ENDRA Life Sciences Inc. - Quarter Report: 2020 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR
THE QUARTERLY PERIOD ENDED JUNE 30, 2020
OR
☐ TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
COMMISSION FILE NUMBER 001-37969
ENDRA LIFE SCIENCES INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
|
26-0579295
|
(State of incorporation)
|
|
(I.R.S. Employer Identification No.)
|
3600 Green Court, Suite 350, Ann Arbor, MI 48105-1570
(Address of principal executive
office) ( Zip
code )
(734) 335-0468
(Registrant’s telephone number, including area
code)
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 (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such
shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check
mark whether the registrant has submitted electronically every
Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the
preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate by check
mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, smaller reporting
company or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated
filer,” “smaller reporting company” and
“emerging growth company” in Rule 12b-2 of the
Exchange Act:
Large
accelerated filer
|
☐
|
Accelerated
filer
|
☐
|
Non-accelerated
filer
|
☒
|
Smaller
reporting company
|
☒
|
|
|
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. ☐
Indicate by check mark whether the registrant is a
shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☒
As of August 13, 2020, there were
20,960,993 shares of
our common stock, par value $0.0001 per share,
outstanding.
TABLE OF CONTENTS
|
|
Page
|
PART
I - FINANCIAL INFORMATION
|
|
|
|
|
|
Item
1.
|
Condensed
Consolidated Financial Statements (unaudited)
|
4
|
|
|
|
|
Condensed
Consolidated Balance Sheets – June 30, 2020 (unaudited) and
December 31, 2019
|
4
|
|
|
|
|
Condensed
Consolidated Statements of Operations – Three and six months
ended June 30, 2020 and 2019 (unaudited)
|
5
|
|
|
|
|
Condensed
Consolidated Statements of Equity (Deficit) as of June 30, 2020 and
2019 (unaudited)
|
6
|
|
|
|
|
Condensed
Consolidated Statements of Cash Flows – Six months ended June
30, 2020 and 2019 (unaudited)
|
8
|
|
|
|
|
Notes
to the Condensed Consolidated Financial Statements
(unaudited)
|
9
|
|
|
|
Item 2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
21
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
28
|
|
|
|
Item
4.
|
Controls
and Procedures
|
28
|
|
|
|
PART II - OTHER INFORMATION
|
||
|
|
|
Item
1.
|
Legal
Proceedings
|
29
|
|
|
|
Item1A.
|
Risk
Factors
|
29
|
|
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
30
|
|
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
30
|
|
|
|
Item
4.
|
Mine
Safety Disclosure
|
30
|
|
|
|
Item
5.
|
Other
Information
|
30
|
|
|
|
Item
6.
|
Exhibits
|
31
|
|
|
|
|
Signatures
|
32
|
3
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
ENDRA Life Sciences Inc.
Condensed Consolidated Balance Sheets
|
June
30,
|
December
31,
|
Assets
|
2020
|
2019
|
Assets
|
(unaudited)
|
|
Cash
|
$748,561
|
$6,174,207
|
Prepaid
expenses
|
1,064,146
|
116,749
|
Inventory
|
340,687
|
113,442
|
Other current
assets
|
121,951
|
130,701
|
Total Current
Assets
|
2,275,345
|
6,535,099
|
Other
Assets
|
|
|
Fixed assets,
net
|
214,587
|
236,251
|
Right of use
assets
|
372,720
|
404,919
|
Total
Assets
|
$2,862,652
|
$7,176,269
|
|
|
|
Liabilities
and Stockholders’ Equity
|
|
|
Current
Liabilities
|
|
|
Accounts payable
and accrued liabilities
|
$1,169,237
|
$1,708,525
|
Convertible notes
payable, net of discount
|
-
|
298,069
|
Lease liabilities,
current portion
|
71,085
|
66,193
|
Total Current
Liabilities
|
1240,322
|
2,072,787
|
|
|
|
Long
Term Debt
|
|
|
Loans
|
337,084
|
-
|
Lease
liabilities
|
308,366
|
342,812
|
Total Long Term
Debt
|
645,450
|
342,812
|
|
|
|
Total
Liabilities
|
1,885,772
|
2,415,599
|
|
|
|
Stockholders’
Equity
|
|
|
Series A
Preferred
Stock , $0.0001 par value; 10,000 shares authorized; 896.225
and 6,338.490 shares issued and outstanding
|
1
|
1
|
Series B
Preferred
Stock, $0.0001 par value; 1,000 shares authorized; 0 and
351.711 shares issued and outstanding
|
-
|
-
|
Common stock,
$0.0001 par value; 80,000,000 shares authorized; 16,437,491 and
8,421,401 shares issued and outstanding
|
1,644
|
842
|
Additional paid in
capital
|
52,227,904
|
49,933,736
|
Stock
payable
|
181,437
|
43,528
|
Accumulated
deficit
|
(51,434,106)
|
(45,217,437)
|
Total
Stockholders’ Equity
|
976,880
|
4,760,670
|
Total
Liabilities and Stockholders’ Equity
|
$2,862,652
|
$7,176,269
|
The
accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
4
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
|
Three Months
Ended
|
Three Months
Ended
|
Six Months
Ended
|
Six Months
Ended
|
|
June
30,
|
June
30,
|
June
30,
|
June
30,
|
|
2020
|
2019
|
2020
|
2019
|
Operating
Expenses
|
|
|
|
|
Research and
development
|
$1,487,049
|
$1,304,808
|
$3,005,195
|
$3,078,306
|
Sales and
marketing
|
134,763
|
88,343
|
249,718
|
145,161
|
General and
administrative
|
1,269,467
|
932,021
|
2,737,212
|
1,848,924
|
Total operating
expenses
|
2,891,279
|
2,325,172
|
5,992,125
|
5,072,391
|
|
|
|
|
|
Operating
loss
|
(2,891,279)
|
(2,325,172)
|
(5,992,125)
|
(5,072,391)
|
|
|
|
|
|
Other
Expenses
|
|
|
|
|
Amortization of
debt discount
|
(3,858)
|
-
|
(232,426)
|
-
|
Other income
(expense)
|
1,265
|
(9,199)
|
7,882
|
(10,716)
|
Total other
expenses
|
(2,593)
|
(9,199)
|
(224,544)
|
(10,716)
|
|
|
|
|
|
Loss from
operations before income taxes
|
(2,893,872)
|
(2,334,371)
|
(6,216,669)
|
(5,083,107)
|
|
|
|
|
|
Provision for
income taxes
|
-
|
-
|
-
|
-
|
|
|
|
|
|
Net
Loss
|
$(2,893,872)
|
$(2,334,371)
|
$(6,216,669)
|
$(5,083,107)
|
|
|
|
|
|
Net
loss per share – basic and diluted
|
$(0.20)
|
$(0.31)
|
$(0.45)
|
$(0.68)
|
|
|
|
|
|
Weighted
average common shares – basic and diluted
|
14,735,662
|
7,422,642
|
13,803,215
|
7,422,642
|
The
accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
5
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Stockholders’
Equity
(Unaudited)
Three Months Ended June 30, 2019
|
Series A
Convertible
|
Series B
Convertible
|
|
|
|
|
|
Total
|
||
|
Preferred
Stock
|
Preferred
Stock
|
Common
stock
|
Additional
|
|
Accumulated
|
Stockholders'
|
|||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Paid in
Capital
|
Stock
Payable
|
Deficit
|
Equity
|
Balance as of
March 31, 2019
|
-
|
$-
|
-
|
$-
|
7,422,642
|
$742
|
$34,241,430
|
$-
|
$(30,440,432)
|
$3,801,740
|
Fair value of vested stock
options
|
-
|
-
|
-
|
-
|
-
|
-
|
356,949
|
-
|
-
|
356,949
|
Net loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(2,334,372)
|
(2,334,372)
|
Balance as of
June 30, 2019
|
-
|
$-
|
-
|
$-
|
7,422,642
|
$742
|
$34,598,379
|
$-
|
$(32,774,804)
|
$1,824,317
|
Three Months Ended June 30, 2020
|
Series A
Convertible
|
Series B
Convertible
|
|
|
|
|
|
Total
|
||
|
Preferred
Stock
|
Preferred
Stock
|
Common
stock
|
Additional
|
|
Accumulated
|
Stockholders'
|
|||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Paid in
Capital
|
Stock
Payable
|
Deficit
|
Equity
|
Balance as of
March 31, 2020
|
2,442.920
|
$1
|
121.578
|
$-
|
13,553,005
|
$1,355
|
$50,982,080
|
$78,836
|
$(48,540,234)
|
$2,522,038
|
Series A Convertible Preferred
Stock converted to common stock
|
(1,545.695)
|
-
|
-
|
-
|
1,840,821
|
184
|
37,817
|
(38,001)
|
-
|
-
|
Series B Convertible Preferred
Stock converted to common stock
|
-
|
-
|
(121.578)
|
-
|
126,199
|
13
|
822
|
(835)
|
-
|
-
|
Common stock issued for
cash
|
-
|
-
|
-
|
-
|
882,493
|
88
|
791,386
|
-
|
-
|
791,474
|
Common stock issued for warrant
exercise
|
-
|
-
|
-
|
-
|
12,874
|
2
|
11,198
|
-
|
-
|
11,200
|
Common stock issued for
services
|
-
|
-
|
-
|
-
|
22,099
|
2
|
39,998
|
(40,000)
|
-
|
-
|
Fair value of vested stock
options
|
-
|
-
|
-
|
-
|
-
|
-
|
402,946
|
-
|
-
|
402,946
|
Stock Payable towards
-
|
|
|
|
|
|
|
|
|
|
|
- Preference
Dividend
|
-
|
-
|
-
|
-
|
-
|
-
|
(11,043)
|
11,043
|
-
|
-
|
- Consultants
|
-
|
-
|
-
|
-
|
-
|
-
|
(27,300)
|
27,300
|
-
|
-
|
- RSUs to board and
management
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
143,094
|
-
|
143,094
|
Net loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(2,893,872)
|
(2,893,872)
|
Balance as of
June 30, 2020
|
896.225
|
$1
|
-
|
$-
|
16,437,491
|
$1,644
|
$52,227,904
|
$181,437
|
$(51,434,106)
|
$976,880
|
6
Six Months Ended June 30, 2019
|
Series A
Convertible
|
Series B
Convertible
|
|
|
|
|
|
Total
|
||
|
Preferred
Stock
|
Preferred
Stock
|
Common
stock
|
Additional
|
|
Accumulated
|
Stockholders'
|
|||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Paid in
Capital
|
Stock
Payable
|
Deficit
|
Equity
|
Balance as of
December 31, 2018
|
-
|
$-
|
-
|
$-
|
7,422,642
|
$742
|
$33,939,162
|
$-
|
$(27,691,696)
|
$6,248,208
|
Fair value of vested stock
options
|
-
|
-
|
-
|
-
|
-
|
-
|
659,217
|
-
|
-
|
659,217
|
Net loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(5,083,107)
|
(5,083,107)
|
Balance as of
June 30, 2019
|
-
|
$-
|
-
|
$-
|
7,422,642
|
$742
|
$34,598,379
|
$-
|
$(32,774,803)
|
$1,824,318
|
Six Months Ended June 30, 2020
|
Series A
Convertible
|
Series B
Convertible
|
|
|
|
|
|
Total
|
||
|
Preferred
Stock
|
Preferred
Stock
|
Common
stock
|
Additional
|
|
Accumulated
|
Stockholders'
|
|||
|
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Paid in
Capital
|
Stock
Payable
|
Deficit
|
Equity
|
Balance as of
December 31, 2019
|
6,338.490
|
$1
|
351.711
|
$-
|
8,421,401
|
$842
|
$49,933,736
|
$43,528
|
$(45,217,437)
|
$4,760,670
|
Series A Convertible Preferred
Stock converted to common stock
|
(5,442.265)
|
-
|
-
|
-
|
6,361,803
|
636
|
75,288
|
(75,924)
|
-
|
-
|
Series B Convertible Preferred
Stock converted to common stock
|
-
|
-
|
351.711
|
-
|
360,279
|
36
|
1,634
|
(1,670)
|
-
|
-
|
Common stock issued for
cash
|
-
|
-
|
-
|
-
|
882,493
|
88
|
791,386
|
-
|
-
|
791,474
|
Common stock issued for note
conversions
|
-
|
-
|
-
|
-
|
331,441
|
33
|
493,814
|
-
|
-
|
493,847
|
Common stock issued for warrant
exercise
|
-
|
-
|
-
|
-
|
57,975
|
7
|
50,431
|
-
|
-
|
50,438
|
Common stock issued for
services
|
-
|
-
|
-
|
-
|
22,099
|
2
|
39,998
|
-
|
-
|
40,000
|
Fair value of vested stock
options
|
-
|
-
|
-
|
-
|
-
|
-
|
914,026
|
-
|
-
|
914,026
|
Stock Payable towards
-
|
|
|
|
|
|
|
|
|
|
|
- Preference
Dividend
|
-
|
-
|
-
|
-
|
-
|
-
|
(45,109)
|
45,109
|
-
|
-
|
- Consultants
|
-
|
-
|
-
|
-
|
-
|
-
|
(27,300)
|
27,300
|
-
|
-
|
- RSU to board and
management
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
143,094
|
-
|
143,094
|
Net loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(6,216,669)
|
(6,216,669)
|
Balance as of
June 30, 2020
|
896.225
|
$1
|
-
|
$-
|
16,437,491
|
$1,644
|
$52,227,904
|
$181,437
|
$(51,434,106)
|
$976,880
|
The
accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
7
ENDRA Life Sciences Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
Six
Months Ended
|
Six
Months Ended
|
|
June
30,
|
June
30,
|
|
2020
|
2019
|
Cash
Flows from Operating Activities
|
|
|
Net
loss
|
$(6,216,669)
|
$(5,083,107)
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation and
amortization
|
44,014
|
39,744
|
Common stock,
options and warrants issued for services
|
1,057,120
|
659,217
|
Amortization of
debt discount
|
232,426
|
|
Amortization of
right of use assets
|
32,199
|
|
Changes in
operating assets and liabilities:
|
|
|
Prepaid
expenses
|
(947,397)
|
(98,358)
|
Lease
liability
|
(29,554)
|
|
Inventory
|
(227,245)
|
(14,837)
|
Other
assets
|
8,750
|
(93,075)
|
Accounts payable
and accrued liabilities
|
(493,676)
|
391,809
|
Net cash used in
operating activities
|
(6,540,032)
|
(4,198,607)
|
|
|
|
Cash
Flows from Investing Activities
|
|
|
Purchases of fixed
assets
|
(22,350)
|
(5,238)
|
Net cash used in
investing activities
|
(22,350)
|
(5,238)
|
|
|
|
Cash
Flows from Financing Activities
|
|
|
Proceeds from
warrant exercise
|
50,438
|
-
|
Proceeds from
loans
|
337,084
|
-
|
Proceeds from
issuance of common stock
|
791,474
|
-
|
Payment for
settlement of notestock
|
(42,260)
|
-
|
|
|
|
Net cash provided
by financing activities
|
1,136,736
|
-
|
|
|
|
Net decrease in
cash
|
(5,425,646)
|
(4,203,845)
|
|
|
|
Cash, beginning of
period
|
6,174,207
|
6,471,375
|
|
|
|
Cash,
end of period
|
$748,561
|
$2,267,530
|
|
|
|
Supplemental
disclosures of cash items
|
|
|
Interest
paid
|
$1,920
|
$-
|
|
|
|
Supplemental
disclosures of non-cash items
|
|
|
Conversion of
convertible notes and accrued interest
|
$493,814
|
$-
|
Conversion of
Series A Convertible Preferred Stock
|
$636
|
$-
|
Conversion of
Series B Convertible Preferred Stock
|
$36
|
$-
|
Stock dividend
payable
|
$(137,909)
|
$-
|
Stock paid and
payable for services
|
$40,000
|
$-
|
Lease liability for
right of use asset at inception
|
$-
|
$439,355
|
The
accompanying notes are an integral part of these unaudited
condensed consolidated financial statements.
8
ENDRA Life Sciences Inc.
Notes to Condensed Consolidated Financial Statements
For the six months ended June 30, 2020 and 2019
(Unaudited)
Note 1 – Nature of the Business
ENDRA Life Sciences Inc. (“ENDRA” or the
“Company”) has developed and is continuing to develop
technology for increasing the capabilities of clinical diagnostic
ultrasound, to broaden patient access to the safe diagnosis and
treatment of a number of significant medical conditions in
circumstances where expensive X-ray computed tomography
(“CT”) and magnetic resonance imaging
(“MRI”) technology is unavailable or
impractical.
ENDRA was incorporated on July 18, 2007 as a Delaware
corporation.
ENDRA Life Sciences Canada Inc. was organized under the laws of
Ontario, Canada on July 6, 2017, and is wholly owned by the
Company.
Note 2 – Summary of Significant Accounting
Policies
Use of Estimates
The preparation of the financial statements in conformity with
accounting principles generally accepted in the United States
requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities, and disclosure of
contingent liabilities at the date of the financial statements and
the reported amounts of expenses during the reporting period.
Actual results could differ from those estimates.
Management makes estimates that affect certain accounts including
deferred income tax assets, accrued expenses, fair value of equity
instruments and reserves for any other commitments or
contingencies. Any adjustments applied to estimates are recognized
in the period in which such adjustments are
determined.
The COVID-19 outbreak, which the World Health Organization has
classified as a pandemic, has prompted governments and regulatory
bodies throughout the world to issue “stay-at-home” or
similar orders, and enact restrictions on the performance of
“non-essential” services, public gatherings and
travel.
The extent to which COVID-19 impacts the Company’s business
and financial results will depend on numerous evolving factors
including, but not limited to: the magnitude and duration of
COVID-19, the extent to which it will impact worldwide
macroeconomic conditions, the speed of the anticipated recovery,
access to capital markets, and governmental and business reactions
to the pandemic. The Company assessed certain accounting matters
that generally require consideration of forecasted financial
information in context with the information reasonably available to
the Company and the unknown future impacts of COVID-19 as of June
30, 2020 and through the date of the filing of this Quarterly
Report on Form 10-Q. The accounting matters assessed included, but
were not limited to estimates related to the accounting for
potential liabilities and accrued expenses, the assumptions
utilized in valuing stock-based compensation issued for services,
the realization of deferred tax assets, and assessments of
impairment related to long-lived assets. The Company’s future
assessment of the magnitude and duration of COVID-19, as well as
other factors, could result in additional material impacts to the
Company’s consolidated financial statements in future
reporting periods.
Despite the Company’s efforts, the ultimate impact of
COVID-19 depends on factors beyond the Company’s knowledge or
control, including the duration and severity of the outbreak, as
well as third-party actions taken to contain its spread and
mitigate its public health effects. As a result, the Company is
unable to estimate the extent to which COVID-19 will negatively
impact its financial results or liquidity.
Principles of Consolidation
The Company’s consolidated financial statements include all
accounts of the Company and its consolidated subsidiary and/or
entities as of reporting period ending date(s) and for the
reporting period(s) then ended. All inter-company balances and
transactions have been eliminated.
9
Basis of Presentation
The accompanying unaudited condensed consolidated financial
statements and related notes have been prepared pursuant to the
rules and regulations of the Securities and Exchange Commission
(the “SEC”). Accordingly, certain information and
footnote disclosures normally included in financial statements
prepared in accordance with generally accepted accounting
principles have been omitted pursuant to such rules and
regulations. In the opinion of management, all adjustments
(consisting of normal recurring accruals) considered necessary for
a fair presentation have been included. Operating results for the
six months ended June 30, 2020 are not necessarily indicative of
the results that may be expected for the year ended December 31,
2020. The balance sheet at December 31, 2019 has been derived from
the audited financial statements at that date. For further
information, refer to the financial statements and footnotes
thereto included in ENDRA Life Sciences Inc. annual financial
statements for the twelve months ended December 31, 2019 included
in the Company’s Annual Report on Form 10-K filed with the
SEC on March 26, 2020.
Cash and Cash Equivalents
The Company considers all cash on hand and in banks, including
accounts in book overdraft positions, certificates of deposit and
other highly-liquid investments with maturities of one year or
less, when purchased, to be cash. As of June 30, 2020 and December
31, 2019, the Company had no cash equivalents. The Company
maintains its cash in bank deposit accounts which, at times, may
exceed federally insured limits. The Company has not experienced
any losses in such accounts and periodically evaluates the credit
worthiness of the financial institutions and has determined the
credit exposure to be negligible.
Inventory
The Company’s inventory is stated at the lower of cost or
estimated net realizable value, with cost primarily determined on a
weighted-average cost basis on the first-in, first-out method. The
Company periodically determines whether a reserve should be taken
for devaluation or obsolescence of inventory.
Capitalization of Fixed Assets
The Company capitalizes expenditures related to property and
equipment, subject to a minimum rule, that have a useful life
greater than one year for: (1) assets purchased; (2) existing
assets that are replaced, improved or the useful lives have been
extended; or (3) all land, regardless of cost. Acquisitions of new
assets, additions, replacements and improvements (other than land)
costing less than the minimum rule in addition to maintenance and
repair costs, including any planned major maintenance activities,
are expensed as incurred.
Leases
In February 2016, the Financial Accounting Standards Board
(“FASB”) issued ASU No. 2016-02, “Leases.”
ASU 2016-02 requires a lessee to record a right of use asset and a
corresponding lease liability on the balance sheet for all leases
with terms longer than 12 months. ASU 2016-02 is effective for all
interim and annual reporting periods beginning after December 15,
2018. Early adoption is permitted. A modified retrospective
transition approach is required for lessees for capital and
operating leases existing at, or entered into after, the beginning
of the earliest period presented in the financial statements. At
June 30, 2020 and December 31, 2019 the Company recorded a
liability of $379,451 and $409,005, respectively.
Revenue Recognition
In May 2014, the FASB issued Accounting Standards Update
(“ASU”) No. 2014-09, “Revenue from Contracts with
Customers” (“ASC Topic 606”). This standard
provides a single set of guidelines for revenue recognition to be
used across all industries and requires additional disclosures. The
updated guidance introduces a five-step model to achieve its core
principal of the entity recognizing revenue to depict the transfer
of goods or services to customers at an amount that reflects the
consideration to which the entity expects to be entitled in
exchange for those goods or services. The Company adopted the
updated guidance effective January 1, 2018 using the full
retrospective method. The new standard did not have a material
impact on its financial position and results of operations, as it
did not change the manner or timing of recognizing
revenue.
Under ASC Topic 606, in order to recognize revenue, the Company is
required to identify an approved contract with commitments to
perform respective obligations, identify rights of each party in
the transaction regarding goods to be transferred, identify the
payment terms for the goods transferred, verify that the contract
has commercial substance and verify that collection of
substantially all consideration is probable. The adoption of ASC
Topic 606 did not have an impact on the Company’s operations
or cash flows.
Research and Development Costs
The Company follows FASB Accounting Standards Codification
(“ASC”) Subtopic 730-10, “Research and
Development”. Research and development costs are charged to
the statement of operations as incurred. During the six months
ended June 30, 2020 and 2019, the Company incurred $3,005,195 and
$3,078,306 of expenses related to research and development costs,
respectively.
10
Net Earnings (Loss) Per Common Share
The Company computes earnings per share under ASC Subtopic 260-10,
“Earnings Per Share”. Basic earnings (loss) per share
is computed by dividing the net income (loss) attributable to the
common stockholders (the numerator) by the weighted average number
of shares of common stock outstanding (the denominator) during the
reporting periods. Diluted loss per share is computed by increasing
the denominator by the weighted average number of additional shares
that could have been outstanding from securities convertible into
common stock (using the “treasury stock” method),
unless their effect on net loss per share is anti-dilutive. There
were 1,030,144 and
24,949,725 potentially
dilutive shares, which include shares of common stock issuable upon
the exercise or conversion of outstanding preferred stock, stock
options, warrants, and convertible notes, as of June 30, 2020
and December 31, 2019, respectively.
The potentially dilutive shares, which are excluded from the
determination of basic and diluted net loss per share as their
effect is anti-dilutive, are as follows:
|
June 30,
2020
|
December 31,
2019
|
Options to purchase
common stock
|
3,575,775
|
3,449,319
|
Warrants to
purchase common stock
|
13,323,699
|
13,496,924
|
Shares issuable
upon conversion of notes
|
-
|
362,568
|
Shares issuable
upon conversion of Series A Preferred Stock
|
1,030,144
|
7,285,651
|
Shares issuable
upon conversion of Series B Preferred Stock
|
-
|
355,263
|
Potentially
dilutive shares excluded
|
17,929,618
|
24,949,725
|
Fair Value Measurements
Disclosures about fair value of financial instruments require
disclosure of the fair value information, whether or not recognized
in the balance sheet, where it is practicable to estimate that
value.
In accordance with ASC Topic 820, “Fair Value Measurements
and Disclosures,” the Company measures certain financial
instruments at fair value on a recurring basis. ASC Topic 820
defines fair value, established a framework for measuring fair
value in accordance with accounting principles generally accepted
in the United States, and expands disclosures about fair value
measurements.
Fair value is defined as the price that would be received to sell
an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. ASC Topic 820
established a three-tier fair value hierarchy, which prioritizes
the inputs used in measuring fair value. The hierarchy gives the
highest priority to unadjusted quoted prices in active markets for
identical assets or liabilities (Level 1 measurements) and the
lowest priority to unobservable inputs (Level 3 measurements).
These tiers include:
● Level 1, defined as
observable inputs such as quoted prices for identical instruments
in active markets;
● Level 2, defined as
inputs other than quoted prices in active markets that are either
directly or indirectly observable such as quoted prices for similar
instruments in active markets or quoted prices for identical or
similar instruments in markets that are not active;
and
● Level 3, defined as
unobservable inputs in which little or no market data exists,
therefore requiring an entity to develop its own assumptions, such
as valuations derived from valuation techniques in which one or
more significant inputs or significant value drivers are
unobservable.
Financial assets are considered Level 3 when their fair values are
determined using pricing models, discounted cash flow methodologies
or similar techniques and at least one significant model assumption
or input is unobservable.
The carrying amounts of the Company’s financial assets and
liabilities, including cash, accounts receivable, prepaid expenses,
accounts payable, accrued expenses, and other current liabilities,
approximate their fair values because of the short maturity of
these instruments. The fair value of notes payable and convertible
notes approximates their fair values since the current interest
rates and terms on these obligations are the same as prevailing
market rates.
11
Share-based Compensation
The Company’s 2016 Omnibus Incentive Plan (the “Omnibus
Plan”) permits the grant of stock options and other
share-based awards to its employees, consultants and non-employee
members of the board of directors. Each January 1 the pool of
shares available for issuance under the Omnibus Plan automatically
increases by an amount equal to the lesser of (i) the number of
shares necessary such that the aggregate number of shares available
under the Omnibus Plan equals 25% of the number of fully-diluted
outstanding shares on the increase date (assuming the conversion of
all outstanding shares of preferred stock and other outstanding
convertible securities and exercise of all outstanding options and
warrants to purchase shares) and (ii) if the board of directors
takes action to set a lower amount, the amount determined by the
board. On January 1, 2020, the pool of shares issuable under the
Omnibus Plan automatically increased by 3,202,280 shares from
2,649,378 shares to 5,861,658. As of June 30, 2020, there were
2,285,883 shares of common stock remaining available for issuance
under the Omnibus Plan.
The Company records share-based compensation in accordance with the
provisions of the Share-based Compensation Topic of the FASB
Codification. The guidance requires the use of option-pricing
models that require the input of highly subjective assumptions,
including the option’s expected life and the price volatility
of the underlying stock. The fair value of each option grant is
estimated on the date of grant using the Black-Scholes option
valuation model, and the resulting charge is expensed using the
straight-line attribution method over the vesting
period.
Stock compensation expense recognized during the period is based on
the value of share-based awards that were expected to vest during
the period adjusted for estimated forfeitures. The estimated fair
value of grants of stock options and warrants to non-employees of
the Company is charged to expense, if applicable, in the financial
statements. These options vest in the same manner as the employee
options granted under the stock incentive plan as described
above.
Debt Discount
The Company determines if its outstanding convertible promissory
notes should be accounted for as liability or equity under ASC
Topic 480, “Liabilities — Distinguishing Liabilities
from Equity.” ASC Topic 480 applies to certain contracts
involving a company’s own equity, and requires that issuers
classify the following freestanding financial instruments as
liabilities: mandatorily redeemable financial instruments,
obligations that require or may require repurchase of the
issuer’s equity shares by transferring assets (e.g., written
put options and forward purchase contracts), and certain
obligations where at inception the monetary value of the obligation
is based solely or predominantly on:
● A fixed monetary amount known at inception (for example, a
payable settleable with a variable number of the issuer’s
equity shares with an issuance date fair value equal to a fixed
dollar amount);
● Variations in something other than the fair value of the
issuer’s equity shares (for example, a financial instrument
indexed to the S&P 500 and settleable with a variable number of
the issuer’s equity shares); or
● Variations inversely related to changes in the fair value
of the issuer’s equity shares (for example, a written put
that could be net share settled).
Beneficial Conversion Feature
If the
conversion feature of conventional convertible debt provides for a
rate of conversion that is below market value on the date of
issuance, this feature is characterized as a beneficial conversion
feature (“BCF”). A BCF is recorded by the Company as a
debt discount pursuant to ASC Topic 470-20 “Debt with
Conversion and Other Options.” In those circumstances, the
convertible debt is recorded net of the discount related to the BCF
and the Company amortizes the discount to interest expense over the
life of the debt using the effective interest method.
If the Company determines the instrument meets the guidance under
ASC Topic 480, the instrument is accounted for as a liability with
a respective debt discount. The Company has previously recorded
debt discounts in connection with raising funds through the
issuance of promissory notes. These costs are amortized to noncash
interest expense over the life of the debt. If a conversion of the
underlying debt occurs, a proportionate share of the unamortized
amounts is immediately expensed. See Note 6, Convertible Notes, for
further discussion on the Company’s accounting treatment for
the convertible notes.
Going Concern
The
Company’s financial statements are prepared using accounting
principles generally accepted in the United States (“U.S.
GAAP”) applicable to a going concern, which contemplates the
realization of assets and liquidation of liabilities in the normal
course of business. The Company has limited commercial experience
and had a cumulative net loss from inception to June 30, 2020 of
$51,434,106. The Company had working capital of $1,035,023 as of
June 30, 2020. The Company has not established an ongoing source of
revenue sufficient to cover its operating costs and to allow it to
continue as a going concern. The accompanying financial statements
for the period ended June 30, 2020 have been prepared assuming the
Company will continue as a going concern. The Company’s cash
resources will likely be insufficient to meet its anticipated needs
during the next twelve months. The Company will require additional
financing to fund its future planned operations, including research
and development and commercialization of its products.
12
The
ability of the Company to continue as a going concern is dependent
on the Company obtaining adequate capital to fund operating losses
until it establishes a revenue stream and becomes profitable.
Management’s plans to continue as a going concern include
raising additional capital through sales of equity securities and
borrowing. However, management cannot provide any assurances that
the Company will be successful in accomplishing any of its plans.
As described further below under “Item 2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations” the COVID-19 pandemic has impacted our business
operations to some extent and is expected to continue to do so and,
in light of the effect of such pandemic on financial markets, these
impacts may include reduced access to capital. If the Company is
not able to obtain the necessary additional financing on a timely
basis, the Company will be required to delay, reduce the scope of
or eliminate one or more of the Company’s research and
development activities or commercialization efforts or perhaps even
cease the operation of its business. The ability of the Company to
continue as a going concern is dependent upon its ability to
successfully secure other sources of financing and attain
profitable operations. There is substantial doubt about the ability
of the Company to continue as a going concern for one year from the
issuance of the accompanying consolidated financial statements. The
accompanying consolidated financial statements do not include any
adjustments that might be necessary if the Company is unable to
continue as a going concern.
Recent Accounting Pronouncements
Note 3 – Inventory
As of June 30, 2020 and December 31, 2019, inventory consisted of
raw materials and subassemblies to be used in the assembly of a
TAEUS system. As of June 30, 2020, the Company had no orders
pending for the sale of a TAEUS system. As of June 30, 2020 and December 31,
2019, the Company had inventory valued at
$340,687 and $113,442, respectively.
Note 4 – Fixed Assets
As of
June 30, 2020 and December 31, 2019, fixed assets consisted of the
following:
|
June
30,
2020
|
December
31,
2019
|
Property, leasehold
and capitalized software
|
$684,418
|
$679,179
|
TAEUS development
and testing
|
60,708
|
43,596
|
Accumulated
depreciation
|
(530,539)
|
(486,524)
|
Fixed assets,
net
|
$214,587
|
$236,251
|
Depreciation
expense for the six months ended June 30, 2020 and 2019 was $44,014
and $39,744, respectively.
13
Note 5 – Accounts Payable and Accrued
Liabilities
As of
June 30, 2020 and December 31, 2019, current liabilities consisted
of the following:
|
June
30,
2020
|
December
31,
2019
|
Accounts
payable
|
$495,319
|
$1,278,431
|
Accrued
payroll
|
159,435
|
94,862
|
Accrued
bonuses
|
194,227
|
295,794
|
Accrued employee
benefits
|
5,750
|
5,750
|
Accrued
interest
|
-
|
9,738
|
Insurance premium
financing
|
314,506
|
23,950
|
Total
|
$1,169,237
|
$1,708,525
|
Note 6 – Convertible Notes
July 2019 Notes
On July 26, 2019 the Company conducted a private placement offering
in which the Company sold senior secured convertible promissory
notes (the “July 2019 Notes”) and warrants exercisable
for shares of the Company’s common stock (the “July
2019 Warrants”) to accredited investors for a purchase price
approximately $2.8 million. The purchase price covered the purchase
of $2,587,895 aggregate principal amount of July 2019 Notes and
July 2019 Warrants exercisable for an aggregate of 1,736,843 shares
of common stock. The net proceeds to the Company were approximately
$2.5 million, after deducting placement agent fees and other
offering expenses.
The Company sold the July 2019 Notes and July 2019 Warrants
pursuant to a Securities Purchase Agreement, dated July 26, 2019,
between the Company and each purchaser. The July 2019 Notes bore
interest at a rate of 10% per annum until maturity on April 26,
2020. Interest was paid in arrears on the outstanding principal
amount on the three month anniversary of the issuance of the July
2019 Notes, and each three month period thereafter, and finally on
the maturity date. Holders of July 2019 Notes were entitled to
convert principal and accrued, unpaid interest on the July 2019
Notes into shares of common stock. The July 2019 Notes were
convertible into common stock at a conversion price per share equal
to $1.49 and were initially convertible into 1,736,843 shares of
common stock.
Each July 2019 Warrant entitles the holder to purchase one share of
common stock for an exercise price per share equal to $1.49. The
July 2019 Warrants are exercisable for an aggregate of 1,736,843
shares of common stock commencing immediately upon issuance and
expire July 26, 2022. The July 2019 Warrants provide for cashless
exercise and customary anti-dilution protection. The terms of the
Placement Agent Warrant (as defined below) are the same as those of
the July 2019 Warrants.
National Securities Corporation (the “Placement Agent”)
acted as placement agent in the offering pursuant to a Placement
Agent Agreement, dated July 9, 2019 (the “Placement Agent
Agreement”). Pursuant to the Placement Agent Agreement, the
Company paid to the Placement Agent a commission of 10% of the
gross proceeds from the offering, reimbursed $30,000 of the
Placement Agent’s expenses and issued to the Placement Agent
a warrant exercisable for 173,685 shares of common stock (the
“Placement Agent Warrant”).
On December 11, 2019, the Company completed an offering of its
Series A Convertible Preferred Stock (“Series A Preferred
Stock”), described below under Note 8. In connection with the
offering, the Company retired $1,919,008 aggregate principal amount
of the July 2019 Notes and $24,184 in accrued interest, which
amounts were used by the noteholders to purchase an aggregate of
1,690.58 shares of Series A Preferred Stock.
As of June 30, 2020, the Company had converted or repaid all of the
July 2019 Notes.
14
Note 7 – Bank Loans
U.S. SBA Paycheck Protection Program
During
the six months ended June 30, 2020, the Company issued a U.S. Small
Business Administration (“SBA”) Paycheck Protection
Program Note (the “SBA Note”) to First Republic Bank
(the “Lender”) for a loan in the amount of $308,600.00
(the “SBA Loan”) under the Paycheck Protection Program
(“PPP”) promulgated under the Coronavirus Aid, Relief
and Economic Security Act of 2020, as modified by the Paycheck
Protection Program Flexibility Act of 2020. The SBA Loan bears
interest at a rate per annum of 1.00%. The term of the SBA Loan is
two years, ending April 22, 2022 (the “Maturity Date”).
No payments will be due on the SBA Loan until the Company’s
application for forgiveness of the SBA Loan has been processed and
completed (the “Deferment Period”), but interest will
accrue during the Deferment Period. Following the Deferment Period,
if the SBA Loan is not entirely forgiven, the Company must pay
monthly principal and interest payments on the outstanding
principal balance of the SBA Loan amortized over the term of the
SBA Loan (the “SBA Loan Payments”), unless forgiven in
whole or in part in accordance with the PPP regulations. These
repayments will begin following the Deferment Period and until the
Maturity Date.
The
Company may apply to the Lender for the SBA Loan to be forgiven
partially or fully if the funding received is used during the
24-week period following disbursement for payroll costs, covered
rent, and covered utilities, provided that at least 60% of the
forgiven amount has been used for payroll costs. We believe that we qualify for forgiveness of the
SBA Loan under the PPP guidelines, but should we be audited or
reviewed as a result of applying for forgiveness or otherwise, such
audit or review could result in the diversion of management’s
time and attention, and legal and reputational costs. If we were to
be audited and receive an adverse finding in such audit, we could
be required to repay the full amount of the SBA Loan, which could
reduce our liquidity, and potentially subject us to additional
fines and penalties.
The
Company may prepay the principal of the SBA Loan at any time
without incurring any prepayment charges. The Company may prepay
20% or less of the unpaid principal balance at any time without
notice. If the Company prepays more than 20% and the SBA Loan has
been sold on the secondary market, the Company must provide the
Lender with written notice, pay all accrued interest and comply
with the other requirements described in the SBA Note for such
repayment.
The
Company did not provide any collateral or personal guarantees for
the SBA Loan, nor did the Company pay any facility charge to the
government or to the Lender.
The SBA
Note also provides for customary events of default, including,
among others, events of default relating to failure to make payment
or comply with the covenants contained in the SBA Note and related
loan documents, defaults on any other loan with the Lender,
defaults on any loan or agreement with another creditor (if the
Lender believes the default may materially affect the
Company’s ability pay the SBA Note), failure to pay any taxes
when due, bankruptcy, breaches of representations, judgment,
reorganization, merger, consolidation or other changes in ownership
or business structure without the Lender’s prior written
consent, and material adverse changes in financial condition or
business operation. Upon an event of default the Lender may require
immediate payment of all amounts owing under the SBA Note, collect
all amounts owing from the Company, or file suit and obtain
judgment.
Toronto-Dominion Bank Loan
On
April 27, 2020, we entered into a commitment loan with TD Bank
under the Canadian Emergency Business Account (“CEBA”), in the
principal aggregate amount of CAD40,000, which is due and payable
on December 31, 2022. This note bears interest on the unpaid
balance at the rate of zero percent (0%) per annum during the
initial term. Under this note no interest or principal payments are
due until January 1, 2023. Under the conditions of the loan,
twenty-five percent (25%) of the loan will be forgiven if
seventy-five percent (75%) is repaid prior to the initial term
date.
Note 8 – Capital Stock
On June 17, 2020, the Company filed a Certificate of Amendment to
its Fourth Amended and Restated Certificate of Incorporation with
the Secretary of State of the State of Delaware effecting an
amendment to increase the number of authorized shares of the
Company’s common stock from 50,000,000 shares to 80,000,000
shares. The Certificate of Amendment was approved by the
Company’s stockholders at the Company’s annual meeting
of stockholders on June 16, 2020.
At June
30, 2020, the authorized capital of the Company consisted of
90,000,000 shares of capital stock, consisting of 80,000,000 shares
of common stock with a par value of $0.0001 per share and
10,000,000 shares of preferred stock with a par value of $0.0001
per share. The Company has designated 10,000 shares of its
preferred stock as Series A Preferred Stock and 1,000 shares of its
preferred stock as Series B Preferred Stock, and the remainder of
9,989,000 shares remain authorized but undesignated.
As of
June 30, 2020, there were 16,437,491 shares of common stock,
896.225 shares of Series A Preferred Stock, and no shares of Series
B Preferred Stock issued and outstanding, and a stock payable
balance of $181,437.
During the six months ended June 30, 2020, the Company issued
6,361,803 shares of its common stock upon the conversion of
5,442.265 shares of its Series A Preferred Stock, and
360,279 shares of its common stock
upon the conversion of 351.711 shares of its Series B
Preferred Stock.
During the six months ended June 30, 2020, the Company issued
331,441 shares of its common stock upon the conversion of $493,847
principal amount of, and in respect of accrued interest on, July
2019 Notes.
During the six months ended June 30, 2020, the Company issued
57,975 shares of its common stock upon warrant exercises
valued at $50,438.
During
the six months ended June 30, 2020, the Company issued or agreed to
issue a total 52,099 shares of its common stock to consultants
pursuant to services agreements with these
consultants.
15
December 2019 Offering of Series A
Preferred Stock, Common
Stock and Warrants
On
December 11, 2019, the Company completed a private placement
offering in which it sold 6,338.490 shares of its Series A
Preferred Stock and 904,526 shares of its common stock, along with
warrants (the “December 11, 2019 Warrants”) exercisable
for an aggregate of 8,190,225 shares of common stock, for
approximately $7.9 million of gross proceeds. The offering was made
pursuant to a Securities Purchase Agreement (the “Purchase
Agreement”), dated as of December 5, 2019, between the
Company and the investors. Pursuant to the Purchase Agreement, each
investor elected whether to receive shares of Series A Preferred
Stock or shares of common stock in the offering. The Company used
approximately $1.9 million of the net proceeds from the offering to
repay debt represented by July 2019 Notes and plans to use the
remaining net proceeds for working capital and general corporate
purposes.
The
simple average of the Daily VWAP (as defined in the Series A
Certificate of Designations) for the 10 consecutive trading days
from January 8, 2020 to January 22, 2020, inclusive, was $1.82,
satisfying the first Forced Conversion Condition. On January 27,
2020, the SEC declared effective the Company’s Registration
Statement on Form S-3 (File No. 333-235883) registering under the
Securities Act the resale of the shares of common stock issuable
upon the conversion of Series A Preferred Stock, shares of common
stock issued in the offering, and shares of common stock issuable
upon the exercise of December 11, 2019 Warrants and December 11,
2019 Warrants.
Each
December 11, 2019 Warrant entitles the holder to purchase a share
of common stock for an exercise price equal to $0.87. The December
11, 2019 Warrants are exercisable commencing immediately upon
issuance and expire on the date five years after the date of
issuance, unless earlier terminated pursuant to the terms of the
December 11, 2019 Warrant. If, during the term of the December 11,
2019 Warrants, the Series A Forced Conversion Conditions are met,
the Company may deliver notice thereof to the holders of the
December 11, 2019 Warrants and, after a 30-day period following
such notice, any unexercised December 11, 2019 Warrants will be
forfeited. The December 11, 2019 Warrants provide for cashless
exercise only if there is no effective registration statement
registering under the Securities Act the resale of the shares of
Common Stock issuable upon exercise of the December 11, 2019
Warrants. As described in the preceding paragraph, the Series A
Forced Conversion Conditions have been met with respect to the
December 11, 2019 Warrants.
The
Securities Purchase Agreement, dated December 5, 2019, includes
customary representations, warranties and covenants. In connection
with the offering, the Company paid to the placement agent a
commission of 8.0% of the gross proceeds from the offering, will
reimburse up to $35,000 of the placement agent’s documented
expenses and issued to the placement agent and its designees
warrants exercisable for an aggregate of 327,606 shares of Common
Stock (the “Series A Placement Agent Warrant”). The
terms of the Series A Placement Agent Warrant are the same as those
of the December 11, 2019 Warrants.
Series A Preferred Stock Deemed Dividend, Beneficial Conversion
Calculation
After
factoring in the relative fair value of the warrants issued in
conjunction with the Series A Preferred Stock, the effective
conversion price is $0.45 per share, compared to the market price
of $0.90 per share on the date of issuance. As a result, a
$4,208,612 beneficial conversion feature was recorded as
a deemed dividend in the consolidated statement of
operations because the Series A Preferred Stock is immediately
convertible, with a credit to additional paid-in capital. The
relative fair value of the warrants issued with the Series A
Preferred Stock of $2,766,941 was recorded as a reduction to the
carrying amount of the preferred stock in the consolidated balance
sheet. The value of the warrants was determined utilizing the
binomial option pricing model using a term of 5 years, a volatility
of 114%, a risk-free interest rate of 1.64%, a 6% rate of
dividends, and a call multiple of 2.
December 2019 Offering of Series B Preferred Stock and
Warrants
On
December 19, 2019, the Company completed a private placement
offering in which the Company sold 351.711 shares of its Series B
Preferred Stock and warrants (the “December 19, 2019
Warrants”) exercisable for an aggregate of 426,316 shares of
the Company’s common stock to the investors for approximately
$405,000 of gross proceeds. The Company plans to use the net
proceeds from the offering for working capital and general
corporate purposes.
The
average daily VWAP requirement of the Series B Forced Conversion
Conditions relating to daily volume-weighted average price of our
Common Stock has not yet been satisfied. On January 27, 2020, the
SEC declared effective the Company’s Registration Statement
on Form S-3 (File No. 333-235883) registering under the Securities
Act the resale of the shares of common stock issuable upon the
conversion of Series B Preferred Stock and upon the exercise of
December 19, 2019 Warrants.
Each
December 19, 2019 Warrant entitles the holder to purchase a share
of common stock for an exercise price equal to $0.99. The December
19, 2019 Warrants are exercisable commencing immediately upon
issuance and expire on the date five years after the date of
issuance, unless earlier terminated pursuant to the terms of the
December 19, 2019 Warrant. If, during the term of the December 19,
2019 Warrants, the Series B Forced Conversion Conditions are met,
the Company may deliver notice thereof to the holders of the
December 19, 2019 Warrants and, after a 30-day period following
such notice, any unexercised December 19, 2019 Warrants will be
forfeited. The December 19, 2019 Warrants provide for cashless
exercise in the event there is no effective registration statement
registering under the Securities Act the resale of the shares of
common stock issuable upon exercise of such December 19, 2019
Warrants.
The
Securities Purchase Agreement, dated December 19, 2019, includes
customary representations, warranties and covenants. In connection
with the closing of the offering, the Company paid to the placement
agent in the offering a commission of approximately 8.0% of the
gross proceeds from the offering and issued to the placement agent
and its designees warrants exercisable for an aggregate of 14,211
shares of common stock (the “Series B Placement Agent
Warrant”). The terms of the Series B Placement Agent Warrant
are the same as those of the Warrants.
16
Series B Preferred Stock Deemed Dividend, Beneficial Conversion
Calculation
After
factoring in the relative fair value of the warrants issued in
conjunction with the Series B Preferred Stock, the effective
conversion price is $0.03 per share, compared to the market price
of $1.36 per share on the date of issuance. As a result, a $11,165
beneficial conversion feature was recorded as a deemed dividend in
the consolidated statement of operations because the Series B
Preferred Stock is immediately convertible, with a credit to
additional paid-in capital. The relative fair value of the warrants
issued with the Series B Preferred Stock of $364,355 was recorded
as a reduction to the carrying amount of the preferred stock in the
consolidated balance sheet. The value of the warrants was
determined utilizing the binomial option pricing model using a term
of 5 years, a volatility of 118%, a risk-free interest rate of
1.75%, a 0% rate of dividends, and a call multiple of
2.
Note 9 – Common Stock Options and Restricted Stock Units
(RSU’s)
Common Stock Options
Stock
options are awarded to the Company’s employees, consultants
and non-employee members of the board of directors under the 2016
Omnibus Incentive Plan (the “Omnibus Plan”) and are
generally granted with an
exercise price equal to the market price of the Company’s
common stock at the date of grant. The aggregate fair value of
these stock options granted by the Company during the six months
ended June 30, 2020 was determined to be $185,602 using the
Black-Scholes-Merton option-pricing model based on the following
assumptions: (i) volatility rate of 116% to 119%, (ii) discount
rate of 0%, (iii) zero expected dividend yield, and (iv) expected
life of 10 years. A summary of option activity under the
Company’s Omnibus Plan as of June 30, 2020, and changes
during the year then ended, is presented below:
|
Number of
Options
|
Weighted Average
Exercise Price
|
Weighted
AverageRemaining Contractual Term (Years)
|
Balance outstanding
at December 31, 2019
|
3,449,319
|
$2.32
|
8.26
|
Granted
|
130,418
|
0.24
|
9.60
|
Exercised
|
-
|
-
|
-
|
Forfeited
|
-
|
-
|
-
|
Cancelled or
expired
|
(3,962)
|
-
|
-
|
Balance outstanding
at June 30, 2020
|
3,575,775
|
$2.28
|
7.84
|
Exercisable at June
30, 2020
|
852,210
|
$4.75
|
4.98
|
Restricted Stock Units
A restricted stock unit grants a participant the right to receive
one share of common stock, following the completion of the
requisite service period. Restricted stock units are classified as
equity. Compensation cost is based on the Company’s stock
price on the grant date and is recognized on a straight-line basis
over the vesting period for the entire award.
As a cash-conserving measure taken in light of the adverse economic
conditions caused by the COVID-19 pandemic, the Company reduced the
cash salaries of members of management by 33% for the remainder of
2020, including the salaries of its named executive officers. In
lieu of cash, the Company is paying this portion of management
salaries in the form of restricted stock units (the
“RSU’s”) that vest over the remainder of the
year. Additionally, the Company amended its Non-Employee Director
Compensation Policy to provide that its non-employee
directors’ annual retainers for the second, third and fourth
fiscal quarters of 2020 will also be paid in in the form of
RSU’s rather than cash.
On April 9, 2020, the Company granted 674,019 RSU’s to
non-employee directors and certain members of management. The
461,146 RSU’s granted to management vest daily over the term
through December 31, 2020. The 212,873 RSU’s granted to
directors’ vest in three equal quarterly installments on the
last date of the second, third and fourth fiscal quarters of 2020.
The total fair value of the RSU’s granted on April 9, 2020
was $471,813, based on the grant date closing price of $0.70 per
share.
17
As of June 30, 2020 the Company had issued and vested the following
RSU’s:
|
Restricted Stock
Units Outstanding
|
Weighted Average
Grant Date Fair Value
|
Balance
Outstanding at December 31, 2019
|
-
|
$-
|
Granted
|
674,019
|
0.70
|
Vested
/ Released
|
(217,293)
|
-
|
Forfeited
|
-
|
-
|
Cancelled
or expired
|
-
|
-
|
Balance
outstanding at June 30, 2020
|
456,726
|
$0.70
|
Note 10 – Common Stock Warrants
During the six months ended June 30, 2020, the Company issued an
aggregate of 57,975 shares of its common stock upon warrant
exercises valued at $50,438.
The following table summarizes all stock warrant activity of the
Company for the six months ended June 30, 2020:
|
Number of
Warrants
|
Weighted
AverageExercise Price
|
Weighted
AverageContractual Term (Years)
|
Balance outstanding
at December 31, 2019
|
13,496,924
|
$2.02
|
4.07
|
Granted
|
-
|
-
|
-
|
Exercised
|
(57,975)
|
0.87
|
4.45
|
Forfeited
|
-
|
-
|
-
|
Expired
|
(115,250)
|
-
|
-
|
Balance outstanding
at June 30, 2020
|
13,323,699
|
$1.88
|
3.60
|
Exercisable at June
30, 2020
|
13,323,699
|
$1.88
|
3.60
|
18
Note 11 – Commitments & Contingencies
Office Lease
Effective January 1, 2015, the Company entered into an office lease
agreement with Green Court, LLC, a Michigan limited liability
company, for approximately 3,657 rentable square feet of space, for
the initial monthly rent of $5,986, which commenced on January 1,
2015 for an initial term of 60 months. On October 10, 2017 this
lease was amended increasing the rentable square feet of space to
3,950 and the monthly rent to $7,798. On July 16, 2019, the Company
exercised its option to extend the lease for an additional 5 years
past the initial term originally expiring on December 31, 2019,
such that the lease now expires on December 31, 2024.
The
Company records the lease asset and lease liability at the present
value of lease payments over the lease term. The lease typically
does not provide an implicit rate; therefore, the Company uses its
estimated incremental borrowing rate at the time of lease
commencement to discount the present value of lease payments. The
Company’s discount rate for operating leases at June 30, 2020
was 10%. Lease expense is recognized on a straight-line basis over
the lease term to the extent that collection is considered
probable. As a result, the Company has been recognizing rents as
they become payable based on the adoption of ASC Topic 842. The
weighted-average remaining lease term is 4.67 years.
As of
June 30, 2020, the maturities of operating lease liabilities are as
follows:
|
Operating
Lease
|
2020
|
$49,395
|
2021
|
101,752
|
2022
|
104,793
|
2023
|
107,954
|
2024 and
beyond
|
111,192
|
Total
|
$475,086
|
Less: amount
representing interest
|
(95,635)
|
Present value of
future minimum lease payments
|
379,451
|
Less: current
obligations under leases
|
71,085
|
Long-term lease
obligations
|
$308,366
|
For the three months ended June 30, 2020 and 2019, the Company
incurred rent expenses of $30,615 and $29,319,
respectively.
For the six months ended June 30, 2020 and 2019, the Company
incurred rent expenses of $60,903 and $52,507,
respectively.
Employment and Consulting Agreements
Francois Michelon –
Effective May 12, 2017, the Company entered into an amended and
restated employment agreement with Francois Michelon, the
Company’s Chief Executive Officer and Chairman of the board
of directors. The term of the employment agreement runs through
December 31, 2019 and continues on a year-to-year basis thereafter.
The employment agreement provides for an annual base salary that is
subject to adjustment at the board of directors’ discretion.
The annual base salary in effect during the period covered by this
Form 10-Q was $355,350. Under the employment agreement, Mr.
Michelon is eligible for an annual cash bonus based upon
achievement of performance-based objectives established by the
board of directors. Pursuant to Mr. Michelon’s employment
agreement, in connection with the closing of the Company’s
initial public offering he was granted options to purchase an
aggregate 339,270 shares of common stock. The options have a
weighted average exercise price of $4.96 per share of common stock
and vest in three equal annual installments beginning on May 12,
2018. Upon termination without cause, any portion of Mr.
Michelon’s option award scheduled to vest within 12 months
will automatically vest, and upon termination without cause within
12 months following a change of control, the entire unvested
portion of the option award will automatically vest. Upon
termination for any other reason, the entire unvested portion of
the option award will terminate.
If Mr. Michelon’s employment is terminated by the Company
without cause, Mr. Michelon will be entitled to receive 12
months’ continuation of his current base salary and a lump
sum payment equal to 12 months of continued healthcare coverage (or
24 months’ continuation of his current base salary and a lump
sum payment equal to 24 months of continued healthcare coverage if
such termination occurs within one year following a change in
control).
Under his employment agreement, Mr. Michelon is eligible to receive
benefits that are substantially similar to those of the
Company’s other senior executive officers.
On December 27, 2019, the Company entered into an amendment to Mr.
Michelon’s employment agreement to provide that (i) Mr.
Michelon’s employment with the Company will continue until
terminated under the terms the employment agreements, and (ii) Mr.
Michelon will each receive certain payments if he is terminated by
the Company without Cause (as defined in the employment agreement
amendment) or he resigns for Good Reason (as defined in the
employment agreement amendment).
On April 9, 2020, the Company granted Mr. Michelon 123,064
restricted stock units in lieu of $86,145 of his cash salary.
Subject to continued employment, the restricted stock units vest
each day, pro rata based on the number of days between the grant
date and December 31, 2020.
19
Michael Thornton –
Effective May 12, 2017, the Company entered into an amended and
restated employment agreement with Michael Thornton, the
Company’s Chief Technology Officer. The term of the
employment agreement runs through December 31, 2019 and continues
on a year-to-year basis thereafter. The employment agreement
provides for an annual base salary that is subject to adjustment at
the board of directors’ discretion. The annual base salary in
effect during the period covered by this Form 10-Q was $267,800.
Under the employment agreement, Mr. Thornton is eligible for an
annual cash bonus based upon achievement of performance-based
objectives established by the board of directors. Pursuant to Mr.
Thornton’s employment agreement, in connection with the
closing of the Company’s initial public offering he was
granted options to purchase an aggregate 345,298 shares of common
stock. The options have a weighted average exercise price of $4.96
per share of common stock and vest in three equal annual
installments beginning on May 12, 2018. Upon termination without
cause, any portion of Mr. Thornton’s option award scheduled
to vest within 12 months will automatically vest, and upon
termination without cause within 12 months following a change of
control, the entire unvested portion of the option award will
automatically vest. Upon termination for any other reason, the
entire unvested portion of the option award will
terminate.
If Mr. Thornton’s employment is terminated by the Company
without cause, Mr. Thornton will be entitled to receive 12
months’ continuation of his current base salary and a lump
sum payment equal to 12 months of continued healthcare coverage (or
24 months’ continuation of his current base salary and a lump
sum payment equal to 24 months of continued healthcare coverage if
such termination occurs within one year following a change in
control).
Under his employment agreement, Mr. Thornton is eligible to receive
benefits that are substantially similar to those of the
Company’s other senior executive officers.
On December 27, 2019, the Company entered into an amendment to Mr.
Thornton’s employment agreement to provide that (i) Mr.
Thornton’s employment with the Company will continue until
terminated under the terms the employment agreements, and (ii) Mr.
Thornton will each receive certain payments if he is terminated by
the Company without Cause (as defined in the employment agreement
amendment) or he resigns for Good Reason (as defined in the
employment agreement amendment).
On April 9, 2020, the Company granted Mr. Thornton 96,213
restricted stock units in lieu of $67,349 of his cash salary.
Subject to continued employment, the restricted stock units vest
each day, pro rata based on the number of days between the grant
date and December 31, 2020.
David Wells – On May
12, 2017, the Company entered into a consulting agreement with
StoryCorp Consulting (“StoryCorp”), pursuant to which
David Wells provided services to the Company as its Chief Financial
Officer. Pursuant to the consulting agreement, the Company paid to
StoryCorp a monthly fee of $9,000, and in May 2018 this monthly fee
was increased to $9,540. Additionally, pursuant to the consulting
agreement, the Company granted to Mr. Wells a stock option to
purchase 15,000 shares of common stock in connection with the
closing of the Company’s initial public offering, having an
exercise price per share equal to $5.00 and vesting in twelve equal
quarterly installments, and, for so long as the consulting
agreement was in place, granted to Mr. Wells a stock option to
purchase the same number of shares of common stock with the same
terms on each annual anniversary of the date of the consulting
agreement. In May 2018, the annual stock option amount was
increased and on December 13, 2018, Mr. Wells was granted options
to purchase an additional 35,000 shares of common
stock.
On May
13, 2019, the Company entered into an employment agreement with
David Wells that supersedes the consulting agreement between the
Company and StoryCorp. The employment agreement provides for an
annual base salary of $230,000 and eligibility for an annual cash
bonus to be paid based on attainment of Company and individual
performance objectives to be established by the Company’s
board of directors (in 2019, the amount of such cash bonus if all
goals were achieved would be 30% of the base salary plus base fees
paid to StoryCorp under the consulting agreement). The employment
agreement also provides for eligibility to receive benefits
substantially similar to those of the Company’s other senior
executive officers.
Pursuant
to the employment agreement, on May 13, 2019 Mr. Wells was granted
stock options to purchase 56,000 shares of the Company’s
common stock. The stock options have an exercise price of $1.38 per
share, and vest in three equal annual installments beginning on the
first anniversary of the grant date.
On April 9, 2020, the Company granted Mr. Wells 79,653 restricted
stock units in lieu of $55,757 of his cash salary. Subject to
continued employment, the restricted stock units vest each day, pro
rata based on the number of days between the grant date and
December 31, 2020.
Litigation
From time to time the Company may become a party to litigation in
the normal course of business. There are currently no legal matters
that management believes would have a material effect on the
Company’s financial position or results of
operations.
Note 12 – Subsequent Events
Warrant Conversions and Consent Solicitation
On August 3, 2020, the Company filed with the Securities Exchange
Commission (the "SEC") a Consent Solicitation Statement relating to
the potential issuance of the Company’s common stock upon the
exercise of outstanding warrants, each holder of which having
proposed that the Company partially waive the exercise price of
such holder’s warrant (collectively, the “Reduced
Exercise Price Warrants”). The Consent Solicitation Statement
disclosed that, as of July 22, 2020, the Company had partially
waived the exercise prices of Reduced Exercise Price Warrants
exercisable for an aggregate of approximately 3.1 million shares of
common stock for aggregate gross proceeds of approximately $2.2
million. In the event that the Company’s stockholders approve
the Company’s proposal described in the Consent Solicitation
Statement, the Company may issue up to an additional 8.1 million
shares of common stock upon the exercise of Reduced Exercise Price
Warrants.
Common Stock Issued
Subsequent
to the period ended June 30, 2020, the Company issued a total
of 811,423 shares of common stock upon the conversion
of an aggregate of 699.498 shares of Series A Convertible
Preferred Stock at the request
of its holder.
Subsequent
to the period ended June 30, 2020, the Company issued a total of
539,365 shares of common stock in return for gross proceeds of
$550,307 from the at-the-market facility.
20
Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
Forward-Looking Statements
As used
in this Quarterly Report on Form 10-Q (this “Form
10-Q”), unless the context otherwise requires, the terms
“we,” “us,” “our,”
“ENDRA” and the “Company” refer to ENDRA
Life Sciences Inc., a Delaware corporation, and its wholly-owned
subsidiary. The following discussion and analysis of our financial
condition and results of operations should be read in conjunction
with our historical financial statements and related notes thereto
in this Form 10-Q. This Form 10-Q contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended, that are intended to be covered by the
“safe harbor” created by those sections.
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,”
“estimate,” “anticipate” or other
comparable terms. All statements other than statements of
historical facts included in this Form 10-Q regarding our
strategies, prospects, financial condition, operations, costs,
plans and objectives are forward-looking statements. Examples of
forward-looking statements include, among others, statements we
make regarding expectations for revenues, cash flows and financial
performance, the anticipated results of our development efforts and
the timing for receipt of required regulatory approvals and product
launches. Forward-looking statements are neither historical facts
nor assurances of future performance. Instead, they are based only
on our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, projections,
anticipated events and trends, the economy and other future
conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of our control. Our actual results and financial
condition may differ materially from those indicated in the
forward-looking statements. Therefore, you should not rely on any
of these forward-looking statements. Important factors that could
cause our actual results and financial condition to differ
materially from those indicated in the forward-looking statements
include, among others, the following: our limited commercial
experience, limited cash and history of losses; our ability to
obtain adequate financing to fund our business operations in the
future; our ability to achieve profitability; our ability to
develop a commercially feasible application based on our
Thermo-Acoustic Enhanced Ultrasound (“TAEUS”)
technology; market acceptance of our technology; uncertainties
associated with COVID-19 or coronavirus, including its possible
effects on our operations; results of our human studies, which may
be negative or inconclusive; our ability to find and maintain
development partners; our reliance on collaborations and strategic
alliances and licensing arrangements; the amount and nature of
competition in our industry; our ability to protect our
intellectual property; potential changes in the healthcare industry
or third-party reimbursement practices; delays and changes in
regulatory requirements, policy and guidelines including potential
delays in submitting required regulatory applications for CE mark
certification or Food and Drug Administration (“FDA”)
approval; our ability to obtain CE mark certification and secure
required FDA and other governmental approvals for our TAEUS
applications; our ability to comply with regulation by various
federal, state, local and foreign governmental agencies and to
maintain necessary regulatory clearances or approvals; and the
other risks and uncertainties described in the Risk Factors section
of our Annual Report on Form 10-K for the period ended December 31,
2019, as filed with the SEC on March 26, 2020, and in the
Management’s Discussion and Analysis of Financial Condition
and Results of Operations section of this Form 10-Q. We undertake
no obligation to publicly update any forward-looking statement,
whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or
otherwise.
Available Information
From time to time, we use press releases, Twitter (@endralifesci)
and LinkedIn (www.linkedin.com/company/endra-inc) to distribute
material information. Our press releases and financial and other
material information are routinely posted to and accessible on the
Investors section of our website, www.endrainc.com. Accordingly,
investors should monitor these channels, in addition to our SEC
filings and public conference calls and webcasts. In addition,
investors may automatically receive e-mail alerts and other
information about the Company by enrolling their e-mail addresses
by visiting the “Email Alerts” section of our website
at investors.endrainc.com. Information that is contained in and can
be accessed through our website, Twitter posts and LinkedIn are not
incorporated into, and do not form a part of, this Quarterly Report
or any other report or document we file with the SEC.
Overview
We are leveraging experience with pre-clinical enhanced ultrasound
devices to develop technology for increasing the capabilities of
clinical diagnostic ultrasound, to broaden patient access to the
safe diagnosis and treatment of a number of significant medical
conditions in circumstances where expensive X-ray computed
tomography (“CT”) and magnetic resonance imaging
(“MRI”) technology, or other diagnostic technologies
such as surgical biopsy, are unavailable or
impractical.
In 2010, we began marketing and selling our Nexus 128 system, which
combined light-based thermoacoustics and ultrasound to address the
imaging needs of researchers studying disease models in
pre-clinical applications. Building on this expertise in
thermoacoustics, we have developed a next-generation technology
platform — Thermo Acoustic Enhanced Ultrasound, or TAEUS
— which is intended to enhance the capability of clinical
ultrasound technology and support the diagnosis and treatment of a
number of significant medical conditions that currently require the
use of expensive CT or MRI imaging or where imaging is not
practical using existing technology. We ceased production, service
support and parts for our Nexus 128 system in 2019 in order to
focus our resources on the development of our TAEUS
technology.
Unlike the near-infrared light pulses used in our legacy Nexus 128
system, our TAEUS technology uses radio frequency
(“RF”) pulses to stimulate tissues, using a small
fraction (less than 1%) of the energy that would be transmitted
into the body during an MRI scan. The use of RF energy allows our
TAEUS technology to penetrate deep into tissue, enabling the
imaging of human anatomy at depths equivalent to those of
conventional ultrasound. The RF pulses are absorbed by tissue and
converted into ultrasound signals, which are detected by an
external ultrasound receiver and a digital acquisition system that
is part of the TAEUS system. The detected ultrasound is processed
into images and other forms of data using our proprietary
algorithms and displayed to complement conventional gray-scale
ultrasound images.
21
We expect that the first-generation TAEUS application will be a
standalone ultrasound accessory designed to cost-effectively
quantify fat in the liver and stage progression of nonalcoholic
fatty liver disease (“NAFLD”), which can only be
achieved today with impractical surgical biopsies or MRI scans.
Subsequent TAEUS offerings are expected to be implemented via a
second generation hardware platform that can run multiple clinical
software applications that we will offer TAEUS users for a one-time
licensing fee – adding ongoing customer value to the TAEUS
platform and a growing software revenue stream for our
Company.
In April 2016, we entered into a Collaborative Research Agreement
with General Electric Company, acting through its GE Healthcare
business unit and the GE Global Research Center (collectively,
“GE Healthcare”). Under the terms of the agreement, GE
Healthcare has agreed to assist us in our efforts to commercialize
our TAEUS technology for use in a fatty liver application by, among
other things, providing equipment and technical advice, and
facilitating introductions to GE Healthcare clinical ultrasound
customers. In return for this assistance, we have agreed to afford
GE Healthcare certain rights of first offer with respect to
manufacturing and licensing rights for the target application. On
January 13, 2020, we and GE Healthcare entered into an amendment to
our agreement, extending its term by 12 months to January 14, 2021
and modifying GE Healthcare’s rights of first
offer.
In November 2017, we engaged two firms that specialize in medical
device software development to commence productization of our TAEUS
device targeting NAFLD. The agreements call for these vendors to
provide us with the specialized engineering resources necessary to
translate our current prototype TAEUS device into a clinical
product that meets CE regulatory requirements required for
commercial launch in the European Union followed by U.S. Food and
Drug Administration (“FDA”) submission for the U.S.
market.
Each of our TAEUS platform applications will require regulatory
approvals before we are able to sell or license the application.
Based on certain factors, such as the installed base of ultrasound
systems, availability of other imaging technologies, such as CT and
MRI, economic strength and applicable regulatory requirements, we
intend to seek initial approval of our applications for sale in the
European Union and the United States, followed by
China.
In
March 2020, we received Conformité Européene
(“CE”) mark approval for our TAEUS FLIP (Fatty Liver
Imaging Probe) System. The CE marking indicates that TAEUS FLIP
System complies with all applicable European Directives and
Regulations in the European Union and other CE mark geographies,
including the 27 EU member states.
In June
2020, we submitted a 510(k) Application to the FDA for our TAEUS
FLIP System.
Financial Operations Overview
Revenue
No revenue has been generated by our TAEUS technology, which we
have not yet commercially sold.
Cost of Goods Sold
No cost of goods sold has been generated by our TAEUS technology,
which we have not yet commercially sold.
Research and Development Expenses
Our research and development expenses primarily include wages, fees
and equipment for the development of our TAEUS technology platform
and the proposed applications. Additionally, we incur certain costs
associated with the protection of our products and inventions
through a combination of patents, licenses, applications and
disclosures.
Sales and Marketing Expenses
Sales and marketing expenses consist primarily of headcount and
consulting costs, and marketing and tradeshow expenses. Currently,
our marketing efforts are through our website and attendance of key
industry meetings and conferences. In connection with the
commercialization of our TAEUS applications, we expect to
build a small sales and marketing team to train and support global
ultrasound distributors, as well as execute traditional marketing
activities such as promotional materials, electronic media and
participation in industry events and conferences.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries
and related expenses for our management and personnel, and
professional fees, such as accounting, consulting and
legal.
22
Critical Accounting Policies and Estimates
Use of Estimates
The preparation of the financial statements in conformity with
accounting principles generally accepted in the United States
requires management to make estimates and assumptions that affect
the reported amounts of assets and liabilities, and disclosure of
contingent liabilities at the date of the financial statements and
the reported amounts of expenses during the reporting period.
Actual results could differ from those estimates.
Management makes estimates that affect certain accounts including
deferred income tax assets, accrued expenses, fair value of equity
instruments and reserves for any other commitments or
contingencies. Any adjustments applied to estimates are recognized
in the period in which such adjustments are
determined.
Share-based Compensation
Our 2016 Omnibus Incentive Plan (the “Omnibus Plan”)
permits the grant of stock options and other stock awards to our
employees, consultants and non-employee members of our board of
directors. Each January 1 the pool of shares available for issuance
under the Omnibus Plan automatically increases by an amount equal
to the lesser of (i) the number of shares necessary such that the
aggregate number of shares available under the Omnibus Plan equals
25% of the number of fully-diluted outstanding shares on the
increase date (assuming the conversion of all outstanding shares of
preferred stock and other outstanding convertible securities and
exercise of all outstanding options and warrants to purchase
shares) and (ii) if the board of directors takes action to set a
lower amount, the amount determined by the board. On January 1,
2020, the pool of shares issuable under the Omnibus Plan
automatically increased by 3,202,280 shares from 2,649,378 shares
to 5,861,658. As of June 30, 2020, there were 2,285,883 shares of
common stock remaining available for issuance under the Omnibus
Plan.
We record share-based compensation in accordance with the
provisions of the Share-based Compensation Topic of the FASB
Codification. The guidance requires the use of option-pricing
models that require the input of highly subjective assumptions,
including the option’s expected life and the price volatility
of the underlying stock. The fair value of each option grant is
estimated on the date of grant using the Black-Scholes option
valuation model which uses certain assumptions related to risk-free
interest rates, expected volatility, expected life of the common
stock options, and future dividends, and the resulting charge is
expensed using the straight-line attribution method over the
vesting period.
Stock compensation expense recognized during the period is based on
the value of share-based awards that were expected to vest during
the period adjusted for estimated forfeitures. The estimated fair
value of grants of stock options and warrants to non-employees is
charged to expense, if applicable, in the financial
statements.
Debt Discount and Detachable Debt-Related Warrants
The
Company accounts for debt discounts originating in connection with
conversion features that are embedded in the notes related warrants
in accordance with ASC Subtopic 470-20, Debt with Conversion and Other Options.
These costs are classified on the consolidated balance sheet as a
direct deduction from the debt liability. The Company amortizes
these costs over the term of the securities as interest
expense-debt discount in the consolidated statement of operations.
Debt discounts relate to the relative fair value of warrants issued
in conjunction with the debt and are also recorded as a reduction
to the debt balance and accreted over the expected term of the
securities to interest expense.
Recent Accounting Pronouncements
See Note 2 of the accompanying financial statements for a
discussion of recently issued accounting standards.
Results of Operations
Three months ended June 30, 2020 and 2019
Revenue
We had
no revenue during the three months ended June 30, 2020 and
2019.
Cost of Goods Sold
We had
no cost of goods sold during the three months ended June 30, 2020
and 2019.
23
Research and Development
Research
and development expenses were $1,487,049 for the three months ended
June 30, 2020, as compared to $1,304,808 for the three months ended
June 30, 2019, an increase of $182,241, or 14%. The costs include
primarily wages, fees and equipment for the development of our
TAEUS product line. Research and development expenses increased
from the same period for the prior year based on increased spending
for regulatory activities and product development.
Sales and Marketing
Sales
and marketing expenses were $134,763 for the three months ended
June 30, 2020, as compared to $88,343 for the three months ended
June 30, 2019, an increase of $46,420, or 53%. The increase was
primarily due to additional headcount and pre-selling activities
for our TAEUS product line. Currently, our marketing efforts are
through our website and attendance of key industry meetings.
Subsequent to the period ending June 30, 2020 we began hiring and
training additional staff to support our sales efforts. As we seek
to complete the development and commercialization of our TAEUS
applications, we intend to build a small sales and marketing team
to train and support global ultrasound distributors, as well as
execute traditional marketing activities such as promotional
materials, electronic media and participation in industry
conferences.
General and Administrative
General
and administrative expenses for the three months ended June 30,
2020 were $1,269,467, compared to $932,021 for the three months
ended June 30, 2019, an increase of $337,446, or 36%. Our wage and
related expenses for the three months ended June 30, 2020 were
$556,424, compared to $501,850 for the three months ended June 30,
2019. Wage and related expenses in the three months ended June 30,
2020 included $53,751 for bonuses and $225,833 of stock
compensation expense related to the issuance and vesting of
options, compared to $58,731 for bonuses, $178,905 of stock
compensation expense related to the issuance and vesting of options
for the three months ended June 30, 2019. Our professional fees,
which include legal, audit, and investor relations, for the three
months ended June 30, 2020 were $592,529, compared to $334,486 for
the three months ended June 30, 2019.
Amortization of Debt Discount
During
the three months ended June 30, 2020, we incurred non-cash expenses
of $3,858 related to the amortization of debt discount incurred as
result of our issuance of our convertible notes and warrants issued
in July 2019. There were no such expenses during the three months
ended June 30, 2019.
Net Loss
As a
result of the foregoing, for the three months ended June 30, 2020,
we recorded a net loss of $2,893,872, compared to a net loss of
$2,334,371 for the three months ended June 30, 2019.
Six months ended June 30, 2020 and 2019
Revenue
We had
no revenue during the six months ended June 30, 2020 and
2019.
Cost of Goods Sold
We had
no cost of goods sold during the six months ended June 30, 2020 and
2019.
Research and Development
Research
and development expenses were $3,005,195 for the six months ended
June 30, 2020, as compared to $3,078,306 for the six months ended
June 30, 2019, a decrease of $73,111, or 2%. The costs include
primarily wages, fees and equipment for the development of our
TAEUS product line. Research and development expenses decreased
from the same period for the prior year as we completed development
of the TAEUS product and began focusing our spending on
commercialization of the product that has been
developed.
24
Sales and Marketing
Sales
and marketing expenses were $249,718 for the six months ended June
30, 2020, as compared to $145,161 for the six months ended June 30,
2019, an increase of $104,557, or 72%. The increase was primarily
due to additional headcount and pre-selling activities for our
TAEUS product line. Currently, our marketing efforts are through
our website and attendance of key industry meetings. Subsequent to
the period ending June 30, 2020 we began hiring and training
additional staff to support our sales efforts. As we seek to
complete the development and commercialization of our TAEUS
applications, we intend to build a small sales and marketing team
to train and support global ultrasound distributors, as well as
execute traditional marketing activities such as promotional
materials, electronic media and participation in industry
conferences.
General and Administrative
Our
general and administrative expenses for the six months ended June
30, 2020 were $2,737,212, compared to $1,848,924 for the six months
ended June 30, 2019, an increase of $888,288, or 48%. Our wage and
related expenses for the six months ended June 30, 2020 were
$1,203,867, compared to $910,194 for the six months ended June 30,
2019. Wage and related expenses in the six months ended June 30,
2020 included $119,944 for bonuses and $475,418 of stock
compensation expense related to the issuance and vesting of
options, compared to $93,102 for bonuses, $350,742 of stock
compensation expense related to the issuance and vesting of options
for the six months ended June 30, 2019. Our professional fees,
which include legal, audit, and investor relations, for the six
months ended June 30, 2020 were $1,261,804, compared to $692,305
for the six months ended June 30, 2019.
Amortization of Debt Discount
During
the six months ended June 30, 2020, we incurred non-cash expenses
of $232,426 related to the amortization of debt discount incurred
as result of our issuance of our convertible notes and warrants
issued in July 2019. There were no such expenses during the six
months ended June 30, 2019.
Net Loss
As a
result of the foregoing, for the six months ended June 30, 2020, we
recorded a net loss of $6,216,669, compared to a net loss of
$5,083,107 for the six months ended June 30, 2019.
Liquidity and Capital Resources
To date
we have funded our operations through private and public sales of
our securities. As of June 30, 2020, we had $748,561 in cash. We
have completed the following financing events from January 2019
through June 30, 2020:
● In July 2019, we completed a
private placement of senior secured convertible promissory notes
and warrants, raising net proceeds of approximately $2.5 million
after deducting offering expenses of approximately $314,500 payable
by us. The promissory notes accrued interest at a rate of 10% per
annum until maturity on April 26, 2020.
● In December
2019, we completed
private placements of shares of Series A Preferred Stock, shares of
Series B Preferred Stock, shares of common stock and warrants,
raising net proceeds of approximately $5.8 million after using
approximately $1.9 million to repay debt represented by convertible
promissory notes issued in July 2019 and deducting offering
expenses of approximately $766,000 payable by
us.
● In
March 2020, we entered into an at-the-market equity offering sales
agreement (the “ATM Agreement”) with H.C. Wainwright
& Co., LLC (“Wainwright”) to sell shares of our
common stock for aggregate gross proceeds of up to $7.2 million,
from time to time, through an “at-the-market” equity
offering program under which Wainwright acts as sales agent.
Pursuant to the ATM Agreement, Wainwright may sell the shares in
sales deemed to be “at-the-market” equity offerings as
defined in Rule 415 under the Securities Act, including sales made
directly on or through the Nasdaq Capital Market. If agreed to in a
separate terms agreement, we may sell shares to Wainwright as
principal at a purchase price agreed upon by Wainwright and the
Company. Wainwright may also sell shares in negotiated transactions
with our prior approval. The offer and sale of the shares pursuant
to the ATM Agreement will terminate upon the earlier of (a) the
issuance and sale of all of the shares subject to the ATM Agreement
or (b) the termination of the ATM Agreement by Wainwright or us
pursuant to its terms. As of June 30, 2020, we had issued 882,493
shares of our common stock in return for gross proceeds of $791,474
from the at-the-market facility.
●
During the three
months ended June 30, 2020, we received a total of $337,084 in
proceeds from loans from both the SBA and Toronto-Dominion Bank
related to Coronavirus aid relief. Please see Note 7 for a further
description of these loans,
We
believe that cash on hand at June 30, 2020 will only be sufficient
to fund our current operations into the third quarter of 2020. We
will need additional capital to execute our commercialization plan
and if we do not raise additional capital in the next several
months we will need to significantly slow or pause our business
activities until such time as we are able to raise additional
capital. We continue to evaluate and manage our capital needs to
support our clinical, regulatory and operational activities and
prepare for the results of our human studies data and EU
commercialization. Subsequent to June 30, 2020, we received
approximately $2.2 million from the exercise of warrants for
reduced exercise prices and are seeking stockholder approval under
Nasdaq rules in order to issue additional shares of common stock
upon the exercise of certain warrants at reduced exercise prices.
We are also exploring potential financing options that may be
available to us, including additional sales of our common stock
through the ATM Agreement and by causing the mandatory exercise of
our warrants issued on December 11, 2019 for cash for those
warrants that have not yet been exercised. However, we have no
commitments to obtain any additional funds, and there can be no
assurance funds will be available in sufficient amounts or on
acceptable terms. If we are unable to obtain sufficient additional
financing in a timely fashion and on terms acceptable to us, our
financial condition and results of operations may be materially
adversely affected and we may not be able to continue operations or
execute our stated commercialization plan.
The
financial statements included in this Form 10-Q have been prepared
assuming we will continue as a going concern, which contemplates
the realization of assets and the settlement of liabilities and
commitments in the normal course of business. As reflected in the
accompanying financial statements, during the six months ended June
30, 2020, we incurred net losses of $6,216,669 and used cash in
operations of $6,582,292. These and other factors raise substantial
doubt about our ability to continue as a going concern for one year
from the issuance of the accompanying financial statements. The
financial statements do not include any adjustments that might be
necessary should we be unable to continue as a going
concern.
25
Operating Activities
During
the six months ended June 30, 2020, we used $6,582,292 of cash in
operating activities primarily as a result of our net loss of
$6,216,669, offset by share-based compensation of $1,057,120,
amortization of debt discount of $232,426, depreciation expense of
$44,014, amortization of Right of Use assets of $32,199, and net
changes in operating assets and liabilities of
$(1,689,122).
During the six months ended June 30, 2019, we used $4,198,607 of
cash in operating activities primarily as a result of our net loss
of $5,083,107, which included non-cash charges for share-based
compensation of $659,217, depreciation expenses of $39,744, and net
changes in operating assets and liabilities of
$(185,539).
Investing Activities
During
the six months ended June 30, 2020, the Company used $22,350 in
investing activities related to purchases of
equipment.
During the six months ended June 30, 2019, the Company used $5,238
in investing activities related to purchase of
equipment.
Financing Activities
During
the six months ended June 30, 2020, financing activities provided
$1,178,996, including $50,438 in proceeds from warrant exercises,
$337,084 in proceeds from loans, $791,474 in proceeds from issuance
of common stock, and $42,260 paid
on account of repayment of notes.
During
the six months ended June 30, 2019, there were no cash flows from
financing activities.
Funding Requirements
We have
not completed the commercialization of any of our TAEUS technology
platform applications. We expect to continue to incur significant
expenses for the foreseeable future. We anticipate that our
expenses will increase substantially as we:
● advance the engineering design and development of
our NAFLD TAEUS application;
● acquire parts and build finished goods inventory
of the TAEUS FLIP system;
● prepare regulatory filings required for marketing
approval of our NAFLD TAEUS application in the United
States;
● seek
to hire a small internal marketing team to engage and support
channel partners and clinical customers for our NAFLD TAEUS
application;
● commence marketing of our NAFLD TAEUS
application;
● advance development of our other TAEUS
applications; and
● add
operational, financial and management information systems and
personnel, including personnel to support our product development,
planned commercialization efforts and our operation as a public
company.
26
It is
possible that we will not achieve the progress that we expect
because the actual costs and timing of completing the development
and regulatory approvals for a new medical device are difficult to
predict and are subject to substantial risks and delays. We have no
committed external sources of funds. We do not expect that our
existing cash will be sufficient for us to complete the
commercialization of our NAFLD TAEUS application or to complete the
development of any other TAEUS application and we will need to
raise substantial additional capital for those purposes. As a
result, we will need to finance our future cash needs through
public or private equity offerings, debt financings, corporate
collaboration and licensing arrangements or other financing
alternatives. Our forecast of the period of time through which our
financial resources will be adequate to support our operations is a
forward-looking statement and involves risks and uncertainties, and
actual results could vary as a result of a number of factors,
including the factors discussed in the section of this Quarterly
Report on Form 10-Q entitled “Risk Factors” and such
section of our most recently filed Annual Report on Form 10-K. We
have based this estimate on assumptions that may prove to be wrong,
and we could utilize our available capital resources sooner than we
currently expect.
Until
we can generate a sufficient amount of revenue from our TAEUS
platform applications, if ever, we expect to finance future cash
needs through public or private equity offerings, debt financings
or corporate collaborations and licensing arrangements. Additional
funds may not be available when we need them on terms that are
acceptable to us, or at all. As described below, the COVID-19
pandemic has impacted our business operations to some extent and is
expected to continue to do so and, in light of the effect of such
pandemic on financial markets, these impacts may include reduced
access to capital. If adequate funds are not available, we may be
required to delay, reduce the scope of or eliminate one or more of
our research or development programs or our commercialization
efforts or perhaps even cease the operation of our business. To the
extent that we raise additional funds by issuing equity securities,
our stockholders may experience additional dilution, and debt
financing, if available, may involve restrictive covenants. To the
extent that we raise additional funds through collaborations and
licensing arrangements, it may be necessary to relinquish some
rights to our technologies or applications or grant licenses on
terms that may not be favorable to us. We may seek to access the
public or private capital markets whenever conditions are
favorable, even if we do not have an immediate need for additional
capital at that time.
Coronavirus (“COVID-19”) Pandemic
The
COVID-19 outbreak, which the World Health Organization has
classified as a pandemic, has prompted governments and regulatory
bodies throughout the world to issue “stay-at-home” or
similar orders, and enact restrictions on the performance of
“non-essential” services, public gatherings and
travel.
Beginning
in March 2020, we undertook precautionary measures intended to help
minimize the risk of the virus to our employees, including
requiring most employees to work remotely, pausing all
non-essential travel worldwide for our employees, and limiting
employee attendance at industry events and in-person work-related
meetings, to the extent those events and meetings are continuing.
As a cash-conserving measure taken in light of the adverse economic
conditions caused by the COVID-19 pandemic, in April 2020 we
reduced the cash salaries of members of management by 33% for the
remainder of 2020, including the salaries of our executive
officers. In lieu of cash, the Company is paying this portion of
management salaries in the form of restricted stock units that vest
over the remainder of the year. Additionally, we amended our
Non-Employee Director Compensation Policy to provide that our
non-employee directors’ annual retainers for the second,
third and fourth fiscal quarters of 2020 shall be paid in in the
form of restricted stock units rather than cash. To date we do not
believe these actions have had a significant negative impact on our
operations. However, these actions or additional measures we may
undertake may ultimately delay progress on our developmental goals
or otherwise negatively affect our business. In addition,
third-party actions taken to contain its spread and mitigate its
public health effects of COVID-19 may negatively affect our
business.
Nasdaq Capital Market Listing
Our
common stock is currently traded on the Nasdaq Capital Market. The
Nasdaq Capital Market imposes, among other requirements, listing
maintenance standards including minimum bid price and
stockholders’ equity requirements. In particular, Nasdaq
rules require a listed company’s primary equity securities to
have a minimum bid price of at least $1.00 per share. On April
24, 2020, we received a notification letter from the Listing
Qualifications Department of The Nasdaq Stock Market LLC
(“Nasdaq”) notifying us that, because the
closing bid price for our common stock listed on Nasdaq
was below $1.00 for 30 consecutive trading days, we no longer met
the minimum bid price requirement for continued listing on The
Nasdaq Capital Market under Nasdaq Marketplace Rule
5550(a)(2).
The
notification has no immediate effect on the listing of our common
stock. In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A) and
the rule change filed by Nasdaq with the Securities and Exchange
Commission on April 16, 2020, we have a period of 180 calendar days
from July 1, 2020, or until December 28, 2020, to regain compliance
with the minimum bid price requirement. The notification
letter also stated that, in the event we do not regain compliance
with the minimum bid price requirement by December 28,
2020, we may be eligible for additional time. To qualify for
additional time, we would be required to meet the continued listing
requirement for market value of publicly held shares and all other
initial listing standards for The Nasdaq Capital Market, with the
exception of the bid price requirement, and would need to
provide written notice of our intention to cure the deficiency
during the second compliance period, by effecting a reverse stock
split, if necessary. If we meet these requirements, Nasdaq will
inform us that we have been granted an additional 180 calendar days
to regain compliance. However, if it appears to the staff of Nasdaq
(the “Staff”) that we will not be able to cure the
deficiency, or if we are otherwise not eligible, the Staff would
notify us that our securities will be subject to delisting. In the
event of such notification, we may appeal the Staff’s
determination to delist its securities, but there can be no
assurance the Staff would grant our request for continued
listing.
We
intend to continue actively monitoring the bid price for our common
stock between now and December 28, 2020 and will consider available
options to resolve the deficiency and regain compliance with
the minimum bid price requirement.
Off-Balance Sheet Transactions
At June
30, 2020, the Company did not have any transactions, obligations or
relationships that could be considered off-balance sheet
arrangements.
27
Item 3. Quantitative and Qualitative Disclosure About Market
Risk
As a
smaller reporting company, we are not required to provide the
information required by this Item 3.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this Form 10-Q, management
performed, with the participation of our principal executive
officer and principal financial officer, an evaluation of the
effectiveness of our disclosure controls and procedures as defined
in Rules 13a-15(e) and 15d-15(e) of the Securities and Exchange Act
of 1934, as amended (the “Exchange Act”). Our
disclosure controls and procedures are designed to ensure that
information required to be disclosed in the reports we file or
submit under the Exchange Act is recorded, processed, summarized,
and reported within the time periods specified in the SEC’s
forms, and that such information is accumulated and communicated to
our management, including our principal executive officer and
principal financial officer, to allow timely decisions regarding
required disclosures. Based on the evaluation, our principal
executive officer and principal financial officer concluded that,
as of June 30, 2020, our disclosure controls and procedures were
not effective.
A material weakness is a deficiency, or a combination of
deficiencies, in internal control over financial reporting, such
that there is a reasonable possibility that a material misstatement
of our annual or interim financial statements will not be prevented
or detected on a timely basis. We identified the following material
weakness as of June 30, 2020: insufficient personnel resources
within the accounting function to segregate the duties over
financial transaction processing and reporting.
To remediate our internal control weaknesses, management intends to
implement the following measures, as finances allow:
● Adding sufficient
accounting personnel or outside consultants to properly segregate
duties and to effect a timely, accurate preparation of the
financial statements.
● Upon the hiring of
additional accounting personnel or outside consultants, develop and
maintain adequate written accounting policies and
procedures.
The
additional hiring is contingent upon our efforts to obtain
additional funding and the results of our operations. Management
expects to secure funds in the coming fiscal year but provides no
assurances that it will be able to do so.
Changes in Internal Control over Financial Reporting
There
were no changes to our internal control over financial reporting or
in other factors that could affect these controls during the three
months ended June 30, 2020 that has materially affected, or
is reasonably likely to materially affect, our internal control
over financial reporting. However, our management is currently
seeking to improve our controls and procedures in an effort to
remediate the deficiency described above.
28
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
We are
not currently a party to any pending legal proceedings that we
believe will have a material adverse effect on our business or
financial condition. We may, however, be subject to various claims
and legal actions arising in the ordinary course of business from
time to time.
Item 1A. Risk Factors
In
addition to the risk factors and uncertainties described below and
the other information set forth in this report, you should
carefully consider the factors discussed under “Risk
Factors” in our Annual Report on Form 10-K for the period
ended December 31, 2019, as filed with the Securities and Exchange
Commission on March 26, 2020. These factors could materially
adversely affect our business, financial condition, liquidity,
results of operations and capital position, and could cause our
actual results to differ materially from our historical results or
the results contemplated by any forward-looking statements
contained in this report.
We will need to raise additional capital to meet our business
requirements in the future and such capital raising may be costly
or difficult to obtain and could dilute current stockholders’
ownership interests.
We have a history of losses from operations and expect to continue
to incur losses until we are able to significantly grow our
revenues. During the quarter ended June 30, 2020 we had an
operating loss of $2.9 million and, as of August 13, 2020, we had
approximately $2,413,762 in cash. Accordingly, we will need
additional financing to maintain our business and execute our
business plan. Such financing may not be available on favorable
terms, if at all.
If we are unable to obtain such additional financing on a timely
basis, we may have to curtail our development activities and growth
plans and/or be forced to sell assets, perhaps on unfavorable
terms, which would have a material adverse effect on our business,
financial condition and results of operations, and ultimately could
be forced to discontinue our operations and liquidate, in which
event it is unlikely that stockholders would receive any
distribution on their shares. See “Item 2. Management’s
Discussion and Analysis of Financial Condition and Results of
Operations—Liquidity and Capital Resources”
above.
Any additional capital raised through the sale of equity or
equity-linked securities may dilute current stockholders’
ownership percentages and could also result in a decrease in the
market value of our equity securities. Additionally, the terms of
any securities issued by us in future capital transactions may be
more favorable to new investors, and may include preferences,
superior voting rights and the issuance of warrants or other
derivative securities, which may have a further dilutive effect on
the holders of any of our securities then outstanding.
In addition, we may incur substantial costs in pursuing future
capital financing, including investment banking fees, legal fees,
accounting fees, securities law compliance fees, printing and
distribution expenses and other costs. We may also be required to
recognize non-cash expenses in connection with certain securities
we issue, such as convertible promissory notes and warrants, which
may adversely impact our financial results.
If we fail to regain compliance with the minimum closing bid
requirement and maintain compliance with the Stockholders’
Equity requirements of the Nasdaq Capital Market or to satisfy
other requirements for continued listing, our common stock may be
delisted and the price of our common stock and our ability to
access the capital markets could be negatively
impacted.
Our
common stock is listed for trading on the Nasdaq Capital Market. To
maintain this listing, we must satisfy Nasdaq’s continued
listing requirements, including, among other things, a minimum
closing bid price requirement of $1.00 per share
under Nasdaq Listing Rule 5550(a)(2) (the
“Bid Price Rule”) and minimum
stockholders’ equity of $2.5 million under Nasdaq Listing
Rule 5550(b)(1) (the “Equity Rule”).
On
April 24, 2020, we received a notification letter
from Nasdaq informing us that for 30 consecutive business
days, the bid price of our common stock had closed
below $1.00 per share. This notice had no immediate effect on
our Nasdaq listing, and we had 180 calendar days from
July 1, 2020, or until December 28, 2020, to regain
compliance.
The
closing bid price of our common stock must be at least $1.00 per
share for a minimum of ten consecutive business days to regain
compliance with the Bid Price Rule. If by December 28, 2020 we have
not regained compliance with the bid price requirement, a second
180-day compliance period may be available, provided (i) we meet
the continued listing requirement for market value of publicly held
shares and all other applicable requirements for initial listing on
Nasdaq (except for the bid price requirement), and (ii) we provide
written notice to Nasdaq of our intention to cure this deficiency
during the second compliance period by effecting a reverse stock
split, if necessary.
Additionally,
as of June 30, 2020 we did not satisfy the Equity Rule due to
shareholders’ equity at that time being less than $2.5
million. Since that time, our shareholders’ equity increased
to $3.4 million as of August 13, 2020 as a result of cash proceeds
from the exercise of warrants and sales of common stock from out
ATM Agreement. Although we had regained compliance with the Equity
Rule as of such date, Nasdaq may still issue us a notification
letter relating to the failure to satisfy the Equity Rule as of
June 30, 2020 and there is no guarantee that we will maintain
compliance with the Equity Rule in the future.
If we
are unable to regain compliance with
the Bid Price Rule by December 28, 2020 or if we
fail to maintain compliance with any of the other continued listing
requirements, including the Equity Rule, our common stock may be
delisted from Nasdaq, which could materially reduce the liquidity
of our common stock and result in a corresponding material
reduction in the price of our common stock. In addition, delisting
could harm our ability to raise capital through alternative
financing sources on terms acceptable to us, or at all, and may
result in the potential loss of confidence by investors, employees
and business development opportunities. Further, if we were to be
delisted from Nasdaq, our common stock may no longer be recognized
as a “covered security” and we would be subject to
regulation in each state in which we offer our securities. Thus,
delisting from Nasdaq could adversely affect our ability to raise
additional financing through the public or private sale of equity
securities, would significantly impact the ability of investors to
trade our securities and would negatively impact the value and
liquidity of our common stock.
29
The outbreak of the novel strain of coronavirus, SARS-CoV-2, which
causes COVID-19, could adversely impact our business, including our
pre-sales activities, clinical trials and ability to obtain
regulatory approvals.
Public
health crises such as pandemics or similar outbreaks could
adversely impact our business. In December 2019, a novel strain of
coronavirus, SARS-CoV-2, which causes coronavirus disease 2019
(“COVID-19”), surfaced in Wuhan, China. Since then,
COVID-19 has spread to countries around the world and has been
declared a pandemic by the World Health Organization. The level and
nature of the disruption caused by COVID-19 is unpredictable, may
be cyclical and long-lasting and may vary from location to
location. Beginning in March 2020, we undertook temporary
precautionary measures to help minimize the risk of the virus to
our employees, including by requiring most employees to work
remotely, pausing all non-essential travel worldwide for our
employees, and limiting employee attendance at industry events and
in-person work-related meetings, to the extent those events and
meetings are continuing. As a cash-conserving measure taken in
light of the adverse economic conditions caused by the COVID-19
pandemic, in April 2020 we reduced the cash salaries of members of
management by 33% for the remainder of 2020, including the salaries
of our executive officers. In lieu of cash, the Company is paying
this portion of management salaries in the form of restricted stock
units that vest over the remainder of the year. Additionally, we
amended our Non-Employee Director Compensation Policy to provide
that our non-employee directors’ annual retainers for the
second, third and fourth fiscal quarters of 2020 shall be paid in
in the form of restricted stock units rather than cash. We may take
additional measures, any of which could negatively affect our
business. In addition, third-party actions taken to contain its
spread and mitigate its public health effects of COVID-19 may
negatively affect our business.
As a
result of the COVID-19 outbreak, or similar pandemics, we have and
may in the future experience disruptions that could severely impact
our business, preclinical studies and clinical trials,
including:
● interruption of key clinical trial activities and
attendance at industry events due to limitations on travel imposed
or recommended by federal or state governments, employers and
others or interruption of clinical trial subject visits and study
procedures;
● delays or difficulties in enrolling patients in
clinical trials of our TAEUS FLIP device;
● interruption or delays in the operations of the
FDA and comparable foreign regulatory agencies, which may impact
approval timelines;
● absenteeism or loss of employees at the Company,
or at our collaborator companies, due to health reasons or
government restrictions or otherwise, that are needed to develop,
validate, manufacture and perform other necessary functions for our
operations;
● supply chain disruptions making it difficult for
our collaborator companies to order and receive materials needed
for the manufacture of our TAEUS product;
● government responses including orders that make
it difficult for us, our supplier and our potential customers to
remain open for business, and other seen and unforeseen actions
taken by government agencies;
● equipment failures, loss of utilities and other
disruptions that could impact our operations or render them
inoperable; and
● effects of a local or global recession or
depression that could depress economic conditions for a prolonged
period and limit access to capital by the
Company.
These
and other factors arising from the COVID-19 pandemic could worsen
in the United States or locally at the location of our offices or
clinical trials, each of which could further adversely impact our
business generally, and could have a material adverse impact on our
operations and financial condition and results.
Item 2. Recent Sales of Unregistered Securities; Use of Proceeds
from Registered Securities
On June
1, 2020, the Company agreed to issue 30,000 shares of common stock
to Trending Equities Corp. for services. In connection with the issuance of
the shares of common stock, the Company relied on
the exemption from registration provided by Section 4(a)(2) of the
Securities Act of 1933, as amended, for transactions not involving
a public offering.
Item 3. Defaults Upon Senior Securities
Not
applicable.
Item 4. Mine Safety Disclosures
Not
applicable.
Item 5. Other Information
Not
applicable.
30
Item 6. Exhibits
Exhibit Number
|
|
Description
|
|
Fourth
Amended and Restated Certificate of Incorporation of the Company
(incorporated by reference to Exhibit 3.2 to the Company’s
Current Report on Form 8-K filed on May 12, 2017)
|
|
|
Certificate
of Amendment to the Fourth Amended and Restated Certificate of
Incorporation of the Company (incorporated by reference to Exhibit
3.1 to the Company’s Current Report on Form 8-K filed on June
18, 2020).
|
|
|
Amended
and Restated Bylaws of the Company (incorporated by reference to
Exhibit 3.4 to the Company’s Registration Statement on Form
S-1 (File No. 333-214724), as amended, originally filed on November
21, 2016)
|
|
|
Specimen
Certificate representing shares of common stock of the Company
(incorporated by reference to Exhibit 4.1 to the Company’s
Registration Statement on Form S-1 (File No. 333-214724), as
amended, originally filed on November 21, 2016)
|
|
|
Certificate
of Designations of Series A Convertible Preferred Stock
(incorporated by reference to Exhibit 4.1 to the Company’s
Current Report on Form 8-K filed on December 11, 2019)
|
|
|
Form of
Warrant issued in December 2019 Series A Convertible Preferred
Stock Offering (incorporated by reference to Exhibit 4.2 to the
Company’s Current Report on Form 8-K filed on December 11,
2019)
|
|
|
Certificate
of Designations of Series B Convertible Preferred Stock
(incorporated by reference to Exhibit 4.1 to the Company’s
Current Report on Form 8-K filed on December 26, 2019)
|
|
|
Form of
Warrant issued in December 2019 Series B Convertible Preferred
Stock Offering (incorporated by reference to Exhibit 4.2 to the
Company’s Current Report on Form 8-K filed on December 26,
2019)
|
|
|
U.S.
Small Business Administration Paycheck Protection Program Note,
issued by the Company to First Republic Bank (incorporated by
reference to Exhibit 10.2 to the Company’s Quarterly Report
on Form 10-Q filed on May 14, 2020)
|
|
|
Non-Employee
Director Compensation Policy* (filed herewith)
|
|
|
Certification
of Periodic Report by Chief Executive Officer pursuant to Rule
13a-14(a)/15d-14a and pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002 (filed herewith)
|
|
|
Certification
of Periodic Report by Chief Financial Officer pursuant to Rule
13a-14(a)/15d-14a and pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002 (filed herewith)
|
|
|
Certification
of Periodic Report by Chief Executive Officer and Chief Financial
Officer pursuant to U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (furnished
herewith)
|
|
101.INS
|
|
XBRL
Instance Document (filed herewith)
|
101.SCH
|
|
XBRL
Taxonomy Schema (filed herewith)
|
101.CAL
|
|
XBRL
Taxonomy Extension Calculation Linkbase (filed
herewith)
|
101.DEF
|
|
XBRL
Taxonomy Extension Definition Linkbase (filed
herewith)
|
101.LAB
|
|
XBRL
Taxonomy Extension Label Linkbase (filed herewith)
|
101.PRE
|
|
XBRL
Taxonomy Extension Presentation Linkbase (filed
herewith)
|
*
Indicates management compensatory plan, contract or
arrangement.
31
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned, thereunto duly
authorized.
|
ENDRA LIFE SCIENCES INC.
|
|
|
|
|
|
|
Date:
August 14, 2020
|
By:
|
/s/ Francois
Michelon
|
|
|
|
Francois
Michelon
|
|
|
|
Chief
Executive Officer and Chairman
(Principal
Executive Officer)
|
|
|
ENDRA LIFE SCIENCES INC.
|
|
|
|
|
|
|
Date:
August 14, 2020
|
By:
|
/s/ David
Wells
|
|
|
|
David
Wells
|
|
|
|
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
|
|
32