IMUGENE LIMITED — AGM Information 2015

Oct 14, 2015

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ASX: IMU

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Corporate Presentation AGM 2015

1

IMU is in the Most Prospective Area of Oncology Today

Imugene is an immunotherapy company developing B-cell based vaccines for HER-2 positive cancers, in the most promising area of oncology today – IMMUNOONCOLOGY

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2

Investment Highlights

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Compelling Science
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Phase 1 Completed
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Commercially
Validated Target
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News Flow
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Robust IP
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Leadership
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• B-cell peptide cancer immunotherapy that induces antibody responses targeting HER-2 over expressing tumors + major new initiative into mimotopes

• Anti- HER-2 antibody responses, T helper cytokines, T reg cells suppressed, therapy safe

• Targeting same receptor as Roche's $6.4 bn breast cancer drug Herceptin

• Numerous milestone announcements & valuation inflection points over next 12-24 months

• IP with exclusivity until 2030, granted in all major jurisdictions. Further patent life extensions under way

• Experienced management & board – Board & management own 13%

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3

Company History

• Technology identified in 2012 by Axel Hoos

• Start-up company incorporated in late 2012, as Biolife Science Ltd

• Early stage funding secured 2013 from private investors in Australia & US

• Manufacturing, clinical and regulatory initiatives began in 2013

• Public listing on ASX in December 2013 via reverse merger into listed shell, Imugene Ltd with $3.0m raised

• Axel Hoos joins the Board – his only Board worldwide

• 2014 – manufacturing, clinical & regulatory development continues

• Dec 2014 - $3.0m raised

• Oct 2015 - $3.0m raised

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4

Imugene At A Glance (ASX:IMU)

• Developing B-cell based immunotherapy/vaccines known as HERVaxx, for HER-2 positive cancers plus major new initiative into mimotopes

• Phase 1 trial completed in patients with HER-2+/++ breast cancer

• Phase 1b/2 gastric cancer trial to begin early 2016

• Technology originates from Medical University of Vienna, one of Europe’s leading cancer institutes

• Market capitalisation (Oct 2015):

AUD17.0m (includes Sept raise)

• Share price (Sept 20 2015):

AUD0.10¢

• Average daily trade:

• 1.1m shares

• Shares outstanding:

• 1.73B

AUD$1.96m AUD$3.0m

• Cash & equivalents (Jun 30 2015):

• • Cash raised Sept 2015:

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5

Leadership – Extensive Drug Development Experience

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Leslie Chong – Chief Operating Officer

• Previously Senior Clinical Program Lead at Genentech, Inc., in San Francisco, widely regarded as one of the world’s most successful biotech companies with a significant oncology franchise including the best-selling breast cancer drug, Herceptin. • Appointment as COO in August 2015

Prof Ursula Weidermann – Chief Scientific Officer • Co-inventor of technology • Prof of Vaccinology at Medical University of Vienna

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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

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6

What is HER-Vaxx Therapy?

• HER-Vaxx is a B-cell vaccine designed to stimulate a patient’s own immune system to produce antibodies to repeatedly attack the cancer

• Stimulates a patient’s B cells to produce polyclonal antibody responses that target cells with overexpressing HER-2 receptors on their surface

• –

• Targets HER-2 positive cancer about 20% of patients with gastric cancer are “HER-2 positive” i.e., they have the HER-2 receptor on their cancer cells

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P6
P4
Epitopes Epitopes
Add Adjuvant
Identified Fused
P7
HER-2 Receptor Three Peptides HER-Vaxx Therapy
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7

WHY B-CELL PEPTIDE VACCINES?

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• Anti-tumor activity of antibodies induced by B cell epitopes

• Patient produces their own antibodies against the target

• Polyclonal responses (superior to treatment with monoclonal antibodies)

• No HLA restriction! (advantage over T cell responses)

• Induction of T cell responses and cytokine production via effective carrier system

• Multi-epitope approach means broad antigen recognition

• Identification via computer aided algorithms or mimotope technology

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What is HER-2? A Clinically & Commercially Validated Cancer Target

• HER-2 is a “hair-like” receptor found on the surface of many gastric & breast cancer cells (20-30%)

• –

• HER-Vaxx HER-2 if attack Her-2 the targets you

• cancer cell will die

• Too much HER-2 (over expression) in breast cancer is associated with:

• High chance that the tumour grows quickly and spreads

HER-2 Receptor

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• Greater probability of local & systemic recurrence

• Resistance to treatment

• –

• HER-Vaxx targets HER-2 if HER-2 is successfully targeted, the cancer will stop growing and die

• HER-2 is a & validated cancer clinically commercially

• target with Roche's Herceptin being the largest selling drug in the world for HER-2 positive breast cancer

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9

HER-Vaxx Attacks the Same Cancer Receptor as 3[rd] Largest Cancer Drug Worldwide

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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
$6.4bn worldwide sales
HER-2
Receptor
Tumor cell
$USD
http://www.medscape.com/viewarticle/826649
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10

HER-Vaxx: Mechanism of Action – How it Works

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Her-2 receptors Her-2 receptors
P6 3 Peptides
P4 Tumor
P7 HER-Vaxx Cell
Antibody Secretion
Via helper T-cells
HER-2/neu
B-cell
Activation Anti-Her-2 antibodies
produced
HER-Vaxx B-Cell Anti-Her-2 antibodies
Immunotherapy produced
11
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Clinical Status: Phase 1 Breast Trial Completed

• n=10 Safety and

• • Tolerability All metastatic breast cancer patients ❷ Immunogenicity:

• • antibodies/humoral HER-2 +/++ and cellular

• • Life expectancy > responses

• 4 months

• Conducted at Medical University of Vienna

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12

Clinical Status: Phase 1 Breast Trial Completed

Wiedermann et al., Breast Cancer Res Treat (2010) 119 :673 - 683

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• Patients developed anti-HER-2 antibodies

• Induction of cytokines (Th1 biased; IFNγ)

• Induction of memory T & B cells post vaccination

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

• Antibodies induced displayed potent anti-tumor activity

• Results were even more promising given

• patients were in the end stage of disease and not the primary target group

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13

Phase 1b/2 Trial Design Gastric Cancer

Combined Phase 1b/2 clinical trial under IND

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CRO appointed
Phase 1b lead-in Phase 2 Trial
• Open label • ~68 patients from Eastern
• US IND Europe (2 arms by 34)
•
Combination with chemo
• 18 patients, x3 groups of
6 patients • Efficacy, safety & immune
• response
Combination with chemo
•
Randomised
•
Endpoints:
– •
Dose of HER-Vaxx to use in Endpoints:
–
Phase 2 part of study Overall survival
– –
Safety: any HER-Vaxx toxicity Progression-free survival
–
Immunogenicity (anti-HER-2
•
Secondary endpoint:
antibody titers)
–
– Test booster schedule Immune response
(q 4 weeks or 8 weeks)
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14

Investment Highlights

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Compelling Science
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Phase 1 Completed
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Commercially
Validated Target
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News Flow
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Robust IP
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Leadership
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• B-cell peptide cancer immunotherapy that induces antibody responses targeting HER-2 over expressing tumors + major new initiative into mimotopes

• Anti- HER-2 antibody responses, T helper cytokines, T reg cells suppressed, therapy safe

• Targeting same receptor as Roche's $6.4 bn breast cancer drug Herceptin

• Numerous milestone announcements & valuation inflection points over next 12-24 months

• IP with exclusivity until 2030, granted in all major jurisdictions. Further patent life extensions under way

• Experienced management & board – Board & management own 13%

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15