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HARNESSING B-CELLS FOR CANCER IMMUNOTHERAPYLeslie ChongManaging Director & Chief Executive OfficerOctober 2018

DevelopingCancerImmunotherapies

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2

Notice: Forward Looking Statements

Any forward looking statements in this presentation have been prepared on the basis of a number of

assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about

future events are subject to risks, uncertainties and other factors, many of which are outside Imugene

Limited’s control. Important factors that could cause actual results to differ materially from any assumptions

or expectations expressed or implied in this brochure include known and unknown risks. As actual results may

differ materially to any assumptions made in this brochure, you are urged to view any forward looking

statements contained in this brochure with caution. This presentation should not be relied on as a

recommendation or forecast by Imugene Limited, and should not be construed as either an offer to sell or a

solicitation of an offer to buy or sell shares in any jurisdiction in which it would be a contravention of

applicable law.

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Experienced Management & Board

§ Meeting milestones

§ Successful M&A activity

Imugene B-cell Vaccine Pipeline

Broadened and strengthened clinical

programs globally, including U.S. and

European centres

§ HER-Vaxx milestones of Phase 1b

recruitment completed; Phase 2

activity commenced

§ B-Vaxx Phase 2 ongoing

§ KEY-Vaxx pre-clinical work started

Synergistic Technology Licensed from Ohio State University and The Mayo

Clinic

Full spectrum of indications and

targets to choose from, including

checkpoint inhibitors and combination

therapies

EXECUTIVE SUMMARY

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Leslie Chong (Sydney, Australia)Managing Director & Chief Executive Officer• Over 20 years of oncology experience in Phase I – III of clinical program

development• Leadership role involvement in two marketed oncology products• Previously Senior Clinical Program Lead at Genentech, Inc., in San

Francisco

A TEAM WITH A TRACK RECORD IN DRUG DEVELOPMENT

Dr Axel Hoos (Philadelphia, U.S.A.)Non-Executive Director• Senior Vice President and Head of Oncology at GSK• Former Medical Lead for Yervoy, the first survival improving medicine in

Immuno-Oncology• Chairman of the BoD of the Sabin Vaccine Institute• Co-Chair of the Cancer Immunotherapy Consortium Think-Tank

Paul Hopper (Sydney, Australia)Executive Chairman• International & ASX biotech capital markets experience particularly in

immuno-oncology & vaccines• Former Chairman of Viralytics, Founder & Director of Prescient, Founder

of Imugene & Polynoma LLC, former Director pSivida, Somnomed & Fibrocell Science

Dr Mark Marino (California, U.S.A.)Chief Medical Officer• Over 28 years of experience in drug development• Former CMO of Cytori, Head of Clinical Pharmacology at Eisai and Roche,

Head of Research and Early Development at Mannkind, VP Clinical Development at Daiichi

Mr. Charles Walker (Brisbane, Australia) Non-Executive Director• Experienced listed biotech CEO and CFO (ASX;ACL and ASX:IMU)• Experienced in financial markets including executing 55 international tech

corporate transactions• Clinical experience includes managing pipeline of drugs in all stages form

discovery, through to Phase III to launched products

Dr Nick Ede (Melbourne, Australia)Chief Technology Officer• Over 25 years peptide vaccine and drug development• Former CEO Adistem, CEO Mimotopes• VP Chemistry Chiron (now Novartis), Research Fellow CRC Vaccine

Technology

Dr Anthony Good (Sydney, Australia)Vice President of Cl inical Research• Over 20 years global clinical development experience.• Integral to the development of significant new medicines including Viagra,

Revatio, Lipitor, and Somavert. • Ex Pfizer Global Research and Development, Ex Covance Clinical Services.

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IMUGENE SCIENTIFIC ADVISORY BOARDProf Pravin KaumayaOhio State University, U.S.A.

• Prof of Medicine Department of Obstetric Gynecology at Ohio State

University

• Research focus in tumour immunology, mechanisms of tumour cell-immune

cell interactions, and immune mechanisms

• Research focus on fields of vaccine with emphasis on peptide vaccines for

cancer

Prof Peter SchmidBarts Cancer Institute, Queen Mary University of London

• Medical Oncologist

• Expertise in breast and lung cancer, cancer immunotherapy and early drug

development

• Leads the Centre of Experimental Medicine at Barts Cancer Institute

Dr Neil Segal

Memorial Sloan Kettering Cancer Center, U.S.A.

• Medical Oncologist

• Expertise in GI, Colon, Pancreatic cancers

• Active clinical immuno-oncology researcher

• Clinical lead in several trials using PD-L1 inhibitors

Prof Tanios BekaiI Saab

Mayo Clinic, U.S.A.

• Professor of College of Medicine and Science

• Program Co-Leader, GI Cancer, Mayo Clinic Cancer Center

• Medical Director, Cancer Clinical Research Office (CCRO)

• Senior Associate Consultant, Mayo Clinic AZ

Prof. Ursula Wiedermann-Schmidt

Medical University of Vienna, Austria

• Co-inventor of HER-Vaxx

• Professor of Vaccinology at Medical University of Vienna

Prof. Josep Tabernero

Vall d’Hebron, Barcelona, Spain

• President of European Society for Medical Oncology (ESMO)

• President of the Medical Oncology Department at the Vall d’Hebron

• Director of the Vall d”Hebron Institute of Oncology (VHIO)

Dr Yelina Janjigian

Memorial Sloan Kettering Cancer Center, U.S.A.

• Medical Oncologist

• Expertise in esophageal and stomach (gastric) cancer

• Active in GI clinical trials testing combinations of Her-2 and checkpoint

inhibitor therapies

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Imugene develops vaccines to boost and direct the body’s immune system to specifically target and attack cancer cells.

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A BETTER WAY TO MAKE ANTIBODIES TO TREAT CANCER?

In a facility:

For example, Merck’s PD-1 inhibitor Keytruda

Using B-cells in your body

Teaching B-cells to make antibodies using peptide

antigens

VS

B-cells are cells in the

human body that

naturally produce

millions of antibodies

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HER-Vaxx MIMOTOPE: MECHANISM OF ACTION

B-Cell

B-cell Activation

HER-VaxxAntibody Secretion

Via helper T-cells

HER-Vaxx attacks the same target as the the world’s largest selling breast cancer drug Herceptin

Peptides “mimic” the

epitope

TumorCell

HER-2/neu3Peptides

HER-VaxxImmunotherapy

EPITOPE = Antibody

Binding Site

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CURRENT PHASE 1B/2, IN GASTRIC CANCER

2H, 2017 : Phase 1B

Patients Enrolled

2H, 2018: Phase 1B Recruitment Completed 1H, 2019: Commence Phase

2

1H, 2020: Interim Phase 2

Data Available

Phase 1b Lead-in Phase 2

• Open label

• ~Up to 18 patients in 3 cohorts of up to 6 pts per

cohort

• Combination with chemo/cisplatin

• Endpoints:

- Recommended Phase 2 Dose of HER-Vaxx

- Safety: any HER-Vaxx toxicity

- Immunogenicity (anti-HER-2 antibody titres)

• Open label

• ~70 patients from sites in Asia

• Combination with chemo

• Randomized

• Primary Endpoints:

- TBD PFS and/or OS

- (cont. on Ph1b results)

• Secondary endpoint:

- Immune response

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WORLDWIDE EXCLUSIVE LICENSE

Six patent families,

22 patents

Ongoing Her-2 clinical trial

(Phase 2)

IND ready PD-1 clinical trial

(Phase 1)

Six additional clinical candidates

Her-1, Her-2, Her-3, VEGF, IGF-1R CD28

Three year R&D contract with

access to Ohio translational labs

Access to experience and expertise with Prof. Pravin Kaumaya and team

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STRATEGIC AQUISITION

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11

80710.2217/FON.11.60 © 2011 Future Medicine Ltd ISSN 1479-6694

part of

Future O

nco

log

y

Future Oncol. (2011) 7(7), 807–810

The combination of different vaccine and thera-peutic strategies to target specific molecular path-ways that are dysregulated in tumors may create clinical breakthroughs for safe and efficacious cancer cures.

Today in the USA, over half a million can-cer patients will die and the financial costs are exorbitant, running to over US$200 billion, a burden that is shared by patients and society as a whole. Unmet need across the cancer market is high, with most therapies conferring low levels of specificity and high toxicity. Therefore, there is a great need for innovative technologies that address these discrepancies. A potentially power-ful line of defense against cancer that provides the opportunity to train the immune system to efficiently recognize and kill tumor cells would be highly significant in the field of personalized medicine. An ideal cancer treatment should be highly specific and have sufficient affinity to tar-get systemic tumors at multiple sites in the body while discriminating between normal and can-cerous cells. In this regard, antigen-specific can-cer immunotherapy and immune targeting of the tumor neovasculature represent two attractive strategies for cancer prevention and treatment.

Molecular-targeted therapies provide marginal benefits

Immunotherapy in the form of antibodies and cytokines has become a fixture in our arma-menterium of cancer treatments because of their potential as a safer and nontoxic alternative to present-day treatments. Many therapeutic modal-ities targeting receptor tyrosine kinases (RTKs) and downstream molecular pathways have been devised, and most outstanding among these are the EGF receptor (ErbB) and VEGF receptor (VEGFR) families of kinases [1–3]. Many agents include therapeutic antibodies to RTK ligands

or the receptors themselves and small-molecule inhibitors that target the intracellular kinase domains of RTKs [4–6].

“…antigen-specific cancer immunotherapy and immune targeting of the tumor neovasculature represent

two attractive strategies for cancer prevention and treatment.”

On the one hand, many of the blockbuster US FDA-approved monoclonal antibody (mAb) therapies targeting HER-2 (trastu-zumab [Herceptin®; Genentech, CA, USA]), EGF receptor (cetuximab [Erbitux®; Imclone, NJ, USA]) and VEGF (bevacizumab [Avastin®; Genentech]) have significant toxicities, includ-ing cardiac dysfunction and congestive heart failure [7–9], and many patients on these drugs demonstrate disease progression due to develop-ment of resistance. Unfortunately, mAbs also suffer from a number of limitations including the frequency of treatments, associated costs, lim-ited duration of action and undesired immuno-genicity. On the other hand, clinically available small-molecule tyrosine kinase inhibitors (TKIs) include lapatinib (dual targeting EGF receptor and HER-2), sunitinib (targeting VEGFR1, VEGFR2, PDGF receptor [PDGFR], KIT and FLT3) and sorafenib (targeting VEGFR2, VEGFR3, Raf, PDGFR, KIT and RET). TKIs including sunitinib and sorafenib can cause tox-icities in cancer patients. These inhibitors target multiple pathways including VEGFR, PDGFR and KIT. The toxicities associated with these TKIs may be due to the concomitant inhibition of several pathways. In addition, tumors even-tually become resistant to TKIs in almost all treated patients. Furthermore, these drugs are

Could precision-engineered peptide epitopes/vaccines be the key to a cancer cure?

“Combination cancer vaccines with peptide mimics have the potential to treat existing cancer

and prevent its recurrence.”

Pravin TP KaumayaThe Ohio State University, Department of Obstetrics & Gynecology, Suite 316 Medical Research Facility, 420 W. 12th Ave., Columbus, OH 43210, USA n kaumaya.1@osu.edu

Edito

rial

Keywords

n angiogenesis n cancer vaccine n HER-2 n peptide therapy n peptidomimetics n VEGF

For reprint orders, please contact: reprints@futuremedicine.com

11

PROF PRAVIN KAUMAYA & DR TANIOS BEKAII SAAB

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PRE-CLINICALCLINICAL DEVELOPMENTPROGRAM

DISCOVERY/PRE-CLINICAL ID OF CANDIDATE

HER-Vaxx (HER2)

B-Vaxx (HER2)

KEY-Vaxx (PD-1)

Her-2 & PD-1 Combo

PHASE 1

Combination:Her-1; Her-2; Her-3; IGF-1R

Her-1 (EGFR)

Her-3

IGF-1R

VEGF

Combination (numerous)

PD-1/PDL-1

PROGRAM

PHASE 2

CLINIC OR CLINIC READY

DISCOVERY PIPELINE

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IMUGENE PIPELINE

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ACQUIRED HER-2 VACCINE (B-Vaxx): ENCOURAGING PHASE 1 TRIAL RESULTS

-80%

-60%

-40%

-20%

0%

20%

40%

60%

80%

100%

120%

140%

160%

% m

axim

al c

hang

e in

SPD

from

bas

elin

e

dose level 1dose level 2dose level 3dose level 4

*

*

* *

*

†

* *

✭Best Response† PR* SDPD if not indicated

Phase Ib Immunotherapy Trial with a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide Vaccine emulsified in ISA720 and nor-MDP Adjuvant in Patients with Advanced Solid Tumors, Immunological Response and Clinical Outcome. Tanios Bekaii-Saab, Daniel H. Ahn,Christina Wu, Robert Wesolowski, Amir Mortazavi, Maryam Lustberg, Jeffrey Fowler, Bhuvaneswari Ramaswamy, Lai Wei, Jay Overholser and Pravin T.P.Kaumaya.Cancer Discovery 2018 manuscript in preparation

✭10 out of 24 patients had stable disease & 1 out of 24 patients had partial response; 1 patient had PFS at 40+ months

No toxicity observed

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Monoclonal antibody immunotherapies Keytruda® (Merck) and

Opdivo® (BMS) targeting PD-1 sold USD$3.8B and $4.9B, respectively, in 2017.

Whilst acknowledging the rapid rise in clinical trials involving PD-1 and their combination with other treatments*, a PD-1 B-cell vaccination approach

represents a paradigm shift in cancer immunotherapy.

.

In industry-recognized mouse cancer models (colon cancer), the PD-1 targeting B-cell

vaccine is more superior than the gold standard mouse

PD-1 monoclonal antibody (used in preclinical model testing for

Keytruda and Opdivo).

* Tang etal. Comprehensive analysis of the clinical immuno-oncology landscape, Annals of Oncology, 2017

The combination of the PD-1 vaccine with the acquired Phase II Her-2 vaccine

significantly inhibits tumor growth c/w mAb control in a Her-2+ model of

colon cancer.

14

WHY SELECT AND TARGET PD-1 FOR B-CELL VACCINATION?

v

PD-1/HER-2 VACCINE COMBINATION ACTIVE IN MODEL OF COLORECTAL CANCER WITH NO SIGNS OF TOXICITY

0%

39%

65%

90%

0% 20% 40% 60% 80% 100%

Control (PBS)

PD-1 mAb

PD-1 vaccine

PD-1 vaccine plus Her-2 vaccine

% Cancer growth inhibition in Colorectal cancer model§ All mice vaccinated over a period of 9 weeks showed no signs of scruffiness, lesions, and lethargy

§ Organs (spleen, liver, heart, lung, kidney, and tumor) from the Balb/c mice vaccinated with combination peptides (HER-2 and PD-1) were collected from mice and submitted for analysis

§ No significant lesions were noted in any of the organs submitted for histologic evaluation.

§ There were also no overt biochemical abnormalities noted.

Inhibition of cancer growth 16 days after infusion of cancer cells

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PD-1 “KEY-VAXX” VACCINE PHASE 1 DEVELOPMENT PATH 2018-2019

PD-1 candidate vaccine

Identified May, 2018

CMC manufacturing

2019: Commence Phase 1

OBD

Dose Finding

Signal Seeking

Cohort 3

*Safety *Immunogenecity

*Tumor PD

Expansions AssumptionProposed Adaptive Phase 1/2 PD-1 Vaccine Design

3 - 6

3 - 6Cohort 2

Cohort 1

3 - 6

Formalpre-clinical

Finalise regulatory IND submissions

Indication Expansion(12-20 patients)

Expansion

Indication Expansion(12-20 patients)

Proof of Concept

16

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FINANCIAL SUMMARY

Market Cap (31/Jul/18): $79.2M AUD, $58.9M USD

Ordinary Shares: 3.559 billion

12 month price range: 1.3 cents – 3.9 cents AUD

Avg daily volume:9.5M shares (April-July 2018)

Investment to Date:~$42.5M (public)~$ 5.5M (VC)

Cash & Equivalents:$25.8M(as at 31 July 2018)

No. of Shares % Capital

Private Portfolio Management 240,906,746 6.69%

Platinum Asset Management 165,986,536 4.61%

Dr. Nicholas Smith 86,000,000 2.39%

J P Morgan Nominees Australia Limited

79,957,741 2.22%

Paul HopperExecutive Chairman

75,678,722 2.10%

ASX:IMU

Top 5 shareholders (as at July 2018)

Options on issue (as at July 2018)

No. of options Exercise Price Expiry

Listed:(IMUOA)

242.5M $0.026 30/11/2020

Listed:(IMUOB)

248.3M $0.04 30/11/2021

Unlisted: 79.5M $0.024* 09/03/2020*

Total: 570.3M $0.03* 01/07/2020*

* Average

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Experienced Management & Board

• Meeting milestones

• Successful M&A activity

Imugene B-cell Vaccine Pipeline

Broadened and strengthened clinical

programs globally, including U.S. and

European centres

• HER-Vaxx milestones of Phase 1b

recruitment completed; Phase 2

activity commenced

• B-Vaxx Phase 2 ongoing

• KEY-Vaxx pre-clinical work started

Synergistic Technology Licensed from Ohio State University and The Mayo

Clinic

Full spectrum of indications and

targets to choose from, including

checkpoint inhibitors and

combination therapies

EXECUTIVE SUMMARY

18

v

19

• Experienced management & board: Meeting milestones and successful M&A activity

• Imugene B-cell vaccine pipeline: Broadened and strengthened clinical programs globally,

include U.S. and European centres

• HER-Vaxx milestones of Phase 1b recruitment completed; Phase 2 activity commenced

• B-Vaxx Phase 2 ongoing

• KEY-Vaxx pre-clinical work started

• Synergistic technology licensed from Ohio State University and The Mayo Clinic: Full

spectrum of indications and targets to choose from, including check point inhibitors and

combination therapies

EXECUTIVE SUMMARY

19

v

Leslie ChongChief Executive Officer &

Managing Director

+61 458 040 433leslie.chong@imugene.com