Full Press Release Details
Half-year 31 December 2020
| Name of entity: | Immuron Limited |
| ABN: | 80 063 114 045 |
| Half-year ended: | 31 December 2020 |
| Previous period: | 31 December 2019 |
| Results for announcement to the market | ||||||||||
| $ | ||||||||||
| Revenue from ordinary activities | Down | (98.7)% to | 20,309 | |||||||
| Net loss after tax (from ordinary activities) for the period attributable to members | Up | (277.2)% to | (5,738,772 | ) | ||||||
| Net loss after tax for the period attributable to members | Up | (277.2)% to | (5,738,772 | ) |
Net tangible assets per security
| 31 December | 31 December | |||||||
| 2020 | 2019 | |||||||
| Cents | Cents | |||||||
| Net tangible asset backing (per share) | 12.56 | 3.82 |
The calculation of net tangible assets excludes right-of-use
assets arising from AASB 16 Leases.
Explanation of results
An 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.
No dividends have been paid or declared by the company for the
current financial period. No dividends were paid for the previous financial period.
Changes in controlled entities
There have been no changes in controlled entities during the
half-year ended 31 December 2020.
Other 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 |
The financial statements have been reviewed by the group's independent
auditor without any modified opinion, disclaimer or emphasis of matters.
Interim financial report
for the half-year 31 December
Interim report - 31 December 2020
| Contents | Page | |
| Directors' report | 2 | |
| Interim financial report | ||
| Condensed consolidated statement of profit or loss and other comprehensive income | 9 | |
| Condensed consolidated statement of financial position | 10 | |
| Condensed consolidated statement of changes in equity | 11 | |
| Condensed consolidated statement of cash flows | 12 | |
| Notes to the condensed consolidated financial statements | 13 | |
| Directors' declaration | 22 | |
| Independent auditor's report to the members | 24 |
This interim financial report does not include all the notes
of the type normally included in an annual financial report. Accordingly, this report should be read in conjunction with the annual
report for the year ended 30 June 2020 and any public announcements made by Immuron Limited during the interim reporting period
in accordance with the continuous disclosure requirements of the Corporations Act 2001.
Your 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 2020.
The following persons held office as directors of Immuron Limited
during the financial period:
Mr Stephen Anastasiou
Prof. Ravi Savarirayan
Principal activities
We are a commercial and clinical-stage biopharmaceutical company
with a proprietary technology platform focused on the development and commercialization of a novel class of specifically targeted
polyclonal antibodies that we believe can address significant unmet medical needs. Our oral polyclonal antibodies offer delivery
within the gastrointestinal ("GI") tract and essentially do not cross into the bloodstream, potentially leading to
much improved safety and tolerability, without sacrificing efficacy. We currently market our flagship commercial products Travelan
and Protectyn in Australia, both products are listed medicines on the Australian Register for Therapeutic Goods. Travelan
is an over-the-counter product indicated to reduce the risk of travelers' diarrhea and is sold in pharmacies throughout Australia.
Protectyn is currently sold as a practitioner only brand and is marketed as an immune supplement to help maintain a healthy
digestive function and liver. We also market Travelan in Canada where it is licensed as a natural health product indicated
to reduce the risk of travelers' diarrhea, and presently market Travelan in the U.S. as a dietary supplement for digestive
We currently have two lead drug candidates in clinical development,
which we believe have the potential to transform the existing treatment paradigms for moderate to severe campylobacteriosis, travelers'
diarrhea and for Clostridium difficile infections.
Review of operations
Immuron Limited has reported a loss for the half-year ended
31 December 2020 of A$5,738,772 (31 December 2019: A$1,521,227). The group's net assets increased to A$28,540,646 compared with
A$5,643,913 at 30 June 2020, including cash reserves of A$26,444,768 (30 June 2020: A$3,250,468).
Review of operations (continued)
Naval Medical Research Center (NMRC) project to develop and
clinically evaluate new therapeutic against Campylobacter and ETEC
In July 2020, Immuron announced that the Naval Medical Research
Center (NMRC) received written guidance from the U.S. Food and Drug administration (FDA) in relation to the clinical development
pathway of a new investigational 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 which the company is developing to prevent Campylobacter and ETEC mediated moderate to severe diarrhea. Following
FDA review the agency provided a written response to the non-clinical questions posed in the briefing documentation as well as
providing additional guidance and comments to support the planned IND submission.
The vaccination campaign was initiated in June 2020 and utilized
a bispecific vaccine developed by the NMRC which is made up of the capsule of C. jejuni chemically conjugated to the CFA/I pilin
of ETEC. The NMRC has demonstrated that the vaccine is immunogenic in small animal models and shown that C. jejuni capsule conjugate
vaccines were 100% protective against campylobacteriosis in the non-human primate model. The vaccination campaign was successfully
completed in August 2020 and each animal in the herd received three doses of the vaccine. The hyper-immune colostrum was harvested
in September and samples were shipped to the NMRC, a research arm of the DoD, located in Silver Spring, Maryland, for immunological
In November 2020 the company reported that the NMRC had completed
the characterization of the colostrum harvested from cows immunized with the experimental vaccine developed to target Campylobacter
and Enterotoxigenic E.coli (ETEC). The NMRC confirmed that the conjugated vaccine produced a robust immunological response in cows
and reported that the new Hyper-immune therapeutic contains high levels of antibodies which specifically target Campylobacter jejuni
capsule and Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1 (CFA/1). These are key antigenic targets predicted
to be protective against diarrhea induced by both pathogens. The US DoD noted that the colostrum contained high levels of specific
immunoglobulins against the target antigens in the vaccine and furthermore, was shown to contain functional antibodies capable
of inducing hemoglutination inhibition of the CFA/1 specific ETEC strain to be used in one of the two planned controlled human
infection-model clinical trials.
The manufacturing campaign for the placebo drug product was
completed in December 2020 and the company plans to initiate the manufacture of the active drug substance in Q1 2021 and complete
the manufacture of the active drug product in Q2 2021. Work on the Investigational New Drug (IND) application and the clinical
protocols for evaluating the safety and efficacy of the product in moderate to severe campylobacteriosis and Enterotoxigenic Escherichia
coli (ETEC) infections is progressing well. The NMRC plans to file the IND application with the U.S. Food and Drug administration
(FDA) in Q2 2021. The ability of the new hyperimmune product to protect volunteers from moderate to severe campylobacteriosis and
ETEC disease will be assessed during two inpatient clinical trials planned for Q3 and Q4 2021. A total of 60 volunteers divided
into two inpatient cohorts will be enrolled in the study and randomly assigned to either Cohort 1 C. jejuni or Cohort 2 ETEC controlled
human infection models. Preliminary read outs from the clinical studies are expected to be reported by the end of 2021.
Review of operations (continued)
Immuron's Hyper-immune Bovine Colostrum used to manufacture
Travelan and Protectyn demonstrates antiviral activity against the COVID-19 virus
Also, in July 2020 the company announced to the market that
the hype-Immune bovine colostrum used to manufacture the company's flag ship commercially available and over-the-counter
gastrointestinal and digestive health immune supplements Travelan and Protectyn demonstrated neutralizing activity against
the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. The cytopathic effect inhibition
cell-based assay was established and performed by 360biolabs, 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
In December 2020, the company announced that it had executed
a new Research Agreement with Monash University to develop new immunological assays to evaluate the efficacy of IMM-124E, the active
pharmaceutical ingredient used to manufacture Travelan and Protectyn to further our understanding of the inhibitory substance/s
in the commercial products. The research team will be led by Dr Melanie Hutton and Professor Dena Lyras, Deputy Director, Biomedicine