COMPANY PRESENTATION
November 2015
Forward-Looking Statement
Certain statements made in this presentation are forward-looking statements and are based onImmuron’s current expectations, estimates and projections. Words such as “anticipates,” “expects,”“intends,” “plans,” “believes,” “seeks,” “estimates,” “guidance” and similar expressions are intended toidentify 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 commercializingtechnology. As a result, actual results could materially differ from those expressed or forecasted inthe forward-looking statements.
The forward-looking statements made in this presentation relate only to events as of the date onwhich the statements are made. Immuron will not undertake any obligation to release publicly anyrevisions or updates to these forward-looking statements to reflect events, circumstances orunanticipated events occurring after the date of this presentation except as required by law or by anyappropriate regulatoryauthority.
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Immuron LimitedCompany 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 Valuation Upside – Company currently valued at ~AUS$35M3
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Causing:- Impaired gut epithelial integrity- Increased gut permeability- Increased LPS serum levels
NASH – Pathogenesis
Unique PropertiesGut flora imbalance
Overgrowth of intestinal bacteriaincl. 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-124ECompelling MOA in NASH
5
Immuron LimitedInvestment Highlights
Significant and Growing OTCBusiness
- 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
PipelineStrong Asset Portfolio Mix
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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-DifficileIMM-529
IMM-124E
IMM-124E
Diabetes
Colitis
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
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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)
FY2015 Share Performance
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Share Price Performance (July 1, 2014 – Nov 24, 2015)
RedChip Research Report Released
Travelan US Launch
Travelan China Agreement Signed
NASH Recruitment Update
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.
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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
FY2016 SummaryFocus on Three Key Valuation Levers to Rerate Valuation
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Expand and Maximize OTC Business
Execute Prioritized Rx Program
NASDAQ Listing and Careful Capital
Allocation
Dataroom Open for Scientific Due Diligence
FinancialsStrong Financial Position
• Ticker: ASX (Australia): IMC
• Share price (11/14/15): $0.46
• Liquidity: $700,000 – $800,000/month
• Shares outstanding: 75M
• Market Cap: $35M
• Cash (as of 30/06/2015): $3.1M
• Debt: $011
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PEER COMPARISONNASH and C-Diff Comparables
C-Difficile Peer Comparables
NASH Peer ComparablesCompany Ticker Share
Price Share Price (52w
High/Low) Asset Stage Cash Debt Market Cap EV
Intercept ICPT $167.64 $128.50 -‐ $314.88 Phase III $700M $0 $4.1B $3.4BTobira TBRA $10.17 $7.20 -‐ $24.31 Phase II $69M $15M $111M $57MGalectin GALT $2.40 $1.68 -‐ $4.68 Phase II $21M $0 $57M $36MGalmed GLMD $8.22 $4.58 -‐ $13.50 Phase II $23M $1M $95M $71MGenfit GNFT $37.99 $24.61 -‐ $70.64 Phase II $67M $4M $978M $915MConatus CNAT $3.18 $2.70 -‐ $11.74 Phase II $15M $1M $62M $48MGilead GILD $106.61 $85.95 -‐ $108.05 Phase II $15B $22B $155B $162B
Average (not including Gilead) $901M $754MAverage (Phase IIs, not including Gilead) $260M $225M
Company Ticker Share Price
Share Price (52w High/Low) Asset Stage Cash Debt Market
Cap EV
Seres Therapeutics MCRB $33.00 $25 -‐ $52 Phase II $222 $5 $1.26B $1.04BAssembly Biosciences ASMB $9.14 $6.51 -‐ $20.50 Pre-‐Clinical $66 $12 $154M $100MSynthetic Biologics SYN $2.81 $1.39 -‐ $4.32 Phase II $32 $10 $230M $208MSummit Therapeutics SUMM.L $10.73 $8.84 -‐ $14.78 Phase II $41 $0 $131M $90MAmpliPhi Biosciences APHBD $5.86 $2.75 -‐ $16.75 Lead Opt. $12 $3 $33M $24M
Average $362M $292M
OTC BUSINESS
Travelan®A Unique Preventative Product
Without Travelan®: Bacteria attach to gut wall
and infect
With Travelan®: Bacteria neutralized by Travelan®
antibodies
The only therapy that prevents Travelers’ Diarrhea by up to
90%
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• Marketed in the US, Australia by Immuronand by Paladin/Endo in Canada
• Global market estimate: US$ 600M - 1.2B
• All-natural product;;
• Clinically proven
• SAFE
• OTC
• Strong brand loyalty
• Multiple life-cycle opportunities
Travelan®A Growing Global Brand
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Regional Brand:–Launched: US, CA, US– In registration: China
and South Korea
Markets
Products
CustomersConsumer 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)
NASH
• 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
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Estimated Market Size: $35B - $40B USD by 2025 (Deutsche Bank)
NASHA $35B-$40B Global Opportunity
IMM-124E Can Potentially Treat All Spectrum of Fatty-Liver Disease
Bile Acid Shire - LUM-002Intercept - 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 inhibitorGenfit - Peroxisome proliferator activated receptor alpha
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NASH – Competitive LandscapeRoom 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
NASHMULTI-CENTER, MULTI NATIONAL DOUBLE BLIND 2-DOSE PLACEBO CONTROLLED
PRIMARYENDPOINTS: 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 IIDesign and Recruitment
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C-DIFFICILE
21
Center for Disease Control (CDC)Antibiotic Resistance Threats in the United States, 2013
C-DifficileA Significant Unmet Need
- 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
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TreatmentProphylaxis
IMM-529Toxin B Vaccine Developed to Defeat C-Diff
SUMMARY
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Newsflow12 – 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
Immuron LimitedInvestment Highlights
Significant and Growing OTCBusiness
- 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
Dr Roger AstonChairman
Daniel PollockNon-executive Director
Stephen AnastasiouNon-executive Director
Peter AnastasiouExecutive Vice-Chairman
Thomas LiquardChief Executive Officer
Dan Peres, MDHead of Medical
Jerry Kanellos, PhD COO & Scientific Officer
Reza MoussakhaniManufacturing Quality Director
Dr. Yaron IlanMedical 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 PharmaGroup 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 StructureThe Board and Management
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THANK YOU
APPENDICES
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Extended Market ProtectionPatent 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
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Platform OverviewDeveloping Customized Vaccines Targeted at Diseases
Vaccine is Developed Targeting Specific
Pathogens
Cows Are Immunized, Creating
HyperImmuneColostrum
HyperImmuneColostrum 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
Oral ImmunotherapyA differentiated Approach
An approach to treat autoimmune, infectious and inflammatory disease through the oral delivery of antibodies and adjuvantsAn 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
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. 609–614Global Etiology of Travelers’ Diarrhea: Systematic Review from 1973 to the Present
• Studies conducted with the University of Maryland demonstrated that Travelanis 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
Causing:- Impaired gut epithelial integrity- Increased gut permeability- Increased LPS serum levels
NASH – Pathogenesis
Unique PropertiesGut flora imbalance
Overgrowth of intestinal bacteriaincl. 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-124ECompelling MOA in NASH
NKT
Macrophage
DCDC
DCM 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
Based on: Ilan Y, World J 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
Down regulation of inflammation in liver and other organs (pancreas, Bowel)
Modified from: Ilan Y, PNAS, 2010
IMM-124EAttacking Inflammation in Multiple Ways
Oral Anti-LPS + Adjuvants (Glycolipids)
Activates gut innate immune cellsShut down bacterial translocation
DCMacrophage
Promotes Treg
Antibodies presentation at
the gut
T Cells
T Regs
TGF-βIL10
NKT Cells
Mizrahi M. 2013, AASLD; Hepatology751A36
Fibrotic LiverCCl4 (carbon tetrachloride)
IMM-124E LiverCCl4 (carbon tetrachloride)
IMM-124E
IMM-124EPre-Clinical: Significant Impact on Liver Fibrosis
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-124EPre-Clinical: Improves Inflammation and Fibrosis Markers
38
IMM-124EPhase I/IIa: Inflammatory Biomarkers
Mizrahi M. J Inflamm Res. 2012
Day 1 Day 30Increased GLP1 and Adiponectin
Increased CD4+CD25+FOXP3+ TREGS
Mizrahi M, J Inflamm Res. 2012;5:141-‐50 39
Improved Liver Enzymes Improved HBA1C, OGTT and HOMA
IMM-124EPhase 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
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