Imugene Ltd · ASX:IMU
Imugene — Investor Presentation (November 2022)
31 slides from Imugene's investor presentation, Nov 15, 2022
Slide 1: Developing Cancer Immunotherapies
For personal use only ASX: IMU Developing Cancer Immunotherapies November 2 0 2 2 Release authorised by the Managing Director and Chief Executive Officer Imugene Limited, Level 3, 62 Lygon Street, Carlton, VIC, 3053, Australia
Slide 2: Disclaimer
DISCLAIMER For personal use only 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
Slide 3: Imugene's Management Team
IMUGENE’S MANAGEMENT TEAM Experienced management team with significant clinical development expertise For personal use only Leslie Chong Dr Nick Ede Dr Anthony Good Ursula McCurry Bonnie Nixon Amanda Seiz Chief Executive Chief Technology Snr VP of Snr VP of Clinical Snr Project Snr Director of Offic
Slide 4: Introduction to Imugene
INTRODUCTION TO IMUGENE Imugene is a biotech company headquartered in Australia and publicly traded on the Australian Securities Exchange (ASX:IMU) For personal use only Licensed extensive Licensed onCARlytics HER-Vaxx Clinical Leslie Chong B cell portfolio and from City of Hope Trial Supply from pl
Slide 5: Three Technology Platforms
THREE TECHNOLOGY PLATFORMS For personal use only PLATFORM CF33-CD19 CAR T Combination Therapy CHECKvacc VAXINIA HER-Vaxx PD1-Vaxx IP IP TO 2038 IP TO 2037 IP TO 2037 IP TO 2036 IP TO 2037 TBC COH TNBC IST MAST CLINICAL TRIALS HERIZON IMPRINTER Phase 1 Phase 1 Phase 1 Phase 1b/2 Phase 1 Solid Tumours
Slide 6: Investment Highlights
INVESTMENT HIGHLIGHTS For personal use only MARKET CAPITALISATION 11th Nov 2022 A$1.23B CASH AS OF 30th Sep 2022 A$163.8M CF33 B-Cell CHECKvacc Oncolytic Virus onCARlytics Immunotherapies HER-Vaxx 3 DISEASE AREAS Breast (TNBC) PLATFORM Lung (NSCLC) TECHNOLOGIES Gastric VAXINIA CF33-CD19 Gastroesopha
Slide 7: Professor Yuman Fong
PROFESSOR YUMAN FONG The Sangiacomo Family Chair in Surgical Oncology and chair of The City of Hope Dept of Surgery is an internationally recognized expert in liver and pancreatic cancer. He has developed many new surgical For personal use only techniques and instruments. He helped usher in robotic
Slide 8: CF33 Oncolytic Virus
For personal use only CF33 Oncolytic Virus
Slide 9: Oncolytic Viruses: How a Virus Kills a Cell
ONCOLYTIC VIRUSES For personal use only HOW A VIRUS KILLS A CELL Step 1: Step 2: Step 3: Virus enters Virus duplicates Cell explodes, cell itself releasing thousands of brand new virus particles Goal is to engineer viruses that; Methods of cancer cell killing • Tvec approved 2015 for • Infect and ki
Slide 10: Last Generation Oncolytic Viruses
LAST GENERATION ONCOLYTIC VIRUSES For personal use only DEVELOPMENT PHASE PRODUCT TARGET/VIRUS COMPANY & KEY RESULTS Squamous cell carcinoma of the head and Oncorine Sunway Approved in China Too worried about toxicity neck/Ad Talimogene • Made virusesMelanoma/HSV-1 too Amgen Approved in USA laherpar
Slide 11: Why a Vaccinia Virus?
WHY A VACCINIA VIRUS? • Large DNA virus that is genetically very stable For personal use only • Most effective biologic therapy in history of man: vaccine that eradicated smallpox • Highly cytolytic for a broad range of tumor cell types • Amenable to large scale production • Does not integrate into
Slide 12: Generation & Evaluation of Novel Chimeric Poxviruses
GENERATION & EVALUATION OF NOVEL CHIMERIC POXVIRUSES S T R AT E GY For personal use only VIRUS 1 VIRUS 2 …VIRUS 9 Engineer Novel Chimeric Viruses High Through-put Screening for Efficacy Against NCI60 Safe in Animals Arming with Additional Payloads • 200 new backbones (new species) • High through-put
Slide 13: Compelling Killing of Many Tumour Types at Low Doses
COMPELLING KILLING OF MANY TUMOUR TYPES AT LOW DOSES For personal use only 13
Slide 14: VAXINIA: CF33-hNIS Parental Virus
grafts were impla tumor. When tu .moleculartherapy.org 150 mm3, mice VAXINIA: CF33-hNIS “Parental Virus” PBS, CF33-FLuc Comparisons of ment and contr PET/CT I-124 imaging of CF33-hNIS 200 mCi of I-124 For personal use only Note I-124 uptak injection of only symporter; PFU, Our present st hNIS and I-
Slide 15: Safely Delivered IT, IP, IV with Large Therapeutic Index
SAFELY DELIVERED IT, IP, IV WITH LARGE THERAPEUTIC INDEX For personal use only # OF VIRUS MOUSE DOSE DELIVERY TOXICITY MICE CF33-NIS Nude 73 1e3-1e5 IT No findings CF33-miR Nude 41 1e3-1e5 IT No findings CF33-Luc Nude 48 1e3-2e5 IT, IV & IP No findings NSG 8 1e6 IT CF33-GFP Nude 18 1e3-2e7 IT No fin
Slide 16: Major Advantages of CF33
MAJOR ADVANTAGES OF CF33 For personal use only • Preclinical data has • Tumor type-agnostic: • Novel combination use of KEY DIFFERENTIATION demonstrated that ’universal’ approach to FDA-approved cellular 1. CF33 OV Platform: CF33 is more targeting solid tumors immunotherapy (CD19- • high potency in
Slide 17: CHECKvacc Phase 1 TNBC Study
CHECKvacc PHASE 1 TNBC STUDY CF33+hNIS+aPD-L1 (“Armed” Virus) For personal use only ACCEPTED TO SABC 2022 COHORT 8 | 3-6 PATIENTS Identify: Metastatic Triple Negative Breast … Recommended Phase 2 Dose (RP2D) RP2D Expansion Cancer Based on: COHORT 2 | 3-6 PATIENTS 12 Patients • Safety - 2 prior lines
Slide 18: VAXINIA Phase 1 MAST Study
VAXINIA Phase 1 MAST Study (Metastatic Advanced Solid Tumours) For personal use only First Patient Enrolled May 2022, IT Cohort 1 Cleared Sept 2022 Dose Administration VAXINIA Monotherapy VAXINIA + Pembrolizumab Cohort Expansion (Parallel Groups) Dose Escalation Combination Dose Escalation* n=52-100
Slide 19: Dr Saul Priceman
DR SAUL PRICEMAN Saul Priceman, Ph.D., is an assistant professor and associate director of Translational Sciences & Technologies in the T Cell Therapeutics Research Laboratories at City of Hope, as well as a trained tumor immunologist with expertise in T cell For personal use only biology and cancer
Slide 20: CF33-CD19
For personal use only CF33-CD19
Slide 21: The Cell Therapy Solid Tumour Challenge & Imugene's Solution
The Cell Therapy Solid Tumour Challenge & Imugene’s Solution NEW CONCEPT For personal use only Utilise OV’s as a delivery vector to Cell therapy, including Chimeric Antigen Receptor (CAR) T cell therapy, deliver CD19 antigen to solid tumour has had limited activity in solid tumours, largely due to a
Slide 22: Mechanism of Action: How Does It Work?
MECHANISM OF ACTION: How does it work? For personal use only onCARlytics makes solid tumours “seen” by CD19 targeting therapies 1. OnCARlytics infects tumour cells 2. Virus replication and production of CF33-CD19 on the cell surface enabling CD19 cell targeting 3. Tumour cell lysis leads to viral pa
Slide 23: onCARlytics Delivers CAR Targets to Targetless Solid Tumours
MOI 1 <1% MOI 0 6.8% CD19t 11.5% 22.2% bioRxiv preprint doi: https://doi.org/10.1101/843052 ; this version posted November 37.8% 63.8%holder for98.0% 16, 2019. The copyright this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without per
Slide 24: onCARlytics Combination with CD19 Targeting Therapies
onCARLYTICS COMBINATION WITH CD19 TARGETING THERAPIES For personal use only AUG 2021 NOV 2021 SEP 2022 Strategic Strategic Strategic Partnership Partnership Partnership with Celularity with Eureka with Arovella 3 x POSTERS PRESENTED AT SITC 2022 FDA APPROVED CD19 TARGETING THERAPIES Approved and in-
Slide 25: CF33-CD19T with Off-the-Shelf Allogeneic CYCART-19 T-Cells
CF33-CD19T ONCOLYTIC VIRUS (onCARlytics) IN COMBINATION WITH OFF-THE-SHELF ALLOGENEIC CYCART-19 T-CELLS TARGETING DE NOVO CD19T EXPRESSING TUMORS Anthony K. Park1, Isabel Monroy1, Colin Cook2, Shuyang He3, Kathy Karasiewicz3, Monil Shah4, Leslie M.O. Chong4, Nimali P. Withana4, Robert Hariri3, Yuman
Slide 26: CF33-CD19T Targets Hepatocellular Carcinoma with ARTEMIS T-Cells
CF33-CD19T ONCOLYTIC VIRUS (onCARlytics) TARGETS HEPATOCELLULAR CARCINOMA (HCC) AND IN COMBINATION WITH CD19 ARTEMIS® T-CELLS RESULTS IN SIGNIFICANT TUMOR KILLING Anthony K. Park1, Isabel Monroy1, Colin Cook2, Guangyan Xiong3, Vivien Chan3, Cheng Liu3, Monil Shah4, Leslie M.O. Chong4, Nimali P. With
Slide 27: onCARlytics to Redirect CD19 Bispecific T-Cell Engagers
COMBINATION IMMUNOTHERAPY USING A NOVEL CHIMERIC ONCOLYTIC VIRUS (ONCARLYTICS) TO REDIRECT CD19 BISPECIFIC T-CELL ENGAGERS TO TARGET SOLID TUMORS Anthony K. Park1, Isabel Monroy1, Colin Cook2, Monil Shah3, Leslie M.O. Chong3, Nimali P. Withana3, Stephen J. Forman1, Yuman Fong2, and Saul J. Priceman1
Slide 28: Milestones
MILESTONES TECHNOLOGY MILESTONE onCARlytics Phase 1 - 1st Patient Dosed For personal use only HER-Vaxx nextHERIZON Arm 2 Cleared CHECKvacc Sponsored Study FDA IND VAXINIA Combination – 1st Patient Dosed onCARlytics FDA IND PD1-Vaxx Combination - 1st Patient Dosed NEXT 1 -12 MONTHS CHECKvacc Cohort 3
Slide 29: Financial Summary
FINANCIAL SUMMARY PUBLIC MARKET OVERVIEW (11 Nov 22) SHARE PRICE PERFORMANCE For personal use only Share Price A$0.195 52 week range $0.13 - $0.625 Market Capitalisation1 A$1.23B Cash equivalents (30 Sep 22) A$163.8M Enterprise Value A$1.07B TOP 5 SHAREHOLDERS (AS AT 11 NOVEMBER 2022) JP Morgan Nomi
Slide 30: Investment Highlights
INVESTMENT HIGHLIGHTS For personal use only MARKET CAPITALISATION 11th Nov 2022 A$1.23B CASH AS OF 30th Sep 2022 A$163.8M CF33 B-Cell CHECKvacc Oncolytic Virus onCARlytics Immunotherapies HER-Vaxx 3 DISEASE AREAS Breast (TNBC) PLATFORM Lung (NSCLC) TECHNOLOGIES Gastric VAXINIA CF33-CD19 Gastroesopha
Slide 31: Contact
For personal use only Contact info@imugene.com www.imugene.com ASX: IMU