Highlights successful Evie Ring back-in-stock
execution
Updates status of EvieMED 510(k) application
review
Focuses on launch of EvieMED and securing B2B
opportunities
Conference Call at 2:00
PM PT/ 5:00 PM ET
Today
PLEASANTON, Calif., Nov. 14,
2024 /PRNewswire/ -- Movano Health (Nasdaq:
MOVE), a pioneer in health technology, reported third quarter 2024
results and provided a business update.
The Company continues to remain focused on three key business
initiatives.
- Successful execution of the Evie Ring direct-to-consumer
business (D2C) following the September
17th back-in-stock launch, bolstered by an
enhanced product experience and improved operations across
manufacturing, logistics and customer service.
- Securing FDA 510(k) clearance for the EvieMED Ring and pursuing
initial business-to-business (B2B) commercial agreements across the
healthcare sector.
- Advancing cuffless blood pressure and noninvasive glucose
monitoring clinical studies with Movano Health's proprietary and
patented System-on-a-Chip (SoC).
"We are pleased with our Evie Ring D2C performance and continue
to be laser focused on improving the consumer experience, including
the upcoming launch of our Android app, as we head into the holiday
period in order to maximize our sales potential," said John Mastrototaro, President and CEO of Movano
Health. "Additionally, we look forward to the successful completion
of the 510(k) application review process of the EvieMED Ring and
continue to focus on the game changing opportunities that we
believe EvieMED could unlock for our healthcare partners."
Recent Operating Highlights and Milestones
- On September 17, 2024, Movano
Health successfully launched a back-in-stock campaign for the Evie
Ring D2C business. On October 30,
2024, the Company also shared the official announcement of
its first brand partnership with content creator Heidi
D'Amelio.
- The Company continues to work collaboratively with the FDA and
remains in the final stage of its FDA 510(k) application review
process for the EvieMED Ring. The EvieMED Ring is designed to not
only provide medical device functionality with its pulse oximetry
feature, but also offer numerous wellness metrics related to sleep,
activity and logging of mood, energy and health symptoms. This
summer, Movano Health secured a positive resolution after
responding to initial FDA questions related to EvieMED's wellness
features and metrics. During the week of October 28, 2024, the Company submitted a
complete response package to additional clarifying questions
related to the medical aspects of EvieMED.
- Movano Health continues to make important progress on the B2B
front in anticipation of an expected 510(k) clearance, re-engaging
with a number of potential partners across the full spectrum of
healthcare use cases. For example, the Company has entered into the
agreement phase with a large healthcare company for a pilot program
in Q1 2025 using the EvieMED Ring as part of an overall metabolic
solution to address chronic disease.
- Movano Health tested its newly developed blood pressure wrist
wearable as part of a November
5th and 6th hypoxia clinical trial
that took place at the University of
California, San Francisco. The updated device features an
additional 12 mmWave antennas, which together with the Company's
custom RF chip, delivers enhanced data collection with less impact
of placement while also featuring a slimmer design, making it
easier and more comfortable to wear. In addition, the new wearable
monitors a host of other vital signs including pulse rate, blood
oxygen saturation (Sp02), respiration rate and ECG
waveforms.
Third Quarter 2024 and Recent Financial Highlights
- In Q3 2024, Movano Health shipped 339 Evie Rings.
- The Company reported an operating loss of $7.4 million in Q3 2024, compared to an operating
loss of $9.1 million in Q3 2023.
- Total cash and cash equivalents at September 30, 2024 were $11.3 million.
- On October 29, 2024, the Company
implemented a 1-for-15 reverse stock split of the issued shares of
its common stock. The reverse stock split was intended to increase
the bid price of the common stock to enable the Company to regain
compliance for continued listing on The Nasdaq Capital Market. On
November 12, 2024, the Company was
informed by Nasdaq that it had regained compliance with the minimum
bid price requirement.
Conference Call
Management will host a conference call and live audio webcast to
discuss these results and provide a business update today at
2:00 pm PT/5:00 pm ET.
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, maker of the Evie Ring
(www.eviering.com), is developing a suite of purpose-driven
healthcare solutions to bring medical-grade data to the forefront
of wearables. Featuring modern and flexible form factors, Movano
Health's devices offer an innovative approach to delivering trusted
data to both customers and enterprises, capturing a comprehensive
picture of an individual's health data and uniquely translating it
into personalized and intelligent insights.
Movano Health is developing its proprietary technologies and
wearable medical device solutions to enable the future use of data
as a tool to proactively monitor and manage health outcomes across
a number of patient populations that exist in healthcare. For more
information on Movano Health, visit https://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 plans with
respect to the commercial launches of the Evie Ring and EvieMED;
our expectations regarding potential commercial opportunities;
planned cost-cutting initiatives; anticipated FDA clearance
decisions with respect to our products; expected future operating
results; product development and features, product releases,
clinical trials 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)
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2024
|
|
|
2023
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
11,272
|
|
|
$
|
6,118
|
|
Payroll tax credit,
current portion
|
|
|
233
|
|
|
|
450
|
|
Vendor
deposits
|
|
|
9
|
|
|
|
399
|
|
Inventory
|
|
|
2,033
|
|
|
|
1,114
|
|
Prepaid expenses and
other current assets
|
|
|
467
|
|
|
|
442
|
|
Total current assets
|
|
|
14,014
|
|
|
|
8,523
|
|
Property and equipment,
net
|
|
|
237
|
|
|
|
342
|
|
Payroll tax credit,
noncurrent portion
|
|
|
55
|
|
|
|
169
|
|
Other assets
|
|
|
761
|
|
|
|
387
|
|
Total assets
|
|
$
|
15,067
|
|
|
$
|
9,421
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,896
|
|
|
$
|
3,118
|
|
Deferred
revenue
|
|
|
20
|
|
|
|
1,252
|
|
Other current
liabilities
|
|
|
2,317
|
|
|
|
1,529
|
|
Total current liabilities
|
|
|
4,233
|
|
|
|
5,899
|
|
Noncurrent
liabilities:
|
|
|
|
|
|
|
|
|
Early exercised stock
option liability
|
|
|
—
|
|
|
|
23
|
|
Other noncurrent
liabilities
|
|
|
583
|
|
|
|
50
|
|
Total noncurrent liabilities
|
|
|
583
|
|
|
|
73
|
|
Total liabilities
|
|
|
4,816
|
|
|
|
5,972
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
10
|
|
|
|
6
|
|
Additional paid-in
capital
|
|
|
153,732
|
|
|
|
127,823
|
|
Accumulated
deficit
|
|
|
(143,491)
|
|
|
|
(124,380)
|
|
Total stockholders'
equity
|
|
|
10,251
|
|
|
|
3,449
|
|
Total liabilities and stockholders' equity
|
|
$
|
15,067
|
|
|
$
|
9,421
|
|
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,
|
|
|
|
2024
|
|
|
2023
|
|
|
2024
|
|
|
2023
|
|
Revenue
|
|
$
|
50
|
|
|
$
|
—
|
|
|
$
|
902
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COSTS AND
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
revenue
|
|
|
845
|
|
|
|
—
|
|
|
|
2,440
|
|
|
|
—
|
|
Research and
development
|
|
|
3,404
|
|
|
|
5,636
|
|
|
|
9,198
|
|
|
|
13,701
|
|
Sales, general and
administrative
|
|
|
3,180
|
|
|
|
3,443
|
|
|
|
8,794
|
|
|
|
9,965
|
|
Total costs and
expenses
|
|
|
7,429
|
|
|
|
9,079
|
|
|
|
20,432
|
|
|
|
23,666
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(7,379)
|
|
|
|
(9,079)
|
|
|
|
(19,530)
|
|
|
|
(23,666)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense),
net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income, net
|
|
|
178
|
|
|
|
117
|
|
|
|
419
|
|
|
|
341
|
|
Other income
(expense), net
|
|
|
178
|
|
|
|
117
|
|
|
|
419
|
|
|
|
341
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and total
comprehensive loss
|
|
$
|
(7,201)
|
|
|
$
|
(8,962)
|
|
|
$
|
(19,111)
|
|
|
$
|
(23,325)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(1.06)
|
|
|
$
|
(2.65)
|
|
|
$
|
(3.33)
|
|
|
$
|
(7.99)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
used in computing net loss per share, basic and diluted
|
|
|
6,816,339
|
|
|
|
3,380,763
|
|
|
|
5,733,007
|
|
|
|
2,921,201
|
|
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SOURCE Movano