Vivani Medical(VANI) - 2025 Q2 - Quarterly Results

FORM 8-K General Information This section details the registrant's corporate identity and the specifics of its publicly traded securities Registrant Details 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] - Jurisdiction of Incorporation: Delaware[1] - Commission File Number: 001-36747[1] Securities Registered 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 This section presents preliminary financial information for Q2 2025, including cash position and committed capital, along with important disclaimers Preliminary Q2 2025 Financial Information 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] Disclaimer on Preliminary Data 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] - The Company's independent registered public accounting firm has not audited, reviewed, or expressed an opinion on this preliminary financial information[6] - Prospective investors should exercise caution and not draw inferences from this preliminary information, as actual results could be materially different[6] Item 7.01 Regulation FD Disclosure This section discloses the public announcement of clinical data for NPM-139 and NPM-115 via a press release Clinical Data Announcement 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] Item 8.01 Other Events 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 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] - 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] - Semaglutide is the active ingredient in blockbuster drug products Ozempic, Wegovy, and Rybelsus[10] LIBERATE-1 Study Results (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] - The implant was generally well tolerated, with no serious adverse events and absence of gastrointestinal adverse events[12] - 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] Semaglutide Implant Preclinical Feasibility Data (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 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][17] - The emerging preclinical data supports an initial target profile of bi-annual dosing, with anticipation of future annual dosing[17] NPM-139 Development Prioritization 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] - 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] Forward-Looking Statements 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] - Actual results and outcomes may differ materially from those indicated, and investors should not rely on these statements[18] - The company undertakes no obligation to publicly update any forward-looking statement, except as required by law[18] Item 9.01 Financial Statements and Exhibits This section lists the financial statements and exhibits included in the filing, along with the official signatures Exhibits List 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 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] - Date of signature: August 5, 2025[24]