MediGene AG · LS:A40ESG
MediGene — 9M 2018 Earnings Presentation
19 slides from MediGene's earnings presentation, Nov 13, 2018
Slide 1: Living Immunotherapies: 9-months 2018 Earnings Call
Living Immunotherapies 9-months 2018 Earnings Call November 13, 2018 Prof. Dolores J. Schendel, CEO/CSO Dr. Kai Pinkernell, CMO/CDO
Slide 2: "Safe Harbor" Statement
"Safe Harbor" Statement All of the information herein has been prepared by the Company solely for use in this presentation. The information contained in this presentation has not been independently verified. No representation, warranty or undertaking, express or implied, is made as to, and no relian
Slide 3: Major events since the beginning of 2018
Major events since the beginning of 2018 Phase I/II trial started with TCR-T cell therapy MDG1011 TCR discovery alliance significantly expanded with bluebird bio Successful capital raise of € 32 m in oversubscribed private placement New collaboration initiated with Structured Immunity for improving
Slide 4: Granted IP to discover MHC class-II-restricted CD4+ T cells
Granted IP to discover MHC class-II-restricted CD4+ T cells supports tumor antigen and neo- antigen targeting MDG holds an exclusive license on a recently granted European Patent covering allo-restricted CD4+ T cells, obtainable by a multi-step process, for use in a method for the treatment of solid
Slide 5: Advance in TCR technologies to identify class-II-restricted CD4+ T cells
Medigene reports advance in TCR technologies to identify class-II-restricted CD4+ T cells Presentation at the Annual Neoantigen Targeted Therapies Meeting, August 18: General problem for developing CD4-based immunotherapies: Difficult to define relevant epitopes of candidate antigens that are well s
Slide 6: Expansion of TCR pipeline through licensing agreement with Leiden University
Expansion of TCR pipeline through licensing agreement with Leiden University Medigene licensed a Histocompatibility Antigen 1 (HA-1)-specific TCR from Leiden University HA-1 belongs to the group of minor Histocompatibility Antigens (mHA) The Leiden University HA-1-specific TCR was already tested in
Slide 7: HA-1: Unique opportunity to complement and advance TCR-T program
HA-1: Unique opportunity to complement and advance TCR-T clinical development program Antigen Patients TCR • HA-1 extensively • High medical need • First safety & tolerability studied in-house • Broad HA-1 expression data from IIT in Leiden • Very well defined, easily in liquid & solid tumors with f
Slide 8: Medigene's immunotherapy pipeline
Medigene’s immunotherapy pipeline INDICATION PROJECT PRECLINICAL PHASE I PHASE II (TARGET) DC vaccine Acute myeloid leukemia (WT-1 / PRAME ) TCR 1 (MDG1011) AML, MDS,MM (PRAME) TCR-IIT * Multiple myeloma (MAGE-A1) Start 2018/19e TCR 2 (HA-1) Undisclosed TCR 3 Undisclosed TABs T cell leukemias + new
Slide 9: MDG1011: First TCR-T cell therapy clinical trial
medigene MDG1011 First TCR-T cell therapy clinical trial
Slide 10: Phase I/II clinical trial of MDG1011 in myeloid and lymphoid malignancies
Phase I/II clinical trial of MDG1011 in myeloid and lymphoid malignancies Target: PRAME is a well characterized tumor antigen overexpressed in multiple hematological and solid tumor indications The drug, MDG1011: T cells expressing a HLA-A*02:01-restricted T cell receptor specific for PRAME Trial ou
Slide 11: Current status of MDG1011 Phase I/II trial
Current status of MDG1011 Phase I/II trial Amendment of trial design approved by the Paul-Ehrlich-Institut (German regulatory authority) to simplify patient enrollment: Old: 1 patient per indication per dose cohort New: At least 1 Multiple Myeloma patient and at least 1 AML or MDS patient per dose c
Slide 12: Protocol amendment approved: Inclusion criteria simplified
Protocol amendment approved: Inclusion criteria simplified for patient recruitment in Phase I Multi-center study at currently three sites (University of Regensburg, Würzburg and Erlangen, Germany) with approx. 12 patients (+3) ≥1 AML/MDS, ≥1 MM (+3) up to (+3) 5x106 cells/kg 1x107 cells/kg 1x106 cel
Slide 13: DC vaccine update
DC vaccine update Ongoing Phase I/II trial: Open-label, prospective, non-randomized trial 20 AML patients: Continuous vaccination for 2 years or until progression/ death, last patient included end of 2017 Primary objectives: feasibility and safety Secondary objectives: overall survival (OS), progres
Slide 14: Financial Report 9M-2018
medigene Financial Report 9M-2018
Slide 15: Revenue and R&D cost increased, guidance further improved
Revenue and R&D cost increased, guidance further improved Increase in R&D expenses €8.0 m Total revenues increased +20% to 13.3 m due to extension in development by 11% activities Revenues from €4.7 m +43% immunotherapies increased by 38% €76.3 m Liquid assets & time deposits €10.7 m EBITDA loss inc
Slide 16: Financial guidance 2018 further improved
Financial guidance 2018 further improved PREVIOUS UPDATED 9M GUIDANCE* GUIDANCE Total revenue €9.5-10.5 m €9.5-10.5 m R&D expenses €21-23 m €19-21 m EBITDA loss €18-20 m €16-18 m Cash usage €15-17 m €12-14 m Liquid assets as of September 30, 2018 amounted to €76.3 m Medigene expects it has sufficien
Slide 17: Outlook
Outlook MDG1011, Medigene’s first TCR trial: Start treatment of first dose cohort Medigene’s DC trial in AML: Analysis of 1-year-treatment (half of treatment period) to be presented at scientific conferences in 2019 Final read-out (2-years-treatment) expected end of 2019 HA-1 TCR: Further preclinica
Slide 18: Questions & Answers
medigene Questions & Answers 18
Slide 19: Medigene AG contact details
Medigene AG T +49 - 89 - 20 00 33 - 0 Lochhamer Straße 11 F +49 - 89 - 20 00 33 - 2920 82152 Planegg / Martinsried [email protected] Germany www.medigene.com Listed on Frankfurt Stock Exchange (MDG1, Prime Standard, TecDAX)