Annovis Bio (ANVS) investor relations material

Clinical development and pipeline

• Lead asset buntanetap targets both Alzheimer's and Parkinson's diseases, with pivotal Phase 3 trials ongoing or completed in both indications.

• Over 1,200 individuals have been treated with buntanetap across multiple clinical studies, including safety, efficacy, and biomarker analyses.

• The pipeline includes additional indications such as Parkinson's disease dementia, traumatic brain injury, stroke, and combination therapies.

• NDA submission for Alzheimer's is targeted for Q4 2026, with Parkinson's milestones following.

Efficacy and safety results

• Buntanetap improved cognition in biomarker-positive mild Alzheimer's and Parkinson's patients, with the most pronounced effects in those with MMSE > 20.

• Phase 3 Parkinson's study met endpoints in the per-protocol population, showing significant improvements in motor and cognitive scores.

• Safety profile is strong across APOE4 carriers and non-carriers in Alzheimer's and in the Parkinson's ITT population, with low rates of serious adverse events.

• Biomarker data show reductions in neurotoxic proteins, inflammation, and neuronal damage markers in treated patients.

Mechanism of action and target engagement

• Buntanetap is a small molecule that targets RNA to inhibit the translation of multiple neurotoxic proteins implicated in neurodegeneration.

• Demonstrated dose-dependent reduction in APP, Aβ40, and Aβ42 synthesis in clinical studies, confirming target engagement.

• Improves axonal transport and reduces inflammation and neuronal cell death in preclinical models.

• Specific binding to APP IRE but not ferritin IRE supports selectivity for neurotoxic protein mRNAs.