Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
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.
On May 11, 2026, Envoy Medical, Inc. (the
“Company”), issued a press release regarding the Company’s financial results for its fiscal quarter ended March 31,
2026. A copy of the Company’s press release is attached hereto as Exhibit 99.1.
The information in this Item 2.02, including the
accompanying exhibit, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in
this Item 2.02 shall not be incorporated into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless
of any general incorporation language in such filing.
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Exhibit 99.1
Envoy Medical Reports Landmark Accomplishments,
Advancing Toward
FDA Approval of First-Of-Its-Kind Fully Implanted Cochlear Implant
Company Completes Historic Trial Enrollment,
Secures Transformational Financing, and
Sees Promising Early Clinical Data Presented at Industry Conferences
White Bear Lake, Minnesota – May 11,
2026 – Envoy Medical® Inc. (NASDAQ: COCH) (“Envoy Medical” or the “Company”), a hearing
health company pioneering fully implanted hearing solutions, today reported first quarter 2026 results and landmark achievements that
advance the Company another step closer toward commercialization of its investigational Acclaim® cochlear implant.
“The
first quarter of 2026 marked a transformative period for Envoy Medical, highlighted by the completion of enrollment in our pivotal clinical
trial and the successful execution of a significant financing,” said Brent Lucas, Chief Executive Officer of Envoy Medical.
“Achieving full enrollment in our pivotal clinical
study represents a critical step. We continue to be encouraged by the trial’s progress and remain focused on advancing toward PMA
submission and, ultimately, commercialization. With a substantially strengthened balance sheet and the support of leading healthcare investors,
we believe we are well positioned to execute on our strategic objectives and deliver on the roadmap ahead.”
Corporate and Financial Highlights for Q1 2026:
| ● | Pivotal
Trial Enrollment Complete — A First for the Industry |
In a defining milestone for the hearing health sector, Envoy
Medical became the first cochlear implant company to achieve full enrollment of a U.S. pivotal clinical trial evaluating a fully implanted
cochlear implant seeking FDA approval. The 56th and final patient was successfully implanted on March 11, 2026, completing enrollment
across U.S. sites. The Company is now collecting 12-month follow-up data from all participants, with a Premarket Approval (PMA) submission
to the FDA to follow.
| ● | Transformational
Capital Raise |
Envoy Medical closed an upsized public offering for up to
$78.0 million, including $30.0 million in gross proceeds at closing with up to an additional $48.0 million of potential aggregate gross
proceeds upon the exercise in full of milestone-linked warrants. The financing was led by Nantahala Capital and included healthcare-dedicated
funds such as Broadfin Holdings, as well as existing shareholders including members of the Board and management team.
| ● | Expanded
Intellectual Property Portfolio |
As of February 20, 2026, Envoy Medical has expanded its global
IP portfolio to 47 patents across North America, Europe, Asia, and Australia. In February alone, the Company secured three new patents
strengthening its competitive position in the fully implanted hearing space.
Highlights Subsequent to Q1 2026:
| ● | Promising
Early Clinical Data Presented |
Interim six-month clinical data from the first 10 patients
in the pivotal study showed no study-defined serious adverse events, mean CNC word recognition improved from 15.2% to 39.2%, median daily
device wear time of 24 hours, and improvements in quality-of-life and tinnitus scores. Initial safety and performance data for these 10
patients were presented at the American Academy of Audiology Annual Conference and the Combined Otolaryngology Spring Meetings.
| ● | All
56 Pivotal Trial Patients Activated |
Following the completion of enrollment, Envoy Medical confirmed
that all 56 patients implanted in the pivotal clinical trial have been activated. This milestone validates that the full patient cohort
is progressing through the study protocol on schedule, keeping the Company on track to collect the 12-month endpoint data required for
its planned PMA submission to the FDA.
Envoy Medical appointed medical device veteran Chas McKhann
to its Board of Directors in April 2026, further enhancing the Company’s expertise as it prepares to conclude its pivotal clinical
study and prepare for commercial launch.
| ● | First
Patients Reach 12-Month Endpoint |
The first three patients implanted in the pivotal trial successfully
completed their 12-month endpoint visit, marking a key milestone in the study’s progress. The primary endpoints for the trial are tied
to 12-month data, and achieving this critical milestone on schedule underscores the Company’s continued execution as it steadily marches
toward PMA submission and commercialization.
Financial Results for the Quarter Ended March 31, 2026 (dollars
in thousands):
Net Revenue was $39 for the three months ended March 31, 2026.
Cost of goods sold for the three months ended March 31, 2026, were
$313, compared to $226. The $87 increase is primarily due to higher scrap and materials usage as well as increased fees for third-parties
performing work related to our products.
R&D expenses for the three months ended March 31, 2026, were $3,642
compared to $2,748 for the three months ended March 31, 2025. This increase of $894 mainly reflects additional clinical trial activity
and related personnel costs during enrollment.
Sales and marketing expenses for the three months ended March 31, 2026,
were $164 compared to $358 for the three months ended March 31, 2025. The decrease of $194 is primarily due to the reallocation of resources
to research and development activities in support of the clinical trial.
General and administrative expenses are $1,879 for the three months
ended March 31, 2026, compared to $1,821 for the three months ended March 31, 2025. The increase of $58 was primarily due to higher investor
relations and legal expenses.
As of March 31, 2026, cash was approximately $25,251.
The Acclaim® cochlear implant
received Breakthrough Device Designation from the FDA in 2019 and is currently under investigation as part of a U.S. based pivotal clinical
trial. For more information on the trial, visit www.envoymedical.com/acclaim-pivotal.
To be added to the Envoy Medical email distribution list, please email
Envoy@kcsa.com with COCH in the subject line.
About Envoy Medical, Inc.
Envoy Medical (NASDAQ: COCH) is a
hearing health company focused on providing innovative technologies across the hearing loss spectrum. Envoy Medical has pioneered one-of-a-kind,
fully implanted devices for hearing loss, including its fully implanted Esteem® active middle ear implant, commercially available
in the U.S. since 2010, and the fully implanted Acclaim® cochlear implant, an investigational device. Envoy Medical is dedicated
to pushing hearing technology beyond the status quo to improve access, usability, compliance, and ultimately quality of life.
About the Fully Implanted Acclaim® Cochlear Implant
We believe
the fully implanted Acclaim Cochlear Implant (“Acclaim CI”) is a first-of-its-kind hearing device. 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 is expected to be indicated for adults who have been deemed
adequate candidates by a qualified physician.
The Acclaim Cochlear Implant received the Breakthrough Device Designation
from the U.S. Food and Drug Administration (FDA) in 2019.
CAUTION The fully implanted Acclaim Cochlear Implant is an investigational
device. Limited by Federal (or United States) law to investigational use.
About the Esteem® Fully Implanted
Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted*
hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the
ear’s natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed
in the ear canal for it to function. Unlike hearing aids, you never put it on or take it off. You can’t lose it. You don’t clean it.
The Esteem FI-AMEI hearing implant offers true 24/7 hearing.
*Once activated, the external Esteem FI-AMEI Personal Programmer is
not required for daily use.
Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.
Additional Information and Where to Find It
Copies of the documents
filed by Envoy Medical with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov.
Forward-Looking Statements
This press release includes “forward-looking
statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform
Act of 1995. Forward-Looking statements may be identified by the use of words such as “estimate,” “plan,” “project,”
“forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,”
“target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical
matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not
limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals
for future operations; the ability to obtain additional patents and develop future products or product improvements; the ability to maintain
compliance with Nasdaq rules and requirements; the timing and future outcome of its FDA pivotal trial; the ability to raise capital and
the amount of capital required to complete the FDA pivotal trial and early commercialization; the Acclaim CI being the first to market
fully implanted cochlear implant; the timing and results of activations, enrollments, follow-up visits, data, and clinical trials of
the Acclaim CI; and the participation or any changes or delays in participation of any subjects, institutions, or healthcare professionals
in such trials; the safety, performance, and market acceptance of the Acclaim CI; the timing and results of the Acclaim CI’s PMA submission
to the FDA; the size of Envoy Medical’s addressable market, operational performance, future market conditions or economic performance
and developments in the capital and credit markets; and any information concerning possible or assumed future operations of Envoy Medical.
The forward-looking statements contained in this press release reflect Envoy Medical’s current views about future events and are subject
to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ
significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the events described will
happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties,
including, but not limited to changes in the market price of shares of Envoy Medical’s Class A Common Stock; changes in or removal of
Envoy Medical’s shares inclusion in any index; Envoy Medical’s success in retaining or recruiting, or changes required in, its officers,
key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the
clinical development process of Envoy Medical products; the ability to engage competition in the medical device industry, and the failure
to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; disruptions
in relationships with Envoy Medical’s suppliers, or disruptions in Envoy Medical’s own production capabilities for some of the key components
and materials of its products; changes in the need for capital and the availability of financing and capital to fund these needs; changes
in interest rates or rates of inflation; legal, regulatory and other proceedings could be costly and time-consuming to defend; changes
in applicable laws or regulations, or the application thereof on Envoy Medical; a loss of any of Envoy Medical’s key intellectual property
rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and
other international conflicts; and other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary
Note Regarding Forward-Looking Statements” in the Annual Report on Form 10-K filed by Envoy Medical on March 23, 2026, and in other
reports Envoy Medical files, with the SEC. If any of these risks materialize or Envoy Medical’s assumptions prove incorrect, actual results
could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy
Medical’s good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update
or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future
events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance
on any forward-looking statements, which are based only on information currently available to Envoy Medical.
Investor Contact:
Phil Carlson
KCSA Strategic Communications
O: 212.896.1233
E: Envoy@kcsa.com
Media Contact:
Anne Donohoe
KCSA Strategic Communications
O: 732-620-0033
E: Envoy@kcsa.com
ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share amounts)
| | |
March 31, | | |
December 31, | |
| | |
2026 | | |
2025 | |
| | |
| | |
| |
| Current assets: | |
| | |
| |
| Cash | |
$ | 25,251 | | |
$ | 3,739 | |
| Accounts receivable, net | |
| 31 | | |
| 34 | |
| Other receivable | |
| 17 | | |
| 19 | |
| Inventories | |
| 1,490 | | |
| 1,546 | |
| Prepaid expenses and other current assets | |
| 893 | | |
| 941 | |
| Total current assets | |
| 27,682 | | |
| 6,279 | |
| Property and equipment, net | |
| 962 | | |
| 1,035 | |
| Operating lease right-of-use asset (related party) | |
| 853 | | |
| 886 | |
| Prepaid expenses and other assets | |
| 325 | | |
| 358 | |
| Total assets | |
$ | 29,822 | | |
$ | 8,558 | |
| | |
| | | |
| | |
| Liabilities, mezzanine equity, and stockholders’ equity (deficit) | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 1,700 | | |
$ | 2,920 | |
| Accrued expenses | |
| 9,653 | | |
| 7,639 | |
| Forward purchase agreement warrant liability | |
| 37 | | |
| 24 | |
| Product warranty liability, current portion | |
| 264 | | |
| 287 | |
| Operating lease liability, current portion (related party) | |
| 178 | | |
| 174 | |
| Other current liabilities | |
| 379 | | |
| 518 | |
| Total current liabilities | |
| 12,211 | | |
| 11,562 | |
| Product warranty liability, net of current portion | |
| 1,550 | | |
| 1,605 | |
| Operating lease liability, net of current portion (related party) | |
| 711 | | |
| 745 | |
| Private warrant liability | |
| 3,830 | | |
| 5,835 | |
| Publicly traded warrant liability | |
| 941 | | |
| 551 | |
| Other liability | |
| 27 | | |
| 27 | |
| Total liabilities | |
| 19,270 | | |
| 20,325 | |
| | |
| | | |
| | |
| Commitments and contingencies (see Note 13) | |
| | | |
| | |
| | |
| | | |
| | |
| 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 March 31, 2026 and December 31, 2025; 4,126,667 shares issued and outstanding as of March 31, 2026 and December 31, 2025 | |
| - | | |
| - | |
| Class A Common Stock, $0.0001 par value; 400,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 76,881,110 shares issued and outstanding as of March 31, 2026 and 28,934,960 shares issued and outstanding as of December 31, 2025 | |
| 8 | | |
| 3 | |
| Additional paid-in capital | |
| 329,371 | | |
| 301,355 | |
| Accumulated deficit | |
| (319,097 | ) | |
| (313,396 | ) |
| Accumulated other comprehensive loss | |
| (121 | ) | |
| (120 | ) |
| Total stockholders’ equity (deficit) | |
| 10,161 | | |
| (12,158 | ) |
| Total liabilities, mezzanine equity, and stockholders’ equity (deficit) | |
$ | 29,822 | | |
$ | 8,558 | |
ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
(UNAUDITED)
(In thousands, except share and per share amounts)
| | |
Three Months Ended | |
| | |
March 31, | |
| | |
2026 | | |
2025 | |
| Net revenues | |
$ | 39 | | |
$ | 46 | |
| Costs and operating expenses: | |
| | | |
| | |
| Cost of goods sold | |
| 313 | | |
| 226 | |
| Research and development | |
| 3,642 | | |
| 2,748 | |
| Sales and marketing | |
| 164 | | |
| 358 | |
| General and administrative | |
| 1,879 | | |
| 1,821 | |
| Total costs and operating expenses | |
| 5,998 | | |
| 5,153 | |
| Operating loss | |
| (5,959 | ) | |
| (5,107 | ) |
| Other income (expense): | |
| | | |
| | |
| Change in fair value of forward purchase agreement warrant liability | |
| (13 | ) | |
| 421 | |
| Loss on offering and change in fair value of private warrant liability | |
| 2,005 | | |
| - | |
| Change in fair value of publicly traded warrant liability | |
| (390 | ) | |
| 194 | |
| Interest expense (related party) | |
| - | | |
| (495 | ) |
| Other income (expense), net | |
| 6 | | |
| (11 | ) |
| Total other income (expense), net | |
| 1,608 | | |
| 109 | |
| Net loss | |
| (4,351 | ) | |
| (4,998 | ) |
| | |
| | | |
| | |
| Cumulative preferred dividends | |
| (1,350 | ) | |
| (1,238 | ) |
| | |
| | | |
| | |
| Net loss attributable to common stockholders, basic and diluted | |
$ | (5,701 | ) | |
$ | (6,236 | ) |
| Net loss per share attributable to common stockholders, basic and diluted | |
$ | (0.08 | ) | |
$ | (0.29 | ) |
| Weighted-average Class A Common Stock and pre-funded warrants outstanding, basic and diluted | |
| 68,934,960 | | |
| 21,326,609 | |
| Other comprehensive (loss) income: | |
| | | |
| | |
| Foreign currency translation adjustment | |
| (1 | ) | |
| 6 | |
| Other comprehensive (loss) income | |
| (1 | ) | |
| 6 | |
| Comprehensive loss | |
$ | (4,352 | ) | |
$ | (4,992 | ) |
ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(Dollars in thousands)
| | |
Three Months Ended | |
| | |
March 31, | |
| | |
2026 | | |
2025 | |
| Cash flows from operating activities | |
| | |
| |
| Net loss | |
$ | (4,351 | ) | |
$ | (4,998 | ) |
| Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
| Depreciation | |
| 73 | | |
| 61 | |
| Interest expense and amortization of debt discount on Term Loans (related party) | |
| - | | |
| 495 | |
| Stock-based compensation for services | |
| 44 | | |
| - | |
| Amortization of prepaid insurance | |
| 227 | | |
| 247 | |
| Stock-based compensation | |
| 239 | | |
| 160 | |
| Loss on offering and change in fair value of private warrant liability | |
| (2,005 | ) | |
| - | |
| Change in fair value of publicly traded warrant liability | |
| 390 | | |
| (194 | ) |
| Change in fair value of forward purchase agreement warrant liability | |
| 13 | | |
| (421 | ) |
| Net change in operating lease (related party) | |
| 55 | | |
| 26 | |
| Change in inventory reserve | |
| 12 | | |
| (23 | ) |
| Changes in operating assets and liabilities: | |
| | | |
| | |
| Accounts receivable, net | |
| 3 | | |
| (4 | ) |
| Other receivable | |
| 2 | | |
| 757 | |
| Inventories | |
| 44 | | |
| 74 | |
| Prepaid expenses and other current assets | |
| (121 | ) | |
| (75 | ) |
| Accounts payable | |
| (1,220 | ) | |
| 10 | |
| Operating lease liability (related party) | |
| (52 | ) | |
| (22 | ) |
| Accrued expenses | |
| 664 | | |
| 199 | |
| Product warranty liability | |
| (78 | ) | |
| (17 | ) |
| Net cash used in operating activities | |
| (6,061 | ) | |
| (3,725 | ) |
| | |
| | | |
| | |
| Cash flows from investing activities | |
| | | |
| | |
| Purchases of property and equipment | |
| - | | |
| (6 | ) |
| Net cash used in investing activities | |
| - | | |
| (6 | ) |
| | |
| | | |
| | |
| Cash flows from financing activities | |
| | | |
| | |
| Payments on insurance financing loans | |
| (208 | ) | |
| (233 | ) |
| Proceeds from the issuance of Term Loans (related party) | |
| - | | |
| 5,000 | |
| Dividends paid to stockholders of Series A Preferred Stock | |
| - | | |
| (1,213 | ) |
| 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 | |
| 27,574 | | |
| 3,554 | |
| | |
| | | |
| | |
| Effect of exchange rate changes on cash | |
| (1 | ) | |
| 6 | |
| Net (decrease) increase in cash | |
| 21,512 | | |
| (171 | ) |
| Cash, beginning of period | |
| 3,739 | | |
| 5,483 | |
| Cash, end of period | |
$ | 25,251 | | |
$ | 5,312 | |
| | |
| | | |
| | |
| Supplemental disclosures of cash flow information: | |
| | | |
| | |
| Cash paid for interest | |
$ | 11 | | |
$ | 13 | |
| Non-cash investing and financing activities: | |
| | | |
| | |
| Accrued and unpaid dividends on Series A Preferred Stock | |
$ | 1,350 | | |
$ | 25 | |
| Financing of prepaid insurance | |
$ | 69 | | |
$ | 75 | |
| Issuance of Term Loan Warrants (related party) | |
$ | - | | |
$ | 688 | |
| Issuance of Placement Agent Warrants | |
$ | 678 | | |
$ | - | |
7
