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].

or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 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 September 30, 2023 1350 S. Loop Road, Alameda, CA 94502 (Address of principal executive of ices, including zip code) (415) 506-8462 (Registrant's telephone number, including area code) Securities registere ...

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, 2023 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) (State or other jurisdiction ...

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, 2023 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) (State or other jurisdiction ...

Washington, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2022 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 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Vivani Medical, Inc. (Exact name of registrant as specified in its charter) California (State or other jurisdic ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☐ 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 Second Sight Medical Products, Inc. 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, 2022 OR (Exact name of Registrant as specified in its charter) (State or other ...