IMUGENE LIMITED — Capital/Financing Update 2017

Nov 22, 2017

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ASX:IMU

CAPITAL RAISING PRESENTATION

Leslie Chong | Chief Executive Officer November/2017

Not
for
release
to
US
wire
services
or
distribution
into
the
United
States

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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
ACN 009
179
551
( Company ).
In
preparing
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Company
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situation
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Shares
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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 v 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.

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ASX:IMU v CAPITAL RAISING

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CAPITAL RAISING SUMMARY

• Imugene is conducting a $8.7m capital raising to fully fund its HER-Vaxx Ph1b/2 program and provide working capital

• Offer price of A$0.018 per share represents a 21.7% discount to last close and a 20.9% discount to 15 day VWAP ( Offer Price )

Capital raising structure

• v

• • A$6.7m Placement to Sophisticated and Professional investors ( Placement )

• A$2.0m 1 for 21 Entitlement Offer to existing shareholders with registered addresses in Australia and New Zealand ( Entitlement Offer )

• Participants will also receive 1 free option for every 2 Placement or Entitlement Offer share subscribed for ( Option )

• Options will be listed on the ASX, with a 30 November 2020 expiry at strike price of A$0.026

• Shares issued under the Placement will not be eligible to participate in the Entitlement Offer.

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1) Assumes the Entitlement Offer is fully subscribed or subsequently underwritten

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USE OF FUNDS

Capital raising of A$8.7m will allow:

• Completion of HER-Vaxx Phase 1b/2 clinical trial

• Completion of at least 2 investigator sponsored studies (collaboration with institutional centers)

• Mimotope candidates Identified and development

• Mimotope IP secured

• Provide working capital

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TIMELINE

	PROGRAM	2H2017	1H2018	1H2018	1H2018	1H2018	1H2018	2H2018	2H2018	2H2018	2H2018	2H2018	2H2018	2H2018	2H2018	1H2019	1H2019	1H2019	1H2019	2H2019	2H2019	2H2019	2H2019	2H2019
	Interim El Initiate IST studies																	On-going data d IST				El
						Initiate IST studies
														El				aroun s						El
v HER-Vaxx Patients enrolled Early Patient Data Ph1b Patient Data Ph1b Data RP2D and Safety Data Start Ph2 Patients Enrolled In Ph2 ary Data On Ph2 Interim Data On Ph2 Ongoing data Of Ph2 ary efficacy data available Mimotope Announce mimotope target and candidate CMC Manufacturing Ongoing CMC Manufacturing Start formal pre-clinical work Ongoing pre-clinical work Announce any publication Provide results on Tox and Immunotox, safety and pharmacology Announce IND status Announce on various pre-clinical discovery results Start formal pre- clinical Announce candidate identity and release further pharmacology Provide results on Tox and Immunotox, safety and Start GMP manufacturing Study start up activities Announce IND status Start of study (CRO selection, design, Announce start of Phase 1a	HER-Vaxx Patients enrolled Early Patient Data Ph1b Patient Data Ph1b Data RP2D and Safety Data Start Ph2 Patients Enrolled In Ph2 ary Data On Ph2 Interim Data On Ph2 Ongoing data Of Ph2 ary efficacy data available			RP2D and Safety Data								Patients Enrolled		ary Data On			Interim Data On Ph2				Ongoing data Of Ph2			ary efficacy data available
										Start
										Ph2		In Ph2		Ph2
Arginine Modulators work results pharmacology timelines, etc.) 7

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INDICATIVE TIMETABLE

	Company in trading halt,	Tuesday, 21 November 2017
	Closing date for receipt of firm and irrevocable bids in Placement	Tuesday, 21 November 2017
v Offer announced, lodge Entitlement Offer Prospectus with ASX and company resumes trading Thursday, 23 November 2017 “Ex” date for Entitlement Offer Tuesday, 28 November 2017 Record date for Entitlement Offer Wednesday, 29 November 2017 Dispatch of Entitlement Offer booklet Monday, 4 December 2017 Allotment of Placement shares Wednesday, 6 December 2017 Closing date of Entitlement Offer Monday, 18 December 2017 Entitlement Offer shortfall notification Tuesday, 19 December 2017 Allotment of Entitlement Offer shares Wednesday, 22 December 2017 Timetable is indicative only and may be varied by the Company subject to the ASX Listing Rules	Offer announced, lodge Entitlement Offer Prospectus with ASX and company resumes trading	Thursday, 23 November 2017
	“Ex” date for Entitlement Offer	Tuesday, 28 November 2017
	Record date for Entitlement Offer	Wednesday, 29 November 2017
	Dispatch of Entitlement Offer booklet	Monday, 4 December 2017
	v Allotment of Placement shares	Wednesday, 6 December 2017
	Closing date of Entitlement Offer	Monday, 18 December 2017
	Entitlement Offer shortfall notification	Tuesday, 19 December 2017
	Allotment of Entitlement Offer shares	Wednesday, 22 December 2017

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ASX:IMU
v
COMPANY OVERVIEW
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WHAT DOES IMUGENE DO?

Imugene’s technology can induce a patient’s body to make its own specific v antibodies that target cancer.

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COMPANY OVERVIEW

• Experienced management & board

• Novel oncology platforms: Mimotopes: B cell peptide vaccines – IP
  protected
  to
  2036

• Lead mimotope: HER-Vaxx Phase 1b/2 mimotope study in Her2+ gastric cancer (large unmet medical need by current existing therapies)

• POC demonstrated in Phase 1 Her-2+ breast cancer study – safety & immunogenecity established

• Discovery Pipeline: Mimotope candidate selection and Arginine modulators in pre-clinical v

• development

• Numerous milestone announcements & valuation inflection points over next 12-18 months

• Summary of key risks

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A TEAM WITH TRACK RECORD IN DRUG DEVELOPMENT

Prof Ursula Wiedermann (Vienna, Austria) Chief Scientific Officer

Leslie Chong (Sydney, Australia)

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Chief Executive Officer

• Co-inventor of HER-Vaxx;

• Over 19 years of oncology experience in Phase I - III of clinical program development

• Professor of Vaccinology at Medical University of Vienna

• Leadership role involvement in 2 marketed oncology products

• Previously Senior Clinical Program Lead at Genentech, Inc., in San Francisco

Prof Christoph Zieliniski (Vienna, Austria) Head of Scientific Advisory Board

Dr Axel Hoos (Philadelphia, U.S.A.)

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Non-Executive Director

• Chairman of the Comprehensive Cancer Centre in Vienna

• Senior Vice President Oncology R&D at GlaxoSmithKline

• Chairman of the Centre for Eastern EU Organisation for Research and the Treatment of Cancer (CEEORTC)

• Previously Clinical Lead on Ipilimumab at Bristol-Myers Squibb

• Editor in Chief and President Nominee of European Society of Medical Oncology (ESMO)

• Co-Director of the think-tank Cancer Immunotherapy Consortium

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Dr Nick Ede (Melbourne, Australia) Chief Technology Officer

Paul Hopper (Sydney, Australia)

Executive Chairman

• Over 25 years peptide vaccine and drug development

• International & ASX biotech capital markets experience particularly in immuno-oncology & vaccines

• Former CEO Adistem, CEO Mimotopes

• Chairman of Viralytics, Founder & Director of Prescient, Founder of Imugene & Polynoma LLC, former Director pSivida, Somnomed & Fibrocell Science

• VP Chemistry Chiron (now Novartis), Research Fellow CRC Vaccine Technology

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A BETTER WAY TO MAKE ANTIBODIES TO TREAT CANCER?

IN A FACILITY

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For example, Roche’s Herceptin

USING B CELLS IN YOUR OWN BODY B Cells are cells in the human VS body that v naturally produce millions of antibodies Teaching B cells to make antibodies using peptide mimotopes

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NOVEL MIMOTOPE PEPTIDE PROGRAMS

• A mimotope is a small molecule, often a peptide, which mirrors the structure of an epitope, the specific target an antibody binds to

• Because of this property, the mimotope induces an antibody response similar to the one elicited by the epitope

• A mimotope causes your B cells to produce an antibodyv copy of the antibody you want to “mimic”

• Potential tool for selecting novel vaccine candidates against a variety of tumors

Peptides identified via computer aided programs: HER-Vaxx therapy MIMOTOPE ~~S~~ Peptides identified via mimotope technology

• Technology can be used to copy any approved antibody on the market today

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MIMOTOPE: PLATFORM TECHNOLOGY

SELECTION OF MIMOTOPES

A library of mimotopes can be interrogated with any monoclonal antibody to identify the mimotopes to which it binds

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CREATION OF A VACCINE IMMUNIZATION The selected mimotope or Immunization with the mimotopes can be used in peptide will lead to isolation or combination to the patients B-cells create a B-cell peptide producing copies of therapy with the the Ab you want to appropriate carrier system mimic and adjuvant.

v

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ENDOGENOUS AB PRODUCTION

Successful delivery will result in endogenous Ab production with associated immune memory

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The mimotope platform has the potential to be part of the next wave of immuno-oncology products. It makes multi-level therapies against a combination of targets achievable.

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ADVANTAGES OF MIMOTOPE INDUCED B-CELL BASED ANTIBODIES V. SYNTHETIC ANTIBODIES

	Issue	Natural B Cell Derived Antibodies	Monoclonal Antibodies
v Safety Stimulates the immune system to produce natural Abs, potentially safer, as demonstrated by HER-Vaxx Synthetic Ab, with side effects (including ventricular dysfunction, CHF, anaphylaxis, immune mediation) Efficacy Polyclonal Ab response reduces risk of resistance and potentially increases efficacy Monoclonal Ab - single shot Durability Antibodies continuously produced a lasting immune response to inhibit tumor recurrence Half life up to 12 days sometimes less Usability Potentially low numbers of vaccinations required per year Requires regular infusion Cost Low cost of production enables greater pricing flexibility facilitating combinations and opening up additional markets Expensive course of treatment >USD100K per year in the US	Safety	Stimulates the immune system to produce natural Abs, potentially safer, as demonstrated by HER-Vaxx	Synthetic Ab, with side effects (including ventricular dysfunction, CHF, anaphylaxis, immune mediation)
	Efficacy	Polyclonal Ab response reduces risk of resistance and potentially increases efficacy	Monoclonal Ab - single shot
	Durability	v Antibodies continuously produced a lasting immune response to inhibit tumor recurrence	Half life up to 12 days sometimes less
	Usability	Potentially low numbers of vaccinations required per year	Requires regular infusion
	Cost	Low cost of production enables greater pricing flexibility facilitating combinations and opening up additional markets	Expensive course of treatment >USD100K per year in the US

B-Cell Vaccines offer a unique opportunity to intervene at multiple points in the immune system and create immune memory which enhances durability of response.

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THE MONOCLONAL ANTIBODY (mAb) MARKET

• Multiple antibody therapies are approved to treat cancer, for example:

• Sales in 2016

• -­‐ Herceptin: >US$6.7 billion -­‐ Perjeta: >US$1.8 billion Rituxan: >US$7.3 billion

• -­‐ YERVOY®: >US$1.0 billion

• -­‐ OPDIVO®: >US$3.7 billion

• -­‐ KEYTRUDA: >US$1.4 billion

• -­‐

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Total monoclonal antibody market is currently at US$60 billion

• All of these antibodies are manufactured in a facility.

• Instead of infusing patients with antibodies synthesized in a factory, what if we can induce the patient’s own B-cells to make similar cancer-fighting antibodies using Imugene’s mimotope technology?

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HER-Vaxx MIMOTOPE: MECHANISM OF ACTION

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Peptides
“mimic” the
HER-Vaxx
epitope
Antibody Secretion
Tumor
Cell
3 B-cell HER-2/neu EPITOPE =
Peptides Activationv
Antibody
Via helper T- Binding Site
cells
B-Cell HER-Vaxx attacks the
same target as the
HER-Vaxx
the world’s largest
Immunotherapy
selling breast cancer
drug Herceptin
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ASX:IMU
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HER-Vaxx IS A PHASE 1B/2 STAGE MIMOTOPE PEPTIDE THERAPY BEING DEVELOPED FOR HER2+ GASTRIC CANCER

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PHASE 1 IN BREAST CANCER, COMPLETED AT MEDICAL UNIVERSITY OF VIENNA- SINGLE AGENT, NO CHEMO

*RESULTS

DESIGN

• •

• 10 patients Patients developed anti-HER-2 antibodies

• • Induction of cytokines (Th1 biased; IFNγ) All late stage breast cancer •

• patients Induction of memory T & B cells post

• • vaccination HER-2 +/++

• • Life expectancy > 4 months Reduction in T reg cells post vaccination, T v indicating strong vaccine response

• Conducted at Medical • Antibodies induced displayed potent anti-

• University of Vienna tumor activity

• Promising results - Patients were end stage and not primary target group

CLINICAL ENDPOINTS 1 Safety and Tolerability 2 Immunogenicity: antibodies and cellular responses

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• Wiedermann et. al., Breast Cancer Res Treat. 2010 Feb;119(3):673-83.

• Reviewed in peer publication

Safety, Efficacy, Durability, Usability, Cost

• Data Available in Science Booklet

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HER-VAXX INHIBITS HER-2 EXPRESSING CELLS

HER-Vaxx antibodies demonstrate anti-tumour effect by inhibiting validated HER-2+ gastric cell line

Combination with Herceptin shows significantly higher inhibition than Herceptin alone.

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Percentage of Inhibition
(mean + SEM)
Percentage of Inhibition on NCI-N87 gastric cancer
cell growth (c/w control) 50
50
SKBR3 518.A2
v 25
25
v
0 0
Control Herceptin HER-Vaxx sera HER-Vaxx sera plus
Herceptin
HER-Vaxx sera Herceptin® HER-Vaxx sera Herceptin® HER-Vaxx sera
+ Herceptin® + Herceptin®
HER-2+ gastric cancer cells -­‐25 HER-2+ breast cancer cells
Collaboration with US company 2017 BMC Cancer2017, Wiedermann Feb. 2017
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PHASE 1B/2 ENHANCED GASTRIC FORMULATION

Her-2/neu specific IgG kinetic, after last immunization

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1.60 3 w. after 3 doses vacc.
1.40
1.14 1.18 8 w. after 3 doses vacc.
1.20
0.94
1.00
0.89
0.84
0.80 0.81 16 w. after 3 doses
0.80 0.73
0.67 v vacc.
0.63 0.62
0.60
6 mo. after 3 doses
0.40 vacc.
0.20
0.05 0.04 0.04 Pre-immunization
0.00
P467-CRM+Montanide - 10µg P467-CRM+Montanide - 25µg P467-CRM+Montanide - 50µg
OD
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In the mouse model the new formulation sees circulating antibodies maintained for 6 months which equates to many years in humans.

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PHASE 1B/2, IN GASTRIC CANCER

Phase 1b lead-in

• 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)

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Phase 2

• Open label

• ~70 patients from sites in Asia

• Combination with chemo

• Randomized

• Primary Endpoints:

• -­‐ TBD PFS and/or OS

• v -­‐ (cont. on Ph1b results)

• Secondary endpoint:

• -­‐ Immune response

2H, 2017 : 2H, 2017: Early Patient 2H, 2017: Interim Ph1b Patients Enrolled Data Available Patient Data Available 23

1H, 2018: Final Ph1b Patient Data Available

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OUR INVESTIGATORS AND STUDY CENTERS

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CHINA YEE CHAO
THOMAS YAU
Taipei Veterans
Queen Mary Hospital
General Hospital
The University of
Hong Kong)
MYANMAR
TAIWAN
CHIA-JUI YEN
CHAIYUT
National Cheng
CHAROENTUM LAOS
Kung University
Maharaj Nakorn Hospital
Chiang Mai Hospital
JEDZADA
MANEECHAVAKAJORNv
SUEBPONG Rajavithi Hospital
TANASANVIMON THAILAND
King Chulalongkorn VIETNAM
Memorial
Hospital
CAMBODIA
ARUNEE PHILIPPINES
DECHAPHUNKUL WIROTE
Songklanagarind Hospital LAUSOONTORNSIRI
National Cancer Institute
of Thailand
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GASTRIC MARKET OPPORTUNITY

• Asia is the largest market for gastric cancer globally

• Gastric cancer is the second leading cause of cancer mortality in the world & its management, especially in advanced stages, has evolved relatively little

• ~1 million gastric cancer cases per year; ~19% patients with metastatic v

• gastric cancer are HER-2 positive

• Surgery, chemotherapy, radiation & Herceptin are the key treatments

• In many countries, particularly Asia, chemotherapy such as capecitibine

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Chemotherapy

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Monoclonal antibody

and 5-FU, is the standard of care, not Herceptin

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MARKET OPPORTUNITY

Indications	Gastric Cancer	Breast Cancer
	1 million cases of newly diagnosed cases,	1.67m cases of newly diagnosed cases;
Incidence	~190k are HER2+*	~418k are HER2+*
Prognosis	Poor. Median survival is 7-10 months	Varies in breast cancer type. 0.5m deaths per year
% of Patients HER2+ prevalence	~19%	~25%
Herceptin ®cost	v ~3,500 per dose every 3 weeks = $60,000 per year	~3,500 per dose every 1-2 weeks = 91,000-182,000
Herceptin ®benefits (in conjunction with surgery and chemotherapy)	2.7 months OS (overall survival) improvement than chemo alone	Improves OS by 33%-52%. Varies with breast cancer type and line of disease.

• 2017 Herceptin® sales total 6.7b in gastric and breast cancer

• *http://globocan.iarc.fr/old/FactSheets/

• Gastric cancer treatment market to grow at the rate of 14.6% annually to $4.4 billion by 2024; The AsiaPacific gastric cancer market is set to grow from its 2015 value of $1.3 billion to $2.7 billion by 2022

• HER-Vaxx could address not only relapsed patients, but patients in all stages of cancer progression.

• HER-Vaxx could have a significantly more convenient dosing regime over Herceptin®’s weekly and lengthy infusions.

*https://www.thepharmaletter.com/article/gastric-­‐cancer-­‐treatment-­‐market-­‐to-­‐grow-­‐at-­‐the-­‐rate-­‐of-­‐14-­‐6-­‐annually-­‐to-­‐4-­‐4-­‐billion-­‐by-­‐2024-­‐globaldata

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IMUGENE PIPELINE

HER-Vaxx (IMU-131)	HER-Vaxx (IMU-131)	Discovery	Pre-Clinical	Phase IB	Phase 2
Open Label Randomized, Controlled Study in Gastric Cancer	Chemotherapy + or - HER-Vaxx
*Combination Study in breast cancer	HER-Vaxx + Herceptin
*Herceptin Resistant/Failed Study	HER-Vaxx + Chemotherapy	~~v~~
*HER2+ in bladder and ovarian, NSCLC etc.	HER-Vaxx + Chemotherapy
= Initiated upon RP2D (IST)Investigator Sponsored or Collaboration study Christoph Zieliniski CECOG President ESMO president nominee engaged

*Christoph Zieliniski, CECOG President, ESMO president nominee, engaged

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ASX:IMU

MIMOTOPE B-CELL PEPTIDE THERAPY

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IMUGENE DISCOVERY PIPELINE

PROGRAM

MIMOTOPE IMMUNE ID OF PRE-IND WORK CLINICAL DEVELOPMENT IDENTIFICATION CHARACTERIZATION CANDIDATE

HER-Vaxx /Her2 Combo

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Mimotope #2 Mimotope #3

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Her2 / *Mimotope Combo

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Combo #3?

TBD

DISCOVERY ID OF CANDIDATE PRE-IND WORK Arginine Modulator

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FINANCIAL SUMMARY

		ASX:IMU		Top 5 shareholders(as at Sept.	Top 5 shareholders(as at Sept.	2017)
	Market Cap (20/Nov/17)	$54.5M AUD, $41.1M USD			No. of Shares	% Capital
	Ordinary Shares	2.370 billion		Platinum Asset Management	240,387,753	10.14%
	12 month price range	0.7 cents – 2.8 cents AUD		National Nominees Limited	97,002,685	4.09%
	Avg daily volume	2.7M shares (July-September 2017)		Webinvest Pty Ltd	85,000,000	3.59%
			v
	Investment to Date	~$15.2 m (public) ~$ 5.5 m (VC)		Paul Hopper Executive Chairman	71,696,875	3.03%
	Cash & Equivalents	$5.3M as of September 2017		Tisia Nominees	59,899,999	2.53%
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Summary of Key Risk

• IMU’s clinical trials may prove unsuccessful;

• IMU currently has no material revenues. IMU intends to raise additional funds

• from Australia and international strategic investors later in 2017, which will have a dilutive effect on existing shareholders;

• IMU is dependent on the performance of its partners and the retention of key

• consultants and personnel for its specialized business;

• IMU value may be impacted if its intellectual property is not able to be adequately v

• protected; and

• IMU may face competition from better resourced industry participants.

• IMU may not obtain an industry partner and/or the regulatory approvals (such as the granting of FDA approval) that it requires for sale of its products or the reimbursement approvals required for sales growth, or such approvals may be subject to delay

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EXECUTIVE SUMMARY

• Experienced management & board

• Novel oncology platforms: Mimotopes: B cell peptide vaccines – IP
  protected
  to
  2036

• Lead mimotope: HER-Vaxx Phase 1b/2 mimotope study in Her2+ gastric cancer (large unmet medical need by current existing therapies)

• POC demonstrated in Phase 1 Her-2+ breast cancer study – safety & immunogenecity established

• Discovery Pipeline: Mimotope candidate selection and Arginine modulators in pre-clinical v

• development

• Numerous milestone announcements & valuation inflection points over next 12-18 months

• Capital Raise

• Summary of key risks

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