Vivani Medical (VANI) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Strategic focus and technology overview

• Developing ultra-long-acting subdermal implants to address medication non-adherence in chronic diseases, starting with GLP-1 treatments for obesity and diabetes.

• Implants use NanoPortal technology, enabling precise, constant drug release via titanium oxide nanotubes.

• Platform technology is adaptable to multiple drug classes and chronic conditions, with initial focus on GLP-1 agonists.

• Differentiation from prior attempts (e.g., Intarcia) through demonstrated non-fluctuating release rates, leading to FDA IND clearance.

• Partnership in animal health for similar implant technology is in the pipeline.

Product pipeline and clinical plans

• Lead program NPM-115: six-month exenatide implant for chronic weight management in obese or overweight patients.

• Additional programs include NPM-139 (different GLP-1 molecule) and a type 2 diabetes indication.

• Animal studies show six months of therapeutic pharmacokinetics and comparable efficacy to semaglutide in weight loss and liver fat reduction.

• First in-human trial (LIBERATE-1) to begin in Q4, enrolling overweight/obese patients, with results expected mid-2025.

• 505(b)(2) regulatory pathway planned, with PK comparison to marketed products.

Market opportunity and adoption potential

• GLP-1 market is rapidly growing, with significant unmet need due to poor adherence to current therapies.

• Survey data: 56% of current GLP-1 patients would likely use a six-month implant if approved and covered.

• Prescriber research: high likelihood (8.3/10) of recommending the implant, especially in primary care.

• Payers have strong incentives to support improved adherence solutions.

• Real-world adherence to current GLP-1 therapies remains low, with only 40% of patients on therapy after one year.