Nxera Pharma Co., Ltd. · TSE:4565
Nxera Pharma — Sosei Group — 41st Annual J.P. Morgan Healthcare Conference (January 2023)
31 slides from Nxera Pharma's conference presentation, Jan 11, 2023
Slide 1: Building Japan's Next Commercial Biotech
NON-CONFIDENTIAL Building Japan’s Next Commercial Biotech 41st Annual J.P. Morgan Healthcare Conference January 2023 | Sosei Group Corporation (TSE:4565)
Slide 2: Disclaimer
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
Slide 3: From humble beginnings…
From humble beginnings… 1990s 2005 TODAY 40+ programs 1990 - Founded by 2004 2015 across multiple current Chairman, Acquisition of therapeutic areas Shinichi Tamura Arakis, adding Acquisition of 20+ partnerships 1992 - ¥100m IPO on Tokyo Stock respiratory assets Heptares Therapeutics, with world lea
Slide 4: …to one of Japan's most innovative science-led biotech businesses
…to one of Japan’s most innovative science-led biotech businesses EVOLVING WITH A SPECIALIST Proprietary StaR® membrane THERAPEUTIC FOCUS protein stabilization technology Advancing a broad and deep Structure-based drug discovery pipeline of 40 partnered and platform, translational medicine in-house
Slide 5: Diversification of a big pharma, catalyst rich upside of a biotech
Diversification of a big pharma, catalyst rich upside of a biotech DISCOVERY PRECLINICAL AND PHASE 1 PHASE 2 SELECTED PARTNERED 10+ PROGRAMS 2x programs GLP-1 Ag 2x programs M4 Ag 1x program 1x program EP4 Ant SELECTED IN-HOUSE GPR52 Ag 10+ PROGRAMS EP4 Ag + Multiple others To be discuss
Slide 6: A differentiated business model that delivers
A differentiated business model that delivers 2022 MILESTONES LTM RELATIVE SHARE PRICE PERFORMANCE1 +15.1% New collaboration with Cancer Research UK for cancer immunotherapy -7.7% New multi-target collaboration with AbbVie for neurology diseases -26.2% M4 Ag Phase 2 IND acceptance by Neurocrine
Slide 7: Clear strategy to drive the business forward
Clear strategy to drive the business forward DRUG DISCOVERY TRANSLATIONAL MED. LATE STAGE CLINICAL COMMERCIAL 1 3 UK WORLD-LEADING TRANSFORMING DRUG DISCOVERY IN-HOUSE R&D 4 Japan ACTIVATING JAPAN COMMERCIAL BUSINESS 2 U.S. & E.U. Partners MAJOR MILESTONE / CASH FLOW GENERATING PARTNERSHIPS
Slide 8: Why GPCRs? The 'second golden age' of GPCR discovery is here
DISCOVERY PLATFORM PARTNERSHIPS TRANSFORMING R&D ACTIVATING JAPAN 1 Why GPCRs? The ‘second golden age’ of GPCR discovery is here ~400 NEUROLOGICAL DISORDERS GPCR targets active in diseases2 GASTROINTESTINAL DISEASES ~34% IMMUNOLOGY/ONCOLOGY of FDA approvals target GPCRs1 METABOLIC DISORDERS 27% CARD
Slide 9: World-leaders choose our platform to prosecute complex GPCRs
DISCOVERY PLATFORM PARTNERSHIPS TRANSFORMING R&D ACTIVATING JAPAN 1 World-leaders choose our platform to prosecute complex GPCRs Pre-Disc. / Discovery Preclinical studies Clinical studies Commercialization Multi-target Discovery Collaborations Total Potential Milestones1 Target ID Structure Hit ID L
Slide 10: Clinical stage partnerships (Muscarinic Programs)
DISCOVERY PLATFORM PARTNERSHIPS TRANSFORMING R&D ACTIVATING JAPAN 2 Clinical stage partnerships (Muscarinic Programs) Phase II initiated ‘22 Sosei Heptares received $100m upfront, +$30m @ Ph 2 Sosei Heptares to receive ongoing R&D funding and up to $2.6bn in potential development, regulatory and com
Slide 11: Clinical stage partnerships (Pfizer GLP-1 agonist for T2D and Obesity)
DISCOVERY PLATFORM PARTNERSHIPS TRANSFORMING R&D ACTIVATING JAPAN 2 Clinical stage partnerships (Pfizer GLP-1 agonist for T2D and Obesity) Phase II initiated ‘22 Well-positioned to compete on efficacy, tolerability and simplicity of administration vs. other oral therapies Source: Pfizer Quarterly Co
Slide 12: Doing R&D differently to enhance productivity, value and success
DISCOVERY PLATFORM PARTNERSHIPS TRANSFORMING R&D ACTIVATING JAPAN 3 Doing R&D differently to enhance productivity, value and success • Entrench target biology to understand TARGET disease processes BIOLOGY • Define robust and testable hypothesis • Fully integrated preclinical and clinical Higher qua
Slide 13: Multiple wholly-owned assets to begin clinical studies next 12 months
DISCOVERY PLATFORM PARTNERSHIPS TRANSFORMING R&D ACTIVATING JAPAN 3 Multiple wholly-owned assets to begin clinical studies next 12 months Indication Immunosuppression Schizophrenia Inflammatory and target in solid tumors and Psychosis Bowel Disease EP4 antagonist GPR52 agonist EP4 agonist • Once dai
Slide 14: Huge opportunity to create a disruptive pharma business in Japan
DISCOVERY PLATFORM PARTNERSHIPS TRANSFORMING R&D ACTIVATING JAPAN 4 Huge opportunity to create a disruptive pharma business in Japan Second Large, Universal FOCUS: underserved, Stable, pro- Relatively Attractive largest ageing health care specialty TA/DAs innovation weak market for pharma population
Slide 15: Our plan for Japan
DISCOVERY PLATFORM PARTNERSHIPS TRANSFORMING R&D ACTIVATING JAPAN 4 Our plan for Japan SEARCH DEVELOP BUILD EXECUTE Target product Mix of Build scale Expert team to opportunities in-licensing via virtual navigate clinical, in selected and organic R&D model regulatory and therapeutic areas developmen
Slide 16: Strategy to enhance our success
Strategy to enhance our success Japan Commercial Pharma Unit Major milestone generating partnerships Program-centric, TM-led R&D transformation Potential stock exchange up-listing Key initiatives over the next 3 years aimed at increasing corporate value 16
Slide 17: Our 2030 vision
Our 2030 vision Novel medicines on the market globally, through our collaborations with partners Commercial business in Japan, based on in-licensed and in time, own products Broad, deep and sustainable pipeline of programs with significant potential Rapidly growing sales, cash flow and profits Leadi
Slide 18: Appendix: Additional information
Appendix 1 Additional information 18
Slide 19: Board and Leadership team
Board and Leadership team Board of Directors Executive Management Senior R&D Leadership Shinichi Tamura Chris Cargill Dr. Alastair Brown Representative Executive Officer, Chairman of the Board Senior Vice President, Translational Medicine President and CEO Chris Cargill Hironoshin Nomura Dr. David H
Slide 20: Our unique and balanced business model continues to support a sustainable financial profile
Our unique and balanced business model continues to support a sustainable financial profile REVENUE (JPY million) OPERATING PROFIT (JPY million) 17,712 10,000 8,904 15,000 5,000 3,775 11,408 2,189 2,904 9,726 Upfront 10,000 8,842 384 928 OP 2,363 Milestone 0 3,505 FY18* FY19 FY20 FY21 Core OP 5,000
Slide 21: Partnered pipeline programs
Partnered pipeline programs Compound Target / Mechanism of Action Modality Indication Partner Disc. PreClin Ph1 Ph2 Ph3 App Mkt Partnered Seebri® Breezhaler® LAMA SME COPD Ultibro® Breezhaler® LAMA+LABA SME COPD Enerzair® Breezhaler® LAMA+LABA+ICS SME Asthma ORAVI® Antifungal agent miconazole SME Or
Slide 22: Partnered pipeline programs (cont'd)
Partnered pipeline programs (cont’d) Compound Target / Mechanism of Action Modality Indication Partner Disc. PreClin Ph1 Ph2 Ph3 App Mkt Co-development KY1051 CXCR4 mAb mAb Immuno-oncology Not disclosed PAR-2 Peptide Inflammatory diseases Not disclosed Targeted Protein Degradation SME Gastrointestin
Slide 23: In-house pipeline programs
In-house pipeline programs Compound Target / Mechanism Modality Indication Originator Disc. PreClin Ph1 Ph2 Ph3 App Mkt In-house Programs Not disclosed H4 antagonist SME Atopic Dermatitis HTL0039732 EP4 antagonist SME Immuno-oncology Not disclosed GPR52 agonist SME Neurology diseases Not disclosed E
Slide 24: Appendix: Summary of wholly-owned programs targeting FTIH in 2023
Appendix 2 Summary of wholly-owned programs targeting FTIH in 2023 24
Slide 25: EP4 Antagonist
EP4 Antagonist Background & Executive Summary Target & Disease indication(s) Executive Summary • EP4 mediating PGE2 immunosuppression • Proprietary StaR® technology used to identify highly potent and selective • Combination with checkpoint inhibitors (CPI’s) in cancers with high expression of PGE2 a
Slide 26: EP4 Antagonist in Oncology – Proposed Mechanistic Hypotheses
EP4 Antagonist in Oncology – Proposed Mechanistic Hypotheses 1. Epithelial tumour cells secrete large quantities of PGE2 into the TME. 2. PGE2 increases proliferation of some tumours and thereby increases their metastatic potential. 3. PGE2 propagates an immunosuppressive TME; stimulates MDSC differ
Slide 27: GPR52 Agonist
GPR52 Agonist Background & Executive Summary Target & Disease indication(s) Executive Summary • Oral small molecule GPR52 agonist • Schizophrenia • Therapy to address positive symptoms, negative symptoms and cognitive • Psychosis and/or cognitive decline in dementias impairment in schizophrenia, wit
Slide 28: GPR52 Agonist Target Rationale
GPR52 Agonist Target Rationale Treatment of positive symptoms and cognitive dysfunction in Schizophrenia Striatopallidal neurons Prefrontal cortical neurons Rationale • GPR52 receptors principally co-located with D2 and D1 receptors • D2 in Medium Spiny Neurons • D1 in Prefrontal Cortex • GPR52 Acti
Slide 29: GI restricted EP4 Agonist for the treatment of IBD
GI restricted EP4 Agonist for the treatment of IBD Background & Executive Summary Target & Disease indication Executive Summary • Inflammatory bowel disease (IBD) • EP4 represents an attractive target for the treatment of IBD • Strong mechanistic rationale in IBD supported by human genetic evidence.
Slide 30: Oral GI restricted EP4 agonist for the treatment of IBD
Oral GI restricted EP4 agonist for the treatment of IBD Proposed Mechanistic Hypotheses Proposed benefits of EP4 agonist Intestinal homeostasis – EP4 accelerates mucosal healing via promoting regeneration and repair of damaged epithelial mucosa. EP4 agonists promote barrier function via direct act
Slide 31: Locations
Locations SOSEI GROUP PMO Hanzomon 11F Steinmetz Building North West House 2-1 Kojimachi, Chiyoda-ku Granta Park, Cambridge 119 Marylebone Road Tokyo 102-0083 CB21 6DG London NW1 5PU Japan United Kingdom United Kingdom
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