Slide 1: Harnessing B-Cells for Cancer Immunotherapy
ASX:IMU For personal use only v HARNESSING B-CELLS FOR CANCER IMMUNOTHERAPY Acquisition of OSU/Mayo assets and up to A$20m capital raising Leslie Chong June 2018 Not for release or distribution in the United States Managing Director & Chief Executive Officer
Slide 2: Notice: Forward Looking Statements
NOTICE: FORWARD LOOKING STATEMENTS For personal use only Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, unce
Slide 3: Executive Summary
EXECUTIVE SUMMARY For personal use only • Synergistic technology acquisition from Ohio State University (OSU) and The Mayo Clinic (Mayo): Full spectrum of indications and targets to choose from, including check point inhibitors and combination therapies • Funding: Up to A$20m capital raise to fund e
Slide 4: Capital Raising Summary
CAPITAL RAISING SUMMARY For personal use only • Imugene is conducting an up to A$20m capital raising to fully fund: - Acquisition of OSU and Mayo B-Cell Peptide IP and Clinical Portfolio; - Acceleration of combined Imugene Pipeline clinical programs; - Adaptive study for PD-1 vaccine candidate; - Ge
Slide 5: Use of Proceeds
USE OF PROCEEDS For personal use only Up to A$20m Capital Raise (funding for up to 3 years): • Acquisition of OSU B-Cell Peptide IP and Clinical Portfolio • Acceleration of combined Imugene pipeline of HER2, PD-1 and combinations of B- cell vaccine clinical programs - Completion of Phase 2 Trial for
Slide 6: Strategic Acquisition Opportunity
STRATEGIC ACQUISITION OPPORTUNITY Ohio State University and Mayo Clinic B-cell peptide vaccine portfolio For personal use only • Opportunity to create the pre-eminent, dominant position globally in B-cell peptide vaccines and therapeutics. • Professor Kaumaya’s work in the area of check-point inhibi
Slide 7: Imugene Deliverables/Milestones: Estimated Timelines
IMUGENE DELIVERABLES/MILESTONES: ESTIMATED TIMELINES - Deliverables For personal use only - Events/Value Inflection Points 2018 2019 2020 2021 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 IMUGENE • HER-Vaxx Program PHASE 1B PHASE 2 m Start Phase 2 PFS READOUT DATA READOUT OSU/MAYO OSU/MAYO ASSET ACQUIS
Slide 8: Financial Summary
FINANCIAL SUMMARY ASX:IMU Options on issue (as at May 2018) For personal use only No. of options Exercise Price Expiry Market Cap (4 June 2018): $88.5M AUD, $67M USD Listed: 242.5M $0.026 30/11/2020 (IMUOA) Ordinary Shares: 2.855 billion Unlisted: 64.5M $0.017* 12 month price range: 1.2 cents – 4.0
Slide 9: A Team with Track Record in Drug Development
A TEAM WITH TRACK RECORD IN DRUG DEVELOPMENT Leslie Chong (Sydney, Australia) Prof Ursula Wiedermann (Vienna, Austria) For personal use only Managing Director & Chief Executive Officer Chief Scientific Officer • Over 20 years of oncology experience in Phase I – III of • Co-inventor of HER-Vaxx clini
Slide 10: Imugene Scientific Advisory Board
Imugene Scientific Advisory Board Prof Christoph Zieliniski (Vienna, Austria) Prof Ursula Wiedermann (Vienna, Austria) For personal use only Head of Scientific Advisory Board Chief Scientific Officer • Chairman of the Comprehensive Cancer Centre in Vienna • Co-inventor of HER-Vaxx • Chairman of the
Slide 11: A Better Way to Make Antibodies to Treat Cancer?
A BETTER WAY TO MAKE ANTIBODIES TO TREAT CANCER? For personal use only In a facility: Using B-cells in your body VS v B-cells are cells in the human body that naturally produce millions of antibodies For example, Merck’s Keytruda Teaching B-cells to make antibodies using peptide antigens 1 1
Slide 12: B-Cell Vaccine Platform Technology
B-CELL VACCINE PLATFORM TECHNOLOGY For personal use only The B-cell vaccine platform has the potential to be part of the next wave of immuno-oncology products. It makes multi-level therapies against a combination of targets achievable. SELECTION OF ANTIGENS CREATION OF A VACCINE IMMUNIZATION ENDOGEN
Slide 13: The Inventor – Professor Pravin Kaumaya
THE INVENTOR – PROFESSOR PRAVIN KAUMAYA For personal use only • Prof of Medicine Department of Obstetric Gynecology at Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center • Expert in the fields of vaccine research with emphasis on peptide vaccines for cancer • Resea
Slide 14: Principal Investigator – Dr. Tanios Bekaii Saab
PRINCIPAL INVESTIGATOR – DR. TANIOS BEKAII SAAB For personal use only • Professor of Medicine, Mayo Clinic College of Medicine; Science Co- Leader, Gastrointestinal Cancer Program, Mayo Clinic Cancer Center • Medical Director, Cancer Clinical Research Office; Senior Associate Consultant Division of
Slide 15: Expanded Imugene B-Cell Vaccine Pipeline
EXPANDED IMUGENE B-CELL VACCINE PIPELINE Strengthens and broadens Imugene’s B-cell vaccine pipeline For personal use only CLINIC OR CLINIC READY OSU / MAYO CLINIC IMUGENE PD-1 Her-2 + Her-2 HER-Vaxx PD-1 Clinic Ready Phase 2 PD-1 Combo v Phase 1b/2 Mimotope Candidate Cancer Vaccine Proposed DISCOVER
Slide 16: Expanded Imugene Pipeline with OSU/Mayo Acquisition
EXPANDED IMUGENE PIPELINE WITH OSU/MAYO ACQUISITION Acquisition of VACCINE PRE-IND CLINICAL DEVELOPMENT For personal use only PROGRAM DISCOVERY PRE-CLINICAL CANDIDATE WORK PHASE 1 PHASE 2 clinic ready B-cell HER-Vaxx technology, with 2nd Gen. Her-2 Vaccine a full spectrum of Mimotope PD-1 indication
Slide 17: Why Select and Target PD-1 for B-Cell Vaccination?
WHY SELECT AND TARGET PD-1 FOR B-CELL VACCINATION? For personal use only Monoclonal antibody immunotherapies Whilst acknowledging the rapid rise in Keytruda® (Merck) and clinical trials involving PD-1 and their Opdivo® (BMS) targeting PD-1 sold combination with other treatments*, a PD-1 USD$3.8B and
Slide 18: PD-1 B-Cell Vaccine Candidate is Clinic Ready
PD-1 B-CELL VACCINE CANDIDATE IS CLINIC READY For personal use only • Candidate PD-1 B-cell epitope antigen identified and characterized • Actual vaccine candidate tested in preclinical immunogenicity and validated industry mouse models of cancer • Encouraging data when combined with acquired Kaumay
Slide 19: PD-1 Vaccine Phase Development Path 2018-2019
PD-1 VACCINE PHASE 1 DEVELOPMENT PATH 2018-2019 For personal use only Finalise Formal regulatory IND 2019: PD-1 CMC pre-clinical submissions Commence candidate vaccine manufacturing Phase 1 Identified May, 2018 v Proposed Adaptive Phase 1/2 Expansions Assumption PD-1 Vaccine Design Cohort 3 3-6 Indi
Slide 20: Current OSU/Mayo Phase HER-2 Study (No Chemo)
CURRENT OSU/MAYO PHASE 2 HER-2 STUDY (NO CHEMO) Phase 1 (completed) Phase 2 For personal use only N= 24 evaluable (49 dosed) Recruitment 48 (12 extension & 36 expansion) Target: 2 Combination of two peptides MVF HER-2 (597- Drug: Current 626) +MVF HER-2 (266-296) 3 Enrollment: Patient All comers wit
Slide 21: Intellectual Property Portfolio
INTELLECTUAL PROPERTY PORTFOLIO For personal use only • The IP estate comprises at least 6 patent families that comprise pending applications or issued patents: a) compositions of matter and methods of use, of a large range of peptides and vaccines; b) these peptides and vaccines comprise targets PD
Slide 22: Summary of Key Risks
SUMMARY OF KEY RISKS For personal use only • IMU’s clinical trials may prove unsuccessful; • IMU currently has no material revenues. IMU intends to raise additional funds from Australian and international strategic investors mid 2018, which will have a dilutive effect on existing shareholders; • IMU
Slide 23: Acquisition Summary
ACQUISITION SUMMARY • Funding: Capital raise to fund expanded clinical programs through key Strengthens and broadens our clinical data readouts and value inflection points For personal use only B-cell cancer vaccine pipeline • Management team that has delivered on all critical milestones over the la
Slide 24: Leslie Chong, CEO & Managing Director
For personal use only Leslie Chong Chief Executive Officer & Managing Director v leslie.chong@imugene.com +61 458 040 433