Delaware
|
84-1475642
|
(State
or Other Jurisdiction of Incorporation or Organization)
|
(IRS
Employer Identification No.)
|
|
|
1180
Avenue of the Americas, 19th Floor,
New York, NY
|
10036
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
Large
accelerated filer o
|
|
Accelerated
filer x
|
|
Non-accelerated
filer o
(Do
not check if a smaller reporting company)
|
|
Smaller
reporting company o
|
|
|
Page
|
PART
I
|
FINANCIAL
INFORMATION
|
|
|
|
|
Item
1.
|
Financial
Statements
|
|
|
|
|
|
Balance
Sheets as of March 31, 2008 (unaudited) and December 31,
2007
|
3
|
|
|
|
|
Statement
of Operations for the three months ended March 31, 2008 and 2007
(unaudited) and for the period from inception (September 9, 2003)
to March
31, 2008 (unaudited)
|
4
|
|
|
|
|
Statement
of Cash Flows for the three months ended March 31, 2008 and 2007
(unaudited) and for the period from inception (September 9, 2003)
to March
31, 2008 (unaudited)
|
5
|
|
|
|
|
Statement
of Changes in Convertible Preferred Stock and Stockholders’
Equity/(Deficit) for the period from inception (September 9, 2003)
to
March 31, 2008 (unaudited)
|
6
|
|
|
|
|
Notes
to Unaudited Financial Statements
|
7
|
|
|
|
Item
2.
|
Management’s
Discussion and Analysis
|
12
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosure About Market Risk
|
18
|
Item
4.
|
Controls
and Procedures
|
18
|
|
|
|
PART
II
|
OTHER
INFORMATION
|
|
Item
1.
|
Legal
Proceedings
|
18
|
|
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
18
|
|
|
|
Item
3.
|
Defaults
Under Senior Securities
|
18
|
|
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
18
|
|
|
|
Item
5.
|
Other
Information
|
18
|
|
|
|
Item
6.
|
Exhibits
|
19
|
|
Signatures
|
20
|
|
Exhibit
Index
|
21
|
March 31,
|
December 31,
|
||||||
2008
|
2007
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
27,487,427
|
$
|
35,028,798
|
|||
Prepaid
expenses and other current assets
|
335,720
|
498,864
|
|||||
Total
current assets
|
27,823,147
|
35,527,662
|
|||||
|
|||||||
Property
and equipment, net
|
727,129
|
746,421
|
|||||
|
|||||||
Deposits
|
95,497
|
95,497
|
|||||
Other
non-current assets
|
358,373
|
356,881
|
|||||
Total
assets
|
$
|
29,004,146
|
$
|
36,726,461
|
|||
|
|||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
2,648,178
|
$
|
2,909,170
|
|||
Accrued
expenses
|
4,082,723
|
3,396,480
|
|||||
Total
current liabilities
|
6,730,901
|
6,305,650
|
|||||
|
|||||||
Deferred
rent
|
58,960
|
50,988
|
|||||
Total
liabilities
|
6,789,861
|
6,356,638
|
|||||
|
|||||||
Commitments
and contingencies
|
|||||||
|
|||||||
Stockholders'
equity:
|
|||||||
Common
stock, $.001 par value; 280,000,000 shares authorized; 21,398,964
and
21,298,964 shares issued and outstanding at March 31, 2008 and December
31, 2007, respectively
|
21,399
|
21,299
|
|||||
Preferred
stock, $0.01 par value; 30,000,000 shares authorized and no shares
issued
and outstanding
|
-
|
-
|
|||||
Additional
paid-in capital
|
70,141,607
|
69,674,151
|
|||||
Warrants
issued
|
20,503,894
|
20,503,894
|
|||||
Deficit
accumulated during the development stage
|
(68,452,615
|
)
|
(59,829,521
|
)
|
|||
Total
stockholders' equity
|
22,214,285
|
30,369,823
|
|||||
Total
liabilities and stockholders' equity
|
$
|
29,004,146
|
$
|
36,726,461
|
For the three
|
For the three
|
From inception
|
||||||||
|
months
|
months
|
(September 9, 2003)
|
|||||||
ended
|
ended
|
through
|
||||||||
|
March 31, 2008
|
March 31, 2007
|
March 31, 2008
|
|||||||
(unaudited)
|
(unaudited)
|
(unaudited)
|
||||||||
Research
contract revenue
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
Operating
expenses and other income:
|
||||||||||
Research
and development, including costs of research contracts
|
6,074,577
|
3,426,513
|
43,178,971
|
|||||||
General
and administrative
|
2,744,701
|
1,990,018
|
28,978,995
|
|||||||
Total
operating expenses
|
8,819,278
|
5,416,531
|
72,157,966
|
|||||||
Loss
from operations
|
(8,819,278
|
)
|
(5,416,531
|
)
|
(72,157,966
|
)
|
||||
Interest
income
|
196,184
|
375,845
|
3,705,351
|
|||||||
Net
loss
|
$
|
(8,623,094
|
)
|
$
|
(5,040,686
|
)
|
$
|
(68,452,615
|
)
|
|
|
||||||||||
Basic
and diluted net loss per share
|
$
|
(0.41
|
)
|
$
|
(0.29
|
)
|
||||
Weighted
average common shares outstanding used to compute basic and diluted
net
loss per share
|
21,228,964
|
17,636,919
|
For the period
|
||||||||||
|
For the
|
For the
|
from inception
|
|||||||
three months
|
three months
|
(September 9, 2003)
|
||||||||
|
ended
|
ended
|
through
|
|||||||
March 31, 2008
|
March 31, 2007
|
March 31, 2008
|
||||||||
(unaudited)
|
(unaudited)
|
(unaudtied)
|
||||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(8,623,094
|
)
|
$
|
(5,040,686
|
)
|
$
|
(68,452,615
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating activities:
|
||||||||||
Depreciation
and amortization
|
88,693
|
69,131
|
831,151
|
|||||||
Non-cash
stock-based compensation
|
467,556
|
323,694
|
5,590,673
|
|||||||
Loss
on disposal of fixed assets
|
-
|
-
|
8,423
|
|||||||
Change
in operating assets and liabilities:
|
||||||||||
(Increase)
decrease in:
|
||||||||||
Prepaid
expenses and other current assets
|
163,144
|
(111,635
|
)
|
(335,720
|
)
|
|||||
Other
noncurrent assets
|
(1,492
|
)
|
(121,241
|
)
|
(358,373
|
)
|
||||
Deposits
|
-
|
-
|
(95,497
|
)
|
||||||
Increase
(decrease) in:
|
||||||||||
Accounts
payable
|
(260,992
|
)
|
179,541
|
2,648,178
|
||||||
Accrued
expenses
|
686,243
|
239,904
|
4,082,723
|
|||||||
Deferred
rent
|
7,972
|
(150
|
)
|
58,960
|
||||||
Net
cash used in operating activates
|
(7,471,970
|
)
|
(4,461,442
|
)
|
(56,022,097
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchases
of property and equipment
|
(69,401
|
)
|
(219,363
|
)
|
(1,566,703
|
)
|
||||
Decrease
in short-term investments
|
-
|
1,555,164
|
-
|
|||||||
Net
cash provided by (used in) investing activities
|
(69,401
|
)
|
1,335,801
|
(1,566,703
|
)
|
|||||
Cash
flows from financing activities:
|
||||||||||
Proceeds
from the exercise of stock options
|
-
|
-
|
65,596
|
|||||||
Stockholders'
capital contribution
|
-
|
-
|
500,000
|
|||||||
Proceeds
from issuance of common stock and warrants, net
|
-
|
28,970,915
|
67,751,035
|
|||||||
Proceeds
from issuance of preferred stock, net
|
-
|
-
|
16,759,596
|
|||||||
Net
cash provided by financing activities
|
-
|
28,970,915
|
85,076,227
|
|||||||
Net
increase (decrease) in cash and cash equivalents
|
(7,541,371
|
)
|
25,845,274
|
27,487,427
|
||||||
Cash
and cash equivalents, beginning of period
|
35,028,798
|
26,855,450
|
-
|
|||||||
Cash
and cash equivalents, end of period
|
$
|
27,487,427
|
$
|
52,700,724
|
$
|
27,487,427
|
||||
|
||||||||||
Supplementary
disclosure of cash flow information:
|
||||||||||
Cash
paid for interest
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
Cash
paid for income taxes
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
Supplementary
disclosure of noncash investing and financing
activities:
|
||||||||||
|
||||||||||
Warrants
issued to placement agents and investors, in connection with with
private placement
|
$
|
-
|
$
|
5,432,793
|
$
|
20,208,217
|
||||
Preferred
stock conversion to common stock
|
$
|
-
|
$
|
-
|
$
|
16,759,596
|
||||
|
||||||||||
Warrants
converted to common shares
|
$
|
-
|
$
|
-
|
$
|
17,844
|
Convertible Preferred Stock and Warrants
|
Stockholder's Equity (Deficit)
|
|||||||||||||||||||||||||||
Warrants to
|
||||||||||||||||||||||||||||
Purchase
|
Deficit
|
|||||||||||||||||||||||||||
Series A
|
Accumulated
|
Total
|
||||||||||||||||||||||||||
Series A
|
Convertible
|
Additional
|
During The
|
Stockholders'
|
||||||||||||||||||||||||
Convertible Preferred Stock
|
Preferred Stock
|
Common Stock
|
Paid-in
|
Development
|
Equity/
|
|||||||||||||||||||||||
Shares
|
Amount
|
Warrants
|
Shares
|
Amount
|
Capital
|
Warrants
|
Stage
|
(Deficit)
|
||||||||||||||||||||
Stockholders' contribution, September 9, 2003
|
-
|
$
|
-
|
$
|
-
|
250,487
|
$
|
250
|
$
|
499,750
|
$
|
-
|
$
|
-
|
$
|
500,000
|
||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(160,136
|
)
|
(160,136
|
)
|
|||||||||||||||||
Balance
at December 31, 2003
|
-
|
-
|
-
|
250,487
|
250
|
499,750
|
-
|
(160,136
|
)
|
339,864
|
||||||||||||||||||
Issuance
of common stock
|
-
|
-
|
-
|
2,254,389
|
2,254
|
4,497,746
|
-
|
-
|
4,500,000
|
|||||||||||||||||||
Issuance
of common stock for services
|
-
|
-
|
-
|
256,749
|
257
|
438,582
|
-
|
-
|
438,839
|
|||||||||||||||||||
Fair
value of options/warrants issued for nonemployee services
|
-
|
-
|
-
|
-
|
-
|
13,240
|
251,037
|
-
|
264,277
|
|||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(5,687,297
|
)
|
(5,687,297
|
)
|
|||||||||||||||||
|
||||||||||||||||||||||||||||
Balance
at December 31, 2004
|
-
|
-
|
-
|
2,761,625
|
2,761
|
5,449,318
|
251,037
|
(5,847,433
|
)
|
(144,317
|
)
|
|||||||||||||||||
|
||||||||||||||||||||||||||||
Issuance
of Series A convertible preferred stock (net of expenses of $1,340,263
and
warrant cost of $1,682,863)
|
4,197,946
|
15,076,733
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||
Fair
value of warrants to purchase Series A convertible preferred
stock
|
-
|
-
|
1,682,863
|
-
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||||
Issuance
of Common stock to EasyWeb Shareholders
|
-
|
-
|
-
|
189,922
|
190
|
(190
|
)
|
-
|
-
|
-
|
||||||||||||||||||
Conversion
of Series A convertible preferred stock @ $0.001 into $0.001
common stock
on September 13, 2005 at an exchange ratio of .500974
|
(4,197,946
|
)
|
(15,076,733
|
)
|
(1,682,863
|
)
|
4,197,823
|
4,198
|
15,072,535
|
1,682,863
|
-
|
16,759,596
|
||||||||||||||||
Issuance
of common stock for options
|
-
|
-
|
-
|
98,622
|
99
|
4,716
|
-
|
4,815
|
||||||||||||||||||||
Fair
value of options/warrants issued for nonemployee services
|
-
|
-
|
-
|
-
|
-
|
54,115
|
44,640
|
-
|
98,755
|
|||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(9,516,923
|
)
|
(9,516,923
|
)
|
|||||||||||||||||
Balance
at December 31, 2005
|
-
|
-
|
-
|
7,247,992
|
7,248
|
20,580,494
|
1,978,540
|
(15,364,356
|
)
|
7,201,926
|
||||||||||||||||||
Issuance
of common stock in private placement, net of expenses
$2,719,395
|
-
|
-
|
-
|
7,991,256
|
7,991
|
21,179,568
|
-
|
-
|
21,187,559
|
|||||||||||||||||||
Issuance
of warrants
|
-
|
-
|
-
|
-
|
-
|
-
|
13,092,561
|
-
|
13,092,561
|
|||||||||||||||||||
Issuance
of common stock for services rendered
|
-
|
-
|
-
|
25,000
|
25
|
106,225
|
-
|
-
|
106,250
|
|||||||||||||||||||
Stock
based compensation for employees
|
-
|
-
|
-
|
-
|
-
|
2,776,408
|
-
|
-
|
2,776,408
|
|||||||||||||||||||
Issuance
of common stock due to exercise of stock options
|
-
|
-
|
-
|
5,845
|
6
|
25,186
|
-
|
-
|
25,192
|
|||||||||||||||||||
Issuance
of common stock due to exercise of stock warrants
|
-
|
-
|
-
|
2,806
|
3
|
(3
|
)
|
-
|
-
|
-
|
||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(17,856,919
|
)
|
(17,856,919
|
)
|
|||||||||||||||||
Balance
at December 31, 2006
|
-
|
-
|
-
|
15,272,899
|
15,273
|
44,667,878
|
15,071,101
|
(33,221,275
|
)
|
26,532,977
|
||||||||||||||||||
Issuance
of common stock in private placement, net of expenses
$1,909,090
|
-
|
-
|
-
|
5,910,049
|
5,910
|
23,532,212
|
-
|
-
|
23,538,122
|
|||||||||||||||||||
Issuance
of warrants
|
-
|
-
|
-
|
-
|
-
|
-
|
5,432,793
|
-
|
5,432,793
|
|||||||||||||||||||
Stock-based
compensation for employees
|
-
|
-
|
-
|
-
|
-
|
1,318,096
|
-
|
-
|
1,318,096
|
|||||||||||||||||||
Stock-based
compensation for non-employee
|
-
|
-
|
-
|
-
|
-
|
120,492
|
-
|
-
|
120,492
|
|||||||||||||||||||
Issuance
of common stock due to exercise of stock options
|
-
|
-
|
-
|
46,016
|
46
|
35,543
|
-
|
-
|
35,589
|
|||||||||||||||||||
Issuance
of restricted stock
|
-
|
-
|
-
|
70,000
|
70
|
(70
|
)
|
-
|
-
|
-
|
||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(26,608,246
|
)
|
(26,608,246
|
)
|
|||||||||||||||||
Balance
at December 31, 2007
|
-
|
-
|
-
|
21,298,964
|
21,299
|
69,674,151
|
20,503,894
|
(59,829,521
|
)
|
30,369,823
|
||||||||||||||||||
Stock-based
compensation for employees
|
-
|
-
|
-
|
-
|
-
|
467,556
|
-
|
-
|
467,556
|
|||||||||||||||||||
Issuance
of restricted stock
|
-
|
-
|
-
|
100,000
|
100
|
(100
|
)
|
-
|
-
|
-
|
||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(8,623,094
|
)
|
(8,623,094
|
)
|
|||||||||||||||||
Balance
at March 31, 2008
|
-
|
$
|
-
|
$
|
-
|
21,398,964
|
$
|
21,399
|
$
|
70,141,607
|
$
|
20,503,894
|
$
|
(68,452,615
|
)
|
$
|
22,214,285
|
Item 1.
|
UNAUDITED
FINANCIAL STATEMENTS
|
1. |
BASIS
OF PRESENTATION AND
OPERATIONS
|
2. |
RECENT
ACCOUNTING PRONOUNCEMENTS
|
2.
|
RECENT
ACCOUNTING
PRONOUNCEMENTS…CONTINUED
|
3.
|
STOCK-BASED
COMPENSATION AND STOCK OPTION
PLAN
|
|
Three months
ended March 31,
2008
|
Three months
ended March 31,
2007
|
For the period from
inception
(September 9, 2003)
through
March 31, 2008
|
|||||||
|
|
|
|
|||||||
Research
and development, including costs of research contracts
|
$
|
180,111
|
$
|
143,210
|
$
|
1,100,477
|
||||
General
and administrative
|
287,445
|
180,484
|
3,461,583
|
|||||||
Share-based
compensation expense before tax
|
467,556
|
323,694
|
4,562,060
|
|||||||
Income
tax benefit
|
—
|
—
|
—
|
|||||||
Net
compensation expense
|
$
|
467,556
|
$
|
323,694
|
$
|
4,562,060
|
3.
|
STOCK-BASED
COMPENSATION AND STOCK OPTION
PLAN…CONTINUED
|
|
Number
of
Shares
|
Weighted
Average
Exercise Price
|
Weighted
Average
Remaining
Contractual
Term
(Years)
|
Aggregate
Intrinsic
Value
|
|||||||||
Outstanding,
January 1, 2008
|
2,797,000
|
$
|
3.81
|
||||||||||
Granted
|
101,000
|
3.06
|
|||||||||||
Exercised
|
—
|
—
|
|||||||||||
Canceled
|
63,334
|
4.73
|
|
|
|||||||||
Outstanding,
March 31, 2008
|
2,834,666
|
$
|
3.77
|
8.28
|
$
|
1,083,632
|
|||||||
Options
exercisable, March 31, 2008
|
1,384,165
|
$
|
3.56
|
7.24
|
$
|
956,417
|
3.
|
STOCK-BASED
COMPENSATION AND STOCK OPTION
PLAN…CONTINUED
|
|
Restricted
Stock
|
|
Weighted-
Average Grant
Date Fair Value
|
||||
Non-vested
at January 1, 2007
|
—
|
$
|
—
|
||||
Granted
|
70,000
|
2.73
|
|||||
Vested
|
—
|
—
|
|||||
Canceled
|
—
|
—
|
|||||
Non-vested
at December 31, 2007
|
70,000
|
$
|
2.73
|
||||
Granted
|
100,000
|
3.25
|
|||||
Vested
|
—
|
—
|
|||||
Canceled
|
—
|
—
|
|||||
Non-vested
at March 31, 2008
|
170,000
|
$
|
3.04
|
4.
|
INCOME
TAXES
|
|
·
|
Darinaparsin
is an organic arsenic compound covered by issued patents and pending
patent applications in the U.S. and in foreign countries. A form
of
commercially available inorganic arsenic (arsenic trioxide [Trisenox
®
];
“ATO”) has been approved in the United States and the European Union for
the treatment of acute promyelocytic leukemia (“APL”), a precancerous
condition. ATO is on the compendia listing for the therapy of multiple
myeloma, and has been studied for the treatment of various other
cancers.
Nevertheless, ATO has been shown to be toxic to the heart, liver,
and
brain, which limits its use as an anti-cancer agent. Inorganic arsenic
has
also been shown to cause cancer of the skin and lung in humans. The
toxicity of arsenic is generally correlated to its accumulation in
organs
and tissues. Our preclinical and clinical studies to date have
demonstrated that darinaparsin is considerably less toxic than inorganic
arsenic, particularly with regard to heart toxicity. Similar results
have
been reported for other organic compounds. In
vitro
testing of darinaparsin using the National Cancer Institute’s human cancer
cell panel detected activity against lung, colon, brain, melanoma,
ovarian, and kidney cancer. Moderate activity was detected against
breast
and prostate cancer. In addition to solid tumors, in
vitro
testing in both the National Cancer Institute’s cancer cell panel and
in
vivo
testing in a leukemia animal model demonstrated substantial activity
against hematological cancers (cancers of the blood and blood-forming
tissues) such as leukemia, lymphoma, myelodysplastic syndromes, and
multiple myeloma. Preclinical studies have also established
anti-angiogenic properties of darinaparsin, provided support for
the
development of an oral form of the drug, and has established synergy
of
darinaparsin in combination with other approved anti-cancer
agents.
|
|
|
Phase
I testing of the intravenous form of darinaparsin in solid tumors
and
multiple myeloma and other hematological cancers has been completed.
The
Company has reported signs of clinical activity and a safety profile
in
these studies as predicted by preclinical results. The Company is
presently conducting phase II studies in advanced myeloma, in certain
other hematological cancers, and primary liver cancer, and has reported
preliminary results from the first two trials. The Company has recently
initiated a phase I program for an oral form of darinaparsin. Study
results from the oral phase I trial and the ongoing IV phase II trials
will guide the development plan for darinaparsin including an opportunity
for partnering.
|
|
|
|
|
·
|
Several
proprietary forms of palifosfamide, or isophosphoramide mustard (“IPM”),
the active metabolite of ifosfamide that is also related to
cyclophosphamide, have been developed. Patent applications for
pharmaceutical composition and method of use have been filed in the
U.S.
and internationally. Like cyclophosphamide and ifosfamide, palifosfamide
is an alkylating agent. The Company believes that cyclophosphamide
is the
most widely used alkylating agent in cancer therapy, with significant
use
to treat breast cancer and non-Hodgkin’s lymphoma. Ifosfamide has been
shown to be effective in high dose by itself or in combination with
other
anticancer agents in treating sarcoma and lymphoma. Unlike
cyclophosphamide, ifosfamide is approved by the FDA only as a treatment
for testicular cancer. Although ifosfamide-based treatment generally
represents the standard of care for sarcoma, it is not licensed for
this
indication by the U.S. FDA. Our preclinical studies have shown that,
in
animal and laboratory models, palifosfamide exhibits activity against
leukemia and solid tumors. These studies also indicate that palifosfamide
may have a better safety profile than ifosfamide or cyclophosphamide
because it does not appear to produce several known toxic metabolites,
such as acrolein, which is toxic to the kidneys and bladder. The
presence
of acrolein can mandate the administration of a protective agent
called
mesna, which is inconvenient and expensive. Chloroacetaldehyde is
an
additional metabolite of ifosfamide that is toxic to the central
nervous
system, causing “fuzzy brain” syndrome for which there is currently no
protective measure. Similar toxicity concerns pertain to high-dose
cyclophosphamide, which is widely used in bone marrow and blood cell
transplantation. Because palifosfamide is independently active without
acrolein or chloroacetaldehyde metabolites, the Company believes
that the
administration of its proprietary form of palifosfamide (without
the need
for co-administration of mesna) may avoid many of the toxicities
of
ifosfamide and cyclophosphamide without compromising efficacy. In
certain
preclinical studies, palifosfamide appeared to show activity against
ifosfamide- and/or cyclophosphamide-resistant cancer cell lines.
Also,
encouraging results have been obtained when palifosfamide was combined
with doxorubicin, an agent approved to treat sarcoma, in
preclinical cancer models.
|
|
|
|
|
|
Phase
II testing of the intravenous form of palifosfamide to treat advanced
sarcoma is completed. In both phase I and phase II testing, palifosfamide
has been administered without the “uroprotectant” mesna, and the
toxicities associated with acrolein and chloroacetaldehyde have not
been
observed. Kidney toxicity has been identified as the dose limiting
toxicity. The Company has reported signs of clinical activity in
the phase
II study, which is now nearing completion. Following review of the
preclinical combination studies, clinical sarcoma data, and discussion
with sarcoma experts, the Company has initiated a phase I/II study
of
palifosfamide and doxorubicin in sarcoma patients, primarily. The
Company
is planning a phase II randomized study designed to compare doxorubicin
plus palifosfamide to doxorubicin in patients with advanced sarcoma.
The
study is expected to be initiated in the fourth quarter of
2008.
|
|
·
|
Indibulin
is a novel, oral small molecular-weight inhibitor of tubulin
polymerization that was acquired from Baxter Healthcare. The microtubule
component tubulin is one of the most well-established drug targets
in
cancer. Microtubule inhibitors interfere with the dynamics of tubulin
polymerization resulting in inhibition of chromosome segregation
during
mitosis and consequently inhibition of cell division. A number of
IV
anticancer drugs that target tubulin, such as Taxol ®
(paclitaxel, Taxotere®
(docetaxel)
and vinca alkaloid family members, vincristine and vinorelbine, are
on the
market. This class of agents is typically the mainstay of therapy
in a
wide variety of indications. In spite of their effectiveness, the
use of
these drugs is also associated with significant toxicities, notably
peripheral neurotoxicity.
Indibulin
is an orally available compound. Preclinical studies demonstrate
significant and broad antitumor activity (including activity against
taxane-refractory and multi-drug resistant cell lines and xenografts).
The
cytotoxic activity of indibulin was demonstrated in several rodent
and
human tumor cell lines derived from prostate, brain, breast, pancreas,
lung, ovary, and cervical tumor tissues and in rodent tumor and xenograft
models. In addition, indibulin was effective against multidrug resistant
tumor cell lines (breast, lung leukemia) both in
vitro
and in
vivo.
Indibulin is potentially safer than other tubulin inhibitors and
there has
been no neurotoxicity at therapeutic doses in animals and in the
ongoing
phase I trials. Indibulin has also been successfully tested preclinically
for synergy with approved anti-cancer agents. The availability of
an oral
formulation of indibulin creates significant commercial opportunity
because no oral formulations of paclitaxel or related compounds are
currently on the market in the United States.
There
are three ongoing phase I studies in patients with advanced solid
tumors
which are nearing completion. The Company has reported signs of clinical
activity at well-tolerated doses and without clinically relevant
peripheral neuropathy. Following encouraging results obtained with
indibulin in combination with erlotinib, docetaxel or 5-FU in preclinical
models, the first of two phase I/II combination studies, has
been initiated with the second expected in the third quarter of this
year.
Based on the results obtained in the phase I/II drug-combination
studies,
a pahse II randomized study is expected to
be initiated.
|
·
|
Fees
and milestone payments required under the license agreements relating
to
our existing product candidates;
|
|
|
·
|
Clinical
trial expenses, including the costs incurred with respect to the
conduct
of clinical trials for darinaparsin, palifosfamide and indibulin,
and
preclinical costs associated with back-up candidates;
|
|
|
·
|
Costs
related to the scale-up and manufacture of darinaparsin, palifosfamide
and
indibulin;
|
|
|
·
|
Rent
for our facilities; and
|
|
|
·
|
General
corporate and working capital, including general and administrative
expenses.
|
·
|
Changes
in the focus and direction of our research and development programs,
including the acquisition and pursuit of development of new product
candidates;
|
·
|
Competitive
and technical advances;
|
·
|
Costs
of commercializing any of the product candidates;
and
|
·
|
Costs
of filing, prosecuting, defending and enforcing any patent claims
and any
other intellectual property rights, or other
developments.
|
|
Payments
due by Period
|
||||||||||||||||||
|
Total
|
2009
|
2010
|
2011
|
2012
|
2013 and
thereafter
|
|||||||||||||
Operating
lease
|
$
|
1,422,648
|
$
|
472,222
|
$
|
456,872
|
$
|
223,835
|
$
|
189,563
|
80,156
|
Exhibit
No.
|
|
Description
|
10.1(1)(*)
|
|
Employment
Agreement dated as of January 8, 2008
between ZIOPHARM Oncology, Inc. and Jonathan J. Lewis, MD,
PhD.
|
31.1
|
|
Certification
of Chief Executive Officer pursuant to Securities Exchange Act
Rule
13a-15(e)/15d-15(e) as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification
of Chief Financial Officer pursuant to Securities Exchange Act
Rule
13a-15(e)/15d-15(e) as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
|
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350,
as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
|
|
32.2
|
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350,
as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
(1)
|
Incorporated by reference to our Annual Report on Form 10-QSB, filed on February 21, 2008. | |
(*)
|
Compensatory
plan or
arrangement.
|
|
|
|
|
ZIOPHARM
ONCOLOGY, INC.
|
|
|
|
|
Date: May
12, 2008
|
By:
|
/s/ Jonathan
Lewis
|
Jonathan
Lewis, M.D., Ph.D.
Chief
Executive Officer
(Principal
Executive Officer)
|
Date:
May 12, 2008
|
By:
|
/s/ Richard
Bagley
|
Richard
Bagley
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
|
Exhibit
No.
|
|
Description
|
10.1(1)(*)
|
|
Employment
Agreement dated as of January 8, 2008
between ZIOPHARM Oncology, Inc. and Jonathan J. Lewis, MD,
PhD.
|
31.1
|
|
Certification
of Chief Executive Officer pursuant to Securities Exchange Act Rule
13a-15(e)/15d-15(e) as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
|
|
Certification
of Chief Financial Officer pursuant to Securities Exchange Act Rule
13a-15(e)/15d-15(e) as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
|
|
Certification
of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
|
|
|
32.2
|
|
Certification
of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of
2002.
|
(1)
|
Incorporated by reference to our Annual Report on Form 10-QSB, filed on February 21, 2008. | |
(*)
|
Compensatory
plan or
arrangement.
|
1. |
I
have reviewed this quarterly report on Form 10-Q of ZIOPHARM Oncology,
Inc.;
|
2. |
Based
on my knowledge, this report does not contain any untrue statement
of a
material fact or omit to state a material fact necessary to make
the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3. |
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects
the
financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this
report;
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal control over financial reporting (as defined in Exchange
Act
Rules 13a-15(f) and 15d-15(f)) for
the registrant and have:
|
a) |
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to
ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is
being
prepared;
|
b) |
Designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision,
to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness
of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
|
d) |
Disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely
to
materially affect, the registrant’s internal control over financial
reporting; and
|
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on
our most recent evaluation of internal control over financial reporting,
to the registrant’s auditors and the audit committee of the registrant’s
board of directors (or persons performing the equivalent
functions):
|
a) |
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information;
and
|
b) |
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s internal control
over financial reporting.
|
Date:
May 12, 2008
|
|
|
|
|
|
|
|
/s/
Jonathan
Lewis
|
|
|
|
Jonathan
Lewis, M.D., Ph.D.
Principal
Executive Officer
|
1. |
I
have reviewed this quarterly report on Form 10-Q of ZIOPHARM Oncology,
Inc.;
|
2. |
Based
on my knowledge, this report does not contain any untrue statement
of a
material fact or omit to state a material fact necessary to make
the
statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this
report;
|
3. |
Based
on my knowledge, the financial statements, and other financial information
included in this report, fairly present in all material respects
the
financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this
report;
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal control over financial reporting (as defined in Exchange
Act
Rules 13a-15(f) and 15d-15(f)) for
the registrant and have:
|
a) |
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to
ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is
being
prepared;
|
b) |
Designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision,
to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness
of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
|
d) |
Disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably likely
to
materially affect, the registrant’s internal control over financial
reporting; and
|
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on
our most recent evaluation of internal control over financial reporting,
to the registrant’s auditors and the audit committee of the registrant’s
board of directors (or persons performing the equivalent
functions):
|
a) |
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information;
and
|
b) |
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s internal control
over financial reporting.
|
Date:
May 12, 2008
|
|
|
|
|
|
/s/
Richard
E. Bagley
|
|
|
Richard
E. Bagley
Principal
Financial Officer
|
|
(1)
|
The
Report fully complies with the requirements of Section 13(a) or 15(d)
of
the Securities Exchange Act of 1934;
and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and result of operations of the
Company.
|
/s/
Jonathan
Lewis
|
|
|
Jonathan
Lewis, M.D., Ph.D.
Principal
Executive Officer
May
12, 2008
|
|
(1)
|
The
Report fully complies with the requirements of Section 13(a) or 15(d)
of
the Securities Exchange Act of 1934;
and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and result of operations of the
Company.
|
/s/
Richard
E. Bagley
|
|
|
Richard
E. Bagley
Principal
Financial Officer
May
12, 2008
|