Filed Pursuant to
Rule 424(b)(3)
Registration No.
333-223895
PROSPECTUS SUPPLEMENT NO. 9
(To Prospectus Dated April 17, 2018)

EMERALD BIOSCIENCE, INC.
Up to 140,694,163 Shares of
Common Stock
This
prospectus supplement no. 9 supplements the prospectus dated April
17, 2018, relating to the resale by the selling shareholders
identified in such prospectus of up to 140,694,163 shares of common
stock of Emerald Bioscience, Inc., $0.001 par value (the “Common
Stock”), including (i) 32,500,000 shares of Common Stock and
44,200,000 shares of Common Stock issuable upon exercise of
warrants, which we sold to investors in a private placement on
January 19, 2018 and February 16, 2018, (ii) 9,000,000 shares of
Common Stock issued upon conversion of a secured promissory note
for a convertible loan on January 19, 2018, (iii) 20,000,000 shares
of Common Stock, which equals the number of shares of Common Stock
issued upon the conversion of shares of our Series F Convertible
Preferred Stock, par value $0.001 per share (“Series F Preferred
Stock”), (iv) 2,000,000 shares of Common Stock, which equals the
number of shares of Common Stock issued upon the conversion of
shares of our Series D Convertible Preferred Stock, par value
$0.001 per share (“Series D Preferred Stock”), (v) 28,335,000
shares of Common Stock issued upon the conversion of shares of our
Series B Convertible Preferred Stock, par value $0.001 per share
(“Series B Preferred Stock”), 1,781,250 shares of Common Stock
issued upon the exercise of the warrants which we sold to investors
in a private placement on August 20, 2015 and 1,843,750 shares of
Common Stock issuable upon exercise of the warrants which we sold
to investors in a private placement on August 20, 2015, (vi)
241,663 shares of Common Stock which we sold to investors in a
private placement on January 7, 2015 and (vii) 792,500 shares of
Common Stock issuable upon exercise of warrants issued to our
placement agents.
This
prospectus supplement incorporates into our prospectus the
information contained in our attached Quarterly Report on Form
10-Q, which was filed with the Securities and Exchange Commission
on May 8, 2020.
You
should read this prospectus supplement in conjunction with the
prospectus, including any supplements and amendments thereto. This
prospectus supplement is qualified by reference to the prospectus
except to the extent that the information in the prospectus
supplement supersedes the information contained in the
prospectus.
This
prospectus supplement is not complete without, and may not be
delivered or utilized except in connection with, the prospectus,
including any supplements and amendments thereto.
You should carefully consider matters
discussed under the caption “Risk Factors” beginning on page 7 of
the prospectus. Neither the Securities and Exchange Commission nor
any state securities commission has approved or disapproved of
these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The date of this
prospectus supplement is May 8, 2020.
UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
|
|
|
For the quarterly
period ended March 31, 2020
|
or
¨
|
TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
|
|
|
For the transition
period from ___________ to ___________
|
Commission File Number:
000-55136
Emerald Bioscience, Inc.
|
(Exact name of
registrant as specified in its charter)
|
Nevada
|
|
45-0692882
|
(State or other
jurisdiction
of incorporation or
organization)
|
|
(I.R.S. Employer
Identification No.)
|
130 North
Marina Drive, Long Beach, CA 90803
|
(Address of principal
executive offices) (Zip Code)
|
(949)
336-3443
|
(Registrant’s telephone
number, including area code)
|
_____________________________________________
(Former name, former
address and former fiscal year, if changed since last report)
Securities registered
pursuant to Section 12(b) of the Act:
Title of each class
|
|
Trading Symbol(s)
|
|
Name of each
exchange
on which registered
|
None
|
|
None
|
|
None
|
Securities registered
pursuant to Section 12(g) of the Act:
Title of each class
|
|
Trading Symbol(s)
|
|
Name of each
exchange
on which registered
|
Common Stock, par value
$0.001
|
|
EMBI
|
|
OTCQB
|
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.
x
Yes o 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). x Yes ☐
No
Indicate by check mark
whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, a 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
|
o
|
Accelerated filer
|
o
|
Non-accelerated
filer
|
x
|
Smaller reporting
company
|
x
|
|
Emerging growth
company
|
o
|
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. o
Indicate by check mark
whether the registrant is a shell company (as defined in Rule 12b-2
of the Exchange Act). o
Yes x No
As of May 7, 2020,
there were 183,207,747 shares of the issuer’s $0.001 par value
common stock issued and outstanding.
TABLE OF
CONTENTS
FORWARD-LOOKING
STATEMENTS
Statements in this
Quarterly Report on Form 10-Q that are not descriptions of
historical facts are forward-looking statements that are based on
management’s current expectations and assumptions and are subject
to risks and uncertainties. If such risks or uncertainties
materialize or such assumptions prove incorrect, our business,
operating results, financial condition and stock price could be
materially negatively affected. In some cases, you can identify
forward-looking statements by terminology including “anticipates,”
“believes,” “can,” “continue,” “could,” “estimates,” “expects,”
“intends,” “may,” “plans,” “potential,” “predicts,” “should,”
“will,” “would” or the negative of these terms or other comparable
terminology. Factors that could cause actual results to differ
materially from those currently anticipated include those set forth
in the section titled “Risk Factors” including, without limitation,
risks relating to:
|
·
|
the results of our
research and development activities, including uncertainties
relating to the discovery of potential product candidates and the
preclinical and clinical testing of our product candidates;
|
|
·
|
the early stage of our
product candidates presently under development;
|
|
·
|
our need for
substantial additional funds in order to continue our operations,
and the uncertainty of whether we will be able to obtain the
funding we need;
|
|
·
|
our ability to obtain
and, if obtained, maintain regulatory approval of our current
product candidates, and any of our other future product candidates,
and any related restrictions, limitations, and/or warnings in the
label of any approved product candidate;
|
|
·
|
our ability to retain
or hire key scientific or management personnel;
|
|
·
|
our ability to protect
our intellectual property rights that are valuable to our business,
including patent and other intellectual property rights;
|
|
·
|
our dependence on the
University of Mississippi, third-party manufacturers, suppliers,
research organizations, testing laboratories and other potential
collaborators;
|
|
·
|
our ability to develop
successful sales and marketing capabilities in the future as
needed;
|
|
·
|
the size and growth of
the potential markets for any of our approved product candidates,
and the rate and degree of market acceptance of any of our approved
product candidates;
|
|
·
|
competition in our
industry;
|
|
·
|
the duration and impact
of the novel coronavirus (“COVID-19”) pandemic; and
|
|
·
|
regulatory developments
in the United States and foreign countries.
|
We operate in a
rapidly-changing environment and new risks emerge from time to
time. As a result, it is not possible for our management to predict
all risks, such as the COVID-19 outbreak and associated business
disruptions including delayed clinical trials and laboratory
resources, nor can we assess the impact of all factors on our
business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those
contained in any forward-looking statements we may make. In light
of these risks, uncertainties and assumptions, the forward-looking
events and circumstances discussed in this report may not occur and
actual results could differ materially and adversely from those
anticipated or implied in the forward-looking statements. You
should not rely upon forward-looking statements as predictions of
future events. Although we believe that the expectations reflected
in the forward-looking statements are reasonable, we cannot
guarantee that the future results, levels of activity, performance
or events and circumstances reflected in the forward-looking
statements will be achieved or occur. Moreover, neither we nor any
other person assumes responsibility for the accuracy and
completeness of the forward-looking statements. The forward-looking
statements included in this report speak only as of the date
hereof, and except as required by law, we undertake no obligation
to update publicly any forward-looking statements for any reason
after the date of this report to conform these statements to actual
results or to changes in our expectations.
PART I - FINANCIAL
INFORMATION
Item 1. Financial
Statements
|
|
March
31,
2020
(Unaudited)
|
|
|
December
31,
2019
(Note
2)
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash
|
|
$ |
563,864 |
|
|
$ |
1,829,977 |
|
Restricted cash
|
|
|
4,538 |
|
|
|
4,538 |
|
Prepaid expenses
|
|
|
99,067 |
|
|
|
152,695 |
|
Other current assets
|
|
|
3,888 |
|
|
|
7,550 |
|
Total current assets
|
|
|
671,357 |
|
|
|
1,994,760 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net
|
|
|
1,618 |
|
|
|
1,983 |
|
Total assets
|
|
$ |
672,975 |
|
|
$ |
1,996,743 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' (DEFICIT) EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
937,266 |
|
|
$ |
129,809 |
|
Accounts payable to related party
|
|
|
40,903 |
|
|
|
10,000 |
|
Accrued interest due to related party
|
|
|
35,645 |
|
|
|
- |
|
Other current liabilities
|
|
|
405,344 |
|
|
|
420,406 |
|
Derivative liabilities
|
|
|
248,052 |
|
|
|
410,603 |
|
Total current liabilities
|
|
|
1,667,210 |
|
|
|
970,818 |
|
|
|
|
|
|
|
|
|
|
Noncurrent
liabilities
|
|
|
|
|
|
|
|
|
Convertible multi-draw credit agreement - related party, net of
discount
|
|
|
517,780 |
|
|
|
387,070 |
|
Derivative liabilities, non-current
|
|
|
190,882 |
|
|
|
90,797 |
|
Total liabilities
|
|
|
2,375,872 |
|
|
|
1,448,685 |
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
(deficit) equity
|
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 20,000,000 shares authorized; no
shares issued and outstanding at March 31, 2020 and December 31,
2019
|
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par
value; 500,000,000 shares authorized; 183,207,747 and 182,895,247
shares issued and outstanding at March 31, 2020 and December 31,
2019, respectively
|
|
|
183,208 |
|
|
|
182,895 |
|
Additional paid-in-capital
|
|
|
32,628,837 |
|
|
|
32,538,445 |
|
Accumulated deficit
|
|
|
(34,514,942 |
) |
|
|
(32,173,282 |
) |
Total stockholders’ (deficit) equity
|
|
|
(1,702,897 |
) |
|
|
548,058 |
|
Total liabilities and stockholders’ (deficit) equity
|
|
$ |
672,975 |
|
|
$ |
1,996,743 |
|
|
|
|
|
|
|
|
|
|
See accompanying notes
to the condensed consolidated financial statements.
|
EMERALD
BIOSCIENCE, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
(UNAUDITED)
|
|
For the Three
Months Ended
March
31,
|
|
|
|
2020
|
|
|
2019
|
|
Operating
expenses
|
|
|
|
|
|
|
Research and development
|
|
$ |
799,612 |
|
|
$ |
320,986 |
|
General and administrative
|
|
|
1,411,596 |
|
|
|
1,194,081 |
|
Total operating expenses
|
|
|
2,211,208 |
|
|
|
1,515,067 |
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(2,211,208 |
) |
|
|
(1,515,067 |
) |
|
|
|
|
|
|
|
|
|
Other expense
(income)
|
|
|
|
|
|
|
|
|
Change in fair value of derivative liabilities
|
|
|
(35,903 |
) |
|
|
12,820,618 |
|
Fair value of derivative liabilities in excess of proceeds
|
|
|
- |
|
|
|
322,644 |
|
Interest expense
|
|
|
166,355 |
|
|
|
116,063 |
|
Total other expense, net
|
|
|
130,452 |
|
|
|
13,259,325 |
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss
|
|
$ |
(2,341,660 |
) |
|
$ |
(14,774,392 |
) |
|
|
|
|
|
|
|
|
|
Loss per common
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(0.01 |
) |
|
$ |
(0.11 |
) |
Diluted
|
|
$ |
(0.01 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average shares of common stock outstanding used to compute loss per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
182,256,966 |
|
|
|
132,729,246 |
|
Diluted
|
|
|
183,737,415 |
|
|
|
132,729,246 |
|
|
See accompanying notes
to the condensed consolidated financial statements.
|
EMERALD
BIOSCIENCE, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
|
|
For the Three
Months Ended
March
31,
|
|
|
|
2020
|
|
|
2019
|
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
Net loss
|
|
$ |
(2,341,660 |
) |
|
$ |
(14,774,392 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
365 |
|
|
|
366 |
|
Stock-based compensation expense
|
|
|
64,142 |
|
|
|
171,493 |
|
Change in fair value of derivative liabilities
|
|
|
(35,903 |
) |
|
|
12,820,618 |
|
Fair value of derivative liabilities in excess of proceeds
|
|
|
- |
|
|
|
322,644 |
|
Amortization of debt discount
|
|
|
130,710 |
|
|
|
56,952 |
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
|
|
Prepaid expenses
|
|
|
53,628 |
|
|
|
(208,619 |
) |
Other current assets
|
|
|
3,662 |
|
|
|
- |
|
Accounts payable
|
|
|
807,457 |
|
|
|
152,684 |
|
Accounts payable to related party
|
|
|
30,903 |
|
|
|
- |
|
Accrued interest due to related party
|
|
|
35,645 |
|
|
|
- |
|
Other current liabilities
|
|
|
(15,062 |
) |
|
|
27,134 |
|
Net cash used in operating activities
|
|
|
(1,266,113 |
) |
|
|
(1,431,120 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
|
Proceeds from convertible multi-draw credit agreement - related
party, net of issuance costs
|
|
|
- |
|
|
|
3,990,699 |
|
Net cash provided by financing activities
|
|
|
- |
|
|
|
3,990,699 |
|
|
|
|
|
|
|
|
|
|
Net (decrease)
increase in cash and restricted cash
|
|
|
(1,266,113 |
) |
|
|
2,559,579 |
|
|
|
|
|
|
|
|
|
|
Cash and
restricted cash, beginning of year
|
|
$ |
1,834,515 |
|
|
$ |
1,857,885 |
|
|
|
|
|
|
|
|
|
|
Cash and
restricted cash, end of year
|
|
$ |
568,402 |
|
|
$ |
4,417,464 |
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosures of cash-flow information:
|
|
|
|
|
|
|
|
|
Reconciliation of cash
and restricted cash:
|
|
|
|
|
|
|
|
|
Cash
|
|
$ |
563,864 |
|
|
$ |
4,412,952 |
|
Restricted cash
|
|
|
4,538 |
|
|
|
4,512 |
|
Total cash and restricted cash shown in the consolidated statements
of cash flows
|
|
$ |
568,402 |
|
|
$ |
4,417,464 |
|
|
|
|
|
|
|
|
|
|
Cash paid during the
year for:
|
|
|
|
|
|
|
|
|
Interest
|
|
$ |
- |
|
|
$ |
59,111 |
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosures of non-cash financing activities:
|
|
|
|
|
|
|
|
|
Beneficial conversion feature on convertible multi-draw credit
agreement
|
|
$ |
- |
|
|
$ |
1,584,850 |
|
Proceeds allocated to equity classified warrants issued with
convertible multi-draw credit agreement
|
|
|
- |
|
|
|
716,110 |
|
Fair value of compound derivative liability bifurcated from
convertible multi-draw credit agreement
|
|
|
- |
|
|
|
193,414 |
|
Reclassification of warrant liabilities to equity from exercise of
warrants
|
|
|
26,563 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
See accompanying notes
to the condensed consolidated financial statements.
|
EMERALD BIOSCIENCE, INC. AND SUBSIDIARIES
|
CONDENSED CONSOLIDATED STATEMENTS OF
STOCKHOLDERS' EQUITY (DEFICIT)
|
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
Additional
Paid-In
|
|
|
Accumulated
|
|
|
Total
Stockholders'
|
|
|
|
Shares
|
|
|
Amounts
|
|
|
Capital
|
|
|
Deficit
|
|
|
Deficit
|
|
Balance, January 1, 2019
|
|
|
133,907,747 |
|
|
$ |
133,908 |
|
|
$ |
17,528,947 |
|
|
$ |
(33,225,107 |
) |
|
$ |
(15,562,252 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
expense
|
|
|
- |
|
|
|
- |
|
|
|
171,493 |
|
|
|
- |
|
|
|
171,493 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants issued in connection with
convertible multi-draw credit agreement, related party
|
|
|
- |
|
|
|
- |
|
|
|
716,110 |
|
|
|
- |
|
|
|
716,110 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Beneficial conversion feature in connection
with convertible multi-draw credit agreement - related party
|
|
|
- |
|
|
|
- |
|
|
|
1,584,850 |
|
|
|
- |
|
|
|
1,584,850 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the three months
ended March 31, 2019
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(14,774,392 |
) |
|
|
(14,774,392 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31,
2019
|
|
|
133,907,747 |
|
|
$ |
133,908 |
|
|
$ |
20,001,400 |
|
|
$ |
(47,999,499 |
) |
|
$ |
(27,864,191 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
Additional
Paid-In
|
|
|
Accumulated
|
|
Total
Stockholders'
Equity
|
|
|
Shares
|
|
|
Amounts
|
|
|
Capital
|
|
|
Deficit
|
|
|
(Deficit)
|
|
Balance, January 1,
2020
|
|
|
182,895,247 |
|
|
$ |
182,895 |
|
|
$ |
32,538,445 |
|
|
$ |
(32,173,282 |
) |
|
$ |
548,058 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense
|
|
|
- |
|
|
|
- |
|
|
|
64,142 |
|
|
|
- |
|
|
|
64,142 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series B warrant exercises
|
|
|
312,500 |
|
|
|
313 |
|
|
|
26,250 |
|
|
|
- |
|
|
|
26,563 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the three months ended March 31,
2020
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(2,341,660 |
) |
|
|
(2,341,660 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31,
2020
|
|
|
183,207,747 |
|
|
$ |
183,208 |
|
|
$ |
32,628,837 |
|
|
$ |
(34,514,942 |
) |
|
$ |
(1,702,897 |
) |
See
accompanying notes to the condensed consolidated financial
statements.
EMERALD
BIOSCIENCE, INC. AND SUBSIDIARIES
NOTES TO
THE CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
(UNAUDITED)
1. Nature of Operations and Business
Activities
Nature of Operations
Emerald
Bioscience, Inc. (the “Company”) was initially incorporated in
Nevada on March 16, 2011 as Load Guard Logistics, Inc. On October
31, 2014, the Company closed a reverse merger transaction (the
“Merger”) pursuant to which Nemus, a California corporation (“Nemus
Sub”), became the Company’s wholly-owned subsidiary, and the
Company assumed the operations of Nemus Sub. Nemus Sub was
incorporated in the State of California on July 17, 2012. On
November 3, 2014, the Company changed its name to Nemus Bioscience,
Inc. by merging with Nemus Sub.
In
January 2018, the Company entered into a securities purchase
agreement with Emerald Health Sciences, Inc. (“Emerald Health
Sciences”), pursuant to which Emerald Health Sciences purchased a
majority of the equity interest in the Company, resulting in a
change in control (the “Emerald Financing”). As part of the
transaction, the Company’s Board members, with the exception of Dr.
Brian Murphy, the Company’s CEO/CMO, tendered their resignation and
Emerald Health Sciences appointed two new nominees to the Board.
Later, in October 2018, the Board appointed Dr. Avtar Dhillon, the
Chairman, Chief Executive Officer and President of Emerald Health
Sciences, as the Executive Chairman of the Company’s Board.
On
February 11, 2019, the Company’s Board of Directors (the “Board”)
and majority stockholder unanimously approved an amendment to the
Company’s articles of incorporation to change the name of the
Company to Emerald Bioscience, Inc. Effective March 25, 2019, the
Company filed a Certificate of Amendment with the Nevada Secretary
of State changing the Company’s name to Emerald Bioscience,
Inc.
In
August 2019, the Company formed a new subsidiary in Australia, EMBI
Australia Pty Ltd., an Australian proprietary limited company
(“EMBI Australia”), in order to qualify for the Australian
government’s research and development tax credit for research and
development dollars spent in Australia. The primary purpose of EMBI
Australia is to conduct clinical trials for the Company’s product
candidates.
On
December 17, 2019, Dr. Avtar Dhillon resigned as the Chairman of
the Company’s Board and the Company entered into a Board Observer
Agreement with Emerald Health Sciences. Refer to Note 7 - Related
Party Matters for additional information.
The
Company is a biopharmaceutical company located in Long Beach,
California that plans to research, develop and commercialize
therapeutics derived from cannabinoids through several license
agreements with the University of Mississippi (“UM”). UM is the
only entity federally permitted and licensed to cultivate cannabis
for research purposes in the United States.
As of
March 31, 2020, the Company has devoted substantially all its
efforts to securing product licenses, carrying out research and
development, building infrastructure and raising capital. The
Company has not yet realized revenue from its planned principal
operations and is a number of years from potentially being able to
do so.
Liquidity and Going Concern
The
Company has incurred operating losses and negative cash flows from
operations since inception and as of March 31, 2020, had an
accumulated deficit of $34,514,942, a stockholders’ deficit of
$1,702,897 and a working capital deficit of $995,853. The Company
anticipates that it will continue to incur operating losses and
negative cash flows from operations into the foreseeable future in
order to advance and develop a number of potential drug candidates
into preclinical and clinical development activities and support
its corporate infrastructure which includes the costs associated
with being a public company. As of March 31, 2020, the Company had
unrestricted cash in the amount of $563,864 as compared to
$1,829,977 as of December 31, 2019. As of the date of this filing
the Company’s unrestricted cash position has decreased further to
$228,000 plus an additional $87,000 of restricted cash including
$82,000 of remaining funds from a recently funded Paycheck
Protection Program Promissory Note (the “PPP Note”) as discussed
below.
As the
Company approaches its first clinical trial, it expects to ramp up
research and development spending and projects to increase cash
used in operating activities. However, based on the Company’s
current cash position and expected cash requirements, without
obtaining additional funding during the second quarter of 2020,
management believes that the Company will not have enough funds to
meet its current obligations or commence clinical studies. These
conditions give rise to substantial doubt as to the Company’s
ability to continue as a going concern. The accompanying Condensed
Consolidated Financial Statements do not include any adjustments
that might result from the outcome of this uncertainty.
The
Company’s continued existence is dependent on its ability to raise
sufficient additional funding to cover operating expenses and to
invest in research and development activities. On October 5, 2018,
the Company entered into a Multi-Draw Credit Agreement (the “Credit
Agreement”) with Emerald Health Sciences (See Note 4).
On April 29, 2020, the
Company entered into an Amended and Restated Multi-Draw Credit
Agreement (the “Amended Credit Agreement”) with Emerald Health
Sciences, which amends and restates the Credit Agreement. The
Amended Credit Agreement provides for a credit facility in the
principal amount of up to $20,000,000, which includes, without
limitation, the advances totaling $6,000,000 that were granted
prior to the amendment and advances of at least $150,000 for each
of May, June and July 2020.
Prior to the date of
the Amended Credit Agreement, the Company had made three drawdowns
in an aggregate principal amount of $6,000,000, and had issued to
Emerald Health Sciences warrants to purchase an aggregate of
7,500,000 shares of common stock of the Company at an exercise
price of $0.50 per share of Common Stock, in accordance with the
terms of the Credit Agreement.
Immediately upon
entering into the Amended Credit Agreement, the Company effected a
fourth advance in the amount of $150,000. The advance bears an
interest at 7% per annum and matures on October 5, 2022. The
Company intends to use the net proceeds of the advance for general
corporate and working capital purposes. The Lender has elected that
the fourth advance will not be convertible into shares of Common
Stock and gave notice to the Company that no warrant will be issued
in connection with the advance at this time.
On April
22, 2020, the Company entered into a Paycheck Protection Program
Promissory Note (the “PPP Note”) in the principal amount of
$116,700 (the “PPP Loan”) from City National Bank (the “PPP Loan
Lender”). The PPP Loan was obtained pursuant to the Paycheck
Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and
Economic Security Act (the “CARES Act”) administered by the U.S.
Small Business Administration (“SBA”). Funds from the PPP Loan may
only be used by the Company for payroll costs, costs for continuing
group healthcare benefits, mortgage interest payments, rent,
utility and interest on any other debt obligations that were
incurred before February 15, 2020. All or a portion of principal of
the PPP Loan may be forgiven by the SBA and the PPP Loan Lender
upon application by the Company within 60 days but not later than
120 days after loan approval and upon documentation of expenditures
in accordance with the SBA requirements.
The
Company plans to continue to pursue funding through public or
private equity or debt financings, licensing arrangements, asset
sales, government grants or other arrangements. However, the
Company cannot provide any assurances that such additional funds
will be available on reasonable terms, or at all. If the Company
raises additional funds by issuing equity securities, substantial
dilution to existing stockholders would result.
Effective
March 23, 2020, the Company approved a plan to defer up to 50% of
the members of senior management’s compensation indefinitely.
Certain members of senior management have accepted the plan and the
aggregate deferred compensation, together with a retention bonus of
10% of the amount being deferred will be payable to senior
management when decided by the Board. Effective March 30, 2020, the
Directors of the Company entered into agreements to defer payment
of 100% of their Board of Director and committee fees indefinitely.
The accrued fees, plus a 10% bonus of such accrued fees will be
payable to the members of the Board within 30 days of the Board of
Directors determining that the Company has been sufficiently
financed to make such payments. These measures, in conjunction with
management’s plan to negotiate extended payment terms with its
vendors and service providers and delay development work in
conjunction with pushing back the initiation of its first-in-human
studies of the lead drug candidate, NB1111, to the 2021 timeframe,
is intended to slow cash burn. The Company’s Board plans on further
assessing the financial condition of the Company to determine what
additional measures, if any, will be implemented. If the Company is
unable to secure adequate additional funding, the Company may be
forced to reduce spending further, liquidate assets where possible,
suspend or curtail planned programs or cease operations.
In
December 2019, a novel strain of coronavirus (“COVID-19”) emerged
in Wuhan, China. Since then, it has spread to the United States and
infections have been reported around the world. On March 11, 2020,
the World Health Organization declared the outbreak of COVID-19 as
a global pandemic, which continues to spread throughout the United
States, Australia and around the world, where the Company has
operations and conducts laboratory research and clinical studies.
In response to the outbreak, federal and state authorities in the
United States have introduced various recommendations and measures
to try to limit the pandemic, including travel restrictions, border
closures, nonessential business closures, quarantines,
self-isolations, shelters-in-place and social distancing. The
COVID-19 outbreak and the response of governmental authorities to
try to limit it are having a significant impact on the private
sector and individuals, including unprecedented business,
employment and significant economic disruptions to the global
financial markets. These disruptions are likely to impact the
Company’s ability to raise additional capital and obtain the
necessary funds.
Notably,
the Company relies on third-party manufacturers to produce its
product candidates. The manufacturing of the active pharmaceutical
ingredient of NB1111 is conducted in the United States. Formulation
of the eye drop for testing is also performed in the United States
but can rely on regulatory-accepted excipients that can be sourced
from countries outside the United States, such as China. In lieu of
the recent pandemic of a COVID-19, there could possibly be an
impact on sourcing materials that are part of the eye drop
formulation, as well as impacting volunteer and/or patient
recruitment in Australia for clinical studies. Therefore, the
Company has shifted its first-in-human studies of NB1111 from the
second half of 2020, to the 2021 timeframe.
After
considering the plans to alleviate substantial doubt, management
has concluded that there is substantial doubt about the Company’s
ability to continue as a going concern within one year after the
date that the financial statements are issued.
2. Summary of Significant Accounting Policies
Basis of Presentation
In the opinion of
management, the accompanying Unaudited Condensed Consolidated
Financial Statements have been prepared on a consistent basis with
the Company’s Audited Consolidated Financial Statements for the
fiscal year ended December 31, 2019, and include all adjustments,
consisting of only normal recurring adjustments, necessary to
fairly state the information set forth herein. The Condensed
Consolidated Financial Statements have been prepared in accordance
with the rules and regulations of the Securities and Exchange
Commission (“SEC”) and therefore, omit certain information and
footnote disclosure necessary to present the financial statements
in accordance with generally accepted accounting principles in the
United States (“GAAP”).
The results of
operations for the three months ended March 31, 2020 are not
necessarily indicative of the results to be expected for the year
ending December 31, 2020 or any future periods. The Condensed
Consolidated Balance Sheet as of December 31, 2019 was derived from
the Company’s audited financial statements as of December 31, 2019,
which are included in the Company’s Annual Report on Form 10-K
filed with the SEC on March 20, 2020. The unaudited financial
statements included in this Quarterly Report on Form 10-Q should be
read in conjunction with the audited consolidated financial
statements and notes thereto included in the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2019,
which includes a broader discussion of the Company’s business and
the risks inherent therein.
Certain
reclassifications have been made to prior year amounts to conform
to the current period’s presentation. Such reclassifications had no
net effect on total assets, total liabilities, total stockholders’
equity, net losses and cash flows.
Use of Estimates
The
preparation of the Condensed Consolidated Financial Statements in
conformity with GAAP requires management to make estimates and
assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at
the date of the Condensed Consolidated Financial Statements and the
reported amounts of income and expense during the reporting period.
Actual results could differ from those estimates. The most
significant accounting estimates inherent in the preparation of the
Company’s financial statements include estimates as to the
appropriate carrying value of certain assets and liabilities, which
are not readily apparent from other sources. Such estimates and
judgments are utilized for stock-based compensation expense, equity
securities, derivative liabilities, and debt with embedded
features.
Risks and Uncertainties
The
Company’s operations are subject to a number of risks and
uncertainties, including but not limited to, changes in the general
economy, the size and growth of the potential markets for any of
the Company’s product candidates, results of research and
development activities, uncertainties surrounding regulatory
developments in the United States and Australia, and the Company’s
ability to attract new funding.
Fair Value Measurements
Certain
assets and liabilities are carried at fair value under GAAP. Fair
value is defined as the exchange price that would be received for
an asset or paid to transfer a liability (the “exit price”) in the
principal or most advantageous market for the asset or liability in
an orderly transaction between market participants on the
measurement date. Valuation techniques used to measure fair value
must maximize the use of observable inputs and minimize the use of
unobservable inputs. A fair value hierarchy based on three levels
of inputs, of which the first two are considered observable, and
the last is considered unobservable, is used to measure fair
value:
Level 1:
|
Valuations for assets
and liabilities traded in active markets from readily available
pricing sources such as quoted prices in active markets for
identical assets or liabilities.
|
|
|
Level 2:
|
Observable inputs
(other than Level 1 quoted prices) such as quoted prices in active
markets for similar assets or liabilities, quoted prices in markets
that are not active for identical or similar assets or liabilities,
or other inputs that are observable or can be corroborated by
observable market data.
|
|
|
Level 3:
|
Unobservable inputs
that are supported by little or no market activity and that are
significant to determining the fair value of the assets or
liabilities, including pricing models, discounted cash flow
methodologies and similar techniques.
|
The
carrying values of the Company’s financial instruments, with the
exception of the Credit Agreement and derivative liabilities,
including, cash, prepaid expenses, accounts payable, and other
current liabilities approximate their fair value due to the short
maturities of these financial instruments. The derivative
liabilities are valued on a recurring basis utilizing Level 3
inputs.
Advances
under the Credit Agreement are not recorded at fair value. However,
fair value can be approximated and disclosed utilizing Level 3
inputs and independent third-party valuation techniques (See Note
3). As of March 31, 2020 and December 31, 2019, the fair value of
the advances under the Credit Agreement was $1,639,245 and
$1,877,938, respectively. The carrying amount of the liability at
March 31, 2020 and December 31, 2019, was $517,780 and $387,070,
respectively, and is included in Convertible multi-draw credit
agreement - related party, net of discount in the Company’s
Condensed Consolidated Balance Sheets.
Convertible Instruments
The
Company accounts for hybrid contracts with embedded conversion
features in accordance with GAAP. ASC 815, Derivatives and
Hedging Activities (“ASC 815”) requires companies to bifurcate
conversion options from their host instruments and account for them
as free-standing derivative financial instruments according to
certain criteria. The criteria includes circumstances in which (a)
the economic characteristics and risks of the embedded derivative
instrument are not clearly and closely related to the economic
characteristics and risks of the host contract, (b) the hybrid
instrument that embodies both the embedded derivative instrument
and the host contract is not re-measured at fair value under
otherwise applicable generally accepted accounting principles with
changes in fair value reported in earnings as they occur and (c) a
separate instrument with the same terms as the embedded derivative
instrument would be considered a derivative instrument.
The
Company accounts for convertible debt instruments with embedded
conversion features in accordance with ASC 470-20, Debt with
Conversion and Other Options (“ASC 470-20”) if it is
determined that the conversion feature should not be bifurcated
from their host instruments. Under ASC 470-20, the Company records,
when necessary, discounts to convertible notes for the intrinsic
value of conversion options embedded in debt instruments based upon
the difference between the fair value of the underlying common
stock at the commitment date and the embedded effective conversion
price. When the Company determines that the embedded conversion
option should be bifurcated from its host instrument, the embedded
feature is accounted for in accordance with ASC 815. Under ASC 815,
a portion of the proceeds received upon the issuance of the hybrid
contract is allocated to the fair value of the derivative. The
derivative is subsequently marked to market at each reporting date
based on current fair value, with the changes in fair value
reported in the results of operations.
The
Company also follows ASC 480-10, Distinguishing Liabilities
from Equity (“ASC 480-10”) when evaluating the accounting for
its hybrid instruments. A financial instrument that embodies an
unconditional obligation, or a financial instrument other than an
outstanding share that embodies a conditional obligation, that the
issuer must or may settle by issuing a variable number of its
equity shares shall be classified as a liability (or an asset in
some circumstances) if, at inception, the monetary value of the
obligation is based solely or predominantly on any one of the
following: (a) a fixed monetary amount known at inception (for
example, a payable settled with a variable number of the issuer’s
equity shares); (b) variations in something other than the fair
value of the issuer’s equity shares (for example, a financial
instrument indexed to the Standard and Poor’s S&P 500 Index and
settled with a variable number of the issuer’s equity shares); or
(c) variations inversely related to changes in the fair value of
the issuer’s equity shares (for example, a written put option that
could be net share settled). Hybrid instruments meeting these
criteria are not further evaluated for any embedded derivatives and
are carried as a liability at fair value at each balance sheet date
with a re-measurement reported in other expense (income) in the
accompanying Condensed Consolidated Statements of Comprehensive
Loss.
When
determining the short-term vs. long-term classification of
derivative liabilities, the Company first evaluates the
instruments’ exercise provisions. Generally, if a derivative is a
liability and exercisable within one year, it will be classified as
short-term. However, because of the unique provisions and
circumstances that may impact the accounting for derivative
instruments, the Company carefully evaluates all factors that could
potentially restrict the instrument from being exercised or create
a situation where exercise would be considered remote. The Company
re-evaluates its derivative liabilities at each reporting period
end and makes updates for any changes in facts and circumstances
that may impact classification.
Warrants Issued in Connection with
Financings
The
Company generally accounts for warrants issued in connection with
debt and equity financings as a component of equity, unless the
warrants include a conditional obligation to issue a variable
number of shares or there is a deemed possibility that the Company
may need to settle the warrants in cash. For warrants issued with a
conditional obligation to issue a variable number of shares or the
deemed possibility of a cash settlement, the Company records the
fair value of the warrants as a liability at each balance sheet
date and records changes in fair value in other expense (income) in
the Condensed Consolidated Statements of Comprehensive Loss.
Debt Issuance Costs and Interest
Discounts
related to bifurcated derivatives, freestanding instruments issued
in bundled transactions, and issuance costs are recorded as a
reduction to the carrying value of the debt and amortized over the
life of the debt using the effective interest method. The Company
makes changes to the effective interest rate, as necessary, on a
prospective basis. For debt facilities that provide for multiple
advances, the Company initially defers any issuance costs until the
first advance is made and then amortizes the costs over the life of
the facility.
Research and Development Expenses and Licensed
Technology
Research
and development costs are expensed when incurred. These costs may
consist of external research and development expenses incurred
under agreements with third-party contract research organizations
and investigative sites, third-party manufacturing organizations
and consultants; license fees; employee-related expenses, which
include salaries and benefits for the personnel involved in the
Company’s preclinical and clinical drug development activities;
facilities expense, depreciation and other allocated expenses; and
equipment and laboratory supplies.
Costs
incurred for the rights to use licensed technologies in the
research and development process, including licensing fees and
milestone payments, are charged to research and development expense
as incurred in situations where the Company has not identified an
alternative future use for the acquired rights, and are capitalized
in situations where there is an identified alternative future use.
No cost associated with the use of licensed technologies has been
capitalized to date.
Stock-Based Compensation Expense
Stock-based compensation expense is estimated at the grant date
based on the fair value of the award, and the cost is recognized as
expense ratably over the vesting period with forfeitures accounted
for as they occur. The Company uses the Black-Scholes Merton option
pricing model for estimating the grant date fair value of stock
options using the following assumptions:
|
·
|
Volatility - Stock
price volatility is estimated over the expected term based on a
blended rate of industry peers and the Company’s actual stock
volatility adjusted for periods in which significant financial
variability was identified.
|
|
·
|
Expected term - The
expected term is based on a simplified method which defines the
life as the weighted average of the contractual term of the options
and the vesting period for each award.
|
|
·
|
Risk-free rate - The
risk-free interest rate for the expected term of the option is
based on the average market rate on U.S. Treasury securities in
effect during the period in which the awards were granted.
|
|
·
|
Dividends - The
dividend yield assumption is based on the Company’s history and
expectation of paying no dividends in the foreseeable future.
|
Net Income (Loss) Per Share of Common
Stock
The
Company applies FASB ASC No. 260, Earnings per Share in
calculating its basic and diluted net income (loss) per share.
Basic net income (loss) per share of common stock is computed by
dividing net income (loss) available to common stockholders by the
weighted-average number of shares of common stock outstanding for
the period. The diluted net loss per share of common stock is
computed by giving effect to all potential common stock equivalents
outstanding for the period determined using the treasury stock
method. For purposes of this calculation, options to purchase
common stock, restricted stock subject to vesting, warrants to
purchase common stock and common shares underlying convertible debt
instruments are considered to be common stock equivalents. The
following outstanding shares of common stock equivalents were
excluded from the computation of diluted net loss per share of
common stock for the periods presented because including them would
have been anti-dilutive:
|
|
Three Months
Ended
March
31,
|
|
|
|
2020
|
|
|
2019
|
|
Stock options
|
|
|
4,512,715 |
|
|
|
3,600,073 |
|
Unvested restricted
stock
|
|
|
643,501 |
|
|
|
1,093,501 |
|
Common shares
underlying convertible debt
|
|
|
5,125,363 |
|
|
|
15,000,000 |
|
Warrants
|
|
|
23,593,356 |
|
|
|
58,130,750 |
|
Recent Accounting Pronouncements
In
December 2019, the FASB issued ASU No. 2019-12 Income
Taxes (Topic 740) simplifying the Accounting for Income Taxes.
The Board issued this update as part of its Simplification
Initiative to improve areas of GAAP and reduce cost and complexity
while maintaining usefulness of the financial statements. The main
provisions remove certain exceptions, including the exception to
the general methodology for calculating income taxes in an interim
period when a year-to-date loss exceeds the anticipated loss for
the year. In addition, the amendments simplify income tax
accounting in the areas such as income-based franchise taxes,
eliminating the requirements to allocate consolidated current and
deferred tax expense in certain instances and a requirement that an
entity reflects the effect of enacted changes in tax laws or rates
in the annual effective tax rate computation in the interim period
that includes the enactment date. For public companies, the
standard is effective for fiscal years beginning after December 15,
2020, and interim periods therein, with early adoption permitted.
The Company plans to adopt this ASU on the effective date of
January 1, 2021. However, it may adopt the update earlier if
circumstances arise making early adoption favorable to the Company.
The amendments in the update related to foreign subsidiaries will
be applied on a modified retrospective basis, the amendments to
franchise taxes will be applied on either a retrospective or
modified retrospective basis and all other amendments will be
applied on a prospective basis. The Company is still evaluating the
impact from adopting this standard. However, because the Company’s
deferred tax assets and liabilities are fully reserved, it does not
expect a material impact from the adoption of this standard.
Recently Adopted Accounting Standards
In
November 2018, the FASB issued ASU No. 2018-08 Collaborative
Arrangements (Topic 808) intended to improve financial
reporting around collaborative arrangements and align the current
guidance under ASC 808 with ASC 606 Revenue from Contracts with
Customers. The ASU affects all companies that enter into
collaborative arrangements. The ASU clarifies when certain
transactions between collaborative arrangement participants should
be accounted for as revenue under Topic 606 and changes certain
presentation requirements for transactions with collaborative
arrangement participants that are not directly related to sales to
third parties. The Company has adopted this ASU on the effective
date of January 1, 2020. Upon adoption, the Company utilized the
retrospective transition approach, as prescribed within this ASU,
however, the Company does not currently have any collaborative
arrangements as such, there was no impact to its Condensed
Consolidated Financial Statements from adoption.
3. Warrants and Derivative Liabilities
Warrants
There are
significant judgments and estimates inherent in the determination
of the fair value of the Company’s warrants. These judgments and
estimates include assumptions regarding the Company’s future
operating performance, the time to completing a liquidity event and
the determination of the appropriate valuation methods. If the
Company had made different assumptions, the fair value of the
warrants could have been significantly different (See Note 2).
Warrants
vested and outstanding as of March 31, 2020 are summarized as
follows:
|
|
|
|
|
|
|
|
Number
of
Warrants
|
|
|
|
Exercise
|
|
|
Term
|
|
|
Vested
and
|
|
Source
|
|
Price
|
|
|
(Years)
|
|
|
Outstanding
|
|
Pre 2015 Common Stock
Warrants
|
|
$ |
1.00 |
|
|
6-10
|
|
|
|
4,000,000 |
|
2015 Common Stock
Warrants
|
|
$ |
1.15-5.00
|
|
|
5-10
|
|
|
|
442,000 |
|
Common Stock Warrants
to Series B Stockholders
|
|
$ |
0.00 |
|
|
|
5 |
|
|
|
718,750 |
|
2016 Common Stock
Warrants to Service Providers
|
|
$ |
1.15 |
|
|
|
10 |
|
|
|
40,000 |
|
2016 Series C Common
Stock Warrants to Placement Agent
|
|
$ |
0.40 |
|
|
|
5 |
|
|
|
125,000 |
|
2017 Series D Common
Stock Warrants to Placement Agent
|
|
$ |
0.25 |
|
|
|
5 |
|
|
|
480,000 |
|
2017 Common Stock
Warrants to Service Provider
|
|
$ |
0.41 |
|
|
|
5 |
|
|
|
125,000 |
|
2018 Emerald Financing
Warrants
|
|
$ |
0.10 |
|
|
|
5 |
|
|
|
3,400,000 |
|
Emerald Multi-Draw
Credit Agreement Warrants
|
|
$ |
0.50 |
|
|
|
5 |
|
|
|
7,500,000 |
|
2019 Common Stock
Warrants
|
|
$ |
0.35 |
|
|
|
5 |
|
|
|
8,000,000 |
|
Total warrants
vested and outstanding as of March 31,
2020
|
|
|
|
|
|
|
|
|
|
|
24,830,750 |
|
Emerald Multi-Draw Credit Agreement Warrants
During
the three months ended March 31, 2019, the Company issued 5,000,000
fully vested common stock warrants to Emerald Health Sciences, in
conjunction with advances under the Credit Agreement discussed
below (See Note 4). The warrants are equity classified at issuance
and the Company allocated an aggregate of $716,110 of the gross
proceeds to the warrants on a relative fair value basis. The
proceeds allocated to the warrants were recorded as discounts to
each advance and are being amortized over the term of the debt. The
warrants vested immediately and had an estimated aggregate fair
value of $1,830,573 utilizing the Black-Scholes Merton option
pricing model with the following assumptions:
|
|
At
Issuance
|
|
Dividend yield
|
|
|
0.00 |
% |
Volatility factor
|
|
91.6-92.1
|
%
|
Risk-free interest
rate
|
|
2.23-2.51
|
%
|
Expected term
(years)
|
|
|
5.0 |
|
Underlying common stock
price
|
|
$ |
0.33-0.69
|
|
Derivative Liabilities
The
following tables summarize the activity of derivative liabilities
for the periods indicated:
|
|
Three Months
Ended March 31, 2020
|
|
|
|
December 31,
2019, Fair Value of Derivative
Liabilities
|
|
|
Fair Value of
Derivative Liabilities Issued
|
|
|
Change
in
Fair value
of
Liabilities
|
|
|
Reclassification of Derivatives
to Equity
|
|
|
March 31, 2020,
Fair Value of Derivative
Liabilities
|
|
Emerald Multi-Draw
Credit Agreement - compound derivative liability (1)
|
|
$ |
90,797 |
|
|
$ |
- |
|
|
$ |
100,085 |
|
|
$ |
- |
|
|
$ |
190,882 |
|
Emerald Financing - warrant liability
(2)
|
|
|
276,024 |
|
|
|
- |
|
|
|
(81,879 |
) |
|
|
- |
|
|
|
194,145 |
|
Series B - warrant
liability (3)
|
|
|
134,579 |
|
|
|
- |
|
|
|
(54,109 |
) |
|
|
(26,563 |
) |
|
|
53,907 |
|
Total
derivative liabilities
|
|
$ |
501,400 |
|
|
$ |
- |
|
|
$ |
(35,903 |
) |
|
$ |
(26,563 |
) |
|
$ |
438,934 |
|
Less, noncurrent
portion of derivative liabilities
|
|
|
(90,797 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(190,882 |
) |
Current balance of derivative
liabilities
|
|
$ |
410,603 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
248,052 |
|
|
|
Three Months
Ended March 31, 2019
|
|
|
|
December 31,
2018, Fair Value of Derivative Liabilities
|
|
|
Fair Value of
Derivative Liabilities Issued
|
|
|
Change
in
Fair value of
Derivative Liabilities
|
|
|
Reclassification of Derivatives
to Equity
|
|
|
March 31, 2019,
Fair Value of Derivative Liabilities
|
|
Emerald Multi-Draw
Credit Agreement - compound derivative liability (1)
|
|
$ |
219,453 |
|
|
$ |
516,058 |
|
|
$ |
227,858 |
|
|
$ |
- |
|
|
$ |
963,369 |
|
Emerald Financing -
warrant liability (2)
|
|
|
15,251,413 |
|
|
|
- |
|
|
|
12,239,322 |
|
|
|
- |
|
|
|
27,490,735 |
|
Series B - warrant
liability (3)
|
|
|
487,500 |
|
|
|
- |
|
|
|
353,438 |
|
|
|
- |
|
|
|
840,938 |
|
Total
derivative liabilities
|
|
$ |
15,958,366 |
|
|
$ |
516,058 |
|
|
$ |
12,820,618 |
|
|
$ |
- |
|
|
$ |
29,295,042 |
|
Less, noncurrent
portion of derivative liabilities
|
|
|
(219,453 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(963,369 |
) |
Current balance
of derivative liabilities
|
|
$ |
15,738,913 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
28,331,673 |
|
Emerald Multi-Draw Credit Agreement Compound Derivative
Liability (1)
In
connection with the advances under the Credit Agreement (See Note
4), the Company bifurcated a compound derivative liability related
to a contingent interest feature and acceleration upon default
provision (contingent put option) provided to Emerald Health
Sciences. The Company’s estimate of fair value of the compound
derivative liability was determined by using a differential cash
flows valuation model, wherein the fair value of the underlying
debt facility and its conversion right are estimated both with and
without the presence of the contingent interest feature, holding
all other assumptions constant. The resulting difference between
the estimated fair values in both scenarios is the estimated fair
value of the compound derivative. The fair value of the underlying
debt facility is estimated by calculating the expected cash flows
with consideration of the estimated probability of a change in
control transaction, defined as an event of default by the
agreement, and applying the expected default interest rate from the
date of such default through maturity. The expected cash flows are
then discounted back to the reporting date using a benchmark market
yield. The conversion right component of the compound derivative is
measured using a standard Black-Scholes model for each payment
period. Because Emerald Health Sciences would forgo the contingent
interest if the contingent put option was exercised upon an event
of default, the value ascribed to the contingent put option within
the compound derivative is de minimis.
In
determining the fair value of the debt and contingent interest
feature the Company used the following assumptions at the balance
sheet date:
|
|
March
31,
2020
|
|
Volatility factor
|
|
|
79.8 |
% |
Benchmarked yield
|
|
|
18.46 |
% |
Remaining term
(years)
|
|
|
2.55 |
|
Underlying common stock
price
|
|
$ |
0.08 |
|
Emerald Financing Warrant Liability (2)
In
January and February 2018, the Company issued 44,200,000 warrants
to purchase common stock in conjunction with the Emerald Financing.
The warrants vest immediately and have an exercise price of $0.10
per share with a term of five years and are exercisable in cash or
through a cashless exercise provision. The warrants contain an
anti-dilution protection feature provided to the investors if the
Company subsequently issues or sells any shares of common stock,
stock options, or convertible securities at a price less than the
exercise price of $0.10. The exercise price is automatically
adjusted down to the price of the instrument being issued. In
addition, the warrants contain a contingent put option if the
Company undergoes a subsequent financing that results in a change
in control. The warrant holders also have the right to participate
in subsequent financing transactions on an as-if converted
basis.
In
December 2019, Emerald Health Sciences paid the aggregate exercise
price of $4,080,000 in the form of a reduction of the corresponding
amount of obligations outstanding under the Credit Agreement to
exercise 40,800,000 Emerald Financing Warrants. Under the Warrant
Exercise Agreement between the Company and Emerald Health Sciences,
the proceeds from the warrants were first applied directly to the
accrued interest balance at the exercise date with the remainder
applied to the oldest outstanding principal balances under the
Credit Agreement. Immediately prior to exercise, the warrants were
adjusted to fair value which considered the closing trading price
on the exercise date (See Note 4).
The
Company reviewed the warrants for liability or equity
classification under the guidance of ASC 480-10, Distinguishing
Liabilities from Equity, and concluded that the warrants
should be classified as a liability and re-measured to fair value
at the end of each reporting period. The Company also reviewed the
warrants under ASC 815, Derivatives and Hedging/Contracts in
Entity’s Own Equity, and determined that the warrants also
meet the definition of a derivative. With the assistance of a
third-party valuation specialist, the Company valued the warrant
liabilities utilizing the Monte Carlo valuation method pursuant to
the accounting guidance of ASC 820-10, Fair Value
Measurements.
The
warrant liabilities were valued using Monte Carlo simulations
conducted at the balance sheet dates using the following
assumptions:
|
|
March
31,
2020
|
|
|
December
31,
2019
|
|
Dividend yield
|
|
|
0.00 |
% |
|
|
0.00 |
% |
Volatility factor
|
|
|
81.4 |
% |
|
|
79.5 |
% |
Risk-free interest
rate
|
|
|
0.28 |
% |
|
|
1.62 |
% |
Expected term
(years)
|
|
|
2.88 |
|
|
|
3.13 |
|
Underlying common stock
price
|
|
$ |
0.08 |
|
|
$ |
0.13 |
|
Series B Warrant Liability (3)
In
conjunction with the Redeemable Convertible Series B Preferred
Stock financing, the Company issued the 2015 Series B Financing
Warrants originally exercisable at a price of $1.15 per share. The
warrants are exercisable in cash or through a cashless exercise
provision and contain certain cash redemption rights. The Series B
warrants also had a “down-round” protection feature if the Company
subsequently issued or sold any shares of common stock, stock
options, or convertible securities at a price less than the current
exercise price. The down round provision was triggered and
automatically adjusted down to $0.10 on December 28, 2017, after
the Company entered into the Convertible Promissory Note (See Note
4) and again to $0.00 on January 19, 2018, as a result of the
Emerald Financing. The strike price for these warrants is now
permanently reset. However, because the remaining warrant holders
still have certain cash redemption rights upon the occurrence of
certain fundamental transactions, as defined in the Series B
warrant agreements, the warrants continue to require liability
classification. Subsequent to the repricing that occurred as a
result of the Emerald Financing, the warrants have been valued
using a Black Scholes Merton Option Pricing Model.
To
compute the fair value of the warrants, the Company utilized the
following assumptions in the Black Scholes Merton Option Pricing
Model for the periods indicated:
|
|
As
of
March
31,
2020
|
|
|
As
of
December
31,
2019
|
|
Dividend yield
|
|
|
0.00 |
% |
|
|
0.00 |
% |
Volatility factor
|
|
|
79.8 |
% |
|
|
79.2 |
% |
Risk-free interest
rate
|
|
|
0.13 |
% |
|
|
1.60 |
% |
Expected term
(years)
|
|
|
0.39 |
|
|
|
0.64 |
|
Underlying common stock
price
|
|
$ |
0.08 |
|
|
$ |
0.13 |
|
During
the three months ended March 31, 2020, 312,500 Series B Common
Stock Warrants with an intrinsic value of $26,563 were exercised
for no consideration per share, which resulted in the issuance of
312,500 shares of common stock. Prior to exercise, these Series B
Warrants were adjusted to fair value using a Black Scholes Merton
Option Pricing Model which considered the closing trading price on
the exercise dates. Because the exercise price of these options had
been reset to $0.00, the fair value derived from the valuation
model approximated the market value of the Company’s common stock
on the exercise dates.
4. Convertible Debt - Related Party
The
Company’s Convertible Debt with Emerald Health Sciences consists of
the following:
|
|
As
of
March
31,
2020
|
|
|
As
of
December
31,
2019
|
|
Total principal
value
|
|
$ |
2,014,500 |
|
|
$ |
2,014,500 |
|
Unamortized debt
discount
|
|
|
(1,491,997 |
) |
|
|
(1,622,344 |
) |
Unamortized debt
issuance costs
|
|
|
(4,723 |
) |
|
|
(5,086 |
) |
Carrying value
of total convertible debt - related party
|
|
$ |
517,780 |
|
|
$ |
387,070 |
|
Less, noncurrent
portion
|
|
|
(517,780 |
) |
|
|
(387,070 |
) |
Current
convertible debt - related party
|
|
$ |
- |
|
|
$ |
- |
|
The
Company’s interest expense consists of the following:
|
|
Three Months
Ended
March
31,
|
|
|
|
2020
|
|
|
2019
|
|
Interest expense -
stated rate
|
|
$ |
35,645 |
|
|
$ |
59,111 |
|
Non-cash interest
expense:
|
|
|
|
|
|
|
|
|
Amortization of debt discount
|
|
|
130,347 |
|
|
|
53,979 |
|
Amortization of transaction costs
|
|
|
363 |
|
|
|
2,973 |
|
|
|
$ |
166,355 |
|
|
$ |
116,063 |
|
Multi-Draw Credit Agreement
On
October 5, 2018, the Company entered into the Credit Agreement with
Emerald Health Sciences, a related party (See Note 7). The Credit
Agreement provides for a credit facility to the Company of up to
$20,000,000 and is unsecured. Advances under the Credit Agreement
bear interest at an annual rate of 7% (payable quarterly in
arrears) and mature on October 5, 2022. At Emerald Health Sciences’
election, advances and unpaid interest may be converted into common
stock at a fixed conversion price of $0.40, subject to customary
adjustments for stock splits, stock dividends, recapitalizations,
etc. As of March 31, 2020, the unused portion of the credit
facility is $14,000,000. The drawdowns are subject to approval by
the Company’s Board, which is controlled by the directors of
Emerald Health Sciences. As such, we do not consider the facility
available until advance requests are approved, drawn down and
funded. The Credit Agreement is still in place, however, there is
no guarantee of continued funding.
The
Credit Agreement provides for customary events of default which may
result in the acceleration of the maturity of the advances in
addition to, but not limited to, cross acceleration to certain
other indebtedness of the Company or a change in control. In the
case of an event of default arising from specified events of
bankruptcy or insolvency or reorganization, all outstanding
advances will become due and payable immediately without further
action or notice. If any other event of default under the Credit
Agreement occurs or is continuing, Emerald Health Sciences may, by
written notice, terminate its commitment to make any advances
and/or declare all the advances with any other amounts payable due
immediately. If any amount under the Credit Agreement is not paid
when due, such overdue amount shall bear interest at an annual
default interest rate of the applicable rate plus 10%, until such
amount is paid in full.
In
connection with each advance under the Credit Agreement, the
Company agreed to issue to Emerald Health Sciences warrants to
purchase shares of common stock in an amount equal to 50% of the
number of shares of common stock that each advance may be converted
into. The warrants have an exercise price of $0.50 per share, a
term of five years and are immediately exercisable upon issuance.
The exercise price is subject to adjustment in the event of certain
stock dividends and distributions, stock splits, stock
combinations, reclassifications or similar events or upon any
distributions of assets, including cash, stock or other property to
the Company’s stockholders (See Note 3).
In
accounting for each convertible advance and the warrants issued
under the Credit Agreement, the Company allocates the proceeds
between the debt host and the freestanding warrants on a relative
fair value basis for each advance. On the date of each advance, if
the effective conversion rate of the debt is less than the market
value of the Company’s common stock, the Company records a
beneficial conversion feature as a discount to the debt and an
increase to additional paid-in capital. The debt discounts related
to the warrants, beneficial conversion features and compound
derivatives, if any, are being amortized over the term of the
Credit Agreement using the effective interest rate method.
Amortization of the debt discount is recognized as non-cash
interest expense and the compound derivatives related to the
contingent interest feature and acceleration upon default provision
are remeasured at fair value in subsequent periods in the Company’s
Condensed Consolidated Balance Sheets.
On
November 1, 2018, the initial advance under Credit Agreement was
made for $2,000,000 and the Company issued 2,500,000 warrants (See
Note 3). In accounting for the convertible advances and warrants
under the Credit Agreement, $1,684,920 of the proceeds was
allocated to the debt and $315,080 was allocated to equity
classified warrants. A beneficial conversion feature of $90,080 and
a compound derivative liability of $204,102 were also recorded.
During
the three months ended March 31, 2019, the Company initiated two
advances under Credit Agreement, each in the amount of $2,000,000,
for an aggregate principal amount of $4,000,000, and the Company
issued an aggregate of 5,000,000 warrants to Emerald Health
Sciences (See Note 3). In accounting for the convertible advances
and warrants issued under the Credit Agreement, an aggregate amount
of $3,283,890 was allocated to the debt and $716,110 was allocated
to equity classified warrants. A beneficial conversion feature of
$1,584,850 and compound derivative liabilities of an aggregate of
$516,058 have been recorded (See Note 3). Of the $516,058 in
compound derivatives, $322,644 was recorded as other expense in the
Condensed Consolidated Statements of Comprehensive Loss for the
three months ended March 31, 2019, as the value of the beneficial
conversion feature exceeded the proceeds allocated to the third
draw.
Aggregate financing costs of $63,007 incurred in connection with
the Credit Agreement have been recorded as a discount to the debt
host and are being amortized using the effective interest rate
method and recognized as non-cash interest expense over the term of
the Credit Agreement.
During
the year ended December 31, 2019, the Company used $3,985,500 in
proceeds from the exercise of the 2018 Emerald Financing Warrants
to prepay a portion of the principal balance on the Credit
Agreement. In connection with the prepayment, the Company recorded
an extinguishment loss of $725,425 in the fourth quarter of 2019.
The extinguishment loss was calculated as the difference between
the fair value of the consideration paid to extinguish the debt and
carrying value of the debt host plus the related compound
derivative liability.
As of
March 31, 2020, the unamortized debt discount will be amortized
over a remaining period of approximately 2.52 years. The fair value
of the underlying shares of the convertible multi draw credit
agreement was $377,719 at March 31, 2020. As of March 31, 2020, the
if-converted value did not exceed the principal balance.
5. Stock-Based Compensation
Stock Incentive Plan
On
October 31, 2014, after the closing of the Merger, the Board
approved the Company’s 2014 Omnibus Incentive Plan (the “2014
Plan”). The 2014 Plan initially reserved 3,200,000 shares for
future grants. In October 2018, the Company increased the share
reserve under the 2014 Plan to equal 10% of the number of issued
and outstanding shares of common stock of the Company. The 2014
Plan authorizes the issuance of awards including stock options,
stock appreciation rights, restricted stock, stock units and
performance units to employees, directors, and consultants of the
Company. As of March 31, 2020, the Company had 13,159,631 shares
available for future grant under the 2014 Plan.
Stock Options
There was no option
activity under the Company’s 2014 Plan during the three months
ended March 31, 2020.
Restricted Stock Awards
There
was no restricted stock award (“RSA”) activity under the Company’s
2014 Plan during the three months ended March 31, 2020.
Awards Granted Outside the 2014 Plan
Options
There
was no option activity outside of the 2014 Plan during the three
months ended March 31, 2020.
Restricted Stock Awards
The
following is a summary of RSA activity outside of the Company’s
2014 Plan during the three months ended March 31, 2020:
|
|
Number
of
Shares
|
|
|
Weighted
Average
Grant
Date Fair
Value
|
|
Unvested,
December 31, 2019
|
|
|
450,000 |
|
|
$ |
0.19 |
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
- |
|
|
|
- |
|
Released
|
|
|
(450,000 |
) |
|
|
0.19 |
|
Unvested, March
31, 2020
|
|
|
- |
|
|
$ |
- |
|
Stock-Based Compensation Expense
The Company recognizes
compensation expense using the straight-line method over the
requisite service period. For the three months ended March 31, 2020
and 2019, the Company recognized stock-based compensation expense
of $64,142 and $171,493, respectively (including compensation
expense for RSAs discussed above), which was recorded as a general
and administrative expense in the Condensed Consolidated Statements
of Comprehensive Loss. The total amount of unrecognized
compensation cost was $248,264 as of March 31, 2020. This amount
will be recognized over a weighted average period of 1.74
years.
6. Significant Contracts - University of
Mississippi
UM 5050 Pro-Drug and UM 8930 Analog
Agreements
In July 2018, the
Company renewed its ocular licenses for UM 5050, related to the
pro-drug formulation of tetrahydrocannabinol (“THC”), and UM 8930,
related to an analog formulation of cannabidiol (“CBD”). On May 24,
2019, the ocular delivery licenses were replaced by “all fields of
use” licenses for both UM 5050 and UM 8930 (collectively, the
“License Agreements”). Pursuant to the License Agreements, UM
granted the Company an exclusive, perpetual license, including,
with the prior written consent of UM, the right to sublicense, to
intellectual property related to UM 5050 and UM 8930 for all fields
of use.
The License Agreements
contain certain milestone payments, royalty and sublicensing fees
payable by the Company, as defined therein. Each License Agreement
provides for an annual maintenance fee of $75,000 payable on the
anniversary of the effective date. The upfront payment for UM 5050
is $100,000 and the upfront payment for UM 8930 is $200,000. In
addition, in March 2020, the Company was notified by the United
States Patent and Trademark Office, that a notice of allowance was
issued for the proprietary analog of cannabidiol, CBDVHS, under the
UM 8930 License Agreement. As a result, the Company was required to
pay UM a fee of $200,000. The milestone payments payable for each
license are as follows:
i)
|
$100,000 paid within 30
days following the submission of the first Investigational New Drug
Application to the Food and Drug Administration or an equivalent
application to a regulatory agency anywhere in the world, for a
product;
|
|
|
ii)
|
$200,000 paid within 30
days following the first submission of an NDA, or an equivalent
application to a regulatory agency anywhere in the world, for each
product that is administered in a different route of administration
from that of the early submitted product(s); and
|
|
|
iii)
|
$400,000 paid within 30
days following the approval of an NDA, or an equivalent application
to a regulatory agency anywhere in the world, for each product that
is administered in a different route of administration from that of
the early approved product(s).
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The
royalty percentage due on net sales under each License Agreement is
in the mid-single digits. The Company must also pay to UM a portion
of all licensing fees received from any sublicensees, subject to a
minimum royalty on net sales, and the Company is required to
reimburse patent costs incurred by UM related to the licensed
products. The royalty obligations apply by country and by licensed
product, and end upon the later of the date that no valid claim of
a licensed patent covers a licensed product in a given country, or
ten years after the first commercial sale of such licensed product
in such country.
Each
License Agreement continues, unless terminated, until the later of
the expiration of the last to expire of the patents or patent
applications within the licensed technology or the expiration of
the Company’s payment obligations under such License Agreement. UM
may terminate each License Agreement, by giving written notice of
termination, upon the Company’s material breach of such License
Agreement, including failure to make payments or satisfy covenants,
representations or warranties without cure, noncompliance, a
bankruptcy event, the Company’s dissolution or cessation of
operations, the Company’s failure to make reasonable efforts to
commercialize at least one product or failure to keep at least one
product on the market after the first commercial sale for a
continuous period of one year, other than for reasons outside the
Company’s control, or the Company’s failure to meet certain
pre-established development milestones. The Company may terminate
each License Agreement upon 60 days’ written notice to UM.
As of
March 31, 2020, with the exception of the fee due for the notice of
allowance for CBDVHS, none of the other milestones under these
license agreements have been met.
UM 5070 License Agreement
In
January 2017, the Company entered into a license agreement with UM
pursuant to which UM granted us an exclusive, perpetual license,
including the right to sublicense, to intellectual property related
to a platform of cannabinoid-based molecules (“UM 5070”), to
research, develop and commercialize products for the treatment of
infectious diseases. The license agreement culminates roughly one
year of screening and target molecule identification studies
especially focused on therapy-resistant infectious organisms like
Methicillin-resistant Staphylococcus aureus (“MRSA”).
The
Company paid UM an upfront license fee under the license agreement.
Under the license agreement, the Company is also responsible for
annual maintenance fees that will be credited against royalties in
the current fiscal year, contingent milestone payments upon
achievement of development and regulatory milestones, and royalties
on net sales of licensed products sold for commercial use. The
aggregate milestone payments due under the license agreement if all
the milestones are achieved is $700,000 and the royalty percentage
due on net sales is in the mid-single digits. The Company must also
pay to UM a percentage of all licensing fees we receive from any
sublicensees, subject to a minimum royalty on net sales by such
sublicensees. The Company’s royalty obligations apply on a country
by country and licensed product by licensed product basis, and end
upon the later of the date that no valid claim of a licensed patent
covers a licensed product in a given country, or ten years after
first commercial sale of such licensed product in such country.
The
license agreement continues, unless terminated, until the later of
the expiration of the last to expire of the patents or patent
applications within the licensed technology or expiration of the
Company’s payment obligations under the license. UM may terminate
the license agreement, effective with the giving of notice, if: (a)
the Company fails to pay any material amount payable to UM under
the license agreement and do not cure such failure within 60 days
after UM notifies us of such failure, (b) the Company materially
breaches any covenant, representation or warranty in the license
agreement and do not cure such breach within 60 days after UM
notifies the Company of such breach, (c) the Company fails to
comply in any material respect with the terms of the license and do
not cure such noncompliance within 60 days after UM notifies us of
such failure, (d) the Company is subject to a bankruptcy event, (e)
the Company dissolves or ceases operations or (f) if after the
first commercial sale of a product during the term of the license
agreement, the Company materially fails to make reasonable efforts
to commercialize at least one product or fail to keep at least one
product on the market after the first commercial sale for a
continuous period of one year, other than for reasons outside of
the Company’s control. The Company may terminate the license
agreement upon 60 days’ written notice to UM.
As of
March 31, 2020, none of the milestones under this license agreement
have been met.
7. Related Party Matters
Emerald Health Sciences
On
February 1, 2018, the Company entered into an Independent
Contractor Agreement with Emerald Health Sciences, pursuant to
which Emerald Health Sciences agreed to provide such services as
are mutually agreed between the Company and Emerald Health
Sciences, including reimbursement for reasonable expenses incurred
in the performance of the Independent Contractor Agreement. These
services included, but were not limited to, corporate advisory
services and technical expertise in the areas of business
development, marketing, investor relations, information technology
and product development. The Independent Contractor Agreement had
an initial term of 10 years and specified compensation which was
agreed upon between the Company’s Chief Executive Officer and
Emerald Health Sciences’ Chairman, CEO and President on a
month-to-month basis. The fee due under this agreement was payable
on a monthly basis. Effective December 31, 2019, the Independent
Contractor Agreement was terminated. As of March 31, 2020, the
Company maintains an accrual of $7,032 in expenses under the
Independent Contractor Agreement which have yet to be paid. Under
this agreement, no expenses were incurred for the three months
ended March 31, 2020. For the three months ended March 31, 2019,
the Company incurred expenses of $150,000.
On
December 17, 2019, Dr. Avtar Dhillon resigned as the Chairman of
the Board and the position of Chairman of the Finance and Business
Development Committee of the Board. Concurrently, the Company
entered into a Board Observer Agreement with Emerald Health
Sciences to allow Dr. Dhillon to continue as a representative of
Emerald Health Sciences as a non-voting observer in future meetings
of the Board.
On December 19, 2019,
the Company entered into an Independent Contractor Services
Agreement with Dr. Avtar Dhillon, pursuant to which Dr. Dhillon
will provide ongoing corporate finance and strategic business
advisory services to the Company. In exchange for his services, Dr.
Dhillon will receive a monthly fee of $10,000, with (i) $5,000 paid
each month and (ii) $5,000 accruing from the effective date and
payable upon the Company’s completion of a material financing. The
Board will review the monthly rate paid to Dr. Dhillon within 90
days of the end of each fiscal year. The Independent Contractor
Services Agreement has an initial term of one year and will renew
automatically thereafter unless terminated earlier by either party.
The Independent Contractor Services Agreement may be terminated by
either party for cause upon written notice to the other party if
the other party defaults in the performance of the agreement in any
material respect or materially breaches the terms of the agreement,
or without cause upon 30 days’ prior written notice to the other
party. On March 30, 2020, the Company and Dr. Dhillon amended the
Independent Contractor Services Agreement by agreeing to accrue
100% of Dr. Dhillon’s consulting fees until the Board of Directors
determines that the Company has been sufficiently financed to make
such payments at which point the Company agrees to pay Dr. Dhillon
all of his accrued consulting fees, and a bonus of 10% of his
accrued consulting fees, less applicable tax and other
withholdings. As of March 31, 2020, the Company has accrued $33,871
in expense related to the Independent Contractor Services
Agreement.
8. Subsequent Events
Amended and Restated Multi-Draw Credit
Agreement
On April
29, 2020, the Company entered into an Amended and Restated
Multi-Draw Credit Agreement with Emerald Health Sciences, which
amends and restates the Credit Agreement, dated October 5, 2018.
The Amended Credit Agreement provides for a credit facility in the
principal amount of up to $20,000,000, which includes, without
limitation, the advances totaling $6,000,000 that were granted
prior to the amendment and advances of at least $150,000 for each
of May, June and July 2020.
In connection with each
advance under the Amended Credit Agreement, the Company shall,
absent the Lender’s notice not to issue any warrant, continue to
issue to Emerald Health Sciences, a warrant to purchase up to the
number of shares of the Common Stock of the Company equal to the
dollar amount of such advance divided by 0.50. However, warrants
issued under the Amended Credit Agreement will have an exercise
price of $0.35 per share of Common Stock. Warrants issued prior to
the date of the Amended Credit Agreement shall not be modified,
amended or altered by the terms of the Amended Credit Agreement and
shall remain in full force and effect.
Emerald Health Science
will, in its sole discretion, at the time of an advance, determine
as to whether such advance will or will not be convertible into
shares of Common Stock in the future. Advances under the Amended
Credit Agreement are convertible into shares of Common Stock at a
reduced fixed conversion price of $0.25 per share of Common Stock.
However, the conversion price of all advances outstanding under the
Credit Agreement as of the date of the Amended Credit Agreement
shall be deemed convertible by the Lender at a conversion price of
$0.40 per share of Common Stock as set forth in the Existing Credit
Agreement.
Pursuant to the Amended
Credit Agreement, the Company and the Lender have agreed to
terminate that certain Registration Rights Agreement, dated as of
October 5, 2018, by and between the Company and the Lender, and the
Lender has agreed to defer all interest accrued and/or due under
the Amended Credit Agreement, beginning the quarter ended June 30,
2020, until the Company completes a capital raise of at least
$5,000,000. All other material terms of the Credit Agreement,
including, without limitation, the maturity date and interest rate,
remain the same in the Amended Credit Agreement.
Immediately upon entering into the Amended Credit Agreement, the
Company effected a fourth advance in the amount of $150,000. The
advance bears an interest at 7% per annum and matures on October 5,
2022. The Company intends to use the net proceeds of the advance
for general corporate and working capital purposes. The Lender has
elected that the fourth advance will not be convertible into shares
of Common Stock and gave notice to the Company that no warrant will
be issued in connection with the advance at this time.
Paycheck Protection Program Promissory
Note
On April 22, 2020, the
Company entered into a PPP Note in the principal amount of $116,700
from the PPP Loan Lender. The PPP Loan was obtained pursuant to the
PPP of the CARES Act administered by the SBA.
The PPP
Loan was disbursed by the PPP Loan Lender to the Company on April
24, 2020 and will mature two years from the Disbursement Date. The
PPP Loan bears an interest at 1.00% per annum and is payable
monthly commencing seven months from the Disbursement Date. The PPP
Loan may be prepaid at any time prior to maturity with no
prepayment penalties. Funds from the PPP Loan may only be used by
the Company for payroll costs, costs for continuing group
healthcare benefits, mortgage interest payments, rent, utility and
interest on any other debt obligations that were incurred before
February 15, 2020.
All or a portion of
principal of the PPP Loan may be forgiven by the SBA and the PPP
Loan Lender upon application by the Company within 60 days but not
later than 120 days after loan approval and upon documentation of
expenditures in accordance with the SBA requirements. Under the
CARES Act, loan forgiveness is available for the sum of documented
payroll costs, covered rent payments, and covered utilities during
the eight-week period commencing on the date of loan approval. For
purposes of the CARES Act, payroll costs exclude compensation of an
individual employee in excess of $100,000, prorated annually. Not
more than 25% of the forgiveness amount may be for non-payroll
costs. Forgiveness is reduced if full-time headcount declines, or
if salaries and wages of employees with salaries of $100,000 or
less annually are reduced by more than 25%. After approval of the
forgiveness amount and six month deferral period, the PPP Loan
Lender will provide the Company with written notification of
re-amortization of the PPP Loan and the remaining balance.
Separation of Chief Financial
Officer
On April
29, 2020, the Company entered into a separation and release
agreement (the “Separation Agreement”) with Douglas Cesario, Chief
Financial Officer. Mr. Cesario’s separation will be effective May
15, 2020 (the “Separation Date”), and he will remain the Company’s
principal financial officer until the Separation Date.
Pursuant
to the Separation Agreement, Mr. Cesario has agreed to certain
ongoing cooperation obligations and to provide certain releases and
waivers as contained in the Separation Agreement. As consideration
under the Separation Agreement, the Company has agreed to provide
Mr. Cesario compensation and benefits as follows: (i) through the
Separation Date, an annualized base salary at the rate in effect
for him as of the date of the Separation Agreement; (ii) a gross
payment of $125,000 in consideration for the restrictive covenants
contained in the Separation Agreement; and (iii) a continuation of
health insurance benefits for a period of six months following the
Separation Date.
In
connection with the termination of the Company’s Chief Financial
Officer 325,929 unvested stock options will be cancelled on May 15,
2020.
Item
2. Management’s Discussion and Analysis of Financial Condition and
Results of Operations.
The
following discussion and analysis of our financial condition and
results of operations should be read in conjunction with our
financial statements for the three months ended March 31, 2020 and
2019 (unaudited) and the year ended December 31, 2019 together with
the notes thereto. In addition to historical information, this
discussion and analysis contains forward-looking statements that
involve risks, uncertainties and assumptions. Our actual results
may differ materially from those anticipated in these
forward-looking statements as a result of certain factors,
including, but not limited, to those set forth under “Risk Factors”
and elsewhere in this Quarterly Report on Form 10-Q.
Unless otherwise
provided in this Quarterly Report, references to “we,” “us,” “our,”
”the Company,” and “Emerald Bioscience” in this discussion and
analysis refer to Emerald Bioscience, Inc., a Nevada corporation
formerly known as Nemus Bioscience, Inc. and Load Guard Logistics,
Inc., together with its wholly-owned subsidiaries, Nemus, a
California corporation, and EMBI Australia Pty Ltd., an Australian
proprietary limited company.
Overview
We are a
biopharmaceutical company targeting the discovery, development, and
commercialization of cannabinoid-based therapeutics, through a
number of license agreements with the University of Mississippi
(“UM”). UM holds the only contract to cultivate cannabis for
research purposes on behalf of the Federal Government of the United
States and has held that federal license since 1968, and it has
significant expertise in cannabis cultivation and the extraction,
separation, processing and manufacture of cannabis extracts as well
as the chemistry and physiology of cannabinoid molecules. We strive
to serve as UM’s partner for the development and commercialization
of cannabinoid-based therapeutics, and the realization of this
partnership will depend on the successful development of these
compounds through the regulatory requirements of drug approval
agencies, like the Food and Drug Administration (the “FDA”) in the
United States and the European Medicines Agency in the European
Union.
Effective March 25, 2019, we changed our name from Nemus
Bioscience, Inc. to Emerald Bioscience, Inc.
In
August 2019, we formed a new subsidiary in Australia, EMBI
Australia Pty Ltd, in order to qualify for the Australian
government’s research and development tax credit for research and
development dollars spent in Australia. The primary purpose of EMBI
Australia is to conduct clinical trials for our product
candidates.
Recent Events and Significant Contracts.
Expansion of UM
5050 and UM 8930 Licenses from Ocular Delivery Only to All Fields
of Use
On May 24, 2019, we
executed two restated and amended license agreements with UM which
expanded our use of UM 5050, a pro-drug of tetrahydrocannabinol
(“THC”), and UM 8930, an analog of cannabidiol (“CBD”), from ocular
delivery only to all fields of use. Pursuant to these license
agreements, we have exclusive, perpetual, worldwide licenses
related to UM 5050 and UM 8930. Additionally, with the prior
written consent of UM, we have the right to sublicense the licensed
intellectual property.
The all fields use for
tetrahydrocannabinol-valine-hemisuccinate (“THCVHS”), the
proprietary prodrug of THC, is expected to allow us to explore
related uses for the active moiety of the prodrug, namely THC.
Independent in vitro and in vivo studies have demonstrated the
potential use of THC in a variety of potential indications based on
the ability of the cannabinoid to act as an anti-inflammatory,
anti-fibrotic, and/or inhibitor of neovascularization. The Company
has generated data related to these effects using an ex vivo human
tissue model of the eye. The prodrug technology employed in THCVHS
is designed to enhance the bioavailability and pharmacokinetic
predictability of the active part of the molecule, once introduced
into the body through routes of administration currently being
considered by the development team. Given the positive data
accumulated to date in studies of the eye, we could explore
additional central nervous system applications for THCVHS. We
expect to develop strategic collaborations to identify and advance
these applications.
The all fields use of
cannabidiol-valine-hemisuccinate (“CBDVHS”), the analog of CBD, is
expected to permit us to expand research and development into organ
systems outside of the current ocular space. Potential disease
targets over time could involve the central nervous system, the
gastrointestinal tract, the endocrine/metabolic system,
reproductive system diseases, or as yet unrecognized opportunities.
This bioengineered version of CBD is expected to enlarge the
disease target pool by virtue of new routes of administration into
the body, thereby enhancing bioavailability. The determination by
the DEA that CBDVHS is not a controlled substance permits us to
enlarge the potential pool of clinical test sites and a more
diverse patient pool in the study of disease. We expect to develop
strategic collaborations to identify and advance these
applications.
NB1111
NB1111, our lead ocular
compound, is a prodrug of THC. We have delayed our first-in-human
studies of NB1111, from the second-half of 2020, to the 2021
timeframe. The first-in-human studies are expected to be conducted
in both normal controls and patients with glaucoma or ocular
hypertension in Australia (the “Clinical Trial”). The manufacturing
of the active pharmaceutical ingredient of NB1111 is conducted in
the United States. Formulation of the eye drop for testing is also
performed in the United States but can rely on regulatory-accepted
excipients that can be sourced from countries outside the United
States, such as China. In lieu of the recent pandemic of COVID-19
there could possibly be an impact on sourcing materials that are
part of the eye drop formulation, as well as impacting volunteer
and/or patient recruitment in Australia for clinical studies.
During 2019 and the
three months ended March 31, 2020, we achieved various milestones
related to the research and development of NB1111, including the
following:
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UM completed experiments showing
that NB1111 was statistically superior in lowering intraocular
pressure (“IOP”) compared to the prostaglandin-based therapy,
latanoprost, the current standard-of-care for treating glaucoma.
Significance was reached across multiple timepoints during a
seven-day course of dosing using a validated rabbit normotensive
ocular model and NB1111 exerted pharmacologic activity consistent
with twice-daily dosing. |
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Glauconix Biosciences Inc.
(“Glauconix”) completed their pilot study to research the mechanism
of action and IOP-lowering ability of THC when administered into an
ex vivo model of a 3D-human trabecular meshwork using both healthy
and glaucomatous-derived tissues. The Glauconix study validated the
mechanism of action of NB1111 in lowering IOP, a defining disease
process of hypertensive glaucoma. Additionally, biomarkers
associated with inflammation and fibrosis in both normal and
tissues affected by glaucoma were significantly decreased, pointing
to anti-inflammatory and anti-fibrotic activities that are often
associated with the cannabinoid class of molecules in other
disease-states; and data revealed that biomarkers associated with
neovascularization, a disease process of new blood vessel formation
that can damage the retina in a variety of ocular diseases, was
also inhibited by THC, prompting further study for the utility of
this drug in diseases of the retina. |
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In August 2019, EMBI Australia Pty
Ltd entered into a start-up agreement with Novotech (Australia) Pty
Limited (“Novotech”). The start-up agreement is being entered into
in connection with the launch of the Clinical Trial. We expect to
pay approximately $45,000 in professional fees and pass through
costs in connection with the services provided for in the start-up
agreement. Additionally, on September 26, 2019, EMBI Australia Pty
Ltd and Novotech executed a Master Services Agreement and
anticipate entering into project agreements covering all
anticipated services to be provided by Novotech to us in connection
with the Clinical Trial. |
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In August 2019, EMBI Australia
entered into a master service agreement and initial statement of
work with Agilex Biolabs Pty Ltd (“Agilex”), pursuant to which
Agilex would assist with the assay set up for the anticipated
Clinical Trial. |
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In August 2019, we executed an
agreement with Bioscience Laboratories, Inc. to complete Draize
testing in advance of the anticipated Clinical Trial. |
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AMRI worked toward closing the
synthesis validation pathway to manufacture cGMP API of THCVHS with
validation of drug product purity. In turn, on April 30, 2019, we
entered into an additional agreement with AMRI related to non-GMP
synthesis of a demonstration batch of our pro-drug of THC. In
August 2019, our manufacturing agreement with AMRI for THCVHS that
was executed in July 2018 was replaced by the agreement with
Noramco discussed below. |
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On August 7, 2019, we entered into
a first amendment to our agreement with Noramco to manufacture
THCVHS (the “Noramco Agreement,” as amended from time to time).
CBDVHS was being manufactured pursuant to the Noramco Agreement
prior to the amendment. We paid $257,800 upfront to add the
manufacture of THCVHS to the Noramco Agreement and additional
payments will be made upon Noramco’s shipping of the GMP active
pharmaceutical ingredient to us. All other material terms of the
Noramco Agreement remain the same. |
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In January 2019, we engaged RRD
International, LLC (“RRD”) to provide strategic ophthalmic
505(b)(2) regulatory planning, prepare a Pre- IND meeting briefing
book, and schedule and represent us at the Pre-IND meeting with the
FDA. In May 2019, we executed a change order to extend our work
with RRD as we continue to progress toward our Pre-IND meeting. In
August 2019, we executed an additional work order with RRD to
assist us in preparing an investigator’s brochure to support the
Clinical Trial. |
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In January 2019, we executed an
agreement with Pharmaceuticals International, Inc. (“PII”) to
conduct studies to determine options for producing a sterile dosage
form which can be dosed in humans in a clinical study. PII will
conduct appropriate formulation studies to determine storage and
processing options. Pursuant to the terms of the agreement, we paid
$72,500 to initiate the project. After the initial evaluation we
have agreed to pay additional fees and expenses upon completion of
certain milestones |
NB2222
NB2222 is the ocular
formulation of our proprietary CBD analog. We have embarked on
studies with UM exploring the utility of our drug candidate NB2222
as an eye drop nanoemulsion for the potential treatment and
management of several eye diseases, including but not limited to,
uveitis, dry eye syndrome, macular degeneration and diabetic
retinopathy.
In July 2019, we
engaged Glauconix to conduct research as to whether CBD or CBDVHS
is associated with an increase in IOP and, if so, what the
potential mechanism of action would be by exposing the 3D-human
trabecular meshwork tissue constructs to these molecules. In
December 2019, we announced that data generated by Glauconix
Biosciences, Inc. showed significant anti-inflammatory and
anti-fibrotic activity in ocular tissue with CBDVHS when compared
to CBD, indicating therapeutic potential as a neuroprotectant,
especially in diseases of the retina. Additionally, CBD was
associated with biomarkers related to the elevation of IOP while
CBDVHS was not associated with elevating IOP at anti-fibrotic
concentrations.
In the second quarter
of 2019, UM also completed pre-clinical experiments showing that
NB2222 exhibited an ability to penetrate multiple chambers of the
eye and reach the optic nerve. These findings support the
therapeutic potential to provide ocular neuroprotection of retinal
ganglion cells, an important goal in treating diseases that lead to
vision loss. The data were published in the peer-reviewed Journal
of Ocular Pharmacology and Therapeutics in a paper titled, “Analog
Derivatization of Cannabidiol for Improved Ocular Permeation”
(2019; volume 35 (5): 1-10).
In February 2019, we
entered into the Noramco Agreement to provide manufacturing and
product development services for our analog formulation of CBD. We
paid $146,386 upfront and additional payments will be made upon
Noramco’s shipping of the active pharmaceutical ingredient to
us.
NB3111
NB3111 is a proprietary
cannabinoid cocktail currently undergoing testing as an
anti-infective agent against multiple strains of antibiotic
resistant bacteria, particularly methicillin-resistant
Staphylococcus aureus (“MRSA”). These studies look to examine the
utility of cannabinoid-based therapies against a variety of MRSA
strains and other gram-positive bacterial infections. We plan to
continue to present data from these studies at an upcoming
peer-reviewed scientific meeting focused on infectious
diseases.
Other Development
Programs
We plan to continue to
work with UM to explore other potential indications and associated
routes of administration based on the expanded UM5050 and UM 8930
licenses. Our decision to advance a potential therapeutic candidate
will be influenced by a number of criteria, including but not
limited to, pre-clinical data, synthesis and formulation capability
as well as prevailing market conditions.
In July 2019, we
engaged StemoniX to evaluate CBD and CBDVHS (and possibly
additional CBD-derivatives) in a human in vitro neural model with
an application to epilepsy. The series of experiments are designed
to provide insight into how these cannabinoids stabilize neuronal
cells. In November and December 2019, we also executed additional
pre-clinical research agreements with StemoniX related to
CBDVHS.
In December 2019, we
announced data generated by StemoniX, that CBDVHS was both
pharmacologically and therapeutically distinct from CBD when
studied in an in vitro human neural tissue model mimicking
chemically-induced seizure-like hyperactivity. Additionally, CBDVHS
was observed to gain potency in anti-seizure-like activity over the
seven-day observation period whereas the suppressive effect
afforded by CBD dissipated by day three. In assessing safety
parameters of CBDVHS, the molecule was not found to be toxic to the
neurologic cells tested in multiple assays, both in acute and
longer-term exposure.
Critical Accounting Policies and Estimates
Our
Management’s Discussion and Analysis of Financial Condition and
Results of Operations section discusses our financial statements,
which have been prepared in accordance with accounting principles
generally accepted in the United States of America. The preparation
of these financial statements requires management to make estimates
and assumptions that affect the reported amounts of assets and
liabilities at the date of the financial statements and the
reported amounts of income and expenses during the reporting
period. On an on-going basis, management evaluates its estimates
and judgments, including those related to accrued expenses,
financing operations, and contingencies and litigation. Management
bases its estimates and judgments on historical experience and on
various other factors that are believed to be reasonable under the
circumstances, the results of which form the basis for making
judgments about the carrying value of assets and liabilities that
are not readily apparent from other sources. Actual results may
differ from these estimates under different assumptions or
conditions. The most significant accounting estimates inherent in
the preparation of our financial statements include estimates as to
the appropriate carrying value of certain assets and liabilities
which are not readily apparent from other sources. We consider
certain accounting policies related to fair value measurements,
convertible instruments, warrants issued in connection with
financings, stock-based compensation expense, and earnings per
share to be critical accounting policies that require the use of
significant judgments and estimates relating to matters that are
inherently uncertain and may result in materially different results
under different assumptions and conditions.
Management assessed the critical accounting policies as disclosed
in our Annual Report on Form 10-K for the year ended December 31,
2019 and determined that there were no changes to our critical
accounting policies and estimates during the three months ended
March 31, 2020.
Recently Issued and Adopted Accounting
Pronouncements
See Note
2 to the accompanying condensed consolidated financial statements
included in Part I, Item 1 of this Quarterly Report on Form 10-Q
for information on recently issued accounting pronouncements and
recently adopted accounting pronouncements. While we expect certain
recently adopted accounting pronouncements to impact our estimates
in future periods, the impact upon adoption was not significant to
our current estimates and operations.
Results of Operations
For the three months ended March 31, 2020 and
2019
Revenues. To date, we have not generated any
revenues, and do not expect to generate any revenue from the sale
of products in the near future.
Operating expenses. For the three months ended
March 31, 2020, our total operating expenses were $2,211,208 as
compared to $1,515,067 for the three months ended March 31, 2019.
The increase in operating expenses was due to the items noted
below:
Research and development. Research and development expenses
for the three months ended March 31, 2020 were $799,612, which
consisted of expenses including salaries and benefits and
consulting fees for the staff involved in our preclinical and
clinical drug development activities, contract research and
development fees paid to UM, fees related to contract manufacturing
paid to Noramco, fees related to contract formulation work paid to
PII, a $200,000 license fee incurred under the UM 8930 Analog
Agreement for the receipt for the first United States Patent and
Trademark Office notice of allowance and the annual license
maintenance fee for UM 5070. Research and development expenses for
the three months ended March 31, 2019 were $320,986, which
consisted of the annual license maintenance fee for UM 5070,
contract research and development fees paid to UM and Glauconix,
regulatory consulting fees paid to RRD, and fees related contract
manufacturing paid to AMRI and ElSohly Laboratories. The increase
in research and development expenses was primarily due to increases
in license fees and contract manufacturing and formulation
expenses.
General and administrative. General and administrative
expenses for the three months ended March 31, 2020 were $1,411,596,
which primarily consisted of salaries, stock compensation expense,
general legal and patent related fees, consulting fees and
professional fees related to the Company’s capital raising efforts
and regulatory filings. By comparison, general and administrative
expenses for the three months ended March 31, 2019 were $1,194,081,
which primarily consisted of the same components. General and
administrative expenses increased period over period primarily due
to increased legal fees, higher accounting expenses related to the
Company’s increased fundraising efforts and additional investor
relations fees.
Other expense (income). For the three months ended
March 31, 2020, we had other expense of $130,452 related primarily
to interest expense of $166,355 which was offset by a decrease in
the fair value of our derivative liabilities of $35,903 which was
driven by the decrease in our stock price. The additional interest
expense that we recognized during the three months ended March 31,
2020, as compared to the three months ended March 31, 2019 was
related to the amortization of the debt discount and accrued
interest associated with the outstanding balance under the Credit
Agreement.
For the
three months ended March 31, 2019, we had other expense of
$13,259,325 related primarily to the increase in fair value of our
derivative liabilities which was driven by the increase in our
stock price. In addition, we initiated drawdowns under the Credit
Agreement which required us to bifurcate compound embedded
derivatives and record an additional charge for the fair value of
such instruments in excess of proceeds.
Net loss and comprehensive loss. For the three
months ended March 31, 2020, we had a net loss of $2,341,660 as
compared to a net loss of $14,774,392 for the three months ended
March 31, 2019. The change was primarily attributable to a decrease
in other expense which was partially offset by an increase in our
operating expenses. We expect to incur net losses for the
foreseeable future.
Liquidity and Capital Resources
We have
incurred operating losses and negative cash flows from operations
since our inception and as of March 31, 2020, had an accumulated
deficit of $34,514,942, a stockholders’ deficit of $1,702,897 and a
working capital deficit of $995,853. We anticipate that we will
continue to incur net losses into the foreseeable future in order
to advance and develop several potential drug candidates into
preclinical and clinical development activities and support our
corporate infrastructure, which includes the costs associated with
being a public company. We had cash of $563,864 as of March 31,
2020, as compared to $1,829,977 as of December 31, 2019. The
decrease was primarily attributable to a decrease in financing
activities during the quarter as compared to the three month period
ended March 31, 2019, when the Company received $3,990,699 in net
proceeds from the Credit Agreement (as defined below). Without
additional funding, management believes that we will not have
enough funds to meet our obligations beyond one year after the date
the Condensed Consolidated Financial Statements are issued. These
conditions give rise to substantial doubt as to our ability to
continue as a going concern.
On
October 5, 2018, we secured a Credit Agreement with Emerald Health
Sciences (the “Credit Agreement”), providing us with a credit
facility of up to $20,000,000. Under the Credit Agreement, we may
draw a remaining amount of up to $14,000,000 in advances from
Emerald Health Sciences from time to time, each in a principal
amount of at least $250,000. The advances are subject to approval
by our Board, which is controlled by the directors of Emerald
Health Sciences. As such, we do not consider the facility available
until advance requests are approved, drawn down and funded. As of
March 31, 2020, we have effected three drawdowns under the Credit
Agreement, each in the amount of $2,000,000, for an aggregate
principal amount of $6,000,000 in advances, and have issued to
Emerald Health Sciences warrants to purchase an aggregate of
7,500,000 shares of common stock at an exercise price of $0.50 per
share. On December 20, 2019, we entered into a Warrant Exercise
Agreement with Emerald Health Sciences, pursuant to which Emerald
Health Sciences has exercised 40,800,000 of such warrants and paid
the aggregate exercise price of approximately $4,080,000 for the
related warrant shares in the form of a reduction of the
corresponding amount of obligations outstanding under the Credit
Agreement. Upon consummation of the transactions under the Warrant
Exercise Agreement, the total outstanding principal amount
excluding discounts under the Credit Agreement was $2,014,500.
On April 22, 2020, we
entered into a Paycheck Protection Program Promissory Note (the
“PPP Note”) in the principal amount of $116,700 (the “PPP Loan”)
from City National Bank (the “PPP Loan Lender”). The PPP Loan was
obtained pursuant to the Paycheck Protection Program (the “PPP”) of
the Coronavirus Aid, Relief, and Economic Security Act (the “CARES
Act”) administered by the U.S. Small Business Administration
(“SBA”).
On April 29, 2020, we
entered into an Amended and Restated Multi-Draw Credit Agreement
with Emerald Health Sciences, which amends and restates the Credit
Agreement, as reported in the current report on the Form 8-K filed
with the SEC on April 29, 2020. The Amended Credit Agreement
provides for a credit facility to us in the principal amount of up
to $20,000,000, which includes, without limitation, the advances
totaling $6,000,000 that were granted prior to the amendment and
advances of at least $150,000 for each of May, June and July 2020.
Immediately upon entering into of the Amended Credit Agreement, we
effected a fourth drawdown in the amount of $150,000 (the
“Drawdown”) pursuant to the Amended Credit Agreement. The
Drawdown bears an interest at 7% per annum and matures on October
5, 2022. We intend to use the net proceeds of the Drawdown for
general corporate and working capital purposes.
We intend to continue
working toward identifying and obtaining new sources of financing.
No assurances can be given that we will be successful in obtaining
additional financing in the future. Any future financing that we
may obtain may cause significant dilution to existing stockholders.
Any debt financing or other financing of securities senior to
common stock that we are able to obtain will likely include
financial and other covenants that will restrict our flexibility.
Any failure to comply with these covenants would have a negative
impact on our business, prospects, financial condition, results of
operations and cash flows.
If adequate funds are
not available, we may be required to delay, scale back or eliminate
portions of our operations, cease operations or obtain funds
through arrangements with strategic partners or others that may
require us to relinquish rights to certain of our assets.
Accordingly, the inability to obtain such financing could result in
a significant loss of ownership and/or control of our assets and
could also adversely affect our ability to fund our continued
operations and our expansion efforts.
During the next twelve
months, we expect to incur significant research and development
expenses with respect to our products. The majority of our research
and development activity is focused on the development of potential
drug candidates, preclinical studies and preparing for clinical
trials.
We also expect to incur
significant legal and accounting costs in connection with being a
public company. We expect those fees will be significant and will
continue to impact our liquidity. Those fees will be higher as our
business volume and activity increases.
We also anticipate that
we will need to hire additional employees or independent
contractors as we prepare to enter clinical studies.
In
December 2019, a novel strain of coronavirus (“COVID-19”) emerged
in Wuhan, China. Since then, it has spread to the United States and
infections have been reported around the world. On March 11, 2020,
the World Health Organization declared the outbreak of COVID-19 as
a global pandemic, which continues to spread throughout the United
States, Australia and around the world, where the Company has
operations and conducts laboratory research and clinical studies.
In response to the outbreak, federal and state authorities in the
United States have introduced various recommendations and measures
to try to limit the pandemic, including travel restrictions, border
closures, nonessential business closures, quarantines,
self-isolations, shelters-in-place and social distancing. The
COVID-19 outbreak and the response of governmental authorities to
try to limit it are having a significant impact on the private
sector and individuals, including unprecedented business,
employment and significant economic disruptions to the global
financial markets. These disruptions could impact our ability to
raise additional capital and obtain the necessary funds.
Notably,
we rely on third-party manufacturers to produce our product
candidates. The manufacturing of the active pharmaceutical
ingredient of NB1111 is conducted in the United States. Formulation
of the eye drop for testing is also performed in the United States
but can rely on regulatory-accepted excipients that can be sourced
from countries outside the United States, such as China. In lieu of
the recent COVID-19 pandemic, there could possibly be an impact on
sourcing materials that are part of the eye drop formulation, as
well as impacting volunteer and/or patient recruitment in Australia
for clinical studies. Therefore, we have shifted the expected start
of our first-in-human studies of the lead drug candidate, NB1111,
from the second half of 2020, to the 2021 timeframe.
The
ultimate impact on us and overall delay in our drug product
research and development is unknown, but our operations and
financial condition will suffer in the event of business
interruptions, delayed clinical trials, production or a lack of
laboratory resources due to the pandemic. As of the date of this
filing, we are aware of the impact on our business as a result
of COVID-19 but uncertain as to the extent of this impact
on our condensed consolidated financial statements. There is
uncertainty as to the duration and hence the potential impact. As a
result, we are unable to estimate the potential impact on our
business as of the date of this filing.
Going Concern
Our
independent registered public accounting firm has issued a report
on our audited financial statements for the fiscal year ended
December 31, 2019 that included an explanatory paragraph referring
to our recurring operating losses and expressing substantial doubt
in our ability to continue as a going concern. Our condensed
consolidated financial statements have been prepared on a going
concern basis, which assumes the realization of assets and
settlement of liabilities in the normal course of business. Our
ability to continue as a going concern is dependent upon our
ability to generate profitable operations in the future and/or to
obtain the necessary financing to meet our obligations and repay
our liabilities arising from normal business operations when they
become due. The outcome of these matters cannot be predicted with
any certainty at this time and raise substantial doubt that we will
be able to continue as a going concern. Our condensed consolidated
financial statements do not include any adjustments to the amount
and classification of assets and liabilities that may be necessary
should we be unable to continue as a going concern.
Off-Balance Sheet Arrangements
There
are no off-balance sheet arrangements that have or are reasonably
likely to have a current or future effect on our financial
condition, changes in financial condition, revenues or expenses,
results of operations, liquidity, capital expenditures or capital
resources that is material to investors.
Item
3. Quantitative and Qualitative Disclosures about Market
Risk.
Not applicable.
Item
4. Controls and Procedures.
Evaluation of disclosure controls and procedures.
We maintain controls and procedures that are designed to ensure
that information required to be disclosed in the reports that we
file or submit under the Securities Exchange Act of 1934 is
recorded, processed, summarized and reported within the time
periods specified in the SEC’s rules and forms, and that such
information is accumulated and communicated to our management,
including our principal executive and principal financial officers,
as appropriate, to allow timely decisions regarding required
disclosures. In designing and evaluating the disclosure controls
and procedures, management recognizes that any control and
procedures, no matter how well designed and operated, can only
provide reasonable assurance of achieving the desired control
objectives, and in reaching a reasonable level of assurance,
management necessarily is required to apply its judgment in
evaluating the cost-benefit relationship of possible controls and
procedures.
We
conducted an evaluation, under the supervision and with the
participation of our principal executive and financial officers, of
the effectiveness of the design and operation of our disclosure
controls and procedures as of March 31, 2020. Based upon their
evaluation and subject to the foregoing, the principal executive
and financial officers have concluded that, as of the end of the
period covered by this report, the disclosure controls and
procedures were effective at a reasonable assurance level.
Changes in internal controls. Management
determined there were no changes in our internal control over
financial reporting that occurred during the fiscal quarter covered
by this report that have materially affected, or are reasonably
likely to materially affect, our internal control over financial
reporting.
PART II
- OTHER INFORMATION
Item 1.
Legal Proceedings
There have been no
other material developments with respect to previously reported
legal proceedings discussed in our Annual Report on Form 10-K for
the year ended December 31, 2019.
Item 1A. Risk
Factors.
Investing in our common
stock involves a high degree of risk. Our Annual Report on Form
10-K for the year ended December 31, 2019 includes a detailed
discussion of our risk factors under the heading “Part I, Item
1A-Risk Factors.” There are no changes from the risk factors
previously disclosed in our Annual Report on Form 10-K. You should
carefully consider the risk factors discussed in our Annual Report
on Form 10-K, as well as the other information in this report
before deciding whether to invest in shares of our common stock.
The occurrence of any of the risks discussed in the Annual Report
on Form 10-K could harm our business, financial condition, results
of operations or growth prospects. In that case, the trading price
of our common stock could decline, and you may lose all or part of
your investment.
Item 2.
Unregistered Sales of Equity Securities and Use of
Proceeds.
None.
Item 3. Defaults
Upon Senior Securities.
None.
Item 4. Mine
Safety Disclosures.
Not applicable.
Item 5. Other
Information.
None.
Item 6. Exhibits.
10.1
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Amended and Restated Multi-Draw Credit Agreement, dated April 29,
2020, by and between Emerald Bioscience, Inc. and Emerald Health
Sciences, Inc. (1)
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10.2
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Separation and Release Agreement, dated April 29, 2020, between
Emerald Bioscience, Inc. and Doug Cesario (1)
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31.1*
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Certification of
Principal Executive Officer, pursuant to Rule 13a-14 and 15d-14 of
the Securities Exchange Act of 1934
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31.2*
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Certification of
Principal Financial Officer, pursuant to Rule 13a-14 and 15d-14 of
the Securities Exchange Act of 1934
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32.1*
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Certification of
Principal Executive Officer, pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
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32.2*
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Certification of
Principal Financial Officer, pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
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________
(1)
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Included as exhibit to our Current
Report on Form 8-K filed on April 29, 2020. |
(*) Filed herewith.
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
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Emerald
Bioscience, Inc.,
a Nevada
corporation
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May 8, 2020
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By:
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/s/ Brian
Murphy
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Brian Murphy
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Its:
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Chief Executive
Officer
(Principal Executive
Officer)
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May 8, 2020
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By:
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/s/ Doug
Cesario
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Doug Cesario
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Its:
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Chief Financial
Officer
(Principal Financial
and Accounting Officer)
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