x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
¨
|
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
Delaware
(State
or other jurisdiction of
incorporation
or organization)
|
36-3898269
(I.R.S.
Employer Identification No.)
|
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨
|
Smaller
reporting company x
|
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
|
|
·
|
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.
|
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 |
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 |
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
|
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
|
)
|
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 |
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 |
1.
|
SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
|
|
·
|
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.
|
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
|
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 |
2.
|
LIQUIDITY
|
3.
|
COMPUTATION OF NET INCOME (LOSS)
PER COMMON SHARE
|
4.
|
SHARE-BASED
COMPENSATION
|
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 |
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 | % |
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 |
5.
|
JOINT
VENTURE
|
6.
|
NOTES
PAYABLE
|
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 |
7.
|
2010 EQUITY
FINANCING
|
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
|
8.
|
DERIVATIVE
LIABILITY
|
9.
|
SUBSEQUENT
EVENT
|
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 | % |
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 | % |
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.
|
MANHATTAN
PHARMACEUTICALS, INC.
|
||
Date:
August 16, 2010
|
By:
|
/s/ Michael
G. McGuinness
|
Michael
G. McGuinness
|
||
Principal
Executive Officer
|
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.
|