Transcenta Holding Limited · HKEX:6628
Transcenta — H1 2024 Earnings Presentation
29 slides from Transcenta's earnings presentation, Aug 29, 2024
Slide 1: 2024 Interim Results Update
Stock Code: 6628.HK 2024 Interim Results Update August 29, 2024
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: Key Highlights
Key Highlights
Slide 4: Key Highlights
Key Highlights Pipeline Progress and Data Presentations CLDN18.2 (BIC) Osemitamab (TST001) • Presented TranStar-101 data at AACR 2024 • Presented Cohort-G PFS data at ASCO 2024 • Announced collaboration with Agilent to develop companion diagnostic Sclerostin (BIC) Blosozumab (TST002) • Published SAD
Slide 5: Pipeline Overview
Pipeline Overview Diversified and Differentiated Pipeline Drug Clinical trial Pivotal Target Indications Preclinical IND Phase 1 Phase 2 Rights Partner candidate region Phase 3 G/GEJC 1L Global Combo with PD1/Chemo Osemitamab Claudin18.2 G/GEJC 1L Global Combo with Chemo Global In-house (TST001) PDA
Slide 6: Transcenta Global Strategy and Integrated Capabilities
Transcenta Global Strategy and Integrated Capabilities • Build internal expertise in developing innovative antibody-based therapies in oncology • Leverage external resources for non-oncology programs Lead Industry Leading Antibody Generation Discovery and Bio-processing Translational Platforms Resea
Slide 7: New Molecular Entities Derived from Proprietary IMTB Platform
New Molecular Entities (NME) Derived from Proprietary TST012 IMTB Platform GC etc., ADC Phase 3 TST003 TST013 Solid Tumors BC etc., Phase 1 or 2 Osemitamab MSB0254 TST001 Solid Tumors Preclinical G/GEJC PDAC TST008 SLE/LN/IgAN etc., TST005 Solid Tumors TST004 IgAN, TMA etc., BsAb TST801 mAb SLE/LN/I
Slide 8: Business Update
Business Update
Slide 9: Osemitamab (TST001): A Best-in-class Anti-CLDN18.2 Antibody
Osemitamab (TST001) A Best-in-class Anti-CLDN18.2 Antibody BIC Profile Global Phase 3 Ready Asset • Improved antibody with • China and US extensive dataset increased potential to target • Dose optimization complete medium/low CLDN18.2 • Approval from key regulatory expressors authorities • Promising
Slide 10: Osemitamab vs Zolbetuximab Differentiated Profile
Osemitamab (TST001) The BIC Anti-CLDN18.2 mAb with a Differentiated Profile vs. Zolbetuximab Significantly Better than Zolbetuximab Mean Fluorescence Intensity 80,000 TST001 Higher binding 60,000 IMAB362-analog Isotype control affinity 40,000 enhanced 20,000 ADCC* 0 -4 -3 -2 -1 0 1 2 3 -5 0 10 10 10
Slide 11: Stronger Anti-tumor Activity vs Zolbetuximab
Osemitamab (TST001) Stronger Anti-tumor Activity VS Zolbetuximab for CLDN18.2 Expressing Gastric Cancer Cells with Potential for Multiple Tumor Types Strong anti-tumor activities in several CLDN18.2 positive tumor models CLDN18.2 positive gastric cancer tumor model CLDN18.2 positive pancreatic cance
Slide 12: Phase 1/2 Trial Overview - Study Design
Osemitamab (TST001) Phase 1/2 Trial Overview - Study Design: Key G/GEJC Cohorts for First-line G/GEJC Regimen CLDN18.2 Level Status • Complete Cohort G: TST001 Q3W + CAPOX + All comers • 82 Patients enrolled across 2 dose levels Checkpoint inhibitor • Updated data presented at ASCO 2024 TranStar102
Slide 13: Encouraging Data from First-line Triple Combo Trial
Osemitamab (TST001) Demonstrated Encouraging Data from First-line Triple Combo Trial for G/GEJ Cancer Efficacy results confirm predictive value of CLDN18.2. median PFS 12.6 months in H/M group Progression-Free Survival of Cohort G by CLDN18.2 Level, Objective Response Rate any PD-L1 CPS (CLDN18.2, P
Slide 14: Comparative Efficacy to Benchmark – Cross Study Comparisons
Osemitamab (TST001) Comparative Efficacy to Benchmark – Cross Study Comparisons H/M Group Compared to Nivolumab+Chemo Data in H/M Group Compared to Zolbetuximab+Chemo Data in GLOW** Checkmate649* mPFS[1] mPFS[1] 15 15 Osemitamab CLDN18.2 10 12.6 10 12.6 7.7 8.2 5 6.9 5 6.8 0 0 Chemo Chemo+Nivolumab
Slide 15: Development Plan and Huge Potential for Multiple Indications
Osemitamab (TST001) Development Plan and Huge Potential for Multiple Indications Combo with SOC (Checkpoint Inhibitor / Chemotherapy) First-line G/GEJC >100K addressable patients globally * [1] Potentially First Mover Anti-CLDN18.2 mAb Peri-Operative GC ~70K addressable patients globally * [2] First
Slide 16: Anti-sclerostin mAbs Address Unmet Needs of Osteoporosis in China
Blosozumab (TST002) Anti-sclerostin mAbs are Poised to Address the Huge Unmet Needs of Osteoporosis in China High Unmet Medical Needs with Large Market Potential Rising incidence of OP fractures in China Rising market size of anti-sclerostin drugs Aging population in China due to aging population&ur
Slide 17: Blosozumab (TST002): A Well Differentiated Anti-Sclerostin Antibody
Blosozumab (TST002) A Well Differentiated Anti-Sclerostin Antibody Targeting Sclerostin for Bone Disorders Favorable Background Dual Mechanisms ✓ Phase 2 study in US/JAPAN completed by Eli Lilly Bone mass ✓ Significant BMD increase with 52 weeks treatment: 17.7% in lumbar spine, 6.7% in total hip an
Slide 18: Blosozumab (TST002): SAD Study Design
Blosozumab (TST002) TST002-1001, SAD Study Design • 32 subjects have been enrolled. Study population: 1200mg，n=6+2 Endpoint • Subjects with • Safety and tolerance reduced BMD(- 3.5≤ T value<-1.0) 800mg，n=6+2 • PK • Age 45-70yrs • PD: total sclerostin, bone turnover • Postmenopausal 400mg，n=6+2 bioma
Slide 19: Encouraging Phase Efficacy Data Justifying Further Development
Blosozumab (TST002) Encouraging Phase 1 Efficacy Data Justifying Further Clinical Development • Comparable results on BMD and bone turnover markers with that in Blosozumab SAD study. • No new safety signal found. Presented TST002 SAD Study Result in the 2024 WCO-IOF-ESCEO Congress D85 lumbar spine B
Slide 20: Huge Unmet Medical Needs and Broad Target Patient Populations
Blosozumab (TST002) Huge Unmet Medical Needs and Broad Target Patient Populations for Anti-sclerostin Antibody Postmenopausal Osteoporosis ~70 million patients in China[1] in Women ~3 million osteoporotic fractures in China Osteoporosis in Men ~20 million patients in China[1] Post OVCF* Surgery ~1.5
Slide 21: TST003: A Novel Target for Multiple Solid Tumor Indications
TST003 A Novel Target with Potential for Multiple Solid Tumor Indications Tumors enriched with stromal cells are less responsive to immunotherapy Gremlin-1 is an antagonist of BMP signaling pathway MSS CRC mCRPC TST003+/-VEGFRi TST003 +/-ARi 1400 with hPBMCs Gremlin-1 is highly upregulated in multip
Slide 22: Upcoming Milestones
Upcoming Milestones 2H 2024 Osemitamab (TST001) Blosozumab (TST002) TST003 BIC BIC FIC A Humanized ADCC Enhanced Anti- A Humanized Sclerostin mAb for A First-in-Class Humanized Anti- CLDN18.2 mAb for Solid Tumors Osteoporosis Gremlin-1 Antibody Osemitamab CLDN18.2 • Advance global pivotal trial for
Slide 23: Emerging Pipeline of Oncology & Autoimmune Drug Candidates
Emerging Pipeline of Oncology & Autoimmune Drug Candidates TST012 TST013 • ADC product candidate • ADC product candidate ADC Product • For gastric cancer, lung cancer etc. • For breast cancer and other solid tumors Candidate • Lead antibody, lead molecule selected • Lead antibody selected and IND en
Slide 24: CMC & CDMO
CMC & CDMO Flawless Execution, Increased Efficiency, Global Quality Standard World Class CMC Team, Bioprocessing Platform and Infrastructure Faster Quality Significant Cost Saving Leading Perfusion Technology Advanced Technology and Platform High Quality Output • Implemented intensified perfusion ba
Slide 25: Business Development
Business Development Multinational Partners to Maximize Value Clinical Trial Research In-License Collaboration Collaboration • Collaborating the clinical trial and • In-licensed Greater China rights (with • Several research collaborations have been completing the enrollment in TranStar102 ROFN for g
Slide 26: Financial & Outlook
Financial & Outlook
Slide 27: 2024 1H Financial Results (Non-IFRS)
2024 1H Financial Results (Non-IFRS) Revenue Other Income RMB 4.6 million RMB 9.6 million 36.1 -87.3% - 45.5% 17.6 9.6 4.6 2023 1H 2024 1H 2023 1H 2024 1H R&D Expenses SG&A Expenses RMB 95.5 million RMB 26.1 million - 53.2% 203.9 48.7 - 46.4% 95.5 26.1 2023 1H 2024 1H 2023 1H 2024 1H Bank deposits a
Slide 28: Outlook
Outlook Integrated Platform, Cutting-edge Technology, Differentiated and Competitive Biologics Research Clinical Development CMC & CDMO Business Development • Expand • Present • Develop and Grow • Continue partnership pipeline by designing new data for osemitamab CDMO business discussions with multi
Slide 29: Thank You
Z TRANSCENTA INNOVATE TO EXCEL THANK YOU! Z Gi C4 CU RESE ~@ TRANSCENTA