Highlights: Immuron on track to exceed A$7 million in Sales this financial yearUniformed Services University anticipates topline results of Travelan® clinical study in October 2025Immuron anticipates IMM-529 (Clostridiodes difficile infection) IND submission to the FDA in August 2025Launch plans underway for ProIBS® in AustraliaImmuron anticipates IMM-986 (Vancomycin-resistant enterococci) pre-clinical research results in August 2025 MELBOURNE, Australia, May 30, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (AS ...

Sales Performance - Immuron Limited has achieved record sales exceeding AUD$5 million in a fiscal year, marking the highest sales in the company's history [1][2] - For the March 2025 quarter, global sales reached AUD$1.3 million, a 2% increase compared to the prior year, while year-to-date sales amounted to AUD$5.3 million, reflecting a 46% increase [1][2] - In Australia, year-to-date sales were AUD$3.7 million, up 34% year-over-year, with the March 2025 quarter sales at AUD$0.5 million, a 28% increase [1][2] - North American sales for the year-to-date reached AUD$1.6 million, an impressive 86% increase compared to the previous year [1][2] Product Overview - Travelan® is an over-the-counter immune supplement designed to target pathogenic bacteria and their toxins in the gastrointestinal tract, reducing the likelihood of travelers' diarrhea [1][4] - The product is available in Australia as a listed medicine, in Canada as a licensed natural health product, and in the U.S. as a dietary supplement [4] Market Position - Travelan® has been ranked 1 by market share change, 2 by SKU, and 3 by brand in the Anti-diarrheal category in Australia [2] - The company has seen strong sales growth due to its travel activation program and expanded pharmacy agreements, particularly in the lead-up to peak travel seasons [2]

Company Overview - Immuron Limited is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of inflammatory mediated and infectious diseases [6] - The company has entered into an exclusive distribution agreement for ProIBS® in Australia and New Zealand, expanding its product portfolio [1][4] Product Information - ProIBS® is a certified medical device designed to treat symptoms of irritable bowel syndrome (IBS), including abdominal pain, bloating, and bowel movement issues [3] - The product contains AVH200®, derived from Aloe barbadensis Miller, which supports the intestinal mucosal barrier and is suitable for long-term use [3] - A usability study indicated that 94% of users found ProIBS® helpful, with 91% reporting an improvement in daily life and 98% willing to recommend it [3] Market Context - IBS affects approximately 30% of the population, with females being more likely to be affected [2] - The IBS treatment market in Australia is part of the broader "Digestives & Intestinal Remedies" market, projected to generate around AU$221.14 million in 2025, with an annual growth rate of 3.28% [2] Strategic Insights - The Chief Commercial Officer of Immuron highlighted the opportunity to expand the digestive health portfolio with ProIBS®, leveraging the success of the Travelan® brand [4] - The CEO of Calmino group AB expressed confidence in the collaboration with Immuron, recognizing Australia and New Zealand as significant markets with growth potential [5]

Core Insights - Immuron Limited has entered a research collaboration with Monash University to develop new therapeutic drug candidates targeting antimicrobial resistant pathogens [1][2] - The collaboration will utilize Immuron's technology platform and the expertise of the Biomedicine Discovery Institute led by Professor Dena Lyras [2] - The initial activities of the collaboration will not require additional funding beyond Immuron's existing research budget [3] Project Proposals - The first project will investigate the mechanisms by which bacteria share and transfer DNA, contributing to antimicrobial resistance, with the goal of developing broad-spectrum therapeutic products [5] - The second project will focus on Vancomycin-resistant enterococci (VRE), which are significant nosocomial pathogens that complicate treatment outcomes for vulnerable patients [7] Market Context - Antimicrobial resistance (AMR) is a major global health threat, leading to severe infections and increased healthcare costs, with the U.S. alone spending over $4.6 billion annually to treat such infections [6] - The global antibiotics market is projected to reach $57.0 billion by 2026, growing at a compound annual growth rate (CAGR) of 4.0%, driven by the rising prevalence of drug-resistant infections [8]

Core Insights - Immuron Limited has submitted the Clinical Study Report for its Phase 2 study of Travelan (IMM-124E) to the FDA and plans to request an end of Phase 2 meeting, which is necessary to advance to Phase 3 [1] Group 1: Clinical Study Results - The Phase 2 clinical study demonstrated statistically significant lower levels of IgA and IgG in subjects receiving Travelan compared to the placebo group, indicating reduced exposure to ETEC antigens [2] - There was a statistically significant reduction in the number of colony-forming units (CFUs) in the stools of subjects who received Travelan, measured 48 hours post-challenge (p = 0.0121), suggesting faster clearance of ETEC from the gastrointestinal tract [3] - Participants in the Travelan group exhibited a more stable gastrointestinal microbiota compared to the placebo group, with improved alpha diversity metrics indicating greater richness and evenness of bacterial species [4] Group 2: Microbiome Analysis - Statistically significant differences in beta diversity were observed between the treatment groups, with the Travelan group showing increased levels of beneficial bacteria such as Akkermansia and Faecalibacterium [5] - The data indicated a potential link between the presence of certain bacterial species and reduced inflammation, suggesting that Travelan may aid in the recovery of the gut microbiome [6] Group 3: Ongoing Studies - A field study conducted by the Uniformed Services University has randomized a total of 776 subjects to evaluate a dietary supplement for maintaining gut health during deployment and travel, with follow-up expected to be completed around June 2025 [7]

Company Overview - Immuron Limited is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases [4] - The company is listed on both the ASX (ASX: IMC) and NASDAQ (NASDAQ: IMRN) [4] Recent Company Highlights - Global sales increased by 172% in FY24, reaching $4.90 million, with record Travelan® sales of $4.86 million [4] - The company achieved record monthly sales of A$1.49 million in October 2024 (unaudited) [4] - Immuron is planning a Phase 2 trial for IMM-529 after receiving positive FDA pre-IND feedback [4] Product Information - Travelan® is an orally administered passive immunotherapy that reduces the likelihood of contracting travelers' diarrhea, caused by pathogenic bacteria [5] - Travelan® is a highly purified tabletized preparation of hyperimmune bovine antibodies, effective in binding to diarrhea-causing bacteria [5] - In Australia, Travelan® is listed as a medicine for reducing the risk of travelers' diarrhea and minor gastrointestinal disorders [5] Clinical Development - IMM-124E, the active ingredient in Travelan®, is developed from the colostrum of immunized cattle and targets enterotoxigenic E. coli (ETEC) [9][10] - IMM-529 is being developed as an adjunctive therapy for recurrent Clostridioides difficile infection (CDI), targeting multiple virulence components [13][14] - Pre-clinical results for IMM-529 show promising outcomes in preventing primary disease (80% efficacy), protecting against disease recurrence (67% efficacy), and treating primary disease (78.6% efficacy) [15]

Company Overview - Immuron Limited is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases [4] - The company is listed on both the Australian Securities Exchange (ASX: IMC) and NASDAQ (NASDAQ: IMRN) [4] Recent Developments - The Chief Executive Officer, Steven Lydeamore, presented at the 21st Virtual Investor Summit Microcap Event on November 21, 2024 [1] - A copy of the presentation is available on the company's website [2] Product Information - Travelan® is an orally administered passive immunotherapy that reduces the likelihood of contracting travelers' diarrhea, which is caused by pathogenic bacteria [5] - Travelan® is a highly purified tabletized preparation of hyperimmune bovine antibodies and is indicated for reducing the risk of travelers' diarrhea and minor gastrointestinal disorders in Australia and Canada [5] - In the U.S., Travelan® is marketed as a dietary supplement for digestive tract protection [5] Technology Platform - Immuron's proprietary technology is based on polyclonal immunoglobulins (IgG) derived from engineered hyper-immune bovine colostrum, allowing for the production of highly specific immunoglobulins to any enteric pathogen [7] - The platform technology enables the development of medicines across a wide range of infectious diseases by blocking viruses or bacteria at mucosal surfaces [7] Research and Development - IMM-124E, developed using Immuron's platform technology, is produced from the colostrum of immunized cattle and targets enterotoxigenic E. coli (ETEC) [8][9] - IMM-529 is being developed as an adjunctive therapy for the prevention and treatment of recurrent Clostridioides difficile infection (CDI) [12] - The unique three-target approach of IMM-529 has shown promising results in pre-clinical models, including prevention of primary disease (80% efficacy), protection against disease recurrence (67% efficacy), and treatment of primary disease (78.6% efficacy) [14]

Company Overview - Immuron Limited is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases [2] - The company is listed on both the Australian Securities Exchange (ASX: IMC) and NASDAQ (NASDAQ: IMRN) [2] Product Information - Travelan® is an orally administered passive immunotherapy that reduces the likelihood of contracting travelers' diarrhea, which is caused by pathogenic bacteria [3] - Travelan® is a highly purified tabletized preparation of hyper immune bovine antibodies that binds to diarrhea-causing bacteria, preventing colonization [3] - In Australia, Travelan® is a listed medicine indicated for reducing the risk of travelers' diarrhea and minor gastrointestinal disorders [3] - In Canada, it is a licensed natural health product, while in the U.S., it is sold as a dietary supplement for digestive tract protection [3] Technology and Development - Immuron's proprietary technology is based on polyclonal immunoglobulins (IgG) derived from engineered hyper-immune bovine colostrum, allowing for the production of highly specific immunoglobulins to any enteric pathogen [5] - The platform technology enables the development of medicines across a wide range of infectious diseases, effectively blocking viruses or bacteria at mucosal surfaces [5] Clinical Development - IMM-124E, developed using Immuron's platform technology, targets enterotoxigenic Escherichia coli (ETEC) and is produced from the colostrum of immunized cattle [6][8] - IMM-529 is being developed as an adjunctive therapy for the prevention and treatment of recurrent Clostridioides difficile infection (CDI), targeting key virulence components [9][10] - Pre-clinical results for IMM-529 show promising outcomes in preventing primary disease (80% efficacy), protecting against disease recurrence (67% efficacy), and treating primary disease (78.6% efficacy) [11]

Sales Performance - Immuron Limited reported strong sales growth for Travelan®, with total sales of AUD $1.5 million in the September 2024 Quarter, representing a 13% increase compared to the prior quarter [1] - Sales in Australia increased by 3% to AUD $1.007 million in the September 2024 Quarter, up from AUD $0.983 million in the June 2024 Quarter [2] - North American sales saw a significant increase of 48%, reaching AUD $0.456 million in the September 2024 Quarter compared to AUD $0.309 million in the June 2024 Quarter [3] Market Expansion - The company has secured core ranging in nine additional pharmacy banner groups in Australia, enhancing its market presence [2] - Immuron achieved its strongest monthly sales on amazon.com in the US, indicating robust demand in the North American market [2] - Distribution has expanded to ten pharmacy and grocery retailers in Canada, further solidifying the company's footprint in North America [2] Product Overview - Travelan® is an orally administered passive immunotherapy designed to reduce the likelihood of travelers' diarrhea, which is commonly caused by pathogenic bacteria [3] - The product is a purified tablet preparation of hyper-immune bovine antibodies, which bind to diarrhea-causing bacteria and prevent their colonization [3] - Travelan® is registered as a medicine in Australia and as a licensed natural health product in Canada, while in the U.S., it is marketed as a dietary supplement [3]

Core Viewpoint - Immuron Limited has announced the completion of an interim analysis for a clinical evaluation of a new oral therapeutic targeting Campylobacter and Enterotoxigenic Escherichia coli (ETEC) in collaboration with the US Naval Medical Research Command (NMRC) [1][2] Company Overview - Immuron Limited is an Australian biopharmaceutical company focused on developing and commercializing orally delivered targeted polyclonal antibodies for the treatment of infectious diseases [14] - The company has developed two commercially available oral immunotherapeutic products for gut-mediated diseases [1] Clinical Trial Details - The NMRC funded the clinical trial, which involved a hyperimmune bovine colostrum product developed by Immuron using a conjugated vaccine targeting Campylobacter and ETEC [3][4] - The trial enrolled 27 volunteers in a randomized, placebo-controlled study, demonstrating a 10.4% protective efficacy against moderate to severe campylobacteriosis compared to the placebo group [5] Future Plans - Immuron plans to hold an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to initiate Phase 3 clinical trials of Travelan® in the second half of 2025 [2] - The company anticipates topline results from a clinical study of Travelan® involving 866 participants, with 85% recruitment completed and results expected in April 2025 [2] Product Information - Travelan® is an orally administered passive immunotherapy that reduces the likelihood of contracting traveler's diarrhea, caused by pathogenic bacteria [12] - The product is available in Australia as a listed medicine and in Canada as a licensed natural health product, while in the U.S., it is sold as a dietary supplement for digestive tract protection [12] Industry Context - Infectious diarrhea is a common illness among travelers and military personnel, with a high priority for preventative treatments due to increasing antibiotic resistance among enteric pathogens [10] - The NMRC is developing new vaccines targeting Campylobacter and ETEC, as well as other pathogens, in collaboration with Immuron [8]