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 ...

Washington, DC 20549 UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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, 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 Vivani Medical, Inc. (Exact name of Registrant as specified in its charter) (State or other jurisdict ...

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 ...

(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, 2022 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 For the transition period from ________ to ________ (818) 833-5000 Commission File Number 001-36747 Second Sight Medical Products, Inc. (Exact name of Registrant as specified in its charter) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION 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, 2021 (State or other jurisdiction of incorporation or organization) 02-0692322 (I.R.S. Employer Identification No.) 13170 Telfair Avenue, Sylmar, CA 91342 (Address of principal executive of ices, including zip code) OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHAN ...