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8-K - CURRENT REPORT - ENDRA Life Sciences Inc. | ndra_8k.htm |
Exhibit
99.1
ENDRA Life Sciences Reports Fourth Quarter and Full Year
2017
Financial Results
Management to Host Conference Call Today at 4:30 p.m.
EDT
ANN ARBOR, Michigan – March 20, 2018 - ENDRA Life Sciences
Inc. (“ENDRA”) (NASDAQ: NDRA), a developer of
enhanced ultrasound technologies, reported its financial and
operational results for the fourth quarter and full year ended
December 31, 2017.
Key 2017 and Subsequent Highlights:
●
Renewed global
collaboration agreement with GE Healthcare to accelerate
development of ENDRA's Thermo-Acoustic Enhanced UltraSound
(TAEUS™) clinical platform.
●
Completed initial
public offering, as well as the exercise of over-allotment option,
which generated $8.6 million in net proceeds.
●
Rang the Nasdaq
Stock Market Closing Bell at the Nasdaq MarketSite in Times Square
with company management, board of directors and IPO
investors.
●
Hired strategic
personnel including an IP Specialist, engineering leader and
specialized engineers with deep knowledge of radio-frequency
applications.
●
Presented new
photoacoustic imaging research at the 2017 World Molecular Imaging
Congress in Philadelphia.
●
Delivered and
installed a next-generation Nexus 128+ preclinical imaging system
at a leading research university in South Korea.
●
Partnered with
StarFish Medical and CriTech Research to advance development of the
TAEUS clinical product meeting CE regulatory requirements for
anticipated 2018 commercial launch in the European
Union.
●
Initiated a project
with the Centre for Imaging Technology Commercialization (CIMTEC)
to conduct human studies with ENDRA’s Thermo-Acoustic
Enhanced Ultrasound (TAEUS™) clinical product targeting
Non-Alcoholic Fatty Liver Disease (NAFLD).
●
Strengthened
ENDRA’s total 2017 intellectual property portfolio to 33
patents and patent applications that are in preparation, filed,
issued or licensed, encompassing a range of device and
method-focused IP in targeted global markets.
●
Attended and
presented at six institutional investor conferences and two
industry conferences in New York, California, Pennsylvania,
Minnesota and Florida.
●
Subsequent
Events in Q1 2018:
o
Further renewed and
extended terms of global collaboration agreement with GE Healthcare
to accelerate development of ENDRA's Thermo-Acoustic Enhanced
UltraSound (TAEUS™) clinical platform.
o
Granted two U.S.
patents for non-invasive fat assessment to support TAEUS™
clinical product targeting Non-Alcoholic Fatty Liver
Disease.
Management Commentary
“2017
was a pivotal year for ENDRA as we successfully completed our IPO,
strategically deployed our capital, expanded the team and achieved
several operational milestones,” said Francois Michelon,
ENDRA’s CEO. “On the heels of a renewed global
collaboration agreement with GE Healthcare, the global ultrasound
market leader, we raised $8.6 million in new capital, listed on the
NASDAQ Capital Market and positioned ENDRA to acquire CE
certification and deliver its first liver diagnostic tool for the
European market in 2018.
“For
those new to the ENDRA story, our disruptive clinical technology in
development leverages our photo-acoustic Nexus-128 technology,
which is currently used by world-class researchers at Stanford
University and the University of Michigan. ENDRA’s
Thermo-Acoustic Enhanced UltraSound (TAEUS™) clinical
platform combines RF pulses and ultrasound to visualize human
tissue composition, function and temperature in ways previously
possible only on CT & MRI and at a fraction of the total cost.
Our first TAEUS application will focus on the assessment of fat in
the liver, for early detection and monitoring of Non-Alcoholic
Fatty Liver Disease (NAFLD), which affects over one billion people
globally.
“During
2017, we began building the foundation for the successful
commercial launch of our TAEUS clinical product in the second half
of 2018. To support this, we hired strategic personnel including an
IP specialist, engineering leader, and specialized engineers with
deep knowledge of radio-frequency applications. On the IP front, we
also strengthened ENDRA’s total intellectual property
portfolio from 24 to 33 assets in 2017, with a strong focus on
protecting enabling methodologies and technical innovations related
to our TAEUS fatty liver application.
“On
the pre-commercialization front in 2017, we formalized our
relationship with the Centre for Imaging Technology
Commercialization (CIMTEC) to complete human studies for our TAEUS
clinical product targeting NAFLD expected in the second quarter of
2018. These human studies with CIMTEC involve conventional
ultrasound, TAEUS imaging and magnetic resonance imaging (MRI). Our
objective is to obtain important insights into clinical work flow
and quantitative methodologies of ENDRA's TAEUS™
product,” continued Michelon.
“To
support ENDRA’s human studies and commercialization plans, in
the fourth quarter of 2017 we also partnered with StarFish Medical
and CriTech Research to advance the development of the hardware and
software elements of the TAEUS clinical product. StarFish Medical
is Canada’s largest medical device development and contract
manufacturing company, while CriTech Research is an industry leader
in medical device software development. This diversified,
two-pronged productization approach will allow us to best leverage
each partner’s respective area of expertise.
“2018
is already off to an exciting start as evidenced by the accelerated
renewal of our collaboration agreement with GE Healthcare. We
believe this continues to demonstrate GE’s confidence with
our development progress in 2017 and signals their continued
support with development and commercialization of ENDRA’s
TAEUS fatty liver product in Europe.
“We
also expanded our patent portfolio in 2018 and were recently
granted two U.S. patents for non-invasive fat assessment to support
TAEUS™ clinical product targeting Non-Alcoholic Fatty Liver
Disease. These are the first U.S. patents issued to ENDRA for
non-invasive fat assessment, and we expect to receive additional
patents to protect our thermoacoustic intellectual property. As of
today, ENDRA's IP portfolio totals 39 patents and patent
applications that are in preparation, filed, issued or licensed,
encompassing a range of device and method-focused IP in targeted
global markets.
“As
we conclude the first quarter of 2018, we believe ENDRA is
positioned to deliver on key milestones for ENDRA’s Fatty
Liver application in 2018 including:
o
First human study
completed in the second quarter of 2018;
o
CE Mark in Europe
expected in the third quarter of 2018; and
o
Commercial launch
of the TAEUS liver device in Europe in the second half of
2018.
“We
look forward to sharing more on our developing story at the
upcoming MicroCap Conference on April 9-10, 2018 in New York
City,” concluded Michelon.
Fourth Quarter and Full Year 2017 Financial Results
Revenue
totaled $0.4 million in FY 2017, as compared to $0.5 million in FY
2016. The revenue for 2017 was a result of the sale of a new Nexus
128 system for use in pre-clinical applications, and service on the
base of existing installed Nexus 128 systems versus 2016 revenue
that was a result of the sale of two new Nexus 128 systems, and
service on the base of existing installed Nexus 128
systems.
Operating
expenses increased to $4.8 million in FY 2017 as compared to $2.1
million in FY 2016. The increase in operating expenses in FY 2017
as compared to FY 2016 was primarily due to higher research and
development expenses, and general & administrative expenses
associated with an increase in headcount, as well as one-time
advisory and accounting fees related to the company’s initial
public offering.
Net
loss in FY 2017 totaled $5.4 million, or ($1.95) per basic and
diluted share, as compared to a net loss of $2.8 million in FY
2016.
Cash at
December 31, 2017 totaled $5.6 million, as compared to $0.1 million
at December 31, 2016 with no long-term debt outstanding. The
increase of cash as of December 31, 2017 compared to December 31,
2016 is a result of the net proceeds of $8.6 million from the
company’s initial public offering in May 2017.
Conference Call
ENDRA
CEO Francois Michelon, CFO David Wells and CTO Michael Thornton
will host a conference call, followed by a question and answer
period.
To
access the call, please use the following information:
Date:
|
Tuesday,
March 20, 2018
|
Time:
|
4:30
p.m. ET, 1:30 p.m. PT
|
Toll-free
dial-in number:
|
1-877-407-8035
|
International
dial-in number:
|
1-201-689-8035
|
Please
call the conference telephone number 5-10 minutes prior to the
start time. An operator will register your name and organization.
If you have any difficulty connecting with the conference call,
please contact MZ Group at 1-949-491-8235.
The
conference call will be broadcast live and available for replay at
http://www.investorcalendar.com/event/26717
and via the investor relations section of the Company’s
website at www.endrainc.com.
A
replay of the conference call will be available after 7:30 p.m.
Eastern time through April 3, 2018.
Toll-free
replay number:
|
1-877-481-4010
|
International
replay number:
|
1-919-882-2331
|
Replay
ID:
|
26717
|
About ENDRA Life Sciences Inc.
ENDRA
Life Sciences Inc. ("ENDRA") (NASDAQ: NDRA) is a developer of
enhanced ultrasound technologies. ENDRA's Photo-Acoustic Nexus-128
system is currently used by leading global medical researchers to
screen and modify disease models with high image quality and volume
scanning speed. ENDRA is developing a next generation
Thermo-Acoustic Enhanced UltraSound (TAEUS™) system to enable
clinicians to visualize human tissue composition, function and
temperature in ways previously possible only with CT & MRI - at
a fraction of the cost, and at the point-of-care. ENDRA's first
TAEUS application will focus on the quantification of fat in the
liver, for early detection and monitoring of Non-Alcoholic Fatty
Liver Disease, which affects over 1 billion people globally,
representing an estimated $13 billion global ultrasound market
opportunity. ENDRA's goal is to bring new capabilities to
ultrasound - thereby broadening access to better healthcare. For
more information, please visit www.endrainc.com.
Forward-Looking Statements
All
statements in this release that are not based on historical fact
are “forward-looking statements” within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements, which
are based on certain assumptions and describe our future plans,
strategies and expectations, can generally be identified by the use
of forward-looking terms such as "believe," "expect," "may,"
"will," "should," "could," "seek," "intend," "plan," "goal,"
"estimate," "anticipate" or other comparable terms. Examples of
forward-looking statements include, among others, statements we
make regarding expectations concerning ENDRA’s ability to
secure regulatory approvals; anticipated product pricing;
expectations with respect to current and future partnerships,
including those with CIMTEC, StarFish and Critech; estimates of the
timing of future events and achievements; and expectations
concerning ENDRA’s business strategy. Forward-looking
statements involve inherent risks and uncertainties which could
cause actual results to differ materially from those in the
forward-looking statements, as a result of various factors
including, among others, the following: our ability to develop a
commercially feasible technology; receipt of necessary regulatory
approvals; our ability to find and maintain development partners,
market acceptance of our technology, the amount and nature of
competition in our industry; our ability to protect our
intellectual property; and the other risks and uncertainties
described in ENDRA’s filings with the Securities and Exchange
Commission. The forward-looking statements made in this release
speak only as of the date of this release, and ENDRA assumes no
obligation to update any such forward-looking statements to reflect
actual results or changes in expectations, except as otherwise
required by law.
Company Contact:
David
Wells
Chief
Financial Officer
(734)
997-0464
investors@endrainc.com
www.endrainc.com
Media & Investor Relations Contact:
MZ North America
Chris Tyson
Managing Director
(949) 491-8235
NDRA@mzgroup.us
www.mzgroup.us
ENDRA Life
Sciences Inc.
Consolidated Balance Sheets
|
December
31,
|
December
31,
|
Assets
|
2017
|
2016
|
Assets
|
|
|
Cash
|
$5,601,878
|
$144,953
|
Accounts
receivable
|
6,850
|
-
|
Prepaid
expenses
|
67,497
|
-
|
Inventory
|
191,680
|
40,105
|
Other current
assets
|
14,249
|
10,535
|
Total Current
Assets
|
5,882,154
|
195,594
|
Other
Assets
|
|
|
Fixed assets,
net
|
241,549
|
295,168
|
Total
Assets
|
$6,123,702
|
$490,761
|
|
|
|
Liabilities
and Stockholders’ Equity (Deficit)
|
|
|
Current
Liabilities:
|
|
|
Accounts payable
and accrued liabilities
|
$848,214
|
$434,552
|
Notes
payable
|
-
|
50,000
|
Convertible notes
payable, related party, net of discount
|
-
|
99,804
|
Convertible notes
payable, net of discount
|
-
|
800,172
|
Total Current
Liabilities
|
848,214
|
1,384,528
|
Total
Liabilities
|
848,214
|
1,384,528
|
|
|
|
Stockholders’
Equity (Deficit)
|
|
|
Preferred stock,
$0.0001 par value; 10,000,000 shares authorized; no shares issued
or outstanding
|
-
|
-
|
Common stock,
$0.0001 par value; 50,000,000 shares authorized; 3,923,027 and
723,335 shares issued and outstanding
|
392
|
72
|
Stock
payable
|
-
|
81,000
|
Additional paid in
capital
|
23,170,531
|
11,543,634
|
Accumulated
deficit
|
(17,895,435)
|
(12,518,473)
|
Total
Stockholders’ Equity (Deficit)
|
5,275,488
|
(893,767)
|
Total
Liabilities and Stockholders’ Equity (Deficit)
|
$6,123,702
|
$490,761
|
ENDRA Life
Sciences Inc.
Condensed Consolidated Statements of Operations
|
Year Ended
|
Year Ended
|
|
December 31,
|
December 31,
|
|
2017
|
2016
|
Revenue
|
$351,622
|
$515,582
|
|
|
|
Cost
of Goods Sold
|
172,782
|
235,878
|
|
|
|
Gross Profit
|
$178,840
|
$279,704
|
|
|
|
Operating Expenses
|
|
|
Research
and development
|
1,931,075
|
495,377
|
Sales
and marketing
|
122,604
|
34,130
|
General
and administrative
|
2,751,219
|
1,541,955
|
Total
operating expenses
|
4,804,898
|
2,071,461
|
|
|
|
Operating
loss
|
(4,626,058)
|
(1,791,758)
|
|
|
|
Other Expenses
|
|
|
Loss
on warrant exercise
|
-
|
(5,823)
|
Other
income (expense)
|
(750,904)
|
(977,787)
|
Total
other expenses
|
(750,904)
|
(983,610)
|
|
|
|
Loss
from operations before income taxes
|
(5,376,962)
|
(2,775,368)
|
|
|
|
Provision
for income taxes
|
-
|
-
|
|
|
|
Net Loss
|
$(5,376,962)
|
$(2,775,368)
|
|
|
|
Net
loss per share – basic and diluted
|
$(1.95)
|
$(3.84)
|
|
|
|
Weighted average common shares – basic and
diluted
|
2,756,956
|
723,283
|
ENDRA Life
Sciences Inc.
Consolidated Statements of Cash Flows
|
Year Ended
|
Year Ended
|
|
December 31,
|
December 31,
|
|
2017
|
2016
|
Cash
Flows from Operating Activities
|
|
|
Net
loss
|
$(5,376,962)
|
$(2,775,369)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation and
amortization
|
61,481
|
64,936
|
Common stock,
options and warrants issued for services
|
1,002,957
|
208,723
|
Addition warrants
issued during exchange
|
-
|
5,823
|
Interest on
discount of convertible debt
|
711,472
|
899,976
|
Imputed interest on
promissory notes
|
1,480
|
3,704
|
Changes in
operating assets and liabilities:
|
|
|
Increase in
accounts receivable
|
(6,850)
|
-
|
Increase in prepaid
expenses
|
(67,497)
|
-
|
Increase (decrease)
in inventory
|
(151,574)
|
58,899
|
Increase in other
asset
|
(3,714)
|
(2,049)
|
Increase in
accounts payable and accrued liabilities
|
528,294
|
198,131
|
Net cash used in
operating activities
|
(3,300,914)
|
(1,315,623)
|
|
|
|
Cash
Flows from Investing Activities:
|
|
|
Purchases of fixed
assets
|
(7,862)
|
-
|
Net cash used in
investing activities
|
(7,862)
|
-
|
|
|
|
Cash
Flows from Financing Activities
|
|
|
Proceeds from
issuance of common stock, net
|
8,590,700
|
5,000
|
Proceeds from notes
payable
|
-
|
50,000
|
Repayment of notes
payable
|
(50,000)
|
132,000
|
Proceeds from
convertible notes
|
225,000
|
1,254,448
|
Net cash provided
by financing activities
|
8,765,700
|
1,466,756
|
|
|
|
Net
Increase/(Decrease) in cash
|
5,456,924
|
125,825
|
|
|
|
Cash, beginning of
period
|
144,953
|
19,128
|
|
|
|
Cash,
end of period
|
$5,601,878
|
$144,953
|
|
|
|
Supplemental
disclosures:
|
|
|
Interest
paid
|
$-
|
$-
|
Income
tax paid
|
$-
|
$-
|
|
|
|
Supplemental
disclosures of non-cash Items:
|
|
|
Discount on
convertible notes
|
$225,000
|
$-
|
Common shares to be
issued for accrued salaries - related parties
|
$-
|
$60,910
|
Conversion of
convertible notes and accrued interest
|
$1,726,079
|
$-
|