semaglutide implant (NPM-139) / Vivani Medical - LARVOL DELTA

Vivani Medical Announces Successful Dosing of All Participants in SLIM-1, a Phase 1 Trial Evaluating NPM-139, a Miniature, Ultra Long-Acting Semaglutide Implant for Chronic Weight Management (The Manila Times) - "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...'We look forward to sharing top-line SLIM-1 clinical data later this year which we anticipate will pave the way for initiation of a Phase 2 dose-ranging trial in 2027.'"

New P2 trial • P1 data • Trial status • Obesity

Vivani Medical…announced the signing of a new agreement with Novo Nordisk to enable Novo Nordisk to evaluate NPM-139, the Company’s semaglutide drug implant. NPM-139, which utilizes Vivani’s NanoPortal platform technology, is under development for chronic weight management (GlobeNewswire) - "There are no exclusivity provisions for NPM-139, or Vivani’s proprietary NanoPortal technology associated with this agreement....Separately, Vivani expects to initiate a Phase 1, randomized, first-in-human study evaluating the NPM-139 semaglutide implant, with Wegovy injections as an active comparator, in mid-2026. The study’s objectives are to characterize the safety, pharmacokinetics, and tolerability of NPM-139 to support the initiation of a Phase 2 dose-ranging study pending successful results of the Phase 1 study."

Licensing / partnership • New P1 trial • Obesity

SLIM-1: Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Vivani Medical, Inc | Trial completion date: Sep 2026 ➔ Jan 2027 | Initiation date: Apr 2026 ➔ Jul 2026 | Trial primary completion date: Aug 2026 ➔ Dec 2026

Trial completion date • Trial initiation date • Trial primary completion date • Genetic Disorders • Obesity

Vivani Medical Receives Regulatory Approval for the Initiation of SLIM-1, a Phase 1 Clinical Trial of NPM-139 Semaglutide Implant in Obesity and Chronic Weight Management (GlobeNewswire) - "'HREC approval to initiate SLIM-1 in Australia marks an important moment for our Company, clearing the way for near-term, mid-2026, initiation'....SLIM-1 (Semaglutide ultra Long-acting IMplant in obesity) is a Phase 1 open label, randomized, active comparator-controlled clinical trial evaluating a low-dose NPM-139 (semaglutide NanoPortal implant) and Wegovy (0.25 mg/week) over a four-week duration in obese or overweight subjects (n=10 per group)."

Trial status • Obesity

Upcoming Anticipated Milestones (Yahoo Finance) - "Initiation of SLIM-1, a Phase 1 study of low-dose NPM-139, Vivani’s miniature, ultra long-acting semaglutide implant under development for chronic weight management, anticipated mid-2026 and top-line results are projected by the end of 2026....Investigational New Drug ('IND') Application for NPM-139 to support initiation of the proposed Phase 2 dose-ranging study of this semaglutide implant planned for 2027."

IND • New P2 trial • Trial status • Obesity

Vivani Medical Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update (GlobeNewswire) - "..Vivani announced plans to prioritize advancement of NPM-139, with clinical development expected to begin in 2026...The Company also announced parallel preparations to initiate a Phase 2 clinical study of NPM-139 pending enabling results from the Phase 1 study and regulatory feedback. The Company anticipates initiating the Phase 1 study in mid-2026...Phase 1 study results for low-dose NPM-139, Vivani’s miniature, ultra long-acting semaglutide implant under development for chronic weight management, by the end of 2026....Investigational New Drug Application for NPM-139 to support the proposed Phase 2 dose-ranging study of this semaglutide implant."

IND • New P1 trial • New P2 trial • P1 data • Obesity

SLIM-1: Safety, Tolerability and Pharmacokinetics of a Subcutaneous Semaglutide Implant (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Vivani Medical, Inc

New P1 trial • Genetic Disorders • Obesity

Vivani Medical Provides Business Update… (GlobeNewswire) - "Upcoming Anticipated Milestones: Vivani anticipates initiating clinical development of a semaglutide implant, NPM-139, in obesity and chronic weight management in 2026."

New trial • Obesity

Vivani Medical Provides Update on Clinical Development Plans for NPM-139 Semaglutide Implant for Chronic Weight Management (GlobeNewswire) - "Vivani Medical...announced plans to initiate a Phase 1 clinical study in the NPM-139 semaglutide implant program in the first half of 2026, pending regulatory clearance. The Company is also preparing to initiate a Phase 2 clinical study of NPM-139 pending enabling results from the Phase 1 study and regulatory feedback."

New trial • Obesity

Upcoming Anticipated Milestones (GlobeNewswire) - "(i) Vivani anticipates providing a more detailed NPM-139 program update later this year, which will include the proposed design of the NPM-139 clinical program through a dose-ranging weight maintenance study outcome; (ii) Vivani anticipates initiating clinical development of NPM-139 in 2026."

Clinical • New trial • Obesity

Semaglutide Implant Preclinical Feasibility Data (GlobeNewswire) - "Based on these data, Vivani prioritizes the advancement of NPM-139, with clinical development expected to begin in 2026, pending regulatory clearance...In an ongoing preclinical study, substantial progress in the development of a miniature, ultra long-acting, semaglutide implant, NPM-139 has been established by showing weight loss from a single administration for over 231 days....Vivani’s near-term efforts are focused on completion of PK optimization activities and preparation of data to enable the submission of an Investigational New Drug application for NPM-139."

New trial • Preclinical • Obesity

Vivani Medical Announces $8.25M Private Placement Equity Financing (GlobeNewswire) - "The Company expects the gross proceeds from this private placement to extend its cash runway into the second quarter of 2026, enabling accelerated development of NPM-139, its once or twice-yearly GLP-1 (semaglutide) implant under development for chronic weight management, and continued development of NPM-115, its twice-yearly GLP-1 (exenatide) implant which is also under development for chronic weight management."

Financing • Obesity

Vivani Medical Announces Positive Preclinical Weight Loss Data for NPM-139 Semaglutide Implant, with Potential for Once-Yearly Dosing (GlobeNewswire) - "Vivani Medical...today announced promising preclinical data for NPM-139, its subdermal semaglutide implant under development for chronic weight management in obese and overweight individuals....'We continue to believe that the primary expected advantages of our proprietary NanoPortal implant technology, improving medication adherence and medication tolerability, have the potential to transform and expand the adoption of GLP-1 therapy in the future,'...In an ongoing study in healthy rats, a single administration of the semaglutide implant NPM-139 resulted in body weights that were nearly 20% lower than a sham implant control group throughout a 91-day treatment period."

Preclinical • Obesity