Immuron Ltd — Regulatory Filings 2011

Aug 21, 2011

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IMMURON ON TRACK FOR PHASE 2B NASH TRIAL FOLLOWING POSITIVE MEETING WITH US FDA

 Immuron proceeding to IND submission for NASH life threatening liver disease  Phase 2B clinical trial confirmed

Melbourne, Australia, Monday 22 August 2011 : Australian biop h armaceutic a l company Im m uron [ASX:I M C] is proceeding with a n Investigati o nal New Dr u g (IND) sub m ission following a pr o ductive me e ting with th e US Food a n d Drug Ad m inistration ( F DA) for its d rug candida t e IM M -124E to tre a t Non-Alco h olic Steatohepatitis (NA S H).

Bas e d on this m e eting with t h e FDA and i n line with r e cent guidance, Immuro n is preparin g its Phase 2B proto c ol and expe c ts to submi t the full IND package to the FDA in t h e latter part of 201 1 . Subject t o the final su b mission being agreed b y the FDA, t h is will be fol l owed by co m mencement of the approved clinical t rial.

The trial is bein g designed b y Immuron i n conjunction with Dr Aru n Sanyal, Pr o fessor of Me d icine at Virg i nia Commo n wealth Uni v ersity, who w ill serve as t he principal investigator. The trial will be a do s e ranging pl a cebo contr o lled, double blinded mul t i-centre stu d y with sites in the U SA, Israel a nd Australi a . Enrolment is expected in the first h a lf of 2012.

Principal investi g ator for Im m uron’s Phase 2B trial, P r ofessor Aru n Sanyal sta t ed “It is enc o uraging to s ee that a pr o gram with early promise using a nov e l approach t o treating N A SH is t o be further i n vestigated t h rough a stringent phase 2B trial. I lo o k forward t o commencing this trial with the prospect of making Imm u ron’s NAS H therapeutic available to patients in nee d .”

Im m uron Chief E xecutive Mr Joe Baini s a id “This is a significant m ilestone for I mmuron an d mor e importantl y for the milli o ns of patie n ts suffering f rom NASH, as it remain s one of few l ife thre a tening dise a ses without an approve d treatment.”

Contact Joe Baini – Chief Executive O fficer Rudi Mi c helson +61 3 8637 110 7 Monsoon Communi c ations +61 3 9 6 20 3333 0411 4 0 2 737

About Immuron Limited

Im m uron is a bi o pharmaceutical compan y focused on oral immun o therapy usi n g dairy-deri v ed anti b ody produc t s for humans. Immuron is a uniquely positioned b iotechnolog y company w ith a ver s atile technology platform capable of g enerating a wide range o f products w ith a high s a fety profile. This hig h safety profile makes it p ossible to c o mplete pre- c linical studi e s relatively qui c kly and incr e ases the pr o spect that t h e clinical development of Immuron’s products will be exp e dited. Imm u ron’s curre n t products and product c andidates target infectio u s diseases o f the g astrointesti n al tract, chr o nic disease s such as fa t ty liver (NA S H), and the p revention of influenza. Imm u ron has one product in t h e market, T r avelan, for p reventing tr a vellers’ diar r hoea. Im m uron’s main scientific alliances are w i th Hadassa h Medical C e nter (Israel) and the Uni v ersities of M elbourne and Monash ( A ustralia).

About NASH

Non-alcoholic Steatohepatitis (NASH) is a chronic disorder of the liver, also known as fatty liver disease. It is associated with Type 2 diabetes, excessive amounts of fat in liver cells and abnormal liver function. NASH is more prevalent in the obese population and is an independent risk factor for the development of metabolic syndrome and cardiovascular complications. The increase in obesity worldwide is likely to raise the incidence of NASH with the associated outcomes of liver failure and cardiovascular disease. The United States National Centre for Infection Control has predicted that by 2025, 25 million Americans will suffer from NASH, with very few current treatment options. At present approximately 5% of Americans are affected, with similar rates in Australia.

Health systems around the world are already overburdened with the outcomes of metabolic syndrome such as obesity, liver disease, Type 2 diabetes and hyperlipidemia (excess lipids such as cholesterol in the blood stream).