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.)
|
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
|
17
|
Item
3.
|
Quantitative
and Qualitative Disclosure About Market Risk
|
25
|
Item
4.
|
Controls
and Procedures
|
25
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1A.
|
Risk
Factors
|
26
|
Item
6.
|
Exhibits
|
26
|
Signatures
|
28
|
June
30,
|
December
31,
|
||||||
|
2007
|
2006
|
|||||
(Unaudited)
|
(See
Note 1)
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
4,790,589
|
$
|
3,029,118
|
|||
Prepaid
expenses
|
352,657
|
264,586
|
|||||
Total
current assets
|
5,143,246
|
3,293,704
|
|||||
Property
and equipment, net
|
62,904
|
83,743
|
|||||
Other
assets
|
70,506
|
70,506
|
|||||
Total
assets
|
$
|
5,276,656
|
$
|
3,447,953
|
|||
Liabilities
and Stockholders’ Equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,001,849
|
$
|
1,393,296
|
|||
Accrued
expenses
|
1,528,406
|
550,029
|
|||||
Total
liabilities
|
2,530,255
|
1,943,325
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders’
equity:
|
|||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares
issued and
outstanding at June 30, 2007 and December 31, 2006
|
—
|
—
|
|||||
Common
stock, $.001 par value. Authorized 150,000,000 shares; 70,474,232
and
60,120,038 shares issued and outstanding at June 30, 2007 and December
31,
2006, respectively
|
70,474
|
60,120
|
|||||
Additional
paid-in capital
|
53,101,402
|
44,411,326
|
|||||
Deficit
accumulated during the development stage
|
(50,425,475
|
)
|
(42,966,818
|
)
|
|||
Total
stockholders’ equity
|
2,746,401
|
1,504,628
|
|||||
Total
liabilities and stockholders' equity
|
$
|
5,276,656
|
$
|
3,447,953
|
Cumulative
|
||||||||||||||||
period
from
|
||||||||||||||||
August 6, 2001
|
||||||||||||||||
(inception) to
|
||||||||||||||||
Three Months ended June 30,
|
Six months ended June 30,
|
June
30,
|
||||||||||||||
2007
|
2006
|
2007
|
2006
|
2007
|
||||||||||||
|
||||||||||||||||
Revenue
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||
Costs
and expenses:
|
||||||||||||||||
Research
and development
|
3,871,634
|
1,570,905
|
5,551,082
|
3,257,346
|
23,504,438
|
|||||||||||
General
and administrative
|
1,052,374
|
786,391
|
1,967,098
|
1,597,336
|
12,211,191
|
|||||||||||
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
|
4,924,008
|
2,357,296
|
7,518,180
|
4,854,682
|
50,065,544
|
|||||||||||
Operating
loss
|
(4,924,008
|
)
|
(2,357,296
|
)
|
(7,518,180
|
)
|
(4,854,682
|
)
|
(50,065,544
|
)
|
||||||
Other
(income) expense:
|
||||||||||||||||
Interest
and other income
|
(29,608
|
)
|
(86,483
|
)
|
(59,998
|
)
|
(185,189
|
)
|
(769,714
|
)
|
||||||
Interest
expense
|
-
|
238
|
475
|
238
|
26,033
|
|||||||||||
Realized
gain on sale of marketable equity securities
|
-
|
—
|
—
|
(490
|
)
|
(76,032
|
)
|
|||||||||
Total
other income
|
(29,608
|
)
|
(86,245
|
)
|
(59,523
|
)
|
(185,441
|
)
|
(819,713
|
)
|
||||||
Net
loss
|
(4,894,400
|
)
|
(2,271,051
|
)
|
(7,458,657
|
)
|
(4,669,241
|
)
|
(49,245,831
|
)
|
||||||
Preferred
stock dividends (including imputed amounts)
|
-
|
—
|
—
|
—
|
(1,179,644
|
)
|
||||||||||
Net
loss applicable to common shares
|
$
|
(4,894,400
|
)
|
$
|
(2,271,051
|
)
|
$
|
(7,458,657
|
)
|
$
|
(4,669,241
|
)
|
$
|
(50,425,475
|
)
|
|
Net
loss per common share:
|
||||||||||||||||
Basic
and diluted
|
$
|
(0.07
|
)
|
$
|
(0.04
|
)
|
$
|
(0.11
|
)
|
$
|
(0.08
|
)
|
||||
Weighted
average shares of common stock outstanding:
|
||||||||||||||||
Basic
and diluted
|
70,463,543
|
60,116,174
|
65,377,865
|
60,104,500
|
Deficit
|
Dividends
|
Total
|
||||||||||||||||||||||||||||||||
Series A
|
accumulated
|
payable
in
|
Accumulated
|
stock-
|
||||||||||||||||||||||||||||||
convertible
|
Additional
|
during
|
Series
A
|
other
|
Unearned
|
holders'
|
||||||||||||||||||||||||||||
preferred stock
|
Common stock
|
paid-in
|
Subscription
|
development
|
preferred
|
comprehensive
|
consulting
|
equity
|
||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
capital
|
receivable
|
stage
|
shares
|
income
(loss)
|
services
|
(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
|
)
|
(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
|
7,843,967
|
—
|
—
|
—
|
—
|
—
|
7,854,153
|
|||||||||||||||||||||||
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
|
|||||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
706,549
|
—
|
—
|
—
|
—
|
—
|
706,549
|
|||||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
10,327
|
15
|
7,219
|
—
|
—
|
—
|
—
|
—
|
7,234
|
|||||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
5,589
|
—
|
(6
|
)
|
—
|
—
|
—
|
—
|
—
|
(6
|
)
|
|||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
-
|
—
|
(7,458,657
|
)
|
—
|
—
|
—
|
(7,458,657
|
)
|
|||||||||||||||||||||
Balance
at June 30, 2007
|
—
|
$
|
—
|
70,474,232
|
$
|
70,474
|
$
|
53,101,402
|
$
|
—
|
$
|
(50,425,475
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
2,746,401
|
|
Cumulative
|
|||||||||
period
from
|
||||||||||
August 6, 2001
|
||||||||||
(inception) to
|
||||||||||
Six
months ended June 30,
|
June
30,
|
|||||||||
2007
|
2006
|
2007
|
||||||||
|
||||||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(7,458,657
|
)
|
$
|
(4,669,241
|
)
|
$
|
(49,245,831
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Share-based
compensation
|
706,549
|
619,128
|
2,630,576
|
|||||||
Shares
issued in connection with in-licensing agreement
|
112,500
|
—
|
112,500
|
|||||||
Amortization
of intangible assets
|
—
|
—
|
145,162
|
|||||||
Gain
on sale of marketable equity securities
|
—
|
(490
|
)
|
(76,032
|
)
|
|||||
Depreciation
|
29,974
|
29,484
|
177,454
|
|||||||
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
in prepaid expenses and other current assets
|
(88,071
|
)
|
(780,863
|
)
|
(294,412
|
)
|
||||
Increase
in other assets
|
—
|
—
|
(70,506
|
)
|
||||||
Increase/(decrease)
in accounts payable
|
(371,447
|
)
|
345,243
|
1,422,063
|
||||||
Increase
in accrued expenses
|
978,377
|
203,778
|
988,085
|
|||||||
Net
cash used in operating activities
|
(6,090,775
|
)
|
(4,252,961
|
)
|
(30,021,620
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchase
of property and equipment
|
(9,135
|
)
|
(12,832
|
)
|
(230,636
|
)
|
||||
Cash
acquired (paid) in connection with acquisitions, net
|
—
|
—
|
(26,031
|
)
|
||||||
Proceeds
from sale (payments for purchase)of short-term investments,
net
|
—
|
500,000
|
435,938
|
|||||||
Proceeds
from sale of license
|
—
|
—
|
200,001
|
|||||||
Net
cash provided by (used in) investing activities
|
(9,135
|
)
|
487,168
|
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
|
7,854,153
|
(15,256
|
)
|
25,898,230
|
||||||
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 (used in) provided by financing activities
|
7,861,381
|
(15,256
|
)
|
34,432,937
|
||||||
Net
(decrease) increase in cash and cash equivalents
|
1,761,471
|
(3,781,049
|
)
|
4,790,589
|
||||||
Cash
and cash equivalents at beginning of period
|
3,029,118
|
9,826,336
|
—
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
4,790,589
|
$
|
6,045,287
|
$
|
4,790,589
|
||||
Supplemental
disclosure of cash flow information:
|
||||||||||
Interest
paid
|
$
|
475
|
$
|
238
|
$
|
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 agreement
|
112,500
|
—
|
112,500
|
|||||||
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
|
(1) |
SUMMARY
OF SIGNIFICANT ACCOUNTING
POLICIES
|
(2) |
LIQUIDITY
|
(3) |
COMPUTATION
OF NET LOSS PER COMMON
SHARE
|
(4) |
SHARE-BASED
COMPENSATION
|
Three months ended June 30,
|
Six months ended June 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
General
and administrative expense:
|
|||||||||||||
Share-based
employee compensation cost
|
$
|
249,623
|
$
|
252,361
|
$
|
471,544
|
$
|
444,977
|
|||||
Share-based
consultant and non-employee (credit) cost
|
—
|
(28,450
|
)
|
10,550
|
(22,861
|
)
|
|||||||
$
|
249,623
|
$
|
223,911
|
$
|
482,094
|
$
|
422,116
|
||||||
Research
and development expense
|
|||||||||||||
Share-based
employee compensation cost
|
$
|
121,531
|
$
|
105,147
|
$
|
231,449
|
$
|
200,472
|
|||||
Share-based
consultant and non-employee (credit) cost
|
185
|
(21,842
|
)
|
(6,994
|
)
|
(3,460
|
)
|
||||||
$
|
121,716
|
$
|
83,305
|
$
|
224,455
|
$
|
197,012
|
||||||
Total
share-based cost
|
$
|
371,339
|
$
|
307,216
|
$
|
706,549
|
$
|
619,128
|
Three
months ended June 30,
|
Six
months ended June 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Expected
Volatility
|
79.7
- 93.2
|
%
|
55
|
%
|
79.7
- 93.2
|
%
|
55
|
%
|
|||||
Dividend
yield
|
—
|
—
|
—
|
—
|
|||||||||
Expected
term (in years)
|
6
- 8
|
4
|
6
- 8
|
4
|
|||||||||
Risk-free
interest rate
|
4.56%
- 4.96
|
%
|
4.88
|
%
|
4.56%
- 4.96
|
%
|
4.88
|
%
|
Shares
|
Weighted
average
exercise
price
|
Weighted
Average Remaining Contractual
Term
(years)
|
Aggregate
Intrinsic
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
|
|||||||||||||
June
30, 2007
|
8,233,838
|
$
|
1.25
|
7.43
|
$
|
387,171
|
|||||||
Options
exercisable at
|
|||||||||||||
June
30, 2007
|
5,102,546
|
$
|
1.30
|
6.95
|
$
|
341,821
|
|||||||
Weighted-average
|
|||||||||||||
fair
value of options
|
|||||||||||||
granted
during the
|
|||||||||||||
six
months ended
|
|||||||||||||
June
30, 2007
|
$
|
0.63
|
(5) |
COMMITMENTS
|
(6) |
RECENTLY
COMPLETED IN-LICENSING
TRANSACTIONS
|
(7) |
PRIVATE
PLACEMENT OF COMMON SHARES
|
(8) |
SUBSEQUENT
EVENTS
|
·
|
Topical
PTH (1-34) for the treatment of
psoriasis;
|
·
|
Altoderm,
a proprietary formulation of topical cromolyn sodium for the
treatment of
atopic dermatitis;
|
·
|
Altolyn,
a proprietary site specific tablet formulation of oral cromolyn
sodium for
the treatment of mastocytosis;
|
·
|
and
Hedrin, a novel, non-insecticide treatment for head
lice.
|
Six month
period ended June 30, 2007 |
Six month
period ended June 30, 2006 |
Increase
(decrease) |
% Increase
(decrease) |
||||||||||
Costs
and expenses
|
|||||||||||||
Research
and development
|
|||||||||||||
Stock
based compensation
|
$
|
224,000
|
$
|
197,000
|
$
|
27,000
|
13.7
|
%
|
|||||
In-license
and related fees
|
$
|
1,803,000
|
$
|
250,000
|
$
|
1,553,000
|
621.2
|
%
|
|||||
Other
research and development expense
|
$
|
3,524,000
|
$
|
2,810,000
|
$
|
714,000
|
25.4
|
%
|
|||||
Total
research and development expense
|
$
|
5,551,000
|
$
|
3,257,000
|
$
|
2,294,000
|
70.4
|
%
|
|||||
General
and administrative
|
|||||||||||||
Stock
based compensation
|
$
|
482,000
|
$
|
422,000
|
$
|
60,0000
|
14.2
|
%
|
|||||
Other
general and administrative expense
|
$
|
1,485,000
|
$
|
1,175,000
|
$
|
310,000
|
26.4
|
%
|
|||||
Total
general and administrative expense
|
$
|
1,967,000
|
$
|
1,597,000
|
$
|
370,000
|
23.2
|
%
|
|||||
Other
income
|
$
|
60,000
|
$
|
185,000
|
$
|
(125,000
|
)
|
(67.6
|
)%
|
||||
Net
loss
|
$
|
7,458,000
|
$
|
4,669,000
|
$
|
2,789,000
|
59.7
|
%
|
Quarter
ended June 30, 2007 |
Quarter
ended June 30, 2006 |
Increase
(decrease) |
% Increase
(decrease) |
||||||||||
Costs
and expenses
|
|||||||||||||
Research
and development
|
|||||||||||||
Stock
based compensation
|
$
|
122,000
|
$
|
83,000
|
$
|
39,000
|
47.0
|
%
|
|||||
In-license
and related fees
|
$
|
1,803,000
|
$
|
250,000
|
$
|
1,553,000
|
621.2
|
%
|
|||||
Other
research and development expense
|
$
|
1,947,000
|
$
|
1,238,000
|
$
|
709,000
|
57.3
|
%
|
|||||
Total
research and development expense
|
$
|
3,872,000
|
$
|
1,571,000
|
$
|
2,301,000
|
146.5
|
%
|
|||||
General
and administrative
|
|||||||||||||
Stock
based compensation
|
$
|
250,000
|
$
|
224,000
|
$
|
26,000
|
11.6
|
%
|
|||||
Other
general and administrative expense
|
$
|
802,000
|
$
|
562,000
|
$
|
240,000
|
42.7
|
%
|
|||||
Total
general and administrative expense
|
$
|
1,052,000
|
$
|
786,000
|
$
|
266,000
|
33.8
|
%
|
|||||
Other
income
|
$
|
30,000
|
$
|
86,000
|
$
|
(56,000
|
)
|
(65.1
|
)%
|
||||
Net
loss
|
$
|
4,894,000
|
$
|
2,271,000
|
$
|
2,623,000
|
115.5
|
%
|
Nominee
|
Votes For
|
Votes Withheld
|
|||||
Douglas
Abel
|
35,536,892
|
65,132
|
|||||
Neil
Herskowitz
|
35,376,093
|
225,931
|
|||||
Malcolm
Hoenlein
|
35,518,495
|
83,529
|
|||||
Timothy
McInerney
|
35,538,692
|
63,332
|
|||||
Joan
Pons Gimbert
|
35,154,378
|
447,646
|
|||||
Richard
I. Steinhart
|
35,529,736
|
72,288
|
|||||
Michael
Weiser
|
34,493,245
|
1,108,779
|
Exhibit No.
|
Description
|
|
4.1
|
Form
of warrant issued to investors in March 30, 2007 private placement
(incorporated by reference to Exhibit 4.1 of the Company’s Form 8-K filed
April 5, 2007).
|
|
4.2
|
Form
of warrant issued to placement agent in connection with the
March 30, 2007
private placement (incorporated by reference to Exhibit 4.2
of the
Company’s Form 8-K filed April 5, 2007).
|
|
10.1
|
Summary
of terms of non-employee director compensation (incorporated
by reference
to Exhibit 10.1 of the Company’s Form 8-K filed February 5,
2007).
|
10.2
|
Form
of subscription agreement between the Company and investors
in the March
30, 2007 private placement (incorporated by reference to Exhibit
10.1 of
the Company’s Form 8-K filed April 5, 2007).
|
|
10.3
|
Exclusive
License Agreement for “Altoderm” between Thornton & Ross Ltd. and
Manhattan Pharmaceuticals, Inc. dated April 3, 2007.
|
|
10.4
|
Exclusive
License Agreement for “Altolyn” between Thornton & Ross Ltd. and
Manhattan Pharmaceuticals, Inc. dated April 3, 2007.
|
|
10.5
|
Exclusive
License Agreement for “Hedrin” between Thornton & Ross Ltd., Kerris,
S.A. and Manhattan Pharmaceuticals, Inc. dated June 26,
2007.
|
|
10.6
|
Supply
Agreement for “Hedrin” between Thornton & Ross Ltd. and Manhattan
Pharmaceuticals, Inc. dated June 26, 2007.
|
|
31.1
|
Certification
of Chief Executive Officer
|
|
31.2
|
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: August 14, 2007 | By: | /s/ Douglas Abel |
Douglas Abel |
||
President and Chief Executive Officer |
|
|
|
Date: August 14, 2007 | By: | /s/ Michael G. McGuinness |
Michael G. McGuinness |
||
Chief Financial Officer |
Description
|
||
10.3
|
Exclusive License Agreement for “Altoderm” between Thornton & Ross Ltd. and Manhattan Pharmaceuticals, Inc. dated April 3, 2007. | |
|
||
10.4
|
Exclusive License Agreement for “Altolyn” between Thornton & Ross Ltd. and Manhattan Pharmaceuticals, Inc. dated April 3, 2007. | |
|
||
10.5
|
Exclusive License Agreement for “Hedrin” between Thornton & Ross Ltd., Kerris, S.A. and Manhattan Pharmaceuticals, Inc. dated June 26, 2007. | |
|
||
10.6
|
Supply Agreement for “Hedrin” between Thornton & Ross Ltd. and Manhattan Pharmaceuticals, Inc. dated June 26, 2007. | |
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.
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1. |
I
have reviewed this Quarterly Report on Form 10-Q of Manhattan
Pharmaceuticals, Inc. (the “Registrant”);
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2. |
Based
on my knowledge, this report does not contain any untrue statement
of a
material fact or omit to state a material fact necessary to make
the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
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3. |
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects
the
financial condition, results of operations and cash flows of the
Registrant as of, and for, the periods presented in this report;
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4.
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The
Registrant’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the Registrant
and have:
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(a)
Designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the Registrant, including
its consolidated subsidiaries, is made known to us by others within
those
entities, particularly during the period in which this report is
being
prepared;
|
(b)
Evaluated the effectiveness of the Registrant's disclosure controls
and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the
end of
the period covered by this report based on such evaluation;
and
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(c)
Disclosed in this report any change in the Registrant’s internal control
over financial reporting that occurred during the Registrant’s most recent
fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely
to
materially affect, the Registrant’s internal control over financial
reporting; and
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5. |
The
Registrant’s other certifying officer(s) and I have disclosed, based on
our most recent evaluation of internal control over financial reporting,
to the Registrant’s auditors and the audit committee of the Registrant’s
board of directors (or persons performing the equivalent functions):
|
(a)
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the Registrant’s ability to record,
process, summarize and report financial information;
and
|
(b)
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the Registrant’s internal control
over financial
reporting.
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Date: August 14, 2007 | /s/ Douglas Abel | |
Douglas Abel |
||
President and Chief Executive Officer |
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Manhattan
Pharmaceuticals, Inc. (the “Registrant”);
|
2. |
Based
on my knowledge, this report does not contain any untrue statement
of a
material fact or omit to state a material fact necessary to make
the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3. |
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects
the
financial condition, results of operations and cash flows of the
Registrant as of, and for, the periods presented in this report;
|
4. |
The
Registrant's other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) for the Registrant and have:
|
(a)
Designed such disclosure controls and procedures, or caused such
disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the Registrant,
including
its consolidated subsidiaries, is made known to us by others within
those
entities, particularly during the period in which this report is
being
prepared;
|
(b)
Evaluated the effectiveness of the Registrant's disclosure controls
and
procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the
end of
the period covered by this report based on such evaluation; and
|
(c)
Disclosed in this report any change in the Registrant's internal
control
over financial reporting that occurred during the Registrant's most
recent
fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely
to
materially affect, the Registrant’s internal control over financial
reporting; and
|
5. |
The
Registrant's other certifying officer(s) and I have disclosed, based
on
our most recent evaluation of internal control over financial reporting,
to the Registrant’s auditors and the audit committee of the Registrant’s
board of directors (or persons performing the equivalent functions):
|
(a)
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the Registrant’s ability to record,
process, summarize and report financial information;
and
|
(b)
Any fraud, whether or not material, that involves management or other
employees who have a significant role in the Registrant’s internal control
over financial reporting.
|
Date: August 14, 2007 | /s/ Douglas Abel | |
Michael G. McGuinness |
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Chief Financial Officer |
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Date: August 14, 2007 | /s/ Douglas Abel | |
Douglas Abel |
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President and Chief Executive Officer |
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Date: August 14, 2007 | /s/ Michael G. McGuinness | |
Michael G. McGuinness |
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Chief Financial Officer |