Envoy Medical, Inc.
For the period ended Mar 31, 2025. Filed May 1, 2025.
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Mar 31, 2025 · Filed May 1, 2025
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Notes to Unaudited Condensed Consolidated Financial Statements
1. Nature of the Business and Basis of Presentation
Envoy Medical, Inc. (“Envoy Medical” or the “Company”) is a hearing health company focused on providing innovative medical technologies across the hearing loss spectrum. Envoy Medical’s technologies are designed to shift the paradigm within the hearing industry and bring both providers and patients the hearing devices they desire. The Company’s first commercial product, the Esteem® Fully Implanted Active Middle Ear Implant (“Esteem FI-AMEI”), is a fully implanted active middle ear hearing device. The Esteem FI-AMEI was approved for sale in 2010 by the United States Food and Drug Administration (“FDA”).
Envoy Medical believes the fully implanted Acclaim® Cochlear Implant (“Acclaim CI”) is a first-of-its-kind cochlear implant. Envoy Medical’s fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI will only be indicated for adults who have been deemed adequate candidates by a qualified physician. The Acclaim CI received the Breakthrough Device Designation from the FDA in 2019.
On September 29, 2023 (the “Closing Date”), a merger transaction between Envoy Medical Corporation, Anzu Special Acquisition Corp I (“Anzu”) and Envoy Merger Sub, Inc., a directly, wholly owned subsidiary of Anzu (“Merger Sub”) was completed (hereinafter, the “Merger” or “Business Combination”) pursuant to the business combination agreement, dated as of April 17, 2023 (as amended, the “Business Combination Agreement”). In connection with the closing of the Merger (the “Closing”), Merger Sub merged with Envoy Medical Corporation, with Envoy Medical Corporation surviving the merger as a wholly owned subsidiary of Anzu. In connection with the Closing, Anzu changed its name to Envoy Medical, Inc. The Company’s Class A common stock, par value $0.0001 per share (“Common Stock”), and the Company’s public warrants commenced trading on the Nasdaq Stock Market LLC (“Nasdaq”) on October 2, 2023 under the symbols “COCH” and “COCHW,” respectively.
On April 17, 2023, prior to entering into the Business Combination Agreement, Anzu and Envoy Medical Corporation entered into an agreement (as amended to date, the “Forward Purchase Agreement”) with Meteora Special Opportunity Fund I, LP (“MSOF”), Meteora Capital Partners, LP (“MCP”), Meteora Select Trading Opportunities Master, LP (“MSTO”) and Meteora Strategic Capital, LLC (“MSC” and, collectively with MSOF, MCP and MSTO, the “Sellers” or “Meteora parties”) for an over-the-counter equity prepaid forward transaction.
Pursuant to the terms of the Forward Purchase Agreement, on the Closing Date, the Sellers purchased 425,606 shares of the Company’s Common Stock (the “Recycled Shares”) directly from the redeeming stockholders of Anzu. Also, effective upon the Closing Date, the Company paid to the Sellers a prepayment amount of $4.5 million required under the Forward Purchase Agreement directly from the trust account and transferred to the Sellers 8,512 shares of the Company’s Common Stock (the “Share Consideration”). During the year ended December 31, 2024, the Sellers sold the full amount of the Recycled Shares and, pursuant to the Forward Purchase Agreement, the Company received $4.00 per share sold, or $1.7 million.
In addition, pursuant to the subscription agreement dated April 17, 2023 (as amended to date, the “Subscription Agreement”), by and between Anzu and Anzu SPAC GP I LLC (the “Sponsor”), the Company issued, and certain affiliates of the Sponsor purchased, concurrently with the Closing, an aggregate of 1,000,000 shares of the Company’s Series A preferred stock, par value $0.0001 per share (“Series A Preferred Stock”) in a private placement (the “PIPE Transaction”) at a price of $10.00 per share for an aggregate purchase price of $10.0 million.
The condensed consolidated financial statements include the accounts of Envoy Medical and its wholly-owned subsidiaries Envoy Medical Corporation and Envoy Medical GmbH (Ansbach) (GmbH), which operates a sales office in Germany. All intercompany accounts and transactions have been eliminated in consolidation.
Unaudited financial information
The Company’s unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Pursuant to these rules and regulations, they do not include all information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, the unaudited condensed consolidated financial statements reflect all adjustments, consisting of a normal recurring nature, considered necessary for a fair statement of the Company’s financial condition and results of operations. Operating results for the periods presented are not necessarily indicative of the results that might be expected for the full year. As such, the information included in this report should be read in conjunction with the Company’s audited financial statements as of and for the year ended December 31, 2024, which are included in the Company’s Form 10-K, dated and filed with the SEC on March 31, 2025, which is accessible on the SEC’s website at www.sec.gov. The condensed consolidated balance sheet as of December 31, 2024 has been derived from the audited consolidated financial statements of the Company, but does not include all the disclosures required by U.S. GAAP.
During the three months ended March 31, 2025, there were no changes to the Company’s significant accounting policies as described in the Company’s audited consolidated financial statements as of and for the year ended December 31, 2024.
2. Summary of Significant Accounting Policies
Going Concern
Since inception, the Company has incurred cumulative losses from operations and has an accumulated deficit of $291.0 million at March 31, 2025. From February 2024 to March 2025, the Company received advances of $25.0 million from term loans provided by a related party (see Note 8). In February 2024, the Company received net proceeds of $1.7 million from the sale of 425,606 shares of Common Stock held by the Meteora parties (see Note 1). On various dates in 2024, the Company received net proceeds of $1.8 million from the exercise by the Meteora parties of Shortfall Warrants, as defined below, for 664,883 shares of Common Stock (see Note 9). The Company had cash of $5.3 million as of March 31, 2025.
Management believes that its existing cash balances combined with future capital raises through debt and equity and cash receipts from product sales will be sufficient to fund ongoing operations through at least one year from the date the condensed consolidated financial statements are issued. However, there can be no assurance that the Company will be successful in achieving its strategic plans, that the Company’s cash balances and future capital raises will be sufficient to support its ongoing operations, or that any additional financing will be available in a timely manner or on acceptable terms, if at all. If the Company is unable to raise sufficient financing when needed or events or circumstances occur such that the Company does not meet its strategic plans, the Company may be required to reduce certain of its discretionary spending. The Company may be unable to develop new or enhanced production methods, or be unable to fund capital expenditures, which could have a material adverse effect on the Company’s financial position, results of operations, cash flows, and ability to achieve its intended business objectives. These matters raise substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern and do not include adjustments to reflect the possible effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with U.S. 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 revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates and assumptions reflected in these condensed consolidated financial statements include but are not limited to the useful lives of property and equipment, the net realizable value of inventory, product warranty liability, stock-based compensation expense, the present value of the lease liability, the fair value of forward purchase agreement warrant liability, publicly traded warrant liability, and the outcome of litigation. Estimates and assumptions are reviewed periodically and the effect of changes, if any, are reflected in the condensed consolidated statements of operations and comprehensive loss.
Revisions
Cumulative Preferred Dividends
The Company corrected the presentation of cumulative preferred dividends that were not included on the previously issued condensed consolidated statement of operations and comprehensive loss for the three months ended March 31, 2024. The Company now presents these cumulative preferred dividends as a component of net loss attributable to common stockholders. The Company determined that the correction was not material to the three months ended March 31, 2024 and therefore, amendment of the previously filed reports is not required.
Contingent Sponsor Shares
The Company corrected the presentation of Common Stock outstanding that previously included 1,000,000 contingent sponsor shares that were included in the previously issued condensed consolidated statement of changes in stockholders’ deficit for the three months ended March 31, 2024. These contingent sponsor shares are now excluded from the number of shares of Common Stock outstanding as of March 31, 2024. The Company determined that the correction was not material to any prior annual or interim periods and therefore, amendments of previously filed reports are not required.
The effect of the contingent sponsor shares revision on the Common Stock amounts on each of the impacted financial statement line items within the Company’s condensed consolidated statement of changes in stockholders’ deficit for the three months ended March 31, 2024 was as follows:
| As Previously Reported | Adjustments | As Revised | |
|---|---|---|---|
| Balance at December 31, 2023 | 19,599,982 | (1,000,000) | 18,599,982 |
| Balance at March 31, 2024 | 19,599,982 | (1,000,000) | 18,599,982 |
Financing of Prepaid Insurance
The Company corrected the presentation of prepaid insurance expenses and insurance financing liabilities, including the related amortization and interest expense, that were not included on the previously issued condensed consolidated financial statements for the three months ended March 31, 2024. The Company determined that the correction was not material to any prior annual or interim periods and therefore, amendments of previously filed reports are not required.
The effect of the cumulative preferred dividends, contingent sponsor shares, and financing of prepaid insurance revisions on each of the impacted financial statement line items within the Company’s condensed consolidated statement of operations and comprehensive loss for the three months ended March 31, 2024 was as follows:
| As Previously Reported | Adjustments | As Revised | |
|---|---|---|---|
| General and administrative | $2,119 | $(14) | $2,105 |
| Total costs and operating expenses | 4,957 | (14) | 4,943 |
| Operating loss | (4,898) | 14 | (4,884) |
| Other expense, net | — | (14) | (14) |
| Total other income (expense), net | (1,372) | (14) | (1,386) |
| Cumulative preferred dividends | — | (1,365) | (1,365) |
| Net loss attributable to common stockholders, basic and diluted | $(6,270) | $(1,365) | $(7,635) |
| Net loss per share attributable to common stockholders, basic and diluted | $(0.32) | $(0.09) | $(0.41) |
| Weighted-average Class A Common Stock outstanding, basic and diluted | 19,599,982 | (1,000,000) | 18,599,982 |
The effect of the financing of prepaid insurance revision on the accumulated deficit amounts on each of the impacted financial statement line items within the Company’s condensed consolidated statement of changes in stockholders’ deficit for the three months ended March 31, 2024 was as follows:
| As Previously Reported | Adjustments | As Revised | |
|---|---|---|---|
| Balance at December 31, 2023 | $(257,242) | $(14) | $(257,256) |
| Balance at March 31, 2024 | $(264,877) | $(14) | $(264,891) |
The effect of the financing of prepaid insurance revision on each of the impacted financial statement line items within the Company’s condensed consolidated statement of cash flows for the three months ended March 31, 2024 was as follows:
| As Previously Reported | Adjustments | As Revised | |
|---|---|---|---|
| Amortization of prepaid insurance | $— | $270 | $270 |
| Prepaid expenses and other current assets | (43) | (13) | (56) |
| Net cash used in operating activities | (5,846) | 257 | (5,589) |
| Payments on insurance financing loans | — | (257) | (257) |
| Net cash provided by financing activities | 6,683 | (257) | 6,426 |
| Supplemental disclosures of cash flow information: | |||
| Cash paid for interest | $— | $14 | $14 |
| Non-cash investing and financing activities: | |||
| Financing of prepaid insurance | $— | $65 | $65 |
Concentration of Credit Risk and Significant Customers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and accounts receivable, net. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company maintains its cash with financial institutions that management believes to be of high credit quality. The Company has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
With respect to accounts receivable, the Company performs credit evaluations of its customers and does not require collateral. There have been no material losses on the Company’s accounts receivable. There were no customers that accounted for 10.0% or more of sales for the three months ended March 31, 2025 and 2024. There were no customers that accounted for 10.0% or more of the accounts receivable balance as of March 31, 2025 and December 31, 2024
Cash
The Company maintains cash balances in bank accounts which, at times, may exceed federally insured limits.
Accounts Receivable, Net
Accounts receivable are recorded at the invoiced amount and do not bear interest. The Company grants credit to customers in the normal course of business, but generally does not require collateral or other security to support amounts due. Accounts receivable are presented net of an allowance for credit losses. Management performs ongoing credit evaluations of its customers based on financial information provided by the customer. Accounts receivable outstanding longer than the contractual payment terms are considered past due. The Company estimates its allowance for credit losses by considering numerous factors, including delinquency trends along with ongoing customer credit evaluations. The Company writes off accounts receivable when they become uncollectible. Payments subsequently received on such receivables are credited to the allowance for credit losses. The Company had no material bad debt expense for the three months ended March 31, 2025 and 2024. The allowance for credit losses was not material as of March 31, 2025 and December 31, 2024.
Inventories
Inventories are stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. The Company records write-downs of inventories that are obsolete, past the manufacturer’s recommended ‘use by’ date, or in excess of anticipated demand or net realizable value based on a consideration of marketability and product life cycle stage, historical net sales and demand forecasts which consider the assumptions about future demand and market conditions. Inventory on hand that is not expected to be sold or utilized is considered excess, and the Company recognizes the write-down in cost of goods sold at the time of such determination. The write-down is determined by the excess of cost over net realizable value. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable cost of completion, disposal and transportation. At the time of loss recognition, a new cost basis is established and subsequent changes in facts and circumstances would not result in an increase in the cost basis.
Property and Equipment, Net
Property and equipment are stated at cost, net of accumulated depreciation. Additions and improvements that extend the lives of the assets are capitalized, while expenditures for repairs and maintenance are expensed as incurred. When assets are retired or otherwise disposed of, their costs and related accumulated depreciation are removed from the accounts and resulting gains or losses are included in operating results. Depreciation is calculated using the straight-line method over the estimated useful life of the asset, which ranges from three toseven years for property and equipment.
Operating Leases
The Company determines if an agreement is a lease at inception. The Company elected not to recognize the right to use an underlying asset (“ROU asset”) and lease liabilities for short-term leases, which are those that have a lease term oftwelve months or less, and includes renewal options in the measurement of lease liabilities only when the option to purchase or renew a lease for the underlying asset is reasonably certain to be exercised. The Company has elected as an accounting policy to account for lease components and associated non-lease components as a single component.
The Company leases its headquarters office space under an operating lease with a related party and also leases office space in Germany under an operating lease (see Note 6). The determination of whether an arrangement is, or contains, a lease is performed at the inception of the arrangement and as necessary at modification. An operating lease is recorded on the condensed consolidated balance sheets with the operating lease asset representing the right to use the ROU asset for the lease term and the lease liability representing the obligation to make lease payments arising from the lease. The Company excludes variable lease payments when measuring the ROU asset and lease liability, except for those that depend on an index, a rate or are in-substance fixed payments.
ROU assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. In addition, ROU assets include initial direct costs incurred by the lessee as well as any lease payments made at or before the commencement date and exclude lease incentives. The discount rate implicit within the Company’s leases is generally not determinable; therefore, the Company determines the discount rate using its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments.
Impairment of Long-Lived Assets
Long-lived assets held and used by the Company, including property and equipment and ROU assets, are reviewed for impairment whenever events or changes in business circumstances indicate that the carrying amount of an asset may not be recoverable. An asset should be tested for recoverability by comparing the carrying value of the asset to the entity-specific undiscounted net cash flows of that asset. If the carrying amount of an asset is not recoverable, an impairment loss is recognized if the asset’s carrying value exceeds its fair value. The Company did not incur any impairment charges for the three months ended March 31, 2025 and 2024.
Fair Value of Financial Instruments
The Company calculates the fair value of its assets and liabilities that qualify as financial instruments and includes this additional information in the notes to the condensed consolidated financial statements when the fair value is different than the carrying value of these financial instruments. The estimated fair value of cash, accounts receivable, other receivable, prepaid expenses and other current assets, accounts payable, and accrued expenses approximate their carrying amounts due to the relatively short maturity of these instruments. The carrying value of the operating lease liability also approximates fair value since the instrument is recorded utilizing market rates of interest. The carrying value of the term loans payable also approximates fair value based upon current borrowing rates with similar maturities. None of these instruments are held for trading purposes.
Fair Value Measurement
The Company determines the fair value of financial assets and liabilities using the fair value hierarchy established in Accounting Standards Codification (“ASC”) Topic 820,Fair Value Measurement (“ASC 820”). ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. The hierarchy describes three levels of inputs that may be used to measure fair value, as follows:
| ● | Level 1 - Observable inputs, such as quoted prices in active markets for identical assets and liabilities. |
| ● | Level 2 - Observable inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
| ● | Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company’s forward purchase agreement warrant liability is considered to be a Level 3 financial instrument measured at fair value and is described below (see Note 3).
Derivative Financial Instruments
The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign-currency risks. The Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with ASC Topic 815,Derivatives and Hedging (“ASC 815”). For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value on the grant date and is then re-valued at each reporting date, with changes in the fair value reported in the other income (expense) section of the Company’s condensed consolidated statements of operations and comprehensive loss. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities are classified in the condensed consolidated balance sheets as current or non-current based on whether or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date.
The Company accounts for its publicly traded warrant liability in accordance with ASC 815-40. Accordingly, the Company recognized the warrant instruments as a liability at fair value and adjusts the instruments to fair value at each reporting period. The publicly traded warrant liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized in the change in fair value of publicly traded warrant liability line item in the Company’s condensed consolidated statements of operations and comprehensive loss.
The Company accounts for its Forward Purchase Agreement in accordance with ASC 815-40. Accordingly, the Company recognized the forward purchase agreement warrant liability at fair value at each reporting period. The forward purchase agreement put option liability was, and the forward purchase agreement warrant liability is, subject to re-measurement at each balance sheet date, and any change in fair value is recognized in the change in fair value of forward purchase agreement put option liability and change in fair value of forward purchase agreement warrant liability line items, respectively, in the Company’s condensed consolidated statements of operations and comprehensive loss. The forward purchase agreement put option liability was derecognized as of March 31, 2024 due to the sale of the Recycled Shares associated with the forward purchase agreement during the first quarter of 2024.
SPAC Excise Tax Liability
The Company recognized an excise tax liability of $2.2 million upon completion of the Company’s Business Combination as an incremental cost to repurchase the Company’s treasury shares, with an offsetting tax liability recognized. The SPAC excise tax liability is recorded in accrued expenses in the Company’s condensed consolidated balance sheets.
Revenue Recognition
The Company recognizes revenue in accordance with ASC Topic 606,Revenue from Contracts with Customers, which provides a five-step model for recognizing revenue from contracts with customers as follows:
| ● | identify the contract with a customer; |
| ● | identify the performance obligations in the contract; |
| ● | determine the transaction price; |
| ● | allocate the transaction price to the performance obligations in the contract; and |
| ● | recognize revenue when or as performance obligations are satisfied. |
Revenue is recognized as performance obligations under the terms of a contract are satisfied, which generally occurs as control of the promised products or services is transferred to customers. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer (“transaction price”). To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price using either the expected value or most likely amount method. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information that is reasonably available.
The Company primarily derives revenue from the sale of its hearing device products. Revenue from product sales is recognized upon transfer of control of the product to a customer, which occurs at a point in time, at the time the Company is notified the product has been implanted or used by the customer in a surgical procedure. The Company also sells prepaid battery replacement options, which is replacement of the sound processor / battery assembly (the “Battery”) for existing patients who need a new Battery.
Revenue from extended warranty plans is recognized ratably over time and was immaterial for each of three months ended March 31, 2025 and 2024. Amounts received from a customer prior to fulfillment of the performance obligation are included as accrued expenses on the condensed consolidated balance sheets and are immaterial as of March 31, 2025 and December 31, 2024. The Company has elected to account for shipping and handling activities performed as activities to fulfill the promise to transfer the products; and therefore these activities are not assessed as a separate performance obligation to its customers.
Revenue is measured as the amount of consideration the Company expects to receive, which is based on the invoiced price. The majority of the Company’s contracts have a single performance obligation and are short term in nature. The Company’s contracts do not include variable consideration.
Payment terms differ by geography and customer, but payment is generally required within 30 days from the date of product utilization. The Company also offers extended payment plans on a limited basis. Amounts due to the Company under payment plans that extend beyond 12 months are immaterial as of March 31, 2025 and December 31, 2024, and therefore the Company did not adjust the promised amount of consideration for the effects of a significant financing component.
Cost of Goods Sold
Cost of goods sold is comprised of the costs of merchandise sold, as well as the related inbound freight costs and labor directly attributable to bringing certain goods to a salable condition. In categorizing costs, the Company captures applicable depreciation and costs to maintain and run revenue generating technology, equipment related costs and any personnel-related costs as cost of goods sold.
Product Warranty
The Company provides a limited warranty for its implantable components. At the time product revenue is recognized, the Company reserves for estimated future costs that may be incurred under its warranties based on historical experience. The limited warranty liability is recorded in accrued expenses in the condensed consolidated balance sheets. As of March 31, 2025 and December 31, 2024, the amount of accrued limited warranty was immaterial and the Company’s warranty payments were immaterial.
During 2013, the Company offered a lifetime warranty to clinical trial patients to cover batteries and surgery related costs. The Company estimates the costs that may be incurred under this lifetime warranty and records a liability in the amount of such costs at its present value. The lifetime warranty is recorded in product warranty liability in the condensed consolidated balance sheets. As of March 31, 2025 and December 31, 2024, the aggregate product warranty liability was $2.0 million and $2.1 million, respectively, of which $0.3 million and $0.3 million, respectively, was classified as a current liability in the condensed consolidated balance sheets.
Patents
All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses.
Research and Development Costs
Expenditures for research and development activities are charged to operations as incurred. Research and development costs include salaries, employee benefits and laboratory testing expenses. Expenses related to clinical trials will be based on costs incurred pursuant to contracts with research institutions that are used to conduct and manage clinical trials on the Company’s behalf.
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax base and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those items are expected to be recovered or settled. The Company has recorded a full valuation allowance against the net deferred tax asset due to the uncertainty of realizing the related benefits.
The Company recognizes the financial statement benefit of a tax position only to the extent the position is more likely than not to be sustained upon audit based on the technical merits of the position. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the Company*’*s condensed consolidated financial statements is the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the relevant tax authority. The Company has elected to recognize interest and penalties related to uncertain tax positions in the provision for income taxes.
As of March 31, 2025 and December 31, 2024, the Company recorded an uncertain tax benefit within other liability on the condensed consolidated balance sheet in the amount of $0.1 million resulting from a refund remitted to the Company related to payments and carryforwards reported by Anzu on its final tax return prior to the Business Combination on September 29, 2023.
Subsequently in the fourth quarter of 2024, the Company also received a notice from the Internal Revenue Service (“IRS”) indicating an additional refund of $0.8 million was to be remitted to the Company, which was received in the first quarter of 2025. This refund is also considered to be the result of estimated tax payments made by Anzu as reported on its short period tax return filed for the period January 1, 2023 to September 29, 2023, prior to the Business Combination. The Company is uncertain whether the IRS treated the transaction as an IRC 368(a)(1)(F) reorganization (“F reorganization”) or as an IRC 368(a)(1)(A) reorganization (“A reorganization”). During the three months ended March 31, 2025, the Company received this refund in the amount of $0.8 million. The Company has determined that it is appropriate to retain the funds, under the premise that the transaction was treated as an F reorganization rather than an A reorganization, however, given the uncertainty of that outcome, the Company has recorded an uncertain tax position liability recorded within other liability on the condensed consolidated balance sheets as of March 31, 2025 and December 31, 2024.
Foreign Currency Translation
The Euro is the functional currency for the Company’s foreign subsidiary in Germany. The assets and liabilities of the Company’s foreign operations are translated into U.S. dollars at the end-of-the-period exchange rates, and the revenues and expenses are translated at weighted-average rates for the respective reporting period. Unrealized translation gains and losses are recorded as a translation adjustment, which is included in the Company’s condensed consolidated statements of changes in stockholders’ deficit as well as a component of accumulated other comprehensive loss on the Company’s condensed consolidated statements of operations and comprehensive loss.
Net Loss per Share
The Company’s Series A Preferred Stock certificate of designation entitles the holders to participate in dividends on an as converted basis when declared on Common Stock. As a result, the Series A Preferred Stock meets the definition of a participating security, which requires the Company to apply the two-class method to compute both basic and diluted net loss per share attributable to common stockholders. The two-class method is an earnings allocation formula that treats participating securities as having rights to earnings that would otherwise have been available to common stockholders. The two-class method requires income available to holders of the Company’s Common Stock for the period to be allocated between common and participating securities based upon their respective rights to share in the earnings as if all income for the period had been distributed. In periods where there is a net loss, no allocation of undistributed net loss to the Series A Preferred Stock is performed as the holders of the Series A Preferred Stock are not contractually obligated to participate in the Company’s losses. The Company reported net losses of $6.2 million and $7.6 million attributable to the stockholders of the Company’s Common Stock for the three months ended March 31, 2025 and 2024, respectively.
Basic net loss per share of common stock is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares outstanding, plus the impact of potential common shares, if dilutive, resulting from the potential exercise of warrants or options, and the potential conversion of preferred stock into Common Stock, under the if-converted method. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, because the effect would be anti-dilutive.
Stock-based Compensation
Stock-based compensation is measured at the grant date, based on the fair value of the award, and is recognized as an expense over the requisite service period. The fair value of stock-based payment awards granted through June 30, 2024 is estimated using the Black-Scholes option model with a volatility figure derived from using a determined peer group of other companies’ stock prices since the trading history of the Company’s stock was too short to provide accurate data. The fair value of stock-based payment awards granted subsequent to June 30, 2024 is estimated using the Black-Scholes option model with a volatility figure derived from using the trading history of the Company’s Common Stock. Given limited historical exercise data, the Company accounts for the expected term of all options in all periods in accordance with the “simplified” method, which is used for “plain-vanilla” options, as defined in ASC Topic 718,Compensation - Stock Compensation. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options. The risk-free interest rate was determined from the implied yields of U.S. Treasury zero-coupon bonds with a remaining life consistent with the expected term of the options.
The Company has adopted the guidance from Accounting Standards Update (“ASU”) 2016-09,Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Compensation Accounting, and has determined not to apply a forfeiture rate and has made the accounting election that forfeitures will be recognized when the actual forfeiture takes place and therefore no estimated forfeiture rate will be recorded.
Segments
Operating segments are identified as components of an enterprise about which discrete financial information is available for evaluation by the chief operating decision-maker (“CODM”) in deciding resource allocation and assessing performance. The Company has determined that its CODM is its Chief Executive Officer. The Company’s CODM reviews financial information presented on a consolidated basis for the purposes of making decisions, allocating resources and evaluating performance. Consequently, the Company has determined it operates inone operating and reportable segment.
Recently Adopted Accounting Pronouncements
In August 2020, the Financial Accounting Standards Board (“FASB”) issued ASU 2020-06,Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify certain financial instruments. ASU 2020-06 eliminates the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for all convertible instruments. For smaller reporting companies, ASU 2020-06 is effective for fiscal years beginning after December 15, 2023 and should be applied on a full or modified retrospective basis. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company adopted ASU 2020-06 effective January 1, 2024. The adoption of ASU 2020-06 did not have a material impact on the Company’s condensed consolidated financial statements.
In November 2023, the FASB issued ASU 2023-07,Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures(“ASU 2023-07”), which will add required disclosures of significant expenses for each reportable segment, as well as certain other disclosures to help investors understand how the CODM evaluates segment expenses and operating results. The new standard will also allow disclosure of multiple measures of segment profitability if those measures are used to allocate resources and assess performance. The Company adopted ASU 2023-07 effective for the year ended December 31, 2024. See Note 12 for related disclosures.
Accounting Pronouncements Not Yet Effective
In December 2023, the FASB issued ASU 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. The standard is intended to benefit investors by providing more detailed income tax disclosures that would be useful in making capital allocation decisions. The standard will be effective for public companies for fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact that ASU 2023-09 will have on the Company’s disclosures within its condensed consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03,Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), that requires public companies to disclose, in interim and reporting periods, additional information about certain expenses in the financial statements. For public business entities, it is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and is effective on either a prospective basis or retrospective basis. The Company is currently evaluating the impact that ASU 2024-03 will have on the Company’s disclosures within the condensed consolidated financial statements.
3. Fair Value Measurements
The following tables provide information related to the Company’s assets and liabilities measured at fair value on a recurring basis as of March 31, 2025 and December 31, 2024 (in thousands):
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Liabilities: | ||||
| Forward purchase agreement warrant liability | $— | $— | $51 | $51 |
| Publicly traded warrant liability | 468 | — | — | 468 |
| $468 | $— | $51 | $519 | |
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Liabilities: | ||||
| Forward purchase agreement warrant liability | $— | $— | $472 | $472 |
| Publicly traded warrant liability | 662 | — | — | 662 |
| $662 | $— | $472 | $1,134 | |
The fair value of the forward purchase agreement warrant liability is a Level 3 fair value measurement, and was estimated using Monte Carlo simulation models. The use of significant unobservable inputs could result in those inputs being different at the reporting dates and which could result in a significantly higher or lower fair value measurement at the reporting dates. The following table presents the quantitative information regarding Level 3 fair value measurements of the forward purchase agreement warrant liability as of March 31, 2025 and December 31, 2024:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Stock price | $1.30 | $1.43 |
| Initial exercise price | $10.46 | $10.46 |
| Annual volatility | 89.0% | 130.0% |
| Remaining term (in years) | 0.75 | 1.00 |
| Risk-free rate | 4.05% | 4.08% |
The Company has classified the publicly traded warrant liability within Level 1 of the hierarchy as the warrant is separately listed and traded in an active market. The publicly traded warrant’s listed price in an active market was used as the fair value.
The following table summarizes the activity for the Company’s Level 3 instruments measured at fair value on a recurring basis (in thousands):
| Forward Purchase Agreement Warrant Liability | |
|---|---|
| Balance as of December 31, 2024 | $472 |
| Change in fair value | (421) |
| Balance as of March 31, 2025 | $51 |
There were no transfers between Level 1 and Level 2, nor into and out of Level 3, during the periods presented.
4. Inventories
Inventories, consisted of the following (in thousands):
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Raw materials | $1,439 | $1,386 |
| Work-in-progress | 54 | 203 |
| Finished goods | 164 | 119 |
| $1,657 | $1,708 |
5. Property and Equipment, Net
Property and equipment consisted of the following (in thousands):
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Lab equipment | $3,106 | $3,106 |
| Production equipment | 2,249 | 2,249 |
| Computer equipment | 654 | 648 |
| Office equipment | 102 | 102 |
| Total | 6,111 | 6,105 |
| Less: Accumulated depreciation | (4,891) | (4,830) |
| Property and equipment, net | $1,220 | $1,275 |
Depreciation expense was less than $0.1 million for the three months ended March 31, 2025 and 2024.
6. Operating Leases
The Company leases its headquarters office space in Minnesota and leases office space in Germany. The headquarters office space lease is with a stockholder, which is considered a related party. During the year ended December 31, 2024, the Company and the landlord agreed to modify the lease to extend the lease term for three (3) additional years through December 31, 2030. Additionally, the Company requested and the landlord provided an additional 1,664 square feet of usable office space, for a total of 11,540 square feet of rentable space. Accordingly, base rent was increased to $6 thousand per month and increases each year by approximately four percent. Also, tenant improvements completed by the landlord totaling $0.15 million will be repaid in three $50 thousand annual payments beginning July 1, 2027. As a result of the modification, the Company recognized an increase to the ROU asset and operating lease liability of $0.5 million.
The lease of the office space in Germany is not with a related party and is immaterial.
The components of leases and lease costs were as follows (in thousands):
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Operating lease right-of-use asset (related party) | $853 | $879 |
| Operating lease liability, current portion (related party) | $145 | $143 |
| Operating lease liability, net of current portion (related party) | 778 | 802 |
| $923 | $945 |
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Operating lease cost | $51 | $97 |
| $51 | $97 | |
Other supplemental information of lease amounts recognized in the condensed consolidated financial statements is summarized as follows:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Cash paid for amounts included in the measurement of lease liability | $45 | $113 |
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Weighted-average remaining lease term - in years | 5.8 | 6.0 |
| Weighted-average discount rate | 9.9% | 9.9% |
Future minimum lease payments associated with these leases were as follows as of March 31, 2025 (in thousands):
| 2025 (remaining) | $185 |
| 2026 | 223 |
| 2027 | 230 |
| 2028 | 195 |
| 2029 | 198 |
| Thereafter | 151 |
| Less: Imputed interest | (259) |
| $923 |
7. Product Warranty Liability
Changes in warranty liability were as follows (in thousands):
| Amount | |
|---|---|
| Balance as of December 31, 2024 | $2,053 |
| Utilization | (17) |
| Balance at March 31, 2025 | $2,036 |
The assumptions utilized in developing the liability as of March 31, 2025 include an estimated cost per unit of $6 thousand, an average Battery life offive years, inflationary increase of 3.8%, and an average patient life calculated based on probabilities outlined in the PRI-2012 mortality tables, published from the Society of Actuaries. Additionally, a discount rate of 5.2% was used in the calculation as of March 31, 2025.
8. Debt (Related Party)
Term Loans
In February 2024, the Company issued a promissory note (the “February 2024 Term Loan”) with a minimum principal amount of $5.0 million and up to $10.0 million to GAT Funding, LLC (“GAT”), an entity controlled by Glen A. Taylor, a member of the Company’s board of directors and a controlling stockholder of the Company. At closing, the Company drew down $5.0 million from the February 2024 Term Loan. Provided that no event of default had occurred and the Company submitted a request for funding certifying that the Company had less than $7.5 million of net tangible assets, the Company had the ability to draw the remaining $5.0 million in $2.5 million tranches, as long as each request was made prior to February 1, 2025. In both May 2024 and July 2024, the Company requested and received additional advances of $2.5 million under the February 2024 Term Loan. As of March 31, 2025, the balance outstanding on the February 2024 Term Loan was $9.5 million, net of discount.
The February 2024 Term Loan has a five-year term and matures on February 27, 2029. The principal amount drawn bears interest at a rate of 8.0% per annum and is paid quarterly in arrears after the second anniversary of the February 2024 Term Loan. Interest will accrue and is not payable for the firsttwo years of the term and will compound and be added to the principal balance of the February 2024 Term Loan both on the first and second anniversary of the February 2024 Term Loan. The Company may prepay the accrued interest and principal of the February 2024 Term Loan without penalty, with 10 days’ notice.
In August 2024, the Company issued an additional promissory note (the “August 2024 Term Loan”) with a principal amount of up to $10.0 million to GAT. At closing, the Company drew down $5.0 million from the August 2024 Term Loan. Provided that no event of default had occurred and the Company submitted a request for funding certifying that the Company had less than $7.5 million of net tangible assets, the Company had the ability to draw the remaining $5.0 million in $2.5 million tranches, as long as each request is made prior to August 1, 2025. In December 2024, the Company requested and received an additional advance of $5.0 million under the August 2024 Term Loan. As of March 31, 2025, the balance outstanding on the August 2024 Term Loan was $9.3 million, net of discount.
The August 2024 Term Loan has a five-year term and matures on August 27, 2029. The principal amount drawn bears interest at a rate of 8.0% per annum and is paid quarterly in arrears after the second anniversary of the August 2024 Term Loan. Interest will accrue and is not payable for the firsttwo years of the term and will compound and be added to the principal balance of the August 2024 Term Loan both on the first and second anniversary of the August 2024 Term Loan. The Company may prepay the accrued interest and principal of the August 2024 Term Loan without penalty, with 10 days’ notice.
As a commitment fee, the Company was required to issue warrants to purchase 250,000 shares of its Common Stock for each $2.5 million of principal funded under the February 2024 Term Loan and August 2024 Term Loan. The warrants have an exercise price equal to the closing price on the date of funding of the applicable tranche.
At closing of the initial funding of the February 2024 Term Loan, the Company issued warrants to purchase 500,000 shares of Common Stock at an exercise price of $1.24 per share. These warrants expire on February 27, 2026. Upon the second draw made in May 2024, the Company issued warrants to purchase 250,000 shares of Common Stock at an exercise price of $3.04 per share. These warrants expire on February 28, 2026. Upon the third draw made in July 2024, the Company issued warrants to purchase 250,000 shares of Common Stock at an exercise price of $2.25 per share. These warrants expire on July 23, 2026.
At closing of the initial funding of the August 2024 Term Loan, the Company issued warrants to purchase 500,000 shares of Common Stock at an exercise price of $2.97 per share. These warrants expire on August 27, 2026. Upon the second draw made in December 2024, the Company issued warrants to purchase 500,000 shares of Common Stock at an exercise price of $2.20 per share. These warrants expire on December 11, 2026.
In March 2025, the Company issued a promissory note (the “March 2025 Term Loan” and, collectively with the February 2024 Term Loan and August 2024 Term Loan, the “Term Loans”) with a minimum principal amount of $5.0 million and up to $10.0 million to GAT. At closing, the Company drew down $5.0 million from the March 2025 Term Loan. Provided that no event of default has occurred and the Company submits a request for funding certifying that the Company has less than $7.5 million of net tangible assets, the Company has the ability to draw the remaining $5.0 million in $2.5 million tranches, as long as each request is made prior to March 2026. As of March 31, 2025, the balance outstanding on the March 2025 Term Loan was $4.3 million, net of discount.
The March 2025 Term Loan has a five-year term and matures on March 6, 2030. The principal amount drawn bears interest at a rate of 8.0% per annum and is paid quarterly in arrears after the second anniversary of the March 2025 Term Loan. Interest will accrue and is not payable for the firsttwo years of the term and will compound and be added to the principal balance of the March 2025 Term Loan both on the first and second anniversary of the March 2025 Term Loan. The Company may prepay the accrued interest and principal of the March 2025 Term Loan without penalty, with 10 days’ notice.
As a commitment fee, the Company will issue warrants to purchase 375,000 shares of its Common Stock for each $2.5 million of principal funded under the March 2025 Term Loan. The warrants will have an exercise price equal to the closing price on the date of funding of the applicable tranche and a termination date as of the third anniversary of the initial closing for all warrants. At closing of the initial funding, the Company issued GAT warrants to purchase 750,000 shares of Common Stock at an exercise price of $1.35 per share.
The Term Loans were accounted for as a conventional debt instrument and are accounted for in accordance with ASU 2020-06*.*
As a result of the issuance of the warrants with the initial closing of the February 2024 Term Loan, which met the criteria for equity classification under applicable U.S. GAAP, the Company recorded the fair value of the warrants on the issuance date in the amount of $0.2 million as a debt discount and additional paid-in capital on the condensed consolidated balance sheets. As a result of the additional draws made in May 2024 and July 2024, the Company recorded the fair value of the additional warrants in the amount of $0.2 million and $0.2 million, respectively, as debt discounts and additional paid-in capital. Subsequently, these debt discounts are being recorded to interest expense, related party over the term of the February 2024 Term Loan.
As a result of the issuance of the warrants with the initial closing of the August 2024 Term Loan, which met the criteria for equity classification under applicable U.S. GAAP, the Company recorded the fair value of the warrants on the issuance date in the amount of $0.5 million as a debt discount and additional paid-in capital on the condensed consolidated balance sheets. As a result of the additional draw made in December 2024, the Company recorded the fair value of the additional warrant in the amount of $0.3 million as a debt discount and additional paid-in capital. Subsequently, these debt discounts are being recorded to interest expense, related party over the term of the August 2024 Term Loan.
As a result of the issuance of the warrants with the initial closing of the March 2025 Term Loan, which met the criteria for equity classification under applicable U.S. GAAP, the Company recorded the fair value of the warrants on the issuance date in the amount of $0.7 million as a debt discount and additional paid-in capital on the condensed consolidated balance sheets. Subsequently, this debt discount is being recorded to interest expense, related party over the term of the March 2025 Term Loan.
The Company uses the Black-Scholes option model to estimate the fair value of warrants issued in connection with the Term Loans. In applying the Black-Scholes option model, the Company used the following assumptions in the valuation of warrants issued during the three months ended March 31, 2025 and 2024:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Risk-free rate | 3.9% | 4.6% |
| Expected dividend yield | — | — |
| Expected term (years) | 2.0 | 1.8 |
| Expected volatility | 136.0% | 42.4% |
| Stock price | $1.35 | $3.05 |
The Company uses a present value calculation of future cash flows to estimate the fair value of the Term Loans at the date of issuance. The Company used the following inputs in the valuation of Term Loans issued during the three months ended March 31, 2025 and 2024:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Principal | $5,000,000 | $5,000,000 |
| Coupon rate | 8.0% | 8.0% |
| Issuance date | 3/6/2025 | 2/27/2024 |
| Interest type | Fixed - rate | Fixed - rate |
| Payment frequency | Maturity | Maturity |
| Interest day count | Actual / 365 | Actual / 365 |
| Maturity | 3/6/2030 | 2/27/2029 |
| Market rate (1) | 11.7% | 7.8% |
(1)Discounted using the interpolated S&P CCC yield curve commensurate with the remaining term of the note.
During the three months ended March 31, 2025 and 2024 the Company recognized $0.5 million and less than $0.1 million, respectively, of interest expense in relation to the Term Loans, at effective interest rate ranging from 9.66% to 12.41%. Included within this interest expense total, the Company recognized $012 million and less than $0.1 million of debt discount amortization during the three months endd March 31, 2025 and 2024, respectively. As of March 31, 2025 and December 31, 2024, accrued interest of $1.1 million and $0.7 million, respectively, is recorded in accrued expenses and unamortized debt discount of $1.9 million and $1.3 million, respectively, is recorded within term loans payable (related party) on the Company’s condensed consolidated balance sheets.
9. Common Stock
As of March 31, 2025 and 2024, the Company was authorized to issue 400,000,000 shares of Common Stock. The voting, dividend and liquidation rights of the holders of the Company’s Common Stock are subject to and qualified by the rights, powers and preferences of the holders of the Series A Preferred Stock (see Note 10).
Contingent Sponsor Shares
Pursuant to the sponsor support and forfeiture agreement dated April 17, 2023 by and between Anzu, Envoy Medical Corporation and the Sponsor, as amended or modified from time to time (the “Sponsor Support Agreement”), and as of the date of issuance,1,000,000 shares of Common Stock held by the Sponsor were unvested and subject to the restrictions and forfeiture provisions set forth in the Sponsor Support Agreement (the “Contingent Sponsor Shares”). The Contingent Sponsor Shares were to vest upon the FDA’s approval of the Acclaim CI (the “FDA Approval”). If a change of control of the Company occurred following the Closing, then the conditions for vesting of any Contingent Sponsor Shares that remain unvested as of immediately prior to the consummation of the change of control were to be deemed to have been achieved and such Contingent Sponsor Shares would have immediately vested as of immediately prior to the consummation of such change of control.
As of December 20, 2024 the Company and the Sponsor entered into an agreement to remove the vesting restriction on the Contingent Sponsor Shares, more fully described in Note 10 under “Sponsor Induced Conversion”.
Outstanding Warrants
The following table summarizes the Company’s outstanding warrant activity for the three months ended March 31, 2025 (in number of warrant shares):
| Shortfall Warrants | Publicly Traded Warrants | Term Loan Warrants | |
|---|---|---|---|
| December 31, 2024 | 3,209,511 | 14,166,666 | 2,000,000 |
| Issued | — | — | 750,000 |
| Exercised | — | — | — |
| Forfeited | — | — | — |
| March 31, 2025 | 3,209,511 | 14,166,666 | 2,750,000 |
Term Loan Warrants
During the three months ended March 31, 2025 and 2024, the Company issued warrants to purchase 750,000 and 500,000 shares, respectively, of its Common Stock to a related party in conjunction with the Term Loans (see Note 8) (the “Term Loan Warrants”). The Term Loan Warrants are all outstanding as of March 31, 2025.
Forward Purchase Agreement Warrant Liability
Pursuant to the terms of the Forward Purchase Agreement, the Company issued to the Meteora parties warrants to purchase 3,874,394 shares of Common Stock (the “Shortfall Warrants”). As issued, the Shortfall Warrants had an exercise price determined based on the volume weighted average price of the Common Stock, subject to a $4.00 price floor (the “Exercise Price Floor”), which Exercise Price Floor is adjustable for certain issuances of Common Stock at a price below the then-current Exercise Price Floor. The Shortfall Warrants had an expiration date of June 30, 2024 upon issuance. The fair value of the Shortfall Warrants is presented in the forward purchase agreement warrant liability line on the condensed consolidated balance sheets. The change in fair value of the Shortfall Warrants each period is recorded within the change in fair value of forward purchase agreement warrant liability line on the condensed consolidated statements of operations and comprehensive loss.
On June 24, 2024, the Company and the Meteora parties entered into Amendment No. 1 to the Shortfall Warrants to extend the expiration of the Shortfall Warrants to December 31, 2024. On July 29, 2024, the Company and the Meteora parties entered into an amendment to adjust the Exercise Price Floor of certain Shortfall Warrants from $4.00 to $2.00 for 1,000,000 of the Shortfall Warrants, $3.00 for an additional 1,000,000 Shortfall Warrants, and with remainder of the Shortfall Warrants retaining the $4.00 Exercise Price Floor. On December 19, 2024, the Company and the Meteora parties entered into Amendment No. 2 to the Shortfall Warrants to extend the expiration date of the Shortfall Warrants to December 31, 2025.
During the three months ended March 31, 2025 and 2024, the Meteora parties did not exercise any Shortfall Warrants. As of March 31, 2025, Shortfall Warrants to purchase 3,209,511 shares of Common Stock remained outstanding.
10. Series A Preferred Stock
As of March 31, 2025 and December 31, 2024, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue 100,000,000 shares of $0.0001 par value preferred stock, of which 10,000,000 shares have been designated as Series A Preferred Stock.
Pursuant to a convertible promissory note, dated April 17, 2023, between Envoy Medical Corporation and GAT (the “Envoy Bridge Note”), the Sponsor Support Agreement and the Subscription Agreement, the Company has outstanding an aggregate of 4,126,667 shares of Series A Preferred Stock as of March 31, 2025 and December 31, 2024, respectively, originally issued to the following investors:
| ● | 1,000,000 shares of Series A Preferred Stock to GAT pursuant to the Envoy Bridge Note; |
| ● | 2,500,000 shares of Series A Preferred Stock to the Sponsor pursuant to the Sponsor Support Agreement; and |
| ● | 1,000,000 shares of Series A Preferred Stock to certain affiliates of the Sponsor in the PIPE Transaction pursuant to the Subscription Agreement. |
As described subsequently in this note, on December 20, 2024, the Company entered into a Conversion and Waiver Agreement with the Sponsor whereby 373,333 shares of Series A Preferred Stock were converted into Common Stock.
The holders of the Series A Preferred Stock have the following rights and preferences:
Voting Rights
The holders of the Series A Preferred Stock are not entitled to vote or receive notice of any meeting of stockholders, except in the case that the Company creates any equity or debt instrument that ranks senior or pari passu to the rights of the Series A Preferred Stock or in the case of any adverse change to the powers, preferences or special rights of the Series A Preferred Stock.
Conversion Rights
Each share of Series A Preferred Stock shall be convertible, at the option of the holder, at any time after the date of issuance into such number of shares of Common Stock as determined by dividing the issuance price of the shares of Series A Preferred Stock of $10.00, by the conversion price, which was $11.50 per share as of March 31, 2025 and is adjustable for certain dilutive events.
Redemption
The holders of Series A Preferred Stock are not entitled to any redemption rights, other than those under their liquidation rights discussed below. The Company does not have the option to redeem the Series A Preferred Stock.
Dividend Rights
The holders of Series A Preferred Stock are entitled to a cumulative dividend which accrues at the rate of 12% of the original issuance price of $10.00 per share per annum (“Regular Dividend”). The Regular Dividend accrues on a daily basis from and including the issuance date of such shares, whether or not declared, and will be payable in cash on a quarterly basis. If the Company fails to pay the Regular Dividends on the dividend payment date, then an additional dividend on the amount of the unpaid portion shall automatically accrue at 12%.
The holders of Series A Preferred Stock are also entitled to dividends or distributions (“Participating Dividends”) senior to Common Stock of the Company when such dividends are declared. There wereno Participating Dividends declared as of March 31, 2025 and December 31, 2024.
Specifically pursuant to the 2,500,000 shares of Series A Preferred Stock issued subject to the Sponsor Support Agreement, any dividends arising will accrue and not require timely payment at any time when the Company has less than $10.0 million of net tangible assets. During the three months ended March 31, 2025 and 2024, the Company did not meet the $10.0 million net tangible asset requirement and deferred payment on the dividends related to the $2.5 million of Series A Preferred Stock shares held by the Sponsor. As of March 31, 2025 and December 31, 2024, the Company had accrued $0.7 million and $0.1 million, respectively, in unpaid dividends as a result of the Sponsor Support Agreement.
With respect to the holders of the Series A Preferred Stock other than the Series A Preferred Stock subject to the Sponsor Support Agreement held by the Sponsor, the Company had accrued zero and $0.5 million as of March 31, 2025 and December 31, 2024, respectively, in unpaid Regular Dividends.
Liquidation Preference
In the event of any liquidation, deemed liquidation, dissolution or winding up of the Company, whether voluntary or involuntary, the holders of the Series A Preferred Stock are entitled to receive, prior and in preference to any distribution of any of the assets or surplus funds of the Company to the holders of any security of the Company that ranks junior to the Series A Preferred Stock, including, but not limited to, the Common Stock, an amount per share of Series A Preferred Stock equal to the greater of i) $10.00 plus any unpaid cash dividends and ii) the amount the holder would have received, if such holder, immediately prior to such involuntary liquidation, dissolution or winding up of Company, had converted such shares of Series A Preferred Stock into Common Stock.
Sponsor Induced Conversion
On December 20, 2024 (the “Effective Date”), the Company entered into a Conversion and Waiver Agreement (the “Conversion Agreement”) with the Sponsor.
As of the Effective Date of the Conversion Agreement, Sponsor was the holder of 2,500,000 shares of the Company’s Series A Preferred Stock and the Contingent Sponsor Shares. The Contingent Sponsor Shares were unvested and subject to certain restrictions and risk of forfeiture under the Sponsor Support Agreement until certain milestones were achieved. Pursuant to the terms of the Sponsor Support Agreement, the Company may, under certain circumstances, accrue Regular Dividends and defer cash payment to the Sponsor until such circumstances are resolved.
Pursuant to the terms of the Conversion Agreement, the Sponsor and the Company agreed that, upon the Effective Date of the Conversion Agreement: (i) the Sponsor waived the Company’s obligation to pay the $3.7 million of dividends accrued on the Series A Preferred Stock as of the Effective Date; (ii) the Company waived the restriction and vesting requirement for the Contingent Sponsor Shares, making these shares unrestricted and freely tradable; (iii) the Company agreed to make a voluntary, temporary reduction in the conversion price, pursuant to the terms of the Certificate of Designation, of all of the outstanding shares of Series A Preferred Stock effective December 20, 2024 through January 20, 2025 from $11.50 per share of Common Stock issuable upon conversion of a share of Series A Preferred Stock to $3.63 per share (the “Conversion Price Reduction”), with the conversion ratio determined by dividing the $10.00 original issue price of the Series A Preferred Stock by such Conversion Price; and (iv) the Sponsor agreed to convert 373,333 shares of Series A Preferred Stock into 1,028,986 shares of Common Stock at the temporary Conversion Price.
As the Company was legally released from its obligation to pay certain accrued dividends to the Sponsor, the Company derecognized the accrued dividends in the amount of $3.7 million as a result of the Conversion Agreement. The Company determined that the release of the accrued dividends represents paid-in-kind consideration in the form of a stock dividend, as the Sponsor agreed to receive Common Stock at a reduced conversion price under the Conversion Agreement in exchange for waiving the Company’s obligation to pay the accrued dividends.
Additionally, the Company determined that the conversion of the Series A Preferred Stock into Common Stock was an induced conversion as the reduced conversion price was only offered for a limited time and included the issuance of all equity securities issuable pursuant to the conversion privileges included in the terms of the Series A Preferred Stock for each share of Series A Preferred Stock that was converted to Common Stock.
11. Stock Options
On April 17, 2023, the Company’s board of directors adopted a new equity incentive plan, and the plan was approved by the stockholders on September 27, 2023 (the “2023 Equity Incentive Plan”). An aggregate of 4,000,000 shares of Common Stock are reserved and may be issued under the 2023 Equity Incentive Plan, provided that until such time as certain milestones are achieved the aggregate number of shares of Common Stock that may be issued pursuant to the 2023 Equity Incentive Plan will be 2,500,000 shares. As of March 31, 2025, there were options to acquire 2,295,904 shares of Common Stock outstanding under the 2023 Equity Incentive Plan. The Company initially values options at fair value on the grant date. For awards with periodic vesting, the Company recognizes the related expense on a straight-line basis over the requisite service period for the entire award, which generally vest based on continued service over four years and expireten years from the date of grant, subject to periodic adjustments to ensure that the cumulative amount of expense recognized through the end of any reporting period is at least equal to the portion of the grant date value of the award that has vested through that date. Certain stock options granted in 2023 under the 2023 Equity Incentive Plan have a certain percentage that are exercisable at any time following the date of grant and then vest based on continuous service over three years and expireten years from the date of grant.
The Company uses the Black-Scholes option model to estimate the fair value of stock options. In applying the Black-Scholes option model, the Company used the following assumptions in the valuation of options granted during the three months ended March 31, 2025 and 2024:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Expected volatility | 76.0% | 50.0% |
| Expected dividend yield | — | — |
| Expected life (years) | 6.08 | 6.25 |
| Risk-free rate | 4.4% | 3.0% |
The following table summarizes the Company’s stock option activity for the three months ended March 31, 2025:
| Options | Weighted-average Exercise Price per Option | Weighted-average Remaining Contractual Term (Years) | Aggregate Intrinsic Value | |
|---|---|---|---|---|
| Outstanding at December 31, 2024 | 2,214,769 | $2.38 | 8.9 | $4,956 |
| Granted | 90,000 | $1.54 | 9.9 | $— |
| Terminated | (8,865) | $2.68 | N/A | $— |
| Outstanding at March 31, 2025 | 2,295,904 | $2.34 | 8.7 | $— |
| Exercisable and vested at March 31, 2025 | 1,300,997 | $2.39 | 8.6 | $— |
The stock-based compensation expense related to option grants was $0.2 million and $0.1 million for the three months ended March 31, 2025 and 2024, respectively.
The weighted average grant date fair value of option activity for the three months ended March 31, 2025 is as follows:
| Shares | Weighted- average Grant Date Fair Value | |
|---|---|---|
| Unvested balance at December 31, 2024 | 988,128 | $1.81 |
| Granted | 90,000 | $1.07 |
| Vested | (74,356) | $1.65 |
| Forfeited | (8,865) | $1.83 |
| Unvested balance at March 31, 2025 | 994,907 | $1.75 |
As of March 31, 2025, stock-based compensation related to unvested option awards of $1.7 million remains unamortized, which is expected to be recognized over a weighted-average period of 2.7 years.
Total stock-based compensation expense associated with stock options was classified as follows on the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024:
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Research and development expense | $63 | $27 |
| Sales and marketing expense | 4 | 3 |
| General and administrative expense | 93 | 93 |
| Total stock-based compensation expense | $160 | $123 |
Employee Stock Purchase Plan
In September 2023, the Company established an employee stock purchase plan under which eligible employees may direct the Company to withhold up to 15% of their gross pay to purchase shares of Common Stock at a price equal to 85% of the lower of the offering date stock price or exercise date stock price. During the three months ended March 31, 2025 and 2024, there wereno shares of Common Stock purchased under the employee stock purchase plan.
12. Segment Reporting
Operating segments are identified as components of an enterprise about which discrete financial information is available for evaluation by the CODM in deciding resource allocation and assessing performance. The Company has determined that its CODM is its Chief Executive Officer.
The Company hasone reportable segment: hearing. The hearing segment derives revenue from the sale of the Esteem FI-AMEI implants and replacement components to Esteem FI-AMEI implants. The Company enters into arrangements with patients to provide them with the Esteem FI-AMEI device, personal programmer devices, sound processor replacements, and Battery replacements.
The Company derives revenue primarily in the United States and manages the business activities on a consolidated basis.
The accounting policies of the hearing segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for the hearing segment and decides how to allocate resources based on net loss that also is reported on the condensed consolidated statements of operations and comprehensive loss. The measure of segment assets is reported on the condensed consolidated balance sheets as total assets.
The CODM uses net loss to evaluate the results generated from segment assets (return on assets) in deciding whether to make investments into the hearing segment or into other parts of the entity, such as for entering into significant contracts, hiring of key management or executive personnel, making significant capital investment decisions, or changing Company-wide strategy.
Net loss is used to monitor budget versus actual results and assist the CODM in understanding the Company’s cash flows and liquidity position, which is critical as a development state entity. This allows the CODM to make the appropriate spending decisions for the Company.
The following table summarizes the significant expense categories regularly reviewed by the CODM for the three months ended March 31, 2025 and 2024.
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Net revenues | $46 | $59 |
| Costs and operating expenses: | ||
| Cost of goods sold | 226 | 153 |
| Research and development | 2,748 | 2,360 |
| Sales and marketing | 358 | 325 |
| General and administrative | 1,821 | 2,105 |
| Total costs and operating expenses | 5,153 | 4,943 |
| Operating loss | (5,107) | (4,884) |
| Other segment items(1) | 615 | (1,336) |
| Interest expense, related party | (495) | (36) |
| Other expense, net | (11) | (14) |
| Total other income (expense), net | 109 | (1,386) |
| Net loss | $(4,998) | $(6,270) |
| (1) | Other segment items include the change in fair value of forward purchase agreement put option liability, change in fair value of forward purchase agreement warrant liability, and change in fair value of publicly traded warrant liability. |
13. Related Party Transactions
The Company had various transactions with a member of its board of directors and a controlling stockholder of the Company, which is considered a related party.
| ● | The Company leases its headquarters office space in Minnesota from a company owned by the stockholder. The lease is considered a common control leasing arrangement. The lease liability due to the stockholder was $0.9 million and $0.9 million as of March 31, 2025 and December 31, 2024, respectively. See Note 6 for additional information related to this lease including the operating lease cost for the three months ended March 31, 2025 and 2024. |
| ● | The Company received Term Loans from the stockholder during 2024 and 2025 (see Note 8). |
| ● | The Company has a shared services arrangement with a company that is indirectly owned by the stockholder, for certain support services used in the course of business. This arrangement originated on January 1, 2022 with a term of two years that automatically renews each year thereafter unless terminated by either party. In relation to the shared services arrangement, the Company expensed less than $0.1 million during both the three months ended March 31, 2025 and 2024. |
14. Commitment and Contingencies
The Company is party to various litigation matters arising from time to time in the ordinary course of business.
On November 14, 2023, the Company, Whitney Haring-Smith (the former chief executive officer and a former director of the Company), Daniel Hirsch (the former chief financial officer of the Company), and Anzu SPAC GP I LLC were named as defendants in a complaint filed by Atlas Merchant Capital SPAC Fund I LP (“Atlas”) in the Delaware Court of Chancery. Atlas alleges that it was not allowed to redeem its shares of the Company’s Common Stock and that the defendants acted to prevent Atlas’s attempt to redeem its shares. The defendants assert that Atlas did not comply with the requirements for redeeming shares set forth in the Company’s organizational documents. Atlas asserts damages in the amount of approximately $9.4 million, pre- and post-judgment interest, costs, and reasonable attorneys’ fees. The Company has standard indemnification obligations to Dr. Haring-Smith and Mr. Hirsch. The Company believes that the lawsuit is meritless and has been defending this matter vigorously. The Company is unable to predict the outcome of this legal proceeding.
The Company has business liability insurance to cover litigation costs exceeding $50 thousand. As of March 31, 2025 and December 31, 2024, the Company has not recorded accruals for potential losses related to any existing or pending litigation claims as the Company’s management determined that there are no matters where a potential loss is probable and reasonably estimable.
15. Net Loss per Share
The following table sets forth the computation of basic and diluted loss per share (in thousands, except share and per share amounts):
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Numerator: | ||
| Net loss | $(4,998) | $(6,270) |
| Less: Cumulative preferred dividends | (1,238) | (1,365) |
| Net loss attributable to common stockholders, basic and diluted | $(6,236) | $(7,635) |
| Denominator: | ||
| Weighted-average Common Stock outstanding, basic and diluted | 21,326,609 | 18,599,982 |
| Net loss per share attributable to common stockholders, basic and diluted | $(0.29) | $(0.41) |
The Company’s potentially dilutive securities below, presented based on amounts outstanding at each period end, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of shares of Common Stock outstanding used to calculate both basic and diluted net loss per share attributable to stockholders of Common Stock for these periods is the same.
| Three Months Ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock options | 2,295,904 | 1,999,689 |
| Series A Preferred Stock (as converted to common stock) | 3,588,406 | 3,913,043 |
| Publicly traded warrants | 14,166,666 | 14,166,666 |
| Shortfall Warrants | 3,209,511 | 3,874,394 |
| Contingent Sponsor Shares | — | 1,000,000 |
| Term Loan Warrants | 2,750,000 | 500,000 |
| 26,010,487 | 25,453,792 | |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.