Core Insights - Vivani Medical, Inc. has appointed Anthony Baldor as Chief Financial Officer, succeeding Brigid A. Makes, who is retiring to focus on other commitments [1][3] - Baldor has over 20 years of financial management experience in the biotechnology sector, with a strong background in fundraising and corporate strategy [2] - The CEO of Vivani, Adam Mendelsohn, expressed confidence in Baldor's expertise to advance the company's pipeline and operations during a critical period [3] Company Overview - Vivani Medical develops miniature, ultra long-acting drug implants using its proprietary NanoPortal™ platform, aimed at improving medication adherence and patient tolerance [4] - The lead program, NPM-115, is a six-month GLP-1 implant for chronic weight management, with additional products in the pipeline, including NPM-139 and NPM-119, targeting similar therapeutic areas [4] - Medication non-adherence affects approximately 50% of patients, contributing to over $500 billion in annual avoidable healthcare costs and 125,000 preventable deaths in the U.S. [4]

Core Viewpoint - Vivani Medical, Inc. is preparing to present its innovative drug implant technology at the 2025 BIO International Convention, highlighting its potential to improve medication adherence and patient outcomes in chronic disease management [1][4]. Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing miniature, ultra long-acting drug implants using its proprietary NanoPortal™ technology [3]. - The company's lead program, NPM-115, is a six-month GLP-1 (exenatide) implant aimed at chronic weight management for obese or overweight individuals [1][3]. - Vivani's emerging pipeline includes NPM-139 (semaglutide implant) and NPM-119, both designed for chronic weight management and type 2 diabetes treatment, respectively [3]. Industry Context - Medication non-adherence affects approximately 50% of patients, contributing to over $500 billion in annual avoidable healthcare costs and 125,000 preventable deaths in the U.S. [4]. - The current GLP-1 landscape features over 50 new molecular entities in clinical development, with Vivani's differentiated portfolio of miniature implants positioned as a promising therapeutic option [4].

Core Viewpoint - Vivani Medical, Inc. plans to spin off its subsidiary Cortigent, Inc. into an independent publicly traded company on Nasdaq by the third quarter of 2025, aiming to enhance value for both Vivani and Cortigent stockholders [1][3][6] Company Developments - Cortigent is developing the Orion Visual Cortical Prosthesis System to provide visual perception for the blind and a Stroke Recovery System to aid recovery of arm and hand movement post-stroke [1][8] - The Orion system has received FDA Breakthrough Device designation and completed a six-year Early Feasibility Study with promising results [2][8] - Cortigent's previous product, the Argus II, was the first FDA-authorized artificial vision device, successfully implanted in hundreds of patients [2][8] Strategic Focus - The spin-off will allow Vivani to concentrate on its proprietary NanoPortal drug implant technology, specifically for chronic weight management and type 2 diabetes [1][2][3] - Vivani's lead program includes a six-month subdermal GLP-1 implant for chronic weight management, with additional products in development for type 2 diabetes [9][11] Financial and Operational Structure - The spin-off is expected to provide clearer visibility into the financial and operational structures of both companies, enhancing understanding of their respective strategies and risks [5][10] - The transaction is subject to various conditions, including board approval and SEC and Nasdaq compliance [6] Management and Leadership - Cortigent's CEO, Jonathan Adams, has extensive experience in the biopharmaceutical field and aims to accelerate the development of Cortigent's technologies post-spin-off [2][8]

[PART I FINANCIAL INFORMATION](index=2&type=section&id=PART%20I) This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis for the reported period [Item 1. Financial Statements (unaudited)](index=2&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited condensed consolidated financial statements, including the balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed notes providing context and breakdowns of accounting policies, segment information, equity activities, and commitments [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20March%2031%2C%202025%20and%20December%2031%2C%202024) This section provides a comparative overview of the company's financial position at the end of March 2025 and December 2024 | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (QoQ) | | :-------------------------- | :----------------------------- | :------------------------------ | :----------- | | Total Assets | $35,452 | $41,561 | -$6,109 | | Total Liabilities | $23,828 | $23,951 | -$123 | | Total Stockholders' Equity | $11,624 | $17,610 | -$5,986 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20three%20months%20ended%20March%2031%2C%202025%20and%202024) This section details the company's financial performance, including revenues, expenses, and net loss, for the three months ended March 31, 2025 and 2024 | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | Change (YoY) | | :---------------------------------- | :------------------------------------------ | :------------------------------------------ | :----------- | | Research and development, net of grants | $4,217 | $3,726 | +$491 | | General and administrative, net of grants | $2,340 | $2,501 | -$161 | | Total operating expenses | $6,557 | $6,227 | +$330 | | Net loss | $(6,302) | $(6,039) | -$(263) | | Net loss per common share - basic and diluted | $(0.11) | $(0.12) | +$0.01 | [Condensed Consolidated Statements of Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss%20for%20the%20three%20months%20ended%20March%2031%2C%202025%20and%202024) This section presents the company's comprehensive loss, including net loss and other comprehensive income items, for the three months ended March 31, 2025 and 2024 | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | Change (YoY) | | :-------------------------- | :------------------------------------------ | :------------------------------------------ | :----------- | | Net loss | $(6,302) | $(6,039) | -$(263) | | Foreign currency translation adjustments | $(6) | $(52) | +$46 | | Comprehensive loss | $(6,308) | $(6,091) | -$(217) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20for%20each%20three%20months%20ended%20March%2031%2C%202025%20and%202024) This section outlines changes in the company's stockholders' equity, reflecting net loss, stock-based compensation, and stock issuances, for the three months ended March 31, 2025 and 2024 | Metric | Balance, January 1, 2025 (in thousands) | Balance, March 31, 2025 (in thousands) | Change | | :-------------------------- | :------------------------------------- | :------------------------------------ | :------- | | Total Stockholders' Equity | $17,610 | $11,624 | -$5,986 | | Net loss (Q1 2025) | - | $(6,302) | | | Stock-based compensation expense (Q1 2025) | - | $350 | | | Issuance of common stock (net) (Q1 2025) | - | $(28) | | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20three%20months%20ended%20March%2031%2C%202025%20and%202024) This section summarizes the company's cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2025 and 2024 | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | Change (YoY) | | :---------------------------------- | :------------------------------------------ | :------------------------------------------ | :----------- | | Net cash used in operating activities | $(5,163) | $(4,512) | -$(651) | | Net cash used in investing activities | $(5) | $(182) | +$177 | | Net cash used in financing activities | $(170) | $13,690 | -$(13,860) | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(5,344) | $8,994 | -$(14,338) | | Cash, cash equivalents and restricted cash balance at end of period | $14,346 | $30,986 | -$(16,640) | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and breakdowns of the accounting policies, significant transactions, and financial statement line items [Note 1. Organization and Business Operations](index=8&type=section&id=Note%201.%20Organization%20and%20Business%20Operations) This note describes the company's core business, its drug development programs, strategic initiatives, and current operational status - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company developing miniaturized, subdermal drug implants using its NanoPortal™ technology for chronic disease treatment, focusing on medication non-adherence[24](index=24&type=chunk)[25](index=25&type=chunk)[108](index=108&type=chunk) - Lead programs include NPM-115 (six-month GLP-1 implant for chronic weight management), NPM-139 (semaglutide implant for chronic weight management), NPM-119 (exenatide implant for type 2 diabetes), and OKV-119 (GLP-1 implant for cardiometabolic disorders in animals, in collaboration with Okava)[26](index=26&type=chunk)[110](index=110&type=chunk) - The company is pursuing a spin-off of its Neurostimulation Division (Cortigent) into an independent public company, shifting from an IPO strategy announced in March 2025[28](index=28&type=chunk)[112](index=112&type=chunk) - The FDA lifted the clinical hold on NPM-119 on June 13, 2024, allowing the first-in-human study for type 2 diabetes to proceed. The LIBERATE-1™ study for NPM-115 (exenatide implant) in obese/overweight patients initiated screening and enrollment in Australia at the end of 2024, with the first implant administered and full enrollment achieved by March 13, 2025; top-line results are anticipated in mid-2025[30](index=30&type=chunk)[36](index=36&type=chunk)[41](index=41&type=chunk) - Management estimates that currently available cash will provide sufficient funds for at least the next twelve months, but continued operation as a going concern depends on developing profitable operations or raising additional capital[45](index=45&type=chunk)[142](index=142&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 accounting principles applied in preparing the financial statements and discusses recently issued accounting pronouncements - The company operates with two reporting segments: Biopharm Division (primary focus, includes NPM and Vivani Medical Australia Pty Ltd.) and Neurostimulation Division (includes Cortigent and Swiss subsidiary, planned for spin-off). Neither division is currently revenue-producing[50](index=50&type=chunk)[102](index=102&type=chunk) - Recently issued accounting pronouncements include ASU 2024-03 (Disaggregation of Income Statement Expenses, effective Jan 1, 2027) and ASU 2023-09 (Improvements to Income Tax Disclosures, effective after Dec 15, 2024). The company does not expect a material effect from ASU 2024-03[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 identifies key financial and operational risks, including credit risk from financial instruments and risks associated with foreign operations - The company's financial instruments (cash, certificates of deposit, and money market funds) are subject to credit risk, managed by maintaining funds with reputable financial institutions[55](index=55&type=chunk) - Foreign operations include assets in Switzerland (approx. **$26,000** as of March 31, 2025 and 2024) and Australia (approx. **$557,000** as of March 31, 2025, up from **$21,000** in 2024), with potential for disruption from unanticipated events[56](index=56&type=chunk) [Note 4. Fair Value Measurements](index=13&type=section&id=Note%204.%20Fair%20Value%20Measurements) This note details the fair value hierarchy and measurements for the company's financial assets, primarily cash equivalents | Asset Category | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------- | :----------------------------- | :------------------------------ | | Certificates of deposit | $7,267 | $9,996 | | Money market funds | $4,805 | $7,441 | | Total Cash equivalents | $12,072 | $17,437 | [Note 5. Insurance Premium Financing](index=13&type=section&id=Note%205.%20Insurance%20Premium%20Financing) This note describes the company's financing arrangement for insurance premiums, including the principal amount and interest rate - In September 2024, the company entered a finance agreement for insurance premiums totaling approximately **$426,000** at **7.2% interest**. The outstanding balance as of March 31, 2025, was approximately **$95,000**[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 specific details for selected balance sheet accounts, such as property and equipment | Asset Category | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------ | | Property and equipment, net | $1,609 | $1,693 | [Note 7. Equity Securities](index=14&type=section&id=Note%207.%20Equity%20Securities) This note details the company's equity structure, including common stock outstanding, recent offerings, and private sales - As of March 31, 2025, Vivani had **59,243,903** shares of common stock outstanding, with **300,000,000** authorized. No preferred stock was issued[66](index=66&type=chunk) - In March 2024, the company completed a registered direct offering, selling **3,947,368** common shares and warrants for **$3.80 per unit**, generating **$13.7 million** in net proceeds after **$1.3 million** in issuance costs[67](index=67&type=chunk)[119](index=119&type=chunk)[132](index=132&type=chunk) - An Open Market Sale Agreement (ATM) with Jefferies LLC, effective April 22, 2024, allows the company to sell up to **$75.0 million** in common stock. During Q1 2025, **9,215** shares were issued for **$10,000** gross proceeds, resulting in negative net proceeds of **$28,000** after **$37,000** in expenses[68](index=68&type=chunk)[71](index=71&type=chunk)[120](index=120&type=chunk) - The company completed a private sale transaction on November 8, 2024, selling **3,968,253** shares to a director for **$5.0 million**. Another private sale on March 26, 2025, will sell **7,366,071** shares to an affiliated entity for approximately **$8.25 million**[72](index=72&type=chunk)[73](index=73&type=chunk)[126](index=126&type=chunk) [Note 8. Warrants](index=15&type=section&id=Note%208.%20Warrants) This note provides information on outstanding warrants, including their quantity, weighted average exercise price, and remaining contractual life | Metric | December 31, 2024 | March 31, 2025 | Change | | :-------------------------------- | :---------------- | :--------------- | :----- | | Warrants outstanding (in thousands) | 9,340 | 8,569 | -771 | | Weighted Average Exercise Price | $3.42 | $3.45 | +$0.03 | | Weighted Average Remaining Contractual Life (in Years) | 1.6 | 1.5 | -0.1 | [Note 9. Stock-Based Compensation](index=15&type=section&id=Note%209.%20Stock-Based%20Compensation) This note details the company's stock option and RSU activity, along with the associated stock-based compensation expense recognized | Metric | December 31, 2024 | March 31, 2025 | Change | | :------------------------------------------------ | :---------------- | :--------------- | :----- | | Stock Options outstanding (in thousands) | 6,809 | 7,051 | +242 | | Weighted Average Exercise Price (Stock Options) | $2.52 | $2.47 | -$0.05 | | RSUs outstanding (in thousands) | 695 | 695 | 0 | | Expense Category | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | Change (YoY) | | :-------------------------- | :------------------------------------------ | :------------------------------------------ | :----------- | | Research and development | $196 | $235 | -$39 | | General and administrative | $154 | $118 | +$36 | | Total stock-based compensation expense | $350 | $353 | -$3 | [Note 10. Net Loss Per Share](index=18&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 anti-dilutive securities | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change (YoY) | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | :----------- | | Net loss per common share - basic and diluted | $(0.11) | $(0.12) | +$0.01 | | Weighted average common shares outstanding - basic and diluted (in thousands) | 59,236 | 52,202 | +7,034 | | Anti-dilutive Securities (in thousands) | March 31, 2025 | March 31, 2024 | | :-------------------------------------- | :--------------- | :--------------- | | Stock options | 7,051 | 5,880 | | Unvested restricted stock units | 695 | 403 | | Warrants to purchase common stock | 8,569 | 10,961 | | Total | 16,315 | 17,244 | [Note 11. Right-of-use Assets and Operating Lease Liabilities](index=18&type=section&id=Note%2011.%20Right-of-use%20Assets%20and%20Operating%20Lease%20Liabilities) This note details the company's operating lease assets and liabilities, including lease terms and discount rates | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------ | | Operating lease right-of-use assets, net | $17,523 | $17,957 | | Lease liability, current portion | $1,311 | $1,348 | | Lease liability, noncurrent portion | $17,629 | $17,965 | | Total lease liabilities | $18,940 | $19,313 | | Lease Cost | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :-------------------- | :------------------------------------------ | :------------------------------------------ | | Operating lease cost | $800 | $800 | | Variable lease cost | $200 | $100 | - Weighted average remaining lease term is **8.50 years** with a weighted average discount rate of **8.38%** as of March 31, 2025[95](index=95&type=chunk) [Note 12. Commitments and Contingencies](index=20&type=section&id=Note%2012.%20Commitments%20and%20Contingencies) This note discloses the company's legal proceedings, patent challenges, and other contractual obligations - The company abandoned a European patent challenged by Pixium Vision SA in February 2025, which is not expected to materially affect operations[98](index=98&type=chunk)[172](index=172&type=chunk) - Ongoing litigation with Pixium Vision SA regarding a terminated MOU. The Paris Commercial Court ordered Vivani to pay **€2.5 million** (net **€1.55 million** after credit), which Vivani appealed. Vivani's appeal was struck out on October 23, 2024, for failure to enforce the judgment, but can be reinstated within two years upon evidence of enforcement or agreement[99](index=99&type=chunk)[100](index=100&type=chunk)[173](index=173&type=chunk) - Clinical trial expenses were **$35,000** for the three months ended March 31, 2025, compared to **$6,000** for the same period in 2024[97](index=97&type=chunk) [Note 13. Segment Information](index=21&type=section&id=Note%2013.%20Segment%20Information) This note provides financial data disaggregated by the company's operating segments: Biopharm and Neurostimulation Divisions | Segment | Operating Expenses (Q1 2025, in thousands) | Net Loss (Q1 2025, in thousands) | Total Assets (March 31, 2025, in thousands) | | :-------------------- | :---------------------------------------- | :------------------------------- | :------------------------------------------ | | Biopharm Division | $6,000 | $5,600 | $34,700 | | Neurostimulation Division | $600 | $700 | $700 | [Note 14. Subsequent Event](index=21&type=section&id=Note%2014.%20Subsequent%20Event) This note describes significant events that occurred after the balance sheet date but before the financial statements were issued - On May 12, 2025, the company entered a private sale agreement to sell **2,912,621** shares of common stock to an affiliated entity for approximately **$3.0 million**[106](index=106&type=chunk)[130](index=130&type=chunk)[137](index=137&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations, including a business overview, details on funding and liquidity, critical accounting policies, and a comparative analysis of operating expenses and other income for the reported periods [Business Overview](index=22&type=section&id=Business%20Overview) This section provides an overview of the company's biopharmaceutical focus, NanoPortal™ technology, and key drug development programs - Vivani is a clinical-stage biopharmaceutical company focused on developing miniaturized, subdermal drug implants using its NanoPortal™ technology to address medication non-adherence in chronic diseases[108](index=108&type=chunk)[109](index=109&type=chunk) - Key programs include NPM-115 (GLP-1 implant for weight management), NPM-139 (semaglutide implant for weight management), NPM-119 (exenatide implant for type 2 diabetes), and OKV-119 (GLP-1 implant for animal cardiometabolic disorders)[110](index=110&type=chunk) - The company is pursuing a spin-off of its Neurostimulation Division (Cortigent) into an independent public company, shifting from an IPO strategy[112](index=112&type=chunk) - The LIBERATE-1 clinical trial for NPM-115 (exenatide implant) in obese and overweight patients initiated screening and enrollment in Australia at the end of 2024, with the first implant administered and full enrollment achieved by March 13, 2025. Top-line results are expected in mid-2025[125](index=125&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk) [Funding and Liquidity](index=24&type=section&id=Funding%20and%20Liquidity) This section discusses the company's primary sources of funding, including equity sales and grants, and its capital-raising activities - Operations are primarily funded through equity sales. Recent activities include a March 2024 registered direct offering (**$13.7 million** net proceeds), an April 2024 Open Market Sale Agreement (up to **$75.0 million**), a November 2024 private sale (**$5.0 million**), and a March 2025 private sale (**$8.25 million**)[131](index=131&type=chunk)[132](index=132&type=chunk)[133](index=133&type=chunk) - The company also receives grants, such as from the NIH, to fund specific development programs, with **$35,000** received in Q1 2025[138](index=138&type=chunk) [Liquidity](index=25&type=section&id=Liquidity) This section assesses the company's ability to meet its short-term and long-term financial obligations, highlighting cash position and working capital - The company has incurred recurring operating losses and negative operating cash flows since inception and expects this to continue, necessitating additional capital to fund operations and clinical trials[139](index=139&type=chunk)[140](index=140&type=chunk)[157](index=157&type=chunk) - Management estimates currently available cash will provide sufficient funds for at least the next twelve months, but continued operation as a going concern depends on developing profitable operations or raising additional capital[142](index=142&type=chunk)[156](index=156&type=chunk) | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | Change | | :------------------------------------------ | :----------------------------- | :------------------------------ | :------- | | Cash, cash equivalents and restricted cash | $14,300 | $19,700 | -$5,400 | | Working capital | $8,700 | $14,500 | -$5,800 | | Cash Flow Activity | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :-------------------------------- | :------------------------------------------ | :------------------------------------------ | | Net cash used in operating activities | $(5,200) | $(4,500) | | Net cash used in investing activities | $(5) | $(200) | | Net cash used in financing activities | $(170) | $13,700 | [Critical Accounting Policies and Estimates](index=27&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section identifies the accounting policies that require significant judgment and estimates, which are crucial to the financial statements - No material changes to critical accounting policies were reported during the three months ended March 31, 2025, compared to the fiscal year ended December 31, 2024[144](index=144&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance by comparing operating expenses and other income for the reported periods | Operating Expense | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | Change (YoY) | | :-------------------------- | :------------------------------------------ | :------------------------------------------ | :----------- | | Research and development | $4,200 | $3,700 | +$500 | | General and administrative | $2,300 | $2,500 | -$200 | | Other income, net | $300 | $200 | +$100 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section outlines the company's exposure to market risks, specifically focusing on interest rate sensitivity related to cash equivalents and exchange rate sensitivity for foreign operations, and the strategies (or lack thereof) to manage these risks - The company's investment activities prioritize safety of principal and liquidity, with cash invested in money market funds and short-term certificates of deposit, which are generally not subject to significant interest rate risk[167](index=167&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[168](index=168&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's evaluation of the effectiveness of the company's disclosure controls and procedures, concluding their effectiveness, and reports on any changes in internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2025[169](index=169&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter, though the company is updating its internal control environment to address changes in risks, staffing, and segregation of duties[170](index=170&type=chunk) [PART II OTHER INFORMATION](index=28&type=section&id=PART%20II) This section provides additional disclosures on legal proceedings, risk factors, equity sales, and other relevant corporate information [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) This section provides updates on significant legal matters, including the abandonment of a European patent and the ongoing appeal related to litigation with Pixium Vision SA concerning a terminated business combination - The company abandoned a European patent in February 2025, which was challenged by Pixium Vision SA, and does not expect a material impact on operations[172](index=172&type=chunk) - Vivani is appealing a Paris Commercial Court judgment ordering it to pay Pixium Vision SA approximately **€1.55 million**. The appeal was struck out on October 23, 2024, for failure to enforce the judgment, but can be reinstated within two years[173](index=173&type=chunk)[174](index=174&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section highlights key risks facing the company, including the substantial need for additional financing, the inherent uncertainties and high costs of pharmaceutical development, and potential adverse impacts from global economic and political developments, such as inflation, geopolitical conflicts, and trade policy changes - The company requires substantial additional financing for product development and commercialization, which may not be available on acceptable terms, potentially forcing delays or termination of programs[177](index=177&type=chunk) - Global economic and political developments, including inflation, capital market disruptions, geopolitical conflicts (e.g., Russia-Ukraine, Israel-Hamas), and potential health crises, could materially and adversely affect the business, including the ability to raise capital and supply chain stability[178](index=178&type=chunk) - Recent changes to U.S. trade policies, sanctions, and tariffs could lead to higher input costs and negatively impact global economic conditions, potentially affecting the company's financial results[179](index=179&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section discloses recent unregistered sales of equity securities, specifically a private sale transaction in March 2025 to an affiliated entity, detailing the number of shares and gross proceeds - On March 26, 2025, the company entered into a private sale transaction to sell **7,366,071** shares of common stock to an affiliated entity for approximately **$8.25 million**[180](index=180&type=chunk) [Item 3. Defaults upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20upon%20Senior%20Securities) This section confirms that the company has not experienced any defaults upon senior securities during the reporting period - The company reported no defaults upon senior securities during the period[181](index=181&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that the disclosures related to mine safety are not applicable to the company's operations - This item is not applicable to the company[182](index=182&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) This section provides miscellaneous information, including the adoption of an amended executive severance policy and disclosures regarding Rule 10b5-1 trading plans by officers and directors - The company adopted an Amended and Restated Executive Severance Policy as of April 29, 2025, providing severance benefits under specific termination conditions related to a change in control[183](index=183&type=chunk) - 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 March 31, 2025[184](index=184&type=chunk) [Item 6. Exhibits](index=35&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, providing references to various agreements, corporate documents, and certifications - The exhibit index lists various documents filed, including merger agreements, corporate governance documents, share purchase agreements, the amended severance policy, and certifications[187](index=187&type=chunk)[188](index=188&type=chunk) [SIGNATURES](index=36&type=section&id=SIGNATURES) This section formally attests to the accuracy and completeness of the financial report by the company's principal executive and financial officers - The report is signed by Adam Mendelsohn, Chief Executive Officer, and Brigid A. Makes, Chief Financial Officer, on May 13, 2025[190](index=190&type=chunk)[191](index=191&type=chunk)

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 ...

Core Insights - Vivani Medical, Inc. is advancing its proprietary NanoPortal™ implant technology through the ongoing LIBERATE-1 study, which has successfully inserted a miniature, ultra long-acting GLP-1 (exenatide) implant in all subjects, with top-line results expected in mid-2025 [1][2][15] - The company has secured its financial position through a new $3 million equity financing, in addition to a previously reported $8.25 million financing, ensuring funding through mid-2026 [1][3] - Promising pre-clinical data for NPM-139 (semaglutide implant) has been released, indicating potential for chronic weight management in obese and overweight patients [1][5] Business Developments - Vivani plans to spin off Cortigent, Inc., a division focused on brain implant devices, into an independent publicly traded company to enhance focus on their respective therapeutic areas [1][8] - The collaboration with Okava Pharmaceuticals has expanded to include dogs in the development of a long-acting GLP-1 therapy, OKV-119, leveraging Vivani's NanoPortal technology [4] Financial Performance - As of March 31, 2025, Vivani reported a cash balance of $14.3 million, down from $19.7 million at the end of 2024, primarily due to a net loss of $6.3 million [10] - Research and development expenses increased by 13% to $4.2 million compared to the same period in 2024, reflecting heightened activity in the Biopharma division [11] - General and administrative expenses decreased by 6% to $2.3 million, attributed to reduced professional services and personnel costs [12] Market Position and Strategy - The GLP-1 market is growing, but new entrants must differentiate themselves due to the established clinical benefits of existing therapies; Vivani's miniature, long-acting implants aim to improve medication adherence and patient outcomes [2][16] - The company anticipates that its differentiated portfolio of GLP-1 implants will provide a compelling alternative treatment option for patients and healthcare providers [2][16]

Core Viewpoint - Vivani Medical, Inc. is advancing its innovative miniature drug implants aimed at improving patient adherence in chronic disease treatment, particularly in the GLP-1 drug class [1][4][5] Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing ultra long-acting drug implants using its proprietary NanoPortal™ technology [1][4] - The company's lead programs include NPM-115 (exenatide implant) for weight management and NPM-139 (semaglutide implant) for chronic weight management, both designed for infrequent administration [4] Upcoming Events - CEO Adam Mendelsohn will present at the AAPS workshop on May 14, 2025, discussing advances in drug delivery and patient adherence [2][3] - The presentation will focus on the company's lead program, NPM-115, with results from the LIBERATE-1™ study expected this year [2] Industry Context - Medication non-adherence affects approximately 50% of patients, contributing to over $500 billion in avoidable healthcare costs and 125,000 preventable deaths annually in the U.S. [5] - The current GLP-1 landscape includes over 50 new molecular entities in clinical development, highlighting the competitive environment in which Vivani operates [5]

Core Viewpoint - Vivani Medical, Inc. is advancing its miniature, ultra long-acting drug implants aimed at improving patient adherence in chronic disease treatment, particularly in the GLP-1 drug class [1][4][5] Company Overview - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutic implants using its proprietary NanoPortal™ technology [4] - The company’s lead programs include NPM-115 (exenatide implant) and NPM-139 (semaglutide implant), designed for chronic weight management with administration once or twice a year [4] - Vivani is also developing NPM-119, a six-month GLP-1 implant for type 2 diabetes treatment [4] Upcoming Events - CEO Adam Mendelsohn will present on "Addressing Patient Adherence: Advances in Drug Delivery" at the AAPS workshop on May 14, 2025 [2] - A panel discussion featuring Dr. Mendelsohn will address key hurdles and trends in GLP-1 drug development on the same day [3] Market Context - Medication non-adherence affects approximately 50% of patients, contributing to over $500 billion in annual avoidable healthcare costs and 125,000 preventable deaths in the U.S. [5] - The current GLP-1 landscape includes over 50 new molecular entities in clinical development, positioning Vivani's differentiated portfolio as a potential attractive option for patients and healthcare providers [5]

Core Insights - Vivani Medical, Inc. is developing miniature, ultra long-acting GLP-1 implants for chronic weight management and type 2 diabetes, with topline data from the LIBERATE-1 clinical trial expected in mid-2025 [1][2][3] Company Overview - Vivani Medical utilizes its proprietary NanoPortal platform to create therapeutic implants that deliver drug molecules steadily over extended periods, aiming to improve medication adherence and patient tolerance [3] - The company's lead programs include NPM-139 (semaglutide implant) and NPM-115 (exenatide implant), designed for once or twice-yearly administration for chronic weight management [3] - Vivani is also developing NPM-119, a six-month subdermal GLP-1 implant for type 2 diabetes treatment, and is considering a semaglutide implant for the same condition [3] Industry Context - Medication non-adherence affects approximately 50% of patients, contributing to over $500 billion in annual avoidable healthcare costs and 125,000 preventable deaths in the U.S. [4] - The current GLP-1 landscape includes over 50 new molecular entities in clinical development, but Vivani's differentiated portfolio of miniature, ultra long-acting GLP-1 implants is positioned as a promising therapeutic option [4]

Core Insights - Vivani Medical, Inc. is developing miniature, ultra long-acting GLP-1 implants for chronic weight management and type 2 diabetes, with topline data from the LIBERATE-1 clinical trial expected in mid-2025 [1][2][3] Company Overview - Vivani Medical utilizes its proprietary NanoPortal platform to create therapeutic implants that deliver drug molecules steadily over extended periods, aiming to improve patient adherence and tolerance [3] - The company's lead programs include NPM-139 (semaglutide implant) and NPM-115 (exenatide implant), designed for once or twice-yearly administration for chronic weight management [3] - Vivani is also developing NPM-119, a six-month subdermal GLP-1 implant for type 2 diabetes treatment, and is considering a semaglutide implant for the same condition [3] Clinical Trial Information - The LIBERATE-1 trial is a first-in-human study of the NPM-115 implant, with results anticipated in mid-2025 [2][3] - The company is actively engaging with investors and stakeholders through events such as a virtual fireside chat scheduled for April 24, 2025 [2] Industry Context - Medication non-adherence affects approximately 50% of patients, contributing to over $500 billion in annual avoidable healthcare costs and 125,000 preventable deaths in the U.S. [4] - Vivani's differentiated portfolio of GLP-1 implants aims to address the challenges of medication adherence faced by patients with obesity and type 2 diabetes [4]