Alterity Therapeutics (ATH) Q1 2027 TU earnings summary

Executive summary

• FDA End-of-Phase 2 minutes aligned on ATH434’s Phase 3 design and registrational pathway in MSA; Phase 3 start-up activities are underway.

• New U.S. composition-of-matter patent extends ATH434 protection to 2045 and supports potential development in Parkinson’s disease.

Financial highlights

• Cash and cash equivalents were A$41.308 million at 30 September 2026, versus A$37.318 million at quarter start; quarterly operating cash outflow was A$1.339 million.

• Operating cash flow included A$3.940 million in government grants and tax incentives; the reported FY2025 R&D refund totaled A$3,982,992, including interest.

• Quarterly equity issuance proceeds were A$5.803 million, with A$0.305 million of transaction costs; net financing cash flow was A$5.469 million.

Outlook and guidance

• Planned Phase 3 trial: approximately 200 patients randomized 1:1 to ATH434 50 mg or placebo twice daily for 12 months.

• FDA agreed that one pivotal trial plus confirmatory evidence could support an NDA; Phase 2 ATH434-201 data are anticipated to provide the confirmatory evidence.

• Phase 3 operational work includes protocol finalization, vendor selection, site qualification and manufacture of the first registration batch.