Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — FY2023 Earnings Presentation
38 slides from Cstone Pharmaceuticals's earnings presentation, Mar 28, 2024
Slide 1: 2023 Annual Results Presentation
2023 Annual Results Presentation March 28th, 2024 Stock Code: 2616. HK
Slide 2: Presentation Disclaimer
Presentation Disclaimer • By attending the meeting where this presentation is made, or by reading the presentation materials, you agree to be bound by the following: • The information in this presentation has been prepared by representatives of CStone Pharmaceuticals (the "Company" and, together wit
Slide 3: A fully integrated biopharma with end-to-end capabilities
A fully integrated biopharma with end-to-end capabilities 5.5 years from inception to the first commercial launch RESEARCH DEVELOPMENT COMMERCIAL Clinical insight driven Efficient, high-quality and Full capability of in-house modular R&D model innovative clinical dev. engine commercialization 4* com
Slide 4: Business Achievements
01 Business Achievements 2023 & 2024YTD 4
Slide 5: 2023 and 2024YTD Achievements
2023 and 2024YTD Achievements A full-fledged biopharma with strong growth momentum in 2023 Financial Research & Development and Partnerships as of Dec. 31, 2023 as of Mar. 27, 2024 5 New NDA approvals 2 NDAs currently under review Total revenue [1] in FY2023 1L NSCLC 463.8 Pralsetinib 1L stage IV NS
Slide 6: Pipeline Updates
Pipeline Updates 02 1. Key Clinical Program 2. Innovative Early Programs 3. Commercial-stage Programs 6
Slide 7: To drive business growth by advancing innovative pipeline 2.0
To drive business growth by advancing innovative pipeline 2.0 and maximizing commercial value of mature products Key Clinical Program Innovative Early Programs Commercial-stage in Pipeline 2.0 in Pipeline 2.0 Programs CS2009 Pralsetinib (PD-1/CTLA4/VEGF tri-specific mAb) (RET) CS5001 (ROR1 ADC) CS50
Slide 8: Pipeline Updates
Pipeline Updates 02 1. Key Clinical Program 2. Innovative Early Programs 3. Commercial-stage Programs 8
Slide 9: CS5001 (ROR1 ADC)
CS5001 (ROR1 ADC) Top 2 in position globally with Ph1 study ongoing in US, Australia and China 4 key differentiators support best-in-class potential: An ADC target for both hematological malignancies 2 and solid tumors 3 4 • Largely absent in normal blood lymphocytes and adult tissues 1~3 1 Conjugat
Slide 10: ROR1 is a promising target for multiple malignancies
ROR1 is a promising target for multiple malignancies Receptor tyrosine kinase-like orphan receptor 1 (ROR1) is a member of the receptor tyrosine kinase family Broad expression of ROR1 in both solid tumor and hematological malignancies (e.g., TNBC, lung cancer, ovarian cancer, pancreatic cancer,
Slide 11: CS5001 (ROR1 ADC) preclinical data overview (1/2)
CS5001 (ROR1 ADC) preclinical data overview (1/2) Robust antitumor activities observed in both solid tumors and hematological cancers CS5001 remarkably killed tumor cells in CDX models, superior in vivo efficacy Jeko1 (Mantle cell lymphoma) PA-1 (Ovarian cancer) PBS, IV, QW DS placebo CS5001, 1 mg/k
Slide 12: CS5001 (ROR1 ADC) preclinical data overview (2/2)
CS5001 (ROR1 ADC) preclinical data overview (2/2) Synergistic with checkpoint inhibitors Remarkable bystander effect Proprietary IHC mAb CHO-S & CHO-S-ROR1 coculture developed in house 120 for companion diagnostic CHO-S-ROR1- monoculture 100 CHO-S-ROR1+ monoculture Viability % 80 CHO-S-ROR1- & CHO-S
Slide 13: CS5001 phase 1 trial design and fast-to-market registrational trial plan
CS5001 phase 1 trial design and fast-to-market registrational trial plan A Phase 1, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS5001, an Anti-ROR1 Antibody Drug Conjugate, in Patients with Advanced Solid Tumors and Lym
Slide 14: Phase 1 update: CS5001 well-tolerated with promising anti-tumor activities
Phase 1 update: CS5001 is well-tolerated and has demonstrated promising anti- tumor activities in both solid tumors and hematological malignancies A Escalated to Dose Level 9 (DL9) with no DLT events • DLT evaluation completed at prior 8 dose levels, DL9 currently under evaluation • DLT not observed
Slide 15: CS5001 safety profile (1/2)
CS5001 safety profile (1/2): favorable safety profile of CS5001 vs. two relevant ADCs in phase I trials Lower frequency of hematologic and non-hematologic AEs observed for CS5001 up to Dose Level 8 Hematologic TEAEs Non-hematologic TEAEs (incidence ≥ 25%) (incidence ≥ 25%) 80% 80% 70% 70% 60% 60% 50
Slide 16: CS5001 safety profile (2/2)
CS5001 safety profile (2/2): CS5001 exhibited fewer hematologic toxicities vs. a commercial-stage PBD-based ADC at similar dose levels Hematologic TEAEs by Dose Levels - Loncastuximab Tesirine vs. CS5001 Loncastuximab Tesirine CS5001 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% <=90ug/kg 120ug/kg 150ug/kg
Slide 17: CS5001 case reports of antitumor activities
CS5001 case reports of antitumor activities Patient 0104003 (DL5): 33-year-old male, Patient 0104002 (DL6): 34-year-old female, Patient 0201010 (DL7): 52 y/o female with Stage IV Hodgkin Lymphoma Stage IV Hodgkin Lymphoma advanced pancreatic adenocarcinoma Patient’s disease relapsed following two pr
Slide 18: CS5001 PK profile
CS5001 PK profile: excellent linker stability with dose-proportional exposure CS5001 and Total Antibody Mean Concentration-Time • PK data suggested a dose proportional exposure of CS5001 following i.v. administration • Immunoconjugate exhibited excellent linker stability, with close similarity obser
Slide 19: CS5001 phase 1 clinical program summary
CS5001 phase 1 clinical program summary CS5001, a novel ROR1–directed PBD-ADC, appears well tolerated and safe in the first-in 1 -human phase 1 study • No DLT was observed and MTD was not reached • Lower toxicities were observed comparing to other relevant ADCs CS5001 demonstrated promising antitumo
Slide 20: Pipeline Updates
Pipeline Updates 02 1. Key Clinical Program 2. Innovative Early Programs 3. Commercial-stage Programs 20
Slide 21: Innovative early programs in pipeline 2.0
Innovative early programs in pipeline 2.0: multiple internally developed assets to drive future growth Making rapid progress on multiple projects, seeking partnership opportunities Multiple potential FIC/BIC discovery programs are at/near PCC CS2009 CS5005 CS5006 CS5007 CS2011 PD-1 x CTLA-4 x VEGFa
Slide 22: CS2009 (PD-1, CTLA-4, VEGFa tri-specific antibody)
CS2009 (PD-1, CTLA-4, VEGFa tri-specific antibody) A FIC molecule estimated IND in Q4 2024 Differentiated molecular design Preclinical data A potential FIC tri-specific antibody PD-1xCTLA4 bispecific 1 targeting large indications 3 0 0 0 3000 In the immune-competent 2 5 0 0 2500 model, CS2009 exhibi
Slide 23: CS5005 (GPCR-x ADC)
CS5005 (GPCR-x ADC) A FIC molecule to be IND-ready in 2025 Differentiated molecular design Preclinical data A novel ADC target 221 (parental clone) with FIC potential 221.3.1 221.3.2 183 (parental clone) Molecular design Superb GPCR-x selectivity 183.LZ4 183.HZ4 Selectivity of lead humanized clones
Slide 24: CS5006 (novel-target ADC)
HT29 CS5006 (novel-target ADC) G1 Vehicle (PBS), i.v., 10μL/g, Single dose G2 H86.2-DXD(DAR 8), 10mg/kg, i.v., 10μL/g,Single dose A FIC molecule to be IND-ready in 2025 G3 Isotype-DXD(DAR 8), 10mg/kg, i.v., 10μL/g,Single dose G4 H86.2-DXD(DAR 3.78), 10mg/kg, i.v., 10μL/g,Single dos G5 H86.2-DXD(
Slide 25: Pipeline Updates
Pipeline Updates 02 1. Key Clinical Program 2. Innovative Early Programs 3. Commercial-stage Programs 25
Slide 26: Pralsetinib and ivosidenib: maximize commercial value through partnerships
Pralsetinib and ivosidenib: maximize commercial value through partnerships Leverage the strength of partners in commercialization to maximize the value of commercial pipeline Commercial Collaboration Pralsetinib Nov. 8th, 2023 Ivosidenib Dec. 21st, 2023 RET inhibitor IDH1 inhibitor Granted exclusive
Slide 27: Avapritinib
Avapritinib FIC KIT/PDGFRA inhibitor with potential to expand to indications beyond GIST; partnership negotiation ongoing Development and Regulatory Progress GIST SM ~45K PDGFRA KIT 17/18 Advanced Non-advanced KIT D816 or N822 mutant r/r AML exon 18 mutant (2-4L) annual newly diagnosed patients with
Slide 28: Sugemalimab (PD-L1 mAb)
Sugemalimab (PD-L1 mAb) All 5 indications approved in China; MAA under regulatory review in EU and UK; in active discussion with global partners Regulatory Progress 2021 2022 2023 2024… Stage IV NSCLC R/R ENKTL GC/GEJC CN Stage III NSCLC ESCC Stage IV NSCLC Stage IV NSCLC Approval Potential total UK
Slide 29: CStone's Mature and Innovative Portfolio
CStone’s Mature and Innovative Portfolio Covers a Broad of 5,000K+ Indications with Rapidly Global annual incidence[3] Growing Commercial Value 2,000K+ Global annual incidence[2] ~200K China annual incidence[1] Precision Medicine Immuno-oncology Pipeline 2.0 • Pralsetinib (commercial) • Sugemalimab
Slide 30: Financial Highlights
03 Financial Highlights 30
Slide 31: FY2023 financial results
FY2023 financial results Significantly lower loss for the year from BD income with robust cash reserve Mn RMB FY2023 FY2022 Change GROUP REVENUES 463.8 481.4 -4% Total Group Revenues of RMB 463.8Mn Sales of Pharmaceutical Products [1] 336.7 364.3 -8% • Sales of Pharmaceutical Products -8% to RMB 336
Slide 32: Catalysts
04 Catalysts 32
Slide 33: Expected catalysts in the near term
Expected catalysts in the near term Assets Catalysts Date Ph1 data presentation at 2024 ASCO and ESMO / ASH 1H2024 & 2H 2024 Key clinical CS5001 (ROR1 ADC) Initiation of Ph1b trial with registrational potential 2H2024 program Global BD partnership 2024/2025 CS2009 (PD1xCTLA4xVEGFa) IND submissions 2
Slide 34: Thanks
Thanks 34
Slide 35: Appendix
Appendix 35 [El
Slide 36: Well-balanced oncology portfolio of 12 innovative assets
Well-balanced oncology portfolio of 12 innovative assets Pre- Approval Drug candidate Rights Indication FIH POC Pivotal NDA Marketed Partner clinical CN TW HK US Pipeline 2.0 Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS2009 (PD1/CTLA4/VEGFa) Solid tumors CS5005 (GPCR-x ADC) Solid tumo
Slide 37: Experienced management team
Experienced management team Jason Yang M.D., Ph.D. Chief Executive Officer, President of R&D Michael Choi Qingmei Shi Yujuan La MBA M.D., Ph.D. Ph.D. Chief Business and Strategy Officer Chief Medical Officer Head of Product Dev. Min Liao Nicky Ni Yinghua Zhang EMBA MBA, CFA Head of Commercial Chief
Slide 38: END
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CStone Pharmaceuticals — FY2023 Earnings Presentation on 6ix