Vivani Medical (VANI) investor relations material

Market landscape and unmet needs

• GLP-1 drugs have transformed obesity and type 2 diabetes treatment, but adherence remains a major challenge, with fewer than 50% of patients taking medication as prescribed and high discontinuation rates within a year.

• Poor medication adherence and dose fluctuations in current therapies lead to suboptimal outcomes, rapid weight rebound, and exacerbated tolerability issues.

• Certain patient populations, such as those with severe autism or dementia, are underserved by current GLP-1 delivery methods.

• Market research indicates strong patient and prescriber interest in a 6-month GLP-1 implant, with 56% of patients likely to adopt if approved and covered.

• GLP-1 market projected to reach $190B by 2035, with obesity-only TAM at $150B and current U.S. penetration at 6%.

Technology and product development

• NanoPortal technology enables ultra long-acting, miniature drug implants with tunable, near-constant release profiles for infrequent dosing (6-12 months or longer).

• Lead program NPM-139 is a semaglutide implant for chronic weight management, designed for twice-yearly administration, with clinical program initiation planned for mid-2026.

• Preclinical studies show over 20% weight loss maintained for a year after a single implant, with steady pharmacokinetics, significant liver fat reduction, and no dose dumping.

• The technology has been successfully applied to exenatide, semaglutide, and retatrutide, demonstrating versatility.

• Pipeline includes next-generation incretin implants and products for type 2 diabetes and veterinary obesity, with some partnered programs.

Clinical progress and future plans

• Initial clinical study with exenatide implant demonstrated safety, tolerability, and consistent drug release, supporting pivot to semaglutide.

• LIBERATE-1 first-in-human study met primary objectives, showing positive safety, tolerability, and device performance, with no serious adverse events.

• The SLIM-1 clinical trial for the semaglutide implant is set to begin mid-year, focusing on safety, pharmacokinetics, and weight outcomes in humans.

• NPM-139 clinical program includes Phase 1 (safety, PK) and Phase 2 (dose-ranging, weight maintenance) studies, with initiation projected for mid-2026.

• Data from the first human study is expected in Q4, with plans to proceed to a phase II dose-finding study for maintenance phase positioning.