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].

Clinical Development - Vivani Medical anticipates the initiation of the NPM-115 clinical program in Q4 2024, focusing on a miniature, subdermal GLP-1 implant for obesity treatment[1]. - The FDA cleared the Investigational New Drug Application for NPM-119, enabling the transition to clinical-stage development for GLP-1 implants[1]. - The company plans to initiate the LIBERATE-1 study in Q4 2024, evaluating the GLP-1 implant in obese or overweight patients, with results expected in 2025[5]. - Vivani's pipeline includes NPM-139, a semaglutide implant for chronic weight management, which has the potential for once-yearly administration[9]. - Approximately 50% of chronic disease patients do not adhere to their medication as prescribed, highlighting the need for Vivani's long-acting GLP-1 implants[2]. Financial Performance - As of June 30, 2024, Vivani reported a cash balance of $26.3 million, down from $31.0 million as of March 31, 2024, reflecting a net loss of $5.4 million[7]. - The net loss for Q2 2024 was $5.3 million, an improvement from a net loss of $6.5 million in Q2 2023, attributed to a decrease in operating expenses[8]. - Net loss for Q2 2024 was $5,356,000, an improvement of 18% compared to a net loss of $6,526,000 in Q2 2023[13]. - Net loss per common share for Q2 2024 was $0.10, compared to $0.13 in Q2 2023, reflecting a reduction in loss per share[13]. - Net loss for the six months ended June 30, 2024, was $11,395,000, an improvement of 11.1% compared to $12,844,000 for the same period in 2023[13]. Expenses Management - Research and development expenses for Q2 2024 were $3.5 million, a decrease of 9% from $3.9 million in Q2 2023, primarily due to staffing reductions[7]. - General and administrative expenses decreased by 31% to $2.2 million in Q2 2024, down from $3.1 million in Q2 2023, also due to staffing reductions[8]. - Total operating expenses for Q2 2024 were $5,681,000, a decrease of 18.9% from $7,003,000 in Q2 2023[13]. - Total operating expenses for the six months ended June 30, 2024, were $11,908,000, down 12.5% from $13,604,000 for the same period in 2023[13]. - The company continues to focus on reducing operating expenses while managing research and development investments[13]. Asset Management - The total assets of Vivani as of June 30, 2024, were $48.2 million, an increase from $45.8 million as of December 31, 2023[12]. - Other income for Q2 2024 was $325,000, a decrease from $477,000 in Q2 2023[13]. - Weighted average common shares outstanding increased to 55,021,000 in Q2 2024 from 50,795,000 in Q2 2023[13].

Product Development - Vivani Medical, Inc. is focused on developing NPM-115, a miniature GLP-1 implant for chronic weight management, with a target of delivering therapeutic drug levels for up to six months [92]. - In a preclinical study, NPM-115 demonstrated a weight loss of approximately 20% in obese mice, comparable to semaglutide injections [99]. - The LIBERATE-1 study for NPM-115 is anticipated to begin in Q4 2024, pending regulatory clearance, with results expected in 2025 [104]. - An Investigational New Drug Application for NPM-119 was filed with the FDA on July 14, 2023, and the clinical hold was lifted on June 13, 2024 [97]. - Vivani established a wholly-owned subsidiary, Vivani Medical Australia Pty Ltd., to support studies of its product candidates [99]. Financial Performance - The company reported a net loss of $11.4 million for the first half of 2024, with cash used in operating activities amounting to $9.3 million [128]. - Cash, cash equivalents, and restricted cash increased by $4.3 million to $26.3 million as of June 30, 2024, with working capital rising to $20.6 million [128]. - Research and development expenses decreased by $0.4 million, or 9%, to $3.5 million for Q2 2024 compared to Q2 2023, primarily due to staffing reductions [117]. - General and administrative expenses decreased by $1.0 million, or 31%, to $2.2 million for Q2 2024 compared to Q2 2023, mainly due to staffing reductions and lower legal services [117]. - The company anticipates needing to raise additional capital to continue operations, with no assurance of favorable terms [110]. - The company has experienced recurring operating losses and negative cash flows since inception, with expectations to continue this trend for the foreseeable future [126]. Funding and Capital Strategy - 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 [105]. - The company raised gross proceeds of $15.0 million from a securities purchase agreement, resulting in net proceeds of $13.7 million after issuance costs [122]. - The company has entered into a sales agreement to offer up to $75.0 million in common stock, enhancing its capital funding strategy [106]. Market Need and Technology - Approximately 50% of patients do not adhere to their prescribed medication regimens, highlighting a significant market need for Vivani's drug delivery solutions [91]. - Vivani's NanoPortal™ technology allows for long-term, near constant-rate delivery of medications, minimizing fluctuations in drug levels [94]. - Cortigent, a subsidiary of Vivani, is advancing neurostimulation technology and has a funding support agreement with Vivani [95]. Grants and Funding Support - The company received a $1.6 million grant from the NIH to fund a clinical trial, with total grants offsetting operating expenses of $0.1 million in the first half of 2024, down from $0.3 million in 2023 [108]. Future Expectations - The company expects research and development expenses to increase in the future as it pursues product enhancements and new technology development [115]. - The company has not entered into foreign currency forward contracts to hedge operating expense exposure to foreign currencies but may consider doing so in the future [133].

Product Development - Vivani Medical's lead program NPM-115, a miniature GLP-1 implant for chronic weight management, is under further development with a focus on addressing medication non-adherence [110]. - In a preclinical study, NPM-115 demonstrated approximately 20% weight loss in high-fat diet-induced obese mice after 28 days, comparable to semaglutide injections [118]. - The company filed an Investigational New Drug Application for NPM-119 on July 14, 2023, but the study is currently on clinical hold due to insufficient Chemistry, Manufacturing, and Controls information [115]. - Vivani's NanoPortal technology allows for long-term, near constant-rate delivery of medications, aiming to improve medication adherence for chronic diseases [109]. Financial Performance - Vivani raised gross proceeds of $15.0 million from a registered direct offering of 3,947,368 shares at $3.80 per share on March 5, 2024 [121]. - The company has experienced recurring operating losses and negative cash flows since inception, relying on equity sales for funding [123]. - Vivani's current cash is estimated to meet planned obligations into the second half of 2025, but additional capital will be needed for continued operations [125]. - The company used $4.5 million in cash for operating activities in Q1 2024, compared to $7.0 million in Q1 2023 [140][141]. - Cash provided by financing activities was $13.7 million in Q1 2024, primarily from a securities purchase agreement [143]. - The company anticipates that available cash will meet its obligations into the second half of 2025, but future profitability remains uncertain [136]. Operational Updates - The company established Vivani Medical Australia Pty Ltd. to support studies of its product candidates in the fourth quarter of 2023 [117]. - Cortigent, a wholly owned subsidiary, is advancing Vivani's neurostimulation technology and is expected to repay $1.5 million to Vivani by the end of 2024 [116]. - The company has a total of 36 full-time employees and operates from its headquarters in Alameda, California [111]. Expenses - Research and development expenses for Q1 2024 were $3.7 million, a decrease of 6% from $4.0 million in Q1 2023, primarily due to reduced costs in the neurostimulation division [131]. - General and administrative expenses for Q1 2024 were $2.5 million, down 5% from $2.6 million in Q1 2023, mainly due to decreased costs in the neurostimulation division [132]. Cash Flow and Working Capital - Cash, cash equivalents, and restricted cash increased by $9.0 million from $22.0 million as of December 31, 2023, to $31.0 million as of March 31, 2024 [139]. - Working capital rose to $25.4 million as of March 31, 2024, an increase of $8.0 million from $17.3 million as of December 31, 2023 [139]. Future Outlook - The company expects research and development expenses to increase in the future as it pursues enhancements and develops new technologies [130]. - The company has not entered into foreign currency forward contracts to hedge operating expense exposure but may consider doing so in the future [148].

Financial Performance - As of March 31, 2024, Vivani Medical reported a cash balance of $31.0 million, an increase of $9.0 million from $22.0 million on December 31, 2023[8] - Research and development expenses for Q1 2024 were $3.7 million, a decrease of 6% from $4.0 million in Q1 2023[9] - General and administrative expenses for Q1 2024 were $2.5 million, down 5% from $2.6 million in Q1 2023[10] - The net loss for Q1 2024 was $6.0 million, a slight decrease from $6.3 million in Q1 2023[13] - Total assets increased to $53.8 million as of March 31, 2024, compared to $45.8 million on December 31, 2023[21] - The total stockholders' equity rose to $28.7 million as of March 31, 2024, up from $20.8 million at the end of 2023[21] Development Pipeline - Vivani plans to submit the IND application for NPM-115 in the second half of 2024 and initiate a first-in-human trial thereafter[12] - In February 2024, Vivani announced positive preclinical data for NPM-115, showing approximately 20% weight loss in obese mice after 28 days, comparable to semaglutide[4] - Vivani's pipeline includes NPM-115 and NPM-119, both designed for chronic weight management and type 2 diabetes, with a focus on improving medication adherence[16] Funding and Operations - The company completed a $15 million registered direct offering in March 2024 to accelerate development programs and fund operations into the second half of 2025[5]

Product Development - Vivani Medical's lead programs NPM-115 and NPM-119 are miniature, 6-month GLP-1 implant candidates targeting chronic weight management and type 2 diabetes, respectively [346]. - In February 2024, Vivani reported that NPM-115 achieved approximately 20% weight loss in a preclinical study, comparable to semaglutide injections [356]. - An Investigational New Drug Application for NPM-119 was filed with the FDA on July 14, 2023, but the study is currently on clinical hold due to insufficient CMC information [352]. - Vivani's NanoPortal technology allows for long-term, near constant-rate delivery of medications, aiming to improve adherence in chronic disease treatment [345]. - The company established Vivani Medical Australia Pty Ltd. to support studies of its products and candidates [355]. Financial Performance - Net loss increased by $11.8 million, from $13.9 million in 2022 to $25.7 million in 2023, attributed to higher operating expenses and the prior year's gain on the bargain purchase from the Second Sight acquisition [374]. - Cash, cash equivalents, and restricted cash decreased by $24.5 million, from $46.4 million in 2022 to $22.0 million in 2023 [378]. - Cash used in operating activities was $23.7 million in 2023, compared to $18.8 million in 2022, primarily due to a net loss of $25.7 million [379][381]. - Other income decreased significantly from $7.4 million in 2022 to $1.3 million in 2023, primarily due to the absence of a gain on bargain purchase from the Second Sight acquisition [373]. Funding and Capital Management - Vivani raised approximately $15.0 million through a registered direct offering of 3,947,368 shares at $3.80 per share on March 5, 2024 [362]. - The company has received a $1.6 million grant from the NIH, with a total potential funding of $6.4 million over five years, to support a clinical trial [360]. - The company entered into a Securities Purchase Agreement on March 1, 2024, for the issuance of 3,947,368 shares at a purchase price of $3.80 per share, generating gross proceeds of approximately $15.0 million [376]. - The company estimates that current cash will meet planned obligations into the second half of 2025, contingent on developing profitable operations or raising additional capital [377]. Operational Changes - As of December 31, 2023, Cortigent, a wholly-owned subsidiary, had 5,000,000 shares of common stock outstanding after a 1-for-4 reverse stock split [349]. - The company has reduced Cortigent's workforce from 14 to 7 employees to conserve cash while continuing clinical studies [354]. - Working capital decreased from $40.7 million in 2022 to $17.3 million in 2023 [378]. - The company has experienced recurring operating losses and negative operating cash flows since inception, relying on equity securities sales for working capital [375]. Expense Management - Research and development expenses increased by $2.8 million, or 20%, from $14.2 million in 2022 to $17.0 million in 2023, primarily due to higher payroll and the inclusion of the neuromodulation division from the Second Sight acquisition [371]. - General and administrative expenses rose by $2.9 million, or 41%, from $7.1 million in 2022 to $10.0 million in 2023, driven by increased payroll, rent, and the inclusion of the neuromodulation division [372].

Financial Performance - Vivani Medical reported a net loss of $25.7 million for the full year 2023, an increase of 85% compared to a net loss of $13.9 million in 2022[17]. - The net loss for the twelve months ended December 31, 2023, was $25,652,000, an increase of 84.8% from $13,889,000 in 2022[25]. - The net loss for Q4 2023 was $6,026,000, compared to a net loss of $7,284,000 in Q4 2022, representing a 17.3% improvement[25]. - The net loss per common share for Q4 2023 was $0.12, compared to $0.14 in Q4 2022[25]. - The company reported a loss from operations of $6,217,000 for Q4 2023, compared to a loss of $7,790,000 in Q4 2022[25]. Research and Development - Research and development expenses for the fourth quarter of 2023 were $4.7 million, a 6% increase from $4.4 million in the same quarter of 2022[9]. - Research and development expenses for the full year 2023 totaled $17.0 million, a 20% increase from $14.2 million in 2022[14]. - NPM-115 demonstrated approximately 20% weight loss in preclinical studies, comparable to semaglutide, after a 28-day treatment in obese mice[5]. - The company plans to submit a new Investigational New Drug Application for NPM-115 later in 2024, aiming to initiate a first-in-human trial after receiving regulatory clearance[11]. Expenses - General and administrative expenses decreased by 55% to $1.5 million in Q4 2023, down from $3.4 million in Q4 2022[10]. - General and administrative expenses for Q4 2023 were $1,509,000, a decrease of 55.2% from $3,363,000 in Q4 2022[25]. - Total operating expenses for Q4 2023 were $6,217,000, a decrease of 20.2% from $7,790,000 in Q4 2022[25]. - Total operating expenses for the twelve months ended December 31, 2023, were $26,965,000, an increase of 27.2% from $21,241,000 in 2022[25]. Financial Position - As of December 31, 2023, Vivani had cash and cash equivalents totaling $20.7 million, down from $45.1 million at the end of 2022[23]. - Total liabilities as of December 31, 2023, were $25.0 million, compared to $6.8 million at the end of 2022[23]. Corporate Developments - The company appointed Daniel Bradbury to its Board of Directors, who previously led the approval of Bydureon, a significant GLP-1 receptor agonist[4]. - The company raised $15 million in a financing round in March 2024 to accelerate development programs and fund operations into the second half of 2025[3]. Other Income - Other income for Q4 2023 was $191,000, a decrease of 62.3% from $506,000 in Q4 2022[25]. Share Information - The weighted average shares outstanding for the twelve months ended December 31, 2023, were 50,853,000, compared to 38,241,000 in 2022[25].

Financial Performance - General and administrative expenses rose by $1.1 million, or 71%, to $2.7 million in Q3 2023 from $1.6 million in Q3 2022, driven by increased costs from the acquisition and higher public company expenses [121]. - General and administrative expenses surged by $4.8 million, or 129%, to $8.5 million in the first nine months of 2023 from $3.7 million in the same period of 2022, reflecting higher costs from the acquisition and public company operations [124]. - Other income increased to $1.1 million for the nine months ended September 30, 2023, compared to $6.9 million for the same period in 2022 due to the merger acquisition [125]. - Cash, cash equivalents, and restricted cash decreased by $20.2 million from $46.4 million as of December 31, 2022, to $26.2 million as of September 30, 2023 [132]. - Operating activities used $20.2 million in cash during the nine months ended September 30, 2023, primarily due to a net loss of $19.6 million [133]. - Financing activities generated $110,000 in the nine months ended September 30, 2023, compared to $63.4 million in the same period of 2022 [135]. Research and Development - Research and development expenses increased by $0.5 million, or 15%, to $4.4 million in Q3 2023 from $3.9 million in Q3 2022, primarily due to costs associated with the acquired company Second Sight [120]. - For the first nine months of 2023, research and development expenses increased by $2.6 million, or 26%, to $12.3 million from $9.7 million in the same period of 2022, largely due to the inclusion of Second Sight's costs [123]. - The company intends to utilize research and development incentives from the Australian government to support clinical trials while seeking to lift the clinical hold with the FDA [105]. - The company expects expenses to increase as it initiates clinical trials and seeks marketing approval for product candidates, particularly for NPM-119 [130]. Clinical Trials and Regulatory Matters - An Investigational New Drug Application for NPM-119 was filed with the FDA on July 14, 2023, but the study is currently on full clinical hold due to insufficient Chemistry, Manufacturing, and Controls information [105][112]. - The company received a $6.4 million NIH grant for a clinical trial, with the final year grant of $1.0 million approved in March 2023 [110]. Company Strategy and Future Outlook - The company plans to focus exclusively on the drug implant business, subject to the completion of Cortigent's initial public offering [102]. - The company is subject to risks associated with having no revenue while developing novel pharmaceutical products and medical devices, expecting to incur operating losses and negative cash flows for the foreseeable future [111]. - The company has incurred recurring operating losses and negative operating cash flows since inception, with expectations to continue this trend for the foreseeable future [128]. - The company anticipates seeking funding through public or private equity or debt financings, grants, collaborations, or strategic partnerships [131]. - As of September 30, 2023, the company did not have any off-balance sheet arrangements [136]. Cash Position - The company reported $53.3 million in net assets, including approximately $55.4 million in cash, following the reverse merger with Second Sight [109]. - Cash balance as of September 30, 2023, was $24.8 million, excluding $3.2 million of reimbursable tenant improvements, with a cash runway expected to extend into early 2025 [128].