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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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ACQUISITION OF TECHNOLOGY

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University of Vienna Ohio State University City of Hope
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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

  • 27+ years of oncology experience in academia and industry

  • 25+ years peptide vaccine and drug development

  • Clinical development experience with bevacizumab, trastuzumab, abituzumab, CPIs and oncolytic viruses from Phase I – to post marketing Phase IV

  • 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

  • 20+ years experience in global clinical development

  • 5+ years of oncology

  • experience across Phase I – IV clinical trials

  • Integral to the development of significant new medicines including Viagra, Revatio, Lipitor, and Somavert

  • Ex North America Study Manager at Genentech, Ex Roche Clinical Operations Australia

  • Ex Pfizer Global Research and Development, Ex Covance Clinical Services

Imugene has a team with oncology drug development experience

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2020 YEAR IN REVIEW

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  • Successful integration of City of Hope Oncolytic Virus, CF33

  • Establishment of OV SAB , chaired by Prof Yuman Fong and appointment of

  • Professor Adusumilli & Professor Auer

  • CF33 completes clinical grade GMP manufacturing

  • HER-Vaxx Patent granted in the USA

  • PD1-Vaxx clinical grade GMP manufacturing complete

  • HER-Vaxx Phase 2 Study 1[st] and 2[nd] IDMC Completed

  • Successful Pre-IND FDA meeting for guidance on VAXINIA Clinical Development Plan

  • US FDA IND Approval & Australia HREC approval for PD1-Vaxx Phase 1 Study

  • Appointment of Dr Rita Laeufle as the CMO

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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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IMUGENE PRESENTATIONS AT AACR

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PD1-Vaxx

VAXINIA

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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.

  • 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.

  • 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.

  • 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.

  • 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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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:

  1. As of 23 November 2020

  2. Market capitalization calculations based on ordinary shares (4.59bn) only and excludes the dilutive impact of options outstanding (842m)

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Leslie Chong Managing Director & CEO [email protected] +61 458 040 433