Immuron Ltd — Investor Presentation 2016

May 30, 2016

May 2016

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1 2 3 Antibodies Are Vaccines Are Harvested from Broad Therapeutic Effect Developed Colostrum Induction - Reduces systemic of inflammation regulatory - T-cells Lowers organ injury - Not associated with general + immune suppression - No risks of severe infection Disease Bovine Clearance of + or malignancy Specific adjuvants Targeted - Antibodies IgG (IgG1) Pathogens Easily tolerated by patients

• Not associated with general immune suppression

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An approach to treat inflammatory, infectious and autoimmune diseases through the oral delivery of antibodies and adjuvants

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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

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Protectyn

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Other Launches (eg. Japan)

Additional Growth Opportunities

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$13.9M
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EU Full Year Launch

USA, China Full Year EU Launch USA Launch (Late 2016) $8.1M $4.6M $1.8M

Geographies: EU, Potential Rx + Japan and Russia Extensions

Product Line Extensions

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– Dr Arun Sanyal (MD) University of Virginia. Professor of Medicine and Former Chairman of the Division of

– Dr Stephen Harrison (MD) Professor of Medicine, Uniformed Services University of the Health Sciences, Bethesda,

– Dr Manal Abdelmalek (MD) Duke University Medical Center. Dr Abdelmalek is Associate Professor of Medicine at

– Dr Gerhard Rogler (MD, PhD) Zurich University. Dr Rogler is the Chairman of the Scientific Advisory Board of the

– Dr Miriam Vos (MD) Emory University. Dr Vos is an associate professor of pediatrics at the Emory University School of

– Dr. Dena Lyras (PhD) Monash University. Dr Lyras is associate professor at Monash University, is one of the world’s

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Financials Overview

Share Price Performance (Mar 15- May 16)

NASH C-Difficile Recruitment Results Update CVS

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Travelan
US Launch
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Chief Executive Officer

Head of Medical & NASH

COO & Scientific Officer

Medical and Scientific Advisor

Manufacturing Quality Director

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NASH

Obesity / Unhealthy Living…

… Drives Metabolic Diseases

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• Metabolic syndrome is associated with the risk of developing cardiovascular disease, diabetes and fatty liver

• Some studies have shown the prevalence in the USA to be an estimated 34% of the adult population; Prevalence increases with age

• No end in sight to the epidemic: e.g.: 350 – 550 million people expected to be diabetic by 2030

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NASH: The most severe form of liver injury in the spectrum of nonalcoholic fatty liver disease (NAFLD)

Market Estimated to top $35B-$40B WW by 2030 driven by Size obesity epidemic (Deutche Bank – 2014)

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NASH – Pathophysiology

Key Takeaways

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Immunological Mechanisms

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IMM-124E

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GUT:

• Intestinal LPS ↓

• Intestinal Permeability ↓

• Microbiome antigen change

• Tolerance – Activation of Innate system to suppress inflammation (NKT, DC, macrophages)

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LIVER:

• Activated Kupffer Cells ↓ (F4/80 macrophages)

• Fibrosis and Inflammation ↓

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SERUM:

• Insulin resistance ↓

• Circulating LPS ↓

• TGF-β ↑

• TNF-α ↓

• IL-2, IL-6, IL-10, IL-12

• Treg ↑ (CD4, CD25, FoxP3)

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Anti-LPS and Adjuvants in IMM-124E A Synergistic Effect in Animal Models of NASH

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900
800
700

600
500
400
300
200
100
0
ALT levels (u/L)
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Results

lowering Triglycerides and liver enzymes in the

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* P<0.05; ** P<0.009
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An adjuvant effect through the gut

Adar T. Clin Exp Immunol., 2012

synergistic effect

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Fibrotic Liver

CCl4 (carbon tetrachloride)

IMM-124E Liver CCl4 (carbon tetrachloride)

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IMM124E

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Treatment with IMM-124E prevents Fibrosis and Inflammation

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Mizrahi M. 2013, AASLD; Hepatology 751A

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Group A: Group B: Naïve Group A: Group B:
Control anti LPS
Control Naïve anti LPS
Group C: Group D: Group C: Group D:
Treated Treated Treated Treated
Decrease Portal Inflammation Improved Metavir Fibrosis Score
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4 3.4 p<0.0009
3.5 ^^ p<0.0003
3
2.5
1.8
2
1.5 1
1
0.5
0
0
A B C D
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3
2.4 p<0.02
2.5 ^^ p<0.01
2
1.4 1.33
1.5
0.66
1
0.5
0 Mizrahi M. 2013,
A B C D AASLD;
Hepatology 751A
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Results of a Phase I/IIA clinical trial; N=10 30 Days Treatment Endpoint Met; NO SAFETY ISSUES REPORTED

Improved Liver Enzymes

Improved HBA1C, OGTT and HOMA

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Mizrahi M, J Inflamm Res. 2012;5:141-50

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Increased CD4+CD25+FOXP3+ TREGS

Increased GLP1 and Adiponectin

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Day 1

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Day 30

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Mizrahi M. J Inflamm Res. 2012

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Lead Principal Investigator: Arun Sanyal; Former President of the AASLD (American Association for the Study of Liver Diseases) and current Chair of the Liver Study Section at the NIH (National Institute of Health) Scope: Multi-Center, Developed Countries, Double-Blinded, Placebo controlled trial Sites: 25 sites running in US, Australia and Israel; 1 more to be added in 1H2016

Recruiting 120 patients with biopsy proven NASH; 44 patients already randomized; 18 patients have completed treatment

3 Arms: Placebo, High Dose and Low Dose

Primary Endpoints: Changes in Liver Fat Content confirmed by MRI; Changes in ALT (liver

Secondary Endpoints / Outcome Measures: E.g., Changes in BMI, Changes in

Timing: Top Line Results (TLR) by Mid-2017

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Competition

Bile Acid

Shire - LUM-002

Intercept - Obeticholic acid, modified bile acid

Galmed - Aramchol, Conjugate of Fatty acid and Fatty bile acid

Anti-fibrotic

IMM-124E Strong Differentiation

• Represents a mufti-factorial approach to NASH, not just one pathway

• Potentially superior safety profile - No safety issues as reported by competitors (e.g., Intercept with LDL)

Gilead - Simtuzumab, anti-fibrotic

Galectin - galectin proteins

Anti-Inflammatory + (anti-inflammatory, antidiabetic, cholesterol control, FFA)

• No significant safety concerns that would limit chronic / long term use

• Can be used across the spectrum of NASH / NAFLD

Immuron – Oral enriched with Anti-LPS Abs

Tobira - CCR2 / CCR5 inhibitor

Genfit - Peroxisome proliferator activated receptor alpha

• Can be used in combination with other agents

• Oral vs. IV/SubQ

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IMM- • Safety profile potentially opens all segments (Fibrosis – F0-F4 and NAFLD)
•
124E Can potentially be used in combination with other agents, not only as monotherapy
Liver
Cancer
39K
US incidence
Galectin
Cirrhosis Conatus 0.63% of US Adults: Combo-therapy
potential
off label use potential 600K patients
Intercept: Recruiting F1 - F3
IMM-529
Genfit: Recruiting F1 - F3
F0 – F3; Mono
NASH Galmed: TBD 2-3% of US adults: 5-7M patients or Combo
Tobira: TBD
Therapy
Payor pushback for use in F0/F1
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X 19% of US Adults: 45M patients MonoNAFLD Likely limited offtherapy label use The prevalence of NAFLD is 80-90% in obese adults, 30-50% in patients Potential with diabetes and up to 90% in patients with hyperlipidemia

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C-DIFFICILE

Market Opportunity

Unmet Need

IMM-529 Positioning

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Spores – Infectious Particles

IMM-529 antibodies bind to surface antigens on spores & prevent adheres to host cells & limit germination.

Heat, ethanol & UV resistant. Survive gastric acid, adhere to cells in the colon & germinate

Vegetative Cells

Fimbriae & other surface layer proteins (SLP) contribute to bacterial colonization. Fimbriae are used to adhere to other bacteria & to host cells and isone of the primary mechanisms of virulence

IMM-529 antibodies bind to SLP on vegetative cells & limit colonization.

Toxin B

IMM-529 antibodies neutralise toxin B, inhibiting toxin mediated epithelial cell apoptosis & limit toxin translocation into the systemic circulation & inflammatory cascades

Toxin B is essential for virulence. Toxin B disrupt the cytoskeleton and tight junctions of intestinal epithelial cells

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S u rv iv a l
1 0 0
U n in fe c te d , N o tre a tm e n t
8 0 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
6 0 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
4 0
2 0
0
0 .0 0 .5 1 .0 1 .5 2 .0 2 .5 3 .0 3 .5 4 .0
h o u rs p o s t in fe c tio n
S u rv iv a l
1 0 0 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
8 0 In fe c te d , N o n -im m u n e Ig G tre a tm e n t
6 0 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
4 0
2 0
0
0 1 2 3 4
D a y s p o s t in fe c tio n
1 1 0 S u rv iv a l
1 0 0 In fe c te d + S O C
9 0 ** In fe c te d + S O C + IM M -5 2 9
8 0 p=0.0027
7 0
6 0
5 0
4 0
3 0
2 0
1 0
0
0 2 4 6 8 1 0 1 2 1 4 1 6 1 8 2 0
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
P e rc e n t s u rv iv a l
P e rc e n t s u rv iv a l
Studies P e rc e n t s u rv iv a l
Prevention
Studies
Treatment
Relapse Studies
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Demonstrated 80% efficacy without use

Demonstrated 80% efficacy without use

Demonstrated ~90% survival rate vs. 22% survival rate in control

All studies statistically significant

Potentially only therapeutic (approved or in development) that can treat all phases of the disease:

(1) Prophylaxis (2) Treatment

(3) Recurrence

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Phase I/II

If positive

Phase IIA / IIB

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OTC BUSINESS

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The only therapy that
prevents Travelers’
Diarrhea by up to
90%
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Without Travelan [®] : With Travelan [®] : Bacteria
Bacteria attach to gut wall neutralized by Travelan [® ]
and infect antibodies
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• 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

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• Significantly reduces adherence of CFA/I producing ETEC strains to a cell-line that mimics the human small intestinal epithelium

PreClinical Studies

• Significantly reduces the motility of ETEC strains through soft agar

• Binds to both the bacterial surface and flagella

• Has substantially greater reactivity against purified ETEC flagella antigen than IgG purified from non-immune colostrum powder

• Travelan has undergone clinical testing in patient randomised, double-blind, placebo-controlled clinical trials (90 patients)

Clinical Studies

• Results: Travelan confers protection of nearly 91% against infection of the major strain of E.coli that causes TD

• In addition these trials showed a significant reduction in abdominal cramps and stomach pain compared to those who did not receive Travelan. There were no reported treatment-related side effects

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Formulated with 13 Strains of E-Coli

Proven to Be Cross-Reactive (binds) to Other E-Coli Strains and Gram-Negative Bacteria

Formulated with 13 E-Coli	Strains of
Serotype	Strains�#
ETEC O6: H16	B2C
ETEC O8: H19	C55 3/3c3
ETEC O15: H4	PE 595
ETEC O25: H42	E11881A
ETEC O27: HR	C1067-77
ETEC O63: H-	PE 673
ETEC O78: H11	H10407
ETEC O114: H21	E20738/0
ETEC O115: H-	PE 724
ETEC O128: H21	EI 37-2
ETEC O148: H28	B7A
ETEC O153: H12	E8772/0
ETEC O159: H-	PE 768

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Other Launches (eg. Japan)

Additional Growth Opportunities

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$13.9M
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EU Full Year Launch USA, China Full Year EU Launch USA Launch (Late 2016) $8.1M $4.6M $1.8M

Geographies: EU, Potential Rx + Japan and Russia Extensions

Product Line Extensions

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OUTLOOK & VALUE

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• (2016) Acquired Nimbus Phase I ACC inhibitor for $400m upfront + potential for future payments (total deal up to $800M)

• (2010) Acquired Arresto for $225m + potential for future payments : Phase I asset (LoxL2 antibody) targeting NASH, IPF

• • (2015) Phenex : Acquired NASH asset with Phase II running. Total deal value $470m . Undisclosed upfront, development

• (2012) Regulus: Preclinical deal. AZN paid $125m per

• (2014) Acquired Lumena for $260m . Company had two

• Total potential deal value $600m for 2 indications. A$39m

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Leader in NASH; In PIII; Positive Phase II funded by NIH ; Significant safety issues (e.g., LDL); $6B+ valuation increase with positive PII

Microbiome Leader; in PII in C-Diff; Only open-label Phase 1/2 positive; very strong institutional support

In PIII; Negative PII (placebo response very high); Lost 500M euro valuation on negative PII

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• Average valuation for PII NASH companies: $54M US (2.5X current valuation)

• Average valuation for PIII NASH companies: $2.1B (100X current valuation)

• Average C-Diff Companies: $367M

• All NASH companies in PII: - Tobira: Finishing PII

• • Galectin: Cirrhotic patients
• • Conatus: Cirrhotic patients
• • Galmed: Just initiated PII; Recruiting slowly

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APPENDICES

• 7 Major patent families offering both matter of composition and formulation patents

Strong Patent Portfolio

• Approved / pending in major geographies including US, Europe, Japan, China

• Earliest patent to 2026; possible extension to 2030

• Immuron’s drugs are considered “biologics” by the FDA

Extended Market Exclusivity

• In the US, this will confer Immuron’s new drugs 12 years of market exclusivity, offering investors a long revenue tail

• Exclusively effectively extend time to potential first generic entry

• Immuron’s drug not absorbed in the blood

Generic Protection

• No baseline for PK studies

• This results in lengthy process for Gx manufacturers with many opportunities to challenge ANDA fillings

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THANK YOU