Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — Investor Presentation (September 2020)
36 slides from Cstone Pharmaceuticals's investor presentation, September 2020
Slide 1: CStone Pharmaceuticals Company Presentation
CSTONE PHARMACEUTICALS (2616.HK) COMPANY PRESENTATION September, 2020
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 with it
Slide 3: To Become Globally Recognized as the Leading Chinese Biopharma
To Become Globally Recognized as the Leading Chinese Biopharma 4 Years Since Company HKEx listed Inception 2616.HK Industry-leading $150M $262M $328M Management Team Series A Series B HK IPO (July 2016) (May 2018) (Feb 2019) Well-balanced Integrated Biopharma with Clear Oncology Portfolio with a Foc
Slide 4: Industry leading management team with proven track record and complementary expertise
Industry leading management team with proven track record and complementary expertise Frank Jiang, MD, PhD Chairman, Chief Executive Officer Shirley Zhao, MD, MBA Jason Yang, MD, PhD Greater China GM, Chief Medical Officer Head of Commercial Bing Yuan, PhD, MBA Jon Wang, PhD Archie Tse, MD, PhD Chie
Slide 5: Distinguished world-class scientific advisory board with deep oncology and IO expertise
Distinguished world-class scientific advisory board with deep oncology and IO expertise Paul Bunn Elizabeth Jaffee Weiping Zou Richard Finn MD MD MD, PhD MD Former ASCO President Former AACR President Chair, AACR Cancer Former International 2002-2003 2018-2019 Immunology Liver Cancer Distinguished P
Slide 6: Well-balanced oncology portfolio with a focus on immuno-oncology and precision medicine
Well-balanced oncology portfolio with a focus on immuno-oncology and precision medicine Lead Indication(s) Dose Drug Candidate Rights Pre-clinical POC Pivotal NDA Partner and Line(s) of Escalation Therapies Sugemalimab NSCLC, GC, EC (CS1001, PD-L1) R/R NKTL CS1003 HCC (PD-1) Late-stage Ivosidenib R/
Slide 7: Focus on China's largest indications, covering 55%+ of total cancer incidences
Focus on China’s largest indications, covering 55%+ of total cancer incidences Colorectal Esophagus Cancer type Lung Cancer Gastric Cancer Liver Cancer Cancer Cancer New cases 774,323 516,859 456,124 392,868 307,359 (2018) 5-year prevalence (2018) 716,411 1,237,145 603,851 296,780 284,163 PD-L1 Mono
Slide 8: Differentiated Combo Strategy anchored around 3 I/O backbone agents
Differentiated Combo Strategy - driven by sizable portfolio anchored around 3 I/O backbone agents ■ ■ ■ 3 Only company in China owns clinical stage 15 10 in-house developed de- risked assets plus 1 PD-L1x4-1BB provides more flexible combo potential 2nd IO backbone PD-L1, PD-1 assets in 5 in-licensed
Slide 9: Clinical Development Engine: Strong in-house team and global CROs
9 Clinical Development Engine: Strong in-house team led by experienced leaders and supported by global CROs Frank Jiang, MD, PhD Chairman and CEO ▪ Former Head of APAC R&D for Sanofi ▪ Led a 21,000 patient mega-trial ▪ Led 79 clinical trials and 30 NDAs within five years Jason Yang, MD, PhD Archie T
Slide 10: Significant clinical progress - overview
Significant clinical progress - overview 30 trials initiated including 5 assets in 15 registrational trials Sugemalimab ◼ 6 registrational trials in China (PD-L1) ◼ Stage III NSCLC, stage IV NSCLC, GC, ESCC, NKTL and cHL CS1003 ◼ 1 registrational trial (PD-1) ◼ HCC (global) Ivosidenib ◼ 2 registrati
Slide 11: Significant clinical progress – Sugemalimab (PD-L1) (1/6)
Significant clinical progress – Sugemalimab (PD-L1) (1/6) Asset overview ■ Fully-human, full length IgG4 derived from Ligand’s OmniRat® platform – minimal possibility of generating ADA; ■ The only PD-L1 antibody that naturally lacks of ADCC/CDC activity – better safety Unique design and avoid unwant
Slide 12: Significant clinical progress – Sugemalimab (PD-L1) (2/6)
Significant clinical progress – Sugemalimab (PD-L1) (2/6) Phase Ia & Ib study data: best-in-class potential in multiple indications in POC data Arm 1: Hematologic Malignance Arm 2: MSI-H/dMMR Solid Tumor* Mono Arm 3: Cholangiocarcinoma or gallbladder carcinoma* Arm 4: Undisclosed Solid Tumor Arm 5:
Slide 13: Significant clinical progress – Sugemalimab (PD-L1) (3/6)
Significant clinical progress – Sugemalimab (PD-L1) (3/6) Phase Ib study data: Sugemalimab + platinum-based chemo in 1L advanced NSCLC Squamous NSCLC Cohort: ORR=75% (15/20), DCR=95% (19/20) Arm 9: sq NSCLC(1L) 80 75 72.5 PR 100 ORR*: 75% (15/20) SD 62.6 80 DCR: 95% 60 49.7 ORR (%) 60 Percent Change
Slide 14: Significant clinical progress – Sugemalimab (PD-L1) (4/6)
Significant clinical progress – Sugemalimab (PD-L1) (4/6) Phase Ib study data: Sugemalimab + platinum-based chemo in 1L advanced NSCLC Non-Squamous NSCLC Cohort: ORR=47.6% (10/21), DCR=90.5% (19/21) Arm 8: non-sq NSCLC(1L) PR 60 100 ORR*: 47.6% (10/21) SD 47.6 47.6 49.2 80 DCR: 90.5% PD 50 ORR (%) 6
Slide 15: Significant clinical progress – Sugemalimab (PD-L1) (5/6)
Significant clinical progress – Sugemalimab (PD-L1) (5/6) Phase Ib study data in 1L ESCC and Phase II study data in rr-ENKTL Sugemalimab + CF (Cisplatin + 5 FU) in 1L ESCC Sugemalimab as monotherapy in rr-ENKTL ORR=77.8% (14/18), DCR=88.9% (16/18) ORR = 43.3% (13/30), CR = 33.3% (10/30), DOR not rea
Slide 16: Significant clinical progress – Sugemalimab (PD-L1) (6/6)
Significant clinical progress – Sugemalimab (PD-L1) (6/6) Phase Ib study data: other cohorts Sugemalimab + XELOX (Capecitabine + Oxaliplatin) in 1L GC/GEJ (Gastric or Sugemalimab (PD-L1) as monotherapy in Gastroesophageal Junction CC/GBC (Cholangiocarcinoma or Sugemalimab (PD-L1) as monotherapy in A
Slide 17: Significant clinical progress – CS1003 (PD-1) & CS1002 (CTLA-4)
Significant clinical progress – CS1003 (PD-1) & CS1002 (CTLA-4) Two Additional I/O Backbones: preliminary data and development strategy CS1003 CS1002 overview ■ Humanized IgG4 anti-PD-1 mAb ■ A full-length, fully human IgG1 mAb against CTLA4 Asset ■ Recognize both human & murine PD-1 with unique ■ A
Slide 18: Significant clinical progress – ivosidenib (CS3010)
Significant clinical progress – ivosidenib (CS3010) Global and China development and regulatory status Global Pivotal / Registrational Trial NDA Partner Drug Candidate Target Indications NDA Approval Patient Enrollment Submission R/R AML IC-Ineligible 1L AML monotherapy Ivosidenib IDH1 IC-Ineligible
Slide 19: TIBSOVO: global first-in-class IDH1 inhibitor
TIBSOVO®: global first-in-class IDH1 inhibitor No immediate competitor in China; significant indication expansion potential In Partnership With Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML 1 .0 C R +C Rh 0 .9 N o n -C R /C R h re s p o n d e rs 0 .8 N o n -re s p o n
Slide 20: Significant clinical progress – avapritinib (CS3007)
Significant clinical progress – avapritinib (CS3007) Global and China development and regulatory status Global Drug Pivotal / Registrational Trial U.S. NDA U.S. NDA Partner Target Indications Candidate Patient Target Enrollment Submission Approval PDGFRA exon 18 GIST Avapritinib KIT & (1) Advanced S
Slide 21: Avapritinib: global first-in-class PDGFRA/KIT inhibitor
Avapritinib: global first-in-class PDGFRA/KIT inhibitor Targeted therapy with significant indication expansion potential In Partnership With Encouraging Clinical Activity Shown in NAVIGATOR Registrational Phase 1 Study Safety Summary ◼ Most AEs were grade 1 or 2, with a higher incidence of commonly
Slide 22: Significant clinical progress – pralsetinib (CS3009)
Significant clinical progress – pralsetinib (CS3009) Global and China development and regulatory status Global Drug Pivotal / Registrational Trial U.S. NDA U.S. NDA Partner Target Indications Candidate Patient Target Enrollment Submission Approval NSCLC * Pralsetinib RET 2L TC/MTC Achieved To be exp
Slide 23: Pralsetinib: potentially first-in-class RET inhibitor
Pralsetinib: potentially first-in-class RET inhibitor Targeted therapy with significant indication expansion potential In Partnership With Broad and Durable Antitumor Activity in Patients with RET Fusion+ NSCLC ARROW AL L NSCL C PATI ENTS ( 4 0 0 MG Q D) Safety Summary PER CENTRAL RADI O L O G Y ◼ S
Slide 24: Significant clinical progress on other clinical-stage assets
Significant clinical progress on other clinical-stage assets ◼ Conducting a Ph I trial (join global) for HCC as monotherapy in China CS3008 / and plan to publish results (CN part) in CSCO 2020 Fisogatinib (FGFR4) ◼ Conducting a Ph Ib/II trial for HCC as combo with Sugemalimab (PD-L1) in China and in
Slide 25: CStone is driving pipeline 2.0 for sustained growth
CStone is driving pipeline 2.0 for sustained growth Pipeline 1.0 GAP Analysis Pipeline 2.0 Balanced New Advanced Portfolio Targets Portfolio De-risked “Practice changing” potential? ◼ FIC, Novel pathway I/O Backbone & Assets Convincing combo activity ◼ FIC/FW/BIC multi-functional Precision Medicine
Slide 26: Focus areas: novel biology, multi-functional biologics, cancer vaccines
Focus areas: novel biology, multi-functional biologics, cancer vaccines Wuxi ■ CStone Internal Discovery Platform DDSU ■ “Hub & Spoke” models for internal projects Company C ➢ CStone names the targets; Internal Project Leader and Wuxi Apptec Project Manager to run projects ➢ Lead discovery & optimiz
Slide 27: NM21-1480 has the potential to be the BIC next generation PD-(L)1 inhibitor
NM21-1480 (PD-L1x4-1BBxHSA) has the potential to be the BIC molecule as the next generation PD-(L)1 inhibitor Mean relative tumor volume ■ Bridge new biology ■ Improve therapeutic index & reduce 1 Irrelevant IgG (Palivizumab) mean RTV (%of baseline) 1000 2 NM21-1186 (0.02 mg/occasion) unwanted toxic
Slide 28: Strategically partnering with global and domestic leading biopharmaceutical companies
Strategically partnering with global and domestic leading biopharmaceutical companies in past two years 1 5 FIC/BIC Assets from 3 Global Partners ▪ Tibsovo (IDH1) ▪ Avapritinib (KIT & PDGFRA) ▪ NM21-1480 ▪ Pralsetinib (RET) ▪ Fisogatinib (FGFR4) 2 3 Clinical Collaborations Deals Focused on IO Combo
Slide 29: Global collaboration to evaluate PD-L1 in combination with regorafenib
Global collaboration deal with China focus to evaluate PD-L1 in combination with regorafenib in key indications PD-L1 Regorafenib reported promising data with PD-1 in gastric cancer and colorectal cancer at ASCO 2019 ◼ First collaboration with a MNC pharma, Indication Mono/Combo ORR Highlights one o
Slide 30: Significant commercialization progress – multiple products in coming years
Significant commercialization progress – multiple products covering over 10 indications in coming years Near-term (2020~2021) Mid-term (2022~2025) Long-term (2026~) Expect ~13 potentially approved products Across 20+ indications1 Expect ~6 products Across 14+ indications1 Avapritinib PDGFRA GIST, SM
Slide 31: Shirley Zhao, a top commercial executive to build commercial capabilities
Shirley Zhao, a top commercial executive with 26 years experience to build and scale up commercial capabilities in Greater China Greater China GM • Former BMS China mainland and HK General & Head of Commercial Manager (GM), brought China’s first PD-1 (OPDIVO) to the market and led a $650M commercial
Slide 32: Full-fledged commercial organization being scaled up for multiple launches
Full-fledged commercial organization being scaled up for multiple launches in the next 2 years Stage 3 2023+ Stage 2 2021-2023 Stage 1 2018-2021 1 ▪ Establish commercial 2 ▪ Full launch of PD-L1 3 ▪ First wave of product organization with core and in-licensed assets launches outside China1, function
Slide 33: State-of-the-art manufacturing facility in construction
State-of-the-art manufacturing facility in construction to be in full operation by next year ◼ In August 2019, CStone entered into an agreement with Sungent (state-owned controlled by Suzhou Industrial Park) to build manufacturing facility ◼ Commencement of the construction in the first half of 2020
Slide 34: Financial summary for 1H 2020
Financial summary for 1H 2020 ◼ RMB2,124 million of cash, cash equivalents, and time deposits as of June 30, 2020 vs. RMB2,726 million as of December 31, 2019 Cash Balance ◼ Cash position decreased by RMB602 million mainly due to R&D expenses, administrative and selling expenses ◼ IPO proceeds: HK$2
Slide 35: Outstanding execution in 2020YTD with multiple milestones achieved
Outstanding execution in 2020YTD with multiple thrilling milestones achieved and more to come Milestones achieved in 2020YTD To be achieved for rest of 2020 NDA Approval NDA Submission ◼ Ivosidenib (IDH1): r/r AML, Taiwan ◼ Sugemalimab (PD-L1): Stage IV NSCLC, China NDA Submission ◼ Pralsetinib (RET
Slide 36: Thank you!
dG] 204 ba S tansceunicats Thank you!
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