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IMUGENE LIMITED Investor Presentation 2021

Oct 31, 2021

65124_rns_2021-10-31_f04b10a5-0b73-43c6-9f71-58f4e6556c68.pdf

Investor Presentation

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A S X : I M U

IMUGENE 01 November 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)

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2 0 1 8 Licensed extensive B cell M A Y 2 0 2 1 portfolio and platform from S E P 2 0 2 1 Licensed onCARlytics OSU and Mayo Clinic from City of Hope Entered the comprising of PD1, HER1, invented by Dr Y Fong, S&P/ASX 300 HER2, HER3, VEGF, Dr S Priceman & Index IGF-1R, CD28 Dr A Park 2 0 1 5 Leslie Chong N O V 2 0 2 1 2 0 1 3 2 0 1 9 from Genentech Strategic Partnership Paul Hopper built joined Imugene Completed the A U G 2 0 2 1 with Eureka Imugene around a 2 0 1 7 acquisition of a prolific Strategic Partnership technology that HER-Vaxx, our HER-2 oncolytic virus from with Celularity originated from the City of Hope invented by Medical University of targeted B Cell Vienna Immunotherapy Dr Yuman Fong entered the clinic

3

Partnership Highlights

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  • Strategic Research Partnership Eureka Therapeutics, Inc. for the Treatment of Solid Tumours

  • Collaboration will explore the therapeutic potential of a combination of Imugene’s CD19 oncolytic virus onCARlytics in combination with Eureka’s anti-CD19 ARTEMIS[®] T-cell therapy for the treatment of solid tumours.

  • In head-to-head pre-clinical studies against CAR-T cells, ARTEMIS[®] T-cells demonstrated superior efficacy, enhanced tumour infiltration, and less T-cell exhaustion.

  • In the clinic, ARTEMIS[®] T-cells have demonstrated reduced cytokine release syndrome (CRS) and other cytokinerelated toxicities compared to CAR-T cells, potentially improving the efficacy and safety of a combination approach

  • Imugene’s novel strategy to treat solid tumors uses onCARlytics to prime the tumor cells for destruction by eliciting the expression of a validated tumor marker, CD19, then used as a target for CD19 cellular therapy

  • Nonclinical in vitro and in vivo combination studies with ARTEMIS[®] and onCARlytic to commence

4

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Developing Safer and More Effective T-cell Therapies for Solid Tumors

Dr. Cheng Liu President and CEO

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Leader in Solid Tumor T-cell Therapy

Proprietary ARTEMIS[®] technology empowering T-cells to infiltrate solid tumors

Headquartered in San Francisco Bay Area

Lead clinical assets to treat liver cancer (HCC) in Phase I/II trials

Multiple near-term clinical milestones

Multiple partnerships/collaborations

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ARTEMIS is a registered trademark owned by Eureka Therapeutics, Inc.

6

Eureka Ranks in Top 10 CAR-T Patent Assignees Worldwide

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9
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(No. 4 Among Industries)

Top CAR-T Cell Patent Assignee Worldwide 2020

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7

Eureka ARTEMIS[®] Technology Platform

ARTEMIS

Superiority to CAR

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ARTEMIS receptor is primarily localized in microvilli.

(Collaboration: Alice Liang, Ph.D. Director of Microscopy Laboratory, NYU Langone Health NYU School of Medicine)

  • ARTEMIS T-cell therapy is clinically validated in patients

  • ARTEMIS vs. CAR-T

  • Superior efficacy

  • Enhanced tumor infiltration

  • Less T cell exhaustion

  • Reduced Cytokine Release Syndrome (CRS) and cytokine related toxicities

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8

Preclinical Data Demonstrates Superior Safety/Efficacy Profile Compared to CAR T

CD19 ARTEMIS[® ] T cells release less CRS-related cytokines than CAR-T, including IL-6

CD19 ARTEMIS[®] T cells shows matching efficacy in mouse model (Raji)

Mock CD19-CAR CD19 ARTEMIS[®]

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CAR-T
ARTEMIS
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Xu et al., Cell Discovery , 2018

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9

Tumor Infiltration - ARTEMIS vs. CAR-T cells

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Mock CAR
Intravenous (IV)
T-cell infusion
Subcutaneous
Tumor
100
armed with tumor infiltration technology
than control and CAR-T cells.
50
0
Mock GPC3-CARGPC3-ARTEMIS
CD3+ Cell Percentage (%)
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ARTEMIS

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Scans of tumor tissue stained with T-cell marker CD3 show ARTEMIS T cells armed with tumor infiltration technology went deeper into the solid tumor than control and CAR-T cells.

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ARTEMIS Construct Validated by Independent Researchers

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Published work with Grupp’s team

Xu et al. Cell Discovery (2018) 4:62

ARTEMIS vs. CAR-T cells

  • Potent anti-tumor activity

  • Better safety profile

  • Longer durability with less exhausted phenotype

Stephan A. Grupp, MD, PhD

  • Delivered CAR T-cell therapy to the first pediatric patient in the world (Emily Whitehead).

  • Led the first multicenter global study of Kymriah[®] , which became the first CAR-T therapy to receive approval by the FDA.

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10 [11]
700 Mock * 4000 CAR
10 [10]
600 CAR ARTEMIS™
10 [9] 500 ARTEMISÔ 3000
Dose
400
10 [8]
2000
300

10 [7]
200 1000

10 [6]
100
10 [5] 0 0
D1 D9 D15
0 5 10 15 20 25 30 35 IL-2 IL-10 IFN- g TNF- a
Days post implantation Days (D) Post T cell infusion
Mock CAR ARTEMISÔ
PD-1 MFI
Total Flux (p/s) mean +/- SEM Serum Cytokines (pg/mL)
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11

Eureka Pipeline

PROGRAM (TARGET)/INDICATION DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PARTNERS
ET140203 (AFP)
Adult HCC/Liver Cancer (ARYA-1)
/
/
/
ET140203 (AFP)
Pediatric Liver Cancers (ARYA-2)
ECT204 (GPC3)
HCC/Liver Cancer (ARYA-3)
Undisclosed Target
Mesothelioma, Ovarian & Pancreatic Cancers
Undisclosed Target
Lung, Breast & Ovarian Cancers
Partnered Asset (BCMA)
Multiple Myeloma
Partnered Asset (GPRC5D)
Multiple Myeloma
Partnered Asset (MUC16)
Ovarian Cancer
Partnered Asset (WT1)
Ovarian Cancer
Partnered Asset (GPRC5D), non-CAR use
Multiple Myeloma
Partnered Asset (AFP)
Adult HCC, Greater China and ASEAN
Partnered Asset (GPC3)
Adult HCC, Greater China and ASEAN
Partnered Asset (CD19), Oncolytic Virus
Solid tumors

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Collaboration program.

Wholly-owned program.

The CAR T Solid Tumour Challenge & Imugene’s Solution

Chimeric Antigen Receptor (CAR) T cell therapy has had limited activity in solid tumours, largely due to a lack of selectively and highly expressed surface antigens, such as the blood B cell antigen CD19.

CD19 CAR T Cells

CD19 Targeting domain

Solid Tumour

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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

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 with onCARlytics (CF33-CD19) presents CD19 targets on solid tumours

OV generated CD19

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Mechanism of Action: How does it work?

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onCARlytics makes solid tumours “seen” by CD19 directed CAR T

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1
4
2
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  1. OnCARlytics infects tumour cells

  2. Virus replication and production of CF33-CD19 on the cell surface enabling CD19 CAR T cell targeting

  3. Tumour cell lysis leads to viral particle release and the combination promotes endogenous immune cell recruitment to tumours

  4. Released viral particles re-initiate virus infection of surrounding tumour cells.

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3
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onCARlytics delivers CAR Targets to “ targetless ” solid tumours

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J2R
Vacci ni a O ncol yti c Virus
CF33-(SE)hCD19t P SE Vaccin ia Vir us
hCD19t
CD19
DAPI
MOI 0.025 MOI 1 MOI 0 CD19t
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onCARlytics (CF33-CD19) infects a wide array of solid tumour cell lines, with dose-dependent CD19 cell surface expression

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100
Capan-1 (pancreas)
80
DU145 (prostate)
60
OV90 (ovarian)
40
Pan c -1 (pancrea s)
20
UM- SCC -1 (head and neck)
0
UM-S CC -47 (head and neck)
U25 1 T ( glioma)
Multiplicity if infection
0.001 0.01 0.1 1 10
CD19t (%)
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Combination of onCARlytics (CF33-CD19) and ~~CD19~~ -CAR T cells promotes tumour regression in ~~xenog~~ raft model of TNBC

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i.t.10M i.t. 5M Mock or
pfu OV19t CD19-CAR T cells
s.c.
MDA-MB-468
OV T cells
600
400
200
p < 0.05
0
0 20 40 60 80
Days post tumor injection
No treatment OV19t alone
Mock alone OV19t + Mock
CAR alone OV19t + CAR
)
3
Tumor Volume (mm
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Park et al. Science Translational Medicine 2020

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
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

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Financial Summary

Public Market Overview

Public Market Overview
Share Price1 A$0.485
52 week range 0.052 - 0.515
Market Capitalisation2 A$2.73B
Cash equivalents (30 Sept 21) A$112.2M
Enterprise Value A$2.617B
Top 5 Shareholders(as at September 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 3 months)

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Note:

  1. As of 29 Oct 2021

  2. Market capitalisation calculations based on ordinary shares (5.46 bn) only and excludes the dilutive impact of options outstanding (0.64 bn)

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A S X : I M U

IMUGENE LIMITED www.imugene.com [email protected]