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ACQUISITION OF BIOLIFE SCIENCE QLD LTD A Phase II Ready Cancer Immunotherapy Company (OCTOBER 2013) For personal use only

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Page 1: Ca r For personal use only · 2013-10-22 · The Product – how HER-Vaxx works! c. 10 R orks • n ®, s ds. • in ® → n® ”. • n ®os • t o s d s. • Rather than injecting

ACQUISITION OF BIOLIFE SCIENCE QLD LTD!A Phase II Ready Cancer Immunotherapy Company (OCTOBER 2013)

B cell peptide-based vaccines

Immunotherapy for HER2-Positive Gastric & Breast Cancer

February 2013 | Corporate Presentation

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Company Snapshot!

Key Statistics (post transaction)!

ASX Code! IMU!

Share Price! A$0.010!

Shares on issue! 928 million!

Unlisted options! 50 million!

Market Capitalisation! A$9.3 million!

Cash! A$3 million!

Board and Key Management!Mr Paul Hopper!Non-Executive Chairman!

Current MD Cappello Group Investment Bank!Former MD Australian Cancer Technology Ltd!Current Non-Exec Chairman Viralytics!

Dr Nicholas Ede!Executive Director!

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!

Dr. Axel Hoos!Non-Executive Director Elect!!

Currently Vice President Oncology R&D at GlaxoSmithKline. Previously Clinical Lead on Ipilumimab at Bristol-Myers Squibb, Co-Director of the influential think-tank Cancer Immnunotherapy Consortium, Imugene will be his only Board seat world-wide.!

Key Assets!

100% owner Biolife Vaccine Assets!

Fully granted patent family targeting several cancer immunotherapies, e.g. breast, gastric, pancreatic!

Primary value driver! Phase II ready cancer clinical trial!

100% owner Linguet Drug Delivery Assets!

Patent family covering buccal delivery systems and specific drug formulations !

Primary value driver!!

Consumer healthcare and OTC products!

Post Acquisition and Settlement !F

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BIOLIFE SCIENCES QLD LTD!Executive Summary & Investment Highlights

•  Biolife Science Qld Ltd is a biotechnology company which owns a novel oncology platform technology developed within the Medical University Vienna, Austria.

•  ~$10m has been spent to date

•  The lead candidate HER-Vaxx, is an FDA Phase II ready, B Cell gastric & breast cancer immunotherapy against the validated target, HER-2/neu

•  HER-2 Vaxx effectively turns the patients body into a “Herceptin® factory”!

•  Biolife is attractively priced and heavily discounted to Phase II peers

•  The strategy is to induce a polyclonal antibody response with similar anti-tumor properties as Herceptin® ... a blockbuster drug with sales of $6.4B pa

•  Strong Board, Scientific Advisory Board (SAB) and Management

•  Dr Axel Hoos (NED Elect) currently VP Oncology R&D at GSK

•  IMU will be only board seat worldwide

•  Founders and SAB from leading European institutions

•  Imugene is raising $2.5m to commence a robust FDA-approved Phase II trial in gastric cancer

•  Planned exit by way of trade sale or large pharma licensing transaction

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•  HER-2/neu belongs to the epidermal growth factor receptor family;

•  Tumor-associated antigen. Low/no antigen expression on normal tissue;

•  Overexpressed antigen on various tumors; e.g. gastric, breast, ovarian, & pancreatic cancers;

•  Associated with aggressively growing tumors with poor prognosis.!

THE TARGET – HER-2/neu!

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The Target: HER-2/neu

• HER-2/neu belongs to the epidermal growth factor receptors family.

• Tumor-associated antigen.

• Low/no expression (not common) on normal tissues.

• Overexpressed (common) on various tumors; e.g. gastric cancer, breast cancer, ovarian cancer, & pancreas cancer.

• Overexpressed both in primary tumors and metastases.

• Associated with aggressively growing tumors and a poor prognosis.

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The Target: HER-2/neu

• HER-2/neu belongs to the epidermal growth factor receptors family.

• Tumor-associated antigen.

• Low/no expression (not common) on normal tissues.

• Overexpressed (common) on various tumors; e.g. gastric cancer, breast cancer, ovarian cancer, & pancreas cancer.

• Overexpressed both in primary tumors and metastases.

• Associated with aggressively growing tumors and a poor prognosis.

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Page 5: Ca r For personal use only · 2013-10-22 · The Product – how HER-Vaxx works! c. 10 R orks • n ®, s ds. • in ® → n® ”. • n ®os • t o s d s. • Rather than injecting

The Product – how HER-Vaxx works!

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How Biolife’s HER-Vaxx works

• Rather than injecting a ready-made antibody like Herceptin®, HER-Vaxx is a vaccine that activatesa patient’s own immune system to produce its own HER2 antibodies.

• The strategy is to induce a polyclonal antibody response with similar anti-tumor properties as Herceptin®!

Effectively turns the patient’s body into a “Herceptin® factory”.

• Like Herceptin®, HER-Vaxx is directed against the HER-2 receptor. It consists of several 3-cell peptidesderived from the extracellular domain of HER-2.

• Biolife is using a B-cell vaccine. By vaccinating against a validated target (i.e. HER2 receptor) that is known toproduce a clinical response, Biolife’s technology platform is circumventing many of the obstacles encounteredby previous cancer vaccines.

•  Rather than injecting a ready-made antibody like Herceptin®, HER-Vaxx activates a patient’s own immune system to produce its own HER2 antibodies

•  The strategy is to induce a polyclonal antibody response with similar anti-tumor properties as

Herceptin® � Effectively turns the patient’s body into a “Herceptin® factory”!!•  Like Herceptin®, HER-Vaxx is directed against the HER-2 receptor. It consists of several B-cell

peptides derived from the extracellular domain of HER-2 (B-cell vaccine) •  No HLA (human leukocyte antigen) restriction! (advantage over T cell vaccine responses)

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Page 6: Ca r For personal use only · 2013-10-22 · The Product – how HER-Vaxx works! c. 10 R orks • n ®, s ds. • in ® → n® ”. • n ®os • t o s d s. • Rather than injecting

1 Herceptin® (Transtuzumab) drug insert, Genentech USA, Inc 2 Acuity Technology Management. Technical Expert’s Report , Biolife Science Qld Ltd, 2013 3 Fleck L (2006). "The costs of caring: Who pays? Who profits? Who panders?". Hastings Cent Rep 36 (3): 13–72 Ab = antibody

Potential Advantages of HER-Vaxx!

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Potential benefits of Her-VAXX

Herceptin® HER-Vaxx

Synthetic Ab, with side effects(including ventricular dysfunction, congestive heart failure, anaphylaxis)1

Invokes the body to produce it own natural Ab, therefore expected to be considerably safer

Monoclonal Ab Polyclonal Ab – expected to produce a more powerful anti-tumour effect2

Half life up to 12 days1Antibodies continuously produced- a lasting immune response to inhibit tumour recurrence

Requires regular infusion Potentially one vaccination required

Expansive course of treatment –US$70,000 per year in the US3

Low cost of production enables greater pricing flexibility and opens up additional markets that are currently uneconomic

1 Herceptin® (Transtuzumab) drug insert, Genentech USA, Inc2 Acuity Technology Management. Technical Expert’s Report , Biolife Science Ltd, 2013. 3 Fleck L (2006). "The costs of caring: Who pays? Who profits? Who panders?". Hastings Cent Rep 36 (3): 13–72F

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•  Both Humoral and Cellular immune responses detected ✔!•  Stable disease in 50% of patients, one patient in remission ✔!

Phase I Clinical Trial Completed with Positive Results!F

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•  Double blind, randomized, placebo-controlled study; •  Study to be conducted under an FDA Investigational New Drug Application (IND); •  Patients with relapsed metastatic gastric cancer overexpressing HER-2/neu; •  Testing HER-Vaxx in combination with standard chemotherapy (5-Fluorouracil and

Cisplatin); •  Orphan Drug Application (FDA) finalised and ready for submission; •  Small lead-in phase (n=10), to determine dosing; •  1:1 randomization: Arm one, n=34; Arm 2, n=34; •  First patient in: Q4/2014 (duration of manufacture of trial material and patient

recruitment ~ 12 months); •  Last patient out: Q4/2015.

Robust Phase II Clinical Design:!Big Pharma Focused!

Primary endpoint!•  Overall survival (OS) – 22 events required

Secondary endpoints!•  Progression-free survival, as assessed by immune-related response criteria •  Immune response

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Page 9: Ca r For personal use only · 2013-10-22 · The Product – how HER-Vaxx works! c. 10 R orks • n ®, s ds. • in ® → n® ”. • n ®os • t o s d s. • Rather than injecting

Two Major Cancer Opportunities!Market Opportunity

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Two Major Cancer Opportunities

Gastric Cancer

Occurrence 2nd most common cancer in men 3rd most common in women

Prognosis Poor. Median survival of only 7-10 months

% patients HER2+ 19%

Herceptin® useHerceptin® is not widely used for

gastric cancer (cost/benefit conundrum)

Herceptin® benefits (in conjunction with surgery and chemo)

Live about 2.7 months longer than patients who received chemo alone

• Biolife believes that HER-Vaxx will address not only relapsed patients, but patients in all settings.

• HER-Vaxx has a significantly more convenient dosing regime over Herceptin®’s three-weekly infusions for one year.

1 Herceptin.com

Breast Cancer

Most common cancer in women (1 in 8 risk)

Varies with breast cancer type. 0.5M deaths per year

25%

$50,000 - $100,000 paReimbursed in most countries

Varies with breast cancer type and primary treatment. Improves overall

survival by 33-52%1

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

•  HER-Vaxx has a potentially significantly more convenient dosing regime over Herceptin®’s three-weekly infusions for one year.

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Page 10: Ca r For personal use only · 2013-10-22 · The Product – how HER-Vaxx works! c. 10 R orks • n ®, s ds. • in ® → n® ”. • n ®os • t o s d s. • Rather than injecting

Comparable Cancer Drugs & Landscape!

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Comparable Cancer Drugs

Drug Disease Stage Method of action Company Comments Annual Sales

Herceptin®

(trastuzumab)HER2-positive

metastatic disease

mAb against HER2/NEU. ADCC

with NK cells involvement

Used as monotherapy or in combination with

chemotherapy

$6.4 B (2011)

PERJETA®

(pertuzumab)HER2-positive

metastatic disease

Recombinant humanized mAb

against HER2/NEU. Blocks ligand-

dependent heterodimerization

In combination with Herceptin and

Docetaxel

Recently approved

2012*

Taxotere®

(docetaxel)Locally advanced or metastatic disease Anti-mitotic Also used in ovarian,

prostate & NSCLC$3.1 B (2010)

Xeloda®

(capecitibine) Metastatic disease Prodrug inhibiting DNA synthesis Also used in colorectal $1.3 B

(2010)

Abraxane®

(paclitaxel) Metastatic disease Cytotoxic/ Antineoplastic

$390 M (2010)

Tykerb®

(lapatinib)Her2-positive

metastatic disease Kinase inhibitor In combination with Xeloda

$350 M(2010)

HER-Vaxx’s proposed method of action combines that of BOTH Herceptin® and PERJETA™ (see slide 27)

* Jeffries estimate peak sales of PERJETA™ of $8.5B per year

!  HER-Vaxx’s proposed method of action combines that of BOTH Herceptin® and Perjeta® !  Jeffries estimate peak sales of Perjeta® of $8.5B per year

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For illustrative purposes only. These are NOT forecasts.

Market penetration model for gastric cancer!

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Market Penetration model for Gastric Cancer

Incidence of new gastric cancer cases p.a. 1,000,000

Proportion that are HER-2 positive andeligible for HER-Vaxx (being 25%) 250,000

Market penetration 10%Patients treated with HER-Vaxx 25,000

Estimated cost of HER-Vaxx per year per patient $20,000

Estimated gross sales $500 MGross royalty to Biolife assuming 12% royalty $60 MRoyalty to founders at 20% $12 MNet receipts attributable to Biolife $48 M

MARKET PENETRATION10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

ROYA

LTY

RATE

8% $ 32 $ 64 $ 96 $ 128 $ 160 $ 192 $ 224 $ 256 $ 288 $ 320 9% $ 36 $ 72 $ 108 $ 144 $ 180 $ 216 $ 252 $ 288 $ 324 $ 360

10% $ 40 $ 80 $ 120 $ 160 $ 200 $ 240 $ 280 $ 320 $ 360 $ 400 11% $ 44 $ 88 $ 132 $ 176 $ 220 $ 264 $ 308 $ 352 $ 396 $ 440 12% $ 48 $ 96 $ 144 $ 192 $ 240 $ 288 $ 336 $ 384 $ 432 $ 480 13% $ 52 $ 104 $ 156 $ 208 $ 260 $ 312 $ 364 $ 416 $ 468 $ 520 14% $ 56 $ 112 $ 168 $ 224 $ 280 $ 336 $ 392 $ 448 $ 504 $ 560 15% $ 60 $ 120 $ 180 $ 240 $ 300 $ 360 $ 420 $ 480 $ 540 $ 600 16% $ 64 $ 128 $ 192 $ 256 $ 320 $ 384 $ 448 $ 512 $ 576 $ 640

For illustrative purposes only. These are NOT forecasts.

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Robust Intellectual Property – 100% owned!F

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Prestigious Scientific Advisory Board!

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Pipeline of Opportunities!

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Pipeline of Opportunities

HER-Vaxx,PPXQRWKHUDS\ againstHER2/neu + gastric cancer

HER-Vaxx,PPXQRWKHUDS\ againstHER2/neu + breast cancer

Option on antigen�mimotopes and LPPXQRWKHUDS\�against various cancers

Option on oral vaccination with tumor antigen mimotopes

Discovery Preclinical Phase I Phase II

I/II

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Priced well below Phase II ASX Peers!

As of 15 October 2013!Source: Bloomberg!F

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“Cancer immunotherapies turn corner in race to mega blockbuster market”

Fierce Biotech October 2013

Business Strategy - EXIT!F

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•  Unlike many immunotherapy attempts, HER-Vaxx is directed against a validated target;!•  HER-2 is also the target of Roche’s Herceptin® and Perjeta®, both $billion blockbuster

drugs; •  Successful Phase I results in metastatic breast cancer; excellent safety and toxicology

profile; •  Potentially significant advantages over Herceptin® and Perjeta®; •  Safety, more potent and efficacious, cheaper – opens new markets; •  Outstanding scientific pedigree; •  Manufacturing contract locked in; major risk in biologic development eliminated; •  Experienced Board, Scientific Advisory Board and Management:

•  Axel Hoos (NED Elect), currently VP Oncology R&D at GSK – his only Board seat worldwide;

•  Attractively priced and heavily discounted to Phase II peers.!

In addition:!•  Linguet™ provides a solution and a point of difference to nutraceutical and

pharmaceutical companies; •  Licensing of Linguet platform for vitamins and supplements by Q4 2013.!

Why Imugene?!F

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•  Successful granting of IND by FDA;

•  Manufacturing of trial material complete with full analytical and immunological data positive;

•  Dosing first patients in FDA approved trial (2015);

•  Launch and licensing of Consumer Healthcare range of vitamins and supplements (Linguet);

•  Licensing of prescription Calcidiol product for therapeutic Vitamin D Deficiency (Linguet).

Value Inflection Points over next 12 months!F

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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.

Forward looking statement!

Contact:!Dr Nick Ede!Executive Director!Imugene Limited!(ASX:IMU)! Suite 1, 1233 High St, Armadale VIC 3143 m: +61 (0) 400 642 254 e: [email protected] w: imugene.com!

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Why B-Cell Peptide Vaccines?

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

• Patient produces their own antibodies against the target.

• Polyclonal responses (superior to treatment with mAbs).

• 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.

• High chemical stability• Easy construction and manufacturing

• No oncogenic potential• Immunogenic – break of tumour tolerance

Long-Lasting ImmunityB-Cell Vaccines Offer

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Page 20: Ca r For personal use only · 2013-10-22 · The Product – how HER-Vaxx works! c. 10 R orks • n ®, s ds. • in ® → n® ”. • n ®os • t o s d s. • Rather than injecting

!

Imugene Limited ACN: 009 179 551

Suite 1, 1233 High Street, Armadale, VIC, 3142 Phone: 03 9824 5254 Fax: 03 9822 7735

!

ACQUISITION OF BIOLIFE SCIENCE QLD LTD INVESTOR Q&A

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!

Imugene Limited ACN: 009 179 551

Suite 1, 1233 High Street, Armadale, VIC, 3142 Phone: 03 9824 5254 Fax: 03 9822 7735

!

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Page 23: Ca r For personal use only · 2013-10-22 · The Product – how HER-Vaxx works! c. 10 R orks • n ®, s ds. • in ® → n® ”. • n ®os • t o s d s. • Rather than injecting

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Imugene Limited ACN: 009 179 551

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Page 24: Ca r For personal use only · 2013-10-22 · The Product – how HER-Vaxx works! c. 10 R orks • n ®, s ds. • in ® → n® ”. • n ®os • t o s d s. • Rather than injecting

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Imugene Limited ACN: 009 179 551

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!

Imugene Limited ACN: 009 179 551

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Page 26: Ca r For personal use only · 2013-10-22 · The Product – how HER-Vaxx works! c. 10 R orks • n ®, s ds. • in ® → n® ”. • n ®os • t o s d s. • Rather than injecting

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