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 reports financial
results for the three and nine months ended September 30, 2023 and
provides a business update. Highlights from the third quarter of
2023 and recent weeks include:
- Shared positive TAEUS clinical data at the Steatotic Liver
Disease Summit™ 2023 hosted by the European Association for the
Study of the Liver. The company shared positive study findings
in its second peer-reviewed clinical abstract, titled
"Thermoacoustic assessment of fatty liver disease - a clinical
feasibility study.” The results included 45 patient scans comparing
TAEUS liver fat fraction estimates to MRI-PDFF (Magnetic Resonance
Imaging Proton Density Fat Fraction), which is the current gold
standard for clinical measurement of liver fat fraction. The study
data yielded sensitivity of 95%, specificity of 77% and negative
predictive value (NPV) of 0.95. TAEUS estimates of liver fat
fraction were strongly correlated to MRI-PDFF scores with a Pearson
correlation coefficient of r=0.87.
- Showcased the TAEUS system at major hepatology,
endocrinology and radiology clinical conferences in the U.S. and
Europe. The ENDRA team met with prospective customers, industry
leaders and key partners at five major clinical conferences,
including most recently The Liver Meeting by the American
Association for the Study of Liver Diseases. During The Liver
Meeting, ENDRA also hosted an offsite panel discussion with
multidisciplinary key opinion leaders in the fields of hepatology,
endocrinology and radiology to share their unique perspectives on
managing Metabolic-Associated Steatotic Liver Disease (MASLD). The
commercial team continued to generate awareness for the TAEUS
system by participating in eight industry conferences
year-to-date.
- Achieved an intellectual property milestone with 70 issued
patents globally. During the third quarter of 2023 and recent
weeks, ENDRA was issued six additional patents, including two in
the U.S., two in Europe and two in China. The company is actively
exploring licensing opportunities in non-core indications to
augment the value of its growing intellectual property
portfolio.
- ENDRA's De Novo request advanced to the next stage of review
at the U.S. Food and Drug Administration (FDA). On August 14,
2023, ENDRA submitted a De Novo request for its TAEUS liver system
to the FDA and two weeks later the FDA informed ENDRA that its
submission was entering the substantive review period. The De Novo
pathway provides a means to classify novel medical devices for
which there is no legally marketed predicate device and if granted,
will strengthen TAEUS’ competitive position with its distinctive,
patent-protected capabilities as a non-invasive point-of-care tool
to aid in the characterization of Non-Alcoholic Fatty Liver Disease
(NAFLD).
“We are confident in the progress of our TAEUS system's De Novo
submission, now in substantive review with the FDA. We look forward
to ongoing collaboration with the Agency with the goal of achieving
a favorable regulatory decision. In Europe, our growing body of
clinical data is boosting commercial efforts, and we are on track
to secure the first commercial orders for our technology in the
near-term,” said Francois Michelon, Chairman and Chief Executive
Officer of ENDRA. “As treatments for steatotic liver disease
advance toward potential FDA approval in early 2024, the need for
and importance of ENDRA’s non-invasive TAEUS system to assess liver
fat becomes increasingly clear.”
Third Quarter 2023 Financial Results
Operating expenses in the third quarter of 2023 were $3.1
million, compared with $3.4 million in the third quarter in 2022.
The decrease was mainly due to lower research and development and
sales and marketing expenses.
Net loss in the third quarter of 2023 was $3.1 million, or $0.40
per share, compared with a net loss of $3.4 million, or $1.09 per
share, in the third quarter of 2022.
Cash and cash equivalents were $3.3 million as of September 30,
2023. In the third quarter, the company raised $1.2 million in
gross proceeds from the sale of common stock through its
at-the-market (ATM) equity 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 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 November 21, 2023 by
dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and
providing the passcode 4969138. 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 which
characterizes tissue similar to an 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 steatotic liver disease
(SLD) (formerly known as NAFLD-NASH), a chronic liver disease
spectrum that affects over two 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.
Condensed Consolidated Balance
Sheets
September 30,
December 31,
Assets
2023
2022
Current Assets
(Unaudited)
Cash
$
3,334,536
$
4,889,098
Prepaid expenses
305,885
490,299
Inventory
2,757,633
2,644,717
Total Current Assets
6,398,054
8,024,114
Non-Current Assets
Fixed assets, net
160,816
235,655
Right of use assets
393,451
505,816
Prepaid expenses, long term
644,610
502,576
Other assets
5,986
5,986
Total Assets
$
7,602,917
$
9,274,147
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable and accrued
liabilities
$
1,972,362
$
1,523,012
Lease liabilities, current portion
168,610
152,228
Loans
28,484
28,484
Total Current Liabilities
2,169,456
1,703,724
Lease liabilities, non-current
237,163
365,919
Total Long Term Liabilities
237,163
365,919
Total Liabilities
2,406,619
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; 8,411,777 and 3,169,103 shares issued
and outstanding, respectively
841
317
Additional paid in capital
95,664,011
89,068,015
Stock payable
2,061
6,073
Accumulated deficit
(90,470,616
)
(81,869,902
)
Total Stockholders’ Equity
5,196,298
7,204,504
Total Liabilities and Stockholders’
Equity
$
7,602,917
$
9,274,147
ENDRA Life Sciences
Inc.
Condensed Consolidated
Statements of Operations
(Unaudited)
Three Months Ended
Three Months Ended
Nine Months Ended
Nine Months Ended
September 30,
September 30,
September 30,
September 30,
2023
2022
2023
2022
Operating Expenses
Research and development
$
1,632,849
$
1,830,297
$
4,424,345
$
4,890,879
Sales and marketing
243,332
420,439
672,721
1,102,381
General and administrative
1,252,881
1,166,480
3,965,889
3,850,918
Total operating expenses
3,129,062
3,417,216
9,062,955
9,844,178
Operating loss
(3,129,062
)
(3,417,216
)
(9,062,955
)
(9,844,178
)
Other Expenses
Other income (expense)
28,226
(23,011
)
462,241
(45,318
)
Total other expenses
28,226
(23,011
)
462,241
(45,318
)
Loss from operations before income
taxes
(3,100,836
)
(3,440,227
)
(8,600,714
)
(9,889,496
)
Provision for income taxes
-
-
-
-
Net Loss
$
(3,100,836
)
$
(3,440,227
)
$
(8,600,714
)
$
(9,889,496
)
Net loss per share – basic and
diluted
$
(0.40
)
$
(1.09
)
$
(1.53
)
$
(3.53
)
Weighted average common shares – basic
and diluted
7,683,997
3,158,723
5,630,888
2,800,811
ENDRA Life Sciences
Inc.
Condensed Consolidated
Statements of Cash Flows
(Unaudited)
Nine Months
Ended
Nine Months
Ended
September 30,
September 30,
2023
2022
Cash Flows from Operating
Activities
Net loss
$
(8,600,714
)
$
(9,889,496
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization
101,839
64,532
Stock compensation expense including
common stock issued for RSUs
745,873
909,069
Amortization of right of use assets
112,365
101,957
Changes in operating assets and
liabilities:
Decrease in prepaid expenses
42,380
433,742
Increase in inventory
(112,916
)
(1,349,499
)
Increase in accounts payable and accrued
liabilities
449,350
146,660
Decrease in lease liability
(112,374
)
(97,647
)
Net cash used in operating activities
(7,374,197
)
(9,680,682
)
Cash Flows from Investing
Activities
Purchases of fixed assets
(27,000
)
(164,014
)
Net cash used in investing activities
(27,000
)
(164,014
)
Cash Flows from Financing
Activities
Proceeds from issuance of common stock,
net
5,826,582
8,399,512
Proceeds from issuance of warrants,
net
20,053
-
Net cash provided by financing
activities
5,846,635
8,399,512
Net decrease in cash
(1,554,562
)
(1,445,184
)
Cash, beginning of period
4,889,098
9,461,534
Cash, end of period
$
3,334,536
$
8,016,350
Supplemental disclosures of cash items
Interest paid
$
-
$
-
Income tax paid
$
-
$
-
Supplemental disclosures of non-cash
items
Stock dividend payable
$
(4,012
)
$
(5,373
)
Right of use asset
$
393,451
$
541,456
Lease liability
$
405,773
$
552,830
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231114274710/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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