|
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
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(State
or other jurisdiction of
|
(I.R.S.
Employer Identification No.)
|
incorporation
or organization)
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Page
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||
PART
I
|
FINANCIAL
INFORMATION
|
|
Item
1.
|
Financial
Statements:
|
|
Unaudited
Condensed Balance Sheets
|
4
|
|
Unaudited
Condensed Statements of Operations
|
5
|
|
Unaudited
Condensed Statement of Stockholders’ Equity (Deficiency)
|
6
|
|
Unaudited
Condensed Statements of Cash Flows
|
8
|
|
Notes
to Unaudited Condensed Financial Statements
|
10
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
23
|
Item
3.
|
Quantitative
and Qualitative Disclosure About Market Risk
|
36
|
Item
4T.
|
Controls
and Procedures
|
36
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1.
|
Legal
Proceedings
|
37
|
Item
1A.
|
Risk
Factors
|
37
|
Item
6.
|
Exhibits
|
37
|
Signatures
|
38
|
|
·
|
the
development of our product
candidates;
|
|
·
|
the
regulatory approval of our product
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.
|
September 30,
|
December 31,
|
|||||||
2009
|
2008
|
|||||||
(Unaudited)
|
(See Note 1)
|
|||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 153,641 | $ | 106,023 | ||||
Restricted
cash
|
- | 730,499 | ||||||
Other
current assets
|
86,609 | 37,718 | ||||||
Total
current assets
|
240,250 | 874,240 | ||||||
Investment
in Hedrin JV
|
162,952 | - | ||||||
Property
and equipment, net
|
4,775 | 9,072 | ||||||
Secured
12% notes payable issue costs
|
253,209 | 330,756 | ||||||
Other
assets
|
21,370 | 34,895 | ||||||
Total
assets
|
$ | 682,556 | $ | 1,248,963 | ||||
Liabilities
and Stockholders' Deficiency
|
||||||||
Current
Liabilities:
|
||||||||
Secured
10% notes payable
|
$ | - | $ | 70,000 | ||||
Accounts
payable
|
143,065 | 542,296 | ||||||
Accrued
expenses
|
774,320 | 874,072 | ||||||
Derivative
liability
|
681,111 | - | ||||||
Total
current liabilities
|
1,598,496 | 1,486,368 | ||||||
Secured
12% notes payable, net
|
1,607,610 | 1,174,107 | ||||||
Interest
payable on secured 12% notes payable
|
171,674 | 15,237 | ||||||
Exchange
obligation
|
3,949,176 | 2,949,176 | ||||||
Total
liabilities
|
7,326,956 | 5,624,888 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders’
deficiency:
|
||||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no
shares
|
||||||||
issued
and outstanding at September 30, 2009 and December 31,
2008
|
- | - | ||||||
Common
stock, $.001 par value. Authorized 300,000,000 shares;
|
||||||||
70,624,232
shares issued and outstanding at September 30, 2009
|
||||||||
and
December 31, 2008
|
70,624 | 70,624 | ||||||
Additional
paid-in capital
|
54,995,498 | 54,821,379 | ||||||
Deficit
accumulated during the development stage
|
(61,710,522 | ) | (59,267,928 | ) | ||||
Total
stockholders’ deficiency
|
(6,644,400 | ) | (4,375,925 | ) | ||||
Total
liabilities and stockholders' deficiency
|
$ | 682,556 | $ | 1,248,963 |
Three months ended
September 30,
|
Nine months ended
September 30,
|
Cumulative
period from
August 6, 2001
(inception) to
September 30,
|
||||||||||||||||||
2009
|
2008
|
2009
|
2008
|
2009
|
||||||||||||||||
Revenue
|
$ | - | $ | - | $ | - | $ | - | $ | - | ||||||||||
Costs
and expenses:
|
||||||||||||||||||||
Research
and development
|
5,574 | 498,853 | 57,154 | 1,864,652 | 28,348,989 | |||||||||||||||
General
and administrative
|
390,066 | 884,705 | 1,373,083 | 2,600,303 | 17,835,356 | |||||||||||||||
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
|
395,640 | 1,383,558 | 1,430,237 | 4,464,955 | 60,534,260 | |||||||||||||||
Operating
loss
|
(395,640 | ) | (1,383,558 | ) | (1,430,237 | ) | (4,464,955 | ) | (60,534,260 | ) | ||||||||||
Other
(income) expense:
|
||||||||||||||||||||
Equity
in losses of Hedrin JV
|
105,362 | 140,138 | 337,048 | 247,731 | 587,048 | |||||||||||||||
Change
in fair value of derivative
|
(157,778 | ) | - | 658,889 | - | 531,111 | ||||||||||||||
Interest
and other income
|
(63,873 | ) | (148,184 | ) | (252,500 | ) | (335,613 | ) | (1,533,031 | ) | ||||||||||
Interest
expense
|
136,738 | 18,804 | 396,698 | 18,804 | 487,522 | |||||||||||||||
Realized
gain on sale of marketable equity securities
|
- | - | - | - | (76,032 | ) | ||||||||||||||
Total
other (income) expense
|
20,449 | 10,758 | 1,140,135 | (69,078 | ) | (3,382 | ) | |||||||||||||
Net
loss
|
(416,089 | ) | (1,394,316 | ) | (2,570,372 | ) | (4,395,877 | ) | (60,530,878 | ) | ||||||||||
Preferred
stock dividends (including imputed amounts)
|
- | - | - | - | (1,179,644 | ) | ||||||||||||||
Net
loss applicable to common shares
|
$ | (416,089 | ) | $ | (1,394,316 | ) | $ | (2,570,372 | ) | $ | (4,395,877 | ) | $ | (61,710,522 | ) | |||||
Net
loss per common share:
|
||||||||||||||||||||
Basic
and diluted
|
$ | (0.01 | ) | $ | (0.02 | ) | $ | (0.04 | ) | $ | (0.06 | ) | ||||||||
Weighted
average shares of common stock outstanding:
|
||||||||||||||||||||
Basic
and diluted
|
70,624,232 | 70,624,232 | 70,624,232 | 70,624,232 |
Common
stock
shares
|
Common
stock
amount
|
Additional
paid-in
capital
|
Deficit
accumulated
during
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 | - | (282,363 | ) | (1,290 | ) | ||||||||||||||||
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 | ) | 297,334 | 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
|
- | - | 477,736 | - | (479,032 | ) | (1,296 | ) | ||||||||||||||||
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
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 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
|
- | - | 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
|
- | - | 271,075 | - | - | 271,075 | ||||||||||||||||||
Warrants
issued with secured 12% notes
|
- | - | 46,125 | - | - | 46,125 | ||||||||||||||||||
Warrant
issued to placement agent
|
- | - | 6,919 | - | - | 6,919 | ||||||||||||||||||
Net
loss
|
- | - | - | (2,570,372 | ) | - | (2,570,372 | ) | ||||||||||||||||
Balance
at September 30, 2009
|
70,624,232 | $ | 70,624 | $ | 54,995,498 | $ | (61,710,522 | ) | $ | - | $ | (6,644,400 | ) | |||||||||||
See
accompanying notes to financial statements.
|
Nine months ended September
30,
|
Cumulative period
from August 6,
2001 (inception) to
September 30,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (2,570,372 | ) | $ | (4,395,877 | ) | $ | (60,530,878 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Equity
in losses of Hedrin JV
|
337,048 | 247,731 | 587,048 | |||||||||
Share-based
compensation
|
271,075 | 379,060 | 4,099,948 | |||||||||
Amortization
of OID and issue costs on Secured 12% Notes
|
380,261 | - | 418,835 | |||||||||
Change
in fair value of derivative
|
658,889 | - | 531,111 | |||||||||
Shares
issued in connection with in-licensing agreement
|
- | - | 232,500 | |||||||||
Warrants
issued to consultant
|
- | - | 83,670 | |||||||||
Amortization
of intangible assets
|
- | - | 145,162 | |||||||||
Gain
on sale of marketable equity securities
|
- | - | (76,032 | ) | ||||||||
Depreciation
|
4,297 | 23,258 | 226,228 | |||||||||
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
|
- | 18,327 | 23,917 | |||||||||
Changes
in operating assets and liabilities, net of acquisitions:
|
- | - | ||||||||||
Decrease
in restricted cash
|
730,499 | - | - | |||||||||
Decrease/(increase)
in prepaid expenses and other current assets
|
(48,891 | ) | 140,430 | (28,364 | ) | |||||||
Decrease/(increase)
in other assets
|
13,525 | (9,119 | ) | (36,370 | ) | |||||||
Increase/(decrease)
in accounts payable
|
(399,231 | ) | (574,162 | ) | 563,278 | |||||||
Increase/(decrease)
in accrued expenses
|
(99,752 | ) | 646,126 | 233,999 | ||||||||
Net
cash used in operating activities
|
(722,652 | ) | (3,524,226 | ) | (39,342,217 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Purchase
of property and equipment
|
- | (8,972 | ) | (239,608 | ) | |||||||
Cash
paid in connection with acquisitions
|
- | - | (26,031 | ) | ||||||||
Net
cash provided from the purchase and sale of short-term
investments
|
- | - | 435,938 | |||||||||
Proceeds
from sale of license
|
- | - | 200,001 | |||||||||
Net
cash (used in) provided by investing activities
|
- | (8,972 | ) | 370,300 | ||||||||
Cash
flows from financing activities:
|
||||||||||||
Proceeds
from the Hedrin JV agreement
|
500,000 | 2,699,176 | 3,199,176 | |||||||||
Sale
of warrant
|
- | 150,000 | 150,000 | |||||||||
Proceeds
from sale of Secured 10% Notes
|
- | 70,000 | - | |||||||||
Repayment
of Secured 10% Notes
|
(70,000 | ) | - | - | ||||||||
Proceeds
from sale of Secured 12% Notes
|
340,270 | - | 1,345,413 | |||||||||
Repayments
of notes payable to stockholders
|
- | - | (884,902 | ) | ||||||||
Proceeds
related to sale of common stock, net
|
- | - | 25,896,262 | |||||||||
Proceeds
from sale of preferred stock, net
|
- | - | 9,046,176 | |||||||||
Proceeds
from exercise of warrants and stock options
|
- | - | 138,219 | |||||||||
Other,
net
|
- | - | 235,214 | |||||||||
Net
cash provided by financing activities
|
770,270 | 2,919,176 | 39,125,558 | |||||||||
Net
(decrease) increase in cash and cash equivalents
|
47,618 | (614,022 | ) | 153,641 | ||||||||
Cash
and cash equivalents at beginning of period
|
106,023 | 649,686 | - | |||||||||
Cash
and cash equivalents at end of period
|
$ | 153,641 | $ | 35,664 | $ | 153,641 |
Nine months ended September 30,
|
Cumulative
period from
August 6, 2001
(inception) to
September 30,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Supplemental
disclosure of cash flow information:
|
||||||||||||
Interest
paid
|
$ | - | $ | - | $ | 26,033 | ||||||
Supplemental
disclosure of noncash investing and financing activities:
|
||||||||||||
Investment
in Hedrin JV
|
$ | 500,000 | $ | 250,000 | $ | 750,000 | ||||||
Warrants
issued with Secured 12% Notes
|
53,044 | - | 223,172 | |||||||||
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 for acquisitions
|
- | - | 13,389,226 | |||||||||
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 |
3.
|
COMPUTATION
OF NET LOSS PER COMMON SHARE
|
4.
|
SHARE-BASED
COMPENSATION
|
Three months ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||
2009
|
2008
|
2009
|
2008
|
|||||||||||||
General
and administrative expense:
|
||||||||||||||||
Share-based
employee compensation cost
|
$ | 78,223 | $ | 64,071 | $ | 269,924 | $ | 279,476 | ||||||||
Share-based
consultant and non-employee cost
|
38 | - | 115 | - | ||||||||||||
78,261 | 64,071 | 270,039 | 279,476 | |||||||||||||
Research
and development expense:
|
||||||||||||||||
Share-based
employee compensation cost
|
- | 18,978 | - | 98,978 | ||||||||||||
Share-based
consultant and non-employee cost
|
344 | 347 | 1,036 | 606 | ||||||||||||
344 | 19,325 | 1,036 | 99,584 | |||||||||||||
Total
share-based cost
|
$ | 78,605 | $ | 83,396 | $ | 271,075 | $ | 379,060 |
Nine months ended
September 30,
|
||||||||
2009
|
2008
|
|||||||
Expected
volatility
|
94 | % | 92.3 | % | ||||
Dividend
yield
|
- | - | ||||||
Expected
term (in years)
|
6 | 6 | ||||||
Risk-free
interest rate
|
2.08 | 2.81 |
Shares
|
Weighted
average
exercise
price
|
Weighted
Average
Remaining
Contractual
Term (years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Outstanding
at December 31, 2008
|
10,633,836 | $ | 0.938 | |||||||||||||
Granted
|
- | |||||||||||||||
Exercised
|
- | |||||||||||||||
Canceled
|
3,007,234 | $ | 1.485 | |||||||||||||
Forfeited
|
166,666 | $ | 0.950 | |||||||||||||
Outstanding
at September 30, 2009
|
7,459,936 | $ | 0.718 | 6.410 | $ | - | ||||||||||
Exercisable
at September 30, 2009
|
6,734,110 | $ | 0.757 | 6.220 | $ | - | ||||||||||
Weighted-average
fair value of options granted during the nine month period ended September
30, 2009
|
None
issued
|
5.
|
COMMITMENTS
AND CONTINGENCIES
|
6.
|
JOINT
VENTURE
|
8.
|
SECURED
12% NOTES PAYABLE
|
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 12% Notes Transaction
|
35,714,287 | 7,142,857 | 42,857,144 | |||||||||
Antidilution
shares
|
19,841,269 | 3,968,254 | 23,809,523 | |||||||||
After
the 12% Notes Transaction
|
55,555,556 | 11,111,111 | 66,666,667 |
9.
|
LICENSE
AGREEMENTS
|
10.
|
DERIVATIVE
LIABILITY
|
11.
|
SUBSEQUENT
EVENTS
|
|
¨
|
After
the Ariston Merger, Manhattan would own 100% of the outstanding capital
stock of Ariston.
|
|
¨
|
As
consideration for the Ariston Merger, Manhattan would pay to the
holders of Ariston capital stock, in the aggregate, shares of
Manhattan common stock as follows:
|
|
o
|
at
the closing of the Ariston Merger, 7,062,423 shares of Manhattan
common stock (a number which represents 10% of the shares of Manhattan
common stock which were issued and outstanding as of September 10, 2009,
which was the date of the non-binding letter of intent);
and
|
|
o
|
the
right to receive additional contingent share consideration after
the closing as follows:
|
|
¨
|
7,062,423 additional
shares of Manhattan common stock upon acceptance by the US Food and
Drug Administration (“ FDA ”) of
Ariston’s filing of the first New Drug Application for Ariston's
AST-726 product candidate; and
|
|
¨
|
8,828,029 additional
shares of Manhattan common stock upon Ariston receiving FDA approval to
market Ariston's AST-726 product candidate in the United States;
and
|
|
¨
|
8,828,029 additional
shares of Manhattan common stock if there is demonstration of clinical
activity and safety with the AST-914 metabolite in the current National
Institutes of Health study in essential tremor patients resulting in a
decision by our Board of Directors, within 12 months following
the closing, to further develop the product internally or to seek a
corporate partnership based on the
program
|
|
¨
|
Ariston
would cause the holders of all outstanding Ariston convertible
promissory notes to convert their notes into convertible new
promissory notes to be issued by Ariston at the closing of the
Ariston Merger. The principal amount of the new notes
will be equal to the lesser of the principal amount of the currently
outstanding notes plus accrued and unpaid interest thereon through the
date of the closing of the Ariston Merger or $15.5
million. The new notes would have the following
terms:
|
|
o
|
interest
rate of 5% per annum compounding
annually;
|
|
o
|
interest
and principal are to be repaid from the net cash flow from AST-726 and AST
914 programs, 50% of this net cash flow will be used to repay the interest
and principal. (subject to adjustment if the notes include a conversion
feature and are converted.)
|
|
o
|
the
holders of the new notes will have no recourse to Manhattan or
any entity other than Ariston with respect to the payment of any amount
under the new notes or any indebtedness which had been converted
into new notes.
|
|
o
|
the new notes may
include a conversion feature such that the new notes would be
convertible at the option of the holder thereof into Manhattan common
stock at a conversion price currently anticipated to be $.40 per share
(the “ Conversion
Price ”) if a sufficient number of authorized common stock is
available.
|
Nine Months ended
September 30,
|
Increase
|
% Increase
|
||||||||||||||
2009
|
2008
|
(decrease)
|
(decrease)
|
|||||||||||||
Costs
and expenses:
|
||||||||||||||||
Research
and development:
|
||||||||||||||||
Share-based
compensation
|
$ | 1,000 | $ | 100,000 | $ | (99,000 | ) | -99.00 | % | |||||||
Other
research and development expenses
|
56,000 | 1,765,000 | (1,709,000 | ) | -96.83 | % | ||||||||||
Total
research and development expenses
|
57,000 | 1,865,000 | (1,808,000 | ) | -96.94 | % | ||||||||||
General
and administrative:
|
||||||||||||||||
Share-based
compensation
|
270,000 | 279,000 | (9,000 | ) | -3.23 | % | ||||||||||
Other
general and administrative expenses
|
1,103,000 | 2,321,000 | (1,218,000 | ) | -52.48 | % | ||||||||||
Total
general and administrative expenses
|
1,373,000 | 2,600,000 | (1,227,000 | ) | -47.19 | % | ||||||||||
Other
income/(expense)
|
||||||||||||||||
Equity
in lossess of Hedrin JV
|
(337,000 | ) | (248,000 | ) | (89,000 | ) | 35.89 | % | ||||||||
Change
in fair value of derivative
|
(659,000 | ) | - | (659,000 | ) | N/A | ||||||||||
Interest
expense
|
(397,000 | ) | (19,000 | ) | (378,000 | ) | N/A | |||||||||
Interest
and other income
|
253,000 | 336,000 | (83,000 | ) | -24.70 | % | ||||||||||
Total
other income/(expense)
|
(1,140,000 | ) | 69,000 | (1,209,000 | ) | -1752.17 | % | |||||||||
Net
loss
|
$ | 2,570,000 | $ | 4,396,000 | $ | (1,826,000 | ) | -41.54 | % |
Quarter ended September 30,
|
Increase
|
% Increase
|
||||||||||||||
2009
|
2008
|
(decrease)
|
(decrease)
|
|||||||||||||
Costs
and expenses:
|
||||||||||||||||
Research
and development:
|
||||||||||||||||
Share-based
compensation
|
$ | - | $ | 19,000 | $ | (19,000 | ) | -100.00 | % | |||||||
Other
research and development expenses
|
6,000 | 480,000 | (474,000 | ) | -98.75 | % | ||||||||||
Total
research and development expenses
|
6,000 | 499,000 | (493,000 | ) | -98.80 | % | ||||||||||
General
and administrative:
|
||||||||||||||||
Share-based
compensation
|
78,000 | 64,000 | 14,000 | 21.88 | % | |||||||||||
Other
general and administrative expenses
|
312,000 | 821,000 | (509,000 | ) | -62.00 | % | ||||||||||
Total
general and administrative expenses
|
390,000 | 885,000 | (495,000 | ) | -55.93 | % | ||||||||||
Other
income/(expense)
|
||||||||||||||||
Equity
in lossess of Hedrin JV
|
(105,000 | ) | (140,000 | ) | 35,000 | -25.00 | % | |||||||||
Change
in fair value of derivative
|
158,000 | - | 158,000 | N/A | ||||||||||||
Interest
expense
|
(137,000 | ) | (19,000 | ) | (118,000 | ) | N/A | |||||||||
Interest
and other income
|
64,000 | 148,000 | (84,000 | ) | -56.76 | % | ||||||||||
Total
other income/(expense)
|
(20,000 | ) | (11,000 | ) | 9,000 | -81.82 | % | |||||||||
Net
loss
|
$ | (416,000 | ) | $ | (1,395,000 | ) | $ | 979,000 | -70.18 | % |
¨
|
After
the Ariston Merger, Manhattan would own 100% of the outstanding capital
stock of Ariston.
|
¨
|
As
consideration for the Ariston Merger, Manhattan would pay to the
holders of Ariston capital stock, in the aggregate, shares of
Manhattan common stock as follows:
|
|||||
o
|
at
the closing of the Ariston Merger, 7,062,423 shares of Manhattan
common stock (a number which represents 10% of the shares of Manhattan
common stock which were issued and outstanding as of September 10, 2009,
which was the date of the non-binding letter of intent);
and
|
|||||
o
|
the
right to receive additional contingent share consideration after
the closing as follows:
|
|||||
¨
|
7,062,423 additional
shares of Manhattan common stock upon acceptance by the US Food and
Drug Administration (“ FDA
”) of Ariston’s filing of the first New Drug Application
for Ariston's AST-726 product candidate; and
|
|||||
¨
|
8,828,029 additional
shares of Manhattan common stock upon Ariston receiving FDA approval to
market Ariston's AST-726 product candidate in the United States;
and
|
|||||
¨
|
8,828,029 additional
shares of Manhattan common stock if there is demonstration of clinical
activity and safety with the AST-914 metabolite in the current National
Institutes of Health study in essential tremor patients resulting in a
decision by our Board of Directors, within 12 months following
the closing, to further develop the product internally or to seek a
corporate partnership based on the program
|
|||||
¨
|
Ariston
would cause the holders of all outstanding Ariston convertible
promissory notes to convert their notes into convertible new
promissory notes to be issued by Ariston at the closing of the
Ariston Merger. The principal amount of the new notes
will be equal to the lesser of the principal amount of the currently
outstanding notes plus accrued and unpaid interest thereon through the
date of the closing of the Ariston Merger or $15.5
million. The new notes would have the following
terms:
|
o
|
Interest
rate of 5% per annum compounding annually;
|
|
o
|
interest
and principal are to be repaid from the net cash flow from AST-726 and AST
914 programs, 50% of this net cash flow will be used to repay the interest
and principal. (subject to adjustment if the notes include a conversion
feature and are converted.)
|
|
o
|
the
holders of the new notes will have no recourse to Manhattan or
any entity other than Ariston with respect to the payment of any amount
under the new notes or any indebtedness which had been converted
into new notes.
|
|
o
|
the new notes may
include a conversion feature such that the new notes would be
convertible at the option of the holder thereof into Manhattan common
stock at a conversion price currently anticipated to be $.40 per share
(the “ Conversion
Price ”) if a sufficient number of authorized common stock is
available.
|
Exhibit No.
|
Description
|
|
31.1
|
Certification
of Principal Financial Officer
|
|
31.2
|
Certification
of Principal Executive Officer
|
|
32.1
|
Certification
of Principal Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of
2002.
|
MANHATTAN
PHARMACEUTICALS, INC.
|
||
Date:
November 16, 2009
|
By:
|
/s/ Michael G.
McGuinness
|
Michael
G. McGuinness
|
||
Chief
Operating and Financial
Officer
|
Exhibit
No.
|
Description
|
|
31.1
|
Certification
of Principal Executive Officer.
|
|
31.2
|
Certification
of Principal Financial Officer.
|
|
32.1
|
Certification
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) 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:
November 16, 2009
|
/s/ Michael G.
McGuinness
|
Michael
G. McGuinness
|
|
Principal
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:
November 16, 2009
|
/s/ Michael G.
McGuinness
|
Michael
G. McGuinness
|
|
Chief
Financial Officer
|
Dated:
November 16, 2009
|
/s/ Michael G.
McGuinness
|
Michael
G. McGuinness
|
|
Principal
Executive Officer and Chief Financial
Officer
|