Annovis Provides Corporate Updates and Reports Fiscal Year 2025 Financial Results

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Annovis Bio, a Phase 3 clinical-stage biotechnology company, announced business updates and reported financial results for the fiscal year 2025. The company achieved significant milestones, including the initiation of a pivotal Phase 3 clinical trial for its investigational oral therapy buntanetap in early Alzheimer's disease and the launch of an open-label extension study in Parkinson's disease. Annovis also reported encouraging data from its previous Alzheimer's and Parkinson's programs, demonstrating buntanetap's potential disease-modifying effects.

Why it matters

Annovis' progress with buntanetap represents an important step forward in the development of treatments for Alzheimer's and Parkinson's diseases, two of the most prevalent and devastating neurodegenerative disorders. The initiation of pivotal trials and positive biomarker data suggest the drug candidate may have the potential to halt disease progression and improve cognitive and motor functions in patients.

The details

In 2025, Annovis launched a pivotal Phase 3 study evaluating buntanetap as both a symptomatic and potential disease-modifying treatment in early Alzheimer's disease patients. The company also reported new biomarker data from its previous Alzheimer's and Parkinson's trials, demonstrating buntanetap's ability to reduce levels of neurotoxic proteins, neuroinflammation, and neurodegeneration. Additionally, Annovis initiated an open-label extension study in Parkinson's disease to further evaluate the long-term safety and efficacy of buntanetap.

• In February 2025, Annovis launched a pivotal Phase 3 study in early Alzheimer's disease.
• In October 2025, Annovis announced the first participants reached the 6-month milestone in the Alzheimer's disease trial.
• In November 2025, Annovis reported novel biomarker data linking amyloid co-pathology in Parkinson's disease to accelerated cognitive decline.
• In December 2025, Annovis announced the initiation of an open-label extension study in Parkinson's disease.
• In January 2026, Annovis met with the FDA to discuss a new study in Parkinson's disease dementia.

What they’re saying

What’s next

Annovis plans to continue the pivotal Phase 3 Alzheimer's disease trial and the open-label extension Parkinson's disease study, as well as discuss a new study in Parkinson's disease dementia with the FDA.