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ORAL IMMUNOTHERAPY
USING BOVINE ANTIBODIES1
Investor PresentationJanuary 2014
Chief Executive Officer - Amos Meltzer
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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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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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Section 1Company Overview
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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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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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The PlatformPoints of Difference
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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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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
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TRAVELAN Section 2
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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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TRAVELANIn Market, the last 3 years
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TRAVELAN
License with TakedaTakeda shed its pharmacy sales force
License Termination
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TRAVELAN Australia
Wh
ole
sale
rs
R e
t a I l e
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R e
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Wh
ole
sale
rs
Previous arrangement:
Current arrangement (from July 2013):
Immuron is commanding substantially higher margin
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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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IMM-124E for NASHSection 3
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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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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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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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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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• 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
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100.0
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AL
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lev
els
(u
/L)
0.0
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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
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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
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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
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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
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R&D PIPE LINESection 4
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• 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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• 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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LOOKING AHEADSection 5
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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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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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SUMMARYSection 6
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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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THE OPPORTUNITY
Thank you
ContactAmos Meltzer – Chief Executive OfficerPh: 0437 587 680
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