Immuron Investor Presentation - January 2014

ORAL IMMUNOTHERAPY USING BOVINE ANTIBODIES 1 Investor Presentation January 2014 Chief Executive Officer - Amos Meltzer Forward-looking Statement Certain statements made in this presentation are forward-l ooking statements and are based on Immuron’s current expectations, estimates and projecti ons. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "est imates," "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 uncertai nties, 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, ac tual results could materially differ from those expressed or forecasted in the forward-looking statements. The forward-looking statements made in this presentation r elate 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. 2 Investment highlight • Safe and proven technology platform • Rich product pipeline • Travelan ® approved and already in market generating sales – Revenues growing and set to accelerate. • 2 nd product: Fatty liver / NASH – an expected off-label use $3.2B market by 2016 in the US alone with no current treatment – Very positive Phase I/IIa results – FDA granted IND for Phase IIB trials for NASH – Red hot focus on companies developing NASH after Intercept Pharmaceuticals recently leapt from $1.5B to $8.5B on positive NASH trial. • 3 rd product: Preventative treatment for C. diff bowel infections. 3 4 Section 1 Company Overview Corporate Structure Rank Name Units (m) % of Units 1. GRANDLODGE PTY LTD 101.6 9.8 2. MR PETER ANASTASIOU + MRS KRISTINE PATRICIA ANASTASIOU <ANASTASIOU SUPER FUND A/C> 66.7 6.4 3. CHIMAERA CAPITAL LIMITED 65.0 6.3 4. HADASIT MEDICAL RESEARCH SERVICES & DEVELOPMENT LTD 59.2 5.7 5. FIFTY-FIFTH LEPRECHAUN PTY LTD <THE ANDRIA A/C> 50. 0 4.8 6. CAPITAL CONCERNS PTY LIMITED <LOGUE FAMILY SUPER FUND A/C> 34.9 3.37 7. MR DAVID ANTHONY PLUSH + MRS ANN LOUISE PLUSH <PLUSH SUPER FUND A/C> 33.4 3.22 8. G & N LORD SUPERANNUATION PTY LTD <GNR SUPERANNUATION FUND A/C> 20.4 1.97 9. INSYNC INVESTMENTS PTY LTD <WEEKLEY SUPER FUND NO 1 A/C> 19.0 1.83 10. MR HAMISH SALMON + MRS BRIGETTE MCGUIRE <SALMON FAMILY SUPER FUND A/C> 16.0 1.55 ASX Code IMC Shares on Issue 1,053,679,310 Current Share price 1.0 c Top 20 holders 55.4% New Cornerstone investors 5 Corporate Structure Board and Management • Chairman - Dr Roger Aston Founding CEO of Mayne Pharma Group; experience with FDA and EU product registration, clinical trials, global licensing agreements & fundraising • Non-executive Director – Daniel Pollock Internationally experienced lawyer with significant commercial expertise in new market entries into overseas markets, distribution agreements and corporate start-ups. • Non-executive Director – Stephen Anastasiou Extensive experience in general management, marketing and strategic planning in the healthcare industry, formerly with KPMG. • Chief Executive Officer – Amos Meltzer Technology commercialisation specialist with over 18 years experience in a diverse range of life science and other businesses. 6 The Platform Points of Difference 7 Product Other products /checkbldNatural product /xmarkbldSynthetic product /checkbldPowerful systemic immuno-modulatory effect /checkbldImmune modulation can be achieved /checkbldDoes not suppress immunity /xmarkbldCan suppress immunity /checkbldProven: no side effects or toxicity /xmarkbldSome side effects or toxicity /checkbldEasily tolerated by patients /xmarkbldNot easily tolerated by patients /checkbldPolyclonal Abs combat infectious diseases effectively /xmarkbldMonoclonal Abs are strain specific /checkbldOral administration /checkbldOral administration /checkbldRapid Development Cycle /xmarkbldLonger and substantially more costly development /checkbldHIC: multiple regulatory pathways, multiple revenue streams /xmarkbldOrdinarily: one regulatory pathway The Pipeline 8 Indication Research Pre-Clinical Phase I Phase II Phase III Market Traveller’s Diarrhea NASH (IMM-124E) ASH (IMM -124E) Clostridium difficile infection Other Projects: Related to Liver Related to IMM -124E And other indications 9 TRAVELAN Section 2 TRAVELAN The last 3 years 10 • Unique: Prevents travellers’ diarrhoea All other products are treatments and typically start to provide benefits only 48-72 hours after the onset of an attack • All Natural • Accessible: over-the-counter. • It works: Clinically proven, >90% efficacy Traveller’s diarrhoea market estimated between $600M and 1.2B globally TRAVELAN In Market, the last 3 years 0 1,000 2,000 3,000 4,000 5,000 6,000 Jan-10 Feb-10 Mar-10 Apr-10 May-10 Jun-10 Jul-10 Aug-10 Sep-10 Oct-10 Nov-10 Dec-10 Jan-11 Feb-11 Mar-11 Apr-11 May-11 Jun-11 Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11 Jan-12 Feb-12 Mar-12 Apr-12 May-12 Jun-12 Jul-12 Aug-12 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13 TRAVELAN License with Takeda Takeda shed its pharmacy sales force License Termination 11 TRAVELAN Australia Wholesalers R e t a I l e r s 12 R e t a I l e r s Wholesalers Previous arrangement: Current arrangement (from July 2013): Immuron is commanding substantially higher margin TRAVELAN Going Forward Approved In Discussion `` Various stages of regulatory process ``In Revenue In Discussion `` In Discussion Licensed `` Proceeding through regulatory process `` 13 14 IMM-124E for NASH Section 3 NASH How big is the opportunity? 15 Market cap: $8.5B January 9, 2014: Announces successful results in NASH clinical trials What this mean for Immuron: Scientifically • NASH is addressable Commercially • There is a huge, unmet opportunity. • NASH on the radar. Comparison: • Intercept’s drug increases bad cholesterol, reduces good cholesterol • Immuron’s drug has shown to do the opposite. Immuron may still be best in class Intercept Pharmaceuticals (NASDAQ: ICPT) $1.5B before more than quadrupling overnight on NASH trial results Market cap: $1.5B NASH The Epidemic Fatty liver: one of most common liver diseases in the industrialized world Non-Alcoholic Steatohepatitis (NASH): the most severe form of liver injury in the spectrum of non-alcoholic fatty liver disease Chronic Inflammatory Disease, associated with Obesity, Type II Diabetes (insulin resistance), Hyperlipidemia 1 in 5 NASH patients develop liver cirrhosis Leads to liver cancer NASH – An Epidemic of NCID : >25M AMERICANS WILL HAVE NASH BY 2025 THERE IS NO APPROVED DRUG ESTIMATE: OFF-LABEL MARKET ~$2B 16 IMM-124E for NASH Ready to go: Phase 2B trial Based on existing technology: - Mature manufacturing process - High Safety profile IMM-124E has been independently validated: selected as only 1 of 3 products to be studied for alcoholic steatohepatitis (ASH) under a fully funded NIH TREAT study IND cleared by the FDA: Immuron set to commence clinical trials Preparations under way Investigators identified NASH remains a very large unmet medical need of significant interest to the medical profession and the pharmaceutical industry 17 IMM-124E for NASH Mechanism of Action Oral Immunotherapy: An approach to treating autoimmune, infectious and inflammatory disease through the oral delivery of antibodies Scientific support for Immuron’s approach continues to grow Immuron has the right product at the right time 18 • Metabolic syndrome is a chronic inflammatory disorder associated with insulin resistance and hepatic steatosis. • Anti LPS colostrum (Imm124-E) is a bovine colostrum raised against LPS from an E.coli extract. • Imm124-E was shown to exert an immunomodulatory effect and to alleviate target organ damage in animal models. • Aim: To determine the safety and efficacy of oral administration of anti LPS colostrum to patients with insulin resistance and NASH. INTRODUCTION METHODS • In an open-label trial, 10 subjects with biopsy proven NASH and insulin resistance or diabetes type II were orally treated for 30 days with Imm124-E (600 mg a day). • Subjects were monitored for serum levels of insulin, adiponectin, and GLP-1 and for the changes of expression in peripheral regulatory T cells (Tregs). • Clinical effect was evaluated by: OGTT, liver enzyme, and lipid profile. The comparison was done between day 1 and day 30 for each patient. • Data analysis was carried out on responders. Improvement in early insulin secretion (6/10 Pt. p=0.07) Improvement in LDL levels (8/10 Pt.p=0.07) Administration of Imm124-E improved hepatocellular liver enzymes levels p<0.04. Improvement in HBA1C levels (9/10 Pt. p<0.001) CONCLUSION • Oral administration of Imm124-E exerts an immunomodulatory effect in subjects with insulin resistance or type 2 diabetes, hyperlipidemia and NASH. • The anti-inflammatory effect and promotion of peripheral Tregs, were in some of the responders associated with alleviation of insulin resistance and NASH in these subjects. Improvement in GLP1 secretion (6/10 Pt. p=0.07) Improvement in cholesterol levels 9/10 Pt. p<0.05) RESULTS 0.0 20.0 40.0 60.0 80.0 100.0 Day 1 Day 30 A L T le v e ls ( u /L ) 0.0 10.0 20.0 30.0 40.0 50.0 60.0 70.0 Day 1 Day 30 A S T le v e ls (u/L ) 0.0 20.0 40.0 60.0 80.0 100.0 120.0 Day 1 Day 30 AP levels (u/L) 0.0 20.0 40.0 60.0 80.0 100.0 120.0 Day 1 Day 30 GGT levels (u/L) Administration of Imm122-E improved cholestatic liver enzymes levels (7/10 Pt. p<0.002) 0.0 2.0 4.0 6.0 8.0 10.0 Day 1 Day 30 H b A 1 C 0.0 2.0 4.0 6.0 8.0 10.0 Day 1 Day 30 FPG (mmol/L) Improvement in FGT levels (6/10 Pt. p<0.06) 0 500 1000 Day 1 Day 30 I n s u l i n l e v e l s a f t e r 3 0 m i n ( p g / m l ) 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 Day 1 Day 30 Cholesterol levels ( µµµµM /dL) 0.0 2.0 4.0 6.0 8.0 Day 1 Day 30 Seru m LDL ( µµµµM/dL) 0 2 4 6 8 10 12 14 Day 1 Day 30 Serum GLP-1 (pM, X10 3) Increased Adiponestin secretion (8/10 Pt.p=0.08) 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 Day 1 Day 30 g a te d c e lls (% ) CD25 - PE C D 4 - F IT C -10 210 010 2 10 3 10 4 10 5 -10 1 10 2 10 3 10 4 10 5 CD4 0.39%44.94% 5.66%49.01% Day 1 Day 30 0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 Day 1 Day 30 gated cells (%) 30 Day 1Day 0.0 1.0 2.0 3.0 4.0 5.0 Day 1 Day 30 g a te d c e lls ( % ) 1Day 30 Day DISCLOSURE 0.0 10.0 20.0 30.0 40.0 50.0 60.0 Day 1 Day 30 gated cells (%) Increased N. of CD4+CD62+ cells (6/10 Pt. p<0.002) Increased N. of CD4+CD25+ cells (7/10 Pt. p<0.001) Increased N. of CD4+CD25+FOXp3 cells (7/10 Pt. p<0.001) Increased N. of CD4+CD25+HLA-DR cells (8/10 Pt.p<0.001) * Medical Director of Immuron. The study was supported by Immuron Ltd, Australia 0 2000 4000 6000 8000 10000 Day 1 Day 30 Adiponectin (ng/ml) Clinically Proven 20 R&D PIPE LINE Section 4 • Clostridium difficile (C.diff): a bacteria normally f ound in people’s intestines. • Certain circumstances C.diff can multiply and its toxin ca uses illness such as diarrhoea & severe inflammation of the bowel. C.diff infection accounts for: • considerable increases in length of hospital stays. • more than US$3.2 billion in health care costs each year in the United States. IMM-529 for Clostridium difficile 21 • IMM-529 under collaboration with Monash University • All data owned by Immuron • IMM-529 demonstrated positive pre-clinical results: • Encouraging preventative data • Treatment effect currently being investigated • Proprietary vaccine given to cows being improved IMM-529 for Clostridium Difficile Very encouraging results to date 22 23 LOOKING AHEAD Section 5 2013: THE ACHIEVEMENTS New Shareholders /checkbldApril rights issue: high net worth investors who provide a lot of support Travelan: continue commercialization /checkbldDirect-to-wholesale model in Australia, increase revenues /checkbldRegulatory approval in Canada /checkbldRegulatory progress in licensed territories /checkbldDiscussions in various territories progressing Fatty Liver / NASH /checkbldContinue preparation for Phase IIb Clinical trial /checkbldASH trial cleared by FDA /checkbldIndustry (potential partner) interest Clostridium difficile and other projects /checkbldVery encouraging preventative result. Treatment studies ongoing. /checkbldA number of promising applications, including for orphan conditions 24 LOOKING AHEAD What we are seeking to achieve Financial Strength /head2rightImprove balance sheet Travelan: continue commercialization /head2rightMore licenses /head2rightMore revenue Fatty Liver / NASH /head2rightCommence Phase IIb Clinical trial /head2rightPartner Progress R&D /head2rightProgress to the clinic with another product /head2rightA number of promising applications, including for orphan conditions We continue to nurture and benefit from strong partnerships with our R&D collaborators and with our commercial partners. 25 26 SUMMARY Section 6 THE OPPORTUNITY Immuron presents a unique opportunity: The near term future: Addressing large unmet medical need in red hot area: NASH / fatty liver . Positive Clinical results Potential: Orders of magnitude greater than the value of the Travelan business. Substantial support for this therapeutic from clinical results, key opinion leaders and the NIH. The present: Current market cap of ~$10M can be justified based on the company’s in-revenue Travelan business alone. Revenues are growing and set to accelerate. The infrastructure: Experienced Management Team Supportive shareholders Immuron’s retains control of its production. The rich pipe line: Immuron’s technology supports a rich pipeline of products. The time to market for Immuron’s products is accelerated on account of the high safety profile and the various regulatory options . 27 THE OPPORTUNITY Thank you Contact Amos Meltzer – Chief Executive Officer Ph: 0437 587 680 28

The release as fetched from its publisher. immuron.com.au ↗