NDRA 8-K
ENDRA Life Sciences Inc. (NDRA)
8-K
2020-05-14
For: 2020-05-14
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)
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May 14,
2020
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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 May 14, 2020, ENDRA Life Sciences Inc. issued a press release
announcing its financial results for the quarter ended March 31,
2020. 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 May 14, 2020, 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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May 14,
2020
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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 Provides Business Update and Reports First
Quarter 2020 Financial Results
ANN ARBOR, MI / ACCESSWIRE / May 14, 2020 / ENDRA Life
Sciences Inc. ("ENDRA") (NASDAQ:NDRA), the pioneer of Thermo
Acoustic Enhanced UltraSound (TAEUS™), today provided a
business update and reported first quarter 2020 financial
results.
"I
could not be more pleased with the progress we've made during these
challenging times to keep the company on track to receive critical
regulatory approvals and advance commercialization activities on
schedule in Europe and the United States," said Francois Michelon,
Chairman and Chief Executive Officer. "The receipt of the CE Mark
for our TAEUS liver system ahead of schedule in the first quarter
positions the company to be one of the first to start positively
impacting the lives of more than one billion people globally
affected by Non-Alcoholic Fatty Liver Disease (NAFLD) and
Non-Alcoholic Steatohepatitis (NASH), where there is an acute need
for a practical tool to assess and monitor liver fat before it
progresses to fibrosis, cirrhosis and cancer."
Q1 2020 and Recent Business Highlights
●
Received CE Mark
Approval for TAEUS FLIP (Fatty Liver Imaging Probe) System
targeting NAFLD and NASH.
●
Renewed
collaboration agreement with the GE Healthcare unit of General
Electric Company, extending the agreement's term to January
2021.
●
Increased
intellectual property portfolio to 68 assets defined, filed, issued
and licensed patents and pending patent applications, including a
key patent to expand into a future clinical market - monitoring
tissue temperature during thermal ablation and cryotherapy
procedures, for which there are also currently no practical
clinical tools.
●
Expanded Scientific
Advisory Board with the addition of Raza Malik, M.D., Director of
Hepatology and Associate Chief of the Division of Gastroenterology
at Tufts Medical Center in Boston.
●
Remain on track for
key milestones to establish clinical evaluation reference sites and
initiate sales in Europe in the second half of 2020, as well as to
submit a 510(k) regulatory package to the Food and Drug
Administration (FDA) in the second quarter of 2020.
Financial Results for Q1, 2020
●
Operating expenses
increased to $3.1 million in the first quarter of 2020, up from
$2.7 million in the first quarter of 2019. The increase in
operating expenses was primarily due to employment related costs
including non-cash expenses for stock compensation, costs
associated with being a publicly traded company including investor
relations, and increased costs for insurance.
●
Net loss in Q1 2020
totaled $3.3 million, or ($0.29) per basic and diluted share, as
compared to a net loss of $2.7 million, or ($0.37) per basic and
diluted share in Q1 2019.
●
Cash at March 31,
2020 totaled $3.1 million, as compared to $6.2 million at December
31, 2019, with no long-term debt outstanding.
Conference Call and Webcast Access
Management
will host a conference call and webcast today at 4:30 p.m. ET to
discuss the results and provide an update on recent corporate
developments.
Dial-in Number
U.S./Canada
Dial-in Number: 844-369-8774
International
Dial-in Number: 862-298-0844
Replay
Dial-in Number: 877-481-4010
Replay
International Dial-in Number: 919-882-2331
Replay
Passcode: 34662
A
telephone replay will be available May 14, 2020 through 4:30 p.m.
ET on May 21, 2020.
A live
audio webcast will be available through the Events and
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 90
days.
About ENDRA Life Sciences Inc.
ENDRA
Life Sciences Inc. is the pioneer of Thermo Acoustic Enhanced
UltraSound (TAEUS™), a ground-breaking technology that
mirrors some applications similar to CT or MRI, but at
50X lower cost, at
the point of patient care. TAEUS is designed to work in concert
with one million ultrasound systems in global use today. TAEUS is
initially focused on the measurement of fat in the liver, as a
means to assess and monitor NAFLD and NASH, chronic liver
conditions that affect over 1 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.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; the timing of; making 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:
David
Wells
Chief
Financial Officer
(734)
997-0464
www.endrainc.com
Media Relations Contact:
Denise
DiMeglio
(610)
228-2102
Investor Relations Contact:
Joe
Hassett
(484)
686-6600
ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets
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March
31,
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December
31,
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Assets
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2020
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2019
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Assets
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(unaudited)
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Cash
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$3,102,728
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$6,174,207
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Prepaid
expenses
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373,254
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116,749
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Inventory
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174,935
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113,442
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Other current
assets
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121,951
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130,701
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Total Current
Assets
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3,772,868
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6,535,099
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Other
Assets
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Fixed assets,
net
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237,015
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236,251
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Right of use
assets
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389,004
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404,919
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Total
Assets
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$4,398,887
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$7,176,269
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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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$1,444,035
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$1,708,525
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Convertible notes
payable, net of discount
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38,402
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298,069
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Lease liabilities,
current portion
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68,608
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66,193
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Total Current
Liabilities
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1,551,045
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2,072,787
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Long
Term Debt
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Lease
liabilities
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325,804
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342,812
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Total Long Term
Debt
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325,804
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342,812
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Total
Liabilities
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1,876,849
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2,415,599
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Stockholders’
Equity
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Preferred stock
series A, $0.0001 par value; 10,000 shares authorized; 2,441.92
shares issued and outstanding
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1
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1
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Preferred stock
series B, $0.0001 par value; 1,000 shares authorized; 121.58 shares
issued and outstanding
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-
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-
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Common stock,
$0.0001 par value; 50,000,000 shares authorized; 13,553,005 and
8,421,401shares issued and outstanding
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1,355
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842
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Additional paid in
capital
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50,982,080
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49,933,736
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Stock
payable
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78,836
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43,528
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Accumulated
deficit
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(48,540,234)
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(45,217,437)
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Total
Stockholders’ Equity
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2,522,038
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4,760,670
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Total
Liabilities and Stockholders’ Equity
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$4,398,887
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$7,176,269
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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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March
31,
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March
31,
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2020
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2019
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Operating
Expenses
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Research and
development
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$1,518,146
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$1,773,498
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Sales and
marketing
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114,955
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56,818
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General and
administrative
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1,467,745
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916,903
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Total operating
expenses
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3,100,846
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2,747,219
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Operating
loss
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(3,100,846)
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(2,747,219)
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Other
Expenses
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Amortization of
debt discount
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(228,568)
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-
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Other income
(expense)
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6,617
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(1,517)
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Total other
expenses
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(221,951)
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(1,517)
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Loss from
operations before income taxes
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(3,322,797)
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(2,748,736)
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Provision for
income taxes
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-
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-
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Net
Loss
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$(3,322,797)
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$(2,748,736)
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Net
loss per share – basic and diluted
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$(0.29)
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$(0.37)
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Weighted
average common shares – basic and diluted
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11,508,843
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7,422,642
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ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Three Months Ended
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Three Months Ended
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March 31,
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March 31,
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2020
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2019
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Cash
Flows from Operating Activities
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Net
loss
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$(3,322,797)
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$(2,748,736)
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Adjustments to
reconcile net loss to net cash used in operating
activities:
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Depreciation and
amortization
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21,586
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19,632
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Common stock,
options and warrants issued for services
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511,080
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302,268
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Amortization of
debt discount
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228,568
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-
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Amortization of
right of use assets
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15,915
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-
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Stock payable for
investor relations
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40,000
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-
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Changes in
operating assets and liabilities:
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Decrease (increase)
in prepaid expenses
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(256,505)
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40,354
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Decrease in lease
liability
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(14,593)
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-
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Increase in
inventory
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(61,493)
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(14,831)
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Increase in other
asset
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8,750
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-
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Increase in
accounts payable and accrued liabilities
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(256,878)
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(139,349)
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Net cash used in
operating activities
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(3,088,367)
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(2,540,662)
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Cash
Flows from Investing Activities
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Purchases of fixed
assets
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(22,350)
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(5,239)
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Net cash used in
investing activities
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(22,350)
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(5,239)
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Cash
Flows from Financing Activities
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Proceeds from
warrant exercise
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39,238
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-
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Net cash provided
by financing activities
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39,238
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-
|
|
|
|
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Net decrease in
cash
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(3,071,479)
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(2,545,901)
|
|
|
|
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Cash, beginning of
period
|
6,174,207
|
6,471,375
|
|
|
|
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Cash,
end of period
|
$3,102,728
|
$3,925,474
|
|
|
|
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Supplemental
disclosures of cash items
|
|
|
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Interest
paid
|
$1,920
|
$-
|
|
Income tax
paid
|
$-
|
$-
|
|
|
|
|
|
Supplemental
disclosures of non-cash items
|
|
|
|
Conversion of
convertible notes and accrued interest
|
$493,814
|
$-
|
|
Conversion of
Series A Convertible Preferred Stock
|
$(452)
|
$-
|
|
Conversion of
Series B Convertible Preferred Stock
|
$(23)
|
$-
|
|
Stock dividend
payable
|
$34,066
|
$-
|
|
Right of use
asset
|
$389,004
|
$-
|
|
Lease
liability
|
$394,412
|
$-
|