Organization and Business Operations	9 Months Ended
Sep. 30, 2026
Organization and Business Operations
Organization and Business Operations	Note 1. Organization and Business Operations Vivani Medical, Inc. (“Vivani,” the “Company,” “we,” “us,” “our” or similar terms) is a clinical-stage biopharmaceutical company that develops miniature, ultra long-acting subdermal drug implant candidates utilizing its proprietary NanoPortal™ technology, which is designed to enable reversible, ultra long-acting, near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop, and potentially commercialize, drug implant candidates, alone or in collaboration with pharmaceutical company partners, to address leading causes of poor clinical outcomes in the treatment of chronic diseases, including medication non-adherence, drug tolerability and administration challenges faced by certain patients. Vivani resulted from the business combination of Second Sight Medical Products, Inc. (“Second Sight”) and Nano Precision Medical, Inc. (“NPM”). On August 30, 2022, Second Sight and NPM completed their merger pursuant to which NPM became a wholly owned subsidiary of Second Sight and the combined company of NPM and Second Sight was renamed Vivani Medical, Inc. Vivani’s main priority is the further development of its miniature, ultra long-acting drug implant candidate programs. In parallel, Vivani’s management team remains committed to enabling further development of its pioneering neurostimulation systems from legacy company Second Sight which are aimed at helping patients recover critical body functions. Vivani subsequently contributed its Second Sight assets and certain liabilities to Cortigent, Inc. (“Cortigent”), its wholly owned subsidiary to advance its pioneering neurostimulation technology. On July 1, 2026, the Company entered into a merger agreement between Cortigent and a wholly-owned subsidiary of Nasdaq-listed ClearOne, Inc. (Nasdaq: CLRO). In connection with that transaction, ClearOne is pursuing a financing which aims to raise $10 million to $15 million concurrently with the merger’s closing. Liquidity, Capital Resources and Going Concern Our condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business, and which assumes timely execution for certain of management’s plans including the transition of Cortigent to becoming a separate reporting company by the end of the fourth quarter of 2026. From inception, our operations have been funded primarily through the sales of our common stock and warrants. We are subject to the risks and uncertainties associated with a business that does not generate revenue and that is developing novel biopharmaceutical products, including limitations on our operating capital resources. We have incurred recurring operating losses and negative operating cash flows since inception, and we expect to continue to incur operating losses and negative operating cash flows for the foreseeable future. To address these conditions, in March 2025, May 2025, and August 2025, we entered into three equity purchase agreements providing for up to $21.2 million of aggregate gross proceeds through 19 tranche closings occurring from August 13, 2025, through July 15, 2026. The final tranche closed on July 15, 2026 and no further proceeds are available under these agreements. For additional information, refer to Note 7, Equity Securities, of the Notes to Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q. We estimate that our existing cash and cash equivalents will be sufficient to fund our currently planned operations only through the first quarter of 2027. Accordingly, we will require additional capital to fund our operations beyond that period. Our plans include completing the transition of Cortigent to becoming a separate reporting company by the end of the fourth quarter of 2026 and obtaining additional financing. However, there can be no assurance that the transition will be completed within the anticipated timeframe or that additional financing will be available when needed or on acceptable terms. If we are unable to complete the transition or obtain sufficient additional funding, we would need to discontinue Cortigent’s operations to preserve our available liquidity. Our recurring operating losses and negative operating cash flows, together with our existing liquidity and need for additional capital to fund operations beyond the first quarter of 2027, raise substantial doubt about our ability to continue as a going concern for one year after the date these condensed consolidated financial statements are issued. Management’s plans described above do not alleviate this substantial doubt.

Organization and Business Operations

9 Months Ended

Sep. 30, 2026

Organization and Business Operations

Note 1. Organization and Business Operations

Vivani Medical, Inc. (“Vivani,” the “Company,” “we,” “us,” “our” or similar terms) is a clinical-stage biopharmaceutical company that develops miniature, ultra long-acting subdermal drug implant candidates utilizing its proprietary NanoPortal™ technology, which is designed to enable reversible, ultra long-acting, near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop, and potentially commercialize, drug implant candidates, alone or in collaboration with pharmaceutical company partners, to address leading causes of poor clinical outcomes in the treatment of chronic diseases, including medication non-adherence, drug tolerability and administration challenges faced by certain patients.

Vivani resulted from the business combination of Second Sight Medical Products, Inc. (“Second Sight”) and Nano Precision Medical, Inc. (“NPM”). On August 30, 2022, Second Sight and NPM completed their merger pursuant to which NPM became a wholly owned subsidiary of Second Sight and the combined company of NPM and Second Sight was renamed Vivani Medical, Inc. Vivani’s main priority is the further development of its miniature, ultra long-acting drug implant candidate programs. In parallel, Vivani’s management team remains committed to enabling further development of its pioneering neurostimulation systems from legacy company Second Sight which are aimed at helping patients recover critical body functions. Vivani subsequently contributed its Second Sight assets and certain liabilities to Cortigent, Inc. (“Cortigent”), its wholly owned subsidiary to advance its pioneering neurostimulation technology.

On July 1, 2026, the Company entered into a merger agreement between Cortigent and a wholly-owned subsidiary of Nasdaq-listed ClearOne, Inc. (Nasdaq: CLRO). In connection with that transaction, ClearOne is pursuing a financing which aims to raise $10 million to $15 million concurrently with the merger’s closing.

Liquidity, Capital Resources and Going Concern

Our condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business, and which assumes timely execution for certain of management’s plans including the transition of Cortigent to becoming a separate reporting company by the end of the fourth quarter of 2026.

From inception, our operations have been funded primarily through the sales of our common stock and warrants. We are subject to the risks and uncertainties associated with a business that does not generate revenue and that is developing novel biopharmaceutical products, including limitations on our operating capital resources. We have incurred recurring operating losses and negative operating cash flows since inception, and we expect to continue to incur operating losses and negative operating cash flows for the foreseeable future.

To address these conditions, in March 2025, May 2025, and August 2025, we entered into three equity purchase agreements providing for up to $21.2 million of aggregate gross proceeds through 19 tranche closings occurring from August 13, 2025, through July 15, 2026. The final tranche closed on July 15, 2026 and no further proceeds are available under these agreements. For additional information, refer to Note 7, Equity Securities, of the Notes to Condensed Consolidated Financial Statements in this Quarterly Report on Form 10-Q.

We estimate that our existing cash and cash equivalents will be sufficient to fund our currently planned operations only through the first quarter of 2027. Accordingly, we will require additional capital to fund our operations beyond that period. Our plans include completing the transition of Cortigent to becoming a separate reporting company by the end of the fourth quarter of 2026 and obtaining additional financing. However, there can be no assurance that the transition will be completed within the anticipated timeframe or that additional financing will be available when needed or on acceptable terms. If we are unable to complete the transition or obtain sufficient additional funding, we would need to discontinue Cortigent’s operations to preserve our available liquidity.

Our recurring operating losses and negative operating cash flows, together with our existing liquidity and need for additional capital to fund operations beyond the first quarter of 2027, raise substantial doubt about our ability to continue as a going concern for one year after the date these condensed consolidated financial statements are issued. Management’s plans described above do not alleviate this substantial doubt.