Oncolys Biopharma, Inc. · TSE:4588
Oncolys Biopharma — Shareholder Meeting (March 2018)
52 slides from Oncolys Biopharma's shareholder meeting presentation, Mar 29, 2018
Slide 1: General Shareholders Meeting 2018 Company Presentation
General Shareholders Meeting 2018 Company Presentation March 29, 2018 Oncolys BioPharma Inc. (TSE mothers: 4588) Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved.
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
Slide 3: Table of Contents
Table of Contents 1. About Oncolys 2. Pipeline & Business Overview 3. Message to investors Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved.
Slide 4: Company profile
Company profile Oncolys BioPharma Oncolys Bio Pharma Address 4-1-28 Toranomon, Minato-ku, Tokyo, Japan Foundation March 18, 2004 Ticker & Market 4588（listed on December 6, 2013） President & CEO Yasuo URATA Capital 5802 Million (December 31, 2017） Employees 29（December 31 2017） Copyright(C) 2018, Onc
Slide 5: Founder profile
Founder profile 1983 Ono Pharmaceutical Co., Ltd. - Clinical project leader mainly for CVS and CNS 1994 Japan Tobacco Inc. (JT) 2002 Director of R&D Planning, JT - Innovative HIV drug, Viracept (Agouron), GVAX (Cell Genesys) and Cancer vaccine project (Corixa) 2004 Established Oncolys BioPharma Inc.
Slide 6: Business concept: Powering Future Oncotherapy
Business concept “Powering Future Oncotherapy” Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 6
Slide 7: Our pipeline: oncolytic virotherapy platform
Our pipeline: oncolytic virotherapy platform 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 Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 7
Slide 8: Management goal
Management goal Our goal is to bring our innovative biopharmaceutical candidates from Japan to the world. In-house development Licensing & launch Licensing Cancer Diagnostics ① Upfront payment ② Milestone fees ③ Royalties, etc. Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 8
Slide 9: FY2017: achievements and status
FY2017: achievements and status ＜R&D-related＞ 1. Melanoma P2 Started 2. Esophageal cancer P1 Started OBP-301 3. HCC P1/2 Multiple administration (Cohort 5) in progress “Telomelysin®” 4. Solid tumors, with PD-1 P1/2 Started 5. Esophageal caner (USA) Scientific Advisory Board（SAB) meeting 6. 9 confere
Slide 10: Financial year ending December 2018 full year forecast
Financial year ending December 2018 full year forecast (JPY: million) Sales OP CP NP R&D and SG&A Forecast FY2018 230 △1,400 △1,400 △1,400 1,6bn Results FY2017 229 △1,078 △1,087 △1,090 yoy +1 -322 -313 -310 500 0 400 -300 0,7bn 300 -600 230 200 -900 SG&A 100 -1,400 -1,200 R&D 0 -1,500 (forecast) (単位
Slide 11: Table of Contents
Table of Contents 1. About Oncolys 2. Pipeline & Business Overview 3. Message to investors Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved.
Slide 12: Developmental pipeline
Developmental pipeline Pharmaceuticals Pre- Project Indication Exploratory Phase Ⅰ Phase Ⅱ Phase Ⅲ clinical Melanoma Esophageal Oncolytic cancer virus HCC OBP-702 Solid tumor Small Solid tumor molecule OBP-801 Ophthalmic use Anti OBP-601 HIV virus OBP-AI-004 HBV Diagnostics Category Pipeline/Project
Slide 13: Oncolytic virus immunotherapy
Oncolytic virus immunotherapy 1. Local/regional injection 2. May be effective on metastatic cancer cells 3. No hair loss / nausea 4. Possibility of cancer treatment without operation Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 13
Slide 14: Virotherapy for cancer: a brief history
Virotherapy for cancer: a brief history Regression of Burkitt’s Lymphoma in association with Measles Infection World’s first oncolytic virus approved by FDA Bluming AZ, and Ziegler JL 27 October 2015 Lancet, 2 (7715):105-106, 1971 1912 Attenuated rabies virus Uterine cervical cancer DePace et al. 19
Slide 15: Telomelysin: mechanism
Telomelysin：mechanism 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 Day 0 Day 14 D
Slide 16: Telomelysin project
Telomelysin project Tumor type Treatment Country Pre-clinical Phase Ⅰ Phase Ⅱ Phase Ⅲ Radiation OBP sponsored clinical trial Esophageal Radiation Investigator initiated JP Cancer clinical trial Anti PD-1 Investigator initiated clinical research Melanoma Monotherapy US Taiwan HCC Monotherapy Korea HN
Slide 17: Esophageal Cancer: A cure without operation
Esophageal Cancer “A cure without operation” Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved.
Slide 18: Esophageal cancer overview
Esophageal cancer overview Number of cancer death worldwide (Number of patients) <Esophageal cancer treatment without operation> 1 Lung 1,590,000 2 Liver 780,000 ①Radiotherapy for inoperable patients 3 Stomach 720,000 →Unmet Medical Needs 4 Colorectal 690,000 5 Breast 520,000 ②Combination with radio
Slide 19: Investigator-initiated clinical research with radiation
Investigator-initiated clinical research with radiation 6 CR in 10 cases 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 Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dent
Slide 20: Oncolys' Phase I clinical trial with radiation
Oncolys’ Phase I clinical trial with radiation Clinical trial is in progress in Okayama University and NCCHE. 1. Phase I completion expected within 2018 2. Preparation for Phase II/III for Radiation + Telomelysin Multicenter trial in Japan Preliminary consultation with PMDA Trial expected to s
Slide 21: Scientific advisory board meeting
Scientific advisory board meeting Discussion on expanded indication of Telomelysin(20 Jan) Name Specialty Institution Weill Cornell Medicine/ Manish Shah, MD Medical Oncology NewYork-Presbyterian Memorial Sloan Kettering David Ilson, MD, PhD Medical Oncology Cancer Center Khaldoun Almhanna, MD Medic
Slide 22: Esophageal cancer treatment perspectives
Esophageal cancer treatment perspectives Number of patients: approx. 31,000 in 2014 Estimated incidence: approx. 22,000 between 2015 - 2019 (Incidence worldwide: approx. 456,000 in 2012) (Incidence USA: approx. 17,000 in 2017 ) Stage Ⅳ Metastasis/operation inapplicable patients ＋ Stage Ⅰ・Ⅱ・Ⅲ ICI
Slide 23: Melanoma: Enhancing tumor immunity
Melanoma “Enhancing tumor immunity” Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved.
Slide 24: Melanoma overview
Melanoma overview Melanoma incidence worldwide in 2012 Total:231,000 cases 28,000 欧州 Europe 6,000 北米 N. America アジア Asia 22,000 1. Most cases are curable if surgically-treated early. 100,000 アフリカ Africa その他 2. Prone to metastasis →Brain, lung, liver Others 75,000 3. Median survival of terminal stage
Slide 25: US Phase I: tumor size reduced in 7/22 patients
US Phase I: tumor size reduced in 7/22 patients Before administration After 4 weeks American, Female in 50s, melanoma with metastasis to left femoral area 25mmx8mm 33mmx16mm (↓33.4%) Solid tumor patients who have no other treatment 1. choices participated in this clinical trial. Tumor shrinkage was
Slide 26: Phase II in progress in the US
Phase Ⅱ in progress in the US Investigators Clinical trial sites Dr. Eric Whitman Atlantic Health Systems Dr. Robert Andtbacka Huntsman Cancer Institute Dr. Mohammed Milhem University of Iowa Dr. Sanjiv Agarwala St. Luke's University Health Network Inc. Dr. Sunil Reddy Stanford University Unresecta
Slide 27: Hepatocellular Cancer (HCC): Challenge to refractory cancer
Hepatocellular Cancer (HCC) “Challenge to refractory cancer” Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved.
Slide 28: HCC overview
HCC overview HBV/HCV Chronic Hepatic HCC infection Hepatitis Cirrhosis Number of cancer death worldwide HCC incidence worldwide Common treatment options 1 Lung 1,590,000 Total:782,000 cases 33,000 1.Surgery/resection 2 Liver 780,000 33,000 59,000 アジア 2.Embolization/ablation Asia 3 Stomach 720,000 63
Slide 29: HCC: Phase I/II in Taiwan/Korea
HCC: Phase I/II in Taiwan/Korea (1) Max dose（Cohort4）administration completed 1 & multiple administration（Cohort5）in progress Decide injection location Directly injected to tumor cell using ultrasonograph Expected to advance to Phase Ⅱ soon, as 2 monotherapy or in combination with CPI National Pusan
Slide 30: Telomelysin project picture after 2020
Telomelysin project picture after 2020 Tumor type Treatment Country Pre-clinical Phase Ⅰ Phase Ⅱ Phase Ⅲ Radiation Anti PD-1 Investigator initiated clinical trial JP Complete Radiation Esophageal Investigator initiated Complete clinical research Cancer ICI US CRT Monotherapy Taiwan HCC Korea ICI Mon
Slide 31: Next Generation Telomelysin
Next Generation Telomelysin Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved.
Slide 32: Next generation Telomelysin
Next generation Telomelysin NG Telomelysin T cell Immunotherapy T Lymphocyte Co-stimulate molecule Cancer cell PD-L1 CPI PD-1 Cancer cell Oncolytic virus Virus particle Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 32
Slide 33: Telomelysin platform
Telomelysin platform Telomelysin • Local administration Telomelysin • Indirectly enhance immunity • Weaker proliferative capacity OBP-702 OBP-702 with stroma cells p53 Next Generation Telomelysin A lymphocyte CP • Local/intravenous p- stimulation suppressor Telomelysin E1 Next Generation administrat
Slide 34: Business Development Activities
Business Development Activities 34 Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved.
Slide 35: Jiangsu Hengrui Medicine
Jiangsu Hengrui Medicine GMP manufacturing started in China CFDA announcement for acceptance of overseas data（8 Oct 2017） Jiangsu Hengrui Medicine（江蘇恒瑞医薬股份有限公司） Sales: JPY180 bn（FY2016） Number of employees: 13,000 <Market cap comparison table: major Japanese pharmaceutical companies> Name Market cap
Slide 36: Revised strategic alliance with Medigen
Revised strategic alliance with Medigen Melanoma Esophageal cancer Extended co-development HCC HCC CMC/GMP Steady cost reduction for R&D Medigen Biotechnology Corp. Taiwan Stock Exchange（3176） HQ：Taipei, Taiwan Stanley Chang, CEO Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 36
Slide 37: Broaden cancer treatment options
“Broaden cancer treatment options” 37 Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved.
Slide 38: TelomeScan overview
TelomeScan overview Normal cell Telomerase activity - Infection Tumor cell Fluorescent emission by GFP Telomerase activity + GFP TelomeScan 1. Express GFP when infected to CTCs 2. Detect “live” malignant tumor 3. May be used to decide treatment/medication options after surgery Copyright(C) 2018, Onc
Slide 39: Tumor Metastasis and CTC Phenotype
Tumor Metastasis and CTC Phenotype 1. Detection rate using tumor diagnostic markers currently available is around 30-40% 2. PET and MRI only detect tumor cells bigger than 1㎝ 3. CTCs seep from tumor cells undetectable by PET and MRI Primary tumor Hematogenous translocation EMT CTC Metastasis/ Vascul
Slide 40: Detecting invisible tumor cells
Detecting invisible tumor cells Tumor size ・Tumor marker ・Diagnostic imaging Surgery Radiotherapy Chemotherapy Metastasis/ Recurrence 0.5～1cm Recurrence- Invisible CT/MRI/Marker free/cure tumor Primary tumor Time Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 40
Slide 41: CTCs detected by TelomeScan
CTCs detected by TelomeScan Immunostaining GFP Tumor type (TelomeScan) CD45 Phenotyping Composite Bright-field Vimentin Lung Mesenchymal CTC Cytokeratin Prostate Cytokeratin Ovary Cytokeratin Breast Epithelial CTC Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 41
Slide 42: Application to precision medicine: NSCLC
Application to precision medicine ＜NSCLC＞ Project led by University of Pennsylvania CTC CTC CTC CTC CTC CTC CTC CTC CTC CTC CTC Chemoradiation therapy（CRT） Recurrence 5weeks Treatment continued Gene analysis Selection of treatment （ # of CTC Treatment complete Follow-up ） Copyright(C) 2018, Oncolys
Slide 43: HPV Detected in Cancer Cell
HPV Detected in Cancer Cell HPV is the cause of Cancer Cervical Cancer 1, 2 ~100% Vaginal HPV Cancer 1 60~90% Head & Neck Cancer 2 12~70% HPV is NOT detected in Blood Stream, but in ONLY CTC 1; Braaten KP et al. Rev Obstet Gynecol. (2008) 2; IARC. IARC monographs on the evaluation of carcinogenic ri
Slide 44: HPV Typing in CTCs
HPV Typing in CTCs Cervical Cancer < Sensitivity > < HPV Typing in CTCs > (≥1 cell/7.5ml of peripheral blood tested positive) 100 HPV type # Stage CTC positive rate (%) CTC Primary 80 2 IIA 16 16 60 39.0% 4 recurrence undetected 33 (16/41) 40 5 IB1 16 16 6 IB1 16 16 20 10 recurrence 16 16 0 Total 16
Slide 45: Joint research towards the practical use
Joint research towards the practical use Joint research with Division of Respiratory Medicine, Juntendo University since Nov. 2017 Juntendo promotes it as a cross-sectional research project joined by medical doctors in wide range of oncology-related fields. Juntendo Oncolys University Biopharma
Slide 46: Next step
Next step Non-Japanese corporates N. America, 2015 Japanese corporates and academia Licensed Korea, 2014 Licensing/collaboration activities Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 46
Slide 47: Table of Contents
Table of Contents 1. About Oncolys 2. Pipeline & Business Overview 3. Message to investors Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved.
Slide 48: Our US base accelerates BD/RD activities in the US
Our US base accelerates BD/RD activities in the US New Jersey Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 48
Slide 49: Further Growth & Business Expansion
Oncolys’ financial grounds in mid-long term Further Growth & Business Expansion More license agreements New pipeline Next generation Telomelysin Stronger financial OBP-XXXX OBP-YYYY grounds New license agreements Milestone fees & virus sales based on current license agreements Jiangsu Hengrui, W
Slide 50: Recent oncolytic virus deals in the world
Recent oncolytic virus deals in the world Pipeline Licensee Licenser Type Deal size T-VEC Licensing BioVex Amgen JPY 110bn （Imlygic®） (Acquisition） Licensing CAVATAK® (CVA21) Viralytics Merck JPY 42.3bn (Acquisition) Licensing/ JPY 103bn NG-348 PsiOxus Therapeutics Bristol-Myers Squibb Co-developmen
Slide 51: Again, our business concept
Again, our business concept “Powering Future Oncotherapy” Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 51
Slide 52: Thank you!
Thank you! 52 Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved.