Alterity Therapeutics, a biotechnology company focused on neurodegenerative diseases, has released its Quarterly Cash Flow Report for the first quarter of fiscal year 2026, ending September 30, 2025. The report highlights significant advancements in the development of its lead investigational therapy, ATH434, particularly for patients with Multiple System Atrophy (MSA).
“As the year draws to a close, I take pride in our achievements throughout 2025, particularly our compelling clinical outcomes in MSA,” stated David Stamler, M.D., CEO of Alterity. He expressed optimism about the potential to deliver ATH434 to those affected by this condition.
In the recent quarter, Alterity reported favorable results from a trial targeting advanced MSA and published essential neuroimaging findings from a natural history study. An independent assessment projected a potential market opportunity of approximately USD $2.4 billion for ATH434 in MSA.
Alterity is actively collaborating with the U.S. Food and Drug Administration (FDA) to prepare for a series of discussions regarding the nonclinical and manufacturing data necessary for the initiation of the Phase 3 trial. Dr. Stamler emphasized the importance of these meetings for a productive End-of-Phase 2 meeting, essential for progressing to Phase 3 trials.
As of September 30, 2025, Alterity reported a cash balance of A$54.56 million, with operating cash outflows for the quarter totaling A$5.34 million. Payments to related parties, including directors” fees and consulting fees, totaled A$108,000.
ATH434 Clinical Trial Updates
Alterity has been generating critical data required for regulatory discussions about ATH434. The FDA granted Fast Track Designation to ATH434, allowing Alterity to engage in Type C meetings concerning nonclinical and manufacturing data necessary for Phase 3 support. Following these discussions, an End-of-Phase 2 meeting is scheduled to align with the FDA on the Phase 3 program details, expected to take place in mid-2026.
In a recent presentation at the International Congress of Parkinson”s Disease and Movement Disorders, Alterity revealed a new analysis from the ATH434-201 trial. This analysis, which adjusted for baseline changes in orthostatic blood pressure, showed a strengthened efficacy signal in the 75 mg dose group after 52 weeks, indicating a relative treatment effect of 35%. The trial also demonstrated that patients receiving ATH434 experienced stability in orthostatic symptoms, unlike those on placebo.
Positive Data from ATH434-202 Trial
In July 2025, Alterity announced positive outcomes from the ATH434-202 open-label Phase 2 clinical trial focusing on more advanced stages of MSA. The trial results indicated that the 75 mg dose showed efficacy comparable to the double-blind study, particularly in key endpoints related to MSA progression and brain volume preservation. Biomarkers indicated target engagement and a safety profile consistent with previous studies.
Additionally, Alterity published findings from the bioMUSE Natural History Study in collaboration with researchers from Vanderbilt University Medical Center. The study introduced the MSA Atrophy Index, aimed at enhancing the understanding of MSA progression and supporting the use of brain atrophy markers in diagnosing and evaluating disease-modifying therapies.
Corporate Engagement and Financial Developments
Throughout the quarter, Alterity actively participated in various investment community events, including the Bioshares Biotech Summit and the Biotech Showcase in Australia. The company also completed an independent commercial assessment of ATH434, revealing a potential global peak sales opportunity of USD $2.4 billion if the drug receives approval.
The feedback from surveyed physicians underscored the significance of targeting α-synuclein aggregation in addressing MSA”s pathology, with over 70% of neurologists expressing a high likelihood of prescribing ATH434 based on the Phase 2 trial data.
Alterity strengthened its financial position by raising A$20 million through a strategic placement led by reputable healthcare-focused investment funds to advance its research programs.
For more information about Alterity Therapeutics and its innovative approach to treating neurodegenerative diseases, visit www.alteritytherapeutics.com.
