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Immuron Limited
April 2018
Oral Immunoglobulins
Changing the Paradigms
of Care
www.immuron.com
ASX:IMC NASDAQ:IMRN
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.
Company Highlights
3
• Clinical stage biopharmaceutical company targeting inflammatory-mediated and
infectious diseases with oral immunotherapies
• Validated technology platform – with one registered asset generating revenue
• 2 Lead clinical assets in Phase 2 development for the treatment of multiple high value
indications, Fat Liver Disease and CDI.
• Excellent safety profile, GRAS by FDA, expedited regulatory review and approval
process
• High-value peer licensing deals and M&A underscore potential upside
• Experienced Management Team and strong support from leading KOLs and
institutions (NIH, DoD)
• Company listed on NASDAQ in 2Q 2017
Platform Overview: Oral Immunoglobulins
4
1
Vaccines Are
Developed
2
Antibodies Are Harvested
from Colostrum
Antigen Specific
Antibodies
(IgG and IgG1)
Adjuvants+
3
Broad Therapeutic Effect
+
• Reduced gut and blood pathogens
responsible for initiating
inflammation
• Reduces systemic inflammation
• Lowers organ injury
• Strong anti-toxin properties
• Decrease toxin levels results in
decrease gut damage
• Generally Regarded as Safe
(GRAS)
Induction of
regulatory
T-cells
Clearance of
Targeted GUT
Pathogens
Competitive
Advantage
• Platform capable of producing multiple drug candidates  Long-term value creation
• Bovine IgG possesses a unique ability to remain active in the human GI tract 
delivering its full benefits to the bacteria found there
• Bovine IgG is capable of withstanding the acidic environment of the stomach and is
resistant to proteolysis by the digestive enzymes in the GI tract
• Safety established  Not absorbed into the blood
Immuron’s Clinical Programs
Multiple Near-Term Inflection Points
5
Program Indications
Development Stage
Program Highlights
Pre-Clinical Phase 1 Phase 2 Phase 3
Anti-Inflammatory Programs
IMM-124E NASH - Topline results Available
IMM-124E ASH
- NIH Funded; UVA
- Topline results expected 2019
IMM-124E Pediatric NAFLD
- NIH Funded; Emory University
- Topline results expected 4Q 2018
IMM-124E Colitis
Collaboration with Dr. Rogler, Zurich
University
IMM-124E Autism
Murdoch Childrens Research
Institue,
La Trobe & RMIT Universities
Anti-Infective Programs
IMM-529 C. difficile
- Phase 1/2 initiated 4Q 2017
- Topline results expected Q1 2019
IMM-124E /
Shigella Vaccine
Shigella
Infections
Collaboration with US Army
IMM-124E
Campylobacter;
ETEC Infections
Collaboration with US Navy
• Hyperimmune bovine IgG powder 200mg
(30 caplets, 24 month shelf life)
• Reduces the risk of TD, reduces the
symptoms of minor GI disorders
TRAVELAN
6
Regulatory
Authority
Regulatory Pathway Indications
TGA Listed Medicine • Reduces the risk of travellers’ diarrhoea
• Reduces the symptoms of minor gastro-intestinal disorders
• Antimicrobial
Medsafe (New
Zealand)
Not marketed in New Zealand Not marketed in New Zealand
FDA (USA) Self-affirmed generally
regarded as safe (GRAS)
Dietary supplement. FDA does
not review dietary supplements
for safety and effectiveness
Hyperimmune colostrum dietary supplement
Health Canada Natural Health Product Travelan helps reduce the risk of traveller’s diarrhea.
EMA (Europe) Not marketed in Europe Not marketed in Europe
ARTG Listing for Travelan
http://www.travelanusa.com/
Australian Packaging
US Packaging
Prominent immune-reactive bands of
Campylobacter, ETEC and Shigella isolates
from Bhutan, Cambodia, Nepal and Thailand
7
Travelan immunoreactivity study:
• Armed Forces Research Institute of Medical Sciences (AFRIMS)
• Walter Reed Army Institute of Research (WRAIR)
• US Naval Medical Research Centre (NMRC)
Immuron Limited
March 2018
IMM-124E-2001 NASH Clinical Trial
Top Line Results
STUDY DESIGN IMM-124E-2001
9
Major Inclusion Criteria
Histologically proven NASH (≤12 months)
• NASH activity score (NAS) ≥4
• Cytologic ballooning score of at least 1
• 10% or more macrovesicular steatosis
• HBA1C of <9.0
SCREENING≤45D
IMM-124E 600 mg
IMM-124E 1200 mg
Placebo
FOLLOWUP4W
120 patients, 3-arms, Randomized, double
blind, Placebo – 2dose, balanced 1:1:1 design
10
STUDY ENDPOINTS
• Safety
• Hepatic Fat Fraction
PRIMARY
• liver enzymes – ALT, AST, GGT
• Glucose homeostasis and serum lipid profile
• Serum Bovine Ig – Pharmacokinetics
• Establish recommended dose
SECONDARY
• Lipopolysaccharides (LPS)
• CK-18
• Cytokines
• Adiponectin and GLP-1
MoA
STUDY POPULATIONS
11
Patients Screened: N = 237
Patients Randomized: N = 133
Study Analysis Sets:
ITT: 133FAS: 133PP: 102
Screening Failure n =
104
Early Discont. n = 21
Non-compliance n=8
Major deviations n=2
Definitions:
ITT = Intention to Treat
FAS = Full analysis set
PP = Per Protocol
SUMMARY: IMM-124E Clinical Trial Results
12
• First-In Class Anti-LPS Mechanism of Action
confirmed for IMM-124E
• Results demonstrate excellent safety and tolerability
• Statistically significant reduction in serum endotoxin/
Lipopolysaccharide (LPS) levels compared to
placebo
• Statistically significant reduction in mean serum ALT
in patients with elevated pre-treatment ALT
• Statistically significant Reduction of additional serum
NASH biomarkers associated with liver damage – AST
and CK-18
• IMM-124E retained within the GI tract and not
absorbed into the bloodstream, contributing to
favourable safety profile
• No effect on liver steatosis
FIRST IN CLASS MoA
LPS ANTAGONISM
13
• Hyperglycemia drives intestinal barrier dysfunction and risk for enteric infection. Thaiss CA et al. Science, 2018
• Non-alcoholic fatty liver and the gut microbiota. Stavros B et al. Molecular Metabolism, 2016
• Age-Associated Microbial Dysbiosis Promotes Intestinal Permeability, Systemic Inflammation, and Macrophage Dysfunction.
Thevaranjan N1, et al. Cell Host Microbe 2017.
• Hepatic TLR4 signaling in obese NAFLD. Sharifnia T, et al. Am J Physiol Gastrointest Liver Physiol 2015
• Obesity, Diet, Alcohol and
liver disease
• Dysbiosis
• “leaky gut” (LPS)
• Endotoxemia
• LPS engages TLR4
• lipogenesis,
inflammation, hepatocyte
apoptosis and fibrosis
NASH
SERUM ALANINE AMINO-TRANSFERASE (ALT)
RATE OF SUBJECTS WITH ≥30% DECREASE (n=94)*
14
30.3%
28.6%
14.3%
0%
5%
10%
15%
20%
25%
30%
35%
IMM 1200mg IMM 600mg PLB
* outlier sites excluded (site recruiting <3 patients) – as commonly practiced in clinical trials
p=0.107
SERUM ASPARTATE-AMINOTRANSFERASE AST
RATE OF SUBJECTS WITH AST DECREASE* >30%
(n=94)*
15
30.3%
14.3% 14.3%
0%
5%
10%
15%
20%
25%
30%
35%
IMM 1200mg IMM 600mg PLB
* excluded outlier sites
P=0.107
SERUM ALANINE AMINO-TRANSFERASE (ALT)
RATE OF SUBJECTS WITH ≥30% DECREASE*
16
36.4%
27.0%
13.6%
0%
5%
10%
15%
20%
25%
30%
35%
40%
IMM 1200mg IMM 600mg PLB
* excluded outlier sites, ALT BL >50
P=0.048
SERUM LIPOPOLYSACCHARIDES (LPS)
RATE OF PATIENTS WITH ≥15% DECREASE*
17
64.3%
59.1%
34.5%
0%
10%
20%
30%
40%
50%
60%
70%
IMM 1200mg IMM 600mg PLB
* Outlier sites excluded, Baseline LPS>250
P = 0.0184
SERUM LPS
OVERALL RESPONSE TO TREATMENT
TERTILE ANALYSIS
18
• Analysis aimed at
looking at the entire
population
• Shows an overall
beneficial effect across
all patients
• Minimizes risk of cut-off
selection bias
• p=0.0715 (1200mg vs.
PLB)
SERUM CYTOKERATINE-18 (CK-18)
RATE OF PATIENTS WITH ≥15% DECREASE (n=94)*
19
38.9%
15.2%
18.2%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
IMM 1200mg IMM 600mg PLB
P = 0.0494* excluded outliers sites
Disease Biology Provides Targets For
Therapeutics
20
SUMMARY
21
• IMM-124E targets inflammation a major disease driver
• Inflammation drives disease progression from NAFLD to
NASH to NASH fibrosis to NASH Hepatocellular
carcinoma and NASH Cirrhosis
• Our Medical Advisory Board was particularly interested in
further evaluating the compound in NASH cirrhosis
• Huge potential to treating patients exhibiting endotoxemia
and elevated gut permeability e.g. cirrhotics either NASH or
of any cause (evaluating on de-/compensated near
compensation
• “The potential clinical applications for this drug candidate
are numerous and very exciting indeed” – Immuron MAB
IMM-529
Neutralizing Clostridium difficile, while Sparing the
Microbiome
IMM-529 in Clostridium difficile Infection (CDI)
23
• Biologic with unique triple mechanism of action
- Targets and neutralizes the toxin B, the spores and the vegetative cells
• Potential to redefine the standard-of-care (SOC) therapy for CDI
- Stops virulence, without impacting the microbiome
- Compelling data in all three phases of the disease including (1) prevention of primary
disease, (2) treatment of primary disease and (3) prevention of recurrence
- Orally administrated, safe
• >70% survival rate in CDI mice treated with IMM-529 vs. <7% survival rate
in control groups
• Potential orphan disease designation; Potential breakthrough / fast track
designations
• Market exclusivity (biologics; High barriers to generic biosimilar entry)
IMM-529 for the Treatment of CDI
24
Market
Opportunity
• Therapeutic market is expected to grow from US$356.3 million in 2014 to over $1.5
billion by 2024 – CAGR 15%
• Nearly 30,000 patients die each year from C. difficile infections (US)
• Potential orphan disease (7 years market exclusivity and premium pricing)
Unmet Need
• Vancomycin and metronidazole are the current standard of care, accounting for 80% of
patient share (US)
• However, therapies are plagued by significant CDI recurrences (1st relapse: 25%; 2nd:
40%; 3rd: 50%) underscoring need for new treatments
• There is also growing resistance to vancomycin treatment
IMM-529
Positioning
• Highly differentiated – Neutralizes C. difficile but does not impact microbiome
• Only asset that targets not only toxin B but also the spores and the vegetative cells
responsible for recurrence
• Can be used in combination with standard of care
• Targets many isolates
Sources: GlobalData, Decision Resources, CDC
Triple Action MOA
Neutralizing C. difficile; Sparing the Microbiome
25
Spores – Infectious Particles
IMM-529 antibodies bind to
multiple epitopes on surface
antigens on spores and
prevent adheres to host cells
and limit germination.
Heat, ethanol and UV
resistant. Survive gastric acid,
adhere to cells in the colon
and germinate.
Vegetative Cells
IMM-529 antibodies bind to
multiple epitopes on the
surface layer proteins (SLP)
on vegetative cells and limit
colonization.
Fimbriae and other surface
layer proteins (SLP) contribute
to bacterial colonization.
Fimbriae are used to adhere to
other bacteria and to host cells
and is one of the primary
mechanisms of virulence
Toxin B
IMM-529 antibodies bind to
multiple epitopes effectively
neutralize toxin B, inhibiting toxin
mediated epithelial cell apoptosis
and limit toxin translocation into
the systemic circulation and
inflammatory cascades.
Toxin B is essential for
virulence. Toxin B disrupt the
cytoskeleton and tight
junctions of intestinal epithelial
cells.
3
1
2
Results of Pre-Clinical Studies
Hutton et al; Scientific Reports June 2017 | 7: 3665 | DOI:10.1038/s41598-017-03982-5
26
0 .0 0 .5 1 .0 1 .5 2 .0 2 .5 3 .0 3 .5 4 .0
0
2 0
4 0
6 0
8 0
1 0 0
S u rv iv a l
h o u rs p o s t in fe c tio n
Percentsurvival
U n in fe c te d , N o tre a tm e n t
In fe c te d , N o tre a tm e n t
In fe c te d , N o n -im m u n e Ig G tre a tm e n t
In fe c te d , IM M -5 2 9 tre a tm e n t
In fe c te d , V a n c o m y c in tre a tm e n t
PreventionStudies
Demonstrated ~70%
survival rate without
use of antibiotics vs.
0% for control group
(P<0.0001)
All studies
statistically
significant
TreatmentStudies
Demonstrated ~80%
survival rate without
use of antibiotics vs.
<7% in control group
(P<0.0001)
0 1 2 3 4
0
2 0
4 0
6 0
8 0
1 0 0
D a y s p o s t in fe c tio n
Percentsurvival
S u rv iv a l
In fe c te d , N o tre a tm e n t
In fe c te d , N o n -im m u n e Ig G tre a tm e n t
In fe c te d , IM M -5 2 9 tre a tm e n t
In fec te d , V a n c o m y c in trea tm e n t
U n in fe c te d , N o tre a tm e n t
RelapseStudies
Demonstrated ~20%
relapse rate vs.
~89% relapse rate in
control group
(P<0.0027)
Potentially only
therapeutic
(approved or in
development) that
can treat all
phases of the
disease:
1.Prophylaxis
2.Treatment
3.Recurrence
0 2 4 6 8 1 0 1 2 1 4 1 6 1 8 2 0
0
1 0
2 0
3 0
4 0
5 0
6 0
7 0
8 0
9 0
1 0 0
1 1 0
S u rv iv a l
D a y s a fte r v a n c o m y c in tre a tm e n t c e a s e d
Percentsurvival
In fe c te d + S O C
In fe c te d + S O C + IM M -5 2 9**
p=0.0027
Phase 1/2 Study Design
27
• Phase 1/2, randomized, double blind, placebo-controlled clinical study of IMM-529
for the treatment of CDI
• 60 subjects to be enrolled up to 3 weeks of definitive diagnosis of CDI (at least 20
subjects to be enrolled within the first 72 hours)
• Subjects randomized to IMM-529 or placebo in a 2:1 ratio
• Treatment duration: 28 days on top of SOC (vancomycin / metronidazole)
• Follow-up: 3 months overall
• Primary objective: To evaluate the safety and tolerability of IMM-529 together with
standard of care (SOC) in patients with CDI
• Secondary objective: To evaluate the effectiveness of IMM-529 together with SOC to
treat patients with CDI
Phase 1/2 Study in CDI Initiated 4Q 2017
NASH and C. difficile Comps Indicate
Potential for Substantial Growth
28
Company Ticker Program Development Stage Market Cap*
Program in NASH
ICPT Obeticholic acid Phase 3 US$2.9B
GNFT Elafibranor Phase 3 US$1.1B
CNAT ENCORE-LF Phase 2 US$195M
Program in C. Difficile
MCRB SER-109; SER-262 Phase 2 US$423M
SMMT SMT19969 Phase 1 US$143M
ASMB ABI-M101 Preclinical US$419M
*As of May 4, 2017
Capital Profile Immuron Limited (ASX:IMC NASDAQ:IMRN)
29
Current Unmerged
Top 10 Shareholders
Current Company
Market Capitalization
AUD$47.83M ≈ USD$37.13M
At Current Share Price = AUD$0.335 (18th April 2018)
Rank Holder Name Current Qty %
1 HSBC CUSTODY NOMINEES (Incl. US ADR Program) 14,427,779 10.11%
2 CITICORP NOMINEES PTY LIMITED (Incl. Empery US) 14,250,941 9.98%
3 * GRANDLODGE PTY LTD 9,556,682 6.69%
4 AUTHENTICS AUSTRALIA PTY LTD 8,624,999 6.04%
5 * MR PETER ANASTASIOU 2,907,236 2.04%
6 INVERAREY PTY LTD 2,731,632 1.91%
7 INSYNC INVESTMENTS PTY LTD 2,500,000 1.75%
8 * ADVANCE CLINICAL SYSTEMS 2,296,874 1.61%
9 * MR STEPHEN ANASTASIOU & 2,035,371 1.43%
10 MR WILLIAM DAVID FRANK BIRD 2,006,000 1.40%
TOTAL TOP 20 SHAREHOLDERS 61,337,514 42.96%
BALANCE OF SHARES 81,440,692 57.04%
TOTAL SHARE ON ISSUE 142,778,206 100.00%
* Denotes a Director Related Entity
Key Milestones Expected to Drive Value
30
• IMM-124E
- NASH Phase 2 study
closed
• IMM-529
- Initiation of Phase
1/2 Trial in CDI
• IMM-124E
- NASH Phase 2
topline results
• IMM-124E
- NASH centric
transaction
- Pediatric NAFLD
Phase 2 topline
results
• IMM-124E
- ASH Phase 2 topline
results
• IMM-529
- Topline results expected
from Phase 1/2 study in
CDI
4Q
2017
1Q
2018
2018 2019
Results from colitis preclinical studies and US
Army and US Navy trials expected 2018
Thank You

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Immuron Corporate Presentation - April 2018

  • 1. Immuron Limited April 2018 Oral Immunoglobulins Changing the Paradigms of Care www.immuron.com ASX:IMC NASDAQ:IMRN
  • 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.
  • 3. Company Highlights 3 • Clinical stage biopharmaceutical company targeting inflammatory-mediated and infectious diseases with oral immunotherapies • Validated technology platform – with one registered asset generating revenue • 2 Lead clinical assets in Phase 2 development for the treatment of multiple high value indications, Fat Liver Disease and CDI. • Excellent safety profile, GRAS by FDA, expedited regulatory review and approval process • High-value peer licensing deals and M&A underscore potential upside • Experienced Management Team and strong support from leading KOLs and institutions (NIH, DoD) • Company listed on NASDAQ in 2Q 2017
  • 4. Platform Overview: Oral Immunoglobulins 4 1 Vaccines Are Developed 2 Antibodies Are Harvested from Colostrum Antigen Specific Antibodies (IgG and IgG1) Adjuvants+ 3 Broad Therapeutic Effect + • Reduced gut and blood pathogens responsible for initiating inflammation • Reduces systemic inflammation • Lowers organ injury • Strong anti-toxin properties • Decrease toxin levels results in decrease gut damage • Generally Regarded as Safe (GRAS) Induction of regulatory T-cells Clearance of Targeted GUT Pathogens Competitive Advantage • Platform capable of producing multiple drug candidates  Long-term value creation • Bovine IgG possesses a unique ability to remain active in the human GI tract  delivering its full benefits to the bacteria found there • Bovine IgG is capable of withstanding the acidic environment of the stomach and is resistant to proteolysis by the digestive enzymes in the GI tract • Safety established  Not absorbed into the blood
  • 5. Immuron’s Clinical Programs Multiple Near-Term Inflection Points 5 Program Indications Development Stage Program Highlights Pre-Clinical Phase 1 Phase 2 Phase 3 Anti-Inflammatory Programs IMM-124E NASH - Topline results Available IMM-124E ASH - NIH Funded; UVA - Topline results expected 2019 IMM-124E Pediatric NAFLD - NIH Funded; Emory University - Topline results expected 4Q 2018 IMM-124E Colitis Collaboration with Dr. Rogler, Zurich University IMM-124E Autism Murdoch Childrens Research Institue, La Trobe & RMIT Universities Anti-Infective Programs IMM-529 C. difficile - Phase 1/2 initiated 4Q 2017 - Topline results expected Q1 2019 IMM-124E / Shigella Vaccine Shigella Infections Collaboration with US Army IMM-124E Campylobacter; ETEC Infections Collaboration with US Navy
  • 6. • Hyperimmune bovine IgG powder 200mg (30 caplets, 24 month shelf life) • Reduces the risk of TD, reduces the symptoms of minor GI disorders TRAVELAN 6 Regulatory Authority Regulatory Pathway Indications TGA Listed Medicine • Reduces the risk of travellers’ diarrhoea • Reduces the symptoms of minor gastro-intestinal disorders • Antimicrobial Medsafe (New Zealand) Not marketed in New Zealand Not marketed in New Zealand FDA (USA) Self-affirmed generally regarded as safe (GRAS) Dietary supplement. FDA does not review dietary supplements for safety and effectiveness Hyperimmune colostrum dietary supplement Health Canada Natural Health Product Travelan helps reduce the risk of traveller’s diarrhea. EMA (Europe) Not marketed in Europe Not marketed in Europe ARTG Listing for Travelan http://www.travelanusa.com/ Australian Packaging US Packaging
  • 7. Prominent immune-reactive bands of Campylobacter, ETEC and Shigella isolates from Bhutan, Cambodia, Nepal and Thailand 7 Travelan immunoreactivity study: • Armed Forces Research Institute of Medical Sciences (AFRIMS) • Walter Reed Army Institute of Research (WRAIR) • US Naval Medical Research Centre (NMRC)
  • 8. Immuron Limited March 2018 IMM-124E-2001 NASH Clinical Trial Top Line Results
  • 9. STUDY DESIGN IMM-124E-2001 9 Major Inclusion Criteria Histologically proven NASH (≤12 months) • NASH activity score (NAS) ≥4 • Cytologic ballooning score of at least 1 • 10% or more macrovesicular steatosis • HBA1C of <9.0 SCREENING≤45D IMM-124E 600 mg IMM-124E 1200 mg Placebo FOLLOWUP4W 120 patients, 3-arms, Randomized, double blind, Placebo – 2dose, balanced 1:1:1 design
  • 10. 10 STUDY ENDPOINTS • Safety • Hepatic Fat Fraction PRIMARY • liver enzymes – ALT, AST, GGT • Glucose homeostasis and serum lipid profile • Serum Bovine Ig – Pharmacokinetics • Establish recommended dose SECONDARY • Lipopolysaccharides (LPS) • CK-18 • Cytokines • Adiponectin and GLP-1 MoA
  • 11. STUDY POPULATIONS 11 Patients Screened: N = 237 Patients Randomized: N = 133 Study Analysis Sets: ITT: 133FAS: 133PP: 102 Screening Failure n = 104 Early Discont. n = 21 Non-compliance n=8 Major deviations n=2 Definitions: ITT = Intention to Treat FAS = Full analysis set PP = Per Protocol
  • 12. SUMMARY: IMM-124E Clinical Trial Results 12 • First-In Class Anti-LPS Mechanism of Action confirmed for IMM-124E • Results demonstrate excellent safety and tolerability • Statistically significant reduction in serum endotoxin/ Lipopolysaccharide (LPS) levels compared to placebo • Statistically significant reduction in mean serum ALT in patients with elevated pre-treatment ALT • Statistically significant Reduction of additional serum NASH biomarkers associated with liver damage – AST and CK-18 • IMM-124E retained within the GI tract and not absorbed into the bloodstream, contributing to favourable safety profile • No effect on liver steatosis
  • 13. FIRST IN CLASS MoA LPS ANTAGONISM 13 • Hyperglycemia drives intestinal barrier dysfunction and risk for enteric infection. Thaiss CA et al. Science, 2018 • Non-alcoholic fatty liver and the gut microbiota. Stavros B et al. Molecular Metabolism, 2016 • Age-Associated Microbial Dysbiosis Promotes Intestinal Permeability, Systemic Inflammation, and Macrophage Dysfunction. Thevaranjan N1, et al. Cell Host Microbe 2017. • Hepatic TLR4 signaling in obese NAFLD. Sharifnia T, et al. Am J Physiol Gastrointest Liver Physiol 2015 • Obesity, Diet, Alcohol and liver disease • Dysbiosis • “leaky gut” (LPS) • Endotoxemia • LPS engages TLR4 • lipogenesis, inflammation, hepatocyte apoptosis and fibrosis NASH
  • 14. SERUM ALANINE AMINO-TRANSFERASE (ALT) RATE OF SUBJECTS WITH ≥30% DECREASE (n=94)* 14 30.3% 28.6% 14.3% 0% 5% 10% 15% 20% 25% 30% 35% IMM 1200mg IMM 600mg PLB * outlier sites excluded (site recruiting <3 patients) – as commonly practiced in clinical trials p=0.107
  • 15. SERUM ASPARTATE-AMINOTRANSFERASE AST RATE OF SUBJECTS WITH AST DECREASE* >30% (n=94)* 15 30.3% 14.3% 14.3% 0% 5% 10% 15% 20% 25% 30% 35% IMM 1200mg IMM 600mg PLB * excluded outlier sites P=0.107
  • 16. SERUM ALANINE AMINO-TRANSFERASE (ALT) RATE OF SUBJECTS WITH ≥30% DECREASE* 16 36.4% 27.0% 13.6% 0% 5% 10% 15% 20% 25% 30% 35% 40% IMM 1200mg IMM 600mg PLB * excluded outlier sites, ALT BL >50 P=0.048
  • 17. SERUM LIPOPOLYSACCHARIDES (LPS) RATE OF PATIENTS WITH ≥15% DECREASE* 17 64.3% 59.1% 34.5% 0% 10% 20% 30% 40% 50% 60% 70% IMM 1200mg IMM 600mg PLB * Outlier sites excluded, Baseline LPS>250 P = 0.0184
  • 18. SERUM LPS OVERALL RESPONSE TO TREATMENT TERTILE ANALYSIS 18 • Analysis aimed at looking at the entire population • Shows an overall beneficial effect across all patients • Minimizes risk of cut-off selection bias • p=0.0715 (1200mg vs. PLB)
  • 19. SERUM CYTOKERATINE-18 (CK-18) RATE OF PATIENTS WITH ≥15% DECREASE (n=94)* 19 38.9% 15.2% 18.2% 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% IMM 1200mg IMM 600mg PLB P = 0.0494* excluded outliers sites
  • 20. Disease Biology Provides Targets For Therapeutics 20
  • 21. SUMMARY 21 • IMM-124E targets inflammation a major disease driver • Inflammation drives disease progression from NAFLD to NASH to NASH fibrosis to NASH Hepatocellular carcinoma and NASH Cirrhosis • Our Medical Advisory Board was particularly interested in further evaluating the compound in NASH cirrhosis • Huge potential to treating patients exhibiting endotoxemia and elevated gut permeability e.g. cirrhotics either NASH or of any cause (evaluating on de-/compensated near compensation • “The potential clinical applications for this drug candidate are numerous and very exciting indeed” – Immuron MAB
  • 22. IMM-529 Neutralizing Clostridium difficile, while Sparing the Microbiome
  • 23. IMM-529 in Clostridium difficile Infection (CDI) 23 • Biologic with unique triple mechanism of action - Targets and neutralizes the toxin B, the spores and the vegetative cells • Potential to redefine the standard-of-care (SOC) therapy for CDI - Stops virulence, without impacting the microbiome - Compelling data in all three phases of the disease including (1) prevention of primary disease, (2) treatment of primary disease and (3) prevention of recurrence - Orally administrated, safe • >70% survival rate in CDI mice treated with IMM-529 vs. <7% survival rate in control groups • Potential orphan disease designation; Potential breakthrough / fast track designations • Market exclusivity (biologics; High barriers to generic biosimilar entry)
  • 24. IMM-529 for the Treatment of CDI 24 Market Opportunity • Therapeutic market is expected to grow from US$356.3 million in 2014 to over $1.5 billion by 2024 – CAGR 15% • Nearly 30,000 patients die each year from C. difficile infections (US) • Potential orphan disease (7 years market exclusivity and premium pricing) Unmet Need • Vancomycin and metronidazole are the current standard of care, accounting for 80% of patient share (US) • However, therapies are plagued by significant CDI recurrences (1st relapse: 25%; 2nd: 40%; 3rd: 50%) underscoring need for new treatments • There is also growing resistance to vancomycin treatment IMM-529 Positioning • Highly differentiated – Neutralizes C. difficile but does not impact microbiome • Only asset that targets not only toxin B but also the spores and the vegetative cells responsible for recurrence • Can be used in combination with standard of care • Targets many isolates Sources: GlobalData, Decision Resources, CDC
  • 25. Triple Action MOA Neutralizing C. difficile; Sparing the Microbiome 25 Spores – Infectious Particles IMM-529 antibodies bind to multiple epitopes on surface antigens on spores and prevent adheres to host cells and limit germination. Heat, ethanol and UV resistant. Survive gastric acid, adhere to cells in the colon and germinate. Vegetative Cells IMM-529 antibodies bind to multiple epitopes on the surface layer proteins (SLP) on vegetative cells and limit colonization. Fimbriae and other surface layer proteins (SLP) contribute to bacterial colonization. Fimbriae are used to adhere to other bacteria and to host cells and is one of the primary mechanisms of virulence Toxin B IMM-529 antibodies bind to multiple epitopes effectively neutralize toxin B, inhibiting toxin mediated epithelial cell apoptosis and limit toxin translocation into the systemic circulation and inflammatory cascades. Toxin B is essential for virulence. Toxin B disrupt the cytoskeleton and tight junctions of intestinal epithelial cells. 3 1 2
  • 26. Results of Pre-Clinical Studies Hutton et al; Scientific Reports June 2017 | 7: 3665 | DOI:10.1038/s41598-017-03982-5 26 0 .0 0 .5 1 .0 1 .5 2 .0 2 .5 3 .0 3 .5 4 .0 0 2 0 4 0 6 0 8 0 1 0 0 S u rv iv a l h o u rs p o s t in fe c tio n Percentsurvival U n in fe c te d , N o tre a tm e n t In fe c te d , N o tre a tm e n t In fe c te d , N o n -im m u n e Ig G tre a tm e n t In fe c te d , IM M -5 2 9 tre a tm e n t In fe c te d , V a n c o m y c in tre a tm e n t PreventionStudies Demonstrated ~70% survival rate without use of antibiotics vs. 0% for control group (P<0.0001) All studies statistically significant TreatmentStudies Demonstrated ~80% survival rate without use of antibiotics vs. <7% in control group (P<0.0001) 0 1 2 3 4 0 2 0 4 0 6 0 8 0 1 0 0 D a y s p o s t in fe c tio n Percentsurvival S u rv iv a l In fe c te d , N o tre a tm e n t In fe c te d , N o n -im m u n e Ig G tre a tm e n t In fe c te d , IM M -5 2 9 tre a tm e n t In fec te d , V a n c o m y c in trea tm e n t U n in fe c te d , N o tre a tm e n t RelapseStudies Demonstrated ~20% relapse rate vs. ~89% relapse rate in control group (P<0.0027) Potentially only therapeutic (approved or in development) that can treat all phases of the disease: 1.Prophylaxis 2.Treatment 3.Recurrence 0 2 4 6 8 1 0 1 2 1 4 1 6 1 8 2 0 0 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 0 1 0 0 1 1 0 S u rv iv a l D a y s a fte r v a n c o m y c in tre a tm e n t c e a s e d Percentsurvival In fe c te d + S O C In fe c te d + S O C + IM M -5 2 9** p=0.0027
  • 27. Phase 1/2 Study Design 27 • Phase 1/2, randomized, double blind, placebo-controlled clinical study of IMM-529 for the treatment of CDI • 60 subjects to be enrolled up to 3 weeks of definitive diagnosis of CDI (at least 20 subjects to be enrolled within the first 72 hours) • Subjects randomized to IMM-529 or placebo in a 2:1 ratio • Treatment duration: 28 days on top of SOC (vancomycin / metronidazole) • Follow-up: 3 months overall • Primary objective: To evaluate the safety and tolerability of IMM-529 together with standard of care (SOC) in patients with CDI • Secondary objective: To evaluate the effectiveness of IMM-529 together with SOC to treat patients with CDI Phase 1/2 Study in CDI Initiated 4Q 2017
  • 28. NASH and C. difficile Comps Indicate Potential for Substantial Growth 28 Company Ticker Program Development Stage Market Cap* Program in NASH ICPT Obeticholic acid Phase 3 US$2.9B GNFT Elafibranor Phase 3 US$1.1B CNAT ENCORE-LF Phase 2 US$195M Program in C. Difficile MCRB SER-109; SER-262 Phase 2 US$423M SMMT SMT19969 Phase 1 US$143M ASMB ABI-M101 Preclinical US$419M *As of May 4, 2017
  • 29. Capital Profile Immuron Limited (ASX:IMC NASDAQ:IMRN) 29 Current Unmerged Top 10 Shareholders Current Company Market Capitalization AUD$47.83M ≈ USD$37.13M At Current Share Price = AUD$0.335 (18th April 2018) Rank Holder Name Current Qty % 1 HSBC CUSTODY NOMINEES (Incl. US ADR Program) 14,427,779 10.11% 2 CITICORP NOMINEES PTY LIMITED (Incl. Empery US) 14,250,941 9.98% 3 * GRANDLODGE PTY LTD 9,556,682 6.69% 4 AUTHENTICS AUSTRALIA PTY LTD 8,624,999 6.04% 5 * MR PETER ANASTASIOU 2,907,236 2.04% 6 INVERAREY PTY LTD 2,731,632 1.91% 7 INSYNC INVESTMENTS PTY LTD 2,500,000 1.75% 8 * ADVANCE CLINICAL SYSTEMS 2,296,874 1.61% 9 * MR STEPHEN ANASTASIOU & 2,035,371 1.43% 10 MR WILLIAM DAVID FRANK BIRD 2,006,000 1.40% TOTAL TOP 20 SHAREHOLDERS 61,337,514 42.96% BALANCE OF SHARES 81,440,692 57.04% TOTAL SHARE ON ISSUE 142,778,206 100.00% * Denotes a Director Related Entity
  • 30. Key Milestones Expected to Drive Value 30 • IMM-124E - NASH Phase 2 study closed • IMM-529 - Initiation of Phase 1/2 Trial in CDI • IMM-124E - NASH Phase 2 topline results • IMM-124E - NASH centric transaction - Pediatric NAFLD Phase 2 topline results • IMM-124E - ASH Phase 2 topline results • IMM-529 - Topline results expected from Phase 1/2 study in CDI 4Q 2017 1Q 2018 2018 2019 Results from colitis preclinical studies and US Army and US Navy trials expected 2018

Editor's Notes

  1. Hello everyone and thank you for taking the time to meet with IMMURON today stock symbol IMRN on the NASDAQ and IMC on the ASX My name is JK CEO and I would like to walk you through some of the key company milestones we have achieved to date First of all I would like to thank Dave Genry and the RedChip team for the invitation to present at this conference it is a great opportunity for me to provide you all with a corporate update on the progress the company has made I first started doing the Investor Road shows with RedChip in August last year and at the time our Market Capitilization was under 20 million AUD Today our MC is just under 50 million AUD and I have a brief presentation which covers some of the major milestones achieved to date which have been the driving force behind the increase in our SP and I will also highlight some near term inflection points which are due in the next 12 months which we believe will drive value in our stock
  2. Slide 2 covers the forward looking statements which we are required by law to make sure all investors are aware of and you should take the necessary time to review before making any investment decisions
  3. SLIDE 3 – Provides an Overview of the Company for you who are new to IMMURON IMRN is a clinical stage biotechnology company – Biologics We have 2 lead clinical assets targeting high value inflammation and infectious diseases The company listed on the NASDAQ in June 2017 raising 6 million USD and we have just completed a Capital Raise of 4 million USD on the back of our phase 2 NASH data which we reported in March this year. We have enough money in the bank to drive our development programs forward well into 2019. What makes us different? We believe we have transformative therapies to that can be the standard of care Phase IIs in NASH; Use for all treatments C. difficile – Potential to displace all current therapies Great progress in last ~2 years of so Growing body of evidence to support this view – Why our stock has been doing so well What it matters? Where is the value for our investors? Near-term and long-term Opportunity to be Tobira, bought by $500M by Allergan (5x market cap) or Intercept/Genfit which are $1B companies Well established M&A/BD playbook – we are not reinventing the well Plenty of milestones to drive the upside Lead inflammatory program expected to report interim data in Q3 and topline results before year end Lead infectious disease program to commence Phase 1/2 study in Q3 HOW MUCH are you prepared to Invest in IMRN? Keep on driving value for the long-term Have an impact – not only on patients but on value for shareholders
  4. Slide 4 provides an overview of our technology platform which is based on orally active immunoglobulins derived from engineered hyper-immune bovine colostrum This technology platform has the capability to produce highly specific immunoglobulins to any pathogenic bacteria we choose to target and Has the capability of delivering multiple new drug candidates for clinical evaluation which will drive long term value creation for the company The products are designed to work in the gut targeting pathogenic bacteria there and have been clinical proven NOT to be absorbed into the blood stream hence the excellent safety profile Why bovine IgG Bovine IgG is capable of withstanding the acidic environment of the stomach and is resistant to proteolysis by the digestive enzymes in the GI tract making them ideal candidates for oral drug delivery
  5. Slide 5 provides you with an overview of our Research and Development pipeline We currently have 4 phase II clinical trials on going 3 of our trials are focused on Fatty Liver Diseases (NASH, we also have two NIH funded studies in Pediatric NAFLD and ASH we have just initiated a clinical study in Clostridium difficle infection which is one of the hospital super bugs We also have a robust preclinical portfolio focused on Infectious diseases with the US DoD (Campylobacter, ETEC and Shigella) and have programs targeting IBD such as Colitis and we have a program focused on Autism Spectrum Disorder Driving Multiple ongoing therapeutic programs to late-stage clinical development with multiple key millstones over the next 6 to 9 months
  6. Our flagship product Travelan® was first approved in 2004 as a listed medicine on the Australian Register of Therapeutic Goods (AUST L 106709) Travelan contains high levels of specific antibodies which have been generated against 13 strains of Enterotoxigenic E.coli bacteria, the most common cause of Travellers’ Diarrhea Travelan directly targets the pathogens in the gut that are implicated in Travellers’ Diarrhea and prevents the infection and its resulting symptoms from occurring in the first place The product achieved 1.3 million AUD in Sales last year on track to reach 2 million AUD this year Significant growth in USA major customer – Passport Health ~ 200 travel medicine clinics
  7. The product has gained the attention of the U.S. Department of Defense (DoD) who have been investing in the development of an effective vaccine against enteric diseases for over for over 20 years The findings of the recent research program conducted by the Department of Enteric Diseases, Armed Forces Research Institute of Medical Sciences in Bangkok, Thailand an overseas laboratory of the Walter Reed Army Institute of Research (WRAIR) was reported in January The primary goal of this program was to investigate Travelan® immunological reactivity with pathogenic bacteria including Campylobacter, Enterotoxigenic E-coli and Shigella. The tested bacterial isolates originated from the AFRIMS’s library of infectious diseases The pathogenic bacteria were retrieved from infected personnel deployed in Bhutan, Cambodia, Nepal and Thailand over a 20 year period Results reported demonstrated that the antibodies in Travelan® were able to bind and reactive to ALL 180 strains of bacteria tested by Western blot analysis demonstrating the broad spectrum antimicrobial properties of the product Travelan® showed particularly strong reactivity to 60 clinical isolates of personnel infected with ETEC and 60 personnel infected with Shigella
  8. I would like to go over the top line results of our phase 2 NASH clinical study The goal is to show the main outcomes of the study while further analyses are still being ran
  9. The IMM-124E NASH clinical study The study Design consisted of a 3 arm, randomized double blind , placebo vs. 2 doses of IMM-124E The major aim of the study was to recruit 120 patients with a histologically proven positive NASH liver biopsy and HbA1c Allocation was done at a 1:1:1 ratio Stratification performed according to country, HbA1c and HFF at baseline Eclusion attepted to remove any confounding factors such as other liver diseases
  10. The Study primary endpoint included safety of IMM-124 compared to the placebo group HFF was another primary and will be discussed separately The Secondary endpoints were the most commonly used endpoints which examine liver damage, metabolism and pharmacokinetics – which is unique to our product Additional endpoints were put in plalce to better define liver injury and the MoA
  11. Immuron screened a total of 237 patients Enrolling a total of 133 found eligible according to the study criteria 31 subjects were removed from the Per Protocol final analysis if they did not reach the 24 weeks visit or a major protocol violation was identified 102 patients successfully completed the 24 week treatment as per the clinical protocol
  12. Slide 12 summarize our topline results reported in March 2018 It is important to remember that Our drug candidate IMM-124E has been developed to target the endotoxin LPS in the gut and prevent it translocating into the portal circulation. The major study hypothesis was if you decrease the reservoir of endotoxin in the gut you reduce the source and supply of the major driver of inflammation in the disease The endotoxin LPS has been widely reported in the literature to be a major mediator of inflammation and a major driver of NASH A literature search of LPS and NASH produces over 800,000 scientific articles The study results we reported in March clearly demonstrate a statistically significant reduction of serum LPS levels in the treatment groups when compared to placebo and provides us with a proof of concept that metabolic endotoxemia can indeed be decreased using this drug candidate (IMM-124E) which targets the endotoxin LPS.
  13. A few words on IMM-124E MoA The Gut microbiota is the normal microbe population living in our intestine. Our gut microbiota contains tens of trillions of microorganisms, including at least 1000 different species of known bacteria  Dysbiosis is a term used to refer to a microbial imbalance inside the body, in an impaired microbiota - good bacteria get over run by pathogenic bad bacteria The Gut liver axis refers to imbalances of normal microbes in the gut which can directly impact the health of our livers LPS Antagonist could potentially target Autism, IBD (Colitis), NASH Liver Cirrhosis, etc
  14. The same anlysis was done for all patients showing a statistical trend * = outlier sites excluded (site recruiting <3 patients) - as commonly practiced in clinical trails
  15. Same as with ALT, AST is showing a statistical trend to reduce AST by 30% or more This accumulates to a significant overall drug effect
  16. And now to the results … we’ve managed to show that more than twice as many subjects treated by 1200 mg demonstrated a 30% or greater reduction in serum ALT ALT is widely used in all NASH studies and is associated with liver necro-inflammation a recent scientific review prof. Ratziu, one of the world leading KOL on NASH presented the most accepted endpoint for NASH studied ALT was ranked the highest amongst serum markers though non specific it is important to show improvement fot he diseased liver Prof. Ratziu further detemened that a significant reduction in ALT would be 30-40%
  17. Lipopolysaccharide, endotoxin, are fragments of gram negative bacteria Various factors change the bacterial composition within the gut leading to increase in intraluminal LPS which in-turn translocate into the blood stream
  18. To show effect across the entire population
  19. Another serum marker showing the level of liver cell death (apoptosis) is CK-18 Though sample size is relatively small and variability is high we’ve been able to demonstrate a statistically significant decrease when comparing 1200mg to placebo
  20. Inflammation is the major driver of disease NAFLD to NASH fibrosis to NASH Hepatocellular carcinoma and NASH Cirrhosis Targeting inflammation is the key to an effective NASH therapeutic
  21. We believe this to be a huge unmet medical need and the regulatory path has been previously established by the FDA. The additional data expected to be generated from our Alcoholic Steatohepatitis study in Q1 next year should support this as well as our pediatric NAFLD A LPS Antagonist could potentially target a wide range of diseases from Autism, IBD (Colitis), NASH, Liver Cirrhosis, endotoxemia There are over 3 million scientific articles on LPS associated diseases Medical Advisory Board The primary objective of the study was to evaluate the safety and efficacy of IMM-124E, at two oral dosage levels as compared with a placebo and provide proof of concept in human subjects for its unique Mechanism of Action Significant reduction of liver Transaminases (ALT and AST) markers of liver injury
  22. Moving to our second Clinical stage asset – IMM-529 Our second clinical asset targets the Gram positive, spore forming toxin producing anaerobe C. difficile Pathogenic C. difficile strains produce toxins that cause diarrhoea and mediate gut damage The bacteria is resistant to most clinical antibiotics It is the leading cause of infectious antibiotic-associated diarrhoea in hospitals and healthcare facilities worldwide C. difficile only colonises the gut if the normal microbiota is disrupted People at greatest risk include those on antibiotics, the elderly and immunocompromised patients The current Standard of Care treatment is antibiotics Vancomycin and metronidazole
  23. Our product targets the three infectious phases of the diseases, the highly infectious spores, the germinating cells that colonize the gut and produce toxins which damage the gut WE have produced Compelling data in all three phases of the disease including (1) prevention of primary disease, (2) treatment of primary disease and (3) prevention of recurrence Some background Gut overgrowth of a bacteria named Clostridium difficile rising concern with increasing incidence attributed to Antibiotic therapy SOC is effective but doesn’t make sense - search for alternative therapies IMM-529 based on the same platform hence safety unique combination of 3 types of antibodies creating a tri-component MOA Anti Toxin B Ig the current leading target fro therapy polyclonal antibodies to bacteria polyclonal antibodies to spores Does not affect the Microbiome as SOC As before uniquely positioned to be the therapy of choice per safety and MOA
  24. Slide 24 shows that CDI represents a significant market opportunity and an unmet need due to the rising incidence as well as limited efficacy in preventing recurrence current SOC therapies are plagued by significant disease recurrences once you are infected with the bacteria you have a 25% chance of being reinfected once reinfected the chances of being reinfected again increase to 40% and then 50% (1st relapse: 25%; 2nd: 40%; 3rd: 50%) underscoring need for new treatments Let move to slide 27
  25. EFFICACY comprehensive preclinical program in prevention, treatment and prevention of recurrence makes IMM-529 applicable to all indication of CDI with a massive unmet need and huge potential market in each one
  26. rolling out our phase 1/2 clinical study Enrolling 60 subjects To demonstrate safety within the acute and post acute disease to Efficacy - affect disease parameters and rate of recurrence With results expected in 2018 it should generate massive value moving into our next clinical development phase
  27. As an investor this is an exciting time for Immuron. The competitive landscape truly underscores our the potential for significant upside
  28. I know you are busy / your time is precious. We love what we are doing at Immuron because we believe that we are developing very high value assets, that will change who diseases are treated. So I will walk through the story in a minute, but first a bit of grounding
  29. Slide 30 covers our report card for the next 12 months Why Immuron….Why now…The next 12-18 months will be transformative for Immuron with multiple value driving milestones I would like to thank you once again for your time and look forward to addressing any questions in the Q&A session