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
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Date of
Report (Date of earliest event reported)
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December
16, 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
1.01
Entry
into a Material Definitive Agreement.
On
December 16, 2020, ENDRA Life Sciences Inc. (the
“Company”) entered into Amendment 4 (the
“Amendment”) to that certain Collaborative Research
Agreement between the Company and General Electric Company
(“GE”), dated as of April 22, 2016, as amended by that
certain Amendment 1 to Collaborative Research Agreement, dated
April 21, 2017, that certain Amendment 2 to Collaborative Research
Agreement, dated January 30, 2018, and that certain Amendment 3 to
Collaborative Research Agreement, dated January 13, 2020 (the
“Agreement”). The Amendment extends the term of the
Agreement to December 16, 2022.
A copy
of the Amendment is filed as Exhibit 10.1 to this Current Report on
Form 8-K. The foregoing description is not complete and is
qualified in its entirety by reference to the full text of the
Amendment, which is incorporated herein by reference. In the event
of any conflict between this summary and the full text of the
Amendment, the text of the Amendment shall control.
Item
7.01
Regulation
FD Disclosure
On
December 21, 2020, the Company issued a press release announcing
its entry into the Amendment. The press release incorrectly
described the two-year extension as ending on December 16, 2023,
rather than December 16, 2022. A copy of the press release is being
furnished as Exhibit 99.1 to this Current Report on Form
8-K.
The
information furnished in Item 7.01 of this Current Report on
Form 8-K, including Exhibit 99.1 attached hereto, 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 into 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.
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Exhibit No.
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Description
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Amendment
4 to Collaborative Research Agreement, dated December 16, 2020, by
and between the Company and General Electric Company.
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Press
Release dated December 21, 2020 issued by the Company, 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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December
21, 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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AMENDMENT
4
TO
THE
COLLABORATIVE
RESEARCH AGREEMENT
BETWEEN
GENERAL
ELECTRIC COMPANY
AND
ENDRA
LIFE SCIENCES INC.
This
Amendment 4 to the Collaborative Research Agreement ("Amendment"),
effective as of the last date of signing below ("Effective Date"),
amends the Collaborative Research Agreement between General
Electric ("GE") & ENDRA Life Sciences Inc. ("ENDRA"), which
became effective as of April 22, 2016, as amended by that certain
Amendment 1 to the Collaborative Research Agreement, dated April
21, 2017, that certain Amendment 2 to the Collaborative Research
Agreement, dated January 30, 2018, and that certain Amendment 3 to
the Collaborative Research Agreement, dated January 13, 2020 (the
"Agreement").
RECITALS
WHEREAS, the
parties wish to amend the Agreement to provide for a revised TERM,
which includes changes to the Agreement as set forth
below.
THEREFORE, the
parties hereby agree to the following amendment:
1.
Section 9.1 of the
Agreement shall be deleted and restated as follows:
This Agreement will remain in effect until
December 16, 20221 unless
terminated sooner or extended in writing signed by the parties in
accordance with this Agreement.
2.
Capitalized terms
not defined in this Amendment will have the meanings assigned in
the Agreement.
3.
Except as
explicitly modified, all terms, conditions and provisions of the
Agreement shall continue in full force and effect.
4.
In the event of any
inconsistency or conflict between the Agreement and this Amendment,
the terms, conditions and provisions of this Amendment shall govern
and control.
5.
This Amendment and
the Agreement constitute the entire and exclusive agreement between
the parties with respect to this subject matter. All previous
discussions and agreements with respect to this subject matter are
superseded by the Agreement and this Amendment.
Signature Page Follows
_____________________________
Acceptance
of these terms is documented by the signature and date of the
responsible parties in the space designated below.
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GE Healthcare
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ENDRA Life Sciences Inc.
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Signature:
/s/ Brian
McEathron
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Signature:
/s/ Francois
Michelon
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Name:
Brian McEathron
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Name:
Francois Michelon
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Title:
GM General Imaging Ultrasound
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Title:
CEO
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Date:
16-Dec-2020
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Date:
Dec 16, 2020
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ENDRA Life
Sciences Extends GE Healthcare Collaboration Agreement for Two
Years
Supports Commercialization of
TAEUSⓇ
Product for Imaging NAFLD/NASH to
December 2023
ANN ARBOR, MI / ACCESSWIRE / December 21, 2020 /
ENDRA Life Sciences Inc.
("ENDRA") (NASDAQ: NDRA), a pioneer of
Thermo Acoustic Enhanced UltraSound (TAEUSⓇ),
today announced it has renewed its collaboration agreement with the
GE Healthcare unit of General Electric Company, extending the
agreement's term by two years to December 16,
2023.
"We are very pleased to renew our collaboration agreement with GE
Healthcare, the global leader in clinical ultrasound and ENDRA's
partner since 2016, to cap the year with another significant
achievement,” said Francois Michelon, CEO of ENDRA. "Over the
past 60 days ENDRA has deployed its first clinical systems to Rocky
Vista University and the University of Pittsburgh Medical Center,
signed a clinical evaluation agreement with a second European site
at CHU-Angers France, signed an exclusive three-year agreement with
a Vietnamese distributor for more than 40 TAEUS systems, and
received its seventh Chinese patent for TAEUS. We have remarkable
momentum as we cross the 2020 finish line and enter 2021,"
concluded Mr. Michelon.
Under the terms of the agreement, which extended the previous
12-month agreement by 24 months, GE Healthcare will continue to
support ENDRA's commercialization activities for its TAEUS
technology for use in a fatty liver application by, among other
things, facilitating introductions to GE Healthcare clinical
ultrasound customers worldwide. In return for this assistance,
ENDRA will afford GE Healthcare certain rights of first offer with
respect to manufacturing and licensing rights for the target
application.
"ENDRA's technology has the potential to bring significant new
capabilities to ultrasound and address unmet clinical needs in
point-of-care NAFLD/NASH assessment and monitoring, which aligns
with GE Healthcare's mission to increase access to high-quality,
cost-effective healthcare," said Brian McEathron, GE Healthcare's
Vice President and General Manager for General Imaging Ultrasound.
"We're excited to help bring the TAEUS fatty liver product to
market and help improve patient outcomes."
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 over one
million 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
inflammation (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 news 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 commercializing the TAEUS device, receipt of U.S. Food
and Drug Administration regulatory approval, sales, if any, to be
made under distribution agreements, 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 and 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 news
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.
Company Contact:
David Wells
Chief Financial Officer
(734) 997-0464
investors@endrainc.com
www.endrainc.com
Investor Relations Contact:
Kim Sutton Golodetz
LHA Investor Relations
(212) 838-3777
kgolodetz@lhai.com
SOURCE: ENDRA Life Sciences
Inc.