Core Insights - Immuron Limited is advancing its clinical trials for Travelan and IMM-529, with significant updates on both products [1][2][3] IMM-529 IND (Clostridioides difficile infection) - On October 8, 2025, Immuron submitted an Investigational New Drug (IND) application to the FDA for IMM-529 aimed at preventing or treating Clostridioides difficile infection [2] - The FDA has acknowledged the IND application and is currently reviewing it, having requested additional clinical information [3] - Immuron has responded to the FDA's queries and made minor updates to the clinical trial protocol ahead of the 30-day decision date [3] Travelan Clinical Trials - The Uniformed Services University was expected to provide topline results from the Travelan P2TD study by the end of October 2025, but results are now delayed until the end of November 2025 due to a government shutdown [4][8] - The outcomes of the P2TD clinical study will influence Immuron's dosing strategy for its End-of-Phase 2 meeting with the FDA, with a potential proposal for a twice-daily dosing regimen if results are favorable [5] - Immuron has conducted multiple Travelan clinical trials, with varying dosing regimens and significant results in protecting against diarrhea [6][7] Travelan Product Information - Travelan is an orally administered passive immunotherapy designed to reduce the likelihood of travelers' diarrhea caused by pathogenic bacteria [12] - It is available in Australia as a listed medicine and in Canada as a licensed natural health product, while in the U.S., it is marketed as a dietary supplement [12] IMM-529 Development - IMM-529 is being developed as an adjunctive therapy with standard antibiotics for recurrent Clostridioides difficile infection, targeting multiple virulence components of the bacteria [19][20] - Pre-clinical studies have shown promising results, including an 80% prevention rate for primary disease and a 67% protection rate against disease recurrence [21]

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]