Core Insights - Actinogen Medical Limited is progressing with its pivotal phase 2/3 trial for Xanamem, targeting Alzheimer's disease, with interim analysis expected in January 2026 and final results anticipated in late 2026 [1][2] - The company has reached a significant agreement with the FDA regarding the pathway to marketing approval for Xanamem, which includes the design of an additional pivotal clinical trial and a limited number of ancillary studies [2][3] Group 1: Regulatory Developments - The FDA meeting confirmed the regulatory starting materials for drug substance synthesis and the design of one additional pivotal clinical trial [2][6] - Actinogen plans to submit a New Drug Application (NDA) in the US and to other global regulators, following the FDA's guidance [2][3] - A similar meeting with the European Medicines Agency is scheduled for 2026, indicating a global regulatory strategy [3] Group 2: Clinical Trial Details - The ongoing XanaMIA trial involves 220 participants with mild to moderate Alzheimer's disease and is currently enrolling in Australia and the US [7] - The pivotal trial will utilize a single 10 mg dose of Xanamem compared to a placebo, as agreed upon with the FDA [4][6] - The trial design includes a small number of ancillary clinical pharmacology trials and nonclinical studies to further characterize Xanamem [6] Group 3: Product Information - Xanamem (emestedastat) is a novel oral therapy designed to control cortisol levels in the brain, which is linked to Alzheimer's disease progression and depressive symptoms [8] - The drug has shown promising safety and efficacy in previous clinical trials, with over 400 participants treated [7][8] - Xanamem's mechanism of action involves inhibiting the cortisol synthesis enzyme 11β-HSD1, targeting areas of the brain where cortisol is known to be toxic [8]

For personal use only Bioshares Annual Conference Q&A presentation Hobart August 7, 2025 ® Xanamem is a registered trademark of Actinogen Medical Limited Disclaimer For personal use only Bioshares Q&A August 7, 2025 2 • This presentation has been prepared by Actinogen Medical Limited. ("Actinogen" or the "Company") based on information available to it as at the date of this presentation. The information in this presentation is provided in summary form and does not contain all information necessary to make a ...

Phase 2b/3 Alzheimer’s trial enrolment expected to reach 100 this quarter, triggering an interim analysis 6 months laterSYDNEY, April 30, 2025 (GLOBE NEWSWIRE) -- Actinogen Medical Limited (ASX: ACW) announces that its Alzheimer’s disease phase 2b/3 trial has now enrolled 60 participants and expects to reach 100 by the end of this quarter. That milestone will trigger an interim analysis of available trial data by an independent Data Monitoring Committee approximately 6 months later. Final results for the fu ...