Conference call begins at 4:30 p.m. Eastern
time today
ENDRA Life Sciences Inc. (ENDRA) (NASDAQ: NDRA), a pioneer of
Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported
financial results for the three months ended September 30, 2021 and
provided a business update. Highlights of the third quarter of 2021
and recent weeks include:
- Patient screening was initiated at the University of
Pittsburgh Medical Center (UPMC) while it continues to work
through a pandemic-related backlog of MRI procedures. Both the UPMC
study and the Rocky Vista University College of Osteopathic
Medicine (RVUCOM) study, which started scanning patients earlier
this year, are comparing liver fat measurements from the TAEUS
system to the gold standard, MRI-PDFF. RVUCOM’s study is targeting
a total of 200 patients and UPMC’s is targeting 75 patients.
- In-person commercial activities increased for the TAEUS
system in Europe, despite recent COVID-19 trends. ENDRA’s sales
team is conducting in-person sales visits, including group
demonstrations, building a robust pipeline of customer leads. In
addition, ENDRA participated in trade shows in France with the
ability to demonstrate in-person the benefits of the TAEUS
system.
- TAEUS intellectual property (IP) protection bolstered with
issuance of 21st U.S. patent. A U.S. patent was issued in
October relating to a novel method and system for monitoring tissue
temperature during surgical procedures using the TAEUS system. This
adds to three U.S. patents issued in July, representing further
protection of optimized hybrid ultrasound and thermoacoustic
imaging systems for a wide range of applications. ENDRA’s current
IP portfolio stands at 89 assets, which the company defines as
patents in preparation, filed or issued.
- Strong balance sheet supports commercial activities in
Europe. As of September 30, 2021, ENDRA had cash and cash
equivalents of $11.8 million. The company is well-capitalized to
continue building its commercial efforts in Europe and to support
its clinical evaluation partners worldwide, as it awaits a
regulatory determination in the U.S.
“In parallel with advancing our commercial plan in Europe, we
continue to engage actively with the FDA regarding the TAEUS
system’s 510(k) submission. We are working collaboratively with the
Agency for agreement on a definitive path forward, including
potentially providing additional real-world clinical data, as the
review period has taken longer than we expected,” stated Francois
Michelon, Chairman and Chief Executive Officer of ENDRA.
“Despite a recent uptick in COVID-19 cases in Europe, our sales
team has been able to schedule in-person visits and to facilitate
group demonstrations. In addition, we have been able to participate
in trade shows in-person, resulting in additional sales leads to
expand our customer database,” commented Renaud Maloberti, ENDRA’s
Chief Commercial Officer.
Third Quarter 2021 Financial Results
- Operating expenses decreased to $2.7 million in the third
quarter of 2021 from $3.3 million in the same period in 2020. The
decrease was primarily due to reduced spending for product
development and investor relations.
- Net loss in the third quarter of 2021 was $2.7 million, or
$0.06 per share, compared with a net loss of $3.3 million, or $0.15
per share, in the third quarter of 2020.
- Cash and cash equivalents were $11.8 million as of September
30, 2021.
Conference Call and Webcast
Management will host a conference call and webcast today at 4:30
p.m. Eastern time to discuss these results, provide an update on
recent corporate developments and answer questions.
Participants are encouraged to pre-register for the conference
call using this link. Callers who pre-register will be given a
unique PIN to gain immediate access to the call and bypass the live
operator. Participants may register at any time, including up to
and after the call start time. A webcast of the call may also be
accessed at ENDRA’s Investor Relations page and here. Those without
internet access or unable to pre-register should dial (866)
777-2509 (U.S.) or (412) 317-5413 (International).
A replay of the webcast will be available beginning
approximately one hour after the completion of the live conference
call here. A replay of the call will be available until November
22, 2021 by dialing (877) 344-7529 (U.S.) or (412) 317-0088
(International) and providing the passcode 10161144.
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
400,000 cart-based 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 Non-Alcoholic Steatohepatitis (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.
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 regarding
milestones and future sales, 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.
[Financial Tables Follow]
ENDRA Life Sciences
Inc.
Condensed Consolidated Balance
Sheets
September 30,
2021
December 31,
2020
(Unaudited)
Assets
Current Assets
Cash
$
11,793,189
$
7,227,316
Prepaid expenses
1,177,201
390,800
Inventory
1,499,743
589,620
Total Current Assets
14,470,133
8,207,736
Non-Current Assets
Fixed assets, net
162,265
212,242
Right of use assets
675,822
339,012
Other assets
5,986
5,986
Total Assets
$
15,314,206
$
8,764,976
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable and accrued
liabilities
$
1,449,130
$
910,183
Lease liabilities, current portion
127,696
76,480
Total Current Liabilities
1,576,826
986,663
Long Term Debt
Loans
28,484
337,084
Lease liabilities
552,830
271,908
Total Long Term Debt
581,314
608,992
Total Liabilities
2,158,140
1,595,655
Stockholders’ Equity
Series A Convertible Preferred Stock,
$0.0001 par value; 10,000 shares authorized; 141.397 and 190.288
shares issued and outstanding, respectively
1
1
Series B Convertible Preferred Stock,
$0.0001 par value; 1,000 shares authorized; no shares issued and
outstanding
-
-
Common stock, $0.0001 par value;
80,000,000 shares authorized; 42,165,726 and 34,049,704 shares
issued and outstanding, respectively
4,215
3,404
Additional paid in capital
78,695,367
64,493,611
Stock payable
42,665
10,794
Accumulated deficit
(65,586,182
)
(57,338,489
)
Total Stockholders’ Equity
13,156,066
7,169,321
Total Liabilities and Stockholders’
Equity
$
15,314,206
$
8,764,976
ENDRA Life Sciences
Inc.
Condensed Consolidated
Statements of Operations
(Unaudited)
Three Months
Ended
September 30,
Three Months
Ended
September 30,
Nine Months
Ended
September 30,
Nine Months
Ended
September 30,
2021
2020
2021
2020
Operating Expenses
Research and development
$
1,173,319
$
1,769,339
$
4,059,730
$
4,774,534
Sales and marketing
275,565
139,751
693,263
389,469
General and administrative
1,201,851
1,346,360
3,673,771
4,083,572
Total operating expenses
2,650,735
3,255,450
8,426,764
9,247,575
Operating loss
(2,650,735
)
(3,255,450
)
(8,426,764
)
(9,247,575
)
Other Expenses
Amortization of debt discount
-
-
-
(232,426
)
Gain on extinguishment of debt
-
-
308,600
-
Other income (expense)
(7,507
)
(2,621
)
(8,458
)
5,261
Total other expenses
(7,507
)
(2,621
)
300,142
(227,165
)
Loss from operations before income
taxes
(2,658,242
)
(3,258,071
)
(8,126,622
)
(9,474,740
)
Provision for income taxes
-
-
-
-
Net Loss
$
(2,658,242
)
$
(3,258,071
)
$
(8,126,622
)
$
(9,474,740
)
Deemed dividend
-
(395,551
)
(121,071
)
(395,551
)
Net loss attributable to common
stockholders
$
(2,658,242
)
$
(3,653,622
)
$
(8,247,693
)
$
(9,870,291
)
Net loss per share – basic and
diluted
$
(0.06
)
$
(0.15
)
$
(0.20
)
$
(0.41
)
Weighted average common shares – basic
and diluted
41,912,535
23,889,591
40,471,906
23,808,012
ENDRA Life Sciences
Inc.
Condensed Consolidated
Statements of Cash Flows
(Unaudited)
Nine Months
Ended
September 30,
2021
Nine Months
Ended
September 30,
2020
Cash Flows from Operating
Activities
Net loss
$
(8,126,622
)
$
(9,474,740
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization
94,977
45,114
Stock compensation expense including
common stock issued for RSUs
1,032,835
1,559,232
Amortization of debt discount
-
232,426
Amortization of right of use assets
75,768
48,859
Gain on extinguishment of debt
(308,600
)
-
Stock payable for investor relations
-
30,000
Changes in operating assets and
liabilities:
Increase in prepaid expenses
(786,401
)
(444,805
)
Increase in inventory
(910,123
)
(209,766
)
Decrease in other asset
-
29,250
Increase(decrease) in accounts payable and
accrued liabilities
528,797
(444,167
)
Decrease in lease liability
(70,289
)
(44,892
)
Net cash used in operating activities
(8,469,653
)
(8,673,489
)
Cash Flows from Investing
Activities
Purchases of fixed assets
(45,000
)
(10,483
)
Net cash used in investing activities
(45,000
)
(10,483
)
Cash Flows from Financing
Activities
Proceeds from warrant exercise
2,785,627
4,644,084
Proceeds from loans
-
337,084
Proceeds from issuance of common stock
10,294,899
1,321,890
Net cash provided by financing
activities
13,080,526
6,303,058
Net increase (decrease) in cash
4,565,875
(2,380,914
)
Cash, beginning of period
7,227,316
6,174,207
Cash, end of period
$
11,793,189
$
3,793,293
Supplemental disclosures of cash items
Interest paid
$
40,887
$
1,920
Income tax paid
$
-
-
Supplemental disclosures of noncash
items
Conversion of convertible notes and
accrued interest
$
-
$
493,814
Exchange of balance in convertible notes
and accrued interest for Series A preferred stock
$
-
$
-
Deemed dividend
$
121,071
$
395,551
Conversion of Series A Convertible
Preferred Stock
$
(7
)
$
(717
)
Conversion of Series B Convertible
Preferred Stock
$
-
$
(36
)
Stock dividend payable
$
(31,870
)
$
(47,641
)
Stock issued for RSU
$
36,462
$
-
Right of use asset
$
675,822
$
356,060
Lease liability
$
680,526
$
364,113
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211115006176/en/
Company: Irina Pestrikova Senior Director, Finance
investors@endrainc.com www.endrainc.com
Investor Relations: Yvonne Briggs LHA Investor Relations
(310) 691-7100 ybriggs@lhai.com
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