GridAI Technologies Corp 10-Q for FY2020 Q3
GridAI Technologies Corp. (GRDX)
10-Q
2020-11-16
For: 2020-09-30
View Original
Added on
April 11, 2026
About this 10-Q
GridAI Technologies Corp filed this 10-Q on November 16, 2020, covering the quarter ended September 30, 2020 (FY2020 Q3).
Headline figures
Quarter ended September 30, 2020, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Net loss
- $5.31M
- compared with a net loss of $4.19M a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the quarterly period ended September 30, 2020
OR
[ ] TRANSITION REPORT
UNDER SECTION 13 OF 15(d) OF THE EXCHANGE ACT OF
1934
From the transition period
from to
Commission File Number 001-37853
AZURRX BIOPHARMA, INC.
(Exact name of small business issuer as specified in its
charter)
|
Delaware
|
|
46-4993860
|
|
(State
or other jurisdiction of incorporation or
organization)
|
|
(IRS
Employer Identification No.)
|
760 Parkside Avenue
Downstate Biotechnology Incubator, Suite 304
Brooklyn, New York 11226
(Address of principal executive offices)
(646) 699-7855
(Issuer’s telephone number)
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 [X] 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 (Sec.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
[X] No [ ]
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,”
“accelerated filer,” “smaller reporting
company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
|
Large accelerated filer
|
[
]
|
Accelerated filer
|
[
]
|
|
Non-accelerated
filer
|
[X]
|
Smaller reporting company
|
[X]
|
|
|
Emerging
growth company
|
[X]
|
|
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 [X]
Securities registered pursuant to Section 12(b) of the
Act:
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which
registered
|
|
Common
Stock, par value $0.0001 per share
|
AZRX
|
Nasdaq
Capital Market
|
As of November 13, 2020, there were 30,412,100 shares of the
registrant’s common stock, $0.0001 par value,
(“Common
Stock”) issued and
outstanding.
TABLE OF CONTENTS
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PART
I
FINANCIAL INFORMATION
ITEM 1. CONSOLIDATED FINANCIAL
STATEMENTS
In our opinion, the accompanying unaudited consolidated financial
statements contain all adjustments (consisting only of normal
recurring adjustments) necessary to present fairly our financial
position, results of operations, and cash flows for the interim
periods presented. We have condensed such financial statements in
accordance with the rules and regulations of the Securities and
Exchange Commission (“SEC”). Therefore, such financial statements do
not include all disclosures required by accounting principles
generally accepted in the United States of America. In preparing
these consolidated financial statements, the Company has evaluated
events and transactions for potential recognition or disclosure
through the date the consolidated financial statements were issued
by filing with the SEC.
These financial statements should be read in conjunction with our
audited financial statements for the year ended December 31, 2019
included in our Annual Report filed on Form 10-K, filed with the
SEC on March 30, 2020.
The results of operations for the three and nine months ended
September 30, 2020 are not necessarily indicative of the results to
be expected for the fiscal year ended December 31,
2020.
AZURRX BIOPHARMA,
INC.
Consolidated Balance Sheets (unaudited)
|
|
September 30,
|
December 31,
|
|
|
2020
|
2019
|
|
ASSETS
|
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
Cash
|
$11,368,680
|
$175,796
|
|
Other
receivables
|
20,688
|
2,637,303
|
|
Prepaid
expenses
|
148,604
|
595,187
|
|
Total
Current Assets
|
11,537,972
|
3,408,286
|
|
|
|
|
|
Property,
equipment, and leasehold improvements, net
|
54,070
|
77,391
|
|
|
|
|
|
Other
Assets:
|
|
|
|
Patents,
net
|
3,011,423
|
3,407,084
|
|
Goodwill
|
1,968,519
|
1,886,686
|
|
Operating
lease right-of-use assets
|
104,196
|
82,386
|
|
Deposits
|
45,841
|
41,047
|
|
Total
Other Assets
|
5,129,979
|
5,417,203
|
|
Total
Assets
|
$16,722,021
|
$8,902,880
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||
|
|
|
|
|
Current
Liabilities:
|
|
|
|
Accounts
payable and accrued expenses
|
$1,686,003
|
$1,754,682
|
|
Accounts
payable and accrued expenses - related party
|
38,453
|
533,428
|
|
Note
payable
|
-
|
444,364
|
|
Accrued
Dividends Payable
|
408,043
|
-
|
|
Convertible
debt
|
-
|
1,076,938
|
|
Other
current liabilities
|
492,815
|
476,224
|
|
Total
Current Liabilities
|
2,625,314
|
4,285,636
|
|
|
|
|
|
Other
liabilities
|
31,469
|
-
|
|
Total
Liabilities
|
2,656,783
|
4,285,636
|
|
|
|
|
|
Stockholders'
Equity:
|
|
|
|
Common
stock - Par value $0.0001 per share; 150,000,000 shares authorized;
28,881,984 and 26,800,519 shares issued and outstanding at
September 30, 2020 and December 31, 2019,
respectively.
|
2,888
|
2,680
|
|
Series
B preferred stock- Par value $0.0001 per share; 5,194.805195 shares
authorized; 2,878.455557 and 0 shares issued and outstanding at
September 30, 2020 and December 31, 2019,
respectively.
|
-
|
-
|
|
Additional
paid-in capital
|
93,239,704
|
68,575,851
|
|
Accumulated
deficit
|
(77,965,806)
|
(62,694,732)
|
|
Accumulated
other comprehensive loss
|
(1,211,548)
|
(1,266,555)
|
|
Total
Stockholders' Equity
|
14,065,238
|
4,617,244
|
|
Total
Liabilities and Stockholders' Equity
|
$16,722,021
|
$8,902,880
|
See accompanying notes to consolidated financial
statements
AZURRX BIOPHARMA,
INC.
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
|
|
Three Months
|
Three Months
|
Nine Months
|
Nine Months
|
|
|
Ended
|
Ended
|
Ended
|
Ended
|
|
|
09/30/20
|
09/30/19
|
09/30/20
|
09/30/19
|
|
|
|
|
|
|
|
Research
and development expenses
|
$1,795,684
|
$2,221,933
|
$4,438,229
|
$7,927,907
|
|
General
and administrative expenses
|
1,916,250
|
1,860,141
|
4,595,860
|
5,690,001
|
|
|
|
|
|
|
|
Loss
from operations
|
(3,711,934)
|
(4,082,074)
|
(9,034,089)
|
(13,617,908)
|
|
|
|
|
|
|
|
Other:
|
|
|
|
|
|
Interest
expense
|
(1,203,404)
|
(110,398)
|
(5,838,417)
|
(278,155)
|
|
Gain
(Loss) on Settlement
|
211,430
|
|
211,430
|
|
|
Gain
(Loss) on Debt Extinguishment
|
(609,998)
|
|
(609,998)
|
|
|
Total
other
|
(1,601,972)
|
(110,398)
|
(6,236,985)
|
(278,155)
|
|
|
|
|
|
|
|
Loss
before income taxes
|
(5,313,906)
|
(4,192,472)
|
(15,271,074)
|
(13,896,063)
|
|
|
|
|
|
|
|
Income
taxes
|
-
|
-
|
-
|
-
|
|
|
|
|
|
|
|
Net
loss
|
(5,313,906)
|
(4,192,472)
|
(15,271,074)
|
(13,896,063)
|
|
|
|
|
|
|
|
Other
comprehensive loss:
|
|
|
|
|
|
Foreign
currency translation adjustment
|
108,712
|
(138,241)
|
(55,007)
|
(207,034)
|
|
Total
comprehensive loss
|
$(5,205,194)
|
$(4,330,713)
|
$(15,326,081)
|
$(14,103,097)
|
|
|
|
|
|
|
|
Net
loss
|
$(5,313,906)
|
$(4,192,472)
|
$(15,271,074)
|
$(13,896,063)
|
|
Deemed
dividend of preferred stock
|
(8,155,212)
|
-
|
(8,155,212)
|
-
|
|
Net
loss applicable to common stockholders
|
(13,469,118)
|
(4,192,472)
|
(23,426,286)
|
(13,896,063)
|
|
|
|
|
|
|
|
Basic
and diluted weighted average shares outstanding
|
28,518,835
|
24,962,691
|
27,828,235
|
21,080,701
|
|
|
|
|
|
|
|
Net
loss per share - basic and diluted
|
$(0.47)
|
$(0.17)
|
$(0.84)
|
$(0.66)
|
See accompanying notes to consolidated financial
statements
AZURRX BIOPHARMA,
INC.
Consolidated Statements of Changes in Stockholders' Equity
(unaudited)
|
|
Convertible
|
|
|
Additional
|
|
Other
|
|
|
|
|
Preferred Stock
|
Common Stock
|
Paid In
|
Accumulated
|
Comprehensive
|
|
||
|
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Loss
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
Balance, January 1, 2019
|
-
|
$-
|
17,704,925
|
$1,771
|
$53,139,259
|
$(47,517,046)
|
$(1,150,112)
|
$4,473,872
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock issued from public offerings
|
|
|
7,522,097
|
752
|
9,491,265
|
|
|
9,492,017
|
|
Common
stock issued to consultants
|
|
|
62,158
|
6
|
112,494
|
|
|
112,500
|
|
Common
stock issued to Mayoly for patents
|
|
|
775,931
|
77
|
1,740,882
|
|
|
1,740,959
|
|
Stock-based
compensation
|
|
|
|
|
541,725
|
|
|
541,725
|
|
Restricted
stock granted to employees/directors
|
|
|
90,000
|
9
|
556,879
|
|
|
556,888
|
|
Warrant
modification
|
|
|
|
|
325,320
|
|
|
325,320
|
|
Received from stockholder in relation to warrant
modification
|
|
|
|
|
61,590
|
|
|
61,590
|
|
Foreign
currency translation adjustment
|
|
|
|
|
|
|
(207,034)
|
(207,034)
|
|
Net
loss
|
|
|
|
|
|
(13,896,063)
|
|
(13,896,063)
|
|
Balance, September 30, 2019
|
-
|
$-
|
26,155,111
|
$2,615
|
$65,969,414
|
$(61,413,109)
|
$(1,357,146)
|
$3,201,774
|
|
|
|
|
|
|
|
|
|
|
Balance, January 1, 2020
|
-
|
$-
|
26,800,519
|
$2,680
|
$68,575,851
|
$(62,694,732)
|
$(1,266,555)
|
$4,617,244
|
|
Issuance
of Series B preferred stock and warrants for cash, conversion of
promissory notes, net of offering costs
|
2,912
|
-
|
|
|
14,460,155
|
|
|
14,460,155
|
|
Warrants
issued in connection with Series B convertible preferred stock
private placement
|
|
|
|
|
5,952,516
|
|
|
5,952,516
|
|
Warrants
issued as inducement to exchange promissory notes into Series B
convertible preferred stock private placement
|
|
|
|
|
986,526
|
|
|
986,526
|
|
Beneficial
conversion feature of Series B preferred stock
|
|
|
|
|
8,155,212
|
|
|
8,155,212
|
|
Deemed
dividend of preferred stock
|
|
|
|
|
(8,155,212)
|
|
|
(8,155,212)
|
|
Accrued
dividends on Series B preferred stock
|
|
|
|
|
(412,829)
|
|
|
(412,829)
|
|
Deemed
dividend related to exchange of promissory notes into Series B
preferred stock
|
|
|
|
|
(1,129,742)
|
|
|
(1,129,742)
|
|
Conversion
of Series B preferred shares into common stock
|
(34)
|
-
|
341,274
|
34
|
(34)
|
|
|
-
|
|
Issuance
of common stock for accrued dividends upon conversion of Series B
preferred stock
|
|
|
6,214
|
1
|
4,785
|
|
|
4,786
|
|
Common
stock issued to settle accounts payable
|
|
|
105,937
|
11
|
131,126
|
|
|
131,137
|
|
Common
stock issued to Lincoln Park for Equity Purchase
agreement
|
|
|
1,495,199
|
149
|
988,199
|
|
|
988,348
|
|
Warrants
issued in association with convertible debt issuance
|
|
|
|
|
1,252,558
|
|
|
1,252,558
|
|
Beneficial
conversion feature on convertible debt issuances
|
|
|
|
|
1,838,422
|
|
|
1,838,422
|
|
Common
stock issued to consultants
|
|
|
132,841
|
13
|
109,592
|
|
|
109,605
|
|
Settlement
with former chief executive officer
|
|
|
|
|
85,770
|
|
|
85,770
|
|
Stock-based
compensation
|
|
|
|
|
396,809
|
|
|
396,809
|
|
Foreign
currency translation adjustment
|
|
|
|
|
-
|
|
55,007
|
55,007
|
|
Net
loss
|
|
|
|
|
|
(15,271,074)
|
|
(15,271,074)
|
|
Balance, September 30, 2020
|
2,878
|
$-
|
28,881,984
|
$2,888
|
$93,239,704
|
$(77,965,806)
|
$(1,211,548)
|
$14,065,238
|
AZURRX BIOPHARMA,
INC.
Consolidated Statements of Cash Flows
(unaudited)
|
|
Nine Months
|
Nine Months
|
|
|
Ended
|
Ended
|
|
|
09/30/20
|
09/30/19
|
|
Cash
flows from operating activities:
|
|
|
|
Net
loss
|
$(15,271,074)
|
$(13,896,063)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
Depreciation
|
26,556
|
51,261
|
|
Amortization
|
395,661
|
825,063
|
|
Non-cash
lease expense
|
(4,855)
|
(3,218)
|
|
Common
stock issued to settle accounts payable for board fees
|
131,137
|
-
|
|
Stock-based
compensation
|
369,517
|
541,725
|
|
Restricted
stock granted to employees/directors
|
27,292
|
556,888
|
|
Common
stock granted to consultants
|
109,605
|
112,500
|
|
Accreted
interest on convertible debt
|
234,334
|
124,932
|
|
Accretion
of debt discount
|
4,580,167
|
147,461
|
|
Loss
on debt extinguishment
|
609,998
|
-
|
|
Gain
on settlement
|
(211,430)
|
-
|
|
Beneficial
conversion feature related to promissory note exchange
|
798,413
|
-
|
|
Changes
in assets and liabilities:
|
|
|
|
Accounts
receivables
|
(220,094)
|
-
|
|
Other
receivables
|
2,121,336
|
(261,981)
|
|
Prepaid
expenses
|
446,766
|
420,218
|
|
Deposits
|
(4,180)
|
(4,125)
|
|
Accounts
payable and accrued expenses
|
90,147
|
601,096
|
|
Accrued
dividends payable
|
408,043
|
-
|
|
Other
liabilities
|
31,104
|
(23,274)
|
|
Net
cash used in operating activities
|
(5,331,557)
|
(10,807,517)
|
|
|
|
|
|
Cash
flows from investing activities:
|
|
|
|
Purchase
of property and equipment
|
(2,808)
|
(17,243)
|
|
Net
cash used in investing activities
|
(2,808)
|
(17,243)
|
|
|
|
|
|
Cash
flows from financing activities:
|
|
|
|
Proceeds
from issuance of notes payable, net
|
179,408
|
-
|
|
Proceeds
from issuance of common stock, net
|
988,348
|
9,492,016
|
|
Proceeds
from issuance of convertible debt, net
|
3,227,002
|
2,000,000
|
|
Proceeds
from issuance of preferred stock, net
|
13,197,740
|
-
|
|
Received
from stockholder in relation to warrant modification
|
-
|
61,590
|
|
Repayments
of convertible debt
|
(475,000)
|
-
|
|
Repayments
of note payable
|
(623,772)
|
(255,032)
|
|
Net
cash provided by financing activities
|
16,493,726
|
11,298,574
|
|
|
|
|
|
Increase
in cash
|
11,159,361
|
473,814
|
|
|
|
|
|
Effect
of exchange rate changes on cash
|
33,523
|
(38,332)
|
|
|
|
|
|
Cash,
beginning balance
|
175,796
|
1,114,343
|
|
|
|
|
|
Cash,
ending balance
|
$11,368,680
|
$1,549,825
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosures of cash flow information:
|
|
|
|
Cash
paid for interest
|
$105,460
|
$5,762
|
|
|
|
|
|
Non-cash
investing and financing activities:
|
|
|
|
|
|
|
|
Common
stock issued for patents purchased from Mayoly
|
$-
|
$1,740,959
|
|
Warrant
modification related to convertible debt issuance
|
$-
|
$325,320
|
|
Deemed
dividend on preferred stock
|
$8,155,212
|
$-
|
|
Accrued
dividends on preferred stock
|
$408,043
|
$-
|
|
Exchange
of promissory notes into preferred stock and warrants
|
$609,998
|
$-
|
See accompanying notes to consolidated financial
statements
Note 1 - The Company
and Basis of Presentation
Description of Business
AzurRx BioPharma, Inc. (“AzurRx” or “Parent”) was incorporated on January 30, 2014 in
the State of Delaware. In June 2014, AzurRx acquired 100% of the
issued and outstanding capital stock of AzurRx SAS (formerly,
ProteaBio Europe SAS), a company incorporated in October 2008 under
the laws of France. AzurRx and its wholly-owned subsidiary, AzurRx
SAS (“ABS”), are collectively referred to as the
“Company.”
The Company is engaged in the research and development of
non-systemic biologics for the treatment of patients with
gastrointestinal disorders. Non-systemic biologics are
non-absorbable drugs that act locally, i.e. the intestinal lumen,
skin or mucosa, without reaching an individual’s systemic
circulation.
The Company is currently focused on developing its lead drug
candidate, MS1819, a yeast derived recombinant lipase for
the treatment of exocrine pancreatic insufficiency
(“EPI”)
associated with cystic fibrosis (“CF”) and chronic pancreatitis
(“CP”).
MS1819, supplied as an oral
non-systemic biologic capsule, is derived from
the Yarrowia
lipolytica yeast lipase
and breaks up fat molecules in the digestive tract of EPI patients
so that they can be absorbed as nutrients. Unlike the standard of
care, the MS1819 synthetic lipase does not contain any animal
products.
The
Company is currently conducting two
Phase 2 clinical trials of MS1819: the OPTION 2 monotherapy trial
in the U.S. and Europe, and the Combination therapy trial in
Europe, consisting of MS1819 in conjunction with porcine-derived
pancreatic enzyme replacement therapy, the current standard of
care.
Basis of Presentation and Principles of Consolidation
The accompanying unaudited interim consolidated financial
statements have been prepared in accordance with accounting
principles generally accepted in the United States of America
(“U.S. GAAP”). In our opinion, the accompanying
unaudited interim consolidated financial statements include all
adjustments, consisting of normal recurring adjustments, which are
necessary to present fairly our financial position, results of
operations, and cash flows. The consolidated balance sheet at
December 31, 2019, has been derived from audited financial
statements of that date. The unaudited interim consolidated results
of operations are not necessarily indicative of the results that
may occur for the full fiscal year. Certain information and
footnote disclosure normally included in financial statements
prepared in accordance with U.S. GAAP have been omitted pursuant to
instructions, rules, and regulations prescribed by the Securities
and Exchange Commission (“SEC”).
The Company believes that the disclosures provided herein are
adequate to make the information presented not misleading when
these unaudited interim consolidated financial statements are read
in conjunction with the audited financial statements and notes
previously distributed in our Annual Report Form 10-K for the year
ended December 31, 2019, filed with the SEC on March 30,
2020.
The
unaudited interim consolidated financial statements include the
accounts of AzurRx and its wholly-owned subsidiary, AzurRx SAS.
Intercompany transactions and balances have been eliminated upon
consolidation.
Going Concern Uncertainty
The accompanying unaudited interim consolidated financial
statements have been prepared as if the Company will continue as a
going concern. The Company has incurred significant operating
losses and negative cash flows from operations since inception and
had an accumulated deficit of approximately $78.0 million at
September 30, 2020. The Company is dependent on obtaining, and
continues to pursue, additional working capital funding from the
sale of securities and debt in order to continue to execute its
development plan and continue operations. Without adequate working
capital, the Company may not be able to meet its obligations and
continue as a going concern. These conditions raise substantial
doubt about our ability to continue as a going concern. The
financial statements do not include any adjustments that
might result from the outcome of this uncertainty.
Our primary sources of liquidity come from capital raises
through additional equity and/or debt financings. This may be impacted by the novel
coronavirus ("COVID-19")
pandemic, which is evolving and could
negatively impact our ability to raise additional capital in the
future.
Note 2 - Significant Accounting Policies and Recent Accounting
Pronouncements
Use of Estimates
The
accompanying unaudited consolidated financial statements are
prepared in conformity with U.S. GAAP and include certain estimates
and assumptions which affect the reported amounts of assets and
liabilities at the date of the financial statements (including
goodwill, intangible assets and contingent consideration), and the
reported amounts of revenues and expenses during the reporting
period, including contingencies. Accordingly, actual results may
differ from those estimates.
Cash and Cash Equivalents
The
Company considers all highly liquid investments with maturities of
three months or less from date of purchase to be cash equivalents.
All cash balances were highly liquid at September 30, 2020 and
December 31, 2019, respectively.
Concentrations of Credit Risk
Financial
instruments that potentially expose the Company to concentrations
of credit risk consist of cash. The Company primarily maintains its
cash balances with financial institutions in federally insured
accounts in the U.S. The Company may from time to time have cash in
banks in excess of FDIC insurance limits. At September 30, 2020 and
December 31, 2019, the Company had approximately $11.1 million and
$0, respectively, in one account in the U.S. in excess of these
limits. The Company has not experienced any losses to date
resulting from this practice. The Company mitigates its risk by
maintaining the majority of its cash and cash equivalents with high
quality financial institutions.
The
Company also has exposure to foreign currency risk as its
subsidiary in France has a functional currency in
Euros.
Debt Instruments
Detachable warrants issued in conjunction with debt are measured at
their relative fair value, if they are determined to be equity
instrument, or their fair value, if they are determined to be
liability instruments, and recorded as a debt
discount. Conversion features that are in the money at
the commitment date constitute a beneficial conversion feature that
is measured at its intrinsic value and recognized as debt discount.
Debt discount is amortized as interest expense over the maturity
period of the debt using the effective interest method. Contingent
beneficial conversion features are recognized when the contingency
has been resolved.
Debt Issuance Costs
Debt issuance costs are recorded as a direct reduction of the
carrying amount of the related debt. Debt issuance costs are
amortized over the maturity period of the related debt instrument
using the effective interest method.
Equity-Based Payments to Non-Employees
Equity-based
payments to non-employees are measured at fair value on the grant
date per ASU No. 2018-07, Improvements to Nonemployee Share-Based
Payment Accounting.
Fair Value Measurements
The
Company follows Accounting Standards Codification (“ASC”) Topic 820-10, Fair
Value Measurements and Disclosures (“ASC 820”), which among
other things, defines fair value, establishes a consistent
framework for measuring fair value and expands disclosure for each
major asset and liability category measured at fair value on either
a recurring or nonrecurring basis. Fair value is an exit price,
representing the amount that would be received to sell an asset or
paid to transfer a liability in an orderly transaction between
market participants. As such, fair value is a market-based
measurement that should be determined based on assumptions that
market participants would use in pricing an asset or
liability.
As a
basis for considering such assumptions, a three-tier fair value
hierarchy has been established, which prioritizes the inputs used
in measuring fair value as follows:
Level
1: Observable inputs such as quoted prices (unadjusted) in active
markets for identical assets or liabilities;
Level
2: Inputs, other than the quoted prices in active markets, that are
observable either directly or indirectly; and
Level
3: Unobservable inputs in which there is little or no market data,
which require the reporting entity to develop its own assumptions,
which reflect those that a market participant would
use.
In
certain cases, the inputs used to measure fair value may fall into
different levels of the fair value hierarchy. In such cases, an
instrument’s level within the fair value hierarchy is based
on the lowest level of input that is significant to the overall
fair value measurement. The Company’s assessment of the
significance of a particular input to the fair value measurement in
its entirety requires judgment and considers factors specific to
the financial instrument.
The
Company recognizes transfers between levels as if the transfers
occurred on the last day of the reporting period.
Foreign Currency Translation
For
foreign subsidiaries with operations denominated in a foreign
currency, assets and liabilities are translated to U.S. dollars,
which is the functional currency, at period end exchange rates.
Income and expense items are translated at average rates of
exchange prevailing during the periods presented. Gains and losses
from translation adjustments are accumulated in a separate
component of stockholders’ equity.
Goodwill and Intangible Assets
Goodwill
represents the excess of the purchase price of the acquired
business over the fair value of amounts assigned to assets acquired
and liabilities assumed. Goodwill and other intangible assets with
indefinite useful lives are reviewed for impairment annually or
more frequently if events or circumstances indicate impairment may
be present. Any excess in carrying value over the estimated fair
value is charged to results of operations. The Company has not
recognized any impairment charges through September 30,
2020.
Intangible assets subject to amortization consist of in process
research and development, license agreements, and patents reported
at the fair value at date of the acquisition less accumulated
amortization. Amortization expense is provided using the
straight-line method over the estimated useful lives of the assets
as follows:
Patents
7.2 years
In
Process Research &
Development
12 years
License
Agreements
5 years
Impairment of Long-Lived Assets
The
Company periodically evaluates its long-lived assets for potential
impairment in accordance with ASC Topic 360, Property, Plant and
Equipment (“ASC
360”). Potential impairment is assessed when there is
evidence that events or changes in circumstances indicate that the
carrying amount of an asset may not be recovered. Recoverability of
these assets is assessed based on undiscounted expected future cash
flows from the assets, considering a number of factors, including
past operating results, budgets and economic projections, market
trends and product development cycles. If impairments are
identified, assets are written down to their estimated fair value.
The Company has not recognized any impairment charges through
September 30, 2020.
Income Taxes
Income
taxes are recorded in accordance with ASC 740, Accounting for
Income Taxes (“ASC
740”), which provides for deferred taxes using an
asset and liability approach. The Company recognizes deferred tax
assets and liabilities for the expected future tax consequences of
events that have been included in the financial statements or tax
returns. The Company determines its deferred tax assets and
liabilities based on differences between financial reporting and
tax bases of assets and liabilities, which are measured using the
enacted tax rates and laws that will be in effect when the
differences are expected to reverse. Valuation allowances are
provided if, based upon the weight of available evidence, it is
more likely than not that some or all of the deferred tax assets
will not be realized.
The
Company accounts for uncertain tax positions in accordance with the
provisions of ASC 740. When uncertain tax positions exist, the
Company recognizes the tax benefit of tax positions to the extent
that the benefit will more likely than not be realized. The
determination as to whether the tax benefit will more likely than
not be realized is based upon the technical merits of the tax
position as well as consideration of the available facts and
circumstances. At September 30, 2020 and December 31, 2019, the
Company does not have any significant uncertain tax positions. All
tax years are still open for audit.
Leases
Effective
January 1, 2019, the Company adopted Accounting Standards Update
(“ASU”) No.
2016-02, “Leases.” This ASU requires substantially all
leases be recorded on the balance sheet as right of use assets and
lease obligations. The Company adopted the ASU using a modified
retrospective adoption method at January 1, 2019, as outlined in
ASU No. 2018-11, “Leases - Targeted Improvements.”
Under this method of adoption, there is no impact to the
comparative condensed consolidated statements of operations and
condensed consolidated balance sheets. The Company determined that
there was no cumulative-effect adjustment to beginning retained
earnings on the consolidated balance sheet. In addition, the
Company elected the package of practical expedients permitted under
the transition guidance within the new standard, which among other
things, allowed carryforward of historical lease classifications.
Adoption of this standard did not materially impact the
Company’s results of operations and had no impact on the
consolidated statements of cash flows.
Research and Development
Research
and development (“R&D”) costs are charged to
operations when incurred and are included in operating expense.
R&D costs consist principally of compensation of employees and
consultants that perform the Company’s research and
development and clinical activities, the fees paid to maintain the
Company’s licenses, and the payments to third parties for
manufacturing drug supply and clinical trials, laboratory and other
supply expenses and amortization of intangible assets.
Stock-Based Compensation
The
Company’s board of directors (the “Board”) and stockholders have
adopted and approved the Amended and Restated 2014 Omnibus Equity
Incentive Plan (the “2014
Plan”) which took effect on May 12, 2014, and the 2020
Omnibus Equity Incentive Plan, which took effect on September 11,
2020 (the “2020
Plan”). From the effective date of the 2020 Plan, no
new awards have been or will be made under the 2014 Plan. The
Company accounts for its stock-based compensation awards to
employees and Board members in accordance with ASC Topic 718,
Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all
stock-based payments to employees and Board members, including
grants of employee stock options, to be recognized in the
statements of operations by measuring the fair value of the award
on the date of grant and recognizing this fair value as stock-based
compensation using a straight-line method over the requisite
service period, generally the vesting period.
For
awards with performance conditions that affect their vesting, such
as the occurrence of certain transactions or the achievement of
certain operating or financial milestones, recognition of fair
value of the award occurs when vesting becomes
probable.
The
Company estimates the grant date fair value of stock option awards
using the Black-Scholes option-pricing model. The use of the
Black-Scholes option-pricing model requires management to make
assumptions with respect to the expected term of the option, the
expected volatility of the Common Stock consistent with the
expected life of the option, risk-free interest rates and expected
dividend yields of the Common Stock.
Sublicense Agreement
As more
fully discussed in Note 14, the Company entered into a sublicense
agreement with TransChem, Inc. (“TransChem”), pursuant to which
TransChem granted the Company an exclusive license to certain
patents and patent applications. Any payments made to TransChem in
connection with this sublicense agreement are recorded as R&D
expense.
Subsequent Events
The
Company considered events or transactions occurring after the
balance sheet date but prior to the date the consolidated financial
statements are available to be issued for potential recognition or
disclosure in its consolidated financial statements.
Recent Accounting Pronouncements
In
January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill
and Other, Simplifying the Accounting for Goodwill Impairment. ASU
2017-04 removes Step 2 of the goodwill impairment test, which
requires a hypothetical purchase price allocation. A goodwill
impairment will now be the amount by which a reporting unit’s
carrying value exceeds its fair value, not to exceed the carrying
amount of goodwill. All other goodwill impairment guidance will
remain largely unchanged. Entities will continue to have the option
to perform a qualitative assessment to determine if a quantitative
impairment test is necessary. This new guidance will be applied
prospectively and is effective for annual or any interim goodwill
impairment tests in fiscal years beginning after December 15, 2019.
This ASU, which the Company adopted as of January 1, 2020, did not
have a material effect on the Company’s consolidated
financial statements.
In
August 2020, the Financial Accounting Standards Board
(“FASB”) issued an accounting pronouncement (ASU
2020-06) related to the measurement and disclosure requirements for
convertible instruments and contracts in an entity's own equity.
The pronouncement simplifies and adds disclosure requirements for
the accounting and measurement of convertible instruments and the
settlement assessment for contracts in an entity's own equity. As a
smaller reporting company, as defined by the SEC, this
pronouncement is effective for fiscal years, and for interim
periods within those fiscal years, beginning after December 15,
2023. The Company is currently evaluating the impact of this ASU on
the financial statements.
Note 3 - Fair Value
Disclosures
Fair
value is the price that would be received from the sale of an asset
or paid to transfer a liability assuming an orderly transaction in
the most advantageous market at the measurement date. U.S. GAAP
establishes a hierarchical disclosure framework that prioritizes
and ranks the level of observability of inputs used in measuring
fair value.
The
fair value of the Company's financial instruments are as
follows:
|
|
|
Fair Value Measured a
Reporting Date Using
|
|
||
|
|
Carrying Amount
|
Level 1
|
Level 2
|
Level 3
|
Fair Value
|
|
At
September 30, 2020:
|
|
|
|
|
|
|
Cash
|
$11,368,680
|
$
|
$11,368,680
|
$
|
$11,368,680
|
|
Other
receivables
|
$20,688
|
|
$
|
$20,688
|
$20,688
|
|
|
|
|
|
|
|
|
At
December 31, 2019:
|
|
|
|
|
|
|
Cash
|
$175,796
|
$-
|
$175,796
|
$-
|
$175,796
|
|
Other
receivables
|
$2,637,303
|
$-
|
$-
|
$2,637,303
|
$2,637,303
|
|
Note
payable
|
$444,364
|
$-
|
$-
|
$444,364
|
$444,364
|
|
Convertible
debt
|
$1,076,938
|
$-
|
$-
|
$1,076,938
|
$1,076,938
|
At
September 30, 2020, the fair
value of other receivables approximates carrying value as these
consist primarily of refundable tax credits.
At
December 31, 2019, the fair value of other receivables approximates
carrying value as these consist primarily of French R&D tax
credits that are normally received the following year.
The
fair value of the note payable in connection with the financing of
directors and officer’s liability insurance approximates
carrying value due to the terms of such instruments and applicable
interest rates.
The
convertible debt is based on its fair value less unamortized debt
discount plus accrued interest through the date of reporting (see
Note 9).
Note 4 - Other Receivables
Other
receivables consisted of the following:
|
|
September 30,
|
December 31,
|
|
|
2020
|
2019
|
|
R&D
tax credits
|
$-
|
$2,566,281
|
|
Other
|
20,688
|
71,022
|
|
Total
other receivables
|
$20,688
|
$2,637,303
|
At
September 30, 2020, the R&D
tax credits were comprised of a portion of the 2019 refundable tax
credits for research conducted in France.
At
December 31, 2019, the R&D tax credits were comprised of the
2017, 2018, and 2019 refundable tax credits for research conducted
in France. In the nine months ended September 30, 2020, the Company received
both the 2017 and 2018 and partial 2019 refundable tax credits
totaling approximately $2,289,096. At December 31, 2019, Other
consisted of amounts due from U.S. R&D tax
credits.
Note 5 - Property, Equipment and Leasehold
Improvements
Property,
equipment and leasehold improvements consisted of the
following:
|
|
September 30,
|
December 31,
|
|
|
2020
|
2019
|
|
Laboratory
equipment
|
$193,661
|
$193,661
|
|
Computer
equipment
|
77,850
|
74,836
|
|
Office
equipment
|
36,703
|
36,703
|
|
Leasehold
improvements
|
29,162
|
35,711
|
|
Total
property, plant and equipment
|
337,376
|
340,911
|
|
Less
accumulated depreciation
|
(283,306)
|
(263,520)
|
|
Property,
plant and equipment, net
|
$54,070
|
$77,391
|
Depreciation
expense for the three months ended September 30, 2020 and 2019 was
$8,188 and $17,220, respectively. Depreciation expense for the nine
months ended September 30, 2020
and 2019 was $26,556 and $51,261, respectively.
For the
three months ended September 30, 2020, $4,881 of depreciation is
included in R&D expense and $3,307 of depreciation is included
in G&A expense. For the nine months ended September 30, 2020,
$14,372 of depreciation is included in R&D expense and $12,184
of depreciation is included in G&A expense.
For the
three months ended September 30, 2019, $11,842 of depreciation has
been reclassified to R&D expense and $5,149 of depreciation
remains in G&A expense. For the nine months ended September 30,
2019, $35,442 of depreciation is included in R&D expense and
$15,343 of depreciation is included in G&A
expense.
Note 6 - Intangible Assets and Goodwill
Patents
Pursuant
to the Mayoly APA entered into on March 27, 2019, in which the
Company purchased all rights, title and interest in and to MS1819
(see Note 14), the Company recorded Patents in the amount of
$3,802,745 as follows:
|
Common
stock issued at signing to Mayoly
|
$1,740,959
|
|
Due
to Mayoly at 12/31/19 - €400,000
|
449,280
|
|
Due
to Mayoly at 12/31/20 - €350,000
|
393,120
|
|
Assumed
Mayoly liabilities and forgiveness of Mayoly debt
|
1,219,386
|
|
|
$3,802,745
|
Intangible
assets are as follows:
|
|
September 30,
|
December 31,
|
|
|
2020
|
2019
|
|
Patents
|
$3,802,745
|
$3,802,745
|
|
Less
accumulated amortization
|
(791,322)
|
(395,661)
|
|
Patents,
net
|
$3,011,423
|
$3,407,084
|
Amortization
expense for the three months ended September 30, 2020 and 2019 was
$131,887 and $131,887, respectively. Amortization expense for the
nine months ended September 30, 2020 and 2019 was $395,661 and
$825,063, respectively.
Amortization
expense for the nine months ended September 30, 2019 included
$384,234 from In process
research and development and License agreements written off as a
result of the Mayoly APA.
As of
September 30, 2020, amortization expense related to patents is
expected to be as follows for the next five years (2020 through
2025):
|
2020
(balance of year)
|
$395,661
|
|
2021
|
527,548
|
|
2022
|
527,548
|
|
2023
|
527,548
|
|
2024
|
527,548
|
|
2025
|
527,548
|
Goodwill is as follows:
|
|
Goodwill
|
|
Balance
at January 1, 2019
|
$1,924,830
|
|
Foreign
currency translation
|
(38,144)
|
|
Balance
at December 31, 2019
|
1,886,686
|
|
Foreign
currency translation
|
81,833
|
|
Balance
at September 30, 2020
|
$1,968,519
|
Note 7 - Accounts Payable and Accrued Expenses
Accounts
payable and accrued expenses consisted of the
following:
|
|
September 30,
|
December 31,
|
|
|
2020
|
2019
|
|
Trade
payables
|
$1,422,066
|
$1,683,505
|
|
Accrued
expenses
|
263,937
|
71,177
|
|
Total
accounts payable and accrued expenses
|
$1,686,003
|
$1,754,682
|
At
September 30, 2020, and December 31, 2019, trade payables included
$0, and $1,683,505, respectively, due to related
parties.
Note 8 - Notes Payable
Directors and Officer’s Liability Insurance
On
December 5, 2019, the Company entered into a 9-month financing
agreement for its directors and officer’s liability insurance
in the amount of $498,783 that bears interest at an annual rate of
5.461%. Monthly payments, including principal and interest, are
$56,689 per month. The balance due under this financing agreement
at September 30, 2020 was $0.
CARES ACT PPP Loan
In
April 2020, the Company applied for and received a CARES Act Paycheck Protection Program
(“PPP”) loan of $179,418 through the Small Business
Administration (SBA). In May 2020, the Company returned the loan of
$179,418 after analysis of the updated guidance from the
U.S. Department of Treasury and the SBA regarding the eligibility
for such loans.
Note 9 – Convertible Notes
ADEC Notes
On
February 14, 2019, the Company entered into a Note Purchase
Agreement (the “ADEC
NPA”) with ADEC Private Equity Investments, LLC
(“ADEC”),
pursuant to which the Company issued to ADEC two Senior Convertible
Notes (“Note A”
and “Note B,”
respectively, each an “ADEC
Note,” and together, the “ADEC Notes”), in the
principal amount of $1,000,000 per ADEC Note, resulting in gross
proceeds to the Company of $2,000,000 (the “ADEC Note Offering”). ADEC is
controlled by a significant stockholder of the
Company.
The
ADEC Notes accrued interest at a rate of 10% per annum; provided,
however, that in the event the Company should elect to repay the
full balance due under the terms of both ADEC Notes prior to
December 31, 2019, then the interest rate would be reduced to 6%
per annum. Interest would be payable at the time all outstanding
principal amounts owed under each ADEC Note were repaid. The ADEC
Notes were scheduled to mature on the earlier to occur of (i) the
tenth business day following the receipt by ABS of certain tax
credits that the Company expects to receive prior to July 2019 in
the case of Note A (the “2019 Tax Credit”) and July
2020 in the case of Note B (the “2020 Tax Credit”),
respectively, or (ii) December 31, 2019 in the case of Note A and
December 31, 2020 in the Case of Note B (the “Maturity Dates”). As a
condition to entering into the ADEC NPA, ABS and ADEC also entered
into a Pledge Agreement, pursuant to which ABS agreed to pledge an
interest in each of the 2019 Tax Credit and 2020 Tax Credit to ADEC
in order to guarantee payment of all amounts due under the terms of
the ADEC Notes.
Each of
the ADEC Notes was convertible, at ADEC’s option, into shares
of Common Stock, at a conversion price equal to $2.50 per share;
provided, however, that pursuant to the term of the ADEC Notes,
ADEC could not convert all or a portion of the ADEC Notes if such
conversion would result in the significant stockholder and/or
entities affiliated with him beneficially owning in excess of
19.99% of the shares of Common Stock issued and outstanding
immediately after giving effect to the issuance of the shares
issuable upon conversion of the ADEC Notes (the “ADEC Note Conversion
Shares”).
As
additional consideration for entering into the ADEC NPA, the
Company entered into a warrant amendment agreement, whereby the
Company agreed to reduce the exercise price of 1,009,565
outstanding warrants previously issued by the Company to ADEC and
its affiliates (the “ADEC
Warrants”) to $1.50 per share (the “ADEC Warrant Amendment”). The
ADEC Warrant Amendment did not alter any other terms of the ADEC
Warrants. The ADEC Warrant Amendment resulted in a debt discount of
$325,320 that was accreted to additional interest expense over the
lives of the ADEC Notes.
In
December 2019, the Company repaid $1,550,000 principal amount of
the ADEC Notes and on January 2, 2020 repaid the remaining
principal balance of $450,000 plus outstanding accrued interest of
$104,153. As of September 30, 2020, no ADEC Notes were
outstanding.
Senior Convertible Promissory Note Offering
On
December 20, 2019, the Company began an offering of (i) Senior
Convertible Promissory Notes (each a “Promissory Note,” and together,
the “Promissory
Notes”) in the principal amount of up to $8.0 million
to certain accredited investors (the “Note Investors”), and (ii)
warrants (“Note
Warrants”) to purchase shares of Common Stock, each
pursuant to Note Purchase Agreements entered into by and between
the Company and each of the Note Investors (the “Promissory NPAs”) (the
“Promissory Note
Offering”).
In
December 2019, the Company issued Promissory Notes to the Note
Investors in the aggregate principal amount of $3,386,300. The
Promissory Notes were scheduled to mature on September 20, 2020,
accrue interest at a rate of 9% per annum, and were convertible, at
the sole option of the holder, into shares of Common Stock (the
“Promissory Note Conversion
Shares”) at a price of $0.97 per share (the
“Conversion
Option”). The Promissory Notes could be prepaid by the
Company at any time prior to the maturity date in cash without
penalty or premium (the “Prepayment Option”).
On
January 2, 2020, January 3, 2020, and January 9, 2020, the Company
issued Promissory Notes to the Note Investors in the aggregate
principal amount of $3,517,700.
As
additional consideration for the execution of the Promissory NPA,
each Note Investor also received Note Warrants to purchase that
number of shares of Common Stock equal to one-half (50%) of the
Promissory Note Conversion Shares issuable upon conversion of the
Promissory Notes (the “Note Warrant Shares”). The Note
Warrants have an exercise price of $1.07 per share and expire five
years from the date of issuance. In addition, all of the Note
Warrants, other than those issued in the December 20, 2019 closing
(covering an aggregate of 2,374,345 shares of Common Stock) contain
a provision prohibiting exercise until the expiration of six months
from the date of issuance. The Company and each Note Investor
executed a Registration Rights Agreement (the “RRA”), pursuant to which the
Company agreed to file a registration statement. The Company filed
a registration statement with the SEC on February 7, 2020 covering
the Promissory Note Conversion Shares and Note Warrant Shares, but
that registration statement was not declared effective and was
subsequently withdrawn by the Company. On July 27, 2020, the
Company filed a separate registration statement in connection with
the Series B Private Placement and the Exchange described in Note
11, which also covers the Note Warrant Shares. That registration
statement was declared effective on September 21,
2020.
In
connection with the four closings in December 2019 of the
Promissory Note
Offering, the Company paid aggregate placement agent fees of
$338,630, which fees were based on (i) 9% of the aggregate
principal amount of the Promissory Notes issued to the Note
Investors introduced by the placement agent, and (ii) a
non-accountable expense allowance of 1% of the gross proceeds from
the Promissory Note
Offering. In addition, the placement agent was issued warrants,
containing substantially the same terms and conditions as the Note
Warrants, to purchase an aggregate of 244,372 shares of Common
Stock (the “January
Placement Agent Warrants”), representing 7% of the
Promissory Note Conversion Shares issuable upon conversion of the
Promissory Notes issued to the Note Investors. The January
Placement Agent Warrants expire five years from the date of
issuance. The January Placement Agent Warrants in connection with
the December 2019 closings have an exercise price of $1.21 per
share.
In
connection with the three closings in January 2020 of the
Promissory Note
Offering, the Company paid aggregate placement agent fees of
$276,770, which fees were based on (i) 9% of the aggregate
principal amount of the Promissory Notes issued to the Note
Investors introduced by the placement agent, and (ii) a
non-accountable expense allowance of 1% of the gross proceeds from
the Promissory Note
Offering. In addition, the placement agent was issued January
Placement Agent Warrants, to purchase an aggregate of 199,732
shares of Common Stock. 41,495 of these January Placement Agent
Warrants have an exercise price of $1.21 per share and 158,237 of
these January Placement Agent Warrants have an exercise price of
$1.42 per share.
The
Company determined the Prepayment Option feature represents a
contingent call option. The Company evaluated the Prepayment Option
in accordance with ASC 815-15-25. The Company determined that the
Prepayment Option feature is clearly and closely related to the
debt host instrument and is not an embedded derivative requiring
bifurcation. Additionally, the Company determined the Conversion
Option represents an embedded call option. The Company evaluated
the Conversion Option in accordance with ASC 815-15-25. The Company
determined that the Conversion Option feature meets the scope
exception from ASC 815 and is not an embedded derivative requiring
bifurcation.
The
Company evaluated the Promissory Notes for a beneficial conversion
feature in accordance with ASC 470-20. The Company determined that
at each commitment date the effective conversion price was below
the closing stock price (market value), and the Convertible Notes
contained a beneficial conversion feature.
Pursuant
to the December 2019 closings of the Promissory Note Offering, the
principal amount of $3,386,300 was first allocated based on the
relative fair value of the Promissory Notes and the Note Warrants.
The fair value of the Note Warrants amounted to $912,648. Then the
beneficial conversion feature was calculated, which amounted to
$1,359,284. The Company incurred debt issuance costs of $588,017
related to the offering. The initial carrying value of the
Promissory Notes issued amounted to $526,351.
Pursuant
to the January 2020 closings of the Promissory Note Offering, the
principal amount of $3,517,700 was first allocated based on the
relative fair value of the Promissory Notes and the Note Warrants.
The fair value of the Note Warrants amounted to $2,439,272. Then
the beneficial conversion feature was calculated, which amounted to
$1,838,422. The Company incurred debt issuance costs of $472,326
related to the offering. The initial carrying value of the
Promissory Notes issued amounted to $128,524.
On June
1, 2020, the Company entered into an amendment to a certain
Promissory Note in the principal amount of $100,000 issued on
December 20, 2019 to Edward J. Borkowski, the chairman of the
Board, to increase the Conversion Price to $1.07 per share (the
“Note
Amendment”). The Company
evaluated the Note Amendment transaction in accordance with ASC
470-50 and determined the Note Amendment did not constitute a
substantive modification of the Promissory Note and that the
transaction should be accounted for as a debt modification with no
accounting treatment required.
During
the three months ended September 30, 2020, the Company recognized
$404,222 of interest expense related to these Promissory Notes,
including amortization of debt discount related to the value of the
Note Warrants of $120,165, amortization of the beneficial
conversion feature of $193,555, amortization of debt discount
related to debt issuance costs of $63,264, and accrued interest
expense of $27,238.
During
the nine months ended September 30, 2020, the Company recognized
$4,912,396 of interest expense related to these Promissory Notes,
including amortization of debt discount related to the value of the
Note Warrants of $1,461,728, amortization of the beneficial
conversion feature of $2,347,763, amortization of debt discount
related to debt issuance costs of $771,675, and accrued interest
expense of $332,230.
Exchange of Promissory Notes into Series B Convertible Preferred
Stock
As more
fully discussed in Note 11, on July 16, 2020, in connection with
the Series B Private Placement, 937.004177 shares of Series B
Preferred Stock, Series B Warrants to purchase 4,684,991 shares of
Common Stock, and Exchange Warrants to purchase 1,772,937 shares of
Common Stock were issued to certain holders of the Promissory Notes
in exchange for such Promissory Notes for aggregate consideration
of approximately $7.2 million consisting of approximately $6.9
million aggregate outstanding principal amount, together with
accrued and unpaid interest thereon through the date of the Series
B Private Placement of approximately $0.3 million.
The
Company prepaid the remaining outstanding balance of $25,000
aggregate principal amount of Promissory Notes, together with
accrued and unpaid interest thereon through the prepayment date of
$1,307, held by those holders who did not participate in the
Exchange. Following these transactions, no Promissory Notes remain
outstanding.
Accounting for the Exchange of Promissory Notes into Series B
Private Placement
The Company determined the Exchange of the Promissory Notes into
Series B Preferred Stock and related warrants should be recognized
as an extinguishment of the Promissory Notes, which resulted in a
loss on extinguishment of approximately $0.6
million. Additionally, the Company recorded interest expense
of approximately $0.8 million related to the remaining unamortized
discount resulting from initial beneficial conversion feature of
the Promissory Notes on closing date of the
Exchange.
Convertible
Debt consisted of:
|
|
Total
|
Promissory Notes
|
ADEC Notes
|
Total
|
|
|
September 30,
|
September 30,
|
September 30,
|
December 31,
|
|
|
2020
|
2020
|
2020
|
2019
|
|
Convertible
debt
|
$-
|
$-
|
$-
|
$3,836,300
|
|
Unamortized
debt discount - revalued warrants
|
-
|
-
|
-
|
(118,356)
|
|
Unamortized
debt discount - warrants
|
-
|
-
|
-
|
(878,979)
|
|
Unamortized
debt discount - BCF
|
-
|
-
|
-
|
(1,307,755)
|
|
Unamortized
debt discount - debt issuance costs
|
-
|
-
|
-
|
(566,815)
|
|
Accrued
interest
|
-
|
-
|
-
|
112,543
|
|
Total
convertible debt
|
$-
|
$-
|
$-
|
$1,076,938
|
Note 10 – Other Liabilities
Other
liabilities consisted of the following:
|
|
September 30,
|
December 31,
|
|
Current
|
2020
|
2019
|
|
Due
to Mayoly
|
$410,026
|
$392,989
|
|
Lease
liabilities
|
74,156
|
83,235
|
|
Other
liabilities
|
8,633
|
-
|
|
|
$492,815
|
$476,224
|
|
|
|
|
|
|
September 30,
|
December 31,
|
|
Long-term
|
2020
|
2019
|
|
Lease
liabilities
|
31,469
|
-
|
|
|
$31,469
|
$-
|
Note 11 – Equity
Our certificate
of incorporation, as amended and restated on December 20, 2019 (the
“Charter”)
authorizes the issuance of up to 150,000,000 shares of Common
Stock, par value $0.0001 per share, and 10,000,000 shares of
preferred stock, par value $0.0001 per share.
On
December 19, 2019, the Company held its Annual Meeting of
Stockholders (the “2019
Annual Meeting”), whereby, the shareholders approved,
among others, amending the Company’s Charter to authorize the
Board to effect a reverse stock split of both the issued and
outstanding and authorized shares of Common Stock, at a specific
ratio, ranging from one-for-two (1:2) to one-for-five (1:5), any
time prior to the one-year anniversary date of the 2019 Annual
Meeting, with the exact ratio to be determined by the Board (the
“Reverse
Split”). As of September 30, 2020, the Board had not
elected to effect a Reverse Split. The authorization for the
Reverse Split will expire on December 19, 2020.
Common Stock
The
Company had 28,881,984 and 26,800,519 shares of its Common Stock
issued and outstanding at September 30, 2020 and December 31, 2019,
respectively.
Each holder of Common Stock is entitled to one vote for each share
of Common Stock held on all matters submitted to a vote of the
stockholders. Our Charter and Amended and Restated Bylaws (the
“Bylaws”) do not provide for cumulative voting
rights.
In
addition, the holders of our Common Stock will be entitled to
receive ratably such dividends, if any, as may be declared by the
Board out of legally available funds; however, the current policy
of our Board is to retain earnings, if any, for operations and
growth. Upon liquidation, dissolution or winding-up, the holders of
our Common Stock will be entitled to share ratably in all assets
that are legally available for distribution.
Holders of our Common Stock have no preemptive, conversion or
subscription rights, and there are no redemption or sinking fund
provisions applicable to the Common Stock. The rights, preferences
and privileges of the holders of Common Stock are subject to, and
may be adversely affected by, the rights of the holders of shares
of any series of our preferred stock that we may designate and
issue in the future.
Preferred Stock
We have 10,000,000 shares of preferred stock, par value $0.0001 per
share, authorized and available for issuance in one or more series.
The Board is authorized to divide the preferred stock into any
number of series, fix the designation and number of each such
series, and determine or change the designation, relative rights,
preferences, and limitations of any series of preferred stock. The
Board of may increase or decrease the number of shares initially
fixed for any series, but no decrease may reduce the number below
the shares then outstanding and duly reserved for
issuance.
On July 16, 2020, we authorized 5,194.805195 shares as Series B
Preferred Stock and issued 2,912.583005 shares of Series B Preferred Stock, with 2,282.222190
shares of Series B Preferred Stock remaining authorized but
unissued. Following such transactions, we currently have
2,912.583005 shares of preferred stock issued and outstanding with
9,997,087.416995 shares of preferred stock remaining authorized but
unissued.
Series B Convertible Preferred Stock
Pursuant to the Certificate of Designation of Rights and
Preferences of the Series B Preferred Stock (the
“Series B Certificate of
Designation”), the terms
of the Series B Preferred Stock are as follows:
Ranking
The Series B Preferred Stock will rank senior to the Common Stock
with respect to distributions of assets upon the liquidation,
dissolution or winding up of the Company.
Stated Value
Each share of Series B Preferred Stock has a stated value of
$7,700, subject to adjustment for stock splits, combinations and
similar events (the “Series B Stated
Value”).
Dividends
Each holder of shares of Series B Preferred Stock, in preference
and priority to the holders of all other classes or series of stock
of the Company, is entitled to receive dividends, commencing from
the date of issuance. Such dividends may be paid by the Company
only when, as and if declared by the Board, out of assets legally
available therefor, semiannually in arrears on the last day of June
and December in each year, commencing December 31, 2020, at the
dividend rate of 9.0% per year, which is cumulative and continues
to accrue on a daily basis whether or not declared and whether or
not the Company has assets legally available therefor. The Company
may pay such dividends at its option either in cash or in kind in
additional shares of Series B Preferred Stock (rounded down to the
nearest whole share), provided the Company must pay in cash the
fair value of any such fractional shares in excess of $100.00. At
September 30, 2020 the dividend payable to the holders of the
Series B Preferred Stock aggregated to approximately
$408,043.
Liquidation Preference; Liquidation Rights
Under the Certificate of Designations, each share of Series B
Preferred Stock carries a liquidation preference equal to the
Series B Stated Value (as adjusted thereunder) plus accrued and
unpaid dividends thereon (the “Liquidation
Preference”).
If the Company voluntarily or involuntarily liquidates, dissolves
or winds up its affairs, each holder of the Series B Preferred
Stock will be entitled to receive out of the Company’s assets
available for distribution to stockholders, after satisfaction of
liabilities to creditors, if any, but before any distribution of
assets is made on the Common Stock or any of the Company’s
shares of stock ranking junior as to such a distribution to the
Series B Preferred Stock, a liquidating distribution in the amount
of the Stated Value of all such holder’s Series B Preferred
Stock plus all accrued and unpaid dividends thereon. At September
30, 2020, the value of the liquidation preference of the Series B
Preferred stocks aggregated to approximately $22.6
million.
Conversion
Each share of Series B Preferred Stock will be convertible at the
holder’s option at any time, into Common Stock at a
conversion rate equal to the quotient of (i) the Series B Stated
Value divided by (ii) the initial conversion price of $0.77,
subject to specified adjustments for stock splits, cash or stock
dividends, reorganizations, reclassifications other similar events
as set forth in the Series B Certificate of Designations. In
addition, at any time after the six month anniversary of the Series
B Closing Date, if the closing sale price per share of Common Stock
exceeds 250% of the initial conversion price, or $1.925, for 20
consecutive trading days, then all of the outstanding shares of
Series B Preferred Stock will automatically convert (the
“Automatic
Conversion”) into such
number of shares of Common Stock as is obtained by multiplying the
number of shares of Series B Preferred Stock to be so converted,
plus the amount of any accrued and unpaid dividends thereon, by the
Series B Stated Value per share and dividing the result by the then
applicable conversion price. The Series B Preferred Stock contains
limitations that prevent the holder thereof from acquiring shares
of Common Stock upon conversion (including pursuant to the
Automatic Conversion) that would result in the number of shares
beneficially owned by such holder and its affiliates exceeding
9.99% of the total number of shares of Common Stock outstanding
immediately after giving effect to the conversion, which percentage
may be increased or decreased at the holder’s election not to
exceed 19.99%.
Most Favored Nations Exchange Right
In the event the Company effects any issuance by the Company or any
of its subsidiaries of Common Stock or Common Stock equivalents for
cash consideration, or a combination of units thereof (a
“Subsequent
Financing”), each holder
of the Series B Preferred Stock has the right, subject to certain
exceptions set forth in the Series B Certificate of Designations,
at its option, to exchange (in lieu of cash subscription payments)
all or some of the Series B Preferred Stock then held (with a value
per share of Series B Preferred Stock equal to the Liquidation
Preference) for any securities or units issued in a Subsequent
Financing on dollar-for-dollar basis.
Voting
The holders of the Series B Preferred Stock, voting as a separate
class, will have customary consent rights with respect to certain
corporate actions of the Company. The Company may not take the
following actions without the prior consent of the holders of at
least a majority of the Series B Preferred Stock then outstanding:
(a) authorize, create, designate, establish, issue or sell an
increased number of shares of Series B Preferred Stock or any other
class or series of capital stock ranking senior to or on parity
with the Series B Preferred Stock as to dividends or upon
liquidation; (b) reclassify any shares of Common Stock or any other
class or series of capital stock into shares having any preference
or priority as to dividends or upon liquidation superior to or on
parity with any such preference or priority of Series B Preferred
Stock; (c) amend, alter or repeal the Certificate of Incorporation
or Bylaws of the Company and the powers, preferences, privileges,
relative, participating, optional and other special rights and
qualifications, limitations and restrictions thereof, which would
adversely affect any right, preference, privilege or voting power
of the Series B Preferred Stock; (d) issue any indebtedness or debt
security, other than trade accounts payable, insurance premium
financings and/or letters of credit, performance bonds or other
similar credit support incurred in the ordinary course of business,
or amend, renew, increase, or otherwise alter in any material
respect the terms of any such indebtedness existing as of the date
of first issuance of shares of Series B Preferred Stock; (e)
redeem, purchase, or otherwise acquire or pay or declare any
dividend or other distribution on (or pay into or set aside for a
sinking fund for any such purpose) any capital stock of the
Company; (f) declare bankruptcy, dissolve, liquidate, or wind up
the affairs of the Company; (g) effect, or enter into any agreement
to effect, a Change of Control (as defined in the Certificate of
Designations); or (h) materially modify or change the nature of the
Company’s business.
2014 Equity Incentive Plan
The
Company’s Board and stockholders adopted and approved the
Amended and Restated 2014 Omnibus Equity Incentive Plan (the
“2014 Plan”),
which took effect on May 12, 2014. From the adoption and approval
of the 2020 Plan on September 11, 2020, no new awards have been or
will be made under the 2014 Plan.
The
2014 Plan allowed for the issuance of securities, including stock
options to employees, Board members and consultants. The number of
shares of Common Stock reserved for issuance under the 2014 Plan
could not exceed ten percent (10%) of the issued and outstanding
shares of Common Stock on an as converted basis (the
“As Converted
Shares”) on a rolling basis. For calculation purposes,
the As Converted Shares included all shares of Common Stock and all
shares of Common Stock issuable upon the conversion of outstanding
preferred stock and other convertible securities but did not
include any shares of Common Stock issuable upon the exercise of
options, or other convertible securities issued pursuant to the
2014 Plan. The number of authorized shares of Common Stock reserved
for issuance under the 2014 Plan was automatically be increased
concurrently with the Company’s issuance of fully paid and
non- assessable shares of As Converted Shares. Shares were deemed
to have been issued under the 2014 Plan solely to the extent
actually issued and delivered pursuant to an award.
On July 16, 2020, the Board approved an amendment to the 2014 Plan.
The amendment eliminates individual grant limits under the 2014
Plan that were intended to comply with the exemption for
“performance-based compensation” under
Section 162(m) of the Internal Revenue Code, which section has
been repealed.
The
Company issued an aggregate of 795,006 and 0 stock options, during
the nine months ended September 30, 2020 and 2019, respectively,
under the 2014 Plan (see Note 13). Upon adoption of the 2020
Omnibus Equity Incentive Plan on September 11, 2020, the Company
will no longer make grants under the 2014 Plan.
2020 Equity Incentive Plan
The
Company’s Board and stockholders adopted and approved the
2020 Omnibus Equity Incentive Plan (the “2020 Plan”), which took effect on
September 11 ,2020. The 2020 Plan allows for the issuance of
securities, including stock options to employees, Board members and
consultants. The initial number of
shares of Common Stock available for issuance under the 2020 Plan
is 10,000,000 shares, which will, on January 1 of each calendar
year, unless the Board decides otherwise, automatically increase to
equal ten percent (10%) of the total number of shares of Common
Stock outstanding on December 31 of the immediately preceding
calendar year, calculated on an As Converted Basis. As Converted
Shares include all outstanding shares of Common Stock and all
shares of Common Stock issuable upon the conversion of outstanding
preferred stock, warrants and other convertible securities, but
will not include any shares of Common Stock issuable upon the
exercise of options and other convertible securities issued
pursuant to either the 2014 Plan or the 2020 Plan. The number of
shares permitted to be issued as “incentive stock
options” (“ISOs”) from is 15,000,000 under the 2020
Plan.
As of
September 30, 2020, no grants were issued under the 2020 Plan and
an aggregate of 10,000,000 total shares are available under the
2020 Plan.
Equity Line with Lincoln Park
On
November 13, 2019, the Company entered into a purchase agreement
(the “Equity Line
Agreement”), together with a registration rights
agreement (the “Lincoln Park
Registration Rights Agreement”), with Lincoln Park.
Under the terms of the Equity Line Agreement, Lincoln Park has
committed to purchase up to $15,000,000 of our Common Stock (the
“Equity Line”).
Upon execution of the Equity Line Agreement, the Company issued
Lincoln Park 487,168 shares of Common Stock (the
“Commitment
Shares”) as a fee for its commitment to purchase
shares of our Common Stock under the Equity Line Agreement. The
remaining shares of our Common Stock that may be issued under the
Equity Line Agreement may be sold by the Company to Lincoln Park at
our discretion from time-to-time over a 30-month period commencing
after the satisfaction of certain conditions set forth in the
Equity Line Agreement, subject to the continued effectiveness of a
registration statement covering such shares of Common Stock sold to
Lincoln Park by the Company. The registration statement was filed
with the SEC on December 31, 2019 and was declared effective on
January 14, 2020.
Under
the Equity Line Agreement, on
any business day over the term of the Equity Line Agreement, the Company has the right,
in its sole discretion, to present Lincoln Park with a purchase notice (each, a
“Purchase
Notice”) directing
Lincoln Park to purchase up to 150,000
shares of Common Stock per business day (the
“Regular
Purchase”). In each
case, Lincoln Park’s
maximum commitment in any single Regular Purchase may not exceed
$1,000,000. The Equity Line
Agreement provides for a purchase price per Purchase Share (the
“Purchase
Price”) equal to the
lesser of:
|
●
|
the lowest sale price of Common Stock on the purchase date;
and;
|
|
|
|
|
●
|
the average of the three lowest closing sale prices for the
Common Stock during the ten consecutive business days ending on the
business day immediately preceding the purchase date of such
shares;
|
In addition, on any date on which the Company submits a Purchase
Notice to Lincoln Park, the
Company also has the right, in its sole discretion, to
present Lincoln Park with an
accelerated purchase notice (each, an “Accelerated Purchase
Notice”) directing
Lincoln Park to purchase an amount of
stock (the “Accelerated
Purchase”) equal to up to
the lesser of (i) three times the number of shares purchased
pursuant to such Regular Purchase; and (ii) 30% of the aggregate
shares of Common Stock traded during all or, if certain trading
volume or market price thresholds specified in the
Equity Line Agreement are crossed on
the applicable Accelerated Purchase date, the portion of the normal
trading hours on the applicable Accelerated Purchase date prior to
such time that any one of such thresholds is crossed (such period
of time on the applicable Accelerated Purchase Date, the
“Accelerated Purchase
Measurement Period”),
provided that Lincoln Park will
not be required to buy shares pursuant to an Accelerated Purchase
Notice that was received by Lincoln Park on any business day on which the last
closing trade price of Common Stock on the Nasdaq Capital Market
(or alternative national exchange) is below $0.25 per share. The
purchase price per share for each such Accelerated Purchase will be
equal to the lesser of:
|
●
|
97% of the volume weighted average price of the
Company’s common stock during the applicable Accelerated
Purchase Measurement Period on the applicable Accelerated Purchase
date; and
|
|
|
|
|
●
|
the closing sale price of Common Stock on the applicable
Accelerated Purchase Date.
|
The Company may also direct Lincoln Park on any business day on which an
Accelerated Purchase has been completed and all of the shares to be
purchased thereunder have been properly delivered to
Lincoln Park in accordance with
the Equity Line Agreement, to
purchase an amount of stock (the “Additional Accelerated
Purchase”) equal to up to
the lesser of (i) three times the number of shares purchased
pursuant to such Regular Purchase; and (ii) 30% of the aggregate
number of shares of Common Stock traded during a certain portion of
the normal trading hours on the applicable Additional Accelerated
Purchase date as determined in accordance with the Purchase
Agreement (such period of time on the applicable Additional
Accelerated Purchase date, the “Additional Accelerated
Purchase Measurement Period”), provided that the closing price of the
Company’s common stock on the business day immediately
preceding such business day is not below $0.25 per share.
Additional Accelerated Purchases will be equal to the lower
of:
|
●
|
97% of the volume weighted average price of the
Company’s common stock during the applicable Additional
Accelerated Purchase Measurement Period on the applicable
Additional Accelerated Purchase date; and
|
|
|
|
|
●
|
the closing sale price of Common Stock on the applicable
Additional Accelerated Purchase.
|
During the three and nine months ended September 30, 2020,
the Company issued an aggregate of 0, and 1,495,199 shares of
Common Stock, respectively, in connection with the Equity Line
Agreement, resulting in net proceeds to the Company of
approximately $0, and $988,348, respectively.
Pursuant
to the terms of the Equity Line Agreement, without first obtaining
stockholder approval, the aggregate number of shares that the
Company is permitted to sell to Lincoln Park thereunder, when
aggregated with certain other private offerings of Common Stock, as
applicable, may not exceed 19.99% of the Common Stock outstanding
immediately prior to the execution of the Equity Line Agreement on
November 13, 2019, unless the average price of all applicable sales
thereunder exceeds $0.70 per share calculated by reference to the
“Minimum Price” under Nasdaq Listing Rule 5635(d). On
September 11, 2020, the Company received stockholder approval for
the issuances of the full $15 million available under the Equity
Line Agreement. Generally, there is approximately $14 million of
availability left for issuance pursuant to the Equity Line
Agreement.
Common Stock Issuances
During
the three months ended September 30, 2020, holders of shares of Series B Preferred Stock
converted 34.127448 shares of Series B Preferred Stock into an
aggregate of 341,274 shares of Common Stock at the stated
conversion price of $0.77 per share, plus the issuance of 4,610
shares of Common Stock for accrued dividends of $3,551 through such
conversion dates.
During
the three months ended September 30, 2020, the Company issued an
aggregate of 31,646 shares
of its Common Stock to consultants with a total grant date fair
value of approximately
$25,000 for investor
relations services provided, which was
recorded as stock-based compensation and included as part of
general and administrative expense.
During
the nine months ended September
30, 2020, the Company issued an
aggregate of 132,841 shares of its Common Stock to
consultants with a total grant date fair value of approximately $112,105 for investor relations services
provided, which was recorded was
recorded as stock-based compensation and included as part of
general and administrative expense.
During
the nine months ended September
30, 2020, the Company issued an
aggregate of 105,937 shares of its Common Stock to outside Board
members as payment of Board fees with an aggregate grant date fair
value of approximately $131,137 that was recorded as stock-based
compensation, included as part of general and administrative
expense. The aggregate effective settlement price was $1.24 per
share, and each individual stock issuance was based on the closing
stock price of the Common Stock on the initial date the payable was
accrued.
During the three and nine
months ended September 30,
2019, the Company issued 21,677 and 62,518 shares of Common Stock,
respectively, to a consultant as payment of $22,500
and $112,500, respectively, of
accounts payable related to investor relations
services.
During
the three and nine months ended September 30, 2019, the Company
issued an aggregate of 0 and 60,000 shares of its Common Stock,
respectively, to outside Board members as payment of Board fees
with an aggregate grant date fair value of approximately $0 and $123,000, respectively that was
recorded as stock-based compensation,
included as part of general and administrative
expense.
During
the period from April 6, 2020 through May 22, 2020, the Company
sold an aggregate of 1,345,199 shares of Common Stock pursuant to
the Equity Line, from which the Company derived approximately
$869,000 in net proceeds. The sales of these shares were exempt
from registration under the Securities Act of 1933, as amended, in
reliance upon Section 4(a)(2) (or Regulation D promulgated
thereunder).
Restricted Stock and Restricted Stock Units
Restricted
stock refers to shares of Common Stock subject to vesting based on
certain service, performance, and market conditions. Restricted
stock unit awards (“RSUs”) refer to an award under
the 2014 Plan, which constitutes a promise to grant shares of
Common Stock at the end of a specified restriction
period.
During the three months ended September 30, 2020, an aggregate of 1,746 unvested
restricted shares of Common Stock, subject to service
conditions, vested with a total grant
date fair value of approximately $6,289 and was recorded as
stock-based compensation, included as part of general and
administrative expense.
During the nine months ended September 30, 2020, an aggregate of 10,080 unvested
restricted shares of Common Stock, subject to service
conditions, vested with a total grant
date fair value of approximately $36,289 and was recorded as
stock-based compensation, included as part of general and
administrative expense.
During the three and nine months ended September
30, 2020, an aggregate of 0, and 4,000
unvested restricted shares of Common Stock were forfeited,
respectively.
During the three months ended September 30, 2019, the Company
issued 21,677 restricted shares of Common Stock to a consultant as
payment of $22,500 of accounts payable for investor relations
services. During the nine months ended September 30, 2019, the
Company issued 62,518 shares of Common Stock to a consultant as
payment of $112,500 of accounts payable for investor relations
services.
During the three months ended September 30, 2019, an aggregate of 43,750 unvested
restricted shares of Common Stock vested with a total grant date fair value of
approximately $63,434. 13,750 of these restricted shares vested
during the three months ended September 30, 2019 due to the terms
of such grants with a total grant date fair value of approximately
$44,834. 30,000 of these restricted shares were issued during the
three months ended September 30, 2019 to our directors as a part of
Board compensation with a total grant date fair value of
approximately $18,600.
During the nine months ended September 30, 2019, an aggregate of 223,417 unvested
restricted shares of Common Stock vested with a total grant date fair value of
approximately $556,888. 33,334 of these restricted shares with a
total grant date fair value of approximately $101,335 vested during
the nine months ended September 30, 2019 due to the Company achieving certain
clinical milestones. 41,250 of these restricted shares with a total
grant date fair value of approximately $134,501 vested during the
nine months ended September 30, 2019 due to the satisfaction of
service conditions 30,000 of these restricted shares were issued
during the three months ended September 30, 2019 to our directors
as a part of Board compensation with a total grant date fair value
of approximately $142,200.
As of September 30, 2020, the
Company had unrecognized restricted common stock expense of
approximately $393,250. Approximately $196,625 of this unrecognized
expense vests upon the first commercial sale in the United States
of MS1819 and approximately $196,625 of this unrecognized expense
vests upon the total market capitalization of the Company exceeding
$1.0 billion for 20 consecutive trading days. These milestones were
not considered probable at September 30, 2020.
Series B Private Placement
The Series B Private Placement and the Exchange
On July 16, 2020 (the “Series B Closing
Date”), the
Company consummated a private placement offering (the
“Series B Private
Placement”) whereby the
Company entered into a Convertible Preferred Stock and Warrant
Securities Purchase Agreement (the “Series B Purchase
Agreement”) with certain
accredited and institutional investors (the
“Series B
Investors”). Pursuant to
the Series B Purchase Agreement, the Company issued an aggregate of
2,912.583005 shares of Series B Convertible Preferred Stock, par
value $0.0001 per share (the “Series B Preferred
Stock”), at a price of
$7,700.00 per share, initially convertible into an aggregate of
29,125,756 shares of Common Stock at $0.77 per share, together with
warrants (the “Series B
Warrants”) to purchase an
aggregate of 14,562,826 shares of Common Stock at an exercise price
of $0.85 per share. The amount of the Series B Warrants is equal to
50% of the shares of Common Stock into which the Series B Preferred
Stock is initially convertible.
In connection with the Series B Private Placement, an aggregate of
1,975.578828 shares of Series B Preferred Stock initially
convertible into 19,755,748 shares of Common Stock and related
9,877,835 Series B Warrants were issued for cash consideration,
resulting in aggregate gross
proceeds of approximately $15.2 million and aggregate
net proceeds to the Company of
approximately $13.2 million after deducting placement agent
compensation and offering expenses.
An aggregate of 937.004177 shares of Series B Preferred Stock
initially convertible into 9,370,008 shares of Common Stock and
related Series B Warrants to purchase 4,684,991 shares of Common
Stock were issued to certain Series B Investors (the
“Exchange
Investors”) in exchange
for consideration consisting of approximately $6.9 million
aggregate outstanding principal amount, together with accrued and
unpaid interest thereon through the Series B Closing Date of
approximately $0.3 million, of certain Senior Convertible
Promissory Notes (the “Promissory
Notes”) issued between
December 20, 2019 and January 9, 2020 (the
“Exchange”), pursuant to an Exchange Addendum (the
“Exchange
Addendum”) executed by
the Company and the Exchange Investors. As additional consideration
to the Exchange Investors, the Company also issued certain
additional warrants (the “Exchange
Warrants”) to purchase an
aggregate of 1,772,937 shares of Common Stock at an exercise price
of $0.85 per share. The amount of the Exchange Warrants is equal to
25% of the shares of Common Stock into which such Promissory Notes
were originally convertible upon the initial issuance
thereof.
Pursuant to the Series B Private Placement and the Series B
Purchase Agreement, for purposes of complying with Nasdaq Listing
Rule 5635(c) and 5635(d), the Company was required to hold a
meeting of its stockholders not later than 60 days following the
Series B Closing Date to seek approval (the
“Stockholder
Approval”) for, among
other things, the issuance of shares of Common Stock upon (i) full
conversion of the Series B Preferred Stock; and (ii) full exercise
of the Series B Warrants and the Exchange Warrants. In the event
the Stockholder Approval was not received on or prior to the 90th
day following the Series B Closing Date, subject to extension upon
the prior written approval of the holders of at least a majority of
the Series B Preferred Stock then outstanding, the Company would
have been required to repurchase all of the then outstanding shares
of Series B Preferred Stock at a price equal to 150% of the stated
value thereof plus accrued and
unpaid dividends thereon, in cash. On September 11, 2020, the
Company received Stockholder Approval.
The
Company prepaid the remaining outstanding balance of $25,000
aggregate principal amount of Promissory Notes, together with
accrued and unpaid interest thereon through the prepayment date of
$1,307, held by those holders who did not participate in the
Exchange. Following these transactions, no Promissory Notes remain
outstanding.
In
connection with the Series B Private Placement, the Company paid
the placement agent 9.0% of the gross cash proceeds received by the
Company from investors introduced by the placement agent and 4.0%
of the gross cash proceeds received by the Company for all other
investors, or approximately $1.3 million. The Company also paid the
placement agent a non-accountable cash fee equal to 1.0% of the
gross cash proceeds and a cash financial advisory fee equal to 3.0%
of the outstanding principal balance of the Promissory Notes that
were submitted in the Exchange, or approximately $0.3 million in
additional cash fees in the aggregate. In addition, the Company
issued to the placement agent warrants to purchase up to 1,377,458
shares of Common Stock (the “July Placement Agent Warrants”). The
July Placement Agent Warrants have substantially the same terms as
the Series B Warrants, except the July Placement Agent Warrants
have an exercise price of $0.96 per share, are not callable,
provide for cashless exercise and are not exercisable until the
earlier of stockholder approval of the Series B Private Placement
and the date that is six months following the issuance
thereof.
-21-
Accounting for the Series B Private Placement
Upon receiving Shareholder Approval on September 11, 2020, the
Company classified the Series B Preferred Stock as permanent equity
because no features provide for redemption by the holders of the
Series B Preferred Stock or conditional redemption, which is not
solely within the Company’s control, and there are no
unconditional obligations in that (1) the Company must or may
settle in a variable number of its equity shares and (2) the
monetary value is predominantly fixed, varying with something other
than the fair value of the Company’s equity shares or varying
inversely in relation to the Company’s equity
shares.
Because the Series B Preferred Stock contain certain embedded
features that could affect the ultimate settlement of the Series B
Preferred Stock, the Company analyzed the instrument for embedded
derivatives that require bifurcation. The Company’s analysis
began with determining whether the Series B Preferred Stock is more
akin to equity or debt. The Company evaluated the
following criteria/features in this determination: redemption,
voting rights, collateral requirements, covenant provisions,
creditor and liquidation rights, dividends, conversion rights and
exchange rights. The Company determined that the Series B Preferred
Stock was more akin to equity than to debt when evaluating the
economic characteristics and risks of the entire Series B Preferred
Stock, including the embedded features. The Company then evaluated
the embedded features to determine whether their economic
characteristics and risks were clearly and closely related to the
economic characteristics and risks of the Series B Preferred Stock.
Since the Series B Preferred Stock was determined to be more akin
to equity than debt, and the underlying that causes the value of
the embedded features to fluctuate would be the value of the
Company’s common stock, the embedded features were considered
clearly and closely related to the Series B Preferred Stock. As a
result, the embedded features would not need to be bifurcated from
the Series B Preferred Stock.
Any beneficial conversion features related to the exercise of the
Most Favored Nation exchange right or the application of the
Mandatory Conversion provision will be recognized upon the
occurrence of the contingent events based on its intrinsic value at
the commitment date.
The Company concluded the freestanding Series B Warrants did not
contain any provision that would require liability classification
and therefore should be classified in stockholder’s equity,
based on their relative fair value.
The proceeds from the Series B Private Placement were allocated to
the Series B Preferred Stock and Series B Warrants based on their
relative fair values. The total
proceeds of approximately $22,426,890 were allocated as follows:
$16,474,374 to the Series B Preferred Stock, and $5,952,515 to the
Series B Warrants. After allocation of the
proceeds, the effective conversion price of the Series B Preferred
Stock was determined to be beneficial and, as a result, the Company
recorded a deemed dividend of $8,155,212 equal to the intrinsic
value of the beneficial conversion feature and recognized on the
closing date and recorded as a reduction of income available to
common stockholders in computing basic and diluted loss per
share.
The total offering costs of approximately $2,014,218 were
recognized in equity.
Note 12 – Warrants
For the nine months ended September 30, 2020, in connection with the January 2020 closings of
the Promissory Note Offering, the Company issued Note Warrants to
investors to purchase an aggregate of 1,813,257 shares of Common
Stock with the issuance of the Promissory Notes as referenced in
Note 9. These Note Warrants were issued between January 2, 2020 and
January 9, 2020, are exercisable commencing six (6) months
following the issuance date at $1.07 per share and expire five
years from issuance. The total grant date fair value of these
warrants was determined to be approximately $1,574,886, as
calculated using the Black-Scholes model, and were recorded as a
debt discount based on their relative fair
value.
For the nine months ended September 30, 2020, in connection with the January 2020 closings of
the Promissory Note Offering, the Company issued the January
Placement Agent Warrants to purchase an aggregate of 199,732 shares
of Common Stock to the placement agent and/or their designees. The
January Placement Agent Warrants were issued between January 2,
2020 and January 9, 2020, vested immediately, and expire five years
from issuance. 41,495 of these January Placement Agent Warrants are
exercisable at $1.21 per share and 158,237 are exercisable at $1.42
per share. The total grant date fair value of the January Placement
Agent Warrants was determined to be approximately $174,130, as
calculated using the Black-Scholes model, and was charged to debt
discount that will be amortized over the life of the
debt.
For the three and nine months ended September 30,
2020, in connection with the closing
of the Series B Private Placement, the Company issued Series B
Warrants to investors to purchase an aggregate of 14,562,826 shares
of Common Stock with the issuance of the Series B Preferred Stock
as referenced in Note 11. These Series B Warrants were issued on
July 16, 2020, are exercisable commencing six (6) months following
the issuance date at $0.85 per share and expire five years from
issuance. The total grant date fair value of the Series B Warrants
was determined to be approximately $8,103,277, as calculated using
the Black-Scholes model, and were recorded as equity based on their
relative fair value (See Note 11).
For the three and nine months ended September 30,
2020, in connection with the closing
of the Exchange (See Note 11), the Company issued Exchange Warrants
to certain investors to purchase an aggregate of 1,772,937 shares
of Common Stock with the issuance of the Series B Preferred Stock
as referenced in Note 11. These Exchange Warrants were issued on
July 16, 2020, are exercisable commencing six (6) months following
the issuance date at $0.85 per share and expire five years from
issuance. The total grant date fair value of the Exchange warrants
was determined to be approximately $986,526, as calculated using
the Black-Scholes model, and were recorded as part of the loss on
extinguishment (See Note 9).
For the three and nine months ended September 30,
2020, in connection with the closing
of the Series B Private Placement, the Company issued the July
Placement Agent Warrants to purchase an aggregate of
1,377,458 shares of Common Stock to
the placement agent and/or their designees as referenced in Note
11. The July Placement Agent Warrants were issued on July 16, 2020,
are exercisable commencing six (6) months following the issuance
date at $0.96 per share and expire five years from issuance. The
total grant date fair value of the July Placement Agent Warrants
was determined to be approximately $744,378, as calculated using
the Black-Scholes model, and were recorded as equity (See Note
11).
For the three and nine months ended September 30, 2020,
in connection with the Spoor
Settlement and Release (See Note 18), on July 14, 2020 the Company
granted Mr. Spoor warrants to purchase an aggregate of 150,000
shares of Common Stock. The warrants were immediately exercisable,
have an exercise price equal to $1.00 per share, a five-year term
and may be exercised pursuant to a cashless exercise provision
commencing six months from the issuance date. The total grant date
fair value of these warrants was determined to be approximately
$85,770, as calculated using the Black-Scholes model, and were
included in the gain on settlement (See Note
18).
During the nine months ended September 30, 2020, warrants to purchase an aggregate of
59,774 shares of Common Stock expired with exercise prices ranging
between $3.25 and $7.37 per share.
Warrant
transactions for the nine months ended September 30, 2020 and 2019
were as follows:
|
|
|
Exercise
|
Weighted
|
|
|
|
Price Per
|
Average
|
|
|
Warrants
|
Share
|
Exercise Price
|
|
|
|
|
|
|
Warrants outstanding and exercisable at January 1,
2019
|
3,112,715
|
$2.55 - 7.37
|
$4.83
|
|
|
|
|
|
|
Granted
during the period
|
275,663
|
$2.55 – 2.82
|
$2.68
|
|
Expired
during the period
|
-
|
-
|
-
|
|
Exercised
during the period
|
-
|
-
|
-
|
|
Warrants outstanding and exercisable at September 30,
2019
|
3,388,378
|
$1.50 - 7.37
|
$3.51
|
|
|
|
|
|
|
|
|
|
|
|
Warrants outstanding and exercisable at January 1,
2020
|
5,378,288
|
$1.07 - 7.37
|
$2.53
|
|
|
|
|
|
|
Granted
during the period
|
19,881,654
|
$0.85 - 1.42
|
$0.88
|
|
Expired
during the period
|
(59,774)
|
$3.25 - 7.37
|
$5.15
|
|
Exercised
during the period
|
-
|
-
|
-
|
|
Warrants outstanding and exercisable at September 30,
2020
|
25,200,168
|
$0.85 - 7.37
|
$1.22
|
|
|
|
Number of
|
Weighted Average
|
Weighted
|
|
|
|
Shares Under
|
Remaining Contract
|
Average
|
|
|
Exercise Price
|
Warrants
|
Life in Years
|
Exercise Price
|
|
|
$0.00 - 0.99
|
17,718,665
|
4.79
|
|
|
|
$1.00 - 1.99
|
5,362,464
|
3.65
|
|
|
|
$2.00 - 2.99
|
320,063
|
2.82
|
|
|
|
$3.00 - 3.99
|
635,019
|
1.57
|
|
|
|
$4.00 - 4.99
|
164,256
|
1.53
|
|
|
|
$5.00 - 5.99
|
783,132
|
1.42
|
|
|
|
$6.00 - 6.99
|
187,750
|
1.01
|
|
|
|
$7.00 - 7.37
|
28,819
|
0.28
|
|
|
Totals
|
|
25,200,168
|
4.28
|
$1.22
|
The weighted average fair value of warrants granted during the nine
months ended September 30, 2020
was $0.88 per share. The fair value was estimated on the grant
dates using the Black-Scholes option-pricing model with the
following weighted average assumptions:
|
|
September 30,
|
|
|
2020
|
|
Expected
life (in years)
|
5
|
|
Volatility
|
84.7%
|
|
Risk-free
interest rate
|
0.28-1.67%
|
|
Dividend
yield
|
-%
|
Note 13 - Stock Options
Under the 2014 Plan and the 2020 Plan, the fair value of options
granted is estimated on the grant date using the Black-Scholes
option valuation model. This valuation model for stock-based
compensation expense requires the Company to make assumptions and
judgments about the variables used in the calculation, including
the expected term (weighted-average period of time that the options
granted are expected to be outstanding), the volatility of the
common stock price and the assumed risk-free interest rate. The
Company recognizes stock-based compensation expense for only those
shares expected to vest over the requisite service period of the
award. No compensation cost is recorded for options that do not
vest and the compensation cost from vested options, whether
forfeited or not, is not reversed.
During the three months ended September 30, 2020, the Company
issued stock options to purchase an aggregate of 2,040,000 shares
of Common Stock with a strike price of $0.85 per share and a term
of ten years to its employees. These options had a total grant date
fair value of approximately $1,449,130, as calculated using the
Black-Scholes model.
During the three months ended September 30, 2020, the Board
approved an amended and restated option grant to its chief
financial officer, amending and restating a grant previously made
on January 2, 2020, to reduce the amount of shares issuable upon
exercise of such option to be the maximum number of shares Mr.
Schneiderman was eligible to receive under the 2014 Incentive Plan
on the original grant date, or 300,000 shares, due to the 2014
Incentive Plan provisions relating to the Section 162(m)
limitations described above. The Board also approved the issuance
of a replacement option covering the balance of shares intended to
be issued at that time, or 35,006 shares. The original stock option
has an exercise price of $1.03, the closing sale price of Common
Stock on January 2, 2020, which was the date of its original grant,
and the replacement stock option has an exercise price of $0.85,
the closing sale price of the Common Stock on its date of grant.
Both the original stock option and the replacement stock option
vest over a term of three years, in 36 equal monthly installments
on each monthly anniversary of January 2, 2020. On the issuance
date, 6,336 shares had vested, and 28,670 shares were unvested with
$24,102 of unrecognized expense. The Company determined the
cancellation and reissue of these stock options resulted in an
effective repricing of the stock options and modification
accounting should be applied under ASC 718. The fair value of the
original stock options immediately prior to the modification was
$23,454 and the grant date fair value of the replacement stock
options was $24,154. The Company will recognize a total of $24,802
over the remaining requisite service period through January 1,
2023.
During the nine months ended September 30, 2020, the Company
issued stock options to
purchase an aggregate of 335,006 shares of Common Stock with a strike price of
$1.03 per share and a term of ten years to its chief financial
officer that vest quarterly over three years. These options had a
total grant date fair value of approximately $281,405, as
calculated using the Black-Scholes model.
During the nine months ended September 30, 2020, the Company issued
stock options to purchase an aggregate of 460,000 shares of Common
Stock with a strike price of $0.97 per share and a term of ten
years to its non-executive directors. These options had a total
grant date fair value of approximately $210,284, as calculated
using the Black-Scholes model.
During the nine months ended September 30, 2020, stock options to
purchase an aggregate of 235,006 shares of Common Stock were
cancelled with strike prices ranging between $0.97 and $3.60 per
share.
During the three months ended September 30, 2020, stock options to
purchase an aggregate of 234,252 shares of Common Stock, subject
to service conditions, vested
with a total grant date fair value of approximately $139,392 and
recorded as stock-based compensation, of which $119,514 was
included as part of general and administrative expense and $19,878
was included as part of research and development
expense.
During the nine months ended September 30, 2020, stock options to
purchase an aggregate of 600,086 shares of Common Stock, subject
to service conditions, vested
with a total grant date fair value of approximately $360,519 and
recorded as stock-based compensation, of which $340,640 was
included as part of general and administrative expense and $19,878
was included as part of research and development
expense.
During the nine months ended September 30, 2020, stock options to
purchase an aggregate of 50,000 shares of Common Stock, subject to
performance conditions vesting, vested with a total grant date fair
value of approximately $20,150 and were recorded as stock-based
compensation, and included as part of general and administrative
expense due to the Company initiating the Option 2 Clinical
Trial.
During the three and nine months ended September 30, 2020, stock
options to purchase an aggregate of 35,006, and 235,006 shares of
Common Stock were cancelled, respectively, with strike prices
ranging between $0.97 and $3.60 per share.
During the three and nine months ended September 30, 2019, stock
options to purchase an aggregate of 893,500 shares of Common Stock
were granted with an exercise price of $1.75 and a term of five
years. During the three months ended September 30, 2019, no options
vested. During the nine months ended September 30, 2019, stock
options to purchase an aggregate 244,500 shares of Common Stock
vested with a total grant date fair value of approximately
$511,335. stock options to purchase an aggregate 242,000 shares of
Common Stock with a total grant date fair value of approximately
$501,666 vested due to the Company achieving certain clinical
milestones.
The fair values were estimated on the grant dates using the
Black-Scholes option-pricing model with the following
weighted-average assumptions:
|
|
September 30,
|
|
|
2020
|
|
Expected
life (in years)
|
10
|
|
Volatility
|
84.0%
|
|
Risk-free
interest rate
|
0.62- 1.88%
|
|
Dividend
yield
|
-%
|
The
expected term of the options is based on expected future employee
exercise behavior. Volatility is based on the historical volatility
of the Company’s Common Stock if available or of several
public entities that are similar to the Company. The Company bases
volatility this way because it may not have sufficient historical
transactions in its own shares on which to solely base expected
volatility. The risk-free interest rate is based on the U.S.
Treasury rates at the date of grant with maturity dates
approximately equal to the expected term at the grant date. The
Company has not historically declared any dividends and does not
expect to in the future.
Since the adoption of the 2020 Plan on September 11, 2020, no
awards have yet been made thereunder. During the nine months ended
September 30, 2020 and 2019, stock option activity under the 2014
Plan was as follows:
|
|
Number
|
Average
|
Remaining Contract
|
Intrinsic
|
|
|
of Shares
|
Exercise Price
|
Life in Years
|
Value
|
|
|
|
|
|
|
|
Stock options outstanding at January 1, 2019
|
994,000
|
$3.58
|
5.42
|
$-
|
|
|
|
|
|
|
|
Granted
during the period
|
893,500
|
$1.70
|
4.96
|
-
|
|
Expired
during the period
|
-
|
-
|
-
|
-
|
|
Canceled
during the period
|
-
|
-
|
-
|
-
|
|
Exercised
during the period
|
-
|
-
|
-
|
-
|
|
Stock options outstanding at September 30, 2019
|
1,887,500
|
$2.58
|
4.69
|
$-
|
|
|
|
|
|
|
|
Exercisable at September 30, 2019
|
994,000
|
$3.58
|
5.17
|
$-
|
|
|
|
|
|
|
|
Non-vested stock options outstanding at January 1,
2019
|
244,500
|
$3.05
|
4.53
|
$-
|
|
|
|
|
|
|
|
Granted
during the period
|
893,500
|
$1.70
|
4.96
|
-
|
|
Vested
during the period
|
(274,500)
|
$2.91
|
3.88
|
-
|
|
Expired
during the period
|
-
|
-
|
-
|
-
|
|
Canceled
during the period
|
-
|
-
|
-
|
-
|
|
Exercised
during the period
|
-
|
-
|
-
|
-
|
|
Non-vested stock options outstanding at September 30,
2019
|
863,500
|
$1.70
|
4.77
|
$-
|
|
Stock options outstanding at January 1, 2020
|
1,677,5000
|
$2.17
|
5.37
|
$-
|
|
|
|
|
|
|
|
Granted
during the period
|
2,870,012
|
$0.89
|
9.79
|
$-
|
|
Expired
during the period
|
-
|
-
|
|
|
|
Canceled
during the period
|
(235,006)
|
$1.94
|
3.28
|
$-
|
|
Exercised
during the period
|
-
|
-
|
|
|
|
Stock options outstanding at September 30, 2020
|
4,312,506
|
$1.38
|
7.94
|
$-
|
|
|
|
|
|
|
|
Exercisable at September 30, 2020
|
1,084,834
|
$2.59
|
5.60
|
$-
|
|
Non-vested stock options outstanding at January 1,
2020
|
883,500
|
$1.33
|
6.26
|
$-
|
|
|
|
|
|
|
|
Granted
during the period
|
2,870,012
|
$0.98
|
10.00
|
$-
|
|
Vested
during the period
|
(593,750)
|
$2.59
|
6.88
|
$-
|
|
Expired
during the period
|
-
|
-
|
-
|
|
|
Canceled
during the period
|
(160,006)
|
$1.30
|
7.10
|
$-
|
|
Exercised
during the period
|
-
|
-
|
-
|
|
|
Non-vested stock options outstanding at September 30,
2020
|
2,999,756
|
$0.98
|
8.75
|
$-
|
As of September 30, 2020, the Company had unrecognized stock-based
compensation expense of approximately $2,190,131. Approximately
$1,189,036 of this unrecognized expense will be recognized over the
average remaining vesting term of the options of.8.75 years.
Approximately $440,213 of this unrecognized expense will vest upon
enrollment completion of the next MS1819 Phase II clinical trial in the U.S.
for CF (the OPTION 2 Trial). Approximately $41,213 of this
unrecognized expense will vest upon enrollment completion of the
ongoing Combination Trial in Europe. Approximately $20,150 of this
unrecognized expense will vest upon trial completion of the
next MS1819 Phase II clinical trial in
the U.S. for CF (the OPTION 2 Trial). Approximately $40,300 of this
unrecognized expense vests upon the Company initiating a Phase III
clinical trial in the U.S. for MS1819. Approximately $40,300 of
this unrecognized expense vests upon initiating a U.S. Phase I
clinical trial for any product other than MS1819. Approximately,
$139,640 of this unrecognized expense vests upon the public release
of topline data of the complete Combination Trial results.
Approximately, $139,640 of this unrecognized expense vests upon the
public release of topline data of the complete OPTION 2 Trial
results. Approximately, $139,640 of this unrecognized expense vests
upon signing of a definitive term sheet with Board approval for
either (i) a strategic licensing, distribution or commercialization
agreement for MS1819 with a bona fide partner, or (ii) the
substantial sale of the Company or the MS1819 asset, on or before
December 31, 2021. The Company will recognize the expense related
to these milestones when the milestones become
probable.
Note 14 - Agreements
Mayoly Agreement
On March 27, 2019, the Company and Laboratories Mayoly
Spinder (“Mayoly”) entered into an Asset Purchase Agreement
(the “Mayoly APA”), pursuant
to which the Company purchased all rights, title and interest in
and to MS1819. Upon execution of the Mayoly APA, the Joint
Development and License Agreement (the “JDLA”) previously executed by AzurRx SAS and
Mayoly was terminated. In addition, the Company granted to Mayoly
an exclusive, royalty-bearing right to revenue received from
commercialization of MS1819 within certain
territories.
During the three and nine months ended September 30, 2019, the
Company charged $0 and $403,020, respectively, to Mayoly under the
JDLA that was in effect during both periods.
TransChem Sublicense
On August 7, 2017, the Company and TransChem entered into the
TransChem Sublicense Agreement pursuant to which TransChem granted
to us an exclusive license to certain patents (the
“TransChem
Licensed Patents”)
relating to H. pylori 5’methylthioadenosine nucleosidase
inhibitors. We may terminate the Sublicense Agreement and the
licenses granted therein for any reason and without further
liability on 60 days’ notice. Unless terminated earlier, the
Sublicense Agreement will expire upon the expiration of the last
Licensed Patents. Upon execution, we paid an upfront fee to
TransChem and agreed to reimburse TransChem for certain expenses
previously incurred in connection with the preparation, filing, and
maintenance of the Licensed Patents. We also agreed to pay
TransChem certain future periodic sublicense maintenance fees,
which fees may be credited against future royalties. We may also be
required to pay TransChem additional payments and royalties in the
event certain performance-based milestones and commercial sales
involving the Licensed Patents are achieved. The TransChem Licensed
Patents will allow us to develop compounds for treating
gastrointestinal, lung and other infections that are specific to
individual bacterial species. H. pylori bacterial infections are a major cause of chronic
gastritis, peptic ulcer disease, gastric cancer and other
diseases.
On March 11, 2020, the Company provided TransChem with sixty (60)
days prior written notice of its intent to terminate the TransChem
Sublicense Agreement.
No payments were made under this Sublicense Agreement during
in the three and nine months
ended September 30, 2020 and 2019,
respectively.
Employment Agreements
James Sapirstein
Effective
October 8, 2019, the Company entered into an employment agreement
with Mr. Sapirstein to serve as its President and Chief Executive
Officer for a term of three years, subject to further renewal upon
agreement of the parties. The employment agreement with Mr.
Sapirstein provides for a base salary of $450,000 per year. In
addition to the base salary, Mr. Sapirstein is eligible to receive
(i) a cash bonus of up to 40% of his base salary on an annual
basis, based on certain milestones that are yet to be determined;
(ii) 1% of net fees received by the Company upon entering into
license agreements with any third-party with respect to any product
current in development or upon the sale of all or substantially all
assets of the Company; (iii) an award grant of 200,000 restricted
stock units (“RSUs”) which are scheduled to
vest as follows (a) 100,000 shares upon the first commercial sale
of MS1819 in the U.S. and (b) 100,000 shares upon the total market
capitalization of the Company exceeding $1.0 billion for 20
consecutive trading days; (iv) a grant of 300,000 10-year stock
options to purchase shares of common stock with an exercise price
equal to $0.56 per share, which are scheduled to vest as follows
(a) 50,000 shares upon the Company initiating its next Phase II
clinical trial in the U.S. for MS1819, (b) 50,000 shares upon the
Company completing its next or subsequent Phase II clinical trial
in the U.S. for MS1819, (c) 100,000 shares upon the Company
initiating a Phase III clinical trial in the U.S. for MS1819, and
(d) 100,000 shares upon the Company initiating a Phase I clinical
trial in the U.S. for any product other than MS1819. Mr. Sapirstein
is entitled to receive 20 days of paid vacation, participate in
full employee health benefits and receive reimbursement for all
reasonable expenses incurred in connection with his services to the
Company.
In the
event that Mr. Sapirstein’s employment is terminated by the
Company for Cause, as defined in his employment agreement, or by
Mr. Sapirstein voluntarily, then he will not be entitled to receive
any payments beyond amounts already earned, and any unvested equity
awards will terminate. In the event that Mr. Sapirstein’s
employment is terminated as a result of an Involuntary Termination
Other than for Cause, as defined in his employment agreement, Mr.
Sapirstein will be entitled to receive the following compensation:
(i) severance in the form of continuation of his salary (at the
base salary rate in effect at the time of termination, but prior to
any reduction triggering Good Reason (as such term is defined in
Mr. Sapirstein’s employment agreement) for a period of twelve
months following the termination date; (ii) payment of Mr.
Sapirstein’s premiums to cover COBRA for a period of twelve
months following the termination date; and (iii) a prorated annual
bonus.
Daniel Schneiderman
Effective
January 2, 2020, the Company entered into an employment agreement
with Mr. Schneiderman to serve as the Company’s Chief
Financial Officer for a term of three years, subject to further
renewal upon agreement of the parties. The employment agreement
with Mr. Schneiderman provides for a base salary of $285,000 per
year. In addition to the base salary, Mr. Schneiderman is eligible
to receive (a) an annual milestone cash bonus based on certain
milestones that will be established by the Company’s Board or
the Compensation Committee, and (b) a grant of stock options to
purchase 335,006 shares of common stock with an exercise price of
$1.03 per share, which shall vest in three equal portions on each
anniversary date of the execution of Mr. Schneiderman’s
employment agreement, commencing on January 2, 2021, the first
anniversary date of the agreement. Mr. Schneiderman is
entitled to receive 20 days of paid vacation, participate in full
employee health benefits and receive reimbursement for all
reasonable expenses incurred in connection with his service to the
Company. The Company may terminate Mr. Schneiderman’s
employment agreement at any time, with or without Cause, as such
term is defined in his employment agreement.
In the
event that Mr. Schneiderman’s employment is terminated by the
Company for Cause, as defined in Mr. Schneiderman’s
employment agreement, or by Mr. Schneiderman voluntarily, then he
will not be entitled to receive any payments beyond amounts already
earned, and any unvested equity awards will terminate. If the
Company terminates his employment agreement without Cause, not in
connection with a Change of Control, as such term is defined in Mr.
Schneiderman’s employment agreement, he will be entitled to
(i) all salary owed through the date of termination; (ii) any
unpaid annual milestone bonus; (iii) severance in the form of
continuation of his salary for the greater of a period of six
months following the termination date or the remaining term of the
employment agreement; (iv) payment of premiums to cover COBRA for a
period of six months following the termination date; (v) a prorated
annual bonus equal to the target annual milestone bonus, if any,
for the year of termination multiplied by the formula set forth in
the agreement. If the Company terminates Mr. Schneiderman’s
employment agreement without Cause, in connection with a Change of
Control, he will be entitled to the above and immediate accelerated
vesting of any unvested options or other unvested
awards.
Dr. James E. Pennington
Effective
May 28, 2018, the Company entered into an employment agreement with
Dr. Pennington to serve as its Chief Medical Officer. The
employment agreement with Dr. Pennington provides for a base annual
salary of $250,000. In addition to his salary, Dr. Pennington is
eligible to receive an annual milestone bonus, awarded at the sole
discretion of the Board based on his attainment of certain
financial, clinical development, and/or business milestones
established annually by the Board or Compensation Committee. The
Company may terminate Dr. Pennington’s employment agreement
at any time, with or without Cause, as such term is defined in Dr.
Pennington’s employment agreement. In the event of
termination by the Company other than for Cause, Dr. Pennington is
entitled to three months’ severance payable over such period.
In the event of termination by the Company other than for Cause in
connection with a Change of Control as such term is defined in Dr.
Pennington’s employment agreement, Dr. Pennington will
receive six months’ severance payable over such
period.
Note 15 - Leases
The
Company adopted ASU 2016-02, Leases, as of January 1, 2019, using
the modified retrospective approach. Prior year financial
statements were not recast under the new standard.
The
Company leases its office and research facilities under operating
leases which are subject to various rent provisions and escalation
clauses.
During the three months ended September 30, 2020, the Company
entered into a month-to-month lease for office space in Delray
Beach, FL and one-year residential lease in Delray Beach,
FL.
During the nine months ended September 30, 2020, the Company
entered into a two-year lease extension (amendment) to is Hayward,
CA office. The Company determined that the lease modification did
not grant an additional right of use and concluded that the
modification was not a separate new lease, but rather that it
should reassess and remeasure the entire modified lease on the
effective date of the modification. The Company accounted for the
lease amendment prospectively.
The
Company’s leases expire at various dates through 2022. The
escalation clauses are indeterminable and considered not material
and have been excluded from minimum future annual rental
payments.
Lease
expense amounted to $55,418 and $52,057, respectively, in the
three months ended September 30, 2020 and 2019.
Lease
expense amounted to $128,663 and $153,723, respectively, in
the nine months ended September 30, 2020 and 2019.
The
weighted-average remaining lease term and weighted-average discount
rate under operating leases at September 30, 2020 are:
|
|
September
30,
|
|
|
2020
|
|
Lease term and discount rate
|
|
|
Weighted-average
remaining lease term
|
1.16 years
|
|
Weighted-average
discount rate
|
6.0%
|
Maturities of
operating lease liabilities at September 30, 2020 are as
follows:
|
2020
|
$30,565
|
|
2021
|
55,420
|
|
2022
|
23,375
|
|
Total
lease payments
|
109,360
|
|
Less
imputed interest
|
(3,736)
|
|
Present
value of lease liabilities
|
$105,624
|
Note 16 - Income Taxes
The
Company is subject to taxation at the federal level in both the
United States and France and at the state level in the United
States. At September 30, 2020 and December 31, 2019, the Company
had no tax provision for either jurisdiction.
At
September 30, 2020 and December 31, 2019, the Company had gross
deferred tax assets of approximately $20,059,000 and $16,372,000,
respectively. As the Company cannot determine that it is more
likely than not that the Company will realize the benefit of the
deferred tax asset, a valuation allowance of approximately
$20,059,000 and $16,372,000, respectively, has been established at
September 30, 2020 and December 31, 2019. The change in the
valuation allowance in the nine months ended September 30, 2020 and
2019 was $3,687,000 and $2,108,000, respectively.
At
September 30, 2020, the Company has gross net operating loss
(“NOL”)
carryforwards for U.S. federal and state income tax purposes of
approximately $35,077,000 and $26,572,000, respectively. The
Company’s ability to use its NOL carryforwards may be limited
if it experiences an “ownership change” as defined in
Section 382 (“Section
382”) of the Internal Revenue Code of 1986, as
amended. An ownership change generally occurs if certain
stockholders increase their aggregate percentage ownership of a
corporation’s stock by more than 50 percentage points over
their lowest percentage ownership at any time during the testing
period, which is generally the three-year period preceding any
potential ownership change.
At
September 30, 2020 and December 31, 2019, the Company had
approximately $22,120,000 and $19,425,000, respectively, in net operating
losses which it can carryforward indefinitely to offset against
future French income.
At
September 30, 2020 and December 31, 2019, the Company had taken no
uncertain tax positions that would require disclosure under ASC
740, Accounting for Income Taxes.
Note 17 - Net Loss per Common Share
Basic
net loss per share is computed by dividing net loss available to
common stockholders by the weighted average number of common shares
outstanding during the period. Diluted earnings per share reflect,
in periods in which they have a dilutive effect, the impact of
common shares issuable upon exercise of stock options and warrants
and conversion of convertible debt that are not deemed to be
anti-dilutive. The dilutive effect of the outstanding stock options
and warrants is computed using the treasury stock
method.
At
September 30, 2020, diluted net loss per share did not include the
effect of 29,314,408 shares of Common Stock issuable upon the
conversion of Series B Preferred Stock including accrued and unpaid
dividends, 25,200,168 shares of Common Stock issuable upon the
exercise of outstanding warrants, 387,000 shares of Common Stock
pursuant to unearned and unissued restricted stock and RSUs, and
4,312,506 shares of Common Stock issuable upon the exercise of
outstanding options as their effect would be antidilutive during
the periods prior to conversion.
At
September 30, 2019, diluted net loss per share did not include the
effect of 3,388,378 shares of Common Stock issuable upon the
exercise of outstanding warrants, 416,000 shares of restricted
Common Stock not yet issued, and 1,887,500 shares of Common Stock
issuable upon the exercise of outstanding options as their effect
would be antidilutive during the periods prior to
conversion.
Note 18 - Related Party Transactions
Johan (Thijs) Spoor
During
the year ended December 31, 2015, the Company employed the services
of JIST Consulting (“JIST”), a company controlled by
Johan (Thijs) Spoor, the Company’s former Chief Executive
Officer and President, as a consultant for business strategy,
financial modeling, and fundraising. Included in accounts payable
at December 31, 2019 and 2018, is $348,400 and $478,400,
respectively, for JIST relating to Mr. Spoor’s services. Mr.
Spoor received no other compensation from the Company other than as
specified in his employment agreement. On October 8, 2019, Mr.
Spoor resigned as Chief Executive Officer and President of the
Company. In addition, Mr. Spoor
resigned as a member of the Board on April 29,
2020.
On June
29, 2019, the Company accrued an incentive bonus in the amount of
$255,000 payable to Mr. Spoor. Subsequent to Mr. Spoor’s
resignation, the Compensation Committee reviewed the accrued bonus
and determined that such amount was not owed by the Company, which
determination is being challenged by Mr. Spoor. As a result of
management’s determination, the Company reversed the accrual
in the quarter ended December 31, 2019.
All unvested shares of restricted stock and stock options subject
to time and other performance-based vesting conditions have been
forfeited in connection with Mr. Spoor's resignation as the
Company’s President and Chief Executive Officer. Mr.
Spoor also declined the right to receive 241,667 earned, but
unissued shares of restricted stock on April 29, 2020 in connection
with his resignation from the Board.
On July 9, 2020, the Company
and Johan (Thijs) Spoor, its
former Chief Executive Officer, entered into a settlement and general release (the
“Spoor Settlement and
Release”), effective July
9, 2020 (the “Spoor Settlement
Date”), of certain claims
relating to Mr. Spoor's separation from the Company on October 8,
2019. In connection with the Spoor Settlement and Release, on July
14, 2020 the Company granted Mr. Spoor warrants to purchase an
aggregate of 150,000 shares of Common Stock, which had a grant date
fair value of $85,770 (See Note 12). In addition, Mr. Spoor legally
released all claims to a discretionary bonus in the amount of
$255,000, which was originally accrued by the Company in June 2019
but was subsequently reversed during the quarter ended December 31,
2019, legally released all claims to $348,400 due to JIST
Consulting, a company controlled by Mr. Spoor and the
Company also paid Mr. Spoor's
legal expenses in the amount of $51,200. During the three
and nine months ended September 30, 2020, the Company recognized a
gain on settlement of $211,430 in connection with the Spoor
Settlement and Release.
Maged Shenouda
From October 1, 2016 until his appointment as the Company’s
Chief Financial Officer on September 25, 2017, the Company employed
the services of Maged Shenouda as a financial consultant. Included
in accounts payable at September 30, 2020 and 2019 is $10,000 and
$50,000, respectively, for Mr. Shenouda’s services. On
November 1, 2019, Mr. Shenouda submitted his resignation as Chief
Financial Officer of the Company, effective November 30,
2019.
On June 29, 2019, the Company accrued an incentive bonus in the
amount of $100,000 payable to Mr. Shenouda. Subsequent to Mr.
Shenouda’s resignation, the Compensation Committee reviewed
the accrued bonus and determined that such amount should not be
paid, and the Company reversed the accrual in the quarter ended
December 31, 2019.
On July
2, 2020, the Company and Maged Shenouda, its former Chief Financial
Officer also entered into a settlement and general release (the
“Shenouda Settlement and
Release”), of certain claims relating to Mr.
Shenouda’s s separation from the Company effective November
30, 2019. In connection with the Shenouda Settlement and Release,
the Company paid a total of $15,000 to Mr. Shenouda, which amount
includes $10,000 of accounts payable of the Company due to Mr.
Shenouda for services provided and $5,000 for legal expenses, and
Mr. Shenouda legally released
all claims to a discretionary
bonus in the amount of $100,000 originally accrued by the Company
in June 2019, but was subsequently
reversed during the quarter ended December 31,
2019.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
References in this report to “AzurRx,”
“Company,” “we,” “us,”
“our,” or similar references mean AzurRx BioPharma,
Inc. and its subsidiaries on a consolidated basis. References to
“AzurRx BioPharma” refer to AzurRx BioPharma, Inc. on
an unconsolidated basis. References to “AzurRx SAS”
refer to AzurRx BioPharma’s wholly owned subsidiary through
which we conduct our European operations. References to the
“SEC” refer to the U.S. Securities and Exchange
Commission.
Forward-Looking Statements
You should read the following discussion and analysis of our
financial condition and results of operations in conjunction with
our consolidated financial statements and the related notes
included elsewhere in this interim report. Our consolidated
financial statements have been prepared in accordance with U.S.
GAAP. The following discussion and analysis contains
forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, as amended (the “Exchange
Act”), including, without limitation, statements regarding
our expectations, beliefs, intentions or future strategies that are
signified by the words “expect,”
“anticipate,” “intend,”
“believe,” or similar language. Our business and
financial performance are subject to substantial risks and
uncertainties. Actual results, performance or achievements of
the company and its clinical trials may differ
materially from those indicated by such
forward-looking statements as a result of various
important factors, including whether the Company’s cash
resources will be sufficient to fund its continuing operations for
the periods and/or trials anticipated; whether results obtained in
preclinical and nonclinical studies and clinical trials will be
indicative of results obtained in future clinical trials; whether
preliminary or interim results from a clinical trial such as the
interim results presented will be indicative of the final results
of the trial; whether the Company’s product candidates will
advance through the clinical trial process on a timely basis, or at
all; whether the results of such trials will warrant submission for
approval from the United States Food and Drug Administration or
equivalent foreign regulatory agencies; whether the Company’s
product candidates will receive approval from regulatory agencies
on a timely basis or at all; whether, if product candidates obtain
approval, they will be successfully distributed and marketed;
whether the coronavirus pandemic will have an impact on the timing
of our clinical development, clinical supply and our operations;
and other factors discussed in the “Risk Factors”
section of the Company’s annual report on
Form 10-K for the period ended December 31,
2019, and
risks described in other filings that the Company may make with the
Securities and Exchange Commission. Readers are cautioned not to
place undue reliance on these forward-looking statements. Any
forward-looking statements contained in this report speak
only as of the date hereof, and the Company specifically disclaims
any obligation to update any forward-looking statement, whether
because of new information, future events or
otherwise.
Overview
AzurRx BioPharma, Inc. (“AzurRx” or “Parent”) was incorporated on January 30, 2014 in
the State of Delaware. In June 2014, AzurRx acquired 100% of the
issued and outstanding capital stock of AzurRx SAS (formerly
“ProteaBio Europe
SAS”), a company
incorporated in October 2008 under the laws of France. AzurRx and
its wholly-owned subsidiary, AzurRx SAS (“ABS”), are collectively referred to as the
“Company.”
The Company is engaged in the research and development of
non-systemic biologics for the treatment of patients with
gastrointestinal disorders. Non-systemic biologics are
non-absorbable drugs that act locally, i.e. the intestinal lumen,
skin or mucosa, without reaching an individual’s systemic
circulation. The Company is
currently focused on developing its lead drug candidate,
MS1819.
MS1819
MS1819 is a yeast derived recombinant lipase for the
treatment of exocrine pancreatic insufficiency (“EPI”) associated with cystic
fibrosis (“CF”)
and chronic pancreatitis (“CP”). MS1819, supplied as an oral non-systemic biologic
capsule, is derived from the Yarrowia
lipolytica yeast lipase
and breaks up fat molecules in the digestive tract of EPI patients
so that they can be absorbed as nutrients. Unlike the standard of
care, the MS1819 synthetic lipase does not contain any animal
products.
EPI is
a condition characterized by deficiency of the
exocrine pancreatic enzymes, resulting in a
patient’s inability to digest food properly, or maldigestion.
The deficiency in this enzyme can be responsible for greasy
diarrhea, fecal urge and weight loss. There are more than 30,000
patients with EPI caused by CF according to the Cystic Fibrosis
Foundation approximately and approximately 90,000 patients in the
U.S. with EPI caused by CP according to the National Pancreas
Foundation. Patients are currently treated with porcine pancreatic
enzyme replacement pills.
Ongoing Clinical Studies
MS1819 – Phase 2b OPTION 2 Cystic Fibrosis Monotherapy
Study
On
October 17, 2019, the Company announced that the Cystic Fibrosis
Foundation Data Safety Monitoring Board (the “CFF DSMB”) completed its review
of the Company’s final results of the OPTION Cross-Over Study
and had found no safety concerns for MS1819, and that the CFF DSMB
supported the Company’s plan to proceed to a higher 4.4 gram
dose of MS1819 with enteric capsules in the multi-center dose
escalation Phase 2b OPTION clinical trial (the “OPTION 2 Trial”). In December
2019, the Company submitted the clinical trial protocol to the
existing IND at the FDA. The clinical trial protocol has been
reviewed by the FDA with no comments. In April 2020, the Company
received approval to conduct the OPTION 2 Trial in Therapeutics
Development Network (“TDN”)
clinical sites in the U.S. as well as Institutional Review Board
(“IRB”)
approval to commence the OPTION 2 Trial.
The
OPTION 2 Trial is designed to investigate the safety, tolerability
and efficacy of MS1819 (2.2 gram and 4.4 gram doses in enteric
capsules) in a head-to-head manner versus the current standard of
care, porcine pancreatic enzyme replacement therapy (“PERT”)
pills. The OPTION 2 Trial will be an open-label, crossover study,
conducted in 15 sites in the U.S. and Europe. A total
of 30 CF patients 18 years or older will be enrolled.
MS1819 will be administered in enteric capsules to provide
gastric protection and allow optimal delivery of enzyme to the
duodenum. Patients will first be randomized into two cohorts:
to either the MS1819 arm, where they receive a 2.2 gram daily oral
dose of MS1819 for three weeks; or to the PERT arm, where they
receive their pre-study dose of PERT pills for three weeks. After
three weeks, stools will be collected for analysis of coefficient
of fat absorption (“CFA”). Patients
will then be crossed over for another three weeks of the
alternative treatment. After three weeks of cross-over therapy,
stools will again be collected for analysis of CFA. A parallel
group of patients will be randomized and studied in the same
fashion, using a 4.4 gram daily dose of MS1819. All patients
will be followed for an additional two weeks after completing both
crossover treatments for post study safety
observation. Patients will be assessed using descriptive
methods for efficacy, comparing CFA between MS1819 and PERT arms,
and for safety.
The Company initiated the OPTION 2 Trial in July 2020 with
the first patient screened and three clinical trial sites activated
in the U.S. In August 2020, the Company dosed the first patients
and initiated the European arm of the OPTION 2 Trial. Topline data
is anticipated in the first quarter of 2021; however, this timeline
may be further delayed due to the COVID-19 pandemic.
MS1819 – Phase 2 Combination Therapy Study
In addition to the monotherapy studies, the Company launched a
Phase 2 multi-center clinical trial (the “Combination
Trial”) in Europe to
investigate MS1819 in combination with PERT, for CF patients who
suffer from severe EPI but continue to experience clinical symptoms
of fat malabsorption despite taking the maximum daily dose of
PERTs. The Combination Trial is designed to investigate the safety,
tolerability and efficacy of escalating doses of MS1819 (700 mg,
1120 mg and 2240 mg per day, respectively), in conjunction with a
stable dose of PERTs, in order to increase CFA and relieve
abdominal symptoms in uncontrolled CF patients. A combination
therapy of PERT and MS1819 has the potential to: (i) correct
macronutrient and micronutrient maldigestion; (ii) eliminate
abdominal symptoms attributable to maldigestion; and (iii) sustain
optimal nutritional status on a normal diet in CF patients with
severe EPI.
The Company dosed the first patients in its Combination Trial in
Hungary in October 2019. Planned enrollment is expected to include
approximately 24 CF patients with severe EPI, at clinical trial
sites in Hungary and additional countries in Europe, including
Turkey. Topline data is currently expected in the first half of
2021; however, this timeline may be further delayed due to
the COVID-19 pandemic.
The
Company announced positive interim data on the first five patients
in the Combination Trial in August 2020. The primary efficacy
endpoint was met, with CFAs greater than 80% for all patients
across all visits. For secondary efficacy endpoints, the Company
observed that stool weight decreased, the number of stools per day
decreased, steatorrhea improved, and body weight increased.
Additionally, no serious adverse events were reported.
The
Company opened a total of five clinical sites for the Combination Trial in Turkey in October
2020. The Company currently has a
total of nine of the expected ten sites in Europe active and
recruiting patients.
Liquidity and Capital Resources
We have experienced net losses and negative cash flows from
operations since our inception. As of September 30, 2020, we had
cash of approximately $11.4
million and had sustained
cumulative losses attributable to common stockholders of
approximately $78.0 million. We
have not yet achieved profitability and anticipate that we will
continue to incur net losses for the foreseeable future. We
expect that our expenses will continue to grow and, as a result, we
will need to generate significant product revenues to achieve
profitability. We may never achieve profitability. As such, we are
dependent on obtaining, and are continuing to pursue, the necessary
funding from outside sources, including obtaining additional
funding from the sale of securities in order to continue our
operations. Without adequate funding, we may not be able to meet
our obligations. These conditions raise substantial doubt about our
ability to continue as a going concern.
Our primary sources of liquidity come from capital raises
through additional equity and/or debt financings. This may be impacted by the COVID-19 pandemic,
which is evolving and could negatively impact our ability to raise
additional capital in the future.
We have funded our operations to date primarily through the
issuance of debt and convertible debt securities, as well as the
issuance of our common stock, par value $0.0001 per share (the
“Common
Stock”) in various
public offerings and private placement
transactions. We expect to incur substantial expenditures in the
foreseeable future for the development of MS1819 and any other
product candidates. We will require additional financing to
develop, prepare regulatory filings and obtain regulatory
approvals, fund operating losses, and, if deemed appropriate,
establish manufacturing, sales and marketing
capabilities.
We expect to incur substantial expenditures in the foreseeable
future for the development of MS1819 and our other product
candidates. We will require additional financing to develop our
product candidates, run clinical trials, prepare regulatory filings
and obtain regulatory approvals, fund operating losses, and, if
deemed appropriate, establish manufacturing, sales and marketing
capabilities. Our current financial condition raises substantial
doubt about our ability to continue as a going concern. Our failure
to raise capital as and when needed would have a material adverse
impact on our financial condition, our ability to meet our
obligations, and our ability to pursue our business strategies. We
will seek funds through additional equity and/or debt financings,
collaborative or other arrangements with corporate sources, or
through other sources of financing.
Although we are primarily focused on the development of MS1819, we
are also opportunely focused on expanding our product pipeline
through collaborations, and also through acquisitions of products
and companies. We are continually evaluating potential asset
acquisitions and business combinations. To finance such
acquisitions, we might raise additional equity capital, incur
additional debt, or both.
Series B Private Placement and Exchange
As
described in Note 11 in the accompanying financial statements, on
July 16, 2020, we consummated a private placement of our Series B
Convertible Preferred Stock, par value $0.0001 per share (the
“Series B Preferred
Stock”) and related warrants (the “Series B Private Placement”),
resulting in aggregate gross proceeds of approximately $15.2
million and aggregate net proceeds of approximately $13.2 million,
after deducting placement agent compensation and offering
expenses.
In the
private placement we issued an aggregate of 2,912.583005 shares of
Series B Preferred Stock at a price of $7,700.00 per share,
initially convertible into an aggregate of 29,125,756 shares of
Common Stock at $0.77 per share, together with warrants (the
“Series B
Warrants”) to purchase an aggregate of 14,562,826
shares of Common Stock at an exercise price of $0.85 per
share.
In
connection with the Series B Private Placement, we issued an
aggregate of 1,975.578828 shares of Series B Preferred Stock
initially convertible into 19,755,748 shares of Common Stock and
related 9,877,835 Series B Warrants for cash consideration. In
addition, we issued the balance of an aggregate of 937.004177
shares of Series B Preferred Stock initially convertible into
9,370,008 shares of Common Stock and related Series B Warrants to
purchase 4,684,991 shares of Common Stock to certain investors in
exchange for approximately $6.9 million aggregate outstanding
principal amount, together with accrued and unpaid interest thereon
of approximately $0.3 million, of outstanding promissory notes
previously issued between December 2019 and January 2020. As
additional consideration to such investors, we also issued certain
additional warrants to purchase an aggregate of 1,772,937 shares of
Common Stock at an exercise price of $0.85 per share.
Following
the Series B Private Placement, we prepaid the outstanding balance
of $25,000 aggregate principal amount of outstanding promissory
notes, together with accrued and unpaid interest thereon through
the prepayment date, held by those holders who did not participate
in such exchange. As a result, following the consummation of the
Series B Private Placement, the Company no longer has any
convertible debt outstanding.
-34-
Continued Nasdaq Listing
On March 23, 2020, the Company received a letter from the Listing
Qualifications Staff of The Nasdaq Stock Market, LLC
("Nasdaq") indicating that, based upon the closing bid
price of the Company's Common Stock for the last 30 consecutive
business days, the Company is not currently in compliance with the
requirement to maintain a minimum bid price of $1.00 per share for
continued listing on the Nasdaq Capital Market, as set forth in
Nasdaq Listing Rule 5550(a)(2) (the "Notice").
The Notice has no immediate effect on the continued listing status
of the Company's Common Stock on the Nasdaq Capital Market, and,
therefore, the Company's listing remains fully
effective.
The Company will continue to monitor the closing bid price of its
Common Stock and seek to regain compliance with all applicable
Nasdaq requirements within the allotted compliance periods. To
regain compliance, the closing bid price of the Company's Common
Stock must be at least $1.00 per share for 10 consecutive business
days at some point during the period of 180 calendar days from the
date of the Notice, or until December 3, 2020, due to certain COVID-19 related
relief from price-based continued listing requirements issued by
Nasdaq on April 16, 2020. If the Company does not regain compliance
with the minimum bid price requirement by December 3, 2020, Nasdaq may grant the Company a
second period of 180 calendar days to regain compliance. To qualify
for this additional compliance period, the Company would be
required to meet the continued listing requirement for market value
of publicly held shares and all other initial listing standards for
the Nasdaq Capital Market, other than the minimum bid price
requirement. In addition, the Company would also be required to
notify Nasdaq of its intent to cure the minimum bid price
deficiency. If the Company does not regain compliance within the
allotted compliance periods, including any extensions that may be
granted by Nasdaq, Nasdaq will provide notice that the Company's
Common Stock will be subject to delisting. The Company would then
be entitled to appeal that determination to a Nasdaq hearings
panel. There can be no assurance that the Company will regain
compliance with the minimum bid price requirement during the
180-day compliance period, secure a second period of 180 days to
regain compliance, or maintain compliance with the other Nasdaq
listing requirements.
In addition, on August 20, 2020, the Company received a separate
letter from the Listing Qualifications Staff of Nasdaq indicating
that the Company was not in compliance with the minimum
stockholders’ equity requirement for continued listing on the
Nasdaq Capital Market, under Listing Rule 5550(b)(1 (the
“Minimum Equity
Requirement”), because
the Company’s stockholders’ equity of approximately
negative $0.8 million, as reported for the quarter ended June 30,
2020, was below the required minimum of $2.5 million, and because,
as of August 19, 2020, the Company did not meet certain alternative
compliance standards. Based on correspondence with the Listing
Qualifications Staff of Nasdaq, the Company has been granted an
extension of time to regain compliance with the Minimum Equity
Requirement, provided that the Company file its Form 10-Q for the
period ended September 30, 2020 on or before November 16, 2020,
demonstrating a minimum of $2.5 million in stockholders’
equity.
As reflected in the accompanying financial statements, as of
September 30, 2020, our stockholders’ equity was
approximately $14.0 million. Accordingly, we believe we have
evidenced compliance with the Minimum Equity Requirement, and we
anticipate resolving this matter with Nasdaq promptly following the
filing of this Form 10-Q with the Securities and Exchange
Commission.
Cash Flows for the Nine Months Ended September 30, 2020 and
2019
Net cash used in operating activities for the nine months ended
September 30, 2020 was $5,331,557, which primarily reflected our
net loss of $15,271,074 plus adjustments to reconcile net loss to
net cash used in operating activities of depreciation and
amortization expense of $422,217, non-cash stock-based compensation
of $369,517, non-cash restricted stock granted to employees and
directors of $27,292, non-cash Common Stock granted to members of
the Company's board of directors to settle accounts payable of
$131,137, non-cash Common Stock granted to consultants of $109,605,
non-cash accretion of debt discount of $4,580,167, non-cash
interest on convertible debt of $234,334, loss on debt
extinguishment of $609,998, gain on settlement of $211,430, and
beneficial conversion feature related to the promissory note
exchange of $798,413, and non-cash lease expense of $4,855. Changes
in assets and liabilities are due to a decrease in other
receivables of $2,121,336 due primarily to the payments of French
research and development (“R&D”) tax credits, a decrease in
prepaid expenses of $446,766 due primarily to the expensing of
prepaid insurance, a decrease in other liabilities of $31,104, and
a decrease of accounts payable and accrued expense of $90,147,
offset by an increase in an increase in deposits of $4,180, and an
increase in accrued dividends payable of $408,043.
Net cash used in operating activities for the nine months ended
September 30, 2019 was $10,807,517, which primarily reflected our
net loss of $13,896,063 plus adjustments to reconcile net loss to
net cash used in operating activities of depreciation and
amortization expense of $876,324, non-cash stock-based compensation
of $541,725 due primarily to achievement of certain
performance-based milestones associated with previously issued
equity awards, non-cash restricted stock granted to
employees/directors of $556,888 due primarily to reaching certain
performance-based milestones, non-cash restricted stock granted to
a consultant in payment of accounts payable for $112,500, accrued
interest on convertible debt of $124,932, and non-cash debt
discount - warrants on convertible debt of $147,461. Changes in
assets and liabilities are due to an increase in other receivables
of $261,981, a decrease in prepaid expenses of $420,218 due
primarily to the expensing of prepaid insurance, an increase in
deposits of $4,125, a decrease in accounts payable and accrued
expenses of $601,096 and a decrease in other liabilities of $23,274
primarily due to the adoption of new lease accounting
standards.
Net cash used in investing activities for the nine months ended
September 30, 2020, was $2,808, which consisted of the purchase of
property and equipment.
Net cash used in investing activities for the nine months ended
September 30, 2019 was $17,243, which consisted of the purchase of property and
equipment.
Net cash provided by financing activities for the nine months ended
September 30, 2020 was $16,493,726, compared to $11,298,574
for the nine months ended September
30, 2019, resulting in an increase of
$5,195,152.
Net cash provided by financing activities for the nine months ended
September 30, 2020 consisted of $13,197,740
from the from the issuance of the
preferred stock in the Series B Private Placement,
$3,227,002 from the issuance of
the convertible debt in our offering of Senior Convertible
Promissory Notes and warrants to purchase shares of Common Stock
that occurred in December 2019, $988,348 from the proceeds of the
Equity Line, and $179,408 from the issuance of a note payable in
connection with the PPP loan, offset by repayments of convertible
debt of $475,000 plus accrued interest of $105,460 related to the
issuance to ADEC Equity Investments, LLC of two Senior Convertible
Notes (the “ADEC Notes”) and Senior Convertible Promissory Notes,
and repayment of notes payable of $623,772, which included the
repayment of the Paycheck Protection Program
loan.
Net cash provided by financing activities for the nine months ended
September 30, 2019 was $11,298,574, which consisted of $9,492,016
from the sale of Common Stock offered in our public offerings of
Common Stock that occurred in April 2019 and in May 2019,
$2,000,000 from the issuance of the ADEC Notes, and $61,590
received from a stockholder in relation to a warrant modification
offset by repayment of a note payable of
$255,032.
Consolidated Results of Operations for the Three Months Ended
September 30, 2020 and 2019
Revenues. We have
not yet achieved revenue-generating status from any of our product
candidates. Since inception, we have devoted substantially all
of our time and efforts to developing MS1819. As a result, we
did not have any revenue during the three months ended September
30, 2020 and 2019, respectively.
Research and Development Expense. R&D expense was $1,795,684 for the three
months ended September 30, 2020, as compared to $2,221,933 for the
three months ended September 30, 2019. This represents a decrease
of $426,249 or approximately 19% for the three months ended
September 30, 2020 as compared to the three months ended September
30, 2019. Stock-based compensation for employees, depreciation and
amortization was $19,878, $4,881 and $131,887, respectively, for
the three months ended September 30, 2020, as compared to $0,
$11,842 and $131,887, respectively for the three months ended
September 30, 2019. Excluding non-cash expenses, total cash R&D
expense decreased by $439,165, or approximately 21% to $1,639,038
for the three months ended September 30, 2020, from $2,078,203 for
the three months ended September 30, 2019.
The decrease in R&D cash spending was primarily due to
decreased clinical trial costs of $378,340 related to reduced
clinical trial activity in connection with recruitment delays in
the Combination Study due to COVID-19 as compared to the prior
period when we were conducting the OPTION Trial, and decreased
personnel costs of $104,484. We expect cash R&D expense to
increase during the remainder of the fiscal year as we advance both
the OPTION 2 Trial and the Combination Trial and increase
chemistry, manufacturing, and controls (“CMC”)
activities in connection with the continued development of
MS1819.
General and Administrative Expense. General and
administrative (“G&A”) expense was $1,916,250 for the three
months ended September 30, 2020, as, as compared to $1,860,141 for
the for the three months ended September 30, 2019. This represents
an increase of $56,109, or approximately 3% for the three months
ended September 30, 2020 as compared to the three months ended
September 30, 2019. Stock-based compensation for employees and
depreciation was $148,303, and $3,307, respectively, for the three
months ended September 30, 2020, as compared to $93,824, and
$5,149, respectively for the three months ended September 30, 2019.
Excluding non-cash expenses, total cash G&A expense increased
by $3,472, or approximately 0% to $1,764,640 for the three months
ended September 30, 2020, from $1,761,169 for the three months
ended September 30, 2019.
The slight increase in G&A cash spending was primarily due to
increased legal expenses of $474,960, increased insurance of
$69,368, increased personnel expenses of $57,443, and increased
information technology expenses of $23,459, offset by decreased
other expenses of $315,442 primarily due to the fraud loss for the
three months ended September 30, 2019, cutbacks in public company
and corporate communications expense, including investor and public
relations of $136,554, decreased taxes and licenses of $50,421,
primarily due to the refund of $42,190 in the three months ended
September 30, 2020, for overpayments in prior years, elimination of
directors fees of $35,000, decreased travel and entertainment of
$32,136, decreased accounting and auditing fees of $27,399 and
decreased consulting expenses of $22,237.
We expect cash G&A expense to increase during the remainder of
this fiscal year primarily due to increases in public company and
corporate communications expenses, including investor relations,
legal expenses, fees related to business development efforts, and
information technology security expenses, among
others.
Other Expense. Other expense
for the three months ended September 30, 2020 was $1,601,972 as
compared to $110,398 for the three months ended September 30, 2019.
This represents an increase of $1,491,574 for the three months
ended September 30, 2020 as compared to the three months ended
September 30, 2019. This increase is primarily due to increased
interest expense of $1,203,404 due to amortization of debt discount
and accrued interest related to the convertible debt issued in
between December 2019 and January 2020, which was not present in
the prior period, and a loss on debt extinguishment of $609,998,
which was not present in the prior period, offset by gain on
settlement of $211,430, which was not present in the prior
period.
Net Loss. As a result of the
factors above, our net loss increased by $1,121,434 to $5,313,906
for the three months ended September 30, 2020 as compared to
$4,192,472 for the three months ended September 30,
2019.
Consolidated Results of Operations for the Nine Months Ended
September 30, 2020 and 2019
Revenues. We have
not yet achieved revenue-generating status from any of our product
candidates. Since inception, we have devoted substantially all
of our time and efforts to developing MS1819. As a result, we
did not have any revenue during the three months ended September
30, 2020 and 2019, respectively.
Research and Development Expense. R&D expense was $4,438,229 for the nine months
ended September 30, 2020, as compared to $7,927,907 for the nine
months ended September 30, 2019. This represents a decrease of
$3,489,678, or approximately 49% for the nine months ended
September 30, 2020 as compared to the nine months ended September
30, 2019. Stock-based compensation for employees,
depreciation and amortization was $28,878, $14,372, and $395,661,
respectively, for the nine months
ended September 30, 2020, as compared to $0,
$35,918 and $824,936,
respectively for the nine months ended
September 30, 2019. Excluding non-cash expenses, total cash
R&D expense decreased by $3,068,074, or approximately 43% to
$3,999,318 for the nine months ended
September 30, 2020, from $7,067,392 for the nine months ended
September 30, 2019.
The decrease in R&D cash spending was primarily due to
decreased clinical trial costs of $2,608,858 related to reduced
clinical trial activity in connection with recruitment delays in
the Combination Study due to COVID-19 as compared to the prior
period which included the OPTION trial, decreased personnel costs
of $342,887, decreased supplies and materials expenses related to
laboratory research of $57,097, and decreased consulting expenses
of $53,966. We expect cash R&D expense to increase during the
remainder of the fiscal year as we advance both the OPTION 2 Trial
and the Combination Trial and increase CMC activities in connection
with the continued development of MS1819.
General and Administrative Expense. G&A expense was $4,595,860 for the nine months
ended September 30, 2020, as, as compared to $5,690,001 for the for
the nine months ended September 30, 2019. This represents a
decrease of $1,094,141, or approximately 19% for the nine months
ended September 30, 2020 as compared to the nine months ended
September 30, 2019. Stock-based compensation for employees
and consultants, depreciation, and
loss on asset disposal was $477,537, $12,184, and
$1,998, respectively, for the
nine months ended September 30,
2020, as compared to $1,098,613, $15,343 and $0,
respectively for the nine months ended
September 30, 2019. Excluding non-cash expenses, total cash
G&A expense decreased by $471,904, or approximately 10% to
$4,104,141 for the nine months ended
September 30, 2020, from $4,576,045 for the nine months ended
September 30, 2019.
The decrease in G&A cash spending was primarily due to the
elimination of bonuses of $629,300 as compared to the prior period,
cutbacks in public company and corporate communications expense,
including investor and public relations of $280,153, directors fees
of $105,000, and travel and entertainment expenses of $72,377, and
decreased other expenses of $326,417 primarily due to the fraud
loss for the three months ended September 30, 2019, offset by
increases in legal expenses of $495,801, insurance of $203,080,
consulting expenses of $136,976, increased insurance of $203,080,
and increased information technology expenses of
$72,028.
We expect cash G&A expense to increase during the remainder of
this fiscal year primarily due to increases in public company and
corporate communications expenses, including investor relations,
legal expenses, fees related to business development efforts, and
information technology security expenses, among
others.
Other Expense. Other expense
for the nine months ended September 30, 2020 was $6,236,985 as
compared to $278,155 for the three months ended September 30, 2019.
This represents an increase of $5,958,830 for the three months
ended September 30, 2020 as compared to the three months ended
September 30, 2019. This increase is primarily due to increased
interest expense of $5,838,417 due to amortization of debt discount
and accrued interest related to the convertible debt issued in
between December 2019 and January 2020, as compared to $278,155 in
the prior period, and a loss on debt extinguishment of $609,998,
which was not present in the prior period, offset by gain on
settlement of $211,430, which was not present in the prior
period.
Net Loss. As a result of the
factors above, our net loss increased by $1,375,011 to $15,271,074
for the nine months ended September 30, 2020 as compared to
$13,896,063 for the nine months ended September 30,
2019.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISKS
Not
applicable.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a-15(b) under the Securities Exchange Act of
1934, as amended, (the “Exchange
Act”) our Chief Executive
Officer (“CEO”) and our Chief Financial Officer
(“CFO”) conducted an evaluation as of the end of
the period covered by this Quarterly Report on Form 10-Q, of the
effectiveness of our disclosure controls and procedures as defined
in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on
that evaluation, our CEO and our CFO each concluded that our
disclosure controls and procedures are effective to provide
reasonable assurance that information required to be disclosed in
the reports that we file or submit under the Exchange Act, (i) is
recorded, processed, summarized and reported within the time
periods specified in the Securities and Exchange Commission's rules
and forms and (ii) is accumulated and communicated to our
management, including our CEO and our CFO, as appropriate to allow
timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial
reporting identified in management’s evaluation pursuant to
Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the period
covered by this Quarterly Report on Form 10-Q that materially
affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
PART
II
OTHER
INFORMATION|
ITEM 1. LEGAL
PROCEEDINGS
|
None.
|
ITEM 1A. RISK FACTORS
|
Our results of operations and financial condition are subject to
numerous risks and uncertainties described in our Annual Report on
Form 10-K for our fiscal year ended December 31, 2019, filed on
March 30, 2020 as supplemented by our Quarterly Report on Form 10-Q
for the quarterly period ended June 30, 2020, as filed on August
14, 2020. You should carefully consider these risk factors in
conjunction with the other information contained in this Quarterly
Report. Should any of these risks materialize, our business,
financial condition and future prospects could be negatively
impacted. As of November 16, 2020, there have been no material
changes to the disclosures made in the above referenced Form 10-K,
as supplemented by our Quarterly Report on Form 10-Q for the
quarterly period ended June 30, 2020, as filed on August 14,
2020.
|
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
|
In our Form 8-K filed July 20, 2020, and in certain subsequent
filings with the Securities and Exchange Commission, we previously
reported that the exercise price of the warrants issued to our
placement agent in connection with our private placement of Series
B Preferred Stock, which was consummated on July 16, 2020, was
$1.06 per share. In fact, the terms of our engagement letter with
the placement agent require the exercise price for such warrants to
be $0.96 per share. Our prior disclosures are hereby updated to
reflect an exercise price of $0.96 per share for these
warrants.
-39-
|
ITEM 6. EXHIBITS
|
|
|
|
(b)
|
Exhibits
|
|
Exhibit No.
|
|
Description
|
|
|
Certificate
of the Designations, Powers, Preferences and Rights of Series B
Convertible Preferred Stock (incorporated by reference as Exhibit
3.1 of the Company’s Current Report on Form 8-K filed with
the Securities and Exchange Commission on July 20,
2020.)
|
|
|
|
Amended
and Restated Bylaws (incorporated by reference as Exhibit 3.1 of
the Company’s Current Report on Form 8-K filed with the
Securities and Exchange Commission on August 5, 2020.)
|
|
|
|
Form of
Warrant (incorporated by reference as Exhibit 4.1 of the
Company’s Current Report on Form 8-K filed with the
Securities and Exchange Commission on July 20, 2020.)
|
|
|
|
Form of
Warrant for Convertible Notes Offering (incorporated by reference
as Exhibit 4.2 of the Company’s Registration Statement on
Form S-3 filed with the Securities and Exchange Commission on July
27, 2020.)
|
|
|
|
Form of
Purchase Agreement, by and among the Company and the investors set
forth on the signature pages thereto, including the form of
Exchange Addendum (incorporated by reference as Exhibit 10.1 of the
Company’s Current Report on Form 8-K filed with the
Securities and Exchange Commission on July 20, 2020.)
|
|
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Form of
Registration Rights Agreement, by and among the Company and the
investors set forth on the signature page thereto (incorporated by
reference as Exhibit 10.2 of the Company’s Current Report on
Form 8-K filed with the Securities and Exchange Commission on July
20, 2020.)
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First
Amendment to 2014 Omnibus Equity Incentive Plan (incorporated by
reference as Exhibit 10.3 of the Company’s Current Report on
Form 8-K filed with the Securities and Exchange Commission on July
20, 2020.)
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2020
Omnibus Equity Incentive Plan.
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Certification
of the Principal Executive Officer, pursuant to Section
302 of the Sarbanes-Oxley Act of 2002.
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Certification
of the Principal Financial Officer, pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
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Certification
of the Principal Executive Officer and 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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101.INS
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XBRL
Instance Document
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101.SCH
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XBRL
Taxonomy Extension Schema
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101.CAL
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XBRL
Taxonomy Extension Calculation Linkbase
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101.DEF
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XBRL
Taxonomy Extension Definition Linkbase
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101.LAB
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XBRL
Taxonomy Extension Label Linkbase
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101.PRE
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XBRL
Taxonomy Extension Presentation Linkbase
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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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AZURRX
BIOPHARMA, INC.
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By
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/s/ James
Sapirstein
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James
Sapirstein
President, Chief Executive Officer and Director
(Principal Executive Officer)
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By
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/s/ Daniel
Schneiderman
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Date:
November 16, 2020
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Daniel
Schneiderman
Chief Financial Officer
(Principal Financial and Accounting Officer)
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-41-
Exhibit 10.4
AZURRX BIOPHARMA, INC. 2020 OMNIBUS
EQUITY INCENTIVE PLAN
(AS AMENDED AND RESTATED THROUGH AUGUST 11, 2020)
-1-
AZURRX BIOPHARMA, INC. 2020 OMNIBUS EQUITY
INCENTIVE
PLAN
(AS AMENDED AND RESTATED THROUGH AUGUST 11, 2020)
ARTICLE I
PURPOSE
The
purpose of this AzurRx BioPharma, Inc. 2020 Omnibus Equity
Incentive Plan as amended and restated (the “Plan”) is to benefit
AzurRx BioPharma, Inc., a Delaware corporation (the
“Company”) and its
shareholders, by assisting the Company and its subsidiaries to
attract, retain and provide incentives to key management employees,
officers, directors, and consultants of the Company and its
Affiliates, and to align the interests of such service providers
with those of the Company’s shareholders. Accordingly, the
Plan provides for the granting of Non-qualified Stock Options,
Incentive Stock Options, Restricted Stock Awards, Restricted Stock
Unit Awards, Stock Appreciation Rights, Performance Stock Awards,
Performance Unit Awards, Unrestricted Stock Awards, Dividend
Equivalent Rights, Incentive Bonus Awards, Other Cash-Based Awards
and Other Stock-Based Awards or any combination of the
foregoing.
ARTICLE II
DEFINITIONS
The
following definitions shall be applicable throughout the Plan
unless the context otherwise requires:
2.1 “Affiliate” shall mean any
corporation which, with respect to the Company, is a
“subsidiary corporation” within the meaning of Section
424(f) of the Code or other entity in which the Company has a
controlling interest in such entity or another entity which is part
of a chain of entities in which the Company or each entity has a
controlling interest in another entity in the unbroken chain of
entities ending with the applicable entity.
2.2 “Award” shall mean,
individually or collectively, any Option, Restricted Stock Award,
Restricted Stock Unit Award, Performance Stock Award, Performance
Unit Award, Stock Appreciation Right, Dividend Equivalent Right,
Incentive Bonus Award, Other Cash-Based Award and Other Stock-Based
Award or Unrestricted Stock Award.
2.3 “Award Agreement” shall mean a
written agreement between the Company and the Holder with respect
to an Award, setting forth the terms and conditions of the Award,
as amended.
2.4 “Board” shall mean the
Board of Directors of the Company.
2.5 “Base Value” shall have
the meaning given to such term in Section 14.2.
-2-
2.6 “Cause” shall mean (i) if
the Holder is a party to an employment or service agreement with
the Company or an Affiliate which agreement defines
“Cause” (or a similar term), “Cause” shall have the
same meaning as provided for in such agreement, or (ii) for a
Holder who is not a party to such an agreement, “Cause” shall mean
termination by the Company or an Affiliate of the employment (or
other service relationship) of the Holder by reason of the
Holder’s (A) intentional failure to perform reasonably
assigned duties, (B) dishonesty or willful misconduct in the
performance of the Holder’s duties, (C) involvement in a
transaction which is materially adverse to the Company or an
Affiliate, (D) breach of fiduciary duty involving personal profit,
(E) willful violation of any law, rule, regulation or court order
(other than misdemeanor traffic violations and misdemeanors not
involving misuse or misappropriation of money or property), (F)
commission of an act of fraud or intentional misappropriation or
conversion of any asset or opportunity of the Company or an
Affiliate, (G) conviction of, or the entry of a plea of guilty or
no contest to, a felony or any other crime that causes the Company
or an Affiliates public disgrace or disrepute, or materially and
adversely affects the Company’s or an Affiliates’
operations or financial performance or the relationship the Company
has with its customer, (H) any breach of any obligation or duty to
the Company or any of its Affiliates (whether arising by statute,
common law or agreement) relating to confidentiality,
noncompetition, nonsolicitation or proprietary rights, or (I)
material breach of any provision of the Plan or the Holder’s
Award Agreement or any other written agreement between the Holder
and the Company or an Affiliate, in each case as determined in good
faith by the Board, the determination of which shall be final,
conclusive and binding on all parties.
2.7 “Change of Control” shall mean:
the satisfaction of any one or more of the following conditions
(and the “Change of Control” shall be deemed to have
occurred as of the first day that any one or more of the following
conditions shall have been satisfied):
(a) Any person (as such
term is used in paragraphs 13(d) and 14(d)(2) of the Exchange Act,
hereinafter in this definition, “Person”), other than the
Company or an Affiliate or an employee benefit plan of the Company
or an Affiliate, becomes the beneficial owner (as defined in Rule
13d-3 under the Exchange Act), directly or indirectly, of
securities of the Company representing more than fifty percent
(50%) of the combined voting power of the Company’s then
outstanding securities;
(b) The closing of a
merger, consolidation or other business combination (a
“Business
Combination”) other than a Business Combination in
which holders of the Shares immediately prior to the Business
Combination have substantially the same proportionate ownership of
the common stock or ordinary shares, as applicable, of the
surviving corporation immediately after the Business Combination as
immediately before;
(c) The closing of an
agreement for the sale or disposition of all or substantially all
(50% or more) of the Company’s assets to any entity that is
not an Affiliate;
(d) The approval by the
holders of Shares of a plan of complete liquidation of the Company,
other than a merger of the Company into any subsidiary or a
liquidation as a result of which persons who were shareholders of
the Company immediately prior to such liquidation have
substantially the same proportionate ownership of shares of common
stock or ordinary shares, as applicable, of the surviving
corporation immediately after such liquidation as immediately
before; or
-3-
(e) Within any
twenty-four (24) month period, the Incumbent Directors shall cease
to constitute at least a majority of the Board or the board of
directors of any successor to the Company; provided, however, that any director
elected to the Board, or nominated for election, by a majority of
the Incumbent Directors then still in office, shall be deemed to be
an Incumbent Director for purposes of this paragraph (e), but
excluding, for this purpose, any such individual whose initial
assumption of office occurs as a result of either an actual or
threatened election contest with respect to the election or removal
of directors or other actual or threatened solicitation of proxies
or consents by or on behalf of an individual, entity or
“group” other than the Board (including, but not
limited to, any such assumption that results from paragraphs (a),
(b), (c), or (d) of this definition).
Notwithstanding the
foregoing, no event or condition shall constitute a Change of
Control to the extent that, if it were, a penalty tax would be
imposed under Section 409A of the Code; provided that, in such a
case, the event or condition shall continue to constitute a Change
of Control to the maximum extent possible (e.g., if applicable, in
respect of vesting without an acceleration of distribution) without
causing the imposition of such penalty tax.
2.8 “Code” shall mean the
United States of America Internal Revenue Code of 1986, as amended.
Reference in the Plan to any section of the Code shall be deemed to
include any amendments or successor provisions to any section and
any regulation under such section.
2.9 “Committee” shall mean a
committee comprised of not less than two (2) members of the Board
who are selected by the Board as provided in Section
4.1.
2.10 “Company”
shall have the meaning given to such term in the introductory
paragraph, including any successor thereto.
2.11 “Consultant”
shall mean any non-Employee (individual) advisor to the Company or
an Affiliate who or which has contracted directly with the Company
or an Affiliate to render bona fide consulting or advisory services
thereto.
2.12 “Director”
shall mean a member of the Board or a member of the board of
directors of an Affiliate, in either case, who is not an
Employee.
2.13 “Dividend
Equivalent Right” shall mean an Award
granted under Article XIII of the Plan which entitles the Holder to
receive bookkeeping credits, cash payments and/or Share
distributions equal in amount to the distributions that would have
been made to the Holder had the Holder held a specified number of
Shares during the period the Holder held the Dividend Equivalent
Right.
2.14 “Dividend
Equivalent Right
Award Agreement” shall mean a
written agreement between the Company and a Holder with respect to
a Dividend Equivalent Right Award.
2.15 “Effective
Date” shall mean August 11, 2020.
2.16 “Employee”
shall mean any employee, including any officer, of the Company or
an Affiliate.
2.17 “Exchange
Act” shall mean the Securities Exchange Act of 1934,
as amended.
-4-
2.18 “Fair
Market Value” shall mean, as of any specified date,
the closing sales price of the Shares for such date (or, in the
event that the Shares are not traded on such date, on the
immediately preceding trading date) on the Nasdaq Stock Market or a
domestic or foreign national securities exchange (including
London’s Alternative Investment Market) on which the Shares
may be listed, as reported in The Wall Street Journal or The
Financial Times. If the Shares are not listed on the Nasdaq Stock
Market or on a national securities exchange, but are quoted on the
OTC Bulletin Board or by the National Quotation Bureau, the Fair
Market Value of the Shares shall be the mean of the highest bid and
lowest asked prices per Share for such date. If the Shares are not
quoted or listed as set forth above, Fair Market Value shall be
determined by the Board in good faith by any fair and reasonable
means (which means may be set forth with greater specificity in the
applicable Award Agreement). The Fair Market Value of property
other than Shares shall be determined by the Board in good faith by
any fair and reasonable means consistent with the requirements of
applicable law.
2.19 “Family
Member” of an individual shall mean any child,
stepchild, grandchild, parent, stepparent, spouse, former spouse,
sibling, niece, nephew, mother-in-law, father-in-law, son-in-law,
daughter-in-law, brother-in-law or sister-in-law, including
adoptive relationships, any person sharing the Holder’s
household (other than a tenant or employee of the Holder), a trust
in which such persons have more than fifty percent (50%) of the
beneficial interest, a foundation in which such persons (or the
Holder) control the management of assets, and any other entity in
which such persons (or the Holder) own more than fifty percent
(50%) of the voting interests.
2.20 “Holder”
shall mean an Employee, Director or Consultant who has been granted
an Award or any such individual’s beneficiary, estate or
representative, who has acquired such Award in accordance with the
terms of the Plan, as applicable.
2.21 “Incentive
Bonus Award” means an Award granted under Article XVI
of the Plan.
2.22 “Incentive
Stock Option” shall mean an Option which is intended
by the Committee to constitute an “incentive stock
option” and conforms to the applicable provisions of Section
422 of the Code.
2.23 “Incumbent
Director” shall mean, with respect to any period of
time specified under the Plan for purposes of determining whether
or not a Change of Control has occurred, the individuals who were
members of the Board at the beginning of such period.
2.24 “Non-qualified
Stock Option” shall mean an Option which is not an
Incentive Stock Option or which is designated as an Incentive Stock
Option but does not meet the applicable requirements of Section 422
of the Code.
2.25 “Option”
shall mean an Award granted under Article VII of the Plan of an
option to purchase Shares and shall include both Incentive Stock
Options and Non-qualified Stock Options.
2.26 “Option
Agreement” shall mean a
written agreement between the Company and a Holder with respect to
an Option.
2.27 “Other
Cash-Based Award” means a contractual right granted
under Article XV hereof entitling such Holder to receive a cash
payment at such times, and subject to such conditions, as are set
forth in the Plan and the applicable Other Cash-Based Award
Agreement.
-5-
2.28 “Other
Cash-Based Award Agreement” shall mean a
written agreement between the Company and a Holder with respect to
an Other Cash-Based Award.
2.29 “Other
Stock-Based Award” means a contractual right granted
under Article XV representing a notional unit interest equal in
value to a share of Common Stock to be paid and distributed at such
times, and subject to such conditions as are set forth in the Plan
and the applicable Other Stock-Based Award Agreement.
2.30 “Other
Stock-Based Award Agreement” shall mean a
written agreement between the Company and a Holder with respect to
an Other Stock-Based Award.
2.31 “Performance
Stock Award” or “Performance Stock” shall
mean an Award granted under Article XII of the Plan.
2.32 “Performance
Stock Agreement” shall mean a
written agreement between the Company and a Holder with respect to
a Performance Stock Award.
2.33 “Performance
Unit” shall mean a Unit awarded to a Holder pursuant
to a Performance Unit Award.
2.34 “Performance
Unit Award” shall mean an Award granted under Article
XI of the Plan.
2.35 “Performance
Unit Agreement” shall mean a
written agreement between the Company and a Holder with respect to
a Performance Unit Award.
2.36 “Plan”
shall mean this AzurRx BioPharma, Inc. 2020 Omnibus Equity
Incentive Plan initially adopted on July 23, 2020, as amended and
restated through the Effective Date, and as may be further amended
from time to time, together with each of the Award Agreements
utilized hereunder.
2.37 “Reporting
Person” shall mean an officer, director or greater
than ten percent stockholder of the Company within the meaning of
Rule 16a-2 under the Exchange Act, who is required to file reports
pursuant to Rule 16a-3 under the Exchange Act.
2.38 “Restricted
Stock Award” and “Restricted Stock” shall
mean an Award granted under Article VIII of the Plan of Shares, the
transferability of which by the Holder is subject to
Restrictions.
2.39 “Restricted
Stock Agreement” shall mean a
written agreement between the Company and a Holder with respect to
a Restricted Stock Award.
2.40 “Restricted
Stock Unit Award” and “RSUs” shall refer to an
Award granted under Article X of the Plan under which, upon the
satisfaction of predetermined individual service-related vesting
requirements, a cash payment shall be made to the Holder, based on
the number of Units awarded to the Holder.
2.41 “Restricted
Stock Unit Agreement” shall mean a
written agreement between the Company and a Holder with respect to
a Restricted Stock Award.
-6-
2.42 “Restriction
Period” shall mean the period of time for which Shares
subject to a Restricted Stock Award shall be subject to
Restrictions, as set forth in the applicable Restricted Stock
Agreement.
2.43 “Restrictions”
shall mean the forfeiture, transfer and/or other restrictions
applicable to Shares awarded to an Employee, Director or Consultant
under the Plan pursuant to a Restricted Stock Award and set forth
in a Restricted Stock Agreement.
2.44 “Rule
16b-3” shall mean Rule 16b-3 promulgated by the
Securities and Exchange Commission under the Exchange Act, as such
may be amended from time to time, and any successor rule,
regulation or statute fulfilling the same or a substantially
similar function.
2.45 “Shares”
or “Stock” shall mean the
shares of the Company’s common stock, par value $0.0001 per
share.
2.46 “Stock
Appreciation Right” or
“SAR”
shall mean an Award granted under Article XIV of the Plan of a
right, granted alone or in connection with a related Option, to
receive a payment equal to the increase in value of a specified
number of Shares between the date of Award and the date of
exercise.
2.47 “Stock
Appreciation Right
Agreement” shall mean a
written agreement between the Company and a Holder with respect to
a Stock Appreciation Right.
2.48 “Tandem
Stock Appreciation Right” shall mean a Stock
Appreciation Right granted in connection with a related Option, the
exercise of some or all of which results in termination of the
entitlement to purchase some or all of the Shares under the related
Option, all as set forth in Article XIV.
2.49 “Ten
Percent Shareholder” shall mean an Employee who, at
the time an Option is granted to him or her, owns shares possessing
more than ten percent (10%) of the total combined voting power of
all classes of shares of the Company or of any parent corporation
or subsidiary corporation thereof (both as defined in Section 424
of the Code), within the meaning of Section 422(b)(6) of the
Code.
2.50 “Termination
of Service” shall mean a termination of a
Holder’s employment with, or status as a Director or
Consultant of, the Company or an Affiliate, as applicable, for any
reason, including, without limitation, Total and Permanent
Disability or death, except as provided in Section 6.4. In the
event Termination of Service shall constitute a payment event with
respect to any Award subject to Code Section 409A, Termination of
Service shall only be deemed to occur upon a “separation from
service” as such term is defined under Code Section 409A and
applicable authorities.
2.51 “Total
and Permanent Disability” shall mean an individual
being considered “disabled” within the meaning of Code
Section 409A and Treasury Regulation 1.409A-3(i)(4), as well as any
successor regulation or interpretation.
2.52 “Unit”
shall mean a bookkeeping unit, which represents such monetary
amount as shall be designated by the Committee in each Performance
Unit Agreement, or represents one Share for purposes of each
Restricted Stock Unit Award.
2.53 “Unrestricted
Stock Award” shall mean an Award granted under Article
IX of the Plan of Shares which are not subject to
Restrictions.
2.54 “Unrestricted
Stock Agreement” shall mean a
written agreement between the Company and a Holder with respect to
an Unrestricted Stock Award.
-7-
ARTICLE III
EFFECTIVE DATE OF
PLAN
The
Plan shall be effective as of the Effective Date.
ARTICLE IV
ADMINISTRATION
4.1 Composition of Committee. The
Plan shall be administered by the Board until such time that the
Committee is appointed by the Board, and shall at all times
thereafter be administered by the Committee. If necessary, in the
Board’s discretion, to comply with Rule 16b-3 under the
Exchange Act, the Committee shall consist solely of three (3) or
more Directors who are each (i) “non- employee
directors” within the meaning of Rule 16b-3
(“Non-Employee
Directors”) and (ii) “independent” for
purposes of any applicable listing requirements; provided, however, that the Board or the
Committee may delegate to a committee of one or more members of the
Board who are not Non-Employee Directors, the authority to grant
Awards to eligible persons who are not then subject to the
requirements of Section 16 of the Exchange Act. If a member of the
Committee shall be eligible to receive an Award under the Plan,
such Committee member shall have no authority hereunder with
respect to his or her own Award. If and to the extent permitted by
law, the Committee may authorize one or more Reporting Persons (or
other officers) to make Awards to Employees, Directors or
Consultants who are not Reporting Persons (or other officers whom
the Committee has specifically authorized to make Awards). Subject
to law and the restrictions set forth in the Plan, the Committee
may delegate administrative functions to individuals who are
Reporting Persons, officers, or employees of the Company.
4.2 Powers. Subject to the
provisions of the Plan, the Committee shall have the sole
authority, in its discretion, to make all determinations under the
Plan, including but not limited to determining which Employees,
Directors or Consultants shall receive an Award, the time or times
when an Award shall be made (the date of grant of an Award shall be
the date on which the Award is awarded by the Committee), what type
of Award shall be granted, the term of an Award, the date or dates
on which an Award vests (including acceleration of vesting), the
form of any payment to be made pursuant to an Award, the terms and
conditions of an Award (including the forfeiture of the Award
(and/or any financial gain) if the Holder of the Award violates any
applicable restrictive covenant thereof), the Restrictions under a
Restricted Stock Award and the number of Shares which may be issued
under an Award, performance goals applicable to any Award and
certification of the achievement of such goals, and the waiver of
any restrictions or performance goals, subject to compliance with
applicable laws, all as may be applicable. In making such
determinations the Committee may take into account the nature of
the services rendered by the respective Employees, Directors and
Consultants, their present and potential contribution to the
Company’s (or the Affiliate’s) success and such other
factors as the Committee in its discretion may deem
relevant.
4.3 Additional Powers. The
Committee shall have such additional powers as are delegated to it
under the other provisions of the Plan. Subject to the express
provisions of the Plan, the Committee is authorized to construe the
Plan and the respective Award Agreements executed hereunder, to
prescribe such rules and regulations relating to the Plan as it may
deem advisable to carry out the intent of the Plan, to determine
the terms, restrictions and provisions of each Award and to make
all other determinations necessary or advisable for administering
the Plan. The Committee may correct any defect or supply any
omission or reconcile any inconsistency in any Award Agreement in
the manner and to the extent the Committee shall deem necessary,
appropriate or expedient to carry it into effect. The
determinations of the Committee on the matters referred to in this
Article IV shall be conclusive and binding on the Company and all
Holders.
-8-
4.4 Committee Action. Subject to
compliance with all applicable laws, action by the Committee shall
require the consent of a majority of the members of the Committee,
expressed either orally at a meeting of the Committee or in writing
in the absence of a meeting. No member of the Committee shall have
any liability for any good faith action, inaction or determination
in connection with the Plan.
ARTICLE V
SHARES SUBJECT TO
PLAN AND LIMITATIONS THEREON
5.1 Authorized Shares and Award
Limits. The Committee may from time to time grant Awards to
one or more Employees, Directors and/or Consultants determined by
it to be eligible for participation in the Plan in accordance with
the provisions of Article VI. Subject to Article XVIII, the number
of Shares that may be issued under all Awards granted under the
Plan shall be 10,000,000 (the “Share Reserve”); provided
that, subject to Article XVIII, the Share Reserve (as adjusted as
set forth herein) shall automatically be increased, but not
decreased, on January 1 of each calendar year (beginning January 1,
2021) so as to be equal to ten percent (10%) of the issued and
outstanding shares of the Company’s common stock on December
31 of the preceding calendar year on an as converted basis (the
“As Converted
Shares”). Notwithstanding the foregoing, the Board may
in its discretion, determine that no increase in the Share Reserve
shall be made for any year or determine that a lesser number of
Shares shall be added to the Share Reserve than would otherwise
have been added pursuant to the preceding sentence. For calculation
purposes, the As Converted Shares shall include all shares of the
Company’s outstanding common stock and all shares of the
Company’s common stock issuable upon the conversion of
outstanding preferred stock, warrants and other convertible
securities, but shall not include any shares of common stock
issuable upon the exercise of options and other convertible
securities issued pursuant to the Plan or the Company’s
Amended and Restated 2014 Omnibus Equity Incentive Plan. Subject to
Article XVIII, the maximum number of Shares available for issuance
in respect of Incentive Stock Options is 15,000,000, but in no
event may Incentive Stock Options be granted in excess of the Share
Reserve as the same may be increased in accordance with the
foregoing provisions of this Section. To the extent that an Award
lapses, expires, is canceled, is terminated unexercised or ceases
to be exercisable for any reason, or the rights of its Holder
terminate, any Shares subject to such Award shall again be
available for the grant of a new Award. Shares that otherwise would
have been issued upon the exercise of an Option or Stock
Appreciation Right or in payment with respect to any other form of
Award, that are surrendered in payment or partial payment of the
exercise price thereof and/or taxes withheld with respect to the
exercise thereof or the making of such payment, will no longer be
counted against the foregoing maximum share limitations and may
again be made subject to Awards under the Plan pursuant to such
limitations.
5.2 Individual Holder
Limitations. Subject to adjustment as provided in
Article XVIII, the number of Shares with respect to which Awards
may be granted during any calendar year to any one Director who is
a non-employee director of the Board shall not exceed
250,000.
-9-
ARTICLE VI
ELIGIBILITY AND
TERMINATION OF SERVICE
6.1 Eligibility. Awards made under the
Plan may be granted solely to individuals who, at the time of
grant, are Employees, Directors or Consultants, or any other person
who is determined by the Committee to be a prospective Employee,
Director or Consultant; provided, that the Award for any grant to a
prospective Employee, Director or Consultant will contain
appropriate forfeiture provisions in the event such individual does
not become employed or engaged by the Company. An Award may be
granted on more than one occasion to the same Employee, Director or
Consultant, and, subject to the limitations set forth in the Plan,
such Award may include, a Non-qualified Stock Option, a Restricted
Stock Award, a Restricted Stock Unit Award, an Unrestricted Stock
Award, a Dividend Equivalent Right Award, a Performance Stock
Award, a Performance Unit Award, a Stock Appreciation Right, a
Tandem Stock Appreciation Right, an Incentive Bonus Award, an Other
Cash-Based Award, an Other Stock-Based Award or any combination
thereof, and solely for Employees, an Incentive Stock Option. The
Committee shall determine the terms and conditions of all Awards in
accordance with its authority under Article IV.
6.2 Termination of Service. Except
to the extent inconsistent with the terms of the applicable Award
Agreement and/or the provisions of Sections 6.3 or 6.4, the
following terms and conditions shall apply with respect to a
Holder’s Termination of Service with the Company or an
Affiliate, as applicable:
(i) The Holder’s
rights, if any, to exercise any then exercisable Options and/or
Stock Appreciation Rights shall terminate:
(A) If such termination
is for a reason other than the Holder’s Total and Permanent
Disability or death, ninety (90) days after the date of such
Termination of Service;
(B) If such termination
is on account of the Holder’s Total and Permanent Disability,
one (1) year after the date of such Termination of Service;
or
(C) If such termination
is on account of the Holder’s death, one (1) year after the
date of the Holder’s death.
Upon
such applicable date the Holder (and such Holder’s estate,
designated beneficiary or other legal representative) shall forfeit
any rights or interests in or with respect to any such Options and
Stock Appreciation Rights. Notwithstanding the forgoing, the
Committee, in its sole discretion, may provide for a different time
period in the Award Agreement, or may extend the time period,
following a Termination of Service, during which the Holder has the
right to exercise any vested Non-qualified Stock Option or Stock
Appreciation Right, which time period may not extend beyond the
expiration date of the Award term.
(ii) In
the event of a Holder’s Termination of Service for any reason
prior to the actual or deemed satisfaction and/or lapse of the
Restrictions, vesting requirements, terms and conditions applicable
to a Restricted Stock Award, Incentive Bonus Award, Other
Cash-Based Award, Other Stock-Based Award and/or Restricted Stock
Unit Award, such Award shall immediately be canceled, and the
Holder (and such Holder’s estate, designated beneficiary or
other legal representative) shall forfeit any rights or interests
in and with respect to any such Award. Notwithstanding the
immediately preceding sentence, the Committee, in its sole
discretion, may determine, prior to or within thirty (30) days
after the date of such Termination of Service that all or a portion
of any such Holder’s Award shall not be so canceled and
forfeited.
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6.3 Special Termination Rule.
Except to the extent inconsistent with the terms of the applicable
Award Agreement, and notwithstanding anything to the contrary
contained in this Article VI, if a Holder’s employment with,
or status as a Director of, the Company or an Affiliate shall
terminate, and if, within ninety (90) days of such termination,
such Holder shall become a Consultant, such Holder’s rights
with respect to any Award or portion thereof granted thereto prior
to the date of such termination may be preserved, if and to the
extent determined by the Committee in its sole discretion, as if
such Holder had been a Consultant for the entire period during
which such Award or portion thereof had been outstanding. Should
the Committee effect such determination with respect to such
Holder, for all purposes of the Plan, such Holder shall not be
treated as if his or her employment or Director status had
terminated until such time as his or her Consultant status shall
terminate, in which case his or her Award, as it may have been
reduced in connection with the Holder’s becoming a
Consultant, shall be treated pursuant to the provisions of Section
6.2, provided, however, that any such Award which is intended to be
an Incentive Stock Option shall, upon the Holder’s no longer
being an Employee, automatically convert to a Non- qualified Stock
Option. Should a Holder’s status as a Consultant terminate,
and if, within ninety (90) days of such termination, such Holder
shall become an Employee or a Director, such Holder’s rights
with respect to any Award or portion thereof granted thereto prior
to the date of such termination may be preserved, if and to the
extent determined by the Committee in its sole discretion, as if
such Holder had been an Employee or a Director, as applicable, for
the entire period during which such Award or portion thereof had
been outstanding, and, should the Committee effect such
determination with respect to such Holder, for all purposes of the
Plan, such Holder shall not be treated as if his or her Consultant
status had terminated until such time as his or her employment with
the Company or an Affiliate, or his or her Director status, as
applicable, shall terminate, in which case his or her Award shall
be treated pursuant to the provisions of Section 6.2.
6.4 Termination for Cause.
Notwithstanding anything in this Article VI or elsewhere in the
Plan to the contrary, and unless a Holder’s Award Agreement
specifically provides otherwise, in the event of a Holder’s
Termination for Cause, all of such Holder’s then outstanding
Awards shall expire immediately and be forfeited in their entirety
upon such termination. A Holder may not vest in any Award nor
exercise any Option after such time he or she is notified of the
Company’s intention to termination his/her employment or
service for Cause.
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ARTICLE VII
OPTIONS
7.1 Option Period. The term of each
Option shall be as specified in the Option Agreement; provided, however, that except as set
forth in Section 7.3, no Option shall be exercisable after the
expiration of ten (10) years from the date of its
grant.
7.2 Limitations on Exercise of
Option. An Option shall be exercisable in whole or in such
installments and at such times as specified in the Option
Agreement.
7.3 Special Limitations on Incentive Stock
Options. To the extent that the aggregate Fair Market Value
(determined at the time the respective Incentive Stock Option is
granted) of Shares with respect to which Incentive Stock Options
are exercisable for the first time by an individual during any
calendar year under all plans of the Company and any parent
corporation or subsidiary corporation thereof (both as defined in
Section 424 of the Code) which provide for the grant of Incentive
Stock Options exceeds One Hundred Thousand Dollars ($100,000) (or
such other individual limit as may be in effect under the Code on
the date of grant), the portion of such Incentive Stock Options
that exceeds such threshold shall be treated as Non-qualified Stock
Options. The Committee shall determine, in accordance with
applicable provisions of the Code, Treasury Regulations and other
administrative pronouncements, which of a Holder’s Options,
which were intended by the Committee to be Incentive Stock Options
when granted to the Holder, will not constitute Incentive Stock
Options because of such limitation, and shall notify the Holder of
such determination as soon as practicable after such determination.
No Incentive Stock Option shall be granted to an Employee if, at
the time the Incentive Stock Option is granted, such Employee is a
Ten Percent Shareholder, unless (i) at the time such Incentive
Stock Option is granted the Option price is at least one hundred
ten percent (110%) of the Fair Market Value of the Shares subject
to the Incentive Stock Option, and (ii) such Incentive Stock Option
by its terms is not exercisable after the expiration of five (5)
years from the date of grant. No Incentive Stock Option shall be
granted more than ten (10) years from the earlier of the Effective
Date or date on which the Plan is approved by the Company’s
shareholders. The designation by the Committee of an Option as an
Incentive Stock Option shall not guarantee the Holder that the
Option will satisfy the applicable requirements for
“incentive stock option” status under Section 422 of
the Code. An Incentive Stock Option may only be granted to Employee
who is considered an employee under Treasury Regulation
§1.421-7(h) of the Company.
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7.4 Option Agreement. Each Option shall be
evidenced by an Option Agreement in such form and containing such
provisions not inconsistent with the provisions of the Plan as the
Committee from time to time shall approve, including, but not
limited to, provisions intended to qualify an Option as an
Incentive Stock Option. An Option Agreement may provide for the
payment of the Option price, in whole or in part, by the delivery
of a number of Shares (plus cash if necessary) that have been owned
by the Holder for at least six (6) months and having a Fair Market
Value equal to such Option price, or such other forms or methods as
the Committee may determine from time to time, in each case,
subject to such rules and regulations as may be adopted by the
Committee. Each Option Agreement shall, solely to the extent
inconsistent with the provisions of Sections 6.2, 6.3, and 6.4, as
applicable, specify the effect of Termination of Service on the
exercisability of the Option. The Committee may, in its discretion,
accelerate the vesting of an Option at any time. Moreover, without
limiting the generality of the foregoing, a Non-qualified Stock
Option Agreement may provide for a “cashless exercise”
of the Option, in whole or in part, by (a) establishing procedures
whereby the Holder, by a properly-executed written notice, directs
(i) an immediate market sale or margin loan as to all or a part of
Shares to which he is entitled to receive upon exercise of the
Option, pursuant to an extension of credit by the Company to the
Holder of the Option price, (ii) the delivery of the Shares from
the Company directly to a brokerage firm and (iii) the delivery of
the Option price from sale or margin loan proceeds from the
brokerage firm directly to the Company, or (b) reducing the number
of Shares to be issued upon exercise of the Option by the number of
such Shares having an aggregate Fair Market Value equal to the
Option price (or portion thereof to be so paid) as of the date of
the Option’s exercise. An Option Agreement may also include
provisions relating to: (i) subject to the provisions hereof,
accelerated vesting of Options, including but not limited to, upon
the occurrence of a Change of Control, (ii) tax matters (including
provisions covering any applicable Employee wage withholding
requirements) and (iii) any other matters not inconsistent with the
terms and provisions of the Plan that the Committee shall in its
sole discretion determine. The terms and conditions of the
respective Option Agreements need not be identical.
7.5 Option Price and Payment. The
price at which a Share may be purchased upon the exercise of an
Option shall be determined by the Committee; provided, however, that such
Option’s exercise price (i) shall not be less than the Fair
Market Value of a Share on the date such Option is granted (or 110%
of Fair Market Value for an Incentive Stock Option held by a Ten
Percent Shareholder, as provided in Section 7.3), and (ii) shall be
subject to adjustment as provided in Article XVIII. The Option or
portion thereof may be exercised by delivery of an irrevocable
notice of exercise to the Company. The exercise price for the
Option or portion thereof shall be paid in full in the manner
prescribed by the Committee as set forth in the Plan and the
applicable Option Agreement, which manner, with the consent of the
Committee, may include the withholding of Shares otherwise issuable
in connection with the exercise of the Option. Separate share
certificates shall be issued by the Company for those Shares
acquired pursuant to the exercise of an Incentive Stock Option and
for those Shares acquired pursuant to the exercise of a
Non-qualified Stock Option.
7.6 Shareholder Rights and Privileges. The Holder of an Option
shall be entitled to all the privileges and rights of a shareholder
of the Company solely with respect to such Shares as have been
purchased under the Option and for which share certificates have
been registered in the Holder’s name.
7.7 Options and Rights in Substitution for
Stock or Options Granted by Other Corporations. Options may
be granted under the Plan from time to time in substitution for
stock options held by individuals employed by entities who become
Employees, Directors or Consultants as a result of a merger or
consolidation of the employing entity with the Company or any
Affiliate, or the acquisition by the Company or an Affiliate of the
assets of the employing entity, or the acquisition by the Company
or an Affiliate of stock or shares of the employing entity with the
result that such employing entity becomes an
Affiliate.
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7.8 Disqualifying Dispositions. If
Shares acquired by exercise of an Incentive Stock Option are
disposed of within two (2) years following the date of grant
or one (1) year following the transfer of such shares to the
Holder upon exercise, the Holder shall, promptly following such
disposition, notify the Company in writing of the date and terms of
such disposition and provide such other information regarding the
disposition as the Company may reasonably require.
7.9 Prohibition Against Re-Pricing. Except to the
extent (i) approved in advance by holders of a majority of the
shares of the Company entitled to vote generally in the election of
directors, or (ii) as a result of any Change of Control or any
adjustment as provided in Article XVIII, the Committee shall not
have the power or authority to reduce, whether through amendment or
otherwise, the exercise price under any outstanding Option or Stock
Appreciation Right, or to grant any new Award or make any payment
of cash in substitution for or upon the cancellation of Options
and/or Stock Appreciation Rights previously granted.
ARTICLE VIII
RESTRICTED STOCK
AWARDS
8.1 Award. A Restricted Stock Award
shall constitute an Award of Shares to the Holder as of the date of
the Award which are subject to a “substantial risk of
forfeiture” as defined under Section 83 of the Code during
the specified Restriction Period. At the time a Restricted Stock
Award is made, the Committee shall establish the Restriction Period
applicable to such Award. Each Restricted Stock Award may have a
different Restriction Period, in the discretion of the
Committee.
8.2 Terms and Conditions. At the
time any Award is made under this Article VIII, the Company and the
Holder shall enter into a Restricted Stock Agreement setting forth
each of the matters contemplated thereby and such other matters as
the Committee may determine to be appropriate. Shares awarded
pursuant to a Restricted Stock Award shall be represented by a
share certificate registered in the name of the Holder of such
Restricted Stock Award. If provided for under the Restricted Stock
Agreement, the Holder shall have the right to vote Shares subject
thereto and to enjoy all other shareholder rights, including the
entitlement to receive dividends on the Shares during the
Restriction Period, except that (i) the Holder shall not be
entitled to delivery of the share certificate until the Restriction
Period shall have expired, (ii) the Company shall retain custody of
the share certificate during the Restriction Period (with a share
power endorsed by the Holder in blank), (iii) the Holder may not
sell, transfer, pledge, exchange, hypothecate or otherwise dispose
of the Shares during the Restriction Period and (iv) a breach of
the terms and conditions established by the Committee pursuant to
the Restricted Stock Agreement shall cause a forfeiture of the
Restricted Stock Award. At the time of such Award, the Committee
may, in its sole discretion, prescribe additional terms and
conditions or restrictions relating to Restricted Stock Awards,
including, but not limited to, rules pertaining to the effect of
Termination of Service prior to expiration of the Restriction
Period. Such additional terms, conditions or restrictions shall, to
the extent inconsistent with the provisions of Sections 6.2, 6.3
and 6.4, as applicable, be set forth in a Restricted Stock
Agreement made in conjunction with the Award. The Committee may
subject the grant of any Restricted Stock Award to the execution of
a voting agreement with the Company. Such Restricted Stock
Agreement may also include provisions relating to: (i) subject to
the provisions hereof, accelerated vesting of Awards, including but
not limited to accelerated vesting upon the occurrence of a Change
of Control, (ii) tax matters (including provisions covering any
applicable Employee wage withholding requirements) and (iii) any
other matters not inconsistent with the terms and provisions of the
Plan that the Committee shall in its sole discretion determine. The
terms and conditions of the respective Restricted Stock Agreements
need not be identical. All Shares delivered to a Holder as part of
a Restricted Stock Award shall be delivered and reported by the
Company or the Affiliate, as applicable, to the Holder at the time
of vesting. The Committee may, in its discretion, accelerate the
vesting of a Restricted Stock Award.
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8.3 Payment for Restricted Stock. The
Committee shall determine the amount and form of any payment from a
Holder for Shares received pursuant to a Restricted Stock Award, if
any, provided that in the absence of such a determination, a Holder
shall not be required to make any payment for Shares received
pursuant to a Restricted Stock Award, except to the extent
otherwise required by law.
8.4 Section 83(b) Election. If a
Holder makes an election pursuant to Section 83(b) of the Code with
respect to a Restricted Stock Award, the Holder shall file, within
30 days following the date of grant, a copy of such election with
the Company (directed to the Secretary thereof) and with the
Internal Revenue Service, in accordance with the regulations under
Section 83 of the Code. The Committee may provide in an Award
Agreement that the Restricted Stock Award is conditioned upon the
Holder’s making or refraining from making an election with
respect to the Award under Section 83(b) of the Code.
ARTICLE IX
UNRESTRICTED STOCK
AWARDS
9.1 Award. Shares may be awarded
(or sold) to Employees, Directors or Consultants under the Plan
which are not subject to Restrictions of any kind, in consideration
for past services rendered thereby to the Company or an Affiliate
or for other valid consideration.
9.2 Terms and Conditions. At the
time any Award is made under this Article IX, the Company and the
Holder shall enter into an Unrestricted Stock Agreement setting
forth each of the matters contemplated hereby and such other
matters as the Committee may determine to be
appropriate.
9.3 Payment for Unrestricted Stock.
The Committee shall determine the amount and form of any payment
from a Holder for Shares received pursuant to an Unrestricted Stock
Award, if any, provided that in the absence of such a
determination, a Holder shall not be required to make any payment
for Shares received pursuant to an Unrestricted Stock Award, except
to the extent otherwise required by law.
ARTICLE X
RESTRICTED STOCK
UNIT AWARDS
10.1 Award.
A Restricted Stock Unit Award shall constitute a promise to grant
Shares (or cash equal to the Fair Market Value of Shares) to the
Holder at the end of a specified Restriction Period. At the time a
Restricted Stock Unit Award is made, the Committee shall establish
the Restriction Period applicable to such Award. Each Restricted
Stock Unit Award may have a different Restriction Period, in the
discretion of the Committee. A Restricted Stock Unit shall not
constitute an equity interest in the Company and shall not entitle
the Holder to voting rights, dividends or any other rights
associated with ownership of Shares prior to the time the Holder
shall receive a distribution of Shares pursuant to Section
10.3.
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10.2 Terms
and Conditions. At the time any Award is made under this
Article X, the Company and the Holder shall enter into a Restricted
Stock Unit Agreement setting forth each of the matters contemplated
thereby and such other matters as the Committee may determine to be
appropriate. The Restricted Stock Unit Agreement shall set forth
the individual service-based vesting requirement which the Holder
would be required to satisfy before the Holder would become
entitled to distribution pursuant to Section 10.3 and the number of
Units awarded to the Holder. Such conditions shall be sufficient to
constitute a “substantial risk of forfeiture” as such
term is defined under Section 409A of the Code. At the time of such
Award, the Committee may, in its sole discretion, prescribe
additional terms and conditions or restrictions relating to
Restricted Stock Unit Awards in the Restricted Stock Unit
Agreement, including, but not limited to, rules pertaining to the
effect of Termination of Service prior to expiration of the
applicable vesting period. The Committee may, in its discretion,
accelerate the vesting of a Restricted Stock Unit at any time. The
terms and conditions of the respective Restricted Stock Unit
Agreements need not be identical.
ARTICLE XI
PERFORMANCE UNIT
AWARDS
11.1 Award.
A Performance Unit Award shall constitute an Award under which,
upon the satisfaction of predetermined individual and/or Company
(and/or Affiliate) performance goals, a cash payment shall be made
to the Holder, based on the number of Units awarded to the Holder.
Performance Unit Award shall not constitute an equity interest in
the Company and shall not entitle the Holder to voting rights,
dividends or any other rights associated with ownership of
Shares.
11.2 Terms
and Conditions. At the time any Award is made under this
Article XI, the Company and the Holder shall enter into a
Performance Unit Agreement setting forth each of the matters
contemplated thereby and such other matters as the Committee may
determine to be appropriate. The Committee shall set forth in the
applicable Performance Unit Agreement the performance goals which
the Holder and/or the Company would be required to satisfy before
the Holder would become entitled to payment pursuant to Section
11.3, the number of Units awarded to the Holder and the dollar
value or formula assigned to each such Unit. Such payment shall be
subject to a “substantial risk of forfeiture” under
Section 409A of the Code. At the time of such Award, the Committee
may, in its sole discretion, prescribe additional terms and
conditions or restrictions relating to Performance Unit Awards,
including, but not limited to, rules pertaining to the effect of
Termination of Service prior to expiration of the applicable
performance period. The terms and conditions of the respective
Performance Unit Agreements need not be identical.
ARTICLE XII
PERFORMANCE STOCK
AWARDS
12.1 Award.
A Performance Stock Award shall constitute a promise to grant
Shares (or cash equal to the Fair Market Value of Shares) to the
Holder subject to achievement of specified performance goal. The
Committee shall establish the performance goals for the Performance
Stock Award, in its sole discretion. A Performance Stock Award
shall not constitute an equity interest in the Company and shall
not entitle the Holder to voting rights, dividends or any other
rights associated with ownership of Shares unless and until the
Holder shall receive a distribution of Shares pursuant to Section
12.3.
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12.2 Terms
and Conditions. At the time any Award is made under this
Article XII, the Company and the Holder shall enter into a
Performance Stock Agreement setting forth each of the matters
contemplated thereby and such other matters as the Committee may
determine to be appropriate. The Committee shall set forth in the
applicable Performance Stock Agreement the performance goals which
the Holder and/or the Company would be required to satisfy before
the Holder would become entitled to the receipt of Shares pursuant
to such Holder’s Performance Stock Award and the number of
Shares subject to such Performance Stock Award. Such distribution
shall be subject to a “substantial risk of forfeiture”
under Section 409A of the Code. If such performance goals are
achieved, the distribution of Shares (or the payment of cash, as
determined in the sole discretion of the Committee), shall be made
no later than by the fifteenth (15th) day of the third (3rd)
calendar month next following the end of the Company’s fiscal
year to which such goals and objectives relate. At the time of such
Award, the Committee may, in its sole discretion, prescribe
additional terms and conditions or restrictions relating to
Performance Stock Awards, including, but not limited to, rules
pertaining to the effect of the Holder’s Termination of
Service prior to the expiration of the applicable performance
period. The terms and conditions of the respective Performance
Stock Agreements need not be identical.
ARTICLE XIII
DIVIDEND EQUIVALENT
RIGHTS
13.1 Award.
A Dividend Equivalent Right shall entitle the Holder to receive
bookkeeping credits, cash payments and/or Share distributions equal
in amount to the distributions that would have been made to the
Holder had the Holder held a specified number of Shares during the
specified period of the Award.
13.2 Terms
and Conditions. At the time any Award is made under this
Article XIII, the Company and the Holder shall enter into a
Dividend Equivalent Rights Award Agreement setting forth each of
the matters contemplated thereby and such other matters as the
Committee may determine to be appropriate. The Committee shall set
forth in the applicable Dividend Equivalent Rights Award Agreement
the terms and conditions, if any, including whether the Holder is
to receive credits currently in cash, is to have such credits
reinvested (at Fair Market Value determined as of the date of
reinvestment) in additional Shares or is to be entitled to choose
among such alternatives. Such receipt shall be subject to a
“substantial risk of forfeiture” under Section 409A of
the Code and, if such Award becomes vested, the distribution of
such cash or Shares shall be made no later than by the fifteenth
(15th) day of the third (3rd) calendar month next following the end
of the Company’s fiscal year in which the Holder’s
interest in the Award vests. Dividend Equivalent Rights Awards may
be settled in cash or in Shares, as set forth in the applicable
Dividend Equivalent Rights Award Agreement. A Dividend Equivalent
Rights Award may, but need not be, awarded in tandem with another
Award (other than an Option or a SAR), whereby, if so awarded, such
Dividend Equivalent Rights Award shall expire, terminate or be
forfeited by the Holder, as applicable, under the same conditions
as under such other Award.
13.3 Interest
Equivalents. The Dividend Equivalent Rights Award Agreement
for a Dividend Equivalent Rights Award may provide for the
crediting of interest on a Dividend Rights Award to be settled in
cash at a future date (but in no event later than by the fifteenth
(15th) day of the third (3rd) calendar month next following the end
of the Company’s fiscal year in which such interest is
credited and vested), at a rate set forth in the applicable
Dividend Equivalent Rights Award Agreement, on the amount of cash
payable thereunder.
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ARTICLE XIV
STOCK APPRECIATION
RIGHTS
14.1 Award.
A Stock Appreciation Right shall constitute a right, granted alone
or in connection with a related Option, to receive a payment equal
to the increase in value of a specified number of Shares between
the date of Award and the date of exercise.
14.2 Terms
and Conditions. At the time any Award is made under this
Article XIV, the Company and the Holder shall enter into a Stock
Appreciation Right Agreement setting forth each of the matters
contemplated thereby and such other matters as the Committee may
determine to be appropriate. The Committee shall set forth in the
applicable Stock Appreciation Right Agreement the terms and
conditions of the Stock Appreciation Right, including (i) the base
value (the “Base
Value”) for the Stock Appreciation Right, which shall
be not less than the Fair Market Value of an Share on the date of
grant of the Stock Appreciation Right, (ii) the number of Shares
subject to the Stock Appreciation Right, (iii) the period during
which the Stock Appreciation Right may be exercised; provided, however, that no Stock
Appreciation Right shall be exercisable after the expiration of ten
(10) years from the date of its grant, and (iv) any other special
rules and/or requirements which the Committee imposes upon the
Stock Appreciation Right. Upon the exercise of some or all of the
portion of a Stock Appreciation Right, the Holder shall receive a
payment from the Company, in cash or in the form of Shares having
an equivalent Fair Market Value or in a combination of both, as
determined in the sole discretion of the Committee, equal to the
product of:
(a) The excess of (i)
the Fair Market Value of an Share on the date of exercise, over
(ii) the Base Value, multiplied by,
(b) The number of
Shares with respect to which the Stock Appreciation Right is
exercised.
14.3 Tandem
Stock Appreciation Rights. If the Committee grants a
Stock Appreciation Right which is intended to be a Tandem Stock
Appreciation Right, the Tandem Stock Appreciation Right shall be
granted at the same time as the related Option, and the following
special rules shall apply:
(a) The Base Value
shall be equal to or greater than the per Share exercise price
under the related Option;
(b) The Tandem Stock
Appreciation Right may be exercised for all or part of the Shares
which are subject to the related Option, but solely upon the
surrender by the Holder of the Holder’s right to exercise the
equivalent portion of the related Option (and when a Share is
purchased under the related Option, an equivalent portion of the
related Tandem Stock Appreciation Right shall be
canceled);
(c) The Tandem Stock
Appreciation Right shall expire no later than the date of the
expiration of the related Option;
(d) The value of the
payment with respect to the Tandem Stock Appreciation Right may be
no more than one hundred percent (100%) of the difference between
the per Share exercise price under the related Option and the Fair
Market Value of the Shares subject to the related Option at the
time the Tandem Stock Appreciation Right is exercised, multiplied
by the number of the Shares with respect to which the Tandem Stock
Appreciation Right is exercised; and
(e) The Tandem Stock
Appreciation Right may be exercised solely when the Fair Market
Value of the Shares subject to the related Option exceeds the per
Share exercise price under the related Option.
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ARTICLE XV
OTHER CASH-BASED AWARDS AND OTHER STOCK-BASED AWARDS
Section 15.1
Other Cash-Based and
Stock-Based Awards. The Committee may grant other types of
equity-based or equity-related Awards not otherwise described by
the terms of this Plan (including the grant or offer for sale of
unrestricted Shares) in such amounts and subject to such terms and
conditions, as the Committee shall determine. Such Awards may
involve the transfer of Shares to a Holder, or payment in cash or
otherwise of amounts based on the value of Shares. In addition, the
Committee, at any time and from time to time, may grant Cash-Based
Awards to a Holder in such amounts and upon such terms as the
Committee shall determine, in its sole discretion.
Section 15.2
Value of Cash-Based Awards
and Other Stock-Based Awards. Each Other Stock-Based Award
shall be expressed in terms of Shares or units based on Shares, as
determined by the Committee, in its sole discretion. Each Other
Cash-Based Award shall specify a payment amount or payment range as
determined by the Committee, in its sole discretion. If the
Committee exercises its discretion to establish performance goals,
the value of Other Cash-Based Awards that shall be paid to the
Holder will depend on the extent to which such performance goals
are met.
Section 15.3
Payment of Cash-Based
Awards and Other Stock-Based Awards. Payment, if any, with
respect to Other Cash-Based Awards and Other Stock-Based Award
shall be made in accordance with the terms of the Award, in cash or
Shares as the Committee determines.
ARTICLE
XVI
INCENTIVE BONUS AWARDS
Section 16.1
Incentive Bonus
Awards. The Committee, at its discretion, may grant
Incentive Bonus Awards to such Employees, Directors or Consultants
as it may designate from time to time. The terms of a
Holder’s Incentive Bonus Award shall be set forth in the
Holder’s Award Agreement. Each Award Agreement shall specify
such general terms and conditions as the Committee shall
determine.
Section 16.2
Incentive Bonus Award
Performance Criteria. The determination of Incentive Bonus
Awards for a given year or years may be based upon the attainment
of specified levels of Company performance as measured by
pre-established, objective performance criteria determined at the
discretion of the Committee. The Committee shall (i) select those
Employees, Directors or Consultants who shall be eligible to
receive an Incentive Bonus Award, (ii) determine the performance
period, (iii) determine target levels of performance, and (iv)
determine the level of Incentive Bonus Award to be paid to each
selected Employee, Director or Consultant upon the achievement of
each performance level. The Committee generally shall make the
foregoing determinations prior to the commencement of services to
which an Incentive Bonus Award relates, to the extent applicable,
and while the outcome of the performance goals and targets is
uncertain.
Section 16.3
Payment of
Incentive Bonus
Awards.
(a)
Incentive Bonus Awards shall be paid in cash or Shares, as set
forth in a Holder’s Award Agreement. Payments shall be made
following a determination by the Committee that the performance
targets were attained and shall be made within two and one-half
months after the later of the end of the fiscal or calendar year in
which the Incentive Award is no longer subject to a substantial
risk of forfeiture.
(b) The
amount of an Incentive Bonus Award to be paid upon the attainment
of each targeted level of performance shall equal a percentage of a
Holder’s base salary for the fiscal year, a fixed dollar
amount, or such other formula, as determined by the
Committee.
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ARTICLE XVII
CHANGE OF CONTROL
Section 17.1
Effect of Change of
Control.
(a) The
Committee may, at the time of the grant of an Award and as set
forth in an Award Agreement, provide for the effect of a
“Change of Control” on an Award. Such provisions may
include any one or more of the following: (i) the acceleration
or extension of time periods for purposes of exercising, vesting
in, or realizing gain from any Award, (ii) the elimination or
modification of performance or other conditions related to the
payment or other rights under an Award, (iii) provision for
the cash settlement of an Award for an equivalent cash value, as
determined by the Committee, or (iv) such other modification
or adjustment to an Award as the Committee deems appropriate to
maintain and protect the rights and interests of Holders upon or
following a Change of Control. To the extent necessary for
compliance with Section 409A of the Code, an Award Agreement
shall provide that an Award subject to the requirements of
Section 409A that would otherwise become payable upon a Change
of Control shall only become payable to the extent that the
requirements for a “change in control” for purposes of
Section 409A have been satisfied.
(b) Notwithstanding
anything to the contrary set forth in the Plan, unless otherwise
provided by an Award Agreement, upon or in anticipation of any
Change of Control, the Committee may, in its sole and absolute
discretion and without the need for the consent of any Holder, take
one or more of the following actions contingent upon the occurrence
of that Change of Control: (i) cause any or all outstanding
Stock Options and Stock Appreciation Rights held by Holders
affected by the Change of Control to become vested and immediately
exercisable, in whole or in part; (ii) cause any or all
outstanding Restricted Stock Awards, Restricted Stock Unit Awards,
Performance Stock Awards, Performance Units Awards, Unrestricted
Stock Awards, Incentive Bonus Award and any other Award held by
Holders affected by the Change of Control to become
non-forfeitable, in whole or in part; (iii) cancel any Stock
Option or Stock Appreciation Right in exchange for a substitute
option in a manner consistent with the requirements of Treasury
Regulation. §1.424-1(a) or §1.409A-1(b)(5)(v)(D), as
applicable (notwithstanding the fact that the original Stock Option
may never have been intended to satisfy the requirements for
treatment as an Incentive Stock Option); (iv) cancel any
Restricted Stock Award, Restricted Stock Units Awards, Performance
Stock Award or Performance Unit Award held by a Holder in exchange
for restricted stock or performance shares of or stock or
performance units in respect of the capital stock of any successor
corporation; (v) redeem any Restricted Stock Award held by a
Holder affected by the Change of Control for cash and/or other
substitute consideration with a value equal to the Fair Market
Value of an unrestricted Share on the date of the Change of
Control; (vi) terminate any Award in exchange for an amount of
cash and/or property equal to the amount, if any, that would have
been attained upon the exercise of such Award or realization of the
Holder’s rights as of the date of the occurrence of the
Change of Control (the “Change of Control
Consideration”); provided, however that if the Change of
Control Consideration with respect to any Option or Stock
Appreciation Right does not exceed the exercise price of such
Option or Stock Appreciation Right, the Committee may cancel the
Option or Stock Appreciation Right without payment of any
consideration therefor. Any such Change of Control Consideration
may be subject to any escrow, indemnification and similar
obligations, contingencies and encumbrances applicable in
connection with the Change of Control to holders of Shares. Without
limitation of the foregoing, if as of the date of the occurrence of
the Change of Control the Committee determines that no amount would
have been attained upon the realization of the Holder’s
rights, then such Award may be terminated by the Company without
payment. The Committee may cause the Change of Control
Consideration to be subject to vesting conditions (whether or not
the same as the vesting conditions applicable to the Award prior to
the Change of Control) and/or make such other modifications,
adjustments or amendments to outstanding Awards or this Plan as the
Committee deems necessary or appropriate.
-20-
(c) The
Committee may require a Holder to (i) represent and warrant as to
the unencumbered title to the Holder’s Awards, (ii) bear such
Holder’s pro rata share of any post-closing indemnity
obligations, and be subject to the same or similar post-closing
purchase price adjustments, escrow terms, offset rights, holdback
terms and similar conditions as the other holders of Shares, and
(iii) execute and deliver such documents and instruments as the
Committee may reasonably require for the Holder to be bound by such
obligations. The Committee will endeavor to take action under this
Section 17 in a manner that does not cause a violation of Section
409A of the Code with respect to an Award.
ARTICLE XVIII
RECAPITALIZATION OR
REORGANIZATION
18.1 Adjustments
to Shares. The shares with respect to which Awards may be
granted under the Plan are Shares as presently constituted;
provided,
however, that if,
and whenever, prior to the expiration or distribution to the Holder
of Shares underlying an Award theretofore granted, the Company
shall effect a subdivision or consolidation of the Shares or the
payment of an Share dividend on Shares without receipt of
consideration by the Company, the number of Shares with respect to
which such Award may thereafter be exercised or satisfied, as
applicable, (i) in the event of an increase in the number of
outstanding Shares, shall be proportionately increased, and the
purchase price per Share shall be proportionately reduced, and (ii)
in the event of a reduction in the number of outstanding Shares,
shall be proportionately reduced, and the purchase price per Share
shall be proportionately increased. Notwithstanding the foregoing
or any other provision of this Article XVIII, any adjustment made
with respect to an Award (x) which is an Incentive Stock Option,
shall comply with the requirements of Section 424(a) of the Code,
and in no event shall any adjustment be made which would render any
Incentive Stock Option granted under the Plan to be other than an
“incentive stock option” for purposes of Section 422 of
the Code, and (y) which is a Non-qualified Stock Option, shall
comply with the requirements of Section 409A of the Code, and in no
event shall any adjustment be made which would render any
Non-qualified Stock Option granted under the Plan to become subject
to Section 409A of the Code.
18.2 Recapitalization.
If the Company recapitalizes or otherwise changes its capital
structure, thereafter upon any exercise or satisfaction, as
applicable, of a previously granted Award, the Holder shall be
entitled to receive (or entitled to purchase, if applicable) under
such Award, in lieu of the number of Shares then covered by such
Award, the number and class of shares and securities to which the
Holder would have been entitled pursuant to the terms of the
recapitalization if, immediately prior to such recapitalization,
the Holder had been the holder of record of the number of Shares
then covered by such Award.
18.3 Other
Events. In the event of changes to the outstanding Shares by
reason of an extraordinary cash dividend, reorganization, merger,
consolidation, combination, split-up, spin-off, exchange or other
relevant change in capitalization occurring after the date of the
grant of any Award and not otherwise provided for under this
Article XVIII, any outstanding Awards and any Award Agreements
evidencing such Awards shall be adjusted by the Board in its
discretion in such manner as the Board shall deem equitable or
appropriate taking into consideration the applicable accounting and
tax consequences, as to the number and price of Shares or other
consideration subject to such Awards. In the event of any
adjustment pursuant to Sections 18.1, 18.2 or this Section 18.3,
the aggregate number of Shares available under the Plan pursuant to
Section 5.1 may be appropriately adjusted by the Board, the
determination of which shall be conclusive. In addition, the
Committee may make provision for a cash payment to a Holder or a
person who has an outstanding Award. The number of Shares subject
to any Award shall be rounded to the nearest whole
number.
-21-
18.4 Powers
Not Affected. The existence of the Plan and the Awards
granted hereunder shall not affect in any way the right or power of
the Board or of the shareholders of the Company to make or
authorize any adjustment, recapitalization, reorganization or other
change of the Company’s capital structure or business, any
merger or consolidation of the Company, any issue of debt or equity
securities ahead of or affecting Shares or the rights thereof, the
dissolution or liquidation of the Company or any sale, lease,
exchange or other disposition of all or any part of its assets or
business or any other corporate act or proceeding.
18.5 No
Adjustment for
Certain Awards. Except as hereinabove expressly provided,
the issuance by the Company of shares of any class or securities
convertible into shares of any class, for cash, property, labor or
services, upon direct sale, upon the exercise of rights or warrants
to subscribe therefor or upon conversion of shares or obligations
of the Company convertible into such shares or other securities,
and in any case whether or not for fair value, shall not affect
previously granted Awards, and no adjustment by reason thereof
shall be made with respect to the number of Shares subject to
Awards theretofore granted or the purchase price per Share, if
applicable.
ARTICLE XIX
AMENDMENT AND
TERMINATION OF PLAN
The
Plan shall continue in effect, unless sooner terminated pursuant to
this Article XIX, until the tenth (10th) anniversary of the date on
which it is adopted by the Board (except as to Awards outstanding
on that date) (the “Expiration Date”). The Board in its
discretion may terminate the Plan at any time with respect to any
shares for which Awards have not theretofore been granted;
provided,
however, that the
Plan’s termination shall not materially and adversely impair
the rights of a Holder with respect to any Award theretofore
granted without the consent of the Holder. The Board shall have the
right to alter or amend the Plan or any part hereof from time to
time; provided that (a) to the extent necessary and desirable to
comply with any applicable law, regulation, or stock exchange rule,
the Company shall obtain stockholder approval of any Plan amendment
in such a manner and to such a degree as required, and (b)
stockholder approval is required for any amendment to the Plan that
(i) increases the aggregate number of Shares available for issuance
under the Plan (other than any automatic increases to the Share
Reserve in accordance with Section 5.1), or (ii) changes the
persons or class of persons eligible to receive Awards. Subject to
the terms of the Plan, the Committee shall have the authority to
amend the terms of an Award in any manner that is not inconsistent
with the Plan (including to extend the post-termination
exercisability period of Options and Stock Appreciation Rights),
provided that no such action (except an action relating to a Change
of Control) shall materially and adversely impair the rights of a
Holder with respect to an outstanding Award without the
Holder’s consent. For purposes of the foregoing, any action
of the Board or the Committee that alters or affects the tax
treatment of any Award shall not be considered to materially and
adversely impair any rights of any Holder.
-22-
ARTICLE XX
MISCELLANEOUS
20.1 No
Right to
Award. Neither the adoption of the Plan by the Company nor
any action of the Board or the Committee shall be deemed to give an
Employee, Director or Consultant any right to an Award except as
may be evidenced by an Award Agreement duly executed on behalf of
the Company, and then solely to the extent and on the terms and
conditions expressly set forth therein.
20.2 Substitute
Awards in Corporate Transactions. Nothing contained in the
Plan shall be construed to limit the right of the Committee to
grant Awards under the Plan in connection with the acquisition,
whether by purchase, merger, consolidation or other corporate
transaction, of the business or assets of any corporation or other
entity. Without limiting the foregoing, the Committee may grant
Awards under the Plan to an employee or director of another
corporation who becomes an Employee, Director or Consultant by
reason of any such corporate transaction in substitution for Awards
previously granted by such corporation or entity to such person.
The terms and conditions of the substitute Awards may vary from the
terms and conditions that would otherwise be required by the Plan
solely to the extent the Committee deems necessary for such
purpose. Any Shares subject to these substitute Awards shall not be
counted against any of the maximum share limitations set forth in
the Plan.
20.3 Stock
Certificates; Book Entry Form. Notwithstanding any provision
of the Plan to the contrary, unless otherwise determined by the
Committee or required by any applicable law, rule or regulation,
any obligation set forth in the Plan pertaining to the delivery or
issuance of stock certificates evidencing Shares may be satisfied
by having issuance and/or ownership of such shares recorded on the
books and records of the Company (or, as applicable, its transfer
agent or stock plan administrator).
20.4 No
Guarantee of Tax Consequences. Neither the Company, the
Board, the Committee nor any other person make any commitment or
guarantee that any federal, state, local or foreign tax treatment
will apply or be available to any Holder or any other person
hereunder.
20.5 No
Rights
Conferred. Nothing contained in the Plan shall (i) confer
upon any Employee any right with respect to continuation of
employment with the Company or any Affiliate, (ii) interfere in any
way with any right of the Company or any Affiliate to terminate the
employment of an Employee at any time, (iii) confer upon any
Director any right with respect to continuation of such
Director’s membership on the Board, (iv) interfere in any way
with any right of the Company or an Affiliate to terminate a
Director’s membership on the Board at any time, (v) confer
upon any Consultant any right with respect to continuation of his
or her consulting engagement with the Company or any Affiliate, or
(vi) interfere in any way with any right of the Company or an
Affiliate to terminate a Consultant’s consulting engagement
with the Company or an Affiliate at any time.
-23-
20.6 Other
Laws; No Fractional Shares; Withholding. The Company shall
not be obligated by virtue of any provision of the Plan to
recognize the exercise of any Award or to otherwise sell or issue
Shares in violation of any laws, rules or regulations, and any
postponement of the exercise or settlement of any Award under this
provision shall not extend the term of such Award. Neither the
Company nor its directors or officers shall have any obligation or
liability to a Holder with respect to any Award (or Shares issuable
thereunder) (i) that shall lapse because of such postponement, or
(ii) for any failure to comply with the requirements of any
applicable law, rules or regulations, including but not limited to
any failure to comply with the requirements of Section 409A of this
Code. No fractional Shares shall be delivered, nor shall any cash
in lieu of fractional Shares be paid. The Company shall have the
right to deduct in cash (whether under this Plan or otherwise) in
connection with all Awards any taxes required by law to be withheld
and to require any payments required to enable it to satisfy its
withholding obligations. In the case of any Award satisfied in the
form of Shares, no Shares shall be issued unless and until
arrangements satisfactory to the Company shall have been made to
satisfy any tax withholding obligations applicable with respect to
such Award. Subject to such terms and conditions as the Committee
may impose, the Company shall have the right to retain, or the
Committee may, subject to such terms and conditions as it may
establish from time to time, permit Holders to elect to tender,
Shares (including Shares issuable in respect of an Award) to
satisfy, in whole or in part, the amount required to be
withheld.
20.7 Forfeiture
Events/Representations. The Committee may specify in an
Award Agreement at the time of the Award that the Holder’s
rights, payments and benefits with respect to an Award shall be
subject to reduction, cancellation, forfeiture or recoupment upon
the occurrence of certain specified events, in addition to any
otherwise applicable vesting or performance conditions of an Award.
Such events shall include, but shall not be limited to, termination
of service for Cause, violation of material Company policies,
breach of noncompetition, confidentiality or other restrictive
covenants that may apply to the Holder, or other conduct by the
Holder that is detrimental to the business or reputation of the
Company. The Committee may also specify in an Award Agreement that
the Holder’s rights, payments and benefits with respect to an
Award shall be conditioned upon the Holder making a representation
regarding compliance with noncompetition, confidentiality or other
restrictive covenants that may apply to the Holder and providing
that the Holder’s rights, payments and benefits with respect
to an Award shall be subject to reduction, cancellation, forfeiture
or recoupment on account of a breach of such representation.
Notwithstanding the foregoing, the confidentiality restrictions set
forth in an Award Agreement shall not, and shall not be interpreted
to, impair a Holder from exercising any legally protected
whistleblower rights (including under Rule 21 of the Exchange
Act). In addition and without limitation of the foregoing,
any amounts paid hereunder shall be subject to recoupment in
accordance with The Dodd–Frank Wall Street Reform and
Consumer Protection Act and any implementing regulations
thereunder, any “clawback” policy adopted by the
Company or as is otherwise required by applicable law or stock
exchange listing condition.
20.8 No
Restriction on Corporate Action. Nothing contained in the
Plan shall be construed to prevent the Company or any Affiliate
from taking any corporate action which is deemed by the Company or
such Affiliate to be appropriate or in its best interest, whether
or not such action would have an adverse effect on the Plan or any
Award made under the Plan. No Employee, Director, Consultant,
beneficiary or other person shall have any claim against the
Company or any Affiliate as a result of any such
action.
20.9 Restrictions
on Transfer. No Award under the Plan or any Award Agreement
and no rights or interests herein or therein, shall or may be
assigned, transferred, sold, exchanged, encumbered, pledged or
otherwise hypothecated or disposed of by a Holder except (i) by
will or by the laws of descent and distribution, or (ii) where
permitted under applicable tax rules, by gift to any Family Member
of the Holder, subject to compliance with applicable laws. An Award
may be exercisable during the lifetime of the Holder only by such
Holder or by the Holder’s guardian or legal representative
unless it has been transferred by gift to a Family Member of the
Holder, in which case it shall be exercisable solely by such
transferee. Notwithstanding any such transfer, the Holder shall
continue to be subject to the withholding requirements provided for
under Section 20.3 hereof.
-24-
20.10 Beneficiary
Designations. Each Holder may, from time to time, name a
beneficiary or beneficiaries (who may be contingent or successive
beneficiaries) for purposes of receiving any amount which is
payable in connection with an Award under the Plan upon or
subsequent to the Holder’s death. Each such beneficiary
designation shall serve to revoke all prior beneficiary
designations, be in a form prescribed by the Company and be
effective solely when filed by the Holder in writing with the
Company during the Holder’s lifetime. In the absence of any
such written beneficiary designation, for purposes of the Plan, a
Holder’s beneficiary shall be the Holder’s
estate.
20.11 Rule
16b-3. It is intended that the Plan and any Award made to a
person subject to Section 16 of the Exchange Act shall meet all of
the requirements of Rule 16b-3. If any provision of the Plan or of
any such Award would disqualify the Plan or such Award under, or
would otherwise not comply with the requirements of, Rule 16b-3,
such provision or Award shall be construed or deemed to have been
amended as necessary to conform to the requirements of Rule
16b-3.
20.12 Section
409A. Notwithstanding any other provision of the Plan, the
Committee shall have no authority to issue an Award under the Plan
with terms and/or conditions which would cause such Award to
constitute non-qualified “deferred compensation” under
Section 409A of the Code unless such Award shall be structured to
be exempt from or comply with all requirements of Code Section
409A. The Plan and all Award Agreements are intended to comply with
the requirements of Section 409A of the Code (or to be exempt
therefrom) and shall be so interpreted and construed and no amount
shall be paid or distributed from the Plan unless and until such
payment complies with all requirements of Code Section 409A. It is
the intent of the Company that the provisions of this Agreement and
all other plans and programs sponsored by the Company be
interpreted to comply in all respects with Code Section 409A,
however, the Company shall have no liability to the Holder, or any
successor or beneficiary thereof, in the event taxes, penalties or
excise taxes may ultimately be determined to be applicable to any
payment or benefit received by the Holder or any successor or
beneficiary thereof.
20.13 Indemnification.
Each person who is or shall have been a member of the Committee or
of the Board shall be indemnified and held harmless by the Company
against and from any loss, cost, liability, or expense that may be
imposed upon or reasonably incurred thereby in connection with or
resulting from any claim, action, suit, or proceeding to which such
person may be made a party or may be involved by reason of any
action taken or failure to act under the Plan and against and from
any and all amounts paid thereby in settlement thereof, with the
Company’s approval, or paid thereby in satisfaction of any
judgment in any such action, suit, or proceeding against such
person; provided,
however, that such
person shall give the Company an opportunity, at its own expense,
to handle and defend the same before he or she undertakes to handle
and defend it on his or her own behalf. The foregoing right of
indemnification shall not be exclusive and shall be independent of
any other rights of indemnification to which such persons may be
entitled under the Company’s Articles of Incorporation or
By-laws, by contract, as a matter of law, or
otherwise.
20.14 Other
Benefit Plans. No Award, payment or amount received
hereunder shall be taken into account in computing an
Employee’s salary or compensation for the purposes of
determining any benefits under any pension, retirement, life
insurance or other benefit plan of the Company or any Affiliate,
unless such other plan specifically provides for the inclusion of
such Award, payment or amount received. Nothing in the Plan shall
be construed to limit the right of the Company to establish other
plans or to pay compensation to its employees, in cash or property,
in a manner which is not expressly authorized under the
Plan.
-25-
20.15 Limits
of Liability. Any liability of the Company with respect to
an Award shall be based solely upon the contractual obligations
created under the Plan and the Award Agreement. None of the
Company, any member of the Board nor any member of the Committee
shall have any liability to any party for any action taken or not
taken, in good faith, in connection with or under the
Plan.
20.16 Foreign
Jurisdictions. The Committee may adopt, amend and terminate
such arrangements and grant such Awards, not inconsistent with the
intent of the Plan, as it may deem necessary or desirable to comply
with any tax, securities, regulatory or other laws of other
jurisdictions with respect to Awards that may be subject to such
laws. The terms and conditions of such Awards may vary from the
terms and conditions that would otherwise be required by the Plan
solely to the extent the Committee deems necessary for such
purpose. Moreover, the Board may approve such supplements to or
amendments, restatements or alternative versions of the Plan, not
inconsistent with the intent of the Plan, as it may consider
necessary or appropriate for such purposes, without thereby
affecting the terms of the Plan as in effect for any other
purpose.
20.17 Governing
Law. Except as
otherwise provided herein, the Plan shall be construed in
accordance with the laws of the State of Delaware, without regard
to principles of conflicts of law.
20.18 Severability
of Provisions. If any provision of the Plan is held invalid or
unenforceable, such invalidity or unenforceability shall not affect
any other provision of the Plan, and the Plan shall be construed
and enforced as if such invalid or unenforceable provision had not
been included in the Plan.
20.19 No
Funding. The Plan shall be unfunded. The Company shall not
be required to establish any special or separate fund or to make
any other segregation of funds or assets to ensure the payment of
any Award. Prior to receipt of Shares or a cash distribution
pursuant to the terms of an Award, such Award shall represent an
unfunded unsecured contractual obligation of the Company and the
Holder shall have no greater claim to the Shares underlying such
Award or any other assets of the Company or Affiliate than any
other unsecured general creditor.
20.20 Award
Agreements. The Committee may provide for the use of
electronic, internet or other non-paper Award Agreements, and the
use of electronic, internet or other non-paper means for the
acceptance thereof and actions thereunder by a Holder. Each Award
Agreement shall be subject to the terms and conditions of the Plan
and need not be identical.
20.21 Headings.
Headings used throughout the Plan are for convenience only and
shall not be given legal significance.
-26-
Exhibit 31.1
CERTIFICATION
PURSUANT TO RULE 13A-14 OF THE SECURITIES EXCHANGE ACT OF
1934
AS
ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF
2002
I,
James Sapirstein, Chief
Executive Officer of the Company, certify that:
|
1.
|
I
have reviewed this Quarterly Report on Form 10-Q of AzurRx
BioPharma, Inc.;
|
|
2.
|
Based on my knowledge, this report does not contain
any untrue statement of a material fact or omit to state a material
fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading
with respect to the period covered by this
report.
|
|
3.
|
Based
on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material
respects the financial condition, results of operations and cash
flows of the registrant as of, and for, the periods presented in
this report;
|
|
4.
|
The
registrant’s other certifying officer(s) and I are
responsible for establishing and maintaining disclosure controls
and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
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|
|
a.
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant,
including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in
which this report is being prepared;
|
|
|
b.
|
Designed
such internal control over financial reporting, or caused such
internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally
accepted accounting principles
|
|
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c.
|
Evaluated
the effectiveness of the registrant’s disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the
end of the period covered by this report based on such evaluation;
and
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|
|
d.
|
Disclosed
in this report any change in the registrant’s internal
control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the
registrant’s fourth fiscal quarter in the case of an annual
report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over
financial reporting; and
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5.
|
The
registrant’s other certifying officer(s) and I have
disclosed, based on our most recent evaluation of internal control
over financial reporting, to the registrant’s auditors and
the audit committee of the registrant’s board of directors
(or persons performing the equivalent functions):
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|
|
a.
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All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s
ability to record, process, summarize and report financial
information; and
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|
|
b.
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s
internal control over financial reporting.
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Date: November 16, 2020
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/s/ James
Sapirstein
James
Sapirstein
Chief
Executive Officer
(Principal
Executive Officer)
|
Exhibit 31.2
CERTIFICATION
PURSUANT TO RULE 13A-14 OF THE SECURITIES EXCHANGE ACT OF
1934
AS
ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF
2002
I,
Daniel Schneiderman, Chief
Financial Officer of the Company, certify that:
|
1.
|
I
have reviewed this Quarterly Report on Form 10-Q of AzurRx
BioPharma, Inc.;
|
|
2.
|
Based on my knowledge, this report does not contain
any untrue statement of a material fact or omit to state a material
fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading
with respect to the period covered by this
report.
|
|
3.
|
Based
on my knowledge, the financial statements, and other financial
information included in this report, fairly present in all material
respects the financial condition, results of operations and cash
flows of the registrant as of, and for, the periods presented in
this report;
|
|
4.
|
The
registrant’s other certifying officer(s) and I are
responsible for establishing and maintaining disclosure controls
and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as
defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
|
|
|
a.
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant,
including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in
which this report is being prepared;
|
|
|
b.
|
Designed
such internal control over financial reporting, or caused such
internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally
accepted accounting principles
|
|
|
c.
|
Evaluated
the effectiveness of the registrant’s disclosure controls and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the
end of the period covered by this report based on such evaluation;
and
|
|
|
d.
|
Disclosed
in this report any change in the registrant’s internal
control over financial reporting that occurred during the
registrant’s most recent fiscal quarter (the
registrant’s fourth fiscal quarter in the case of an annual
report) that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over
financial reporting; and
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5.
|
The
registrant’s other certifying officer(s) and I have
disclosed, based on our most recent evaluation of internal control
over financial reporting, to the registrant’s auditors and
the audit committee of the registrant’s board of directors
(or persons performing the equivalent functions):
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a.
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All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s
ability to record, process, summarize and report financial
information; and
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b.
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Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s
internal control over financial reporting.
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Date: November 16, 2020
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/s/ Daniel
Schneiderman
Daniel
Schneiderman
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
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Exhibit 32.1
CERTIFICATION PURSUANT
TO
18 U.S.C. SECTION
1350,
AS ADOPTED PURSUANT
TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of AzurRx
BioPharma, Inc. (the “Company”) on Form 10-Q for the period ended
September 30, 2020 as filed with the Securities and Exchange
Commission on the date hereof (the “Report”), I, James Sapirstein, Chief Executive
Officer of the Company, and Daniel
Schneiderman, Chief Financial Officer of the Company, each
certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002,
that:
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(1)
The Report fully complies with the requirements of Section 13(a) or
15(d) of the Securities Exchange Act of 1934; and
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(2)
The information contained in the Report fairly presents, in all
material respects, the financial condition and results of
operations of the Company.
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Date: November 16, 2020
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/s/
James Sapirstein
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James Sapirstein
President
and Chief Executive Officer
(Principal
Executive Officer)
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/s/
Daniel
Schneiderman
Daniel
Schneiderman
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
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