Core Viewpoint - Vivani Medical, Inc. has announced a temporary withdrawal of the previously set record date for the spin-off of its subsidiary Cortigent, due to delays caused by the U.S. federal government shutdown [1][2]. Group 1: Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing miniature, ultra long-acting drug implants [1]. - The company utilizes its proprietary NanoPortal™ platform to create biopharmaceutical implants aimed at delivering drug molecules steadily over extended periods, enhancing patient adherence and tolerance [3]. - Vivani is developing a portfolio of GLP-1 based implants targeting metabolic diseases such as obesity and type 2 diabetes [3]. Group 2: Cortigent Overview - Cortigent, a wholly-owned subsidiary of Vivani, is focused on developing brain implant devices that utilize advanced neuromodulation technology to aid patients in recovering critical body functions [2]. - The Orion Visual Cortical Prosthesis System, an investigational system by Cortigent, is designed to treat blindness from common conditions like glaucoma and diabetic retinopathy, and has received FDA Breakthrough Device designation [2]. - Cortigent's technology also aims to improve recovery of arm and hand motion in patients with paralysis due to stroke [2]. Group 3: Financial Advisory - ThinkEquity is serving as the exclusive financial advisor to Cortigent regarding the spin-off transaction [2].

Summary of Vivani Medical Conference Call Company Overview - **Company**: Vivani Medical Inc. (NasdaqCM: VANI) - **Focus**: Development of biopharmaceutical implants using the proprietary NanoPortal platform to deliver drug molecules steadily over extended periods, aiming to improve medication adherence and tolerability [2][3] Industry Insights - **Market Context**: The company is addressing the significant issue of medication non-adherence, with over 50% of patients not taking their medications as prescribed [3][27] - **GLP-1 Market**: The GLP-1 medicines have transformed obesity and diabetes treatment, with three FDA-approved injectable drugs currently available and expectations for oral versions in the future [5][6] - **Revenue Potential**: GLP-1 products generated over $14 billion in sales in 2024, with a projected 32% compound annual growth rate until the early 2030s [26] Core Technology and Product Development - **Implant Technology**: Vivani Medical is developing a unique implant that allows for long-lasting treatment with a single administration, addressing the challenges of poor medication adherence and tolerability associated with existing GLP-1 therapies [7][8][15] - **Lead Program**: The lead program focuses on a semaglutide implant, which has shown promising results in preclinical studies, including a 20% weight loss over seven months [16][30] - **Clinical Studies**: A successful first-in-human study was completed, demonstrating positive safety and tolerability, with plans to initiate further clinical development in the first half of next year [24][32] Key Challenges and Solutions - **Medication Adherence**: The implant aims to provide guaranteed adherence, eliminating missed doses and improving real-world outcomes [12][14] - **Tolerability Issues**: The technology seeks to mitigate gastrointestinal side effects commonly associated with GLP-1 medications by providing stable drug delivery [12][14] - **Cost-Effectiveness**: The implant is expected to reduce costs associated with existing injectable therapies, potentially increasing access and pricing flexibility [15] Future Applications and Market Expansion - **Broader Indications**: Beyond obesity, the semaglutide implant is being evaluated for type 2 diabetes, chronic kidney disease, and potentially Alzheimer's disease and alcohol addiction [27][30] - **Market Reception**: Patient surveys indicate a high likelihood of acceptance for a GLP-1 implant, with a comparison made to the successful contraceptive implant Nexplanon, which generated approximately $1 billion in sales [31] Leadership and Operations - **Experienced Team**: The company boasts a seasoned leadership team with extensive experience in drug-device combination products and clinical development [34] - **Manufacturing Capabilities**: Vivani Medical has a facility in Alameda, California, for GMP manufacturing to support early commercial production [35] Additional Notes - **Spin-off Announcement**: The company plans to spin off a subsidiary, Cortigent, which focuses on brain implant devices, offering shareholders a dividend of shares in this new entity [36] This summary encapsulates the key points discussed during the Vivani Medical conference call, highlighting the company's innovative approach to addressing medication adherence in chronic disease management through its unique implant technology.

ALAMEDA, Calif., Sept. 24, 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 announced that it will present at the Emerging Growth Conference 86 on September 25, 2025. Vivani welcomes individual and institutional investors, along with advisors and analysts, to join its interactive presentation. This live online event will offer existing shareholders and the investme ...

Core Insights - Vivani Medical, Inc. is spinning off its wholly-owned subsidiary Cortigent, which specializes in brain implant devices utilizing precision neurostimulation technology [1][3] - Cortigent has completed a 6-year Early Feasibility Study for its Orion® artificial vision system aimed at treating blindness [1][3] - The spin-off is expected to enhance strategic and operational flexibility for both Vivani and Cortigent, allowing each to focus on their respective business strategies [3][5] Company Overview - Cortigent is the only company with FDA approval for a device providing artificial vision for the profoundly blind [1] - The Orion® Visual Cortical Prosthesis System is designed to treat blindness from common conditions like glaucoma and diabetic retinopathy, and has received FDA Breakthrough Device designation [7] - Cortigent is also developing a medical device to improve arm and hand motion recovery in stroke patients [1][7] Spin-off Details - The record date for Vivani shareholders to receive common stock in Cortigent is set for October 8, 2025 [2] - Cortigent is expected to trade on the Nasdaq under the ticker symbol "CRGT" [2] - The spin-off is anticipated to be completed by late 2025, subject to regulatory approvals and other conditions [5] Management and Future Plans - Jonathan Adams, MBA, will continue as CEO of Cortigent post-spin-off [4] - The spin-off aims to position Cortigent among a select group of public companies focused on neuromodulation and brain-computer interface technologies [3][4] - Cortigent plans to advance its Orion pivotal clinical trial to seek FDA approval and conduct an Early Feasibility Study for its Stroke Recovery System [3]

Core Viewpoint - Vivani Medical, Inc. is advancing its NPM-139 semaglutide implant program, aiming for Wegovy-level efficacy with less frequent administration, and plans to initiate a Phase 1 clinical study in the first half of 2026, pending regulatory clearance [1][2][3] Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing ultra long-acting drug implants using its proprietary NanoPortal™ technology [5] - The company is developing a portfolio of GLP-1 based implants targeting chronic weight management and other metabolic diseases, including type 2 diabetes [5] Clinical Development Plans - The Phase 1 study of NPM-139 will assess safety, tolerability, and pharmacokinetics in obese or overweight subjects, with a control arm of low-dose Wegovy injections [3][4] - A Phase 2 study is planned to follow the Phase 1 study, pending results, to evaluate the effects of the semaglutide implant on weight management over 4 to 6 months [4] Market Potential - The GLP-1 market for weight management is experiencing significant growth due to unmet medical needs and improved safety and efficacy profiles of current GLP-1 options compared to previous obesity treatments [2] - NPM-139 is expected to differentiate itself by offering a convenient administration schedule of once or twice a year, potentially improving patient adherence and tolerability [2][6]

Core Viewpoint - Vivani Medical, Inc. is preparing to present its innovative drug implant technology at the H.C. Wainwright 27th Annual Global Investment Conference, focusing on improving medication adherence and patient outcomes in chronic disease management [1][3]. Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company specializing in miniature, ultra long-acting drug implants [1][3]. - The company utilizes its proprietary NanoPortal™ technology to develop biopharmaceutical implants that deliver drug molecules steadily over extended periods [3]. - Medication non-adherence affects approximately 50% of patients, highlighting the need for innovative solutions [3]. Product Pipeline - The priority product candidate is NPM-139, a miniature, six-month, subdermal GLP-1 (semaglutide) implant aimed at chronic weight management in obese or overweight individuals [3]. - NPM-139 has the potential for once-yearly dosing, which could significantly enhance patient compliance [3]. - Other products in development include NPM-115 (exenatide implant) for chronic weight management and NPM-119 (exenatide implant) for type-2 diabetes treatment [3]. Upcoming Presentation Details - CEO Adam Mendelsohn will present on September 10, 2025, at the Lotte New York Palace Hotel, focusing on the company's innovative drug implant technology [1]. - The presentation is part of the H.C. Wainwright 27th Annual Global Investment Conference, which runs from September 8-10, 2025 [1].

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section presents Vivani Medical, Inc.'s unaudited condensed consolidated financial statements and related disclosures [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents Vivani Medical, Inc.'s unaudited condensed consolidated financial statements and detailed notes for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024) This section presents Vivani Medical, Inc.'s condensed consolidated balance sheets, detailing assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 **Condensed Consolidated Balance Sheet Highlights (in thousands):** | Metric | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $6,794 | $18,352 | | Total current assets | $8,715 | $20,442 | | Total assets | $28,905 | $41,561 | | Total current liabilities | $6,716 | $5,986 | | Total liabilities | $23,995 | $23,951 | | Total stockholders' equity | $4,910 | $17,610 | [Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2025 and 2024](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) This section presents Vivani Medical, Inc.'s condensed consolidated statements of operations, detailing revenues, expenses, and net loss for the specified periods **Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data):** | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development, net of grants | $4,759 | $3,513 | $8,976 | $7,239 | | General and administrative, net of grants | $2,703 | $2,168 | $5,044 | $4,669 | | Total operating expenses | $7,462 | $5,681 | $14,020 | $11,908 | | Net loss | $(7,144) | $(5,356) | $(13,446) | $(11,395) | | Net loss per common share - basic and diluted | $(0.12) | $(0.10) | $(0.23) | $(0.21) | [Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2025 and 2024](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) This section presents Vivani Medical, Inc.'s condensed consolidated statements of comprehensive loss, including net loss and other comprehensive income items **Condensed Consolidated Statements of Comprehensive Loss Highlights (in thousands):** | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(7,144) | $(5,356) | $(13,446) | $(11,395) | | Foreign currency translation adjustments | $39 | $(25) | $33 | $(77) | | Comprehensive loss | $(7,105) | $(5,381) | $(13,413) | $(11,472) | [Condensed Consolidated Statements of Stockholders' Equity for each three month period ended during the six months ended June 30, 2025 and 2024](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20for%20each%20three%20month%20period%20ended%20during%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) This section presents Vivani Medical, Inc.'s condensed consolidated statements of stockholders' equity, detailing changes in equity components for the specified periods **Condensed Consolidated Statements of Stockholders' Equity Highlights (in thousands):** | Metric | Balance, January 1, 2025 ($) | Balance, June 30, 2025 ($) | | :-------------------------- | :----------------------- | :--------------------- | | Common Stock (Amount) | $6 | $6 | | Additional Paid-in Capital | $139,480 | $140,193 | | Accumulated Other Comprehensive Income | $48 | $81 | | Accumulated Deficit | $(121,924) | $(135,370) | | Total Stockholders' Equity | $17,610 | $4,910 | [Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2025 and 2024](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) This section presents Vivani Medical, Inc.'s condensed consolidated statements of cash flows, detailing cash movements from operating, investing, and financing activities **Condensed Consolidated Statements of Cash Flows Highlights (in thousands):** | Metric | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(11,250) | $(9,313) | | Net cash used in investing activities | $(76) | $(219) | | Net cash (used in) provided by financing activities | $(265) | $13,799 | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(11,558) | $4,265 | | Cash, cash equivalents and restricted cash balance at end of period | $8,132 | $26,257 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the condensed consolidated financial statements, covering accounting policies, equity, debt, and contingencies [Note 1. Organization and Business Operations](index=8&type=section&id=Note%201.%20Organization%20and%20Business%20Operations) This note describes Vivani Medical, Inc.'s core business, product pipeline, and recent corporate developments, including the Cortigent spin-off - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company developing miniature, ultra long-acting subdermal drug implants using its proprietary NanoPortal™ technology to treat chronic diseases by improving medication adherence and tolerability[23](index=23&type=chunk)[24](index=24&type=chunk) - The company's lead program, NPM-139 (semaglutide implant), is in development for chronic weight management, showing encouraging preclinical data with approximately **20% maintained weight loss over six months** and potential for annual dosing[25](index=25&type=chunk)[40](index=40&type=chunk) - Other programs include NPM-115 (high-dose exenatide implant) for chronic weight management, NPM-119 (exenatide implant) for type 2 diabetes, and OKV-119 (GLP-1 based implant) for animal health in collaboration with Okava Pharmaceuticals, Inc[25](index=25&type=chunk) - The FDA cleared the Investigational New Drug (IND) application and lifted the clinical hold for NPM-119 on **June 13, 2024**[35](index=35&type=chunk) - The LIBERATE-1 clinical trial for NPM-115 (exenatide implant) in obese and overweight individuals was initiated in Australia at the end of 2024, with the first implant successfully administered on **March 13, 2025**, and top-line results anticipated in mid-2025[37](index=37&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk) - Vivani announced plans on **August 5, 2025**, to prioritize the advancement of NPM-139, with clinical development expected to begin in 2026, based on positive LIBERATE-1 data and new NPM-139 preclinical feasibility data[40](index=40&type=chunk) - Cortigent, Inc., a wholly-owned subsidiary focused on neurostimulation, filed a Form 10 registration statement on **May 29, 2025**, to spin off as an independent, publicly traded company, with completion planned for Q3 or Q4 2025[41](index=41&type=chunk)[43](index=43&type=chunk) [Note 2. Basis of Presentation and Significant Accounting Policies](index=11&type=section&id=Note%202.%20Basis%20of%20Presentation%20and%20Significant%20Accounting%20Policies) This note outlines the basis of financial statement preparation, significant accounting policies, and segment reporting - The unaudited interim financial statements are prepared in accordance with GAAP and SEC requirements for interim reporting, consolidating the accounts of the Company and its wholly owned subsidiaries[48](index=48&type=chunk)[49](index=49&type=chunk) - The Company has two non-revenue-producing operating segments: the Biopharm Division and the Neurostimulation Division[50](index=50&type=chunk) - Recently issued accounting pronouncements, ASU 2024-03 and ASU 2023-09, are not expected to have a material effect on the consolidated financial statements, though additional disclosures will be required upon adoption[53](index=53&type=chunk)[54](index=54&type=chunk) [Note 3. Concentration of Risk](index=12&type=section&id=Note%203.%20Concentration%20of%20Risk) This note discusses the company's exposure to credit risk from financial instruments and risks associated with foreign operations - Financial instruments are primarily exposed to credit risk through cash, certificates of deposit, and money market funds maintained with reputable financial institutions[55](index=55&type=chunk) - Foreign operations in Switzerland and Australia carry inherent risks, with assets amounting to approximately **$24,000** and **$642,000**, respectively, as of June 30, 2025[56](index=56&type=chunk) [Note 4. Fair Value Measurements](index=13&type=section&id=Note%204.%20Fair%20Value%20Measurements) This note explains the fair value hierarchy used for financial instruments and details the valuation of cash equivalents - The company uses a three-level fair value hierarchy for financial instruments, with Level 1 inputs for quoted prices in active markets, Level 2 for observable inputs, and Level 3 for unobservable inputs[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk)[60](index=60&type=chunk) - Cash equivalents (certificates of deposit and money market funds) are the only financial instruments measured at fair value on a recurring basis and are classified as **Level 1 inputs**[62](index=62&type=chunk) **Fair Value of Cash Equivalents (in thousands):** | Asset Category | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------- | :------------ | :---------------- | | Certificates of deposit | $3,000 | $9,996 | | Money market funds | $2,812 | $7,441 | | **Total** | **$5,812** | **$17,437** | [Note 5. Insurance Premium Financing](index=13&type=section&id=Note%205.%20Insurance%20Premium%20Financing) This note details the company's insurance premium financing agreement, including its repayment status - The company entered a finance agreement in **September 2024** for approximately **$426,000** to fund insurance premiums, incurring **7.2% interest**[64](index=64&type=chunk) - The loan was fully repaid, with no outstanding balance as of **June 30, 2025**[64](index=64&type=chunk) [Note 6. Selected Balance Sheet Detail](index=14&type=section&id=Note%206.%20Selected%20Balance%20Sheet%20Detail) This note provides a detailed breakdown of selected balance sheet items, specifically property and equipment, net **Property and Equipment, Net (in thousands):** | Category | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------- | :------------ | :---------------- | | Total property and equipment at cost | $4,422 | $4,334 | | Accumulated depreciation and amortization | $(2,845) | $(2,641) | | **Property and equipment, net** | **$1,577** | **$1,693** | [Note 7. Equity Securities](index=14&type=section&id=Note%207.%20Equity%20Securities) This note details the company's common stock, registered direct offerings, and private sale transactions - As of **June 30, 2025**, the company had **300,000,000** authorized common shares with **59,243,903** shares issued and outstanding, and no preferred stock outstanding[66](index=66&type=chunk) - In **March 2024**, the company completed a registered direct offering, issuing **3,947,368** common shares and warrants for **$3.80 per share**, generating **$13.7 million** in net proceeds[67](index=67&type=chunk) - An Open Market Sale Agreement with Jefferies LLC allows the company to sell up to **$75.0 million** in common stock; during the six months ended June 30, 2025, **9,215** shares were issued for **$10,000** gross proceeds, resulting in negative net proceeds of **$28,000** after expenses[68](index=68&type=chunk)[71](index=71&type=chunk) - Private sale transactions include **$5.0 million** gross proceeds from a **November 2024** sale, and agreements for approximately **$8.25 million** (**March 2025**) and **$3.0 million** (**May 2025**) in gross proceeds from affiliated entities[72](index=72&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk) [Note 8. Warrants](index=15&type=section&id=Note%208.%20Warrants) This note provides information on warrant activity, including outstanding warrants, exercise prices, and contractual lives **Warrant Activity (in thousands, except per share and contractual life data):** | Metric | As of December 31, 2024 | As of June 30, 2025 | | :-------------------------------- | :---------------------- | :-------------------- | | Warrants outstanding (shares) | 9,340 | 8,248 | | Weighted Average Exercise Price Per Share ($) | $3.42 | $3.46 | | Weighted Average Remaining Contractual Life (in Years) | 1.6 | 1.3 | | Forfeited or expired (shares) | - | (1,092) | | Warrants exercisable (shares) | 9,340 | 8,248 | - Warrants outstanding as of **June 30, 2025**, had no intrinsic value[78](index=78&type=chunk) [Note 9. Stock-Based Compensation](index=16&type=section&id=Note%209.%20Stock-Based%20Compensation) This note details stock option and RSU activity, along with the total stock-based compensation expense recognized - As of **June 30, 2025**, **275,401** shares of common stock were available for future issuance under the Vivani Medical, Inc. 2022 Omnibus Incentive Plan[79](index=79&type=chunk) **Stock Option Activity (in thousands, except per share and contractual life data):** | Metric | As of December 31, 2024 | As of June 30, 2025 | | :-------------------------------- | :---------------------- | :-------------------- | | Options outstanding (shares) | 6,809 | 8,407 | | Weighted Average Exercise Price Per Share ($) | $2.52 | $2.25 | | Weighted Average Remaining Contractual Life (in Years) | 6.55 | 6.79 | | Granted (shares) | - | 1,617 | | Options exercisable (shares) | 5,454 | 5,454 | **Restricted Stock Units (RSUs) Activity (in thousands, except per share data):** | Metric | As of December 31, 2024 | As of June 30, 2025 | | :-------------------------------- | :---------------------- | :-------------------- | | Outstanding (shares) | 695 | 988 | | Weighted Average Grant Date Fair Value Per Share ($) | $1.25 | $1.14 | | Granted (shares) | - | 293 | **Total Stock-Based Compensation Expense (in thousands):** | Period | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $215 | $248 | $411 | $483 | | General and administrative | $176 | $135 | $330 | $253 | | **Total stock-based compensation expense** | **$391** | **$383** | **$741** | **$736** | - As of **June 30, 2025**, total unrecognized stock-based compensation expense was **$2.7 million** for stock options (weighted average period of **1.5 years**) and **$0.4 million** for RSUs (weighted average period of **1.5 years**)[84](index=84&type=chunk) [Note 10. Net Loss Per Share](index=19&type=section&id=Note%2010.%20Net%20Loss%20Per%20Share) This note presents the calculation of basic and diluted net loss per common share and lists excluded common stock equivalents **Net Loss Per Common Share (in thousands, except per share amounts):** | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(7,144) | $(5,356) | $(13,446) | $(11,395) | | Weighted average common shares outstanding - basic and diluted | 59,244 | 55,021 | 59,240 | 53,612 | | **Net loss per common share, basic and diluted** | **$(0.12)** | **$(0.10)** | **$(0.23)** | **$(0.21)** | - Basic and diluted net loss per share are the same for all periods presented because the company was in a loss position, making all potential common stock equivalents anti-dilutive[95](index=95&type=chunk) **Common Stock Equivalents Excluded from Diluted Net Loss Per Share (in thousands):** | Category | June 30, 2025 (shares) | June 30, 2024 (shares) | | :-------------------------------- | :------------ | :------------ | | Stock options issued and outstanding | 8,407 | 6,616 | | Unvested restricted stock units issued and outstanding | 988 | 695 | | Warrants to purchase common stock | 8,248 | 10,484 | | **Total** | **17,643** | **17,795** | [Note 11. Right-of-use Assets and Operating Lease Liabilities](index=19&type=section&id=Note%2011.%20Right-of-use%20Assets%20and%20Operating%20Lease%20Liabilities) This note details the company's operating lease arrangements, including right-of-use assets and lease liabilities - The company leases office, laboratory, and R&D space, including a significant triple net lease in Alameda, California, with a term ending **September 30, 2033**[98](index=98&type=chunk)[99](index=99&type=chunk) **Operating Lease Information (in thousands):** | Metric | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------------- | :------------ | :---------------- | | Right-of-use assets, non-current | $17,146 | $17,957 | | Current operating lease liabilities | $1,337 | $1,348 | | Long-term operating lease liabilities | $17,279 | $17,965 | | Total lease liabilities (June 30, 2025) | $18,616 | N/A | | Weighted average remaining lease term (June 30, 2025) | 8.25 years | N/A | | Weighted average discount rate (June 30, 2025) | 8.38% | N/A | **Operating Lease Costs (in thousands):** | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Operating lease cost | $800 | $800 | $1,600 | $1,700 | | Variable lease cost | $200 | $100 | $400 | $200 | [Note 12. Commitments and Contingencies](index=21&type=section&id=Note%2012.%20Commitments%20and%20Contingencies) This note outlines the company's legal proceedings and potential financial obligations arising from various commitments and contingencies - An opposition filed by Pixium Vision SA challenging a European patent owned by Cortigent was abandoned in **February 2025**, with no material effect expected on Cortigent's operations[105](index=105&type=chunk) - The company is appealing a Paris Commercial Court judgment ordering it to pay Pixium Vision SA approximately **€1.55 million (net)** related to a terminated MOU; Vivani's appeal was struck out on **October 23, 2024**, for failure to enforce the decision[106](index=106&type=chunk)[107](index=107&type=chunk) - Oppenheimer & Co. Inc. filed a breach of contract claim seeking at least **$1.625 million**; the court dismissed all claims except for breach of contract, and both the company and Oppenheimer have filed notices of appeal[108](index=108&type=chunk) [Note 13. Segment Information](index=22&type=section&id=Note%2013.%20Segment%20Information) This note provides financial information for the company's two non-revenue-producing operating segments: Biopharm and Neurostimulation - The company operates in two non-revenue-producing segments: the Biopharm Division (primary focus) and the Neurostimulation Division (planned spin-off)[110](index=110&type=chunk)[111](index=111&type=chunk) **Segment Operating Expenses and Net Loss (in thousands):** | Metric | Biopharm Division (3M Ended June 30, 2025) ($) | Neurostimulation Division (3M Ended June 30, 2025) ($) | Biopharm Division (6M Ended June 30, 2025) ($) | Neurostimulation Division (6M Ended June 30, 2025) ($) | | :-------------------------- | :--------------------------------------- | :--------------------------------------------- | :--------------------------------------- | :--------------------------------------------- | | Operating expenses | $6,700 | $700 | $12,700 | $1,300 | | Segment net loss | $6,366 | $778 | $12,011 | $1,435 | **Segment Total Assets (in thousands):** | Metric | As of June 30, 2025 ($) | | :-------------------------- | :------------------ | | Biopharm Division | $28,200 | | Neurostimulation Division | $700 | [Note 14. Subsequent Event](index=23&type=section&id=Note%2014.%20Subsequent%20Event) This note discloses significant events occurring after the reporting period, including new legislation and a share purchase agreement - The One Big Beautiful Bill Act (OBBBA) was signed into law on **July 4, 2025**, permanently eliminating the requirement to capitalize and amortize U.S. R&D expenditures and returning interest limitation rules to tax basis EBITDA[116](index=116&type=chunk) - On **August 11, 2025**, the company entered into a share purchase agreement to sell **7,936,507** common shares for approximately **$10.0 million** in gross proceeds[117](index=117&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Vivani Medical's financial condition, liquidity, capital resources, and operational results [Business Overview](index=24&type=section&id=Business%20Overview) This section provides an overview of Vivani Medical, Inc.'s biopharmaceutical focus, product pipeline, and corporate developments - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing miniature, ultra long-acting subdermal drug implants using its NanoPortal™ technology to address medication non-adherence and improve drug tolerability for chronic diseases[119](index=119&type=chunk)[120](index=120&type=chunk) - The company's priority program, NPM-139 (semaglutide implant), is in development for chronic weight management, with preclinical data showing approximately **20% weight loss maintained for over six months** and potential for annual dosing; clinical development is expected to begin in **2026**[121](index=121&type=chunk)[135](index=135&type=chunk) - The LIBERATE-1 clinical trial for NPM-115 (exenatide implant) in obese and overweight patients was initiated in Australia, with the first implant administered on **March 13, 2025**, and top-line results anticipated in mid-2025[132](index=132&type=chunk)[134](index=134&type=chunk) - Cortigent, Inc., the neurostimulation subsidiary, filed a Form 10 registration statement on **May 29, 2025**, to spin off as an independent, publicly traded company, with the spin-off planned for **Q3 or Q4 2025**[136](index=136&type=chunk)[138](index=138&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, working capital, and ongoing need for substantial additional funding - The company has experienced recurring operating losses and negative operating cash flows since inception and expects to continue incurring them for the foreseeable future[145](index=145&type=chunk) - Equity purchase agreements in **March, May, and August 2025** are expected to provide an additional **$21.25 million** in committed capital from **September 2025 through July 2026**[46](index=46&type=chunk) - Currently available cash is estimated to provide sufficient funds to meet planned obligations for at least the next **twelve months**[146](index=146&type=chunk) **Liquidity Metrics (in millions):** | Metric | June 30, 2025 ($) | December 31, 2024 ($) | | :----------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and restricted cash | $8.1 | $19.7 | | Working capital | $2.0 | $14.5 | | Decrease in cash, cash equivalents and restricted cash | $(11.6) | N/A | | Decrease in working capital | $(12.5) | N/A | - The company will require substantial additional funding to pursue its business objectives and commercialize products, with no assurance of obtaining it on favorable terms or at all[147](index=147&type=chunk)[149](index=149&type=chunk) [Critical Accounting Policies and Estimates](index=29&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section outlines the key accounting policies and estimates that require significant management judgment - Financial statement preparation requires management estimates and assumptions, particularly for accruals, equity instrument valuation, stock-based compensation, and going concern assessment[151](index=151&type=chunk) - No material changes to critical accounting policies were reported during the three months ended **June 30, 2025**, compared to the Form 10-K for **December 31, 2024**[152](index=152&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) This section analyzes the company's operating expenses and cash flow activities for the reported periods **Operating Expenses Comparison (in millions):** | Expense Category | 3 Months Ended June 30, 2025 ($) | 3 Months Ended June 30, 2024 ($) | Change ($) | Change (%) | | :----------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and development | $4.8 | $3.5 | $1.3 | 35% | | General and administrative | $2.7 | $2.2 | $0.5 | 25% | | | | | | | | Expense Category | 6 Months Ended June 30, 2025 ($) | 6 Months Ended June 30, 2024 ($) | Change ($) | Change (%) | | :----------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and development | $9.0 | $7.2 | $1.8 | 24% | | General and administrative | $5.0 | $4.7 | $0.3 | 8% | **Cash Flow Activities (in millions):** | Activity | 6 Months Ended June 30, 2025 ($) | 6 Months Ended June 30, 2024 ($) | | :-------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(11.3) | $(9.3) | | Net cash used in investing activities | $(0.1) | $(0.2) | | Net cash (used in) provided by financing activities | $(0.3) | $13.8 | [Off-Balance Sheet Arrangements](index=30&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of any off-balance sheet arrangements as of June 30, 2025 - As of **June 30, 2025**, the company did not have any off-balance sheet arrangements[164](index=164&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section outlines the company's exposure to market risks, primarily focusing on interest rate and foreign exchange rate sensitivities - The primary objective of investment activities is to maintain principal safety and liquidity, with cash in excess of current needs invested in money market funds and short-term certificates of deposit (CDs)[165](index=165&type=chunk) - The majority of operating expenses are denominated in U.S. dollars, and the company has not entered into foreign currency forward contracts to hedge exchange rate exposure, though it may do so in the future[166](index=166&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's evaluation of the company's disclosure controls and procedures, concluding their effectiveness - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of **June 30, 2025**[167](index=167&type=chunk) - There were no material changes in internal control over financial reporting during the quarter ended **June 30, 2025**, though the internal control environment is being updated to address changes in financial reporting risks[168](index=168&type=chunk) - The company acknowledges the inherent limitations of internal control over financial reporting, including the possibility of collusion or management override, which may prevent timely detection of material misstatements[169](index=169&type=chunk) [PART II. OTHER INFORMATION](index=32&type=section&id=PART%20II%20OTHER%20INFORMATION) This section provides additional information, including legal proceedings, risk factors, equity sales, and other disclosures [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) This section details the company's ongoing legal proceedings, including patent opposition, a terminated MOU, and a breach of contract claim - An opposition filed by Pixium Vision SA against a European patent owned by Cortigent was abandoned in **February 2025**, and this is not expected to materially affect Cortigent's operations[171](index=171&type=chunk) - The company's appeal in the Paris Commercial Court regarding a terminated Memorandum of Understanding (MOU) with Pixium Vision SA was struck out on **October 23, 2024**, for failure to enforce the judgment, requiring reinstatement within two years[172](index=172&type=chunk) - Oppenheimer & Co. Inc. filed a breach of contract claim seeking no less than **$1,625,000** in damages; the court dismissed all claims except for breach of contract, and both the company and Oppenheimer have filed notices of appeal[174](index=174&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section highlights significant risks to the company's business, including the critical need for additional financing and global economic impacts - The company will require substantial additional financing to pursue its business objectives, including preclinical studies and clinical trials, and there is no assurance that such capital will be available on acceptable terms or at all[177](index=177&type=chunk) - Global economic and political developments, including inflation, capital market disruption, geopolitical conflicts (e.g., Ukraine, Israel-Hamas war), and potential global health crises, could materially and adversely affect the company's business, results of operations, and future growth prospects[178](index=178&type=chunk) - Risks associated with tariffs and other trade restrictions, including those imposed by the U.S. or other countries, could lead to increased costs and operational disruptions for raw materials, active pharmaceutical ingredients (APIs), and other components used in product development and production[179](index=179&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports on a private sale transaction involving common stock to an affiliated entity on May 12, 2025 - On **May 12, 2025**, the company entered into a private sale transaction to sell **2,912,621** shares of common stock to an entity affiliated with one of its directors for approximately **$3.0 million** in gross proceeds[180](index=180&type=chunk) [Item 3. Defaults upon Senior Securities](index=35&type=section&id=Item%203.%20Defaults%20upon%20Senior%20Securities) This section confirms that the company had no defaults upon senior securities during the reported period - The company reported no defaults upon senior securities[181](index=181&type=chunk) [Item 4. Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the company's operations - Mine Safety Disclosures are not applicable to the company[182](index=182&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) This section confirms no Rule 10b5-1 trading plans or non-Rule 10b5-1 arrangements were adopted, modified, or terminated - No Rule 10b5-1 trading plans or non-Rule 10b5-1 trading arrangements were adopted, modified, or terminated by officers or directors during the quarter ended **June 30, 2025**[183](index=183&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section provides a list of all exhibits filed as part of the Form 10-Q, including various agreements and certifications - Exhibits include the Agreement and Plan of Merger (2.1), Certificate of Incorporation (3.1), Bylaws (3.2), Share Purchase Agreement (10.1), and certifications (31.1, 31.2, 32.1)[187](index=187&type=chunk) [SIGNATURES](index=37&type=section&id=SIGNATURES) This section contains the required signatures for the Form 10-Q, certifying its submission by the principal executive and financial officers [SIGNATURES](index=37&type=section&id=SIGNATURES) This section contains the required signatures for the Form 10-Q, certifying its submission by the principal executive and financial officers - The report was signed by Adam Mendelsohn, Chief Executive Officer, and Anthony Baldor, Chief Financial Officer, on **August 13, 2025**[190](index=190&type=chunk)

Core Insights - Vivani Medical, Inc. is advancing the development of its semaglutide implant NPM-139 following positive weight loss data from preclinical studies and the LIBERATE-1 Phase 1 clinical study results for NPM-115 [1][4] - The company has secured $10 million in equity financing to support the accelerated development of NPM-139 and to ensure financial stability into the second half of 2026 [1][3] - Vivani plans to spin off Cortigent, Inc., a division focused on brain implant devices, into an independent publicly traded company [1][15] Financial Overview - As of June 30, 2025, Vivani reported a cash balance of $8.1 million, down from $19.7 million at the end of 2024, primarily due to a net loss of $13.4 million [9] - Research and development expenses for Q2 2025 were $4.8 million, a 35% increase from $3.5 million in Q2 2024, attributed to increased R&D activities [10] - General and administrative expenses rose to $2.7 million in Q2 2025, up 25% from $2.2 million in Q2 2024, mainly due to higher professional services costs [11] Business Developments - The company has entered into a share purchase agreement to issue 7,936,507 shares at $1.26 per share, expected to generate approximately $10 million in gross proceeds [3] - The LIBERATE-1 study demonstrated a positive safety and tolerability profile for NPM-115, which supports the ongoing development of NPM-139 [2] - Vivani anticipates initiating the clinical program for NPM-139 in 2026, with a focus on chronic weight management [2][15] Upcoming Milestones - Vivani plans to provide a detailed update on the NPM-139 program later this year, including the design of a dose-ranging weight maintenance study [15] - The spin-off of Cortigent, Inc. is expected to be completed in Q3 or Q4 of 2025 [15]

[FORM 8-K General Information](index=1&type=section&id=FORM%208-K%20General%20Information) This section details the registrant's corporate identity and the specifics of its publicly traded securities [Registrant Details](index=1&type=section&id=Registrant%20Details) Vivani Medical, Inc. is a Delaware-incorporated registrant with Commission File Number 001-36747, whose common stock is traded on The Nasdaq Capital Market - Registrant: Vivani Medical, Inc[1](index=1&type=chunk) - Jurisdiction of Incorporation: Delaware[1](index=1&type=chunk) - Commission File Number: 001-36747[1](index=1&type=chunk) [Securities Registered](index=1&type=section&id=Securities%20Registered) The company's Common Stock, with a par value of $0.0001 per share, is registered under the trading symbol VANI on The Nasdaq Capital Market Securities Registered | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :---------------------------------- | :---------------- | :---------------------------------------- | | Common Stock, par value $0.0001 per share | VANI | The Nasdaq Capital Market | [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) This section presents preliminary financial information for Q2 2025, including cash position and committed capital, along with important disclaimers [Preliminary Q2 2025 Financial Information](index=2&type=section&id=Preliminary%20Q2%202025%20Financial%20Information) Vivani Medical, Inc. reported preliminary financial information for the second quarter ended June 30, 2025, indicating approximately $6.8 million in cash and cash equivalents and an additional $11.25 million in committed capital expected through March 2026 Preliminary Financial Highlights (Q2 2025) | Metric | Amount (Unaudited) | As of/Through | | :---------------------- | :----------------- | :-------------- | | Cash and Cash Equivalents | $6.8 million | June 30, 2025 | | Committed Capital | $11.25 million | March 2026 | - The committed capital of **$11.25 million** is from two equity purchase agreements entered into in March and May 2025[5](index=5&type=chunk) [Disclaimer on Preliminary Data](index=2&type=section&id=Disclaimer%20on%20Preliminary%20Data) The financial information provided for Q2 2025 is preliminary, unaudited, and subject to revision as the company has not completed its financial closing procedures. Investors are advised to exercise caution as actual results may differ materially - The preliminary financial information is subject to revision based on quarter and year-end closing procedures and adjustments[6](index=6&type=chunk) - The Company's independent registered public accounting firm has not audited, reviewed, or expressed an opinion on this preliminary financial information[6](index=6&type=chunk) - Prospective investors should exercise caution and not draw inferences from this preliminary information, as actual results could be materially different[6](index=6&type=chunk) [Item 7.01 Regulation FD Disclosure](index=2&type=section&id=Item%207.01%20Regulation%20FD%20Disclosure) This section discloses the public announcement of clinical data for NPM-139 and NPM-115 via a press release [Clinical Data Announcement](index=2&type=section&id=Clinical%20Data%20Announcement) On August 5, 2025, Vivani Medical issued a press release announcing rapid advancement of NPM-139 (semaglutide implant) following positive preclinical weight loss data and promising results from the LIBERATE-1 Phase 1 clinical study of NPM-115 - A press release titled 'Vivani Medical Announces Rapid Advancement of NPM-139, a Novel Semaglutide Implant, Following Positive Weight Loss Data from an Ongoing Preclinical Study of NPM-139 and Promising Results from the LIBERATE-1 Phase 1 Clinical Study of NPM-115' was issued on August 5, 2025[7](index=7&type=chunk) [Item 8.01 Other Events](index=2&type=section&id=Item%208.01%20Other%20Events) This section details significant corporate events, including clinical study results for NPM-115, preclinical data for NPM-139, and the company's forward-looking statements [LIBERATE-1 Clinical Data Press Release Overview](index=2&type=section&id=LIBERATE-1%20Clinical%20Data%20Press%20Release%20Overview) Vivani Medical reported results from the LIBERATE-1 Phase 1 study of NPM-115, the first-in-human test of its NanoPortal™ implant technology, and new preclinical feasibility data for NPM-139 (semaglutide implant), leading to the prioritization of NPM-139 in its pipeline - The LIBERATE-1 clinical study is the Phase 1 study of the exenatide GLP-1 implant NPM-115, representing the first-in-human test of the Company's proprietary NanoPortal™ implant technology[10](index=10&type=chunk) - New feasibility data for NPM-139 (semaglutide implant) from an ongoing preclinical study supports its prioritization in the Company's pipeline and clinical development strategy[10](index=10&type=chunk) - Semaglutide is the active ingredient in blockbuster drug products Ozempic, Wegovy, and Rybelsus[10](index=10&type=chunk) [LIBERATE-1 Study Results (NPM-115)](index=3&type=section&id=LIBERATE-1%20Study%20Results%20(NPM-115)) The LIBERATE-1 Phase 1 study successfully met its primary objectives, demonstrating the NPM-115 implant's general safety and tolerability, and characterizing its pharmacokinetic profile over 9 weeks. No serious adverse events or clinically meaningful burst release were observed, supporting the potential for durable delivery - The study successfully met primary objectives to evaluate NPM-115 implant's safety, tolerability, and pharmacokinetic (PK) profile over a 9-week duration[12](index=12&type=chunk) - The implant was generally well tolerated, with no serious adverse events and absence of gastrointestinal adverse events[12](index=12&type=chunk) - The observed release profile over 9 weeks provides encouragement for potential durable delivery over 6 months, as established in preclinical studies for both NPM-115 and NPM-139[12](index=12&type=chunk) [Semaglutide Implant Preclinical Feasibility Data (NPM-139)](index=3&type=section&id=Semaglutide%20Implant%20Preclinical%20Feasibility%20Data%20(NPM-139)) Preclinical studies for NPM-139 (semaglutide implant) have shown significant progress, demonstrating weight loss from a single administration for over 231 days. This data supports an initial target of bi-annual dosing, with future potential for annual dosing, and has led to the prioritization of NPM-139 in the company's development pipeline [NPM-139 Preclinical Weight Loss Data](index=3&type=section&id=NPM-139%20Preclinical%20Weight%20Loss%20Data) Preclinical studies for NPM-139 have demonstrated significant weight loss from a single administration over an extended period, supporting a bi-annual dosing target - An ongoing preclinical study established substantial progress for NPM-139, showing weight loss from a single administration for over **231 days**[14](index=14&type=chunk)[17](index=17&type=chunk) - The emerging preclinical data supports an initial target profile of bi-annual dosing, with anticipation of future annual dosing[17](index=17&type=chunk) [NPM-139 Development Prioritization](index=2&type=section&id=NPM-139%20Development%20Prioritization) The prioritization of NPM-139 is driven by comparable development timelines, established human efficacy of semaglutide, and strong commercial performance of related products - Prioritization of NPM-139 is supported by comparable development timelines with NPM-115, established human weight loss data for semaglutide products, and strong commercial performance of semaglutide-based products (over **$29 billion** in sales in 2024)[11](index=11&type=chunk) - Vivani's near-term efforts are focused on completing PK optimization activities and preparing data for an Investigational New Drug (IND) application for NPM-139[17](index=17&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section contains forward-looking statements regarding the company's business, products, development plans, and financial position, which are subject to inherent uncertainties, risks, and changes in circumstances that could cause actual results to differ materially from expectations - Forward-looking statements are based on current beliefs, expectations, and assumptions, and are subject to risks related to product development and commercialization, regulatory delays, clinical study conduct, and the company's ability to access additional capital[18](index=18&type=chunk) - Actual results and outcomes may differ materially from those indicated, and investors should not rely on these statements[18](index=18&type=chunk) - The company undertakes no obligation to publicly update any forward-looking statement, except as required by law[18](index=18&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=4&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the financial statements and exhibits included in the filing, along with the official signatures [Exhibits List](index=4&type=section&id=Exhibits%20List) The report includes Exhibit 99.1, a press release issued by Vivani Medical, Inc. on August 5, 2025, and Exhibit 104, the Cover Page Interactive Data File Exhibits | Exhibit No. | Description | | :---------- | :------------------------------------------------------------------------ | | 99.1 | Press release issued by Vivani Medical, Inc. on August 5, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=5&type=section&id=Signatures) The Current Report on Form 8-K was duly signed on behalf of Vivani Medical, Inc. by Donald Dwyer, Chief Business Officer, on August 5, 2025 - The report was signed by Donald Dwyer, Chief Business Officer of Vivani Medical, Inc[24](index=24&type=chunk) - Date of signature: August 5, 2025[24](index=24&type=chunk)

Core Insights - Vivani Medical, Inc. has reported positive results from the LIBERATE-1 clinical study, which is the first-in-human application of its NanoPortal implant technology, demonstrating a favorable safety and tolerability profile for the NPM-115 implant [1][3][4] - The company has also presented preclinical feasibility data for the NPM-139 semaglutide implant, indicating approximately 20% weight loss maintained for over 6 months with a single implant, supporting the potential for annual dosing [1][2][3] - Based on these findings, Vivani is prioritizing the advancement of NPM-139, with clinical development expected to commence in 2026, pending regulatory clearance [1][3][11] LIBERATE-1 Study Results - The LIBERATE-1 Phase 1 study successfully met its primary objectives, evaluating the safety and tolerability of the NPM-115 implant and characterizing its pharmacokinetic profile over a 9-week duration [4][5] - The study found that the implant was generally well tolerated, with no serious adverse events reported, and the drug release profile showed promise for durable delivery over a 6-month period [4][5] NPM-139 (Semaglutide Implant) Development - The preclinical study for NPM-139 has shown significant weight loss results, with a single administration leading to weight loss sustained for over 231 days [7][11] - The company believes that the development timelines for NPM-115 and NPM-139 are comparable, and the established success of semaglutide products in the market supports the confidence in NPM-139 [3][12] - Semaglutide-based products, including Ozempic, Wegovy, and Rybelsus, generated over $29 billion in sales in 2024, indicating strong commercial potential for NPM-139 [3][12]