Delaware
|
001-32639
|
36-3898269
|
||
(State
or other jurisdiction
of
incorporation)
|
(Commission
File
Number)
|
(IRS
Employer
Identification
No.)
|
¨
|
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
¨
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
¨
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
¨
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
|
|
·
|
Upon
the affirmative decision of the Company’ Board of Directors, provided that
such decision is made prior to March 8, 2011, to further develop the
AST-914 metabolite product candidate, either internally or through a
corporate partnership, the Company would issue 8,828,029 of the Milestone
Shares.
|
|
·
|
Upon
the acceptance by the FDA of the Company's filing of the first New Drug
Application for the AST-726 product candidate, the Company would issue
7,062,423 of the Milestone Shares.
|
|
·
|
Upon
the Company receiving FDA approval to market the AST-726 product candidate
in the United States of America, the Company would issue 8,828,029 of the
Milestone Shares.
|
(d)
|
Exhibits
|
|
23.1
|
Consent
of Independent Registered Public Accounting
Firm.
|
|
99.1
|
Audited
consolidated financial statements at and for the years ended December 31,
2009 and 2008.
|
|
99.2
|
Unaudited
pro forma condensed financial information for the year ended December 31,
2009.
|
MANHATTAN
PHARMACEUTICALS, INC.
|
||
Date: May 24,
2010
|
By:
|
/s/ Michael G.
McGuinness
|
Michael
G. McGuinness
|
||
Chief
Operating and Financial
Officer
|
Exhibit No.
|
Description
|
|
23.1
|
Consent
of Independent Registered Public Accounting Firm.
|
|
99.1
|
Audited
consolidated financial statements at and for the years ended December 31,
2009 and 2008.
|
|
99.2
|
Unaudited
pro forma condensed financial information for the year ended December 31,
2009.
|
Page
|
|
Report
of Independent Registered Public Accounting Firm
|
2
|
Consolidated
Balance Sheets
|
|
December
31, 2009 and 2008
|
3
|
Consolidated
Statements of Operations
|
|
Years
ended December 31, 2009 and 2008 and Period from
|
|
May
8, 2003 (Inception) to December 31, 2009
|
4
|
Consolidated
Statement of Changes in Stockholders' Equity (Deficiency)
|
|
Period
from May 8, 2003 (Inception) to December 31, 2009
|
5 -
6
|
Consolidated
Statements of Cash Flows
|
|
Years
ended December 31, 2009 and 2008 and Period
|
|
from
May 8, 2003 (Inception) to December 31, 2009
|
7
|
Notes
to Consolidated Financial Statements
|
8 -
16
|
December
31,
2009
|
December
31,
2008
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 592,364 | $ | 1,019,380 | ||||
Note
receivable
|
27,000 | - | ||||||
Prepaid
expenses
|
- | 16,124 | ||||||
Total
current assets
|
619,364 | 1,035,504 | ||||||
Office
equipment, net of accumulated depreciation of $32,174 and
$35,585
|
9,118 | 15,920 | ||||||
Other
assets
|
120,932 | 88,075 | ||||||
Total
assets
|
$ | 749,414 | $ | 1,139,499 | ||||
LIABILITIES
AND STOCKHOLDERS’ DEFICIENCY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 1,459,128 | $ | 1,147,350 | ||||
Senior
convertible notes
|
5,000,000 | 5,000,000 | ||||||
Interest
payable – senior convertible notes
|
1,849,116 | 1,175,343 | ||||||
Senior
notes
|
6,500,000 | 6,500,000 | ||||||
Interest
payable – senior notes
|
1,961,735 | 1,130,697 | ||||||
Note
payable – related party
|
117,376 | 117,376 | ||||||
Interest
payable – related party
|
24,566 | 18,697 | ||||||
Total
current liabilities
|
16,911,921 | 15,089,463 | ||||||
Commitments
|
||||||||
Stockholders’
deficiency:
|
||||||||
Preferred
stock, $.001 par value; 6,000,000 shares authorized; none
issued
|
- | - | ||||||
Common
stock, $.001 par value; 20,000,000 shares authorized; 4,464,291 shares
issued and outstanding
|
4,464 | 4,464 | ||||||
Additional
paid-in capital
|
23,860,768 | 23,860,768 | ||||||
Deficit
accumulated during the development stage
|
(40,027,739 | ) | (37,815,196 | ) | ||||
Total
stockholders’ deficiency
|
(16,162,507 | ) | (13,949,964 | ) | ||||
Total
liabilities and stockholders’ deficiency
|
$ | 749,414 | $ | 1,139,499 |
Year Ended
December 31,
2009
|
Year Ended
December 31,
2008
|
Period from
May 8, 2003
(Inception) to
December 31,
2009
|
||||||||||
Operating
expenses:
|
||||||||||||
Research
and development
|
$ | 577,175 | $ | 1,946,953 | $ | 11,173,562 | ||||||
In-process
research and development
|
- | - | 8,983,339 | |||||||||
General
and administrative
|
127,396 | 790,895 | 6,091,684 | |||||||||
Loss
from operations
|
(704,571 | ) | (2,737,848 | ) | (26,248,585 | ) | ||||||
Interest
and other income
|
2,708 | 53,517 | 372,257 | |||||||||
Interest
expense, including amortization of debt discount and deferred financing
costs
|
(1,510,680 | ) | (1,809,246 | ) | (14,151,411 | ) | ||||||
Net
loss
|
$ | (2,212,543 | ) | $ | (4,493,577 | ) | $ | (40,027,739 | ) | |||
Basic
and diluted net loss per common share
|
$ | (.50 | ) | $ | (1.01 | ) | ||||||
Weighted
average common shares outstanding – basic and diluted
|
4,464,291 | 4,464,291 |
Deficit
|
||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||
Stock
|
Additional
|
During the
|
||||||||||||||||||||||
Common Stock
|
Subscription
|
Paid-in
|
Development
|
|||||||||||||||||||||
Shares
|
Amount
|
Receivable
|
Capital
|
Stage
|
Total
|
|||||||||||||||||||
Issuance
of common stock to investor at $.81 per share
|
1,233,333 | $ | 1,233 | $ | 998,767 | $ | 1,000,000 | |||||||||||||||||
Issuance
of common stock pursuant to license agreement at $.81 per
share
|
100,000 | 100 | 80,900 | 81,000 | ||||||||||||||||||||
Issuance
of common stock pursuant to consulting agreement for services rendered at
$.81 per share
|
33,333 | 33 | (33 | ) | - | |||||||||||||||||||
Issuance
of common stock to officer at $.81 per share
|
95,666 | 96 | $ | (287 | ) | 191 | - | |||||||||||||||||
Stock-based
compensation
|
13,110 | 13,110 | ||||||||||||||||||||||
Net
loss
|
$ | (224,532 | ) | (224,532 | ) | |||||||||||||||||||
Balance,
at December 31, 2003
|
1,462,332 | 1,462 | (287 | ) | 1,092,935 | (224,532 | ) | 869,578 | ||||||||||||||||
Payment
received for stock subscription by officer
|
287 | 287 | ||||||||||||||||||||||
Issuance
of common stock to investor at $3.00 per share
|
1,333,333 | 1,333 | 3,998,667 | 4,000,000 | ||||||||||||||||||||
Stock-based
compensation
|
230,513 | 230,513 | ||||||||||||||||||||||
Net
loss
|
(2,029,219 | ) | (2,029,219 | ) | ||||||||||||||||||||
Balance,
at December 31, 2004
|
2,795,665 | 2,795 | - | 5,322,115 | (2,253,751 | ) | 3,071,159 | |||||||||||||||||
Stock-based
compensation
|
195,959 | 195,959 | ||||||||||||||||||||||
Net
loss
|
(3,842,861 | ) | (3,842,861 | ) | ||||||||||||||||||||
Balance,
at December 31, 2005
|
2,795,665 | 2,795 | - | 5,518,074 | (6,096,612 | ) | (575,743 | ) |
Deficit
|
||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||
Stock
|
Additional
|
During the
|
||||||||||||||||||||||
Common Stock
|
Subscription
|
Paid-in
|
Development
|
|||||||||||||||||||||
Shares
|
Amount
|
Receivable
|
Capital
|
Stage
|
Total
|
|||||||||||||||||||
Balance,
at December 31, 2005 (carried forward)
|
2,795,665 | $ | 2,795 | $ | - | $ | 5,518,074 | $ | (6,096,612 | ) | $ | (575,743 | ) | |||||||||||
Issuance
of common stock in connection with the merger with Pyrenees at $5.27 per
share
|
1,666,626 | 1,667 | 8,781,452 | 8,783,119 | ||||||||||||||||||||
Warrants
issued to placement agent in connection with senior convertible
notes
|
339,382 | 339,382 | ||||||||||||||||||||||
Debt
discount on senior convertible notes
|
1,187,841 | 1,187,841 | ||||||||||||||||||||||
Stock-based
compensation
|
158,948 | 158,948 | ||||||||||||||||||||||
Net
loss
|
(14,653,787 | ) | (14,653,787 | ) | ||||||||||||||||||||
Balance,
at December 31, 2006
|
4,462,291 | 4,462 | - | 15,985,697 | (20,750,399 | ) | (4,760,240 | ) | ||||||||||||||||
Debt
discount related to an extension of the term of the senior convertible
notes and additional warrant coverage
|
1,484,504 | 1,484,504 | ||||||||||||||||||||||
Debt
discount on senior notes
|
5,761,050 | 5,761,050 | ||||||||||||||||||||||
Warrants
issued to placement agent in connection with senior notes
|
576,105 | 576,105 | ||||||||||||||||||||||
Stock-based
compensation
|
43,590 | 43,590 | ||||||||||||||||||||||
Net
loss
|
(12,571,220 | ) | (12,571,220 | ) | ||||||||||||||||||||
Balance,
at December 31, 2007
|
4,462,291 | 4,462 | - | 23,850,946 | (33,321,619 | ) | (9,466,211 | ) | ||||||||||||||||
Options
exercise
|
2,000 | 2 | 5,998 | 6,000 | ||||||||||||||||||||
Stock-based
compensation
|
3,824 | 3,824 | ||||||||||||||||||||||
Net
loss
|
(4,493,577 | ) | (4,493,577 | ) | ||||||||||||||||||||
Balance,
at December 31, 2008
|
4,464,291 | 4,464 | - | 23,860,768 | (37,815,196 | ) | (13,949,964 | ) | ||||||||||||||||
Net
loss
|
(2,212,543 | ) | (2,212,543 | ) | ||||||||||||||||||||
Balance,
at December 31, 2009
|
4,464,291 | $ | 4,464 | $ | - | $ | 23,860,768 | $ | (40,027,739 | ) | $ | (16,162,507 | ) |
Year ended
December
31, 2009
|
Year ended
December
31, 2008
|
Period from
May 8, 2003
(Inception) to
December 31,
2009
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (2,212,543 | ) | $ | (4,493,577 | ) | $ | (40,027,739 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Stock-based
compensation
|
- | 3,824 | 645,944 | |||||||||
Common
stock issued in connection with license agreement
|
- | - | 81,000 | |||||||||
Charge
for in-process research and development
|
- | - | 8,983,339 | |||||||||
Amortization
of debt discount
|
- | 404,865 | 8,433,395 | |||||||||
Amortization
of deferred financing
|
- | - | 1,870,302 | |||||||||
Other
|
(235 | ) | (341 | ) | ||||||||
Depreciation
|
6,037 | 9,812 | 41,533 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses
|
16,124 | 18,691 | - | |||||||||
Other
current assets
|
- | - | (67,326 | ) | ||||||||
Other
assets
|
(32,856 | ) | - | (120,932 | ) | |||||||
Accounts
payable and accrued expenses
|
311,777 | (219,721 | ) | 1,459,127 | ||||||||
Interest
payable – senior convertible notes
|
673,773 | 611,593 | 1,849,116 | |||||||||
Interest
payable – senior debt
|
831,038 | 786,919 | 1,961,735 | |||||||||
Interest
payable – related party
|
5,869 | 5,869 | 22,986 | |||||||||
Net
cash used in operating activities
|
(401,016 | ) | (2,871,725 | ) | (14,867,861 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Purchase
of office and computer equipment
|
- | (4,889 | ) | (51,415 | ) | |||||||
Cash
acquired in merger
|
- | - | 4,191 | |||||||||
Note
receivable
|
(27,000 | ) | (27,000 | ) | ||||||||
Cash
from sale of fixed assets
|
1,000 | - | 1,000 | |||||||||
Net
cash used in investing activities
|
(26,000 | ) | (4,889 | ) | (73,224 | ) | ||||||
Cash
flows from financing activities:
|
||||||||||||
Net
proceeds received from senior convertible notes
|
- | - | 4,641,000 | |||||||||
Net
proceeds received from senior debt
|
- | - | 5,990,000 | |||||||||
Payments
for deferred financing costs
|
- | - | (103,838 | ) | ||||||||
Proceeds
from issuance of common stock
|
- | 6,000 | 5,006,287 | |||||||||
Net
cash provided by financing activities
|
- | 6,000 | 15,533,449 | |||||||||
Net
increase (decrease) in cash and cash equivalents
|
(427,016 | ) | (2,870,614 | ) | 592,364 | |||||||
Beginning
of period
|
1,019,380 | 3,889,994 | - | |||||||||
End
of period
|
$ | 592,364 | $ | 1,019,380 | $ | 592,364 | ||||||
Supplemental
schedule of noncash investing and
financing activities:
|
||||||||||||
Debt
assumed in merger with Pyrenees
|
$ | - | $ | - | $ | 117,482 | ||||||
Interest
payable assumed in merger with Pyrenees
|
$ | - | $ | - | $ | 1,580 | ||||||
Warrants
issued to placement agent
|
$ | - | $ | - | $ | 915,487 | ||||||
Debt
discount
|
$ | - | $ | - | $ | 8,433,395 |
Note
1 -
|
Organization,
Business and Basis of Presentation:
|
2009
|
2008
|
|||||||
Net
operating loss carryforwards – Federal
|
$ | 7,688,000 | $ | 6,935,000 | ||||
Net
operating loss carryforwards - State
|
1,356,000 | 1,224,000 | ||||||
Totals
|
9,044,000 | 8,159,000 | ||||||
Less
valuation allowance
|
(9,044,000 | ) | (8,159,000 | ) | ||||
Deferred
tax assets
|
$ | - | $ | - |
December
31,
|
||||||||
2009
|
2008
|
|||||||
Statutory
federal tax rate
|
(34.0 | )% | (34.0 | )% | ||||
State
income tax rate (net of federal)
|
(6.0 | )% | (6.0 | )% | ||||
Debt
discount amortization
|
- | % | 2.0 | % | ||||
Effect
of valuation allowance
|
40.0 | % | 38.0 | % | ||||
Effective
tax rate
|
— | % | — | % |
2009
|
2008
|
|||||||||||||||
Shares
|
Weighted
Average
Exercise
Price
|
Shares
|
Weighted
Average
Exercise
Price
|
|||||||||||||
Outstanding
at beginning of year
|
285,999 | $ | 2.57 | 291,332 | $ | 2.31 | ||||||||||
Expired
|
- | $ | - | (3,333 | ) | $ | 3.00 | |||||||||
Exercised
|
- | $ | - | (2,000 | ) | $ | 3.00 | |||||||||
Granted
|
- | $ | - | - | $ | - | ||||||||||
Outstanding
at end of year
|
285,999 | $ | 285,999 | $ | ||||||||||||
Options
exercisable at year – end
|
285,999 | $ | 2.57 | 285,999 | $ | 2.57 |
|
·
|
Upon
the affirmative decision of the Company’ Board of Directors, provided that
such decision is made prior to March 8, 2011, to further develop the
AST-914 metabolite product candidate (now called AST-915), either
internally or through a corporate partnership, the Company would issue
8,828,029 of the Milestone Shares.
|
|
·
|
Upon
the acceptance by the FDA of the Company's filing of the first New Drug
Application for the AST-726 product candidate, the Company would issue
7,062,423 of the Milestone Shares.
|
|
·
|
Upon
the Company receiving FDA approval to market the AST-726 product candidate
in the United States of America, the Company would issue 8,828,029 of the
Milestone Shares.
|
Historical
|
Pro
forma
|
Pro
forma
|
|||||||||||||||
Manhattan
|
Ariston
|
adjustments
|
Notes
|
combined
|
|||||||||||||
Revenue
|
- | - | - | ||||||||||||||
Costs
and expenses:
|
|||||||||||||||||
Research
and development
|
40,376 | 577,175 | 617,551 | ||||||||||||||
General
and administrative
|
1,731,182 | 127,396 | (6,037 | ) |
A
|
1,852,541 | |||||||||||
Total
operating expenses
|
1,771,558 | 704,571 | (6,037 | ) | 2,470,092 | ||||||||||||
Operating
loss
|
(1,771,558 | ) | (704,571 | ) | 6,037 | (2,470,092 | ) | ||||||||||
Other
(income) expense:
|
|||||||||||||||||
Equity
in loss of Hedrin JV
|
500,000 | 500,000 | |||||||||||||||
Interest
and other income
|
(586,697 | ) | (2,708 | ) | 9,118 |
A
|
(580,287 | ) | |||||||||
Change
in fair value of derivatives
|
560,065 | 560,065 | |||||||||||||||
Interest
and amortization expense
|
548,359 | 1,510,680 | 2,059,039 | ||||||||||||||
Total
other (income) expense
|
1,021,727 | 1,507,972 | 9,118 | 2,538,817 | |||||||||||||
Net
loss
|
(2,793,285 | ) | (2,212,543 | ) | (3,081 | ) | (5,008,909 | ) | |||||||||
Net
loss per common share:
|
|||||||||||||||||
Primary
and fully diluted
|
$ | (0.04 | ) | $ | (0.06 | ) | |||||||||||
Weighted
average shares of common stock Outstanding:
|
|||||||||||||||||
Primary
and fully diluted
|
70,624,232 | 7,062,423 |
B
|
77,686,655 |
1.
|
Basis
of Presentation
|
Valuation
|
||||
Cash
and cash equivalents
|
$ | 519,365 | ||
Other
assets
|
120,932 | |||
Total
identifiable assets
|
640,297 | |||
Accounts
payable and accrued expenses
|
(437,616 | ) | ||
Senior
convertible notes
|
(16,452,793 | ) | ||
Total
liabilities assumed
|
(16,890,409 | ) | ||
Net
identifiable assets acquired
|
(16,250,112 | ) | ||
In-process
R&D acquired
|
17,742,049 | |||
Net
assets acquired
|
$ | 1,491,937 |