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| 8-K - CURRENT REPORT - ENDRA Life Sciences Inc. | ndra_8k.htm |
Exhibit 99.1
ENDRA Life Sciences Provides Business Update and Reports Second
Quarter 2020 Financial Results
ANN ARBOR, MI / ACCESSWIRE / August 17, 2020 / ENDRA Life
Sciences Inc. ("ENDRA") (NASDAQ:NDRA), the pioneer of Thermo
Acoustic Enhanced UltraSound (TAEUS®), today
provided a business update and reported second quarter 2020
financial results.
"During
the second quarter, we achieved another major milestone on the path
to commercializing TAEUS with our 510(k) Premarket Notification
submission to the U.S. Food and Drug Administration ("FDA")," said
Francois Michelon, Chairman and Chief Executive Officer. "The
submission represents the culmination of years of scientific
research, quality system implementation, clinical data collection,
and biocompatibility and safety testing. I'm very proud of the
ENDRA team, especially for working tirelessly through an
unprecedented global pandemic to ensure the submission was made on
the aggressive schedule we set before COVID-19 was a
consideration."
As
Renaud Maloberti, Chief Commercial Officer, explained, "The FDA
submission builds on the receipt of the CE Mark in Europe for our
TAEUS liver system in the first quarter and positions the company
to begin commercialization in two major markets in the second half
of 2020 to start positively impacting the lives of more than 1
billion people globally affected by Non-Alcoholic Fatty Liver
Disease (NAFLD) and Non-Alcoholic Steatohepatitis
(NASH)."
Q2 2020 and Recent Business Highlights
●
Completed 510(k)
Premarket Notification submission to the U.S. Food and Drug
Administration ("FDA") for TAEUS Fatty Liver Imaging Probe ("FLIP")
on schedule, setting stage for potential clearance and
commercialization in the U.S. in 2020.
●
Secured new
partnership with the Medical College of Wisconsin ("MCW"), a
world-renowned healthcare institution, for a clinical study of
ENDRA's Thermo-Acoustic Enhanced Ultrasound (TAEUS™) device
for assessing Non-Alcoholic Fatty Liver Disease ("NAFLD"). This
represents the third research partnership for ENDRA, which will
help bolster the clinical evidence and further establish the
clinical utility of the TAEUS device in patients with NAFLD, as
commercialization gets underway.
●
Advanced European
commercialization strategy, following CE Mark approval, including
advancing to final stages of establishing initial evaluation sites
in key markets, as well as hiring an initial salesperson in the
U.K. and identifying leading candidates in other key
markets.
●
Increased
intellectual property (IP) portfolio to 72 assets defined, filed
and issued, including key platform patents in the United States,
Europe and China to defend our technology and current and future
clinical applications for which there are currently no practical
clinical tools.
●
Remain on track
with key milestones of establishing clinical evaluation reference
sites in Q3 and initial sales in Europe in Q4 2020.
Financial Results for Quarter Ended March 31, 2020
●
Operating expenses
increased to $2.9 million in the second quarter of 2020, up from
$2.3 million in the same period in 2019. 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 Q2 2020
totaled $2.9 million, or ($0.20) per basic and diluted share, as
compared to a net loss of $2.3 million, or ($0.31) per basic and
diluted share in Q2 2019.
●
Cash balance at
June 30, 2020 was $749,000 and totaled approximately $2.4 million
as of August 14, 2020 due primarily to voluntary early warrant
conversions, compared to $6.2 million at December 31, 2019, with no
long-term debt outstanding.
Conference Call and Webcast Access
Management
will host a conference call and webcast today 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: 844-369-8774
International
Dial-in Number: 862-298-0844
Replay
Dial-in Number: 877-481-4010
Replay
International Dial-in Number: 919-882-2331
Replay
Passcode: 36535
A
telephone replay will be available August 17, 2020 through 4:30
p.m. ET on August 24, 2020.
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 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 the expectations listed above
under the heading "2020 Guidance"; making our 510(k) submission
with the FDA 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; the impact of COVID-19 on our
business plans; 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 Relations Contact:
Denise
DiMeglio
(610)
228-2102
denise@gregoryfca.com
Investor Relations Contact:
Joe
Hassett
(484)
686-6600
joeh@gregoryfca.com
ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets
|
|
June
30,
|
December
31,
|
|
Assets
|
2020
|
2019
|
|
Assets
|
(unaudited)
|
|
|
Cash
|
$748,561
|
$6,174,207
|
|
Prepaid
expenses
|
1,064,146
|
116,749
|
|
Inventory
|
340,687
|
113,442
|
|
Other current
assets
|
121,951
|
130,701
|
|
Total Current
Assets
|
2,275,345
|
6,535,099
|
|
Other
Assets
|
|
|
|
Fixed assets,
net
|
214,587
|
236,251
|
|
Right of use
assets
|
372,720
|
404,919
|
|
Total
Assets
|
$2,862,652
|
$7,176,269
|
|
|
|
|
|
Liabilities
and Stockholders' Equity
|
|
|
|
Current
Liabilities
|
|
|
|
Accounts payable
and accrued liabilities
|
$1,169,237
|
$1,708,525
|
|
Convertible notes
payable, net of discount
|
-
|
298,069
|
|
Lease liabilities,
current portion
|
71,085
|
66,193
|
|
Total Current
Liabilities
|
1240,322
|
2,072,787
|
|
|
|
|
|
Long
Term Debt
|
|
|
|
Loans
|
337,084
|
-
|
|
Lease
liabilities
|
308,366
|
342,812
|
|
Total Long Term
Debt
|
645,450
|
342,812
|
|
|
|
|
|
Total
Liabilities
|
1,885,772
|
2,415,599
|
|
|
|
|
|
Stockholders'
Equity
|
|
|
|
Series A Preferred
Stock , $0.0001 par value; 10,000 shares authorized; 896.225 and
6,338.490 shares issued and outstanding
|
1
|
1
|
|
Series B Preferred
Stock, $0.0001 par value; 1,000 shares authorized; 0 and 351.711
shares issued and outstanding
|
-
|
-
|
|
Common stock,
$0.0001 par value; 80,000,000 shares authorized; 16,437,491 and
8,421,401 shares issued and outstanding
|
1,644
|
842
|
|
Additional paid in
capital
|
52,227,904
|
49,933,736
|
|
Stock
payable
|
181,437
|
43,528
|
|
Accumulated
deficit
|
(51,434,106)
|
(45,217,437)
|
|
Total Stockholders'
Equity
|
976,880
|
4,760,670
|
|
Total
Liabilities and Stockholders' Equity
|
$2,862,652
|
$7,176,269
|
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
Three Months
Ended
|
Three Months
Ended
|
Six Months
Ended
|
Six Months
Ended
|
|
|
June
30,
|
June
30,
|
June
30,
|
June
30,
|
|
|
2020
|
2019
|
2020
|
2019
|
|
Operating
Expenses
|
|
|
|
|
|
Research and
development
|
$1,487,049
|
$1,304,808
|
$3,005,195
|
$3,078,306
|
|
Sales and
marketing
|
134,763
|
88,343
|
249,718
|
145,161
|
|
General and
administrative
|
1,269,467
|
932,021
|
2,737,212
|
1,848,924
|
|
Total operating
expenses
|
2,891,279
|
2,325,172
|
5,992,125
|
5,072,391
|
|
|
|
|
|
|
|
Operating
loss
|
(2,891,279)
|
(2,325,172)
|
(5,992,125)
|
(5,072,391)
|
|
|
|
|
|
|
|
Other
Expenses
|
|
|
|
|
|
Amortization of
debt discount
|
(3,858)
|
-
|
(232,426)
|
-
|
|
Other income
(expense)
|
1,265
|
(9,199)
|
7,882
|
(10,716)
|
|
Total other
expenses
|
(2,593)
|
(9,199)
|
(224,544)
|
(10,716)
|
|
|
|
|
|
|
|
Loss from
operations before income taxes
|
(2,893,872)
|
(2,334,371)
|
(6,216,669)
|
(5,083,107)
|
|
|
|
|
|
|
|
Provision for
income taxes
|
-
|
-
|
-
|
-
|
|
|
|
|
|
|
|
Net
Loss
|
$(2,893,872)
|
$(2,334,371)
|
$(6,216,669)
|
$(5,083,107)
|
|
|
|
|
|
|
|
Net
loss per share - basic and diluted
|
$(0.20)
|
$(0.31)
|
$(0.45)
|
$(0.68)
|
|
|
|
|
|
|
|
Weighted
average common shares - basic and diluted
|
14,735,662
|
7,422,642
|
13,803,215
|
7,422,642
|
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
|
Six Months
Ended
|
Six Months
Ended
|
|
|
June
30,
|
June
30,
|
|
|
2020
|
2019
|
|
Cash
Flows from Operating Activities
|
|
|
|
Net
loss
|
$(6,216,669)
|
$(5,083,107)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
Depreciation and
amortization
|
44,014
|
39,744
|
|
Common stock,
options and warrants issued for services
|
1,057,120
|
659,217
|
|
Amortization of
debt discount
|
232,426
|
|
|
Amortization of
right of use assets
|
32,199
|
|
|
Changes in
operating assets and liabilities:
|
|
|
|
Prepaid
expenses
|
(947,397)
|
(98,358)
|
|
Lease
liability
|
(29,554)
|
|
|
Inventory
|
(227,245)
|
(14,837)
|
|
Other
assets
|
8,750
|
(93,075)
|
|
Accounts payable
and accrued liabilities
|
(493,676)
|
391,809
|
|
Net cash used in
operating activities
|
(6,540,032)
|
(4,198,607)
|
|
|
|
|
|
Cash
Flows from Investing Activities
|
|
|
|
Purchases of fixed
assets
|
(22,350)
|
(5,238)
|
|
Net cash used in
investing activities
|
(22,350)
|
(5,238)
|
|
|
|
|
|
Cash
Flows from Financing Activities
|
|
|
|
Proceeds from
warrant exercise
|
50,438
|
-
|
|
Proceeds from
loans
|
337,084
|
-
|
|
Proceeds from
issuance of common stock
|
791,474
|
-
|
|
Payment for
settlement of notes with stock
|
(42,260)
|
-
|
|
|
|
|
|
Net cash provided
by financing activities
|
1,136,736
|
-
|
|
|
|
|
|
Net decrease in
cash
|
(5,425,646)
|
(4,203,845)
|
|
|
|
|
|
Cash, beginning of
period
|
6,174,207
|
6,471,375
|
|
|
|
|
|
Cash,
end of period
|
$748,561
|
$2,267,530
|
|
|
|
|
|
Supplemental
disclosures of cash items
|
|
|
|
Interest
paid
|
$1,920
|
$-
|
|
|
|
|
|
Supplemental
disclosures of non-cash items
|
|
|
|
Conversion of
convertible notes and accrued interest
|
$493,814
|
$-
|
|
Conversion of
Series A Convertible Preferred Stock
|
$636
|
$-
|
|
Conversion of
Series B Convertible Preferred Stock
|
$36
|
$-
|
|
Stock dividend
payable
|
$(137,909)
|
$-
|
|
Stock paid and
payable for services
|
$40,000
|
$-
|
|
Lease liability for
right of use asset at inception
|
$-
|
$439,355
|
SOURCE: ENDRA Life Sciences Inc.