Cancer and Autoimmune Diseases
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Cancer and Autoimmune Diseases We are armed to fight Forward Looking Statement This presentation contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics’ management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This presentation includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 26 April 2019 including the 2018 Financial results, all available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this presentation at the date hereof and does not undertake any obligation to update or revise the forward- looking information or statements. This presentation does not constitute an offer to sell the shares or soliciting an offer to purchase any of the Shares to any person in any jurisdiction where such an offer or solicitation is not permitted. The Shares may not be offered or sold, directly or indirectly, may be distributed or sent to any person or into any jurisdiction, except in circumstances that will result in the compliance with all applicable laws and regulations. Persons into whose possession this presentation may come are required to inform themselves about, and to observe all, such restrictions. The Company accept no responsibility for any violation by any person, whether or not it is a prospective purchaser of Shares, of any such restriction. The information contained in this presentation has not been independently verified and no commitment, representation or warranty, express or implied, is given by the Company or anyone of its directors, officers or respective affiliates or any other person and may not serve as the basis for the veracity, completeness, accuracy or completeness of the information contained in this document (or for any omission of any information in this presentation) or any other information relating to the Company or its affiliates. The information contained in this document is provided only as of the date of this document and may be subject to update, supplement, revision, verification and modification. They can be modified significantly. The Company is not subject to an obligation to update the information contained in this document and any opinion expressed in this document is subject to change without notice. The Company, its advisers, its representatives cannot be held responsible in any manner whatsoever for any loss of any nature whatsoever resulting from the use of this document or its contents or otherwise related in any way to this document. This document contains information relating to the Company's markets and the positioning of the Company in these markets. This information is derived from various sources and estimates of the Company. Investors cannot rely on this information to make their investment decision. 3 OSE Immunotherapeutics Company Overview OSE’s Technological Platform: From Target Identification to Product Validation and Beyond An integrated operational immunology research platform Intertwined with academic research Common locations, Founded in 2012 01 mixed team IPO in 2015 (€ 21.1m) Fully translational Constant collaboration with clinicians, Listed on EuroNext Paris, EPA ticker OSE 02 pre-clinical humanized models As of June 30, 2019 Turn over € 16m - Net profit € 0.5m Leveraging a unique experience of 25 years of clinical 03 immunology in immunotherapy cluster in Nantes Cash € 26.5m Financial visibility until end of 2020 04 Connected internationally with top academic centers 4 OSE Immunotherapeutics Investor Highlights Multiple programs in clinical stage development: Ongoing Phase 3 clinical study of Tedopi® in NSCLC patients • Non-small cell lung cancer post CKI post checkpoint inhibitor failure • Advanced pancreatic cancer • Solid tumors Interim results expected end of Q1 2020 • Ulcerative colitis and Sjögren’s syndrome • Autoimmune diseases & transplantation A potential of € 1.3Bn milestone payments through partnerships with top pharma companies: Additional first-in-class products in discovery/early clinical covering • Boehringer Ingelheim on BI 765063 immuno-oncology (myeloid checkpoints) • Servier on OSE-127 and autoimmune indications • Local partners on Tedopi® : Rafa in Israel and CKD in South Korea 5 Current Industrial Partnerships Up to € 1.3Bn in Potential Milestones + Royalties OSE-127 BI 765063 (OSE-172) Tedopi® € 10.25m Upfront payment € 15m Upfront payment € 1.2m upfront and short-term December 2016 April 2018 milestones Q1 2020 € 30m € 15m Milestone payments: CTA Phase 1 2 step option fee: Phase 2 completion UC & st Up to € 4.3m Sjögren Incl. € 10m paid upon exercise of 1st and 1 dosing of a patient option step February 2019 H1 2019 Milestone payments + Royalties on sales and a margin Up to € 272m Up to € 1.1Bn within the transfer price Milestone payments Milestone payments + Royalties on sales + Royalties on sales Up to € 1.3Bn Milestone payments + Royalties on sales 6 6 Abilities and Knowledge To Address Key Drivers of the Immune System I/O: T-cell approach I/O: New Myeloid targets I&I: New Concepts Cancer Vaccine Bispecific Macrophage Dendritic cells Immune Balance Priming Immune checkpoint Phagocytosis Ag presentation Effectors vs Regulators 7 7 OSE’s Research Pillars Transversal Biotechnologies Antibody discovery Molecular Engineering Bioproduction Bioanalytics I/O: T-cell Approach I/O: New Myeloid Targets I&I: New Concepts ▪ Selective Immune Checkpoint (CD28, SIRPg) ▪ Cancer Vaccine ▪ New Immune Checkpoint (SIRPa, CLEC-1) (Tedopi®) ▪ New Cytokine Blockade (IL-7R) ▪ Bispecific Immune Checkpoints ▪ Phagocytosis & Sensing of death (BiCKI®) ▪ Resolution of Inflammation (ChemR23) Translational Research Human 3D ‘organ’ ex-vivo platform Bio-Informatics (3D patient-derived primary tissue explant cultures) (Big Data, Target discovery/validation) 8 First-in-Class Portfolio Immuno-Oncology and Auto-Immune Diseases Pre-Clinical PROGRAM Indication Phase 1 Phase 2 Phase 3 POC IMMUNO-ONCOLOGY Tedopi® EU-US-Israel NSCLC Neoepitopes Ongoing Advanced pancreatic Combo with PD1 Tedopi® cancer Opdivo® Ongoing BI 765063 (OSE-172) Various cancers Ongoing SIRP⍺ OSE-703 Various cancers 2020 IL-7R BiCKI® Bispecific anti-PD-1 & Various cancers 2020 Innovative Targets AUTO-IMMUNE DISEASES FR104 Autoimmune diseases Phase 2 planning CD28 & Transplantation ongoing First-in-class product OSE-127 Ulcerative Colitis Positive Phase 1 2020 IL-7R Sjögren’s syndrome Results Q4 2019 9 A High Potential Clinical-Stage Biotech Key Highlights Projected catalysts that drive near term value In Phase 3 in NSCLC post-CKI – First-step results expected end of Q1 2020 Tedopi® In Phase 2 in pancreatic cancer in combination with Opdivo® in a GERCOR sponsored study BI 765063 In Phase 1 in advanced solid tumors BiCKI® A new Bi-specific platform with an anti-PD-1 backbone (proprietary) FR104 Phase 2 status in auto-immune diseases or transplant OSE-127 Phase 2 in UC (sponsor OSE) & in Sjögren’ s syndrome (sponsor Servier) expected in 2020 Progress of the portfolio OSE-703 (with MSKCC), R&D new targets A potential of € 1.3Bn milestone payments in auto-immune diseases and in immuno-oncology through partnerships with top pharmaceuticals Boehringer Ingelheim on BI 765063 . Servier on OSE-127 . Local partners on Tedopi® : Rafa in Israel and CKD in South Korea 10 First-in-Class Portfolio Immuno-Oncology Pre-Clinical PROGRAM Indication Phase 1 Phase 2 Phase 3 POC IMMUNO-ONCOLOGY EU-US-Israel Tedopi® NSCLC ongoing Combo with PD1 Advanced Tedopi® Opdivo® pancreatic cancer Ongoing Our lead product: Tedopi® • A proprietary combination of neoepitopes aimed at stimulating T-lymphocytes • Currently in Phase 3 clinical trial in advanced NSCLC post checkpoint inhibitor (CKI) failure • Results from the first step expected end of Q1 2020 • Currently in Phase 2 clinical trial in combination with CKI Opdivo® in aggressive advanced pancreatic cancer 11 Tedopi® An Alternative Approach to Cytotoxic T-Cell Activation NEOEPITOPES / HLA / TCR binding: Mandatory to activate cytotoxic T-cell response Neoepitopes: Small peptides deriving from tumor specific antigens expressed in various cancers,