Transcenta Holding Limited · HKEX:6628
Transcenta — H1 2023 Earnings Presentation
38 slides from Transcenta's earnings presentation, Aug 23, 2023
Slide 1: 2023 Interim Results Update
Stock Code: 6628.HK 2023 Interim Results Update August 23, 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: Results Highlights, Business Update, Financial & Outlook
Results Highlights 1 Business Update 2 Financial & Outlook 3
Slide 4: 1H23 Results Highlights
Q1 | 1H23 Results Highlights
Slide 5: 2023 Pipeline and Business Focus
2023 Pipeline and Business Focus Focus Osemitamab (TST001) Blosozumab (TST002) TST003 Best-In-Class anti-CLDN18.2 Best-In-Class anti-Sclerostin First-in-Class anti-GREM1 • Conduct key Health Authority • Complete Ph1, initiate Ph2 trial • Expedite Ph1 set-up in US and consultations and initiate globa
Slide 6: Results Highlights
Results Highlights Key Regulatory Approvals Received with Encouraging Data • Presented osemitamab-CAPOX combo data at ASCO 2023 & ESMO-GI 2023: improved PFS and DOR in a broader patient Osemitamab population with CLDN18.2 expression • Completed enrollment of 82 patients in osemitamab-CAPOX-nivolumab
Slide 7: CMC & CDMO
CMC & CDMO Broad Range of CDMO Service Capabilities with Cutting Edge Technology CDMO Revenue (Million RMB) 36.1 Integrated DP Fill & IND project Finish + 65.8% 21.8 ADC Cell Culture Conjugation Media Development 1H 2022 1H 2023 7
Slide 8: Business Update
02 Business Update
Slide 9: Proprietary IMTB Platform and Differentiated Antibodies
Proprietary IMTB Platform and Differentiated Antibodies Our Proprietary Antibody Discovery Platform : IMTB Delivers Differentiated Lead Candidates mAb Osemitamab (TST001) (BIC) CLDN18.2 TST003 (FIC) Gremlin1 IMTB Platform TST004 (BIC) MASP2 Target protein Bi-specific TST005 (BIC) PDL1-TGF-β TST008 (
Slide 10: Pipeline Highlights
Pipeline Highlights 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 Global Combo with Nivolumab/Chemo Osemitamab G/GEJC 1L China Combo with Chemo Claudin 18.2 Globa
Slide 11: Osemitamab (TST001)
Osemitamab (TST001)
Slide 12: Evolving Landscape for 1L Gastric Cancer
Osemitamab (TST001) Evolving Landscape for 1L Gastric Cancer 1994 2008 2010 2021 2024 Future Trastuzumab/ 5FU Oxaliplatin Trastuzumab Pembrolizumab HER2-positive HER2-positive Osemitamab/ Nivolumab Zolbetuximab PD1 HER2-negative CLDN18.2-positive CLDN18.2-positive 12 Scheithauer et al Ann Hematol 19
Slide 13: The 2nd Leading Anti-CLDN18.2 mAb with a Differentiated Profile vs. Zolbetuximab
Osemitamab (TST001) Oncology The 2nd Leading Anti-CLDN18.2 mAb with a Differentiated Profile vs. Zolbetuximab BIC / FIC Potentials Significantly better than Zolbetuximab MKN45-CLDN18.2 (40%) BxPC3-CLDN18.2 (90%) Gastric Tumor Model PDAC Tumor Model Humanized Higher binding Enhanced 1200 2000 Tumor V
Slide 14: Osemitamab (TST001) Development Status
Osemitamab (TST001) Development Status: Solid data package supporting Ph3 plans in 1L G/GEJC In the U.S. and China >300 patients dosed as of June 30, 2023 including >150 1L G/GEJC across a broad range of CLDN18.2 expression. Key cohorts below. TranStar102/TST001-1002 (CN) - NCT04495296 TranStar101/T
Slide 15: Osemitamab (TST001) Milestones in 2023
Osemitamab (TST001) Milestones in 2023 Jul Jun • Positive CDE consultation for Ph3 plans • ASCO 2023 Apr • Received Safe to proceed for Ph3 • ESMO GI 2023 study from CDE and South Korea Mar • Completed the • Updated MFDS Jan enrollments of supportive data • In discussions with multiple regulatory •
Slide 16: Encouraging Efficacy Outcomes-Cohort C-1L G/GEJC with CAPOX
Osemitamab (TST001) Encouraging Efficacy Outcomes-Cohort C-1L G/GEJC in combination with CAPOX Estimated mPFS of 9.5m in patients with CLDN18.2 expression ≥10% Key Messages and ≥1+* - all doses of Osemitamab 55% screened patients enrolled based on their CLDN18.2 expression, with Transcenta proprieta
Slide 17: Osemitamab Clinical Differentiation
Osemitamab (TST001) Osemitamab (TST001）-Clinical Differentiation Claudin 18.2 Prevalence mPFS mDOR Cutoff (% of all G/GEJC cases) Osemitamab +CAPOX* ≥10%, ≥1+ 55% 9.5m 9.9m (n=64, all doses) Zolbetuximab +CAPOX** ≥75%, ≥2+ 38% 8.21m 6.3m (N=254) CAPOX** ≥75%, ≥2+ 38% 6.8m 6.2m (n=249) Cross study co
Slide 18: Synergy Between TST001 and Nivolumab
Osemitamab (TST001) Synergy Demonstrated between Targeted Therapy TST001 and Checkpoint Inhibitor Nivolumab TST001 Induces Upregulation of PDL1 Key Messages BIC potential: Enhanced ADCC modality and synergy with PDL1 supportive of development in a broader CLDN18.2+ CLDN18.2 (100%)/PDL1+ Syngeneic Mo
Slide 19: Study Design - Cohort G and Cohort A
Osemitamab (TST001) Study Design - Cohort G and Cohort A -1L G/GEJC in combination with CAPOX plus PD-L1 Study Design Status Key Messages TranStar102/NCT04495296 Recruitment completed TST001 + Nivolumab + CAPOX – 1L G/GEJ cancer in April 2023: Cohort G TST001 6mg/kg + Nivolumab + CAPOX Q3W N=3-6 TST
Slide 20: Ph3 global MRCT trial design & status
Osemitamab (TST001) Ph3 global MRCT trial design & status Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma TST001 + CapOx or mFOLFOX6 + Nivolumab 1L treatment CLDN18.2 positive Placebo + CapOx or mFOLFOX6 + Nivolumab Status HER2 negative • Operationally on t
Slide 21: Osemitamab (TST001) Indication Potential
Osemitamab (TST001) Indication Potential Development plan and huge potential for multiple indications enabled by Transcenta specific IHC CDx Assay. 1L GC/GEJC Other indications Peri-Operative GC 1L PDAC Lung Cancer >100K ~70K ~75K ~41K addressable patients globally addressable patients globally addr
Slide 22: Blosozumab (TST002)
Blosozumab (TST002)
Slide 23: Blosozumab (TST002) Landscape
Blosozumab (TST002) Landscape High Unmet Medical Needs Large Market Potential Key Messages The lifetime risk Market size of China anti-sclerostin drugs of osteoporotic (USD bn) Total patient[1] fracture in women is ~90 ~40% CAGR: 2022E-2035E 4.4 Key Drivers and million +39.2% Future trends • Fast gr
Slide 24: A Well Differentiated Monoclonal Antibody Targeting Sclerostin
Blosozumab (TST002) A Well Differentiated Monoclonal Antibody Targeting Sclerostin for Bone Diseases, Licensed from Eli Lilly Dual Mechanisms Favorable Background Bone mass • Ph2 study in US/JAPAN completed by Eli LIlly • Outstanding BMD increase with 52 weeks treatment: 17.7% in lumbar spine, 6.7%
Slide 25: Ph1 single ascending dose confirms efficacy and longer dosing interval
Blosozumab (TST002) Ph1 single ascending dose confirms significant efficacy and potential for longer dosing interval D85 lumbar spine BMD % change from baseline in TST002 Pharmacokinetic profile Key Messages Semi-logarithmic scale 7.00% 6.20% 5.94% 6.00% • Efficacy and clinical 5.00% 4.49% pharmacol
Slide 26: Blosozumab (TST002) Indication Potential
Blosozumab (TST002) Indication Potential Huge unmet medical needs and broad target patient populations for anti-sclerostin antibody No anti-sclerostin drug has been approved in China yet Postmenopausal Osteoporosis in Men Post OVCF* Surgery Osteoporosis in Women ~70 million 20 million 1.5 million pa
Slide 27: TST003
TST003
Slide 28: First-In-Class anti-GREMLIN-1 mAb with Potentials in Multiple Tumor Types
TST003 First-In-Class anti-GREMLIN-1 mAb with Potentials in Multiple Tumor Types • Gremlin-1 is an antagonist of BMP signaling pathway Key Messages • Gremlin-1 may have multiple functions to promote tumor progression and metastasis Target and • Gremlin-1 is highly upregulated in multiple types of so
Slide 29: TST003 displayed potent anti-tumor activity in MSS CRC PDX model
TST003 displayed potent anti-tumor activity in MSS CRC PDX model Grem1 TST003 • Grem1 is highly upregulated in • TST003 enhanced BMP signaling and inhibited Wnt signaling (RNseq) advanced MSS CRC • TST003 facilitates infiltration of CD3/CD8 T cells into tumor (IHC) • TST003 displayed promising activ
Slide 30: TST003 displayed potent anti-tumor activity in mouse model of mCRPC
TST003 displayed potent anti-tumor activity in mouse model of mCRPC Grem1 TST003 • Grem1 is highly upregulated in • TST003 displayed potent single agent anti-tumor activity in mouse model of AR low or mCRPC negative • TST003 treatment can restore AR sensitivity and be synergistic with AR antagonist
Slide 31: TST003 Indication Potential
TST003 Indication Potential Development plan: major indications with unmet medical need and substantial market size will be explored MSS CRC in CRPC in combination Address unmet medical combination with SOC with AR inhibitors needs in other indications >~285K >~100K Supported by preclinical addressa
Slide 32: Upcoming milestones
Upcoming milestones Q3/23 Q4/23 1H/24 Osemitamab (TST001) Osemitamab (TST001) Osemitamab (TST001) • FDA EOP2 meeting • Presentation of updated • Data readout for cohort-G • First patient dosing of PFS and preliminary OS (osemitamab/Nivo/Chemo Ph3 TranStar-301 data of combo Ph2 trial) osemitamab (TST
Slide 33: CMC & CDMO
CMC & CDMO Flawless Execution, Increased Efficiency, Global Quality Standard and Commercial Manufacturing Readiness Developed Specialized CDMO Services ADC CMC Medium Drug product process development development development Enhanced Pipeline Development Upgraded Platform Technology • Completed proce
Slide 34: Business Development
Business Development Multinational Partners to Maximize Value Commercialization Clinical Trial Collaboration Strategic cooperation agreement with “Tofflon”(Stock Code: SZ 300171) for the market development and sales of the medium. TST001 Joint Venture In-License TST004 TST002 Technology-based Partne
Slide 35: Financial & Outlook
03 | Financial & Outlook
Slide 36: 1H2023 Financial Results
1H2023 Financial Results Financial Profile Key Income Statement Metrics (Non-IFRS) Revenue Other Income 36.1 + 65.8% RMB 36.1 million 23.9 17.6 21.8 RMB 17.6 million - 26.3% 1H 2022 1H 2023 1H 2022 1H 2023 R&D expenses Administrative expenses 57.4 RMB 48.7 million 203.9 RMB 203.9 million 165.8 -15.2
Slide 37: Outlook
Outlook Integrated Platform, Cutting-edge Technology, Differentiated and Competitive Biologics Clinical Development CMC & CDMO • Present data for Osemitamab • Develop and grow CDMO (TST001) business • Initiate global Ph3 trial for • Expand service scope Osemitamab (TST001) in 2023 • Enhance Platform
Slide 38: Thank You!
G TRANSCENTA INNOVATE TO EXCEL THANK YOU!