Full Press Release Details
| Name of entity: | Immuron Limited |
| ABN: | 80 063 114 045 |
| Half-year ended: | 31 December 2018 |
| Previous period: | 31 December 2017 |
for announcement to the market
| $ | ||||||||||||||||
| Revenue for ordinary activities | Up | 6.4 | % | to | 978,233 | |||||||||||
| Net loss after tax (from ordinary activities) for the period attributable to members | Down | 16.4 | % | to | (1,581,899 | ) | ||||||||||
| Net loss after tax for the period attributable to members | Down | 16.4 | % | to | (1,581,899 | ) |
tangible assets per security
| 31 December | 31 December | |
| 2018 | 2017 | |
| Cents | Cents | |
| Net tangible asset backing (per share) | 5.01 | 3.85 |
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 2018.
information required by Listing Rule 4.2A
| a. Details of individual and total dividends or distributions and dividend or distribution payments: | N/A |
| b. Details of any dividend or distribution reinvestment plans: | N/A |
| c. Details of associates and joint venture entities: | N/A |
| d. Other information | N/A |
financial statements have been reviewed by the Company's independent auditor without any modified opinion, disclaimer or
emphasis of matters.
Limited ABN 80 063 114 045
financial report - 31 December 2018
| Page | |
| Corporate directory | 1 |
| Financial statements | |
| Directors' report | 3 |
| Directors | 3 |
| Review of operations | 3 |
| Auditor's independence declaration | 6 |
| Condensed consolidated statement of comprehensive income | 8 |
| Condensed consolidated balance sheet | 9 |
| Condensed consolidated statement of changes in equity | 10 |
| Condensed consolidated statement of cash flows | 11 |
| Notes to the condensed consolidated financial statements | 12 |
| Directors' declaration | 20 |
| Independent auditor's report to the members | 21 |
interim financial report does not include all the notes of the type normally included in an annual financial report. Accordingly,
this report is to be read in conjunction with the annual report for the year ended 30 June 2018 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 | |
| Mr. Richard Berman (appointed 1 July 2018) | |
| Independent non-executive director | |
| Secretary | Mr. Phillip Hains |
| Chief Executive Officer | Dr. Gary S Jacob (appointed 16 November 2018) |
| Registered Office | Level 3, 62 Lygon Street |
| Carlton VIC 3053 | |
| Australia | |
| Telephone: +61(0)3 9824 5254 | |
| Facsimile: +61(0)3 9824 5254 | |
| 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 - United States | Bank of New York |
| 225 Liberty Street | |
| New York, NY 102286 | |
| United States of America | |
| Telephone: +1 212 495 1784 | |
| Share Registry - Australia | Security Transfer Registrars Pty Ltd |
| 770 Canning Highway | |
| Applecross WA 6153 | |
| Australia | |
| Telephone: +61 (0)8 9315 2333 | |
| Facsimile: +61 (08) 9315 2233 | |
| Auditor - Australia and United States | Grant Thornton Audit Pty Ltd |
| Collins Square, Tower 5 727 Collins Street | |
| Melbourne VIC 3008 | |
| Australia | |
| Telephone: +61 (0)3 8320 2222 | |
| Solicitors - Australia | Francis Abourizk Lightowlers (FAL) |
| Level 14, 114 William Street | |
| Melbourne VIC 3000 | |
| Australia | |
| Telephone: +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 | |
| Sheppard Mullin | |
| 30 Rockefeller Plaza | |
| New York NY 10112-0015 | |
| United States of America | |
| Telephone: +1 212 653 8700 | |
| 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.au |
| www.travelan.com.au |
Directors present their report on the consolidated entity consisting of Immuron Limited and the entities it controlled at the
end of, or during, the half-year ended 31 December 2018.
following persons held office as Directors of Immuron Limited during the financial period:
Richard Berman (appointed 1 July 2018)
York New York - New Board Member and New Chief Executive Officer
York based Mr. Richard Jay Berman joined the Immuron Board in July 2018. Richard brings with him over 35 years of venture capital,
senior management and merger & acquisition experience. Dr. Gary Jacob also New York based was appointed Chief Executive Officer
in November 2018. Dr. Jacob's is the former Co-founder, Chairman, President and Chief Executive Officer of Synergy Pharmaceuticals
Inc. a Nasdaq-listed public biopharmaceutical company.
enjoys continued sales growth
flag-ship product Travelan , an over-the-counter travelers' diarrhoea supplement, experienced steady sales growth in
both Australian and U.S. markets throughout the first half of FY2019, with global gross sales reaching AU$1.083 million during
the 6-month period. In the US, Travelan sales grew by 10% to AU$369,000 in FY19 1H, as the brand continued to prosper via
USA's largest travel medicine provider, Passport Health. Growth of online sales on Amazon USA also contributed to this increase
following a successful promotional campaign in December.
Australia, Immuron sales reached AU$714,000 for 1H FY2019, with a 6% YoY growth rate. Travelan continues to experience strong
sales within Australia's pharmacy network. A concerted marketing push to educate GPs and consumers about Travelan will
continue into 2H FY2019, including a program to improve the brand's online footprint through a new global website and increased
collaborations with the travel blogger community.
of operations (continued)
enjoys continued sales growth (continued)
Canada Ltd was incorporated under the Canadian Business Corporations Act in April 2018. The associated Natural Product Number
for Travelan was officially transferred from former distributor Paladin Labs to Immuron Canada Limited in June 2018. A Distribution
and Sales Agreement was executed with ANB Canada Inc in October 2018. The company this year announced that Health Canada has approved
the product licence for Travelan , paving the way to re-launch the product within Canada in April 2019. ANB Canada will manage
the distribution and marketing of Travelan within the Retail Pharmacy sector, whilst Passport Health will sell the product
through their Canadian Travel Medicine Clinic network.
studies by US Department of Defense
provided an update on its cooperative research and development agreements with the US Department of Defense (US DoD) in July,
which included three studies on Travelan , the company's commercially available flagship over-the-counter gastrointestinal
and digestive health supplement. The studies aim to determine Travelan's effectiveness in neutralizing pathogenic gastrointestinal
bacterial infections as a preventative treatment for US military personnel stationed in locations where such infections may be
work completed at the US Armed Forces Research Institute of Medical Sciences, US Naval Medical Research Center and the Walter
Reed Army Institute of Research (WRAIR) found Travelan was effective across all strains and species of enteropathogenic bacteria
tested. The specificity of antibodies incorporated into Travelan cross-react with multiple Campylobacter, ETEC and Shigella strains.
The product is truly cross-reactive indicating a substantially broader spectrum of antimicrobial action than previously reported.
preventative treatment that protects against enteric diseases, specifically Shigella, is a high priority objective for the US
Army. Shigella is estimated to cause 80 -165 million cases of disease worldwide, resulting in 600,000 deaths annually and is particularly
prevalent in both sub-Saharan Africa and South Asia.
September 2018 we reported the findings of a study conducted by The US Armed Forces Research Institute of Medical Sciences (AFRIMS),
an overseas laboratory of the Walter Reed Army Institute of Research (WRAIR), located in Bangkok, Thailand. The study evaluated
the therapeutic potential of Travelan in a non-human primate (NHP) preclinical Shigella challenge model that closely mimics
the disease seen in humans. The study was performed in collaboration with the Department of Enteric Diseases and the Department
of Veterinary Medicine, AFRIMS, and the Department of Enteric Infections, Bacterial Diseases Branch, WRAIR.
reported in September, Travelan prevented clinical shigellosis (bacillary dysentery) in 75% of Travelan treated NHPs
compared to placebo. A placebo-controlled study was carried out in 12 NHPs segregated into two groups: a Travelan treatment
cohort of 8 and a placebo cohort of 4, which were treated with either Travelan or placebo respectively twice daily for a
total of 12 doses over a 6-day period. The animals received treatment for 3-days prior to oral challenge with ~3 x 109 viable
Shigella flexneri strain 2a organisms. All (4 of 4 - 100%) placebo-treated animals displayed acute dysentery symptoms within 24
- 36 hours of Shigella flexneri 2a challenge. A single (1 of 8 - 12.5%) of the Travelan -treated cohort displayed dysentery
symptoms at this time point. The remaining individuals (7 of 8 - 87.5%) in the Travelan treatment cohort remained symptom-free
to 4-days post Shigella flexneri 2a challenge. Once the treatment period concluded, a second individual in the Travelan treatment
group developed symptoms (2 of 8 - 25%). The remainder (6 of 8 - 75%) of the Travelan treated cohort remained symptom-free
to the conclusion of the study 11-days post Shigella flexneri 2a challenge.
of operations (continued)
specific therapeutics
July, Immuron announced it had once again engaged the services and facilities of the Commonwealth Scientific & Industrial
Research Organisation (CSIRO) to produce three Shigella specific therapeutic products utilizing vaccines developed by the Walter
Reed Army Institute of Research (WRAIR). Immuron received approval from Biosecurity Australia earlier last year to import the
Shigella specific vaccines developed and produced by the WRAIR which were used to manufacture the products. The vaccination program
was initiated in August last year and was completed in November. The hyperimmune colostrum from the study was harvested in December
and the freeze-dried finished products should be available in Q1 CY2019 for shipment to the WRAIR for preclinical assessment.
Under the current terms of the Cooperative Research Agreement, the WRAIR will fund the evaluation of the anti-Shigella therapeutics
and assess their protective capacity in a head to head comparison with Travelan in established small animal models.
Liver Clinical Update
results of our IMM-124E phase II Non-Alcoholic Steatohepatitis (NASH) clinical trial were reported in March 2018. Trial data demonstrated
a significant reduction in serum lipopolysaccharide (LPS), as well as reductions in other biomarkers associated with liver damage.
The company is presently focused on completing the final clinical study report, and is currently working with our contract research
organization partners to complete final analysis of data generated, and any additional tests performed. The final clinical study
report is expected to be completed early this year.
trial findings from the NASH trial were presented by Professor Arun Sanyal at the American Association for the study of Liver
Disease which was held in San Francisco, California during the 9th - 13th of November 2018. The presentation entitled "IMM-124E
Improves Metabolic Endotoxemia and Markers of Liver Injury in Non-Alcoholic Steatohepatitis" was presented during the Novel
Therapeutics for NASH session. A copy of the final presentation is available on the company website.
Arun Sanyal is also lead Principal Investigator of our alcoholic steatohepatitis ("ASH") clinical trial at Virginia
Commonwealth University. The overall trial, funded by the NIH, has successfully recruited a total of 56 patients which have been
randomized into the study. The trial is now closed to recruitment and the last patient last visit was completed in December 2018.
Top-line results are expected to be reported in Q2 2019.