Cellestia Biotech AG - Company Presentation

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Presentation transcript:

Cellestia Biotech AG - Company Presentation First-in-class Pan-NOTCH inhibitor for anti-cancer Therapy March 2016

Cellestia Biotech AG (S.A.): Company History & Profile Spin-off from Swiss Institute for Experimental Cancer Research at EPFL, Lausanne, Switzerland Incorporation May 2014 by Prof. F. Radtke and R. Lehal Co-founding Development Team joined September 2015 adding management & pharma development expertise Headquarter & Development Office at Technology Park, Basel; Research continues at EPFL, Lausanne Worldwide exclusive License Agreement on IP from EPFL TTO in June 2014, US Patent granted 3/2016 SEED Financing A successfully closed, SEED B ongoing, Series A target in 4Q2016 / 1Q2017 Development activities ongoing (e.g. manufacture, IND/CTA enabling studies) Target to reach clinical development Ph I by 1Q2017 Cellestia Biotech Offices: Innovation Square EPFL Building C CH-1015 Lausanne, Switzerland Hochbergerstrasse 60C CH-4057 Basel, Switzerland www.cellestiabiotech.com

Cellestia Biotech S.A. Management: Decades of Experience in R&D Dr. Michael Bauer CEO Prof. Freddy Radtke Chairman BoD Dr. Rajwinder Lehal CSO Dr. Dirk Weber CMO Dr. Richard Peck Regulatory Affairs Professional and Experienced Management Team Scientific Excellence at EPFL Research (Prof. Freddy Radtke & Rajwinder Lehal, PhD) Drug Development Expertise from Biotech and Big Pharma (Michael Bauer, PhD) Medical Oncology Development and Medical Affairs Experience (Dirk Weber, MD, PhD) Global Regulatory Affairs Experience (Richard Peck, PhD) Track record of professional success and achievements Over 100 scientific papers in leading journals, invited speaker at top conferences Successful leadership bringing products into clinic, achieving clinical proof of concept, gaining product registrations and successful commercial launch

Advisory Boards: Business, Institutional, Scientific & Medical Business Advisors: ROGER MEIER Clarena AG, Corporate Development and Private Equity Facilitation CHRISTOPH RENTSCH CFO at Santhera AG, Strategic Finance and designated member of the BoD RALF ROSENOW Blum & Grob, Attorneys at Law Ltd, General Legal Counsel URS BREITENSTEIN Hoffmann & Co, Financial Services (payroll, tax and accounting) ANDREAS SCHÖLLHORN LS Partners, Basel; Intellectual property Institutional Support: EPFL, Lausanne Research & Development I-NET INNOVATION NETWORKS, Basel INNOVATION PARK, EPFL Lausanne INNOVAUD Canton of Vaud, Lausanne SERVICE DE LA PROMOTION ECONOMIQUE &COMMERCE (SPECo), VAUD KOMMISSION FUR TECHNOLOGIE UND INNOVATION (KTI), Bern) Financing R&D Scientific Advisory Board: DR. DORIANO FABBRO Preclinical Pharmacology, Basel DR. MARC LANG Medicinal Chemistry, Basel DR. ROBERT ETTLIN Toxicology, Basel PROF. CHANTAL CSAJKA PK/ADME, Lausanne DR. PAOLO NUCIFORO Head Molecular Oncology Group, Vall d`Hebron, Barcelona Medical Advisory Board: PROF. RICHARD HERRMANN Medical Oncology, Basel PROF. JAVIER CORTES Medical Oncology; Vall d`Hebron, Barcelona PROF. JOSEP TABERNERO Head Med Oncology Department & Director Vall d’Hebron Institute of Oncology (VHIO) PROF. FRANCESC BOSCH ALBAREDA Head Hematology Department, Vall d`Hebron, Barcelona PROF. MARTIN DREYLING Medical Hemato-Oncology, LMU Munich Cellestia has been very successful in attracting internationally recognized experts in business, preclinical and clinical research and development

What is NOTCH ? Cell-to-Cell communication mechanism of physically directly adjacent cells Cancer Growth, Metastasis, Invasion, Blood vessel formation, Cancer Stem Cells constitutive activation Signal Sending Cell: „Ligand“  5 NOTCH activating ligands DLL1, DLL3, DLL4 JAG1, JAG2 Signal Receiving Cell: „Receptor“  4 NOTCH receptors NOTCH 1-2-3-4 Gamma Secretase CB-103 on / off Signal Translation: „NICD“ triggers transcription in cell nucleus Selective Effect: „downstream“ proteins produced due to NOTCH activation: Driving cancer if out of control Adopted from : Andersson & Lendahl Nature Reviews Drug Discovery, MAY 2014; VOLUME 13

New Mode of Action: Central control of NOTCH driven cancer Why is CB-103 unique? New Mode of Action: Central control of NOTCH driven cancer constitutive activation Adopted from : Andersson & Lendahl Nature Reviews Drug Discovery, MAY 2014; VOLUME 13 Competitor products: 1. Inhibitors of activating ligands: 2. Inhibitors of NOTCH receptors: 3. Gamma-secretase inhibitors: Central Control: blocking NOTCH regardless of mechanistic cause Proliferation Resistance to Cell Death Angiogenesis  Incomplete control Invasion Metastasis STOP Cancer Stem Cells

Clinical Relevance & Validation: Patients´ life expectance depends on NOTCH status Breast Cancer (BC): High level co-expression of JAG1 and NOTCH1 Associated with poor survival (median OS): High NOTCH1: 40 mths Low NOTCH1: 83 mths Reedjik et al. Cancer Research 2005 Low NOTCH1 High NOTCH1 Significantly shorter survival for patients with upregulated NOTCH activation NOTCH is a clinically validated target – anti NOTCH drugs show clinical efficacy

Is CB-103 active against cancer? TNBC: Triple Negative Breast Cancer, patient derived, GSI resistant (constitutive activation, no competitor) Clear Disease Control Confirmed down-regulation of pathway biomarkers Well tolerated daily treatments

Is CB-103 active against cancer? T-ALL: Acute Lymphocytic T-Cell Leukaemia, patient derived blood sample, resistant to chemo & experimental therapies Toxic conc. of CB-103 Selective killing of leukemic cells in NOTCH positive disease Synergy in chemo-combination Survival benefit (mouse model) Well tolerated daily treatments

CB-103: Development Plan, Financing & Valuation Inflection Points CHF 0.5 m Seed A financing completed non-GMP manufacture established, ready for GMP manufacture, formulation development started Toxicology studies have been initiated CHF 3.295 m Seed B financing round open: GMP manufacture, GLP tox and IND filing for Phase I

TOP NOTCH Investment Rationale People: Top Team with professional track record Patent: Exclusive License on IP; US granted Product: CB-103 is first and potentially best-in class Control NOTCH independent of the cause, access largest possible patient pool CB-103 has a good safety profile in toxicity profiling and animal studies thus far Very attractive target pursued by big pharma, attractive deal market for profitable exit Clinically validated and relevant target with first proof of concept observed Expect excellent margins : Small molecule, easy and cost – effective to produce Medical Need & Market Potential: Over 250´000 newly diagnosed patients with NOTCH activation in various indications diagnosed annually, with currently no targeted treatment Market potential > 10 billion Cellestia sales projections for CB-103 reaching CHF 1bn peak sales Increased chance of success by combining with companion diagnostic

For more information contact: Michael Bauer, CEO Cellestia Biotech AG Hochbergerstrasse 60C 4057 Basel, Switzerland Phone: +41 61 633 2980 Mobile: +49 151 6160 9295 Email: michael.bauer@cellestiabiotech.com www.cellestiabiotech.com Cellestia Biotech Research: Innovation Square, EPFL Building C 1015 Lausanne, Switzerland Phone: +4121 693 0771 and 0774