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Firalis SAS

Biomarker R&D Bridging Science to Clinics May 25 th 2009 GTN IMI-JU Hüseyin FIRAT, President, CSO. Firalis SAS. Firalis at a Glance. Our Mission Creating novel values in biomarker (BM)-based diagnostics via R&D and regulatory qualification of BMs Focus of Interest

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Firalis SAS

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  1. Biomarker R&D Bridging Science to Clinics May 25th 2009 GTN IMI-JU Hüseyin FIRAT, President, CSO Firalis SAS

  2. Firalis at a Glance Our Mission Creating novel values in biomarker (BM)-based diagnostics via R&D and regulatory qualification of BMs Focus of Interest BMs of inflammatory cardiovascular diseases Two-pillar business model Servicing activities European contract approved >3 Mio € for 5 years Biomarker R&D activities Companion Diagnostic Test – IP secured Disease Biomarkers – IP secured President:Hüseyin FIRAT Legal Status:SAS founded in July 2008 Location:Huningue, South-Alsace, proximity of Basel/Switzerland Firalis Firalis proprietary information

  3. Start-up Team Management team Jean-Claude Wehrle CEO, from Sept 2009, Former CEO of NanoVivoDiagnostics Corporation Hueseyin Firat, MD, PhD, Founder President, CSO Attila Garami MD, PhD, Director of Translational BMs&IA Fidan Aras MD, Responsible for Assay Development Fuat Firat Management, responsible for Financial Affairs Béatrice Molac PhD, Director of Regulatory Affairs & PI Stella Suzan PhD, Project Manager Consultant support: Denis le Bouteiller MSc, MBA, Management Brice Suire Senior Financial Advisor Joerg Staeheli DMan, Business Strategy Advisor IMI-JU service provider Interface EuropeLandry Cochard (Bruxelles) Firalis Firalis proprietary information

  4. Servicing Activities Services offered by Firalis Strategy consulting in BM R&D,support establishment of R&D programs, from design to clinical qualification Management of BM R&D,upto the qualification of BMs. A part of experimental work is subcontracted Integrative analysis of data from clinicaland/or x-omicBM studies Development of BM assays and preclinical/clinical sample testing Meso-Scale Discovery Platform Firalis Firalis proprietary information

  5. IMI-JU (Call #2008.1.5) Firalis has created and coordinated the SAFE-T (Safer And Faster Evidence-based Translation) consortium Development of Translational Safety BMs (liver, kidneys and vascular system) Overall foreseen budget: 36 Mio € over 5 years 11 «major pharmas», 4 biotechs, 6 academic EMEA1 (as partner) and FDA2 (as advisor) Firalis 1European Medicines Agency 2Food and Drug Administration, USA 3Europeen Federation of Pharmaceutical Industry and Associations 5 Firalis proprietary information

  6. IMI-JU (Call #2008.1.5) Firalis is a major contributor to SAFE-T Initiator of the SAFE-T project and coordinator of applicant consortium Co-leading with the Industry partners 4 out of 9 Work Packages Obtained the highest EU funding among all partners Unique SME within the vascular project (budget:12 Mio €, 7 Mio € EFPIA3 contribution) Firalis 3European Federation of Pharmaceutical Industry and Associations 6 6 Firalis proprietary information

  7. Acknowledgement Firalis • Firalis team acknowledges for their support • Regional institutions • Agence Régional de l’Innovation (JJ Bernardini) • SEMIA, • OSEO Alsace, • Alsace Innovation, • Alsace Biovalley • Philippe ARHETS (INSERM) • IMI-JU service provider • Interface Europe, Bruxelles (Landry Cochard) 7 7 Firalis proprietary information

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