x |
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
o |
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
o
|
Accelerated
filer
o
|
Non-accelerated
filer
x
|
Page
|
||||
PART
I
|
FINANCIAL
INFORMATION
|
|||
Item
1.
|
Unaudited
Condensed Consolidated Balance Sheets
|
4
|
||
Unaudited
Condensed Consolidated Statements of Operations
|
5
|
|||
Unaudited
Condensed Consolidated Statement of Stockholders’ Equity
(Deficiency)
|
6
|
|||
Unaudited
Condensed Consolidated Statements of Cash Flows
|
7
|
|||
Notes
to Unaudited Condensed Consolidated Financial Statements
|
8
|
|||
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
18
|
||
Item
3.
|
Quantitative
and Qualitative Disclosure About Market Risk
|
28
|
||
Item
4T.
|
Controls
and Procedures
|
28
|
||
PART
II
|
OTHER
INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
29
|
||
Item
1A.
|
Risk
Factors
|
29
|
||
Item
6.
|
Exhibits
|
29
|
||
Signatures
|
30
|
· |
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
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.
|
September
30,
|
December
31,
|
||||||
2007
|
2006
|
||||||
(Unaudited)
|
(See
Note 1)
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
2,032,655
|
$
|
3,029,118
|
|||
Prepaid
expenses
|
202,161
|
264,586
|
|||||
Total
current assets
|
2,234,816
|
3,293,704
|
|||||
Property
and equipment, net
|
52,472
|
83,743
|
|||||
Other
assets
|
70,506
|
70,506
|
|||||
Total
assets
|
$
|
2,357,794
|
$
|
3,447,953
|
|||
Liabilities
and Stockholders’ Equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
852,490
|
$
|
1,393,296
|
|||
Accrued
expenses
|
938,656
|
550,029
|
|||||
Total
current liabilities
|
1,791,146
|
1,943,325
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders’
equity:
|
|||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares issued
and
outstanding at September 30, 2007 and December 31, 2006,
respectively
|
-
|
-
|
|||||
Common
stock, $.001 par value. Authorized 150,000,000 shares; 70,624,232
and
60,120,038 shares issued and outstanding at September 30, 2007 and
December 31, 2006, respectively
|
70,624
|
60,120
|
|||||
Additional
paid-in capital
|
53,590,920
|
44,411,326
|
|||||
Deficit
accumulated during the development stage
|
(53,094,896
|
)
|
(42,966,818
|
)
|
|||
Total
stockholders’ equity
|
566,648
|
1,504,628
|
|||||
Total
liabilities and stockholders' equity
|
$
|
2,357,794
|
$
|
3,447,953
|
Three
Months
ended
September 30,
|
Nine
months
ended
September 30,
|
Cumulative
period from August 6, 2001 (inception) to September
30,
|
||||||||||||||
2007
|
2006
|
2007
|
2006
|
2007
|
||||||||||||
Revenue
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
—
|
||||||
Costs
and expenses:
|
||||||||||||||||
Research
and development
|
1,808,958
|
1,041,693
|
7,360,040
|
4,299,039
|
25,313,396
|
|||||||||||
General
and administrative
|
898,063
|
923,755
|
2,865,161
|
2,521,091
|
13,109,254
|
|||||||||||
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
|
2,707,021
|
1,965,448
|
10,225,201
|
6,820,130
|
52,772,565
|
|||||||||||
Operating
loss
|
(2,707,021
|
)
|
(1,965,448
|
)
|
(10,225,201
|
)
|
(6,820,130
|
)
|
(52,772,565
|
)
|
||||||
Other
(income) expense:
|
||||||||||||||||
Interest
and other income
|
(37,600
|
)
|
(68,740
|
)
|
(97,598
|
)
|
(253,929
|
)
|
(807,314
|
)
|
||||||
Interest
expense
|
-
|
714
|
475
|
952
|
26,033
|
|||||||||||
Realized
gain on sale of marketable equity securities
|
-
|
-
|
-
|
(490
|
)
|
(76,032
|
)
|
|||||||||
Total
other income
|
(37,600
|
)
|
(68,026
|
)
|
(97,123
|
)
|
(253,467
|
)
|
(857,313
|
)
|
||||||
Net
loss
|
(2,669,421
|
)
|
(1,897,422
|
)
|
(10,128,078
|
)
|
(6,566,663
|
)
|
(51,915,252
|
)
|
||||||
Preferred
stock dividends (including imputed amounts)
|
-
|
-
|
-
|
-
|
(1,179,644
|
)
|
||||||||||
Net
loss applicable to common shares
|
$
|
(2,669,421
|
)
|
$
|
(1,897,422
|
)
|
$
|
(10,128,078
|
)
|
$
|
(6,566,663
|
)
|
$
|
(53,094,896
|
)
|
|
Net
loss per common share:
|
||||||||||||||||
Basic
and diluted
|
$
|
(0.04
|
)
|
$
|
(0.03
|
)
|
$
|
(0.15
|
)
|
$
|
(0.11
|
)
|
||||
Weighted
average shares of common stock outstanding:
|
||||||||||||||||
Basic
and diluted
|
70,591,623
|
60,120,038
|
67,134,882
|
60,109,737
|
|
|
Series
A
convertible preferred stock |
|
Common
stock
|
|
Additional
paid-in capital
|
|
Subscription
receivable
|
|
Deficit
accumulated during development
stage
|
|
payable
in Series A preferred
shares
|
|
Accumulated
other comprehensive
income
(loss)
|
|
Unearned
consulting
services
|
|
Total
stock- holders'equity
(deficiency)
|
|
|||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|||||||||||||||||||
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
|
)
|
(4,000
|
)
|
(56,796
|
)
|
—
|
—
|
—
|
(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
|
1,000,000
|
1,000
|
—
|
—
|
9,045,176
|
—
|
—
|
—
|
—
|
—
|
9,046,176
|
|||||||||||||||||||||||
Imputed
preferred stock dividend
|
418,182
|
—
|
(418,182
|
)
|
—
|
—
|
||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,960,907
|
)
|
—
|
—
|
—
|
(5,960,907
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2003
|
1,000,000
|
1,000
|
23,362,396
|
23,362
|
14,289,535
|
—
|
(7,473,205
|
)
|
—
|
(7,760
|
)
|
—
|
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
|
24,901
|
25
|
—
|
—
|
281,073
|
—
|
—
|
(282,388
|
)
|
—
|
—
|
(1,290
|
)
|
|||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(170,528
|
)
|
(171
|
)
|
1,550,239
|
1,551
|
(1,380
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
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
|
854,373
|
854
|
28,309,187
|
28,309
|
18,083,208
|
—
|
(13,955,035
|
)
|
303,411
|
13,237
|
(20,168
|
)
|
4,453,816
|
|||||||||||||||||||||
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
|
41,781
|
42
|
—
|
—
|
477,736
|
—
|
—
|
(479,074
|
)
|
—
|
—
|
(1,296
|
)
|
|||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(896,154
|
)
|
(896
|
)
|
8,146,858
|
8,147
|
(7,251
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
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 issued at $0.84 and $0.90, 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
|
|||||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
1,078,185
|
—
|
—
|
—
|
—
|
—
|
1,078,185
|
|||||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
10,327
|
15
|
7,219
|
—
|
—
|
—
|
—
|
—
|
7,234
|
|||||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
5,589
|
—
|
(6
|
)
|
—
|
—
|
—
|
—
|
—
|
(6
|
)
|
|||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
-
|
—
|
(10,128,078
|
)
|
—
|
—
|
—
|
(10,128,078
|
)
|
|||||||||||||||||||||
Balance
at September 30, 2007
|
—
|
$
|
—
|
70,624,232
|
$
|
70,624
|
$
|
53,590,920
|
$
|
—
|
$
|
(53,094,896
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
566,648
|
Cumulative
|
||||||||||
period
from
|
||||||||||
August
6, 2001
|
||||||||||
Nine
months
ended
|
(inception)
to
|
|||||||||
September
30,
|
September
30,
|
|||||||||
2007
|
2006
|
2007
|
||||||||
|
||||||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(10,128,078
|
)
|
$
|
(6,566,663
|
)
|
$
|
(51,915,252
|
)
|
|
Adjustments
to reconcile net loss to
|
||||||||||
net
cash used in operating activities:
|
||||||||||
Share-based
compensation
|
1,078,185
|
945,858
|
3,002,212
|
|||||||
Shares
issued in connection with in-licensing agreements
|
232,500
|
-
|
232,500
|
|||||||
Amortization
of intangible assets
|
-
|
-
|
145,162
|
|||||||
Gain
on sale of marketable equity securities
|
-
|
(490
|
)
|
(76,032
|
)
|
|||||
Depreciation
|
40,406
|
44,581
|
187,886
|
|||||||
Non
cash portion of in-process research and development charge
|
-
|
-
|
11,721,623
|
|||||||
Loss
on impairment and disposition of intangible assets
|
-
|
-
|
2,462,108
|
|||||||
Other
|
-
|
-
|
5,590
|
|||||||
Changes
in operating assets and liabilities, net of acquisitions:
|
||||||||||
(Increase)/decrease
in prepaid expenses and other current assets
|
62,425
|
(554,274
|
)
|
(143,916
|
)
|
|||||
Increase
in other assets
|
-
|
-
|
(70,506
|
)
|
||||||
Increase/(decrease)
in accounts payable
|
(520,806
|
)
|
(531,941
|
)
|
1,272,704
|
|||||
Increase
in accrued expenses
|
388,627
|
280,405
|
398,335
|
|||||||
Net
cash used in operating activities
|
(8,846,741
|
)
|
(6,382,524
|
)
|
(32,777,586
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchase
of property and equipment
|
(9,135
|
)
|
(15,872
|
)
|
(230,636
|
)
|
||||
Cash
paid in connection with acquisitions, net
|
-
|
-
|
(26,031
|
)
|
||||||
Proceeds
from sale of short-term investments, net
|
-
|
500,000
|
435,938
|
|||||||
Proceeds
from sale of license
|
-
|
-
|
200,001
|
|||||||
Net
cash (used in) provided by investing activities
|
(9,135
|
)
|
484,128
|
379,272
|
||||||
Cash
flows from financing activities:
|
||||||||||
Repayments
of notes payable to stockholders
|
-
|
-
|
(884,902
|
)
|
||||||
Payment
for fractional shares for preferred stock dividends
|
-
|
-
|
(2,286
|
)
|
||||||
Proceeds
related to sale of common stock, net
|
7,852,185
|
(15,256
|
)
|
25,896,262
|
||||||
Proceeds
from sale of preferred stock, net
|
-
|
-
|
9,046,176
|
|||||||
Proceeds
from exercise of warrants and stock options
|
7,228
|
-
|
138,219
|
|||||||
Other,
net
|
-
|
-
|
237,500
|
|||||||
Net
cash provided by (used in) financing activities
|
7,859,413
|
(15,256
|
)
|
34,430,969
|
||||||
Net
(decrease) increase in cash and cash equivalents
|
(996,463
|
)
|
(5,913,652
|
)
|
2,032,655
|
|||||
Cash
and cash equivalents at beginning of period
|
3,029,118
|
9,826,336
|
—
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
2,032,655
|
$
|
3,912,684
|
$
|
2,032,655
|
||||
Supplemental
disclosure of cash flow information:
|
||||||||||
Interest
paid
|
$
|
475
|
$
|
952
|
$
|
26,033
|
||||
Supplemental
disclosure of noncash investing and financing activities:
|
||||||||||
Common
stock issued in satisfaction of accounts payable
|
$
|
20,000
|
$
|
-
|
$
|
770,000
|
||||
Imputed
preferred stock dividend
|
-
|
-
|
418,182
|
|||||||
Preferred
stock dividends accrued
|
-
|
-
|
761,462
|
|||||||
Conversion
of preferred stock to common stock
|
-
|
-
|
9,046,176
|
|||||||
Preferred
stock dividends paid by issuance of shares
|
-
|
-
|
759,134
|
|||||||
Issuance
of common stock for acquisitions
|
-
|
-
|
13,389,226
|
|||||||
Issuance
of common stock in connection with in-licensing agreements
|
232,500
|
-
|
232,500
|
|||||||
Marketable
equity securities received in connection with
|
||||||||||
sale
of license
|
-
|
-
|
359,907
|
|||||||
Net
liabilities assumed over assets acquired in business
combination
|
-
|
-
|
(675,416
|
)
|
||||||
Cashless
exercise of warrants
|
6
|
27
|
33
|
Three
months ended September 30,
|
Nine
months ended
September 30, |
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
General
and administrative expense:
|
|||||||||||||
Share-based
employee compensation costs
|
$
|
254,870
|
$
|
225,394
|
$
|
726,414
|
$
|
670,371
|
|||||
Share-based
consultant and non-employee (credits) costs
|
—
|
(2,962
|
)
|
10,550
|
(25,823
|
)
|
|||||||
Total
general and administrative expense
|
$
|
254,870
|
$
|
222,432
|
$
|
736,964
|
$
|
644,548
|
|||||
Research
and development expense:
|
|||||||||||||
Share-based
employee compensation costs
|
$
|
125,533
|
$
|
108,111
|
$
|
356,983
|
$
|
308,583
|
|||||
Share-based
consultant and non-employee (credits) costs
|
(8,767
|
)
|
(3,813
|
)
|
(15,762
|
)
|
(7,273
|
)
|
|||||
Total
research and development expense
|
$
|
116,766
|
$
|
104,298
|
$
|
341,221
|
$
|
301,310
|
|||||
Total
share-based costs
|
$
|
371,636
|
$
|
326,730
|
$
|
1,078,185
|
$
|
945,858
|
Three
months ended September 30,
|
Nine
months ended September 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Expected
Volatility
|
93
|
%
|
55
|
%
|
80%
- 93
|
%
|
55
|
%
|
|||||
Dividend
yield
|
—
|
—
|
—
|
—
|
|||||||||
Expected
term (in years)
|
6
- 8
|
6
|
6
- 8
|
6
|
|||||||||
Risk-free
interest rate
|
4.38%
- 4.96
|
%
|
4.88
|
%
|
4.38%
- 4.96
|
%
|
4.88
|
%
|
Weighted
|
|||||||||||||
Weighted
|
Average
|
||||||||||||
average
|
Remaining
|
Aggregate
|
|||||||||||
exercise
|
Contractual
|
Intrinsic
|
|||||||||||
Shares
|
price
|
Term
(years)
|
Value
|
||||||||||
Outstanding
at
|
|||||||||||||
December
31, 2006
|
7,000,504
|
$
|
1.31
|
||||||||||
Granted
|
|||||||||||||
Officers
|
870,000
|
||||||||||||
Directors
|
300,000
|
||||||||||||
Employees
|
172,500
|
||||||||||||
Total
Granted
|
1,342,500
|
0.88
|
|||||||||||
Exercised
|
-
|
-
|
|||||||||||
Cancelled
|
(109,166
|
)
|
0.95
|
||||||||||
Outstanding
at
|
|||||||||||||
September
30, 2007
|
8,233,838
|
$
|
1.25
|
7.19
|
$
|
-
|
|||||||
Options
exercisable at
|
|||||||||||||
September
30, 2007
|
5,247,546
|
$
|
1.29
|
6.74
|
$
|
-
|
|||||||
Weighted-average
fair value of options granted during the nine months ended
September 30,
2007
|
$
|
0.63
|
·
|
Topical
PTH (1-34) for the treatment of
psoriasis;
|
·
|
Altoderm,
a proprietary formulation of topical cromolyn sodium for the treatment
of
atopic dermatitis;
|
·
|
Hedrin,
a novel, non-insecticide treatment for head
lice;
|
·
|
and
Altolyn, a proprietary site specific tablet formulation of oral cromolyn
sodium for the treatment of
mastocytosis.
|
Nine
months ended September
30,
|
Increase
|
%
Increase
|
|||||||||||
2007
|
2006
|
(decrease)
|
(decrease)
|
||||||||||
Costs
and expenses
|
|||||||||||||
Research
and development
|
|||||||||||||
Stock
based compensation
|
$
|
341,000
|
$
|
301,000
|
$
|
40,000
|
13.3
|
%
|
|||||
In-license
and related fees
|
$
|
1,804,000
|
$
|
250,000
|
$
|
1,554,000
|
621.6
|
%
|
|||||
Consulting
costs related to in-license activities
|
$
|
134,000
|
$
|
-
|
$
|
134,000
|
N/A
|
||||||
Other
research and development expense
|
$
|
5,081,000
|
$
|
3,748,000
|
$
|
1,333,000
|
35.6
|
%
|
|||||
Total
research and development expense
|
$
|
7,360,000
|
$
|
4,299,000
|
$
|
3,061,000
|
71.2
|
%
|
|||||
General
and administrative
|
|||||||||||||
Stock
based compensation
|
$
|
737,000
|
$
|
645,000
|
$
|
92,000
|
14.3
|
%
|
|||||
Other
general and administrative expense
|
$
|
2,128,000
|
$
|
1,876,000
|
$
|
252,000
|
13.4
|
%
|
|||||
Total
general and administrative expense
|
$
|
2,865,000
|
$
|
2,521,000
|
$
|
344,000
|
13.6
|
%
|
|||||
Other
income
|
$
|
97,000
|
$
|
253,000
|
$
|
(156,000
|
)
|
-61.7
|
%
|
||||
Net
loss
|
$
|
(10,128,000
|
)
|
$
|
(6,567,000
|
)
|
$
|
3,561,000
|
54.2
|
%
|
Quarter
ended September 30,
|
|
Increase
|
|
%
Increase
|
|
||||||||
|
|
2007
|
|
2006
|
|
(decrease)
|
|
(decrease)
|
|||||
Costs
and expenses
|
|||||||||||||
Research
and development
|
|||||||||||||
Stock
based compensation
|
$
|
117,000
|
$
|
104,000
|
$
|
13,000
|
12.5
|
%
|
|||||
Other
research and development expense
|
$
|
1,692,000
|
$
|
938,000
|
$
|
754,000
|
80.4
|
%
|
|||||
Total
research and development expense
|
$
|
1,809,000
|
$
|
1,042,000
|
$
|
767,000
|
73.6
|
%
|
|||||
General
and administrative
|
|||||||||||||
Stock
based compensation
|
$
|
255,000
|
$
|
222,000
|
$
|
33,000
|
14.9
|
%
|
|||||
Other
general and administrative expense
|
$
|
643,000
|
$
|
702,000
|
$
|
(59,000
|
)
|
-8.4
|
%
|
||||
Total
general and administrative expense
|
$
|
898,000
|
$
|
924,000
|
$
|
(26,000
|
)
|
-2.8
|
%
|
||||
Other
income
|
$
|
37,000
|
$
|
68,000
|
$
|
(31,000
|
)
|
-45.6
|
%
|
||||
Net
loss
|
$
|
(2,670,000
|
)
|
$
|
(1,898,000
|
)
|
$
|
772,000
|
40.7
|
%
|
Exhibit
No.
|
Description
|
|
31.1
|
Certification
of Chief Executive Officer
|
|
Certification
of Chief Financial Officer
|
||
32.1
|
Certifications
of Chief Executive Officer and Chief Financial Officer pursuant
to Section
906 of the Sarbanes-Oxley Act of
2002.
|
MANHATTAN
PHARMACEUTICALS, INC.
|
||
|
|
|
Date: November 13, 2007 | By: | /s/ Douglas Abel |
Douglas
Abel
President
and Chief Executive Officer
|
Date: November 13, 2007 | By: | /s/ Michael G. McGuinness |
Michael
G. McGuinness
Chief
Financial Officer
|
Exhibit
No.
|
Description
|
|
31.1
|
Certification
of Chief Executive Officer
|
|
Certification
of Chief Financial Officer
|
||
32.1
|
Certifications
of Chief Executive Officer and Chief Financial Officer pursuant
to Section
906 of the Sarbanes-Oxley Act of
2002.
|