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 ended March 31, 2022, and provided a
business update. Highlights of the first quarter of 2022 and recent
weeks include:
- Raised $8.7 million in gross proceeds, extending cash
runway. The company raised a total of $8.7 million in gross
proceeds year-to-date from the sale of common stock through its
at-the-market (ATM) equity facility, of which $7.8 million was
raised subsequent to the close of the first quarter. With this
bolstered cash position, management believes ENDRA is capitalized
to fund operations through several important milestones, including
ramping-up commercial activities in Europe and advancing the TAEUS
system through the regulatory process in the U.S.
- Reached clarity on the U.S. regulatory strategy for the
TAEUS system and on track to submit De Novo request in the third
quarter. After extensive and productive dialogue with the U.S.
Food and Drug Administration (FDA), ENDRA is pursuing the De Novo
pathway for its TAEUS Liver 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
pathway will build upon ENDRA's completed 510(k) application and
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 novel TAEUS platform.
Under the De Novo process, the company intends to provide
smaller-scale TAEUS human study data, which will come from ENDRA's
existing clinical study sites and is not expected to add material
expenses to ENDRA.
- 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 interest in 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).
- Grew global intellectual property (IP) portfolio to 90
assets, including 46 issued patents. The company was issued
five U.S. patents, two European patents and four Chinese patents
that further protect its optimized hybrid ultrasound and
thermoacoustic imaging systems for a wide range of applications. In
addition, one of the newly issued U.S. patents related to the
transfer of data from a device not connected to the internet
expands potential licensing opportunities for the company.
- Achieved key Quality Management System certification.
ENDRA received 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 development and
manufacture of the TAEUS System to meet customer and international
regulatory standards.
“We significantly strengthened our balance sheet during the
challenging macro environment with the use of our ATM facility to
ensure we are well-capitalized to fund the ramp-up in our sales and
marketing activities in Europe and our regulatory process in the
U.S.," stated Francois Michelon, Chairman and Chief Executive
Officer of ENDRA. “Central to these goals, we are advancing our
clinical research sites to generate data to support the
commercialization of our TAEUS system and the submission of our De
Novo request. To date, approximately 40 patients have been scanned
in the U.S., and we recently activated a new research site in
Germany to contribute clinical data and help ENDRA evaluate new
product features. With these advancements, as well as the
activation of our remaining clinical sites in Europe, the U.S and
Asia in the coming months, we are confident in achieving our goal
of scanning over 200 patients by year-end."
First Quarter 2022 Financial Results
- Operating expenses increased to $2.9 million in the first
quarter of 2022 from $2.6 million in the same period in 2021. The
increase was primarily due to increased spending for
commercialization of TAEUS and ongoing product development.
- Net loss in the first quarter of 2022 was $2.9 million, or
$0.07 per share, compared with a net loss of $2.3 million, or $0.06
per share, in the first quarter of 2021.
- Cash and cash equivalents were $7.1 million as of March 31,
2022; as noted above, $7.8 million was raised subsequent to the
close of the first quarter through the company’s ATM facility.
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 (844) 868-8846 (U.S.) or (412) 317-5465
(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 May 19, 2022 by
dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and
providing the passcode 6511486. 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 press 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," “forecast,” “future,” "goal,"
“hope,” "intend," "may," "plan," “possible,” “potential,”
“project,” "seek," "should," "will," “would,” 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; future
financial position and projected costs and revenue; expectations
concerning ENDRA's business strategy; 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; and ENDRA’s 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: the ability to raise additional capital in
order to continue as a going concern; the ability to obtain
regulatory approvals necessary to sell ENDRA medical devices in
certain markets in a timely manner, or at all; the ability to
develop a commercially feasible technology and its dependence on
third parties to design and manufacture its products; the impact of
COVID-19 on ENDRA’s business plans; the 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 subsequent 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 press 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
March 31,
December 31,
Assets
2022
2021
Current Assets
(Unaudited)
Cash
$
7,127,363
$
9,461,534
Prepaid expenses
1,061,406
1,348,003
Inventory
1,930,258
1,284,578
Total Current Assets
10,119,027
12,094,115
Non-Current Assets
Fixed assets, net
201,445
131,130
Right of use assets
610,234
643,413
Other assets
5,986
5,986
Total Assets
$
10,936,692
$
12,874,644
Liabilities
and Stockholders’ Equity
Current Liabilities
Accounts payable and accrued
liabilities
$
1,220,840
$
1,411,437
Lease liabilities, current portion
137,117
132,330
Total Current Liabilities
1,357,957
1,543,767
Long Term Debt
Loans
28,484
28,484
Lease liabilities
481,618
518,147
Total Long Term Debt
510,102
546,631
Total Liabilities
1,868,059
2,090,398
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; 44,559,418 and 42,554,514 shares
issued and outstanding, respectively
4,454
4,254
Additional paid in capital
80,604,416
79,456,938
Stock payable
8,774
13,863
Accumulated deficit
(71,549,012
)
(68,690,810
)
Total Stockholders’ Equity
9,068,633
10,784,246
Total Liabilities and Stockholders’
Equity
$
10,936,692
$
12,874,644
ENDRA Life Sciences
Inc.
Consolidated Statements of
Operations
(Unaudited)
Three Months Ended
Three Months Ended
March 31,
March 31,
2022
2021
Operating Expenses
Research and development
$
1,213,022
$
1,141,486
Sales and marketing
339,903
160,935
General and administrative
1,302,344
1,273,418
Total operating expenses
2,855,269
2,575,839
Operating loss
(2,855,269
)
(2,575,839
)
Other Expenses
Gain on extinguishment of debt
-
308,600
Other expense
(2,933
)
(2,037
)
Total other (expenses)
(2,933
)
306,563
Loss from operations before income
taxes
(2,858,202
)
(2,269,276
)
Provision for income taxes
-
-
Net Loss
$
(2,858,202
)
$
(2,269,276
)
Deemed dividend
-
(121,071
)
Net Loss attributable to common
stockholders
$
(2,858,202
)
$
(2,390,347
)
Net loss per share – basic and diluted
$
(0.07
)
$
(0.06
)
Weighted average common shares – basic and
diluted
43,054,224
37,772,515
ENDRA Life Sciences
Inc.
Condensed Consolidated
Statements of Cash Flows
(Unaudited)
Three Months Ended
Three Months Ended
March 31,
March 31,
2022
2021
Cash Flows from Operating Activities
Net loss
$
(2,858,202
)
$
(2,269,276
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization
19,038
31,425
Stock compensation expense including
common stock issued for RSUs
288,537
321,949
Stock payable for investor relations
-
46,250
Amortization of right of use assets
33,179
17,449
Gain on extinguishment of debt
-
(308,600
)
Changes in operating assets and
liabilities:
Decrease in prepaid expenses
286,597
(385,292
)
Increase in inventory
(645,680
)
(136,988
)
Decrease in accounts payable and accrued
liabilities
(190,597
)
(223,532
)
Decrease in lease liability
(31,742
)
(16,868
)
Net cash used in operating activities
(3,098,870
)
(2,923,483
)
Cash Flows from Investing Activities
Purchases of fixed assets
(89,353
)
(45,000
)
Net cash used in investing activities
(89,353
)
(45,000
)
Cash Flows from Financing Activities
Proceeds from warrant exercise
-
2,785,627
Proceeds from issuance of common stock
854,052
9,798,293
Net cash provided by financing
activities
854,052
12,583,920
Net increase (decrease) in cash
(2,334,171
)
9,615,437
Cash, beginning of period
9,461,534
7,227,316
Cash, end of period
$
7,127,363
$
16,842,753
Supplemental disclosures of cash items
Interest paid
$
-
$
-
Income tax paid
$
-
$
-
Supplemental disclosures of non-cash
items
Deemed dividend
$
-
$
121,071
Conversion of Series A Convertible
Preferred Stock
$
-
$
(7
)
Stock dividend payable
$
5,089
$
(22,337
)
Right of use asset
$
610,234
$
321,563
Lease liability
$
618,735
$
331,520
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220512005988/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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