Edding Genor Group Holdings Limited · HKEX:6998
Edding Genor — FY2021 Earnings Presentation
37 slides from Edding Genor's earnings presentation, March 2022
Slide 1: 2021 Annual Results Presentation
2021 Annual Results Presentation March 2022 0
Slide 2: Disclaimer
Disclaimer By receiving this document or attending the meetings at which this document is presented, you agree to be bound by the following restrictions: This document is provided to you solely for your exclusive use and information and is not for public dissemination. The information contained in t
Slide 3: Agenda
Agenda Business Review 1 2 Pipeline Introduction Upcoming Milestones 3 4 Financial Overview 2
Slide 4: Business Review
Ot as * oy Business Review e PHARMA
Slide 5: Vision – Global Innovative Biotech Company
Vision – Global Innovative Biotech Company Source Innovation • Adjusted the priorities of • Established FIC / BIC original product pipelines potential drug discovery • Focus on the product platform focusing on IO pipelines with higher added bi/multi-specific antibodies values Establish global Driven
Slide 6: Business Highlights from 2021
Business Highlights from 2021 Chief Scientific Officer-Shuhua Han, Ph.D. on board in Jan. 2021 1 BLA approved by NMPA Swiftly built team with 30 members GB242 (Infliximab Biosimilar) NDA and established IO Bs/MsAb FIC/BIC approval potential drug discovery platform 1 NDA under review by NMP
Slide 7: Key Milestones in Late-stage Pipeline from 2021
Key Milestones in Late-stage Pipeline from 2021 1 NDA approval, 1NDA under technical review and advancing 2 Ph3 clinical trials Commercial Key Product Description Trials / Indication Stage Rights Milestones CDK4/6+AI (combo w/ letrozole): Phase 3 FPD(2) 1L HR+/HER2- BC(1) a novel, potent, selective
Slide 8: Commercial Operation and Manufacturing for Late-stage Pipeline
Commercial Operation and Manufacturing for Late-stage Pipeline Commercial Operation Foundation Yuxi Commercial Manufacturing Site Hybrid model for product commercialization Core market: Small, capable, well-rounded commercial team of our own for core market to manage branding, market access, prici
Slide 9: Key Milestones in Early-clinical-stage Pipeline from 2021
Key Milestones in Early-clinical-stage Pipeline from 2021 Trials / Commercial Product Description 1Q 2Q 3Q 4Q 1Q22 Indication Rights a stimulator of interferon genes (STING) Ph1 IND APAC Ph1/2a 400μg group GB492 agonist expected to exert synergistic Solid Tumors Mono or ex-JP FPD finished effects in
Slide 10: New Discovery-stage Pipeline from 2021: Focusing on IO FIC/BIC Potential Antibodies
New Discovery-stage Pipeline from 2021: Focusing on IO FIC/BIC Potential Antibodies While Exploring Cutting-edge Technology Discovery-stage pipeline in 2021 Novel discovery from 2022 pipeline Indications Lead discovery FIC / BIC potential Comprehensive assessment before GBD201 NSCLC, ESCC,other so
Slide 11: FIC/BIC Potential Drug Design Strategy and Integrated Development Platform
FIC/BIC Potential Drug Design Strategy and Integrated Development Platform Immune Network FIC/BIC Potential Drug Design Strategy 1. Focus on frontier IO targets 2. Various mechanism and targets to co-regulate the core pathways of the immune network 3. Specifically target to tumor microenvironment re
Slide 12: Scientific Advisory Board, Accelerating Global Innovation
Scientific Advisory Board, Accelerating Global Innovation Dr. Zhijian Dr. David Dr.Alex Dr. Leonard Dr. John R. Dr. John F. Dr. Yangxin CHEN Kerr A. Adjei Saltz Zalcberg OAM Seymour FU Professor at Professor of Professor at the Professor of Cancer Professor, Professor of Professor at the University
Slide 13: Seasoned Management Team with Proven Track Records
Seasoned Management Team with Proven Track Records Dr. Feng GUO Dr. Shuhua HAN Dr. Joe ZHOU Ms. Tong LI Mr. Wende CHEN Mr. Qibin Liang Mr. Mark F. KUBIK Ms. Yao CHEN 注册事务 Chairman of the Chief Scientific Chief Medical Chief Operation Chief Technology Chief Business Head of Regula- President 高级副总裁 Bo
Slide 14: End-to-end Integrated Platform
End-to-end Integrated Platform Discovery CMC IO bi/multi-specific antibody Proven CMC capability FIC/BIC potential drug design platform Continuous-flow cell culture Immune check point inhibitor technology T-Cell Engager for solid tumors Bi/tri-specific antibody with higher Cytokines
Slide 15: Pipeline Introduction
02 Pipeline Introduction
Slide 16: A Robust Pipeline- Development Stage Assets Focusing on Global Opportunities
A Robust Pipeline- Development Stage Assets Focusing on Global Opportunities Target/MoA Commercial Pre – Product Indication Classification Discovery IND Phase 1 Phase 2 Pivotal NDA (reference drug) Rights Clinical CDK4/6+AI (combo w/ letrozole) 1L HR+/HER2- BC GB491 CDK4/6+SERD (combo w/ fulvestrant
Slide 17: Portfolio Strategy Centered Around the Cancer-Immunity Cycle
Portfolio Strategy Centered Around the Cancer-Immunity Cycle Tumor cell Priming and activation T-Cell (APCs & T-cells) GB265 (PD-L1/TIGIT) Antigens • Engineered cytokines • TGF-β trap GB266 (PD-L1/LAG3/LAG3) T-cell recognition • T-cell agonists • 4-1BB, CD27, GITR, ICOS, OX- T-cell immune response 4
Slide 18: GB491 (Lerociclib) – Well-positioned to Capture the Huge Breast Cancer Markets in APAC
GB491 (Lerociclib) – Well-positioned to Capture the Huge Breast Cancer (eBC & mBC) and HNSCC Markets in APAC FPD for 2L HR+/HER2- BC Ph3 trial in Oct 2021, FPD for 1L HR+/HER2- BC Ph3 trial in Jan 2022 We hold development and commercial rights in APAC excluding Japan We are the second domestic c
Slide 19: GB491 (Lerociclib) – Potentially Best-in-Class CDK4/6 Inhibitor
GB491 (Lerociclib) – Potentially Best-in-Class CDK4/6 Inhibitor Superior Efficacy Profile & Better Tolerability Higher ORR vs. Palbociclib in Paloma-3 Trial Longer treatment duration requires therapeutics withbetter tolerability Lerociclib Phase Eli Lilly Pfizer Novartis ~30 24-60 1/2a (ongoing) 1 M
Slide 20: GB491 – Advancing Phase 3 Clinical trials
GB491 – Advancing Phase 3 Clinical trials FPD E-2023 Ph3 IND 2L: (GB491 + Phase 3 registration trial (270 subjects) 2021.10 Deal Signed Approval Fulvestrant) NDA Submission 2020.06 2021.05 2021.07 FPD E-2024 1L: (GB491 + Ph3 IND Letrozole) 2022.01 Phase 3 registration trial (270 subjects) Submission
Slide 21: Other key Late Stage Candidates GB242 and GB226
Other key Late Stage Candidates GB242 and GB226 GB242 – Infliximab biosimilar GB226 – PD-1 Biosimilar product candidate to Infliximab. Humanized, IgG4 mAb targeting the PD-1 receptor on immune cells. Indications: Rheumatoid Arthritis (RA), Selectively blocks dual ligands (PD-L1 and Ankylosin
Slide 22: GB492 – A Potentially First-in-class STING Agonist in China
GB492 – A Potentially First-in-class STING Agonist in China Ph1/2 FPD in Sep 2021 STING agonist, as an immune stimulatory therapy, may further Mechanism of Action increase the response of immune checkpoint inhibitors for patients Merck’s trial demonstrated robust efficacy of PD-1 + STING combination
Slide 23: GB492 – Advancing Clinical Development
GB492 – Advancing Clinical Development EC Combo IND Submission Approval FPD 2020.06 2021.03 2021.05 2021.07 2021.09 E-2H 2022 IND Deal Signed Approval Mono FPD Progress achieved in 2021: IND Approval for an innovative FIH trial Design combining 2 dose escalation in one study GB492 mono GB492 +
Slide 24: GB261 – A Highly Differentiated CD20/CD3 BsAb for B-cell Lymphoma
GB261 – A Highly Differentiated CD20/CD3 BsAb for B-cell Lymphoma FIH FPD in AUS in Oct 2021 The first T-cell engager with super low CD3 binding affinity and maintaining Fc effector functions (ADCC and CDC) , rendering better safety and multiple mechanisms to better kill cancer cells. CDR grafting a
Slide 25: GB261 Significantly Inhibits Rituximab-resistant Tumor Growth (in vivo)
GB261 Significantly Inhibits Rituximab-resistant Tumor Growth (in vivo) GB261 induces more Rituxan-resistant Raji cell killing in PMBC-engrafted B-NDG mice than REGN1979 analog. Inoculation BLI and grouping Study endpoint Antibody, IV (1 mg/kg) Antibody, IV (1 mg/kg) HLA-matched hPBMC, IV Vehicle D-
Slide 26: GB261 Induces T cell Activation with Less Cytokine Releases
GB261 Induces T cell Activation with Less Cytokine Releases GB261 stimulates less cytokine release compared to that of REGN1979 analog. T cell activation E/T 1:1 ABS (GB261) REGN1979 Control Target cells: Rituxan resistant Raji cells Effector cells: human PBMC EC50 EC50 EC50 EC50 GB261 – ~2.112e-010
Slide 27: GB261 Clinical Data Conforms to MOA and Pre-clinical Discovery
GB261 Clinical Data Conforms to MOA and Pre-clinical Discovery Preliminarily showed better safety at 20-200 times of starting dose Mosunetuzumab Odronextamab Glofitamab Drug Candidate GB261 (RG7828) (REGN1979) (RG6026) Starting Dose 1mg 50μg 30 μg 5 μg PK and cytokine data from 1mg dosed group confo
Slide 28: GB261 – Advancing Clinical Development
GB261 – Advancing Clinical Development FIH AUS clinical trial application Initial Clinical Submission Readout 2019.12 2021.03 2021.06 2021.10 2022 Q1/Q2 CMC Kick-off AUS EC/CTN FPD in AUS Approval Clinical and Regulatory Progress in 2021: Clinical Development Plan: Optimized Dose Escalation and Ex
Slide 29: GB263T – the First EGFR/cMET/cMET Tri-specific Antibody for NSCLC
GB263T – the First EGFR/cMET/cMET Tri-specific Antibody for NSCLC Global rights, global innovation, blockbuster potential In comparison with JNJ-61186372，GB263T is differentiated in design GB263T JNJ-61186372 (Amivantamab) Multiple MOAs Inhibit EGFR/c-MET relevant signaling EGFR EGFR Mediate rec
Slide 30: GB263T – Advancing FIH IND and Clinical Trials
GB263T – Advancing FIH IND and Clinical Trials EC approved for FIH AUS clinical trial and China IND submission accepted by NMPA in Mar 2022 FIH AUS Clinical FIH AUS Clinical Pre-Tox Study in Monkey trial Submission trial EC Approval 2020.12 2021.06 2021.08 2021.12 2022.03 CMC Kick-off CN IND Submiss
Slide 31: Upcoming Events
! OS ~_ 2) ~ c o > Lu oO) = = 2) 1S) [os =)
Slide 32: Upcoming Milestones
Upcoming Milestones Key Events Timing GB242 (TNF-α) – Commercial Launch 2022 GB226 (PD-1) – NDA approval for 2L r/r PTCL 2022 GB492 (STING) – FPD combined with GB226 2H2022 GB261 (CD20/CD3) – IND approval in China 2H2022 GB261 (CD20/CD3) – Initial POC readout 2H2022 GB263T (EGFR/cMet/cMet) – IND app
Slide 33: Financial Overview
04 Financial Overview
Slide 34: Financial Overview – Income Statement
Financial Overview – Income Statement Year Ended 31 December RMB' mn 2021 2020 Revenue - 10.3 Cost of revenue - (2.6) Expenses Gross profit - 7.7 R&D expenses decreased, mainly due to the decrease of employee share-based payment Selling expenses (98.6) - expenses. Administration expenses (207.4) (
Slide 35: Financial Overview – Balance Sheet
Financial Overview – Balance Sheet RMB' mn Dec-21 Dec-20 Cash and cash equivalents 2,200.6 2,929.7 Restricted bank deposits 2.0 2.0 Inventories 49.7 31.5 Contract cost 1.8 1.8 Other receivables, deposits and prepayments 132.5 108.7 Cash Balance Amounts due from related parties 0.0 27.7 As at Decem
Slide 36: Intention to Conduct On-market Share Repurchase
Intention to Conduct On-market Share Repurchase up to HK$50,000,000 in value of the Shares Finance by its internal resources The board announced that it intends to exercise its authority under the general mandate (the “Repurchase Mandate”) to repurchase shares of the The Company intends to finance t
Slide 37: <3 oO
<3 oO
Edding Genor Group Holdings — FY2021 Earnings Presentation on 6ix