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ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES 1 Investor Presentation January 2014 Chief Executive Officer - Amos Meltzer For personal use only

ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

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Page 1: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

ORAL IMMUNOTHERAPY

USING BOVINE ANTIBODIES1

Investor PresentationJanuary 2014

Chief Executive Officer - Amos Meltzer

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Page 2: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

Forward-looking Statement

Certain statements made in this presentation are forward-looking statements and are basedon Immuron’s current expectations, estimates and projections. Words such as "anticipates,""expects," "intends," "plans," "believes," "seeks," "estimates," "guidance" and similarexpressions are intended to identify forward-looking statements.

Although Immuron believes the forward-looking statements are based on reasonableassumptions, they are subject to certain risks and uncertainties, some of which are beyondImmuron’s control, including those risks or uncertainties inherent in the process of bothdeveloping and commercializing technology. As a result, actual results could materially differfrom those expressed or forecasted in the forward-looking statements.

The forward-looking statements made in this presentation relate only to events as of the dateon which the statements are made. Immuron will not undertake any obligation to releasepublicly any revisions or updates to these forward-looking statements to reflect events,circumstances or unanticipated events occurring after the date of this presentation except asrequired by law or by any appropriate regulatory authority.

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Page 3: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

Investment highlight

• Safe and proven technology platform

• Rich product pipeline

• Travelan® approved and already in market generating sales

– Revenues growing and set to accelerate.

• 2nd product: Fatty liver / NASH

– an expected off-label use $3.2B market by 2016 in the US alone with no current treatment

– Very positive Phase I/IIa results

– FDA granted IND for Phase IIB trials for NASH

– Red hot focus on companies developing NASH after Intercept Pharmaceuticals recently leapt from $1.5B to $8.5B on positive NASH trial.

• 3rd product: Preventative treatment for C. diff bowel infections.

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Page 4: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

4

Section 1Company Overview

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Page 5: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

Corporate Structure

Rank Name Units (m) % of Units

1. GRANDLODGE PTY LTD 101.6 9.8

2. MR PETER ANASTASIOU + MRS KRISTINE PATRICIA ANASTASIOU <ANASTASIOU SUPER FUND A/C> 66.7 6.4

3. CHIMAERA CAPITAL LIMITED 65.0 6.3

4. HADASIT MEDICAL RESEARCH SERVICES & DEVELOPMENT LTD 59.2 5.7

5. FIFTY-FIFTH LEPRECHAUN PTY LTD <THE ANDRIA A/C> 50. 0 4.8

6. CAPITAL CONCERNS PTY LIMITED <LOGUE FAMILY SUPER FUND A/C> 34.9 3.37

7. MR DAVID ANTHONY PLUSH + MRS ANN LOUISE PLUSH <PLUSH SUPER FUND A/C> 33.4 3.22

8. G & N LORD SUPERANNUATION PTY LTD <GNR SUPERANNUATION FUND A/C> 20.4 1.97

9. INSYNC INVESTMENTS PTY LTD <WEEKLEY SUPER FUND NO 1 A/C> 19.0 1.83

10. MR HAMISH SALMON + MRS BRIGETTE MCGUIRE <SALMON FAMILY SUPER FUND A/C> 16.0 1.55

ASX Code IMC

Shares on Issue 1,053,679,310

Current Share price 1.0 c

Top 20 holders 55.4%

New Cornerstone investors

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Page 6: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

Corporate StructureBoard and Management

• Chairman - Dr Roger AstonFounding CEO of Mayne Pharma Group; experience with FDA and EU product registration, clinical trials, global licensing agreements & fundraising

• Non-executive Director – Daniel PollockInternationally experienced lawyer with significant commercial expertise in new market entries into overseas markets, distribution agreements and corporate start-ups.

• Non-executive Director – Stephen AnastasiouExtensive experience in general management, marketing and strategic planning in the healthcare industry, formerly with KPMG.

• Chief Executive Officer – Amos MeltzerTechnology commercialisation specialist with over 18 years experience in a diverse range of life science and other businesses.

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Page 7: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

The PlatformPoints of Difference

7

Product Other products

� Natural product � Synthetic product

� Powerful systemic immuno-modulatoryeffect

� Immune modulation can be achieved

� Does not suppress immunity � Can suppress immunity

� Proven: no side effects or toxicity � Some side effects or toxicity

� Easily tolerated by patients � Not easily tolerated by patients

� Polyclonal Abs combat infectious diseases effectively

� Monoclonal Abs are strain specific

� Oral administration � Oral administration

� Rapid Development Cycle� Longer and substantially more costly

development

� HIC: multiple regulatory pathways, multiple revenue streams

� Ordinarily: one regulatory pathwayFor

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Page 8: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

The Pipeline

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Indication Research Pre-Clinical Phase I Phase II Phase III Market

Traveller’sDiarrhea

NASH (IMM-124E)

ASH (IMM-124E)

Clostridium difficile infection

Other Projects:

Related to Liver

Related to IMM-124E

And other indicationsFor

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Page 9: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

9

TRAVELAN Section 2

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Page 10: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

TRAVELANThe last 3 years

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• Unique: Prevents travellers’ diarrhoea

All other products are treatments and typically start to provide benefits only 48-72 hours after the onset of an attack

• All Natural

• Accessible: over-the-counter.

• It works: Clinically proven, >90% efficacy

Traveller’s diarrhoea market estimated between $600M and 1.2B globally

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Page 11: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

TRAVELANIn Market, the last 3 years

0

1,000

2,000

3,000

4,000

5,000

6,000

Jan-10

Feb-10

Mar-10

Apr-10

May-10

Jun-10

Jul-10

Aug-10

Sep-10

Oct-10

Nov-10

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Sep-11

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Dec-11

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Feb-12

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Apr-12

May-12

Jun-12

Jul-12

Aug-12

Sep-12

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Nov-12

Dec-12

Jan-13

Feb-13

Mar-13

TRAVELAN

License with TakedaTakeda shed its pharmacy sales force

License Termination

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Page 12: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

TRAVELAN Australia

Wh

ole

sale

rs

R e

t a I l e

r s

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R e

t a I l e

r s

Wh

ole

sale

rs

Previous arrangement:

Current arrangement (from July 2013):

Immuron is commanding substantially higher margin

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Page 13: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

TRAVELANGoing Forward

Approved

In Discussion

Various stages of regulatory process

`̀In Revenue

In Discussion

In Discussion

Licensed

Proceeding through regulatory process

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Page 14: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

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IMM-124E for NASHSection 3

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Page 15: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

NASHHow big is the opportunity?

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Market cap: $8.5B

January 9, 2014:Announces successful results in NASH clinical trials

What this mean for Immuron:

Scientifically• NASH is addressable

Commercially• There is a huge, unmet opportunity.• NASH on the radar.

Comparison:• Intercept’s drug increases bad

cholesterol, reduces good cholesterol

• Immuron’s drug has shown to do the opposite.

Immuron may still be best in class

Intercept Pharmaceuticals (NASDAQ: ICPT)$1.5B before more than quadrupling overnight on NASH trial results

Market cap: $1.5BFor

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Page 16: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

NASHThe Epidemic

Fatty liver: one of most common liver diseases in the industrialized world

Non-Alcoholic Steatohepatitis (NASH): the most severe form of liver injury in the spectrum of non-alcoholic fatty liver disease

Chronic Inflammatory Disease, associated with Obesity, Type II Diabetes (insulin resistance), Hyperlipidemia

1 in 5 NASH patients develop liver cirrhosis Leads to liver cancer

NASH – An Epidemic of

NCID : >25M AMERICANS WILL HAVE NASH BY 2025

THERE IS NO APPROVED DRUG

ESTIMATE: OFF-LABEL MARKET ~$2B

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Page 17: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

IMM-124E for NASHReady to go: Phase 2B trial

Based on existing technology:

- Mature manufacturing process

- High Safety profile

IMM-124E has been independently validated: selected as only 1 of 3 products to be studied for alcoholic steatohepatitis (ASH) under a fully funded NIH TREAT study

IND cleared by the FDA: Immuron set to commence clinical trials

Preparations under way

Investigators identified

NASH remains a very large unmet medical need of significant interest to the medical profession and the pharmaceutical industry

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Page 18: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

IMM-124E for NASHMechanism of Action

Oral Immunotherapy: An approach to treating autoimmune, infectious and inflammatory disease through the oral delivery of antibodies

Scientific support for Immuron’s approach continues to grow

Immuron has the right product at the right time

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Page 19: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

• Metabolic syndrome is a chronic inflammatory disorder associated with insulin resistance and hepatic steatosis.

• Anti LPS colostrum (Imm124-E) is a bovine colostrum raised against LPS from an E.coli extract.

• Imm124-E was shown to exert an immunomodulatory effect and to alleviate target organ damage in animal models.

• Aim: To determine the safety and efficacy of oral administration of anti LPS colostrum to patients with insulin resistance and NASH.

INTRODUCTION

METHODS• In an open-label trial, 10 subjects with biopsy

proven NASH and insulin resistance or diabetes type II were orally treated for 30 days with Imm124-E (600 mg a day).

• Subjects were monitored for serum levels of insulin, adiponectin, and GLP-1 and for the changes of expression in peripheral regulatory T cells (Tregs).

• Clinical effect was evaluated by: OGTT, liver

enzyme, and lipid profile. The comparison

was done between day 1 and day 30 for each

patient.

• Data analysis was carried out on responders.

Improvement in early insulin secretion (6/10 Pt. p=0.07)

Improvement in LDL levels (8/10 Pt.p=0.07)

Administration of Imm124-E improved hepatocellular liver

enzymes levels p<0.04.

Improvement in HBA1C levels (9/10 Pt.

p<0.001)

CONCLUSION• Oral administration of Imm124-E exerts an

immunomodulatory effect in subjects with insulin resistance or type 2 diabetes, hyperlipidemia and NASH.

• The anti-inflammatory effect and promotion of peripheral Tregs, were in some of the responders associated with alleviation of insulin resistance and NASH in these subjects.

Improvement in GLP1 secretion (6/10 Pt. p=0.07)

Improvement in cholesterol levels 9/10 Pt.

p<0.05)

RESULTS

0.0

20.0

40.0

60.0

80.0

100.0

Day 1 Day 30

AL

T

lev

els

(u

/L)

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

Day 1 Day 30

AS

T l

ev

els

(u

/L)

0.0

20.0

40.0

60.0

80.0

100.0

120.0

Day 1 Day 30

AP

le

ve

ls (

u/L

)

0.0

20.0

40.0

60.0

80.0

100.0

120.0

Day 1 Day 30

GG

T l

ev

els

(u

/L)

Administration of Imm122-E improved cholestatic liver enzymes levels (7/10 Pt. p<0.002)

0.0

2.0

4.0

6.0

8.0

10.0

Day 1 Day 30

Hb

A1

C

0.0

2.0

4.0

6.0

8.0

10.0

Day 1 Day 30

FP

G (

mm

ol/L

)

Improvement in FGT levels (6/10 Pt.

p<0.06)

0

500

1000

Day 1 Day 30Ins

uli

n l

ev

els

a

fte

r 3

0 m

in (

pg

/ml)

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

Day 1 Day 30C

hole

ste

rol le

vels

( µµ µµ

M/d

L)

0.0

2.0

4.0

6.0

8.0

Day 1 Day 30

Se

rum

LD

L (

µµ µµM

/dL

)

0

24

68

1012

14

Day 1 Day 30

Se

rum

GL

P-1

(pM

, X

103 )

Increased Adiponestin secretion (8/10 Pt.p=0.08)

0.0

1.0

2.0

3.0

4.0

5.0

6.0

7.0

8.0

9.0

Day 1 Day 30

ga

ted

ce

lls

(%

)

CD25 - PE

CD

4 -

FIT

C

-10210

010

210

310

410

5

-101

102

103

104

105

CD4

0.39%44.94%

5.66%49.01%

Day 1

Day 30

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Day 1 Day 30

ga

ted

ce

lls

(%

)

30Day 1Day

0.0

1.0

2.0

3.0

4.0

5.0

Day 1 Day 30

ga

ted

ce

lls

(%

)

1Day 30Day

DISCLOSURE0.0

10.0

20.0

30.0

40.0

50.0

60.0

Day 1 Day 30

ga

ted

ce

lls

(%

)

Increased N. of CD4+CD62+ cells (6/10 Pt.

p<0.002)

Increased N. of CD4+CD25+ cells (7/10 Pt. p<0.001)

Increased N. of CD4+CD25+FOXp3 cells (7/10 Pt. p<0.001)

Increased N. of CD4+CD25+HLA-DR cells (8/10 Pt.p<0.001)

* Medical Director of Immuron.

The study was supported by Immuron Ltd, Australia

0

2000

4000

6000

8000

10000

Day 1 Day 30Adiponectin (ng/m

l)

Clinically ProvenF

or p

erso

nal u

se o

nly

Page 20: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

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R&D PIPE LINESection 4

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Page 21: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

• Clostridium difficile (C.diff): a bacteria normally found in people’s intestines.

• Certain circumstances C.diff can multiply and its toxin causes illness such as

diarrhoea & severe inflammation of the bowel.

C.diff infection accounts for:

• considerable increases in length of hospital stays.

• more than US$3.2 billion in health care costs each

year in the United States.

IMM-529 for Clostridium difficile

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Page 22: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

• IMM-529 under collaboration with Monash University

• All data owned by Immuron

• IMM-529 demonstrated positive pre-clinical results:

• Encouraging preventative data

• Treatment effect currently being investigated

• Proprietary vaccine given to cows being improved

IMM-529 for Clostridium DifficileVery encouraging results to date

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Page 23: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

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LOOKING AHEADSection 5

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Page 24: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

2013: THE ACHIEVEMENTS

New Shareholders� April rights issue: high net worth investors who provide a lot of

support

Travelan: continuecommercialization

� Direct-to-wholesale model in Australia, increase revenues

� Regulatory approval in Canada

� Regulatory progress in licensed territories

� Discussions in various territories progressing

Fatty Liver / NASH

� Continue preparation for Phase IIb Clinical trial

� ASH trial cleared by FDA

� Industry (potential partner) interest

Clostridium difficile and other projects

� Very encouraging preventative result. Treatment studies ongoing.

� A number of promising applications, including for orphan conditions

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Page 25: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

LOOKING AHEADWhat we are seeking to achieve

Financial Strength � Improve balance sheet

Travelan: continuecommercialization

� More licenses

� More revenue

Fatty Liver / NASH

� Commence Phase IIb Clinical trial

� Partner

Progress R&D

� Progress to the clinic with another product

� A number of promising applications, including for orphan conditions

We continue to nurture and benefit from strong partnerships with our R&D collaborators and with our commercial partners.

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Page 26: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

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SUMMARYSection 6

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Page 27: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

THE OPPORTUNITY

Immuron presents a unique opportunity:

The near term future:

Addressing large unmet medical need in red hot area: NASH / fatty liver .

Positive Clinical results

Potential: Orders of magnitude greater than the value of the Travelan business.

Substantial support for this therapeutic from clinical results, key opinion leaders and the NIH.

The present:

Current market cap of ~$10M can be justified based on the company’s in-revenue Travelan business alone.

Revenues are growing and set to accelerate.

The infrastructure:

Experienced Management Team

Supportive shareholders

Immuron’s retains control of its production.

The rich pipe line:

Immuron’s technology supports a rich pipeline of products.

The time to market for Immuron’s products is accelerated on account of the high safety profile and the various regulatory options.

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Page 28: ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES · Investor Presentation January 2014 For personal use only Chief Executive Officer -Amos Meltzer. ... Extensive experience in general management,

THE OPPORTUNITY

Thank you

ContactAmos Meltzer – Chief Executive OfficerPh: 0437 587 680

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