Full Press Release Details
Ended 31 December 2017
| Name of Entity: | Immuron Limited |
| ABN: | 80 063 114 045 |
| Half-Year Ended: | 31 December 2017 |
| Previous Period: | 31 December 2016 |
| Revenue for ordinary activities | Up | 30.7% | to | $919,138 |
| Net profit after tax (from ordinary activities) for the period attributable to members | Down | 44.5 % | to | ($1,891,944) |
| Net tangible assets per security | 31 December 2017 | 31 December 2016 |
| Net tangible asset backing (per share) | $3.85 | $3.36 |
explanation of the key financial elements contributing to the revenue and result above can be found in the Review of Operations
included within the Directors' Report.
dividends have been paid or declared by the Company for the current financial period. No dividends were paid for the previous
in Controlled Entities
have been no changes in controlled entities during the half-year 31 December 2017.
Information Required by Listing Rule 4.2A
interim financial statements have been reviewed by the Company's independent auditor with a material uncertainty related
the Half-Year Ended 31 December 2017
Financial Report - 31 December 2017
| Contents | Page |
| Corporate Directory | 1 |
| Directors' Report | 3 |
| Interim Financial Statements | |
| Consolidated Statement of Comprehensive Income | 8 |
| Consolidated Balance Sheet | 9 |
| Consolidated Statement of Changes in Equity | 10 |
| Consolidated Statement of Cash Flows | 11 |
| Notes to the Consolidated Financial Statements | 12 |
| Directors' Declaration | 18 |
| Independent Auditor's Review Report to the Members | 19 |
interim financial report does not include all the notes of the type normally included in an annual financial report.
this report is to be read in conjunction with the annual report for the year ended 30 June 2017 and any public announcements made
by Immuron Limited during the interim reporting period in accordance with the continuous disclosure requirements of the Corporations
| Directors | Dr. Roger Aston |
| Independent non-executive chairman | |
| Mr. Peter Anastasiou | |
| Executive vice chairman | |
| Mr. Daniel Pollock | |
| Independent non-executive director | |
| Mr. Stephen Anastasiou | |
| Independent non-executive director | |
| Prof.Ravi Savarirayan | |
| Independent non-executive director | |
| Company Secretaries & Chief Financial Officers | Mr. Phillip Hains |
| Mr. Peter Vaughan | |
| Interim Chief Executive Officer | Dr. Jerry Kanellos |
| Registered Office | Level 3, 62 Lygon Street Carlton VIC 3053, |
| Australia | |
| Telephone: +61(0)3 9824 5254 | |
| Facsimile: +61(0)3 9822 7735 | |
| Principal Place of Business | Unit 10, 25 - 37 Chapman Street Blackburn |
| North VIC 3130 Australia | |
| Telephone: +61 (0)3 9824 5254 | |
| Facsimile: +61 (0)3 9822 7735 | |
| Share Registry - Australia | Security Transfer Registrars Pty |
| Ltd 770 Canning Highway | |
| Applecross WA 6153 Australia | |
| Telephone: +61 (0)8 9315 2333 | |
| Facsimile: +61 (0)8 9315 2233 | |
| Share registry - United States | Bank of New York 225 Liberty Street |
| New York, NY 102286 | |
| United States of America | |
| Telephone: +1 (0)212 495 1784 | |
| Auditor - Australia | Grant Thornton Audit Pty Ltd |
| Collins Square, Tower 1 727 Collins Street | |
| Melbourne VIC 3008 Australia | |
| +61 (0)3 8320 2222 | |
| Auditor - United States | Grant Thornton Audit Pty Ltd |
| Collins Square, Tower 1 727 Collins Street | |
| Melbourne VIC 3008 Australia | |
| +61 (0)3 8320 2222 | |
| Solicitors - Australia | Francis Abourizk Lightowlers |
| (FAL) Level 14 | |
| 114 William Street | |
| Melbourne VIC 3000 Australia | |
| +61 (0)3 9642 2252 | |
| Solicitors - United States | Carter Ledyard and Milburn |
| LLP 2 Wall Street | |
| New York NY 10005 | |
| United States of America | |
| Telephone: +1 212 238 8605 |
| Bankers | National Australia Bank (NAB) |
| 330 Collins Street | |
| Melbourne VIC 3000 | |
| Australia | |
| Securities exchange listings | Australian Securities Exchange (Code: IMC) |
| NASDAQ Exchange (Code: IMRN) | |
| Websites | www.Immuron.com |
| www.travelan.com.au | |
| www.travelanusa.com |
Directors present their report on the consolidated entity (referred to hereafter as the Company) consisting of Immuron Limited
and the entities it controlled at the end of, or during, the half-year 31 December 2017.
| The following persons held office as Directors of Immuron Limited during the financial period: | |
| Dr. Roger Aston | Non-Executive Chairman |
| Mr. Peter Anastasiou | Executive Vice-Chairman |
| Mr. Daniel Pollock | Non-Executive Director |
| Mr. Stephen Anastasiou | Non-Executive Director |
| Prof.Ravi Savarirayan | Non-Executive Director |
2018 for Pediatric NAFLD; and
Liver Portfolio - 3 x Phase II Programs in clinical development (NASH, ASH and Pediatric NAFLD)
completed its 133-patient Phase II NASH study in this reporting period. The last patient randomised into the study completed the
final scheduled clinical site visit in October and the study site conducted its Close-Out Visit, which represented the last on-site
monitoring visit for the study. This effectively concluded patient treatment and all research related activities at all clinical
sites for the IMM-124E NASH phase II study. All 25 clinical sites are now closed and Immuron is on track to report the top line
results in Q1 CY2018.
in the year the company reported the safety and efficacy results of a planned interim analysis. The objectives of the analysis
were to establish the safety of IMM-124E and to provide a preliminary read on efficacy signals. The study analysed 122 patients,
80 of whom completed their 24-week treatment with IMM-124E.
interim analysis showed:
results reported showed a dose related reduction which is proof of concept for a biological effect demonstrating treatment with
IMM-124E is associated with a reduction in liver injury in NASH patients.
giants Bristol-Myers Squibb and Pfizer have both signalled product development intentions in the sector. And Reuters has quoted
estimates that the NASH market will reach US$20 billion to US$35 billion as the incidence of fatty diets multiplies.
the same time the November approval of a US patent firmly underlines the strength of Immuron's position in the race to commercialise
IMM-124E as a world-leading treatment for non-alcoholic steatohepatitis (NASH).
is a severe form of non-alcoholic fatty liver disease (NAFLD). It affects about 16 million people annually in the United States
alone, making it a prime opportunity for the pharmaceutical and biotechnology industries.
17.3 percent of Americans aged 15 - 19 suffering NAFLD, Immuron's Phase II trial with Emory University is timely.
Health authorities estimate paediatric NAFLD affects five to 10 percent of the US paediatric population, with no current approved
lead Principle Investigator for our Paediatric NAFLD study is Dr Miriam Vos, Emory University. Dr Vos specializes in the
treatment of gastrointestinal disease in children as well as fatty liver disease and obesity. Our NIH funded Phase II double
blind, placebo control, randomized study on IMM-124E has enrolled 16 patients into the study as of February this year and has
so far randomized 40% of the targeted 40 patients into the study. The primary endpoint is changes in ALT (liver enzymes)
following 3 months of treatment with top-line results expected in Q4 2018.
Arun Sanyal is the lead Principle Investigator for the Immuron alcoholic steatohepatitis (ASH) clinical study which is also funded
by the NIH. Approximately 70% (46) of the targeted 66 patients have been randomized into the study. The primary endpoint is changes
in ALT (liver enzymes) and topline results are expected in Q1 2019.
moves forward to clinical study status in C. difficile infection
July, Immuron announced the publication of the results of its successful pre-clinical proof-of-concept (POC) program in Clostridium
difficile infection (CDI).
results from the Monash University study were presented in a peer-reviewed paper in Scientific Reports, an online, open
access journal from the publishers of Nature.
results were also presented at the 10th International Conference on the Molecular and Pathogenesis of the Clostridia
(ClostPath 10) in the United States in August.
August Israel's Ministry of Health and the Hadassah Medical Centre Human Research Ethics Committee approved the commencement
of the first in-human clinical trial. Immuron opened the first clinical site at the Hadassah Medical Centre in September and is
aiming to enrol a total of 60 CDI positive patients into the study.
IMM-529 is a first-in-class biologic containing highly specific antibodies to C. difficile. IMM-529's unique
triple-targeted mechanism of action (MOA) effectively neutralizes C. difficile without negatively affecting the
normal gut microbiota.
has a massive impact on human health, affecting more than 450,000 people annually and killing over 29,000 a year in the US alone.
Estimates of the economic burden of CDI exceed US$10 billion a year.
moves forward to clinical study status in C. difficile infection
is pursuing the biopharmaceutical research and development of an effective and safe non-antibiotic treatment for Clostridium
difficile infection (CDI). The phase I/II randomised, double-blind, placebo-controlled study is designed to evaluate the safety
and efficacy of the IMM-529 drug product candidate for the treatment of CDI.
July, Immuron announced the publication of the results of its successful pre-clinical proof-of-concept (POC) program in Clostridium
difficile infection (CDI). The results from the Monash University study were presented in a peer-reviewed paper in Scientific
Reports, an online, open access journal from the publishers of Nature.
results were also presented at the 10th International Conference on the Molecular and Pathogenesis of the Clostridia
(ClostPath 10) in the United States in August.
August Israel's Ministry of Health and the Hadassah Medical Centre Human Research Ethics Committee approved the commencement
of the first in-human clinical trial. Immuron opened the first clinical site at the Hadassah Medical Centre in September and a
second site was opened in January 2018 at the Sheba Medical Center at the Tel Hashomer Hospital. The first-in-human study is aiming
to enrol a total of 60 CDI positive patients into the study.
IMM-529 is a first-in-class biologic containing highly specific antibodies to C. difficile. IMM-529's unique
triple-targeted mechanism of action (MOA) effectively neutralizes C. difficile without negatively affecting the
normal gut microbiota.
has a massive impact on human health and according to data published by the US Centre for Disease Control and Prevention infects
more than 450,000 people annually and killing over 29,000 a year in the US alone. Estimates of the economic burden of CDI exceed
US$10 billion a year.
Travelan enjoys continued strong sales growth
flag-ship product Travelan , an over-the-counter travellers' diarrhoea supplement realised revenue of more than AU$914,000
for the first 6 months of the 2018 financial year. Travelan USA experienced a 250 percent increase in sales, year over year
reaching AU$335,000. Travelan Australia also reported strong growth with a 27 percent lift in turnover.
attributes the strong FY2018 first half performance to its trade marketing campaign made up of:
company is anticipating that the same sales trajectory will continue for the remainder of the 2018 financial year and sales are
forecast to exceed AU$2 million for the first time.
with the US Department of Defense
collaboration with the US Department of Defence advanced during this reporting period.
Entero-invasive Gram-negative bacteria are a global issue affecting travellers visiting and children living in endemic areas.
diarrhea is a World Health Organisation public health priority area due to a lack of effective vaccines and the accelerating global
antimicrobial resistance (AMR) crisis. In the absence of a licensed vaccine, an alternative, non-antibiotic prophylactic approach
would serve a definite role in mitigation of disease burden.
major study commissioned during this reporting period by the US Department of Defence (DoD) and funded by the Health Agency's
Defence Health Program was performed at the Department of Enteric Diseases (DED), Armed