季報
季度報告
10-Q
2026-08-10
Envoy Medical第二季虧損598萬美元 現金不足撐一年營運存重大疑問
AI 繁中摘要
Envoy Medical, Inc.（納斯達克：COCH / COCHW）公布截至2026年6月30日止第二季度10-Q業績。公司專注研發全植入式聽力解決方案，目前主力產品為研究階段的Acclaim®人工耳蝸植入體，已獲FDA突破性設備認定。
📊 第二季度（2026年4月至6月）業績重點：
- 淨收入：5.1萬美元，按年下跌約35%（去年同期7.8萬美元）
- 淨虧損：598.2萬美元（去年同期569萬美元），每股虧損0.07美元（以加權平均1.04億股計算）
- 研發開支：313.2萬美元，按年增加約26%
- 管理及行政開支：202.9萬美元，大致持平
- 銷售及市場推廣開支：18.1萬美元，按年大幅減少
上半年（截至2026年6月30日）累計：
- 淨收入：9萬美元（去年同期12.4萬美元）
- 淨虧損：1,033.3萬美元（去年同期1,068.8萬美元）
- 每股虧損：0.15美元
💰 財務狀況：
截至2026年6月30日，現金約1,967.9萬美元，較去年底373.9萬美元大幅增加，主要受惠於2月份發行普通股、預付資金認股權證及A系列認股權證，集資淨額約2,778.2萬美元。累計虧損3.26369億美元。
⚠️ 持續經營風險：
管理層明確認定，現有現金不足以支持未來至少一年的營運開支，存在重大疑問。公司計劃透過行使未行使認股權證或額外融資應對，但無法保證能成功取得資金。若未能籌集足夠資金，可能需削減酌情開支，影響臨床試驗進度及業務目標。
其他要點：
- 與關聯方貸款已於2025年8月獲寬免，相關利息開支不再出現
- 認股權證公平值變動帶來非現金盈虧，其中私人認股權證上半年錄得收益116.7萬美元
- 截至2026年6月30日，已發行普通股約7,719.5萬股
投資者需注意，公司仍處於研發階段，收入極低，且高度依賴外部融資維持營運。短期內股價或受集資消息及臨床試驗進展主導，風險偏高。
展開英文正文
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D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2026 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission File Number 001-40133 ENVOY MEDICAL, INC. (Exact name of registrant as specified in its charter) Delaware 86-1369123 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 4875 White Bear Parkway, White Bear Lake, MN 55110 (Address of principal executive offices) (877) 900-3277 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Class A Common Stock, par value $0.0001 per share COCH The Nasdaq Stock Market LLC Redeemable Warrants, each exercisable for one share of Class A Common Stock at an exercise price of $11.50 per share COCHW The Nasdaq Stock Market LLC Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large Accelerated Filer ☐ Accelerated Filer ☐ Non-accelerated Filer ☒ Smaller Reporting Company ☒ Emerging Growth Company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ As of August 10, 2026, the registrant had 77,194,595 shares of Class A Common Stock, par value $0.0001 per share, issued and outstanding. ENVOY MEDICAL, INC. Quarterly Report on Form 10-Q For the Quarterly Period ended June 30, 2026 Table of Contents Page PART I FINANCIAL INFORMATION ITEM 1. Financial Statements Condensed Consolidated Balance Sheets as of June 30, 2026 (Unaudited) and December 31, 2025 1 Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2026 and 2025 2 Unaudited Condensed Consolidated Statements of Changes in Mezzanine Equity and Stockholders’ Equity (Deficit) for the three and six months ended June 30, 2026 and 2025 3 Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2026 and 2025 4 Notes to Unaudited Condensed Consolidated Financial Statements 5 ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 21 ITEM 3. Quantitative and Qualitative Disclosures About Market Risk 34 ITEM 4. Controls and Procedures 34 PART II OTHER INFORMATION ITEM 1. Legal Proceedings 36 ITEM 1A. Risk Factors 36 ITEM 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities 36 ITEM 3. Defaults Upon Senior Securities 36 ITEM 4. Mine Safety Disclosures 36 ITEM 5. Other Information 36 ITEM 6. Exhibits 37 PART III SIGNATURES 38 i ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (In thousands, except share and per share amounts) June 30, December 31, 2026 2025 (unaudited) Current assets: Cash $ 19,679 $ 3,739 Accounts receivable, net 49 34 Other receivable 17 19 Inventories 1,579 1,546 Prepaid expenses and other current assets 593 941 Total current assets 21,917 6,279 Property and equipment, net 921 1,035 Operating lease right-of-use asset (related party) 818 886 Prepaid expenses and other assets 293 358 Total assets $ 23,949 $ 8,558 Liabilities, mezzanine equity, and stockholders’ equity (deficit) Current liabilities: Accounts payable $ 2,035 $ 2,920 Accrued expenses 10,032 7,639 Forward purchase agreement warrant liability 14 24 Product warranty liability, current portion 255 287 Operating lease liability, current portion (related party) 132 174 Other current liabilities 166 518 Total current liabilities 12,634 11,562 Product warranty liability, net of current portion 1,543 1,605 Operating lease liability, net of current portion (related party) 678 745 Private warrant liability 4,668 5,835 Publicly traded warrant liability 705 551 Other liability 27 27 Total liabilities 20,255 20,325 Commitments and contingencies (see Note 14) Mezzanine equity Warrants issued to placement agent as part of the 2025 Offerings (see Note 9) 391 391 Stockholders’ equity (deficit) Series A Preferred Stock, $0.0001 par value; 100,000,000 shares authorized and 10,000,000 shares designated as of June 30, 2026 and December 31, 2025; 4,126,667 shares issued and outstanding as of June 30, 2026 and December 31, 2025 - - Class A Common Stock, $0.0001 par value; 400,000,000 shares authorized as of June 30, 2026 and December 31, 2025; 77,194,595 shares issued and outstanding as of June 30, 2026 and 28,934,960 shares issued and outstanding as of December 31, 2025 8 3 Additional paid-in capital 329,786 301,355 Accumulated deficit (326,369 ) (313,396 ) Accumulated other comprehensive loss (122 ) (120 ) Total stockholders’ equity (deficit) 3,303 (12,158 ) Total liabilities, mezzanine equity, and stockholders’ equity (deficit) $ 23,949 $ 8,558 The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 1 ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) (In thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Net revenues $ 51 $ 78 $ 90 $ 124 Costs and operating expenses: Cost of goods sold 278 234 591 460 Research and development 3,132 2,485 6,774 5,233 Sales and marketing 181 361 345 719 General and administrative 2,029 2,068 3,908 3,889 Total costs and operating expenses 5,620 5,148 11,618 10,301 Operating loss (5,569 ) (5,070 ) (11,528 ) (10,177 ) Other income (expense): Change in fair value of forward purchase agreement warrant liability 23 37 10 458 Loss on offering and change in fair value of private warrant liability (838 ) - 1,167 - Change in fair value of publicly traded warrant liability 236 (32 ) (154 ) 162 Interest expense (related party) - (624 ) - (1,119 ) Other income (expense), net 166 (1 ) 172 (12 ) Total other income (expense), net (413 ) (620 ) 1,195 (511 ) Net loss (5,982 ) (5,690 ) (10,333 ) (10,688 ) Cumulative preferred dividends (1,290 ) (1,252 ) (2,640 ) (2,490 ) Net loss attributable to common stockholders, basic and diluted $ (7,272 ) $ (6,942 ) $ (12,973 ) $ (13,178 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.07 ) $ (0.32 ) $ (0.15 ) $ (0.62 ) Weighted-average Class A Common Stock and pre-funded warrants outstanding, basic and diluted 104,039,109 21,383,852 86,584,007 21,355,388 Other comprehensive (loss) income: Foreign currency translation adjustment (1 ) (2 ) (2 ) 4 Other comprehensive (loss) income (1 ) (2 ) (2 ) 4 Comprehensive loss $ (5,983 ) $ (5,692 ) $ (10,335 ) $ (10,684 ) The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 2 ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN MEZZANINE EQUITY AND STOCKHOLDERS’ EQUITY (DEFICIT) (UNAUDITED) (In thousands, except share amounts) For the Three and Six Months Ended June 30, 2026 Mezzanine Equity Permanent Equity Accumulated Total Series A Class A Additional Other Stockholders’ Number of Preferred Stock Common Stock Paid-in Accumulated Comprehensive Equity Warrants Amount Shares Amount Shares Amount Capital Deficit Loss (Deficit) Balance at December 31, 2025 368,694 $ 391 4,126,667 $ - 28,934,960 $ 3 $ 301,355 $ (313,396 ) $ (120 ) $ (12,158 ) Dividends on the Series A Preferred Stock - - - - - - - (1,350 ) - (1,350 ) Stock-based compensation - - - - - - 239 - - 239 Net proceeds from issuance of Class A Common Stock, Issued Pre-Funded Warrants, and Series A Warrants in February 2026 Offering - - - - 47,946,150 5 27,777 - - 27,782 Foreign currency translation adjustment - - - - - - - (1 ) (1 ) Net loss - - - - - - - (4,351 ) - (4,351 ) Balance at March 31, 2026 368,694 $ 391 4,126,667 $ - 76,881,110 $ 8 $ 329,371 $ (319,097 ) $ (121 ) $ 10,161 Dividends on the Series A Preferred Stock - - - - - - - (1,290 ) - (1,290 ) Stock-based compensation - - - - - - 214 - - 214 Issuance of Common Stock under employee stock purchase plan - - - - 173,485 - 104 - - 104 Issuance of Class A Common Stock for services - - - - 140,000 - 97 - - 97 Foreign currency translation adjustment - - - - - - - - (1 ) (1 ) Net loss - - - - - - - (5,982 ) - (5,982 ) Balance at June 30, 2026 368,694 $ 391 4,126,667 $ - 77,194,595 $ 8 $ 329,786 $ (326,369 ) $ (122 ) $ 3,303 For the Three and Six Months Ended June 30, 2025 Permanent Equity Accumulated Total Series A Class A Additional Other Stockholders’ Preferred Stock Common Stock Paid-in Accumulated Comprehensive Equity Shares Amount Shares Amount Capital Deficit Loss (Deficit) Balance at December 31, 2024 4,126,667 $ - 21,326,609 $ 2 $ 266,013 $ (284,734 ) $ (123 ) $ (18,842 ) Dividends on the Series A Preferred Stock - - - - - (1,238 ) - (1,238 ) Stock-based compensation - - - - 160 - - 160 Issuance of warrants associated with the Term Loans - - - - 688 - - 688 Foreign currency translation adjustment - - - - - - 6 6 Net loss - - - - - (4,998 ) - (4,998 ) Balance at March 31, 2025 4,126,667 $ - 21,326,609 $ 2 $ 266,861 $ (290,970 ) $ (117 ) $ (24,224 ) Dividends on the Series A Preferred Stock - - - - - (1,252 ) - (1,252 ) Stock-based compensation - - - - 146 - - 146 Issuance of warrants associated with Term Loans - - - - 882 - - 882 Issuance of Common Stock from at-the-market (“ATM”) offering - - 134,771 - 204 - - 204 Issuance of Common Stock under employee stock purchase plan - - 59,552 - 77 - - 77 Foreign currency translation adjustment - - - - - - (2 ) (2 ) Net loss - - - - - (5,690 ) - (5,690 ) Balance at June 30, 2025 4,126,667 $ - 21,520,932 $ 2 $ 268,170 $ (297,912 ) $ (119 ) $ (29,859 ) The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 3 ENVOY MEDICAL, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (Dollars in thousands) Six Months Ended June 30, 2026 2025 Cash flows from operating activities Net loss $ (10,333 ) $ (10,688 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 147 146 Interest expense and amortization of debt discount on Term Loans (related party) - 1,118 Stock-based compensation for services 76 - Amortization of prepaid insurance 463 493 Stock-based compensation 453 306 Loss on offering and change in fair value of private warrant liability (1,167 ) - Change in fair value of publicly traded warrant liability 154 (162 ) Change in fair value of forward purchase agreement warrant liability (10 ) (458 ) Net change in operating lease (related party) 111 51 Change in inventory reserve 26 10 Changes in operating assets and liabilities: Accounts receivable, net (15 ) (5 ) Other receivable 2 760 Inventories (59 ) 111 Prepaid expenses and other assets 40 (42 ) Accounts payable (912 ) (33 ) Operating lease liability (related party) (152 ) (44 ) Accrued expenses (247 ) 312 Product warranty liability (94 ) (60 ) Net cash used in operating activities (11,517 ) (8,185 ) Cash flows from investing activities Purchases of property and equipment (6 ) (7 ) Net cash used in investing activities (6 ) (7 ) Cash flows from financing activities Payments on insurance financing loans (421 ) (469 ) Proceeds from the issuance of Term Loans (related party) - 10,000 Dividends paid to stockholders of Series A Preferred Stock - (1,820 ) Proceeds from the issuance of Class A Common Stock from ATM offering - 204 Proceeds from issuance of Class A Common Stock under employee stock purchase plan 104 77 Proceeds from the issuance of Class A Common Stock, Issued Pre-Funded Warrants, and Series A Warrants 29,997 - Offering costs from the issuance of Class A Common Stock, Issued Pre-Funded Warrants, and Series A Warrants (2,215 ) - Net cash provided by financing activities 27,465 7,992 Effect of exchange rate changes on cash (2 ) 4 Net increase (decrease) in cash 15,940 (196 ) Cash, beginning of period 3,739 5,483 Cash, end of period $ 19,679 $ 5,287 Supplemental disclosures of cash flow information: Cash paid for interest $ 17 $ 20 Non-cash investing and financing activities: Accrued and unpaid dividends on Series A Preferred Stock $ 2,640 $ 670 Financing of prepaid insurance $ 69 $ 75 Issuance of Term Loan Warrants (related party) $ - $ 1,570 Accrued interest capitalized into term loans payable (related party) $ - $ 600 Property and equipment purchased on account $ 27 $ - Issuance of Placement Agent Warrants $ 678 $ - The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. 4 ENVOY MEDICAL, INC. NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Dollars in thousands, except share and per share data) 1. Nature of the Business and Basis of Presentation Envoy Medical, Inc. (“Envoy Medical” or the “Company”) is a hearing health company focused on the development of fully implanted hearing solutions. The Company has developed two fully implanted hearing devices built around the Company’s proprietary sensor technology, which is implanted in the middle ear. These fully implanted hearing devices are designed to leverage the ear’s natural anatomy to capture sound and eliminate the need for external or subdermal microphones. The Company’s first 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 received approval from the United States Food and Drug Administration (“FDA”) in 2010 and remains the only fully implanted hearing device to successfully receive FDA approval. The Company has shifted its focus to the Company’s second product, the investigational fully implanted Acclaim® Cochlear Implant (“Acclaim CI”), which the Company believes to be the first fully implantable cochlear implant. The Acclaim CI is designed with no external components worn on or behind the ear, does not use an external or subdermal microphone and incorporates an implanted rechargeable battery designed to last several days between charges. The Acclaim CI received the Breakthrough Device Designation from the FDA in 2019. The Acclaim CI is designed to address sensorineural hearing loss that is not adequately addressed by hearing aids. As part of the clinical trial, the Acclaim CI is intended for adults with severe-to-profound sensorineural hearing loss who have been deemed adequate candidates by a qualified physician. The unaudited 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. 2. Summary of Significant Accounting Policies Liquidity and Going Concern Since inception, the Company has historically incurred negative operating cash flows and losses from operations as the Company advances the clinical development of its products and the funding process of clinical FDA trials. These matters raise substantial doubt about the Company’s ability to continue as a going concern and although management has developed plans intended to support ongoing operations, such plans do not alleviate the substantial doubt. As of June 30, 2026, the Company has an accumulated deficit of $326,369. On various dates in 2025, the Company received net proceeds of $414 from an at-the-market (“ATM”) offering for 300,742 shares of Class A common stock, par value $0.0001 per share (“Class A Common Stock”) and $3,111 from the exercise by the Meteora Parties of Shortfall Warrants for 2,074,012 shares of Class A Common Stock (see Note 9). On September 23, 2025, the Company completed the September 2025 Offering, as defined in Note 9, and received net proceeds of $2,187 for 1,908,402 shares of Class A Common Stock. On October 9, 2025, the Company completed the October 2025 Offering, as defined in Note 9, and received net proceeds of $3,545 for 3,007,524 shares of Class A Common Stock. On February 12, 2026, the Company completed the February 2026 Offering, as defined in Note 9, and received net proceeds of $27,782 for an aggregate of (i) 47,946,150 shares of Class A Common Stock and (ii) 27,053,850 pre-funded warrants to purchase 27,053,850 shares of Class A Common Stock. The existing cash of $19,679 as of June 30, 2026 will not be sufficient to fund operations through at least one year from the date the unaudited condensed consolidated financial statements are issued. Management’s plans to alleviate the conditions that raise substantial doubt include potential proceeds from the exercise of outstanding warrants (see Note 9) or other financing sources. Existing cash balances along with any potential proceeds will be used to continue funding operations, including the