· |
VQD-001
- Sodium Stibogluconate (SSG).
VQD-001 is a pentavalent antimonial drug that has been used for over
50
years in parts of Africa and Asia for the treatment of leishmaniasis
(a
protozoan disease). As published by the World Health Organization,
leishmaniasis currently threatens 350 million men, women, and children
in
88 countries around the world. This drug is currently being used
to treat
military personnel serving in parts of the world where this disease
is
prevalent. In collaboration with the U.S. Army, we are pursuing the
development of VQD-001 for the treatment of leishmaniasis and intend
to
file a new drug application or NDA, with the U.S. Food and Drug
Administration (FDA) in the first half of 2007. Already, VQD-001
has been
designated orphan drug status by the FDA in the first half of 2006
for the
treatment of leishmaniasis. In other development, results from several
preclinical studies, especially those conducted at the Cleveland
Clinic
showed that VQD-001 is an inhibitor of multiple protein tyrosine
phosphatases (PTPases), specifically the SRC homology PTPase (SHP-1
&
SHP-2). These intracellular enzymes are involved in signaling pathways
of
many receptor-linked tyrosine kinases which are involved in growth,
proliferation and differentiation of cancer cells. Inhibition of
these
enzymes with VQD-001 can trigger apoptosis of malignant cells. This
cytotoxic effect, coupled with its potential ability to enhance the
body’s
immune system, through improved cytokine signaling and t-cell formation,
suggest that VQD-001 has potential as an anti-cancer agent. On August
14,
2006, we received an acceptance letter for our investigational new
drug
application (IND) for VQD-001 from the FDA. The FDA completed their
review
of our IND submission and have concluded that the clinical investigation
(s) described in the protocol may begin. VQD-001 is currently being
evaluated in combination with IFN a-2b
in a 24-patient investigator-sponsored Phase I clinical trial at
the
Cleveland Clinic Taussig Cancer Center in refractory solid tumors,
lymphoma and myeloma. We are also currently evaluating the safety,
tolerability and activity of VQD-001 in a separate, company-sponsored
study of up to a 54-patient Phase I/IIa clinical trial at MD Anderson
Cancer Center in patients with advanced malignancies and solid tumors
that
have been non-responsive in previous cytokine therapy.
|
· |
VQD-002
- Triciribine-Phosphate (TCN-P). Clinical
studies of VQD-002, a nucleoside analog, by the National Cancer Institute
in the 1980s and early 1990s showed compelling anti-cancer activities.
More recently, investigators at the Moffitt Cancer Center of the
University of South Florida were able to demonstrate from preclinical
studies that VQD-002’s mechanism of action inhibits Akt phosphorylation
(protein kinase - B) , which is found to be over activated and
over-expressed in various malignancies, including, breast, ovarian,
colorectal, pancreatic and leukemias. Clinically, the over expression
of
phosphorylated Akt is associated with poor prognosis, resistance
to
chemotherapy and shortened survival time of cancer patients. On
April 11, 2006, we received an acceptance letter for our investigational
new drug application (IND) for VQD-002 from the FDA. The FDA completed
their review of our IND submission and have concluded that the clinical
investigations (s) described in the protocol may begin. We
are currently evaluating the safety, tolerability and safety of VQD-002
and its impact of its ability to reduce Akt phosphorylation in two
Phase
I/IIa clinical trials, including one at the Moffitt Cancer Center
in up to
42 patients with hyper-activated, phosphorylated Akt in colorectal,
pancreatic, breast and ovarian tumors and a second clinical study
up to a
40-patient trial at the MD Anderson Cancer Center in hematologic
tumors,
particularly, leukemia.
|
Page
|
|
Unaudited
Interim Financial Statements:
|
|
Condensed
Consolidated Balance Sheets as of September 30, 2006 and December
31,
2005
|
F-2
|
Condensed
Consolidated Statements of Operations for the Three and Nine Months
Ended
September 30, 2006 and 2005
|
F-3
|
Condensed
Consolidated Statement of Changes in Stockholders’ Equity (Deficiency) for
the Nine Months ended September 30, 2006
|
F-4
|
Condensed
Consolidated Statements of Cash Flows for the Nine Months Ended
September
30, 2006 and 2005
|
F-5
|
Notes
to Unaudited Condensed Consolidated Financial Statements
|
F-6
|
ASSETS
|
September
30, 2006
(Unaudited)
|
December
31, 2005
(Note
1A)
|
|||||
CURRENT
ASSETS
|
|||||||
Cash
and cash equivalents
|
$
|
823,129
|
$
|
6,021,399
|
|||
Prepaid
clinical research organization costs
|
180,238
|
-
|
|||||
Other
current assets
|
89,054
|
9,945
|
|||||
Current
assets associated with discontinued operations (See Note
2)
|
1,269,445
|
892,092
|
|||||
Total
Current Assets
|
2,361,866
|
6,923,436
|
|||||
NON-CURRENT
ASSETS ASSOCIATED WITH DISCONTINUED OPERATIONS (See Note
2)
|
1,336,484
|
1,424,883
|
|||||
PROPERTY
AND EQUIPMENT, NET
|
31,191
|
21,276
|
|||||
SECURITY
DEPOSITS
|
9,708
|
9,708
|
|||||
TOTAL
ASSETS
|
$
|
3,739,249
|
$
|
8,379,303
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
612,044
|
$
|
275,077
|
|||
Accrued
compensation
|
213,609
|
346,833
|
|||||
Accrued
expenses
|
267,405
|
48,167
|
|||||
Note
payable - Paramount BioCapital (See Note 4)
|
264,623
|
264,623
|
|||||
Current
liabilities associated with discontinued operations (See Note
2)
|
769,669
|
1,105,594
|
|||||
TOTAL
LIABILITIES
|
2,127,350
|
2,040,294
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
STOCKHOLDERS'
EQUITY
|
|||||||
Preferred
stock; $0.001 par value: 10,000,000 shares authorized, 0 shares issued
and
outstanding at September 30, 2006 and December 31, 2005
|
-
|
-
|
|||||
Common
stock; $0.001 par value: 100,000,000 shares authorized at September
30,
2006 and December 31, 2005, 46,729,519 shares issued and outstanding
at
September 30, 2006 and December 31, 2005
|
46,729
|
46,729
|
|||||
Additional
paid-in capital
|
27,399,677
|
26,561,672
|
|||||
Accumulated
deficit
|
(25,834,507
|
)
|
(20,269,392
|
)
|
|||
Total
Stockholders' Equity
|
1,611,899
|
6,339,009
|
|||||
TOTAL
LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
3,739,249
|
$
|
8,379,303
|
For
the Three Months Ended September 30, 2006
|
For
the Three Months Ended September 30, 2005
|
For
the Nine Months Ended September 30, 2006
|
For
the Nine
Months
Ended September 30, 2005
|
||||||||||
REVENUE
|
-
|
-
|
-
|
-
|
|||||||||
COST
OF GOODS SOLD
|
-
|
-
|
-
|
-
|
|||||||||
GROSS
PROFIT
|
-
|
-
|
-
|
-
|
|||||||||
OPERATING
EXPENSES
|
|||||||||||||
Management
and consulting fees
|
$
|
167,379
|
$
|
212,159
|
$
|
171,707
|
$
|
243,184
|
|||||
Research
and development
|
273,876
|
-
|
933,599
|
-
|
|||||||||
Selling,
general and administrative
|
504,848
|
564,225
|
2,172,519
|
1,459,607
|
|||||||||
Depreciation
and amortization
|
1,268
|
525
|
3,804
|
2,149
|
|||||||||
Total
Operating Expenses
|
947,371
|
776,909
|
3,281,629
|
1,704,940
|
|||||||||
LOSS
FROM CONTINUING OPERATIONS
|
(947,371
|
)
|
(776,909
|
)
|
(3,281,629
|
)
|
(1,704,940
|
)
|
|||||
INTEREST
INCOME, NET
|
36,246
|
2,463
|
85,361
|
14,203
|
|||||||||
LOSS
FROM CONTINUING OPERATIONS
|
(911,125
|
)
|
(774,446
|
)
|
(3,196,268
|
)
|
(1,690,737
|
)
|
|||||
LOSS
FROM DISCONTINUED OPERATIONS
|
(973,892
|
)
|
(843,215
|
)
|
(2,368,847
|
)
|
(2,372,397
|
)
|
|||||
NET
LOSS
|
$
|
(1,885,017
|
)
|
$
|
(1,617,661
|
)
|
$
|
(5,565,115
|
)
|
$
|
(4,063,134
|
)
|
|
NET
LOSS PER COMMON SHARE:
|
|||||||||||||
CONTINUING
OPERATIONS
|
$
|
(0.02
|
)
|
$
|
(0.04
|
)
|
$
|
(0.08
|
)
|
$
|
(0.10
|
)
|
|
DISCONTINUED
OPERATIONS
|
(0.03
|
)
|
(0.05
|
)
|
(0.07
|
)
|
(0.13
|
)
|
|||||
BASIC
LOSS PER SHARE
|
$
|
(0.05
|
)
|
$
|
(0.09
|
)
|
$
|
(0.15
|
)
|
$
|
(0.23
|
)
|
|
WEIGHTED
AVERAGE SHARES OUTSTANDING - BASIC AND DILUTED
|
38,165,124
|
17,852,100
|
38,165,124
|
17,852,100
|
Common
Stock
|
||||||||||||||||
Shares
|
Amount
|
Additional
Paid-In
Capital
|
Accumulated
Deficit
|
Total
Stockholders’
Equity
|
||||||||||||
Balance,
January 1, 2006
|
46,729,519
|
$
|
46,729
|
$
|
26,561,672
|
$
|
(20,269,392
|
)
|
$
|
6,339,009
|
||||||
Employee
and director
stock-based compensation
|
-
|
-
|
749,680
|
-
|
749,680
|
|||||||||||
Stock-based
compensation to consultants
|
-
|
-
|
88,325
|
-
|
88,325
|
|||||||||||
Net
loss
|
-
|
-
|
-
|
(5,565,115
|
)
|
(5,565,115
|
)
|
|||||||||
Balance,
September 30, 2006
|
46,729,519
|
$
|
46,729
|
$
|
27,399,677
|
$
|
(25,834,507
|
)
|
$
|
1,611,899
|
For
the Nine
Months
Ended
September
30, 2006
|
For
the Nine
Months
Ended
September
30, 2005
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss
|
$
|
(5,565,115
|
)
|
$
|
(4,063,134
|
)
|
|
Loss
from discontinued operations
|
2,368,847
|
2,372,397
|
|||||
Loss
from continuing operations
|
(3,196,268
|
)
|
(1,690,737
|
)
|
|||
Adjustments
to reconcile net loss from continuing operations to net cash used
in
continuing operating activities:
|
|||||||
Depreciation
and amortization
|
3,804
|
2,149
|
|||||
Impact
of employee and director stock-based compensation
|
589,673
|
-
|
|||||
Impact
of consultant stock-based compensation
|
33,119
|
190,000
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Prepaid
clinical research organization costs
|
(180,238
|
)
|
-
|
||||
Other
assets
|
(79,109
|
)
|
(80,041
|
)
|
|||
Accounts
payable
|
336,967
|
437,749
|
|||||
Accrued
compensation
|
(133,224
|
)
|
139,000
|
||||
Accrued
expenses
|
219,238
|
-
|
|||||
Net
Cash Used in Continuing Operating Activities
|
(2,406,038
|
)
|
(1,001,880
|
)
|
|||
Net
Cash Used in Discontinued Operating Activities
|
(2,633,511
|
)
|
(1,247,322
|
)
|
|||
Net
Cash Used in Operating Activities
|
(5,039,549
|
)
|
(2,249,202
|
)
|
|||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|||||||
Payments
for purchased equipment
|
(14,987
|
)
|
(18,529
|
)
|
|||
Net
Cash Used in Continuing Investing Activities
|
(14,987
|
)
|
(18,529
|
)
|
|||
Net
Cash Used in Discontinued Investing Activities
|
(143,734
|
)
|
(536,034
|
)
|
|||
Net
Cash Used in Investing Activities
|
(158,721
|
)
|
(554,563
|
)
|
|||
NET
DECREASE IN CASH AND CASH EQUIVALENTS
|
(5,198,270
|
)
|
(2,803,765
|
)
|
|||
CASH
AND CASH EQUIVALENTS - BEGINNING OF PERIOD
|
6,021,399
|
3,065,547
|
|||||
CASH
AND CASH EQUIVALENTS - END OF PERIOD
|
$
|
823,129
|
$
|
261,782
|
|
Three
Months Ended
September
30, 2005
|
|
Nine
Months Ended
September
30, 2005
|
||||
Net
loss from continuing operations
|
$
|
(774,446
|
)
|
$
|
(1,690,737
|
)
|
|
Deduct:
Stock-based employee compensation
|
|||||||
expense
determined under fair value based
|
|||||||
method
for all awards, net of taxes
|
(68,466
|
)
|
(198,769
|
)
|
|||
Pro
forma, net loss from continuing operations
|
$
|
(842,912
|
)
|
$
|
(1,889,506
|
)
|
|
Net
loss from discontinued operations
|
(843,215
|
)
|
(2,372,397
|
)
|
|||
Deduct:
Stock-based employee compensation
|
|||||||
expense
determined under fair value based
|
|||||||
method
for all awards, net of taxes
|
(74,215
|
)
|
(187,035
|
)
|
|||
Pro
forma, net loss from discontinued operations
|
(917,430
|
)
|
(2,559,432
|
)
|
|||
Pro
forma, net loss
|
$
|
(1,760,342
|
)
|
$
|
(4,448,938
|
)
|
|
Basic
and diluted net loss per share from continuing operations, as
reported
|
$
|
(0.04
|
)
|
$
|
(0.10
|
)
|
|
Basic
and diluted net loss per share from continuing operations, pro
forma
|
$
|
(0.05
|
)
|
$
|
(0.11
|
)
|
|
Basic
and diluted net loss per share from discontinued operations, as
reported
|
$
|
(0.05
|
)
|
$
|
(0.13
|
)
|
|
Basic
and diluted net loss per share from discontinued operations, pro
forma
|
$
|
(0.05
|
)
|
$
|
(0.14
|
)
|
|
Basic
and diluted net loss per share, as reported
|
$
|
(0.09
|
)
|
$
|
(0.23
|
)
|
|
Basic
and diluted net loss per share, pro forma
|
$
|
(0.10
|
)
|
$
|
(0.25
|
)
|
|
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
|||||||||||
|
2006
|
2005
|
2006
|
2005
|
|||||||||
Term
|
7
years
|
10
years
|
7
years
|
10
years
|
|||||||||
Volatility
|
217
|
%
|
147%-157
|
%
|
210%-217
|
%
|
108%-157
|
%
|
|||||
Dividend
yield
|
0.0
|
%
|
0.0
|
%
|
0.0
|
%
|
0.0
|
%
|
|||||
Risk-free
interest rate
|
4.96
|
%
|
4.2
|
%
|
4.37%-4.96
|
%
|
4.1%-4.4
|
%
|
|||||
Forfeiture
rate
|
25
|
%
|
22%-25
|
%
|
0
|
%
|
Number
of Options
|
Weighted
Average Exercise Price
|
Weighted
Average Remaining Contractual Life
|
Aggregate
Intrinsic Value
|
||||||||||
Balance,
January 1, 2006
|
4,975,852
|
$
|
1.10
|
||||||||||
Options
granted
|
1,212,000
|
$
|
0.83
|
||||||||||
Options
cancelled
|
(386,000
|
)
|
$
|
0.89
|
|||||||||
Options
outstanding, September 30, 2006
|
5,801,852
|
$
|
1.05
|
7.2
|
$
|
2,523,591
|
|||||||
Options
exercisable, September 30, 2006
|
2,108,282
|
$
|
1.28
|
5.8
|
$
|
190,670
|
|
Three
Months Ended
September
30, 2005
|
|
Nine
Months Ended
September
30, 2005
|
||||
Net
loss
|
$
|
(939
|
)
|
$
|
(11,924
|
)
|
|
Basic
and diluted net loss per share, as reported
|
$
|
(0.03
|
)
|
$
|
(0.31
|
)
|
|
Weighted
average common shares outstanding - basic and diluted
|
37,965
|
37,965
|