Conference call begins at 2:00 p.m. Pacific time today
PLEASANTON, Calif., Aug. 14,
2023 /PRNewswire/ -- Today, Movano Health
(Nasdaq: MOVE), a purpose-driven healthcare solutions company at
the intersection of medical and consumer devices and makers of the
Evie Ring, reported financial results for the three months ending
June 30, 2023 and provided a business
update.
Key highlights from the second quarter and recent weeks
include:
- Movano Health demonstrated significant progress with the
development of the Evie Ring, as well as fulfilling the
requirements of its FDA submission. The Company validated a
recently released, high-performance sensor that could improve the
efficacy of the ring and help position the Company's first
commercial product for success. Given expected implementation and
testing of the sensor and related solution enhancements, the
Company plans to launch Evie before Black Friday 2023.
- Movano Health successfully submitted its first 510(k)
application to the FDA for the Evie Ring's pulse oximeter, making
Evie one of the first consumer wearables to seek FDA clearance as a
medical device. The submission recently passed an initial review
for completeness and is now under full review by the FDA.
- The Evie Ring continues to generate strong consumer interest
and has reached a major milestone through strategic paid and
organic social media and email content. Year-to-date, more than
600,000 people have visited eviering.com and over 100,000
individuals signed up to receive updates about Evie's release,
demonstrating momentum for the upcoming launch.
- The Company is preparing for its second round of beta
programs ahead of the Evie Ring's commercial launch. Beta partners
include a global athletic apparel company, a major health insurer
and a leading remote patient monitoring company.
- Movano Health announced the formation of its Medical Advisory
Board. The initial panel is composed of healthcare industry subject
matter experts in women's health, mental health, and sleep, who
will serve as trusted advisors to the Evie team regarding the
development of its medical-grade smart ring for women and provide
insights to establish Evie as a highly credible health and wellness
resource.
- With an eye for future analytes, in May, the Company completed
an IRB-approved clinical study on over 50 volunteers in the Movano
Health Clinical Lab to test the efficacy of its proprietary, single
chip prototype in estimating blood pressure. Movano Health plans to
commence a study on an additional 50 volunteers in the near term
with a newly modified prototype.
"With the launch of the Evie Ring, we have an opportunity to
deliver a solution that ushers in a new era of women's health,"
said John Mastrototaro, CEO of
Movano Health. "Evie is not just another wearable device; it is a
medical-grade smart ring designed for women that we believe meets
the guidelines necessary for FDA clearance as a medical device,
which we are currently seeking. We're carving out a new category of
health-focused wearables by providing medical-grade accuracy,
personalized insights and a customized user experience."
Second Quarter 2023 Financial Results and Recent Capital
Markets Activity
- Movano Health reported a net loss of $7.3 million and a loss of $(0.17) per basic and diluted share, in the
second quarter of 2023, compared with a net loss of $6.9 million and a loss of $(0.21) per basic and diluted share, in the
second quarter of 2022.
- The Company reported an operating loss of $7.4 million in the second quarter of 2023
compared to an operating loss of $6.8
million in the second quarter of 2022.
- Movano Health is a development stage company and, as such, the
Company did not generate revenue in either the second quarter of
2023 or the second quarter of 2022.
- The Company had $14.5 million in
cash and cash equivalents as of June 30,
2023, compared to $10.8
million in cash and cash equivalents as of December 2022.
- During the second quarter of 2023, Movano Health raised
$9.2 million in gross proceeds
($8.1 million in net proceeds)
through an underwritten public offering of 9.2 million shares of
its common stock.
- The total number of shares outstanding was 50,646,661 as of
June 30, 2023.
Conference Call and Webcast
Management will host a
conference call and live audio webcast to discuss these results and
provide a business update today at 2:00 p.m.
PDT (5:00 p.m. EDT).
Attendees can access the live webcast here or on the
investors section of Movano Health's website at
https://ir.movano.com. The conference call can be accessed by
dialing 1-877-407-0989 (domestic) or +1- 201-389-0921
(international). Attendees can also use the Call Me link, in
which they will be dialed in to the conference call instantly on
the number provided with no hold time. An archived webcast will be
available on Movano Health's website approximately one hour after
the completion of the event and for two years thereafter.
About Movano Health
Founded in 2018, Movano Inc. (Nasdaq: MOVE) dba Movano Health is
developing a suite of purpose-driven healthcare solutions to bring
medical-grade, high-quality data to the forefront of consumer
health devices. Featuring modern form factors, Movano Health's
devices capture a comprehensive picture of a person's vital health
information and uniquely translate the data into personalized and
intelligent insights that empower consumers to live healthier and
more balanced lives. Movano Health's end-to-end solutions will soon
enable consumers and their healthcare professionals to utilize
daily medical-grade data as a tool to proactively monitor and
manage health outcomes. For more information on Movano
Health, visit https://movanohealth.com/.
Movano Health's Evie Ring is the first smart ring
specifically designed to address women's health
concerns. To stay up to date on Evie's
launch, visit
https://eviering.com/.
Forward Looking Statements
This press release contains forward-looking statements concerning
our expectations, anticipations, intentions, beliefs, or strategies
regarding the future. These forward-looking statements are based on
assumptions that we have made as of the date hereof and are subject
to known and unknown risks and uncertainties that could cause
actual results, conditions, and events to differ materially from
those anticipated. Therefore, you should not place undue reliance
on forward-looking statements. Examples of forward-looking
statements include, among others, statements we make regarding
anticipated FDA clearance for the Evie Ring, expected future
operating results; product development and features, product
releases, clinical trial, and regulatory initiatives; our
strategies, positioning and expectations for future events or
performance. Important factors that could cause actual results to
differ materially from those in the forward-looking statements are
set forth in our most recent Annual Report on Form 10-K and any
subsequent Quarterly Reports on Form 10-Q, and in our other reports
filed with the Securities and Exchange Commission, including under
the caption "Risk Factors." Any forward-looking statement in
this release speaks only as of the date of this release. We
undertake no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise.
Movano Inc.
|
CONDENSED CONSOLIDATED BALANCE
SHEETS
|
(In thousands)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
December 31,
|
|
|
2023
|
|
2022
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
14,472
|
|
$
10,759
|
Payroll tax credit,
current portion
|
|
271
|
|
379
|
Prepaid expenses and
other current assets
|
|
1,343
|
|
508
|
Total current
assets
|
|
16,086
|
|
11,646
|
Property and equipment,
net
|
|
404
|
|
443
|
Payroll tax credit,
noncurrent portion
|
|
667
|
|
667
|
Other assets
|
|
416
|
|
487
|
Total assets
|
|
$
17,573
|
|
$
13,243
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
1,522
|
|
$
557
|
Other current
liabilities
|
|
3,031
|
|
4,421
|
Total current
liabilities
|
|
4,553
|
|
4,978
|
Noncurrent
liabilities:
|
|
|
|
|
Early exercised stock
option liability
|
|
71
|
|
136
|
Other noncurrent
liabilities
|
|
121
|
|
214
|
Total noncurrent
liabilities
|
|
192
|
|
350
|
Total
liabilities
|
|
4,745
|
|
5,328
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common stock
|
|
5
|
|
3
|
Additional paid-in
capital
|
|
122,283
|
|
103,009
|
Accumulated
deficit
|
|
(109,460)
|
|
(95,097)
|
Total stockholders'
equity
|
|
12,828
|
|
7,915
|
Total liabilities and
stockholders' equity
|
|
$
17,573
|
|
$
13,243
|
Movano Inc.
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS
|
(In thousands, except share and per share
data)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
4,171
|
|
$
4,112
|
|
$
8,065
|
|
$
8,703
|
Sales, general and
administrative
|
|
3,213
|
|
2,734
|
|
6,522
|
|
5,081
|
Total operating
expenses
|
|
7,384
|
|
6,846
|
|
14,587
|
|
13,784
|
Loss from
operations
|
|
(7,384)
|
|
(6,846)
|
|
(14,587)
|
|
(13,784)
|
|
|
|
|
|
|
|
|
|
Other income (expense),
net:
|
|
|
|
|
|
|
|
|
Interest and other
income (expense), net
|
|
117
|
|
(22)
|
|
224
|
|
(16)
|
Other income (expense), net
|
|
117
|
|
(22)
|
|
224
|
|
(16)
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(7,267)
|
|
$
(6,868)
|
|
$
(14,363)
|
|
$
(13,800)
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
(7,267)
|
|
$
(6,868)
|
|
$
(14,363)
|
|
$
(13,800)
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
Change in unrealized
loss on available-for-sale
securities
|
|
—
|
|
15
|
|
—
|
|
(4)
|
Total comprehensive
loss
|
|
$
(7,267)
|
|
$
(6,853)
|
|
$
(14,363)
|
|
$
(13,804)
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
(0.17)
|
|
$
(0.21)
|
|
$
(0.36)
|
|
$
(0.42)
|
|
|
|
|
|
|
|
|
|
Weighted average shares
used in computing net loss per
share, basic and diluted
|
|
43,056,785
|
|
32,793,907
|
|
40,314,164
|
|
32,769,093
|
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SOURCE Movano