UNITED
STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
FORM 10-Q
(Mark One)
☒
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
|
|
|
For the quarterly period
ended June 30, 2020
|
or
☐
|
TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
|
|
|
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.)
|
5910 Pacific
Center Blvd, San Diego, CA 92121
|
(Address of principal
executive offices) (Zip Code)
|
(949)
480-9051
|
(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. ☒
Yes ☐ No
Indicate by check mark
whether the registrant has submitted electronically every
Interactive Data File required to be submitted pursuant to Rule 405
of Regulation S-T (§232.405 of this chapter) during the preceding
12 months (or for such shorter period that the registrant was
required to submit such files). ☒
Yes ☐ No
Indicate by check mark
whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, 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
|
☐
|
Accelerated filer
|
☐
|
Non-accelerated
filer
|
☒
|
Smaller reporting
company
|
☒
|
|
Emerging growth
company
|
☐
|
If an emerging growth
company, indicate by check mark if the registrant has elected not
to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section
13(a) of the Exchange Act. ☐
Indicate by check mark
whether the registrant is a shell company (as defined in Rule 12b-2
of the Exchange Act). ☐ Yes ☒
No
As of August 12,
2020, there were 239,541,081 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
|
|
June
30,
2020
(Unaudited)
|
|
|
December
31,
2019
(Note
2)
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash
|
|
$ |
102,524 |
|
|
$ |
1,829,977 |
|
Restricted
cash
|
|
|
4,538 |
|
|
|
4,538 |
|
Prepaid
expenses
|
|
|
114,250 |
|
|
|
152,695 |
|
Other
current assets
|
|
|
4,643 |
|
|
|
7,550 |
|
Total
current assets
|
|
|
225,955 |
|
|
|
1,994,760 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net
|
|
|
1,252 |
|
|
|
1,983 |
|
Total
assets
|
|
$ |
227,207 |
|
|
$ |
1,996,743 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ (DEFICIT)
EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
1,096,283 |
|
|
$ |
129,809 |
|
Accounts
payable to related party
|
|
|
77,290 |
|
|
|
10,000 |
|
Accrued
interest due to related party
|
|
|
37,726 |
|
|
|
- |
|
PPP loan
current
|
|
|
51,653 |
|
|
|
- |
|
Other
current liabilities
|
|
|
426,884 |
|
|
|
420,406 |
|
Derivative
liabilities
|
|
|
465,287 |
|
|
|
410,603 |
|
Total
current liabilities
|
|
|
2,155,123 |
|
|
|
970,818 |
|
|
|
|
|
|
|
|
|
|
Noncurrent
liabilities
|
|
|
|
|
|
|
|
|
PPP loan
non-current
|
|
|
65,047 |
|
|
|
- |
|
Multi-draw
credit agreement - related party
|
|
|
450,000 |
|
|
|
- |
|
Convertible multi-draw credit agreement - related party, net of
discount
|
|
|
651,461 |
|
|
|
387,070 |
|
Derivative
liabilities, non-current
|
|
|
- |
|
|
|
90,797 |
|
Total
liabilities
|
|
|
3,321,631 |
|
|
|
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 June 30, 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 June 30, 2020 and December 31, 2019,
respectively
|
|
|
183,208 |
|
|
|
182,895 |
|
Additional
paid-in-capital
|
|
|
32,657,546 |
|
|
|
32,538,445 |
|
Accumulated deficit
|
|
|
(35,935,178 |
) |
|
|
(32,173,282 |
) |
Total
stockholders’ (deficit) equity
|
|
|
(3,094,424 |
) |
|
|
548,058 |
|
Total
liabilities and stockholders’ (deficit) equity
|
|
$ |
227,207 |
|
|
$ |
1,996,743 |
|
|
|
|
|
|
|
|
|
|
See accompanying notes
to the condensed consolidated financial statements.
|
EMERALD BIOSCIENCE, INC. AND
SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS)
INCOME
(UNAUDITED)
|
|
For the Three
Months Ended
June
30,
|
|
|
For the Six
Months Ended
June
30,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$ |
428,529 |
|
|
$ |
688,041 |
|
|
$ |
1,228,141 |
|
|
$ |
1,009,026 |
|
General and
administrative
|
|
|
792,129 |
|
|
|
1,082,846 |
|
|
|
2,203,725 |
|
|
|
2,276,928 |
|
Total operating expenses
|
|
|
1,220,658 |
|
|
|
1,770,887 |
|
|
|
3,431,866 |
|
|
|
3,285,954 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
|
(1,220,658 |
) |
|
|
(1,770,887 |
) |
|
|
(3,431,866 |
) |
|
|
(3,285,954 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense
(income)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of
derivative liabilities
|
|
|
26,353 |
|
|
|
(17,971,742 |
) |
|
|
(9,550 |
) |
|
|
(5,151,124 |
) |
Fair value of derivative
liabilities in excess of proceeds
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
322,644 |
|
Interest expense
|
|
|
171,625 |
|
|
|
293,965 |
|
|
|
337,980 |
|
|
|
410,028 |
|
Total other expense (income),
net
|
|
|
197,978 |
|
|
|
(17,677,777 |
) |
|
|
328,430 |
|
|
|
(4,418,452 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income
before income taxes
|
|
|
(1,418,636 |
) |
|
|
15,906,890 |
|
|
|
(3,760,296 |
) |
|
|
1,132,498 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for income
taxes
|
|
|
1,600 |
|
|
|
1,600 |
|
|
|
1,600 |
|
|
|
1,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)
income and comprehensive (loss) income
|
|
$ |
(1,420,236 |
) |
|
$ |
15,905,290 |
|
|
$ |
(3,761,896 |
) |
|
$ |
1,130,898 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings
per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
(0.01 |
) |
|
$ |
0.12 |
|
|
$ |
(0.02 |
) |
|
$ |
0.01 |
|
Diluted
|
|
$ |
(0.01 |
) |
|
$ |
0.08 |
|
|
$ |
(0.02 |
) |
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares of common stock outstanding used to compute earnings
per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
183,052,175 |
|
|
|
132,923,037 |
|
|
|
182,654,571 |
|
|
|
132,826,677 |
|
Diluted
|
|
|
183,052,175 |
|
|
|
189,094,958 |
|
|
|
182,654,571 |
|
|
|
172,058,053 |
|
See accompanying notes
to the condensed consolidated financial statements.
EMERALD BIOSCIENCE, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS
(UNAUDITED)
|
|
For the Six
Months Ended
June
30,
|
|
|
|
2020
|
|
|
2019
|
|
|
|
|
|
|
|
|
Cash flows from
operating activities:
|
|
|
|
|
|
|
Net (loss) income
|
|
$ |
(3,761,896 |
) |
|
$ |
1,130,898 |
|
Adjustments to reconcile net
(loss) income to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
731 |
|
|
|
731 |
|
Stock-based compensation
expense
|
|
|
92,851 |
|
|
|
344,577 |
|
Change in fair value of
derivative liabilities
|
|
|
(9,550 |
) |
|
|
(5,151,124 |
) |
Fair value of derivative
liabilities in excess of proceeds
|
|
|
- |
|
|
|
322,644 |
|
Amortization of debt
discount
|
|
|
264,391 |
|
|
|
244,751 |
|
Changes in assets and
liabilities:
|
|
|
|
|
|
|
|
|
Prepaid expenses
|
|
|
38,445 |
|
|
|
(169,079 |
) |
Other current assets
|
|
|
2,907 |
|
|
|
- |
|
Accounts payable
|
|
|
966,474 |
|
|
|
57,862 |
|
Accounts payable to related
party
|
|
|
67,290 |
|
|
|
- |
|
Accrued interest related
party
|
|
|
37,726 |
|
|
|
- |
|
Other current liabilities
|
|
|
6,478 |
|
|
|
182,494 |
|
Net cash used in operating
activities
|
|
|
(2,294,153 |
) |
|
|
(3,036,246 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities:
|
|
|
|
|
|
|
|
|
Proceeds from PPP loan
|
|
|
116,700 |
|
|
|
- |
|
Proceeds from multi-draw credit
agreement – related party, net of $0 and $9,301 issuance costs for
the June 30, 2020 and June 30, 2019 periods, respectively
|
|
|
450,000 |
|
|
|
3,990,699 |
|
Net cash provided by financing
activities
|
|
|
566,700 |
|
|
|
3,990,699 |
|
|
|
|
|
|
|
|
|
|
Net (decrease)
increase in cash and restricted cash
|
|
|
(1,727,453 |
) |
|
|
954,453 |
|
|
|
|
|
|
|
|
|
|
Cash and
restricted cash, beginning of period
|
|
$ |
1,834,515 |
|
|
$ |
1,857,885 |
|
|
|
|
|
|
|
|
|
|
Cash and
restricted cash, end of period
|
|
$ |
107,062 |
|
|
$ |
2,812,338 |
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosures of cash-flow information:
|
|
|
|
|
|
|
|
|
Reconciliation of cash
and restricted cash:
|
|
|
|
|
|
|
|
|
Cash
|
|
$ |
102,524 |
|
|
$ |
2,807,826 |
|
Restricted cash
|
|
|
4,538 |
|
|
|
4,512 |
|
Total cash and restricted cash
shown in the consolidated statements of cash flows
|
|
$ |
107,062 |
|
|
$ |
2,812,338 |
|
|
|
|
|
|
|
|
|
|
Cash paid during the
period for:
|
|
|
|
|
|
|
|
|
Interest
|
|
$ |
- |
|
|
$ |
165,277 |
|
Income taxes
|
|
|
1,600 |
|
|
|
1,600 |
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosures of non-cash financing activities:
|
|
|
|
|
|
|
|
|
Reclassification of warrant
liabilities to equity from exercise of warrants
|
|
$ |
26,563 |
|
|
$ |
144,375 |
|
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 |
|
Beneficial conversion feature on
convertible multi-draw credit agreement
|
|
|
- |
|
|
|
1,584,850 |
|
|
|
|
|
|
|
|
|
|
See accompanying notes
to the condensed consolidated financial statements.
|
|
|
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 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
|
|
- |
|
|
|
- |
|
|
|
173,084 |
|
|
|
- |
|
|
|
173,084 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series B warrant
exercises
|
|
|
187,500 |
|
|
|
187 |
|
|
|
144,188 |
|
|
|
- |
|
|
|
144,375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income for the
three months ended June 30, 2019
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
15,905,290 |
|
|
|
15,905,290 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June
30, 2019
|
|
|
134,095,247 |
|
|
$ |
134,095 |
|
|
$ |
20,318,672 |
|
|
$ |
(32,094,209 |
) |
|
$ |
(11,641,442 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense
|
|
|
- |
|
|
|
- |
|
|
|
28,709 |
|
|
|
- |
|
|
|
28,709 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the three months ended June 30,
2020
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,420,236 |
) |
|
|
(1,420,236 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2020
|
|
|
183,207,747 |
|
|
$ |
183,208 |
|
|
$ |
32,657,546 |
|
|
$ |
(35,935,178 |
) |
|
$ |
(3,094,424 |
) |
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 to form a Nevada
company.
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 August 7, 2020, Dr.
Brian Murphy resigned and Punit Dhillon was appointed as the Chief
Executive Officer of the Company (Note 8).
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 San Diego, 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 June 30, 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 June 30, 2020, had an accumulated deficit
of $35,935,178, a stockholders’ deficit of $3,094,424 and a working
capital deficit of $1,929,168. The Company anticipates 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 June 30, 2020, the
Company had unrestricted cash in the amount of $102,524 as compared
to $1,829,977 as of December 31, 2019.
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 expected cash
requirements, without obtaining additional funding management
believes that the Company will not have enough funds to 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.
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.
During the three months
ended June 30, 2020 the Company effected the fourth and fifth
advances under the Amended Credit Agreement in the amounts of
$150,000 and $300,000, respectively. The advances bear interest at
7% per annum and mature on October 5, 2022. The Company intends to
use the proceeds from the advances for general corporate and
working capital purposes. Emerald Health Sciences has elected that
the fourth and fifth advances will not be convertible into shares
of Common Stock and that no warrants will be issued with the
advances.
On April 22, 2020, the
Company entered into a Paycheck Protection Program Promissory 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”) (Note 4).
On July 31, 2020, the
Company entered into the August 2020 Financing (Note 8), pursuant
to which the Company sold 56,333,334 common stock units each
consisting of one share of common stock and one common stock
warrant and 60,333,334 pre-funded units each consisting of one
pre-funded warrant and one common stock warrant in a registered
public offering. The net proceeds from the transaction are $6.1
million. The common stock warrants and prefunded warrants have an
exercise price of $0.06 and $0.001, respectively. The term of the
common stock warrants is five years and the pre-funded warrants are
exercisable until all the pre-funded warrants have been exercised
in full. The Company intends to use the net proceeds of the
Offering for general corporate purposes, including working
capital.
During March 2020, the
Company approved a plan to defer up to 50% of the members of senior
management’s compensation and 100% of the Board of Director and
committee fees indefinitely. In August 2020, subsequent to closing
the August 2020 Financing, the Board of Directors determined that
the Company has been sufficiently financed and authorized the
Company to pay the deferred compensation and fee balances together
with a retention bonus of 10% of such balance.
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.
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
connection with 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. The location of the
proposed clinical trial is Melbourne, Australia and since the
COVID-19 outbreak in that country, the city has experienced
multiple health emergency lockdowns which have had a negative
impact on the conduct and timelines of 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 disclosures 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 and six months ended June 30, 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.
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
Amended Credit Agreement and derivative liabilities, including,
cash, prepaid expenses, accounts payable, the PPP loan 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 (Note 3). The PPP loan is considered conventional debt with
an interest rate that approximates current market rates, interest
and principal payments will be made through 2022. Due to the PPP
loan’s relatively short term the carrying value approximates fair
value. As of December 31, 2019, the fair value of the
advances under the Credit Agreement was $1,877,938, the carrying
amount of the liability at December 31, 2019 was $387,070 and
is included in Convertible multi-draw credit agreement - related
party, net of discount in the Company’s Condensed Consolidated
Balance Sheets. As of June 30, 2020, the Company no longer engages
a third party valuation specialist to value the Credit Agreement,
as amended, as it is not practical to do so solely for the purpose
of disclosing the estimated fair value of the financial instrument.
Information pertinent to estimating the fair value of the Amended
Credit Agreement includes valuing the embedded conversion feature
and considering the discounted cash flows of the interest and
principal payments through maturity (Note 4).
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) Income.
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) Income
.
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.
|
(Loss)
Earnings Per Common Share
The Company applies
FASB ASC No. 260, Earnings per Share in calculating its
basic and diluted net (loss) earnings per common share. Basic
(loss) earnings per share of common stock is computed by dividing
net (loss) income available to common stockholders by the
weighted-average number of shares of common stock outstanding for
the period. The diluted (loss) earnings 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
(earnings) per share of common stock for the periods presented
because including them would have been anti-dilutive:
|
|
Three
Months
Ended June
30,
(Unaudited)
|
|
|
Six
Months
Ended June
30,
(Unaudited)
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
Stock options
|
|
|
4,186,786 |
|
|
|
2,411,846 |
|
|
|
4,186,786 |
|
|
|
2,814,505 |
|
Unvested restricted
stock
|
|
|
- |
|
|
|
209,055 |
|
|
|
- |
|
|
|
237,798 |
|
Common shares
underlying convertible debt
|
|
|
5,125,364 |
|
|
|
- |
|
|
|
5,125,364 |
|
|
|
11,722,222 |
|
Warrants
|
|
|
22,304,750 |
|
|
|
18,844,002 |
|
|
|
22,304,750 |
|
|
|
20,353,145 |
|
Recent
Accounting Pronouncements
In August 2020, the
FASB issued ASU 2020-06, Debt—Debt with Conversion and Other
Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in
Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible
Instruments and Contracts in an Entity’s Own Equity. This ASU
amends the guidance on convertible instruments and the derivatives
scope exception for contracts in an entity’s own equity and
improves and amends the related EPS guidance for both Subtopics.
The ASU will be effective for annual reporting periods after
December 15, 2023 and interim periods within those annual periods
and early adoption is permitted in annual reporting periods ending
after December 15, 2020. We are still assessing the impact of ASU
2020-06 on our condensed consolidated financial statements.
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.
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 June 30, 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
|
|
|
|
1,660,000 |
|
2015 Common Stock
Warrants
|
|
$ |
1.15-5.00
|
|
|
5-10
|
|
|
|
256,000 |
|
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 June 30, 2020
|
|
|
|
|
|
|
|
|
|
|
22,304,750 |
|
Emerald Multi-Draw
Credit Agreement Warrants
During the six months
ended June 30, 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 were 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:
|
|
Six Months Ended
June 30, 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
|
|
|
June
30,
2020,
Fair
Value
of
Derivative
Liabilities
|
|
Emerald Multi-Draw Credit
Agreement - compound derivative liability (1)
|
|
$ |
90,797 |
|
|
$ |
- |
|
|
$ |
(90,797 |
) |
|
$ |
- |
|
|
$ |
- |
|
Emerald Financing - warrant liability
(2)
|
|
|
276,024 |
|
|
|
- |
|
|
|
76,708 |
|
|
|
- |
|
|
|
352,732 |
|
Series B - warrant
liability (3)
|
|
|
134,579 |
|
|
|
- |
|
|
|
4,539 |
|
|
|
(26,563 |
) |
|
|
112,555 |
|
Total
derivative liabilities
|
|
$ |
501,400 |
|
|
$ |
- |
|
|
$ |
(9,550 |
) |
|
$ |
(26,563 |
) |
|
$ |
465,287 |
|
Less, noncurrent
portion of derivative liabilities
|
|
|
(90,797 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
- |
|
Current balance of derivative
liabilities
|
|
$ |
410,603 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
465,287 |
|
|
|
Six Months Ended
June 30, 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
|
|
|
June
30,
2019,
Fair
Value
of
Derivative
Liabilities
|
|
Emerald Multi Draw
Credit Agreement - compound derivative liability (1)
|
|
$ |
219,453 |
|
|
$ |
516,058 |
|
|
$ |
(219,134 |
) |
|
$ |
- |
|
|
$ |
516,377 |
|
Emerald Financing -
warrant liability (2)
|
|
|
15,251,413 |
|
|
|
- |
|
|
|
(4,887,929 |
) |
|
|
- |
|
|
|
10,363,484 |
|
Series B - warrant
liability (3)
|
|
|
487,500 |
|
|
|
- |
|
|
|
(44,061 |
) |
|
|
(144,375 |
) |
|
|
299,064 |
|
Total
derivative liabilities
|
|
$ |
15,958,366 |
|
|
$ |
516,058 |
|
|
$ |
(5,151,124 |
) |
|
$ |
(144,375 |
) |
|
$ |
11,178,925 |
|
Less, noncurrent
portion of derivative liabilities
|
|
|
(219,453 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(516,377 |
) |
Current balance
of derivative liabilities
|
|
$ |
15,738,913 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
10,662,548 |
|
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 was 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
was measured using a standard Black-Scholes model for each payment
period.
On April 29, 2020, the
Company entered into the Amended Credit Agreement which removed the
change in control provision as an event of default for advances
before and after the amendment. As a result of the modification,
the contingent interest feature component of the compound
derivative is no longer required to be bifurcated as a derivative
liability. For the three and six months ended June 30, 2020, the
liability has been reduced to $0 through an adjustment to the
change in fair value of derivative liabilities.
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
considered de minimis before and after the amendment to the Credit
Agreement.
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:
|
|
June
30,
2020
|
|
|
December
31,
2019
|
|
Dividend yield
|
|
|
0.00 |
% |
|
|
0.00 |
% |
Volatility factor
|
|
|
82.2 |
% |
|
|
79.5 |
% |
Risk-free interest
rate
|
|
|
0.17 |
% |
|
|
1.62 |
% |
Expected term
(years)
|
|
|
2.63 |
|
|
|
3.13 |
|
Underlying common stock
price
|
|
$ |
0.16 |
|
|
$ |
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
June
30,
2020
|
|
|
As
of
December
31,
2019
|
|
Dividend yield
|
|
|
0.00 |
% |
|
|
0.00 |
% |
Volatility factor
|
|
|
104.9 |
% |
|
|
79.2 |
% |
Risk-free interest
rate
|
|
|
0.16 |
% |
|
|
1.60 |
% |
Expected term
(years)
|
|
|
0.14 |
|
|
|
0.64 |
|
Underlying common stock
price
|
|
$ |
0.16 |
|
|
$ |
0.13 |
|
During the six months
ended June 30, 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.
Debt
Multi-Draw Credit
Agreement- Related Party
The Company’s Debt with
Emerald Health Sciences consists of the following:
|
|
Conversion
Price
|
|
|
As
of
June
30,
2020
|
|
|
As
of
December
31,
2019
|
|
Total principal value
of convertible debt—related party
|
|
$ |
0.40 |
|
|
$ |
2,014,500 |
|
|
$ |
2,014,500 |
|
Unamortized debt
discount
|
|
|
|
|
|
|
(1,358,687 |
) |
|
|
(1,622,344 |
) |
Unamortized debt
issuance costs
|
|
|
|
|
|
|
(4,352 |
) |
|
|
(5,086 |
) |
Carrying value
of total convertible debt - related party
|
|
|
|
|
|
|
651,461 |
|
|
|
387,070 |
|
Total principal value
of non-convertible debt—related party
|
|
|
n/a |
|
|
|
450,000 |
|
|
|
- |
|
Total carrying
value of advances under the multi-draw credit
agreement
|
|
|
|
|
|
$ |
1,101,461 |
|
|
$ |
387,070 |
|
On October 5, 2018, the
Company entered into the Credit Agreement with Emerald Health
Sciences, a related party (See Note 7). On April 29, 2020, the
Company entered into the Amended Credit Agreement with Emerald
Health Sciences, which amends and restates the Credit Agreement,
dated October 5, 2018. For all pre-existing and new advances, the
Amended Credit Agreement removed the change in control as an event
of default (See Note 3) and defers the quarterly payment of
interest until the Company completes a capital raise of at least
$5,000,000. The amendments to the pre-existing advances were
accounted for as a modification. For all advances made after the
Credit Agreement was amended, advances will be convertible at a
reduced conversion price of $0.25 per share of Common Stock, unless
Emerald Health Sciences provides notice that the advance will not
be convertible.
For all outstanding
advances, the Amended Credit Agreement provides for a credit
facility to the Company of up to $20,000,000 and is unsecured.
Advances under the Amended Credit Agreement bear interest at an
annual rate of 7% and mature on October 5, 2022. At Emerald Health
Sciences’ election, convertible advances and unpaid interest may be
converted into common stock at the fixed conversion price of the
underlying advance, subject to customary adjustments for stock
splits, stock dividends, recapitalizations, etc. As of June 30,
2020, the unused portion of the credit facility is $13,550,000. The
drawdowns are subject to approval by the Company’s Board, which is
controlled by the directors of Emerald Health Sciences. As such,
the Company does not consider the facility available until advance
requests are approved, drawn down and funded. The Amended Credit
Agreement is still in place, however, there is no guarantee of
continued funding.
The Amended 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. 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 Amended 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 Amended 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 Amended Credit Agreement, the Company has 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 a term of five years that are immediately exercisable upon
issuance. Under the Amended Credit Agreement, Emerald Health
Sciences may issue notice that no warrants will be granted at the
time of the advance request. The warrants issued under the Credit
Agreement have an exercise price of $0.50 per share and any
warrants issued under the Amended Credit Agreement will have a
reduced exercise price of $0.35 per share. The exercise prices are
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
advance and the warrants issued under the Amended 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 Amended 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, an
initial advance was made for $2,000,000 and the Company issued
2,500,000 warrants with an exercise price of $0.50 per share (See
Note 3). In accounting for the convertible advance 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 six months
ended June 30, 2019, the Company initiated two advances, 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 with an exercise price of $0.50 per share (See Note 3). In
accounting for the convertible advances and warrants, 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 were 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)
Income for the six months ended June 30, 2019, as the value of the
beneficial conversion feature exceeded the proceeds allocated to
the third draw.
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 outstanding principal balance. 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.
During the three months
ended June 30, 2020, the Company effected a fourth and fifth
advances in the amounts of $150,000 and $300,000, respectively. The
Lender has elected that the fourth and fifth advances will not be
convertible into shares of Common Stock and gave notice to the
Company that no warrants will be issued in connection with the
advances.
Aggregate financing
costs of $63,007 have been incurred and are 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 Amended Credit Agreement. As of June 30, 2020,
the unamortized debt discount on the convertible advances will be
amortized over a remaining period of approximately 2.27 years. The
fair value of the shares underlying the convertible advances under
the Amended Credit agreement was $790,691 at June 30, 2020. As of
June 30, 2020, the if-converted value did not exceed the principal
balance.
PPP Loan
On April 24, 2020, the
Company received funding from the PPP Loan Lender pursuant to the
PPP of the CARES Act administered by the SBA for a principal amount
of $116,700. The PPP Loan matures on April 24, 2022 and bears
interest at a rate of 1.00% per year. Interest and principal are
payable monthly commencing seven months from the date of funding.
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 the
principal from 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
an eight-week period, or a longer period if elected by the Company,
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
seven-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.
Interest
Expense
The Company’s interest
expense consists of the following:
|
|
Three Months
Ended
June 30,
|
|
|
Six Months
Ended
June
30,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
Related party interest
expense – stated rate
|
|
$ |
37,726 |
|
|
$ |
106,167 |
|
|
$ |
73,371 |
|
|
$ |
165,277 |
|
PPP loan interest
expense – stated rate
|
|
|
218 |
|
|
|
- |
|
|
|
218 |
|
|
|
- |
|
Non-cash interest
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of debt
discount
|
|
|
133,310 |
|
|
|
184,313 |
|
|
|
263,657 |
|
|
|
238,293 |
|
Amortization of transaction
costs
|
|
|
371 |
|
|
|
3,485 |
|
|
|
734 |
|
|
|
6,458 |
|
|
|
$ |
171,625 |
|
|
$ |
293,965 |
|
|
$ |
337,980 |
|
|
$ |
410,028 |
|
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 June 30, 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 and six
months ended June 30, 2020.
Restricted Stock
Awards
During the three and
six months ended June 30, 2020, 643,501 restricted stock awards
(“RSAs”) with a weighted average grant date fair value of $0.26
vested and were released from their service condition restriction.
At June 30, 2020, there are no unvested RSA awards outstanding
under the 2014 Plan.
Awards
Granted Outside the 2014 Plan
Options
During the three and
six months ended June 30, 2020, 325,929 stock options with a
weighted average exercise price of $0.25 were forfeited in
connection with the separation and release of the Company’s former
CFO. At June 30, 2020 there are 869,144 options vested and
outstanding with a weighted average exercise price of $0.25 and a
weighted average remaining life of 0.13 years.
Restricted Stock
Awards
The following is a
summary of RSA activity outside of the Company’s 2014 Plan during
the six months ended June 30, 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, June
30, 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 June 30, 2020
and 2019, the Company recognized stock-based compensation expense
of $28,709 and $173,084, 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) Income. For the six months ended June 30,
2020 and 2019, the Company recognized stock-based compensation
expense of $92,851 and $344,577, 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) Income .The total
amount of unrecognized compensation cost was $164,798 as of June
30, 2020. This amount will be recognized over a weighted average
period of 2.18 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).
|
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 June 30, 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 June 30, 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
June 30, 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 and six months ended June 30, 2020. Under this agreement, for
the three and six months ended June 30, 2019, the Company incurred
expenses of $150,000 and $300,000, respectively.
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. Under this agreement, for the three and six months
ended June 30, 2020, the Company incurred fees of $36,387 and
$66,387, respectively. As of June 30, 2020, the Company has accrued
$70,258 in expense related to the Independent Contractor Services
Agreement.
As of the date of this
filing Jim Heppell and Punit Dhillon are board members of the
Company and Emerald Health Pharmaceuticals, a subsidiary of Emerald
Health Sciences, Inc. Jim Heppell is also a board member of Emerald
Health Sciences, Inc. Additionally, the Company shares the same
office location as Emerald Health Pharmaceuticals.
8. Subsequent
Events
August 2020
Financing
On July 31, 2020, the
Company entered into a Securities Purchase Agreement with
institutional investors with H.C. Wainwright & Co., LLC acting
as the placement agent, pursuant to which the Company sold
56,333,334 common stock units each consisting of one share of
common stock and one common stock warrant and 60,333,334 pre-funded
units each consisting of one pre-funded warrant and one common
stock warrant in a registered public offering. The common units and
pre-funded units were sold a price per unit of $0.06 and $0.059,
respectively, for gross aggregate proceeds of $6,939,667. The
common stock warrants and prefunded warrants have an exercise price
of $0.06 and $0.001, respectively. The term of the common stock
warrants is five years and the pre-funded warrants are exercisable
until all the pre-funded warrants have been exercised in full. The
exercise price and number of shares of Common Stock underlying the
Warrants are subject to adjustment upon the issuance by the Company
of stock dividends, stock splits, and similar proportionately
applied changes affecting the Company’s outstanding Common Stock.
Holders of the Warrants will be entitled to participate in any
dividends or other distribution of the Company’s assets declared or
made to holders of the Company’s Common Stock.
In connection with the
registered public offering, the Company incurred issuance costs of
$825,698, for net proceeds of $6,113,969. Additionally, the Company
has issued 8,166,667 common stock warrants to the placement agent,
which represent 7% of the total shares of common stock and
pre-funded warrants sold in the offering. The placement agent
warrants have an exercise price of $0.075 per share and a term of
five years. The offering closed on August 4, 2020. The Company
intends to use the net proceeds of the offering for general
corporate purposes, including working capital.
Management
and Board Deferral Agreements
Upon the closing of the
August 2020 financing, the Company’s Board of Directors determined
that the Company had been sufficiently financed to pay the deferred
salaries and fees including the retention bonus to management and
the Board in the aggregate amount of $293,078.
Exercise
Price Adjustment to Emerald Financing Warrants
Upon entering into the
August 2020 Financing, the Company entered into an agreement with a
holder of the Emerald Financing Warrants to permanently set the
exercise price of such holder’s remaining Emerald Financing
warrants to $0.10 and waive such holder’s rights to anti-dilution
protection upon subsequent issuances or sales of common stock,
stock options, or convertible securities at a price less than the
exercise price of $0.10.
Stock
Option Grants
In August 2020,
22,750,000 stock options with an exercise price of $0.045 were
granted to certain directors, officers, employees and consultants
of the Company under the 2014 Plan. The stock options will vest 10%
on the grant date and 90% in equal semi-annual installments over
the vesting schedules as set forth by the Company’s Board of
Directors.
On August 7, 2020, the
Board approved an Amendment No. 2 to the 2014 Plan. The amendment
removed certain restrictions on the number of shares of common
stock and the amount of cash-based awards up to which participants
of the 2014 Plan can receive in a calendar year. In connection
with the option grants the Company will register an additional
18,486,435 common shares as required under the 2014 Plan.
Separation
of Chief Executive Officer, Chief Medical Officer and Member of the
Board
On August 7, 2020, the
effective date, Company entered into a Separation and Release
Agreement (the “Separation Agreement”) with Dr. Brian Murphy, Chief
Executive Officer.
Pursuant to the
Separation Agreement, Dr. Murphy 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 Dr.
Murphy compensation and benefits as follows: (i) a gross payment of
$195,000 in consideration for the restrictive covenants contained
in the Separation Agreement, to be paid over six months;
and (ii) a continuation of health insurance benefits for a
period of six months following the Separation Date.
Appointment
of Chief Executive Officer
On August 7, 2020,
Punit Dhillon resigned his position as the Chair of the Audit
Committee and member of the Compensation, Nomination and Corporate
Governance Committees and was appointed as the Chief Executive
Officer of the Company. Mr. Dhillon remains as the Chairman of the
Board and Chairman of the Finance and Business Development
Committee. Mr. Dhillon will be eligible to receive a minimum
of 6 months’ severance if he is terminated by the Company without
cause and will receive 12-months’ severance if he is employed by
the Company for at least 12 months commencing on August 10, 2020,
or a 24 months’ severance if he is employed by the Company for at
least 24 months commencing on August 10, 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 and six months ended June 30, 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 connection with 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 six
months ended June 30, 2020, we achieved various milestones related
to the research and development of NB1111, including the
following:
|
•
|
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.
|
|
|
|
|
•
|
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. These
data were consistent with in vivo rabbit IOP response data
that was conducted in parallel to the Glauconix study as were
internal Glauconix validation testing using cannabinoid receptor
stimulator molecules that acted as proxy receptor agonists for THC,
the active moiety of NB1111.
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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 (CBDVHS). 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 and viral
species.
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 and six months ended June 30, 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 June 30, 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 June 30, 2020, our
total operating expenses were $1,220,658 as compared to $1,770,887
for the three months ended June 30, 2019. The decrease in operating
expenses was due to the items noted below:
Research and
development. Research and development expenses for the three
months ended June 30, 2020 were $428,529, which consisted of
expenses including salaries and benefits and consulting fees for
the staff involved in our preclinical and clinical drug development
activities, the annual license maintenance fee paid to UM, and fees
related to contract manufacturing paid to Noramco. Research and
development expenses for the three months ended June 30, 2019 were
$688,041, which consisted of the upfront payments for the all
fields of use licenses for UM 5050 and UM 8930, contract research
and development fees paid to UM, regulatory consulting fees paid to
RRD, and fees related contract manufacturing paid to AMRI and
Noramco. The decrease in research and development expenses was
primarily due to a decrease contract manufacturing activity,
regulatory consulting fees and license fees during the three months
ended June 30, 2020.
General and
administrative. General and administrative expenses for the
three months ended June 30, 2020 were $792,129, which primarily
consisted of salaries, general legal, insurance, 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 June 30, 2019
were $1,082,846, which primarily consisted of salaries, stock
compensation expense, general legal, consulting fees and
professional fees related to the Company’s capital raising efforts
and regulatory filings. General and administrative expenses
decreased period over period primarily due to decreases in travel
costs, consulting and legal legal fees and stock compensation
expenses which were offset by an increase in salaries due to
increased severance from the separation of our former CFO.
Other expense
(income). For the three months ended June 30, 2020, we had
other expense of $197,978 related primarily to interest expense of
$171,625 and an increase in the fair value of our derivative
liabilities of $26,353.
For the three months
ended June 30, 2019, the Company had other income of $17,677,777
related primarily to the decrease in fair value of our derivative
liabilities by $17,971,742 which was driven by the decrease in our
stock price.
The decrease in
interest expense period over period was related to a lower
principal balance on the Credit Agreement from the paydown of the
facility in December 2019.
Net (loss)
income and comprehensive (loss) income. For the three
months ended June 30, 2020, we had a net loss of $1,420,236 as
compared to net income of $15,905,290 for the three months ended
June 30, 2019. The change was primarily attributable to an increase
in other expense which was partially offset by a decrease in our
operating expenses. We expect to incur net losses for the
foreseeable future.
For the six
months ended June 30, 2020 and 2019
Operating
expenses. For the six months ended June 30, 2020, our
total operating expenses were $3,431,866 as compared to $3,285,954
for the six months ended June 30, 2019. The increase in operating
expenses was due to the items noted below:
Research and
development. Research and development expenses for the six
months ended June 30, 2020 were $1,228,141, which consisted of
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 six months ended June 30, 2019 were
$1,009,026, which consisted of the upfront payments for the all
fields of use licenses for UM 5050 and UM 8930, 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, Noramco and
ElSohly Laboratories.
For the six months
ended June 30, 2020, research and development expenses increased by
$219,115, as compared to the six months ended June 30, 2019. The
increase is primarily due to an increase in license fees and
salaries.
General and
administrative. General and administrative expenses for the six
months ended June 30, 2020 were $2,203,725, which primarily
consisted of salaries, insurance, 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 six months
ended June 30, 2019 were $2,276,928, 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. General
and administrative expenses remained relatively constant period
over period.
Other expense
(income). For the six months ended June 30, 2020, the
Company had other expense of $328,430 related primarily to interest
expense under the Credit Agreement (as defined below). For the six
months ended June 30, 2019, the Company had other income of
$4,418,452 related primarily to the decrease in fair value of our
derivative liabilities which was driven by the decrease 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. The decrease of $4,746,882
in other income period over period was attributable to the change
in fair value of derivative liabilities from fluctuations in the
Company’s stock price during the period and the quantity of
outstanding instruments underlying the derivative balance. In
December 2019, 40,800,000 of the Emerald Financing Warrants were
exercised which caused a decrease in the overall balance of the
derivative liability. The proceeds from the exercise of the Emerald
Financing Warrants were used to pay down a portion of the Credit
Agreement which also decreased interest expense recognized for the
six months ended June 30, 2020 as compared to the six months ended
June 30, 2019.
Net (loss)
income and comprehensive (loss) income. For the six months
ended June 30, 2020, we had a net loss of $3,761,896 as compared to
net income of $1,130,898 for the six months ended June 30, 2019.
The change to a net loss from net income was primarily attributable
to the increase in other expense and was offset by an increase in
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 June 30, 2020, had an accumulated deficit of
$35,935,178, a stockholders’ deficit of $3,094,424 and a working
capital deficit of $1,929,168. 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 $102,524 as of June 30, 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 to date period. 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 in the
principal amount of $116,700 (the “PPP Loan”) from City National
Bank. The PPP Loan was obtained pursuant to the Paycheck Protection
Program of the Coronavirus Aid, Relief, and Economic Security Act
administered by the U.S. Small Business Administration. We used the
proceeds of the PPP loan for payment of payrolls and rent for our
office space.
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.
During the three months ended June 30, 2020, we received the fourth
and fifth advances of $150,000 and $300,000 pursuant to the Amended
Credit Agreement. The advances bear interest at 7% per annum and
mature on October 5, 2022.
On July 28, 2020, we
filed a registration statement on Form S-1/A, which has been
declared effective as of July 31, 2020, and on July 31, 2020, we
filed a related registration statement on a Form S-1MEF that became
effective under Rule 462(b). On July 31, 2020, we sold 56,333,334
common stock units each consisting of one share of common stock and
one common stock warrant and 60,333,334 pre-funded units each
consisting of one pre-funded warrant and one common stock warrant,
which securities were registered under the foregoing registration
statements under a securities purchase agreement, as reported in
our current report on the Form 8-K filed with the SEC on August 5,
2020. The net proceeds from the transaction were $6.1 million. The
common stock warrants and prefunded warrants have an exercise price
of $0.06 and $0.001, respectively. The term of the common stock
warrants is five years and the pre-funded warrants are exercisable
until all the pre-funded warrants have been exercised in full. We
intend to use the net proceeds of the Offering for general
corporate purposes, including working capital.
During March 2020, we
approved a plan to defer up to 50% of the members of senior
management’s compensation and 100% of the Board of Director and
committee fees indefinitely. In August 2020, subsequent to closing
the August 2020 Financing, our Board of Directors determined that
we have been sufficiently financed and authorized us to pay the
deferred compensation and fee balances together with a retention
bonus of 10% of such balance.
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 connection with 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 June 30, 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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10.3
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Form of Securities Purchase Agreement, dated as of July 31, 2020,
between the Company and certain purchasers set forth in the
signature page thereto (2)
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10.4
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Form of Common Warrant (2)
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10.5
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Form of Pre-Funded Warrant (2)
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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.
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(2)
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Included as exhibit to our Current Report on
Form 8-K filed on August 5, 2020.
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(*) 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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August 13, 2020
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By:
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/s/ Punit
Dhillon
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Punit Dhillon
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Its:
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Chief Executive
Officer, Chairman of the Board, and Director
(Principal Executive Officer)
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August 13, 2020
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By:
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/s/ Elena
Traistaru
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Elena
Traistaru
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Its:
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Chief Financial
Officer
(Principal Financial
and Accounting Officer)
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