Cstone Pharmaceuticals · HKEX:2616
Cstone Pharmaceuticals — Investor Presentation (April 2020)
37 slides from Cstone Pharmaceuticals's investor presentation, April 2020
Slide 1: CStone Pharmaceuticals (2616.HK) Company Presentation
CSTONE PHARMACEUTICALS (2616.HK) COMPANY PRESENTATION April, 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 CS1001 R/R cHL, R/R NKTL, (PD-L1) NSCLC, GC, EC CS1003 HCC, Solid tumors (PD-1) Late-stage Iv
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: Sizable portfolio anchored around IO backbone agents to drive differentiated combo strategy
Sizable portfolio anchored around 3 IO backbone agents to drive differentiated combo strategy ■ ■ ■ 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 gen
Slide 9: Clinical Development Engine: Strong in-house team led by experienced leaders
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 28 trials including 5 assets in 13 registrational trials today CS1001 ◼ 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 registrational tria
Slide 11: Significant clinical progress – CS1001 (PD-L1) (1/5)
Significant clinical progress – CS1001 (PD-L1) (1/5) 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 unwanted at
Slide 12: Significant clinical progress – CS1001 (PD-L1) (2/5)
Significant clinical progress – CS1001 (PD-L1) (2/5) 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: Esoph
Slide 13: Significant clinical progress – CS1001 (PD-L1) (3/5)
Significant clinical progress – CS1001 (PD-L1) (3/5) Phase Ib study data: CS1001 + CF (Cisplatin + 5-FU) in 1L ESCC Esophageal Squamous Cell Carcinoma: ORR=77.8% (14/18), DCR=88.9% (16/18) 100 77.8 80 ORR (%) 60 46.7 ORR*: 77.8.1% (14/18) 33.3 DCR: 88.9% 40 DOR: not reached 20 0 Durvalumab+ CS1001 T
Slide 14: Significant clinical progress – CS1001 (PD-L1) (4/5)
Significant clinical progress – CS1001 (PD-L1) (4/5) Phase Ib study data: other cohorts CS1001 + XELOX (Capecitabine + Oxaliplatin) in 1L GC/GEJ (Gastric or CS1001 (PD-L1) as monotherapy in Gastroesophageal Junction CC/GBC (Cholangiocarcinoma or CS1001 (PD-L1) as monotherapy in Adenocarcinoma) Gallb
Slide 15: Significant clinical progress – CS1001 (PD-L1) (5/5)
Significant clinical progress – CS1001 (PD-L1) (5/5) Phase II study data: CS1001 as monotherapy in rr-ENKTL Duration of treatment, Best response, Duration of response (N=30) Preliminary efficacy data ORR = 43.3% (13/30), CR = 33.3.% (10/30), DOR not reached 1Yr OS rate: 72.4% as of data cut-off on 8
Slide 16: Significant clinical progress – CS1003 (PD-1) and CS1002 (CTLA-4)
Significant clinical progress – CS1003 (PD-1) and 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 ■
Slide 17: 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 18: TIBSOVO: global first-in-class IDH1 inhibitor
TIBSOVO®: global first-in-class IDH1 inhibitor No immediate competitor in China; significant indication expansion potential Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML In Partnership With 1 .0 C R +C Rh 0 .9 N o n - C R /C R h r e s p o n d e r s 0 .8 N o n -re s p
Slide 19: 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 4L GIST Avapritinib KIT & (CS300
Slide 20: 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 21: 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 MTC Achieved To be expe
Slide 22: 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 23: Significant clinical progress on other clinical-stage assets
Significant clinical progress on other clinical-stage assets ◼ Conducting a Ph I trial for solid tumors as monotherapy in CS3005 Australia/China and plan to initiate a combo with CS1003 (PD-1) (A2aR) thereafter ◼ Conducting a Ph I trial for solid tumors as monotherapy in CS3002 Australia/China and p
Slide 24: 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 25: Focus areas: novel biology, multi-functional biologics, cancer vaccines
Focus areas: novel biology, multi-functional biologics, cancer vaccines Wuxi DDSU ■ CStone Internal Discovery Platform Company ■ “Hub & Spoke” models for internal projects Wuxi C ➢ CStone names the targets; Internal PL&PM to run projects Apptec ➢ Lead discovery & optimization done at CRO or platform
Slide 26: ND021 (PD-L1x4-1BBxHSA) has the potential to be the BIC next generation PD-(L)1 inhibitor
ND021 (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 eff
Slide 27: 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) ▪ ND021 ▪ Pralsetinib (RET) ▪ Fisogatinib (FGFR4) 2 3 Clinical Collaborations Deals Focused on IO Combo Ther
Slide 28: Global collaboration deal 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 29: We will focus on precision medicine in the near-term, followed by PD-(L)1 across China
We will focus on precision medicine in the near-term, followed by PD-(L)1 across China prevalent indications in the longer term Near-term (2020~2021) Mid-term (2022~2025) Long-term (2026~) Expect ~13 potential approved products Across 20+ indications1 Expect ~6 products Across 15 indications1 PDGFRA
Slide 30: Shirley Zhao, a top commercial executive with 26 years experience
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 31: Full-fledged commercial organization being scaled up for multiple launches in the next 2 years
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 32: Developing strong manufacturing capabilities for both biologics and small molecules
Developing strong manufacturing capabilities for both biologics and small molecules ◼ In August, we entered into an agreement with Sungent (state-owned controlled by Suzhou Industrial Park) to build manufacturing facility ◼ Planned building area of approximately 100,000 sqm ◼ Commissioned to a third
Slide 33: Financial summary in 2019
Financial summary in 2019 Cash position ◼ RMB2,726 million of cash, cash equivalents, and time deposits as of December 31, 2019 vs. RMB1,463 million as of December 31, 2018 ◼ Cash position increased by RMB1,263 million mainly due to proceeds Cash Balance from our IPO in February 2019 ◼ IPO proceeds:
Slide 34: Financial summary in 2019 (continued)
Financial summary in 2019 (continued) Key income statement items Other Income (RMB mm) Adjusted R&D Expenses1 (RMB mm) 100 1,400 84 1,189 1,200 80 1,000 60 800 727 40 600 20 400 20 14 196 200 - - 2017 2018 2019 2017 2018 2019 Adjusted Administrative Expenses1 (RMB mm) Adjusted Loss for the Period2 (
Slide 35: 2019 performance in perspective
2019 performance in perspective 2019 guidance 2019 actual performance By the number By the number ◼ 25+ clinical trials by year end ◼ 28 clinical trials by year end ◼ Including 10+ registrational studies ◼ Including 13 registrational studies ◼ Approximately 10+ combination therapy trials ◼ 11 combin
Slide 36: 2020 will be a key inflection point for CStone, expecting the following major catalysts
Exciting year: 2020 will be a key inflection point for CStone, expecting the following major catalysts and goals By year end 2020, 30+ clinical trials initiated, including 15 for registration 1 NDA TIBSOVO ◼ r/r AML, Taiwan approval Ivosidenib PD-L1 ◼ cHL (potentially NKTL), China ◼ PDGFRA exon 18 G
Slide 37: Thank you!
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