Immuron signs US deal for PROIBS gut health launch

Immuron Limited is expanding its digestive health portfolio by securing exclusive U.S. distribution rights for PROIBS® from Calmino group AB.

Rhea-AI Filing Summary

Immuron Limited (IMRN) has executed an exclusive distribution agreement with Sweden-based Calmino group AB to launch PROIBS® in the United States. PROIBS®, already launched by Immuron in Australia during FY26, targets part of the U.S. digestive/gut health supplement market, which is valued at $4.16 billion.

PROIBS® is described as a medical device for abdominal pain, bloating and unsettled bowel movements, containing AVH200® from Aloe barbadensis Mill to support the intestinal mucosal barrier and suitable for long-term use. Calmino’s usability study of 1,003 users reported that 94% found PROIBS® helpful, 91% saw improvement in daily life and 98% would recommend it. Immuron positions this agreement as part of a broader commercial growth strategy to expand its digestive health portfolio beyond Travelan®.

Key Figures

U.S. digestive/gut health supplement market size: $4.16 billion PROIBS® usability study participants: 1,003 users Users finding PROIBS® helpful: 94% +3 more

6 metrics

U.S. digestive/gut health supplement market size $4.16 billion Overall market size cited as the space Immuron is targeting with PROIBS®

PROIBS® usability study participants 1,003 users Number of users in Calmino group AB’s usability study of PROIBS®

Users finding PROIBS® helpful 94% Percentage of study participants who found PROIBS® helpful

Users reporting improved daily life 91% Percentage of study participants reporting improvement in daily life with PROIBS®

Users who would recommend PROIBS® 98% Percentage of study participants who would recommend PROIBS® to someone else

Year PROIBS® launched by Immuron in Australia FY26 Financial year when Immuron launched PROIBS® in the Australian market

Key Terms

exclusive distribution agreement, medical device, intestinal mucosal barrier, polyclonal antibodies, +2 more

6 terms

exclusive distribution agreement financial

"executed an exclusive distribution agreement for PROIBS® in the United States"

A contract in which a manufacturer or rights holder gives one distributor the sole right to sell a product or service in a particular territory or channel. For investors, it matters because exclusivity can boost predictable sales, margin stability and market reach for the parties involved, but it also concentrates risk—if the distributor underperforms or the agreement ends, revenue can drop sharply. Think of it like appointing a single shop to be the only place in town to sell a popular item.

medical device medical

"PROIBS® is a medical device used for abdominal pain, bloating"

Tools, instruments, or machines used to diagnose, treat or monitor health conditions—ranging from simple items like bandages and thermometers to complex machines such as imaging scanners or implantable devices. Investors care because a device’s safety, effectiveness, and approval by health regulators affect sales, legal risk and ongoing costs; think of a medical device like a new appliance whose market success hinges on reliable performance, safety reviews and customer adoption.

intestinal mucosal barrier medical

"gel forming components which support the intestinal mucosal barrier"

The intestinal mucosal barrier is the layered lining of the gut made up of epithelial cells, tight junctions, mucus, and associated immune components that keeps digestive contents and microbes separate from the body’s interior. It matters to investors because its integrity is central to many gastroenterology drugs, biologics, diagnostics and safety assessments: treatments that restore or cross this barrier can determine clinical effect, regulatory outcomes and market value for healthcare companies.

polyclonal antibodies medical

"commercializing orally delivered targeted polyclonal antibodies for the treatment"

A polyclonal antibody preparation is a mixture of immune proteins collected from multiple cells that recognize different parts of the same target, so it attacks a target in several complementary ways rather than one narrowly focused spot. For investors, that means such products can be quicker to develop and more resilient against small changes in a target, but they can also pose manufacturing, consistency and regulatory challenges that affect clinical success, costs and product scalability.

forward-looking statements regulatory

"This press release may contain “forward-looking statements” within the meaning"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

life science company technical

"Calmino group AB is a Swedish life science company founded in 2003"

FAQ

What did Immuron Limited (IMRN) announce in this Form 6-K?

Immuron Limited announced it has executed an exclusive distribution agreement with Calmino group AB to launch the digestive health product PROIBS® in the United States, expanding on its prior launch of PROIBS® in Australia during FY26.

How large is the U.S. market Immuron (IMRN) is targeting with PROIBS®?

Immuron cites the overall U.S. digestive/gut health supplement market as being valued at $4.16 billion. The company indicates it is targeting a subset of this broader market with PROIBS®.

What is PROIBS® and what condition does it address for Immuron (IMRN)?

PROIBS® is described as a medical device used for abdominal pain, bloating and unsettled bowel movements, including diarrhoea and constipation. It contains AVH200®, derived from Aloe barbadensis Mill, with gel-forming components that support the intestinal mucosal barrier.

What user outcomes were reported for PROIBS® in Calmino’s study mentioned by IMRN?

Calmino group AB conducted a usability study among 1,003 users. According to the disclosure, PROIBS® was helpful for 94%, 91% experienced improvement in daily life, and 98% said they would recommend the product to someone else.

How does PROIBS® fit into Immuron’s (IMRN) broader commercial strategy?

Immuron’s Chief Commercial Officer said that, following rapid U.S. sales growth of Travelan®, the company’s strategy is to bring a portfolio of innovative digestive health products to market, and PROIBS® is presented as a key opportunity to expand this portfolio.

Who is Immuron’s partner for PROIBS® and what is their background?

Immuron’s partner is Calmino group AB, a Swedish life science company founded in 2003 and based at Sahlgrenska Science Park in Gothenburg. Calmino develops and commercializes science-driven digestive health products, and its lead product PROIBS® has been sold in European markets for more than a decade.

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

Form 6-K: How Foreign Companies Report to the SEC →

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Available on EDGAR 09/04/2026 - 06:07 AM Accepted by SEC EDGAR 09/03/2026 - 08:38 PM Learn about SEC filing dates

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 September 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 September 04, 2026, titled:

- PROIBS US Distribution Agreement

A copy of the Public Notices 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		PROIBS US Distribution Agreement

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: September 04, 2026	By:	/s/ Olga Smejkalova
		Olga Smejkalova
		Company Secretary

3

Exhibit 99.1

Immuron to launch PROIBS® in the United States

Melbourne, Australia, September 4, 2026: Immuron Limited (ASX: IMC; NASDAQ: IMRN) is pleased to announce that it has executed an exclusive distribution agreement for PROIBS® in the United States with Calmino group AB. Immuron launched PROIBS® in Australia during FY26.

The overall U.S. digestive/gut health supplement market is valued at $4.16 billion (Mordor Intelligence). Immuron is targeting a subset of this market with PROIBS®. PROIBS® is a medical device used for 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. PROIBS® is suitable for long-term use, with an excellent safety profile and no interactions with other medications 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.

Flavio Palumbo, Chief Commercial Officer said “Following the rapid growth of Travelan® sales in the US, we have developed a commercial growth strategy to bring a portfolio of innovative digestive health products to market. PROIBS® is a great opportunity to further expand our digestive health portfolio by providing our customers with a proven premium product that delivers improvement in daily life. With PROIBS®, we are able to provide an innovative and European certified medical device. The product has been on the Swedish pharmacy market for more than a decade. Because it is backed by science and recommended by physicians and dietitians, we can promote PROIBS® with absolute confidence. We are looking forward to offering a solution that truly improves the livability of the affected people.”

Tobias Kisker, CEO and founder of Calmino group AB, commented “We are immensely proud to further expand our collaboration with Immuron. What started with PROIBS® in Australia is now developing into a partnership across two continents, with the United States becoming our next important market together. We look forward to building on the strong relationship we have established with Immuron.”

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.

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

Subscribe to Immuron’s InvestorHub: Here

About Calmino group AB

Calmino group AB is a Swedish life science company founded in 2003 and based at Sahlgrenska Science Park in Gothenburg, Sweden. The company develops and commercializes science-driven products within digestive health. Its lead product, PROIBS®, has been available in European markets for more than a decade and is currently distributed internationally.

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.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PROIBS US DISTRIBUTION AGREEMENT 11.3 KB