Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — Investor Presentation (November 2024)
44 slides from Cstone Pharmaceuticals's investor presentation, November 2024
Slide 1: CStone Corporate Introduction
CStone Corporate Introduction November 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 Leverage the strength of modular R&D model innovative clinical dev. engine partners in commercializati
Slide 4: Business Achievements
01 Business Achievements 2024YTD 4
Slide 5: 2024YTD Achievements
2024YTD Achievements Financial Research & Development as of Jun. 30, 2024 as of Oct. 31, 2024 3 New NDA approvals Total revenue [1] in 2024 H1 1L GC/GEJC 5 Data publications / presentations 254.2 Sugemalimab 1L stage IV NSCLC RMB Mn 1L stage IV NSCLC 10+ Preclinical development projects in progress
Slide 6: Pipeline Updates
Pipeline Updates 02 1. Commercial-stage Programs 2. Key Clinical Program – CS5001 & CS2009 3. Innovative Early Programs 6
Slide 7: Maximizing commercial value of products and advancing innovative pipeline 2.0
To drive business growth by maximizing commercial value of products in the market and advancing innovative pipeline 2.0 Commercial-stage Key Clinical Program Innovative Early Programs Programs in Pipeline 2.0 in Pipeline 2.0 CS2011 CS5007 (EGFR/HER3 (EGFR/HER3 bispecific mAb) bispecific ADC) Sugemal
Slide 8: Pipeline Updates
Pipeline Updates 02 1. Commercial-stage Programs 2. Key Clinical Program – CS5001 & CS2009 3. Innovative Early Programs 8
Slide 9: Sugemalimab (anti-PD-L1 mAb) (1/4)
Sugemalimab Sugemalimab (anti-PD-L1 mAb) (1/4) All 5 indications approved in mainland China; 1L NSCLC approved in EU and UK; in active discussions 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 EC a
Slide 10: Sugemalimab (anti-PD-L1 mAb) (2/4)
Sugemalimab Sugemalimab (anti-PD-L1 mAb) (2/4) Approvals obtained in both EU & UK; first global partnership achieved and more to come in 2024 H2 MAA approval achieved in EU & UK, positioning CStone as one of the Global partnerships to bring significant financial impact via immediate few Chinese biot
Slide 11: Sugemalimab (anti-PD-L1 mAb) (3/4)
Sugemalimab Sugemalimab (anti-PD-L1 mAb) (3/4) Sugemalimab demonstrated comparable efficacy with more favorable safety profile vs. pembrolizumab1 Sugemalimab vs. Pembrolizumab in Stage IV NSCLC PD-1/L1+chemo chemo OS 25 22 (month) 17 11 17 12 Overall Non-squamous Squamous Hazard Ratio 0.65 0.56 0.71
Slide 12: Sugemalimab (anti-PD-L1 mAb) (4/4)
Sugemalimab Sugemalimab (anti-PD-L1 mAb) (4/4) Solid clinical data supported EU approval and attracted top-tier partners for commercial opportunities Comments received from partners re: Sugemalimab vs. Pembrolizumab: survival rate in Stage IV NSCLC after 4y follow-up1 ESMO data PD-1/L1+chemo chemo O
Slide 13: Maximize commercial value through partnerships: pralsetinib and avapritinib
Pralsetinib & avapritinib Maximize commercial value through partnerships: pralsetinib and avapritinib Leverage the strength of partners in commercialization to maximize the value of commercial pipeline Commercialization Progress Pralsetinib Nov. 8, 2023 Avapritinib Jul. 3, 2024 RET inhibitor KIT/PDG
Slide 14: Pipeline Updates
Pipeline Updates 02 1. Commercial-stage Programs 2. Key Clinical Program – CS5001 3. Innovative Early Programs 14
Slide 15: Pipeline 2.0: an innovative portfolio with global rights
Well-balanced portfolio of 18 innovative assets – Pipeline 2.0: an innovative portfolio with global rights Preclinical Drug candidate Right Indication Discovery IND FIH POC Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS2009 (PD-1xCTLA4xVEGFa trispecific antibody) Solid tumor
Slide 16: CS5001 (ROR1 ADC)
CS5001 (ROR1 ADC) Top 2 in position globally with phase I study ongoing in US, Australia and China 4 key differentiators support best-in-class potential: An ADC target for both hematological malignancies and solid tumors • Largely absent in normal blood lymphocytes and adult tissues 1~3 • Embryotic
Slide 17: Novel prodrug technology minimizes systematic toxicity of conventional PBD
Novel prodrug technology minimizes systematic toxicity of conventional PBD • PBD prodrug is inactive compared to naked PBD • Prodrug, being in a highly polar form, cannot penetrate and kill normal cells • Prodrug mitigates toxicity risk associated with systemic exposure of conventional PBD payloads
Slide 18: CS5001 phase I trial design and registrational trial plan
CS5001 phase I trial design and fast-to-market registrational trial plan A phase I, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of CS5001 in patients with advanced solid tumors and lymphomas Phase Ia – Monotherapy Dose Esca
Slide 19: CS5001 safety profile
Safety Efficacy PK CS5001 safety profile: Well tolerated in heavily pre-treated patients; Most TRAEs of grade Most Common TEAEs (≥10%) and TRAEs (≥2%) (Safety Analysis Set) 60 (89.6%) patients experienced at least one TEAE; 32 (47.8%) patients had ≥ grade 3 TEAEs. • Most common (≥20%) TEAEs were ana
Slide 20: CS5001 efficacy profile (1/2): 50+% ORR in multiple types of lymphoma
Safety Efficacy PK CS5001 efficacy profile (1/2): 50+% ORR in multiple types of lymphoma Objective responses also observed in other B-cell lymphomas, e.g. Mantal Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), etc. Best overall response (BOR) in Evaluable Patients with Lymphomas DL1-4 DL5 DL6 DL7
Slide 21: CS5001 efficacy profile (2/2)
Safety Efficacy PK CS5001 efficacy profile (2/2): PRs and SDs with reduced tumor burden emerging in various types of solid tumors at higher doses Best overall response (BOR) in Evaluable Patients with Solid Tumors DL1-4 DL5 DL6 DL7 DL8 DL9 All DLs PRs and SDs with reduced tumor burden BOR 7-33.5 µg/
Slide 22: CS5001 PK profile
Safety Efficacy PK CS5001 PK profile: Excellent linker stability with dose-proportional exposure Mean Serum Concentration of CS5001 and Total Antibody Mean Serum Concentration of CS5001 vs. Time Profiles at vs. Time Profiles at Cycle 1 (Semi-Log Scale) Cycle 1 and Cycle 3 (Semi-Log Scale) • Exposure
Slide 23: CS5001 program summary
CS5001 program summary CS5001, a novel ROR1–directed PBD-ADC, appears well tolerated in heavily pre-treated patients with cancer across doses 7–195 μg/kg in the first-in-human study 1 • No DLT was observed and MTD was not reached • Lower toxicities were observed comparing to other relevant ADCs Enco
Slide 24: Pipeline Updates
Pipeline Updates 02 1. Commercial-stage Programs 2. Key Clinical Program – CS2009 3. Innovative Early Programs 24
Slide 25: Pipeline 2.0: an innovative portfolio with global rights
Pipeline advances Suzhou plant Cash runway management Well-balanced portfolio of 18 innovative assets – Pipeline 2.0: an innovative portfolio with global rights Preclinical Drug candidate Right Indication Discovery IND FIH POC Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS20
Slide 26: Overview of CS2009 (PD-1/CTLA-4/VEGFA trispecific antibody)
Overview of CS2009 (PD-1/CTLA-4/VEGFA trispecific antibody) A potentially FIC molecule; IND expected in 2024 Q4 Differentiated molecular design Preclinical data A potential FIC trispecific antibody PD-1xCTLA4 bispecific 1 targeting large indications 3 0 0 0 3000 In the immune-competent 2 5 0 0 2500
Slide 27: CS2009 key features
CS2009 key features PD-1/CTLA4/VEGFA trispecific Ab A FIC/BIC trispecific molecule with the potential to become the next-generation immune backbone to replace anti-PD-1/L1 Targeting large indications such as NSCLC, HCC, GC, etc., with substantial clinical and commercial potential • Composed of well-
Slide 28: Preclinical summary and development plan of CS2009
Preclinical summary and development plan of CS2009 Preclinical Assessments: ➢ Preferentially and effectively blocking PD-1/CTLA4 on double-positive TILs while sparing CTLA4 on single-positive cells to reduce systemic toxicity potentially ➢ High & rapid internalization leads to down-regulation of PD-
Slide 29: Pipeline Updates
Pipeline Updates 02 1. Commercial-stage Programs 2. Key Clinical Program – CS5001 & CS2009 3. Innovative Early Programs 29
Slide 30: Pipeline 2.0: an innovative portfolio with global rights
Pipeline advances Suzhou plant Cash runway management Well-balanced portfolio of 18 innovative assets – Pipeline 2.0: an innovative portfolio with global rights Preclinical Drug candidate Right Indication Discovery IND FIH POC Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS20
Slide 31: Overview of EGFR/HER3 bispecific antibody (CS2011) and ADC (CS5007)
Overview of EGFR/HER3 bispecific antibody (CS2011) and ADC (CS5007) Potential BIC molecules; IND expected in 2025 Differentiated Molecular Design Preclinical Data Potential BIC BxPC3 (EGFR++, HER3+) A549 (EGFR+++, HER3-) 15 1h 20 1h 4h 4h Molecular design rMFI to Isotype rMFI to Isotype 15 10 24h 24
Slide 32: CS5005 (SSTR2 ADC) Overview
CS5005 (SSTR2 ADC) Overview A FIC molecule; IND expected 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 SSTR2 selectivity 183.LZ4 183.HZ4 Selectivity of lead humanized cl
Slide 33: CS5006 (ITGB4 ADC) Overview
HT29 CS5006 (ITGB4 ADC) Overview 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; IND expected 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 34: CStone's Mature and Innovative Portfolio
CStone’s Mature and Innovative Portfolio Covers a Broad of Indications with Rapidly Growing Commercial Value 5,000K+ Global annual incidence[3] 2,000K+ Global annual incidence[2] ~200K China annual incidence[1] Precision Medicine Immuno-oncology Pipeline 2.0 • CS5001 (clinical) ROR1-ADC in leading p
Slide 35: Financial Highlights
03 Financial Highlights 35
Slide 36: 2024 H1 financial results
2024 H1 financial results Achieved profitability for the first time in company history with robust cash reserve Mn RMB 2024 H1 2023 H1 Change GROUP REVENUES 254.2 261.5 -3% Total Group Revenue of RMB 254.2 mn • Strong contribution from license fee income mainly composed of sugemalimab Sales of Pharm
Slide 37: Catalysts
04 Catalysts 37
Slide 38: Expected catalysts in the near term
Expected catalysts in the near term 2024 2025 Assets Q4 Q1 Q2 Q3 Q4 Initiation of pivotal trial Key clinical program Data presentation at Data presentation at CS5001 (ROR1 ADC) 2024 ASH 2025 ASCO Global BD partner exploration CS2009 (PD1/CTLA4/VEGFa tsAb) IND submission CS2011 (EGFR/HER3 bsAb) IND s
Slide 39: Thanks
Thanks 39
Slide 40: Appendix
Appendix 40 [Bel
Slide 41: Well-balanced portfolio of innovative assets (1/2): Commercial/late-stage programs
Well-balanced portfolio of 18 innovative assets (1/2) – Commercial/late-stage programs Approval Drug candidate Rights Indication POC Pivotal NDA Marketed Partner CN TW HK US EU UK 2L NSCLC 1L NSCLC Pralsetinib (RET) 1L MTC / TC （TC） （TC） Multiple tumors PDGFRA exon 18 GIST Avapritinib (KIT/PDGFRA) S
Slide 42: Well-balanced portfolio of innovative assets (2/2): Pipeline 2.0
Pipeline advances Suzhou plant Cash runway management Well-balanced portfolio of 18 innovative assets (2/2) – Pipeline 2.0: an innovative portfolio with global rights Preclinical Drug candidate Right Indication Discovery IND FIH POC Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancie
Slide 43: 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. Nicky Ni Yinghua Zhang MBA, CFA Chief Financial Officer Head of Operati
Slide 44: END
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CStone Pharmaceuticals — Investor Presentation (November 2024) on 6ix