|
Page
|
|
|
Prospectus
Summary
|
1
|
Risk
Factors
|
7
|
Special
Note Regarding Forward-Looking Statements
|
17
|
Use
of Proceeds
|
17
|
Price
Range for our Common Stock
|
18
|
Dividend
Policy
|
18
|
Selected
Financial Information
|
19
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
20
|
Business
|
37
|
Management
|
54
|
Security
Ownership of Certain Beneficial Owners and Management
|
62
|
Certain
Relationships and Related Transactions
|
64
|
Description
of Securities to be Registered
|
67
|
Shares
Eligible for Future Sale
|
71
|
Selling
Securityholder
|
72
|
Plan
of Distribution
|
75
|
Legal
Matters
|
76
|
Experts
|
76
|
Disclosure
of Commission Position on Indemnification for Securities Act
Liabilities
|
76
|
Where
You Can Find Additional Information
|
76
|
Financial
Statements
|
F-1
|
Common
Stock Offered by Selling Securityholder (1):
|
|
33,928,571
shares
|
|
|
|
Common
Stock Issued and Outstanding as of September 15, 2008(2):
|
70,624,232
shares
|
|
|
||
Common
Stock Issued and Outstanding after this Offering (3):
|
104,552,803
shares
|
|
Use
of Proceeds:
|
|
We
will not receive cash proceeds from the exercise of all or any portion
of
the put right exercisable for shares of common stock being registered
in
this offering; however, in the event of any such exercise, we will
receive
all or a portion of the selling securityholder's equity interest
in Hedrin
Pharmaceuticals K/S, a Danish limited partnership of which we and
the
selling securityholder are partners. We also will receive the proceeds
of
any cash exercise of the warrant.
|
Over
the Counter Bulletin Board Symbol:
|
|
MHAN
|
Includes
(i)
26,785,714 shares of our common stock which are issuable upon exercise
of
the selling securityholder’s right to put all or a portion of the selling
securityholder’s equity interest in Hedrin Pharmaceuticals K/S and (ii)
7,142,857 shares of our common stock issuable upon exercise of an
outstanding warrant held by the selling securityholder.
|
(2)
|
Excludes
approximately 19,590,189 shares of our common stock issuable upon
exercise
of outstanding warrants and options to purchase shares of our common
stock
and up to 42,857,143 shares issuable, or which may become issuable,
upon
exercise of the selling securityholder's right to put, and our right
to
call, all
or a portion of the selling securityholder’s equity interest in Hedrin
Pharmaceuticals K/S and the warrant held by the selling securityholder.
|
(3)
|
Based
on the number of shares of our common stock outstanding as of September
15, 2008. Excludes approximately 19,590,189 shares issuable upon
exercise
of outstanding warrants and options to purchase shares of our common
stock.
|
Year Ended December 31,
|
Six Months Ended June 30,
|
Cumulative
period from
August 6, 2001
(inception) to
June 30,
|
||||||||||||||
2007
|
2006
|
2008
|
2007
|
2008
|
||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||
Revenue
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
||||||
Research
and development expense
|
$
|
8,535,687
|
$
|
6,172,845
|
$
|
1,365,799
|
$
|
5,551,082
|
$
|
27,854,842
|
||||||
General
and administrative expense
|
$
|
3,608,270
|
$
|
3,827,482
|
$
|
1,715,598
|
$
|
1,967,098
|
$
|
15,567,961
|
||||||
Stock-based
compensation
|
$
|
1,440,956
|
$
|
1,675,499
|
$
|
295,664
|
$
|
706,549
|
$
|
3,660,647
|
||||||
Net
loss attributable to common shares
|
$
|
(12,032,252
|
)
|
$
|
(9,695,123
|
)
|
$
|
(3,001,561
|
)
|
$
|
(7,458,657
|
)
|
$
|
(58,000,631
|
)
|
|
Net
loss per common share
|
$
|
(0.18
|
)
|
$
|
(0.16
|
)
|
$
|
(0.04
|
)
|
$
|
(0.11
|
)
|
N/A
|
|||
Statements
of Cash Flows Data:
|
||||||||||||||||
Net
cash used in operating activities
|
$
|
(10,229,711
|
)
|
$
|
(7,750,738
|
)
|
(2,903,970
|
)
|
(6,090,775
|
)
|
$
|
(37,064,526
|
)
|
|||
Net
cash provided by (used in) financing activities
|
$
|
7,859,413
|
$
|
(15,257
|
)
|
$
|
2,853,230
|
$
|
7,861,381
|
$
|
37,284,199
|
|||||
Cash
dividends declared
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
At
December 31,
2007
|
At
June 30, 2008
|
||||||
(unaudited)
|
|||||||
Balance
Sheets Data:
|
|||||||
Total
assets
|
$
|
980,577
|
$
|
973,340
|
|||
Total
liabilities
|
$
|
1,871,662
|
$
|
4,420,322
|
|||
Total
stockholders’ deficiency
|
$
|
(891,085
|
)
|
$
|
(3,446,982
|
)
|
· |
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
products;
|
· |
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
products 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.
|
· |
Manufacturers
of drug and medical devices 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.
|
·
|
that
a broker or dealer approve a person’s account for transactions in penny
stocks; and
|
·
|
the
broker or dealer receive from the investor a written agreement to
the
transaction, setting forth the identity and quantity of the penny
stock to
be purchased.
|
·
|
obtain
financial information and investment experience objectives of the
person;
and
|
·
|
make
a reasonable determination that the transactions in penny stocks
are
suitable for that person and the person has sufficient knowledge
and
experience in financial matters to be capable of evaluating the risks
of
transactions in penny stocks.
|
·
|
sets
forth the basis on which the broker or dealer made the suitability
determination; and
|
·
|
that
the broker or dealer received a signed, written agreement from the
investor prior to the transaction.
|
High
|
Low
|
||||||
2006
|
|||||||
First
Quarter
|
$
|
1.640
|
$
|
1.160
|
|||
Second
Quarter
|
$
|
1.360
|
$
|
0.075
|
|||
Third
Quarter
|
$
|
0.880
|
$
|
0.620
|
|||
Fourth
Quarter
|
$
|
0.920
|
$
|
0.620
|
|||
2007
|
|||||||
First
Quarter
|
$
|
0.960
|
$
|
0.700
|
|||
Second
Quarter
|
$
|
1.100
|
$
|
0.690
|
|||
Third
Quarter
|
$
|
0.780
|
$
|
0.220
|
|||
Fourth
Quarter
|
$
|
0.230
|
$
|
0.090
|
|||
2008
|
|||||||
First
Quarter
|
$
|
0.230
|
$
|
0.110
|
|||
Second
Quarter
|
$
|
0.180
|
$
|
0.100
|
|||
Third
Quarter (through August 28, 2008)
|
$
|
0.200
|
$
|
0.100
|
Year Ended December 31,
|
Six Months Ended June 30,
|
Cumulative
period from
August 6, 2001
(inception) to
December 31,
August 6, 2001
(inception) to
June 30,
|
||||||||||||||
2007
|
2006
|
2008
|
2007
|
2008
|
||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||
Revenue
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
||||||
Research
and development expense
|
$
|
8,535,687
|
$
|
6,172,845
|
$
|
1,365,799
|
$
|
5,551,082
|
$
|
27,854,842
|
||||||
General
and administrative expense
|
$
|
3,608,270
|
$
|
3,827,482
|
$
|
1,715,598
|
$
|
1,967,098
|
$
|
15,567,961
|
||||||
Stock-based
compensation
|
$
|
1,440,956
|
$
|
1,675,499
|
$
|
295,664
|
$
|
706,549
|
$
|
3,660,647
|
||||||
Net
loss attributable to common shares
|
$
|
(12,032,252
|
)
|
$
|
(9,695,123
|
)
|
$
|
(3,001,561
|
)
|
$
|
(7,458,657
|
)
|
$
|
(58,000,631
|
)
|
|
Net
loss per common share
|
$
|
(0.18
|
)
|
$
|
(0.16
|
)
|
$
|
(0.04
|
)
|
$
|
(0.11
|
)
|
N/A
|
|||
Statements
of Cash Flows Data:
|
||||||||||||||||
Net
cash used in operating activities
|
$
|
(10,229,711
|
)
|
$
|
(7,750,738
|
)
|
(2,903,970
|
)
|
(6,090,775
|
)
|
$
|
(37,064,526
|
)
|
|||
Net
cash provided by (used in) financing activities
|
$
|
7,859,413
|
$
|
(15,257
|
)
|
$
|
2,853,230
|
$
|
7,861,381
|
$
|
37,284,199
|
|||||
Cash
dividends declared
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
$
|
0
|
At
December 31,
2007
|
At
June 30, 2008
|
||||||
(unaudited)
|
|||||||
Balance
Sheets Data:
|
|||||||
Total
assets
|
$
|
980,577
|
$
|
973,340
|
|||
Total
liabilities
|
$
|
1,871,662
|
$
|
4,420,322
|
|||
Total
stockholders’ deficiency
|
$
|
(891,085
|
)
|
$
|
(3,446,982
|
)
|
|
·
|
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, through Hedrin
Pharmaceuticals K/S, a joint venture between the Company Nordic Biotech
Fund II K/S; and
|
·
|
Altolyn,
a proprietary site specific tablet formulation of oral cromolyn sodium
for
the treatment of mastocytosis.
|
Six Months ended June 30,
|
Increase
|
% Increase
|
|||||||||||
2008
|
2007
|
(decrease)
|
(decrease)
|
||||||||||
COSTS
AND EXPENSES
|
|||||||||||||
Research
and development
|
|||||||||||||
Share-based
compensation
|
$
|
80,000
|
$
|
224,000
|
$ |
(144,000
|
)
|
(64
|
)%
|
||||
Other
research and development expense
|
$
|
1,286,000
|
$
|
5,327,000
|
$ |
(4,041,000
|
)
|
(76
|
)%
|
||||
Total
research and development expense
|
$
|
1,366,000
|
$
|
5,551,000
|
$ |
(4,185,000
|
)
|
(75
|
)%
|
||||
General
and administrative
|
|||||||||||||
Share-based
compensation
|
$
|
215,000
|
$
|
482,000
|
$ |
(267,000
|
)
|
(55
|
)%
|
||||
Other
general and administrative expense
|
$
|
1,500,000
|
$
|
1,485,000
|
$
|
15,000
|
1
|
%
|
|||||
Total
general and administrative expense
|
$
|
1,715,000
|
$
|
1,967,000
|
$
|
(252,000
|
)
|
(13
|
)%
|
||||
Other
income
|
$
|
79,000
|
$
|
59,000
|
$
|
20,000
|
34
|
%
|
|||||
NET
LOSS
|
$ |
(3,002,000
|
)
|
$ |
(7,459,000
|
)
|
$
|
(4,457,000
|
)
|
(60
|
)%
|
Three Months ended June 30,
|
Increase
|
% Increase
|
|||||||||||
2008
|
2007
|
(decrease)
|
(decrease)
|
||||||||||
COSTS
AND EXPENSES
|
|||||||||||||
Research
and development
|
|||||||||||||
Share-based
compensation
|
$
|
27,000
|
$
|
122,000
|
$ |
(95,000
|
)
|
(77
|
)%
|
||||
Other
research and development expense
|
$
|
539,000
|
$
|
3,750,000
|
$ |
(3,211,000
|
)
|
(86
|
)%
|
||||
Total
research and development expense
|
$
|
566,000
|
$
|
3,872,000
|
$ |
(3,306,000
|
)
|
(85
|
)%
|
||||
General
and administrative
|
|||||||||||||
Share-based
compensation
|
$
|
75,000
|
$
|
250,000
|
$ |
(175,000
|
)
|
(70
|
)%
|
||||
Other
general and administrative expense
|
$
|
826,000
|
$
|
803,000
|
$
|
23,000
|
3
|
%
|
|||||
Total
general and administrative expense
|
$
|
901,000
|
$
|
1,053,000
|
$
|
(152,000
|
)
|
(14
|
)%
|
||||
Other
income
|
$
|
45,000
|
$
|
30,000
|
$
|
15,000
|
50
|
%
|
|||||
NET
LOSS
|
$ |
(1,442,000
|
)
|
$ |
(4,895,000
|
)
|
$ |
(3,473,000
|
)
|
(71
|
)%
|
|
Years ended December 31,
|
Increase
|
% Increase
|
||||||||||
|
2007
|
2006
|
(decrease)
|
(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
|
%
|
|
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.
|
Name
|
|
Age
|
|
Position(s)
Held
|
|
Director
Since
|
|
|||
Douglas
Abel
|
|
|
47
|
|
|
President,
Chief Executive Officer and Director
|
|
|
2005
|
|
Neil
Herskowitz
|
|
|
51
|
|
|
Director
|
|
|
2004
|
|
Malcolm
Hoenlein
|
|
|
64
|
|
|
Director
|
|
|
2004
|
|
Timothy
McInerney
|
|
|
47
|
|
|
Director
|
|
|
2004
|
|
Richard
I. Steinhart
|
|
|
51
|
|
|
Director
|
|
|
2004
|
|
Michael
Weiser, M.D.
|
|
|
45
|
|
|
Director
|
|
|
2003
|
|
Name
of Committee
|
|
Membership
|
Audit
|
|
Messrs.
Herskowitz, Hoenlein and Steinhart (Chair)
|
|
|
|
Compensation
|
|
Messrs.
Herskowitz, Hoenlein, Steinhart and Weiser (Chair)
|
|
|
|
Nominating
and Governance
|
|
Messrs.
Herskowitz, Hoenlein and Steinhart
(Chair)
|
Name
|
|
Age
|
|
Position
|
Douglas
Abel
|
|
47
|
|
President
& Chief Executive Officer and Director
|
Michael
G. McGuinness
|
|
54
|
|
Chief
Operating and Financial Officer &
Secretary
|
Name and
Principal
Position
|
Year
|
Salary
|
Bonus
|
Option
Awards
|
Non-Equity
Incentive Plan
Compensation
|
Nonqualified
Deferred
Compensation
Earnings
|
All Other
Compensation
|
Total
|
|||||||||||||||||
Douglas Abel
Chief
Executive
Officer
and
President
|
2007
2006
|
$
$
|
345,000
325,000
|
$
$
|
180,000
150,000
|
(3)
|
$
$
|
910,224
1,156,065
|
(5)
(5)
|
$
$
|
0
0
|
$
$
|
0
0
|
$
$
|
42,333
116,776
|
(4)
(4)
|
$
$
|
1,477,557
1,748,841
|
|||||||
Alan
G. Harris (1)
Chief
Medical
Officer
|
2007
2006
|
$
$
|
288,333
252,083
|
$
$
|
0
107,500
|
$
$
|
292,530
98,837
|
(5)
(5)
|
$
$
|
0
0
|
$
$
|
0
0
|
$
$
|
9,000
8,800
|
(6)
(6)
|
$
$
|
589,863
467,220
|
||||||||
Michael
McGuinness(2)
Chief
Operating
and
Financial
Officer,
Secretary
|
2007
2006
|
$
$
|
238,333
98,229
|
$
$
|
100,000
60,000
|
(3) |
$
$
|
95,528
23,622
|
(5)
(5)
|
$
$
|
0
0
|
$
$
|
0
0
|
$
$
|
9,000
0
|
(6)
|
$
$
|
442,861
181,851
|
(1)
|
Dr.
Harris was appointed our Chief Medical Officer on February 1, 2006.
Dr.
Harris’ employment with us ended effective December 31,
2007.
|
(2)
|
Mr.
McGuinness was appointed our Chief Financial Officer on July 10,
2006 and
Chief Operating Officer on April 1,
2008.
|
(3)
|
The
Company has accrued for such bonuses but has not paid such bonuses.
Payment of such bonuses are contingent upon our raising additional
financing and shall be paid as follows: (i) 50% will be paid when
we have
consummated a financing transaction with gross proceeds (net of
commissions) to the Company of at least $1,000,000 and (ii) the
remaining
50% will be paid when we have consummated a financing transaction
with
gross proceeds (net of commissions) to us of at least $2.5 million
(cumulative, including the $1 million financing transaction referred
to
above).
|
(4)
|
For
2007 represents a payment in the amount of $33,333, which represents
the
approximate amount of additional expense incurred by Mr. Abel relating
to
his commuting between Boston and New York and a tax “gross up” to cover
the additional tax liability to Mr. Abel from such payment, and
a matching
contributions by us pursuant to our company’s 401(k) retirement plan of
$9,000. For 2006 represents a payment in the amount of $83,333,
which
represents the approximate amount of additional expense incurred
by Mr.
Abel relating to his commuting between Boston and New York and
a tax
“gross up” to cover the additional tax liability to Mr. Abel from such
payment, reimbursement of certain commuting expenses of $24,643
and a
matching contributions by us pursuant to our company’s 401(k) retirement
plan of $8,800.
|
(5)
|
Represents
the amount of share-based costs recognized by us during 2007 under
SFAS
No. 123(R). See Note 3 to our Consolidated Financial Statements
included
in our annual report for 2007 on Form 10-K and for 2006 on Form
10-KSB for
the assumptions made in the valuation.
|
(6)
|
Represents
matching contributions by us pursuant to our company’s 401(k) retirement
plan.
|
Option
Awards
|
|||||||||||||
Name
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Option Exercise
Price ($)
|
Option
Expiration Date
|
|||||||||
Douglas
Abel
|
2,923,900
0
|
0
250,000
|
$
$
|
1.50
0.95
|
04/01/2015
04/25/2017
|
||||||||
Alan
Harris
|
300,000
100,000
|
0
0
|
$
$
|
1.35
0.95
|
12/31/2009
12/31/2009
|
||||||||
Michael
McGuinness
|
73,333
20,000
0
|
146,667
40,000
320,000
|
$
$
$
|
0.70
1.35
0.95
|
07/10/2016
07/10/2016
04/25/2017
|
Name
|
Fees Earned or
Paid in
Cash
|
Option
Awards (1)
|
All Other
Compensation
|
Total
|
|||||||||
Neil Herskowitz
|
$
|
27,500
|
$
|
7,948
|
(3)
|
$
|
0
|
$
|
35,448
|
||||
Malcolm
Hoenlein
|
$
|
25,000
|
$
|
7,948
|
(4)
|
$
|
0
|
$
|
32,948
|
||||
Timothy
McInerney
|
$
|
24,000
|
$
|
7,948
|
(5)
|
$
|
0
|
$
|
31,948
|
||||
Joan
Pons Gimbert (2)
|
$
|
12,000
|
$
|
7,948
|
(6)
|
$
|
0
|
$
|
19,948
|
||||
Richard
I. Steinhart
|
$
|
27,000
|
$
|
7,948
|
(7)
|
$
|
0
|
$
|
34,948
|
||||
Michael
Weiser
|
$
|
24,500
|
$
|
7,948
|
(8)
|
$
|
0
|
$
|
32,448
|
(1)
|
Represents
the amount of share-based costs recognized by us during 2006 under
SFAS
No. 123(R). See Note 3 to our Consolidated Financial Statements
included
in our annual report for 2006 on Form 10-KSB for the assumptions
made in
the valuation.
|
(2)
|
Joan
Pons Gimbert resigned from the Board in July
2007.
|
(3)
|
As
of September 15, 2008, Mr. Herskowitz had options to purchase an
aggregate
of 216,010 shares of our common
stock.
|
(4)
|
As
of September 15, 2008, Mr. Hoenlein had options to purchase an
aggregate
of 216,010 shares of our common
stock.
|
(5)
|
As
of September 15, 2008, Mr. McInerney had options to purchase an
aggregate
of 236,010 shares of our common
stock.
|
(6)
|
As
of September 15, 2008, Mr. Pons Gimbert had options to purchase
an
aggregate of 133,334 shares of our common
stock.
|
(7)
|
As
of September 15, 2008, Mr. Steinhart had options to purchase an
aggregate
of 216,010 shares of our common
stock.
|
(8)
|
As
of September 15, 2008, Mr. Weiser had options to purchase an aggregate
of
230,000 shares of our common stock.
|
of
our common stock;
|
Name of Beneficial Owners, Officers and Directors
|
Number of
Shares
Beneficially
Owned (#)
|
|
Percentage
Beneficially
Owned (%)
|
||||
Douglas
Abel (1)
|
3,519,566
|
4.8
|
|||||
Michael
McGuinness (2)
|
694,000
|
1.0
|
|||||
Michael
Weiser (3)
|
2,562,651
|
3.6
|
|||||
Timothy
McInerney (4)
|
990,857
|
1.4
|
|||||
Neil
Herskowitz (5)
|
347,128
|
*
|
|||||
Richard
I. Steinhart (6)
|
154,967
|
*
|
|||||
Malcolm
Hoenlien (7)
|
150,525
|
*
|
|||||
All
directors and officers as a group (8)(7
persons)
|
8,419,694
|
11.1
|
|||||
Lester
Lipschutz (9)
1650
Arch Street, Philadelphia, PA 19103
|
8,941,873
|
12.7
|
|||||
Lindsay
Rosenwald (10)
787
Seventh Avenue
New
York, NY 10019
|
4,224,268
|
5.9
|
|||||
Nordic
Biotech Venture Fund II K/S(11)
Ostergrade
5, 3rd floor, DK-1100
Copenhagen
K, Denmark
|
33,928,571
|
32.5
|
|
(1)
|
Includes
3,440,566 shares issuable upon exercise of vested portions of options
and
24,000 shares issuable upon exercise of warrants.
|
|
(2)
|
Includes
660,000 shares issuable upon exercise of vested portions of options
and
24,000 shares issuable upon exercise of warrants.
|
|
(3)
|
Includes
163,334 shares issuable upon the exercise of vested portions of
options,
and 151,754 shares issuable upon exercise of
warrants.
|
|
(4)
|
Includes
183,334 shares issuable upon exercise of vested portions of options;
and
139,863 shares issuable upon exercise of
warrants.
|
|
(5)
|
Includes
149,344 shares issuable upon exercise of vested portions of options,
and
43,444 shares issuance upon exercise of warrants; 77,288 shares
held by
Riverside Contracting, LLC, a limited liability company of which
Mr.
Herskowitz is a member holding 50% ownership and 44,168 shares
held by
ReGen Capital II, LLC, a limited liability company of which Mr.
Herskowitz
is a member holding 50% ownership.
|
|
(6)
|
Includes
149,344 shares issuable upon exercise of vested portions of
options.
|
|
(7)
|
Includes
149,344 shares issuable upon exercise of vested portions of
options.
|
|
(8)
|
Includes
4,895,246 shares issuable upon exercise of vested portions of options;
383,061 shares issuable upon the exercise of warrants; 77,288 shares
held
by Riverside Contracting, LLC, a limited liability company of which
Mr.
Herskowitz is a member holding 50% ownership and 44,168 shares
held by
ReGen Capital II, LLC, a limited liability company of which Mr.
Herskowitz
is a member holding 50% ownership.
|
|
(9)
|
Includes
8,941,873 shares of Common Stock held by separate trusts for the
benefit
of Dr. Rosenwald or his family with respect to which Mr. Lipschutz
is
either trustee or investment manager and in either case has investment
and
voting power. Mr. Lipschutz disclaims beneficial ownership of these
shares, except to the extent of his pecuniary interest therein,
if
any. The foregoing information is derived from a Schedule 13G filed
on behalf of the reporting person on August 1, 2007
|
|
(10)
|
Includes
3,183,497 shares held directly by Dr. Rosenwald, 1,040,658 shares
issuable
upon the exercise of warrants, 80 shares held by the Dr. Rosenwald's
wife,
over which Dr. Rosenwald may be deemed to have sole voting and
dispositive
power, although he disclaims beneficial ownership of such shares
except
with regard to his pecuniary interest therein, if any, and 33 shares
held
by Dr. Rosenwald’s children, over which Dr. Rosenwald may be deemed to
have sole voting and dispositive power, although he disclaims beneficial
ownership of such shares except with regard to his pecuniary interest
therein, if any. The foregoing information is derived from a Schedule
13G/A filed on behalf of the reporting person on February 13,
2008.
|
(11)
|
Includes
(i) 26,785,714 shares issuable upon exercise of Nordic's right
to put all
or a portion of Nordic Biotech Venture Fund II K/S' equity interest
in
Hedrin Pharmaceuticals K/S, a Danish limited partnership, of which
we and
Nordic are partners and (ii) 7,142,857 shares issuable upon exercise
of an
outstanding warrant held by Nordic. Does not include (i) 26,785,714
shares
issuable upon exercise of our right to call all or a portion of
Nordic’s
equity interest in Hedrin Pharmaceuticals K/S to the extent such
shares
are not issued upon exercise of Nordic’s put right, which call right is
subject to the satisfaction of certain conditions with respect
to the
closing price of our common stock and Nordic's right to refuse
such call
upon payment of cash or forfeiture of equity interests in Hedrin
Pharmaceuticals K/S, or (ii) 8,928,572 additional shares which
may become
issuable upon exercise of Nordic's right to put, or subject to
the
satisfaction of certain conditions and to certain exceptions discussed
above, our right to call, all or a portion of selling securityholder's
equity interest in Hedrin Pharmaceuticals K/S upon classification
of
Hedrin by the FDA, as a Class II or Class III medical device and
selling
securityholder's investment of an additional $1.25 million in Hedrin
Pharmaceuticals K/S. Florian Schonharting and Christian Hansen
have voting
and investment control over such
securities.
|
|
·
|
any
breach of his or her duty of loyalty to us or our
stockholders;
|
|
·
|
acts
or omissions not in good faith which involve intentional misconduct
or a
knowing violation of law;
|
|
·
|
the
payment of dividends or the redemption or purchase of stock in
violation
of Delaware law; or
|
|
·
|
any
transaction from which the director derived an improper personal
benefit.
|
• |
1.0%
of the number of ordinary shares then outstanding, which will equal
706,242 shares immediately after this offering;
or
|
• |
the
average weekly trading volume of the ordinary shares during the
four
calendar weeks preceding the filing of a notice on Form 144 with
respect
to the sale.
|
Number of
Shares
|
Common Stock Beneficially
Owned After this Offering
|
||||||||||||
Selling Securityholder
|
of Common
Stock
Beneficially
Owned Prior
to the Offering
|
Shares
Being
Offered
|
Number of
Shares
Outstanding
|
Percent
of Shares
Outstanding
|
|||||||||
Nordic
Biotech Venture Fund II K/S
|
33,928,571
|
(1)
|
33,928,571
|
(1)
|
0
|
0
|
·
|
ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
|
|
·
|
block
trades in which the broker-dealer will attempt to sell the shares
as agent
but may position and resell a portion of the block as principal
to
facilitate the transaction;
|
|
·
|
purchases
by a broker-dealer as principal and resale by the broker-dealer
for its
account;
|
|
·
|
an
exchange distribution in accordance with the rules of the applicable
exchange;
|
|
·
|
privately
negotiated transactions;
|
|
·
|
settlement
of short sales entered into after the effective date of the registration
statement of which this prospectus is a part;
|
|
·
|
broker-dealers
may agree with the selling securityholder to sell a specified number
of
such shares at a stipulated price per share;
|
|
·
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise;
|
|
·
|
a
combination of any such methods of sale; or
|
|
·
|
any
other method permitted pursuant to applicable
law.
|
Page
|
|
Unaudited
Condensed Consolidated Financial Statements as of June 30, 2008
and
2007
|
|
Unaudited
Condensed Consolidated Balance Sheets as of June 30, 2008 and December
31,
2007
|
F-2
|
Unaudited
Condensed Consolidated Statements of Operations For the Three and
Six
Months Ended June 30, 2008 and 2007 and the cumulative period from
August
6, 2001 (inception) to June 30, 2008
|
F-3
|
Unaudited
Condensed Consolidated Statement of Stockholders’ Equity (Deficiency) from
August 6, 2001 (inception) to June 30, 2008
|
F-4
|
Unaudited
Condensed Consolidated Statements of Cash Flows For the Six Months
Ended
June 30, 2008 and 2007 and the cumulative period from August 6,
2001
(inception) to June 30, 2008
|
F-6
|
Notes
to Unaudited Condensed Consolidated Financial Statements
|
F-7
|
Financial
Statements as of December 31, 2007 and 2006
|
|
Report
of Independent Registered Public Accounting Firm
|
F-20
|
Consolidated
Balance Sheets as of December 31, 2007 and 2006
|
F-21
|
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-22
|
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-23
|
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-25
|
Notes
to Consolidated Financial Statements
|
F-26
|
|
June 30,
2008
|
|
December 31,
2007
|
|
|||
|
|
(Unaudited)
|
|
(See Note 1)
|
|||
Assets
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
576,354
|
$
|
649,686
|
|||
Prepaid
expenses and other current assets
|
135,540
|
215,852
|
|||||
Total
current assets
|
711,894
|
865,538
|
|||||
|
|||||||
Investment
in Hedrin JV
|
142,408
|
-
|
|||||
Property
and equipment, net
|
34,912
|
44,533
|
|||||
Other
assets
|
84,126
|
70,506
|
|||||
Total
assets
|
$
|
973,340
|
$
|
980,577
|
|||
|
|||||||
Liabilities
and Stockholders’ Deficiency
|
|||||||
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
617,346
|
$
|
1,279,485
|
|||
Accrued
expenses
|
849,746
|
592,177
|
|||||
Total
current liabilities
|
1,467,092
|
1,871,662
|
|||||
Exchange
obligation
|
2,953,230
|
-
|
|||||
Total
liabilities
|
4,420,322
|
1,871,662
|
|||||
Commitments
and contingencies
|
|||||||
|
|||||||
Stockholders’
deficiency:
|
|||||||
Preferred
stock, $.001 par value. Authorized 1,500,000 shares; no shares
issued and
outstanding at June 30, 2008 and December 31, 2007
|
|||||||
Common
stock, $.001 par value. Authorized 300,000,000 shares; 70,624,232
shares
issued and outstanding at June 30, 2008 and December 31, 2007
|
70,624
|
70,624
|
|||||
Additional
paid-in capital
|
54,483,025
|
54,037,361
|
|||||
Deficit
accumulated during the development stage
|
(58,000,631
|
)
|
(54,999,070
|
)
|
|||
Total
stockholders’ deficiency
|
(3,446,982
|
)
|
(891,085
|
)
|
|||
|
|||||||
Total
liabilities and stockholders' deficiency
|
$
|
973,340
|
$
|
980,577
|
Three months ended June 30,
|
Six months ended June 30,
|
Cumulative
period from
August 6, 2001
(inception) to
June 30
|
||||||||||||||
2008
|
2007
|
2008
|
2007
|
2008
|
||||||||||||
Costs
and expenses:
|
||||||||||||||||
Research
and development
|
$
|
565,728
|
$
|
3,871,634
|
$
|
1,365,799
|
$
|
5,551,082
|
$
|
27,854,842
|
||||||
General
and administrative
|
901,538
|
1,052,374
|
1,715,598
|
1,967,098
|
15,567,961
|
|||||||||||
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
|
1,467,266
|
4,924,008
|
3,081,397
|
7,518,180
|
57,772,718
|
|||||||||||
Operating
loss
|
(1,467,266
|
)
|
(4,924,008
|
)
|
(3,081,397
|
)
|
(7,518,180
|
)
|
(57,772,718
|
)
|
||||||
Other
(income) expense:
|
||||||||||||||||
Equity
in loss of Hedrin JV
|
87,718
|
—
|
107,593
|
—
|
107,593
|
|||||||||||
Interest
and other income
|
(132,772
|
)
|
(29,608
|
)
|
(187,429
|
)
|
(59,998
|
)
|
(1,009,327
|
)
|
||||||
Interest
expense
|
—
|
—
|
—
|
475
|
26,034
|
|||||||||||
Realized
gain on sale of marketable equity securities
|
—
|
—
|
—
|
—
|
(76,032
|
)
|
||||||||||
Total
other income
|
(45,054
|
)
|
(29,608
|
)
|
(79,836
|
)
|
(59,523
|
)
|
(951,731
|
)
|
||||||
Net
loss
|
(1,422,212
|
)
|
(4,894,400
|
)
|
(3,001,561
|
)
|
(7,458,657
|
)
|
(56,820,987
|
)
|
||||||
Preferred
stock dividends (including imputed amounts)
|
—
|
—
|
—
|
—
|
(1,179,644
|
)
|
||||||||||
Net
loss applicable to common shares
|
$
|
(1,422,212
|
)
|
$
|
(4,894,400
|
)
|
$
|
(3,001,561
|
)
|
$
|
(7,458,657
|
)
|
$
|
(58,000,631
|
)
|
|
Net
loss per common share:
|
||||||||||||||||
Basic
and diluted
|
$
|
(0.02
|
)
|
$
|
(0.07
|
)
|
$
|
(0.04
|
)
|
$
|
(0.11
|
)
|
||||
Weighted
average shares of common stock outstanding:
|
||||||||||||||||
Basic
and diluted
|
70,624,232
|
70,463,543
|
70,624,232
|
65,377,865
|
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
|
)
|
|||||||||||||||||||||
Sale
of warrant
|
150,000
|
150,000
|
||||||||||||||||||||||||||||||||
Share-based
compensation
|
—
|
—
|
—
|
—
|
295,664
|
—
|
—
|
—
|
—
|
—
|
295,664
|
|||||||||||||||||||||||
Net
loss
|
—
|
—
|
—
|
—
|
-
|
—
|
(3,001,561
|
)
|
—
|
—
|
—
|
(3,001,561
|
)
|
|||||||||||||||||||||
Balance
at June 30, 2008
|
—
|
$
|
—
|
70,624,232
|
$
|
70,624
|
$
|
54,483,025
|
$
|
—
|
$
|
(58,000,631)
|
)
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
(3,446,982
|
)
|
|
|
Six
months ended June 30,
|
|
Cumulative
period
from
August
6, 2001
(inception)
to
|
|
|||||
|
|
2008
|
|
2007
|
|
June
30, 2008
|
||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(3,001,561
|
)
|
$
|
(7,458,657
|
)
|
$
|
(56,820,987
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Equity
in loss of Hedrin JV
|
107,593
|
—
|
107,593
|
|||||||
Share-based
compensation
|
295,664
|
706,549
|
3,660,647
|
|||||||
Shares
issued in connection with in-licensing agreement
|
—
|
112,500
|
232,500
|
|||||||
Warrants
issued to consultant
|
—
|
—
|
83,670
|
|||||||
Amortization
of intangible assets
|
—
|
—
|
145,162
|
|||||||
Gain
on sale of marketable equity securities
|
—
|
(76,032
|
)
|
|||||||
Depreciation
|
15,631
|
29,974
|
211,456
|
|||||||
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
|
2,962
|
—
|
8,552
|
|||||||
Changes
in operating assets and liabilities, net of acquisitions:
|
||||||||||
(Increase)/decrease
in prepaid expenses and other current assets
|
80,311
|
(88,071
|
)
|
(77,296
|
)
|
|||||
Increase
in other assets
|
—
|
-
|
(70,506
|
)
|
||||||
Increase
/(decrease) in accounts payable
|
(662,139
|
)
|
(371,447
|
)
|
1,037,559
|
|||||
Increase
in accrued expenses
|
257,569
|
978,377
|
309,425
|
|||||||
Net
cash used in operating activities
|
(2,903,970
|
)
|
(6,090,775
|
)
|
(37,064,526
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchase
of property and equipment
|
(8,972
|
)
|
(9,135
|
)
|
(239,607
|
)
|
||||
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
|
(22,592
|
)
|
(9,135
|
)
|
356,681
|
|||||
Cash
flows from financing activities:
|
||||||||||
Repayments
of notes payable to stockholders
|
—
|
—
|
(884,902
|
)
|
||||||
Proceeds
related to sale of common stock, net
|
—
|
7,854,153
|
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
|
|||||||
Proceeds
from the Hedrin JV Agreement, net
|
2,703,230
|
—
|
2,703,230
|
|||||||
Sale
of warrant
|
150,000
|
—
|
150,000
|
|||||||
Other,
net
|
—
|
—
|
235,214
|
|||||||
Net
cash provided by financing activities
|
2,853,230
|
7,861,381
|
37,284,199
|
|||||||
Net
(decrease) increase in cash and cash equivalents
|
(73,332
|
)
|
1,761,471
|
576,354
|
||||||
Cash
and cash equivalents at beginning of period
|
649,686
|
3,029,118
|
—
|
|||||||
Cash
and cash equivalents at end of period
|
$
|
576,354
|
$
|
4,790,589
|
$
|
576,354
|
||||
|
||||||||||
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
|
$
|
—
|
$
|
20,000
|
$
|
750,000
|
||||
Imputed
preferred stock dividend
|
—
|
—
|
418,182
|
|||||||
Preferred
stock dividends accrued
|
—
|
—
|
761,462
|
|||||||
Preferred
stock dividends paid by issuance of shares
|
—
|
—
|
9,046,176
|
|||||||
Conversion
of preferred stock to common stock
|
—
|
—
|
759,134
|
|||||||
Issuance
of common stock for acquisitions
|
—
|
—
|
13,389,226
|
|||||||
Issuance
of common stock in connection with in-licensing agreement
|
—
|
112,500
|
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
|
)
|
||||||
Investment
in Hedrin JV
|
250,000
|
—
|
250,000
|
|||||||
Cashless
exercise of warrants
|
—
|
6
|
33
|
Three months ended June 30,
|
Six months ended June 30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
General
and administrative expense:
|
|||||||||||||
Share-based
employee compensation cost
|
$
|
75,362
|
$
|
249,623
|
$
|
215,405
|
$
|
471,544
|
|||||
Share-based
consultant and non-employee (credit) cost
|
—
|
—
|
—
|
10,550
|
|||||||||
$
|
75,362
|
$
|
249,623
|
$
|
215,405
|
$
|
482,094
|
||||||
Research
and development expense:
|
|||||||||||||
Share-based
employee compensation cost
|
$
|
27,735
|
$
|
121,531
|
$
|
80,000
|
$
|
231,449
|
|||||
Share-based
consultant and non-employee (credit) cost
|
(287
|
)
|
185
|
259
|
(6,994
|
)
|
|||||||
$
|
27,448
|
$
|
121,716
|
$
|
80,259
|
$
|
224,455
|
||||||
Total
share-based cost
|
$
|
102,810
|
$
|
371,339
|
$
|
295,664
|
$
|
706,549
|
|
|
Three months ended June 30,
|
|
Six months ended June 30,
|
|
||||||||
|
|
2008
|
|
2007
|
|
2008
|
|
2007
|
|||||
Expected
Volatility
|
92.3
|
%
|
79.7
- 93.2
|
%
|
92.3
|
%
|
79.7
- 93.2
|
%
|
|||||
Dividend
yield
|
-
|
-
|
-
|
-
|
|||||||||
Expected
term (in years)
|
6
|
6
- 8
|
6
|
6
- 8
|
|||||||||
Risk-free
interest rate
|
2.81
|
%
|
4.56%
- 4.96
|
%
|
2.81
|
%
|
4.56%
- 4.96
|
%
|
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
|
(224,972
|
)
|
0.17
|
||||||||||
Outstanding
at June 30, 2008
|
10,766,336
|
$
|
0.93
|
7.46
|
$
|
-
|
|||||||
Exercisable
at June 30, 2008
|
8,004,692
|
$
|
1.12
|
6.80
|
|||||||||
Weighted
average fair value of options granted during the six months ended
June 30,
2008
|
$
|
0.13
|
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
|
(9) |
Income
Taxes
|
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
|
%
|
|||||||
|
— |
—
|
%
|
—
|
—
|
%
|
(10) |
License
and Consulting Agreements
|
(11) |
Commitments
and Contingencies
|
Years Ending December 31,
|
Commitment
|
|||
2008
|
$
|
100,000
|
||
2009
and subsequent
|
$
|
0
|
12. |
Subsequent
events
|