Vivani Medical (VANI) investor relations material

Platform and market opportunity

• NanoPortal is a miniature subdermal implant designed for smooth, near-constant drug release over 6 months, 12 months or longer; administration is intended as an in-office procedure.

• NPM-139 is an investigational semaglutide implant for chronic weight management, designed to replace weekly injections with once- or twice-yearly dosing and address adherence and tolerability barriers.

• Morgan Stanley projected the global GLP-1 market could reach $190B by 2035, including an obesity-only TAM of $150B; current U.S. eligible-patient penetration was estimated at 6%.

• Market research found 56% of surveyed current GLP-1 patients were likely or definitely interested in an implant if FDA-approved, prescriber-recommended and insurance-covered; prescriber likelihood-to-prescribe rating averaged 8.3/10.

• Nexplanon global sales were $963M in FY2024 and $921M in FY2025; 80% of commercially insured adults starting a GLP-1 for obesity were women.

NPM-139 rationale and preclinical evidence

• A cited real-world study reported more than 50% of patients regularly missed GLP-1 doses, more than 50% discontinued by year 1 and 75% discontinued by year 2.

• Across approved and late-stage GLP-1 therapies, reported nausea was 25–44%, vomiting 8–24% and diarrhea 9–30%; GI-related dropouts clustered during dose escalation.

• In rats, prototype NPM-139 showed measurable semaglutide levels through 364 days and sustained weight loss versus sham controls; implant removal was followed by an immediate decline in plasma levels.

• NanoPortal retatrutide implant PK data showed sustained drug levels in an ongoing rat study, supporting exploration of next-generation incretins.

• NPM-139 is removable and designed for reversibility if discontinuation is warranted, including pregnancy or aspiration risk during surgery.

Phase 1 clinical results

• SLIM-1 enrolled 20 participants, randomized to NPM-139 or weekly Wegovy at ~0.25 mg/week for 4 weeks; primary objectives were safety, tolerability and PK characterization.

• No NPM-139 participants had treatment-related adverse events; 5 of 10 Wegovy participants had treatment-related GI adverse events, and no measurable NPM-139 drug burst was reported.

• Treatment-emergent adverse events occurred in 6/10 participants in each arm; no NPM-139 adverse events, including GI events, were reported as treatment-related.

• At Day 29, mean weight change was -0.67 kg (-0.79%) with NPM-139 versus -0.76 kg (-0.82%) with Wegovy; a 5-person NPM-139 manufacturing subgroup lost 1.54 kg (1.78%).

• SLIM-1 results showed drug release consistent with preclinical performance and supported clinical advancement.