As
filed with the Securities and Exchange Commission
on August 5, 2008
Registration
No. 333-151115
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
PRE-EFFECTIVE
AMENDMENT NO. 2
TO
FORM
S-1
REGISTRATION
STATEMENT UNDER
THE
SECURITIES ACT OF 1933
VioQuest
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
(State
or jurisdiction
of
incorporation or organization)
|
2834
(Primary
Standard Industrial
Classification
Code Number)
|
58-1486040
(I.R.S.
Employer
Identification
No.)
|
|
|
|
180
Mount Airy Road, Suite 102
Basking
Ridge, NJ 07920
(Address
and telephone number of principal executive offices and principal
place of
business)
|
|
Michael
D. Becker
Chief
Executive Officer
VioQuest
Pharmaceuticals, Inc.
180
Mount Airy Road, Suite 102
Basking
Ridge, NJ 07920
Telephone:
(908)
766-4400
Facsimile:
(
908)
766-4455
(Name,
address and telephone number of agent for service)
|
|
Copies
to:
William
M. Mower, Esq.
Maslon
Edelman Borman & Brand, LLP
90
South 7th Street, Suite 3300
Minneapolis,
Minnesota 55402
Telephone:
(612) 672-8200
Facsimile:
(612) 672-8397
|
Approximate
date of commencement of proposed sale to the public:
As soon
as practicable after the effective date of this registration
statement.
If
any of
the securities being registered on this Form are to be offered on a delayed
or
continuous basis pursuant to Rule 415 under the Securities Act of 1933,
check the following box.
x
If
this
Form is filed to register additional securities for an offering pursuant to
Rule 462(b) under the Securities Act, check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering.
o
If
this
Form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering.
o
If
this
Form is a post-effective amendment filed pursuant to Rule 462(d) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering.
o
Indicate
by check mark whether the registrant is a large accelerated filed, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of “large accelerated filed,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act (Check one):
Large accelerated filer
o
|
Accelerated filer
o
|
Non-accelerated filer
o
|
Smaller reporting company
x
|
The
registrant hereby amends this registration statement on such date or dates
as
may be necessary to delay its effective date until the registrant shall file
a
further amendment which specifically states that this registration statement
shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of 1933 or until this registration statement shall become
effective on such date as the Commission, acting pursuant to such
Section 8(a), may determine.
A
registration statement relating to these securities has been filed with the
Securities and Exchange Commission. These securities may not be sold nor may
offers to buy be accepted prior to the time the registration statement becomes
effective. This prospectus shall not constitute an offer to sell or the
solicitation of an offer to buy nor shall there be any sale of these securities
in any state in which such offer, solicitation or sale would be unlawful prior
to registration or qualification under the securities laws of any such
state.
Subject
to completion, dated August 5, 2008
OFFERING
PROSPECTUS
VioQuest
Pharmaceuticals, Inc.
1,307,581
Shares
Common
Stock
The
selling stockholders identified on pages 19-20 of this prospectus are
offering on a resale basis a total of 1,307,581 shares of our common stock,
including 482,754 shares issuable upon the exercise of outstanding warrants.
We
will not receive any proceeds from the sale of these shares by the selling
stockholders.
Our
common stock is quoted on the OTC Bulletin Board under the symbol “VOQP.” On
August 4, 2008, the last sale price for our common stock as reported on the
OTC
Bulletin Board was $ 0.51.
The
securities offered by this prospectus involve a high degree of
risk.
See
“Risk Factors” beginning on page 12.
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved of these securities or determined that this prospectus
is truthful or complete. A representation to the contrary is a criminal
offense.
The
date
of this Prospectus
is ,
2008.
TABLE
OF CONTENTS
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Page
|
Prospectus
Summary
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4
|
Description
of Private Placement of Preferred Stock
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9
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Risk
Factors
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12
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Note
Regarding Forward Looking Statements
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18
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Use
of Proceeds
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18
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Selling
Stockholders
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19
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Prior
Transactions between the Company and the Selling Shareholders
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21
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Plan
of Distribution
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24
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Description
of Capital Stock
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26
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
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30
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Description
of Business
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43
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Management
and Board of Directors
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56
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Security
Ownership of Certain Beneficial Owners and Management
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67
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Transactions
with Related Persons, Promoters and Certain Control
Persons
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68
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Material
Changes
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69
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Where
You Can Find More Information
|
|
Validity
of Common Stock
|
|
Experts
|
|
Disclosure
Of Commission Position On Indemnification For Securities Act
Liabilities
|
|
Financial
Statements
|
F-1
|
PROSPECTUS
SUMMARY
This
summary provides a brief overview of the key aspects of this offering. Because
it is only a summary, it does not contain all of the detailed information
contained elsewhere in this prospectus or in the documents included as exhibits
to the registration statement that contains this prospectus. Accordingly, you
are urged to carefully review this prospectus in its entirety.
Our
Company
Product
Pipeline
VioQuest
Pharmaceuticals, Inc. is 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 we filed our 510(k) Premarket Notification
application with the U.S. Food and Drug Administration (“FDA”) on June 30, 2008,
seeking marketing clearance 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 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.
Xyfid™
(1% Topical Uracil)
A
pilot
clinical study of seven patients has shown topical application of Xyfid to
patients’ hands and feet to be effective in preventing the recurrence of
HFS, the dose limiting effect from the use of Xeloda™ (capecitabine or 5-FU).
The FDA has granted Xyfid fast track designation for the prevention of HFS
in
patients receiving capecitabine for the treatment of advanced metastatic breast
cancer. There are no existing treatments or preventions for HFS. The only way
to
reduce HFS in patients who receive capecitabine or 5-FU is to lower the dosing
levels, or completely stop the use, of capecitabine; however, capecitabine
dose
reductions may diminish chemotherapeutic efficacy in the treatment of
life-threatening cancer. We expect to initiate a Phase IIb program for Xyfid™ in
the first half of 2008.
We
are
pursuing FDA approval of Xyfid as a medical device pursuant to Section 510(k)
of
the Food Drug and Cosmetic Act, or FDCA, and have submitted our 510(k)
application on June 30, 2008. 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 pre-market approval, or PMA 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. 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 PMA approval application.
We
filed
our 510(k) submission based upon our belief that both Epiceram® and Xclair®
provide substantial predicate device equivalence in order for the FDA to
grant
510(k) clearance for Xyfid. Our strategy with Xyfid is based upon the same
skin
irritant indication as Epiceram®, where we can use our uracilbased product to
treat the initial symptoms of HFS, to act as a barrier or protectant to the
skin’s environment, which is well documented to include erythema and may
progress to burning pain with dryness, cracking, desquamation, ulceration
and
oedema. By regulation, the FDA is required to complete its review of a 510(k)
within 90 days of submission of the application. As a practical matter, however,
clearance often takes longer. The FDA may require additional information,
including clinical data, to make a determination regarding substantial
equivalence. If we are not successful in obtaining 510(k) clearance for Xyfid,
our regulatory strategy for Xyfid would be the more conventional pathway
for
pharmaceutical products under the FDCA.
VQD-002
(tricirbine phosphate monohydrate)
We
are
currently evaluating VQD-002 in patients with hyper-activated,
phosphorylated AKT in two Phase I/IIa studies,
with
up
to 42 patients at the Moffitt Cancer Center in solid tumors and at the M.D.
Anderson Cancer Center in hematological tumors, with particular attention in
leukemias.
We
expect to complete our Phase I/IIa solid and hematologic tumor studies in 2008.
We expect to initiate Phase II studies in 2008. VQD-002 is a nucleoside analog
that was previously advanced into clinical trials by the National Cancer
Institute in the 1980s and early 1990s, and showed compelling anti-cancer
activities. In the first quarter of 2008, VQD-002 received orphan drug
designation by the FDA for the treatment of multiple myeloma. We filed with
the
FDA an IND relating to VQD-002, which was accepted in April 2006. Pursuant
to
this IND, we are currently evaluating the safety, tolerability and activity
of
VQD-002 and its ability to reduce AKT phosphorylation in our two Phase I/IIa
clinical trials.
Lenocta™
(sodium stibogluconate)
We
are
currently evaluating Lenocta in combination with alpha interferon (“IFN
a
-2b”)
in
a Phase IIa study, with up to 54-patients at the M.D. Anderson Cancer Center
and
the University of New Mexico, with advanced malignancies and solid tumors that
have been non-responsive in previous cytokine therapy. We expect to complete
enrollment in our Phase IIa solid tumor trial in 2008. Lenocta has shown to
be
an inhibitor of multiple protein tyrosine phosphatases (PTPases), specifically
the SRC homology PTPases such as SHP-1, SHP-2 and PTP1B. We filed with the
FDA
an IND for Lenocta, which the FDA accepted in August 2006, allowing us to
commence clinical trials of Lenocta. Potential advantages of Lenocta over
existing therapies include Lenocta’s long history of use, acceptable toxicity,
known safety profiles, and efficacy in preclinical cancer models.
Lenocta
is a pentavalent antimonial drug that has been in use for over 50 years in
parts
of Africa and Asia for the treatment of leishmaniasis (a protozoan disease).
According to the World Health Organization, leishmaniasis currently threatens
350 million men, women, and children in 88 countries around the world. This
drug
is currently being used to treat military personnel serving in parts of the
world where leishmaniasis is prevalent, and we are currently in collaboration
with the U.S. Army under an executed Cooperative Research and Development
Agreement. In the second half of 2006, Lenocta received orphan drug designation
by the FDA for the treatment of leishmaniasis.
Overview
of Drug Development Status
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.
Assuming
we do not encounter any unforeseen safety issues or other during the course
of
developing our product candidates, we do not expect to complete the development
of: Xyfid until approximately 2008 through a 510(k) submission, 2010 for Xyfid
through an NDA submission, and 2013 for oncology indications of VQD-002 and
Lenocta, if ever. In addition, as we continue the development of our product
candidates, our research and development expenses will significantly increase.
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.
Corporate
Information
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, we sold all of our shares of capital stock of our 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.
Lenocta™
is our trademark for our sodium stibogluconate product candidate. Xyfid™ is the
trademark for our topical uracil product candidate. All other trademarks and
tradenames mentioned in this prospectus are the property of their respective
owners. We have applied for rights to the Lenocta and Xyfid trademarks
from the U.S. Patent and Trademark Office.
Our
executive offices are located at 180 Mount Airy Road, Suite 102, Basking Ridge,
New Jersey 07920 and our telephone number is (908) 766-4400. Our Internet site
is
www.vioquestpharm.com
.
Risk
Factors
For
a
discussion of some of the risks you should consider before purchasing shares
of
our common stock, you are urged to carefully review and consider the section
entitled “Risk Factors” beginning on page 12 of this
prospectus.
The
Offering
This
prospectus covers the resale of 1,307,581 shares of our common stock. Because
of
the large number of shares of our common stock underlying our Series A
Convertible Preferred Stock, Series B Convertible Preferred Stock, and
related
investor warrants and placement agent warrants, we are only registering
the
number of shares equal to one-third of the shares of our common stock held
by
non-affiliates prior to the offering of our Series A Convertible Preferred
Stock. Thus, we proportionally reduced the number of shares of common stock
underlying our Series A Convertible Preferred Stock, the warrants received
by
investors purchasing our Series A Convertible Preferred Stock, and the
warrants
issued to the placement agents in conjunction with the offering of our
Series A
Convertible Preferred Stock.
The
total
dollar value of the common stock being registered for resale pursuant to
this
prospectus is $1,307,581, as determined by the market price of our common
stock
on April 9, 2008. The total dollar value of the shares of common stock
underlying the Series A Convertible Preferred Stock is $824,827 and the
aggregate dollar value of the shares of common stock underlying the investor
warrants and placement agent warrants is $482,754.
The
selling stockholders identified on pages 19-20 of this prospectus are
offering on a resale basis a total of 1,307,581 shares of our common stock,
as
follows:
·
|
824,827
shares of our common stock underlying shares of our Series
A Convertible
Preferred Stock convertible at a price of $0.60 per share issued
to the
investors in our private placement of Series A Convertible
Preferred
stock;
|
·
|
437,412
shares of our common stock issuable at a price of $1.00 per
share upon the
exercise of warrants issued to the investors in our private
placement of
Series A Convertible Preferred stock;
and
|
·
|
45,342
shares of our common stock issuable at a price of $0.80 per
share upon the
exercise of warrants issued to the placement agents in connection
with our
private placement of Series A Preferred
Stock.
|
Common
stock offered
|
1,307,581
shares
|
Common
stock outstanding before the offering(1)
|
5,461,644
shares
|
Common
stock outstanding after the offering(2)
|
6,769,225 shares
|
Common
Stock OTC Bulletin Board symbol
|
VOQP.OB
|
______________
|
(1)
|
Based
on the number of shares outstanding as of July 30, 2008, not
including
3,467,882 shares issuable upon exercise of various warrants and
options to
purchase common stock, or 3,743,196 shares issuable upon exercise
of
warrants issued in connection with Series A Preferred Stock and
Series B
Preferred Stock
or
5,774,167 shares of Common Stock issuable upon conversion of
Series A
Convertible Preferred Stock or 896,096 shares of Common Stock
issuable
upon conversion of Series B Convertible Preferred Stock.
.
|
|
(2)
|
Assumes
the issuance of all shares offered hereby that are issuable upon
exercise
of warrants
and
upon conversion of the Series A Convertible Preferred Stock
,
but does not include shares not covered by this
prospectus.
|
As
of the
date of this prospectus, none of the shares of common stock underlying our
Series A Convertible Preferred Stock, Series B Convertible Preferred Stock,
investor warrants, or placement agent warrants have been issued or are
outstanding.
Recent
Developments
Appointment
of Chief Financial Officer
On
July
21, 2008, we hired Christopher P. Schnittker as our Chief Financial Officer
and
Vice President. Mr. Schnittker replaced Brian Lenz who resigned his office
as
Chief Financial Officer on July 21, 2008. Mr. Schnittker previously served
as
Senior Vice President and Chief Financial Officer of Micromet, Inc. We entered
into an employment agreement with Mr. Schnittker with a two-year term and
a base
salary of $185,000. We granted Mr. Schnittker stock options and he is eligible
to receive bonuses as described below in “Executive Compensation –
Employment Agreements with Named Executives – Christoper
Schnittker.”
Amendment
of Escrow Agreement
On
July
8, 2008, we amended our escrow agreement with J. Jay Lobell, as stockholders’
representative, U.S. Bank National Association, as the escrow agent, and
Greenwich Therapeutics, Inc., to extend the termination date for the escrow
agreement until June 30, 2009. The amendment was made effective as of June
30,
2008, and replaced the original escrow termination Date of the same date.
All
other obligations set forth in the original escrow agreement remain in full
force and effect. We previously filed a current report on Form 8-K on July
10,
2008 disclosing the amendment of the escrow agreement.
Reverse
Stock Split
On
April
25, 2008, we effected a 1-for-10 reverse stock split of our common stock. Upon
the effective time of the split, each shareholder owning 10 shares of pre-split
common stock received 1 share of post-split common stock. In lieu of fractional
shares, each record holder of securities at the effective time, who would
otherwise have been entitled to receive a fractional security is entitled to,
upon surrender of such holder's certificates representing pre-split securities,
a cash payment (without interest). Pursuant to the reverse stock split, all
of
our warrants, options, and conversion ratios were adjusted accordingly. Unless
otherwise noted in this prospectus, all of the figures for the number of
outstanding shares of common stock and shares of common stock underlying
preferred stock, warrants, and options contained herein have been adjusted
to
reflect the 1-for-10 reverse split.
Note
Offering
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. As a condition to
the
initial closing of the private placement of our Series A Convertible Preferred
Stock, a majority of the principal amount outstanding under these notes
agreed
to convert all principal, together with accrued interest, into approximately
3,405 shares of our newly-designated Series B Convertible Preferred Stock.
The
holders agreed to amend the notes to affect the conversion into Series
B
Convertible Preferred Stock so that we could conduct the initial closing
of our
offering and receive financing necessary to continue the development of
our
products and operations. Each share of Series B Convertible Preferred Stock
is
convertible into shares of our common stock at $3.80 per share, or approximately
896,096 shares of common stock in the aggregate.
Placement
Agent Commission and Fees
In
connection with our offering of our convertible promissory notes, we paid
an
aggregate of approximately $256,000 in placement agent commissions to all
of the
placement agents, including $119,700 to Paramount BioCapital, Inc. We also
paid
the placement agents approximately $24,000 as non-accountable expense allowance
and we issued the placement agent’s five-year warrants to purchase as adjusted
for the 1-for-10 reverse stock, an aggregate of approximately 120,000 shares
of
common stock exercisable at a price of $4.20 per share.
Officer
and Director Participation
Brian
Lenz, our former Chief Financial Officer, and Michael Weiser, one of our
directors, both invested in our offering of senior convertible promissory
notes
in June and July 2007. Mr. Lenz was issued a senior convertible promissory
note
in the amount of $5,000. Mr. Weiser was issued a senior convertible promissory
note in the amount of $10,000. Please refer to “Description of Private Placement
of Preferred Stock - Conversion of Notes Held by Officers and Directors” for
more information.
Offering
of Preferred Stock
On
March
14, and April 9, 2008 we closed on our private placement of our Series A
Convertible Preferred Stock. We issued an aggregate of 3,464.5 shares of
our
Series A Convertible Preferred Stock to our investors, along with five year
warrants to purchase an aggregate of 2.88 million shares of our common stock
at
a price of $1.00 per share. We engaged Paramount BioCapital, Inc., as our
placement agent and paid Paramount a commission of $54,000 and a reimbursement
for fees. Please refer to “Description of Private Placement of Preferred Stock”
below for more information about the offering.
A
description of the rights of the Series A Convertible Preferred Stock and
the
Series B Convertible Preferred Stock may be found below under “Description of
Capital Stock.”
DESCRIPTION
OF PRIVATE PLACEMENT OF PREFERRED STOCK
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.
On
April 9, 2008, we issued 2,194.5 shares of Series A Convertible Preferred
Stock
at a price of $1,000 per share resulting in aggregate gross proceeds of
$2,194,500, and reissued the shares originally issued on March 14, 2008,
for
total gross proceeds of $2,959,500. Each share of Series A Convertible
Preferred
Stock sold is convertible into shares of our common stock at $0.60 per
share, or
approximately 4.93 million shares of common stock in the aggregate. In
addition,
two investors elected to convert a portion of the principal and unpaid
but
accrued interest of their note into 505 shares of Series A Convertible
Preferred
Stock on the same terms as their purchase of Series A Convertible Preferred
Stock. We also issued to investors five-year warrants to purchase an aggregate
of approximately 2.88 million shares of our common stock at an exercise
price of
$1.00 per share. The Series A Preferred Stock was sold to 35 investors,
each of
which we reasonably believed was an “accredited investor,” as defined under Rule
501(a) of the Securities Act of 1933, and no means of general solicitation
or
advertising was used in connection with the offering. Accordingly, we relied
on
the exemptions from the registration requirements of the Securities Act
provided
by Section 4(2) and Rule 506.
Placement
Agent Commission and Fees
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 holder of our stock. 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 492,416 shares
of
common stock, which are exercisable at a price of $0.80 per share. Dr.
Rosenwald
participated in this financing, through a family investment partnership,
of
which he is the managing member.
Total
Potential Investor Profit From Preferred Stock
The
table
below sets forth the total possible investor profit arising from the private
placement of our Series A Convertible Preferred Stock on April 9, 2008.
As
stated in the table, the investors purchasing our Series A Convertible
Preferred
Stock received an aggregate discount of $1,154,833.40 from the market price
of
our common stock on April 8, 2008.
Series
A Convertible Preferred Stock
|
Market Price of
Common Stock
on April 8,
2008*
|
|
Fixed
Conversion
Price of Series
A Stock
|
|
Total Number of
Shares of Common
Stock Underlying
Series A Stock
|
|
Total Market Price of
Shares Underlying
Series A Stock
|
|
Aggregate
Conversion Price
of Shares at Fixed
Conversion Price
|
|
Total Discount
for Series A
Purchasers
|
|
$
|
0.80
|
|
$
|
0.60
|
|
|
5,774,167
|
|
$
|
4,619,333.60
|
|
$
|
3,464,500.20
|
|
$
|
1,154,833.40
|
|
*
The
final closing of the Series A Convertible Preferred Stock private placement
occurred on April 9, 2008.
The
table
below sets froth the total possible investor profit arising from the conversion
of our senior convertible promissory notes into shares our Series B Convertible
Preferred Stock on March 14, 2008.
Series
B Convertible Preferred Stock
|
Market Price of
Common Stock
on March 13,
2008*
|
|
Fixed
Conversion
Price of Series
B Stock
|
|
Total Number of
Shares of Common
Stock Underlying
Series B Stock
|
|
Total Market Price of
Shares Underlying
Series B Stock
|
|
Aggregate
Conversion Price
of Shares at Fixed
Conversion Price
|
|
Total Premium
for Series B
Purchasers
|
|
$
|
0.80
|
|
$
|
3.80
|
|
|
896,096
|
|
$
|
716,876.80
|
|
$
|
3,405,164.80
|
|
$
|
2,688,288
|
|
*
The
Company issued the shares of Series B Convertible Preferred Stock upon
the
conversion of its senior convertible promissory notes on March 14,
2008.
Summary
of Proceeds
The
following table sets forth both our gross and net proceeds from the private
placement of our Series A Convertible Preferred Stock on April 9, 2008,
as well
as our net proceeds less the aggregate discount for the investors purchasing
our
Series A Convertible Preferred Stock.
Aggregate Gross
Proceeds
|
|
Placement Agent Fees
and Commissions
|
|
Aggregate Net
Proceeds to Company
|
|
Total Discount for
Series A Purchasers
|
|
Net Proceeds Less
Total Discount for
Series A Purchasers
|
|
$
|
2,959,500
|
|
$
|
242,000
|
|
$
|
2,717,500
|
|
$
|
1,154,833.40
|
|
$
|
1,562,666.60
|
|
All
of
our senior convertible promissory notes were converted into shares of Series
B
Convertible Preferred Stock on March 14, 2008, thus we did not receive
any
proceeds upon the issuance of its Series B Convertible Preferred Stock.
However,
we did receive proceeds upon the original issuance of our senior convertible
preferred notes on June 27, 2007 and July 3, 2007. Please note that the
conversion price of the senior convertible preferred notes did not contain
a
discount provision.
Senior
Convertible Promissory Notes
|
Aggregate Gross Proceeds
|
|
Placement Agent Fees and Commissions
|
|
Aggregate Net Proceeds to Company
|
|
$
|
|
|
$
|
256,025
|
|
$
|
3,443,975
|
|
Other
Information
We
do not
have any information that states any of the selling shareholders have existing
short positions on our common stock.
Rule
415 and Registration of Shares for Resale
We
are
only able to register a portion of the shares of common stock underlying
our
Series A Convertible Preferred Stock and related investor and placement
agent
warrants because of Rule 415. Pursuant to the SEC's application of
Rule 415, we
are only able to register shares equal to one-third of the shares of
common
stock held by non-affiliates prior to this offering. Thus, this prospectus
covers 1,307,581 shares of our common stock underlying our Series A
Convertible
Preferred Stock, investor warrants, and placement agent
warrants.
Conversion
of Promissory Notes and Issuance of Series B Convertible Preferred
Stock
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
3,410 shares of our newly-designated Series B Convertible Preferred Stock.
The
holders received one share of Series B Convertible Preferred Stock for
each
$1,000 of principal and unpaid accrued interest on their notes. Thus, our
outstanding convertible notes were cancelled and converted into shares
of our
Series B Convertible Preferred Stock on March 14, 2008. Pursuant to the
terms of
the conversion, any unpaid accrued interest was added to the principal
of the
outstanding note and the sum was used to determine the number of shares
of
Series B Convertible Preferred Stock to be issued to the former note holder.
For
instance, if an investor held a senior convertible promissory note in the
amount
of $10,000 and such note had unpaid accrued interest of $570, the principal
and
interest were aggregated to equal $10,570 and the investor received 10.570
shares of Series B Convertible Preferred Stock. The table below lists each
former note holder’s name, the amount of principle of each former note holder’s
note as issued by us in June or July of 2007, and the amount of accrued
interest
as of the close of business on March 13, 2008, the day before the unpaid
accrued
interest of the note was converted into Series B Preferred Stock.
Investors
Holding Promissory Notes on March 13, 2008, Accrued Interest, and Shares
of
Series B Convertible Preferred Stock Received Upon Note
Conversion
Investor
Name
|
|
Amount of
Convertible Promissory Note
|
|
Accrued Interest
Through March
13, 2008
|
|
Shares of Series
B Convertible Preferred
Stock Received Upon
Note Conversion
|
|
Neel
B. Ackerman and Martha N. Ackerman
|
|
$
|
200,000.00
|
|
$
|
11,396
|
|
|
211.396
|
|
Vincent
M. Aita
|
|
$
|
10,000.00
|
|
$
|
570
|
|
|
10.570
|
|
Jesus
A. Anaya
|
|
$
|
25,000.00
|
|
$
|
1,402
|
|
|
26.402
|
|
Lucille
S. Ball Irrevocable Trust, Richard L. Clarkson, Trustee
|
|
$
|
85,000.00
|
|
$
|
4,766
|
|
|
89.766
|
|
Lee
P. Bearsch
|
|
$
|
50,000.00
|
|
$
|
2,803
|
|
|
52.803
|
|
David
Benadum
|
|
$
|
20,000.00
|
|
$
|
1,140
|
|
|
21.140
|
|
Frank
Calcutta
|
|
$
|
150,000.00
|
|
$
|
8,547
|
|
|
158.547
|
|
Duane
Clarkson
|
|
$
|
65,000.00
|
|
$
|
3,644
|
|
|
68.644
|
|
Clarkson
Trust, Richard L. Clarkson, Trustee
|
|
$
|
50,000.00
|
|
$
|
2,803
|
|
|
52.803
|
|
Cranshire
Capital, LP
|
|
$
|
250,000.00
|
|
$
|
14,017
|
|
|
264.017
|
|
CSA
Biotechnology Fund I, LLC
|
|
$
|
1,250,000.00
|
|
$
|
71,228
|
|
|
821.228
|
(1)
|
Michael
Cushing
|
|
$
|
50,000.00
|
|
$
|
2,803
|
|
|
52.803
|
|
Ennino
DePianto
|
|
$
|
25,000.00
|
|
$
|
1,402
|
|
|
26.402
|
|
Praful
Desai
|
|
$
|
75,000.00
|
|
$
|
4,273
|
|
|
79.273
|
|
Gregg
Dovolis
|
|
$
|
75,000.00
|
|
$
|
4,273
|
|
|
79.273
|
|
John
O. Dunkin
|
|
$
|
50,000.00
|
|
$
|
2,849
|
|
|
52.849
|
|
Franz
Family Trust, David and Nicole Franz, Trustees
|
|
$
|
25,000.00
|
|
$
|
1,424
|
|
|
26.424
|
|
Stephen
Gerber
|
|
$
|
100,000.00
|
|
$
|
5,698
|
|
|
105.698
|
|
Daniel
E. Greenleaf
|
|
$
|
17,500.00
|
|
$
|
997
|
|
|
18.497
|
|
Robert
Guercio
|
|
$
|
75,000.00
|
|
$
|
4,273
|
|
|
79.273
|
|
Robert
Joseph
|
|
$
|
25,000.00
|
|
$
|
1,402
|
|
|
26.402
|
|
Ronald
P. Laurain
|
|
$
|
25,000.00
|
|
$
|
1,424
|
|
|
26.424
|
|
Stephen
H. Lebovitz
|
|
$
|
25,000.00
|
|
$
|
1,424
|
|
|
26.424
|
|
Brian
Lenz
|
|
$
|
5,000.00
|
|
$
|
285
|
|
|
.285
|
(2)
|
S.
Alan Lisenby
|
|
$
|
150,000.00
|
|
$
|
8,547
|
|
|
158.547
|
|
Joe
Nitti
|
|
$
|
10,000.00
|
|
$
|
561
|
|
|
10.561
|
|
Thomas
& Denise M. Nudo
|
|
$
|
225,000.00
|
|
$
|
12,820
|
|
|
237.820
|
|
Alan
Platner
|
|
$
|
25,000.00
|
|
$
|
1,402
|
|
|
26.402
|
|
David
Pudelsky & Nancy Pudelsky
|
|
$
|
30,000.00
|
|
$
|
1,709
|
|
|
31.709
|
|
Louis
R. Reif
|
|
$
|
80,000.00
|
|
$
|
4,558
|
|
|
84.558
|
|
Suzanne
Schiller
|
|
$
|
25,000.00
|
|
$
|
1,424
|
|
|
26.424
|
|
George
L. Seward
|
|
$
|
25,000.00
|
|
$
|
1,402
|
|
|
26.402
|
|
Jerome
Shinkay
|
|
$
|
25,000.00
|
|
$
|
1,424
|
|
|
26.424
|
|
William
Silver
|
|
$
|
25,000.00
|
|
$
|
1,424
|
|
|
26.424
|
|
Vernon
L. Simpson
|
|
$
|
25,000.00
|
|
$
|
1,402
|
|
|
26.402
|
|
Lucile
Slocum
|
|
$
|
80,000.00
|
|
$
|
4,558
|
|
|
84.558
|
|
Pershing
LLC as Custodian for Howard M. Tanning
|
|
$
|
125,000.00
|
|
$
|
7,122
|
|
|
132.122
|
|
Carolyn
Taylor
|
|
$
|
100,000.00
|
|
$
|
5,698
|
|
|
105.698
|
|
Michael
Weiser
|
|
$
|
10,000.00
|
|
$
|
570
|
|
|
10.570
|
|
M.H.
Yokoyama & J.S. Venuti Family Trust dated 4/95
|
|
$
|
12,500.00
|
|
$
|
701
|
|
|
13.201
|
|
(1)
|
CSA
Biotechnology Fund I, LLC, invested $500,000 in our private
placement of
the Series A Convertible Preferred Stock and, pursuant to the
terms of the
Series B Convertible Preferred Stock, converted an amount equal
to such
investment on a dollar-for-dollar basis from Series B Convertible
Preferred Stock into Series A Preferred Stock. Thus, CSA Biotechnology
Fund’s number of shares of Series B Convertible Preferred Stock
was
reduced by the amount converted into Series A Convertible Preferred
Stock.
|
(2)
|
Brian
Lenz, our Former Chief Financial Officer, invested $5,000 in
our private
placement of Series A Convertible Preferred Stock and, pursuant
to the
terms of the Series B Convertible Preferred Stock, converted
an amount
equal to such investment on a dollar-for-dollar basis from
Series B
Convertible Preferred Stock into Series A Preferred Stock.
Thus, Mr.
Lenz’s number of shares of Series B Convertible Preferred Stock
was
reduced by the amount converted into Series A Convertible Preferred
Stock.
|
Conversion
of Notes Held by Officers and Directors
Brian
Lenz, our Former Chief Financial Officer, and Michael Weiser, one of our
directors, both invested in our offering of senior convertible promissory
notes
in June and July 2007. Mr. Lenz was issued a senior convertible promissory
note
in the amount of $5,000. Upon the conversion of Mr. Lenz’s note into shares of
our Series B Convertible Preferred Stock on March 14, 2008, the note had
accrued
$285 in interest. Mr. Lenz purchased 5 shares of our Series A Convertible
Preferred Stock on April 9, 2008. Pursuant to the terms of the Series B
Convertible Preferred Stock, as set forth in our Certificate of Designation
filed with the Delaware Secretary of State (filed as Exhibit 3.1 to the
Company's Form 8-K filed on March 20, 2008), Mr. Lenz converted an equal
amount
of his Series B Convertible Preferred Stock into shares of Series A Convertible
Preferred Stock on a dollar-for-dollar basis. Thus, Mr. Lenz currently
holds 10
shares of our Series A Convertible Preferred Stock and 0.285 shares of
our
series B Convertible Preferred Stock. Mr. Weiser was issued a senior
convertible promissory note in the amount of $10,000. Upon the conversion
of Mr.
Weiser’s note into shares of the Company’s Series B Convertible Preferred Stock
on March 14, 2008, the note had accrued $570 in interest. Mr. Weiser currently
hold 10.57 shares of our Series B Convertible Preferred
Stock.
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.
Following
the completion of our private placement of our Series A Convertible Preferred
Stock, we believe that our current capital will be adequate to fund our
operations through the third 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 most likely
require additional financing by as early as the third quarter of 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, or by potentially sublicensing our rights to our
products.
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.
Since
inception, the Company has incurred an accumulated deficit of $42,513,278
through March 31, 2008. For the three months ended March 31, 2008 and 2007,
the
Company had losses from continuing operations of $3,080,981 and $2,256,778,
respectively, and used $1,060,445 and $1,347,108 of cash in continuing operating
activities for the three months ended March 31, 2008 and 2007, respectively.
For
the three months ended March 31, 2008 and 2007, the Company had a net loss
of
$3,080,981 and a net loss of $2,518,253 (which included $2,256,778 from
continuing operations), respectively. As of March 31, 2008, the Company had
a
working capital deficit of $2,801,606 and cash and cash equivalents of $305,561.
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 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 11.6%
of
our outstanding common stock, and several trusts for the benefit of Dr.
Rosenwald and his family beneficially own 6.6% 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:
|
•
|
the
terms of our license agreements pursuant to which we obtain the right
to
develop and commercialize drug candidates, including the amount of
license
fees and milestone payments required under such
agreements;
|
|
•
|
the
results of any clinical trials;
|
|
•
|
the
scope and results of our research and development
programs;
|
|
•
|
the
time required to obtain regulatory
approvals;
|
|
•
|
our
ability to establish and maintain marketing alliances and collaborative
agreements; and
|
|
•
|
the
cost of our internal marketing
activities.
|
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:
|
•
|
acquire
the rights to develop and commercialize a drug
candidate;
|
|
•
|
undertake
pre-clinical development and clinical trials for drug candidates
that we
acquire;
|
|
•
|
seek
regulatory approvals for drug
candidates
|
|
•
|
implement
additional internal systems and
infrastructure;
|
|
•
|
lease
additional or alternative office facilities;
and
|
|
•
|
hire
additional personnel.
|
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:
|
•
|
delay
commercialization of, and our ability to derive product revenues
from, a
drug candidate;
|
|
•
|
impose
costly procedures on us; and
|
|
•
|
diminish
any competitive advantages that we may otherwise
enjoy.
|
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:
|
•
|
unforeseen
safety issues;
|
|
•
|
determination
of dosing issues;
|
|
•
|
lack
of effectiveness during clinical
trials;
|
|
•
|
slower
than expected rates of patient
recruitment;
|
|
•
|
inability
to monitor patients adequately during or after treatment;
and
|
|
•
|
inability
or unwillingness of medical investigators to follow our clinical
protocols.
|
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:
|
•
|
perceptions
by members of the health care community, including physicians, about
the
safety and effectiveness of our
drugs;
|
|
•
|
cost-effectiveness
of our product relative to competing
products;
|
|
•
|
availability
of reimbursement for our products from government or other healthcare
payers; and
|
|
•
|
effectiveness
of marketing and distribution efforts by us and our licensees and
distributors, if any.
|
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:
|
•
|
We
may be unable to identify manufacturers on commercially reasonable
terms
or at all because the number of potential manufacturers is limited
and the
FDA must approve any replacement contractor. This approval would
require
new testing and compliance inspections. In addition, a new manufacturer
would have to be educated in, or develop substantially equivalent
processes for, production of our products after receipt of FDA approval,
if any.
|
|
•
|
Our
third-party manufacturers might be unable to formulate and manufacture
our
drugs in the volume and of the quality required to meet our clinical
needs
and commercial needs, if any.
|
|
•
|
Our
future contract manufacturers may not perform as agreed or may not
remain
in the contract manufacturing business for the time required to supply
our
clinical trials or to successfully produce, store and distribute
our
products.
|
|
•
|
Drug
manufacturers are subject to ongoing periodic unannounced inspection
by
the FDA, the DEA, and corresponding state agencies to ensure strict
compliance with good manufacturing practice and other government
regulations and corresponding foreign standards. We do not have control
over third-party manufacturers’ compliance with these regulations and
standards.
|
|
•
|
If
any third-party manufacturer makes improvements in the manufacturing
process for our products, we may not own, or may have to share, the
intellectual property rights to the
innovation.
|
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:
|
•
|
undertaking
pre-clinical testing and human clinical
trials;
|
|
•
|
obtaining
FDA and other regulatory approvals of
drugs;
|
|
•
|
formulating
and manufacturing drugs; and
|
|
•
|
launching,
marketing and selling drugs.
|
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:
|
•
|
announcements
of technological innovations or new commercial products by our competitors
or us;
|
|
•
|
developments
concerning proprietary rights, including
patents;
|
|
•
|
regulatory
developments in the United States and foreign
countries;
|
|
•
|
economic
or other crises and other external
factors;
|
|
•
|
period-to-period
fluctuations in our revenues and other results of
operations;
|
|
•
|
changes
in financial estimates by securities analysts;
and
|
|
•
|
sales
of our common stock.
|
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.
NOTE
REGARDING FORWARD-LOOKING STATEMENTS
Certain
statements contained in this prospectus that are forward-looking in nature
are
based on the current beliefs of our management as well as assumptions made
by
and information currently available to management, including statements related
to the markets for our products, general trends in our operations or financial
results, plans, expectations, estimates and beliefs. In addition, when used
in
this prospectus, the words “may,” “could,” “should,”
“anticipate,” “believe,” “estimate,” “expect,”
“intend,” “plan,” “predict” and similar expressions and their
variants, as they relate to us or our management, may identify forward-looking
statements. These statements reflect our judgment as of the date of this
prospectus with respect to future events, the outcome of which are subject
to
risks, which may have a significant impact on our business, operating results
or
financial condition. You are cautioned that these forward-looking statements
are
inherently uncertain. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual results
or
outcomes may vary materially from those described herein. We undertake no
obligation to update forward-looking statements. The risks identified under
the
heading “Risk Factors” in this prospectus, among others, may impact
forward-looking statements contained in this prospectus.
USE
OF PROCEEDS
We
will
not receive any proceeds from the resale of any of the shares offered by this
prospectus by the selling stockholders.
SELLING
STOCKHOLDERS
The
following table sets forth the number of shares of the common stock owned
by the
selling stockholders as of July 31, 2008, and after giving effect to this
offering. The percentage indicated for each selling stockholder in the column
entitled “percentage beneficial ownership after the offering” assumes the sale
of all the shares offered by this prospectus.
Shares
Issued Pursuant to Private Placement of Series A Convertible Preferred
Stock
|
|
|
|
Number
of Shares of Common
Stock
Issuable Upon
:
|
|
Of the Shares Issuable the
Following Shares are Registered
in This Prospectus:
|
|
|
|
Selling Stockholder
|
|
Shares
Beneficially
Owned
Before
Offering
|
|
Conversion of
Series A
Convertible
Preferred Stock
|
|
Exercise of
Warrants +
|
|
Shares Issuable
Upon
Conversion of
Series A
Convertible
Preferred Stock
|
|
Shares
Issuable Upon Exercise of
Warrants +
|
|
Percentage
Beneficial
Ownership
After Offering
|
|
AB Capital,
L.P.
(a)
|
|
|
150,000
|
|
|
100,000
|
|
|
50,000
|
|
|
14,285
|
|
|
7,142
|
|
|
-
|
|
Adams
Market Neutral, LLLP
(b)
|
|
|
75,000
|
|
|
50,000
|
|
|
25,000
|
|
|
7,142
|
|
|
3,571
|
|
|
-
|
|
Fernando
Ahumada
|
|
|
107,466
|
(1)
|
|
66,667
|
|
|
33,333
|
|
|
9,563
|
|
|
4,762
|
|
|
*
|
|
Jorge
Ahumada
|
|
|
59,332
|
(2)
|
|
33,333
|
|
|
16,667
|
|
|
4,762
|
|
|
2,381
|
|
|
*
|
|
Balanced
Investment, LLC
(c)
|
|
|
220,833
|
|
|
125,000
|
|
|
62,500
|
|
|
17,856
|
|
|
8,928
|
|
|
*
|
|
Alp
Benadrete
|
|
|
56,250
|
|
|
37,500
|
|
|
18,750
|
|
|
5,375
|
|
|
2,687
|
|
|
-
|
|
Izzet
Benadrete
|
|
|
125,000
|
|
|
83,333
|
|
|
41,667
|
|
|
11,904
|
|
|
5,952
|
|
|
-
|
|
Capretti
Grandi, LLC
(d)
|
|
|
1,375,000
|
(3)
|
|
833,333
|
|
|
416,667
|
|
|
119,040
|
|
|
59,520
|
|
|
-
|
|
Tim
P. Cooper
|
|
|
50,000
|
|
|
33,333
|
|
|
16,667
|
|
|
4,762
|
|
|
2,381
|
|
|
-
|
|
Russell
H. Ellison
|
|
|
25,000
|
|
|
16,667
|
|
|
8,333
|
|
|
2,381
|
|
|
1,190
|
|
|
-
|
|
Rifat
Eskenazi
|
|
|
170,000
|
|
|
113,333
|
|
|
56,667
|
|
|
16,189
|
|
|
8,095
|
|
|
-
|
|
Steven
T. Glass
|
|
|
62,500
|
|
|
41,667
|
|
|
20,833
|
|
|
5,952
|
|
|
2,976
|
|
|
-
|
|
Ben
Heller
|
|
|
200,000
|
|
|
133,333
|
|
|
66,667
|
|
|
19,046
|
|
|
9,523
|
|
|
-
|
|
Elliot
H. Herskowitz IRA Rollover
|
|
|
154,156
|
(4)
|
|
83,333
|
|
|
41,667
|
|
|
11,904
|
|
|
5,952
|
|
|
*
|
|
Neil
Herskowitz IRA Rollover
|
|
|
162,434
|
(5)
|
|
83,333
|
|
|
41,667
|
|
|
11,904
|
|
|
5,952
|
|
|
*
|
|
High
Glen Properties Limited
(e)
|
|
|
250,000
|
|
|
166,667
|
|
|
83,333
|
|
|
23,808
|
|
|
11,904
|
|
|
-
|
|
David
Jaroslawicz
|
|
|
208,000
|
(6)
|
|
133,333
|
|
|
66,667
|
|
|
19,046
|
|
|
9,523
|
|
|
*
|
|
Daniel
U. Kelves & BettyAnn Kelves
|
|
|
15,833
|
|
|
8,333
|
|
|
4,167
|
|
|
1,190
|
|
|
595
|
|
|
*
|
|
Charles
Hartman King
|
|
|
62,500
|
|
|
41,667
|
|
|
20,833
|
|
|
5,952
|
|
|
2,976
|
|
|
-
|
|
CSA
Biotechnology Fund II, LLC
(f)
|
|
|
1,965,014
|
(7)
|
|
1,666,667
|
|
|
833,333
|
|
|
238,080
|
|
|
119,040
|
|
|
*
|
|
Klaus
Kretschmer
|
|
|
500,000
|
|
|
333,334
|
|
|
166,667
|
|
|
47,616
|
|
|
23,808
|
|
|
-
|
|
Nicholas
B. Kronwall Trust Dated 11/12/69
|
|
|
42,133
|
|
|
16,667
|
|
|
8,333
|
|
|
2,381
|
|
|
1,910
|
|
|
*
|
|
Brian
Lenz
|
|
|
80,238
|
(8)
|
|
16,667
|
|
|
8,333
|
|
|
2,381
|
|
|
1,910
|
|
|
*
|
|
Javier
Livas
|
|
|
25,000
|
|
|
16,667
|
|
|
8,333
|
|
|
2,381
|
|
|
1,910
|
|
|
-
|
|
Harris
Lydon
|
|
|
292,270
|
(9)
|
|
16,667
|
|
|
8,333
|
|
|
2,381
|
|
|
1,910
|
|
|
*
|
|
Susan
and Harry Newton, JTWROS
|
|
|
125,000
|
|
|
83,333
|
|
|
41,667
|
|
|
11,904
|
|
|
5,952
|
|
|
-
|
|
Mario
Pasquel and Begona Miranda
|
|
|
32,388
|
(10)
|
|
16,667
|
|
|
8,333
|
|
|
2,381
|
|
|
1,910
|
|
|
*
|
|
Neal
Polan
|
|
|
62,500
|
|
|
41,667
|
|
|
20,833
|
|
|
5,952
|
|
|
2,976
|
|
|
-
|
|
Elke
R de Ramirez
|
|
|
28,312
|
(11)
|
|
16,667
|
|
|
8,333
|
|
|
2,381
|
|
|
1,910
|
|
|
*
|
|
Riverside
Contracting, LLC
(g)
|
|
|
402,156
|
(12)
|
|
250,000
|
|
|
125,000
|
|
|
35,712
|
|
|
17,856
|
|
|
*
|
|
Robert
Roth
|
|
|
25,000
|
|
|
16,667
|
|
|
8,333
|
|
|
2,381
|
|
|
1,910
|
|
|
-
|
|
Roberto
Segovia
|
|
|
27,004
|
|
|
15,000
|
|
|
7,500
|
|
|
2,143
|
|
|
1,071
|
|
|
*
|
|
South
Ferry #2 LP
(h)
|
|
|
1,316,666
|
|
|
833,333
|
|
|
416,667
|
|
|
119,040
|
|
|
59,520
|
|
|
*
|
|
Starlight
Investment Holdings Limited
(i)
|
|
|
250,000
|
|
|
166,667
|
|
|
83,333
|
|
|
23,808
|
|
|
11,904
|
|
|
*
|
|
Tokenhouse
Trading PTE Ltd.
(j)
|
|
|
183,915
|
(13)
|
|
83,333
|
|
|
41,667
|
|
|
11,904
|
|
|
5,952
|
|
|
*
|
|
Lindsay
A. Rosenwald
|
|
|
626,002
|
(14)
|
|
-
|
|
|
251,666
|
|
|
-
|
|
|
35,950
|
|
|
4.0
|
|
Karl
Ruggeberg
|
|
|
40,667
|
|
|
-
|
|
|
40,667
|
|
|
-
|
|
|
5,809
|
|
|
-
|
|
Julstin
Welling
|
|
|
1,667
|
|
|
-
|
|
|
1,667
|
|
|
-
|
|
|
238
|
|
|
-
|
|
Ece
Marcelli
|
|
|
23,416
|
|
|
-
|
|
|
23,416
|
|
|
-
|
|
|
3,345
|
|
|
-
|
|
+
Warrants listed here are excluded from mention in the footnotes
below.
*
Less
than 1%.
(1)
Includes warrant to purchase 2,133 shares.
(2)
Includes warrant to purchase 2,666 shares.
(3)
Dr.
Lindsay Rosenwald is a controlling executive of Capretti Grandi,
LLC. Based on a
Schedule 13G/A filed on December 31, 2007, and Dr. Rosenwald may
also be deemed
to beneficially own the following securities (which are not included
in the
table above for Capretti): (i) 128,548 shares issuable upon the exercise
of
warrants; and (ii) 39,283 shares held by Paramount BioCapital Investments,
LLC
of which Dr. Rosenwald is the managing member.
(4)
Includes: (i) 2,000 shares owned by Mr. Herskowitz; and (ii) 27,156
shares owned
by Riverside Contracting, LLC, of which Mr. Heskowitz is a
co-owner.
(5)
Includes: (i) 10,278 shares owned by Mr. Herskowitz; and (ii) 27,156
shares
owned by Riverside Contracting, LLC, of which Mr. Herskowitz is a
co-owner and
has dispositive control of such shares.
(6)
Includes warrant to purchase 8,000 shares.
(7)
Includes warrant to purchase 416,667 shares. Stockholder also owns
821,228
shares of the Series B Convertible Preferred Stock, which is convertable
into
216,112 shares of common stock and holds a warrant to purchase 82,236
shares.
(8)
In
addition to the shares being registered, represents: (i) shares issuable
upon
exercise (at a price of $0.54 per share) of an option to purchase
1,500 shares;
(ii) shares issuable upon exercise (at a price of $0.54 per share)
of an option
to purchase 2,500 shares; (iii) shares issuable upon exercise (at
a price of
$0.54 per share) of an option, 6,000 shares of which were vested
as of January
24, 2008; (iv) shares issuable upon exercise (at a price of $0.54
per share) of
an option 6,667 shares of which vested as of November 29, 2007; (v)
shares
issuable upon exercise (at a price of $0.54 per share) of an option,
of which
6,667 shares were vested as of March 31, 2008; (vi) shares issuable
upon
exercise (at a price of $0.54 per share) of an option, of which 3,334
shares
were vested on May 11, 2008; (vii) 1,500 shares of common stock;
and (viii)
shares issuable upon exercise (at a price of $0.54 per share) of
an option,
26,667 of which were vested as of June 13, 2008. Stockholder also
owns .285
shares of series B Convertable Preferred Stock, which is convertible
into 75
shares of common stock, and holds a warrant to purchase 328 shares.
Mr. Lenz is
our Former Chief Financial Officer.
(9)
Includes warrants to purchase 39,285 shares.
(10)
Includes warrants to purchase 2,240 shares.
(11)
Includes warrants to purchase 1,015 shares.
(12)
Includes 27,156 shares owned by Stockholder. It does not include:
(i) 2,000
shares owned by Elliot Herskowitz, co-owner of Stockholder; or (ii)
10,278
shares owned by Neil Herskowitz, a co-owner of Stockholder.
(13)
Includes warrants to purchase 17,249 shares.
(14)
In
addition to the shares being registered, represents: (i) 204,400
shares owned by
stockholder; (ii) 128,548 shares issuable upon exercise of warrants;
and (iii)
39,283 shares held by Paramount BioSciences, LLC, of which stockholder
is the
sole member. It does not include shares held by Capretti Grandi as
otherwise
disclosed in this table.
(a)
Trygue Mikkelsen, Managing Partner of AB Capital, LP, has voting
and/or
dispositive control over the shares held by such selling
shareholder.
(b)
Patrick Adams, Managing Partner of Adams Market Neutral, LLLP,
has voting and/or
dispositive control over the shares held by such selling
shareholder.
(c)
Alonso Diaz, the Investment Adviser of Balanced Investment, LLC,
has voting
and/or dispositive control over the shares held by such selling
shareholder.
(d)
Lindsay A. Rosenwald, the Member Manager of Capretti Grandi, LLC,
has voting
and/or dispositive control over the shares held by such selling
shareholder.
(e)
David
Ulmer, Vice President of High Glen Properties Limited, has voting
and/or
dispositive control over the shares held by such selling
shareholder.
(f)
Madding King, the Managing Member of CSA Biotechnology Fund II,
LLC, has voting
and/or dispositive control over the shares held by such selling
shareholder.
(g)
Neil
Herskowitz, the Managing Member of Riverside Contracting, LLC,
has voting and/or
dispositive control over the shares held by such selling
stockholder
(h)
Morris Wolfson, Portfolio Manager at South Ferry #2, LP, has voting
and/or
dispositive control over the shares held by such selling
stockholder.
(i)
David
Jenner and Nicola Hodge, Directors of Starlight Investment Holding
Limited, have
voting and/or dispositive control over the shares held by such
selling
shareholder.
(j)
The
following persons share voting and investment control over the
shares held by
such selling stockholder: Angela Alabons, Rocio Benalcazar, Sonja
Beskid,
Monique Bhullar, Veronica Boss, Jonathan Boroski, Kay Bower, Ingrid
Boyd,
Isabelle Cadosch, Anne Davidsson, Angela Delgado, Daniel Des Roches,
Juliet Diaz
Wiederkehr, Gordana Djurin, Yuko Eggmann-Murakami, Gordana Elliott,
Jeremias
Fernandes, Raelene Gabrielli, Helen Godwin, Christine Green, Shakera
Johnson,
Tanya Knowles, Cristina Lepori, Laura Lees, Terence Loh, Tim Parkinson,
Gayathri
Perera, Cecile Pernet, Marek Ponte, Rita Serena, Lisa Siu, Nina
Stanic, Kenton
Strachan, Monica Stricker, Rave Thlagarajan, Evelyn Tay, Laura
Thompson, Oksana
Thorn, Noel Took, Stephen Upton, Oilvija Vencov, Daved Van Heerden,
Narae Walks,
Steven Weekes, Maria Weigel, Adzam Yosuf, or Jasmina
Zivkovic.
PRIOR
TRANSACTIONS BETWEEN ISSUER AND THE SELLING SHAREHOLDERS
In
our
previous financing transactions, we have sold securities to several of the
selling shareholders listed in the table above. The following table sets
forth
the selling shareholders from our recent private placement of preferred stock
and any prior transactions with the selling shareholders participating in
our
recent private placement of preferred stock. Please note that all share amounts
and stock prices reflect post-split numbers. Please also note that the "Number
of Shares Issuable upon Conversion of Series A" and the "Number of Shares
Issuable upon Exercise of Warrants" includes all of the shares issuable which
is
greater than the number of shares registered for resale in this
prospectus. On April 8, 2008, the market price of our common stock was $0.80.
On
August 1, 2008, the market price at closing was $0.65.
Selling
Shareholders Owning Series A Convertible Preferred
Stock
CURRENT
TRANSACTION
|
|
|
PRIOR
TRANSACTIONS
|
|
Name
|
|
|
Shares
Beneficially Owned Before Offering
|
|
|
No.
of Shares Issuable upon conversion of Series A
|
|
|
No.
of Shares Issuable upon Exercise of Warrants
|
|
|
Transaction
|
|
|
Shares
Beneficially Owned Before Offering
|
|
|
Common
Stock
|
|
|
No.
of Shares Issuable upon Exercise of Warrants
|
|
|
Transaction
|
|
|
Shares
Beneficially Owned Before Offering
|
|
|
Common
Stock
|
|
|
No.
of Shares Issuable upon Exercise of Warrants
|
|
AB
Capital, L.P.
|
|
|
150,000
|
|
|
100,000
|
|
|
50,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adams
Market Neutral, LLLP
|
|
|
75,000
|
|
|
50,000
|
|
|
25,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fernando
Ahumada
|
|
|
107,466
|
|
|
66,667
|
|
|
33,333
|
|
|
A
|
|
|
7,466
|
|
|
5,333
|
|
|
2,133
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jorge
Ahumada
|
|
|
59,332
|
|
|
33,333
|
|
|
16,667
|
|
|
A
|
|
|
9,333
|
|
|
6,666
|
|
|
2,666
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balanced
Investment
|
|
|
220,833
|
|
|
125,000
|
|
|
62,500
|
|
|
A
|
|
|
48,666
|
|
|
13,333
|
|
|
5,333
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alp
Benadrete
|
|
|
56,250
|
|
|
37,500
|
|
|
18,750
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Izzet
Benadrete
|
|
|
125,000
|
|
|
83,333
|
|
|
41,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capretti
Grandi, LLC
|
|
|
1,375,000
|
|
|
833,333
|
|
|
416,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tim
P. Cooper
|
|
|
50,000
|
|
|
33,333
|
|
|
16,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Russell
H. Ellison
|
|
|
25,000
|
|
|
16,667
|
|
|
8,333
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rifat
Eskenazi
|
|
|
170,000
|
|
|
113,333
|
|
|
56,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven
T. Glass
|
|
|
62,500
|
|
|
41,667
|
|
|
20,833
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ben
Heller
|
|
|
200,000
|
|
|
133,333
|
|
|
66,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Elliot
H. Herskowitz IRA Rollover
|
|
|
154,156
|
|
|
83,333
|
|
|
41,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neil
Herskowitz IRA Rollover
|
|
|
162,434
|
|
|
83,333
|
|
|
41,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
High
Glen Properties Limited
|
|
|
250,000
|
|
|
166,667
|
|
|
83,333
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
David
Jaroslawicz
|
|
|
200,000
|
|
|
133,333
|
|
|
66,667
|
|
|
A
|
|
|
8,000
|
|
|
-
|
|
|
8,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Daniel
U. Kelves & BettyAnn Kelves
|
|
|
15,833
|
|
|
8,333
|
|
|
4,167
|
|
|
A
|
|
|
4,666
|
|
|
3,333
|
|
|
1,333
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charles
Hartman King
|
|
|
62,500
|
|
|
41,667
|
|
|
20,833
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CSA
Biotechnology Fund II
|
|
|
2,916,667
|
|
|
1,666,667
|
|
|
833,333
|
|
|
D
|
|
|
715,015
|
|
|
216,112
|
|
|
82,236
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Klaus
Kretschmer
|
|
|
500,000
|
|
|
333,333
|
|
|
166,667
|
|
|
C
|
|
|
54,000
|
|
|
40,000
|
|
|
14,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nicholas
B. Kronwall Trust Dated 11/12/69
|
|
|
25,000
|
|
|
16,667
|
|
|
8,333
|
|
|
A
|
|
|
11,416
|
|
|
3,333
|
|
|
1,333
|
|
|
C
|
|
|
11,516
|
|
|
5,000
|
|
|
1,750
|
|
Brian
Lenz
|
|
|
80,238
|
|
|
16,667
|
|
|
8,333
|
|
|
D
|
|
|
55,238
|
|
|
75
|
|
|
328
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Javier
Livas
|
|
|
25,000
|
|
|
16,667
|
|
|
8,333
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Harris
Lydon
|
|
|
292,270
|
|
|
16,667
|
|
|
183,333
|
|
|
A
|
|
|
7,407
|
|
|
-
|
|
|
4,766
|
|
|
D
|
|
|
92,270
|
|
|
-
|
|
|
32,895
|
|
Susan
and Harry Newton, JTWROS
|
|
|
125,000
|
|
|
83,333
|
|
|
41,667
|
|
|
A
|
|
|
41,500
|
|
|
2,000
|
|
|
8,000
|
|
|
C
|
|
|
41,500
|
|
|
2,000
|
|
|
8,000
|
|
Mario
Pasquel and Begona Miranda
|
|
|
32,388
|
|
|
16,667
|
|
|
8,333
|
|
|
A
|
|
|
6,481
|
|
|
3,333
|
|
|
1,333
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neal
Polan
|
|
|
62,500
|
|
|
41,667
|
|
|
20,833
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Elke
R de Ramirez
|
|
|
28,312
|
|
|
16,667
|
|
|
8,333
|
|
|
A
|
|
|
3,313
|
|
|
1,333
|
|
|
5,333
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Riverside
Contracting, LLC
|
|
|
402,156
|
|
|
250,000
|
|
|
125,000
|
|
|
A
|
|
|
40,922
|
|
|
6,666
|
|
|
2,626
|
|
|
C
|
|
|
40,922
|
|
|
20,000
|
|
|
7,000
|
|
Robert
Roth
|
|
|
25,000
|
|
|
16,667
|
|
|
8,333
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Roberto
Segovia
|
|
|
27,004
|
|
|
15,000
|
|
|
7,500
|
|
|
A
|
|
|
6,490
|
|
|
2,666
|
|
|
1,066
|
|
|
|
|
|
|
|
|
|
|
|
|
|
South
Ferry #2 LP
|
|
|
1,316,666
|
|
|
833,333
|
|
|
416,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Starlight
Investment Holdings Limited
|
|
|
250,000
|
|
|
166,667
|
|
|
83,333
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tokenhouse
Trading PTE Ltd.
|
|
|
183,915
|
|
|
83,333
|
|
|
41,667
|
|
|
A
|
|
|
58,916
|
|
|
13,333
|
|
|
5,333
|
|
|
C
|
|
|
58,916
|
|
|
15,000
|
|
|
5,250
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lindsay
A. Rosenwald
|
|
|
636,002
|
|
|
-
|
|
|
251,666
|
|
|
A
|
|
|
342,599
|
|
|
-
|
|
|
61,629
|
|
|
C
|
|
|
347,099
|
|
|
-
|
|
|
4,500
|
|
Lindsay
A. Rosenwald
|
|
|
|
|
|
|
|
|
|
|
|
B
|
|
|
342,599
|
|
|
115,619
|
|
|
27,000
|
|
|
D
|
|
|
384,336
|
|
|
-
|
|
|
12,105
|
|
Karl
Ruggeberg
|
|
|
40,667
|
|
|
-
|
|
|
40,667
|
|
|
A
|
|
|
5,924
|
|
|
-
|
|
|
3,283
|
|
|
C
|
|
|
4,942
|
|
|
-
|
|
|
4,942
|
|
Karl
Ruggeberg
|
|
|
|
|
|
|
|
|
|
|
|
B
|
|
|
5,924
|
|
|
2,141
|
|
|
500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Justin
Welling
|
|
|
1,667
|
|
|
-
|
|
|
1,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ece
Marcelli
|
|
|
23,416
|
|
|
-
|
|
|
23,416
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PRIOR
TRANSACTIONS WITH AFFILIATED PARTIES
CURRENT
TRANSACTION
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PRIOR
TRANSACTIONS
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Name
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Shares
Beneficially Owned Before Offering
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No.
of Shares Issuable upon conversion of Series A
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No.
of Shares Issuable upon Exercise of Warrants
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Transaction
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Shares
Beneficially Owned Before Offering
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Common
Stock
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No.
of Shares Issuable upon Exercise of Warrants
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Transaction
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Shares
Beneficially Owned Before Offering
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Common
Stock
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No.
of Shares Issuable upon Exercise of Warrants
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Michael
D. Becker
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5,000
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-
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-
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Stephen
C. Rocamboli
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95,840
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-
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-
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B
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86,333
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61,663
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14,400
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Edward
C. Bradley, M.D.
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47,667
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-
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-
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Johnson
Y.N. Lau, M.D., Ph.D.
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33,000
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-
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-
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Paramount
BioCapital Investments LLC
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B
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39,283
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39,283
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-
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Lester
Lipschutz
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1,054,136
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-
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-
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B
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1,054,136
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699,283
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163,300
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Michael
Weiser
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200,601
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-
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-
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B
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189,206
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119,901
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28,000
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D
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200,601
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2,781
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657
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Transaction
Notes
A
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October
2005 Private Placement
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4,672,951 shares were outstanding prior to this transaction; 2,541,106 of
which
were held by non-affiliates.
1,117,997
shares of common stock and 558,997 shares issuable upon exercise of warrants
(exercisable at $10.00) were issued in this offering.
Shares
issued were approximately 39.6% of the number of shares held by non-affiliates.
The market (closing) price of the common stock was
$8.50
immediately prior to this offering. The purchase price for the shares in
the
offering was $7.50.
B
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Shares
issued to former stockholders of Greenwich Therapeutics, Inc.
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4,672,951 shares were outstanding prior to this transaction;
2,541,106
of which were held by non-affiliates. 1,712,879 shares of common stock and
400,000 shares issuable upon exercise of warrants
(exercisable
at $14.10) were issued in this offering. Shares issued were approximately
67.4%
of the number of shares held by non-affiliates.
The
market (closing) price of the common stock was $8.50 immediately prior to
this
offering. The purchase price for the shares in the offering
was
valued at $7.00 per share.
C
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October
2006 Private Placement
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5,462,111 shares were outstanding prior to this transaction; 3,176,236 of
which
were held by non-affiliates.
789,160
shares of common stock and 315,664 shares issuable upon exercise of warrants
(exercisable at $7.30) were issued
in
this
offering. Shares issued were approximately 24.8% of the number of shares
held by
non-affiliates. The market (closing) price
of
the
common stock was $5.80 immediately prior to this offering. The purchase price
for the shares in the offering was $5.00.
D
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Issuance
of Series B Convertible Preferred Stock in March 2008
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5,461,644 shares were outstanding prior to this transaction, 3,882,202
of which
were held by non-affiliates. 896,096 shares of common stock, underlying
3,405.165 shares of Series B Convertible Preferred Stock, are issuable
upon
conversion of the Series B Convertible Preferred Stock at a price of $3.80
per
share of common stock. 243,397 shares of common stock are issuable at a
price of
$4.00 per share upon exercise of warrants issued to the holders of the
Series B
Convertible Preferred Stock at the time of their purchase of the
formerly-outstanding senior convertible promissory notes in June and July
2007.
The market (closing) price of the common stock was $3.80 at the time of
the sale
of the convertible promissory notes in June and July 2007 and $1.20 immediately
prior to the conversion of the convertible promissory notes on March 14,
2008.
Comparison
of Registered Shares to Outstanding Shares
The
following table sets forth: (i) the number of shares of our common stock held
by
persons other than the selling shareholders listed above, their affiliates,
or
our affiliates; (ii) the number of shares of our common stock registered for
resale by the selling shareholders in prior prospectuses; (iii) the number
of
shares of our common stock registered for resale by the selling shareholders
in
prior prospectuses that continue to be held by the selling shareholders; (iv)
the number of shares of our common stock registered for resale by the selling
shareholders that have been sold in resale transactions; and (v) the number
of
shares of our common stock registered for resale on behalf of the selling
shareholders in this prospectus. Please note that except for the column titled
“Shares of Common Stock Registered for Resale on Behalf of Selling Shareholders
in This Prospectus,” the table below does not reflect any shares of our common
stock underlying any convertible securities, options or warrants. We included
the shares underlying our Series A and Series B Convertible Preferred Stock
in
the “Shares of Common Stock Registered for Resale on Behalf of Selling
Shareholders in This Registration Statement” column because all of the shares
registered for resale in this prospectus are issuable upon conversion of our
preferred stock. The table was prepared based on the most recent representations
of the shareholders.
Shares
of Common Stock Held by Persons Other Than Selling
Shareholders
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Shares
of Common Stock Registered for Resale by Selling Shareholders in
Prior
Prospectuses
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Shares
of Common Stock Registered for Resale by Selling Shareholders in
Prior
Prospectuses that Continue to be Held by Selling
Shareholders
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Shares
of Common Stock Registered for Resale by Selling Shareholders in
Prior
Prospectuses that Have been Sold in Resale Transactions
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Shares
of Common Stock Registered for Resale on Behalf of the Selling
Shareholders in this Prospectus
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3,882,202
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482,387
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339,058
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143,239
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1,307,581
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PLAN
OF DISTRIBUTION
We
are
registering the shares offered by this prospectus on behalf of the selling
stockholders. The selling stockholders, which as used herein includes donees,
pledgees, transferees or other successors-in-interest selling shares of common
stock or interests in shares of common stock received after the date of this
prospectus from a selling stockholder as a gift, pledge, partnership
distribution or other transfer, may, from time to time, sell, transfer or
otherwise dispose of any or all of their shares of common stock or interests
in
shares of common stock on any stock exchange, market or trading facility on
which the shares are traded or in private transactions. These dispositions
may
be at fixed prices, at prevailing market prices at the time of sale, at prices
related to the prevailing market price, at varying prices determined at the
time
of sale, or at negotiated prices. To the extent any of the selling stockholders
gift, pledge or otherwise transfer the shares offered hereby, such transferees
may offer and sell the shares from time to time under this prospectus, provided
that this prospectus has been amended under Rule 424(b)(3) or other applicable
provision of the Securities Act to include the name of such transferee in the
list of selling stockholders under this prospectus.
The
selling stockholders may use any one or more of the following methods when
disposing of shares or interests therein:
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ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
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block
trades in which the broker-dealer will attempt to sell the shares
as
agent, but may position and resell a portion of the block as principal
to
facilitate the transaction;
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purchases
by a broker-dealer as principal and resale by the broker-dealer for
its
account;
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an
exchange distribution in accordance with the rules of the applicable
exchange;
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privately
negotiated transactions;
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short
sales;
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through
the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise;
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broker-dealers
may agree with the selling stockholders to sell a specified number
of such
shares at a stipulated price per share;
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a
combination of any such methods of sale; and
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any
other method permitted pursuant to applicable
law.
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The
selling stockholders may, from time to time, pledge or grant a security interest
in some or all of the shares of common stock owned by them and, if they default
in the performance of their secured obligations, the pledgees or secured parties
may offer and sell the shares of common stock, from time to time, under this
prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or
other applicable provision of the Securities Act amending the list of selling
stockholders to include the pledgee, transferee or other successors in interest
as selling stockholders under this prospectus.
In
connection with the sale of our common stock or interests therein, the selling
stockholders may enter into hedging transactions with broker-dealers or other
financial institutions, which may in turn engage in short sales of the common
stock in the course of hedging the positions they assume. The selling
stockholders may also sell shares of our common stock short and deliver these
securities to close out their short positions, or loan or pledge the common
stock to broker-dealers that in turn may sell these securities. The selling
stockholders may also enter into option or other transactions with
broker-dealers or other financial institutions or the creation of one or more
derivative securities which require the delivery to such broker-dealer or other
financial institution of shares offered by this prospectus, which shares such
broker-dealer or other financial institution may resell pursuant to this
prospectus (as supplemented or amended to reflect such
transaction).
The
aggregate proceeds to the selling stockholders from the sale of the common
stock
offered by them will be the purchase price of the common stock less discounts
or
commissions, if any. Each of the selling stockholders reserves the right to
accept and, together with their agents from time to time, to reject, in whole
or
in part, any proposed purchase of common stock to be made directly or through
agents. We will not receive any of the proceeds from this offering. Upon any
exercise of the warrants by payment of cash, however, we will receive the
exercise price of the warrants.
The
selling stockholders also may resell all or a portion of the shares in open
market transactions in reliance upon Rule 144 under the Securities Act of
1933,
provided that they meet the criteria and conform to the requirements of that
rule. The number of shares registered for resale in this prospectus has been
limited pursuant to Rule 415. We have only registered for resale a percentage
of
the shares of common stock underlying our Series A convertible preferred
stock and related warrants.
The
selling stockholders might be, and any broker-dealers that act in connection
with the sale of securities will be, deemed to be “underwriters” within the
meaning of Section 2(11) of the Securities Act, and any commissions received
by
such broker-dealers and any profit on the resale of the securities sold by
them
while acting as principals will be deemed to be underwriting discounts or
commissions under the Securities Act.
To
the
extent required, the shares of our common stock to be sold, the names of the
selling stockholders, the respective purchase prices and public offering prices,
the names of any agents, dealer or underwriter, any applicable commissions
or
discounts with respect to a particular offer will be set forth in an
accompanying prospectus supplement or, if appropriate, a post-effective
amendment to the registration statement that includes this
prospectus.
In
order
to comply with the securities laws of some states, if applicable, the common
stock may be sold in these jurisdictions only through registered or licensed
brokers or dealers. In addition, in some states the common stock may not be
sold
unless it has been registered or qualified for sale or an exemption from
registration or qualification requirements is available and is complied
with.
We
have
advised the selling stockholders that the anti-manipulation rules of Regulation
M under the Exchange Act may apply to sales of shares in the market and to
the
activities of the selling stockholders and their affiliates. In addition, we
will make copies of this prospectus (as it may be supplemented or amended from
time to time) available to the selling stockholders for the purpose of
satisfying the prospectus delivery requirements of the Securities Act. The
selling stockholders may indemnify any broker-dealer that participates in
transactions involving the sale of the shares against certain liabilities,
including liabilities arising under the Securities Act.
We
have
agreed to indemnify the selling stockholders against liabilities, including
liabilities under the Securities Act and state securities laws, relating to
the
registration of the shares offered by this prospectus.
We
have
agreed with the selling stockholders to keep the registration statement that
includes this prospectus effective until the earlier of (1) such time as all
of
the shares covered by this prospectus have been disposed of pursuant to and
in
accordance with the registration statement or (2) the date on which the shares
may be sold pursuant to Rule 144 of the Securities Act.
Shares
Eligible For Future Sale
Upon
completion of this offering and assuming the issuance of all of the shares
covered by this prospectus and all other shares that are issuable upon the
exercise or conversion of convertible securities, there will be 19,342,984
shares of our common stock issued and outstanding. The shares purchased in
this
offering will be freely tradable without registration or other restriction
under
the Securities Act, except for any shares purchased by an “affiliate” of our
company (as defined in the Securities Act), pursuant to this prospectus of
Rule
144.
Our
currently outstanding shares that were issued in reliance upon the “private
placement” exemptions provided by the Securities Act are deemed “restricted
securities” within the meaning of Rule 144. Restricted securities may not be
sold unless they are registered under the Securities Act or are sold pursuant
to
an applicable exemption from registration, including an exemption under Rule
144
of the Securities Act.
In
general, under Rule 144 as currently in effect, any person (or persons whose
shares are aggregated) including persons deemed to be affiliates, whose
restricted securities have been fully paid for and held for at least six months
from the later of the date of issuance by us or acquisition from an affiliate,
may sell such securities in broker’s transactions or directly to market makers.
Affiliates may only sell in any three month period that number of shares that
does not exceed the greater of 1 percent of the then-outstanding shares of
our
common stock or the average weekly trading volume of our shares of common stock
in the over-the-counter market during the four calendar weeks preceding the
sale. Sales under Rule 144 are also subject to certain notice requirements
and
the availability of current public information about our company. After one
year
has elapsed from the later of the issuance of restricted securities by us or
their acquisition from an affiliate, such securities may be sold without
limitation by persons who are not affiliates under the rule.
Following
the date of this prospectus, we cannot predict the effect, if any, that sales
of
our common stock or the availability of our common stock for sale will have
on
the market price prevailing from time to time. Nevertheless, sales by existing
stockholders of substantial amounts of our common stock could adversely affect
prevailing market prices for our stock.
DESCRIPTION
OF CAPITAL STOCK
General
Our
certificate of incorporation, as amended to date, authorizes us to issue up
to
200,000,000 shares of Common Stock and 10,000,000 shares of preferred stock.
As
of the date of this prospectus, we have 5,461,644 shares of Common Stock issued
and outstanding, 3,464.5 shares of Series A Convertible Preferred Stock issued
and outstanding, and 3,405.165 shares of Series B Convertible Preferred Stock
issued and outstanding. The transfer agent and registrar for our capital stock
is Wells Fargo Bank Minnesota, N.A., St. Paul, Minnesota. On March 13, 2008,
we
filed a Certificate of Designation with the Secretary of State of the State
of
Delaware establishing our Series A Convertible Preferred Stock and the Series
B
Convertible Preferred Stock.
Common
Stock
Holders
of our Common Stock are entitled to one vote for each share on all matters
to be
voted on by our stockholders. Holders of our Common Stock do not have any
cumulative voting rights. Common stockholders are entitled to share ratably
in
any dividends that may be declared from time to time on the Common Stock by
our
Board of Directors from funds legally available for dividends. Holders of Common
Stock do not have any preemptive right to purchase shares of Common Stock.
There
are no conversion rights or sinking fund provisions for our Common
Stock.
Description
of the Series A Convertible Preferred Stock
Conversion
Ratio
We
issued
an aggregate of 3,464.5 shares of our newly-designated Series A Convertible
Preferred Stock (the “Series A Stock”) on March 14 and April 9, 2008. The
offering price per share of Series A Stock was $1,000. The initial conversion
ratio of the Series A Stock was one share of Common Stock for $0.06 (the “Series
A Conversion Ratio”). The Series A Conversion Ratio is subject to standard
anti-dilution adjustments for corporate events, including but not limited to
stock splits, combinations and recapitalizations. Pursuant to our reverse
1-for-10 stock split, the Series A Conversion Ratio has been adjusted to one
share of Common Stock for $0.60. The Series A Stock shall convert to Common
Stock upon the earlier of (i) the holder’s election to convert the Series A
Stock and the conversion shall occur at a price equal to the Conversion Ratio,
or (ii) the closing sale price of the Common Stock equaling at least $0.38
per
share (or $3.80 per share pursuant to our 1-for-10 reverse stock split), as
adjusted for stock splits, combinations, and similar events, for 20 consecutive
Trading Days and such conversion shall occur at a price equal to the Conversion
Ratio.
Voting
Rights
The
holders of shares of Series A Stock will vote together with all other holders
of
our voting stock on all matters submitted to a vote of holders generally, with
the holder of each share of Series A Stock being entitled to one vote for each
share of Common Stock into which such shares of Series A Stock could then be
converted.
Dividend
The
Series A 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 our option;
provided
,
that
the dividend shall only be payable in shares if such shares are registered
for
resale on an effective registration statement on the date of payment. If we
choose to pay any dividend in shares of Common Stock, the price per share for
purposes of calculating the number of shares 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 payment becomes payable.
“Trading Days” shall mean any day on which the national securities exchange or
quotation service on which the Common Stock is listed or quoted is open for
trading in equity securities.
Anti-Dilution
The
Series A Stock will be protected against dilution if we effect a subdivision
or
combination of our outstanding Common Stock or in the event of a
reclassification, stock dividend, or other distribution payable in our
securities and the Series A Stock has full-ratchet anti-dilution protection,
subject to standard exceptions.
Liquidation
Preference
In
the
event of a liquidation, bankruptcy, dissolution or similar proceeding, the
holders of the Series A Stock shall rank
pari
passu
with the
Series B Stock and shall receive an amount equal to 100% of the original
Offering Price plus any accrued but unpaid dividends (the “Series A Liquidation
Preference”). In the event that we are unable to lawfully pay the Series A
Liquidation Preference and Series B Liquidation Preference, the Series A Stock
shall receive a pro rata share of the assets with the Series B Stock. After
payment of the Series A Liquidation Preference and Series B Liquidation
Preference, the Series A Stock shall then be entitled to receive their pro
rata
share of the remaining assets available for distribution to stockholders on
an
“as if” converted basis, together with the holders of the Common Stock and any
other junior stock.
Redemption
Right
In
the
event that there has not been a voluntary conversion or mandatory conversion
of
the Series A Stock by July 3, 2009, the holders of Series A Stock shall have
a
right to require us to repurchase their Series A Stock out of funds lawfully
available (the “Series A Redemption Right”). The Series A Redemption Right
shall rank
pari
passu
with the
Series B Redemption Right. The redemption price
(the
“Series A Redemption Amount” and, together with the Series B Redemption Amount,
the “Aggregate Redemption Amount”)
shall
equal the Offering Price (subject to appropriate adjustment in the event of
any
stock dividends, stock splits, or other similar event), plus any declared and
unpaid dividends. The Series A Redemption Right shall terminate upon the
closing of a Series B Qualified Financing.
To
the
extent we have insufficient funds as of the date of redemption (the “Redemption
Date”) to pay the Aggregate Redemption Amount in full, we shall redeem the
Series A Stock and the Series B Stock on a pro rata basis.
Description
of the Series B Convertible Preferred Stock
Conversion
of Bridge Notes to Series B Stock
On
March
13, 2008, we converted our outstanding Bridge Notes into our newly-designated
Series B Convertible Preferred Stock (the “Series B Stock”). Our former Bridge
Note Holders received one share of Series B Stock for each $1,000 of unpaid
principal and accrued but unpaid interest on such Holder’s Bridge Note (the
“Series B Price”). Bridge Note Holders shall receive fractional shares of Series
B Stock for any unpaid principal and accrued but unpaid interest in excess
of a
multiple of $1,000 on such Holder’s Bridge Note.
Conversion
Each
share of Series B Stock will be convertible, at the option of the Series B
holder thereof, at any time and from time to time. The initial conversion ratio
of the Series B Stock shall be one share of Common Stock for $0.38, subject
to
adjustment (the “Series B Conversion Ratio”). The Series B Conversion Ratio
shall be subject to standard anti-dilution adjustments for corporate events,
including but not limited to stock splits, combinations and recapitalizations.
Pursuant to our 1-for-10 reverse stock split, the Series B Conversion Ratio
is
now one share of Common Stock for $3.80.
The
Series B Stock shall convert into Common Stock automatically upon the earlier
of: (i) the Closing Sale Price of the Common Stock equaling at least $0.38
per
share (or $3.80 per share pursuant to our 1-for-10 reverse stock split),as
adjusted for stock splits, combinations and similar events) for twenty (20)
consecutive Trading Days and shall convert at such price; (ii) the final closing
of a Series B Qualified Financing, or (iii) the Sale of the Company that does
not occur in connection with Series B Qualified Financing.
A
“Series
B Qualified Financing” means our next equity financing (or series of related
equity financings) in which we receive at least $7,000,000 in gross aggregate
proceeds resulting (before brokers’ fees or other transaction related expenses,
and excluding any such proceeds resulting from this Offering or any transaction
arising hereunder).
In
the
event of the final closing of a Series B Qualified Financing, each share of
Series A Stock and Series B Stock shall be converted to the equity security,
or
the securities convertible or exchangeable into equity securities, offered
in
such financing on the terms and conditions set forth in the Series B Qualified
Financing and at a price equal to the lesser of (a) the lowest price paid per
security in the Series B Qualified Financing, or (b) $0.60 per security (as
adjusted for stock splits, combinations, and similar events).
A
“Sale
of the Company” means a transaction (whether by merger, consolidation, sale or
transfer of our capital stock or otherwise) with one or more non-affiliates,
pursuant to which such party or parties acquire (i) our capital stock possessing
the voting power to elect a majority of our board of directors; or (ii) all
or
substantially all of our assets determined on a consolidated basis;
provided
,
however
,
that a
transaction (or series of related transactions) pursuant to which the
then-existing holders of our capital stock immediately prior to such transaction
(or series of related transactions) continue to own, directly or indirectly,
a
majority of the outstanding shares of our capital stock or such other resulting,
surviving or combined company resulting from such transaction (or series of
related transactions) shall not be deemed to be a “Sale of the Company.” The
price per share with respect to an automatic conversion of the Series B Stock
triggered by a Sale of the Company will be equal to the quotient obtained by
dividing (x) the value of the aggregate consideration (as defined in the
Certificate of Designation of the Series A Convertible Preferred Stock and
Series B Convertible Preferred Stock of VioQuest Pharmaceuticals, Inc.) received
in such Sale of the Company less any of our indebtedness then outstanding by
(y)
the number of shares of Common Stock then outstanding on a fully diluted basis
(not including conversion of the then outstanding shares Series B Stock or
exercise of the then outstanding warrants issued to the Bridge Note Holders
in
connection with their purchase of Bridge Notes).
Series
B Redemption Right
In
the
event that there has not been a voluntary conversion or mandatory conversion
of
the Series B Stock by July 3, 2009, the holders of Series B Stock shall have
a
right to require us to repurchase their Series B Stock out of funds lawfully
available (the “Series B Redemption Right”). The Series B Redemption Right
shall rank
pari
passu
with the
Series A Redemption Right. The redemption price (the “Series B Redemption
Amount”) shall equal the Series B Price (subject to appropriate adjustment in
the event of any stock dividends, stock splits, or other similar event), plus
any declared and unpaid dividends.
To
the
extent we have insufficient funds as of Redemption Date to pay the Aggregate
Redemption Amount in full, we shall redeem the Series A Stock and the Series
B
Stock on a pro rata basis.
Voting
Rights
The
Series B Stock holders will only have those voting rights as set forth in
Delaware General Corporation Law.
Dividend
The
shares of Series B Stock shall be entitled to a dividend, payable in cash or
shares of Common Stock at our option, equal to (i) 8% per annum of the Series
B
Price, commencing on the closing date of the Offering, and accruing through
July
3, 2008, (ii) 12% per annum for the year beginning on July 4, 2008 and ending
on
July 3, 2009, and (iii) thereafter the shares of Series B Stock shall be
entitled to a dividend equal to 16% per annum. If we choose to pay any dividend
in shares of Common Stock, the dividend shall be payable in shares of Common
Stock only if such shares are registered for resale on an effective registration
statement on the date of payment. If we choose to pay any dividend in shares
of
Common Stock, the price per share for purposes of calculating the number of
shares of Common Stock to be issued shall be equal to 90% of the average closing
price of the Common Stock for the twenty (20) Trading Days prior to the date
that such dividend payment becomes payable.
Anti-Dilution
The
Series B Stock will be protected against dilution if we effect a subdivision
or
combination of our outstanding Company Common Stock or in the event of a
reclassification, stock dividend, or other distribution payable in our
securities.
Liquidation
Preference
In
the
event of a liquidation, bankruptcy, dissolution or similar proceeding, the
holders of the Series B Stock shall rank
pari
passu
with the
Series A Stock and shall receive an amount equal to 100% of the Series B Price
plus any accrued but unpaid dividends (the “Series B Liquidation Preference”).
In the event that we are unable to lawfully pay the Series B Liquidation
Preference and the Series A Liquidation Preference, the Series B Stock shall
receive a pro rata share of the assets with the Series A Stock.
Warrants
and Options
As
of the
date of this prospectus, we have 7,211,078 shares of common stock reserved
for issuance under outstanding warrants and options. The exercise prices
applicable to our options range from $0.52 to $19.60 per share and have a
weighted average exercise price of $1.69
.
The exercise
prices applicable to our warrants range from $0.80 to $16.50 per share and
have
a weighted average exercise price of $4.42.
Market
for Common Stock
Since
April 30, 2008, our common stock has traded on the OTC Bulletin Board under
the
symbol “VOQP.OB.” Prior to April 30, 2008, our common stock traded under the
symbol “VQPH.OB.” The following table lists the high and low sale price for our
common stock as quoted by the OTC Bulletin Board during each quarter within
the
last two completed fiscal years and the quarter ended December 31, 2007, as
adjusted pursuant to our 1-for-10 reverse stock split. These quotations reflect
inter-dealer prices, without retail mark-up, markdown, or commission and may
not
represent actual transactions.
Quarter
Ended
|
|
High
|
|
Low
|
|
June
30, 2006
|
|
|
8.00
|
|
|
7.70
|
|
September
30, 2006
|
|
|
6.50
|
|
|
6.00
|
|
December
31, 2006
|
|
|
5.30
|
|
|
4.30
|
|
March
31, 2007
|
|
|
7.50
|
|
|
4.50
|
|
June
30, 2007
|
|
|
6.40
|
|
|
3.60
|
|
September
30, 2007
|
|
|
5.50
|
|
|
2.50
|
|
December
31, 2007
|
|
|
3.70
|
|
|
0.90
|
|
March
31, 2008
|
|
|
2.00
|
|
|
0.50
|
|
June
30, 2008
|
|
|
1.10
|
|
|
0.20
|
|
On
August
4, 2008, the closing sale price of our common stock was
$0.51.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND
RESULTS OF OPERATIONS
You
should read the following discussion of our results of operations and financial
condition in conjunction with the financial statements contained in this
prospectus beginning at page F-1. This discussion includes “forward-looking”
statements that reflect our current views with respect to future events and
financial performance. We use words such as we “expect,”
“anticipate,” “believe,” and “intend” and similar expressions to identify
forward-looking statements. Investors should be aware that actual results may
differ materially from our expressed expectations because of risks and
uncertainties inherent in future events, particularly those risks identified
in
the “Risk Factors” section of this prospectus, and should not unduly rely on
these forward looking statements.
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
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 we
filed
our 510(k) Premarket Notification application with the FDA on June 30, 2008,
seeking marketing clearance 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 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 NDA with the 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.
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)
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.
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.
On
June
30, 2008, we filed an application with the FDA seeking marketing clearance
for
Xyfid. The FDA has 90 days to review our submission and determine whether
Xyfid
is substantially equivalent to a medical device already in commercial
distribution and, if so, to permit us to begin marketing Xyfid. However,
the
FDA’s review process often takes longer than the 90 period and we may be
requested to submit additional information including clinical data. 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.
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)
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.
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
our
current Phase I solid tumor study, 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. Patients had progressive disease
despite receiving a median of 3 prior treatment regimens (range 1-4).
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.
In our
Phase I hematological malignancies study, 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, 45 and 55 mg/m2. Enrollment to higher
doses is ongoing, which we are currently at 65 mg/m2. Patients had progressive
disease despite receiving a median of 3 prior treatment regimens (range 1-4).
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 38 patients have been enrolled at two clinical sites. Twenty-nine
patients are evaluable for toxicity and response, six patients are evaluable
for
toxicity only, and three 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 six patients achieving major improvements in platelet
count lasting up to 36 days and seven patients achieving major improvements
in
neutrophil count lasting up to 40 days while on therapy. VQD-002 was
well-tolerated at the doses studied.
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)
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.
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 five different dose cohorts: 400 mg/m2, 600 mg/m2, 900 mg/m2, 1350
mg/m2 and a dose reduced cohort of 1125 mg/m2. Lenocta with IFN
a
-2b
has
been well tolerated at doses up to 900 mg/m2. We plan to initiate an expansion
phase for 20 patients to have twelve subjects evaluable for response at a dose
of 900 mg/m2.
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.
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, including skin ulcers, partial or total destruction
of the mucus membrane and irregular bouts of fever, substantial weight loss,
swelling of the spleen and liver, and anaemia (occasionally serious). In
collaboration with the U.S. Army, through an executed Cooperative Research
and
Development Agreement, 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.
Overview
of Drug Development Status
To
date,
we have not received approval for the sale of any drug candidates in any market
and, therefore, have not generated any revenues from our drug candidates. The
successful development of our product candidates is highly uncertain. Product
development costs and timelines can vary significantly for each product
candidate and are difficult to accurately predict. Various laws and regulations
also govern or influence the manufacturing, safety, labeling, storage, record
keeping and marketing of each product. The lengthy process of seeking these
approvals, and the subsequent compliance with applicable statutes and
regulations, require the expenditure of substantial resources. Any failure
by us
to obtain, or any delay in obtaining, regulatory approvals could materially
adversely affect our business.
Developing
pharmaceutical products is a lengthy and very expensive process. Assuming we
do
not encounter any unforeseen safety issues during the course of developing
our
product candidates, we do not expect to complete the development of a product
candidate until approximately 2008 for the treatment of leishmaniasis, 2008
for
Xyfid through a 510(k) submission, 2010 for Xyfid through an NDA submission,
and
2013 for oncology indications of VQD-002 and then 2013 for oncology indications
of Lenocta, if ever. In addition, as we continue the development of our product
candidates, our research and development expenses will significantly 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 to increase. 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
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 - For the Three Months Ended March 31, 2008 vs. March 31,
2007
Continuing
Operations
The
Company has had no revenues from its continuing operations through March 31,
2008.
Research
and development, or R&D, expenses for the three months ended March 31, 2008
were $979,094 as compared to $1,368,811 during the three months ended March
31,
2007. R&D expense consists of clinical development costs, milestone license
fees, maintenance fees paid to our licensing institutions, outside manufacturing
costs, outside clinical research organization costs, regulatory and patent
filing costs associated with our three oncology compounds, Lenocta, VQD-002
and
Xyfid.
The
following table sets forth the research and development expenses per compound,
for the periods presented.
|
|
Three Months Ended March 31,
|
|
|
|
2008
|
|
2007
|
|
Cumulative
amounts during
development
|
|
Lenocta
|
|
$
|
285,330
|
|
$
|
456,525
|
|
$
|
3,165,324
|
|
VQD-002
|
|
|
530,613
|
|
|
477,624
|
|
|
3,663,633
|
|
Xyfid
|
|
|
163,151
|
|
|
434,662
|
|
|
958,018
|
|
Total
|
|
$
|
979,094
|
|
$
|
1,368,811
|
|
$
|
7,786,975
|
|
The
following table sets forth the research and development expenses for the three
months ended March 31, 2008 by expense category, for our three oncology
compounds.
|
|
Drug Candidate
|
|
|
|
|
|
Lenocta
|
|
VQD-002
|
|
Xyfid
|
|
Three Months
Ended March
31, 2008
|
|
Clinical
Research Costs
|
|
$
|
160,759
|
|
$
|
217,708
|
|
$
|
104,293
|
|
$
|
482,760
|
|
Labor
Costs
|
|
|
64,403
|
|
|
167,448
|
|
|
25,761
|
|
|
257,612
|
|
Regulatory
/ Legal Fees
|
|
|
51,118
|
|
|
132,907
|
|
|
20,447
|
|
|
204,472
|
|
Licensing
/ Milestone Fees
|
|
|
8,750
|
|
|
6,250
|
|
|
-
|
|
|
15,000
|
|
Other
|
|
|
300
|
|
|
6,300
|
|
|
12,650
|
|
|
19,250
|
|
Total
|
|
$
|
285,330
|
|
$
|
530,613
|
|
$
|
163,151
|
|
$
|
979,094
|
|
The
following table sets forth the research and development expenses for the three
months ended March 31, 2007 by expense category, for our three oncology
compounds.
|
|
Drug Candidate
|
|
|
|
|
|
Lenocta
|
|
VQD-002
|
|
Xyfid
|
|
Three Months
Ended March
31, 2007
|
|
Clinical
Research Costs
|
|
$
|
182,497
|
|
$
|
329,474
|
|
$
|
-
|
|
$
|
511,971
|
|
Labor
Costs
|
|
|
137,227
|
|
|
77,227
|
|
|
-
|
|
|
214,454
|
|
Regulatory
/ Legal Fees
|
|
|
76,864
|
|
|
60,048
|
|
|
37,490
|
|
|
174,402
|
|
Licensing
Fees
|
|
|
8,752
|
|
|
6,250
|
|
|
369,588
|
|
|
384,590
|
|
Other
|
|
|
51,185
|
|
|
4,625
|
|
|
27,584
|
|
|
83,394
|
|
Total
|
|
$
|
456,525
|
|
$
|
477,624
|
|
$
|
434,662
|
|
$
|
1,368,811
|
|
The
decrease in R&D expenses for the three months ended March 31, 2008 as
compared to the three months ended March 31, 2007 is primarily attributable
to
fees incurred during the three months ended March 31, 2007 in acquiring the
worldwide license to certain patents for Xyfid. In addition, there was a
reduction in clinical research costs, offset by increased labor costs and
regulatory and legal fees related to our oncology drug candidates: VQD-002,
Lenocta and Xyfid. Our R&D expense for the first quarter 2008 is primarily
composed of outside clinical research organization costs of $482,760, employee
costs of $257,612 and outside regulatory and legal fees of $204,472, which
have
been allocated to each of our three pharmaceutical product candidates. 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 R&D spending to increase over the remainder of the year
as we continue our existing clinical development programs and incur costs
related to license fees, manufacturing of our products, regulatory costs, and
the hiring of additional people in the clinical development area.
General
and administrative, or G&A, expenses for the three months ended March 31,
2008 were $690,339 as compared to $913,651 during the three months ended March
31, 2007. This decrease in G&A expenses for the three months ended March 31,
2008 as compared to the three months ended March 31, 2007 was primarily due
to
having fewer employees which resulted in reduced employee and non-employee
director stock option expense in accordance with SFAS 123R as a result of
forfeitures, a reduction of bonus expenses over prior year, no recruitment
expenses and no employment agency fees.
Interest
expense, net of interest income for the three months ended March 31, 2008 was
$1,411,548 as compared to interest income, net of interest expense for the
three
months ended March 31, 2007 of $25,684. Interest expense for the three months
ended March 31, 2008 was primarily composed of interest expenses recorded upon
the extinguishment of the Bridge Notes of $1,399,524 and dividends payable
on
mandatorily redeemable convertible preferred stock of $14,947, which was offset
by interest income of $2,923.
Our
loss
from continuing operations for the three months ended March 31, 2008 was
$3,080,981 as compared to $2,256,778 for the three months ended March 31,
2007.
The increased loss from continuing operations for the three months ended
March
31, 2008 as compared to the three months ended March 31, 2007 was attributable
primarily to interest expenses recorded upon the extinguishment of the Bridge
Notes, offset by decreased R&D and G&A expenses. The decrease in R&D
expenses were related to fees incurred during the three months ended March
31,
2007 in acquiring the worldwide license to certain patents for Xyfid. In
addition, there was a reduction in clinical research costs, offset by increased
labor costs and regulatory and legal fees related to our oncology drug
candidates: Lenocta, VQD-002 and Xyfid. The decrease in G&A expenses were
primarily due to having fewer employees which resulted in reduced employee
and
non-employee director stock option expense in accordance with SFAS 123R as
a
result of forfeitures and workforce reductions, a reduction of bonus expenses
and lower recruitment and employment agency fees.
Discontinued
Operation
s
Our
loss
from discontinued operations for the three months ended March 31, 2008 and
2007
was $0 and $261,475, respectively. Their were no discontinued operations
for the
three months ended March 31, 2008 due to the sale of Chiral Quest to Chiral
Quest Acquisition Corp. during the third quarter of 2007.
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 our 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 our 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
|
|
|
825,286
|
|
Licensing
/ Milestone Fees
|
|
|
381,806
|
|
|
25,000
|
|
|
369,588
|
|
|
776,394
|
|
Other
|
|
|
190,973
|
|
|
273,202
|
|
|
196,060
|
|
|
660,235
|
|
Total
|
|
$
|
2,056,598
|
|
$
|
2,136,681
|
|
$
|
794,867
|
|
$
|
4,988,146
|
|
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 our 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, we 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.
Liquidity
and Capital Resources
Since
inception, the Company has incurred an accumulated deficit of $42,513,278
through March 31, 2008. For the three months ended March 31, 2008 and 2007,
the
Company had losses from continuing operations of $3,080,981 and $2,256,778,
respectively, and used $1,060,445 and $1,347,108 of cash in continuing operating
activities for the three months ended March 31, 2008 and 2007, respectively.
For
the three months ended March 31, 2008 and 2007, the Company had a net loss
of
$3,080,981 and a net loss of $2,518,253 (which included $2,256,778 from
continuing operations), respectively. As of March 31, 2008, the Company had
a
working capital deficit of $2,801,606 and cash and cash equivalents of $305,561.
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, 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. Our
current
resources are inadequate to continue to fund operations; therefore, we will
need
to raise capital by the end of the third quarter of 2008 if not sooner.
Furthermore, based upon the amount of capital we are required to raise by
the
end of the third 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. These matters
raise substantial doubt about the ability of the Company to continue as a
going
concern.
On
March
14, 2008, we received gross proceeds of $765,000 from the sale of Series
A
Convertible Preferred Stock. Our cash and cash equivalents at March 31, 2008
reflect the remaining cash proceeds to the Company from this transaction.
On
April 9, 2008, we received gross proceeds of $2,194,500 from a second sale
of
Series A Convertible Preferred Stock.
Management
anticipates that our capital resources will be adequate to fund its operations
into the third quarter of 2008. Additional financing or potential sublicensing
of our rights to our product(s) will be required during the third quarter
of
2008 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 us from third party lenders. 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, maintenance and license fees,
manufacturing costs, patent costs, regulatory approvals and the hiring of
additional employees.
Additional
capital that is urgently needed by us 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 or cease its operations, or enter into
arrangements with collaborative partners or others that may require us to
relinquish rights to certain of its technologies, or potential markets that
we
would not otherwise relinquish.
Contractual
Obligations
License
with The Cleveland Clinic Foundation.
We
have
an exclusive, worldwide license agreement with CCF for the rights to develop,
manufacture, use, commercialize, lease, sell and/or sublicense 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
the
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, we achieved
a
milestone obligation to CCF, from the dosing of our first patient in our
Phase
IIa clinical trial. 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 our 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 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 our 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, we paid to the licensor an aggregate $300,000 for license related
fees, and incurred approximately $37,000 for patent prosecution costs. In
addition, we paid to a third party finder a cash fee of $20,000 and a 5-year
warrant to purchase 30,000 shares of our common stock at an exercise price
of
$5.00 per share, as adjusted for the 1-for-10 reverse stock split. 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. We 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,
we are 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 us to make payments of
up to
an additional $12.5 million in the aggregate upon the achievement of various
commercialization and net sales milestones. We 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 our 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 our common stock. The total principal
obligation is for $3,700,000. In addition, we expect 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.
We 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 we 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, we are 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 our 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 us beginning January 1, 2009. Management does
not
expect that the application of this standard will have any significant effect
on
our 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
our
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 our consolidated financial
statements.
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
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
we filed
our 510(k) Premarket Notification application with the FDA on June 30,
2008
seeking marketing clearance 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 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 NDA with the 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.
C
orporate
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, we sold all of our shares of capital stock of our 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.
On
April
25, 2008, we effected a 1-for-10 reverse stock split of our common stock.
Pursuant to the reverse stock split, all of our warrants, options, and
conversion ratios were adjusted accordingly.
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, 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. 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
We
have
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.
On
June
30, 2008, we filed a 510(k) application with the FDA seeking marketing
clearance
for Xyfid. The FDA has 90 days to review our submission and determine whether
Xyfid is substantially equivalent to a medical device already in commercial
distribution and, if so, to permit us to begin marketing Xyfid. However,
the
FDA’s review process often takes longer than the 90 period and we may be
requested to submit additional information including clinical data. 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.
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-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-2b, week 3 is a rest period, weeks
4 and 5
the patient is dosed with Lenocta and IFN-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-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-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-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-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
|
|
·
|
V
isceral
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. We have 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.
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 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.
Preliminary
Phase I data from our solid tumor study demonstrated that VQD-002 was well
tolerated; one melanoma subject had stable disease for 8 months. Interim
results
of our Phase I hematologic malignancies trials 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.
In
this
study, 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. Patients had progressive disease despite receiving a median
of 3
prior treatment regimens (range 1-4).
Preliminary
results from the 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.
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.
The
key
raw material for Xyfid, our lead product candidate, is uracil. Supply of
uracil
from China is important to our business and, therefore, we are following
closely
the recent evaluations of applicable controls and regulations in China.
Accordingly, we will continue to monitor this situation closely to determine
its
impact, if any, on VioQuest and Xyfid. All of these factors could materially
affect the commercial success of Xyfid.
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:
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preclinical
laboratory tests, animal studies, and formulation
studies,
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·
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submission
to the FDA of an IND for human clinical testing, which must become
effective before human clinical trials may
begin,
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adequate
and well-controlled human clinical trials to establish the safety
and
efficacy of the drug for each
indication,
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submission
to the FDA of an NDA,
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·
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satisfactory
completion of an FDA inspection of the manufacturing facility or
facilities at which the drug is produced to assess compliance with
current
good manufacturing practices, or cGMPs,
and
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FDA
review and approval of the NDA.
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Preclinical
tests include laboratory evaluation of product chemistry, toxicity, and
formulation, as well as animal studies. The conduct of the preclinical tests
and
formulation of the compounds for testing must comply with federal regulations
and requirements. The results of the preclinical tests, together with
manufacturing information and analytical data, are submitted to the FDA as
part
of an IND, which must become effective before human clinical trials may begin.
An IND will automatically become effective 30 days after receipt by the FDA,
unless before that time the FDA raises concerns or questions about issues
such
as the conduct of the trials as outlined in the IND. In such a case, the
IND
sponsor and the FDA must resolve any outstanding FDA concerns or questions
before clinical trials can proceed. We cannot be sure that submission of
an IND
will result in the FDA allowing clinical trials to begin.
Clinical
trials involve the administration of the investigational drug to human subjects
under the supervision of qualified investigators. Clinical trials are conducted
under protocols detailing the objectives of the study, the parameters to
be used
in monitoring safety, and the effectiveness criteria to be evaluated. Each
protocol must be submitted to the FDA as part of the IND.
Clinical
trials typically are conducted in three sequential phases, but the phases
may
overlap. The study protocol and informed consent information for study subjects
in clinical trials must also be approved by an Institutional Review Board
for
each institution where the trials will be conducted. Study subjects must
sign an
informed consent form before participating in a clinical trial. Phase I usually
involves the initial introduction of the investigational drug into people
to
evaluate its short-term safety, dosage tolerance, metabolism, pharmacokinetics
and pharmacologic actions, and, if possible, to gain an early indication
of its
effectiveness. Phase II usually involves trials in a limited patient population
to (i) evaluate dosage tolerance and appropriate dosage; (ii) identify possible
adverse effects and safety risks; and (iii) evaluate preliminarily the efficacy
of the drug for specific indications. Phase III trials usually further evaluate
clinical efficacy and test further for safety by using the drug in its final
form in an expanded patient population. There can be no assurance that Phase
I,
Phase II, or Phase III testing will be completed successfully within any
specified period of time, if at all. Furthermore, we 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
are
pursuing FDA clearance for Xyfid as a medical device pursuant to Section
510(k)
of the Food Drug and Cosmetic Act, or FDCA, and submitted our 510(k) application
on June 30, 2008. 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.
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.
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.
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 above under “Management’s Discussion and Analysis of
Financial Condition and Result of Operations – Contractual
Obligations.”
Employees
and Consultants
As
of
July 21, 2008, we currently have four full-time employees and two consultants.
We anticipate hiring additional full-time employees in the medical and clinical
functions, based upon available financial resources. We intend to and will
continue to use senior advisors, consultants, clinical research organizations
and third parties to perform certain aspects of our products’ development,
manufacturing, clinical and preclinical development, and regulatory and quality
assurance functions. 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.
Environmental
Regulation
We
are
not subject to environmental regulations that have a material effect upon
our
capital expenditures or otherwise.
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 our Chiral Quest Subsidiary, on July 16, 2007,
we
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 we are obligated to pay under
our
lease agreement for such space. If CQAC were to default on payment during
the
sublease agreement’s term, we would be obligated to provide payment to its
landlord on behalf of CQAC through the remainder of the original lease term,
and
we 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 us.
We
believe our existing facilities, as described above, are adequate to meet
our
needs at least through the year ending December 31, 2008.
Legal
Matters
We
are
not currently a party to any material legal proceeding.
MANAGEMENT
AND BOARD OF DIRECTORS
Directors,
Executive Officers and Other Key Employees
The
following table sets forth the name and position of each of our directors and
executive officers:
Name
|
|
Age
|
|
Positions
|
Michael
D. Becker
|
|
39
|
|
Director,
Chief Executive Officer and President
|
Christopher
P. Schnittker
|
|
39
|
|
Chief
Financial Officer and Vice President
|
Stephen
C. Rocamboli
|
|
36
|
|
Director,
non-executive Chairman of Board of Directors and
Secretary
|
Johnson
Y.N. Lau, M.D.
|
|
47
|
|
Director
|
Michael
Weiser, M.D., Ph.D.
|
|
45
|
|
Director
|
Michael
D. Becker, President and Chief Executive Officer
,
joined
VioQuest in November 2007. Previously, he served as President and Chief
Executive Officer at Cytogen Corporation since December 2002. Mr. Becker joined
Cytogen in April 2001 and held positions of increasing responsibility, including
Chief Executive Officer of AxCell Biosciences, a subsidiary of Cytogen focused
on signal transduction pathways, and Vice President of Business Development
and
Industry Relations. During his tenure at Cytogen, Mr. Becker raised in excess
of
$130 million in new capital through both public offerings and private
placements. Prior to joining Cytogen, Mr. Becker was with Wayne Hummer
Investments LLC, a Chicago-based regional brokerage firm from July 1996 to
April
2001, where he held senior positions as a biotechnology analyst, investment
executive and portfolio manager. Mr. Becker was also the founder and Executive
Editor of Beck on Biotech, a monthly biotechnology investment newsletter
published from July 1998 through March 2001. Mr. Becker attended DePaul
University in Chicago, Illinois. Mr. Becker is Chairman of BioNJ, which was
founded in 1994 by New Jersey biotechnology industry CEOs to serve as the voice
of and advocate for the biotechnology industry in New Jersey.
Christopher
P. Schnittker, CPA, Chief Financial Officer and Vice President
,
joined us in July 2008. Prior to VioQuest, Mr. Schnittker served as the Senior
Vice President and Chief Financial Officer for Micromet, Inc., from October
2006
to December 2007. Mr. Schnittker also served as Senior Vice President and
Chief
Financial Officer for Cytogen Corporation, a publicly-traded biopharmaceutical
company, from September 2003 to June 2006. From June 2000 to August 2003,
Mr.
Schnittker was Senior Vice President, Chief Financial Officer, and Corporate
Secretary of Genaera Corporation (formerly Magainin Pharmaceuticals, Inc.).
Mr.
Schnittker received his B.A. degree in Economic and Business, with a
concentration in Accounting, from Lafayette College. Mr. Schnittker is a
certified public accountant licensed in the State of New
Jersey.
Stephen
C. Rocamboli
has
served as our non-executive Chairman since February 2003 and Secretary since
November 2006. He was our Secretary from 2003 to December 2003. Mr. Rocamboli
is
currently President of Pear Tree Pharmaceuticals, Inc. Prior to joining Pear
Tree, Mr. Rocamboli was deputy general counsel of Paramount BioCapital, Inc.
and
Paramount BioCapital Investments, LLC and served as deputy general counsel
of
those companies from September 1999 to August 2007. From November 2002 to
December 2003, Mr. Rocamboli served as director of Ottawa, Ontario based Adherex
Technologies, Inc. Mr. Rocamboli also serves as a member of the board of
directors of several privately held development stage biotechnology companies.
Prior to joining Paramount, Mr. Rocamboli practiced law in the health care
field. He received his J.D. from Fordham University School of Law.
Johnson
Y.N. Lau, M.B.B.S., M.D., F.R.C.P.
,
has
been a member of our board of directors since November 2005. He currently serves
as the Chairman of Kinex Pharmaceuticals, LLC, a position he has held since
December 2003. Dr. Lau currently is a member of the board of directors of
Chelsea Therapeutics International, Ltd. (NASDAQ: CHTP), a publicly-held
company. Prior to his position with Kinex Pharmaceuticals, Dr. Lau was an
independent contractor from January 2003 until December 2003 and served in
various capacities at Ribapharm Inc. from August 2000 until January 2003,
including Chairman, President and Chief Executive Officer. Previously he was
the
Senior Vice President and Head of Research and Development at ICN
Pharmaceuticals and Senior Director of Antiviral Therapy at Schering-Plough
Research Institute. He has published over 200 scientific papers and 40 reviews
and editorials in leading academic journals and was elected as a Fellow, Royal
College of Physicians in 2004. Dr. Lau holds an M.B.B.S. and M.D. from the
University of Hong Kong and the degrees of M.R.C.P. and F.R.C.P. from the Royal
College of Physicians.
Michael
Weiser, M.D., Ph.D
,
is the
founder and co-chairman of Actin Biomed, a New York based healthcare investment
firm advancing the discovery and development of novel treatments for unmet
medical needs. Prior to joining Actin, Dr. Weiser was the Director of Research
at Paramount BioCapital where he was responsible for the scientific, medical
and
financial evaluation of biomedical technologies and pharmaceutical products
under consideration for development. Dr. Weiser completed his Ph.D. in Molecular
Neurobiology at Cornell University Medical College and received his M.D. from
New York University School of Medicine. He performed his post-graduate medical
training in the Department of Obstetrics and Gynecology at New York University
Medical Center. Dr. Weiser also completed a Postdoctoral Fellowship in the
Department of Physiology and Neuroscience at New York University School of
Medicine and received his B.A. in Psychology from University of Vermont. Dr.
Weiser is a member of The National Medical Honor Society, Alpha Omega Alpha.
In
addition, Dr. Weiser has received awards for both academic and professional
excellence and is published extensively in both medical and scientific journals.
Dr. Weiser currently serves on the board of directors of Manhattan
Pharmaceuticals, Inc, Chelsea Therapeutics International, Ltd., Emisphere
Technologies, Inc., Hana Biosciences, Inc., Ziopharm Oncology, Inc. and VioQuest
Pharmaceuticals, Inc. as well as several privately held companies.
EXECUTIVE
COMPENSATION
Summary
Compensation Table
The
following table sets forth all of the compensation awarded to, earned by or
paid
to (i) each individual serving as our principal executive officer during
our last completed fiscal year; and (ii) each other individual that served
as our executive officer at the conclusion of the fiscal year ended
December 31, 2007 and who received in excess of $100,000 in the form of
salary and bonus during such fiscal year (collectively, the “named executives”).
Name and
Principal Position
|
|
Year
|
|
Salary
|
|
Bonus
|
|
Option
Awards (1)
|
|
Non-Equity
Incentive Plan
Compensation
|
|
All Other
Compensation
|
|
Total
|
|
Michael
D. Becker
|
|
|
2007
|
|
$
|
40,894
|
(2)
|
$
|
–
|
|
$
|
45,954
|
(3)
|
$
|
–
|
|
$
|
–
|
|
$
|
86,848
|
|
Chief
Executive Officer and President
|
|
|
2006
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
Edward
C. Bradley, M.D.
|
|
|
2007
|
|
$
|
273,679
|
(4)
|
$
|
–
|
|
$
|
111,013
|
(5)
|
$
|
–
|
|
$
|
–
|
|
$
|
384,692
|
|
Former
Chief Scientific and Medical Officer
|
|
|
2006
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
|
–
|
|
Brian
Lenz
|
|
|
2007
|
|
$
|
185,000
|
|
$
|
–
|
|
$
|
92,542
|
(6)
|
$
|
36,483
|
(7)
|
$
|
–
|
|
$
|
314,025
|
|
Former
Chief Financial Officer and Treasurer
|
|
|
2006
|
|
|
134,583
|
|
|
–
|
|
|
86,546
|
|
|
24,412
|
|
|
3,600
|
(7)
|
|
249,141
|
|
Daniel
E. Greenleaf
|
|
|
2007
|
|
$
|
311,013
|
|
$
|
100,000
|
|
$
|
87,026
|
|
$
|
100,000
|
(9)
|
$
|
–
|
|
$
|
598,039
|
|
Former
Chief Executive Officer and President
(8)
|
|
|
2006
|
|
|
360,000
|
|
|
100,000
|
|
|
818,053
|
|
|
100,000
|
|
|
–
|
|
|
1,378,053
|
|
(1)
|
Amount
reflects the dollar amount recognized for financial statement reporting
purposes for the fiscal year ended December 31, 2007 in accordance
with SFAS 123(R) of stock option awards, and may include amounts
from
awards granted in and prior to fiscal year 2007. Assumptions used
in the
calculation of this amount for employees are identified in Note 8
to our
annual financial statements for the year ended December 31, 2007
included
elsewhere in this prospectus. The number of shares granted by the
stock
option awards described in this table have been adjusted pursuant
to our
1-for-10 reverse stock split on April 25, 2008.
|
(2)
|
Pursuant
to Mr. Becker’s employment agreement dated November 11, 2007, Mr. Becker’s
employment commenced with the Company on November 21, 2007, and is
for a
four year term. Mr. Becker’s annual salary is $358,400.
|
(3)
|
Amount
reflects the dollar amount recognized for financial statement reporting
purposes for the fiscal year ended December 31, 2007 in accordance
with SFAS 123(R), of the following stock option awards: (i) the
vesting of 501,334 share option granted on November 21, 2007 which
vests
in equal installments over four years; and (ii) the vesting of a
portion of shares subject to an option to purchase an aggregate of
85,640
shares granted November 21, 2007 which vests in equal amounts over
four
years, but is subject to vesting to the extent the Company’s shares held
in escrow in connection with our acquisition of Greenwich Therapeutics,
Inc. are released. On December 4, 2007, 29,974 shares of the such
escrowed
shares were released. Thus, 21,410 share options vest on November
21, 2008
and 8,564 vest on November 21, 2009.
|
(4)
|
Pursuant
to Dr. Bradley’s employment agreement dated February 1, 2007, Dr. Bradley
is entitled to receive a salary of $330,000 on an annualized basis.
On
March 20, 2008, Dr. Bradley entered into an agreement with the Company
which provided for a reduction in his base salary from $330,000 to
$165,000. In addition, the agreement provided for a reduction in
the
number of hours of service required to be provided by Dr. Bradley
to the
Company. On April 11, 2008, Dr. Bradley resigned from his part-time
position with the Company.
|
(5)
|
Amount
reflects the dollar amount recognized for financial statement reporting
purposes for the fiscal year ended December 31, 2007 in accordance
with
SFAS 123(R) of the following stock option awards: (i) the vesting
of
one-third of a 70,000 share option granted on February 1, 2007 which
vests
in equal amounts over 3 years.
|
(6)
|
Amount
reflects the dollar amount recognized for financial statement reporting
purposes for the fiscal year ended December 31, 2007 in accordance
with
SFAS 123(R) of the following stock option awards: (i) the vesting
of
one-third of a 2,500 share option granted on April 19, 2004 which
vests in
equal amounts over 3 years; (ii) the vesting of one-third of a 6,000
share
option granted on January 24, 2005 which vests in equal amounts over
3
years; (iii) the vesting of one-third of a 10,000 share option granted
on
November 29, 2005, which vests in equal amounts over 3 years; (iv)
the
vesting of one-third of a 10,000 share option granted on March 31,
2006,
which vests in equal amounts over 3 years; and (v) the vesting of
one-third of a 10,000 share option granted on May 11, 2007, which
vests in
equal amounts over 3 years.
|
(7)
|
Amount
represents a cash bonus awarded based upon the satisfaction of performance
criteria established by our Board of Directors. See “– Employment
Agreements with Named Executives – Brian Lenz – Bonus
Compensation.”
|
(8)
|
Pursuant
to Mr. Greenleaf’s employment agreement, he is entitled to a bonus of
$100,000 upon each anniversary of his agreement. On November 14,
2007, the
Company and Mr. Greenleaf, the Company’s former President & Chief
Executive Officer, entered into a Separation and Release Agreement.
Pursuant to the Separation Agreement, we and Mr. Greenleaf 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.
|
(9)
|
Amount
represents a cash bonus awarded based upon the satisfaction of performance
criteria established by our Board of Directors. See “– Employment
Agreements with Named Executives – Daniel Greenleaf – Bonus
Compensation.”
|
Employment
Agreements with Named Executives
The
following descriptions of our employment agreements with our named executives
contain explanations of bonuses, stock options, and other rights held by our
named executives to receive or purchase our stock. All of the figures included
in the following descriptions have been adjusted pursuant to our 1-for-10
reverse stock split, unless otherwise noted.
Michael
D. Becker
Chief
Executive Officer and President
On
November 11, 2007 we entered into an employment agreement (the “Becker
Agreement”) with Michael D. Becker, our President and Chief Executive Officer.
Pursuant to the agreement, Mr. Becker’s employment with us is for a four year
term, commencing on November 21, 2007. Mr. Becker is entitled to receive an
annual base salary of $358,400. Additionally, the agreement provides that Mr.
Becker is eligible for one-time milestone-based cash bonus payments, as follows:
(i) $150,000 in the event that we receive gross proceeds equal to or in excess
of $10 million as a result of the sale of our securities in one or a series
of
related transactions; (ii) $125,000 upon such time that our market
capitalization exceeds $125 million for a period of fifteen consecutive trading
days, and the average trading volume of our common stock is at least 100,000
shares per trading day; (iii) $500,000 upon such time that our market
capitalization exceeds $250 million for a period of fifteen consecutive trading
days, and the average trading volume of our common stock is at least 200,000
shares per trading day; (iv) $1,000,000 upon such time that our market
capitalization exceeds $500 million for a period of fifteen consecutive trading
days, and the average trading volume of our common stock is at least 300,000
shares per trading day; and (v) $2,000,000 upon such time that our market
capitalization exceeds $1 billion for a period of fifteen consecutive trading
days, and the average trading volume of our common stock is at least 400,000
shares per trading day.
Pursuant
to the Becker Agreement, we also issued to Mr. Becker a ten-year option under
our 2003 Stock Option Plan, to purchase 501,334 shares of our common stock
at an
exercise price of $3.00 per share. The options vests in four equal annual
installments commencing on November 21, 2008. Additionally, pursuant to Mr.
Becker’s employment agreement, we issued 85,640 additional stock options
(referred to as the “Merger Option”) on November 21, 2007, at an exercise of
$3.00 per share. The merger options vest in four equal annual installments
commencing on November 21, 2008, however in addition to such vesting, the Merger
Option is only exercisable to the extent our shares which are held in escrow
in
connection with our acquisition of Greenwich Therapeutics, Inc. in October
2005,
are released. On December 4, 2007, 35% of the escrowed shares were released.
Therefore, 29,974 shares, representing 35% of the Merger Option, vest and are
exercisable as follows: 21,410 shares vest and are exercisable on November
21,
2008, and 8,564 shares vest and are exercisable on November 21,
2009.
Notwithstanding
the 4-year term of the Becker Agreement, either party has the right to terminate
the agreement and Mr. Becker’s employment sooner. In the event we terminate his
employment upon a “change of control” or for a reason other than for “cause”
or
Mr. Becker’s death or disability, or if Mr. Becker terminates his employment for
“good reason,” then we will continue pay to Mr. Becker his base salary and will
provide health insurance coverage for a period of 12 months. In addition, the
unvested portions of the Stock Options that are scheduled to vest on the next
anniversary date of Mr. Becker’s employment shall accelerate and be deemed
vested as of the termination date and shall remain exercisable for a period
of
90 days. However, to the extent any portion of the Merger Option has not become
exercisable because all or a portion of the Greenwich escrowed shares have
not
been released from escrow, then the Merger Option, or any such portion, will
be
forfeited. Notwithstanding the foregoing, if Mr. Becker’s employment is
terminated by us in connection with specified change of control transactions,
then all Stock Options shall accelerate and be deemed vested as of such
termination date. If we terminate Mr. Becker’s employment for “cause” or if Mr.
Becker terminates his employment for a reason other that “good reason,” then we
are only obligated to pay to Mr. Becker his accrued and unpaid base salary
through the date of termination. If Mr. Becker’s employment is terminated as a
result of his death or disability, then we will also pay to Mr. Becker or his
estate his annualized base salary for a period of 6 months and will provide
health insurance for a period of 12 months from such termination.
The
term “cause” under the Becker Agreement means the following conduct or actions
taken by Mr. Becker:
|
·
|
his
willful and repeated failure or refusal to perform his material duties
or
obligations;
|
|
·
|
any
willful, intentional or grossly negligent act having the effect of
injuring, in a material way (whether financial or otherwise), the
Company’s business or reputation;
|
|
·
|
willful
misconduct by in respect of his material duties or obligations;
|
|
·
|
his
indictment of any felony involving a crime of moral turpitude;
|
|
·
|
the
determination by the Company that Mr. Becker engaged in material
harassment or discrimination prohibited by law;
|
|
·
|
any
misappropriation or embezzlement of the Company’s property;
|
|
·
|
a
breach of the non-solicitation, non-competition, invention assignment
and
confidentiality provisions of the Becker Agreement; or
|
|
·
|
a
material breach of any other material provision of the Becker Agreement
that is not cured within 30 days after written notice thereof is
given by
the Company.
|
The
term
“change of control” under the Becker Agreement means any of the following: (A)
the direct or indirect acquisition by a person in one or a series of related
transactions of Company securities representing more than 50% of our combined
voting power; (B) a merger, consolidation, reorganization or share exchange
involving us, or the sale of all or substantially all of our assets, unless
the
beneficial owners of our securities immediately prior to such transaction
continue to hold more than 50% of the combined voting power of the
then-outstanding securities.
The
term
“good reason” means:
|
·
|
a
material reduction by the Company of Mr. Becker’s compensation or
benefits;
|
|
·
|
a
material reduction or change in Mr. Becker’s duties, responsibilities or
position;
|
|
·
|
a
material breach by the Company of any material term of the Becker
Agreement; or
|
|
·
|
a
relocation of the principal place of employment by more than 50 miles
without Mr. Becker’s consent.
|
The
Becker Agreement also provides for customary covenants that preclude Mr. Becker
from disclosing our confidential information, require him to assign certain
inventions to us, restrict his ability to compete with us during his employment
and for a 12-month period thereafter, and prohibit Mr. Becker from soliciting
Company employees to leave our employ during the 12-month period following
his
employment termination.
Christopher
Schnittker, CPA, Chief Financial Officer, joined us in July 2008. Prior to
VioQuest, Mr. Schnittker served as the Senior Vice President and Chief Financial
Officer for Micromet, Inc., from October 2006 to December 2007. Mr. Schnittker
also served as Senior Vice President and Chief Financial Officer for Cytogen
Corporation, a publicly-traded biopharmaceutical company, from September
2003 to
June 2006. From June 2000 to August 2003, Mr. Schnittker was Senior Vice
President, Chief Financial Officer, and Corporate Secretary of Genaera
Corporation (formerly Magainin Pharmaceuticals, Inc.). Mr. Schnittker received
his B.A. degree in Economic and Business, with a concentration in Accounting,
from Lafayette College. Mr. Schnittker is a certified public accountant licensed
in the State of New Jersey.
Christopher
Schnittker
Chief
Financial Officer and Vice President
On
July
18, 2008 we entered into an employment agreement (the “Schnittker Agreement”)
with Christopher Schnittker, our Chief Financial Officer and Vice President.
Pursuant to the agreement, Mr. Schnittker’s employment with us is for a two year
term, commencing on July 21, 2008. Mr. Schnittker is entitled to receive
an
annual base salary of $185,000. Additionally, the agreement provides that
Mr.
Schnittker is eligible for one-time milestone-based cash bonus payment of
$50,000 in the event that we receive gross proceeds equal to or in excess
of $10
million as a result of the sale of our securities in one or a series of related
transactions and a bonus of up to 30% of his annual base salary in the
discretion of Mr. Becker, our Chief Executive Officer.
Pursuant
to the Schnittker Agreement, we also issued to Mr. Schnittker a ten-year
option
under our 2003 Stock Option Plan, to purchase 180,000 shares of our common
stock
at an exercise price equal to fair market value on the date of the grant.
The
options vest in four equal annual installments commencing on July 21, 2009.
Additionally, pursuant to the Schnittker Agreement, we issued 180,000 additional
stock options (referred to as the “Merger Option”) on July 21, 2008, at an
exercise price equal to fair market value on the date of the grant. The merger
options vest in four equal annual installments commencing on July 21, 2009,
however in addition to such vesting, the Merger Option is only exercisable
to
the extent our shares which are held in escrow in connection with our
acquisition of Greenwich Therapeutics, Inc., in October 2005, are released.
Notwithstanding
the 2-year term of the Schnittker Agreement, either party has the right to
terminate the agreement and Mr. Schnittker’s employment sooner. In the event we
terminate his employment upon a “change of control” or for a reason other than
for “cause” or Mr. Schnittker’s death or disability, or if Mr. Schnittker
terminates his employment for “good reason,” then we will continue pay to Mr.
Schnittker his base salary and will provide health insurance coverage for
a
period of 12 months. In addition, the unvested portions of the Stock Options
that are scheduled to vest on the next anniversary date of Mr. Schnittker’s
employment shall accelerate and be deemed vested as of the termination date
and
shall remain exercisable for a period of 90 days. However, to the extent
any
portion of the Merger Option has not become exercisable because all or a
portion
of the Greenwich escrowed shares have not been released from escrow, then
the
Merger Option, or any such portion, will be forfeited. Notwithstanding the
foregoing, if Mr. Schnittker’s employment is terminated by us in connection with
specified change of control transactions, then all Stock Options shall
accelerate and be deemed vested as of such termination date. If we terminate
Mr.
Schnittker’s employment for “cause” or if Mr. Schnittker terminates his
employment for a reason other that “good reason,” then we are only obligated to
pay to Mr. Schnittker his accrued and unpaid base salary through the date
of
termination. If Mr. Schnittker’s employment is terminated as a result of his
death or disability, then we will also pay to Mr. Schnittker or his estate
his
annualized base salary for a period of 6 months and will provide health
insurance for a period of 12 months from such termination.
The
term
“cause” under the Schnittker Agreement means the following conduct or actions
taken by Mr. Schnittker:
|
|
his
willful failure, disregard or refusal to perform his material
duties or
obligations;
|
|
|
any
willful, intentional or grossly negligent act having the effect
of
injuring, in a material way (whether financial or otherwise),
the
Company’s business or reputation;
|
|
|
willful
misconduct by in respect of his material duties or
obligations;
|
|
|
his
indictment of any felony involving a crime of moral
turpitude;
|
|
|
the
determination by the Company that Mr. Schnittker engaged in material
harassment or discrimination prohibited by
law;
|
|
|
any
material misappropriation or embezzlement of the Company’s
property;
|
|
|
a
breach of the non-solicitation, non-competition, invention assignment
and
confidentiality provisions of the Schnittker Agreement;
or
|
|
|
a
material breach of any other material provision of the Schnittker
Agreement that is not cured within 30 days after written notice
thereof is
given by the Company.
|
The
term
“change of control” under the Schnittker Agreement means any of the following:
(A) the direct or indirect acquisition by a person in one or a series of
related
transactions of Company securities representing more than 50% of our combined
voting power; (B) a merger, consolidation, reorganization or share exchange
involving us, or the sale of all or substantially all of our assets, unless
the
beneficial owners of our securities immediately prior to such transaction
continue to hold more than 50% of the combined voting power of the
then-outstanding securities.
The
term
“good reason” means:
|
|
a
material reduction by the Company of Mr. Schnittker’s compensation or
benefits;
|
|
|
a
material reduction or change in Mr. Schnittker’s duties, responsibilities
or position;
|
|
|
a
material breach by the Company of any material term of the Schnittker
Agreement; or
|
|
|
a
relocation of the principal place of employment by more than
50 miles
without Mr. Schnittker’s
consent.
|
The
Schnittker Agreement also provides for customary covenants that preclude
Mr.
Schnittker from disclosing our confidential information, require him to assign
certain inventions to us, restrict his ability to compete with us during
his
employment and for a 12-month period thereafter, and prohibit Mr. Schnittker
from soliciting Company employees to leave our employ during the 12-month
period
following his employment termination.
Edward
C. Bradley
Former
Chief Scientific and Medical Officer
On
February 1, 2007 we entered into an employment agreement with Edward C. Bradley,
M.D., as our Chief Scientific and Medical Officer. The agreement was for an
indefinite term beginning on February 1, 2007 and provided for an initial base
salary of $330,000, plus an annual target bonus of up to 20% of base salary
based upon his personal performance and an additional amount of up to 10% of
base salary based upon Company performance. Pursuant to the employment
agreement, Dr. Bradley received stock options to purchase 70,000 shares of
our
common stock. The options vest in three equal annual installments, commencing
in
February 2008 and will be exercisable at a price per share equal to $5.50.
The
employment agreement also entitled Dr. Bradley to certain severance benefits.
In
the event that we terminated Dr. Bradley’s employment without cause, then Dr.
Bradley was entitled to receive his then annualized base salary for a period
of
six months. If Dr. Bradley’s employment was terminated without cause, and within
a year of a change of control, then Dr. Bradley was entitled to receive his
then
annualized base salary for a period of one year, and he was entitled to receive
any bonuses he has earned at the time of his termination. For the fiscal year
ended December 31, 2007, Mr. Bradley was not entitled to receive any bonus
payout.
On
March
20, 2008, Dr. Bradley entered into an agreement with us to reduce his base
salary from $330,000 to $165,000. In addition, the agreement reduced Dr.
Bradley’s required number of hours of service to us. On April 11, 2008, Dr.
Bradley resigned from his part-time position with us. Pursuant to the terms
of
his employment agreement, stock options representing 23,333 shares of our common
stock vested on February 1, 2008, and the balance of the stock options were
forfeited. However, on April 15, 2008, we agreed to immediately vest an
additional 23,333 shares subject to Dr. Bradley's stock options, so that as
of
April 15, 2008, Dr. Bradley's right to purchase an aggregate of 46,666 shares
subject to his stock option is vested and exercisable. We also extended the
exercise period with respect to Dr. Bradley's options until December 31, 2008.
We have no other obligations to pay Dr. Bradley any further
compensation.
Brian
Lenz
Former
Chief Financial Officer and Treasurer
On
July
21, 2008, Brian Lenz resigned as our Chief Financial Officer and Treasurer
and
became a part-time employee. We did not have a formal employment agreement
with
Mr. Lenz and his resignation did not trigger any obligations under the severance
benefits agreement we had entered into in August 2006. Mr. Lenz had received
several grants of stock options during his service to the Company of which
options representing the right to purchase 53,334 shares had vested as of
July
21, 2008. Pursuant to the terms of our grants of stock options to Mr. Lenz,
all
of his unvested options were to be forfeited on August 14, 2008. However,
on
July 18, 2008, we agreed to vest 93,333 shares subject to Mr. Lenz’s stock
options on August 14, 2008, so that as of that date, Mr. Lenz will have the
right to purchase an aggregate of 146,667 shares of the our common stock.
Furthermore, we extended the exercise period for his options until August
14,
2009.
Bonus
Compensation.
Mr.
Lenz
was also eligible to receive an annual cash bonus upon achievement of certain
performance criteria established by our Board each year. The following table
describes the criteria, the maximum amount for which Mr. Lenz was eligible
to
receive for 2007 for fully satisfying each criterion, and the amount he was
paid
for each such criterion for 2007:
2007
Criteria
|
|
Eligible Amount
|
|
Amount Awarded
|
|
Completion of
financings resulting in gross proceeds of a targeted
amount
|
|
$
|
11,100
|
|
$
|
0
|
|
Listing
of common stock on a national securities exchange
|
|
$
|
16,650
|
|
$
|
0
|
|
Company’s
initiation of 5 Phase II corporate sponsored clinical
trials
|
|
$
|
5,550
|
|
$
|
0
|
|
Chiral
Quest sale process completion
|
|
$
|
16,650
|
|
$
|
16,650
|
|
Qualitative
factors relating to leadership, teamwork, peer interaction, initiative
and
communication
|
|
$
|
5,550
|
|
$
|
0
|
|
Total
|
|
$
|
55,500
|
|
$
|
16,650
|
|
Daniel
Greenleaf
Former
Chief Executive Officer and President
On
November 14, 2007, we and Daniel Greenleaf, our 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 us terminated as of
November 9, 2007, and that Mr. Greenleaf resigned from all positions as officer
and director. The Separation Agreement provides for the following compensation
to be paid to Mr. Greenleaf following his separation from us: (i) Mr. Greenleaf
will 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) we 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 we also released Mr. Greenleaf from the covenant not to compete
contained in his employment agreement with us dated February 1,
2005.
Option
Grants.
Pursuant
to Mr. Greenleaf’s separation agreement, Mr. Greenleaf waived his right to any
stock options that have not vested as of the separation date. Therefore, of
the
total 273,106 options grants issued to Mr. Greenleaf during his employment,
Mr.
Greenleaf forfeited a total of 97,612, and the remaining 175,494 option grants
are exercisable within 12 months of the separation date.
Bonus
Compensation.
Mr.
Greenleaf was also eligible to receive an annual cash bonus upon achievement
of
certain performance criteria established by our Board each year. The following
table describes the criteria, the maximum amount for which Mr. Greenleaf was
eligible to receive for 2007 for fully satisfying each criterion, and the amount
he was paid for each such criterion for 2007:
2007
Criteria
|
|
Eligible Amount
|
|
Amount Awarded
|
|
Completion of financings
resulting in gross proceeds of a targeted amount
|
|
$
|
40,000
|
|
$
|
0
|
|
Listing
of common stock on national securities exchange
|
|
$
|
50,000
|
|
$
|
0
|
|
Company’s
initiation of 5 Phase II corporate sponsored clinical
trials
|
|
$
|
30,000
|
|
$
|
0
|
|
Company’s
completion of enrollment of 3 Phase II clinical trials
|
|
$
|
20,000
|
|
$
|
0
|
|
Acquisition
of a compound as approved by the Board of Directors
|
|
$
|
30,000
|
|
$
|
30,000
|
|
Sale
of Chiral Quest
|
|
$
|
40,000
|
|
$
|
40,000
|
|
Acceptance
of NDA filing for review for Leishmaniasis
|
|
$
|
15,000
|
|
$
|
0
|
|
Qualitative
factors relating to leadership, teamwork, peer interaction, initiative
and
communication
|
|
$
|
25,000
|
|
$
|
0
|
|
Total
|
|
$
|
250,000
|
|
$
|
70,000
|
|
Outstanding
Equity Awards at Fiscal Year-End
The
following table sets forth information regarding each unexercised option held
by
each of our named executive officers as of December 31, 2007. All of the option
awards described in the following table were issued pursuant to our 2003 Stock
Option Plan.
Name
|
|
Number of
Securities
Underlying
Unexercised Options
Exercisable
|
|
Number of
Securities
Underlying
Unexercised Options
Unexercisable
|
|
Option
Exercise Price
|
|
Option
Expiration Date
|
|
Michael
D. Becker
|
|
|
–
|
|
|
501,334
|
(2)
|
$
|
3.00
|
|
|
11/21/2017
|
|
|
|
|
|
|
|
29,974
|
(2)
|
$
|
3.00
|
|
|
11/21/2017
|
|
Brian
Lenz
|
|
|
1,500
|
(3)
|
|
|
|
$
|
16.70
|
|
|
10/06/2013
|
|
|
|
|
2,500
|
(4)
|
|
|
(4)
|
$
|
14.00
|
|
|
04/19/2014
|
|
|
|
|
4,000
|
(5)
|
|
2,000
|
(5)
|
$
|
10.80
|
|
|
01/24/2015
|
|
|
|
|
6,667
|
(6)
|
|
3,333
|
(6)
|
$
|
10.30
|
|
|
11/29/2015
|
|
|
|
|
3,333
|
(7)
|
|
6,667
|
(7)
|
$
|
8.50
|
|
|
03/31/2016
|
|
|
|
|
|
(8)
|
|
10,000
|
(8)
|
$
|
5.50
|
|
|
05/11/2017
|
|
Edward
C. Bradley
|
|
|
|
|
|
70,000
|
(9)
|
$
|
5.50
|
|
|
02/01/2017
|
|
Daniel
Greenleaf
|
|
|
594,264
|
(10)
|
|
|
|
$
|
8.80
|
|
|
11/08/2008
|
|
|
|
|
963,386
|
(10)
|
|
|
|
$
|
8.90
|
|
|
11/08/2008
|
|
|
|
|
197,290
|
(10)
|
|
|
|
$
|
5.60
|
|
|
11/08/2008
|
|
(1)
|
All
options granted pursuant to our 2003 Stock Option
Plan.
|
(2)
|
Options
were granted in accordance with Mr. Becker’s employment agreement dated
November 11, 2007. Pursuant to Mr. Becker’s employment agreement, we
issued 501,334 shares of our common stock, equal to 10% of the outstanding
shares of our common stock at the date of the employment agreement.
Additionally, we issued to Mr. Becker merger options to purchase
85,644
shares of our common stock on the date of the employment agreement,
equal
to 10% of the shares of common stock that have not been released
from
escrow pursuant to the Greenwich Therapeutics, Inc. acquisition in
October
2005. As stated above, 35% of the shares held in escrow were released
on
December 4, 2007, and a commensurate portion of Mr. Becker’s option to
purchase 85,640 immediately vested.
|
(3)
|
Options
were granted on October 6, 2003 and vested in three equal amounts
on each
of October 6, 2004, October 6, 2005 and October 6,
2006.
|
(4)
|
Options
were granted on April 19, 2004 and vested in three equal amounts
on each
of April 19, 2005, April 19, 2006 and April 19, 2007.
|
(5)
|
Options
were granted on January 24, 2005 and vest in three equal amounts
on each
of January 24, 2006, January 24, 2007, and January 24,
2008.
|
(6)
|
Options
were granted on November 29, 2005 and vest in three equal amounts
on each
of November 29, 2006, November 29, 2007, and November 29,
2008.
|
(7)
|
Options
were granted on March 31, 2006 and vest in three equal amounts on
each of
March 31, 2007, March 31, 2008, and March 31,
2009.
|
(8)
|
Options
were granted on May 11, 2007 and vest in three equal amounts on each
of
May 11, 2008, May 11, 2009, and May 11,
2010.
|
(9)
|
Upon
commencement of Dr. Bradley’s employment with us, Dr. Bradley had received
stock options to purchase 70,000 shares of our common stock. The
terms of
his employment agreement provided that stock options representing
23,333
shares of our common stock vested on February 1, 2008, with the balance
of
the stock options to vest in equal installments on February 1, 2009
and
2010. As disclosed above, Dr. Bradley resigned from his position
with us
on April 11, 2008. See “ – Employment Agreements with Named
Executives – Edward C.
Bradley.”
|
(10)
|
Options
vested in accordance with Mr. Greenleaf’s separation agreement with us
dated November 14, 2007.
|
Executive
Compensation under the 2003 Stock Option Plan
As
of
December 31, 2007, we have outstanding 1,350,000 stock options issued under
our 2003 Stock Option Plan, of which 1,013,339 have been issued to the named
executives through December 31, 2007.
Director
Compensation
On
April
5, 2006, our board of directors approved a compensation plan for our outside
directors. Pursuant to the plan, each non-employee director serving on the
board
is entitled to receive $15,000 per year, payable upon reelection to the board
by
the shareholders. Additionally, the chair of the audit committee of the board
shall receive $4,000 yearly and each member of a committee is entitled to
receive $1,000 upon each meeting of a committee. Directors who are also our
employees do not receive compensation for their service on the Board and shall
only receive compensation in their capacities as employees.
The
following table shows the compensation earned by each of our non-employee
directors for the year ended December 31, 2007:
Name
|
|
Fees Earned or
Paid in Cash
|
|
Option
Awards
|
|
All Other
Compensation
|
|
Total
|
|
Vincent M.
Aita (1)
|
|
$
|
17,000
|
|
$
|
12,651
|
(1)
|
$
|
|
|
$
|
29,651
|
|
Johnson
Y.N. Lau
|
|
$
|
20,000
|
|
$
|
76,657
|
(2)
|
$
|
|
|
$
|
96,657
|
|
Stephen
C. Rocamboli
|
|
$
|
17,000
|
|
$
|
18,660
|
(3)
|
$
|
|
|
$
|
35,660
|
|
Stephen
A. Roth (4)
|
|
$
|
17,000
|
|
$
|
60,712
|
(4)
|
$
|
|
|
$
|
77,712
|
|
Michael
Weiser
|
|
$
|
16,000
|
|
$
|
18,660
|
(3)
|
$
|
|
|
$
|
34,660
|
|
Xumu
Zhang (5)
|
|
$
|
|
|
$
|
3,085
|
(5)
|
$
|
45,000
(6
|
)
|
$
|
48,085
|
|
_______________
(1)
|
Mr.
Aita resigned from the Board of Directors on September 10, 2007.
Amount
reflects the dollar amount recognized for financial statement reporting
purposes for the fiscal year ended December 31, 2007, in accordance
with
SFAS 123R, of the award and immediate vesting of one-third of 10,000
options granted on July 11, 2007.
|
(2)
|
Amount
reflects the dollar amount recognized for financial statement reporting
purposes for the fiscal year ended December 31, 2007, in accordance
with
SFAS 123R, of the following stock options awards: (i) the vesting
of
one-third of 17,000 options granted on January 12, 2006 which vest
in
three equal installments beginning on January 12, 2007; (ii) the
vesting
of 7,500 options on March 31, 2007; (iii) the immediate vesting of
one-third of 10,000 options granted on July 11, 2007, and the remaining
two-thirds vest equally on July 11, 2008 and July 11, 2009. Assumptions
used in the calculation of this amount for employees are identified
in Note 8 to our financial statements for the year ended
December 31, 2007 as included in our Form 10-KSB for the year ended
December 31, 2007.
|
(3)
|
Amount
reflects the dollar amount recognized for financial statement reporting
purposes for the fiscal year ended December 31, 2007, in accordance
with
SFAS 123R, of the award of the immediate vesting of one-third of
10,000
options granted on July 11, 2007, and the remaining two-thirds vest
equally on July 11, 2008 and July 11, 2009. Assumptions used in the
calculation of this amount for employees are identified in Note 8 to
our financial statements for the year ended December 31, 2007 as
included in our Form 10-KSB for the year ended December 31,
2007.
|
(4)
|
Mr.
Roth resigned from the Board of Directors on July 16, 2007. Amount
reflects the dollar amount recognized for financial statement reporting
purposes for the fiscal year ended December 31, 2007, in accordance
with
SFAS 123R, of the following stock option awards: (i) the vesting
of
one-third of 120,000 options granted on January 12, 2006 on January
12,
2007. Assumptions used in the calculation of this amount for employees
are
identified in Note 8 to our financial statements for the year
ended December 31, 2007 as included in our Form 10-KSB for the year
ended
December 31, 2007.
|
(5)
|
Mr.
Zhang resigned from the Board of Directors on July 16, 2007. Amount
reflects the dollar amount recognized for financial statement reporting
purposes for the fiscal year ended December 31, 2007, in accordance
with
SFAS 123R, of the vesting of one-quarter of 65,005 options on June
15,
2007 that represented the last annual installment of the option granted
on
June 15, 2003. Assumptions used in the calculation of this amount
for
employees are identified in Note 8 to our financial statements
for the year ended December 31, 2007 as included in our Form 10-KSB
for
the year ended December 31, 2007.
|
(6)
|
Dr.
Zhang entered into a Consulting Agreement with us on May 15, 2003,
which
expired May 14, 2007, by which Dr. Zhang provides consulting services
for
us and received an annual consulting fee of $120,000, payable in
bi-monthly installments.
|
Compensation
Committee Interlocks and Insider Participation
There
were no interlocks or other relationships with other entities among our
executive officers and directors that are required to be disclosed under
applicable SEC regulations relating to compensation committee interlocks and
insider participation.
Limitation
of Liability and Indemnification of Officers and
Directors
Under
our
Amended and Restated Certificate of Incorporation, as amended, we are required
to indemnify and hold harmless, to the fullest extent permitted by law, each
person (a “Covered Person”) who was or is made or is threatened to be made a
party or is otherwise involved in any action, suit or proceeding, whether civil,
criminal, administrative or investigative (a “Proceeding”), by reason of the
fact that he or she, or a person for whom he or she is the legal representative,
is or was a director or officer of ours or, while a director or officer of
ours,
is or was serving at our request as a director, officer, employee or agent
of
another corporation or of a partnership, joint venture, trust, enterprise or
nonprofit entity, including service with respect to employee benefit plans,
against all liability and loss suffered and expenses (including attorneys’ fees)
reasonably incurred by such Covered Person. Notwithstanding the preceding
sentence, except as otherwise provided in the certificate of incorporation,
we
are required to indemnify a Covered Person in connection with a Proceeding
(or
part thereof) commenced by such Covered Person only if the commencement of
such
Proceeding (or part thereof) by the Covered Person was authorized by our Board
of Directors.
In
addition, as permitted
by
Delaware law, our certificate of incorporation provides that no director will
be
liable to us or to our stockholders for monetary damages for breach of certain
fiduciary duties as a director. The effect of this provision is to restrict
our
rights and the rights of our stockholders in derivative suits to recover
monetary damages against a director for breach of certain fiduciary duties
as a
director, except that a director will be personally
liable
for:
|
·
|
any
breach of his or her duty of loyalty to us or our
stockholders
|
|
·
|
acts
or omissions not in good faith which involve intentional misconduct
or a
knowing violation of law
|
|
·
|
the
payment of dividends or the redemption or purchase of stock in violation
of Delaware law; or
|
|
·
|
any
transaction from which the director derived an improper personal
benefit.
|
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
AND
MANAGEMENT
The
following table sets forth certain information regarding the ownership of
our
common stock as of July 31, 2008 by: (i) each director and nominee for director;
(ii) each of our current executive officers; (iii) all of our directors and
executive officers as a group; (iv) all those known by us to be beneficial
owners of at least five percent of our common stock; and (v) as adjusted
for our
1-for-10 reverse stock split. Beneficial ownership is determined under rules
promulgated by the SEC. Under those rules, beneficial ownership includes
any
shares as to which the individual has sole or shared voting power or investment
power and also any shares which the individual has the right to acquire within
60 days of the date hereof, through the exercise or conversion of any stock
option, convertible security, warrant or other right. Inclusion of shares
in the
table does not, however, constitute an admission that the named shareholder
is a
direct or indirect beneficial owner of those shares. Unless otherwise indicated,
each person or entity named in the table has sole voting power and investment
power (or shares that power with that person’s spouse) with respect to all
shares of capital stock listed as owned by that person or entity. Unless
otherwise indicated, the address of each of the following persons is 180
Mount
Airy Road, Suite 102, Basking Ridge, New Jersey 07920.
Name
and Address
|
|
Number of Shares
Beneficially Owned
(1)
|
|
Percentage
of Class
|
|
Michael
D. Becker
|
|
|
11,667
|
(1)
|
|
*
|
|
Christopher
P. Schnittker
|
|
|
0
|
(2)
|
|
-
|
|
Stephen
C. Rocamboli
|
|
|
129,177
|
(3)
|
|
*
|
|
Michael
Weiser, M.D., Ph.D.
|
|
|
230,497
|
(4)
|
|
1.2
|
|
Edward
C. Bradley, M.D.
|
|
|
47,667
|
(5)
|
|
*
|
|
Johnson
Y.N. Lau, M.D., Ph.D.
|
|
|
66,334
|
(6)
|
|
*
|
|
All
Executive Officers and Directors as a group (6 persons)
|
|
|
485,342
|
|
|
|
|
Lester
Lipschutz
|
|
|
1,054,136
|
|
|
6.6
|
|
1650
Arch Street
–
22
nd
Floor
Philadelphia,
PA 19103
|
|
|
|
|
|
|
|
Lindsay
A. Rosenwald
|
|
|
1,886,002
|
|
|
11.6
|
|
787
7
th
Avenue, 48
th
Floor
New
York, NY 10019
|
|
|
|
|
|
|
|
*
Less
than 1%.
(1)
|
Represents:
(i) 5,000 shares purchased on January 14, 2008; and (ii) 20,000
shares
issuable upon exercise of an option (at a price of $0.54 per share),
6,667
shares of which were vested as of June 13,
2008.
|
(2)
|
Represents:
(i) 180,000 shares issuable upon an exercise of an option (at a price
of
$0.52 per share), none of which were vested as of July 31,
2008.
|
(3)
|
Represents:
(i) 71,936 shares owned by, and 14,400 shares issuable upon the
exercise
of two warrants held by, Stephen C. Rocamboli as Trustee for The
Stephen
C. Rocamboli April 2005 Trust u/a/d April 7, 2005; (ii) 1,290 shares
issuable upon exercise (at a price of $0.54 per share) of an option
which
fully vested on October 28, 2006; (iii) 10,000 shares issuable
upon
exercise (at a price of $0.54 per share) of an option, 6,667 shares
of
which were vested as of July 11, 2008; (iv) 1,550 shares purchased
on
January 14, 2008; and (v) 100,000 shares issuable upon exercise
of an
option (at a price of $0.54 per share), 33,334 shares of which
were vested
as of June 13, 2008.
|
(4)
|
Represents:
(i) 161,206 shares of common stock; (ii) 28,000 shares issuable
upon the
exercise of a warrant; (iii) 1,290 shares issuable upon exercise
of an
option (at a price of $0.54 per share) which fully vested on October
28,
2006; (iv) 10,000 shares issuable upon exercise of an option (at
a price
of $0.54 per share), 6,667 shares were vested as of July 11, 2008;
(v)
100,000 shares issuable upon exercise of an option (at a price
of $0.54
per share), 33,334 shares of which were vested as of June 13, 2008;
(vi)
10.57 shares of Series B Convertible Preferred Stock which convert
into
2,781 shares of common stock; and (vii) 657 shares issuable upon
exercise
of a warrants (at a price of
$4.00).
|
(5)
|
Represents:
(i) 1,000 shares purchased on February 7, 2007; and (ii) shares issuable
upon exercise (at a price of $5.50 per share) of an option, 46,666
of
which were vested as of April 15,
2008.
|
(6)
|
Represents:
(i) 17,000 shares issuable upon exercise of an option (at a price
of $0.54
per share), 11,333 shares of which were vested as of January 12,
2008;
(ii) 15,000 shares issuable upon exercise of an option (at a price
of
$0.54 per share), all of which were fully vested on March 31, 2008;
(iii)
10,000 shares issuable upon exercise of an option (at a price of
$0.54 per
share), 6,667 shares of which vested on July 11, 2008; and (iv)
100,000
shares issuable upon exercise of an option (at a price of $0.54
per
share), 33,334 of which were vested as of June 13,
2008.
|
(7)
|
Based
on Schedule 13G filed with the SEC on August 1, 2007. Represents
shares
owned equally by several trusts established for the benefit of Dr.
Lindsay
A. Rosenwald or members of his immediate family, for which Mr. Lipschutz
is the trustee/investment manager, and over which he has voting control
and investment power.
|
(8)
|
Based
on a Schedule 13G/A filed February 13, 2008, and includes (i) 392,319
shares issuable upon the exercise of warrants; (ii) 39,283 shares
held by
Paramount BioCapital Investments, LLC of which Dr. Rosenwald is the
managing member. In addition, this total includes 500 shares of Series
A
convertible stock and warrants held by Capretti Grandi, LLC, of which
Dr.
Rosenwald is a controlling executive, which convert into 833,333
shares of
common stock and 416,667
warrants.
|
TRANSACTIONS
WITH RELATED PERSONS, PROMOTERS AND CERTAIN CONTROL
PERSONS
Transactions
with Related Persons
We
engaged Paramount BioCapital, Inc., (“Paramount”) as our placement agent during
our 2007 and 2008 financings. Lindsay A. Rosenwald, M.D., is the Chairman,
CEO
and sole stockholder of Paramount and a substantial stockholder of our
stock. We paid commissions of $119,700 and issued 45,000 warrants to Paramount
in connection with the 2007 financing, and paid commissions of $207,200 and
issued 492,416 warrants to Paramount in connection with this offering. Dr.
Rosenwald also participated in this offering through a family investment
partnership, of which he is the managing member. The family investment
partnership purchased 500 shares of Series A Preferred Stock and received
warrants to purchase 416,667 shares of common stock.
MATERIAL
CHANGES
On
April
25, 2008, we effected a 1-for-10 reverse stock split. Upon the effective time
of
the split, each shareholder owning 10 shares of pre-split common stock received
one share of post-split common stock. In lieu of fractional shares, each record
holder of securities as of the effective time, who would otherwise have been
entitled to receive a fractional security is entitled to, upon surrender of
such
holder's certificates representing pre-split securities, a cash payment (without
interest) in lieu thereof. The reverse stock split was approved by our
shareholders at our annual meeting on May 24, 2007.
On
July
8, 2008, we amended our escrow agreement, dated October 18, 2005, by and
among
us, J. Jay Lobell (the “Stockholders’ Representative”), U.S. Bank National
Association (the “Escrow Agent”) and Greenwich Therapeutics, Inc., to extend the
escrow termination date until June 30, 2009. The amendment was made effective
as
of June 30, 2008, and replaced the original escrow termination date of the
same
date. We received a copy of a claim, dated June 25, 2008, from the Stockholders’
Representative to the Escrow Agent requesting the release of a portion of
our
securities held by the Escrow Agent arising upon our achievement of a milestone.
We disputed the achievement of the milestone and the parties resolved the
dispute by entering into the amendment. All other obligations set forth in
the
original escrow agreement remain in full force and effect.
WHERE
YOU CAN FIND MORE INFORMATION
Federal
securities law requires us to file information with the SEC concerning our
business and operations. Accordingly, we file annual, quarterly, and special
reports, proxy statements and other information with the SEC. You can inspect
and copy this information at the Public Reference Facility maintained by the
SEC
at Judiciary Plaza, 100 F Street, N.E., Washington, D.C. 20549. You can receive
additional information about the operation of the SEC’s Public Reference
Facilities by calling the SEC at 1-800-SEC-0330. The SEC also maintains a web
site at
http://www.sec.gov
that
contains reports, proxy and information statements and other information
regarding companies that, like us, file information electronically with the
SEC.
VALIDITY
OF COMMON STOCK
Legal
matters in connection with the validity of the shares offered by this prospectus
will be passed upon by Maslon Edelman Borman & Brand, LLP, Minneapolis,
Minnesota.
EXPERTS
The
consolidated financial statements of VioQuest Pharmaceuticals, Inc., as of
December 31, 2007 and 2006, and for the years then ended, included in this
prospectus, have been included herein in reliance on the report, which includes
an explanatory paragraph relating to our ability to continue as a going concern,
of J.H. Cohn LLP, independent registered public accounting firm, given on the
authority of that firm as experts in accounting and auditing.
DISCLOSURE
OF COMMISSION POSITION ON INDEMNIFICATION
OR
SECURITIES ACT LIABILITIES
Insofar
as indemnification for liabilities arising under the Securities Act of 1933
may
be permitted to directors, officers or persons controlling the registrant
pursuant to the foregoing provisions, the registrant has been informed that
in
the opinion of the Securities and Exchange Commission such indemnification
is
against public policy as expressed in the Act and is therefore
unenforceable.
VioQuest
Pharmaceuticals, Inc.
Index
to Consolidated Financial Statements and Information
Unaudited
Interim Condensed Consolidated Financial Statements of VioQuest
Pharmaceuticals, Inc., and Subsidiaries:
|
|
Condensed
Consolidated Balance Sheets as of March 31, 2008 and December 31,
2007
|
F-2
|
Condensed
Consolidated Statements of Operations for the Three Months Ended
March 31,
2008 and 2007
|
F-3
|
Condensed
Consolidated Statements of Changes in Stockholders’ Equity for the Three
Months Ended March 31, 2008
|
F-4
|
Condensed
Consolidated Statements of Cash Flows for the Three Months Ended
March 31,
2008 and 2007
|
F-5
|
Notes
to Condensed Consolidated Financial Statements
|
F-6
|
|
|
Audited
Consolidated Financial Statements of VioQuest Pharmaceuticals, Inc.,
and
Subsidiaries
|
|
Report
of J.H. Cohn LLP
|
F-14
|
Consolidated
Balance Sheets as of December 31, 2007 and 2006
|
F-15
|
Consolidated
Statements of Operations for the Years Ended December 31, 2007 and
2006
|
F-16
|
Consolidated
Statements of Changes in Stockholders’ Equity (Deficiency) for the Years
Ended
December
31, 2007 and 2006
|
F-17
|
Consolidated
Statements of Cash Flows for the Years Ended December 31, 2007 and
2006
|
F-18
|
Notes
to Consolidated Financial Statements
|
F-19
|
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
AS
OF MARCH 31, 2008 (UNAUDITED) AND DECEMBER 31, 2007
|
|
March 31, 2008
(Unaudited)
|
|
December 31, 2007
(Note 1A)
|
|
ASSETS
|
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
305,561
|
|
$
|
694,556
|
|
Prepaid
clinical research costs
|
|
|
287,055
|
|
|
189,359
|
|
Deferred
financing costs
|
|
|
-
|
|
|
357,581
|
|
Other
current assets
|
|
|
57,925
|
|
|
66,836
|
|
Total
Current Assets
|
|
|
650,541
|
|
|
1,308,332
|
|
|
|
|
|
|
|
|
|
PROPERTY
AND EQUIPMENT, NET
|
|
|
32,464
|
|
|
34,789
|
|
SECURITY
DEPOSITS
|
|
|
15,232
|
|
|
15,232
|
|
TOTAL
ASSETS
|
|
$
|
698,237
|
|
$
|
1,358,353
|
|
|
|
|
|
|
|
|
|
LIABILITIES,
MANDATORILY REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS'
DEFICIENCY
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,635,869
|
|
$
|
1,873,500
|
|
Accrued
compensation and related taxes
|
|
|
|
|
|
373,460
|
|
Other
accrued expenses
|
|
|
|
|
|
665,273
|
|
Convertible
notes, net of unamortized debt discount of $0 and $917,612
|
|
|
-
|
|
|
2,930,388
|
|
TOTAL
LIABILITIES
|
|
|
3,452,147
|
|
|
5,842,621
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MANDATORILY
REDEEMABLE CONVERTIBLE PREFERRED STOCK; $0.001 par value: 10,000,000
shares authorized
|
|
|
|
|
|
|
|
Series
A mandatorily redeemable convertible preferred stock; 765 shares
issued
and outstanding at March 31, 2008
|
|
|
6,321
|
|
|
-
|
|
Series
B mandatorily redeemable convertible preferred stock; 3,910 shares
issued
and outstanding at March 31, 2008
|
|
|
3,910,165
|
|
|
-
|
|
Dividends
payable in shares of common stock
|
|
|
14,947
|
|
|
-
|
|
TOTAL
MANDATORILY REDEEMABLE CONVERTIBLE PREFERRED
STOCK
|
|
|
3,931,433
|
|
|
-
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
DEFICIENCY
|
|
|
|
|
|
|
|
Common
stock; $0.001 par value: 200,000,000 shares authorized, 5,462,112
shares
issued and outstanding
|
|
|
5,462
|
|
|
5,462
|
|
Additional
paid-in capital
|
|
|
35,822,473
|
|
|
34,942,567
|
|
Accumulated
deficit
|
|
|
(42,513,278
|
)
|
|
(39,432,297
|
)
|
Total
Stockholders' Deficiency
|
|
|
(6,685,343
|
)
|
|
(4,484,268
|
)
|
TOTAL
LIABILITIES, MANDATORILY REDEEMABLE CONVERTIBLE PREFERRED STOCK
AND
STOCKHOLDERS' DEFICIENCY
|
|
$
|
698,237
|
|
$
|
1,358,353
|
|
See
accompanying notes to condensed consolidated financial
statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR
THE THREE MONTHS ENDED MARCH 31, 2008 AND 2007
(UNAUDITED)
|
|
For the Three
Months
Ended
March 31,
2008
|
|
For the Three
Months Ended
March 31, 2007
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
Research
and development
|
|
$
|
979,094
|
|
$
|
1,368,811
|
|
General
and administrative
|
|
|
690,339
|
|
|
913,651
|
|
Total
Operating Expenses
|
|
|
1,669,433
|
|
|
2,282,462
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS
|
|
|
(1,669,433
|
)
|
|
(2,282,462
|
)
|
|
|
|
|
|
|
|
|
INTEREST
(EXPENSE) / INCOME, NET
|
|
|
(1,411,548
|
)
|
|
25,684
|
|
|
|
|
|
|
|
|
|
LOSS
FROM CONTINUING OPERATIONS
|
|
|
(3,080,981
|
)
|
|
(2,256,778
|
)
|
|
|
|
|
|
|
|
|
LOSS
FROM DISCONTINUED OPERATIONS
|
|
|
-
|
|
|
(261,475
|
)
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
$
|
(3,080,981
|
)
|
$
|
(2,518,253
|
)
|
|
|
|
|
|
|
|
|
NET
LOSS PER COMMON SHARE:
|
|
|
|
|
|
|
|
CONTINUING
OPERATIONS
|
|
$
|
(0.63
|
)
|
$
|
(0.49
|
)
|
DISCONTINUED
OPERATIONS
|
|
|
-
|
|
|
(0.06
|
)
|
|
|
|
|
|
|
|
|
NET
LOSS PER SHARE – BASIC AND DILUTED
|
|
$
|
(0.63
|
)
|
$
|
(0.55
|
)
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING – BASIC AND DILUTED
|
|
|
4,905,426
|
|
|
4,605,672
|
|
See
accompanying notes to condensed consolidated financial
statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS'
DEFICIENCY
FOR
THE THREE MONTHS ENDED MARCH 31, 2008
(UNAUDITED)
|
|
Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated
Deficit
|
|
Total
Stockholders'
Deficiency
|
|
|
|
Shares
|
|
Amount
|
|
Balance, January
1, 2008
|
|
|
5,462,112
|
|
$
|
5,462
|
|
$
|
34,942,567
|
|
$
|
(39,432,297
|
)
|
$
|
(4,484,268
|
)
|
Net
loss for the three months ended March 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
(3,080,981
|
)
|
|
(3,080,981
|
)
|
Value
of warrants issued to placement agents with March 14, 2008 Series
A
mandatorily redeemable convertible preferred stock
|
|
|
|
|
|
|
|
|
140,164
|
|
|
|
|
|
140,164
|
|
Value
of warrants issued to investors and beneficial conversion feature
embedded
in Series A mandatorily redeemable convertible preferred
stock
|
|
|
|
|
|
|
|
|
531,286
|
|
|
|
|
|
531,286
|
|
Accretion
of discount on Series A mandatorily redeemable convertible preferred
stock
|
|
|
|
|
|
|
|
|
(6,321
|
)
|
|
|
|
|
(6,321
|
)
|
Discount
on convertible notes
|
|
|
|
|
|
|
|
|
62,166
|
|
|
|
|
|
62,166
|
|
Stock-based
compensation to employees
|
|
|
|
|
|
|
|
|
152,599
|
|
|
|
|
|
152,599
|
|
Stock-based
compensation to consultants and finder
|
|
|
|
|
|
|
|
|
12
|
|
|
|
|
|
12
|
|
Balance,
March 31, 2008
|
|
|
5,462,112
|
|
$
|
5,462
|
|
$
|
35,822,473
|
|
$
|
(42,513,278
|
)
|
$
|
(6,685,343
|
)
|
See
accompanying notes to condensed consolidated financial
statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR
THE THREE MONTHS ENDED MARCH 31, 2008 AND 2007
(UNAUDITED)
|
|
For the Three
Months Ended
March 31, 2008
|
|
For the Three
Months Ended
March 31, 2007
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(3,080,981
|
)
|
$
|
(2,518,253
|
)
|
Loss
from discontinued operations
|
|
|
-
|
|
|
261,475
|
|
Loss
from continuing operations
|
|
|
(3,080,981
|
)
|
|
(2,256,778
|
)
|
Adjustments
to reconcile loss from continuing operations to net cash used in
continuing operating activities:
|
|
|
|
|
|
|
|
Depreciation
|
|
|
2,325
|
|
|
2,307
|
|
Stock-based
compensation to employees
|
|
|
152,599
|
|
|
221,771
|
|
Stock-based
compensation to consultants and finder
|
|
|
12
|
|
|
53,178
|
|
Amortization
of debt discount and deferred financing fees
|
|
|
1,399,524
|
|
|
-
|
|
Dividends
payable on mandatorily redeemable convertible preferred
stock
|
|
|
14,947
|
|
|
-
|
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
Prepaid
clinical research costs
|
|
|
(97,696
|
)
|
|
17,215
|
|
Other
assets
|
|
|
8,911
|
|
|
(100,907
|
)
|
Accounts
payable
|
|
|
762,369
|
|
|
759,403
|
|
Accrued
expenses
|
|
|
(222,455
|
)
|
|
(43,297
|
)
|
Net
Cash Used in Continuing Operating Activities
|
|
|
(1,060,445
|
)
|
|
(1,347,108
|
)
|
Net
Cash Used in Discontinued Operating Activities:
|
|
|
-
|
|
|
(342,098
|
)
|
Net
Cash Used in Operating Activities
|
|
|
(1,060,445
|
)
|
|
(1,689,206
|
)
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
Payments
for purchased equipment
|
|
|
-
|
|
|
(2,277
|
)
|
Net
Cash Used in Continuing Investing Activities
|
|
|
-
|
|
|
(2,277
|
)
|
Net
Cash Used in Discontinued Investing Activities:
|
|
|
-
|
|
|
(23,555
|
)
|
Net
Cash Used in Investing Activities
|
|
|
-
|
|
|
(25,832
|
)
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
Proceeds
from issuance of mandatorily redeemable convertible preferred stock
with
warrants, net of cash costs of $93,550
|
|
|
671,450
|
|
|
-
|
|
Repayment
of note payable
|
|
|
-
|
|
|
(75,000
|
)
|
Net
Cash Provided By / (Used in) Continuing Financing
Activities
|
|
|
671,450
|
|
|
(75,000
|
)
|
|
|
|
|
|
|
|
|
NET
DECREASE IN CASH AND CASH EQUIVALENTS
|
|
|
(388,995
|
)
|
|
(1,790,038
|
)
|
CASH
AND CASH EQUIVALENTS – BEGINNING OF PERIOD
|
|
|
694,556
|
|
|
2,931,265
|
|
CASH
AND CASH EQUIVALENTS – END OF PERIOD
|
|
$
|
305,561
|
|
$
|
1,141,227
|
|
|
|
|
|
|
|
|
|
Supplemental
Schedule of Non-Cash Investing and Financing
Activities:
|
|
|
|
|
|
|
|
Value
of warrants issued to the placement agent in connection with issuance
of
mandatorily redeemable convertible preferred stock
|
|
$
|
140,164
|
|
$
|
-
|
|
Value
of beneficial conversion feature related to mandatorily redeemable
convertible preferred stock
|
|
$
|
531,286
|
|
$
|
-
|
|
Conversion
of convertible notes into mandatorily redeemable convertible series
B
preferred stock
|
|
$
|
3,910,165
|
|
$
|
-
|
|
See
accompanying notes to condensed consolidated financial
statements.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2008 (UNAUDITED)
NOTE
1
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES AND LIQUIDITY
(A)
Basis of Presentation
The
accompanying unaudited condensed consolidated financial statements have been
prepared in accordance with accounting principles generally accepted in the
United States of America for interim financial information and the rules
and
regulations of the Securities and Exchange Commission. Accordingly, the
financial statements do not include all information and footnotes required
by
accounting principles generally accepted in the United States of America
for
complete annual financial statements. In the opinion of management, the
accompanying unaudited condensed consolidated financial statements reflect
all
adjustments, consisting of only normal recurring adjustments, considered
necessary for a fair presentation. Interim operating results are not necessarily
indicative of results that may be expected for the year ending December 31,
2008
or for any subsequent period. These unaudited condensed consolidated financial
statements should be read in conjunction with the audited consolidated financial
statements included in the Annual Report on Form 10-KSB of VioQuest
Pharmaceuticals, Inc. for the year ended December 31, 2007. The accompanying
condensed consolidated balance sheet as of December 31, 2007 has been derived
from the audited balance sheet as of that date included in the Form 10-KSB.
References to the “Company,” the “Registrant,” “we,” “us,” “our” or in this
Quarterly Report on Form 10-Q 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 cream that we are developing 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 and
to
treat 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. Lenocta™, previously referred to as VQD-001,
or sodium stibogluconate, is our trademark for our oncology product candidate.
All other trademarks and trade names mentioned in this Form 10-Q are the
property of their respective owners.
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.
Our formerly wholly-owned, discontinued subsidiary, Chiral Quest, Ltd., Jiashan
China’s functional currency 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
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 in the third quarter of 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 2
for a complete discussion on discontinued operations.
The
consolidated balance sheets as of December 31, 2007 and the consolidated
statements of operations for the three months ended March 31, 2008 and 2007
include reclassifications to reflect discontinued operations.
(B)
Nature of Operations
Since
August 2004, the Company has focused on acquiring technologies for purposes
of
development and commercialization of pharmaceutical drug candidates in the
areas
of supportive care products, 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.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2008 (UNAUDITED)
(C)
Liquidity
Since
inception, the Company has incurred an accumulated deficit of $42,513,278
through March 31, 2008. For the three months ended March 31, 2008 and 2007,
the
Company had losses from continuing operations of $3,080,981 and $2,256,778,
respectively, and used $1,060,445 and $1,347,108 of cash in continuing operating
activities for the three months ended March 31, 2008 and 2007, respectively.
For
the three months ended March 31, 2008 and 2007, the Company had a net loss
of
$3,080,981 and a net loss of $2,518,253 (which included $2,256,778 from
continuing operations), respectively. As of March 31, 2008, the Company had
a
working capital deficit of $2,801,606 and cash and cash equivalents of $305,561.
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, 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. Our
current
resources are inadequate to continue to fund operations; therefore, we will
need
to raise capital by the end of the third quarter of 2008 if not sooner.
Furthermore, based upon the amount of capital we are required to raise by
the
end of the third 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. These matters
raise substantial doubt about the ability of the Company to continue as a
going
concern.
On
March
14, 2008, the Company received gross proceeds of $765,000 from the sale of
Series A Mandatorily Redeemable Convertible Preferred Stock (“Series A
Preferred”). See Note 4. The Company’s cash and cash equivalents at March 31,
2008 reflect the remaining cash proceeds to the Company from this
transaction.
Management
anticipates that the Company’s capital resources will be adequate to fund its
operations into the third quarter of 2008. Additional financing or potential
sublicensing of our rights to our product(s) will be required during the
third
quarter of 2008 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.
(D)
Stock-Based Compensation
The
Company issued options and warrants to purchase an aggregate of 885,000 shares
of its common stock during the three months ended March 31, 2008, comprised
of
120,000 shares subject to stock options to employees and 765,000 shares subject
to warrants issued to investors and placement agents.
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 15,000
shares of common stock granted to a non-employee director in the first quarter
of 2006, of which 7,500 vested immediately and 7,500 vested on the first
anniversary of the grant date, stock options to purchase 40,000 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
501,334 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
85,644
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 March 31, 2008, 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.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2008 (UNAUDITED)
Stock
options and warrants granted to parties other than employees and non-employee
directors vest over individually agreed upon terms. The Company issued 765,000
warrants that vested immediately to investors and the placement agent that
participated in the March 14, 2008 financing relating to the issuance and
sale
of Series A Preferred stock. See Note 4.
Following
the vesting periods, options are exercisable until the earlier of 90 days
after
an employee’s employment with the Company terminates or the tenth anniversary of
the initial grant, subject to adjustment under certain conditions. The Company
recorded total compensation charges in the three months ended March 31, 2008
related to the fair value of employee and non-employee director stock option
grants of $152,599.
The
Company uses the Black-Scholes option pricing model to calculate the fair
value
of options and warrants granted under Statement of Financial Accounting
Standards (“SFAS”) No. 123R, Share-based Payment (“SFAS 123R”). The key
assumptions for this valuation method include the expected term of the option,
stock price volatility, risk-free interest rate, dividend yield, exercise
price
and forfeiture rate. Many of these assumptions are judgmental and highly
sensitive in the determination of compensation expense. Under the assumptions
set forth below, the weighted average fair values of the stock options granted
during the three months ended March 31, 2008 were $0.12.
The
table
below sets forth the key assumptions used in the valuation calculations for
options granted in the three months ended March 31, 2008 and 2007:
|
|
Three
Months Ended
March
31,
|
|
|
|
2008
|
|
2007
|
|
Term
|
|
|
7
years
|
|
|
7
years
|
|
Volatility
|
|
|
298
|
%
|
|
232-233
|
%
|
Dividend
yield
|
|
|
0.0
|
%
|
|
0.0
|
%
|
Risk-free
interest rate
|
|
|
3.3
|
%
|
|
4.5-4.9
|
%
|
Forfeiture
rate
|
|
|
0%-26
|
%
|
|
22
|
%
|
The
following table summarizes information about the Company’s stock options as of
and for the three months ended March 31, 2008:
|
|
Number of
Shares
|
|
Weighted
Average
Exercise Price
|
|
Weighted Average
Remaining Contractual
Life (Years)
|
|
Aggregate
Intrinsic Value
|
|
Balance,
January 1, 2008
|
|
|
1,013,339
|
|
$
|
9.90
|
|
|
|
|
|
|
|
Granted
|
|
|
120,000
|
|
$
|
1.20
|
|
|
|
|
|
|
|
Exercised
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
Forfeited
or expired
|
|
|
(18,600
|
)
|
$
|
6.00
|
|
|
|
|
|
|
|
Outstanding
at March 31, 2008
|
|
|
1,114,739
|
|
$
|
4.60
|
|
|
7.75
|
|
$
|
-
|
|
Exercisable
at March 31, 2008
|
|
|
311,261
|
|
$
|
8.50
|
|
|
3.00
|
|
$
|
-
|
|
As
of
March 31, 2008, there was $2,026,372 of unrecognized compensation costs related
to stock options. These costs are expected to be recognized over a weighted
average period of approximately 3.28 years.
As
of
March 31, 2008, an aggregate of 235,261 shares remained available for future
grants and awards under the Company’s stock incentive plan, which covers stock
options and restricted stock awards. The Company issues unissued shares to
satisfy stock option exercises and restricted stock awards.
(E)
Warrants Issued With Convertible Debt and Mandatorily Redeemable Convertible
Preferred Stock
The
Company accounts for the value of warrants and the intrinsic value of beneficial
conversion rights arising from the issuance of convertible debt instruments
and
mandatorily redeemable convertible preferred stock with nondetachable conversion
rights that are in-the-money at the commitment date pursuant to the consensuses
for EITF Issue No. 98-5, EITF Issue No. 00-19 and EITF Issue No. 00-27. Such
values are determined by allocating an appropriate portion of the proceeds
received from the debt instruments to the debt and warrants based on their
relative fair value and an appropriate portion of the proceeds received from
the
preferred stock to the preferred stock and warrants based on their relative
fair
value.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2008 (UNAUDITED)
The
fair
value allocated to the warrants issued with convertible debt is recorded
as
additional paid-in capital and as debt discount, which is charged to interest
expense over the term of the debt instrument. The fair value allocated to
the
warrants issued with mandatorily redeemable convertible preferred stock is
recorded as additional paid-in capital and as preferred stock discount, which
is
accreted through a charge to accumulated deficit through the date of earliest
conversion.
The
intrinsic value of the beneficial conversion rights at the commitment date
may
also be recorded as additional paid-in capital and debt or preferred stock
discount as of that date or, if the terms of the debt instrument or preferred
stock are contingently adjustable, may only be recorded if a triggering event
occurs and the contingency is resolved.
(F)
Net Loss Per Common Share
Basic
net
loss per common share is calculated by dividing net loss by the weighted-average
number of common shares outstanding for the period, excluding 556,686 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 applicable
to common shareholders during each period presented. The amount of potentially
dilutive securities including options and warrants in the aggregate excluded
from the calculation were 4,451,372 (including the
556,686
common
shares held in escrow, 2,779,947 warrants, and 1,114,739 stock options) at
March
31, 2008 and 3,130,459 at December 31, 2007.
(G)
Restatement of Net Loss Per Common Share
As
a
result of the Company effecting a 1-for-10 reverse stock split on April 25,
2008, all common shares, warrants and options have been restated as of December
31, 2007. In accordance with the reverse stock split, each share of the
Company’s common stock, warrants and options, were reissued and repriced to
purchase or receive one-tenth times the number of shares of common stock
immediately theretofor purchasable and the purchase price per is 1,000 percent
of the purchase price per share.
NOTE
2
DISCONTINUED
OPERATIONS
As
explained in Note 1, the Company determined that it would dispose of Chiral
Quest on September 29, 2006 and accordingly, the operations and assets of
Chrial
Quest have been presented in these 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. As a result
of
this transaction, the Company reported a gain of $438,444 in the third quarter
of 2007. 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 three months ended March 31,
2008
and 2007 were $0 and $803,784, respectively. Loss from discontinued operations
for the three months ended March 31, 2008 and 2007, 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 $0 and $261,475, respectively.
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 $56,000 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 March 31, 2008, CQAC has fully
complied with the sublease agreement with the Company.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2008 (UNAUDITED)
NOTE
3
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 could have elected, at any time during the term, 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 had not
elected to convert the Bridge Notes, all unpaid principal plus any accrued
interest would have automatically converted 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 were not converted
into shares of the Company’s common stock, all unpaid principal plus any accrued
interest would 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 $245,450 and $50,750
(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 243,000 (195,000 and 48,000 for the
June
29, 2007 and July 3, 2007 closings, respectively) shares of the Company’s common
stock at an exercise price of $4.00 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 BCF’s 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 will also
be
amortized to interest expense over the term of the Bridge Notes.
In
connection with the Bridge Notes, the Company issued five-year warrants to
placement agents to purchase an aggregate of 120,250 shares of common stock,
which are exercisable at a price of $4.20 per share. Based on the Black-Scholes
option pricing model, the warrants had a fair value of $356,425 for the June
29,
2007 closing and $73,441 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 Company engaged
Paramount BioCapital, Inc. (“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, the Company’s
chairman, 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 45,000 shares of common stock and paid
commissions of approximately $119,700. The fair value of the warrants,
commissions and fees totaling $591,146 for the June 29, 2007 closing and
$124,016 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.
As
a
condition to the March 14, 2008 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 Mandatorily Redeemable
Convertible Preferred Stock (“Series B Preferred”). See Note 4 for further
discussion. The conversion of the Bridge Notes to Series B Preferred stock
resulted in a loss on the early extinguishment of debt of $814,355, which
is
included in interest expense for the three months ended March 31, 2008. The
loss
is related to non-cash items, such as write-off of unamortized debt issuance
costs, BCF and deferred financing costs.
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
|
%
|
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2008 (UNAUDITED)
NOTE
4
MANDATORILY
REDEEMABLE CONVERTIBLE PREFERRED STOCK
On
March
14, 2008, the Company issued 765 shares of Series A Preferred stock at a
price
of $1,000 per share together with five-year warrants to purchase an aggregate
of
approximately 637,500 shares of our common stock at an exercise price of
$1.00
per share for an aggregate purchase price of $765,000. The Company received
approximately $671,000 in net cash proceeds after closing costs.
Each
share of Series A Preferred stock sold is convertible into shares of the
Company's common stock at $0.60 per share, or approximately 1,275,000 shares
of
common stock in the aggregate. A holder of Series A Preferred stock may convert
the shares of Series A Preferred stock to common stock at any time and from
time
to time upon the holder’s election. The Series A Preferred stock shall
automatically convert into common stock in the event that the closing price
of
the common stock is equal to at least $3.80 per share (as adjusted for stock
splits, combinations and similar events) for 20 consecutive trading days.
In the
event that there has not been a voluntary conversion or mandatory conversion
of
the Series A Preferred stock by July 3, 2009, the holders of Series A Preferred
stock shall have a right to require the Company to redeem their Series A
Preferred stock out of funds lawfully available.
In
the
event of a liquidation, bankruptcy, dissolution or similar proceeding, the
holders of the Series A Preferred stock shall rank pari passu with the Series
B
Preferred stock and shall receive an amount equal to 100% of the Series A
Preferred stock price plus any accrued but unpaid dividends. The Series A
Preferred stock will be protected against dilution if the Company effects
a
subdivision or combination of its outstanding common stock or in the event
of a
reclassification, stock dividend or other distribution payable in securities
of
the Company and shall have full-ratchet antidilution protection, subject
to
standard exceptions. The holders of Series A Preferred stock will vote together
with all other holders of the Company’s voting stock on all matters submitted to
a vote of holders generally, with the holder of each share of Series A Preferred
stock being entitled to one vote for each share of common stock into which
such
shares of Series A Preferred stock could then be converted.
Based
upon the Black-Scholes option pricing model, the investor warrants are estimated
to be valued at approximately $701,000. The Company allocated the consideration
received from the sale of the Series A Preferred stock between the Series
A
Preferred stock and the warrants on the basis of their relative fair values
at
the date of issuance, allocating approximately $366,000 to the warrants.
The
value of the warrants was recognized as an increase in additional paid-in
capital and as a discount to the Series A Preferred stock. Furthermore, the
fair
value of the common shares into which the Series A Preferred stock is
convertible on the date of issuance exceeded the proceeds allocated to the
Series A Preferred stock, resulting in a beneficial conversion feature of
approximately $165,000 that was recognized as an increase in additional paid-in
capital and as a discount to the Series A Preferred stock. The discounts
are
being accreted to the redemption value of the Series A Preferred stock over
the
mandatory redemption period, using the effective interest method, through
a
charge to additional paid-in capital.
In
connection with the offering, the Company 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. The family investment partnership purchased 500
shares of Series A Preferred stock and received warrants to purchase 416,700
shares of common stock. Based upon the Black-Scholes option pricing model,
the
family investment partnership’s investor warrants are estimated to be valued at
approximately $458,000. In consideration for the placement agent’s services, the
Company paid an aggregate of approximately $54,000 in commissions to Paramount
in connection with the offering. The Company also paid to Paramount $35,000
as a
non-accountable expense allowance. In addition, the Company issued to Paramount
five-year warrants to purchase an aggregate of approximately 127,500 shares
of
common stock, which are exercisable at a price of $0.80 per share. Based
upon
the Black-Scholes option pricing model, the warrants issued to Paramount
are
estimated to be valued at approximately $140,000. The fair value of the
warrants, commissions and fees totaling approximately $234,000 that was
recognized as a decrease to the Series A Preferred stock. The discount is
being
accreted to Series A Preferred stock over the mandatory redemption period,
using
the effective interest method, through a charge to additional paid-in capital.
For the three months ended March 31, 2008, the Company accreted $6,321 of
Series
A Preferred stock discount.
The
Series A 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.
During the three months ended March 31, 2008, the Company accrued $1,913
associated with this dividend obligation, which was recorded as interest
expense
on the accompanying condensed consolidated statements of
operations.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2008 (UNAUDITED)
As
a
condition to the March 14, 2008 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 Series B Preferred stock. The Series B Preferred
stock contains substantially the same economic terms as the previously
outstanding senior convertible notes. A holder of Series B Preferred stock
may
convert the shares of Series B Preferred stock to common stock at any time
and
from time to time upon the holder’s election. The Series B Preferred stock shall
automatically convert into common stock in the event that the closing price
of
the common stock is equal to at least $3.80 per share (as adjusted for stock
splits, combinations and similar events) for 20 consecutive trading days.
The
Series B Preferred stock is subject to mandatory redemption on July 3,
2009.
Each
share of Series B Preferred stock sold is convertible into shares of the
Company's common stock at $3.80 per share, or approximately 1,029,000 shares
of
common stock in the aggregate. The Series B Preferred stock shall be entitled
to
an annual dividend equal to 8% 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. During the three months ended March
31,
2008, the Company accrued $13,034 associated with this dividend obligation,
which was recorded as interest expense on the accompanying condensed
consolidated statements of operations.
In
the
event of a liquidation, bankruptcy, dissolution or similar proceeding, the
holders of the Series B Preferred stock shall rank pari passu with the Series
A
Preferred stock and shall receive an amount equal to 100% of the Series B
Preferred stock price plus any accrued but unpaid dividends.
The
following assumptions were used for the Black-Scholes calculations for the
warrants related to the financing:
Term
|
|
|
5
years
|
|
Volatility
|
|
|
301
|
%
|
Dividend
yield
|
|
|
0.0
|
%
|
Risk-free
interest rate
|
|
|
2.4
|
%
|
NOTE
5
SUBSEQUENT
EVENTS
On
April
15, 2008, the Company’s Board of Directors authorized an amendment to the
Company’s certificate of incorporation to provide for the combination of the
Company’s common stock in the form of a 1-for-10 reverse stock split. In
accordance with the reverse stock split, each share of the Company’s common
stock was reissued and repriced for each 10 shares of common stock exchanged
by
the holders of record at 12:01 a.m. on April 25, 2008 (the “Effective Time”).
Further, each option to purchase shares of common stock outstanding as of
the
Effective Time and any other outstanding and unexercised warrants or similar
rights to purchase or receive shares of common stock outstanding immediately
prior to the Effective Time provides the right to purchase or receive one-tenth
times the number of shares of common stock immediately theretofor purchasable
and the purchase price per share shall be 1,000 percent of the purchase price
per share immediately theretofor payable. The number of shares reserved for
issuance under the Company’s 2003 Stock Option Plan shall become one-tenth the
number of shares reserved for issuance as of the Effective Time.
On
April
14, 2008, the Company appointed Vernon L. Alvarez, Ph.D., as Vice President
of
Research and Development.
On
April
11, 2008, Edward C. Bradley, M.D., the Company’s Chief Scientific Officer,
resigned from his part-time position with the Company. In consideration of
Dr.
Bradley’s service, the Company accelerated the vesting of Dr. Bradley’s stock
options to purchase an additional 23,333 shares of the Company’s common stock.
Furthermore, the exercise period for his vested options is extended until
December 31, 2008. Incremental compensation cost is incurred when the terms
of
his award are modified. Based upon the Black-Scholes option pricing model,
the
incremental cost is approximately $15,000, which is measured by comparing
the
fair value of the modified award with the fair value of the award immediately
before the modification.
On
April
9, 2008, the Company issued 2,194.5 shares of Series A Preferred stock at
a
price of $1,000 per share together with five-year warrants to purchase an
aggregate of approximately 1.83 million shares of our common stock at an
exercise price of $1.00 per share for an aggregate purchase price of $2,195,000.
The Company received approximately $2,041,000 in net cash proceeds after
closing
costs. In addition, the Company reissued the 765 shares of Series A Preferred
stock originally sold on March 14, 2008, on the same terms as if the shares
had
been purchased on April 9, 2008.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH
31, 2008 (UNAUDITED)
Each
share of Series A Preferred stock sold is convertible into shares of the
Company's common stock at $0.60 per share, or approximately 3.66 million
shares
of common stock in the aggregate. A holder of Series A Preferred stock may
convert the shares of Series A Preferred stock to common stock at any time
and
from time to time upon the holder’s election. The Series A Preferred stock shall
automatically convert into common stock in the event that the closing price
of
the common stock is equal to at least $3.80 per share (as adjusted for stock
splits, combinations and similar events) for 20 consecutive trading days.
The
Series A Preferred stock is subject to mandatory redemption on July 3, 2009.
As
of
April 1, 2008, the Series B Preferred stockholders are foreclosed from
exercising their Series B Preferred stock participation rights and may not
convert any of their Series B Preferred stock into the securities. A “Series B
Participation Right” means the right of the Series B Preferred stockholder to
convert all or any portion of such Series B Preferred stockholder’s shares of
Series B Preferred stock into the securities, as follows: for each $1.00
of new
money invested in the April 9, 2008 offering by the Series B Preferred
stockholder, such Series B Preferred stockholder shall be entitled to convert
$1.00 of Series B Preferred stock into the securities at a price equal to
the
April 9, 2008 offering price.
Certain
Series B Preferred stockholders exercised their right to convert Series B
Preferred stock into Series A Preferred stock by investing new money in the
April 9, 2008 offering. These holders invested $505,000 of new money in the
April 9, 2008 offering and earned the right to convert $505,000 of Series
B
Preferred stock, convertible into shares of the Company’s common stock at $3.80
per share, into Series A Preferred stock, convertible into shares of the
Company’s common stock at $0.60 per share. As such, the Company will record a
charge for the induced conversion of Series B Preferred stock of approximately
$709,000, which will be included in net loss applicable to common shareholders.
The converting stockholders received 505 shares of Series A Preferred
Stock.
In
connection with the offering, the Company engaged Paramount as our placement
agent. In consideration for the placement agent’s services, the Company paid an
aggregate of approximately $153,000 in commissions to Paramount in connection
with the offering. In addition, the Company issued to Paramount five-year
warrants to purchase an aggregate of approximately 365,800 shares of common
stock, which are exercisable at a price of $0.80 per share. Based upon the
Black-Scholes option pricing model, the warrants issued to Paramount are
estimated to be valued at approximately $366,000. The Series A 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.
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
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
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.
VIOQUEST
PHARMACEUTICALS, INC. AND SUBSIDIARIES
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
|
|
$
|
694,556
|
|
$
|
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
NOTE
5
PROPERTY
AND EQUIPMENT OF CONTINUING OPERATIONS, NET
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
|
|
|
Weighted
Average Remaining
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.
1,307,581 Shares
Common
Stock
VioQuest
Pharmaceuticals, Inc.
______________________,
2008
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
13. Other Expenses of Issuance and Distributions
The
registrant estimates that expenses payable by the registrant is connection
with
the offering described in this registration statement will be as follows:
SEC
registration fee
|
|
$
|
247.19
|
|
Legal
fees and expenses
|
|
$
|
|
|
Accounting
fees and expenses
|
|
$
|
|
|
Printing
and engraving expenses
|
|
$
|
|
|
Miscellaneous
|
|
$
|
|
|
|
|
|
|
|
Total
|
|
$
|
|
|
Item
14.
Indemnification
of Directors and Officers.
Section 145
of the General Corporation Law of the State of Delaware provides as follows:
A
corporation may indemnify any person who was or is a party or is threatened
to
be made a party to any threatened, pending or completed action, suit or
proceeding, whether civil, criminal, administrative or investigative (other
than
an action by or in the right of the corporation) by reason of the fact that
the
person is or was a director, officer, employee or agent of the corporation,
or
is or was serving at the request of the corporation as a director, officer,
employee or agent or another corporation, partnership, joint venture, trust
or
other enterprise, against expenses (including attorneys’ fees), judgments, fines
and amounts paid in settlement actually and reasonably incurred by the person
in
connection with such action, suit or proceeding if the person acted in good
faith and in a manner the person reasonably believed to be in or not opposed
to
the best interest of the corporation, and, with respect to any criminal action
or proceeding, had no reasonable cause to believe the person’s conduct was
unlawful. The termination of any action, suit or proceeding by judgment, order,
settlement, conviction or upon a plea of nolo contendere or its equivalent,
shall not, of itself, create a presumption that the person did not act in good
faith and in a manner which he reasonably believed to be in or not opposed
to
the best interests of the corporation, and, with respect to any criminal action
or proceeding, had reasonable cause to believe that the person’s conduct was
unlawful.
A
corporation may indemnify any person who was or is a party or is threatened
to
be made a party to any threatened, pending or completed action or suit by or
in
the right of the corporation to procure a judgment in its favor by reason of
the
fact that he is or was a director, officer, employee or agent of the
corporation, or is or was serving at the request of the corporation as a
director, officer, employee or agent of another corporation, partnership, joint
venture, trust or other enterprise against expenses (including attorneys’ fees)
actually and reasonably incurred by the person in connection with the defense
or
settlement of such action or suit if the person acted in good faith and in
a
manner the person reasonably believed to be in or not opposed to the best
interests of the corporation and except that no indemnification will be made
in
respect to any claim, issue or matter as to which such person shall have been
adjudged to be liable to the corporation unless and only to the extent that
the
Court of Chancery or the court in which such action or suit was brought shall
determine upon application that, despite the adjudication of liability but
in
view of all the circumstances of the case, such person is fairly and reasonably
entitled to indemnity for such expenses which the Court of Chancery or such
other court shall deem proper.
Our
certificate of incorporation provides that we will indemnify any person,
including persons who are not our directors and officers, to the fullest extent
permitted by Section 145 of the Delaware General Corporation Law.
In
addition, pursuant to our bylaws, we will indemnify our directors and officers
against expenses (including judgments or amounts paid in settlement) incurred
in
any action, civil or criminal, to which any such person is a party by reason
of
any alleged act or failure to act in his capacity as such, except as to a matter
as to which such director or officer shall have been finally adjudged to be
liable for negligence or misconduct in the performance of his duty to the
corporation or not to have acted in good faith in the reasonable belief that
his
action was in the best interest of the corporation.
Reference
is made to Item 17 for our undertakings with respect to indemnification for
liabilities arising under the Securities Act of 1933.
Item
15.
Recent Sales of Unregistered Securities.
Private
Placement of Preferred Stock in March and April 2008
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.
On
April 9, 2008, we issued 2,194.5 shares of Series A Convertible Preferred Stock
at a price of $1,000 per share resulting in aggregate gross proceeds of
$2,194,500, and reissued the shares originally issued on March 14, 2008, for
total gross proceeds of $2,959,500. Each share of Series A Convertible Preferred
Stock sold is convertible into shares of our common stock at $0.60 per share,
or
approximately 4.93 million shares of common stock in the aggregate. In addition,
two investors elected to convert a portion of the principal and unpaid but
accrued interest of their note into 505 shares of Series A Convertible Preferred
Stock on the same terms as their purchase of Series A Convertible Preferred
Stock. We also issued to investors five-year warrants to purchase an aggregate
of approximately 2.88 million shares of our common stock at an exercise price
of
$1.00 per share. 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 holder of our stock. 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 $207,000 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 492,416 shares
of common stock, which are exercisable at a price of $0.80 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 our option. If we choose 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
3,410 shares of our newly-designated Series B Convertible Preferred Stock.
The
Series A Preferred Stock was sold to 35 investors, each of which we reasonably
believed was an “accredited investor,” as defined under Rule 501(a) of the
Securities Act of 1933, and no means of general solicitation or advertising
was
used in connection with the offering. Accordingly, we relied on the exemptions
from the registration requirements of the Securities Act provided by Section
4(2) and Rule 506.
Private
Placement
of
Convertible Promissory Notes in June and July 2007
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, as adjusted for the 1-for-10 reverse
stock split, an aggregate of approximately 243,000 shares of our common stock
at
an exercise price of $4.00 per share. In connection with the offering, we
engaged Paramount as one of our placements agents. 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, as adjusted for the 1-for-10 reverse
stock split, an aggregate of approximately 120,000 shares of common stock,
of
which 45,000 shares of common stock were issued to Paramount, which are
exercisable at a price of $4.20 per share. The convertible promissory notes
were
sold to 40 investors, each of which we reasonably believed was an “accredited
investor,” as defined under Rule 501(a) of the Securities Act of 1933, and no
means of general solicitation or advertising was used in connection with the
offering. Accordingly, we relied on the exemptions from the registration
requirements of the Securities Act provided by Section 4(2) and Rule 506. As
a
condition to the initial closing of the private placement of our Series A
Convertible Preferred Stock, a majority of the principal amount outstanding
under these notes agreed to convert all principal, together with accrued
interest, into approximately 3,405 shares of our newly-designated Series B
Convertible Preferred Stock. Each share of Series B Convertible Preferred Stock
is convertible into shares of our common stock at $3.80 per share, or
approximately 896,096 shares of common stock in the aggregate as adjusted for
the 1-for-10 reverse stock split.
October
2006 Private Placement
On
October 18, 2006, we sold 789,160 shares of our common stock at a price of
$5.00
per share, as adjusted for our 1-for-10 reverse stock split, resulting in gross
proceeds of approximately $3.95 million. In addition to the shares of common
stock, the investors also received 5-year warrants to purchase an aggregate
of
276,206 shares at an exercise price of $7.30 per share, as adjusted for our
1-for-10 reverse stock split. We engaged Paramount BioCapital, Inc. as our
exclusive placement agent in connection with the offering, and Paramount
BioCapital 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. We also
issued to the placement agents 5-year warrants to purchase an aggregate of
39,458 shares of common stock at a price of $5.50 per share, as adjusted for
our
1-for-10 reverse stock split. The common shares and warrants were sold to
seventy-one investors, each of which we reasonably believed was an “accredited
investor,” as defined under Rule 501(a) of the Securities Act of 1933, and no
means of general solicitation or advertising was used in connection with the
offering. Accordingly, we relied on the exemptions from the registration
requirements of the Securities Act provided by Section 4(2) and Rule
506.
Issuance
in connection with the Acquisition of Greenwich Therapeutics,
Inc.
In
connection with our merger of our wholly-owned subsidiary VQ Acquisition Corp.,
with Greenwich Therapeutics, Inc. (“Greenwich”), effective as of October 18,
2005, it issued an aggregate of 1,712,879 shares of our common stock and
five-year warrants to purchase 400,000 shares at an exercise price of $14.10,
as
adjusted for our 1-for-10 reverse stock split, to the former stockholders of
Greenwich in exchange for their shares of Greenwich common stock. We relied
on
the exemption from federal registration under Section 4(2) of the Securities
Act, based on our belief that the issuance of such securities did not involve
a
public offering, as there were fewer than 35 “non-accredited” investors, all of
whom, either alone or through a purchaser representative, had such knowledge
and
experience in financial and business matters so that each was capable of
evaluating the risks of the investment.
As
a
result of the merger, we assumed Greenwich’s outstanding indebtedness of
approximately $794,000, which resulted from a promissory note issued to
Paramount BioCapital Investments, LLC. The note was amended at the time of
the
merger to provide that we would assume the outstanding indebtedness under the
note. We have now satisfied $295,000 of the indebtedness due under the amendment
by issuing 392,830 shares of our pre-reverse split common stock at a pre-reverse
split per-share price of $7.50 to Paramount.
October
2005 Private Placement
On
October 18, 2005, we sold in a private placement offering to accredited
investors units of our securities consisting of shares of common stock
a
nd
warrants to purchase additional shares of common stock. We sold an aggregate
of
1,117,997 shares of five-year warrants to purchase 447,197 shares at an exercise
price of $10.00 per share, as adjusted for our 1-for-10 reverse stock split.
The
total gross proceeds resulting from this offering were approximately $8.4
million, before deducting selling commissions and expenses. We paid total cash
commissions of approximately $587,000 to selling agents engaged in connection
with the offering and issued 5-year warrants to purchase an aggregate of 111,799
shares of common stock, exercisable at a price of $10.00 per share, as adjusted
for our 1-for-10 reverse stock split. In connection with this offering, we
relied on the exemption from federal registration under Section 4(2) of the
Securities Act and/or Rule 506 promulgated thereunder, based on our belief
that
the offer and sale of the shares and warrants did not involve a public offering
as each investor was “accredited” and no general solicitation was involved in
the offering.
Item
16.
Exhibits
and Financial Statement Schedules.
The
following exhibits are filed as part of this registration statement:
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 (incorporated by reference to
Exhibit
3.1 to the Registrant’s Annual Report on Form 10-KSB for the year ended
December 31, 2007).
|
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).
|
4.12
|
|
Form
of warrant issued to investors By Registrant on April 9, 2008(incorporated
by reference to Exhibit 4.1 to Registrant's 10-Q Filed on May 14,
2008).
|
4.13
|
|
Form
of First Amentment to Senior Convertible Promissory Note issued by
Registrant on June 29, 2007 and July 3, 2007 (incorporated by reference
to
Registrant's 10-Q filed on May 14, 2008).
|
5.1
|
|
Opinion
of Maslon Edelman Borman & Brand, LLP (previously
filed).
|
10.1
|
|
2003
Stock Option Plan, as amended (incorporated by reference to Exhibit
10.1
to the Registrant’s Form 8-K filed on June 19, 2008).
|
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 (incorporated by reference to Exhibit 10.14 to the Registrant’s
Annual Report on Form 10-KSB for the year ended December 31,
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 (incorporated by reference to Exhibit 10.16 to
the
Registrant’s Annual Report on Form 10-KSB for the year ended December 31,
2007).
|
10.17
|
|
Form
of Subscription Agreement between Registrant and various investors
accepted on March 14, 2008 and April 9, 2008 (incorporated by reference
to
Registrant's 10-Q filed on May 14, 2008).
|
10.18
|
|
Form
of Stock Option Agreement dated June 13, 2008 between VioQuest
Pharmaceuticals, Inc. and Michael Becker (incorporated by reference
to
Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed on June
19, 2008).
|
10.19
|
|
Form
of Stock Option Agreement dated June 13, 2008 between VioQuest
Pharmaceuticals, Inc. and Brian Lenz (incorporated by reference to
Exhibit
10.3 of the Registrant’s Current Report on Form 8-K filed on June 19,
2008).
|
10.20
|
|
Form
of Director Stock Option Agreement dated June 13, 2008 (incorporated
by
reference to Exhibit 10.4 of the Registrant’s Current Report on Form 8-K
filed on June 19, 2008).
|
10.21
|
|
Form
of Amendment to Stock Option Agreement dated June 13, 2008 (incorporated
by reference to Exhibit 10.5 of the Registrant’s Current Report on Form
8-K filed on June 19, 2008).
|
10.22
|
|
Amendment
dated June 13, 2008 to Stock Option Agreement dated November 21,
2007
between VioQuest Pharmaceuticals, Inc. and Michael Becker for 501,334
shares (incorporated by reference to Exhibit 10.7 of the Registrant’s
Current Report on Form 8-K filed on June 19, 2008)..
|
21.1
|
|
Subsidiaries
of the Registrant (incorporated by reference to Exhibit 21.1 to the
Registrant’s Annual Report on Form 10-KSB for the year ended December 31,
2007).
|
23.1
|
|
Consent
of J.H. Cohn LLP.
|
23.2
|
|
Consent
of Maslon Edelman Borman & Brand, LLP (previously
filed).
|
24.1
|
|
Power
of Attorney (previously filed).
|
_____________________
++
Confidential treatment has been granted as to certain portions of this exhibit
pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
Item
17.
Undertakings.
(a)
That,
for purposes of determining liability under the Securities Act to any purchaser:
insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers and controlling persons of the
registrant pursuant to the foregoing provisions or otherwise, the registrant
has
been advised that in the opinion of the SEC such indemnification is against
public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the registrant of expenses incurred
or
paid by a director, officer or controlling person of the registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Securities Act and will be governed by the final
adjudication of such issue.
Each
prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying on Rule
430B
or other than prospectuses filed in reliance on Rule 430A, shall be deemed
to be
part of and included in the registration statement as of the date it is first
used after effectiveness. Provided, however, that no statement made in a
registration statement or prospectus that is part of the registration statement
or made in a document incorporated or deemed incorporated by reference into
the
registration statement or prospectus that is part of the registration statement
will, as to a purchaser with a time of contract of sale prior to such first
use,
supersede or modify any statement that was made in the registration statement
or
prospectus that was part of the registration statement or made in any such
document immediately prior to such date of first use.
(b)
The
registrant hereby undertakes:
(1)
to
file, during any period in which offers or sales are being made, a
post-effective amendment to this registration statement: (i) to include any
prospectus required by Section 10(a)(3) of the Securities Act; (ii) to reflect
in the prospectus any facts or events arising after the effective date of the
registration statement (or the most recent post-effective amendment thereof)
which, individually or in the aggregate, represent a fundamental change in
the
information set forth in the registration statement; and (iii) to include any
additional or changed material information on the plan of
distribution;
(2)
that,
for the purpose of determining any liability under the Securities Act, each
such
post-effective amendment shall be deemed to be a new registration statement
relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof;
and
(3)
to
remove from registration by means of a post-effective amendment any of the
securities being registered which remain unsold at the termination of the
offering.
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant has duly
caused this registration statement to be signed on its behalf by the
undersigned, thereunto duly authorized, in the City of Basking Ridge, New
Jersey, on August 5, 2008.
VIOQUEST
PHARMACEUTICALS, INC.
|
|
|
By:
|
/s/
Michael
D. Becker
|
|
Michael
D. Becker
|
|
Chief
Executive Officer and
President
|
POWER
OF ATTORNEY
Pursuant
to the requirements of the Securities Act of 1933, this registration statement
has been signed as of August 5, 2008, by the following persons in the capacities
indicated.
Name
|
|
Title
|
|
|
|
/s/
Michael D. Becker
|
|
President,
Chief Executive Officer and Director (Principal
|
Michael
D. Becker
|
|
Executive
Officer)
|
|
|
|
/s/
Christopher P. Schnittker
|
|
Chief Financial Officer (Principal Financial and Accounting
|
Christopher
P. Schnittker
|
|
Officer)
|
|
|
|
|
|
Chairman
of the Board and Secretary
|
Stephen
C. Rocamboli
|
|
|
|
|
|
|
|
Director
|
Johnson
Y.N. Lau
|
|
|
|
|
|
|
|
Director
|
Michael
Weiser
|
|
|
*
Signed
by Michael D. Becker as Attorney-in-Fact, pursuant to Power of Attorney granted
on May 22, 2008.
INDEX
TO EXHIBITS FILED WITH THIS REGISTRATION STATEMENT
Exhibit
No.
|
Description
|
5.1
|
Consent
of Maslon Edelman Borman & Brand, LLP (previously
filed.)
|
23.1
|
Consent
of J.H. Cohn LLP
|
23.2
|
Consent
of Maslon Edelman Borman & Brand, LLP (previously
filed).
|
24.1
|
Power
of Attorney (previously filed).
|