Core Viewpoint - Vivani Medical, Inc. has announced a temporary withdrawal of the previously set record date for the spin-off of its subsidiary Cortigent, due to delays caused by the U.S. federal government shutdown [1][2]. Group 1: Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing miniature, ultra long-acting drug implants [1]. - The company utilizes its proprietary NanoPortal™ platform to create biopharmaceutical implants aimed at delivering drug molecules steadily over extended periods, enhancing patient adherence and tolerance [3]. - Vivani is developing a portfolio of GLP-1 based implants targeting metabolic diseases such as obesity and type 2 diabetes [3]. Group 2: Cortigent Overview - Cortigent, a wholly-owned subsidiary of Vivani, is focused on developing brain implant devices that utilize advanced neuromodulation technology to aid patients in recovering critical body functions [2]. - The Orion Visual Cortical Prosthesis System, an investigational system by Cortigent, is designed to treat blindness from common conditions like glaucoma and diabetic retinopathy, and has received FDA Breakthrough Device designation [2]. - Cortigent's technology also aims to improve recovery of arm and hand motion in patients with paralysis due to stroke [2]. Group 3: Financial Advisory - ThinkEquity is serving as the exclusive financial advisor to Cortigent regarding the spin-off transaction [2].

Core Viewpoint - Vivani Medical, Inc. plans to spin off its subsidiary Cortigent, Inc. into an independent publicly traded company on Nasdaq by the third quarter of 2025, aiming to enhance value for both Vivani and Cortigent stockholders [1][3][6] Company Developments - Cortigent is developing the Orion Visual Cortical Prosthesis System to provide visual perception for the blind and a Stroke Recovery System to aid recovery of arm and hand movement post-stroke [1][8] - The Orion system has received FDA Breakthrough Device designation and completed a six-year Early Feasibility Study with promising results [2][8] - Cortigent's previous product, the Argus II, was the first FDA-authorized artificial vision device, successfully implanted in hundreds of patients [2][8] Strategic Focus - The spin-off will allow Vivani to concentrate on its proprietary NanoPortal drug implant technology, specifically for chronic weight management and type 2 diabetes [1][2][3] - Vivani's lead program includes a six-month subdermal GLP-1 implant for chronic weight management, with additional products in development for type 2 diabetes [9][11] Financial and Operational Structure - The spin-off is expected to provide clearer visibility into the financial and operational structures of both companies, enhancing understanding of their respective strategies and risks [5][10] - The transaction is subject to various conditions, including board approval and SEC and Nasdaq compliance [6] Management and Leadership - Cortigent's CEO, Jonathan Adams, has extensive experience in the biopharmaceutical field and aims to accelerate the development of Cortigent's technologies post-spin-off [2][8]

Core Insights - Vivani Medical, Inc. has successfully initiated the LIBERATE-1 study for its NPM-115 (exenatide implant) with full enrollment achieved, expecting top-line data in mid-2025 [1][4] - The company reported promising preclinical data for NPM-139 (semaglutide implant), indicating potential for once-yearly dosing comparable to existing treatments [1][3] - An additional $8.25 million in equity financing has been secured, ensuring financial stability into Q2 2026 to support ongoing development of NPM-115 and NPM-139 [1][3] Company Developments - Vivani transitioned to a clinical-stage biotechnology company in 2024, achieving significant milestones in its NPM-115 and NPM-139 programs [2] - The LIBERATE-1 study has successfully administered its first GLP-1 implant, addressing medication adherence challenges in chronic weight management and type 2 diabetes [4] - The company is advancing NPM-139 towards clinical phase development alongside the ongoing NPM-115 program [2][3] Financial Performance - As of December 31, 2024, Vivani reported a cash balance of $19.7 million, down from $22.0 million in 2023, primarily due to a net loss of $23.5 million [10] - Research and development expenses for Q4 2024 were $4.3 million, a decrease of 9% from $4.7 million in Q4 2023 [11] - General and administrative expenses increased by 43% to $2.1 million in Q4 2024 compared to $1.5 million in Q4 2023, attributed to higher professional services and stock-based compensation [12] Future Outlook - Key milestones for the LIBERATE-1 trial are anticipated, including the last subject implanted and top-line results expected in mid-2025 [15] - Vivani plans to file an Investigational New Drug Application for NPM-139 and advance its clinical trials [15] - The company is also preparing for the spin-off of its subsidiary Cortigent into an independent publicly traded company [5][15]