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Corporate Governance Immuron Limited and its Board of Directors are committed to implementing and achieving an effective corporate governance framework. Our Corporate Governance Statement can be found on our website at w

Key Takeaway: Immuron Limited has reported a successful fiscal year 2023 with notable sales growth for its oral immunotherapeutic product Travelan in both Australia and North America. Sales increased by 136% globally, showcasing a rebound from pre-pandemic levels as travel resumes. The company received FDA approval for its Investigational New Drug applications for Travelan and a new Campylobacter ETEC therapeutic, indicating promising advancements in their clinical development efforts. Additionally, Immuron has secured a European patent related to treatments for Clostridium difficile infections, strengthening its market position.

Market Sentiment Analysis

POSITIVE FACTORS

  • Significant growth in sales for Travelan in both the US and Australia.
  • FDA approval for IND applications for both Travelan and a new therapeutic product.
  • Successful collaborations with the US Department of Defense for clinical trials.

Full Press Release Details

Corporate Governance
Immuron Limited and its Board of Directors are committed
to implementing and achieving an effective corporate governance framework. Our Corporate Governance Statement can be found on our website
Chairman's letter 3
Review of operations and activities 5
Form 20-F 8
Consolidated Financial Statements 103
Auditor's Independence Declaration 175
Independent Auditor's Report 176
Shareholder Information 181
Corporate Directory 183
On behalf of the Immuron Board, I am
pleased to present the 2022-2023 annual report.
During FY23, your company continued
to pursue opportunities to develop and commercialise our proprietary oral immunotherapeutic products. The company is pleased to report
an uplift of sales in Australia and the USA as international travel continues to increase and significant progression of Immuron's
North America, Travelan sales
were up by 14%, reaching AU $644,020 in FY23, compared to AU $564,400 in FY22. North America, Travelan sales were up by 147%,
reaching AU $1,744,745 in FY23, compared to AU $707,778 in FY22. Global sales of Travelan and Protectyn increased
by 136% in the 2023 fiscal year to AU $1,804,705, compared to AU $765,193 in FY22. This growth was attributable to increasing sales
in both Australian pharmacy and US Passport Health Travel Clinics. Sales numbers in Australia were 90% of the pre-pandemic peak in
FY20 while cumulative Australian resident short-term departures during the 12 months to June 2023 were 74% of those during the pre-
pandemic 12 months to June 2019.
Immuron's FY22 decision to focus
on the clinical development of our most advanced stage therapeutic drug candidates has yielded positive outcomes with the US Food and
Drug Administration (FDA) approval of Investigational New Drug (IND) applications for both Travelan and our new Campylobacter
ETEC therapeutic developed in collaboration with the US Naval Medical Research Command.
The strength and character of our international
relationships, particularly with the United States Department of Defense (DoD) and its agencies the Naval Medical Research Centre (NMRC)
and the Uniformed Services University of the Health Sciences (USU), continue to shine.
Following Institutional Review Board
(IRB) human ethics approval, Immuron received approval from the US Army Medical Research and Development Command (USAMRDC) Office of Human
and Animal Research Oversight (OHRO) to proceed with the clinical trial to evaluate the efficacy of Travelan to prevent
infectious diarrhoea caused by enterotoxigenic Escherichia coli (ETEC). Immuron appointed clinical research organisation (CRO), Pharmaron
to commence screening of candidates for a Phase 2 clinical trial which is designed to evaluate the safety and efficacy of Travelan
compared to placebo in a controlled human infection model (CHIM) in up to 60 healthy participants.
FDA Clinical Hold on the Campylobacter
ETEC IND was lifted in May 2023 and the NMRC will launch two controlled human infection model trials in the US. One trial will focus on
the ability of the hyperimmune product to prevent infectious diarrhea caused by ETEC and the second trial will focus on protecting volunteers
against moderate to severe campylobacteriosis.
USU also reported details of its clinical
trial program to evaluate Travelan in a major field study to assess the products ability to maintain normal gut function
during deployment or travel to high-risk destinations for Travelers' Diarrhea.
The grant of European Patent entitled
"Methods and Compositions for the treatment and/or prophylaxis of Clostridium difficile associated disease" extended our commercial
and legal safety net in the region. In June 2023, the Immuron Board approved proceeding with IMM-529 cGMP manufacturing and to proceed
with FDA pre-IND submission. IMM-529 was developed for the treatment of Clostridioides difficile infection (CDI). CDI can cause life-
threatening diarrhoea and is one of the leading healthcare-related gastrointestinal infections in the world.
In addition to the further commercial
development of our lead candidates, Immuron remains committed to pursuing in parallel organic and M&A growth strategies focusing on
increasing penetration of existing products in existing markets while seeking to increase product offering, market geographies and sales
channels to drive revenue growth and ultimately shareholder value. In November 2022, Immuron completed a strategic investment in Ateria
Health Limited to advance the company's objective to enter the broader IBS market with leading products and to strengthen distribution
of Immuron's Travelan product through B2C online platforms and pharmacy and retail channels (B2B) in target markets.
a loss for the year of A$3,786,507, increasing 33% on 2021-22 as a result of a 136% increase in sales, a 105% in cost of goods sold, a
171% increase in other income, a 68% increase in total expenses and an increase of A$640,770 in other gains/(losses).
I thank my fellow Directors for their dedication and focus
which has helped achieve these positive outcomes.
Independent Non-Executive Chairman
Review of operations and activities
The company is pleased to report an uplift
of sales in Australia and the USA as international travel continued to increase. Australia, Travelan sales were up by
147%, reaching AU $1,744,745 in FY23, compared to AU $707,778 in FY22. North America, Travelan sales were up by 14%,
reaching AU $644,020 in FY23, compared to AU $564,400 in FY22. Global sales of Travelan and Protectyn increased
by 136% in the 2023 fiscal year to AU $1,804,705, compared to AU $765,193 in FY22. This growth was attributable to increasing sales in
both Australian pharmacy and US Passport Health Travel Clinics. Sales numbers in Australia were 90% of the pre-pandemic peak in FY20
while cumulative Australian resident short-term departures during the 12 months to June 2023 were 8274% in April 2023 compared to April
2019of those during the pre-pandemic 12 months to June 2019.
Immuron Board approves IMM-529 manufacturing and
to proceed with FDA pre-IND submission
Immuron reported on June 21, 2023, that it has approved
proceeding with IMM-529 cGMP manufacturing and to proceed with FDA pre-IND submission.
IMM-529 was developed for treatment of Clostridioides
difficile (C. difficile) which is an anaerobic, spore-forming, gram-positive bacillus typically associated with gastrointestinal
disease. Transmission of C. difficile occurs by ingestion of spores either through person-to-person contact, animal-to-person contact
or environment-to-person contact. C. difficile infection (CDI) can cause life-threatening diarrhoea and is the leading healthcare-related
gastrointestinal infection in the world.
European patent awarded to Immuron on drug composition
to treat Clostridioides difficile associated disease
Notification of grant of European
patent entitled "Methods and Compositions for the treatment and/or prophylaxis of Clostridium difficile associated
disease" was received in January 2023 from the European Patent Office (EPO).
Recruitment and Screening Update
for Travelan for use by US military forces
In October 2022, Immuron executed a
clinical trial agreement with US-based clinical research organisation, Pharmaron. On December 5, 2022, Immuron submitted an investigational
new drug (IND) application to the US Food and Drug Administration (FDA) for Travelan . On December 23, 2022, Immuron received FDA
approval for the Travelan IND. On May 30, 2023, following Institutional Review Board (IRB) human ethics approval, Immuron received
approval from the US Army Medical Research and Development Command (USAMRDC) Office of Human and Animal Research Oversight (OHRO) to proceed
with the clinical trial to evaluate the efficacy of Travelan to prevent infectious diarrhoea caused by enterotoxigenic Escherichia
coli (ETEC). On June 22, 2023, Immuron reported that Pharmaron had selected 81 potential candidates for in-person screening visits
which were anticipated to commence on June 28, 2023, at Pharmaron's Clinical Research Facility Inpatient Unit located in Baltimore,
Maryland, US. The Phase 2 clinical trial is designed to evaluate the safety and efficacy of Travelan compared to placebo in a controlled
human infection model (CHIM) in up to 60 healthy participants.
of AU$6.2 million for a research agreement with the US Department of Defense entitled "Biologics License Application (BLA)
of a therapeutic Bovine Immunoglobulin supplement targeting Travelers' Diarrhea caused by Enterotoxigenic Escherichia Coli (ETEC)".
The company was awarded AU$4.8M (US$3.43M) from
the US Department of Defense to test the efficacy of one large daily dose regimen of Travelan in a controlled human infection
model (CHIM) clinical study using the ETEC strain H10407. This dose regime is potentially more amenable for use in military
populations. The US Naval Medical Research Center (NMRC), Silver Spring, MD, USA was also awarded over AU$1.4M (USD $1M) in a
separate grant to provide immunological support for the Immuron clinical program. The company plans to submit an Investigational New
Drug (IND) application with the US Food and Drug Administration (FDA). The clinical program will enroll up to 60 health volunteers
who will be randomly assigned to receive either a once-daily dose of 1200 mg of Travelan or placebo.
The program is to be based on historic
clinical trials with Travelan and ETEC. These showed the product delivered between 84 per cent and more than 90 per cent protective
efficacy against moderate to severe diarrhoea.

Frequently Asked Questions

What is Immuron Limited's focus in recent years?

Immuron Limited has focused on developing and commercializing proprietary oral immunotherapeutic products.

How much did Travelan sales increase in FY23?

Travelan sales in North America increased by 147%, reaching AU $1,744,745 in FY23.

What approval did Immuron receive for Travelan?

The FDA approved the Investigational New Drug (IND) application for Travelan.

What is IMM-529 developed for?

IMM-529 is developed for treating Clostridioides difficile infections.

Which organizations collaborated with Immuron on clinical trials?

Immuron collaborated with the US Naval Medical Research Command and the US Department of Defense.

Last updated: Sep 28, 2023