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General Shareholders Meeting 2018 Company Presentation

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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. 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 by use of words such as "strategy," "expects," "plans," "anticipates," "believes," "will," "continues," "estimates," "intends," "projects," "goals," "targets" and other words of similar meaning. These risks and uncertainties include, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development, clinical research, seeking regulatory approval and product commercialization, as well as the impact of competitive products, patents, product liability and third-party reimbursement risks associated with the pharmaceutical industry, and the other risks and uncertainties. • Product development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Success in preclinical and early clinical trials does not ensure that later stage or large scale clinical trials will be successful. Many important factors affect Oncolys BioPharma’s ability to successfully develop and commercialize drugs, including the ability to secure necessary funding, to obtain and maintain necessary patents and licenses, to demonstrate safety and/or efficacy of drug candidates at each stage of the clinical trial process, to overcome technical hurdles that may arise, to meet applicable regulatory standards, to receive required regulatory approvals, to be capable of producing drug candidates in commercial quantities at reasonable costs, to compete successfully against other products and to market products successfully. There can be no assurance Oncolys BioPharma will be successful in its efforts to develop and commercialize new products. • No guarantee is made as to the accuracy, completeness or timeliness of any information, projections or opinions contained in this presentation material or upon which any such projections or opinions have been based. The information contained in this presentation material is compiled for information purpose only and does not constitute an offer or solicitation to purchase or sell any of the securities in this presentation material. • This presentation material is a summary translation of the original published in Japanese. In case of any discrepancy, the Japanese original shall prevail. Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 2 Table of Contents 1. About Oncolys 2. Pipeline & Business Overview 3. Message to investors Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 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 & Yasuo URATA CEO Capital 5802 Million (December 31, 2017） Employees 29（December 31 2017） Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 4 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. in Tokyo, Japan 2009 Member of Bio Innovation Research Society (Ministry of Economy, Trade and Industry of Japan) 2016 Executive Officer, Oncolys USA Inc. President & CEO Yasuo URATA Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 5 Business concept “Powering Future Oncotherapy” Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 6 Our pipeline: oncolytic virotherapy platform Oncolytic virotherapy platform Systemic treatment Prognosis follow-up Regional treatment O N OH H HN S O S NH O Early detection O O OBP-702 OBP-405 Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 7 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 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 conference presentations, 4 publications ＜Business-related＞ 1. Milestone fee from Hengrui 2. Co-Development fund from Medigen 1. PTC feasibility study for pancreatic cancer: IRB Cancer Diagnosis 2. Joint research agreement with Juntendo University 3. SAB for NSCLC 4. 9 conference presentations, 3 publications 1. Solid tumor Phase 1 Cohort 3 in progress OBP-801 2. Possibility of 2wks sustained delivery explored Epigenetic cancer treatment 3. Pre-clinical study with Kyoto Prefectural University of Medicine extending the application into ophthalmologic field AI-004 1. Compound screening at Kagoshima University in progress Novel HBV drug Others 1. Completed 1.4 bn JPY financing by third-party allotment Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 9 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 300 230 -600 200 -900 SG&A R&D 100 -1,400 -1,200 0 -1,500 (forecast) (単位：百万円) FY2012 FY2013 FY2014 FY2015 FY2016 FY2017 FY2018 forcast SG&A (JPY 100 million) Sales OP 10 Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. Table of Contents 1. About Oncolys 2. Pipeline & Business Overview 3. Message to investors Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. Developmental pipeline Pharmaceuticals Pre- Phase Ⅰ Phase Ⅱ Phase Ⅲ Project Indication Exploratory 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 Indication Basic Research Clinical Study Clinical Usefulness Tumor Solid tumor diagnostics virus Oncolytic Oncolytic OBP-401/1101 Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 12 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 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. 1922 Vaccinia virus, NDV Ascitis tumors (mouse) Levaditi & Nicolau 1950 Attenuated rabies vaccine Melanoma Pack 1952 Myxo, paramyxo, arbovirus Various tumors Southam et al. 1957 Coxsackie B Various tumors Suskind et al. 1965 NDV Ascitis tumors (mouse) Cassel et al. 1974 Mumps Various tumors Asada Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 14 Telomelysin：mechanism Normal cell (Telomerase activity－） No replication No cytophathy Induced cell death Cancer cell Replication of and diffusion of Telomelysin Telomelysin (Telomerase activity+) Ref.) The Lancet Oncology Vol. 3 Jan. 2002 Colorectal （15 days after administration） Lung Day 0 Day 14 Day 28 cancer cancer Control group Telomelysin Control group Telomelysin Ref) Curr. Cancer Drug Targets, 7: 191-201, 2007 ) Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 15 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 HNSCC Radiation JP Planning Sarcoma Radiation JP ※Jiangsu Hengrui’s project is not included in this table. ) Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 16 Esophageal Cancer “A cure without operation” Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 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 radiochemotherapy Esophageal before operation 6 400,000 cancer →Adjuvant therapy Ref: WHO 2012 research ③Combination with immunotherapy Esophageal cancer incidence worldwide Total:456,000 cases (anti-PD-1 antibodies) 13,000 24,000 26,000 アジアAsia 53,000 欧州Europe アフリカAfrica Radiation 北米N. America 340,000 その他Others Ref: 2012 IARC data Copyright(C) 2018, Oncolys BioPharma Inc. All rights reserved. 18 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,
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