Imugene Ltd · ASX:IMU
Imugene — Investor Presentation (July 2023)
38 slides from Imugene's investor presentation, Jul 20, 2023
Slide 1: Developing Cancer Immunotherapies
For personal use only ASX: IMU Developing Our mission is to develop transformative cancer medicines to improve patients’ lives and to establish Cancer value and trust with our stakeholders. Immunotherapies July 2023 Release authorised by the Managing Director and Chief Executive Officer Imugene Limi
Slide 2: Disclaimer
DISCLAIMER 1. The information in this presentation does not constitute personal 4. Neither the Company nor any of its directors, officers, employees, investment advice. The presentation is not intended to be advisers, associated persons or subsidiaries are liable for any direct, For personal use onl
Slide 3: Immunotherapy unleashes the immune system to fight cancer
IMMUNOTHERAPY UNLEASHES THE IMMUNE SYSTEM TO FIGHT CANCER Cellular Therapy Transfer of human cells to find and fight cancer (CAR-T) or For personal use only replace diseased cells Medications that regulate and boost part of the immune Immunomodulators system (ex, immune checkpoint inhibitors) Modifi
Slide 4: Investment highlights
INVESTMENT HIGHLIGHTS MARKET A$674M A$152M CAPITALISATION 19 July 2023 CASH AS OF 31 March 2023 US$449M US$103M For personal use only CF33 B-Cell CHECKvacc Oncolytic Virus onCARlytics Immunotherapies DISEASE AREAS HER-Vaxx 3 Breast (TNBC) PLATFORM Lung (NSCLC) TECHNOLOGIES Gastric VAXINIA onCARlytic
Slide 5: Three unique platforms maximize opportunities in cancer
THREE UNIQUE PLATFORMS MAXIMIZE OPPORTUNITIES IN CANCER Treatments that can be combined with and enhance outcomes of existing standards of care For personal use only CF33 B Cell onCARlytics Oncolytic Immunotherapy Virus onCARlytics CHECKvacc VAXINIA HER-Vaxx PD1-Vaxx PCT patent filed in PCT patent f
Slide 6: Professor Yuman Fong M.D
PROFESSOR YUMAN FONG M.D For personal use only Chairman of the Department of Surgery, City of Hope Cancer Center Clinical specialty: open and robotic surgeries to remove liver cancer Developed many new surgical techniques and instruments for human use Led research efforts to use genetically modified
Slide 7: Academic and industrial collaboration
ACADEMIC AND INDUSTRIAL COLLABORATION Helped Genentech with For personal use only development of human growth hormone Helped virus companies bring Importance of collaboration: viruses to trials • Neurovir, Medigene, Genelux • Innovation and scientific rigor of academic universities Held regulatory r
Slide 8: CF33 Oncolytic Virus
For personal use only CF33 ONCOLYTIC VIRUS
Slide 9: Oncolytic viruses: how a virus kills a cell
ONCOLYTIC VIRUSES HOW A VIRUS KILLS A CELL For personal use only Step 1: Step 2: Step 3: Virus enters Virus duplicates Cell explodes, cell itself releasing thousands of brand new virus particles Virus 9
Slide 10: Oncolytic viruses are great cancer killing agents
ONCOLYTIC VIRUSES ARE GREAT CANCER KILLING AGENTS For personal use only Can infect and kill cancer stem cells LN 2 mm Mol Ther Oncolytics, 3:16013, 2016 Can infect tumour cells invaded into nerves and LN restore function PLoS ONE 4: e4789, 2009 Can travel along lymphatic vessels and kill cancer J Na
Slide 11: Oncolytic virus can transform cold tumours to hot tumours
ONCOLYTIC VIRUS CAN TRANSFORM IMMUNOLOGICALLY COLD TUMOURS TO HOT TUMOURS; COMBINATION WITH CPI’S For personal use only Methods of cancer cell killing • Direct Lysis • Immuno-activation 11 11
Slide 12: T-Vec OPTiM Trial
T-Vec (OncovecGM-CSF) OPTiM Trial Phase III : T-Vec intratumoural versus SQ GM-CSF For personal use only T-Vec was the first FDA approved OV therapy • Herpes simplex virus encoding hGM-CSF • N=430 • Stage IIIB, IIIC, IV melanoma T-Vec GM-CSF Objective Response Rate (ORR) 26% 6% • Complete Response (
Slide 13: Last generation oncolytic viruses
LAST GENERATION ONCOLYTIC VIRUSES DEVELOPMENT PHASE PRODUCT TARGET/VIRUS COMPANY For personal use only & KEY RESULTS Squamous cell carcinoma of the head and Oncorine Sunway Approved in China Too worried about toxicity neck/Ad • Made viruses too Talimogene laherparepvec Melanoma/HSV-1 Amgen Approved
Slide 14: CF33 Oncolytic Virus
For personal use only CF33 Oncolytic Virus • 2014- moved to City of Hope Cancer Center • Robust research and trials infra-structure • GMP Productions Facility • Phase 1-2 Trials Unit • History of Academic-Industrial Partnership
Slide 15: Major advantages of VAXINIA CF33
MAJOR ADVANTAGES OF VAXINIA CF33 Highly potent cancer killing For personal use only Robust Efficacy Converts ‘cold’ tumours to responsive ‘warm’ tumours Direct intra-tumour and systemic anti-tumour activity Large therapeutic window Well-Tolerated Genetically stable Combinability with targeted therap
Slide 16: Generation and evaluation of novel chimeric poxviruses
GENERATION & EVALUATION OF NOVEL CHIMERIC POXVIRUSES VIRUS 1 VIRUS 2 …VIRUS 9 S T R AT E GY Engineer Novel Chimeric Viruses For personal use only High Through-put Screening for Efficacy Against NCI60 Safe in Animals Goal: safe, highly potent virus for killing of any cancer Hope Oncolytic Viruses (HO
Slide 17: Compelling killing of many tumour types at low doses
COMPELLING KILLING OF MANY TUMOUR TYPES AT LOW DOSES For personal use only 17
Slide 18: Safely delivered IT, IP, IV with large therapeutic index
SAFELY DELIVERED IT, IP, IV WITH LARGE THERAPEUTIC INDEX • In many tumour models, animals cured with a single injection of 1000 pfu • NO TOXICITY UNTIL OVER 109 For personal use only • Virus restricted to tumour • 6 log therapeutic index # OF VIRUS MOUSE DOSE DELIVERY TOXICITY MICE CF33-NIS Nude 73
Slide 19: Tumour microenvironment: immunogenic and immunosuppressive components
TUMOUR MICROENVIRONMENT – IMMUNOGENIC AND IMMUNOSUPPRESSIVE COMPONENTS Direct lysis of cancers For personal use only CF33 Effects Enhances expression of check-point targets to enhance Helps antigen activity of CPI presentation cells to establish long-lasting immunity Recruits to tumour sites CD8+, C
Slide 20: CHECKvacc Phase 1 TNBC IST
CHECKvacc PHASE 1 TNBC IST City Of Hope – DR RAND For personal use only COHORT 6 | 3-6 PATIENTS Identify: Optimal Metastatic Triple Negative COHORT 5 | 3-6 PATIENTS Biological Dose (OBD) Breast Cancer OBD Expansion Based on: 12 Patients -2 prior lines of treatment COHORT 4 | 3-6 PATIENTS 1x107 • Saf
Slide 21: MAST: VAXINIA Phase 1 advanced solid tumours study
MAST: VAXINIA PHASE 1 METASTATIC ADVANCED SOLID TUMOURS STUDY Dose Administration For personal use only (Parallel Groups) VAXINIA VAXINIA + Pembrolizumab Monotherapy Dose Escalation Combination Dose Escalation* Cohort Expansion n=52-100 patients IT IT IV IT IV IT Administration COHORT COHORT COHORT
Slide 22: onCAR19 for solid tumours
onCAR19 FOR SOLID TUMOURS For personal use only
Slide 23: What is CAR T therapy? A living drug
WHAT IS CAR T THERAPY? – A LIVING DRUG CAR T cell therapy is a type of immunotherapy that uses a patient’s own genetically modified T Cells to find and kill cancer ( think of a 21st Century blood transfusion) For personal use only 1 2 3 T Cells are taken from patients The re-programmed CD 19 T When
Slide 24: CAR T therapy successes in hematological malignancies
CAR T THERAPY SUCCESSES IN HEMATOLOGICAL MALIGNANCIES OVERALL FIRST FDA APPROVED BRAND COMPANY TARGET RESPONSE For personal use only APPROVAL CANCERS RATE 2017 CD19 B-ALL, DLBCL 53-86% 2017 CD19 DLBCL, R/R FL 72-91% 2020 CD19 R/R MCL 65*-87% 2021 CD19 DLBCL 73-87% 2021 BCMA R/R MM 72% 2022 BCMA R/R
Slide 25: Broad range of FDA approved CD19 targeted therapies
BROAD RANGE OF FDA APPROVED CD19 TARGETED THERAPIES FIRST FDA MODALITY BRAND COMPANY INDICATIONS For personal use only APPROVAL 2020 DLBCL CD19 Monoclonal Antibodies (MAb) 2020 NMOSD CD19-CD3 Bispecific MAbs 2014 ALL CD19 Antibody-drug conjugate 2021 B cell lymphoma (ADC) https://www.hcp.novartis.co
Slide 26: Obstacles for targeting solid tumours with CAR-T
OBSTACLES FOR TARGETING SOLID TUMOURS WITH CAR-T For personal use only Many cancer Ag expressed in normal tissues and result in off-tumour, on-target toxicity • Her-2 Heart • CEA Colon • PSMA Intestines, kidney Many specific cancer proteins are intracellular (e.g. AFP) Nat Rev Clin Oncol 20:49, 2023
Slide 27: Obstacles for cancer immunotherapy: tumour heterogeneity
OBSTACLES FOR CANCER IMMUNOTHERAPY – TUMOUR HETEROGENEITY Heterogeneity in tumour Antigen Expression For personal use only Heterogeneity in tumour Microenvironment Inter-tumour Heterogeneity Intra-tumour Heterogeneity 27
Slide 28: Challenges limiting use of CAR T therapies for solid tumours
CHALLENGES LIMITING USE OF CAR T THERAPIES FOR SOLID TUMOURS For personal use only TUMOUR ANTIGEN LOSS OF POOR HIGHLY HETEROGENEITY ACTIVITY PENETRATION IMMUNOSUPPRESSIVE No common, abundant CAR T therapies loose Inefficient trafficking Tumour surface protein to function after chronic and infiltrati
Slide 29: onCARlytics make solid tumours seen by CD19 targeting therapies
onCARlytics MAKE SOLID TUMOURS “SEEN” BY CD19 TARGETING THERAPIES • CD19 is commonly expressed in blood cancers and is used with targeted therapies like CAR Ts to identify and kill tumour cells in a homogeneous manner For personal use only • Solid tumour cells don’t have a common, abundant protein o
Slide 30: onCARlytics delivers CAR targets to targetless solid tumours
onCARlytics DELIVERS CAR TARGETS TO “TARGETLESS” SOLID TUMOURS Combination of onCARlytics (CF33-CD19) For personal use only and CD19-CAR T cells promotes tumour regression in xenograft model of TNBC i.t.10M i.t. 5M Mock or pfu OV19t CD19-CAR T cells s.c. MDA-MB-468 onCARlytics (CF33-CD19) infects a
Slide 31: onCARlytics combination with CD19 targeting therapies
onCARlytics COMBINATION WITH CD19 TARGETING THERAPIES Collaboration with Celularity, Eureka and Arovella for combination with onCARlytics For personal use only AUG 2021 NOV 2021 SEP 2022 Strategic Strategic Strategic Partnership Partnership Partnership with Celularity with Eureka with Arovella Allog
Slide 32: onCAR19 Phase 1 OASIS study
onCAR19 (CF33-CD19) PHASE 1 OASIS STUDY (Metastatic Advanced Solid Tumours) onCAR19 Monotherapy onCAR19 + Blinatumomab Cohort Expansion Safety Run-In Combination Dose Escalation* For personal use only Dose Administration (Parallel Groups) IT IV IT IV n=~52 IT IT Administration Metastatic and COHORT
Slide 33: CF33 future directions
CF33- FUTURE DIRECTIONS For personal use only Universal platform for tumour targeting Potential for becoming enabler for universal Car-T therapy Likely to expand market for CPI, Car-T, T-cell engagers, ADCs Transgenes for enhancing T-cell survival and expansion New targets for synergistic actions wi
Slide 34: Why Imugene?
WHY IMUGENE? For personal use only DIVERSE ASSET EXPERIENCED ONGOING CLINICAL ROBUST CASH PORTFOLIO WITH MANAGEMENT TRIALS IN DIVERSE RUNWAY WITH MULTIPLE SHOTS TEAM SOLID TUMOURS FUNDING ON GOAL ACROSS WITH MULTIPLE THROUGH KEY THREE NOVEL VALUE INFLECTION MILESTONES PLATFORMS POINTS 34
Slide 35: Multiple value realisation pathways
MULTIPLE VALUE REALISATION PATHWAYS For personal use only They often manage more money than hedge funds or LICENSE COMPANY mutual funds PARTNER WITH BIG TECHNOLOGIES AQUISITION PHARMA SEPARATELY 35
Slide 36: Value inflection points expected in the next months
VALUE INFLECTION POINTS EXPECTED IN THE NEXT 12 MONTHS CHECKvacc DOMINICA: CHECKvacc FDA IND COH IST: Optimal For personal use only Biological Dose HER – Vaxx neoHERIZON: FPI HER – Vaxx nextHERIZON: Interim Data VAXINIA Readout MAST: VAXINIA Indication Expansion MAST: VAXINIA Combination MAST: Optim
Slide 37: Financial summary
FINANCIAL SUMMARY PUBLIC MARKET OVERVIEW (July 19, 2023) SHARE PRICE PERFORMANCE Share Price A$0.105 For personal use only 52 week range A$0.082 - A$0.315 Market Capitalisation1 A$674M Cash equivalents (31 March ‘23) A$152M Enterprise Value A$522M TOP 5 SHAREHOLDERS (May 24, 2023) Paul Hopper 4.94%
Slide 38: Contact
Contact For personal use only shareholderenquiries@imugene.com www.imugene.com ASX: IMU