Delaware
|
58-1486040
|
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification No.)
|
Page
|
||
PART
I
|
FINANCIAL
INFORMATION
|
|
Item
1.
|
Unaudited
Condensed Consolidated Financial Statements
|
1
|
Item
2.
|
Management’s
Discussion and Analysis or
Plan of Operations
|
11 |
Item
3A(T).
|
Controls
and Procedures
|
16
|
PART
II
|
OTHER
INFORMATION
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
17
|
Item
5.
|
Other
Information
|
17
|
Item
6.
|
Exhibits
|
19
|
Signatures
|
19
|
|
Index
To Exhibits Filed With This Report
|
20
|
·
|
the
possibility that the results of clinical trials will not be successful;
|
·
|
the
possibility that our development efforts relating to our product
candidates, including Lenocta™, VQD-002 and Xyfid™, will not be
successful;
|
·
|
the
inability to obtain regulatory approval of our product
candidates;
|
·
|
our
reliance on third-parties to develop our product
candidates;
|
·
|
our
lack of experience in developing and commercializing pharmaceutical
products;
|
·
|
the
possibility that our licenses to develop and commercialize our product
candidates may be terminated;
|
·
|
our
ability to obtain additional financing;
|
·
|
our
ability to protect our proprietary
technology.
|
September 30, 2007
(Unaudited)
|
December 31, 2006
(Note 1A)
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
and cash equivalents
|
$
|
2,456,639
|
$
|
2,931,265
|
|||
Prepaid
clinical research costs
|
299,960
|
273,172
|
|||||
Deferred
financing costs
|
536,371
|
-
|
|||||
Other
current assets
|
111,011
|
168,841
|
|||||
Current
assets associated with discontinued operations
|
-
|
2,396,435
|
|||||
Total
Current Assets
|
3,403,981
|
5,769,713
|
|||||
PROPERTY
AND EQUIPMENT, NET
|
37,466
|
43,378
|
|||||
SECURITY
DEPOSITS
|
15,232
|
15,232
|
|||||
TOTAL
ASSETS
|
$
|
3,456,679
|
$
|
5,828,323
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY (DEFICIENCY)
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
2,032,514
|
$
|
1,031,458
|
|||
Accrued
compensation and related taxes
|
299,434
|
245,475
|
|||||
Other
accrued expenses
|
708,462
|
180,440
|
|||||
Note
payable - Paramount BioSciences, LLC
|
-
|
264,623
|
|||||
Convertible
notes, net of unamortized debt discount of $1,223,451
|
2,550,549
|
-
|
|||||
Current
liabilities associated with discontinued operations
|
-
|
1,265,568
|
|||||
TOTAL
LIABILITIES
|
5,590,959
|
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 at September 30, 2007 and December 31, 2006
|
-
|
-
|
|||||
Common
stock; $0.001 par value: 100,000,000 shares authorized at September
30,
2007 and December 31, 2006, 54,621,119 shares issued and outstanding
at
September 30, 2007 and December 31, 2006
|
54,621
|
54,621
|
|||||
Additional
paid-in capital
|
34,223,939
|
31,326,694
|
|||||
Accumulated
deficit
|
(36,412,840
|
)
|
(28,540,556
|
)
|
|||
Total
Stockholders' Equity (Deficiency)
|
(2,134,280
|
)
|
2,840,759
|
||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY)
|
$
|
3,456,679
|
$
|
5,828,323
|
For the Three
Months Ended
September 30,
2007
|
For the Three
Months Ended
September 30,
2006
|
For the Nine
Months Ended
September 30,
2007
|
For the Nine
Months Ended
September 30,
2006
|
||||||||||
OPERATING
EXPENSES
|
|||||||||||||
Research
and development
|
$
|
1,473,937
|
$
|
273,876
|
$
|
3,793,592
|
$
|
933,599
|
|||||
Selling,
general and administrative
|
1,199,182
|
673,495
|
3,305,232
|
2,348,030
|
|||||||||
Total
Operating Expenses
|
2,673,119
|
947,371
|
7,098,824
|
3,281,629
|
|||||||||
LOSS
FROM OPERATIONS
|
(2,673,119
|
)
|
(947,371
|
)
|
(7,098,824
|
)
|
(3,281,629
|
)
|
|||||
INTEREST
(EXPENSE) / INCOME, NET
|
(542,360
|
)
|
36,246
|
(510,285
|
)
|
85,361
|
|||||||
LOSS
FROM CONTINUING OPERATIONS
|
(3,215,479
|
)
|
(911,125
|
)
|
(7,609,109
|
)
|
(3,196,268
|
)
|
|||||
DISCONTINUED
OPERATIONS
|
|||||||||||||
Loss
from discontinued operations
|
(104,722
|
)
|
(973,892
|
)
|
(701,619
|
)
|
(2,368,847
|
)
|
|||||
Gain
on sale of business
|
438,444
|
-
|
438,444
|
-
|
|||||||||
INCOME
/ (LOSS) FROM DISCONTINUED OPERATIONS
|
333,722
|
(973,892
|
)
|
(263,175
|
)
|
(2,368,847
|
)
|
||||||
NET
LOSS
|
$
|
(2,881,757
|
)
|
$
|
(1,885,017
|
)
|
$
|
(7,872,284
|
)
|
$
|
(5,565,115
|
)
|
|
NET
INCOME (LOSS) PER COMMON SHARE:
|
|||||||||||||
CONTINUING
OPERATIONS
|
$
|
(0.07
|
)
|
$
|
(0.02
|
)
|
$
|
(0.17
|
)
|
$
|
(0.08
|
)
|
|
DISCONTINUED
OPERATIONS
|
0.01
|
(0.03
|
)
|
(0.00
|
)
|
(0.07
|
)
|
||||||
NET
LOSS PER SHARE – BASIC AND DILUTED
|
$
|
(0.06
|
)
|
$
|
(0.05
|
)
|
$
|
(0.17
|
)
|
$
|
(0.15
|
)
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING - BASIC AND DILUTED
|
46,056,724
|
38,165,124
|
46,056,724
|
38,165,124
|
Total
|
||||||||||||||||
Stockholders'
|
||||||||||||||||
Common Stock
|
Additional
|
Accumulated
|
Equity
|
|||||||||||||
Shares
|
Amount
|
Paid-In Capital
|
Deficit
|
(Deficiency)
|
||||||||||||
Balance,
January 1, 2007
|
54,621,119
|
$
|
54,621
|
$ |
31,326,694
|
$ | (28,540,556
|
) | $ | 2,840,759
|
||||||
Net
loss
|
(7,872,284
|
)
|
(7,872,284
|
)
|
||||||||||||
Fair
value of beneficial conversion feature and warrants issued in conjunction
with convertible notes
|
1,963,512
|
1,963,512
|
||||||||||||||
Stock-based
compensation to employees
|
868,016
|
868,016
|
||||||||||||||
Stock-based
compensation to consultants and finder
|
65,717
|
65,717
|
||||||||||||||
Balance,
September 30, 2007
|
54,621,119
|
$
|
54,621
|
$
|
34,223,939
|
$
|
(36,412,840
|
)
|
$
|
(2,134,280
|
)
|
For the Nine
Months Ended
September 30, 2007
|
For the Nine
Months Ended
September 30, 2006
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(7,872,284
|
)
|
$
|
(5,565,115
|
)
|
|
Loss
from discontinued operations
|
263,175
|
2,368,847
|
|||||
Loss
from continuing operations
|
(7,609,109
|
)
|
(3,196,268
|
)
|
|||
Adjustments
to reconcile loss from continuing operations to net cash used in
continuing operating activities:
|
|||||||
Depreciation
|
6,499
|
3,804
|
|||||
Stock-based
compensation to employees
|
830,021
|
589,673
|
|||||
Stock-based
compensation to consultants and finder
|
62,632
|
33,119
|
|||||
Amortization
of debt discount and deferred financing fees
|
562,986
|
-
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Prepaid
clinical research costs
|
(26,788
|
)
|
(180,238
|
)
|
|||
Other
assets
|
57,830
|
(79,109
|
)
|
||||
Accounts
payable
|
1,001,056
|
336,967
|
|||||
Accrued
expenses
|
581,981
|
86,014
|
|||||
Net
Cash Used in Continuing Operating Activities
|
(4,532,892
|
)
|
(2,406,038
|
)
|
|||
Discontinued
Operating Activities:
|
|||||||
Gain
on sale of business
|
(438,444
|
)
|
-
|
||||
Cash
used in discontinued operating activities
|
(348,809
|
)
|
(2,633,511
|
)
|
|||
Net
Cash Used in Operating Activities
|
(5,320,145
|
)
|
(5,039,549
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Payments
for purchased equipment
|
(5,127
|
)
|
(14,987
|
)
|
|||
Net
Cash Used in Continuing Investing Activities
|
(5,127
|
)
|
(14,987
|
)
|
|||
Discontinued
Investing Activities:
|
|||||||
Proceeds
from sale of business
|
1,727,263
|
-
|
|||||
Other
cash used in discontinued investing activities
|
(26,698
|
)
|
(143,734
|
)
|
|||
Net
Cash Provided By / (Used in) Investing Activities
|
1,695,438
|
(158,721
|
)
|
||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Debt
activity:
|
|||||||
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
|
-
|
|||||
NET
DECREASE IN CASH AND CASH EQUIVALENTS
|
(474,626
|
)
|
(5,198,270
|
)
|
|||
CASH
AND CASH EQUIVALENTS – BEGINNING OF PERIOD
|
2,931,265
|
6,021,399
|
|||||
CASH
AND CASH EQUIVALENTS – END OF PERIOD
|
$
|
2,456,639
|
$
|
823,129
|
|||
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
|
$
|
803,823
|
$
|
-
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||
2007
|
2006
|
2007
|
2006
|
||||||||||
Term
|
7
years
|
7
years
|
7
years
|
7
years
|
|||||||||
Volatility
|
240-259
|
%
|
217
|
%
|
232-259
|
%
|
210-217
|
%
|
|||||
Dividend
yield
|
0.0
|
%
|
0.0
|
%
|
0.0
|
%
|
0.0
|
%
|
|||||
Risk-free
interest rate
|
4-5
|
%
|
5
|
%
|
4-5
|
%
|
4.4-5
|
%
|
|||||
Forfeiture
rate
|
22
|
%
|
25
|
%
|
22
|
%
|
22-25
|
%
|
Number of
Options
|
Weighted
Average
Exercise Price
|
Weighted Average
Remaining Contractual
Life (Years)
|
Aggregate
Intrinsic Value
|
||||||||||
Balance,
January 1, 2007
|
5,384,807
|
$
|
0.99
|
||||||||||
Granted
|
1,386,000
|
$
|
0.50
|
||||||||||
Exercised
|
-
|
-
|
|||||||||||
Forfeited
or expired
|
(1,229,918
|
)
|
$
|
1.20
|
|||||||||
Outstanding
at September 30, 2007
|
5,540,889
|
$
|
0.80
|
7.50
|
-
|
||||||||
Exercisable
at September 30, 2007
|
2,223,791
|
$
|
0.96
|
7.00
|
-
|
Face
value of convertible notes
|
$
|
3,700,000
|
||
Accrued
but unpaid interest
|
74,000
|
|||
|
||||
Gross
value of convertible notes
|
3,774,000
|
|||
|
||||
Debt
discount, Bridge Warrants
|
729,823
|
|||
BCF,
Bridge Warrants
|
729,823
|
|||
BCF,
convertible interest
|
74,000
|
|||
Less:
Amortization of debt discount
|
(310,195
|
)
|
||
|
||||
Unamortized
debt discount
|
$
|
1,223,451
|
||
|
||||
Convertible
notes, net of unamortized debt discount
|
2,550,549
|
Deferred
financing costs
|
$
|
715,162
|
||
Less:
Accumulated amortization
|
(178,791
|
)
|
||
|
||||
Deferred
financing costs, net
|
$
|
536,371
|
Term
|
5
years
|
|||
Volatility
|
240
|
%
|
||
Dividend
yield
|
0.0
|
%
|
||
Risk-free
interest rate
|
4.9-5.0
|
%
|
·
|
Lenocta™
(Sodium Stibogluconate).
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
U.S. military personnel serving in parts of the world where leishmaniasis
is prevalent. In collaboration with the U.S. Army, we are pursuing
development of Lenocta™ in the treatment of leishmaniasis and anticipate
filing a new drug application, or NDA, with the U.S. Food and Drug
Administration, or FDA, in the first half of 2008. In December 2006,
Lenocta™ received orphan drug designation by the FDA for the treatment of
leishmaniasis. In addition to the treatment for leishmaniasis, several
preclinical studies, especially those conducted at the Cleveland
Clinic,
have showed that Lenocta™ is an inhibitor of multiple protein tyrosine
phosphatases (PTPases), specifically the SRC homology PTPase (SHP-1
&
SHP-2) and PTB-1B. These intracellular enzymes are involved in signaling
pathways of many receptor-linked tyrosine kinases which are involved
in
growth, proliferation and differentiation of cancer cells. Inhibition
of
these enzymes with Lenocta™ can trigger apoptosis, or cell death, of
cancerous tumors. This cytotoxic effect, coupled with its potential
ability to enhance the body’s immune system, through improved cytokine
signaling and t-cell formation, suggest that Lenocta™ has potential as an
anti-cancer agent. It is well known that one major mechanism of regulating
the proliferation, growth and apoptosis of cancer cells involves
activation of cellular pathways, especially protein tyrosine kinase
pathways; the Jak/Stat pathway is a particularly important protein
tyrosine kinase pathway. It is also known that interferon and other
cytokines exert their anti-cancer effects via the Jak/Stat pathway.
We
filed with the FDA an IND for Lenocta™, which the FDA allowed in August
2006, allowing us to commence clinical trials of Lenocta™. Lenocta™ is
currently being evaluated in combination with IFN a-2b
in a 24-patient investigator-sponsored Phase I clinical trial at
the
Cleveland Clinic Taussig Cancer Center in refractory solid tumors,
lymphoma and myeloma. We are also currently evaluating the safety,
tolerability and activity of Lenocta™ in a separate, company-sponsored
study of up to a 54-patient Phase I/IIa clinical trial at M.D. Anderson
Cancer Center in patients with solid tumors. In October 2007, we
completed
patient enrollment in our Phase I clinical trials. Recently, data
was
presented from our Phase I open-label dose escalation trial where
a total
of 17 patients were enrolled at the M.D. Anderson center, which were
comprised of 4 melanoma, 3 colon, 4 pancreas, 1 neuroendocrine, 1
ovarian,
2 head and neck adenocarcinoma, 1 head and neck squamous cell and
1
mesothelioma. One patient with melanoma achieved stable disease after
two
cycles of treatment. Asymptomatic hypokalemia was the only dose limiting
toxicity (DLT) observed. In addition to reaching the maximum tolerated
dose (MTD), dose dependent activities were observed in protocol-specified
surrogate biomarkers in both cellular and humoral immunologic functions.
Further analysis of the data showed an increase in pharmacodynamic
activities as demonstrated by an increase in the activities of natural
killer, CD8 and type II dendritic cells. During the fourth quarter
of
2007, we expect to initiate Phase II clinical
trials.
|
·
|
VQD-002
(Triciribine-Phosphate). VQD-002,
a nucleoside, was previously advanced into clinical trials by the
National
Cancer Institute in the 1980s and early 1990s, and showed anti-cancer
activities. More recently, investigators at the Moffitt Cancer Center
of
the University of South Florida were able to demonstrate from preclinical
studies that VQD-002’s mechanism of action is the inhibition of Akt
phosphorylation (protein kinase - B), which is found to be over activated
and over-expressed in various malignancies including breast, ovarian,
colorectal, and pancreatic lymphoma and leukemias. Clinically, the
over
expression of phosphorylated Akt is associated with poor prognosis,
resistance to chemotherapy and shortened survival time of cancer
patients.
We filed with the FDA an IND relating to VQD-002, which was allowed
in
April 2006. Pursuant to this IND, we are currently evaluating the
safety,
tolerability and activity of VQD-002 and its ability to reduce Akt
phosphorylaion in two Phase I/IIa clinical trials, including one
at the
Moffitt Cancer Center in up to 42 patients with hyper-activated,
phosphorylated Akt in colorectal, pancreatic, breast and ovarian
tumors
and a second clinical trial, with up to 40 patients, at the M.D.
Anderson
Cancer Center in hematological tumors, with particular attention
in
leukemia. In the second half of 2007, we expect to complete patient
enrollment in our Phase I clinical trials and expect to initiate
Phase II
clinical trials. Recently, the Company provided data from its Phase
I dose
escalation study of VQD-002 at the H. Lee Moffitt Cancer Center in
Tampa,
FL where 13 patients with advanced solid tumors refractory to standard
therapy and whose tumors had high-levels of p-Akt were enrolled to
date
and 8 patients were evaluable for response. The data showed that
VQD-002
was well-tolerated when administered on a weekly schedule. One patient
with melanoma achieved stable disease for 8 months. No drug related
toxicities were observed. The study had three dosing cohorts in which
patients were dosed intravenously weekly over one hour on days 1,
8 and
15, every 28 days at doses of 15, 25 and 35 mg/m2.
At the 35mg/m2 dose, Akt modulation was observed in two out of three
patients evaluable, and there was a reduction of Akt IHC scores from
+2 to
0 and +2 to +1. Additionally, one patient at the 15mg/m2 and one
patient
dosed at 25mg/m2 experienced stable disease for three months. Over
the
next several months, we expect to initiate Phase II combination clinical
trials.
|
·
|
Xyfid™.
Xyfid™
is a topical, adjunctive therapy which has shown early clinical promise
in
the treatment and prevention of Hand-Foot Syndrome, or HFS, a common,
often dose-limiting and potentially life-threatening complication
of
several drug regimens, commonly used in the treatment of patients
with
breast, colon, and other cancers. HFS, also known as palmar-plantar
erythrodysesthesia syndrome, is commonly seen in patients receiving
capecitabine (Xeloda™) and has been associated with other
fluoropyrimidines and anthracyclines. In addition, HFS is being seen
in
patients receiving some of the newer tyrosine kinase class of therapies
sorafenib (Nexavar™). Incidence of HFS can be as high as 50% in patients
receiving initial chemotherapy with higher dose regimens of capecitabine.
In the first half of 2008, we expect to initiate Phase II clinical
trials.
|
· |
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.
|
Exhibit No.
|
Description
|
||
4.1
|
Form
of senior convertible promissory note issued by VioQuest Pharmaceuticals,
Inc. on June 29, 2007 and July 3, 2007 (incorporated by reference
to
Exhibit 4.1 of the Company’s Form 8-K filed July 6, 2007)
|
||
4.2
|
Form
of warrant issued to investors by VioQuest Pharmaceuticals, Inc.
on June
29, 2007 and July 3, 2007 (incorporated by reference to Exhibit 4.1
of the
Company’s Form 8-K filed July 6, 2007)
|
||
10.1
|
Form
of Note and Warrant Purchase Agreement between VioQuest Pharmaceuticals
and various investors accepted as of June 29, 2007 and July 3, 2007
(incorporated by reference to Exhibit 4.1 of the Company’s Form 8-K filed
July 6, 2007)
|
||
10.2
|
Sublease
dated July 16, 2007 between the Company and Chiral Quest Acquisition
Corp.
|
||
31.1
|
Certification
of Chief Executive Officer
|
||
31.2
|
Certification
of Chief Financial Officer
|
||
32.1
|
Certifications
of Chief Executive and Chief Financial Officer pursuant to Section
906 of
the Sarbanes-Oxley Act of 2002
|
VIOQUEST
PHARMACEUTICALS, INC.
|
|||
Date:
November 14, 2007
|
By:
|
/s/
Brian Lenz
|
|
Brian
Lenz
Interim
Chief Executive Officer and Chief
Financial
Officer
|