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IMUGENE LIMITED — AGM Information 2020
Nov 23, 2020
65124_rns_2020-11-23_a8649e0d-5f3b-4666-958c-3c843e80a40b.pdf
AGM Information
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Imugene AGM
24[th] November 2020
SITUATION ANALYSIS
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Market Capitalisation 2015 - 2020 $528.4
$500
Share Price 2015 - 2020
14.0
$400
12.0
10.0
8.0
$300
6.0
4.0
$200
2.0
$140.0
0.0
2015 2016 2017 2018 2019 2020
$100 Year
$64.80
$37.80 $39.20
$18.70
$-
2015 2016 2017 2018 2019 2020
Year
Millions
Share Price ¢
Market Cap. $AUD
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I m u g e n e L i m i t e d A G M , 2 4[t h] N o v e m b e r 2 0 2 0
ACQUISITION OF TECHNOLOGY
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University of Vienna Ohio State University City of Hope
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I m u g e n e L i m i t e d A G M , 2 4[t h] N o v e m b e r 2 0 2 0
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Experienced management team which have significant clinical ~~development expertise~~
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Dr Nick Ede
Dr Rita Laeufle
MELBOURNE, AU
SAN DIEGO, USA
Chief Technology Officer
Chief Medical Officer
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27+ years of oncology experience in academia and industry
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25+ years peptide vaccine and drug development
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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 CEO Adistem and CEO of Mimotopes , VP Chemistry Chiron (now Novartis), Research Fellow CRC Vaccine Technology
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- Former CMO at Oncolytics Biotech, Ex Genentech, Ex Hoffmann-La Roche, and Ex Novartis
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Dr Anthony Good SYDNEY, AU
Bonnie Nixon
SYDNEY, AU
VP of Clinical Research
Project Manager
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20+ years experience in global clinical development
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5+ years of oncology
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experience across Phase I – IV clinical trials
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Integral to the development of significant new medicines including Viagra, Revatio, Lipitor, and Somavert
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Ex North America Study Manager at Genentech, Ex Roche Clinical Operations Australia
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Ex Pfizer Global Research and Development, Ex Covance Clinical Services
Imugene has a team with oncology drug development experience
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I m u g e n e L i m i t e d A G M , 2 4[t h] N o v e m b e r 2 0 2 0
2020 YEAR IN REVIEW
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Successful integration of City of Hope Oncolytic Virus, CF33
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Establishment of OV SAB , chaired by Prof Yuman Fong and appointment of
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Professor Adusumilli & Professor Auer
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CF33 completes clinical grade GMP manufacturing
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HER-Vaxx Patent granted in the USA
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PD1-Vaxx clinical grade GMP manufacturing complete
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HER-Vaxx Phase 2 Study 1[st] and 2[nd] IDMC Completed
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Successful Pre-IND FDA meeting for guidance on VAXINIA Clinical Development Plan
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US FDA IND Approval & Australia HREC approval for PD1-Vaxx Phase 1 Study
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Appointment of Dr Rita Laeufle as the CMO
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I m u g e n e L i m i t e d A G M , 2 4[t h] N o v e m b e r 2 0 2 0
CF33 OV PUBLICATIONS IN MAJOR CANCER JOURNALS
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INTERNATIONAL JOURNAL
of Molecular Sciences
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MDPI Cancers Journal
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NATURE Cancer Gene Therapy
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OncoImmunology
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Published: 3 October 2020
Vitamin D as a Primer for Oncolytic Viral Therapy in Colon Cancer Models
Published: 26 June 2020
Optimizing Oncolytic Viral Design to Enhance Antitumor Efficacy: Progress and Challenges
Issued: April 2020
A chimeric poxvirus with J2R (thymidine kinase) deletion shows safety and antitumor activity in lung cancer models
Published: 24 Feb 2020
Oncolytic poxvirus CF33-hNIS-ΔF14.5 favorably modulates tumor immune
microenvironment and works synergistically with anti-PD-L1 antibody in a triple-negative breast cancer model
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B-CELL IMMUNOTHERAPY PUBLICATIONS IN MAJOR CANCER JOURNALS
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OncoImmunology
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Future Oncology
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Frontiers in Immunology
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Published: 01 Oct 2020
Published: 21 June 2020
Published: 17 June 2019
Immunogenicity and antitumor efficacy of a novel human PD-1 B-cell vaccine (PD1-Vaxx) and combination immunotherapy with dual trastuzumab/pertuzumab-like HER-2 B-cell epitope vaccines (B-Vaxx) in a syngeneic mouse model
B-cell epitope peptide cancer vaccines: a new paradigm for combination immunotherapies with novel checkpoint peptide vaccine
A New Strategy Toward B Cell-Based Cancer Vaccines by Active Immunization With Mimotopes of Immune Checkpoint Inhibitors
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I m u g e n e L i m i t e d A G M , 2 4[t h] N o v e m b e r 2 0 2 0
IMUGENE PRESENTATIONS AT AACR
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PD1-Vaxx
VAXINIA
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I m u g e n e L i m i t e d A G M , 2 4[t h] N o v e m b e r 2 0 2 0
HER-Vaxx PHASE 2: INTERIM ANALYSIS
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Efficacy Outcome Overview
OS ITT * Endpoint (Primary) Chemo+ Treatment Chemo HER-Vaxx All Patients n=27 (at data cut off) 13 14 Events 8 4 Hazard Ratio (HR) 0.418 2-sided 80%CI (0.186,0.942) Log-rank Test (1-sided p-value)* .083[+]
*Overall Survival Intent to Treat
**Death
***Pre-specified alpha at 0.10
- Statistically Significant
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HER-Vaxx PHASE 2: INTERIM ANALYSIS
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Safety Overview - Patients with at least one TEAE*
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Chemo + HER-Vaxx Chemo alone
Total at data cut off
% %
Grade 3 42.9% 30.8%
Grade 4 0% 15.4%
Grade 5 0% 7.7%
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*Treatment Emergent Adverse Events showed no added Toxicity to HER-Vaxx and Chemo arm independent of causality
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HER-Vaxx PHASE 2: INTERIM ANALYSIS
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Interim analysis showed statistically significant overall survival Hazard Ratio (HR) of 0.418 (80% 2- sided CI: 0.186, 0.942); HER-Vaxx showed a reduced risk of death of 58.2% in the HER-Vaxx plus chemotherapy group as compared to chemotherapy alone.
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The median overall survival (OS) for patients receiving HER-Vaxx plus chemotherapy was 14.2 months, compared to 8.8 months in patients treated with chemotherapy alone.
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The Independent Data Monitoring Committee (IDMC) confirms a favourable survival outcome with no added toxicity for HER-Vaxx combined with SOC chemotherapy over chemotherapy alone and advised to reduce the overall number of patients to ~34 and number of required events given the strong signal that it would be considered unethical to enroll 68 as originally planned.
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The IDMC agreed, that the safety of the study is favorable with no added toxicity for the combination of HER-Vaxx and SOC chemotherapy versus SOC chemotherapy alone.
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The IDMC agreed that the presented data is strongly encouraging to conclude that the combination of HER-Vaxx and SOC Chemotherapy is safe.
The Phase 2 data represent a clinical proof-of-concept signal for HER-Vaxx when added to chemotherapy and indicate that B-cell activating immunotherapy vaccines can induce clinically active antibody responses.
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MULTIPLE NEAR & MEDIUM TERM VALUE INFLECTION POINTS
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PD1-Vaxx
VAXINIA HER-Vaxx CHECKvacc
VAXINIA 1st Patient Dosed CHECKvacc TNBC IST 1[st ] Patient Dosed VAXINIA FDA IND Clearance PD1-Vaxx Maximum Feasible Dose Identified PD1-Vaxx 3rd cohort escalation HER-Vaxx Phase 2 Final Analysis HER-Vaxx Phase 2 Enrollment completed PD1-Vaxx 2[nd] cohort escalation CHECKvacc FDA IND Clearance VAXINIA CRO selected PD1-Vaxx 1st patient Dosed HER-Vaxx Phase 2 Second IDMC
Next 12 months
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I m u g e n e L i m i t e d A G M , 2 4[t h] N o v e m b e r 2 0 2 0
FINANCIAL SUMMARY
| Public Market Overview | |
|---|---|
| Share Price1 | A$0.115 |
| Market Capitalisation2 | A$528.4M |
| Cash equivalents (30 Sep 20) | A$26.6M |
| Enterprise Value | A$501.8M |
| Top 5 Shareholders(as at November 2020) | |
| Richard Mann and Assoc. | 5.66% |
| Paul Hopper | 3.86% |
| National Nominees Limited | 2.77% |
| Dr Nicholas Smith | 2.57% |
| HSBC Custody Nominees (Australia) | 1.82% |
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Share Price Performance (last 6 months)
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Note:
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As of 23 November 2020
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Market capitalization calculations based on ordinary shares (4.59bn) only and excludes the dilutive impact of options outstanding (842m)
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I m u g e n e L i m i t e d A G M , 2 4[t h] N o v e m b e r 2 0 2 0
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Leslie Chong Managing Director & CEO [email protected] +61 458 040 433