Full Press Release Details
| Name of entity: | Immuron Limited |
| ABN: | 80 063 114 045 |
| Year ended: | 30 June 2019 |
| Previous period: | 30 June 2018 |
| Results for announcement to the market | ||||
| $ | ||||
| Revenue from ordinary activities | Up | 29.5% | to | 2,387,426 |
| Loss from ordinary activities after tax attributable to members | Up | 53.9% | to | (4,632,743) |
| Net loss for the period attributable to members | Up | 53.9% | to | (4,632,743) |
| Distributions |
No dividends have been paid or declared by the
company for the current financial year. No dividends were paid for the previous financial year.
Explanation of results
Please refer to the review of operations and activities
on pages 3 to 6 for explanation of the results.
Additional information supporting the Appendix
4E disclosure requirements can be found in the review of operations and activities, directors' report and the financial statements
for the year ended 30 June 2019.
Net tangible assets per security
| 2019 | 2018 | |||||||
| Cents | Cents | |||||||
| Net tangible asset backing (per security) | 4.50 | 5.91 |
Changes in controlled entities
There have been no changes in controlled entities
during the year ended 30 June 2019.
Other information required by Listing Rule 4.3A
| 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 |
statements have been audited by the group's independent auditor without any modified opinion, disclaimer or emphasis of
report - 30 June 2019
| Corporate directory | 1 |
| Review of operations and activities | 3 |
| Directors' report | 7 |
| Directors and company secretary | 8 |
| Principal activities | 8 |
| Dividends - Immuron Limited | 8 |
| Review of operations | 8 |
| Significant changes in the state of affairs | 8 |
| Events since the end of the financial year | 8 |
| Likely developments and expected results of operations | 9 |
| Environmental regulation | 9 |
| Information on directors | 9 |
| Company secretary | 14 |
| Meetings of directors | 15 |
| Remuneration report (audited) | 16 |
| Shares under option | 24 |
| Insurance of officers and indemnities | 24 |
| Proceedings on behalf of the company | 25 |
| Non-audit services | 25 |
| Auditor's independence declaration | 25 |
| Rounding of amounts | 25 |
| Corporate governance statement | 27 |
| Financial statements | 29 |
| Independent auditor's report to the members | 71 |
| Shareholder information | 76 |
| Directors | Dr Roger Aston |
| Independent Non-Executive Chairman | |
| Mr Peter Anastasiou Executive Vice Chairman | |
| Dr Gary Jacob (appointed 17 April 2019) | |
| Executive Director and Chief Executive Officer | |
| 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 |
| 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 register | Security Transfer Registrars Pty Ltd |
| 770 Canning Highway Applecross WA 6153 Australia | |
| Telephone: +61 (0)8 9315 2333 | |
| Bank of New York | |
| 225 Liberty Street | |
| New York NY 102286 | |
| United States | |
| Telephone: +1 212 495 1784 | |
| Auditor | Grant Thornton Audit Pty Ltd |
| Collins Square | |
| Tower 5, 727 Collins Street | |
| Melbourne VIC 3008 | |
| Australia | |
| Telephone: +61 (0)3 8320 2222 |
| Solicitors | Francis Abourizk Lightowlers (FAL) |
| Level 14, 144 William Street Melbourne VIC 3000 | |
| Australia | |
| Telephone: +61 (0)3 9642 2252 | |
| Carter Ledyard & Milburn LLP | |
| 2 Wall Street | |
| New York NY 10005 | |
| United States | |
| Telephone: +1 212 238 8605 | |
| Sheppard Mullin | |
| 30 Rockefeller Plaza | |
| New York NY 10112 | |
| United States | |
| Telephone: +1 212 653 8700 | |
| Bankers | National Australia Bank (NAB) |
| 330 Collins Street Melbourne VIC 3000 Australia | |
| Stock exchange listings | Immuron Limited shares are listed on the Australian Securities Exchange (ASX: IMC) and NASDAQ (IMRN) |
| Website | www.immuron.com.au |
Review of operations and activities
Immuron Limited has reported a loss for the year ended 30 June
2019 of $4,632,743 (2018: $3,010,929). The group's net assets decreased to $7,351,136 compared with $8,439,350 at 30 June
2018, including cash reserves of $5,119,887 (2018: $4,727,430).
Travelan sales surge in all markets
Global sales of Travelan, Immuron's over-the-counter gastrointestinal
and digestive health supplement, increased by 29.5% year-on-year in the 2019 financial year, achieving $2.39 million total sales.
Australian sales revenue recorded $1.22 million, showing continued
growth and a 14% increase against FY 2018. Increased initiatives in the pharmacy sector, including television advertising with
Chemist Warehouse and stronger merchandising in-store, contributed to this sales momentum.
In the United States, Travelan sales also spiked dramatically
with FY 2019 revenue exceeding the $1 million milestone for the first time, as sales grew strongly by 32% year-on-year to $1.02
million thanks to the partnership with Passport Health, America's largest travel medicine network, and rising sales on the
Amazon platform. During FY 2019, Immuron featured on two podcasts on the Not Old, Better' channel in the United States.
This included an interview with Dr Hailey Weerts from the U.S. Department of Defense, in which she spoke of the ground-breaking
research into Travelan by the Walter Reed Army Institute of Research (WRAIR). Both podcasts resulted in an immediate spike in sales
of Travelan on Amazon, with this online category growing by almost 80% in FY 2019. May 2019 also represented a record-breaking
month for Travelan sales with revenue climbing to $182k in the United States.
April saw the official relaunch of Travelan in Canada, with
ANB Canada managing marketing and distribution in the retail pharmacy sector. The major Canadian pharmacy chain Shoppers Drug Mart
was the first banner to range the product. The growth underlines the attention Immuron pays to sales expansion in North America.
FDA registration for clinical development of IMM-124E/Travelan
to prevent travellers' diarrhea underway
In April 2019, we announced plans to pursue clinical development
of IMM-124E through a formal FDA registration pathway as a drug to prevent travellers' diarrhea (TD). This is an important
strategic initiative towards enhancing commercialisation of the Travelan/IMM-124E franchise. Because Travelan and IMM-124E are
one and the same, the group believes seeking FDA registration for IMM-124E as a drug to prevent travellers' diarrhea offers
the potential for substantial sales benefits. We are moving aggressively forward to develop IMM-124E through the FDA, and in August
2019 we filed with FDA a request for a Type B meeting with the agency, with a submitted Investigational New Drug (IND) application
(IND#145362), to discuss the clinical development plan for IMM-124E to prevent travellers' diarrhea. We believe that a successful
clinical program, followed by a BLA filing with the Agency, and successful FDA approval of IMM-124E to specifically prevent travellers'
diarrhea could lead to substantial increases in the marketing of an approved drug to treat travellers' diarrhea. Travellers'
diarrhea affects between 30 and 60% of more than a billion international travellers a year. With FDA approval as a preventive drug
for travellers' diarrhea we predict a potential sales peak at more than US$100 million.
Two additional clinical studies have been performed with IMM-124E:
1) a Phase II clinical study in patients with severe alcoholic hepatitis (SAH) conducted under FDA IND #015675 funded by the National
Institute of Alcohol Abuse and Alcoholism (NIAAA), and 2) a second NIH funded Phase II clinical study in paediatric patients with
non-alcoholic fatty liver disease (NAFLD) conducted under FDA IND #017066.
Top-line results from the SAH trial with Dr Arun Sanyal of Virginia
Commonwealth University as the lead Principal Investigator were released in August 2019. The primary objective of this study was
to evaluate the safety and efficacy of IMM-124E at two oral dosage levels as compared with a placebo in patients with severe alcoholic
hepatitis and with all patients being treated with steroids. A total of 57 patients with SAH with a model for end stage liver disease
(MELD) score ranging from 21-28 were enrolled into the clinical study and were treated with either IMM-124E or placebo for 28 days
(placebo N=20, IMM-124E 2400 mg/day N=18, IMM-124E 4800 mg/day N=19). No suspected unexpected serious adverse reactions (SUSAR)
were reported and no differences in serious adverse events (SAE) were observed across the three arms of the study and no SAE was
considered related to the study drug by investigators. Both doses of IMM-124E in the study (2400 mg and 4800 mg) were well tolerated.
There were nine deaths reported over a six-month period for the entire cohort and there were no significant differences across
study groups. The data showed that IMM-124E is safe to use in patients with SAH but does not reduce circulating lipopolysaccharide
levels, mortality or have an impact on MELD score in the study population, and we will not continue clinical development of IMM-124E
specifically to treat SAH.
The safety data generated from the 57 SAH patients along with
the data generated in the 24-week treatment study of IMM-124E in non-alcoholic steatohepatitis (NASH) under FDA IND #014933 which
involved 133 patients has been summarised and submitted to the FDA to support the registration strategy and the clinical development
plan for IMM-124E to prevent travellers' diarrhea.
The NIH-funded Phase II double-blind, placebo-controlled, randomised
clinical trial of IMM-124E in paediatric non-alcoholic fatty liver disease (NAFLD) patients is presently underway at Emory University,
led by Dr Miriam Vos, who specialises in the treatment of gastrointestinal disease in children, including NAFLD and obesity. The
trial has presently randomised 24 of the targeted 40 patients into the study. The top-line results for this study are anticipated
to be reported next year.
IMM-529 C. difficile infection update
In March 2019, we provided an update regarding the status of
the IMM-529 clinical trial in patients with CDI, along with a refocusing of our efforts to develop IMM-529. The Phase I/IIa clinical
trial of IMM-529 in patients with C. difficile initiated at the end of 2017 at two clinics in Israel, had not enrolled patients'
numbers anticipated for those sites. To date, only nine out of 60 patients have been randomised into the study and the group has
decided to close these sites and to focus further development of IMM-529 to treat CDI patients through a formal filing of an IND
with FDA, and to focus development of the drug candidate specifically to treat patients with recurrent disease, a major unmet medical
need in treatment of patients suffering with C. difficile infections. We are planning to file a Type B meeting request with
FDA to explore further development of IMM-529 in treating patients with CDI. We anticipate having this meeting during 1H2020.
U.S. Clostridium difficile patent granted
In March 2019, the United States Patent and Trademark Office
issued a patent for a method to treat Clostridium difficile with IMM-529. C. difficile remains a major medical problem globally
creating a yearly economic burden estimated at US$10 billion and killing 28,000 Americans alone. It presents as a serious and constant
problem in hospitals and long-term in-patient care facilities.
U.S. Department of Defense's Travelan Shigellosis
animal study results reported
In June 2019, we updated the market on the latest developments
arising from our cooperative research and development efforts with the United States Department of Defense.
The R&D initiatives focus on Shigella research. Shigella