NDRA 8-K
ENDRA Life Sciences Inc. (NDRA)
8-K
2021-08-12
For: 2021-08-12
View Original
Added on
April 06, 2026
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of the Securities Exchange Act of
1934
Date of
Report (Date of earliest event reported) August 12, 2021
ENDRA Life Sciences Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-37969
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26-0579295
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(State
or other jurisdiction of incorporation)
|
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(Commission
File Number)
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|
(IRS
Employer Identification No.)
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3600
Green Court, Suite 350 Ann Arbor, MI
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48105
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant's
telephone number, including area code
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(734)
335-0468
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(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (see General Instruction A.2.
below):
☐ Written communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities
registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common
stock, par value $0.0001 per share
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NDRA
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The
Nasdaq Stock Market LLC
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Warrants,
each to purchase one share of Common Stock
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NDRAW
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The
Nasdaq Stock Market LLC
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Indicate
by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of
1934 (§240.12b-2 of this chapter).
Emerging
growth company ☑
If an
emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial
Condition
On
August 12, 2021, ENDRA Life Sciences Inc. issued a press release
announcing its financial results for the quarter ended June 30,
2021. A copy of the press release is being furnished as Exhibit
99.1 to this Current Report on Form 8-K.
The
information in Item 2.02 of this Current Report on Form 8-K and
Exhibit 99.1 attached hereto is intended to be furnished and shall
not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934 (the “Exchange Act”) or
otherwise subject to the liabilities of that section, nor shall it
be deemed incorporated by reference in any filing under the
Securities Act of 1933 or the Exchange Act, except as expressly set
forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits
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Exhibit No.
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Description
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Press
Release dated August 12, 2021, furnished herewith.
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SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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ENDRA Life Sciences Inc.
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August
12, 2021
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By:
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/s/
Francois Michelon
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Name:
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Francois
Michelon
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Title:
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President
and Chief Executive Officer
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Exhibit 99.1
ENDRA Life Sciences Reports
Second Quarter 2021 Financial Results and Provides Business
Update
Conference call begins at 4:30 p.m. Eastern time today
ANN ARBOR, Mich. (August 12, 2021) – ENDRA Life Sciences
Inc. (“ENDRA”)
(NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound
(TAEUS®),
today reported financial results for the three months ended June
30, 2021 and provided a business update. Highlights of the second
quarter of 2021 and recent weeks include the
following:
●
Continued to screen patients at Rocky Vista
University College of Osteopathic Medicine
(“RVUCOM”). In addition, the University of
Pittsburgh Medical Center (“UPMC”) is scheduled to
commence scanning patients in the near term as it completes its
pandemic-related backlog of MRI procedures. All clinical evaluation sites will compare liver
fat measurements from the TAEUS system with the gold standard,
MRI-PDFF. RVUCOM’s study is targeting a total of 200 patients
and UPMC is targeting 75
patients.
●
Initiated in-person sales activities for the
TAEUS system in Europe. Four salespeople are driving
TAEUS’ marketing and sales efforts in Europe targeting ENDRA’s database
of prospective customers.
●
Strengthened TAEUS intellectual
property protection with issuance of additional U.S. patents.
In July, ENDRA announced the issuance
of three additional U.S. patents. Another U.S. patent was recently
issued that further protects the company’s TAEUS technology
and increases the year-to-date total to eight issued patents.
ENDRA’s intellectual property portfolio continues to grow and
currently stands at 87 global
assets, defined as patents in preparation, filed or
issued.
●
Appointed Irina Pestrikova as Senior Director
of Finance. Ms. Pestrikova has supported ENDRA since 2014
and has been actively involved in ENDRA's financial planning and
analysis, accounting and SEC reporting. Ms. Pestrikova is assuming
all day-to-day responsibilities previously performed by ENDRA's
former Chief Financial Officer, David Wells.
“ENDRA
is well-capitalized and we are putting in place the building blocks
for the global success of our Thermo Acoustic Enhanced UltraSound
technology. Although certain elements are out of our control,
including regulatory processes and the COVID-19 pandemic, we are
focused on advancing our commercial plans for TAEUS in Europe and
supporting our clinical evaluation sites worldwide, as well as
remaining highly responsive to the FDA regarding our 510(k)
submission. We continue to engage in regular, constructive
dialogues with the FDA and remain optimistic that we will receive
clearance in 2021,” stated Francois Michelon, Chairman and
Chief Executive Officer of ENDRA. “However, given that TAEUS
represents an advancement in medical ultrasound technology this
process may continue to take longer than expected. As part of our
activities to drive awareness of TAEUS, in June ENDRA participated
in the annual EASL International Liver Congress, which was attended
by approximately 7,500 clinicians, researchers and others in
gastro-hepatology, endocrinology and related specialties. We look
forward to resuming these trade shows in person as we plan to
exhibit the TAEUS system at several more industry conferences later
this year.”
“We
are pleased with Rocky Vista’s continued progress scanning
patients with our TAEUS system to generate real-world data and
bolster evidence of clinical utility. As our other domestic and
overseas partners return to delivering pre-pandemic levels of
healthcare service, we look forward to additional clinical
evaluation facilities initiating scans, with UPMC scheduled to come
online next,” commented Renaud Maloberti, ENDRA’s Chief
Commercial Officer. “In Europe, we made further progress with
our four direct salespeople now driving TAEUS’ marketing and
sales efforts, and we affirm expectations for our first commercial
sales during 2021. As COVID-19 restrictions ease somewhat
throughout Europe, we were pleased to have started in-person sales
meetings targeting potential customers in our database. These
commercialization efforts are augmented through support from our
partner GE Healthcare, with their substantial base of ultrasound
clients also being prospective TAEUS customers.”
Second Quarter 2021 Financial Results
●
Operating expenses increased to $3.2 million in the second quarter of 2021 from
$2.9 million in the same period
in 2020. The increase was primarily due to increased
spending for commercialization of TAEUS and ongoing product
development.
●
Net loss in the second quarter of 2021 was
$3.2 million, or $0.08
per share, compared with a net loss of
$2.9 million, or $0.20
per share, in the second quarter of
2020.
●
Cash and cash equivalents were $14.0
million as of June 30,
2021.
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.
Dial-in Numbers
U.S./Canada: 844-602-0380
International: 862-298-0970
Replay Dial-in Numbers
U.S./Canada: 877-481-4010
International: 919-882-2331
Replay Passcode: 42091
The telephone replay will be available through 4:30 p.m. Eastern
time on August 19, 2021
Webcast
A live audio webcast will be available through the
Events
& Presentations page of the
Investors section of the company's website
at www.endrainc.com.
A replay of the webcast will be available on the website for 60
days.
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 400,000 cart-based 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 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
forward-looking terms such as "believe," "expect," "may," "will,"
"should," "could," "seek," "intend," "plan," "goal," "estimate,"
"anticipate" or other comparable terms. Examples of forward-looking
statements include, among others, estimates of the timing of future
events and achievements, such as the expectations regarding
milestones and future sales, our 510(k) submission with the FDA and
commercializing the TAEUS®
device; and expectations concerning
ENDRA's business strategy. Forward-looking statements involve
inherent risks and uncertainties which could cause actual results
to differ materially from those in the forward-looking statements,
as a result of various factors including, among others, our ability
to develop a commercially feasible technology; receipt of necessary
regulatory approvals; the impact of COVID-19 on our business plans;
our ability to find and maintain development partners, market
acceptance of our technology, the amount and nature of competition
in our industry; our ability to protect our intellectual property;
and the other risks and uncertainties described in ENDRA's filings
with the Securities and Exchange Commission. The forward-looking
statements made in this release speak only as of the date of this
release, 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.
Company Contact:
Irina Pestrikova
Senior Director, Finance
www.endrainc.com
Investor Relations Contact:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets
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June
30,
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December
31,
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Assets
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2021
|
2020
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Current
Assets
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(Unaudited)
|
|
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Cash
|
$14,043,341
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$7,227,316
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|
Prepaid
expenses
|
968,923
|
390,800
|
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Inventory
|
1,324,791
|
589,620
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Other current
assets
|
5,986
|
5,986
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Total Current
Assets
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16,343,041
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8,213,722
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Non-Current
Assets
|
|
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Fixed assets,
net
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192,088
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212,242
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Right of use
assets
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707,504
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339,012
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Total
Assets
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$17,242,633
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$8,764,976
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Liabilities
and Stockholders’ Equity
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Current
Liabilities
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Accounts payable
and accrued liabilities
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$1,514,866
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$910,183
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Lease liabilities,
current portion
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123,192
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76,480
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Total Current
Liabilities
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1,638,058
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986,663
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Long
Term Debt
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Loans
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28,484
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337,084
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Lease
liabilities
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586,193
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271,908
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Total Long Term
Debt
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614,677
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608,992
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Total
Liabilities
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2,252,735
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1,595,655
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Stockholders’
Equity
|
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Series A
Convertible Preferred Stock, $0.0001 par value; 10,000 shares
authorized; 141.397 and 196.794 shares issued and outstanding,
respectively
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1
|
1
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Series B
Convertible Preferred Stock, $0.0001 par value; 1,000 shares
authorized; no shares issued and outstanding
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-
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-
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Common stock,
$0.0001 par value; 80,000,000 shares authorized; 41,857,352 and
34,049,704 shares issued and outstanding, respectively
|
4,185
|
3,404
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Additional paid in
capital
|
77,838,745
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64,493,611
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Stock
payable
|
74,907
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10,794
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Accumulated
deficit
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(62,927,940)
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(57,338,489)
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Total
Stockholders’ Equity
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14,989,898
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7,169,321
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Total
Liabilities and Stockholders’ Equity
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$17,242,633
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$8,764,976
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ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
|
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Three Months
Ended
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Three Months
Ended
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Six Months
Ended
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Six Months
Ended
|
|
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June 30,
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June 30,
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June 30,
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June 30,
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|
|
2021
|
2020
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2021
|
2020
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Operating
Expenses
|
|
|
|
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Research and
development
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$1,744,925
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$1,487,049
|
$2,886,411
|
$3,005,195
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Sales and
marketing
|
256,763
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134,763
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417,698
|
249,718
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General and
administrative
|
1,198,502
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1,269,467
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2,471,920
|
2,737,212
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Total operating
expenses
|
3,200,190
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2,891,279
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5,776,029
|
5,992,125
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|
|
|
|
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Operating
loss
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(3,200,190)
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(2,891,279)
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(5,776,029)
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(5,992,125)
|
|
|
|
|
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Other
Expenses
|
|
|
|
|
|
Amortization of
debt discount
|
-
|
(3,858)
|
-
|
(232,426)
|
|
Gain on
extinguishment of debt
|
-
|
-
|
308,600
|
-
|
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Other income
(expense)
|
1,086
|
1,265
|
(951)
|
7,882
|
|
Total other
expenses
|
1,086
|
(2,593)
|
307,649
|
(224,544)
|
|
|
|
|
|
|
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Loss from
operations before income taxes
|
(3,199,104)
|
(2,893,872)
|
(5,468,380)
|
(6,216,669)
|
|
|
|
|
|
|
|
Provision for
income taxes
|
-
|
-
|
-
|
-
|
|
|
|
|
|
|
|
Net
Loss
|
$(3,199,104)
|
$(2,893,872)
|
$(5,468,380)
|
$(6,216,669)
|
|
|
|
|
|
|
|
Deemed
dividend
|
-
|
-
|
(121,071)
|
-
|
|
|
|
|
|
|
|
Net loss
attributable to common stockholders
|
$(3,199,104)
|
$(2,893,872)
|
$(5,589,451)
|
$(6,216,669)
|
|
|
|
|
|
|
|
Net
loss per share – basic and diluted
|
$(0.08)
|
$(0.20)
|
$(0.14)
|
$(0.45)
|
|
|
|
|
|
|
|
Weighted
average common shares – basic and diluted
|
41,675,664
|
14,735,662
|
39,745,431
|
13,803,215
|
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
|
Six Months Ended
|
Six Months Ended
|
|
|
June 30,
|
June 30,
|
|
|
2021
|
2020
|
|
Cash
Flows from Operating Activities
|
|
|
|
Net
loss
|
$(5,468,380)
|
$(6,216,669)
|
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
Depreciation and
amortization
|
65,154
|
44,014
|
|
Common stock,
options and warrants issued for services
|
705,036
|
1,057,120
|
|
Amortization of
debt discount
|
-
|
232,426
|
|
Amortization of
right of use assets
|
44,086
|
32,199
|
|
Gain on
extinguishment of debt
|
(308,600)
|
-
|
|
Changes in
operating assets and liabilities:
|
|
|
|
Increase in prepaid
expenses
|
(578,123)
|
(947,397)
|
|
Increase in
inventory
|
(735,171)
|
(227,245)
|
|
Decrease in other
current asset
|
-
|
8,750
|
|
Decrease in
accounts payable and accrued liabilities
|
594,533
|
(493,676)
|
|
Decrease in lease
liability
|
(41,430)
|
(29,554)
|
|
Net cash used in
operating activities
|
(5,722,895)
|
(6,540,032)
|
|
|
|
|
|
Cash
Flows from Investing Activities
|
|
|
|
Purchases of fixed
assets
|
(45,000)
|
(22,350)
|
|
Net cash used in
investing activities
|
(45,000)
|
(22,350)
|
|
|
|
|
|
Cash
Flows from Financing Activities
|
|
|
|
Proceeds from
warrant exercise
|
2,785,627
|
50,438
|
|
Proceeds from
loans
|
-
|
337,084
|
|
Proceeds from
issuance of common stock
|
9,798,293
|
791,474
|
|
Payment for
settlement of notes
|
-
|
(42,260)
|
|
Net cash provided
by financing activities
|
12,583,920
|
1,136,736
|
|
|
|
|
|
Net increase
(decrease) in cash
|
6,816,025
|
(5,425,646)
|
|
|
|
|
|
Cash, beginning of
period
|
7,227,316
|
6,174,207
|
|
|
|
|
|
Cash,
end of period
|
$14,043,341
|
$748,561
|
|
|
|
|
|
Supplemental
disclosures of cash items
|
|
|
|
Interest
paid
|
$-
|
$1,920
|
|
Income tax
paid
|
$-
|
$-
|
|
|
|
|
|
Supplemental
disclosures of non-cash items
|
|
|
|
Conversion of
convertible notes and accrued interest
|
$-
|
$493,814
|
|
Deemed
dividend
|
$121,071
|
$-
|
|
Conversion of
Series A Convertible Preferred Stock
|
$(7)
|
$636
|
|
Conversion of
Series B Convertible Preferred Stock
|
$-
|
$36
|
|
Stock dividend
payable
|
$(27,652)
|
$(137,909)
|
|
Stock paid and
payable for services
|
$-
|
$40,000
|
|
Right of use
asset
|
$707,504
|
$-
|
|
Lease
liability
|
$709,385
|
$-
|
# # #