Anavex Advances Alzheimer's Phase 3 Planning as Cash Runway Extends Into Fiscal 2028

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Anavex Life Sciences is advancing Alzheimer's Phase 3 planning with the FDA after submitting its clinical trial data to a newly opened Alzheimer's IND, while reporting $118.3 million in cash and an expected operating runway into mid to late fiscal 2028. The company ended June with $118.3 million in cash and cash equivalents, up from $102.6 million at September 2025 fiscal year-end, and management expects existing cash to fund operations into mid to late fiscal 2028. Anavex has submitted all Alzheimer's clinical trial data to its new IND and plans further FDA discussions covering its U.S. clinical development programme and proposed ANAVEX2-73-AD-005 Phase 3 trial, having received scientific advice from the EMA in June on study population, endpoint hierarchy, treatment duration, statistical framework and subgroup strategy. The company is moving ahead with an approximately 170-participant adult Phase 3 Rett syndrome study and has requested an FDA meeting about adding paediatric patients, while a Fragile X syndrome IND is expected to be submitted in September. Anavex reported third-quarter net income of $7.8 million, or $0.08 per share, compared with a $13.2 million loss, or $0.16 per share, a year earlier, though the improvement was primarily driven by reversals of stock-based compensation associated with employee terminations, including the former CEO.

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Anavex Life Sciences Corp
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Cash runway extended into fiscal 2028 and net income improved, though partly due to one-time reversals.

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