Core Insights - Vivani Medical, Inc. is advancing its proprietary NanoPortal™ implant technology through the ongoing LIBERATE-1 study, which has successfully inserted a miniature, ultra long-acting GLP-1 (exenatide) implant in all subjects, with top-line results expected in mid-2025 [1][2][15] - The company has secured its financial position through a new $3 million equity financing, in addition to a previously reported $8.25 million financing, ensuring funding through mid-2026 [1][3] - Promising pre-clinical data for NPM-139 (semaglutide implant) has been released, indicating potential for chronic weight management in obese and overweight patients [1][5] Business Developments - Vivani plans to spin off Cortigent, Inc., a division focused on brain implant devices, into an independent publicly traded company to enhance focus on their respective therapeutic areas [1][8] - The collaboration with Okava Pharmaceuticals has expanded to include dogs in the development of a long-acting GLP-1 therapy, OKV-119, leveraging Vivani's NanoPortal technology [4] Financial Performance - As of March 31, 2025, Vivani reported a cash balance of $14.3 million, down from $19.7 million at the end of 2024, primarily due to a net loss of $6.3 million [10] - Research and development expenses increased by 13% to $4.2 million compared to the same period in 2024, reflecting heightened activity in the Biopharma division [11] - General and administrative expenses decreased by 6% to $2.3 million, attributed to reduced professional services and personnel costs [12] Market Position and Strategy - The GLP-1 market is growing, but new entrants must differentiate themselves due to the established clinical benefits of existing therapies; Vivani's miniature, long-acting implants aim to improve medication adherence and patient outcomes [2][16] - The company anticipates that its differentiated portfolio of GLP-1 implants will provide a compelling alternative treatment option for patients and healthcare providers [2][16]

Core Viewpoint - Vivani Medical, Inc. is advancing its innovative miniature drug implants aimed at improving patient adherence in chronic disease treatment, particularly in the GLP-1 drug class [1][4][5] Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing ultra long-acting drug implants using its proprietary NanoPortal™ technology [1][4] - The company's lead programs include NPM-115 (exenatide implant) for weight management and NPM-139 (semaglutide implant) for chronic weight management, both designed for infrequent administration [4] Upcoming Events - CEO Adam Mendelsohn will present at the AAPS workshop on May 14, 2025, discussing advances in drug delivery and patient adherence [2][3] - The presentation will focus on the company's lead program, NPM-115, with results from the LIBERATE-1™ study expected this year [2] Industry Context - Medication non-adherence affects approximately 50% of patients, contributing to over $500 billion in avoidable healthcare costs and 125,000 preventable deaths annually in the U.S. [5] - The current GLP-1 landscape includes over 50 new molecular entities in clinical development, highlighting the competitive environment in which Vivani operates [5]

Core Viewpoint - Vivani Medical, Inc. is advancing its miniature, ultra long-acting drug implants aimed at improving patient adherence in chronic disease treatment, particularly in the GLP-1 drug class [1][4][5] Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutic implants using its proprietary NanoPortal™ technology [4] - The company’s lead programs include NPM-115 (exenatide implant) and NPM-139 (semaglutide implant), designed for chronic weight management with administration once or twice a year [4] - Vivani is also developing NPM-119, a six-month GLP-1 implant for type 2 diabetes treatment [4] Upcoming Events - CEO Adam Mendelsohn will present on "Addressing Patient Adherence: Advances in Drug Delivery" at the AAPS workshop on May 14, 2025 [2] - A panel discussion featuring Dr. Mendelsohn will address key hurdles and trends in GLP-1 drug development on the same day [3] Market 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. [5] - The current GLP-1 landscape includes over 50 new molecular entities in clinical development, positioning Vivani's differentiated portfolio as a potential attractive option for patients and healthcare providers [5]

Core Insights - Vivani Medical, Inc. is developing miniature, ultra long-acting GLP-1 implants for chronic weight management and type 2 diabetes, with topline data from the LIBERATE-1 clinical trial expected in mid-2025 [1][2][3] Company Overview - Vivani Medical utilizes its proprietary NanoPortal platform to create therapeutic implants that deliver drug molecules steadily over extended periods, aiming to improve patient adherence and tolerance [3] - The company's lead programs include NPM-139 (semaglutide implant) and NPM-115 (exenatide implant), designed for once or twice-yearly administration for chronic weight management [3] - Vivani is also developing NPM-119, a six-month subdermal GLP-1 implant for type 2 diabetes treatment, and is considering a semaglutide implant for the same condition [3] Clinical Trial Information - The LIBERATE-1 trial is a first-in-human study of the NPM-115 implant, with results anticipated in mid-2025 [2][3] - The company is actively engaging with investors and stakeholders through events such as a virtual fireside chat scheduled for April 24, 2025 [2] 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] - Vivani's differentiated portfolio of GLP-1 implants aims to address the challenges of medication adherence faced by patients with obesity and type 2 diabetes [4]

Core Insights - Vivani Medical, Inc. is developing miniature, ultra long-acting GLP-1 implants for chronic weight management and type 2 diabetes, with topline data from the LIBERATE-1 clinical trial expected in mid-2025 [1][2][3] Company Overview - Vivani Medical utilizes its proprietary NanoPortal platform to create therapeutic implants that deliver drug molecules steadily over extended periods, aiming to improve medication adherence and patient tolerance [3] - The company's lead programs include NPM-139 (semaglutide implant) and NPM-115 (exenatide implant), designed for once or twice-yearly administration for chronic weight management [3] - Vivani is also developing NPM-119, a six-month subdermal GLP-1 implant for type 2 diabetes treatment, and is considering a semaglutide implant for the same condition [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 includes over 50 new molecular entities in clinical development, but Vivani's differentiated portfolio of miniature, ultra long-acting GLP-1 implants is positioned as a promising therapeutic option [4]

Core Insights - Vivani Medical and Okava Pharmaceuticals are expanding their collaboration to develop OKV-119, a long-acting GLP-1 therapy for weight management and cardiometabolic conditions in dogs, building on their initial partnership focused on cats [1][3][4] Company Overview - Vivani Medical is a clinical-stage biopharmaceutical company specializing in miniature, ultra long-acting drug implants, utilizing its proprietary NanoPortal™ technology for steady drug delivery [1][5] - Okava Pharmaceuticals focuses on developing treatments for chronic diseases in aging dogs and cats, aiming to enhance the quality of veterinary care [1][8] Product Development - OKV-119 is designed to mimic the physiological effects of caloric restriction, improving insulin sensitivity and energy metabolism without altering feeding routines [3] - The product aims to address the issue of obesity in dogs, with over half of U.S. dogs classified as overweight or obese, which can lead to chronic diseases and reduced lifespans [3] Market Potential - The collaboration reflects a growing market for veterinary medicine, with Vivani's technology positioned to meet unmet needs and capture future value in this expanding industry segment [4] - Vivani's lead programs include NPM-139 and NPM-115, both GLP-1 implants for chronic weight management in humans, indicating a broader application of their technology [5][7] Financial Aspects - The financial terms of the expanded collaboration were not disclosed, but the partnership is structured to minimize costs and risks for Vivani while providing potential future milestone payments and royalties [4]

Product Development - Vivani Medical is developing a portfolio of miniature, subdermal drug implants aimed at improving medication adherence for chronic diseases, with a focus on delivering therapeutic drug levels for up to six months or longer [405][406]. - The lead program, NPM-115, is a six-month GLP-1 (high-dose exenatide) implant currently in clinical-stage testing for chronic weight management in obese and overweight individuals [407]. - In February 2024, Vivani announced positive preclinical weight loss data showing approximately 20% weight loss in obese mice with the exenatide implant, comparable to semaglutide [415]. - The company has filed an IND for NPM-119 (GLP-1 implant) with the FDA, which was initially on clinical hold but was lifted on June 13, 2024, allowing the study to proceed [412][420]. - Vivani established a wholly owned subsidiary, Vivani Medical Australia Pty Ltd., in the fourth quarter of 2023 to support studies of its product candidates [414]. - The company reported receiving regulatory approval to initiate its first-in-human clinical trial, LIBERATE-1, for the GLP-1 implant in Australia, with data expected in mid-2025 [424][426]. - Vivani's GLP-1 (exenatide) implant demonstrated an 82% reduction in liver fat in preclinical studies, indicating potential for significant health benefits in chronic weight management [422]. Financial Performance - The net loss for the year ended December 31, 2024, was $23.5 million, a reduction of $2.2 million compared to a net loss of $25.7 million in 2023 [450]. - Research and development expenses for the year ended December 31, 2024, were $15.7 million, a decrease of 7% from $17.0 million in 2023 [446]. - General and administrative expenses decreased by 11% to $8.9 million in 2024, down from $10.0 million in 2023 [448]. - The Company has experienced recurring operating losses and negative operating cash flows since inception, relying on equity securities sales for working capital [437]. - The company expects to continue incurring operating losses and negative cash flows for the foreseeable future [456]. Cash Flow and Financing - Cash, cash equivalents, and restricted cash decreased by $2.3 million from $22.0 million as of December 31, 2023, to $19.7 million as of December 31, 2024 [459]. - Working capital was $14.5 million as of December 31, 2024, compared to $17.3 million as of December 31, 2023 [459]. - Cash used in operating activities during 2024 was $20.8 million, primarily due to a net loss of $23.5 million [460]. - Cash used in operating activities during 2023 was $23.7 million, primarily due to a net loss of $25.7 million [461]. - Net cash used in investing activities during 2024 was $0.6 million for the purchase of equipment [462]. - Financing activities provided $19.1 million of cash in 2024, primarily from securities purchase agreements [463]. - Financing activities provided $0.1 million of cash in 2023, primarily from stock option exercises [464]. - The company anticipates seeking funding through public or private equity or debt financings, grants, collaborations, and strategic partnerships [458]. Capital Raising Activities - On March 1, 2024, Vivani entered into a securities purchase agreement to sell 3,947,368 shares of common stock at a price of $3.80 per share, raising significant capital [417]. - The Company raised gross proceeds of $15.0 million from a registered direct offering of 3,947,368 shares at a price of $3.80 per share, resulting in net proceeds of $13.7 million after issuance costs of $1.3 million [430]. - The Company entered into a Sales Agreement with Jefferies LLC to offer and sell shares of common stock with an aggregate offering price of up to $75.0 million [431]. - During the twelve months ended December 31, 2024, the Company issued 287,970 shares under the Sales Agreement, generating net proceeds of $160,000 after expenses of $344,000 [432]. - A private sale transaction on November 8, 2024, resulted in gross proceeds of $5.0 million from the sale of 3,968,253 shares at a price of $1.26 per share [425]. - Another private sale transaction on March 26, 2025, is expected to generate approximately $8.25 million from the sale of 7,366,071 shares at a price of $1.12 per share [435]. Future Outlook - The company estimates that currently available cash will be sufficient to meet its planned obligations for at least the next twelve months [439]. - The company has not entered into foreign currency forward contracts to hedge operating expense exposure to foreign currencies [468]. - The company aims to create two focused entities through the spin-off of Cortigent, which will allow for dedicated development in their respective therapeutic areas [409].

Successful initial administration and full enrollment in first-in-human LIBERATE-1™ study of NPM-115 (exenatide implant) in obese and overweight subjects with top-line data expected in mid-2025 In response to the recent positive preclinical weight loss data with NPM-139, Vivani is now planning to advance NPM-139 towards clinical phase development in addition to the ongoing NPM-115 program. Recent Business Highlights On March 27, 2025, Vivani announced an $8.25 million equity financing which secures solid fi ...

Core Viewpoint - Vivani Medical, Inc. has announced a private placement of 7,366,071 shares at $1.12 per share, expected to generate approximately $8.25 million in gross proceeds, which will extend its cash runway into the second quarter of 2026 and support the accelerated development of its GLP-1 implants for chronic weight management [1][2][3]. Group 1 - The private placement will enable the accelerated development of NPM-139, a GLP-1 (semaglutide) implant, and continued development of NPM-115, a GLP-1 (exenatide) implant, both aimed at chronic weight management [2][6]. - The securities purchase agreement was made with an entity owned by Gregg Williams, the Chairman of the Company's board, and the placement was priced "at-the-market" under Nasdaq regulations [3][4]. - The securities sold in this private placement have not been registered under the Securities Act of 1933 and may not be offered or sold in the U.S. without an effective registration statement or applicable exemption [4][5]. Group 2 - Vivani Medical is focused on developing miniature, ultra long-acting drug implants using its proprietary NanoPortal™ platform, which aims to improve medication adherence and patient tolerance [6]. - The company's lead program, NPM-115, is a six-month subdermal GLP-1 (exenatide) implant for chronic weight management, while NPM-139 is being developed as a twice-yearly implant with potential for once-yearly administration [6]. - Medication non-adherence affects approximately 50% of patients, contributing to over $500 billion in annual avoidable healthcare costs in the U.S., highlighting the need for innovative delivery systems like Vivani's implants [6].

NanoPortal™ technology successfully delivers semaglutide, the active ingredient in Ozempic®/Wegovy®, in a preclinical study with NPM-139 (semaglutide implant) NPM-139 treatment resulted in nearly 20% placebo-adjusted weight loss from a single administration with expected once or twice-yearly dosing NPM-139 is a miniature, subdermal implant in development for chronic weight management designed to guarantee medication adherence and potentially improve treatment tolerability by providing smooth and steady deli ...