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IMUGENE LIMITED Investor Presentation 2021

Jun 10, 2021

65124_rns_2021-06-10_e352a96e-55a8-40e8-87e2-c126ea9b85ba.pdf

Investor Presentation

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A S X : I M U

IMUGENE

11 June 2021

Disclaimer

  1. 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.

  2. 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.

  3. 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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  1. Neither the Company nor any of its directors, officers, employees, advisers, 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.

  2. Any opinions expressed reflect the Company’s position at the date of this presentation and are subject to change

  3. 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.

2

Introduction to Imugene

Imugene is a biotech company headquartered in Australia and publicly traded on the Australian Securities Exchange (ASX:IMU)

2 0 1 7

HER-Vaxx, our HER-2 targeted B Cell Immunotherapy entered the clinic

2 0 1 9

Completed the acquisition of a prolific oncolytic virus from City of Hope invented by Dr Yuman Fong

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M A Y 2 0 2 1

2 0 1 3

Paul Hopper built Imugne around a technology that originated from the Medical University of Vienna

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2 0 1 5

Leslie Chong from Genentech joined Imugene

2 0 1 8

Licensed extensive B cell portfolio and platform from OSU and Mayo Clinic comprising of PD1, HER1, HER2, HER3, VEGF, IGF-1R, CD28

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Licensed onCARlytics from City of Hope invented by Dr Y Fong, Dr S Priceman & Dr A Park

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3

Investment Highlights

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  • Three novel technology platforms: Oncolytic virotherapies, onCARlytics in cellular therapy and B-Cell activating immunotherapies

  • B-Cell Technologies: HER-Vaxx Phase 2 in gastric cancer and PD1-Vaxx in NSCLC

  • CF33 Oncolytic Virotherapies: 2 Phase 1 Clinical Trials

  • OnCARlytics: Pre-clinical Toxicology Trials

  • Highly experienced team in oncolytic virus and cellular therapies

  • Significant news flow with multiple near & medium term valuation inflections

4

onCARlytics Acquisition

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Worldwide exclusive license
to novel technology which
provides Imugene’s CF33
oncolytic virus the ability to
utilize CD19 CAR T therapies
against solid tumours
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The four FDA approved CD19 CAR T drugs only work in blood cancers- solid tumours remain the holy grail

This technology makes the treatment of solid tumours by CAR T drugs viable

Offers Imugene numerous partnering or collaboration opportunities for both approved and in-development CAR Ts, bispecifics, ADC’s etc

Enhancement of our scientific team to spearhead clinical development of onCARlytics

Compelling pre-clinical activity

in TNBC, colorectal, pancreatic, prostate, ovarian, head and neck and glioma cancers when combining onCARlytics (CF33-CD19) with CD19 CAR T

Phase 1 CF33 oncolytic virus studies, commencing shortly will accelerate development of onCARlytics

Attractive industry standard licensing terms and royalty rates

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OnCARlytics Phase 1 study to commence in 2022

Robust intellectual property with long patent life

Four-year Sponsored Research Agreement with City of Hope Cancer Centre to further develop the technology

5

Three Novel Technology

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Platforms

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onCARlytics
CF33 Oncolytic Virus B Cell Immunotherapy
CHECKvacc VAXINIA
CF33-CD19 CAR T Combination Therapy HER-Vaxx PD1-Vaxx
“Armed” Virus Parental Virus
B-Vaxx, PDL1-Vaxx, LAG3-Vaxx,
TIM3-Vaxx, VEGF-Vaxx, CTLA4-Vaxx etc
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6

Imugene’s Deep Pipeline

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Pre-clinical Clinical
development
Phase 1
Clinical
development
Phase 1
Clinical
development
Phase 2
Clinical
development
Phase 2
Clinical
development
Phase 2
Clinical
development
Phase 2
Key Data / Results Intellectual
Property
onCARlytics
(CF33-CD19)

Compelling pre-clinical activity in multiple cancers when combining onCARlytics (CF33-CD19)
with CD19 CAR T

Combination of onCARlytics and CD19 CAR T cells promotes endogenous memory T cell
responses

No infection in normal cells
Expiring 2038
VAXINIA
(CF33-hNIS)
Metastatic
Advanced solid
tumours

CF33 has shown strong anti tumour responses in preclinical studies

Inhibition of tumour growth in nearly all NCI60 models in TNBC, Lung, Pancreatic etc.

Signs of increased tumour growth inhibition with CF33 + anti PD-L1
Expiring 2037
CHECKvacc
(CF33-hNIS-
aPD-L1)
Triple negative
breast cancer

Pre-clinical studies showed cancer growth inhibition was better than compared to Amgen or

Genelux oncolytic virus

Potentially solves the industry problem of additive toxicity of combined checkpoint inhibitors if
safety of CF33 is maintained in combination
Expiring 2037
HER-Vaxx
(HER-2)
Gastric

Successful completion of Phase 1b trials, published in AACR, ASCO GI, ASCO, ESMO GI, ESMO,
ESMO Asia 2019

Strong trial results with no safety or toxicity issues, all patients had increased antibody
response, 11/14 evaluable patients with encouraging clinical responses

Phase 2 Interim data: 0.418 HR (80% 2-sided CI: 0.186, 0.942); 14.2 months HER-Vaxx +
chemo compared to 8.8 months chemo alone
Expiring 2036
PD1-Vaxx
(PD-1)
Lung

PD1-Vaxx has shown encouraging response in preclinical studies

Strong inhibition of tumour growth in mouse models of colorectal cancer (outperformed industry
standard mouse PD-1 mAb)

Signs of increased tumour growth inhibition when co-administered with B-Vaxx

FDA IND approval

First NSCLC patient dosed December 2020
Expiring 2037
7

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B-Cell Immunotherapies

8

B Cell Based Antibodies Have Distinct Advantages To Existing Treatments

B cell Vaccines offer a unique opportunity to intervene at multiple points in the immune system and create immune memory which N A T U R A L B C E L L D E R I V E D enhances durability of response. A N T I B O D I E S Stimulates the immune system to produce Safety Abs, which may be potentially safer Polyclonal Ab response reduces risk of Efficacy resistance and potentially increases efficacy Antibodies continuously produced with Durability lasting immune response to potentially inhibit tumor recurrence Potentially low numbers of vaccinations Usability required per year Cost Low cost of production enables greater pricing flexibility facilitating combination

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M O N O C L O N A L A N T I B O D I E S

Synthetic Ab, with side effects (including ventricular dysfunction, CHF, anaphylaxis, immune mediation) Monoclonal Ab – may develop anti-drug antibodies Half life necessitates recurrent dosing Requires regular infusion Expensive course of treatment >US$100K per year

9

HER-Vaxx Phase 2 Recruitment Complete

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  • Trial Patients Study Primary Endpoints • • • Phase 2 HER-2+++ Randomized Overall survival

  • • • Open label HER-2++ FISH/CISH +ve HER-Vaxx in combination

  • • • Asia Advance or metastatic with standard of care Secondary Endpoints

  • • Eastern Europe Gastric Cancer chemotherapy • Progression-free

  • • • India Stage IIIb/IV Or survival • 36 patients in two arms Standard of care chemo: • Safety and Tolerability Cisplatin and 5FU or • Immune response

  • capecitabine or oxaliplatin

First patient dosed March 2019/Last patient enrolled Jan 2021

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10

AACR 2021 Presentation Poster

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11

AACR 2021 Presentation Highlights

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The AACR presentation highlights and presents the following new data:

  • Treatment with HER-Vaxx clearly demonstrates that all patients develop high levels of HER2-specific antibodies early in the treatment protocol.

  • Analysis of the antibody data reveals high levels are maintained during the treatment and maintenance phases, with only minimal booster injections of HER-Vaxx required to maintain the high levels .

  • The constant and high HER2 antibody levels correlate with the early separation of the Kaplan Meier (KM) Curves for overall survival (OS) and progression free survival (PFS) clinical trial endpoints. The Kaplan Meier Curve provides a recognised statistical estimation of the survival function which visually represents the probability of an event occurring for each treatment arm at a respective time interval.

  • Overall, this interim data is suggestive that the treatment is effective and well tolerated with an overall survival benefit that is superior to chemotherapy alone.

Final tumour response, correlation of antibodies with tumour response, and final PFS and OS data is expected to read out in 2021.

PFS Endpoint Events met on 21st April 2021; Top Line Data expected July 2021

12

PD1-Vaxx Phase 1 Study Design

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M O N O T H E R A P Y D O S E C O M B I N A T I O N E S C A L A T I O N
P H A S E E S C A L A T I O N & E X P A N S I O N
Part 1 Part 2 (planned)
Indication Non-small cell lung cancer expressing PD-L1
Objectives Safety & Tolerability, Immunogenicity, OBD Monotherapy
# Patients Approx. 12-22 Approx. 12-30
Site Location Australia & USA
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PD1-Vaxx Phase 1 Study Design

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Current Status
1 [st] Patient Dosed Cohort 1 Cleared 1 [st] Patient Dosed Cohort 3 Cleared,
Cohort 2 Cleared 1 [st] Patient Dosed
Cohort 1 Cohort 2 RP2D & Expansion
Cohort 3
Opened
30 Nov 2020 Jan 2021
Phase 2 – Expansions Assumption HACKENSACK UNIVERSITY
Open
MACQUARIE UNIVERSITY
Open
CHRIS O’BRIEN LIFEHOUSE
Open
Ohio State University
Open
CABRINI MALVERN
Open
Mayo Clinic
Open
14
M I L E S T O N E S
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Oncolytic Virus CF33

15

CF33 Mechanism of Action

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Step 1:
Virus enters cell
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Step 2: Step 3:
Virus duplicates itself Cell explodes,
releasing thousands of
brand new virus particles
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HOW A VIRUS KILLS A CELL

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  • Direct infection, replication within and cancer cell killing

  • Viral infection increases local check point targets (PD-1, PD-L1, CTLA4 etc)

  • Cell death is immunogenic [surface expression of calreticulin, release of adenosine triphosphate (ATP) and release of high mobility group box 1 (HMGB1)]

  • Local anti-PD-L1 expression may allow enhancement of anti-cancer immunotherapy

  • Human sodium iodine symporter (hNIS) expression allows additional use of[131] Iodine or[188] Rhenium killing of infected cells and adjacent cells

16

CHECKvacc “Armed” Virus

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Phase 1 Triple Negative Breast Cancer Study – GMP Manufacturing Complete

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COHORT | 3-6 PATIENTS
COHORT | 3-6 PATIENTS
Metastatic Triple
Negative Breast COHORT | 3-6 PATIENTS
Cancer
COHORT | 3-6 PATIENTS
COHORT | 3-6 PATIENTS
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IDENTIFY
Recommended
Phase 2 Dose
(RP2D) RP2D EXPANSION
Based on: 12 PATIENTS
 Safety
 Immunogenicity
 Tumour Response
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 Disease of need

  • 8-13 month survival for metastatic disease with few treatments

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Indication TNBC

  • Potential target for immunotherapy

  • Expresses PD1, PD-L1

  • Treatment responses to Atezolizumab (JAMA Oncology, 5:74, 2019)  1[st] line: 24%; 2[nd] line: 6%

  • Approved by FDA 8-March, 2019

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FDA IND CHECKvacc: CF33-hNIS-aPDL1 N Part 1=18-24 ; Part 2=12 Location Single Center: COH Admin Route Intratumoral (IT)

  • Potential for registration in well-designed, randomized P2 study

17

VAXINIA Phase 1 MAST Study Metastatic Advanced Solid Tumours

Part 2: VAXINIA + SOC IO* Combination Dose Escalation

Part 1: VAXINIA Monotherapy Dose Escalation

Dose Admin IT AND IV IT Administration Dose COHORT | 3-6 COHORT | 3-6 IT AND IV IDENTIFY Head & Neck, Admin PATIENTS PATIENTS MONOTHERAPY Advanced COHORT | 3-6 COHORT | 3-6 COHORT | 3-6 COHORT | 3-6 Melanoma, TNBC PATIENTS PATIENTS Maximum Feasible PATIENTS PATIENTS Does (MFD) COHORT | 3-6 COHORT | 3-6 IV Administration PATIENTS PATIENTS Based on: COHORT | 3-6 COHORT | 3-6 Head & Neck, PATIENTS PATIENTS Advanced COHORT | 3-6 COHORT | 3-6  Safety PATIENTS PATIENTS  Immunogenicity Melanoma, TNBC,  Tumour NSCLC, Bladder, COHORT | 3-6 COHORT | 3-6 Response Gastric, Colorectal, PATIENTS PATIENTS RCC Phase Phase 1 IT: Head & Neck, Advanced Melanoma, TNBC Indication IV: Head & Neck, Advanced Melanoma, TNBC, NSCLC, Bladder, Gastric, Colorectal, RCC Objectives Safety & MFD No. of Patients Approx. 60-120 Site Location USA

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IDENTIFY COMBINATION

DLT cleared VAXINIA monotherapy dose combined with IO in dose escalation cohorts. Select IO* Combination for recommended phase 2 dose (RP2D) based on:  Safety

  • Immunogenicity

  • Tumour PD and target Signals

  • *IO: Immunotherapy

  • *DLT: Dose Limiting Toxicity

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N E W C O N C E P T

Utilise OV’s as a delivery vector to deliver CD19 antigen to solid tumour cells

CD19 Targeting domain

Solid Tumour

CD19 CAR T Cells

Engineer Imugene’s CF33 to infect solid tumour cells and insert CD19 transgene to enable presentation of CD19 over the tumour cells during tumour cell infection, onCARlytics (CF33-CD19)

Combination use of autologous or allogeneic CD19 CAR Ts (eg. Novartis KYMRIAH®) with onCARlytics (CF33CD19) presents CD19 targets on solid tumours

OV generated CD19

19

Four FDA Approved CD19 CAR T’s

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Approved and in-development autologous or allogeneic CD19 CAR Ts can be partnered with Imugene’s onCARlylics for treating solid tumours:

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21

Intellectual Property

Intellectual
Property
F O U N D A T I O N P A T E N T ( 2 0 3 8 )
PCT US2019/033030
Title Oncolytic virus expressing a CAR T
cell target and uses thereof
Inventors Fong, Priceman, Forman, Chen
& Park
Assignee City of Hope
Primary Date 11 August 2017
International Publication 14 February 2019
Expiration Date* 2038

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PCT application filing date was 10/8/2018 and *estimated expiration date is in late 2038. The patent application includes both composition of matter and method of use. It is currently pending with the opportunity to secure worldwide rights. International search report was favorable for composition of matter.

22

Milestones

Technology Milestone onCARlytics 1[st] Patient Dosed Monotherapy onCARlytics FDA IND Clearance PD1-Vaxx Combination RP2D onCARlytics GLP Toxicology Study VAXINIA 1st Patient Dosed PD1-Vaxx Expansion combination study FPI HER-Vaxx Phase 2 Final Analysis VAXINIA FDA IND Clearance onCARlytics FDA Pre-IND Meeting PD1-Vaxx Maximum Feasible Dose Identified HER-Vaxx OS Endpoint Met onCARlytics GMP manufacturing for pre-clinical toxicology & Phase 1 study CHECKvacc TNBC IST 1st Patient Dosed HER-Vaxx PFS Top line Results CHECKvacc FDA IND Clearance

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~~Next 12~~ -24 months

23

Financial Summary

Public Market Overview

Share Price1 A$0.325
Market Capitalisation2 A$1.604B
Cash equivalents (31 Mar 21) A$29.4M
Enterprise Value A$1.575B
Top 5 Shareholders(as of May 2021)
Mann Family 5.93%
Paul Hopper 4.09%
Dr Nicholas Smith 2.40%
Ms Leslie Chong 1.56%
Private Portfolio Management 1.35%

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Share Price Performance (last 6 months)

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Note:

  1. As of 26 May 2021

  2. Market capitalization calculations based on ordinary shares (4.877 bn) only and excludes the dilutive impact of options outstanding (578m) as of 25 May 2021

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