Vivani Medical (VANI) Emerging Growth Conference 2025 summary

Market opportunity and unmet needs

• Chronic disease medication non-adherence affects over 50% of patients, leading to suboptimal outcomes and rapid weight rebound after discontinuation.

• GLP-1-based drugs have transformed obesity and diabetes treatment, but adherence and tolerability remain major challenges.

• Current solutions focus on injectables and orals, but no approved oral GLP-1s exist; most options require frequent administration.

• The implant approach offers long-lasting treatment with the option for removal, addressing both adherence and safety.

• Peptide-based GLP-1s are most effective, but current delivery methods are costly and inconvenient.

Technology and clinical progress

• The NanoPortal platform enables subdermal implants for steady drug delivery, aiming for once or twice yearly administration.

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

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

• No evidence of dose dumping or serious adverse events was observed in human studies.

• The technology uses titanium oxide nanotubes to control drug release, achieving constant delivery over months.

Development plans and pipeline

• Semaglutide implant (NPM-139) prioritized for clinical development, with phase I and II studies planned to start in the first half of next year.

• Phase I will be a 28-day low-dose study; phase II will compare multiple implant doses to placebo and standard injections over 4-6 months.

• Additional pipeline includes semaglutide for type 2 diabetes (NPM-133), chronic kidney disease, MASH, Alzheimer's, and alcohol addiction.

• Animal health applications are being explored in partnership with an animal health company.

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