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 months and year ended December 31, 2023 and
provides a business update.
Highlights from the fourth quarter of 2023 and recent weeks
include:
- Installed first TAEUS system in the UK at King’s College
Hospital for clinical evaluation. King's College Hospital NHS
Foundation Trust (KCH) in London is one of the leading centers of
excellence in the United Kingdom's National Health Service (NHS).
KCH will use ENDRA's TAEUS liver system in a clinical study to
compare its liver fat assessment accuracy with MRI, the
acknowledged research standard. This study is expected to include
approximately 75 subjects and is intended to provide essential data
to evaluate the TAEUS technology's performance.
- FDA’s review of ENDRA's De Novo request is ongoing. In
the third quarter of 2023, ENDRA submitted a De Novo request for
its TAEUS liver system to the FDA. In the fourth quarter of 2023,
the FDA issued an Additional Information (AI) request to ENDRA. As
a result, ENDRA has had several interactions with and provided
additional details to the FDA. These efforts have fostered a better
understanding of the FDA’s expectations, which ENDRA is working to
achieve. ENDRA has confirmed an in-person FDA meeting in the second
quarter of 2024.
- Showcased the TAEUS system at key hepatology, endocrinology
and radiology medical conferences in the U.S. and Europe.
During the fourth quarter and recent weeks, the ENDRA team met with
prospective customers, industry leaders and key partners at four
major clinical conferences, including 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 Dysfunction-Associated Steatohepatitis
(MASH).
- Expanded intellectual property portfolio to 75 issued
patents globally. During the fourth quarter of 2023 and recent
weeks, ENDRA was issued seven additional patents, including three
in the U.S., one in Europe and three in China. The company is
actively exploring licensing opportunities in non-core indications
to augment the value of its growing intellectual property
portfolio.
- New ICD-10-CM code issued, which paves the way for improved
NAFLD diagnostics. The International Classification of
Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), a
global coding system used to indicate a diagnosis for reimbursement
purposes and issued by the World Health Organization, included
NAFLD under the ICD-10 K76.0 code. This facilitates standardized
billing for the diagnosis of NAFLD, is applicable across the U.S.,
Europe and other regions, and promotes consistency in medical
documentation and insurance processes. ENDRA believes the issuance
of the ICD-10 K76.0 code specifically for NAFLD measurement
represents a significant opportunity for innovation in liver health
diagnostics as healthcare providers now have a clearer pathway to
integrate advanced diagnostic technologies, including the
TAEUS system.
"With the first therapeutic to treat MASH recently approved by
the FDA, updated guidelines that include the screening of fatty
liver in adults with type 2 diabetes, pre-diabetes and obesity, and
new codes that aid reimbursement, there is accelerating momentum in
the marketplace for a non-invasive diagnostic tool to assess liver
fat like the TAEUS system,” said Francois Michelon, Chairman and
Chief Executive Officer of ENDRA. "We continue to collaborate with
the FDA and look forward to advancing the regulatory process. In
addition, we continue to drive commercial efforts to build
awareness of the TAEUS system in Europe. After the recent
installation in the UK, we expect the activation of other clinical
evaluation sites in Europe and North America this year to bolster
data collection and gain traction with potential customers in each
of these regions.”
Fourth Quarter 2023 Financial Results
Operating expenses in the fourth quarter of 2023 were $1.5
million, compared with $3.3 million in the fourth quarter in 2022.
The decrease was mainly due to lower research and development and
general and administrative expenses.
Net loss in the fourth quarter of 2023 was $1.5 million, or
$0.17 per share, compared with a net loss of $3.3 million, or $1.04
per share, in the fourth quarter of 2022.
Full Year 2023 Financial Results
Operating expenses in 2023 were $10.5 million, compared with
$13.2 million in 2022. The decrease was mainly due to lower
research and development and sales and marketing expenses.
Net loss in 2023 was $10.1 million, or $1.58 per share, compared
with a net loss of $13.2 million, or $4.56 per share, in 2022.
Cash and cash equivalents were $2.8 million as of December 31,
2023.
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 start of the call. 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 April 4, 2024 by
dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and
providing the passcode 8041087. 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
its development efforts, including the timing of submission for and
receipt of required regulatory approvals and product launches and
sales; 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; ENDRA’s ability to maintain compliance
with Nasdaq listing standards; ENDRA’s dependence on its senior
management team; 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
December 31,
December 31,
Assets
2023
2022
Current Assets
Cash and cash equivalents
$
2,833,907
$
4,889,098
Prepaid expenses
198,905
490,299
Total Current Assets
3,032,812
5,379,397
Non-Current Assets
Inventory
2,622,865
2,644,717
Fixed assets, net
111,782
235,655
Right of use assets
354,091
505,816
Prepaid expenses, long term
626,610
502,576
Other assets
5,986
5,986
Total Assets
$
6,754,146
$
9,274,147
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable and accrued
liabilities
$
700,754
$
1,523,012
Lease liabilities, current portion
173,857
152,228
Loans
28,484
28,484
Total Current Liabilities
903,095
1,703,724
Long Term Debt
Loans, long term
-
-
Lease liabilities
192,062
365,919
Total Long Term Debt
192,062
365,919
Total Liabilities
1,095,157
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; 10,390,150 and 3,169,103 shares
issued and outstanding, respectively
1,039
317
Additional paid in capital
97,582,868
89,068,015
Stock payable
5,233
6,073
Accumulated deficit
(91,930,152
)
(81,869,902
)
Total Stockholders’ Equity
5,658,989
7,204,504
Total Liabilities and Stockholders’
Equity
$
6,754,146
$
9,274,147
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Operations
Year Ended
Year Ended
December 31,
December 31,
2023
2022
Operating Expenses
Research and development
$
5,003,695
$
6,554,194
Sales and marketing
820,554
1,429,150
General and administrative
4,696,486
5,174,215
Total operating expenses
10,520,735
13,157,559
Operating loss
(10,520,735
)
(13,157,559
)
Other Income (Expenses)
Other income (expenses)
460,485
(21,533
)
Total other income (expenses)
460,485
(21,533
)
Loss from operations before income
taxes
(10,060,250
)
(13,179,092
)
Provision for income taxes
-
-
Net Loss
$
(10,060,250
)
$
(13,179,092
)
Net loss per share – basic and
diluted
$
(1.58
)
$
(4.56
)
Weighted average common shares – basic
and diluted
6,363,759
2,891,292
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
Year Ended
Year Ended
December 31,
December 31,
2023
2022
Cash Flows from Operating
Activities
Net loss
$
(10,060,250
)
$
(13,179,092
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization
123,726
96,661
Fixed assets write off
24,868
1,391
Inventory reserve
138,045
-
Stock compensation expense including
common stock issued for RSUs
996,430
1,199,838
Amortization of right of use assets
151,725
137,597
Changes in operating assets and
liabilities:
Decrease in prepaid expenses
167,360
355,128
Increase in inventory
(116,193
)
(1,360,139
)
Decrease in accounts payable and accrued
liabilities
(822,258
)
111,575
Decrease in lease liability
(152,228
)
(132,330
)
Net cash used in operating activities
(9,548,775
)
(12,769,371
)
Cash Flows from Investing
Activities
Purchases of fixed assets
(33,884
)
(202,577
)
Proceeds from sale of fixed assets
9,163
-
Net cash used in investing activities
(24,721
)
(202,577
)
Cash Flows from Financing
Activities
Proceeds from issuance of common stock
6,483,393
8,399,512
Proceeds from issuance of warrants
20,053
-
Proceeds from warrant exercise
1,014,859
-
Net cash provided by financing
activities
7,518,305
8,399,512
Net decrease in cash
(2,055,191
)
(4,572,436
)
Cash, beginning of year
4,889,098
9,461,534
Cash, end of year
$
2,833,907
$
4,889,098
Supplemental disclosures of cash items
Interest paid
$
44,985
$
59,113
Income tax paid
$
-
$
-
Supplemental disclosures of non-cash
items
Stock dividend payable
$
840
$
7,790
Right of use asset
$
354,091
$
505,816
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240328043502/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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