Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. The consolidated results of operations for the years ended December 31, 2024 and 2023 are not necessarily indicative of the results that may be expected for any future period. The following discussion should be read in conjunction with the consolidated financial statements and the notes thereto included in Part IV, Item 15 of this Form 10-K and in conjunction with the “Risk Factors” included in Part I, Item 1A of this Form 10-K.

Business Overview

Vivani Medical, Inc. (“Vivani,” the “Company,” “we,” “us,” “our” or similar terms) is a clinical stage biopharmaceutical company which develops miniaturized, subdermal drug implants utilizing its proprietary NanoPortalTM technology, which is designed to enable 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 a leading cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence. 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 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 therapy within the first year of treatment, a number that increases to 76% by the second year. Unfortunately, GLP-1 discontinuation may result in a quick reversal of the health benefits in the majority of patients.

AtVivani, we are developing a portfolio of miniature, subdermal drug implant candidates 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. In addition, our aim is to minimize fluctuations in patients’ drug levels through the use of ourNanoPortaltechnology, which may improve the tolerability profiles for medicines, including GLP-1 receptor agonists, that produce side effects associated with fluctuating drug levels in the blood.

Our emerging portfolio of miniature, ultra long-acting drug implants have the potential to revolutionize the treatment of chronic diseases by directly addressing poor medication adherence and improving patient tolerability to their treatments which has the potential to translate into better health outcomes for patients in the real-world setting. Vivani's lead program, NPM-115, is a miniature, six-month, GLP-1 (high-dose exenatide) implant currently in clinical-stage testing for chronic weight management in obese and overweight individuals. Other programs include, NPM-139 (semaglutide implant) also in development for chronic weight management, NPM-119 (exenatide implant) in development for the treatment of type 2 diabetes and OKV-119, another GLP-1 based implant in development for the treatment of cardiometabolic disorders in cats and dogs in collaboration with animal health partner 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 lead program NPM-115, a miniature, 6-month, GLP-1 implant candidate for chronic weight management in obese or overweight patients with one or more risk factors and further development of the balance of the company’s miniature, ultra long-acting drug implant portfolio. 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 aimed at helping patients recover critical body functions.

In December 2022, we contributed our neurostimulation assets from legacy company Second Sight and certain liabilities to Cortigent, Inc. (“Cortigent”), a wholly owned subsidiary of Vivani to advance the Company’s pioneering neurostimulation technology. Cortigent has 5,000,000 shares of common stock outstanding, all owned by Vivani. In March 2023, Vivani announced the filing of a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (“SEC”) for the proposed initial public offering of Cortigent. In March 2025, Vivani announced a change in strategy to discontinue efforts to pursue a proposed initial public offering and shift focus to file a Form 10 with the SEC to support the spin-off of Cortigent into a fully independent, publicly traded company. The strategic goal of this transaction is to create two focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise. If the spinoff is successful, the loan payable from Cortigent to Vivani would be forgiven.

On July 6, 2023,Vivanichanged its state of incorporation from the State of California to the State of Delaware by means of a plan of conversion, effective July 5, 2023. The reincorporation, including the principal terms of the plan of conversion, was submitted to a vote of, and approved by,Vivani’sstockholders at its 2023 Annual Meeting of Stockholders held on June 15, 2023. As part of this change of incorporation the Company established a par value of $0.0001 per share and all periods have been retroactively adjusted to reflect this change.

An IND for NPM-119 (GLP-1 implant) was filed with FDA on July 14, 2023, to support the initiation of a first-in-human study of an exenatideimplant 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. After providing additional information to sufficiently address theFDA'srequests, the FDA lifted the clinical hold on NPM-119 on June 13, 2024 allowing for the proposed study to proceed. The primary objective of this first-in-human clinical study was to evaluate the safety, tolerability and pharmacokinetics of NPM-119 in type 2 diabetes patients. The initial study design also incorporatedBydureonBCise® (exenatideinjection) for comparison purposes.

On August 25, 2023, the Company and Cortigent entered into an Amendment 1 (the “Amendment”) to the Transition Funding, Support and Services Agreement dated March 19, 2023 (the “TFSSA”). Pursuant to the TFSSA, Vivani has 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 in which business operations of Cortigent were previously operated by Second Sight, prior to the formation of Cortigent, which obligations will continue, in the case of the funding obligations, at the discretion of Vivani or after the closing of an initial public offering of Cortigent. If an initial public offering of Cortigent closes, Cortigent has agreed to repay $1,500,000 to Vivani and enter into a five-year promissory note at 5% interest for $2,000,000 in favor of Vivani. Consequently, Vivani will forgive any remaining amounts due by Cortigent. Efforts to support a successful initial public

offering of Cortigent ceased in March 2025 and efforts are now focused on

a potential spinoff with the filing of a Form 10 registration statement. The TFSSA terminated effective December 31, 2024.

In the fourth quarter of 2023, Vivani Medical Australia Pty Ltd., a wholly owned subsidiary in Australia was established to support studies of our product candidates.

In February 2024, Vivani announced positive preclinical weight loss data with its exenatide implant that was comparable to semaglutide, the active ingredient in Ozempic®/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, the Company also disclosed that semaglutide is the active pharmaceutical ingredient in NPM-139, another miniature, long term subdermal GLP-1 implant in development for chronic weight management further demonstrating our prioritization on obesity. NPM-139 also has the added potential benefit of once-yearly administration.

On March 1, 2024, the Company entered into a securities purchase agreement (“Securities Purchase Agreement”) with an institutional investor to purchase 3,947,368 shares of common stock, par value $0.0001 per share (the “Common Stock”) and warrants to purchase up to an aggregate of 3,947,368 shares of common stock at a purchase price of $3.80 per share and accompanying warrant in a registered direct offering (the “Offering”). The warrants have an exercise price of $3.80 per share, are exercisable immediately upon issuance, and will expire three years following the date of issuance.

On April 22, 2024, the Company entered into an Open Market Sale AgreementSM(the “Sales Agreement”) with Jefferies LLC (“Jefferies”), under which the Company may offer and sell, from time to time at its sole discretion, shares of the common stock, having an aggregate offering price of up to $75.0 million through Jefferies as its sales agent. Also on April 22, 2024, the Company filed a Registration Statement on Form S-3, which was declared effective on May 3, 2024, including a sales agreement prospectus relating to the offering of up to $75.0 million shares of its common stock in accordance with the Sales Agreement.

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, 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.

As stated previously, 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 under 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, long-acting GLP-1 (high-dose exenatide) implant for chronic weight management in obese and overweight individuals. The Company has redesigned the first-in-human study, LIBERATE-1TM, initially intended to explore the safety, tolerability and pharmacokinetics of its exenatide implant in patients with type 2 diabetes, to evaluate the implant in obese and overweight patients.

On September 4, 2024, Vivani announced positive preclinical liver fat results with its miniature, ultra long-acting GLP-1 implant currently under development for chronic weight management in obese and overweight individuals and type 2 diabetes. The Company's GLP-1 (exenatide) implant produced sham-implant adjusted liver fat reduction of 82% 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, the active pharmaceutical ingredient in Ozempic and Wegovy.

On September 26, 2024, the Company reported receiving regulatory approval to initiate its first-in-human clinical trial with a miniature, ultra long-acting GLP-1 (exenatide) implant in obese and overweight individuals in Australia. This clinical trial, known as LIBERATE-1, is part of the NPM-115 program and will investigate the safety, tolerability and full pharmacokinetic profile of an exenatide implant. The trial also represents the first clinical application of the Company’s proprietary NanoPortal drug implant technology. LIBERATE-1 was redesigned to enroll participants who will be 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. Changes in weight will be measured. The trial was initiated at the end of 2024 with data projected to be available in mid-2025.

On November 8, 2024, the Company entered into a private sale transaction with one of its independent directors whereby the Company sold an aggregate of 3,968,253 shares of the Company’s common stock to the director at a price of $1.26 per share, which was the lower of the closing price of the Company’s common stock on the Nasdaq or the 5-day average closing price of the Company’s common stock on the Nasdaq, each immediately prior to the closing date, subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions of the common stock that occur after the date of the private sale transaction. The gross proceeds from this private sale transaction were $5.0 million.

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 is to investigate the safety, tolerability and full pharmacokinetic profile of an exenatide implant in obese or overweight individuals. Consistent with previous guidance, study results are anticipated to be reported in mid-2025.

On March 13, 2025, Vivani announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial. This milestone marks a critical step toward 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 and reaffirming previous estimates that top-line results should be available in mid-2025.

On March 26, 2025, the

Company entered into a private sale transaction with an entity affiliated with

one of its independent directors whereby

the Company shall sell an aggregate of 7,366,071 shares of the Company’s common

stock to the entity, in one or more closings as provided in the purchase

agreement, at a price of $1.12 per share, which was the closing price of the

Company’s common stock on the Nasdaq, subject to adjustment for reverse and

forward stock splits, stock dividends, stock combinations and other similar

transactions of the common stock that occur after the date of the private sale transaction.

The gross proceeds from this private sale transaction will be approximately

$8.25 million.

Funding and Liquidity

Capital Funding

From inception, our operations have been funded primarily through the

sales of our common stock and warrants.

On March 1, 2024, the Company entered

into the Securities Purchase Agreement relating to the issuance of 3,947,368 shares of the Company’s common stock, Common Stock and warrants to purchase up to an aggregate of 3,947,368

shares of common stock (the “Warrants”), to such investor at a purchase price

of $3.80 per share and accompanying warrants in a

registered direct offering (the “Offering”). The Warrants have an exercise

price of $3.80 per share, are exercisable

immediately upon issuance and will expire three

years following the date of issuance. Simultaneously, the Company also entered

into a placement agency agreement with Maxim Group LLC (“Maxim” and such

agreement, the “Placement Agency Agreement,” and together with the Securities

Purchase Agreement, the “Agreements”), who acted as the sole placement agent

for the Offering. The gross proceeds of $15.0

million from the Offering, before paying the placement agent fees and other

offering costs, were received on March 5, 2024. In connection with the

Securities Purchase Agreement, the Company paid issuance costs of $1.3 million, resulting in net proceeds of $13.7 million. For additional information, refer to Note

7. Equity Securities of the Notes to Condensed

Consolidated Financial Statements in this Annual Report on Form 10-K.

On April 22, 2024, the Company entered into an Open

Market Sale AgreementSM (the “Sales Agreement”) with Jefferies LLC

(“Jefferies”), under which the Company may offer and sell, from time to time at

its sole discretion, shares of the common stock, having an aggregate offering

price of up to $75.0 million through Jefferies as

its sales agent. Also on April 22, 2024, the Company filed a Registration

Statement on Form S-3, which was declared

effective on May 3, 2024, including a sales agreement prospectus relating to

the offering of up to $75.0 million shares of its

common stock in accordance with the Sales Agreement. For additional

information, refer to Note 7. Equity Securities

of the Notes to Condensed Consolidated Financial Statements.

During the twelve months ended December 31, 2024, the Company issued 287,970 shares of common stock for gross proceeds of $504,000 as

part of the Sales Agreement with Jefferies. The Company paid expenses of

$344,000, resulting in net proceeds of $160,000.

On November

8, 2024, the Company entered into a private sale transaction with one of its independent directors whereby the Company

sold an aggregate of 3,968,253 shares of the

Company’s common stock to the director at a price of $1.26

per share, which was the lower of the closing price of the Company’s common

stock on the Nasdaq or the 5-day average closing

price of the Company’s common stock on the Nasdaq, each immediately prior to

the closing date, subject to adjustment for reverse and forward stock splits,

stock dividends, stock combinations and other similar transactions of the

common stock that occur after the date of the private sale transaction. The

gross proceeds from this private sale transaction were $5.0 million.

On March 26, 2025, the

Company entered into a private sale transaction with an entity affiliated with

one of its independent directors whereby

the Company shall sell an aggregate of 7,366,071 shares of the Company’s common

stock to the entity, in one or more closings as provided in the purchase

agreement, at a price of $1.12 per share, which was the closing price of the

Company’s common stock on the Nasdaq, subject to adjustment for reverse and

forward stock splits, stock dividends, stock combinations and other similar

transactions of the common stock that occur after the date of the private sale transaction.

The gross proceeds from this private sale transaction will be approximately

$8.25 million.

Non-Capital Funding

From time to time, we receive grants that help fund specific development programs. Any amounts received pursuant to grants are offset against the related operating expenses as the costs are incurred. Commencing in January 2018, we were awarded a grant from the National Institutes of Health (the “NIH”) to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis”. The final year of the grant ended in March 2024, however the NIH issued us a no-cost extension allowing us to utilize the unfunded amount through March 2025. During theyears ended December 31, 2024and2023total grants offsetting against operating expenses were $0.2 million and $0.5 million, respectively. As ofDecember 31, 2024, we expect $35,000 will be available to offset future operating expenses.

Liquidity

We have experienced recurring operating losses and

negative operating cash flows since inception and have financed our working

capital requirements through the recurring sale of our equity securities. 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.

To finance our operations, we will need to raise

additional capital, which cannot be assured. Our operating plan may change as a

result of many factors currently unknown to us, and we will need to seek

additional funds through public or private equity offerings or debt financings,

grants, collaborations, strategic partnerships or other sources. However, we

may be unable to raise additional capital or enter into such other arrangements

when needed on favorable terms or at all. If we are unable to obtain funding on

a timely basis, we may be required to significantly curtail, delay or

discontinue one or more of our research or

development programs, or we may be unable to expand or maintain our operations,

maintain our current organization and employee base or otherwise capitalize on

our business opportunities, as desired, which could materially and adversely

affect our business, financial condition and results of operations.

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 raise additional capital and/or develop profitable

operations through implementation of our business initiatives, however, there

can be no assurances that we will be able to do so.

Recently Adopted Accounting Standards

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07, Improvements to Reportable Segment Disclosures (Topic 280). This ASU updates reportable segment disclosure requirements by requiring disclosures of significant reportable segment expenses that are regularly provided to the Chief Operating Decision Maker (“CODM”) and included within each reported measure of a segment’s profit or loss. This ASU also requires disclosure of the title and position of the individual identified as the CODM and an explanation of how the CODM uses the reported measures of a segment’s profit or loss in assessing segment performance and deciding how to allocate resources. The ASU is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Adoption of the ASU should be applied retrospectively to all prior periods presented in the financial statements. We adopted this ASU for the year ending December 31, 2024.

Critical Accounting Policies and Estimates

The following discussion and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in conformity with accounting principles generally accepted in the United States of America. Certain accounting policies and estimates are particularly important to the understanding of our financial position and results of operations and require the application of significant judgment by our management or can be materially affected by changes from period to period in economic factors or conditions that are outside of our control. As a result, they are subject to an inherent degree of uncertainty. In applying these policies, our management uses their judgment to determine the appropriate assumptions to be used in the determination of certain estimates. Those estimates are based on our historical operations, our future business plans and projected financial results, the terms of existing contracts, our observance of trends in the industry, information provided by our customers and information available from other outside sources, as appropriate. See Note 2 of notes to our consolidated financial statements for a more complete description of our significant accounting policies.

Stock-Based Compensation.Pursuant to Financial Accounting Standards Board ASC718,Share-BasedPayment (“ASC718”), we record stock-based compensation expense for all stock-based awards. Under ASC718, we estimate the fair value of stock options granted using option pricing models. The fair value for awards that are expected to vest is then amortized on a straight-line basis over the requisite service period of the award, which is generally the option vesting term. The Company accounts for forfeitures as they occur.

For stock options or restricted stock units with market vesting conditions, the awards were valued using the Monte-Carlo Simulation model.

Results of Operations

Operating Expenses. We recognize our operating expenses as incurred in two general operational categories: research and development and general and administrative. Our operating expenses also include a non-cash component related to the amortization of stock-based compensation for research and development and general and administrative personnel. From time-to-time we have received grants from institutions or agencies, such as the National Institutes of Health, to help fund some of the cost of our development efforts. We have recorded these grants as reductions to operating expenses.

Comparison of the Years Ended December 31, 2024 and 2023

Research and development expense. Research and development expense during the year ended December 31, 2024 was $15.7 million, compared to $17.0 million during the year ended December 31, 2023. The decrease of $1.2 million, or 7%, was primarily attributable to staffing reduction and reduced use of outside services from our Neurostimulation Division, partially offset by the increase in the clinical trial related expense from our Biopharm Division.

General and administrative expense. General and administrative expense during the year ended December 31, 2024 was $8.9 million, compared to $10.0 million during the year ended December 31, 2023. The decrease of $1.1 million, or 11%, was primarily attributable to staffing reductions along with reduced outside legal services from our Neurostimulation Division, partially offset by the increase in theprofessional services from our Biopharm Division.

Other income (expense), net. Other income (expense), net during the year ended December 31, 2024 was $1.2 million, compared to $1.3 million during the year ended December 31, 2023. The change was insignificant and relates to less interest being earned on deposits.

Net loss. The net loss during the year ended December 31, 2024 was $23.5 million, compared to $25.7 million during the year ended December 31, 2023. The decrease in net loss of $2.2 million was primarily attributable to staffing reduction and reduced use of outside services from our Neurostimulation Division, partially offset by increased clinical trial related expense and professional services from ourBiopharm Division.

Liquidity and Capital Resources

We have experienced recurring operating losses and negative operating cash flows since inception and have financed our working capital requirements through the recurring sale of our equity securities. Our financial statements have been presented on the basis that our business is a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

On March 1, 2024, the Company entered into the Securities Purchase Agreement relating to the issuance of 3,947,368 shares of the Company’s common stock, par value of $0.0001 per share and warrants to purchase up to an aggregate of 3,947,368 shares of common stock at a purchase price of $3.80 per share and accompanying warrants in a registered direct offering. The Warrants have an exercise price of $3.80 per share, are exercisable immediately upon issuance and will expire three years following the date of issuance. In connection with the Placement Agency Agreement, the Company agreed to pay Maxim an aggregate cash fee of 7.0% of the aggregate proceeds raised from the sale and issuance of the shares of common stock and accompanying warrants. Pursuant to the Placement Agency Agreement, the Company also agreed to reimburse Maxim up to $65,000 for its legal expenses. The gross proceeds of $15.0 million from the Offering, before paying the placement agent fees and other estimated offering costs, were received on March 5, 2024. In connection with the Securities Purchase Agreement, the Company paid issuance costs of $1.3 million, resulting in net proceeds of $13.7 million, during the year ended December 31, 2024. For additional information, refer to Note 7. Equity Securities of the Notes to Condensed Consolidated Financial Statements in this Annual Report on Form 10-K.

On April 22, 2024, the Company entered into the Sales Agreement with Jefferies, under which the Company may offer and sell, from time to time at its sole discretion, shares of the common stock, having an aggregate offering price of up to $75.0 million through Jefferies as its sales agent. Also on April 22, 2024, the Company filed a Registration Statement on Form S-3, which was declared effective on May 3, 2024, including a sales agreement prospectus relating to the offering of up to $75.0 million shares of its common stock in accordance with the Sales Agreement. For additional information, refer to Note 7. Equity Securities of the Notes to Condensed Consolidated Financial Statements. During the twelve months ended December 31, 2024, the Company received net proceeds of $160,000 from issuing common stocks under the Sales Agreement with Jefferies.

On November 8, 2024, the Company entered into a private sale transaction withoneof its independent directors whereby the Company sold an aggregate of3,968,253shares of the Company’s common stock to the director at a price of $1.26per share, which was the lower of the closing price of the Company’s common stock on theNasdaqor the5-day average closing price of the Company’s common stock on theNasdaq, each immediately prior to the closing date, subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions of the common stock that occur after the date of the private sale transaction. The gross proceeds from this private sale transaction were $5.0 million.

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.

We are subject to the risks and uncertainties associated with a business with no revenue that is developing a novel pharmaceutical product candidates and medical device candidates, including limitations on our operating capital resources and uncertain demand for our products. 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. We expect our operating expenses to increase significantly as we continue our business operations, particularly as we prepare to and initiate our planned clinical trial and conduct our other research and development activities. Conducting clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete and we may never generate the necessary data or results required to obtain marketing approval. We do not expect revenues until we are successful in completing the development and obtaining marketing approval for our products. We expect expenses to increase in connection with our ongoing activities, particularly as we initiate clinical trials, initiate new research and development projects and seek marketing approval for any product candidates that we successfully develop. If we are required to conduct additional nonclinical or clinical activities preclinical or IND-enabling activities such as additional pre-clinical, our overall expenditures would increase. In addition, if we obtain marketing approval, we expect to incur significant additional expenses related to sales, marketing, distribution and other commercial infrastructure to commercialize such product. In addition, our product candidates, if approved, may not achieve commercial success. We incur significant costs associated with operating as a public company in a regulated industry.

Until such time, if ever, we can generate product revenues, we anticipate that we will seek to fund our operations through public or private equity or debt financings, grants, collaborations, strategic partnerships or other sources. However, we may be unable to raise additional capital or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity, convertible debt or other equity-linked securities, the ownership interests of some or all of our common stockholders will be diluted, the holders of new equity securities may have priority rights over our existing stockholders and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If adequate funds are not available, we may be required to curtail operations significantly or to obtain funds by entering into agreements on unattractive terms. If, for example, we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us. Our inability to raise capital could have a material adverse effect on our business, financial condition and results of operations.

Cash, cash equivalents and restricted cash decreased by $2.3 million from $22.0 million as of December 31, 2023 to $19.7 million as of December 31, 2024. Working capital was $14.5 million as of December 31, 2024, as compared to $17.3 million as of December 31, 2023. We use our cash and cash equivalents and working capital to fund our operating activities.

Cash Flows from Operating Activities

During 2024, we used $20.8 million of cash in operating activities, consisting primarily of a net loss of $23.5 million, partially offset by $0.4 million from a net change in operating assets and liabilities, and non-cash items totaling $2.3 million for stock-based compensation, lease expense, depreciation and amortization of property and equipment, fixed assets write-off.

During 2023, we used $23.7 million of cash in operating activities, consisting primarily of a net loss of $25.7 million and $1.3 million used from a net change in operating assets and liabilities, partially offset by non-cash items totaling $3.2 million for depreciation and amortization of property and equipment, stock-based compensation, loss on disposal of fixed assets and lease expense.

Cash Flows from Investing Activities

Net cash used in investing activities during 2024 and 2023 was $0.6 million and $0.9 million, respectively, for the purchase of equipment.

Cash Flows from Financing Activities

In 2024, financing activities provided $19.1 million of cash primarily attributable to $13.7 million from a securities purchase agreement with an institutional investor and $5.0 million from another securities purchase agreement with one of our independent directors.

In 2023, financing activities provided $0.1 million of cash primarily from stock option exercises.

Off-Balance Sheet Arrangements

At December 31, 2024, we did not have any transactions, obligations or relationships that could be considered off-balance sheet arrangements.

Item 7A. Quantitative and Qualitative Disclosures about Market Risk

Interest Rate Sensitivity

The primary objective of our investment activities is to maintain the safety of principal and preserve liquidity without incurring significant risk. We invest cash in excess of our current needs in money market funds and short-term certificates of deposits (“CDs”). In general, money market funds are not considered to be subject to interest rate risk because the interest paid on such funds fluctuates with the prevailing interest rate. As of December 31, 2024 and 2023, our cash equivalents consisted money market funds deposited at Merrill Lynch, CDs at JPMorgan Chase bank, and restricted cash as collateral for our lease.

Exchange Rate Sensitivity

In 2024 and 2023, the majority of our operating expenses were denominated in U.S. dollars. We have not entered into foreign currency forward contracts to hedge our operating expense exposure to foreign currencies, but we may do so in the future.

Item 8. Financial Statements and Supplementary Data

Our financial statements and supplementary data required by this Item are provided in the consolidated financial statements included in this Form 10-K as listed in Item 15(a) of this Form 10-K.

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

None.

Item 9A. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Disclosure controls and procedures are designed to ensure that information required to be disclosed by us in reports filed or submitted under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in reports filed or submitted under the Exchange Act is accumulated and communicated to management, including our principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow for timely decisions regarding required disclosure. Due to inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Further, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that degree of compliance with the policies and procedures may deteriorate. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives.

As of December 31, 2024, management has concluded that our disclosure controls and procedures were effective based upon testing of our key internal controls. Our management, including our CEO and CFO, has concluded that the consolidated financial statements included in this Form 10-K fairly present, in all material respects, our financial position, results of operations and cash flows for the periods presented in this Form 10-K in conformity with GAAP.

This Form 10-K does not include an attestation report from our independent registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our independent registered public accounting firm pursuant to our non-accelerated filer status.

Management’s Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Our internal control over financial reporting includes those policies and procedures that:

1. Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets;

2. Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with the authorization of our management and directors; and

3. Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.

As of December 31, 2024, based on the criteria established in “Internal Control — Integrated Framework” (2013 Framework) issued by the Committee of Sponsoring Organizations of the Treadway Commission, management has completed written documentation of its internal control policies, procedures and controls and has completed its testing of its key controls. Based upon the results of this testing we have concluded that our internal control over financial reporting was effective as of the end of the period covered by this Form 10-K.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting that occurred during or subsequent to our fourth quarter of the year ended December 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

The design of any system of control is based upon certain assumptions about the likelihood of future events. There can be no assurance that any design will succeed in achieving its stated objectives under all future events, no matter how remote, or that the degree of compliance with the policies or procedures may not deteriorate. Because of its inherent limitations, disclosure controls and procedures may not prevent or detect all misstatements. Accordingly, even effective disclosure controls and procedures can provide only reasonable assurance of achieving their control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies and procedures may deteriorate.

Item 9B. Other Information

Rule 10b5-1 Trading Plan Disclosure.

On July 8, 2024, Lisa Porter, the Company’s Chief Medical Officer, entered into a 10b5-1 trading plan. Dr. Porter’s plan provides for the sale of up to 93,000 shares of the Company’s common stock. Sales of the shares of the Company’s common stock set forth in Dr. Porter’s trading plan, if any, will be made at or above specified market prices. The trading plan will expire on or before June 30, 2025. Dr. Porter’s trading plan was entered into during an open insider trading window and is intended to satisfy Rule 10b5-1(c) under the Exchange Act and the Company’s policies regarding insider transactions.

Apart from as disclosed above, no Rule 10b5-1 plans or non-Rule 10b5-1 trading arrangements were adopted, modified, or terminated by officers or directors of the Company, nor were there any material changes to the procedures by which security holders may recommend nominees to the Company’s Board of Directors, during the quarter ended December 31, 2024.

Item 9C. Disclosure regarding foreign jurisdictions that prevent inspections

Not Applicable.

PART III

Certain information required by Part III

is omitted from this Annual Report on Form 10-K and is incorporated by reference from our definitive proxy statement relating to

our 2025 annual meeting of stockholders, pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended, also referred

to in this Annual Report on Form 10-K as our 2025 Proxy Statement, which we will file with the SEC not later than 120 days after

the end of the fiscal year covered by this Annual Report on Form 10-K.

Item 10. Directors, Executive Officers and Corporate Governance

Information regarding our directors, including

the audit committee and audit committee financial experts, and executive officers, and compliance with Section 16(a) of the Exchange

Act will be included in an amendment to this Form 10-K or in our 2025 Proxy Statement and is incorporated herein by reference.

We have adopted a Code of Business Conduct

that applies to all officers, directors and employees in connection with their work for us. The full text of our Code of Business

Conduct is posted on the investors page of our website at https://investors.vivani.com/investors/corporate-governance/governance-documents.

We intend to satisfy any disclosure requirements

under Item 5.05 of Form 8-K regarding an amendment to, or waiver from, a provision of this Code of Business Conduct by posting

such information on our website, at the Internet address and location specified above.

The Company has adopted an insider trading policy that governs the purchase, sale, and/or other transactions of our securities by our directors, officers and employees. A copy of our insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K. In addition, with regard to the Company’s trading in its own securities, it is the Company’s policy to comply with the federal securities laws and the applicable exchange listing requirements.

There are no material changes to the procedures by which security holders may recommend nominees to the Company’s board of directors, during the quarter ended December 31, 2024.

Item 11. Executive Compensation

The information required by Item 402 and Item 407(e)(4) and (e)(5) of Regulation S-K will be included in the 2025 Proxy Statement and is incorporated herein by reference (excluding the information required by Item 402(v) of Regulation S-K relating to pay versus performance).

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

The information required by this item regarding security ownership of certain beneficial owners and management will be included in an amendment to this Form 10-K or in our 2025 Proxy Statement and is incorporated herein by reference.

Item 13. Certain Relationships and Related Transactions, and Director Independence

The information required by this item regarding certain relationships and related transactions and director independence will be included in an amendment to this Form 10-K or in our 2025 Proxy Statement and is incorporated herein by reference.

Item 14. Principal Accounting Fees and Services

The information required by this item regarding principal accounting fees and services will be included in an amendment to this Form 10-K or in our 2025 Proxy Statement and is incorporated herein by reference.

PART IV

Item 15. Exhibits, Financial Statement Schedules

(a) The following documents are included in this Annual Report on Form 10-K:

EXHIBIT INDEX

Exhibit No. Exhibit Description

19.1* Insider Trading Policy.

23.1* Consent of BPM LLP, Independent Registered Public Accounting Firm.

24.1 Power of Attorney (included in the signature page to this report).

101.INS Inline XBRL Instance Document

101.SCH Inline XBRL Taxonomy Extension Schema Document

101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document

* Filed herein.

+ Indicates management contract or compensatory plan.

Item 16. Form 10-K Summary

None.

SIGNATURES

Pursuant to the requirements of Section

13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the

undersigned, thereunto duly authorized.

Dated: March 31, 2025 Vivani Medical, Inc.

/s/ Adam Mendelsohn

Adam Mendelsohn

Chief Executive Officer

POWER OF ATTORNEY AND SIGNATURES

The undersigned officers and directors

of Vivani Medical, Inc., each hereby severally constitutes and appoints Adam Mendelsohn and Brigid Makes as their true and lawful

attorney-in-fact and agent, with full power of substitution to sign and execute on behalf of the undersigned any and all amendments

to this Annual Report on Form 10-K, and to perform any acts necessary in order to file the same, with all exhibits thereto and

other documents in connection therewith with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent

full power and authority to do and perform each and every act and thing requested and necessary to be done in connection therewith,

as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact

and agent, or their or his or her substitutes, shall do or cause to be done by virtue hereof.

Pursuant to the requirements of

the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and

in the capacities and on the dates indicated.

Name Title Date

/s/ Adam Mendelsohn Chief Executive Officer and Director March 31, 2025

Adam Mendelsohn (Principal Executive Officer)

/s/ Brigid A. Makes Chief Financial Officer March 31, 2025

Brigid A. Makes (Principal Financial and Accounting Officer)

/s/ Gregg Williams Chairman of the Board March 31, 2025

Gregg Williams

/s/ Aaron Mendelsohn Director March 31, 2025

Aaron Mendelsohn

/s/ Dean Baker Director March 31, 2025

Dean Baker

/s/ Alexandra Larson Director March 31, 2025

Alexandra Larson

/s/ Daniel Bradbury Director March 31, 2025

Daniel Bradbury

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Page

Report of Independent Registered Public Accounting Firm (PCAOB ID:207) F-2

Consolidated Balance Sheets as of December 31, 2024 and 2023 F-3

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of

Vivani Medical, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Vivani Medical, Inc. and subsidiaries (the “Company”) as of December 31, 2024 and 2023 and the related consolidated statements of operations, comprehensive loss, stockholders’ equity, and cash flows, for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of their operations and their cash flows for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audit provides a reasonable basis for our opinion.

Critical Audit Matters

Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.

/s/ BPM LLP

We have served as the Company’s auditor since 2014.

Walnut Creek, California

March 30, 2025

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Consolidated Balance Sheets

(In thousands, except per share data)

December 31,

ASSETS

CURRENT ASSETS:

R&D tax credit incentive receivable 253 —

Prepaid expenses and other current assets 1,837 2,408

Operating lease right-of-use assets, net 17,957 19,616

Deposits and other assets 131 52

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES:

Accrued compensation expense 343 396

Lease liability, current portion 1,348 1,383

Commitments and contingencies (Note 13)

STOCKHOLDERS' EQUITY:

Accumulated other comprehensive gain 48 140

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 41,561 $ 45,797

See accompanying notes to consolidated financial statements.

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Consolidated Statements of Operations

(In thousands, except per share data)

Year Ended December 31,

Operating expenses:

Research and development, net of grants $ 15,745 $ 16,968

General and administrative, net of grants 8,932 9,997

Net loss per common share - basic and diluted $ (0.43 ) $ (0.50 )

Weighted average shares outstanding - basic and diluted 54,981 50,853

See accompanying notes to consolidated financial

statements.

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Consolidated Statements of Comprehensive

Loss

(In thousands)

Year Ended December 31,

Other comprehensive income:

Foreign currency translation adjustments (92 ) 105

See accompanying notes to consolidated financial

statements.

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Consolidated Statements of Stockholders’ Equity

(in thousands)

Accumulated

Additional Other Total

Common Stock Paid-in Comprehensive Accumulated Stockholders’

Shares Amount Capital Gain Deficit Equity

Stock-based compensation expense — — 1,864 — — 1,864

Foreign currency translation adjustments — — — 105 — 105

Accumulated

Additional Other Total

Common Stock Paid-in Comprehensive Accumulated Stockholders’

Shares Amount Capital Gain Deficit Equity

Stock-based compensation expense — — 1,610 — — 1,610

Foreign currency translation adjustments — — — (92 ) — (92 )

See accompanying notes to consolidated financial statements.

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Consolidated Statements of Cash Flows

(In thousands)

Year Ended December 31,

CASH FLOWS FROM OPERATING ACTIVIES:

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization of property and equipment 400 357

Equipment write-off and loss on equipment disposal 60 121

Changes in operating assets and liabilities:

R&D tax credit incentive receivable (253 ) —

Prepaid expenses and other assets 491 264

Accrued compensation expenses (53 ) (261 )

Accrued expenses (79 ) (694 )

Net cash used in operating activities (20,786 ) (23,699 )

CASH FLOWS FROM INVESTING ACTIVITIES:

Purchases of property and equipment (556 ) (887 )

Net cash used in investing activities (556 ) (887 )

CASH FLOWS FROM FINANCING ACTIVITIES:

Gross proceeds from insurance premium loan 426 —

Principal payment for insurance premium loan (189 ) —

Proceeds from exercise of common stock options — 133

Net cash provided by financing activities 19,054 133

Effect of exchange rate changes on cash and cash equivalents (14 ) 3

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:

Income taxes paid $ 2 $ 1

NON-CASH INVESTING AND FINANCING ACTIVITIES:

Purchase of property and equipment in accrued expenses $ — $ 132

See accompanying notes to consolidated financial statements.

VIVANI MEDICAL, INC.

AND SUBSIDIARIES

Notes to Consolidated Financial Statements

1. Organization and Business Operations

At Vivani, we are developing a portfolio of miniature, subdermal drug implant candidates 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. In addition, our aim is to minimize fluctuations in patients’ drug levels through the use of our NanoPortal technology, which may improve the tolerability profiles for medicines, including GLP-1 receptor agonists, that produce side effects associated with fluctuating drug levels in the blood.

Vivani announced a change in strategy to discontinue efforts to pursue a

proposed initial public offering and shift focus to file a Form 10 with the SEC

to support the spin-off of Cortigent ;into a fully independent,

publicly traded company. The strategic goal of this transaction is to

create two focused companies dedicated to driving current and future value in

their respective therapeutic areas of expertise.

offering of Cortigent ceased in March 2025 and efforts are now focused on

a potential spinoff with the filing of a Form 10 registration statement. The TFSSA terminated effective December 31, 2024.

In the fourth quarter of 2023, Vivani Medical Australia Pty Ltd., a wholly owned subsidiary in Australia was established to support studies of our product candidates.

On September 26, 2024, the Company reported receiving regulatory approval to initiate its first-in-human clinical trial with a miniature, ultra long-acting GLP-1 (exenatide) implant in obese and overweight individuals in Australia. This clinical trial, known as LIBERATE-1, is part of the NPM-115 program and will investigate the safety, tolerability and full pharmacokinetic profile of an exenatide implant. The trial also represents the first clinical application of the Company’s proprietary NanoPorta drug implant technology. LIBERATE-1 was redesigned to enroll participants who will be 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. Changes in weight will be measured. The trial was initiated at the end of 2024 with data projected to be available in mid-2025.

On March 12, 2025, the Company announced that it intends to spin off Cortigent, Inc., a division that develops brain implant devices to help people recover critical body functions, as an independent publicly-traded company. The strategic goal of this transaction is to create two focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise.

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.

On March 1, 2024, the Company entered into the Securities Purchase Agreement relating to the issuance of 3,947,368 shares of the common stock and warrants to purchase up to an aggregate of 3,947,368 shares of common stock (the “Warrants”), to such investor at a purchase price of $3.80 per share and accompanying warrants in the Offering. The Warrants have an exercise price of $3.80 per share, are exercisable immediately upon issuance and will expire three years following the date of issuance. Simultaneously, the Company also entered into a placement agency agreement with Maxim Group LLC (“Maxim” and such agreement, the “Placement Agency Agreement,” and together with the Securities Purchase Agreement, the “Agreements”), who acted as the sole placement agent for the Offering. The gross proceeds of $15.0 million from the Offering, before paying the placement agent fees and other offering costs, were received on March 5, 2024. In connection with the Securities Purchase Agreement, the Company paid issuance costs of $1.3 million, resulting in net proceeds of $13.7 million. For additional information, refer to Note 7. Equity Securities of the Notes to Condensed Consolidated Financial Statements.

31, 2024, the Company issued 287,970 shares of

common stock for gross proceeds of $504,000 as

part of the Sales Agreement with Jefferies. The Company paid expenses of $344,000, resulting in net proceeds of $160,000.

2. Summary of Significant Accounting Policies

Principles of Consolidation

The accompanying consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“GAAP”) and include the accounts of the Company and its wholly owned subsidiaries. Intercompany balances and transactions have been eliminated in consolidation.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and

liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. We base our estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Management regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates are adjusted accordingly. Significant estimates include those related to assumptions used in accruals for potential liabilities, valuing equity instruments and stock-based compensation, and the realization of deferred tax assets. Actual results could differ materially from those estimates.

Cash, Cash Equivalents and Restricted Cash

We consider all highly liquid investments with a maturity of three months or less at the date of purchase to be cash equivalents. Cash is carried at cost, which approximates fair value, and cash equivalents are carried at fair value. We generally invest funds that are in excess of current needs in high credit quality instruments such as money market funds. As of December 31, 2024 and 2023 restricted cash of $1.3 million and $1.3 million, respectively, relates to a letter of credit as a condition of our facilities lease guarantee requirements and is classified as long-term restricted cash on the consolidated balance sheets.

Property and Equipment

Property and equipment are recorded at historical cost less accumulated depreciation and amortization. When assets are retired or otherwise disposed of, the cost and related accumulated depreciation and amortization are removed from the balance sheets and any resulting gains or losses are reflected in the consolidated statements of operations in the period realized. Maintenance and repairs are charged to operations as incurred.

Depreciation amortization is computed using the straight-line method over the estimated useful lives of the respective assets:

Lab equipment 5 – 7 years

Computer hardware and software 3 – 7 years

Furniture, fixtures and equipment 5 – 10 years

We review our property and equipment for impairment annually or whenever events or changes in circumstances indicate that the carrying value of such assets may not be recoverable.

Depreciation and amortization of property and equipment amounted to $0.4 million and $0.4 million for the years ended December 31, 2024 and 2023, respectively.

Leases

Leases are accounted for under FASB ASC 842, Leases (“ASC 842”). Under ASC 842, the Company determines if an arrangement contains a lease at inception. Right of use assets (“ROU assets”) represent the right to use an underlying asset for the lease term while lease liabilities represent the obligation to make lease payments for the lease term. Leases are then classified as either finance or operating, with classification affecting the pattern of expense recognition in the statements of operations and comprehensive loss. All leases greater than 12 months result in the recognition of a ROU asset and liability at the lease commencement date based on the present value of the lease payments over the lease term. The present value of the lease payments is calculated using the applicable weighted-average discount rate. The weighted-average discount rate is based on the discount rate implicit in the lease, or if the implicit rate is not readily determinable from the lease, the applicable incremental borrowing rate is estimated. The incremental borrowing rate is estimated using the currency denomination of the lease, the contractual lease term and the Company’s applicable borrowing rate. To determine the incremental borrowing rate, reference is made to interest rates that would be available to finance assets similar to the assets under lease in their related geographical location. The Company does not have finance leases.

The Company has elected not to separate non-lease components from lease components and instead to account for each separate lease component and the non-lease components associated with a lease as a single lease component. It also elected to be exempt from balance sheet recognition of all leases with an initial term of 12 months or less.

Certain leases include one or more options to renew with renewal terms that can extend the lease term. The exercise of the lease renewal options is at the Company’s discretion and are included in the determination of the ROU asset and lease liability when the option is reasonably certain of being exercised.

Research and Development

Research and development costs are charged to operations in the period incurred and amounted to $15.7 million and $17.0 million, net of grant revenue, for the years ended December 31, 2024 and 2023, respectively.

Patent Costs

Due to the uncertainty associated with the successful development of one or more commercially viable products based on our research efforts and any related patent applications, all patent costs, including patent-related legal, filing fees and other costs, including internally generated costs, are expensed as incurred. Patent costs were $0.3 million and $0.3 million for the years ended December 31, 2024 and 2023, respectively, and are included in general and administrative expenses in the consolidated statements of operations.

NIH Grant

From time to time, we receive grants that help fund specific development programs. Any amounts received pursuant to grants are offset against the related operating expenses as the costs are incurred.

During the year ended December 31, 2024 grants offset against operating expenses were $0.2 million, of which $0.2 million were offset against research and development expenses. During the year ended December 31, 2023 grants offset against operating expenses were $0.5 million, of which $0.4 million were offset against research and development expenses, and $0.1 million were offset against general and administrative expenses.

Concentration of Credit Risk

Financial instruments that subject us to concentrations of credit risk consist primarily of cash and money market funds. We maintain cash and money market funds with financial institutions that management deems credit worthy, and at times, cash balances may be in excess of FDIC and SIPC insurance limits of $250,000 and $500,000 (including cash of $250,000), respectively.

We also maintain cash at a bank in Switzerland. Accounts at said bank are insured up to an amount specified by the deposit insurance agency of Switzerland.

Foreign Operations

The accompanying consolidated financial statements as of December 31, 2024 and 2023 include assets amounting to approximately $26,000 and $49,000, respectively, relating to our operations in Switzerland. In the fourth quarter of 2023, Vivani Medical

Australia Pty Ltd., a wholly owned subsidiary in Australia was established to

support studies of our product candidates.The accompanying consolidated financial statements as of December 31, 2024 and 2023 include assets amounting to approximately $446,000 and $0, respectively, relating to our operations in Australia. Unanticipated events in foreign countries could disrupt our operations and impair the value of these assets.

Fair Value of Financial Instruments

The authoritative guidance with respect to fair value establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into three levels and requires that assets and liabilities carried at fair value be classified and disclosed in one of three categories, as presented below. Disclosure as to transfers in and out of Levels 1 and 2, and activity in Level 3 fair value measurements, is also required.

Level 1. Observable inputs such as quoted prices in active markets for an identical asset or liability that we have the ability to access as of the measurement date. Financial assets and liabilities utilizing Level 1 inputs include active-exchange traded securities and exchange-based derivatives.

Level 2. Inputs, other than quoted prices included within Level 1, which are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Financial assets and liabilities utilizing Level 2 inputs include fixed income securities, non-exchange-based derivatives, mutual funds, and fair-value hedges.

Level 3. Unobservable inputs in which there is little or no market data for the asset or liability which requires the reporting entity to develop its own assumptions. Financial assets and liabilities utilizing Level 3 inputs include infrequently traded non-exchange-based derivatives and commingled investment funds, and are measured using present value pricing models.

We determine the level in the fair value hierarchy within which each fair value measurement falls in its entirety, based on the lowest level input that is significant to the fair value measurement in its entirety. In determining the appropriate levels, we perform an analysis of the assets and liabilities at each reporting period end.

Cash equivalents, which include certificates of deposit and money market funds, are the only financial instrument measured and recorded at fair value in assets or liabilities on our consolidated balance sheet, and they are valued using Level 1 inputs.

Stock-Based Compensation

Pursuant to FASB ASC 718Share-Based Payment (“ASC 718”), we record stock-based compensation expense for all stock-based awards. Under ASC 718, we estimate the fair value of stock options granted using the option pricing models. The fair value for awards that are expected to vest is then amortized on a straight-line basis over the requisite service period of the award, which is generally the option vesting term. The Company accounts for forfeitures as they occur.

The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option valuation model. The assumptions used in the Black-Scholes valuation model are as follows:

For stock options or restricted stock units (“RSUs”) with market vesting conditions, the awards were valued using the Monte-Carlo Simulation model.

Comprehensive Loss

We comply with provisions of FASB ASC 220, Comprehensive Income, which requires companies to report all changes in equity during a period, except those resulting from investment by owners and distributions to owners, for the period in which they are recognized. Comprehensive income is defined as the change in equity during a period from transactions and other events from non-owner sources.

Comprehensive loss is reported on the face of the financial statements. For the year ended December 31, 2024 and 2023, comprehensive loss is the total of net loss and other comprehensive income which, consists entirely of foreign currency translation adjustments and there were no material reclassifications from other comprehensive loss to net loss during the year ended December 31, 2024 and 2023.

Foreign Currency Translation and Transaction Gains and Losses

The financial statements and transactions of the subsidiary’s operations are reported in the local (functional) currency of Swiss francs (CHF) and of Australian dollars (AUD) and translated into U.S. dollars in accordance with U.S. GAAP. Assets and liabilities of those operations are translated at exchange rates in effect at the balance sheet date. The resulting gains and losses from translating foreign currency financial statements are recorded as other comprehensive income. Revenues and expenses are translated at the average exchange rate for the reporting period. Foreign currency transaction gains (losses) resulting from exchange rate fluctuations on transactions denominated in a currency other than the foreign operations’ functional currencies are included in other expenses in the consolidated statements of operations.

Income Taxes

We account for income taxes under an asset and liability approach for financial

accounting and reporting for income taxes. Accordingly, we recognize deferred

tax assets and liabilities for the expected impact of differences between the

financial statements and the tax basis of assets and liabilities.

We record

a valuation allowance to reduce our deferred tax assets to the amount that is

more likely than not to be realized. In the event we were to determine that we

would be able to realize our deferred tax assets in the future in excess of our

recorded amount, an adjustment to the deferred tax assets would be credited to

operations in the period such determination was made. Likewise, should we

determine that we would not be able to realize all or part of our deferred tax

assets in the future, an adjustment to the deferred tax assets would be charged

to operations in the period such determination was made. We have incurred

losses for tax purposes since inception and have significant tax losses and tax

credit carry-forwards.

Net Loss per Share

Our computation of earnings per share (“EPS”) includes basic and diluted EPS. Basic EPS is measured as the income (loss) available to common shareholders divided by the weighted average number of shares of common stock outstanding for the period. Diluted EPS is similar to basic EPS but presents the dilutive effect on a per share basis of potential common shares (e.g., convertible notes payable, convertible preferred stock, common stock warrants and stock options) as if they had been converted at the beginning of the periods presented, or the issuance date, if later. Potential common shares that have an anti-dilutive effect (i.e., those that increase income per share or decrease loss per share) are excluded from the calculation of diluted EPS.

Net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the respective periods. Basic and diluted loss per common share is the same for all periods presented because all common stock warrants and common stock options outstanding were anti-dilutive.

As of December 31, 2024 and 2023, we excluded the outstanding securities summarized below, which entitle the holders thereof to ultimately acquire shares of common stock, from our calculation of earnings per share, as their effect would have been anti-dilutive (in thousands).

Schedule of net loss per share

December 31,

Shares underlying warrants outstanding 9,340 9,733

Shares underlying stock options outstanding 6,809 6,091

Shares underlying restricted stock units outstanding 695 403

Operating Segments

Operating segments are identified as components of an

enterprise about which separate discrete financial information is available for

evaluation by the chief operating decision-maker in making decisions regarding

resource allocation and assessing performance. Our chief operating

decision-maker, our Chief Executive Officer, reviews financial information

presented for each of our segments. We have two

reporting segments, specifically the Biopharm Division and Neurostimulation

Division. Neither division is revenue producing. The Biopharm Division includes

activities from NPM and Vivani Medical Australia Pty Ltd. The Neurostimulation

Division includes activities from Cortigent and our subsidiary in Switzerland.

During the year ended December 31, 2024, the Biopharm Division and the Neurostimulation Divisionincurred operating expenses of $22.6 million and $2.1 million, respectively. During the year ended December 31, 2024, consolidated net loss for the Biopharm Division was $21.3 million and for the Neurostimulation Division was $2.2 million. As of December 31, 2024, total assets for the Biopharm Division and the Neurostimulation Division were $40.5 million and $1.0 million, respectively. For

further discussion related to segment reporting, please refer to Note 14.

Segment Information.

The Company’s long-term assets are located in the United States.

Recently Adopted Accounting Standards

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2023-07,Improvements to Reportable Segment Disclosures (Topic 280). This ASU updates reportable segment disclosure requirements by requiring disclosures of significant reportable segment expenses that are regularly provided to the Chief Operating Decision Maker (“CODM”) and included within each reported measure of a segment’s profit or loss. This ASU also requires disclosure of the title and position of the individual identified as the CODM and an explanation of how the CODM uses the reported measures of a segment’s profit or loss in assessing segment performance and deciding how to allocate resources. The ASU is effective for the Company for fiscal years beginning on January 1, 2024, and interim periods within fiscal years beginning on January 1, 2025. The Company currently operates two reportable segments and the impact of the adoption of this standard was limited to certain enhanced disclosures in the consolidated financial statements. Segment Information for disclosures related to the adoption of this guidance, please refer to Note. 14 Segment Information.

Recently Issued Accounting Pronouncements Not Yet Adopted as of December 31, 2024

In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures (Topic 740). The ASU requires disaggregated information

about a reporting entity’s effective tax rate reconciliation as well as

additional information on income taxes paid. The ASU is effective on a

prospective basis for annual periods beginning after December 15, 2024. Early

adoption is also permitted for annual financial statements that have not yet

been issued or made available for issuance. This ASU will result in the

required additional disclosures being included in our consolidated financial

statements, once adopted.

November 2024, the FASB issued Accounting Standards Update No. 2024-03 Income

Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures

(Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU

2024-03”), which will improve the disclosures about a public business entity’s expenses and requires

detailed disclosures about specified categories of expenses (including employee

compensation, depreciation, and amortization) included in certain expense

captions such as cost of sales,

selling, general and administrative, and research and development on the face of the income

statement. ASU 2024-03 is effective for the Company or fiscal years beginning

on January 1, 2027, and for interim periods within fiscal years beginning on

January 1, 2028. Early adoption is permitted. The guidance may be applied

either (1) prospectively to financial statements issued for reporting periods

after the effective date of ASU 2024-03 or (2) retrospectively to all prior

periods presented in the financial statements. The Company does not expect the

adoption of this guidance to have a material effect on its consolidated financial

statements and continues to evaluate disclosure presentation alternatives.

3. Fair Value Measurements

Cash equivalents, which include certificates of deposit and money market funds, are the only financial instruments measured and recorded at fair value on our condensed consolidated balance sheet, and are valued using Level 1 inputs. As ofDecember 31, 2024and2023, we did not have any Level 1 and Level 2 financial liabilities or Level 3 financial assets or liabilities measured at fair value on a recurring basis. We did not have any transfers between Level 1 and Level 2 or transfers in or out of Level 3 during the twelve months endedDecember 31, 2024and2023.

The following table presents certificates of deposit and money market

funds at their level within the fair value hierarchy as of December 31, 2024 and 2023 (in thousands).

Total Level 1 Level 2 Level 3

Assets

Cash equivalents

Certificates of deposit $ 9,996 $ 9,996 $ — $ —

Total Level 1 Level 2 Level 3

Assets

Cash equivalents

4. Insurance Premium Financing

In September 2024, we entered into a finance agreement with First Insurance Funding in order to fund a portion of our insurance premiums for our professional liability policies. The amount financed is approximately $426,000 and incurs interest at a rate of 7.2%. The Company is required to make ninemonthly payments of approximately $47,000 through May 2025. The outstanding balance as of December 31, 2024 was approximately $237,000 and is included in accrued expenses in the accompanying condensed consolidated balance sheet.

5. Selected Balance Sheet Detail

Property and equipment, net of accumulated depreciation and

amortization

Property and equipment

consisted of the following as of December 31, 2024 and 2023 (in thousands):

December 31,

Computer software 30 7

Construction in progress — 299

Accumulated depreciation and amortization (2,641 ) (2,442 )

Property and equipment, net $ 1,693 $ 1,729

Contract Liabilities

Contract liabilities amounted to $335,000

and $335,000 as of December 31, 2024 and 2023, respectively, and are included in accrued expenses on the balance sheet.

6. Grants

We received an award for $1.6 million grant (with the intent to fund $6.4 million over five years subject to annual review and approval) from the National Institutes of Health (“NIH”) to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis” that commenced in January 2018. The final year of the grant ended in March 2024, however the NIH issued us a no-cost extension

allowing us to utilize the unfunded amount through March 2025. The NIH grant funds ongoing and planned clinical activities and are being used to conduct and support clinical testing of six subjects implanted with the OrionTM Cortical Visual Prosthesis (“Orion”), submit and obtain Investigational Device Exemption approval from the U.S. Food and Drug Administration (“FDA”). During the year ended December 31, 2024 grants offset against operating expenses were $0.2 million, of which $0.2 million were offset against research and development expenses. During the year ended December 31, 2023 grants offset against operating expenses were $0.5 million, of which $0.4 million were offset against research and development expenses, and $0.1 million were offset against general and administrative expenses. As of December 31, 2024,

we expect $35,000 will be available to offset future operating expenses.

7. Equity Securities

We are authorized to issue 300,000,000 shares of common stock with 59,234,688 issued as of December 31, 2024. In addition, we are authorized to issue 10,000,000 shares of preferred stock with none issued.

Securities Purchase Agreement

On March 1, 2024, the Company entered into the Securities Purchase Agreement relating to the issuance of 3,947,368 shares of the common stock and Warrants to purchase up to an aggregate of 3,947,368 shares of common stock, at a purchase price of $3.80 per share and accompanying warrants in the Offering. The Warrants have an exercise price of $3.80 per share, are exercisable immediately upon issuance and will expire three years following the date of issuance. The Company also entered into a Placement Agency Agreement with Maxim, who acted as the sole placement agent for the Offering. In connection with the Placement Agency Agreement, the Company agreed to pay Maxim an aggregate cash fee of 7.0% of the aggregate proceeds raised from the sale and issuance of the shares of common stock and accompanying warrants. Pursuant to the Placement Agency Agreement, the Company also agreed to reimburse Maxim up to $65,000 for its legal expenses. The gross proceeds of $15.0 million from the Offering, before paying the placement agent fees and other estimated offering costs, were received on March 5, 2024. In connection with the Securities Purchase Agreement, the Company paid issuance costs of $1.3 million, resulting in net proceeds of $13.7 million.

Pursuant to the terms of the Securities Purchase Agreement, until 45 days following the closing of the Offering, the Company agreed not to issue (or enter into any agreement to issue) any shares of common stock or common stock equivalents, subject to certain exceptions. The Company has further agreed not to enter into an agreement involving a variable rate transaction until one year following the closing of the Offering. In addition, the Company’s directors and officers have entered into lock-up agreements with the Company pursuant to which each of them has agreed not to, for a period of 90 days from the closing of the Offering, offer, sell, transfer or otherwise dispose of the Company’s securities, subject to certain exceptions.

Private Sale Transactions

The Sales Agreement

The Company may sell the common stock under the Sales Agreement (A) in privately negotiated transactions; (B) as block transactions; or (C) by any other method permitted by law deemed to be an “at-the-market” offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including sales made directly on the Nasdaq Capital Market or sales made into any other existing trading market for the shares of Common Stock. Jefferies will use commercially reasonable efforts to place the shares of common stock from time to time, based upon the Company's instructions (including any price, time or size limits or other customary parameters or conditions we may impose). The Company will pay Jefferies a commission of up to three percent (3.0%) of the gross sales proceeds of any common stock sold through Jefferies under the Sales Agreement, and also has provided Jefferies with customary indemnification rights. In addition, the Company has agreed to reimburse certain legal expenses and fees incurred by Jefferies in connection with the offering.

The Company is not obligated to make any sales of common stock under the Sales Agreement. The offering of shares of common stock pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all common stock subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with its terms.

During the year ended December 31, 2024, the Company issued 287,970 shares of common stock for gross proceeds of $504,000 as part of the Sales Agreement with Jefferies. The Company paid expenses of $344,000, resulting in net proceeds of $160,000.

8. Warrants

NPM, prior to the Merger with Second Sight, issued common stock and warrants (collectively, the “unit” or “units”) in 2019, 2020 and 2021 for $3.15 per unit. Outstanding warrants to purchase common stock are shown in the table below and generally expire 5 years from the date of issuance at $3.15 per share exercise price, split adjusted, are transferable into one share of common stock and may be exercised on a cashless basis.

In connection with the Securities Purchase Agreement entered on March 1, 2024, relating to the issuance of 3,947,368 shares of the common stock, par value of $0.0001 per share, the Company issued Warrants to purchase 3,947,368 shares of common stock at an exercise price of $3.80 per share. These Warrants are exercisable immediately upon issuance and will expire three years following the date of issuance. The Warrants may be exercised on a cashless basis.

The warrants outstanding as of December 31, 2024 have no intrinsic value.

A summary of warrant activity for the year ended December 31, 2024 and 2023 is presented below (in thousands, except per share and contractual life data).

Weighted Weighted

Average Average

Exercise Remaining

Number of Price Contractual

Shares Per Share Life (in Years)

Issued —

Exercised — $ —

Forfeited or expired (578 ) $ 3.15

Exercised —

9. Employee Benefit Plans

We have a 401(k) Savings Retirement Plan

(the “401(k) Plan”) that covers substantially all full-time employees who meet the 401(k) Plan’s eligibility requirements and

provides for an employee elective contribution. The 401(k) Plan provides for employer matching contributions. Employer contributions are

discretionary and determined annually by the Board of Directors. During the years ended December 31, 2024 and 2023, employer contributions

to the 401(k) Plan totaled $0.2 million and $0.3 million, respectively.

10. Stock-Based Compensation

Equity Incentive Plans

The Vivani Medical, Inc. 2022 Omnibus Incentive Plan (the “2022 Plan”) became effective on August 30, 2022. Under the 2022 Plan, 10,033,333 shares were authorized for issuance at its effective date. The maximum number of shares with respect to which stock awards could be granted is offset and reduced by stock awards previously granted under the Plan. As of December 31, 2024 2,165,958 shares of common stock were available for future issuance under the 2022 Plan pursuant to stock awards that had not previously been granted.

VANI US Equity

VANI · 10-K · period ended 2024-12-31

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Item 7A. Quantitative and Qualitative Disclosures about Market Risk

Item 8. Financial Statements and Supplementary Data

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9A. Controls and Procedures

Item 9B. Other Information

Item 9C. Disclosure regarding foreign jurisdictions that prevent inspections

Item 10. Directors, Executive Officers and Corporate Governance

Item 11. Executive Compensation

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 13. Certain Relationships and Related Transactions, and Director Independence

Item 14. Principal Accounting Fees and Services

Item 15. Exhibits, Financial Statement Schedules

Item 16. Form 10-K Summary

VANI US Equity☆

VANI · 10-K · period ended 2024-12-31

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Item 7A. Quantitative and Qualitative Disclosures about Market Risk

Item 8. Financial Statements and Supplementary Data

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9A. Controls and Procedures

Item 9B. Other Information

Item 9C. Disclosure regarding foreign jurisdictions that prevent inspections

Item 10. Directors, Executive Officers and Corporate Governance

Item 11. Executive Compensation

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 13. Certain Relationships and Related Transactions, and Director Independence

Item 14. Principal Accounting Fees and Services

Item 15. Exhibits, Financial Statement Schedules

Item 16. Form 10-K Summary

VANI US Equity