallel
Dual M1 / M4
First-in-class, selective small molecule muscarinic M1receptor agonist as a potential new symptomatic treatment of cognition in neurodegenerative disorders
Designed to be selective for M1 receptors and to avoid unwanted side effects and off-target binding seen with other poor muscarinic agonists
Works through the cholinergic pathway, however bypasses presynaptic activity, stimulating the M1 receptor directly and does not rely on Ach levels in the brain
High selectivity offers the possibility for an improved safety profile over previous non-selective muscarinic receptor agonists
First-in-class, selective and orally available small molecule muscarinic M4 receptor agonist designed to work through a different MoA than available antipsychotics
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Cancer was responsible for 9.6 million deaths in 20181
Sources: 1 World Health Organization; 2 EvaluatePharma; 3 Prasad, V., Mailankody, S. Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval. JAMA Intern Med. 177(11):1569–1575 (2017); 4 EvaluatePharma. I/O Checkpoint Inhibitors includes Keytruda, Opdivo, Tecentriq, Imfinzi and Bavencio
ATTACKING CANCER WITH NEXT-GEN
THERAPIES
$220bnGlobal market
in 20242
$648mCost to develop a cancer drug3
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
Global I/O Sales ($bn)4
$16.3bn
$35.6bn
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Targeting adenosinergic signaling in cancer immunotherapy
Source: Computational and Structural Biotechnology Journal 13 (2015) 265–272
Accumulation of extracellular adenosine within the microenvironment is a strategy exploited by tumors to
escape immune surveillance
Adenosine signalling through the high affinity A2aR on immune cells elicits a range of immunosuppressive effects
which can promote tumor growth and limit efficacy of immune checkpoint inhibitors
Blocking A2a receptor activation can reverse adenosine mediated immune suppression to markedly enhance anti-tumor immunity. A2a antagonists are the next generation
checkpoint blockade for cancer immunotherapy
1
2
3
Adenosine-A2aR signaling: the emergence of a novel immune checkpoint pathway
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AZD4635 is a highly potent and selective A2a antagonist
1 Clinical Trial Posting: https://clinicaltrials.gov/ct2/show/NCT027409852 Clinical Trial Posting: https://clinicaltrials.gov/ct2/show/NCT03381274
PARTNERED WITH
AZD4635A2aR antagonist
MONOTHERAPY
AZD4635
Anti-PD-L1
A2aR antagonist
durvalumab
AZD4635
oleclumabAnti-CD73
A2aR antagonist
AZD4635 enhances immune activation and increases CD8+ infiltration in combination with anti-PD-L1
Treatment with AZD4635 alone and in combination with an anti-PD-L1 Ab led to a reduction in tumor growth in both adenosine high and low syngeneic tumor models
AZD4635 enhances expression of genes associated with T-cell and antigen presenting cell functions
AZD4635 is currently in Ph1b/2 clinical trials as a single agent and in combination with durvalumab (anti-PD-L1 Ab)1 in patients with solid malignancies, and in combination with oleclumab (anti-CD73 Ab)2
Blockbuster potential as both a monotherapy and combination therapy, across multiple tumor types
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The average life expectancy for ALS patients is 2 to 5 years1
Source: 1 ALS Association
STRIVING TO IMPROVE SURVIVAL DURATION
AND QUALITY OF LIFE
Every
90minsSomeone is
diagnosed and someone perishes1
$2.0bnCost to develop a drug to slow/stop ALS progression1
Amyotrophic lateral sclerosis (ALS) is aPROGRESSIVE NEURODEGENERATIVE DISEASE that is 100% FATAL. There is NO CURE for ALS.
Progressive loss of muscle control
ALS gradually prohibits the ability to:• Speak• Swallow• Walk• Grasp objects• Move• Breathe
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mGlu5 NAM HTL14242 is a novel therapeutic target for ALS
1 Clinical Trial Posting: https://clinicaltrials.gov/ct2/show/NCT03785054
CURRENTLY WHOLLY-OWNED
HTL14242mGlu5 NAM
PHASE 1
Regulatory toxicology package complete
Investigators Brochure and IMPD complete
Ongoing preclinical work including further ALS related studies
Phase 1 clinical program initiated 1
• Double blind placebo controlled single ascending dose in healthy volunteers
• Encouraging initial PK
mGlu GPCRs are expressed throughout CNS where they modulate neurotransmission and have been shown to have potential in a variety of neurological indications
HTL14242 maintains motor function for longer and shows trend to increase survival dosed in model from disease onset
Strong preclinical evidence that mGlu5 NAM can benefit functional and survival as demonstrated in SOD1G93A
mouse model of ALS
Attractive landscape for an effective mGlu5 NAM therapeutic agent in ALS – current standard of care, Riluzole, prolongs life by ~3 months
ALS, Dystonia and Levodopa-induced Dyskinesia (PD-LID) represent promising therapeutic and competitive opportunities for this mechanism
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Significant potential in GPCR peptide therapeutics
Peptides
Teduglutide(GLP2)
Exenatide(GLP1)
Tesamorelin(GHRH)
Pramlintide(Amylin)
Icatibant(BK2)
HTS
Maraviroc(CCR5)
Suvorexant(OX 1/2)
Vorapaxar(PAR1)
Chemocentric
Rasmelteon(MT1)
Mirabegron(β3)
First-in-Class (FIC) GPCR Drugs 2005-2015
Almost half of the FIC GPCR drugs in this 10 year period are injectable peptides
Phenotypicscreening
Fingolimod(S1P1)
Vismodegib(SMO)
Chemical ModificationsBridges and
staples
D-Amino Acids
Fatty Acid and PEG
group additions
N- and alpha methylation
Applying Structure-based Drug Discovery (SBDD) to Peptides
Opportunity to broaden our use of SBDD to peptides
Developing modified peptide hormones which may be more tractable / faster to clinic than
small molecules
Peptide FIC by subcutaneous / long-acting injectable, with
potential to follow up with oral small molecules
Oral, topical peptides to target gastrointestinal disorders
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Current standard of care for Cushing’s Disease is inadequate
Sources: 1 EvaluatePharma; 2 Castinetti, F. et al. Cushing’s Disease. Orphanet J Rare Dis. 2012; 7:41.; 3 Melmed, S. et al. A Consensus Statement on acromegaly therapeutic outcomes. Nature Reviews Endocrinology 14, 552-561 (2018)
2018 2019 2020 2021 2022 2023 2024
Mifepristone Pasireotide Levoketoconazole Relacorilant
$418m
$1,064m
80%Endogenous
Cushing’s Syndrome cases are
Cushing’s Disease2
70%Patients suffer
hyperglycaemia after pasireotide
treatment3
EFFECTIVE TREATMENT IN THE ABSENCE OF
HYPERGLYCAEMIA
Global market for Cushing’s Syndrome1
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HTL30310 is the first SSTR5 selective somatostatin agonist
1 Clinical Trial Posting: https://clinicaltrials.gov/ct2/show/NCT03847207
CURRENTLY WHOLLY-OWNED
HTL30310SSTR5 somatostatin agonist
PHASE 1
Package of non-clinical GLP safety studies completed
Confirmed good safety margin vs. predicted clinical efficacious dose
Investigators Brochure and IMPD complete
Phase 1 clinical program initiated 1
• Double blind placebo controlled single ascending dose in healthy volunteers
• Two cohorts completed with no safety findings
Novel profile clearly differentiated from 1st Gen SSTR2 selective agonists Octreotide and Lanreotide and 2nd Gen non-selective Pasireotide (not effective and poorly tolerated)
Good observed PK in non-clinical species and good subcutaneous bioavailability across species
In vivo non-human primate data confirms HTL30310potential to avoid SSTR2 mediated hyperglycaemia
HTL30310 offers novel therapy with equivalent efficacy to pasireotide, with significantly improved safety and tolerability profile surrounding hyperglycaemia and GI side effects
Exploring potential of HTL30310 for use in Neuroendocrine Tumors (NETs) and treatment-resistant acromegaly
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Largeglobal migraine marketcovering awide indicationspectrum
Source: 1 EvaluatePharma; 2 The Migraine Trust
$8.3bnGlobal market in
20241
7thMost disabling disease among
all diseases2
DELIVERING A RAPID ONSET AND EXTENDED PERIOD OF PAIN RELIEF
Company Modality Name Indication Progress
Amgen S/C mAb Erenumab (Aimovig) Prophylaxis FDA Approved
Teva S/C mAb Fremanezumab (AJOVY) Prophylaxis FDA Approved
Alder IV mAb Eptinezumab Prophylaxis Phase 3 +ve
Lilly S/C mAb Galcanezumab (Emgality) Prophylaxis FDA Approved
Allergan Oral SME Ubrogepant Acute Phase 3 +ve; Filed
Biohaven Oral SME Rimegepant Acute Phase 3 +ve
Allergan Oral SME Atogepant Prophylaxis Phase 2b +ve
Biohaven IN SME BMS-742413/BHV-3500 Acute Phase I IN initiated
Anti-CGRP agents currently in clinical development
Outstanding value proposition for Acute Migraine• Clinically well validated mechanism
• High value market with high unmet medical need, with room for multiple players and modalities
• Additional potential for other severe/episodic cluster headaches and pain disorders
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Targeting intranasal delivery for a differentiated product profile
Note: SC = subcutaneous; IN = intranasal; PUL = pulmonary; SL = sublingual
Efficacy
Highest
Lowest
Safety BetterWorse
OralRimegepant/Ubrogepant
OralLasmiditan
HTL22562SC/IN/PUL/SL
• Efficacy similar to SC suma.• Superior safety profile
• Faster onset of action vs. orals• Superior efficacy vs. orals• Substantial sub-population of
migraineurs refractory to orals
SCSumatriptan
OralSumatriptan
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HTL22562 is a highly differentiated molecule preclinically
Clinical Trial Posting: https://clinicaltrials.gov/ct2/show/NCT03847207
CURRENTLY WHOLLY-OWNED
HTL22562CGRP antagonist
IDENTIFIED CLINICAL CANDIDATE
Progressing towards Phase 1 FTIH in [Q4 2019]
Highly promising follow-up program optimizing further highly differentiated molecules
Fast speed of action and greater efficacy vs. oralsPredicted fast onset and high exposure leading to improved pain freedom
Extended duration of actionPredicted EC99/EC90 receptor coverage for ~9hrs/~20hrs
Good safety and tolerabilityNo triptan sensations, serotonin side effects; Low risk of DILI
Potential for a strong clinical profile at low human efficacious exposures leading to superior speed, efficacy and safety profile
Predicted superior efficacy through rapid onset and long duration of action for parenteral administration
High solubility and predicted low risk of drug induced liver injury (DILI) due to differentiated physiochemical properties
High potency, competitive antagonist of CGRP and highly selective against closely related targets
Current development strategy provides opportunities for multiple routes of administration (e.g. intranasal, subcutaneous, pulmonary, sublingual)
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Our approach to GPCRs in the Gastrointestinal (GI) Tract
SIGNIFICANT $50 BN MARKET
~31 MILLION GI PATIENT VISITS / YR
~40 MILLION PRESCRIPTIONS / YR
RICH SOURCE OF GPCR TARGETS
MULTIPLE CLINICALLY VALIDATED MECHANISMS
OF ACTION
HIGH UNMET NEED
Mouth
Gastric EmptyingA
Oesophagus
Stomach
SmallIntestines
Small Intestinal TransitB
Colinic TransitC
Colon
WHO
LE GU
T TRANSIT = A
+ B+ C
Significant understanding of GI physiology Strategic GI Platform Approach
Establish target/ligand link to pathophysiology
Confirm efficacy in translational models
Determine functional effect and MoA in human primary cells and tissue
Design and optimize gut-restricted compounds and provide a higher margin of safety than
systemically absorbed compounds
High drug levels
Low drug levels
1
2
3
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Novel, selective GPR35 agonist for the treatment of IBD
Sosei Heptares uniquely positioned to rapidly develop and progress orally dosed GPR35 selective agonists – proven track record in cracking difficult GPCR drug targets
Developed a candidate quality GPR35 agonist molecule with minimized systemic exposure, excellent potency, selectivity and physiochemical properties
Potential to address unmet IBD needs through novel mechanism of action: potent immunomodulatory action plus anti-diarrhea and visceral pain control function
GPR35 is the target for a known anti-inflammatory asthma drug (cromoglycate) which has genetic association to IBD
Focus on chemistry design and optimization of high quality GPR35 agonists with low absorption and minimal systemic exposure
CURRENTLY WHOLLY-OWNED
UndisclosedGPR35 agonist
CANDIDATE SELECTION PHASE
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We are the world leader in GPCR drug discovery and developmentSolved
260+Molecularstructures
From
25+Different
GPCRs
Solved
>30%Structures of GPCR targets
~56% of viable GPCR
targets yet to be drugged
Significant opportunity to create new or
improved GPCR drugs
Decades of years left of GPCR drug
discovery potential
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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 beenprepared 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 specificinvestment 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 arecommendation 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 theCompany 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 noresponsibility 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 thispresentation, 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. Thewords “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 inthis 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 ourproducts), 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 bematerially 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 ourpresent 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 theforward 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, thecompetitive 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, ourrelationships 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 filedwith 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 oninformation 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 thisdocument 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 orcommitment 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 materialsare 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 beconsidered 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 (ineach 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 monthperiod 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 beconstrued accordingly.
Sosei Heptares is a trading name. Sosei and the logo are Trade Marks of Sosei Group Corporation, Heptares is a Trade Mark of Heptares Therapeutics Limited. StaR is a Trade Mark of Heptares Therapeutics Limited
Disclaimer
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Locations
SOSEI HEPTARES
PMO Hanzomon 11F
2-1 Kojimachi, Chiyoda-ku
Tokyo 102-0083
Japan
Steinmetz Building
Granta Park, Cambridge
CB21 6DG
United Kingdom
North West House
119 Marylebone Road
London NW1 5PU
United Kingdom