Vivani Medical отчиталась о прибыльных результатах и подписала соглашение с Novo Nordisk

Vivani Medical, Inc. (NASDAQ: VANI), a clinical-stage biopharmaceutical company, has reported its second quarter 2026 financial results while announcing significant clinical and commercial progress across its pipeline. All 20 participants in the company’s SLIM-1 Phase 1 trial of NPM-139, a miniature subdermal semaglutide implant, have been successfully dosed ahead of schedule, with top-line data expected in November 2026. The company also signed a non-exclusive agreement with Novo Nordisk to allow the Danish pharmaceutical giant to evaluate NPM-139 and Vivani’s proprietary NanoPortal technology platform. CEO Adam Mendelsohn, Ph.D., described the quarter as one of broad momentum, stating: “We accelerated clinical development of lead asset NPM-139 (semaglutide implant), entered into a non-exclusive agreement with Novo Nordisk enabling them to evaluate NPM-139, and signed a merger agreement with Nasdaq-listed ClearOne.” Mendelsohn added that Vivani “remains the only developer of convenient, ultra-long-acting and reversible GLP-1 candidates with the potential for administration once or twice yearly during a routine primary care office visit.” The SLIM-1 trial, conducted in Australia with 20 GLP-1 naïve participants, compares low doses of NPM-139 against the starting dose of Wegovy, assessing safety, tolerability, pharmacokinetics, and changes in weight over a four-week period. Vivani’s NanoPortal implant technology is designed to maintain continuous therapeutic drug exposure through once- or twice-yearly administration, while retaining the ability to rapidly reverse GLP-1 drug exposure when patients need to cease therapy, such as during pregnancy or ahead of surgery. The company’s agreement with Novo Nordisk, announced July 7, 2026, contains no exclusivity provisions for NPM-139 or the NanoPortal technology, leaving Vivani free to pursue other partnerships simultaneously. On the corporate structure front, Vivani’s wholly owned neurostimulation subsidiary Cortigent, Inc. entered a definitive merger agreement with Nasdaq-listed ClearOne, Inc., with the combined entity expected to trade on the Nasdaq under ticker symbol CRGT as Cortigent Holdings in the third quarter of 2026. The pending merger is designed to establish Cortigent as a separately listed public company, reduce Vivani’s direct expenditure on the subsidiary, and allow Vivani’s management team to focus entirely on its drug implant pipeline. Vivani also appointed August J. Moretti to its board of directors in late June, bringing with him experience as CFO of 4D Molecular Therapeutics and prior executive roles at Assertio Therapeutics, Alexza Pharmaceuticals, and Alavita, Inc., along with a B.A. in Economics from Princeton University and a J.D. from Harvard Law School. On the financial side, Vivani held cash, cash equivalents, and restricted cash totaling $20.8 million as of June 30, 2026, up from $17.6 million at the close of 2025, driven primarily by tranche closings under share purchase agreements and a January 2026 private placement. Research and development expense, net of grants, fell 6% year-over-year to $4.5 million for the second quarter, while general and administrative expense dropped 11% to $2.4 million, reflecting reduced professional services costs across both divisions. Net loss for the three months ended June 30, 2026 narrowed to $6.4 million, compared to $7.1 million in the same period of 2025, as the company continued to manage operating costs while advancing its clinical programs. Looking ahead, Vivani plans to submit an Investigational New Drug application for NPM-139 to support the initiation of a proposed Phase 2 dose-ranging study in 2027, contingent on favorable top-line results from SLIM-1 in November.