Oncolys Biopharma, Inc. · TSE:4588

Oncolys Biopharma — H1 2017 Earnings Presentation

37 slides from Oncolys Biopharma's earnings presentation, Aug 4, 2017

  1. Slide 1: Financial Results Presentation

    First Half of the Fiscal Year ending December 2017 Financial Results Presentation August 4, 2017 Oncolys BioPharma Inc. (TSE mothers: 4588) Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved.

  2. Slide 2: Forward looking statements

    Forward looking statements • This presentation material may contain information which is forward-looking and involves risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. One can identify these forward-looking statements

  3. Slide 3: Table of Contents

    Table of Contents 1. Financial results and future outlook 2. Telomelysin 3. TelomeScan 4. OBP-AI-004 5. Zika vaccine Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved.

  4. Slide 4: Our pipeline: oncolytic virotherapy platform

    Our pipeline: oncolytic virotherapy platform Systemic treatment Prognosis follow-up Regional treatment O N OH H HN S O S NH Early detection O O O OBP-702 OBP-405 Oncolytic virotherapy platform Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved. 4

  5. Slide 5: Financial year ending December 2017 full year forecast

    Financial year ending December 2017 full year forecast JPY in million Sales OP CP NP Forecast FY 2017 200 △1,400 △1,400 △1,400 Results FY 2016 178 △861 △864 △931  Sales: License fee and sales of virus  Loss: Investment in R&D and increase in patent-related costs (JPY 0.9bn) foreign currency fluctu

  6. Slide 6: First half of FY2017: earnings results

    First half of FY2017: earnings results JPY in million Sales OP CP NP FY2017 First Half 19 △509 △517 △518 FY2016 First Half 44 △410 △416 △417 (ref.） 178 △861 △864 △931 FY 2016 full year Sales 1. License fee for TelomeScan from Wonik Cube 2. Sales of TelomeScan to Deciphera OP 1. Cost reduction effort

  7. Slide 7: First half of FY2017: achievements/status

    First half of FY2017: achievements/status ＜R&D-related＞ 1. Melanoma P2 FPI 2. Esophageal cancer P1 FPI OBP-301 3. HCC P1/2 Multiple administration (Cohort 5) started “Telomelysin®” 4. Solid tumors, with PD-1 P1/2 CTN submitted and a kick-off meeting held ＜Business-related＞ 1. Hengrui's GMP facilitie

  8. Slide 8: Funding: third party allotment

    Funding: third party allotment MSCB financing announced in December 2016 is almost complete.  About 91% executed and the total amount raised is JPY 1.3 bn (as of 31 July 2017) <MSCB execution status> 9% 91% Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved. 8

  9. Slide 9: Comparison: budget and actual expenses FY2017

    Comparison: budget and actual expenses FY2017 <1H results vs. FY2017 full year forecasts> 1,600 SA&G 520 33% ＜Main factors＞  Delayed Telomelysin GMP acceptance inspection  Delayed melanoma trial due to additional documentations 700 for NIH R&D 200 29％  Reduced NG Telomelysin-related patent cost 

  10. Slide 10: For "Good" medicine

    Business concept 1. Realizing oncolytic virotherapy 2. Developing treatments for intractable diseases For “Good” medicine Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved. 10

  11. Slide 11: Table of Contents

    Table of Contents 1. Financial results outline and future outlook 2. Telomelysin 3. TelomeScan 4. OBP-AI-004 5. Zika vaccine Copyright(C) 2017 , Oncolys BioPharma Inc. All rights reserved.

  12. Slide 12: Telomelysin: oncolytic virotherapy

    Telomelysin：oncolytic virotherapy Normal cell (Telomerase activity－） No replication No cytophathy Induced cell death and diffusion of Cancer cell Replication of Telomelysin Telomelysin (Telomerase activity+) Ref.) The Lancet Oncology Vol. 3 Jan. 2002 Colorectal （15 days after administration） Lung Da

  13. Slide 13: Clinical trials updates

    Clinical trials updates Copyright(C) 2017 , Oncolys BioPharma Inc. All rights reserved.

  14. Slide 14: Melanoma: FPI in the US

    Melanoma：FPI in the US  FPI achieved in Atlantic Cancer Center on 28 July  Oncolys pushing ahead to speed up the enrollment of patients in 5 sites Final Visit Week* 0 2 4 6 8 10 12 14 16 18 20 22 24 mandatory mandatory optional optional optional CT CT CT CT CT Investigators Clinical trial sites Dr

  15. Slide 15: Esophageal cancer: Investigator-led clinical research

    Esophageal cancer：Investigator-led clinical research 6 CR in 10 cases: interim data presented at JSGCT 2017 and JSMO 2017 Radiation therapy 5 times/week (Mon- Fri) x 6 weeks Day 1 Day 4 Day 18 Day 32 Toshiyoshi Fujiwara, M.D., Ph.D. Professor & Chairman JSGCT: Japan Society of Gene and Cell Therapy

  16. Slide 16: Esophageal cancer: Phase I

    Esophageal cancer：Phase I 1. FPI in Okayama University Hospital (7 July) 2. Kick-off meeting with key investigators (15 July) Interim data from clinical research by Okayama University Dose Case Age Stage Response 001 82 cStage I CR 002 85 cStage I CR Level 1 003 92 cStage II PR 1x1010vp 004 68 cStag

  17. Slide 17: HCC: Phase I/II in Taiwan and Korea

    HCC：Phase I/II in Taiwan and Korea 1. Cohort 4 administration completed 2. Cohort 5 multiple administration(2 x 1012vp x 3) started Liver Areas for injection are monitored Directly injected to by use of sonogram. cancer cells Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved. 17

  18. Slide 18: Telomelysin: Development status

    Telomelysin: Development status Clinical Research 10 patients enrolled（C３started） Phase 1 With radiation FPI Investigator-led clinical trial With pembrolizmab CTN submitted Esophageal cancer Phase 2a FPI Phase 2b CPI combination in preparation Melanoma Phase 1/2 C5 started Phase 2 CPI combination un

  19. Slide 19: Jiangsu Hengrui

    Jiangsu Hengrui  GMP tech-transfer of Telomelysin in progress  GMP facilities for virus production under plan CFDA to ease rules: acceptance of clinical trial data collected overseas is on the table Jiangsu Hengrui Medicine（江蘇恒瑞医薬股份有限公司） Jiangsu, China Sales: approx. JPY180 Bn Employees: approx. 1

  20. Slide 20: Revised strategic alliance agreement with Medigen

    Revised strategic alliance agreement with Medigen Melanoma Esophageal cancer Expanded cost-split HCC agreement HCC CMC/GMP Constant cost saving on Telomelysin-related R&D expenses Listed on Taiwan Stock Exchange（3176） HQ: Taipei, Taiwan Representative: Stanley Chang, CEO Copyright(C) 2017, Oncolys B

  21. Slide 21: Telomelysin: what's next?

    Telomelysin: what’s next? Copyright(C) 2017 , Oncolys BioPharma Inc. All rights reserved.

  22. Slide 22: Esophageal cancer treatment perspectives in Japan

    Esophageal cancer treatment perspectives in Japan  Number of patients: approx. 31,000 in 2014  Estimated incidence: approx. 22,000 between 2015 - 2019 (Incidence worldwide: approx. 456,000 in 2012) Stage Ⅰ・Ⅱ・Ⅲ･Ⅳ ＋ Post-operative CPI Operation applicable Stage Ⅰ・Ⅱ・Ⅲ Application for Sakigake Designa

  23. Slide 23: Next Generation Telomelysin: concept (1)

    Next Generation Telomelysin: concept (1)  Regionally administrable/ abscopal effect  Good tolerability  Established GMP/QC Next Generation  Further immunity enhancing effect  Intravenously injectable  Stable at 4oC ＜Next Generation candidates examples＞ Enhancer New fiber OBP-170X D OX-40L F OB

  24. Slide 24: Next Generation Telomelysin: concept (2)

    Next Generation Telomelysin: concept (2) 1. A specific gene inserted in NG Telomelysin is delivered to a tumor cell. 2. Target molecule is expressed on the tumor cell surface. 3. Replication of NG Telomelysin and an adjunctively used tumor antibody induce stronger anti-tumor activities. Targets OX40

  25. Slide 25: Next generation Telomelysin: concept (3)

    Next generation Telomelysin: concept (3) OX-40L Tumor Infiltrating lymphocytes (TIL) Next G. T-cell‘s tumor killing 4-1BBL capability gets enhanced Infect/replicate/kill tumor cells Attack metastatic cancer cells Primary cancer cells Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved. Met

  26. Slide 26: Table of Contents

    Table of Contents 1. Financial results and future outlook 2. Telomelysin 3. TelomeScan 4. OBP-AI-004 5. Zika vaccine Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved.

  27. Slide 27: TelomeScan overview

    TelomeScan overview TelomeScan is a gene-modified adenovirus which replicates and express GFP when infected to telomerase activity-positive tumor cells. hTERTp IRES CMVp E1A E1B GFP ⊿E1 ⊿E3 Normal cell Adenovirus Type-5 Genome Telomerase activity - TeｌomeScan (OBP-401) TelomeScan Infection Fluoresce

  28. Slide 28: Possible application for liquid biopsies

    Possible application for liquid biopsies PTC * Osaka University gastric & pancreatic cancer Okayama University *PTC；Peritoneal Tumor Cell CTC Lung & Juntendo University prostate cancer Application for companion diagnostics Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved. 28

  29. Slide 29: PTC: collaborative project with Osaka University

    PTC: collaborative project with Osaka University Pancreatic cancer peritoneal washing cytology (PWC) Pancreatic cancer case PWC （+） （-） TelomeScan TelomeScan （+） （-） （+） （-） Peritoneal and Regional liver metastases recurrence possibility possibility ⇒ Intraperitoneal chemotherapy Copyright(C) 2017,

  30. Slide 30: Business development outlook

    Business development outlook Europe and China N. America in 2015 Corporate businesses & academic institutions License agreement Korea in 2014 BD activities in progress Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved. 30

  31. Slide 31: Table of Contents

    Table of Contents 1. Financial results and future outlook 2. Telomelysin 3. TelomeScan 4. OBP-AI-004 5. Zika vaccine Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved.

  32. Slide 32: Hepatitis B (HBV)

    Hepatitis B (HBV）  HBV is a member of the small DNA virus.  Its DNA considered to activate tumor DNA within infected liver cells Transmission Chronic Hepatitis B Cirrhosis HCC 10％ of HBV transmission leads to HCC In the world, 350 million patients have persistent HBV infection - Of which 70％ are i

  33. Slide 33: Long-term goal of HBV treatment: HBsAg elimination

    Long-term goal of HBV treatment: HBsAg elimination The Japan Society of Hepatology’s official guidelines for Hepatitis B treatment sets the elimination of HBs antigen (HBsAg) as a long-term goal.  Chronic hepatic failure has a obvious risk factor associated with HCC incidence.  Persistent HBV infe

  34. Slide 34: Table of Contents

    Table of Contents 1. Financial results and future outlook 2. Telomelysin 3. TelomeScan 4. OBP-AI-004 5. Zika vaccine Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved.

  35. Slide 35: Investment in Washington University biotech venture

    Investment in Washington University biotech venture Investment agreement with Precision Virologics signed in March 2017, to enhance OBP’s infectious disease pipeline and for broader business opportunity. ＜Emerging infectious diseases＞ Zika ① Modified adenovirus Chikungunya ② Camelid antibodies Dendr

  36. Slide 36: Potential Market for Zika Virus Vaccines

    Potential Market for Zika Virus Vaccines Zika transmission has been identified in 84 countries and regions in total so far.*1 Zika virus transmission through the mosquito bite *1 World Health Organization Women of reproductive age needs vaccination 3.38 Billion （Total population of Zika-affected cou

  37. Slide 37: Thank you!

    Thank you! 37 Copyright(C) 2017, Oncolys BioPharma Inc. All rights reserved.

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