Prepares for September
17, 2024, Evie Ring back in stock date
Announces
brand partnership with digital creator Heidi
D'Amelio
Focuses on launch of EvieMED and securing B2B
opportunities
Conference Call at 2:00 PM PT/ 5:00 PM
ET Today
PLEASANTON, Calif., Aug. 14,
2024 /PRNewswire/ -- Movano Health (Nasdaq:
MOVE), a pioneer in health technology, reported second quarter 2024
results and provided a business update.
Following the successful close of the Company's April 2024 $24.1
million private placement that included a seed investment
from a tier 1 multi-billion dollar medical device company, Movano
Health has been focused on three key initiatives:
- Preparing for the September
17th back in stock date for the Evie Ring,
including an enhanced product experience, improved operations
processes, and bolstered customer service.
- Today, the Company announced an Evie Ring brand partnership
with digital creator, wife, mom, and entrepreneur Heidi
D'Amelio.
- Securing FDA 510(k) clearance for the EvieMED Ring and pursuing
initial business-to-business (B2B) commercial agreements across the
healthcare sector. The Company is scheduled to meet live with its
FDA counterparts in mid-August.
- Advancing cuffless blood pressure and noninvasive glucose
monitoring clinical studies with Movano Health's proprietary and
patented System-on-a-Chip (SoC).
"We are excited to be back in stock on the Evie Ring and have
been laser focused over the past quarter on improving the consumer
experience across product, delivery and customer service in order
to maximize our sales potential," said John
Mastrototaro, CEO and President of Movano Health.
"Additionally, we are committed to working collaboratively with the
FDA to obtain a 510(k) clearance for EvieMED, the cornerstone of
our enterprise initiative."
Recent Operating Highlights and Milestones
- On April 4, 2024, Movano Health
closed a $24.1 million private
placement, totaling 45.3 million units, with each unit consisting
of one share of the Company's common stock (or pre-funded warrant
in lieu thereof) and one warrant to purchase a share of common
stock, to a select group of investors that included a tier-one
multi-billion dollar medical device company, institutional and
accredited investors, and members of the Company's management team
and board of directors.
- On April 21, 2024, Movano Health
successfully submitted updated pivotal clinical trial results as
well as proof of enhanced medical device usability to the U.S. Food
and Drug Administration (FDA) as part of its 510(k) filing for the
Company's first commercial medical device, the EvieMED Ring pulse
oximeter. The Company recently announced that it will be meeting
live with the FDA in mid-August to discuss the wellness aspects of
EvieMED and to move forward with the review process.
- On June 10, 2024, Movano Health
announced a clinical study partnership with the Massachusetts Institute of Technology (MIT)'s MAESTRO study of the long term effects of
Chronic Lyme and Long Covid, using the continuous health monitoring
capabilities of the Evie Ring.
- In the second quarter, Movano Health made important progress
with three additional B2B commercial opportunities that could
leverage EvieMED in building unique solutions for both clinical and
consumer applications. In the first case, the Company is in the
agreement phase with a global pharmaceutical company for a program
that could begin in late-2024, and, assuming success, would be
expected to develop into a larger commercial opportunity in 2025.
In the second case, EvieMED is expected to be evaluated this Fall
by a tier 1 global pharmaceutical company for a clinical trial that
is scheduled to commence in 2025. Finally, Movano Health is engaged
with a large payor looking to better manage high risk populations
utilizing EvieMED. This opportunity is expected to commence in
late-2024/early-2025 and could develop further into calendar
2025.
- In June 2024, Movano Health
completed a cuffless blood pressure clinical study that included
the use of an arterial blood pressure line. The Company plans to
execute another cuffless blood pressure clinical study in the
fourth quarter of 2024.
Second Quarter 2024 and Recent Financial Highlights
- In Q2 2024, Movano Health shipped 1,837 Evie Rings. The Company did not report revenue
in the period, as previously deferred revenue was offset by
customer refunds.
- The Company reported an operating loss of $6.4 million in Q2 2024, compared to an operating
loss of $7.4 million in Q2 2023.
- Total cash and cash equivalents at June
30, 2024 were $16.9
million.
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's proprietary technologies and wearable medical
device solutions will soon enable the 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2024
|
|
2023
|
|
|
|
|
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
16,868
|
|
$
6,118
|
Payroll tax credit,
current portion
|
|
233
|
|
450
|
Vendor
deposits
|
|
22
|
|
399
|
Inventory
|
|
1,790
|
|
1,114
|
Prepaid expenses and
other current assets
|
|
776
|
|
442
|
Total current
assets
|
|
19,689
|
|
8,523
|
Property and equipment,
net
|
|
272
|
|
342
|
Payroll tax credit,
noncurrent portion
|
|
55
|
|
169
|
Other assets
|
|
810
|
|
387
|
Total assets
|
|
$
20,826
|
|
$
9,421
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
1,538
|
|
$
3,118
|
Deferred
revenue
|
|
—
|
|
1,252
|
Other current
liabilities
|
|
1,883
|
|
1,529
|
Total current
liabilities
|
|
3,421
|
|
5,899
|
Noncurrent
liabilities:
|
|
|
|
|
Early exercised stock
option liability
|
|
4
|
|
23
|
Other noncurrent
liabilities
|
|
623
|
|
50
|
Total noncurrent
liabilities
|
|
627
|
|
73
|
Total
liabilities
|
|
4,048
|
|
5,972
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common stock
|
|
10
|
|
6
|
Additional paid-in
capital
|
|
153,058
|
|
127,823
|
Accumulated
deficit
|
|
(136,290)
|
|
(124,380)
|
Total stockholders'
equity
|
|
16,778
|
|
3,449
|
Total liabilities and
stockholders' equity
|
|
$
20,826
|
|
$
9,421
|
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,
|
|
|
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
$
—
|
|
$
—
|
|
$
852
|
|
$
—
|
|
|
|
|
|
|
|
|
|
|
|
COSTS AND
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
Cost of
revenue
|
|
|
|
380
|
|
—
|
|
1,595
|
|
—
|
Research and
development
|
|
|
|
2,907
|
|
4,171
|
|
5,794
|
|
8,065
|
Sales, general and
administrative
|
|
|
|
3,110
|
|
3,213
|
|
5,614
|
|
6,522
|
Total costs and
expenses
|
|
|
|
6,397
|
|
7,384
|
|
13,003
|
|
14,587
|
Loss from
operations
|
|
|
|
(6,397)
|
|
(7,384)
|
|
(12,151)
|
|
(14,587)
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense),
net:
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income, net
|
|
|
|
207
|
|
117
|
|
241
|
|
224
|
Other income (expense), net
|
|
|
|
207
|
|
117
|
|
241
|
|
224
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and total
comprehensive loss
|
|
|
|
$
(6,190)
|
|
$
(7,267)
|
|
$
(11,910)
|
|
$
(14,363)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
|
|
$
(0.06)
|
|
$
(0.17)
|
|
$
(0.15)
|
|
$
(0.36)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
used in computing net loss per share, basic and diluted
|
|
99,538,371
|
|
43,056,785
|
|
77,780,822
|
|
40,314,164
|
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SOURCE Movano