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CELLMID LIMITED ACN 111 304 119 ASX I CDY Suite 1802, Level 18, 15 Castlereagh Street Street, Sydney NSW 2000 AUSTRALIA TELEPHONE +61 2 9221 6830 FACSIMILE +61 2 9221 8535 WEB www.cellmid.com.au ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT "BROKERS MEETS BIOTECH” SYDNEY, Wednesday, 18 September 2013: Cellmid Limited (ASX: CDY) provides the following shareholder update, which will be presented at the "Brokers Meet Biotech" luncheon in Perth, on 19th September, by CEO and Managing Director Maria Halasz. End Contact: Maria Halasz, CEO T +612 9221 6830 Cellmid Limited (ASX: CDY) Cellmid is an Australian biotechnology company developing innovative novel therapies and diagnostic tests for inflammatory diseases and cancer. Cellmid holds the largest and most comprehensive portfolio of intellectual property related to midkine and midkine antagonists globally. The Company’s most advanced development programs involve using its anti- midkine antibodies for the treatment of cancer and inflammatory diseases. In addition, Cellmid is commercialising midkine as a biomarker for cancer diagnosis. Elevated midkine concentration in the blood and other body fluids is strongly indicative of cancer. For further information please see www.cellmid.com.au. Midkine (MK) Midkine is a multifunctional growth factor that is highly expressed during embryonic development. Midkine modulates many important biological interactions such as cell growth, cell migration and cellular adherence. These functions are relevant to cancer, inflammation, autoimmunity, ischemia, nerve growth/repair and wound healing. Midkine is barely detectable in healthy adults and only occurs as a consequence of the pathogenesis of a number of different disorders. Midkine expression is often evident very early in disease onset, even before any apparent physical symptoms. Accordingly, midkine is an important early marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only present in a disease context, targeting midkine does not harm normal healthy tissues. For personal use only

ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

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Page 1: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

CELLMID LIMITED ACN 111 304 119 ASX I CDY Suite 1802, Level 18, 15 Castlereagh Street Street, Sydney NSW 2000 AUSTRALIA TELEPHONE +61 2 9221 6830 FACSIMILE +61 2 9221 8535 WEB www.cellmid.com.au

ASX ANNOUNCEMENT

CELLMID CEO PRESENTS AT "BROKERS MEETS BIOTECH”

SYDNEY, Wednesday, 18 September 2013: Cellmid Limited (ASX: CDY) provides the following shareholder update, which will be presented at the "Brokers Meet Biotech" luncheon in Perth, on 19th September, by CEO and Managing Director Maria Halasz. End

Contact: Maria Halasz, CEO T +612 9221 6830 Cellmid Limited (ASX: CDY) Cellmid is an Australian biotechnology company developing innovative novel therapies and diagnostic tests for inflammatory diseases and cancer. Cellmid holds the largest and most comprehensive portfolio of intellectual property related to midkine and midkine antagonists globally. The Company’s most advanced development programs involve using its anti-midkine antibodies for the treatment of cancer and inflammatory diseases. In addition, Cellmid is commercialising midkine as a biomarker for cancer diagnosis. Elevated midkine concentration in the blood and other body fluids is strongly indicative of cancer. For further information please see www.cellmid.com.au. Midkine (MK) Midkine is a multifunctional growth factor that is highly expressed during embryonic development. Midkine modulates many important biological interactions such as cell growth, cell migration and cellular adherence. These functions are relevant to cancer, inflammation, autoimmunity, ischemia, nerve growth/repair and wound healing. Midkine is barely detectable in healthy adults and only occurs as a consequence of the pathogenesis of a number of different disorders. Midkine expression is often evident very early in disease onset, even before any apparent physical symptoms. Accordingly, midkine is an important early marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only present in a disease context, targeting midkine does not harm normal healthy tissues.

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Page 2: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

Maria Halasz CEO

CELLMID LIMITEDHIGH GROWTH ASSETS AND SOLID REVENUE GROWTH

September 2013

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Page 3: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

This presentation contains forward-looking statements that aresubject to risks and uncertainties. Such statements involve knownand unknown risks that may cause the actual results, performanceor achievements of Cellmid to be materially different from thestatements in this presentation.

Actual results could differ materially depending on factors such asthe availability of resources, the results of clinical studies, thetiming and effects of regulatory actions, the strength of competitionand the effectiveness of the Company's patent protection.

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Page 4: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

KEY STATISTICS• Share price $0.028• Market cap $17.6M• Shares on issue 650M• Options 300M• Cash (30 June 2013) $2M• Top 20: 35%• 6 month turnover 675M shares ($23.6M)• Cash burn $250K/m. (before revenue)

Cellmid Limited (CDY:ASX)

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BOARD• Dr David King (Chairman)• Maria Halasz (CEO and MD)• Graeme Kaufman (NED)• Martin Rogers (NED)

MANAGEMENT• Maria Halasz (CEO and MD)• Darren Jones (Head of Products)• Koichiro Koike (Business Development)• Emma Chen (Business Development AU)

6 MONTH SHARE PRICE PERFORMANCE

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Page 5: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

3. Cancer diagnostic products: on market with regular royalty from 2014 

1. Cellmid’s business, assets and key milestones

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Agenda

2. Cancer drugs ready for clinical development

4. Consumer health: strong revenue growth in 2014

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Page 6: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

1. CELLMID’S BUSINESS, ASSETS AND KEY MILESTONES

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Business structure

Companion biomarker for cancer program

Midkine Cancer Therapeutics

Broad Intellectual property

Cellmid

FGF‐5 inhibitor OTC hair growth products sold in AU and Japan, 

to be  launched globally in 2014

Consumer health

CxBladder launched in USA by licensee in 2013

2nd license with Quest     lung cancer 

Pipeline hair growth product in 

development

3rd license  with Fujikura expected in  1Q2014

Revenue growth in 2014Validated science 

Clinic  ready antibody drugs in multiple cancers 

in 2014 

Midkine Cancer Diagnostics

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Page 8: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

Cellmid owns 78 patents (20 patent families)

Antibodies to treat cancer Composition of matter/method of treatment  (MK antibodies)  Production of anti‐MK mAbs using Mdk‐/‐mice Early diagnosis of cancer

Over 250 peer reviewed publications on MK by Cellmid inventors

Large inventory– 130 highly characterised monoclonal antibodies– >4g of purified rhMK protein ($5M market value)– MK knockout mouse (Mdk‐/‐) model

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Midkine (MK) assets – broad portfolio 

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Milestone timetable 4Q2013

1Q2014

2Q2014

3Q2014

4Q2014

1Q2015

2Q2015

3Q2015

4Q2015

CancerTherapeutic

IND enabling studies (start and finish)

Pre‐IND meeting

Phase 1/2a

Cancer Diagnostics

Fujikura license

CxBladder royalty

LungDx (Quest) 

Consumer health

Chinese, EU and Indian distributor

US distributor

Key milestones

The above is subject to a number of internal and external factors including the availability of resources, the results of studies, the timing and effects of regulatory actions, the strength of competition and the effectiveness of the Company's patent protection.

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2. MIDKINE CANCER THERAPEUTICS READY FOR 

CLINICAL DEVELOPMENT IN 2014

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Discovered in 1988, subject of >600 scientific papers since

The number of publications on midkine continue to grow

Year

Midkin e

p ap ers

0

300

600

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Page 12: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

• Growth factor prominent in embryogenesis, but barely detectable in healthy adults 

• In adults, midkine expression occurs in two settings:

1. Inflammation 2. Malignancy 

• >90% amino acid identity between mammalian species

Allows strong validation in animal models

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Highly basic 13kD protein (121 aa) Two domains (N and C) 

Midkine is a dominant driver of cancer 

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MK-positive IHCGastric adenocarcinoma

Zhao et al Mol Med Report 2012

MK negative (n=33)

MK positive (n=74)

100

80

60

40

20

0

0 20 40 60 80

MK is highly prognostic of poor survival in gastric cancer

% s

urvi

val

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• Midkine antibody inhibits primary tumour growth and slows metastasis in osteosarcoma

• Intra‐muscular xenograft (143B cell line)

• IP injection 24h post xenograft, then every 5 days to 42 days (dose 4mg/kg)

Sueyoshi et al Can Lett 2011

Tum

or g

row

th(c

alf c

ircum

fere

nce,

mm

)

Time (weeks)

Anti-MK mAb

Tumor growth Lung metastases

n=5

n=5

Midkine antibody slows tumor growth

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Page 15: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

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Planned Phase 1/2a clinical study

• 4Q2013: Commence IND enabling studies• 3Q 2014: Pre‐IND meeting• 4Q2014: Commence open label study in multiple solid tumours 

(colorectal, lung, gastric)• 3Q2015: Expected early efficacy information• 4Q2015: Expected completion of phase 1/2a

• End stage patients with prior chemotherapy • 12 patients in 4 groups of 3 each • Log 3 dose escalating (4 doses, 1 per week)F

or p

erso

nal u

se o

nly

Page 16: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

3. CANCER DIAGNOSTICS ON  MARKET WITH REGULAR 

ROYALTIES FROM LATE 2014

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Page 17: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

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Blood

Tissue

Urine

Breast

Prostate

Ovaria

nCe

rvical

Uterin

eLung

 (NSC)

Lung

 (SC)

Lung

 (brain m

ets)

Neu

roblastoma

Glioblastoma

Med

ulloblastoma

Prim

ativene

urectode

rmal

Men

ingino

ma

Neu

rofribromatosistype

 IGastric

GI strom

alBladde

rCo

lorectal

Duod

enal

Oral SCC

Osoph

agealSCC

Hepatocellular

Bile Duct 

Pancreatic

Thyroid

Osteo

sarcom

aRe

nal

CLL

Blank space: not tested

MK is overexpressed in at least 26 different tumour types – license opportunities

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Page 18: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

PRECLINICAL CLINICAL  MARKETCxBladder for bladder cancer 

(Pacific Edge) 

MK as an early cancer marker (Japan) Fujikura

Lung cancer diagnostic(Quest)

MK metastatic colorectal diagnostic 

MK as a colorectal screening tool

MK as a marker in glioblastoma

Revenue generating, expect royalties from 2H2014

Revenue generating, expect milestone and royalties post 2014

Collaboration with Abcodia

Phase 2 MK as companion marker

Collaboration with  John Hunter  Hospital

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Diagnostic pipeline delivering revenue 

Revenue generating, expect royalties from 2015

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4. CONSUMER HEALTH: STRONG REVENUE GROWTH 

IN c2014

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First clinically validated topical hair growth product in 25 years

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• 21% increase in hair growth rate*• 35% reduction in hair loss*• 12% increase in growing follicles*• 74%  found the treatment beneficial 

for hair growth*

*Double blinded placebo controlled clinical study

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Inhibits FGF‐5, a protein responsible for hair loss 

Clinical study results

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evolis

June 2012 • Launched commercial proof of concept in Australia (website, media, trade)

Dec 2012 • More than 700 pharmacies signed up• Positive market response and solid early 

revenues

May 2013 • Acquired global rights with establishedJapanese distribution

• Acquired import permits to China

Australian launch confirmed market potential

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Page 23: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

• Chinese import permits for Jo‐Ju and Lexilisbrands

• Second largest hair growth market globally• Imported cosmetic products attract a premium 

• Cosmetics market is not price sensitive

Chinese import permits in place 

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Page 24: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

Revenue generating consumer health division with strong growth from emerging markets in 2014 

High value cancer therapeutic product pipeline going into phase 1/2a studies in multiple cancer indications 

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High value assets underpinned by revenue growth

Summary

Revenue generating diagnostics division with multiple licenses and regular royalty expected from late 2014 

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Page 25: ASX ANNOUNCEMENT CELLMID CEO PRESENTS AT BROKERS … · 18/09/2013  · marker for diagnosing cancers and autoimmune diseases. Finally, because midkine is only ... Cancer drugs ready

Thank youwww.cellmid.com.au

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@mariahalasz

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