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. In parallel, Vivani’s management team remains committed to identifying and exploring strategic options that will enable further development of its pioneering neurostimulation systems from legacy company Second Sight which are aimed at helping patients recover critical body functions. As noted below, we subsequently contributed our Second Sight assets and certain liabilities to Cortigent, Inc. (“Cortigent”), our wholly owned subsidiary to advance our pioneering neurostimulation technology.

Preclinical and NanoPortal™ Platform Development

In February 2024, Vivani announced positive preclinical weight loss data with its exenatide implant, NPM-115, that was comparable to semaglutide, the active ingredient in Ozempic® and Wegovy®, and a strategic shift to prioritize the Company's obesity portfolio. In a study of high-fat diet-induced obese mice, the exenatide implant generated weight loss of approximately 20% compared to a sham implant control after a 28-day treatment duration, comparable to the extent of weight loss observed in mice treated with semaglutide injections in the same study.

In February 2024, the Company also disclosed that semaglutide, the active ingredient in Ozempic®, Wegovy® and Rybelsus®, is the active pharmaceutical ingredient in NPM-139, another miniature, ultra long-acting subdermal GLP-1 implant in development for chronic weight management, further prioritizing our obesity treatment portfolio. NPM-139 has the added potential benefit of once-yearly administration.

On May 28, 2024, Vivani announced the publication of positive weight loss data supporting the potential veterinary use of OKV-119, the Company's miniature, ultra long-acting GLP-1 implant under development with partner Okava for the treatment of pre-diabetes, diabetes and obesity in companion felines. The device is intended to be conveniently inserted under the skin during routine veterinary visits and is being designed to deliver six months of GLP-1 therapy with a single administration.

On September 4, 2024, Vivani announced positive preclinical liver fat results with its miniature, ultra long-acting GLP-1 (exenatide) implant, NPM-115, under development for chronic weight management in obese and overweight individuals. The implant produced sham-implant adjusted liver fat reduction of 82% at Week 12 in an obese mouse model from a single administration with expected twice-yearly dosing. These liver fat data are consistent with published results from similar investigations with semaglutide.

On August 5, 2025, Vivani announced positive weight loss data from an ongoing preclinical study of NPM-139, an ultra long-acting subdermal GLP-1 (semaglutide) implant in development for chronic weight management, in rats, which showed approximately 20% sham-controlled weight loss, maintained for longer than 6 months after administration of a single implant. The Company also announced the successful completion of LIBERATE-1, the first-in-human application of Vivani’s NanoPortalTM implant technology, which showed a positive safety and tolerability profile, along with encouraging performance data. Based on the promising preclinical feasibility of the semaglutide implant and the successful completion of LIBERATE-1, Vivani announced its intention to focus our resources and prioritize efforts to accelerate NPM-139 into clinical-stage development.

Clinical Development

On July 14, 2023, we filed an Investigational New Drug Application (“IND”) for NPM-119 (exenatide implant) with the U.S. Food and Drug Administration (the “FDA”) to support the initiation of a first-in-human study of our GLP-1 implant in patients with type 2 diabetes. On August 18, 2023, FDA provided written notification that the study was on full clinical hold, primarily due to insufficient Chemistry, Manufacturing, and Controls (“CMC”) information to assess the risk to human subjects.

On June 13, 2024, Vivani announced that the FDA cleared the IND and lifted the clinical hold for NPM-119, the Company's miniature, six-month GLP-1 implant proposed for development for the treatment of patients with type 2 diabetes.

On July 11, 2024, the Company provided an update of the clinical development plans for NPM-115, the clinical program associated with the miniature, ultra long-acting GLP-1 (high-dose exenatide) implant for chronic weight management in obese and overweight individuals. The Company redesigned the first-in-human study, LIBERATE-1™, initially intended to explore the safety, tolerability and pharmacokinetics of NPM-119, its low-dose exenatide implant in patients with type 2 diabetes, to instead evaluate NPM-115, its high dose exenatide implant in obese and overweight individuals.

On September 26, 2024, the Company reported receiving regulatory approval to initiate its first-in-human clinical trial with NPM-115, a miniature, ultra long-acting GLP-1 (exenatide) implant in obese and overweight individuals in Australia. This clinical trial, known as LIBERATE-1, investigated the safety, tolerability and full pharmacokinetic profile of our exenatide implant. The trial also represented the first clinical application of the Company’s proprietary NanoPortal drug implant technology. LIBERATE-1 was redesigned to enroll participants who were titrated on weekly semaglutide injections for 8 weeks (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4 weeks) before being randomized to receive a single administration of Vivani’s exenatide implant (n=8), weekly exenatide injections (n=8), or weekly 1 mg semaglutide injections (n=8) for a 9-week treatment duration. The trial was initiated at the end of 2024 and top-line data was released in August 2025.

On December 19, 2024, Vivani announced that screening and enrollment of LIBERATE-1, the first-in-human clinical trial with a GLP-1 implant in obese and overweight patients, was initiated at two study centers in Australia. The primary objective of the study was to investigate the safety, tolerability and full pharmacokinetic profile of an exenatide implant in obese or overweight individuals.

On March 13, 2025, the Company announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial. This milestone marked a critical step toward potentially addressing one of healthcare’s most pressing challenges: medication adherence in metabolic diseases including chronic weight management and type 2 diabetes. The Company also announced full enrollment in the LIBERATE-1 study, which was achieved in just four weeks after enrollment of the first subject, signaling early potential interest for this six-month, subdermal GLP-1 implant.

Cortigent, Inc.

In December 2022, we contributed our neurostimulation assets and certain liabilities from legacy company Second Sight to Cortigent, our wholly owned subsidiary, to advance our pioneering neurostimulation technology. Cortigent had 5,000,000 shares of common stock outstanding, all owned by Vivani. On March 21, 2023, Vivani announced a proposed initial public offering ("IPO") to be registered on a Form S-1 registration statement for Cortigent to fund its operations separately from Vivani’s.

On August 25, 2023, the Company and Cortigent entered into an Amendment No. 1 (the “Amendment”) to the Transition Funding, Support and Services Agreement dated March 19, 2023 (the “TFSSA”). Pursuant to the TFSSA, Vivani agreed to advance funds and provide or cause to be provided to Cortigent the services and funding intended to cover salaries and related costs, rent and other overhead in order to permit Cortigent to operate in substantially the same manner as Second Sight prior to the formation of Cortigent. Efforts to support a successful IPO of Cortigent were paused in March 2025 and efforts were focused at that time on a potential spin-off transaction with the filing of a Form 10 registration statement. On March 12, 2025, the Company announced the proposed spin-off of Cortigent into a fully independent, publicly traded company, subject to the satisfaction of certain conditions, including, among others, final approval of Vivani’s board of directors, receipt of a favorable opinion that the transaction will qualify for non-recognition of gain or loss as a result of receipt of Cortigent shares for U.S. Federal Income Tax purposes, and SEC and Nasdaq approval. The TFSSA terminated effective December 31, 2024. Vivani continues to pursue a path forward to unlock stockholder value associated with this asset. If Cortigent is spun off through a Form 10 registration statement, the loan payable from Cortigent to Vivani will be forgiven.  A Form 10 registration statement was filed with the U.S. Securities and Exchange Commission (“SEC”) on May 29, 2025.

On September 17, 2025, Vivani announced that its board of directors had set a record date for the approved spin-off of Cortigent. Vivani's stockholders holding common stock as of that record date would receive common stock in Cortigent. This record date was withdrawn on October 3, 2025, due to delays arising from the shutdown of the U.S. federal government. Thereafter, Cortigent filed amendments to its registration statement on Form S-1 on December 2, 2025 and January 9, 2026. If Cortigent successfully completes an IPO, it will repay to Vivani $1.5 million of transition funding from the proceeds of that offering and issue a five-year promissory note requiring repayment of $2 million at five percent per year upon maturity of the promissory note.

Currently, both a spin-off to be registered on a Form 10 and an IPO to be registered on a Form S-1 registration statement are approaches being considered to transition Cortigent to becoming a separate reporting company that may provide an opportunity for Vivani's stockholders to potentially realize value in Cortigent’s assets. In the IPO scenario, Vivani would retain an ownership stake in Cortigent. In the Form 10 spin-off scenario, shares of Cortigent’s common stock would be distributed to the holders of Vivani's common stock. The strategic goal of either transaction is to create two focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise.

 Okava Pharmaceuticals, Inc.

On April 12, 2025, Vivani entered into an amendment to its License and Supply Agreement with Okava which expanded Vivani's ongoing collaboration to include dogs in the development of OKV-119, a long-acting GLP-1 therapy for weight management, type 2 diabetes, and other cardiometabolic conditions. The amendment added $5M in regulatory milestone payments related to the development of products for the treatment of obesity in dogs.

Liquidity and Capital Resources

From inception, our operations have been funded primarily through the sales of our common stock and warrants.

Our 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. We are subject to the risks and uncertainties associated with a business with no revenue that is developing novel medical devices, 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 support our future operations, the Company entered into three private equity purchase agreements in March 2025, May 2025 and August 2025. These agreements will bring an additional $12.6 million of committed capital into the Company between December 31, 2025 and July 15, 2026. Additionally, on January 25, 2026, the Company entered into a share purchase agreement with an entity affiliated with one of its independent directors for the purchase of an aggregate of 1,351,351 shares of common stock of the Company at a purchase price of $1.48 per share, the last reported sale price of the common stock on January 23, 2026. This private placement of common stock resulted in gross proceeds of approximately $2.0 million to the Company. Concurrent with the private placement, the Company also entered into a Placement Agency Agreement with ThinkEquity, LLC relating to the sale by the Company of 1,689,200 shares of the Company’s common stock in a registered direct offering, also at a purchase price of $1.48 per share. The gross proceeds from the Registered Offering were approximately $2.5 million, before placement agent fees and other estimated offering expenses. For additional information, refer to Note 15 Subsequent Event.

We estimate that currently available cash will provide sufficient funds to enable the Company to meet its planned obligations for at least the next twelve months. Our ability to continue as a going concern is dependent on our ability to develop profitable operations through implementation of our business initiatives and/or raise additional capital, however, there can be no assurances that we will be able to do so.