Business Description

1. Organization and Business Operations Vivani Medical, Inc. (“Vivani,” the “Company,” “we,” “us,” “our” or similar terms) is a clinical stage biopharmaceutical company which 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. According to the U.S. Centers for Disease Control and Prevention, adherence is defined as the extent to which an individual’s behavior, including taking medications, corresponds to recommendations from a health care provider. An alarmingly high proportion of patients, approximately 50 %, do not, or cannot, take their medicine as prescribed in the real world, a statistic that applies to both daily oral as well as weekly injectable medicines. For example, a recent study has shown that 64 % of patients taking Wegovy® ( semaglutide injection ) discontinue treatment within the first year, a number that increases to 76 % by the second year. Unfortunately, GLP- 1 discontinuation may result in failure to achieve target outcomes and a quick reversal of the health benefits in the majority of patients. At Vivani, we are developing a portfolio of miniature, ultra long-acting subdermal drug implant candidates based on our NanoPortal technology that, unlike most oral and injectable medicines, are designed with the goal of guaranteeing medication adherence by delivering therapeutic drug levels for up to six months or longer. Our NanoPortal implant technology has the potential to enable patients to maintain continuous and therapeutic drug exposure levels with convenient once or twice yearly administration and the ability to stop receiving therapy at any time, if necessary, by removing the implant . In addition, we aim to minimize fluctuations in patients’ drug levels which may improve the tolerability of medicines, including GLP- 1 receptor agonists which produce side effects that are associated with fluctuating drug levels in the blood. Our emerging portfolio of miniature, ultra long-acting drug implant candidates have the potential to revolutionize the treatment of chronic diseases by directly addressing poor medication adherence and improving drug tolerability in patients, both of which may translate into better health outcomes for patients in the real-world setting. Vivani's lead program, NPM- 139 , is a miniature, six -month, GLP- 1 (semaglutide) implant currently in development for chronic weight management in obese and overweight patients. NPM- 139 achieved encouraging preclinical data in rats showing approximately 20 % weight loss, as compared to a control group receiving sham implants, which was maintained for a full year after a single administration. We are also developing NPM- 133 , a miniature, six -month, GLP- 1 (semaglutide) implant for the treatment of type- 2 diabetes. Preliminary feasibility data support the additional potential benefit of once yearly dosing for both semaglutide implant programs, NPM- 139 and NPM- 133 . In addition, we are also developing NPM- 115 (exenatide implant) for the treatment of chronic weight management, and OKV- 119 , a GLP- 1 -based implant in development for chronic weight management and related conditions in companion cats and dogs. OKV- 119 is being developed in collaboration with animal health partner Okava Pharmaceuticals, Inc. ( “ Okava ” ). 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.…