Announcement • Aug 06
Vivani Medical Announces Successful Dosing Of All Participants In SLIM-1 Phase 1 Trial Evaluating NPM-139 Miniature Ultra Long-Acting Semaglutide Implant For Chronic Weight Management Vivani Medical, Inc. announced full enrollment and successful initial dosing of all participants in its SLIM-1 Phase 1 trial for NPM-139, a miniature, subdermal semaglutide implant being designed to provide six- to twelve-months of continuous drug delivery utilizing proprietary NanoPortal technology. The trial of 20 GLP-1 naïve participants in Australia includes low-doses of NPM-139 and Wegovy to assess safety, tolerability, and pharmacokinetics. Changes in weight will be measured. Dosing of the first 10 participants occurred on July 29, ahead of schedule. The remaining 10 participants were dosed one week later. All insertion procedures were completed successfully without any issues. Top-line data from the 20-participant trial is expected in November of 2026. This milestone follows NPM-139 preclinical studies demonstrating sustainable 20% weight reduction in animal models and a July 2026 agreement with Novo Nordisk to evaluate NPM-139 and Vivani’s proprietary NanoPortal implant technology. NanoPortal implants are uniquely designed to enable infrequent administration (six months or longer) and the ability to rapidly reverse GLP-1 drug exposure when cessation of therapy is needed or desired. Reversibility can be an important clinical consideration in certain situations, including when a woman becomes pregnant or when patients undergoing surgery have an increased aspiration risk. SLIM-1 is an open-label, active-controlled trial evaluating a low-dose NPM-139 (semaglutide implant) given to 10 participants, and the starting dose of Wegovy (0.25mg/week semaglutide injection) also given to 10 participants, over a four-week duration. The trial is designed to evaluate the safety, tolerability and pharmacokinetic profile in overweight or obese participants who are otherwise healthy. Top-line results from SLIM-1 are expected to be available in November. New Risk • Jul 14
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$27m free cash flow). Earnings are forecast to decline by an average of 7.1% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (46% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$38m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Live News • Jul 04
Vivani Medical Subsidiary Cortigent to Merge With ClearOne Forming Cortigent Holdings on Nasdaq Vivani Medical said its wholly owned subsidiary Cortigent, Inc. has entered a merger agreement with a subsidiary of Nasdaq-listed ClearOne, Inc. to form a new company called Cortigent Holdings, Inc., which is expected to continue trading on Nasdaq under the ticker “CRGT.”
The transaction is expected to lower Vivani’s expenditures tied to Cortigent and allow more focus on its drug implant portfolio, while Vivani is expected to retain majority ownership of Cortigent Holdings, which keeps a listed equity currency in the market.
Vivani Medical’s shares trade at $1.26, with the stock up 16.7% over the past 90 days.
This structure gives Vivani a way to separate Cortigent’s funding and development needs from its core drug implant activities while still keeping economic exposure, and it introduces execution risk around closing the merger and integrating Cortigent into the new listed vehicle. 
