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].

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]

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 ...

Core Viewpoint - Vivani Medical (VANI) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are closely correlated with stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [4][6]. - For Vivani Medical, the upgrade reflects an improvement in the company's underlying business, suggesting that investor sentiment may drive the stock price higher [5][10]. Earnings Estimate Revisions - Vivani Medical is projected to earn -$0.43 per share for the fiscal year ending December 2024, representing a year-over-year change of 14% [8]. - Over the past three months, the Zacks Consensus Estimate for Vivani Medical has increased by 4.9%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating, highlighting their potential for market-beating returns [9][10]. - The upgrade of Vivani Medical to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a favorable outlook for the stock in the near term [10].

Financial Position - As of December 31, 2024, Vivani Medical had approximately $18.4 million in cash and cash equivalents, excluding restricted cash[5]. Clinical Trials - The company announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial, with full enrollment achieved in just four weeks[16]. - Top-line results from the LIBERATE-1 study are expected to be available by mid-2025, reaffirming previous estimates[11]. - The LIBERATE-1 study is exploring the pharmacokinetic profile of NPM-115, which has shown smooth drug release in preclinical studies[17]. Business Strategy - The company plans to spin off its Cortigent neurostimulation business, with the transaction expected to be completed by mid-2025, subject to certain conditions[11]. - The spin-off is intended to be tax-free for U.S. federal income tax purposes, with shares distributed to stockholders[14]. - ThinkEquity LLC is acting as the exclusive financial advisor for the Cortigent spin-off transaction[15]. Product Development - Cortigent aims to provide artificial vision for blind individuals through precision neurostimulation technology, having previously commercialized the Argus II Retinal Prosthesis System[13]. - The company is leveraging its core technology for other indications, including recovery of arm and hand motion in paralysis due to stroke[13]. Risks and Forward-Looking Statements - Forward-looking statements indicate potential risks related to the spin-off and product development, including regulatory approvals and market conditions[18].

Core Viewpoint - Vivani Medical, Inc. plans to spin off Cortigent, Inc., a division focused on brain implant devices, into an independent publicly-traded company to enhance shareholder value [1][3]. Company Developments - The spin-off will enable Vivani to concentrate on developing GLP-1 implants for chronic weight management and type 2 diabetes, while Cortigent will focus on precision neurostimulation technology for artificial vision [4]. - Jonathan Adams will continue as CEO of Cortigent post-spin-off [4]. Industry Insights - There is a growing interest in neurostimulation technology, influenced by companies like Neuralink, with the global neurostimulation market expanding due to the rise in chronic diseases and technological advancements [2]. - Cortigent's Orion Cortical Visual Prosthesis System has received FDA Breakthrough Device designation and aims to treat blindness from various conditions [6][7]. - The spin-off is expected to be completed by Q3 2025 [7].

Product Development - Vivani Medical, Inc. is focused on developing NPM-115, a miniature GLP-1 implant for chronic weight management, targeting a weight loss of approximately 20% in preclinical studies[119] - An Investigational New Drug Application for NPM-119 was filed with the FDA on July 14, 2023, and the IND was cleared on June 13, 2024, allowing for the initiation of first-in-human studies[116][124] - Vivani's NanoPortal™ technology allows for miniaturized implants to deliver therapeutic drugs for up to six months, minimizing fluctuations in drug levels[113] - The LIBERATE-1 clinical trial is set to investigate the safety and pharmacokinetics of the exenatide implant, with data expected in 2025[125][127] - In a preclinical study, Vivani's GLP-1 implant demonstrated an 82% reduction in liver fat in obese mice, indicating potential efficacy for chronic weight management[126] Financial Performance - The Company raised gross proceeds of $15.0 million from the issuance of 3,947,368 shares of common stock at a purchase price of $3.80 per share on March 1, 2024, resulting in net proceeds of $13.7 million after issuance costs[128] - The Company entered into an Open Market Sale Agreement with Jefferies LLC to offer and sell shares of common stock with an aggregate offering price of up to $75.0 million[129] - Research and development expenses for the three months ended September 30, 2024, were $4.2 million, a decrease of $0.2 million, or 5%, compared to $4.4 million for the same period in 2023[140] - General and administrative expenses for the three months ended September 30, 2024, were $2.1 million, a decrease of $0.6 million, or 22%, compared to $2.7 million for the same period in 2023[141] - The Company used $15.0 million of cash in operating activities during the nine months ended September 30, 2024, consisting primarily of a net loss of $17.4 million[153] - Cash, cash equivalents, and restricted cash decreased by $1.0 million from $22.0 million as of December 31, 2023, to $21.0 million as of September 30, 2024[153] - Working capital decreased by $2.2 million from $17.3 million as of December 31, 2023, to $15.1 million as of September 30, 2024[153] - The Company expects to continue incurring operating losses and negative operating cash flows for the foreseeable future[151] - The Company anticipates that currently available cash will be sufficient to meet its planned obligations for at least the next twelve months[134] - The Company received grants totaling $0.2 million and $0.4 million during the nine months ended September 30, 2024, and 2023, respectively, to offset operating expenses[131] - Cash used for investing activities was $0.3 million for the nine months ended September 30, 2024, compared to $0.1 million in the same period of 2023, primarily for property and equipment purchases[154] - Cash provided by financing activities was $14.2 million during the nine months ended September 30, 2024, mainly due to a securities purchase agreement with an institutional investor[154] - Cash provided by financing activities was $110,000 during the nine months ended September 30, 2023, from the exercise of options[155] Corporate Structure and Strategy - Vivani established a wholly-owned subsidiary, Vivani Medical Australia Pty Ltd., to support studies of its product candidates in Australia[118] - The company has committed to advancing its neurostimulation technology through its subsidiary Cortigent, which is preparing for an initial public offering[114] - Vivani's management team is exploring strategic options to further develop its pioneering neurostimulation systems from legacy company Second Sight[110] Cash Management - As of September 30, 2024, the company had no off-balance sheet arrangements[157] - The company invests excess cash in certificates of deposit and money market funds to maintain principal safety and liquidity[157] - The majority of operating expenses were denominated in U.S. dollars, with no foreign currency forward contracts currently in place to hedge exposure[158] Market Challenges - The company reported that 64% of patients discontinue therapy with Wegovy® within the first year, highlighting the need for improved medication adherence solutions[109]

Financial Position - Vivani Medical announced a $5 million equity financing, securing its financial position into late 2025 to support the completion of its first-in-human study and data read-out[1]. - The company reported a cash balance of $21.0 million as of September 30, 2024, down from $26.3 million as of June 30, 2024, primarily due to a net loss of $6.0 million[9]. Operating Expenses - Research and development expenses for Q3 2024 were $4.2 million, a decrease of 5% from $4.4 million in Q3 2023, attributed to staffing reductions and reduced use of outside services[10]. - General and administrative expenses decreased by 22% to $2.1 million in Q3 2024 from $2.7 million in Q3 2023, due to staffing reductions and lower professional service costs[11]. - Total operating expenses for the three months ended September 2024 were $6,309,000, a decrease of 11.7% from $7,144,000 in the same period of 2023[19]. - Total operating expenses for the nine months ended September 2024 were $18,217,000, down from $20,748,000 in the same period of 2023, reflecting a decrease of 12.2%[19]. - The company continues to focus on reducing operating expenses while managing research and development costs effectively[19]. Net Loss - The net loss for Q3 2024 was $6.0 million, an improvement from a net loss of $6.8 million in Q3 2023, reflecting a decrease in operating expenses[12]. - Net loss for the three months ended September 2024 was $6,041,000, compared to a net loss of $6,782,000 for the same period in 2023, reflecting a 10.9% improvement[19]. - Net loss per common share for the three months ended September 2024 was $(0.11), an improvement from $(0.13) in the same period of 2023[19]. - Net loss for the nine months ended September 2024 was $17,436,000, an improvement from $19,626,000 in the same period of 2023, indicating a reduction of 11.1%[19]. Clinical Studies and Pipeline - The company received regulatory approval to initiate its first-in-human clinical study, LIBERATE-1, in Australia, focusing on a miniature, ultra long-acting GLP-1 implant for obesity[2][4]. - Vivani plans to initiate the LIBERATE-1 study in Q4 2024, with data projected to be available in 2025[7]. - The GLP-1 implant demonstrated an 82% liver fat reduction in an obese mouse model from a single administration, with expected twice-yearly dosing[5]. - The company’s emerging pipeline includes the NPM-139 semaglutide implant, which has the potential for once-yearly administration[13]. Market Context - Medication non-adherence contributes to over $500 billion in annual avoidable healthcare costs in the U.S., highlighting the need for Vivani's innovative drug delivery solutions[13].