Unassociated Document
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-KSB
x
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Annual
Report pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934 for the fiscal year ended December 31,
2006
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o
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Transition
Report pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934 for the transition period from _________ to
_________
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Commission
File Number 0-16686
VIOQUEST
PHARMACEUTICALS, INC.
(Exact
name of issuer as specified in its charter)
Delaware
(State
or other jurisdiction of incorporation or organization)
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58-1486040
(IRS
Employer Identification No.)
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180
Mt. Airy Road, Suite 102, Basking Ridge, NJ
(Address
of Principal Executive Offices)
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07920
(Zip
Code)
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(908)
766-4400
(Issuer’s
telephone number)
Securities
registered pursuant to Section 12(b) of the Exchange Act:
None
Securities
registered pursuant to Section 12(g) of the Exchange Act:
Common
Stock, par value $0.001
|
Check
whether the issuer is not required to file reports pursuant to Section 13 or
15(d) of the Exchange Act. o
Check
whether the issuer: (1) filed all reports required to be filed by Section 13
or
15(d) of the Securities Exchange Act of 1934 during the past 12 months (or
for
such shorter period that the issuer was required to file such reports), and
(2)
has been subject to such filing requirements for the past 90 days. x
Yes o
No
Check
if
there is no disclosure of delinquent filers pursuant to Item 405 of Regulation
S-B is not contained herein, and no disclosure will be contained, to the best
of
registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-KSB or any amendment
to
this Form 10-KSB. o
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o
No
x
For
its
fiscal year ended December 31, 2006, the issuer had $0 revenue from continuing
operations and, together with its discontinued operations, the issuer had total
revenue of $2,738,652.
The
aggregate market value of the issuer’s common stock held by non-affiliates as of
March 19, 2007, based on the closing price of the common stock as reported
on
the OTC Bulletin Board on such date, was $20,616,374.
As
of
March 19, 2007 there were outstanding 54,621,119 shares of common stock, par
value $0.001 per share.
Traditional
Small Business Disclosure Format: Yes o
No
x
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of the issuer’s definitive Proxy Statement for its Annual Meeting of
Stockholders to be held on May 24, 2007 (the “2007 Proxy Statement”) are
incorporated by reference into Part III of this Form 10-KSB, to the extent
described in Part III. The 2007 Proxy Statement will be filed within 120 days
after the fiscal year ended December 31, 2006.
TABLE
OF CONTENTS
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Page
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PART
I
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Item
1
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Description
of Business
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1
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Item
2
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Legal
Proceedings
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17
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Item
3
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Description
of Property
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17
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Item
4
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Submission
of Matters to a Vote of Security Holders
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18
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PART
II
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Item
5
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Market
for Common Equity and Related Stockholder Matters
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19
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Item
6
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Management’s
Discussion and Analysis of Financial Condition and Results of Operations
or Plan of Operations
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20
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Item
7
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Consolidated
Financial Statements
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28
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Item
8
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Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
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28
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Item
8A
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Controls
and Procedures
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28
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Item
8B
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Other
Information
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28
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PART
III
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Item
9
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Directors,
Executive Officers, Promoters and Control Persons; Compliance with
Section
16(a) of the Exchange Act
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29
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Item
10
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Executive
Compensation
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29
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Item
11
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Security
Ownership of Certain Beneficial Owners and Management and Related
Stockholders’ Matters
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29
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Item
12
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Certain
Relationships and Related Transactions
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29
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Item
13
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Exhibit
List
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29
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Item
14
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Principal
Accountant Fees and Services
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31
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Signatures
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32
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Index
to Consolidated Financial Statements
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F-1
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References
to the “Company,” the “Registrant,” “we,” “us,” “our” or in this Annual Report
on Form 10-KSB refer to VioQuest Pharmaceuticals, Inc., a Delaware corporation,
and its consolidated subsidiaries, together taken as a whole, unless the context
indicates otherwise.
Forward-Looking
Statements
This
Annual Report on Form 10-KSB includes forward-looking statements. These
forward-looking statements involve a number of risks and uncertainties. Such
forward-looking statements include statements about our strategies, intentions,
expectations, goals, objectives, discoveries, collaborations, clinical programs,
future achievements and other statements that are not historical facts. These
forward-looking statements can generally be identified as such because the
context of the statement will include words such as “may,” “will,” “intends,”
“plans,” “believes,” “anticipates,” “expects,” “estimates,” “predicts,”
“potential,” “continue,” “likely,” or “opportunity,” the negative of these words
or other similar words. Readers of this Annual Report on Form 10-KSB are
cautioned not to place undue reliance on these forward-looking statements,
which
speak only as of the time this Annual Report on Form 10-KSB was filed with
the
Securities and Exchange Commission, or SEC. These forward-looking statements
are
based largely on our expectations and projections about future events and future
trends affecting our business, and are subject to risks and uncertainties that
could cause actual results to differ materially from those anticipated in the
forward-looking statements. These risks and uncertainties include, without
limitation, those discussed under the heading “Risk Factors” following “Item 1.
Description of Business,” and in “Item 6. Management’s Discussion and Analysis
of Financial Condition and Results of Operations or Plan of Operation” of this
Annual Report on Form 10-KSB. In addition, past financial or operating
performance is not necessarily a reliable indicator of future performance and
you should not use our historical performance to anticipate results or future
period trends. We can give no assurances that any of the events anticipated
by
the forward-looking statements will occur or, if any of them do, what impact
they will have on our results of operations and financial condition. Except
as
required by law, we undertake no obligation to publicly revise our
forward-looking statements to reflect events or circumstances that arise after
the filing of this Annual Report on Form 10-KSB or documents incorporated by
reference herein that include forward-looking statements
PART
I
ITEM
1. DESCRIPTION OF BUSINESS
Overview
Since
October 2005, VioQuest Pharmaceuticals, Inc. has had two distinct business
units
- Drug Development and Chiral Products and Services. Our drug development
business focuses on acquiring, developing and eventually commercializing human
therapeutics in the areas of oncology, and antiviral diseases and disorders
for
which there are current unmet medical needs. We currently have the exclusive
rights to develop and commercialize two oncology drug candidates. We have
initiated three Phase I/IIa clinical trials since acquiring the license rights
to VQD-001 and VQD-002. Our chiral business, which we operate through our
wholly-owned subsidiary, Chiral Quest, Inc., provides innovative chiral
products, technology and custom synthesis development services to pharmaceutical
and fine chemical companies in all stages of a products’ lifecycle. In September
2006, our board of directors directed our management to explore strategic
alternatives relating to our chiral business, including the possible sale of
the
business. As a result, for accounting purposes, our chiral chemistry business
is
presented as discontinued operations in our financial statements, including
our
audited financial statements as of and for the year ended December 31, 2006
included elsewhere in this Annual Report on Form 10-KSB.
Corporate
History; Mergers and Reincorporation Transactions
We
were
originally formed in October 2000, as a Pennsylvania limited liability company
under the name Chiral Quest, LLC. In February 2003, we completed a reverse
acquisition of Surg II, Inc., a publicly-held Minnesota shell corporation and
were renamed Chiral Quest, Inc. In August 2004, we changed our name to VioQuest
Pharmaceuticals, Inc. In October 2005, we reincorporated under Delaware law
by
merging into a wholly-owned subsidiary incorporated under Delaware law.
Immediately
following the reincorporation, we acquired Greenwich Therapeutics, Inc., a
privately-held, New York City based drug development company, in a merger
transaction in which we merged a wholly-owned subsidiary with and into Greenwich
Therapeutics, with Greenwich Therapeutics remaining as the surviving corporation
and our wholly-owned subsidiary. As a result of the acquisition of Greenwich
Therapeutics, we acquired the rights to develop and commercialize two oncology
drug candidates - VQD-001, Sodium Stibogluconate, or SSG, and VQD-002,
Triciribine-Phosphate, or TCN-P.
Drug
Development
Through
our drug development business, we acquire, develop, and intend to commercialize
innovative products for the treatment of important unmet medical needs in cancer
and immunological diseases. Through our acquisition of Greenwich Therapeutics,
Inc. in October 2005, we obtained the rights to develop and commercialize two
oncology drug candidates - VQD-001 and VQD-002. We hold our rights to VQD-001
and VQD-002, pursuant to license agreements with The Cleveland Clinic
Foundation and the University of South Florida Research Foundation,
respectively. These licenses give us the right to develop, manufacture, use,
commercialize, lease, sell and/or sublicense VQD-001 and VQD-002. We have
initiated three Phase I/IIa clinical trials since acquiring the license rights
to VQD-001 and VQD-002.
Cancer
Overview
Cancer
develops when abnormal cells in the body begin to grow out of control. These
cancer cells may outlive normal cells and can go on to form additional cancerous
cells. The danger is that these cells may often travel to other parts of the
body and replace normal tissue, a process called metastasis. Frequently, these
metastases ultimately lead to a patient’s death. Although the exact cause of
cancer is still uncertain, it is believed that genetics and environmental toxins
play a role.
The
American Cancer Society estimates that 1,444,920 new cases of cancer will be
diagnosed in 2007 alone. The National Institute of Health estimated that the
overall cost of cancer is $206.3 billion in 2006. This cost includes $78.2
billion in direct medical expenses, $17.9 billion in indirect morbidity costs,
and $110.2 billion in indirect mortality costs. In 2007, 559,650 Americans
are
expected to die from cancer, or one in four deaths in the United States. For
all
types of cancer diagnosed between 1996 and 2002 combined, the 5-year relative
survival rate is 66%.
Cancer
is
the second leading cause of death in America, exceeded only by heart disease.
In
the U.S., half of all men and one third of all women will develop cancer at
some
point in their lives. Since 1990, over 17 million new cancer cases have been
diagnosed. A number of drugs are used in the treatment of cancer. These drugs
are used to reduce pain, prolong the life of the patient, send the cancer into
remission or eliminate the cancer completely. We believe there is great
opportunity for improvement in all types of cancer treatment. Recognizing this
vast health and commercial opportunity, we acquire, develop, and commercialize
innovative products for the treatment of important unmet medical needs in cancer
and immunological diseases.
VQD-001
- Sodium Stibogluconate (SSG)
VQD-001
is a pentavalent antimonial drug that has been in use for over 50 years in
parts
of Africa and Asia for the treatment of leishmaniasis (a protozoan disease).
According to 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 leishmaniasis is prevalent. In collaboration with the U.S. Army, we are
pursuing development of VQD-001 in the treatment of leishmaniasis and anticipate
filing a new drug application, or NDA, with the U.S. Food and Drug
Administration, or FDA, in the second half of 2007. In December 2006, VQD-001
received orphan drug designation by the FDA for the treatment of leishmaniasis.
In
addition to treatment for leishmaniasis, several preclinical studies, especially
those conducted at the Cleveland Clinic, have showed that VQD-001 is an
inhibitor of multiple protein tyrosine phosphatases (PTPases), specifically
the
SRC homology PTPase (SHP-1 & SHP-2) and PTB-1B. 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, or cell death,
of cancerous tumors. 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.
It
is well known that one major mechanism of regulating the proliferation, growth
and apoptosis of cancer cells involves activation of cellular pathways,
especially protein tyrosine kinase pathways; the Jak/Stat pathway is a
particularly important protein tyrosine kinase pathway. It is also known that
interferon and other cytokines exert their anti-cancer effects via the Jak/Stat
pathway. We filed with the FDA an IND for VQD-001, which the FDA accepted in
August 2006, allowing us to commence clinical trials of VQD-001. 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 M.D. Anderson Cancer Center in patients with advanced malignancies
and
solid tumors that have been non-responsive in previous cytokine
therapy.
Preclinical
Data
VQD-001
has been shown to have anti-proliferative activity against a broad number of
tumor cell lines, including melanoma and renal cell lines. Pre-clinical work
in
nude mice with cancer xenografts has shown that VQD-001 can control malignancies
in vivo as well. These effects were seen whether used as part of a combination
therapy with existing treatments, including interferon and interleukin-2 or
alone. In addition, preclinical data also suggests that monotherapy with VQD-001
may be useful to treat certain other tumor types, including prostate cancer.
The
preclinical data suggests that VQD-001 utilizes multiple modes of action,
including having a direct effect on cancer cells, as well as generally enhancing
the body’s immune system. These multiple modes of action, along with VQD-001’s
known historical toxicity profile, indicate to us that VQD-001 is a potentially
attractive drug candidate to evaluate as an anti-cancer agent.
Potential
Lead Indication of VQD-001
The
standard of care for solid tumors, lymphoma, myeloma and certain other
hematological malignancies, includes either chemotherapy and/or biologic
therapy. Biologic treatment with Interferon alpha-2b, or IFN a-2b,
has
been moderately successful in controlling some of these malignancies. However,
some tumors become refractory to treatment with IFN a-2b
and
the cancer continues to grow despite continued treatment. In addition, the
toxicity profile of IFN a-2b
often
limits its clinical efficacy. We believe that the effectiveness of this existing
treatment may be improved by using VQD-001 in combination with IFN a-2b.
Specifically, we believe that VQD-001, due to its demonstrated ability to
inhibit PTPases, will augment the anti-proliferative activity and improve the
efficacy of IFN a-2b.
Therefore, we believe that the efficacy of VQD-001 in combination with IFN
a-2b
as
shown in preclinical studies together with its known historically acceptable
safety profile, may position it well as an effective combination therapy to
treat solid tumors and certain other hematological malignancies.
Clinical
Development
VQD-001
is currently being studied at M.D. Anderson Cancer Center in a Phase I/IIa
corporate-sponsored clinical trial in combination with IFN a-2b
in up
to 54-patients with advance malignancies and solid tumors that have been
non-responsive in previous cytokine therapy. We expect the M.D. Anderson Phase
I
clinical trial will be completed by the first half of 2007. Pending a successful
completion of our Phase I/IIa corporate-sponsored clinical trial, we anticipate
initiating a Phase IIb trial in the second half of 2007. The Phase IIb trial
will be designed to provide information concerning efficacy, among other
information. Prior to initiating the Phase IIb trial, we will need to apply
for
approval with the local institutional review board and identify the principal
investigator to conduct the study. There may potentially be delays in receiving
this approval, such as unforeseen safety issues and dosing issues.
VQD-001
is also being studied at the Cleveland Clinic Taussig Cancer Center in an
investigator-sponsored Phase I clinical trial in combination with IFN
a-2b
in
the treatment of refractory solid tumors, lymphoma and melanoma in up to 24
patients. We expect the Cleveland Clinic Phase I clinical trial to be completed
during the second half of 2007. Although it has no obligation to us to do so,
the Cleveland Clinic intends to fund all costs associated with this clinical
trial. In order to ensure this trial is completed, however, we may in the future
agree to fund portions of this study. Further, if the Cleveland Clinic
determines to discontinue the trials, we intend to continue product testing
at
an alternative facility such as a medical center or university to run our
clinical trials.
The
primary objectives of both the M.D. Anderson Phase I/IIa and Cleveland Clinic
Phase I clinical trials are to evaluate the tolerance, safety and maximum
tolerated dose, of VQD-001 in combination with IFN a-2b.
In
addition, these trials will also evaluate pharmacokinetic data and
anti-neoplastic activity (although the trial is not designed to evaluate
efficacy). We also hope to gain a better understanding of how VQD-001 affects
important biological and genetic pathways.
Advantages
Over Existing Developmental Therapeutics
Potential
advantages of VQD-001 over existing therapies include VQD-001’s long history of
use, acceptable toxicity, known safety profiles, and efficacy in preclinical
cancer models. As previously discussed, VQD-001 has been utilized in the
treatment of leishmaniasis for over fifty years in parts of Africa and Asia.
In
connection with such use, VQD-001 has demonstrated favorable toxicity and side
effect profiles, at dosages well in excess of the dosages we intend to utilize
in our clinical trials in the treatment of cancer. Also, based on preclinical
in
vivo
cancer
models, we believe that VQD-001 may have better efficacy in treating refractory
cancer than existing standards of care.
Competition
To
our
knowledge, no inhibitors of such PTPases have previously been demonstrated
to be
effective to treat cancer. CombinatoRx, Incorporated, a privately held
biotechnology company, is developing a clinical drug candidate containing
Pentamidine + Thorazine. Pentamidine may also be a PTPase inhibitor and has
also
previously been used for the treatment of leishmaniasis. Hoffman-La Roche Inc.
and Wyeth are investigating PTPase inhibitors for the potential treatment of
non-insulin dependent diabetes.
Additional
Potential Indication of VQD-001
As
we
continue to develop VQD-001 for indications primarily used for an oncology
therapeutic, we are also in the process of developing a treatment for
leishmaniasis which is a parasitic disease as described above. According to
the
World Health Organization, leishmaniasis currently threatens 350 million men,
women and children in 88 countries around the world. The leishmaniases are
parasitic diseases with a wide range of clinical symptoms:
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Cutaneous
leishmaniasis -
Cutaneous forms of the disease normally produce skin ulcers on the
exposed
parts of the body such as the face, arms and legs). The disease can
produce a large number of lesions - sometimes up to 200 - causing
serious
disability, and invariably leaving the patient permanently scarred,
a
stigma which can cause serious social prejudice;
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Mucocutaneous
- in mucocutaneous
forms of leishmaniasis, lesions can lead to partial or total destruction
of the mucous membranes of the nose, mouth and throat cavities
and
surrounding tissues. These disabling and degrading forms of leishmaniasis
can result in victims being humiliated and cast out from society;
and
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Visceral
leishmaniasis
- also known as kala azar - is characterized by irregular bouts of
fever,
substantial weight loss, swelling of the spleen and liver, and anaemia
(occasionally serious). If left untreated, the fatality rate in developing
countries can be as high as 100% within 2 years.
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In
collaboration with the U.S. Army, we are pursuing the development of VQD-001
in
the treatment of leishmaniasis and intend to file an NDA, with the FDA in the
second half of 2007. VQD-001 was granted orphan drug designation by the FDA
in
December 2006 for the treatment of leishmaniasis.
VQD-002
- Triciribine-Phosphate (TCN-P)
VQD-002,
a nucleoside analog, was previously advanced into clinical trials by the
National Cancer Institute in the 1980s and early 1990s, and 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. We filed with the FDA an IND relating to
VQD-002, which was accepted in April 2006. Pursuant to this IND, 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
M.D.
Anderson Cancer Center in hematological tumors, with particular attention in
leukemia.
Preclinical
Data
Recent
preclinical research performed at the Moffitt Cancer Center at the University
of
South Florida confirmed bio-activity of VQD-002 in tumor cell lines that
over-express Akt. Furthermore, in vivo studies showed that low doses of VQD-002
inhibited tumor growth in murine human xenograft models only if the xenograft
over-expressed Akt and if not Akt was over-expressed. In both human tumor cell
lines and in murine xenograft models, VQD-002 inhibited tumor cell growth and
promoted tumor cell death, a process known as apoptosis.
Potential
Lead Indication of VQD-002
The
efficacy of VQD-002 as an anti-cancer drug in previous clinical trials was
observed and toxicity was does dependent. We believe side effects were closely
related to the high dosage levels used in these trials. In addition, we believe
that the hyperglycemia seen as a side effect may have resulted from VQD-002’s
mechanism of action on Akt, as recent preclinical studies have shown that a
deficiency of Akt impairs the ability of insulin to lower blood glucose, which
could lead to a hyperglycemic condition. The previous NCI-sponsored clinical
trials used dosages that ranged up to 256mg/m2, and these trials targeted tumors
without regard to whether such tumors overexpressed Akt, since, at the time
of
such trials, the mechanism of action for VQD-002 was not fully understood.
We
believe that, based on the preclinical studies conducted to date, VQD-002
effectively and selectively induces apoptosis and inhibits growth in tumor
cells
with elevated levels of Akt at doses lower than those used in the previous
clinical trials. Therefore, we believe that by selectively screening and
treating only those patients with tumors that exhibit abnormal levels of
phosphorylated Akt, VQD-002 in low doses may achieve tumor inhibition and
regression without the significant side effects previously associated with
its
usage at higher dose levels. Our initial potential lead indication for VQD-002
will be for the treatment of solid tumors known to have abnormal levels of
phosphorylated Akt, which constitute a significant percentage of all colorectal,
ovarian, pancreatic and breast cancers.
Additional
Potential Indications for VQD-002
While
VQD-002 continues in clinical development for solid tumors that overexpress
abnormal levels of phosphorylated Akt, we have initiated two Phase I/IIa
clinical trials to explore VQD-002’s potential in the treatment for
hematological and other hematologic tumors, including leukemia. We also intend
to continue to explore other potential oncology indications by conducting
xenograph preclinical studies in various tumor models.
Clinical
Development
VQD-002
is currently being studied under our Phase I/IIa clinical trial at the Moffitt
Cancer Center at the University of South Florida in up to 42 patients in the
treatment of metastatic and refractory solid tumors including: colorectal,
pancreatic, breast and ovarian tumors. In addition we have entered into Phase
I/IIa clinical trials in up to 40 patients with advanced hematologic
malignancies at each MD Anderson Cancer Center and the Moffitt Cancer Center.
We
expect that each patient enrolled in the clinical trials will have either
refractory solid or hematologic tumors that have demonstrated abnormal levels
of
phosphorylated Akt on biopsied tumor samples. The primary objective of this
clinical trial will be to confirm the tolerance, safety and maximum tolerated
dose, of VQD-002. In addition, the trial will also provide pharmacokinetic
data
and may provide possible very early evidence of anti-neoplastic activity
(although the trial is not designed to assess efficacy) and a better
understanding of how VQD-002 impacts on levels of Akt in previously
overexpressing tumors. Pending the successful completion of these Phase I
clinical trials we expect to be completed by the first half of 2007, we
anticipate initiating Phase IIb clinical trials in the second half of 2007.
Prior to a initiating these Phase IIb clinical trials, we will need to apply
for
approval with the Institutional Review Board and the principal investigator
to
conduct the study. There may potentially be delays in receiving this approval
such as unforeseen safety issues and dosing issues.
Advantages
over Existing Developmental Therapeutics
The
planned clinical trials utilizing VQD-002 in patients that have tumors that
exhibit abnormal levels of phosphorylated Akt is a strategy that we believe
offers significant advantages over classic anticancer therapies. Our research
indicates to us that low dose treatment with VQD-002 inhibits the activation
of
Akt. This will target cancer cells specifically, while sparing healthy cells,
resulting in fewer side effects. This “targeted therapy” takes advantage of the
biologic differences between cancer cells and healthy cells. We expect this
approach to result in a decreased number of patients required to see a clinical
effect, as we predict that a larger percentage of the patients treated will
benefit from treatment with VQD-002. We expect that this will decrease both
the
clinical trial regulatory time period, and also the costs associated with such
clinical trials, as compared to traditional anticancer products currently in
clinical development.
Competition
There
is
currently no approved Akt inhibitor on the market. Keryx Biopharmaceuticals,
Inc. is developing perifosine. Perifosine is an alkylphospholipid that has
been
shown to inhibit the PI3K/Akt pathway, but research to date has not demonstrated
that it directly binds the Akt molecule. Multiple pharmaceutical companies
have
Akt inhibitors in the early discovery stage of development, including Abbott
Laboratories, Astrazeneca, Bristol-Meyers Squibb, Merck & Co., Inc. and Eli
Lilly.
To
date,
we have not received approval for the sale of any drug candidates in any market
and, therefore, have not generated any revenues from our drug candidates. The
successful development of our product candidates is highly uncertain. Product
development costs and timelines can vary significantly for each product
candidate and are difficult to accurately predict. Various laws and regulations
also govern or influence the manufacturing, safety, labeling, storage, record
keeping and marketing of each product. The lengthy process of seeking these
approvals, and the subsequent compliance with applicable statutes and
regulations, require the expenditure of substantial resources. Any failure
by us
to obtain, or any delay in obtaining, regulatory approvals could materially
adversely affect our business.
Developing
pharmaceutical products is a lengthy and very expensive process. Assuming we
do
not encounter any unforeseen safety issues during the course of developing
our
product candidates, we do not expect to complete the development of a product
candidate until late 2007 for the treatment of leishmaniasis, and 2011 for
oncology indications of VQD-001 and VQD-002, if ever. In addition, as we
continue the development of our product candidates, our research and development
expenses will further increase. To the extent we are successful in acquiring
additional product candidates for our development pipeline, our need to finance
further research and development will continue increasing. Accordingly, our
success depends not only on the safety and efficacy of our product candidates,
but also on our ability to finance the development of these product candidates.
Our major sources of working capital have been proceeds from various private
financings, primarily private sales of our common stock and other equity
securities.
Research
and development expenses consist primarily of salaries and related personnel
costs, fees paid to consultants and outside service providers for laboratory
development, legal expenses resulting from intellectual property protection,
business development and organizational affairs and other expenses relating
to
the acquiring, design, development, testing, and enhancement of our product
candidates, including milestone payments for licensed technology. We expense
our
research and development costs as they are incurred.
Government
Regulation
The
research, development, testing, manufacturing, labeling, promotion, advertising,
distribution, and marketing, among other things, of our products are extensively
regulated by governmental authorities in the U.S. and other countries. In the
United States, the FDA regulates drugs under the Federal Food, Drug, and
Cosmetic Act, or the FDCA, and its implementing regulations. Failure to comply
with the applicable U.S. requirements may subject us to administrative or
judicial sanctions, such as FDA refusal to approve pending NDAs, warning
letters, product recalls, product seizures, total or partial suspension of
production or distribution, injunctions, and/or criminal prosecution.
Drug
Approval Process
None
of
our drug candidates may be marketed in the U.S. until the drug has received
FDA
approval. The steps required before a drug may be marketed in the U.S. include:
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preclinical
laboratory tests, animal studies, and formulation
studies,
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submission
to the FDA of an IND for human clinical testing, which must become
effective before human clinical trials may
begin,
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adequate
and well-controlled human clinical trials to establish the safety
and
efficacy of the drug for each
indication,
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submission
to the FDA of an NDA,
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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
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FDA
review and approval of the NDA.
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Preclinical
tests include laboratory evaluation of product chemistry, toxicity, and
formulation, as well as animal studies. The conduct of the preclinical tests
and
formulation of the compounds for testing must comply with federal regulations
and requirements. The results of the preclinical tests, together with
manufacturing information and analytical data, are submitted to the FDA as
part
of an IND, which must become effective before human clinical trials may begin.
An IND will automatically become effective 30 days after receipt by the FDA,
unless before that time the FDA raises concerns or questions about issues such
as the conduct of the trials as outlined in the IND. In such a case, the IND
sponsor and the FDA must resolve any outstanding FDA concerns or questions
before clinical trials can proceed. We cannot be sure that submission of an
IND
will result in the FDA allowing clinical trials to begin.
Clinical
trials involve the administration of the investigational drug to human subjects
under the supervision of qualified investigators. Clinical trials are conducted
under protocols detailing the objectives of the study, the parameters to be
used
in monitoring safety, and the effectiveness criteria to be evaluated. Each
protocol must be submitted to the FDA as part of the IND.
Clinical
trials typically are conducted in three sequential phases, but the phases may
overlap. The study protocol and informed consent information for study subjects
in clinical trials must also be approved by an Institutional Review Board for
each institution where the trials will be conducted. Study subjects must sign
an
informed consent form before participating in a clinical trial. Phase I usually
involves the initial introduction of the investigational drug into people to
evaluate its short-term safety, dosage tolerance, metabolism, pharmacokinetics
and pharmacologic actions, and, if possible, to gain an early indication of
its
effectiveness. Phase II usually involves trials in a limited patient population
to (i) evaluate dosage tolerance and appropriate dosage; (ii) identify possible
adverse effects and safety risks; and (iii) evaluate preliminarily the efficacy
of the drug for specific indications. Phase III trials usually further evaluate
clinical efficacy and test further for safety by using the drug in its final
form in an expanded patient population. There can be no assurance that Phase
I,
Phase II, or Phase III testing will be completed successfully within any
specified period of time, if at all. Furthermore, the Company or the FDA may
suspend clinical trials at any time on various grounds, including a finding
that
the subjects or patients are being exposed to an unacceptable health risk.
The
FDCA
permits FDA and the IND sponsor to agree in writing on the design and size
of
clinical studies intended to form the primary basis of an effectiveness claim
in
an NDA application. This process is known as Special Protocol Assessment, or
SPA. These agreements may not be changed after the clinical studies begin,
except in limited circumstances.
Assuming
successful completion of the required clinical testing, the results of the
preclinical studies and of the clinical studies, together with other detailed
information, including information on the manufacture and composition of the
drug, are submitted to the FDA in the form of an NDA requesting approval to
market the product for one or more indications. The testing and approval process
requires substantial time, effort, and financial resources. The agencies review
the application and may deem it to be inadequate to support the registration
and
we cannot be sure that any approval will be granted on a timely basis, if at
all. The FDA may also refer the application to the appropriate advisory
committee, typically a panel of clinicians, for review, evaluation and a
recommendation as to whether the application should be approved. The FDA is
not
bound by the recommendations of the advisory committee.
The
FDA
has various programs, including fast track, priority review, and accelerated
approval, that are intended to expedite or simplify the process for reviewing
drugs, and/or provide for approval on the basis surrogate endpoints. Generally,
drugs that may be eligible for one or more of these programs are those for
serious or life-threatening conditions, those with the potential to address
unmet medical needs, and those that provide meaningful benefit over existing
treatments. We cannot be sure that any of our drug candidates will qualify
for
any of these programs, or that, if a drug candidate does qualify, that the
review time will be reduced.
Section
505b2 of the FDCA allows the FDA to approve a follow-on drug on the basis of
data in the scientific literature or data used by FDA in the approval of other
drugs. This procedure potentially makes it easier for generic drug manufacturers
to obtain rapid approval of new forms of drugs based on proprietary data of
the
original drug manufacturer.
Before
approving an NDA, the FDA usually will inspect the facility or the facilities
at
which the drug is manufactured, and will not approve the product unless cGMP
compliance is satisfactory. If the FDA evaluates the NDA and the manufacturing
facilities as acceptable, the FDA may issue an approval letter, or in some
cases, an approvable letter followed by an approval letter. Both letters usually
contain a number of conditions that must be met in order to secure final
approval of the NDA. When and if those conditions have been met to the FDA’s
satisfaction, the FDA will issue an approval letter. The approval letter
authorizes commercial marketing of the drug for specific indications. As a
condition of NDA approval, the FDA may require post marketing testing and
surveillance to monitor the drug’s safety or efficacy, or impose other
conditions.
After
approval, certain changes to the approved product, such as adding new
indications, making certain manufacturing changes, or making certain additional
labeling claims, are subject to further FDA review and approval. Before we
can
market our product candidates for additional indications, we must obtain
additional approvals from FDA. Obtaining approval for a new indication generally
requires that additional clinical studies be conducted. We cannot be sure that
any additional approval for new indications for any product candidate will
be
approved on a timely basis, or at all.
Post-Approval
Requirements
Often
times, even after a drug has been approved by the FDA for sale, the FDA may
require that certain post-approval requirements be satisfied, including the
conduct of additional clinical studies. If such post-approval conditions are
not
satisfied, the FDA may withdraw its approval of the drug. In addition, holders
of an approved NDA are required to: (i) report certain adverse reactions to
the
FDA, (ii) comply with certain requirements concerning advertising and
promotional labeling for their products, and (iii) continue to have quality
control and manufacturing procedures conform to cGMP after approval. The FDA
periodically inspects the sponsor’s records related to safety reporting and/or
manufacturing facilities; this latter effort includes assessment of compliance
with cGMP. Accordingly, manufacturers must continue to expend time, money,
and
effort in the area of production and quality control to maintain cGMP
compliance. We intend to use third party manufacturers to produce our products
in clinical and commercial quantities, and future FDA inspections may identify
compliance issues at the facilities of our contract manufacturers that may
disrupt production or distribution, or require substantial resources to correct.
In addition, discovery of problems with a product after approval may result
in
restrictions on a product, manufacturer, or holder of an approved NDA, including
withdrawal of the product from the market.
Orphan
Drug
The
FDA
may grant orphan drug designation to drugs intended to treat a “rare disease or
condition,” which generally is a disease or condition that affects fewer than
200,000 individuals in the United States. Orphan drug designation must be
requested before submitting an NDA. If the FDA grants orphan drug designation,
which it may not, the identity of the therapeutic agent and its potential orphan
use are publicly disclosed by the FDA. Orphan drug designation does not convey
an advantage in, or shorten the duration of, the review and approval process.
If
a product which has an orphan drug designation subsequently receives the first
FDA approval for the indication for which it has such designation, the product
is entitled to orphan exclusivity, meaning that the FDA may not approve any
other applications to market the same drug for the same indication, except
in
certain very limited circumstances, for a period of seven years. Orphan drug
designation does not prevent competitors from developing or marketing different
drugs for that indication. Our product candidate VQD-001 received orphan drug
designation for the treatment of leishmaniasis in December 2006.
Non-United
States Regulation
Before
our products can be marketed outside of the U.S., they are subject to regulatory
approval similar to that required in the U.S., although the requirements
governing the conduct of clinical trials, including additional clinical trials
that may be required, product licensing, pricing and reimbursement vary widely
from country to country. No action can be taken to market any product in a
country until an appropriate application has been approved by the regulatory
authorities in that country. The current approval process varies from country
to
country, and the time spent in gaining approval varies from that required for
FDA approval. In certain countries, the sales price of a product must also
be
approved. The pricing review period often begins after market approval is
granted. Even if a product is approved by a regulatory authority, satisfactory
prices may not be approved for such product.
In
Europe, marketing authorizations may be submitted at a centralized, a
decentralized or national level. The centralized procedure is mandatory for
the
approval of biotechnology products and provides for the grant of a single
marketing authorization that is valid in all EU members’ states.
As of January 1995, a mutual recognition procedure is available at the request
of the applicant for all medicinal products that are not subject to the
centralized procedure. There can be no assurance that the chosen regulatory
strategy will secure regulatory approvals on a timely basis or at
all.
Intellectual
Property and License Agreements
License
with The Cleveland Clinic Foundation. We
have
an exclusive, worldwide license agreement with the Cleveland Clinic Foundation,
or CCF, for the rights to develop, manufacture, use, commercialize, lease,
sell
and/or sublicense VQD-001. We are obligated to make annual license maintenance
payments until the first commercial sale of VQD-001, at which time we are no
longer obligated to pay this maintenance fee. In addition, the license agreement
requires us to make payments in an aggregate amount of up to $4.5 million to
CCF
upon the achievement of certain clinical and regulatory milestones. Should
VQD-001 become commercialized, we will be obligated to pay CCF an annual royalty
based on net sales of the product. In the event that we sublicense VQD-001
to a
third party, we will be obligated to pay CCF a portion of fees and royalties
received from the sublicense. We hold the exclusive right to negotiate for
a
license on any improvements to VQD-001 and have the obligation to use all
commercially reasonable efforts to bring VQD-001 to market. We have agreed
to
prosecute and maintain the patents associated with VQD-001 or provide notice
to
CCF so that it may so elect. The license agreement may be terminated by CCF,
upon notice with an opportunity for cure, for our failure to make required
payments or its material breach, or by us, upon thirty day’s written notice.
License
with the University of South Florida Research Foundation,
Inc.
We have
an exclusive, worldwide license agreement with the University of South Florida,
or USF, for the rights to develop, manufacture, use, commercialize, lease,
sell
and/or sublicense VQD-002. Under the terms of the license agreement, we have
agreed to sponsor research involving VQD-002 annually for the term of the
license agreement. In addition, the license agreement requires us to make
payments in an aggregate amount of up to $5.8 million to USF upon the
achievement of certain clinical and regulatory milestones. Should a product
incorporating VQD-002 be commercialized, we are obligated to pay to USF an
annual royalty based on net sales of the product. In the event that we
sublicense VQD-002 to a third party, we are obligated to pay USF a portion
of
fees and royalties received from the sublicense. We hold a right of first
refusal to obtain an exclusive license on any improvements to VQD-002 and have
the obligation to use all commercially reasonable efforts to bring VQD-002
to
market. We have agreed to prosecute and maintain the patents associated with
VQD-002 or provide notice to USF so that it may so elect. The license agreement
shall automatically terminate upon our bankruptcy or upon the date of the last
to expire claim contained in the patents subject to the license agreement.
The
license agreement may be terminated by USF, upon notice with an opportunity
for
cure, for our failure to make required payments or its material breach, or
by
us, upon six month’s written notice.
Employees
and Consultants
As
of
March 9, 2007, we have fifty full-time employees. None of our employees is
represented by a collective bargaining unit. We consider our relations with
our
employees to be good.
As
we
develop our technology and business, we anticipate the need to hire additional
employees, especially employees with expertise in the areas of clinical
operations, business development, chemistry, sales and marketing.
RISK
FACTORS
Risks
Related to Our Company
We
have no meaningful operating history on which to evaluate our business or
prospects.
We
commenced operations in October 2000 through our Chiral Quest business. In
September 2006, our board of directors determined to seek strategic alternatives
for this business, including potentially selling or otherwise disposing of
it.
In August 2004, we also determined to become engaged in the drug development
business and only acquired rights to our first drug candidates in October 2005
through our acquisition of Greenwich Therapeutics. Therefore, we have only
a
limited operating history on which you can base an evaluation of our business
and prospects. Accordingly, our business prospects must be considered in light
of the risks, uncertainties, expenses and difficulties frequently encountered
by
companies in their early stages of development, particularly companies in new
and rapidly evolving markets, such as drug development, fine chemical,
pharmaceutical and biotechnology markets.
Our
management anticipates incurring losses for the foreseeable future.
For
the
year ended December 31, 2006, we had a net loss of $8,271,164, of which
$5,175,570 related to our continuing operations. For the year ended December
31,
2005, we had a net loss of $12,834,629, of which $10,353,884 related to our
continuing operations, and since our inception in October 2000 through December
31, 2006, we have incurred an aggregate net loss of $28,540,556. As of December
31, 2006, we had total assets of $5,828,323, of which $2,931,265 was cash or
cash equivalents. We expect operating losses to continue for the foreseeable
future and there can be no assurance that we will ever be able to operate
profitably.
We
will require additional financing in order to complete the development of our
products and services and otherwise develop our business operations. Such
financing may not be available on acceptable terms, if at all.
Following
the completion of our October 2006 private placement, we anticipate that our
current capital will be adequate to fund our operations through June 30, 2007.
However, changes may occur that would consume available capital resources before
that time. Our combined capital requirements will depend on numerous factors,
including: costs associated with our drug development process, and costs of
clinical programs, changes in our existing collaborative relationships, the
cost
of filing, prosecuting, defending and enforcing patent claims and other
intellectual property rights and the outcome of any potentially related
litigation or other dispute, acquisition of technologies, costs associated
to
the development and regulatory approval progress of our drug compounds, costs
relating to milestone payments to our licensors, license fees and manufacturing
costs, the hiring of additional people in the business development, chemistry
and administrative areas. In September 2006, our board of directors directed
our
management to explore strategic alternatives for our Chiral Quest business
operations, including the possible sale of that business, which may potentially
provide us with additional net cash proceeds. Unless we are able to sell our
Chiral Quest operation, we will require additional financing during 2007 in
order to continue operations. The most likely source of such financing includes
private placements of our equity or debt securities or bridge loans to us from
third party lenders.
Additional
capital that may be needed by us in the future may not be available on
reasonable terms, or at all. If adequate financing is not available, we may
be
required to terminate or significantly curtail our operations, or enter into
arrangements with collaborative partners or others that may require us to
relinquish rights to certain of our technologies, or potential markets that
we
would not otherwise relinquish.
Our
operating results will fluctuate, making it difficult to predict our results
of
operations in any future period.
As
we
develop our business, we expect our operating results to vary significantly
from
quarter-to-quarter. As a result, quarter-to-quarter comparisons of our operating
results may not be meaningful. In addition, due to the fact that we have little
or no significant operating history with our new technology, we cannot predict
our future revenues or results of operations accurately. Our current and future
expense levels are based largely on our planned expenditures.
A
small group of persons is able to exert significant control over us.
Our
current officers and directors beneficially own or control approximately 10%
of
our common stock. Individually and in the aggregate, these persons will have
significant influence over the management of our business, the election of
directors and all matters requiring shareholder approval. In particular, this
concentration of ownership may have the effect of facilitating, delaying,
deferring or preventing a potential acquisition of our company and may adversely
affect the market price of our common stock. Additionally, one member of
our Board of Directors is an employee of Paramount BioCapital, Inc., or one
of
its affiliates. Dr. Lindsay A. Rosenwald is the chairman and sole owner of
Paramount BioCapital, Inc. and such affiliates. Dr. Rosenwald beneficially
owns
6% of our outstanding common stock, and several trusts for the benefit of Dr.
Rosenwald and his family beneficially own 14% of our outstanding common stock.
Although Dr. Rosenwald does not have the legal authority to exercise voting
power or investment discretion over the shares held by those trusts, he
nevertheless may have the ability to exert significant influence over the
Company.
Risks
Related to Our Drug Development Business
From
the rights to we have obtained to develop and commercialize our drug candidates,
we will require significant additional financing, which may not be available
on
acceptable terms and will significantly dilute your ownership of our common
stock.
We
will
not only require additional financing to develop and bring the drug to market.
Our future capital requirements will depend on numerous factors, including:
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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;
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the
results of any clinical trials;
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the
scope and results of our research and development programs;
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the
time required to obtain regulatory approvals;
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our
ability to establish and maintain marketing alliances and collaborative
agreements; and
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the
cost of our internal marketing activities.
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We
will
likely look to obtain the necessary additional financing by selling shares
of
our capital stock. If adequate funds are not available, we will be required
to
delay, scale back or eliminate a future drug development program or obtain
funds
through arrangements with collaborative partners or others that may require
us
to relinquish rights to technologies or products that we would not otherwise
relinquish.
We
will continue to experience significant negative cash flow for the foreseeable
future and may never become profitable.
Because
drug development takes several years and is extremely expensive, we expect
that
our drug development subsidiary will incur substantial losses and negative
operating cash flow for the foreseeable future, and may never achieve or
maintain profitability, even if we succeed in acquiring, developing and
commercializing one or more drug candidates. In connection with our proposed
drug development business, we also expect to continue to incur significant
operating and capital expenditures and anticipate that our expenses will
increase substantially in the foreseeable future as we:
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acquire
the rights to develop and commercialize a drug candidate;
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undertake
pre-clinical development and clinical trials for drug candidates
that we
acquire;
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seek
regulatory approvals for drug candidates;
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implement
additional internal systems and infrastructure;
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lease
additional or alternative office facilities; and
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hire
additional personnel.
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Our
drug
development business may not be able to generate revenue or achieve
profitability. Our failure to achieve or maintain profitability could negatively
impact the value of our common stock.
If
we are not able to obtain the necessary U.S. or worldwide regulatory approvals
to commercialize any product candidates that we acquire, we will not be able
to
sell those products.
We
will
need FDA approval to commercialize drug candidates in the U.S. and approvals
from the FDA equivalent regulatory authorities in foreign jurisdictions to
commercialize our product candidates in those jurisdictions. In order to obtain
FDA approval of a drug candidate, we will be required to first submit to the
FDA
for approval an IND, which will set forth our plans for clinical testing of
a
particular drug candidate.
When
the
clinical testing for our product candidates is complete, we will then be
required to submit to the FDA a New Drug Application, or “NDA,” demonstrating
that the product candidate is safe for humans and effective for its intended
use. This demonstration will require significant research and animal tests,
which are referred to as pre-clinical studies, as well as human tests, which
are
referred to as clinical trials. Satisfaction of the FDA’s regulatory
requirements typically takes many years, depends upon the type, complexity
and
novelty of the product candidate and requires substantial resources for
research, development and testing. The FDA has substantial discretion in the
drug approval process and may require us to conduct additional pre-clinical
and
clinical testing or to perform post-marketing studies. The approval process
may
also be delayed by changes in government regulation, future legislation or
administrative action or changes in FDA policy that occur prior to or during
our
regulatory review. Delays in obtaining regulatory approvals may:
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delay
commercialization of, and our ability to derive product revenues
from, a
drug candidate;
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impose
costly procedures on us; and
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diminish
any competitive advantages that we may otherwise enjoy.
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Even
if
we comply with all FDA requests, the FDA may still ultimately reject an NDA.
Failure to obtain FDA approval of a drug candidate will severely undermine
our
business development by reducing our ability to recover the development costs
expended in connection with a drug candidate and realize any profit from
commercializing a drug candidate.
In
foreign jurisdictions, we will be required to obtain approval from the
appropriate regulatory authorities before we can commercialize our drugs.
Foreign regulatory approval processes generally include all of the risks
associated with the FDA approval procedures described above.
Clinical
trials are very expensive, time-consuming and difficult to design and implement.
Assuming
we are able to acquire the rights to develop and commercialize a product
candidate, we will be required to expend significant time, effort and money
to
conduct human clinical trials necessary to obtain regulatory approval of any
product candidate. Human clinical trials are very expensive and difficult to
design and implement, in part because they are subject to rigorous regulatory
requirements. The clinical trial process is also time consuming. We estimate
that clinical trials of any product candidate will take at least several years
to complete. Furthermore, failure can occur at any stage of the trials, and
we
could encounter problems that cause us to abandon or repeat clinical trials.
The
commencement and completion of clinical trials may be delayed by several
factors, including:
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unforeseen
safety issues;
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determination
of dosing issues;
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lack
of effectiveness during clinical trials;
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slower
than expected rates of patient recruitment;
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inability
to monitor patients adequately during or after treatment; and
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inability
or unwillingness of medical investigators to follow our clinical
protocols.
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In
addition, we or the FDA may suspend our clinical trials at any time if it
appears that we are exposing participants to unacceptable health risks or if
the
FDA finds deficiencies in our IND submissions or the conduct of these trials.
The
results of any clinical trial may not support the results of pre-clinical
studies relating to our product candidate, which may delay development of any
product candidate or cause us to abandon development altogether.
Even
if
any clinical trials we undertake with respect to a future product candidate
that
we acquire are completed as planned, we cannot be certain that their results
will support the findings of pre-clinical studies upon which a development
plan
would be based. Success in pre-clinical testing and early clinical trials does
not ensure that later clinical trials will be successful, and we cannot be
sure
that the results of later clinical trials will replicate the results of prior
clinical trials and pre-clinical testing. The clinical trial process may fail
to
demonstrate that our product candidates are safe for humans and effective for
indicated uses. This failure may cause us to delay the development of a product
candidate or even to abandon development altogether. Such failure may also
cause
delay in other product candidates. Any delay in, or termination of, our clinical
trials will delay the filing of our NDAs with the FDA and, ultimately, our
ability to commercialize our product candidates and generate product revenues.
If
physicians and patients do not accept and use our drugs after regulatory
approvals are obtained, we will not realize sufficient revenue from such product
to cover our development costs.
Even
if
the FDA approved any product candidate that we acquired and subsequently
developed, physicians and patients may not accept and use them. Acceptance
and
use of the product candidates we acquire (if any) will depend upon a number
of
factors including:
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perceptions
by members of the health care community, including physicians, about
the
safety and effectiveness of our drugs;
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cost-effectiveness
of our product relative to competing products;
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availability
of reimbursement for our products from government or other healthcare
payers; and
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effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any.
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Because
our drug development business plan contemplates that substantially all of any
future revenues we will realize will result from sales of product candidates
that we develop, the failure of any of drugs we acquire and develop to find
market acceptance would significantly and adversely affect our ability to
generate cash flow and become profitable.
We
intend to rely upon third-party researchers and other collaborators who will
be
outside our control and may not devote sufficient resources to our projects.
We
intend
to collaborate with third parties, such as drug investigators, researchers
and
manufacturers, in the development of any product candidate that we acquire.
Such
third parties, which might include universities and medical institutions, will
likely conduct the necessary pre-clinical and clinical trials for a product
candidate that we develop. Accordingly, our successful development of any
product candidate will likely depend on the performance of these third parties.
These collaborators will not be our employees, however, and we may be unable
to
control the amount or timing of resources that they will devote to our programs.
For example, such collaborators may not assign as great a priority to our
programs or pursue them as diligently as we would if we were undertaking such
programs ourselves. If outside collaborators fail to devote sufficient time
and
resources to our drug-development programs, or if their performance is
substandard, the approval of our FDA applications, if any, and our introduction
of new drugs, if any, will be delayed. These collaborators may also have
relationships with other commercial entities, some of whom may compete with
us
in the future. If our collaborators were to assist our competitors at our
expense, the resulting adverse impact on our competitive position could delay
the development of our drug candidates or expedite the development of a
competitor’s candidate.
We
will rely exclusively on third parties to formulate and manufacture our product
candidates.
We
do not
currently have, and have no current plans to develop, the capability to
formulate or manufacture drugs. Rather, we intend to contract with one or more
manufacturers to manufacture, supply, store and distribute drug supplies that
will be needed for any clinical trials we undertake. If we received FDA approval
for any product candidate, we would rely on one or more third-party contractors
to manufacture our drugs. Our anticipated future reliance on a limited number
of
third-party manufacturers will expose us to the following risks:
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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.
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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.
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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.
|
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.
If
we are not able to successfully compete against other drug companies, our
business will fail.
The
market for new drugs is characterized by intense competition and rapid
technological advances. If any drug candidate that we develop receives FDA
approval, we will likely compete with a number of existing and future drugs
and
therapies developed, manufactured and marketed by others. Existing or future
competing products may provide greater therapeutic convenience or clinical
or
other benefits for a specific indication than our products, or may offer
comparable performance at a lower cost or with fewer side-effects. If our
products fail to capture and maintain market share, we may not achieve
sufficient product revenues and our business will suffer.
We
will
be competing against fully integrated pharmaceutical companies and smaller
companies that are collaborating with larger pharmaceutical companies, academic
institutions, government agencies and other public and private research
organizations. Many of these competitors have drug candidates already approved
or in development. In addition, many of these competitors, either alone or
together with their collaborative partners, operate larger research and
development programs and have substantially greater financial resources than
we
do, as well as significantly greater experience in:
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developing
drugs;
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undertaking
pre-clinical testing and human clinical trials;
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obtaining
FDA and other regulatory approvals of drugs;
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formulating
and manufacturing drugs; and
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launching,
marketing and selling drugs.
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Risks
Related to Our Securities
Trading
of our common stock is limited, which may make it difficult for you to sell
your
shares at times and prices that you feel are appropriate.
Trading
of our common stock, which is conducted on the OTC Bulletin Board, has been
limited. This adversely effects the liquidity of our common stock, not only
in
terms of the number of shares that can be bought and sold at a given price,
but
also through delays in the timing of transactions and reduction in security
analysts’ and the media’s coverage of us. This may result in lower prices for
our common stock than might otherwise be obtained and could also result in
a
larger spread between the bid and asked prices for our common stock.
Because
it is a “penny stock,” it will be more difficult for you to sell shares of our
common stock.
In
addition, our common stock is considered a “penny stock” under SEC rules because
it has been trading on the OTC Bulletin Board at a price lower than $5.00.
Broker-dealers who sell penny stocks must provide purchasers of these stocks
with a standardized risk-disclosure document prepared by the SEC. This document
provides information about penny stocks and the nature and level of risks
involved in investing in the penny-stock market. A broker must also give a
purchaser, orally or in writing, bid and offer quotations and information
regarding broker and salesperson compensation, make a written determination
that
the penny stock is a suitable investment for the purchaser, and obtain the
purchaser’s written agreement to the purchase. Broker-dealers also must provide
customers that hold penny stocks in their accounts with such broker-dealer
a
monthly statement containing price and market information relating to the penny
stock. If a penny stock is sold to you in violation of the penny stock rules,
you may be able to cancel your purchase and get your money back. The penny
stock
rules may make it difficult for you to sell your shares of our stock, however,
and because of the rules, there is less trading in penny stocks. Also, many
brokers simply choose not to participate in penny-stock transactions.
Accordingly, you may not always be able to resell shares of our common stock
publicly at times and prices that you feel are appropriate.
Our
stock price is, and we expect it to remain, volatile, which could limit
investors’ ability to sell stock at a profit.
The
volatile price of our stock makes it difficult for investors to predict the
value of their investment, to sell shares at a profit at any given time, or
to
plan purchases and sales in advance. A variety of factors may affect the market
price of our common stock. These include, but are not limited to:
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announcements
of technological innovations or new commercial products by our competitors
or us;
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·
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developments
concerning proprietary rights, including patents;
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·
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regulatory
developments in the United States and foreign countries;
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·
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economic
or other crises and other external factors;
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·
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period-to-period
fluctuations in our revenues and other results of operations;
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·
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changes
in financial estimates by securities analysts; and
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·
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sales
of our common stock.
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We
will
not be able to control many of these factors, and we believe that
period-to-period comparisons of our financial results will not necessarily
be
indicative of our future performance.
In
addition, the stock market in general, and the market for biotechnology
companies in particular, has experienced extreme price and volume fluctuations
that may have been unrelated or disproportionate to the operating performance
of
individual companies. These broad market and industry factors may seriously
harm
the market price of our common stock, regardless of our operating performance.
Because
we do not expect to pay dividends, you will not realize any income from an
investment in our common stock unless and until you sell your shares at profit.
We
have
never paid dividends on our common stock and do not anticipate paying any
dividends for the foreseeable future. You should not rely on an investment
in
our stock if you require dividend income. Further, you will only realize income
on an investment in our shares in the event you sell or otherwise dispose of
your shares at a price higher than the price you paid for your shares. Such
a
gain would result only from an increase in the market price of our common stock,
which is uncertain and unpredictable.
ITEM
2. LEGAL PROCEEDINGS
We
are
not a party to any material litigation and are not aware of any threatened
litigation that would have a material adverse effect on our
business.
ITEM
3. DESCRIPTION OF PROPERTY
We
lease
office and laboratory space in Basking Ridge, New Jersey; Monmouth Junction,
New
Jersey; and in the People’s Republic of China, as summarized below:
Basking
Ridge, New Jersey.
We have
amended our original lease agreement effective June 15, 2005, for additional
office space effective November 20, 2006 for our principal executive offices
located in Basking Ridge, New Jersey. This facility consists of approximately
4,000 square feet of office space. Pursuant to the lease agreement term of
sixty-two months, we pay approximately $8,000 per month for rent and utilities.
Our total lease commitment of approximately $494,000 for rent and utilities
expires in January 2012.
Monmouth
Junction, New Jersey.
Through
our discontinued operation, Chiral Quest, we occupy approximately 9,000 square
feet of mostly laboratory space, and office space, for our Chiral Quest business
located in Monmouth Junction, New Jersey. In January 2006, we amended our
original May 2003 lease agreement to extend our lease term to May 31, 2009.
Pursuant to this amendment, effective June 1, 2006, our monthly base rent is
$19,439, in addition to monthly operating, utilities and maintenance fees of
$8,350. Upon six months prior written notice to the landlord, we will have
a one
time option, without penalty, to terminate this lease effective as of May 31,
2008. Our total lease commitment of approximately $799,000 for rent, utilities
and maintenance fees expires in May 2009.
The
People’s Republic of China. Through
our discontinued operation, Chiral Quest, pursuant
to an agreement effective December 15, 2004, with the Science and Technology
Bureau of Jiashan County (“Jiashan”) in Zhejiang Province of the People’s
Republic of China, we have agreed to lease a total of 4,000 square meters of
laboratory and office space in an industrial park near Shanghai, 50 percent
of
which we began occupying in 2005. Pursuant to our agreement with Jiashan,
although we are not required to pay rent during the initial 3-years of the
lease, we pay a maintenance fee of up to $4,500 per month, which is comprised
of
maintenance and management fees. Following the initial 3-year term, we may,
at
our sole discretion, either continue leasing the space for annual rent of no
more than $60,000 or purchase the facility on commercially reasonable terms.
We
have no financial obligation pursuant to the lease agreement after the end
of
the three year term. We were also granted the option to purchase in the next
three years approximately 33 acres of land adjacent to the industrial park.
For
purposes of entering into the lease, we established a wholly owned subsidiary
organized under the laws of Hong Kong, known as Chiral Quest Ltd., which in
turn
will be the sole shareholder of a subsidiary in the People’s Republic of China,
Chiral Quest (Jiashan) Ltd.
We
believe our existing facilities, as described above, are adequate to meet our
needs through the year ending December 31, 2007.
ITEM
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None.
PART
II
ITEM
5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Market
for Common Stock
Since
August 27, 2004 our common stock has traded on the OTC Bulletin Board under
the
symbol “VQPH.OB.” Prior to that, our common stock traded on the OTC Bulletin
Board under the symbol “CQST.OB.” The following table lists the high and low bid
price for our common stock as quoted, in U.S. dollars, by the OTC Bulletin
Board
during each quarter within the last two completed fiscal years. These quotations
reflect inter-dealer prices, without retail mark-up, markdown, or commission
and
may not represent actual transactions.
Quarter
Ended
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High
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|
Low
|
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March
31, 2005
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$
|
0.99
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$
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0.60
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|
June
30, 2005
|
|
$
|
0.70
|
|
$
|
0.70
|
|
September
30, 2005
|
|
$
|
1.15
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$
|
1.05
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|
December
31, 2005
|
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$
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0.76
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$
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0.70
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March
31, 2006
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$
|
0.85
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$
|
0.81
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June
30, 2006
|
|
$
|
0.80
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|
$
|
0.77
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September
30, 2006
|
|
$
|
0.65
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|
$
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0.60
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December
31, 2006
|
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$
|
0.53
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$
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0.43
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Record
Holders
As
of
March 19, 2007, we had approximately 1,653 holders of record of our common
stock, one of which was Cede & Co., a nominee for Depository Trust Company,
or DTC. Shares of common stock that are held by financial institutions as
nominees for beneficial owners are deposited into participant accounts at DTC,
and are considered to be held of record by Cede & Co. as one
stockholder.
Dividends
We
have
not paid or declared any dividends on our common stock and we do not anticipate
paying dividends on our common stock in the foreseeable future.
Stock
Re-Purchases
We
did
not make any re-purchases of shares of our common stock during the fourth
quarter of fiscal 2006 and we do not currently have any publicly-announced
repurchase plans in effect.
ITEM
6.
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MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OR PLAN OF OPERATIONS.
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Overview
We
operate two distinct business units, through our continuing drug development
business, we acquire, develop and intend to commercial innovative products
for
the treatment of key unmet medical needs in cancer and immunological diseases,
and through our discontinued operation’s subsidiary Chiral Quest, Inc., we sell
chiral products and services and contract research and development services.
In
December 2004, we established our Chiral Quest, Ltd. Jiashan, China facility,
and commenced research and development and manufacturing operations during
the
second half of 2005.
In
August
2004, we expanded our business plan to also focus on acquiring technologies
for
purposes of development and commercialization of pharmaceutical drug candidates
for the treatment in oncology and antiviral diseases and disorders for which
there are unmet medical needs. In accordance with this expanded business plan,
in October 2005, the Company acquired in a merger transaction Greenwich
Therapeutics, Inc., a privately-held New York-based biotechnology company that
held exclusive rights to develop and commercialize two oncology drug candidates
- VQD-001 (Sodium Stibogluconate, or also SSG) and VQD-002
(Triciribine-Phosphate, or TCN-P). Both of these drug candidates are in early
stages of development and cannot be sold until we have obtained the approval
of
the U.S. Food and Drug Administration, or FDA, or a comparable regulatory body
in foreign countries. The rights to these two oncology drug candidates, VQD-001
and VQD-002, are governed by license agreements with The Cleveland Clinic
Foundation and the University of South Florida Research Foundation,
respectively. As a result of our acquisition of Greenwich Therapeutics, the
Company holds exclusive rights to develop, manufacture, use, commercialize,
lease, sell and/or sublicense VQD-001 and VQD-002. We have initiated three
Phase
I/IIa clinical trials since acquiring the license rights to VQD-001 and
VQD-002.
On
September 29, 2006, our board of directors directed our management to seek
strategic alternatives with respect to our Chiral Quest, which may include
a
sale or other disposition of the operating assets of that business. Accordingly,
Chiral Quest’s assets, liabilities and operations are presented in these
financial statements as discontinued operations. Chiral Quest had accounted
for
all sales of the Company from its inception. Our continuing operations, which
have not generated any revenues, will focus on the remaining drug development
operations of VioQuest Pharmaceuticals, Inc., and accordingly, we are reporting
one segment. No provision has been made to reduce the carrying amounts of the
assets of the discontinued operations as we believe they approximate their
estimated net realizable values.
Since
inception, we have incurred an accumulated deficit of $28,540,556 through
December 31, 2006. For the year ended December 31, 2006 we had losses from
continuing operations of $5,175,570, and used cash in continuing operating
activities totaling $3,955,017. As
of
December 31, 2006, we had working capital of $1,442,522 and cash and cash
equivalents of $2,931,265. We
expect
our operating losses to increase over the next several years, primarily related
to our drug development and costs associated with clinical programs, milestone
payments to both the Cleveland Clinic Foundation and the University of South
Florida for the development of VQD-001 and VQD-002, respectively, in addition
to
costs related to license fees, manufacturing of our products, regulatory
approvals, and the hiring of additional people in the business development,
chemistry and administrative areas.
Management
expects our losses to increase over the next several years, due to the expansion
of our drug development business, costs associated with the clinical development
of VQD-001 and VQD-002. These matters raise substantial doubt about our ability
to continue as a going concern.
Results
of Operations - Years Ended December 31, 2006 vs. 2005
Continuing
Operations:
We
had no
revenues from our continuing operations through December 31, 2006.
In-process
research and development, or (“IPR&D”) costs for the year ended December 31,
2006 was $0 as compared to $7,975,218 for the year ended December 31, 2005.
The
charge for the year ended December 31, 2005 is attributed to the acquisition
of
Greenwich Therapeutics in October 2005. The acquisition costs were comprised
of:
$5,995,077 related to the calculated value of 8,564,395 shares of our common
stock issued to Greenwich Therapeutics’ shareholders valued at $0.70 per share
($0.70 per share value was based upon the average stock price of our common
stock a few days before and a few days subsequent to the July 7, 2005 definitive
merger agreement announcement), $986,039 related to the calculated value of
2,000,000 warrants issued to Greenwich Therapeutics’ shareholders using the
Black-Scholes stock option pricing model, $823,869 related to debt we
assumed as part of the merger of Greenwich Therapeutics and $170,234 is
comprised of license fees, legal fees and other professional fees incurred
as
part of the merger with Greenwich Therapeutics.
Research
and development, or (“R&D”), expenses for the year ended December 31, 2006
were $1,819,736 as compared to $0 for the year ended December 31, 2005. R&D
is attributed to clinical development costs, milestone license fees, maintenance
fees provided to the institutions we licensed VQD-001 and VQD-002, outside
manufacturing costs, outside clinical research organization costs, in addition
to regulatory and patent filing costs associated to our two oncology compounds
VQD-001 and VQD-002 currently in clinical trials. The increase in R&D for
the year ended December 31, 2006, is a result of having no R&D costs from
our two oncology compounds for the year ended December 31, 2005 as a result
of
acquiring them in October 2005, and initiating our clinical studies in 2006.
Additionally, R&D charges for the year ended December 31, 2006 consist of
milestone license fees incurred in connection with receiving acceptance of
our
Investigational New Drug Application filing for VQD-002 in April 2006 of
$100,000, maintenance fees provided to the institutions we licensed VQD-001
and
VQD-002 from of approximately $25,000 and $35,000 respectively, outside
regulatory and legal fees of $445,000, employee costs of $440,000, outside
clinical research organization costs of $452,000 and outside manufacturing
costs
of approximately $245,000. We expect R&D spending related to our existing
product candidates to continue to increase over the next several years as we
expand our clinical trials.
Selling,
general and administrative, or (“SG&A”), expenses for the year ended
December 31, 2006 were $3,455,225 as compared to $2,419,442 during the year
ended December 31, 2005. This increase in SG&A expenses was due in part to
the impact of expensing employee and director stock options beginning with
the
year ended December 31, 2006 in accordance with SFAS No. 123R of approximately
$830,000, additional spending on conferences, increased travel expenses for
new
business development opportunities and higher administrative expenses associated
with having more employees which include the Chief Medical Officer hired in
March 2006, the Vice President of Regulatory and Clinical Operations hired
in
October 2006, in addition to other related employee costs such as increased
insurance, and employer payroll taxes and increased rent expense for the newly
extended leased corporate headquarters facility in Basking Ridge, New Jersey.
Additionally, management and consulting expenses contributed to part of the
SG&A increase, which was primarily attributed to a consultancy agreement for
the strategic and technical assessment of our clinical development programs
that
we entered in with Paramount Corporate Development, an affiliate of Paramount
BioCapital, Inc., a related party. The consultancy agreement was for a total
of
$90,000, for a period of three months for $30,000 per month commencing in August
2006.
Depreciation
expense for the year ended December 31, 2006 was $6,304 as compared to $1,646
for the year ended December 31, 2005. The increase in depreciation expense
is a
result of the additional purchases of computer and office equipment for
additional employees and our office expansion during 2006, for our office in
Basking Ridge, respectively.
Interest
income, net of interest expense for the year ended December 31, 2006 was
$105,695 as compared to $42,422 for the year ended December 31, 2005. Interest
income received during the year ended December 31, 2006 was approximately
$122,000, which was offset by interest expense of approximately $16,000, for
the
repayment of the final one third amount of debt owed, of approximately $264,000,
to Paramount BioCapital, which was assumed as part of the October 2005
acquisition of Greenwich Therapeutics. The increase in interest income for
the
year ended December 31, 2006 is attributed to having a higher cash balance
throughout 2006 as a result of the October 2005 and October 2006
financings.
Our
loss
from continuing operations for the year ended December 31, 2006 was $5,175,570
as compared to $10,353,884 for the year ended December 31, 2005. The decreased
loss from continuing operations for the year ended December 31, 2006 as compared
to the year ended December 31, 2005, was primarily due to the IPR&D charges
related to the acquisition of Greenwich Therapeutics in October 2005 for
$7,975,218, offset by the impact of expensing employee and director stock
options beginning with the year ended December 31, 2006 of approximately
$830,000 in accordance with SFAS No. 123R, additional spending on conferences,
increased travel expenses for new business development opportunities and higher
administrative expenses associated with having more employees which include
the
Chief Medical Officer hired in March 2006, the Vice President of Regulatory
and
Clinical Operations hired in October 2006, in addition to other related employee
costs such as increased insurance, and employer payroll taxes and increased
rent
expense for the newly leased corporate headquarter facility in Basking Ridge,
New Jersey. Increased R&D expenses also contributed to the loss from
continuing operations for the year ended December 31, 2006 as compared to having
no R&D expenses related to our drug development business for the year ended
December 31, 2005. R&D expenses related to our drug development business
include clinical research organization and manufacturing costs, maintenance
and
licensing fees provided to the institutions we licensed VQD-001 and VQD-002
from, in addition to other clinical development costs for the VQD-001 and
VQD-002 clinical programs. We expect losses to continue to increase for the
next
several years from the costs associated with the drug development process
related to developing our drug candidates.
Discontinued
Operations:
Our
loss
from discontinued operations for the year ended December 31, 2006 was $3,095,594
as compared to $2,480,745 for the year ended December 31, 2005. The increased
loss from discontinued operations for the year ended December 31, 2006 as
compared to December 31, 2005 was primarily attributable a decrease in revenues
from the prior year of approximately $1.1 million, establishing inventory
reserves for slow moving materials of approximately $427,000, and the expensing
of employee stock options of approximately $210,000, offset by having lower
overhead expenses resulting from a reduced number of employees located in our
New Jersey facility, lower R&D expenditures as a result of focusing on
commercializing our proprietary technology.
Results
of Operations - Years Ended December 31, 2005 vs. 2004
Continuing
Operations:
We
had no
revenues from our continuing operations through December 31, 2005.
IPR&D
costs of $7,975,218 for the year ended December 31, 2005 are attributed to
the
acquisition of Greenwich Therapeutics, Inc. in October 2005. The acquisition
costs are comprised of: $5,995,077 related to the calculated value of 8,564,395
shares of the Company’s common stock issued to Greenwich Therapeutics’
shareholders valued at $0.70 per share ($0.70 per share value was based upon
the
average stock price of our common stock a few days before and a few days
subsequent to the July 7, 2005 definitive merger agreement announcement),
$986,039 related to the calculated value of 2,000,000 warrants issued to
Greenwich Therapeutics’ shareholders using the Black-Scholes stock option
pricing model, $823,869 related to debt we assumed as part of the merger of
Greenwich Therapeutics and $170,234 is comprised of license fees, legal fees
and
other professional fees incurred as part of the merger with Greenwich
Therapeutics.
SG&A
expenses for the year ended December 31, 2005 were $2,419,442 as compared to
$0
for the year ended December 31, 2004. This increase in SG&A expenses was
primarily due to having no drug development business expenses until 2005. As
part of our drug development expansion, we hired our president and CEO in
February 2005, and hired our Vice President of Corporate Business Development
in
July 2005. SG&A also increased as a result of increased spending on
conferences, increased travel expenses for new business development
opportunities and higher administrative expenses associated with employee costs
such as increased insurance, and employer payroll taxes and increased rent
expense for the newly leased corporate headquarters facility in Basking Ridge,
New Jersey in September 2005. Additionally, management
and consulting expenses contributed $263,534 as part of the SG&A increase,
which was primarily attributed to a non-recurring
charge of $190,000 from the issuance of 200,000 shares of our common stock
to an
outside consultant in the third quarter 2005, in addition to the Company
utilizing regulatory and advisory consultants in the due diligence process
of
acquiring our two oncology compounds, VQD-001 and VQD-002 in October 2005.
Interest
income, net of interest expense for the year ended December 31, 2005 was $42,422
as compared to $0 for the year ended December 31, 2004. The increase was
attributed to having higher cash balances during the year ended December 31,
2005 as compared to 2004 as a result of completing a financing in October 2005
for approximately $8.4 million.
Our
loss
from continuing operations for the year ended December 31, 2005 was $10,353,884
as compared to $0 for the year ended December 31, 2004. The increased loss
from
continuing operations for the year ended December 31, 2005 as compared to
December 31, 2004 was primarily due to having no drug development business
expenses until 2005. In October 2005, we acquired Greenwich Therapeutics and
incurred IPR&D expenses of approximately $7.9 million as a result of the
Company acquiring two oncology compounds through the acquisition of Greenwich
Therapeutics, Inc. in October 2005 for $7,975,218, in addition to higher
SG&A expenses due in part to having more employees which include the
President and CEO hired in February 2005, the Vice President of Corporate
Business Development hired in July 2005, additional spending on conferences,
increased travel expenses for new business development opportunities and higher
administrative expenses associated with other related employee costs such as
increased insurance, and employer payroll taxes and increased rent expense
for
the newly leased corporate headquarters facility in Basking Ridge, New Jersey
in
September 2005.
Discontinued
Operations:
Our
loss
from discontinued operations for the year ended December 31, 2005 was $2,480,745
as compared to $4,023,558 for the year ended December 31, 2004. The decreased
loss from discontinued operations for the year ended December 31, 2005, as
compared to December 31, 2004 was primarily attributable to increased gross
profits as a result of having higher revenues in 2005 versus 2004, in addition
to having lower overhead expenses resulting from a reduced number of employees
located in our New Jersey facility, lower R&D expenditures as a result of
focusing on commercializing our proprietary technology, in addition to receiving
a tax benefit of approximately $236,000 from the State of New Jersey, from
the
sale of our net operating losses.
Liquidity
and Capital Resources:
In
August
2004, we decided to focus on acquiring technologies for
purposes
of development and commercialization of pharmaceutical drug candidates for
the
treatment of oncology and antiviral diseases and disorders for which there
are
unmet medical needs. In accordance with this business plan, in October 2005,
we
acquired in a merger transaction Greenwich Therapeutics, Inc., a privately-held
New York-based biotechnology company that held exclusive rights to develop
and
commercialize two oncology drug candidates - VQD-001, and VQD-002. The rights
to
these two oncology drug candidates, VQD-001 and VQD-002, are governed by license
agreements with The Cleveland Clinic Foundation and the University of South
Florida Research Foundation, respectively. As a result of our acquisition of
Greenwich Therapeutics, we hold exclusive rights to develop, manufacture, use,
commercialize, lease, sell and/or sublicense VQD-001 and VQD-002. We
have
initiated three Phase I/IIa clinical trials since acquiring the license rights
to VQD-001 and VQD-002.
As
a
result of this acquisition, we have undertaken funding development of VQD-001
and VQD-002, which has significantly increased our expected cash expenditures
and will continue to increase our expenditures over the next 12 months and
thereafter. The completion of development of VQD-001 and VQD-002, both of which
are only in early stages of clinical development, is very lengthy and expensive
process. Until such development is complete and the FDA (or the comparable
regulatory authorities of other countries) approves VQD-001 and VQD-002 for
sale, we will not be able to sell these products.
Since
inception, we have incurred an accumulated deficit of $28,540,556 through
December 31, 2006. For the year ended December 31, 2006, we had losses from
continuing operations of $5,175,570 and used $3,955,017 in cash from continuing
operating activities for year ended December 31, 2006. As of December 31, 2006,
we had working capital of $1,442,522 and cash and cash equivalents of
$2,931,265.
Management
expects our losses to increase over the next several years, due to the expansion
of our drug development business, costs associated with the clinical development
of VQD-001 and VQD-002. These matters raise substantial doubt about our ability
to continue as a going concern.
On
October 18, 2006, we sold 7,891,600 shares of our common stock at a price of
$0.50 per share resulting in gross proceeds of approximately $3.95 million.
In
addition to the shares of common stock, we also issued to the investors 5-year
warrants to purchase an aggregate of 2,762,060 shares at an exercise price
of
$0.73 per share. In connection with the private placement, we engaged Paramount
BioCapital, Inc. (“Paramount”), as our exclusive placement agent, and Paramount
in turn engaged various broker-dealers as sub-agents to assist with the
offering. Dr. Lindsay A. Rosenwald is the Chairman, CEO and sole stockholder
of
Paramount and a substantial stockholder of VioQuest. Stephen C. Rocamboli,
a
director of our Company, is
currently employed by Paramount. Until December 2006, Dr. Michael Weiser, also
a
director of our Company, was employed by Paramount, an entity of which Dr.
Rosenwald is the chairman and sole stockholder. In
consideration for their services, we paid an aggregate of approximately $276,000
in commissions to the placement agents (including sub-agents) in connection
with
the offering, of which $56,000 was paid to Paramount, plus an additional $30,000
as reimbursement for expenses. We also issued to the placement agents 5-year
warrants to purchase an aggregate of 394,580 shares of common stock at a price
of $0.55 per share. Based upon the Black-Scholes option pricing valuation model,
the investor warrants are estimated to be valued at approximately $1,363,000.
Based upon the Black-Scholes option pricing valuation model, the placement
agents’ warrants are estimated to be valued at approximately $195,000.
On
October 18, 2005, we sold 11,179,975 shares of our common stock at a price
of
$0.75 per share resulting in gross proceeds of approximately $8.38 million.
In
addition to the shares of our common stock, investors also received 5-year
warrants to purchase an aggregate of 4,471,975 shares of our common stock at
an
exercise price of $1.00 per share. . In connection with the private placement,
we engaged Paramount as our exclusive placement agent. Dr. Lindsay A. Rosenwald
is the Chairman, CEO and sole stockholder of Paramount and a substantial
stockholder of our Company. Two of our directors, Stephen C. Rocamboli
who is currently employed by Paramount and until December 2006, Dr. Weiser
was
employed by Paramount of which Dr. Rosenwald is the chairman and sole
stockholder, and is also a substantial stockholder of the Company. We
paid
an aggregate of approximately $587,000 in commissions to Paramount in connection
with the offering, plus an accountable expense allowance of $50,000, and issued
5-year warrants to purchase an aggregate of 1,117,997 shares of common stock
at
a price of $1.00 per share. Our net proceeds, after deducting placement agent
fees and other expenses relating to the private placement, were approximately
$7.5 million.
On
February 25, 2004, we completed a private placement of our securities to
accredited investors that resulted in gross proceeds of approximately $7.2
million. Investors in the private placement purchased an aggregate of
approximately 4.8 million shares of our common stock at a price per share of
$1.50 and received 5-year warrants to purchase one share of common stock at
$1.65 per share for every two common shares purchased in the offering (a total
of 2.4 million warrants). In connection with this offering, we issued 482,691
shares of common stock at a price of $1.65 per share to our placement agents.
In
addition, we paid an aggregate of $500,000 in selling agent commissions, of
which Paramount (See note 11 accompanying the consolidated financial statements
included elsewhere in this Annual Report on Form 10-KSB), received $300,000.
Net
proceeds to us, after deducting commissions and other expenses relating to
the
private placement, were approximately $6.7 million.
Management
anticipates that our capital resources will be adequate to fund our operations
through the second quarter of 2007. Additional financing will be required during
2007 in order to continue operations. Our board of directors directed our
management to seek strategic alternatives for our Chiral Quest business
operations on September 29, 2006, which may include the possible sale of that
business. If we are able to sell our Chiral Quest business we may receive cash
proceeds from the sale, which we would utilize to further the development of
our
two anti-cancer drug candidates. The most likely source of financing includes
the private sale of our equity or debt securities, or bridge loans to us from
third party lenders. However, changes may occur that would consume available
capital resources before that time. Our working capital requirements will depend
upon numerous factors, which include, the progress of its drug development
and
clinical programs, including associated costs relating to milestone payments,
license fees, manufacturing costs, regulatory approvals, and the hiring of
additional employees.
Our
net
cash used in continuing operating activities for the year ended December 31,
2006 was $3,955,017. Our net cash used in operating activities primarily
resulted from a net loss of $5,175,570 offset by non-cash items consisting
of
the impact of expensing employee and director stock options in accordance with
FAS 123R of $830,715, the impact of expensing scientific advisory board member
consultants’ options in accordance with EITF 96-18 for $33,830, and depreciation
of $6,304, Other uses of cash in continuing operating activities include an
increase in other current assets, which primarily consists of prepaid clinical
research organization costs, prepaid manufacturing costs of $432,068 attributed
to our two oncology compounds development sites. Additionally, an increase
in
accounts payable of $756,381 which is primarily attributed to clinical
development costs, clinical regulatory costs, legal, accounting
fees.
Our
net
cash used in continuing investing activities for the year ended December 31,
2006 totaled $28,406, which resulted from capital expenditures were attributed
to the purchases of computer and office equipment for the Basking Ridge, New
Jersey facility.
Our
net
cash provided by financing activities for the year ended December 31, 2006
was
$3,649,246. Financing activities consisted of approximately $3.65 million
received from our October 2006 private placement of approximately 7.9 million
shares of our common stock at a price per share of $0.50, net of approximately
$296,000 of costs associated to the agreement with Paramount, which served
as
our placement agent.
As
part
of our plan for development, we anticipate hiring additional full-time employees
in the medical, clinical and finance functions. In addition, we will continue
to
use senior advisors, consultants, clinical research organizations and third
parties to perform certain aspects of our products’ development, manufacturing,
clinical and preclinical development, and regulatory and quality assurance
functions.
At
our
current and desired pace of clinical development of our two products, currently
in Phase I/IIa clinical trials, over the next 12 months we expect to spend
approximately $7.0 million on clinical trials (including milestone payments
that
we expect to be triggered under the license agreements relating to our product
candidates, maintenance fees payments that we are obligated to pay to the
institutions we licensed our two oncology compounds from, salaries and
consulting fees, pre-clinical and laboratory studies), approximately $130,000
on
facilities, rent and other facilities costs, and approximately $2.7 million
on
general corporate and working capital. Additionally, we have an outstanding
debt balance of $264,623 and approximately $16,000 of interest through December
31, 2006, which was due in October 2006 and is currently due and payable to
Paramount BioSciences, LLC, an affiliate of Paramount. We plan to satisfy the
final portion of debt and interest by the end of the first half of 2007.
Our
working capital requirements will depend upon numerous factors. For example,
with respect to our drug development business, our working capital requirements
will depend on, among other factors, the progress of our drug development and
clinical programs, including associated costs relating to milestone payments,
license fees, manufacturing costs, regulatory approvals, and the hiring of
additional employees.
Additional
capital that we may need in the future may not be available on reasonable terms,
or at all. If adequate financing is not available, we may be required to
terminate or significantly curtail our operations, or enter into arrangements
with collaborative partners or others that may require us to relinquish rights
to certain of our technologies, or potential markets that we would not otherwise
relinquish.
Contractual
Obligations
License
with The Cleveland Clinic Foundation. We
have
an exclusive, worldwide license agreement with CCF for the rights to develop,
manufacture, use, commercialize, lease, sell and/or sublicense VQD-001. We
are
obligated to make an annual license maintenance payment until the first
commercial sale of VQD-001, at which time we are no longer obligated to pay
this
maintenance fee. In addition, the license agreement requires us to make payments
in an aggregate amount of up to $4.5 million to CCF upon the achievement of
certain clinical and regulatory milestones. Should VQD-001 become
commercialized, we will be obligated to pay CCF an annual royalty based on
net
sales of the product. In the event that we sublicense VQD-001 to a third party,
we will be obligated to pay CCF a portion of fees and royalties received from
the sublicense. We hold the exclusive right to negotiate for a license on any
improvements to VQD-001 and have the obligation to use all commercially
reasonable efforts to bring SSG to market. We have agreed to prosecute and
maintain the patents associated with VQD-001 or provide notice to CCF so that
it
may so elect. The license agreement shall automatically terminate upon
Greenwich’s bankruptcy and upon the date of the last to expire claim contained
in the patents subject to the license agreement. The license agreement may
be
terminated by CCF, upon notice with an opportunity for cure, for our failure
to
make required payments or its material breach, or by us, upon thirty day’s
written notice.
License
with the University of South Florida Research Foundation,
Inc.
We have
an exclusive, worldwide license agreement with USF for the rights to develop,
manufacture, use, commercialize, lease, sell and/or sublicense VQD-002. Under
the terms of the license agreement, we have agreed to sponsor research involving
VQD-002 annually for the term of the license agreement. In addition, the
license agreement requires us to make payments in an aggregate amount of up
to
$5.8 million to USF upon the achievement of certain clinical and regulatory
milestones. Should a product incorporating VQD-002 be commercialized, we are
obligated to pay to USF an annual royalty based on net sales of the product.
In
the event that we sublicense VQD-002 to a third party, we are obligated to
pay
USF a portion of fees and royalties received from the sublicense. We hold a
right of first refusal to obtain an exclusive license on any improvements to
VQD-002 and have the obligation to use all commercially reasonable efforts
to
bring VQD-002 to market. We have agreed to prosecute and maintain the patents
associated with VQD-002 or provide notice to USF so that it may so elect. The
license agreement shall automatically terminate upon Greenwhich’s bankruptcy or
upon the date of the last to expire claim contained in the patents subject
to
the license agreement. The license agreement may be terminated by USF, upon
notice with an opportunity for cure, for our failure to make required payments
or its material breach, or by us, upon six month’s written notice.
The
following table summarizes our long-term contractual obligations at
December 31, 2006:
|
|
Payments
due by period
|
|
|
|
Total
|
|
Less
than
1
year
|
|
1-3
years
|
|
3-5
years
|
|
More
than 5 years
|
|
Contractual
Obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing
Operating Lease Obligations (1)
|
|
$
|
494,000
|
|
$
|
97,000
|
|
$
|
295,000
|
|
$
|
102,000
|
|
$
|
-
|
|
Discontinued
Operating Lease Obligations (1)
|
|
|
799,000
|
|
|
331,000
|
|
|
468,000
|
|
|
-
|
|
|
-
|
|
Total
|
|
$
|
1,293,000
|
|
$
|
428,000
|
|
$
|
763,000
|
|
$
|
102,000
|
|
$
|
-
|
|
(1)
|
Operating
Lease Obligations are payment obligations under an “operating lease” as
classified by FASB Statement of Financial Accounting Standards No.
13.
According to SFAS 13, any lease that does not meet the criteria for
a
“capital lease” is considered an “operating
lease.”
|
Critical
Accounting Policies and Estimates
Accounting
for Stock-Based Compensation
Prior
to
January 1, 2006, as permitted by SFAS No. 123, we accounted for share-based
payments to employees using the intrinsic value method under the recognition
and
measurement principles of Accounting Principles Board Opinion No. 25, Accounting
for Stock Issued to Employees “APB No. 25”, and related interpretations. Under
this method, compensation cost is measured as the amount by which the market
price of the underlying stock exceeds the exercise price of the stock option
at
the date at which both the number of options granted and the exercise price
are
known. As previously permitted by the Statement of Financial Accounting
Standards No. 123 “SFAS No. 123”, we had elected to apply the
intrinsic-value-based method of accounting under APB No. 25 described above,
and
adopted the disclosure only requirements of SFAS No. 123, and provided pro
forma
information for the effects of using a fair value basis for all options.
We
adopted SFAS No. 123R, Share-Based Payment and related interpretations on
January 1, 2006 for its employee and director stock options plan, using the
modified prospective method which requires that share-based expense recognized
includes: (a) share-based expense for all awards granted prior to, but not
yet
vested, as of the adoption date and (b) share-based expense for all awards
granted subsequent to the adoption date. Since the modified prospective
application method is being used, there is no cumulative effect adjustment
upon
the adoption of SFAS No. 123R, and our financial statements as of and for the
year ended December 31, 2005 do not reflect any restated amounts. No
modifications were made to outstanding options prior to the adoption of SFAS
No.
123R, and we did not change the quantity, type or payment arrangements of any
share-based payment programs.
SFAS
No.
123R requires that compensation cost relating to share-based payment
transactions be recognized as an expense in the financial statements, and that
measurement of that cost be based on the estimated fair value of the equity
or
liability instrument issued. Under SFAS No. 123R, the pro forma disclosures
previously permitted under SFAS No. 123, Accounting for Stock-Based Compensation
“SFAS No. 123” are no longer an alternative to financial statement recognition.
SFAS No. 123R also required that forfeitures be estimated and recorded over
the
vesting period of the instrument.
We
account for stock options granted to non-employees on a fair value basis using
the Black-Scholes option pricing method in accordance with SFAS 123R and
Emerging Issues Task Force No. 96-18, “Accounting for Equity Instruments that
are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services. The initial non-cash charge to operations for
non-employee options with vesting is subsequently adjusted at the end of each
reporting period based upon the change in the fair value of our common stock
until such options vest. We use the same valuation methodologies and assumptions
in estimating the fair value of options under both SFAS No. 123R and the pro
forma disclosures under SFAS No. 123.
Research
and Development Expense.
Research
and development expenditures are expensed as incurred. We often contract with
third parties to facilitate, coordinate and perform agreed upon research and
development activities. To ensure that research and development costs are
expensed as incurred, we measure and record prepaid assets or accrue expenses
on
a monthly basis for such activities based on the work performed under the
contracts.
These
contracts typically call for the payment of fees for services at the initiation
of the contract and/or upon the achievement of certain clinical trial
milestones. In the event that we prepay fees for future milestones, we
record the prepayment as a prepaid asset and amortize the asset into research
and development expense over the period of time the contracted research and
development services are performed. Most professional fees are incurred
throughout the contract period. These professional fees are expensed based
on their percentage of completion at a particular date.
These
contracts generally include pass through fees. Pass through fees include,
but are not limited to, regulatory expenses, investigator fees, travel costs,
and other miscellaneous costs including shipping and printing fees. Because
these fees are incurred at various times during the contract term and they
are
used throughout the contract term, we record a monthly expense allocation to
recognize the fees during the contract period. Fees incurred to set up the
clinical trial are expensed during the setup period.
Off-Balance
Sheet Arrangements
We
do not
have any off-balance sheet arrangements.
Recently
Issued Accounting Standards
In
December 2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Staff Position EITF 00-19-2 (“FSP 00-19-2”), Accounting
for Registration Payment Arrangements. FSP
00-19-2 addresses an issuer’s accounting for registration payment arrangements
by specifying that the contingent obligation to make future payments or
otherwise transfer consideration under a registration payment arrangement,
wither issued as a separate agreement or included as a provision of a financial
instrument or other agreement, should be separately recognized and measured
in
accordance with FASB Statement No. 5, Accounting
for Contingencies. FSP
00-19-2 will be effective for fiscal years beginning after December 15, 2006,
and interim periods within those fiscal years. We currently believe that the
adoption of FSP 00-19-2 will have no material impact on our consolidated
financial position or results of operations.
In
June
2006, the FASB issued FASB Interpretation No. 48, Accounting
for Uncertainty in Income Taxes, an interpretation of FASB Statement No.
109, Accounting for
Income Taxes (“FIN
48”).
FIN
48
clarifies the accounting for uncertainty in income taxes recognized in a
company’s financial statements in accordance with FASB Statement No.
109.
FIN
48
stipulates a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to
be
taken in a tax return. FIN 48 also provides guidance on derecognition,
classification, and interest and penalties. The provisions of FIN 48 are to
be
effective for our fiscal year beginning January 1, 2007. We have determined
that
the impact that uncertain tax positions will not have a material affect on
our
financial position or results of operations.
ITEM
7. CONSOLIDATED FINANCIAL STATEMENTS
For
a
list of the consolidated financial statements filed as part of this report,
see
the Index to Consolidated Financial Statements beginning at Page F-1 of this
annual report.
ITEM
8. CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM
8A. CONTROLS AND PROCEDURES
As
of
December 31, 2006, we carried out an evaluation, under the supervision and
with
the participation of our chief executive and chief financial officer, of the
effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities
Exchange Act of 1934, as amended). Based upon that evaluation, our chief
executive officer and chief financial officer concluded that our disclosure
controls and procedures were effective as of that date in alerting them on
a
timely basis to material information required to be disclosed in our periodic
reports to the Securities and Exchange Commission. There were no changes in
our
internal controls over financial reporting during the quarter ended December
31,
2006 that have materially affected, or are likely to materially affect, our
internal controls over financial reporting.
ITEM
8B. OTHER INFORMATION
None.
PART
III
ITEM
9. DIRECTORS,
EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS; COMPLIANCE WITH SECTION
16(a)
OF THE EXCHANGE ACT
Information
in response to this Item is incorporated herein by reference to our 2007 Proxy
Statement to be filed pursuant to Regulation 14A within 120 days after
the end of the fiscal year covered by this Form 10-KSB.
ITEM
10. EXECUTIVE
COMPENSATION
Information
in response to this Item is incorporated herein by reference to our 2007 Proxy
Statement to be filed pursuant to Regulation 14A within 120 days after
the end of the fiscal year covered by this Form 10-KSB.
ITEM
11. SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDERS
MATTERS
Information
in response to this Item is incorporated herein by reference to our 2007 Proxy
Statement to be filed pursuant to Regulation 14A within 120 days after
the end of the fiscal year covered by this Form 10-KSB.
ITEM
12. CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS
Information
in response to this Item is incorporated herein by reference to our 2007 Proxy
Statement to be filed pursuant to Regulation 14A within 120 days after
the end of the fiscal year covered by this Form 10-KSB.
Exhibit
No.
|
|
Description
|
2.1
|
|
Agreement
and Plan of Merger dated July 1, 2005 by and among the Company, VQ
Acquisition Corp. and Greenwich Therapeutics, Inc. (incorporated
by
reference to Exhibit 2.1 to the Company’s Form 10-QSB filed November 14,
2005).
|
|
|
|
2.2
|
|
First
Amendment to Agreement and Plan of Merger dated August 19, 2005 by
and
among the Company, VQ Acquisition Corp. and Greenwich Therapeutics,
Inc.
(incorporated by reference to Exhibit 2.2 to the Company’s Form 10-QSB
filed November 14, 2005).
|
|
|
|
2.3
|
|
Agreement
and Plan of Merger dated October 14, 2005 by and between VioQuest
Pharmaceuticals, Inc. and VioQuest Delaware, Inc. (incorporated by
reference to Exhibit 10.1 to the Company’s Form 8-K filed October 20,
2005).
|
|
|
|
3.1
|
|
Certificate
of Incorporation, as amended to date (incorporated by reference to
Exhibit
3.1 to the Company’s Form 8-K filed October 20, 2005).
|
|
|
|
3.2
|
|
Bylaws,
as amended to date (incorporated by reference to Exhibit 3.2 of
Registrant’s Annual Report on Form 10-KSB for the year ended December 31,
2003).
|
|
|
|
4.1
|
|
Option
Agreement No. LL-1 dated May 6 ,
2003
issued to Princeton Corporate Plaza, LLC. (incorporated by reference
to
Exhibit 4.1 to the Registrant’s Form 10-QSB for the period ended June 30,
2003).
|
|
|
|
4.2
|
|
Form
of Option Agreement dated May 6,
2003
issued to Princeton Corporate Plaza, LLC (incorporated by reference
to
Exhibit 4.2 to the Registrant’s Form 10-QSB for the period ended June 30,
2003).
|
|
|
|
4.3
|
|
Schedule
of Options substantially identical to Exhibit 4.3 (incorporated by
reference to Exhibit 4.3 to the Registrant’s Form 10-QSB for the period
ended June 30, 2003).
|
|
|
|
4.4
|
|
Form
of Common Stock Purchase Warrant issued in connection with February
2004
private placement (incorporated by reference to the Registrant’s Form SB-2
filed March 26, 2004 (File No. 333-113980)).
|
|
|
|
4.5
|
|
Form
of Common Stock Purchase Warrant issued in connection with the October
2005 private placement (incorporated by reference to Exhibit 4.1
of the
Registrant’s Form SB-2 filed November 17, 2005 (File No.
333-129782)).
|
|
|
|
4.6
|
|
Form
of Common Stock Purchase Warrant issued to placement agents in connection
with the October 2005 private placement (incorporated by reference
to
Exhibit 4.2 of the Registrant’s Form SB-2 filed November 17, 2005 (File
No. 333-129782)).
|
4.7
|
|
Form
of Common Stock Purchase Warrant issued in connection with the October
2005 acquisition of Greenwich Therapeutics, Inc. (incorporated by
reference to Exhibit 4.3 of the Registrant’s Form SB-2 filed November 17,
2005 (File No. 333-129782)).
|
|
|
|
4.8
|
|
Form
of warrant issued to investors in October 18, 2006 private placement
(incorporated by reference to Exhibit 4.1 to the Registrant’s Current
Report on Form 8-K filed on October 24, 2006).
|
|
|
|
4.9
|
|
Form
of warrant issued to placement agents in October 18, 2006 private
placement (incorporated by reference to Exhibit 4.2 to the Registrant’s
Current Report on Form 8-K filed on October 24, 2006).
|
|
|
|
10.1
|
|
License
Agreement dated on or about October 27, 2000, as amended, between
Chiral
Quest, LLC and The Penn State Research Foundation (incorporated by
reference to Exhibit 10.2 to the Registrant’s Form 10-QSB for the period
ended March 31, 2003).
|
|
|
|
10.2
|
|
Consulting
Agreement dated May 15, 2003 between the Registrant and Xumu Zhang,
Ph.D.
(incorporated by reference to Exhibit 10.1 to the Registrant’s Form 10-QSB
for the period ended June 30, 2003).
|
|
|
|
10.3
|
|
2003
Stock Option Plan (incorporated by reference to Exhibit 10.4 to the
Registrant’s Form 10-KSB for the year ended December 31, 2003).
|
|
|
|
10.4
|
|
Employment
Agreement dated February 1, 2005 between the Company and Daniel Greenleaf
(incorporated by reference to Exhibit 10.16 to the Registrant’s Annual
Report on Form 10-KSB for the year ended December 31, 2004).
|
|
|
|
10.5
|
|
License
Agreement dated February 8, 2005 by and between Greenwich Therapeutics,
Inc. and The Cleveland Clinic Foundation (incorporated by reference
to
Exhibit 10.6 of the Registrant’s Form SB-2 filed November 17, 2005 (File
No. 333-129782)).++
|
|
|
|
10.6
|
|
License
Agreement dated April 19, 2005 by and between Greenwich Therapeutics,
Inc.
and the University of South Florida Research Foundation, Inc.
(incorporated by reference to Exhibit 10.7 of the Registrant’s Form SB-2
filed November 17, 2005 (File No. 333-129782)).++
|
|
|
|
10.7
|
|
Letter
Agreement between the Company and Pamela Harris dated February 15,
2006
(incorporated by reference to Exhibit 10.8 to the Registrant’s Annual
Report on Form 10-KSB for the year ended December 31, 2005).
|
|
|
|
10.8
|
|
Form
of Subscription Agreement issued in connection with the October 2005
private placement (incorporated by reference to Exhibit 10.9 to the
Registrant’s Annual Report on Form 10-KSB for the year ended December 31,
2005).
|
|
|
|
10.9
|
|
Summary
terms of 2006 management bonus compensation plan (incorporated by
reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K
filed on May 25, 2006).
|
|
|
|
10.10
|
|
Summary
terms of outside director compensation (incorporated by reference
to
Exhibit 10.2 to the Registrant’s Current Report on Form 8-K filed on May
25, 2006).
|
|
|
|
10.11
|
|
Severance
Benefits Agreement dated August 8, 2006 by and between Brian Lenz
and the
Company (incorporated by reference to Exhibit 10.3 to the Registrant’s
Quarterly Report on Form 10-QSB for the period ended June 30, 2006).
|
|
|
|
10.12
|
|
Letter
Agreement between the Company and Lawrence Akinsanmi effective October
1,
2006 (incorporated by reference to Exhibit 10.1 to the Registrant’s
Current Report on Form 8-K filed on October 6, 2006).
|
|
|
|
10.13
|
|
Form
of subscription agreement between the Company and investors accepted
as of
October 18, 2006 (incorporated by reference to Exhibit 10.1 to the
Registrant’s Current Report on Form 8-K filed on October 24, 2006).
|
|
|
|
10.14
|
|
First
Amendment to Lease dated September 15, 2006 between the Company and
Mount
Airy Associates, LLC (incorporated by reference to Exhibit 10.2 to
the
Registrant’s Quarterly Report on Form 10-QSB for the period ended
September 30, 2006).
|
|
|
|
10.15
|
|
Form
of Stock Option Agreement for use under the 2003 Stock Option
Plan.
|
|
|
|
21.1
|
|
Subsidiaries
of the Registrant.
|
|
|
|
23.1
|
|
Consent
of J.H. Cohn LLP.
|
|
|
|
31.1
|
|
Certification
of Chief Executive Officer.
|
|
|
|
31.2
|
|
Certification
of Chief Financial Officer.
|
|
|
|
32.1
|
|
Certification
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.2
|
|
Certification
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
++
Confidential treatment has been granted as to certain portions of this exhibit
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
Information
in response to this Item is incorporated herein by reference to our 2007 Proxy
Statement to be filed pursuant to Regulation 14A within 120 days after
the end of the fiscal year covered by this form 10-KSB.
SIGNATURES
In
accordance with Section 13 or 15(d) of the Securities Exchange Act, VioQuest
Pharmaceuticals, Inc. has duly caused this report to be signed on its behalf
by
the undersigned, thereunto duly authorized, on March 22, 2007.
|
|
|
|
VioQuest
Pharmaceuticals, Inc.
|
|
|
|
|
By: |
/s/
Daniel Greenleaf |
|
Daniel
Greenleaf
President
and Chief Executive Officer
|
In
accordance with the Securities Exchange Act, this report has been signed below
by the following persons on behalf of VioQuest Pharmaceuticals, Inc. and in
the
capacities and on the dates indicated.
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/
Daniel Greenleaf
|
|
President
& Chief Executive Officer and Director
|
|
March
22, 2007
|
Daniel
Greenleaf
|
|
(Principal
Executive
Officer) |
|
|
|
|
|
|
|
/s/
Brian Lenz
|
|
Chief
Financial Officer, and Treasurer
|
|
March
22, 2007
|
Brian
Lenz
|
|
(Principal
Financial and Accounting Officer)
|
|
|
|
|
|
|
|
/s/
Vincent M. Aita
|
|
Director
|
|
March
22, 2007
|
Vincent
M. Aita
|
|
|
|
|
|
|
|
|
|
/s/
Johnson Y. N. Lau
|
|
Director
|
|
March
22, 2007
|
Johnson
Y. N. Lau
|
|
|
|
|
|
|
|
|
|
/s/
Stephen C. Rocamboli
|
|
Chairman
of the Board
|
|
March
22, 2007
|
Stephen
C. Rocamboli
|
|
|
|
|
|
|
|
|
|
/s/
Stephen A. Roth
|
|
Director
|
|
March
22, 2007
|
Stephen
A. Roth
|
|
|
|
|
|
|
|
|
|
/s/
Michael Weiser
|
|
Director
|
|
March
22, 2007
|
Michael
Weiser
|
|
|
|
|
|
|
|
|
|
/s/
Xumu Zhang
|
|
Director
|
|
March
22, 2007
|
Xumu
Zhang
|
|
|
|
|
Index
to Consolidated Financial Statements
|
|
Page
|
|
Report
of J.H. Cohn LLP
|
|
|
F-2
|
|
|
|
|
|
|
Consolidated
Balance Sheets as of December 31, 2006 and 2005
|
|
|
F-3
|
|
|
|
|
|
|
Consolidated
Statements of Operations for the Years Ended December 31, 2006 and
2005
|
|
|
F-4
|
|
|
|
|
|
|
Consolidated
Statements of Changes in Stockholders’ Equity for the Years Ended
December 31, 2006 and 2005
|
|
|
F-5
|
|
|
|
|
|
|
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2006 and
2005
|
|
|
F-6
|
|
|
|
|
|
|
Notes
to Consolidated Financial Statements
|
|
|
F-7
to F-21
|
|
Report
of Independent Registered Public Accounting Firm
VioQuest
Pharmaceuticals, Inc.
We
have
audited the accompanying consolidated balance sheets of VioQuest
Pharmaceuticals, Inc. and Subsidiaries as of December 31, 2006 and 2005, and
the
related consolidated statements of operations, changes in stockholders' equity
and cash flows for the years then ended. These consolidated financial statements
are the responsibility of the Company's management. Our responsibility is to
express an opinion on these consolidated financial statements based on our
audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining,
on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used
and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In
our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the consolidated financial position of VioQuest
Pharmaceuticals, Inc. and Subsidiaries as of December 31, 2006 and 2005, and
their results of operations and cash flows for the years then ended, in
conformity with accounting principles generally accepted in the United States
of
America.
The
accompanying consolidated financial statements have been prepared assuming
that
the Company will continue as a going concern. As discussed in Note 1 to the
consolidated financial statements, the Company has an accumulated deficit at
December 31, 2006 and has generated recurring losses and negative net cash
flows
from operating activities. These matters raise substantial doubt about the
Company's ability to continue as a going concern. Management's plans concerning
these matters are also described in Note 1. The consolidated financial
statements do not include any adjustments that might result from the outcome
of
this uncertainty.
As
discussed in Note 2 to the consolidated financial statements, the Company
changed the manner in which it accounts for share-based compensation in fiscal
2006.
/s/ J.H.
Cohn LLP
Roseland,
New Jersey
March
6,
2007
CONSOLIDATED
BALANCE SHEETS
AS
OF DECEMBER 31,
|
|
2006
|
|
2005
|
|
ASSETS
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
2,931,265
|
|
$
|
6,021,399
|
|
Prepaid
expenses and other current assets
|
|
|
442,013
|
|
|
9,945
|
|
Current
assets associated with discontinued operations
|
|
|
1,056,808
|
|
|
892,092
|
|
Total
Current Assets
|
|
|
4,430,086
|
|
|
6,923,436
|
|
|
|
|
|
|
|
|
|
NON-CURRENT
ASSETS ASSOCIATED WITH DISCONTINUED OPERATIONS
|
|
|
1,339,627
|
|
|
1,424,883
|
|
PROPERTY
AND EQUIPMENT, NET
|
|
|
43,378
|
|
|
21,276
|
|
SECURITY
DEPOSITS
|
|
|
15,232
|
|
|
9,708
|
|
TOTAL
ASSETS
|
|
$
|
5,828,323
|
|
$
|
8,379,303
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,031,458
|
|
$
|
275,077
|
|
Accrued
compensation and related taxes
|
|
|
245,475
|
|
|
360,000
|
|
Accrued
expenses
|
|
|
180,440
|
|
|
35,000
|
|
Note
payable - Paramount BioSciences, LLC
|
|
|
264,623
|
|
|
264,623
|
|
Current
liabilities associated with discontinued operations
|
|
|
1,265,568
|
|
|
1,105,594
|
|
TOTAL
LIABILITIES
|
|
|
2,987,564
|
|
|
2,040,294
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
Preferred
stock; $0.001 par value: 10,000,000 shares authorized, 0 shares issued
and
outstanding at December 31, 2006 and 2005
|
|
|
-
|
|
|
-
|
|
Common
stock; $0.001 par value: 100,000,000 shares authorized at December
31,
2006 and 2005 respectively, 54,621,119 shares issued and outstanding
at
December 31, 2006, and 46,729,519 shares issued and outstanding at
December 31, 2005
|
|
|
54,621
|
|
|
46,729
|
|
Additional
paid-in capital
|
|
|
31,326,694
|
|
|
26,561,672
|
|
Accumulated
deficit
|
|
|
(28,540,556
|
)
|
|
(20,269,392
|
)
|
Total
Stockholders' Equity
|
|
|
2,840,759
|
|
|
6,339,009
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
$
|
5,828,323
|
|
$
|
8,379,303
|
|
See
accompanying notes to consolidated financial statements.
CONSOLIDATED
STATEMENTS OF OPERATIONS
FOR
THE YEARS ENDED DECEMBER 31,
|
|
2006
|
|
2005
|
|
REVENUE
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
In-process
research and development
|
|
|
-
|
|
|
7,975,218
|
|
Research
and development
|
|
|
1,819,736
|
|
|
-
|
|
Selling,
general and administrative
|
|
|
3,455,225
|
|
|
2,419,442
|
|
Depreciation
|
|
|
6,304
|
|
|
1,646
|
|
Total
Operating Expenses
|
|
|
5,281,265
|
|
|
10,396,306
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS
|
|
|
(5,281,265
|
)
|
|
(10,396,306
|
)
|
|
|
|
|
|
|
|
|
INTEREST
INCOME, NET
|
|
|
105,695
|
|
|
42,422
|
|
|
|
|
|
|
|
|
|
LOSS
FROM CONTINUING OPERATIONS
|
|
|
(5,175,570
|
)
|
|
(10,353,884
|
)
|
|
|
|
|
|
|
|
|
LOSS
FROM DISCONTINUED OPERATIONS, NET OF TAX BENEFIT
|
|
|
(3,095,594
|
)
|
|
(2,480,745
|
)
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$
|
(8,271,164
|
)
|
$
|
(12,834,629
|
)
|
|
|
|
|
|
|
|
|
NET
LOSS PER SHARE:
|
|
|
|
|
|
|
|
CONTINUING
OPERATIONS
|
|
$
|
(0.13
|
)
|
$
|
(0.47
|
)
|
DISCONTINUED
OPERATIONS
|
|
|
(0.08
|
)
|
|
(0.11
|
)
|
|
|
|
|
|
|
|
|
NET
LOSS PER SHARE - BASIC AND DILUTED
|
|
|
(0.21
|
)
|
|
(0.58
|
)
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING - BASIC AND DILUTED
|
|
|
39,786,686
|
|
|
22,034,198
|
|
See
accompanying notes to consolidated financial statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
FOR
THE YEARS ENDED DECEMBER 31, 2006 and 2005
|
|
Common
Stock
|
|
Additional
Paid-In
|
|
Accumulated
|
|
Total
Stockholders’
|
|
|
|
Shares
|
|
Amount
|
|
Capital
|
|
Deficit
|
|
Equity
|
|
Balance,
January 1, 2005
|
|
|
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)
|
|
|
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 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
|
|
October
18, 2006 private placement, net of $296,554 in financing
costs
|
|
|
7,891,600
|
|
|
7,892
|
|
|
3,641,354
|
|
|
|
|
|
3,649,246
|
|
Stock-based
compensation to employees
|
|
|
|
|
|
|
|
|
1,040,145
|
|
|
|
|
|
1,040,145
|
|
Stock-based
compensation to consultants
|
|
|
|
|
|
|
|
|
83,523
|
|
|
|
|
|
83,523
|
|
Net
loss for the year ended December 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
(8,271,164
|
)
|
|
(8,271,164
|
)
|
Balance,
December 31, 2006
|
|
|
54,621,119
|
|
$
|
54,621
|
|
$
|
31,326,694
|
|
$
|
(28,540,556
|
)
|
$
|
2,840,759
|
|
See
accompanying notes to consolidated financial statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
THE YEARS ENDED DECEMBER 31,
|
|
2006
|
|
2005
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
Net
loss
|
|
$
|
(8,271,164
|
)
|
$
|
(12,834,629
|
)
|
Loss
from discontinued operations
|
|
|
3,095,594
|
|
|
2,480,745
|
|
Loss
from continuing operations
|
|
|
(5,175,570
|
)
|
|
(10,353,884
|
)
|
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
|
|
|
6,304
|
|
|
1,646
|
|
Stock-based
compensation to consultants
|
|
|
33,830
|
|
|
-
|
|
Stock-based
compensation issued to employees
|
|
|
830,715
|
|
|
190,000
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
(Increase)
in prepaid expenses and other current assets
|
|
|
(432,068
|
)
|
|
(9,945
|
)
|
(Increase)
in security deposits
|
|
|
(5,524
|
)
|
|
(9,708
|
)
|
Increase
in accounts payable
|
|
|
756,381
|
|
|
275,077
|
|
Increase
in accrued expenses
|
|
|
30,915
|
|
|
395,000
|
|
Net
cash used in continuing operating activities
|
|
|
(3,955,017
|
)
|
|
(1,536,596
|
)
|
Net
cash used in discontinued operating activities
|
|
|
(2,502,814
|
)
|
|
(2,205,258
|
)
|
Net
cash used in operating activities
|
|
|
(6,457,831
|
)
|
|
(3,741,854
|
)
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
Payments
for Greenwich acquisition
|
|
|
-
|
|
|
(170,234
|
)
|
Payments
for purchased property and equipment
|
|
|
(28,406
|
)
|
|
(21,276
|
)
|
Net
cash used in continuing investing activities
|
|
|
(28,406
|
)
|
|
(191,510
|
)
|
Net
cash used in discontinued investing activities
|
|
|
(253,143
|
)
|
|
(594,193
|
)
|
Net
cash used in investing activities
|
|
|
(281,549
|
)
|
|
(785,703
|
)
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
Proceeds
from private placement of common stock, net
|
|
|
3,649,246
|
|
|
7,748,032
|
|
Payment
of note payable to Paramount BioSciences
|
|
|
-
|
|
|
(264,623
|
)
|
Net
cash provided by financing activities
|
|
|
3,649,246
|
|
|
7,483,409
|
|
NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
|
|
(3,090,134
|
)
|
|
2,955,852
|
|
CASH
AND CASH EQUIVALENTS - BEGINNING OF YEAR
|
|
|
6,021,399
|
|
|
3,065,547
|
|
CASH
AND CASH EQUIVALENTS - END OF YEAR
|
|
$
|
2,931,265
|
|
$
|
6,021,399
|
|
Non-Cash
Transactions:
1.
See
Note 4 for discussion of the acquisition of Greenwich Therapeutics, Inc. and
consideration (principally, shares, warrants and the assumption of debt) issued
and assumed.
2.
The
Company incurred $823,869 of debt from the acquisition of Greenwich
Therapeutics, Inc., in October 2005.
3.
Of the
total debt assumed by the Company, $264,623 was paid to Paramount BioCapital,
Inc. from proceeds of the October 2005 private placement of the Company’s common
stock, $294,623 was paid through the issuance of 392,830 shares of its common
stock to Paramount BioCapital, Inc., and $264,623 is payable to Paramount
BioSciences, LLC, as a result of the Company’s successful completion of a
combined financing, of at least $10 million, which includes the $8.4 million
financing in October 2005 and $3.95 million financing in October 2006. See
Note
11.
4.
The
Company reincorporated from Minnesota to Delaware in October 2005, resulting
in
an equity reclassification of $160,451 from the change in the par value of
its
common stock from $0.01 to $0.001.
See
accompanying notes to consolidated financial statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
NOTE
1 NATURE
OF OPERATIONS AND LIQUIDITY
(A)
Basis of Presentation
The
accompanying consolidated financial statements include the accounts of VioQuest
Pharmaceuticals, Inc. and its subsidiaries. All significant intercompany
accounts and transactions have been eliminated in consolidation. The functional
currency of Chiral Quest, Ltd., Jiashan, China, a wholly-owned, discontinued
subsidiary of the Company, is the United States Dollar. As such, all transaction
gains and losses are recorded in discontinued operations.
On
September 29, 2006, the Company’s board of directors directed its management to
seek strategic alternatives with respect to the Company’s Chiral Quest, Inc.
subsidiary (“Chiral Quest”), which may include a sale or other disposition of
the operating assets of that business. Accordingly, the results of Chiral
Quest’s products and services business and the assets and liabilities are
presented in these financial statements as discontinued operations. Chiral
Quest
had accounted for all sales of the Company from its inception. The Company’s
continuing operations, which have not generated any revenues, will focus on
the
drug development operations of VioQuest Pharmaceuticals, Inc. and accordingly,
the Company has only one segment. As a result, the Company no longer provides
segment reporting. No provision has been made to reduce the carrying amounts
of
the assets of the discontinued operations as they approximate their estimated
net realizable values. See Note 3.
The
balance sheets as of December 31, 2006 and December 31, 2005 and the statements
of operations and cash flows for the years then ended include reclassifications
primarily to reflect discontinued operations.
(B)
Nature of Continuing Operations
Since
August 2004, the Company has focused on acquiring technologies for
purposes
of development and commercialization of pharmaceutical drug candidates for
the
treatment of oncology and antiviral diseases and disorders for which there
are
unmet medical needs. In accordance with this business plan, in October 2005,
the
Company acquired in a merger transaction Greenwich Therapeutics, Inc.,
(“Greenwich”), a privately-held New York-based biotechnology company that held
exclusive rights to develop and commercialize two oncology drug candidates
-
sodium stibogluconate or VQD-001, and triciribine-Phosphate or VQD-002. The
rights to these two oncology drug candidates, VQD-001 and VQD-002, are governed
by license agreements with The Cleveland Clinic Foundation and the University
of
South Florida Research Foundation, respectively. As a result of the Company’s
acquisition of Greenwich, the Company holds exclusive rights to develop,
manufacture, use, commercialize, lease, sell and/or sublicense VQD-001 and
VQD-002.
(C)
Liquidity
Since
inception, the Company has incurred an accumulated deficit of $28,540,556
through December 31, 2006. For the years ended December 31, 2006 and 2005,
the
Company had losses from continuing operations of $5,175,570 and $10,353,884,
respectively, and used $3,955,017 and $1,536,596 of cash in continuing operating
activities for the years ended December 31, 2006 and 2005, respectively. For
the
years ended December 31, 2006 and 2005, the Company had a net loss of $8,271,164
(including $5,175,570 from continuing operations) and a net loss of $12,834,629
(including $10,353,884 from continuing operations), respectively, and used
$6,457,831 and $3,741,854 of cash in all operating activities for the years
ended December 31, 2006 and 2005, respectively. Management
expects the Company’s losses from continuing operations to increase over the
next several years, due to the expansion of its drug development business,
and
related costs associated with the clinical development programs of VQD-001
and
VQD-002. These matters raise substantial doubt about the ability of the Company
to continue as a going concern.
As
of
December 31, 2006, we had working capital of $1,442,522 and cash and cash
equivalents of $2,931,265. The
Company has incurred negative cash flow from continuing operations since we
started business. The Company has spent, and expects to continue to spend,
substantial amounts in connection with executing our business strategy,
including our planned development efforts relating to our drug candidates,
our
clinical trials, and our research and development efforts.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
Management
anticipates that the Company’s capital resources will be adequate to fund its
operations through the second quarter of 2007. Additional financing will be
required during 2007 in order to continue operations. On September 29, 2006
the
Company has determined to seek strategic alternatives for its Chiral Quest
business operations, including the possible sale of that business, which may
potentially provide the Company with additional net cash proceeds. See Note
3.
The other most likely sources of additional financing include the private sale
of the Company’s equity or debt securities, or bridge loans to the Company from
third party lenders. However, changes may occur that would consume available
capital resources before that time. The Company’s working capital requirements
will depend upon numerous factors, which include, the progress of its drug
development and clinical programs, including associated costs relating to
milestone payments, maintenance and license fees, manufacturing costs, patent
costs, regulatory approvals, and the hiring of additional employees.
Additional
capital that may be needed by the Company in the future may not be available
on
reasonable terms, or at all. If adequate financing is not available, the Company
may be required to terminate or significantly curtail its operations, or enter
into arrangements with collaborative partners or others that may require the
Company to relinquish rights to certain of its technologies, or potential
markets that the Company would not otherwise relinquish.
NOTE
2
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
(A)
Principles of Consolidation
The
accompanying consolidated financial statements include the accounts of VioQuest
Pharmaceuticals, Inc. and its subsidiaries. All significant intercompany
accounts and transactions have been eliminated in consolidation. The Company
translates the financial statements of its discontinued subsidiary, Chiral
Quest, Ltd. in Jiashan, China, at end of period rates with respect to its
balance sheet and at the average exchange rates with respect to the results
of
its operations and cash flows.
(B)
Cash and Cash Equivalents
The
Company considers all highly-liquid investments with a maturity at the date
of
purchase of three months or less to be cash equivalents.
(C)
Fair Value of Financial Instruments
The
carrying value of financial instruments including cash and cash equivalents
and
accounts payable approximate fair value due to the relatively short maturity
of
these instruments. The carrying value of the note payable to Paramount
BioSciences, LLC, approximates fair value based on the incremental borrowing
rates currently available to the Company for financing with similar terms and
maturities.
(D)
Property and Equipment
Property
and equipment is recorded at cost and depreciated over the estimated useful
lives of the assets, principally using the straight-line method. Amortization
of equipment under capital leases and leasehold improvements is computed over
the shorter of the lease term or estimated useful life of the asset. Additions
and improvements are capitalized, while repairs and maintenance costs are
expensed as incurred. The
estimated useful lives used for depreciation and amortization were three (lease
term), five and seven years for computer equipment and office equipment,
respectively (See Note 5).
(E)
Income Taxes
Under
Statement of Financial Accounting Standards No. 109, “Accounting for Income
Taxes,” (“SFAS 109”) deferred tax assets and liabilities are recognized for the
future tax consequences attributable to temporary differences between the
financial statement carrying amounts of existing assets and liabilities and
their respective tax bases. Deferred tax assets and liabilities are measured
using enacted tax rates expected to apply to taxable income in the years in
which those temporary differences are expected to be recovered or settled.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
Under
SFAS 109, the effect on deferred tax assets and liabilities of a change in
tax
rates is recognized in income in the period that includes the enactment date.
Valuation allowances are established when it is more likely than not that
deferred tax assets will not be realized.
(F)
Stock-Based Compensation
Prior
to
January 1, 2006, as permitted by SFAS No. 123, Accounting for Stock-Based
Compensation (“SFAS No. 123”) the Company accounted for share-based payments to
employees using the intrinsic value method under the recognition and measurement
principles of Accounting Principles Board Opinion No. 25, Accounting for Stock
Issued to Employees (“APB No. 25”), and related interpretations. Under this
method, compensation cost is measured as the amount by which the market price
of
the underlying stock exceeds the exercise price of the stock option at the
date
at which both the number of options granted and the exercise price are known.
As
previously permitted by SFAS No. 123, the Company had elected to apply the
intrinsic-value-based method of accounting under APB No. 25 described above,
and
adopted the disclosure only requirements of SFAS No. 123 and provided pro forma
information for the effects of using a fair value basis for all options.
The
Company adopted SFAS No. 123R, Share-Based Payment (“SFAS No. 123R”) and related
interpretations on January 1, 2006 for its employee and director stock options
plan, using the modified prospective method which requires that share-based
expense recognized includes: (a) share-based expense for all awards granted
prior to, but not yet vested, as of the adoption date and (b) share-based
expense for all awards granted subsequent to the adoption date. Since the
modified prospective application method is being used, there is no cumulative
effect adjustment upon the adoption of SFAS No. 123R, and the Company’s December
31, 2005 financial statements do not reflect any restated amounts. No
modifications were made to outstanding options prior to the adoption of SFAS
No.
123R, and the Company did not change the quantity, type or payment arrangements
of any share-based payment programs. SFAS No. 123R requires that compensation
cost relating to share-based payment transactions be recognized as an expense
in
the financial statements over the related service period, and that measurement
of that cost be based on the estimated fair value of the equity or liability
instrument issued. The pro forma information provided under SFAS No. 123 was
determined on a basis similar in most respects to that of SFAS No. 123R, with
the exception of option forfeitures, which, under SFAS No. 123, had been
accounted for as they occurred.
Under
SFAS No. 123R, the pro forma disclosures previously permitted under SFAS No.
123, are no longer an alternative to financial statement recognition. SFAS
No.
123R also required that forfeitures be estimated and recorded over the vesting
period of the instrument.
The
Company accounts for stock options granted to non-employees on a fair value
basis using the Black-Scholes option pricing method in accordance with SFAS
No.
123R and Emerging Issues Task Force No. 96-18, “Accounting for Equity
Instruments that are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services. The initial non-cash charge to
operations for non-employee options with vesting is subsequently adjusted at
the
end of each reporting period based upon the change in the fair value of the
Company’s common stock until such options vest.
The
following table details the pro forma effect on the Company’s net loss and basic
and diluted net loss per share had compensation expense for stock-based awards
been recorded in the year ended December 31, 2005 based on the fair value method
under SFAS No. 123 instead of the intrinsic value method under APB No. 25:
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
|
|
Year
Ended
December
31, 2005
|
|
Loss
from continuing operations as reported
|
|
$
|
(10,353,884
|
)
|
Deduct:
Stock-based employee compensation
|
|
|
|
|
expense
determined under fair value based
|
|
|
|
|
method
for all awards, net of taxes
|
|
|
(466,991
|
)
|
Pro
forma, loss from continuing operations
|
|
$
|
(10,820,875
|
)
|
|
|
|
|
|
Loss
from discontinued operations as reported
|
|
$
|
(2,480,745
|
)
|
Deduct:
Stock-based employee compensation
|
|
|
|
|
expense
determined under fair value based
|
|
|
|
|
method
for all awards, net of taxes
|
|
|
(236,781
|
)
|
Pro
forma, loss from discontinued operations
|
|
$
|
(2,717,526
|
)
|
|
|
|
|
|
Net
loss as reported
|
|
$
|
(12,834,629
|
)
|
Deduct:
Stock-based employee compensation
|
|
|
|
|
expense
determined under fair value based
|
|
|
|
|
method
for all awards, net of taxes
|
|
|
(703,772
|
)
|
Pro
forma, net loss
|
|
$
|
(13,538,401
|
)
|
|
|
|
|
|
Basic
and diluted loss per share from continuing operations, as
reported
|
|
|
(0.47
|
)
|
Basic
and diluted loss per share from continuing operations, pro
forma
|
|
|
(0.49
|
)
|
Basic
and diluted loss per share from discontinued operations, as
reported
|
|
|
(0.11
|
)
|
Basic
and diluted loss per share from discontinued operations, pro
forma
|
|
|
(0.12
|
)
|
Basic
and diluted net loss per share, as reported
|
|
$
|
(0.58
|
)
|
Basic
and diluted net loss per share, pro forma
|
|
$
|
(0.61
|
)
|
(G)
Use of Estimates
The
preparation of financial statements in accordance with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date
of
the financial statements and the reported amounts of revenue and expenses during
the reporting period. Actual results could differ from those estimates.
(H)
In-Process Research and Development Expense
In-process
research and development costs are expensed as incurred. These expenses are
comprised of the costs associated with the acquisition of
Greenwich.
(I)
Research and Development Expense
Research
and development costs, when incurred in continuing operations, will be expensed
as incurred. These expenses will include the cost of the Company's proprietary
research and development efforts, as well as costs incurred in connection with
the Company's third-party collaboration efforts. We often contract with third
parties to facilitate, coordinate and perform agreed upon research and
development activities. To ensure that research and development costs are
expensed as incurred, we measure and record prepaid assets or accrue expenses
on
a monthly basis for such activities based on the work performed under the
contracts.
These
contracts typically call for the payment of fees for services at the initiation
of the contract and/or upon the achievement of certain clinical trial
milestones.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
In
the
event that we prepay fees for future milestones, we record the prepayment as
a
prepaid asset and amortize the asset into research and development expense
over
the period of time the contracted research and development services are
performed. Most professional fees are incurred throughout the contract
period. These professional fees are expensed based on their percentage of
completion at a particular date.
These
contracts generally include pass through fees. Pass through fees include,
but are not limited to, regulatory expenses, investigator fees, travel costs,
and other miscellaneous costs including shipping and printing fees. Because
these fees are incurred at various times during the contract term and they
are
used throughout the contract term, we record a monthly expense allocation to
recognize the fees during the contract period. Fees incurred to set up the
clinical trial are expensed during the setup period.
(J)
Loss Per Share
Basic
net
loss per share is calculated by dividing net loss by the weighted-average number
of common shares outstanding for the period, excluding 8,564,395 common shares
held in escrow based
upon clinical milestones of VQD-001 and VQD-002, as a result of the acquisition
of Greenwich Therapeutics.
Diluted
net loss per share is the same as basic net loss per share, since potentially
dilutive securities from the assumed exercise of stock options and stock
warrants would have an antidilutive effect because the Company incurred a net
loss during each period presented. The amount of potentially dilutive securities
including options and warrants in the aggregate excluded from the calculation
were 30,294,586 (including the 8,564,395 common shares held in escrow,
15,642,759 warrants, and 6,087,432 stock options) at December 31, 2006 and
26,026,366 at December 31, 2005.
(K)
Concentrations of Credit Risk
Financial
instruments that potentially subject us to concentrations of credit risk consist
primarily of cash and cash equivalents. The Company places its cash with high
quality financial institutions to limit credit exposure.
NOTE
3
DISCONTINUED
OPERATIONS
On
September 29, 2006, the Company’s board of directors directed its management to
seek strategic alternatives for the operations of its Chiral Quest subsidiary
which may include a sale or other disposition of the operating assets of that
business. Accordingly, the business and assets of Chiral Quest are presented
in
these financial statements as discontinued operations. No provision has been
made to reduce the carrying amounts of the assets of discontinued operations
as
management believes they approximate their net realizable values. As of December
31, 2006 and 2005, the current assets of discontinued operations totaled
$1,056,808 and $892,092, respectively, which consisted of accounts receivable,
inventories and prepaid expenses. As of December 31, 2006 and 2005, the
non-current assets of discontinued operations totaled $1,339,627 and $1,424,883,
respectively, which consisted of fixed assets net of accumulated depreciation
and patents net of accumulated amortization, and security deposits. Current
liabilities as of December 31, 2006 and 2005 associated with discontinued
operations totaled $1,265,568 and $1,105,594, respectively, which consisted
of
accounts payable, accrued expenses, and deferred revenue. Revenues for the
years
ended December 31, 2006 and 2005, from discontinued operations totaled
$2,738,652 and $3,804,654 respectively. Loss from discontinued operations for
the years ended December 31, 2006 and 2005, which consisted of revenues less
cost of goods sold, management and consulting fees, research and development,
selling, general and administrative expenses and depreciation and amortization,
totaled $3,095,594 and $2,480,745, respectively.
NOTE
4
MERGER
Greenwich
Therapeutics, Inc.
On
October 18, 2005, the Company completed a merger with Greenwich, a New York
based biotechnology company. In exchange for their shares of Greenwich common
stock and pursuant to the Merger Agreement, the stockholders of Greenwich
received an aggregate of 17,128,790 shares of the Company’s common stock and
five-year warrants to purchase an additional 4,000,000 shares of the Company’s
common stock at an exercise price of $1.41 per share. One-half of the shares
and
warrants issued to Greenwich’s stockholders were placed in escrow and will be
released based upon the achievement of certain milestones as discussed:
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
|
(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).
|
In
the
event the escrowed securities relating to the milestones described above have
not been released to the Greenwich shareholders by June 30, 2008, any escrowed
securities still remaining in the escrow shall be released and delivered to
the
Company for cancellation, and the Greenwich shareholders will have no further
right, title or interest to such escrowed securities.
Dr.
Lindsay A. Rosenwald and certain trusts established for the benefit of Dr.
Rosenwald and his family collectively held approximately 48% of Greenwich’s
capital stock prior to the completion of the Merger. Together, Dr. Rosenwald
and
such trusts also owned approximately 16% of the Company’s common stock prior to
the completion of the Merger. Dr.
Lindsay A. Rosenwald is the Chairman, CEO and sole stockholder of Paramount
BioCapital, Inc. (“Paramount”) and a substantial stockholder of VioQuest. See
Note 11.
Additionally,
as contemplated by the merger agreement, on October 18, 2005, the Company
assumed outstanding indebtedness of Greenwich of $823,869, all of which is
payable to Paramount BioSciences, LLC. (“PBI”), (See Note 11), pursuant to a
promissory note dated October 17, 2005, referred to as the (“Note”).
At
the
closing of the merger, the Note was amended to provide that one-third would
be
converted into securities of the Company on the same terms as the Company’s
October 2005 private placement, one-third of the outstanding indebtedness under
the Note would be repaid upon the completion by the Company of a financing
resulting in gross proceeds of at least $5 million, and the final one-third
would be payable upon completion by the Company of one or more
financings resulting in aggregate gross proceeds of at least $10 million
(inclusive of the amounts raised in its $8.4 million financing on October 18,
2005 and $3.95 million financing on October 18, 2006). (See Note 7). As of
December 31, 2006, the Company has completed two financings which have totaled
over $10 million.
Accordingly,
on October 18, 2005, upon completion of the private placement, the Company
satisfied one-third of the total indebtedness outstanding under the Note by
making a cash payment of $264,623 and another one-third by issuing to PBI
392,830 shares valued at $0.75 per share, the offering price of the October
2005
private placement, the equivalent of $294,623 of the Company’s common stock.
The
final
one-third of the Note of $264,623, which was due in October 2006, in addition
to
interest of approximately $16,000, remains outstanding and payable to PBI as
of
December 31, 2006. The Company plans to satisfy the final portion of debt and
interest by the end of the first half of 2007.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
The
acquisition of Greenwich on October 18, 2005 was accounted for by the Company
under the purchase method of accounting in accordance with Statement of
Financial Accounting Standards No. 141 “Business Combinations.”
Under
the
purchase method, assets acquired and liabilities assumed by the Company were
recorded at their estimated fair values at the date of acquisition and the
results of operations of the acquired company were consolidated with those
of
the Company from the date of acquisition.
The
total
purchase price of $7,975,218, was determined to be allocable to a charge for
in-process research and development and is comprised of $5,995,077 related
to
the calculated value of the Company’s common stock issued of $0.70 per share
($0.70 per share value was based upon the average stock price of the Company’s
common stock a few days before and a few days subsequent to the July 7, 2005
definitive merger agreement announcement), $986,039 related to the calculated
value of 2,000,000 warrants issued to Greenwich shareholders using the
Black-Scholes option pricing model, $823,869 related to debt the Company assumed
and $170,234 related to professional fees.
The
components of the purchase price, which the Company charged to in-process
research and development, are summarized as follows ($000’s):
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.
The
following unaudited pro forma financial information represents the condensed
consolidated results of operations of the Company and Greenwich for the year
ended December 31, 2005 assuming the acquisition had been consummated at the
beginning of that year. The pro forma information does not necessarily reflect
the results of operations that would have occurred had the entities been a
single company during the year. Our pro forma results of operations are as
follows:
|
|
Pro
Forma (Unaudited)
|
|
|
|
Years
Ended
|
|
|
|
December
31,
|
|
|
|
2005
|
|
NET
LOSS
|
|
$
|
(11,108,786
|
)
|
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
|
$
|
(.38
|
)
|
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING - BASIC AND DILUTED
|
|
|
29,150,897
|
|
The
pro-forma net loss for the year ended December 31, 2005, includes a
non-recurring, one-time charge of $7,975,000 which represents the allocated
in-process research and development costs. The above pro forma financial
information is not necessarily indicative of what the Company’s results of
operations would have been had the Merger occurred on January 1, 2005.
Reincorporation
In
October 2005, the Company, formerly a Minnesota corporation, reincorporated
under Delaware law. The reincorporation was effected by merging the Company
with
and into VioQuest Delaware, Inc., a wholly-owned subsidiary of the Company
formed under Delaware law solely for the purpose of effecting the Company’s
reincorporation, with VioQuest Delaware remaining as the surviving corporation.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
Each
share of outstanding common stock of the Company was converted into one share
of
VioQuest Delaware common stock. In connection with the reincorporation and
merger, VioQuest Delaware’s name was changed to VioQuest Pharmaceuticals, Inc.
Further, as a result of the reincorporation, the Company’s authorized number of
shares was increased to 100,000,000 shares of common stock and 10,000,000 shares
of preferred stock. The Company’s stockholders approved both the reincorporation
and an amendment to the Company’s charter increasing the number of authorized
shares of capital stock at a special meeting held October 8, 2005. The
reincorporation of the Company under Delaware law was a condition to completing
the merger with Greenwich. The par value of the Company’s common stock changed
in October 2005 to $0.001 from $0.01, as a result of the Company’s
reincorporation from Minnesota a par value of $0.01 to Delaware a par value
of
$0.001.
The
cost
of the major classes of property and equipment are as follows:
|
|
December
31, 2006
|
|
December
31, 2005
|
|
Office
equipment
|
|
$
|
27,346
|
|
$
|
18,185
|
|
Computer
equipment
|
|
|
24,123
|
|
|
4,878
|
|
Property
and equipment
|
|
|
51,469
|
|
|
23,063
|
|
Less
accumulated depreciation
|
|
|
8,091
|
|
|
1,787
|
|
Property
and Equipment, Net
|
|
$
|
43,378
|
|
$
|
21,276
|
|
Depreciation
expense for property and equipment for continuing operations for the years
ended
December 31, 2006 and 2005 was $6,304 and $1,646, respectively.
NOTE
6
INCOME
TAXES
The
Company recognized a tax benefit from its discontinued operations of $201,079
and $236,416 for the years ended December 31, 2006 and 2005 as a result of
the
sale of its New Jersey net operating losses (“NOL’s”).
The
significant components of the Company’s net deferred tax assets are summarized
as follows:
|
|
Year
Ended December 31,
|
|
|
|
2006
|
|
2005
|
|
NOL
carryforwards - Federal
|
|
$
|
6,168,321
|
|
$
|
4,110,501
|
|
NOL
carryforwards - State
|
|
|
674,556 |
|
|
365,563 |
|
Tax
credits - State
|
|
|
483,949 |
|
|
- |
|
Inventory
reserve
|
|
|
170,800 |
|
|
- |
|
Employee
stock compensation
|
|
|
416,058 |
|
|
- |
|
Other,
net
|
|
|
114,748 |
|
|
(20,850 |
) |
Valuation
allowance
|
|
|
(8,028,432 |
) |
|
(4,455,214 |
) |
Net
deferred tax assets
|
|
$
|
-
|
|
$
|
-
|
|
Deferred
tax assets have been fully offset by a valuation allowance because it is
management’s belief that it is more likely than not that those benefits will not
be realized.
As
of
December 31, 2006, we had available for federal income tax reporting purposes
NOL carryforwards in the approximate amount of $18,142,000, expiring through
2026, which are available to reduce future earnings that would otherwise be
subject to federal income taxes. Our ability to use such net operating losses
may be limited by change in control provisions under Internal Revenue Code
Section 382. In addition, as of December 31, 2006, we have research and
development credits in the approximate amount of $25,000, which are available
to
reduce the amount of future federal income taxes. These credits expire from
2006
through 2025.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
We
have
New Jersey NOL carryforwards in the approximate amount of $11,243,000 and
research
and development credits in the approximate amount of
$484,000, expiring through 2013 that are available to reduce future earnings,
which would otherwise be subject to state income tax. As of December 31, 2006,
approximately $4,510,000 of these New Jersey NOL carryforwards has been approved
for future sale under a program of the New Jersey Economic Development Authority
(“NJEDA”). In order to realize these benefits, we must apply to the NJEDA each
year and must meet various requirements for continuing eligibility. In addition,
the program must continue to be funded by the State of New Jersey and there
are
limitations based on the level of participation by other companies. As a result,
future tax benefits will be recognized in the financial statements as specific
sales are approved.
The
following is a reconciliation of the expected income tax benefit based on losses
from continuing and discontinued operations before income taxes, computed at
the
U.S. Federal statutory rate to the Company's actual income tax benefit:
|
|
December
31, 2006
|
|
December
31, 2005
|
|
Income
tax benefit at statutory rate
|
|
$
|
(2,880,563
|
)
|
$
|
(4,444,155
|
)
|
State
income taxes net of Federal tax
|
|
|
(417,362
|
)
|
|
(406,665
|
)
|
Nondeductible
expenses and prior year true-up
|
|
|
208,655
|
|
|
100,741
|
|
Nondeductible
in-process research and development
|
|
|
-
|
|
|
3,190,087
|
|
Tax
credits
|
|
|
(483,949
|
)
|
|
(25,177
|
)
|
Sale
of state NOLs
|
|
|
(201,079
|
)
|
|
(236,416
|
)
|
Increase
in valuation allowance
|
|
|
3,573,219
|
|
|
1,585,169
|
|
|
|
$
|
(201,079
|
)
|
$
|
(236,416
|
)
|
On
October 18, 2005, the Company acquired Greenwich Therapeutics, Inc., a privately
held biotechnology company. The acquisition constituted a tax-free
reorganization under Section 368(a) of the Code.
NOTE
7 STOCKHOLDERS'
EQUITY
On
August
29, 2005, the Company issued 200,000 shares of its restricted common stock
to a
consultant at a price of $0.95, the closing price of the Company’s common stock,
which resulted in a charge of $190,000 to consulting expense for 2005.
On
October 18, 2005, the Company sold 11,179,975 Shares of its common stock at
a
price of $0.75 per share resulting in gross proceeds of approximately $8.38
million. In addition to the shares of common stock, the investors also received
5-year Warrants to purchase an aggregate of 4,471,975 shares at an exercise
price of $1.00 per share.
In
connection with the private placement, the Company paid an aggregate of
approximately $587,000 in commissions to Paramount (See Note 11), which served
as the placement agent in connection with the offering, together with an
accountable expense allowance of $50,000, and issued 5-year warrants to purchase
an aggregate of 1,117,997 shares of common stock at a price of $1.00 per share.
Net proceeds to the Company after deducting placement agent fees and other
expenses relating to the private placement, were approximately $7.5
million.
On
October 18, 2005, the Company completed a merger with Greenwich (See Note 4).
In
exchange for Greenwich stockholders’ shares of Greenwich common stock, the
stockholders of Greenwich received an aggregate of 17,128,790 shares of the
Company’s common stock and five-year warrants to purchase an additional
4,000,000 shares of the Company’s common stock at an exercise price of $1.41 per
share. One-half of the securities issued pursuant to the merger agreement were
placed in escrow pursuant to an escrow agreement (See Note 4).
On
October 18, 2006, the Company completed the sales of 7,891,600 shares of its
common stock at a price of $0.50 per share resulting in gross proceeds of
approximately $3.95 million. In connection with the private placement, the
Company engaged Paramount as its exclusive placement agent, and Paramount in
turn engaged various broker-dealers as sub-agents to assist with the offering.
In consideration for their services, we paid an aggregate of approximately
$276,000 in commissions to the placement agents (including sub-agents) in
connection with the offering, of which $56,000 was paid to Paramount, plus
an
additional $30,000 as reimbursement for expenses.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
In
addition to the shares of common stock, we also issued to the investors 5-year
warrants to purchase an aggregate of 2,762,060 shares at an exercise price
of
$0.73 per share. The Company also issued to the placement agents 5-year warrants
to purchase an aggregate of 394,580 shares of common stock at a price of $0.55
per share. Net
proceeds to the Company after deducting placement agent fees and other expenses
relating to the private placement, were approximately $3.65 million. Based
upon
the Black-Scholes stock option pricing valuation model, the investors’ warrants
are estimated to be valued at $1,363,000 and the placement agents’ warrants are
estimated to be valued at approximately $195,000, which have not been recorded
in the financial statements for the year ended December 31, 2006.
The
Company has adopted the 2003 Stock Option Plan (the “Plan”) under which
incentive and non-qualified stock options may be granted. In January 2006,
the
Board approved an amendment to the Plan, increasing the number of common shares
available for grant to 6,500,000 stock options for the purchase of its $0.001
par value of common stock. Grants under the Plan may be made to employees
(including officers), directors, consultants, advisors, or other independent
contractors who provide services to the Company or its subsidiaries.
The
Company issues stock options to employees and non-employees at or above the
fair
market value of its common stock price at the date of grant.
With
the
exception of the immediate vesting of 75,000 stock options granted to a
non-employee director, 50,000 performance-based stock options granted to a
consultant and 40,000 stock options granted to Scientific Advisory Board members
during the year ended December 31, 2006, options granted to employees and
non-employee directors during the year ended December 31, 2006 vest as to 33%
of
the shares on the first, second and third anniversary of the vesting
commencement date.
Following
the vesting periods, options are exercisable until the earlier of 90 days after
the employee’s termination with the Company or the ten-year anniversary of the
initial grant, subject to adjustment under certain conditions.
The
following table summarizes the total number of options outstanding, options
issued to employees, non-employees, directors, consultants, scientific advisory
board members and expired options:
|
|
December
31, 2006
|
|
December
31, 2005
|
|
|
|
|
|
Weighted
|
|
|
|
Weighted
|
|
|
|
|
|
Average
|
|
|
|
Average
|
|
|
|
|
|
Exercise
|
|
|
|
Exercise
|
|
|
|
Shares
|
|
Price
|
|
Shares
|
|
Price
|
|
Outstanding
at beginning of year
|
|
|
4,975,852
|
|
$ |
1.10 |
|
|
2,244,877
|
|
$ |
1.42 |
|
Granted
|
|
|
1,746,580
|
|
$ |
0.75 |
|
|
3,079,475
|
|
$ |
0.90 |
|
Expired
|
|
|
(635,000
|
)
|
$ |
0.89 |
|
|
(348,500
|
)
|
$ |
1.41 |
|
Outstanding
at end of year
|
|
|
6,087,432
|
|
$ |
1.02 |
|
|
4,975,852
|
|
$ |
1.10 |
|
Options
exercisable at year-end
|
|
|
2,670,356
|
|
$ |
1.21 |
|
|
1,170,121
|
|
$ |
1.36 |
|
The
weighted-average fair value of options granted during the year was $0.74 and
$0.86 at December 31, 2006 and 2005, respectively.
The
Company has recorded $1,036,187 related to its employee share-based expenses
in
selling, general and administrative expenses and $3,958 employee share-based
research and development expenses on the accompanying Statements of Operations
for the year ended December 31, 2006. The Company has also recorded $83,523
non-employee share-based expenses related to stock options issued to
consultants. No compensation costs were capitalized as part of the cost of
an
asset.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
The
aggregate intrinsic value for options outstanding and exercisable at December
31, 2006 was $0.00.
The
weighted average remaining contractural term for exercisable and non-exercisable
stock options was 7 years and 8 years respectively as of December 31,
2006.
As
of
December 31, 2006, there was $3,296,453 of total unrecognized compensation
cost
related to nonvested share-based compensation arrangements granted under the
Plan. That cost is expected to be recognized over a weighted average period
of 3
years.
The
following table summarizes the information about stock options outstanding
at
December 31, 2006:
Range
of Exercise Prices
|
|
Outstanding
Options
|
|
Weighted
Average Exercise Price
|
|
|
|
$.01-$0.99
|
|
|
3,889,056 |
|
$
|
0.83
|
|
|
9
|
|
$1.00
- $1.99
|
|
|
2,185,251 |
|
$
|
1.35
|
|
|
7
|
|
$2.00-$2.99
|
|
|
10,000 |
|
$
|
2.17
|
|
|
7
|
|
$3.00-$3.99
|
|
|
875 |
|
$
|
3.20
|
|
|
6
|
|
$4.00-$12.00
|
|
|
2,250 |
|
$
|
7.29
|
|
|
3
|
|
Total
|
|
|
6,087,432 |
|
|
|
|
|
|
|
For
the
purpose of valuing options granted to employees, directors and consultants,
the
Company has valued the options using the Black-Scholes option pricing model
with
the following assumptions used in 2006 and 2005:
|
|
December
31,
2006
|
|
December
31,
2005
|
|
Risk-free
interest rate
|
|
|
4
|
%
|
|
3%-5
|
%
|
Volatility
|
|
|
210%-225
|
%
|
|
108%-175
|
%
|
Lives
in years
|
|
|
7
|
|
|
10
|
|
Dividend
yield
|
|
|
0
|
%
|
|
0
|
%
|
To
determine the risk-free interest rate, the Company utilized the U.S. Treasury
yield curve in effect at the time of grant with a term consistent with the
expected term of the Company’s awards. To determine the stock price volatility,
the Company believes that the volatility calculated over the period since
becoming publicly traded over three years ago, is indicative of what the
volatility would have been had the Company’s stock traded for seven years, the
expected term of its options. In addition, had the Company supplemented the
volatility of its common stock over the past three years with a calculated
volatility from a peer public company or industry sector index, the Company
believes the results would not have produced a more meaningful expectation
of
future volatility. The Company estimated the expected life of the options
granted based on anticipated exercises in future periods. The expected dividends
reflect the Company’s current and expected future policy for dividends on its
common stock. There were no stock options exercised during the years ended
December 31, 2006 and 2005.
As
of
December 31, 2006, an aggregate of 412,568 shares remained available for future
grants and awards under the Company’s stock incentive plan, which covers stock
options and restricted awards. The Company issues unissued shares to satisfy
stock options exercises and restricted stock awards.
The
following table summarizes information related to warrants outstanding at
December 31, 2006:
|
|
Price
|
|
Number
of Outstanding Warrants
|
|
4.75
|
|
$
|
0.73
|
|
|
2,762,060
|
(A)
|
4.75
|
|
$
|
0.55
|
|
|
394,580
|
(B)
|
3.75
|
|
$
|
1.00
|
|
|
5,589,987
|
(C)
|
3.75
|
|
$
|
1.41
|
|
|
4,000,000
|
(D)
|
2.10
|
|
$
|
1.65
|
|
|
2,896,132
|
(E)
|
|
|
|
|
|
|
15,642,759
|
|
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
|
(A)
|
-
Warrants issued as a result of the Company’s private placement of its
common stock in October 2006 to investors. All warrants are exercisable
as
of December 31, 2006.
|
|
(B)
|
-
Warrants issued as a result of the Company’s private placement of its
common stock in October 2006 to placement agents. All warrants are
exercisable as of December 31,
2006.
|
|
(C)
|
-
Warrants issued as a result of the Company’s private placement of its
common stock in October 2005 to investors and placement agents. All
warrants are exercisable as of December 31,
2006.
|
|
(D)
|
-
Warrants issued as a result of the merger with Greenwich. In connection
with the escrow agreement (see Note 4), one-half of the warrants
are
exercisable upon the achievement of certain clinical milestones.
Half of
the warrants are exercisable as of December 31,
2006.
|
|
(E)
|
-
Warrants issued as a result of the Company’s private placement of its
common stock in February 2004 to investors and placement agents.
All
warrants are exercisable as of December 31,
2006.
|
NOTE
8 COMMITMENTS
AND CONTINGENCIES
(A)
EMPLOYMENT AGREEMENT WITH CEO
The
Company entered into a written employment agreement dated as of February 1,
2005
with Daniel Greenleaf upon his appointment as the Company’s President and Chief
Executive Officer. The agreement provides for a 3-year term and an initial
annual base salary of $360,000, plus a guaranteed annual bonus of $100,000
during each year of the term of the agreement. In addition, Mr. Greenleaf is
entitled to a signing bonus in the amount of $50,000, of which one-half was
paid
following the execution of the employment agreement and the remaining one-half
was paid on the 6-month anniversary of the agreement. Mr. Greenleaf is further
entitled to a discretionary bonus under the employment agreement of up to
$250,000 per year upon the attainment of certain performance criteria specified
in the employment agreement, and such other benefits generally made available
to
the Company’s other senior management.
In
accordance with the terms of the employment agreement, the Company issued to
Mr.
Greenleaf an option to purchase 891,396 shares of the Company’s common stock,
which represented 5% of the Company’s then-current outstanding common stock. The
option vests in three equal annual installments, commencing February 2006.
In
addition, until the Company has raised $20 million through the sale of equity
securities and has obtained the rights to one clinical stage human therapeutic,
Mr. Greenleaf shall be entitled to receive such additional options to purchase
common stock in order to maintain his beneficial ownership (assuming the
exercise of all stock options issued to Mr. Greenleaf) at 5% of the Company’s
outstanding common stock. To the extent any additional stock options are issued
pursuant to the foregoing sentence, the options will vest in installments over
the term of the employment agreement as long as Mr. Greenleaf remains employed
by the Company and will be exercisable at the market value of the Company’s
common stock at the time of issuance. In accordance with this provision, upon
the closing of the Company’s October 2005 private placement, the Company issued
to Mr. Greenleaf an additional option to purchase 1,445,080 shares of common
stock at an exercise price of $0.89 per share, and upon the closing of the
Company’s October 2006 private placement, the Company issued to Mr. Greenleaf an
additional option to purchase 394,580 shares of common stock at an exercise
price of $0.56 per share, one-half of which vested February 1, 2007 and the
remainder will vest on February 1, 2008. In the event Mr. Greenleaf’s employment
is terminated by the Company during its term upon a “change of control” (as
defined in the employment agreement) and on the date of such termination the
Company’s aggregate market capitalization is less than $38 million, he is
entitled to receive his base salary for six months thereafter and all of his
stock options scheduled to vest in the calendar year of such termination shall
accelerate and be deemed vested upon termination and will remain exercisable
for
12 months following such termination.
In
the
event the Company terminates Mr. Greenleaf’s employment during the term of the
agreement other than as a result of death, disability, cause or in connection
with a change of control where the Company’s aggregate market capitalization is
less than $38 million, then (i) Mr. Greenleaf is entitled to receive his base
salary for 12 months from such termination, his guaranteed bonus for the
calendar year in which such termination occurs, and the portion of any
discretionary bonus earned as of the termination, and (ii) the vesting of his
stock options shall accelerate and be deemed vested and will remain exercisable
for 12 months following such termination.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
(B)
LEASE AGREEMENTS
The
Company leases office space for its corporate headquarters in Basking Ridge,
New
Jersey. Effective November 2006, the Company amended its original June 2005,
lease agreement. The lease requires monthly payments of approximately $8,000
and
expires in January 2012.
The
Company leases laboratory and office space for its discontinued Chiral Quest
operation located in Monmouth Junction, New Jersey. In January 2006, the Company
amended its original lease agreement to extend its lease term to May 31, 2009.
Effective June 1, 2006, the Company’s base rent for the remainder of the term is
$19,439 per month. Upon six months prior written notice to the landlord, the
Company will have a one time option, without penalty, to terminate this lease
effective as of May 31, 2008. The lease requires monthly payments of
approximately $28,000 which includes rent, utilities and maintenance fees,
and
expires in May 31, 2009.
The
Company’s leases laboratory and office space for its discontinued Chiral Quest
operation with
the
Science and Technology Bureau of Jiashan County (“Jiashan”) in Zhejiang Province
of the People’s Republic of China. .
The
Company has entered into an agreement effective December 15, 2004 at an
industrial park near Shanghai, 50% of which the Company began occupying in
2005.
Pursuant to the Company’s agreement with Jiashan, although the Company is not
required to pay rent during the initial 3-years of the lease, the Company will
pay a maintenance fee of up to $4,500 per quarter, which is comprised of
maintenance and management fees. Following the initial 3-year term, the Company
may, at our sole discretion, either continue leasing the space for annual rent
of no more than $60,000 or purchase the facility on commercially reasonable
terms. The Company has no financial obligation pursuant to the lease agreement
after the end of the three year term. The Company was also granted the option
to
purchase in the next three years certain land adjacent to the industrial park.
For purposes of entering into the lease, the Company established a wholly owned
subsidiary organized under the laws of Hong Kong, known as Chiral Quest Ltd.,
which in turn is the sole shareholder of a subsidiary in the People’s Republic
of China, Chiral Quest (Jiashan) Ltd.
Future
minimum rental payments subsequent to December 31, 2006 for operations are
as
follows:
Years
ended December
31,
|
|
Continuing
Operations
|
|
Discontinued
Operations
|
|
Total
|
|
2007
|
|
$
|
97,000
|
|
|
331,000
|
|
|
428,000
|
|
2008
|
|
|
97,000
|
|
|
331,000
|
|
|
428,000
|
|
2009
|
|
|
97,000
|
|
|
137,000
|
|
|
234,000
|
|
2010
|
|
|
101,000
|
|
|
|
|
|
101,000
|
|
2011
|
|
|
102,000
|
|
|
|
|
|
102,000
|
|
Total
|
|
$
|
494,000
|
|
|
799,000
|
|
|
1,293,000
|
|
Total
rent expense for the continuing operations of the Company, which includes base
rent, and utilities, for Basking Ridge, New Jersey for the years ended December
31, 2006 and 2005 was approximately $50,000 and $18,000, respectively.
NOTE
9
INTELLECTUAL
PROPERTY AND LICENSE AGREEMENTS
License
with The Cleveland Clinic Foundation (“CCF”). We
have
an exclusive, worldwide license agreement with CCF for the rights to develop,
manufacture, use, commercialize, lease, sell and/or sublicense VQD-001. We
are
obligated to make an annual license maintenance payment until the first
commercial sale of VQD-001, at which time we are no longer obligated to pay
this
maintenance fee. In addition, the license agreement requires us to make payments
in an aggregate amount of up to $4.5 million to CCF upon the achievement of
certain clinical and regulatory milestones. Should VQD-001 become
commercialized, we will be obligated to pay CCF an annual royalty based on
net
sales of the product. In the event that we sublicense VQD-001 to a third party,
we will be obligated to pay CCF a portion of fees and royalties received from
the sublicense. We hold the exclusive right to negotiate for a license on any
improvements to VQD-001 and have the obligation to use all commercially
reasonable efforts to bring VQD-001 to market. We
have
agreed to prosecute and maintain the patents associated with VQD-001 or
provide notice to CCF so that it may so elect. The license agreement may be
terminated by CCF, upon notice with an opportunity for cure, for our failure
to
make required payments or its material breach, or by us, upon thirty day’s
written notice.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
License
with the University of South Florida Research Foundation,
Inc.(“USF”)
We have
an exclusive, worldwide license agreement with USF for the rights to develop,
manufacture, use, commercialize, lease, sell and/or sublicense VQD-002. Under
the terms of the license agreement, we have agreed to sponsor research involving
VQD-002 annually for the term of the license agreement. In addition, the
license agreement requires us to make payments in an aggregate amount of up
to
$5.8 million to USF upon the achievement of certain clinical and regulatory
milestones. Should a product incorporating VQD-002 be commercialized, we are
obligated to pay to USF an annual royalty based on net sales of the product.
In
the event that we sublicense VQD-002 to a third party, we are obligated to
pay
USF a portion of fees and royalties received from the sublicense. We hold a
right of first refusal to obtain an exclusive license on any improvements to
VQD-002 and have the obligation to use all commercially reasonable efforts
to
bring VQD-002 to market. We have agreed to prosecute and maintain the patents
associated with VQD-002 or provide notice to USF so that it may so elect. The
license agreement shall automatically terminate upon Greenwich’s bankruptcy or
upon the date of the last to expire claim contained in the patents subject
to
the license agreement. The license agreement may be terminated by USF, upon
notice with an opportunity for cure, for our failure to make required payments
or its material breach, or by us, upon six month’s written notice.
NOTE
10 RETIREMENT
PLAN
The
Company sponsors a defined contribution 401(k) plan which allows eligible
employees to defer a portion of their salaries for retirement planning and
income tax purposes by making contributions to the plan. There were no Company
contributions to the plan for the years ended December 31, 2006 and 2005.
NOTE
11 CERTAIN
TRANSACTIONS
On
October 18, 2005, the Company completed the sales of 11,179,975 of its common
stock at a price of $0.75 per share resulting in gross proceeds of approximately
$8.38 million. In addition to the shares of common stock, the investors also
received 5-year warrants to purchase an aggregate of 4,471,975 shares at an
exercise price of $1.00 per share. In connection with the private placement,
we
paid an aggregate of approximately $587,000 in commissions to Paramount.
Paramount served as the placement agent in connection with the offering,
together with an accountable expense allowance of $50,000, and we issued 5-year
warrants to purchase an aggregate of 1,117,997 shares of common stock at a
price
of $1.00 per share. Net proceeds to us after deducting placement agent fees
and
other expenses relating to the private placement were approximately $7.5
million.
On
October 18, 2005, the Company completed a merger with Greenwich (See Note 4).
In
exchange for Greenwich stockholders’ shares of Greenwich common stock, the
stockholders of Greenwich received an aggregate of 17,128,790 shares of the
Company’s common stock and five-year warrants to purchase an additional
4,000,000 shares of the Company’s common stock at an exercise price of $1.41 per
share. One-half of the securities issued pursuant to the merger agreement were
placed in escrow pursuant to an escrow agreement (see Note 4). Additionally,
as contemplated by the merger Agreement with Greenwich (see Note 4), on October
18, 2005, the Company assumed outstanding indebtedness of Greenwich of $823,869,
all of which was owed to Paramount BioSciences, LLC. (“PBS”), an affiliate of
Paramount, pursuant to a promissory note dated October 17, 2005 (the “Note”).
At
the
closing of the merger, the Note was amended to provide that one-third would
be
converted into securities of the Company on the same terms as the Company’s
October 2005 private placement, one-third of the outstanding indebtedness under
the Note would be repaid upon the completion by the Company of a financing
resulting in gross proceeds of at least $5 million, and the final one-third
would be payable upon completion by the Company of one or more financings
resulting in aggregate gross proceeds of at least $10 million (inclusive of
the
amounts raised in a previous $5 million financing).
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2006 AND 2005
Accordingly,
on October 18, 2005, upon completion of the private placement, the Company
satisfied one-third of the total indebtedness outstanding under the Note by
making a cash payment of $264,623 and another one-third by issuing to PBS
392,830 shares valued at $0.75 the offering price of October 2005 private
placement, the equivalent of $294,623 of the Company’s common stock. The final
one-third of the Note of $264,623, in addition to accrued interest of
approximately $16,000 as of December 31, 2006, which was originally due to
be
paid in October 2006, however, remains outstanding and payable to PBS as of
December 31, 2006. The Company plans to satisfy the final portion of debt and
accrued interest by the end of the first half of 2007. Dr. Lindsay A. Rosenwald
and certain trusts established for the benefit of Dr. Rosenwald and his family
collectively held approximately 48% of Greenwich’s capital stock prior to the
Company’s acquisition of Greenwich. Together, Dr. Rosenwald and such trusts also
owned approximately 16% of the Company’s common stock prior to the completion of
the Merger. In addition to Dr. Rosenwald’s relationship with Greenwich, two
directors of the Company, Stephen C. Rocamboli and Michael Weiser, M.D., Ph.D.,
owned approximately 3.6% and 7% respectively, of Greenwich’s outstanding common
stock. Mr. Rocamboli is currently employed by Paramount and, until December
2006, Dr. Weiser was employed by Paramount of which Dr. Rosenwald is the
chairman and sole stockholder, and is also a substantial stockholder of the
Company.
In
August
2006, the Company entered into a consulting agreement for a period of three
months at $30,000 per month, with Paramount Corporate Development, an affiliate
of Paramount, to provide a strategic and technical assessment for all of the
Company’s clinical development programs.
On
October 18, 2006, the Company completed the sales of 7,891,600 shares of its
common stock at a price of $0.50 per share resulting in gross proceeds of
approximately $3.95 million. In connection with the private placement, the
Company engaged Paramount as its exclusive placement agent, and Paramount in
turn engaged various broker-dealers as sub-agents to assist with the offering.
In consideration for their services, we paid an aggregate of approximately
$276,000 in commissions to the placement agents (including sub-agents) in
connection with the offering, of which $56,000 was paid to Paramount, plus
an
additional $30,000 as reimbursement for expenses.
In
addition to the shares of common stock, we also issued to the investors 5-year
warrants to purchase an aggregate of 2,762,060 shares at an exercise price
of
$0.73 per share. The Company also issued to the placement agents 5-year warrants
to purchase an aggregate of 394,580 shares of common stock at a price of $0.55
per share. Net
proceeds to the Company after deducting placement agent fees and other expenses
relating to the private placement, were approximately $3.65 million.
Based
upon the Black- Scholes option pricing valuation model, the investor warrants
are estimated to be valued at approximately $1,363,000, which is derived from
their exercise price of $0.73 per share, a fair market value of $0.50 per share
as of October 18, 2006, a 5 year term, with a 4.73% risk free interest rate.
However, the Company was not required to record that value for accounting
purposes.
NOTE
12 SUBSEQUENT
EVENTS
On
February 1, 2007, the Company appointed Edward C. Bradley, M.D., as its Chief
Scientific and Medical Officer. Dr. Bradley’s employment with the Company is
governed by the terms of a letter agreement dated January 31, 2007, and provides
for an initial base salary of $330,000 plus an annual target bonus of up to
20%
of his base salary based upon personal performance and an additional amount
of
up to 10% of his base salary based upon Company performance. Pursuant to the
letter agreement, Dr. Bradley also received an option to purchase 700,000 shares
of the Company’s common stock. The option will vest in three equal annual
installments, commencing in February 2008 and will be exercisable at a price
per
share equal to $0.55. The option was issued pursuant to the Company’s 2003 Stock
Option Plan and will be exercisable by Dr. Bradley as long as he remains
employed by the Company; provided, however, if the Company completes a
transaction in which it sells its assets or stock resulting in a change of
control of the Company (other than a sale of the stock or assets of the
Company’s Chiral Quest subsidiary) during Dr. Bradley’s employment, the vesting
of the stock option shall accelerate and be deemed vested. In the event that
the
Company terminates Dr. Bradley’s employment without cause, Dr. Bradley is
entitled to receive his then annualized base salary for a period of six months.
If Dr. Bradley’s employment is terminated without cause and within a year of a
change of control, as described above, then Dr. Bradley is entitled to receive
his then annualized base salary for a period of one year, and he is entitled
to
receive any bonuses he has earned at the time of his termination.
Exhibit
No.
|
|
Description
|
10.15
|
|
Form
of Stock Option Agreement for use under the 2003 Stock Option
Plan.
|
|
|
|
21.1
|
|
Subsidiaries
of the Registrant
|
|
|
|
23.1
|
|
Consent
of J.H. Cohn LLP.
|
|
|
|
31.1
|
|
Certification
of Chief Executive Officer.
|
|
|
|
31.2
|
|
Certification
of Chief Financial Officer.
|
|
|
|
32.1
|
|
Certification
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.2
|
|
Certification
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|