Transcenta Holding Limited · HKEX:6628
Transcenta — FY2023 Earnings Presentation
34 slides from Transcenta's earnings presentation, Mar 28, 2024
Slide 1: 2023 Annual Results Update
Stock Code: 6628.HK 2023 Annual Results Update March 28, 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 TRANSCENTA
Slide 4: Key Highlights
Key Highlights Significant Progress with Key Regulatory Interactions and Datasets Presentations Osemitamab (TST001) Blosozumab (TST002) • Presented data at several major • Completed Ph1 single dose escalation congresses • Observed significant BMD increases • Completed enrollment in key cohorts • Obt
Slide 5: Proprietary IMTB Platform and Differentiated Antibodies
Proprietary IMTB Platform and Differentiated Antibodies Our Proprietary Antibody Discovery Platform • Osemitamab (TST001) (BIC) CLDN18.2 mAb • TST003 (FIC) Gremlin1 • TST004 (BIC) MASP2 • TST005 (BIC) PDL1-TGF-β • TST008 (FIC) MASP2/BAFF Target protein Bi-specific • TST006 PDL1-CLDN8.2 • TST801(FIC)
Slide 6: Pipeline Overview
Pipeline Overview Diversified and Differentiated Pipeline Drug Target Indications IND Phase 1 Phase 2 Phase3 Rights Partner candidate 1L G/GEJC Combo with Nivolumab/Chemo Global In-house Osemitamab Claudin 18.2 (TST001) 1L PDAC Combo with Chemo Global In-house Blosozumab Mono US Ph II Sclerostin Ost
Slide 7: Business Update
Business Update TRANSCENTA
Slide 8: Osemitamab (TST001)
Osemitamab (TST001) A Humanized ADCC-enhanced anti-Claudin 18.2 mAb for Solid Tumors 8
Slide 9: Osemitamab: BIC anti-CLDN18.2 mAb with Potential of Leading New Paradigm
Osemitamab (TST001) A BIC anti-CLDN18.2 mAb with the Potential of Leading a New Treatment Paradigm in G/GEJ Cancer Target patient number 2023 >300K Worldwide [2] [1] Claudin18.2 TST001 Cornerstone for the treatment of CLDN18.2 positive solid tumors Note 1: 1L HER2-negative/CLDN18.2 positive mG/GEJC
Slide 10: Differentiation vs. Zolbetuximab
Osemitamab (TST001) Differentiation vs. Zolbetuximab Higher Affinity More Potent Osemitamab Longer mDOR/mPFS A Best-in-class Broader Population anti-CLDN18.2 Antibody Better CDx Robust CMC Note: G/GEJC = Gastric or gastroesophageal junction cancer 10 *just in 1L G/GEJC
Slide 11: Program Milestones in 2023
Osemitamab (TST001) Program Milestones in 2023 Q1 Q2 Q3 Q4 January April July December • FDA EOP1 meeting • Enrollment completed in • Clearance to proceed to Ph3 • Preclinical results of cohort C and G, supportive from CDE & MFDS [177Lu]Lu-TST001 published of Ph3 plans on EJNMMI • Ph1/2 design of Ju
Slide 12: BIC Anti-CLDN18.2 mAb with a Differentiated Profile vs. Zolbetuximab
Osemitamab (TST001) The BIC Anti-CLDN18.2 mAb with a Differentiated Profile vs. Zolbetuximab Better anti-tumor activities in CLDN18.2 Strong anti-tumor activities in CLDN18.2 positive gastric cancer tumor model positive pancreatic cancer tumor model (MKN45-CLDN18.2 (40%)) (BxPC3-CLDN18.2 (90%)) 1200
Slide 13: TST001 Ph1/2 Trial Overview - Study Design: Key G/GEJC Cohorts
Osemitamab (TST001) TST001 Ph1/2 Trial Overview - Study Design: Key G/GEJC Cohorts Regimen Setting CLDN18.2 Level # Subjects enrolled Status (as of Feb 2024) TST001 Q3W + 1L G/GEJC ≥ 10%, ≥1+ 64 Updated data Cohort C CAPOX presented at ESMO 2023 TST001-002 (NCT04495296) TST001 Q3W + 1L G/GEJC All co
Slide 14: Promising Efficacy Data of TST001 Chemotherapy Combo in 1L CLDN18.2 G/GEJC
Osemitamab (TST001) Promising Efficacy Data of TST001 Chemotherapy Combo in 1L CLDN18.2 G/GEJC We have TranStar301 Ph3 Applicable CLDN18.2 mPFS cORR mDOR mOS Trial Consultations with: population Osemitamab (TST001) ≥10% & ≥1+ 55% 14.0m 54.8% 12.7m NA +CAPOX* (N=49) (by 14G11 LDT) FDA Cross study com
Slide 15: TST001 plus Nivolumab plus Chemo Could Lead Treatment Paradigm in 1L G/GEJC
Osemitamab (TST001) TST001 in Combination with Nivolumab plus Chemo could Lead the Treatment Paradigm in 1L G/GEJC 2028 and 2021-2024 2025-2027 beyond 1L 1L 1L A New • • Chemo • Zolbetuximab • TST001+ PD1 + chemo Zolbetuximab + Standard of Care + chemo • PD1+chemo • PD1+chemo • chemo PD1+chemo Treat
Slide 16: Development Plan and Huge Potential for Multiple Indications
Osemitamab (TST001) Development Plan and Huge Potential for Multiple Indications 1L GC/GEJC Peri-Operative GC Other tumor types Combo with SOC Potentially first mover 1L PDAC (Nivolumab / chemotherapy) anti-CLDN18.2 mAb ~50% of all comers ** ≥55% of all comers ** ~55% of all comers ** ~75K addressab
Slide 17: Preclinical POC Study of 177Lu-CLDN18.2 RDC
Osemitamab (TST001) Promising Preclinical POC Study of 177Lu-CLDN18.2 RDC, a Novel Approach for Targeting CLDN18.2 Positive Tumor European Journal of Nuclear Medicine and Molecular Imaging https://doi.org/10.1007/s00259-023-06561-1 17
Slide 18: Blosozumab (TST002)
Blosozumab (TST002) A Humanized Sclerostin mAb for Osteoporosis 18
Slide 19: Anti-sclerostin mAbs Poised to 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 Market size of China anti-sclerostin drugs (USD bn) 4.4 +39.2% Total patient[1] Total case of fracture The lifetime risk of The lifetime r
Slide 20: A Well Differentiated Anti-Sclerostin Antibody
Blosozumab (TST002) A Well Differentiated Anti-Sclerostin Antibody Targeting Sclerostin for Bone Disorders Our Objectives Dual Mechanisms Bone mass Bone Resorption Bone Formation OSTEOCLASTS OSTEOBLASTS More Higher More convenient efficacy accessible Favorable Background More potent than all current
Slide 21: Encouraging Ph1 Efficacy Data Justifying Further Clinical Development
Blosozumab (TST002) Encouraging Ph1 Efficacy Data Justifying Further Clinical Development • Finished the Ph1 study with the results to support further research • Received CDE approval to initiate Ph2 trial • Ph1 study abstract has been submitted to 2024 WCO-IOF-ESCEO Congress D85 lumbar spine BMD %
Slide 22: 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 Post OVCF* Osteoporosis in Men Surgery in Women ~70 million 20 million 1.5 million patients in China[1] patients in China[1] new vertebral fracture case in 2020
Slide 23: TST003 (Anti-Gremlin1)
TST003 (Anti-Gremlin1) A First-in-Class Humanized Anti-GREMLIN-1 Antibody 23
Slide 24: TST003 Target and Potential
TST003 Target and Potential Tumors enriched with stromal cells are less responsive Gremlin-1 is an antagonist of BMP signaling pathway to immunotherapy A Epithelial tumors B Mesenchymal tumors Gremlin-1 is highly upregulated in multiple solid tumor types and promote tumor growth and metastasis Tumor
Slide 25: TST003 Potent Anti-tumor Activity in MSS CRC PDX and mCRPC Models
TST003 TST003 Displayed Potent Anti-tumor Activity in MSS CRC PDX Model and Mouse Model of mCRPC • Displayed promising activity in MSS CRC either as single agent or in combination with angiogenic inhibitor • Displayed potent single agent anti-tumor activity in mouse model of AR low or negative MSS C
Slide 26: Major Indications with Unmet Medical Need Will be Explored
TST003 Major Indications with Unmet Medical Need and Substantial Market Size will be Explored MSS CRC in combination with CRPC in combination with AR Address unmet medical SOC inhibitors needs in other tumor types Supported by preclinical data: e.g. NSCLC and SCLC >~285K >~100K 50% NSCLC and address
Slide 27: Upcoming Milestones
Upcoming Milestones 1H 2024 Osemitamab • Advance global pivotal trial for 1L G/GEJ cancer (TST001) • Present data from ongoing Ph2 trials Blosozumab • Present Ph1 SAD study data at a medical conference (TST002) • Initiate dose-ranging Ph2 study • Complete the dose-escalation part of TST003 FIH trial
Slide 28: Emerging Pipeline of Oncology & Auto-Immune Drug Candidates
Emerging Pipeline of Oncology & Auto-Immune Drug Candidates TST012 TST801 • ADC product candidate for • First-in-class bifunctional gastric cancer, lung cancer etc. TST013 TST008 antibody targeting receptors • Lead antibody selected involved in regulating B cell • ADC product candidate for • First-i
Slide 29: CMC & CDMO
CMC & CDMO Leader in Integrated Continuous Biomanufacturing platform (HiCB) CMC & CDMO Flawless Execution, Increased Efficiency, Global Quality Standard and Commercial Manufacturing Readiness Faster Quality Significant cost Leading perfusion saving technology Enhanced Pipeline Development Grew CDMO
Slide 30: Business Development
Business Development Clinical Trial Collaboration Technology-based Partnership Osemitamab (TST001) In-License Multinational Joint Venture Partners to Maximize Value Blosozumab (TST002) TST004 Research Collaboration Commercialization 30
Slide 31: Financial & Outlook
Financial & Outlook TRANSCENTA
Slide 32: 2023 Financial Results
2023 Financial Results Financial Profile Key Income Statement Metrics (Non-IFRS) Revenue Other Income RMB 53.8 million RMB 37.3 million 101.9（22.6%） - 47.2% 46.4 - 19.6% 53.8（26.7%） 37.3 2022 2023 2022 2023 R&D expenses SG&A expenses RMB 372.5million 340.5 372.5 RMB 98.6 million 104.9 98.6 + 9.4% -
Slide 33: Outlook
Outlook Integrated Platform, Cutting-edge Technology, Differentiated and Competitive Biologics Clinical Development CMC & CDMO • Present • Develop and grow Ph2 data for Osemitamab CDMO business (TST001)/Nivolumab/Chemo combo • Enhance • Advance Platform Technology and global Ph3 trial for Osemitamab
Slide 34: TRANSCENTA
TRANSCENTA TRANSCENTA