Conference call begins at 4:30 p.m. Eastern
time today
ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo
Acoustic Enhanced UltraSound (TAEUS®), today reported financial
results for the three months and year ended December 31, 2021 and
provided a business update. Highlights of the fourth quarter of
2021 and recent weeks include:
- Achieved clarity on the U.S. regulatory strategy for the
TAEUS system. After extensive and productive dialogue with the
U.S. Food and Drug Administration (FDA), ENDRA is now pursuing the
De Novo pathway for its TAEUS System, which is intended to
characterize fatty liver tissue as a non-invasive means to assess
and monitor Non-Alcoholic Fatty Liver Disease (NAFLD). The De Novo
request will build upon ENDRA's completed 510(k) submission and the
pathway provides ENDRA with the opportunity to set the bar for an
entirely new product classification, which should yield important
and sustainable commercial advantages for the TAEUS platform. The
company intends to include clinical data from a subset of its
existing global clinical research partnerships to satisfy the data
requirements for the De Novo request as rapidly as possible.
- Expanded into China with an eighth clinical study
partner. ENDRA’s latest research partnership, with China’s
renowned Shanghai General Hospital (Shanghai First People’s
Hospital Affiliated with Shanghai Jiao Tong University), further
validates ENDRA’s technology and provides a strategic entry point
into China’s healthcare market, which seeks to deliver
cost-effective services to 1.4 billion citizens including an
estimated 350 million people with NAFLD and Non-Alcoholic
Steatohepatitis (NASH).
- Secured an additional European clinical study partnership
with King’s College Hospital in London. This is ENDRA’s fourth
clinical research partnership in Europe. Data from the King’s
College Hospital study, along with other ongoing or to-be-initiated
studies, will be used to bolster clinical evidence and further
establish the clinical utility of the TAEUS device for assessing
NAFLD-NASH.
- Partnered with VGI Health Technology (VGI) to support its
upcoming Phase 2 study of its NAFLD-NASH drug candidate. ENDRA
signed a collaboration agreement with VGI to incorporate TAEUS as
an add-on technology to support VGI’s patient screening and
biomarker measurement during its planned Phase 2 study of IVB001 in
patients with NAFLD-NASH.
- Strengthened TAEUS intellectual property (IP) protection
with the issuance of four U.S., two European and two Chinese
patents. The company was issued four U.S. patents that further
protect its optimized hybrid ultrasound and thermoacoustic imaging
systems for a wide range of applications, bringing the total number
of U.S. patents to 24. ENDRA was also issued two European patents
and two Chinese patents that broaden and expand its global IP
portfolio. ENDRA’s global IP portfolio now stands at 89 assets,
defined as patents in preparation, filed or issued.
- Achieved key Quality Management System certification.
ENDRA received its Medical Device Quality Management System ISO
13485:2016 recertification, which affirms its quality standards
supporting the TAEUS system’s CE mark. It further demonstrates the
company’s commitment to uphold the highest quality product
development and manufacture of the TAEUS System to meet customer
and international regulatory standards.
- Balance sheet supports ongoing commercial activities. As
of December 31, 2021, ENDRA had cash and cash equivalents of $9.5
million. Together with availability under its at-the-market
offering program, the company believes it is sufficiently
capitalized to advance its commercial activities in Europe and to
support its clinical research partners worldwide.
“We are pleased to have advanced our operating plan in 2021 and
into 2022 under challenging global market conditions facing a
resurgence of COVID-19 during that time. ENDRA actively increased
commercial awareness for TAEUS through participation in seven
global clinical conferences and more than 150 in-person and virtual
product demonstrations in Europe. We enlarged the offensive and
defensive scope of our IP portfolio to 89 assets, signed new
clinical collaborations with leading healthcare institutions and
pharmaceutical partners in the U.K., China and Australia and
achieved clarity on our U.S regulatory path for the TAEUS liver
platform," stated Francois Michelon, Chairman and Chief Executive
Officer of ENDRA. “In 2022, as healthcare operations improve, we
are laser-focused on ramping up our remaining global clinical
research sites to generate data to support commercialization and
converting our pipeline of European sales opportunities to
revenue."
Fourth Quarter 2021 Financial Results
- Operating expenses increased to $3.1 million in the fourth
quarter of 2021 from $2.3 million in the same period in 2020. The
increase was primarily due to higher headcount and regulatory
expenses.
- Net loss in the fourth quarter of 2021 was $3.1 million, or
$0.07 per share, compared with a net loss of $2.3 million, or $0.08
per share, in the fourth quarter of 2020.
Full Year 2021 Financial Results
- Operating expenses were $11.5 million in 2021, unchanged from
2020. Increases in sales and marketing expenses were offset by
decreases in research and development and general and
administrative expenses.
- Net loss in 2021 was $11.2 million, or $0.28 per share,
compared with a net loss of $11.7 million, or $0.63 per share, in
2020.
- Cash and cash equivalents were $9.5 million as of December 31,
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. Those unable to pre-register may
participate by dialing (866) 777-2509 (U.S.) or (412) 317-5413
(International). A webcast of the call may also be accessed at
ENDRA’s Investor Relations page and here.
A telephone replay will be available until April 6, 2022 by
dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and
providing the passcode 8208803. A webcast replay will be available
beginning approximately one hour after the completion of the live
conference call here.
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 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 terms such as “approximate,” "anticipate," “attempt,” "believe,"
"could," "estimate," "expect," “future,” "goal," "intend," "may,"
"plan," “possible,” “potential,” "seek," "should," "will," or other
comparable terms (including the negative of any of the foregoing),
although some forward-looking statements are expressed differently.
Examples of forward-looking statements for ENDRA include, among
others, estimates of the timing of future events and anticipated
results of our development efforts, including the timing for
receipt of required regulatory approvals and product launches,
expectations concerning ENDRA's business strategy, ENDRA’s ability
to find and maintain development partners, market acceptance of its
technology and the amount and nature of competition in its
industry, and its ability to protect its intellectual property.
Forward-looking statements involve inherent risks and uncertainties
that could cause actual results to differ materially from those in
the forward-looking statements as a result of various factors
including, among others, ENDRA’s ability to develop a commercially
feasible technology and its dependence on third parties to design
and manufacture its products; receipt of necessary regulatory
approvals; the impact of COVID-19 on ENDRA’s business plans;
ENDRA’s ability to find and maintain development partners, market
acceptance of ENDRA’s technology and the amount and nature of
competition in its industry; ENDRA’s ability to protect its
intellectual property; and the other risks and uncertainties
described in the Risk Factors and Management’s Discussion and
Analysis of Financial Condition and Results of Operations sections
of the Company’s most recent Annual Report on Form 10-K and in
subsequently filed Quarterly Reports on Form 10-Q filed with the
Securities and Exchange Commission. You should not rely upon
forward-looking statements as predictions of future events. 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.
[Financial Tables Follow]
ENDRA Life Sciences
Inc.
Consolidated Balance
Sheets
December 31,
December 31,
Assets
2021
2020
Current Assets
Cash
$
9,461,534
$
7,227,316
Prepaid expenses
1,348,003
390,800
Inventory
1,284,578
589,620
Total Current Assets
12,094,115
8,207,736
Non-Current Assets
Fixed assets, net
131,130
212,242
Right of use assets
643,413
339,012
Other assets
5,986
5,986
Total Assets
$
12,874,644
$
8,764,976
Liabilities and Stockholders’
Equity
Current Liabilities
Accounts payable and accrued
liabilities
$
1,411,437
$
910,183
Lease liabilities, current portion
132,330
76,480
Total Current Liabilities
1,543,767
986,663
Long Term Debt
Loans
28,484
337,084
Lease liabilities
518,147
271,908
Total Long Term Debt
546,631
608,992
Total Liabilities
2,090,398
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; 42,554,514 and 34,049,704 shares
issued and outstanding, respectively
4,254
3,404
Additional paid in capital
79,456,938
64,493,611
Stock payable
13,863
10,794
Accumulated deficit
(68,690,810
)
(57,338,489
)
Total Stockholders’ Equity
10,784,246
7,169,321
Total Liabilities and Stockholders’
Equity
$
12,874,644
$
8,764,976
ENDRA Life Sciences
Inc.
Consolidated Statements of
Operations
Year Ended
Year Ended
December 31,
December 31,
2021
2020
Operating Expenses
Research and development
$
5,482,531
$
5,917,944
Sales and marketing
1,075,376
581,893
General and administrative
4,940,398
5,002,080
Total operating expenses
11,498,305
11,501,917
Operating loss
(11,498,305
)
(11,501,917
)
Other Expenses
Amortization of debt discount
-
(232,426
)
Gain on extinguishment of debt
308,600
-
Other income (expense)
(41,545
)
8,842
Total other expenses
267,055
(223,584
)
Loss from operations before income
taxes
(11,231,250
)
(11,725,501
)
Provision for income taxes
-
-
Net Loss
$
(11,231,250
)
$
(11,725,501
)
Deemed dividend
(121,071
)
(395,551
)
Net Loss attributable to common
stockholders
$
(11,352,321
)
$
(12,121,052
)
Net loss per share – basic and
diluted
$
(0.28
)
$
(0.63
)
Weighted average common shares – basic
and diluted
40,922,709
19,192,226
ENDRA Life Sciences
Inc.
Consolidated Statements of
Cash Flows
Year Ended
Year Ended
December 31,
December 31,
2021
2020
Cash Flows from Operating
Activities
Net loss
$
(11,231,250
)
$
(11,725,501
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization
116,238
99,342
Fixed assets write off
9,874
-
Stock compensation expense including
common stock issued for RSUs
1,444,572
2,102,352
Amortization of debt discount
-
232,426
Amortization of right of use assets
108,177
65,907
Gain on extinguishment of debt
(308,600
)
-
Changes in operating assets and
liabilities:
Increase in prepaid expenses
(957,203
)
(274,051
)
Increase in inventory
(694,958
)
(476,178
)
Decrease in other current asset
-
124,715
Increase in accounts payable and accrued
liabilities
491,104
(834,990
)
Increase in lease liability
(100,338
)
(60,617
)
Net cash used in operating activities
(11,122,384
)
(10,746,595
)
Cash Flows from Investing
Activities
Purchases of fixed assets
(45,000
)
(75,333
)
Net cash used in investing activities
(45,000
)
(75,333
)
Cash Flows from Financing
Activities
Proceeds from warrant exercise
2,785,627
4,757,011
Proceeds from loans
-
337,084
Proceeds from issuance of common stock
10,615,975
6,780,942
Net cash provided by financing
activities
13,401,602
11,875,037
Net increase in cash
2,234,218
1,053,109
Cash, beginning of year
7,227,316
6,174,207
Cash, end of year
$
9,461,534
$
7,227,316
Supplemental disclosures of cash items
Interest paid
$
57,655
$
1,920
Income tax paid
$
-
$
-
Supplemental disclosures of non-cash
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 issued for financing cost
$
-
$
27,300
Stock dividend payable
$
(3,067
)
$
(49,649
)
Right of use asset
$
643,413
$
339,012
Lease liability
$
650,477
$
348,388
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220330005767/en/
Company Contact: Irina Pestrikova Senior Director,
Finance investors@endrainc.com www.endrainc.com
Investor Relations Contact: Yvonne Briggs LHA Investor
Relations (310) 691-7100 ybriggs@lhai.com
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