Conference call begins at 9:00 a.m. Pacific time today
PLEASANTON, Calif., March 20,
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 and year
ending December 31, 2022 and provided
a business update.
Key highlights from the fourth quarter and recent weeks
include:
- Movano Health continues to progress toward the summer 2023
launch of its first commercial product, the Evie Ring.
- Given the strong demand in its initial beta, the Company
announced a second beta program with a new slate of partners, among
which are a global athletic apparel company and two additional
leading global medical device companies.
- Movano Health plans to file its first 510(k) submission for FDA
clearance of the Evie Ring's heart rate and SpO2 data
this spring following a successful hypoxia pivotal trial in Q4 of
2022.
- The Company plans to commence the first blood pressure and
glucose clinical studies using its proprietary single chip
technology imminently.
- Movano Health has recently been issued nine new U.S. patents,
including multiple foundational patents that protect the Company's
unique method, system and algorithms used for measuring blood
pressure and glucose non-invasively and without a cuff.
"It's an exciting time at Movano Health as we're about to launch
our first product, the Evie Ring, transitioning us from a pre- to
revenue-generating company and opening the door to a massive
opportunity for product partnerships," said John Mastrototaro, CEO of Movano Health. "With
the Evie Ring and our future pipeline of devices, we're forging new
territory by developing products positioned at the intersection of
medtech and consumer devices, a market opportunity we believe is
worth $50 billion in the United States alone."
Movano Health details more information on the key highlights
from the fourth quarter and recent weeks below:
Movano Health continues to progress toward the summer 2023
launch of its first commercial product, the Evie Ring. After
unveiling the ring at the Consumer Electronics Show in early 2023,
the Evie Ring won a total of 11 Best of CES awards from premium
publications including CNN, USA
Today, Wired and Digital Trends, which highlighted the Company's
focus on women, the open design of the ring, the portability of the
charger and the ring's competitive price point with no monthly
subscription. Building off the strong momentum from CES, Movano
Health began paid and organic campaigns and is seeing impressive
results which show both promise and demand for the launch of a
female-first wearable.
In order to gain additional valuable user feedback,
the Company has commenced its first round of beta programs
with four initial partners including Novant Health, Stanford University, a major global pharmaceutical
company and a leading patient-focused medical device company. Given
the strong demand in its initial beta, the Company announced a
second beta program with a new slate of partners, among which are a
global athletic apparel company and two additional leading global
medical device companies. Movano Health expects its beta
programs to highlight the opportunity for integrated product
partnerships with the Evie Ring to monitor a variety of specific
medical conditions, improve patient outcomes and act as a driver of
innovation and growth.
Movano Health plans to file its first 510(k) submission for
FDA clearance of the Evie Ring's heart rate and
SpO2 data this spring following a successful
hypoxia pivotal trial in Q4 of 2022. During the Q4 hypoxia
study, comparing the overall accuracy of the ring's data with data
from the study's reference devices, the Evie Ring resulted in an
approximate 2% margin of error, well below the FDA consensus
standard of 3.5% for SpO2.The Evie Ring's heart rate
monitor had root mean square error of approximately 2 beats per
minute, which is also in line with the FDA's requirements.
The Company successfully implemented its proprietary
System-on-a-Chip, which is the smallest ever RF-enabled integrated
circuit designed specifically for blood pressure or glucose
monitoring, into a new, battery powered wrist worn device that is
smaller than most wrist worn wearables today. It plans to
commence the first blood pressure and glucose clinical studies
using its proprietary single chip technology imminently.
Movano Health has recently been issued nine new U.S. patents,
including multiple foundational patents that protect the Company's
unique method, system and algorithms used for measuring blood
pressure and glucose non-invasively and without a cuff. The new
patents validate the Company's cutting-edge approach to RF enabled
glucose and blood pressure monitoring and extend its growing
intellectual property portfolio to 21 patents issued in
the United States, 1 patent issued
in China and 36 pending
worldwide.
Fourth Quarter 2022 Financial Results and Recent Capital
Markets Activity
- Movano Health reported a net loss attributable to common
stockholders of $7.9 million, or a
loss of $(0.24) per basic and diluted
share, in the fourth quarter of 2022, compared with a net loss
attributable to common stockholders of $6.3
million, or a loss of $(0.19)
per basic and diluted share, in the fourth quarter of 2021. For the
year ended December 31, 2022, net
loss attributable to common stockholders was $30.3 million or $(0.92) per share, compared with a net loss
attributable to common stockholders of $24.3
million or $(0.92) per share
for the year ended December 31,
2021.
- The Company reported an operating loss of $8.0 million in the fourth quarter of 2022
compared to an operating loss of $6.3
million in the fourth quarter of 2021.
- Movano Health is a development stage company and the majority
of its business activities to date and planned future activities
will be devoted to research and development. As such, the Company
did not generate revenue in either the fourth quarter of 2022 or
the fourth quarter of 2021.
- The Company had $10.8 million in
cash and cash equivalents as of December 31,
2022, compared to $33.6
million in cash, cash equivalents and short-term
investments, as of December 31, 2021.
During the fourth quarter or 2022, the Company issued 167,209
shares of common stock, primarily through the issuance of 137,209
shares via its $50 million
at-the-market (ATM) issuance facility at an average price of
$2.33 per share, resulting in
$0.3 million of net
proceeds.
- The total number of shares outstanding was 33,659,460 as of
December 31, 2022.
- In the first quarter of 2023, Movano Health completed a
$7.5 million underwritten public
offering of 5,340,600 shares of its common stock and warrants to
purchase up to 2,670,300 shares of common stock, including the full
exercise of the underwriter's overallotment option. The warrants
were sold at the rate of one warrant for every two shares of common
stock and will be exercisable at a price per share of $1.57. The public offering price, before the
underwriters' discount and commissions, for each share of common
stock and accompanying warrant was $1.40. The Company intends to use the net
proceeds from the offering for general corporate purposes, which
may include funding product development and commercialization
activities.
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
9:00 a.m. PST (12:00 p.m. EST).
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.
To learn more about Movano Inc., please visit
https://movanohealth.com/
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, caretakers, and healthcare professionals to
utilize daily medical-grade data as a tool to proactively monitor
and manage their health. For more information on Movano
Health, visit https://movanohealth.com/.
Movano Health's Evie Ring, which is specifically designed
to address women's health concerns, will be available for
purchase in summer 2023. 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 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)
|
|
|
|
December
31,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
10,759
|
|
|
$
|
17,675
|
|
Short-term investments
|
|
|
—
|
|
|
|
15,921
|
|
Payroll tax credit, current portion
|
|
|
379
|
|
|
|
166
|
|
Prepaid expenses and other current assets
|
|
|
508
|
|
|
|
1,296
|
|
Total current
assets
|
|
|
11,646
|
|
|
|
35,058
|
|
Property and equipment,
net
|
|
|
443
|
|
|
|
529
|
|
Payroll tax credit,
noncurrent portion
|
|
|
667
|
|
|
|
630
|
|
Other assets
|
|
|
487
|
|
|
|
48
|
|
Total assets
|
|
$
|
13,243
|
|
|
$
|
36,265
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
557
|
|
|
$
|
311
|
|
Other current liabilities
|
|
|
4,421
|
|
|
|
2,907
|
|
Total current
liabilities
|
|
|
4,978
|
|
|
|
3,218
|
|
Noncurrent
liabilities:
|
|
|
|
|
|
|
|
|
Early exercised stock option liability
|
|
|
136
|
|
|
|
281
|
|
Other noncurrent liabilities
|
|
|
214
|
|
|
|
36
|
|
Total noncurrent
liabilities
|
|
|
350
|
|
|
|
317
|
|
Total
liabilities
|
|
|
5,328
|
|
|
|
3,535
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
3
|
|
|
|
3
|
|
Additional paid-in capital
|
|
|
103,009
|
|
|
|
97,506
|
|
Accumulated other comprehensive loss
|
|
|
—
|
|
|
|
(11)
|
|
Accumulated deficit
|
|
|
(95,057)
|
|
|
|
(64,768)
|
|
Total stockholders' equity
|
|
|
7,915
|
|
|
|
32,730
|
|
Total liabilities and
stockholders' equity
|
|
$
|
13,243
|
|
|
$
|
36,265
|
|
Movano Inc.
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands,
except share and per share data)
(Unaudited)
|
|
|
|
Three Months
Ended
December 31,
|
|
|
Year Ended
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
5,145
|
|
|
$
|
4,499
|
|
|
$
|
18,994
|
|
|
$
|
13,427
|
|
Sales, general and administrative
|
|
|
2,876
|
|
|
|
1,813
|
|
|
|
11,468
|
|
|
|
6,376
|
|
Total operating
expenses
|
|
|
8,021
|
|
|
|
6,312
|
|
|
|
30,462
|
|
|
|
19,803
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(8,021)
|
|
|
|
(6,312)
|
|
|
|
(30,462)
|
|
|
|
(19,803)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense),
net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(883)
|
|
Change in fair value of warrant liability
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(1,581)
|
|
Change in fair value of derivative liability
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
121
|
|
Forgiveness of Paycheck Protection Program Loan
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
351
|
|
Interest and other income, net
|
|
|
94
|
|
|
|
7
|
|
|
|
133
|
|
|
|
22
|
|
Other income (expense),
net
|
|
|
94
|
|
|
|
7
|
|
|
|
133
|
|
|
|
(1,970)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(7,927)
|
|
|
|
(6,305)
|
|
|
|
(30,329)
|
|
|
|
(21,773)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion and dividends
on redeemable convertible
preferred stock
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(2,489)
|
|
Net loss attributable
to common stockholders
|
|
$
|
(7,927)
|
|
|
$
|
(6,305)
|
|
|
$
|
(30,329)
|
|
|
$
|
(24,262)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(7,927)
|
|
|
$
|
(6,305)
|
|
|
$
|
(30,329)
|
|
|
$
|
(21,773)
|
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized loss on available-for-sale
securities
|
|
|
3
|
|
|
|
(8)
|
|
|
|
—
|
|
|
|
(11)
|
|
Total comprehensive
loss
|
|
$
|
(7,924)
|
|
|
$
|
(6,313)
|
|
|
$
|
(30,329)
|
|
|
$
|
(21,784)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common
stockholders, basic and diluted
|
|
$
|
(0.24)
|
|
|
$
|
(0.19)
|
|
|
$
|
(0.92)
|
|
|
$
|
(0.92)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
used in computing net
loss per share attributable to
common
stockholders, basic and diluted
|
|
|
33,606,680
|
|
|
|
32,522,305
|
|
|
|
33,025,721
|
|
|
|
26,298,032
|
|
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SOURCE Movano