TG THERAPEUTICS, INC. - Quarter Report: 2007 September (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 September 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
November 9, 2007 there were 70,624,232 shares of the issuer’s common stock,
$.001 par value, outstanding.
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
|
18
|
||
Item
3.
|
Quantitative
and Qualitative Disclosure About Market Risk
|
28
|
||
Item
4T.
|
Controls
and Procedures
|
28
|
||
PART
II
|
OTHER
INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
29
|
||
Item
1A.
|
Risk
Factors
|
29
|
||
Item
6.
|
Exhibits
|
29
|
||
Signatures
|
30
|
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
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
(A
Development Stage Company)
Condensed
Consolidated Balance Sheets
September
30,
|
December
31,
|
||||||
2007
|
2006
|
||||||
(Unaudited)
|
(See
Note 1)
|
||||||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
2,032,655
|
$
|
3,029,118
|
|||
Prepaid
expenses
|
202,161
|
264,586
|
|||||
Total
current assets
|
2,234,816
|
3,293,704
|
|||||
Property
and equipment, net
|
52,472
|
83,743
|
|||||
Other
assets
|
70,506
|
70,506
|
|||||
Total
assets
|
$
|
2,357,794
|
$
|
3,447,953
|
|||
Liabilities
and Stockholders’ Equity
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
852,490
|
$
|
1,393,296
|
|||
Accrued
expenses
|
938,656
|
550,029
|
|||||
Total
current liabilities
|
1,791,146
|
1,943,325
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders’
equity:
|
|||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares issued
and
outstanding at September 30, 2007 and December 31, 2006,
respectively
|
-
|
-
|
|||||
Common
stock, $.001 par value. Authorized 150,000,000 shares; 70,624,232
and
60,120,038 shares issued and outstanding at September 30, 2007 and
December 31, 2006, respectively
|
70,624
|
60,120
|
|||||
Additional
paid-in capital
|
53,590,920
|
44,411,326
|
|||||
Deficit
accumulated during the development stage
|
(53,094,896
|
)
|
(42,966,818
|
)
|
|||
Total
stockholders’ equity
|
566,648
|
1,504,628
|
|||||
Total
liabilities and stockholders' equity
|
$
|
2,357,794
|
$
|
3,447,953
|
See
accompanying notes to unaudited condensed consolidated financial
statements.
4
(A
Development Stage Company)
Condensed
Consolidated Statements of Operations
(Unaudited)
Three
Months
ended
September 30,
|
Nine
months
ended
September 30,
|
Cumulative
period from August 6, 2001 (inception) to September
30,
|
||||||||||||||
2007
|
2006
|
2007
|
2006
|
2007
|
||||||||||||
Revenue
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
—
|
||||||
Costs
and expenses:
|
||||||||||||||||
Research
and development
|
1,808,958
|
1,041,693
|
7,360,040
|
4,299,039
|
25,313,396
|
|||||||||||
General
and administrative
|
898,063
|
923,755
|
2,865,161
|
2,521,091
|
13,109,254
|
|||||||||||
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
|
2,707,021
|
1,965,448
|
10,225,201
|
6,820,130
|
52,772,565
|
|||||||||||
Operating
loss
|
(2,707,021
|
)
|
(1,965,448
|
)
|
(10,225,201
|
)
|
(6,820,130
|
)
|
(52,772,565
|
)
|
||||||
Other
(income) expense:
|
||||||||||||||||
Interest
and other income
|
(37,600
|
)
|
(68,740
|
)
|
(97,598
|
)
|
(253,929
|
)
|
(807,314
|
)
|
||||||
Interest
expense
|
-
|
714
|
475
|
952
|
26,033
|
|||||||||||
Realized
gain on sale of marketable equity securities
|
-
|
-
|
-
|
(490
|
)
|
(76,032
|
)
|
|||||||||
Total
other income
|
(37,600
|
)
|
(68,026
|
)
|
(97,123
|
)
|
(253,467
|
)
|
(857,313
|
)
|
||||||
Net
loss
|
(2,669,421
|
)
|
(1,897,422
|
)
|
(10,128,078
|
)
|
(6,566,663
|
)
|
(51,915,252
|
)
|
||||||
Preferred
stock dividends (including imputed amounts)
|
-
|
-
|
-
|
-
|
(1,179,644
|
)
|
||||||||||
Net
loss applicable to common shares
|
$
|
(2,669,421
|
)
|
$
|
(1,897,422
|
)
|
$
|
(10,128,078
|
)
|
$
|
(6,566,663
|
)
|
$
|
(53,094,896
|
)
|
|
Net
loss per common share:
|
||||||||||||||||
Basic
and diluted
|
$
|
(0.04
|
)
|
$
|
(0.03
|
)
|
$
|
(0.15
|
)
|
$
|
(0.11
|
)
|
||||
Weighted
average shares of common stock outstanding:
|
||||||||||||||||
Basic
and diluted
|
70,591,623
|
60,120,038
|
67,134,882
|
60,109,737
|
See
accompanying notes to unaudited condensed consolidated financial
statements.
5
(A
Development Stage Company)
Condensed
Consolidated Statement of Stockholders' Equity (Deficiency)
(Unaudited)
|
|
Series
A
convertible preferred stock |
|
Common
stock
|
|
Additional
paid-in capital
|
|
Subscription
receivable
|
|
Deficit
accumulated during development
stage
|
|
payable
in Series A preferred
shares
|
|
Accumulated
other comprehensive
income
(loss)
|
|
Unearned
consulting
services
|
|
Total
stock- holders'equity
(deficiency)
|
|
|||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
|||||||||||||||||||
Stock
issued at $0.0004 per share for subscription
receivable
|
—
|
$
|
—
|
10,167,741
|
$
|
10,168
|
$
|
(6,168
|
)
|
$
|
(4,000
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(56,796
|
)
|
—
|
—
|
—
|
(56,796
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2001
|
—
|
—
|
10,167,741
|
10,168
|
(6,168
|
)
|
(4,000
|
)
|
(56,796
|
)
|
—
|
—
|
—
|
(56,796
|
)
|
|||||||||||||||||||
Proceeds
from subscription receivable
|
—
|
—
|
—
|
—
|
—
|
4,000
|
—
|
—
|
—
|
—
|
4,000
|
|||||||||||||||||||||||
Stock
issued at $0.0004 per share for license rights
|
—
|
—
|
2,541,935
|
2,542
|
(1,542
|
)
|
—
|
—
|
—
|
—
|
—
|
1,000
|
||||||||||||||||||||||
Stock
options issued for consulting services
|
—
|
—
|
—
|
—
|
60,589
|
—
|
—
|
—
|
—
|
(60,589
|
)
|
—
|
||||||||||||||||||||||
Amortization
of unearned consulting services
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
22,721
|
22,721
|
|||||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
—
|
—
|
3,043,332
|
3,043
|
1,701,275
|
—
|
—
|
—
|
—
|
—
|
1,704,318
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
(1,037,320
|
)
|
—
|
—
|
—
|
(1,037,320
|
)
|
||||||||||||||||||||||
Balance
at December 31, 2002
|
—
|
—
|
15,753,008
|
15,753
|
1,754,154
|
—
|
(1,094,116
|
)
|
—
|
—
|
(37,868
|
)
|
637,923
|
|||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
—
|
—
|
1,321,806
|
1,322
|
742,369
|
—
|
—
|
—
|
—
|
—
|
743,691
|
|||||||||||||||||||||||
Effect
of reverse acquisition
|
—
|
—
|
6,287,582
|
6,287
|
2,329,954
|
—
|
—
|
—
|
—
|
—
|
2,336,241
|
|||||||||||||||||||||||
Amortization
of unearned consulting costs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
37,868
|
37,868
|
|||||||||||||||||||||||
Unrealized
loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(7,760
|
)
|
—
|
(7,760
|
)
|
|||||||||||||||||||||
Payment
for fractional shares for stock combination
|
—
|
—
|
—
|
—
|
(300
|
)
|
—
|
—
|
—
|
—
|
—
|
(300
|
)
|
|||||||||||||||||||||
Preferred
stock issued at $10 per share, net of expenses
|
1,000,000
|
1,000
|
—
|
—
|
9,045,176
|
—
|
—
|
—
|
—
|
—
|
9,046,176
|
|||||||||||||||||||||||
Imputed
preferred stock dividend
|
418,182
|
—
|
(418,182
|
)
|
—
|
—
|
||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,960,907
|
)
|
—
|
—
|
—
|
(5,960,907
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2003
|
1,000,000
|
1,000
|
23,362,396
|
23,362
|
14,289,535
|
—
|
(7,473,205
|
)
|
—
|
(7,760
|
)
|
—
|
6,832,932
|
|||||||||||||||||||||
Exercise
of stock options
|
—
|
—
|
27,600
|
27
|
30,073
|
—
|
—
|
—
|
—
|
—
|
30,100
|
|||||||||||||||||||||||
Common
stock issued at $1.10, net of expenses
|
—
|
—
|
3,368,952
|
3,369
|
3,358,349
|
—
|
—
|
—
|
—
|
—
|
3,361,718
|
|||||||||||||||||||||||
Preferred
stock dividend accrued
|
—
|
—
|
—
|
—
|
—
|
—
|
(585,799
|
)
|
585,799
|
—
|
—
|
—
|
||||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
24,901
|
25
|
—
|
—
|
281,073
|
—
|
—
|
(282,388
|
)
|
—
|
—
|
(1,290
|
)
|
|||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(170,528
|
)
|
(171
|
)
|
1,550,239
|
1,551
|
(1,380
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
Warrants
issued for consulting services
|
—
|
—
|
—
|
—
|
125,558
|
—
|
—
|
—
|
—
|
(120,968
|
)
|
4,590
|
||||||||||||||||||||||
Amortization
of unearned consulting costs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100,800
|
100,800
|
|||||||||||||||||||||||
Unrealized
gain on short-term investments and reversal of unrealized loss
on
short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20,997
|
—
|
20,997
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,896,031
|
)
|
—
|
—
|
—
|
(5,896,031
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2004
|
854,373
|
854
|
28,309,187
|
28,309
|
18,083,208
|
—
|
(13,955,035
|
)
|
303,411
|
13,237
|
(20,168
|
)
|
4,453,816
|
|||||||||||||||||||||
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
|
7,841,999
|
—
|
—
|
—
|
—
|
—
|
7,852,185
|
|||||||||||||||||||||||
Common
stock issued to directors at $0.72 per share in satisfaction
of accounts
payable
|
—
|
—
|
27,776
|
28
|
19,972
|
—
|
—
|
—
|
—
|
20,000
|
||||||||||||||||||||||||
Common
stock issued in connection with in-licensing agreement at $0.90
per
share
|
—
|
—
|
125,000
|
125
|
112,375
|
—
|
—
|
—
|
—
|
—
|
112,500
|
|||||||||||||||||||||||
Common
stock issued in connection with in-licensing agreement at
$0.80 per
share
|
—
|
—
|
150,000
|
150
|
119,850
|
—
|
—
|
—
|
—
|
—
|
120,000
|
|||||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
1,078,185
|
—
|
—
|
—
|
—
|
—
|
1,078,185
|
|||||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
10,327
|
15
|
7,219
|
—
|
—
|
—
|
—
|
—
|
7,234
|
|||||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
5,589
|
—
|
(6
|
)
|
—
|
—
|
—
|
—
|
—
|
(6
|
)
|
|||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
-
|
—
|
(10,128,078
|
)
|
—
|
—
|
—
|
(10,128,078
|
)
|
|||||||||||||||||||||
Balance
at September 30, 2007
|
—
|
$
|
—
|
70,624,232
|
$
|
70,624
|
$
|
53,590,920
|
$
|
—
|
$
|
(53,094,896
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
566,648
|
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
|
||||||||||
Nine
months
ended
|
(inception)
to
|
|||||||||
September
30,
|
September
30,
|
|||||||||
2007
|
2006
|
2007
|
||||||||
|
||||||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(10,128,078
|
)
|
$
|
(6,566,663
|
)
|
$
|
(51,915,252
|
)
|
|
Adjustments
to reconcile net loss to
|
||||||||||
net
cash used in operating activities:
|
||||||||||
Share-based
compensation
|
1,078,185
|
945,858
|
3,002,212
|
|||||||
Shares
issued in connection with in-licensing agreements
|
232,500
|
-
|
232,500
|
|||||||
Amortization
of intangible assets
|
-
|
-
|
145,162
|
|||||||
Gain
on sale of marketable equity securities
|
-
|
(490
|
)
|
(76,032
|
)
|
|||||
Depreciation
|
40,406
|
44,581
|
187,886
|
|||||||
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
|
62,425
|
(554,274
|
)
|
(143,916
|
)
|
|||||
Increase
in other assets
|
-
|
-
|
(70,506
|
)
|
||||||
Increase/(decrease)
in accounts payable
|
(520,806
|
)
|
(531,941
|
)
|
1,272,704
|
|||||
Increase
in accrued expenses
|
388,627
|
280,405
|
398,335
|
|||||||
Net
cash used in operating activities
|
(8,846,741
|
)
|
(6,382,524
|
)
|
(32,777,586
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchase
of property and equipment
|
(9,135
|
)
|
(15,872
|
)
|
(230,636
|
)
|
||||
Cash
paid in connection with acquisitions, net
|
-
|
-
|
(26,031
|
)
|
||||||
Proceeds
from sale of short-term investments, net
|
-
|
500,000
|
435,938
|
|||||||
Proceeds
from sale of license
|
-
|
-
|
200,001
|
|||||||
Net
cash (used in) provided by investing activities
|
(9,135
|
)
|
484,128
|
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
|
7,852,185
|
(15,256
|
)
|
25,896,262
|
||||||
Proceeds
from sale of preferred stock, net
|
-
|
-
|
9,046,176
|
|||||||
Proceeds
from exercise of warrants and stock options
|
7,228
|
-
|
138,219
|
|||||||
Other,
net
|
-
|
-
|
237,500
|
|||||||
Net
cash provided by (used in) financing activities
|
7,859,413
|
(15,256
|
)
|
34,430,969
|
||||||
Net
(decrease) increase in cash and cash equivalents
|
(996,463
|
)
|
(5,913,652
|
)
|
2,032,655
|
|||||
Cash
and cash equivalents at beginning of period
|
3,029,118
|
9,826,336
|
—
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
2,032,655
|
$
|
3,912,684
|
$
|
2,032,655
|
||||
Supplemental
disclosure of cash flow information:
|
||||||||||
Interest
paid
|
$
|
475
|
$
|
952
|
$
|
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 agreements
|
232,500
|
-
|
232,500
|
|||||||
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 nine month periods ended September 30, 2007.
As
of
September 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 $10,128,078 and negative cash flows from
operating activities of $8,866,741 for the nine months ended September 30,
2007.
The net loss from date of inception, August 6, 2001, to September 30, 2007
amounts to $51,915,252.
Management
believes that the Company will continue to incur net losses through at least
September 30, 2008, and for the foreseeable future thereafter. Based on the
resources of the Company available at September 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 13,422,729 as of September 30, 2007 and
2006,
respectively.
9
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(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 nine month periods ending September 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.
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 $371,636 and $326,730 for the three month periods ended
September 30, 2007 and 2006 respectively, and $1,078,185 and $945,858 for the
nine month periods ended September 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 September 30, 2007 and 2006, net of
amortization, the Company recognized share-based compensation cost (credits)
of
$(8,767) and $(6,775), for the three month periods ended September 30, 2007
and
2006, respectively, and $(5,212) and $(33,096) for the nine month periods ended
September 30, 2007 and 2006, respectively.
10
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
The
Company has allocated share-based compensation costs and credits to general
and
administrative and research and development expenses as follows:
Three
months ended September 30,
|
Nine
months ended
September 30, |
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
General
and administrative expense:
|
|||||||||||||
Share-based
employee compensation costs
|
$
|
254,870
|
$
|
225,394
|
$
|
726,414
|
$
|
670,371
|
|||||
Share-based
consultant and non-employee (credits) costs
|
—
|
(2,962
|
)
|
10,550
|
(25,823
|
)
|
|||||||
Total
general and administrative expense
|
$
|
254,870
|
$
|
222,432
|
$
|
736,964
|
$
|
644,548
|
|||||
Research
and development expense:
|
|||||||||||||
Share-based
employee compensation costs
|
$
|
125,533
|
$
|
108,111
|
$
|
356,983
|
$
|
308,583
|
|||||
Share-based
consultant and non-employee (credits) costs
|
(8,767
|
)
|
(3,813
|
)
|
(15,762
|
)
|
(7,273
|
)
|
|||||
Total
research and development expense
|
$
|
116,766
|
$
|
104,298
|
$
|
341,221
|
$
|
301,310
|
|||||
Total
share-based costs
|
$
|
371,636
|
$
|
326,730
|
$
|
1,078,185
|
$
|
945,858
|
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 data related to 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 permitted by 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 September 30,
|
Nine
months ended September 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Expected
Volatility
|
93
|
%
|
55
|
%
|
80%
- 93
|
%
|
55
|
%
|
|||||
Dividend
yield
|
—
|
—
|
—
|
—
|
|||||||||
Expected
term (in years)
|
6
- 8
|
6
|
6
- 8
|
6
|
|||||||||
Risk-free
interest rate
|
4.38%
- 4.96
|
%
|
4.88
|
%
|
4.38%
- 4.96
|
%
|
4.88
|
%
|
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 common 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
September 30, 2007, under the 2003 Plan, 10,400,000 shares of common stock
were
authorized for issuance. At September 30, 2007, under the 2003 Plan, options
to
purchase 7,096,598 shares of common stock were outstanding. In addition, 27,776
shares of common stock were issued under the 2003 Plan leaving 3,275,626 shares
of common stock reserved for future stock option grants as of September 30,
2007. 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 nine months ended September 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 of shares
reserved for stock option grants. In June 2005, the 1995 Plan expired and no
further options can be granted. As of September 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.
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 September 30,
2007 and changes during the nine months then ended is presented
below:
Weighted
|
|||||||||||||
Weighted
|
Average
|
||||||||||||
average
|
Remaining
|
Aggregate
|
|||||||||||
exercise
|
Contractual
|
Intrinsic
|
|||||||||||
Shares
|
price
|
Term
(years)
|
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
|
|||||||||||||
September
30, 2007
|
8,233,838
|
$
|
1.25
|
7.19
|
$
|
-
|
|||||||
Options
exercisable at
|
|||||||||||||
September
30, 2007
|
5,247,546
|
$
|
1.29
|
6.74
|
$
|
-
|
|||||||
Weighted-average
fair value of options granted during the nine months ended
September 30,
2007
|
$
|
0.63
|
As
of
September 30, 2007, the total compensation cost related to non-vested option
awards not yet recognized is $1,039,009. The weighted average period over which
it is expected to be recognized is approximately 0.9 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 the 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
AND CONTINGENCIES
Research
and development contracts
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 method. At
September 30, 2007 there are no remaining financial commitments for these
clinical trials.
The
Company is developing PTH (1-34) as a topical treatment for psoriasis. Expenses
associated with the manufacture of clinical and non-clinical supplies of PTH
(1-34) are recognized on this activity based method. At September 30, 2007
we
recognized prepaid expense of $30,000 and accrued expenses of $100,135. The
remaining financial commitment related to the manufacture of PTH (1-34) is
negligible.
During
the three months ended September 30, 2007 we entered into an agreement with
Therapeutics, Inc. for the conduct of a clinical trial of PTH (1-34). The total
amount payable under the agreement is approximately $845,000. At September
30,
2007 we recognized research and development expense and accrued expenses of
approximately $60,000. The remaining financial commitment related to the conduct
of the clinical trial is approximately $785,000. This clinical trial is expected
to conclude in the second quarter of 2008.
Swiss
Pharma Contract LTD
Swiss
Pharma Contract LTD (“Swiss Pharma”), a clinical site that the Company used in
one of its obesity trials, gave notice to the Company that Swiss Pharma believes
it is entitled to receive an additional payment of $322,776 for services in
connection with that clinical trial. While the contract between the Company
and
Swiss Pharma provides for additional payments if certain conditions are met,
Swiss Parma has not specified which conditions they believe have been achieved
and the Company does not believe that Swiss Pharma is entitled to additional
payments and has not accrued any of these costs as of September 30, 2007. The
contract between the Company and Swiss Pharma provides for arbitration in the
event of a dispute, such as this claim for an additional payment. Swiss Pharma
has filed a demand for arbitration. As the Company does not believe that Swiss
Pharma is entitled to additional payments, it intends to defend its position
in
arbitration.
14
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Contentions
of a former employee
In
February 2007, a former employee of the Company alleged an ownership interest
in
two of the Company’s provisional patent applications covering our discontinued
product development program for Oleoyl-estrone. Also, without articulating
precise legal claims, the former employee contends that the Company wrongfully
characterized the former employee’s separation from employment as a resignation
instead of a dismissal in an effort to harm the former employee’s immigration
sponsorship efforts, and, further, to wrongfully deprive the former employee
of
the former employee’s alleged rights in two of the Company’s provisional patent
applications. The former employee is seeking an unspecified amount in
damages. The Company refutes the former employee’s contentions and intends to
vigorously defend itself should the former employee file claims against the
Company. There have been no further developments with respect to these
contentions.
(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. Gross and net proceeds from the private placement were $8,559,155 and
$7,852,185, respectively.
Pursuant
to these subscription agreements the Company filed a registration statement
on
Form S-3 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. (“Paramont”),
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.
15
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(7) 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
expense. 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% of 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 expense. 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.
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.
16
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
In
consideration for the license, the Company issued to T&R and Kerris
(jointly, the “Licensor”) a combined total of 150,000 shares of its common stock
valued at $120,000. In addition, the Company also made a cash payment of
$600,000 to the Licensor. These amounts are included in research and development
expense. 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. 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.
(8) RECENTLY
DISCONTINUED PRODUCT DEVELOPMENT PROGRAMS
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.
17
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 nine month periods ended September 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.
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 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;
|
·
|
Hedrin,
a novel, non-insecticide treatment for head
lice;
|
·
|
and
Altolyn, a proprietary site specific tablet formulation of oral cromolyn
sodium for the treatment of
mastocytosis.
|
We
have
not received regulatory approval for, or generated commercial revenues from
marketing or selling any drugs.
We
announced in July 2007 that we are discontinuing development of two product
candidates, oral Oleoyl-estrone (“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.
18
RESULTS
OF OPERATIONS
NINE-MONTH
PERIOD ENDED SEPTEMBER 30, 2007 VS
2006
Nine
months ended September
30,
|
Increase
|
%
Increase
|
|||||||||||
2007
|
2006
|
(decrease)
|
(decrease)
|
||||||||||
Costs
and expenses
|
|||||||||||||
Research
and development
|
|||||||||||||
Stock
based compensation
|
$
|
341,000
|
$
|
301,000
|
$
|
40,000
|
13.3
|
%
|
|||||
In-license
and related fees
|
$
|
1,804,000
|
$
|
250,000
|
$
|
1,554,000
|
621.6
|
%
|
|||||
Consulting
costs related to in-license activities
|
$
|
134,000
|
$
|
-
|
$
|
134,000
|
N/A
|
||||||
Other
research and development expense
|
$
|
5,081,000
|
$
|
3,748,000
|
$
|
1,333,000
|
35.6
|
%
|
|||||
Total
research and development expense
|
$
|
7,360,000
|
$
|
4,299,000
|
$
|
3,061,000
|
71.2
|
%
|
|||||
General
and administrative
|
|||||||||||||
Stock
based compensation
|
$
|
737,000
|
$
|
645,000
|
$
|
92,000
|
14.3
|
%
|
|||||
Other
general and administrative expense
|
$
|
2,128,000
|
$
|
1,876,000
|
$
|
252,000
|
13.4
|
%
|
|||||
Total
general and administrative expense
|
$
|
2,865,000
|
$
|
2,521,000
|
$
|
344,000
|
13.6
|
%
|
|||||
Other
income
|
$
|
97,000
|
$
|
253,000
|
$
|
(156,000
|
)
|
-61.7
|
%
|
||||
Net
loss
|
$
|
(10,128,000
|
)
|
$
|
(6,567,000
|
)
|
$
|
3,561,000
|
54.2
|
%
|
During
each of the nine months ended September 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 September 30, 2008, if at
all.
For
the
nine months ended September 30, 2007 total research and development expense
was
$7,360,000 as compared to $4,299,000 for the nine months ended September 30,
2006. The increase of $3,061,000, or 71.2% is primarily comprised of an increase
of $1,804,000 in in-license and associated fees, an increase in consulting
costs
related to in-license activities of $134,000, an increase of $40,000 in stock
based compensation, an increase of $446,000 in development costs for PTH, an
increase in development costs for Altoderm, Altolyn and Hedrin of $424,000
and
an increase of $514,000 in clinical activities of Oleoyl-estrone, partially
offset by decreases in development costs for Propofol of $51,000. Research
and
development expense for the nine months ended September 30, 2007 includes
non-cash costs of $657,000, comprised of $233,000 of in-license fees paid in
common stock, $84,000 of consulting costs related to in-license activities
paid
in warrants to purchase common stock and $341,000 in stock based compensation.
By comparison research and development costs for the nine months ended September
30, 2006 includes non-cash costs of $301,000, comprised entirely of stock based
compensation.
For
the
nine months ended September 30, 2007, total general and administrative expense
was $2,865,000 as compared to $2,521,000 for the nine months ended September
30,
2006. The increase of $344,000, or 13.6%, is primarily due to increases of
$92,000 in stock based compensation, of $79,000 in spending on business
development activities, of $71,000 in payroll and related costs, of $88,000
in
director compensation costs and of $31,000 in professional fees.
For
the
nine months ended September 30, 2007, other income was $97,000 as compared
to
$253,000 for the nine months ended September 30, 2006. The decrease of $156,000,
or 61.7%, is due primarily to a decrease in interest income which resulted
from
lower average balances in interest bearing cash and short-term investment
accounts.
19
Net
loss
for the nine months ended September 30, 2007 was $10,128,000 as compared to
$6,567,000 for the nine months ended September 30, 2006. The increase of
$3,561,000, or 54.2%, in net loss is principally attributable to an increase
in
in-license and related fees of $1,804,000, increases in spending on research
and
development programs of $1,333,000, an increase in general and administrative
expense of $344,000 and a decrease in other income of $156,000.
THREE-MONTH
PERIOD ENDED SEPTEMBER 30, 2007 VS 2006
Quarter
ended September 30,
|
|
Increase
|
|
%
Increase
|
|
||||||||
|
|
2007
|
|
2006
|
|
(decrease)
|
|
(decrease)
|
|||||
Costs
and expenses
|
|||||||||||||
Research
and development
|
|||||||||||||
Stock
based compensation
|
$
|
117,000
|
$
|
104,000
|
$
|
13,000
|
12.5
|
%
|
|||||
Other
research and development expense
|
$
|
1,692,000
|
$
|
938,000
|
$
|
754,000
|
80.4
|
%
|
|||||
Total
research and development expense
|
$
|
1,809,000
|
$
|
1,042,000
|
$
|
767,000
|
73.6
|
%
|
|||||
General
and administrative
|
|||||||||||||
Stock
based compensation
|
$
|
255,000
|
$
|
222,000
|
$
|
33,000
|
14.9
|
%
|
|||||
Other
general and administrative expense
|
$
|
643,000
|
$
|
702,000
|
$
|
(59,000
|
)
|
-8.4
|
%
|
||||
Total
general and administrative expense
|
$
|
898,000
|
$
|
924,000
|
$
|
(26,000
|
)
|
-2.8
|
%
|
||||
Other
income
|
$
|
37,000
|
$
|
68,000
|
$
|
(31,000
|
)
|
-45.6
|
%
|
||||
Net
loss
|
$
|
(2,670,000
|
)
|
$
|
(1,898,000
|
)
|
$
|
772,000
|
40.7
|
%
|
During
each of the quarters ended September 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 September 30, 2008, if at
all.
For
the
quarter ended September 30, 2007 total research and development expense was
$1,809,000 as compared to $1,042,000 for the quarter ended September 30, 2006.
The increase of $767,000, or 73.6%, is primarily attributable to an increase
of
$699,000 in development costs for PTH, an increase in development costs for
Altoderm, Altolyn and Hedrin of $307,000 and an increase in stock based
compensation of $13,000 partially offset by decreases in development costs
for
Oleoyl-estrone and Propofol of $252,000.
For
the
three months ended September 30, 2007, total general and administrative expense
was $898,000 as compared to $924,000 for the three months ended September 30,
2006. The decrease of $26,000, or 2.8%, is primarily due to decreases of $23,000
in spending on business development activities, of $26,000 in payroll and
related costs, of $26,000 in insurance costs and of $16,000 in travel and
entertainment costs partially offset by increases of $33,000 in stock based
compensation, of $25,000 in directors’ fees and of $19,000 in professional
fess.
For
the
three months ended September 30, 2007, other income was $37,000 as compared
to
$68,000 for the three months ended September 30, 2006. The decrease of $31,000,
or 45.6%, is due primarily to a decrease in interest income which resulted
from
lower average balances in interest bearing cash and short-term investment
accounts.
20
Net
loss
for the three months ended September 30, 2007 was $2,670,000 as compared to
$1,898,000 for the three months ended September 30, 2006. The increase of
$772,000, or 40.7%, in net loss is principally attributable to an increase
in
research and development expense of $767,000, a decrease in general and
administrative expense of $26,000 and a decrease in other income of
$31,000.
LIQUIDITY
AND CAPITAL RESOURCES
From
inception to September 30, 2007, we incurred a deficit during the development
stage of $53.1 million primarily as a result of our net losses and preferred
stock dividends. We expect to continue to incur additional losses through at
least September 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 nine
months ended September 30, 2007, we had a net decrease in cash and cash
equivalents of $1.0 million. This decrease resulted principally from net cash
used in operating activities of $8.8 million partially offset by net proceeds
received from the sale of common stock of $7.9 million. Total liquid resources
as of September 30, 2007 were $2.0 million compared to $3.0 million at December
31, 2006.
Liquidity
As
of
September 30, 2007, we had working capital of $0.4 million compared to $1.4
million at December 31, 2006. This $1.0 million decrease in working capital
is
primarily due to net cash used in operating activities of $8.8 million partially
offset by net proceeds received from the sale of common stock of approximately
$7.9 million offset.
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. (“Paramount”), 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.
21
Commitments
and Contingencies
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.
Expenses
associated with the recently concluded clinical trials in common obesity and
morbid obesity were recognized on this activity based basis. At September 30,
2007 we recognized prepaid expense of $14,000 and accrued expenses of $140,000
related to these clinical trials. There are no remaining financial commitments
for these clinical trials.
The
Company is developing PTH (1-34) as a topical treatment for psoriasis. Expenses
associated with the manufacture of clinical and non-clinical supplies of PTH
(1-34) are recognized on this activity based method. At September 30, 2007
we
recognized prepaid expense of $30,000 and accrued expenses of $100,135. The
remaining financial commitment related to the manufacture of PTH (1-34) is
negligible.
During
the three months ended September 30, 2007 we entered into an agreement
with Therapeutics, Inc. for the conduct of a clinical trial of PTH (1-34).
The
total amount payable under the agreement is approximately $845,000. At September
30, 2007 we recognized research and development expense and accrued expenses
of
approximately $60,000. The remaining financial commitment related to the conduct
of the clinical trial is approximately $785,000. This clinical trial is expected
to conclude in the second quarter of 2008.
Swiss
Pharma Contract LTD (“Swiss Pharma”), a clinical site that the Company used in
one of its obesity trials, gave notice to the Company that Swiss Pharma believes
it is entitled to receive an additional payment of $322,776 for services in
connection with that clinical trial. While the contract between the Company
and
Swiss Pharma provides for additional payments if certain conditions are met,
Swiss Parma has not specified which conditions they believe have been achieved
and the Company does not believe that Swiss Pharma is entitled to additional
payments and has not accrued any of these costs as of September 30, 2007. The
contract between the Company and Swiss Pharma provides for arbitration in the
event of a dispute, such as this claim for an additional payment. Swiss Pharma
has filed a demand for arbitration. As the Company does not believe that Swiss
Pharma is entitled to additional payments, it intends to defend its position
in
arbitration.
In
February 2007, a former employee of the Company alleged an ownership interest
in
two of the Company’s provisional patent applications covering our discontinued
product development program for Oleoyl-estrone. Also, without articulating
precise legal claims, the former employee contends that the Company wrongfully
characterized the former employee’s separation from employment as a resignation
instead of a dismissal in an effort to harm the former employee’s immigration
sponsorship efforts, and, further, to wrongfully deprive the former employee
of
the former employee’s alleged rights in two of the Company’s provisional patent
applications. The former employee is seeking an unspecified amount in
damages. The Company refutes the former employee’s contentions and intends to
vigorously defend itself should the former employee file claims against the
Company. There have been no further developments with respect to these
contentions.
22
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
September 30, 2007, substantially all 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 September 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
September 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 June 30, 2007, 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.
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 October 2007. 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.
23
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 I/II clinical trial evaluating the safety and efficacy of PTH
(1-34) as a topical treatment for psoriasis. This double-blind,
placebo-controlled trial in 15 patients compared the topical PTH (1-34)
formulation versus the 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 topical 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 Phase I/II trial with topical
PTH
(1-34), we believe that it may have an important clinical advantage over current
topical psoriasis treatments.
A
physician sponsored Investigational New Drug (IND) Phase 2a trial involving
PTH
(1-34) was initiated in December 2005, again under the auspices of Boston
University, but in April 2006 we reported a delay in this planned Phase 2a
clinical study due to a formulation issue. We have identified and resolved
this
issue, and a new formulation of topical PTH (1-34) has been
produced.
A
corporate IND application for the new formulation of topical PTH (1-34) was
accepted by the U.S. Food and Drug Administration (FDA) in September 2007.
In
October 2007, the company announced that it had initiated and begun dosing
in a
Phase 2a multi-center, randomized, double-blind, vehicle-controlled, parallel
group clinical study. This study will enroll and treat approximately 54 subjects
in a 1:1:1 randomization of two doses of topical PTH (1-34) compared to vehicle
for an eight week treatment period. The vehicle is the topical PTH (1-34)
product without the active ingredient, PTH (1-34).
24
To
date,
we have incurred $4,586,000 of project costs related to our development of
topical PTH (1-34). These project costs have been incurred since April 1, 2005,
the date of the Tarpan Therapeutics acquisition, $1,871,000 of which was
incurred in the first nine 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.”
In
a
previously completed Phase 3 randomized, double-blind, placebo-controlled,
parallel-group study, conducted in Europe by T&R, 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.
This
product candidate is currently being tested by T&R in a second, ongoing
Phase 3 clinical study in Europe. Analysis of the preliminary data from the
initial 12 week, blinded portion of this randomized, double-blind, vehicle
controlled clinical trial has been completed. In this study the vehicle was
the
Altoderm product without the active ingredient, cromolyn sodium.
Data
indicate that Altoderm was safe and well tolerated, and showed a trend toward
improvement in pruritus (itching), but the efficacy results were inconclusive.
Altoderm treated subjects and vehicle only treated subjects experienced a
similar improvement (each greater than 30%), and therefore, the study did not
achieve statistical significance. The Company believes these outcomes were
due
to a suboptimal study design where subjects were unrestricted in their use
of
concomitant therapies such as topical steroids and
immunomodulators.
The
data
obtained from these studies will be submitted in support of Altoderm to both
European and US regulatory agencies. Given the promising clinical data obtained
from the first European Phase 3 study, and the symptom improvements reported
in
the ongoing European Phase 3 study, both Manhattan Pharmaceuticals and Thornton
& Ross Limited believe there is significant potential for Altoderm and will
continue development of this product candidate. Manhattan Pharmaceuticals is
scheduled for a pre-IND meeting with the U.S. FDA in January 2008 and is
finalizing a pre-IND package in anticipation of that meeting. The Company
intends to pursue Altoderm as a Phase 2 product candidate with indications
in
pruritus associated with atopic dermatitis and other pruritic conditions. The
Company also expects Altoderm clinical studies to be required in the U.S. with
the first of these studies to commence in the first half of 2008.
To
date,
we have incurred $877,000 of project costs, including license fees of $587,000
of which $475,000 was paid in cash and $112,500 of which was satisfied through
the issuance of 125,000 shares of our common stock, related to our development
of Altoderm, all of which was incurred in the first nine months of 2007.
25
Hedrin
In
June
2007, we entered into an exclusive license agreement with T&R and Kerris,
S.A. (“Kerris”) for a product candidate called Hedrin. We acquired an exclusive
North American license to certain patent rights and other intellectual property
relating to Hedrin, 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.
Hedrin
is
currently marketed as a device in Western Europe and as a pharmaceutical in
the
U.K. In Western Europe Hedrin has achieved sales of $45 million (21% market
share) within 12 months of product launch, and is the market leader in the
U.K.
with $1 million in sales (23% market share). Manhattan Pharmaceuticals is
pursuing a Premarket Approval (PMA) application development pathway for Hedrin
as a medical device, and will request a meeting with the FDA's Center for
Devices and Radiological Health in the fourth quarter of 2007. The Company
expects to be required to complete at least one clinical trial with this product
candidate. Pending the outcome of these regulatory discussions, the Company
expects to initiate clinical activities in 2008.
To
date,
we have incurred $824,000 of project costs, including license fees of $720,000
of which $600,000 was paid in cash and $120,000 of which was satisfied through
the issuance of 150,000 shares of our common stock, related to our development
of Hedrin, all of which was incurred in the first nine 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.
The
Company is working with Thornton and Ross Limited and the current U.K.
manufacturer of Altolyn to develop a GMP compliant manufacturing process.
Pending finalization of this process the company will request a pre-IND meeting
with the FDA and will prepare a pre-IND package. The company believes that
Altolyn may be a candidate for an accelerated 505(b)2 regulatory pathway or
orphan drug designation in the indication of mastocytosis. Oral cromolyn sodium
is the active ingredient in Gastrocrom®
an oral
liquid solution that is currently FDA approved for the treatment of
mastocytosis.
Early
U.K. clinical experience also suggests that Altolyn may have potential for
patients with food allergy and gastrointestinal functional disorders, and the
company intends to pursue these as additional indications.
To
date,
we have incurred $625,000 of project costs, including a license fee of $475,000,
related to our development of Altolyn, all of which was incurred in the first
nine months of 2007.
26
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 have discontinued
our
Oleoyl-estrone programs in both common obesity and morbid obesity.
To
date,
we have incurred $15,319,000 of project costs related to our development of
Oleoyl-estrone, including milestone payments triggered under our license
agreement for Oleoyl-estrone, of which $3,034,000 was incurred in the first
nine
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 $2,984,000 of project costs related to our development of
propofol lingual spray, of which $30,000 was incurred in the first nine 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.
27
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 September 30, 2007, and we have never held such
instruments in the past.
Item
4T. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
As
of
September 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 September 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.
28
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
Swiss
Pharma Contract LTD (“Swiss Pharma”), a clinical site that the Company used in
one of its obesity trials, gave notice to the Company that Swiss Pharma believes
it is entitled to receive an additional payment of $322,776 for services in
connection with that clinical trial. While the contract between the Company
and
Swiss Pharma provides for additional payments if certain conditions are met,
Swiss Parma has not specified which conditions they believe have been achieved
and the Company does not believe that Swiss Pharma is entitled to additional
payments and has not accrued any of these costs as of September 30, 2007. The
contract between the Company and Swiss Pharma provides for arbitration in the
event of a dispute, such as this claim for an additional payment. Swiss Pharma
has filed a demand for arbitration. As the Company does not believe that Swiss
Pharma is entitled to additional payments, it intends to defend its position
in
arbitration.
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
|
|
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
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: November 13, 2007 | By: | /s/ Douglas Abel |
Douglas
Abel
President
and Chief Executive Officer
|
Date: November 13, 2007 | By: | /s/ Michael G. McGuinness |
Michael
G. McGuinness
Chief
Financial Officer
|
30
Index
to Exhibits Filed with this Report
Exhibit
No.
|
Description
|
|
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.
|
31