Alterity Therapeutics reported a widening half-year loss as it pushes its lead drug ATH434 closer to late-stage trials for Multiple System Atrophy, supported by a fresh $20 million capital raise.
- Net loss increased to A$9.62 million for H1 FY2026
- Positive Phase 2 results reinforce ATH434’s potential in MSA
- Preparations underway for mid-2026 FDA End-of-Phase-2 meeting
- Raised approximately A$20 million to fund Phase 3 development
- Leadership strengthened with new Chair and Managing Director appointments
Financial Overview
Alterity Therapeutics Limited has reported a net loss after tax of A$9.62 million for the half-year ended 31 December 2025, marking a 34% increase from the previous corresponding period. Despite the widening loss, the company’s cash reserves have grown to a robust A$49.2 million, bolstered by a recent capital raise of approximately A$20 million. This financial position provides a solid runway to support ongoing clinical and regulatory activities.
Clinical Progress on ATH434
The company’s lead asset, ATH434, an oral iron chaperone targeting Multiple System Atrophy (MSA), continues to advance with encouraging Phase 2 clinical data. Additional analyses from the ATH434-201 and ATH434-202 studies demonstrated clinically meaningful slowing of disease progression and a favourable safety profile across different stages of MSA. Notably, ATH434 showed benefits in managing orthostatic hypotension, a debilitating symptom of MSA, which could enhance patients’ quality of life.
Regulatory and Strategic Developments
Alterity is preparing for a pivotal End-of-Phase-2 meeting with the U.S. Food and Drug Administration scheduled for mid-2026. This engagement will be critical in shaping the design of the planned Phase 3 trial, including patient selection and clinical endpoints. The company has also expanded its scientific outreach through multiple international conferences, reinforcing its biomarker-driven approach and engaging with key opinion leaders in neurodegenerative disorders.
Commercial Potential and Partnerships
An independent commercial assessment suggests a potential global peak sales opportunity of approximately US$2.4 billion for ATH434 in MSA, underpinned by strong physician interest. Reflecting this, Alterity has broadened strategic discussions with pharmaceutical partners and advisers to explore collaboration and non-dilutive funding options for the Phase 3 program.
Leadership and Governance Enhancements
In November 2025, Alterity strengthened its leadership team with the appointment of Mr Julian Babarczy as Chairman and Dr David Stamler as Managing Director, complementing his CEO role. These changes, alongside new senior management hires focused on investor relations and corporate strategy, position the company to effectively navigate the regulatory landscape and investor engagement as it advances toward late-stage clinical development.
Bottom Line?
Alterity’s strategic investments and clinical momentum set the stage for a critical regulatory milestone in 2026, with market watchers keenly awaiting Phase 3 trial initiation.
Questions in the middle?
- Will the FDA’s End-of-Phase-2 feedback accelerate or alter the planned Phase 3 trial design?
- How will Alterity’s partnerships influence funding and commercialisation timelines?
- What are the prospects for ATH434’s application beyond MSA, such as Parkinson’s disease?