Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — FY2024 Earnings Presentation
65 slides from Cstone Pharmaceuticals's earnings presentation, Mar 28, 2025
Slide 1: 2024 Annual Results Presentation
2024 Annual Results Presentation March 28th 2025 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: An Innovative Biopharma Driven by Globally Recognized R&D Capability
An Innovative Biopharma Driven by Globally Recognized R&D Capability Proven track record for high-quality and efficient drug development worldwide RESEARCH DEVELOPMENT COMMERCIAL Clinical insight driven Efficient, high-quality and Leverage the strength of modular R&D model innovative clinical dev. e
Slide 4: Business Achievements
01 Business Achievements 2024 & 2025YTD 4
Slide 5: FY2024 and 2025YTD achievements
FY2024 and 2025YTD achievements: encouraging data for key clinical assets and steady progress towards commercial partnerships Profitability for the first time in 2024H1; significant yoy improvement in FY2024 financial performance Financial R&D and Commercial Progress as of Dec. 31, 2024 as of Mar. 2
Slide 6: Pipeline Updates
Pipeline Updates 02 1. Commercial-stage Programs 2. Key Clinical Programs CS5001 (ROR1 ADC) CS2009 (PD-1/VEGF/CTLA-4 trispecific mAb) 3. Innovative Early Programs EGFR/HER3, SSTR2, ITGB4, Autoimmune 6
Slide 7: Maximizing commercial value of products and advancing Pipeline 2.0
To drive business growth by maximizing commercial value of products in the market and advancing innovative Pipeline 2.0 Key Clinical Programs Innovative Early Programs Commercial-stage Programs in Pipeline 2.0 in Pipeline 2.0 CS2011 CS5007 Sugemalimab CS5001 (EGFR/HER3 (EGFR/HER3 bispecific mAb) bis
Slide 8: Commercial-stage Programs
02 Commercial-stage Programs Pipeline Updates 8
Slide 9: First-line stage IV NSCLC approved in EU & UK; global partnerships
First-line stage IV NSCLC approved in EU & UK for all-comers population; three global partnerships established with additional collaborations anticipated in H1 2025 MAA approval achieved in EU & UK, positioning CStone as one of the Global partnerships to bring significant financial impact via immedi
Slide 10: Latest milestone advancing sugemalimab global strategy
Latest milestone highlighting our continuing progress to advance sugemalimab global strategy If this new indication is approved, sugemalimab would address a critical unmet need in stage III NSCLC, where only one PD-L1 antibody is currently approved in Europe. The drug's dual utility in stage III and
Slide 11: ESMO guideline recommendation and JAMA publication
ESMO guideline recommendation and JAMA publication further supporting sugemalimab's adoption by physicians and reimbursements Sugemalimab has been included in the ESMO Guideline and is recommended as a Publication of the GEMSTONE-303 study first-line combination therapy for both sq & nsq results of
Slide 12: Strategic collaboration on pralsetinib and avapritinib
Strengthening strategic collaboration on pralsetinib and avapritinib to maximize commercial value Actively advancing manufacturing localization and patient access Pralsetinib Nov 8 2023 Avapritinib Jul 3 2024 RET inhibitor KIT/PDGFRA inhibitor Partner with Partner with for the commercial promotion i
Slide 13: Significant volume increase for avapritinib after NRDL and partnership
Significant volume increase for avapritinib in the first year after entering NRDL and partnership with Hengrui Avapritinib’s 2024 in-market sales more than doubled compared to 2023 • NRDL implemented since Jan 1, 2024 • Strategic partnership with Hengrui initiated since Jul. 2024 • Domestic avapriti
Slide 14: Key Clinical Programs: CS5001 (ROR1 ADC)
02 Key Clinical Programs Pipeline Updates CS5001 (ROR1 ADC) 14
Slide 15: Pipeline 2.0: an innovative portfolio with global rights
Pipeline 2.0: an innovative portfolio with global rights CS5001: No. 2 position globally with first-to-market potential Preclinical Drug candidate Right Indication Discovery IND-Enabling FIH POC Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS2009 (PD-1/VEGF/CTLA-4 trispecific
Slide 16: CS5001, a ROR1-ADC with optimized design
CS5001, a ROR1-ADC with optimized design to enhance efficacy and tolerability No. 2 position globally with phase Ib study ongoing in US, Australia and China 4 key differentiators support best-in-class potential Novel prodrug and linker technology minimizes systemic toxicity of conventional PBD 1 Ful
Slide 17: ROR1 is a promising target for hematological malignancies and solid tumors
ROR1 is a promising target for multiple hematological malignancies and solid tumors 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, ovar
Slide 18: Global hematologic market holds vast potential
Global hematologic market holds vast potential: CS5001 poised to target multiple billion-dollar lymphoma indications Sizable value in solid tumor market in parallel, given CS5001’s promising anti-tumor activity observed in various solid tumors Global annual incident Proportion of different lymphomas
Slide 19: CS5001 may redefine DLBCL treatment paradigm
CS5001 may redefine DLBCL treatment paradigm, unlocking greater clinical benefit and commercial value DLBCL treatment landscape[1] Peak sales for DLBCL related drugs [2] Treatment lines Regimen 1 Regimen 2 R-CHOP POLA-R-CHP Rituximab (peak sales) ： Rituximab+Cyclophosphamide+Doxorubicin Polatuzumab
Slide 20: CS5001 demonstrates higher ORR as monotherapy in non-Hodgkin lymphoma
CS5001 demonstrates higher ORR as monotherapy in non-Hodgkin lymphoma CS5001 Zilovertamab Vedotin Molecule Property Target ROR1 ROR1 Linker Isoprenoid--glucuronide Mc-vc-PAB Payload Prodrug of PBD dimer MMAE DAR 2 Avg. 4 (0-8) Clinical Data Aggressive and indolent advanced NHL, r/r DLBCL r/r MCL in
Slide 21: MSD's waveLINE-007 data on ROR1 ADC in frontline DLBCL
Data from MSD’s waveLINE-007 demonstrated ROR1 ADC’s potential in frontline DLBCL Zilovertamab vedotin (ZV) + R-CHP (phase II clinical data of WaveLINE-007, ASH 2024) ZV 1.75mg/kg ZV 2.0mg/kg ZV 2.25mg/kg Total N=15 N=15 N=6 N=36 15 14b 6 35 Objective Responsea, % (95% CI) 100% (78.2 – 100.0) 93.3%
Slide 22: CS5001 clinical development targeting lymphoma and solid tumors
CS5001 clinical development targeting lymphoma and solid tumors: across first- line, frontline, monotherapy and combination therapies Phase Ib dose expansion ongoing, actively pursuing fast-to-market regulatory pathway Phase Ia – Monotherapy Dose Escalation Phase Ib -- Dose Expansion / Pivotal Exten
Slide 23: CS5001 PK profile
CS5001 PK profile: excellent linker stability with potentially reduced systemic toxicity CS5001 exhibits similar PK profile to total antibody, CS5001 demonstrates no significant accumulation indicating high ADC stability in circulation after multi-cycle dosing • CS5001 exhibits overall dose-proporti
Slide 24: CS5001 Summary
CS5001 Summary A potentially BIC with better efficacy and broader indications covering aggressive and indolent lymphoma, and solid tumors CS5001 is well tolerated in heavily pre-treated patients with advanced B-cell lymphoma and solid tumor across doses from 1 7 to 195 μg/kg. • Dose escalation compl
Slide 25: Key Clinical Programs: CS2009
Key Clinical Programs： 02 CS2009 Pipeline Updates (PD-1/VEGF/CTLA-4 trispecific mAb) 25
Slide 26: Pipeline 2.0: an innovative portfolio with global rights
Pipeline 2.0: an innovative portfolio with global rights CS2009: leading position globally to target PD-1, VEGFA and CTLA-4 Preclinical Drug candidate Right Indication Discovery IND-Enabling FIH POC Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS2009 (PD-1/VEGF/CTLA-4 trispec
Slide 27: CS2009, a potential FIC/BIC PD-1/VEGF/CTLA-4 trispecific antibody
CS2009, a potential FIC/BIC PD-1/VEGF/CTLA-4 trispecific antibody With greater potential than PD-1/VEGF bsAbs to become the next-generation IO backbone to replace anti-PD-(L)1 antibodies in current SOC A potential FIC/BIC trispecific Differentiated molecular design Preclinical data antibody targetin
Slide 28: Maximizing survival benefit with triple-targeting approach (1/2)
Maximizing survival benefit with PD-1/VEGF/CTLA-4 triple-targeting approach (1/2) "PD-1/L1 + VEGF" combination compared to PD-(L)1 monotherapy: unclear overall survival (OS) benefits IMpower150: KM plot of PFS in ITT population Arm B Arm A • "PD-1/L1 + VEGF" combination significantly improved PFS in
Slide 29: Maximizing survival benefit with triple-targeting approach (2/2)
Maximizing survival benefit with PD-1/VEGF/CTLA-4 triple-targeting approach (2/2) "PD-1/L1 + CTLA-4" combination shows significant PFS and OS benefits, particularly long-term OS improvement "PD-1/L1 + CTLA-4" combo shows significant PFS and OS benefits, particularly long-term OS improvement, e.g., N
Slide 30: PD-1/VEGF/CTLA-4 trispecific mAb holds clinical and commercial value
PD-1/VEGF/CTLA-4 trispecific mAb holds great clinical and commercial value Greater potential than PD-1/VEGF bsAbs to become the next-generation IO backbone to replace anti-PD-(L)1 antibodies in current SOC Approved indications for 3 Approved indications targets for PD-(L)1 Broad indications with hug
Slide 31: CS2009 global phase I trial ongoing in Australia
CS2009 global phase I trial ongoing in Australia, to be expanded to the US and China A phase I, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of CS2009 in patients with advanced solid tumors Phase Ia – Monotherapy Dose Escala
Slide 32: CS2009 balanced affinity and multi-target engagement
CS2009 has a balanced affinity ratio between PD-1 and CTLA-4, confirmed multi- target engagement with synergy, and potent checkpoint inhibitor (CPI) function Balanced binding affinity to PD-1 or CTLA-4, IL2 & IFN-γ release assays using PBMCs confirmed CS2009 enhanced affinity when engaged two target
Slide 33: CS2009 blocks PD-1 and CTLA-4 on double-positive TILs
CS2009 preferentially and effectively blocks PD-1 and CTLA-4 on double-positive TILs, while sparing CTLA-4 on single-positive T cells to reduce systemic toxicity 150 CHOs-PD-1/CTLA-4 150 unbound CTLA4 unbound CTLA4 %MFI %MFI %MFI %MFI unbound PD1 unbound PD1 150 150 100 unbound CTLA4 100 unbound CS1
Slide 34: CS2009 demonstrates equivalent VEGF-inhibitory activity as bevacizumab
CS2009 demonstrates equivalent VEGF-inhibitory activity as bevacizumab Octet HUVEC proliferation inhibition assay In the presence of 1.0 nM VEGFA 0.60 CS2009 0.55 AK112 Bevacizumab 0.50 OD492 No attenuation on binding affinity to VEGFA (KD: approx. 1e-12 M), 0.45 comparable to bevacizumab (KD: 2e-12
Slide 35: Synergy between CPI and VEGF arms
Synergy between CPI and VEGF arms: CS2009's CPI activity is enhanced by crosslinking with VEGFA dimers PD-1/CTLA-4 Dual-reporter Assay Mixed Lymphocytes Reaction (MLR) Assay H_CTLA4 PD-1 Jurkat Reporter Cell + IFNg H_CD80 PDL1 aAPC CHO-K1 IL-2 5 IFNg IFN-γ (fold change to blank) 100 nM 8 5 IFN-γ (fo
Slide 36: CS2009 Summary
CS2009 Summary CS2009 is a designed with confirmed IO function by in vitro / in vivo studies and full VEGF inhibitory activity as 1 bevacizumab. Synergy between PD-1 arm and CTLA-4 arm; and synergy between CPI arms and VEGF arm potentially enhance activities in TME and reduce systemic toxicities 2 C
Slide 37: Innovative Early Programs
02 Innovative Early Programs： Pipeline Updates 37
Slide 38: Pipeline 2.0: an innovative portfolio with global rights
Pipeline 2.0: an innovative portfolio with global rights Preclinical Drug candidate Right Indication Discovery IND-Enabling FIH POC Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) Solid tumors CS2011 (EGFR/HER3 bispecific antibody)
Slide 39: Innovative Early Programs: ADC platform and related assets
Innovative Early Programs： 02 ADC platform and related assets Pipeline Updates (EGFR/HER3, SSTR2, ITGB4) 39
Slide 40: Modular proprietary ADC platform
CStone has built a modular proprietary antibody drug conjugate (ADC) platform, enabling customized molecular design and screening Antibody • Customized target and antibody selections based on clinical needs and antibody features • High selectivity and internalization rate • To overcome tumor heterog
Slide 41: CS5007, a potentially best-in-class EGFR/HER3 bispecific ADC
Design Rationale EGFR/HER3 CS5007, a potentially best-in-class EGFR/HER3 bispecific ADC & its antibody backbone, CS2011 Potential best-in-class Differentiated Molecular Design Preclinical Data * Representative molecular configurations Molecular design CS5007 lead ADC demonstrated more potent tumor g
Slide 42: CS2011/CS5007 designed to overcome tumor heterogeneity
Design Rationale EGFR/HER3 CS2011/CS5007 designed to overcome tumor heterogeneity Simultaneously targeting EGFR homodimer, EGFR/HER3 heterodimer, EGFR/HER2 heterodimer, HER2/HER3 heterodimer • EGFR/HER3 bispecific antibodies (e.g. CS2011) can tackle almost all HER-family receptors except HER2 homodi
Slide 43: CS5005, a first-in-class SSTR2-ADC
Design Rationale SSTR2 CS5005, a first-in-class SSTR2-ADC based on CStone’s proprietary ADC platform Differentiated Molecular Design Preclinical Data A novel ADC on validated cancer target with FIC potential High SSTR2 selectivity Molecular Design • CStone’s proprietary anti-SSTR2 antibody with high
Slide 44: CS5005-RDC, a 2nd-generation RDC
Design Rationale SSTR2 CS5005-RDC, a 2nd-generation RDC by leveraging our proprietary anti-SSTR2 mAb Essential Module Advantages of anti-SSTR2 sdAb: Anti-SSTR2 sdAb sdAb Radionuclide • Delivers better tissue distribution than antibodies VL VH VH VL • Better selectivity than peptides. Converted to RD
Slide 45: CS5008, a first-in-class SSTR2xDLL3 bispecific ADC
SSTR2/DLL3 CS5008, a first-in-class SSTR2xDLL3 bispecific ADC based on CStone’s proprietary ADC platform Differentiated Molecular Design Preclinical Data FIC and potential BIC • Dual targeting SSTR2 and DLL3 overcomes intra/inter tumor heterogeneity. Molecular Design • Only ~10% of patients don’t ex
Slide 46: Rationale for simultaneous targeting DLL3 and SSTR2
Design Rationale SSTR2/DLL3 Rationale for simultaneous targeting DLL3 and SSTR2: both were highly overexpressed in SCLCs and neuroendocrine tumors/cancers (NETs/NECs) DLL3 is a clinically validated target for SCLCs with well- SSTR2 is a clinically validated target for NETs/NECs with overexpression i
Slide 47: CS5006, a first-in-class ITGB4-ADC
ITGB4 HT29 G1 Vehicle (PBS), i.v., 10μL/g, Single dose CS5006, a first-in-class ITGB4-ADC based on CStone’s proprietary ADC G2 H86.2-DXD (DARplatform 8), 10mg/kg, i.v., 10μL/g,Single dose 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
Slide 48: ITGB4 identified by AI-based ADC target discovery algorism
ITGB4 ITGB4 identified by AI-based ADC target discovery algorism Key selection criteria for indication specific novel TAAs AI-driven target prioritization workflow 1 Absolute protein over-expression in tumor tissues Top 100 indication Genome-wide machine learning ranking specific TAAs Minimal/no exp
Slide 49: Innovative Early Programs: Autoimmune
02 Innovative Early Programs： Pipeline Updates Autoimmune 49
Slide 50: CS2013, a potential best-in-class bispecific antibody for autoimmune diseases
CS2013, a potential best-in-class bispecific antibody to target autoimmune diseases Differentiated Molecular Design First-in-class/Best-in-class Molecular Design • B-cell directed therapeutics • Constructed for blocking two important ligands for B cell development and survival • Well-designed to tri
Slide 51: CS2015, a potential best-in-class bispecific antibody for type 2 inflammatory diseases
CS2015, a potential best-in-class bispecific antibody to target type 2 inflammatory diseases Differentiated Molecular Design First-in-class/Best-in-class Molecular Design • Th2 directed therapies • Constructed for blocking two important ligands for Th2 immune response • Well-designed to trigger syne
Slide 52: CStone's mature and innovative portfolio covers a broad range of indications
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 53: Financial Highlights
(Kime Financial Highlights
Slide 54: FY2024 financial results
FY2024 financial results Significantly lower operating loss on stringent cost control and business model transition Mn RMB FY 2024 FY 2023 Change GROUP REVENUES 407.2 463.8 -12% Total Group Revenues of RMB 407.2Mn Sales of Pharmaceutical Products 175.1 336.7 -48% • Strong contribution from license f
Slide 55: Catalysts
04 Catalysts 55
Slide 56: Expected Catalysts in the Near Term
Expected Catalysts in the Near Term 2025 Assets Q1 Q2 Q3 Q4 Exploring global BD partnerships for CS5001, CS2009, CS2011, CS5007, CS5005/CS5008 and CS5006 programs Data presentation at 2025 clinical CS5001 (ROR1 ADC) ASH Key Phase I clinical data CS2009 (PD-1/VEGF/CTLA-4 tsAb) Phase Ia study initiati
Slide 57: Thanks
Thanks 57
Slide 58: Appendix
Appendix 58 [HE
Slide 59: Well-balanced portfolio of innovative assets (1/2)
Well-balanced portfolio of 16 innovative assets (1/2) – Commercial/Late-stage Programs Approval Drug candidate Indication POC Pivotal NDA Marketed Partners Partnering regions CN TW HK US EU UK 2L NSCLC 1L NSCLC Pralsetinib (RET) Mainland China 1L MTC / TC （TC） （TC） Multiple tumors PDGFRA exon 18 G
Slide 60: Well-balanced portfolio of innovative assets (2/2)
Well-balanced portfolio of 16 innovative assets (2/2) – Pipeline 2.0 Preclinical Drug candidate Right Indication Discovery IND-Enabling FIH POC Development Solid tumors CS50011 (ROR1 ADC) hematologic malignancies CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) Solid tumors CS2011 (EGFR/HER3 bispecifi
Slide 61: 60% ORR among evaluable Hodgkin lymphoma patients
60% ORR among 10 evaluable Hodgkin lymphoma at dose levels 5 to 9; 100% ORR (2 CRs & 1 PR) observed in dose level 8 cohort (125 μg/kg) Best overall response (BOR) in evaluable patients with Hodgkin lymphoma DL4 DL5 DL6 DL7 DL8 DL9 All DLs BOR, n(%) 33.5 µg/kg 50 µg/kg 75 µg/kg 100 µg/kg 125 µg/kg 15
Slide 62: 56% ORR among evaluable non-Hodgkin lymphoma patients
56% ORR among 16 evaluable non-Hodgkin lymphoma at dose levels 7 to 9; 70% ORR in dose level 8 cohort (125 μg/kg) Best overall response (BOR) in evaluable patients with non-Hodgkin lymphoma Non-Hodgkin Lymphoma • Objective responses observed from DL7 (100 μg/kg) and above, including 3 CRs (2 DLBCL a
Slide 63: CS5001 anti-tumor activities in solid tumors
CS5001 demonstrates anti-tumor activities in solid tumors (NSCLC, pancreatic cancer, etc.) in addition to lymphomas 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/kg 50 µg/kg 75 µg/kg 100 µg/kg
Slide 64: Bioinformatics analysis supports DLL3/SSTR2 dual-targeting
Design Rationale Bioinformatics analysis on SCLC samples supports DLL3/SSTR2 dual-targeting to overcome tumor heterogeneity DLL3 expression is driven by ASCL1 Dual targeting SSTR2 and DLL3 overcomes tumor heterogeneity and expands target population SSTR2 expression is driven by NEUROD1 • Coexpressio
Slide 65: END
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CStone Pharmaceuticals — FY2024 Earnings Presentation on 6ix