Recent Updates
Recently added Catalysts
IMRN

Immuron Limited Appendix 4E 30 June 2020 Immuron Limited Appendix 4E Year ended 30 June 2020 Name of entity: Immuron Limited ABN: 80 063 114 045 Year ended: 30 June 2020 Previous period: 30 June 2019 Results for announce

Key Takeaway: Year ended 30 June 2020 Name of entity: Immuron Limited ABN: 80 063 114 045 Year ended: 30 June 2020 Previous period: 30 June 2019 Results for announcement to the market $ Revenue from ordinary activities Up 5.5 % to 2,518,566 Loss from ordinary activities aft

Full Press Release Details

Year ended 30 June 2020
Name of entity: Immuron Limited
ABN: 80 063 114 045
Year ended: 30 June 2020
Previous period: 30 June 2019
Results for announcement to the market
$
Revenue from ordinary activities Up 5.5 % to 2,518,566
Loss from ordinary activities after tax attributable to members Down (37.1 )% to (2,927,206 )
Net loss for the period attributable to members Down (37.1 )% to (2,927,206 )
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 4 to 7 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 2020.
Net tangible assets per security
2020 Cents 2019 Cents
Net tangible asset backing (per security) 3.17 4.50
Changes in controlled entities
There have been no changes in controlled
entities during the year ended 30 June 2020.
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
The financial statements have been audited by the group's independent
auditor without any modified opinion, disclaimer or emphasis of matter.
Audited financial report - 30
Corporate directory 1
Review of operations and activities 4
Directors' report 8
Directors and company secretary 9
Principal activities 9
Dividends - Immuron Limited 9
Review of operations 9
Significant changes in the state of affairs 9
Events since the end of the financial year 9
COVID-19 10
Likely developments and expected results of operations 10
Environmental regulation 10
Information on directors 10
Company secretary 14
Meetings of directors 15
Remuneration report (audited) 16
Shares under option 24
Insurance of officers and indemnities 25
Proceedings on behalf of the company 25
Non-audit services 25
Auditor's independence declaration 25
Rounding of amounts 25
Financial statements 28
Independent auditor's report to the members 76
Directors Dr Roger Aston
Independent Non-Executive Chairman
Mr Peter Anastasiou Executive Vice Chairman
Dr Gary Jacob (appointed 17 April 2019, resigned 25 March 2020)
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, resigned 17 October 2019)
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 Automic Pty Ltd
Level 5, 126 Phillip Street
Sydney Sydney 2000
Australia
Telephone: +61 (0)2 9698 5414
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
Sichenzia Ross Ference LLP
1185 Avenue of the America's
New York NY 10036
United States
Telephone: +1 212 930 9700
Bankers National Australia Bank
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 financial year ended 30 June 2020 of AUD $2,927,206 (30 June 2019: AUD $4,656,421). The group's net assets decreased
to AUD $5,643,913 compared with AUD $7,351,136 at 30 June 2019, including cash reserves of AUD $3,250,468 (30 June 2019: AUD $5,119,887).
American depository shares (ADS) capital raise completed
In July 2020, the company successfully
completed a US$20 million register direct offering of American Depository Shares (ADS). Immuron issued 1,006,668 ADSs, equivalent
to 40,266,720 fully paid ordinary shares at a purchase price of US$18.75 per ADS (equivalent to US$0.469 per share) for gross proceeds
of ~US$20 million. Each ADS represents forty (40) of the company's ordinary shares. The proceeds will go towards the pre-clinical
and clinical development of our therapeutic drug candidates, as well as for working capital. H.C. Wainwright and Co. acted as the
exclusive placement agent for the offering.
Immuron's IMM-124E used
to manufacture Travelan and Protectyn demonstrates antiviral activity against the COVID-19 virus in laboratory studies
Part of the proceeds of the July
2020 capital raise will be used to further develop the antiviral activity reported against the severe acute respiratory syndrome
coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. The company has been engaging with local, national, and international
potential research collaborators to advance this work and assist in the further characterization of the neutralization activity
of SARS-CoV-2 observed with our commercial hyper-immune colostrum. In July 2020 we announced the findings of 360 biolabs, a Melbourne
based Contract Research Organization using the SARS-CoV-2 hCoV-19/Australia/VIC01/2020 virus obtained from Melbourne's Peter
Doherty Institute for Infection and Immunity. The in-vitro assessment of the neutralization of SARS-CoV-2 was performed on four
production lots of product used to manufacture Travelan and Protectyn . The In-vitro susceptibility of the virus to IMM-124E
was determined using the quantitative assay which measures virus replication in the presence of increasing concentrations of the
product compared to replication in the absence of the product. The effective concentration of IMM-124E was reported as the concentration
of the product at which virus replication is inhibited by 50 percent (EC50) or 90 percent (EC90).
All four production lots produced
mean EC50 values of 40.5 to 91.9 ug/mL and inhibited viral replication at concentrations which there was no observed
cell toxicity. The concentration of IMM-124E at which virus replication was inhibited by 90 percent (EC90) produced
mean EC90 values ranging from 48.7 to 155.4 ug/mL for all four lots tested again at concentrations at which there was
no observed cell toxicity. A commercially available high protein milk powder product was used as a placebo in the studies and
produced EC50 values greater than the observed cellular cytotoxicity concentration of >4800 ug/mL. The control milk
powder inhibited viral replication at doses >25,000 ug/mL and more importantly did not inhibit viral replication at doses which
it was cytotoxic to cells. Another major finding made during the study was that cell viability in the presence of IMM-124E was
greatly enhanced when compared to placebo. IMM-124E improved cell viability by 180 to 260% relative to controls. These results
indicate that IMM-124E at concentrations which inhibited SARS-CoV-2 replication improved cell viability.
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
Sichenzia Ross Ference LLP
1185 Avenue of the America's
New York NY 10036
United States
Telephone: +1 212 930 9700
Bankers National Australia Bank
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
US Department of Defence relationships remain strong
For all the disruption caused by the COVID-19
pandemic, our partnerships with components of the US Department of Defence remain strong, close, and strategically vital. We will
continue the clinical development of a new oral therapeutic for traveller's diarrhoea in conjunction with the US Naval Medical
Research Centre. The initiative is in line with the more pressing demands the COVID-19 crisis has thrust upon international therapeutic
research. Strong progress has been made since the easing of COVID-19 restrictions in NSW. We have now completed the vaccination
campaign and will begin to harvest the colostrum in September this year. We are currently on track to manufacture the drug substance
and drug product by the end of this year as planned. The Naval Medical Research Center (NMRC) has received written guidance from
the U.S. Food and Drug administration (FDA) in relation to the clinical development pathway of the new drug which the company is
developing to treat moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections. The Type B meeting
with the FDA discussed the Chemistry, Manufacturing and Controls including the proposed release testing specifications of the product
as well as the planned clinical studies evaluating the safety and efficacy of the product. Work on the Investigational New Drug
application has been initiated.
COVID-19 pandemic impacts travel in all Travelan
The COVID-19 pandemic caused massive international
travel restrictions in mid to late March 2020, affecting every Travelan market which had a flow-on effect to Q4
FY20 Travelan sales due to the product's positioning as a Travellers' Diarrhoea preventative. Gross worldwide
sales of Travelan increased by 4% in the 2020 fiscal year to AU $2.7M. This decline in global sales followed on from a strong
period of ~60% growth in the first 3 quarters of 2020. In April we re-focussed our marketing to promote Travelan
and its sister product, Protectyn , for their gut and digestive health benefits. When travel stops and lockdown
requirements see people isolated at home, dietary habits change, with an increasing prevalence of home food preparation and deliveries
of take-away meals. With these adjustments comes the increased risk of variable personal and commercial food hygiene standards.
FDA registration for clinical development of IMM-124E/Travelan
to prevent travelers' diarrhea suspended
In late March, this year the Immuron board
of directors provided an update to the market regarding the current and future impact of COVID-19 on the company and implemented
swift measures to protect the company's long-term viability. Key among the strategies was a major cost-cutting drive to preserve
cash reserves, and the temporary suspension of dilutive research. Though not taken lightly, we also made the decision to conserve
cash reserves by suspending capital-hungry clinical trial work on our promising assets IMM-124 and IMM-529 until more certain times
return. A series of other cost cutting, and savings steps were also initiated to shore up our medium to long-term cash position.
During this time, the Board also accepted the resignation of Chief Executive Officer, Dr Gary S. Jacob in March, acknowledging
the contribution he had made to the company during his tenure. Dr Jerry Kanellos was appointed Chief Executive Officer and in doing
so, day-to-day control of strategy and operations returned to Australia.
The COVID-19 pandemic resulted in international
travel restrictions and brought to an abrupt halt the travel plans of millions throughout the world. Many countries went into total
lockdown with people unable to leave their homes except for very limited purposes. The pandemic has also caused significant disruptions
to global clinical development with many planned studies being delayed, paused or closed. We have also suspend all work associated
with the IND filing and postpone the planned phase III clinical program for IMM-124E to prevent Travelers' Diarrhea which
was on track to submit an IND application to the FDA in June 2020 and to begin recruitment in July 2020 to coincide with the Northern
hemisphere summer holiday travel period. The International Air Transport Association has reported that the recovery in traffic
Last updated: Sep 1, 2020