Immuron presented an overview of the company, highlighting its OTC Travelan product, clinical pipeline including projects in NASH and C. difficile, and growth opportunities. The company is developing oral treatments for fatty liver disease and C. difficile using its proprietary anti-LPS antibody technology and has clinical trials ongoing. Immuron also markets the Travelan OTC product internationally and is working to expand its distribution. Near-term catalysts include progress in its NASH and C. difficile programs as well as a potential NASDAQ listing.
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 regulatoryauthority.
2
3. Immuron Limited
Company Overview
• Proven Platform – IP protected; Wide therapeutic possibilities
• In-Market OTC Product – Generating growing revenues with large
worldwide distribution upside
• Strong Pipeline – Two Phase II clinical trials with leading
competitive profiles in multi-billion market (Fatty liver disease
(NASH/ASH)
• Unique Safety Profile – No significant side effects; GRAS rated
• Market Cap Comparables for NASDAQ Companies Is Over
US$100M – One phase two
• Large ValuationUpside– Company currently valued at ~AUS$35M
3
4. 4
Causing:
- Impaired gut epithelial integrity
- Increased gut permeability
- Increased LPS serum levels
NASH – Pathogenesis
Unique Properties
Gut flora
imbalance
Overgrowth of intestinal bacteria
incl. gram-negative bacteria
Drives:
- Increased BT from lumen into liver through
portal vein (70% of blood flow to liver)
- Increased hepatic / systemic inflammatory
response (e.g., TNF)
- Induction of systemic inflammation by
innate immune cells in the gut
- Increased concentration of immunoglobulin
(mainly IgG)
- Strong anti-LPS properties, Cross reactive
- Immuno-active adjuvants that promote
regulatory T-Cells; suppress systemic inflammation
- Not absorbed in the blood
- Immune modulation without immune suppression
Prevents
bacteria spread:
Binds and
neutralizes wide
range of LPS
Allows
lumen to
rebuild
integrity
Decreasing BT /
LPS levels
resulting in
decreased liver
inflammation
Decreases liver inflammation - Improves liver function
promotes regulatory T cells
systemically that suppress
inflammation at site
Alter the function
of innate immune
cells in the gut
Obesity is
associated with
a chronic
inflammatory
state
IMM-124E – MOA
1
2
Decrease systemic and local inflammation
Liver damage contributing to progression of steatosis
then NASH then onto fibrosis and eventually cirrhosis
Systemic inflammation: Inflammatory cells and cytokines
secreted systemically
IMM-124E
Compelling MOA in NASH
5. 5
Immuron Limited
Investment Highlights
Significant and
Growing OTC
Business
- Travelan: Only clinically proven preventive product for
Traveler’s Diarrhea
- Early success: $1M+ sales in AUS/CAN; USA launch
(2Q2015) with strong sales commitment; Reg in China
- Worldwide market estimated at $600M+
Strong Pipeline
with
Blockbuster
Potential
- 2 Phase IIs in Fatty-Liver Disease (NASH) and ASH – No
approved therapies; $35-$40B market by 2030; ASH
study completed funded by NIH
- Pre-Clinical C-Difficile – Targeting toxin B, spores and
vegetative cells; $Multi-billion indication
Significant Near
Term Inflexion
Points
- Travelan growth in US and other territories; NASDAQ
listing; NASH progress; Results of C-Difficile pre-clinical
program
Valuation Gap
- Average PHII NASH Peer Companies: $260M
- Average C-Diff Peer Companies: $362M
6. Pipeline
Strong Asset Portfolio Mix
6
Pre-Clinical Phase 1 Phase 2 Phase 3 On Market
Launched in multiple geographies
Fatty-Liver Disease (NASH)IMM-124E
Alcoholic Steatohepatitis(ASH)
(Funded by the NIH)
IMM-124E
C-
Difficile
IMM-529
IMM-124E
IMM-124E
Diabetes
Colitis
7. FY2015
Year in Review
• US: Launch; 4 distribution partners signed
• Canada: Launch by Paladin (Endo)
• China: Distribution and registration agreement signed
• Protectyn: Launch of Liver Health brand in Australia
• WW: Multiple partnership discussions ongoing
7
OTC
Rx
Corporate
• NASH: Start of Phase II; Added new US and Israel sites; 36
patients enrolled; 10 in screening
• ASH: Start of Phase II; 22 patients recruited; Funded by NIH
• NASH/ASH: No significant AEs reported to date
• C-Difficile: Start of pre-clinical program
• Capital Consolidation Completed
• Hiring of key management staff (Head of Medical / NASH;
COO/CSO)
8. FY2015
Share Performance
8
Share Price Performance (July 1, 2014 – Nov 24, 2015)
RedChip Research
Report Released
TravelanUSLaunch
TravelanChina
Agreement Signed
NASH Recruitment
Update
9. FY2016
Major Goals and Objectives
• US: Accelerate market penetration
• China: CFDA approval; Push products through more
creative channels (Travelan/Protectyn)
• Protectyn: Launch in other territories
• Expand Geographic partners: Korea, EU, Japan, etc.
9
OTC
Rx
Corporate
• NASH: Completion of recruitment
• C-Difficile: Start of Phase 1/2
• Diabetes: Start of Phase 1/2
• Colitis: Start of pre-clinical studies
• NASDAQ Listing
10. FY2016 Summary
Focus on Three Key Valuation Levers to Rerate Valuation
10
Expand and Maximize
OTC Business
Execute Prioritized Rx
Program
NASDAQ Listing and
Careful Capital
Allocation
Dataroom Open for Scientific Due Diligence
14. Travelan®
A Unique Preventative Product
Without Travelan®:
Bacteria attach to gut wall
and infect
With Travelan®: Bacteria
neutralized by Travelan®
antibodies
The only therapy that
prevents Travelers’
Diarrhea by up to
90%
14
• Marketed in the US,
Australia by Immuron
and by Paladin/Endo in
Canada
• Global market estimate:
US$ 600M - 1.2B
• All-natural product;;
• Clinically proven
• SAFE
• OTC
• Strong brand loyalty
• Multiple life-cycle
opportunities
15. Travelan®
A Growing Global Brand
15
Regional Brand:
–Launched: US, CA, US
–In registration: China
and South Korea
Markets
Products
Customers
Consumer Focused:
–Travel Clinics
–Pharmacies
–Retail
One Brand:
–Travelan
Today Future
Global Brand:
–Expand to: Europe, Russia, Rest
of Asia,
–Own marketing and/or Licensing
All Relevant Channels:
–Consumer +
–Corporate, institutions,
schools, military, etc.
Multiple Brands:
–Pathogen(s) specific (e.g.,
Cholera; regional variances)
–Customized (e.g., Military)
–Combinations (e.g.:+probiotics)
17. • 25% of the US population has NAFLD
• 5% of the population will develop NASH
• No treatments approved
• All major pharma looking to get into the game
• Most treatments
‒ Do not capture the entire disease population
‒ Limited efficacy
‒ Severe / unknown side effect profile
17
Estimated Market Size: $35B - $40B USD by 2025 (Deutsche Bank)
NASH
A $35B-$40B Global Opportunity
IMM-124E Can Potentially Treat All Spectrum of Fatty-Liver Disease
18. Bile Acid
Shire - LUM-002
Intercept - Obeticholic acid, modified bile acid
Galmed - Aramchol, Conjugate of Fatty acid and Fatty
bile acid
Anti-fibrotic
Gilead - Simtuzumab, anti-fibrotic
Galectin - galectin proteins
Anti-Inflammatory + (anti-inflammatory, anti-
diabetic, cholesterol control, FFA)
Immuron – Oral enriched with Anti-LPS Abs
Tobira - CCR2 / CCR5 inhibitor
Genfit - Peroxisome proliferator
activated receptor alpha
18
NASH – Competitive Landscape
Room Exist for Many Therapies, and Combinations
IMM-124E DifferentiationCompetition
• Shuts down the underlying
cause of NASH, not just one
pathway
• Superior safety profile
• No safety concerns limiting
chronic / long term use
• Can be used across the
spectrum of NASH / NAFLD
• Can be used in combination
with other agents
• Oral vs. IV/SubQ
19. NASH
MULTI-CENTER, MULTI NATIONAL DOUBLE BLIND 2-DOSE
PLACEBO CONTROLLED
PRIMARY ENDPOINTS: CHANGES IN LIVER FAT CONFIRMED BY
MRI and CHANGES IN ALT
LEAD PRINCIPALINVESTIGATOR: ARUN SANYAL
22 SITES RUNNING(USA, Australia and Israel) & 3 MORE COMING
RECRUITING 120 SUBJECTS
35 PATIENTS ALREADY RANDOMIZED
NASH Phase II
Design and Recruitment
16
21. 21
Center for Disease Control (CDC)
Antibiotic Resistance Threats in the United States, 2013
C-Difficile
A Significant Unmet Need
22. - IMM-529 is combination vaccine that targets: Toxin B, C-Diff spores
and C-Diff vegetative cells
- Murine studies performed at Monash University, Australia:
- Prophylaxis – Demonstrating effectiveness in 80% of cases
- Treatment – Prevented death in 80% of cases
22
TreatmentProphylaxis
IMM-529
Toxin B Vaccine Developed to Defeat C-Diff
24. 24
Newsflow
12 – 18 Months
• OTC Business
– Expansion of Travelan in the US
– Approval and launch in China
– Expansion / Launch into EU
– Product line extensions
• Therapeutics
– NASH: Meeting recruitment target (June 2016);; PHII results (1H2017)
– C-Difficile: Results of pre-clinical studies;; Phase 1/2 start of results
– Diabetes: Start and results of Phase 1/2
– Colitis: Results of pre-clinical studies
• Corporate
– NASDAQ listing
25. 25
Immuron Limited
Investment Highlights
Significant and
Growing OTC
Business
- Travelan: Only clinically proven preventive product for
Traveler’s Diarrhea
- Early success: $1M+ sales in AUS/CAN; USA launch
(2Q2015) with strong sales commitment; Reg in China
- Worldwide market estimated at $600M+
Strong Pipeline
with
Blockbuster
Potential
- 2 Phase IIs in Fatty-Liver Disease (NASH) and ASH – No
approved therapies; $35-$40B market by 2030; ASH
study completed funded by NIH
- Pre-Clinical C-Difficile – Targeting toxin B, spores and
vegetative cells; $Multi-billion indication
Significant Near
Term Inflexion
Points
- Travelan growth in US and other territories; NASDAQ
listing; NASH progress; Results of C-Difficile pre-clinical
program
Valuation Gap
- Average PHII NASH Peer Companies: $900M
- Average C-Diff Peer Companies: $362M
26. Dr Roger Aston
Chairman
Daniel Pollock
Non-executive Director
Stephen Anastasiou
Non-executive Director
Peter Anastasiou
Executive Vice-Chairman
Thomas Liquard
Chief Executive Officer
Dan Peres, MD
Head of Medical
Jerry Kanellos, PhD
COO & Scientific Officer
Reza Moussakhani
Manufacturing Quality Director
Dr. Yaron Ilan
Medical and Scientific Advisor
Roger has more than 20 years of experience in the pharmaceutical and biotech industries. He was the
Founding 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 overseas new market entries, distribution agreements and corporate start-ups.
Stephen has extensive experience in general management, marketing and strategic planning in the
healthcare industry, formerly with KPMG.
Peter is the founder of major shareholder Grandlodge. He has had 20 years of successful investment
across many sectors. He started his first Biotech at age 23, and has a strong philanthropic portfolio.
Thomas spent the majority of his career at Pfizer in New York in various commercial positions and was
COO then CEO of Alchemia Limited, an oncology ASX biotech company.
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.
Dr Jerry Kanellos has over 20 years of experience in the pharmaceutical and biotech industries including
CMC, operations and business development. He has held senior roles at CSL and Transbio Limited.
A professional Operations manager with extensive experience in implementation of project / quality and
process improvements including with Hospiraand Sigma Pharmaceuticals.
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.
Corporate Structure
The Board and Management
26
29. 29
Extended Market Protection
Patent Portfolio and Biologic Pathway Confers Extended Protection
Patent Portfolio Biologics Protection
• Immuron’s drugs are
considered “biologics” by
the FDA and as such will
be reviewed under the
Biologics License
Application (BLA)
• In the US, this will confer
Immuron’s new drugs 12
years of market
exclusivity, offering
investors a long revenue
tail
30. 30
Platform Overview
Developing Customized Vaccines Targeted at Diseases
Vaccine
is
Developed
Targeting
Specific
Pathogens
Cows
Are
Immunized,
Creating
HyperImmune
Colostrum
HyperImmune
Colostrum
Is
Collected
1
2
3
Proprietary
methods
to
significantly
increase
levels
of
antibodies
of
choice
Cows
are
immunized
with
select
antigens in
the
last
trimester
of
pregnancy
to
produce
‘HyperImmunecolostrum’
(HIC)
HIC
contains
antibodies
to
all
the
pathogens
and
antigens
to
which
the
cows
have
been
exposed
to,
including
the
antibodies
against
the
antigens
used
to
immunize
the
cows;
Product
is
also
high
in
adjuvants
31. 31
Oral Immunotherapy
A differentiated Approach
An
approach
to
treat
autoimmune,
infectious
and
inflammatory
disease
through
the
oral
delivery
of
antibodies
and
adjuvants
An
active
process
that
uses
the
inherent
ability
of
the
GI
tract's
immune
system
to
control
unwanted
systemic
immune
responses,
by
inducing
systemic
regulatory
T
cells
to
suppress
inflammation
Disease Specific Antibodies
+
Colostrum Adjuvants Induction of
regulatory T-
cells
Target organs
• Liver
• Pancreas
• Adipose Tissue
• Brain
Presented in the Bowel
Oral Immunotherapy
• No side effects or toxicity
• Not associated with general
immune suppression
• No risks of severe infection
or malignancy
• Easily tolerated by patients
• Platform for a wide range of
diseases
1
2
32. Travelan®
Cross-Reactive Antibodies to Gram-Negative Bacteria
32
Traveler’s Diarrhea - Pathogens
Shah, Dupont, Ramsey; Am. J. Trop. Med. Hyg., 80(4), 2009, pp. 609–614
Global Etiologyof Travelers’ Diarrhea: Systematic Review from 1973to the Present
• Studies conducted with the
University of Maryland
demonstrated that Travelan
is cross-reactive to other
gram-negative bacteria
• Travelan therefore offers
protection against other
pathogenic bacteria such as
Shigella and Salmonella that
cause Traveler’s Diarrhea
• Ability to broaden appeal
and find new customers
(e.g., military)
Travelan: Beyond E-Coli
33. 33
Causing:
- Impaired gut epithelial integrity
- Increased gut permeability
- Increased LPS serum levels
NASH – Pathogenesis
Unique Properties
Gut flora
imbalance
Overgrowth of intestinal bacteria
incl. gram-negative bacteria
Drives:
- Increased BT from lumen into liver through
portal vein (70% of blood flow to liver)
- Increased hepatic / systemic inflammatory
response (e.g., TNF)
- Induction of systemic inflammation by
innate immune cells in the gut
- Increased concentration of immunoglobulin
(mainly IgG)
- Strong anti-LPS properties, Cross reactive
- Immuno-active adjuvants that promote
regulatory T-Cells; suppress systemic inflammation
- Not absorbed in the blood
- Immune modulation without immune suppression
Prevents
bacteria spread:
Binds and
neutralizes wide
range of LPS
Allows
lumen to
rebuild
integrity
Decreasing BT /
LPS levels
resulting in
decreased liver
inflammation
Decreases liver inflammation - Improves liver function
promotes regulatory T cells
systemically that suppress
inflammation at site
Alter the function
of innate immune
cells in the gut
Obesity is
associated with
a chronic
inflammatory
state
IMM-124E – MOA
1
2
Decrease systemic and local inflammation
Liver damage contributing to progression of steatosis
then NASH then onto fibrosis and eventually cirrhosis
Systemic inflammation: Inflammatory cells and cytokines
secreted systemically
IMM-124E
Compelling MOA in NASH
34. NKT
Macrophage
DC
DC
DC
M cell
B cell folliculeInterfollicular T cell area
Perifollicular area
Lamina Propria
Alteration of the GI immune system
Systemic immune imbalance
Systemic chronic inflammation
Bacterial antigens / Endotoxin
Basedon: Ilan Y, WorldJ Gastro, 2012 Hand TW.Science 2012;337.
34
The “Leaky Gut”
Fueling Inflammation
The “Leaky Gut” Translocation
• Translocation is not purely
passive
• It occurs via transcellular
pathways activated in
enterocytes by
inflammatory or metabolic
stresses
• Endotoxin/bacterial
antigens play a role in
activation of inflammatory
pathways
35. 35
Down regulation of inflammationin liver and other
organs (pancreas, Bowel)
Modified from:Ilan Y, PNAS, 2010
IMM-124E
Attacking Inflammation in Multiple Ways
Oral Anti-LPS + Adjuvants (Glycolipids)
Activates gut innate immune cells
Shut down bacterial
translocation
DC
Macrophage
Promotes Treg
Antibodies
presentation at
the gut
T Cells
T Regs
TGF-β
IL10
NKT Cells
37. Group
A:
Control
Group
D:
Treated
Group
B:
Naïve
anti
LPS
Group
C:
Treated
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;
Hepatology751A
Improved
Metavir Fibrosis
Score
37
IMM-124E
Pre-Clinical: Improves Inflammation and Fibrosis Markers
38. 38
IMM-124E
Phase I/IIa: Inflammatory Biomarkers
Mizrahi
M.
J
Inflamm
Res.
2012
Day
1 Day
30Increased GLP1 and Adiponectin
Increased
CD4+CD25+FOXP3+
TREGS
39. Mizrahi
M,
J
Inflamm
Res.
2012;5:141-‐50
39
Improved Liver Enzymes Improved HBA1C, OGTT and HOMA
IMM-124E
Phase I/IIa: Improves Liver Function and Insulin Resistance
Results of a Phase I/IIA clinical trial; N=10
30 Days Treatment: NO SAFETY ISSUES REPORTED