Vivani Medical, Inc.
For the period ended Dec 31, 2024. Filed Mar 31, 2025.
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FY2024 · Filed Mar 31, 2025
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Notes to Consolidated Financial Statements for the Years Ended December 31, 2024 and 2023
Notes to Consolidated Financial Statements
1. Organization and Business Operations
Vivani Medical, Inc. (“Vivani,” the “Company,” “we,” “us,” “our” or similar terms) is a clinical stage biopharmaceutical company which develops miniaturized, subdermal drug implants utilizing its proprietary NanoPortal™ 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.
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 tosix 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.
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 Pharmaceuticals, Inc. ("Okava").
Vivani resulted from the business combination of Second Sight Medical Products, Inc. (“Second Sight”) and Nano Precision Medical, Inc. (“NPM”). On August 30, 2022, Second Sight and NPM completed their merger pursuant to which NPM became a wholly owned subsidiary of Second Sight and the combined company of NPM and Second Sight was renamed Vivani Medical, Inc. Vivani’s main priority is the further development of its lead program NPM-115, a miniature,6-month, GLP-1 implant candidate for chronic weight management in obese or overweight patients withone 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.
On July 6, 2023, Vivani changed 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’s stockholders 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 exenatide implant in patients with type 2 diabetes. On August 18, 2023, FDA provided written notification that the study was on full clinical hold, primarily due to insufficient Chemistry, Manufacturing, and Controls (“CMC”) information to assess the risk to human subjects. After providing additional information to sufficiently address the FDA's requests, 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 incorporated Bydureon BCise® (exenatide injection) 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 afive-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 Agreement SM (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 deliversix 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-1™, 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 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 November 8, 2024, the Company entered into a private sale transaction withone 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 attwo study centers in Australia. The primary objective of the study is to investigate the safety, tolerability and full pharmacokinetic profile of anexenatide implant in obese or overweight individuals. Consistent with previous guidance, study results are anticipated to be reported 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.
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 ofhealthcare’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.
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 withno 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.
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. 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.
On November 8, 2024, the Company entered into a private sale transaction withone 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.
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.
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 includethe 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 liabilitiesand 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 ofthree 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 |
Wereview 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 includeone 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 ofone 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 inone ofthree 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 718 Share-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:
| ● | The grant price of the issuances is determined based on the fair value of the shares at the date of grant. |
| ● | The risk-free interest rate for periods within the contractual life of the option is based on the U.S. treasury yield in effect at the time of grant. |
| ● | We calculate the expected term of options using a weighted average of option vesting periods and an estimate of one-half of the period between vesting and expiration of the option. |
| ● | Volatility is determined based on our average historical volatilities since our trading history, supplemented with average historical volatilities of comparable companies in our similar industry. |
| ● | Expected dividend yield is based on current yield at the grant date or the average dividend yield over the historical period. We have never declared or paid dividends and have no plans to do so in the foreseeable future. |
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
Weaccount 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.
Werecord 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).
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| 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 |
| Total | 16,844 | 16,227 |
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 havetwo 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 andthe Neurostimulation Division incurred 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.
In November 2024, the FASB issued Accounting Standards Update No. 2024-03Income 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 andrequires 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.
- 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 of December 31, 2024 and 2023, 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 ended December 31, 2024 and 2023.
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 | $— | $— |
| Money market funds | 7,441 | 7,441 | — | — |
| Total | $17,437 | $17,437 | $— | $— |
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| Assets | ||||
| Cash equivalents | ||||
| Money market funds | $18,629 | $18,629 | $— | $— |
| Total | $18,629 | $18,629 | $— | $— |
- 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 nine monthly 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, | ||
|---|---|---|
| 2024 | 2023 | |
| Equipment | $3,937 | $3,511 |
| Furniture and fixtures | 367 | 354 |
| Computer software | 30 | 7 |
| Construction in progress | — | 299 |
| Total property and equipment | 4,334 | 4,171 |
| 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 ofsix subjects implanted with the Orion™ 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
On November 8, 2024, the Company entered into a private sale transaction withone 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.
The Sales Agreement
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.
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 tothree 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 intoone 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 haveno 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) | |
| Warrants outstanding as of December 31, 2022 | 10,311 | $11.13 | |
| Issued | — | ||
| Exercised | — | $— | |
| Forfeited or expired | (578) | $3.15 | |
| Warrants outstanding as of December 31, 2023 | 9,733 | $11.60 | 1.4 |
| Issued | 3,947 | $3.80 | |
| Exercised | — | ||
| Forfeited or expired | (4,340) | $22.10 | |
| Warrants outstanding as of December 31, 2024 | 9,340 | $3.42 | 1.6 |
| Warrants exercisable as of December 31, 2024 | 9,340 | $3.42 | 1.6 |
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, 20242,165,958 shares of common stock were available for future issuance under the 2022 Plan pursuant to stock awards that had not previously been granted.
For stock option grants, the option price is determined by the Board of Directors but cannot be less than the fair value of the shares at the grant date. Generally, theoptions vest ratably over four years and expireten years from the grant date. The 2022 plan provides for accelerated vesting if there is a change of control, as defined in the 2022 Plan.
Stock Options
A summary of stock option activity is presented below (in thousands, except per share and contractual life data).
| Weighted | |||
|---|---|---|---|
| Weighted · Average | |||
| Average · Remaining | |||
| Exercise · Contractual | |||
| Number of | Price | Life | |
| Shares | Per Share | (in Years) | |
| Options outstanding at December 31, 2022 | 5,272 | $3.07 | |
| Granted | 1,384 | $1.22 | |
| Exercised | (333) | $0.52 | |
| Forfeited or expired | (232) | $8.12 | |
| Other adjustment | — | $— | |
| Options outstanding at December 31, 2023 | 6,091 | $2.60 | |
| Granted | 1,093 | $1.57 | |
| Exercised | — | $— | |
| Forfeited or expired | (375) | $1.19 | |
| Options outstanding, vested and expected to vest as of December 31, 2024 | 6,809 | $2.52 | 6.55 |
| Options exercisable as of December 31, 2024 | 4,813 | $2.91 | 5.69 |
The estimated aggregate intrinsic value of stock options exercisable as of December 31, 2024 was $0.1 million.
Restricted Stock Units (RSUs)
A summary of restricted stock activity and related information (in thousands, except per share data):
| Number of Shares | Weighted Average Grant Date Fair Value Per Share | |
|---|---|---|
| Outstanding as of December 31, 2023 | 403 | $0.93 |
| Granted | 292 | $1.69 |
| Vested and released | — | $— |
| Forfeited and canceled | — | $— |
| Outstanding as of December 31, 2024 | 695 | $1.25 |
During the years ended December 31, 2024 and 2023, the Company granted 292,500 and 402,500 RSUs, respectively, subject to market conditions which required our stock price to exceed $3.15 per share forthree consecutive days in thefour years from grant date for the RSUs to vest. Upon achievement of the market condition, one-third of the award will vest, and thereafter, one-third of the award will vest on the first and second anniversary of the achievement date, subject to the recipient’s continued service through each applicable vesting date.
Stock-Based Compensation Expense
The following table summarizes total stock-based compensation expense for stock options and RSUs, which is included in the statements of operations (in thousands).
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development | $1,001 | $1,219 |
| General and administrative | 609 | 645 |
| Total stock-based compensation expense | $1,610 | $1,864 |
As of December 31, 2024, there was $1.9 million of total unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over a weighted average period of 1.3 years. As of December 31, 2024, there was $0.2 million of total unrecognized compensation expense related to outstanding RSUs that will be recognized over a weighted average period of 0.8 years.
Stock Options
During the year ended December 31, 2024 and 2023, we granted stock options to purchase shares of common stock to certain employees and board members at a weighted average price of $1.26 and $0.93 per share, respectively, which was calculated at the fair value of our common stock on the respective grant date. The options generally vest over a period offour years.
Stock Options (Service Vesting)
During the year ended December 31, 2024,1,092,836 stock options subject to service vesting, were issued and valued at $1.4 million using the Black-Scholes option-pricing model. During the year ended December 31, 2023,1,183,817 stock options subject to service vesting, were issued and valued at $1.2 million using the Black-Scholes option-pricing model. The calculated value of each option grant was estimated on the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions.
| 2024 | 2023 | |
|---|---|---|
| Risk-free interest rate | 3.79% to 5.53% | 3.99% – 4.79% |
| Expected dividend yield | —% | —% |
| Expected volatility | 100% | 100% |
| Expected term | 5.04-6.08 years | 4.00-6.20 years |
Stock Options (Market Conditions Vesting)
During the year ended December 31, 2023,200,000 stock options were granted and subject to market conditions which required our stock price to exceed $6.30 per share forthree consecutive days in thefour years from grant date for the stock option to vest. These stock options with market conditions vesting were valued at $0.1 million. The fair value of these options subject to market conditions were valued using the Monte-Carlo Simulation model with the following assumptions:
| ● | Beginning Stock Price. We utilized the Company’s publicly traded share price as of the Valuation Date as the beginning stock value. At the Valuation Date, the publicly traded common share price was $1.09 per share. |
| ● | Drift Rate. In determining the value of the instrument in the risk-neutral framework, risk-free rates were estimated based on the applicable treasury rate for the projection period. For each simulation, the term of the risk-free rate was based on the term from the Valuation Date through the latest date on which the award could vest (i.e., two years following the Performance Period End Date). Please note that, for the purposes of calculating the service period associated with the Subject Interest, the Company’s cost of equity was utilized as the drift rate. |
| ● | Volatility. The total equity volatility (standard deviation) was based on a total equity volatility analysis. |
| ● | Period. The period was measured as the number of years from the Valuation Date through the PSO expiration date (10 years following the date of grant). |
| ● | Dividends. The Company has not historically paid dividends. In addition, the Company does not expect to pay dividends going forward. As such, no dividends were considered in our analysis. |
Restricted Stock Units (RSUs)
During the year ended December 31, 2024, the Company granted 292,500 RSUs. These RSUs are subject to market conditions which required our stock price to exceed $3.15 per share forthree consecutive days in thefour years from grant date for the RSUs to vest.
The assumptions used to estimate the fair value of the performance-based restricted stock units granted during the years ended December 31, 2024 and 2023 and valued using a Monte Carlo simulation were as follows:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| RSUs Granted | 292,500 | 402,500 |
| Valuation date stock price | $1.81 | $0.93 |
| Risk-free interest rate | 4.53% | 4.13% |
| Expected divided yield | 0% | 0% |
| Expected volatility | 100% | 100% |
| Simulation term | 4 years | 1.1 years |
The steps involved in utilizing the Monte Carlo simulation in order to value the performance-based RSUs included the following:
**1. Projection of the Company’s Common Stock Value.**The performance-based RSUs were measured based on the Company’s underlying common stock value over the performance period (four years following the Valuation Date).
Additionally, we considered thetwo-year vesting period following achievement of the performance condition. Accordingly, our common stock value was simulated over asix-year period to capture iterations through which the performance condition was satisfied on the Performance Period End Date. The analysis involved projecting our common stock value starting with our current common stock value. The forecasted stock price was based on the Geometric Brownian motion (“GBM”), and the Monte Carlo simulation generated random variables using the GBM to forecast our stock price on a daily basis over the specified period assuming 252 trading days per year. The Monte Carlo simulation for the PSO utilized the following assumptions:
| ● | Beginning Stock Price. As of the Valuation Date, we were a publicly traded company with an observable share price. Therefore, we utilized our publicly traded share price as of the Valuation Date as the beginning stock value. |
| ● | Drift Rate. In determining the value of the instrument in the risk-neutral framework, risk free rates were estimated based on the applicable treasury rate for the projection period. For each simulation, the term of the risk-free rate was based on the term from the Valuation Date through the latest date on which the award could vest (i.e., two years following the Performance Period End Date). Please note that, for the purposes of calculating the service period associated with the Subject Interest, our cost of equity was utilized as the drift rate. |
| ● | Volatility. The total equity volatility (standard deviation) was based on a total equity volatility analysis. |
| ● | Period. The period was measured as the number of years from the Valuation Date through the latest date on which the award could vest. |
| ● | Dividends. We have not historically paid dividends nor do we expect to pay dividends going forward. As such, no dividends were considered in our analysis. |
**2. Consideration of the Performance-Vesting Schedule.**As previously discussed, our publicly traded common share price must equal or exceed the Stock Price Hurdle amount of $3.15 over athree-consecutive-trading-day rolling period on or before the Performance Period End Date. If such performance condition is achieved, one-third of the award shall vest on the Hurdle Achievement Date, one-third of the award shall vestone year following the Hurdle Achievement Date, andone-third of the award shall vesttwo years following the Hurdle Achievement Date.
3. Performance-Based RSU Value Conclusion. The proceeds from the vesting of common shares were then discounted to the Valuation Date using the applicable risk-free rate, which is consistent with the assumption utilized to project stock prices in our Monte Carlo simulation. For the purposes of calculating the weighted service period associated with the Subject Interest, a separate simulation was performed using our cost of equity as the drift rate. The service period was then determined based on the median Hurdle Achievement Date.
11. Income Taxes
As discussed inNote 1, Organization and Business Operations, Nano Precision Medical, Inc. and Second Sight Medical Products, Inc. merged on August 30, 2022. The transaction was accounted for as a reverse merger business combination under GAAP. Accordingly, the consolidated income tax provision includes NPM for all periods presented, and the legacy Second Sight business of Vivani since the date of the merger.
Due to the net losses in 2024 and 2023, the provision for income taxes consists only of minimum California franchise taxes presented in general and administrative expenses.
The components of deferred income assets and liabilities as of December 31, 2024 and 2023 are as follows (in thousands):
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Deferred Tax: | ||
| Accruals and reserves | $523 | $1,101 |
| Capitalized R&E §174 | 6,722 | 5,120 |
| Lease ROU | 379 | 302 |
| Stock compensation | 1,992 | 1,541 |
| Net operating loss | 52,588 | 48,170 |
| R&D credit | 9,459 | 6,770 |
| Gross deferred tax assets | 71,663 | 63,004 |
| Investment in subsidiary | (1,924) | (1,924) |
| Accumulated depreciation and amortization | (158) | (200) |
| Gross deferred tax liabilities | (2,082) | (2,124) |
| Valuation Allowance | (69,581) | (60,880) |
| Total Deferred Tax Assets, Net | $— | $— |
| Change in Valuation Allowance for the Year Ended | $8,702 | $6,046 |
The reconciliation of income tax computed at the expected U.S. federal statutory tax rate of 21% to income tax expense (benefit) and the corresponding rate from operations consist of the following (in thousands) for the year ended December 31, 2024 and 2023:
| For the Year Ended December 31, | ||||
|---|---|---|---|---|
| 2024 · 2023 | ||||
| Pre-tax loss | $(23,487) | $(25,652) | ||
| Federal tax (benefit) at statutory rate | $(4,932) | 21.0% | $(5,387) | 21.0% |
| State tax (benefit), net of federal tax benefit | (1,568) | 7.0% | (1,791) | 7.0% |
| R&D tax credit from current year | (2,591) | 11.0% | (1,050) | 4.1% |
| Impact on effective rate of loss eliminated in consolidation | — | —% | — | —% |
| Other | 392 | (1.7)% | 2,184 | -8.5% |
| Change in valuation allowance | 8,702 | (37.1)% | 6,046 | -23.6% |
| Total provision for income taxes | $3 | 0.0% | 2 | 0.0% |
Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to utilize the existing deferred tax assets. Based on this evaluation, as of December 31, 2024 and 2023, a full valuation allowance has been recorded because deferred tax assets have been assessed to be less than “more likely than not” to be realized.
As of December 31, 2024, we had federal and apportioned state net operating loss (“NOL”) and federal and state R&D credit carry-forwards available to offset future taxable income and income taxes as follows (in thousands):
| Pre TCJA (Tax Cuts and Jobs Acts of 2017) period federal NOL carry-forward, begin expiring 2030 | $47,353 |
|---|---|
| Post TCJA period federal NOL carry-forward, with no carry-forward limitation | 151,315 |
| Total federal NOL carry-forward | $198,668 |
| State NOL carry-forward, begin expiring 2030 | $143,717 |
| Federal R&D tax credit carry-forward, begin expiring in 2036 | $4,907 |
| State R&D carry-forward, no expiration date | $8,755 |
| Total R&E related deferred income tax assets (net of applicable amortization) | $6,722 |
| Reserve for uncertain income tax positions | Nil |
As of December 31, 2024, the Company has Federal and California research and development credit carryforwards of $4.9 million and $8.7 million, respectively. The Federal research and development credit carryforwards will expire beginning in 2036 if not utilized. The California research and development credits have no expiration date.
Under recently enacted U.S. tax legislation, although the treatment of tax losses generated in taxable years ending before December 31, 2017, has generally not changed, tax losses generated in taxable years beginning after December 31, 2017, may only be utilized to offset 80% of taxable income annually. This change may require NPM and Legacy SSMP to pay federal income taxes in future years despite generating a loss for federal income tax purposes in prior years.
To the extent that each of the tax filers continue to generate taxable losses, unused losses will carry-forward to offset future taxable income, if any, until these unused losses expire. However, the tax filers may be unable to use these losses to offset taxable income before our unused losses expire at various dates that range from 2030 through 2037 for federal net operating losses generated before 2018. Federal net operating losses generated for year 2018 and forward do not expire. State net operating losses expire from 2030 through 2042. Under Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in its equity ownership over athree-year period, the corporation’s ability to use its pre-change net operating loss, or NOL, carry-forwards to offset its post-change taxable income may be limited. Limitations may also apply to the utilization of other pre-change tax attributes as a result of an ownership change.
Second Sight Medical Products, Inc. experienced an “ownership change” within the meaning of Section 382(g) of the Code during the third quarter of 2022 as a result of the merger. The ownership change will subject its net operating loss carry-forwards to an annual limitation, which will significantly restrict its ability to use them to offset taxable income in periods following the ownership change. In general, the annual use limitation equals the aggregate value of stock at the time of the ownership change multiplied by a tax-exempt interest rate specified by the Internal Revenue Service. We have not yet fully analyzed the available information to determine the amount of the annual limitation.
The Company has the following activity relating to unrecognized tax benefits (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Balance at beginning of year | $1,692 | $— |
| Increases based on tax positions related to the current year | 648 | 262 |
| Increases based on tax positions related to prior years | 24 | 1,430 |
| Reductions based on tax positions related to prior years | — | — |
| Balance at end of year | $2,364 | $1,692 |
As of December 31, 2024, the Company had $2.4 million of unrecognized tax benefits which are comprised of federal of $1.0 million and California of $1.4 million. The Company’s unrecognized gross tax benefits would not reduce its annual effective tax rate if recognized because the Company has recorded a full valuation allowance on deferred tax assets. The Company does not foresee any material changes to its gross unrecognized tax benefit within the next 12 months. The Company recognizes interest and/or penalties related to income tax matters in income tax expense. The Company did not recognize any accrued interest and penalties related to gross unrecognized tax benefits related to the year ended December 31, 2024 and 2023. All years are open for examination by federal and state authorities. The Company currently has no federal or state tax examinations in progress.
Beginning January 1, 2022, we are required to capitalize certain research and development expenditures in accordance with section 174 of the Internal Revenue Code, as amended by the Tax Cuts and Jobs Act of 2017, instead of previously being allowed to expense. Amortization of such capitalized expenditures are allowed over a 5-year period if incurred in the U.S. or a 15-year period if incurred outside the United States.
We file income tax returns in the U.S. federal jurisdiction and various states and are subject to income tax examinations by federal tax authorities for tax years ended 2017 and later and by state authorities for tax years ended 2016 and later. We currently are not under examination by any tax authority. Our policy is to record interest and penalties on uncertain tax positions as income tax expense. As of December 31, 2024 and 2023, we haveno accrued interest or penalties related to uncertain tax positions. Second Sight Switzerland, our foreign subsidiary, has not had any taxable income in the prior and current years.
12. Right-of-use Assets and Operating Lease Liabilities
We lease certain office, laboratory, research and development space for our use. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Operating lease cost for the operating lease is recognized on a straight-line basis over the lease term and is included in operating expenses on the consolidated statements of operations and comprehensive loss. Our lease agreements do not contain any material residual value guarantees or restrictive covenants. As most of our leases do not provide an implicit rate, we used our estimated incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments.
On November 21, 2022, Vivani entered into a triple net lease agreement for a single building with 43,645 square feet of space in Alameda, California. The stated term of the lease commenced on June 1, 2023 and terminates on September 30, 2033, ten years and 4 months. The lease term is based on the non-cancellable period in the lease agreement. There are two options to extend the lease, each for a term of five years; however, the extension options were not included in the measurement of the ROU asset and lease liability since it is not reasonably certain that the Company will exercise such extension options. Payments increase annually from $2,676,311 to $3,596,784, or 124 monthly payments less the first four which are abated, totaling approximately $31.0 million. Vivani will be responsible for insurance, property taxes and common area maintenance charges. Vivani deposited $1.3 million to guarantee a letter of credit to secure the lease and this amount is included in long-term assets on the balance sheet as of December 31, 2024. The lease in Emeryville, California expired on September 30, 2023.
On February 1, 2023, we entered into a lease agreement, effective March 1, 2023, to sublease office space to replace Cortigent’s existing headquarters. Our rental payments amount to $22,158 per month plus operating expenses, to lease 14,823 square feet of office space at 27200 Tourney Road, Valencia, California 91355. The sublease has a term of two years and two months. The sublease expires on April 30, 2025. We also entered into a leasefor storage space on January 25, 2023, in the same building at a cost of $6,775 per month for a term of two years and one month. The lease expires on March 31, 2025. We are not renewing the current office lease. However we are entering into another lease in the same building for a smaller space at a cost of $1,700 per month forsix months. We are renewing the lease of the storage unit. These new and renewal leases will be short-term leases with immaterial monthly costs.
On July 3, 2024, we entered into a short-term sublease agreement for access to manufacturing facility with an extension option that is not expected to be exercised. The sublease expires on June 30, 2025.
The following table summarizes supplemental balance sheet information related to the Company’s operating leases (in thousands):
| December 31, | |||
|---|---|---|---|
| Balance Sheet Classification | 2024 | 2023 | |
| Assets | |||
| Non-current assets | Right-of-use assets | $17,957 | $19,616 |
| Liabilities | |||
| Current | Current operating lease liabilities | $1,348 | $1,383 |
| Long-term | Long-term operating lease liabilities | $17,965 | $19,313 |
Operating lease cost was $3.3 million and $2.8 million during 2024 and 2023, respectively. Variable lease cost, comprising primarily of common area maintenance charges and taxes, for the operating lease was $0.4 million and $1.1 million during 2024 and 2023, respectively. Short-term sublease costs were $200,000 during 2024.
The following table summarizes a maturity analysis of our lease liabilities showing the aggregate lease payments as of December 31, 2024 (in thousands except weighted average data):
| Year Ending December 31, | |
|---|---|
| 2025 | $2,914 |
| 2026 | 2,889 |
| 2027 | 2,976 |
| 2028 | 3,065 |
| 2029 | 3,156 |
| Thereafter | 12,704 |
| Total lease payments | 27,704 |
| Less imputed interest | (8,391) |
| Total lease liabilities | $19,313 |
| Weighted average remaining lease term | 8.70 years |
Other information related to leases are as follows (in thousands):
| Year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Cash paid for operating lease liabilities | $3,070 | $1,932 |
| Weighted average discount rate | 8.40% | 8.41% |
13. Commitments and Contingencies
Indemnification Agreements
We maintain indemnification agreements with our directors and officers that may require us to indemnify them against liabilities that arise by reason of their status or service as directors or officers, except as prohibited by applicable law.
Clinical Trial Agreements
Based upon FDA approval of Argus II, which was obtained in February 2013, we were required to collect follow-up data from subjects enrolled in our pre-approval trial for a period of up toten years post-implant, which was extended through the year 2019. This requirement to collect follow-up data was halted in 2020 with FDA approval. In addition, we conducted three post-market studies to comply with U.S. FDA, French, and European post-market surveillance regulations and requirements and are conducting an early feasibility clinical study of Orion. We have contracted with various universities, hospitals, and medical practices to provide these services. Payments are based on procedures performed for each subject and are charged to clinical and regulatory expense as incurred. Total amounts expensed for the year ended December 31, 2024 and 2023 were $17,000 and $0.1 million, respectively.
Litigation, Claims and Assessments
Three oppositions filed by Pixium Vision are pending in the European Patent Office, each challenging the validity of a European patent owned by Cortigent. The outcomes of the challenges are not certain, however, if successful, they may affect our ability to block competitors from utilizing Cortigent’s neurostimulation patented technology. We believe a successful challenge will not have a material effect on our ability to manufacture and sell our products, or otherwise have a material effect on Cortigent’s operations.
As described in the Company’s 10-K for the year ended December 31, 2020, the Company had entered into a Memorandum of Understanding (“MOU”) for a proposed business combination with Pixium Vision SA (“Pixium”). In response to a press release by Pixium dated March 24, 2021, and subsequent communications between us and Pixium, our Board of Directors determined that the business combination with Pixium was not in the best interest of our shareholders. On April 1, 2021, we gave notice to Pixium that we were terminating the MOU between the parties and seeking an amicable resolution of termination amounts that may be due, however no assurance can be given that an amicable resolution will be reached. We accrued $1,000,000 of liquidated damages as contemplated by the MOU in accounts payable as of March 31, 2021 and remitted that amount to Pixium in April 2021. Pixium indicated that it considered this termination wrongful, rejected the Company’s offers, but retained the $1,000,000 payment. On May 19, 2021, Pixium filed suit in the Paris Commercial Court, and currently claim damages of approximately € 5.1 million or about $5.6 million. We believe we have fulfilled our obligations to Pixium with the liquidated damages payment of $1,000,000. On December 8, 2022, the Company received notice that the Paris Commercial Court has rendered its judgement, including finding that the Company’s termination of the MOU was not valid. In the judgment, the Company was ordered to pay to Pixium the amount of €2,500,000 minus a €947,780 credit for the $1,000,000 already paid for, a net amount payable of approximately €1,552,220. On May 24, 2023, the Company filed an appeal against the judgment from the Paris Commercial Court except in so far as such prior judgment dismissed (i) Pixium’s claim for the Company to pay it a sum of €480,693 relating to the alleged time spent by its teams, (ii) Pixium’s application to order the Company to pay it a sum of €1,500,000 in respect to alleged loss of opportunity and (iii) deducted the sum of $1,000,000 that we already paid Pixium and which Pixium retained. Thereafter Pixium filed its brief with Paris Court of Appeal and filed a cross-appeal on January 18, 2024. Meanwhile,the Company received notice that the Paris Commercial Court had opened safeguard proceedings against Pixium by judgment dated October 9, 2023, then in its judgment dated November 13, 2023, converted safeguard proceedings into receivership, and in its judgment dated January 31, 2024, converted Pixium’s receivership proceedings to liquidation proceedings, the transfer plan being rejected. As a result, Pixium’s liquidator intervened on behalf of Pixium in the pending proceedings before the Paris Court of Appeal and filed its brief on March 21, 2024. The Company filed its brief in reply with the Paris Court of Appeal on April 17, 2024. Proceedings before the Paris Court of Appeal are pending. In parallel, since the Company has failed to enforce the judgment, Pixium has requested the pre-trial judge to strike out the Company's appeal for failure to enforce the judgment.The hearing took place on June 4, 2024, and on October 23, 2024, the pre-trial judge issued his order, striking out Vivani's appeal for failure to enforce the decision. Within two years,Vivani will have to request that the case be reinstated on the court's docket, providing evidence that the judgment has been fully enforced or, at the very least, that an agreement has been reached. Failing this, the appeal proceedings will lapse.
The Company recorded a charge of $1,675,000 for the year ended December 31, 2022 related to this matter but plans to continue its appeal against the preliminary judgment.
We are party to litigation arising in the ordinary course of business. It is our opinion that the outcome of such matters will not have a material effect on our results of operations, however, the results of litigation and claims are inherently unpredictable. Regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.
14. Segment Information
Operating segments are defined as components of an enterprise for which separate financial information is available for evaluation by the chief operating decision maker (“CODM”) in deciding how to allocate resources and assess performance. The Company hastwo operating and reporting segments, the Biopharm Division and the Neurostimulation Division. The Company’s CODM is its Chief Executive Officer who reviews the Company between Biopharm and Cortigent. Our primary focus is the Biopharm Division. We are trying to spin off Cortigent. The measure of segment loss is reported on the Consolidated Statements of Operations and Comprehensive Loss as net loss. The measure of segment assets is reported on the Consolidated Balance Sheets as total assets.
The Company has not generated any product revenue to date. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it is a clinical stage biopharmaceutical company.
The following table provides information related to our operating segments based upon the Company's net loss for thetwo years ended December 31, 2024 and 2023 (in thousands):
| Year Ended December 31, | ||||||
|---|---|---|---|---|---|---|
| 2024 · 2023 | ||||||
| Biopharm · Neurostimulation · Biopharm · Neurostimulation | ||||||
| Division | Division | Total | Division | Division | Total | |
| Operating expenses: | ||||||
| Personnel and related expenses | $10,053 | $1,752 | $11,805 | $9,722 | $3,300 | $13,022 |
| Office space rental related expenses | 3,999 | — | 3,999 | 3,990 | — | 3,990 |
| Development expenses | 2,765 | 294 | 3,059 | 2,577 | 1,934 | 4,511 |
| Professional services and insurance | 4,600 | — | 4,600 | 4,146 | — | 4,146 |
| Depreciation and amortization | 378 | 30 | 408 | 307 | 44 | 351 |
| Other general and administrative expenses | 806 | — | 806 | 945 | — | 945 |
| Other (income) expense, net | (1,347) | 156 | (1,191) | (1,426) | 113 | (1,313) |
| Segment net loss | $21,254 | $2,232 | $23,486 | $20,261 | $5,391 | $25,652 |
15. Subsequent Event
The Company evaluated subsequent events for recognition and disclosure through the date the financial statements were issued or filed. Nothing has occurred outside normal operations that required recognition or disclosure in these financial statements except as follows:
Private Sale Transaction
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.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.