TG THERAPEUTICS, INC. - Quarter Report: 2007 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
[X] |
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the
quarterly period ended March 31, 2007
OR
[ ] |
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the
transition period from _______ to _______
Commission
file number 001-32639
Manhattan
Pharmaceuticals, Inc.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
(State
or other jurisdiction of
incorporation
or organization)
|
36-3898269
(I.R.S.
Employer Identification No.)
|
810
Seventh Avenue, 4th Floor, New York, New York 10019
(Address
of principal executive offices)
(212)
582-3950
(Issuer’s
telephone number)
Check
whether the issuer: (1) filed all reports required to be filed by Section 13
or
15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or
for such shorter period that the issuer was required to file such reports),
and
(2) has been subject to such filing requirements for the past 90 days. Yes
[X]
No [ ]
Indicate
by check mark whether the registrant is a large accelerated filer, accelerated
filer, or a non-accelerated filer. See definition of “accelerated filer and
large accelerated filer” in Rule 12b-2 of the Exchange Act (check one):
Large
accelerated filer
o
Accelerated filer
o
Non-accelerated filer
x
Indicate
by check mark whether the registrant is a shell company (as defined by Rule
12b-2 of the Exchange Act). Yes [ ] No [X]
As
of May
2, 2007 there were 70,470,419 shares of the issuer’s common stock, $.001 par
value, outstanding.
1
INDEX
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
|
16
|
Item
3.
|
Quantitative
and Qualitative Disclosure About Market Risk
|
24
|
Item
4.
|
Controls
and Procedures
|
24
|
PART
II
|
OTHER
INFORMATION
|
|
Item
5.
|
Other
Events
|
25
|
Item
6.
|
Exhibits
|
25
|
Signatures
|
26
|
2
Forward-Looking
Statements
This
quarterly report on Form 10-Q contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, or the
Securities Act, and Section 21E of the Exchange Act. Any statements about
our expectations, beliefs, plans, objectives, assumptions or future events
or
performance are not historical facts and may be forward-looking. These
statements are often, but not always, made through the use of words or phrases
such as “anticipate,” “estimate,” “plan,” “project,” “expect,” “may,” “intend”
and similar words or phrases. Accordingly, these statements involve estimates,
assumptions and uncertainties that could cause actual results to differ
materially from those expressed in them. These statements are therefore subject
to risks and uncertainties, known and unknown, which could cause actual results
and developments to differ materially from those expressed or implied in such
statements. Such risks and uncertainties relate to, among other
factors:
· |
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.
|
Further,
any forward-looking statement speaks only as of the date on which it is made,
and we undertake no obligation to update any forward-looking statement or
statements to reflect events or circumstances after the date on which such
statement is made or to reflect the occurrence of unanticipated events. New
factors emerge from time to time, and it is not possible for us to predict
which
factors will arise. In addition, we cannot assess the impact of each factor
on
our business or the extent to which any factor, or combination of factors,
may
cause actual results to differ materially from those contained in any
forward-looking statements.
3
PART
I - FINANCIAL INFORMATION
Item
1. Unaudited Condensed Consolidated Financial
Statements
MANHATTAN
PHARMACEUTICALS, INC. AND
SUBSIDIARIES
|
||||||||||
(A
Development Stage Company)
|
||||||||||
Condensed
Consolidated Balance Sheets
|
||||||||||
March
31,
|
December
31,
|
|||||||||
Assets
|
2007
|
2006
|
||||||||
(Unaudited)
|
(See
Note 1)
|
|||||||||
Current
assets:
|
||||||||||
Cash
and cash equivalents
|
$
|
8,689,792
|
$
|
3,029,118
|
||||||
Subscription
receivable
|
250,000
|
—
|
||||||||
Prepaid
expenses
|
252,092
|
264,586
|
||||||||
Total
current assets
|
9,191,884
|
3,293,704
|
||||||||
Property
and equipment, net
|
74,132
|
83,743
|
||||||||
Other
assets
|
70,506
|
70,506
|
||||||||
Total
assets
|
$
|
9,336,522
|
$
|
3,447,953
|
||||||
Liabilities
and Stockholders’
Equity
|
||||||||||
Current
liabilities:
|
||||||||||
Accounts
payable
|
$
|
1,523,663
|
$
|
1,393,296
|
||||||
Accrued
expenses
|
669,247
|
550,029
|
||||||||
Total
liabilities
|
2,192,910
|
1,943,325
|
||||||||
Commitments
and contingencies
|
||||||||||
Stockholders’
equity:
|
||||||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares;
|
||||||||||
no
shares issued and outstanidng at March 31, 2007
|
||||||||||
and
December 31, 2006, respectively
|
— | — | ||||||||
Common
stock, $.001 par value. Authorized 150,000,000 shares;
|
||||||||||
70,333,316
and 60,120,038 shares issued and outstanding
|
||||||||||
at
March 31, 2007 and December 31, 2006, respectively
|
70,334
|
60,120
|
||||||||
Additional
paid-in capital
|
52,604,353
|
44,411,326
|
||||||||
Deficit
accumulated during the development stage
|
(45,531,075
|
)
|
(42,966,818
|
)
|
||||||
Total
stockholders’ equity
|
7,143,612
|
1,504,628
|
||||||||
Total
liabilities and stockholders' equity
|
$
|
9,336,522
|
$
|
3,447,953
|
||||||
See
accompanying notes to unaudited condensed consolidated financial
statements.
|
4
MANHATTAN PHARMACEUTICALS, INC. AND SUBSIDIARIES
|
||||||||||
(A Development Stage Company)
|
||||||||||
Condensed Consolidated Statements of Operations
|
||||||||||
(Unaudited)
|
Cumulative
| ||||||||||
period from
| ||||||||||
August 6, 2001
| ||||||||||
(inception) to
| ||||||||||
Three months ended March 31,
| March 31,
| |||||||||
2007
| 2006
| 2007
|
Revenue
| $
| —
| $
| —
| $
| —
| ||||
Costs and expenses:
| ||||||||||
Research and development
| ||||||||||
(including stock based compensation expense of
| ||||||||||
$102,739, $98,302 and $631,462 for the three months
| ||||||||||
ended March 31, 2007, March 31, 2006 and for the
| ||||||||||
cumulative period from August 6, 2001 (inception) to
| ||||||||||
March 31, 2007, respectively)
| 1,679,448
| 1,686,441
| 19,632,804
| |||||||
General and administrative
| ||||||||||
(including stock based compensation expense of
| ||||||||||
$232,471, $213,610 and $1,379,247 for the three months
| ||||||||||
ended March 31, 2007, March 31, 2006 and for the
| ||||||||||
cumulative period from August 6, 2001 (inception) to
| ||||||||||
March 31, 2007, respectively)
| 914,724
| 810,945
| 11,158,817
| |||||||
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
| 2,594,172
| 2,497,386
| 45,141,536
| |||||||
Operating loss
| (2,594,172)
| (2,497,386)
| (45,141,536)
| |||||||
Other (income) expense:
| ||||||||||
Interest and other income
| (30,390)
| (98,7060)
| (740,106)
| |||||||
Interest expense
| 475
| —
| 26,033
| |||||||
Realized gain on sale of marketable equity securities
| —
| (490)
| (76,032)
| |||||||
Total other income
| (29,915)
| (99,196)
| (790,105)
| |||||||
Net loss
| (2,564,257)
| (2,398,190)
| (44,351,431)
| |||||||
Preferred stock dividends (including imputed amounts)
| —
| —
| (1,179,644)
| |||||||
Net loss applicable to common shares
| $
| (2,564,257)
| $
| (2,398,190)
| $
| (45,531,075)
| ||||
Net loss per common share:
| ||||||||||
Basic and diluted
| $
| (0.04)
| $
| (0.04)
| ||||||
Weighted average shares of common stock outstanding:
| ||||||||||
Basic and diluted
| 60,235,679
| 60,092,697
| ||||||||
See accompanying notes to unaudited condensed consolidated financial statements.
|
5
MANHATTAN
PHARMACEUTICALS, INC. AND
SUBSIDIARIES
|
||||||||||||||||||||||||||||||||||
(A
Development Stage
Company)
|
||||||||||||||||||||||||||||||||||
Condensed
Consolidated Statement of
Stockholders' Equity (Deficiency)
|
||||||||||||||||||||||||||||||||||
(Unaudited)
|
||||||||||||||||||||||||||||||||||
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
|
7,837,845
|
—
|
—
|
—
|
—
|
—
|
7,848,031
|
|||||||||||||||||||||||
Common
stock issued to directors at $0.72 per share in
|
||||||||||||||||||||||||||||||||||
satisfaction
of accounts payable
|
—
|
—
|
27,776
|
28
|
19,972
|
—
|
—
|
—
|
—
|
20,000
|
||||||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
335,210
|
—
|
—
|
—
|
—
|
—
|
335,210
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
-
|
—
|
(2,564,257
|
)
|
—
|
—
|
—
|
(2,564,257
|
)
|
|||||||||||||||||||||
Balance
at March 31, 2007
|
—
|
$
|
—
|
70,333,316
|
$
|
70,334
|
$
|
52,604,353
|
$
|
—
|
$
|
(45,531,075
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
7,143,612
|
|||||||||||||
|
See
accompanying notes to unaudited condensed consolidated financial
statements.
|
6
MANHATTAN
PHARMACEUTICALS, INC. AND
SUBSIDIARIES
|
|||||||||||||
(A
Development Stage Company)
|
|||||||||||||
Condensed
Consolidated Statements of Cash Flows
|
|||||||||||||
(Unaudited)
|
|||||||||||||
Cumulative
|
|||||||||||||
period
from
|
|||||||||||||
August
6, 2001
|
|||||||||||||
(inception)
to
|
|||||||||||||
Three
months ended March 31,
|
March
31,
|
||||||||||||
2007
|
2006
|
2007
|
|||||||||||
Cash
flows from operating activities:
|
|||||||||||||
Net
loss
|
$
|
(2,564,257
|
)
|
$
|
(2,398,190
|
)
|
$
|
(44,351,431
|
)
|
||||
Adjustments
to reconcile net loss to
|
|||||||||||||
net
cash used in operating activities:
|
|||||||||||||
Share-based
compensation
|
335,210
|
311,912
|
2,259,237
|
||||||||||
Amortization
of intangible assets
|
—
|
—
|
145,162
|
||||||||||
Gain
on sale of marketable equity securities
|
—
|
(490
|
)
|
(76,032
|
)
|
||||||||
Depreciation
|
15,878
|
14,853
|
163,358
|
||||||||||
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
|
12,494
|
(284,511
|
)
|
(193,847
|
)
|
||||||||
Increase
in subscription receivable
|
(250,000
|
)
|
(250,000
|
)
|
|||||||||
Increase
in other assets
|
—
|
—
|
(70,506
|
)
|
|||||||||
Increase
in accounts payable
|
150,367
|
373,548
|
1,943,877
|
||||||||||
Increase
in accrued expenses
|
119,218
|
207,581
|
128,926
|
||||||||||
Net
cash used in operating activities
|
(2,181,090
|
)
|
(1,775,297
|
)
|
(26,111,935
|
)
|
|||||||
Cash
flows from investing activities:
|
|||||||||||||
Purchase
of property and equipment
|
(6,267
|
)
|
(8,499
|
)
|
(227,768
|
)
|
|||||||
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
|
(6,267
|
)
|
491,501
|
382,140
|
|||||||||
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
|
7,848,031
|
(10,166
|
)
|
25,892,108
|
|||||||||
Proceeds
from sale of preferred stock, net
|
—
|
—
|
9,046,176
|
||||||||||
Proceeds
from exercise of warrants and stock options
|
—
|
—
|
130,991
|
||||||||||
Other,
net
|
—
|
—
|
237,500
|
||||||||||
Net
cash (used in) provided by financing activities
|
7,848,031
|
(10,166
|
)
|
34,419,587
|
|||||||||
Net
(decrease) increase in cash and cash equivalents
|
5,660,674
|
(1,293,962
|
)
|
8,689,792
|
|||||||||
Cash
and cash equivalents at beginning of period
|
3,029,118
|
9,826,336
|
—
|
||||||||||
Cash
and cash equivalents at end of period
|
$
|
8,689,792
|
$
|
8,532,374
|
$
|
8,689,792
|
|||||||
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 ccounts 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
|
||||||||||
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
|
—
|
—
|
27
|
||||||||||
See
accompanying notes to unaudited condensed consolidated financial
statements.
|
7
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(1) SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements of Manhattan
Pharmaceuticals, Inc. and its subsidiaries (“Manhattan” or the “Company”) have
been prepared in accordance with accounting principles generally accepted in
the
United States of America for interim financial information and the rules and
regulations of the Securities and Exchange Commission. Accordingly, the
unaudited condensed consolidated financial statements do not include all
information and footnotes required by accounting principles generally accepted
in the United States of America for complete annual financial statements. In
the
opinion of management, the accompanying unaudited condensed consolidated
financial statements reflect all adjustments, consisting of only normal
recurring adjustments, considered necessary for a fair presentation. Interim
operating results are not necessarily indicative of results that may be expected
for the year ending December 31, 2007 or for any other interim period.
These unaudited condensed consolidated financial statements should be read
in
conjunction with the Company’s audited consolidated financial statements as of
and for the year ended December 31, 2006, which are included in the
Company’s Annual Report on Form 10-KSB for such year. The condensed balance
sheet as of December 31, 2006 has been derived from the audited financial
statements included in the Form 10-KSB for that year.
As
of
December 31, 2006 all of the Company’s subsidiaries had either been dissolved or
merged into Manhattan. As a result, the Company had no subsidiaries during
the
three month period ended March 31, 2007.
Reclassifications
Certain
reclassifications have been made to prior-year amounts to conform to the
current-year presentations.
Segment
Reporting
The
Company has determined that it operates in only one segment currently, which
is
biopharmaceutical research and development.
Income
Taxes
Effective
January1, 2007, the Company adopted the provisions of Financial Accounting
Standards Board (“FASB”) Interpretation No. 48 (“FIN 48”), Accounting
for Uncertainty in Income Taxes - an interpretation of FASB No.
109.
The
implementation of FIN 48 had no impact on the Company’s financial statements as
the Company has no unrecognized tax benefits.
The
Company’s policy is to recognize interest and penalties related to income tax
matters in income tax expense. As of January 1 and March 31, 2007, the Company
had no accruals for interest or penalties related to income taxes.
8
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
(2) LIQUIDITY
The
Company incurred a net loss of $2,564,257 and negative cash flows from operating
activities of $2,181,090 for the three months ended March 31, 2007. The net
loss
from date of inception, August 6, 2001 to March 31, 2007 amounts to
$44,351,431.
Management
believes that the Company will continue to incur net losses through at least
March 31, 2008 and for the foreseeable future thereafter. Based on the resources
of the Company available at March 31, 2007, management believes that the Company
will need additional equity or debt financing or will need to generate revenues
through licensing of its products or entering into strategic alliances to be
able to sustain its operations into 2008. Furthermore, we will need additional
financing thereafter to complete development and commercialization of our
product candidates.
The
Company’s continued operations will depend on its ability to raise additional
funds through various potential sources such as equity and debt financing,
collaborative agreements, strategic alliances and its ability to realize the
full potential of its technology in development. Additional funds may not become
available on acceptable terms, and there can be no assurance that any additional
funding that the Company does obtain will be sufficient to meet the Company’s
needs in the long-term.
(3) COMPUTATION
OF NET LOSS PER COMMON SHARE
Basic
net
loss per common share is calculated by dividing net loss applicable to common
shares by the weighted-average number of common shares outstanding for the
period. Diluted net loss per common share is the same as basic net loss per
common share, since potentially dilutive securities from the assumed exercise
of
stock options and stock warrants would have an antidilutive effect because
the
Company incurred a net loss during each period presented. The amounts of
potentially dilutive securities excluded from the calculation of diluted net
loss per share were 17,886,567 and 13,782,396 as of March 31, 2007 and 2006,
respectively.
(4) SHARE-BASED
COMPENSATION
Effective
January 1, 2006, the Company adopted Statement of Financial Accounting Standards
No. 123(R), “Share-Based Payment,” (“Statement 123(R)”) for employee options
using the modified prospective transition method. Statement 123(R) revised
Statement 123 “Accounting for Stock-based Compensation” to eliminate the option
to use the intrinsic value method and required the Company to expense the fair
value of all employee options over the vesting period. Under the modified
prospective transition method, the Company recognized compensation cost for
the
three month periods ending March 31, 2007 and 2006 based on the grant date
fair
value estimated in accordance with Statement 123(R). This includes a) period
compensation cost related to share-based payments granted prior to, but not
yet
vested, as of January 1, 2006, based on the grant date fair value estimated
in
accordance with the original provisions of Statement 123; and b) period
compensation cost related to share-based payments granted on or after January
1,
2006. In accordance with the modified prospective method, the Company has not
restated prior period results.
9
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
The
Company recognized compensation expense related to stock option grants on a
straight-line basis over the vesting period. For the three month periods ended
March 31, 2007 and 2006, the Company recognized share-based employee
compensation cost of $335,210 and $311,912, respectively, in accordance with
Statement 123(R). $270,451 and $285,745, respectively, of this expense resulted
from the grants of stock options to employees, officers and directors of the
Company on or prior to December 31, 2005. The balances of $64,759 and $26,167,
respectively, relate to the granting of stock options to employees and officers
on or after January 1, 2006. The Company did not capitalize any share-based
compensation cost.
Options
granted to consultants and other non-employees are accounted for in accordance
with Emerging Issues Task Force (“EITF”) No. 96-18 "Accounting for Equity
Instruments That Are Issued to Other than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services", and Financial Accounting Standards
Board Interpretation No 28 “Accounting for Stock Appreciation Rights and Other
Variable Option or Award Plans”. Accordingly, such options are recorded at
fair value at the date of grant and subsequently adjusted to fair value at
the end of each reporting period until such options vest, and the fair
value of the options, as adjusted, is amortized to consulting expense over
the related vesting period. As a result of adjusting consultant and other
non-employee options to fair value as of March 31, 2007 and 2006, net of
amortization, the Company recognized general and administrative and research
and
development expenses of $3,371 for the three-months ended March 31, 2007 and
$23,971 for the three-months ended March 31, 2006.
The
Company has allocated share-based compensation costs to general and
administrative and research and development expenses as follows:
|
Three
months ended
|
Three
months ended
|
||||||||
March
31, 2007
|
March
31, 2006
|
|||||||||
General
and administrative expense:
|
||||||||||
Share-based
employee compensation cost
|
$
|
221,921
|
$
|
208,021
|
||||||
Share-based
consultant and non-employee cost
|
10,550
|
5,589
|
||||||||
$
|
232,471
|
$
|
213,610
|
|||||||
Research
and development expense
|
||||||||||
Share-based
employee compensation cost
|
$
|
109,918
|
$
|
79,920
|
||||||
Share-based
consultant and non-employee (credit) cost
|
(7,179
|
)
|
18,382
|
|||||||
$
|
102,739
|
$
|
98,302
|
|||||||
Total
share-based cost
|
$
|
335,210
|
$
|
311,912
|
||||||
10
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
The
Company has shareholder-approved stock incentive plans for employees under
which
it has granted non-qualified and incentive stock options. In December 2003,
the
Company established the 2003 Stock Option Plan (the “2003 Plan”), which provided
for the granting of up to 5,400,000 options to officers, directors, employees
and consultants for the purchase of stock. In August 2005, the Company increased
the number of shares of common stock reserved for issuance under the 2003 Plan
by 2,000,000 shares. At March 31, 2007, 7,400,000 shares were authorized for
issuance. Under the 2003 Plan at March 31, 2007 options to purchase 6,292,430
shares were outstanding and 27,776 shares of common stock have been issued
leaving a total of 1,079,794 shares reserved for future stock option grants.
The
options have a maximum term of 10 years and vest over a period determined by
the
Company’s Board of Directors (generally 3 years) and are issued at an exercise
price equal to or greater than the fair market value of the shares at the date
of grant. The 2003 Plan expires on December 10, 2013 or when all options have
been granted, whichever is sooner. Under
the
2003 Plan, the Company granted options to purchase an aggregate of 472,500
shares of common stock during the three months ended March 31, 2007 of which
options to purchase 300,000 and 97,500 shares of common stock were granted
at an
exercise price of $0.72 to directors and employees, respectively, and options
to
purchase 75,000 shares of common stock were granted to an employee at an
exercise price of $0.82. Additionally, on January 30, 2007, the Company’s
non-employee directors agreed to accept an aggregate of 27,776 shares of the
Company’s common stock, each valued at $0.72 per share (the closing sale price
of the common stock on such date), in lieu of receiving $20,000 in aggregate
cash fees owed to such directors for their services in 2006. Such shares were
issued pursuant to the 2003 plan.
In
July
1995, the Company established the 1995 Stock Option Plan (the”1995 Plan”), which
provided for the granting of options to purchase up to 130,000 shares of the
Company’s common stock to officers, directors, employees and consultants. The
1995 Plan was amended several times to increase the number shares reserved
for
stock option grants. In June 2005, the 1995 Plan expired and no further options
can be granted. As of March 31, 2007, options to purchase 1,137,240 shares
were
outstanding under the 1995 Plan and no shares were reserved for future stock
option grants.
To
compute compensation expense in 2007 and 2006, the Company estimated the fair
value of each option award on the date of grant using the Black-Scholes model.
The Company based the expected volatility assumption on a volatility index
of
peer companies as the Company did not have a sufficient number of years of
historical volatility of its common stock for the application of Statement
123(R). The expected term of options granted represents the period of time
that
options are expected to be outstanding. The Company estimated the expected
term
of stock options by the simplified method as prescribed in The Securities and
Exchange Commission’s Staff Accounting Bulletin No. 107. The expected forfeiture
rates are based on the historical forfeiture experiences. To determine the
risk-free interest rate, the Company utilized the U.S. Treasury yield curve
in
effect at the time of grant with a term consistent with the expected term of
the
Company’s awards. The Company has not declared a dividend on its common stock
since its inception and has no intentions of declaring a dividend in the
foreseeable future and therefore used a dividend yield of zero.
11
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
The
following table shows the weighted average assumptions the Company used to
develop the fair value estimates for the determination of the compensation
charges in 2007 and 2006:
Three
months ended
|
Three
Months Ended
|
|||||||
March
31, 2007
|
March
31, 2006
|
|||||||
Expected
Volatility
|
80.2%
- 81.7%
|
55%
|
||||||
Dividend
yield
|
—
|
—
|
||||||
Expected
term (in years)
|
6
-
10
|
6
-
10
|
||||||
Risk-free
interest rate
|
4.56%
- 4.86%
|
4.25%
|
A
summary
of the status of the Company’s stock outstanding options as of March 31, 2007
and changes during the three months then ended is presented below:
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
|
472,500
|
0.83
|
|||||||||||
Exercised
|
-
|
-
|
|||||||||||
Cancelled
|
(43,334
|
)
|
1.18
|
||||||||||
Outstanding
at March 31, 2007
|
7,429,670
|
$
|
1.28
|
7.54 |
$
|
560,285
|
|||||||
Options
exercisable at
|
|||||||||||||
March
31,
2007
|
5,085,879
|
$
|
1.30
|
7.17
|
$
|
438,235
|
|||||||
Weighted-average
|
|||||||||||||
fair
value of
options
|
|||||||||||||
granted
during
the
|
|||||||||||||
three
months
ended
|
|||||||||||||
March
31,
2007
|
$
|
0.53
|
|||||||||||
12
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
As
of
March 31, 2007, the total compensation cost related to non-vested option awards
not yet recognized is $1,235,880. The weighted average period over which it
is
expected to be recognized is approximately 1.1 years.
In
November 2005, the FASB issued FASB Staff Position No. FAS 123(R)-3 (“FSP
123(R)-3”), “Transition Election Related to Accounting for the Tax Effects of
Share-Based Payment Awards”. The Company has adopted this alternative
transition method provided in FSP 123(R)-3 for calculating the tax effects
of
stock-based compensation pursuant to SFAS 123(R) in 2006. The alternative
transition method includes simplified methods to establish the beginning balance
of the additional paid-in capital pool (APIC pool) related to the tax effects
of
employee stock-based compensation, and to determine the subsequent impact on
the
APIC pool and consolidated statements of cash flows of the tax effects of
employee stock-based compensation awards that are outstanding upon adoption
of
SFAS 123(R). The adoption did not have a material impact on our results of
operations and financial condition.
(5) COMMITMENTS
The
Company often contracts with third parties to facilitate, coordinate and perform
agreed upon research and development of its product candidates. To ensure that
research and development costs are expensed as incurred, the Company records
monthly accruals for clinical trials and preclinical testing costs based on
the
work performed under the contracts.
These
contracts typically call for the payment of fees for services at the initiation
of the contract and/or upon the achievement of certain milestones. This method
of payment often does not match the related expense recognition resulting in
either a prepayment, when the amounts paid are greater than the related research
and development costs expensed, or an accrued liability, when the amounts paid
are less than the related research and development costs expensed.
On
March
27, 2006, the Company entered into a research and development agreement with
Swiss Pharma Contract Ltd. (“Swiss Pharma”) to perform a Phase IIa study in 100
obese patients of the Company’s Oleoyl-estrone product candidate being developed
for the treatment of obesity. The terms of the contract call for the Company
to
pay Swiss Pharma up to $2,151,840.
In
the
fourth quarter of 2006, the Company expanded its ongoing Phase IIa clinical
trial of Oleoyle-estrone in obesity into two new clinical sites in the United
States. Because the size of the study has not been expanded beyond the 100
obese
patients, the Company does not anticipate the additional sites will materially
increase its total financial commitment of up to $2,151,840. Such financial
commitment will now be paid to three clinical centers rather than one. This
Phase IIa clinical trial is expected to conclude in the second quarter of
2007.
At
March
31, 2007, the Company recognized a total expense of $1,676,408 and expects
the
balance of the financial commitment of approximately $500,000 to be incurred
through the conclusion of the trial.
13
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
In
the
fourth quarter of 2006, the Company commenced a Phase IIa clinical trial of
its
product candidate Oleoyl-estrone in the morbidly obese at St. Lukes/Roosevelt
Hospital in New York City. The financial commitment for this study is
approximately $685,000.
In
the
first quarter of 2007, the Company expanded its ongoing Phase IIa clinical
trial
in the morbidly obese into two new clinical sites, also in the United States.
The scope and financial commitment of this study remains unchanged. The study
is
expected to conclude in the first half of 2007.
At
March
31, 2007, the Company recognized expense of $119,302 for the study and expects
the balance of the financial commitment of approximately $566,000 to be incurred
through the conclusion of the trial.
(6) PRIVATE
PLACEMENT OF COMMON SHARES
On
March
30, 2007, the Company entered into a series of subscription agreements with
various institutional and other accredited investors for the issuance and sale
in a private placement of an aggregate of 10,185,502 shares of its common stock
for total net proceeds of approximately $7.85 million, after deducting
commissions and other costs of the transaction. Of the total amount of shares
issued, 10,129,947 were sold at a per share price of $0.84, and an additional
55,555 shares were sold to an entity affiliated with a director of the Company,
at a per share price of $0.90, the closing sale price of the common stock on
March 29, 2007. Pursuant to the subscription agreements, the Company also issued
to the investors 5-year warrants to purchase an aggregate of 3,564,897 shares
of
common stock at an exercise price of $1.00 per share. The warrants are
exercisable during the period commencing September 30, 2007 and ending March
30,
2012. The private placement was completed on March 30, 2007, however, a portion
of the proceeds was received subsequent to March 31, 2007, resulting in a
$250,000 subscription receivable at March 31, 2007.
Pursuant
to these subscription agreements the Company agreed to file a registration
statement covering the resale of the shares issued in the private placement,
including the shares issuable upon exercise of the investor warrants and the
placement agent warrants, with the Securities and Exchange Commission on or
before May 14, 2007 and use its reasonable best efforts to have such
registration statement declared effective by the Securities and Exchange
Commission on or before July 28, 2007. In the event the Company has not filed
such registration statement on or before May 14, 2007 or if the registration
statement has not been declared effective on or before July 28, 2007, then
in
either case the Company shall make compensatory payments to the investors in
an
amount equal to one percent (1%) of the aggregate purchase price paid by the
investors for each monthly period (or prorated portion thereof) in which the
Company is in default of either of these obligations. In
no
event shall the amount of compensatory payments payable by the Company exceed
ten percent (10%) of the aggregate purchase price paid by the
investors.
The
Company filed the registration statement of May 9, 2007.
The
Company engaged Paramount BioCapital, Inc., an affiliate of a significant
stockholder of the Company, as its placement agent in connection with the
private placement. In consideration for its services, the Company paid aggregate
cash commissions of approximately $600,000 and issued to Paramount a 5-year
warrant to purchase an aggregate of 509,275 shares at an exercise price of
$1.00
per share.
14
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
(7) SUBSEQUENT
EVENTS
a)
Altoderm
License Agreement
On
April
3, 2007, the Company entered into a license agreement for “Altoderm” (the
“Altoderm Agreement”) with Thornton & Ross LTD (“T&R”). Pursuant to the
Altoderm Agreement, the Company acquired an exclusive North American license
to
certain patent rights and other intellectual property relating to Altoderm,
a
topical skin lotion product candidate using sodium cromoglicate for the
treatment of atopic dermatitis. In accordance with the terms of the Altoderm
Agreement, the Company issued 125,000 shares of its common stock, valued at
$112,500, and made a cash payment of $475,000 to T&R upon the execution of
the agreement. Further, the Company agreed to make future milestone payments
to
T&R comprised of various combinations of cash and common stock in respective
aggregate amounts of $5,675,000 and 875,000 shares of common stock upon the
achievement of various clinical and regulatory milestones. The Company also
agreed to pay royalties on net sales of products using the licensed patent
rights at rates ranging from 10% to 20%, depending on the level of annual net
sales, and subject to an annual minimum royalty payment of $1 million in each
year following the first commercial sale of Altoderm. The Company may sublicense
the patent rights. The Company agreed to pay T&R 30% the royalties received
by the Company under such sublicense agreements.
b)
Altolyn
License Agreement
On
April
3, 2007, the Company and T&R also entered into a license agreement for
“Altolyn” (the “Altolyn Agreement”). Pursuant to the Altolyn Agreement, the
Company acquired an exclusive North American license to certain patent rights
and other intellectual property relating to Altolyn, an oral formulation product
candidate using sodium cromoglicate for the treatment of mastocytosis, food
allergies, and inflammatory bowel disorder. In accordance with the terms of
the
Altolyn Agreement, the Company made a cash payment of $475,000 to T&R upon
the execution of the agreement. Further, the Company agreed to make future
cash
milestone payments to T&R in an aggregate amount of $5,675,000 upon the
achievement of various clinical and regulatory milestones. The Company also
agreed to pay royalties on net sales of products using the licensed patent
rights at rates ranging from 10% to 20%, depending on the level of annual net
sales, and subject to an annual minimum royalty payment of $1 million in each
year following the first commercial sale of Altolyn. The Company may sublicense
the patent rights. The Company agreed to pay T&R 30% the royalties received
by the Company under such sublicense agreements.
15
Item
2. Management’s
Discussion and Analysis Financial Condition and Results
of Operations
You
should read the following discussion of our results of operations and financial
condition in conjunction with our Annual Report on Form 10-KSB for the year
ended December 31, 2006 (the “Annual Report”) and our financial statements
as of and for the three months ended March 31, 2007 included elsewhere in this
report.
We
were
incorporated in Delaware in 1993 under the name “Atlantic Pharmaceuticals, Inc.”
and, in March 2000, we changed our name to “Atlantic Technology Ventures, Inc.”
In 2003, we completed a “reverse acquisition” of privately held “Manhattan
Research Development, Inc. In connection with this transaction, we also changed
our name to “Manhattan Pharmaceuticals, Inc.” From an accounting perspective,
the accounting acquirer is considered to be Manhattan Research Development,
Inc.
and accordingly, the historical financial statements are those of Manhattan
Research Development, Inc.
During
2005 we merged with Tarpan Therapeutics, Inc. (“Tarpan”). Tarpan was a privately
held New York based biopharmaceutical company developing dermatological
therapeutics. Through the merger, we acquired Tarpan’s primary product
candidate, topical PTH (1-34) for the treatment of psoriasis. In consideration
for their shares of Tarpan’s capital stock, the stockholders of Tarpan received
an aggregate of approximately 10,731,000 shares of our common stock,
representing approximately 20% of our then outstanding common shares. This
transaction was accounted for as a purchase of Tarpan by the
Company.
We
are a
development stage biopharmaceutical company focused on developing and
commercializing innovative pharmaceutical therapies for underserved patient
populations. We aim to acquire rights to these technologies by licensing or
otherwise acquiring an ownership interest, funding their research and
development and eventually either bringing the technologies to market or
out-licensing. We currently have five product candidates in
development:
· |
Oleoyl-estrone,
an orally administered small molecule for the treatment of
obesity;
|
· |
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
Lingual Spray Propofol for sedation prior to diagnostic, therapeutic
or
endoscopic procedures.
|
We
have
not received regulatory approval for, or generated commercial revenues from
marketing or selling any drugs.
You
should read the following discussion of our results of operations and financial
condition in conjunction with the consolidated financial statements and notes
thereto appearing elsewhere in this Quarterly report on Form 10-Q. This
discussion includes “forward-looking” statements that reflect our current views
with respect to future events and financial performance. We use words such
as we
“expect,” “anticipate,” “believe,” and “intend” and similar expressions to
identify forward-looking statements. Investors should be aware that actual
results may differ materially from our expressed expectations because of risks
and uncertainties inherent in future events, particularly those risks identified
under the heading “Risk Factors” following Item 1 in the 2006 Annual Report, and
should not unduly rely on these forward looking statements.
16
RESULTS
OF OPERATIONS
THREE-MONTH
PERIOD ENDED MARCH 31, 2007 VS 2006
Quarter
ended
March
31, 2007
|
Quarter
ended
March
31, 2006
|
Increase
(decrease)
|
%
Increase
(decrease)
|
|||||||||||
Costs
and expenses
|
||||||||||||||
Research
and development
|
||||||||||||||
Stock
based
compensation
|
$
|
103,000
|
$
|
98,000
|
$
|
5,000
|
5.1
|
%
|
|
|||||
Other
research and
development expense
|
$
|
1,576,000
|
$
|
1,588,000
|
$
|
(12,000
|
)
|
(0.8
|
)%
|
|
||||
Total
research and
development expense
|
$
|
1,679,000
|
$
|
1,686,000
|
$
|
(7,000
|
)
|
(0.4
|
)%
|
|
||||
General
and administrative
|
||||||||||||||
Stock
based
compensation
|
$
|
232,000
|
$
|
214,000
|
$
|
18,000
|
8.4
|
%
|
|
|||||
Other
general and
administrative expense
|
$
|
683,000
|
$
|
597,000
|
$
|
86,000
|
14.4
|
%
|
|
|||||
Total
general and
administrative expense
|
$
|
915,000
|
$
|
811,000
|
$
|
104,000
|
12.8
|
%
|
|
|||||
Other
income
|
$
|
30,000
|
$
|
99,000
|
$
|
(69,000
|
)
|
(69.7
|
)%
|
|
||||
Net
loss
|
$
|
2,564,000
|
$
|
2,398,000
|
$
|
166,000
|
6.9
|
%
|
|
During
each of the quarters ended March 31, 2007 and 2006, we had no revenues, and
are
considered a development stage company. We do not expect to have revenues
relating to our technologies prior to March 31, 2008, if at all.
For
the
quarter ended March 31, 2007 research and development expense was $1,679,000
as
compared to $1,686,000 for the quarter ended March 31, 2006. The decrease of
$7,000, less than 1%, is comprised of a $5,000 increase in stock based
compensation and an increase of $567,000 due to increased development activities
of our Oleoyl-estrone product candidate offset by a decrease of $572,000 due
to
decreased development activities of our PTH (1-34) product
candidate.
For
the
three months ended March 31, 2007, general and administrative expense was
$915,000 as compared to $811,000 for the three months ended March 31, 2006.
The
increase of $104,000, or 12.8%, is due primarily to increases of $18,000 in
stock based compensation, of $75,000 in payroll and related costs, of $46,000
in
spending on business development activities partially offset by a decrease
of
$13,000 in insurance costs.
For
the
quarter ended March 31, 2007, other income was $30,000 as compared to $99,000
for the quarter ended March 31, 2006. The decrease of $69,000, or 69.7%, is
due
primarily to a decrease in interest income of approximately $68,000 which
resulted from lower average balances in interest bearing cash and short-term
investment accounts.
Net
loss
for the three months ended March 31, 2007, was $2,564,000 as compared to
$2,398,000 for the three months ended March 31, 2006. The increase of $166,000,
or 6.9%, in net loss is attributable to an increase in general and
administrative expense of $104,000 and a decrease in other income of $69,000,
partially offset by a decrease in research and development expense of
$7,000.
17
LIQUIDITY
AND CAPITAL RESOURCES
From
inception to March 31, 2007, we incurred a deficit during the development stage
of $45.5 million primarily as a result of our net losses and preferred stock
dividends. We expect to continue to incur additional losses through at least
March 31, 2008 and for the foreseeable future thereafter. These losses have
been
incurred through a combination of research and development activities related
to
the various technologies under our control and expenses supporting those
activities.
We
have
financed our operations since inception primarily through equity financing
and
our licensing and sale of certain residual royalty rights. During the three
months ended March 31, 2007, we had a net increase in cash and cash equivalents
of $5.7 million. This increase resulted largely from net proceeds related to
the
sale of common stock of $7.8 million partially offset by net cash used in
operating activities of $2.2 million. Total liquid resources as of March 31,
2007 were $8.7 million compared to $3.0 million at December 31,
2006.
Our
current liabilities as of March 31, 2007 were $2.2 million compared to $1.9
million at December 31, 2006, an increase of $300,000. This increase was
primarily due to increases in accrued liabilities of $44,000 related to the
ongoing clinical trials of OE, an increase in accounts payable of $130,000
and
an increase in accrued bonuses of $97,000. As of March 31, 2007, we had working
capital of $7 million compared to $1.4 million at December 31, 2006. This $5.6
million increase in working capital is primarily due to net proceeds related
to
the sale of common stock of approximately $7.8 million offset by net cash used
in operating activities of $2.2 million during the three months ended March
31,
2007.
On
March
30, 2007, we entered into a series of subscription agreements with various
institutional and other accredited investors for the issuance and sale in a
private placement of an aggregate of 10,185,502 shares of our common stock
for
net proceeds of approximately $7.8 million. Of the total amount of shares
issued, 10,129,947 were sold at a per share price of $0.84, and an additional
55,555 shares were sold to an entity affiliated with a director of the Company,
at a per share price of $0.90, the closing sale price of the common stock on
March 29, 2007. Pursuant to the subscription agreements, we also issued to
the
investors 5-year warrants to purchase an aggregate of 3,564,897 shares of our
common stock at an exercise price of $1.00 per share. The warrants are
exercisable during the period commencing September 30, 2007 and ending March
30,
2012.
Pursuant
to these subscription agreements the Company agreed to file a registration
statement covering the resale of the shares issued in the private placement,
including the shares issuable upon exercise of the investor warrants and the
placement agent warrants with the Securities and Exchange Commission on or
before May 14, 2007 and use its reasonable best efforts to have such
registration statement declared effective by the Securities and Exchange
Commission on or before July 28, 2007. In the event the Company has not filed
such registration statement on or before May 14, 2007 or if the registration
statement has not been declared effective on or before July 28, 2007, then
in
either case the Company shall make compensatory payments to the investors in
an
amount equal to one percent (1%) of the aggregate purchase price paid by the
investors for each monthly period (or prorated portion thereof) in which the
Company is in default of either of these obligations. In
no
event shall the amount of compensatory payments payable by the Company exceed
ten percent (10%) of the aggregate purchase price paid by the
investors.
The
Company filed the registration statement on May 9, 2007.
The
Company engaged Paramount BioCapital, Inc., a related party, as its placement
agent in connection with the private placement. In consideration for its
services, we paid aggregate cash commissions of approximately $600,000 and
issued to Paramount a 5-year warrant to purchase an aggregate of 509,275 shares
at an exercise price of $1.00 per share.
18
We
often
contract with third parties to facilitate, coordinate and perform agreed upon
research and development of our product candidates. To ensure that research
and
development costs are expensed as incurred, we record monthly accruals for
clinical trials and preclinical testing costs based on the work performed under
the contracts.
These
contracts typically call for the payment of fees for services at the initiation
of the contract and/or upon the achievement of certain milestones. This method
of payment often does not match the related expense recognition resulting in
either a prepayment, when the amounts paid are greater than the related research
and development costs recognized, or an accrued liability, when the amounts
paid
are less than the related research and development costs
recognized.
In
March
2006, we entered into a research and development agreement with Swiss Pharma
Contract Ltd., or Swiss Pharma, to perform a Phase 2a clinical study in 100
obese patients of our Oleoyl-estrone product candidate for the treatment of
obesity. The contract requires us to pay up to $2,151,840 to Swiss Pharma for
conducting the study.
In
the
fourth quarter of 2006, we expanded this ongoing Phase 2a clinical trial of
Oleoyl-estrone in obesity study into two new clinical sites in the United
States. Because the size of the study has not been expanded beyond the 100
obese
patients, we do not anticipate the addition of the two new sites to materially
increase our total financial commitment of up to $2,152,000. Such financial
commitment will now be paid to three clinical centers rather than one. We have
completed dosing patients in this Phase 2 a study and expect it to conclude
in
mid-2007.
Expenses
associated with the ongoing clinical trials are recognized on this activity
based basis, therefore, the expense recognition differs from the payment
schedules. Through March 31, 2007, we have recognized a cumulative expense
of
$1,676,000 for this clinical trial and expect the balance of the financial
commitment of approximately $500,000 to be incurred through the conclusion
of
the trial. During the first quarter of 2007, we made cash payments of $535,000
and recognized expense of $546,000. Our prepaid expenses decreased by $156,000
and our accrued liabilities increased by $34,000 during the quarter.
In
the
fourth quarter of 2006, we commenced a Phase 2a study of Oleoyl-estrone in
the
morbidly obese at St. Lukes/Roosevelt hospital in New York. The financial
commitment for this study is approximately $685,000.
In
the
first quarter of 2007, we expanded this ongoing Phase 2a clinical trial in
the
morbidly obese into two new clinical sites, also in the United States. The
scope
and financial commitment of this study remains unchanged. We have completed
dosing patients in this Phase 2 a study and expect it to conclude in
mid-2007.
Expenses
associated with the ongoing clinical trials are recognized on this activity
based basis, therefore, the expense recognition differs from the payment
schedules. Through March 31, 2007, we have recognized a cumulative expense
of
$119,000 for this clinical trial and expect the balance of the financial
commitment of approximately $570,000 to be incurred through the conclusion
of
the trial. During the first quarter of 2007, we made cash payments of $46,000
and recognized expense of $65,000. Our prepaid expenses decreased by $4,000
and
our accrued liabilities decreased by $23,000 during the quarter.
Expenses
associated with the ongoing clinical trials are recognized on this activity
based basis, therefore, the expense recognition differs from the payment
schedules. During the first quarter of 2007 we reduced our prepaid expenses
by
$156,000 and recognized $103,000 of accrued expense related to the common
obesity clinical trial.
19
Our
available working capital and capital requirements will depend upon numerous
factors, including progress of our research and development programs, our
progress in and the cost of ongoing and planned pre-clinical and clinical
testing, the timing and cost of obtaining regulatory approvals, the cost of
filing, prosecuting, defending, and enforcing patent claims and other
intellectual property rights, competing technological and market developments,
changes in our existing collaborative and licensing relationships, the resources
that we devote to commercializing capabilities, the status of our competitors,
our ability to establish collaborative arrangements with other organizations
and
our need to purchase additional capital equipment.
Our
continued operations will depend on whether we are able to raise additional
funds through various potential sources, such as equity and debt financing,
other collaborative agreements, strategic alliances, and our ability to realize
the full potential of our technology in development. Such additional funds
may
not become available on acceptable terms and there can be no assurance
that any additional funding that we do obtain will be sufficient to meet our
needs in the long term. Through
March 31, 2007, a significant portion of our financing has been through private
placements of common stock, preferred stock and warrants to purchase common
stock. Until our operations generate significant revenues and cash flows from
operating activities, we will continue to fund operations from cash on hand
and
through the similar sources of capital previously described. We can give no
assurances that any additional capital that we are able to obtain will be
sufficient to meet our needs. Management
believes that we will continue to incur net losses and negative cash flows
from
operating activities for the foreseeable future. Based on the resources
available to us at March 31, 2007, management believes that we will need
additional equity or debt financing or will need to generate revenues through
licensing our products or entering into strategic alliances to be able to
sustain our operations into 2008 and we will need additional financing
thereafter until we can achieve profitability, if ever.
Although
we currently have sufficient capital to fund our anticipated 2007 expenditures,
we will need to raise additional capital in order to complete the anticipated
development programs for each of our research and development projects. If
we
are unable to raise such additional capital, we may have to sublicense our
rights to a third party as a means of continuing development, or, although
less
likely, we may be required to abandon further development efforts altogether,
either of which would have a material adverse effect on the prospects of our
business.
In
January 2007 we received notice from the staff of the American Stock Exchange,
or AMEX, indicating that we were not in compliance with certain continued
listing standards set forth in the American Stock Exchange Company Guide.
Specifically, the American Stock Exchange notice cited our failure to comply,
as
of September 30, 2006, with section 1003(a)(ii) of the AMEX Company Guide as
we
had less than the $4,000,000 of stockholders’ equity and had losses from
continuing operations and/or net losses in three of its four most recent fiscal
years and with section 1003(a) (iii) which requires us to maintain $6,000,000
of
stockholders’ equity if we have experienced losses from continuing operations
and /or net losses in its five most recent fiscal years.
In
order
to maintain our AMEX listing, we were required to submit a plan to AMEX advising
the exchange of the actions we have taken, or will take, that would bring us
into compliance with all the continued listing standards by April 16, 2008.
We
submitted such a plan in February 2007. AMEX accepted our plan in March 2007,
so
we are now able to continue our listing during the period ending April 16,
2008,
during which time we will be subject to periodic review to determine if we
are
making progress consistent with the plan. If we are not in compliance with
the
continued listing standards at the end of the plan period, or if we do not
make
progress consistent with the plan during the plan period, AMEX staff may
initiate delisting proceedings. There can be no assurance that we will be able
to make progress consistent with such plan.
20
If
we
fail to make sufficient progress under our plan, AMEX may initiate delisting
proceedings. If our common stock is
delisted
from AMEX, trading in our common stock would likely be conducted on the OTC
Bulletin Board, a regulated quotation service. If our common stock is delisted
from the AMEX, the liquidity of our common stock may be reduced, not only in
terms of the number of shares that can be bought and sold at a given price,
but
also through delays in the timing of transactions and reduction in security
analysts’ and the media’s coverage of us. This may result in lower prices for
our common stock than might otherwise be obtained and could also result in
a
larger spread between the bid and asked prices for our common stock.
Further,
if we are delisted from AMEX, we may find it more difficult to raise additional
capital through sales of our common stock or other equity
securities.
RESEARCH
AND DEVELOPMENT PROJECTS
Our
success in developing each of our research and development projects is dependent
on numerous factors, including raising further capital, unforeseen safety
issues, lack of effectiveness, significant unforeseen delays in the clinical
trial and regulatory approval process, both of which could be extremely costly,
and inability to monitor patients adequately before and after treatments. The
existence of any of these factors could increase our development costs or make
successful completion of development impractical, which would have a material
adverse affect on the prospects of our business.
Oleoyl-estrone
We
completed Phase 1a and Phase 1b clinical trials in May 2005 and July 2005,
respectively, and released data on both trials in October 2005. The Phase 1a
and
Phase 1b clinical trials were dose escalation studies to determine the safety
and tolerability of defined doses of orally administered Oleoyl-estrone in
obese
adult volunteers as well as the pharmacokinetic profile (i.e. the manner in
which the drug is absorbed, distributed, metabolized and excreted by the body)
of Oleoyl-estrone in both men and women.
Extensive
preclinical studies of OE have shown evidence of weight loss, sustained weight
loss after dosing stops, and reduced food intake. These studies have also shown
evidence of beneficial changes in blood glucose and cholesterol levels. This
work is supported by dozens of peer-reviewed journal publications over the
past
ten years. Results of the Phase 1 clinical studies with OE, reported in October
2005, showed OE was clinically well tolerated at all dose levels. The Phase
1
data in humans points to similar beneficial effects of OE as shown in
preclinical studies including weight loss, sustained weight loss and beneficial
changes in blood glucose and cholesterol. Clinical laboratory findings included
dose-dependent elevations in estrone and estradiol levels, as well as reductions
in testosterone levels; all had returned to baseline by the first follow-up
visit, 8 days after dosing stopped.
In
March
2006, we commenced a Phase 2a clinical study evaluating oral Oleoyl-estrone
in
obese adult subjects with a body mass index (BMI) of 27-38.9. This randomized,
double-blind, placebo-controlled, parallel group study is designed to evaluate
the safety and preliminary efficacy of oral Oleoyl-estrone in 100 common obese
male and female subjects. Enrollment in this study was completed in February
2007. We have completed patient dosing, expect the last patient to complete
the
study in mid-June 2007, and plan to complete data analysis in July
2007.
21
In
the
fourth quarter of 2006, we also commenced a Phase 2a clinical study evaluating
oral Oleoyl-estrone in 24 morbidly obese male subjects (BMI 40-55). F. Xavier
Pi-Sunyer, MD, of St. Luke’s-Roosevelt Hospital Center, University Hospital of
Columbia University College of Physicians and Surgeons is serving as Principal
Investigator. We have completed patient dosing and expect the study conclude
mid-year 2007.
To
date,
we have incurred $13,727,000 of project costs related to our development of
Oleoyl-estrone, including milestone payments triggered under our license
agreement for Oleoyl-estrone, of which $1,426,000 was incurred in the first
three months of 2007. Since Oleoyl-estrone is regarded by the FDA as a new
entity, it is not realistic to predict the size and the design of future studies
at this time.
PTH
(1-34)
We
are
developing PTH (1-34) as a topical treatment for psoriasis. In
2003,
researchers, led by Michael Holick, PhD, MD, Professor of Medicine, Physiology,
and Biophysics at Boston University Medical Center, reported positive results
from a US Phase 1 and 2 clinical trial evaluating the safety and efficacy of
PTH
(1-34) as a topical treatment for psoriasis. This double-blind, controlled
trial
in 15 patients compared PTH (1-34) formulated in the Novasome® Technology versus
the Novasome® vehicle alone. Following 8 weeks of treatment, the topical
application of PTH (1-34) resulted in complete clearing of the treated lesion
in
60% of patients and partial clearing in 85% of patients. Additionally, there
was
a statistically significant improvement in the global severity score. Ten
patients continued receiving PTH (1-34) in an open label extension study in
which the Psoriasis Area and Severity Index (PASI) was measured; PASI
improvement across all 10 patients achieved statistically significant
improvement compared to baseline. This study showed PTH (1-34) to be well
tolerated and efficacious for the treatment of plaque psoriasis with no patients
experiencing any clinically significant adverse events.
Due
to
the high response rate seen in patients in the initial trial with PTH (1-34),
we
believe that it may have an important clinical advantage over current topical
psoriasis treatments. A physician sponsored Investigative New Drug application
Phase 2a trial involving PTH (1-34) was initiated in December 2005 under the
auspices of Boston University. In April 2006, we reported a delay in this
planned Phase 2a clinical study of topical PTH (1-34) due to a formulation
issue. We believe we have identified and resolved this issue. An improved
formulation has been produced and several patent applications are being
prepared. We expect to initiate clinical activities during 2007.
To
date,
we have incurred $2,939,000 of project costs related to our development of
PTH
(1-34). These project costs have been incurred since April 1, 2005, the date
of
the Tarpan Therapeutics acquisition, $243,000 of which was incurred in the
first
three months of 2007.
Lingual
spray propofol
We
are
developing propofol lingual spray, which we in-licensed from NovaDel Pharma,
Inc. for light to medium sedation, on a Section 505(b)(2) bioequivalence
regulatory pathway toward approval by the U.S. Food and Drug Administration
(FDA). In January 2005, the FDA accepted our IND for propofol lingual spray,
allowing us to commence clinical trials. The FDA has indicated to us in
discussions that we may proceed to a pivotal Phase 3 trial of propofol lingual
spray following completion of Phase 1 trials. We continue to pursue a revised
product presentation to meet the market opportunity and are working with several
external experts to achieve these goals. As
a
result there was minimal spending on Propofol in the first three months of
2007.
22
To
date,
we have incurred $2,967,000 of project costs related to our development of
propofol lingual spray, of which $10,000 was incurred in the first three months
of 2007.
Altoderm
In
April
2007 we entered into a license agreement with Thornton & Ross LTD, or
T&R, pursuant to which we acquired exclusive North American rights to a
dermatology product candidate called Altoderm™.
Altoderm™
is a
novel, proprietary formulation of topical cromolyn sodium and is designed to
enhance the absorption of cromolyn sodium in order to treat atopic dermatitis,
or “eczema.” This product candidate is currently being tested in a Phase 3
clinical trial in the United Kingdom. In a previously completed randomized,
double-blind, placebo-controlled, parallel-group, Phase 3 clinical study in
the
United Kingdom the compound was administered for 12 weeks to 114 child subjects
with moderately severe atopic dermatitis. In the study results, published in
the
British Journal of Dermatology in February 2005, Altoderm demonstrated a
statistically significant reduction in symptoms. During the study, subjects
were
permitted to continue with their existing treatment, in most cases this
consisted of emollients and topical steroids. A positive secondary outcome
of
the study was a reduction in the use of topical steroids for the
Altoderm-treated subjects. See Note 7 - Subsequent Events.
Altolyn
In
addition to the Altoderm™
license
agreement, we entered into a separate license agreement with T&R pursuant to
which we acquired exclusive North American rights to develop and commercialize
Altolyn™.
Altolyn™
is a
proprietary, site specific, tablet formulation of oral cromolyn sodium for
the
treatment of mastocytosis. This novel formulation is designed to provide optimal
availability by preferentially releasing the drug in the upper part of the
small
intestine, the purported site of action. In addition to mastocytosis early
clinical experience in the United Kingdom suggests promising activity in
patients with various allergic disorders, including inflammatory bowel
conditions. Oral cromolyn sodium is the active ingredient in Gastrocrom® an oral
liquid solution that is currently FDA approved for the treatment of
mastocytosis. See Note 7 - Subsequent Events.
Off-Balance
Sheet Arrangements
We
have
not entered into any off-balance sheet arrangements.
23
Item
3. Quantitative and Qualitative Disclosure About Market
Risk
Our
exposure to market risk is confined to our cash and cash equivalents. We have
attempted to minimize risk by investing in high-quality financial instruments,
primarily money market funds with no security having an effective duration
longer than 90 days. If the market interest rate decreases by 100 basis points
or 1%, the fair value of our cash and cash equivalents portfolio would have
minimal to no impact on the carrying value of our portfolio. We did not hold
any
derivative instruments as of March 31, 2007, and we have never held such
instruments in the past.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
As
of
March 31, 2007, we carried out an evaluation, under the supervision and with
the
participation of our Chief Executive Officer and Chief Financial Officer, of
the
effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities
Exchange Act of 1934, as amended). Based upon that evaluation, our Chief
Executive Officer and Chief Financial Officer concluded that our disclosure
controls and procedures as of that date were effective to ensure that
information required to be disclosed in the reports we file under the Securities
and Exchange Act is recorded, processed, summarized and reported on an accurate
and timely basis.
The
Company’s management, including its Chief Executive Officer and its Chief
Financial Officer, does not expect that disclosure controls or internal controls
over financial reporting will prevent all errors or all instances of fraud,
even
as the same are improved to address any deficiencies. The design of any system
of controls is based in part upon certain assumptions about the likelihood
of
future events, and there can be no assurance that any design will succeed in
achieving its stated goals under all potential future conditions. A control
system, no matter how well designed and operated, can provide only reasonable,
not absolute, assurance that the control system’s objectives will be met. Over
time, controls may become inadequate because of changes in conditions or
deterioration in the degree of compliance with policies or procedures. Further,
the design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their
costs. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that all control issues and instances
of fraud, if any, within the Company have been detected.
Because
of the inherent limitation of a cost-effective control system, misstatements
due
to error or fraud may occur and not be detected. These inherent limitations
include the realities that judgments in decision-making can be faulty, and
that
breakdowns can occur because of a simple error or mistake. Controls can also
be
circumvented by the individual acts of some persons, by collusion of two or
more
people, or by management override of the controls.
Changes
in Internal Control
During
the quarter ended March 31, 2007, there were no changes in internal controls
over financial reporting that have materially affected, or are reasonably likely
to materially affect, our internal controls over financial
reporting.
24
PART
II - OTHER INFORMATION
Item
1A. Risk
Factors
We
have
not had material changes to our risk factor disclosure in our Annual Report
on
Form 10-KSB for the year ended December 31, 2006 under the caption “Risk
Factors” following Item 1 of such report.
Item
6.
Exhibits
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).
|
31.1 |
Certification
of Chief Executive Officer
|
31.2 |
Certification
of Chief Financial Officer
|
32. | Certifications of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
25
SIGNATURES
In
accordance with the requirements of the Exchange Act of 1934, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto
duly
authorized.
MANHATTAN PHARMACEUTICALS, INC. | |
Date: May 15, 2007 |
By:
/s/ Douglas Abel
Douglas
Abel
President
and Chief Executive Officer
|
Date: May 15, 2007 | By:
/s/ Michael G. McGuinness
Michael
G. McGuinness
Chief
Financial Officer
|
26
Index
to Exhibits Filed with this Report
Exhibit No. | Description |
31.1 |
Certification
of Chief Executive Officer
|
31.2 |
Certification
of Chief Financial Officer
|
32. | Certifications of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
27