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Immuron Limited Appendix 4D Half-year 31 December 2022 Name of entity: Immuron Limited ABN: Half-year ended: Previous period: 80 063 114 045 31 December 2022 31 December 2021 Results for announcement to the market $ Reve

Key Takeaway: Immuron Limited has reported encouraging financial results for the half-year ended December 31, 2022, marked by a substantial increase in revenue of 152.7% to $583,646. Despite a net loss after tax that rose by 9.2% to $1,978,383, the company achieved FDA approval to initiate a clinical trial for Travelan, its product aimed at preventing infectious diarrhea. Additionally, a European Patent has been secured for a method to treat Clostridium difficile, enhancing its position in the market. Overall, the company continues its development efforts while facing challenges related to profitability.

Market Sentiment Analysis

POSITIVE FACTORS

  • Revenue increased by 152.7% to $583,646.
  • FDA approval received for the clinical evaluation of Travelan.
  • European Patent granted for drug composition to treat Clostridioides difficile.

CONCERNS & RISKS

  • Net loss after tax increased by 9.2% to $1,978,383.
  • Net tangible assets per share decreased from 10.51 cents to 9.25 cents.
  • No dividends have been declared for the current financial period.

Full Press Release Details

Name of entity: Immuron Limited
ABN: Half-year ended: Previous period: 80 063 114 045 31 December 2022 31 December 2021
Results for announcement to the market
$
Revenue from ordinary activities Up 152.7% to 583,646
Net loss after tax (from ordinary activities) for the period attributable to members Up (9.2)% to (1,978,383 )
Net loss after tax for the period attributable to members Up (9.2)% to (1,978,383 )
Net tangible assets per security
31 December 31 December
2022 Cents 2021 Cents
Net tangible asset backing (per share) 9.25 10.51
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 2022.
Other information required by Listing Rule 4.2A
Name of entity Place of business/ country of incorporation Ownership interest held by the group 31 December 2022 %
Ateria Health Limited United Kingdom 17.1
On 25 November 2022, Immuron has been allotted 800,767 shares
in Ateria Health Limited (Ateria), representing 17.5% of the issued share capital of Ateria post the group's upfront cash investment,
following satisfaction of conditions precedent for the transaction, including completion of Immuron confirmatory due diligence and Ateria
shareholder approval. As at 31 December 2022, Immuron has a 17.1% interest and one board seat in Ateria.
Immuron is deemed to have significant influence over Ateria.
For more information, refer to note 12(b).
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
Interim report - 31 December 2022
Contents Page
Review of operations and activities 2
Directors' report 4
Auditor's Independence Declaration 6
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 27
Independent auditor's report to the members 28
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 2022 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
Immuron Limited has reported a loss for the half-year ended 31 December
2022 of A$1,978,383 (31 December 2021: A$1,811,454). The group's net assets decreased to A$21,264,280 compared with A$23,177,401 at 30
June 2022, including cash reserves of A$18,475,125 (30 June 2022: A$22,110,278).
Immuron Receives FDA Approval for Travelan IND Application;
Immuron Executes Clinical Trial Agreement with Pharmaron
2022 the company announced FDA approval to proceed with the clinical evaluation of Travelan. The Investigational New Drug (IND) application
to evaluate the safety and efficacy of a single dose of Travelan to prevent infectious diarrhea caused by Enterotoxigenic Escherichia
Coli (ETEC) is now active. The company will proceed with the planned clinical trial in the United States. The Phase Two clinical
trial will evaluate Travelan in a controlled human infection model clinical trial
design. Immuron announced in October 2022 that it is the sponsor of the IND and the clinical study will be conducted by Pharmaron CPC,
at its FDA inspected clinical research facility located in Baltimore, Maryland.
The 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.
updated on Uniformed Services University of the Health Sciences and Travelan clinical field trial
The company announced in January
the Uniformed Services University of the Health Sciences (USU) clinical trial program to evaluate Travelan had recruited 157 of 1032 study
participants. Travelan is our successful over-the-counter non-antibiotic treatment for Traveler's Diarrhea. USU anticipated to complete
clinical trial enrolment in 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
The P3TD study is a randomized,
double-blind, placebo controlled multicenter clinical trial designed to evaluate the effectiveness of 2 commercially available nutraceuticals:
a probiotic (Florastor ) and IMM-124E (Travelan ) passive immunoprophylaxis verses a placebo, for prophylaxis during deployment
or travel to a high- TD risk region.
Immuron US Department of Defense/NMRC receives
FDA feedback on IND application for Campylobacter and ETEC therapeutic
The FDA placed a clinical hold
on clinical trials of the new oral therapeutic under the IND application. The Sponsor Investigator and Principal Investigator from John
Hopkins University (JHU) Bloomberg School of Public Health and personnel from the Naval Medical Research Institute (NMRC) and Immuron
received written guidance from the FDA on a path forward to address the safety concerns and supporting data associated with this new product.
JHU, NMRC and Immuron addressed each specific concern raised in the FDA's written guidance. FDA feedback is anticipated in calendar
Immuron Receives European Patent
on Drug Composition to Treat Clostridioides difficile
The company also recently announced
that it has been granted European Patent 2986316, entitled "Methods and Compositions for the treatment and/or prophylaxis of Clostridium
difficile associated disease", will be published on January 25, 2023. The European registration adds to Immuron's patent position
for compositions and methods for treating Clostridioides difficile in Australia, New Zealand and the Unites States.
The company has continued to develop
a business plan for the development of IMM-529 to treat Clostridioides difficile infection (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.
Immuron Completes Strategic Investment
in Leading Gut Health Biotech Ateria Health
2022 the company announced completion of settlement of strategic investment in Ateria Health Limited (Ateria); investment of approximately
1.5m (A$2.6m) to acquire an initial 17.5% with an option for a further investment of 1.47m expiring on 31 July 2023. Ateria
is a UK based company that developed and recently launched a ground-breaking product, JuviaTM
for the treatment of irritable bowel syndrome (IBS).
and Ateria intend to enter into reciprocal distribution agreements for Travelan
in the UK market and JuviaTM in Australian and North American markets.
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 2022.
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
Daniel Pollock, Independent Non-Executive Director
Mr Stephen Anastasiou, Independent Non-Executive Director
Prof. Ravi Savarirayan, Independent Non-Executive Director
Mr Paul Brennan, Independent Non-Executive Director
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 in the treatment of diseases associated with the gastrointestinal tract. We believe that we can address this significant
unmet medical need. Our polyclonal antibodies are orally active and offer localized delivery within the gastrointestinal ("GI")
tract. As our products do not cross from the gut into the bloodstream, they potentially offer much improved safety and tolerability, without
sacrificing efficacy. We currently market our flagship commercial products Travelan and Protectyn in Australia, both products

Frequently Asked Questions

What was Immuron's revenue growth in the half-year ended December 2022?

Immuron reported a revenue increase of 152.7%, totaling A$583,646.

How much was Immuron's net loss after tax for the half-year?

The net loss after tax for the period was A$1,978,383, an increase of 9.2%.

What stake does Immuron hold in Ateria Health Limited?

Immuron holds a 17.1% interest in Ateria Health Limited as of December 31, 2022.

Has Immuron declared any dividends for the reported period?

No dividends were declared or paid by Immuron for the current or previous period.

What FDA approval did Immuron receive in late 2022?

Immuron received FDA approval to proceed with Travelan's clinical evaluation.

Last updated: Feb 28, 2023