Conference call begins at 8:30 a.m. Pacific time today
PLEASANTON, Calif., Nov. 15,
2023 /PRNewswire/ -- Today, Movano Health (Nasdaq:
MOVE), a purpose-driven healthcare solutions company at the
intersection of medtech and consumer devices and makers of the Evie
Ring, reported financial results for the three months ending
September 30, 2023 and provided a
business update.
Key highlights from the third quarter and recent weeks
include:
- The Company will begin selling its first product, the Evie
Ring, on November 20, ahead of Black
Friday. Customers will be able to place an order for the Evie Ring
exclusively through https://eviering.com/ for $269 and no additional subscription fees or
monthly costs. Customers can elect to receive a complimentary
sizing kit to find the right fit. The Company expects to begin
shipping rings to customers before the end of the year. In order to
drive sales of the Evie Ring, Movano Health has been executing a
comprehensive marketing campaign. The Company launched a new
commercial website for the Evie Ring on November 6, which offers a detailed and
interactive look at the female first features and benefits of the
Evie solution. Since then, the site has seen more than 200,000
visits. Movano Health's marketing campaign is focused on converting
its engaged lead list of over 120,000 consumers and driving new
conversion traffic to the site throughout the Q4 2023 holiday
shopping period and beyond by leveraging press reviews, influencer
content and new creative.
- In a recent 44-person blood pressure clinical study, Movano
Health's proprietary 4 x 6.7 mm System-on-a-Chip (SoC) and
prototype solution demonstrated a level of accuracy within the
standards recognized by the FDA for blood pressure monitoring
devices. Since implementing the Company's proprietary SoC into
clinical studies, which Movano Health spent over five years
developing and miniaturizing, the Company has seen a material
improvement in the accuracy of its blood pressure measurements.
Movano Health is planning additional multi-week clinical
trials both in house and with third party investigators to
determine whether periodic calibration is required and refine its
AI models on an individual patient basis. Subsequently, Movano
Health intends to conduct a pivotal trial for its 510(k) submission
to the FDA to commercialize a cuffless blood pressure wearable
device.
- Following the submission of its 510(k) application to the FDA
for the Evie Ring's pulse oximeter in July
2023, Movano Health has since received a letter from the FDA
requesting additional information, which was in line with the
Company's expectations. The Company has been in communication with
the agency and plans to submit its formal reply letter to the FDA
in Q1 2024. If clearance is received, it has the potential to
unlock a significant enterprise opportunity with partners across
healthcare.
- Movano Health has priced a $3.6
million underwritten public offering of 4,235,304 shares of
its common stock. The public offering price, before the
underwriters' discount and commissions, for each share of common
stock is $0.85. All of the securities
in the underwritten public offering are being sold by the Company.
The Company has granted the underwriter a 30-day option to purchase
up to an additional 15% of shares of common stock sold in the
offering at the public offering price, less the underwriting
discount. The offering is expected to close on November 17, 2023.
"We believe we've set the stage for the successful introduction
of Evie into the market on November
20 and are excited to embark on this new phase of our
journey as we shift from pre-revenue to a revenue-generating
company," said John Mastrototaro,
CEO of Movano Health. "The timing for such a product couldn't
be better with increased interest in medical grade technologies for
home use and a strong focus on women's health and empowerment.
With its thoughtful design, accurate data and meaningful
insights, we believe the Evie Ring holds immense potential for our
company, our stakeholders and the health and wellness of our future
customers."
"In addition to focusing on the launch of the Evie Ring, we are
also building a high-value healthcare solutions roadmap to
commercialize cuffless blood pressure and noninvasive glucose
monitoring solutions that leverage our SoC," said Michael Leabman, founder and CTO of Movano
Health. "During a Q3 2023 blood pressure clinical study, our
proprietary SoC and prototype solution demonstrated a level of
accuracy within the standards recognized by the FDA for blood
pressure monitoring devices. This was a significant breakthrough
for us, and while there's more work to do before we can file for
FDA clearance, we've taken a major step forward on the path to
commercialization of a cuffless blood pressure monitoring
device."
Third Quarter 2023 Financial Results and Recent Capital
Markets Activity
- Movano Health reported a net loss of $9.0 million and a loss of $(0.18) per basic and diluted share, in the third
quarter of 2023, compared with a net loss of $8.6 million and a loss of $(0.26) per basic and diluted share, in the third
quarter of 2022.
- The Company reported an operating loss of $9.1 million in the third quarter of 2023
compared to an operating loss of $8.7
million in the third quarter of 2022.
- Movano Health is a development stage company and, as such, the
Company did not generate revenue in either the second quarter of
2023 or the second quarter of 2022.
- The Company had $7.7 million in
cash and cash equivalents as of September
30, 2023, compared to $10.8
million in cash and cash equivalents as of December 2022. Pro forma for the expected
net proceeds of the equity offering announced on November 15, the Company had $10.8 million in cash and cash equivalents as of
September 30, 2023.
- The total number of shares outstanding was 50,805,951 as of
September 30, 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
8:30 a.m. PST (11:30 a.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.
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 and their healthcare professionals to utilize daily
medical-grade data as a tool to proactively monitor and manage
health outcomes. 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 the anticipated
closing of the public offering, plans with respect to commercial
launch of the Evie Ring, anticipated FDA clearance for the Evie
Ring and other products in development, 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.
Investor Contact:
J. Cogan, CFA
ir@movano.com
Movano
Inc.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands)
(Unaudited)
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2023
|
|
|
2022
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
7,669
|
|
|
$
|
10,759
|
|
Payroll tax credit,
current portion
|
|
|
250
|
|
|
|
379
|
|
Vendor
deposits
|
|
|
601
|
|
|
|
103
|
|
Prepaid expenses and
other current assets
|
|
|
657
|
|
|
|
405
|
|
Total current assets
|
|
|
9,177
|
|
|
|
11,646
|
|
Property and equipment,
net
|
|
|
363
|
|
|
|
443
|
|
Payroll tax credit,
noncurrent portion
|
|
|
667
|
|
|
|
667
|
|
Other assets
|
|
|
386
|
|
|
|
487
|
|
Total assets
|
|
$
|
10,593
|
|
|
$
|
13,243
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,955
|
|
|
$
|
557
|
|
Other current
liabilities
|
|
|
3,578
|
|
|
|
4,421
|
|
Total current liabilities
|
|
|
5,533
|
|
|
|
4,978
|
|
Noncurrent
liabilities:
|
|
|
|
|
|
|
|
|
Early exercised stock
option liability
|
|
|
47
|
|
|
|
136
|
|
Other noncurrent
liabilities
|
|
|
69
|
|
|
|
214
|
|
Total noncurrent liabilities
|
|
|
116
|
|
|
|
350
|
|
Total liabilities
|
|
|
5,649
|
|
|
|
5,328
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
5
|
|
|
|
3
|
|
Additional paid-in
capital
|
|
|
123,361
|
|
|
|
103,009
|
|
Accumulated
deficit
|
|
|
(118,422)
|
|
|
|
(95,097)
|
|
Total stockholders'
equity
|
|
|
4,944
|
|
|
|
7,915
|
|
Total liabilities and stockholders' equity
|
|
$
|
10,593
|
|
|
$
|
13,243
|
|
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,
|
|
|
|
2023
|
|
|
2022
|
|
|
2023
|
|
|
2022
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
$
|
5,636
|
|
|
$
|
5,146
|
|
|
$
|
13,701
|
|
|
$
|
13,849
|
|
Sales, general and
administrative
|
|
|
3,443
|
|
|
|
3,511
|
|
|
|
9,965
|
|
|
|
8,592
|
|
Total operating expenses
|
|
|
9,079
|
|
|
|
8,657
|
|
|
|
23,666
|
|
|
|
22,441
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(9,079)
|
|
|
|
(8,657)
|
|
|
|
(23,666)
|
|
|
|
(22,441)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense),
net:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other
income, net
|
|
|
117
|
|
|
|
55
|
|
|
|
341
|
|
|
|
39
|
|
Other income (expense), net
|
|
|
117
|
|
|
|
55
|
|
|
|
341
|
|
|
|
39
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,962)
|
|
|
$
|
(8,602)
|
|
|
$
|
(23,325)
|
|
|
$
|
(22,402)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,962)
|
|
|
$
|
(8,602)
|
|
|
$
|
(23,325)
|
|
|
$
|
(22,402)
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized
loss on available-for-sale securities
|
|
|
—
|
|
|
|
7
|
|
|
|
—
|
|
|
|
(3)
|
|
Total comprehensive loss
|
|
$
|
(8,962)
|
|
|
$
|
(8,595)
|
|
|
$
|
(23,325)
|
|
|
$
|
(22,405)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
|
(0.18)
|
|
|
$
|
(0.26)
|
|
|
$
|
(0.53)
|
|
|
$
|
(0.68)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
used in computing net loss per share,
basic and diluted
|
|
|
50,711,449
|
|
|
|
32,949,649
|
|
|
|
43,818,011
|
|
|
|
32,829,940
|
|
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SOURCE Movano