Exhibit
99.1
ENDRA Life Sciences Provides Business Update and
Reports
Third Quarter 2019 Financial Results
●
Conference call scheduled for 4:30 p.m. ET today
ANN ARBOR, Michigan - November 13, 2019 - ENDRA Life
Sciences Inc. (“ENDRA”) (NASDAQ: NDRA), a pioneer of
Thermo Acoustic Enhanced UltraSound (TAEUS™), today provided
a business update and reported third quarter 2019 financial
results.
“ENDRA
has made important clinical and operational progress this quarter
as we move towards commercialization during 2020,” said
Francois Michelon, chairman and chief executive officer.
“Completion of part two of the feasibility study at Robarts
Research Institute represented a major milestone in the advancement
of our pioneering TAEUS technology. Initial findings support our
belief that TAEUS is positioned to be a practical tool for use with
other biomarkers in the management of NAFLD and NASH at the point
of patient care, and we are moving ahead with additional clinical
study sites and regulatory filings. We also continue to engage with
our key clinical audiences as we ramp up commercialization efforts
heading into 2020.”
Business Highlights
●
Reported top level
findings from part two of the feasibility study at Robarts Research
Institute.
●
Showcased the
pre-production TAEUS liver device1 for the first time at the Annual 2019
AASLD Liver Meeting.
●
Hosted Key Opinion
Leader (KOL) event in conjunction with the Annual 2019 AASLD Liver
Meeting featuring a presentation by Dr. Raza Malik, M.D., Ph.D.
Director of Hepatology and Associate Chief, Division of
Gastroenterology at Tufts Medical Center.
●
Increased
intellectual property (IP) portfolio to 60 assets defined, filed
and issued.
Financial Results for Quarter Ended September 30, 2019
●
Operating expenses
increased to $2.6 million in the third quarter of 2019, up from
$2.4 million in the third quarter of 2018. The increase in
operating expenses was primarily due to expenses related to the
development of our TAEUS product line, and costs associated with
the pre-commercialization of TAEUS.
●
Net loss in
Q3 2019 totaled $3.4 million, or ($0.46) per basic and diluted
share, as compared to a net loss of $2.8 million, or ($0.70) per
basic and diluted share in Q3 2018.
●
Cash at September
30, 2019 totaled $2.3 million, as compared to $6.5 million at
December 31, 2018, with no long-term debt outstanding.
Conference Call and Webcast Access
Management will host a conference call and webcast at 4:30 p.m. ET
to discuss the results and provide an update on recent corporate
developments.
Dial-in Number
U.S./Canada Dial-in Number: 844-602-0380
International Dial-in Number: 862-298-0970
Replay Dial-in Number: 877-481-4010
Replay International Dial-in Number: 919-882-2331
Replay Passcode: 56751
A telephone replay will be available November 13, 2019 through 4:30
p.m. ET on November 27, 2019.
A live audio webcast will be available through the Events and
Presentations page of the Investors section of the company's
website at www.endrainc.com.
A replay of the webcast will be available on the website for 90
days.
About ENDRA Life Sciences Inc.
ENDRA
Life Sciences Inc. is the pioneer of Thermo Acoustic Enhanced
UltraSound (TAEUS™), a ground-breaking technology that
mirrors some applications similar to CT or MRI, but at
50X lower cost, at
the point of patient care. TAEUS is designed to work in concert
with one million ultrasound systems in global use today. TAEUS is
initially focused on the measurement of fat in the liver, as a
means to assess and monitor NAFLD and NASH, chronic liver
conditions that affect over 1 billion people globally, and for
which there are no practical diagnostic tools. Beyond the liver,
ENDRA is exploring several other clinical applications of TAEUS,
including visualization of tissue temperature during energy-based
surgical procedures. 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, estimates of the timing of future
events and achievements, such as obtaining a CE Mark and
commercializing the TAEUS device; 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, 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:
MacDougall
Christi
Waarich
(781)
235-3060
endra@macbiocom.com
www.macbiocom.com
ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets
|
|
September
30,
|
December
31,
|
|
Assets
|
2019
|
2018
|
|
Assets
|
(Unaudited)
|
|
|
Cash
|
$2,275,302
|
$6,471,375
|
|
Prepaid
expenses
|
206,658
|
145,424
|
|
Inventory
|
127,831
|
59,444
|
|
Other current
assets
|
366,390
|
273,315
|
|
Total Current
Assets
|
2,976,181
|
6,949,558
|
|
Other
Assets
|
|
|
|
Fixed assets,
net
|
218,798
|
273,233
|
|
Right of use
assets
|
420,488
|
-
|
|
Total
Assets
|
$3,615,467
|
$7,222,791
|
|
|
|
|
|
Liabilities
and Stockholders’ Equity
|
|
|
|
Current
Liabilities:
|
|
|
|
Accounts payable
and accrued liabilities
|
$1,198,487
|
$974,583
|
|
Convertible notes
payable, net of discount
|
590,026
|
-
|
|
Lease liabilities,
current portion
|
65,295
|
-
|
|
Total Current
Liabilities
|
1,853,808
|
974,583
|
|
|
|
|
|
Long
Term Liabilities:
|
|
|
|
Lease
liabilities
|
358,915
|
-
|
|
Total Long Term
Liabilities
|
358,915
|
-
|
|
|
|
|
|
Total
Liabilities
|
2,212,723
|
974,583
|
|
|
|
|
|
Stockholders’
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; 7,516,875 and
7,422,642 shares issued and outstanding
|
751
|
742
|
|
Additional paid in
capital
|
37,590,359
|
33,939,162
|
|
Accumulated
deficit
|
(36,188,366)
|
(27,691,696)
|
|
Total
Stockholders’ Equity
|
1,402,744
|
6,248,208
|
|
Total
Liabilities and Stockholders’ Equity
|
$3,615,467
|
$7,222,791
|
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,
|
|
|
2019
|
2018
|
2019
|
2018
|
|
Revenue
|
$-
|
$-
|
$-
|
$6,174
|
|
|
|
|
|
|
|
Cost of Goods
Sold
|
-
|
-
|
-
|
-
|
|
|
|
|
|
|
|
Gross
Profit
|
$-
|
$-
|
$-
|
$6,174
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
Research and
development
|
1,468,441
|
1,162,911
|
4,546,746
|
3,671,490
|
|
Sales and
marketing
|
100,203
|
72,179
|
245,364
|
220,713
|
|
General and
administrative
|
1,071,889
|
832,884
|
2,920,815
|
2,842,631
|
|
Impairment of
inventory
|
-
|
287,541
|
-
|
287,541
|
|
Total operating
expenses
|
2,640,533
|
2,355,515
|
7,712,925
|
7,022,375
|
|
|
|
|
|
|
|
Operating
loss
|
(2,640,533)
|
(2,355,515)
|
(7,712,925)
|
(7,016,201)
|
|
|
|
|
|
|
|
Other
Expenses
|
|
|
|
|
|
Amortization of
debt discount
|
(728,417)
|
(377,606)
|
(728,417)
|
(383,428)
|
|
Other
expense
|
(44,612)
|
(25,455)
|
(55,328)
|
(31,022)
|
|
Total other
expenses
|
(773,029)
|
(403,061)
|
(783,745)
|
(414,450)
|
|
|
|
|
|
|
|
Loss from
operations before income taxes
|
(3,413,562)
|
(2,758,576)
|
(8,496,670)
|
(7,430,651)
|
|
|
|
|
|
|
|
Provision for
income taxes
|
-
|
-
|
-
|
-
|
|
|
|
|
|
|
|
Net
Loss
|
$(3,413,564)
|
$(2,758,576)
|
$(8,496,670)
|
$(7,430,651)
|
|
|
|
|
|
|
|
Net
loss per share – basic and diluted
|
$(0.46)
|
$(0.70)
|
$(1.14)
|
$(1.89)
|
|
|
|
|
|
|
|
Weighted
average common shares – basic and diluted
|
7,428,788
|
3,927,933
|
7,424,713
|
3,924,662
|
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
|
Nine Months Ended
|
Nine Months Ended
|
|
|
September 30,
|
September 30,
|
|
|
2019
|
2018
|
|
Cash
Flows from Operating Activities
|
|
|
|
Net
loss
|
$(8,496,670)
|
$(7,430,651)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
Depreciation and
amortization
|
59,673
|
48,246
|
|
Common stock,
options and warrants issued for services
|
1,020,300
|
1,060,012
|
|
Amortization of
debt discount
|
728,417
|
383,428
|
|
Impairment of
inventory
|
-
|
287,541
|
|
Changes in
operating assets and liabilities:
|
|
|
|
Increase in
accounts receivable
|
-
|
(5,425)
|
|
Increase in prepaid
expenses
|
(61,234)
|
(260,550)
|
|
Increase in
inventory
|
(68,387)
|
(95,861)
|
|
Increase in other
asset
|
(93,075)
|
(6,918)
|
|
Increase in
accounts payable and accrued liabilities
|
229,640
|
220,124
|
|
Net cash used in
operating activities
|
(6,681,336)
|
(5,800,054)
|
|
|
|
|
|
Cash
Flows from Investing Activities:
|
|
|
|
Purchases of fixed
assets
|
(5,238)
|
(100,000)
|
|
Net cash used in
investing activities
|
(5,238)
|
(100,000)
|
|
|
|
|
|
Cash
Flows from Financing Activities
|
|
|
|
Proceeds from
senior secured convertible promissory notes, net of
fees
|
2,490,501
|
935,300
|
|
Net cash provided
by financing activities
|
2,490,501
|
935,300
|
|
|
|
|
|
Net
Increase/(Decrease) in cash
|
(4,196,073)
|
(4,964,754)
|
|
|
|
|
|
Cash, beginning of
period
|
6,471,375
|
5,601,878
|
|
|
|
|
|
Cash,
end of period
|
$2,275,302
|
$637,124
|
|
|
|
|
|
Supplemental
disclosures of cash items:
|
|
|
|
Interest
paid
|
$-
|
$-
|
|
Income tax
paid
|
$-
|
$-
|
|
|
|
|
|
Supplemental
disclosures of non-cash items:
|
|
|
|
Discount on
convertible notes
|
$2,490,501
|
$587,541
|
|
Conversion of
convertible notes and accrued interest
|
$140,405
|
$50,000
|
|
Right of use
asset
|
$420,488
|
$-
|
|
Lease
liability
|
$424,210
|
$-
|