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®), reports financial results
for the three and six months ended June 30, 2024, as filed in a
Form 10-Q on August 14, 2024, and provides the following business
update:
New executive team
- Subsequent to quarter-end, ENDRA announced leadership
changes. Board member Alexander Tokman was appointed as acting
CEO, bringing 24+ years of global commercial leadership experience.
Additionally, two industry veterans joined in key roles including
regulatory and clinical affairs, and finance. Richard Jacroux, new
Chief Financial Officer, has over 20 years of experience in
financial management and accounting and has held the role of CFO at
several technology companies. Ziad Rouag, Head of Regulatory and
Clinical Affairs, brings to ENDRA more than two decades of
experience in the medical device industry as a leader of clinical
operations and regulatory affairs for emerging startups and
high-growth businesses.
Focus on clinical and regulatory activities
- Advanced the U.S. regulatory process. ENDRA met with the
U.S. Food and Drug Administration (FDA) at their headquarters in
Maryland to demonstrate the TAEUS technology and review the
clinical and statistical plans. The meeting minutes confirmed
alignment on the topics discussed and the steps required for a
successful regulatory outcome. To drive the process forward, ENDRA
has hired Mr. Rouag, an experienced regulatory and clinical
leader.
- Started new pilot clinical trials. New pilot trials were
initiated at two clinical sites in North America and one is
expected to commence in Europe to generate data that support TAEUS'
value to clinical users. ENDRA will use the data from these sites
to demonstrate the TAEUS system’s performance to the FDA before
initiating the De Novo pivotal study.
- Expanded the intellectual property portfolio, now with 81
issued patents globally. During the second quarter of 2024,
ENDRA was issued five additional patents, including three in Europe
and two in China. ENDRA’s broad intellectual property portfolio
provides protection for the TAEUS system with its novel
thermoacoustic technology and the opportunity to explore licensing
opportunities for indications beyond its core focus.
Raised capital and significantly reduced operating
expenses
- Raised $8.0 million in a public offering. The company
raised approximately $8.0 million in gross proceeds from the sale
of common stock and warrants in a public offering.
- Significantly reduced operating expenses. As part of
focusing resources on clinical and regulatory activities, ENDRA
restructured operations, reducing annualized expenses by $3.1
million compared with the prior-year second quarter.
“In the near-term, the company is prioritizing securing the
clinical data to support a new De Novo regulatory filing with the
FDA above all other goals,” said Alexander Tokman, acting Chief
Executive Officer. “In parallel, we are revisiting our go-to-market
strategy for TAEUS to ensure we are prioritizing the most promising
vertical markets while formalizing our longer-term business
strategy and crystalizing our vision for ENDRA. All of this is
being done with careful attention to operating expenses, which we
recently reduced by 26% on an annualized basis without impacting
any of our primary deliverables.”
Second Quarter 2024 Financial Results
Operating expenses in the second quarter of 2024 were $2.2
million, compared with $3.0 million in the second quarter in 2023.
The decrease was mainly due to lower research and development
expenses as we shift resources and spending from development to
clinical activities and product optimization.
Cash and cash equivalents were $6.4 million as of June 30, 2024.
In June 2024, the Company raised approximately $7.3 million in net
proceeds through a public offering.
Conference Call and Webcast
Management will host a conference call and webcast beginning at
4:30 p.m. Eastern time today, 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 August 29, 2024 by
dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and
providing the passcode 5567407. 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 that
characterizes tissue similar to an MRI, but at 1/40th the cost and
at the point of patient care. TAEUS® is initially focused on the
non-invasive assessment of fatty tissue in the liver. Steatotic
liver disease (SLD, formerly known as NAFLD-NASH) is 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 non-invasive 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:
expectations with respect to FDA requirements regarding its
clinical trials and de novo submission for its TAEUS liver device;
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 FDA and other 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
regain compliance with Nasdaq listing standards and remain listed
on a securities exchange; 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
June 30,
December 31,
Assets
2024
2023
Current Assets
(Unaudited)
Cash
$
6,400,732
$
2,833,907
Prepaid expenses
312,742
198,905
Total Current Assets
6,713,474
3,032,812
Non-Current Assets
Inventory
2,711,923
2,622,865
Fixed assets, net
91,777
111,782
Right of use assets
272,284
354,091
Prepaid expenses, long term
647,085
626,610
Other assets
5,986
5,986
Total Assets
$
10,442,529
$
6,754,146
Liabilities
and Stockholders’ Equity
Current Liabilities
Accounts payable and accrued
liabilities
$
1,167,434
$
700,754
Lease liabilities, current portion
182,733
173,857
Loans
-
28,484
Total Current Liabilities
1,350,167
903,095
Long Term Debt
Lease liabilities
98,421
192,062
Total Long Term Debt
98,421
192,062
Total Liabilities
1,448,588
1,095,157
Stockholders’ Equity
Series A Convertible Preferred Stock,
$0.0001 par value; 10,000 shares authorized; 17.488 and 141.397
shares issued and outstanding, respectively
-
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;
1,000,000,000 shares authorized; 72,439,526 and 10,390,150 shares
issued and outstanding, respectively
7,244
1,039
Additional paid in capital
105,921,675
97,582,868
Stock payable
27
5,233
Accumulated deficit
(96,935,005
)
(91,930,152
)
Total Stockholders’ Equity
8,993,941
5,658,989
Total Liabilities and Stockholders’
Equity
$
10,442,529
$
6,754,146
ENDRA Life Sciences Inc.
Condensed 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,
2024
2023
2024
2023
Operating Expenses
Research and development
$
716,366
$
1,400,182
$
1,757,892
$
2,791,496
Sales and marketing
162,952
247,773
401,612
429,389
General and administrative
1,351,535
1,346,610
2,851,890
2,713,008
Total operating expenses
2,230,853
2,994,565
5,011,394
5,933,893
Operating loss
(2,230,853
)
(2,994,565
)
(5,011,394
)
(5,933,893
)
Other Income
Other income
1,700
437,433
6,541
434,015
Total other income
1,700
437,433
6,541
434,015
Loss from operations before income
taxes
(2,229,153
)
(2,557,132
)
(5,004,853
)
(5,499,878
)
Provision for income taxes
-
-
-
-
Net Loss
$
(2,229,153
)
$
(2,557,132
)
$
(5,004,853
)
$
(5,499,878
)
Net loss per share – basic and diluted
$
(0.08
)
$
(0.43
)
$
(0.26
)
$
(1.20
)
Weighted average common shares – basic and
diluted
27,283,009
5,996,186
18,998,902
4,582,645
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240822003939/en/
Company: Richard Jacroux Chief Financial Officer
investors@endrainc.com www.endrainc.com
Investor Relations: Yvonne Briggs LHA Investor Relations
(310) 691-7100 ybriggs@lhai.com
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