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 and six months ended June 30, 2023 and
provided a business update. Highlights from the second quarter of
2023 and recent weeks include:
- Submitted a De Novo Request to the U.S. Food and Drug
Administration (FDA) for the TAEUS liver system. The TAEUS
system is ENDRA’s proprietary device that is intended to offer
clinicians a tool for the non-invasive assessment of fatty liver
tissue, as an aid in the management of patients with Non-Alcoholic
Fatty Liver Disease (NAFLD). The submission included patient scans
from established clinical study sites comparing TAEUS liver fat
fraction estimates to MRI-PDFF (Magnetic Resonance Imaging Proton
Density Fat Fraction), which is the gold standard for clinical
measurement of liver fat fraction. The study data yielded a
sensitivity of 90%. TAEUS estimates of liver fat fraction were
strongly correlated to MRI-PDFF scores with a Pearson correlation
coefficient of r=0.78.
- Showcased the TAEUS liver system's capabilities at two
European clinical conferences. ENDRA participated in the German
Diabetes Association’s 57th DDG Annual Meeting in Berlin, which
underscored the role of liver health in managing type 2 diabetes.
Additionally, the company shared study findings in a peer-reviewed
clinical abstract titled "Thermoacoustic assessment of fatty liver
disease - an early clinical feasibility study” at the esteemed
European Association for the Study of the Liver (EASL) Congress in
Vienna. This presentation served to elevate TAEUS' profile among
potential clinical users to support commercial adoption.
- Continued the expansion of its intellectual property
portfolio to 64 issued patents globally. During the second
quarter, ENDRA secured four additional patents, including one in
the U.S. and three in China. These newly issued patents not only
reinforce ENDRA's unique position in assessing liver fat, but also
open the doors for other potential applications. The company is
actively exploring licensing opportunities in non-core indications
to augment the value of its growing IP portfolio.
- Raised approximately $4.7 million and extended the cash
runway. In May, the company raised approximately $4.7 million
in net proceeds from the sale of common stock and warrants in a
public offering. Management believes ENDRA has sufficient cash to
fund operations through several important milestones expected in
2023, including supporting commercial activities in Europe.
"Our De Novo submission for the TAEUS system marks a pivotal
milestone for ENDRA. It's the culmination of remarkable commitment
by the ENDRA team and our clinical partners to address a
significant unmet clinical need by providing a non-invasive tool to
assess liver fat, at a fraction of the cost of MRI. We believe the
De Novo process holds the potential to set the regulatory bar for
an entirely new product classification, showcasing TAEUS' unique
and innovative capabilities," said Francois Michelon, Chairman and
Chief Executive Officer of ENDRA. "We believe our submission is
robust and we look forward to working with the FDA as they proceed
with their review.”
Second Quarter 2023 Financial Results
Operating expenses in the second quarter of 2023 were $3.0
million, compared with $3.6 million in the second quarter in 2022.
The decrease was mainly due to a decrease in research and
development and sales and marketing expenses.
Net loss in the second quarter of 2023 was $2.6 million, or
$0.43 per share, compared with a net loss of $3.6 million, or $1.17
per share, in the second quarter of 2022.
Cash and cash equivalents were $4.8 million as of June 30, 2023.
In May, the company raised approximately $4.7 million in net
proceeds through an underwritten public offering.
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 receive 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 can also be accessed at
ENDRA’s Investor Relations page and here.
A telephone replay will be available until August 21, 2023 by
dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and
providing the passcode 3299822. 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
the more than 700,000 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 of submission for and
receipt of required regulatory approvals and product launches;
statements relating to future financial position and projected
costs and revenue; expectations concerning ENDRA's business
strategy; and statements regarding ENDRA’s ability to find and
maintain development partners. 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
June 30,
December 31,
Assets
2023
2022
Current Assets
(Unaudited)
Cash
$
4,819,459
$
4,889,098
Prepaid expenses
506,914
490,299
Inventory
2,757,633
2,644,717
Total Current Assets
8,084,006
8,024,114
Non-Current Assets
Fixed assets, net
192,874
235,655
Right of use assets
431,842
505,816
Prepaid expenses, long term
530,068
502,576
Other assets
5,986
5,986
Total Assets
$
9,244,776
$
9,274,147
Liabilities and Stockholders’
Equity
Current Liabilities
Accounts payable and accrued
liabilities
$
1,841,562
$
1,523,012
Lease liabilities, current portion
163,013
152,228
Loans
28,484
28,484
Total Current Liabilities
2,033,059
1,703,724
Long Term Debt
Lease liabilities
281,154
365,919
Total Long Term Debt
281,154
365,919
Total Liabilities
2,314,213
2,069,643
Stockholders’ Equity
Series A Convertible Preferred Stock,
$0.0001 par value; 10,000 shares authorized; 141.397 shares issued
and outstanding
1
1
Series B Convertible Preferred Stock,
$0.0001 par value; 1,000 shares authorized; no shares issued and
outstanding
-
-
Series C Convertible Preferred Stock,
$0.0001 par value; 100,000 shares authorized; no shares issued and
outstanding
-
-
Common stock, $0.0001 par value;
80,000,000 shares authorized; 7,481,603 and 3,169,103 shares issued
and outstanding, respectively
748
317
Additional paid in capital
94,297,167
89,068,015
Stock payable
2,427
6,073
Accumulated deficit
(87,369,780
)
(81,869,902
)
Total Stockholders’ Equity
6,930,563
7,204,504
Total Liabilities and Stockholders’
Equity
$
9,244,776
$
9,274,147
ENDRA Life Sciences Inc.
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,
2023
2022
2023
2022
Operating Expenses
Research and development
$
1,400,182
$
1,847,560
$
2,791,496
$
3,060,582
Sales and marketing
247,773
342,039
429,389
681,942
General and administrative
1,346,610
1,382,094
2,713,008
2,684,438
Total operating expenses
2,994,565
3,571,693
5,933,893
6,426,962
Operating loss
(2,994,565
)
(3,571,693
)
(5,933,893
)
(6,426,962
)
Other Expenses
Other income (expense)
437,433
(19,374
)
434,015
(22,307
)
Total other expenses
437,433
(19,374
)
434,015
(22,307
)
Loss from operations before income
taxes
(2,557,132
)
(3,591,067
)
(5,499,878
)
(6,449,269
)
Provision for income taxes
-
-
-
-
Net Loss
$
(2,557,132
)
$
(3,591,067
)
$
(5,499,878
)
$
(6,449,269
)
Net loss per share – basic and
diluted
$
(0.43
)
$
(1.17
)
$
(1.20
)
$
(2.46
)
Weighted average common shares – basic
and diluted
5,996,186
3,082,209
4,582,645
2,617,878
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Six Months Ended
Six Months Ended
June 30,
June 30,
2023
2022
Cash Flows from Operating
Activities
Net loss
$
(5,499,878
)
$
(6,449,269
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization
69,781
40,739
Fixed assets write off
-
599,886
Stock compensation expense including
common stock issued for RSUs
493,134
-
Amortization of right of use assets
73,974
67,158
Changes in operating assets and
liabilities:
Increase in prepaid expenses
(44,107
)
513,140
Increase in inventory
(112,916
)
(1,090,150
)
Increase in accounts payable and accrued
liabilities
318,550
(51,072
)
Decrease in lease liability
(73,980
)
(64,284
)
Net cash used in operating activities
(4,775,442
)
(6,433,852
)
Cash Flows from Investing
Activities
Purchases of fixed assets
(27,000
)
(149,153
)
Net cash used in investing activities
(27,000
)
(149,153
)
Cash Flows from Financing
Activities
Proceeds from issuance of common stock
4,712,750
8,399,512
Proceeds from issuance of warrants
20,053
-
Net cash provided by financing
activities
4,732,803
8,399,512
Net increase (decrease) in cash
(69,639
)
1,816,507
Cash, beginning of period
4,889,098
9,461,534
Cash, end of period
$
4,819,459
$
11,278,041
Supplemental disclosures of cash items
Interest paid
$
-
$
-
Income tax paid
$
-
$
-
Supplemental disclosures of non-cash
items
Stock dividend payable
$
(3,646
)
$
(8,049
)
Right of use asset
$
431,842
$
576,255
Lease liability
$
444,167
$
586,193
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230814929073/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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