Attached files
Exhibit 99.1
ENDRA Life
Sciences Reports Third Quarter 2018 Financial
Results
Management to Host Conference Call Today at 4:30 p.m.
ET
ANN
ARBOR, MI / ACCESSWIRE / November 5, 2018 / ENDRA Life Sciences
Inc. (''ENDRA'') (NDRA), a
developer of enhanced ultrasound technologies, reported its
financial and operational results for the three and nine months
ended September 30, 2018.
Key Third Quarter 2018 and Subsequent
Highlights:
●
Issued an Investigational Testing
Authorization ("ITA") by Health Canada, allowing ENDRA to initiate
human studies with its Thermo-Acoustic Enhanced Ultrasound
("TAEUSTM") clinical system targeting Non-Alcoholic Fatty Liver
Disease ("NAFLD").
●
Showcased TAEUS™ NAFLD
application at the EASL Non-Alcoholic Fatty Liver Disease Summit in
Geneva, Switzerland in September 2018.
●
Granted three U.S. patents
supporting the TAEUS™ clinical product, bringing ENDRA's
total current intellectual property portfolio to 40 assets in
preparation, filed, issued or licensed, encompassing a range of
device and method-focused IP in targeted global markets,
including:
●
Commenced pre-commercialization
activities to raise industry awareness in anticipation of the
commercial launch in Europe in 2019, including 1) securing exhibit
space at notable liver disease and ultrasound industry events in
Basel, San Francisco and Chicago in November 2018 and 2) publishing
educational animations through social media and ENDRA's website
(endrainc.com).
●
In
October 2018, strengthened balance sheet with a public offering of
approximately 1.5 million shares of common stock, generating gross
proceeds of approximately $3.1 million.
Management
Commentary
"The third quarter of 2018 was
highlighted by continued progress towards the commercialization of
our proprietary Thermo-Acoustic Enhanced Ultrasound system," said
Francois Michelon, CEO of ENDRA Life Sciences.
"During the quarter we advanced
product development, expanded our intellectual property portfolio,
anchored by the granting of three new U.S. patents, and ramped up
pre-commercialization activities to raise awareness of our TAEUS
clinical product at key industry events within the hepatology,
radiology and ultrasound medical communities."
"While 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, TAEUS is a
highly scalable platform with multiple potential clinical
applications and revenue streams beyond liver disease. We believe
that our formal attendance at these events will allow us to gather
valuable insights from clinical thought leaders while
simultaneously generating leads for potential future early
adopters," continued Michelon.
"Most importantly Health Canada
issued ENDRA an Investigational Testing Authorization to commence
human studies with our Thermo-Acoustic Enhanced Ultrasound, or
TAEUS™, clinical system. The ITA application was reviewed
under a Class II designation and the study will be conducted in
collaboration with Imaging Laboratories at Robarts Research in
London, Canada. We received this approval subsequent to the closing
of the third quarter."
"Volunteer recruitment has been
strong and we expect initial studies to be completed in the coming
weeks with preliminary data expected sometime in December 2018.
This study will provide key insights into clinical workflow and
TAEUS' quantitative methodologies, an important step towards our
commercialization goals. It's also important to note that the
Canadian study is only the first of several planned clinical
studies for our fatty liver application," stated
Michelon.
"On the financial front, we
completed a public offering of common stock generating
approximately $3.1 million in gross proceeds to strengthen our
balance sheet and extend our operational runway towards
commercialization of the first TAEUS clinical product. This
offering was completed subsequent to the closing of the third
quarter and therefore it is not represented in our financial
statements as of September 30, 2018.
"As we now move towards the close
of the fourth quarter of 2018, we believe ENDRA is positioned to
deliver key milestones for ENDRA's Fatty Liver application in 2018
and 2019, including:
●
First
human study completed by December 2018, yielding insights into
TAEUS' quantitative methodologies, and supportive safety and human
factor data for its CE application;
●
Pre-commercialization awareness
building at key industry tradeshows in Q4 2018;
●
Quality management system
implementation to support applications to receive ISO certification
and CE mark in the first half of 2019; and
●
Commercial launch of TAEUS liver
device in Europe in the first half of 2019.
"As evidenced by the recent
positive developments in the liver disease and therapy landscape,
and based upon our conversations at industry tradeshows, we
continue to believe a diagnostic tool at the earliest stage of
liver disease (NAFLD) strategically positions ENDRA for substantial
adoption of its TAEUS clinical product once human data is obtained
and CE mark is granted. We look forward to speaking with investors
and analysts at upcoming investor and industry events in the months
ahead," concluded Michelon.
Third Quarter
2018 Financial Results
We had no revenue in Q3 2018,
compared to $0.3 million in Q3 2017. The revenue in 2017 was a
result of the sale of one of our Nexus 128 pre-clinical
systems.
Operating expenses increased to
$2.4 million in Q3 2018 as compared to $1.1 million in Q3 2017. The
increase in operating expenses was primarily due to increased
expenditures on research and development of ENDRA's TAEUS
technology, and the one time write down of inventory related to our
Nexus 128 product line.
Net loss in Q3 2018 totaled $2.8
million, or ($0.70) per basic and diluted share, as compared to a
net loss of $0.9 million, or ($0.23) per basic and diluted share,
in Q3 2017.
Cash at September 30, 2018 totaled
$0.6 million, as compared to $2.2 million at June 30, 2018.
Subsequent to the closing of the third quarter, the Company
completed a public offering of common stock, generating
approximately $3.1 million in gross proceeds.
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: Monday, November 5,
2018
Time: 4:30 p.m. EST, 1:30 p.m.
PST
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/39475
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 4:30 p.m. Eastern time through November 19,
2018.
Toll-free replay number:
1-877-481-4010
International replay number:
1-919-882-2331
Replay ID:
39475
About ENDRA Life
Sciences Inc.
ENDRA Life Sciences Inc. ("ENDRA")
(NDRA) is a
developer of enhanced ultrasound technologies. ENDRA is developing
a next generation Thermo-Acoustic Enhanced UltraSound
(TAEUS™) platform 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 (NAFLD). ENDRA's
goal is to bring new capabilities to ultrasound - thereby
broadening access to better healthcare. For more information,
please visit www.endrainc.com.
About
Non-Alcoholic Fatty Liver Disease (NAFLD)
NAFLD is a condition closely
associated with obesity, diabetes, hepatitis-C and certain genetic
predispositions in which fat accumulates in the liver. NAFLD
affects over 1 billion people globally and is estimated to cost the
U.S healthcare system over $100 billion annually. NAFLD is often
asymptomatic and if left untreated, NAFLD can progress to
inflammation (NASH), tissue scarring (fibrosis), cell death
(cirrhosis) and liver cancer. By 2025, NAFLD is forecast to be the
greatest root cause of liver transplants. The only tools currently
available for diagnosing and monitoring NAFLD are impractical:
expensive Magnetic Resonance Imaging (MRI) or an invasive surgical
biopsy.
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 the results of pending human
studies and nature of the data obtained from such trials; the
adequacy of protections afforded to us by the patents that we own
and the success we may have in, and the cost to us of, maintaining,
enforcing and defending those patents; expectations concerning
ENDRA's ability to secure regulatory approvals; anticipated product
pricing; expectations with respect to current and future
partnerships; 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.
Condensed
Consolidated Balance Sheets
|
|
September
30
|
December
31,
|
|
Assets
|
2018
|
2017
|
|
Assets
|
(unaudited)
|
|
|
Cash
|
$637,124
|
$5,601,878
|
|
Accounts
receivable
|
12,275
|
6,850
|
|
Prepaid
expenses
|
328,046
|
67,496
|
|
Inventory
|
-
|
191,680
|
|
Other current
assets
|
21,166
|
14,249
|
|
Total Current
Assets
|
998,611
|
5,882,153
|
|
Other
Assets
|
|
|
|
Fixed assets,
net
|
293,303
|
241,549
|
|
Total
Assets
|
$1,291,914
|
$6,123,702
|
|
|
|
|
|
Liabilities and
Stockholders’ (Deficit) Equity
|
|
|
|
Current
Liabilities:
|
|
|
|
Accounts payable and accrued
liabilities
|
$1,068,337
|
$848,214
|
|
Convertible notes payable, net of
discount
|
681,187
|
-
|
|
Total
Liabilities
|
1,749,524
|
848,214
|
|
|
|
|
|
Stockholders’
(Deficit) Equity
|
|
|
|
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; 3,947,828 and 3,923,027 shares issued
and outstanding
|
394
|
392
|
|
Additional paid in
capital
|
24,868,082
|
23,170,531
|
|
Accumulated
deficit
|
(25, 326,086)
|
(17,895,435)
|
|
Total Stockholders’ (Deficit)
Equity
|
(457,610)
|
5,275,488
|
|
Total
Liabilities and Stockholders’ Equity
|
$1,291,914
|
$6,123,702
|
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,
|
|
|
2018
|
2017
|
2018
|
2017
|
|
Revenue
|
$-
|
$287,000
|
$6,174
|
$344,772
|
|
|
|
|
|
|
|
Cost of Goods
Sold
|
-
|
118,270
|
-
|
169,697
|
|
|
|
|
|
|
|
Gross
Profit
|
$-
|
$168,730
|
$6,174
|
$175,075
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
Research and
development
|
1,162,911
|
300,527
|
3,671,490
|
571,066
|
|
Sales and
marketing
|
72,179
|
47,375
|
220,713
|
55,403
|
|
General and
administrative
|
832,883
|
731,762
|
2,842,631
|
1,878,093
|
|
Impairment of
inventory
|
287,541
|
-
|
287,541
|
-
|
|
Total operating
expenses
|
2,355,514
|
1,079,664
|
7,022,375
|
2,504,562
|
|
|
|
|
|
|
|
Operating loss
|
(2,355,514)
|
(910,934)
|
(7,016,201)
|
(2,329,487)
|
|
|
|
|
|
|
|
Other
Expenses
|
|
|
|
|
|
Other income
(expense)
|
(403,061)
|
2,026
|
(414,450)
|
(752,835)
|
|
Total other
expenses
|
(403,061)
|
2,026
|
(414,450)
|
(752,835)
|
|
|
|
|
|
|
|
Loss from operations before income
taxes
|
(2,758,575)
|
(908,908)
|
(7,430,651)
|
(3,082,322)
|
|
|
|
|
|
|
|
Provision for income
taxes
|
-
|
-
|
-
|
-
|
|
|
|
|
|
|
|
Net
Loss
|
$(2, 758,575)
|
$(908,908)
|
$(7,430,651)
|
$(3,082,322)
|
|
|
|
|
|
|
|
Net loss per
share – basic and diluted
|
$(0.70)
|
$(0.23)
|
$(1.89)
|
$(1.30)
|
|
|
|
|
|
|
|
Weighted average
common shares – basic and diluted
|
3,927,933
|
3,907,027
|
3,924,662
|
2,367,452
|
ENDRA Life
Sciences Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
|
|
Nine Months
Ended
|
Nine Months
Ended
|
|
|
September
30,
|
September
30,
|
|
|
2018
|
2017
|
|
Cash Flows from
Operating Activities
|
|
|
|
Net loss
|
$(7,430,651)
|
$(3,082,322)
|
|
Adjustments to reconcile net loss
to net cash used in operating activities:
|
|
|
|
Depreciation and
amortization
|
48,246
|
46,121
|
|
Common stock, options and warrants
issued for services
|
1,060,012
|
600,514
|
|
Interest on discount of convertible
debt
|
-
|
711,472
|
|
Imputed interest on promissory
notes
|
-
|
1,480
|
|
Amortization of debt
discount
|
383,428
|
-
|
|
Impairment of
inventory
|
287,541
|
-
|
|
Changes in operating assets and
liabilities:
|
|
|
|
Increase in accounts
receivable
|
(5,425)
|
-
|
|
Increase in prepaid
expenses
|
(260,550)
|
(101,254)
|
|
Increase in
inventory
|
(95,861)
|
(91,574)
|
|
Increase in other
asset
|
(6,918)
|
(1,887)
|
|
Increase/(decrease) in accounts
payable and accrued liabilities
|
220,124
|
(7,879)
|
|
Net cash used in operating
activities
|
(5,800,054)
|
(1,925,329)
|
|
|
|
|
|
Cash Flows from
Investing Activities:
|
|
|
|
Purchases of fixed
assets
|
(100,000)
|
(7,862)
|
|
Net cash used in investing
activities
|
(100,000)
|
(7,862)
|
|
|
|
|
|
Cash Flows from
Financing Activities
|
|
|
|
Proceeds from issuance of common
stock
|
-
|
8,590,700
|
|
Repayment of notes
payable
|
-
|
(50,000)
|
|
Proceeds from convertible
notes
|
935,300
|
225,000
|
|
Net cash provided by financing
activities
|
935,300
|
8,765,700
|
|
|
|
|
|
Net (Decrease)/Increase in
cash
|
(4,954,754)
|
6,832,509
|
|
|
|
|
|
Cash, beginning of
period
|
5,601,878
|
144,953
|
|
|
|
|
|
Cash, end of
period
|
$637,124
|
$6,977,462
|
|
|
|
|
|
Supplemental
disclosures:
|
|
|
|
Interest paid
|
$-
|
$-
|
|
Income tax paid
|
$-
|
$-
|
|
|
|
|
|
Supplemental disclosures of
non-cash Items:
|
|
|
|
Discount on convertible
notes
|
$587,541
|
$225,000
|
|
Conversion of convertible notes and
accrued interest
|
$50,000
|
$1,726,079
|