Full Press Release Details
| Immuron Limited | |
| Appendix 4D | |
| Half-year report |
| Name of entity: | Immuron Limited |
| ABN: | 80 063 114 045 |
| Reporting period: | For the period ended 31 December 2025 |
| Previous period: | For the period ended 31 December 2024 |
2. Results for announcement to the market
| $ | ||||||||||
| Revenue from ordinary activities | up | 4.8 | % | 4,184,357 | ||||||
| Loss from ordinary activities after tax attributable to the members of Immuron Limited | down | 22.9 | % | to | (1,919,074) | |||||
| Loss for the period attributable to the members of Immuron Limited | down | 22.9 | % | to | (1,919,074) |
3. Net tangible assets
| Consolidated | ||||||||
| 31 December | 31 December | |||||||
| 2025 Cents | 2024 Cents | |||||||
| Net tangible asset backing (per share) | 3.94 | 4.46 |
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 2025.
7. Details of associates and joint venture entities
| 31 December | 31 December | |||||||||
| 2025 | 2024 | |||||||||
| Name of entity | Place of business/country of incorporation | % | % | |||||||
| Ateria Health Limited | United Kingdom | 23.61 | % | 23.61 | % |
The financial statements have been reviewed by the
group's independent auditor without any modified opinion, disclaimer or emphasis of matters.
Interim financial report
Half-year ended 31 December 2025
| Review of operations and activities | 1 | |
| Directors' report | 4 | |
| Auditor's independence declaration | 4 | |
| Financial statements | 6 | |
| Consolidated statement of profit or loss and other comprehensive income | 7 | |
| Consolidated statement of financial position | 8 | |
| Consolidated statement of changes in equity | 9 | |
| Consolidated statement of cash flows | 10 | |
| Notes to the consolidated financial statements | 11 | |
| Directors' declaration | 19 | |
| Independent auditor's review report to the members of Immuron Limited | 21 |
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 2025 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.
Review of operations and activities
Immuron Limited has reported a loss for the half-year ended
31 December 2025 of A$1,919,074 (31 December 2024: A$2,488,819).
The group's net assets increased to A$13,076,439 compared
with A$8,069,055 at 30 June 2025, including cash reserves of A$9,995,328 (30 June 2025: A$2,830,526).
Revenue from ordinary activities for the half-year ended
31 December 2025 was A$4,184,357 (31 December 2024: A$3,994,341) for Hyperimmune products.
Gross profit of A$2,653,690 (31 December 2024: A$2,657,049).
Operating profit from Hyperimmune products of A$984,881
(31 December 2024: A$1,064,396).
Record half-yearly sales of A$4.2 million for HY26
Australia: Sales of Travelan
increased to AUD $3.2 million in HY26, compared to AUD $2.9 million in HY25. Sales increased by $0.3 million (11%).
USA: Sales of Travelan
increased to AUD $0.9 million in HY26, compared to AUD $0.7 million in HY25. Sales increased by $0.2 million (17%).
Canada: Sales of Travelan
decreased to AUD $0.1 million in HY26 compared to AUD $0.4 million in HY25.
FDA approval of IMM-529 IND application
Immuron received U.S. Food and Drug administration (FDA)
approval for IMM-529 Investigational New Drug (IND) application and to proceed the clinical study. The FDA assigned an IND number (032095)
for the IMM-529 application.
IND 32095 is Immuron's Investigational new drug (IND)
application for clinical development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI) and
Opportunity assessment by Lumanity
indicates that if efficacious, IMM-529 would be positioned as early in treatment algorithm as payers will allow. It was anticipated that
first-episode and recurrent patients will be recruited in the IMM-529 Phase 2 clinical trial design. Up to ~98k patients would be eligible
if IMM-529 is positioned at the first recurrence. Based on the estimated market size, anticipated payer restrictions, pricing, and competition,
base case yearly revenue for IMM-529 is projected at US$400M. Oral dosing of IMM-529 was viewed as a positive by infectious disease experts.
C. 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.
To 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.
Immuron 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.
IMM-529 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.
New US Department of Defense
award to develop two new oral therapeutics targeting Campylobacter and Shigella
As previously announced on August 16, 2024, the
Naval Medical Research Command and the Walter Reed Army Institute of Research, in collaboration with Immuron, are progressing the development
of novel vaccines targeting Campylobacter jejuni and Shigella sonnei. Under a recently executed collaborative research agreement with
the Henry M. Jackson Foundation, new vaccine preparations against these pathogens have been developed and formulated at the military research
institutes and subsequently provided to Immuron. Utilizing its proprietary technology platform, Immuron will produce two hyper-immune
bovine colostrum products for pre-clinical evaluation, with the objective of advancing a combined colostrum-based therapeutic specifically
designed for the US military.
Uniformed Services University releases topline
The Uniformed Services University has released topline
results from its clinical trial evaluating the effectiveness of a third party manufactured product containing enterotoxigenic E. coli
(ETEC) hyperimmune bovine colostrum (IMM-124E) in maintaining gut health during deployment and travel. The primary endpoint did not reach
statistical significance. The investigational product was manufactured by a third party and was not administered in accordance with Travelan
directions for use. Immuron will propose the established and clinically validated three times daily dosing schedule at an End-of-Phase
2 meeting with the FDA. Immuron will continue to collaborate with the Naval Medical Research Command and the Walter Reed Army Institute
of Research in the development of novel vaccines targeting Campylobacter and Shigella. Immuron has also advanced discussions with AFRIMS
to conduct testing of Travelan against EAEC and EPEC strains of E.coli.
Immuron launch PROIBS for
Irritable Bowel Syndrome (IBS)
Immuron announced the official
launch of PROIBS into the Australian market. Immuron has already received pharmacy orders for
the innovative product that treats the symptoms of medically diagnosed Irritable Bowel Syndrome (IBS). Immuron has been a leader in digestive
health in Australia for many years. PROIBS joined Immuron's product portfolio which includes
the rapidly growing Travelan brand building on the premium efficacy product range that will
deliver better outcomes for consumers that Pharmacists will love to recommend. PROIBS - to help