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8-K - CURRENT REPORT - ENDRA Life Sciences Inc. | ndra_8k.htm |
Exhibit 99.1
ENDRA Life Sciences Reports
Third Quarter 2020 Financial Results and Provides Business Update
Conference call begins at 4:30 p.m. Eastern time today
ANN ARBOR, MI / ACCESSWIRE / November 16, 2020
/ ENDRA Life Sciences
Inc. ("ENDRA") (NASDAQ:NDRA),
the pioneer of Thermo Acoustic Enhanced UltraSound
(TAEUS®),
today reported financial results for the three months ended
September 30, 2020 and provided a
business update. Highlights of the third quarter of 2020 and
recent weeks include:
●
Installed the first TAEUS system at Rocky Vista
University College of Osteopathic Medicine (RVUCOM), one of three
research partnerships for ENDRA. The data from the RVUCOM study,
along with other announced and future studies, will bolster the
clinical evidence base and support the clinical utility of the TAEUS system in
patients with non-alcoholic fatty liver disease (NAFLD) and
inflammation (NASH) to support current
and future commercialization efforts.
●
Secured the first
clinical evaluation reference site in Germany and advanced two more
European sites to final legal review,
which the Company expects to execute before the end of the year.
The Company also continued efforts to build out its strategic
salesforce with key hires in the U.K. and Germany, while also
identifying leading candidates in other major European
markets.
●
Showcased TAEUS technology at important
clinical conferences and trade shows,
including The Digital International Liver Congress (ILC), hosted by
the European Association for the Study of the Liver (EASL),
and The Liver Meeting, sponsored by the American Association
for the Study of Liver Diseases (AASLD). ENDRA’s
participation in these conferences helped to expand its qualified sales pipeline to more than
4,000 global clinicians,
highlighting its unique position where there are no other
practical clinical tools currently available.
●
Increased its intellectual property portfolio to
76 assets, up from 64 at the end of 2019, including adding key
platform patents in the United States, Europe and China to
protect current and future clinical applications of the
Company’s technology.
●
Received approximately $5 million from the early
exercise of common stock warrants. These proceeds extend
ENDRA’s cash runway
through key business inflection points, including establishing
evaluation reference sites and initial sales in Europe, as well as
the potential receipt of FDA clearance to begin commercialization
in the U.S.
●
Remained on track to execute key milestones of establishing additional clinical
evaluation reference sites in Europe in the fourth quarter
of 2020.
Commenting
on the quarter and recent weeks, Francois Michelon, chairman and
chief executive officer of ENDRA, said, "I’m pleased with our
continued progress to keep the company on track during these
challenging times, including advancing our key European
commercialization initiatives, as well as installing the first
TAEUS system at Rocky Vista. In addition, we continue to work with
the U.S. Food and Drug Administration to respond to questions
related to our 510(k) Premarket Notification submission, with
expectations that TAEUS will receive clearance.”
Renaud
Maloberti, chief commercial officer, added, "The global pandemic is
not tempering the enthusiasm of clinicians for our TAEUS solution
to the growing NAFLD/NASH challenge, which impacts more than 1
billion people globally. We continue to make meaningful progress
toward our first TAEUS system sale.”
Financial Results for Quarter Ended September 30, 2020
●
Operating expenses increased to $3.3 million in
the third quarter of 2020, up from $2.6 million in the same period
in 2019. The increase was primarily due to expenses related to the
development of the TAEUS
product line, regulatory submissions, and costs associated
with TAEUS pre-commercialization
activities.
●
Net loss in the third quarter of
2020 was $3.3 million, or ($0.15) per share, compared with a net loss of $3.4 million, or ($0.46) per share,
in the third quarter of 2019.
●
The Company had
cash and cash equivalents of $3.8 million as of September 30, 2020, compared with
$6.2 million as of December 31, 2019, with no long-term
debt.
Conference Call and Webcast Access
Management will host a conference call and webcast today at 4:30
p.m. ET to discuss these 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: 38486
A telephone replay will be available from November 16, 2020 through
4:30 p.m. ET on November 23, 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 is the pioneer of Thermo Acoustic Enhanced
UltraSound (TAEUS), a ground-breaking technology being developed to
visualize tissue like MRI, but at 1/50th the cost and at the point
of patient care. TAEUS is designed to work in concert with the over
one million ultrasound systems in use globally today. TAEUS is
initially focused on the measurement of fat in the liver as a means
to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and
inflammation (NASH), chronic liver conditions that affect over one
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. For
more information, please visit www.endrainc.com. See
more. Do more. Live better®.
Forward-Looking Statements
All statements in this news 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
regarding commercializing the TAEUS device, establishing evaluation
reference sites and initial sales in Europe, receipt of U.S. Food
and Drug Administration regulatory approval, 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 and 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 news
release speak only as of the date of issuance, 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
Investor Relations Contact:
Kim Sutton Golodetz
LHA Investor Relations
(212) 838-3777
kgolodetz@lhai.com
ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets
|
September
30,
|
December
31,
|
Assets
|
2020
|
2019
|
Assets
|
(unaudited)
|
|
Cash
|
$3,793,292
|
$6,174,207
|
Prepaid
expenses
|
561,554
|
116,749
|
Inventory
|
323,208
|
113,442
|
Other current
assets
|
101,451
|
130,701
|
Total Current
Assets
|
4,779,505
|
6,535,099
|
Other
Assets
|
|
|
Fixed assets,
net
|
225,620
|
236,251
|
Right of use
assets
|
356,060
|
404,919
|
Total
Assets
|
$5,361,185
|
$7,176,269
|
|
|
|
Liabilities
and Stockholders’ Equity
|
|
|
Current
Liabilities
|
|
|
Accounts payable
and accrued liabilities
|
$1,325,005
|
$1,708,525
|
Convertible notes
payable, net of discount
|
-
|
298,069
|
Lease liabilities,
current portion
|
73,624
|
66,193
|
Total Current
Liabilities
|
1,398,629
|
2,072,787
|
|
|
|
Long
Term Debt
|
|
|
Loans
|
337,084
|
-
|
Lease
liabilities
|
290,489
|
342,812
|
Total Long Term
Debt
|
627,573
|
342,812
|
|
|
|
Total
Liabilities
|
2,026,202
|
2,415,599
|
|
|
|
Stockholders’
Equity
|
|
|
Series A
Convertible Preferred Stock, $0.0001 par value; 10,000 shares
authorized; 190 and 6,338 shares issued and outstanding,
respectively
|
1
|
1
|
Series B
Convertible Preferred Stock, $0.0001 par value; 1,000 shares
authorized; no shares and 352 shares issued and outstanding,
respectively
|
-
|
-
|
Common stock,
$0.0001 par value; 80,000,000 shares authorized; 25,015,710 and
8,421,401 shares issued and outstanding, respectively
|
2,500
|
842
|
Additional paid in
capital
|
58,281,673
|
49,933,736
|
Stock
payable
|
224,163
|
43,528
|
Stock
receivable
|
(85,626)
|
-
|
Accumulated
deficit
|
(55,087,728)
|
(45,217,437)
|
Total
Stockholders’ Equity
|
3,334,983
|
4,760,670
|
Total
Liabilities and Stockholders’ Equity
|
$5,361,185
|
$7,176,269
|
ENDRA Life Sciences Inc.
(Unaudited)
|
Three Months
Ended
|
Three Months
Ended
|
Nine Months
Ended
|
Nine Months
Ended
|
|
September
30,
|
September
30,
|
September
30,
|
September
30,
|
|
2020
|
2019
|
2020
|
2019
|
Operating
Expenses
|
|
|
|
|
Research and
development
|
$1,769,339
|
$1,468,441
|
$4,774,534
|
$4,546,746
|
Sales and
marketing
|
139,751
|
100,203
|
389,469
|
245,364
|
General and
administrative
|
1,346,360
|
1,071,889
|
4,083,572
|
2,920,815
|
Total operating
expenses
|
3,255,450
|
2,640,533
|
9,247,575
|
7,712,925
|
|
|
|
|
|
Operating
loss
|
(3,255,450)
|
(2,640,533)
|
(9,247,575)
|
(7,712,925)
|
|
|
|
|
|
Other
Expenses
|
|
|
|
|
Amortization of
debt discount
|
-
|
(728,417)
|
(232,426)
|
(728,417)
|
Other income
(expense)
|
(2,621)
|
(44,612)
|
5,261
|
(55,328)
|
Total other
expenses
|
(2,621)
|
(773,029)
|
(227,165)
|
(783,745)
|
|
|
|
|
|
Loss from
operations before income taxes
|
(3,258,071)
|
(3,413,562)
|
(9,474,740)
|
(8,496,670)
|
|
|
|
|
|
Provision for
income taxes
|
-
|
-
|
-
|
-
|
|
|
|
|
|
Net
Loss
|
$(3,258,071)
|
$(3,413,562)
|
$(9,474,740)
|
$(8,496,670)
|
|
|
|
|
|
Deemed
dividend
|
(395,551)
|
-
|
(395,551)
|
-
|
|
|
|
|
|
Net
Loss attributable to common stockholders
|
$(3,653,622)
|
$(3,413,562)
|
$(9,870,291)
|
$(8,496,670)
|
|
|
|
|
|
Net
loss per share – basic and diluted
|
$(0.15)
|
$(0.46)
|
$(0.41)
|
$(1.14)
|
|
|
|
|
|
Weighted
average common shares – basic and diluted
|
23,889,591
|
7,428,788
|
23,808,012
|
7,424,713
|
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
Nine Months Ended
|
Nine Months Ended
|
|
September 30,
|
September 30,
|
|
2020
|
2019
|
Cash
Flows from Operating Activities
|
|
|
Net
loss
|
$(9,474,740)
|
$(8,496,670)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation and
amortization
|
45,114
|
59,673
|
Common stock,
options and warrants issued for services
|
1,559,232
|
1,020,300
|
Amortization of
debt discount
|
232,426
|
728,417
|
Amortization of
right of use assets
|
48,859
|
-
|
Stock payable for
investor relations
|
30,000
|
-
|
Changes in
operating assets and liabilities:
|
|
|
Increase in prepaid
expenses
|
(444,805)
|
(61,234)
|
Decrease in lease
liability
|
(44,892)
|
-
|
Increase in
inventory
|
(209,766)
|
(68,387)
|
Decrease (increase)
in other asset
|
29,250
|
(93,075)
|
(Decrease) increase
in accounts payable and accrued liabilities
|
(444,167)
|
229,640
|
Net cash used in
operating activities
|
(8,673,489)
|
(6,681,336)
|
|
|
|
Cash
Flows from Investing Activities
|
|
|
Purchases of fixed
assets
|
(10,483)
|
(5,238)
|
Net cash used in
investing activities
|
(10,483)
|
(5,238)
|
|
|
|
Cash
Flows from Financing Activities
|
|
|
Proceeds from
senior secured convertible promissory notes, net of
fees
|
-
|
2,490,501
|
Proceeds from
warrant exercise
|
4,644,084
|
-
|
Proceeds from
loans
|
337,084
|
-
|
Proceeds from
issuance of common stock
|
1,321,890
|
-
|
Net cash provided
by financing activities
|
6,303,058
|
2,490,501
|
|
|
|
Net decrease in
cash
|
(2,380,914)
|
(4,196,073)
|
|
|
|
Cash, beginning of
period
|
6,174,207
|
6,471,375
|
|
|
|
Cash,
end of period
|
$3,793,293
|
$2,275,302
|
|
|
|
Supplemental
disclosures of cash items
|
|
|
Interest
paid
|
$1,920
|
$-
|
Income tax
paid
|
$-
|
$-
|
|
|
|
Supplemental
disclosures of non-cash items
|
|
|
Discount on
convertible notes
|
$-
|
$2,490,501
|
Conversion of
convertible notes and accrued interest
|
$493,814
|
$140,405
|
Deemed dividend
related to warrant repriced
|
$395,551
|
|
Conversion of
Series A Convertible Preferred Stock
|
$(717)
|
$-
|
Conversion of
Series B Convertible Preferred Stock
|
$(36)
|
$-
|
Stock dividend
payable
|
$(47,641)
|
$-
|
Right of use
asset
|
$356,060
|
$(420,488)
|
Lease
liability
|
$364,113
|
$424,210
|