Immuron Ltd — Regulatory Filings 2014

Oct 14, 2014

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Final Preparations Underway for Commencement of ASH and NASH Clinical Trials

Melbourne, Australia - 15 October 2014: Australian biopharmaceutical company Immuron Limited (ASX: IMC) is nearing initiation of two separate clinical trials with final preparations underway for non-alcoholic 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 expected to be initiated before the end of the year as previously advised. Both trials are designed as placebo-controlled, double-blinded and dose ranging multicentre 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 preparations. Immuron is funding the Phase II trial in 120 NASH patients all of whom will be treated for six months with IMM-124E.

In support of commencing the trials, the Company has engaged the services of data management and clinical monitors. The monitors’ first task is to ensure that participating hospitals have a pool of relevant patients and are equipped to carry out the trial. Immuron’s appointed monitors have already assessed and approved the Company’s selected hospitals in Australia and the United States. Hospital ethics submissions are underway with the first ethics approval expected later this month. Each hospital is required to obtain ethics clearance from its internal ethics committee, the principal purpose of which is to ensure the trial does not unduly place patients at risk. Given the safety 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 providers to support the various assessments required in the 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 Bank, there are in excess of 25M NASH patients in the 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 and fill an unmet medical need.

Suite 1, 1233 High Street Armadale, Victoria AUSTRALIA 3143

www.immuron.com

Phone: + 61 (0)3 9824 5254 Facsimile: + 61 (0)3 9822 7735

ABN: 80 063 114 045

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The ASH Trial

Immuron’s Phase II ASH trial is funded by the United States National Institutes of Health (NIH). Notably, IMM-142E is one of only three candidates selected by the NIH for study in patients with ASH from 27 drug candidates. The sites for the ASH trial are the Virginia Commonwealth University, Indiana University and 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 allocated 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 expected 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 United States import permit, which is expected later this month. Once received, the ASH trial will be able to commence.

Contacts:

Amos Meltzer Investor Relations Chief Executive Officer Amanda Loh, Buchan Consulting +61 (0)437 587 680 +61 (0)3 9866 4722

Websites: www.immuron.com and www.travelan.com

About Immuron

Immuron (ASX:IMC) is a Melbourne based biopharmaceutical company focused on the development of oral immunotherapy treatments using dairy-derived antibody products. Immuron has a unique technology platform producing products all with a very high safety profile. Immuron sells Travelan®, the world’s first effective over-thecounter preventative for travellers’ diarrhoea, currently available in Australia and Canada. Immuron is progressing two Phase II trials for IMM-124E, for the treatment of inflamed fatty liver diseases and preclinical trials for IMM-529 for the treatment of Clostridium difficile infection due to the overuse of antibiotics. Immuron’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 spectrum of conditions of the liver all of which involve chronic inflammation of the liver and is highly correlated with obesity, diabetes and high cholesterol. If left untreated NASH may lead over time to fibrosis and then cirrhosis of the liver and severe liver dysfunction. NASH is increasingly a cause of liver cancer and the need for a liver transplant. Immuron’s Phase II trial for IMM-124E is well positioned 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 consumption. Immuron is funded by the US National Institutes of Health (NIH) for the development of its IMM-124E Phase II trial for ASH. Notably, the NIH has chosen to fund IMM-124E as one of three potential treatments for ASH chosen from 27 potential treatments.

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