UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, 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 March 31, 2025 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 oth ...

Financial Performance - Net revenues for the year ended December 31, 2024, decreased by $91 thousand to $225 thousand compared to $316 thousand in 2023, primarily due to a reduction in battery replacement sales caused by supply chain limitations [4]. - The company reported a net loss of $20.8 million for the year ended December 31, 2024, compared to a net loss of $29.9 million in 2023, with a net loss per share attributable to common stockholders of $1.49 [17]. - Net loss for the year ended December 31, 2024, was $20,795,000, a decrease from a net loss of $29,922,000 in 2023, representing a 30% improvement [19]. Cash and Liquidity - As of December 31, 2024, cash and cash equivalents were approximately $5.5 million, an increase from $4.2 million in 2023 [7]. - The company ended the year with cash of $5,483,000, up from $4,218,000 at the beginning of the year, reflecting a net increase of $1,265,000 [19]. - Cash provided by financing activities totaled $20,198,000 in 2024, compared to $21,282,000 in 2023, showing a decrease of approximately 5% [19]. - Net cash used in operating activities increased to $17,949,000 in 2024 from $17,091,000 in 2023, indicating a slight rise in cash outflow [19]. Expenses - Research and development expenses increased by $1.2 million to $10.2 million for the year ended December 31, 2024, primarily due to increased headcount in preparation for the pivotal clinical study for the Acclaim cochlear implant [5]. - General and administrative expenses decreased by $438 thousand to $6.8 million for the year ended December 31, 2024, primarily due to reduced professional service costs compared to 2023 [7]. - Depreciation expenses rose to $173,000 in 2024 from $133,000 in 2023, indicating a 30% increase [19]. - Stock-based compensation decreased significantly to $562,000 in 2024 from $1,575,000 in 2023, a reduction of about 64% [19]. Clinical Trials and Product Development - The company has enrolled six out of ten planned participants in the first stage of the pivotal clinical trial for the Acclaim cochlear implant, with two participants activated [3]. - The company has selected seven top-tier cochlear implant programs as investigational sites for the pivotal clinical trial of the Acclaim cochlear implant [3]. - The American Medical Association approved new CPT codes for totally implantable active middle ear hearing implants, which could enhance reimbursement opportunities for the Esteem device [3]. - The company continues to advocate for the Hearing Device Coverage Classification Act, which aims to clarify that implanted active middle ear implants are prosthetics eligible for Medicare coverage [3]. Assets and Liabilities - Total assets increased to $11.5 million as of December 31, 2024, compared to $8.3 million in 2023 [15]. - The company recorded a change in fair value of convertible notes payable of $13,332,000 in 2023, which was not present in 2024 [19]. - Proceeds from the issuance of term loans (related party) amounted to $20,000,000 in 2024, with no such proceeds reported in 2023 [19]. - The company incurred cash paid for interest of $41,000 in 2024, up from $26,000 in 2023, representing a 58% increase [19]. Non-Cash Activities - Non-cash investing activities included property and equipment purchased on account totaling $117,000 in 2024, with no such purchases reported in 2023 [20].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or (Mark One) ☐ 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) (State or other jurisdiction of incorp ...

Financial Performance - For the three months ended September 30, 2024, the company reported a net loss of approximately $6.0 million, compared to a net income of $1.6 million for the same period in 2023[146]. - The accumulated deficit as of September 30, 2024, was $277.5 million, up from $257.2 million as of December 31, 2023[146]. - The company expects to continue incurring net losses for the foreseeable future, driven by ongoing research and development and regulatory approval efforts[146]. - The company incurred a net loss of approximately $16.2 million for the nine months ended September 30, 2024, adjusted for non-cash expenses of approximately $2.2 million[190]. Revenue and Sales - Revenue is currently derived primarily from the sale of the Esteem FI-AMEI implants, with new implantations expected to be minimal, potentially as low as zero per year[152]. - Upon commercialization of the Acclaim CI, the company expects revenues to exceed those from the Esteem FI-AMEI[153]. - Net revenues decreased by $24 thousand (30.0%) for the three months and $38 thousand (17.2%) for the nine months ended September 30, 2024, primarily due to a decrease in battery replacements caused by supply chain issues[173]. Expenses - Research and development expenses are primarily focused on the development of the Acclaim CI, with significant increases expected as the product progresses[146]. - Research and development expenses increased by $907 thousand (49.0%) for the three months and $1.8 million (30.6%) for the nine months ended September 30, 2024, driven by increased headcount and contractors in engineering and clinical departments[175]. - General and administrative expenses rose by $665 thousand (64.8%) for the three months and $1.2 million (27.3%) for the nine months ended September 30, 2024, mainly due to increased personnel-related costs and professional fees[178]. - Sales and marketing expenses decreased by $5 thousand (1.3%) for the three months but increased by $63 thousand (5.5%) for the nine months ended September 30, 2024, attributed to higher legal and professional fees[176]. - Total costs and operating expenses increased by $1.6 million (45.2%) for the three months and $3.1 million (25.8%) for the nine months ended September 30, 2024, driven by higher R&D and administrative costs[172]. Operating Loss - Operating loss increased by $1.6 million (46.9%) for the three months and $3.1 million (26.6%) for the nine months ended September 30, 2024, reflecting higher costs and lower revenues[172]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2024 was $(13,561) thousand, compared to $(5,946) thousand for the same period in 2023[189]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $15,284 thousand, driven by $15 million proceeds from 2024 Term Loans and $1.7 million from the sale of common stock[192]. - The company had $4.4 million in cash as of September 30, 2024, compared to $4.2 million as of December 31, 2023[186]. - Net cash used in investing activities for the nine months ended September 30, 2024 was approximately $1.5 million, primarily for purchases of property and equipment[191]. Regulatory and Product Development - The Acclaim CI, the company's lead product candidate, received FDA approval for an Investigational Device Exemption in October 2024, allowing a staged clinical trial to begin[145]. - The company anticipates obtaining FDA's decision on the Premarket Approval for the Acclaim CI in 2027, although this timeline is uncertain[145]. - The company expects to incur significant operating losses for the foreseeable future as it advances clinical development and funds FDA trials[186]. Market Conditions - Macroeconomic conditions, including inflation and market uncertainty, have impacted the company's financial performance and ability to raise capital[149]. - The company may seek additional capital through public or private equity offerings, debt financings, and strategic alliances, with no assurance of success[188].

Exhibit 99.1 Envoy Medical Reports Third Quarter 2024 Results and Other Exciting Events FDA approval to begin pivotal trial of fully implanted cochlear implant and AMA approval of CPT codes for the Company's already FDA-approved fully implanted middle ear implant are two of the exciting developments for the growing company WHITE BEAR LAKE, Minn., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. ("Envoy Medical") (Nasdaq: COCH), a revolutionary hearing health company focused on fully implanted hearing ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 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 jurisdic ...

As filed with the Securities and Exchange Commission on April 25, 2024 Registration No. 333-276590 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 _____________________ Envoy Medical, Inc. (Exact name of registrant as specified in its charter) _____________________ | Delaware | 3842 | 86-1369123 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (IRS Employer | | ...

As filed with the Securities and Exchange Commission on April 5, 2024 Registration No. 333-276590 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 _____________________ Envoy Medical, Inc. (Exact name of registrant as specified in its charter) _____________________ | Delaware | 3842 | 86-1369123 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (IRS Employer | | i ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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) (State or other jurisdiction of incorp ...