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, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ | Title of Each Class | Trading Symbol | Name of Each Exchange on Which Registered | | --- | --- | --- | | Common Stock, par value $0.0001 ...

Exhibit 10.1 SHARE PURCHASE AGREEMENT This Share Purchase Agreement (this "Agreement") is dated as of May 12, 2025 (the "Execution Date"), by and between Vivani Medical, Inc., a Delaware corporation (the "Company") and Gregg G Williams 2006 Irrevocable Trust (the "Purchaser"). The Company and the Purchaser are each hereafter referred to individually as a "Party" and together as the "Parties." RECITALS WHEREAS, subject to the terms and conditions set forth in this Agreement, the Company desires to issue and ...

All subjects in the NPM-115 cohort had successful insertions of a miniature, ultra long-acting GLP-1 (exenatide) implant in the on-going LIBERATE-1™ study in obese or overweight individuals; top-line results are anticipated in mid-2025 Announced new $3M equity financing together with the previously reported $8.25M equity financing secures financial position into mid-2026 Promising pre-clinical data released for NPM-139 (semaglutide implant) for chronic weight management in obese and overweight patients Comp ...

ALAMEDA, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ: VANI) (the “Company” or “Vivani”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, announced today that CEO Adam Mendelsohn, Ph.D., will present and participate in a panel discussion at the American Association of Pharmaceutical Scientists’ (AAPS) “Beyond GLP1s: Where the Science will Take Business Next” Virtual Workshop, taking place from May 13-14, 2025. Presentation details ar ...

Portfolio of miniature, once or twice-yearly GLP-1 implants in development for chronic weight management and type 2 diabetes Vivani CEO Adam Mendelsohn, Ph.D. and CMO Lisa Porter, M.D. to discuss the Company’s LIBERATE-1 clinical trial from which topline data is anticipated in mid-year 2025 ALAMEDA, Calif., April 16, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, today ...

Portfolio of miniature, once or twice-yearly GLP-1 implants in development for chronic weight management and type 2 diabetes Vivani CEO Adam Mendelsohn, Ph.D. and CMO Lisa Porter, M.D. to discuss the Company's LIBERATE-1 clinical trial from which topline data is anticipated in mid-year 2025 ALAMEDA, Calif., April 16, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ:VANI) ("Vivani" or the "Company"), a clinical-stage biopharmaceutical company developing miniature, ultra long- acting drug implants, today ...

ALAMEDA, Calif. and SAN FRANCISCO, April 15, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (NASDAQ:VANI) ("Vivani" or the "Company"), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, and Okava Pharmaceuticals, Inc. ("Okava"), a clinical-stage company focused on diseases of aging in dogs and cats, today announced an expansion of their collaboration to include dogs in the development of OKV-119, a long-acting GLP-1 therapy for weight management, diabetes and ot ...

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].

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].

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 ...