Attached files
| file | filename |
|---|---|
| 8-K - CURRENT REPORT - ENDRA Life Sciences Inc. | endra8k.htm |
Exhibit
99.1
ENDRA Life Sciences Reports Third Quarter 2017 Financial
Results
Partnerships with Leading Medical Device Developers &
Initiation of Human Studies Advance Anticipated 2018
Commercialization of Company’s TAEUS™ Fatty Liver
Product in Europe
ANN ARBOR, Michigan – November 15, 2017 - ENDRA Life Sciences Inc.
(“ENDRA”) (NASDAQ: NDRA), a developer of enhanced
ultrasound technologies, reported its financial and operational
results for the third quarter ended September 30,
2017.
Key Third Quarter 2017 and Subsequent Highlights:
●
Initiated a project
with the Centre for Imaging Technology Commercialization (CIMTEC)
to begin human studies with ENDRA’s Thermo-Acoustic Enhanced
Ultrasound (TAEUS™) clinical product targeting Non-Alcoholic
Fatty Liver Disease (NAFLD).
●
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.
●
Delivered and
installed a next-generation Nexus 128+ preclinical imaging system
at a leading research university in South Korea.
●
Presented new
photoacoustic imaging research at the 2017 World Molecular Imaging
Congress in Philadelphia.
●
Hired an IP
Specialist, engineering leader and specialized engineers with deep
knowledge of radio-frequency applications.
●
Strengthened
ENDRA’s total intellectual property estate to 33, with a
strong focus on protecting key enabling methodologies and technical
innovations related to our TAEUS fatty liver
application.
●
Rang the Nasdaq
Stock Market Closing Bell at the Nasdaq MarketSite in Times Square
with company management, board of directors and IPO
investors.
●
Presented at three
institutional investor conferences and two industry conferences in
New York, Philadelphia, Minneapolis and Florida.
Management Commentary
“During
the third quarter of 2017, we continued to meet key milestones and
execute our business plan,” said Francois Michelon,
ENDRA’s CEO. “We achieved all key 2017 milestones
outlined in our TAEUS liver roadmap and are on schedule to achieve
a successful commercial launch next year in the European
Union.
“Since
our initial public offering in May 2017, we have focused on three
primary areas:
1.
Building the ENDRA
team;
2.
Executing our
operating plan; and
3.
Growing investor
awareness.
1
“On
the commercialization front, we recently formalized our
relationship with the Centre for Imaging Technology
Commercialization (CIMTEC) to kick off human studies for our TAEUS
clinical product targeting NAFLD. This is one of several planned
commercial and academic collaborations to advance ENDRA’s
technology in the area of liver disease. These human studies with
CIMTEC will involve both conventional ultrasound and TAEUS imaging,
along with relevant blood markers and magnetic resonance imaging
(MRI). Our objective is to obtain important insight into clinical
work flow and quantitative methodologies of ENDRA's TAEUS™
product.
“To
support our new human studies, we also partnered with StarFish
Medical and CriTech Research to commence development on both the
hardware and software required for a commercial launch of our 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, each delivering key attributes to our
commercialization strategy. This diversified, two-pronged
productization approach will allow us to more quickly reach
commercialization, while best leveraging each partner’s
respective area of expertise,” continued
Michelon.
“The
third quarter represented another quarter of foundation building
and we believe the company is now positioned to succeed and achieve
all stated goals. With the renewal of our global collaboration
agreement with GE Healthcare, the global ultrasound market leader,
and continued adoption of our legacy Nexus 128 pre-clinical imaging
system by top research institutions worldwide, I have never been
more confident in ENDRA’s go-forward business
prospects.
“We
continue to meet key milestones on-time, while keeping our monthly
cash burn at a level that should provide ample runway to
commercialize our TAEUS liver product in 2018.
“Anticipated
key milestones for ENDRA’s Fatty Liver application in 2018
include:
o
First human
data;
o
CE Mark in Europe;
and
o
Commercial launch
in Europe.
“I
am confident that we will continue to create value for our
shareholders, and look forward to sharing more on our developing
story at the upcoming LD Micro Institutional Investor Conference on
December 6, 2017 in Los Angeles, California,” concluded
Michelon.
Third Quarter 2017 Financial Results
Revenue
totaled $0.3 million in Q3 2017 with associated direct costs of
$0.1 million. The revenue was a result of the sale of a Nexus 128
system for use in pre-clinical applications.
Operating
expenses increased to $1.1 million in Q3 2017 from $0.6 million in
Q3 2016. The increase in operating expenses 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.
2
Cash at
September 30, 2017 totaled $7.0 million, as compared to $0.1
million at December 31, 2016. The increase of cash as of September
30, 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.
Net
loss totaled $0.9 million, or ($0.23) per basic and diluted share,
in Q3 2017, compared to a net loss of $1.0 million, or ($1.35) per
basic and diluted share, in Q3 2016.
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:
Wednesday, November 15, 2017
Time:
4:30 p.m. ET, 1:30 p.m. PT
Toll-free
dial-in number: 1-877-397-0292
International
dial-in number: 1-719-457-2644
Conference
ID: 4056284
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://public.viavid.com/index.php?id=126860
and via the investor relations section of the company’s
website at www.endrainc.com.
A
replay of the conference call will be available from 7:30 p.m.
Eastern time on November 15, 2017 through November 29,
2017.
Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 4056284
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 (") system to enable clinicians
to visualize human tissue composition, function and temperature in
ways previously possible only on 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. 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
3
ENDRA Life
Sciences Inc.
Condensed Consolidated Balance Sheets
|
|
September
30,
|
December
31,
|
|
Assets
|
2017
|
2016
|
|
Assets
|
(Unaudited)
|
|
|
Cash
|
$6,977,462
|
$144,953
|
|
Prepaid
expenses
|
101,254
|
-
|
|
Inventory
|
131,679
|
40,105
|
|
Other current
assets
|
12,422
|
10,535
|
|
Total Current
Assets
|
7,222,817
|
195,594
|
|
Other
Assets
|
|
|
|
Fixed assets,
net
|
256,909
|
295,168
|
|
Total
Assets
|
$7,479,726
|
$490,761
|
|
|
|
|
|
Liabilities
and Stockholders’ Equity (Deficit)
|
|
|
|
Current
Liabilities
|
|
|
|
Accounts payable
and accrued liabilities
|
$312,042
|
$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
|
312,042
|
1,384,528
|
|
Total
Liabilities
|
312,042
|
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; 3,907,027
and 723,335 shares issued and outstanding at September 30, 2017 and
December 31, 2016
|
390
|
72
|
|
Stock
payable
|
-
|
81,000
|
|
Additional paid in
capital
|
22,768,089
|
11,543,634
|
|
Accumulated
deficit
|
(15,600,795)
|
(12,518,473)
|
|
Total
Stockholders’ Equity (Deficit)
|
7,167,684
|
(893,767)
|
|
Total
Liabilities and Stockholders’ Equity (Deficit)
|
$7,479,726
|
$490,761
|
4
ENDRA Life
Sciences Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
Three Months Ended
|
Three Months Ended
|
Nine Months Ended
|
Nine Months Ended
|
|
|
September 30,
|
September 30,
|
September 30,
|
September 30,
|
|
|
2017
|
2016
|
2017
|
2016
|
|
Revenue
|
$287,000
|
$-
|
$344,772
|
$-
|
|
Cost
of Goods Sold
|
118,270
|
-
|
169,697
|
-
|
|
Gross Profit
|
$168,730
|
$-
|
$175,075
|
$-
|
|
|
|
|
|
|
|
Operating Expenses
|
|
|
|
|
|
Research
and development
|
300,527
|
137,540
|
571,066
|
336,417
|
|
Sales
and marketing
|
47,375
|
16,040
|
55,403
|
26,197
|
|
General
and administrative
|
731,762
|
451,530
|
1,878,093
|
1,110,263
|
|
Total
operating expenses
|
1,079,664
|
605,110
|
2,504,562
|
1,472,877
|
|
Operating
loss
|
(910,934)
|
(605,110)
|
(2,329,487)
|
(1,472,877)
|
|
|
|
|
|
|
|
Other Expenses
|
|
|
|
|
|
Loss
on warrant exercise
|
-
|
-
|
-
|
(5,823)
|
|
Interest
expense
|
(2,026)
|
(372,789)
|
(752,835)
|
(607,789)
|
|
Total
other expenses
|
(2,026)
|
(372,789)
|
(752,835)
|
(607,789)
|
|
Loss
from operations before income taxes
|
(908,908)
|
(977,898)
|
(3,082,322)
|
(2,086,490)
|
|
Provision
for income taxes
|
-
|
-
|
-
|
-
|
|
Net Loss
|
$(908,908)
|
$(977,898)
|
$(3,082,322)
|
$(2,086,490)
|
|
Net loss per share – basic and diluted
|
$(0.23)
|
$(1.35)
|
$(1.30)
|
$(2.88)
|
|
Weighted average common shares – basic and
diluted
|
3,907,027
|
723,335
|
2,367,452
|
723,266
|
5
ENDRA Life
Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
|
Nine Months Ended
|
Nine Months Ended
|
|
|
September 30,
|
September 30,
|
|
|
2017
|
2016
|
|
Cash
Flows from Operating Activities
|
|
|
|
Net
loss
|
$(3,082,322)
|
$(2,086,490)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
Depreciation and
amortization
|
46,121
|
48,612
|
|
Common stock,
options and warrants issued for services
|
600,514
|
199,723
|
|
Additional warrants
issued during exchange
|
-
|
5,823
|
|
Amortization of
discount of convertible debt
|
711,472
|
561,812
|
|
Imputed interest on
promissory notes
|
1,480
|
-
|
|
Changes in
operating assets and liabilities:
|
|
|
|
Increase in prepaid
expenses
|
(101,254)
|
-
|
|
Increase in
inventory
|
(91,574)
|
(21,375)
|
|
Increase in other
assets
|
(1,887)
|
(439)
|
|
Increase (decrease)
in accounts payable and accrued liabilities
|
(7,879)
|
19,918
|
|
Net cash used in
operating activities
|
(1,925,329)
|
(769,459)
|
|
|
|
|
|
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
|
8,590,700
|
5,000
|
|
Proceeds from notes
payable
|
-
|
50,000
|
|
Repayment of notes
payable
|
(50,000)
|
-
|
|
Proceeds from
convertible notes
|
225,000
|
1,386,448
|
|
Net cash provided
by financing activities
|
8,765,700
|
1,441,448
|
|
|
|
|
|
Net increase in
cash
|
6,832,509
|
56,415
|
|
Cash, beginning of
period
|
144,953
|
19,128
|
|
Cash,
end of period
|
$6,977,462
|
$75,543
|
|
|
|
|
|
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
|
$-
|
6