Immuron Expands on Preliminary Success

Immuron Expands on Preliminary Success

Phase II Study in NASH Treatment with

Australia, 13 July 2017: Australian biopharmaceutical company, Immuron Limited (ASX:IMC; NASDAQ:IMRN), is pleased to expand

on the preliminary announcement of the interim analysis results recently reported from the IMM-124E Phase II study in NASH (ASX

Announcement, 10 July 2017).

aim is to illustrate that IMM-124E has the potential to play a differentiated role in the management of NASH which may form the

cornerstone of NASH combination treatment strategies, both as a single agent treatment and in combination with other agents.

the results of the study, Immuron's Head of Medical, Dr Dan Peres, MD said:

study results so far have been extremely encouraging for us as IMM-124E is demonstrating the expected safety and data to show it's

potential to treat NASH as a non-absorbable drug. We expect the remaing data coming in through until the end of the year will demonstrate

additional pathways making IMM-124E a strong candidate for the treatment of NASH either on its own, or in combination with other

objective of the interim analysis was to evaluate the safety of the product, and search for signals of efficacy from the primary,

secondary and exploratory endpoints at two dosage levels of IMM-124E under evaluation when compare with a placebo. As expected

there were no indications of safety concerns or adverse events, serum biochemistry, hematology, vital signs, or physical examination

findings for both treatment groups.

As previously reported, the interim analysis succeeded

in meeting its primary goals,safety and tolerability, and accordingly the Company's Medical Advisory Committee reviewing

the interim analysis results determined the study should proceed to completion as planned.

The higher evaluated

dose of IMM-124E was well tolerated with a significant safety margin to allow the evaluation of even higher doses in the future

evaluated were liver fat (using MRI compared with placebo), Liver enzymes (focusing on ALT), Hemoglobin A1c, metabolic markers,

immunological markers, serum bovine Ig (pharmacokinetics), and serum LPS levels.

be included in the interim analysis, patients needed to have attended at least one post-baseline visit. The Full Analysis Set (FAS

population) had 122 patients who met this criterion. To be included in the Per Protocol (PP population), patients had to have completed

the entire 24-week treatment period, have valid Baseline and Week 24 MRI values prior to 28 February 2017 for hepatic fat fraction,

be 80% - 120% compliant with study treatment and not have any major protocol deviations. A total of 69 patients met these criteria.

Due to the small cohort of participants included in the analysis no significance was expected to be reported at this early stage.

is very pleased to be able to report the efficacy signals on liver enzymes (ALT and AST) which demonstrated a dose related reduction

in both treatment doses at 24 weeks, though not significantly different than placebo.

wax and wane of these parameters over time and the significant affect of the baseline values led us to run the AUC analysis to

account for all data contrary to only 2 time points. Such analysis translated into a near-significant reduction of these parameters

over time (AUC ANCOVA analysis). Additional modeling emphasized this effect further to the point of statistical significance.

treatment effect trend was reported in both treatment groups compared to placebo. The greatest decrease occurred in the highest

dose group, with the low dose group decreasing by an intermediate amount compared with the placebo group.

believes that this documented effect within the entire study population, together with the established correlation of both liver

enzymes, with liver injury, is the proof of concept for a biological effect demonstrating decrease in liver injury by IMM-124E.

failure to meet a signal on Fat Fraction was not surprising due to the wide range of results reported across the participant cohort

analyzed, where readings ranged from 2% FF up to 40% FF. The interim analysis was not powered to achieve a statistical end point

on track to complete the NASH clinical trial for all remaining active study participants in order to report top line trial results

for the entire study by the end of 2017.

endpoints as outlined in the study protocol include mean serum concentrations of: lipopolysaccharide (LPS), C-reactive protein

(CRP), cytokeratin (CK)-18 fragments, C-peptide , glucagon-like peptide (GLP)-1 and adiponectin and subsets of inflammatory cytokines:

interleukin (IL)-6, IL-1 , IL1 , IL-2, IL-4 IL-10, IL-13, IL-12, IL-17, IL-23 interferon gamma (IFN ), Transforming

Growth Factor Beta (TGF- ) and tumor necrosis factor alpha (TNF ); These parameters are currently being analyzed by

our contract research organizations and we hope to have the final interim report compiled by the end of August 2017.

(NASDAQ: IMRN; ASX: IMC), is a biopharmaceutical company focused on developing and commercialising oral immunotherapeutics for

the treatment of gut mediated diseases. Immuron has a unique and safe technology platform that enables a shorter development therapeutic

cycle. The Company currently markets and sells Travelan for the prevention of Travellers' Diarrhea and its lead clinical

candidate, IMM-124E, is in Phase 2 clinical trials for NASH, ASH and Pediatric NAFLD. Immuron's second clinical stage asset,

IMM-529, is targeting C. difficile Infections (CDI). These products together with the Company's other preclinical

immunotherapy pipeline products targeting immune-related diseases currently under development, will meet a large unmet need in

the global immunotherapy market.

For more information

visit: http://www.immuron.com

About the IMM-124E Study

study is a Phase 2 proof of concept multinational, randomized, double-blind study comparing 2 doses IMM-124E to placebo for the

treatment of NASH in adults with any stage biopsy-proven NASH. The trial enrolled 133 patients and is still on going. The primary

endpoint is the improvement of liver steatosis as assessed by MRI comparing the mean values), as measured at the 24 weeks' time

point. The key secondary endpoints are: change in ALT as well as other liver enzymes and metabolic markers.

adults with all-stage biopsy proven NASH up to 12 months of randomization.

an oral, three-times-daily, non-absorbable compound containing poly-clonal anti-LPS immunoglobulins proposed to interact with the

gut LPS and immune system to achieve an immunomodulatory effect reducing LPS-related inflammation and inducing tolerance. Because

of this unique mechanism of action, targeting multiple pathways, IMM-124E has the potential to play a differentiated role in the

management of NASH and may form the cornerstone of NASH combination treatment strategies, both as a single agent and in combination

to the adult NASH study, IMM-124E is also being evaluated in the pediatric population in a Phase 2 proof-of-concept study of IMM-124E

in children with Pediatric NAFLD.

About Non-Alcoholic Steatohepatitis

type of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other

apparent causes. NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage. The inflammation

can lead to fibrosis (scarring) of the liver and eventually progress to cirrhosis, portal hypertension, liver cancer, and eventual

NASH is an emerging health crisis impacting

3% to 5% of the U.S. population and 2% to 4% globally, and is the fastest growing cause of liver cancer and liver transplant in

the U.S. The increasing prevalence of NASH is attributed to the growing obesity epidemic and the disease is often diagnosed in

patients who have diabetes, high cholesterol or high triglycerides. There is currently no approved treatment for NASH.

FORWARD-LOOKING STATEMENTS:

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results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain,

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