Annovis Bio (ANVS) investor relations material

Drug candidate and mechanism of action

• Buntanetap is a once-daily oral pill in late-stage development, targeting RNA to inhibit overproduction of multiple neurotoxic proteins linked to neurodegeneration, improving cell communication and reducing inflammation.

• Demonstrates unique efficacy by improving cognition in Alzheimer's and both cognition and motor function in Parkinson's patients.

• Mechanism involves specific inhibition of neurotoxic protein translation via RNA targeting, with proven reduction in APP, Aβ42, tau, and a-synuclein in preclinical and clinical studies.

• Buntanetap also improves axonal transport, decreases inflammation, and protects nerve cells from death in animal models.

Clinical development and pipeline

• Over 1,600 people have been treated with buntanetap across multiple completed and ongoing clinical studies in Alzheimer's and Parkinson's disease.

• Pivotal Phase 3 trials in early Alzheimer's (n=850, ongoing) and Parkinson's (n=450, completed) are key milestones, with open-label extensions planned or ongoing.

• Pipeline includes additional indications such as Parkinson's disease dementia, traumatic brain injury, stroke, and combination therapies with Trulicity and Viagra.

• NDA submission for Alzheimer's is targeted for Q1 2027 (symptomatic) and Q1 2028 (disease-modifying), with significant US market opportunities.

Efficacy and biomarker data

• Buntanetap shows significant cognitive improvement in mild and moderate Alzheimer's and Parkinson's patients, especially those with biomarker-confirmed amyloid and tau pathology.

• Biomarker analyses confirm reductions in plasma pTau217, total tau, and brain-derived tau, supporting target engagement and pathway modulation.

• Dose-dependent lowering of APP and Aβ40 production rates demonstrated in clinical studies using SILK analysis.