10QSB: Optional form for quarterly and transition reports of small business issuers
Published on August 14, 2007
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-QSB
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
|
|
For
the quarterly period ended June
30, 2007
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|
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|
o
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Commission
file number: 000-51476
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LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
|
(Exact
name of small business issuer as specified in its
charter)
|
Delaware
|
20-2903526
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
Employer
Identification
Number)
|
|
|
248
Route 25A, No. 2
East
Setauket, New York 11733
|
|
(Address
of principal executive offices)
(631)
942-7959
|
|
(Issuer’
s telephone number, including area
code)
|
Not
applicable
(Former
name, former address and former fiscal year, if changed since last
report)
Indicate
by check mark whether the issuer (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes x
No
o
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o
No
x
As
of
July 31, 2007, the Company had 26,582,183 shares of common stock, $0.0001 par
value, issued and outstanding.
Transitional
Small Business Disclosure Format: Yes o
No
x
Documents
incorporated by reference: None
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(FORMERLY
SRKP 7, INC.)
INDEX
|
Page
No.
|
PART
I - FINANCIAL INFORMATION
|
|
|
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Item
1. Financial Statements
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|
|
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Condensed
Consolidated Balance Sheets -
|
|
|
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June
30, 2007 (Unaudited) and December 31, 2006 (Restated)
|
1
|
|
|
Condensed
Consolidated Statements of Operations (Unaudited) -
|
|
|
|
Three
Months Ended June 30, 2007 and 2006, Six Months Ended June 30, 2007
and
2006,
and
August 9, 2005 (Inception) to June 30, 2007 (Cumulative)
|
2
|
|
|
Condensed
Consolidated Statement of Changes in Stockholders’ Equity (Deficiency)
(Unaudited) -
|
|
|
|
August 9,
2005 (Inception) to June 30, 2007
|
3
|
|
|
Condensed
Consolidated Statements of Cash Flows (Unaudited) -
|
|
|
|
Six
Months Ended June 30, 2007 and 2006, and August 9, 2005 (Inception)
to June 30, 2007 (Cumulative)
|
4-5
|
|
|
Notes
to Condensed Consolidated Financial Statements -
|
|
|
|
June
30, 2007 (Unaudited) and December 31, 2006 (Restated)
|
6
|
|
|
Item
2. Management’s Discussion and Analysis or Plan of
Operation
|
13
|
|
|
Item
3. Controls and Procedures
|
21
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PART
II - OTHER INFORMATION
|
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||
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Item
1
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|
Legal
Proceedings
|
22
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|
|
|
|
Item
2
|
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Unregistered
Sales of Equity Securities and Use of Proceeds
|
22
|
|
|
|
|
Item
3
|
|
Defaults
Upon Senior Securities
|
22
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|
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Item
4
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Submission
of Matters to a Vote of Security Holders
|
22
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Item
5
|
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Other
Information
|
22
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Item
6
|
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Exhibits
|
22
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SIGNATURES
|
|
24
|
This
Quarterly Report on Form 10-QSB contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, and Section
21E
of the Securities Exchange Act of 1934. For example, statements regarding the
Company’s financial position, business strategy and other plans and objectives
for future operations, and assumptions and predictions about future product
demand, supply, manufacturing, costs, marketing and pricing factors are all
forward-looking statements. These statements are generally accompanied by words
such as “intend,” anticipate,” “believe,” “estimate,” “potential(ly),”
“continue,” “forecast,” “predict,” “plan,” “may,” “will,” “could,” “would,”
“should,” “expect” or the negative of such terms or other comparable
terminology. The Company believes that the assumptions and expectations
reflected in such forward-looking statements are reasonable, based on
information available to it on the date hereof, but the Company cannot provide
assurances that these assumptions and expectations will prove to have been
correct or that the Company will take any action that the Company may presently
be planning. However, these forward-looking statements are inherently subject
to
known and unknown risks and uncertainties. Actual results or experience may
differ materially from those expected or anticipated in the forward-looking
statements. Factors that could cause or contribute to such differences include,
but are not limited to, regulatory policies, available cash, research results,
competition from other similar businesses, and market and general economic
factors. This discussion should be read in conjunction with the condensed
consolidated financial statements and notes thereto included in Item 1 of
this Quarterly Report on Form 10-QSB.
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
June
30,
2007
(Unaudited)
|
December
31,
2006
(Restated)
|
|||||
ASSETS
|
|
|
|||||
Current
assets:
|
|
|
|||||
Cash
and cash equivalents
|
$
|
194,671
|
$
|
679,640
|
|||
Advances
on research and development contract services
|
174,925
|
50,000
|
|||||
Prepaid
insurance
|
5,990
|
20,365
|
|||||
Total
current assets
|
375,586
|
750,005
|
|||||
Office
equipment ,
net of accumulated depreciation of $871 at June 30, 2007
and $575 at December 31, 2006 |
1,038
|
1,062
|
|||||
Total
assets
|
$
|
376,624
|
$
|
751,067
|
|||
|
|||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
11,587
|
$
|
31,786
|
|||
Liquidated
damages payable under registration rights agreement
|
74,000
|
74,000
|
|||||
Research
and development contract liabilities
|
25,873
|
---
|
|||||
Due
to stockholder
|
92,717
|
92,717
|
|||||
Total
current liabilities
|
204,177
|
198,503
|
|||||
|
|||||||
Commitments
and contingencies
|
|||||||
|
|||||||
Stockholders’
equity:
|
|||||||
Preferred
stock, $0.0001 par value;
authorized
- 10,000,000 shares; issued - none
|
—
|
—
|
|||||
Common
stock, $0.0001 par value;
authorized
- 100,000,000 shares; issued and outstanding - 26,582,183
shares
|
2,658
|
2,658
|
|||||
Additional
paid-in capital
|
1,176,822
|
1,128,114
|
|||||
Deficit
accumulated during the development stage
|
(1,007,033
|
)
|
(578,208
|
)
|
|||
Total
stockholders’ equity
|
172,447
|
552,564
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
376,624
|
$
|
751,067
|
See
accompanying notes to condensed consolidated financial
statements.
1
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
Three
Months Ended
June 30, |
Six
Months Ended
June 30,
|
Period from
August 9,
2005
(Inception)
to
June 30,
2007
|
||||||||||||||
2007
|
2006
|
2007
|
2006
|
(Cumulative)
|
||||||||||||
Revenues
|
$
|
---
|
$
|
---
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||
|
||||||||||||||||
Costs
and expenses:
|
||||||||||||||||
General
and administrative, including $8,792 and $79,566 of stock-based
compensation during the three months ended June 30, 2007 and 2006,
$17,708
and $79,566 during the six months ended June 30, 2007 and 2006,
respectively, and $115,108 for the period from August 9, 2005 (inception)
to June 30, 2007 (cumulative)
|
104,233
|
113,869
|
255,986
|
135,853
|
571,417
|
|||||||||||
Depreciation
|
148
|
114
|
296
|
229
|
871
|
|||||||||||
Research
and development costs, including $31,000 of stock-based expense during
the
six months ended June 30, 2007 and the period from August 9, 2005
inception) to June 30, 2007 (cumulative)
|
74,925
|
50,000
|
180,850
|
50,000
|
330,950
|
|||||||||||
Reverse
merger costs
|
---
|
45,000
|
---
|
50,000
|
50,000
|
|||||||||||
Total
costs and expenses
|
179,306
|
208,983
|
437,132
|
236,082
|
953,238
|
|||||||||||
|
(179,306
|
)
|
(208,983
|
)
|
(437,132
|
)
|
(236,082
|
)
|
(953,238
|
)
|
||||||
Interest
income
|
3,584
|
---
|
8,307
|
—
|
20,205
|
|||||||||||
Liquidated
damages under registration rights agreement
|
---
|
---
|
---
|
—
|
(74,000
|
)
|
||||||||||
Net
loss
|
$
|
(175,722
|
)
|
$
|
(208,983
|
)
|
$
|
(428,825
|
)
|
$
|
(236,082
|
)
|
$
|
(1,007,033
|
)
|
|
Net
loss per common share - basic and diluted
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.02
|
)
|
$
|
(0.01
|
)
|
||||
Weighted
average number of common shares outstanding - basic and
diluted
|
26,582,183
|
19,087,490
|
26,582,183
|
19,054,819
|
See
accompanying notes to condensed consolidated financial
statements.
2
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY
(DEFICIENCY)
Period
from August 9, 2005 (Inception) to June 30, 2007
|
|
|
|
|
||||||||||||
|
Common
Stock
|
Additional
Paid-in
|
Deficit
Accumulated
During
the Development
|
Total
Stockholders’ Equity
|
||||||||||||
|
Shares
|
Amount
|
Capital
|
Stage
|
(Deficiency)
|
|||||||||||
|
|
|
|
|
|
|||||||||||
Balance,
August 9, 2005 (inception)
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
|||||||
Shares
issued to founding stockholder
|
19,021,786
|
1,902
|
(402
|
)
|
—
|
1,500
|
||||||||||
Net
loss
|
—
|
—
|
—
|
(16,124
|
)
|
(16,124
|
)
|
|||||||||
Balance,
December 31, 2005
|
19,021,786
|
1,902
|
(402
|
)
|
(16,124
|
)
|
(14,624
|
)
|
||||||||
Shares
issued in connection with reverse merger
transaction
|
4,005,177
|
401
|
62,099
|
—
|
62,500
|
|||||||||||
Shares
issued in private placement, net of offering
costs of $214,517
|
3,555,220
|
355
|
969,017
|
—
|
969,372
|
|||||||||||
Stock-based
compensation
|
—
|
—
|
97,400
|
—
|
97,400
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
(562,084
|
)
|
(562,084
|
)
|
|||||||||
Balance,
December 31, 2006 (Restated)
|
26,582,183
|
2,658
|
1,128,114
|
(578,208
|
)
|
552,564
|
||||||||||
Stock-based
compensation
|
—
|
—
|
17,708
|
—
|
17,708
|
|||||||||||
Stock-based
research and development costs
|
—
|
—
|
31,000
|
—
|
31,000
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
(428,825
|
)
|
(428,825
|
)
|
|||||||||
Balance,
June 30, 2007 (Unaudited)
|
26,582,183
|
$
|
2,658
|
$
|
1,176,822
|
$
|
(1,007,033
|
)
|
$
|
172,447
|
See
accompanying notes to condensed consolidated financial
statements.
3
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
|
Six
Months Ended
June
30,
|
Period from
August 9,
2005
(Inception)
to
June
30, 2007
|
||||||||
|
2007
|
2006
|
(Cumulative)
|
|||||||
|
|
|
|
|||||||
Cash
flows from operating activities
|
|
|
|
|||||||
Net
loss
|
$
|
(428,825
|
)
|
$
|
(236,082
|
)
|
$
|
(1,007,033
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Depreciation
|
296
|
229
|
871
|
|||||||
Stock-based
compensation
|
17,708
|
79,566
|
115,108
|
|||||||
Stock-based
research and development costs
|
31,000
|
---
|
31,000
|
|||||||
Changes
in operating assets and liabilities:
|
||||||||||
(Increase)
decrease in -
|
||||||||||
Advances
on research and development contract services
|
(124,925
|
)
|
(150,000
|
)
|
(174,925
|
)
|
||||
Prepaid
expenses
|
14,375
|
---
|
(5,990
|
)
|
||||||
Increase
(decrease) in -
|
||||||||||
Accounts
payable and accrued expenses
|
(20,199
|
)
|
15,958
|
11,587
|
||||||
Research
and development contract liabilities
|
25,873
|
197,000
|
25,873
|
|||||||
Liquidated
damages payable under registration rights agreement
|
---
|
---
|
74,000
|
|||||||
Net
cash used in operating activities
|
(484,697
|
)
|
(93,329
|
)
|
(929,509
|
)
|
||||
|
||||||||||
Cash
flows from investing activities
|
||||||||||
Purchase
of office equipment
|
(272
|
)
|
(237
|
)
|
(1,909
|
)
|
||||
Net
cash used in investing activities
|
(272
|
)
|
(237
|
)
|
(1,909
|
)
|
||||
|
||||||||||
Cash
flows from financing activities
|
||||||||||
Proceeds
from sale of common stock to founder
|
---
|
---
|
1,500
|
|||||||
Cash
acquired in reverse merger transaction
|
---
|
62,500
|
62,500
|
|||||||
Gross
proceeds from sale of common stock
|
---
|
657,299
|
1,183,889
|
|||||||
Payment
of private placement offering costs
|
---
|
(134,360
|
)
|
(214,517
|
)
|
|||||
Advances
from stockholder
|
---
|
86,771
|
92,717
|
|||||||
Net
cash provided by financing activities
|
---
|
672,210
|
1,126,089
|
|||||||
|
||||||||||
Net
increase (decrease) in cash
|
(484,969
|
)
|
578,644
|
194,671
|
||||||
Cash
at beginning of period
|
679,640
|
4,946
|
---
|
|||||||
Cash
at end of period
|
$
|
194,671
|
$
|
583,590
|
$
|
194,671
|
(continued)
4
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(continued)
Six
Months Ended
June
30,
|
Period from
August 9,
2005
(Inception)
to
June
30, 2007
|
|||||||||
|
2007
|
2006
|
(Cumulative)
|
|||||||
|
|
|
|
|||||||
Supplemental
disclosures of cash flow information:
|
|
|
|
|||||||
Cash
paid for -
|
|
|
|
|||||||
Interest
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
Income
taxes
|
$
|
—
|
$
|
—
|
$
|
—
|
See
accompanying notes to condensed consolidated financial
statements.
5
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
June
30, 2007 (Unaudited) and December 31, 2006 (Restated)
1.
Organization and Basis of Presentation
On
June
30, 2006, Lixte Biotechnology, Inc., a privately-held Delaware corporation
(“Lixte”), completed a reverse merger transaction with SRKP 7, Inc. (“SRKP”), a
public “shell” company, whereby Lixte became a wholly-owned subsidiary of SRKP.
For financial reporting purposes, Lixte was considered the accounting acquirer
in the merger and the merger was accounted for as a reverse merger. Accordingly,
the historical financial statements presented herein are those of Lixte and
do
not include the historical financial results of SRKP. The stockholders’ equity
section of SRKP has been retroactively restated for all periods presented to
reflect the accounting effect of the reverse merger transaction. All costs
associated with the reverse merger transaction were expensed as incurred.
Comparative financial statements for the periods ended June 30, 2006 reflect
the
results of operations of Lixte, the accounting acquirer in the reverse merger
transaction. Unless the context indicates otherwise, SRKP and Lixte are
hereinafter referred to as the “Company”. On December 7, 2006, the Company
amended its Certificate of Incorporation to change its name from SRKP 7, Inc.
to
Lixte Biotechnology Holdings, Inc. (“Holdings”).
The
accompanying condensed consolidated financial statements include the financial
statements of Holdings and its wholly-owned subsidiary, Lixte. All intercompany
balances and transactions have been eliminated in consolidation.
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities at the date of the financial statements and the reported amounts
of
expenses during the reporting period. Actual results could differ from those
estimates.
The
condensed consolidated financial statements of Lixte (the “Company”) at June 30,
2007, for the three months and six months ended June 30, 2007 and 2006, and
for
the period from August 9, 2005 (Inception) to June 30, 2007 (cumulative),
are unaudited. In the opinion of management, all adjustments (including normal
recurring adjustments) have been made that are necessary to present fairly
the
financial position of the Company as of June 30, 2007 and the results of its
operations for the three months and six months ended June 30, 2007 and 2006,
and
for the period from August 9, 2005 (Inception) to June 30, 2007
(cumulative), and its cash flows for the six months ended June 30, 2007 and
2006, and for the period from August 9, 2005 (Inception) to June 30, 2007
(cumulative). Operating results for the interim periods presented are not
necessarily indicative of the results to be expected for a full fiscal year.
The
condensed consolidated balance sheet at December 31, 2006 (Restated) has been
derived from the Company’s audited financial statements (as restated) as of that
date.
The
statements and related notes have been prepared pursuant to the rules and
regulations of the U.S. Securities and Exchange Commission. Accordingly, certain
information and footnote disclosures normally included in financial statements
prepared in accordance with generally accepted accounting principles have been
omitted pursuant to such rules and regulations. These financial statements
should be read in conjunction with the financial statements and other
information included in the Company’s Annual Report on Form 10-KSB, as amended,
as filed with the U.S. Securities and Exchange Commission on May 17,
2007.
Nature
of Operations
Lixte
was
incorporated in Delaware on August 9, 2005 to capitalize on opportunities to
develop low cost, specific and sensitive tests for the early detection of
cancers to better estimate prognosis, to monitor treatment response, and to
reveal targets for development of more effective treatments.
The
Company’s initial focus is on developing new treatments for the most common and
most aggressive type of primary brain cancer, glioblastoma multiforme (“GBM”).
Lixte entered into a Cooperative Research and Development Agreement (“CRADA”)
with the National Institute of Neurological Diseases and Stroke (“NINDS”) of the
National Institutes of Health (“NIH”) to identify and evaluate drugs that target
a specific biochemical pathway for GBM cell differentiation. The CRADA also
covers research to determine whether expression of a component of this pathway
correlates with prognosis in glioma patients.
The
Company expects that its products will derive directly from its intellectual
property, which will consist of patents that it anticipates will arise out
of
its research activities. These patents are expected to cover biomarkers uniquely
associated with the specific types of cancer, patents on methods to identify
drugs that inhibit growth of specific tumor types, and combinations of drugs
and
other potential therapeutic agents for the treatment of specific
cancers.
6
The
Company is considered a “development stage company” as defined in Statement of
Financial Accounting Standards No. 7, “Accounting and Reporting by Development
Stage Enterprises”, as it had not yet commenced any revenue-generating
operations, did not have any cash flows from operations, and was dependent
on
debt and equity funding to finance its operations. The Company has selected
December 31 as its fiscal year-end.
Going
Concern and Plan of Operations
The
Company’s financial statements have been presented on the basis that it is a
going concern, which contemplates the realization of assets and satisfaction
of
liabilities in the normal course of business. The Company is in the development
stage and has not generated any revenues from operations to date, which raises
substantial doubt about its ability to continue as a going concern.
The
Company’s ability to continue as a going concern is dependent upon its ability
to develop additional sources of capital, and ultimately achieve profitable
operations. The accompanying financial statements do not include any adjustments
that might result from the outcome of these uncertainties.
At
June
30, 2007, the Company had not yet commenced any revenue-generating operations.
All activity through June 30, 2007 related to the Company’s formation, capital
raising efforts and initial research and development activities. As such, the
Company has yet to generate any cash flows from operations, and is essentially
dependent on debt and equity funding from both related and unrelated parties
to
finance its operations. Prior to June 30, 2006, the Company’s cash requirements
were funded by advances from Lixte’s founder. On June 30, 2006, the Company
completed an initial closing of its private placement (see Note 3), selling
1,973,869 shares of common stock at a price of $0.333 per share and receiving
net proceeds of $522,939. On July 27, 2006, the Company completed a second
closing of its private placement, selling 1,581,351 shares of common stock
at a
price of $0.333 per share and receiving net proceeds of $446,433.
The
Company does not currently have sufficient resources to fully fund its planned
operations for the next twelve months. The strain on the Company’s limited cash
resources has been further exacerbated by the registration penalty obligation
of
$74,000 (originally recorded at December 31, 2006 pursuant to EITF 00-19-2),
reflecting the cash amount currently payable to the investors in the private
placement for the registration penalty accrued through mid-May 2007, as
described at Note 3. If the Company does not maintain the effectiveness of
its
registration statement, the Company would be subject to a further registration
penalty at the rate of approximately $12,000 per 30-day period thereafter,
continuing through July 2008. Since the Company only has cash of $194,671 and
working capital of $171,409 (including the effect from the $74,000 registration
penalty obligation referred to above) at June 30, 2007, this short-term cash
obligation and the uncertainty related to it could have a material adverse
impact on the Company’s ability to fund its business plan and conduct
operations.
The
Company does not have sufficient resources to fully develop and commercialize
any products that may arise from its research. Accordingly, the Company will
need to raise additional funds in order to satisfy its future working capital
requirements. Based on the Company’s revised
operating budget, through December 31, 2008, the Company estimates that it
will
require approximately $1,500,000 of additional funding. The Company estimates
that it will require an additional $3,500,000 to fund operations (including
laboratory operations) in 2009 and 2010. The amount and timing of future cash
requirements will depend on market acceptance of the Company’s products, if any,
and the resources that the Company devotes to developing and supporting its
products. The Company anticipates funding these cash requirements from debt
or
equity financings, mergers or acquisitions, and/or via the sale or license
of
certain of its assets.
Current
market conditions present uncertainty as to the Company’s ability to secure
additional funds, as well as its ability to reach profitability. There can
be no
assurances that the Company will be able to secure additional financing, or
obtain favorable terms on such financing if it is available, or as to its
ability to achieve positive cash flow from operations. Continued negative cash
flows and lack of liquidity create significant uncertainty about the Company’s
ability to fully implement its operating plan and the Company may have to reduce
the scope of its planned operations. If cash and cash equivalents are
insufficient to satisfy the Company’s liquidity requirements, the Company would
be required to scale back or discontinue its product development program, or
obtain funds if available through strategic alliances that may require the
Company to relinquish rights to certain of its technologies or discontinue
its
operations.
7
Stock-Based
Compensation
In
December 2004, the Financial Accounting Standards Board ("FASB") issued SFAS
No.
123 (revised 2004), "Share-Based Payment" ("SFAS No. 123R"), a revision to
SFAS
No. 123, "Accounting for Stock-Based Compensation". Effective January 1, 2006,
SFAS No. 123R requires that the Company measure the cost of employee services
received in exchange for equity awards based on the grant date fair value of
the
awards, with the cost to be recognized as compensation expense in the Company’s
financial statements over the vesting period of the awards.
The
Company adopted SFAS No. 123R effective January 1, 2006, and is using the
modified prospective method in which compensation cost is recognized beginning
with the effective date (a) based on the requirements of SFAS No. 123R for
all
share-based payments granted after the effective date and (b) based on the
requirements of SFAS No. 123R for all awards granted to employees prior to
the
effective date of SFAS No. 123R that remain unvested on the effective date.
Accordingly, the Company recognizes compensation cost for equity-based
compensation for all new or modified grants issued after December 31, 2005.
The
Company did not have any modified grants subsequent to December 31,
2005.
Adoption
of New Accounting Policies
In
December 2006, the FASB issued FSP EITF 00-19-2, “Accounting for
Registration Payment Arrangements” (“EITF 00-19-2”), which addresses an issuer’s
accounting for registration payment arrangements. EITF 00-19-2 specifies that
the contingent obligation to make future payments or otherwise transfer
consideration under a registration payment arrangement, whether issued as a
separate agreement or included as a provision of a financial instrument or
other
agreement, should be separately recognized and measured in accordance with
FASB
No. 5, “Accounting for Contingencies”. EITF 00-19-2 further clarifies that a
financial instrument subject to a registration payment arrangement should be
accounted for in accordance with other applicable generally accepted accounting
principles without regard to the contingent obligation to transfer consideration
pursuant to the registration payment arrangement. EITF 00-19-2 is effective
immediately for registration payment arrangements and the financial instruments
subject to those arrangements that are entered into or modified subsequent
to
the date of issuance of EITF 00-19-2. For registration payment arrangements
and
financial instruments subject to those arrangements that were entered into
prior
to the issuance of EITF 00-19-2, EITF 00-19-2 is effective for financial
statements issued for fiscal years beginning after December 15, 2006, and
interim periods within those fiscal years. Early adoption of EITF 00-19-2 for
interim or annual periods for which financial statements or interim reports
have
not been issued is permitted. The Company chose to early adopt EITF 00-19-2
effective December 31, 2006 (see Note 3).
Effective
January 1, 2007, the Company adopted FASB Interpretation No. 48, “Accounting for
Uncertainty in Income Taxes, an interpretation of FASB Statement No. 109,
Accounting for Income Taxes” (“FIN 48”). FIN 48 addresses the determination of
whether tax benefits claimed or expected to be claimed on a tax return should
be
recorded in the financial statements. Under FIN 48, the Company may recognize
the tax benefit from an uncertain tax position only if it is more likely than
not that the tax position will be sustained on examination by the taxing
authorities, based on the technical merits of the position. The tax benefits
recognized in the financial statements from such a position should be measured
based on the largest benefit that has a greater than fifty percent likelihood
of
being realized upon ultimate settlement. FIN 48 also provides guidance on
derecognition, classification, interest and penalties on income taxes,
accounting in interim periods and requires increased disclosures. The adoption
of the provisions of FIN 48 did not have a material effect on the Company’s
financial statements. As of June 30, 2007, no liability for unrecognized tax
benefits was required to be recorded.
The
Company files income tax returns in the U.S. federal jurisdiction and various
states. The Company is subject to U.S. federal or state income tax examinations
by tax authorities for years after 2004.
The
Company’s policy is to record interest and penalties on uncertain tax provisions
as income tax expense. As of June 30, 2007, the Company has no accrued interest
or penalties related to uncertain tax positions.
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No.
157, “Fair Value Measurements” (“SFAS No. 157”), which establishes a formal
framework for measuring fair value under generally accepted accounting
principles. SFAS No. 157 defines and codifies the many definitions of fair
value
included among various other authoritative literature, clarifies and, in some
instances, expands on the guidance for implementing fair value measurements,
and
increases the level of disclosure required for fair value measurements. Although
SFAS No. 157 applies to and amends the provisions of existing FASB and AICPA
pronouncements, it does not, of itself, require any new fair value measurements,
nor does it establish valuation standards. SFAS No. 157 applies to all other
accounting pronouncements requiring or permitting fair value measurements,
except for: SFAS No. 123R, share-based payment and related pronouncements,
the
practicability exceptions to fair value determinations allowed by various other
authoritative pronouncements, and AICPA Statements of Position 97-2 and 98-9
that deal with software revenue recognition. SFAS No. 157 is effective for
financial statements issued for fiscal years beginning after November 15, 2007,
and interim periods within those fiscal years. The Company is currently
assessing the potential effect of SFAS No. 157 on its consolidated financial
statements.
8
In
February 2007, the FASB issued Statement of Financial Accounting Standards
No.
159, “The Fair Value Option for Financial Assets and Financial Liabilities”
(“SFAS No. 159”), which provides companies with an option to report selected
financial assets and liabilities at fair value. The objective of SFAS No.
159 is to reduce both complexity in accounting for financial instruments and
the
volatility in earnings caused by measuring related assets and liabilities
differently. Generally accepted accounting principles have required different
measurement attributes for different assets and liabilities that can create
artificial volatility in earnings. SFAS No. 159 helps to mitigate this type
of
accounting-induced volatility by enabling companies to report related assets
and
liabilities at fair value, which would likely reduce the need for companies
to
comply with detailed rules for hedge accounting. SFAS No. 159 also establishes
presentation and disclosure requirements designed to facilitate comparisons
between companies that choose different measurement attributes for similar
types
of assets and liabilities. SFAS No. 159 requires companies to provide additional
information that will help investors and other users of financial statements
to
more easily understand the effect of the company’s choice to use fair value on
its earnings. SFAS No. 159 also requires companies to display the fair value
of
those assets and liabilities for which the company has chosen to use fair value
on the face of the balance sheet. SFAS No. 159 does not eliminate disclosure
requirements included in other accounting standards, including requirements
for
disclosures about fair value measurements included in SFAS No. 157 and SFAS
No.
107. SFAS No. 159 is effective as of the beginning of a company’s first fiscal
year beginning after November 15, 2007. Early adoption is permitted as of the
beginning of the previous fiscal year provided that the company makes that
choice in the first 120 days of that fiscal year and also elects to apply the
provisions of SFAS No. 157. The Company is currently assessing the potential
effect of SFAS No. 159 on its consolidated financial statements.
Management
does not believe that any other recently issued, but not yet effective,
accounting standards, if currently adopted, would have a material effect on
the
Company's financial statements.
Loss
Per Common Share
Loss
per
common share is computed by dividing net loss by the weighted average number
of
shares of common stock outstanding during the respective periods. Basic and
diluted loss per common share are the same for all periods presented because
all
warrants and stock options outstanding are anti-dilutive. The 19,021,786 shares
of common stock issued to the founder of Lixte in conjunction with the closing
of the reverse merger transaction on June 30, 2006 have been presented as
outstanding for all periods presented.
Research
and development costs are expensed as incurred. Amounts due, pursuant to
contractual commitments, on research and development contracts with third
parties are recorded as a liability, with the related amount of such contracts
recorded as advances on research and development contract services on the
Company’s balance sheet. Such advances on research and development contract
services are expensed over their life on the straight-line basis, unless the
achievement of milestones, the completion of contracted work, or other
information indicates that a different expensing schedule is more appropriate.
The Company accounts for its research and development contracts in accordance
with EITF 07-3.
The
funds
paid to NINDS of the NIH, pursuant to the CRADA effective March 22, 2006,
represent an advance on research and development costs and therefore have future
economic benefit. As such, such costs are being charged to expense when they
are
actually expended by the provider, which is, effectively, as they perform the
research activities that they are contractually committed to provide. Absent
information that would indicate that a different expensing schedule is more
appropriate (such as, for example, from the achievement of performance
milestones or the completion of contract work), such advances are being expensed
over the contractual service term on a straight-line basis, which reflects
a
reasonable estimate of when the underlying research and development costs are
being incurred. The Company’s $200,000 financial obligation due under the CRADA
as of March 22, 2007, was paid on June 29, 2007, and is intended to fund ongoing
research and development activities through March 2008.
3.
Share Exchange Agreement and Private Placement
Share
Exchange Agreement
On
June
30, 2006, pursuant to a Share Exchange Agreement dated as of June 8, 2006 (the
“Share Exchange Agreement”) by and among Holdings, Dr. John S. Kovach (“Seller”)
and Lixte, Holdings issued 19,021,786 shares of its common stock in exchange
for
all of the issued and outstanding shares of Lixte (the “Exchange”). Previously,
on October 3, 2005, Lixte had issued 1,500 shares of its no par value common
stock to its founder for $1,500, which constituted all of the issued and
outstanding shares of Lixte prior to the Exchange. As a result of the Exchange,
Lixte became a wholly-owned subsidiary of Holdings.
Pursuant
to the Exchange, Holdings issued to the Seller 19,021,786 shares of its common
stock. Holdings had a total of 25,000,832 shares of common stock issued and
outstanding after giving effect to the Exchange and the 1,973,869 shares of
common stock issued in the initial closing of the private
placement.
9
As
a
result of the Exchange and the shares of common stock issued in the initial
closing of the private placement, on June 30, 2006, the stockholders of the
Company immediately prior to the Exchange owned 4,005,177 shares of common
stock, equivalent to approximately 16% of the issued and outstanding shares
of
the Company’s common stock, and the Company is now controlled by the former
stockholder of Lixte.
The
Share
Exchange Agreement was determined through arms-length negotiations between
Holdings, the Seller and Lixte. In connection with the Exchange, the Company
paid WestPark Capital, Inc. an aggregate cash fee of $50,000.
Private
Placement
On
June 30, 2006, concurrently with the closing of the Exchange, the Company sold
an aggregate of 1,973,869 shares of its common stock to 26 accredited investors
in an initial closing of its private placement at a per share price of $0.333,
resulting in aggregate gross proceeds to the Company of $657,299. The Company
paid to WestPark Capital, Inc., as placement agent, a commission of 10% and
a
non-accountable fee of 4% of the gross proceeds of the private placement and
issued five-year warrants to purchase common stock equal to (a) 10% of the
number of shares sold in the private placement exercisable at $0.333 per share
and (b) an additional 2% of the number of shares sold in the private placement
also exercisable at $0.333 per share. A total of 236,864 warrants were issued.
Net cash proceeds to the Company, after the deduction of all private placement
offering costs and expenses, were $522,939.On
July
27, 2006, the Company sold an aggregate of 1,581,351 shares of its common stock
to 31 accredited investors in a second closing of the private placement at
a per
share price of $0.333 resulting in aggregate gross proceeds to the Company
of
$526,590. The Company paid to WestPark Capital, Inc., as placement agent, a
commission of 10% and a non-accountable fee of 4% of the gross proceeds of
the
private placement and issued five-year warrants to purchase common stock equal
to (a) 10% of the number of shares sold in the private placement exercisable
at
$0.333 per share and (b) an additional 2% of the number of shares sold in the
private placement also exercisable at $0.333 per share. A total of 189,762
warrants were issued. Net cash proceeds to the Company were
$446,433.
In
conjunction with the private placement of common stock, the Company issued
a
total of 426,626 five-year warrants to WestPark Capital, Inc. exercisable at
the
per share price of the common stock sold in the private placement ($0.333 per
share). The warrants issued to WestPark Capital, Inc. do not contain any price
anti-dilution provisions. However, such warrants contain cashless exercise
provisions and demand registration rights, but the warrant holder has agreed
to
waive any claims to monetary damages or financial penalties for any failure
by
the Company to comply with such registration requirements. Based on the
foregoing, the warrants have been accounted for as equity.
The
fair
value of the warrants, as calculated pursuant to the Black-Scholes
option-pricing model, was determined to be $132,254 ($0.31 per share) using
the
following Black-Scholes input variables: stock price on date of grant - $0.333;
exercise price - $0.333; expected life - 5 years; expected volatility - 150%;
expected dividend yield - 0%; risk-free interest rate - 5%.
As
part
of the Company’s private placement of its securities completed on July 27, 2006,
the Company entered into a registration rights agreement with the purchasers,
whereby the Company agreed to register the shares of common stock sold in the
private placement, and to maintain the effectiveness of such registration
statement, subject to certain conditions. The agreement required the Company
to
file a registration statement within 45 days of the closing of the private
placement and to have the registration statement declared effective within 120
days of the closing of the private placement. Since the registration statement
was not declared effective by the Securities and Exchange Commission within
120
days of the closing of the private placement, the Company was required to pay
each investor prorated liquidated damages equal to 1.0% of the amount raised
per
month, payable monthly in cash. On September 8, 2006, the Company filed a
registration statement on Form SB-2 to register 3,555,220 shares of the common
stock sold in the private placement.
In
accordance with EITF 00-19-2, “Accounting for Registration Payment
Arrangements”, on the date of the closing of the private placement, the Company
believed it would meet the deadlines under the registration rights agreement
with respect to filing a registration statement and having it declared effective
by the SEC. As a result, the Company did not record any liabilities associated
with the registration rights agreement at June 30, 2006. At December 31, 2006
(Restated), the Company determined that the registration statement covering
the
shares sold in the private placement would not be declared effective within
the
requisite time frame. As a result, the Company has accrued six months liquidated
damages under the registration rights agreement aggregating approximately
$74,000 as a current liability at June 30, 2007 and December 31, 2006
(Restated). No further registration penalty accrual was required at June 30,
2007, as the Company’s registration statement on Form SB-2 was declared
effective by the Securities and Exchange Commission on May 14, 2007. The Company
will continue to review the status of the registration statement at each quarter
end in the future and record further liquidated damages under the registration
rights agreement as necessary. As of June 30, 2007, the Company had not yet
paid
the registration penalty to the investors.
On
June
30, 2006, effective with the closing of the Exchange, the Company granted to
Dr. Philip Palmedo, an outside director of the Company, stock options to
purchase an aggregate of 200,000 shares of common stock, exercisable for a
period of five years at $0.333 per share, with one-third of the options (66,666
shares) vesting immediately upon joining the Board and one-third vesting
annually on each of June 30, 2007 and 2008. The fair value of these options,
as
calculated pursuant to the Black-Scholes option-pricing model, was determined
to
be $62,000 ($0.31 per share), of which $20,666 was charged to operations on
June
30, 2006, and the remaining $41,334 is being charged to operations ratably
from
July 1, 2006 through June 30, 2008. During the year ended December 31, 2006
(Restated), the three months ended June 30, 2007, and the six months ended
June
30, 2007, the Company recorded a charge to operations of $31,000, $5,167 and
$10,333, respectively, with respect to these options.
10
On
June
30, 2006, effective with the closing of the Exchange, the Company also granted
to Dr. Palmedo additional stock options to purchase 190,000 shares of
common stock exercisable for a period of five years at $0.333 per share for
services rendered in developing the business plan for Lixte, all of which were
fully vested upon issuance. The fair value of these options, as calculated
pursuant to the Black-Scholes option-pricing model, was determined to be $58,900
($0.31 per share), and was charged to operations at June 30, 2006.
On
June
30, 2006, effective with the closing of the Exchange, the Company granted to
certain members of its Scientific Advisory Committee stock options to purchase
an aggregate of 100,000 shares of common stock exercisable for a period of
five
years at $0.333 per share, with one-half of the options vesting annually on
each
of June 30, 2007 and June 30, 2008. The fair value of these options, as
calculated pursuant to the Black-Scholes option-pricing model, was initially
determined to be $31,000 ($0.31 per share). The fair value of such options
is
being charged to operations ratably from July 1, 2006 through June 30, 2008.
In
accordance with EITF 96-18, options granted to committee members are valued
each
reporting period to determine the amount to be recorded as an expense in the
respective period. On December 31, 2006 (Restated), and June 30, 2007, the
fair
value of these options, as calculated pursuant to the Black-Scholes
option-pricing model, was determined to be $30,000 ($0.30 per share) and $29,000
($0.29 per share), respectively, which resulted in a charge to operations of
$7,500 during the year ended December 31, 2006 (Restated), $3,625 during the
three months ended June 30, 2007, and $7,375 during the six months ended June
30, 2007. As the options vest, they will be valued one final time on each
vesting date and an adjustment will be recorded for the difference between
the
value already recorded and the then current value on the date of
vesting.
On
June
30, 2006, the fair value of the aforementioned stock options was initially
calculated using the following Black-Scholes input variables: stock price on
date of grant - $0.333; exercise price - $0.333; expected life - 5 years;
expected volatility - 150%; expected dividend yield - 0%; risk-free interest
rate - 5%. On December 31, 2006 (Restated), the Black-Scholes input variables
utilized to determine the fair value of the aforementioned stock options were
deemed to be the same as at June 30, 2006, except for an expected life of 4.5
years. On June 30, 2007, the Black-Scholes input variables utilized to determine
the fair value of the aforementioned stock options were deemed to be the same
as
at June 30, 2006, except for an expected life of 4 years.
On
June
20, 2007, the Board of Directors of the Company approved the 2007 Stock
Compensation Plan, which provides for the granting of awards, consisting of
common stock options, stock appreciation rights, performance shares, or
restricted shares of common stock, to employees and independent contractors,
for
up to 2,500,000 shares of the Company’s common stock, under terms and condition,
as determined by the Company’s Board of Directors. As of June 30, 2007, no
awards had been granted under the 2007 Stock Compensation Plan.
4.
Related Party Transactions
Since
inception, Dr. John Kovach, Lixte’s founding stockholder, has periodically made
advances to the Company to meet operating expenses. Such advances are
non-interest-bearing and are due on demand. At June 30, 2007 and December 31,
2006 (Restated), stockholder advances totaled $92,717.
The
Company’s office facilities have been provided without charge by the Company’s
founding stockholder and Chief Executive Officer. Such costs were not material
to the financial statements and, accordingly, have not been reflected
therein.
Dr.
John
Kovach, the Company’s Chief Executive Officer, is involved in other business
activities and may, in the future, become involved in other business
opportunities that become available. Accordingly, the Chief Executive Officer
may face a conflict in selecting between the Company and his other business
interests. The Company has not yet formulated a policy for the resolution of
such potential conflicts.
5.
Common Stock and Preferred Stock
The
Company’s Certificate of Incorporation provides for authorized capital of
110,000,000 shares, of which 100,000,000 shares are common stock with a par
value of $0.0001 per share and 10,000,000 shares are preferred stock with a
par
value of $0.0001 per share.
The
Company is authorized to issue 10,000,000 shares of preferred stock with such
designations, voting and other rights and preferences, as may be determined
from
time to time by the Board of Directors.
6.
Commitments and Contingencies
Effective
March 22, 2006, Lixte entered into a CRADA with the NINDS of the NIH. The CRADA
is for a term of two years from the effective date and may be unilaterally
terminated by either party by providing written notice within sixty days. The
CRADA provides for the collaboration between the parties in the identification
and evaluation of agents that target the Nuclear Receptor CoRepressor (N-CoR)
pathway for glioma cell differentiation. The CRADA also provided that NINDS
and
Lixte will conduct research to determine if expression of N-CoR correlates
with
prognosis in glioma patients. Pursuant to the CRADA, Lixte agreed to provide
funds under the CRADA in the amount of $200,000 per year to fund two technical
assistants for the technical, statistical and administrative support for the
research activities, as well as to pay for supplies and travel expenses. The
first installment of $200,000 was due within 180 days of the effective date
and
was paid in full on July 6, 2006. The second installment of $200,000 was paid
in
full on June 29, 2007.
11
On
January 5, 2007, Lixte entered into a Services Agreement with The Free State
of
Bavaria (Germany) represented by the University of Regensburg (the “University”)
pursuant to which Lixte retained the University to provide to it certain samples
of primary cancer tissue and related biological fluids to be obtained from
patients afflicted with specified types of cancer. The University will also
provide certain information relating to such patients. Lixte agreed to pay
the
University 72,000 Euros (approximately $99,700) in two installments of 36,000
Euros (approximately $49,850). The first installment was paid on March 7, 2007,
and the second installment will be paid within sixty days of the earlier of
(i)
January 5, 2008 or (ii) the University’s fulfillment of certain obligations
relating to the delivery of materials.
On
February 5, 2007, Lixte entered into a two-year agreement (the “Agreement”) with
Chem-Master International, Inc. (“Chem-Master”) pursuant to which Lixte engaged
Chem-Master to synthesize a compound designated as “LB-1”, and any other
compound synthesized by Chem-Master pursuant to Lixte’s request, which have
potential use in treating a disease, including, without limitation, cancers
such
as glioblastomas. Pursuant to the Agreement, Lixte agreed to reimburse
Chem-Master for the cost of materials, labor, and expenses for other items
used
in the synthesis process, and also agreed to grant Chem-Master a five-year
option to purchase 100,000 shares of the Company’s common stock at an exercise
price of $0.333 per share. The fair value of this option, as calculated pursuant
to the Black-Scholes option-pricing model, was determined to be $31,000 ($0.31
per share) using the following Black-Scholes input variables: stock price on
date of grant - $0.333; exercise price - $0.333; expected life - 5 years;
expected volatility - 150%; expected dividend yield - 0%; risk-free interest
rate - 4.5%. The $31,000 fair value was charged to operations as research
and development costs during the six months ended June 30, 2007, since the
option was fully vested and non-forfeitable on the date of issuance. Lixte
has the right to terminate the Agreement at any time during the term of the
Agreement upon sixty days prior written notice. On February 5, 2009,
provided that the Agreement has not been terminated prior to such date, the
Company agreed to grant Chem-Master a second five-year option to purchase
an additional 100,000 shares of the Company’s common stock at an exercise price
of $0.333 per share.
12
Overview
On
June
30, 2006, Lixte Biotechnology, Inc. (“Lixte”) a privately-held Delaware company
incorporated on August 9, 2005, completed a reverse merger transaction with
SRKP
7, Inc. (“SRKP 7”), a non-trading public “shell” company, whereby Lixte became a
wholly-owned subsidiary of SRKP 7. For financial reporting purposes, Lixte
was
considered the accounting acquirer in the merger and the merger was accounted
for as a reverse merger. Accordingly, the historical financial statements
presented herein are those of Lixte and do not include the historical financial
results of SRKP 7. All costs associated with the reverse merger transaction
were
expensed as incurred.
Lixte
was
formed to capitalize on opportunities to develop low cost, specific and
sensitive tests for the early detection of cancers to better estimate prognosis,
to monitor treatment response, and to reveal targets for development of more
effective treatments.
On
December 7, 2006, SRKP 7’s name was changed to Lixte Biotechnology Holdings,
Inc. Lixte Biotechnology Holdings, Inc. is a holding company for Lixte the
operating company acquired in the reverse merger transaction. Unless the context
indicates otherwise, Lixte Biotechnology Holdings, Inc. and Lixte are
hereinafter referred to collectively as the “Company”.
As
a
result of the reverse merger, the Company is now concentrating on discovering
biomarkers for common cancers for which better diagnostic and therapeutic
measures are needed. For each of these diseases, a biomarker that would enable
identification of the presence of cancer at a stage curable by surgery could
possibly save thousands of lives annually. In addition, biomarkers specific
to
these diseases may also provide clues as to processes (biological pathways)
that
characterize specific cancer types and that may be vulnerable to drug treatment
targeted to the activity of the biomarker.
Adoption
of New Accounting Policies
In
December 2006, the FASB issued FSP EITF 00-19-2, “Accounting for
Registration Payment Arrangements” (“EITF 00-19-2”), which addresses an issuer’s
accounting for registration payment arrangements. EITF 00-19-2 specifies that
the contingent obligation to make future payments or otherwise transfer
consideration under a registration payment arrangement, whether issued as a
separate agreement or included as a provision of a financial instrument or
other
agreement, should be separately recognized and measured in accordance with
FASB
No. 5, “Accounting for Contingencies”. EITF 00-19-2 further clarifies that a
financial instrument subject to a registration payment arrangement should be
accounted for in accordance with other applicable generally accepted accounting
principles without regard to the contingent obligation to transfer consideration
pursuant to the registration payment arrangement. EITF 00-19-2 is effective
immediately for registration payment arrangements and the financial instruments
subject to those arrangements that are entered into or modified subsequent
to
the date of issuance of EITF 00-19-2. For registration payment arrangements
and
financial instruments subject to those arrangements that were entered into
prior
to the issuance of EITF 00-19-2, EITF 00-19-2 is effective for financial
statements issued for fiscal years beginning after December 15, 2006, and
interim periods within those fiscal years. Early adoption of EITF 00-19-2 for
interim or annual periods for which financial statements or interim reports
have
not been issued is permitted. The Company chose to early adopt EITF 00-19-2
effective December 31, 2006.
The
Company files income tax returns in the U.S. federal jurisdiction and various
states. The Company is subject to U.S. federal or state income tax examinations
by tax authorities for years beginning in 2005.
The
Company’s policy is to record interest and penalties on uncertain tax provisions
as income tax expense. As of June 30, 2007, the Company has no accrued interest
or penalties related to uncertain tax positions.
Recent
Accounting Pronouncements
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No.
157, “Fair Value Measurements” (“SFAS No. 157”), which establishes a formal
framework for measuring fair value under generally accepted accounting
principles. SFAS No. 157 defines and codifies the many definitions of fair
value
included among various other authoritative literature, clarifies and, in some
instances, expands on the guidance for implementing fair value measurements,
and
increases the level of disclosure required for fair value measurements. Although
SFAS No. 157 applies to and amends the provisions of existing FASB and AICPA
pronouncements, it does not, of itself, require any new fair value measurements,
nor does it establish valuation standards. SFAS No. 157 applies to all other
accounting pronouncements requiring or permitting fair value measurements,
except for: SFAS No. 123R, share-based payment and related pronouncements,
the
practicability exceptions to fair value determinations allowed by various other
authoritative pronouncements, and AICPA Statements of Position 97-2 and 98-9
that deal with software revenue recognition. SFAS No. 157 is effective for
financial statements issued for fiscal years beginning after November 15, 2007,
and interim periods within those fiscal years. The Company is currently
assessing the potential effect of SFAS No. 157 on its consolidated financial
statements.
13
Management
does not believe that any other recently issued, but not yet effective,
accounting standards, if currently adopted, would have a material effect on
the
Company's financial statements.
Critical
Accounting Policies and Estimates
The
Company prepared the consolidated financial statements in accordance with
accounting principles generally accepted in the United States of America. The
preparation of these financial statements requires the use of estimates and
assumptions that affect the reported amounts of assets and liabilities and
the
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amount of revenues and expenses during the reporting
period. Management periodically evaluates the estimates and judgments made.
Management bases its estimates and judgments on historical experience and on
various factors that are believed to be reasonable under the circumstances.
Actual results may differ from these estimates as a result of different
assumptions or conditions.
The
following critical accounting policies affect the more significant judgments
and
estimates used in the preparation of the Company’s consolidated financial
statements.
Research
and Development
Research
and development costs are expensed as incurred. Amounts due on research and
development contracts with third parties are recorded as a liability, with
the
related amount of such contracts recorded as advances on research and
development contract services on the Company’s balance sheet. Such advances on
research and development contract services are expensed over their life on
the
straight-line basis, unless the achievement of milestones, the completion of
contracted work, or other information indicates that a different expensing
schedule is more appropriate. The Company accounts for its research and
development contracts in accordance with EITF 07-3.
Stock-Based
Compensation
In
December 2004, the FASB issued Statement of Financial Accounting Standards
No.
123R, “Share-Based Payment” (“SFAS 123R”). SFAS 123R requires all share-based
payments, including grants of employee stock options to employees, to be
recognized in the financial statements based on their grant date fair values.
Effective January 1, 2006, SFAS 123R requires that the Company measure the
cost
of employee services received in exchange for equity awards based on the grant
date fair value of the awards, with the cost to be recognized as compensation
expense in the Company’s financial statements over the vesting period of the
awards.
The
Company accounts for income taxes under Statement of Financial Accounting
Standards No. 109, “Accounting for Income Taxes”, which requires the
recognition of deferred tax assets and liabilities for the expected impact
of
differences between the financial statements and the tax basis of assets and
liabilities.
For
federal income tax purposes, substantially all expenses must be deferred until
the Company commences business operations and then they may be written off
over
a 60-month period. These expenses will not be deducted for tax purposes and
will
represent a deferred tax asset. The Company provides a valuation allowance
for
the full amount of the deferred tax asset since there is no assurance of future
taxable income. Tax deductible losses can be carried forward for 20 years until
utilized.
14
Plan
of Operation
The
Company’s initial focus is on developing new treatments for the most common and
most aggressive type of primary brain cancer, glioblastoma multiforme (“GBM”).
The Company entered into a Cooperative Research and Development Agreement (the
“CRADA”) with the National Institute of Neurological Diseases and Stroke
(“NINDS”) of the National Institutes of Health (“NIH”) to identify and evaluate
drugs that target a specific biochemical pathway for GBM cell differentiation.
The CRADA also covers research to determine whether expression of a component
of
this pathway correlates with prognosis in glioma patients.
The
lead
scientist at NINDS collaborating with the Company under the CRADA is Dr.
Zhengping Zhuang. Dr. Zhuang is internationally recognized for his research
in
molecular pathology. Dr. Zhuang has four issued and two pending patents related
to molecular pathology of human cancers. Dr. Zhuang recently discovered a
biomarker of relevance to the growth of GBMs that the Company believes can
be
used as a tool for identifying drugs that affect the growth of GBM cells. Under
the CRADA, the Company will support two persons at the NIH to work under the
direction of Dr. Zhuang. The goal is to identify drugs that inhibit GBM cell
growth and to determine if the identified biomarker may be useful for estimation
of prognosis. The Company’s contribution to the collaborative research done by
the Company and the NIH is $200,000 annually for two years to fund two research
assistants expected to be at the post-doctoral level, as well as supplies and
travel expenses.
On
February 6, 2006, the Company filed a provisional patent application naming
as co-inventors Dr. Zhuang and several other NIH investigators, and
Dr. Kovach covering certain methods and classes of molecules that are
expected to be the foundation of product development and commercialization
efforts with respect to human brain tumors. On February 6, 2007, the
Company filed on behalf of NIH co-inventors and Dr. Kovach a PCT
international patent including all countries participating in the Patent
Cooperation Treaty (except the USA) and an identical non-provisional patent
in
the USA. These two patent applications contain all claims in the provisional
patent of February 6, 2006 plus additional claims. The Company has received
a draft of the proposed exclusive patent license agreement with the
NIH.
On
February 6, 2007, the Company also filed a new U.S. provisional application
in
its sole name. This filing does not fall under the CRADA. The Company has the
sole right to any patent issued pursuant to this application. This application
identifies a method of synthesis and documents activity against glioblastoma
multiforme cell lines in vitro of a proprietary lead compound synthesized by
the
Company. This provisional patent application also describes a series of homologs
of this lead compound.
The
Company expects that the products will derive directly from its intellectual
property, which will consist of patents that the Company anticipates will arise
out of its research activities. These patents are expected to cover biomarkers
uniquely associated with the specific types of cancer, patents on methods to
identify drugs that inhibit growth of specific tumor types, and combinations
of
drugs and potential drugs and potential therapeutic agents for the treatment
of
specific cancers.
The
Company faces several potential challenges in its efforts to achieve commercial
success, including raising sufficient capital to fund its business plan,
achieving commercially applicable results of its research program, continued
access to tissue and blood samples from cancer patients, competition from more
established, well-funded companies with competitive technologies, and future
competition from companies that are developing competitive technologies, some
of
whom are larger companies with greater capital resources than the
Company.
There
is
substantial uncertainty as to the Company’s ability to fund its operations and
continue as a going concern (see “Liquidity and Capital Resources - June 30,
2007 - Going Concern” below).
The
Company has two major goals to achieve over the next 12 months. The prime
objective, in collaboration with NINDS under the CRADA, is to extend the
characterization of potentially more effective drugs and drug combinations
(identified by the Company and jointly with NINDS for the treatment of the
incurable human brain tumor, GBM. The second goal is to obtain well
characterized samples of common human cancers other than GBM under conditions
needed to identify new biomarkers for the earlier detection and identification
of biochemical pathways as potential targets for new
treatments.
15
Goal
I: Development of More Effective Regimens for the Treatment of
GBM
Over
the
next 12 months, the Company will continue to develop preclinical data supporting
the potential effectiveness of several drugs for the treatment of GBM when
used
alone or in combination. The drugs that have been identified as active in vitro
have never been used for the treatment of GBM in humans. Some of these compounds
were included in claims of a provisional patent filed jointly by the Company
and
NINDS in February 2006. Over the past 12 months, the activity of these drugs
has
been documented and several new lead compounds were identified. This work was
done under the CRADA. The combinations of several pairs of lead drugs appear
to
have some specificity for GBM in that at equimolar doses these drugs are more
active against GBMs than against other human cancer cell types tested. Some
of
the drug combinations are synergistic in their ability to inhibit the growth
of
GBMs, e.g., the combination of two drugs inhibits GBMs to a greater extent
than
would be expected from the sum of their inhibitory effects when used
alone.
Over
the
next 12 months, the Company will evaluate two or more lead compounds alone
and
in combination for activity against human GBMs in an animal (mouse) model.
These
evaluations will be done at the NIH under protocols developed by NINDS and
the
Company. The protocols will be approved by NIH committees responsible for
approving the conduct of animal research at the NIH and will be carried out
by
NIH personnel as a joint activity under the CRADA. The CRADA agreement specifies
evaluation of drug regimens in animal models as one of the activities to be
pursued by the Company and NINDS. It is anticipated that the animal studies
will
include three regimens identified under the CRADA that have never been
investigated as treatment for human GBMs. The Company expects initial animal
studies at the NIH will be completed in September 2007.
If
the
current animal experiments at the NIH show anti-cancer activity against GBMs
without significant toxicity, the Company will rapidly expand the evaluation
of
the lead compound(s) by screening for anti-cancer activity against other types
of human cancers not included under the CRADA. The Company will also evaluate
the activity of its lead compound(s) in an animal (mouse) model of GBM in which
human GBM cells are growing intra-cranially. These studies will be outsourced
to
a contract research organization (“CRO”) experienced in the evaluation and
pharmacologic characterization of new anti-cancer agents under conditions
required by the National Cancer Institute and the FDA. The Company will contract
for these studies because the scope of the activities and the technical demands
for this type of animal study lies outside the agreement and capabilities of
its
NIH partner. As a result, the Company’s projected operating budget will increase
by approximately $500,000 to reflect the costs of carrying out these evaluations
with a CRO and the costs of additional patent applications and the maintenance
of the national and international status of filed applications.
As
the
effectiveness of lead regimens against GBMs in the animal model is determined,
a
decision will be made as to which regimens are most promising for development
for human studies. This decision will be made jointly by the Company with the
advice of its scientific advisory board and its CRADA partner, NINDS. At this
point, NINDS and the Company will consider whether development of specific
regimens for evaluation in humans should proceed via an extension of the
existing CRADA, under a new CRADA with NINDS, or possibly with another institute
at the NIH, by the Company alone via outsourcing all pre-clinical drug
evaluations required by the FDA to a commercial CRO, and/or with a partner
in
the pharmaceutical industry capable of taking the drug(s) though the IND process
and conducting clinical evaluations.
The
Company expects to participate in clinical trials of new therapies in
partnership with an organization experienced in such undertakings. The
partnering organization may be either a clinical branch of NIH or a
pharmaceutical company with expertise in the conduct of clinical trials. The
Company’s present position is to take one or more of its new therapies for the
treatment of glioblastoma multiforme through pre-clinical evaluation as part
of
the CRADA agreement with the NINDS of the NIH. After completing pre-clinical
evaluation, the Company will consider partnering with the NIH to conduct a
phase I trial or jointly with the NIH seek a third party, most probably a
large pharmaceutical company to carry the new therapies into phase I
trials.
After
completion of phase I trials, the Company, potentially in partnership with
the NIH or on its own, would collaborate with the third party to carry new
therapies found to be safe for administration to humans in the phase I
trials into phase II trials.
Phase II
trials test the safety and effectiveness, as well as the best estimate of the
proper dose of the new therapies in a group of patients with the same type
of
cancer at the same stage. For the Company’s initial studies, the focus will be
brain tumors. The duration of phase II trials may run from 6 to 24 months.
New regimens showing beneficial activity in phase II trials may then be
considered for evaluation in phase III trials. Phase III trials for
the evaluation of new cancer treatments are comparative trials in which the
therapeutic benefit of a new regimen is compared to the therapeutic benefit
of
the best standard regimen in a randomized study.
16
Whether
the Company will participate or be in a position to participate in any clinical
trials will depend upon partnerships and specific licensing agreements. In
all
cases of clinical trial participation, however, the Company will be subject
to
FDA regulation. These regulations are specific and form the basis for assessing
the potential clinical benefit of new therapeutic regimens while safeguarding
the health of patients participating in investigational studies. Even after
a
drug receives approval from the FDA for sale as a new treatment for a specific
disease indication, the sponsors of the drug are subject to reporting
potentially adverse effects of a new regimen to the FDA.
Goal
II: Collection of Human Tumor Samples
Over
the
next 12 months, samples of human tumors and associated blood and urine samples
will be collected by the University of Regensburg under the Company’s January 5,
2007 agreement with the Free State of Bavaria, Germany. Technology comparable
to
that used to detect the biomarker for GBM will be applied to these tumors to
identify new biomarkers for cancers of the breast, colon, stomach, kidney,
bladder, prostate, and ovary. The present CRADA with NINDS is limited to the
study of GBM.
In
late
2008, the Company expects to be in a position to begin analyses of tumor types
other than GBM. In order to do this, the Company estimates that it will need
to
establish and operate a laboratory for a period of two years (originally
estimated to be 2008 and 2009, now estimated to be 2009 and 2010) to
proceed with biomarker discovery in cancers other than GMB independent of the
NIH. The creation and operation of the laboratory for two years is estimated
to
cost approximately $1,700,000. The Company will continue to incur additional
costs, including, among others, patent, legal, accounting/audit,
insurance and office expenses. Accordingly, the Company’s revised operating
budget indicates that in addition to the estimated $1,500,000 required to fund
operations through December 2008, the Company will also require an additional
$3,500,000 to fund operations (including laboratory operations) in 2009 and
2010. The Company anticipates funding these cash requirements from debt or
equity financings, mergers or acquisitions, and/or via the sale or license
of
certain of its assets (including licensing rights to compounds for the treatment
of GBMs).
The
laboratory (rented space) is expected to be located in a biotechnology incubator
of the State of Maryland in close proximity to the NIH or comparable incubator
near an academic biomedical research center. This incubator offers low-cost,
high-quality space and shared resources necessary for molecular biology
research. Because of proximity to the NIH or other academic biomedical research
centers, the Company will have access to many highly trained scientists and
technical personnel to staff the laboratory.
Year
1:
|
|
|
$48,000
|
|
for
rental of 800 sq. ft. wet lab in MD incubator ($4,000/month plus
utilities/phone/internet)
|
$300,000
|
|
for
staff salaries plus fringe (1 scientist and 2
technicians)
|
$100,000
|
|
for
disposable equipment and reagents ($33,000/lab person)
|
$300,000
|
|
for
equipment (one-time expense)
|
$100,000
|
|
for
outsourced technical services (LC/MS/MS, immunoassay
development)
|
Total
Year 1:
|
|
$848,000
|
Year
2:
|
|
|
$50,400
|
|
for
rental of wet lab
|
$315,000
|
|
for
staff salaries
|
$105,000
|
|
for
supplies
|
$300,000
|
|
for
outsource technology services (LC/MS/MS, immunoassay
development)
|
Total
Year 2:
|
|
$770,400
|
Budget
summary (2 years):
Total budgeted costs for laboratory operations | $ | 1,318,400 | ||
Equipment | $ | 300,000 | ||
Miscellaneous | $ | 81,600 | ||
Total budget | $ | 1,700,000 |
The
Company is a development stage company and has not yet commenced
revenue-generating operations. Comparative financial statements for the three
months and six months ended June 30, 2006 reflect the results of operations
of
Lixte Biotechnology, Inc. the Company’s operating subsidiary, as it was the
accounting acquirer in the reverse merger transaction.
17
Three
Months Ended June 30, 2007 and 2006
General
and Administrative Expenses.
For the
three months ended June 30, 2007, general and administrative expenses were
$104,233, which included $8,792 for the vested portion of the fair value of
stock options issued to a director and certain members of the Company’s
Scientific Advisory Committee on June 30, 2006, as compared to $113,869 for
the
three months ended June 30, 2006, which included $79,566 for the vested portion
of the fair value of stock options issued to a director and certain members
of
the Company’s Scientific Advisory Committee on June 30, 2006. The significant
components of general and administrative expenses to date consist primarily
of
legal and accounting fees, including costs associated with the registration
of
the common stock sold in the Company’s private placement in June and July
2006.
Depreciation.
For the
three months ended June 30, 2007 and 2006, depreciation expense was $148 and
$114, respectively.
Research
and Development Costs.
For the
three months ended June 30, 2007, research and development costs were $74,925,
as compared to $50,000 for the three months ended June 30, 2006.
Reverse
Merger Costs.
In
conjunction with the reverse merger transaction completed on June 30, 2006,
WestPark Capital, Inc. was paid a cash fee of $45,000 on June 30, 2006, which
was charged to operations during the three months ended June 30,
2006.
Interest
Income.
For the
three months ended June 30, 2007, interest income was $3,584. The Company did
not have any interest income for the three months ended June 30,
2006.
Net
Loss.
For the
three months ended June 30, 2007, the Company incurred a net loss of $175,722,
as compared to a net loss of $208,983 for the three months ended June 30,
2006.
Six
Months Ended June 30, 2007 and 2006
General
and Administrative Expenses.
For the
six months ended June 30, 2007, general and administrative expenses were
$255,986, which included $17,708 for the vested portion of the fair value of
stock options issued to a director and certain members of the Company’s
Scientific Advisory Committee on June 30, 2006, as compared to $135,853 for
the
six months ended June 30, 2006, which included $79,566 for the vested portion
of
the fair value of stock options issued to a director and certain members of
the
Company’s Scientific Advisory Committee on June 30, 2006. The significant
components of general and administrative expenses to date consist primarily
of
legal and accounting fees, including costs associated with the registration
of
the common stock sold in the Company’s private placement in June and July
2006.
Depreciation.
For the
six months ended June 30, 2007 and 2006, depreciation expense was $296 and
$229,
respectively.
Research
and Development Costs.
For the
six months ended June 30, 2007, research and development costs were $180,850,
including $31,000 of stock-based expense related to a five-year stock option
to
purchase 100,000 shares of the Company’s common stock at $0.333 per share issued
to Chem-Master International, Inc. on February 5, 2007 that was fully vested
and
non-forfeitable on the date of issuance. Research and development costs were
$50,000 for the six months ended June 30, 2006.
Reverse
Merger Costs.
In
conjunction with the reverse merger transaction completed on June 30, 2006,
WestPark Capital, Inc. was paid an aggregate cash fee of $50,000, which was
charged to operations during the six months ended June 30, 2006.
Interest
Income.
For the
six months ended June 30, 2007, interest income was $8,307. The Company did
not
have any interest income for the six months ended June 30, 2006.
Net
Loss.
For the
six months ended June 30, 2007, the Company incurred a net loss of $428,825,
as
compared to a net loss of $236,082 for the six months ended June 30,
2006.
Liquidity
and Capital Resources - June 30, 2007
Going
Concern
At
June
30, 2007, the Company had not yet commenced any revenue-generating operations
and was therefore considered a “development stage company”. All activity through
June 30, 2007 related to the Company’s formation, capital raising efforts and
initial research and development activities. As such, the Company has yet to
generate any cash flows from operations, and is essentially dependent on debt
and equity funding from both related and unrelated parties to finance its
operations. Prior to June 30 2006, the Company’s cash requirements were funded
by advances from its founder, Dr. John Kovach, the Company’s Chief Executive
Officer. On June 30, 2006, the Company completed an initial closing of its
private placement, selling 1,973,869 shares of common stock at a price of $0.333
per share and receiving net proceeds of $522,939. On July 27, 2006, the Company
completed a second closing of its private placement, selling 1,581,351 shares
of
common stock at a price of $0.333 per share and receiving net proceeds of
$446,433.
18
Because
the Company is currently engaged in research at a very early stage, it will
likely take a significant amount of time to develop any product or intellectual
property capable of generating revenues. As such, the Company’s business is
unlikely to generate any revenue in the next several years and may never do
so.
Even if the Company is able to generate revenues in the future through licensing
its technologies or through product sales, there can be no assurance that such
revenues will exceed its expenses.
The
Company does not currently have sufficient resources to fully fund its planned
operations for the next twelve months. The strain on the Company’s limited cash
resources has been further exacerbated by the registration penalty obligation
of
$74,000 (originally recorded at December 31, 2006 pursuant to EITF 00-19-2),
reflecting the cash amount currently payable to the investors in the private
placement for the registration penalty accrued through mid-May 2007. If the
Company does not maintain the effectiveness of its registration statement,
the
Company would be subject to a further registration penalty at the rate of
approximately $12,000 per 30-day period thereafter, continuing through July
2008. Since the Company only has cash of $194,671 and working capital of
$171,409 (including the effect from the $74,000 registration penalty obligation
referred to above) at June 30, 2007, this short-term cash obligation and the
uncertainty related to it could have a material adverse impact on the Company’s
ability to fund its business plan and conduct operations.
Since
inception, Dr. John Kovach, Lixte’s founding stockholder, has periodically made
advances to the Company to meet operating expenses. Such advances are
non-interest-bearing and are due on demand. At June 30, 2007 and December 31,
2006 (Restated), stockholder advances totaled $92,717. The Company currently
does not anticipate repaying such advances until sufficient funds are available
to fund the Company’s business plan.
The
Company does not have sufficient resources to fully develop and commercialize
any products that may arise from its research. Accordingly, the Company will
need to raise additional funds in order to satisfy its future working capital
requirements. Through December 31, 2008, the Company estimates that it will
require approximately $1,500,000 of additional funding. The Company estimates
that it will require an additional $3,500,000 to fund operations (including
laboratory operations) in 2009 and 2010. The amount and timing of future cash
requirements will depend on market acceptance of the Company’s products, if any,
and the resources that the Company devotes to developing and supporting its
products. The Company anticipates funding these cash requirements from debt
or
equity financings, mergers or acquisitions, and/or via the sale or license
of
certain of its assets.
Operating
Activities.
For the
six months ended June 30, 2007, operating activities utilized cash of $484,697,
as compared to utilizing cash of $93,329 for the six months ended June 30,
2006.
The
Company had working capital of $171,409 at June 30, 2007, primarily as a result
of the sale of the Company’s common stock pursuant to private placement in June
and July 2006 that generated net proceeds of $969,372.
Investing
Activities.
For the
six months ended June 30, 2007 and 2006, investing activities utilized net
cash
of $272 and $237, respectively, for the purchase of office
equipment.
Financing
Activities.
There
were no financing activities for the six months ended June 30, 2007. For the
six
months ended June 30, 2006, financing activities provided net cash of $672,210,
consisting of the gross proceeds from the sale of common stock of $657,299,
the
cash acquired in the reverse merger transaction of $62,500, and advances from
stockholder of $86,771, reduced by the payment of private placement offering
costs of $134,360.
Principal
Commitments
At
June
30, 2007, the Company did not have any material commitments for capital
expenditures. The Company’s principal commitments at June 30, 2007 consisted of
the estimated liquidated damages payable under the registration rights agreement
of $74,000 and the contractual obligations as summarized below.
On
January 5, 2007, Lixte entered into a Services Agreement with The Free State
of
Bavaria (Germany) represented by the University of Regensburg (the “University”)
pursuant to which Lixte retained the University to provide to it certain samples
of primary cancer tissue and related biological fluids to be obtained from
patients afflicted with specified types of cancer. The University will also
provide certain information relating to such patients. Lixte agreed to pay
the
University 72,000 Euros (approximately $100,000) in two installments of 36,000
Euros (approximately $50,000). The first installment was paid on March 7, 2007,
and the second installment will be paid within sixty days of the earlier of
(i)
January 5, 2008 or (ii) the University’s fulfillment of certain obligations
relating to the delivery of materials.
19
On
February 5, 2007, Lixte entered into a two-year agreement (the “Agreement”) with
Chem-Master International, Inc. (“Chem-Master”) pursuant to which Lixte engaged
Chem-Master to synthesize a compound designated as “LB-1”, and any other
compound synthesized by Chem-Master pursuant to Lixte’s request, which have
potential use in treating a disease, including, without limitation, cancers
such
as glioblastomas. Pursuant to the Agreement, Lixte agreed to reimburse
Chem-Master for the cost of materials, labor, and expenses for other items
used
in the synthesis process, and also agreed to grant Chem-Master a five-year
option to purchase 100,000 shares of the Company’s common stock at an exercise
price of $0.333 per share. The fair value of this option, as calculated
pursuant to the Black-Scholes option-pricing model, was determined to be $31,000
($0.31 per share) using the following Black-Scholes input variables: stock
price
on date of grant - $0.333; exercise price - $0.333; expected life - 5 years;
expected volatility - 150%; expected dividend yield - 0%; risk-free interest
rate - 4.5%. The $31,000 fair value was charged to operations as research
and development costs during the six months ended June 30, 2007, since the
option was fully vested and non-forfeitable on the date of issuance. Lixte
has the right to terminate the Agreement at any time during the term of the
Agreement upon sixty days prior written notice. On February 5, 2009,
provided that the Agreement has not been terminated prior to such date,
Lixte agreed to grant Chem-Master a second five-year option to purchase an
additional 100,000 shares of the Company’s common stock at an exercise price of
$0.333 per share.
Off-Balance
Sheet Arrangements
At
June
30, 2007, the Company did not have any transactions, obligations or
relationships that could be considered off-balance sheet
arrangements.
20
ITEM
3. CONTROLS AND PROCEDURES
(a)
|
Evaluation
of Disclosure Controls and
Procedures
|
Disclosure
Controls and procedures are designed to ensure that information required to
be
disclosed in the reports filed or submitted under the Exchange Act is recorded,
processed, summarized and reported, within the time periods specified in the
SEC’s rules and forms. Disclosure controls and procedures include, without
limitation, controls and procedures designed to ensure that information required
to be disclosed in the reports filed under the Exchange Act is accumulated
and
communicated to management.
As
of
June 30, 2007, the Company’s Chief Executive Officer and Chief Financial Officer
(who is the same individual) evaluated the effectiveness of the design and
operation of the Company’s disclosure controls and procedures. Based upon and as
of the date of that evaluation, the Chief Executive Officer and Chief Financial
Officer concluded that the Company’s disclosure controls and procedures are
effective to ensure that the information required to be disclosed in the reports
the Company files and submits under the Exchange Act is recorded, processed,
summarized, and reported as and when required.
(b)
|
Changes
in Internal Controls Over Financial
Reporting
|
There
were no changes in the Company’s internal control over financial reporting or in
other factors that materially affect, or are reasonably likely to materially
affect, those controls subsequent to the date of the Company’s most recent
evaluation.
21
PART
II. OTHER INFORMATION
Item
1.
Legal Proceedings
The
Company is currently not a party to any pending or threatened legal
proceedings.
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
Not
applicable.
Item
3.
Defaults Upon Senior Securities
Not
applicable.
Item
4.
Submission of Matters to a Vote of Security Holders
Not
applicable.
Item
5.
Other Information
Not
applicable.
Item
6.
Exhibits
A
list of
exhibits required to be filed as part of this report is set forth in the Index
to Exhibits, which immediately precedes such exhibits, and is incorporated
herein by reference.
22
SIGNATURES
In
accordance with the requirements of the Securities and Exchange Act of 1934,
the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
LIXTE BIOTECHNOLOGY HOLDINGS, | ||
(Registrant) | ||
|
|
|
Date: August 13, 2007 | By: | /s/ JOHN S. KOVACH |
John
S. Kovach
|
||
Chief
Executive Officer and Chief Financial Officer
(Principal
financial and accounting
officer)
|
23
INDEX
TO
EXHIBITS
Exhibit
Number
|
Description
of Document
|
|
|
10.1
|
Services
Agreement between Lixte Biotechnology, Inc. and Freestate of Bavaria
represented by
|
|
University
of Regensburg dated January 5, 2007, previously filed as an exhibit
to
the
|
|
Company’s
Current Report on Form 8-K filed on January 11, 2007, and incorporated
herein by
|
|
reference.
|
|
|
10.2
|
Agreement
between Lixte Biotechnology Holdings, Inc. and Chem-Master International,
Inc.
|
|
dated
February 5, 2007, previously filed as an exhibit to the Company’s Current
Report on Form
|
|
8-K
filed on February 9, 2007, and incorporated herein by
reference.
|
|
|
10.3
|
2007
Stock Compensation Plan adopted by the Company’s Board of Directors on
June 20, 2007. (1)
|
31
|
Certifications
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
(1)
|
|
|
32
|
Certifications
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(1)
|
(1)
Filed
herewith.
24