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IMUGENE LIMITED Investor Presentation 2018

Jul 26, 2018

65124_rns_2018-07-26_b64488be-49bb-4bc5-b3fa-819ddbcb8c8f.pdf

Investor Presentation

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ASX:IMU

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HARNESSING B-CELLS FOR CANCER IMMUNOTHERAPY: A Paradigm Shift in Play Nicholas Ede, PhD Chief Technology Officer Bioshares Biotech Summit July 27 / 2018

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Imugene Limited (ASX:IMU)

Level 3,

62 Lygon Street Carlton VIC 3053

Dr. Nick Ede Chief Technology Officer

m: +61 (0) 400 642 254 e: [email protected] w: imugene.com

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.

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Imugene develops vaccine s 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?

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In a facility: Using B-cells in your body
VS
B-cells are cells in
the human body
that naturally
produce millions of
antibodies
Teaching B-cells to make antibodies using peptide
For example, Merck’s PD-1 inhibitor Keytruda
antigens
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MONITORING THE COMPETITION: DIFFERENTIATION IN A CROWDED MARKET

Constant monitoring of competitive landscape

Constant monitoring of Imugene position – SWOT analysis Synergistic technology acquisition from Ohio State University and The Mayo Clinic

Turn threats into opportunities / weaknesses into strengths

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STRATEGIC ACQUISITION

Ohio State University and Mayo Clinic B-cell peptide vaccine portfolio

  • ➤ Opportunity to create the pre-eminent, dominant position globally in B-cell peptide vaccines and therapeutics. A catalyst for value creation.

  • ➤ Professor Kaumaya’s work in the area of check-point inhibitors and tumor-associated antigens such as Her-2, is highly complementary to Imugene’s existing platform and portfolio.

  • Six patent families including composition of matter and method of use patents covering PD-1, Her-1, Her-2, Her-3, VEGF, IGF-1R, CD28 peptide vaccines and therapeutics.

  • • Commercially attractive upfront payment; royalty rate in low single digit royalty on sales; exclusive, world-wide and sub-licensable until expiry of the last patent.

  • ➤ Broadens and accelerates key Imugene Research and Clinical programs

  • PD-1 and HER2 + PD-1 combination programs accelerate by 24+ months

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OSU

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||||||
|---|---|---|---|---|
|WORLDWIDE, EXCLUSIVE|
|LICENSE|
|Six additional|Three year|
|Ongoing Her-|
|Six patent|IND ready PD-|2 clinical|clinical candidates|R&D contract|
|families,|1 clinical trial|Her-1, Her-2, Her-|with access to|
|trial|
|3, VEGF, IGF-1R|Ohio|
|22 patents|(Phase 1)|
|(Phase 2)|CD28|translational labs|
|Access to experience and expertise with Prof. Pravin|
|Kaumaya and team|
|7|

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

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.

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

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).

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.

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

  • ➤ 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.

% Cancer growth inhibition in Colorectal cancer model

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PD-1 vac cine plus Her-2 vac cine 90%
PD-1 vac cine 65%
PD-1 mAb 39%
Control (PBS) 0%
0% 20% 40% 60% 80% 100%
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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

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Finalise
2019:
PD-1 Formal regulatory IND
CMC Commence
candidate vaccine pre-clinical submissions
manufacturing
Phase 1
Identified May,
2018
Proposed Adaptive Phase 1/2
Expansions Assumption
PD-1 Vaccine Design
Cohort 3 3 - 6 OBD Indication
Expansion
Dose Finding
(12-20 patients)
Proof of
Signal Seeking
Cohort 2 3 - 6 Expansion Concept
Safety
Immunogenecity
Indication Expansion
Tumor PD
(12-20 patients)
Cohort 1 3 - 6
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IMMUNO-ONCOLOGY COMBINATIONS DRIVING VALUE

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  • ➤ Combining drugs for better I/O outcomes is driving value creation presently

  • ➤ Big Pharma are looking for novel combinations or “elusive blends” that:

  • Combine without increasing toxicity

  • Combine with minimal cost increase

  • Combine for better response rates and efficacy

  • ➤ Imugene’s cancer vaccines potentially tick all three boxes

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COMBINATION EXAMPLE

July 2018, FDA approves Opdivo The FDA approval of plus Yervoy combination for a combination Opdivo certain subset of and Yervoy provides Unfortunately, more a novel therapeutic patients with significant toxicity is metastatic option with a higher noted with the Although early in colorectal cancer response rate than combination, and development, that from diligence is needed Imugene’s PD-1 and monotherapy to monitor these Her-2 cancer vaccines immunotherapy, BUT immune-mediated potentially provide side effects efficacy and response rate with minimal toxicity

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PROFESSOR PRAVIN KAUMAYA & DR. TANIOS BEKAII SAAB

For reprint orders, please contact: [email protected]

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

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  • Combination cancer vaccines with peptide

mimics have the potential to treat existing cancer and prevent its recurrence.

Pravin TP Kaumaya

The Ohio State University, Department of Obstetrics & Gynecology, Suite 316 Medical Research Facility, 420 W. 12th Ave., Columbus, OH 43210, USA n [email protected]

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A TEAM WITH TRACK RECORD IN DRUG DEVELOPMENT

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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

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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

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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 BoDof the Sabin Vaccine Institute

  • Co-Chair of the Cancer Immunotherapy Consortium Think-Tank

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Dr Anthony Good (Sydney, Australia) Vice President of Clinical 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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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

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Mr. Charles Walker (Brisbane, Australia) Non-Executive Director

  • Experienced listed biotech CEO and CFO (ASX;ACL)

  • 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

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IMUGENE SCIENTIFIC ADVISORY BOARD

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Professor Peter Schmid (Barts Cancer Inst., London)

Chair of Cancer Medicine, Queen Mary Hospital London

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

  • Leads the Centre of Experimental Medicine at Barts Cancer Institute

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Prof Ursula Wiedermann (Vienna, Austria) Chief Scientific Officer

  • Co-inventor of HER-Vaxx

  • Professor of Vaccinology at Medical University of Vienna

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Dr Yelina Janjigian (MSKCC, 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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Dr Neil Segal (MSKCC, 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

Our competition is cancer, and in that fight, we’re collaborating with an outstanding team of medical researchers and oncologists

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EXECUTIVE SUMMARY

Imugene B-cell Vaccine Pipeline

Broadened and strengthened clinical programs globally, brings the Imugene platform and technology into US and European focused clinical trials

Synergistic Technology Acquisition from Ohio State University and The Mayo Clinic

Full spectrum of indications and targets to choose from, including check point inhibitors and combination therapies. Accelerates and advances Imugene PD-1 vaccine program by 24 months

Experienced Management & Board

Meeting milestones and successful M&A activity

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