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Immuron (IMRN) lifts FY26 sales as it shifts to partner-funded drug development

(Neutral)
(Neutral)
Form Type
6-K

Rhea-AI Filing Summary

Immuron Ltd (IMRN) provided an investor presentation outlining its FY2026 performance and partnering-focused strategy. FY2026 global sales revenue was A$7.7 million, up 6% year on year, with Australian sales of A$5.8 million (up 10%), U.S. sales of A$1.8 million (up 7% and 13% in USD) and Canadian sales of A$0.2 million (down 55%). Cash was A$10.0 million as of 31 December 2025.

The company is repositioning as a commercially focused biopharmaceutical business with over-the-counter products Travelan and ProIBS while seeking partners for its clinical assets IMM-124E (Travelan for traveler’s diarrhea) and IMM-529 (Clostridioides difficile infection). IMM-124E is eligible for an end-of-Phase 2 FDA meeting, and IMM-529 has an FDA-approved investigational new drug application to proceed to Phase 2. Management plans to have licensees fund development and commercialization in exchange for upfront fees, milestones and royalties, aiming to reduce R&D spend and cash burn while maintaining recurring OTC revenue.

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FY2026 Global Sales Revenue A$7.7 million FY2026, 6% year-on-year increase
FY2026 Australian Sales A$5.8 million FY2026, up 10% on prior year
FY2026 U.S. Sales A$1.8 million FY2026, up 7% year on year; up 13% in USD
FY2026 Canada Sales A$0.2 million FY2026, down 55% on prior year
Cash Balance A$10.0 million As of 31 December 2025
EBITDX (ex-R&D) -A$1.1 million HY26, compared with HY25 and 2H FY25
R&D Tax Incentive A$1.1 million Received in February 2026
Shares on Issue 322,848,081 Ordinary shares outstanding
hyperimmune bovine colostrum medical
"IMM-529 is an oral, non-systemic biological (hyperimmune bovine colostrum)"
Hyperimmune bovine colostrum is the first milk produced by cows that have been vaccinated or otherwise exposed to a specific pathogen so their colostrum is unusually rich in antibodies against that target. Think of it as a concentrated, natural antibody extract collected from cows and used as a passive immune therapy or ingredient in supplements and medical products. It matters to investors because its value depends on demonstrated clinical benefit, manufacturing scale, regulatory approvals, and market demand for targeted antibody products.
investigational new drug (IND) application regulatory
"IMM-529 has an investigational new drug (IND) application approved by the U.S. FDA"
An investigational new drug (IND) application is a formal request submitted to a drug regulator asking permission to begin testing a new medicine in people. It compiles lab results, manufacturing details and proposed human trial plans so regulators can judge safety before human studies start; for investors, an accepted IND is a key milestone that opens the clinical development pathway and can materially change a company’s risk profile and potential value, like getting a license to road-test a prototype.
EBITDX (ex-R&D) financial
"EBITDX (ex-R&D)1 for HY26 was -A$1.1m"
Serviceable Obtainable Market financial
"SOM (Serviceable Obtainable Market): The peak revenue based on Immuron capturing 30%"
Total Addressable Market financial
"TAM (Total Addressable Market): 100% of all recurrent CDI patients globally"
Total addressable market is the total potential sales opportunity for a product or service if it were to reach every possible customer. It helps investors understand the maximum size of the market and the growth potential for a business. Think of it as the entire pie available to be shared, indicating how big the opportunity could be.
end of Phase 2 meeting regulatory
"IMM-124E is eligible for an end of Phase 2 meeting with the U.S. FDA"

FAQ

What were Immuron (IMRN) FY2026 global sales and growth?

Immuron reported FY2026 global sales of A$7.7 million, representing a 6% year-on-year increase. Growth was driven mainly by Australia and the U.S., partly offset by weaker Canadian sales in the period.

How did Immuron (IMRN) perform by region in FY2026?

In FY2026, Australia generated A$5.8 million in sales (up 10%), the U.S. A$1.8 million (up 7%; 13% in USD), and Canada A$0.2 million (down 55%). This shows solid performance in core markets with a decline in Canada.

What is Immuron (IMRN) disclosing about its cash position and runway?

Immuron reported cash of A$10.0 million as of 31 December 2025. Management links this balance to funding commercial operations, including over-the-counter sales of Travelan and ProIBS, while pursuing partnering for its clinical assets.

What is Immuron’s strategy for its clinical assets IMM-124E and IMM-529?

Immuron plans to partner IMM-124E and IMM-529 for development and commercialization. Under this model, licensees typically fund clinical and registration costs and pay Immuron upfront fees, milestones and royalties, reducing Immuron’s direct R&D burden.

What regulatory milestones has Immuron (IMRN) reached for IMM-124E and IMM-529?

IMM-124E (Travelan for traveler’s diarrhea) is eligible for an end-of-Phase 2 FDA meeting, and IMM-529 for Clostridioides difficile infection has an FDA-approved IND to proceed to Phase 2 clinical trials.

What products currently generate commercial revenue for Immuron (IMRN)?

Immuron’s commercial revenue comes from Travelan, which reduces the risk of traveler’s diarrhea, and ProIBS, used for irritable bowel syndrome symptoms. Both are sold through pharmacies, with Travelan available in Australia, the U.S. and Canada.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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 August 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 August 19, 2026 titled:

 

  - 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: August 19, 2026 By: /s/ Olga Smejkalova
    Olga Smejkalova
    Company Secretary

 

3

 

Exhibit 99.1

 

 

Immuron CEO, Steven Lydeamore presentation at

Emerging Growth Conference

 

Melbourne, Australia, August 19, 2026: Immuron Limited (ASX: IMC; NASDAQ: IMRN) is pleased to advise our Chief Executive Officer, Steven Lydeamore is presenting at the Emerging Growth Conference on Wednesday 19th August 2026 (4:25pm – 4:35pm U.S. Eastern Time).

 

A copy of the presentation being 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.

 

 

 

 

 

 

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.

 

 

 

 

 

19 August 2026 Steven Lydeamore Chief Executive Officer Investor Presentation NASDAQ: IMRN ASX: IMC

 

 

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 similar 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 risks and uncertainties, some of which are beyond Immuron's control, including those risks or uncertainties inherent in the process of both developing and commercializing technology. As a result, actual results could materially differ from 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 law or by any appropriate regulatory authority. SAFE HARBOR STATEMENT FY2026 results in this presentation are subject to audit review.

 

 

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 2 pipeline assets to be partnered for development and commercialization 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) • Sold in pharmacies Australia-wide • Immuron's core strength lies in its ability to program cows to produce high levels of specific polyclonal antibodies (immunoglobulins) through vaccination. • Orally Active: Unlike many biologics that require injection, Immuron's bovine antibodies are naturally hardy. They survive the harsh acidic environment of the human stomach to work directly in the Gastrointestinal (GI) tract. • Precision Targeting: The platform can be "tuned" to target specific bacteria, viruses, or toxins by changing the vaccine. • Dual-Action Mechanism: The products don't just target the pathogens; they prevent them from sticking to the gut wall and neutralize the inflammatory toxins they release. • No reported serious adverse events or safety signals. Safety demonstrated in repeat-dose animal toxicity studies, immunohistochemical assessments showing no off-target cross-reactivity and bacterial reverse-mutation testing confirming it is non- mutagenic. Technology Platform Corporate Research Independent Buy recommendation

 

 

4 FY26 Global Sales Revenue of A$7.7 million up 6% on prior year FY26 Australian Sales of A$5.8 million, up 10% FY26 U.S. Sales of A$1.8 million, up 7%; up 13% in USD FY26 Canada Sales of A$0.2 million, down 55% EBITDX (ex-R&D)1 for HY26 was -A$1.1m, up A$0.1m on HY25 and up A$0.7m on 2H FY25 Cash of A$10.0 million, up A$7.2 million on 30 June 2025; equivalent to 22.5 months of cash used in operating activities in 1H FY26 R&D Tax Incentive A$1.1 million received in February 2026 FY 26 Sales Results Executive summary Immuron Ltd (NASDAQ:IMRN) (ASX:IMC) is a globally integrated biopharmaceutical company focused on developing, and commercialising, oral immunotherapeutics for the treatment of gut mediated diseases Two commercial products: Travelan® (traveler's diarrhea and ProIBS (irritable bowel syndrome) Two clinical assets: Travelan®: IMC: eligible for end of Phase 2 meeting with U.S. FDA IMM-529 (CDI): U.S. FDA investigational new drug (IND) application approval to proceed with Phase 2 clinical trial Major Shareholders Financial Snapshot Shares on Issue 322,848,081 Total Options 11,767,491 Last Traded Price IMC: A$0.039 52 week High/Low IMC: A$0.098/0.026 IMRN: $2.39/0.677 Market Cap IMC: A$12.59m Cash (31 December 2025) A$10.0m Holder Units % of CSO BNY Mellon Asset Management 144,292,904 44.73 % Board and Employees 6,566,869 2.03% Dr Russell Hancock 6,000,000 1.86 % Karma Wealth Pty Ltd 6,000,000 1.86 % Company Overview Commercial: Four consecutive quarters of Travelan® sales in FY26 exceeding prior year July 2026: Pullan Consulting engaged to support partnering IMM-529 Clinical: IMM-529 (CDI): U.S. FDA approval of investigational new drug (IND) application in November 2025. Uniformed Services University IMM-124E trial reported topline results in December 2025; secondary analysis pending. New research agreement signed in December 2025 funded by a U.S. Department of Defense sub award with the Naval Medical Research Command and Walter Reed Army Institute of Research. First revenue received in May 2026. Business Update 1 Earnings before Interest, Tax, Depreciation, Foreign Exchange and Net R&D (R&D expenses less R&D income) HY 26 Results

 

 

5 Continued strong sales growth Global + FY2026 AUD$7.7 million up 6% on prior year Australia + FY2026 AUD$5.8 million up 10% on prior year North America + FY2026 AUD$1.9 million down 5% on prior year + USA FY2026 AUD$1.8 million up 7% on prior year; up 13% in USD + Canada FY2026 AUD$0.2 million down 55% on prior year; up 376% in 4Q FY2026

 

 

6 Immuron strategic reset provides clearer path to profitability Immuron has taken a strategic decision to partner clinical assets IMM-124E and IMM-529 for development and commercialization. • IMM-124E is eligible for an end of Phase 2 meeting with the U.S. FDA (indication: traveler's diarrhea) • Lumanity1 peak U.S. sales estimate of US$102 million • IMM-529 has an investigational new drug (IND) application approved by the U.S. FDA and is ready to go into Phase 2 clinical trials (indication: Clostridioides difficile infection) • Lumanity1 peak U.S. sales estimate of US$400 million • Under a partnering model, the licensee typically funds development, registration and commercialization costs and pays the licensor an upfront licensing fee, milestone payments and royalties on sales • This partnering strategy removes the uncertainty of how Immuron would fund these assets through to commercialization • Partnering has the potential to bring forward monetization of these assets • The reduction in R&D expenses (net of R&D Tax Incentive) will improve profitability and decrease cash burn • Immuron has sufficient cash ($10 million @ 31 December 2025) to fund commercial operations (over the counter (OTC) sales of Travelan® and PROIBS® • Immuron continues to evaluate opportunities to broaden distribution and to add complementary products to its OTC portfolio 1. Lumanity global healthcare consulting

 

 

7 IMM-529: A First-in-Class Triple-Action CDI Biologic The Opportunity: IMM-529 is an oral, non-systemic biological (hyperimmune bovine colostrum) for treatment and prevention of primary and recurrent Clostridioides difficile infection (CDI). Unlike antibiotics, IMM-529 eliminates the pathogen without disrupting the gut microbiome, directly addressing the root cause of CDI disease recurrence. Key Highlights: 1. Unique Triple-Action Mechanism: The only asset in clinical development that simultaneously targets all 3 drivers of CDI: Toxin B, Vegetative Cells & Spores 2. Exceptional Pre-clinical Efficacy: o Prevention: ~80% survival rate without antibiotics o Treatment: ~80% survival rate (comparable to vancomycin) o Relapse: ~90% survival rate (vs. 11-22% in controls) 3. Microbiome Preservation: IMM-529 does not destroy gut flora, allowing the microbiome to recover while neutralizing the infection—a critical advantage over standard-of-care antibiotics 4. Broad Strain Reactivity: Multi-strain effective including hypervirulent strains (027 and 078 ribotypes) 5. Clinical Readiness: FDA IND approved for Phase 2 clinical study

 

 

8 IMM-529 Market Potential The Disease: C. difficile is the leading cause of healthcare-associated infection causing 400,000 cases and 30,000 deaths in the US annually Disease spectrum: • Mild-to-moderate: Watery persistent diarrhea, cramping • Severe/Pseudomembranous Colitis (PMC): Colon wall plaques • Fulminant CDI: Toxic megacolon, sepsis, and potential bowel perforation, death Who's at risk: Adults 65+, immunocompromised patients, antibiotic users, and Proton Pump Inhibitors users. Problem with current treatment: Antibiotics eliminate pathogens, indiscriminately disrupt the gut microbiome, hinder flora regeneration, and leave 25% patients vulnerable to recurrent infection within 30 days, rising to 65% after multiple episodes Market opportunity: The diagram represents the funnel from the clinical burden to Immuron's target revenue: • TAM (Total Addressable Market): 100% of all recurrent CDI patients globally at regional pricing. • SAM (Serviceable Addressable Market): The subset of patients expected to be treated with advanced therapy (e.g., FMT, Vowst, Rebyota, or IMM-529). • SOM (Serviceable Obtainable Market): The peak revenue based on Immuron capturing 30% of the advanced therapy segment.

 

 

9 IMM-529 Deal Potential Year Licensor / Asset Owner Licensee / Acquirer Licensed Asset Financial terms (public) Stage at deal Status update (as of March 2026) 2024 Seres Therapeutics Nestlé Health Science VOWST (SER-109) business (oral microbiota spores) Asset sale signed Aug 2024 (public reporting indicates deal structure included upfront and additional payments; exact totals vary by source and filings). (BioSpace) Marketed FDA approved (Apr 2023) and commercialized by Nestlé Health Science; global rights consolidated under Nestlé via the 2024 transaction. (U.S. Food and Drug Administration) 2023 Destiny Pharma Sebela Pharmaceuticals NTCD-M3 (non toxigenic C. difficile strain, live biotherapeutic) Upfront $1M; up to $570M milestones (incl. $19M development and up to $550M sales) plus royalties. (FT Markets) Phase 3 ready Phase 3 preparation continues, including work on a more patient friendly capsule formulation and regulatory alignment on Phase 3 design. (AMR Bio) 2021 Seres Therapeutics Nestlé Health Science SER-109 (later VOWST) $175M upfront; $125M on FDA approval; up to $225M sales milestones; profit share structure. (Business Wire) Phase 3 Became FDA approved Apr 2023; subsequently commercialized and later moved into the 2024 asset sale to Nestlé (row above). (U.S. Food and Drug Administration) 2018 Rebiotix Ferring Pharmaceuticals RBX2660 (later REBYOTA), microbiota suspension Acquisition (terms not fully disclosed publicly). (Ferring Global) Phase 3 FDA approved Nov 2022 for prevention of recurrent CDI; marketed as REBYOTA. (Ferring Global) 2017 Summit Therapeutics Eurofarma Ridinilazole (small molecule antibiotic) $2.5M upfront; up to $25M milestones plus royalties. (BioSpace) Phase 2/3 Phase 3 program did not meet superiority vs vancomycin; Summit later focused its strategy on oncology (ivonescimab). (Fierce Biotech) 2017 Assembly Biosciences Allergan (later AbbVie) Microbiome GI programs (often cited as ABI-M201, ABI- M301; not CDI specific) $50M upfront plus milestones and royalties (per deal announcement coverage). (BioSpace) Preclinical Partnership was later unwound and the microbiome candidates returned; Assembly ultimately exited microbiome work. Note: public deal descriptions emphasize UC and Crohn's, not CDI. (Fierce Biotech)

 

 

IMMURON LIMITED (ASX:IMC / Nasdaq:IMRN) | Institutional Investor Snapshot FY2026 Revenue A$7.7m FY26 +6% YoY Market Cap. A$10.7m 10 August 2026 Cash A$10.0m @31 Dec 26 ; 24-month runway Pipeline 2 Assets Partnering focus Investment Thesis • Commercial-stage biotech with recurring OTC revenue • Proprietary Hyper-Immune technology platform • Dual value drivers: sales growth + licensing potential • Strategic reset aimed at profitability and reduced cash burn Catalysts (12-18 months) Q1: Continued Travelan growth Q2: Portfolio expansion Q3: IMM-529 partnering progress Q4: Geographic expansion and EBITDX ex- R&D1 improvement Risk / Reward Assessment LOW: Cash runway MEDIUM: Sales execution HIGH UPSIDE: IMM-529 licensing event TRANSFORMATIONAL: Upfront + milestone deal economics Investor Conclusion Immuron is a company transitioning from development-led to commercially focused growth. Revenue trends remain positive, cash is sufficient to support operations, and management is seeking external partners for IMM-529 and Travelan® to unlock value while limiting funding risk. The principal valuation catalyst is a successful transaction for IMM-529, which management highlights as a potentially large market opportunity (Clostridioides difficile infection; Lumanity peak sales estimate in the U.S. US$400 million). 1. Earnings before Interest Tax Depreciation and FX and ex-R&D: Research & Development expenses, R&D Tax Incentive and R&D grants

 

 

EMAIL: STEVE@IMMURON.COM PHONE: AUSTRALIA: +61 438 027 172 STEVEN LYDEAMORE CHIEF EXECUTIVE OFFICER IMMURON LIMITED CONTACT INFORMATION:

 

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