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Immuron (NASDAQ: IMRN) highlights Travelan growth and C. diff -529 program

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Rhea-AI Filing Summary

Immuron Limited provides an update via an investor presentation highlighting strong growth in its over-the-counter products and progress in its R&D pipeline. For FY 2025, global sales revenue reached $7.3m, up 49%, with Australian sales of $5.3m up 40% and North American sales of $2.0m up 76%. Gross profit margin was 65.4%, and EBITDA excluding R&D was a loss of $3.1m, a $2.1m improvement.

The company reports continued Travelan sales growth, with FY 2026 first-half global net sales of AUD$4.2m, up 5% year-on-year, driven mainly by Australia. Immuron notes FDA approval of the -529 IND for recurrent C. difficile infection and statistically significant Phase 2 results for Travelan, alongside updated peak U.S. sales expectations for -529 of US$400m from a consultancy. The outlook for FY 2026 includes continued year-on-year sales growth, progress toward EBITDA breakeven (excluding R&D), preclinical data for -986 in VRE, an end-of-Phase 2 meeting with the FDA for Travelan, and initiation of a Phase 2 trial for -529 in the first half of 2026.

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Insights

Immuron shows strong OTC sales growth and advances its C. diff pipeline, while still investing heavily in R&D.

Immuron reports FY 2025 global sales revenue of $7.3m, up 49%, with a healthy gross margin of 65.4%. Australian and North American revenues grew 40% and 76% respectively, indicating expanding demand for Travelan and related products. EBITDA excluding R&D was a loss of $3.1m, but this represents a $2.1m improvement, suggesting operating leverage as revenue scales.

On the pipeline, Immuron highlights FDA approval of the -529 IND for recurrent C. difficile infection and statistically significant Phase 2 results for Travelan. A consultancy has updated peak U.S. sales expectations for -529 to US$400m, underscoring perceived commercial potential, although this is not a guarantee of actual outcomes. FY 2026 objectives include further year-on-year sales growth, movement toward EBITDA breakeven (excluding R&D), preclinical data for -986 in VRE, an end-of-Phase 2 meeting with the FDA for Travelan, and initiation of a Phase 2 trial for -529 in the first half of 2026, so subsequent disclosures around these milestones will be important for assessing execution.

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 UNDER

THE SECURITIES EXCHANGE ACT OF 1934

 

For the Month of January 2026

 

Commission File Number: 001-38104

 

IMMURON LIMITED

(Name of Registrant)

 

Level 3, 62 Lygon Street, Carlton South, Victoria, 3053, Australia

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒       Form 40-F ☐

 

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

 

Yes ☐       No ☒

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-

 

 

 

 

 

IMMURON LIMITED

 

EXPLANATORY NOTE

 

Immuron Limited (the “Company”) published an announcement (the “Public Notices”) to the Australian Securities Exchange on January 23, 2026, titled:

 

    99.1 Emerging Growth Conference Presentation 

 

A copy of the Public Notice is attached as an exhibit to this report on Form 6-K.

 

This report on Form 6-K (including the exhibit hereto) shall not be deemed to be “filed” for purposes of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

1

 

EXHIBITS

 

Exhibit
Number
  Description
99.1   Emerging Growth Conference Presentation

 

2

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  IMMURON LIMITED
     
Date: January 23, 2026 By: /s/ Phillip Hains
    Phillip Hains
    Company Secretary

 

3

 

Exhibit 99.1

 

 

Immuron CEO, Steven Lydeamore presentation at Emerging Growth Conference

 

Melbourne, Australia, January 23, 2026: Immuron Limited (ASX: IMC; NASDAQ: IMRN) is pleased to advise our Chief Executive Officer, Steven Lydeamore presented virtually at the Emerging Growth Conference on Thursday 22nd January 2026 (2:40pm - 2:50pm U.S. Eastern Time).

 

A copy of the presentation made is included below.

 

This release has been authorised by the directors of Immuron Limited.

 

- - - END - - -

 

COMPANY CONTACT:

 

Steven Lydeamore

Chief Executive Officer

steve@immuron.com

 

About Immuron

 

Immuron Limited (ASX: IMC, NASDAQ: IMRN), is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases.

 

About Travelan®

 

Travelan® is an orally administered passive immunotherapy that prophylactically reduces the likelihood of contracting travelers’ diarrhea, a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce. Travelan® is a highly purified tabletized preparation of hyper immune bovine antibodies and other factors, which when taken with meals bind to diarrhea-causing bacteria and prevent colonization and the pathology associated with travelers’ diarrhea. In Australia, Travelan® is a listed medicine on the Australian Register for Therapeutic Goods (AUST L 106709) and is indicated to reduce the risk of Travelers’ Diarrhea, reduce the risk of minor gastro-intestinal disorders and is antimicrobial. In Canada, Travelan® is a licensed natural health product (NPN 80046016) and is indicated to reduce the risk of Travelers’ Diarrhea. In the U.S., Travelan® is sold as a dietary supplement for digestive tract protection.

 

Travelers’ diarrhea (TD)

 

TD is generally defined as the passage of ≥ 3 unformed stools per 24 hours plus at least one additional symptom (such as nausea, vomiting, abdominal cramps, fever, blood/mucus in the stools, or fecal urgency) that develop while abroad or within 10 days of returning from any resource-limited destinations (Leung et al., 2006). Diarrhea continues to be the most frequent health problem among travelers to destinations in lower- and middle-income regions (Steffen, 2017). Deployed US military personnel, essentially representing a long-term traveller population, are particularly affected given their population dynamics and the context in which they seek care and treatment (Connor et al., 2012). Diarrhea is the leading infectious disease threat to the overall health and preparedness of deployed US armed forces, with diarrheagenic E. coli, Campylobacter spp., and Shigella spp. among the most commonly reported etiologies (Riddle et al., 2006).

 

 

 

 

 

 

Immuron Platform Technology

 

Immuron’s proprietary technology is based on polyclonal immunoglobulins (IgG) derived from engineered hyper-immune bovine colostrum. Immuron has the capability of producing highly specific immunoglobulins to any enteric pathogen and our products are orally active. Bovine IgG can withstand the acidic environment of the stomach and is resistant to proteolysis by the digestive enzymes found in the Gastrointestinal (GI) tract. Bovine IgG also possesses this unique ability to remain active in the human GI tract delivering its full benefits directly to the bacteria found there. The underlying nature of Immuron’s platform technology enables the development of medicines across a large range of infectious diseases. The platform can be used to block viruses or bacteria at mucosal surfaces such as the Gastrointestinal tract and neutralize the toxins they produce.

 

IMM-124E (Travelan®)

 

IMM-124E was developed using Immuron’s platform technology. IMM-124E is produced from the colostrum of birthing cattle that have been immunised during pregnancy with a vaccine containing the outer antigens of multiple human derived ETEC. A total of 13 ETEC strains are used in the vaccine to produce high levels of antibodies against selected surface antigens from the most common strains of ETEC. (Otto et al., 2011)

 

The resultant hyperimmune colostrum IMM-124E from ETEC vaccinated cows contains significant levels of polyclonal antibodies specific for ETEC antigens LPS, CFA-I and Flagellin (Sears et al., 2017).

 

The antibodies produced in IMM-124E have been found to have a stronger binding and neutralizing activity (than the antibodies of unvaccinated cattle) against a wide range of LPS antigens including both the variable O-polysaccharide region and the preserved oligosaccharide core ‘R’ region of LPS from the 13 serotypes used in the ETEC vaccine.

 

IMM-124E is manufactured into a tablet form referred to as Travelan®.

 

IMM-529

 

Immuron is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention and/or treatment of recurrent Clostridioides difficile infection (CDI). IMM-529 antibodies targeting Clostridioides difficile (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%, P<0.0001; 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 (Hutton et al., 2017).

 

ProIBS®

 

Immuron has an exclusive distribution agreement with Calmino goup AB for the territories of Australia and New Zealand for ProIBS®. ProIBS® - to help patients treat IBS symptoms ProIBS® is a certified medical device for the treatment of IBS symptoms such as abdominal pain, bloating and unsettled bowel movements (diarrhoea and/or constipation). ProIBS® contains AVH200®, derived from the plant Aloe barbadensis. Mill. AVH200® has gel forming components which support the intestinal mucosal barrier. As IBS is known to affect individuals for a long period of time, it is essential to have a treatment appropriate for long-term use –as ProIBS® is. The product is safe, and no interactions with other medications are known. Science-driven innovative Calmino group AB, the developer of ProIBS®, conducted a usability study among 1,003 users. PROIBS® was helpful for 94% of them. 91% of the users experienced an improvement in daily life and 98% would recommend PROIBS® to someone else. To learn more please check: www.proibs.eu.

 

 

 

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Irritable bowel syndrome (IBS) is a common condition where you experience symptoms related to your digestive system. This is sometimes linked to certain foods, lifestyle habits and stress levels or mood. IBS affects around 3 out of every 10 people. Females are more likely than males to be affected. Some key symptoms of IBS include: abdominal pain or discomfort; stomach bloating and wind; chronic diarrhoea or constipation, or alternating between the two.(healthdirect.gov.au) According to available data, the IBS treatment market in Australia is estimated to be a part of the broader “Digestives & Intestinal Remedies” market, generating a revenue of around AU$221.14 million in 2025, with a projected annual growth rate of 3.28%.(Statista)

 

References

 

Connor P, Porter CK, Swierczewski B and Riddle MS. Diarrhea during military deployment: current concepts and future directions. Curr Opin Infect Dis. 25(5): 546-54; 2012.

 

Hutton, M.L., Cunningham, B.A., Mackin, K.E. et al. Bovine antibodies targeting primary and recurrent Clostridium difficile disease are a potent antibiotic alternative. Sci Rep 7, 3665 (2017). https://doi.org/10.1038/s41598-017-03982-5

 

Leung AK, Robson WL, Davies HD. Travelers’ diarrhea. Adv Ther. Jul-Aug; 23(4): 519-27; 2006

 

Otto W, Najnigier B, Stelmasiak T and Robins-Browne RM. Randomized control trials using a tablet formulation of hyperimmune bovine colostrum to prevent diarrhea caused by enterotoxigenic Escherichia coli in volunteers Scandinavian Journal of Gastroenterology 46: 862– 868; 2011.

 

Riddle MS, Sanders JW, Putnam SD, and Tribble DR. Incidence, etiology, and impact of diarrhea among long-term travelers’ (US military and similar populations): A systematic review. American Journal of Tropical Medicine and Hygiene. 74(5): 891-900; 2006.

 

Sears KT, Tennant SM, Reymann MK, Simon R, Konstantopolos N, Blackwelder WC, Barry EM and Pasetti MF. Bioactive Immune Components of Anti-Diarrheagenic Enterotoxigenic Escherichia coli Hyperimmune Bovine Colostrum products. Clinical and Vaccine Immunology. 24 (8) 1-14; 2017.

 

Steffen R. Epidemiology of travelers’ diarrhea. J Travel Med. 24(suppl_1): S2-S5; 2017.

 

For more information visit: https://www.immuron.com.au/ and https://www.travelan.com

 

Subscribe to Immuron’s InvestorHub: Here

 

FORWARD-LOOKING STATEMENTS:

 

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

 

 

3

 

EMERGING GROWTH CONFERENCE 23 JANUARY 2026 NASDAQ: IMRN ASX: IMC

 

 

2 Certain statements made in this presentation are forward - looking statements and are based on Immuron’s current expectations, estimates and projections. Words such as ” anticipates,” “expects,” “intends,” “plans,” “believes,” ” seeks,” “estimates,” “guidance” and s imilar expressions are intended to identify forward - looking statements. Although Immuron believes the forward - looking statements are based on reasonable assumptions, they are subject to certain r i sks and uncertainties, some of which are beyond Immuron’s control, including those r i sks or uncertainties inherent in the process of both developing and commercializing technology. As a result, actual results could materially differ f rom those expressed or forecasted in the forward - looking statements. The forward - looking statements made in this presentation relate only to events as of the date on which the statements are made. Immuron will not undertake any obligation to release publicly any revisions or updates to these forward - looking statements to reflect events, circumstances or unanticipated events occurring after the date of this presentation except as required by l aw or by any appropriate regulatory authority. FY 2026 results in this presentation are subject to audit review. SAFE HARBOR STATEMENT

 

 

Immuron Ltd is an Australian integrated biopharmaceutical company with global scale, focused on developing, and commercialising, oral products for the treatment of gut mediated diseases Research & Development 3 pipeline assets in 2 clinical programmes Global footprint Australia, US, Canada and expanding Technology Platform Safe and potentially transformational approach to gut infections Our Products • Reduce the risk of Traveller’s Diarrhoea • Sold in pharmacies Australia - wide • Available in Australia, USA and Canada • Treatment of symptoms associated with Irritable Bowel Syndrome (IBS) • To be sold in pharmacies Australia - wide • Available in Australia NEW • Proprietary technology based on generating hyper - immune bovine colostrum that is rich in polyclonal antibodies also known as immunoglobulins. • Bovine antibodies also possess the unique ability to remain active in the human GI tract where they target enteric pathogens. • The underlying nature of our platform technology enables the development of medicines across a large range of infectious diseases. • The platform can be used to generate bovine antibodies that block viruses or bacteria at mucosal surfaces in the Gastrointestinal tract and neutralize the toxins they produce. Technology Platform Corporate Research I ndependent Buy recommendation

 

 

FY25 Financial Achievements Global Sales Revenue $7.3m Up 49% Australian Sales Revenue $5.3m Up 40% North American Sales Revenue $2.0m Up 76% Gross Profit Margin 65.4% EBITDA (ex - R&D) 1 $(3.1)m $2.1m improvement Cash + Term Deposit 2,3 $5.9m 4 1 ex - R&D: add back research & development, less R&D Tax Incentive and R&D grants; 2 30 June 2025, as reported in Immuron’s Appendix 4E (Cash $2.83m; Term Deposit $3.04m); 3 Since 30 June 2025, Immuron has raised, cost - effectively, A$7.15m from the US At - The - Market facility.

 

 

Travelan® continued strong sales growth Global + FY2025 AUD$7.3 million up 49% on prior year + FY2026 H1 AUD$4.2 million up 5% on FY2025 H1 Australia + FY2025 AUD$5.2 million up 40% on prior year + FY2026 H1 AUD$3.3 million up 13% on FY2025 H1 North America + FY2025 AUD$2.0 million up 76% on prior year + FY2026 H1 AUD$0.9 million down 18% on FY2025 H1 + USA FY2026 H1 AUD$0.9 million up 17% on FY2026 H1 $ - $1,000,000 $4,000,000 $3,000,000 $2,000,000 $5,000,000 $6,000,000 $7,000,000 $8,000,000 Jul - Sep Oct - Dec Jan - Mar Apr - Jun Global Year to Date Net Sales ($AUD) FY24 5 FY25

 

 

FY25 Clinical Achievements and Operational Highlights FDA approval IMM - 529 IND Travelan® n= 851 trial completed Travelan® Ph 2 statistically significant results 1 New research collaboration IMM - 986 (VRE) New product launch in Australia Updated peak U.S. sales for IMM - 529 US$400 million 2 1. Immunology results and Microbiome responses; 2. Lumanity global healthcare consulting 6

 

 

FY26 Outlook Continued YoY sales growth Progression towards EBITDA (ex - R&D) 1 breakeven IMM - 986 (VRE) Pre - clinical data 1H 2026 Travelan ® End of Phase 2 Meeting with FDA 1H 2026 IMM - 529 Initiation of Phase 2 1H 2026 1 ex - R&D: add back research & development, less R&D Tax Incentive and R&D grants 7

 

 

STEVEN LYDEAMORE CHIEF EXECUTIVE OFFICER IMMURON LIMITED CONTACT INFORMATION: EMAIL: STEVE@IMMURON.COM PHONE: AUSTRALIA: +61 438 027 172 IMMURON I NVESTOR HUB COMMUNICATION AND CONTENT INCLUDING ANNOUNCEMENTS AND CORPORATE RESEARCH

 

FAQ

What did Immuron (IMRN) report about its FY 2025 sales performance?

Immuron reported FY 2025 global sales revenue of $7.3m, an increase of 49% on the prior year. Australian sales were $5.3m, up 40%, and North American sales were $2.0m, up 76%.

How profitable were Immurons operations before R&D in FY 2025?

Immuron reported a FY 2025 EBITDA loss excluding R&D of $3.1m, which represented a $2.1m improvement compared with the prior period. The gross profit margin for the year was 65.4%.

What recent regulatory progress did Immuron (IMRN) achieve for its -529 program?

Immuron states that the U.S. FDA approved the -529 Investigational New Drug (IND) application for recurrent Clostridioides difficile infection. The company also cites updated peak U.S. sales expectations for -529 of US$400m from Lumanity global healthcare consulting.

How is Travelan performing and what are Immurons recent clinical results?

Travelan global sales in FY 2025 were AUD$7.3m, up 49% year-on-year, and FY 2026 first-half global sales were AUD$4.2m, up 5% on the prior corresponding period. Immuron reports that a Phase 2 trial of Travelan produced statistically significant results, including immunology and microbiome responses.

What are Immurons key goals for FY 2026?

For FY 2026, Immuron highlights goals of continued year-on-year sales growth, progression toward EBITDA breakeven excluding R&D, preclinical data for -986 in vancomycin-resistant Enterococcus (VRE) in the first half of 2026, an end-of-Phase 2 FDA meeting for Travelan in the first half of 2026, and initiation of a Phase 2 trial for -529 in the first half of 2026.

What cash resources and recent financing did Immuron disclose?

As of 30 June 2025, Immuron reported cash of $2.83m and term deposits of $3.04m, totaling $5.9m. Since that date, the company has raised an additional A$7.15m through a U.S. at-the-market facility.

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