Full Press Release Details
| Name of entity: | Immuron Limited |
| ABN: | 80 063 114 045 |
| Reporting period: | For the period ended 31 December 2024 |
| Previous period: | For the period ended 31 December 2023 |
2. Results for announcement to the market
| $ | ||||||||||||
| Revenue from ordinary activities | up | 69.6 | % | to | 3,994,341 | |||||||
| Loss from ordinary activities after tax attributable to the members of Immuron Limited | up | 20.0 | % | to | (2,488,819 | ) | ||||||
| Loss for the period attributable to the members of Immuron Limited | up | 20.0 | % | to | (2,488,819 | ) |
3. Net tangible assets
| Consolidated | ||||||||
| 31 December 2024 | 31 December 2023 | |||||||
| Cents | Cents | |||||||
| Net tangible asset backing (per share) | 4.46 | 7.62 |
The calculation of net tangible assets excludes right-of-use
assets arising from AASB 16 Leases.
4. 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.
6. Changes in controlled entities
There have been no changes in controlled entities during the
period ended 31 December 2024.
7. Details of associates and joint venture entities
| 31 December 2024 | 31 December 2023 | |||||||||
| Name of entity | Place of business/country of incorporation | % | % | |||||||
| Ateria Health Limited | United Kingdom | 23.6 | % | 17.5 | % |
The financial statements have been reviewed by the group's
independent auditor without any modified opinion, disclaimer or emphasis of matters.
the half-year ended 31 December 2024
| Review of operations and activities | 2 |
| Directors' report | 6 |
| Auditor's independence declaration | 7 |
| Consolidated statement of profit or loss and other comprehensive income | 9 |
| Consolidated statement of financial position | 10 |
| Consolidated statement of changes in equity | 11 |
| Consolidated statement of cash flows | 12 |
| Notes to the consolidated financial statements | 13 |
| Directors' declaration | 21 |
| Independent auditor's review report to the members of Immuron Limited | 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 2024 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
of operations and activities
Limited has reported a loss for the half-year ended 31 December 2024 of A$2,488,819 (31 December 2023: A$2,073,182).
group's net assets decreased to A$10,339,516 compared with A$12,709,484 at 30 June 2024, including cash reserves of A$7,736,399 (30 June
2024: A$11,657,315).
from ordinary activities for the half-year ended 31 December 2024 was A$3,994,341 (31 December 2023: A$2,355,580) for Hyperimmune products.
profit of A$2,657,049 (31 December 2023: A$1,580,348).
Operating loss of A$2,538,791 (31 December 2023: A$2,020,028).
half yearly sales of A$4.0 million for HY25 up A$1.6 million on HY24
Sales of Travelan increased to AUD $2.9 million in HY25, compared to AUD $1.9 million in HY24. Sales increased by $1.0 million (54%).
Sales of Travelan increased to AUD $0.7 million in HY25, compared to AUD $0.5 million in HY24. Sales increased by $0.2 million (52%).
Sales of Travelan increased to AUD $0.4 million in HY25 compared to zero in HY24.
submits IMM-529 pre-IND to FDA
filed a pre-IND (investigational new drug) application with the United States Food and Drug Administration (FDA) for IMM529. The increased
incidence of antibiotic resistant superbugs' has amplified the use of broad-spectrum antibiotics worldwide. An unintended
consequence of antimicrobial treatment is disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic
pathogens, such as Clostridioides difficile (C. diff). Paradoxically, treatment of Clostridioides difficile infection (CDI) also involves
antibiotic use, and the heavy reliance on antibiotics to control C. diff does not allow for the gut flora to regenerate and predisposes
the patient to relapsing CDI.
diff is currently the most common pathogen in healthcare associated infections and was deemed an urgent threat in the Center for Disease
Control and Prevention's report on antibiotic resistance threats in the United States (CDC, 2019). CDI affects over 400,000 people
in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually. This serious health threat has led to an urgent
call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections.
address this need, Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention
and/or treatment of recurrent CDI. IMM-529 antibodies targeting C. diff may help to clear CDI infection and promote a quicker re-establishment
of normal gut flora, providing an attractive oral preventative for recurrent CDI.
is collaborating with Dr. Dena Lyras and her team at Monash University, Australia to develop vaccines to produce bovine colostrum-derived
antibodies. Dairy cows were immunised to generate hyperimmune bovine colostrum (HBC) that contains antibodies targeting three essential
C. diff virulence components.
of operations and activities
targets Toxin B (TcB), the spores and the surface layer proteins of the vegetative cells. This unique 3-target approach has yielded promising
results in pre-clinical infection and relapse models, including (1) Prevention of primary disease (80% P =0.0052); (2) Protection of
disease recurrence (67%, P 0.01) and (3) Treatment of primary disease (78.6%, P0.0001; TcB HBC). Importantly IMM-529 antibodies cross-react
with whole cell lysates of many different human strains of C. diff including hypervirulent strains. To our knowledge, IMM-529 is, to
date, the only investigational drug that has shown therapeutic potential in all three phases of the disease. https://doi.org/10.1038/s41598-017-03982-5
achieves record Travelan sales
| Global | HY 2025 AUD$4.0 million up 70% on prior comparative period (pcp) |
| December 2024 Quarter AUD$2.5 million up 249% on pcp and 70% on prior quarter | |
| Australia | HY 2025 AUD$2.9 million up 54% on pcp |
| December 2024 Quarter AUD$1.9 million up 314% on pcp and 83% on prior quarter | |
| USA | HY 2025 AUD$0.7 million up 52% on pcp |
| December 2024 Quarter AUD$0.4 million up 65% on pcp; up 58% on prior quarter | |
| Canada | HY 2025 AUD$0.4 million; pcp was zero |
provides IMM-124E (Travelan ) Phase 2 additional data analysis of Protective Efficacy
Announces New U.S. Department of Defense Research Award for Naval Medical Research Command and Walter Reed Army Institute of Research
U.S. Department of Defense has funded a new program for the Naval Medical Research Command and Walter Reed Army Institute of Research
to develop enhanced formulations of Travelan potentially expanding the coverage of the product as a therapeutic against endemic
military relevant diarrheal pathogens. This work will utilize the extensive experience of the U.S. Department of Defense human infectious
disease vaccine programs and will target key protective antigens of the major enteric bacterial pathogens Campylobacter, Shigella and
Enterotoxigenic E. coli strains not present in the current product formulation. Immuron will negotiate a sub award for this new collaboration
with NMRC and WRAIR to advance this research.
Plans Phase 2 Trial for IMM-529 following FDA review
received favourable feedback from the United States Food and Drug Administration (FDA) on the pre-IND (investigational new drug) information
package to support the clinical development of IMM-529. Following the FDA's guidance and feedback, the Company now plans to file
an investigational new drug (IND) application for IMM-529 to prevent or treat Clostridioides difficile infection (CDI) during the first
half of 2025, followed by a Phase 2 trial of IMM-529 in individuals with Clostridioides difficile infection.
of operations and activities
Reports Results for Campylobacter Controlled Human Infection Model Study
Naval Medical Research Command completed the interim analysis for the clinical evaluation of a new oral therapeutic targeting Campylobacter
and Enterotoxigenic Escherichia coli (ETEC).
Department of Defense
CEO provides key updates at 21st Virtual Investor Summit Microcap Event
of operations and activities
Announces Travelan Clinical Trial Update
(IMM-124E) Phase 2 Clinical Study
A Randomized, Double-blind, Placebo-controlled Trial Assessing the Efficacy of IMM-124E (Travelan ) in a Controlled Human Infection
Model for Enterotoxigenic Escherichia Coli (ETEC)
significant lower levels of IgA and IgG were observed for the subjects who received Travelan compared to those who received
the placebo, which may also reflect levels of exposure to ETEC antigen. Travelan antibodies target and bind to ETEC antigen in the
gastrointestinal tract, block LPS epitopes and therefore reduce antigen exposure, resulting in lower overall IgA and IgG antibody titers.
data also demonstrated there was a statistically significant reduction in the number of colony forming units (CFUs) in
the stools of subjects who received Travelan (p =0.0121), measured 48 hours post challenge, indicating faster clearance of the challenge
strain from the GI tract.
in the Travelan group have a more stable gastrointestinal microbiota over the treatment time period when compared with the Placebo
group. Alpha diversity, a measurement of the richness (how many different species) and evenness (abundance or number of different species)
revealed that the Travelan group had improved richness and Shannon diversity results compared to the Placebo group. The data indicated
a difference in the richness in the diversity of certain species rather than just the abundance or number of bacterial species between
significant differences were identified between the two treatment groups in the Beta diversity tests (number of species and abundance).
The relative abundance results revealed that the Travelan group had increased levels of beneficial bacteria such as Akkermansia and Faecalibacterium.
The differential abundance results confirmed increases in Agathobaculum, Slackia the Eubacterium eligens group, and the Eubacterium siraeum
group; and decreases in Rumminococcus and Bacteroides. The abundance data indicates a possible link between the species of bacteria associated
with reduced inflammation.