TG THERAPEUTICS, INC. - Quarter Report: 2008 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
x |
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For
the
quarterly period ended March 31, 2008
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, a non-accelerated filer, or a smaller reporting company. 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
o Smaller
reporting company 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 May
6, 2008 there were 70,624,232 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
|
8
|
|
Notes
to Unaudited Condensed Consolidated Financial Statements
|
9
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
21
|
Item
3.
|
Quantitative
and Qualitative Disclosure About Market Risk
|
35
|
Item
4.
|
Controls
and Procedures
|
35
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1.
|
Legal
Proceedings
|
36
|
Item
1A.
|
Risk
Factors
|
36
|
Item
6.
|
Exhibits
|
36
|
Signatures
|
37
|
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
|
March
31,
2008
|
December
31,
2007
|
|||||
Assets
|
(Unaudited)
|
|
(See
Note 1)
|
||||
Current
assets:
|
|
|
|||||
Cash
and cash equivalents
|
$
|
1,133,124
|
$
|
649,686
|
|||
Prepaid
expenses
|
233,545
|
215,852
|
|||||
|
|||||||
Total
current assets
|
1,366,669
|
865,538
|
|||||
|
|||||||
Property
and equipment, net
|
36,621
|
44,533
|
|||||
Other
assets
|
84,126
|
70,506
|
|||||
|
|||||||
Total
assets
|
$
|
1,487,416
|
$
|
980,577
|
|||
|
|||||||
Liabilities
and Stockholders’ Deficiency
|
|||||||
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
986,223
|
$
|
1,279,485
|
|||
Accrued
expenses
|
800,215
|
592,177
|
|||||
|
|||||||
Total
liabilities
|
1,786,438
|
1,871,662
|
|||||
|
|||||||
Commitments
and contingencies
|
|||||||
|
|||||||
Stockholders’
deficiency:
|
|||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares
issued
|
|||||||
and
outstanding at March 31, 2008 and December 31, 2007
|
|||||||
Common
stock, $.001 par value. Authorized 150,000,000 shares; 70,624,232
|
|||||||
shares
issued and outstanding at March 31, 2008 and December 31,
2007
|
70,624
|
70,624
|
|||||
Additional
paid-in capital
|
56,188,898
|
54,037,361
|
|||||
Deficit
accumulated during the development stage
|
(56,558,544
|
)
|
(54,999,070
|
)
|
|||
|
|||||||
Total
stockholders’ deficiency
|
(299,022
|
)
|
(891,085
|
)
|
|||
|
|||||||
Total
liabilities and stockholders' deficiency
|
$
|
1,487,416
|
$
|
980,577
|
See
accompanying notes to condensed consolidated financial
statements.
|
4
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Condensed
Consolidated Statements of Operations
(Unaudited)
|
Three
months ended March 31,
|
Cumulative
period
from
August
6, 2001
(inception)
to
March
31,
|
||||||||
|
2008
|
2007
|
2008
|
|||||||
Costs
and expenses:
|
|
|
|
|||||||
Research
and development
|
$
|
800,071
|
$
|
1,679,448
|
$
|
27,289,113
|
||||
General
and administrative
|
814,060
|
914,724
|
14,666,424
|
|||||||
In-process
research and development charge
|
—
|
—
|
11,887,807
|
|||||||
Impairment
of intangible assets
|
—
|
—
|
1,248,230
|
|||||||
Loss
on disposition of intangible assets
|
—
|
—
|
1,213,878
|
|||||||
Total
operating expenses
|
1,614,131
|
2,594,172
|
56,305,452
|
|||||||
|
||||||||||
Operating
loss
|
(1,614,131
|
)
|
(2,594,172
|
)
|
(56,305,452
|
)
|
||||
|
||||||||||
Other
(income) expense:
|
||||||||||
Interest
and other income
|
(54,657
|
)
|
(30,390
|
)
|
(876,554
|
)
|
||||
Interest
expense
|
—
|
475
|
26,034
|
|||||||
Realized
gain on sale of marketable equity securities
|
—
|
—
|
(76,032
|
)
|
||||||
Total
other income
|
(54,657
|
)
|
(29,915
|
)
|
(926,552
|
)
|
||||
|
||||||||||
Net
loss
|
(1,559,474
|
)
|
(2,564,257
|
)
|
(55,378,900
|
)
|
||||
|
||||||||||
Preferred
stock dividends (including imputed amounts)
|
—
|
—
|
(1,179,644
|
)
|
||||||
|
||||||||||
Net
loss applicable to common shares
|
$
|
(1,559,474
|
)
|
$
|
(2,564,257
|
)
|
$
|
(56,558,544
|
)
|
|
|
||||||||||
Net
loss per common share:
|
||||||||||
Basic
and diluted
|
$
|
(0.02
|
)
|
$
|
(0.04
|
)
|
||||
|
||||||||||
Weighted
average shares of common stock outstanding:
|
||||||||||
Basic
and diluted
|
70,624,232
|
60,120,038
|
See
accompanying notes to condensed consolidated financial
statements.
|
5
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Condensed
Consolidated Statement of Stockholders’ Equity (Deficiency)
(Unaudited)
Series
A convertible preferred stock
|
Series
A convertible preferred stock
|
Common
stock
|
Common
stock
|
Additional
paid-in capital
|
Subscription
receivable
|
Deficit
accumulated during development stage
|
Dividends
payable in Series A preferred stock
|
Accumulated
other comprehensive income (loss)
|
Unearned
consulting services
|
Total
stockholders’ equity (deficiency)
|
||||||||||||||||||||||||
|
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
|||||||||||||||||||||||
Stock
issued at $0.0004 per share for subscription receivable
|
—
|
$
|
—
|
10,167,741
|
$
|
10,168
|
$
|
(6,168
|
)
|
$
|
(4,000
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(56,796
|
)
|
—
|
—
|
—
|
(56,796
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2001
|
—
|
—
|
10,167,741
|
10,168
|
(6,168
|
)
|
(4,000
|
)
|
(56,796
|
)
|
—
|
—
|
—
|
(56,796
|
)
|
|||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Proceeds
from subscription receivable
|
—
|
—
|
—
|
—
|
—
|
4,000
|
—
|
—
|
—
|
—
|
4,000
|
|||||||||||||||||||||||
Stock
issued at $0.0004 per share for license rights
|
—
|
—
|
2,541,935
|
2,542
|
(1,542
|
)
|
—
|
—
|
—
|
—
|
—
|
1,000
|
||||||||||||||||||||||
Stock
options issued for consulting services
|
—
|
—
|
—
|
—
|
60,589
|
—
|
—
|
—
|
—
|
(60,589
|
)
|
—
|
||||||||||||||||||||||
Amortization
of unearned consulting services
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
22,721
|
22,721
|
|||||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
—
|
—
|
3,043,332
|
3,043
|
1,701,275
|
—
|
—
|
—
|
—
|
—
|
1,704,318
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
(1,037,320
|
)
|
—
|
—
|
—
|
(1,037,320
|
)
|
||||||||||||||||||||||
Balance
at December 31, 2002
|
—
|
—
|
15,753,008
|
15,753
|
1,754,154
|
—
|
(1,094,116
|
)
|
—
|
—
|
(37,868
|
)
|
637,923
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Common
stock issued at $0.63 per share, net of expenses
|
—
|
—
|
1,321,806
|
1,322
|
742,369
|
—
|
—
|
—
|
—
|
—
|
743,691
|
|||||||||||||||||||||||
Effect
of reverse acquisition
|
—
|
—
|
6,287,582
|
6,287
|
2,329,954
|
—
|
—
|
—
|
—
|
—
|
2,336,241
|
|||||||||||||||||||||||
Amortization
of unearned consulting costs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
37,868
|
37,868
|
|||||||||||||||||||||||
Unrealized
loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(7,760
|
)
|
—
|
(7,760
|
)
|
|||||||||||||||||||||
Payment
for fractional shares for stock combination
|
—
|
—
|
—
|
—
|
(300
|
)
|
—
|
—
|
—
|
—
|
—
|
(300
|
)
|
|||||||||||||||||||||
Preferred
stock issued at $10 per share, net of expenses
|
1,000,000
|
1,000
|
—
|
—
|
9,045,176
|
—
|
—
|
—
|
—
|
—
|
9,046,176
|
|||||||||||||||||||||||
Imputed
preferred stock dividend
|
418,182
|
—
|
(418,182
|
)
|
—
|
—
|
||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,960,907
|
)
|
—
|
—
|
—
|
(5,960,907
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2003
|
1,000,000
|
1,000
|
23,362,396
|
23,362
|
14,289,535
|
—
|
(7,473,205
|
)
|
—
|
(7,760
|
)
|
—
|
6,832,932
|
|||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Exercise
of stock options
|
—
|
—
|
27,600
|
27
|
30,073
|
—
|
—
|
—
|
—
|
—
|
30,100
|
|||||||||||||||||||||||
Common
stock issued at $1.10, net of expenses
|
—
|
—
|
3,368,952
|
3,369
|
3,358,349
|
—
|
—
|
—
|
—
|
—
|
3,361,718
|
|||||||||||||||||||||||
Preferred
stock dividend accrued
|
—
|
—
|
—
|
—
|
—
|
—
|
(585,799
|
)
|
585,799
|
—
|
—
|
—
|
||||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
24,901
|
25
|
—
|
—
|
281,073
|
—
|
—
|
(282,388
|
)
|
—
|
—
|
(1,290
|
)
|
|||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(170,528
|
)
|
(171
|
)
|
1,550,239
|
1,551
|
(1,380
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
Warrants
issued for consulting services
|
—
|
—
|
—
|
—
|
125,558
|
—
|
—
|
—
|
—
|
(120,968
|
)
|
4,590
|
||||||||||||||||||||||
Amortization
of unearned consulting costs
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100,800
|
100,800
|
|||||||||||||||||||||||
Unrealized
gain on short-term investments and reversal of unrealized loss on
short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20,997
|
—
|
20,997
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(5,896,031
|
)
|
—
|
—
|
—
|
(5,896,031
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2004
|
854,373
|
854
|
28,309,187
|
28,309
|
18,083,208
|
—
|
(13,955,035
|
)
|
303,411
|
13,237
|
(20,168
|
)
|
4,453,816
|
|||||||||||||||||||||
|
6
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Consolidated
Statement of Stockholders’ Equity (Deficiency)
(Unaudited)
Series
A convertible preferred stock
|
Series
A convertible preferred stock
|
Common
stock
|
Common
stock
|
Additional
paid-in capital
|
Subscription
receivable
|
Deficit
accumulated during development stage
|
Dividends
payable in Series A preferred stock
|
Accumulated
other comprehensive income (loss)
|
Unearned
consulting services
|
Total
stockholders’ equity (deficiency)
|
||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
Amount
|
||||||||||||||||||||||||
Common
stock issued at $1.11 and $1.15, net of expenses
|
—
|
—
|
11,917,680
|
11,918
|
12,238,291
|
—
|
—
|
—
|
—
|
—
|
12,250,209
|
|||||||||||||||||||||||
Common
stock issued to vendor at $1.11 per share in satisfaction of accounts
payable
|
—
|
—
|
675,675
|
676
|
749,324
|
—
|
—
|
—
|
—
|
—
|
750,000
|
|||||||||||||||||||||||
Exercise
of stock options
|
—
|
—
|
32,400
|
33
|
32,367
|
—
|
—
|
—
|
—
|
—
|
32,400
|
|||||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
279,845
|
279
|
68,212
|
—
|
—
|
—
|
—
|
—
|
68,491
|
|||||||||||||||||||||||
Preferred
stock dividend accrued
|
—
|
—
|
—
|
—
|
—
|
—
|
(175,663
|
)
|
175,663
|
—
|
—
|
—
|
||||||||||||||||||||||
Preferred
stock dividends paid by issuance of shares
|
41,781
|
42
|
—
|
—
|
477,736
|
—
|
—
|
(479,074
|
)
|
—
|
—
|
(1,296
|
)
|
|||||||||||||||||||||
Conversion
of preferred stock to common stock at $1.10 per share
|
(896,154
|
)
|
(896
|
)
|
8,146,858
|
8,147
|
(7,251
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
66,971
|
—
|
—
|
—
|
—
|
20,168
|
87,139
|
|||||||||||||||||||||||
Reversal
of unrealized gain on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(12,250
|
)
|
—
|
(12,250
|
)
|
|||||||||||||||||||||
Stock
issued in connection with acquisition of Tarpan Therapeutics,
Inc.
|
—
|
—
|
10,731,052
|
10,731
|
11,042,253
|
—
|
—
|
—
|
—
|
—
|
11,052,984
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(19,140,997
|
)
|
—
|
—
|
—
|
(19,140,997
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2005
|
—
|
—
|
60,092,697
|
60,093
|
42,751,111
|
—
|
(33,271,695
|
)
|
—
|
987
|
—
|
9,540,496
|
||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
27,341
|
27
|
(27
|
)
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
1,675,499
|
—
|
—
|
—
|
—
|
—
|
1,675,499
|
|||||||||||||||||||||||
Unrealized
loss on short-term investments
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
(987
|
)
|
—
|
(987
|
)
|
|||||||||||||||||||||
Costs
associated with private placement
|
—
|
—
|
—
|
—
|
(15,257
|
)
|
—
|
—
|
—
|
—
|
—
|
(15,257
|
)
|
|||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(9,695,123
|
)
|
—
|
—
|
—
|
(9,695,123
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2006
|
—
|
—
|
60,120,038
|
60,120
|
$
|
44,411,326
|
—
|
(42,966,818
|
)
|
—
|
—
|
—
|
1,504,628
|
|||||||||||||||||||||
Common
stock issued at $0.84 and $0.90 per shares, net of
expenses
|
—
|
—
|
10,185,502
|
10,186
|
7,841,999
|
—
|
—
|
—
|
—
|
—
|
7,852,185
|
|||||||||||||||||||||||
Common
stock issued to directors at $0.72 per share in satisfaction of accounts
payable
|
—
|
—
|
27,776
|
28
|
19,972
|
—
|
—
|
—
|
—
|
—
|
20,000
|
|||||||||||||||||||||||
Common
stock issued to in connection with in-licensing agreement at $0.90
per
share
|
—
|
—
|
125,000
|
125
|
112,375
|
—
|
—
|
—
|
—
|
—
|
112,500
|
|||||||||||||||||||||||
Common
stock issued to in connection with in-licensing agreement at $0.80
per
share
|
—
|
—
|
150,000
|
150
|
119,850
|
—
|
—
|
—
|
—
|
—
|
120,000
|
|||||||||||||||||||||||
Exercise
of warrants
|
—
|
—
|
10,327
|
15
|
7,219
|
—
|
—
|
—
|
—
|
—
|
7,234
|
|||||||||||||||||||||||
Cashless
exercise of warrants
|
—
|
—
|
5,589
|
—
|
(6
|
)
|
—
|
—
|
—
|
—
|
—
|
(6
|
)
|
|||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
1,440,956
|
—
|
—
|
—
|
—
|
—
|
1,440,956
|
|||||||||||||||||||||||
Warrants
issued for consulting
|
83,670
|
83,670
|
||||||||||||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(12,032,252
|
)
|
—
|
—
|
—
|
(12,032,252
|
)
|
|||||||||||||||||||||
Balance
at December 31, 2007
|
—
|
—
|
70,624,232
|
70,624
|
54,037,361
|
—
|
(54,999,070
|
)
|
—
|
—
|
—
|
(891,085
|
)
|
|||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
192,854
|
—
|
—
|
—
|
—
|
—
|
192,854
|
|||||||||||||||||||||||
Put
and warrant issued in connection with joint venture
|
—
|
—
|
—
|
—
|
1,958,683
|
—
|
—
|
—
|
—
|
—
|
1,958,683
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
—
|
—
|
(1,559,474
|
)
|
—
|
—
|
—
|
(1,559,474
|
)
|
|||||||||||||||||||||
Balance
at March 31, 2008
|
—
|
$
|
—
|
70,624,232
|
$
|
70,624
|
$
|
56,188,898
|
$
|
—
|
$
|
(56,558,544
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(299,022
|
)
|
See
accompanying notes to condensed consolidated financial
statements.
|
7
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
Three
months ended March 31,
|
Cumulative
period
from
August 6, 2001
(inception)
to
March
31, 2008
|
|||||||||
2008
|
2007
|
2008
|
||||||||
Cash
flows from operating activities:
|
|
|
|
|||||||
Net
loss
|
$
|
(1,559,474
|
)
|
$
|
(2,564,257
|
)
|
$
|
(55,378,900
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Share-based
compensation
|
192,854
|
335,210
|
3,557,837
|
|||||||
Shares
issued in connection with in-licensing agreement
|
—
|
—
|
232,500
|
|||||||
Warrants
issued to consultant
|
—
|
—
|
83,670
|
|||||||
Amortization
of intangible assets
|
—
|
—
|
145,162
|
|||||||
Gain
on sale of marketable equity securities
|
—
|
—
|
(76,032
|
)
|
||||||
Depreciation
|
7,912
|
15,878
|
203,737
|
|||||||
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
|
(17,693
|
)
|
12,494
|
(175,300
|
)
|
|||||
Increase
in other assets
|
—
|
(250,000
|
)
|
(70,506
|
)
|
|||||
Increase
/(decrease) in accounts payable
|
(293,262
|
)
|
150,367
|
1,406,436
|
||||||
Increase
in accrued expenses
|
208,038
|
119,218
|
259,894
|
|||||||
Net
cash used in operating activities
|
(1,461,625
|
)
|
(2,181,090
|
)
|
(35,622,181
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchase
of property and equipment
|
—
|
(6,267
|
)
|
(230,635
|
)
|
|||||
Cash
paid in connection with acquisitions
|
—
|
—
|
(26,031
|
)
|
||||||
Net
cash provided from the purchase and sale of short-term investments,
net
|
—
|
—
|
435,938
|
|||||||
Proceeds
from the sale of license
|
—
|
—
|
200,001
|
|||||||
Investment
in Hedrin JV’s general partner
|
(13,620
|
)
|
—
|
(13,620
|
)
|
|||||
Net
cash (used in) provided by investing activities
|
(13,620
|
)
|
(6,267
|
)
|
365,653
|
|||||
Cash
flows from financing activities:
|
||||||||||
Repayments
of notes payable to stockholders
|
—
|
—
|
(884,902
|
)
|
||||||
Proceeds
related to sale of common stock, net
|
—
|
7,848,031
|
25,896,262
|
|||||||
Proceeds
from sale of preferred stock, net
|
—
|
—
|
9,046,176
|
|||||||
Proceeds
from exercise of warrants and stock options
|
—
|
—
|
138,219
|
|||||||
Proceeds
from the put and warrant issued in the Hedrin JV
|
1,958,683
|
—
|
1,958,683
|
|||||||
Other,
net
|
—
|
—
|
235,214
|
|||||||
Net
cash provided by financing activities
|
1,958,683
|
7,848,031
|
36,389,652
|
|||||||
Net
increase in cash and cash equivalents
|
483,438
|
5,660,674
|
1,133,124
|
|||||||
Cash
and cash equivalents at beginning of period
|
649,686
|
3,029,118
|
—
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
1,133,124
|
$
|
8,689,792
|
$
|
1,133,124
|
||||
|
||||||||||
Supplemental
disclosure of cash flow information:
|
||||||||||
Interest
paid
|
—
|
$
|
$475
|
$
|
26,033
|
|||||
|
||||||||||
Supplemental
disclosure of noncash investing and financing activities:
|
||||||||||
Common
stock issued in satisfaction of accounts payable
|
$
|
—
|
$
|
—
|
$
|
770,000
|
||||
Imputed
preferred stock dividend
|
—
|
—
|
418,182
|
|||||||
Preferred
stock dividends accrued
|
—
|
—
|
761,462
|
|||||||
Preferred
stock dividends paid by issuance of shares
|
—
|
—
|
759,134
|
|||||||
Conversion
of preferred stock to common stock
|
—
|
—
|
1,067
|
|||||||
Issuance
of common stock for acquisitions
|
—
|
—
|
13,389,226
|
|||||||
Issuance
of common stock in connection with in-licensing agreement
|
—
|
—
|
232,500
|
|||||||
Marketable
equity securities received in connection with sale of
license
|
—
|
—
|
359,907
|
|||||||
Warrants
issued to consultant
|
—
|
—
|
83,670
|
|||||||
Net
liabilities assumed over assets acquired in business
combination
|
—
|
—
|
(675,416
|
)
|
||||||
Cashless
exercise of warrants
|
—
|
27
|
33
|
See
accompanying notes to condensed consolidated financial
statements.
|
8
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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, 2008 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, 2007, which are included in the
Company’s Annual Report on Form 10-K for such year. The condensed balance sheet
as of December 31, 2007 has been derived from the audited financial statements
included in the Form 10-K for that year.
As
of
December 31, 2006 all of the Company’s subsidiaries had either been dissolved or
merged into Manhattan. As a result, the Company had no subsidiaries during
the
three month period ended March 31, 2008 and 2007.
As
of
March 31, 2008, the Company has not generated any revenues from the development
of its products and is therefore considered to be a development stage
company.
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 consolidated 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.
Equity
in Joint Venture
The
Company accounts for its investment in joint venture (See Note 7) using the
equity method of accounting. Under the equity method, the Company records its
pro-rata share of joint venture income or losses and adjusts the basis of its
investment accordingly. At March 31, 2008, the Company has no equity in joint
venture.
9
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
New
Accounting Pronouncements
In
March
2008, the FASB issued SFAS No. 161 "Disclosures About Derivative Instruments
and
Hedging Activities - an amendment of FASB Statement No. 133" ("SFAS 161").
SFAS
161 amends SFAS 133 by requiring expanded disclosures about an entity's
derivative instruments and hedging activities. SFAS 161 requires qualitative
disclosures about objectives and strategies for using derivatives, quantitative
disclosures about fair value amounts of and gains and losses on derivative
instruments, and disclosures about credit-risk-related contingent features
in
derivative instruments. SFAS 161 is effective for the Company as of January
1,
2009. The Company does not believe that SFAS 161 will have any impact on its
consolidated financial statements.
2. |
LIQUIDITY
|
The
Company incurred a net loss of $1,559,474 and negative cash flows from operating
activities of $1,461,625 for the three month period ended March 31, 2008. The
net loss applicable to common shares from date of inception, August 6, 2001,
to
March 31, 2008 amounts to $56,558,544.
The
Company received approximately $7.9 million net from a private placement of
common stock and warrants in March 2007. This private placement is more fully
described in Note 6.
The
Company received approximately $2.0 million from a joint venture agreement
in
February 2008. This joint venture agreement is more fully described in Note
7.
Management
believes that the Company will continue to incur net losses through at least
March 31, 2009 and for the foreseeable future thereafter. Based on the resources
of the Company available at December 31, 2007 and the net proceeds received
from
the February 2008 joint venture agreement, management does not believe that
the
Company has sufficient capital to fund its operations through 2008. 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 through 2008.
Furthermore, we will need additional financing thereafter to complete
development and commercialization of our products. There can be no assurances
that we can successfully complete development and commercialization of our
products.
These
matters raise substantial doubt about the Company’s ability to continue as a
going concern. The accompanying condensed consolidated financial statements
do
not include any adjustments that might result from the outcome of this
uncertainty.
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.
10
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 19,685,161 and 17,886,567 as of March 31, 2008 and 2007,
respectively. These amounts do not include the shares issuable in connection
with the Hedrin JV (see Note 7); the 17,857,143 shares of common stock issuable
upon exercise of the put or call rights; the up to 17,857,143 additional shares
which may become issuable upon exercise of a conditionally issuable put or
call
rights and the 7,142,857 shares of common stock issuable upon exercise of a
conditionally issuable warrant.
4. |
SHARE-BASED
COMPENSATION
|
Effective
January 1, 2006, the Company adopted Statement of Financial Accounting Standards
No. 123(R), “Share-Based Payment,” (“Statement 123(R)”) for employee options
using the modified prospective transition method. Statement 123(R) revised
Statement 123 “Accounting for Stock-based Compensation” to eliminate the option
to use the intrinsic value method and required the Company to expense the fair
value of all employee options over the vesting period. Under the modified
prospective transition method, the Company recognized compensation cost for
the
three month periods ending March 31, 2008 and 2007 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 recognizes compensation expense related to stock option grants on a
straight-line basis over the vesting period. The Company recognized share-based
compensation cost of $192,308 and $335,210 for the three month periods ended
March 31, 2008 and 2007, 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 March 31, 2008 and 2007, net of
amortization, the Company recognized share-based compensation cost of $546
and
$3,371, respectively, for the three month periods ended March 31, 2008 and
2007,
respectively.
11
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Company has allocated share-based compensation costs and credits to general
and
administrative and research and development expenses as follows:
Three
months ended March 31,
|
|
||||||
|
|
2008
|
|
2007
|
|||
General
and administrative expense:
|
|||||||
Share-based
employee compensation costs
|
$
|
140,043
|
$
|
221,921
|
|||
Share-based
consultant and non-employee costs
|
— | 10,550 | |||||
Total
general and administrative expense
|
$
|
140,043
|
$
|
232,471
|
|||
Research
and development expense:
|
|||||||
Share-based
employee compensation costs
|
$
|
52,265
|
$
|
109,918
|
|||
Share-based
consultant and non-employee (credits) costs
|
546 | (7,179 | ) | ||||
Total
research and development expense
|
$
|
52,811
|
$
|
102,739
|
|||
Total
share-based costs
|
$
|
192,854
|
$
|
335,210
|
To
compute compensation expense in 2008 and 2007, 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.
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 2008 and 2007:
Three
months ended March 31,
|
||||
|
2008
|
|
2007
|
|
Expected
Volatility
|
93%
|
55%
|
||
Dividend
yield
|
—
|
—
|
||
Expected
term (in years)
|
6
|
6
|
||
Risk-free
interest rate
|
2.81%
|
4.88%
|
12
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 March
31, 2008, under the 2003 Plan, 10,400,000 shares of common stock were authorized
for issuance. At March 31, 2008, under the 2003 Plan, options to purchase
9,864,068 shares of common stock were outstanding. 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 2,967,500 shares of common stock during the three
months ended March 31, 2008 at an exercise price of $0.17 per share. In
addition, 27,776 shares of common stock were issued during 2007 under the 2003
Plan.
At
March
31, 2008, there were 508,156 shares reserved for future grants under the 2003
Plan. In
July
1995, the Company established the 1995 Stock Option Plan (the”1995 Plan”), which
provided for the granting of options to purchase up to 130,000 shares of the
Company’s common stock to officers, directors, employees and consultants. The
1995 Plan was amended several times to increase the number shares reserved
for
stock option grants. In June 2005, the 1995 Plan expired and no further options
can be granted. As of March 31, 2008, options to purchase 1,137,240 shares
were
outstanding under the 1995 Plan and no shares were reserved for future stock
option grants.
A
summary
of the status of the Company’s outstanding stock options as of March 31, 2008
and changes during the three months then ended is presented below:
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
at December 31, 2007
|
8,033,808
|
$
|
1.25
|
||||||||||
Granted:
|
|||||||||||||
Officers
|
2,400,000
|
||||||||||||
Directors
|
375,000
|
||||||||||||
Employees
|
192,500
|
||||||||||||
Total
granted
|
2,967,500
|
0.17
|
|||||||||||
Exercised
|
-
|
||||||||||||
Cancelled
|
-
|
||||||||||||
Outstanding
at March 31, 2008
|
11,001,308
|
$
|
0.96
|
7.55
|
$
|
500
|
|||||||
Exercisable
at March 31, 2008
|
6,687,574
|
$
|
1.10
|
6.96
|
|||||||||
Weighted
average fair value of options granted during the three months ended
March
31, 2008
|
$
|
0.13
|
13
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
As
of
March 31, 2008, the total compensation cost related to non-vested option awards
not yet recognized is $717,769. The weighted average period over which it is
expected to be recognized is approximately 1.5 years.
5. |
COMMITMENTS
AND CONTINGENCIES
|
Swiss
Pharma
Swiss
Pharma Contract LTD, or 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 March 31, 2008 and
December 31, 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. On March 10, 2008, Swiss Pharma filed for arbitration with the Swiss
Chamber of Commerce. As the Company does not believe that Swiss Pharma is
entitled to additional payments, the Company intends to defend its position
in
arbitration. On April 2, 2008, the Company filed its statement of defense and
counterclaim for recovery of costs incurred by the Company as a result of Swiss
Pharma’s failure to meet agreed upon deadlines under the contract.
Therapeutics,
Inc.
During
2007, we entered into an agreement with Therapeutics, Inc. for the conduct
of a
Phase 2a clinical trial of PTH (1-34). The amount of the agreement is
approximately $845,000. The remaining financial commitment at March 31, 2008
related to the conduct of the clinical trial is approximately $430,000. This
clinical trial is expected to conclude in the second quarter of
2008.
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.
14
Employment
Agreements
The
Company has employment agreements with two employees for the payment of
aggregate annual base salaries of $655,000 as well as performance based bonuses.
These agreements have a remaining term of one year for one of the employees,
and
15 months for the second employee, and have a total remaining obligation under
these agreements of $738,000 as of March 31, 2008.
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 March 31, 2008 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. (“Paramount”), 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.
7. |
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.
15
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 License Agreement”) with T&R and Kerris, S.A. (“Kerris”).
Pursuant to the Hedrin License 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 (the “Hedrin Supply Agreement”).
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 Hedrin 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 License Agreement with the consent of Licensor and the proceeds
resulting from such sublicenses will be shared with the Licensor.
16
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Pursuant
to the Hedrin 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 Hedrin Supply Agreement, the Company may obtain products from an alternative
supplier subject to certain conditions. The term of the Hedrin Supply Agreement
ends upon termination of the Hedrin License Agreement.
Joint
Venture with Nordic
In
February 2008, the Company and Nordic Biotech Advisors ApS through its
investment fund Nordic Biotech Venture Fund II K/S (“Nordic”) entered into a
50/50 joint venture agreement (the “Hedrin JV Agreement”) to develop and
commercialize the Company's North American rights (under license) to its Hedrin
product.
Pursuant
to the Hedrin JV Agreement, Nordic formed a new Danish limited partnership
(the
"Hedrin JV") and provided it with initial funding of $2.5 million. On February
25, 2008 the Company assigned and transferred its North American rights in
Hedrin to the Hedrin JV in return for a $2.0 million cash payment and equity
in
the Hedrin JV representing 50% of the nominal equity interests in the Hedrin
JV.
As of March 31, 2008, the Company has included the $2.0 million cash payment
in
equity in the attached condensed consolidated financial statements representing
the sale of a put and a call to Nordic, as described below.
Should
the Hedrin JV be successful in achieving a payment milestone, namely that by
September 30, 2008, the FDA determines to treat Hedrin as a medical device,
Nordic will purchase an additional $2.5 million of equity in the Hedrin JV,
whereupon the Hedrin JV will pay the Company an additional $1.5 million in
cash
and issue to the Company an additional $2.5 million in equity in the Hedrin
JV,
thereby maintaining the Company’s 50% ownership interest in the Hedrin
JV.
The
Hedrin JV is responsible for the development and commercialization of Hedrin
for
the North American market and all associated costs including clinical trials,
if
required, regulatory costs, patent costs, and future milestone payments owed
to
T&R, the licensor of Hedrin.
The
Hedrin JV has engaged the Company to provide management services to the Limited
Partnership in exchange for a management fee, which for 2008, on an annualized
basis, is $527,000. As of March 31, 2008, the Company has recognized $51,496
of
other income from management fees earned from the Hedrin JV.
Nordic
paid to the Company a non-refundable fee of $150,000 at the closing for the
right to receive a warrant covering 7.1 million shares of the Company’s common
stock, exercisable for $0.14 per share. The warrant is issuable 90 days from
closing, provided Nordic has not exercised all or a part of its put, as
described below. The Company issued the warrant to Nordic on April 30, 2008.
The
per share exercise price of the warrant was based on the volume weighted average
price of the Company’s common stock for the period prior to the signing of the
Hedrin JV Agreement.
Nordic
has an option to put all or a portion of its equity interest in the Hedrin
JV to
the Company in exchange for the Company’s common stock. The shares of the
Company’s common stock to be issued upon exercise of the put will be calculated
by multiplying the percentage of Nordic’s equity in the Hedrin JV that Nordic
decides to put to the Company multiplied by the dollar amount of Nordic’s
investment in Limited Partnership divided by $0.14, as adjusted from time to
time. The put option is exercisable immediately and expires at the earlier
of
ten years or when Nordic’s distributions from the Limited Hedrin JV exceed five
times the amount Nordic invested in the Hedrin JV.
17
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Company has an option to call all or a portion of Nordic’s equity interest in
the Hedrin JV in exchange for the Company’s common stock. The Company cannot
begin to exercise its call until the price of the Company’s common stock has
closed at or above $1.40 per share for 30 consecutive trading days. During
the
first 30 consecutive trading day period in which the Company’s common stock
closes at or above $1.40 per share the Company can exercise up to 25% of its
call option. During the second 30 consecutive trading day period in which the
Company’s common stock closes at or above $1.40 per share the Company can
exercise up to 50% of its call option on a cumulative basis. During the third
30
consecutive trading day period in which the Company’s common stock closes at or
above $1.40 per share the Company can exercise up to 75% of its call option
on a
cumulative basis. During the fourth 30 consecutive trading day period in which
the Company’s common stock closes at or above $1.40 per share the Company can
exercise up to 100% of its call option on a cumulative basis. The shares of
the
Company’s common stock to be issued upon exercise of the call will be calculated
by multiplying the percentage of Nordic’s equity in the Limited Partnership that
the Company calls, as described above, multiplied by the dollar amount of
Nordic’s investment in the Hedrin JV divided by $0.14. Nordic can refuse the
Company’s call by either paying the Company up to $1.5 million or forfeiting all
or a portion of their put, calculated on a pro rata basis for the percentage
of
the Nordic equity interest called by the Company.
The
Hedrin JV's Board consists of 4 members, 2 appointed by the Company and 2
appointed by Nordic. Nordic has the right to appoint one of the directors as
chairman of the Board. The chairman has certain tie breaking powers. In the
event that the payment milestone described above is not achieved by June 30,
2008, then the Hedrin JV's Board will increase to 5 members, 2 appointed by
the
Company and 3 appointed by Nordic.
After
the
closing, at Nordic's request, the Company will nominate a person identified
by
Nordic to serve on the Company’s Board of Directors.
The
Company granted Nordic registration rights for the shares to be issued upon
exercise of the warrant, the put or the call. The Company filed an initial
registration statement on May 1, 2008. The Company is required to file
additional registration statements, if required, within 45 days of the date
the
Company first knows that such additional registration statement was required.
The Company is required to use commercially reasonable efforts to cause the
registration statement to be declared effective by the Securities and Exchange
Commission (“SEC”) within 105 calendar days from the filing date. If the Company
fails to file a registration statement on time or if a registration statement
is
not declared effective by the SEC within 105 days of filing the Company will
be
required to pay to Nordic, or its assigns, an amount in cash, as partial
liquidated damages, equal to 0.5% per month of the amount invested in the Hedrin
JV by Nordic until the registration statement is declared effective by the
SEC.
In no event shall the aggregate amount payable by the Company exceed 9% of
the
amount invested in the Hedrin JV by Nordic.
The
profits of the Hedrin JV will be shared by the Company and Nordic in accordance
with their respective equity interests in Limited Partnership, which are
currently 50% to each, except that Nordic will get a minimum distribution from
the Hedrin JV equal to 5% on Hedrin sales, as adjusted for any change in
Nordic’s equity interest in the Limited Partnership. If the Hedrin JV realizes a
profit equal to or greater than a 10% royalty on Hedrin sales, then profits
will
be shared by the Company and Nordic in accordance with their respective equity
interests in the Limited Partnership. However, in the event of a liquidation
of
the Limited Partnership, Nordic’s distribution in liquidation will be at least
equal to the amount Nordic invested in the Hedrin JV ($5 million if the payment
milestone described above is met, $2.5 million if it is not met) plus 10% per
year, less the cumulative distributions received by Nordic from the Hedrin
JV.
Further, in no event shall Nordic’s distribution in liquidation be greater than
assets available for distribution in liquidation.
18
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Due
to
the complexity of the accounting for the $2.0 million of cash received in the
Hedrin JV transaction, the Company has requested guidance from the SEC in
concluding on the appropriate accounting for this transaction. The accounting
as
currently disclosed in the condensed consolidated financial statements is still
under review and may be subject to change.
American
Stock Exchange
In
September 2007, the Company received notice from the staff of The American
Stock
Exchange, or AMEX, indicating that the Company was not in compliance with
certain continued listing standards set forth in the AMEX Company Guide.
Specifically, AMEX notice cited the Company’s failure to comply, as of June 30,
2007, with section 1003(a)(ii) of the AMEX Company Guide as the Company had
less
than $4,000,000 of stockholders’ equity and had losses from continuing
operations and /or net losses in three or four of our most recent fiscal years
and with section 1003(a)(iii) which requires the Company to maintain $6,000,000
of stockholders’ equity if the Company has experienced losses from continuing
operations and /or net losses in its five most recent fiscal years.
In
order
to maintain our AMEX listing, the Company was required to submit a plan to
AMEX
advising the exchange of the actions the Company has taken, or will take, that
would bring the Company into compliance with all the continued listing standards
by April 16, 2008. The Company submitted such a plan in October 2007. If the
Company is not in compliance with the continued listing standards at the end
of
the plan period, or if the Company has not made progress consistent with the
plan during the period, AMEX staff could have initiated delisting
proceedings.
Under
the
terms of the Hedrin JV Agreement, the number of potentially issuable shares
represented by the put and call features thereof and the warrant issuable to
Nordic, would exceed 19.9% of the Company’s total outstanding shares and would
be issued at a price below the greater of book or market value. As a result,
under AMEX regulations, the Company would not have been able to complete the
transaction without first receiving either stockholder approval for the
transaction, or a formal “financial viability” exception from AMEX’s stockholder
approval requirement. The Company estimated that obtaining stockholder approval
to comply with AMEX regulations would take a minimum of 45 days to complete.
The
Company discussed the financial viability exception with AMEX for several weeks
and had neither received the exception nor been denied the exception. The
Company determined that our financial condition required the Company to complete
the transaction immediately, and that the Company’s financial viability depended
on the completion of the Hedrin JV Agreement without further delay.
19
MANHATTAN
PHARMACEUTICALS, INC. and SUBSIDIARIES
(A
Development Stage Company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Accordingly,
to maintain the Company’s financial viability, on February 28, 2008, the Company
announced that it had formally notified AMEX that the Company intended to
voluntarily delist its common stock from AMEX. The delisting became effective
on
March 26, 2008.
The
Company’s common stock now trades on the Over the Counter Bulletin Board under
the symbol “MHAN”. The Company intends to maintain corporate governance,
disclosure and reporting procedures consistent with applicable law.
20
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-K for the year ended
December 31, 2007 (the “Annual Report”) and our financial statements as of
and for the three month period ended March 31, 2008 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 on Form
10-K, and should not unduly rely on these forward-looking
statements.
21
RESULTS
OF OPERATIONS
THREE-MONTH
PERIOD ENDED MARCH 31, 2008 VS 2007
Quarter
ended March 31,
|
|||||||||||||
2008
|
2007
|
Increase
(decrease)
|
%
Increase (decrease)
|
||||||||||
COSTS
AND EXPENSES
|
|||||||||||||
Research
and development
|
|||||||||||||
Share-based
compensation
|
$
|
53,000
|
$
|
103,000
|
($50,000
|
)
|
(48.5
|
)%
|
|||||
Other
research and development expense
|
$
|
747,000
|
$
|
1,576,000
|
($829,000
|
)
|
(52.6
|
)%
|
|||||
Total
research and development expense
|
$
|
800,000
|
$
|
1,679,000
|
($879,000
|
)
|
(52.4
|
)%
|
|||||
General
and administrative
|
|||||||||||||
Share-based
compensation
|
$
|
140,000
|
$
|
232,000
|
($92,000
|
)
|
(39.7
|
)%
|
|||||
Other
general and administrative expense
|
$
|
674,000
|
$
|
683,000
|
($9,000
|
)
|
(1.3
|
)%
|
|||||
Total
general and administrative expense
|
$
|
814,000
|
$
|
915,000
|
($101,000
|
)
|
(11.0
|
)%
|
|||||
Other
income
|
$
|
54,000
|
$
|
30,000
|
$
|
24,000
|
80.00
|
%
|
|||||
NET
LOSS
|
($1,560,000
|
)
|
($2,564,000
|
)
|
$
|
1,004,000
|
(39.2
|
)%
|
During
each of the quarters ended March 31, 2008 and 2007 we did not recognize any
revenues. We are considered a development stage company, and do not expect
to
have revenues relating to our technologies prior to March 31, 2009, if at all.
For
the
quarter ended March 31, 2008 total research and development expense was $800,000
as compared to $1,679,000 for the quarter ended March 31, 2007. The decrease
of
$879,000, or 52.4%, is attributable to a decrease of $1,427,000 in development
costs for OE offset by increases in development costs for PTH (1-34) of
$436,000, Altoderm of $79,000 and Altolyn of $33,000. There were no development
costs in the 2008 quarter for OE as the development project was terminated
during 2007. The increase in development costs for PTH (1-34) is due to the
costs of the ongoing Phase 2a clinical study. There were no development costs
for Altoderm and Altolyn in the 2007 quarter as these products were acquired
in
the second quarter of 2007.
For
the
quarter ended March 31, 2008 total general and administrative expense was
$814,000 as compared to $915,000 for the quarter ended March 31, 2007. The
decrease of $101,000, or 11.0%, is primarily attributable to a decrease of
$92,000 in stock based compensation.
For
the
three months ended March 31, 2008, other income was $54,000 as compared to
$30,000 for the three months ended March 31, 2007. The increase of $24,000,
or
80%, is due primarily to $51,000 of management fees received in accordance
with
the services agreement from the Nordic JV, offset by 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 March 31, 2008 was $1,560,000 as compared to
$2,564,000 million for the three months ended March 31, 2007. The decrease
of
$1,004,000, or 39.2%, in net loss is principally attributable to a decrease
in
research and development expense of $879,000 and, a decrease in general and
administrative expense of $101,000.
22
LIQUIDITY
AND CAPITAL RESOURCES
From
inception to March 31, 2008, we incurred a deficit during the development stage
of $56.6 million primarily as a result of our net losses and preferred stock
dividends. We expect to continue to incur additional losses through at least
March 31, 2009 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.
During the three months ended March 31, 2008, we had a net increase in cash
and
cash equivalents of $0.5 million. This increase resulted principally from
proceeds from the Hedrin JV Agreement of $2.0, partially offset by net cash
used
in operating activities of $1.5 million. Total liquid resources as of March
31,
2008 were $1.1 million compared to $0.6 million at December 31,
2007.
Liquidity
As
of
March 31, 2008, we had a working capital deficit of $420,000 as compared to
a
working capital deficit of $1,006,000 at December 31, 2007. This $586,000
reduction in the working capital deficit is primarily due to the net proceeds
received in the Hedrin JV transaction of $1,959,000 and a decrease in accounts
payable and accrued expenses of $85,000 offset by the net cash used in operating
activities of $1,462,000.
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 March 31, 2008 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.
JOINT
VENTURE AGREEMENT
In
February 2008, the Company and Nordic Biotech Advisors ApS through its
investment fund Nordic Biotech Venture Fund II K/S (“Nordic”) entered into a
50/50 joint venture agreement (the “Hedrin JV Agreement”) to develop and
commercialize the Company's North American rights (under license) to its Hedrin
product.
23
Pursuant
to the Hedrin JV Agreement, Nordic formed a new Danish limited partnership
(the
"Hedrin JV") and provided it with initial funding of $2.5 million. The Company
assigned and transferred its North American rights in Hedrin to the Hedrin
JV in
return for a $2.0 million cash payment and equity in the Hedrin JV representing
50% of the nominal equity interests in the Hedrin JV .
Should
the Hedrin JV be successful in achieving a payment milestone, namely that by
September 30, 2008, the FDA determines to treat Hedrin as a medical device,
Nordic will purchase an additional $2.5 million of equity in the Hedrin JV,
whereupon the Hedrin JV will pay the Company an additional $1.5 million in
cash
and issue to the Company an additional $2.5 million in equity in the Hedrin
JV,
thereby maintaining the Company’s 50% ownership interest in the Hedrin
JV.
The
Hedrin JV is responsible for the development and commercialization of Hedrin
for
the North American market and all associated costs including clinical trials,
if
required, regulatory costs, patent costs, and future milestone payments owed
to
T&R, the licensor of Hedrin.
The
Hedrin JV has engaged the Company to provide management services to the Limited
Partnership in exchange for an annualized management fee, which for 2008, on
an
annualized basis, is $527,000. For the three months ended March 31, 2008, the
Company has recognized $51,496 of other income from the performance of such
management services in revenues from management fees received from the Hedrin
JV.
Nordic
paid to the Company a non-refundable fee of $150,000 at the closing for the
right to receive a warrant covering 7.1 million shares of the Company’s common
stock, exercisable for $0.14 per share. The warrant is issuable 90 days from
closing, provided Nordic has not exercised all or a part of its put, as
described below. The Company issued the warrant to Nordic on April 30, 2008.
The
per share exercise price of the warrant was based on the volume weighted average
price of the Company’s common stock for the period prior to the signing of the
Hedrin JV Agreement.
Nordic
has an option to put all or a portion of its equity interest in the Hedrin
JV to
the Company in exchange for the Company’s common stock. The shares of the
Company’s common stock to be issued upon exercise of the put will be calculated
by multiplying the percentage of Nordic’s equity in the Hedrin JV that Nordic
decides to put to the Company multiplied by the dollar amount of Nordic’s
investment in Limited Partnership divided by $0.14, as adjusted from time to
time. The put option is exercisable immediately and expires at the earlier
of
ten years or when Nordic’s distributions from the Limited Hedrin JV exceed five
times the amount Nordic invested in the Hedrin JV.
The
Company has an option to call all or a portion of Nordic’s equity interest in
the Hedrin JV in exchange for the Company’s common stock. The Company cannot
begin to exercise its call until the price of the Company’s common stock has
closed at or above $1.40 per share for 30 consecutive trading days. During
the
first 30 consecutive trading day period in which the Company’s common stock
closes at or above $1.40 per share the Company can exercise up to 25% of its
call option. During the second 30 consecutive trading day period in which the
Company’s common stock closes at or above $1.40 per share the Company can
exercise up to 50% of its call option on a cumulative basis. During the third
30
consecutive trading day period in which the Company’s common stock closes at or
above $1.40 per share the Company can exercise up to 75% of its call option
on a
cumulative basis. During the fourth 30 consecutive trading day period in which
the Company’s common stock closes at or above $1.40 per share the Company can
exercise up to 100% of its call option on a cumulative basis. The shares of
the
Company’s common stock to be issued upon exercise of the call will be calculated
by multiplying the percentage of Nordic’s equity in the Limited Partnership that
the Company calls, as described above, multiplied by the dollar amount of
Nordic’s investment in the Hedrin JV divided by $0.14. Nordic can refuse the
Company’s call by either paying the Company up to $1.5 million or forfeiting all
or a portion of their put, calculated on a pro rata basis for the percentage
of
the Nordic equity interest called by the Company.
24
The
Hedrin JV 's Board consists of 4 members, 2 appointed by the Company and 2
appointed by Nordic. Nordic has the right to appoint one of the directors as
chairman of the Board. The chairman has certain tie breaking powers. In the
event that the payment milestone described above is not achieved by June 30,
2008, then the Hedrin JV 's Board will increase to 5 members, 2 appointed by
the
Company and 3 appointed by Nordic.
After
the
closing, at Nordic's request, the Company will nominate a person identified
by
Nordic to serve on the Company’s Board of Directors.
The
Company granted Nordic registration rights for the shares to be issued upon
exercise of the warrant, the put or the call. The Company filed an initial
registration statement on May 1, 2008. The Company is required to file
additional registration statements, if required, within 45 days of the date
the
Company first knows that such additional registration statement was required.
The Company is required to use commercially reasonable efforts to cause the
registration statement to be declared effective by the Securities and Exchange
Commission (“SEC”) within 105 calendar days from the filing date. If the Company
fails to file a registration statement on time or if a registration statement
is
not declared effective by the SEC within 105 days of filing the Company will
be
required to pay to Nordic, or its assigns, an amount in cash, as partial
liquidated damages, equal to 0.5% per month of the amount invested in the Hedrin
JV by Nordic until the registration statement is declared effective by the
SEC.
In no event shall the aggregate amount payable by the Company exceed 9% of
the
amount invested in the Hedrin JV by Nordic.
The
profits of the Hedrin JV will be shared by the Company and Nordic in accordance
with their respective equity interests in Limited Partnership, which are
currently 50% to each, except that Nordic will get a minimum distribution from
the Hedrin JV equal to 5% on Hedrin sales, as adjusted for any change in
Nordic’s equity interest in the Limited Partnership. If the Hedrin JV realizes a
profit equal to or greater than a 10% royalty on Hedrin sales, then profits
will
be shared by the Company and Nordic in accordance with their respective equity
interests in the Limited Partnership. However, in the event of a liquidation
of
the Limited Partnership, Nordic’s distribution in liquidation will be at least
equal to the amount Nordic invested in the Hedrin JV ($5 million if the payment
milestone described above is met, $2.5 million if it is not met) plus 10% per
year, less the cumulative distributions received by Nordic from the Hedrin
JV.
Further, in no event shall Nordic’s distribution in liquidation be greater than
assets available for distribution in liquidation.
American
Stock Exchange
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 AMEX Company Guide. Specifically,
AMEX 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 $4,000,000 of
stockholders’ equity and had losses from continuing operations and /or net
losses in three or four of our 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.
25
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 were not in compliance with the
continued listing standards at the end of the plan period, or if we had made
progress consistent with the plan during the period, AMEX staff could have
initiated delisting proceedings.
Under
the
terms of our joint venture agreement with Nordic, the number of potentially
issuable shares represented by the put and call features thereof and the warrant
issuable to Nordic, would exceed 19.9% of our total outstanding shares and
would
be issued at a price below the greater of book or market value. As a result,
under AMEX regulations, we would not have been able to complete the transaction
without first receiving either stockholder approval for the transaction, or
a
formal “financial viability” exception from AMEX’s stockholder approval
requirement. We estimated that obtaining stockholder approval to comply with
AMEX regulations would take a minimum of 45 days to complete. We discussed
the
financial viability exception with AMEX for several weeks and had neither
received the exception nor been denied the exception. We determined that our
financial condition required us to complete the transaction immediately, and
that our financial viability depended on our completion of the transaction
without further delay.
Accordingly,
to maintain our financial viability, on February 28, 2008, we announced that
we
had formally notified AMEX that we intended to voluntarily delist our common
stock from AMEX. The delisting became effective on March 26, 2008.
Our
common stock now trades on the Over the Counter Bulletin Board under the symbol
“MHAN”. We intend to maintain corporate governance, disclosure and reporting
procedures consistent with applicable law.
Commitments
General
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 nonclinical 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.
During
2007, we entered into an agreement with Therapeutics, Inc. for the conduct
of a
Phase 2a clinical trial of Topical PTH (1-34). The amount of the agreement
is
approximately $845,000. The remaining financial commitment at March 31, 2008
related to the conduct of the clinical trial is approximately $430,000. This
clinical trial is expected to conclude in the second quarter of 2008.
26
Swiss
Pharma Contract LTD, or Swiss Pharma, a clinical site that we used in one of
its
obesity trials, gave notice to us 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 us 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 we do not believe that
Swiss Pharma is entitled to additional payments and has not accrued any of
these
costs as of December 31, 2007. The contract between us and Swiss Pharma provides
for arbitration in the event of a dispute, such as this claim for an additional
payment. On March 10, 2008, Swiss Pharma filed for arbitration with the Swiss
Chamber of Commerce. As we do not believe that Swiss Pharma is entitled to
additional payments, we intend to defend our position in arbitration. On April
2, 2008, we filed our statement of defense and counterclaim for recovery of
costs incurred by us as a result of Swiss Pharma’s failure to meet agreed upon
deadlines under our contract.
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.
Development
Commitments
Hedrin
On
June
26, 2007, we entered into an exclusive license agreement for Hedrin (the “Hedrin
License Agreement”) with Thornton & Ross Ltd, or T&R, and Kerris, S.A.,
or Kerris (jointly, the “Licensor”). Pursuant to the Hedrin License Agreement,
we acquired an exclusive North American license to certain patent rights and
other intellectual property relating to HedrinTM
a
non-insecticide product candidate for the treatment of pediculosis (head lice).
In addition, on June 26, 2007, we entered into a supply agreement with T&R
pursuant to which T&R will be our exclusive supplier of Hedrin product (the
“Hedrin Supply Agreement”).
In
consideration for the license, we issued to Licensor 150,000 shares of our
common stock valued at $120,000. In addition, we also made a cash payment to
the
Licensor of $600,000 . These amounts are included in research and development
expense.
Further,
we agreed to make future milestone payments to the Licensor comprised of various
combinations of cash and common stock in respective aggregate amounts of
$2,500,000 upon the achievement of various clinical and regulatory milestones
as
follows: $250,000 upon acceptance by the U. S. Food and Drug Administration,
or
the FDA, of an Investigational New Drug application, or an IND; $1,000,000
upon
the achievement of a successful outcome of a Phase 3 clinical trial; $700,000
upon the final approval of an NDA by the FDA; $300,000 upon the issuance of
a
U.S. patent on Hedrin: and $250,000 upon receipt of marketing authorization
in
Canada.
We
also
agreed to pay royalties of 8% (or, under certain circumstances, 4%) on net
sales
of licensed products. Our exclusivity under the Hedrin 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. We may sublicense our rights under the
Hedrin License Agreement with the consent of the Licensor and the proceeds
resulting from such sublicenses will be shared with the Licensor.
27
Through
March 31, 2008, none of the milestones have been reached and sales have not
commenced, therefore, we have not paid any such milestones or
royalties.
Pursuant
to the Hedrin Supply Agreement, we have agreed that we and our 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 product in accordance with the terms and conditions of the Hedrin
Supply Agreement, we may obtain products from an alternative supplier subject
to
certain conditions. The term of the Hedrin Supply Agreement ends upon
termination of the Hedrin License Agreement.
Topical
PTH (1-34)
Through
our April 2005 acquisition of Tarpan Therapeutics, Inc., or Tarpan, we acquired
a sublicense agreement with IGI, Inc. dated April 14, 2004. Under the IGI
sublicense agreement we hold the exclusive, world-wide, royalty bearing
sublicense to develop and commercialize the licensed technology. Under the
terms
of the IGI sublicense agreement, we are responsible for the cost of the
nonclinical and clinical development of the project, including research and
development, manufacturing, laboratory and clinical testing and trials and
marketing of licensed products.
The
IGI
sublicense agreement requires us to make certain milestone payments as follows:
$300,000 payable upon the commencement of a Phase 2 clinical trial; $500,000
upon the commencement of a Phase 3 clinical trial; $1,500,000 upon the
acceptance of an NDA application by the FDA; $2,400,000 upon the approval of
an
NDA by the FDA; $500,000 upon the commencement of a Phase 3 clinical trial
for
an indication other than psoriasis; $1,500,000 upon the acceptance of and NDA
application for an indication other than psoriasis by the FDA; and $2,400,000
upon the approval of an NDA for an indication other than psoriasis by the
FDA.
During
2007, we achieved the milestone of the commencement of Phase 2 clinical trial.
As a result $300,000 became payable to IGI. This $300,000 is included in
research and development expense for the year ended December 31, 2007. Payment
was made to IGI in February 2008.
In
addition, we are obligated to pay IGI, Inc. an annual royalty of 6% on annual
net sales up to $200,000,000. In any calendar year in which net sales exceed
$200,000,000, we are obligated to pay IGI, Inc. an annual royalty of 9% on
such
excess. Through March 31, 2008, sales have not commenced, therefore, we have
not
paid any such royalties.
IGI,
Inc.
may terminate the agreement (i) upon 60 days’ notice if we fail to make any
required milestone or royalty payments, or (ii) if we become bankrupt or if
a
petition in bankruptcy is filed, or if we are placed in the hands of a receiver
or trustee for the benefit of creditors. IGI, Inc. may terminate the agreement
upon 60 days’ written notice and an opportunity to cure in the event we commit a
material breach or default. Eighteen months from the date of the IGI sublicense
agreement, we may terminate the agreement in whole or as to any portion of
the
PTH patent rights upon 90 days’ notice to IGI, Inc.
28
Altoderm
On
April
3, 2007, we entered into a license agreement for “Altoderm,” with T&R.
Pursuant to the Altoderm license agreement, we acquired an exclusive North
American license to certain patent rights and other intellectual property
relating to Altoderm, a topical skin lotion product candidate with the active
ingredient cromolyn sodium (also known as sodium cromoglicate) for the treatment
of atopic dermatitis. In accordance with the terms of the Altoderm license
agreement, we issued 125,000 shares of our 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,
we 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 our common stock upon the achievement of
various clinical and regulatory milestones as follows: $450,000 upon acceptance
by the FDA of an IND; 125,000 shares of our common stock upon the first dosing
of a patient in the first Phase 2 clinical trial; 250,000 shares of our common
stock and $625,000 upon the first dosing of a patient in the first Phase 3
clinical trial; $1,000,000 upon the achievement of a successful outcome of
a
Phase 3 clinical trial; $1,100,000 upon the acceptance for filing of an NDA
application by the FDA; 500,000 shares of our common stock and $2,000,000 upon
the final approval of an NDA by the FDA; and $500,000 upon receipt of marketing
authorization in Canada.
In
addition, we are obligated to pay T&R an annual royalty of 10% on annual net
sales of up to $100,000,000; 15% of the amount of annual net sales in excess
of
$100,000,000 and 20% of annual net sales in excess of $200,000,000. There is
a
minimum royalty of $1,000,000 per year. There is a one-time success fee of
$10,000,000 upon the achievement of cumulative net sales of $100,000,000.
Through March 31, 2008, none of the milestones have been reached and sales
have
not commenced, therefore, we have not paid any such milestones or
royalties.
Altolyn
On
April
3, 2007, we and T&R also entered into a license agreement for Altolyn.
Pursuant to the Altolyn license agreement, we acquired an exclusive North
American license to certain patent rights and other intellectual property
relating to Altolyn, an oral formulation product candidate using cromolyn sodium
for the treatment of mastocytosis, food allergies, and inflammatory bowel
disorder. In accordance with the terms of the Altolyn license agreement, we
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,
we 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 upon the achievement of various clinical and regulatory milestones.
as follows: $450,000 upon acceptance for filing by the FDA of an IND; $625,000
upon the first dosing of a patient in the first Phase 3 clinical trial;
$1,000,000 upon the achievement of a successful outcome of a Phase 3 clinical
trial; $1,100,000 upon the acceptance for filing of an NDA application by the
FDA; $2,000,000 upon the final approval of an NDA by the FDA; and $500,000
upon
receipt of marketing authorization in Canada.
In
addition, we are obligated to pay T&R an annual royalty of 10% on annual net
sales of up to $100,000,000; 15% of the amount of annual net sales in excess
of
$100,000,000 and 20% of annual net sales in excess of $200,000,000. There is
a
minimum royalty of $1,000,000 per year. There is a one-time success fee of
$10,000,000 upon the achievement of cumulative net sales of
$100,000,000.
Through
March 31, 2008, none of the milestones have been reached and sales have not
commenced, therefore, we have not paid any such milestones or
royalties.
29
Summary
of Contractual Commitments
Employment
Agreements
The
Company has employment agreements with two employees for the payment of
aggregate annual base salaries of $655,000 as well as performance based bonuses.
These agreements have a remaining term of one year for one of the employees,
and
15 months for the second employee, and have a total remaining obligation under
these agreements of $738,000 as of March 31, 2008.
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
March 31, 2008, 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 March 31, 2008, 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.
We
currently do not have sufficient capital to fund our anticipated 2008
expenditures, and 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.
30
Research
and Development Projects
Hedrin
In
collaboration with Nordic and through the Hedrin JV we are developing Hedrin
for
the treatment of pediculosis (head lice). To date, Hedrin has been clinically
studied in 326 subjects and is currently marketed as a device in Western Europe
and as a pharmaceutical in the United Kingdom.
In
a
randomized, controlled, equivalence clinical study conducted in Europe by
T&R, Hedrin was administered to 253 adult and child subjects with head louse
infestation. The study results, published in the British Medical Journal in
June
2005, demonstrated Hedrin’s equivalence when compared to the insecticide
treatment, phenothrin, the most widely used pediculicide in the United Kingdom.
In addition, according to the same study, the Hedrin-treated subjects
experienced significantly less irritation (2%) than those treated with
phenothrin (9%).
An
additional clinical study published in the November 2007 issue of PLoS One,
an
international, peer-reviewed journal published by the Public Library of Science
(PLoS), demonstrated Hedrin’s superior efficacy compared to a United Kingdom
formulation of malathion, a widely used insecticide treatment in both Europe
and
North America. In this randomized, controlled, assessor blinded, parallel group
clinical trial, 73 adult and child subjects with head lice infestations were
treated with Hedrin or malathion liquid. Using intent-to-treat analysis, Hedrin
achieved a statistically significant cure rate of 70% compared to 33% with
malathion liquid. Using the per-protocol analysis Hedrin achieved a highly
statistically significant cure rate of 77% compared to 35% with malathion.
In
Europe it has been widely documented that head lice had become resistant to
European formulations of malathion, and we believe this resistance had
influenced these study results. To date, there have been no reports of
resistance to U.S. formulations of malathion. Additionally, Hedrin treated
subjects experienced no irritant reactions, and Hedrin showed clinical
equivalence to malathion in its ability to inhibit egg hatching. Overall,
investigators and study subjects rated Hedrin as less odorous, easier to apply,
and easier to wash out, and 97% of Hedrin treated subjects stated they were
significantly more inclined to use the product again versus 31% of those using
malathion.
In
the
United States, we are pursuing the development of Hedrin as a medical device.
We
expect to be required to complete at least one clinical trial with this product
candidate.
As
of
March 31, 2008, we have incurred $1,079,000 of project costs for the development
of Hedrin. $9,000 of such costs were incurred during the quarter ended March
31,
2008.
Topical
PTH (1-34).
We
are
developing Topical PTH (1-34) as a topical treatment for psoriasis. In August
2003, researchers, led by Michael Holick, Ph.D., MD, Professor of Medicine,
Physiology, and Biophysics at Boston University Medical Center, reported
positive results from a US Phase 1/2 clinical trial evaluating the safety and
efficacy of Topical PTH (1-34) as a topical treatment for psoriasis. This
double-blind, placebo controlled trial in 15 patients compared Topical PTH
(1-34) formulated in the Novasome® Technology versus the Novasome® vehicle
alone. Following 8 weeks of treatment, the topical application of Topical 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
into an open label extension study in which the Psoriasis Area and Severity
Index, or 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 a safe and effective treatment for plaque psoriasis
with no patients experiencing any clinically significant adverse
events.
31
Due
to
the high response rate seen in patients in the initial trial with Topical PTH
(1-34) we believe that it may have an important clinical advantage over current
topical psoriasis treatments. A follow on physician IND Phase 2a trial involving
Topical PTH (1-34) was initiated in December 2005 under the auspices of Boston
University. In April 2006, we reported a delay in its planned Phase 2a clinical
study of Topical PTH (1-34) due to a formulation issue. We believe that we
have
resolved this issue through a new gel formulation of Topical PTH (1-34) and
have
filed new patent applications in the U.S. for this new proprietary
formulation.
In
September 2007, the U.S. FDA accepted our corporate Investigational New Drug
(IND) application for this new gel formulation of Topical PTH (1-34), and in
October 2007, we initiated and began dosing subjects in a phase 2a clinical
study of Topical PTH (1-34) for the treatment of psoriasis. This U.S.
multi-center, randomized, double-blind, vehicle-controlled, parallel group
study
is desiged to evaluate safety and preliminary efficacy of Topical PTH (1-34)
for
the treatment of psoriasis. 61 subjects have been enrolled and randomized to
receive one of two dose levels of Topical PTH (1-34), or vehicle, for an 8
week
treatment period. In this study the vehicle is the topical formulation without
the active ingredient, PTH (1-34).
As
of
March 31, 2008, we have incurred $5,801,000 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. During the
first
quarter of 2008, we incurred $679,000 of these costs.
As
with
the development of our other product candidates, we do not currently have
sufficient capital to fund our planned development activities of Topical PTH
(1-34) beyond the ongoing phase 2a trial. We will, therefore, need to raise
additional capital in order to complete our planned R&D activities for
Topical PTH (1-34) . To the extent additional capital is not available when
we
need it, we may be forced to sublicense our rights to Topical PTH (1-34) or
abandon our development efforts altogether, either of which would have a
material adverse effect on the prospects of our business.
Since
PTH
(1-34) is already available in the injectable form, we should be able to utilize
much of the data that is publicly available in planning our future studies.
However, since PTH (1-34) will be used topically, bridging studies will need
to
be performed and we are not able to realistically predict the size and the
design of those studies at this time.
Altoderm
We
are
developing Altoderm for the pruritis (itch) associated with dermatologic
conditions including atopic dermatitis. In a Phase 3, randomized, double-blind,
placebo-controlled, parallel-group, clinical study (conducted in Europe by
T&R.) the compound was administered for 12 weeks to 114 subjects with
moderately severe atopic dermatitis. The placebo (vehicle) used in this study
was the Altoderm product without the active ingredient. In the study results,
published in the British Journal of Dermatology in February 2005, Altoderm
demonstrated a statistically significant reduction (36%) in atopic dermatitis
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 35% reduction in
the
use of topical steroids for the Altoderm treated subjects. Further analysis
of
the clinical data, performed by us showed that Altoderm treated subjects also
experienced a 57% reduction in pruritus.
32
Altoderm
is currently being tested in a second, ongoing Phase 3, randomized,
double-blind, vehicle-controlled clinical study (also conducted in Europe by
T&R). Analysis of the preliminary data from the initial 12 week, blinded
portion of this clinical trial has been completed. The vehicle used in this
study was the Altoderm product without the active ingredient, cromolyn sodium.
The preliminary data indicate Altoderm was safe and well tolerated, and showed
a
trend toward improvement in pruritus, 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. We believe these outcomes were
due to suboptimal study design where subjects were unrestricted in their use
of
concomitant therapies such as topical steroids and immunomodulators. The placebo
(vehicle) used in this study was the Altoderm product without the active
ingredient, cromolyn sodium. Analysis of the preliminary open label data
beginning at week 13 of the study, show vehicle treated subjects demonstrating
further improvement when switched to Altoderm. 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 we and Thornton & Ross
Limited believe there is significant potential for Altoderm and will continue
development of this product candidate.
On
March
6, 2008, we announced we had successfully completed a pre-IND meeting with
the
FDA. Based on a review of the submitted package for Altoderm, including data
from the two previously reported Phase 3 clinical studies, the FDA determined
that following completion of certain nonclinical studies, and the acceptance
of
an IND, Phase 2 clinical studies may be initiated in the U.S. The FDA also
concurred that the proposed indication of pruritus associated with dermatologic
conditions including atopic dermatitis can be pursued.
As
of
March 31, 2008, we have incurred $1,091,000 for the development of Altoderm.
We
incurred $79,000 of such costs during the quarter ended March 31,
2008.
Altolyn
We
are
developing Altolyn for the treatment of mastocystosis. On March 6, 2008, we
announced we had successfully completed a pre-IND meeting with the FDA. Based
on
a review of the submitted package for Altolyn, the FDA concurred that the
proposed indication of mastocytosis can be pursued and that the 505(b)(2) NDA
would be an acceptable approach provided a clinical bridge is established
between Altolyn and Gastrocrom®,
the
oral liquid formulation of cromolyn sodium currently approved in the U.S. to
treat mastocytosis. The FDA also affirmed that a single, Phase 3 study
demonstrating the efficacy of Altolyn over placebo, may be sufficient to support
a product approval in the U.S. In addition, the FDA also concurs that no
additional nonclinical studies will be required to support an IND application.
We are working with T&R and the current United Kingdom manufacturer of
Altolyn to develop a GMP compliant manufacturing process.
Early
clinical experience with Altolyn in the United Kingdom. suggests promising
activity in patients with various allergic disorders, including food allergy
and
inflammatory bowel conditions. We may pursue these as additional
indications.
As
of
March 31, 2008, we have incurred $823,000 for the development of Altolyn. We
incurred $33,000 of such costs during the quarter ended March 31,
2008.
33
Off-Balance
Sheet Arrangements
We
have
not entered into any off-balance sheet arrangements.
New
Accounting Pronouncements
In
March
2008, the FASB issued SFAS No. 161 "Disclosures About Derivative Instruments
and
Hedging Activities - an amendment of FASB Statement No. 133" ("SFAS 161").
SFAS
161 amends SFAS 133 by requiring expanded disclosures about an entity's
derivative instruments and hedging activities. SFAS 161 requires qualitative
disclosures about objectives and strategies for using derivatives, quantitative
disclosures about fair value amounts of and gains and losses on derivative
instruments, and disclosures about credit-risk-related contingent features
in
derivative instruments. SFAS 161 is effective for the Company as of January
1,
2009. The Company does not believe that SFAS 161 will have any impact on its
consolidated financial statements.
34
Item
3. Quantitative and Qualitative Disclosure About Market
Risk
Our
exposure to market risk is confined to our cash and cash equivalents. We have
attempted to minimize risk by investing in high-quality financial instruments,
primarily money market funds with no security having an effective duration
longer than 90 days. If the market interest rate decreases by 100 basis points
or 1%, the fair value of our cash and cash equivalents portfolio would have
minimal to no impact on the carrying value of our portfolio. We did not hold
any
derivative instruments as of March 31, 2008, and we have never held such
instruments in the past.
Item
4.
Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
As
of
March 31, 2008, we carried out an evaluation, under the supervision and with
the
participation of our Chief Executive Officer and Chief Financial Officer, of
the
effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities
Exchange Act of 1934, as amended). Based upon that evaluation, our Chief
Executive Officer and Chief Financial Officer concluded that our disclosure
controls and procedures as of that date were effective to ensure that
information required to be disclosed in the reports we file under the Securities
and Exchange Act is recorded, processed, summarized and reported on an accurate
and timely basis.
The
Company’s management, including its Chief Executive Officer and its Chief
Financial Officer, does not expect that disclosure controls or internal controls
over financial reporting will prevent all errors or all instances of fraud,
even
as the same are improved to address any deficiencies. The design of any system
of controls is based in part upon certain assumptions about the likelihood
of
future events, and there can be no assurance that any design will succeed in
achieving its stated goals under all potential future conditions. A control
system, no matter how well designed and operated, can provide only reasonable,
not absolute, assurance that the control system’s objectives will be met. Over
time, controls may become inadequate because of changes in conditions or
deterioration in the degree of compliance with policies or procedures. Further,
the design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their
costs. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that all control issues and instances
of fraud, if any, within the Company have been detected.
Because
of the inherent limitation of a cost-effective control system, misstatements
due
to error or fraud may occur and not be detected. These inherent limitations
include the realities that judgments in decision-making can be faulty, and
that
breakdowns can occur because of a simple error or mistake. Controls can also
be
circumvented by the individual acts of some persons, by collusion of two or
more
people, or by management override of the controls.
Changes
in Internal Control
During
the quarter ended March 31, 2008, 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.
35
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
Swiss
Pharma Contract LTD, or Swiss Pharma, a clinical site that we used in one of
its
obesity trials, gave notice to us 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 us 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 we do not believe that
Swiss Pharma is entitled to additional payments and has not accrued any of
these
costs as of December 31, 2007. The contract between us and Swiss Pharma provides
for arbitration in the event of a dispute, such as this claim for an additional
payment. On March 10, 2008, Swiss Pharma filed for arbitration with the Swiss
Chamber of Commerce. As we do not believe that Swiss Pharma is entitled to
additional payments, we intend to defend our position in arbitration. On April
2, 2008, we filed our statement of defense and counterclaim for recovery of
costs incurred by us as a result of Swiss Pharma’s failure to meet agreed upon
deadlines under our contract.
Item
1A. Risk Factors
We
have
not had material changes to our risk factor disclosure in our Annual Report
on
Form 10-K for the year ended December 31, 2007 under the caption “Risk Factors”
following Item 1 of such report.
Item
6. Exhibits
Exhibit
No.
|
Description
|
31.1
|
Certification
of Chief Executive Officer
|
31.2
|
Certification
of Chief Financial Officer
|
32.1
|
Certifications
of Chief Executive Officer and Chief Financial Officer pursuant to
Section
906 of the Sarbanes-Oxley Act of
2002.
|
36
SIGNATURES
In
accordance with the requirements of the Exchange Act of 1934, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto
duly
authorized.
MANHATTAN
PHARMACEUTICALS, INC.
|
|
Date:
May 20, 2008
|
By:
/s/ Douglas Abel
|
|
Douglas
Abel
|
President
and Chief Executive Officer
|
|
Date:
May 20, 2008
|
By:
/s/ Michael G. McGuinness
|
Michael
G. McGuinness
|
|
Chief
Financial Officer
|
37
Index
to Exhibits Filed with this Report
Exhibit
No.
|
Description
|
31.1
|
Certification
of Chief Executive Officer
|
31.2
|
Certification
of Chief Financial Officer
|
32.1
|
Certifications
of Chief Executive Officer and Chief Financial Officer pursuant to
Section
906 of the Sarbanes-Oxley Act of
2002.
|
38