IMUGENE LIMITED — Investor Presentation 2016

Jan 10, 2016

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ASX:IMU

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B Cell Vaccines for Immunotherapy

Leslie Chong Chief Operating Officer 11 January 2016

1

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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Why Imugene is Unique

T Cell vaccines have been exhaustively researched…

…but B Cell vaccines are an open frontier for immunotherapy

Imugene (ASX: IMU) leading in B Cell vaccines for immunotherapy

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Who is Imugene?

• Leading immunotherapy company, working on B Cell peptide vaccine technology developed at Medical University of Vienna, Austria

• Headquartered in Australia, publicly traded on Australian Securities Exchange (ASX:IMU)

• Lead product, HER-Vaxx, is a HER2 vaccine with Phase 1 in breast cancer completed

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• HER-Vaxx moves to Phase 1b/2 in HER2+ gastric cancer in 2016

• Exciting mimotope platform in development at Medical University of Vienna

• Seasoned management team led by Executive Chairman Paul Hopper

• Market capitalisation (1/5/2016) only US$16.1m (A$22.5m) One of the world’s best value immunotherapy stocks

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B Cell Peptide Vaccine Immunotherapy

• Imugene is one of the few biotech companies globally working on B Cell peptide vaccines for immunotherapy

• Our colleagues at Medical University of Vienna (MUW) have created a HER2 B Cell peptide vaccine, HER-Vaxx, capable of generating a robust anticancer polyclonal antibody response

• Imugene and MUW’s work on B Cell peptide vaccines is focused on discovering the potential to improve performance and cost effectiveness of monoclonal antibodies

• In the Era of Immuno-Oncology, B Cell peptide vaccines has a potential to play an important role

• We believe we have the management team to position B Cell peptide vaccines as a clinically relevant immunotherapy

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Why B Cell Vaccines?

• No HLA restriction

• Potential for higher affinity and specificity polyclonal antibodies than monoclonals, depending on epitope conformation

• Potential for additional and superior antitumor effects through targeting different biologically relevant regions for the cancer in question

• ADCC (Antibody dependent cell mediated cytotoxicity) and CDC (complement dependent cytotoxicity) as per monoclonals, but at much lower cost

• T Help can come from vaccine formulation

• Generation of immune memory

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B Cell
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Antibody
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• Potentially less toxicity

• Combining several B-cell epitopes into a single antigen is synergistic and results in a stronger immune response

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Why Our B Cell Peptide Vaccines?

2010 - First generation vaccine performed very well in the clinic

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Epitope discovery technologies

• •

• Allows most antigenic Target-specific epitopes to be antibodies with potent identified anti-tumor activity

• Reduction in Treg cells post-vaccination

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2016 - Third generation vaccine goes to clinic

• Single peptide

• CRM197 carrier system easier to make

• Significantly higher antibody titre in vivo

• Induction of cytokines (Th1 biased, IFN-γ production)

• Induction of memory T & B cells

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Why Imugene?

• Compelling science both for HER-Vaxx and mimotopes

• Leadership – Experienced management led by Executive Chairman Paul Hopper (Polynoma, Viralytics); the board owns 6%

• Validated target for first product – HER-Vaxx targets same receptor as Roche's ~$8bn Herceptin and Perjeta franchise

• Phase 1 completed – Anti-HER2 antibody responses, T helper cytokines, Treg cells suppressed, therapy safe

• Robust IP – Exclusivity for HER-Vaxx until at least 2030 on granted US and EU patents - further patent life extensions to 2036 and beyond underway

• News flow – Numerous milestone announcements and valuation inflection points over next 12-24 months

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ASX:IMU

B Cell Peptide Vaccines in the Era of Immuno-Oncology

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Imugene Operates in The Most Promising Area of Oncology Today…

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Imugene is an immunotherapy company developing B-cell based vaccines in the most promising area of oncology today – IMMUNO-ONCOLOGY

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The Immunotherapy Breakthroughs of the Last Five Years are Helping to Shape our Market Opportunity

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Generation 1 Generation 2 Generation 3
Multiple Therapies
(checkpoint modulator) under Development
MPDL3280A
Ipilimumab / CTLA-4 Pembrolizumab
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Generation 1 and 2
Sipuleucel-T Nivolumab predicted to generate
MEDI 4736
sales of $36bn by 2025
(Cell Therapy)
Blinotumumab
CAR-T
Approved Under Investigation
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*Citigroup research note

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ASX:IMU

HER-Vaxx – a Potential Breakthrough B Cell Peptide Vaccine

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HER-Vaxx Attacks the same Cancer Receptor the World’s Largest Cancer Franchise

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HER–Vaxx:
3 peptides P6
P4
P7
Binding site of
P4
HER-Vaxx: x3 Monoclonal
polyclonal P6 response
Binding site of
responses P7
Franchise sales annualising at
nearly $8bn growing 13%
HER-2
Receptor
Tumor cell
$USD Source: Roche H1 Report http://www.roche.com/hy15e.pdf p12
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HER-Vaxx is a Differentiated Product

• HER-Vaxx is a universal vaccine & can be used for all patient types irrespective of their “HLA haplotypes”, an issue which impacts T cell vaccines

• HER-Vaxx generates polyclonal responses that may be superior to treatment with a monoclonal antibody like Herceptin

• Toxicity of HER-Vaxx is negligible

• HER-Vaxx induces IFNγ production that can influence the tumour micro environment and suppresses T Reg cells which are enhanced in cancer patients & which assist tumor evasion mechanisms – thereby the efficacy of the HER-Vaxx might be enhanced

• Potential as an adjuvant therapy i.e., post surgery

• HER-Vaxx is active immunisation and induces immunological memory – Herceptin is passive immunisation, and its effectiveness depends upon frequent applications

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Phase 1a in Breast Cancer, Conducted at Medical University of Vienna, Demonstrated Immunogenicity*

• n=10

• Patients developed anti-HER-2 Abs

• All metastatic breast cancer patients

• HER-2 +/++

• Induction of cytokines (Th1 biased; IFNγ)

• Induction of memory T & B cells post vaccination

• Life expectancy > 4 months

• Conducted at Medical University of Vienna

• Reduction in T reg cells post vaccination, indicating strong vaccine response

• Antibodies induced displayed potent antitumor activity

• ❶ Safety and Tolerability

• ❷ Immunogenicity: antibodies/humoral and cellular responses

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

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

HER-Vaxx Has Been Considerably Optimised Since Phase 1a

Third Generation

First Generation

• (used in Phase 1a) was three separate B Cell epitopes delivered in virosomes

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Second Generation

• incorporated the three B Cell epitopes into a single 49-mer peptide

• 2x increase in antibody response in vivo compared to three single epitopes (extended patent life to 2030)

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• changed the delivery system from virosomes to CRM197 (which gave CD4 T-Help response), and added an adjuvant

• 10x increase in antibody response in vivo (potentially extends patent life to 2036)

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HER-Vaxx 3G Registers Markedly Increased
Antibody Titres
16,000
14,000
12,000
10,000
Very significant
increase seen after
8,000 x4 immunisations
6,000
4,000
2,000
-
Virosomes P467-30ug virosomes Adj P467-30ug CRM197
for HER-Vaxx Formulations
Immunisations
OD of Anti-P467 Antibody Titres In Mice After 4
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• Data adjusted for comparison; original data generated for P467-30ug CRM197 generated with 1/20th of the concentration of comparable virosome formulation. Adjustment may be subject to variation

NOTE: Actual antibody levels vary depending on number of immunisations, dose used and characteristics of antibodies under observation.

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Phase 1b/2, Starting 2016 Under an IND, in HER2+ Gastric Cancer

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• Open label

• Open label

• 15 patients, x3 groups of 5 patients

   - ~68 patients from sites in Asia
  
   - Combination with chemo
  

• Combination with chemo

• Endpoints:

• RP2D (Recommended Phase 2 Dose) of HER-Vaxx

• Safety: any HER-Vaxx toxicity

• Immunogenicity (anti-HER-2 antibody titres)

• Test booster schedule

  • (q 4 weeks or 8 weeks)

• Randomized

• Primary Endpoints:

• Overall Survival

• Progression-Free Survival

• Secondary endpoint:

• Immune response

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Phase 1b/2 Trial Design Gastric Cancer

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Phase 1b Phase 2
Her-Vaxx + Cisplatin + 5FU or
Cohort 3 5
R Capcitabine
A
Advanced N
Cohort 2 5 RP2D Adenocarcinoma OD 1:1 No crossover treatment interim PFS analysis Treat until Follow
of the Stomach M Continuous Immune response monitoring PD for OS
n=68 I
Z
Cohort 1 5 E SOC: Cisplatin + 5FU or
Capcitabine
Design Phase 1b/2
IND Submission Q1, 2016
Final Protocol Q1, 2016
N Phase 1b =15; Phase 2 = 68
# Sites 18-20
Enrollment Duration 36 months: Phase 1b=12 months; Phase 2 = 24 months
FPI Q2, 2016
End Points PFS, OS and Immune response
Vendors Central Lab
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ASX:IMU

Mimotopes – Delivering on the Promise of B Cell Peptide Vaccines

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With our mimotopes technology, we can reverseengineer monoclonal antibodies

• Our colleagues at Medical University of Vienna have developed cutting edge proprietary techniques to select peptides that would mimic monoclonal antibodies

• Imugene has acquired an option to develop mimotope vaccines with MUW.

• We believe mimotopes will be part of the next wave of the Immunooncology Revolution

• In conjunction with the MUW team we are now selecting novel vaccine candidates against a variety of cancer targets

• This greatly extends the Imugene’s oncology franchise and pipeline

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ASX:IMU

The Imugene value proposition

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Compelling science and commercial opportunity

HER-Vaxx

Mimotopes

• Strong antibody response

• T Regs down

• Tumor growth inhibition in vivo

• Induction of cytokines, inc. IFNγ

• Various proprietary technologies allows suitable B cell epitopes to be identified

• Monoclonal antibody market now >US$60bn pa

• Induction of memory T & B cells post vaccination

• IP life out to 2030 and beyond

• Existing HER2 franchise now US$8bn and growing

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Leadership – Extensive Drug Development Experience

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Leslie Chong – Chief Operating Officer • Appointment as COO in August 2015 • Previously Senior Clinical Program Lead at Genentech, Inc., in San Francisco

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– Prof Ursula Wiedermann Chief Scientific Officer • Co-inventor of technology • Prof of Vaccinology at Medical University of Vienna Dr Axel Hoos – Non-Executive Director • Currently Vice President Oncology R&D at GlaxoSmithKline • Previously Clinical Lead on Ipilumimab at Bristol-Myers Squibb • Co-Director of the think-tank Cancer Immunotherapy Consortium; Imugene is his only Board seat worldwide Dr Nick Ede – Head of Manufacturing • Former CTO Consegna, CEO Adistem Ltd, CEO Mimotopes P/L, COO EQiTX Ltd (ZingoTX & VacTX) • VP Chemistry Chiron (now Novartis), Research Fellow CRC Vaccine Technology Paul Hopper – Executive Chairman • International & ASX biotech capital markets experience particularly in immuno-oncology & vaccines • Head of Life Sciences Desk & Australia Desk at Los Angeles-based investment bank, Cappello Group • Director Prescient Therapeutics, Chairman Viralytics, former Director pSivida, Somnomed & Fibrocell Science 24

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Attractive Valuation
250
200
150
Median
US$66m
100
Imugene
50
US$13m
0
25
US$m market cap as at 5 Jan. 2016
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Our Stock Has Stabilised Since Mid-2015

• Company spent 2014 and 2015 preparing second and third generation HER-Vaxx

HOWEVER

• We are now going to the clinic in 2016

• We expect strong news flow

• There is potential for strong progress with our mimotopes program

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210
190
170
150
130
110
90
70
50
30
Imugene (USD) Nasdaq Biotechnology Index
23 October 2013 = = 100
Oct-13 Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15
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Strong News Flow

Report Phase 2 results 2H 2019 Recruit and run randomized controlled Phase 2 trial 2H 2017 Recruit for Phase 1b mimotope trial 1H 2017 US FDA IND allowed for mimotope 1H 2017 Report Phase 1b trial results late 1H 2017 IND enabling GLP, Safety, Tox results of mimotope 1H 2017 Report Progress and dose selection on Phase 1b 1H 2017

Preclinical in vivo, in vitro results for mimotope 2H 2016

Report on dose escalation progress and status of Ph1b 2H 2016 Four mimotopes Identified 1H, 2016 Recruit and run lead in Phase 1b trial 1H 2016 Announce preclinical immunologic results (Charles River) 1H 2016 Appoint Principal Investigator 1H 2016 US FDA IND allowed 1H 2016 Identification of 1[st] mimotope 1H 2016 Announce preclinical toxicology results (WIL) 2H 2015

mimotope Her-Vaxx

Her-Vaxx GMP clinical batch complete 2H 2015

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ASX:IMU

B Cell Vaccine Immunotherapy

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imugene.com @TeamImugene

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Our Stock

ASX:IMU, ISIN: AU000000IMU9

ASX:IMU, ISIN: AU000000IMU9
Market Cap (1/52016)	$22.5M AUD, $16.5M USD
Ordinary Shares	1.73 billion
12 month price range	0.8 cents – 1.7 cents AUD
Avg daily volume	2.28M shares (last three months)
Public Equity Invested to date	$9.00M
Cash & Equivalents	$4.3M (as at Sep ‘16, include 3.0M raise)

Options on issue (as at Jan. 2016) No of options Exercise Price Expiry	Substantial holders as at Jan. 2016 No. of Shares % Capital
Listed (IMUO) 371,177,356 $0.015 31-Mar-17	Otto Buttula 107,000,000 6.2
Unlisted 109,000,000 $0.0173 30-Oct-17 TOTAL 480,177,356 $0.0155 18-May-17	Tom Henderson 89,666,666 5.2
	Paul Hopper 71,196,875 4.1

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• Average

Thank you

Leslie Chong Chief Operating Officer leslie.chong@imugene.com +61 458 040 433

Paul Hopper Executive Chairman receptogen@earthlink.net +61 406 671 515

Stuart Roberts Head of Corporate Development sroberts@imugene.com +61 447 247 909

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ASX:IMU

Appendix – HER-Vaxx Phase 1 Results

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

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Study Design*

Patient inclusion criteria

Administration & Readout Schedule

• Metastatic breast cancer

• HER2 +, ++

• ER/PR pos.

• Life expectance > 4 mo

Primary endpoint

• Safety & Tolerability

Secondary endpoint

• Immunogenicity

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D0 D28 D56 D84
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Vaccination with 10μg Blood draw
of each peptide antigen
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• Specific antibodies

• Cellular responses

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

Patient Characteristics – Aged 55-84 *

Patient	ID Age	Metas. disease since	Prior chemotherapy	Current antihormonal therapy
1	55	Oct. 2006	no	Anastrozol
2	66	May 2004	yes (1 adj)	Fulvestrant
3	84	Mar. 1999	no	Anastrozol
4	79	Sept. 2003	no	Anastrozol
5	67	Apr. 2004	no	Fulvestrant
6	69	Sept. 2004	no	Anastrozol
7	60	Aug. 2002	yes (3 met)	Fulvestrant
8	76	Apr. 1999	no	Fulvestrant
9	63	Jun. 2006	yes (1 met)	Exemestan
10	70	Apr. 2008	No	Anastrozol

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

Safety and Tolerability - Few Grade 1 Local Reactions, None Systemic*

Patient	ID Local vaccination	reaction grade Systemic grade 3/4 toxicity
1	1	no
2	0	no
3	0	no
4	1	no
5	1	no
6	0	no
7	0	no
8	0	no
9	1	no
10	0	no

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

Phase 1 Secondary Endpoint – Immunologic Responses

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80 3
70
60 1 2 3 4
2
50
40 185 kDa
30 1
20
10
0 0
pre-post-pre-post-pre-post- kappa IgG lambda IgG
P4 P6 P7
Cellular responses show Th2 profile
peptide ab titer
H er-2/neu ab titer increase
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• 8/10 developed significant anti-peptide antibody levels

• In all but one the antibodies were also directed against Her-2/neu

• The majority also showed a 4-fold increase in influenza titres (HI)

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

Reduction in Regulatory T Cells*

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• Significantly higher number of CD4+Foxp3+ regulatory T cells in tumour patients than healthy controls

• Vaccination significantly reduced T reg cells in both groups

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CD4+CD25+
CD4+Foxp3+
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• Breast Cancer Res Treat. 2010 Feb;119(3):673-83.

Excellent Immunogenicity, even at low dose, and in Patients aged up to 84 years, with no Cardiotoxicity

• Strong immunogenicity in 8/10 patients in Phase 1 study with 10 μg of peptide antigen

• Good correlation with cellular responses (cytokines)

• Safe and well tolerated, in particular no cardiotoxicity

• Protective efficacy of peptides demonstrated in preclinical tumor model in mice showing delay of onset and reduced tumor growth

Antibody and cellular responses in human

	Pat. #	Peptide- specific ab	HER2- specific	Infl. HIT	IL-2, IFNγ, TNF	T reg
		P4, P6, P7	ab
	1	↑ ↑↑	↑	-	- - -	↓
	2	↑ ↑ ↑	↑	↑	↑ ↑ ↑	↓
	3 4 5	↑ ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↑	↑ (+/-) ↑ ↑	- ↑ ↑	↑ - - - ↑ ↑ ↑ ↑ ↑	↓ ↓ ↓
	6	- - -	-	-	↓ ↓ ↓	↓
	7	↑ ↑ ↑	↑	↑	- - -	↓
	8	↑ ↑ ↑	↑ (+/-)	↑	↑ ↑ -	↑
	9	↑ +/- +/-	↑	↑	↑ ↑ ↑	↓
	10	- - -	-	-	+/- ↓ +/-	↓

HER-Vaxx breast cancer vaccine – Phase 1 trial 10 μg group

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

Tumor Growth Inhibition in vivo *

• Prolonged time to disease progression

• Immunization of c-neu transgenic mice (recognized HER2 cancer model) with tetanus toxoid-conjugated peptides P4, P6 and P7

• Vaccinated animals show significant delay in tumor onset and reduced growth kinetics

• Co-administration of IL-12 further improves the vaccine performance

Time to disease progression

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Days after randomization
Preclinical study with tetanus toxoid–conjugated peptide antigens
Cumulative proportion tumor-free
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d 65 d 170 d 235

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

No toxicity, in particular no cardiotoxicity

• Repeat dose toxicity study with TTconjugated peptides in mice

• Repeat dose toxicity study with HER-Vaxx in rats

• Local tolerability & immunogenicity study with HER-Vaxx in rabbits

• In vitro toxicity study with purified serum from immunized animals on rat cardiomyocytes

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Rat cardiomyocytes
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In vitro toxicity study on rat cardiomyocytes

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

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ASX:IMU

B Cell Vaccine Immunotherapy

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Leslie Chong

Chief Operating Officer leslie.chong@imugene.com +61 458 040 433

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imugene.com @TeamImugene

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