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 March 31, 2006 (unaudited) and December 31, 2005
|
3
|
|||
Statement
of Operations for the three months ended March 31, 2006 and 2005
(unaudited) and for the period from inception (September
9, 2003) to March
31, 2006 (unaudited)
|
4
|
|||
Statement
of Cash Flows for the three months ended March 31, 2006 and 2005
(unaudited) and for the period from inception (September 9, 2003)
to March
31, 2006 (unaudited)
|
5
|
|||
Statement
of Changes in Convertible Preferred Stock and Stockholders’
Equity/(Deficit) for the three months ended March 31, 2006 (unaudited)
and
for the year ended December 31, 2005 and 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
|
17
|
||
Item
3.
|
Controls
and Procedures
|
25
|
||
PART
II
|
OTHER
INFORMATION
|
|||
Item
1.
|
Legal
Proceedings
|
26
|
||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
26
|
||
Item
3.
|
Defaults
Under Senior Securities
|
26
|
||
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
26
|
||
Item
5.
|
Other
Information
|
26
|
||
Item
6.
|
Exhibits
|
27
|
||
Signatures
|
28
|
|||
Exhibit
Index
|
29
|
|
March
31, 2006
|
|
December
31, 2005
|
||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
1,079,203
|
$
|
8,880,717
|
|||
Short-term
investments
|
4,500,000
|
-
|
|||||
Prepaid
expenses and other current assets
|
296,132
|
211,837
|
|||||
Total
current assets
|
5,875,335
|
9,092,554
|
|||||
Property
and equipment, net
|
301,770
|
269,702
|
|||||
Deposits
|
5,700
|
5,700
|
|||||
Other
non current assets
|
125,200
|
124,343
|
|||||
Total
assets
|
$
|
6,308,005
|
$
|
9,492,299
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
544,907
|
$
|
835,997
|
|||
Accrued
expenses
|
1,443,077
|
1,418,819
|
|||||
Total
current liabilities
|
1,987,984
|
2,254,816
|
|||||
Deferred
rent
|
36,436
|
35,557
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders'
equity:
|
|||||||
Common
stock, $.001 par value; 280,000,000 shares
authorized;
|
|||||||
7,272,992
and 7,247,992 shares issued and outstanding
|
|||||||
at
March 31, 2006 and December 31, 2005, respectively
|
7,273
|
7,248
|
|||||
Additional
paid-in capital
|
22,859,708
|
22,559,034
|
|||||
Deficit
accumulated during the development stage
|
(18,583,396
|
)
|
(15,364,356
|
)
|
|||
Total
stockholders' equity
|
4,283,585
|
7,201,926
|
|||||
Total
liabilities and stockholders' equity
|
$
|
6,308,005
|
$
|
9,492,299
|
For
the three
Months
Ended
March
31, 2006
|
For
the three
Months
Ended
March
31, 2005
|
For
the Period
from
Inception
(September
9, 2003)
Through
March
31, 2006
|
||||||||
(unaudited)
|
(unaudited)
|
(unaudited)
|
||||||||
Research
contract revenue
|
$
|
-
|
$
|
-
|
$
|
-
|
||||
Operating
expenses and other income:
|
||||||||||
Research
and development, including
|
||||||||||
costs
of research contracts
|
1,768,250
|
1,598,571
|
9,488,707
|
|||||||
General
and administrative
|
1,504,628
|
665,857
|
9,440,774
|
|||||||
Total
operating expenses
|
3,272,878
|
2,264,428
|
18,929,481
|
|||||||
Loss
from operations
|
(3,272,878
|
)
|
(2,264,428
|
)
|
(18,929,481
|
)
|
||||
Interest
income
|
53,838
|
3,873
|
346,085
|
|||||||
Net
loss
|
$
|
(3,219,040
|
)
|
$
|
(2,260,555
|
)
|
$
|
(18,583,396
|
)
|
|
Basic
and diluted net loss per share
|
$
|
(0.44
|
)
|
$
|
(0.82
|
)
|
||||
Weighted
average common shares outstanding used to compute
|
||||||||||
basic
and diluted net loss per share
|
7,269,501
|
2,761,621
|
For
the three months |
|
For
the three months |
|
For
the
Period from
Inception |
||||||
Cash
flows from operating activities:
|
||||||||||
Net
loss
|
$
|
(3,219,040
|
)
|
$
|
(2,260,555
|
)
|
$
|
(18,583,396
|
)
|
|
Adjustments
to reconcile net loss to net cash used
in operating activities:
|
||||||||||
Depreciation
and amortization
|
36,631
|
23,001
|
171,816
|
|||||||
Non-cash
stock-based compensation
|
300,674
|
-
|
1,102,545
|
|||||||
Loss
on disposal of fixed assets
|
1,166
|
- | 1,166 | |||||||
Change
in operating assets and liabilities:
|
||||||||||
(Increase)
decrease in:
|
||||||||||
Prepaid
expenses and other current assets
|
(84,295
|
)
|
25,872
|
(296,132
|
)
|
|||||
Other
noncurrent assets
|
(857
|
)
|
4,014
|
(125,200
|
)
|
|||||
Deposits
|
-
|
-
|
(5,700
|
)
|
||||||
Increase
(decrease) in:
|
||||||||||
Accounts
payable
|
(291,090
|
)
|
1,091,507
|
544,907
|
||||||
Accrued
expenses
|
24,258
|
228,091
|
1,443,077
|
|||||||
Deferred
rent
|
879
|
-
|
36,436
|
|||||||
Net
cash used in operating activates
|
(3,231,674
|
)
|
(888,070
|
)
|
(15,710,481
|
)
|
||||
Cash
flows from investing activities:
|
||||||||||
Purchases
of property and equipment
|
(69,865
|
)
|
(1,298
|
)
|
(474,752
|
)
|
||||
Increase
in short-term investments
|
(4,500,000
|
)
|
-
|
(4,500,000
|
)
|
|||||
Net
cash used in investing activities
|
(4,569,865
|
)
|
(1,298
|
)
|
(4,974,752
|
)
|
||||
Cash
flows from financing activities:
|
||||||||||
Stockholders'
capital contribution
|
-
|
-
|
500,000
|
|||||||
Proceeds
from issuance of common stock, net
|
-
|
-
|
4,504,815
|
|||||||
Issuance
of common stock for services rendered
|
25
|
-
|
25
|
|||||||
Proceeds
from issuance of preferred stock, net
|
-
|
-
|
16,759,596
|
|||||||
Net
cash provided by financing activities
|
25
|
-
|
21,764,436
|
|||||||
Net
increase (decrease) in cash and cash equivalents
|
(7,801,514
|
)
|
(889,368
|
)
|
1,079,203
|
|||||
Cash
and cash equivalents, beginning of period
|
8,880,717
|
1,026,656
|
-
|
|||||||
Cash
and cash equivalents, end of period
|
$
|
1,079,203
|
$
|
137,288
|
$
|
1,079,203
|
||||
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 agent, in connection with preferred
stock issuance
|
$
|
-
|
$
|
-
|
$
|
1,682,863
|
Convertible
Preferred Stock and
Warrants
|
|
Stockholder's
Equity (Deficit)
|
|
||||||||||||||||||||||
|
|
Series
A
Convertible |
|
Warrants
to
Purchase Series A Convertible Preferred Stock |
|
Common
Stock
|
|
Additional
Paid-in |
|
DeficitAccumulated during
the |
|
Total Stockholders
'Equity/ |
|
||||||||||||
|
|
Shares
|
|
Amount
|
|
Warrants
|
|
Shares
|
|
Amount
|
|
Capital
|
|
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 (audited)
|
-
|
-
|
-
|
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
|
-
|
-
|
-
|
-
|
-
|
264,277
|
-
|
264,277
|
|||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(5,687,297
|
)
|
(5,687,297
|
)
|
|||||||||||||||
Balance
at December 31, 2004 (audited)
|
-
|
-
|
-
|
2,761,625
|
2,761
|
5,700,355
|
(5,847,433
|
)
|
(144,317
|
)
|
|||||||||||||||
Issuance
of Series A convertible preferred stock
|
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
|
16,755,398
|
-
|
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
|
98,755
|
98,755
|
|||||||||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(9,516,923
|
)
|
(9,516,923
|
)
|
|||||||||||||||
Balance
at December 31, 2005 (audited)
|
-
|
-
|
-
|
7,247,992
|
7,248
|
22,559,034
|
(15,364,356
|
)
|
7,201,926
|
||||||||||||||||
Issuance
of common stock for services rendered
|
-
|
-
|
-
|
25,000
|
25
|
106,225
|
-
|
106,250
|
|||||||||||||||||
Stock
based compensation for employees
|
-
|
-
|
-
|
-
|
-
|
194,449
|
-
|
194,449
|
|||||||||||||||||
Net
loss
|
-
|
-
|
-
|
-
|
-
|
-
|
(3,219,040
|
)
|
(3,219,040
|
)
|
|||||||||||||||
Balance
at March 31, 2006 (unaudited)
|
-
|
-
|
-
|
7,272,992
|
$
|
7,273
|
$
|
22,859,708
|
$
|
(18,583,396
|
)
|
$
|
4,283,585
|
1.
|
BASIS
OF PRESENTATION AND
OPERATIONS
|
2.
|
STOCK
BASED COMPENSATION
|
Three
months ended March 31,
|
||||
2006
|
||||
Research
and development, including costs of research contracts
|
$
|
27,991
|
||
General
and administrative
|
166,458
|
|||
Share
based compensation expense before tax
|
194,449
|
|||
Income
tax benefit
|
-
|
|||
Net
compensation expense
|
$
|
194,449
|
Three
months ended March 31,
|
||||
2005
|
||||
Net
loss:
|
||||
As
reported
|
$
|
(2,260,555
|
)
|
|
Stock-based
compensation expense included in reported net loss
|
-
|
|||
Stock-based
compensation expense under the fair value-based method
|
(233,785
|
)
|
||
Pro
forma net loss
|
$
|
(2,494,340
|
)
|
|
Basic
and diluted net loss per share:
|
||||
As
reported
|
$
|
(0.82
|
)
|
|
Pro
forma
|
$
|
(0.90
|
)
|
3.
|
CONVERTIBLE
PREFERRED STOCK AND STOCKHOLDERS’
EQUITY
|
4.
|
RELATED
PARTY TRANSACTIONS
|
5.
|
STOCK
OPTION PLAN
|
|
|
Weighted
|
Weighted
Average
|
||||||||||
|
|
Average
|
Remaining
|
||||||||||
|
Number
of
|
Exercise
|
Contractual
|
Aggregate
|
|||||||||
|
Shares
|
Price
|
Term
(Years)
|
Intrinsic
Value
|
|||||||||
Outstanding,
January 1, 2006
|
973,639
|
$
|
2.56
|
||||||||||
Granted
|
—
|
—
|
|||||||||||
Exercised
|
—
|
—
|
|||||||||||
Canceled
|
—
|
—
|
|||||||||||
Outstanding,
March 31, 2006
|
973,639
|
$
|
2.56
|
8.7
|
2,200,200
|
||||||||
Options
exercisable, March 31, 2006
|
417,423
|
$
|
1.97
|
8.4
|
1,180,876
|
Name
|
Title
|
No.
of Options
|
Vesting
|
|||
Jonathan
Lewis
|
Chief
Executive Officer
|
214,315
|
100%
upon date of grant
|
|||
Richard
E. Bagley
|
President,
Chief Operating Officer, Treasurer and Chief Financial
Officer
|
54,873
|
100%
upon date of grant
|
|||
Robert
Newman
|
Vice
President Business Operations (non-officer)
|
40,000
|
50%
upon date of grant and 50% on December 14, 2006
|
|||
Robert
Peter Gale
|
Senior
Vice President Research
|
25,000
|
50%
upon date of grant and 50% on December 14,
2006
|
6.
|
WARRANTS
|
7.
|
SUBSEQUENT
EVENT
|
·
|
ZIO-101
is an organic arsenic compound covered by issued U.S. patents and
applications internationally. 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 phase I clinical studies to date
have
demonstrated that ZIO-101 (and organic arsenic in general) is considerably
less toxic than inorganic arsenic, particularly with regard to heart
toxicity. In vitro testing of ZIO-101 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.
|
·
|
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.
Cyclophosphamide and ifosfamide are alkylating agents. The Company
believes cyclophosphamide is the most widely used alkylating agent
in
cancer therapy and 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. Although
ifosfamide-based treatment generally represents the standard of care
for
sarcoma, it is not licensed for this indication by the FDA. 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 may avoid many of the toxicities
of
ifosfamide and cyclophosphamide without compromising efficacy. In
addition
to anticipated lower toxicity, ZIO-201 (and without the co-administration
of mesna) may have other advantages over ifosfamide. In preclinical
studies ZIO-201 likely cross-links DNA differently than ifosfamide
or
cyclophosphamide metabolites, resulting in a different activity profile.
Moreover, in some instances ZIO-201 appears to show activity in
ifosfamide- and/or cyclophosphamide-resistant cancer
cells.
|
· |
Fees
and milestone payments required under the license agreements relating
to
our existing product candidates and additional in-licensed candidates;
|
· |
Clinical
trial expenses, including the costs incurred with respect to the
conduct
of clinical trials for ZIO-101 and ZIO-201 and preclinical costs
associated with back-up candidates ZIO-102 and ZIO-202;
|
· |
Costs
related to the scale-up and manufacture of ZIO-101 and
ZIO-201;
|
· |
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 product
candidates;
|
· |
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
|
1
- 3 Years
|
4
- 5 Years
|
After
5 Years
|
||||||||||||
Operating
lease
|
$
|
796,241
|
$
|
190,457
|
$
|
399,400
|
$
|
206,384
|
$
|
–
|
Exhibit
No.
|
Description
|
|
31.1
|
Certification
of Chief Executive Officer
|
|
31.2
|
Certification
of Chief Financial Officer
|
|
32.1
|
Certifications
of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
|
|
32.2
|
Certifications
of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.
|
ZIOPHARM ONCOLOGY, INC. | ||
|
|
|
Date: May 15, 2006 | By: | /s/ Jonathan Lewis |
Jonathan
Lewis
Chief
Executive Officer
(Principal
Executive Officer)
|
||
|
|
|
Date: May 15, 2006 | 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.
|