x |
Annual
Report pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934 for the fiscal year ended December 31,
2007
|
o |
Transition
Report pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934 for the transition period from
___to___
|
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
(Address
of Principal Executive Offices)
|
10019
(Zip
Code)
|
Title
of each class
|
Name
of each exchange on which registered
|
Common
Stock, $0.001 par value
|
OTC
Bulletin Board
|
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o (Do not check if
a smaller reporting company)
|
Smaller
reporting company x
|
Page
|
||
PART
I
|
||
Item
1
|
Business
|
2
|
Item
1A
|
Risk
Factors
|
17
|
Item
2
|
Legal
Proceedings
|
27
|
Item
3
|
Properties
|
27
|
Item
4
|
Submission
of Matters to a Vote of Security Holders
|
27
|
PART
II
|
||
Item
5
|
Market
for Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
28
|
Item
6
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
29
|
Item
7
|
Financial
Statements and Supplementary Data
|
45
|
Item
8
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
45
|
Item
8A(T)
|
Controls
and Procedures
|
45
|
Item
8B
|
Other
Information
|
46
|
PART
III
|
||
Item
9
|
Directors,
Executive Officers and Corporate Governance
|
46
|
Item
10
|
Executive
Compensation
|
47
|
Item
11
|
Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters
|
47
|
Item
12
|
Certain
Relationships and Related Transactions, and Director
Independence
|
47
|
PART
IV
|
||
Item
13
|
Exhibits,
Financial Statement Schedules
|
48
|
Item
14
|
Principal
Accounting Fees and Services
|
51
|
Index
to Consolidated Financial Statements
|
F-1
|
·
|
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.
|
1.
|
U.S.
Patent Application No. 2007/0142330, entitled, “Method and composition for
the control of arthropods.” Jayne Ansell, Inventor. Application filed
February 12, 2007. This application is a divisional of U.S. application
Ser. No. 10/097,615, filed Mar. 15, 2002, which is a continuation
of
International Application No. PCT/GB00/03540, which designated
the United
States and was filed on Sep. 14, 2000. This application has not
yet issued
as a patent. Any patent that issues will expire on September14,
2020.
|
1.
|
U.S.
Patent No. 5,527,772, entitled “Regulation of cell proliferation and
differentiation using peptides.” M.F. Holick, Inventor. Application filed
July, 28, 1994. Patent issued June 18, 1996. This patent expires
June 18,
2013.
|
2.
|
U.S.
Patent No. 5,840,690, entitled “Regulation of cell proliferation and
differentation using peptides.” M.F. Holick, Inventor. Application filed
June 6, 1995. Patent issued November 24, 1998. This patent expires
June
18, 2013.
|
3.
|
U.S.
Provisional application No. US60/940,509, entitled “Topical Compositions
comprising a macromolecule and methods of using same.” Application was
filed on May 29, 2007.
|
1.
|
U.S.
Patent No. 7,109,246, entitled “Pharmaceutical compositions comprising an
amphoteric surfactant an alkoxylated cetyl alcohol and a polar
drug.”
Brian Hawtin, Inventor. Application filed May 20, 1999. Patent
issued
September 19, 2006. This patent expires on May 20,
2019.
|
2.
|
U.S.
Application Publication No. 2007/0036860, entitled “Treatment of allergic
conditions.” Alexander James Wigmore, Inventor. Any patent that issues
will expire on November 9, 2019. This patent covers both Altoderm
and
Altolyn.
|
1.
|
U.S.
Patent No. 7,258,872, entitled “Chromone enteric release formulation.”
Alexander James Wigmore, Inventor. Application filed November 9,
1999,
claiming the benefit of a GB application filed November 11, 1998.
Patent
issued August 21, 2007. The expected date of expiration, which
was
November 9, 2019, has been extended by 793 days (expiration date
Jan 10,
2022).
|
2.
|
U.S.
Application Publication No. 2007/0036860, entitled “Treatment of allergic
conditions.” Alexander James Wigmore, Inventor. Application filed October
13, 2006, claiming the benefit of a prior U.S. application, which
claimed
the benefit of a PCT application filed November 9, 1999. This application
has not yet issued as a patent. Any patent that issues is expected
to
expire on November 9, 2019. This patent covers both Altoderm and
Altolyn.
|
· |
nonclinical
laboratory tests, animal studies, and formulation
studies,
|
· |
submission
to the FDA of an IND for human clinical testing, which must become
effective before human clinical trials may
begin,
|
· |
adequate
and well-controlled human clinical trials to establish the safety
and
efficacy of the drug for each
indication,
|
· |
submission
to the FDA of an NDA,
|
· |
satisfactory
completion of an FDA inspection of the manufacturing facility or
facilities at which the drug is produced to assess compliance with
current
good manufacturing practices, or cGMPs,
and
|
· |
FDA
review and approval of the NDA.
|
· |
the
results of any clinical trials;
|
· |
the
scope and results of our research and development
programs;
|
· |
the
time required to obtain regulatory
approvals;
|
· |
our
ability to establish and maintain marketing alliances and collaborative
agreements; and
|
· |
the
cost of our internal marketing
activities.
|
· |
continue
to undertake nonclinical development and clinical trials for our
product
candidates;
|
· |
seek
regulatory approvals for our product
candidates;
|
· |
implement
additional internal systems and infrastructure;
|
· |
lease
additional or alternative office facilities;
and
|
· |
hire
additional personnel.
|
· |
continuing
to undertake nonclinical development and clinical
trials;
|
· |
participating
in regulatory approval processes;
|
· |
formulating
and manufacturing products; and
|
· |
conducting
sales and marketing activities.
|
· |
delay
commercialization of, and our ability to derive product revenues
from, our
product candidates;
|
· |
impose
costly procedures on us; and
|
· |
diminish
any competitive advantages that we may otherwise
enjoy.
|
· |
unforeseen
safety issues;
|
· |
determination
of dosing issues;
|
· |
lack
of effectiveness during clinical
trials;
|
· |
slower
than expected rates of patient
recruitment;
|
· |
inability
to monitor patients adequately during or after treatment;
and
|
· |
inability
or unwillingness of medical investigators to follow our clinical
protocols.
|
· |
perceptions
by members of the health care community, including physicians,
about the
safety and effectiveness of our
drugs;
|
· |
cost-effectiveness
of our product relative to competing
products;
|
· |
availability
of reimbursement for our products from government or other healthcare
payers; and
|
· |
effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any.
|
· |
We
may be unable to identify manufacturers on acceptable terms or
at all
because the number of potential manufacturers is limited and the
FDA must
approve any replacement contractor. This approval would require
new
testing and compliance inspections. In addition, a new manufacturer
would
have to be educated in, or develop substantially equivalent processes
for,
production of our products after receipt of FDA approval, if
any.
|
· |
Our
third-party manufacturers might be unable to formulate and manufacture
our
drugs in the volume and of the quality required to meet our clinical
needs
and commercial needs, if any.
|
· |
Our
future contract manufacturers may not perform as agreed or may
not remain
in the contract manufacturing business for the time required to
supply our
clinical trials or to successfully produce, store and distribute
our
products.
|
· |
Drug
manufacturers are subject to ongoing periodic unannounced inspection
by
the FDA, the Drug Enforcement Agency, and corresponding state agencies
to
ensure strict compliance with good manufacturing practice and other
government regulations and corresponding foreign standards. We
do not have
control over third-party manufacturers’ compliance with these regulations
and standards.
|
· |
If
any third-party manufacturer makes improvements in the manufacturing
process for our products, we may not own, or may have to share,
the
intellectual property rights to the
innovation.
|
· |
developing
drugs;
|
· |
undertaking
nonclinical testing and human clinical
trials;
|
· |
obtaining
FDA and other regulatory approvals of
drugs;
|
· |
formulating
and manufacturing drugs; and
|
· |
launching,
marketing and selling drugs.
|
· |
the
degree and range of protection any patents will afford us against
competitors including whether third parties will find ways to invalidate
or otherwise circumvent our
patents;
|
· |
if
and when patents will issue;
|
· |
whether
or not others will obtain patents claiming aspects similar to those
covered by our patents and patent applications;
or
|
· |
whether
we will need to initiate litigation or administrative proceedings
which
may be costly whether we win or
lose.
|
· |
obtain
licenses, which may not be available on commercially reasonable
terms, if
at all;
|
· |
redesign
our products or processes to avoid
infringement;
|
· |
stop
using the subject matter claimed in the patents held by
others;
|
· |
pay
damages; or
|
· |
defend
litigation or administrative proceedings which may be costly whether
we
win or lose, and which could result in a substantial diversion
of our
valuable management resources.
|
· |
government
and health administration
authorities;
|
· |
private
health maintenance organizations and health insurers;
and
|
· |
other
healthcare payers.
|
· |
publicity
regarding actual or potential clinical results relating to products
under
development by our competitors or
us;
|
· |
delay
or failure in initiating, completing or analyzing nonclinical or
clinical
trials or the unsatisfactory design or results of these
trials;
|
· |
achievement
or rejection of regulatory approvals by our competitors or
us;
|
· |
announcements
of technological innovations or new commercial products by our
competitors
or us;
|
· |
developments
concerning proprietary rights, including
patents;
|
· |
developments
concerning our collaborations;
|
· |
regulatory
developments in the United States and foreign
countries;
|
· |
economic
or other crises and other external factors;
|
· |
period-to-period
fluctuations in our revenues and other results of
operations;
|
· |
changes
in financial estimates by securities analysts;
and
|
· |
sales
of our common stock.
|
Nominee
|
Votes For
|
|
Votes Withheld
|
||||
Douglas
Abel
|
35,536,892
|
65,132
|
|||||
Neil
Herskowitz
|
35,376,093
|
225,931
|
|||||
Malcolm
Hoenlein
|
35,518,495
|
83,529
|
|||||
Timothy
McInerney
|
35,538,692
|
63,332
|
|||||
Joan
Pons Gimbert
|
35,154,378
|
447,646
|
|||||
Richard
I. Steinhart
|
35,529,736
|
72,288
|
|||||
Michael
Weiser
|
34,493,245
|
1,108,779
|
Price
Range
|
|||||||||||||
2007
|
2006
|
||||||||||||
Quarter
Ended
|
High
|
Low
|
High
|
Low
|
|||||||||
March
31
|
$
|
0.96
|
$
|
0.70
|
$
|
1.640
|
$
|
1.160
|
|||||
June
30
|
1.10
|
0.69
|
1.360
|
0.075
|
|||||||||
September
30
|
0.78
|
0.22
|
0.880
|
0.620
|
|||||||||
December
31
|
0.23
|
0.09
|
0.920
|
0.620
|
ITEM 6. |
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS.
|
|
Years ended December 31,
|
||||||||||||
2007
|
2006
|
Increase
(decrease) |
% Increase
(decrease) |
||||||||||
Costs
and expenses
|
|||||||||||||
Research
and development
|
|||||||||||||
Share-based
compensation
|
$
|
539,000
|
$
|
529,000
|
$
|
10,000
|
1.89
|
%
|
|||||
In-license,
milestone and related fees
|
2,245,000
|
250,000
|
1,995,000
|
798.00
|
%
|
||||||||
Other
research and development expenses
|
5,752,000
|
5,394,000
|
358,000
|
6.64
|
%
|
||||||||
Total
research and development expenses
|
8,536,000
|
6,173,000
|
2,363,000
|
38.28
|
%
|
||||||||
General
and administrative
|
|||||||||||||
Share-based
compensation
|
902,000
|
1,147,000
|
(245,000
|
)
|
-21.36
|
%
|
|||||||
Other
general and administrative expenses
|
2,706,000
|
2,680,000
|
26,000
|
0.97
|
%
|
||||||||
Total
general and administrative expenses
|
3,608,000
|
3,827,000
|
(219,000
|
)
|
-5.72
|
%
|
|||||||
Other
income
|
112,000
|
305,000
|
(193,000
|
)
|
-63.28
|
%
|
|||||||
Net
loss
|
$
|
12,032,000
|
$
|
9,695,000
|
$
|
2,337,000
|
24.11
|
%
|
Years
Ending December 31,
|
Commitment
|
|
2008
|
$100,000
|
|
2009
and subsequent
|
$0
|
Exhibit
No.
|
Description
|
|
2.1
|
Agreement
and Plan of Merger among the Company, Manhattan Pharmaceuticals
Acquisition Corp. and Manhattan Research Development, Inc. (formerly
Manhattan Pharmaceuticals, Inc.) dated December 17, 2002 (incorporated
by
reference to Exhibit 2.1 from Form 8-K filed March 5,
2003).
|
|
2.2
|
Agreement
and Plan of Merger among the Registrant, Tarpan Therapeutics, Inc.
and
Tarpan Acquisition Corp., dated April 1, 2005 (incorporated by reference
to Exhibit 2.1 of the Registrant’s Form 8-K/A filed June 15,
2005).
|
|
3.1
|
Certificate
of incorporation, as amended through September 25, 2003 (incorporated
by
reference to Exhibit 3.1 to the Registrant’s Form 10-QSB for the quarter
ended September 30, 2003).
|
|
3.2
|
Bylaws,
as amended to date (incorporated by reference from Registrant’s
registration statement on Form SB-2, as amended (File
No.33-98478)).
|
|
4.1
|
Specimen
common stock certificate (incorporated by reference from Registrant’s
registration statement on Form SB-2, as amended (File
No.33-98478)).
|
|
4.2
|
Form
of warrant issued by Manhattan Research Development, Inc., which
automatically converted into warrants to purchase shares of the
Registrant’s common stock upon the merger transaction with such company
(incorporated by reference to Exhibit 4.1 to the Registrant’s Form 10-QSB
for the quarter ended March 31, 2003).
|
|
4.3
|
Form
of warrant issued to placement agents in connection with the Registrant’s
November 2003 private placement of Series A Convertible Preferred
Stock
and the Registrant’s January 2004 private placement (incorporated by
reference to Exhibit 4.18 to the Registrant’s Registration Statement on
Form SB-2 filed January 13, 2004 (File No.
333-111897)).
|
|
4.4
|
Form
of warrant issued to investors in the Registrant’s August 2005 private
placement (incorporated by reference to Exhibit 4.1 of the Registrant’s
Form 8-K filed September 1, 2005).
|
|
4.5
|
Form
of warrant issued to placement agents in the Registrant’s August 2005
private placement (incorporated by reference to Exhibit 4.2 of the
Registrant’s Form 8-K filed September 1, 2005).
|
|
10.1
|
1995
Stock Option Plan, as amended (incorporated by reference to Exhibit
10.18
to the Registrant’s Form 10-QSB for the quarter ended September 30,
1996).
|
|
10.2
|
Form
of Notice of Stock Option Grant issued to employees of the Registrant
from
April 12, 2000 to February 21, 2003 (incorporated by reference to
Exhibit
99.2 of the Registrant’s Registration Statement non Form S-8 filed March
24, 1998 (File 333-48531)).
|
10.3
|
Schedule
of Notices of Stock Option Grants, the form of which is attached
hereto as
Exhibit 4.2.
|
|
10.4
|
Form
of Stock Option Agreement issued to employees of the Registrant from
April
12, 2000 to February 21, 2003 (incorporated by reference to Exhibit
99.3
to the Registrant’s Registration Statement on Form S-8 filed March 24,
1998 (File 333-48531)).
|
|
10.5
|
License
Agreement dated on or about February 28, 2002 between Manhattan Research
Development, Inc. (f/k/a Manhattan Pharmaceuticals, Inc.) and
Oleoyl-Estrone Developments SL (incorporated by reference to Exhibit
10.6
to the Registrant’s Amendment No. 2 to Form 10-QSB/A for the quarter ended
March 31, 2003 filed on March 12, 2004).
|
|
10.6
|
License
Agreement dated April 4, 2003 between the Registrant and NovaDel
Pharma,
Inc. (incorporated by reference to Exhibit 10.1 to the Registrant’s
Amendment No. 1 to Form 10-QSB/A for the quarter ended June 30, 2003
filed
on March 12, 2004).++
|
|
10.7
|
2003
Stock Option Plan (incorporated by reference to Exhibit 4.1 to
Registrant’s Registration Statement on Form S-8 filed February 17,
2004).
|
|
10.8
|
Employment
Agreement dated April 1, 2005, between the Registrant and Douglas
Abel
(incorporated by reference to Exhibit 10.1 to the Registrant’s Form 8-K/A
filed June 15, 2005).
|
|
10.9
|
Sublicense
Agreement dated April 14, 2004 between Tarpan Therapeutics, Inc.,
the
Registrant’s wholly-owned subsidiary, and IGI, Inc. (incorporated by
reference to Exhibit 10.109 to IGI Inc.’s Form 10-Q for the quarter ended
March 31, 2004 (File No. 001-08568).
|
|
10.10
|
Form
of subscription agreement between the Registrant and the investors
in the
Registrant’s August 2005 private placement (incorporated by reference as
Exhibit 10.1 to the Registrant’s Form 8-K filed September 1,
2005).
|
|
10.11
|
Separation
Agreement between the Registrant and Alan G. Harris December 21,
2007
|
|
10.12
|
Employment
Agreement dated July 7, 2006 between the Registrant and Michael G.
McGuinness (incorporated by reference to Exhibit 10.1 of the Registrant’s
Form 8-K filed July 12, 2006).
|
|
10.13
|
Summary
terms of compensation plan for Registrant’s non-employee directors
(incorporated by reference to Exhibit 10.1 of Registrant’s Form 8-K filed
February 5, 2007).
|
|
10.14
|
Form
of Stock Option Agreement issued under the Registrant’s 2003 Stock Option
Plan.
|
|
10.15
|
Exclusive
License Agreement for “Altoderm” between Thornton & Ross Ltd. and
Manhattan Pharmaceuticals, Inc. dates April 3, 2007. Incorporated
by
reference to Exhibit 10.3 of the registrant’s form 10-Q for the quarter
ended June 30, 2007 filed on August 14,
2007.
|
10.16
|
Exclusive
License Agreement for “Altolyn” between Thornton &Ross Ltd. and
Manhattan Pharmaceuticals, Inc. dated April 3, 2007. Incorporated
by
reference to Exhibit 10.4 of the registrant’s form 10-Q for the quarter
ended June 30, 2007 filed on August 14, 2007.
|
|
10.17
|
Exclusive
License Agreement for “Hedrin” between Thornton &Ross Ltd. , Kerris,
S.A. and Manhattan Pharmaceuticals, Inc. dated June 26, 2007. Incorporated
by reference to Exhibit 10.5 of the registrant’s form 10-Q for the quarter
ended June 30, 2007 filed on August 14, 2007.
|
|
10.18
|
Supply
Agreement for “Hedrin” between Thornton & Ross Ltd. and Manhattan
Pharmaceuticals, Inc. dated June 26, 2007. Incorporated by reference
to
Exhibit 10.6 of the registrant’s form 10-Q for the quarter ended June 30,
2007 filed on August 14, 2007.
|
|
10.19
|
Joint
Venture Agreement between Nordic Biotech fund II K/S and Manhattan
Pharmaceuticals, Inc. to develop and commercialize “Hedrin” dated January
31, 2008.
|
|
10.20
|
Amendment
No. 1, dated February 25, 2008, to the Joint Venture Agreement between
Nordic Biotech fund II K/S and Manhattan Phaarmaceuticals, Inc. to
develop
and commercialize “Hedrin” dated January 31, 2008.
|
|
10.21
|
Assignment
and Contribution Agreement between Hedrin Pharmaceuticals K/S and
Manhattan Pharmaceuticals, Inc. dated February 25,
2008.
|
|
10.22
|
Registration
Rights Agreement between Nordic Biotech Venture Fund II K/S and Manhattan
Pharmaceuticals, Inc. dated February 25, 2008.
|
|
10.23
|
Amendment
to Employment Agreement by and between Manhattan Pharmaceuticals,
Inc. and
Douglas Abel
|
|
23.1
|
Consent
of J.H. Cohn LLP.
|
|
31.1
|
Certification
of Principal Executive Officer.
|
|
31.2
|
Certification
of Principal Financial Officer.
|
|
32.1
|
Certifications
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
++
|
Confidential
treatment has been granted as to certain portions of this exhibit
pursuant
to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
|
J.H.
Cohn LLP
|
|||||||
Fee
Category
|
Fiscal
2007 Fees
|
Fiscal
2006 Fees
|
|||||
Audit
Fees
|
$
|
103,940
|
$
|
100,111
|
|||
Audit-Related
Fees (1)
|
11,520
|
22,943
|
|||||
Tax
Fees (2)
|
18,708
|
21,165
|
|||||
All
Other Fees (3)
|
-
|
-
|
|||||
Total
Fees
|
$
|
134,168
|
$
|
144,219
|
Manhattan
Pharmaceuticals, Inc.
|
|
By:
|
/s/
Douglas Abel
|
Douglas
Abel
|
|
Chief
Executive Officer and President
|
Signature
|
Title
|
Date
|
||
/s/
Douglas Abel
|
Chief
Executive Officer, President and
|
March
31, 2008
|
||
Douglas
Abel
|
Director (principal executive officer) | |||
/s/
Michael G. McGuinness
|
Secretary
and Chief Financial Officer
|
March
31, 2008
|
||
Michael
G. McGuinness
|
(principal accounting and financial officer) | |||
/s/
Neil Herskowitz
|
Director
|
March
31, 2008
|
||
Neil
Herskowitz
|
||||
/s/
Malcolm Hoenlein
|
Director
|
March
31, 2008
|
||
Malcolm
Hoenlein
|
||||
/s/
Timothy McInerney
|
Director
|
March
31, 2008
|
||
Timothy
McInerney
|
||||
/s/
Richard Steinhart
|
Director
|
March
31, 2008
|
||
Richard
Steinhart
|
||||
/s/
Michael Weiser
|
Director
|
March
31, 2008
|
||
Michael
Weiser
|
Page
|
|
Report
of Independent Registered Public Accounting Firm
|
F-2
|
Consolidated
Balance Sheets as of December 31, 2007 and 2006
|
F-3
|
Consolidated
Statements of Operations for the Years Ended December 31, 2007 and
2006
and the cumulative period from August 6, 2001 (inception) to December
31,
2007
|
F-4
|
Consolidated
Statement of Stockholders’ Equity (Deficiency) for the Years Ended
December
31, 2007 and 2006 and the cumulative period from August 6, 2001
(inception) to December 31, 2007
|
F-5
|
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2007 and
2006
and the cumulative period from August 6, 2001 (inception) to December
31,
2007
|
F-7
|
Notes
to Consolidated Financial Statements
|
F-8
|
December
31, 2007
|
December
31, 2006
|
||||||
Assets
|
|
||||||
Current
assets:
|
|
||||||
Cash
and cash equivalents
|
$
|
649,686
|
$
|
3,029,118
|
|||
Prepaid
expenses
|
215,852
|
264,586
|
|||||
|
|||||||
Total
current assets
|
865,538
|
3,293,704
|
|||||
|
|||||||
Property
and equipment, net
|
44,533
|
83,743
|
|||||
Other
assets
|
70,506
|
70,506
|
|||||
|
|||||||
Total
assets
|
$
|
980,577
|
$
|
3,447,953
|
|||
|
|||||||
Liabilities
and Stockholders’ Equity (Deficiency)
|
|
||||||
|
|||||||
Current
liabilities:
|
|
||||||
Accounts
payable
|
$
|
1,279,485
|
$
|
1,393,296
|
|||
Accrued
expenses
|
592,177
|
550,029
|
|||||
|
|||||||
Total
liabilities
|
1,871,662
|
1,943,325
|
|||||
|
|||||||
Commitments
and contingencies
|
|
||||||
|
|||||||
Stockholders’
equity (deficiency):
|
|
||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares issued
and
outstanding at December 31, 2007 and 2006
|
|||||||
Common
stock, $.001 par value. Authorized 150,000,000 shares; 70,624,232
and
60,120,038 shares issued and outstanding at December 31, 2007 and
December 31, 2006, respectively
|
70,624
|
60,120
|
|||||
Additional
paid-in capital
|
54,037,361
|
44,411,326
|
|||||
Deficit
accumulated during the development stage
|
(54,999,070
|
)
|
(42,966,818
|
)
|
|||
|
|||||||
Total
stockholders’ equity (deficiency)
|
(891,085
|
)
|
1,504,628
|
||||
|
|||||||
Total
liabilities and stockholders' equity (deficiency)
|
$
|
980,577
|
$
|
3,447,953
|
Years ended December 31,
|
Cumulative
period from
August 6, 2001
(inception) to
December 31,
|
|||||||||
2007
|
2006
|
2007
|
||||||||
Revenue
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
Costs
and expenses:
|
||||||||||
Research
and development
|
8,535,687
|
6,172,845
|
26,489,043
|
|||||||
General
and administrative
|
3,608,270
|
3,827,482
|
13,852,363
|
|||||||
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
|
12,143,957
|
10,000,327
|
54,691,321
|
|||||||
Operating
loss
|
(12,143,957
|
)
|
(10,000,327
|
)
|
(54,691,321
|
)
|
||||
Other
(income) expense:
|
||||||||||
Interest
and other income
|
(112,181
|
)
|
(307,871
|
)
|
(821,897
|
)
|
||||
Interest
expense
|
476
|
1,665
|
26,034
|
|||||||
Realized
(gain)/loss on sale of marketable equity securities
|
—
|
1,002
|
(76,032
|
)
|
||||||
Total
other income
|
(111,705
|
)
|
(305,204
|
)
|
(871,895
|
)
|
||||
Net
loss
|
(12,032,252
|
)
|
(9,695,123
|
)
|
(53,819,426
|
)
|
||||
Preferred
stock dividends (including imputed amounts)
|
—
|
—
|
(1,179,644
|
)
|
||||||
Net
loss applicable to common shares
|
$
|
(12,032,252
|
)
|
$
|
(9,695,123
|
)
|
$
|
(54,999,070
|
)
|
|
Net
loss per common share:
|
||||||||||
Basic
and diluted
|
$
|
(0.18
|
)
|
$
|
(0.16
|
)
|
||||
Weighted
average shares of common stock outstanding:
|
||||||||||
Basic
and diluted
|
68,015,075
|
60,112,333
|
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
|
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
|
)
|
Years ended December 31,
|
Cumulative
period from
August 6, 2001
(inception) to
December 31,
|
|||||||||
2007
|
2006
|
2007
|
||||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(12,032,252
|
)
|
$
|
(9,695,123
|
)
|
$
|
(53,819,426
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Share-based
compensation
|
1,440,956
|
1,675,499
|
3,364,983
|
|||||||
Shares
issued in connection with in-licensing agreement
|
232,500
|
—
|
232,500
|
|||||||
Warrants
issued to consultant
|
83,670
|
—
|
83,670
|
|||||||
Amortization
of intangible assets
|
—
|
—
|
145,162
|
|||||||
(Gain)/loss
on sale of marketable equity securities
|
—
|
1,002
|
(76,032
|
)
|
||||||
Depreciation
|
48,345
|
60,186
|
195,825
|
|||||||
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:
|
||||||||||
Decrease
(increase) in prepaid expenses and other current assets
|
48,734
|
(69,810
|
)
|
(157,607
|
)
|
|||||
Increase
in other assets
|
—
|
—
|
(70,506
|
)
|
||||||
Increase
(decrease) in accounts payable
|
(93,812
|
)
|
(224,193
|
)
|
1,699,698
|
|||||
Increase
in accrued expenses
|
42,148
|
501,701
|
51,856
|
|||||||
Net
cash used in operating activities
|
(10,229,711
|
)
|
(7,750,738
|
)
|
(34,160,556
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchase
of property and equipment
|
(9,134
|
)
|
(37,052
|
)
|
(230,635
|
)
|
||||
Cash
paid in connection with acquisitions
|
—
|
—
|
(26,031
|
)
|
||||||
Net
cash provided from the purchase and sale of short-term
investments
|
—
|
1,005,829
|
435,938
|
|||||||
Proceeds
from sale of license
|
—
|
—
|
200,001
|
|||||||
Net
cash (used in) provided by investing activities
|
(9,134
|
)
|
968,777
|
379,273
|
||||||
Cash
flows from financing activities:
|
||||||||||
Repayments
of notes payable to stockholders
|
—
|
—
|
(884,902
|
)
|
||||||
Proceeds
(costs) related to sale of common stock, net
|
7,852,185
|
(15,257
|
)
|
25,896,262
|
||||||
Proceeds
from sale of preferred stock, net
|
—
|
—
|
9,046,176
|
|||||||
Proceeds
from exercise of warrants and stock options
|
7,228
|
—
|
138,219
|
|||||||
Other,
net
|
—
|
—
|
235,214
|
|||||||
Net
cash provided by (used in) financing activities
|
7,859,413
|
(15,257
|
)
|
34,430,969
|
||||||
Net
(decrease) increase in cash and cash equivalents
|
(2,379,432
|
)
|
6,797,218
|
649,686
|
||||||
Cash
and cash equivalents at beginning of period
|
3,029,118
|
9,826,336
|
—
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
649,686
|
$
|
3,029,118
|
$
|
649,686
|
||||
Supplemental
disclosure of cash flow information:
|
||||||||||
Interest
paid
|
$
|
475
|
$
|
1,665
|
$
|
26,033
|
||||
Supplemental
disclosure of noncash investing and financing activities:
|
||||||||||
Common
stock issued in satisfaction of accounts payable
|
$
|
20,000
|
$
|
—
|
$
|
770,000
|
||||
Imputed
preferred stock dividend
|
—
|
—
|
418,182
|
|||||||
Preferred
stock dividends accrued
|
—
|
—
|
761,462
|
|||||||
Conversion
of preferred stock to common stock
|
—
|
—
|
1,067
|
|||||||
Preferred
stock dividends paid by issuance of shares
|
—
|
—
|
759,134
|
|||||||
Issuance
of common stock for acquisitions
|
—
|
—
|
13,389,226
|
|||||||
Issuance
of common stock in connection with in-licensing agreement
|
232,500
|
232,500
|
||||||||
Marketable
equity securities received in connection with sale of
license
|
—
|
—
|
359,907
|
|||||||
Warrants
issued to consultant
|
83,670
|
—
|
83,670
|
|||||||
Net
liabilities assumed over assets acquired in business
combination
|
—
|
—
|
(675,416
|
)
|
||||||
Cashless
exercise of warrants
|
6
|
27
|
33
|
2007
|
2006
|
||||||
General
and administrative expense:
|
|||||||
Share-based
employee compensation cost
|
$
|
891,897
|
$
|
1,176,618
|
|||
Share-based
consultant and non-employee cost
|
10,550
|
(29,842
|
)
|
||||
$
|
902,447
|
$
|
1,146,776
|
||||
Research
and development expense
|
|||||||
Share-based
employee compensation cost
|
$
|
555,663
|
$
|
494,043
|
|||
Share-based
consultant and non-employee cost
|
(17,154
|
)
|
34,680
|
||||
$
|
538,509
|
$
|
528,723
|
||||
Total
share-based cost
|
$
|
1,440,956
|
$
|
1,675,499
|
2007
|
2006
|
||||||
Expected
volatility
|
93%
|
|
84%
- 98%
|
|
|||
Dividend
yield
|
—
|
—
|
|||||
Expected
term (in years)
|
5
- 10
|
5
- 10
|
|||||
Risk-free
interest rate
|
3.6%
- 4.9%
|
|
4.45%
- 5.1%
|
|
|||
|
|||||||
Forfeiture
rate
|
7%
|
|
4%
|
|
2007
|
2006
|
||||||
Property
and equipment
|
$
|
226,010
|
$
|
244,040
|
|||
Less
accumulated depreciation
|
(181,477
|
)
|
(160,297
|
)
|
|||
Net
property and equipment
|
$
|
44,533
|
$
|
83,743
|
2007
|
|||||||||||||
Shares
|
Weighted
average
exercise
price
|
Weighted
Average
Remaining
Contractual
Term
(years)
|
Aggregate
Intrinsic
Value
|
||||||||||
Outstanding
at beginning of year
|
7,000,504
|
$
|
1.310
|
||||||||||
Granted
|
1,342,500
|
$
|
0.875
|
||||||||||
Exercised
|
-
|
||||||||||||
Cancelled
|
(309,166
|
)
|
$
|
0.336
|
|||||||||
8,033,838
|
$
|
1.253
|
6.887
|
$
|
|
||||||||
Options
exercisable at year-end
|
5,601,714
|
$
|
1.263
|
6.625
|
$
|
|
|||||||
Weighted-average
fair value of options granted during the year
|
$ |
0.63
|
Number
|
Remaining
|
Number
of
|
|||||||||
Exercise
|
of
Options
|
Contractual
|
Options
|
||||||||
Price
|
Outstanding
|
Life
(years)
|
Exercisable
|
||||||||
|
|
|
|
||||||||
$ |
0.40
|
876,090
|
5.16
|
876,090
|
|||||||
0.43
|
400
|
5.15
|
400
|
||||||||
0.70
|
220,000
|
8.53
|
73,333
|
||||||||
0.72
|
365,000
|
9.09
|
32,500
|
||||||||
0.82
|
75,000
|
9.08
|
-
|
||||||||
0.89
|
16,667
|
8.38
|
16,667
|
||||||||
0.95
|
670,000
|
9.32
|
100,000
|
||||||||
0.97
|
440,000
|
6.75
|
440,000
|
||||||||
1.00
|
65,000
|
4.24
|
65,000
|
||||||||
1.00
|
290,698
|
7.04
|
290,698
|
||||||||
1.25
|
12,000
|
4.08
|
12,000
|
||||||||
1.25
|
163,750
|
4.14
|
163,750
|
||||||||
1.35
|
108,333
|
8.08
|
64,999
|
||||||||
1.35
|
300,000
|
8.09
|
300,000
|
||||||||
1.35
|
60,000
|
8.53
|
20,000
|
||||||||
1.50
|
2,923,900
|
7.25
|
1,949,277
|
||||||||
1.50
|
250,000
|
2.58
|
25,000
|
||||||||
1.60
|
100,000
|
7.46
|
75,000
|
||||||||
1.65
|
1,077,000
|
6.08
|
1,077,000
|
||||||||
4.38
|
10,000
|
3.14
|
10,000
|
||||||||
20.94
|
10,000
|
2.28
|
10,000
|
||||||||
Total
|
8,033,838
|
5,601,714
|
Number
of
|
Remaining
|
Number
of
|
|||||||||
Exercise
price
|
Warrants
outstanding
|
contractual
life
(years)
|
warrants
exercisable
|
||||||||
$
|
0.28
|
150,000
|
4.64
|
150,000
|
|||||||
0.78
|
10,000
|
1.98
|
10,000
|
||||||||
1.00
|
3,564,897
|
4.25
|
3,564,897
|
||||||||
1.00
|
509,275
|
4.25
|
509,275
|
||||||||
1.10
|
909,090
|
.85
|
909,090
|
||||||||
1.10
|
326,499
|
1.04
|
326,499
|
||||||||
1.44
|
2,161,767
|
2.65
|
2,161,767
|
||||||||
1.44
|
540,449
|
2.65
|
540,449
|
||||||||
1.44
|
135,135
|
2.65
|
135,135
|
||||||||
1.49
|
221,741
|
2.67
|
221,741
|
||||||||
1.49
|
55,000
|
2.67
|
55,000
|
||||||||
1.90
|
10,000
|
1.21
|
10,000
|
||||||||
1.90
|
90,000
|
1.21
|
90,000
|
||||||||
6.69
|
185,601
|
.10
|
185,601
|
||||||||
Total
|
8,869,454
|
8,869,454
|
2007
|
2006
|
||||||
Deferred
tax assets:
|
|||||||
Tax
loss carryforwards
|
$
|
22,513,000
|
$
|
18,265,000
|
|||
Research
and development credit
|
1,769,000
|
1,374,000
|
|||||
In-process
research and development charge
|
4,850,000
|
4,850,000
|
|||||
Stock
based compensation
|
1,270,000
|
682,000
|
|||||
Other
|
85,000
|
29,000
|
|||||
Gross
deferred tax assets
|
30,487,000
|
25,200,000
|
|||||
Less
valuation allowance
|
(30,487,000
|
)
|
(25,200,000
|
)
|
|||
Net
deferred tax assets
|
$
|
—
|
$
|
—
|
2007
|
2006
|
||||||||||||
%
of
|
%
of
|
||||||||||||
pretax
|
pretax
|
||||||||||||
Amount
|
loss
|
Amount
|
loss
|
||||||||||
Federal
income tax benefit at statutory rate
|
$
|
(4,102,000
|
)
|
(34.0
|
)%
|
$
|
(3,296,000
|
)
|
(34.0
|
)%
|
|||
State
income taxes, net of federal tax
|
(820,000
|
)
|
(6.8
|
)%
|
(659,000
|
)
|
(6.8
|
)%
|
|||||
Research
and development credits
|
(366,000
|
)
|
(3.0
|
)%
|
(200,000
|
)
|
(1.7
|
)%
|
|||||
Other
|
1,000
|
0.0
|
%
|
(166,000
|
)
|
(2.1
|
)%
|
||||||
Change
in valuation
|
|||||||||||||
allowance
|
5,287,000
|
43.8
|
%
|
4,321,000
|
44.6
|
%
|
|||||||
|
— |
—
|
%
|
—
|
—
|
%
|
Years
Ending December 31,
|
Commitment
|
|||
2008
|
$
|
100,000
|
||
2009
and subsequent
|
$
|
0
|
Exhibit
No.
|
Description
|
|
10.11
|
Separation
Agreement between the Registrant and Alan G. Harris dated December
21,
2007.
|
|
10.19
|
Joint
Venture Agreement between Nordic Biotech fund II K/S and Manhattan
Pharmaceuticals, Inc. to develop and commercialize “Hedrin” dated January
31, 2008.
|
|
10.20
|
Amendment
No. 1, dated February 25, 2008, to the Joint Venture Agreement between
Nordic Biotech fund II K/S and Manhattan Pharmaceuticals, Inc. to
develop
and commercialize “Hedrin” dated January 31, 2008.
|
|
10.21
|
Assignment
and Contribution Agreement between Hedrin Pharmaceuticals K/S and
Manhattan Pharmaceuticals, Inc. dated February 25,
2008.
|
|
10.22
|
Registration
Rights Agreement between Nordic Biotech Venture Fund II K/S and Manhattan
Pharmaceuticals, Inc. dated February 25, 2008.
|
|
10.23
|
Amendment
to Employment Agreement by and between Manhattan Pharmaceuticals,
Inc. and
Douglas Abel
|
|
23.1
|
Consent
of J.H. Cohn LLP.
|
|
31.1
|
Certification
of Principal Executive Officer.
|
|
31.2
|
Certification
of Principal Financial Officer.
|
|
32.1
|
Certifications
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|