Conference call begins at 9:00 a.m. Pacific time today
PLEASANTON, Calif., May 15, 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 March 31, 2023 and provided a business
update.
Key highlights from the first quarter and recent weeks
include:
- The Company announced publicly for the first time that it plans
to make the Evie Ring available for purchase in September 2023 for $269 with no subscription.
- Movano Health's regulatory team continues to make good progress
on its 510(k) submission for the Evie Ring's heart rate and blood
oxygen saturation (SpO2) data and plans to submit the
required documentation to the FDA in June 2023. The Company
is prepared to launch the Evie Ring as a wellness device and
then transition to a medical device later on if it has not received
a decision from the FDA by its planned launch date.
- In the four months since announcing the Evie Ring at CES in
January 2023, the Company has used a
combination of organic press and a strategic multi-channel paid and
organic social campaign to attract nearly 500,000 website visits
and more than 80,000 people have signed up to receive updates about
the Evie Ring. The impressive lead list combined with a strong
engagement rate on social media is a very positive sign for
conversion potential.
- Movano Health completed its first set of beta programs with
four partners, providing the Company with valuable feedback that is
being implemented to enhance the Evie Ring user experience.
- The Company is preparing to commence a second round of beta
programs by early July 2023 with a
new group of partners, including a global athletic apparel company
and two additional leading global medical device companies.
- As of tomorrow, the Company will have completed a three-week
blood pressure clinical trial, which included more than 50 subjects
and incorporated for the first time the Company's proprietary
radio-frequency (RF) single-chip solution. Movano Health expects to
analyze the results of the blood pressure clinical study through
the remainder of the second quarter and plans to conduct a
glucose clinical trial using the same RF enabled technology in the
near future.
"It has only been 18 months since we made the strategic decision
to commercialize a smart ring designed for women that qualifies for
FDA clearance. To go from ideation to a well-designed and
medical-grade wearable solution at such a rapid pace has been no
small feat," said John Mastrototaro,
CEO of Movano Health. "We're working through the final stages of
development before the planned commercial launch in September, and
we're excited to share the comprehensive and
differentiated solution with the world. We carefully
considered the right time for a commercial launch and believe
September gives us time to ensure we're putting out a high quality,
well-tested product while also balancing speed to market and
seasonality. Launching Evie will be a massive step in building the
foundation of our platform to provide people with the essential
data they need to understand the full picture of their health."
Movano Health details more information on the key highlights
from the first quarter of 2023 and recent weeks below:
Today, the Company announced that it plans to make the Evie Ring
available for purchase in September of this year for a flat fee of
$269 with no subscription. Movano
Health believes this launch timing and highly competitive and
attractive price point will set the Company up for success once the
device is ready for sale.
The Company is making good progress on its first 510(k)
submission to the FDA for heart rate and SpO2 data and
expects to make the submission in June 2023. In its Q4 2022
pivotal hypoxia study, the Evie Ring's heart rate and
SpO2 accuracy measurements were in line with the FDA's
requirements. Recently the Company completed a more comprehensive
heart rate evaluation on the bench per FDA guidelines to evaluate
the system in measuring heart rates from 40 to 240 beats per
minute. The results demonstrated excellent accuracy with errors of
less than 1 beat per minute. The September timing of the Evie
Ring launch may or may not sync with an FDA clearance. Regardless,
Movano Health is prepared to launch the Evie Ring as a wellness
device and then transition to a medical device upon receiving
clearance.
Interest in the Evie Ring has far exceeded the Company's
expectations. Announcing Evie at The Consumer Electronics Show in
January 2023 ignited strong interest,
and now Movano Health is building upon that earned awareness with a
strategic multi-channel paid and organic social campaign. In the
four months since the Evie Ring was announced, close to half a
million people have visited EvieRing.com and over 80,000 people
have signed up for the Evie newsletter. This demand signals
potential for a strong conversion rate once the device is ready for
sale. To bolster the upcoming launch of the Evie Ring and continue
to grow its follower base, Movano Health plans to invest in
influencer partnerships, celebrity endorsements, gifting, ad
campaigns and content creation and is building a panel of expert
medical advisors to lend their expertise on future product
features.
The Company completed its first set of Evie Ring beta programs
with four partners including Novant Health, Stanford University, a major global pharmaceutical
company and a leading patient-focused medical device company. The
beta programs have been a critical exercise in readying the Evie
Ring for commercialization.
Movano Health is incorporating the learnings from the first beta
into a second round of beta programs, which are set to commence by
early July 2023 and will include a
global athletic apparel company and two additional leading global
medical device companies.
In addition to preparing for the commercialization of the Evie
Ring, Movano Health is also advancing its proprietary and patented
System-on-a-Chip, which uses radio frequency technology to estimate
blood pressure without a cuff and blood glucose non-invasively.
Over the past three weeks, ending tomorrow, Movano Health will have
completed its first blood pressure clinical trial using the single
chip solution on more than 50 volunteers at the Movano Health
Clinical Lab. Analysis of the results will take place over the next
few weeks, and the Company expects the quality of the data signals
to be a meaningful improvement over previous prototypes, allowing
for further refinement of blood pressure algorithms. Movano Health
is planning to use the same single chip prototype in a glucose
clinical trial in late spring or early summer.
First Quarter 2023 Financial Results and Recent Capital
Markets Activity
- Movano Health reported a net loss of $7.1 million and a loss of $(0.19) per basic and diluted share, in the first
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 first
quarter of 2022.
- The Company reported an operating loss of $7.2 million in the first quarter of 2023
compared to an operating loss of $6.9
million in the first quarter of 2022.
- 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 first quarter of 2023 or the
first quarter of 2022.
- The Company had $14.3 million in
cash and cash equivalents as of March 31,
2023, compared to $10.8
million in cash and cash equivalents as of December 31, 2022.
- During the first quarter of 2023, Movano Health issued 7.7
million shares of common stock, primarily through an underwritten
public offering of 5.3 million shares of its common stock and
warrants to purchase up to 2.7 million shares of common stock
(resulting in gross proceeds to the Company of $7.5 million), and issued 2.1 million shares of
common stock via the Company's $50
million at-the-market (ATM) issuance facility (totaling
$2.8 million in net proceeds).
- The total number of shares outstanding was 41,377,867 as of
March 31, 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 9:00 a.m.
PDT (12:00 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.
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, is expected be
available for purchase in September
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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
2023
|
|
2022
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
14,269
|
|
$
10,759
|
Payroll tax credit,
current portion
|
|
289
|
|
379
|
Prepaid expenses and
other current assets
|
|
669
|
|
508
|
Total current
assets
|
|
15,227
|
|
11,646
|
Property and equipment,
net
|
|
418
|
|
443
|
Payroll tax credit,
noncurrent portion
|
|
667
|
|
667
|
Other assets
|
|
442
|
|
487
|
Total assets
|
|
$
16,754
|
|
$
13,243
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
540
|
|
$
557
|
Other current
liabilities
|
|
4,800
|
|
4,421
|
Total current
liabilities
|
|
5,340
|
|
4,978
|
Noncurrent
liabilities:
|
|
|
|
|
Early exercised stock
option liability
|
|
102
|
|
136
|
Other noncurrent
liabilities
|
|
168
|
|
214
|
Total noncurrent
liabilities
|
|
270
|
|
350
|
Total
liabilities
|
|
5,610
|
|
5,328
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common stock
|
|
4
|
|
3
|
Additional paid-in
capital
|
|
113,333
|
|
103,009
|
Accumulated
deficit
|
|
(102,193)
|
|
(95,097)
|
Total stockholders'
equity
|
|
11,144
|
|
7,915
|
Total liabilities and
stockholders' equity
|
|
$
16,754
|
|
$
13,243
|
Movano
Inc.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
|
(In thousands,
except share and per share data)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
2023
|
|
2022
|
OPERATING
EXPENSES:
|
|
|
|
|
Research and
development
|
|
$
3,894
|
|
$
4,591
|
Sales, general and
administrative
|
|
3,309
|
|
2,347
|
Total operating
expenses
|
|
7,203
|
|
6,938
|
Loss from
operations
|
|
(7,203)
|
|
(6,938)
|
|
|
|
|
|
Other income (expense),
net:
|
|
|
|
|
Interest and other
income, net
|
|
107
|
|
6
|
Other income (expense), net
|
|
107
|
|
6
|
|
|
|
|
|
Net loss
|
|
$
(7,096)
|
|
$
(6,932)
|
|
|
|
|
|
Net loss
|
|
$
(7,096)
|
|
$
(6,932)
|
Other comprehensive
loss:
|
|
|
|
|
Change in unrealized
loss on available-for-
sale securities
|
|
—
|
|
(19)
|
Total comprehensive
loss
|
|
$
(7,096)
|
|
$
(6,951)
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
(0.19)
|
|
$
(0.21)
|
|
|
|
|
|
Weighted average shares
used in computing net
loss per share, basic and diluted
|
|
37,541,070
|
|
32,744,004
|
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SOURCE Movano