Note 1. Organization and Business Operations

Vivani Medical, Inc. (“Vivani” or the “Company” 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. The Company entered into a merger agreement between Cortigent and a wholly-owned subsidiary of Nasdaq-listed ClearOne, Inc. (Nasdaq: CLRO) dated July 1, 2026. 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

Since inception, we have funded our operations primarily through sales of our common stock and warrants. We are not a revenue-generating organization, and we have incurred recurring operating losses and negative operating cash flows since inception. We expect to continue to incur operating losses and negative operating cash flows for the foreseeable future. As a company that does not generate revenue and that develops novel biopharmaceutical products, we are subject to the risks and uncertainties associated with such a business, including limitations on our operating capital resources. We estimate that our existing cash and cash equivalents will be sufficient to fund our currently planned operations only through the second quarter of 2027, which is before the end of the one‑year evaluation period described below, and we will require additional capital to continue operating thereafter.

These conditions and events raise substantial doubt about our ability to continue as a going concern within one year after the date these condensed consolidated financial statements are issued.

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 as of that date all shares issuable under these agreements had been issued, with no further proceeds available thereunder. 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.

Management's plans to fund operations beyond the second quarter of 2027 include transitioning Cortigent to a separate reporting company by the end of the third quarter of 2026 and raising additional capital. If the Cortigent transition is not completed in the third quarter of 2026 and we are unable to secure additional funding, we would need to discontinue Cortigent's operations to preserve liquidity through the second quarter of 2027. There can be no assurance that we will complete the Cortigent transition or that additional financing will be available to us on acceptable terms, or at all.

Because these plans are not fully within our control and their successful execution cannot be considered certain, management has concluded that its plans do not alleviate the substantial doubt about our ability to continue as a going concern. The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern and do not include any adjustments to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty.