Alterity Therapeutics (ATHE) issued a letter to shareholders, which read in part, “Our goal for 2025 was the successful completion of the Phase 2 program investigating our lead asset, ATH434, in multiple system atrophy and to produce data that would enable us to advance into Phase 3. We accomplished this mission and then some. Results from the Phase 2 trials were resoundingly favourable with data demonstrating the drug to be safe and well-tolerated with strong signals of efficacy in an indication that, at present, has no approved disease-modifying treatments available for patients. As a result, optimism at Alterity is abound, and we are now focused on advancing ATH434 towards a pivotal Phase 3 clinical program in MSA and potential entry into an estimated $2.4B market opportunity. As 2026 begins, Alterity is positioned to achieve several clinical and operational milestones that offer the potential to greatly enhance the company’s value, while elevating its position among the top echelon of innovators in addressing neurodegeneration. I am pleased to share with you more details on what has been accomplished and what we soon plan to achieve…Alterity enters 2026 with one of the most promising clinical programs in MSA worldwide, a growing body of supportive scientific evidence, and a strengthened platform to deliver meaningful value to patients and shareholders. A key milestone during the year will be our End-of-Phase 2 meeting with the FDA in mid-2026, which represents the final regulatory step before initiating our pivotal, Phase 3 study. In parallel, we anticipate an active year of publications, conference presentations, and expanded external activities. In summary, we have three key objectives in 2026: Finalize our regulatory strategy in order to initiate our Phase 3 trial for ATH434 in MSA; Deepen our external engagement across the medical, advocacy, investor, and partner communities; and, Build for scalable growth including a focus on expanding our intellectual property protection. This is a very exciting time in the growth and evolution of Alterity as evidenced by a very productive series of meetings in San Francisco around the annual J.P. Morgan Healthcare conference last week. I would like to thank our employees for their dedication, and our shareholders for their ongoing support as we embark on what we believe will be a dynamic and value-building 2026. We remain committed to our mission of improving the lives of people living with debilitating and devastating neurodegenerative diseases.”
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