Immuron Letter to Shareholders: Projects Update

Rhea-AI Summary

Immuron (NASDAQ: IMRN) reported significant progress across multiple projects in their latest shareholder update. The company is set to exceed A$7 million in sales for the current financial year, marking a substantial increase from A$4.9 million in the previous year. Key developments include: the completion of recruitment for the Travelan® field study with topline results expected in October 2025, anticipated IMM-529 IND submission to FDA in August 2025 for Clostridioides difficile infection treatment, upcoming launch of ProIBS® in Australia with product delivery expected in Q3 2025, and pre-clinical research results for IMM-986 targeting Vancomycin-resistant enterococci due in August 2025. The company's IMM-124E has a projected base case yearly revenue of US$102 million in the USA, while IMM-529 could reach peak revenues of approximately US$400 million.

Positive

• Record-breaking sales with projected A$7 million this financial year, up from A$4.9 million previous year
• IMM-124E (Travelan®) has projected base case yearly revenue of US$102 million in USA
• IMM-529 market potential estimated at US$400 million peak revenues in the US
• Multiple revenue streams in development with three therapeutic products: IMM-124E, IMM-529, and IMM-986
• Entry into Australian IBS market through ProIBS® distribution agreement, targeting A$221 million market

Negative

• Final results for Travelan® clinical study not expected until October 2025
• IMM-529 still pending FDA IND submission and approval
• ProIBS® launch delayed until Q1 2026
• IMM-986 still in early pre-clinical research phase

Insights

Biopharmaceutical Industry Analyst

Immuron reports record sales trajectory and critical development milestones across multiple therapeutic programs with significant market potential.

Immuron's operational update demonstrates strong commercial momentum with projected annual sales exceeding A$7 million for FY2025, representing a substantial 42.9% increase from A$4.9 million in the previous year. This sales acceleration validates their commercial strategy and provides crucial non-dilutive funding.

The company's pipeline development is progressing systematically across three key therapeutic candidates:

• IMM-124E (Travelan®): The Uniformed Services University clinical study has completed recruitment with topline results expected in October 2025. Success could position Travelan® for inclusion in traveler's diarrhea guidelines, potentially expanding its US market opportunity to an estimated US$102 million annually.
• IMM-529: Development for Clostridioides difficile infection is advancing toward FDA IND submission in August 2025, targeting a substantial market with estimated peak US revenues of US$400 million.
• IMM-986: The pre-clinical research collaboration with Monash University targeting Vancomycin-resistant enterococci addresses a significant healthcare challenge with US$4.6 billion in annual treatment costs.

Additionally, Immuron is diversifying revenue streams through the ProIBS® product launch in Australia, targeting the A$221 million digestive remedies market. The anticipated 1Q2026 launch aligns with their strategy of leveraging complementary products within their therapeutic focus.

The company's methodical approach to advancing multiple clinical-stage assets while growing commercial revenues demonstrates a balanced business model. However, investors should note the typical risks associated with clinical development timelines and regulatory approvals as highlighted in their forward-looking statements. The company appears positioned for potential value inflection points with multiple catalysts anticipated in late 2025.

Highlights:

• Immuron on track to exceed A$7 million in Sales this financial year
• Uniformed Services University anticipates topline results of Travelan^® clinical study in October 2025
• Immuron anticipates IMM-529 (Clostridiodes difficile infection) IND submission to the FDA in August 2025
• Launch plans underway for ProIBS^® in Australia
• Immuron anticipates IMM-986 (Vancomycin-resistant enterococci) pre-clinical research results in August 2025
  

MELBOURNE, Australia, May 30, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to provide shareholders with a brief update on progress with a number of projects.

Sales

As announced on April 10, Immuron achieved record sales up to the end of March for the current Financial Year. These were the highest in the company’s history. The momentum continued into April during the Easter and ANZAC holiday periods, as well as the spring and summer break in North America.

Immuron is on track to exceed A$7 million in sales this financial year, which is a momentous increase on the previous year’s sales of A$4.9 million.

Clinical Trial Update

Immuron has three therapeutic products under development: IMM-124E (Travelan^®) for traveller’s diarrhea; IMM-529 for Clostridioides difficile infection and IMM-986 for Vancomycin-resistant enterococci.

IMM-124E

Immuron reported on March 7 that recruitment for the Uniformed Services University Travelan^® field study had been completed. We are pleased to advise that all of the US armed services participants in this study have now been randomized and deployed. We anticipate the final visit of the Last Patient will be in July 2025 with topline results to follow in October 2025. It is hoped that this trial will enable Travelan^® to be recommended in traveller’s diarrhea guidelines thereby increasing its market potential as well as enhancing the long standing relationship with the US Department of Defense.

Following these results Immuron will request the end of Phase 2 meeting with the FDA for IMM-124E which all act as a precursor to commencement of a Phase 3 clinical program.

Based on Lumanity’s opportunity assessment prepared for Immuron, the base case yearly revenue in USA for IMM-124E is projected at US$102 million.

IMM-529

Immuron is progressing with a new Investigational New Drug (IND) application to the Food and Drug Administration (FDA) to initiate the clinical development of IMM-529 for the treatment of Clostridioides difficile infection (CDI) and prevention of recurrence of CDI. Immuron has completed a final draft of the Investigational brochure and clinical protocol, which will assist in authoring the non-clinical and clinical sections of the IND which are also largely completed. Immuron anticipates IND submission to the FDA in August 2025. Approval of this IND submission by the FDA is a precursor to commencement of a Phase 2 clinical program.

At last year’s AGM presentation, we advised Lumanity’s assessment that the IMM-529 market in the US can reach peak revenues of ~US$400 million.

ProIBS product launch

Immuron reported on March 5 that it had entered into an agreement with Calmino to distribute ProIBS^® exclusively in Australia and New Zealand. ProIBS^® is a European certified medical product for the treatment of symptoms related to IBS such as abdominal pain, bloating and changes in bowel movement (i.e., diarrhea and/or constipation). Immuron has listed ProIBS^® in Australia as a listed complementary medicine. Immuron is purchasing the product from Calmino and anticipates making a gross margin typical for a consumer health product in Australia. Immuron has now placed a purchase order with Calmino and anticipates delivery of product in 3Q2025 with a product launch in 1Q2026. The IBS treatment market in Australia is estimated to be a part of the broader "Digestives & Intestinal Remedies" market, generating a revenue of around A$221 million in 2025, with a projected annual growth rate of 3.28%.

Pre-clinical Trial Update

On January 5 Immuron reported a research collaboration with Monash University to develop a new therapeutic candidate against Vancomycin-resistant enterococci (VRE). Immuron has named this IMM-986. VRE antimicrobial resistance (AMR) poses a significant threat to healthcare systems worldwide. AMR can lead to more severe and harder-to-treat infections in healthcare settings, such as hospitals and nursing homes. These infections often result in longer hospital stays, higher medical costs, and increased mortality rates. In the U.S., the estimated national cost to treat these infections exceeds $4.6 billion annually (CDC Antimicrobial Resistance Facts and Stats). Immuron anticipates the results of this pre-clinical research to be completed in August 2025.

Thank you for your ongoing support.

Steven Lydeamore
Chief Executive Officer

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

COMPANY CONTACT:
Steven Lydeamore
Chief Executive Officer
steve@immuron.com

FORWARD-LOOKING STATEMENTS:

This document 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.

FAQ

What are Immuron's (IMRN) projected sales for the current financial year?

Immuron is on track to exceed A$7 million in sales this financial year, up from A$4.9 million in the previous year.

When will Immuron's Travelan® clinical study results be available?

The topline results for the Travelan® clinical study are expected in October 2025, following the final patient visit in July 2025.

What is the market potential for Immuron's IMM-529 drug in the US?

According to Lumanity's assessment, IMM-529 can reach peak revenues of approximately US$400 million in the US market.

When is Immuron planning to launch ProIBS® in Australia?

Immuron plans to launch ProIBS® in Q1 2026, with product delivery expected in Q3 2025.

How many therapeutic products does Immuron currently have under development?

Immuron has three therapeutic products under development: IMM-124E for traveller's diarrhea, IMM-529 for Clostridioides difficile infection, and IMM-986 for Vancomycin-resistant enterococci.