Delaware
|
58-1486040
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification No.)
|
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o (Do not check if
a
smaller reporting company)
|
Smaller
reporting company x
|
Page
|
||
PART
I
|
FINANCIAL
INFORMATION
|
|
Item
1.
|
Unaudited
Condensed Consolidated Financial Statements
|
1
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
13
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
21
|
Item
4T.
|
Controls
and Procedures
|
21
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1A.
|
Risk
Factors
|
22
|
Item
6.
|
Exhibits
|
23
|
Signatures
|
23
|
|
Index
To Exhibits Filed With This Report
|
24
|
June 30, 2008
(Unaudited)
|
December 31, 2007
(Note 1A)
|
||||||
ASSETS
|
|||||||
CURRENT
ASSETS
|
|||||||
Cash
and cash equivalents
|
$
|
814,477
|
$
|
694,556
|
|||
Prepaid
clinical research costs
|
268,978
|
189,359
|
|||||
Deferred
financing costs
|
-
|
357,581
|
|||||
Other
current assets
|
48,509
|
66,836
|
|||||
Total
Current Assets
|
1,131,964
|
1,308,332
|
|||||
PROPERTY
AND EQUIPMENT, NET
|
30,139
|
34,789
|
|||||
SECURITY
DEPOSITS
|
15,232
|
15,232
|
|||||
TOTAL
ASSETS
|
$
|
1,177,335
|
$
|
1,358,353
|
|||
LIABILITIES,
MANDATORILY REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS'
DEFICIENCY
|
|||||||
CURRENT
LIABILITIES
|
|||||||
Accounts
payable
|
$
|
2,171,150
|
$
|
1,873,500
|
|||
Accrued
compensation and related taxes
|
150,574
|
373,460
|
|||||
Other
accrued expenses
|
371,803
|
665,273
|
|||||
Convertible
notes, net of unamortized debt discount of $0 and $917,612
|
-
|
2,930,388
|
|||||
TOTAL
LIABILITIES
|
2,693,527
|
5,842,621
|
|||||
MANDATORILY
REDEEMABLE CONVERTIBLE PREFERRED STOCK, $0.001 par value; 10,000,000
shares authorized
|
|||||||
Series
A mandatorily redeemable convertible preferred stock; 3,464.5 shares
issued and outstanding at June 30, 2008
|
627,390
|
-
|
|||||
Series
B mandatorily redeemable convertible preferred stock; 3,405.165
shares
issued and outstanding at June 30, 2008
|
3,405,165
|
-
|
|||||
Dividends
payable in shares of common stock
|
122,103
|
-
|
|||||
TOTAL
MANDATORILY REDEEMABLE CONVERTIBLE PREFERRED
STOCK
|
4,154,658
|
-
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
STOCKHOLDERS'
DEFICIENCY
|
|||||||
Common
stock, $0.001 par value; 200,000,000 shares authorized; 5,461,644
and
5,462,112 shares issued and outstanding at June 30, 2008 and December
31,
2007, respectively
|
5,462
|
5,462
|
|||||
Additional
paid-in capital
|
38,676,402
|
34,942,567
|
|||||
Accumulated
deficit
|
(44,352,714
|
)
|
(39,432,297
|
)
|
|||
Total
Stockholders' Deficiency
|
(5,670,850
|
)
|
(4,484,268
|
)
|
|||
TOTAL
LIABILITIES, MANDATORILY REDEEMABLE CONVERTIBLE PREFERRED STOCK
AND
STOCKHOLDERS' DEFICIENCY
|
$
|
1,177,335
|
$
|
1,358,353
|
For the Three
Months Ended
June 30, 2008
|
For the Three
Months Ended
June 30, 2007
|
For the Six
Months Ended
June 30, 2008
|
For the Six
Months Ended
June 30, 2007
|
||||||||||
OPERATING
EXPENSES
|
|||||||||||||
Research
and development
|
$
|
472,801
|
$
|
950,844
|
$
|
1,451,895
|
$
|
2,319,655
|
|||||
General
and administrative
|
554,753
|
1,192,399
|
1,245,092
|
2,106,050
|
|||||||||
Total
Operating Expenses
|
1,027,554
|
2,143,243
|
2,696,987
|
4,425,705
|
|||||||||
LOSS
FROM OPERATIONS
|
(1,027,554
|
)
|
(2,143,243
|
)
|
(2,696,987
|
)
|
(4,425,705
|
)
|
|||||
INTEREST
(EXPENSE)/INCOME, NET
|
(103,110
|
)
|
6,391
|
(1,514,658
|
)
|
32,075
|
|||||||
LOSS
FROM CONTINUING OPERATIONS
|
(1,130,664
|
)
|
(2,136,852
|
)
|
(4,211,645
|
)
|
(4,393,630
|
)
|
|||||
LOSS
FROM DISCONTINUED OPERATIONS
|
-
|
(335,422
|
)
|
-
|
(596,897
|
)
|
|||||||
NET
LOSS
|
(1,130,664
|
)
|
(2,472,274
|
)
|
(4,211,645
|
)
|
(4,990,527
|
)
|
|||||
BENEFICIAL
CONVERSION FEATURE
|
(708,772
|
)
|
-
|
(708,772
|
)
|
-
|
|||||||
NET
LOSS APPLICABLE TO COMMON STOCKHOLDERS
|
$
|
(1,839,436
|
)
|
$
|
(2,472,274
|
)
|
$
|
(4,920,417
|
)
|
$
|
(4,990,527
|
)
|
|
NET
LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS:
|
|||||||||||||
CONTINUING
OPERATIONS
|
$
|
(0.38
|
)
|
$
|
(0.56
|
)
|
$
|
(1.00
|
)
|
$
|
(0.95
|
)
|
|
DISCONTINUED
OPERATIONS
|
-
|
(0.09
|
)
|
-
|
(0.13
|
)
|
|||||||
NET
LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS – BASIC AND DILUTED
|
$
|
(0.38
|
)
|
$
|
(0.65
|
)
|
$
|
(1.00
|
)
|
$
|
(1.08
|
)
|
|
WEIGHTED
AVERAGE COMMON SHARES USED IN COMPUTING NET LOSS PER SHARE APPLICABLE
TO
COMMON STOCKHOLDERS – BASIC AND DILUTED
|
4,905,081
|
3,816,512
|
4,905,254
|
4,605,672
|
Additional
|
Total
|
|||||||||||||||
Common Stock
|
Paid-In
|
Accumulated
|
Stockholders'
|
|||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Deficiency
|
||||||||||||
Balance,
January 1, 2008
|
5,462,112
|
$
|
5,462
|
$
|
34,942,567
|
$
|
(39,432,297
|
)
|
$
|
(4,484,268
|
)
|
|||||
Net
loss applicable to common stockholders for the six months ended June
30, 2008
|
(4,920,417
|
)
|
(4,920,417
|
)
|
||||||||||||
Proceeds
from issuance of Series A mandatorily redeemable convertible preferred
stock, net of financing costs of $233,714
|
2,054,800
|
2,054,800
|
||||||||||||||
Beneficial
conversion feature associated with conversion of Series B mandatorily
redeemable convertible preferred stock into Series A mandatorily
redeemable convertible preferred stock
|
708,772
|
708,772
|
||||||||||||||
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
|
(122,390
|
)
|
(122,390
|
)
|
||||||||||||
Discount
on convertible notes
|
62,166
|
62,166
|
||||||||||||||
Fractional
shares paid out in cash as a result of the 1-for-10 reverse stock
split
|
(468
|
)
|
(374
|
)
|
(374
|
)
|
||||||||||
Stock-based
compensation to employees
|
360,233
|
360,233
|
||||||||||||||
Stock-based
compensation to consultants and finder
|
(822
|
)
|
(822
|
)
|
||||||||||||
Balance,
June 30, 2008
|
5,461,644
|
$
|
5,462
|
$
|
38,676,402
|
$
|
(44,352,714
|
)
|
$
|
(5,670,850
|
)
|
For the Six
Months Ended
June 30, 2008
|
For the Six
Months Ended
June 30, 2007
|
||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|||||||
Net
loss applicable to common stockholders
|
$
|
(4,920,417
|
)
|
$
|
(4,990,527
|
)
|
|
Loss
from discontinued operations
|
-
|
596,897
|
|||||
Loss
From Continuing Operations
|
(4,920,417
|
)
|
(4,393,630
|
)
|
|||
Adjustments
to reconcile loss from continuing operations to net cash used in
continuing operating activities:
|
|||||||
Depreciation
|
4,650
|
4,126
|
|||||
Stock-based
compensation to employees
|
360,233
|
534,730
|
|||||
Stock-based
compensation to consultants and finder
|
(822
|
)
|
54,093
|
||||
Amortization
of debt discount and deferred financing fees
|
1,399,524
|
-
|
|||||
Dividends
payable on mandatorily redeemable convertible preferred
stock
|
122,103
|
-
|
|||||
Beneficial
conversion
feature
|
708,772
|
||||||
Changes
in operating assets and liabilities:
|
|||||||
Prepaid
clinical research costs
|
(79,619
|
)
|
(28,694
|
)
|
|||
Other
assets
|
18,326
|
139,438
|
|||||
Accounts
payable
|
297,650
|
1,191,524
|
|||||
Accrued
expenses
|
(516,356
|
)
|
161,145
|
||||
Net
Cash Used In Continuing Operating Activities
|
(2,605,956
|
)
|
(2,337,268
|
)
|
|||
Net
cash used in discontinued operating activities
|
-
|
(356,217
|
)
|
||||
Net
Cash Used In Operating Activities
|
(2,605,956
|
)
|
(2,693,485
|
)
|
|||
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
|
-
|
(26,698
|
)
|
||||
Net
Cash Used In Investing Activities
|
-
|
(28,975
|
)
|
||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|||||||
Proceeds
from issuance of mandatorily redeemable convertible preferred stock
with
warrants, net of cash costs of $233,714
|
2,726,251
|
-
|
|||||
Payments
for fractional shares as a result of the 1-for-10 reverse stock
split
|
(374
|
)
|
|||||
Proceeds
from issuance of convertible notes with warrants, net of cash costs
of
$245,450
|
-
|
2,722,050
|
|||||
Repayment
of note payable
|
-
|
(100,000
|
)
|
||||
Net
Cash Provided By Continuing Financing Activities
|
2,725,877
|
2,622,050
|
|||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
119,921
|
(100,410
|
)
|
||||
CASH
AND CASH EQUIVALENTS – BEGINNING OF PERIOD
|
694,556
|
2,931,265
|
|||||
CASH
AND CASH EQUIVALENTS – END OF PERIOD
|
$
|
814,477
|
$
|
2,830,855
|
|||
Supplemental
Schedule of Non-Cash Investing and Financing
Activities:
|
|||||||
Value
of warrants issued to placement agent in connection with issuances
of
mandatorily redeemable convertible Series B
Preferred stock
|
$
|
505,706
|
$
|
-
|
|||
Value
of beneficial conversion feature related to mandatorily redeemable
convertible preferred stock
|
$
|
708,772
|
$
|
-
|
|||
Value
of warrants issued to placement agent in connection with issuances
of
convertible notes
|
$
|
-
|
$
|
356,425
|
|||
Value
of beneficial conversion feature related to convertible
notes
|
$
|
-
|
$
|
590,334
|
|||
Conversion
of convertible notes into mandatorily redeemable convertible series
B
preferred stock
|
$
|
3,405,165
|
$
|
-
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
||||||||||||
2008
|
2007
|
2008
|
2007
|
||||||||||
Term
|
|
|
7
years
|
|
|
7
years
|
|
|
7
years
|
|
|
7
years
|
|
Volatility
|
|
|
310-409
|
%
|
|
238
|
%
|
|
298-409
|
%
|
|
232-238
|
%
|
Dividend
yield
|
|
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
|
0.0
|
%
|
Risk-free
interest rate
|
|
|
3.0-3.8
|
%
|
|
4.6-4.9
|
%
|
|
3.0-3.8
|
%
|
|
4.6-4.9
|
%
|
Forfeiture
rate
|
|
0%-26
|
%
|
22
|
%
|
0%-26
|
%
|
22
|
%
|
Number of
Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual Life
(Years)
|
Aggregate
Intrinsic Value
|
||||||||||
Balance,
January 1, 2008
|
1,013,339
|
$
|
9.86
|
(1)
|
|
|
|||||||
Granted
|
560,000
|
$
|
0.71
|
(1)
|
|
|
|||||||
Exercised
|
-
|
-
|
|
|
|||||||||
Forfeited
or expired
|
(67,733
|
)
|
$
|
4.38
|
|
|
|||||||
Outstanding
at June 30, 2008
|
1,505,606
|
$
|
2.05
|
3.05
|
$
|
-
|
|||||||
Exercisable
at June 30, 2008
|
525,769
|
$
|
4.78
|
2.88
|
$
|
-
|
(1)
|
Reflects
the impact of the June 13, 2008 repricing of 771,558 shares
subject to
stock options to $0.54 that had original exercise prices
ranging from
$19.60 to $1.20.
|
Term
|
5
years
|
|||
Volatility
|
240
|
%
|
||
Dividend
yield
|
0.0
|
%
|
||
Risk-free
interest rate
|
4.9-5.0
|
%
|
Term
|
5
years
|
||
Volatility
|
301%
|
- |
310%
|
Dividend
yield
|
0.0%
|
||
Risk-free
interest rate
|
2.4%
|
- |
2.6%
|
·
|
has
the same intended use as the predicate; and
|
·
|
has
the same technological characteristics as the
predicate.
|
(1)
|
The
application must be to treat or prevent a “neglected tropical disease” as
defined by the law and regulation;
|
(2)
|
The
drug or biologic must be a new molecular
entity;
|
(3)
|
The
application must have been submitted after enactment of the Food
&
Drug Administration Amendments Act (September 25,
2007);
|
(4)
|
It
must qualify for priority review under existing FDA procedures;
and
|
(5)
|
It
must be approved by the agency.
|
Three Months Ended June 30,
|
||||||||||
2008
|
2007
|
Cumulative
amounts during
development
|
||||||||
Lenocta
|
$
|
68,376
|
$
|
426,683
|
$
|
3,233,700
|
||||
VQD-002
|
286,928
|
259,663
|
3,713,518
|
|||||||
Xyfid
|
117,497
|
264,498
|
1,312,558
|
|||||||
Total
|
$
|
472,801
|
$
|
950,844
|
$
|
8,259,776
|
Drug Candidate
|
|||||||||||||
Lenocta
|
VQD-002
|
Xyfid
|
Three Months
Ended June 30,
2008
|
||||||||||
Clinical
Research Costs
|
$
|
7,208
|
$
|
142,565
|
$
|
25,283
|
$
|
175,056
|
|||||
Labor
Costs
|
29,842
|
77,588
|
11,936
|
119,366
|
|||||||||
Regulatory
/ Legal Fees
|
22,576
|
58,698
|
24,031
|
105,305
|
|||||||||
Licensing
/ Milestone Fees
|
8,750
|
6,250
|
-
|
15,000
|
|||||||||
Other
|
-
|
1,827
|
56,247
|
58,074
|
|||||||||
Total
|
$
|
68,376
|
$
|
286,928
|
$
|
117,497
|
$
|
472,801
|
Drug Candidate
|
|||||||||||||
Lenocta
|
VQD-002
|
Xyfid
|
Three Months
Ended June 30,
2007
|
||||||||||
Clinical
Research Costs
|
$ |
62,606
|
$ |
100,691
|
$ |
27,454
|
$ |
190,751
|
|||||
Labor
Costs
|
165,814
|
105,815
|
- |
271,629
|
|||||||||
Regulatory
/ Legal Fees
|
161,161
|
16,791
|
-
|
177,952
|
|||||||||
Licensing
Fees
|
8,750
|
6,250
|
-
|
15,000
|
|||||||||
Other
|
28,352
|
30,116
|
237,044
|
295,512
|
|||||||||
Total
|
$
|
426,683
|
$
|
259,663
|
$
|
264,498
|
$
|
950,844
|
Six Months Ended June 30,
|
||||||||||
2008
|
2007
|
Cumulative
amounts during
development
|
||||||||
Lenocta
|
$
|
353,706
|
$
|
883,209
|
$
|
3,233,700
|
||||
VQD-002
|
817,541
|
737,287
|
3,713,518
|
|||||||
Xyfid
|
280,648
|
699,159
|
1,312,558
|
|||||||
Total
|
$
|
1,451,895
|
$
|
2,319,655
|
$
|
8,259,776
|
Drug
Candidate
|
|||||||||||||
Lenocta
|
VQD-002
|
Xyfid
|
Six Months
Ended June 30,
2008
|
||||||||||
Clinical
Research Costs
|
$
|
167,967
|
$
|
317,957
|
$
|
44,252
|
$
|
530,176
|
|||||
Labor
Costs
|
94,245
|
245,036
|
37,698
|
376,979
|
|||||||||
Regulatory
/ Legal Fees
|
73,694
|
191,605
|
44,478
|
309,777
|
|||||||||
Licensing
/ Milestone Fees
|
17,500
|
12,500
|
-
|
30,000
|
|||||||||
Other
|
300
|
50,443
|
154,220
|
204,963
|
|||||||||
Total
|
$
|
353,706
|
$
|
817,541
|
$
|
280,648
|
$
|
1,451,895
|
Drug
Candidate
|
|||||||||||||
Lenocta
|
VQD-002
|
Xyfid
|
Six Months
Ended June 30,
2007
|
||||||||||
Clinical
Research Costs
|
$ |
245,103
|
$
|
394,779
|
$ |
27,454
|
$
|
667,336
|
|||||
Labor
Costs
|
303,042 | 183,041 |
-
|
486,083
|
|||||||||
Regulatory
/ Legal Fees
|
238,025
|
76,839
|
37,490
|
352,354
|
|||||||||
Licensing
Fees
|
17,502
|
12,500
|
369,588
|
399,590
|
|||||||||
Other
|
79,537
|
70,128
|
264,627
|
414,292
|
|||||||||
Total
|
$
|
883,209
|
$
|
737,287
|
$
|
699,159
|
$
|
2,319,655
|
·
|
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;
and
|
·
|
our
ability to protect our proprietary
technology.
|
Exhibit
No.
|
Description
|
||
10.1
|
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 Company’s Form 8-K filed on June 19,
2008)
|
||
10.2
|
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 Company’s Form 8-K filed on June 19, 2008)
|
||
10.3
|
Form
of Director Stock Option Agreement dated June 13, 2008 (incorporated
by
reference to Exhibit 10.4 of the Company’s Form 8-K filed on June 19,
2008)
|
||
10.4
|
Form
of Amendment to Stock Option Agreement dated June 13, 2008 (incorporated
by reference to Exhibit 10.5 of the Company’s Form 8-K filed on June 19,
2008)
|
||
10.5
|
List
of Stock Option Agreements to be amended by the Form attached hereto
as
Exhibit 10.3 (incorporated by reference to Exhibit 10.6 of the Company’s
Form 8-K filed on June 19, 2008)
|
||
10.6
|
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 Company’s Form
8-K filed on June 19, 2008)
|
||
10.7
|
Amendment
dated June 13, 2008 to Stock Option Agreement dated November 21,
2007
between VioQuest Pharmaceuticals, Inc. and Michael Becker for 29,974
shares (incorporated by reference to Exhibit 10.8 of the Company’s Form
8-K filed on June 19, 2008)
|
||
10.8
|
Employment
Amendment dated July 18, 2008 between VioQuest Pharmaceuticals, Inc.
and
Christopher P. Schnittker (incorporated by reference to Exhibit 10.1
of
the Company’s Form 8-K filed on July 24, 2008)
|
||
10.9
|
2003
Stock Option Plan, as amended (incorporated by reference to Exhibit
10.2
of the Company’s Form 8-K filed on July 24, 2008)
|
||
31.1
|
Certification
of Chief Executive Officer
|
||
31.2
|
Certification
of Chief Financial Officer
|
||
32.1
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
Section
906 of the Sarbanes-Oxley Act of 2002
|
VIOQUEST PHARMACEUTICALS, INC.
|
|||
Date: August 19, 2008
|
By:
|
/s/ Michael D. Becker
|
|
Michael D. Becker
President & Chief Executive Officer
|
|||
Date: August 19, 2008
|
By:
|
/s/ Christopher P. Schnittker
|
|
Christopher P. Schnittker
Vice President & Chief Financial Officer
|
Exhibit
No.
|
Description
|
||
31.1
|
Certification
of Chief Executive Officer
|
||
31.2
|
Certification
of Chief Financial Officer
|
||
32.1
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to
Section
906 of the Sarbanes-Oxley Act of 2002
|