{"url_path":"/sec/vani/10-q/2026/cover-page","section_key":"cover-page","section_title":"Cover Page","topic":"sec","document":{"doc_type":"10-Q","doc_date":"2026-05-13","source_url":"https://www.sec.gov/Archives/edgar/data/1266806/0001753926-26-000852-index.html","accession_number":"0001753926-26-000852","cik":"0001266806","ticker":"VANI","issuer_name":"Vivani Medical, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1266806/0001753926-26-000852-index.html","primary_entity_key":"0001266806","primary_entity_name":"Vivani Medical, 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STATES\n\nSECURITIES AND EXCHANGE COMMISSION\n\nWashington, D.C. 20549 \n\n \n\nFORM 10-Q\n\n \n\n(Mark One) \n\n☒\n\nQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934\n\n \n\nFor the quarterly period ended March 31, 2026\n\n \n\nor\n\n \n\n☐\n\nTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934\n\n \n\nFor the transition period from ________ to ________\n\n \n\nCommission File Number: 001-36747\n\n \n\nVivani Medical, Inc. \n\n(Exact name of registrant as specified in its charter)\n\n \n\nDelaware\n\n \n\n02-0692322\n\n(State or other jurisdiction of incorporation or organization)\n\n1350 S. Loop Road, Alameda, CA\n\n(Address of principal executive offices)\n\n \n\n(I.R.S. Employer Identification No.)\n\n94502\n\n(Zip Code)\n\n \n\n(415) 506-8462\n\nRegistrant’s telephone number, including area code\n\n \n\nSecurities registered pursuant to Section 12(b) of the Act:\n\n \n\nTitle of each class\n\n \n\nTrading Symbol(s)\n\n \n\nName of each exchange on which registered\n\nCommon Stock, par value $0.0001 per share\n\n \n\nVANI\n\n \n\nThe Nasdaq Capital Market\n\n \n\nIndicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.                                            Yes ☒  No ☐\n\n \n\nIndicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).                                                                                      Yes ☒  No ☐\n\n \n\nIndicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.\n\n \n\nLarge accelerated filer\n\n☐\n\n \n\nAccelerated filer\n\n☐\n\nNon-accelerated filer\n\n☒\n\n \n\nSmaller reporting company\n\n☒\n\n \n\n \n\n \n\nEmerging growth company\n\n☐\n\n \n\nIf an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐\n\n \n\nIndicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).   Yes ☐  No ☒\n\n \n\nAs of May 12, 2026, the registrant had 86,235,104 shares of common stock, par value $0.0001 per share outstanding.\n\n \n\n \n\n \n\nVIVANI MEDICAL, INC.\n\nAND SUBSIDIARIES\n\n \n\nFORM 10-Q\n\nTABLE OF CONTENTS\n\n \n\n \n\n####  \n\n####  \n\n[PART I](#bm_4458b4142cf552ee)\n\n[FINANCIAL INFORMATION](#bm_4458b4142cf552ee)\n\n4\n\n \n\n \n\n \n\n[Item 1.](#bm_e971ae1816a2ba12)\n\n[Financial Statements (Unaudited)](#bm_e971ae1816a2ba12)\n\n4\n\n \n\n \n\n \n\n \n\n[Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 2025](#bm_a852d79bb0708dc4)\n\n4\n\n \n\n[Condensed Consolidated Statements of Operations for the three months ended March 31, 2026 and 2025](#bm_af1d01e3565d8bdc)\n\n5\n\n \n\n[Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2026 and 2025](#bm_c57583aa30214d2e)\n\n6\n\n \n\n[Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2026 and 2025](#bm_f5b26036da37b505)\n\n7\n\n \n\n[Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2026 and 2025](#bm_ed9e743d0ee2ac91)\n\n8\n\n \n\n[Notes to Condensed Consolidated Financial Statements](#bm_09f8a6cfc0088a40)\n\n9\n\n[Item 2.](#bm_fd6878b2e7f4d86e)\n\n[Management’s Discussion and Analysis of Financial Condition and Results of Operations](#bm_fd6878b2e7f4d86e)\n\n22\n\n[Item 3.](#bm_31f8b9f4bcdaea0f)\n\n[Quantitative and Qualitative Disclosures About Market Risk](#bm_31f8b9f4bcdaea0f)\n\n26\n\n[Item 4.](#bm_1eeca98fe90218f8)\n\n[Controls and Procedures](#bm_1eeca98fe90218f8)\n\n26\n\n \n\n \n\n \n\n[PART II](#bm_a4ebb626d70b4300)\n\n[OTHER INFORMATION](#bm_a4ebb626d70b4300)\n\n27\n\n[Item 1.](#bm_a6008684b51bc54b)\n\n[Legal Proceedings](#bm_a6008684b51bc54b)\n\n27\n\n[Item 1A.](#bm_35ce2909949cf04a)\n\n[Risk Factors](#bm_35ce2909949cf04a)\n\n28\n\n[Item 2.](#bm_990143b321456cf0)\n\n[Unregistered Sales of Equity Securities and Use of Proceeds](#bm_990143b321456cf0)\n\n68\n\n[Item 3.](#bm_cb663c0f07e0408e)\n\n[Defaults upon Senior Securities](#bm_cb663c0f07e0408e)\n\n68\n\n[Item 4.](#bm_5147804f35d98c7a)\n\n[Mine Safety Disclosures](#bm_5147804f35d98c7a)\n\n68\n\n[Item 5.](#bm_b22cc412f09ecf66)\n\n[Other Information](#bm_b22cc412f09ecf66)\n\n68\n\n[Item 6](#bm_3051135a52908a1c).\n\n[Exhibits](#bm_3051135a52908a1c)\n\n69\n\n \n\n \n\n \n\n[SIGNATURES](#bm_06114ebbbd1dddc5)\n\n70\n\n \n\n1\n\nCAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS\n\n \n\nThis Quarterly Report on Form 10-Q, includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical fact contained in this Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “project,” “continue,” “potential,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, statements about:\n\n \n\n         our anticipated operating and financial performance, business plans, and prospects;\n\n \n\n         expectations for our products, including anticipated regulatory submissions, study completion, approvals, clinical trial results and other developing data that become available, potential market size, and potential reimbursement pathways;\n\n \n\n         the timing and likelihood of, and our ability to obtain and maintain, regulatory clearance of our Investigational New Drug (“IND”) applications for and regulatory approval of our product candidates;\n\n \n\n         our ability to successfully scale manufacturing operations in a manner that enables us to complete our clinical trials and if our product candidates are approved, to meet commercial demand;\n\n \n\n         our ability to create and maintain a pipeline of product candidates;\n\n \n\n         our ability to advance any product candidate into, and successfully complete clinical trials;\n\n \n\n         our ability to initiate and successfully maintain operations of our subsidiary in Australia, including with respect to studies of our products and product candidates;\n\n \n\n         the initiation, timing, design, progress and results of our clinical trials, and our research and development program;\n\n \n\n         the anticipated receipt of proceeds from our tranched financings, including our ability to meet closing conditions at each closing;\n\n \n\n         the success of the business, including future capital expenditures, expenses, synergies, economic performance, indebtedness, financial condition, losses, future prospects, and business strategies for the management, expansion and growth of the company’s operations, and other conditions to the successful synergies of the business combination;\n\n \n\n         the effect of unfavorable macroeconomic factors resulting from global economic conditions or geopolitical developments, including fluctuating interest rates and inflation and capital market disruptions, changes in governmental agencies, government shutdowns, international tariffs, trade protection measures, public health crises, economic sanctions and potential economic slowdowns or recessions, or similar events that could impact our business;\n\n \n\n         the impact of laws and regulations in the United States and foreign countries on various aspects of our operations, including our regulatory and clinical strategy; and\n\n \n\n         other risks and uncertainties, including those listed under the caption “Risk Factors.”\n\n \n\nAny forward-looking statements in this Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties, assumptions and other factors described under the “Risk Factors” section and elsewhere in this Form 10-Q, that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements.\n\n \n\nIn addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements as predictions of future events. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.\n\n \n\nThis Form 10-Q also contains estimates, projections and other information concerning our industry, our business, and the markets for certain diseases, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources.\n\n \n\n2\n\nSUMMARY OF RISK FACTORS\n\n \n\nOur business is subject to a number of risks of which you should be aware before making an investment decision. These risks are discussed more fully in the “Risk Factors” section of this Form 10-Q. These risks include, but are not limited to, the following:\n\n \n\n         We are a clinical-stage company with a limited operating history, and have no products approved for commercial sale.\n\n \n\n         We are dependent on the successful design, development, regulatory approval and commercialization of one or more product candidates; there can be no assurance we will achieve any of these objectives.\n\n \n\n         Final marketing approval of NPM-139, NPM-133, NPM-115 or any of our other product candidates by the U.S. Food and Drug Administration (“FDA”) or other regulatory authorities may be delayed, limited, or denied, any of which would adversely affect our ability to generate operating revenues.\n\n \n\n         We will require substantial additional financing to pursue our business objectives, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations.\n\n \n\n         Clinical development involves a lengthy and expensive process with uncertain outcomes. We may incur additional costs and experience delays in developing our product candidates, and our clinical development efforts may not yield favorable results.\n\n \n\n         The commercial success of our product candidates, if approved, depends upon their market acceptance among physicians, patients, healthcare payors, and the medical community.\n\n \n\n         We are subject to a multitude of complex manufacturing challenges and risks, including reliance on third parties, any of which could substantially increase its costs and limit supply of our product candidates.\n\n \n\n         We may not be able to adequately protect our proprietary or licensed technology.\n\n \n\n         We may infringe the intellectual property rights of others, which may prevent or delay our development efforts and prevent us from commercializing or increase the costs of commercializing our product candidates, if approved.\n\n \n\n         We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.\n\n \n\n3\n\n[PART I. FINANCIAL STATEMENTS](#TOC)"}