TG THERAPEUTICS, INC. - Quarter Report: 2007 June (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 June 30, 2007
OR
o |
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 o
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 o No
x
As
of
August 1, 2007 there were 70,474,232 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
|
17
|
Item
3.
|
Quantitative
and Qualitative Disclosure About Market Risk
|
25
|
Item
4.
|
Controls
and Procedures
|
25
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1A.
|
Risk
Factors
|
26
|
Item
6.
|
Exhibits
|
26
|
Signatures
|
28
|
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 Securities and Exchange Act of 1934.
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
June
30,
|
December
31,
|
||||||
|
2007
|
2006
|
|||||
(Unaudited)
|
(See
Note 1)
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
4,790,589
|
$
|
3,029,118
|
|||
Prepaid
expenses
|
352,657
|
264,586
|
|||||
Total
current assets
|
5,143,246
|
3,293,704
|
|||||
Property
and equipment, net
|
62,904
|
83,743
|
|||||
Other
assets
|
70,506
|
70,506
|
|||||
Total
assets
|
$
|
5,276,656
|
$
|
3,447,953
|
|||
Liabilities
and Stockholders’ Equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,001,849
|
$
|
1,393,296
|
|||
Accrued
expenses
|
1,528,406
|
550,029
|
|||||
Total
liabilities
|
2,530,255
|
1,943,325
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders’
equity:
|
|||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares
issued and
outstanding at June 30, 2007 and December 31, 2006
|
—
|
—
|
|||||
Common
stock, $.001 par value. Authorized 150,000,000 shares; 70,474,232
and
60,120,038 shares issued and outstanding at June 30, 2007 and December
31,
2006, respectively
|
70,474
|
60,120
|
|||||
Additional
paid-in capital
|
53,101,402
|
44,411,326
|
|||||
Deficit
accumulated during the development stage
|
(50,425,475
|
)
|
(42,966,818
|
)
|
|||
Total
stockholders’ equity
|
2,746,401
|
1,504,628
|
|||||
Total
liabilities and stockholders' equity
|
$
|
5,276,656
|
$
|
3,447,953
|
See
accompanying notes to unaudited condensed consolidated financial
statements.
4
(A
Development Stage Company)
Condensed
Consolidated Statements of Operations
(Unaudited)
Cumulative
|
||||||||||||||||
period
from
|
||||||||||||||||
August 6, 2001
|
||||||||||||||||
(inception) to
|
||||||||||||||||
Three Months ended June 30,
|
Six months ended June 30,
|
June
30,
|
||||||||||||||
2007
|
2006
|
2007
|
2006
|
2007
|
||||||||||||
|
||||||||||||||||
Revenue
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||
Costs
and expenses:
|
||||||||||||||||
Research
and development
|
3,871,634
|
1,570,905
|
5,551,082
|
3,257,346
|
23,504,438
|
|||||||||||
General
and administrative
|
1,052,374
|
786,391
|
1,967,098
|
1,597,336
|
12,211,191
|
|||||||||||
In-process
research and development charge
|
-
|
—
|
—
|
—
|
11,887,807
|
|||||||||||
Impairment
of intangible assets
|
-
|
—
|
—
|
—
|
1,248,230
|
|||||||||||
Loss
on disposition of intangible assets
|
-
|
—
|
—
|
—
|
1,213,878
|
|||||||||||
Total
operating expenses
|
4,924,008
|
2,357,296
|
7,518,180
|
4,854,682
|
50,065,544
|
|||||||||||
Operating
loss
|
(4,924,008
|
)
|
(2,357,296
|
)
|
(7,518,180
|
)
|
(4,854,682
|
)
|
(50,065,544
|
)
|
||||||
Other
(income) expense:
|
||||||||||||||||
Interest
and other income
|
(29,608
|
)
|
(86,483
|
)
|
(59,998
|
)
|
(185,189
|
)
|
(769,714
|
)
|
||||||
Interest
expense
|
-
|
238
|
475
|
238
|
26,033
|
|||||||||||
Realized
gain on sale of marketable equity securities
|
-
|
—
|
—
|
(490
|
)
|
(76,032
|
)
|
|||||||||
Total
other income
|
(29,608
|
)
|
(86,245
|
)
|
(59,523
|
)
|
(185,441
|
)
|
(819,713
|
)
|
||||||
Net
loss
|
(4,894,400
|
)
|
(2,271,051
|
)
|
(7,458,657
|
)
|
(4,669,241
|
)
|
(49,245,831
|
)
|
||||||
Preferred
stock dividends (including imputed amounts)
|
-
|
—
|
—
|
—
|
(1,179,644
|
)
|
||||||||||
Net
loss applicable to common shares
|
$
|
(4,894,400
|
)
|
$
|
(2,271,051
|
)
|
$
|
(7,458,657
|
)
|
$
|
(4,669,241
|
)
|
$
|
(50,425,475
|
)
|
|
Net
loss per common share:
|
||||||||||||||||
Basic
and diluted
|
$
|
(0.07
|
)
|
$
|
(0.04
|
)
|
$
|
(0.11
|
)
|
$
|
(0.08
|
)
|
||||
Weighted
average shares of common stock outstanding:
|
||||||||||||||||
Basic
and diluted
|
70,463,543
|
60,116,174
|
65,377,865
|
60,104,500
|
See
accompanying notes to unaudited condensed consolidated financial
statements.
5
(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
|
7,843,967
|
—
|
—
|
—
|
—
|
—
|
7,854,153
|
|||||||||||||||||||||||
Common
stock issued to directors at $0.72 per share in satisfaction of
accounts
payable
|
—
|
—
|
27,776
|
28
|
19,972
|
—
|
—
|
—
|
—
|
20,000
|
||||||||||||||||||||||||
Common
stock issued in connection with in-licensing agreement at
$0.90 per share
|
—
|
—
|
125,000
|
125
|
112,375
|
—
|
—
|
—
|
—
|
—
|
112,500
|
|||||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
706,549
|
—
|
—
|
—
|
—
|
—
|
706,549
|
|||||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
10,327
|
15
|
7,219
|
—
|
—
|
—
|
—
|
—
|
7,234
|
|||||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
5,589
|
—
|
(6
|
)
|
—
|
—
|
—
|
—
|
—
|
(6
|
)
|
|||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
-
|
—
|
(7,458,657
|
)
|
—
|
—
|
—
|
(7,458,657
|
)
|
|||||||||||||||||||||
Balance
at June 30, 2007
|
—
|
$
|
—
|
70,474,232
|
$
|
70,474
|
$
|
53,101,402
|
$
|
—
|
$
|
(50,425,475
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
2,746,401
|
See
accompanying notes to unaudited condensed consolidated financial
statements.
6
(A
Development Stage Company)
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
|
Cumulative
|
|||||||||
period
from
|
||||||||||
August 6, 2001
|
||||||||||
(inception) to
|
||||||||||
Six
months ended June 30,
|
June
30,
|
|||||||||
2007
|
2006
|
2007
|
||||||||
|
||||||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(7,458,657
|
)
|
$
|
(4,669,241
|
)
|
$
|
(49,245,831
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Share-based
compensation
|
706,549
|
619,128
|
2,630,576
|
|||||||
Shares
issued in connection with in-licensing agreement
|
112,500
|
—
|
112,500
|
|||||||
Amortization
of intangible assets
|
—
|
—
|
145,162
|
|||||||
Gain
on sale of marketable equity securities
|
—
|
(490
|
)
|
(76,032
|
)
|
|||||
Depreciation
|
29,974
|
29,484
|
177,454
|
|||||||
Non
cash portion of in-process research and development charge
|
—
|
—
|
11,721,623
|
|||||||
Loss
on impairment and disposition of intangible assets
|
—
|
—
|
2,462,108
|
|||||||
Other
|
—
|
—
|
5,590
|
|||||||
Changes
in operating assets and liabilities, net of acquisitions:
|
||||||||||
Increase
in prepaid expenses and other current assets
|
(88,071
|
)
|
(780,863
|
)
|
(294,412
|
)
|
||||
Increase
in other assets
|
—
|
—
|
(70,506
|
)
|
||||||
Increase/(decrease)
in accounts payable
|
(371,447
|
)
|
345,243
|
1,422,063
|
||||||
Increase
in accrued expenses
|
978,377
|
203,778
|
988,085
|
|||||||
Net
cash used in operating activities
|
(6,090,775
|
)
|
(4,252,961
|
)
|
(30,021,620
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchase
of property and equipment
|
(9,135
|
)
|
(12,832
|
)
|
(230,636
|
)
|
||||
Cash
acquired (paid) in connection with acquisitions, net
|
—
|
—
|
(26,031
|
)
|
||||||
Proceeds
from sale (payments for purchase)of short-term investments,
net
|
—
|
500,000
|
435,938
|
|||||||
Proceeds
from sale of license
|
—
|
—
|
200,001
|
|||||||
Net
cash provided by (used in) investing activities
|
(9,135
|
)
|
487,168
|
379,272
|
||||||
Cash
flows from financing activities:
|
||||||||||
Repayments
of notes payable to stockholders
|
—
|
—
|
(884,902
|
)
|
||||||
Payment
for fractional shares for preferred stock dividends
|
—
|
—
|
(2,286
|
)
|
||||||
Proceeds
related to sale of common stock, net
|
7,854,153
|
(15,256
|
)
|
25,898,230
|
||||||
Proceeds
from sale of preferred stock, net
|
—
|
—
|
9,046,176
|
|||||||
Proceeds
from exercise of warrants and stock options
|
7,228
|
—
|
138,219
|
|||||||
Other,
net
|
—
|
—
|
237,500
|
|||||||
Net
cash (used in) provided by financing activities
|
7,861,381
|
(15,256
|
)
|
34,432,937
|
||||||
Net
(decrease) increase in cash and cash equivalents
|
1,761,471
|
(3,781,049
|
)
|
4,790,589
|
||||||
Cash
and cash equivalents at beginning of period
|
3,029,118
|
9,826,336
|
—
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
4,790,589
|
$
|
6,045,287
|
$
|
4,790,589
|
||||
Supplemental
disclosure of cash flow information:
|
||||||||||
Interest
paid
|
$
|
475
|
$
|
238
|
$
|
26,033
|
||||
Supplemental
disclosure of noncash investing and financing activities:
|
||||||||||
Common
stock issued in satisfaction of accounts payable
|
$
|
20,000
|
$
|
—
|
$
|
770,000
|
||||
Imputed
preferred stock dividend
|
—
|
—
|
418,182
|
|||||||
Preferred
stock dividends accrued
|
—
|
—
|
761,462
|
|||||||
Conversion
of preferred stock to common stock
|
—
|
—
|
9,046,176
|
|||||||
Preferred
stock dividends paid by issuance of shares
|
—
|
—
|
759,134
|
|||||||
Issuance
of common stock for acquisitions
|
—
|
—
|
13,389,226
|
|||||||
Issuance
of common stock in connection with in-licensing agreement
|
112,500
|
—
|
112,500
|
|||||||
Marketable
equity securities received in connection with sale of
license
|
—
|
—
|
359,907
|
|||||||
Net
liabilities assumed over assets acquired in business
combination
|
—
|
—
|
(675,416
|
)
|
||||||
Cashless
exercise of warrants
|
6
|
27
|
33
|
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 and six month periods ended June 30, 2007.
As
of
June 30, 2007, the Company has not generated any revenues from its operations
and is considered to be a development stage company.
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
January 1, 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.
8
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
New
Accounting Pronouncements
In
March
2007, the FASB issued FASB Staff Position EITF 07-03 (“FSP 07-03”), Accounting
for Nonrefundable Advance Payments for Goods or Services to Be Used in Future
Research and Development Activities. FSP 07-03 addresses whether nonrefundable
advance payments for goods or services that will be used or rendered for
research and development activities should be expensed when the advance payment
is made or when the research and development activity has been performed.
FSP
07-03 will be effective for fiscal years beginning after December 15, 2007,
and interim periods within those fiscal years. The Company currently believes
that the adoption of FSP 07-03 will have no material impact on its financial
position or results of operations.
(2) |
LIQUIDITY
|
The
Company incurred a net loss of $7,458,657 and negative cash flows from operating
activities of $6,090,775 for the six months ended June 30, 2007. The net
loss
from date of inception, August 6, 2001 to June 30, 2007 amounts to
$49,245,831.
Management
believes that the Company will continue to incur net losses through at least
June 30, 2008, and for the foreseeable future thereafter. Based on the resources
of the Company available at June 30, 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 18,634,521 and 13,142,729 as of June 30, 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 and six month periods ending June 30, 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. The Company recognized share-based
compensation cost of $371,339 and $307,216, for the three month periods ended
June 30, 2007 and 2006 respectively, and $706,549 and $619,128 for the six
month
periods ended June 30, 2007 and 2006, respectively in accordance with Statement
123(R). 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 June 30, 2007 and 2006, net of
amortization, the Company recognized general and administrative and research
and
development expenses of $185 and $3,556, respectively for the three-and six
months ended June 30, 2007 and $(50,292) and $(26,321) for the three and
six
months ended June 30, 2006.
The
Company has allocated share-based compensation costs to general and
administrative and research and development expenses as follows:
10
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Three months ended June 30,
|
Six months ended June 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
General
and administrative expense:
|
|||||||||||||
Share-based
employee compensation cost
|
$
|
249,623
|
$
|
252,361
|
$
|
471,544
|
$
|
444,977
|
|||||
Share-based
consultant and non-employee (credit) cost
|
—
|
(28,450
|
)
|
10,550
|
(22,861
|
)
|
|||||||
$
|
249,623
|
$
|
223,911
|
$
|
482,094
|
$
|
422,116
|
||||||
Research
and development expense
|
|||||||||||||
Share-based
employee compensation cost
|
$
|
121,531
|
$
|
105,147
|
$
|
231,449
|
$
|
200,472
|
|||||
Share-based
consultant and non-employee (credit) cost
|
185
|
(21,842
|
)
|
(6,994
|
)
|
(3,460
|
)
|
||||||
$
|
121,716
|
$
|
83,305
|
$
|
224,455
|
$
|
197,012
|
||||||
Total
share-based cost
|
$
|
371,339
|
$
|
307,216
|
$
|
706,549
|
$
|
619,128
|
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. The Company increased the number
of
shares of common stock reserved for issuance under the 2003 Plan in August
2005
by 2,000,000 shares and in May 2007 by 3,000,000 shares. At June 30, 2007,
10,400,000 shares were authorized for issuance. Under the 2003 Plan at June
30,
2007 options to purchase 7,096,598 shares were outstanding and 27,776 shares
of
common stock have been issued leaving a total of 3,275,626 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 three
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 1,342,500
shares of common stock during the six months ended June 30, 2007 of which
options to purchase 300,000 and 97,500 shares of common stock were granted
at an
exercise price of $0.72 per share to directors and employees, respectively,
options to purchase 75,000 shares of common stock were granted to an employee
at
an exercise price of $0.82 per share, and options to purchase 870,000 shares
of
common stock were granted to officers at an exercise price of $0.95 per share.
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 June 30, 2007, options to purchase 1,137,240 shares
were
outstanding under the 1995 Plan and no shares were reserved for future stock
option grants.
11
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
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.
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 June 30,
|
Six
months ended June 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Expected
Volatility
|
79.7
- 93.2
|
%
|
55
|
%
|
79.7
- 93.2
|
%
|
55
|
%
|
|||||
Dividend
yield
|
—
|
—
|
—
|
—
|
|||||||||
Expected
term (in years)
|
6
- 8
|
4
|
6
- 8
|
4
|
|||||||||
Risk-free
interest rate
|
4.56%
- 4.96
|
%
|
4.88
|
%
|
4.56%
- 4.96
|
%
|
4.88
|
%
|
12
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
A
summary
of the status of the Company’s outstanding stock options as of June 30, 2007 and
changes during the six 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
|
|||||||||||||
Officers
|
870,000
|
||||||||||||
Directors
|
300,000
|
||||||||||||
Employees
|
172,500
|
||||||||||||
Total
Granted
|
1,342,500
|
0.88
|
|||||||||||
Exercised
|
-
|
-
|
|||||||||||
Cancelled
|
(109,166
|
)
|
0.95
|
||||||||||
Outstanding
at
|
|||||||||||||
June
30, 2007
|
8,233,838
|
$
|
1.25
|
7.43
|
$
|
387,171
|
|||||||
Options
exercisable at
|
|||||||||||||
June
30, 2007
|
5,102,546
|
$
|
1.30
|
6.95
|
$
|
341,821
|
|||||||
Weighted-average
|
|||||||||||||
fair
value of options
|
|||||||||||||
granted
during the
|
|||||||||||||
six
months ended
|
|||||||||||||
June
30, 2007
|
$
|
0.63
|
As
of
June 30, 2007, the total compensation cost related to non-vested option
awards
not yet recognized is $1,419,413. The weighted average period over which
it is
expected to be recognized is approximately 1.2 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.
13
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(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.
Expenses
associated with the recently concluded clinical trials of
Oleoyl-estrone in
common
obesity and morbid obesity were recognized on this activity-based basis.
At June
30, 2007 we recognized prepaid expense of $9,000 and accrued expenses of
$267,000 related to these clinical trials. The remaining financial commitments
for these clinical trials are negligible.
(6) |
RECENTLY
COMPLETED IN-LICENSING
TRANSACTIONS
|
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. These amounts have been included in research and development
as
fees associated with the in-licensing 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.
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. This amount is included in research and
development as a fee associated with the in-licensing 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%
of the royalties received by the Company under such sublicense agreements.
14
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Hedrin
License Agreement
On
June
26, 2007, the Company entered into an exclusive license agreement for “Hedrin”
(the “Hedrin Agreement”) with T&R and Kerris, S.A. (“Kerris”). Pursuant to
the Hedrin Agreement, the Company has acquired an exclusive North American
license to certain patent rights and other intellectual property relating
to
Hedrin(TM), a non-insecticide product candidate for the treatment of head
lice.
In addition, on June 26, 2007, the Company entered into a Supply Agreement
with
T&R pursuant to which T&R will be the Company’s exclusive supplier of
Hedrin product.
In
consideration for the license, the Company agreed to issue to T&R and Kerris
(jointly, the “Licensor”) a combined total of 150,000 shares of its common stock
upon the execution of the Hedrin Agreement, which were issued in August
2007. In
addition, the Company also agreed to make a cash payment of $600,000 to
the
Licensor no later than July 3, 2007. These amounts have been accrued and
included in research and development as fees associated with the in-licensing
agreement. Further, the Company agreed to make future milestone payments
to the
Licensor in the aggregate amount of $2,500,000 upon the achievement of
various
clinical, regulatory, and patent issuance milestones, as well as up to
$2,500,000 in a one-time success fee based on aggregate sales of the product
by
the Company and its licensees of at least $50,000,000. The Company also
agreed
to pay royalties of 8% (or, under certain circumstances, 4%) on net sales
of
licensed products. On a country-by-country basis, in the event there are
no
patent issues covering the Hedrin product, the obligation to pay royalties
ends
10 years from the date of first commercial sale. The Company’s exclusivity under
the License Agreement is subject to an annual minimum royalty payment of
$1,000,000 (or, under certain circumstances, $500,000) in each of the third
through seventh years following the first commercial sale of Hedrin. The
Company
may sublicense its rights under the Hedrin Agreement with the consent of
Licensor and the proceeds resulting from such sublicenses will be shared
with
the Licensor.
Pursuant
to the Supply Agreement, the Company has agreed that it and its sublicensees
will purchase their respective requirements of the Hedrin product from
T&R
at agreed upon prices. Under certain circumstances where T&R is unable to
supply Hedrin products in accordance with the terms and conditions of the
Supply
Agreement, the Company may obtain products from an alternative supplier
subject
to certain conditions. The term of the Supply Agreement ends upon termination
of
the Hedrin Agreement.
15
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(7) |
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.
Pursuant
to these subscription agreements the Company filed 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 May 9, 2007, which
was
declared effective by the Securities and Exchange Commission on May 18,
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.
(8) |
SUBSEQUENT
EVENTS
|
Oleoyl-estrone –
results of Phase 2a studies
On
July
9, 2007 the Company announced the results of its two Phase 2a clinical
trials of
oral Oleoyl-estrone (“OE”). The results of both randomized, double-blind,
placebo controlled studies, one in common obesity and the other in morbid
obesity, demonstrated no statistically or clinically meaningful placebo
adjusted
weight loss for any of the treatment arms evaluated. Based on these results,
the
Company is discontinuing its Oleoyl-estrone programs in both common obesity
and
morbid obesity.
Propofol
Lingual Spray
On
July
9, 2007 the Company announced that it is discontinuing development and
intends
to pursue appropriate out-licensing opportunities for Propofol Lingual
Spray for
pre-procedural sedation.
16
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 and six month periods ended June 30, 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 four product candidates in
development:
·
|
Topical
PTH (1-34) for the treatment of
psoriasis;
|
·
|
Altoderm,
a proprietary formulation of topical cromolyn sodium for the
treatment of
atopic dermatitis;
|
·
|
Altolyn,
a proprietary site specific tablet formulation of oral cromolyn
sodium for
the treatment of mastocytosis;
|
·
|
and
Hedrin, a novel, non-insecticide treatment for head
lice.
|
We
have
not received regulatory approval for, or generated commercial revenues
from
marketing or selling any drugs.
We
have
recently announced that we are discontinuing development of two product
candidates, oral OE and Propofol Lingual Spray.
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. You 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 Annual Report, and
should not unduly rely on these forward looking statements.
17
RESULTS
OF OPERATIONS
SIX-MONTH
PERIOD ENDED JUNE 30, 2007 VS 2006
Six month
period ended June 30, 2007 |
Six month
period ended June 30, 2006 |
Increase
(decrease) |
% Increase
(decrease) |
||||||||||
Costs
and expenses
|
|||||||||||||
Research
and development
|
|||||||||||||
Stock
based compensation
|
$
|
224,000
|
$
|
197,000
|
$
|
27,000
|
13.7
|
%
|
|||||
In-license
and related fees
|
$
|
1,803,000
|
$
|
250,000
|
$
|
1,553,000
|
621.2
|
%
|
|||||
Other
research and development expense
|
$
|
3,524,000
|
$
|
2,810,000
|
$
|
714,000
|
25.4
|
%
|
|||||
Total
research and development expense
|
$
|
5,551,000
|
$
|
3,257,000
|
$
|
2,294,000
|
70.4
|
%
|
|||||
General
and administrative
|
|||||||||||||
Stock
based compensation
|
$
|
482,000
|
$
|
422,000
|
$
|
60,0000
|
14.2
|
%
|
|||||
Other
general and administrative expense
|
$
|
1,485,000
|
$
|
1,175,000
|
$
|
310,000
|
26.4
|
%
|
|||||
Total
general and administrative expense
|
$
|
1,967,000
|
$
|
1,597,000
|
$
|
370,000
|
23.2
|
%
|
|||||
Other
income
|
$
|
60,000
|
$
|
185,000
|
$
|
(125,000
|
)
|
(67.6
|
)%
|
||||
Net
loss
|
$
|
7,458,000
|
$
|
4,669,000
|
$
|
2,789,000
|
59.7
|
%
|
During
each of the six months ended June 30, 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 June 30, 2008, if at all.
For
the
six months ended June 30, 2007 total research and development expense
was
$5,551,000 as compared to $3,257,000 for the six months ended June 30,
2006. The
increase of $2,294,000, or 70.4% is primarily comprised of an increase
of
$1,553,000 in in-license and associated fees, an increase of $740,000
in
clinical activities of Oleoyl-estrone and an increase in development
costs for
Altoderm, Altolyn and Hedrin of $251,000, partially offset by decreases
in
development costs for PTH of $253,000 and for Propofol of $25,000 .
For
the
six months ended June 30, 2007, total general and administrative expense
was
$1,967,000 as compared to $1,597,000 for the six months ended June 30,
2006. The
increase of $370,000, or 23.2%, is primarily due to increases of $60,000
in
stock based compensation, of $107,000 in spending on business development
activities, of $82,000 in payroll and related costs, of $63,000 in director
compensation costs, of $35,000 in insurance costs and of $30,000 in office
expenses.
For
the
six months ended June 30, 2007, other income was $60,000 as compared
to $185,000
for the six months ended June 30, 2006. The decrease of $125,000, or
67.6%, is
due primarily to a decrease in interest income which resulted from lower
average
balances in interest bearing cash and short-term investment
accounts.
Net
loss
for the six months ended June 30, 2007, was $7,458,000 as compared to
$4,669,000
for the six months ended June 30, 2006. The increase of $2,789,000, or
59.7%, in
net loss is attributable to an increase in research and development expense
of
$2,294,000, an increase in general and administrative expense of $370,000
and a
decrease in other income of $125,000.
18
THREE-MONTH
PERIOD ENDED JUNE 30, 2007 VS 2006
Quarter
ended June 30, 2007 |
Quarter
ended June 30, 2006 |
Increase
(decrease) |
% Increase
(decrease) |
||||||||||
Costs
and expenses
|
|||||||||||||
Research
and development
|
|||||||||||||
Stock
based compensation
|
$
|
122,000
|
$
|
83,000
|
$
|
39,000
|
47.0
|
%
|
|||||
In-license
and related fees
|
$
|
1,803,000
|
$
|
250,000
|
$
|
1,553,000
|
621.2
|
%
|
|||||
Other
research and development expense
|
$
|
1,947,000
|
$
|
1,238,000
|
$
|
709,000
|
57.3
|
%
|
|||||
Total
research and development expense
|
$
|
3,872,000
|
$
|
1,571,000
|
$
|
2,301,000
|
146.5
|
%
|
|||||
General
and administrative
|
|||||||||||||
Stock
based compensation
|
$
|
250,000
|
$
|
224,000
|
$
|
26,000
|
11.6
|
%
|
|||||
Other
general and administrative expense
|
$
|
802,000
|
$
|
562,000
|
$
|
240,000
|
42.7
|
%
|
|||||
Total
general and administrative expense
|
$
|
1,052,000
|
$
|
786,000
|
$
|
266,000
|
33.8
|
%
|
|||||
Other
income
|
$
|
30,000
|
$
|
86,000
|
$
|
(56,000
|
)
|
(65.1
|
)%
|
||||
Net
loss
|
$
|
4,894,000
|
$
|
2,271,000
|
$
|
2,623,000
|
115.5
|
%
|
During
each of the quarters ended June 30, 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 June 30, 2008, if at all.
For
the
quarter ended June 30, 2007 total research and development expense was
$3,872,000 as compared to $1,571,000 for the quarter ended June 30, 2006.
The
increase of $2,301,000, or 146.5%, is primarily attributable to a $1,553,000
increase in in-license and associated fees, an increase of $174,000 in
clinical
activities of Oleoyl-estrone, an increase of $318,000 in development
costs for
PTH and an increase in development costs for Altoderm, Altolyn and Hedrin
of
$251,000, partially offset by a decreases in development costs for Propofol
of
$20,000.
For
the
three months ended June 30, 2007, total general and administrative expense
was
$1,052,000 as compared to $786,000 for the three months ended June 30,
2006. The
increase of $266,000, or 33.8%, is primarily due to increases of $26,000
in
stock based compensation, of $63,000 in spending on business development
activities, of $33,000 in payroll and related costs, of $36,000 in director
compensation costs, of $26,000 in insurance costs, of $42,000 in professional
fees and of $22,000 in investor relations costs.
For
the
three months ended June 30, 2007, other income was $30,000 as compared
to
$86,000 for the three months ended June 30, 2006. The decrease of $56,000,
or
65.1%, is due primarily to a decrease in interest income which resulted
from
lower average balances in interest bearing cash and short-term investment
accounts.
Net
loss
for the three months ended June 30, 2007, was $4,894,000 as compared
to
$2,271,000 for the three months ended June 30, 2006. The increase of
$2,623,000,
or 115.5%, in net loss is attributable to an increase in research and
development expense of $2,301,000, an increase in general and administrative
expense of $266,000 and a decrease in other income of $56,000.
19
LIQUIDITY
AND CAPITAL RESOURCES
From
inception to June 30, 2007, we incurred a deficit during the development
stage
of $50.4 million primarily as a result of our net losses and preferred
stock
dividends. We expect to continue to incur additional losses through at
least
June 30, 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
six months
ended June 30, 2007, we had a net increase in cash and cash equivalents
of $1.8
million. This increase resulted largely from net proceeds related to
the sale of
common stock of $7.9 million partially offset by net cash used in operating
activities of $6.1 million. Total liquid resources as of June 30, 2007
were $4.8
million compared to $3.0 million at December 31, 2006.
Liquidity
As
of
June 30, 2007, we had working capital of $2.6 million compared to $1.4
million
at December 31, 2006. This $1.2 million increase in working capital is
primarily
due to net proceeds related to the sale of common stock of approximately
$7.9
million offset by net cash used in operating activities of $6.1 million
during
the six months ended June 30, 2007 and an increase in accounts payable
and
accrued expenses of $0.6 million.
March
2007 Private Placement
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 $7.9 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 filed 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 May 9, 2007,
which was
declared effective by the Securities and Exchange Commission on May 18,
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.
Commitments
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.
20
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.
Expenses
associated with the recently concluded clinical trials in common obesity
and
morbid obesity were recognized on this activity based basis. At June
30, 2007 we
recognized prepaid expense of $9,000 and accrued expenses of $267,000
related to
these clinical trials. The remaining financial commitments for these
clinical
trials are negligible.
Capital
Resources
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
June 30, 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 June 30, 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 our 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.
21
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.
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.
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.
22
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 $3,676,000 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, $961,000 of which was incurred in
the first
six 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.
To
date,
we have incurred $681,000 of project costs related to our development
of
Altoderm, all of which was incurred in the first six months of 2007.
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.
To
date,
we have incurred $526,000 of project costs related to our development
of
Altolyn, all of which was incurred in the first six months of 2007.
Hedrin
In
June
2007, we entered into an exclusive license agreement for Hedrin with
T&R and
Kerris, S.A. (“Kerris”). We previously entered into exclusive license agreements
with T&R with respect to two other products, Altoderm and Altolyn, with
respect to rights in North America. We acquired an exclusive North American
license to certain patent rights and other intellectual property relating
to
Hedrin(TM), a non-insecticide product candidate for the treatment of
head lice.
In addition, and at the same time, we also entered into a Supply Agreement
with
T&R pursuant to which T&R will be the Company’s exclusive supplier of
Hedrin product.
23
To
date,
we have incurred $872,000 of project costs related to our development
of Hedrin,
all of which was incurred in the first six months of 2007.
Oleoyl-estrone
On
July
9, 2007 we announced the results of our two Phase 2a clinical trials
of oral
Oleoyl-estrone. The results of both randomized, double-blind, placebo
controlled
studies, one in common obesity and the other in morbid obesity, demonstrated
no
statistically or clinically meaningful placebo adjusted weight loss for
any of
the treatment arms evaluated. Based on these results, we will discontinue
our
Oleoyl-estrone programs in both common obesity and morbid obesity.
To
date,
we have incurred $14,784,000 of project costs related to our development
of
Oleoyl-estrone, including milestone payments triggered under our license
agreement for Oleoyl-estrone, of which $2,499,000 was incurred in the
first six
months of 2007.
Lingual
spray propofol
On
July
9, 2007 we announced that we will discontinue development and we intend
to
pursue appropriate out-licensing opportunities for Propofol Lingual Spray
for
pre-procedural sedation.
To
date,
we have incurred $2,966,000 of project costs related to our development
of
propofol lingual spray, of which $12,000 was incurred in the first six
months of
2007.
Off-Balance
Sheet Arrangements
We
have
not entered into any off-balance sheet arrangements.
New
Accounting Pronouncements
In
March
2007, the FASB issued FASB Staff Position EITF 07-03 (“FSP 07-03”), Accounting
for Nonrefundable Advance Payments for Goods or Services to Be Used in
Future
Research and Development Activities. FSP 07-03 addresses whether nonrefundable
advance payments for goods or services that will be used or rendered
for
research and development activities should be expensed when the advance
payment
is made or when the research and development activity has been performed.
FSP
07-03 will be effective for fiscal years beginning after December 15, 2007,
and interim periods within those fiscal years. We currently believe that
the
adoption of FSP 07-03 will have no material impact on our financial position
or
results of operations.
24
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 June 30, 2007, and we have never held such
instruments in the past.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
As
of
June 30, 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 June 30, 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.
25
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
4. Submission of matters to a vote of security holders.
We
held
our Annual Meeting of Stockholders at the American Stock Exchange, 86
Trinity
Place, New York, New York on May 24, 2007. The stockholders took the
following
actions:
(i) The
stockholders elected seven directors to serve until the next Annual Meeting
of
Stockholders. The stockholders present in person or by proxy cast the
following
numbers of votes in connection with the election of directors, resulting
in the
election of all nominees:
Nominee
|
Votes For
|
Votes Withheld
|
|||||
Douglas
Abel
|
35,536,892
|
65,132
|
|||||
Neil
Herskowitz
|
35,376,093
|
225,931
|
|||||
Malcolm
Hoenlein
|
35,518,495
|
83,529
|
|||||
Timothy
McInerney
|
35,538,692
|
63,332
|
|||||
Joan
Pons Gimbert
|
35,154,378
|
447,646
|
|||||
Richard
I. Steinhart
|
35,529,736
|
72,288
|
|||||
Michael
Weiser
|
34,493,245
|
1,108,779
|
(ii)
The stockholders ratified the amendment to our 2003 Stock Option
Plan increasing the number of shares available for issuance thereunder
from
7,400,000 to 10,400,000. 34,440,971 votes were cast for the proposal;
1,107,853
votes were cast against the proposal, shares representing 53,200 votes
abstained; and there were no broker non-votes.
(iii)
The stockholders ratified the appointment of J.H. Cohn LLP as our
independent registered public accounting firm for fiscal 2007. 35,519,099
votes
were cast for the proposal; 8,205 votes were cast against the proposal,
shares
representing 74,720 votes abstained; and there were no broker
non-votes.
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).
|
26
10.2
|
Form
of subscription agreement between the Company and investors
in the March
30, 2007 private placement (incorporated by reference to Exhibit
10.1 of
the Company’s Form 8-K filed April 5, 2007).
|
|
10.3
|
Exclusive
License Agreement for “Altoderm” between Thornton & Ross Ltd. and
Manhattan Pharmaceuticals, Inc. dated April 3, 2007.
|
|
10.4
|
Exclusive
License Agreement for “Altolyn” between Thornton & Ross Ltd. and
Manhattan Pharmaceuticals, Inc. dated April 3, 2007.
|
|
10.5
|
Exclusive
License Agreement for “Hedrin” between Thornton & Ross Ltd., Kerris,
S.A. and Manhattan Pharmaceuticals, Inc. dated June 26,
2007.
|
|
10.6
|
Supply
Agreement for “Hedrin” between Thornton & Ross Ltd. and Manhattan
Pharmaceuticals, Inc. dated June 26, 2007.
|
|
31.1
|
Certification
of Chief Executive Officer
|
|
31.2
|
Certification
of Chief Financial Officer
|
|
32.1
|
Certifications
of Chief Executive Officer and Chief Financial Officer pursuant
to Section
906 of the Sarbanes-Oxley Act of 2002.
|
27
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: August 14, 2007 | By: | /s/ Douglas Abel |
Douglas Abel |
||
President and Chief Executive Officer |
|
|
|
Date: August 14, 2007 | By: | /s/ Michael G. McGuinness |
Michael G. McGuinness |
||
Chief Financial Officer |
28
Index
to Exhibits Filed with this Report
Description
|
||
10.3
|
Exclusive License Agreement for “Altoderm” between Thornton & Ross Ltd. and Manhattan Pharmaceuticals, Inc. dated April 3, 2007. | |
|
||
10.4
|
Exclusive License Agreement for “Altolyn” between Thornton & Ross Ltd. and Manhattan Pharmaceuticals, Inc. dated April 3, 2007. | |
|
||
10.5
|
Exclusive License Agreement for “Hedrin” between Thornton & Ross Ltd., Kerris, S.A. and Manhattan Pharmaceuticals, Inc. dated June 26, 2007. | |
|
||
10.6
|
Supply Agreement for “Hedrin” between Thornton & Ross Ltd. and Manhattan Pharmaceuticals, Inc. dated June 26, 2007. | |
31.1
|
Certification
of Chief Executive Officer
|
|
Certification
of Chief Financial Officer
|
||
32.1
|
Certifications
of Chief Executive Officer and Chief Financial Officer pursuant
to Section
906 of the Sarbanes-Oxley Act of
2002.
|
29