NASH & ASH Clinical Trial Update

Suite 1, 1233 High Street Armadale, Victoria AUSTRALIA 3143 www.immuron.com ABN: 80 063 114 045 Phone: + 61 (0)3 9824 5254 Facsimile: + 61 (0)3 9822 7735 Final Preparations Underway for Commencement of ASH and NASH Clinical Trials Melbourne, Australia - 15 October 2014 : Australian biopharmaceutical company Immuron Limi ted (ASX: IMC) is nearing initiation of two separate clinical trials with final preparations underway for non-al coholic steatohepatitis (NASH) and alcoholic steatohepatitis (ASH). Both trials are investigating Immuron’s therapeutic candidate IMM-142E, a bovine colostrum formulation enriched with anti-LPS antibodies, and both are exp ected to be initiated before the end of the year as previously advised. Both trials are designed as pla cebo-controlled, double-blinded and dose ranging mu lti- centre studies. The NASH Trial Immuron’s Phase II trial has been cleared to commence by the United States Food and Drug Administration (US FDA) and Immuron is currently finalising prepar ations. Immuron is funding the Phase II trial in 1 20 NASH patients all of whom will be treated for six months with IMM-124E. In support of commencing the trials, the Company ha s engaged the services of data management and clinical monitors. The monitors’ first task is to e nsure that participating hospitals have a pool of r elevant patients and are equipped to carry out the trial. I mmuron’s appointed monitors have already assessed a nd approved the Company’s selected hospitals in Austra lia and the United States. Hospital ethics submissi ons are underway with the first ethics approval expecte d later this month. Each hospital is required to ob tain ethics clearance from its internal ethics committee , the principal purpose of which is to ensure the t rial does not unduly place patients at risk. Given the s afety profile of IMM-124E, Immuron is not expecting any substantive issues to be raised by the hospitals’ respective ethics committees. Engagement of specialist diagnostic service provide rs to support the various assessments required in t he study such as MRI, pathology and immunological tests, have also been completed. Immuron is on track to complete by the end of this month production and packaging of a trial tablet formulation for IMM-124E. The Company can then dispatch the clinical trial product to the various hospitals as they receive their internal ethics approvals for the commencement of the trial. First patient recruitment is expected in before the end of the year as ethics approvals are granted. According to a recent report authored by Deutsche B ank, there are in excess of 25M NASH patients in th e US alone. There is no approved medicine for the treatment of NASH. Immuron intends that, following commencement of the NASH clinical trial, it will apply for Fast Track Designation of IMM-124E, for the treatment of NASH. FDA Fast Track Designation facilitates the development, and expedites the review, of drugs which treat a serious or life-threatening condition an d fill an unmet medical need. Page 2 of 2 The ASH Trial Immuron’s Phase II ASH trial is funded by the Unite d States National Institutes of Health (NIH). Notab ly, IMM-142E is one of only three candidates selected b y the NIH for study in patients with ASH from 27 dr ug candidates. The sites for the ASH trial are the Vir ginia Commonwealth University, Indiana University a nd the Mayo Clinic and each of these sites are sponsoring the trial and will manage it. Sixty-six ASH patients are expected to be recruited for the study, each of which will be randomly allo cated into one of three cohorts: 22 patients will receive a daily dose of 2,400mg, 22 patients will receive a daily dose of 4,800mg and 22 patients will receive the placebo. Since the treatment of ASH patients with Immuron’s IMM-124E is based on the same mechanism of action underlying Immuron’s NASH trial, the ASH trial is e xpected to add to Immuron’s body of knowledge relating to its IMM-124E and the treatment of chronic inflammation-driven liver diseases. Immuron has completed production of the trial product for ASH (this is separate from the production of the NASH clinical trial product) and is awaiting a Unit ed States import permit, which is expected later th is month. Once received, the ASH trial will be able to commence. Contacts: Amos Meltzer Chief Executive Officer +61 (0)437 587 680 Investor Relations Amanda Loh, Buchan Consulting +61 (0)3 9866 4722 Websites: www.immuron.com and www.travelan.com About Immuron Immuron (ASX:IMC) is a Melbourne based biopharmaceu tical company focused on the development of oral immunotherapy treatments using dairy-derived antibo dy products. Immuron has a unique technology platfo rm producing products all with a very high safety prof ile. Immuron sells Travelan ®, the world’s first effective over-the- counter preventative for travellers’ diarrhoea, currently available in Australia and Canada. Immuron i s progressing two Phase II trials for IMM-124E, for the treatment of inflamed fatty liver diseases and preclinical trial s for IMM-529 for the treatment of Clostridium difficile infection due to the overuse of antibiotics. Immur on’s main scientific alliances are with Hadassah Medical Center (Israel) and Monash University (Australia). About IMM-124E and NASH Non-Alcoholic Steatohepatitis (NASH) refers to a sp ectrum of conditions of the liver all of which invo lve chronic inflammation of the liver and is highly correlated with obesity, diabetes and high cholesterol. If lef t untreated NASH may lead over time to fibrosis and then cirrhosis o f the liver and severe liver dysfunction. NASH is i ncreasingly a cause of liver cancer and the need for a liver transplant . Immuron’s Phase II trial for IMM-124E is well pos itioned to leverage this large and growing market with currently no available drug available on the market. About IMM-124E and ASH Alcoholic Steatohepatitis (ASH) refers to inflamed fatty liver disease caused by excessive alcohol con sumption. Immuron is funded by the US National Institutes of Health (NIH) for the development of its IMM-124E Ph ase II trial for ASH. Notably, the NIH has chosen to fund IMM-124E a s one of three potential treatments for ASH chosen from 27 potential treatments.

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