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Immuron Limited Appendix 4D Half-year 31 December 2021 Name of entity: Immuron Limited ABN: Half-year ended: Previous period: 80 063 114 045 31 December 2021 31 December 2020 Results for announcement to the market $ Reve

Key Takeaway: Immuron Limited Appendix 4D Half-year 31 December 2021 Name of entity: Immuron Limited ABN: Half-year ended: Previous period: 80 063 114 045 31 December 2021 31 December 2020 for announcement to the market $ Revenue from ordinary activities Up 1,037.2% to 230,964 Ne

Full Press Release Details

Immuron Limited Appendix 4D Half-year 31 December 2021
Name of entity: Immuron Limited
ABN: Half-year ended: Previous period: 80 063 114 045 31 December 2021 31 December 2020
for announcement to the market
$
Revenue from ordinary activities Up 1,037.2% to 230,964
Net loss after tax (from ordinary activities) for the period attributable to members Down 68.4% to (1,811,454 )
Net loss after tax for the period attributable to members Down 68.4% to (1,811,454 )
Net tangible assets per security
31 December 31 December
2021 Cents 2020 Cents
Net tangible asset backing (per share) 10.51 12.56
calculation of net tangible assets excludes right-of-use assets arising from AASB 16 Leases.
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 financial
in controlled entities
have been no changes in controlled entities during the half-year ended 31 December 2021.
information required by Listing Rule 4.2A
financial statements have been reviewed by the group's independent auditor without any modified opinion, disclaimer or emphasis of matters.
the half-year 31 December 2021
report - 31 December 2021
Contents Page
Review of operations and activities 2
Directors' report 4
Interim financial report 7
Condensed consolidated statement of profit or loss and other comprehensive income 8
Condensed consolidated statement of financial position 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 21
Independent auditor's report to the members 22
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 2021 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.
of operations and activities
Limited has reported a loss for the half-year ended 31 December 2021 of A$1,811,454 (31 December 2020: A$5,738,772). The group's net
assets decreased to A$24,177,656 compared with A$25,895,057 at 30 June 2021, including cash reserves of A$22,794,568 (30 June 2021: A$25,047,281).
Awarded $6.2 Million to Clinically Evaluate a Military Strength Dosing Regimen for Travelan
January 2022 the company announce the funding of a new research agreement with the U.S Department of Defense. The focus of this new agreement,
entitled "Biologics License Application (BLA) of a therapeutic Bovine Immunoglobulin supplement targeting Travelers' Diarrhea
caused by Enterotoxigenic Escherichia Coli (ETEC)", is aimed at testing and confirming the efficacy of a single larger dose regimen
of Travelan in a controlled human infection model (CHIM) clinical study using the enterotoxigenic Escherichia coli (ETEC)
strain H10407. This single larger dosing regime is potentially more amenable for use in military populations. Up to 60 volunteers will
be enrolled in the clinical study and will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan or placebo.
This study will occur across two cohorts (n=15 Travelan subjects and n=15 placebo subjects per cohort), as the inpatient unit can
accommodate up to 30 study participants at a time. Results of the proposed clinical study will also inform on dosing in the pivotal Phase
3 registration trials for BLA licensure. A project kickoff meeting for this award was held on the 25 of January 2022 with the U.S Government
sponsors and representatives of the company, the Naval Medical Research Center, Navy Advanced Medical Development and the Medical Technology
Enterprise Consortium.
proposed development program is based on the past commercial and clinical trial experience with Travelan . Two company sponsored
clinical studies have demonstrated that Travelan conferred 84% to over 90% protective efficacy against moderate to severe diarrhea
upon challenge with ETEC in comparison to a placebo. These clinical studies were performed using two different doses of Travelan
(200 mg and 400 mg), administered 3 times a day. Ongoing discussions with Army and Navy leadership have highlighted that such a regimen
is cumbersome for military personnel deployed in austere environments and military field studies have shown that compliance is low with
products dosed more than once per day.
restrictions lifted on US Department of Defence/NMRC Campylobacter and ETEC clinical development campaigns
more than 12 months' COVID-19 related delay, Immuron's clinical development collaboration with the US Department of Defence
(DoD) has resumed. The program recommenced with the company reporting the completion of cGMP manufacturing for the new drug product targeting
Campylobacter and Enterotoxigenic Escherichia coli (ETEC) in October. The investigational medical products will be transferred
to the Johns Hopkins Bloomberg School of Public Health (JHBSPH), the site for the two planned human clinical studies planned to launch
in the first half of 2022. One will focus on the hyperimmune product's ability to protect volunteers against ETEC infections, and
the second on moderate to severe campylobacteriosis. NMRC has begun work on the Investigational New Drug (IND) application and clinical
protocols. It plans to file the application with the US Food and Drug Administration (FDA) in early 2022.
updated on US Department of Defence and Travelan clinical trials
company received a second purchase order in January 2022 to supply Travelan drug substance to support the Uniformed Services University
(USU) planned clinical trial program to evaluate the efficacy of Travelan and two other non-antibiotic OTC products in Travelers'
company announced in November details of the Uniformed Services University of the Health Sciences (USU) clinical trial program to evaluate
Travelan. Travelan is our successful over-the-counter non-antibiotic treatment for Traveler's Diarrhea. It will join two other
commercial nutraceuticals in the human trials. USU reported it began production of the first batches of investigational medical products
to support the clinical trial program in November. It said it expected enrolment to commence in April 2022 and conclude within about
18 months. Along with the USU's Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defence and the New York
City Travel Clinic have undertaken to carry out the randomized, double blind, placebo-controlled trial involving 1,336 volunteers.
P4TD study is a randomized, double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of 3 commercially
available nutraceuticals: A prebiotic (Bimuno ), a probiotic (Florastor ) and IMM-124E (Travelan ) passive immunoprophylaxis
verses a placebo, for prophylaxis during deployment or travel to a high-TD risk region.
Receives European Patent on Drug Composition to Treat Travelers' Diarrhea
company also recently announce that it has been granted a European Patent for compositions and methods for treating travelers'
diarrhea. European Patent 3159357, entitled "Composition and method for the treatment and prevention of enteric bacterial infections",
was granted on January 5, 2022. Immuron is validating the patent in the following European member states, France, Spain, Sweden, Austria,
Germany, Denmark, Finland, Greece and United Kingdom. The European registration adds to Immuron's patent position for compositions and
methods for treating travelers' diarrhea in Australia, India, Canada and the Unites States.
Development of IMM-529 in patients with Clostridiodes difficile infection (CDI)
company has continued its clinical development effort to focus resources on the development of IMM-529 to treat CDI patients subject
to recurrent disease through a formal filing of an IND with FDA. Recurrent CDI continues to be a major unmet medical need with limited
treatment options available for patients suffering with CDI.
results reported for IMM-124E's antiviral T-cell immunity trials against the SAS-CoV-2 virus that causes COVID-19
results from studies describing the potential antiviral benefits of IMM-1124E have led to a patent application for international protection
for the product. IMM-124E is Immuron's proprietary product. It is the manufacturing basis for our commercial, over-the-counter
digestive health supplements, Travelan and Protectyn . The Israeli Hadassah Medical Centre carried out the pre-clinical
models and a phase I/IIa clinical trial. The pre-clinical study exposed mice to viral antigens of swine flu, New Caledonia influenza,
and cytomegalovirus. The data suggest IMM-24 enhances antiviral immunity across those strains, with a similar response in the human study
involving SARS-CoV-2 and Hepatitis B.
of vaccine R&D company shelved
After filing with the ASX a
detailed ASX In-Principal Advice Application and subsequent lengthy discussions and exchanges with the ASX, the ASX advised Immuron that
it was not able to be satisfied that the combined group after the proposed acquisition would meet those requirements under chapters 1
and 2 of the ASX Listing Rules.
Immuron as a result was unable to satisfy the pre-conditions for the
proposed acquisition due to the expiration of the existing contractual timetable and could not proceed with the proposed acquisition in
its form. There were no break fees associated with being unable to satisfy the preconditions existing contractual timetable, however professional
fees associated with this transaction over the 4 months were approximately $450k plus GST (together with customary out of pocket expenses).
pandemic continues to impact travel in all Travelan territories
COVID-19 pandemic has significantly disrupted international travel throughout the world and continues to impact every Travelan market.
The International Air Transport Association has reported that the recovery in traffic will be very slow and probably will not return
to pre-COVID-19 levels until 2024. The recovery in short-haul travel is expected to happen faster than for long haul travel which also
may require a vaccination certificate for anyone planning to Travel. The company is pleased to report a continued uplift of sales currently
being observed in the USA as travel restrictions nationally and internationally increase.
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 2021.
The following persons were directors of Immuron Limited
during the whole of the half-year and up to the date of this report:
Dr Roger Aston, Independent
Non-Executive Chairman
Mr Peter Anastasiou, Executive Vice Chairman (resigned 24 September 2021)
Mr Daniel Pollock, Independent Non-Executive
Last updated: Feb 25, 2022