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)
|
Page
|
||||
PART
I
|
|
FINANCIAL
INFORMATION
|
|
|
Item
1.
|
|
Financial
Statements
|
|
|
|
|
Balance
Sheets as of September 30, 2007 (unaudited) and December 31,
2006
|
|
3
|
|
|
|
|
|
|
|
Statement
of Operations for the three and nine months ended September 30, 2007
and
2006 (unaudited) and for the period from inception (September 9,
2003) to
September 30, 2007 (unaudited)
|
|
4
|
|
|
|
|
|
|
|
Statement
of Cash Flows for the nine months ended September 30, 2007 and 2006
(unaudited) and for the period from inception (September 9, 2003)
to
September 30, 2007 (unaudited)
|
|
5
|
|
|
|
|
|
|
|
Statement
of Changes in Convertible Preferred Stock and Stockholders’
Equity/(Deficit) for the nine months ended September 30, 2007 (unaudited)
and for the years ended December 31, 2006, 2005, 2004 and for the
period
from inception (September 9, 2003) to December 31, 2003
|
|
6
|
|
|
|
|
|
|
|
Notes
to Unaudited Financial Statements
|
|
7
|
|
|
|
|
|
Item
2.
|
|
Management’s
Discussion and Analysis or Plan of Operation
|
|
12
|
|
|
|
|
|
Item
3.
|
|
Controls
and Procedures
|
|
21
|
|
|
|
|
|
PART II
|
|
OTHER
INFORMATION
|
|
|
Item
1.
|
|
Legal
Proceedings
|
|
22
|
|
|
|
|
|
Item
2.
|
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
|
22
|
|
|
|
|
|
Item
3.
|
|
Defaults
Under Senior Securities
|
|
22
|
|
|
|
|
|
Item
4.
|
|
Submission
of Matters to a Vote of Security Holders
|
|
22
|
|
|
|
|
|
Item
5.
|
|
Other
Information
|
|
23
|
|
|
|
|
|
Item
6.
|
|
Exhibits
|
|
23
|
|
|
Signatures
|
|
24
|
|
|
Exhibit
Index
|
|
25
|
Item
1. UNAUDITED
FINANCIAL STATEMENTS
|
September 30,
|
December
31,
|
||||||
2007
|
2006
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
40,938,624
|
$
|
26,855,450
|
|||
Short-term
investments
|
-
|
1,555,164
|
|||||
Prepaid
expenses and other current assets
|
687,015
|
462,789
|
|||||
Total
current assets
|
41,625,639
|
28,873,403
|
|||||
Property
and equipment, net
|
719,218
|
451,247
|
|||||
Deposits
|
100,997
|
9,367
|
|||||
Other
non current assets
|
355,256
|
178,080
|
|||||
Total
assets
|
$
|
42,801,110
|
$
|
29,512,097
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
1,637,837
|
$
|
776,128
|
|||
Accrued
expenses
|
3,431,879
|
2,161,914
|
|||||
Total
current liabilities
|
5,069,716
|
2,938,042
|
|||||
Deferred
rent
|
36,313
|
41,078
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders'
equity:
|
|||||||
Common
stock, $.001 par value; 280,000,000 shares authorized; 21,220,614
and
15,272,899 shares
issued and outstanding at September 30, 2007 and December 31, 2006,
respectively
|
21,221
|
15,273
|
|||||
Additional
paid-in capital
|
69,300,494
|
44,667,878
|
|||||
Warrants
issued
|
20,503,894
|
15,071,101
|
|||||
Deficit
accumulated during the development stage
|
(52,130,528
|
)
|
(33,221,275
|
)
|
|||
Total
stockholders' equity
|
37,695,081
|
26,532,977
|
|||||
Total
liabilities and stockholders' equity
|
$
|
42,801,110
|
$
|
29,512,097
|
For the period
|
||||||||||||||||
For the three
|
For the three
|
For the nine
|
For the nine
|
from inception
|
||||||||||||
months
|
months
|
months
|
months
|
(September 9, 2003)
|
||||||||||||
ended
|
ended
|
ended
|
ended
|
through
|
||||||||||||
September 30, 2007
|
September 30, 2006
|
September 30, 2007
|
September 30, 2006
|
September 30, 2007
|
||||||||||||
Research
contract revenue
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||
Operating
expenses and other income:
|
|
|
|
|
|
|||||||||||
Research
and development including costs of research contracts
|
5,568,872
|
2,097,617
|
13,342,389
|
6,545,986
|
31,454,148
|
|||||||||||
General
and administrative
|
2,293,212
|
1,832,361
|
7,131,809
|
6,345,450
|
23,788,245
|
|||||||||||
Total
operating expenses
|
7,862,084
|
3,929,978
|
20,474,198
|
12,891,436
|
55,242,393
|
|||||||||||
|
|
|
|
|
||||||||||||
Loss
from operations
|
(7,862,084
|
)
|
(3,929,978
|
)
|
(20,474,198
|
)
|
(12,891,436
|
)
|
(55,242,393
|
)
|
||||||
|
|
|
|
|
||||||||||||
Interest
income
|
538,718
|
475,476
|
1,564,945
|
853,184
|
3,111,865
|
|||||||||||
Net
loss
|
$
|
(7,323,366
|
)
|
$
|
(3,454,502
|
)
|
$
|
(18,909,253
|
)
|
$
|
(12,038,252
|
)
|
$
|
(52,130,528
|
)
|
|
Basic
and diluted net loss per share
|
$
|
(0.35
|
)
|
$
|
(0.23
|
)
|
$
|
(0.94
|
)
|
$
|
(1.03
|
)
|
|
|||
Weighted
average common shares outstanding used to compute basic and diluted
net
loss per share
|
21,196,607
|
15,264,368
|
20,018,480
|
11,662,722
|
|
For the Period
|
||||||||||
from Inception
|
||||||||||
For the
|
For the
|
(September 9,
|
||||||||
nine months
|
nine months
|
2003)
|
||||||||
ended
|
ended
|
through
|
||||||||
September 30, 2007
|
September 30, 2006
|
September 30, 2007
|
||||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(18,909,253
|
)
|
$
|
(12,038,252
|
)
|
$
|
(52,130,528
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Depreciation
and amortization
|
345,890
|
117,155
|
654,995
|
|||||||
Non-cash
stock-based compensation
|
1,079,048
|
2,530,436
|
4,763,577
|
|||||||
Loss/(gain)
on disposal of fixed assets
|
4,098
|
(1,165
|
)
|
2,933
|
||||||
Change
in operating assets and liabilites:
|
||||||||||
Increase
in:
|
||||||||||
Prepaid
expenses and other current assets
|
(224,226
|
)
|
(102,948
|
)
|
(687,015
|
)
|
||||
Other
noncurrent assets
|
(177,176
|
)
|
(52,876
|
)
|
(355,256
|
)
|
||||
Deposits
|
(91,630
|
)
|
(3,667
|
)
|
(100,997
|
)
|
||||
Increase
(decrease) in:
|
||||||||||
Accounts
payable
|
861,709
|
307,780
|
1,637,837
|
|||||||
Accrued
expenses
|
1,269,965
|
718,142
|
3,431,879
|
|||||||
Deferred
rent
|
(4,765
|
)
|
4,415
|
36,313
|
||||||
Net
cash used in operating activities
|
(15,846,340
|
)
|
(8,520,980
|
)
|
(42,746,262
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchases
of property and equipment
|
(617,959
|
)
|
(141,270
|
)
|
(1,377,146
|
)
|
||||
Decrease
(increase) in short-term investments
|
1,555,164
|
(1,536,357
|
)
|
-
|
||||||
Net
cash provided by (used in) investing activities
|
937,205
|
(1,677,627
|
)
|
(1,377,146
|
)
|
|||||
Cash
flows from financing activities:
|
||||||||||
Proceeds
from the exercise of stock options
|
21,394
|
-
|
51,401
|
|||||||
Stockholders'
capital contribution
|
-
|
-
|
500,000
|
|||||||
Proceeds
from issuance of common stock, net
|
28,970,915
|
34,280,120
|
67,751,035
|
|||||||
Proceeds
from issuance of preferred stock, net
|
-
|
-
|
16,759,596
|
|||||||
Net
cash provided by financing activities
|
28,992,309
|
34,280,120
|
85,062,032
|
|||||||
Net
increase in cash and cash equivalents
|
14,083,174
|
24,081,513
|
40,938,624
|
|||||||
Cash
and cash equivalents, beginning of period
|
26,855,450
|
8,880,717
|
-
|
|||||||
Cash
and cash equivalents, end of period
|
$
|
40,938,624
|
$
|
32,962,230
|
$
|
40,938,624
|
||||
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 private
placement
|
$
|
5,432,793
|
$
|
13,092,561
|
$
|
18,525,354
|
||||
Warrants
issued to placement agent, in connection with
preferred stock issuance
|
$
|
-
|
$
|
-
|
$
|
1,682,863
|
||||
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
|
||||||||||||||||||||||||||||
Series
A
Convertible Preferred Stock |
Series A Convertible
Preferred Stock |
Common Stock
|
Additional Paid- |
Deficit Accumulated
During The |
Total
Stockholders' Equity/ |
|||||||||||||||||||||||
Shares
|
Amount
|
Warrants
|
Shares
|
Amount
|
in Capital
|
Warrants
|
Development 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
|
-
|
-
|
-
|
-
|
-
|
1,079,048
|
-
|
-
|
1,079,048
|
|||||||||||||||||||
Issuance
of common stock due to exercise of stock options
|
-
|
-
|
-
|
37,666
|
38
|
21,356
|
-
|
-
|
21,394
|
|||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(18,909,253
|
)
|
(18,909,253
|
)
|
|||||||||||||||||
Balance
at September 30, 2007 (unaudited)
|
-
|
$
|
-
|
$
|
-
|
21,220,614
|
$
|
21,221
|
$
|
69,300,494
|
$
|
20,503,894
|
$
|
(52,130,528
|
)
|
$
|
37,695,081
|
1.
|
BASIS
OF PRESENTATION AND
OPERATIONS
|
1.
|
BASIS
OF PRESENTATION AND OPERATIONS
…CONTINUED
|
2.
|
RECENT
ACCOUNTING PRONOUNCEMENTS
|
3.
|
STOCK-BASED
COMPENSATION
|
|
Three months
|
Three months
|
Nine months
|
Nine months
|
|||||||||
|
ended September 30, 2007
|
ended September 30, 2006
|
ended September 30, 2007
|
ended September 30, 2006
|
|||||||||
|
|
|
|
|
|||||||||
Research
and development, including costs of research contracts
|
$
|
139,696
|
$
|
101,928
|
$
|
511,954
|
$
|
266,172
|
|||||
General
and administrative
|
203,601
|
228,535
|
567,094
|
2,158,014
|
|||||||||
Share
based compensation expense before tax
|
343,297
|
330,463
|
1,079,048
|
2,424,186
|
|||||||||
Income
tax benefit
|
-
|
-
|
-
|
-
|
|||||||||
Net
compensation expense
|
$
|
343,297
|
$
|
330,463
|
$
|
1,079,048
|
$
|
2,424,186
|
4.
|
STOCKHOLDERS’
EQUITY
|
5.
|
RELATED
PARTY TRANSACTIONS
|
6.
|
STOCK
OPTION PLAN
|
6.
|
STOCK
OPTION PLAN ...CONTINUED
|
Number of
Shares |
Weighted
Average
Exercise Price |
Weighted
Average
Remaining
Contractual Term (Years) |
Aggregate
Intrinsic Value |
||||||||||
Outstanding,
January 1, 2007
|
1,913,035
|
$
|
3.95
|
||||||||||
Granted
|
454,750
|
4.87
|
|||||||||||
Exercised
|
12,555
|
1.70
|
|||||||||||
Cancelled
|
129,181
|
3.93
|
|||||||||||
Outstanding,
September 30, 2007
|
2,226,049
|
$
|
4.14
|
8.32
|
$
|
1,121,093
|
|||||||
Options
exercisable, September 30, 2007
|
1,340,032
|
$
|
3.42
|
7.67
|
$
|
1,116,640
|
|||||||
Outstanding,
September 30, 2006
|
1,656,630
|
$
|
3.56
|
8.76
|
$
|
2,679,983
|
|||||||
Options
exercisable, September 30, 2006
|
942,097
|
$
|
3.43
|
8.68
|
$
|
1,622,360
|
7.
|
WARRANTS
|
|
·
|
Darinaparsin
(ZIO-101) is an organic arsenic compound covered by issued patents
and pending patent applications in the U.S. and foreign countries.
A form
of commercially available inorganic arsenic (arsenic trioxide (Trisenox
®
)
or ATO) has been approved for the treatment of acute promyelocytic
leukemia (APL), a precancerous condition, and is on the compendia
listing
for the therapy of multiple myeloma as well as having been studied
for the
treatment of various other cancers. Nevertheless, ATO has been
shown to be
toxic to the heart, liver, and brain, limiting 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 generally is 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 species. 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 antiangiogenic
properties of darinaparsin and also support the development of
an oral
form of the drug.
|
|
|
Phase
I testing of the intravenous (IV) form of darinaparsin in both
solid
tumors and hematological cancers is completed. The Company has
reported
encouraging signs of clinical activity along with an expected safety
profile in both of these studies. The Company is presently conducting
phase II studies in advanced myeloma, certain other hematological
cancers,
and primary liver cancer and has reported on early patient treatment
in
both of the blood cancer trials. The Company has recently opened
a phase I
study for an oral form of darinaparsin ahead of schedule. Study
results
from the oral phase I trial and the ongoing phase II trials, in
conjunction with the changing marketplace with regard to other
therapies,
will determine the expected registration pathway for
darinaparsin.
|
|
|
|
|
·
|
ZIO-201,
or isophosphoramide mustard (IPM), is a proprietary stabilized
metabolite
of ifosfamide that is also related to cyclophosphamide. A patent
application for pharmaceutical composition has been filed in the
U.S. and
internationally. Cyclophosphamide and ifosfamide are alkylating
agents.
The Company believes cyclophosphamide is the most widely used alkylating
agent in cancer therapy and it is used to treat breast cancer and
non-Hodgkin’s lymphoma. Ifosfamide has been shown to be effective in high
dose by itself or in combination in treating sarcoma and lymphoma
and is
approved by the FDA 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. Food and Drug Administration.
Our
preclinical studies have shown that, in animal and laboratory models,
IPM
evidences activity against leukemia and solid tumors. These studies
also
indicate that ZIO-201 has a better pharmacokinetic and safety profile
than
ifosfamide or cyclophosphamide, offering the possibility of safer
and more
efficacious therapy with ZIO-201. Ifosfamide is metabolized to
IPM. In
addition to IPM, another metabolite of ifosfamide is 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 another metabolite of ifosfamide
and
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 ZIO-201 is independently
active
without acrolein or chloroacetaldehyde metabolites, the Company
believes
that the administration of ZIO-201 (and without the co-administration
of
mesna) may avoid many of the toxicities of ifosfamide and cyclophosphamide
without compromising efficacy. In some instances ZIO-201 appears
to show
activity in ifosfamide- and/or cyclophosphamide-resistant cancer
cells.
|
|
|
|
|
|
Phase
I and phase II testing of the intravenous (“IV”) form of ZIO-201 to treat
advanced sarcoma is ongoing in the U.S. IPM 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
encouraging signs of clinical activity in the phase II study to
date which
is now nearing completion. The Company expects this phase II study,
following discussions with appropriate health authorities, will
serve as a
basis for a registration trial. The Company also expects to file
a U.S.
Investigational New Drug Application for an oral form of ZIO-201
by the
end of 2007, and to initiate a phase I trial in pediatric cancer
and other
solid tumors by the end of Q1
2008.
|
|
·
|
Indibulin
(ZIO-301) is a novel small molecular weight tubulin polymerization
inhibitor that has been acquired from Baxter Healthcare. An ongoing
phase
I study in the Netherlands and a recently initiated phase I study in
the U.S. (with continuous dosing) are currently underway to evaluate
safety, pharmacokinetics (PK), maximum tolerated dose (MTD) and
dose
limiting toxicity (DLT) in patients with advanced solid tumors.
The
Company expects to complete these and other studies as the basis
for a
phase II study for a solid tumor as well as a phase Ib combination
study
with another agent (as determined by ongoing preclinical evaluation)
in
the first half of 2008.
The
microtubule component tubulin is one of the best established
anti-tumor
targets in the treatment of cancer today. A number of anticancer
drugs are
on the market that target tubulin, for example paclitaxel (Taxol
®
)
and the vinca alkaloid family (vincristine, vinorelbine). 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
associated with important toxicities, notably significant peripheral
neurotoxicity. In contrast, indibulin has not shown peripheral
neurotoxicity either in preclinical testing or in clinical studies
to
date.
Indibulin
is an orally available compound. Preclinical studies demonstrate
significant and broad activity (including in taxane refractory
and
multi-drug resistant cell lines and xenografts) and it is potentially
safer than other tubulin inhibitors (no neurotoxicity at curative
doses in
animals and in the ongoing phase I trials). At the current time,
the
Company anticipates pursuing a Fast Track development program
in a niche
indication following the completion of phase II testing. In addition,
the
availability of an IV formulation would further expand the market
opportunity and will be explored in 2008. The availability of
an oral
formulation of indibulin creates significant commercial opportunity,
since
no oral formulations of paclitaxel or related compounds are currently
on
the market.
|
·
|
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, ZIO-201 and indibulin, and
preclinical costs associated with back-up candidates;
|
|
|
·
|
Costs
related to the scale-up and manufacture of darinaparsin, ZIO-201
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
|
Less than 1
Year |
2 Years
|
3 Years
|
4 Years
|
5 Years
|
|||||||||||||
Operating
lease
|
$
|
1,683,588
|
$
|
502,044
|
$
|
472,150
|
$
|
362,331
|
$
|
186,750
|
$
|
160,313
|
Exhibit
No.
|
|
Description
|
31.1
|
|
Certification
of Chief Executive Officer
|
31.2
|
|
Certification
of Chief Financial Officer
|
32.1
|
|
Certification
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
|
32.2
|
|
Certification
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
|
|
ZIOPHARM
ONCOLOGY, INC.
|
|
|
|
|
Date: November
2, 2007
|
By:
|
/s/ Jonathan
Lewis
|
Jonathan
Lewis, M.D., Ph.D.
Chief
Executive Officer
(Principal
Executive Officer)
|
||
Date:
November 2, 2007
|
By:
|
/s/ Richard
Bagley
|
Richard
Bagley
Chief
Financial Officer
(Principal
Financial and Accounting
Officer)
|
Exhibit
No.
|
|
Description
|
|
|
|
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.
|
Date:
November 2, 2007
|
|
|
|
/s/
Jonathan
Lewis
|
|
Jonathan Lewis, M.D., Ph.D. | |
Principal
Executive Officer
|
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 small business issuer,
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)
|
Evaluated
the effectiveness of the small business issuer’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
|
c)
|
Disclosed
in this report any change in the small business issuer’s internal control
over financial reporting that occurred during the small business
issuer’s
most recent fiscal quarter (the small business issuer’s fourth fiscal
quarter in the case of an annual report) that has materially affected,
or
is reasonably likely to materially affect, the small business issuer’s
internal control over financial reporting;
and
|
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 small business issuer’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 small business issuer’s
internal control over financial
reporting.
|
Date:
November 2, 2007
|
|
|
|
/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 November
2, 2007
|
|
(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 November
2, 2007
|