A downtrend has been apparent in Envoy Medical, Inc. (COCH) lately. While the stock has lost 5.2% over the past week, it could witness a trend reversal as a hammer chart pattern was formed in its last trading session. This could mean that the bulls have been able to counteract the bears to help the stock find support.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts about the future ...

Market Overview - U.S. stocks experienced an upward trend, with the Nasdaq Composite increasing by over 150 points on Wednesday. The Dow rose by 0.08% to 46,642.55, the NASDAQ increased by 0.70% to 22,947.47, and the S&P 500 gained 0.35% to 6,738.32 [1] - Information technology shares saw a notable increase of 1.1% on Tuesday, while energy stocks declined by 0.9% [1] Mortgage Applications - The volume of mortgage applications in the U.S. decreased by 4.7% for the week ending October 3, following a more significant drop of 12.7% in the previous week [2][7] Commodity Prices - In commodity markets, oil prices rose by 0.9% to $62.26, gold increased by 1.3% to $4,058.00, silver was up by 1.9% to $48.395, and copper saw a slight rise of 0.1% to $5.0985 [4] European Markets - European shares showed positive performance, with the eurozone's STOXX 600 rising by 0.7%, Spain's IBEX 35 Index increasing by 0.8%, London's FTSE 100 up by 0.6%, Germany's DAX 40 gaining 0.8%, and France's CAC 40 rising by 0.9% [5] Asian Markets - Asian markets closed lower, with Japan's Nikkei 225 falling by 0.45%, Hong Kong's Hang Seng index down by 0.48%, and India's BSE Sensex declining by 0.19% [6] Stock Movements - Xenetic Biosciences, Inc. (NASDAQ: XBIO) shares surged by 174% to $11.75, while Connexa Sports Technologies Inc. (NASDAQ: YYAI) saw a 102% increase to $0.3639. AlphaTON Capital Corp. (NASDAQ: ATON) shares rose by 81% to $10.08 [8] - Conversely, Galecto, Inc. (NASDAQ: GLTO) shares dropped by 42% to $10.48 after a significant jump of 383% on Tuesday. Zeta Network Group (NASDAQ: ZNB) shares fell by 41% to $2.00 following a $15 million registered direct offering at $1.00 per share. Envoy Medical, Inc. (NASDAQ: COCH) also experienced a decline of 38% to $0.9854 after announcing a $4 million registered direct offering at $1.33 per share [8]

Biotech and Medical Tech Stocks to Watch - Big Moves Following Clinical Trial News October 8, 2025 - (Investorideas.com Newswire), a go-to investing platform covering biotech and medtech stocks releases an industry snapshot looking at recent clinical trial updates, featuring Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases. Recent clinical trial update news from Aethlon Medical, Inc. (Nasdaq: AE ...

Core Insights - Several companies have experienced significant stock price declines, impacting investor sentiment and market performance [1] Company Summaries Chijet Motor Company, Inc. (NASDAQ:CJET) - Stock price dropped to $0.19, reflecting a -33.69% change, with a yearly range of $0.078 to $2.99 [2] - The company focuses on innovation in the electric vehicle sector and has appointed Jason Miller as COO to lead its transition into digital currency [2] - Strategic integration of major cryptocurrencies like Bitcoin, Ethereum, and Solana into its balance sheet is planned [2] AtlasClear Holdings, Inc. (NYSE American:ATCH) - Experienced a -33.13% change, with stock price falling to $0.61, ranging from $0.137 to $26.94 over the year [3] - The company is navigating challenging market conditions under CEO Ilya Bogdanov, emphasizing its trading and settlement platform [3] - Recently closed a $3 million financing round with the potential to raise an additional $2 million [3] Envoy Medical, Inc. (NASDAQ:COCH) - Stock price fell to $0.90, marking a -30.55% change, with a price range of $0.88 to $3.99 [4] - The company offers innovative medical technologies for hearing loss and is led by CEO Brent T. Lucas [4] - Announced a $2.5 million registered direct offering and a concurrent private placement for additional shares [4] Market Outlook - Despite significant price declines, these companies continue to pursue innovation and growth, with leadership committed to navigating market challenges [5]

Core Insights - Envoy Medical has made significant progress in the third quarter of 2025, focusing on redefining hearing health with fully implanted devices as the standard of care [2][3] Financial Developments - The company eliminated over $32 million in debt, simplifying its capital structure and enhancing shareholder equity [4][3] - This debt elimination allows for a greater focus on strategic growth initiatives to drive shareholder value [5] Patent and Intellectual Property Expansion - Envoy Medical has expanded its global patent portfolio, now holding approximately 38 granted US patents and 40 foreign patents, with seven new patents secured recently [6][3] - The company has solidified its ownership of the "Invisible Hearing" trademark in Australia, complementing existing registrations in the US, UK, and Europe [8][6] Clinical Trial Progress - The pivotal clinical trial for the Acclaim® cochlear implant is progressing as planned, with all 10 patients in the first stage reaching their three-month follow-up visits without serious adverse events [13][3] - The company aims to submit its Premarket Approval (PMA) application to the FDA in 2027 [13] Reimbursement Strategy - New Category III CPT codes for totally-implantable active middle ear implants, including the Esteem® device, took effect on July 1, 2025, enhancing reimbursement potential [16][3] - Positive changes in reimbursement for the Esteem® device could drive broader adoption and create substantial business opportunities for Envoy Medical [17][16] Public Health Impact - Untreated hearing loss is linked to increased dementia risk, emphasizing the importance of timely intervention and the role of Envoy Medical's solutions in supporting long-term brain health [18][19] - The company's fully implanted solutions aim to provide reliable hearing without external devices, addressing both hearing restoration and public health concerns [19] Future Outlook - Envoy Medical is entering the final quarter of 2025 with a strengthened balance sheet, an expanded intellectual property portfolio, and clinical trial momentum, indicating a bright future [20][3] - The company remains committed to redefining hearing health and delivering long-term value to shareholders [21]

Core Insights - Envoy Medical has secured three new patents in the U.S., Australia, and Hong Kong, enhancing its leadership in fully implantable hearing technology [2][3][6] - The patents are aimed at advancing next-generation cochlear implant solutions, providing patients with a discreet and continuous hearing experience [2][3] Patent Details - U.S. Patent No. 12,390,634 relates to a fully implantable modular cochlear implant system that includes a signal processor and an implantable battery or communication module [3] - Australian Patent No. 2022254630 focuses on electrode impedance diagnostics in cochlear implant systems, determining stimulation parameters based on impedance [3] - Hong Kong Patent No. 40101898 pertains to cochlear implant stimulation calibration, adjusting current flow based on testing circuit outputs [3] Company Vision and Strategy - The CEO of Envoy Medical, Brent Lucas, emphasized that the new patents are critical for redefining hearing restoration solutions and expanding the company's global patent portfolio [3][6] - The company aims to eliminate daily limitations faced by millions with hearing loss through innovative, fully implantable solutions [3][6] Product Overview - Envoy Medical's Acclaim Cochlear Implant is designed for severe to profound sensorineural hearing loss and is the first fully implanted cochlear implant [8] - The Esteem fully implanted active middle ear implant is the only FDA-approved device of its kind, providing 24/7 hearing capability without external components [9]

分组1 - Envoy Medical, Inc. reported a quarterly loss of $0.32 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.29, and compared to a loss of $0.27 per share a year ago, indicating an earnings surprise of -10.34% [1] - The company posted revenues of $0.08 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 39.29%, and this represents an increase from year-ago revenues of $0.07 million [2] - Envoy Medical's shares have increased by approximately 8.9% since the beginning of the year, outperforming the S&P 500's gain of 8.2% [3] 分组2 - The earnings outlook for Envoy Medical is uncertain, with current consensus EPS estimates for the coming quarter at -$0.31 on $0.06 million in revenues, and -$1.18 on $0.2 million in revenues for the current fiscal year [7] - The Zacks Industry Rank indicates that the Medical - Instruments sector is currently in the bottom 40% of over 250 Zacks industries, suggesting that the industry outlook may negatively impact stock performance [8]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I) This section presents the unaudited condensed consolidated financial information, including statements and notes [ITEM 1. Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Envoy Medical, Inc., including the balance sheets, statements of operations and comprehensive loss, statements of changes in stockholders' deficit, and statements of cash flows, along with detailed notes explaining the company's business, significant accounting policies, fair value measurements, debt, equity, and other financial details for the periods ended June 30, 2025, and December 31, 2024 [Unaudited Condensed Consolidated Balance Sheets](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity | Assets/Liabilities/Equity (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------- | :------------ | :---------------- | | Cash | $5,287 | $5,483 | | Total current assets | $7,513 | $8,896 | | Total assets | $9,900 | $11,538 | | Total current liabilities | $8,000 | $7,538 | | Term loans payable (related party) | $27,932 | $18,716 | | Total liabilities | $39,759 | $30,380 | | Total stockholders' deficit | $(29,859) | $(18,842) | [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This statement details the company's revenues, expenses, and net loss over specific reporting periods | (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net revenues | $78 | $68 | $124 | $127 | | Total costs and operating expenses | $5,148 | $4,920 | $10,301 | $9,862 | | Operating loss | $(5,070) | $(4,852) | $(10,177) | $(9,735) | | Total other income (expense), net | $(620) | $905 | $(511) | $(482) | | Net loss | $(5,690) | $(3,947) | $(10,688) | $(10,217) | | Net loss per share (basic and diluted) | $(0.32) | $(0.29) | $(0.62) | $(0.70) | [Unaudited Condensed Consolidated Statements of Changes in Stockholders' Deficit](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Deficit) This statement outlines changes in the company's equity or deficit, including net loss and preferred stock dividends | (in thousands) | Balance at Dec 31, 2024 | Dividends on Series A Preferred Stock | Stock-based Compensation | Issuance of Warrants | ATM Offering Proceeds | Employee Stock Purchase Plan Proceeds | Net Loss | Balance at Jun 30, 2025 | | :------------- | :---------------------- | :------------------------------------ | :----------------------- | :------------------- | :-------------------- | :------------------------------------ | :------- | :---------------------- | | Total Stockholders' Deficit | $(18,842) | $(2,490) | $306 | $1,570 | $204 | $77 | $(10,688) | $(29,859) | - The company's total stockholders' deficit increased from **$(18,842) thousand** at December 31, 2024, to **$(29,859) thousand** at June 30, 2025, primarily due to net losses and preferred stock dividends, partially offset by warrant issuances and equity offerings[13](index=13&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes cash flows from operating, investing, and financing activities | Cash Flows (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(8,185) | $(10,235) | | Net cash used in investing activities | $(7) | $(899) | | Net cash provided by financing activities | $7,992 | $8,664 | | Net decrease in cash | $(196) | $(2,472) | | Cash, end of period | $5,287 | $1,746 | - Net cash used in operating activities decreased by **$2,050 thousand** (from $(10,235) thousand in 2024 to $(8,185) thousand in 2025) for the six months ended June 30, primarily due to a decrease in net loss and favorable changes in operating assets and liabilities[16](index=16&type=chunk) - Net cash provided by financing activities decreased by **$672 thousand** (from $8,664 thousand in 2024 to $7,992 thousand in 2025) for the six months ended June 30, despite higher proceeds from term loans in 2025, due to dividends paid to preferred stockholders[16](index=16&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations and additional information supporting the financial statements [1. Nature of the Business and Basis of Presentation](index=8&type=section&id=1.%20Nature%20of%20the%20Business%20and%20Basis%20of%20Presentation) This note describes the company's core business, key products, and financial statement preparation principles - Envoy Medical, Inc. is a hearing health company focused on innovative medical technologies, including its first commercial product, the Esteem® Fully Implanted Active Middle Ear Implant (Esteem FI-AMEI), approved by the FDA in 2010[17](index=17&type=chunk) - The company is developing the fully implanted Acclaim® Cochlear Implant (Acclaim CI), which received Breakthrough Device Designation from the FDA in 2019 and leverages a sensor instead of a microphone to capture sound[18](index=18&type=chunk) - Envoy Medical completed a merger transaction with Anzu Special Acquisition Corp I on September 29, 2023, and its Class A common stock and public warrants began trading on Nasdaq under 'COCH' and 'COCHW' respectively[19](index=19&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines critical accounting principles, including the going concern assessment - The company has incurred cumulative losses of **$297.9 million** as of June 30, 2025, raising substantial doubt about its ability to continue as a going concern, despite recent capital raises and management's belief in sufficient funding for the next year[25](index=25&type=chunk)[26](index=26&type=chunk) - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim reporting, reflecting all necessary adjustments for fair statement, and should be read with the annual Form 10-K[27](index=27&type=chunk) - Revisions were made to prior period financial statements for contingent sponsor shares, classification of prepaid insurance, accrued interest (related party), and financing of prepaid insurance, which were deemed immaterial to prior annual or interim periods[30](index=30&type=chunk)[32](index=32&type=chunk)[33](index=33&type=chunk)[35](index=35&type=chunk) [3. Fair Value Measurements](index=13&type=section&id=3.%20Fair%20Value%20Measurements) This note details valuation methodologies and inputs for assets and liabilities measured at fair value | Liabilities (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------- | :------------ | :---------------- | | Forward purchase agreement warrant liability | $14 | $472 | | Publicly traded warrant liability | $500 | $662 | | Total | $514 | $1,134 | - The fair value of the forward purchase agreement warrant liability (Level 3) decreased from **$472 thousand** to **$14 thousand**, primarily due to a decrease in stock price and was estimated using Monte Carlo simulation models[38](index=38&type=chunk)[39](index=39&type=chunk) - The publicly traded warrant liability (Level 1) decreased from **$662 thousand** to **$500 thousand**, valued using its listed price in an active market[38](index=38&type=chunk) [4. Inventories](index=14&type=section&id=4.%20Inventories) This note provides a breakdown of inventory components and their carrying values | Inventories (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------- | :------------ | :---------------- | | Raw materials | $1,406 | $1,386 | | Work-in-progress | $61 | $203 | | Finished goods | $120 | $119 | | Total | $1,587 | $1,708 | - Total inventories decreased from **$1,708 thousand** at December 31, 2024, to **$1,587 thousand** at June 30, 2025, primarily driven by a reduction in work-in-progress[40](index=40&type=chunk) [5. Property and Equipment, Net](index=14&type=section&id=5.%20Property%20and%20Equipment,%20Net) This note details property and equipment, including depreciation, and their net carrying values | Property and Equipment (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Lab equipment | $3,106 | $3,106 | | Production equipment | $2,250 | $2,249 | | Computer equipment | $654 | $648 | | Office equipment | $102 | $102 | | Total | $6,112 | $6,105 | | Less: Accumulated depreciation | $(4,976) | $(4,830) | | Property and equipment, net | $1,136 | $1,275 | - Net property and equipment decreased from **$1,275 thousand** at December 31, 2024, to **$1,136 thousand** at June 30, 2025, primarily due to accumulated depreciation of **$146 thousand** for the six months ended June 30, 2025[41](index=41&type=chunk) [6. Accrued Expenses](index=14&type=section&id=6.%20Accrued%20Expenses) This note provides a breakdown of various accrued liabilities, including excise tax, dividends, and payroll | Accrued Expenses (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------ | :------------ | :---------------- | | Accrued excise tax | $2,088 | $2,248 | | Dividends payable | $1,361 | $691 | | Accrued payroll | $526 | $204 | | Accrued other | $721 | $570 | | Total accrued expenses | $4,696 | $3,713 | - Total accrued expenses increased by **$983 thousand** from $3,713 thousand at December 31, 2024, to **$4,696 thousand** at June 30, 2025, mainly driven by an increase in dividends payable and accrued payroll[42](index=42&type=chunk) [7. Product Warranty Liability](index=14&type=section&id=7.%20Product%20Warranty%20Liability) This note details the estimated liability for product warranties, including key assumptions and changes | Product Warranty Liability (in thousands) | Amount | | :---------------------------------------- | :----- | | Balance as of December 31, 2024 | $2,053 | | Utilization | $(60) | | Balance at June 30, 2025 | $1,993 | - The product warranty liability decreased from **$2,053 thousand** at December 31, 2024, to **$1,993 thousand** at June 30, 2025, due to **$60 thousand** in utilization[43](index=43&type=chunk) - Key assumptions for the warranty liability include an estimated cost per unit of **$6 thousand**, a five-year average battery life, **3.9% inflationary increase**, and a **5.4% discount rate**, based on PRI-2012 mortality tables[43](index=43&type=chunk) [8. Debt (Related Party)](index=15&type=section&id=8.%20Debt%20(Related%20Party)) This note describes term loan agreements with a related party, including principal and interest - Envoy Medical has secured multiple term loans from GAT Funding, LLC, a related party, totaling **$30.0 million** in principal advances across February 2024, August 2024, and March 2025 Term Loans, each with an **8.0% annual interest rate** and five-year terms[44](index=44&type=chunk)[46](index=46&type=chunk)[51](index=51&type=chunk) - As of June 30, 2025, the outstanding balance on the February 2024 Term Loan was **$10.2 million**, August 2024 Term Loan was **$9.3 million**, and March 2025 Term Loan was **$8.4 million**, all net of discount[44](index=44&type=chunk)[46](index=46&type=chunk)[51](index=51&type=chunk) - The company issued warrants to purchase Common Stock as commitment fees for these term loans, with **1,500,000 warrants** issued during the six months ended June 30, 2025, and **500,000** during the same period in 2024[48](index=48&type=chunk)[49](index=49&type=chunk)[50](index=50&type=chunk)[53](index=53&type=chunk)[65](index=65&type=chunk) [9. Common Stock](index=17&type=section&id=9.%20Common%20Stock) This note provides details on common stock, including authorized and outstanding shares and warrant activity - As of June 30, 2025, Envoy Medical had **21,520,932 shares** of Class A Common Stock issued and outstanding, with **400,000,000 shares** authorized[5](index=5&type=chunk)[61](index=61&type=chunk) | Outstanding Warrants (shares) | December 31, 2024 | Issued (6 months ended June 30, 2025) | June 30, 2025 | | :---------------------------- | :---------------- | :------------------------------------ | :------------ | | Shortfall Warrants | 3,209,511 | — | 3,209,511 | | Publicly Traded Warrants | 14,166,666 | — | 14,166,666 | | Term Loan Warrants | 2,000,000 | 1,500,000 | 3,500,000 | - The company conducted an At-The-Market (ATM) equity offering program, selling **134,771 shares** of Common Stock for gross proceeds of **$212 thousand** (net **$204 thousand**) during the three and six months ended June 30, 2025[69](index=69&type=chunk) [10. Series A Preferred Stock](index=19&type=section&id=10.%20Series%20A%20Preferred%20Stock) This note details Series A Preferred Stock terms, including dividend rights, conversion features, and transactions - Envoy Medical has **4,126,667 shares** of Series A Preferred Stock outstanding, with holders entitled to a cumulative **12% Regular Dividend** per annum, payable quarterly in cash[71](index=71&type=chunk)[75](index=75&type=chunk) - Dividends on **2,500,000 Series A Preferred Stock shares** held by the Sponsor are deferred when the company has less than **$10.0 million** in net tangible assets; **$1.4 million** in unpaid dividends were accrued as of June 30, 2025, under this condition[78](index=78&type=chunk) - On December 20, 2024, the Sponsor waived **$3.7 million** in accrued dividends, and **373,333 Series A Preferred Stock shares** were converted into **1,028,986 Common Stock shares** at a temporarily reduced conversion price of **$3.63 per share**[83](index=83&type=chunk)[84](index=84&type=chunk) [11. Segment Reporting](index=21&type=section&id=11.%20Segment%20Reporting) This note explains the company's single reportable segment and how performance is assessed - Envoy Medical operates as a single reportable segment: hearing, deriving revenue from the sale of Esteem FI-AMEI implants and replacement components[87](index=87&type=chunk) - The Chief Operating Decision Maker (CEO) assesses performance and allocates resources based on net loss, which is reported on a consolidated basis[89](index=89&type=chunk)[90](index=90&type=chunk) | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net revenues | $78 | $68 | $124 | $127 | | Operating loss | $(5,070) | $(4,852) | $(10,177) | $(9,735) | | Net loss | $(5,690) | $(3,947) | $(10,688) | $(10,217) | [12. Related Party Transactions](index=22&type=section&id=12.%20Related%20Party%20Transactions) This note describes transactions with related parties, including debt, leases, and shared services - Envoy Medical engages in various transactions with a related party, GAT Funding, LLC (controlled by Glen A. Taylor, a board member and controlling stockholder)[95](index=95&type=chunk) - Related party transactions include leasing headquarters office space (lease liability of **$0.9 million** as of June 30, 2025), receiving Term Loans (see Note 8), and a shared services arrangement for support services[95](index=95&type=chunk) [13. Commitment and Contingencies](index=23&type=section&id=13.%20Commitment%20and%20Contingencies) This note discloses significant commitments and potential liabilities, including ongoing litigation - Envoy Medical is a defendant in a lawsuit filed by Atlas Merchant Capital SPAC Fund I LP, alleging improper redemption denial and seeking approximately **$9.4 million** in damages[97](index=97&type=chunk) - The company believes the lawsuit is meritless and is vigorously defending it, and as of June 30, 2025, has not recorded accruals for potential losses, determining no loss is probable and reasonably estimable[97](index=97&type=chunk)[98](index=98&type=chunk) [14. Net Loss per Share](index=23&type=section&id=14.%20Net%20Loss%20per%20Share) This note presents the calculation of basic and diluted net loss per share | (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss attributable to common stockholders | $(6,942) | $(5,312) | $(13,178) | $(12,947) | | Weighted-average Common Stock outstanding | 21,383,852 | 18,599,982 | 21,355,388 | 18,599,982 | | Net loss per share | $(0.32) | $(0.29) | $(0.62) | $(0.70) | - Potentially dilutive securities, including stock options, Series A Preferred Stock, and various warrants, were excluded from diluted net loss per share computation as their effect would be anti-dilutive[100](index=100&type=chunk) [15. Subsequent Events](index=23&type=section&id=15.%20Subsequent%20Events) This note discloses significant events occurring after the balance sheet date - On July 28, 2025, the company and Meteora parties amended the Shortfall Warrants (Amendment No. 3) to change the Exercise Price Floor to **$1.50** for the **3,209,511 outstanding warrants**[103](index=103&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Envoy Medical's financial condition and operational results, highlighting the company's focus on developing the Acclaim CI, the challenges with its existing Esteem FI-AMEI product, and the financial performance for the three and six months ended June 30, 2025 and 2024. It also discusses liquidity, capital resources, and critical accounting policies [Overview](index=26&type=section&id=Overview) This section summarizes the company's business, key products, and strategic development initiatives - Envoy Medical is a hearing health company focused on fully implanted hearing devices, with its lead product candidate being the Acclaim® Cochlear Implant (Acclaim CI), which received FDA Breakthrough Device Designation in 2019[110](index=110&type=chunk)[111](index=111&type=chunk) - The company's first product, the Esteem® Fully Implanted Active Middle Ear Implant (Esteem FI-AMEI), received FDA approval in 2010 but faced commercial challenges due to lack of reimbursement, leading the company to shift focus to the Acclaim CI in late 2015[112](index=112&type=chunk)[115](index=115&type=chunk) - The pivotal clinical study for Acclaim CI received IDE approval in October 2024, with the first **10 patients** implanted by mid-April 2025 and activated. The company targets expansion into the second stage in Q4 2025 or Q1 2026, with FDA PMA decision anticipated in H2 2027 or H1 2028[116](index=116&type=chunk)[117](index=117&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) [Macroeconomic Conditions](index=28&type=section&id=Macroeconomic%20Conditions) This section discusses the impact of global economic factors on the company's business and capital raising - Global macroeconomic challenges, including geopolitical conflicts, supply chain constraints, inflation, and interest rate volatility, have impacted Envoy Medical's business, financial performance, and ability to raise capital[125](index=125&type=chunk) - A potential recession or market correction could adversely affect sales of Esteem FI-AMEI implants and replacement components due to reduced disposable income and patient reluctance to seek treatment[127](index=127&type=chunk) [Key Components of Our Results of Operations](index=29&type=section&id=Key%20Components%20of%20Our%20Results%20of%20Operations) This section explains the primary drivers of revenue and expenses, including R&D and commercialization plans - Revenue is primarily derived from Esteem FI-AMEI implants and replacement components, recognized upon transfer of control. New implantations are expected to be minimal, but Acclaim CI commercialization is targeted for H2 2027 or H1 2028[129](index=129&type=chunk)[130](index=130&type=chunk) - Research and Development (R&D) expenses, primarily for Acclaim CI development, are expected to increase significantly as clinical trials progress and the product prepares for commercialization[133](index=133&type=chunk)[137](index=137&type=chunk) - Sales and marketing, and general and administrative expenses are also projected to increase due to growth, public company compliance costs, and expansion of operations[138](index=138&type=chunk)[141](index=141&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) This section analyzes financial performance for the reported periods, comparing current and prior year results **Three Months Ended June 30, 2025 vs. 2024 (in thousands):** | Item | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------------------------- | :------ | :------ | :--------- | :--------- | | Net revenues | $78 | $68 | $10 | 14.7% | | Cost of goods sold | $234 | $245 | $(11) | (4.5)% | | Research and development | $2,485 | $2,591 | $(106) | (4.1)% | | Sales and marketing | $361 | $497 | $(136) | (27.4)% | | General and administrative | $2,068 | $1,587 | $481 | 30.3% | | Operating loss | $(5,070) | $(4,852) | $(218) | 4.5% | | Change in fair value of forward purchase agreement warrant liability | $37 | $244 | $(207) | (84.8)% | | Change in fair value of publicly traded warrant liability | $(32) | $801 | $(833) | (104.0)% | | Interest expense, related party | $(624) | $(132) | $(492) | 372.7% | | Net loss | $(5,690) | $(3,947) | $(1,525) | 38.6% | **Six Months Ended June 30, 2025 vs. 2024 (in thousands):** | Item | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------------------------- | :------- | :------- | :--------- | :--------- | | Net revenues | $124 | $127 | $(3) | (2.4)% | | Cost of goods sold | $460 | $398 | $62 | 15.6% | | Research and development | $5,233 | $4,951 | $282 | 5.7% | | Sales and marketing | $719 | $822 | $(103) | (12.5)% | | General and administrative | $3,889 | $3,691 | $198 | 5.4% | | Operating loss | $(10,177) | $(9,735) | $(442) | 4.5% | | Change in fair value of forward purchase agreement put option liability | $0 | $103 | $(103) | (100.0)% | | Change in fair value of forward purchase agreement warrant liability | $458 | $(18) | $476 | (2644.4)% | | Change in fair value of publicly traded warrant liability | $162 | $(376) | $538 | (143.1)% | | Interest expense, related party | $(1,119) | $(168) | $(951) | 566.1% | | Net loss | $(10,688) | $(10,217) | $(471) | 4.56% | - Net loss increased by **$1,525 thousand** (**38.6%**) for the three months ended June 30, 2025, compared to the prior year, primarily due to a significant increase in interest expense from related party term loans and a decrease in fair value gains from warrant liabilities[147](index=147&type=chunk) - For the six months ended June 30, 2025, net loss increased by **$471 thousand** (**4.56%**), driven by higher R&D expenses, increased general and administrative costs (including a CFO severance accrual), and a substantial rise in related party interest expense[157](index=157&type=chunk)[160](index=160&type=chunk)[162](index=162&type=chunk)[166](index=166&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet obligations and its need for additional capital - Envoy Medical had **$5.3 million** in cash as of June 30, 2025, and expects existing funds, along with anticipated proceeds from the Forward Purchase Agreement or ATM, to fund operations beyond September 2025[168](index=168&type=chunk)[170](index=170&type=chunk) - The company has incurred significant operating losses and expects to continue doing so, necessitating additional capital raises through equity, debt, or strategic arrangements, which may not be available on favorable terms[168](index=168&type=chunk)[170](index=170&type=chunk) - The company's ability to continue as a going concern is subject to substantial doubt, contingent on successful future financing and meeting strategic plans[170](index=170&type=chunk) [Cash Flows](index=36&type=section&id=Cash%20Flows) This section analyzes cash sources and uses from operating, investing, and financing activities | Cash Flows (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------ | :----------------------------- | :----------------------------- | | Operating activities | $(8,185) | $(10,235) | | Investing activities | $(7) | $(899) | | Financing activities | $7,992 | $8,664 | | Net decrease in cash | $(196) | $(2,472) | - Net cash used in operating activities decreased by **$2.05 million** for the six months ended June 30, 2025, compared to 2024, primarily due to a lower net loss and **$1.0 million** in cash inflows from changes in operating assets and liabilities, including an income tax refund[172](index=172&type=chunk)[173](index=173&type=chunk) - Net cash provided by financing activities was **$8.0 million** for the six months ended June 30, 2025, mainly from **$10.0 million** in Term Loan proceeds and **$0.2 million** from ATM offerings, partially offset by **$1.8 million** in preferred stock dividends[177](index=177&type=chunk) [Contractual Obligations and Commitments](index=37&type=section&id=Contractual%20Obligations%20and%20Commitments) This section outlines significant contractual obligations and commitments, including debt and leases - Principal commitments include operating leases for office space, a litigation matter (Atlas lawsuit), and Term Loans with GAT Funding, LLC totaling **$30.0 million** in outstanding principal as of June 30, 2025[179](index=179&type=chunk) [Off-Balance Sheet Arrangements](index=37&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of any material off-balance sheet arrangements - Envoy Medical did not have any off-balance sheet arrangements during the periods presented[180](index=180&type=chunk) [Related Party Arrangements](index=37&type=section&id=Related%20Party%20Arrangements) This section details transactions and agreements with related parties, including financing and services - Related party arrangements include term loan financings, leasing headquarters office space, and contracting for IT services from a controlling stockholder[181](index=181&type=chunk) [Critical Accounting Policies and Estimates](index=38&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section describes accounting policies requiring significant judgment and estimation - Critical accounting policies involve significant estimates for fair value measurements (especially Level 3 instruments like forward purchase agreement warrant liability using Monte Carlo simulation), research and development expenses, product warranty liability, and stock-based compensation[182](index=182&type=chunk)[183](index=183&type=chunk)[184](index=184&type=chunk)[186](index=186&type=chunk)[189](index=189&type=chunk)[190](index=190&type=chunk) - As an emerging growth company, Envoy Medical has elected not to opt out of the extended transition period for complying with new or revised financial accounting standards[192](index=192&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section outlines Envoy Medical's exposure to various market risks, including currency, credit and counterparty, and inflation risks, and how these are managed and monitored [Currency Risk](index=40&type=section&id=Currency%20Risk) This section discusses exposure to foreign currency exchange rate fluctuations, primarily Euro-denominated - Envoy Medical operates primarily in the United States and Germany, with most transactions in USD, but certain bank balances and payables are denominated in Euro, exposing the company to foreign currency risk[194](index=194&type=chunk) - Foreign currency transactions are not expected to have a material effect on the company's results of operations, financial position, or cash flows[194](index=194&type=chunk) [Credit and Counterparty Risk](index=40&type=section&id=Credit%20and%20Counterparty%20Risk) This section addresses exposure to potential losses from counterparty failure to meet obligations - The company's credit risk primarily stems from cash and accounts receivable, with deposits held in high-credit-quality financial institutions and no material losses on accounts receivable[195](index=195&type=chunk)[196](index=196&type=chunk) [Inflation Risk](index=40&type=section&id=Inflation%20Risk) This section examines the potential impact of inflation on operating costs, gross margins, and financial performance - Inflationary factors could adversely affect operating results by increasing cost of goods sold and operating expenses, potentially impacting gross margin if product selling prices do not keep pace[197](index=197&type=chunk) - While inflation has not had a material impact to date, a high rate in the future could negatively affect the company's financial performance[197](index=197&type=chunk) [ITEM 4. Controls and Procedures](index=40&type=section&id=ITEM%204.%20Controls%20and%20Procedures) This section details the evaluation of Envoy Medical's disclosure controls and procedures, identifies material weaknesses in internal control over financial reporting, and outlines ongoing remediation efforts [Evaluation of Disclosure Controls and Procedures](index=40&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section reports on management's assessment of the effectiveness of disclosure controls and procedures - As of June 30, 2025, Envoy Medical's management, including the CEO and Interim CFO, concluded that disclosure controls and procedures were not effective due to material weaknesses in internal control over financial reporting[199](index=199&type=chunk) - Despite the material weaknesses, management believes the unaudited condensed consolidated financial statements fairly present the company's financial condition, results of operations, and cash flows in conformity with U.S. GAAP[200](index=200&type=chunk) [Material Weaknesses in Internal Control Over Financial Reporting](index=41&type=section&id=Material%20Weaknesses%20in%20Internal%20Control%20Over%20Financial%20Reporting) This section identifies significant deficiencies in internal controls and outlines remediation actions - Material weaknesses identified as of June 30, 2025, include insufficient accounting personnel, lack of a formal risk assessment (including cybersecurity and fraud), inadequate formal accounting policies and controls over significant accounts, and ineffective IT general controls[201](index=201&type=chunk) - Remediation measures are ongoing and include hiring additional accounting personnel, designing and implementing effective processes and controls, enhancing IT security and change management controls, and engaging advisory firms[203](index=203&type=chunk) [Changes in Internal Control Over Financial Reporting](index=41&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) This section reports on material changes in internal control over financial reporting during the quarter - Other than the appointment of an Interim Chief Financial Officer, there were no material changes in the company's internal control over financial reporting during the fiscal quarter ended June 30, 2025[202](index=202&type=chunk) [PART II. OTHER INFORMATION](index=42&type=section&id=PART%20II) This section provides additional disclosures not covered in financial statements, including legal and risk factors [ITEM 1. Legal Proceedings](index=42&type=section&id=ITEM%201.%20Legal%20Proceedings) This section discloses the ongoing legal proceedings against Envoy Medical, specifically a lawsuit filed by Atlas Merchant Capital SPAC Fund I LP - Envoy Medical is a defendant in a lawsuit filed by Atlas Merchant Capital SPAC Fund I LP, alleging that Atlas was improperly prevented from redeeming its shares and seeking approximately **$9.4 million** in damages[206](index=206&type=chunk) - The company believes the lawsuit is meritless and is vigorously defending the matter, unable to predict its outcome[206](index=206&type=chunk) [ITEM 1A. Risk Factors](index=42&type=section&id=ITEM%201A.%20Risk%20Factors) As a smaller reporting company, Envoy Medical refers readers to its Annual Report on Form 10-K for a comprehensive discussion of material risks, uncertainties, and other factors affecting the company - Envoy Medical, as a smaller reporting company, is not required to provide detailed risk factors in this report but refers to the 'Risk Factors' section in its Form 10-K filed on March 31, 2025, for a discussion of material risks[207](index=207&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=42&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds,%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section confirms that there were no unregistered sales of equity securities or issuer purchases of equity securities during the fiscal quarter ended June 30, 2025, that were not previously reported - During the fiscal quarter ended June 30, 2025, there were no unregistered sales of Envoy Medical's securities that were not reported in a Current Report on Form 8-K[208](index=208&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=42&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities during the reporting period[209](index=209&type=chunk) [ITEM 4. Mine Safety Disclosures](index=42&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to Envoy Medical - Mine safety disclosures are not applicable to Envoy Medical[210](index=210&type=chunk) [ITEM 5. Other Information](index=42&type=section&id=ITEM%205.%20Other%20Information) This section confirms that no director or officer adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the fiscal quarter - No director or officer of Envoy Medical adopted or terminated a 'Rule 10b5-1 trading arrangement' or a 'non-Rule 10b5-1 trading arrangement' during the fiscal quarter ended June 30, 2025[211](index=211&type=chunk) [ITEM 6. Exhibits](index=43&type=section&id=ITEM%206.%20Exhibits) This section provides a comprehensive list of exhibits filed with the Form 10-Q, including business combination agreements, corporate governance documents, warrant agreements, and certifications - The exhibit index lists various documents incorporated by reference, such as the Business Combination Agreement, Amended and Restated Certificate of Incorporation, Warrant Agreement, and certifications by the CEO and CFO[214](index=214&type=chunk) [PART III. SIGNATURES](index=45&type=section&id=PART%20III) This section contains the official certifications and signatures required for the Form 10-Q submission [SIGNATURES](index=45&type=section&id=SIGNATURES) This section contains the required signatures for the Form 10-Q, certifying its submission on behalf of Envoy Medical, Inc. by its principal executive and financial officers - The report is signed by Brent T. Lucas, Chief Executive Officer (Principal Executive Officer), and Robert Potashnick, Interim Chief Financial Officer (Principal Financial and Accounting Officer), on July 31, 2025[219](index=219&type=chunk)

● Strong momentum continues in the pivotal clinical trial of its investigational novel hearing device, the fully implanted Acclaim® cochlear implant. ● Successful activation of all 10 study participants' fully implanted Acclaim® cochlear implants in the first stage of the Company's pivotal clinical trial. ● All 10 of the study participants in the first stage of the Company's pivotal clinical trial have successfully completed their one- month follow-up visits. The visits are proceeding as expected and no ser ...

Core Insights - Envoy Medical reported positive progress in its clinical trials for the Acclaim® cochlear implant, with all 10 participants successfully activated and no serious adverse events reported [3][7] - The company anticipates significant market interest for the Acclaim® implant, which is positioned to disrupt the current hearing device market [3] - Changes in reimbursement policies for the Esteem® device could enhance market opportunities, as it is already FDA approved and unique in the marketplace [4] Financial Performance - Net revenues for the second quarter of 2025 increased by $10 thousand compared to the same period in 2024, reaching $78 thousand [5][20] - Research and development expenses decreased by $0.1 million to $2.485 million, reflecting a shift from development to clinical trials [6] - General and administrative expenses rose by $0.5 million, primarily due to a severance accrual [8] Clinical and Regulatory Developments - The Acclaim® cochlear implant received Breakthrough Device Designation from the FDA in 2019, indicating its potential significance in the market [12] - Five new Category III CPT codes for fully implantable active middle ear implants were approved, effective July 1, 2025, which may facilitate market adoption [7][16] - Envoy Medical was granted two new patents in the US and three in Australia, strengthening its intellectual property portfolio [7] Cash Flow and Financial Position - As of June 30, 2025, the company had approximately $5.3 million in cash [8] - The total liabilities increased to $39.759 million from $30.380 million at the end of 2024, indicating a rise in financial obligations [19] - The net loss for the second quarter was $5.690 million, compared to a loss of $3.947 million in the same quarter of the previous year [21]