Filed Pursuant to Rule 424(b)(3)
Registration No. 333-276590
PROSPECTUS SUPPLEMENT NO. 7
To Prospectus dated May 2, 2024
Up to 18,041,060 Shares of Class A Common Stock
Issuable Upon Exercise of Warrants
Up to 3,913,043 Shares of Class A Common Stock
Issuable Upon Conversion of Series A Preferred Stock
13,418,923 Shares of Class A Common Stock
3,874,394 Warrants
This prospectus supplement
no. 7 supplements the prospectus dated May 2, 2024 (the “Prospectus”), which forms a part of the Registration Statement
on Form S-1 (Registration No. 333-276590). Capitalized terms used in this prospectus supplement and not otherwise defined herein have
the meanings specified in the Prospectus.
The Prospectus relates to
the issuance by us of up to an aggregate of 21,954,103 shares of our Class A Common Stock, consisting of (i) up to 14,166,666 shares of
Class A Common Stock that are issuable upon the exercise of 14,166,666 Public Warrants originally issued by our predecessor company, Anzu,
as part of its IPO of units at a price of $10.00 per unit, with each unit consisting of one share of Anzu Class A Common Stock and one-third
of one Public Warrant; (ii) up to 3,874,394 shares of Class A Common Stock that are issuable upon the exercise of 3,874,394 Shortfall
Warrants issued to the Meteora FPA Parties for no additional consideration pursuant to the Forward Purchase Agreement; up to 2,173,913
shares of Class A Common Stock issuable upon conversion of 2,500,000 shares of our Series A Convertible Preferred Stock, issued to the
Sponsor concurrently with the Closing in a private exchange offer for 2,500,000 shares of Anzu’s Class B Common Stock, originally
issued in connection with the IPO at a price of $0.002 per share; (iv) up to 869,565 shares of Class A Common Stock issuable upon conversion
of an aggregate of 1,000,000 shares of Series A Preferred Stock, which were issued to the PIPE Investors, each an affiliate of the Sponsor,
in connection with the Closing at a price of $10.00 per share and have a conversion price of $11.50 per share; and (v) up to 869,565 shares
of Class A Common Stock issuable upon conversion of 1,000,000 shares of Series A Preferred Stock, which were issued to GAT in connection
with the Closing in exchange for the Legacy Envoy Bridge Note at a price of $10.00 per share and have a conversion price of $11.50 per
share. We will receive the proceeds from any exercise of any Warrants, assuming the exercise in full of all of the Warrants for cash,
but not from the sale of the shares of Class A Common Stock issuable upon such exercise.
The Prospectus and prospectus
supplement also relate to the offer and sale from time to time by the Selling Securityholders named in the Prospectus of up to 3,874,394
Shortfall Warrants and up to 21,206,360 shares of Class A Common Stock, consisting of (i) up to 3,874,394 shares of Class A Common Stock
that are issuable upon the exercise of 3,874,394 Shortfall Warrants issued to the Meteora FPA Parties for no additional consideration
pursuant to the Forward Purchase Agreement; (ii) up to 2,173,913 shares of Class A Common Stock issuable upon conversion of 2,500,000
shares of Series A Preferred Stock, which were issued to the Sponsor concurrently with the Closing in a private exchange offer for 2,500,000
shares of Anzu Class B Common Stock originally issued in connection with the IPO at a price of $0.002 per share and have a conversion
price of $11.50 per share; (iii) up to 869,565 shares of Class A Common Stock issuable upon conversion of an aggregate of 1,000,000 shares
of Series A Preferred Stock, which were issued to the PIPE Investors in connection with the Closing at a price of $10.00 per share and
have a conversion price of $11.50 per share; (iv) up to 869,565 shares of Class A Common Stock issuable upon conversion of 1,000,000 shares
of Series A Preferred Stock, which were issued to GAT in connection with the Closing in exchange for the Legacy Envoy Bridge Note at a
price of $10.00 per share and have a conversion price of $11.50 per share; (v) 2,000,000 shares of Class A Common Stock (1,000,000 of
which remain unvested and subject to forfeiture and will vest upon the approval from the United States Food and Drug Administration of
the Acclaim CI or upon a change of control of the Company) issued to the Sponsor concurrently with the Closing upon conversion of 2,000,000
shares of Anzu Class B Common Stock originally issued in connection with the IPO at a price of $0.002 per share; (vi) an aggregate of
125,000 shares of Class A Common Stock issued to Anzu’s former directors concurrently with the Closing upon conversion of 125,000
shares of Anzu Class B Common Stock originally issued in connection with the IPO at a price of $0.002 per share; (vii) an aggregate of
490,000 shares of Class A Common Stock issued to the Sponsor concurrently with the Closing upon conversion of 490,000 shares of Anzu Class
B Common Stock and subsequently transferred by the Sponsor to certain third parties for no additional consideration pursuant to (a) side
letter agreements, dated December 6, 2021, by and between the Sponsor and certain institutional investors and (b) extension support agreements,
by and among Anzu, the Sponsor and several unaffiliated third parties; (viii) an aggregate of 8,512 shares of Class A Common Stock issued
to the Meteora FPA Parties concurrently with the Closing for no additional consideration pursuant to the Forward Purchase Agreement; and
(ix) an aggregate of 10,795,411 shares of Class A Common Stock issued to the Key Seller Stockholders concurrently with the Closing, and
as consideration in the Business Combination, upon the conversion of an aggregate of 169,731,160 shares of Legacy Envoy Common Stock held
by the Key Seller Stockholders into shares of Class A Common Stock. We will not receive any proceeds from the sale of Shortfall Warrants
or Class A Common Stock by the Selling Securityholders pursuant to the Prospectus.
We registered the securities
for resale pursuant to the Selling Securityholders’ registration rights under certain agreements between us and the Selling Securityholders.
Our registration of the securities covered by the Prospectus does not mean that the Selling Securityholders will offer or sell any of
their Shortfall Warrants or Class A Common Stock. The Selling Securityholders may offer, sell or distribute all or a portion of their
Shortfall Warrants and Class A Common Stock publicly or through private transactions at prevailing market prices or at negotiated prices.
We will not receive any proceeds from the sale of Shortfall Warrants or Class A Common Stock by the Selling Securityholders pursuant to
the Prospectus. We provide more information about how the Selling Securityholders may sell their Shortfall Warrants and Class A Common
Stock in the section entitled “Plan of Distribution.”
This prospectus supplement
incorporates into the Prospectus the information contained in our attached current report on Form 8-K, which was filed with the Securities
and Exchange Commission on August 12, 2024.
You should read this prospectus
supplement in conjunction with the Prospectus, including any supplements and amendments thereto. This prospectus supplement is qualified
by reference to the Prospectus except to the extent that the information in the prospectus supplement supersedes the information contained
in the Prospectus. This prospectus supplement is not complete without, and may not be delivered or utilized except in connection with,
the Prospectus, including any supplements and amendments thereto.
Our Class A Common Stock
and Public Warrants are listed on The Nasdaq Capital Market under the symbols “COCH” and “COCHW,” respectively.
On August 9, 2024, the closing price of our Class A Common Stock was $2.26 and the closing price for our Public Warrants was $0.08.
See the section entitled “Risk
Factors” beginning on page 10 of the Prospectus to read about factors you should consider before buying our securities.
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities or determined if this prospectus supplement of the
Prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus supplement is August 12,
2024.
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): August 12, 2024
ENVOY
MEDICAL, INC.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-40133 |
|
86-1369123 |
(State
or other jurisdiction
of incorporation) |
|
(Commission File
Number) |
|
(IRS
Employer
Identification No.) |
4875
White Bear Parkway
White Bear Lake, MN |
|
55110 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (877) 900-3277
Not
Applicable
(Former
name or former address, if changed since last report)
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:
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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 whole Warrant
exercisable for one share of Class A Common Stock at an exercise price of $11.50 per share |
|
COCHW |
|
The
Nasdaq Stock Market LLC |
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).
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. ☐
Item
2.02. Results of Operations and Financial Condition.
On
August 12, 2024, Envoy Medical, Inc. (the “Company”), issued a press release regarding the Company’s financial results
for its second fiscal quarter ended June 30, 2024. 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.
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURES
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.
| |
ENVOY MEDICAL,
INC. |
| |
|
|
| August 12, 2024 |
By: |
/s/
David R. Wells |
| |
|
David R. Wells |
| |
|
Chief Financial Officer |
Exhibit
99.1
Envoy
Medical Reports Second Quarter 2024 Results and Provides Business Update
Company
continues to make significant progress towards disrupting the existing cochlear implant industry with its investigational, breakthrough
fully implanted Acclaim® cochlear implant; Maintains goal of starting Pivotal Clinical Trial by end of the year
WHITE
BEAR LAKE, Minn., August 12, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (Nasdaq: COCH),
a revolutionary hearing health company focused on fully implanted hearing devices, today announces its corporate and financial results
for the second quarter ended June 30, 2024.
“We
are pleased with the steady progress that Envoy Medical has made this quarter and year-to-date in advancing our goal of becoming a leading
cochlear implant company,” commented Brent T. Lucas, Envoy Medical’s Chief Executive Officer. “We believe the results
of our Early Feasibility Study justify further study of our breakthrough fully implanted cochlear implant and intend to submit an IDE
application to begin a Pivotal Clinical Trial in the coming months. If our IDE application is approved, we are hopeful that we may begin
enrolling the study before year-end.”
Corporate
Highlights from Q2 2024
Update
on Early Feasibility Study (EFS) at Mayo Clinic
| ● | Each
of the three participants in the ongoing Early Feasibility Study (EFS) at Mayo Clinic (Rochester,
MN) have now completed their 18-month follow up visits, continue to be enrolled in the study,
and report using their investigational Acclaim cochlear implant daily. All participants show
improvement in their global quality-of-life scores (via the CIQOL) after 18 months. |
| ● | There
have been neither serious adverse device effects (SADEs) nor unanticipated adverse device
effects (UADEs) as defined reported to date. There have been other adverse events (AEs) and
two revision surgeries – one revision for two participants – to replace the Acclaim
Battery with an updated design. |
| ● | Following
18 months of data collection supporting that the investigational device is capable of delivering
electrical stimulation to the cochlea, the Company believes there is strong justification
to move forward to a pivotal clinical study. |
Update
on System Noise
| ● | The
Company previously communicated that an internal ‘system noise’ hindered the
ability to optimize programming of the investigational Acclaim CI device. It was also noted
that this system noise does not appear to be ‘body noise,’ which is an outcome
that has been reported by other companies attempting fully implanted cochlear implants using
sub-dermal microphones – a different architecture than the Acclaim CI device. |
| ● | The
Company reports that mitigations and updates have been implemented to reduce system noise,
support meaningful improvements to the signal-to-noise ratio, and allow for increased programming
optimization. In addition, it is reasonable that further iterations may be implemented to
facilitate improved performance, as is commonplace as medical devices evolve. |
“AcclaimPlus”
Listening Condition Update
| ● | One
of the outcomes from the EFS was the realization of a potentially meaningful “listening
condition.” The Acclaim’s fundamental architecture is designed to pick up sound
from the ear itself and therefore allows devices – like hearing aids or consumer electronics
– to be used in the ear. Patients that would like to use a similar ‘listening
condition’ in everyday life, may choose an option that allows for such flexibility.
|
| ● | Two
participants chose to wear their hearing aid in the “Acclaim ear” during the
daytime during their participation in the EFS study. At first, this was primarily to mitigate
the system noise. Preliminary data supports that the hearing aid appears to provide additional
gain to the system enabling a better signal to noise ratio, as well as allowing the participants
to enjoy features of the third-party hearing aids such as direct streaming audio and phone
calls. It is possible that some patients will wear a hearing aid in their “Acclaim
ear” to provide the system with more gain and/or to take advantage of certain hearing
aid features. This dataset did not show that the hearing aid provided meaningful acoustic
amplification on its own. Although a small dataset and preliminary, the interim results of
the AcclaimPlus listening condition are encouraging and informative. |
| ● | One
participant chooses to use the Acclaim implant alone at all times. This participant’s
results were also encouraging and informative. |
| ● | The
Company believes that the flexibility patients may have with the fully implanted Acclaim
cochlear implant to use electronic devices and accessories in the implanted ear due to its
design and fundamental architecture could provide interesting opportunities and preferred
features for patients. It could also be an important differentiator for the fully implanted
Acclaim cochlear implant over other competitive devices. |
Timeline
Update
| ● | Envoy
Medical maintains its goal of submitting an application for an Investigational Device Exemption
(IDE) in the next few months. The company is optimistic that it can begin to enroll that
study, should it be approved, by year-end 2024. |
| ● | The
Company will provide more details on study design once approval is granted to begin the study. |
| ● | Assuming
approval, the Company maintains its view that commercialization may be achievable by the
end of 2026. |
Financial
Results for the Quarter Ended June 30, 2024
Revenue
was $68 thousand compared to $63 thousand for the same period in 2023. The increase is attributable to the sale of two Esteem FI-AMEI
units during the period, which offset reduced battery sales due to supply chain issues.
Cost
of goods sold increased by $83 thousand for the same period in 2023. The increase is attributable to manufacturing and materials scrap
for the Esteem FI-AMEI product of $62 thousand, additional contractors for manufacturing technicians and quality inspections of $20 thousand.
and supplies for the newly expanded manufacturing space of $11 thousand with offsets from other costs of $10 thousand.
R&D
expenses increased approximately $438 thousand to $2.6 million for the three months ended June 30, 2024 compared to the same period in
2023. The increase is primarily due to an increase in headcount and contractors in the engineering and clinical departments for the three
months ended June 30, 2024, as the Company increased headcount across its clinical and cochlear departments in preparation for its pivotal
clinical study for the Acclaim CI.
Sales
and marketing expenses increased by approximately $114 thousand to $497 thousand for the three months ended June 30, 2024 as compared
to the same period in 2023. The increase was primarily due to increased market access fees to secure insurance reimbursement
for the Esteem FI-AMEI product, offset by a reduction in headcount in that department.
General
and administrative expenses decreased by $250 thousand to $1.6 million compared to the same period in 2023. The reduction is due
primarily to reduced professional and legal fees related to the closing of the Business Combination in 2023 of $951 thousand, and
was partially offset by increases in personnel-related costs of $198 thousand, directors and officers insurance of $175 thousand,
non-cash stock option expenses of $99 thousand, loss on lease modification of $135 thousand, and other operating costs of $94
thousand, for the three months ended June 30, 2024.
As
of June 30, 2024, the Company had cash and cash equivalents of approximately $1.7 million.
About
the Fully Implanted Acclaim® Cochlear Implant
The
Company believes the fully implanted Acclaim CI will be a first-of-its-kind fully implanted cochlear implant. Envoy Medical’s fully
implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound.
The
Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The
Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified ear surgeon and audiologist.
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 capable of delivering 24/7 hearing capability using the ear’s natural anatomy.
The Esteem FI-AMEI 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.
| * | 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 operational improvements and capital
investments, the availability and benefits of future funding, the Acclaim CI being the first to market fully implanted cochlear implant,
the timing of Envoy Medical’s IDE submission and beginning of its clinical trial, the effect of such clinical trial on the development
of Envoy Medical’s business, the impact of proposed legislation on the hearing health market, reimbursement for the Esteem FI-AMEI
device, and the Envoy Medical business, and future market conditions or economic performance, as well as 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 transactions and 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; 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; 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 April
1, 2024, 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:
CoreIR
516-222-2560
investorrelations@envoymedical.com
ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share amounts)
| | |
June 30,
2024 | | |
December 31,
2023 | |
| Assets | |
| | |
| |
| Current assets: | |
| | |
| |
| Cash | |
$ | 1,746 | | |
$ | 4,218 | |
| Accounts receivable | |
| 174 | | |
| 70 | |
| Other receivables | |
| 28 | | |
| 176 | |
| Inventories | |
| 1,582 | | |
| 1,404 | |
| Prepaid expenses and other current assets | |
| 1,466 | | |
| 957 | |
| Total current assets | |
| 4,996 | | |
| 6,825 | |
| Property and equipment, net | |
| 632 | | |
| 351 | |
| Operating lease right-of-use assets (related party) | |
| 1,109 | | |
| 464 | |
| Total assets | |
$ | 6,737 | | |
$ | 7,640 | |
| | |
| | | |
| | |
| Liabilities and stockholders’ deficit | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 1,589 | | |
$ | 1,554 | |
| Accrued expenses | |
| 6,004 | | |
| 4,613 | |
| Product warranty liability, current portion | |
| 290 | | |
| 311 | |
| Operating lease liabilities (related party), current portion | |
| 175 | | |
| 158 | |
| Total current liabilities | |
| 8,058 | | |
| 6,636 | |
| Term loan payable (related party) | |
| 7,292 | | |
| — | |
| Product warranty liability, net of current portion | |
| 1,923 | | |
| 1,923 | |
| Operating lease liabilities (related party), net of current portion | |
| 1,121 | | |
| 404 | |
| Publicly traded warrant liability | |
| 708 | | |
| 332 | |
| Forward purchase agreement put option liability | |
| — | | |
| 103 | |
| Forward purchase agreement warrant liability | |
| 22 | | |
| 4 | |
| Total liabilities | |
| 19,124 | | |
| 9,402 | |
| | |
| | | |
| | |
| Commitments and contingencies (see Note 14) | |
| | | |
| | |
| | |
| | | |
| | |
| Stockholders’ deficit: | |
| | | |
| | |
| Series A Preferred Stock, $0.0001 par value; 10,000,000 shares authorized as of June 30, 2024 and December 31, 2023, respectively; 4,500,000 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | |
| — | | |
| — | |
| Class A Common Stock, $0.0001 par value; 400,000,000 shares authorized as of June 30, 2024 and December 31, 2023 respectively; 19,599,982 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | |
| 2 | | |
| 2 | |
| Additional paid-in capital | |
| 257,920 | | |
| 255,596 | |
| Accumulated deficit | |
| (270,189 | ) | |
| (257,242 | ) |
| Accumulated other comprehensive loss | |
| (120 | ) | |
| (118 | ) |
| Total stockholders’ deficit | |
| (12,387 | ) | |
| (1,762 | ) |
| Total liabilities and stockholders’ deficit | |
$ | 6,737 | | |
$ | 7,640 | |
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
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, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| Net revenues | |
$ | 68 | | |
$ | 63 | | |
$ | 127 | | |
$ | 141 | |
| Cost and operating expenses: | |
| | | |
| | | |
| | | |
| | |
| Cost of goods sold | |
| 245 | | |
| 162 | | |
| 398 | | |
| 337 | |
| Research and development | |
| 2,591 | | |
| 2,153 | | |
| 4,951 | | |
| 4,080 | |
| Sales and marketing | |
| 497 | | |
| 383 | | |
| 822 | | |
| 754 | |
| General and administrative | |
| 1,595 | | |
| 1,845 | | |
| 3,714 | | |
| 3,221 | |
| Total costs and operating expenses | |
| 4,928 | | |
| 4,543 | | |
| 9,885 | | |
| 8,392 | |
| Operating loss | |
| (4,860 | ) | |
| (4,480 | ) | |
| (9,758 | ) | |
| (8,251 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Other income (expense): | |
| | | |
| | | |
| | | |
| | |
| Loss from changes in fair value of convertible notes payable (related party) | |
| — | | |
| (8,766 | ) | |
| — | | |
| (18,143 | ) |
| Change in fair value of forward purchase agreement put option liability | |
| — | | |
| — | | |
| 103 | | |
| — | |
| Change in fair value of forward purchase agreement warrant liability | |
| 244 | | |
| — | | |
| (18 | ) | |
| — | |
| Change in fair value of publicly traded warrant liability | |
| 801 | | |
| — | | |
| (376 | ) | |
| — | |
| Interest expense, related party | |
| (132 | ) | |
| — | | |
| (168 | ) | |
| — | |
| Other expense | |
| — | | |
| — | | |
| — | | |
| (105 | ) |
| Total other income (expense), net | |
| 913 | | |
| (8,766 | ) | |
| (459 | ) | |
| (18,248 | ) |
| Net loss | |
$ | (3,947 | ) | |
$ | (13,246 | ) | |
$ | (10,217 | ) | |
$ | (26,499 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Accrued preferred stock dividend | |
$ | (1,365 | ) | |
$ | — | | |
$ | (2,730 | ) | |
$ | — | |
| | |
| | | |
| | | |
| | | |
| | |
| Net loss attributable to common stockholders, basic and diluted | |
$ | (5,312 | ) | |
$ | (13,246 | ) | |
$ | (12,947 | ) | |
$ | (26,499 | ) |
| Net loss per share attributable to common stockholders, basic and diluted | |
$ | (0.27 | ) | |
$ | (1.31 | ) | |
$ | (0.66 | ) | |
$ | (2.62 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted-average common stock outstanding, basic and diluted | |
| 19,599,982 | | |
| 10,122,581 | | |
| 19,599,982 | | |
| 10,122,581 | |
| | |
| | | |
| | | |
| | | |
| | |
| Other comprehensive loss: | |
| | | |
| | | |
| | | |
| | |
| Foreign currency translation adjustment | |
| (1 | ) | |
| (1 | ) | |
| (2 | ) | |
| — | |
| Other comprehensive loss | |
| (1 | ) | |
| (1 | ) | |
| (2 | ) | |
| — | |
| Comprehensive loss | |
$ | (3,948 | ) | |
$ | (13,247 | ) | |
$ | (10,219 | ) | |
$ | (26,499 | ) |
The accompanying notes are an integral part of
these unaudited condensed consolidated financial statements.
ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In thousands)
| | |
Six Months Ended
June 30, | |
| | |
2024 | | |
2023 | |
| Cash flows from operating activities | |
| | |
| |
| Net loss | |
$ | (10,217 | ) | |
$ | (26,499 | ) |
| Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
| Depreciation | |
| 76 | | |
| 56 | |
| Stock-based compensation | |
| 265 | | |
| — | |
| Change in fair value of convertible notes payable (related party) | |
| — | | |
| 18,143 | |
| Change in fair value of warrant liability (related party) | |
| — | | |
| 104 | |
| Change in fair value of publicly traded warrant liability | |
| 376 | | |
| — | |
| Change in fair value of forward purchase agreement warrant liability | |
| 18 | | |
| — | |
| Change in fair value of forward purchase agreement put option liability | |
| (103 | ) | |
| — | |
| Change in operating lease right-of-use assets (related party) | |
| (645 | ) | |
| 52 | |
| Change in inventory reserve | |
| 262 | | |
| (17 | ) |
| Changes in operating assets and liabilities: | |
| | | |
| | |
| Accounts receivable, net | |
| (104 | ) | |
| (14 | ) |
| Other receivables | |
| 148 | | |
| — | |
| Inventories | |
| (440 | ) | |
| 6 | |
| Prepaid expenses and other current assets | |
| 33 | | |
| (165 | ) |
| Accounts payable | |
| 35 | | |
| 1,357 | |
| Operating lease liabilities (related party) | |
| 734 | | |
| (75 | ) |
| Accrued expenses | |
| (1,171 | ) | |
| 139 | |
| Product warranty liability | |
| (21 | ) | |
| (132 | ) |
| Net cash used in operating activities | |
$ | (10,754 | ) | |
$ | (7,045 | ) |
| | |
| | | |
| | |
| Cash flows from investing activities | |
| | | |
| | |
| Purchases of property and equipment | |
| (357 | ) | |
| (70 | ) |
| Deposit on equipment not yet placed in service | |
| (542 | ) | |
| — | |
| Net cash used in investing activities | |
$ | (899 | ) | |
$ | (70 | ) |
| | |
| | | |
| | |
| Cash flows from financing activities | |
| | | |
| | |
| Proceeds from the issuance of convertible notes payable (related party) | |
| — | | |
| 7,000 | |
| Proceeds from the issuance of term loan (related party) | |
| 7,500 | | |
| — | |
| Proceeds from the sale of common stock associated with the forward purchase agreement, net of transaction costs | |
| 1,683 | | |
| — | |
| Net cash provided by financing activities | |
$ | 9,183 | | |
$ | 7,000 | |
| | |
| | | |
| | |
| Effect of exchange rate changes on cash | |
| (2 | ) | |
| — | |
| Net decrease in cash | |
| (2,472 | ) | |
| (115 | ) |
| Cash, beginning of period | |
| 4,218 | | |
| 183 | |
| Cash, end of period | |
$ | 1,746 | | |
$ | 68 | |
| | |
| | | |
| | |
| Supplemental disclosures of cash flow information | |
| | | |
| | |
| Cash paid for interest | |
$ | — | | |
$ | — | |
| Cash paid for income taxes | |
$ | — | | |
$ | — | |
| | |
| | | |
| | |
| Non-cash investing and financing activities | |
| | | |
| | |
| Deemed capital contribution from related party | |
$ | — | | |
$ | 2,988 | |
| Dividends on Series A Preferred Shares | |
$ | 2,730 | | |
$ | — | |
| Warrants issued with term note | |
$ | 376 | | |
$ | — | |
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
8
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