Transcenta Holding Limited · HKEX:6628
Transcenta — FY2021 Earnings Presentation
36 slides from Transcenta's earnings presentation, Mar 22, 2022
Slide 1: 2021 Annual Results
2021 ANNUAL RESULTS March 2022
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
Today’s Agenda 01 Company Overview & 2021 Highlights 02 Pipeline Update 03 Business Development 04 CMC Update 05 Financial Results & 2022 Outlook 06 Q&A
Slide 4: Company Overview & 2021 Highlights
Company Overview & 1 2021 Highlights
Slide 5: Transcenta at a Glance
Transcenta at a Glance Industry Leading Global Vision Innovative Clinical World-Class CMC Team & Technology Platforms from Inception Strategy & Execution CDMO Capability With end-to-end capabilities across Drug candidates with Integration of clinical and Experienced in-house team, • Discovery & Rese
Slide 6: Transcenta is an Integrated Biopharma with Global Footprint
Transcenta is an Integrated Biopharma with Global Footprint Proprietary Antibody Discovery Platform yields candidates with Discovery • Superior differentiated characteristics • Stronger IP position Beijing New Jersey Clinical / Regulatory Clinical / Regulatory Comprehensive Translational Research St
Slide 7: Seasoned Management Team and World-class Scientific Advisory Board
Seasoned Management Team and World-class Scientific Advisory Board Experienced Management Team International Renowned SAB Seasoned and global management team with solid knowledge and World Well-known leading academic investigators, experience across value chain regulatory experts and industrial vete
Slide 8: Diversified and Differentiated Pipeline
Diversified and Differentiated Pipeline Clinical Pivotal Drug Phase 1b/ Target lndications trial Preclinical IND Phase 1a Phase 2b / Rights Partner candidate phase 2a region Phase3 Late-line gastric cancer China Monotherapy Late-line pancreatic cancer Global Monotherapy Other late-Line solid tumors
Slide 9: 2021 Highlights
2021 Highlights Strong Progress in Pipeline Advancement and Business Operations Advanced lead asset TST001 in multiple indications and planning for global registration study ✓ Initiated phase IIa trials for late-line gastric cancer and pancreatic cancer ✓ Began a phase I trial in combination with ch
Slide 10: Pipeline Update
2 Pipeline Update
Slide 11: Transcenta Pipeline Highlights
Transcenta Pipeline Highlights TST001 (Best-In-Class) CLDN18.2 Global Ph IIa Stage Gastric, pancreatic and TST002 (Differentiated) other solid tumors Sclerostin Ph I Stage (US Ph II Completed) Osteoporosis Osteogenesis Imperfecta TST005 (Best-In-Class) Osteoporosis in CKD PDL1-TGF-β Oncology Non-Onc
Slide 12: Oncology Highlights
Oncology Highlights Targeting Checkpoint Inhibitor Resistant/Refractory Tumors ✓ Targeting major cancer pathways with differentiated biologics • CLDN18.2, a well validated tumor associated antigen • PD1/PDL-1-TGFb pathway, a key MOA for PD1 resistance • Cancer associated stromal cells, source of imm
Slide 13: TST001: A Second Generation Claudin18.2 Antibody with FIC / BIC Potential
TST001 A Second Generation Claudin18.2 Antibody with FIC / BIC Potential CLDN18.2 is a Clinically Validated Target with Potential in Broad Indications IMAB362 Clinically Validated Efficacy and Safety Esophageal Cancer CLDN18.2: 18% - 60% Expression Pancreatic Cancer 30% Medium-high Expression Better
Slide 14: TST001: Leading the Market with Promising Anti-tumor Activities
TST001 A Second Generation Claudin18.2 Antibody with FIC / BIC Potentials Leading the Market with Promising Anti-tumor Activities and BIC / FIC Potentials The second leading mAb targeting CLDN18.2 developed globally following Zolbetuximab, but shows a differentiated profile with BIC/FIC potentials •
Slide 15: TST001: Confirmed PR in Late Line Gastric Cancer
TST001 A Second Generation Claudin18.2 Antibody with FIC / BIC Potential One Confirmed PR Achieved in Dose Escalation Study in Late Line GC Patient at 6mg/kg Confirmed PR in heavily pretreated GC patient • Male, 42-year-od, GC/peritoneal metastasis • Multiple lines of prior treatment, including chem
Slide 16: TST001: Confirmed PR in Pre-treated Pancreatic Cancer
TST001 A Second Generation Claudin18.2 Antibody with FIC / BIC Potential Confirmed PR in Pre-treated Pancreatic Cancer Patient with Medium-low CLDN18.2 Expression Confirmed PR in pretreated pancreatic cancer • Male, 64-year-od, pancreatic cancer patient with liver metastasis • Prior treatment, gemci
Slide 17: TST001: Global Program to Expand Indications
TST001 A Second Generation Claudin18.2 Antibody with FIC / BIC Potential Global Program to Expand Indications beyond Gastric and Pancreatic Cancers ◼Cohort Expansion CLDN18.2 Pancreatic cancer ◼CLDN18.2 selected (negative) and other CLDN18.2+ tumors ~50% PC Late line gastric cancer CLDN18.2+ GC (All
Slide 18: TST001: Significant Progress Made in 2021
TST001 A Second Generation Claudin18.2 Antibody with FIC / BIC Potential Significant Progress Made in 2021 Execution Speed Secured Transcenta’s Global #2 Position Gained Translational Completed CMC for Obtained FDA Orphan Initiated Global Clinical Development Insights Pivotal Trial Drug Designation
Slide 19: TST003: A First-In-Class Humanized Antibody Candidate
TST003 TST003 A First-In-Class A First in Class Humanized Humanized Antibody Candidate Antibody for PD1 Resistant Candidate Tumors for PD1 Resistant Tumors First-In-Class mAb with Anti-tumor Activities in I/O Refractory Tumor Models TST003(14E3) PD-L1(22C3) TGF-β(EPR21143) 500 PDX Human Immune Syste
Slide 20: Non-oncology Highlights
Non-oncology Highlights Expand into large and untapped opportunities in bone and kidney diseases ✓ Highly differentiated pipelines targeting bone and kidney diseases • TST002: a humanized sclerostin antibody for postmenopausal osteoporosis and other bone diseases • TST004: a humanized MASP-2 antibod
Slide 21: TST002: A Well Differentiated Humanized Anti-Sclerostin Antibody
TST002 A Well Differentiated Humanized Anti-Sclerostin Antibody for Bone Diseases A Monoclonal Antibody Licensed from Eli Lilly with Phase II Data in US and Japan Dual Mechanism of Bone Formation and Anti-resorption TST002: Favorable Product Characteristics Throughout Value Chain Dual effect target
Slide 22: TST002: Osteoporosis is an Increasing Burden
TST002 TST002 A Well Antibody Humanized Anti-Sclerostin Differentiated Humanized for Severe OsteoporosisAnti-Sclerostin Antibody for Bone Diseases Osteoporosis is an Increasing Burden on Health and Society High Unmet Medical Needs Large Market Potential Market size of China anti-sclerostin drugs Key
Slide 23: TST004: An Anti-MASP2 Antibody
TST004 TST004 An Anti-MASP2 An Anti-MASP2 Antibody Antibody with Favorable with Inhibitory Lectin Pathway Favorable Lectin Activity andPathway Inhibition PK/PD Profile Potential Solution for IgAN, A Highly Prevalent Chronic Kidney Disease and Other Complement Mediated Diseases Superior Product Profi
Slide 24: TST004: Successful Joint Venture Partnership Formed
TST004 TST004 An Anti-MASP2 An Anti-MASP2 Antibody Antibody with Favorable with Inhibitory Lectin Pathway Favorable Lectin Activity andPathway Inhibition PK/PD Profile Successful Joint Venture Partnership Formed A Joint Venture with Alebund Pharmaceuticals Progress Made Product Advantage ✓ Develop a
Slide 25: Research: Drug Discovery & Translational Research
Research Drug Discovery & Translational Research Our Proprietary Antibody Discovery Platform Delivers Candidates with Superior Profiles IMTB Platform Advantages Potential FIC & BIC Molecules Discovered w/ IMTB TST001 (BIC, CLDN18.2) Target protein A potent therapeutic candidate co-developed with spe
Slide 26: Research: Shape Up an Innovative and Risk-balanced Pipeline
Research Drug Discovery & Translational Research Shape Up an Innovative and Risk-balanced Pipeline Win CLDN18.2+ Tumors Target CPI Resistance Non-Oncology Diseases Translational Science Establish internal Understand CPI Focus on the selected Utilize cutting-edge expertise in resistance mechanisms ta
Slide 27: Business Development
3 Business Development
Slide 28: Business Development: Partnership Strategy
Business Development Multinational partners to maximize asset value and Increase Productivity Partnership Strategy Identify, evaluate and build new technology platforms through external Platform collaboration and Engage multi-national Advancement partnership pharma/biotech partners to speed up devel
Slide 29: Our Partnerships
Business Development Multinational partners to maximize asset value and Increase Productivity Our Partnerships ◼Research Collaboration ◼Clinical Development ◼Joint Venture Collaboration • A global clinical collaboration with BMS to evaluate the combination of TST001 with • A Joint Venture with Alebu
Slide 30: CMC Update
4 CMC Update
Slide 31: CMC: World-Class Team, Bioprocessing Platform and Infrastructure
CMC World-Class CMC team, Bioprocessing platform and Infrastructure Deliver High Quality Products with High Speed and Low Cost Experienced Global Team Advanced Bioprocessing Platform High Output and Flexible Plant • Led by industry veterans from • Global leader in continuous • T-BLOC highly flexible
Slide 32: CMC: Strong Execution and Commercial Launch Readiness
CMC World-Class CMC team, Bioprocessing platform and Infrastructure Strong Execution with Increased Efficiency and Commercial Launch Readiness Strong project execution, expanding capacity • Achieved 100% success rate in project Advance Manufacturing Platform to execution in 2021 increase speed, qual
Slide 33: Financial Results & 2022 Outlook
5 Financial Results & 2022 Outlook
Slide 34: Financial Results
Financial Results Healthy financial profile and well capitalized for growth initiatives Cash Balance • RMB 1,222 million of cash, cash equivalents and time deposits as of December 31, 2021 • Revenue: RMB 50.2 million Key Income • Other Income: RMB 32.9 million Statement Metrics • R&D expenses (non-I
Slide 35: Outlook
Outlook Integrated Platform, Cutting-edge Technology, Differentiated and Competitive Biologics Clinical Development • Initiate global phase III trial for TST001 for CLDN18.2 over-expressing GC in 2H22 1 • Interim Data Readout for TST001 in late line GC in Q4/22 and 1st line GC in 1H23 • Advance firs
Slide 36: Thank you!
6 Thank you! Email: ir@transcenta.com