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ALAMEDA, Calif. - Vivani Medical, Inc. (NASDAQ:VANI), a $68.7 million market cap biotech company, announced plans to initiate a Phase 1 clinical study for its semaglutide implant program NPM-139 in the first half of 2026, pending regulatory clearance. According to InvestingPro data, analysts have set an ambitious $4 target price for the stock, suggesting significant upside potential if development milestones are met.
The clinical program will evaluate the investigational implant for chronic weight management in patients who are obese or overweight with related comorbidities. According to the company’s press release, Vivani is also preparing to launch a Phase 2 clinical study pending results from the Phase 1 trial. InvestingPro analysis reveals the company is currently operating at a negative EBITDA of $26.4 million, reflecting its development-stage status.
The Phase 1 study will assess safety, tolerability, and pharmacokinetic profile of the semaglutide implant in GLP-1 naïve subjects, with a control arm receiving low-dose Wegovy injected weekly.
"Recent promising results from LIBERATE-1, the first-in-human study of NPM-115, an exenatide implant utilizing NanoPortal technology, combined with positive preclinical weight loss data with NPM-139, compel us to move forward aggressively with clinical development of NPM-139," said Vivani President and CEO Adam Mendelsohn.
The company claims its implant could potentially provide efficacy comparable to Wegovy with once or twice-yearly administration, which would differentiate it in the growing GLP-1 market for weight management. With a weak financial health score according to InvestingPro, which offers 7 additional key insights about the company’s prospects, successful development of this product could be crucial for Vivani’s future.
The planned Phase 2 study is expected to be a randomized, placebo-controlled, dose-ranging investigation over 4 to 6 months to evaluate the effects of the semaglutide implant on weight management.
Vivani’s NanoPortal platform is designed to deliver drug molecules steadily over extended periods to improve medication adherence and patient tolerance. The company is developing a portfolio of GLP-1 based implants for chronic weight management and other metabolic diseases.
In other recent news, Vivani Medical, Inc. has secured $10 million in equity financing to further develop its semaglutide implant NPM-139. This funding, sourced from two investors including an entity owned by Chairman Gregg Williams, is expected to extend the company’s financial runway into the second half of 2026. Additionally, at the company’s 2025 Annual Meeting of Stockholders, shareholders elected all six nominees to the board of directors to serve until the 2026 annual meeting. In a notable leadership change, Vivani Medical has appointed Anthony Baldor as the new Chief Financial Officer, replacing Brigid A. Makes, who is retiring. Baldor brings over 20 years of financial management experience in the biotechnology sector, having previously served at Diakonos Oncology Corp. and 4D Molecular Therapeutics, Inc. These developments reflect Vivani Medical’s ongoing strategic and financial initiatives.
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