TG THERAPEUTICS, INC. - Quarter Report: 2010 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
quarterly period ended June 30, 2010
OR
¨
|
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
transition period from _______ to _______
Commission
file number 001-32639
Manhattan
Pharmaceuticals, Inc.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
(State
or other jurisdiction of
incorporation
or organization)
|
36-3898269
(I.R.S.
Employer Identification No.)
|
48 Wall
Street, New York, New York 10005
(Address
of principal executive offices)
(212)
582-3950
(Issuer’s
telephone number)
Check
whether the issuer: (1) 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 issuer 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 and posted on its corporate
Web site, if any, every Interactive Data File required to be submitted and
posted to Rule 405 of Regulation S-T during the preceding 12 months (or for such
shorter period that the registrant was required to submit and post such
files).
Yes
¨
No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of "large accelerated filer," "accelerated
filer" and "smaller reporting company" in Rule 12b-2 of the Exchange
Act.
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined by Rule
12b-2 of the Exchange Act). Yes ¨ No x
As of
August 13, 2010 there were 120,965,260 shares of the issuer’s common stock,
$.001 par value, outstanding.
INDEX
Page
|
||
PART
I
|
FINANCIAL
INFORMATION
|
|
Item
1.
|
Financial
Statements:
|
|
Unaudited
Condensed Consolidated Balance Sheets
|
4
|
|
Unaudited
Condensed Consolidated Statements of Operations
|
5
|
|
Unaudited
Condensed Consolidated Statements of Stockholders’ Equity
(Deficiency)
|
6
|
|
Unaudited
Condensed Consolidated Statements of Cash Flows
|
8
|
|
Notes
to Unaudited Condensed Consolidated Financial Statements
|
10
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
26
|
Item
3.
|
Quantitative
and Qualitative Disclosure About Market Risk
|
39
|
Item
4T.
|
Controls
and Procedures
|
39
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1.
|
Legal
Proceedings
|
40
|
Item
1A.
|
Risk
Factors
|
40
|
Item
6.
|
Exhibits
|
40
|
Signatures
|
41
|
2
Forward-Looking
Statements
This
quarterly report on Form 10-Q contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, or the
Securities Act, and Section 21E of the Securities and Exchange Act of 1934.
Any statements about our expectations, beliefs, plans, objectives, assumptions
or future events or performance are not historical facts and may be
forward-looking. These statements are often, but not always, made through the
use of words or phrases such as “anticipate,” “estimate,” “plan,” “project,”
“expect,” “may,” “intend” and similar words or phrases. Accordingly, these
statements involve estimates, assumptions and uncertainties that could cause
actual results to differ materially from those expressed in them. These
statements are therefore subject to risks and uncertainties, known and unknown,
which could cause actual results and developments to differ materially from
those expressed or implied in such statements. Such risks and uncertainties
relate to, among other factors:
|
·
|
the development of our drug
candidates;
|
|
·
|
the regulatory approval of our
drug candidates;
|
|
·
|
our use of clinical research
centers and other
contractors;
|
|
·
|
our ability to find collaborative
partners for research, development and commercialization of potential
products;
|
|
·
|
acceptance of our products by
doctors, patients or payers;
|
|
·
|
our ability to market any of our
products;
|
|
·
|
our history of operating
losses;
|
|
·
|
our ability to compete against
other companies and research
institutions;
|
|
·
|
our ability to secure adequate
protection for our intellectual
property;
|
|
·
|
our ability to attract and retain
key personnel;
|
|
·
|
availability of reimbursement for
our product candidates;
|
|
·
|
the effect of potential strategic
transactions on our
business;
|
|
·
|
our ability to obtain adequate
financing; and
|
|
·
|
the volatility of our stock
price.
|
Further,
any forward-looking statement speaks only as of the date on which it is made,
and we undertake no obligation to update any forward-looking statement or
statements to reflect events or circumstances after the date on which such
statement is made or to reflect the occurrence of unanticipated events. New
factors emerge from time to time, and it is not possible for us to predict which
factors will arise. In addition, we cannot assess the impact of each factor on
our business or the extent to which any factor, or combination of factors, may
cause actual results to differ materially from those contained in any
forward-looking statements.
3
Item
1. Unaudited Condensed Consolidated Financial Statements
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARY
(A
Development Stage Company)
Condensed
Consolidated Balance Sheets
June
30,
|
December
31,
|
|||||||
|
2010
|
2009
|
||||||
|
(unaudited)
|
(See
Note 1)
|
||||||
Assets
|
||||||||
Current assets: | ||||||||
Cash
and cash equivalents
|
$ | 1,572,031 | $ | 17,996 | ||||
Debt
issue costs, current portion
|
96,496 | 158,552 | ||||||
Other
current assets
|
157,706 | 87,177 | ||||||
Total
current assets
|
1,826,233 | 263,725 | ||||||
In-process
research and development
|
17,742,110 | - | ||||||
Property
and equipment, net
|
4,001 | 3,541 | ||||||
Debt
issue costs
|
- | 77,026 | ||||||
Other
assets
|
21,370 | 21,370 | ||||||
Total
assets
|
$ | 19,593,714 | $ | 365,662 | ||||
Liabilities
and Stockholders' Deficiency
|
||||||||
Current
Liabilities:
|
||||||||
Notes
payable, current portion, net
|
$ | 2,012,720 | $ | 1,274,062 | ||||
Accounts
payable and accrued expenses
|
373,795 | 291,175 | ||||||
Interest
payable, current portion
|
351,574 | 182,193 | ||||||
Derivative
liability
|
2,190,163 | 784,777 | ||||||
Total
current liabilities
|
4,928,252 | 2,532,207 | ||||||
Notes
payable, noncurrent portion, net
|
16,258,026 | 614,181 | ||||||
Interest
payable, noncurrent portion
|
240,377 | 55,048 | ||||||
Exchange
obligation
|
3,949,176 | 3,949,176 | ||||||
Total
liabilities
|
25,375,831 | 7,150,612 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders’
deficiency:
|
||||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares issued and
outstanding at June 30, 2010 and December 31, 2009
|
- | - | ||||||
Common
stock, $.001 par value. Authorized 500,000,000 shares; 120,965,260 shares
issued and outstanding at June 30, 2010 and 70,624,232 issued and
outstanding on December 31, 2009
|
120,966 | 70,624 | ||||||
Contingently
issuable shares
|
15,890 | - | ||||||
Additional
paid-in capital
|
55,797,295 | 55,077,861 | ||||||
Deficit
accumulated during the development stage
|
(61,716,268 | ) | (61,933,435 | ) | ||||
Total
stockholders’ deficiency
|
(5,782,117 | ) | (6,784,950 | ) | ||||
Total
liabilities and stockholders' deficiency
|
$ | 19,593,714 | $ | 365,662 |
See
accompanying notes to condensed consolidated financial
statements.
4
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Condensed
Consolidated Statements of Operations
(Unaudited)
Three months ended June 30,
|
Six months ended June 30,
|
Cumulative
period from
August 6, 2001
(inception) to
June 30,
|
||||||||||||||||||
2010
|
2009
|
2010
|
2009
|
2010
|
||||||||||||||||
Revenue
|
$ | - | $ | - | $ | - | $ | - | $ | - | ||||||||||
Costs
and expenses:
|
||||||||||||||||||||
Research
and development
|
50,999 | 6,644 | 68,766 | 51,580 | 28,400,977 | |||||||||||||||
General
and administrative
|
474,092 | 470,616 | 985,770 | 983,017 | 19,179,226 | |||||||||||||||
In-process
research and development charge
|
- | - | - | - | 11,887,807 | |||||||||||||||
Impairment
of intangible assets
|
- | - | - | - | 1,248,230 | |||||||||||||||
Loss
on disposition of intangible assets
|
- | - | - | - | 1,213,878 | |||||||||||||||
Total
operating expenses
|
525,091 | 477,260 | 1,054,536 | 1,034,597 | 61,930,118 | |||||||||||||||
Operating
loss
|
(525,091 | ) | (477,260 | ) | (1,054,536 | ) | (1,034,597 | ) | (61,930,118 | ) | ||||||||||
Other
(income) expense:
|
||||||||||||||||||||
Equity
in losses of Hedrin JV
|
- | 95,900 | - | 231,686 | 750,000 | |||||||||||||||
Change
in fair value of derivative
|
(2,808,996 | ) | 746,667 | (1,866,735 | ) | 816,667 | (1,436,665 | ) | ||||||||||||
Interest
and other income
|
(76,716 | ) | (61,900 | ) | (152,030 | ) | (188,627 | ) | (2,019,259 | ) | ||||||||||
Interest
expense
|
351,215 | 134,510 | 587,992 | 259,960 | 1,229,392 | |||||||||||||||
Loss
on early extinguishment of debt
|
159,070 | - | 159,070 | - | 159,070 | |||||||||||||||
Realized
gain on sale of marketable equity securities
|
- | - | - | - | (76,032 | ) | ||||||||||||||
Total
other (income) expense
|
(2,375,427 | ) | 915,177 | (1,271,703 | ) | 1,119,686 | (1,393,494 | ) | ||||||||||||
Net
income (loss)
|
1,850,336 | (1,392,437 | ) | 217,167 | (2,154,283 | ) | (60,536,624 | ) | ||||||||||||
Preferred
stock dividends (including imputed amounts)
|
- | - | - | - | (1,179,644 | ) | ||||||||||||||
Net
income (loss) applicable to common shares
|
$ | 1,850,336 | $ | (1,392,437 | ) | $ | 217,167 | $ | (2,154,283 | ) | $ | (61,716,268 | ) | |||||||
Net
income (loss) per common share:
|
||||||||||||||||||||
Basic
and diluted
|
$ | 0.02 | $ | (0.02 | ) | $ | 0.00 | $ | (0.03 | ) | ||||||||||
Weighted
average shares of common stock outstanding:
|
||||||||||||||||||||
Basic
and diluted
|
120,429,688 | 70,624,232 | 102,635,925 | 70,624,232 |
5
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Condensed
Consolidated Statements of Stockholders' Equity (Deficiency)
(Unaudited)
Common
stock
shares
|
Common
stock
amount
|
Additional
paid-
in
capital
|
Deficit
accumulated
during
the
development
stage
|
Other
|
Total
stockholders’
equity
(deficiency)
|
|||||||||||||||||||
Stock
issued at $0.0004 per share for subscription receivable
|
10,167,741
|
$
|
10,168
|
$
|
(6,168
|
)
|
$
|
-
|
$
|
(4,000
|
)
|
$
|
-
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
(56,796
|
)
|
-
|
(56,796
|
)
|
||||||||||||||||
Balance
at December 31, 2001
|
10,167,741
|
10,168
|
(6,168
|
)
|
(56,796
|
)
|
(4,000
|
)
|
(56,796
|
)
|
||||||||||||||
Proceeds
from subscription receivable
|
-
|
-
|
-
|
-
|
4,000
|
4,000
|
||||||||||||||||||
Stock
issued at $0.0004 per share for license rights
|
2,541,935
|
2,542
|
(1,542
|
)
|
-
|
1,000
|
||||||||||||||||||
Stock
options issued for consulting services
|
-
|
-
|
60,589
|
-
|
(60,589
|
)
|
-
|
|||||||||||||||||
Amortization
of unearned consulting services
|
-
|
-
|
-
|
-
|
22,721
|
22,721
|
||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
3,043,332
|
3,043
|
1,701,275
|
-
|
-
|
1,704,318
|
||||||||||||||||||
Net
loss
|
-
|
-
|
(1,037,320
|
)
|
(1,037,320
|
)
|
||||||||||||||||||
Balance
at December 31, 2002
|
15,753,008
|
15,753
|
1,754,154
|
(1,094,116
|
)
|
(37,868
|
)
|
637,923
|
||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
1,321,806
|
1,322
|
742,369
|
-
|
743,691
|
|||||||||||||||||||
Effect
of reverse acquisition
|
6,287,582
|
6,287
|
2,329,954
|
-
|
2,336,241
|
|||||||||||||||||||
Amortization
of unearned consulting costs
|
-
|
-
|
-
|
-
|
37,868
|
37,868
|
||||||||||||||||||
Unrealized
loss on short-term investments
|
-
|
-
|
-
|
-
|
(7,760
|
)
|
(7,760
|
)
|
||||||||||||||||
Payment
for fractional shares for stock combination
|
-
|
-
|
(300
|
)
|
-
|
(300
|
)
|
|||||||||||||||||
Preferred
stock issued at $10 per share, net of expenses
|
-
|
-
|
9,045,176
|
-
|
1,000
|
9,046,176
|
||||||||||||||||||
Imputed
preferred stock dividend
|
418,182
|
(418,182
|
)
|
-
|
||||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
(5,960,907
|
)
|
(5,960,907
|
)
|
|||||||||||||||||
Balance
at December 31, 2003
|
23,362,396
|
23,362
|
14,289,535
|
(7,473,205
|
)
|
(6,760
|
)
|
6,832,932
|
||||||||||||||||
-
|
||||||||||||||||||||||||
Exercise
of stock options
|
27,600
|
27
|
30,073
|
-
|
30,100
|
|||||||||||||||||||
Common
stock issued at $1.10, net of expenses
|
3,368,952
|
3,369
|
3,358,349
|
-
|
3,361,718
|
|||||||||||||||||||
Preferred
stock dividend accrued
|
-
|
-
|
-
|
(585,799
|
)
|
(585,799
|
)
|
|||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
-
|
-
|
281,073
|
-
|
25
|
281,098
|
||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
1,550,239
|
1,551
|
(1,380
|
)
|
-
|
(171
|
)
|
-
|
||||||||||||||||
Warrants
issued for consulting services
|
-
|
-
|
125,558
|
-
|
(120,968
|
)
|
4,590
|
|||||||||||||||||
Amortization
of unearned consulting costs
|
-
|
-
|
-
|
-
|
100,800
|
100,800
|
||||||||||||||||||
Unrealized
gain on short-term investments and reversal of unrealized loss on
short-term investments
|
-
|
-
|
-
|
-
|
20,997
|
20,997
|
||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
(5,896,031
|
)
|
-
|
(5,896,031
|
)
|
||||||||||||||||
Balance
at December 31, 2004
|
28,309,187
|
28,309
|
18,083,208
|
(13,955,035
|
)
|
(6,077
|
)
|
4,150,405
|
||||||||||||||||
Common
stock issued at $1.11 and $1.15, net of expenses
|
11,917,680
|
11,918
|
12,238,291
|
-
|
12,250,209
|
|||||||||||||||||||
Common
stock issued to vendor at $1.11 per share in satisfaction of accounts
payable
|
675,675
|
676
|
749,324
|
-
|
750,000
|
|||||||||||||||||||
Exercise
of stock options
|
32,400
|
33
|
32,367
|
-
|
32,400
|
|||||||||||||||||||
Exercise
of warrants
|
279,845
|
279
|
68,212
|
-
|
68,491
|
|||||||||||||||||||
Preferred
stock dividend accrued
|
-
|
-
|
-
|
(175,663
|
)
|
(175,663
|
)
|
|||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
-
|
-
|
477,736
|
-
|
42
|
477,778
|
||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
8,146,858
|
8,147
|
(7,251
|
)
|
-
|
(896
|
)
|
-
|
||||||||||||||||
Share-based
compensation
|
-
|
-
|
66,971
|
-
|
20,168
|
87,139
|
||||||||||||||||||
Reversal
of unrealized gain on short-term investments
|
-
|
-
|
-
|
-
|
(12,250
|
)
|
(12,250
|
)
|
||||||||||||||||
Stock
issued in connection with acquisition of Tarpan Therapeutics,
Inc.
|
10,731,052
|
10,731
|
11,042,253
|
-
|
11,052,984
|
|||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
(19,140,997
|
)
|
(19,140,997
|
)
|
|||||||||||||||||
Balance
at December 31, 2005
|
60,092,697
|
60,093
|
42,751,111
|
(33,271,695
|
)
|
987
|
9,540,496
|
|||||||||||||||||
Cashless
exercise of warrants
|
27,341
|
27
|
(27
|
)
|
-
|
-
|
||||||||||||||||||
Share-based
compensation
|
-
|
-
|
1,675,499
|
-
|
1,675,499
|
|||||||||||||||||||
Unrealized
loss on short-term investments
|
-
|
-
|
-
|
-
|
(987
|
)
|
(987
|
)
|
||||||||||||||||
Costs
associated with private placement
|
-
|
-
|
(15,257
|
)
|
-
|
(15,257
|
)
|
|||||||||||||||||
Net
loss
|
-
|
-
|
-
|
(9,695,123
|
)
|
(9,695,123
|
)
|
|||||||||||||||||
Balance
at December 31, 2006
|
60,120,038
|
60,120
|
44,411,326
|
(42,966,818)
|
-
|
1,504,628
|
6
(A
Development Stage Company)
Condensed
Consolidated Statements of Stockholders' Equity (Deficiency)
(Unaudited)
Common
stock
shares
|
Common
stock
amount
|
Additional
paid-in
capital
|
Deficit
accumulated
during
the
development
stage
|
Other
|
Total
stockholders’
equity
(deficiency)
|
|||||||||||||||||||
Common
stock issued at $0.84 and $0.90 per shares, net of
expenses
|
10,185,502
|
$
|
10,186
|
$
|
7,841,999
|
$
|
-
|
$
|
-
|
$
|
7,852,185
|
|||||||||||||
Common
stock issued to directors at $0.72 per share in satisfaction of accounts
payable
|
27,776
|
28
|
19,972
|
-
|
-
|
20,000
|
||||||||||||||||||
Common
stock issued in connection with in-licensing agreement at $0.90 per
share
|
125,000
|
125
|
112,375
|
-
|
-
|
112,500
|
||||||||||||||||||
Common
stock issued in connection with in-licensing agreement at $0.80 per
share
|
150,000
|
150
|
119,850
|
-
|
-
|
120,000
|
||||||||||||||||||
Exercise
of warrants
|
10,327
|
15
|
7,219
|
-
|
-
|
7,234
|
||||||||||||||||||
Cashless
exercise of warrants
|
5,589
|
-
|
(6
|
)
|
-
|
-
|
(6
|
)
|
||||||||||||||||
Share-based
compensation
|
-
|
-
|
1,440,956
|
-
|
-
|
1,440,956
|
||||||||||||||||||
Warrants
issued for consulting
|
-
|
-
|
83,670
|
-
|
-
|
83,670
|
||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
(12,032,252
|
)
|
(12,032,252
|
)
|
|||||||||||||||||
Balance
at December 31, 2007
|
70,624,232
|
70,624
|
54,037,361
|
(54,999,070
|
)
|
-
|
(891,085
|
)
|
||||||||||||||||
Sale
of warrant
|
-
|
-
|
150,000
|
-
|
-
|
150,000
|
||||||||||||||||||
Share-based
compensation
|
-
|
-
|
463,890
|
-
|
-
|
463,890
|
||||||||||||||||||
Warrants
issued with secured 12% notes
|
-
|
-
|
170,128
|
-
|
-
|
170,128
|
||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
(4,268,858
|
)
|
-
|
(4,268,858
|
)
|
||||||||||||||||
Balance
at December 31, 2008
|
70,624,232
|
70,624
|
54,821,379
|
(59,267,928
|
)
|
-
|
(4,375,925
|
)
|
||||||||||||||||
Cumulative
effect of a change in accounting principle
|
-
|
-
|
(150,000
|
)
|
127,778
|
-
|
(22,222
|
)
|
||||||||||||||||
Balance
at January 1, 2009, as adjusted
|
70,624,232
|
70,624
|
54,671,379
|
(59,140,150
|
)
|
-
|
(4,398,147
|
)
|
||||||||||||||||
Share-based
compensation
|
-
|
-
|
353,438
|
-
|
-
|
353,438
|
||||||||||||||||||
Warrants
issued with secured 12% notes
|
-
|
-
|
46,125
|
-
|
-
|
46,125
|
||||||||||||||||||
Warrant
issued to placement agent - secured 12% notes
|
-
|
-
|
6,919
|
-
|
-
|
6,919
|
||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
(2,793,285
|
)
|
-
|
(2,793,285
|
)
|
||||||||||||||||
Balance
at December 31, 2009
|
70,624,232
|
70,624
|
55,077,861
|
(61,933,435
|
)
|
-
|
(6,784,950
|
)
|
||||||||||||||||
Common
stock issued at $0.07, net of expenses
|
43,278,605
|
43,279
|
2,542,207
|
-
|
-
|
2,585,486
|
||||||||||||||||||
Shares
issued and issuable in Merger
|
7,062,423
|
7,063
|
1,468,984
|
-
|
15,890
|
1,491,937
|
||||||||||||||||||
Derivative
liability associated with issuance of common stock at
$0.07
|
-
|
-
|
(3,497,898
|
)
|
-
|
-
|
(3,497,898
|
)
|
||||||||||||||||
Share-based
compensation
|
-
|
-
|
206,141
|
-
|
-
|
206,141
|
||||||||||||||||||
Net
income
|
-
|
-
|
-
|
217,167
|
-
|
217,167
|
||||||||||||||||||
Balance
at June 30, 2010
|
120,965,260
|
$
|
120,966
|
$
|
55,797,295,
|
$
|
(61,716,268
|
)
|
$
|
15,890
|
$
|
(5,782,117
|
)
|
See
accompanying notes to condensed consolidated financial
statements.
7
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Condensed
Consoliated Statements of Cash Flows
(Unaudited)
Six months ended June 30,
|
Cumulative period from
August
6, 2001
(inception)
to June 30,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
income/(loss)
|
$ | 217,167 | $ | (2,154,283 | ) | $ | (60,536,624 | ) | ||||
Adjustments
to reconcile net income/(loss) to net cash used in operating
activities:
|
||||||||||||
Equity
in losses of Hedrin JV
|
- | 231,686 | 750,000 | |||||||||
Share-based
compensation
|
206,141 | 192,470 | 4,388,452 | |||||||||
Amortization
of OID and issue costs on Secured 12% Notes
|
207,612 | 248,856 | 791,585 | |||||||||
Change
in fair value of derivative
|
(1,866,735 | ) | 816,667 | (1,436,665 | ) | |||||||
Loss
on early extinguishment of debt
|
159,070 | - | 159,070 | |||||||||
Shares
issued in connection with in-licensing agreement
|
- | - | 232,500 | |||||||||
Amortization
of intangible assets
|
- | - | 145,162 | |||||||||
Depreciation
|
2,383 | 3,063 | 229,845 | |||||||||
Noncash
portion of in-process research and development charge
|
- | - | 11,721,623 | |||||||||
Loss
on impairment and disposition of intangible assets
|
- | - | 2,462,108 | |||||||||
Other
|
- | - | 31,556 | |||||||||
Changes
in operating assets and liabilities, net of acquisitions:
|
||||||||||||
Decrease
in restricted cash
|
- | 555,532 | - | |||||||||
Decrease/(increase)
in prepaid expenses and other current assets
|
50,341 | (17,591 | ) | 21,407 | ||||||||
Increase
in other assets
|
- | - | (36,370 | ) | ||||||||
Increase/(decrease)
in accounts payable and accrued expenses
|
(354,993 | ) | (458,125 | ) | 27,973 | |||||||
Increase
in interest payable, current portion
|
169,381 | 169,381 | ||||||||||
Increase
in interest payable, noncurrent portion
|
193,995 | 193,995 | ||||||||||
Net
cash used in operating activities
|
(1,015,638 | ) | (581,725 | ) | (40,685,002 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Purchase
of property and equipment
|
(2,844 | ) | - | (242,452 | ) | |||||||
Cash
acquired in connection with acquisitions
|
519,365 | - | 493,334 | |||||||||
Net
cash provided from the purchase and sale of short-term
investments
|
- | - | 435,938 | |||||||||
Proceeds
from sale of license
|
- | - | 200,001 | |||||||||
Net
cash provided by investing activities
|
516,521 | - | 886,821 | |||||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from the Hedrin JV agreement
|
- | 500,000 | 3,199,176 | |||||||||
Proceeds
from sale of notes payable
|
- | 340,270 | 1,509,915 | |||||||||
Repayments
of notes payable
|
(110,334 | ) | (70,000 | ) | (968,236 | ) | ||||||
Proceeds
related to sale of common stock, net
|
2,163,486 | - | 28,059,748 | |||||||||
Proceeds
from sale of preferred stock, net
|
- | - | 9,046,176 | |||||||||
Proceeds
from exercise of warrants and stock options and sale of warrant
|
- | - | 288,219 | |||||||||
Other,
net
|
- | - | 235,214 | |||||||||
Net
cash provided by financing activities
|
2,053,152 | 770,270 | 41,370,212 | |||||||||
Net
increase in cash and cash equivalents
|
1,554,035 | 188,545 | 1,572,031 | |||||||||
Cash
and cash equivalents at beginning of period
|
17,996 | 106,023 | - | |||||||||
Cash
and cash equivalents at end of period
|
$ | 1,572,031 | $ | 294,568 | $ | 1,572,031 |
See
accompanying notes to condensed consolidated financial
statements.
8
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Condensed
Consoliated Statements of Cash Flows
(Unaudited)
Six months ended June 30,
|
Cumulative period from
August
6, 2001
(inception)
to June 30,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Interest
paid
|
$ | 15,949 | $ | - | $ | 41,982 | ||||||
Supplemental
disclosure of noncash investing and financing activities:
|
||||||||||||
Issuance
of common stock for acquisitions
|
$ | 1,491,937 | $ | - | $ | 14,881,163 | ||||||
Conversion
of debt to common stock and warrants
|
422,000 | - | 422,000 | |||||||||
In-process research and development acquired | 17,742,110 | - | 17,742,110 | |||||||||
Investment
in Hedrin JV
|
- | 500,000 | 750,000 | |||||||||
Warrants
issued with notes payable
|
- | 53,044 | 250,562 | |||||||||
Note
issued to settle accrued expenses
|
- | - | 211,900 | |||||||||
Common
stock issued in satisfaction of accounts payable
|
- | - | 770,000 | |||||||||
Imputed
and accrued preferred stock dividend
|
- | - | 1,179,644 | |||||||||
Conversion
of preferred stock to common stock
|
- | - | 1,067 | |||||||||
Preferred
stock dividends paid by issuance of shares
|
- | - | 759,134 | |||||||||
Issuance
of common stock in connection with in-licensing agreement
|
- | - | 232,500 | |||||||||
Marketable
equity securities received in connection with sale of
license
|
- | - | 359,907 | |||||||||
Warrants
issued to consultant
|
- | - | 83,670 | |||||||||
Net
liabilities assumed over assets acquired in business
combination
|
- | - | (675,416 | ) | ||||||||
Cashless
exercise of warrants
|
- | - | 33 |
See
accompanying notes to condensed consolidated financial statements
9
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1.
|
SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
|
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of Manhattan
Pharmaceuticals, Inc. and subsidiaries (“Manhattan” or the “Company”) have
been prepared in accordance with accounting principles generally accepted in the
United States of America for interim financial information and the rules and
regulations of the Securities and Exchange Commission. Accordingly, the
unaudited condensed consolidated financial statements do not include all
information and footnotes required by accounting principles generally accepted
in the United States of America for complete annual financial statements.
In the opinion of management, the accompanying unaudited condensed consolidated
financial statements reflect all adjustments, consisting of only normal
recurring adjustments, considered necessary for a fair presentation.
Interim operating results are not necessarily indicative of results that may be
expected for the year ending December 31, 2010 or for any other interim
period. These unaudited condensed consolidated financial statements should
be read in conjunction with the Company’s audited financial statements as of and
for the year ended December 31, 2009, which are included in the Company’s
Annual Report on Form 10-K for such year. The condensed balance
sheet as of December 31, 2009 has been derived from the audited financial
statements included in the Form 10-K for that year.
As of
June 30, 2010, the Company has not generated any revenues from the development
of its products and is therefore still considered to be a development stage
company.
On March
8, 2010, the Company entered into an Agreement and Plan of Merger (the "Merger
Agreement") by and among the Company, Ariston Pharmaceuticals, Inc., a Delaware
corporation ("Ariston") and Ariston Merger Corp., a Delaware corporation and
wholly-owned subsidiary of the Company (the "Merger Sub"). Pursuant to the
terms and conditions set forth in the Merger Agreement, on March 8, 2010, the
Merger Sub merged with and into Ariston (the "Merger"), with Ariston being the
surviving corporation of the Merger. As a result of the Merger, Ariston
became a wholly-owned subsidiary of the Company. The operating results of
Ariston from March 8, 2010 to June 30, 2010 are included in the accompanying
condensed consolidated statements of operations. The condensed
consolidated balance sheets as of June 30, 2010 reflects the acquisition of
Ariston, effective March 8, 2010, the date of the Merger.
Segment
Reporting
The
Company has determined that it operates in only one segment currently, which is
biopharmaceutical research and development.
Financial
Instruments
At June
30, 2010 and December 31, 2009, the fair values of cash and cash equivalents,
accounts payable, the convertible 5% notes payable, the ICON convertible note
payable and the secured 12% notes payable approximate their carrying
values. At December 31, 2009 the fair value of the convertible 12% note
does not approximate its carrying value as a portion of the fair value is
reflected as a component of derivative liability. On April 8, 2010, the holder
of the convertible 12% note exercised its option to convert (see Note
6).
Equity in Joint
Venture
The
Company accounts for its investment in joint venture (see Note 5) using the
equity method of accounting. Under the equity method, the Company records its
pro-rata share of joint venture income or losses and adjusts the basis of its
investment accordingly.
10
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
New
Accounting Pronouncements
In
May 2009, the Financial Accounting Standards Board (“FASB”) issued a
statement which sets forth the period after the balance sheet date during which
management of a reporting entity should evaluate events or transactions that may
occur for potential recognition or disclosure in the financial statements, the
circumstances under which an entity should recognize events or transactions
occurring after the balance sheet date in its financial statements, and the
disclosures that an entity should make about events or transactions that
occurred after the balance sheet date. This statement was effective for interim
or annual periods ending after June 15, 2009, and the Company adopted the
provisions of this statement for the quarter ended June 30, 2009. The
adoption of this statement did not have a material impact on the Company’s
financial statements. In February 2010, the FASB issued new accounting
guidance that amends the previous guidance to (1) eliminate the requirement for
an SEC filer to disclose the date through which it has evaluated subsequent
events, (2) clarify the period through which conduit bond obligors must evaluate
subsequent events and (3) refine the scope of the disclosure requirements for
reissued financial statements. The Company adopted this new accounting guidance
for the quarterly period ended March 31, 2010. The adoption of this guidance did
not have a material impact on our financial statements. The Company has
evaluated all events or transactions that occurred after June 30, 2010 up
through the date we issued these financial statements, and we have disclosed all
events or transactions that have a material impact on the Company’s financial
statements.
In
August 2009, the FASB issued a new pronouncement to provide clarification
on measuring liabilities at fair value when a quoted price in an active market
is not available. In particular, this pronouncement specifies that a valuation
technique should be applied that uses either the quote of the liability when
traded as an asset, the quoted prices for similar liabilities when traded as
assets, or another valuation technique consistent with existing fair value
measurement guidance. This statement is prospectively effective for financial
statements issued for interim or annual periods ending after October 1,
2009. The adoption of this statement at December 31, 2009 did not impact the
Company’s results of operations or financial condition.
In
January 2010, the FASB issued a new pronouncement, Improving Disclosures about
Fair Value Measurements(ASU 2010-06). This provision amends previous provisions
that require reporting entities to make new disclosures about recurring and
nonrecurring fair value measurements including the amounts of and reasons for
significant transfers into and out of Level 1and Level 2 fair value measurements
and separate disclosure of purchases, sales, issuances, and settlements in the
reconciliation of Level 3 fair value measurements. This pronouncement was
effective for interim and annual reporting periods beginning after December 15,
2009, except for Level 3 reconciliation disclosures which are effective for
interim and annual periods beginning after December 15, 2010. The adoption
of this pronouncement did not have a material impact on the Company’s results of
operations or financial condition.
In April 2010, the FASB
issued a new pronouncement “Revenue Recognition – Milestone Method”. This
pronouncement provides guidance on the criteria that should be met for
determining whether the milestone method of revenue recognition is
appropriate. A vendor can recognize consideration that is contingent upon
achievement of a milestone in its entirety as revenue in the period in which the
milestone is achieved only if the milestone meets all criteria to be considered
substantive. The following criteria must be met for a milestone to be
considered substantive. The consideration earned by achieving the
milestone should 1. Be commensurate with either the level of effort
required to achieve the milestone or the enhancement of the value of the item
delivered as a result of a specific outcome resulting from the vendor’s
performance to achieve the milestone. 2, Related solely to past
performance. 3. Be reasonable relative to all deliverables and
payment terms in the arrangement. No bifurcation of an individual
milestone is allowed and there can be more than one milestone in an
arrangement. Accordingly, an arrangement may contain both substantive and
nonsubstantive milestones. This pronouncement is effective on a
prospective basis for milestones achieved in fiscal years, and interim periods
within those years, beginning on or after June 15, 2010. The adoption of
this guidance does not have a material impact on our financial
statements.
11
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Ariston
Merger
On March
8, 2010, the Company entered into the Merger Agreement by and among the Company,
Ariston and Merger Sub. Pursuant to the terms and conditions set forth in
the Merger Agreement, on March 8, 2010, the Merger Sub merged with and into
Ariston, with Ariston being the surviving corporation of the Merger. As a
result of the Merger, Ariston became a wholly-owned subsidiary of the
Company.
Under the
terms of the Merger Agreement, the consideration payable by the Company to the
stockholders and note holders of Ariston consists of the issuance of 7,062,423
shares of the Company's common stock, par value $0.001 per share, ("Common
Stock") at Closing (as defined in the Merger Agreement) plus the right to
receive up to an additional 24,718,481 shares of Common Stock (the “Milestone
Shares”) upon the achievement of certain product-related milestones described
below. In addition, the Company has reserved 38,630,723 shares of its
Common Stock for possible future issuance in connection with the conversion of
$15.45 million of outstanding Ariston convertible promissory notes. The
noteholders will not have any recourse to the Company for repayment of the notes
(their sole recourse being to Ariston), but the noteholders will have the right
to convert the notes into shares of the Company's Common Stock at the rate of
$0.40 per share. Further, the Company has reserved 5,000,000 shares of its
Common Stock for possible future issuance in connection with the conversion of
the $1.0 million outstanding Ariston convertible promissory note issued in
satisfaction of a trade payable. The noteholder will not have any recourse
to the Company for repayment of the note (their sole recourse being to Ariston),
but the noteholder will have the right to convert the note into shares of the
Company's Common Stock at the rate of $0.20 per share.
Upon the
achievement of the milestones described below, the Company would be obligated to
issue portions of the Milestone Shares to the former Ariston stockholders and
noteholders:
|
·
|
Upon the affirmative decision of
the Company’s Board of Directors, provided that such decision is made
prior to March 8, 2011, to further develop the AST-915, either internally
or through a corporate partnership, the Company would issue 8,828,029 of
the Milestone Shares.
|
|
·
|
Upon the acceptance by the FDA of
the Company's filing of the first New Drug Application for the AST-726
product candidate, the Company would issue 7,062,423 of the Milestone
Shares.
|
|
·
|
Upon the Company receiving FDA
approval to market the AST-726 product candidate in the United States of
America, the Company would issue 8,828,029 of the Milestone
Shares.
|
Certain
members and former members of the Company's board of directors and principal
stockholders of the Company owned Ariston securities. Timothy McInerney, a
director of Manhattan, owned 16,668 shares of Ariston common stock which
represented less than 1% of Ariston’s outstanding common stock as of the closing
of the Merger. Neil Herskowitz, a director of Manhattan, indirectly owned
convertible promissory notes of Ariston with interest and principal in the
amount of $192,739. Michael Weiser, a director of Manhattan, owned 117,342
shares of Ariston common stock, which represented approximately 2.1% of
Ariston’s outstanding common stock as of the closing of the Merger.
Lindsay Rosenwald, a more than 5% beneficial owner of Manhattan common stock, in
his individual capacity and indirectly through trusts and companies he controls
owned 497,911 shares of Ariston common stock, which represented approximately
8.9% of Ariston’s outstanding common stock as of the closing of the Merger and
indirectly owned convertible promissory notes of Ariston in the amount of
$141,438.
The
Company merged with Ariston principally to add new products to our portfolio.
Prior to the Merger, Ariston was a private, clinical stage specialty
biopharmaceutical company based in Shrewsbury, Massachusetts that in-licensed,
developed and planned to market novel therapeutics for the treatment of serious
disorders of the central and peripheral nervous systems.
12
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Merger date fair value of the total consideration paid was $1,491,937 which
consisted of 7,062,423 shares of the Company’s common stock issued upon the
Merger and 15,890,452 contingently issuable shares upon Ariston’s attaining
certain milestones as described above. The Company does not believe the
attainment of the milestone for AST-915 is highly probable and has recorded no
contingent consideration relative to it. The par value of the contingently
issuable common shares is reflected in the accompanying condensed consolidated
balance sheets as of June 30, 2010 as a component of stockholders’ deficiency,
contingently issuable shares.
The
following table summarizes the fair values of the assets acquired and
liabilities assumed at the Merger date:
Cash
and cash equivalents
|
$
|
519,365
|
||
Other
assets
|
120,870
|
|||
Total
identifiable assets
|
640,235
|
|||
Accounts
payable and accrued expenses
|
437,615
|
|||
ICON
convertible note payable
|
1,000,000
|
|||
5%
convertible notes payable
|
15,452,793
|
|||
Total
identifiable liabilities
|
16,890,408
|
|||
Net
identifiable assets (liabilities)
|
(16,250,173
|
)
|
||
In-process
research and development acquired
|
17,742,110
|
|||
Net
assets acquired
|
$
|
1,491,937
|
The
following supplemental pro forma information presents the financial results as
if the acquisition of Ariston had occurred on January 1, 2009 for the quarter
ended June 30, 2009 and six month period ended June 30, 2009 and on
January 1, 2010 for the quarter ended June 30, 2010 and the six month period
ended June30, 2010. This supplemental pro forma information has been
prepared for comparative purposes and does not purport to be indicative of what
would have occurred had the acquisition been made on January 1, 2009 or January
1, 2010, nor are they indicative of future results.
Pro forma consolidated results:
|
Quarter ended June 30,
|
Six
Months ended June 30,
|
||||||||||||||
2009
|
2010
|
2009
|
2010
|
|||||||||||||
Revenue
|
$ | - | $ | - | $ | - | $ | - | ||||||||
Net
loss
|
$ | (2,043,274 | ) | $ | 1,850,336 | $ | (3,597,503 | ) | $ | 63,164 | ||||||
Basic
and diluted earnings per share
|
$ | (0.03 | ) | $ | 0.01 | $ | (0.05 | ) | $ | 0.00 |
13
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
2.
|
LIQUIDITY
|
The
Company had a net income of $217,167 and negative cash flows from operating
activities of $1,015,638 for the six month period ended June 30, 2010. The net
loss applicable to common shares from date of inception, August 6, 2001, to June
30, 2010 amounts to $61,716,268.
During
the six months ended June 30, 2009 the Company received approximately
$0.3 million from the final closing of the sale of Secured 12% Notes and
approximately $0.5 million from a joint venture agreement.
During
the six months ended June 30, of 2010, the Company received $40,000
from Ariston Pharmaceuticals, Inc. in exchange for notes in January 2010 and
approximately $2.2 million from an equity financing transaction (see Note 7). In
addition approximately $422, 000 of notes payable and interest payable thereon
was converted into this equity financing transaction. The Company
repaid the $40,000 received from Ariston in the first quarter of 2010 and the
$27,000 received from Ariston in the fourth quarter of 2009 together with
interest thereon prior to the Merger.
Management
believes that the Company will continue to incur net losses through at least
June 30, 2011 and for the foreseeable future thereafter. Based on the
resources of the Company available at June 30, 2010, management believes that
the Company has sufficient capital to fund its operations through the end of
2010. Management believes that the Company will need additional equity or
debt financing or will need to generate positive cash flow from a joint venture
agreement, see Note 5, or generate revenues through licensing of its products or
entering into strategic alliances to be able to sustain its operations into
2011. Furthermore, the Company will need additional financing thereafter
to complete development and commercialization of our products. There can
be no assurances that we can successfully complete development and
commercialization of our products.
The
Company’s continued operations will depend on its ability to raise additional
funds through various potential sources such as equity and debt financing,
collaborative agreements, strategic alliances and its ability to realize the
full potential of its technology in development. Additional funds may not
become available on acceptable terms, and there can be no assurance that any
additional funding that the Company does obtain will be sufficient to meet the
Company’s needs in the long-term.
These
matters raise substantial doubt about the Company’s ability to continue as a
going concern. The accompanying financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
3.
|
COMPUTATION OF NET INCOME (LOSS)
PER COMMON SHARE
|
Basic net
income (loss) per common share is calculated by dividing net income
(loss) applicable to common shares by the weighted-average number of
common shares outstanding for the period. Diluted net income
(loss) per common share is the same as basic net income
(loss) per common share for the three and six months ended June 30,
2009, since potentially dilutive securities from stock options and stock
warrants would have an antidilutive effect because the Company incurred a net
loss during each of those periods. The amounts of potentially dilutive
securities excluded from the calculation were 213,918,782 and 99,159,628 shares
at June 30, 2010 and December 31, 2009, respectively. These amounts do not
include the 71,428,571 shares issuable upon the exercise of the put or call
rights issued in connection with the Hedrin JV (see Note 5) which were subject
to anti-dilution rights upon the issuance of common shares in the 2010 equity
financing transaction (see Note 7). At June
30, 2010, all of the dilutive securities are out of the money and are,
therefore, excluded from the computation of diluted earnings per share for the
three and six month periods ended June 30, 2010.
14
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
4.
|
SHARE-BASED
COMPENSATION
|
The
Company has stockholder-approved stock incentive plans for employees, directors,
officers and consultants. Prior to January 1, 2006, the Company accounted
for the employee, director and officer plans using the intrinsic value method.
On January 1, 2006, the Company adopted the share-based payment method for
employee options using the modified prospective transition method. Under
the modified prospective transition method, the Company recognized compensation
cost for the quarters ended June 30, 2010 and 2009 which includes a) period
compensation cost related to share-based payments granted prior to, but not yet
vested, as of January 1, 2006, based on the grant date fair value estimated in
accordance with the original provisions; and b) period compensation cost related
to share-based payments granted on or after January 1, 2006, based on the grant
date fair value estimated in accordance with the new accounting methodology. In
accordance with the modified prospective method, the Company has not restated
prior period results.
The
Company recognizes compensation expense related to stock option grants on a
straight-line basis over the vesting period. The Company
recognized share-based compensation cost of $15,259 and $88,373 for the three
month periods ended June 30, 2010 and 2009 respectively, and $206,141 and
$192,470 for the six month periods ended June 30, 2010 and 2009,
respectively. The Company did not capitalize any share-based
compensation cost.
Options
granted to consultants and other non-employees are recorded at fair value at the
date of grant and subsequently adjusted to fair value at the end of each
reporting period until such options vest, and the fair value of the
options, as adjusted, is amortized to consulting expense over the related
vesting period. Accordingly, such options are recorded at fair value
at the date of grant and subsequently adjusted to fair value at the end of
each reporting period until such options vest, and the fair value of the
options, as adjusted, is amortized to consulting expense over the related
vesting period. As a result of adjusting consultant and other
non-employee options to fair value, the Company recognized share-based
compensation (credit) / cost of $(175) and $74, respectively, for the three-and
six months ended June 30, 2009 and $392 and $770, respectively, for the
three-and six months ended June 30, 2009. The Company has allocated
share-based compensation costs to general and administrative and research and
development expenses as follows:
Three months ended June 30,
|
Six months ended June 30,
|
|||||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
General
and administrative expense:
|
||||||||||||||||
Share-based
employee compensation cost
|
$ | 15,434 | $ | 87,981 | $ | 206,067 | $ | 191,700 | ||||||||
Share-based
consultant and non-employee cost
|
(17 | ) | 39 | 7 | 77 | |||||||||||
15,417 | 88,020 | 206,074 | 191,777 | |||||||||||||
Research
and development expense:
|
||||||||||||||||
Share-based
employee compensation cost
|
- | - | - | - | ||||||||||||
Share-based
consultant and non-employee cost
|
(157 | ) | 353 | 67 | 693 | |||||||||||
(157 | ) | 353 | 67 | 693 | ||||||||||||
Total
share-based cost
|
$ | 15,260 | $ | 88,373 | $ | 206,141 | $ | 192,470 |
To
compute compensation expense in 2010 and 2009 the Company estimated the fair
value of each option award on the date of grant using the Black-Scholes model.
The Company based the expected volatility assumption on a volatility index of
peer companies as the Company did not have a sufficient number of years of
historical volatility of its common stock. The expected term of
options granted represents the period of time that options are expected to be
outstanding. The Company estimated the expected term of stock options
by the simplified method. The expected forfeiture rates are based on
the historical employee forfeiture experiences. To determine the risk-free
interest rate, the Company utilized the U.S. Treasury yield curve in effect at
the time of grant with a term consistent with the expected term of the Company’s
awards. The Company has not declared a dividend on its common stock
since its inception and has no intentions of declaring a dividend in the
foreseeable future and therefore used a dividend yield of zero.
15
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
following table shows the weighted average assumptions the Company used to
develop the fair value estimates for the determination of the compensation
charges in 2010 and 2009:
Six months ended June 30,
|
||||||||
2010
|
2009
|
|||||||
Expected
volatility
|
88 | % | 93 | % | ||||
Dividend
yield
|
- | - | ||||||
Expected
term (in years)
|
5.7 | 6 | ||||||
Risk-free
interest rate
|
2.46 | % | 2.08 | % |
The
Company has shareholder-approved incentive stock option plans for employees
under which it has granted non-qualified and incentive stock
options. In December 2003, the Company established the 2003 Stock
Option Plan (the “2003 Plan”), which provided for the granting of up to
5,400,000 options to officers, directors, employees and consultants for the
purchase of stock. In August 2005, the Company increased the number
of shares of common stock reserved for issuance under the 2003 Plan by 2,000,000
shares. In May 2007, the Company increased the number of shares of
common stock reserved for issuance under the 2003 Plan by 3,000,000
shares. In November 2009, the Company increased the number of shares
of common stock reserved for issuance under the 2003 plan by an additional
4,600,000 shares. At June 30, 2010, 15,000,000 shares were authorized
for issuance. The options have a maximum term of 10 years and vest
over a period determined by the Company’s Board of Directors (generally 3 years)
and are issued at an exercise price equal to or greater than the fair market
value of the shares at the date of grant. The 2003 Plan expires on
December 10, 2013 or when all options have been granted, whichever is sooner. At
June 30, 2010 options to purchase 11,574,936 shares were outstanding, 27,776
shares of common stock were issued and there were 4,524,528 shares
reserved for future grants under the 2003 Plan.
In July
1995, the Company established the 1995 Stock Option Plan (the”1995 Plan”), which
provided for the granting of options to purchase up to 130,000 shares of the
Company’s common stock to officers, directors, employees and
consultants. The 1995 Plan was amended several times to increase the
number of shares reserved for stock option grants. In June 2005 the
1995 Plan expired and no further options can be granted. At
June 30, 2010 options to purchase 1,127,240 shares were outstanding and no
shares were reserved for future stock option grants under the 1995
Plan.
16
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
A summary
of the status of the Company’s stock options as of June 30, 2010 and changes
during the period then ended is presented below:
Shares
|
Weighted
average
exercise
price
|
Weighted
Average
Remaining
Contractual
Term (years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Outstanding
at December 31, 2009
|
7,459,936 | $ | 0.718 | 6.160 | ||||||||||||
Granted
|
4,125,000 | $ | 0.070 | 5.700 | ||||||||||||
Exercised
|
- | |||||||||||||||
Cancelled
|
10,000 | |||||||||||||||
Outstanding
at June 30, 2010
|
11,574,936 | $ | 0.487 | 6.430 | $ | - | ||||||||||
Exercisable
at June 30, 2010
|
9,983,269 | $ | 0.554 | 5.920 | $ | - | ||||||||||
Weighted-average
fair value of options granted during the six month period ended June 30,
2010
|
$ | 0.046 |
As of
June 30, 2010, the total compensation cost related to nonvested option awards
not yet recognized is $67,763. The weighted average period over which
it is expected to be recognized is approximately 2.66 years.
5.
|
JOINT
VENTURE
|
In
February 2008, the Company and Nordic Biotech Advisors ApS through its
investment fund Nordic Biotech Venture Fund II K/S (“Nordic”) entered into a
joint venture agreement (the “Hedrin JV Agreement”) to develop and commercialize
the Company's North American rights (under license) to its Hedrin
product.
Pursuant
to the Hedrin JV Agreement, Nordic formed a new Danish limited partnership, H
Pharmaceuticals K/S, (the "Hedrin JV") and provided it with initial funding of
$2.5 million and the Company assigned and transferred its North American rights
in Hedrin to the Hedrin JV in return for a $2.0 million cash payment from the
Hedrin JV and equity in the Hedrin JV representing 50% of the nominal equity
interests in the Hedrin JV. At closing the Company recognized an
investment in the Hedrin JV of $250,000 and an exchange obligation of
$2,054,630. The exchange obligation represents the Company’s
obligation to Nordic to issue the Company’s common stock in exchange for all or
a portion of Nordic’s equity interest in the Hedrin JV upon the exercise by
Nordic of the put issued to Nordic in the Hedrin JV Agreement
transaction. The put is described below.
In June
2008, Nordic invested an additional $1.0 million, for a total of $3.5 million,
in the Hedrin JV and made an advance of $250,000 to the Hedrin JV and the Hedrin
JV made an additional $1.0 million payment, for a total of $3.0 million, to the
Company. The Hedrin JV also distributed additional ownership equity
sufficient for each of the Company and Nordic to maintain their ownership
interest at 50%. The FDA classified Hedrin as a Class III medical
device in February 2009. Upon attaining this classification of Hedrin
by the FDA, Nordic invested an additional $1.25 million, for a total investment
of $5 million, into the Hedrin JV, the Hedrin JV paid an additional
$0.5 million, for a total of $3.5 million, to the Company and the $250,000 that
Nordic advanced to the Hedrin JV in June became an equity investment in the
Hedrin JV by Nordic.
17
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In
February 2009, the Company’s exchange obligation increased by $1,000,000 and the
Company’s investment in the Hedrin JV increased by $500,000 as a result of the
investment by Nordic of an additional $1.25 million into the Hedrin JV, the
reclassification of the advance made by Nordic in June 2008 to the Hedrin JV of
$250,000 into an equity interest and the payment of $500,000 by the Hedrin JV to
the Company. At June 30, ,2010, the Company’s exchange obligation is
$3,949,176.
During
the six months ended June 30, 2010 and 2009, the Company recognized $0 and
$231,686, respectively, of equity in the losses of the Hedrin
JV. This reduced the carrying value of its investment in the Hedrin
JV to $0 at June 30, 2010 and $268,314 at June 30, 2009. As of June
30, 2010, the Company’s estimated share of the losses is $840,000; equity in
losses previously recognized was $500,000 leaving an estimated balance of
$340,000 of losses that was not recognized as of June 30, 2010.
The
Hedrin JV is responsible for the development and commercialization of Hedrin for
the North American market and all associated costs including clinical trials, if
required, regulatory costs, patent costs, and future milestone payments owed to
T&R, the licensor of Hedrin.
The
Hedrin JV has engaged the Company to provide management services to the Limited
Partnership in exchange for a management fee. For the six months
ended June 30, 2010 and 2009, the Company has recognized $150,000 and $183,845,
respectively, of other income from management fees earned from the Hedrin JV
which is included in the Company’s statements of operations for the six months
ended June 30, 2010 and 2009 as a component of interest and other
income.
As per
the Limited Partnership Agreement between the Company and Nordic (the “LPA”) in
the event that a limited partner in the Hedrin JV (a “Limited Partner”)
determines, in its reasonable good faith discretion, that the Hedrin JV requires
additional capital for the proper conduct of its business that Limited Partner
shall provide each Limited Partner with a written request for contribution of
such Limited Partner’s proportionate share, in accordance to the then respective
equity ownership in the Hedrin JV, of such requested additional capital
amount.
As per
the terms of the LPA, if a Limited Partner declines to so contribute, elects to
contribute but thereafter fails to do so timely, or elects to contribute and
timely does contribute some, but not all of, its proportionate share of the
requested additional capital amount, the other Limited Partner shall have the
option to contribute the remaining balance of such requested additional capital
amount.
As per
the terms of the LPA, the General Partner shall determine the fair market value
of the shares for purposes of determining how to allocate the number of shares
of the Hedrin JV to be issued in consideration for the contribution of
capital. If the General Partner is unable to determine the fair
market value of the shares, the fair market value for the shares shall be
determined in good faith by the contributing Limited Partner if such amount is
equal to or greater than the most recent valuation of such Hedrin JV
shares.
On
December 31, 2009, Nordic Biotech Venture Fund II (“Nordic”) delivered a written
notice to the Company for a $1,000,000 capital increase to the Hedrin
JV. In January 2010, Nordic made its capital contribution to the
Hedrin JV of $500,000. The Company did not have sufficient funds to
make such a capital contribution within the required time prescribed in the
LPA.
The
General Partner was unable to determine the fair market value of the
shares. The contributing Limited Partner, Nordic, determined in good
faith that the fair market value of the shares is equal to the most recent
valuation. The most recent valuation was the February 2009 investment
of $1,500,000 into the Hedrin JV by Nordic at $5,000 per share. As a
result of Nordic’s investing an additional $500,000 in the Hedrin JV the
ownership percentages of the Hedrin JV have changed from 50% to Nordic and 50%
for the Company to 52.38% to Nordic and 47.62% for the Company. In
the event that Nordic exercises its option to invest the remaining $500,000 of
the $1,000,000 capital increase then the ownership percentage shall change to
54.55% for Nordic and 45.45% for the Company.
18
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In April
2010 Nordic filed a Schedule 13D/A (the “ Amended 13D ”) with
the SEC. The Company is not in agreement with the Amended 13D and has written a
letter to Nordic explaining its disagreements. The Amended 13D shows
an aggregate number of shares of the Company’s common stock beneficially owned
by Nordic of 216,666,666, or 65.5%. The Company believes the correct
beneficial ownership is 85,714,286 shares, or 42.9%. The Amended
13D/A states that Nordic does not believe the Company’s determination of the
anti-dilution shares accruing to Nordic as a result of the 2010 Equity Financing
was neither reasonable nor made in good faith. As the Company has
previously stated we believe our determination was both reasonable and made in
good faith. The Amended 13D/A further states that Nordic acquired the
right to purchase an additional 5,555,556 shares of the Company’s common stock
upon exercise of the Nordic Put as a result of Nordic’s making an additional
investment in the Hedrin JV of $500,000 in January 2010. The Company
is not in agreement with this claim and there is no adjustment to Nordic’s Put
as a result of Nordic making additional capital contributions to the Hedrin
JV. In the letter to Nordic the Company also points out that Nordic’s
valuation suggestions for the warrants issued in the 2010 Equity Financing
ignore the concept of relative value inherent in the Hedrin JV
Agreement.
6.
|
NOTES
PAYABLE
|
The following is a summary of Notes
Payable at June 30, 2010:
Current
portion, net
|
Noncurrent
portion, net
|
Total
|
||||||||||
Secured
10% Notes Payable
|
$ | - | $ | - | $ | - | ||||||
Secured
12% Notes Payable
|
1,679,387 | - | 1,679,387 | |||||||||
8%
Note Payable
|
- | - | - | |||||||||
Non-interest
Bearing Note Payable
|
- | 221,900 | 221,900 | |||||||||
Convertible
12% Note Payable
|
- | - | - | |||||||||
Convertible
5% Notes Payable
|
- | 15,452,793 | 15,452,793 | |||||||||
ICON
Convertible Note Payable
|
333,333 | 583,333 | 916,666 | |||||||||
Total
|
$ | 2,012,720 | $ | 16,258,026 | $ | 18,270,746 |
a.
Secured 10% Notes
Payable
In
September 2008, Manhattan entered into a series of Secured 10% Notes (the
“Secured 10% Notes”) with certain of our directors, officers and an employee
(the “Secured 10% Note Holders”) for aggregate of
$70,000. Principal and interest on the Secured 10% Notes shall
be paid in cash on March 10, 2009 unless paid earlier by us. Pursuant
to the Secured 10% Notes, we also issued to the Secured 10% Note Holders 5-year
warrants to purchase an aggregate of 140,000 shares of our common stock at an
exercise price of $0.20 per share. Manhattan granted to the Secured
10% Note Holders a continuing security interest in certain specific refunds,
deposits and repayments due Manhattan and expected to be repaid to Manhattan in
the next several months. The Secured 10% Notes plus interest were
repaid on February 4, 2009.
b. Secured
12% Notes Payable
On
November 19, 2008, December 23, 2008 and February 3, 2009, the Company completed
the first, second and final closings on a financing transaction (the “Secured
12% Notes Transaction”). The Company sold $1,725,000 of 12% senior
secured notes (the “Secured 12% Notes”) and issued warrants to the investors to
purchase 57.5 million shares of the Company’s common stock at $0.09 per
share. The warrants expire on December 31, 2013. Net
proceeds of $1.4 million were realized from the three closings. In
addition, $78,000 of issuance costs were paid outside of the
closings. Per the terms of the 12% Notes Transaction the net
proceeds were paid into a deposit account (the “Deposit Account”) and
are to be paid out to the Company in monthly installments of $113,300
retroactive to October 1, 2008 and a one-time payment of
$200,000. Per the terms of the 12% Notes Transaction the monthly
installments are to be used exclusively to fund the current operating expenses
of the Company and the one-time payment was to be used for trade payables
incurred prior to October 1, 2008. The Company received $876,700 of
such monthly installments and the one time payment of $200,000 during the year
ended December 31, 2009. There was no remaining balance in the
Deposit Account at December 31, 2009.
19
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
National
Securities Corporation (“National”) was the placement agent for the Secured 12%
Notes Transaction. National’s compensation for acting as placement
agent is a cash fee of 10% of the gross proceeds received, a non-accountable
expense allowance of 1.5% of the gross proceeds, reimbursement of certain
expenses and a warrant to purchase such number of shares of the Company’s common
stock equal to 15% of the shares underlying the warrants issued to the
investors. The Company paid National a total of $202,000 in placement
agent fees, a non-accountable expense allowance and reimbursement of certain
expenses. In addition, the Company issued warrants to purchase 8.6
million shares of the Company’s common stock at $0.09 per
share. These warrants were valued at $29,110 and are a component of
Secured 12% notes payable issue costs. The warrants expire on
December 31, 2013.
The
Secured 12% Notes mature two years after issuance. Interest on
the Secured 12% Notes is compounded quarterly and payable at
maturity. At June 30, 2010 and December 31, 2009, accrued and unpaid
interest on the Secured 12% Notes amounted to approximately $352,000 and
$229,000, and is reflected in the accompanying balance sheets at June 30,
2010 and December 31, 2009, respectively, as part of interest
payable. The Secured 12% Notes are secured by a pledge of all of the Company’s
assets except for its investment in the Hedrin JV. In addition, to
provide additional security for the Company’s obligations under the notes, the
Company entered into a default agreement, which provides that upon an event of
default under the notes, the Company shall, at the request of the holders of the
notes, use reasonable commercial efforts to either (i) sell a part or all of the
Company’s interests in the Hedrin joint venture or (ii) transfer all or part of
the Company’s interest in the Hedrin JV to the holders of the notes, as
necessary, in order to fulfill the Company’s obligations under the notes, to the
extent required and to the extent permitted by the applicable Hedrin joint
venture agreements.
In
connection with the private placement, the Company, the placement agent and the
investors entered into a registration rights agreement. Pursuant to
the registration rights agreement, we agreed to file a registration statement to
register the resale of the shares of our common stock issuable upon exercise of
the warrants issued to the investors in the private placement, within 20 days of
the final closing date and to cause the registration statement to be declared
effective within 90 days (or 120 days upon full review by the Securities and
Exchange Commission). During the year ended December 31, 2009 we filed the
registration statement, received a comment letter from the SEC and responded to
the comment letter from the SEC. The registration statement was
declared effective on April 17, 2009.
The
Company incurred a total of approximately $424,000 of costs in the issuance of
the $1,725,000 of Secured 12% Notes sold in 2008
and 2009. These costs were capitalized and are being
amortized over the life of the Secured 12% Notes into interest
expense. During the six months ended June 30, 2010 and the year ended
December 31, 2009, the amount amortized into interest expense was approximately
$104,000 and $206,000, respectively. The remaining unamortized
balance of approximately $96,000 and $201,000 is reflected in the accompanying
balance sheets as of June 30, 2010 and December 31, 2009, respectively, as debt
issue costs.
The
Company recognized an original issue discount (the “OID”) of approximately
$194,000 on the issuance of the Secured 12% Notes sold for the value of the
warrants issued to the investors. The OID is being amortized over the
life of the Secured 12% Notes into interest expense. During the six
months ended June 30, 2010 and year ended December 31, 2009 the amount amortized
into interest expense was approximately $48,000 and $94,000,
respectively. The remaining unamortized balance of approximately
$46,000 and $93,000 has been netted against the face amount of Notes Payable in
the accompanying balance sheets as of June 30, 2010 and December 31, 2009,
respectively. As per the terms of the 12% Notes Transaction the
Company’s officers agreed to certain modifications of their employment
agreements.
20
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
c. 8%
Note Payable
On
December 21, 2009, the Company entered into a Future Advance Promissory Note
(the “8% Note”) with Ariston under which the Company may withdraw up to $67,000
bearing interest at a rate of 8%. As of December 31, 2009, the
Company had withdrawn $27,000 from Ariston subject to the terms of the 8%
Note. On January 13, 2010, the Company withdrew an additional $20,000
subject to the 8% Note and on January 28, 2010, the Company withdrew an
additional $20,000 subject to the 8% Note.
On March
4, 2010, the Company repaid Ariston the $67,000 withdrawn subject to the 8% Note
and accrued interest of $816.
d. Non-interest
Bearing Note Payable
On
October 27, 2009, the Company entered into a Settlement Agreement and Mutual
Release with Swiss Pharma Contract LTD (“Swiss Pharma”) pursuant to which the
Company agreed to pay Swiss Pharma $200,000 and issue to Swiss Pharma an
interest free promissory note in the principal amount of $250,000 in full
satisfaction of the September 5, 2008 arbitration award. The amount of the
Arbitration award was $683,027 at September 30, 2009 and was included as a
component of accrued expenses.
In
connection with the non-interest bearing note, the Company recognized an
original issue discount of $40,000 of imputed interest on the note,
which is being amortized into interest expense on a straight-line basis over the
two-year term of the note. For the six months ended June 30, 2010 and
the year ended December 31, 2009, the Company amortized $10,000 and $1,900 of
the OID into interest expense, respectively. The remaining
unamortized balance of $28,100 has been netted against the face amount of Notes
Payable in the accompanying balance sheet as of June 30, 2010.
e. Convertible
12% Note Payable
In
conjunction with the Settlement Agreement and Mutual Release with Swiss Pharma
described above, on October 28, 2009, the Company entered into a Subscription
Agreement (the “Subscription Agreement”) pursuant to which it sold a 12%
Original Issue Discount Senior Subordinated Convertible Debenture with a stated
value of $400,000 (the “Convertible 12% Note”) and a warrant to purchase
2,222,222 shares of the Company’s common stock, par value $.001 per
share for a purchase price of $200,000. The Convertible
12% Note is convertible into shares of Common Stock at an initial conversion
price of $0.09 per share, subject to adjustment, or, in the event the Company
issues new securities in connection with a financing, the Convertible 12% Note
may be converted into such new securities at a conversion price equal to the
purchase price paid by the purchasers of such new securities. The
Company may also, in its sole discretion, elect to pay interest due on the
Convertible 12% Note quarterly in shares of the Company’s common stock provided
such shares are subject to an effective registration statement. The
Convertible 12% Note is subordinated to the Company’s outstanding Secured 12%
Notes. The Warrant is exercisable at an exercise price of $0.11 per
share, subject to adjustment. Because the Convertible 12% Note and
the Warrant are convertible into shares of the Company, subject to adjustment,
the conversion feature is subject to Derivative Liability accounting (see Note
8).
National
Securities Corporation (“National”) was the placement agent for the Convertible
12% Note transaction. In connection with the issuance of the
Securities, the Company issued warrants to purchase an aggregate of 222,222
shares of Common Stock at an exercise price of $0.11 per share, subject to
adjustment, to the placement agent and certain of its
designees. Because the warrant is convertible into shares of the
Company, subject to adjustment, the warrants are subject to Derivative Liability
accounting (see Note 8). The warrants expire on October 28, 2014.
21
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
On April
8, 2010, the holder (the "Noteholder") of the outstanding Convertible12% Note,
dated October 28, 2009, with a stated value of $400,000 and $22,000 of accrued
interest, exercised its option to convert its note (including all accrued
interest thereon into 16.88 Units (as described in Note 7). The
conversion price was equal to the per Unit purchase price paid by the Investors
in the private placement. As a result of this conversion, the Company
accelerated the amortization of approximately $30,000 in issue costs and
$160,000 original issue discount, which is reflected as a loss on early
extinguishment in the accompanying statement of operations for the six months
ended June 30, 2010.
f.
Convertible 5% Notes
Payable
Upon the
Merger, Ariston issued $15,452,793 of five-year 5% notes payable (the “5% Notes
Payable”) in satisfaction of several note payable issuances. The
cumulative liability including accrued and unpaid interest of these several
issuances of notes was $15,452,793 as of the Merger date. Interest is
payable at maturity and compounds annually. The 5% Notes Payable and
accrued and unpaid interest thereon are convertible at the option of the holder
into the Company’s common stock at the conversion price of $0.40 per
share. Ariston agreed to make quarterly payments on the 5% Notes
Payable equal to 50% of the gross proceeds resulting from the revenues received
from the exploitation or commercialization of Ariston’s product candidates,
AST-726 and AST-915. The 5% Notes Payable are solely the obligation
of Ariston and have no recourse to the Company other than the conversion feature
discussed above. For the six months ended June 30, 2010, the Company
recorded approximately $240,000 in accrued interest, which is reflected as a
component of Interest Payable Noncurrent Portion in the accompanying balance
sheet as of June 30, 2010.
g.
ICON Convertible Note
Payable
Upon the
Merger, Ariston satisfied an account payable of $1,275,188 to ICON Clinical
Research Limited through the payment of $275,188 in cash and the issuance of a
three-year 5% note payable (the “ICON Note Payable”). The principal
is to be repaid in 36 monthly installments of $27,778 commencing in April
2010. Interest is payable monthly in arrears. The ICON
Convertible Note Payable is convertible at the option of the holder into the
Company’s common stock at the conversion price of $0.20 per
share. During the six months ended June 30, 2010, the Company has
paid approximately $98,000 in principal and interest to ICON. For the
six months ended June 30, 2010, the Company recorded approximately $15,000 in
interest expense as reflected on the accompanying statement of operations for
the six months ended June 30, 2010.
7.
|
2010 EQUITY
FINANCING
|
On March
2, 2010, the Company raised aggregate gross proceeds of approximately $2,547,500
pursuant to a private placement of its securities (the “2010 Equity
Financing”). The Company entered into subscription agreements (the
"Subscription Agreements") with seventy-seven accredited investors (the
"Investors") pursuant to which the Company sold an aggregate of 101.9 Units (as
defined herein) for a purchase price of $25,000 per Unit. Pursuant to
the Subscription Agreements, the Company issued to each Investor units (the
"Units") consisting of (i) 357,143 shares of common stock, $0.001 par value per
share (the “Common Stock” or “Shares”) of the Company and (ii) 535,714 warrants
(each a “Warrant” and collectively the “Warrants”), each of which will entitle
the holder to purchase one additional share of Common Stock for a period of five
years (each a “Warrant Share” and collectively the “Warrant Shares”) at an
exercise price of $0.08 per share. Because the Warrant Shares are
convertible into shares of the Company, subject to adjustment, the conversion
feature is subject to Derivative Liability accounting (see Note 8).
National
was the placement agent for the 2010 Equity Financing transaction. In
connection with the issuance of the Securities, the Company issued warrants to
purchase an aggregate of 3,369,289 shares of Common Stock at an exercise price
of $0.08 per share, subject to adjustment, to the placement agent and certain of
its designees. Because the warrant is convertible into shares of the
Company, subject to adjustment, the warrants are subject to Derivative Liability
accounting (see Note 8). The warrants expire on March 2, 2015.
22
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Nordic Put and Nordic Warrant were issued at a value of $0.14 per share and were
issued with anti-dilution rights. The issuance of any securities at a value of
less than $0.14 per share activates Nordic’s anti-dilution rights. The Secured
12% Note transaction included warrants with an exercise price of $0.09 per
share, this activated Nordic’s anti-dilution rights as reflected in the table
below under the caption “Before the Equity Pipe Transaction”. Any
issuances of any securities subsequent to the Secured 12% Note transaction at a
value of less than $0.09 further activates Nordic’s anti-dilution
rights. The Equity Pipe transaction in March 2010 effectively
included the sale of one share of common stock and a warrant to purchase 1.5
shares of common stock for a price of $0.07. The JV Agreement between Nordic and
Manhattan governs the antidilution protection to Nordic. Section 5.1
of that agreement state “If shares of Common Stock or Common Stock Equivalents
are issued or sold together with other stock or securities or other assets of
MHA (Manhattan) for a consideration which covers both, the effective price per
share shall be computed with regard to the portion of the consideration so
received that may reasonably be determined in good faith by the Board of
Directors, to be allocable to such Common Stock or Common Stock
Equivalent.” The good faith determination of the effective price per
share was $0.07 for each share of common stock sold and a de minimus value to
the warrants. The Nordic Put and the Nordic Warrant are now valued at
a price of $0.07 per share. The following table shows the effect of
Nordic’s anti-dilution rights.
Shares
Issuable
Upon Exercise
of
Nordic's Put
|
Shares
Issuable
Upon Exercise
of
Nordic's
Warrant
|
Total Shares
Issuable
Upon Exercise
of
Nordic's Put
and
Warrant
|
||||||||||
Before
the Equity Pipe Transaction
|
55,555,556
|
11,111,111
|
66,666,667
|
|||||||||
Antidilution
shares
|
15,873,015
|
3,174,603
|
19,047,618
|
|||||||||
After
the Equity Pipe Transaction
|
71,428,571
|
14,285,714
|
85,714,285
|
In March
2010, we received correspondence from Nordic that questions how we calculated
the anti-dilution shares, as shown above, and suggesting that we did not employ
a good faith estimate. We believe our determination was made in good
faith and is appropriate. See Note 5.
All of
the Investors represented that they were “accredited investors,” as that term is
defined in Rule 501(a) of Regulation D under the Securities Act, and the sale of
the Units was made in reliance on exemptions provided by Regulation D and
Section 4(2) of the Securities Act of 1933, as amended.
In
connection with the closing of the private placement, the Company, the placement
agent acting in connection with the private placement (the “Placement Agent”)
and the Investors entered into a Registration Rights Agreement, dated as of
March 2, 2010, and the Company agreed to file a registration statement to
register the resale of the Shares, within 60 days of the final closing date and
to cause the registration statement to be declared effective within 150 days (or
180 days upon review by the SEC).
The
Company received net proceeds of approximately $2,100,000 after payment of an
aggregate of approximately $300,000 of commissions and expense allowance to the
Placement Agent, and approximately $100,000 of other offering and related costs
in connection with the private placement. In addition, the Company issued a
warrant to purchase 3,639,289 shares of Common Stock at an exercise price of
$0.08 per share to the Placement Agent as additional compensation for its
services.
The
Company did not use any form of advertising or general solicitation in
connection with the sale of the Units. The Shares, the Warrants and the Warrant
Shares are non-transferable in the absence of an effective registration
statement under the Act, or an available exemption therefrom, and all
certificates are imprinted with a restrictive legend to that
effect.
23
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
On April
8, 2010, the Company completed the final closing of the 2010 Equity
Financing. In connection with the final closing, the Company sold an
aggregate of 2.4 additional Units and received net proceeds of approximately
$51,700 after payment of an aggregate of $8,300 of commissions and expense
allowance to placement agent. In connection with the final closing, the Company
also issued a warrant to purchase 12,857 shares of Common Stock at an exercise
price of $0.08 per share to the placement agent as additional compensation for
its services.
In
addition on April 8, 2010, the holder of the Convertible 12% Note (see Note 6)
with a stated value of $400,000 and $22,000 of accrued interest, exercised its
option to convert its Debenture (including all accrued interest thereon) into
16.88 Units. The conversion price was equal to the per Unit purchase
price paid by the Investors in the private placement.
The
Company issued a total of 6,885,717 shares of common stock and warrants to
purchase 10,328,566 shares of common stock at an exercise price of $0.08 per
share to the investors in the final closing of the 2010 Equity Financing,
including the conversion of the 12% Convertible Note.
8.
|
DERIVATIVE
LIABILITY
|
In April
2008, the FASB issued a pronouncement which provides guidance on determining
what types of instruments or embedded features in an instrument held by a
reporting entity can be considered indexed to its own stock for the purpose of
evaluating the first criteria of the scope exception in the pronouncement on
accounting for derivatives. This pronouncement was effective for financial
statements issued for fiscal years beginning after December 15, 2008. The
adoption of these requirements can affect the accounting for warrants and many
convertible instruments with provisions that protect holders from a decline in
the stock price (or “down-round” provisions). For example, warrants with such
provisions will no longer be recorded in equity. Down-round provisions reduce
the exercise price of a warrant or convertible instrument if a company either
issues equity shares for a price that is lower than the exercise price of those
instruments or issues new warrants or convertible instruments that have a lower
exercise price. We evaluated whether warrants to acquire stock of the Company
contain provisions that protect holders from declines in the stock price or
otherwise could result in modification of the exercise price under the
respective warrant agreements. We determined that the warrant issued to Nordic
in April 2008 (the “Nordic Warrant”), the warrants issued in connection with the
2009 sale of the Convertible 12% Note Payable and its subsequent conversion in
April 2010, and the warrants issued in connection with the 2010 Equity Financing
contained such provisions, thereby concluding they were not indexed to the
Company’s own stock and were reclassified from equity to derivative
liabilities.
In
accordance with this pronouncement, the Company estimated the fair value of the
Nordic Warrant as of January 1, 2009 to be $22,222 by recording a
reduction in additional paid-in capital of $150,000 and a decrease in deficit
accumulated during the development stage of $127,778. The effect of this
adjustment is recorded as a cumulative effect of change in accounting principle
in our statements of stockholders’ equity (deficiency). As of June
30, 2010, the fair value of these derivatives was $350,000 as recorded in the
accompanying balance sheet as of June 30, 2010, as a component of a current
liability, derivative liability. The change of $(465,714) and $(133,333) in fair
value during the three and six months ended June 30, 2010, respectively, is
reported as a noncash charge in the accompanying consolidated statements of
operations as a component of other (income) expense.
In
accordance with this pronouncement the Company estimated the fair value at the
date of issuance of the conversion feature of the Convertible 12% Note and the
fair value of the related warrants to purchase 2,444,444 shares of the Company’s
common stock at $175,100 and $27,390, respectively. On April 8, 2010,
the holder of the Convertible 12% Note exercised his option to
convert. As a result, the derivative liability associated with the
notes were reclassified to Convertible 12% Note Payable with the change in fair
value from the date of issuance $29,506 reclassified as a loss on early
extinguishment of debt in the accompanying statement of operations for the six
months ended June 30, 2010. As of June 30, 2010 the fair value of
these derivatives related to the warrants outstanding totaled $67,956 and are
recorded in the accompanying balance sheet as of June 30, 2010 as a component of
derivative liability. The change in fair value of $(81,889) and
$(53,044) during the three and six months ended June 30, 2010, respectively, is
reported as a non-cash charge in the accompanying consolidated statements of
operations as a component of other (income) expense.
24
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(a
Development Stage Company)
NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
In
addition, in accordance with this pronouncement, the Company estimated the fair
value at the date of issuance of the 9,042,853 warrants issued in
connection with the conversion of the Convertible 12% Note at
$528,103. As of June 30, 2010, the fair value of these derivatives
was $236,018 as recorded in the accompanying balance sheet as of June 30, 2010,
as a component of a current liability, derivative liability. The
change of $(292,084) in fair value during the quarter ended June 30, 2010 is
reported as a non-cash charge in the accompanying consolidated statements of
operations as a component of other (income) expense.
Additionally,
in accordance with this pronouncement the Company estimated the fair value at
the date of issuance of the 54,589,266 warrants issued in connection with the
2010 Equity Financing and the fair value of the related 3,369,289 warrants
issued to the placement agents in the 2010 Equity Financing at
$2,713,087 and $180,873, respectively. As of June 30, 2010
the fair value of these derivatives totaled $1,502,297 and are recorded in the
accompanying consolidated balance sheet as of June 30, 2010 as a component of
derivative liability. The change in fair value of $(1,927,365) during
the quarter ended June 30, 2010 is reported as a non-cash charge in the
consolidated statements of operations as a component of other (income)
expense.
Additionally,
in accordance with this pronouncement the Company estimated the fair value at
the date of issuance of the 1,285,714 warrants issued in connection with the
final closing of the 2010 Equity Financing in April 2010 and the fair value of
the related 12,857 warrants issued to the placement agents in the final closing
of the 2010 Equity Financing at $75,086 and $751,
respectively. As of June 30, 2010 the fair value of these derivatives
totaled $33,893 and are recorded in the accompanying consolidated balance sheet
as of June 30, 2010 as a component of derivative liability. The
change in fair value of $(41,944) during the quarter ended June 30, 2010 is
reported as a non-cash charge in the accompanying consolidated statement of
operations as a component of other (income) expense.
9.
|
SUBSEQUENT
EVENT
|
In July
2010, Nordic delivered a written notice to the Company for a $500,000 capital
increase to the Hedrin JV and made a $500,000 capital
contribution. The Company does not regard either the notice or the
capital contribution as being properly made as per the agreements between Nordic
and the Company. No valuation has been set for this capital
contribution. The Company reserved its right to make its pro rata
share of the capital contribution, but has not yet determined whether to make
the capital contribution or not. Nordic may dispute the Company’s
right to make its pro rata share of the capital
contribution.
25
Item
2. Management’s Discussion and Analysis of Financial Condition and
Results of Operations.
You
should read the following discussion of our results of operations and financial
condition in conjunction with our Annual Report on Form 10-K for the year ended
December 31, 2009 (the “Annual Report”) and our financial statements for the six
month period ended June 30, 2010 included elsewhere in this report.
We were
incorporated in Delaware in 1993 under the name “Atlantic Pharmaceuticals, Inc.”
and, in March 2000, we changed our name to “Atlantic Technology Ventures,
Inc.” In 2003, we completed a “reverse acquisition” of privately held
“Manhattan Research Development, Inc”. In connection with this
transaction, we also changed our name to “Manhattan Pharmaceuticals,
Inc.” From an accounting perspective, the accounting acquirer is
considered to be Manhattan Research Development, Inc. and accordingly, the
historical financial statements are those of Manhattan Research Development,
Inc.
During
2005 we merged with Tarpan Therapeutics, Inc. (“Tarpan”). Tarpan was
a privately held New York based biopharmaceutical company developing
dermatological therapeutics. This transaction was
accounted for as a purchase of Tarpan by the Company.
On March
8, 2010, the Company entered into an Agreement and Plan of Merger (the "Merger
Agreement") by and among the Company, Ariston Pharmaceuticals, Inc., a Delaware
corporation ("Ariston") and Ariston Merger Corp., a Delaware corporation and
wholly-owned subsidiary of the Company (the "Merger Sub"). Pursuant
to the terms and conditions set forth in the Merger Agreement, on March 8, 2010,
the Merger Sub merged with and into Ariston (the "Merger"), with Ariston being
the surviving corporation of the Merger. As a result of the Merger,
Ariston became a wholly-owned subsidiary of the Company. The
operating results of Ariston from March 8, 2010 to June 30, 2010 are included in
the accompanying Condensed Consolidated Statements of Operations. The
Condensed Consolidated Balance Sheet as of June 30, 2010 reflects the
acquisition of Ariston, effective March 8, 2010, the date of the
Merger.
We are a
specialty healthcare product company focused on developing and
commercializing pharmaceutical treatments for underserved patient
populations. We aim to acquire rights to these technologies by
licensing or otherwise acquiring an ownership interest, funding their research
and development and eventually either bringing the technologies to market or
out-licensing.
This
discussion includes “forward-looking” statements that reflect our current views
with respect to future events and financial performance. We use words
such as we “expect,” “anticipate,” “believe,” and “intend” and similar
expressions to identify forward-looking statements. Investors should
be aware that actual results may differ materially from our expressed
expectations because of risks and uncertainties inherent in future events,
particularly those risks identified under the heading “Risk Factors” following
Item 1 in the Annual Report, and should not unduly rely on these forward looking
statements.
26
Results
of Operations
Six-month
Periods ended June 30, 2010 vs 2009:
Six Months ended June 30,
|
Increase/
|
% Increase/
|
||||||||||||||
2010
|
2009
|
(decrease)
|
(decrease)
|
|||||||||||||
Costs
and expenses:
|
||||||||||||||||
Research
and development:
|
||||||||||||||||
Share-based
compensation
|
$ | - | $ | 1,000 | $ | (1,000 | ) | -100.00 | % | |||||||
Other
research and development expenses
|
69,000 | 51,000 | 18,000 | 35.29 | % | |||||||||||
Total
research and development expenses
|
69,000 | 52,000 | 17,000 | 32.69 | % | |||||||||||
General
and administrative:
|
||||||||||||||||
Share-based
compensation
|
206,000 | 192,000 | 14,000 | 7.29 | % | |||||||||||
Other
general and administrative expenses
|
780,000 | 791,000 | (11,000 | ) | -1.39 | % | ||||||||||
Total
general and administrative expenses
|
986,000 | 983,000 | 3,000 | 0.31 | % | |||||||||||
Other
income/(expense):
|
||||||||||||||||
Equity
in losses of Hedrin JV
|
- | (232,000 | ) | 232,000 | -100.00 | % | ||||||||||
Change
in fair value of derivative
|
1,867,000 | (817,000 | ) | 2,684,000 | -328.52 | % | ||||||||||
Loss
on early extinguishment of debt
|
(159,000 | ) | - | (159,000 | ) | N/A | ||||||||||
Interest
expense
|
(588,000 | ) | (259,000 | ) | (329,000 | ) | 127.03 | % | ||||||||
Interest
and other income
|
152,000 | 189,000 | (37,000 | ) | -19.58 | % | ||||||||||
Total
other income/(expense)
|
1,272,000 | (1,119,000 | ) | 2,391,000 | -213.67 | % | ||||||||||
Net
income/(loss)
|
$ | 217,000 | $ | (2,154,000 | ) | $ | 2,371,000 | -110.07 | % |
During
each of the six month periods ended June 30, 2010 and 2009, we did not recognize
any revenues. We are considered a development stage company and do
not expect to have revenues relating to our products candidates prior to June
30, 2011, if at all.
For the
six months ended June 30, 2010 research and development expense was $69,000 as
compared to $52,000 for the six months ended June 30, 2009. This
increase of $17,000, or 33%, is primarily due to commencement of development
activity on our AST-726 project during the 2010 period and limited product
development activity during the 2009 period.
For the
six months ended June 30, 2010 general and administrative expense was
$986,000 as compared to $983,000 for the six months ended June30,
2009. This increase of $3,000 is less than 1%.
For the
six months ended June 30, 2010 other income/(expense) was $1,272,000 as compared
to $(1,119,000) for the six months ended June 30, 2009. This change
of $2,391,000, or (214)%, is primarily due to a change in fair value of a
derivative of $2,684,000 and a decrease in equity in losses of Hedrin JV of
$232,000, offset by an increase in interest expense of $329,000, an increase of
$159,000 in loss on early extinguishment of debt and a decrease in other income
of $37,000.
Net
income for the six months ended June 30, 2010 was $217,000 as compared to a net
loss of $2,154,000 for the six months ended June 30, 2009. This
change of $2,371,000, or 110%, is primarily due to a change in fair value of a
derivative of $2,684,000.
27
Three-month
Periods ended June 30, 2010 vs 2009:
Three Months ended June 30,
|
Increase/
|
% Increase/
|
||||||||||||||
2010
|
2009
|
(decrease)
|
(decrease)
|
|||||||||||||
Costs
and expenses:
|
||||||||||||||||
Research
and development:
|
||||||||||||||||
Share-based
compensation
|
$ | - | $ | - | $ | - | N/A | |||||||||
Other
research and development expenses
|
51,000 | 7,000 | 44,000 | 628.57 | % | |||||||||||
Total
research and development expenses
|
51,000 | 7,000 | 44,000 | 628.57 | % | |||||||||||
General
and administrative:
|
||||||||||||||||
Share-based
compensation
|
15,000 | 88,000 | (73,000 | ) | -82.95 | % | ||||||||||
Other
general and administrative expenses
|
460,000 | 382,000 | 78,000 | 20.42 | % | |||||||||||
Total
general and administrative expenses
|
475,000 | 470,000 | 5,000 | 1.06 | % | |||||||||||
Other
income/(expense):
|
||||||||||||||||
Equity
in losses of Hedrin JV
|
- | (96,000 | ) | 96,000 | -100.00 | % | ||||||||||
Change
in fair value of derivative
|
2,809,000 | (747,000 | ) | 3,556,000 | -476.04 | % | ||||||||||
Loss
on early extinguishment of debt
|
(159,000 | ) | - | (159,000 | ) | N/A | ||||||||||
Interest
expense
|
(351,000 | ) | (134,000 | ) | (217,000 | ) | 161.94 | % | ||||||||
Interest
and other income
|
77,000 | 62,000 | 15,000 | 24.19 | % | |||||||||||
Total
other income/(expense)
|
2,376,000 | (915,000 | ) | 3,291,000 | -359.67 | % | ||||||||||
Net
income/(loss)
|
$ | 1,850,000 | $ | (1,392,000 | ) | $ | 3,242,000 | -232.90 | % |
For the
three months ended June 30, 2010 research and development expense was $51,000 as
compared to $7,000 for the three months ended June 30, 2009. This
increase of $44,000, or 629%, is primarily due to commencement of development
activity on our AST-726 project during the 2010 period and limited product
development activity during the 2009 period.
For the
three months ended June 30, 2010 general and administrative expense was $475,000
as compared to $470,000 for the three months ended June30, 2009. This
increase of $5,000 is approximately 1%.
For the
three months ended June 30, 2010 other income/(expense) was $2,376,000 as
compared to $(915,000) for the three months ended June 30, 2009. This
change of $3,291,000, or (360)%, is primarily due to a change in fair value of a
derivative of $3,556,000, a decrease in equity in losses of Hedrin JV of $96,000
and a increase in other income of $15,000 offset by an increase in interest
expense of $217,000 and an increase of $159,000 in loss on early extinguishment
of debt.
Net
income for the three months ended June 30, 2010 was $1,850,000 as compared to a
net loss of $1,392,000 for the three months ended June 30, 2009. This
change of $3,242,000, or 233%, is primarily due to a change in fair value of a
derivative of $3,556,000, which resulted from a decrease in the market price of
our stock.
Liquidity
and Capital Resources
From
inception to June 30, 2010, we incurred a deficit during the development stage
of $61,716,000 primarily as a result of our net losses, and we expect to
continue to incur additional losses through at least June 30, 2011 and for the
foreseeable future. These losses have been incurred through a
combination of research and development activities related to the various
technologies under our control and expenses supporting those
activities.
We have
financed our operations since inception primarily through equity and debt
financings and a joint venture transaction. During the six
months ended June 30, 2010, we had a net increase in cash and cash
equivalents of $1.6 million. This increase resulted largely from net
cash provided by financing activities of $2.2 million and $0.5 million of cash
acquired in the Ariston merger partially offset by net cash used in operating
activities of $1.1 million. Total liquid resources as of June 30,
2010 were $1.6 million compared to $18,000 at December 31,
2009.
28
Our
current liabilities as of June 30, 2010 were $4,928,000 compared to $2,532,000
at December 31, 2009, an increase of $2,396,000. As of June 30, 2010,
we had working capital deficit of $3,102,000 compared to working capital deficit
of $2,268,000 at December 31, 2009.
The
Company received net proceeds of approximately $2,200,000 in March and April
2010 from the 2010 Equity Financing. In addition $400,000 principal
amount of debt converted into the 2010 Equity Financing. The Company
also acquired $519,000 of cash in the merger with Ariston.
Our
available working capital and capital requirements will depend upon numerous
factors, including progress of our research and development programs, our
progress in and the cost of ongoing and planned nonclinical and clinical
testing, the timing and cost of obtaining regulatory approvals, the cost of
filing, prosecuting, defending, and enforcing patent claims and other
intellectual property rights, in-licensing activities, competing technological
and market developments, changes in our existing collaborative and licensing
relationships, the resources that we devote to developing manufacturing and
commercializing capabilities, the status of our competitors, our ability to
establish collaborative arrangements with other organizations and our need to
purchase additional capital equipment.
Our
continued operations will depend on whether we are able to raise additional
funds through various potential sources, such as equity and debt financing,
other collaborative agreements, strategic alliances, and our ability to realize
the full potential of our technology in development. Such additional
funds may not become available on acceptable terms and there can be no assurance
that any additional funding that we do obtain will be sufficient to meet our
needs in the long term. Through June 30, 2010, a significant portion
of our financing has been through private placements of common stock and
warrants. Unless our operations generate significant revenues and
cash flows from operating activities, we will continue to fund operations from
cash on hand and through the similar sources of capital previously
described. We can give no assurances that any additional capital that
we are able to obtain will be sufficient to meet our needs. We
believe that we will continue to incur net losses and negative cash flows from
operating activities for the foreseeable future.
Based on
the resources of the Company available at June 30, 2010, management believes
that the Company has sufficient capital to fund its operations through
2010. Management believes that the Company will need additional
equity or debt financing or will need to generate positive cash flow from the
Hedrin JV, or generate revenues through licensing of its products or entering
into strategic alliances to be able to sustain its operations into
2011. Furthermore, the Company will need additional financing
thereafter to complete development and commercialization of its
products. There can be no assurances that we can successfully
complete development and commercialization of our products.
These
matters raise substantial doubt about the Company’s ability to continue as a
going concern. The accompanying financial statements do not include
any adjustments that might result from the outcome of this
uncertainty.
We have
reported net income of $217,000 for the six month periods ended June
30, 2010 and a net loss of $2,154,000 for the six month periods ended June 30,
2009. The net loss attributable to common shares from date of
inception, including preferred stock dividends, August 6, 2001 to June 30, 2010,
amounts to $61,716,000. Management believes that we will continue to
incur net losses through at least June 30, 2011.
29
Joint
Venture Agreement
We and
Nordic Biotech Venture Fund II K/S, or Nordic, entered into a joint venture
agreement on January 31, 2008, which was amended on February 18, 2008 and on
June 9, 2008. Pursuant to the joint venture agreement, in February
2008, (i) Nordic contributed cash in the amount of $2.5 million to H
Pharmaceuticals K/S (formerly Hedrin Pharmaceuticals K/S), a newly formed Danish
limited partnership, or the Hedrin JV, in exchange for 50% of the equity
interests in the Hedrin JV, and (ii) we contributed certain assets to North
American rights (under license) to our Hedrin product to the Hedrin JV in
exchange for $2.0 million in cash and 50% of the equity interests in the Hedrin
JV. On or around June 30, 2008, in accordance with the terms of the
joint venture agreement, Nordic contributed an additional $1.25 million in cash
to the Hedrin JV, $1.0 million of which was distributed to us and equity in the
Hedrin JV was distributed to each of us and Nordic sufficient to maintain our
respective ownership interests at 50%.
Pursuant
to the joint venture agreement, upon the classification by the U.S. Food and
Drug Administration, or the FDA, of Hedrin as a Class II or Class III medical
device, Nordic was required to contribute to the Hedrin JV an additional $1.25
million in cash, $0.5 million of which was to be distributed to us and equity in
the Hedrin JV was to be distributed to each of us and Nordic sufficient to
maintain our respective ownership interests at 50%. The
FDA notified the Hedrin JV that Hedrin has been classified as a Class III
medical device and in February 2009, Nordic made the $1.25 million investment in
the Hedrin JV, the Hedrin JV made the $0.5 million milestone payment to us and
equity in the Hedrin JV was distributed to us and Nordic sufficient to maintain
our respective ownership interests at 50%.
The
Hedrin JV is responsible for the development and commercialization of Hedrin for
the North American market and all associated costs including clinical trials, if
required, regulatory costs, patent costs, and future milestone payments owed to
Thornton & Ross Ltd., or T&R, the licensor of Hedrin. The
Hedrin JV has engaged us to provide management services to the Hedrin JV in
exchange for an annualized management fee, which for the six month periods ended
June 30, 2010 and 2009 was approximately $150,000 and $184,000,
respectively.
The
profits of the Hedrin JV will be shared by us and Nordic in accordance with our
respective equity interests in the Hedrin JV, of which we each currently hold
47.62%, except that Nordic is entitled to receive a minimum return each year
from the Hedrin JV equal to 6% on Hedrin sales, as adjusted for any change in
Nordic’s equity interest in the Hedrin JV, before any distribution is made to
us. If the Hedrin JV realizes a profit in excess of the Nordic
minimum return in any year, then such excess shall first be distributed to us
until our distribution and the Nordic minimum return are in the same ratio as
our respective equity interests in the Hedrin JV and then the remainder, if any,
is distributed to Nordic and us in the same ratio as our respective equity
interests. However, in the event of a liquidation of the Hedrin JV,
Nordic’s distribution in liquidation must equal the amount Nordic invested in
the Hedrin JV ($5.5 million) plus 10% per year, less the cumulative
distributions received by Nordic from the Hedrin JV before any distribution is
made to us. If the Hedrin JV’s assets in liquidation exceed the
Nordic liquidation preference amount, then any excess shall first be distributed
to us until our distribution and the Nordic liquidation preference amount are in
the same ratio as our respective equity interests in the Hedrin JV and then the
remainder, if any, is distributed to Nordic and us in the same ratio as our
respective equity interests. Further, in no event shall Nordic’s
distribution in liquidation be greater than assets available for distribution in
liquidation.
Pursuant
to the terms of the joint venture agreement, Nordic has the right to nominate
one person for election or appointment to our board of directors. The
Hedrin JV's board of directors consists of four members, two members appointed
by us and two members appointed by Nordic. Nordic has the right to
appoint one of the directors as chairman of the board. The chairman
has certain tie breaking powers.
Pursuant
to the joint venture agreement, Nordic has the right to put all or a portion of
the interest Nordic received in exchange for the first $5 million Nordic
invested in the Hedrin JV in exchange for such number of shares of our common
stock equal to the amount of Nordic’s investment in the Hedrin JV divided by
$0.07, as adjusted for the 2010 Equity Financing, and as further adjusted from
time to time for stock splits and other specified events, multiplied by a
conversion factor, which is (i) 1.00 for so long as Nordic's distributions from
the Hedrin JV are less than the amount of its investment, (ii) 1.25 for so long
as Nordic's distributions from the Hedrin JV are less than two times the amount
of its investment but greater than or equal to the amount of its investment
amount, (iii) 1.50 for so long as Nordic's distributions from the Hedrin JV are
less than three times the amount of its investment but greater than or equal to
two times the amount of its investment amount, (iv) 2.00 for so long as Nordic's
distributions from the Hedrin JV are less than four times the amount of its
investment but greater than or equal to three times the amount of its investment
amount and (v) 3.00 for so long as Nordic’s distributions from Hedrin JV are
greater than or equal to four times the amount of its investment. The
put right expires upon the earlier to occur of (i) February 25, 2018 and (ii) 30
days after the date when Nordic's distributions from the Hedrin JV exceed five
times the amount Nordic has invested in the Hedrin JV (or 10 days after such
date if we have provided Nordic notice thereof).
30
Pursuant
to the joint venture agreement, we have the right to call all or a portion of
Nordic's equity interest in the Hedrin JV in exchange for such number of shares
of our common stock equal to the portion of Nordic's investment in the Hedrin JV
that we call by the dollar amount of Nordic's investment as of such date in the
Hedrin JV, divided by $0.07, as adjusted for the sale of the Secured
12% Notes in the fourth quarter of 2008, and as further adjusted from time to
time for stock splits and other specified events. The call right is
only exercisable by us if the price of our common stock has closed at or above
$1.40 per share for 30 consecutive trading days. During the first 30
consecutive trading days in which our common stock closes at or above $1.40 per
share, we may exercise up to 25% of the call right. During the second
30 consecutive trading days in which our common stock closes at or above $1.40
per share, we may exercise up to 50% of the call right on a cumulative
basis. During the third consecutive 30 trading days in which our
common stock closes at or above $1.40 per share, we may exercise up to 75% of
the call right on a cumulative basis. During the fourth consecutive
30 days in which our common stock closes at or above $1.40 per share, we may
exercise up to 100% of the call right on a cumulative basis. Nordic
may refuse the call, either by paying $1.5 million multiplied by the percentage
of Nordic's investment being called or forfeiting an equivalent portion of the
put right, calculated on a pro rata basis for the percentage of the Nordic
equity interest called by us. The call right expires on
February 25, 2013. For purposes of Nordic’s right to put, and our
right to call, all or a portion of Nordic’s equity interest in the Hedrin JV,
the amount of Nordic’s investment is currently $5,000,000.
In
connection with our joint venture agreement, on February 25, 2008, Nordic paid
us a non-refundable fee of $150,000 in exchange for the right to receive a
warrant to purchase up to 14,285,714 shares of our common stock at $0.07 per
share, as adjusted for the 2010 Equity Financing, and as further adjusted from
time to time for stock splits and other specified events.
In
connection with the joint venture agreement, we and Nordic entered into a
registration rights agreement, on February 25, 2008, as modified pursuant to a
letter agreement, dated September 17, 2008, pursuant to which we agreed to file
with the Securities and Exchange Commission, or the SEC, by no later than 10
calendar days following the date on which our Annual Report on Form 10-K for the
year ended December 31, 2007 is required to be filed with the SEC, which was
subsequently waived by Nordic until May 1, 2008, an initial registration
statement registering the resale by Nordic of any shares of our common stock
issuable to Nordic through the exercise of the warrant or the put
right. We filed an initial registration statement on May 1, 2008,
which was declared effective on October 15, 2008.
We also
have agreed to file with the SEC any additional registration statements which
may be required no later than 45 days after the date we first know such
additional registration statement is required; provided, however, that (i) in
the case of the classification by the FDA of Hedrin as a Class II or Class III
medical device described above and the payment in full by Nordic of the related
final milestone payment of $1.25 million, the registration statement with
respect to the additional shares of our common stock relating to such additional
investment must be filed within 45 days after achievement of such
classification; and (ii) in the event we provide Nordic with notice of exercise
of our right to call all or a portion of Nordic's equity interest in the Hedrin
JV, a registration statement with respect to the shares of our common stock
payable to Nordic in connection with such call right (after giving effect to any
reduction in the number of such shares resulting from Nordic's refusal of all or
a portion of such call in accordance with the terms of our joint venture
agreement) must be filed within 16 days after delivery of such notice to
Nordic. If we fail to file a registration statement on time or if a
registration statement is not declared effective by the SEC within 105 days of
the required filing date, or otherwise fail to diligently pursue registration
with the SEC in accordance with the terms of the registration rights agreement,
we will be required to pay as partial liquidated damages and not as a penalty,
to Nordic or its assigns, an amount equal to 0.5% of the amount invested in the
Hedrin JV by Nordic pursuant to the joint venture agreement per month until the
registration rights agreement is declared effective by the SEC; provided,
however, that in no event shall the aggregate amount payable by us exceed 9% of
the amount invested in the Hedrin JV by Nordic under the joint venture
agreement.
31
The
Company was required to file an additional registration statement with 45 days
of Nordic’s investment of an additional $1.25 million in the Hedrin JV in
February 2009. The Company did not meet this requirement as it had
our registration statements pending. The Company has requested a
waiver until May 31, 2009 of Nordic’s registration rights in order to meet this
obligation. Nordic has verbally agreed to the waiver.
As per
the Limited Partnership Agreement between the Company and Nordic (the “LPA”) in
the event that a limited partner in the Hedrin JV (a “Limited Partner”)
determines, in its reasonable goods faith discretion, that the Hedrin JV
requires additional capital for the proper conduct of its business that Limited
Partner shall provide each Limited Partner with a written request for
contribution of such Limited Partner’s proportionate share, in accordance to the
then respective equity ownership in the Hedrin JV, of such requested additional
capital amount.
As per
the terms of the LPA, if a Limited Partner declines to so contribute, elects to
contribute but thereafter fails to do so timely, or elects to contribute and
timely does contribute some, but not all of, its proportionate share of the
requested additional capital amount, the other Limited Partner shall have the
option to contribute the remaining balance of such requested additional capital
amount.
As per
the terms of the LPA, the General Partner shall determine the fair market value
of the shares for purposes of determining how to allocate the number of shares
of the Hedrin JV to be issued in consideration for the contribution of
capital. If the General Partner is unable to determine the fair
market value of the shares, the fair market value for the shares shall be
determined in good faith by the contributing Limited Partner if such amount is
equal to or greater than the most recent valuation of such Hedrin JV
shares.
On
December 31, 2009, Nordic Biotech Venture Fund II (“Nordic”) delivered a written
notice to the Company for a $1,000,000 capital increase to the Hedrin
JV. In January 2010, Nordic made its capital contribution to the
Hedrin JV of $500,000. The Company did not have sufficient funds to
make such a capital contribution within the required time prescribed in the
LPA.
The
General Partner was unable to determine the fair market value of the
shares. The contributing Limited Partner, Nordic, determined in good
faith that the fair market value of the shares is equal to the most recent
valuation. The most recent valuation was the February 2009 investment
of $1,500,000 into the Hedrin JV by Nordic at $5,000 per share. As a
result of Nordic’s investing an additional $500,000 in the Hedrin JV, the
ownership percentages of the Hedrin JV have changed from 50% to Nordic and 50%
for the Company to 52.38% to Nordic and 47.62% for the Company. In
the event that Nordic exercises its option to invest the remaining $500,000 of
the $1,000,000 capital increase then the ownership percentage shall change to
54.55% for Nordic and 45.45% for the Company.
Disagreement
with Nordic
In April
2010 Nordic filed a Schedule 13D/A (the “ Amended 13D ”) with
the SEC. We are not in agreement with the Amended 13D and have written a letter
to Nordic explaining its disagreements. The Amended 13D shows an
aggregate number of shares of the Company’s common stock beneficially owned by
Nordic of 216,666,666, or 65.5%. We believe the correct beneficial
ownership is 85,714,286 shares, or 42.9%. The Amended 13D/A states
that Nordic does not believe the Company’s determination of the anti-dilution
shares accruing to Nordic as a result of the 2010 Equity Financing was neither
reasonable nor made in good faith. As we have previously stated we
believe our determination was both reasonable and made in good
faith. The Amended 13D/A further states that Nordic acquired the
right to purchase an additional 5,555,556 shares of the Company’s common stock
upon exercise of the Nordic Put as a result of Nordic’s making an additional
investment in the Hedrin JV of $500,000 in January 2010. We are not
in agreement with this claim, there is no adjustment to Nordic’s Put as a result
of Nordic making additional capital contributions to the Hedrin
JV. In the letter to Nordic the Company also points out that Nordic’s
valuation suggestions for the warrants issued in the 2010 Equity Financing
ignore the concept of relative value inherent in the Hedrin JV
Agreement.
32
2010
Equity Financing
On March
and April 2010, we raised aggregate gross proceeds of approximately $2.6 million
pursuant to a private placement of our securities (the “2010 Equity
Financing”). We sold an aggregate of 104.3 Units for a
purchase price of $25,000 per Unit. We issued to each Investor units
(the "Units") consisting of 357,143 shares of common stock, $0.001
par value per share of the Company and 535,714 warrants, each of which will
entitle the holder to purchase one additional share of Common Stock for a period
of five years at an exercise price of $0.08 per share. In
addition in April 2010, the holder of the 12% Convertible Note with a stated
value of $400,000 and $22,000 of accrued interest, exercised its option to
convert its Debenture (including all accrued interest thereon) into 16.88
Units. The conversion price was equal to the per Unit purchase price
paid by the Investors in the private placement.
Convertible
12% Note Payable
In
October 2009, we sold a 12% Original Issue Discount Senior Subordinated
Convertible Debenture with a stated value of $400,000 and a warrant to purchase
2,222,222 shares of the Company’s common stock, par value $.001 per
share for a purchase price of $200,000. The Convertible
12% Note is convertible into shares of Common Stock at an initial conversion
price of $0.09 per share, subject to adjustment, or, in the event the Company
issues new securities in connection with a financing, the Convertible 12% Note
may be converted into such new securities at a conversion price equal to the
purchase price paid by the purchasers of such new securities. The
Convertible 12% Note was converted into the 2010 Equity Financing in April 2010
as described above.
Secured
10% Notes Payable
On
September 11, 2008, we issued secured 10% promissory notes to certain of our
directors and officers and an employee for aggregate principal amount of
$70,000. Principal and interest on the notes are payable in cash on
March 10, 2009 unless paid earlier by the Company. In connection with
the issuance of the notes, the Company issued to the noteholders 5-year warrants
to purchase an aggregate of 140,000 shares of our common stock at an exercise
price of $0.20 per share. We granted to the noteholders a continuing
security interest in certain specific refunds, deposits and repayments due to us
and expected to be repaid to us in the next several months. The
secured 10% notes were repaid in February 2009 along with interest
thereon.
Secured
12% Notes Payable
On
February 3, 2009, we completed a private placement of 345 units, with each unit
consisting of Secured 12% Notes in the principal amount of $5,000 and a warrant
to purchase up to 166,667 shares of our common stock at an exercise price of
$.09 per share which expires on December 31, 2013, for aggregate gross proceeds
of $1,725,000. The private placement was completed in three closings
which occurred on November 19, 2008 with respect to 207 units, December 23, 2008
with respect to 56 units and February 3, 2009 with respect to 82
units.
To secure
our obligations under the notes, we entered into a security agreement and a
default agreement with the investors. The security agreement provides that the
notes will be secured by a pledge of our assets other than (i) our interest in
the Hedrin joint venture, including, without limitation, our interest in H
Pharmaceuticals K/S and H Pharmaceuticals General Partner ApS, (ii) our rent
deposit for our former office space, (iii) our refund of a prepayment and (iv)
our tax refund for the 2007 fiscal year from the State of New York and City of
New York. In addition, to provide additional security for our
obligations under the notes, we entered into a default agreement, which provides
that upon an event of default under the notes, we shall, at the request of the
holders of the notes, use our reasonable commercial efforts to either (i) sell a
part or all of our interests in the Hedrin JV or (ii) transfer all or part of
our interest in the Hedrin JV to the holders of the notes, as necessary, in
order to fulfill our obligations under the notes, to the extent required and to
the extent permitted by the applicable Hedrin JV agreements.
33
In
connection with the private placement, we, the placement agent and the investors
entered into a registration rights agreement. Pursuant to the registration
rights agreement, we agreed to file a registration statement to register the
resale of the shares of our common stock issuable upon exercise of the warrants
issued to the investors in the private placement, within 20 days of the final
closing date and to cause the registration statement to be declared effective
within 90 days (or 120 days upon full review by the SEC). During the
three month period ended March 31, 2009, we filed the registration
statement, received a comment letter from the SEC, responded to the SEC comment
letter and re-filed the registration statement. The registration statement
was declared effective by the SEC on April 17, 2009.
Commitments
Development
Commitments
At
present the Company has no development commitments.
Research
and Development Projects
AST-726
Our
wholly owned subsidiary, Ariston, is developing a nasally-delivered Vitamin
B12
remediation treatment which it calls AST-726. AST-726 has demonstrated
pharmacokinetic equivalence to a marketed intramuscular injection product for
Vitamin B12
remediation. Ariston believes that AST-726 may enable both a single,
once-monthly treatment for maintenance of normal Vitamin B12 levels in
deficient patients, and more frequent administration to restore normal levels in
newly diagnosed B12
deficiency. Further, Ariston believes that AST-726 could offer a
convenient, painless, safe and cost-effective treatment for Vitamin B12
deficiency, without the need for intramuscular injections.
Ariston
has positioned AST-726 to currently require only a single, relatively small
Phase III clinical trial prior to submission of a 505(b)(2) new drug application
(“NDA”) to the FDA.
Ariston
has developed a CMC/manufacturing process for AST-726 that Ariston believes
provides a commercially viable stability profile. Ariston has two issued
patents in the United States with respect to AST-726, one of which relates to
its application in Vitamin B12
remediation.
More than
9 million people in the US are deficient in Vitamin B12,
indicating substantial market potential for a facile, convenient, safe and
effective treatment that can replace the need for painful and frequent
intramuscular injections or other less than fully effective delivery forms.
Ariston believes that substantial market opportunity also exists
internationally.
Vitamin
B12
Deficiency-Background of the Disease
Untreated
Vitamin B12
deficiency can result in serious clinical problems including hematological
disorders, such as life-threatening anemias, and a range of central and
peripheral neurological abnormalities such as fatigue, confusion, cognition
impairment, dementia, depression, peripheral neuropathies and gait
disturbances. Neuronal damage may involve peripheral nerves, the spinal
cord and the brain and if the condition is left untreated may become
permanent. Furthermore, clinically asymptomatic patients with low normal
or below normal Vitamin B12 levels
may have changes in blood chemistries, including elevated levels of
methylmalonic acid or homocysteine, known risk factors for other medical
conditions associated with an increased risk of circulatory problems, blood
clots and cardiovascular disease.
The
primary diagnosis of Vitamin B12
deficiency is made when measurement of its blood concentration falls below the
expected normal range of 200 to 900 picograms/ml. Vitamin B12
deficiency is most often caused by pathological conditions that limit the body’s
ability to absorb the vitamin. Such disorders include pernicious anemia,
atrophic gastritis, problems caused by gastric surgical procedures to treat
stomach cancer and obesity, Crohn’s disease and simple age-related
changes. Some studies show the inability to properly absorb Vitamin B12 as a side
effect from chronic use of certain widely prescribed antacid medications such as
Prilosec ® and
diabetes treatments such as Glucophage ®.
Approximately
15% of the elderly and up to 40% of nursing home residents in the U.S. have
Vitamin B12
deficiency. A study of over 11,000 U.S. civilians ages four and older found a 3%
prevalence of Vitamin B12
deficiency in the general population using the 200 picograms/ml deficiency
standard, indicating that approximately 9 million people in the U.S. are in need
of B12
replacement therapy. Some experts advocate a higher deficiency standard of
300-350 picograms/ml on the basis that levels below this coincide with elevated
methylmalonic acid and homocysteine, risk factors for cardiovascular disease as
found in the Framingham Heart Study. On this basis the prevalence of Vitamin
B12
deficiency increases substantially.
34
Current
Treatments for Vitamin B12
Deficiency
Once
Vitamin B12
deficiency is diagnosed by a simple blood test, the goal of treatment is
generally to:
o restore
circulating blood levels to normal as rapidly as possible;
o replenish
and normalize the substantial stores of the vitamin in the body;
and
o institute
a lifelong therapeutic regimen that will maintain normal levels of the
vitamin.
Ariston
believes that parenteral (intramuscular injection) treatment is often considered
the treatment of choice for Vitamin B12
deficiency. Cyanocobalamin is predominantly used for this purpose in the
United States, but hydroxocobalamin, the active ingredient in AST-726, is also
available for pediatrics and for adults for whom injection of cyanocobalamin is
poorly tolerated. Hydroxocobalamin injection is the predominant treatment
for Vitamin B12
deficiency in Europe.
In the
United States, intramuscular injections are generally given by a physician or
nurse, necessitating an office/medical center visit by the patient or a visiting
nurse home call for each treatment. Following a diagnosis of B12
deficiency, injections are required quite frequently in order to restore normal
vitamin levels. Once normalization is achieved, the frequency can be reduced to
once or twice per month. While the treatment is usually highly effective, the
inconvenience and cost of frequent office visits and the pain and side-effects
associated with intramuscular injections are problematic for many
patients.
Intranasal
treatment with Vitamin B12
deficiency seeks to alleviate these problems, but the two intranasal products
currently available in the United States have to be administered on a daily or
weekly basis and are not usually recommended for the treatment of newly
diagnosed patients. Both products are based on
cyanocobalamin.
Oral or
sublingual administration of high doses of Vitamin B12 can
restore deficient patients to normal in certain cases. Such high dose
supplements are generally available in pharmacies and nutrition/health food
stores. Adequate results can almost certainly be obtained when nutritional
insufficiency (e.g., strict vegan diet) is the primary cause of the problem.
However, the normal gastrointestinal tract has a very limited capability to
absorb Vitamin B12 and if
this is compromised, as is the case in many deficient patients, oral or
sublingual supplementation may not be ideal for rapidly restoring circulating
levels and storage depots of the vitamin to normal. In such cases of
pathological Vitamin B12
deficiency, intramuscular injection still often remains the current treatment of
choice.
An
unapproved Vitamin B12 patch is
available in the United States, but Ariston believes that its effectiveness in
moderate to severe Vitamin B12 deficient
patients is substantially untested.
Potential
Advantages of Ariston’s AST-726 Treatment
Ariston
believes that Ariston’s AST-726 treatment has the potential to directly
substitute for and replace the need for injection treatment by applying the
current injection frequency paradigms for both newly diagnosed and normalized
Vitamin B12 deficient
patients. AST-726 is proposed to be self-administered at home by the
patient, without costly, time-consuming and inconvenient visits to a doctor’s
office or medical facility needed for each of the many intramuscular injections
required for life. Because it is delivered through a nasal spray,
additional advantages include freedom from injection pain and reduced anxiety in
individuals, including children and the elderly, who may have fear of
injections. Ariston believes that the delivery profile of AST-726 is
comparable to that of the marketed intramuscular injection, and that therefore
newly diagnosed patients will be able to self-administer the nasal spray on a
daily basis or several times a week to restore their Vitamin B12 status to
normal and will then be self-maintained on a single monthly nasal spray
treatment.
Additional
Clinical Trial Is Needed
AST-726,
a commercial nasal spray formulation of hydroxocobalamin, has satisfactorily
completed preclinical toxicology, and an Investigational New Drug (“IND”)
Application has been filed with the FDA. This product candidate is being
developed utilizing the 505(b)(2) regulatory pathway. AST-726 has also
successfully completed a safety and pharmacokinetic study in healthy volunteers
and an end of Phase II meeting with FDA has been completed. We are
planning a Phase III Vitamin B12
replacement study in the United States. The study is designed to enroll
approximately 40 Vitamin B12 deficient
patients currently treated with injection therapy. Patients will first be
evaluated on injection therapy and then will receive AST-726 by nasal spray on a
monthly basis for 12 weeks. The primary purpose of this study is to
determine that levels of Vitamin B12 in the
patients’ bloodstream remain within the normal range following monthly
administration of AST-726. We anticipate that the data from this study and
additional manufacturing information will support the planned 505(b)(2) new drug
application (“NDA”) filing for AST-726.
35
AST-915
Ariston
is also developing AST-915, an orally delivered treatment for essential
tremor. We acquired global rights to AST-915 as part of the Ariston
acquisition. This product candidate is being studied under a Cooperative
Research and Development Agreement (CRADA) with the National Institutes of
Health (NIH) and a Phase 1 clinical study is currently underway in essential
tremor patients. AST-915 was formerly referred to as “AST-914
metabolite”.
Essential
Tremor
Essential
tremor is a neurological disorder that is characterized by involuntary shaking
of the hands, arms, head, voice, and upper body. The most disabling tremors
occur during voluntary movement, affecting common skills such as writing, eating
and drinking. Essential tremor is often misdiagnosed as Parkinson’s
disease, yet according to the National Institutes of Neurological Disorders and
Stroke, approximately 8 times as many people have essential tremor as have
Parkinson’s. Essential tremor is not confined to the elderly.
Children, newborns, and middle-aged people can also have the
condition.
Market
opportunity
Essential
tremor is the most common involuntary movement disorder, with increasing
incidence as people age. According to the National Institute of Health
(NIH), essential tremor affects 14% of people 65 years and older, which equates
to approximately 5.4 million Americans. There is no cure for essential
tremor and the currently available drug therapies do not work in certain
patients, produce at best a 50% response in others and have significant side
effects. We believe AST-915 may provide a new treatment option for this
serious and prevalent disorder.
We believe that substantial market opportunity also exists
internationally.
Hedrin
In
collaboration with Nordic and through the Hedrin JV we are developing Hedrin for
the treatment of pediculosis (head lice). To date, Hedrin has been
clinically studied in 326 subjects and is currently marketed as a device in
Western Europe and as a pharmaceutical in the United Kingdom
(U.K.).
In a
randomized, controlled, equivalence clinical study conducted in Europe by
T&R, Hedrin was administered to 253 adult and child subjects with head louse
infestation. The study results, published in the British Medical Journal
in June 2005, demonstrated Hedrin’s equivalence when compared to the insecticide
treatment, phenothrin, the most widely used pediculicide in the U.K. In
addition, according to the same study, the Hedrin-treated subjects experienced
significantly less irritation (2%) than those treated with phenothrin
(9%).
An
additional clinical study published in the November 2007 issue of PLoS One, an
international, peer-reviewed journal published by the Public Library of Science
(PLoS), demonstrated Hedrin’s superior efficacy compared to a U.K. formulation
of malathion, a widely used insecticide treatment in both Europe and North
America. In this randomized, controlled, assessor blinded, parallel group
clinical trial, 73 adult and child subjects with head lice infestations were
treated with Hedrin or malathion liquid. Using intent-to-treat analysis,
Hedrin achieved a statistically significant cure rate of 70% compared to 33%
with malathion liquid. Using the per-protocol analysis Hedrin achieved a
highly statistically significant cure rate of 77% compared to 35% with
malathion. In Europe it has been widely documented that head lice had
become resistant to European formulations of malathion, and we believe this
resistance had influenced these study results. To date, there have been no
reports of resistance to U.S. formulations of malathion. Additionally,
Hedrin treated subjects experienced no irritant reactions, and Hedrin showed
clinical equivalence to malathion in its ability to inhibit egg hatching.
Overall, investigators and study subjects rated Hedrin as less odorous, easier
to apply, and easier to wash out, and 97% of Hedrin treated subjects stated they
were significantly more inclined to use the product again versus 31% of those
using malathion.
Two new,
unpublished Hedrin studies were completed by T&R in 2008. In the
first, Hedrin achieved a 100% kill rate in vitro, including in malathion
resistant head lice. In the other, a clinical field study conducted in
Manisa province, a rural area of Western Turkey, Hedrin was administered to 36
adult and child subjects with confirmed head lice infestations. Using per
protocol analysis, Hedrin achieved a 97% cure rate. Using intent-to-treat
analysis, Hedrin achieved a 92% cure rate since 2 subjects were eliminated due
to protocol violations. No subjects reported any adverse
events.
36
In the U.S., Manhattan Pharmaceuticals, through the Hedrin JV, is
pursuing the development of Hedrin as a medical device. In January 2009,
the U.S. Food and Drug Administration (“FDA”) Center for Devices and
Radiological Health (“CDRH”) notified H Pharmaceuticals that Hedrin had been
classified as a Class III medical device. A Class III designation means
that a Premarket Approval (“PMA”) Application will need to be obtained before
Hedrin can be marketed in the U.S. The Company expects to be required to
complete at least one clinical trial as part of that PMA Application. At a
July 2009 meeting with the FDA, the FDA requested of the Hedrin JV that the
confirmatory clinical trials consist of two parallel studies. The Hedrin
JV estimates that each of the parallel studies will consist of 60
patients. In April 2010, the Hedrin JV received
correspondence from the FDA in which the FDA raised certain questions about the
non-clinical aspects of Hedrin (including certain deficiencies in
safety documentation that will require further study). The Hedrin JV is in the
process of responding to those questions and will not be able to commence the
confirmatory clinical trials, and the Hedrin JV's application to
conduct those clinical trials will not be accepted by the FDA, unless
and until such
questions are responded to, to the satisfaction of the
FDA.
To date,
we have incurred $1,084,000 of project costs for the development of
Hedrin. None of these costs were incurred during the six month period
ended June 30, 2010. We do not expect to incur any future costs as the
Hedrin JV is now responsible for all costs associated with Hedrin.
Topical
GEL for Psoriasis
As a
result of our merger with Tarpan Therapeutics in 2005, we held an exclusive,
worldwide license to develop and commercialize Topical PTH (1-34) for the
treatment of psoriasis. Tarpan acquired the exclusive, worldwide rights
pursuant to a 2004 license agreement with IGI, Inc (“IGI”).
In April
2006, we encountered a stability issue with the original topical PTH (1-34)
product which utilized IGI’s Novosome ®
formulation technology. In order to resolve that stability issue we
created a new topical gel version of PTH (1-34).
In
September 2007, the U.S. FDA accepted our Investigational New Drug (“IND”)
application for this new gel formulation of Topical PTH (1-34), and in October
2007, we initiated and began dosing subjects in a Phase 2a clinical study of
Topical PTH (1-34) for the treatment of psoriasis. This U.S.,
multi-center, randomized, double-blind, vehicle-controlled, parallel group study
was designed to evaluate safety and preliminary efficacy of Topical PTH (1-34)
in patients with mild to moderate psoriasis. Approximately 54 subjects
were enrolled and randomized to receive one of two dose levels of Topical PTH
(1-34), or the gel vehicle (placebo), for an 8 week treatment period. In
this study the vehicle was the topical gel (“GEL”) without the active
ingredient, PTH (1-34).
In July
2008, we announced the results of a Phase 2a clinical study where PTH (1-34)
failed to show statistically or clinically meaningful improvements in psoriasis
as compared to the vehicle (placebo). The Company has conducted no further
clinical activities with PTH (1-34), terminated the agreement with IGI in May
2009 and has no further financial liability or commitment to IGI under the
license agreement.
The gel
vehicle (placebo) used in the above-mentioned study is the Company’s proprietary
topical GEL which unexpectedly showed evidence of psoriasis improving
properties. At the end of week 2, 15% of study subjects treated with the
GEL achieved a clear or almost clear state. At the end of week 4, 20% of
subjects treated with the GEL had achieved a clear or almost clear state, and at
the end of week 8, 25% of subjects had achieved a clear or almost clear
state. The Company owns worldwide rights to this topical GEL and is
exploring the possibility of developing it as an OTC product for mild
psoriasis.
To date,
we have incurred $6,504,000 of project costs related to our development of
Topical PTH (1-34). These project costs have been incurred since April 1,
2005, the date of the Tarpan Therapeutics acquisition. None of these costs
were incurred during the six month period ended June 30, 2010.
37
Employment
Agreement
None.
Off-Balance
Sheet Arrangements
We have
not entered into any off-balance sheet arrangements.
Critical
Accounting Policies
In
December 2001, the SEC requested that all registrants discuss their most
“critical accounting policies” in management’s discussion and analysis of
financial condition and results of operations. The SEC indicated that a
“critical accounting policy” is one which is both important to the portrayal of
the company’s financial condition and results and requires management’s most
difficult, subjective or complex judgments, often as a result of the need to
make estimates about the effect of matters that are inherently
uncertain.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect certain reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of expenses during the
reporting period. Actual results could differ from those
estimates.
Research
and Development Expenses
All
research and development costs are expensed as incurred and include costs of
consultants who conduct research and development on behalf of the Company and
its subsidiaries. Costs related to the acquisition of technology rights
and patents for which development work is still in process are expensed as
incurred and considered a component of research and development
costs.
The
Company often contracts with third parties to facilitate, coordinate and perform
agreed upon research and development of a new drug. To ensure that
research and development costs are expensed as incurred, the Company records
monthly accruals for clinical trials and preclinical testing costs based on the
work performed under the contracts.
These
contracts typically call for the payment of fees for services at the initiation
of the contract and/or upon the achievement of certain milestones. This
method of payment often does not match the related expense recognition resulting
in either a prepayment, when the amounts paid are greater than the related
research and development costs expensed, or an accrued liability, when the
amounts paid are less than the related research and development costs
expensed.
Share-Based
Compensation
We have
stockholder-approved stock incentive plans for employees, directors, officers
and consultants. Prior to January 1, 2006, we accounted for the employee,
director and officer plans using the intrinsic value method. Effective January
1, 2006, we adopted the share-based payment method for employee options using
the modified prospective transition method. This new method of accounting for
stock options eliminated the option to use the intrinsic value method and
required us to expense the fair value of all employee options over the vesting
period. Under the modified prospective transition method, we recognized
compensation cost which includes a) period compensation cost related to
share-based payments granted prior to, but not yet vested, as of January 1,
2006, based on the grant date fair value estimated in accordance with the
original provisions; and b) period compensation cost related to share-based
payments granted on or after January 1, 2006, based on the grant date fair value
estimated in accordance with the new accounting methodology. In accordance with
the modified prospective method, we have not restated prior period
results.
38
Our
exposure to market risk is confined to our cash and cash equivalents. We have
attempted to minimize risk by investing in high-quality financial instruments,
primarily money market funds with no security having an effective duration
longer than 90 days. If the market interest rate decreases by 100 basis points
or 1%, the fair value of our cash and cash equivalents portfolio would have
minimal to no impact on the carrying value of our portfolio. We did not hold any
derivative instruments as of June 30, 2010, and we have never held such
instruments in the past.
Item
4T. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
As of
June 30, 2010, we carried out an evaluation, under the supervision and with the
participation of our Principal Executive Officer, of the effectiveness of the
design and operation of our disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”)). Based upon that evaluation, our Chief Operating and
Financial Officer concluded that our disclosure controls and procedures were
effective as of that date to ensure that information required to be disclosed in
our reports filed or submitted under the Exchange Act is recorded , processed,
summarized and reported within the time periods specified in the SEC’s rules and
forms, and to ensure that information required to be disclosed by us in such
reports is accumulated and communicated to the our management, including our
Chief Operating and Financial Officer, as appropriate to allow timely decisions
regarding required disclosure
Our
disclosure controls or internal controls over financial reporting were designed
to provide only reasonable assurance that such disclosure controls or internal
control over financial reporting will prevent all errors or all instances of
fraud, even as the same are improved to address any deficiencies. The design of
any system of controls is based in part upon certain assumptions about the
likelihood of future events, and there can be only reasonable, not absolute
assurance that any design will succeed in achieving its stated goals under all
potential future conditions. A control system, no matter how well designed and
operated, can provide only reasonable, not absolute, assurance that the control
system’s objectives will be met. Over time, controls may become inadequate
because of changes in conditions or deterioration in the degree of compliance
with policies or procedures. Further, the design of a control system must
reflect the fact that there are resource constraints, and the benefits of
controls must be considered relative to their costs.
Because
of the inherent limitation of a cost-effective control system, misstatements due
to error or fraud may occur and not be detected. These inherent limitations
include the realities that judgments in decision-making can be faulty, and that
breakdowns can occur because of a simple error or mistake. Controls can also be
circumvented by the individual acts of some persons, by collusion of two or more
people, or by management override of the controls.
Changes
in Internal Control
During
the quarter ended June 30, 2010, there were no changes in internal controls over
financial reporting that have materially affected, or are reasonably likely to
materially affect, our internal controls over financial
reporting.
39
Item
1. Legal Proceedings
None.
Item
1A. Risk Factors
We
are controlled by current officers, directors and principal stockholders; a
dispute with our Hedrin JV joint venture partner may adversely affect the
Company.
Our
directors, executive officers and principal stockholders beneficially own
approximately 20 percent of our outstanding voting stock and, including shares
underlying outstanding options and warrants. In addition, Nordic
Biotech Venture Fund has the right to acquire up to 85,714,285 shares of our
common stock which would result in Nordic owning approximately 43% of our common
stock as of March 23, 2010 (although, as described in Note 18 to our financial
statements at and for the Years ended December 231, 2009 and 2008, and as
described in an amendment to Nordic’s 13-D filing with respect to the Company,
an anti-dilution calculation with respect to this amount has been disputed by
Nordic; Nordic alleges that using an alternative approach to valuing the
Company’s recent private placement of stock and warrants, an approach that the
Company believes is neither correct nor appropriate, as a result of the
anti-dilution adjustment Nordic would beneficially own 85,714,286 shares of our
common stock, which represents 42.9% of our common stock as of March 23,
2010). Through its stock ownership, its right to acquire additional
shares, its substantial control over the management of the Hedrin JV (which
includes the ability to terminate our management contract with the Hedrin JV),
Nordic has the ability to exert substantial influence over the election of our
Board of Directors, the outcome of issues submitted to our stockholders, the
development of Hedrin and our ability, as a company, to benefit from the
successful development of Hedrin. Even without the exercise of its rights
to acquire additional shares of our common stock, our directors, officers and
principal stockholders, taken as a whole, have the ability to exert substantial
influence over the election of our Board of Directors and the outcome of issues
submitted to our stockholders. Any dispute with Nordic, including the
dispute concerning the appropriate valuation methodology for the antidilution
calculation, may adversely affect the Company’s operations and the Company’s
ability to raise additional capital in the future, and may divert the Company’s
limited management time and attention,
Item
6. Exhibits
Exhibit
No.
|
Description
|
|
31.1
|
Certification
of Principal Executive and Financial Officer
|
|
32.1
|
Certifications
of Principal Executive and Financial Officer pursuant to Section 906 of
the Sarbanes-Oxley Act of
2002.
|
SIGNATURES
MANHATTAN
PHARMACEUTICALS, INC.
|
||
Date:
August 16, 2010
|
By:
|
/s/ Michael
G. McGuinness
|
Michael
G. McGuinness
|
||
Principal
Executive Officer
|
Index to Exhibits Filed with
this Report
Exhibit
No.
|
Description
|
|
31.1
|
Certification
of Principal Executive and Financial Officer.
|
|
32.1
|
Certifications
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
42