2. Forward-looking Statement
Certain statements made in this presentation are forward-looking
statements and are based on Immuron’s current expectations, estimates
and projections. Words such as “anticipates,” “expects,” “intends,” “plans,”
“believes,” “seeks,” “estimates,” “guidance” and similar expressions are
intended to identify forward-looking statements.
Although Immuron believes the forward-looking statements are based on
reasonable assumptions, they are subject to certain risks and uncertainties,
some of which are beyond Immuron’s control, including those risks or
uncertainties inherent in the process of both developing and
commercializing technology. As a result, actual results could materially differ
from those expressed or forecasted in the forward-looking statements.
The forward-looking statements made in this presentation relate only to
events as of the date on which the statements are made. Immuron will not
undertake any obligation to release publicly any revisions or updates to
these forward-looking statements to reflect events, circumstances or
unanticipated events occurring after the date of this presentation except as
required by law or by any appropriate regulatory authority.
5. THE GUT IMMUNE SYSTEM –
INNATE BUT NOT DORMANT
• The gut innate immune system bridges the lumen with
the systemic immune system
• The gut is the largest lymphoid organ in the body.
• Components: dendritic cells, epithelial cells, natural
killer cells, intraepithelial lymphocytes, M cel
• Differentiating antigenic signals against the high
“background noise” (“good” versus “bad” antigens)
• suppression of inflammation is the rule.
• Delivering the signals through the gut wall
• cytokines and chemokines, as well as innate and
adaptive components are involved
6. THE INFLAMMATORY BASIS OF DISEASE
• INFLAMMATION PLAYS A KEY ROLE IN THE
PATHOGENESIS OF MANY DISEASES
• Obesity and NASH are characterized by chronic
inflammation in peripheral tissues
• The "two hits hypothesis” puts inflammation as key to
formation of NASH.
• Immune mediators (systemic or adipose) influence
insulin activity leading to metabolic syndrome and
NASH.
• microbiome diversity and specific strains shown to be
associated with development of NASH.
7. PRESENTED TO THE GUT
INNATE IMMUNE
SYSTEM
TARGET ORGANS
•BOWEL
•PANCREAS
•ADIPOSE TISSUE
•LIVER
•BRAIN
WITHIN THE MESENTERIC LYMPH
NODES SPECIFIC CELLS ARE
PROMOTED TO CREATE A SYSTEMIC
RESPONSE
Based on: Ilan Y, Immunology Cell Biology, 2009
ORAL IMMUNE THERAPY
Ig & ADJUVANTS
8. ORAL IMMUNOTHERAPY
• ALTERING THE SYSTEMIC IMMUNE SYSTEM USING
INGESTIBLE COMPOUNDS.
• Mechanism:
• orally administered antigens, adjuvants, and
antibodies.
• targets the innate immune system of the gut,
including: NKT cells and dendritic cells.
• Signaling to the systemic immune system and
promoting regulatory T cells (Tregs) to suppress
inflammation at the site of disease.
• Stimuli “balances" level of systemic inflammation
through gut’s innate components
9. ORAL IMMUNOTHERAPY
• The gut immune system is continuously stimulated
• Stimuli include all antigens, adjuvants and
antibodies in the lumen
• The gut microbiome continuously deliver signals
based on diversity and types of bacteria
• Does NOT SUPPRESS the systemic immune system,
hence, limited side effects
• NO risk of severe infection or malignancy, and is
easily tolerated by patients.
11. Travelan® - ONE OF A KIND!
Infection: Bacteria attach
to gut wall and infect
Bacteria neutralized by
Travelan® antibodies
The only therapy that prevents
travelers’ diarrhea by 90%
12. http://www.travelan.com.au
`
• global market estimate: US$
600M - 1.2B
• All-natural product;
• clinically proven
• very high safety profile
• Available over-the-counter
• Strong brand loyalty
Travelan®
16. POTENTIAL APPLICATIONS:
i. Fatty Liver Disease & NASH
ii. Type 2 Diabetes and Pre Diabetes
iii. Clostridium Difficile
iv. Alcohol Induced Liver Damage & ASH
v. Other: Colitis, UPEC etc.
17. PIPELINE
IMM-124E
• POTENCY: The combination of Ig and Adjuvants is
more potent than either alone.
• Feasibility clinical study NASH and pre-DM
• IMM-124E independent evaluation - University of
Maryland
• NASH clinical study
• ASH NIH clinical study
18. IMM-124E
SYNERGISTIC POTENCY
DECREASED SERUM TRIGLYCERIDES
ANTI-LPS IG AND ADJUVANTS IN COLOSTRUM
A SYNERGISTIC EFFECT
0
100
200
300
400
500
600
700
800
900
ALTlevels(u/L)
*
DECREASED LIVER ENZYMES
An adjuvant effect in the gut
19. Group A:
Control
Group D:
Treated
Group B:
Naïve anti LPS
Group C:
Treated
IMM-124E
INFLAMMATION AND FIBROSIS
0
1
1.8
3.4
0
0.5
1
1.5
2
2.5
3
3.5
4
A B C D
*p<0.0009
^^ p<0.0003
Group A:
Control
Group D:
Treated
Group B: Naïve
anti LPS
Group C:
Treated
2.4
0.66
1.4 1.33
0
0.5
1
1.5
2
2.5
3
A B C D
*p<0.02
^^ p<0.01
Decreased portal inflammation
Mizrahi M. 2013, AASLD; Hepatology 751A
Improved Metavir fibrosis score
20. Mizrahi M. J Inflamm Res. 2012
Day 1 Day 30
INCREASED GLP1 AND ADIPONECTIN
INCREASED CD4+CD25+FOXP3+ TREGS
IMM-124E CLINICAL
GLP-1, ADIPONECTIN AND T-REG
21. IMM-124E CLINICAL
LIVER ENZYMES AND INSULIN RESISTANCE
Mizrahi M, J Inflamm Res. 2012;5:141-50
IMPROVED LIVER ENZYMES IMPROVED HBA1C, OGTT & HOMA
DM Clinical Study planned 2015 / 2016
22. IMM-124E
UNIVERSITY OF MARYLAND
IMMURON CONTRACTED THE UNIVERSITY OF
MARYLAND, VA TO CHARACTERIZE THE IMM-124E
• work is ongoing evaluating the following :
• Immunoglobulins content: Total IgG and IgA
• Immunoglobulins composition:
• Antibody Cross reactivity – showing reactivity
with other strains of gram negative bacteria
• Other possible components of IMM-124E:
cytokins, anti-inflammatory agents etc.
• Work to be competed and analyzed in Q4 2015
as part of the regulatory process.
23. 2 Phase II TRIALS - RECRUITING
NASH ASH
MULTI-CENTER, MULTI NATIONAL
DOUBLE BLINED 2-DOSE PLACEBO
CONTROLLED:
19 SITES RUNNING (AUS & USA) & 3
MORE COMING
RECRUITING 120 SUBJECTS
14 PATINTS ALREADY RANDOMIZED
AND COMING
MULTI-CENTER, USA BASED RUN BY
THE NASH CRN GROUP AND FUNDED
BY NIH
3 SITE RECRUITING
25% OF SUBJECTS ALREADY
RECRUITED
BASED ON PRELIMINARY CLINICAL
STUDY DATA
NIH funded, selected as 1 of 3 (from a
possible 27) treatments to be funded by the
NIH
24. Royal Melbourne
Hospital, VIC
Westmead Hospital,
Sydney, NSW
Princess Alexandra
Hospital, Brisbane, QLD
Nepean Hospital,
Sydney, NSW
Alfred Hospital
Melbourne, VIC
Box Hill Hospital
Melbourne, VIC
NASH Sites - Australia
25. NASH Sites – United States
Duke Liver Center,
Durham NC
U Florida, Gainesville, FL
Baylor St Luke’s
Houston, TX
U.Colorado, Denver, CO
Swedish MC Seattle, WA
Kansas City GE&H, MO
VCU, Richmond VA
UVA, Charlottesville VA
Bon Secours, Richmond/NN
Cleveland Clinic, OH
26. Murine studies performed at Monash University,
Australia:
• Prophylaxis - demonstrating effectiveness in 80%
• Treatment of C-diff prevented death in 100% of
cases
IMM-529 – TOXIN B DIRECTED
CLOSTRIDIUM DIFFICILE
TreatmentProphylaxis
27. • Decreased weight loss 17% versus 7.1%
• Ameliorated the colonic damage
• Increased IL10 serum levels
• Promoted regulatory T cells
IMM-124E
MURINE IMMUNE MEDIATED COLITIS MODEL
0.0
5.0
10.0
15.0
20.0
25.0
TNBS,
water
TNBS,
colostrum
cont
TNBS,
50µg anti
LPS
TNBS,
500µg
anti LPS
Weightloss(%)
*
*
IMM-124E Control
30. Immuron’s Platform Products Other Products
Natural product Synthetic product
High safety profile Side effects occur
Not a binary outcome.
If clinical end points not attained, there
is still a product that generates revenue
Binary outcome: clinical trial failure
means there is no product
Low Cost Antibodies typically very expensive to
make
Unique Platform Technology
Attractive risk-reward ratio – biotech upside with reduced risk profile
31. GETTING TO MARKET
MULTIPLE STRATEGIES MINIMIZING RISK
OR
OTC Consumers
TRADITIONAL MODEL
Pre-clinical
Phase I clinical
Phase II clinical
Phase III clinical
PRESCRIBED DRUG
IMMURON’S MINIMIZED RISK
OR
OTC Consumers
OR
Medical Food
32. Travelan®
32
Country Discussions Term Sheet Licensed Regulatory In Market
Canada
South Korea
Other Asian Countries
US (partnered)
United States (direct)
India
China
* Regulatory application preceding partnering engagement
No regulatory process
Immuron
AGM
Presentation
Nov 2015
Status in Nov 2013 Progress in 2014
33. NASH – OPPORTUNITY
• 25% of the US population has NAFLD
• 5% of develop NASH
• Estimated market 40B USD by 2025
• No treatment approved
• All major pharma are looking to get into
the game
• Most treatments do not capture the entire
disease population with limited efficacy
34. NASH - COMPETITIVE LANDSCAPE
Bile Acid Anti-fibrotic
Anti-Inflammatory + (
)
NASH is a Spectrum of conditions:
Room for many therapies
IMM-124E is safe and may be best in class
35. • C-diff infections due to
overuse of antibiotics
• Superbug
• Approx. US$3.2 billion
annually
• In collaboration with Monash
University
• Positive pre-clinical results to
date
US Hospitalisations Skyrocket
Annually due to C-diff.
85,700
Source:
Agency for Healthcare Research and Quality
346,800
IMM-529
CLOSTRIDIUM DIFFICILE
36. Indication Research Pre-clinical Phase I Phase II Phase III Market
Traveller’s
Diarrhea
NASH
(IMM-124E)
ASH
(IMM-124E)
Clostridium
difficile
infection
Other compounds and applications :
• Food Industry
• Pre- / Diabetes
The Immuron Pipeline
* Trial funded by NIH
37. Dr Roger Aston
Chairman
Daniel Pollock
Non-executive Director
Stephen Anastasiou
Non-executive Director
Dan Peres, MD
Senior VP of Innovation
Neta Tobis
Clinical Director
Dr. Yaron Ilan
Medical Officer
Nicky Konstantopolous
Development Manager
Reza Moussakhani
Manufacturing Quality Director
Roger has more than 20 years of experience in the pharmaceutical and biotech industries. He was the
Founding CEO Chief Executive Officer and a Director of Mayne Pharma Group Limited.
Daniel is an internationally experienced lawyer admitted in both Scotland and Australia, with significant
commercial expertise in new market entries into overseas markets, distribution agreements and corporate
start-ups.
Stephen has extensive experience in general management, marketing and strategic planning in the
healthcare industry, formerly with KPMG.
Dan had been leading Medical Device and Pharma companies in their clinical stage since 2008. a
Physician in origin has years of experience in management and medical development .
With over 7 years’ experience of international trial management for small to large pharma and medical
device companies as well as working within large CROs (PPD)
Dr. Yaron Ilan, MD, is a Director-Inpatient Medicine Department at Hadassah Medical Center. He holds
more than 50 patents and co-authored more than 240 articles.
Nicky is an experienced scientist with expertise in insulin action and metabolic conditions. She has held
postdoctoral roles with the Joslin Diabetes Centre at Harvard Medical School (Boston) and CSIRO
(Parkville, Melbourne).
A professional Operations manager with extensive experience in implementation of
project / quality and process improvements including with Hospira and
Sigma Pharmaceuticals.
Corporate Structure
The Board and Management