Transcenta Holding Limited · HKEX:6628
Transcenta — FY2022 Earnings Presentation
33 slides from Transcenta's earnings presentation, March 2023
Slide 1: Company Presentation
COMPANY PRESENTATION March 2023
Slide 2: Disclaimer
Disclaimer • The information and opinions contained in this presentation are provided as of the date of this presentation, are subject to change without notice and will not be updated or otherwise revised to reflect any developments, which may occur after the date of the presentation. • This present
Slide 3: Today's Agenda
Overview 01 Today’s Business 02 Agenda Financial & Outlook 03 Q&A 04
Slide 4: Company Overview
PART 01 Company Overview Vy J, (7, EB @ TRANSCENTA
Slide 5: An Integrated Organization with Global Footprint
Company Overview An Integrated Organization with Global Footprint Lead Industry Leading Global World-Class Discovery Technology Clinical Strategy & CMC & CDMO Translational Research Platforms Execution Capability Amsterdam Beijing Clinical / Regulatory Clinical / Regulatory Shanghai Clinical/ Busine
Slide 6: Achievements in 2022
Company Overview Achievements in 2022 5 8 ~100% YoY Ongoing Clinical Programs New Patent Granted Total Revenue Growth Clinical Development Patents and Research CDMO Business 1 2 11 51 3 101.9m +80% 30+ RMB TST001 to start New IND Data read-outs New Patent New Pipeline Total Revenue External Contract
Slide 7: Business
PART 02 Business Vy J, (7, EB @ TRANSCENTA
Slide 8: Pipeline Highlights
Business Pipeline Highlights Oncology Antibody-Based Approach Targeting Cancer Cells, Tumor Stromal Cells, Angiogenesis and Immune Cells TST013 TST012 TST010 TST003 TST005 MSB0254 ADC mAb T regulatory cell (First-In-Class) (Best-In-Class) (Differentiated) depleting mAb Novel Target PDL1-TGF-β VEGFR2
Slide 9: CLDN18.2 is a Clinically Validated Target
Business Osemitamab (TST001) CLDN18.2 is a Clinically Validated Target – TST001 as a Next Generation Agent Targeting Broader Population in Combination with Checkpoint Inhibitors SPOTLIGHT and GLOW results: GLOW discussion by Pr Janjigian (MSKCC) • Significant improvements PFS and OS • In combination
Slide 10: The 2nd Leading Anti-CLDN18.2 mAb with a Differentiated Profile vs. Zolbetuximab
Business Osemitamab (TST001) The 2nd Leading Anti-CLDN18.2 mAb with a Differentiated Profile vs. Zolbetuximab Enhanced ADCC activity for CLDN18.2 low expressing gastric cancer cells Humanized antibody Mean Fluorescence Intensity 80,000 TST001 60,000 IMAB362-analog Higher binding affinity Isotype con
Slide 11: Robust Anti-tumor Activities in First Line G/GEJC Patients
Business Osemitamab (TST001) Robust Anti-tumor Activities Seen in the First Line G/GEJC Patients Regardless of the Claudin18.2 Expression Levels (≥10%, ≥1+ by LDT assay) Treatment Duration and Tumor Assessment Encouraging Safety and Efficacy in Dose Expansion In combination with CAPOX 73.3% 11 out o
Slide 12: CDx Ready for Phase 3 in 1L G/GEJC
Business Osemitamab (TST001) CDx Ready for Phase 3 in 1L G/GEJC. Better Specificity for Enabling Patient Selection in Tumors beyond GI Cancers HEK293/CLDN18.1 cell HEK293/CLDN18.2 cell CLDN18.2 14G11 CDx (Prototype) GC182(0.2μg/ml) 14G11(0.15μg/ml) GC182: Transcenta produced based on publicly availa
Slide 13: Synergy between TST001 and Nivolumab
Business Osemitamab (TST001) Synergy Demonstrated between Targeted Therapy TST001 and Checkpoint Inhibitor Nivolumab Potential MOA for Synergy with PD1/Chemo CLDN18.2 (100%)/PDL1+ Syngeneic Model CLDN18.2 (>95%)/PDL1-Negative PDX Model 13
Slide 14: Leapfrog Competition by Accelerating PD1 Combination in 1L G/GEJC
Business Osemitamab (TST001) Leapfrog Competition by Accelerating PD1 Combination in the 1L G/GEJC NCT04495296 NCT04396821 TST001 + Nivolumab + CAPOX – 1L G/GEJ cancer TST001 + Nivolumab + FOLFOX6 – 1L G/GEJ cancer TST001 6mg/kg + TST001 6mg/kg + Nivolumab + CAPOX Q3W Cohort Cohort G TST001 2mg/kg Q
Slide 15: Osemitamab Phase Ready Q3 2023
Business Osemitamab (TST001) 2022 2023 Phase 3 ready – Q3 2023 03 Osemitamab (TST001) + Nivolumab + Chemo 1L G/GEJ adenocarcinoma 02 • Initiated Ph1b trials for osemitamab Additional plans for: • Peri-operative G/GEJ cancer • PDAC 01 • Reported exciting Ph1b data for (TST001) + Nivo/chemo combo in b
Slide 16: Global Program to Develop Osemitamab as Cornerstone Treatment
Business Osemitamab (TST001) Global Program to Develop Osemitamab as the Cornerstone Treatment in CLDN18.2 Expressing Tumors Therapy Lines Late Line First Line Peri-operative Gastric Cancer (+PD1) (+Chemo) (PD1+ Chemo) (PD1+Chemo) Indications Pancreatic Cancer (+Chemo) Other Solid Tumors including L
Slide 17: The Promise of Osemitamab (TST001)
Business Osemitamab (TST001) The Promise of Osemitamab (TST001) Well validated target 2nd most advanced program CDx Global Development Plan & globally and with Potential for differentiated profile with phase 3 ready for 1L mGC CMC ready Multiple Indications • ADCC enhanced • Accelerating the develop
Slide 18: TST003: First-In-Class mAb with Anti-tumor Activities
Business TST003 First-In-Class mAb with Potential Anti-tumor Activities in Multiple Tumor Types MoA Efficacy Publication Single agent activity in PDL1 negative/ refractory PDX model Green: Stromal fibroblast Dongre, A., et al Cancer Discovery 2020 DOI: 10.1158/2159-8290.CD-20-0603 Potent anti-tumor
Slide 19: TST002: Differentiated Antibody for Bone Diseases
Business TST002 A Well Differentiated Monoclonal Antibody for Bone Diseases, Licensed from Eli Lilly with Phase II Data in US and Japan Dual Mechanisms Favorable Characteristics Dual effect target Efficacy • 17% BMD increase in Spine and 6.2% in total hip at week 52 in Phase II study Resorption Form
Slide 20: TST004: Anti-MASP2 Antibody with Differentiated Properties
Business TST004 An Anti-MASP2 Antibody with Differentiated Properties Multiple Potential Indications Superior Product Profile C3G/ IgA nephropathy (IgAN) Lupus nephritis/MN/aHUS Dosing • Subcutaneous formulation • Potentially less frequent dosing AMD/STGD1/Uveitis Binding affinity • High binding aff
Slide 21: TST012 & TST013: Emerging Oncology Candidates
Business TST012 & TST013 Emerging Pipeline of Oncology Drug Candidates TST012 • ADCC enhanced mAb candidate for gastric cancer, lung cancer etc. • Lead antibody selected • TST012 showed potent anti-tumor activities in preclinical tumor model • IND enabling study to start • Benchmark program in Ph3 T
Slide 22: TST008 & TST801: Emerging Auto-Immune Candidates
Business TST008 & TST801 Emerging Pipeline of Auto-Immune Drug Candidates TST008 • FIC bispecific antibody targeting MASP2 and receptors involved in regulating B cell activation and differentiation • Target indications: SLE, LN & IgAN • Lead molecule selected showed a potent inhibition on MASP2 depe
Slide 23: Diversified and Differentiated Pipeline
Business Diversified and Differentiated Pipeline Pivotal Drug Clinical trial Phase 1b/ Target Indications Preclinical IND Phase 1a Phase 2b / Rights Partner candidate region Phase 2a Phase3 1L China Combo with Chemo 1L Global Combo with Nivolumab/Chemo GC 2/3L Global Combo with Nivolumab 2L Global C
Slide 24: CMC & CDMO
Business CMC & CDMO Flawless Execution with Increased Efficiency, Global Quality Standard and Commercial Manufacturing Readiness Faster QP Audit Industry Leading perfusion Passed audit by the European productivity of > 7g/L-day, > 15-fold Union Qualified Person (QP) increase in output • ↑↑↑ facility
Slide 25: Business Development: Multinational Partners
Business Business Development Multinational Partners to Maximize Asset Value and Accelerate Development Clinical Trial Collaboration In-License OUR Research Collaboration PARTNERSHIPS Technology-based Partnership Joint Venture 25
Slide 26: Financial & Outlook
PART 03 Financial & Outlook Vy J, (7, EB @ TRANSCENTA
Slide 27: 2022 Financial Results
2022 Financial Results Healthy Financial Profile and Well Capitalized for Growth Initiatives Key Income Statement Metrics Revenue Other Income + 102.8% + 41% 101.9 46.4 32.9 50.2 RMB 101.9 million RMB 46.4 million 2021 2022 2021 2022 R&D expenses Administrative expenses (non-IFRS) (non-IFRS) - 10% 3
Slide 28: Outlook
Outlook Integrated Platform, Cutting-edge Technology, Differentiated and Competitive Biologics Oncology Osemitamab (TST001) TST003 Novel Agents • Initiate a global pivotal trial for the 1L G/GEJ • Continue phase I study to enable • Advance new pipeline molecules into IND- adenocarcinoma patients com
Slide 29: Outlook
Outlook Integrated Platform, Cutting-edge Technology, Differentiated and Competitive Biologics Clinical Development Research • Present data for TST001 and TST002 • Initiate IND enabling study • Accelerate clinical development • Expand pipeline by designing • Initiate global Phase III trial for innov
Slide 30: Q&A
PART 04 Q&A Vy J, (7, EB @ TRANSCENTA
Slide 31: Thank You!
THANK YOU! ir@transcenta.com
Slide 32: Appendix
Appendix Vy J, (7, EB @ TRANSCENTA
Slide 33: Strong Team
Company Overview Strong Team Seasoned Management Team World-class Renowned SAB Briggs Morrison, M.D. Scientific Advisory Board Chairman Xueming Qian, Ph.D. Frank Ye, Ph.D. Caroline Germa, M.D. Executive Partner | MPM Capital Co-Founder and CEO EVP, COO EVP, CMO President | Syndax Pharma Former CMO |