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IMUGENE LIMITED — AGM Information 2022
Nov 16, 2022
65124_rns_2022-11-16_9b49adfa-ded9-447f-9f80-9b7a1a6a6206.pdf
AGM Information
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A S X : I M U
Developing Cancer Immunotherapies
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AGM November 2022
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DISCLAIMER
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The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Imugene Limited (Company). In preparing this presentation, the Company did not take into account the investment objectives, financial situation and particular needs of any particular investor.
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Further advice should be obtained from a professional investment adviser before taking any action on any information dealt with in the presentation. Those acting upon any information without advice do so entirely at their own risk.
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Whilst this presentation is based on information from sources which are considered reliable, no representation or warranty, express or implied, is made or given by or on behalf of the Company, any of its directors, or any other person about the accuracy, completeness or fairness of the information or opinions contained in this presentation. No responsibility or liability is accepted by any of them for that information or those opinions or for any errors, omissions, misstatements (negligent or otherwise) or for any communication written or otherwise, contained or referred to in this presentation.
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associated persons or subsidiaries are liable for any direct, indirect or consequential loss or damage suffered by any person as a result of relying upon any statement in this presentation or any document supplied with this presentation, or by any future communications in connection with those documents and all of those losses and damages are expressly disclaimed.
- Any opinions expressed reflect the Company’s position at the date of this presentation and are subject to change
International offer restrictions - This document does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States or any other jurisdiction in which it would be unlawful. In particular, the New Shares have not been, and will not be, registered under the US Securities Act of 1933 and may not be offered or sold in the United States except in transactions exempt from, or not subject to, the registration requirements of the US Securities Act and applicable US state securities laws. The distribution of this presentation in jurisdictions outside Australia may be restricted by law and any such restrictions should be observed.
- Neither the Company nor any of its directors, officers, employees, advisers,
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2022 IMUGENE SUMMARY
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January 2023 HER-Vaxx HERIZON December and nextHERIZON at September 2022 2021 ASCO GI August 2022 Raises A$80m in CHECKvacc Phase 1 May 2022 institutional presenting at SABCS CHECKvacc Phase 1 First patient dosed placement January 2022 trial reaches in VAXINIA MAST December PD1-Vaxx Phase 1 trial cohort 3 2021 IMPRINTER Phase 1a trial completed September 2022 HER-Vaxx Phase 2 November 2022 HERIZON study oral Strategic partnership June presentation at ESMO with Arovella for onCARlytics 2022 Asia January 2022 onCARlytic showcased in three December 2021 Clinical trial supply Positive overall posters at SITC annual agreement with Roche survival results from meeting FDA IND approval for HER-Vaxx HERIZON for the IMPRINTER VAXINIA MAST & HERPhase 2 trial Study Vaxx nextHERIZON studies 3
INVESTMENT HIGHLIGHTS
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MARKET CAPITALISATION 16 [th] Nov 2022 A$1.29B CASH AS OF 30 [th] Sep 2022 A$163.8M
CF33 B-Cell Immunotherapies
CHECKvacc OncolyticVirus onCARlytics
HER-Vaxx
Breast(TNBC)
PLATFORM TECHNOLOGIES Lung(NSCLC)
Gastric
VAXINIA 3
CF33-CD19
Gastroesophageal
Colorectal(CRC)
Celularity Eureka
Melanoma
UNIQUE PD1-Vaxx Head and Neck
5 ASSETS Hepatocellular
Pancreatic
SCIENTIFIC
Multiple potential platform targets CF33-CD20TIGIT-Vaxx LAG3-VaxxPDL1-Vaxx CTLA4-VaxxTIM3-Vaxx 3 COLLABORATIONS Arovella Glioblastoma (GBM)
CLINICAL STUDIES
HERIZON: Ph1b/2 First line Gastric Cancer MAST: Ph1 Solid Tumours (FDA IND) SUPPLY AGREEMENTS
IMPRINTER: Ph1 NSCLC (FDA IND) DOMINICA: Ph1 TNBC (FDA IND) 2
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CHECKvacc COH IST: Ph1 TNBC (FDA IND) onCARlytics: Ph1 Solid Tumours (FDA IND)
neoHERIZON: Ph 2 Neoadjuvant Gastric Cancer neuHERIZON: Ph2 Biomarker Study Merck
Roche
nextHERIZON: Ph2 Metastatic Gastric Cancer (FDA IND) PD1-Vaxx IST: Ph1 CRC KGaA/Pfizer
DISEASE AREAS
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IMUGENE’S MANAGEMENT TEAM
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Experienced management team with significant clinical development expertise
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Leslie Chong
Chief Executive
Officer & Managing Director
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Dr Nick Ede
Chief Technology
Officer
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Dr Anthony Good
Snr VP of
Clinical Research
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Ursula McCurry
Snr VP of Clinical
Operations
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Bonnie Nixon
Snr Project
Manager
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Snr Director of Clinical Operations
Chief Medical Officer
Chief Business Officer
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Mike Tonroe
Chief Financial Officer
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Dr Paul Wright
VP of CMC
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Dr Sharon Yavrom
Executive Director,
Clinical Science
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HER-Vaxx 2022 YEAR IN REVIEW
HERIZON:
- Phase 2 Final OS Readout with positive overall survival
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Poster at ESMO World GI
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Oral presentation at ESMO ASIA
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Oral presentation at ASCO GI 2023
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nextHERIZON:
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FDA IND approval
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First Patient Dosed
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Abstract accepted to ASCO GI
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neoHERIZON
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Clinical supply agreement with Merck KGaA and Pfizer
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| E N D P O I N T | OVERALL SURVIVAL Final OS Readout |
| Treatment | HER-Vaxx + Chemo Chemo Only |
| Sample Size | 19 17 |
| Events | 15 17 |
| Median OS (2-sided 80% CI) |
13.9 months (7.5, 14.3) 8.3 months (6.0, 9.6) |
| Median Duration of Response |
30 weeks 19 weeks |
| HR | 0.585 |
| 2-sided 80%CI | (0.368, 0.930) |
| Log-rank Test (1-sided p-value)* |
0.066 + |
HER-Vaxx Immunotherapy Patents granted in:
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Europe
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China
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South Korea
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Japan
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PD1-Vaxx 2022 YEAR IN REVIEW
IMPRINTER:
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Completed Phase 1a monotherapy dose escalation
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Clinical trial supply agreement with Roche to evaluate PD1-Vaxx in combination with Tecentriq®
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Abstract was published for ASCO 2022
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Poster presented at 2022 World Conference on Lung Cancer
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CHECKvacc 2022 YEAR IN REVIEW
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Phase 1, single centre, dose-escalation study in triple negative breast cancer at COH – FDA approval, first patient dosed, cohort 3 open
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Publication of abstract at American Society of Clinical Oncology Annual (ASCO) Annual Meeting
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Abstract accepted to San Antonio Breast Cancer Symposium (SABC)
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VAXINIA 2022 YEAR IN REVIEW
Phase 1 MAST Study:
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FDA IND Approval
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First Patient Dosed IT Cohort 1
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OGTR License Granted
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First Patient Dosed IV Cohort 1
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First Patient Dosed IT Cohort 2
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Partnership with ABL for manufacture of VAXINIA
CF33 Patent Granted:
- Japan
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VAXINIA Monotherapy Dose Escalation
Dose Administration (Parallel Groups)
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n=52-100
IT
IV
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IT IV
COHORT COHORT
3-6 PATIENTS 3-6 PATIENTS
COHORT COHORT
3-6 PATIENTS 3-6 PATIENTS
COHORT COHORT
3-6 PATIENTS 3-6 PATIENTS
COHORT COHORT
3-6 PATIENTS 3-6 PATIENTS
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IT Administration Metastatic and Advanced Solid Tumours
IV Administration Metastatic and Advanced Solid Tumors
Site Location: USA, AUS
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onCARlytics 2022 YEAR IN REVIEW
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Showcased three abstracts at SITC :
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Combination immunotherapy using a novel chimeric oncolytic virus to redirect CD19 bispecific T cell engagers to target solid tumors
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CF33-CD19T oncolytic virus (onCARlytics) in combination with off-the-shelf allogenic CYCART-19 T-cells targeting de novo CD19T expressing tumors
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CF33-CD19t oncolytic virus (onCARlytics) targets hepatocellular carcinoma (HCC) and in combination with CD19-Redirected ARTEMIS[®] T cells results in significant tumor killing
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New preclinical trial to be conducted with Arovella Therapeutics CAR19-iNKT cell therapy
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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 techniques and instruments. He helped usher in robotic surgery for liver cancer. He has also led research efforts to use genetically modified viruses to destroy cancer cells.
Dr. Fong joined City of Hope in 2014 after more than three decades at Memorial Sloan-Kettering Cancer Center in New York City.
Dr. Fong has written and edited >1000 scholarly articles as well as 22 textbooks. He is the founding Editor-in-Chief of Molecular Therapy Oncolytics (Cell Press).
He is a fellow of the American Institute of Medical and Biologic Engineering, and the National Academy of Medicine.
Dr. Fong has had leadership roles in regulatory aspects of gene therapy, including serving as Chair or the Recombinant DNA Advisory Committee of the National Institutes of Health of the United States.
City of Hope, in Los Angeles, is a leading research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, it is designated as a comprehensive cancer center, the highest recognition bestowed by the National Cancer Institute. City of Hope is also a founding member of the National Comprehensive Cancer Network, with research and treatment protocols that advance care throughout the US.
City of Hope has been ranked as one of the nation’s “Best Hospitals” in cancer by U.S. News & World Report for over 10 years.
City of Hope has GMP facilities that produces clinical trials materials for many academic centers and is the alpha clinic trials site for CIRM
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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 biology and cancer immunotherapy. He is developing chimeric antigen receptor (CAR)-based T cell immunotherapy primarily for solid cancers, with a strong focus on metastatic disease in breast, prostate and pancreatic cancer.
Dr. Priceman received his B.S. in microbiology at University of California Santa Barbara, and his Ph.D. in molecular and medical pharmacology at University of California Los Angeles.
Dr. Priceman is a principal investigator on a Prostate Cancer Foundation Young Investigator award, a co-principal investigator on a Prostate Cancer Foundation Challenge Award and a principal investigator on a National Comprehensive Cancer Network Young Investigator award, leading the development of HER2-specific CAR T therapy for metastatic breast cancers and working with his team optimizing new CAR T cell therapies for various other solid cancers.
Dr. Priceman is deeply committed to rapidly advancing potentially paradigm-shifting immunotherapy on behalf of patients with cancer, in part because of personal experiences with family and friends who have struggled with the disease. His overarching goal is to develop a range of effective immunotherapies for solid cancers, based on the powerful CAR T cell platform, with the knowledge that any single therapy will not likely provide durable responses in advanced disease.
City of Hope, in Los Angeles, is a leading research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, it is designated as a comprehensive cancer center, the highest recognition bestowed by the National Cancer Institute. City of Hope is also a founding member of the National Comprehensive Cancer Network, with research and treatment protocols that advance care throughout the US.
City of Hope has been ranked as one of the nation’s “Best Hospitals” in cancer by U.S. News & World Report for over 10 years.
City of Hope has GMP facilities that produces clinical trials materials for many academic centers and is the alpha clinic trials site for CIRM
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MILESTONES
| MILESTONES | MILESTONES | MILESTONES |
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| 1 TECHNOLOGY MILESTONE onCARlytics Phase 1 - 1st Patient Dosed 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 CHECKvacc Cohort 3 Cleared VAXINIA IV Cohort 1 Cleared & IT Cohort 2 Cleared CHECKvacc Publication and Presentation (SABC) HER-Vaxx Publication and Presentation (ESMO Asia & ASCO GI) onCARlytics Publication and Presentation (SITC) onCARlytics Strategic Partnership with Arovella on CAR19-iNKT VAXINIA IV Arm - 1st Patient Dosed HER-Vaxx nextHERIZON Phase 2 - 1st Patient Dosed HER-Vaxx Phase 2 Final OS VAXINIA IT Cohort 1 Cleared VAXINIA IT Arm - 1st Patient Dosed CHECKvacc Cohort 1 and 2 Cleared ~~NEXT 1 -12~~MONTHS |
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| onCARlytics | Phase 1 - 1st Patient Dosed | |
| HER-Vaxx | nextHERIZON Arm 2 Cleared | |
| CHECKvacc | Sponsored Study FDA IND | |
| VAXINIA | Combination – 1st Patient Dosed | |
| onCARlytics | FDA IND |
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| PD1-Vaxx | Combination - 1st Patient Dosed ~~NEXT 1 -1~~ |
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| CHECKvacc | Cohort 3 Cleared | |
| VAXINIA | IV Cohort 1 Cleared & IT Cohort 2 Cleared | |
| CHECKvacc | Publication and Presentation (SABC) | |
| HER-Vaxx | Publication and Presentation (ESMO Asia & ASCO GI) | |
| onCARlytics | Publication and Presentation (SITC) | |
| onCARlytics | Strategic Partnership with Arovella on CAR19-iNKT | |
| VAXINIA | IV Arm - 1st Patient Dosed | |
| HER-Vaxx | nextHERIZON Phase 2 - 1st Patient Dosed | |
| HER-Vaxx | Phase 2 Final OS | |
| VAXINIA | IT Cohort 1 Cleared | |
| VAXINIA | IT Arm - 1st Patient Dosed | |
| CHECKvacc | Cohort 1 and 2 Cleared |
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FINANCIAL SUMMARY
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| FINANCIAL SUMMARY | |
|---|---|
| PUBLIC MARKET OVERVIEW (16 Nov 22) | |
| Share Price | A$0.205 |
| 52 week range | $0.13 - $0.625 |
| Market Capitalisation1 | A$1.29B |
| Cash equivalents (30 Sep 22) | A$163.8M |
| Enterprise Value | A$1.07B |
| TOP 5 SHAREHOLDERS (AS AT 11 NOVEMBER 2022)` | |
|---|---|
| JP Morgan Nominees Australia Pty Limited | 7.10% |
| HSBC Custody Nominees (Australia) Limited | 6.00% |
| Paul Hopper | 5.04% |
| Citicorp Nominees Pty Limited | 4.76% |
| Mann Family | 4.61% |
SHARE PRICE PERFORMANCE
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Note:
- Market capitalisation calculations based on ordinary shares (6.294 bn) only and excludes the dilutive impact of options outstanding (0.543 bn)
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Contact
[email protected] www.imugene.com
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A S X : I M U
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