Filed
pursuant to Rule 424(b)(3)
|
|
File
No. 333-138782
|
|
Page
|
Prospectus
Summary
|
3
|
Risk
Factors
|
6
|
Note
Regarding Forward Looking Statements
|
13
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
13
|
Our
Company
|
20
|
Management
|
31
|
Security
Ownership of Certain Beneficial Owners and Management
|
38
|
Certain
Relationships and Related Transactions
|
39
|
Market
for Common Equity and Related Stockholder Matters
|
40
|
Use
of Proceeds
|
42
|
Selling
Stockholders
|
42
|
Plan
of Distribution
|
46
|
Description
of Capital Stock
|
48
|
Disclosure
Of Commission Position On Indemnification For Securities Act
Liabilities
|
48
|
About
This Prospectus
|
49
|
Where
You Can Find More Information
|
49
|
Validity
of Common Stock
|
49
|
Experts
|
49
|
Financial
Statements
|
F-1
|
·
|
VQD-001
- Sodium Stibogluconate (SSG).
VQD-001 is a pentavalent antimonial drug that has been used for over
50
years in parts of Africa and Asia for the treatment of leishmaniasis
(a
protozoan disease). The World Health Organization has stated that
leishmaniasis currently threatens 350 million men, women, and children
in
88 countries around the world. This drug is currently used to treat
military personnel serving in parts of the world where leishmaniasis
is
prevalent. Subsequently, and in collaboration with the U.S. Army,
we are
pursuing development of VQD-001 in the treatment of leishmaniasis
and
intend to file a new drug application, or NDA, with the U.S. Food
and Drug
Administration (FDA) in the first half of 2007. Already, VQD-001
has been
designated orphan drug status by the FDA in the first half of 2006
for the
treatment of leishmaniasis. Additionally, several preclinical studies,
especially those conducted at the Cleveland Clinic, showed that VQD-001
is
an inhibitor of multiple protein tyrosine phosphatases (PTPases),
specifically the SRC homology PTPase (SHP-1 & SHP-2). These
intracellular enzymes are involved in signaling pathways of many
receptor-linked tyrosine kinases which are involved in growth,
proliferation and differentiation of cancer cells. Inhibition of
these
enzymes with VQD-001 can trigger apoptosis of malignant cells. This
cytotoxic effect, coupled with its potential ability to enhance the
body’s
immune system, through improved cytokine signaling and t-cell formation,
suggest that VQD-001 has potential as an anti-cancer agent. On August
14,
2006, we received an acceptance letter for our Investigational New
Drug
Application (IND) for VQD-001. The FDA completed their review of
our IND
submission and have concluded that the clinical investigations described
in the protocol may begin. VQD-001 is currently being evaluated in
combination with IFN a-2b
in a 24-patient investigator-sponsored Phase I clinical trial at
the
Cleveland Clinic Taussig Cancer Center in refractory solid tumors,
lymphoma and myeloma. We are also currently evaluating the safety,
tolerability and activity of VQD-001 in a separate, company-sponsored
study of up to a 54-patient Phase I/IIa clinical trial at MD Anderson
Cancer Center in patients with advanced malignancies and solid tumors
that
have been non-responsive in previous cytokine
therapy.
|
· |
VQD-002
- Triciribine-Phosphate (TCN-P). Clinical
studies of VQD-002, a nucleoside analog, by the National Cancer Institute
in the 1980s and early 1990s showed compelling anti-cancer activities.
More recently, investigators at the Moffitt Cancer Center of the
University of South Florida were able to demonstrate from preclinical
studies that VQD-002’s mechanism of action is the inhibition of Akt
phosphorylation (protein kinase - B), which is found to be over activated
and over-expressed in various malignancies including breast, ovarian,
colorectal, and pancreatic and leukemias. Clinically, the over expression
of phosphorylated Akt is associated with poor prognosis, resistance
to
chemotherapy and shortened survival time of cancer patients. On April
11,
2006, we received an acceptance letter for our Investigational New
Drug
Application (IND) for VQD-002 from the FDA. The FDA completed their
review
of our IND submission and concluded that the clinical investigations
described in the protocol may begin. We are currently evaluating
the
safety, tolerability and activity of VQD-002 and its ability to reduce
Akt
phosphorylaion in two Phase I/IIa clinical trials, including one
at the
Moffitt Cancer Center in up to 42 patients with hyper-activated,
phosphorylated Akt in colorectal, pancreatic, breast and ovarian
tumors
and a second clinical trial, with up to 40 patients, at the MD Anderson
Cancer Center in hematologic tumors, with particular attention on
leukemia.
|
· |
7,891,600
shares of our outstanding common stock issued in connection with
an
October 2006 private placement;
|
· |
2,762,060
shares of our common stock issuable at a price of $0.73 per share
upon the
exercise of warrants issued to the investors in our October 2006
private
placement; and
|
· |
394,580
shares of our common stock issuable at a price of $0.55 per share
upon the
exercise of warrants issued to the placement agents in connection
with our
October 2006 private placement.
|
Common
stock offered
|
11,048,240
shares
|
|
|
Common
stock outstanding before the offering(1)
|
54,621,119 shares
|
|
Common
stock outstanding after the offering(2)
|
57,777,759
shares
|
|
Common
Stock OTC Bulletin Board symbol
|
VQPH.OB
|
(1)
|
Based
on the number of shares outstanding as of December 31, 2006, not
including
21,444,661 shares issuable upon exercise of various warrants and
options
to purchase common stock.
|
(2) |
Assumes
the issuance of all shares offered hereby that are issuable upon
exercise
of warrants.
|
· |
the
terms of our license agreements pursuant to which we obtain the
right to
develop and commercialize drug candidates, including the amount
of license
fees and milestone payments required under such agreements;
|
· |
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.
|
·
|
acquire
the rights to develop and commercialize a drug candidate;
|
|
·
|
continue
to undertake pre-clinical development and clinical trials for drug
candidates that we acquire;
|
|
·
|
seek
regulatory approvals for drug candidates;
|
|
·
|
implement
additional internal systems and infrastructure;
|
|
·
|
lease
additional or alternative office facilities; and
|
|
·
|
hire
additional personnel.
|
|
·
|
delay
commercialization of, and our ability to derive product revenues
from, a
drug candidate;
|
|
·
|
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 commercially reasonable
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 DEA, 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
pre-clinical testing and human clinical trials;
|
|
·
|
obtaining
FDA and other regulatory approvals of drugs;
|
|
·
|
formulating
and manufacturing drugs; and
|
|
·
|
launching,
marketing and selling drugs.
|
|
·
|
announcements
of technological innovations or new commercial products by our competitors
or us;
|
|
·
|
developments
concerning proprietary rights, including patents;
|
|
·
|
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.
|
|
· |
VQD-001
- Sodium Stibogluconate (SSG).
VQD-001 is a pentavalent antimonial drug that has been used for over
50
years in parts of Africa and Asia for the treatment of leishmaniasis
(a
protozoan disease) in some parts of the world for over 50 years.
As
published by the World Health Organization, leishmaniasis currently
threatens 350 million men, women, and children in 88 countries around
the
world. This drug is currently being used to treat military personnel
serving in parts of the world where this desease is prevalent.
Sebsequently and in collaboration with the U.S. Army, we are pursuing
development of VQD-001 in the treatment of leishmaniasis and intend
to
file a new drug application or NDA, with the U.S. Food and Drug
Administration (FDA) in the first half of 2007. Already, VQD-001
has been
designated orphan drug status by the FDA in the first half of 2006
for the
treatment of leishmaniasis. In other development, results from several
preclinical studies, especially those conducted at the Cleveland
Clinic
showed that VQD-001 is an inhibitor of multiple protein tyrosine
phosphatases (PTPases), specifically the SRC homology PTPase (SHP-1
&
SHP-2). These intracellular enzymes are involved in signaling pathways
of
many receptor-linked tyrosine kinases which are involved in growth,
proliferation and differentiation of cancer cells. Inhibition of
these
enzymes with VQD-001 can trigger apoptosis of malignant cells. This
cytotoxic effect, coupled with its potential ability to enhance the
body’s
immune system, through improved cytokine signaling and t-cell formation,
suggest that VQD-001 has potential as an anti-cancer agent. On August
14,
2006, we received an acceptance letter for our Investigational New
Drug
Application (IND) for VQD-001 from the FDA. The FDA completed their
review
of our IND submission and have concluded that the clinical investigation
(s) described in the protocol may begin. VQD-001 is currently being
evaluated in combination with IFN a-2b
in a 24-patient investigator-sponsored Phase I clinical trial at
the
Cleveland Clinic Taussig Cancer Center in refractory solid tumors,
lymphoma and myeloma. We are also currently evaluating the safety,
tolerability and activity of VQD-001 in a separate, company-sponsored
study of up to a 54-patient Phase I/IIa clinical trial at MD Anderson
Cancer Center in patients with advanced malignancies and solid tumors
that
have been non-responsive in previous cytokine therapy.
|
· |
VQD-002
- Triciribine-Phosphate (TCN-P). Clinical
studies of VQD-002, a nucleoside analog, by the National Cancer Institute
in the 1980s and early 1990s showed compelling anti-cancer activities.
More recently, investigators at the Moffitt Cancer Center of the
University of South Florida were able to demonstrate from preclinical
studies that VQD-002’s mechanism of action is the inhibition of Akt
phosphorylation (protein kinase - B) , which is found to be over
activated
and over-expressed in various malignancies, including, breast, ovarian,
colorectal, pancreatic and leukemias. Clinically, the over expression
of
phosphorylated Akt is associated with poor prognosis, resistance
to
chemotherapy and shortened survival time of cancer patients. On
April 11, 2006, we received an acceptance letter for our Investigational
New Drug Application (IND) for VQD-002 from the FDA. The FDA completed
their review of our IND submission and have concluded that the clinical
investigations (s) described in the protocol may begin. We
are currently evaluating the safety, tolerability and safety of VQD-002
and its impact of its ability to reduce Akt phosphorylation in two
Phase
I/IIa clinical trials, including one at the Moffitt Cancer Center
in up to
42 patients with hyper-activated, phosphorylated Akt in colorectal,
pancreatic, breast and ovarian tumors and a second clinical study
up to a
40-patient trial at the MD Anderson Cancer Center in hematologic
tumors,
particularly, leukemia.
|
· |
preclinical
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
|
|
Positions
|
Daniel
Greenleaf
|
|
42
|
|
President,
Chief Executive Officer and Director
|
Lawrence
Akinsanmi, M.D., Ph.D.
|
42
|
Vice
President of Clinical Operations and Regulatory Affairs
|
||
Michael
Cannarsa
|
|
50
|
|
General
Manager, Chiral Quest
|
Yaping
Hong
|
|
51
|
|
Senior
Vice President of Global Process Research and
Development
|
Brian
Lenz
|
|
34
|
|
Chief
Financial Officer, Treasurer and Secretary
|
Vincent
Aita, Ph.D.
|
|
33
|
|
Director
|
Johnson
Y. N. Lau, M.D.
|
|
45
|
|
Director
|
Stephen
C. Rocamboli
|
|
35
|
|
Interim
Chairman
|
Stephen
A. Roth, Ph.D.
|
|
64
|
|
Director
|
Michael
Weiser, M.D., Ph.D.
|
|
44
|
|
Director
|
Xumu
Zhang, Ph.D.
|
|
45
|
|
Chief
Technology Officer and Director
|
Annual
Compensation
|
Long-Term
Compensation
Awards
|
||||||||||||||||||
Name
& Position
|
Fiscal
Year
|
Salary
($)
|
|
Bonus
($)
|
Other
($)
|
Shares
Underlying
Options
(#)
|
All
Other Compensation ($)
|
||||||||||||
Daniel
Greenleaf (1)
|
2005
|
330,000
(1
|
)
|
305,000
(2
|
)
|
0
|
2,336,476
|
0
|
|||||||||||
President
& CEO
|
2004
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||
2003
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||
Ronald
Brandt (3)
|
2005
|
50,000
(3
|
)
|
—
|
105,000
(4
|
)
|
—
|
0
|
|||||||||||
Former
CEO, V.P.
|
2004
|
200,000
|
50,000
|
6,000
(5
|
)
|
125,000
|
0
|
||||||||||||
Business
Development
|
2003
|
165,000
|
0
|
4,800
(5
|
)
|
175,000
|
0
|
||||||||||||
Brian
Lenz
|
2005
|
130,000
|
35,000
|
0
|
160,000
|
0
|
|||||||||||||
Chief
Financial Officer
|
2004
|
94,000
|
17,000
|
0
|
25,000
|
0
|
|||||||||||||
2003
|
—
|
—
|
—
|
15,000
|
—
|
||||||||||||||
Michael
Cannarsa
|
2005
|
160,000
|
20,000
|
4,800
(5
|
)
|
175,000
|
0
|
||||||||||||
G.M.
Chiral Quest, Inc.
|
2004
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||
2003
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||
Yaping
Hong
|
2005
|
165,000
|
44,000
|
0
|
125,000
|
0
|
|||||||||||||
V.P.
of Process R&D
|
2004
|
165,000
|
20,000
|
0
|
50,000
|
0
|
|||||||||||||
2003
|
145,000
|
14,000
|
0
|
50,000
|
0
|
||||||||||||||
Richard
Welter (6)
|
2005
|
100,833
(6
|
)
|
47,000
(7
|
)
|
0
|
175,000
|
0
|
|||||||||||
V.P.
Corporate
|
2004
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||
Development
|
2003
|
—
|
—
|
—
|
—
|
—
|
(1)
|
Mr.
Greenleaf’s compensation represents amounts received from his hiring on
February 1, 2005, which included the prorated amount of his $360,000
annual base salary.
|
(2)
|
Includes
a signing bonus of $50,000, guaranteed bonus of $100,000 and bonuses
received upon reaching certain Company
milestones.
|
(3)
|
Mr.
Brandt served as the Company's Vice President of Business Development
from
October 2003 to April 2004. He was appointed interim President and
CEO in
April 2004 and held those positions until February 2005. Mr. Brandt’s
compensation represents amounts received up until April 4, 2005,
when he
resigned.
|
(4)
|
Represents
severance payment.
|
(5)
|
Represents
an automobile allowance.
|
(6)
|
Mr.
Welter’s compensation represents amounts received from his hiring on July
18, 2005, which included the prorated amount of his $220,000 annual
base
salary. Mr. Welter resigned his employment with us in June
2006.
|
(7) |
Includes
a $22,000 signing bonus.
|
Name
|
Shares
Underlying
Options
Granted
(#)
|
%
of Total
Options
Granted
to
Employees
in
Fiscal
Year(%)(1)
|
Exercise
Price
($/Share)
|
Expiration
Date
|
|||||||||
Daniel
Greenleaf
|
891,396
|
28.9
|
0.88
|
2/1/2015
|
|||||||||
1,445,080
|
46.9
|
0.89
|
10/19/2015
|
||||||||||
Ronald
Brandt
|
—
|
—
|
—
|
—
|
|||||||||
Brian
Lenz
|
60,000
|
1.9
|
1.08
|
1/24/2015
|
|||||||||
100,000
|
3.2
|
1.03
|
11/29/2015
|
||||||||||
Michael
Cannarsa
|
175,000
|
5.7
|
0.86
|
1/1/2015
|
|||||||||
Yaping
Hong
|
25,000
|
0.8
|
1.08
|
1/24/2015
|
|||||||||
100,000
|
3.2
|
1.03
|
11/29/2015
|
||||||||||
Richard
Welter
|
175,000
|
5.7
|
0.74
|
7/18/2015
|
|
Shares
|
|
Number
of Shares
Underlying
Unexercised
Options
at Fiscal Year End (#)
|
Value
of Unexercised
In-the-Money
Options
at
Fiscal Year End ($)(1)
|
|||||||||||||||
Name
|
Acquired
on
Exercise
|
Value
Realized
($)
|
Exercisable
|
Unexercisable
|
Exercisable
|
Unexercisable
|
|||||||||||||
Daniel
Greenleaf
|
0
|
-
|
0
|
2,336,476
|
0
|
0
|
|||||||||||||
Ronald
Brandt
|
0
|
-
|
0
|
0
|
0
|
0
|
|||||||||||||
Brian
Lenz
|
0
|
-
|
18,334
|
181,666
|
0
|
0
|
|||||||||||||
Michael
Cannarsa
|
0
|
-
|
0
|
175,000
|
0
|
0
|
|||||||||||||
Yaping
Hong
|
0
|
-
|
37,667
|
187,333
|
0
|
0
|
|||||||||||||
Richard
Welter
|
0
|
-
|
0
|
175,000
|
0
|
1,750
|
Name
and Address
|
Number
of Shares
Beneficially
Owned (1)
|
Percentage
of
Class
|
|||||
Daniel
Greenleaf
|
838,825(2)
|
1.5
|
|||||
Michael
Cannarsa, Ph.D.
|
116,667(3)
|
*
|
|||||
Yaping
Hong, Ph.D.
|
108,001(4)
|
*
|
|||||
Brian
Lenz
|
90,001(5)
|
*
|
|||||
Vincent
M. Aita, Ph.D.
|
242,374(6)
|
*
|
|||||
Stephen
C. Rocamboli
|
983,934(7)
|
1.8
|
|||||
Stephen
A. Roth, Ph.D.
|
102,900(8)
|
*
|
|||||
Michael
Weiser, M.D., Ph.D.
|
1,904,968(9)
|
3.5
|
|||||
Xumu
Zhang, Ph.D.
|
3,105,801(10)
|
5.6
|
|||||
Johnson
Y.N. Lau, M.D., Ph.D.
|
206,666(11)
|
*
|
|||||
Lawrence
Akinsanmi, M.D., Ph.D.
|
0
|
--
|
|||||
All
Executive Officers and Directors as a group (11 persons)
|
7,770,138(12)
|
13.7
|
|||||
Lester
Lipschutz
1650
Arch Street - 22nd
Floor
Philadelphia,
PA 19103
|
10,541,367
(13)
|
18.7
|
|||||
Lindsay
A. Rosenwald
787
7th
Avenue, 48th
Floor
New
York, NY 10019
|
3,425,999
(14)
|
6.2
|
(1)
|
Assumes
in each case that the stockholder exercised all options available
to the
person that have vested or will vest within 60
days.
|
(2)
|
Includes
shares issuable upon exercise (at a price of $0.88 per share) of
an
option, 297,132 shares of which vested on February 1, 2006 and
shares
issuable upon exercise (at a price of $0.89 per share) of an option
481,693 shares of which vested on February 1, 2006.
|
(3)
|
Includes
shares issuable upon exercise (at a price of $0.86 per share) of
an
option, 58,334 shares of which vested on January 1, 2006 and an
additional
58,333 shares will vet on January 1,
2007.
|
(4)
|
Represents:
i) shares issuable upon exercise (at a price of $1.50 per share)
of an
option, 10,000 shares of which vested on April 21, 2004, 11,000
of which
vested on April 21, 2005 and 12,000 of which vested on April 21,
2006; ii)
shares issuable upon exercise (at a price of $1.40 per share) of
an
option, 16,667 of which vested on April 19, 2005 and 16,667 which
vested
on April 21, 2006; iii) shares issuable upon exercise (at a price
of $1.08
per share) of an option, 8,333 shares of which vested on January
24, 2006;
and iv) shares issuable upon exercise (at a price of $1.03 per
share) of
an option, 33,334 shares of which will vest on November 29,
2006.
|
(5)
|
Represents:
i) shares issuable upon exercise (at a price of $1.67 per share)
of an
option, 5,000 shares of which vested on each of October 6, 2004,
October
6, 2005 and October 6, 2006; ii) shares issuable upon exercise
(at a price
of $1.40 per share) of an option, 8,333 of which vested on April
19, 2005
and 8,334 shares of which vested on April 19, 2006; iii) shares
issuable
upon exercise (at a price of $1.08 per share) of an option, 20,000
shares
of which vested on January 24, 2006; and iv) shares issuable
upon exercise
(at a price of $1.03 per share) of an option, 33,334 shares of
which will
vest on November 29, 2006.
|
(6)
|
Includes
12,900 shares issuable upon exercise (at a price of $1.96 per
share) of an
option, 4,300 shares of which vested on each of October 28, 2004,
October
28, 2005 and October 28, 2006.
|
(7)
|
Includes
719,335 shares owned by, and 149,000 shares issuable upon the
exercise of
two warrants held by, Stephen C. Rocamboli as Trustee for The
Stephen C.
Rocamboli April 2005 Trust u/a/d April 7, 2005, of which 308,318
shares
were issued in connection with our October 2005 acquisition of
Greenwich
Therapeutics, Inc. and remain held in escrow pending the achievement,
if
ever, of certain clinical milestones related to our product candidates
VQD-001 and VQD-002; and 12,900 shares issuable upon exercise
(at a price
of $1.96 per share) of an option, 4,300 shares of which vested
on each of
October 28, 2004, October 28 2005 and October 28, 2006.
|
(8)
|
Represents
i) 50,000 shares issuable upon exercise (at a price of $1.70
per share) of
an option, 16,667 shares of which vested on each of February
14, 2004 and
February 14, 2005 and 16,666 of which vested on February 14,
2006; ii)
12,900 shares issuable upon exercise (at a price of $1.96 per
share) of an
option, 4,300 shares of which vested on each of October 28, 2004,
October
28, 2005 and October 28, 2006; and iii) 40,000 shares issuable
upon
exercise (at a price of $0.75 per share) of an option, which
will vest on
January 12, 2007.
|
(9)
|
Includes
i) 280,000 shares issuable upon the exercise of a warrant; and
ii) 12,900
shares issuable upon exercise (at a price of $1.96 per share)
of an
option, 4,300 shares of which vested on each of October 28, 2004,
October
28, 2005 and October 28, 2006. Of the issued and outstanding
shares held
by Dr. Weiser, 1,199,015
were
issued in connection with our October 2005 acquisition of Greenwich
Therapeutics, Inc. and remain held in escrow pending the achievement,
if
ever, of certain clinical milestones related to our product candidates
VQD-001 and VQD-002.
|
(10)
|
Includes
487,539 shares issuable upon exercise (at a price of $1.49 per
share) of
an option 162,513 shares of which vested on each of May 15, 2004,
May 15,
2005 and May 15, 2006.
|
(11)
|
Includes
i) 56,666 shares issuable upon exercise (at a price of $0.75
per share) of
an option, which will vest on January 12, 2007; and ii) 150,000
shares
issuable upon exercise (at a price of $0.92 per share) of an
option which
vested on April 4, 2006.
|
(12) |
Includes
1,495,094 total options and 429,000 total warrants that are exercisable
currently or within the next 60
days.
|
(13)
|
Based
on Schedule 13D filed with the SEC on October 27, 2005. Represents
shares
owned equally by several trusts established for the benefit of
Dr. Lindsay
A. Rosenwald or members of his immediate family, for which Mr.
Lipschutz
is the trustee/investment manager, and over which he has voting
control
and investment power. Of the issued and outstanding shares held
such
trusts, 3,496,415 were
issued in connection with our October 2005 acquisition of Greenwich
Therapeutics, Inc. and remain held in escrow pending the achievement,
if
ever, of certain clinical milestones related to our product candidates
VQD-001 and VQD-002. Includes 1,633,000 shares issuable upon
the exercise
of warrants held by such trusts.
|
(14) |
Based
on a Schedule 13G/A filed December 31, 2005. Includes (i) 989,169
shares
issuable upon the exercise of warrants and (ii) 392,830 shares
held by
Paramount BioCapital Investments, LLC of which Dr. Rosenwald
is the
managing member. Of the issued and outstanding shares held by
Dr.
Rosenwald, 578,096 were issued in connection with our October
2005
acquisition of Greenwich Therapeutics, Inc. and remain held in
escrow
pending the achievement, if ever, of certain clinical milestones
related
to our product candidates VQD-001 and
VQD-002.
|
Quarter
Ended
|
High
|
Low
|
|||||
March
31, 2004
|
$
|
2.48
|
$
|
1.50
|
|||
June
30, 2004
|
$
|
1.76
|
$
|
0.80
|
|||
September
30, 2004
|
$
|
1.25
|
$
|
0.77
|
|||
December
31, 2004
|
$
|
1.35
|
$
|
0.77
|
|||
March
31, 2005
|
$
|
0.99
|
$
|
0.60
|
|||
June
30, 2005
|
$
|
1.01
|
$
|
0.59
|
|||
September
30, 2005
|
$
|
1.15
|
$
|
1.05
|
|||
December
31, 2005
|
$
|
0.76
|
$
|
0.70
|
|||
March
31, 2006
|
$
|
1.00
|
$
|
0.65
|
|||
June
30, 2006
|
$
|
1.15
|
$
|
0.62
|
|||
September
30, 2006
|
$
|
0.90
|
$
|
0.50
|
|||
December 31, 2006 |
$
|
0.43 |
$
|
0.40 |
Plan
category
|
Number
of
securities
to be
issued
upon
exercise
of
outstanding
options,
warrants
and
rights
(a)
|
Weighted
average
exercise
price
of
outstanding
options,
warrants
and
rights
(b)
|
Number
of
securities
remaining
available
for
future
issuance (excluding
securities
reflected
in
column (a)
(c)
|
|||||||
Equity
compensation plans approved by stockholders
|
-
|
$
|
-
|
-
|
||||||
Equity
compensation plans not approved by stockholders - 2003
Plan
|
6,073,853
|
$
|
1.05
|
426,147
|
· |
that
is a “reported security” as that term is defined by SEC rule, including
securities listed on the Nasdaq Stock Market, the New York Stock
Exchange
or the American Stock Exchange,
|
· |
that
is issued by an investment company,
|
· |
that
is a put or call option issued by the Options Clearing House,
|
· |
that
has a price of $5.00 or more, or
|
· |
whose
issuer has (i) net tangible assets of more than $2 million if the
issuer
has been in business for at least 3 continuous years, and $5 million
if
the issuer has been in business less than 3 years, (ii) average revenue
of
at least $6 million for the last 3 years.
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of
Shares
Offered
by
Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
|
|||||||||
Bill
and Nanette Abbott
|
90,720
|
67,200
|
23,520
|
—
|
|||||||||
Neel
B. and Martha N. Ackerman
|
415,800
|
308,000
|
107,800
|
—
|
|||||||||
David
W. Aibel
|
48,600
|
36,000
|
12,600
|
—
|
|||||||||
Andrew
W. Albstein
|
135,000
|
100,000
|
35,000
|
—
|
|||||||||
Alpha
Capital Anstalt
|
675,000
|
500,000
|
175,000
|
—
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of
Shares
Offered
by
Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
|
|||||||||
Jorge
Altschuler
|
108,000
|
80,000
|
28,000
|
—
|
|||||||||
David
Benadum
|
136,080
|
100,800
|
35,280
|
—
|
|||||||||
Alan
Bresler & Hanna Bresler
|
40,500
|
30,000
|
10,500
|
—
|
|||||||||
David
Brill
|
27,000
|
20,000
|
7,000
|
—
|
|||||||||
James
Buck
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
R.
Jackson Burkhalter
|
90,720
|
67,200
|
23,520
|
—
|
|||||||||
Lawrence
Burstein
|
135,000
|
100,000
|
35,000
|
—
|
|||||||||
Frank
Calcutta
|
151,200
|
112,000
|
39,200
|
—
|
|||||||||
John
P. Casey
|
270,000
|
200,000
|
70,000
|
—
|
|||||||||
Joseph
M.Collins
|
135,000
|
100,000
|
35,000
|
—
|
|||||||||
Steven
Cravath
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Ennio
DePianto
|
75,600
|
56,000
|
19,600
|
—
|
|||||||||
Praiful
Desai
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
David
DeValk
|
272,160
|
201,600
|
70,560
|
—
|
|||||||||
Donner
Plumbing & Heating, Inc.1
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Gregory
Dovolis
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Sherida
Downer & Paul Downer JTWROS
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
J.
William Doyle
|
105,840
|
78,400
|
27,440
|
—
|
|||||||||
John
Dunkin
|
136,080
|
100,800
|
35,280
|
—
|
|||||||||
Lawrence
J. Elish
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Susan
Gartenberg
|
69,000
|
40,000
|
14,000
|
*
|
|||||||||
Rick
Goad
|
136,080
|
100,800
|
35,280
|
—
|
|||||||||
Granite
Gulf Service Inc.2
|
67,500
|
50,000
|
17,500
|
—
|
|||||||||
Jay
Greenbaum
|
40,500
|
30,000
|
10,500
|
—
|
|||||||||
Robert
Guercio
|
136,080
|
100,800
|
35,280
|
—
|
|||||||||
James
E. Harris
|
204,120
|
151,200
|
52,920
|
—
|
|||||||||
Hendeles
Grandchildren Trust #2 DTD 12/23/933
|
241,998a
|
40,000
|
14,000
|
*
|
|||||||||
Hendeles
Living Trust4
|
241,998a
|
40,000
|
14,000
|
*
|
|||||||||
Moise
Hendeles C/F Arie Hendeles UGMA-CA5
|
203,118a
|
11,200
|
3,920
|
*
|
|
||||||||
Moise
Hendeles C/F Elie Hendeles UGMA-CA6
|
203,118a
|
11,200
|
3,920
|
*
|
|||||||||
Jay
B. Jennings
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Kevin
Anderson Well Drilling LLC7
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Klaus
Kretschmer
|
540,000
|
400,000
|
140,000
|
—
|
|||||||||
Nicholas
B. Kronwall Trust Dated 11/12/698
|
67,500
|
50,000
|
17,500
|
—
|
|||||||||
Lewis
Opportunity Fund, LP9
|
201,666
|
100,000
|
35,000
|
*
|
|||||||||
Linden
Growth Partners Master Fund, LP10
|
604,800
|
448,000
|
156,800
|
—
|
|||||||||
S.
Alan Lisenby
|
272,160
|
201,600
|
70,560
|
—
|
|||||||||
Milstein
Family L.P.11
|
414,166
|
50,000
|
17,500
|
*
|
|||||||||
Richard
A. Mullen
|
302,400
|
224,000
|
78,400
|
—
|
|||||||||
Susan
Newton & Harry Newton, JTWROS
|
335,000
|
100,000
|
35,000
|
*
|
|||||||||
Lawrence
O'Brien
|
136,080
|
100,800
|
35,280
|
—
|
|||||||||
Michael
O'Brien
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Alan
Platner
|
95,580
|
70,800
|
24,780
|
—
|
|||||||||
David
N. Porter
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
David
G. & Nancy Pudelsky
|
113,400
|
84,000
|
29,400
|
—
|
Selling
Stockholder
|
Shares
Beneficially
Owned
Before
Offering
|
Number
of
Outstanding
Shares
Offered
by Selling
Stockholder
|
Number
of
Shares
Offered
by
Selling
Stockholder
upon
Exercise
of
Certain
Warrants
|
Percentage
Beneficial
Ownership
After
Offering
|
|||||||||
Stephen
C. Rabbitt
|
136,080
|
100,800
|
35,280
|
—
|
|||||||||
Louis
Reif
|
272,160
|
201,600
|
70,560
|
—
|
|||||||||
Riverside
Contracting, LLC12
|
409,227
|
200,000
|
70,000
|
*
|
|||||||||
Mitchell
Sayer
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Suzanne
Schiller
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Martin
B. Seretean
|
270,000
|
200,000
|
70,000
|
—
|
|||||||||
William
S. Silver
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
The
Silverman 1984 Trust UAD 5/20/8413
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Lucille
Slocum
|
151,200
|
112,000
|
39,200
|
—
|
|||||||||
Gary
Speet and Linda Speet
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Richard
H. Spurlock
|
135,000
|
100,000
|
35,000
|
—
|
|||||||||
Raymond
L. Stanley, Jr.
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Howard
M. Tanning
|
415,800
|
308,000
|
107,800
|
—
|
|||||||||
Carolyn
Taylor
|
90,720
|
67,200
|
23,520
|
—
|
|||||||||
Tokenhouse
Trading PTE, Ltd.14
|
589,165
|
150,000
|
52,500
|
*
|
|||||||||
Rick
Van Den Toorn
|
108,000
|
80,000
|
28,000
|
—
|
|||||||||
Venturetek,
LP15
|
675,000
|
500,000
|
175,000
|
—
|
|||||||||
Jeffrey
G. Weil
|
204,120
|
151,200
|
52,920
|
—
|
|||||||||
Thomas
Wells
|
136,080
|
100,800
|
35,280
|
—
|
|||||||||
Olen
C. Wilson
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
Thomas
W. Worden
|
68,040
|
50,400
|
17,640
|
—
|
|||||||||
American
Portfolios Financial Services, Inc.
|
6,262
|
—
|
6,262
|
—
|
|||||||||
Benjamin
Brissi
|
4,297
|
—
|
4,297
|
—
|
|||||||||
Annette
Cassella
|
2,500
|
—
|
2,500
|
—
|
|||||||||
Basil
Christakos
|
1,050
|
—
|
1,050
|
—
|
|||||||||
Laureen
Conversano
|
1,100
|
—
|
1,100
|
—
|
|||||||||
Vincent
D’Albora
|
5,000
|
—
|
5,000
|
—
|
|||||||||
Alan
Ferraro
|
24,435
|
—
|
24,435
|
—
|
|||||||||
GunnAllen
Financial, Inc.
|
60,740
|
—
|
60,740
|
—
|
|||||||||
Gary
S. Hobbib
|
667
|
—
|
667
|
—
|
|||||||||
John
Knox
|
4,300
|
—
|
4,300
|
—
|
|||||||||
Legend
Merchant Group, Inc.
|
1,600
|
—
|
1,600
|
—
|
|||||||||
Harris
Lydon
|
18,263
|
—
|
18,263
|
—
|
|||||||||
Jeffrey
R. Marshall
|
1,166
|
—
|
1,166
|
—
|
|||||||||
Andrew
Miles
|
2,148
|
—
|
2,148
|
—
|
|||||||||
Robert
D. Millstone
|
37,572
|
—
|
37,572
|
—
|
|||||||||
Michael
Mullen
|
108,685
|
—
|
108,685
|
—
|
|||||||||
William
Odenthal
|
1,667
|
—
|
1,667
|
—
|
|||||||||
Joseph
Orlando
|
20,500
|
—
|
20,500
|
—
|
|||||||||
Craig
Pierson
|
2,400
|
—
|
2,400
|
—
|
|||||||||
Ryan
Reed
|
10,000
|
—
|
10,000
|
—
|
|||||||||
Lindsay
A. Rosenwald
|
3,470,999b
|
—
|
45,000
|
6.0
|
|||||||||
Karl
Ruggeberg
|
4,942
|
—
|
4,942
|
—
|
|||||||||
Steven
A. Sherman
|
18,786
|
—
|
18,786
|
—
|
|||||||||
Whitaker
Securities LLC
|
1,500
|
—
|
1,500
|
—
|
|||||||||
Jeff
Woolf
|
10,000
|
—
|
10,000
|
—
|
|||||||||
TOTAL
|
7,891,600
|
3,156,640
|
—
|
·
|
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;
|
·
|
short
sales;
|
·
|
through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise;
|
·
|
broker-dealers
may agree with the selling stockholders to sell a specified number
of such
shares at a stipulated price per share;
|
·
|
a
combination of any such methods of sale; and
|
·
|
any
other method permitted pursuant to applicable
law.
|
|
Page
|
|
Unaudited
Interim Condensed Consolidated Financial Statements of VioQuest
Pharmaceuticals, Inc. and Subsidiaries:
|
||
Condensed
Consolidated Balance Sheets as of September 30, 2006 (unaudited)
and
December 31, 2005
|
F-2
|
|
Condensed
Consolidated Statement of Operations for the Nine Months Ended
September
30, 2006 and 2005 (unaudited)
|
F-3
|
|
Condensed
Consolidated Statements of Changes in Stockholders’ Equity for the Nine
Months Ended September 30, 2006
|
F-4
|
|
Condensed
Consolidated Statements of Cash Flows for the Nine Months Ended
September
30, 2006 and 2005 (unaudited)
|
F-5
|
|
Notes
to Condensed Consolidated Financial Statements
|
F-6-F-11
|
|
Audited
Consolidated Financial Statements of VioQuest Pharmaceuticals,
Inc. and
Subsidiaries:
|
||
Report
of J.H. Cohn LLP
|
F-12
|
|
Consolidated
Balance Sheets as of December 31, 2005 and 2004
|
F-13
|
|
Consolidated
Statements of Operations for the Years Ended December 31, 2005
and 2004
|
F-14
|
|
Consolidated
Statements of Changes in Stockholders’ Equity for the Years Ended
December 31, 2005 and 2004
|
F-15
|
|
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2005
and 2004
|
F-16
|
|
Notes
to Consolidated Financial Statements
|
F-17
to F-29
|
September
30, 2006
(Unaudited)
|
December
31, 2005
(Note
1A)
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
and cash equivalents
|
$
|
823,129
|
$
|
6,021,399
|
|||
Prepaid
clinical research organization costs
|
180,238
|
-
|
|||||
Other
current assets
|
89,054
|
9,945
|
|||||
Current
assets associated with discontinued operations
|
1,269,445
|
892,092
|
|||||
Total
Current Assets
|
2,361,866
|
6,923,436
|
|||||
NON-CURRENT
ASSETS ASSOCIATED WITH DISCONTINUED OPERATIONS
|
1,336,484
|
1,424,883
|
|||||
PROPERTY
AND EQUIPMENT, NET
|
31,191
|
21,276
|
|||||
SECURITY
DEPOSITS
|
9,708
|
9,708
|
|||||
TOTAL
ASSETS
|
$
|
3,739,249
|
$
|
8,379,303
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
612,044
|
$
|
275,077
|
|||
Accrued
compensation
|
213,609
|
346,833
|
|||||
Accrued
expenses
|
267,405
|
48,167
|
|||||
Note
payable - Paramount BioCapital
|
264,623
|
264,623
|
|||||
Current
liabilities associated with discontinued operations
|
769,669
|
1,105,594
|
|||||
TOTAL
LIABILITIES
|
2,127,350
|
2,040,294
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
STOCKHOLDERS'
EQUITY
|
|||||||
Preferred
stock; $0.001 par value: 10,000,000 shares authorized, 0 shares
issued and
outstanding at September 30, 2006 and December 31, 2005
|
-
|
-
|
|||||
Common
stock; $0.001 par value: 100,000,000 shares authorized at September
30,
2006 and December 31, 2005, 46,729,519 shares issued and outstanding
at
September 30, 2006 and December 31, 2005
|
46,729
|
46,729
|
|||||
Additional
paid-in capital
|
27,399,677
|
26,561,672
|
|||||
Accumulated
deficit
|
(25,834,507
|
)
|
(20,269,392
|
)
|
|||
Total
Stockholders' Equity
|
1,611,899
|
6,339,009
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
3,739,249
|
$
|
8,379,303
|
For
the Nine Months Ended September 30, 2006
|
For
the Nine
Months
Ended September 30, 2005
|
||||||
REVENUE
|
$
|
-
|
$
|
-
|
|||
OPERATING
EXPENSES
|
|||||||
Research
and development
|
933,599
|
-
|
|||||
Selling,
general and administrative
|
2,348,030
|
1,704,940
|
|||||
Total
Operating Expenses
|
3,281,629
|
1,704,940
|
|||||
LOSS
FROM CONTINUING OPERATIONS
|
(3,281,629
|
)
|
(1,704,940
|
)
|
|||
INTEREST
INCOME, NET
|
85,361
|
14,203
|
|||||
LOSS
FROM CONTINUING OPERATIONS
|
(3,196,268
|
)
|
(1,690,737
|
)
|
|||
LOSS
FROM DISCONTINUED OPERATIONS
|
(2,368,847
|
)
|
(2,372,397
|
)
|
|||
NET
LOSS
|
$
|
(5,565,115
|
)
|
$
|
(4,063,134
|
)
|
|
NET
LOSS PER COMMON SHARE:
|
|||||||
CONTINUING
OPERATIONS
|
$
|
(0.08
|
)
|
$
|
(0.09
|
)
|
|
DISCONTINUED
OPERATIONS
|
(0.07
|
)
|
(0.14
|
)
|
|||
BASIC
LOSS PER SHARE
|
$
|
(0.15
|
)
|
$
|
(0.23
|
)
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING - BASIC AND DILUTED
|
38,165,124
|
17,852,100
|
Common
Stock
|
Additional
Paid-In
|
Accumulated
|
Total
Stockholders’
|
|||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Equity
|
||||||||||||
Balance,
January 1, 2006
|
46,729,519
|
$
|
46,729
|
$
|
26,561,672
|
$
|
(20,269,392
|
)
|
$
|
6,339,009
|
||||||
Employee
and director
stock-based compensation
|
—
|
—
|
749,680
|
—
|
749,680
|
|||||||||||
Stock-based
compensation to consultants
|
—
|
—
|
88,325
|
—
|
88,325
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
(5,565,115
|
)
|
(5,565,115
|
)
|
|||||||||
Balance,
September 30, 2006
|
46,729,519
|
$
|
46,729
|
$
|
27,399,677
|
$
|
(25,834,507
|
)
|
$
|
1,611,899
|
For
the Nine
Months
Ended
September
30, 2006
|
For
the Nine
Months
Ended
September
30, 2005
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(5,565,115
|
)
|
$
|
(4,063,134
|
)
|
|
Loss
from discontinued operations
|
2,368,847
|
2,372,397
|
|||||
Loss
from continuing operations
|
(3,196,268
|
)
|
(1,690,737
|
)
|
|||
Adjustments
to reconcile net loss from continuing operations to net cash used
in
continuing operating activities:
|
|||||||
Depreciation
and amortization
|
3,804
|
2,149
|
|||||
Impact
of employee and director stock-based compensation
|
589,673
|
-
|
|||||
Impact
of consultant stock-based compensation
|
33,119
|
190,000
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Prepaid
clinical research organization costs
|
(180,238
|
)
|
-
|
||||
Other
assets
|
(79,109
|
)
|
(80,041
|
)
|
|||
Accounts
payable
|
336,967
|
437,749
|
|||||
Accrued
compensation
|
(133,224
|
)
|
139,000
|
||||
Accrued
expenses
|
219,238
|
-
|
|||||
Net
Cash Used in Continuing Operating Activities
|
(2,406,038
|
)
|
(1,001,880
|
)
|
|||
Net
Cash Used in Discontinued Operating Activities
|
(2,633,511
|
)
|
(1,247,322
|
)
|
|||
Net
Cash Used in Operating Activities
|
(5,039,549
|
)
|
(2,249,202
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Payments
for purchased equipment
|
(14,987
|
)
|
(18,529
|
)
|
|||
Net
Cash Used in Continuing Investing Activities
|
(14,987
|
)
|
(18,529
|
)
|
|||
Net
Cash Used in Discontinued Investing Activities
|
(143,734
|
)
|
(536,034
|
)
|
|||
Net
Cash Used in Investing Activities
|
(158,721
|
)
|
(554,563
|
)
|
|||
NET
DECREASE IN CASH AND CASH EQUIVALENTS
|
(5,198,270
|
)
|
(2,803,765
|
)
|
|||
CASH
AND CASH EQUIVALENTS - BEGINNING OF PERIOD
|
6,021,399
|
3,065,547
|
|||||
CASH
AND CASH EQUIVALENTS - END OF PERIOD
|
$
|
823,129
|
$
|
261,782
|
|
Nine
Months Ended September
30, 2005
|
|||
Loss
from continuing operations
|
$
|
(1,690,737
|
)
|
|
Deduct:
Stock-based employee compensation
|
||||
expense
determined under fair value based
|
||||
method
for all awards, net of taxes
|
(198,769
|
)
|
||
Pro
forma, loss from continuing operations
|
$
|
(1,889,506
|
)
|
|
Loss
from discontinued operations
|
(2,372,397
|
)
|
||
Deduct:
Stock-based employee compensation
|
||||
expense
determined under fair value based
|
||||
method
for all awards, net of taxes
|
(187,035
|
)
|
||
Pro
forma, loss from discontinued operations
|
(2,559,432
|
)
|
||
Pro
forma, net loss
|
$
|
(4,448,938
|
)
|
|
Basic
and diluted loss per share from continuing operations, as
reported
|
$
|
(0.09
|
)
|
|
Basic
and diluted loss per share from continuing operations, pro
forma
|
$
|
(0.11
|
)
|
|
Basic
and diluted loss per share from discontinued operations, as
reported
|
$
|
(0.14
|
)
|
|
Basic
and diluted loss per share from discontinued operations, pro
forma
|
$
|
(0.14
|
)
|
|
Basic
and diluted net loss per share, as reported
|
$
|
(0.23
|
)
|
|
Basic
and diluted net loss per share, pro forma
|
$
|
(0.25
|
)
|
|
Nine
Months Ended September
30,
|
||||||
|
2006
|
2005
|
|||||
Term
|
7
years
|
10
years
|
|||||
Volatility
|
210%-217%
|
|
108%-157%
|
|
|||
Dividend
yield
|
0.0%
|
|
0.0%
|
|
|||
Risk-free
interest rate
|
4.37%-4.96%
|
|
4.1%-4.4%
|
|
|||
Forfeiture
rate
|
22%-25%
|
|
0%
|
|
Number
of Options
|
Weighted
Average Exercise Price
|
Weighted
Average Remaining Contractual Life
|
Aggregate
Intrinsic Value
|
||||||||||
Balance,
January 1, 2006
|
4,975,852
|
$
|
1.10
|
||||||||||
Options
granted
|
1,212,000
|
$
|
0.83
|
||||||||||
Options
cancelled
|
(386,000
|
)
|
$
|
0.89
|
|||||||||
Options
outstanding, September 30, 2006
|
5,801,852
|
$
|
1.05
|
7.2
|
$
|
2,523,591
|
|||||||
Options
exercisable, September 30, 2006
|
2,108,282
|
$
|
1.28
|
5.8
|
$
|
190,670
|
|
Nine
Months Ended September
30, 2005
|
|||
Net
loss
|
$
|
(11,924
|
)
|
|
Basic
and diluted net loss per share, as reported
|
$
|
(0.31
|
)
|
|
Weighted
average common shares outstanding - basic and diluted
|
37,965
|
|
2005
|
2004
|
|||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|
|
|||||
Cash
and cash equivalents
|
$
|
6,021,399
|
$
|
3,065,547
|
|||
Other
current assets
|
9,945
|
-
|
|||||
Current
assets associated with discontinued operations
|
892,092
|
743,109
|
|||||
Total
Current Assets
|
6,923,436
|
3,808,656
|
|||||
|
|||||||
NON-CURRENT
ASSETS ASSOCIATED WITH DISCONTINUED OPERATIONS
|
1,424,883
|
1,068,085
|
|||||
|
|||||||
PROPERTY
AND EQUIPMENT, NET
|
21,276
|
-
|
|||||
SECURITY
DEPOSITS
|
9,708
|
-
|
|||||
TOTAL
ASSETS
|
$
|
8,379,303
|
$
|
4,876,741
|
|||
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
275,077
|
$
|
-
|
|||
Accrued
compensation and related taxes
|
346,833
|
-
|
|||||
Accrued
expenses
|
48,167
|
-
|
|||||
Note
payable - Paramount BioCapital
|
264,623
|
—
|
|||||
Liabilities
associated with discontinued operations
|
1,105,594
|
1,086,949
|
|||||
TOTAL
LIABILITIES
|
2,040,294
|
1,086,949
|
|||||
|
|||||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
|
|||||||
STOCKHOLDERS'
EQUITY
|
|||||||
Preferred
stock; $0.001 par value: 10,000,000 shares authorized, 0 shares
issued and
outstanding at December 31, 2005 and 2004
|
—
|
—
|
|||||
Common
stock; $0.001 and $0.01 par value: 100,000,000 and 50,000,000 shares
authorized at December 31, 2005 and 2004 respectively, 46,729,519
shares
issued and outstanding at December 31, 2005, and 17,827,924 shares
issued
and outstanding at December 31, 2004
|
46,729
|
178,279
|
|||||
Additional
paid-in capital
|
26,561,672
|
11,046,276
|
|||||
Accumulated
deficit
|
(20,269,392
|
)
|
(7,434,763
|
)
|
|||
Total
Stockholders' Equity
|
6,339,009
|
3,789,792
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
8,379,303
|
$
|
4,876,741
|
|
2005
|
2004
|
|||||
|
|
|
|||||
REVENUE
|
$
|
-
|
$
|
-
|
|||
|
|||||||
OPERATING
EXPENSES
|
|||||||
In-process
research and development
|
7,975,218
|
-
|
|||||
Selling,
general and administrative
|
2,796,037
|
-
|
|||||
Total
Operating Expenses
|
(10,771,255
|
)
|
-
|
||||
LOSS
FROM CONTINUING OPERATIONS
|
(10,771,255
|
)
|
-
|
||||
INTEREST
INCOME, NET
|
42,422
|
-
|
|||||
LOSS
FROM CONTINUING OPERATIONS
|
(10,728,833
|
)
|
-
|
||||
LOSS
FROM DISCONTINUED OPERATIONS, NET OF TAX BENEFIT
|
(2,105,796
|
)
|
(4,023,558
|
)
|
|||
NET
LOSS
|
$
|
(12,834,629
|
)
|
$
|
(4,023,558
|
||
NET
LOSS PER COMMON SHARE:
|
|||||||
CONTINUING
OPERATIONS
|
$
|
(0.49
|
)
|
$
|
(0.00
|
)
|
|
DISCONTINUED
OPERATIONS
|
(0.09
|
)
|
(0.24
|
)
|
|||
BASIC
LOSS PER SHARE
|
$
|
(0.58
|
)
|
$
|
(0.24
|
)
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING - BASIC AND DILUTED
|
22,034,198
|
17,100,582
|
|
Common
Stock
|
Additional
Paid-In
|
Accumulated
|
Total
Stockholders’
|
||||||||||||
|
Shares
|
Amount
|
Capital
|
Deficit
|
Equity
|
|||||||||||
Balance,
January 1, 2004
|
13,001,018
|
$
|
130,010
|
$
|
4,106,529
|
$
|
(3,411,205
|
)
|
$
|
825,334
|
||||||
February
25, 2004 private placement, net of $548,728 in financing
costs
|
4,826,906
|
48,269
|
6,643,362
|
6,691,631
|
||||||||||||
Stock-based
compensation to consultants
|
296,385
|
296,385
|
||||||||||||||
Net
loss for the year ended December 31, 2004
|
(4,023,558
|
)
|
(4,023,558
|
)
|
||||||||||||
Balance,
December 31, 2004
|
17,827,924
|
178,279
|
11,046,276
|
(7,434,763
|
)
|
3,789,792
|
||||||||||
Common
stock issued to consultant
|
200,000
|
200
|
189,800
|
190,000
|
||||||||||||
October
18, 2005 private placement, net of $636,949 in financing
costs
|
11,179,975
|
11,180
|
7,736,852
|
7,748,032
|
||||||||||||
October
18, 2005 acquisition of Greenwich Therapeutics, Inc. (includes
8,564,395
shares held in escrow - see Note 3)
|
17,128,790
|
17,129
|
6,993,985
|
7,011,114
|
||||||||||||
Shares
issued for repayment of debt to Paramount BioCapital, Inc.
|
392,830
|
392
|
264,231
|
264,623
|
||||||||||||
Stock-based
compensation to consultants
|
170,077
|
170,077
|
||||||||||||||
Effect
of change in par value from change in state of incorporation
|
(160,451
|
)
|
160,451
|
—
|
||||||||||||
Net
loss for the year ended December 31, 2005
|
(12,834,629
|
)
|
(12,834,629
|
)
|
||||||||||||
Balance,
December 31, 2005
|
46,729,519
|
46,729
|
$
|
26,561,672
|
$
|
(20,269,392
|
)
|
$
|
6,339,009
|
2005
|
2004
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|||||
Net
loss
|
$
|
(12,834,629
|
)
|
$
|
(4,023,558
|
)
|
|
Loss
from discontinued operations
|
2,105,796
|
4,023,558
|
|||||
Loss
from continuing operations
|
|
(10,728,833
|
)
|
|
-
|
||
Adjustments
to reconcile net loss from continuing operations to net cash used
in
continuing operating activities:
|
|||||||
In-process
research and development
|
7,975,218
|
—
|
|||||
Depreciation
and amortization
|
1,787
|
-
|
|||||
Stock
issued for services
|
190,000
|
-
|
|||||
Changes
in operating assets and liabilities:
|
-
|
||||||
(Increase)
in other current assets
|
(10,020
|
)
|
-
|
||||
(Increase)
in security deposits
|
(9,708
|
)
|
-
|
||||
Increase
in accounts payable
|
275,077
|
-
|
|||||
Increase
in accrued expenses
|
395,000
|
-
|
|||||
Net
Cash Used In Continuing Operating Activities
|
(1,911,479
|
)
|
-
|
||||
Net
Cash Used In Discontinued Operating Activities
|
(1,830,375
|
)
|
(3,786,173
|
)
|
|||
Net
Cash Used In Operating Activities
|
(3,741,854
|
)
|
(3,786,173
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Payments
for Greenwich acquisition
|
(170,234
|
)
|
—
|
||||
Payments
for purchased property and equipment
|
(23,063
|
)
|
-
|
||||
Net
Cash Used In Continuing Investing Activities
|
(193,297
|
)
|
-
|
||||
Net
Cash Used In Discontinued Investing Activities
|
(592,406
|
)
|
(549,029
|
)
|
|||
Net
Cash Used In Investing Activities
|
(785,703
|
)
|
(549,029
|
)
|
|||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from private placement of common stock, net
|
7,748,032
|
6,741,632
|
|||||
Payment
of note payable to Paramount BioCapital
|
(264,623
|
)
|
—
|
||||
Net
Cash Provided By Continuing Financing Activities
|
7,483,409
|
6,741,632
|
|||||
NET
INCREASE IN CASH AND CASH EQUIVALENTS
|
2,955,852
|
2,406,430
|
|||||
CASH
AND CASH EQUIVALENTS - BEGINNING OF YEAR
|
3,065,547
|
659,117
|
|||||
CASH
AND CASH EQUIVALENTS - END OF YEAR
|
$
|
6,021,399
|
$
|
3,065,547
|
|||
Supplemental
Schedule of Non-Cash Investing and Financing Activities:
|
|||||||
Reclassification
of deferred financing costs to additional paid-in capital in connection
with private placement
|
$
|
—
|
$
|
50,000
|
|
Year
Ended
December
31, 2005
|
Year
Ended
December
31, 2004
|
|||||
Loss
from continuing operations as reported
|
$
|
(10,728,833
|
)
|
$
|
(0
|
)
|
|
Deduct: Stock-based
employee compensation
|
|||||||
expense
determined under fair value based
|
|||||||
method
for all awards, net of taxes
|
(466,991
|
)
|
(0
|
)
|
|||
Pro
forma, loss from continuing operations
|
$
|
(11,195,824
|
)
|
$
|
(0
|
)
|
|
Loss
from discontinued operations as reported
|
(2,105,796
|
)
|
(4,023,558
|
)
|
|||
Deduct: Stock-based
employee compensation
|
|||||||
expense
determined under fair value based
|
|||||||
method
for all awards, net of taxes
|
(236,781
|
)
|
(315,003
|
)
|
|||
Pro
forma, loss from discontinued operations
|
(2,342,577
|
)
|
(4,338,561
|
)
|
|||
Pro
forma, net loss
|
$
|
(13,538,401
|
)
|
$
|
(4,338,561
|
)
|
|
Basic
and diluted loss per share from continuing operations, as
reported
|
$
|
(0.49
|
)
|
$
|
(0.00
|
)
|
|
Basic
and diluted loss per share from continuing operations, pro
forma
|
$
|
(0.51
|
)
|
$
|
(0.00
|
)
|
|
Basic
and diluted loss per share from discontinued operations, as
reported
|
$
|
(0.09
|
)
|
$
|
(0.24
|
)
|
|
Basic
and diluted loss per share from discontinued operations, pro
forma
|
$
|
(0.11
|
)
|
$
|
(0.25
|
)
|
|
Basic
and diluted loss per share, as reported
|
$
|
(0.58
|
)
|
$
|
(0.24
|
)
|
|
Basic
and diluted net loss per share, pro forma
|
$
|
(0.62
|
)
|
$
|
(0.25
|
)
|
|
December
31,
2005
|
December
31,
2004
|
|||||
Risk-free
interest rate
|
3%-5
|
%
|
3%-5
|
%
|
|||
Volatility
|
108%-175
|
%
|
39%-98
|
%
|
|||
Lives
in years
|
10
|
10
|
|||||
Dividend
yield
|
0
|
%
|
0
|
%
|
|
(i)
|
35%
of the escrowed securities shall be released upon the conclusion
of a
Phase I clinical trial pursuant to an investigational new drug
application
(“IND”) accepted by the U.S. Food and Drug Administration (“FDA”) for
VQD-001 or SSG;
|
|
(ii)
|
15%
of the escrowed securities shall be released immediately upon conclusion
of a Phase II clinical trial for VQD-001 or SSG under a Company-sponsored
IND; provided that a majority of the members of the Company’s then
existing medical advisory board conclude that such trial yielded
results
which, in the opinion of such advisory board, warrant initiation
of Phase
III trial(s) (provided that this milestone shall be deemed to have
been
satisfied in the event a new drug application, or NDA, relating
to VQD-001
or SSG has been accepted for review by the FDA prior to any determination
by the medical advisory board to initiate a Phase III
trial);
|
(iii)
|
35%
of such escrowed securities shall be released immediately upon
the
conclusion of a Phase I clinical trial pursuant to a Company-sponsored
IND
application accepted by the FDA for VQD-002 or TCN-P;
|
|
(iv)
|
15%
of such escrowed securities shall be released immediately upon
conclusion
of a Phase II clinical trial for VQD-002 or TCN-P under a
Company-sponsored IND; provided that a majority of the members
of the
Company’s then existing medical advisory board conclude that such trial
yielded results which, in the opinion of such advisory board, warrant
initiation of Phase III trial(s) (provided that this milestone
shall be
deemed to have been satisfied in the event an NDA relating to VQD-002
or
has been accepted for review by the FDA prior to any determination
by the
medical advisory board to initiate a Phase III trial).
|
|
|
|||
Common
stock issued, excluding contingent shares*
|
$
|
5,995
|
||
Warrants
issued, excluding contingent warrants*
|
986
|
|||
Liabilities
assumed
|
824
|
|||
Transaction
costs
|
170
|
|||
Total
purchase price
|
$
|
7,975
|
*
|
The
purchase price does not include any of the contingent achievement-based
milestone payments described above.
|
|
Pro
Forma (Unaudited)
|
||||||
|
Years
Ended December 31,
|
||||||
|
2005
|
2004
|
|||||
-
|
|||||||
LOSS
FROM CONTINUING OPERATIONS
|
$
|
(11,483,735
|
)
|
$
|
(68,967
|
)
|
|
LOSS
FROM CONTINUING OPERATIONS BASIC AND DILUTED PER COMMON SHARE
|
$
|
(0.39
|
)
|
$
|
(0.00
|
)
|
|
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING - BASIC AND DILUTED
|
29,150,897
|
25,664,977
|
|
December
31, 2005
|
December
31, 2004
|
|||||
Office
equipment
|
$
|
18,185
|
$
|
-
|
|||
Computer
equipment
|
4,878
|
-
|
|||||
Property
and equipment
|
23,063
|
-
|
|||||
Less
accumulated depreciation and amortization
|
1,787
|
-
|
|||||
Property
and Equipment, Net
|
$
|
21,276
|
$
|
-
|
|
Year
Ended December 31,
|
||||||
|
2005
|
2004
|
|||||
NOL
carryforwards - Federal
|
$
|
4,111,000
|
$
|
2,439,493
|
|||
NOL
carryforwards - State
|
160,000
|
430,507
|
|||||
Excess
tax basis of Greenwich
|
3,190,000
|
-
|
|||||
Other,
net
|
(21,000
|
)
|
-
|
||||
Valuation
allowance
|
(7,440,000
|
)
|
(2,870,000
|
)
|
|||
Net
deferred tax assets
|
$
|
-
|
$
|
-
|
|
December
31, 2005
|
December
31, 2004
|
|||||
Income
tax benefit at statutory rate
|
$
|
(3,648,000
|
)
|
$
|
-
|
||
State
income taxes net of Federal tax
|
(324,000
|
)
|
-
|
||||
Increase
in valuation allowance
|
3,972,000
|
-
|
|||||
$
|
-
|
$
|
-
|
|
December
31, 2005
|
December
31, 2004
|
|||||||||||
|
|
Weighted
|
|
Weighted
|
|||||||||
|
|
Average
|
|
Average
|
|||||||||
|
|
Exercise
|
|
Exercise
|
|||||||||
|
Shares
|
Price
|
Shares
|
Price
|
|||||||||
Outstanding
at beginning of year
|
2,244,877
|
$
|
1.42
|
2,841,607
|
$
|
1.47
|
|||||||
Granted
|
3,079,475
|
$
|
0.90
|
366,000
|
$
|
1.22
|
|||||||
Expired
|
(348,500
|
)
|
$
|
1.41
|
(962,730
|
)
|
$
|
1.49
|
|||||
Outstanding
at end of year
|
4,975,852
|
$
|
1.10
|
2,244,877
|
$
|
1.42
|
|||||||
Options
exercisable at year-end
|
1,170,121
|
$
|
1.36
|
1,024,488
|
$
|
1.38
|
|||||||
Weighted-average
fair value of options granted during the year
|
$
|
0.86
|
$
|
1.14
|
Range
of Exercise
Prices
|
Outstanding
Options
|
Weighted
Average Exercise Price
|
Weighted
Average Remaining Life In Years
|
|||||||
$.01-$0.99
|
2,694,475
|
$
|
0.88
|
10
|
||||||
$1.00-$1.99
|
2,268,252
|
$
|
1.35
|
8
|
||||||
$2.00-$2.99
|
10,000
|
$
|
2.17
|
4
|
||||||
$3.00-$3.99
|
875
|
$
|
3.20
|
1
|
||||||
$4.00-$12.00
|
2,250
|
$
|
7.29
|
0
|
||||||
Total
|
4,975,852
|
Remaining
Contractual Life
In Years
|
Price
|
Number
of Outstanding Warrants
|
|||||
4.75
|
$
|
1.00
|
5,589,987
|
(A)
|
|||
4.75
|
$
|
1.41
|
4,000,000
|
(B)
|
|||
3.15
|
$
|
1.65
|
2,896,132
|
(C)
|
|||
|
12,486,119
|
(A) - |
Warrants
issued as a result of the Company’s private placement of its common stock
in October 2005 to investors and Paramount BioCapital, Inc. of
4,471,990
and 1,117,997, respectively. All warrants are exercisable as of
December
31, 2005.
|
(B) -
|
Warrants
issued as a result of the merger with Greenwich. In connection
with the
escrow agreement (see Note 3), one-half of the warrants are exercisable
upon the achievement of certain clinical milestones, and the other
half of
the warrants are exercisable within one year from the merger date
of
October 18, 2005.
|
(C) -
|
Warrants
issued to investors of the Company’s private placement of its common stock
in February 2004. All warrants are exercisable as of December 31,
2005.
|
|
Years
ended
December
31,
|
|||
2006
|
$
|
378,000
|
||
2007
|
384,000
|
|||
2008
|
371,000
|
|||
2009
|
138,000
|
|||
|
$
|
1,271,000
|