Workflow
Appendix 4C – Q4 FY25 Quarterly Cash Flow Report
Globenewswire·2025-07-30 11:25

Core Viewpoint - Alterity Therapeutics has made significant progress in the development of ATH434 for the treatment of Multiple System Atrophy (MSA), highlighted by the U.S. FDA granting Fast Track designation, which underscores the potential of this therapy to address unmet medical needs in MSA patients [2][4]. Financial Summary - As of June 30, 2025, Alterity's cash position was A$40.66 million, with operating cash outflows for the quarter amounting to A$2.35 million [3]. - The company raised A$26.3 million in gross proceeds from a two-tranche placement and received a refund of A$3.98 million from the Australian Taxation Office under the Research and Development Tax Incentive Scheme [16]. Clinical Developments - The Fast Track designation for ATH434 was granted in May 2025, aimed at accelerating its development and review process due to its potential as an innovative treatment for MSA, a disease currently without approved therapies [4][5]. - Positive results from the ATH434-201 Phase 2 clinical trial were presented, showing a 48% relative treatment effect at the 50 mg dose and a 30% effect at the 75 mg dose on the modified UMSARS I scale [7][8]. - The ATH434-202 open-label Phase 2 trial also reported positive topline data, indicating clinical benefits and stabilization of key biomarkers in a more advanced MSA patient population [10][11]. Efficacy and Safety - ATH434 demonstrated a favorable safety profile, with no serious adverse events reported and similar adverse event rates compared to placebo [14]. - Neuroimaging data indicated that ATH434 stabilized or reduced iron accumulation in MSA-affected brain regions and showed trends in reducing brain atrophy [9][12]. Research and Innovation - The MSA Atrophy Index (MSA-AI), developed in the bioMUSE Natural History Study, was featured in a peer-reviewed journal, providing a novel measure for tracking disease progression in MSA patients [15]. - The use of deep learning methods in defining neuroanatomy and developing the MSA-AI can enhance understanding of MSA progression and support the evaluation of disease-modifying therapies [15].