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, 2023 and provided a
business update. Highlights include:
- Completed enrollment of subjects and data collection for FDA
De Novo request, with more than 100 TAEUS system scans utilizing
new interactive guidance tool performed at global clinical
investigational sites. In early 2023, ENDRA implemented a
software guidance tool to enhance performance of its TAEUS system
at several clinical evaluation sites and recently completed data
collection on more than 100 TAEUS scans and MRI confirmatory scans.
With the requisite data collection now complete, ENDRA is
finalizing that portion of its De Novo request to the U.S. Food and
Drug Administration (FDA). The data will also be used to support
commercialization of the TAEUS liver device in Europe and, after
FDA clearance, in the U.S.
- Preparing De Novo FDA submission. In the U.S., ENDRA is
pursuing the De Novo regulatory pathway for its TAEUS liver device,
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 is reserved for novel
technologies and should assist ENDRA in achieving the strongest
market position with TAEUS-optimized claims. Given the completion
of data collection, ENDRA plans to submit the request
mid-2023.
- Highlighted TAEUS’ liver system capabilities at clinical
conferences. The ENDRA team continues to drive awareness of the
TAEUS system by meeting with prospective customers and partners at
clinical conferences in the U.S. and Europe. In the first quarter,
ENDRA participated in the Francophone Society of Diabetes annual
meeting. In addition, the Company’s peer-reviewed clinical abstract
titled “Thermoacoustic assessment of fatty liver disease - an early
clinical feasibility study” was accepted for a poster presentation
at the prestigious European Association for the Study of the Liver
(EASL) Congress, being held June 21-24 in Vienna. Acceptance of
this abstract for presentation is a significant step in raising
awareness and demonstrating the capabilities of TAEUS among
prospective clinical users and driving commercial adoption.
- Continued expansion of intellectual property portfolio to 63
issued patents globally. Year-to-date, seven patents were
issued to ENDRA, including three in the U.S., two in Europe and two
in China. These patents support ENDRA’s strategy to protect the
TAEUS system for its initial indication of measuring liver fat, as
well as other potential applications such as monitoring tissue
temperature during surgical procedures. In addition, ENDRA is
pursuing licensing opportunities in non-core indications to further
enhance the value of its intellectual property portfolio.
- Subsequent to the close of the quarter, raised $4.5 million
and extended cash runway. The Company raised $4.5 million in
net proceeds from the sale of common stock and warrants in a public
offering. With this bolstered cash position, management believes
ENDRA is capitalized to fund operations through several important
milestones, including advancing the TAEUS system through the
regulatory process in the U.S. and supporting commercial activities
in Europe.
“We are pleased to announce completion of the data collection at
our global clinical evaluation sites to support our planned TAEUS
U.S. regulatory submission. The data collected year-to-date is from
TAEUS scans guided by our interactive software tool, which
demonstrated marked improvement in intra-operator performance and
reliability. We believe these scans and MRI confirmatory data will
demonstrate the ability of TAEUS to measure liver fat in the
earlier stages of NAFLD and at the point of patient care. We are
analyzing this data, and expect to make our De Novo submission to
the FDA mid-year,” stated Francois Michelon, Chairman and Chief
Executive Officer of ENDRA. “In addition, we strengthened our
balance sheet with an upsized $4.5 million capital raise from
long-term ENDRA shareholders and insiders. This capital infusion
provides a cash runway to achieve key regulatory and commercial
milestones for our TAEUS system.”
First Quarter 2023 Financial Results
In the first quarter of 2023, our operating expenses were $2.9
million, unchanged from the first quarter in 2022. Increases in
research and development and general and administrative expenses
were offset by decreases in sales and marketing expenses.
Net loss in the first quarter of 2023 was $2.9 million, or $0.93
per share, compared with a net loss of $2.9 million, or $1.33 per
share, in the first quarter of 2022.
Cash and cash equivalents were $2.4 million as of March 31,
2023. Subsequent to the close of the quarter, the Company raised
$4.5 million in net proceeds through a registered 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 May 22, 2023 by
dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and
providing the passcode 8983905. 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 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.
Consolidated Balance
Sheets
March 31,
December 31,
Assets
2023
2022
Current Assets
(Unaudited)
Cash
$
2,355,251
$
4,889,098
Prepaid expenses
428,529
490,299
Inventory
2,735,349
2,644,717
Total Current Assets
5,519,129
8,024,717
Non-Current Assets
Fixed assets, net
228,139
235,655
Right of use assets
469,290
505,816
Vendor advance
432,344
502,576
Other assets
5,986
5,986
Total Assets
$
6,654,888
$
9,274,147
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable and accrued
liabilities
$
1,645,749
$
1,523,012
Lease liabilities, current portion
157,554
152,228
Loans
28,484
28,484
Total Current Liabilities
1,831,787
1,703,724
Long Term Debt
Lease liabilities
324,064
365,919
Total Long Term Debt
324,064
365,919
Total Liabilities
2,155,851
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
Common stock, $0.0001 par value;
80,000,000 shares authorized; 3,169,103 shares issued and
outstanding
317
317
Additional paid in capital
89,307,675
89,068,015
Stock payable
3,692
6,073
Accumulated deficit
(84,812,648
)
(81,869,902
)
Total Stockholders’ Equity
4,499,037
7,204,504
Total Liabilities and Stockholders’
Equity
$
6,654,888
$
9,274,147
ENDRA Life Sciences
Inc.
Consolidated Statements of
Operations
(Unaudited)
Three Months Ended
Three Months Ended
March 31,
March 31,
2023
2022
Operating Expenses
Research and development
$
1,391,314
$
1,213,022
Sales and marketing
181,616
339,903
General and administrative
1,366,398
1,302,344
Total operating expenses
2,939,328
2,855,269
Operating loss
(2,939,328
)
(2,855,269
)
Other Expenses
Other income (expense)
(3,418
)
(2,933
)
Total other expenses
(3,418
)
(2,933
)
Loss from operations before income
taxes
(2,942,746
)
(2,858,202
)
Provision for income taxes
-
-
Net Loss
$
(2,942,746
)
$
(2,858,202
)
Net loss per share – basic and
diluted
$
(0.93
)
$
(1.33
)
Weighted average common shares – basic
and diluted
3,169,103
2,152,711
ENDRA Life Sciences
Inc.
Condensed Consolidated
Statements of Cash Flows
(Unaudited)
Three Months Ended
Three Months Ended
March 31,
March 31,
2023
2022
Cash Flows from Operating
Activities
Net loss
$
(2,942,746
)
$
(2,858,202
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization
34,516
19,038
Stock compensation expense including
common stock issued for RSUs
237,279
288,537
Amortization of right of use assets
36,526
33,179
Changes in operating assets and
liabilities:
Decrease in prepaid expenses
132,002
286,597
Increase in inventory
(90,632
)
(645,680
)
Increase in accounts payable and accrued
liabilities
122,737
(190,597
)
Decrease in lease liability
(36,529
)
(31,742
)
Net cash used in operating activities
(2,506,847
)
(3,098,870
)
Cash Flows from Investing
Activities
Purchases of fixed assets
(27,000
)
(89,353
)
Net cash used in investing activities
(27,000
)
(89,353
)
Cash Flows from Financing
Activities
Proceeds from issuance of common stock
-
854,052
Net cash provided by financing
activities
-
854,052
Net increase (decrease) in cash
(2,533,847
)
(2,334,171
)
Cash, beginning of period
4,889,098
9,461,534
Cash, end of period
$
2,355,251
$
7,127,363
Supplemental disclosures of cash items
Interest paid
$
-
$
-
Income tax paid
$
-
$
-
Supplemental disclosures of non-cash
items
Stock dividend payable
$
2,381
$
5,089
Right of use asset
$
469,290
$
610,234
Lease liability
$
481,618
$
618,735
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230515005784/en/
Company: Irina Pestrikova Senior Director, Finance
investors@endrainc.com www.endrainc.com
Investor Relations: Yvonne Briggs LHA Investor Relations
(310) 691-7100 ybriggs@lhai.com
ENDRA Life Sciences (NASDAQ:NDRA)
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ENDRA Life Sciences (NASDAQ:NDRA)
過去 株価チャート
から 5 2023 まで 5 2024