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:
CoreIR516-222-2560investorrelations@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 EndedJune
30, |
|
|
Six Months EndedJune
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 EndedJune
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.
Envoy Medical (NASDAQ:COCH)
過去 株価チャート
から 7 2024 まで 8 2024
Envoy Medical (NASDAQ:COCH)
過去 株価チャート
から 8 2023 まで 8 2024