Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — H1 2024 Earnings Presentation
40 slides from Cstone Pharmaceuticals's earnings presentation, Aug 26, 2024
Slide 1: 2024 Interim Results Presentation
2024 Interim Results Presentation August 26, 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 Aug. 26, 2024 2 New NDA approvals 1 NDA currently under review Total revenue [1] in 2024 H1 1L GC/GEJC Sugemalimab Sugemalimab 1L stage IV NSCLC 254.2 1L stage IV NSCLC RMB Mn (Flat YoY) 5 Data publications / presentatio
Slide 6: Pipeline Updates
Pipeline Updates 02 1. Commercial-stage Programs 2. Key Clinical Program 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 CS2009 (PD-1/CTLA4/VEGF trispecific mAb) Sugemalimab (PD-L1) CS5001 CS5005
Slide 8: Pipeline Updates
Pipeline Updates 02 1. Commercial-stage Programs 2. Key Clinical Program 3. Innovative Early Programs 8
Slide 9: Sugemalimab (anti-PD-L1 mAb) (1/2)
Sugemalimab Sugemalimab (anti-PD-L1 mAb) (1/2) All 5 indications approved in mainland China; 1L treatment of NSCLC approved by EC and proceeding smoothly at UK MHRA; in active discussion with global partners Regulatory Progress 2021 2022 2023 2024… Stage IV NSCLC R/R ENKTL GC/GEJC CN Stage III NSCLC
Slide 10: Sugemalimab (anti-PD-L1 mAb) (2/2)
Sugemalimab Sugemalimab (anti-PD-L1 mAb) (2/2) EU approval granted; first global partnership achieved and more to come in 2024 H2 MAA approval achieved in EU, positioning CStone as one of the Global partnerships to bring significant financial impact via immediate few Chinese biotechs to launch drugs
Slide 11: 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 12: Pipeline Updates
Pipeline Updates 02 1. Commercial-stage Programs 2. Key Clinical Program 3. Innovative Early Programs 12
Slide 13: Pipeline 2.0 – An Innovative Portfolio with Global Right
Pipeline advances Suzhou plant Cash runway management Pipeline 2.0 – An Innovative Portfolio with Global Right Preclinical Drug candidate Rights Indication Discovery IND FIH POC Partner Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS2009 (PD-1xCTLA4xVEGFa Solid tumors trispec
Slide 14: 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 15: 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 16: CS5001 phase I trial design and fast-to-market 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 17: CS5001 safety profile (1/3)
Safety Efficacy PK CS5001 safety profile (1/3): Well tolerated in heavily pre-treated patients; Most TRAEs of grade 1/2 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%) TEAE
Slide 18: CS5001 safety profile (2/3)
Safety Efficacy PK CS5001 safety profile (2/3): 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 (125 ug/kg) Hematologic TEAEs Non-hematologic TEAEs (incidence ≥ 25%) (incidence ≥
Slide 19: CS5001 safety profile (3/3)
Safety Efficacy PK CS5001 safety profile (3/3): 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/k
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 Best overall response (BOR) in Evaluable Patients with Lymphomas DL1-4 DL5 DL6 DL7 DL8 DL9 All DLs BOR 7-33.5 µg/kg 50 µg/kg 75 µg/kg 100 µg/kg 125 µg/kg 156 µg/kg (n=21) (n=2) (n=2) (n=5) (n=8) (n=3) (n=1) CR 0
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 3. Innovative Early Programs 24
Slide 25: 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 CS2011 CS5007 PD-1/CTLA-4/VEGFa SSTR
Slide 26: CS2009 (PD-1/CTLA-4/VEGFa trispecific antibody)
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 model, CS200
Slide 27: CS5005 (SSTR2 ADC)
CS5005 (SSTR2 ADC) 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 clones Comm
Slide 28: 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; 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(DA
Slide 29: CS2011 (EGFR/HER3 bispecific antibody) & CS5007 (EGFR/HER3 bispecific ADC)
CS2011 (EGFR/HER3 bispecific antibody) & CS5007 (EGFR/HER3 bispecific ADC) Potential BIC molecules; IND expected in 2025 Differentiated Molecular Design Preclinical Data Potential BIC SW620 A549 3 1h 20 1h 4h 4h Molecular design rMFI to Isotype rMFI to Isotype 15 2 24h 24h 10 1 5 • Full blockage of
Slide 30: 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 • Pralsetinib (commercial) • Sugemalimab
Slide 31: Financial Highlights
03 Financial Highlights 31
Slide 32: 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 33: Catalysts
04 Catalysts 33
Slide 34: Expected catalysts in the near term
Expected catalysts in the near term Assets Catalysts Date 2024 H1 Phase I data presentation at 2024 ASCO (presented) and ASH & 2024 H2 Key clinical CS5001 (ROR1 ADC) Initiation of phase Ib trial with registrational potential 2024 H2 program Global BD partnership 2024/2025 CS2009 (PD1/CTLA4/VEGFa tsA
Slide 35: Thanks
Thanks 35
Slide 36: Appendix
Appendix 36 [HE
Slide 37: Well-balanced portfolio of innovative assets (1/2) – commercial/late-stage programs
Well-balanced portfolio of 16 innovative assets (1/2) – commercial/late-stage programs Approval Drug candidate Rights Indication POC Pivotal NDA Marketed Partner CN TW HK US EU 2L NSCLC 1L NSCLC Pralsetinib (RET) 1L MTC / TC （TC） （TC） Multiple tumors PDGFRA exon 18 GIST Avapritinib (KIT/PDGFRA) SM1
Slide 38: Well-balanced portfolio of innovative assets (2/2) – pipeline 2.0
Well-balanced portfolio of 16 innovative assets (2/2) – pipeline 2.0 Preclinical Drug candidate Rights Indication Discovery IND FIH POC Partner Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS2009 (PD-1xCTLA4xVEGFa Solid tumors trispecific antibody) CS5006 (Undisclosed ADC) So
Slide 39: 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 40: END
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CStone Pharmaceuticals — H1 2024 Earnings Presentation on 6ix