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,
2007
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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, 2007, the issuer had $0 revenue from continuing
operations and, together with its discontinued operations; the issuer had total
revenue of $1,484,584.
The
aggregate market value of the issuer’s common stock held by non-affiliates as of
March 27, 2008, based on the closing price of the common stock as reported
on
the OTC Bulletin Board on such date, was $2,661,823.
As
of
March 27, 2008 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 2008 Annual Meeting of
Stockholders (the “2008 Proxy Statement”) are incorporated by reference into
Part III of this Form 10-KSB, to the extent described in Part III. The 2008
Proxy Statement will be filed within 120 days after the fiscal year ended
December 31, 2007.
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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Description
of Property
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21
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Item
3
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Legal
Proceedings
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22
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Item
4
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Submission
of Matters to a Vote of Security Holders
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22
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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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23
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Item
6
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Management’s
Discussion and Analysis or Plan of Operations
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24
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Item
7
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Consolidated
Financial Statements
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35
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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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35
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Item
8A(T)
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Controls
and Procedures
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35
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Item
8B
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Other
Information
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35
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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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36
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Item
10
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Executive
Compensation
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36
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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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36
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Item
12
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Certain
Relationships and Related Transactions
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36
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Item
13
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Exhibit
List
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36
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Item
14
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Principal
Accountant Fees and Services
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38
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39
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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.
Xyfid™
is
our trademark for 1% uracil topical that we are developing for the treatment
of
Hand-Foot syndrome caused by certain chemotherapy agents. Lenocta™ is our
trademark for our sodium stibogluconate product candidate. All other trademarks
and trade names mentioned in this Annual Report are the property of their
respective owners.
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
We
are a
biopharmaceutical company focused on the acquisition, development and
commercialization of clinical stage drug therapies targeting both the molecular
basis of cancer and side effects of cancer treatment. Our lead compound under
development is Xyfid (1% topical uracil) for the treatment and prevention of
Hand-Foot Syndrome (“HFS”), a common and serious side effect of chemotherapy
treatments. In parallel, Xyfid is also being developed to treat dry skin
conditions and manage the burning and itching associated with various diseases
of the skin, or dermatoses. We expect to initiate a Phase IIb program for Xyfid
in 2008 for HFS, and are exploring a parallel 510(k) Premarket Notification
submission during 2008 for Xyfid to treat various dermatoses. Additionally,
we
are developing VQD-002 (triciribine phosphate monohydrate or TCN-P), a small
molecule anticancer compound that inhibits activation of protein kinase B (PKB
or AKT), a key component of a signaling pathway known to promote cancer cell
growth and survival as well as resistance to chemotherapy and radiotherapy.
VQD-002 is currently in Phase I clinical development for multiple tumor types
and we expect to advance VQD-002 into Phase II clinical development during
2008.
We are also developing Lenocta (sodium stibogluconate), which we previously
referred to as VQD-001, a selective, small molecule inhibitor of certain protein
tyrosine phosphatases (“PTPs”), such as SHP-1, SHP-2 and PTP1B, with
demonstrated anti-tumor activity against a wide spectrum of cancers both alone
and in combination with other approved immune activation agents, including
IL-2
and interferons. Lenocta is currently in a Phase IIa clinical trial as a
potential treatment for melanoma, renal cell carcinoma, and other solid tumors.
In addition to its potential role as a cancer therapeutic, sodium stibogluconate
has been approved in most of the world for first-line treatment of
leishmaniasis, an infection typically found in tropic and sub-tropic developing
countries. Based on historical published data and a large observational study
by
the U.S. Army, data from approximately 400 patients could be utilized to support
a New Drug Application (“NDA”) with the U.S. Food and Drug Administration
(“FDA”) in 2008. Lenocta has been granted Orphan Drug status for leishmaniasis.
To date, we have not received approval for the sale of any of our drug
candidates in any market and, therefore, have not generated any product sales
from our drug candidates.
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 to Chiral Quest, Inc. In August 2004, we then changed our name
to
VioQuest Pharmaceuticals, Inc. and formed Chiral Quest, Inc. as our wholly-owned
subsidiary. In October 2005, we reincorporated under Delaware law by merging
into a wholly-owned subsidiary VioQuest Delaware, Inc., incorporated under
Delaware law as the surviving corporation and our wholly-owned subsidiary.
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 our wholly-owned subsidiary VioQuest
Delaware, Inc. 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 - Lenocta, and
VQD-002.
In
July
2007, the Company sold all of its shares of capital stock of its Chiral Quest
subsidiary. Chiral Quest provided innovative chiral products, technology and
custom synthesis services to pharmaceutical and final chemical companies in
all
stages of a products’ life cycle.
STRATEGY
OF PRODUCTS UNDER DEVELOPMENT
Through
our drug development business, we acquire, develop, and intend to commercialize
novel drug therapies targeting both the molecular basis of cancer and side
effects of treatment. Through our acquisition of Greenwich Therapeutics, Inc.
in
October 2005, we obtained the rights to develop and commercialize two oncology
drug candidates - Lenocta and VQD-002. We hold our rights to Lenocta and
VQD-002, pursuant to license agreements with The Cleveland Clinic Foundation
and
the University of South Florida Research Foundation, respectively. In March
2007, the Company acquired license rights to develop and commercialize Xyfid.
The Company’s rights to Xyfid are governed by a license agreement with
Asymmetric Therapeutics, LLC and Onc Res, Inc., as assigned to the Company
by
Fiordland Pharmaceuticals, Inc. These licenses give us the right to develop,
manufacture, use, commercialize, lease, sell and/or sublicense Lenocta, VQD-002
and Xyfid.
Xyfid
(1% uracil topical)
Overview
VioQuest
has been developing Xyfid for the treatment and prevention of palmar-plantar
erythrodysesthesia (PPE), also known as hand-foot syndrome (HFS), a relatively
common dose-limiting side effect of cytotoxic chemotherapy - most frequently
fluoropyrimidines, such as continuous infusion 5-fluorouracil (5-FU), and the
oral 5-FU prodrug capecitabine (Xeloda® by Roche). Fluoropyrimidines are among
the most commonly used cancer chemotherapeutics nearly 50 years after their
introduction. Fluoropyrimidines, alone or in combination therapy, are commonly
given for cancers of the head and neck, breast, cervix, and gastrointestinal
tract.
There
are
currently no treatments or preventative agents for HFS, which is characterized
by the progressive redness and cracking of the hands and feet. The severity
of
HFS is typically defined by three grade levels: Grade 1: numbness, tingling,
painless swelling; Grade 2: painful discomfort, swelling; Grade 3: ulceration,
blistering, severe pain and discomfort, unable to work or perform activities
of
daily living. Up to 60% of all capecitabine patients experience HFS and up
to
20% experience severe HFS (Grade 3). According to the prescribing information
for capecitabine, if grade 2 or 3 HFS occurs, administration of capecitabine
should be interrupted until the event resolves or decreases in intensity to
grade 1. Following grade 3 HFS, subsequent doses of capecitabine should be
decreased.
Uracil,
the active ingredient in Xyfid, is a naturally occurring substrate for enzymes,
such as thymidine phosphorylase (TP) and and dihydropyrimidine dehydrogenase
(DPD), that metabolize fluoropyrimidines into toxic metabolites. Addition of
uracil to systemic fluoropyrimidine treatment regimens, such as tegafur-uracil,
or UFT, is well-established to significantly diminish the incidence of
HFS. Whereas
such combination products have been licensed in Japan and much of Europe, they
have not been approved for use in the United States due, in part, to FDA
questions regarding the demonstrable non-inferiority of the combination drug
compared with fluoropyrimidines
alone.
In
contrast to systemic exposure, topical application of uracil would potentially
allow for the treatment and prevention of HFS without compromising the efficacy
of systemic fluoropyrimidine
therapy.
In a small pilot study, Xyfid has been effective at preventing the both the
incidence and recurrence of dose limiting HFS when applied topically.
Clinical
and Regulatory Development
VioQuest
is considering parallel regulatory paths for two separate indications for
Xyfid:
510(k)
Premarket Notification
During
March 2008, we signed an agreement with Medical Device Consultants, Inc. (MDCI)
for MDCI to assist us in obtaining clearance to market Xyfid pursuant to Section
510(k) of the Food, Drug and Cosmetic Act, or FDCA, and in particular, the
“premarket notification” provisions of Section 510(k). To qualify for 510(k)
premarket notification, a product must be substantially equivalent to another
device that is legally marketed in the U.S. A device is substantially equivalent
if, in comparison to a predicate it:
•
has
the
same intended use as the predicate; and
•
has
the
same technological characteristics as the predicate;
A
claim
of substantial equivalence does not mean the new and predicate devices must
be
identical. Substantial equivalence is established with respect to intended
use,
design, energy used or delivered, materials, chemical composition, manufacturing
process, performance, safety, effectiveness, labeling, biocompatibility,
standards, and other characteristics, as applicable.
We
believe that Xyfid may be substantially equivalent to several predicate devices
designed to improve dry skin conditions and to relieve and to manage the burning
and itching associated with various dermatoses including atopic dermatitis,
irritant contact dermatitis, radiation dermatitis and other dry skin conditions,
by maintaining a moist wound and skin environment. Substantial equivalence
for
Xyfid may be supported by the fact that chemically, uracil looks like a fusion
of urea and malonic acid, which are both common ingredients found in many
topical creams. Urea creams, such as Aquacare® and Carmol® are used for
moisturizing and softening dry, cracked, calloused, rough, and hardened skin
of
feet, hands, or elbows.
Since
uracil is known to decompose to urea and malonic acid, we believe that Xyfid
could be considered a sustained-release version of urea, helping trap water
and
creating a healing “moisture barrier.” Xyfid applied at least twice daily to
affected areas of the skin could improve dry skin conditions and relieve and
manage the burning and itching associated with various dermatoses, including
atopic dermatitis, irritant contact dermatitis, radiation dermatitis and other
dry skin conditions by maintaining a moist wound and skin
environment.
New
Drug Application (NDA) Process
A
pilot
clinical study in patients has demonstrated that topical application of Xyfid
to
the hands and feet may be effective in preventing the recurrence of dose
limiting HFS. On this basis, an investigational new drug application (IND)
was
submitted and accepted by the FDA. Subsequently, Xyfid was granted fast track
designation for the prevention of HFS in patients receiving capecitabine for
the
treatment of advanced metastatic breast cancer.
Pursuant
to this IND, we expect to evaluate the safety, tolerability and activity of
Xyfid and its ability to reduce the incidence of HFS. We are considering a
30-patient Phase IIb study in breast cancer patients receiving capecitabine
that
could begin during 2008. The outcome of the Phase IIb study could support plans
for registration of Xyfid under the NDA process. Xyfid has been awarded
fast-track status by the FDA in this setting.
VQD-002
(triciribine phosphate monohydrate)
Overview
VQD-002,
a tricyclic nucleoside that inhibits the activation of Akt, has demonstrated
anti-tumor activity against a wide spectrum of cancers in preclinical and
clinical studies. Amplification, overexpression, or activation of Akt, also
named protein kinase B, have been detected in a number of human malignancies,
including prostate, breast, ovarian, colorectal, pancreatic, and hematologic
cancers. Activation of Akt is associated with cell survival, malignant
transformation, tumor invasiveness, and chemo-resistance, while inhibition
of
Akt activity has been shown to cause cell death. These attributes make Akt
an
attractive target for cancer therapy.
Pre-Clinical
and Clinical Data
VQD-002
was first synthesized in 1971 and identified as an antineoplastic agent. Phase
I
clinical trials on VQD-002 proved that its safety and side effects were dose
dependent. However, as a single drug in Phase II trials, VQD-002 failed to
show
efficacy against advanced breast, colon, and lung cancer even at very high
doses.
A
few
years ago, researchers at Moffitt Cancer Center found that VQD-002 inhibits
Akt
activation and has antitumor activity as a single agent against tumors with
activated Akt. Inhibition of Akt activation plays a key role in VQD-002’s
antitumor activity. Thus, Phase I trials of VQD-002 have been initiated for
tumors with activated Akt using much lower doses of VQD-002 than those
previously used that caused toxicity.
During
October 2007, preclinical study results were published demonstrating that
combining VQD-002 with trastuzumab (Herceptin® by Genentech) may be a clinically
applicable strategy to overcome trastuzumab resistance, particularly that caused
by loss of PTEN, a tumor suppressor protein. Trastuzumab resistance is a
clinically devastating problem and this study suggests a rational improvement
to
trastuzumab-based therapy, which could directly affect the clinical management
of breast cancer patients in general and particularly those with PTEN-deficient
tumors.
During
January 2008, preclinical study results were published demonstrating that
VQD-002 disrupts a specific signaling pathway associated with chemoresistance
and cancer cell survival in ovarian cancer. The preclinical study results
indicate that VQD-002 could play a role in reversing drug resistance in ovarian
cancer for patients treated with chemotherapy in the years ahead.
In
a
preliminary Phase I solid tumor study, patients with progressive disease despite
receiving a median of 3 prior treatment regimens (range 1-4), VQD-002 was
administered intravenously over a 28-day cycle on days 1, 8, and 15. Cohorts
of
3 patients received escalating doses of VQD-002 at 15, 25, 35, and 45 mg/m2.
Enrollment to higher doses is ongoing, which we are currently at 55 mg/m2.
Preliminary Phase I data from this solid tumor study demonstrated that VQD-002
was well tolerated; one melanoma subject had stable disease for 8 months.
Interim
results of a Phase I trial in hematologic malignancies demonstrate that VQD-002
is well-tolerated and shows signs of clinical activity in patients with advanced
leukemias. The Phase I trial is designed to assess the safety, tolerability
and
pharmacokinetics of VQD-002 and to establish a recommended Phase II dose for
further studies among patients. In results presented to date, a total of 28
patients have been enrolled at two clinical sites. Eighteen patients are
evaluable for toxicity and response, eight patients are evaluable for toxicity
only, and two patients are not evaluable.
Preliminary
results from this trial show that patients with relapsed, refractory acute
myeloid leukemia, or AML, experienced a decrease in peripheral blood
myeloblasts, a measure of clinical activity. In particular, four patients
treated at the 25 mg/m2 or 35 mg/m2 dose level of VQD-002 experienced up to
50
percent reductions in peripheral blast cells. Additional hematological
improvements included two patients achieving major improvements in platelet
count lasting 7 and 36 days, respectively, and four patients achieving major
improvements in neutrophil count lasting a median of 19 days while on therapy.
VQD-002 was well-tolerated at the doses studied.
Development
Status
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 in two Phase I clinical trials, including one at the Moffitt
Cancer Center in up to 42 patients with hyper-activated, phosphorylated Akt
in
solid tumors and a second clinical trial, with up to 40 patients, at the M.D.
Anderson Cancer Center and the Moffitt Cancer Center in hematological tumors,
with particular attention in leukemias. We expect to complete our Phase I
studies in 2008. During 2008, the FDA granted orphan drug designation to VQD-002
for the treatment of multiple myeloma. We expect to advance VQD-002 into Phase
II clinical development during 2008.
Lenocta
(sodium stibogluconate)
Overview
Lenocta
is a selective, small molecule inhibitor of certain protein tyrosine
phosphatases (PTPs), such as SHP-1, SHP-2 and PTP1B, with demonstrated
anti-tumor activity against a wide spectrum of cancers both alone and in
combination with other approved immune activation agents, including IL-2 and
interferons. PTPs are a family of proteins that regulate signal transduction
pathways in cells and have been implicated in a number of diseases including
cancer, diabetes, and neurodegeneration.
Pre-Clinical
and Clinical Data
Lenocta
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 Lenocta 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 Lenocta
may be useful to treat certain other tumor types, including prostate
cancer.
The
preclinical data suggests that Lenocta 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 Lenocta’s
known historical toxicity profile, demonstrate that Lenocta is a potentially
attractive drug candidate to evaluate as an anti-cancer agent.
Phase
I
data from our combination trial of Lenocta
and alpha
interferon (“IFN a-2b”)
demonstrated pharmacodynamic activity in some solid tumors as demonstrated
by
increases in the activities of natural killer cells, CD8 and type II dendritic
cells, and two patients with ocular melanoma (1) and adenocystic carcinoma
(1)
have remained stable by Response Evaluation Criteria in Solid Tumors, or RECIST,
on first assessment. There have been seventeen subjects evaluable for
response.
A
complete treatment cycle is for six weeks, with week 1 the patient is
intravenously dosed with Lenocta for five days as a monotherapy, week 2 the
patient is dosed with Lenocta
and IFN
a-2b,
week
3 is a rest period, weeks 4 and 5 the patient is dosed with Lenocta
and IFN
a-2b,
and
then there is a week rest before a subsequent cycle is initiated. Patients
have
been given four different dose cohorts: 400 mg/m2, 600 mg/m2, 900 mg/m2 and
1350
mg/m2. Lenocta with IFN a-2b
has
been well tolerated at doses up to 900 mg/m2.
Development
Status
We
filed
with the FDA an IND for Lenocta, which the FDA accepted in August 2006, allowing
us to commence clinical trials of Lenocta.
Lenocta
is currently being studied at the M.D. Anderson Cancer Center and the University
of New Mexico in a Phase IIa corporate-sponsored clinical trial in combination
with IFN a-2b
in up
to 54-patients with melanoma, renal cell carcinoma, and other solid tumors
that
have been non-responsive in previous cytokine therapy. In November 2007, we
dosed our first patient in our Phase IIa solid tumor study. We expect to
complete enrollment in our Phase IIa solid tumor study in 2008. The Phase IIa
trial has been designed to evaluate the clinical efficacy and biological
effectiveness of Lenocta at the highest tolerable does in combination with
IFN
a-2b
in
patients with advanced-stage solid tumors.
The
primary objectives of the Phase IIa clinical trial is to evaluate the tolerance,
safety, maximum tolerated dose, and clinical efficacy and biological
effectiveness of Lenocta in combination with IFN a-2b.
In
addition, this trial will also evaluate pharmacokinetic data and anti-neoplastic
activity. We also hope to gain a better understanding of how Lenocta affects
important biological and genetic pathways.
Additional
Potential Indication of Lenocta
As
we
continue to develop Lenocta for indications primarily used for an oncology
drug
candidate, we are also in the process of evaluating its potential development
as
a treatment for leishmaniasis. 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:
· |
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;
|
· |
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
|
· |
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.
|
In
collaboration with the U.S. Army through an executed CRADA, we are evaluating
the potential development of Lenocta in the treatment of leishmaniasis. Lenocta
was granted orphan drug designation by the FDA in the second half of 2006 for
the treatment of leishmaniasis. The Company has also convened an advisory board
to evaluate the potential submission of an NDA to the FDA for Lenocta for the
treatment of leishmaniasis in 2008.
COMPETITION
Competition
in the pharmaceutical and biotechnology industries is intense. Our competitors
include pharmaceutical companies and biotechnology companies, as well as
universities and public and private research institutions. In addition,
companies that are active in different but related fields represent substantial
competition for us. Many of our competitors have significantly greater capital
resources, larger research and development staffs and facilities and greater
experience in drug development, regulation, manufacturing and marketing than
we
do. These organizations also compete with us to recruit qualified personnel,
attract partners for joint ventures or other collaborations, and license
technologies that are competitive with ours. To compete successfully in this
industry we must identify novel and unique drugs or methods of treatment and
then complete the development of those drugs as treatments in advance of our
competitors.
The
drugs
that we are attempting to develop will have to compete with existing therapies.
In addition, a large number of companies are pursuing the development of
pharmaceuticals that target the same diseases and conditions that we are
targeting. Other companies have products or drug candidates in various stages
of
pre-clinical or clinical development to treat diseases for which we are also
seeking to discover and develop drug candidates. Some of these potential
competing drugs are further advanced in development than our drug candidates
and
may be commercialized earlier.
SUPPLY
AND MANUFACTURING
We
have
limited experience in manufacturing products for clinical or commercial
purposes. We have entered into an agreement with Patheon Inc., a leading global
provider of drug development and manufacturing services to the international
pharmaceutical industry, to manufacture Xyfid which we believe will be adequate
to satisfy our current clinical trial and early commercial market needs.
As
we
move forward, we plan to secure additional manufacturing capacity to meet the
future demands for Xyfid and create back-up manufacturing capabilities.
The
creation of a reproducible process is also critical in successfully sourcing
Xyfid from multiple suppliers to create back-up manufacturing capabilities
and/or to meet market demand. We believe that multi-sourcing is possible
provided we can demonstrate that the manufacturing process is the same at all
suppliers and the product produced by them is equivalent.
We
have
also entered into manufacturing agreements for the supply of VQD-002 and Lenocta
to ensure that we will have sufficient material for clinical trials. In
addition, we are establishing the basis for commercial production capabilities.
As with any supply program, obtaining raw materials of the correct quality
cannot be guaranteed and we cannot ensure that we will be successful in this
endeavor.
At
the
time of commercial sale, to the extent possible and commercially practicable,
we
would seek to engage a back-up supplier for each of our product candidates.
Until such time, we expect that we will rely on a single contract manufacturer
to produce each of our product candidates under current Good Manufacturing
Practice, or cGMP, regulations. Our third-party manufacturers have a limited
number of facilities in which our product candidates can be produced and will
have limited experience in manufacturing our product candidates in quantities
sufficient for conducting clinical trials or for commercialization. Our
third-party manufacturers will have other clients and may have other priorities
that could affect their ability to perform the work satisfactorily and/or on
a
timely basis. Both of these occurrences would be beyond our control.
We
expect
to similarly rely on contract manufacturing relationships for any products
that
we may in-license or acquire in the future. However, there can be no assurance
that we will be able to successfully contract with such manufacturers on terms
acceptable to us, or at all.
Contract
manufacturers are subject to ongoing periodic and unannounced inspections by
the
FDA, the Drug Enforcement Agency and corresponding state agencies to ensure
strict compliance with cGMP and other state and federal regulations. Our
contractors in Europe face similar challenges from the numerous European Union
and member state regulatory agencies. We do not have control over third-party
manufacturers’ compliance with these regulations and standards, other than
through contractual obligations.
If
we
need to change manufacturers, the FDA and corresponding foreign regulatory
agencies must approve these new manufacturers in advance, which will involve
testing and additional inspections to ensure compliance with FDA regulations
and
standards and may require significant lead times and delay. Furthermore,
switching manufacturers may be difficult because the number of potential
manufacturers is limited. It may be difficult or impossible for us to find
a
replacement manufacturer quickly or on terms acceptable to us, or at
all.
GOVERNMENT
AND INDUSTRY 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:
·
preclinical
laboratory tests, animal studies, and formulation studies,
·
submission
to the FDA of an IND for human clinical testing, which must become effective
before human clinical trials may begin,
·
adequate
and well-controlled human clinical trials to establish the safety and efficacy
of the drug for each indication,
·
submission
to the FDA of an NDA,
·
satisfactory
completion of an FDA inspection of the manufacturing facility or facilities
at
which the drug is produced to assess compliance with current good manufacturing
practices, or cGMPs, and
·
FDA
review and approval of the NDA.
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 Lenocta received orphan drug
designation for the treatment of leishmaniasis in December 2006. Our product
candidate VQD-002 received orphan drug designation for the treatment of multiple
myeloma in February 2008.
Fast
Track Designation
The
FDA’s
fast track program is intended to facilitate the development and to expedite
the
review of drugs that are intended for the treatment of a serious or
life-threatening condition for which there is no effective treatment and which
demonstrate the potential to address unmet medical needs for the condition.
Under the fast track program, the sponsor of a new drug candidate may request
the FDA to designate the drug candidate for a specific indication as a fast
track drug concurrent with or after the filing of the IND for the drug
candidate. The FDA must determine if the drug candidate qualifies for fast
track
designation within 60 days of receipt of the sponsor’s request.
Our
product candidate Xyfid received fast track designation status in April 2005,
for the prevention of HFS in patients receiving capecitabine for the treatment
of advanced metastatic breast cancer as a fast track product. The FDA granted
Xyfid fast track designation for the treatment of HFS from the use of
capecitabine or 5-FU, as HFS is a serious condition for which there is currently
no approved therapy, and Xyfid shows potential for prevention and treatment
of
HFS as indicated by the pilot study’s clinical observations.
If
fast
track designation is obtained, the FDA may initiate review of sections of an
NDA
before the application is complete. This rolling review is available if the
applicant provides and the FDA approves a schedule for the submission of the
remaining information and the applicant pays applicable user fees. However,
the
time period specified in the Prescription Drug User Fees Act, which governs
the
time period goals the FDA has committed to reviewing an application, does not
begin until the complete application is submitted. Additionally, the fast track
designation may be withdrawn by the FDA if the FDA believes that the designation
is no longer supported by data emerging in the clinical trial process.
In
some
cases, a fast track designated drug candidate may also qualify for one or more
of the following programs:
Priority
Review. Under
FDA policies, a drug candidate is eligible for priority review, or review within
a six-month time frame from the time a complete NDA is accepted for filing,
if
the drug candidate provides a significant improvement compared to marketed
drugs
in the treatment, diagnosis or prevention of a disease. We cannot guarantee
any
of our drug candidates will receive a priority review designation, or if a
priority designation is received, that review or approval will be faster than
conventional FDA procedures, or that FDA will ultimately grant drug
approval.
Accelerated
Approval. Under
the FDA’s accelerated approval regulations, the FDA is authorized to approve
drug candidates that have been studied for their safety and effectiveness in
treating serious or life-threatening illnesses, and that provide meaningful
therapeutic benefit to patients over existing treatments based upon either
a
surrogate endpoint that is reasonably likely to predict clinical benefit or
on
the basis of an effect on a clinical endpoint other than patient survival.
In
clinical trials, surrogate endpoints are alternative measurements of the
symptoms of a disease or condition that are substituted for measurements of
observable clinical symptoms. A drug candidate approved on this basis is subject
to rigorous post-marketing compliance requirements, including the completion
of
Phase 4 or post-approval clinical trials to validate the surrogate endpoint
or confirm the effect on the clinical endpoint. Failure to conduct required
post-approval studies, or to validate a surrogate endpoint or confirm a clinical
benefit during post-marketing studies, will allow the FDA to withdraw the drug
from the market on an expedited basis. All promotional materials for drug
candidates approved under accelerated regulations are subject to prior review
by
the FDA. In rare instances FDA may grant accelerated approval of an NDA based
on
Phase 2 data and require confirmatory Phase 3 studies to be conducted after
approval and/or as a condition of maintaining approval. We can give no assurance
that any of our drugs will be reviewed under such procedures.
When
appropriate, we and our collaborators intend to seek fast track designation
or
accelerated approval for our drug candidates. We cannot predict whether any
of
our drug candidates will obtain a fast track or accelerated approval
designation, or the ultimate impact, if any, of the fast track or the
accelerated approval process on the timing or likelihood of FDA approval of
any
of our drug candidates.
Satisfaction
of FDA regulations and requirements or similar requirements of state, local
and
foreign regulatory agencies typically takes several years and the actual time
required may vary substantially based upon the type, complexity and novelty
of
the product or disease. Typically, if a drug candidate is intended to treat
a
chronic disease, as is the case with some of our drug candidates, safety and
efficacy data must be gathered over an extended period of time. Government
regulation may delay or prevent marketing of drug candidates for a considerable
period of time and impose costly procedures upon our activities. The FDA or
any
other regulatory agency may not grant approvals for new indications for our
drug
candidates on a timely basis, if at all. Even if a drug candidate receives
regulatory approval, the approval may be significantly limited to specific
disease states, patient populations and dosages. Further, even after regulatory
approval is obtained, later discovery of previously unknown problems with a
drug
may result in restrictions on the drug or even complete withdrawal of the drug
from the market. Delays in obtaining, or failures to obtain, regulatory
approvals for any of our drug candidates would harm our business. In addition,
we cannot predict what adverse governmental regulations may arise from future
United States or foreign governmental action.
Section
510(k)
We
may
pursue FDA clearance for Xyfid as a medical device pursuant to Section 510(k)
of
the Food Drug and Cosmetic Act, or FDCA. The FDA classifies medical devices
into
one of three classes. Devices deemed to pose lower risks are placed in either
Class I or II, which requires the manufacturer to submit to the FDA a premarket
notification requesting permission to commercially distribute the device. This
process is generally known as 510(k) clearance. Some low risk devices are exempt
from this requirement. Devices deemed by the FDA to pose the greatest risk,
such
as life-sustaining, life-supporting or implantable devices, or devices deemed
not substantially equivalent to a previously cleared 510(k) device, are placed
in Class III, requiring premarket approval.
When
a
510(k) clearance is required, the device sponsor must submit a premarket
notification demonstrating that its proposed device is substantially equivalent
to a previously cleared 510(k) device or a device that was in commercial
distribution. The evidence required to prove substantial equivalence varies
with
the risk posed by the device and its complexity. By regulation, the FDA is
required to complete its review of a 510(k) within 90 days of submission of
the
notification. As a practical matter, however, clearance often takes longer.
The
FDA may require further information, including clinical data, to make a
determination regarding substantial equivalence. If the FDA determines that
the
device, or its intended use, is not “substantially equivalent,” the FDA will
place the device, or the particular use of the device, into Class III, and
the
device sponsor must then fulfill much more rigorous pre-marketing requirements,
known as pre-market approval.
After
a
device receives 510(k) clearance for a specific intended use, any modification
that could significantly affect its safety or effectiveness, or that would
constitute a major change in its intended use, design or manufacture, will
require a new 510(k) clearance or could require a Pre-Market Approval
application, or PMA approval. The FDA requires each manufacturer to make this
determination initially, but the FDA can review any such decision and can
disagree with a manufacturer’s determination. If the FDA disagrees with a
manufacturer’s determination that a new clearance or approval is not required
for a particular modification, the FDA can require the manufacturer to cease
marketing and recall the modified device until 510(k) clearance or a PMA
approval is obtained. Also, in these circumstances, the manufacturer may be
subject to significant regulatory fines or penalties.
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 PATENTS
General
Patents
and other proprietary rights are very important to the development of our
business. We will be able to protect our proprietary technologies from
unauthorized use by third parties only to the extent that our proprietary rights
are covered by valid and enforceable patents, supported by regulatory data
exclusivity or are effectively maintained as trade secrets. It is our intention
to seek and maintain patent and trade secret protection for our drug candidates
and our proprietary technologies. As part of our business strategy, our policy
is to actively file patent applications in the United States and, when
appropriate, internationally to cover methods of use, new chemical compounds,
pharmaceutical compositions and dosing of the compounds and compositions and
improvements in each of these. We also rely on trade secret information,
technical know-how, innovation and agreements with third parties to continuously
expand and protect our competitive position. We have a number of patents and
patent applications related to our compounds and other technology, but we cannot
guarantee the scope of protection of the issued patents, or that such patents
will survive a validity or enforceability challenge, or that any of the pending
patent applications will issue as patents.
Generally,
patent applications in the United States are maintained in secrecy for a period
of 18 months or more. Since publication of discoveries in the scientific or
patent literature often lag behind actual discoveries, we are not certain that
we were the first to make the inventions covered by each of our pending patent
applications or that we were the first to file those patent applications. The
patent positions of biotechnology and pharmaceutical companies are highly
uncertain and involve complex legal and factual questions. Therefore, we cannot
predict the breadth of claims allowed in biotechnology and pharmaceutical
patents, or their enforceability. To date, there has been no consistent policy
regarding the breadth of claims allowed in biotechnology patents. Third parties
or competitors may challenge or circumvent our patents or patent applications,
if issued. If our competitors prepare and file patent applications in the United
States that claim technology also claimed by us, we may have to participate
in
interference proceedings declared by the United States Patent and Trademark
Office to determine priority of invention, which could result in substantial
cost, even if the eventual outcome is favorable to us. Because of the extensive
time required for development, testing and regulatory review of a potential
product, it is possible that before we commercialize any of our products, any
related patent may expire or remain in existence for only a short period
following commercialization, thus reducing any advantage of the patent.
If
a
patent is issued to a third party containing one or more preclusive or
conflicting claims, and those claims are ultimately determined to be valid
and
enforceable, we may be required to obtain a license under such patent or to
develop or obtain alternative technology. In the event of a litigation involving
a third party claim, an adverse outcome in the litigation could subject us
to
significant liabilities to such third party, require us to seek a license for
the disputed rights from such third party, and/or require us to cease use of
the
technology. Further, our breach of an existing license or failure to obtain
a
license to technology required to commercialize our products may seriously
harm
our business. We also may need to commence litigation to enforce any patents
issued to us or to determine the scope and validity of third-party proprietary
rights. Litigation would involve substantial costs.
Xyfid
We
have
an exclusive, world-wide license to U.S. and foreign patents and patent
applications claiming the Xyfid formulation and methods of using this
formulation for treatment of adverse dermatological conditions associated with
cancer treatment. Two U.S. patents with claims encompassing Xyfid have
issued.
U.S.
Patent No. 6,979,688 (“the ‘688 patent”) contains claims directed to methods of
reducing cutaneous side-effects of systemic therapy with 5-fluorouracil (5-FU)
or a precursor of 5-FU, the method comprising: applying uracil topically to
the
skin of a patient being treated concurrently and systemically with
5-fluorouracil (5-FIT) or a precursor of 5-FU in an amount effective to reduce,
at the site of topical uracil administration, the development of cutaneous
side-effects. The ‘688 patent also contains claims reciting methods of treating
breast or colorectal cancer with reduced cutaneous side-effects, the method
comprising: systemically administering 5-fluorouracil (5-FU) or a precursor
of
5-FU to a patient having breast or colorectal cancer; and concurrently applying
uracil topically to the patient's skin in an amount effective to reduce, at
the
site of topical uracil administration, the development of cutaneous
side-effects. The ‘688 patent will expire in 2023.
U.S.
Patent No. 6,995,165 (“the ‘165 patent”) contains claims encompassing kit for
the administration of at least one dose of an orally administrable
fluoropyrimidine prodrug or precursor with reduced cutaneous toxicity, the
kit
comprising: at least one dose of an orally administrable fluoropyrimidine
prodrug or precursor; and at least one dose of a topical composition comprising
uracil and a pharmaceutically acceptable carrier or excipient, wherein each
dose
of topical composition contains uracil in an amount that is both (i) sufficient,
at the site of topical application, to reduce the development of cutaneous
side-effects, and (ii) insufficient to produce a circulating uracil
concentration capable of causing clinically observable diminution in potency
or
efficacy of the kit’s fluoropyrimidine prodrug or precursor, or metabolite
thereof, at a neoplastic tissue desired to be treated. The ‘165 patent will
expire in 2023.
VQD-002
We
have
an exclusive, world-wide license to U.S. and foreign patents and patent
applications claiming the VQD-002 formulation and methods of using this
formulation for treatment various types of tumors and cancers. No U.S. patents
have issued at this time. However, the earliest expiration date of any U.S.
patent that issued is 2025.
Lenocta
We
have
an exclusive, world-wide license to U.S. and foreign patents and patent
applications claiming the Lenocta formulation and methods of using this
formulation for treatment various types of tumors and cancers. No U.S. or
foreign patents have issued or granted at this time. One U.S. patent application
and one European patent application have been allowed. Once issued, the patents
will expire in 2022.
Other
Intellectual Property Rights
We
depend
upon trademarks, trade secrets, know-how and continuing technological advances
to develop and maintain our competitive position. To maintain the
confidentiality of trade secrets and proprietary information, we require our
employees, scientific advisors, consultants and collaborators, upon commencement
of a relationship with us, to execute confidentiality agreements and, in the
case of parties other than our research and development collaborators, to agree
to assign their inventions to us. These agreements are designed to protect
our
proprietary information and to grant us ownership of technologies that are
developed in connection with their relationship with us. These agreements may
not, however, provide protection for our trade secrets in the event of
unauthorized disclosure of such information.
In
addition to patent protection, we may utilize orphan drug regulations or other
provisions of the Food, Drug and Cosmetic Act to provide market exclusivity
for
certain of our drug candidates. Orphan drug regulations provide incentives
to
pharmaceutical and biotechnology companies to develop and manufacture drugs
for
the treatment of rare diseases, currently defined as diseases that exist in
fewer than 200,000 individuals in the United States, or, diseases that affect
more than 200,000 individuals in the United States but that the sponsor does
not
realistically anticipate will generate a net profit. Under these provisions,
a
manufacturer of a designated orphan drug can seek tax benefits, and the holder
of the first FDA approval of a designated orphan product will be granted a
seven-year period of marketing exclusivity for such FDA-approved orphan product.
We believe that certain of the indications for our drug candidates will be
eligible for orphan drug designation; however, we cannot assure that our drugs
will obtain such orphan drug designation or that we will be the first to receive
FDA approval for such drugs so as to be eligible for market exclusivity
protection.
LICENSING
AGREEMENTS AND COLLABORATIONS
We
have
formed strategic alliances with a number of companies for the manufacture and
commercialization of our products. Our breach of an existing license or failure
to obtain a license to technology required to develop, test and commercialize
our products may seriously harm our business. Our current key strategic
alliances are discussed below.
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 Lenocta. We are obligated to make annual license maintenance
payments until the first commercial sale of Lenocta, 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.
In November 2007, the Company achieved a milestone obligation to CCF,
from the dosing of our first patient in our Phase IIa clinical trial. To date,
the Company has not fulfilled its payment obligation of $300,000 to CCF relating
to this milestone. Should Lenocta 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 Lenocta 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 Lenocta and
have the obligation to use all commercially reasonable efforts to bring Lenocta
to market. We have agreed to prosecute and maintain the patents associated
with
Lenocta 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.
License
with Asymmetric Therapeutics, LLC and Onc Res, Inc., assigned by Fiordland
Pharmaceuticals, Inc.
On March
29, 2007, the Company entered into an exclusive license agreement with
Asymmetric Therapeutics, LLC, or Asymmetric, and Onc Res, Inc., or Onc Res,
as
assigned by Fiordland Pharmaceuticals, Inc., or Fiordland. The agreement is
for
the rights to develop, manufacture, use, commercialize, lease, sell and/or
sublicense Xyfid. In consideration for the rights under the license agreement,
the Company paid to the licensor an aggregate $300,000 for license related
fees,
and $37,000 for patent prosecution costs. In addition, the Company paid to
a
third party finder a cash fee of $20,000 and a 5-year warrant to purchase
300,000 shares of the Company’s common stock at an exercise price of $0.50 per
share. The right to purchase the shares under the warrant vests in three equal
installments of 100,000 each, with the first installment being immediately
exercisable, and the remaining two installments vesting upon the achievement
of
certain clinical development and regulatory milestones relating to Xyfid. In
consideration of the license, the Company is required to make payments upon
the
achievement of various clinical development and regulatory milestones, which
total up to $6.2 million in the aggregate. The license agreement further
requires the Company to make payments of up to an additional $12.5 million
in
the aggregate upon the achievement of various commercialization and net sales
milestones. The Company will also be obligated to pay a royalty on net sales
of
the licensed product. We have agreed to prosecute and maintain the patents
associated with Xyfid or provide notice to Asymmetric and/or Onc Res 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
Asymmetric, 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.
EMPLOYEES
AND CONSULTANTS
As
of
March 27, 2008, we have three full-time employees and one part-time employee.
From time to time, we also employ independent contractors to assist with our
clinical and regulatory activities. None of our employees are represented by
a
collective bargaining unit. We consider our relations with our employees to
be
satisfactory.
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 and business development.
RISK
FACTORS
Risks
Related to Our Business
We
urgently require immediate additional financing in order to continue the
development of our products and otherwise develop our business operations.
Such
financing may not be available on acceptable terms, if at
all.
We
are in
urgent need of additional capital and anticipate that our current capital will
only be adequate to fund our operations into the second quarter of 2008.
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 clinical development and business
development areas. We will require substantial additional financing during
2008
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 development programs, 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. Alternatively, we may be required to
cease our operations altogether, in which case our stockholders may lose their
entire investment in our company.
Our
management anticipates incurring losses for the foreseeable
future.
For
the
year ended December 31, 2007, we had a net loss of $10,891,741, almost all
of
which related to our continuing operations. 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, and since our inception in October 2000 through December
31, 2007, we have incurred an aggregate net loss of $39,432,297. As of December
31, 2007, we had total assets of $1,358,353, of which $694,556 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
have not made a required milestone payment to The Cleveland Clinic Foundation
pursuant to the Lenocta license agreement.
During
the last quarter of 2007, we achieved a milestone that required us to make
a
milestone payment to The Cleveland Clinic Foundation pursuant to the Lenocta
license agreement. We have been unable to pay the milestone payment. We have
informed The Cleveland Clinic Foundation of the milestone and our current
inability to pay the milestone payment. Though we intend to make the milestone
payment with the proceeds from our future financings, provided that such
proceeds are sufficient, The Cleveland Clinic Foundation may, at any time before
the milestone payment is made, notify us that we are in breach of the license
agreement. Upon receipt of such notice, we would have to make the milestone
payment during the applicable cure period or the license agreement could be
terminated.
We
have no meaningful operating history on which to evaluate our business or
prospects.
We
commenced operations in October 2000 through our former Chiral Quest business,
which we sold in July 2007. In August 2004, we determined to become engaged
in
the drug development business and acquired rights to our first two drug
candidates in October 2005 through our acquisition of Greenwich Therapeutics.
In
March 2007, we acquired the rights to our third drug candidate from Fiordland
Pharmaceuticals, Inc. 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
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.
Dr.
Lindsay A. Rosenwald is the chairman and sole owner of Paramount BioCapital,
Inc. and such affiliates. Dr. Rosenwald beneficially owns approximately 7%
of
our outstanding common stock, and several trusts for the benefit of Dr.
Rosenwald and his family beneficially own 19% 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
us.
From
the rights 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
require significant additional capital in the immediate near future to operate
our business. 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. 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. In addition, if we do not receive substantial additional capital
in
the immediate near future, we may also be required to cease operations
altogether, in which case you would likely lose all of your
investment.
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.
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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.
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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.
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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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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 at 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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developments
concerning proprietary rights, including
patents;
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regulatory
developments in the United States and foreign
countries;
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economic
or other crises and other external
factors;
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period-to-period
fluctuations in our revenues and other results of
operations;
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changes
in financial estimates by securities analysts;
and
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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. DESCRIPTION OF PROPERTY
We
lease
office space in 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 $416,000 for rent and utilities expires in January
2012.
In
connection with the sale of the Company’s Chiral Quest Subsidiary, on July 16,
2007, the Company entered into a sublease agreement with Chiral Quest
Acquisition Corp. (“CQAC”), which purchased Chiral Quest, to lease office and
laboratory space in Monmouth Junction, New Jersey used in Chiral Quest’s
business. The sublease agreement provides for a term that will expire on May
30,
2008. CQAC agreed to make all payments of base rent and additional rent that
the
Company is obligated to pay under its lease agreement for such space. If CQAC
were to default on payment during the sublease agreement’s term, the Company
would be obligated to provide payment to its landlord on behalf of CQAC through
the remainder of the original lease term, and the Company will have the right
to
cancel and terminate the sublease with CQAC upon 5 days notice to subtenant.
To
date, CQAC has fully complied with the sublease agreement with the
Company.
We
believe our existing facilities, as described above, are adequate to meet our
needs at least through the year ending December 31, 2008.
ITEM
3. 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
4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None.
PART
II
ITEM
5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS AND SMALL BUSINESS
ISSUER PURCHASES OF EQUITY SECURITIES.
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
|
|
High
|
|
Low
|
|
March
31, 2006
|
|
$
|
0.85
|
|
$
|
0.81
|
|
June
30, 2006
|
|
$
|
0.80
|
|
$
|
0.77
|
|
September
30, 2006
|
|
$
|
0.65
|
|
$
|
0.60
|
|
December
31, 2006
|
|
$
|
0.53
|
|
$
|
0.43
|
|
March
31, 2007
|
|
$
|
0.75
|
|
$
|
0.45
|
|
June
30, 2007
|
|
$
|
0.64
|
|
$
|
0.36
|
|
September
30, 2007
|
|
$
|
0.55
|
|
$
|
0.25
|
|
December
31, 2007
|
|
$
|
0.37
|
|
$
|
0.09
|
|
Record
Holders
As
of
March 21, 2008, we had approximately 1,790 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 fiscal-year
2007 and we do not currently have any publicly-announced repurchase plans in
effect.
ITEM
6. MANAGEMENT’S
DISCUSSION AND ANALYSIS OR PLAN OF OPERATIONS.
Overview
Through
our continuing drug development business, we acquire develop and intend to
commercialize novel drug therapies targeting the molecular basis of cancer
and
side effects of treatment.
We
commenced operations in October 2000 as Chiral Quest, LLC, and in February
2003,
we completed a reverse acquisition of Surg II, Inc. a publicly-held shell
corporation and were renamed to Chrial Quest, Inc. In August 2004, we changed
our name to VioQuest Pharmaceuticals, Inc. and have focused on acquiring novel
drug therapies targeting the molecular basis of cancer and side effects of
treatment. In October 2005 we acquired Greenwich Therapeutics, Inc., a
privately-held New York based company, through which we obtained the rights
to
develop, manufacture, use, commercialize, lease, sell and/or sublicense Lenocta
(sodium stibogluconate) and VQD-002 (triciribine phosphate monohydrate) through
license agreements with The Cleveland Clinic Foundation and the University
of
South Florida Research Foundation, respectively. We have initiated three Phase
I
and one Phase IIa clinical trials since acquiring the license rights to Lenocta
and VQD-002. In March 2007, we obtained an exclusive, worldwide license to
certain patents relating to Xyfid from Asymmetric Therapeutics, LLC and Onc
Res,
Inc., as assigned to the Company by Fiordland Pharmaceuticals, Inc.
From
our
inception to July 2007, through our Chiral Quest subsidiary, we provided
innovative chiral products, technology and custom synthesis services to
pharmaceutical and final chemical companies in all stages of a product’s life
cycle. On September 29, 2006, our Board of Directors determined to seek
strategic alternatives for our Chiral Quest business, which included a possible
sale or other disposition of the operating assets of that business. On July
16,
2007, we completed the sale of Chiral Quest to CQAC for total cash consideration
of approximately $1,700,000. As a result of this transaction, we reported a
gain
of $438,444, which is included in its loss from discontinued operations for
the
year ended December 31, 2007. Accordingly, the chiral products and services
operations and the assets of Chiral Quest are presented in these consolidated
financial statements as discontinued operations. Chiral Quest had accounted
for
all of our sales since our inception. Our continuing operations, which have
not
generated any revenues, will focus on our remaining drug development operations,
and accordingly, we have only one segment.
Since
inception, we have incurred an accumulated deficit of $39,432,297 through
December 31, 2007. For the year ended December 31, 2007 we had losses from
continuing operations of $10,628,048, and used cash in continuing operating
activities totaling $6,289,503. As of December 31, 2007, we had a working
capital deficit of $4,534,289 and cash and cash equivalents of $694,556. As
a
result, as of the date of this Report, we have insufficient funds to cover
our
current obligations or future operating expenses. To conserve funds, we will
continue to complete our current ongoing Phase I and Phase II studies for
VQD-002 and Lenocta, respectively, however we will not initiate any new clinical
studies unless and until we receive additional funding. We expect our operating
losses to increase over the next several years, due to the expansion of our
drug
development business, and related costs associated with the clinical development
programs of Lenocta, VQD-002 and Xyfid, in addition to costs related to license
fees, manufacturing of our products, regulatory costs, and the hiring of
additional people in the clinical development and business development areas.
These matters raise substantial doubt about our ability to continue as a going
concern.
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 our product
candidate Xyfid until 2009 for the treatment of HFS, Lenocta and VQD-002 until
2012 for oncology indications, 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 clinical,
regulatory and 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.
Results
of Operations - Years Ended December 31, 2007 vs. 2006
Continuing
Operations:
We
had no
revenues from our continuing operations through December 31, 2007.
In-process
research and development, or (“IPR&D”) costs for the year ended December 31,
2007 was $963,225 as compared to $0 for the year ended December 31, 2006.
IPR&D costs are attributed to shares and warrants issued to shareholders of
Greenwich Therapeutics, Inc. that were placed in escrow to be released based
upon the achievement of certain milestones. See Note 4 for a complete discussion
of the agreement. On October 12, 2007, 2,997,540 shares and 700,001 warrants
were released from escrow following 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 Lenocta. The costs are comprised of
$805,054 related to the calculated value of 2,997,540 shares of the Company’s
common stock issued to Greenwich Therapeutics’ shareholders valued at $0.27 per
share ($0.27 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
October 12, 2007 event) and $158,171 related to the calculated value of 700,001
warrants issued to Greenwich Therapeutics’ shareholders using the Black-Scholes
option pricing model.
Research
and development, or (“R&D”), expenses for the year ended December 31, 2007
were $4,988,145 as compared to $1,819,736 for the year ended December 31, 2006.
R&D is attributed to clinical development costs, milestone license fees,
maintenance fees provided to the licensors, outside manufacturing costs, outside
clinical research organization costs, in addition to regulatory and patent
filing costs associated with our drug candidates Lenocta, VQD-002 and
Xyfid.
The
following table sets forth the research and development expenses per compound,
for the periods presented.
|
|
|
Years
ended December 31,
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Cumulative
amounts during development
|
|
Lenocta
|
|
$
|
2,056,598
|
|
$
|
823,396
|
|
$
|
2,879,994
|
|
VQD-002
|
|
|
2,136,680
|
|
|
996,340
|
|
|
3,133,020
|
|
Xyfid
|
|
|
794,867
|
|
|
-
|
|
|
794,867
|
|
Total
|
|
$
|
4,988,145
|
|
$
|
1,819,736
|
|
$
|
6,807,881
|
|
The
following table sets forth the research and development expenses for the
year-ended December 31, 2007 by expense category, for our three oncology
compounds.
|
|
|
Drug
Candidate
|
|
|
|
|
|
|
|
Lenocta
|
|
|
VQD-002
|
|
|
Xyfid
|
|
|
Year-ended
December
31,
2007
|
|
Clinical
Research Costs
|
|
$
|
766,332
|
|
$
|
894,582
|
|
$
|
43,181
|
|
$
|
1,704,095
|
|
Labor
Costs
|
|
|
285,540
|
|
|
598,375
|
|
|
138,221
|
|
|
1,022,136
|
|
Regulatory
/ Legal Fees
|
|
|
431,947
|
|
|
345,522
|
|
|
47,817
|
|
|
825,285
|
|
Licensing
/ Milestone Fees
|
|
|
381,806
|
|
|
25,000
|
|
|
369,588
|
|
|
776,394
|
|
Other
|
|
|
190,973
|
|
|
273,202
|
|
|
196,060
|
|
|
660,236
|
|
Total
|
|
$
|
2,056,598
|
|
$
|
2,136,680
|
|
$
|
794,867
|
|
$
|
4,988,145
|
|
The
following table sets forth the research and development expenses for the
year-ended December 31, 2006 by expense category, for our three oncology
compounds.
|
|
|
Drug
Candidate
|
|
|
|
|
|
|
|
Lenocta
|
|
|
VQD-002
|
|
|
Xyfid
|
|
|
Year-ended
December
31,
2006
|
|
Clinical
Research Costs
|
|
$
|
220,780
|
|
$
|
233,126
|
|
$
|
-
|
|
$
|
453,906
|
|
Labor
Costs
|
|
|
192,554
|
|
|
192,554
|
|
|
-
|
|
|
385,108
|
|
Regulatory
/ Legal Fees
|
|
|
255,594
|
|
|
189,194
|
|
|
-
|
|
|
444,788
|
|
Licensing
Fees
|
|
|
64,164
|
|
|
141,666
|
|
|
-
|
|
|
205,830
|
|
Other
|
|
|
90,304
|
|
|
239,800
|
|
|
-
|
|
|
330,104
|
|
Total
|
|
$
|
823,396
|
|
$
|
996,340
|
|
$
|
-
|
|
$
|
1,819,736
|
|
The
increase in R&D for the year ended December 31, 2007, is a result of
acquiring Xyfid in March 2007 and advancing our clinical studies in 2007.
Additionally, we incurred year-over-year increases in clinical research
organization costs of $1,250,000, employee related costs of $637,000, licensing
and milestone fees of $570,000 and outside regulatory and legal fees of
$380,000. The increase in licensing and milestone fees was due in part to
licensee fees for the acquisition of Xyfid for $300,000 in March 2007 and
licensee fees for the first dosing of a patient in the first Phase IIa clinical
trial for Lenocta in December 2007 for $300,000, offset by licensee fees for
receiving acceptance of our Investigational New Drug Application filing for
VQD-002 for $100,000 in April 2006. We expect R&D spending related to our
existing product candidates to continue to significantly increase over the
next
several years as we expand our clinical trials.
General
and administrative, or (“G&A”), expenses for the year ended December 31,
2007 were $3,791,089 as compared to $3,461,529 during the year ended December
31, 2006. This increase in G&A expenses was due in part to severance
benefits due to the former Chief Executive Officer of approximately $200,000,
employment agency fees related to the appointment of the President and Chief
Executive Officer of approximately $120,000, additional spending to ensure
compliance with Section 404 of the Sarbanes-Oxley Act of 2002 of approximately
$64,000 and additional spending on professional fees and rent for the Basking
Ridge, New Jersey headquarters, offset by a decrease in SFAS No. 123R expense
of
approximately $476,000 related to the expiration of unvested options of the
former President and Chief Executive Officer.
Interest
expense, net of interest income for the year ended December 31, 2007 was
$1,126,273 as compared to interest income, net of interest expense of $105,695
for the year ended December 31, 2006. Interest expense for the year ended
December 31, 2007 was primarily composed of interest on the Bridge Notes issued
in June and July 2007 of approximately $1,195,615, which was offset by interest
income of approximately $74,000. The decrease in interest income for the year
ended December 31, 2007 is attributed to having a lower cash balance throughout
2007. 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 debt owed to Paramount BioSciences, LLC., which was assumed as
part
of the October 2005 acquisition of Greenwich Therapeutics. The debt was repaid
in July 2007.
Our
loss
from continuing operations for the year ended December 31, 2007 was $10,628,048
as compared to $5,175,570 for the year ended December 31, 2006. The increased
loss from continuing operations for the year ended December 31, 2007 as compared
to the year ended December 31, 2006 was attributable to higher in-process
research and development costs related to shares and warrants released from
escrow and issued to Greenwich Therapeutics, R&D costs related to our drug
development efforts, including outside clinical research organization costs,
employee related costs, regulatory and legal fees, maintenance and licensing
fees provided to the institutions we licensed Lenocta and VQD-002 from and
acquisition fees of Xyfid, paid to the licensor in 2007. Additionally, G&A
expense increased as a result of accruing for severance benefits due to the
former President and Chief Executive Officer, employment agency fees related
to
the appointment of the Company’s recently appointed President and Chief
Executive Officer in November 2007, additional spending to ensure compliance
with Section 404 of the Sarbanes-Oxley Act of 2002, additional spending on
professional fees, increased rent for the Basking Ridge, New Jersey
headquarters, offset by a decrease in SFAS No. 123R expense related to the
expiration of unvested options of the former President and Chief Executive
Officer.
Discontinued
Operations:
Our
loss
from discontinued operations for the year ended December 31, 2007 was $263,693
as compared to $3,095,594 for the year ended December 31, 2006. The decreased
loss from discontinued operations for the year ended December 31, 2007 as
compared to December 31, 2006 was primarily attributable to the sale of Chiral
Quest to CQAC for total cash consideration of approximately $1,700,000 in July
2007. As a result of this transaction, the Company reported a gain on sale
of
$438,444. Additionally, the decreased loss from 2007 compared to 2006, is
attributed to a partial year of operations during 2007, versus an entire year
of
operations for 2006.
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 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.
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 Lenocta and VQD-002, outside manufacturing costs,
outside clinical research organization costs, in addition to regulatory and
patent filing costs associated with two of our oncology compounds currently
in
clinical trials, Lenocta and VQD-002. The increase in R&D for the year ended
December 31, 2006, is a result of having no R&D costs from Lenocta and
VQD-002 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 Lenocta 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.
G&A
expenses for the year ended December 31, 2006 were $3,461,529 as compared to
$2,421,088 during the year ended December 31, 2005. This increase in G&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 G&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.
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 Lenocta and VQD-002
from, in addition to other clinical development costs for the Lenocta and
VQD-002 clinical programs.
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.
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 - Lenocta and VQD-002. The rights
to
these two oncology drug candidates, Lenocta 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 Lenocta and VQD-002. Since
acquiring the license rights to Lenocta and VQD-002, we have initiated three
Phase I and one Phase IIa clinical trials.
In
March
2007, we acquired license rights to develop and commercialize Xyfid. Our rights
to Xyfid are governed by a license agreement with Asymmetric Therapeutics,
LLC
and Onc Res, Inc., as assigned to us by Fiordland Pharmaceuticals, Inc. The
license gives us the right to develop, manufacture, use, commercialize, lease,
sell and/or sublicense Xyfid.
As
a
result of acquiring the license rights to Lenocta, VQD-002 and Xyfid, we
immediately undertook funding their development, 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 Lenocta, VQD-002 and Xyfid, all of which are in the early stages
of clinical development, is a very lengthy and expensive process. Until such
development is complete and the FDA (or the comparable regulatory authorities
of
other countries) approves Lenocta, VQD-002 and Xyfid for sale, we will not
be
able to sell these products.
Since
inception, we have incurred an accumulated deficit of $39,432,297 through
December 31, 2007. For the year ended December 31, 2007, we had losses from
continuing operations of $10,628,048 and used $6,289,503 in cash from continuing
operating activities for year ended December 31, 2007. As of December 31, 2007,
we had a working capital deficit of $4,534,289 and cash and cash equivalents
of
$694,556. As a result, as of the date of this Report, we have insufficient
funds
to cover our current obligations or future operating expenses.
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 Lenocta, VQD-002 and Xyfid. These matters raise substantial doubt about
our
ability to continue as a going concern.
On
March
14, 2008, we issued 765 shares of Series A Convertible Preferred Stock at a
price of $1,000 per share resulting in aggregate gross proceeds of $765,000.
Each
share of Series A Convertible Preferred Stock sold is convertible into shares
of
the Company's common stock at $0.10 per share, or approximately 7.65
million shares of common stock in the aggregate. We
also
issued to investors five-year warrants to purchase an aggregate of
approximately 3.8 million shares of our common stock at an exercise price
of $0.17 per share. Based upon the Black-Scholes option pricing model, the
investor warrants are estimated to be valued at approximately $420,000. In
connection with the offering, we engaged Paramount as our placement agent.
Dr.
Lindsay A. Rosenwald is the Chairman, CEO and sole stockholder of Paramount
and
a substantial stockholder of the Company. Dr. Rosenwald participated in this
financing, through a family investment partnership, of which he is the managing
member. In consideration for the placement agent's services, we paid an
aggregate of approximately $54,000 in commissions to Paramount in connection
with the offering. We also paid to Paramount $35,000 as a non-accountable
expense allowance. In addition, we issued to Paramount five-year warrants to
purchase an aggregate of approximately 765,000 shares of common stock, which
are
exercisable at a price of $0.14 per share. Based upon the Black-Scholes option
pricing model, the warrants issued to Paramount are estimated to be
valued at approximately $84,000.
The
Series A Convertible Preferred Stock shall be entitled to an annual dividend
equal to 6% of the applicable issuance price per annum, payable semi-annually
in
cash or shares of common stock, at the option of the Company. If the Company
chooses to pay the dividend in shares of common stock, the price per share
of
common stock to be issued shall be equal to 90% of the average closing price
of
the common stock for the 20 trading days prior to the date that such dividend
becomes payable. As
a
condition to the initial closing of the private placement, the majority of
the
holders of the June 29, 2007 and July 3, 2007 convertible promissory notes
agreed to convert such notes, together with accrued interest, into approximately
3,910 shares of the Company’s newly-designated Series B Convertible Preferred
Stock.
On
July
16, 2007, we completed the sale of our discontinued operations Chiral Quest,
Inc., and received $1.7 million in gross proceeds, of which we recognized
$197,000 in accrued compensation costs related to a severance agreement and
retention bonuses payable to certain key employees. Additionally, the purchaser
assumed liabilities in the aggregate amount of approximately $807,000 pursuant
to the purchase agreement.
On
June
29, 2007 and July 3, 2007 we issued a series of convertible promissory notes
resulting in aggregate gross proceeds of $3.7 million. We also issued to
investors five-year warrants to purchase an aggregate of approximately 2.43
million shares of our common stock at an exercise price of $0.40 per share.
Based upon the Black-Scholes option pricing model, the investor warrants are
estimated to be valued at approximately $909,000. In connection with the
offering, we engaged Paramount as one of our placements agents. Dr. Lindsay
A.
Rosenwald is the Chairman, CEO and sole stockholder of Paramount and a
substantial stockholder of the Company. Stephen C. Rocamboli, a director of
the
Company, was employed by Paramount at the time of our engagement. In
consideration for the placement agents’ services, we paid an aggregate of
approximately $256,000 in commissions to the placement agents in connection
with
the offering, of which $119,700 was paid to Paramount. We also paid to placement
agents approximately $24,000 as a non-accountable expense allowance. In
addition, we issued placement agents five-year warrants to purchase an aggregate
of approximately 1.2 million shares of common stock, of which 450,000 shares
of
common stock were issued to Paramount, which are exercisable at a price of
$0.42
per share. Based upon the Black-Scholes option pricing model, the placement
agents’ warrants are estimated to be valued at approximately
$430,000.
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, was
employed by Paramount until August 2007. 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 model, the
investor warrants are estimated to be valued at approximately $1,363,000. Based
upon the Black-Scholes option pricing model, the placement agents’ warrants are
estimated to be valued at approximately $195,000.
Management
anticipates that our capital resources will be adequate to fund our operations
into the second quarter of 2008. Additional financing or
potential sublicensing of our rights to our product(s)
will be
required during the second quarter of 2008, if not sooner in order to continue
to fund operations. 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,
2007 was $6,289,503. Our net cash used in operating activities primarily
resulted from a net loss of $10,891,741 offset by a loss from discontinued
operations of $263,693, non-cash items consisting of in-process research and
development costs of $963,225 related to the release of shares and warrants
issued to Greenwich Therapeutics that were released from escrow, the impact
of
expensing employee and director stock options in accordance with SFAS No. 123R
of $462,704, the impact of expensing scientific advisory board member
consultants’ options and non-employee finder’s fee options related to the
license acquisition of Xyfid in accordance with Emerging Issues Task Force
(“EITF”) 96-18 for $62,193, amortization of the discount on our bridge note of
$1,195,615, depreciation of $8,877 and loss on disposal of assets of $5,253.
Increases in cash in continuing operating activities include a decrease in
other
assets of $102,005 and prepaid clinical research organization costs of $83,813
attributed to our three oncology compounds’ development. Additional increases in
cash from continuing operations included an increase in accounts payable of
$842,042 and accrued expenses of $612,818, which was attributed to clinical
development costs, professional fees and compensation.
Our
net
cash used in continuing investing activities for the year ended December 31,
2007 totaled $5,127, which resulted from capital expenditures attributed to
the
purchases of computer and office equipment for the Basking Ridge, New Jersey
facility.
Our
net
cash provided by continuing financing activities for the year ended December
31,
2007 was $3,150,081, which was primarily attributed to a series of notes issued
to investors for $3,414,704, net of placement agents’ commissions and other
related costs associated with issuing the such notes, offset by the repayment
of
debt for $264,623 owed to Paramount BioSciences LLC, which was attributable
to
the acquisition of Greenwich Therapeutics, Inc. in 2005.
At
our
current and desired pace of clinical development of our three products currently
in Phase I and Phase IIa clinical trials, over the next 12 months we expect
to
spend approximately $5.3 million on clinical trials and research and development
(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 three drug candidates
from, salaries and consulting fees, pre-clinical and laboratory studies),
approximately $170,000 on facilities, rent and other facilities costs, and
approximately $1.4 million on general corporate and working capital. Our current
resources are inadequate to continue to fund operations; therefore, we will
need
to raise capital by the second quarter of 2008 if not sooner. Furthermore,
based
upon the amount of capital we are required to raise by the end of the second
quarter of 2008 to continue operations, we may need to raise additional capital
before then to continue to fund our operations at our desired pace throughout
2008, by selling shares of our equity securities or issuing debt, or by
potentially sublicensing our rights to our products.
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.
We
may
not be able to obtain the additional capital that we need to fund our operations
on reasonable terms, or even at all. If adequate financing is not available,
we
may be required to terminate or significantly curtail our operations, enter
into
arrangements with collaborative partners or others that may require us to
relinquish rights to certain of our technologies, potential markets that we
would not otherwise relinquish, or cease our operations altogether.
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 Lenocta. We
are
obligated to make an annual license maintenance payment until the first
commercial sale of Lenocta, 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. In November 2007, the Company
achieved a milestone obligation to CCF, from the dosing of our first
patient in our Phase IIa clinical trial. To date, the Company has not fulfilled
its payment obligation of $300,000 to CCF relating to this milestone. Should
Lenocta 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 Lenocta
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 Lenocta and have the obligation to use all
commercially reasonable efforts to bring Lenocta to market. We have agreed
to
prosecute and maintain the patents associated with Lenocta 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.
License
with with Asymmetric Therapeutics, LLC and Onc Res, Inc., assigned by Fiordland
Pharmaceuticals, Inc.
We have
an exclusive license agreement with Asymmetric and Onc Res, as assigned by
Fiordland for the rights to develop, manufacture, use, commercialize, lease,
sell and/or sublicense Xyfid. In consideration for the rights under the license
agreement, the Company paid to the licensor an aggregate $300,000 for license
related fees, and incurred approximately $37,000 for patent prosecution costs.
In addition, the Company paid to a third party finder a cash fee of $20,000
and
a 5-year warrant to purchase 300,000 shares of the Company’s common stock at an
exercise price of $0.50 per share. The right to purchase the shares under the
warrant vests in three equal installments of 100,000 each, with the first
installment being immediately exercisable, and the remaining two installments
vesting upon the achievement of certain clinical development and regulatory
milestones relating to Xyfid. The Company has recognized approximately $50,000
of expense in the first quarter of 2007 based upon the immediate vesting of
the
first 100,000 options. In consideration of the license, the Company is required
to make payments upon the achievement of various clinical development and
regulatory milestones, which total up to $6.2 million in the aggregate. The
license agreement further requires the Company to make payments of up to an
additional $12.5 million in the aggregate upon the achievement of various
commercialization and net sales milestones. The Company will also be obligated
to pay a royalty on net sales of the licensed product. We have agreed to
prosecute and maintain the patents associated with Xyfid or provide notice
to
Asymmetric and/or Onc Res 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 Asymmetric, 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.
The
following table summarizes our long-term contractual obligations at December
31,
2007:
|
|
Payments
due by period
|
|
|
|
Total
|
|
Less
than
1
year
|
|
1-3
years
|
|
3-5
years
|
|
More
than
5
years
|
|
Contractual
Obligations
|
|
|
|
|
|
|
|
|
|
|
|
Convertible
Promissory Notes Obligations (1) (3)
|
|
$
|
3,700,000
|
|
$
|
3,700,000
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
Continuing
Operating Lease Obligations (2)
|
|
|
416,500
|
|
|
101,500
|
|
|
315,000
|
|
|
-
|
|
|
-
|
|
Total
|
|
$
|
4,116,500
|
|
$
|
3,801,500
|
|
$
|
315,000
|
|
$
|
-
|
|
$
|
-
|
|
____________
|
(1)
|
Convertible
Promissory Notes Obligations are notes payable to accredited investors
that may convert into shares of the Company’s common stock. The total
principal obligation is for $3,700,000. In addition, the Company
expects
to become obligated to pay interest of $301,920. Interest is accrued
at
the annual
rate of 8%, compounded semi-annually, during the one-year term. The
Company may elect to extend the term to an additional year, which
election
would trigger an increase in the annual interest rate to 12%, compounded
semi-annually, during the extended term and the Company would become
obligated to pay additional interest in the amount of
$326,557.
|
(2) |
Operating
Lease Obligations are payment obligations under an “operating lease” as
classified by FASB Statement of Financial Accounting Standards No.
13.
According to SFAS No. 13, any lease that does not meet the criteria
for a
“capital lease” is considered an “operating
lease.”
|
(3) |
As
of March 14, 2008, the Company is no longer obligated to repay the
convertible promissory notes as a result of the majority of the note
holders converting their notes to Convertible Preferred Stock as
a
condition to the March 14, 2008
financing.
|
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
consolidated 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 consolidated 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 model 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 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 2007, the FASB issued Statement No. 160, Noncontrolling
Interests in Consolidated Financial Statements -- an amendment of ARB No. 51
(“SFAS
No.
160”). SFAS No. 160 requires that ownership interests in subsidiaries held by
parties other than the parent, and the amount of consolidated net income, be
clearly identified, labeled, and presented in the consolidated financial
statements within equity, but separate from the parent's equity. SFAS No. 160
applies to all entities that prepare consolidated financial statements, but
will
affect only those entities that have an outstanding noncontrolling interest
in
one or more subsidiaries or that deconsolidate a subsidiary. SFAS No. 160 is
effective for fiscal years, and interim periods within those fiscal years,
beginning on or after December 15, 2008. Earlier adoption is prohibited. SFAS
No. 160 will be effective for the Company beginning January 1, 2009. Management
does not expect that the application of this standard will have any significant
effect on the Company's consolidated financial statements.
In
December 2007, the FASB issued Statement No. 141R, Business
Combinations (“SFAS
No.
141R”). SFAS No. 141R requires an acquirer to recognize the assets acquired, the
liabilities assumed, and any noncontrolling interest in the acquiree at the
acquisition date. Additionally, it requires an acquirer to measure goodwill
as
of the acquisition date as a residual that includes the recognition of
contingent consideration at its fair value and financial effects of the business
combination. In most types of business combinations will result in measuring
goodwill as the excess of the consideration transferred plus the fair value
of
any noncontrolling interest in the acquiree at the acquisition date over the
fair values of the identifiable net assets acquired. SFAS No. 141R applies
prospectively to business combinations for which the acquisition date is on
or
after the beginning of the first annual reporting period beginning on or after
December 15, 2008. Earlier adoption is prohibited. Management does not expect
that the application of this standard will have any significant effect on the
Company's consolidated financial statements.
In
February 2007, the FASB issued Statement No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities - Including
an
amendment of FASB Statement No. 115 (“SFAS
No.
159”). This standard amends FASB Statement No. 115, Accounting
for Certain Investment in Debt and Equity Securities,
with
respect to accounting for a transfer to the trading category for all entities
with available-for-sale and trading securities electing the fair value option.
This standard allows companies to elect fair value accounting for many financial
instruments and other items that currently are not required to be accounted
as
such, allows different applications for electing the option for a single item
or
groups of items, and requires disclosures to facilitate comparisons of similar
assets and liabilities that are accounted for differently in relation to the
fair value option. SFAS No. 159 is effective for fiscal years beginning after
November 15, 2007. Management does not expect that the application of this
standard will have any significant effect on the Company's consolidated
financial statements.
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(T). CONTROLS AND PROCEDURES
Under
the
supervision and with the participation of our management, including the Chief
Executive Officer and Chief Financial Officer, we have evaluated the
effectiveness of our disclosure controls and procedures as required by Exchange
Act Rule 13a-15(b) as of the end of the period covered by this report. Based
on
that evaluation, the Chief Executive Officer and Chief Financial Officer have
concluded that these disclosure controls and procedures are
effective.
REPORT
OF
MANAGEMENT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting for the Company. Internal control over
financial reporting is a process to provide reasonable assurance regarding
the
reliability of our financial reporting for external purposes in accordance
with
accounting principles generally accepted in the United States of America.
Internal control over financial reporting includes maintaining records that
in
reasonable detail accurately and fairly reflect our transactions; providing
reasonable assurance that transactions are recorded as necessary for preparation
of our consolidated financial statements; providing reasonable assurance that
receipts and expenditures of company assets are made in accordance with
management authorization; and providing reasonable assurance that unauthorized
acquisition, use or disposition of company assets that could have a material
effect on our consolidated financial statements would be prevented or detected
on a timely basis. Because of its inherent limitations, internal control over
financial reporting is not intended to provide absolute assurance that a
misstatement of our consolidated financial statements would be prevented or
detected.
Management
conducted an evaluation of the effectiveness of our internal control over
financial reporting based on the framework in Internal Control—Integrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission. Based on this evaluation, management concluded that the Company’s
internal control over financial reporting was effective as of December 31,
2007.
There were no changes in our internal control over financial reporting during
the quarter ended December 31, 2007 that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
ITEM
8B. OTHER INFORMATION
On
March
20, 2008, the Company’s Chief Scientific and Medical Officer, Dr. Edward
Bradley, entered into an agreement to reduce Dr. Bradley’s base salary of
$330,000 to $165,000, as well as reducing the number of hours he is required
to
provide to the Company in view of the Company’s current financial position. All
other benefits and compensation offered to Dr. Bradley pursuant to his
employment offer letter with the Company dated January 31, 2007, which are
comprised of any eligible bonus, stock options awards and vesting, medical
benefits and severance, will remain in effect, with the exception of the
foregoing reduction in hours and salary.
On
March
14, 2008, the Company issued 765 shares of Series A Convertible
Preferred Stock. The Series A Convertible Preferred Stock was issued at
80% of the offering price for the 20 trading days preceding March 14, 2008.
The
Company also issued to each investor in the offering warrants to purchase a
number of shares of the Company’s common stock equal to 50% of the aggregate
number of convertible shares into common stock, with each warrant having an
exercise price of 130% or $0.17 per share. The Company also issued to the
placement agent in the offering warrants to purchase a number of shares of
the
Company’s common stock equal to 10% of the aggregate number of convertible
shares into common stock, with each warrant having an exercise price of 110%
or
$0.14 per share. The Series A Convertible Preferred Stock shall be entitled
to
an annual dividend equal to 6% of the applicable issuance price per annum,
payable semi-annually in cash or shares of common stock, at the option of the
Company. If the Company chooses to pay the dividend in shares of common stock,
the price per share of common stock to be issued shall be equal to 90% of the
average closing price of the common stock for the 20 trading days prior to
the
date that such dividend becomes payable.
PART
III
ITEM
9. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS AND CORPORATE
GOVERNANCE; COMPLIANCE WITH SECTION 16(a) OF THE EXCHANGE
ACT.
Information
in response to this Item is incorporated herein by reference to our 2008 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 2008 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 2008 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,
AND DIRECTOR INDEPENDENCE.
Information
in response to this Item is incorporated herein by reference to our 2008 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
13. EXHIBITS.
Exhibit
No.
|
|
Description
|
|
2.1
|
|
|
Agreement
and Plan of Merger dated July 1, 2005 by and among the Registrant,
VQ
Acquisition Corp. and Greenwich Therapeutics, Inc.(incorporated by
reference to Exhibit 2.1 to the Registrant’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 Registrant, VQ Acquisition Corp. and Greenwich Therapeutics,
Inc. (incorporated by reference to Exhibit 2.2 to the Registrant’s Form
10-QSB filed November 14, 2005).
|
|
2.3
|
|
|
Agreement
and Plan of Merger dated October 14, 2005 by and between the Registrant
and VioQuest Delaware, Inc. (incorporated by reference to Exhibit
10.1 to
the Registrant’s Form 8-K filed October 20, 2005).
|
|
2.4
|
|
|
Stock
Purchase and Sale Agreement dated April 10, 2007 between the Registrant
and Chiral Quest Acquisition Corp. (incorporated by reference to
Appendix
A to the Registrant’s Definitive Proxy Statement on Schedule 14A filed
April 25, 2007).
|
|
2.5
|
|
|
Amendment
No. 1 to Stock Purchase and Sale Agreement dated June 8, 2007 between
the
Registrant and Chiral Quest Acquisition Corp. (incorporated by reference
to Exhibit 10.1 to the Registrant’s 8-K filed June 12,
2007).
|
|
3.1
|
|
|
Certificate
of Incorporation, as amended to date.**
|
|
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).
|
|
3.3
|
|
|
Certificate
of Designation of Series A Convertible Preferred Stock and Series
B
Convertible Preferred Stock (incorporated by reference to Exhibit
3.1
filed with the Registrant’s Form 8-K filed on March 20,
2008).
|
|
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).
|
|
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).
|
|
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).
|
|
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).
|
|
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).
|
|
4.10
|
|
|
Form
of senior convertible promissory note issued by Registrant on June
29,
2007 and July 3, 2007 (incorporated by reference to Exhibit 4.1 of
the
Registrant’s Form 8-K filed July 6, 2007).
|
|
4.11
|
|
|
Form
of warrant issued to investors by Registrant on June 29, 2007 and
July 3,
2007 (incorporated by reference to Exhibit 4.1 of the Registrant’s Form
8-K filed July 6, 2007).
|
|
10.1
|
|
|
2003
Stock Option Plan, as amended. **
|
|
10.2
|
|
|
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).++
|
|
10.3
|
|
|
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).++
|
|
10.4
|
|
|
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).
|
|
10.5
|
|
|
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).
|
|
10.6
|
|
|
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).
|
|
10.7
|
|
|
Severance
Benefits Agreement dated August 8, 2006 by and between the Registrant
and
Brian Lenz (incorporated by reference to Exhibit 10.3 to the Registrant’s
Quarterly Report on Form 10-QSB for the period ended June 30, 2006).
|
|
10.8
|
|
|
Form
of subscription agreement between the Registrant 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).
|
|
10.9
|
|
|
First
Amendment to Lease dated September 15, 2006 between the Registrant
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).
|
|
10.10
|
|
|
Letter
Agreement between the Registrant and Edward C. Bradley, dated January
31,
2007 (incorporated by reference to Exhibit 10.1 to the Registrant’s
Current Report on Form 8-K filed on February 6, 2007).
|
|
10.11
|
|
|
Amended
and Restated License Agreement dated December 29, 2006, among Onc
Res,
Inc., Asymmetric Therapeutics, LLC, Fiordland Pharmaceuticals, Inc.,
and
Stason Pharmaceuticals, Inc., as assigned to the Registrant on March
29,
2007 (incorporated by reference to Exhibit 10.2 on the Registrant’s 10-QSB
for the period ended March 31, 2007).++
|
|
10.12
|
|
|
Form
of Note and Warrant Purchase Agreement between the Registrant and
various
investors accepted as of June 29, 2007 and July 3, 2007 (incorporated
by
reference to Exhibit 4.1 of the Registrant’s Form 8-K filed July 6,
2007).
|
|
10.13
|
|
|
Sublease
dated July 16, 2007 between the Registrant and Chiral Quest Acquisition
Corp. (incorporated by reference to Exhibit 10.2 to the Registrant’s
10-QSB for the period ended September 30, 2007).
|
|
10.14
|
|
|
Employment
Agreement between the Registrant and Michael D. Becker, dated November
11,
2007.**
|
|
10.15
|
|
|
Form
of Stock Option Agreement for use under the 2003 Stock Option Plan
(incorporated by reference to Exhibit 10.15 filed with the Registrant’s
Annual Report on Form 10-KSB for the year ended December 31,
2006).
|
|
10.16
|
|
|
Separation
and Release Agreement between the Registrant and Daniel Greenleaf
dated
November 14, 2007.**
|
|
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.
**
Filed
herewith.
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
Information
in response to this Item is incorporated herein by reference to our 2008 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 27, 2008.
|
|
|
|
VioQuest
Pharmaceuticals, Inc. |
|
|
|
|
By: |
/s/ Michael
D. Becker |
|
Michael
D. Becker |
|
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/
Michael D. Becker
|
|
President
& Chief Executive Officer and Director
|
|
March
27, 2008
|
Michael
Becker
|
|
(Principal
Executive Officer)
|
|
|
|
|
|
|
|
/s/
Brian Lenz
|
|
Chief
Financial Officer and Treasurer
|
|
March
28, 2008
|
Brian
Lenz
|
|
(Principal
Financial and Accounting Officer)
|
|
|
|
|
|
|
|
/s/
Johnson Y. N. Lau
|
|
Director
|
|
March
27, 2008
|
Johnson
Y. N. Lau
|
|
|
|
|
|
|
|
|
|
/s/
Stephen C. Rocamboli
|
|
Chairman
of the Board
|
|
March
24, 2008
|
Stephen
C. Rocamboli
|
|
|
|
|
|
|
|
|
|
/s/
Michael Weiser
|
|
Director
|
|
March
24, 2008
|
Michael
Weiser
|
|
|
|
|
Index
to Consolidated Financial Statements
|
|
Page
|
|
|
|
|
|
Report
of J.H. Cohn LLP
|
|
|
F-2
|
|
|
|
|
|
|
Consolidated
Balance Sheets as of December 31, 2007 and 2006
|
|
|
F-3
|
|
|
|
|
|
|
Consolidated
Statements of Operations for the Years Ended December 31, 2007 and
2006
|
|
|
F-4
|
|
|
|
|
|
|
Consolidated
Statements of Changes in Stockholders’ Equity (Deficiency) for the Years
Ended December 31, 2007 and 2006
|
|
|
F-5
|
|
|
|
|
|
|
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2007 and
2006
|
|
|
F-6
|
|
|
|
|
|
|
Notes
to Consolidated Financial Statements
|
|
|
F-7
to F-23
|
|
Report
of Independent Registered Public Accounting Firm
The
Board
of Directors and stockholders
VioQuest
Pharmaceuticals, Inc.
We
have
audited the accompanying consolidated balance sheets of VioQuest
Pharmaceuticals, Inc. and Subsidiaries as of December 31, 2007 and 2006, and
the
related consolidated statements of operations, changes in stockholders' equity
(deficiency) 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
consolidated financial statements are free of material misstatement. An audit
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the consolidated 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, 2007 and 2006, 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 and
a
stockholders’ deficiency at December 31, 2007 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.
/s/J.H.
Cohn LLP
Roseland,
New Jersey
March
31,
2008
CONSOLIDATED
BALANCE SHEETS
AS
OF DECEMBER 31,
|
|
2007
|
|
2006
|
|
ASSETS
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
694,556
|
|
$
|
2,931,265
|
|
Prepaid
clinical research costs
|
|
|
189,359
|
|
|
273,172
|
|
Deferred
financing costs
|
|
|
357,581
|
|
|
-
|
|
Other
current assets
|
|
|
66,836
|
|
|
168,841
|
|
Current
assets associated with discontinued operations
|
|
|
-
|
|
|
2,396,435
|
|
Total
Current Assets
|
|
|
1,308,332
|
|
|
5,769,713
|
|
|
|
|
|
|
|
|
|
PROPERTY
AND EQUIPMENT, NET
|
|
|
34,789
|
|
|
43,378
|
|
SECURITY
DEPOSITS
|
|
|
15,232
|
|
|
15,232
|
|
TOTAL
ASSETS
|
|
$
|
1,358,353
|
|
$
|
5,828,323
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,873,500
|
|
$
|
1,031,458
|
|
Accrued
compensation and related taxes
|
|
|
373,460
|
|
|
245,475
|
|
Other
accrued expenses
|
|
|
665,273
|
|
|
180,440
|
|
Note
payable - Paramount BioSciences, LLC
|
|
|
-
|
|
|
264,623
|
|
Convertible
notes, net of unamortized debt discount of $917,612
|
|
|
2,930,388
|
|
|
-
|
|
Current
liabilities associated with discontinued operations
|
|
|
-
|
|
|
1,265,568
|
|
TOTAL
LIABILITIES
|
|
|
5,842,621
|
|
|
2,987,564
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
Preferred
stock; $0.001 par value: 10,000,000 shares authorized, 0 shares issued
and
outstanding
|
|
|
-
|
|
|
-
|
|
Common
stock; $0.001 par value: 200,000,000 shares authorized, 54,621,119
shares
issued and outstanding
|
|
|
54,621
|
|
|
54,621
|
|
Additional
paid-in capital
|
|
|
34,893,408
|
|
|
31,326,694
|
|
Accumulated
deficit
|
|
|
(39,432,297
|
)
|
|
(28,540,556
|
)
|
Total
Stockholders' Equity (Deficiency)
|
|
|
(4,484,268
|
)
|
|
2,840,759
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY)
|
|
$
|
1,358,353
|
|
$
|
5,828,323
|
|
See
accompanying notes to consolidated financial statements.
CONSOLIDATED
STATEMENTS OF OPERATIONS
FOR
THE YEARS ENDED DECEMBER 31,
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
In-process
research and development
|
|
$
|
963,225
|
|
$
|
-
|
|
Research
and development
|
|
|
4,988,145
|
|
|
1,819,736
|
|
General
and administrative
|
|
|
3,791,089
|
|
|
3,461,529
|
|
Total
Operating Expenses
|
|
|
9,742,459
|
|
|
5,281,265
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS
|
|
|
(9,742,459
|
)
|
|
(5,281,265
|
)
|
|
|
|
|
|
|
|
|
INTEREST
(EXPENSE) / INCOME, NET
|
|
|
(1,126,273
|
)
|
|
105,695
|
|
|
|
|
|
|
|
|
|
LOSS
BEFORE INCOME TAXES
|
|
|
(10,868,732
|
)
|
|
(5,175,570
|
)
|
|
|
|
|
|
|
|
|
INCOME
TAX BENEFIT
|
|
|
240,684
|
|
|
-
|
|
|
|
|
|
|
|
|
|
LOSS
FROM CONTINUING OPERATIONS
|
|
|
(10,628,048
|
)
|
|
(5,175,570
|
)
|
|
|
|
|
|
|
|
|
DISCONTINUED
OPERATIONS
|
|
|
|
|
|
|
|
Loss
from discontinued operations, net of income tax benefit of $0 and
$201,079
for the years ended December 31, 2007 and 2006,
respectively
|
|
|
(702,137
|
)
|
|
(3,095,594
|
)
|
Gain
on sale of business
|
|
|
438,444
|
|
|
-
|
|
LOSS
FROM DISCONTINUED OPERATIONS, NET OF TAX BENEFIT
|
|
|
(263,693
|
)
|
|
(3,095,594
|
)
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$
|
(10,891,741
|
)
|
$
|
(8,271,164
|
)
|
|
|
|
|
|
|
|
|
NET
LOSS PER SHARE:
|
|
|
|
|
|
|
|
CONTINUING
OPERATIONS
|
|
$
|
(0.23
|
)
|
$
|
(0.13
|
)
|
DISCONTINUED
OPERATIONS
|
|
|
(0.00
|
)
|
|
(0.08
|
)
|
|
|
|
|
|
|
|
|
NET
LOSS PER SHARE - BASIC AND DILUTED
|
|
$
|
(0.23
|
)
|
$
|
(0.21
|
)
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING - BASIC AND DILUTED
|
|
|
46,721,932
|
|
|
39,786,686
|
|
See
accompanying notes to consolidated financial statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIENCY)
FOR
THE YEARS ENDED DECEMBER 31, 2007 AND 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
|
|
|
Stockholders'
|
|
|
|
|
Common
Stock
|
|
|
Paid-In
|
|
|
Accumulated
|
|
|
Equity
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
(Deficiency)
|
|
Balance,
January 1, 2006
|
|
|
46,729,519
|
|
$
|
46,729
|
|
$
|
26,561,672
|
|
$
|
(20,269,392
|
)
|
$
|
6,339,009
|
|
Net
loss for the year ended December 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
(8,271,164
|
)
|
|
(8,271,164
|
)
|
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 and finder
|
|
|
|
|
|
|
|
|
83,523
|
|
|
|
|
|
83,523
|
|
Balance,
December 31, 2006
|
|
|
54,621,119
|
|
$
|
54,621
|
|
$
|
31,326,694
|
|
$
|
(28,540,556
|
)
|
$
|
2,840,759
|
|
Net
loss for the year ended December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
(10,891,741
|
)
|
|
(10,891,741
|
)
|
Fair
value of beneficial conversion feature and warrants issued in conjunction
with convertible notes
|
|
|
|
|
|
|
|
|
2,037,512
|
|
|
|
|
|
2,037,512
|
|
October
12, 2007 release of shares and warrants held in escrow
|
|
|
|
|
|
|
|
|
963,225
|
|
|
|
|
|
963,225
|
|
Stock-based
compensation to employees
|
|
|
|
|
|
|
|
|
500,700
|
|
|
|
|
|
500,700
|
|
Stock-based
compensation to consultants and finder
|
|
|
|
|
|
|
|
|
65,277
|
|
|
|
|
|
65,277
|
|
Balance,
December 31, 2007
|
|
|
54,621,119
|
|
$
|
54,621
|
|
$
|
34,893,408
|
|
$
|
(39,432,297
|
)
|
$
|
(4,484,268
|
)
|
See
accompanying notes to consolidated financial statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
FOR
THE YEARS ENDED DECEMBER 31,
|
|
2007
|
|
2006
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
Net
loss
|
|
$
|
(10,891,741
|
)
|
$
|
(8,271,164
|
)
|
Loss
from discontinued operations
|
|
|
263,693
|
|
|
3,095,594
|
|
Loss
from continuing operations
|
|
|
(10,628,048
|
)
|
|
(5,175,570
|
)
|
Adjustments
to reconcile loss from continuing operations to net cash used in
continuing operating activities:
|
|
|
|
|
|
|
|
In-process
research and development
|
|
|
963,225
|
|
|
-
|
|
Depreciation
|
|
|
8,877
|
|
|
6,304
|
|
Loss
on disposal of assets
|
|
|
5,253
|
|
|
-
|
|
Stock-based
compensation to employees
|
|
|
462,704
|
|
|
830,715
|
|
Stock-based
compensation to consultants and finder
|
|
|
62,193
|
|
|
33,830
|
|
Amortization
of debt discount and deferred financing fees
|
|
|
1,195,615
|
|
|
-
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
Prepaid
clinical research costs
|
|
|
83,813
|
|
|
(273,172
|
)
|
Other
assets
|
|
|
102,005
|
|
|
(164,420
|
)
|
Accounts
payable
|
|
|
842,042
|
|
|
756,381
|
|
Accrued
expenses
|
|
|
612,818
|
|
|
30,915
|
|
Net
Cash Used in Continuing Operating Activities
|
|
|
(6,289,503
|
)
|
|
(3,955,017
|
)
|
Discontinued
Operating Activities:
|
|
|
|
|
|
|
|
Gain
on sale of business
|
|
|
(438,444
|
)
|
|
-
|
|
Net
cash used in discontinued operating activities
|
|
|
(354,281
|
)
|
|
(2,502,814
|
)
|
Net
Cash Used in Operating Activities
|
|
|
(7,082,228
|
)
|
|
(6,457,831
|
)
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
Payments
for purchased equipment
|
|
|
(5,127
|
)
|
|
(28,406
|
)
|
Net
Cash Used in Continuing Investing Activities
|
|
|
(5,127
|
)
|
|
(28,406
|
)
|
Discontinued
Investing Activities:
|
|
|
|
|
|
|
|
Proceeds
from sale of business
|
|
|
1,727,263
|
|
|
-
|
|
Other
net cash used in discontinued investing activities
|
|
|
(26,698
|
)
|
|
(253,143
|
)
|
Net
Cash Provided By / (Used in) Investing Activities
|
|
|
1,695,438
|
|
|
(281,549
|
)
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
Proceeds
from private placement of common stock, net of
$296,554 in financing costs
|
|
|
-
|
|
|
3,649,246
|
|
Proceeds
from issuance of convertible notes with warrants, net of cash costs
of
$285,296
|
|
|
3,414,704
|
|
|
-
|
|
Repayment
of note payable
|
|
|
(264,623
|
)
|
|
-
|
|
Net
Cash Provided By Continuing Financing Activities
|
|
|
3,150,081
|
|
|
3,649,246
|
|
|
|
|
|
|
|
|
|
NET
DECREASE IN CASH AND CASH EQUIVALENTS
|
|
|
(2,236,709
|
)
|
|
(3,090,134
|
)
|
CASH
AND CASH EQUIVALENTS - BEGINNING OF YEAR
|
|
|
2,931,265
|
|
|
6,021,399
|
|
CASH
AND CASH EQUIVALENTS - END OF YEAR
|
|
$
|
694,553
|
|
$
|
2,931,265
|
|
|
|
|
|
|
|
|
|
Supplemental
Schedule of Non-Cash Investing and Financing
Activities:
|
|
|
|
|
|
|
|
Value
of warrants issued to the placement agent in connection with issuances
of
convertible notes
|
|
$
|
429,866
|
|
$
|
-
|
|
Value
of beneficial conversion feature related to convertible
notes
|
|
$
|
877,823
|
|
$
|
-
|
|
See
accompanying notes to consolidated financial statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
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 current and former subsidiaries. All significant
intercompany accounts and transactions have been eliminated in consolidation.
The functional currency of Chiral Quest, Ltd., Jiashan, China, formerly a
wholly-owned, discontinued subsidiary of the Company, was the United States
Dollar. As such, all transaction gains and losses were recorded in discontinued
operations.
On
September 29, 2006, the Company’s Board of Directors determined to seek
strategic alternatives with respect to the Company’s Chiral Quest, Inc.
subsidiary (“Chiral Quest”), which included a possible sale or other disposition
of the operating assets of that business. Accordingly, the chiral products
and
services operations and the assets of Chiral Quest are presented in these
consolidated financial statements as discontinued operations. On July 16, 2007,
the Company completed the sale of Chiral Quest to Chiral Quest Acquisition
Corp.
(“CQAC”) for total cash consideration of approximately $1,700,000. As a result
of this transaction, the Company reported a gain of $438,444, which is included
in its loss from discontinued operations for the year ended December 31, 2007.
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 remaining drug development operations of VioQuest Pharmaceuticals,
Inc. and accordingly, the Company has only one segment. As a result of these
reclassifications, the Company no longer provides segment reporting. See Note
3
for a complete discussion on discontinued operations.
The
consolidated balance sheets as of December 31, 2007 and December 31, 2006 and
the consolidated statements of operations and cash flows for the years then
ended include reclassifications 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 infectious diseases for which there are unmet medical
needs. Since October 2005, the Company has held license rights to develop and
commercialize its two oncology drug candidates, Lenocta (sodium stibogluconate),
formerly VQD-001, an inhibitor of specific protein tyrosine phosphatases, and
VQD-002 (triciribine-phosphate monohydrate), an inhibitor of activated Akt.
The
rights to these two oncology drug candidates, Lenocta and VQD-002, are governed
by license agreements with The Cleveland Clinic Foundation and the University
of
South Florida Research Foundation, respectively. In March 2007, the Company
acquired license rights to develop and commercialize Xyfid (1% uracil topical),
an adjunctive therapy for the treatment and prevention of Hand-Foot Syndrome
(“HFS”), a common and serious side effect of chemotherapy treatments. The
Company’s rights to Xyfid are governed by a license agreement with Asymmetric
Therapeutics, LLC and Onc Res, Inc., as assigned to the Company by Fiordland
Pharmaceuticals, Inc.
(C)
Liquidity
Since
inception, the Company has incurred an accumulated deficit of $39,432,297
through December 31, 2007. For the years ended December 31, 2007 and 2006,
the
Company had losses from continuing operations of $ 10,628,048 and $5,175,570,
respectively, and used $6,289,503 and $3,955,017 of cash in continuing operating
activities for the years ended December 31, 2007 and 2006, respectively. For
the
years ended December 31, 2007 and 2006, the Company had a net loss of
$10,891,741 (including $10,628,048 from continuing operations) and a net loss
of
$8,271,164 (including $5,175,570 from continuing operations), respectively,
and
used $7,082,228 and $6,457,831 of cash in all operating activities for the
years
ended December 31, 2007 and 2006, respectively. As of December 31, 2007, the
Company had a working capital deficit of $4,534,289 and cash and cash
equivalents of $694,556. The Company has incurred negative cash flow from
operating activities since its inception. The Company has spent, and expects
to
continue to spend, substantial amounts in connection with executing its business
strategy, including planned development efforts relating to the Company’s drug
candidates, clinical trials and other research and development
efforts. As
a
result, as of the date of this Report, we have insufficient funds to cover
our
current obligations or future operating expenses. To conserve funds, we will
continue to complete our current ongoing Phase I and Phase II studies for
VQD-002 and Lenocta, respectively, however we will not initiate any new clinical
studies unless and until we receive additional funding. These
matters raise substantial doubt about the ability of the Company to continue
as
a going concern.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
On
July
16, 2007 the Company completed the sale of Chiral Quest, which resulted in
gross
proceeds to the Company of approximately $1,700,000, as well as the assumption
by the purchaser of approximately $807,000 of liabilities. See Note 3. On June
29, 2007 and July 3, 2007, the Company also received gross proceeds of
$3,700,000 from the sale of 8% convertible promissory notes. See Note 6. The
Company’s cash and cash equivalents at December 31, 2007 reflect the remaining
cash proceeds to the Company from those transactions.
Management
anticipates that the Company’s capital resources will be adequate to fund its
operations into the second quarter of 2008. Additional financing or
potential sublicensing of our rights to our product(s)
will be
required during the second quarter of 2008, if not sooner in order to continue
to fund operations. The most likely sources of additional financing include
the
private sale of the Company’s equity or debt securities, including bridge loans
to the Company from third party lenders. 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 is urgently needed by the Company 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 or cease 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 current and former subsidiaries. All significant
intercompany accounts and transactions have been eliminated in consolidation.
The Company translated the financial statements of its formerly wholly-owned
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 convertible notes 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).
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
(E)
Income Taxes
Under
Statement of Financial Accounting Standards No. 109, Accounting for Income
Taxes (“SFAS No. 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.
Under
SFAS No. 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
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.
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 consolidated 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. SFAS No. 123R also requires that
forfeitures be estimated and recorded over the vesting period of the instrument.
The Company uses the Black-Scholes option pricing model to value these
awards.
The
Company accounts for stock options granted to non-employees on a fair value
basis using the Black-Scholes option pricing model 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.
(G)
Use of Estimates
The
preparation of consolidated 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 consolidated 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.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
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 to 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 5,566,856 common shares
held in escrow based
upon clinical milestones of Lenocta 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 35,849,716 (including the 5,566,856
common
shares held in escrow, 20,149,470 warrants, and 10,133,390 stock options) at
December 31, 2007 and 30,294,586 at December 31, 2006.
(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 determined that it would
seek strategic alternatives for Chiral Quest and accordingly, the operations
and
assets of Chrial Quest have been presented in these consolidated financial
statements as discontinued operations. On July 16, 2007, the Company completed
the sale of Chiral Quest to CQAC for total cash consideration of approximately
$1,700,000
gross proceeds, of which we recognized $197,000 in accrued compensation costs
related to a severance agreement and retention bonuses payable to certain key
employees. Additionally, the Purchaser assumed liabilities in the aggregate
amount of approximately $807,000 as part of the purchase price consideration.
As
a result of this transaction, the Company reported a gain of $438,444 in the
third quarter of 2007, which is included in its loss from discontinued
operations for the year ended December 31, 2007.
At
July
16, 2007 and December 31, 2006, the total assets of discontinued operations
were
$1,898,702 and $2,396,435 respectively, which consisted of accounts receivable,
inventories, prepaid expenses, fixed assets, net of accumulated depreciation,
patents, net of accumulated amortization, security deposits and prepaid rent.
Total liabilities as of July 16, 2007 and December 31, 2006 associated with
discontinued operations totaled $806,644 and $1,265,568 respectively, which
consisted of accounts payable, accrued expenses and deferred revenues. The
gain
on sale of Chiral Quest was $438,444. Retention bonuses of $106,761 and accrued
severance of $90,000 paid to certain Chiral Quest employees have been offset
against the gain on sale. Revenues from discontinued operations for the years
ended December 31, 2007 and 2006 were $1,484,584 and 2,738,652, respectively.
Loss from discontinued operations (which excludes the gain on sale of Chiral
Quest) for the years ended December 31, 2007 and 2006, 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 $702,137 and $3,095,594, respectively.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
On
July
16, 2007, the Company entered into a sublease agreement with CQAC that will
expire on May 30, 2008 to lease its office and laboratory space, which was
utilized by Chiral Quest before it was sold to CQAC. CQAC, the subtenant, agreed
to make all payments of base rent and additional rent totaling approximately
$28,000 per month for a total commitment of $140,000 remaining on the sublease
agreement payable directly to the landlord. If CQAC were to default on payment
during the sublease agreement’s term, the Company would be obligated to provide
payment on behalf of CQAC through the remainder of the original lease term,
and
the Company will have the right to cancel and terminate the sublease with CQAC
upon five days notice to subtenant. As of December 31, 2007, CQAC has fully
complied with the sublease agreement with the Company.
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 to be released
based upon the achievement of certain milestones as follows:
|
(i)
|
35%
of the escrowed securities were earned on October 12, 2007, from
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 Lenocta or SSG;
|
|
(ii)
|
15%
of the escrowed securities shall be released immediately upon conclusion
of a Phase II clinical trial for Lenocta 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
Lenocta
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).
|
As
a
result of 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 Lenocta on October 12, 2007, 2,997,540 shares and
700,001 warrants were released from escrow and issued to Greenwich Therapeutics.
The value of the shares and warrants of $963,225 was determined to be in-process
research and development and is comprised of $805,054 related to the calculated
value of 2,997,540 shares of the Company’s common stock issued to Greenwich
Therapeutics’ shareholders valued at $.27 per share ($.27 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 October 12, 2007 event) and $158,171
related to the calculated value of 700,001 warrants issued to Greenwich
Therapeutics’ shareholders using the Black-Scholes option pricing
model.
As
of
December 31, 2007, 5,566,856 shares and 1,299,999 warrants remain in escrow,
to
be released upon the achievement of the remaining milestones described above.
In
the event the remaining escrowed 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.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
The
cost
of the major classes of property and equipment are as follows:
|
|
|
December
31, 2007
|
|
|
December
31, 2006
|
|
Office
equipment
|
|
$
|
20,280
|
|
$
|
27,346
|
|
Computer
equipment
|
|
|
29,999
|
|
|
24,123
|
|
Property
and equipment
|
|
|
50,279
|
|
|
51,469
|
|
Less
accumulated depreciation
|
|
|
15,490
|
|
|
8,091
|
|
Property
and Equipment, Net
|
|
$
|
34,789
|
|
$
|
43,378
|
|
Depreciation
expense for property and equipment for continuing operations for the years
ended
December 31, 2007 and 2006 was $8,877 and $6,304, respectively.
NOTE
6 CONVERTIBLE
NOTES
On
June
29, 2007 and July 3, 2007, the Company issued and sold a series of 8%
convertible promissory notes (the “Bridge Notes”) in the aggregate principal
amount of $3,700,000 with a term of one year from the date of final closing.
Investors may, at any time during the term, elect to convert all unpaid
principal plus any accrued but unpaid interest thereon on the Bridge Notes
into
shares of the Company’s common stock. In the event that the investors do not
elect to convert the Bridge Notes, all unpaid principal plus any accrued
interest automatically convert into the Company’s common stock upon the
completion of an equity financing or series of related equity financings by
the
Company resulting in aggregate gross cash proceeds to the Company of at least
$7,000,000. If the Bridge Notes and accrued interest are not converted into
shares of the Company’s common stock, all unpaid principal plus any accrued
interest shall be due and payable on the first anniversary of the final
closing.
The
face
value of the Bridge Notes issued on June 29, 2007 and July 3, 2007, was
$2,967,500 and $732,500, respectively. The Company incurred commissions and
related costs in association with the Bridge Notes of $234,721 and $50,575
(as
explained below) for the June 29, 2007 and July 3, 2007 closings, respectively.
The Company also issued to investors five-year warrants (“Bridge Warrants”) to
purchase an aggregate of approximately 2,430,000 (1,950,000 and 480,000 for
the
June 29, 2007 and July 3, 2007 closings, respectively) shares of the Company’s
common stock at an exercise price of $0.40 per share, which had a fair value
of
$736,935 and $172,301 as of June 29, 2007 and July 3, 2007, respectively. The
Company allocated proceeds from the sale to the Bridge Warrants of $590,334
and
$139,489 as of June 29, 2007 and July 3, 2007, respectively, based on their
relative fair values to the fair value of the Bridge Notes, which was recorded
as a discount to the Bridge Notes. Gross proceeds allocated to the Bridge Notes
were $2,377,166 for the June 29, 2007 issuances, and $593,011 for the July
3,
2007 issuances. The discount associated with the value of the warrants will
be
amortized to interest expense over the term of the Bridge Notes.
As
a
result of the allocation of proceeds to the Bridge Warrants, the Bridge Notes
contained a Beneficial Conversion Feature (“BCF”) of $590,334 for the June 29,
2007 closing, and $139,489 for the July 3, 2007 closing, which were attributable
to an effective conversion price for the Company’s common stock that was less
than the market values on the dates of issuance. Additional BCFs are recorded
as
convertible interest is accrued. These amounts are recorded as additional debt
discount and additional paid-in capital, which reduces the initial carrying
value of the Bridge Notes. The discount associated with the BCF is being
amortized to interest expense over the term of the Bridge Notes.
The
following table summarizes information about the Bridge Notes and debt discount
as of December 31, 2007:
Face
value of convertible notes
|
|
$
|
3,700,000
|
|
Accrued
but unpaid interest
|
|
|
148,000
|
|
|
|
|
|
|
Gross
value of convertible notes
|
|
|
3,848,000
|
|
|
|
|
|
|
Debt
discount attributable to Bridge Warrants
|
|
|
729,823
|
|
BCF
attributable to Bridge Warrants
|
|
|
877,823
|
|
BCF
attributable to convertible interest
|
|
|
148,000
|
|
Less:
Amortization of debt discount
|
|
|
(838,034
|
)
|
|
|
|
|
|
Unamortized
debt discount
|
|
|
917,612
|
|
|
|
|
|
|
Convertible
notes, net of unamortized debt discount
|
|
$
|
2,930,388
|
|
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
In
connection with the Bridge Notes, the Company issued five-year warrants to
placement agents to purchase an aggregate of 1,202,500 shares of common stock,
which are exercisable at a price of $0.42 per share. Based on the Black-Scholes
option pricing model, the warrants had a fair value of $353,663 for the June
29,
2007 closing and $76,203 for the July 3, 2007 closing. Additionally, the Company
incurred commissions of $205,450, a non-accountable expense allowance of $24,271
to the placement agents and escrow fees of $5,000 for the June 29, 2007 closing
and commissions of $50,575 for the July 3, 2007 closing. The fair value of
the
warrants, commissions and fees totaling $596,618 for the June 29, 2007 closing
and $118,543 for the July 3, 2007 closing have been recognized as deferred
financing costs, which will be amortized to interest expense over the term
of
the Bridge Notes.
The
following table summarizes information about the deferred financing costs as
of
December 31, 2007:
Deferred
financing costs
|
|
$
|
715,161
|
|
Less:
Accumulated amortization
|
|
|
(357,580
|
)
|
|
|
|
|
|
Deferred
financing costs, net
|
|
$
|
357,581
|
|
The
following assumptions were used for the Black-Scholes calculations for the
warrants related to the Bridge Notes:
Term
|
|
|
5
years
|
|
Volatility
|
|
|
240
|
%
|
Dividend
yield
|
|
|
0.0
|
%
|
Risk-free
interest rate
|
|
|
4.9-5.0
|
%
|
NOTE
7 INCOME
TAXES
The
Company recognized a tax benefit of $240,684 for the year ended December 31,
2007 as a result of the sale of its New Jersey net operating losses (“NOL’s”)
from its continuing operations.
The
significant components of the Company’s net deferred tax assets are summarized
as follows:
|
|
Year
Ended December 31,
|
|
|
|
2007
|
|
2006
|
|
NOL
carryforwards - Federal
|
|
$
|
9,605,910
|
|
$
|
6,168,321
|
|
NOL
carryforwards - State
|
|
|
1,061,842
|
|
|
674,556
|
|
Tax
credits - Federal
|
|
|
377,179
|
|
|
-
|
|
Tax
credits - State
|
|
|
483,949
|
|
|
483,949
|
|
Inventory
reserve
|
|
|
-
|
|
|
170,800
|
|
Employee
and consultant stock compensation
|
|
|
748,209
|
|
|
416,058
|
|
Accrued
compensation
|
|
|
144,660
|
|
|
-
|
|
Other,
net
|
|
|
(1,756
|
)
|
|
114,748
|
|
Valuation
allowance
|
|
|
(12,419,993
|
)
|
|
(8,028,432
|
)
|
Net
deferred tax assets
|
|
$
|
-
|
|
$
|
-
|
|
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
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, 2007, we had available for federal and state income tax reporting
purposes NOL carryforwards in the approximate amount of $28,253,000 and
$17,697,000 respectively, expiring through 2027, which are available to reduce
future earnings that would otherwise be subject to federal and state income
taxes. The Tax Reform Act of 1986 (the Act) contains provisions, which limit
the
ability to utilize net operating loss carryforwards in the case of certain
events including significant changes in ownership interest. The Company has
experienced various ownership changes, as defined by the Act, as a result of
past financings and may experience others in connection with future financings.
Accordingly, a substantial portion of the Company's aforementioned net operating
loss carryforwards will be subject to annual limitations in reducing any future
year's taxable income. Additionally, because U.S. tax laws limit the time during
which these carryforwards may be applied against future taxes, the Company
will
likely not be able to take full advantage of these attributes for federal and
state income tax purposes. Furthermore, as of December 31, 2007, we have Federal
research and development credits and Section 1231 loss credits in the
approximate amount of $376,000 and $1,000, respectively, which are available
to
reduce the amount of future federal income taxes. These credits expire from
2008
through 2026, and under the Act, the Company will likely not be able to take
full advantage of these attributes for federal and state income tax purposes.
We
have
New Jersey NOL carryforwards in the approximate amount of $17,697,000, as
indicated above, and New Jersey research and development credits in the
approximate amount of $484,000, expiring through 2014 that are available to
reduce future earnings, which would otherwise be subject to state income tax.
For the year ended December 31, 2007, we sold approximately $2,988,000 of New
Jersey NOL carryforwards under a program of the New Jersey Economic Development
Authority (“NJEDA”). As of December 31, 2007, approximately $1,190,000 of these
New Jersey NOL carryforwards has been approved for future sale under the NJEDA
program. 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 consolidated financial statements
as specific sales are approved.
The
following is a reconciliation of the expected income tax benefit based on losses
from continuing operations before income taxes, computed at the U.S. Federal
statutory rate to the Company's actual income tax benefit:
|
|
|
December
31, 2007
|
|
|
December
31, 2006
|
|
Income
tax benefit at statutory rate
|
|
$
|
(3,695,369
|
)
|
$
|
(2,880,563
|
)
|
State
income taxes net of Federal tax
|
|
|
(652,124
|
)
|
|
(508,335
|
)
|
Nondeductible
expenses and prior year true-up
|
|
|
(77,356
|
)
|
|
299,628
|
|
Nondeductible
in-process research and development
|
|
|
385,290
|
|
|
|
|
Tax
credits
|
|
|
(352,002
|
)
|
|
(483,949
|
)
|
Sale
of state NOLs
|
|
|
(240,684
|
)
|
|
-
|
|
Increase
in valuation allowance
|
|
|
4,391,561
|
|
|
3,573,219
|
|
|
|
$
|
(240,684
|
)
|
$
|
-
|
|
The
Company files income tax returns in the U.S. federal and state jurisdictions.
With certain exceptions, the Company is no longer subject to U.S. federal and
state income tax examinations by tax authorities for years prior to 2004. The
Company adopted the provisions of FIN 48, Accounting
for Uncertainty in Income Taxes - an interpretation of FASB Statement No.
109,
on
January 1, 2007 with no material impact to the financial statements. The Company
had no unrecognized tax benefits during 2007 that would affect the annual
effective tax rate and no unrecognized tax benefits as of January 1, 2007 and
December 31, 2007. Further, the Company is unaware of any positions for which
it
is reasonably possible that the total amounts of unrecognized tax benefits
will
significantly increase or decrease within the next twelve months.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
NOTE
8 STOCKHOLDERS'
EQUITY (DEFICIENCY)
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 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
consolidated 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. On July 27, 2007, the Board approved an amendment
to
the Plan, increasing the number of shares available for grant to 7,500,000.
On
December 17, 2007, the Board approved an amendment to the Plan, increasing
the
number of shares available for grant to 13,500,000.
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.
Vesting
terms for the Company’s stock option plans differ based on the type of grant
made. Generally, stock options and warrants granted to employees and
non-employee directors vest as to one-third of the shares on each of the first,
second and third anniversaries of the grant date. However, vesting has ranged
in
length from immediate vesting to vesting periods in accordance with the period
covered by employment contracts. There were stock options to purchase 150,000
shares of common stock granted to a non-employee director in the first quarter
of 2006, of which 75,000 vested immediately and 75,000 vested on the first
anniversary of the grant date, stock options to purchase 400,000 shares of
common stock granted to four non-employee directors in the third quarter of
2007, of which one-third vested immediately and one-third of the shares vest
on
each of the first and second anniversaries of the grant date, stock options
to
purchase 5,013,343 shares of common stock granted to the President and Chief
Executive Officer, which vest as to 25% of the shares on each of the first,
second, third and fourth anniversaries of the grant date and stock options
to
purchase 856,440 shares of common stock granted to the President and Chief
Executive Officer, which will vest in four equal annual installments commencing
on the first anniversary of the grant date. However, this option is only
exercisable to the extent that the shares of the Company’s common stock held in
an escrow account in favor of the former stockholders of Greenwich Therapeutics,
Inc. in connection with the Company’s October 2005 acquisition of Greenwich are
released from escrow. As of December 31, 2007, 35% of the common stock held
in
escrow had been released and the Company has determined that it is probable
that
another 35% of the common stock held in escrow will be released by the June
30,
2008 deadline.
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.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
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, 2007
|
|
|
December
31, 2006
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
|
|
|
|
|
Exercise
|
|
|
|
|
|
Exercise
|
|
|
|
|
Shares
|
|
|
Price
|
|
|
Shares
|
|
|
Price
|
|
Outstanding
at beginning of year
|
|
|
5,384,807
|
|
$
|
0.99
|
|
|
4,273,227
|
|
$
|
1.07
|
|
Granted
|
|
|
7,295,783
|
|
$
|
0.49
|
|
|
1,746,580
|
|
$
|
0.73
|
|
Expired
|
|
|
(2,547,200
|
)
|
$
|
1.20
|
|
|
(635,000
|
)
|
$
|
0.89
|
|
Outstanding
at end of year
|
|
|
10,133,390
|
|
$
|
0.50
|
|
|
5,384,807
|
|
$
|
0.99
|
|
Options
exercisable at year-end
|
|
|
2,728,274
|
|
$
|
0.88
|
|
|
1,909,397
|
|
$
|
1.20
|
|
The
weighted-average fair value of options granted during the year was $0.47 and
$0.73 for the years ended December 31, 2007 and 2006, respectively.
The
Company has recorded $325,670 and $1,036,187 related to its employee share-based
expenses in selling, general and administrative expenses on the accompanying
Statements of Operations for the years ended December 31, 2007 and 2006,
respectively. The Company has recorded $114,132 and $3,958 employee share-based
research and development expenses on the accompanying Statements of Operations
for the year ended December 31, 2007 and 2006, respectively. The Company has
also recorded $65,277 and $83,523 non-employee share-based expenses related
to
stock options issued to consultants for the year ended December 31, 2007 and
2006, respectively. No compensation costs were capitalized as part of the cost
of an asset.
The
aggregate intrinsic value for options outstanding and exercisable at December
31, 2007 and 2006 was $0.00.
The
weighted average remaining contractual term for exercisable and non-exercisable
stock options was 7 years and 9 years respectively as of December 31, 2007
and 7
years and 8 years respectively as of December 31, 2006.
As
of
December 31, 2007, there was $2,159,598 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, 2007:
Range
of Exercise Prices
|
|
|
Outstanding
Options
|
|
|
Weighted
Average Exercise Price
|
|
|
Life
In Years
|
|
$.01-$0.49
|
|
|
6,253,115
|
|
$
|
0.30
|
|
|
10
|
|
$.50
- $0.99
|
|
|
3,432,275
|
|
$
|
0.75
|
|
|
4
|
|
$1.00-$1.49
|
|
|
335,000
|
|
$
|
1.12
|
|
|
6
|
|
$1.50-$1.99
|
|
|
113,000
|
|
$
|
1.70
|
|
|
3
|
|
Total
|
|
|
10,133,390
|
|
|
|
|
|
|
|
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 2007 and 2006:
|
|
December
31,
2007
|
|
December
31,
2006
|
|
Expected
lives
|
|
|
7
years
|
|
|
7
years
|
|
Expected
volatility
|
|
|
232%-277
|
%
|
|
210%-225
|
%
|
Dividend
yield
|
|
|
0
|
%
|
|
0
|
%
|
Risk-free
interest rate
|
|
|
4%-5
|
%
|
|
4
|
%
|
Forfeiture
rate
|
|
|
0%-26
|
%
|
|
19%-25
|
%
|
The
Company estimated the expected life of the options granted based on anticipated
exercises in future periods. To determine the expected stock price volatility,
the Company believes that the volatility calculated over the period since
becoming publicly traded over four 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. The expected dividend yield reflects the Company’s
current and expected future policy for dividends on its common stock. 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 forfeiture rate, the
Company estimated the forfeitability for three separate groups of non-vested
options: i) the recently appointed President & CEO; ii) the Company’s Board
of Directors; and iii) all other Company employees. For the President & CEO,
the Company determined a 0% forfeiture rate using qualitative measures. For
the
Company Board of Directors and all other employees, the Company believes that
its actual rate of forfeitures to date of 7% and 26%, respectively, is
reasonably indicative of future forfeitures. There were no stock options
exercised during the years ended December 31, 2007 and 2006.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
As
of
December 31, 2007, an aggregate of 3,366,610 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, 2007:
Remaining
Contractual Life In Years
|
|
Price
|
|
Number
of Outstanding Warrants
|
|
4.50
|
|
$
|
0.40
|
|
|
2,434,211
|
|
|
(A)
|
|
4.50
|
|
$
|
0.42
|
|
|
1,202,500
|
|
|
(B)
|
|
4.25
|
|
$
|
0.50
|
|
|
300,000
|
|
|
(C)
|
|
3.75
|
|
$
|
0.73
|
|
|
2,762,060
|
|
|
(D)
|
|
3.75
|
|
$
|
0.55
|
|
|
394,580
|
|
|
(E)
|
|
2.75
|
|
$
|
1.00
|
|
|
5,589,987
|
|
|
(F)
|
|
2.75
|
|
$
|
1.41
|
|
|
4,000,000
|
|
|
(G)
|
|
1.10
|
|
$
|
1.65
|
|
|
2,896,132
|
|
|
(H)
|
|
0.35
|
|
$
|
1.50
|
|
|
20,000
|
|
|
(I)
|
|
0.13
|
|
$
|
1.25
|
|
|
550,000
|
|
|
(J)
|
|
|
|
|
|
|
|
20,149,470
|
|
|
|
|
(A) |
-
Warrants issued as a result of the Company’s June 29 and July 3, 2007
issuance of convertible promissory notes to investors. All warrants
are
exercisable as of December 31,
2007.
|
(B) |
-
Warrants issued as a result of the Company’s June 29 and July 3, 2007
issuance of convertible promissory notes to placement agents. All
warrants
are exercisable as of December 31,
2007.
|
(C) |
-
Warrants issued as a result of the Xyfid license agreement. In connection
with the agreement, two-thirds of the warrants are exercisable upon
the
achievement of certain clinical milestones. One-third of the warrants
are
exercisable as of December 31,
2007.
|
(D) |
-
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, 2007.
|
(E) |
-
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,
2007.
|
(F) |
-
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,
2007.
|
(G) |
-
Warrants issued as a result of the merger with Greenwich. Based upon
the
terms of the merger agreement, one-half of the warrants were immediately
exercisable, and one-half are exercisable upon the achievement of
certain
clinical milestones (see Note 4). As of December 31, 2007, there
are
2,700,001 merger warrants that are
exercisable.
|
(H) |
-
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,
2007.
|
(I) |
-
Warrants issued as a result of the lease agreement between Chiral
Quest,
Inc. and Princeton Corporate Plaza in May 2003. All warrants are
exercisable as of December 31,
2007.
|
(J) |
-
Warrants issued as a result of the merger by and among Surg II, Inc.,
Chiral Quest, LLC and CQ Acquisition Corp. in February 2003. All
warrants
exercisable as of December 31,
2007.
|
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
NOTE
9 COMMITMENTS
AND CONTINGENCIES
(A)
EMPLOYMENT AGREEMENTS AND SEPARATION AGREEMENT
Appointment
of President and Chief Executive Officer
In
November 2007, the Company and Michael D. Becker entered into an Employment
Agreement (the “Employment Agreement”) whereas Mr. Becker serves as the
Company’s President and Chief Executive Officer, effective November 21, 2007.
Mr. Becker was also appointed to the Company’s Board of Directors effective as
of such date. The Employment Agreement provides for a term of 4
years.
Under
the
Employment Agreement, Mr. Becker is entitled to an annualized base salary of
$358,400, plus cash bonuses payable as follows:
· |
A
bonus of $150,000 payable when the Company receives gross proceeds
from
the sale of its securities in one or a series of related
transactions;
|
· |
A
bonus of $125,000 payable when the Company’s aggregate market
capitalization (determined by multiplying the closing sale price
of the
Company’s common stock by the number of shares issues and outstanding at
a
given time) exceeds $125 million for a period of 15 consecutive trading
days.
|
· |
A
bonus of $500,000 payable when the Company’s aggregate market
capitalization (determined by multiplying the closing sale price
of the
Company’s common stock by the number of shares issues and outstanding at
a
given time) exceeds $250 million for a period of 15 consecutive trading
days.
|
· |
A
bonus of $1,000,000 payable when the Company’s aggregate market
capitalization (determined by multiplying the closing sale price
of the
Company’s common stock by the number of shares issues and outstanding at
a
given time) exceeds $500 million for a period of 15 consecutive trading
days.
|
· |
A
bonus of $2,000,000 payable when the Company’s aggregate market
capitalization (determined by multiplying the closing sale price
of the
Company’s common stock by the number of shares issues and outstanding at
a
given time) exceeds $1 billion for a period of 15 consecutive trading
days.
|
In
addition, the Employment Agreement provides that the Company granted to Mr.
Becker two stock options pursuant to the Company’s 2003 Stock Option Plan. The
first stock option grant provided Mr. Becker with the right to purchase
5,013,343 shares of the Company’s common stock at a price equal to the closing
sale price of the common stock on November 21, 2007 (the “Initial Option”). The
Initial Option has a 10-year term and will vest in four equal annual
installments commencing on the first anniversary of Mr. Becker’s employment
commencement date, or November 21, 2008. The second option provided Mr. Becker
with the right to purchase 856,440 shares of the Company’s common stock at a
price equal to the closing sale price of the common stock on November 21, 2007
(the “Merger Option” and together with the Initial Option, the “Stock Options”).
The Merger Option also has a 10-year term and will vest in four equal annual
installments commencing on the first anniversary of Mr. Becker’s commencement
date. However, the Merger Option is only exercisable to the extent that the
shares of the Company’s common stock currently held in an escrow account in
favor of the former stockholders of Greenwich Therapeutics, Inc. in connection
with the Company’s October 2005 acquisition of Greenwich are released from
escrow. The Employment Agreement further provides that Mr. Becker is eligible
to
receive additional stock options beginning on the second anniversary of the
agreement, at the discretion of the Board.
Separation
Agreement with Former Chief Executive Officer
On
November 14, 2007, the Company and Daniel Greenleaf, the Company’s former
President and Chief Executive Officer, entered into a Separation and Release
Agreement (the “Separation Agreement”). Pursuant to the Separation Agreement,
the parties mutually agreed that Mr. Greenleaf’s employment with the Company
terminated as of November 9, 2007, and that Mr. Greenleaf resigned from all
positions as officer and director of the Company. The Separation Agreement
provides for the following compensation to be paid to Mr. Greenleaf: (i) Mr.
Greenleaf was entitled to receive his annualized base salary of $360,000 through
November 15, 2007; (ii) Mr. Greenleaf will receive his annualized base salary
of
$360,000 for a period of 6 months commencing on or about May 10, 2008; (iii)
Mr.
Greenleaf will receive a lump sum payment of $70,000 payable on or before March
31, 2008; and (iv) the Company will reimburse Mr. Greenleaf for health insurance
for a period of up to 12 months. Under the Separation Agreement, the parties
agreed to release each other from certain legal claims, known or unknown, as
of
the date of the agreement, and the Company also released Mr. Greenleaf from
the
covenant not to compete contained in his employment agreement with the Company
dated February 1, 2005. As of December 31, 2007, the Company accrued $284,605
for 6 months of salary and the bonus payment plus related payroll taxes as
well
as 12 months of health insurance costs.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
Appointment
of Chief Scientific and Medical Officer
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, subject to a ten-year term; 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.
(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 on January 6, 2012.
In
connection with the sale of the Company’s Chiral Quest Subsidiary, on July 16,
2007, the Company entered into a sublease agreement with CQAC, which purchased
Chiral Quest, to lease office and laboratory space in Monmouth Junction, New
Jersey used in Chiral Quest’s business. The sublease agreement provides for a
term that will expire on May 30, 2008. CQAC agreed to make all payments of
base
rent and additional rent that the Company is obligated to pay under its lease
agreement for such space. If CQAC were to default on payment during the sublease
agreement’s term, the Company would be obligated to provide payment to its
landlord on behalf of CQAC through the remainder of the original lease term,
and
the Company will have the right to cancel and terminate the sublease with CQAC
upon 5 days notice to subtenant. To date, CQAC has fully complied with the
sublease agreement with the Company.
Future
minimum rental payments subsequent to December 31, 2007 for operations are
as
follows:
Years
ended
December
31,
|
|
Continuing
Operations
|
|
Discontinued
Operations
|
|
Total
|
|
2008
|
|
$
|
102,000
|
|
|
-
|
|
|
102,000
|
|
2009
|
|
|
102,000
|
|
|
-
|
|
|
102,000
|
|
2010
|
|
|
106,000
|
|
|
-
|
|
|
106,000
|
|
2011
|
|
|
106,000
|
|
|
-
|
|
|
106,000
|
|
2012
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Total
|
|
$
|
416,000
|
|
|
-
|
|
|
416,000
|
|
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
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, 2007 and 2006 was approximately $99,000 and $50,000,
respectively.
NOTE
10 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 Lenocta. We
are
obligated to make an annual license maintenance payment until the first
commercial sale of Lenocta, 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. In November 2007, the Company
achieved a milestone obligation to CCF, from the dosing of our first
patient in our Phase IIa clinical trial. To date, the Company has not fulfilled
its payment obligation of $300,000 to CCF relating to this milestone. Should
Lenocta 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 Lenocta
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 Lenocta and have the obligation to use all
commercially reasonable efforts to bring Lenocta to market. We have agreed
to
prosecute and maintain the patents associated with Lenocta 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.
(“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.
License
with Asymmetric Therapeutics, LLC and Onc Res, Inc., assigned by Fiordland
Pharmaceuticals, Inc.
On March
29, 2007, the Company entered into an exclusive license agreement with
Asymmetric Therapeutics, LLC, or Asymmetric, and Onc Res, Inc., or Onc Res,
as
assigned by Fiordland Pharmaceuticals, Inc., or Fiordland. The agreement is
for
the rights to develop, manufacture, use, commercialize, lease, sell and/or
sublicense Xyfid. In consideration for the rights under the license agreement,
the Company paid to the licensor an aggregate $300,000 for license related
fees,
and $37,000 for patent prosecution costs. In addition, the Company paid to
a
third party finder a cash fee of $20,000 and a 5-year warrant to purchase
300,000 shares of the Company’s common stock at an exercise price of $0.50 per
share. The right to purchase the shares under the warrant vests in three equal
installments of 100,000 each, with the first installment being immediately
exercisable, and the remaining two installments vesting upon the achievement
of
certain clinical development and regulatory milestones relating to Xyfid. The
Company has recognized approximately $50,000 of expense in the first quarter
of
2007 based upon the immediate vesting of the first 100,000 options. In
consideration of the license, the Company is required to make payments upon
the
achievement of various clinical development and regulatory milestones, which
total up to $6.2 million in the aggregate. The license agreement further
requires the Company to make payments of up to an additional $12.5 million
in
the aggregate upon the achievement of various commercialization and net sales
milestones. The Company will also be obligated to pay a royalty on net sales
of
the licensed product. We have agreed to prosecute and maintain the patents
associated with Xyfid or provide notice to Asymmetric and/or Onc Res 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
Asymmetric, 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, 2007 AND 2006
NOTE
11 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, 2007 or 2006.
NOTE
12 CERTAIN
TRANSACTIONS
On
June
29, 2007 and July 3, 2007, the Company issued and sold a series of 8%
convertible promissory notes (the “Bridge Notes”) in the aggregate principal
amount of $3,700,000 with a term of one year from the date of final closing.
In
connection with the Bridge Notes, the Company engaged Paramount as one of its
placements agents. Dr. Lindsay A. Rosenwald is the Chairman, CEO and sole
stockholder of Paramount and a substantial stockholder of the Company. Stephen
C. Rocamboli, a director of the Company, was employed by Paramount at the time
of the Company’s engagement. Of the total consideration provided to the
placement agents, the Company issued warrants to Paramount to purchase 450,000
shares of common stock at a price of $0.42 per share and paid commissions of
approximately $119,700. Based on the Black-Scholes option pricing model, the
warrants are valued at approximately $160,865.
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 model, the investor warrants are 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.
In
August
2006, the Company entered into a consulting agreement through the end of October
2006 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, 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.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND 2006
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. As of December 31, 2007,
2,997,540 shares of the Company’s common stock and five-year warrants to
purchase an additional 700,001 shares of the Company’s common stock have been
released from escrow and issued to Greenwich (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 ).
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 satisfied the final portion of debt and accrued
interest in July 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 was
employed by Paramount until August 2007 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.
NOTE
13 SUBSEQUENT
EVENTS
On
September 12, 2007, the Company’s shareholders approved an amendment to the
Company’s charter increasing the number of authorized shares of common
stock, par
value
$0.001 per share, to 200 million. On January 25, 2008, the Company’s Certificate
of Incorporation was amended by the State of Delaware adopting the increase
in
the total number of shares authorized.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007 AND
2006
On
March
14, 2008, we issued 765 shares of Series A Convertible Preferred Stock at a
price of $1,000 per share resulting in aggregate gross proceeds of $765,000.
Each
share of Series A Convertible Preferred Stock sold is convertible into shares
of
the Company's Common Stock at $0.10 per share, or approximately 7.65
million shares of Common Stock in the aggregate. We
also
issued to investors five-year warrants to purchase an aggregate of
approximately 3.8 million shares of our common stock at an exercise price
of $0.17 per share. Based upon the Black-Scholes option pricing model, the
investor warrants are estimated to be valued at approximately $420,000. In
connection with the offering, we engaged Paramount as our placement agent.
Dr.
Lindsay A. Rosenwald is the Chairman, CEO and sole stockholder of Paramount
and
a substantial stockholder of the Company. Dr. Rosenwald participated in this
financing, through a family investment partnership, of which he is the managing
member. In consideration for the placement agent's services, we paid an
aggregate of approximately $54,000 in commissions to Paramount in connection
with the offering. We also paid to Paramount $35,000 as a non-accountable
expense allowance. In addition, we issued to Paramount five-year warrants to
purchase an aggregate of approximately 765,000 shares of common stock, which
are
exercisable at a price of $0.14 per share. Based upon the Black-Scholes option
pricing model, the warrants issued to Paramount are estimated to be
valued at approximately $84,000.
The
Series A Convertible Preferred Stock shall be entitled to an annual dividend
equal to 6% of the applicable issuance price per annum, payable semi-annually
in
cash or shares of common stock, at the option of the Company. If the Company
chooses to pay the dividend in shares of common stock, the price per share
of
common stock to be issued shall be equal to 90% of the average closing price
of
the common stock for the 20 trading days prior to the date that such dividend
becomes payable. As
a
condition to the initial closing of the private placement, the majority of
the
holders of the June 29, 2007 and July 3, 2007 convertible promissory notes
agreed to convert such notes, together with accrued interest, into approximately
3,910 shares of the Company’s newly-designated Series B Convertible Preferred
Stock. The Series B Convertible Preferred Stock contain substantially the
same economic terms as the previously outstanding senior convertible
notes.
Exhibit
No.
|
|
Description
|
|
|
|
|
|
3.1
|
|
|
Certificate
of Incorporation, as amended to date.
|
|
10.1
|
|
|
2003
Stock Option Plan, as amended.
|
|
10.14
|
|
|
Employment
Agreement between the Registrant and Michael D. Becker dated November
11,
2007.
|
|
10.16
|
|
|
Separation
and Release Agreement between the Registrant and Daniel Greenleaf
dated
November 14, 2007.
|
|
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.
|
|