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Immuron Letter to Shareholders โ€“ Projects Update
Globenewswireยท 2025-10-02 10:00
Core Insights - Immuron Limited has reported record sales for the financial year ending June 30, 2025, and is on track to exceed first quarter sales for FY24, with results expected in mid-October 2025 [3][10]. Sales Performance - The company achieved record sales up to the end of FY25 and anticipates surpassing FY24 first quarter sales [3]. - Travelan, a dietary supplement imported into the U.S., is not expected to be affected by new tariffs on pharmaceutical products [3][10]. Clinical Trial Updates - Immuron is developing three therapeutic products: IMM-124E (Travelan), IMM-529, and IMM-986 [4]. - Topline results for the Travelan clinical study are expected in October 2025, with the final patient visit anticipated in July 2025 [5][10]. - The company plans to request an end of Phase 2 meeting with the FDA for IMM-124E following the trial results, which will lead to a Phase 3 clinical program [6]. Revenue Projections - The base case yearly revenue for IMM-124E in the U.S. is projected at approximately US$102 million [7]. - The market for IMM-529 is estimated to reach peak revenues of around US$400 million [9]. Regulatory Milestones - Immuron plans to submit an Investigational New Drug (IND) application for IMM-529 to the FDA by mid-October 2025, which is necessary for starting a Phase 2 clinical program [8][10]. - The company is also progressing with initial pre-clinical studies for IMM-986, targeting Vancomycin-resistant enterococci (VRE), with completion expected by the end of 2025 [10][15]. Product Launch Plans - The launch of ProIBS, a treatment for Irritable Bowel Syndrome (IBS), is anticipated in Q4 of 2025, with a full launch planned for Q1 of 2026 [11][12]. - The IBS treatment market in Australia is projected to generate around A$221 million in 2025, with an annual growth rate of 3.28% [12].