Vivani Medical (VANI) investor relations material

Market opportunity and unmet needs

• Chronic disease medication non-adherence affects over 50% of patients, leading to suboptimal outcomes.

• GLP-1 drugs have transformed obesity and diabetes treatment, but adherence and persistence remain low.

• Discontinuation of GLP-1 therapy often results in rapid weight regain and worsened health.

• Current treatments require frequent administration, limiting access and convenience for many populations.

• Market for GLP-1 products is growing rapidly, with over $14B in sales and a 32% CAGR expected.

Technology and clinical progress

• NanoPortal platform enables subdermal implants for steady, long-term drug delivery, improving adherence.

• Lead program is a semaglutide implant for obesity, with preclinical data showing ~20% weight loss over 7 months.

• First-in-human study with exenatide implant showed positive safety, tolerability, and pharmacokinetics.

• Implants are designed for once or twice yearly dosing, with customizable size and dose for patient needs.

• Technology allows for controlled, constant drug release, minimizing fluctuations and improving tolerability.

Development plans and pipeline

• Semaglutide implant clinical program to begin in the first half of next year, with phase 1 and 2 studies planned.

• Pipeline includes additional indications: type 2 diabetes, chronic kidney disease, NASH, Alzheimer's, and animal health.

• Exenatide implant remains in the pipeline, with next steps under evaluation.

• Market research indicates strong patient and prescriber interest in long-acting GLP-1 implants.

• Facility in Alameda, CA supports GMP manufacturing for clinical and early commercial supply.