ALAMEDA, Calif., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, announced today that CEO Adam Mendelsohn, Ph.D., will present a company overview and conduct partnering meetings at the H.C. Wainwright 27th Annual Global Investment Conference, taking place from September 8-10, 2025 in New York, New York. Details of Dr. Mendelsohn’s presentation are as follows: D ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-36747 Vivani Medical, Inc. (Exact name of registrant as specified in its charter) Delaware 02-0692322 (State or ...

Company plans rapid advancement of semaglutide implant NPM-139, following positive weight loss data from an ongoing preclinical study of NPM-139 and promising results from the LIBERATE-1 Phase 1 clinical study of NPM-115 New $10M equity financing to enable accelerated development of NPM-139 while securing financial position into the second half of 2026 Vivani to spin off Cortigent, Inc., a division of the Company that develops brain implant devices to help patients recover critical body functions, as an ind ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K (Telephone number, including area code, of agent for service) (Former name or former address, if changed since last report.) CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 5, 2025 Vivani Medical, Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-36747 02-0692322 (State or Other Jurisdiction of Incorporation) (C ...

Core Insights - Vivani Medical, Inc. has reported positive results from the LIBERATE-1 clinical study, which is the first-in-human application of its NanoPortal implant technology, demonstrating a favorable safety and tolerability profile for the NPM-115 implant [1][3][4] - The company has also presented preclinical feasibility data for the NPM-139 semaglutide implant, indicating approximately 20% weight loss maintained for over 6 months with a single implant, supporting the potential for annual dosing [1][2][3] - Based on these findings, Vivani is prioritizing the advancement of NPM-139, with clinical development expected to commence in 2026, pending regulatory clearance [1][3][11] LIBERATE-1 Study Results - The LIBERATE-1 Phase 1 study successfully met its primary objectives, evaluating the safety and tolerability of the NPM-115 implant and characterizing its pharmacokinetic profile over a 9-week duration [4][5] - The study found that the implant was generally well tolerated, with no serious adverse events reported, and the drug release profile showed promise for durable delivery over a 6-month period [4][5] NPM-139 (Semaglutide Implant) Development - The preclinical study for NPM-139 has shown significant weight loss results, with a single administration leading to weight loss sustained for over 231 days [7][11] - The company believes that the development timelines for NPM-115 and NPM-139 are comparable, and the established success of semaglutide products in the market supports the confidence in NPM-139 [3][12] - Semaglutide-based products, including Ozempic, Wegovy, and Rybelsus, generated over $29 billion in sales in 2024, indicating strong commercial potential for NPM-139 [3][12]

Core Insights - Vivani Medical, Inc. has appointed Anthony Baldor as Chief Financial Officer, succeeding Brigid A. Makes, who is retiring to focus on other commitments [1][3] - Baldor has over 20 years of financial management experience in the biotechnology sector, with a strong background in fundraising and corporate strategy [2] - The CEO of Vivani, Adam Mendelsohn, expressed confidence in Baldor's expertise to advance the company's pipeline and operations during a critical period [3] Company Overview - Vivani Medical develops miniature, ultra long-acting drug implants using its proprietary NanoPortal™ platform, aimed at improving medication adherence and patient tolerance [4] - The lead program, NPM-115, is a six-month GLP-1 implant for chronic weight management, with additional products in the pipeline, including NPM-139 and NPM-119, targeting similar therapeutic areas [4] - Medication non-adherence affects approximately 50% of patients, contributing to over $500 billion in annual avoidable healthcare costs and 125,000 preventable deaths in the U.S. [4]

Core Viewpoint - Vivani Medical, Inc. is preparing to present its innovative drug implant technology at the 2025 BIO International Convention, highlighting its potential to improve medication adherence and patient outcomes in chronic disease management [1][4]. Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing miniature, ultra long-acting drug implants using its proprietary NanoPortal™ technology [3]. - The company's lead program, NPM-115, is a six-month GLP-1 (exenatide) implant aimed at chronic weight management for obese or overweight individuals [1][3]. - Vivani's emerging pipeline includes NPM-139 (semaglutide implant) and NPM-119, both designed for chronic weight management and type 2 diabetes treatment, respectively [3]. Industry Context - Medication non-adherence affects approximately 50% of patients, contributing to over $500 billion in annual avoidable healthcare costs and 125,000 preventable deaths in the U.S. [4]. - The current GLP-1 landscape features over 50 new molecular entities in clinical development, with Vivani's differentiated portfolio of miniature implants positioned as a promising therapeutic option [4].

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ | Title of Each Class | Trading Symbol | Name of Each Exchange on Which Registered | | --- | --- | --- | | Common Stock, par value $0.0001 ...

Exhibit 10.1 SHARE PURCHASE AGREEMENT This Share Purchase Agreement (this "Agreement") is dated as of May 12, 2025 (the "Execution Date"), by and between Vivani Medical, Inc., a Delaware corporation (the "Company") and Gregg G Williams 2006 Irrevocable Trust (the "Purchaser"). The Company and the Purchaser are each hereafter referred to individually as a "Party" and together as the "Parties." RECITALS WHEREAS, subject to the terms and conditions set forth in this Agreement, the Company desires to issue and ...