Conference call begins at 2:00 p.m. Pacific time today
PLEASANTON, Calif., Nov. 14,
2022 /PRNewswire/ -- Today, Movano
Inc. (NASDAQ:MOVE) dba Movano Health, a purpose-driven
healthcare solutions company at the intersection of medical and
consumer devices, reported financial results for the three months
ending September 30, 2022 and
provided a business update.
Highlights from the third quarter and recent weeks include the
following:
- Movano Health continues to expect to test the wearability and
functionality of its smart device in beta programs with multiple
strategic partners beginning in Q4 2022. In addition to conducting
a beta program with Stanford
University's Applied Sports Science department, Movano
Health named Novant Health, an integrated system of medical centers
that reported over $7 billion in
revenue in 2021, as its second beta partner. With more than 1,800
physicians providing care through close to six million annual
patient visits at nearly 800 locations across North Carolina, South Carolina and Georgia, Novant Health is seeking novel
technology, like Movano Health's solutions, that can provide
doctors greater visibility into patients' day-to-day health
metrics. The beta program will involve Novant Health's internal
teams as they evaluate the technology for its possible use cases
for patients and is expected to kick off in the near term.
- The Company is also preparing for two additional beta programs
– one with a major global pharmaceutical company and the other with
a leading patient-focused medical device company. Movano Health
continues to believe that leading pharmaceutical and medical device
enterprises are seeking to participate in the Company's beta
programs as a result of Movano Health's commitment to deploying
medical-grade data in a consumer wearable device, which has the
potential to help these enterprises improve remote care, as well as
provide critical clinical trial and post-market surveillance health
data.
- Movano Health has its sights set on its first FDA submission
for its heart rate and blood oxygen saturation (SpO2)
data. Following a successful pilot hypoxia study in July 2022, which compared the accuracy of Movano
Health's heart rate and SpO2 data to reference devices,
Movano Health completed a pivotal hypoxia study in October 2022. During the pilot study, Movano
Health's solution achieved a margin of error well below the FDA's
4% requirement for SpO2, and the ring also estimated
heart rate with accuracy commensurate with the FDA's standards.
Based on the positive results from the first study, Movano Health
is cautiously optimistic that the pivotal hypoxia study will
deliver similar results and the Company plans to provide more
information once the study data is reported by the clinical center
later this year or in early 2023. Assuming the results of the
pivotal study are in line with the industry standard used by the
FDA for evaluating SpO2 devices, Movano Health would
plan to file for FDA clearance on these metrics in early 2023.
- In January 2023, Movano Health
plans to announce the launch of its new brand and unveil more
details about its first commercial product at CES in Las Vegas. The Company is preparing for this
important milestone with the assistance of a best-in-class brand
marketing agency, research partner and mobile app developer.
Alongside these partners, Movano Health has interviewed over 1000
women, and uncovered key insights that are helping the Company
develop an engaging and differentiated user experience for women of
all ages. The Company continues to expect the launch of its first
commercial product in the first half of 2023.
- Movano Health is planning to commence blood pressure and
glucose studies before year-end 2022. The studies will be the first
to incorporate its proprietary single chip solution, the smallest
ever custom IC for cuffless blood pressure and non-invasive glucose
monitoring, which the Company recently integrated into a sleek
wrist-worn prototype system. Following the studies, the team
expects to use the data to further optimize its algorithms. The
Company also plans to initiate formal sleep studies before year-end
2022 to improve algorithms for sleep detection and assessment.
"We are on the verge of launching our first product, and our
work over the last quarter has been laser-focused on setting the
stage for a successful commercialization effort. After several
years of research, we're confident that we're developing the right
product at the right time," said John
Mastrototaro, PhD, CEO of Movano Health. "Data from the
American Heart Association and The Centers for Medicare &
Medicaid Services has brought to light some pretty harsh realities.
As of 2020, nearly 40% of Americans are living with a chronic
illness, and in the same year the U.S. spent almost 20% of its
total GDP on healthcare. There's an urgent need for solutions that
helps people better prevent or manage illnesses. Movano Health
is committed to developing wearable solutions that go beyond the
status quo by providing medical-grade data and relevant insights
around key biometrics that empower people to take ownership of
their health."
Third Quarter 2022 Financial Results
- Movano Health reported a net loss attributable to common
stockholders of $8.6 million, or a
loss of $(0.26) per basic and diluted
share, in the third quarter of 2022, compared with a net loss
attributable to common stockholders of $5.2
million, or a loss of $(0.16)
per basic and diluted share, in the third quarter of 2021.
- The Company reported an operating loss of $8.7 million in the third quarter of 2022
compared to an operating loss of $5.2
million in the third 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 third quarter of 2022 or the
third quarter of 2021.
- The Company had $16.8 million in
cash, cash equivalents and short-term investments as of
September 30, 2022, compared to
$33.6 million in cash, cash
equivalents and short-term investments, as of December 31, 2021. During the quarter, the
Company issued 674,191 shares of common stock at an average price
of $2.94 per share, via its
$50 million at-the-market (ATM)
issuance facility, resulting in $1.9
million of net proceeds.
- The total number of shares outstanding was 33,492,251 as of
September 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. PST (5:00 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, visit
www.movanohealth.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,
except share and per share data)
|
(Unaudited)
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2022
|
|
|
2021
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
15,945
|
|
|
$
|
17,675
|
|
Short-term
investments
|
|
|
822
|
|
|
|
15,921
|
|
Payroll tax credit, current
portion
|
|
|
379
|
|
|
|
166
|
|
Prepaid expenses and other
current assets
|
|
|
942
|
|
|
|
1,296
|
|
Total current assets
|
|
|
18,088
|
|
|
|
35,058
|
|
Property and equipment,
net
|
|
|
460
|
|
|
|
529
|
|
Payroll tax credit,
noncurrent portion
|
|
|
417
|
|
|
|
630
|
|
Other assets
|
|
|
488
|
|
|
|
48
|
|
Total assets
|
|
$
|
19,453
|
|
|
$
|
36,265
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
621
|
|
|
$
|
311
|
|
Other current
liabilities
|
|
|
3,746
|
|
|
|
2,907
|
|
Total current liabilities
|
|
|
4,367
|
|
|
|
3,218
|
|
Noncurrent
liabilities:
|
|
|
|
|
|
|
|
|
Early exercised stock option
liability
|
|
|
171
|
|
|
|
281
|
|
Other noncurrent
liabilities
|
|
|
258
|
|
|
|
36
|
|
Total noncurrent liabilities
|
|
|
429
|
|
|
|
317
|
|
Total liabilities
|
|
|
4,796
|
|
|
|
3,535
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value, 5,000,000 and no shares
authorized at
September 30,
2022 and December 31, 2021; no shares issued and
outstanding
at September 30, 2022 and December 31,
2021
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value, 75,000,000 shares authorized
at September
30, 2022 and
December 31, 2021; 33,492,251 and 32,772,060 shares
issued
and outstanding at September 30,
2022 and December 31, 2021, respectively
|
|
|
3
|
|
|
|
3
|
|
Additional paid-in capital
|
|
|
101,829
|
|
|
|
97,506
|
|
Accumulated other comprehensive loss
|
|
|
(5)
|
|
|
|
(11)
|
|
Accumulated deficit
|
|
|
(87,170)
|
|
|
|
(64,768)
|
|
Total stockholders' equity
|
|
|
14,657
|
|
|
|
32,730
|
|
Total liabilities,
redeemable convertible preferred stock, and stockholders'
equity
|
|
$
|
19,453
|
|
|
$
|
36,265
|
|
Movano Inc.
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
(in thousands,
except share and per share data)
|
(Unaudited)
|
|
|
|
Three Months
Ended
September 30,
|
|
|
Nine Months
Ended
September 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
5,146
|
|
|
$
|
3,803
|
|
|
$
|
13,849
|
|
|
$
|
8,928
|
|
General and administrative
|
|
|
3,511
|
|
|
|
1,376
|
|
|
|
8,592
|
|
|
|
4,563
|
|
Total operating expenses
|
|
|
8,657
|
|
|
|
5,179
|
|
|
|
22,441
|
|
|
|
13,491
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(8,657)
|
|
|
|
(5,179)
|
|
|
|
(22,441)
|
|
|
|
(13,491)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
55
|
|
|
|
6
|
|
|
|
39
|
|
|
|
15
|
|
Other income (expense), net
|
|
|
55
|
|
|
|
6
|
|
|
|
39
|
|
|
|
(1,977)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(8,602)
|
|
|
|
(5,173)
|
|
|
|
(22,402)
|
|
|
|
(15,468)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion and dividends
on redeemable convertible
preferred stock
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(2,489)
|
|
Net loss attributable
to common stockholders
|
|
$
|
(8,602)
|
|
|
$
|
(5,173)
|
|
|
$
|
(22,402)
|
|
|
$
|
(17,957)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,602)
|
|
|
$
|
(5,173)
|
|
|
$
|
(22,402)
|
|
|
$
|
(15,468)
|
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized loss on available-for-sale
securities
|
|
|
7
|
|
|
|
(2)
|
|
|
|
(3)
|
|
|
|
(3)
|
|
Total comprehensive
loss
|
|
$
|
(8,595)
|
|
|
$
|
(5,175)
|
|
|
$
|
(22,405)
|
|
|
$
|
(15,471)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders,
basic and diluted
|
|
$
|
(0.26)
|
|
|
$
|
(0.16)
|
|
|
$
|
(0.68)
|
|
|
$
|
(0.74)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
used in computing net loss per
share attributable to common stockholders,
basic and
diluted
|
|
|
32,949,649
|
|
|
|
32,268,890
|
|
|
|
32,829,940
|
|
|
|
24,200,475
|
|
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