Full Press Release Details
| Name of entity: | Immuron Limited |
| ABN: | 80 063 114 045 |
| year ended: | 30 June 2024 |
| Previous period: | 30 June 2023 |
Results for announcement to the market
| $ | ||||||||
| Revenue from ordinary activities | Up | 171.7% to | 4,902,865 | |||||
| Loss from ordinary activities after tax attributable to members | Up | 83.2% to | (6,936,957 | ) | ||||
| Net loss for the period attributable to members | Up | 83.2% to | (6,936,957 | ) |
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
The reported after tax loss of the
current financial year of $6,936,957 (2023: $3,786,507) is after fully expensing the company's research and development expenditure
of $5,375,461 incurred during the year (2023: $2,592,145). Of which, $2,599,458 (2023: $2,158,936) was funded by the R&D grant from
Medical Technology Enterprise Consortium (MTEC). Research and development expenses increased by $2,783,316 from the financial year 2023
The revenue from contracts with customers
for the year was $4,902,865, which is an increase of 171.7% from the prior financial year (2023: $1,804,705), primarily due to the sales
recovery in the Australian, U.S. and North American markets for Travelan . We anticipate that revenues from sales of our
Travelan product will continue to increase in the future.
As at 30 June 2024 the company's
cash position was $11,657,315 (30 June 2023: $17,159,764). The company had trade and other receivables of $1,387,573 (30 June 2023: $417,420).
This receivables amount includes future receivables from the Australian Government under the R&D Tax Incentive program mentioned above.
The preliminary financial report
follows, with the further details to be included in the audited financial statements to be released by 30 September 2024.
tangible assets per security
| 2024 Cents | 2023 Cents | |||||||
| Net tangible asset backing (per security) | 5.51 | 8.53 |
Changes in controlled entities
There have been no changes in controlled entities during the
year ended 30 June 2024.
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: |
| Ownership interest held by the group | ||||||||||
| Place of business/ | 30 June 2024 | 30 June 2023 | ||||||||
| Name of entity | country of incorporation | % | % | |||||||
| Ateria Health Limited | United Kingdom | 23.6 | 17.5 |
As at 30 June 2024, Immuron has a 23.61% interest in Ateria.
Immuron is deemed to have significant influence over Ateria.
The financial statements are currently in the process of being
audited. The audited financial statements along with the independent auditor report for the year end 30 June 2024 will be provided in
of operations and activities
Immuron Limited has reported a
loss for the financial year ended 30 June 2024 of A$6,934,691 (30 June 2023: A$3,787,519). The group's net assets decreased to A$12,709,444
compared with A$19,616,836 at 30 June 2023, including cash reserves of A$11,657,315 (30 June 2023: A$17,159,764).
Record sales of A$4.9
million for FY24 up A$3.1 million on FY23
Australia: Sales of Travelan
increased to AUD $3.7 million in FY24, compared to AUD $1.1 million in FY23. Sales increased by $2.6 million (223%).
Consistent with the increase
in June 2024 quarter sales, the Australian Bureau of Statistics reported short term resident returns in April 2024 were 29% higher than
USA: Sales of Travelan
increased to AUD $1.1 million in FY24, compared to AUD $0.6 million in FY23. Sales increased by $0.4 million (67%).
Immuron's experience in
the USA follows the International Trade Administration Total U.S. citizen international visitor departures from the United States in
April 2024 being 8% higher than in April 2023.2
| 1. | https://www.abs.gov.au/statistics/industry/tourism-and-transport/overseas-arrivals-and-departures-australia/latest- release |
| 2. | https://www.trade.gov/us-international-air-travel-statistics-i-92-data |
Immuron completes IMM-124E Phase 2 clinical trial
The inpatient challenge phase of the Travelan
clinical study led by Principal Investigator Dr Mohamed Al- Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient
Unit located in Baltimore, Maryland US, has been completed. The double-blind study was separated into two cohorts of approx. 30 subjects
(60 in total) dosed with Travelan or placebo for two days prior to challenge and continuing dosing for a total of 7 days. All study
participants were challenged with Escherichia coli, monitored for symptoms, and treated with antibiotics. Safety data at two weeks and
4 weeks post challenge has been collected and the final 6 month follow up interviews were completed. The Phase 2 clinical trial was designed
to evaluate the safety and protective efficacy of Travelan compared to a placebo in a controlled human infection model (CHIM). The
primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT05933525. Topline
clinical trial results demonstrate a 36.4% protective efficacy with single daily dose of Travelan against Enterotoxigenic Escherichia
coli (ETEC) induced moderate to severe diarrhea compared to the placebo group (primary endpoint) even though the attack rate for this
study was 37%, much lower than the planned 70%. The attack rates on previous Phase 2 (Otto et al. 2011) were 73% and 86% with protective
efficacy of 90.9% and 76.7%. There was a 43.8% reduction in diarrhea of any severity in the Travelan group compared to the Placebo
group during the 5-day period post challenge which is approaching statistical significance; p=0.066. The number of cumulative adverse
events per participant in the Travelan group (58) was statistically significantly lower than the Placebo group (109); p<0.05.
The Phase 2 clinical study data also supports the excellent safety and tolerability profile of Travelan . Immuron will now proceed
to hold an end of Phase 2 meeting with the U.S Food and Drug Administration to discuss the pivotal Phase 3 registration strategy and planned
clinical trials including recommended dosing to support a Biologics License Application (BLA) for Travelan as a prophylactic medicine
for Travelers' Diarrhea.
Immuron completes in-patient phase
of CampETEC Phase 2 clinical trial
The NMRC has recently completed
the in-patient stage of the campylobacter challenge clinical study. The clinical study was led by Principal Investigator Dr Kawsar Talaat,
MD at the Johns Hopkins University (JHU) Center for Immunization Research (CIR) Inpatient Unit, located at the JHU Bayview Medical Campus,
Baltimore, Maryland. U.S. A total of 30 participants were enrolled in the study, of which 27 participants were dosed with either the Investigational
Medical Product or placebo and all subjects were challenged with Campylobacter. All study volunteers were treated with antibiotics and
discharged from the clinic. The study participants returned as outpatients for several follow-up visits, with the last patient last visit
completed in June 2024. Headline results from the clinical trial are anticipated to be reported in late August 2024/early September 2024.
The Phase 2 clinical trial was designed to evaluate the safety and protective efficacy of the new product manufactured by Immuron compared
to a placebo in a controlled human infection model (CHIM). The primary efficacy outcome is prevention and/or reduction of moderate to
severe diarrhea. ClinicalTrials.gov Identifier: NCT06122870.
Uniformed Services University
Travelan clinical field trial reaches 77% recruitment
USU's Infectious Diseases
Clinical Research Program (IDCRP) and the UK Ministry of Defense are jointly conducting the randomized clinical trial to evaluate the
efficacy of Travelan in Travelers' Diarrhea. The P2TD study is a randomized, double-blind,
placebo controlled multicenter clinical trial designed to evaluate the effectiveness of IMM-124E (Travelan )
passive immunoprophylaxis verses a placebo, during deployment or travel to a high-TD risk region (ClinicalTrials.gov Identifier: NCT04605783).
All study participants (866 in total) will be randomized to Travelan or placebo (433 per arm).
The Problem: Travelers'
diarrhea (TD) remains a highly prevalent disease that impacts operational readiness of military personnel and is also debilitating to
civilians traveling to high-risk destinations. In addition to its acute morbidity, TD is associated with acquisition of antimicrobial
resistance genes and long-term sequelae. Current mitigation strategies including pre-travel counseling and antibiotics for prevention
and treatment which have important limitations, and there are currently no licensed, pathogen-specific vaccines for TD prevention.
The Approach: Passive immunotherapy
may offer safe and relatively inexpensive preventive strategies by promoting gut resistance to enteropathogens, and potentially lessening
the use of antibiotics. USU's Infectious Diseases Clinical Research Program (IDCRP) and the UK Ministry of Defense are jointly conducting
the trial to evaluate the efficacy of Travelan for TD prevention and inform strategies for Force Health Protection.
More than 77% of the target 866 study participants have
been recruited. Topline results are anticipated in 1Q 2025.
Immuron submits pre-IND for IMM-529 to the U.S. Food
and Drug Administration (FDA)
Immuron filed a pre-IND (investigational