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
|
36-3898269
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
(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
|
8
|
|
Notes
to Unaudited Condensed Consolidated Financial Statements
|
9
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
|
21
|
Item
3.
|
Quantitative
and Qualitative Disclosure About Market Risk
|
37
|
Item
4.
|
Controls
and Procedures
|
37
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1.
|
Legal
Proceedings
|
38
|
Item
1A.
|
Risk
Factors
|
38
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
39
|
Item
6.
|
Exhibits
|
39
|
Signatures
|
40
|
· |
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,
2008
|
December
31,
2007
|
|||||
|
(Unaudited)
|
(See
Note 1)
|
|||||
Assets
|
|||||||
Current
assets:
|
|
|
|||||
Cash
and cash equivalents
|
$
|
576,354
|
$
|
649,686
|
|||
Prepaid
expenses and other current assets
|
135,540
|
215,852
|
|||||
Total
current assets
|
711,894
|
865,538
|
|||||
|
|||||||
Investment
in Hedrin JV
|
142,408
|
-
|
|||||
Property
and equipment, net
|
34,912
|
44,533
|
|||||
Other
assets
|
84,126
|
70,506
|
|||||
Total
assets
|
$
|
973,340
|
$
|
980,577
|
|||
|
|||||||
Liabilities
and Stockholders’ Deficiency
|
|||||||
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
617,346
|
$
|
1,279,485
|
|||
Accrued
expenses
|
849,746
|
592,177
|
|||||
Total
current liabilities
|
1,467,092
|
1,871,662
|
|||||
Exchange
obligation
|
2,953,230
|
-
|
|||||
Total
liabilities
|
4,420,322
|
1,871,662
|
|||||
Commitments
and contingencies
|
|||||||
|
|||||||
Stockholders’
deficiency:
|
|||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares
issued and
outstanding at June 30, 2008 and December 31, 2007
|
|||||||
Common
stock, $.001 par value. Authorized 300,000,000 shares; 70,624,232
shares
issued and outstanding at June 30, 2008 and December 31,
2007
|
70,624
|
70,624
|
|||||
Additional
paid-in capital
|
54,483,025
|
54,037,361
|
|||||
Deficit
accumulated during the development stage
|
(58,000,631
|
)
|
(54,999,070
|
)
|
|||
Total
stockholders’ deficiency
|
(3,446,982
|
)
|
(891,085
|
)
|
|||
|
|||||||
Total
liabilities and stockholders' deficiency
|
$
|
973,340
|
$
|
980,577
|
Three months ended June 30,
|
Six months ended June 30,
|
Cumulative
period from
August 6, 2001
(inception) to
June 30
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
2008
|
||||||||||||
Costs
and expenses:
|
||||||||||||||||
Research
and development
|
$
|
565,728
|
$
|
3,871,634
|
$
|
1,365,799
|
$
|
5,551,082
|
$
|
27,854,842
|
||||||
General
and administrative
|
901,538
|
1,052,374
|
1,715,598
|
1,967,098
|
15,567,961
|
|||||||||||
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
|
1,467,266
|
4,924,008
|
3,081,397
|
7,518,180
|
57,772,718
|
|||||||||||
Operating
loss
|
(1,467,266
|
)
|
(4,924,008
|
)
|
(3,081,397
|
)
|
(7,518,180
|
)
|
(57,772,718
|
)
|
||||||
Other
(income) expense:
|
||||||||||||||||
Equity
in loss of Hedrin JV
|
87,718
|
—
|
107,593
|
—
|
107,593
|
|||||||||||
Interest
and other income
|
(132,772
|
)
|
(29,608
|
)
|
(187,429
|
)
|
(59,998
|
)
|
(1,009,327
|
)
|
||||||
Interest
expense
|
—
|
—
|
—
|
475
|
26,034
|
|||||||||||
Realized
gain on sale of marketable equity securities
|
—
|
—
|
—
|
—
|
(76,032
|
)
|
||||||||||
Total
other income
|
(45,054
|
)
|
(29,608
|
)
|
(79,836
|
)
|
(59,523
|
)
|
(951,731
|
)
|
||||||
Net
loss
|
(1,422,212
|
)
|
(4,894,400
|
)
|
(3,001,561
|
)
|
(7,458,657
|
)
|
(56,820,987
|
)
|
||||||
Preferred
stock dividends (including imputed amounts)
|
—
|
—
|
—
|
—
|
(1,179,644
|
)
|
||||||||||
Net
loss applicable to common shares
|
$
|
(1,422,212
|
)
|
$
|
(4,894,400
|
)
|
$
|
(3,001,561
|
)
|
$
|
(7,458,657
|
) |
(58,000,631
|
)
|
||
Net
loss per common share:
|
||||||||||||||||
Basic
and diluted
|
$
|
(0.02
|
)
|
$
|
(0.07
|
)
|
$
|
(0.04
|
)
|
$
|
(0.11
|
)
|
||||
Weighted
average shares of common stock outstanding:
|
||||||||||||||||
Basic
and diluted
|
70,624,232
|
70,463,543
|
70,624,232
|
65,377,865
|
Series
A convertible preferred stock
|
Series
A convertible preferred stock
|
Common
stock
|
Common
stock
|
Additional
paid-in capital |
Subscription
receivable
|
Deficit
accumulated during development stage
|
Dividends
payable in
Series A
preferred stock
|
Accumulated
other comprehensive income (loss)
|
Unearned
consulting services
|
Total
stockholders’ equity (deficiency)
|
||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
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
|
Series
A convertible preferred stock
|
Series
A convertible preferred stock
|
Common
stock
|
Common
stock
|
Additional
paid-in capital
|
Subscription
receivable
|
Deficit
accumulated during development stage
|
Dividends
payable in Series A preferred stock
|
Accumulated
other comprehensive income (loss)
|
Unearned
consulting services
|
Total
stockholders’ equity (deficiency)
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
||||||||||||||||||||||||
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 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 to in connection with in-licensing agreement at
$0.90 per
share
|
—
|
—
|
125,000
|
125
|
112,375
|
—
|
—
|
—
|
—
|
—
|
112,500
|
|||||||||||||||||||||||
Common
stock issued to 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
|
—
|
—
|
—
|
—
|
295,664
|
—
|
—
|
—
|
—
|
—
|
295,664
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
-
|
—
|
(3,001,561
|
)
|
—
|
—
|
—
|
(3,001,561
|
)
|
|||||||||||||||||||||
Balance
at June 30, 2008
|
—
|
$
|
—
|
70,624,232
|
$
|
70,624
|
$
|
54,483,025
|
$
|
—
|
$
|
(58,000,631)
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(3,446,982
|
)
|
Cumulative
|
||||||||||
period from
|
||||||||||
August 6, 2001
|
||||||||||
Six months ended June 30,
|
(inception) to
|
|||||||||
2008
|
2007
|
June 30, 2008
|
||||||||
Cash flows
from operating activities:
|
|
|
|
|||||||
Net
loss
|
$
|
(3,001,561
|
)
|
$
|
(7,458,657
|
)
|
$
|
(56,820,987
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Equity
in loss of Hedrin JV
|
107,593
|
—
|
107,593
|
|||||||
Share-based
compensation
|
295,664
|
706,549
|
3,660,647
|
|||||||
Shares
issued in connection with in-licensing agreement
|
—
|
112,500
|
232,500
|
|||||||
Warrants
issued to consultant
|
—
|
—
|
83,670
|
|||||||
Amortization
of intangible assets
|
—
|
—
|
145,162
|
|||||||
Gain
on sale of marketable equity securities
|
—
|
(76,032
|
)
|
|||||||
Depreciation
|
15,631
|
29,974
|
211,456
|
|||||||
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
|
2,962
|
—
|
8,552
|
|||||||
Changes
in operating assets and liabilities, net of acquisitions:
|
||||||||||
(Increase)/decrease
in prepaid expenses and other current assets
|
80,311
|
(88,071
|
)
|
(77,296
|
)
|
|||||
Increase
in other assets
|
—
|
-
|
(70,506
|
)
|
||||||
Increase
/(decrease) in accounts payable
|
(662,139
|
)
|
(371,447
|
)
|
1,037,559
|
|||||
Increase
in accrued expenses
|
257,569
|
978,377
|
309,425
|
|||||||
Net
cash used in operating activities
|
(2,903,970
|
)
|
(6,090,775
|
)
|
(37,064,526
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchase
of property and equipment
|
(8,972
|
)
|
(9,135
|
)
|
(239,607
|
)
|
||||
Cash
paid in connection with acquisitions
|
—
|
—
|
(26,031
|
)
|
||||||
Net
cash provided from the purchase and sale of short-term
investments,
net
|
—
|
—
|
435,938
|
|||||||
Proceeds
from the sale of license
|
—
|
—
|
200,001
|
|||||||
Investment
in Hedrin JV’s general partner
|
(13,620
|
)
|
—
|
(13,620
|
)
|
|||||
Net
cash (used in) provided by investing activities
|
(22,592
|
)
|
(9,135
|
)
|
356,681
|
|||||
Cash
flows from financing activities:
|
||||||||||
Repayments
of notes payable to stockholders
|
—
|
—
|
(884,902
|
)
|
||||||
Proceeds
related to sale of common stock, net
|
—
|
7,854,153
|
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
|
|||||||
Proceeds
from the Hedrin JV Agreement, net
|
2,703,230
|
—
|
2,703,230
|
|||||||
Sale
of warrant
|
150,000
|
—
|
150,000
|
|||||||
Other,
net
|
—
|
—
|
235,214
|
|||||||
Net
cash provided by financing activities
|
2,853,230
|
7,861,381
|
37,284,199
|
|||||||
Net
(decrease) increase in cash and cash equivalents
|
(73,332
|
)
|
1,761,471
|
576,354
|
||||||
Cash
and cash equivalents at beginning of period
|
649,686
|
3,029,118
|
—
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
576,354
|
$
|
4,790,589
|
$
|
576,354
|
||||
|
||||||||||
Supplemental
disclosure of cash flow information:
|
||||||||||
Interest
paid
|
$
|
—
|
$
|
475
|
$
|
26,033
|
||||
Supplemental
disclosure of noncash investing and financing activities:
|
||||||||||
Common
stock issued in satisfaction of accounts payable
|
$
|
—
|
$
|
20,000
|
$
|
750,000
|
||||
Imputed
preferred stock dividend
|
—
|
—
|
418,182
|
|||||||
Preferred
stock dividends accrued
|
—
|
—
|
761,462
|
|||||||
Preferred
stock dividends paid by issuance of shares
|
—
|
—
|
9,046,176
|
|||||||
Conversion
of preferred stock to common stock
|
—
|
—
|
759,134
|
|||||||
Issuance
of common stock for acquisitions
|
—
|
—
|
13,389,226
|
|||||||
Issuance
of common stock in connection with in-licensing agreement
|
—
|
112,500
|
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
|
)
|
||||||
Investment
in Hedrin JV
|
250,000
|
—
|
250,000
|
|||||||
Cashless
exercise of warrants
|
—
|
6
|
33
|
Three
months ended June 30,
|
|
Six
months ended June 30,
|
|
||||||||||
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|||||
General
and administrative expense:
|
|||||||||||||
Share-based
employee compensation cost
|
$
|
75,362
|
$
|
249,623
|
$
|
215,405
|
$
|
471,544
|
|||||
Share-based
consultant and non-employee (credit) cost
|
—
|
—
|
—
|
10,550
|
|||||||||
$
|
75,362
|
$
|
249,623
|
$
|
215,405
|
$
|
482,094
|
||||||
Research
and development expense:
|
|||||||||||||
Share-based
employee compensation cost
|
$
|
27,735
|
$
|
121,531
|
$
|
80,000
|
$
|
231,449
|
|||||
Share-based
consultant and non-employee (credit) cost
|
(287
|
)
|
185
|
259
|
(6,994
|
)
|
|||||||
$
|
27,448
|
$
|
121,716
|
$
|
80,259
|
$
|
224,455
|
||||||
Total
share-based cost
|
$
|
102,810
|
$
|
371,339
|
$
|
295,664
|
$
|
706,549
|
Three
months ended June 30,
|
Six
months ended June 30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Expected
Volatility
|
92.3
|
%
|
79.7
- 93.2
|
%
|
92.3
|
%
|
79.7
- 93.2
|
%
|
|||||
Dividend
yield
|
-
|
-
|
-
|
-
|
|||||||||
Expected
term (in years)
|
6
|
6
- 8
|
6
|
6
- 8
|
|||||||||
Risk-free
interest rate
|
2.81
|
%
|
4.56%
- 4.96
|
%
|
2.81
|
%
|
4.56%
- 4.96
|
%
|
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(years) |
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
at December 31, 2007
|
8,033,808
|
$
|
1.25
|
||||||||||
Granted:
|
|||||||||||||
Officers
|
2,400,000
|
||||||||||||
Directors
|
375,000
|
||||||||||||
Employees
|
192,500
|
||||||||||||
Total
granted
|
2,967,500
|
0.17
|
|||||||||||
Exercised
|
-
|
||||||||||||
Cancelled
|
(224,972
|
)
|
0.17
|
||||||||||
Outstanding
at June 30, 2008
|
10,766,336
|
$
|
0.93
|
7.46
|
$
|
-
|
|||||||
Exercisable
at June 30, 2008
|
8,004,692
|
$
|
1.12
|
6.80
|
|||||||||
Weighted
average fair value of options granted during the six months ended
June 30,
2008
|
$
|
0.13
|
·
|
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, through Hedrin
Pharmaceuticals K/S, a joint venture between the Company Nordic Biotech
Fund II K/S ;
|
·
|
and
Altolyn, a proprietary site specific tablet formulation of oral cromolyn
sodium for the treatment of
mastocytosis.
|
Six
Months ended June 30,
|
|||||||||||||
2008
|
2007
|
Increase
(decrease)
|
%
Increase
(decrease)
|
||||||||||
COSTS
AND EXPENSES
|
|||||||||||||
Research
and development
|
|||||||||||||
Share-based
compensation
|
$
|
80,000
|
$
|
224,000
|
($144,000
|
)
|
(64
|
)%
|
|||||
Other
research and development expense
|
$
|
1,286,000
|
$
|
5,327,000
|
($4,041,000
|
)
|
(76
|
)%
|
|||||
Total
research and development expense
|
$
|
1,366,000
|
$
|
5,551,000
|
($4,185,000
|
)
|
(75
|
)%
|
|||||
General
and administrative
|
|||||||||||||
Share-based
compensation
|
$
|
215,000
|
$
|
482,000
|
($267,000
|
)
|
(55
|
)%
|
|||||
Other
general and administrative expense
|
$
|
1,500,000
|
$
|
1,485,000
|
$
|
15,000
|
1
|
%
|
|||||
Total
general and administrative expense
|
$
|
1,715,000
|
$
|
1,967,000
|
$
|
(252,000
|
)
|
(13
|
)%
|
||||
Other
income
|
$
|
79,000
|
$
|
59,000
|
$
|
20,000
|
34
|
%
|
|||||
NET
LOSS
|
($3,002,000
|
)
|
($7,459,000
|
)
|
$
|
(4,457,000
|
)
|
(60
|
)%
|
Quarter
ended June 30,
|
|||||||||||||
2008
|
2007
|
Increase
(decrease)
|
%
Increase
(decrease)
|
||||||||||
COSTS
AND EXPENSES
|
|||||||||||||
Research
and development
|
|||||||||||||
Share-based
compensation
|
$
|
27,000
|
$
|
122,000
|
($95,000
|
)
|
(77
|
)%
|
|||||
Other
research and development expense
|
$
|
539,000
|
$
|
3,750,000
|
($3,211,000
|
)
|
(86
|
)%
|
|||||
Total
research and development expense
|
$
|
566,000
|
$
|
3,872,000
|
($3,306,000
|
)
|
(85
|
)%
|
|||||
General
and administrative
|
|||||||||||||
Share-based
compensation
|
$
|
75,000
|
$
|
250,000
|
($175,000
|
)
|
(70
|
)%
|
|||||
Other
general and administrative expense
|
$
|
826,000
|
$
|
803,000
|
$
|
23,000
|
3
|
%
|
|||||
Total
general and administrative expense
|
$
|
901,000
|
$
|
1,053,000
|
$
|
(152,000
|
)
|
(14
|
)%
|
||||
Other
income
|
$
|
45,000
|
$
|
30,000
|
$
|
15,000
|
50
|
%
|
|||||
NET
LOSS
|
($1,442,000
|
)
|
($4,895,000
|
)
|
($3,473,000
|
)
|
(71
|
)%
|
(i)
|
The
stockholders elected six directors to serve until the next Annual
Meeting
of Stockholders. The stockholders present in person or by proxy cast
the
following numbers of votes in connection with the election of directors,
resulting in the election of all
nominees:
|
Nominee
|
Votes for
|
Votes witheld
|
|||||
Douglas
Abel
|
54,245,717
|
424,966
|
|||||
Neil
Herskowitz
|
54,032,617
|
638,066
|
|||||
Malcolm
Hoenlein
|
54,039,512
|
631,171
|
|||||
Timothy
McInerney
|
54,255,717
|
414,966
|
|||||
Richard
Steinhart
|
54,048,592
|
622,091
|
|||||
Michael
Weiser
|
54,168,352
|
502,331
|
(ii)
|
The
stockholders ratified the amendment of the Company’s Certificate of
Incorporation to increase the the authorized shares of the Company’s
coomon stock from 150,000,000 to 300,000,000.The stockholders cast
52,639,703 votes for the amendment, 1,686,294 votes against the amendment
and 344,686 votes abstained.
|
(iii)
|
The
stockholders ratified the appointment of JH Cohn LLP as our independent
registered public accounting firm for fiscal 2008. The stockholders
cast
54,526,569 votes for the appointment, 107,037 votes against the
appointment and 37,077 votes
abstained.
|
Exhibit
No.
|
Description
|
|
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 19, 2008
|
By:
/s/
Douglas
Abel
|
|
Douglas
Abel
|
||
President
and Chief Executive Officer
|
||
Date:
August 19, 2008
|
By:
/s/
Michael G.
McGuinness
|
|
Michael
G. McGuinness
|
||
Chief
Operating and Financial Officer
|
Exhibit
No.
|
Description
|
|
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.
|
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) and 15d-15(e)) for the Registrant
and have:
|
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):
|
Date:
August 19, 2008
|
/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:
|
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):
|
Date:
August 19, 2008
|
/s/ Michael G.
McGuinness
|
Michael
G. McGuinness
|
|
Chief
Operating and Financial
Officer
|
Dated:
August 19, 2008
|
/s/ Douglas
Abel
|
Douglas
Abel
|
|
President
and Chief Executive Officer
|
|
Dated:
August 19, 2008
|
/s/ Michael G.
McGuinness
|
Michael
G. McGuinness
|
|
Chief
Operating and Financial
Officer
|