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) March 25, 2021
ENDRA Life Sciences Inc.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
|
001-37969
|
|
26-0579295
|
|
(State
or other jurisdiction of incorporation)
|
|
(Commission
File Number)
|
|
(IRS
Employer Identification No.)
|
|
3600
Green Court, Suite 350 Ann Arbor, MI
|
|
48105
|
|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
|
|
|
|
|
Registrant's
telephone number, including area code
|
|
(734)
335-0468
|
|
|
|
|
(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:
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
|
Common
stock, par value $0.0001 per share
|
NDRA
|
The
Nasdaq Stock Market LLC
|
|
Warrants,
each to purchase one share of Common Stock
|
NDRAW
|
The
Nasdaq Stock Market LLC
|
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
March 25, 2021, ENDRA Life Sciences Inc. issued a press release
announcing its financial results for the quarter and year ended
December 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
|
Exhibit No.
|
|
Description
|
|
99.1
|
|
Press
Release dated March 25, 2021, furnished herewith.
|
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.
|
|
ENDRA Life Sciences Inc.
|
|
March
25, 2021
|
|
|
|
By:
|
/s/
Francois Michelon
|
|
|
Name:
|
Francois
Michelon
|
|
|
Title:
|
President
and Chief Executive Officer
|
ENDRA Life Sciences Reports 2020 Fourth Quarter and Full Year
Financial Results, Provides Business Update
Conference call begins at 4:30 p.m. Eastern time today
ANN ARBOR, Mich. (March 25, 2021) – ENDRA Life Sciences
Inc. (“ENDRA”)
(NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound
(TAEUS®),
today reported financial results for the three and twelve months
ended December 31, 2020 and provided a business update. Highlights
of the fourth quarter of 2020 and recent weeks include the
following:
●
Partnered with Hepion
Pharmaceuticals, Inc. (NASDAQ: HEPA), a clinical-stage
biopharmaceutical company focused on AI-driven therapeutic drug
development for the treatment of NASH and liver disease.
ENDRA
signed a collaboration agreement with Hepion to incorporate TAEUS
as an add-on technology to support Hepion's patient screening and
biomarker measurement during its upcoming Phase 2b study of
CRV431.
●
Secured a new clinical study
partnership with Inselspital University Hospital in Bern,
Switzerland. This is the third
clinical research partnership for ENDRA in Europe and the sixth
globally. The data from the Inselspital Bern study, along with
other ongoing or to-be-initiated studies, will be used to bolster
clinical evidence and further establish the clinical utility of the
TAEUS device for assessing Non-Alcoholic Fatty Liver Disease
(NAFLD).
●
Began screening patients for
real-world clinical validation. The first patient in a clinical study by an ENDRA
clinical research partner took place at Rocky Vista University
College of Osteopathic Medicine (“RVUCOM”). The TAEUS
system was installed at RVUCOM’s Ivins, Utah location in
November 2020 with the first patient of a targeted 200, scanned
in February 2021.
●
Strengthened TAEUS intellectual
property protection with issuance of two additional U.S. and one Chinese
patents. ENDRA’s
intellectual property portfolio continues to grow and currently
stands at 82 global assets,
defined as patents issued, filed, licensed or in
preparation.
●
Extended collaboration
agreement with GE Healthcare for two additional years.
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.
●
Strengthened balance sheet with receipt of
$18.5 million from the sale of common
stock. As previously announced
on December 18, 2020, the Company sold 7.9 million shares of common
stock for gross proceeds of $5.5 million. Subsequent to the year
end, the Company has raised an additional $10.1 million from its
at-the-market (“ATM”) offering via the sale of 3.9
million shares at a weighted average cost of $2.58 per share, and
$2.9 million from the cash exercise of approximately 3.6 million
warrants.
●
Executed first distribution
agreement for TAEUS. Quang Phat
Technology Science Equipment Co. Ltd, signed an exclusive
distribution agreement for the initial sale of up to 40 TAEUS liver
systems in Vietnam. Sales are expected to begin as soon as TAEUS
receives U.S. Food and Drug Administration (FDA) clearance and
local regulatory approvals.
"Despite the challenges related to COVID-19 we faced throughout
most of 2020, I am delighted with the progress the ENDRA team made
to advance our commercialization strategy for the TAEUS system. We
finished the year strong and are doing everything within our
control to prepare for success when the healthcare system resumes
services at pre-pandemic levels. This includes actively
communicating with the FDA regarding our 510(k) submission in
preparation for the potential clearance to begin commercialization
in the U.S.,” stated Francois Michelon, Chairman and Chief
Executive Officer of ENDRA. “At the same time, we remain
focused on gathering additional data to bolster TAEUS’
clinical utility to assess and monitor chronic liver conditions.
While unrelated to our FDA application, we believe these
independent evaluations will assist our future commercialization
efforts by documenting TAEUS’ clinical and economic value
versus MRI.”
Renaud Maloberti, Chief Commercial Officer, added, "As we
experience an improving environment with the easing of restrictions
as COVID-19 cases decrease globally, our clinical study partners
are enthusiastic to move forward with their TAEUS evaluations, a
key part of our launch strategy. In parallel, we are building our
European sales team, members of which are collaborating with GE
Healthcare and engaging with clinicians via Zoom. We believe ENDRA
is poised to begin reporting commercial sales in 2021 as we address
this significant market opportunity with a differentiated product
and compelling benefits to physicians, patients and healthcare
systems.”
Fourth Quarter 2020 Financial Results
●
Operating expenses decreased to $2.3 million in the fourth quarter of 2020, down
from $3.1 million in the same period in 2019. The
decrease was primarily due to expenses
related to the development of TAEUS as the product was
substantially completed and ready for sale.
●
Net loss in the fourth quarter of 2020 was
$2.3 million, or
($0.10) per share, compared
with a net loss of $4.8 million
in the fourth quarter of 2019.
Full Year 2020 Financial Results
●
Operating expenses increased to $11.5
million in 2020, up from $10.8
million in 2019. The increase
in general and administration expenses and sales and marketing, was
partially offset by decreased spending in research and
development.
●
Net loss in 2020 was $11.7 million, or ($0.63) per share, compared with a net
loss of $13.3 million, or
($2.34) per share, in
2019.
●
Cash was provided
through the sale of common stock for proceeds totaling $6.8 million
and the exercise of warrants for proceeds totaling $4.7 million
during 2020.
●
The Company had cash and cash equivalents of
$7.2 million as of December 31,
2020, compared with $6.2 million as of December 31, 2019, with no long-term
debt.
●
Subsequent
to December 31, 2020, the Company has received exercise notices for
3.6 million warrants resulting in additional cash proceeds of $2.9
million, as well sold approximately 3.9 million shares through its
ATM facility with Ascendiant Capital for gross proceeds of $10.1
million.
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: 888-506-0062
International: 973-528-0011
Replay Dial-in Numbers
U.S./Canada: 877-481-4010
International: 919-882-2331
Replay Passcode: 40227
The telephone replay will be available through 4:30 p.m. Eastern
time on April 1, 2021
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 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 and 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, 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
Investor Relations Contact:
Yvonne Briggs
LHA Investor Relations
(310) 691-7100
ENDRA Life Sciences Inc.
Balance Sheets
|
|
|
|
|
Assets
|
|
|
|
Current Assets
|
|
|
|
Cash
|
$7,227,316
|
$6,174,207
|
|
Prepaid
expenses
|
390,800
|
116,749
|
|
Inventory
|
589,620
|
113,442
|
|
Other
current assets
|
5,986
|
130,701
|
|
Total
Current Assets
|
8,213,722
|
6,535,099
|
|
Non-Current Assets
|
|
|
|
Fixed
assets, net
|
212,242
|
236,251
|
|
Right
of use assets
|
339,012
|
404,919
|
|
Total Assets
|
$8,764,976
|
$7,176,269
|
|
|
|
|
|
Liabilities and
Stockholders’ Equity
|
|
|
|
Current Liabilities
|
|
|
|
Accounts
payable and accrued liabilities
|
$910,183
|
$1,708,525
|
|
Convertible
notes payable, net of discount
|
-
|
298,069
|
|
Lease
liabilities, current portion
|
76,480
|
66,193
|
|
Total
Current Liabilities
|
986,663
|
2,072,787
|
|
|
|
|
|
Long Term Debt
|
|
|
|
Loans
|
337,084
|
-
|
|
Lease
liabilities
|
271,908
|
342,812
|
|
Total
Long Term Debt
|
608,992
|
342,812
|
|
|
|
|
|
Total Liabilities
|
1,595,655
|
2,415,599
|
|
|
|
|
|
Stockholders’ Equity
|
|
|
|
Preferred
stock series A, $0.0001 par value; 10,000 shares authorized;
190.288 and 6,338.490 shares issued and outstanding,
respectively
|
1
|
1
|
|
Preferred
stock series B, $0.0001 par value; 1,000 shares authorized; no
shares and 351.711 shares issued and outstanding,
respectively
|
-
|
-
|
|
Common
stock, $0.0001 par value; 80,000,000 shares authorized; 34,049,704
and 8,421,401 shares issued and outstanding,
respectively
|
3,404
|
842
|
|
Additional
paid in capital
|
64,488,558
|
49,933,736
|
|
Stock
payable
|
15,847
|
43,528
|
|
Accumulated
deficit
|
(57,338,489)
|
(45,217,437)
|
|
Total
Stockholders’ Equity
|
7,169,321
|
4,760,670
|
|
Total Liabilities and Stockholders’ Equity
|
$8,764,976
|
$7,176,269
|
ENDRA Life Sciences Inc.
Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses
|
|
|
|
Research
and development
|
$5,917,944
|
$6,574,999
|
|
Sales
and marketing
|
581,893
|
412,434
|
|
General
and administrative
|
5,002,080
|
3,856,159
|
|
Total
operating expenses
|
11,501,917
|
10,843,592
|
|
|
|
|
|
Operating
loss
|
(11,501,917)
|
(10,843,592)
|
|
|
|
|
|
Other Expenses
|
|
|
|
Amortization
of debt discount
|
(232,426)
|
(2,355,469)
|
|
Other
income (expense)
|
8,842
|
(106,903)
|
|
Total
other expenses
|
(223,584)
|
(2,462,372)
|
|
|
|
|
|
Loss
from operations before income taxes
|
(11,725,501)
|
(13,305,964)
|
|
|
|
|
|
Provision
for income taxes
|
-
|
-
|
|
|
|
|
|
Net Loss
|
$(11,725,501)
|
$(13,305,964)
|
|
|
|
|
|
Fair
value adjustment related to warrants repricing
|
(395,551)
|
-
|
|
Deemed
dividend related to preferred stock
|
-
|
(4,219,777)
|
|
|
|
|
|
Net
Loss attributable to common stockholders
|
$(12,121,052)
|
$(17,525,741)
|
|
|
|
|
|
Net loss per share – basic and diluted
|
$(0.63)
|
$(2.34)
|
|
|
|
|
|
Weighted average common shares – basic and
diluted
|
19,192,226
|
7,499,984
|
ENDRA Life Sciences Inc.
Statement of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Operating Activities
|
|
|
|
Net
loss
|
$(11,725,501)
|
$(13,305,964)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation
and amortization
|
99,342
|
80,577
|
|
Common
stock, options and warrants issued for services
|
2,102,353
|
1,399,547
|
|
Amortization
of debt discount
|
232,426
|
2,355,469
|
|
Impairment
of other assets
|
-
|
249,256
|
|
Amortization
of right of use assets
|
65,907
|
34,434
|
|
Changes
in operating assets and liabilities:
|
|
|
|
Increase
in prepaid expenses
|
(274,051)
|
28,675
|
|
Decrease
in lease liability
|
(60,617)
|
(30,348)
|
|
Increase
in inventory
|
(476,178)
|
(53,998)
|
|
Decrease
in Other Current Assets
|
124,715
|
(106,642)
|
|
Decrease
in accounts payable and accrued liabilities
|
(858,991)
|
760,143
|
|
Net
cash used in operating activities
|
(10,770,595)
|
(8,588,851)
|
|
|
|
|
|
Cash Flows from Investing Activities
|
|
|
|
Purchases
of fixed assets
|
(51,333)
|
(43,595)
|
|
Net
cash used in investing activities
|
(51,333)
|
(43,595)
|
|
|
|
|
|
Cash Flows from Financing Activities
|
|
|
|
Proceeds
from senior secured convertible promissory notes, net of
fees
|
-
|
2,490,501
|
|
Proceeds
from issuance of Series A Convertible Preferred Stock
|
-
|
5,344,257
|
|
Proceeds
from issuance of Series B Convertible Preferred Stock
|
-
|
375,520
|
|
Proceeds
from warrant exercise
|
4,757,011
|
-
|
|
Proceeds
from loans
|
337,084
|
-
|
|
Proceeds
from issuance of common stock
|
6,780,942
|
125,000
|
|
Net
cash provided by financing activities
|
11,875,037
|
8,335,278
|
|
|
|
|
|
Net
decrease in cash
|
1,053,109
|
(297,168)
|
|
|
|
|
|
Cash,
beginning of period
|
6,174,207
|
6,471,375
|
|
|
|
|
|
Cash, end of period
|
$7,227,316
|
$6,174,207
|
|
|
|
|
|
Supplemental
disclosures of cash items
|
|
|
|
Interest
paid
|
$1,920
|
$-
|
|
Income
tax paid
|
$-
|
$-
|
|
|
|
|
|
Supplemental
disclosures of non-cash items
|
|
|
|
Discount
on convertible notes
|
$-
|
$2,490,501
|
|
Conversion
of convertible notes and accrued interest
|
$493,814
|
$140,406
|
|
Exchange
of balance in convertible notes and accrued interest for Series A
preferred stock
|
$-
|
$1,943,195
|
|
Deemed
dividend
|
$395,551
|
$4,219,777
|
|
Conversion
of Series A Convertible Preferred Stock
|
$(717)
|
$-
|
|
Conversion
of Series B Convertible Preferred Stock
|
$(36)
|
$-
|
|
Stock
dividend payable
|
$(49,649)
|
$-
|
|
Right
of use asset
|
$339,012
|
$404,919
|
|
Lease
liability
|
$348,388
|
$409,005
|
# # #