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IMUGENE LIMITED — AGM Information 2021
Nov 18, 2021
65124_rns_2021-11-18_7a09d2c4-6099-4787-a2e0-8028cf448d09.pdf
AGM Information
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A S X : I M U
IMUGENE AGM 2021
Experienced Management Team with Significant Clinical Development Expertise
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Imugene has a team with oncology clinical development experience
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Dr Rita Laeufle
CALIFORNIA, USA
Chief Medical Officer
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27+ years of oncology experience in academia and industry
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Clinical development experience with bevacizumab, trastuzumab, abituzumab, CPIs and oncolytic viruses from Phase I – to post marketing Phase IV
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Former CMO at Oncolytics Biotech, Ex Genentech, Ex Hoffmann-La Roche, and Ex Novartis
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Dr Monil Shah
NEW JERSEY, USA Chief Business Officer
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20+ years of oncology development experience in the pharmaceutical industry
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Former CDO at WindMIL, COO at Brooklyn
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ImmunoTherapeutics, and Head of Medical Affairs of ImmunoOncology at BMS
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Held senior roles at Novartis, Amgen, Fibrogen, and Celgene
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Dr Nick Ede
MELBOURNE, AUS Chief Technology Officer
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25+ years peptide vaccine and drug development
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Former CEO Adistem and CEO of Mimotopes , VP Chemistry Chiron (now Novartis), Research Fellow CRC Vaccine Technology
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Dr Anthony Good
SYDNEY, AUS
Senior VP of Clinical Research
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20+ years experience in global clinical development
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Integral to the development of significant new medicines including Viagra®, Lipitor®, and Somavert®
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Ex Pfizer Global Research and Development, Ex Covance Clinical Services
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Amanda Seiz
Bonnie Nixon
ILLINOIS, USA
SYDNEY, AUS Senior Project Manager
Senior Director of Clinical Operations
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10+ years of oncology clinical operations experience across Phase I – IV clinical trials
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20+ years experience in global drug development
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16+ years of clinical operations leadership experience in oncology at CROs, pharmaceutical and biotechnology companies
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Ex North America Study Manager at Genentech, Ex Roche Clinical Operations Australia
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Development experience with small molecules, checkpoint inhibitors, gene/cellular therapies and oncolytic viruses
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Ex Head of Clinical Operations WindMIL Therapeutics, Ex Astellas 2 Pharma, Ex MedImmune
Three Novel Technology Platforms
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onCARlytics
CF33 Oncolytic Virus B Cell Immunotherapy
CHECKvacc
VAXINIA
CF33-CD19 CAR T Combination Therapy “Armed” PD-L1 HER-Vaxx PD1-Vaxx
Parental Virus
Virus
TIGIT-Vaxx, PDL1-Vaxx, LAG3-Vaxx,
TIM3-Vaxx, VEGF-Vaxx, CTLA4-Vaxx etc
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3
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HER-Vaxx
2021 YEAR IN REVIEW
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HERIZON: Phase 2 Interim Results with positive OS
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HERIZON: Enrollment Completed
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Presentations at AACR, ASCO and ESMO World GI
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HERIZON: PFS endpoint reached
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HER-Vaxx patent granted in Japan
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3 New Phase 2 Gastric Studies: neoHERIZON, nextHERIZON and neuHERIZON
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neoHERIZON: Neoadjuvant study in combination with Avelumab with clinical drug supply partnership with Merck KGaA & Pfizer
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4
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2021 YEAR IN REVIEW
PD1-Vaxx
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- PD1-Vaxx FDA IND granted in the USA
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IMPRINTER (Phase 1 Study): All 6 sites open in the USA and Australia
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Presentation at ESMO
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IMPRINTER (Phase 1 Study): Currently at the highest dose cohort
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Current Status
1st Patient Dosed 1st Patient Dosed Cohort 3 Cleared,
Cohort 1 Cleared Cohort 2 Cleared 1st Patient Dosed
Cohort 1 Cohort 2 RP2D & Expansion
Jan 2021 April 2021 Cohort 3
30 Nov 2020 Feb 2021 Opened
Ohio State University
(open)
Hackensack University
(open)
Macquarie University (open)
Chris O'Brien Lifehouse (open)
Cabrini Malvern (open)
Mayo Clinic
(open)
M I L E S T O N E S
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2021 YEAR IN REVIEW
CHECKvacc
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CHECKvacc FDA IST IND granted in the USA
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• Presentation at AACR
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- CHECKvacc First Patient Dosed at COH
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COHORT | 3-6 PATIENTS
Identify:
COHORT | 3-6 PATIENTS Recommended Phase 2
Dose (RP2D)
RP2D Expansion
Metastatic Triple Negative COHORT | 3-6 PATIENTS
Based on:
Breast Cancer
12 Patients
COHORT | 3-6 PATIENTS • Safety
• Immunogenicity
COHORT | 3-6 PATIENTS • Tumour Response
Disease of need Potential target for Treatment responses to Potential for registration
Indication TNBC
immunotherapy Atezolizumab (JAMA in well-designed,
• 8-13 month survival Oncology, 5:74, 2019) randomised P2 study
for metastatic disease • Expresses PD1, FDA IND CHECKvacc: CF33-hNIS-aPDL1
with few treatments PD-L1 • 1st line: 24%;
2nd line: 6% N Part 1=18-24 ; Part 2=12
• Approved by FDA
8 March 2019 Location Single Center: COH
6
Admin Route Intratumoral (IT)
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2021 YEAR IN REVIEW
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onCARlytics
- Licensed a CD19 oncolytic virus invented by Professor Yuman Fong and Dr Saul Priceman from City of Hope to turn CAR-T therapy against solid tumours
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2
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Exclusive strategic partnership to combine onCARlytics with Celularity’s allogeneic CAR-T, CyCART-19 immunotherapy for the treatment of solid tumors
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Strategic Collaboration to combine onCARlytics with Eureka Therapeutics ARTEMIS[®] T-Cell Therapy to accelerate therapy in solid tumours
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2021 Imugene Summary
S e p t e m b e r 2 0 2 1
S&P September
F e b r u a r y J u n e 2 0 2 1 J u l y 2 0 2 1 Quarterly Re-balance N o v e m b e r
2 0 2 1 2 0 2 1
CHECKvacc $95m Toal Imugene enters
PD1-Vaxx dose receives FDA IND Capital Raise ASX300 Strategic Partnership
escalates to &SPP with Eureka
cohort 2
A u g u s t
J u n e 2 0 2 1
M a y 2 0 2 1
2 0 2 1 O c t o b e r
Appointment of Dr
Licensed onCARlytics Monil Shah as the Strategic 2 0 2 1 N o v e m b e r 2 0 2 1
from City of Hope
Chief Business Partnership with CHECKvacc First HER-Vaxx Clinical Trial
invented by Dr Y Fong,
Dr S Priceman & Officer Celularity Patient Dosed Supply Partnership with
Merck KGaA Pfizer
Dr A Park
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8
Milestones
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| estones | ||
|---|---|---|
| Technology | Milestone | |
| onCARlytics | 1st Patient Dosed | |
| onCARlytics | FDA IND Clearance | |
| PD1-Vaxx | Combination RP2D | Next 12-24 months |
| onCARlytics | GLP Toxicology Study | |
| VAXINIA | 1st Patient Dosed | |
| onCARlytics | FDA Pre-IND Meeting | |
| onCARlytics | GMP manufacturing for pre-clinical toxicology & Phase 1 study | |
| VAXINIA | FDA IND Clearance | |
| HER-Vaxx | Neo and Next HERIZON studies | |
| PD1-Vaxx | Maximum Feasible Dose Identified | |
| HER-Vaxx | OS Primary Endpoint | |
| HER-Vaxx | Clinical Trial Supply Partnership with Merck KGaA and Pfizer | |
| onCARlytics | Strategic Partnership with Eureka on autologous CD19 CART | |
| CHECKvacc | TNBC IST 1st Patient Dosed | |
| HER-Vaxx | PFS analysis data | |
| onCARlytics | Strategic partnership with Celularity on allogenic CD19 CART | |
| CHECKvacc | FDA IND Clearance |
9
Financial Summary
| Public Market Overview(17/11/21) | |
|---|---|
| Share Price | A$0.54 |
| 52 week range | 0.089 - 0.625 |
| Market Capitalisation1 | A$3.063B |
| Cash equivalents (30 Sept 21) | A$112.2M |
| Enterprise Value | A$2.946B |
| Top 5 Shareholders(as at November 2021) | |
| Paul Hopper | 6.96% |
| HSBC Custody Nominees (Australia) | 5.98% |
| Richard Mann and Assoc. | 5.35% |
| JP Morgan Nominees Australia Pty Limited |
4.57% |
| Citicorp Nominees Pty Limited | 3.67% |
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Share Price Performance (last 12 months)
0.70
0.60
0.50
0.40
0.30
0.20
0.10
0
Nov-20 Dec-20 Jan-21 Feb-21 Mar-21 Apr-21 May-21 Jun-21 Jul-21 Aug-21 Sep-21 Oct-21 Nov-21
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Note:
- Market capitalisation calculations based on ordinary shares (5.673 bn) only and excludes the dilutive impact of options outstanding (0.558 bn)
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A S X : I M U
IMUGENE LIMITED www.imugene.com [email protected]