Core Viewpoint - Alterity Therapeutics is advancing its ATH434 program for Multiple System Atrophy (MSA), with strengthened Phase 2 data and a solid cash position, while preparing for a pivotal Phase 3 clinical trial and engaging with the FDA [2][3][7]. Phase 2 Clinical Program & Regulatory Progress - The company has made significant progress in its Phase 2 trial for ATH434, with new analyses enhancing confidence in its potential as a disease-modifying therapy for MSA, projecting a commercial opportunity of US$2.4 billion [3][4]. - Preparations for an End-of-Phase 2 meeting with the FDA are underway, aimed at aligning on the design and requirements for a pivotal Phase 3 trial [5][9]. - A new analysis from the Phase 2 trial showed an improved efficacy signal in the 75 mg dose group, with a relative treatment effect increase from 30% to 35% compared to placebo [6]. Cash Position - As of December 31, 2025, the company reported a cash balance of A$49.2 million, with operating cash outflows of A$5.28 million for the quarter, providing a solid runway for regulatory and clinical objectives [21]. Corporate and Financial Update - The governance and leadership structure has been strengthened to support the transition into late-stage development, with key appointments made to enhance strategic execution [15][20]. - The company is exploring non-dilutive funding pathways for Phase 3 development through ongoing discussions with pharmaceutical partners [7][14]. Scientific and Clinical Engagement - Alterity has actively engaged with the global neurology community through scientific presentations, which are crucial for disseminating clinical data and refining interpretations of Phase 2 results [11][12]. - A Clinical Advisory Board meeting was held to review Phase 2 data and provide expert input for the Phase 3 trial design [12]. Outlook - The company is focused on advancing ATH434 toward a pivotal Phase 3 program, ensuring regulatory alignment with the FDA, and pursuing strategic partnerships to maximize long-term shareholder value [23].
Alterity Therapeutics: Appendix 4C – Q2 FY26 Quarterly Cash Flow Report & Corporate Update