Conference call begins at 2:00 p.m. Pacific time today
PLEASANTON, Calif., Aug. 15,
2022 /PRNewswire/ -- Today, Movano Inc.
(NASDAQ:MOVE), a purpose-driven healthcare solutions company at the
intersection of medtech and consumer devices, reported financial
results for the three months ending June 30,
2022 and provided a business update.
Highlights from the second quarter and recent weeks include the
following:
- Movano plans to conduct beta test programs with several
strategic partners utilizing the Movano Ring, the Company's first
commercial product designed to blend the best features of medical
and wellness devices to help women better understand the
correlation between how they feel and various aspects of their
health. The Company named its first beta partner as Stanford University's Applied Sports Science
department. Stanford is looking to test
wearable technology, like the Movano Ring, to drive innovation that
facilitates the ethical enhancement of athletic performance and
improve the quality of life of the Stanford athlete.
- Further, Movano is kicking off beta programs with several other
organizations including a major global pharmaceutical company, a
leading global diabetes-focused medical device company, and an
integrated regional health network. The beta test programs are
expected to commence in the fourth quarter of 2022, and the
development of these partnerships across the broader healthcare
landscape is an important milestone in building the foundation for
an enterprise solution.
- Movano expects the direct-to-consumer launch of the Movano Ring
to take place in the first half of 2023. To prepare for the broader
launch, the Company has hired a world class go-to-market (GOTM)
leadership team. Over the last several months, this team, along
with leading app development partners, has continued to build on
the foundational elements already in place, aiming to create a
unique and valuable user experience. Further, the Company has
secured leading marketing, branding, website development and
consumer research partners, to ensure the brand is engaging and
relevant to the target audience.
- After recently completing an initial hypoxia study with the
University of California San Francisco
(UCSF) and announcing high accuracy marks for its blood oxygen
saturation (SpO2) and heart rate data, the Company is
eyeing its first FDA submission. The recently completed pilot study
tested the accuracy of the Movano Ring on seven subjects during
mild, moderate and severe hypoxia and followed the same protocol
that is expected to be required by the FDA for the submission. In
comparing the overall accuracy of the Ring's data with that of the
reference devices, the Movano Ring achieved a 2% margin of error,
well below the FDA's 4% requirement for SpO2. In
addition, the Ring also estimated heart rate with accuracy
commensurate with the FDA's standards. This successful study
demonstrates the potential for wearables to properly track sleep
and heart health and detect potential illnesses, such as sleep
apnea, and is a major step toward the Company's goal of providing
medically-validated data to consumers and healthcare professionals.
Based on the positive results from this study, Movano plans to
conduct a larger pivotal study for the FDA submission later this
year.
- Movano plans to conduct additional blood pressure and glucose
clinical studies beginning in the third quarter of 2022, utilizing
its proprietary and patented system-on-a-chip (SoC), which is the
smallest ever custom mmWave integrated sensor designed specifically
for non-invasive glucose and cuffless blood pressure monitoring.
While the majority of current wearables on the market use
off-the-shelf optical sensors, Movano spent four years developing,
designing and shrinking its multi-chip architecture from four
integrated circuits into a single SoC in an effort to deliver a
higher level of accuracy, offer form factor flexibility and provide
its technology to consumers at a lower price point. Movano is
currently integrating the SoC into a new prototype system, which
will be closer in size and shape to its final product, and enable
the Company to conduct longer, more complex blood pressure and
glucose studies.
- Movano was recently granted two new patents centered around
Movano's SoC, marking a total of nine U.S. patents currently issued
to the Company. The two new patents protect the SoC's agile method
of understanding detailed features of waveforms that aid in
estimating blood pressure and other analytes.
"It's an exciting time for our emerging company as we're working
toward commercialization of the Movano Ring, a smart ring designed
for women. Our team has accomplished several significant milestones
over a short period of time, including the development of multiple
beta test programs in partnership with leaders in the healthcare
space and a highly encouraging hypoxia pilot study. In parallel, we
successfully completed testing of our proprietary and patented
system-on-a-chip, the smallest custom mmWave integrated sensor for
cuffless blood pressure and non-invasive glucose monitoring, and
are now integrating it into a prototype platform for clinical
evaluations," said Dr. John
Mastrototaro, CEO of Movano Inc. "We aim to move healthcare
technology in a direction that's more accessible, both in price and
in experience, arming consumers with medically validated data and
key insights they can trust, and packaging it into a solution that
looks great and provides real value, so it becomes a seamless part
of their everyday routine and helps them achieve a more well
balanced and healthier life."
Second Quarter 2022 Financial Results
- Movano reported a net loss attributable to common stockholders
of $6.9 million, or a loss of
$(0.21) per basic and diluted share,
in the second quarter of 2022, compared with a net loss
attributable to common stockholders of $4.7
million, or a loss of $(0.15)
per basic and diluted share, in the second quarter of 2021.
- The Company reported an operating loss of $6.8 million in the second quarter of 2022
compared to an operating loss of $5.0
million in the second quarter of 2021.
- Movano 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 second quarter of 2022 or the second
quarter of 2021.
- The Company had $21.3 million in
cash, cash equivalents and short-term investments as of
June 30, 2022, compared to
$33.6 million in cash, cash
equivalents and short-term investments, as of December 31, 2021.
- The total number of shares outstanding was 32,818,060 as of
June 30, 2022.
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'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's website
approximately one hour after the completion of the event and for
two years thereafter.
To learn more about Movano Inc., please visit www.movano.com
About Movano
Founded in 2018, Movano Inc.
(NASDAQ:MOVE) 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's wearables 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's end-to-end
solutions will soon enable a world where consumers, caretakers and
healthcare professionals can utilize daily health data as a tool to
proactively monitor and manage their health. For more information,
visit www.movano.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 efforts and
product releases; clinical trial and regulatory initiatives;
commercial partner activities; as well as 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, except share and per share
data) (Unaudited)
|
|
|
June
30,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
17,089
|
|
|
$
|
17,675
|
|
Short-term
investments
|
|
|
4,214
|
|
|
|
15,921
|
|
Payroll tax
credit, current portion
|
|
|
379
|
|
|
|
166
|
|
Prepaid expenses
and other current assets
|
|
|
1,289
|
|
|
|
1,296
|
|
Total current
assets
|
|
|
22,971
|
|
|
|
35,058
|
|
Property and equipment,
net
|
|
|
474
|
|
|
|
529
|
|
Payroll tax credit,
noncurrent portion
|
|
|
417
|
|
|
|
630
|
|
Other assets
|
|
|
530
|
|
|
|
48
|
|
Total assets
|
|
$
|
24,392
|
|
|
$
|
36,265
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
753
|
|
|
$
|
311
|
|
Other current liabilities
|
|
|
2,635
|
|
|
|
2,907
|
|
Total current
liabilities
|
|
|
3,388
|
|
|
|
3,218
|
|
Noncurrent
liabilities:
|
|
|
|
|
|
|
|
|
Early exercised stock option liability
|
|
|
205
|
|
|
|
281
|
|
Other noncurrent liabilities
|
|
|
302
|
|
|
|
36
|
|
Total noncurrent
liabilities
|
|
|
507
|
|
|
|
317
|
|
Total
liabilities
|
|
|
3,895
|
|
|
|
3,535
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies (Note 12)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value, 5,000,000 shares
authorized at June 30, 2022
and December 31,
2021; no shares issued and outstanding at June 30, 2022
and December 31,
2021
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.0001 par value, 75,000,000 shares authorized
at June 30, 2022
and December 31,
2021; 32,818,060 and 32,772,060 shares issued and
outstanding at
June 30, 2022 and December 31, 2021, respectively
|
|
|
3
|
|
|
|
3
|
|
Additional paid-in capital
|
|
|
99,077
|
|
|
|
97,506
|
|
Accumulated other comprehensive loss
|
|
|
(15)
|
|
|
|
(11)
|
|
Accumulated deficit
|
|
|
(78,568)
|
|
|
|
(64,768)
|
|
Total stockholders' equity
|
|
|
20,497
|
|
|
|
32,730
|
|
Total liabilities and
stockholders' equity
|
|
$
|
24,392
|
|
|
$
|
36,265
|
|
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,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
$
|
4,112
|
|
|
$
|
3,183
|
|
|
$
|
8,703
|
|
|
$
|
5,125
|
|
General
and administrative
|
|
|
2,734
|
|
|
|
1,863
|
|
|
|
5,081
|
|
|
|
3,187
|
|
Total operating
expenses
|
|
|
6,846
|
|
|
|
5,046
|
|
|
|
13,784
|
|
|
|
8,312
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(6,846)
|
|
|
|
(5,046)
|
|
|
|
(13,784)
|
|
|
|
(8,312)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
—
|
|
|
|
351
|
|
Interest and other income (expense), net
|
|
|
(22)
|
|
|
|
8
|
|
|
|
(16)
|
|
|
|
9
|
|
Other income (expense),
net
|
|
|
(22)
|
|
|
|
359
|
|
|
|
(16)
|
|
|
|
(1,983)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(6,868)
|
|
|
|
(4,687)
|
|
|
|
(13,800)
|
|
|
|
(10,295)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion and dividends
on redeemable convertible preferred stock
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(2,489)
|
|
Net loss attributable
to common stockholders
|
|
$
|
(6,868)
|
|
|
$
|
(4,687)
|
|
|
$
|
(13,800)
|
|
|
$
|
(12,784)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(6,868)
|
|
|
$
|
(4,687)
|
|
|
$
|
(13,800)
|
|
|
$
|
(10,295)
|
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized gain (loss) on available-for-sale
securities
|
|
|
15
|
|
|
|
(1)
|
|
|
|
(4)
|
|
|
|
(1)
|
|
Total comprehensive
loss
|
|
$
|
(6,853)
|
|
|
$
|
(4,688)
|
|
|
$
|
(13,804)
|
|
|
$
|
(10,296)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
|
$
|
(0.21)
|
|
|
$
|
(0.15)
|
|
|
$
|
(0.42)
|
|
|
$
|
(0.64)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
used in computing net loss per share attributable to common
stockholders, basic and diluted
|
|
|
32,793,907
|
|
|
|
32,017,335
|
|
|
|
32,769,093
|
|
|
|
20,099,402
|
|
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