10QSB: Optional form for quarterly and transition reports of small business issuers
Published on May 21, 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 March
31, 2007
|
|||
o
|
|||
Commission
file number: 000-51476
|
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
April 30, 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
PART
I - FINANCIAL INFORMATION
|
|
|
|
Item
1. Condensed Financial Statements
|
|
|
|
Condensed
Consolidated Balance Sheets -
|
|
|
|
March
31, 2007 (Unaudited) and December 31, 2006
|
1
|
|
|
Condensed
Consolidated Statements of Operations (Unaudited) -
|
|
|
|
Three
Months Ended March 31, 2007 and 2006, and August 9, 2005 (Inception)
to March 31,
2007
(Cumulative)
|
2
|
|
|
Condensed
Consolidated Statement of Changes in Stockholders’ Equity (Deficiency)
(Unaudited) -
|
|
|
|
August 9,
2005 (Inception) to March 31, 2007
|
3
|
|
|
Condensed
Consolidated Statements of Cash Flows (Unaudited) -
|
|
|
|
Three
Months Ended March 31, 2007 and 2006, and August 9, 2005 (Inception)
to March 31,
2007
(Cumulative)
|
4
|
|
|
Notes
to Condensed Consolidated Financial Statements -
|
|
|
|
March
31, 2007 (Unaudited) and December 31, 2006
|
6
|
|
|
Item
2. Management’s Discussion and Analysis or Plan of
Operation
|
15
|
|
|
Item
3. Controls and Procedures
|
26
|
PART
II - OTHER INFORMATION
|
|
||
|
|
|
|
Item
1
|
|
Legal
Proceedings
|
27
|
|
|
|
|
Item
2
|
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
27
|
|
|
|
|
Item
3
|
|
Defaults
Upon Senior Securities
|
27
|
|
|
|
|
Item
4
|
|
Submission
of Matters to a Vote of Security Holders
|
27
|
|
|
|
|
Item
5
|
|
Other
Information
|
27
|
|
|
|
|
Item
6
|
|
Exhibits
|
27
|
|
|
|
|
SIGNATURES
|
|
28
|
i
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED BALANCE SHEETS
March
31,
2007
(Unaudited)
|
December
31,
2006
(Restated)
|
||||||
ASSETS
|
|
||||||
Current
assets:
|
|
||||||
Cash
and cash equivalents
|
$
|
536,616
|
$
|
679,640
|
|||
Advances
on research and development contract services
|
237,387
|
50,000
|
|||||
Prepaid
insurance
|
13,177
|
20,365
|
|||||
Total
current assets
|
787,180
|
750,005
|
|||||
Office
equipment,
net of accumulated depreciation of $723 at March 31, 2007
and
$575 at December 31, 2006
|
1,186
|
1,062
|
|||||
Total
assets
|
$
|
788,366
|
$
|
751,067
|
|||
|
|||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
68,861
|
$
|
31,786
|
|||
Estimated
liquidated damages payable under registration rights
agreement
|
74,000
|
74,000
|
|||||
Research
and development contract liabilities
|
213,410
|
---
|
|||||
Due
to stockholder
|
92,717
|
92,717
|
|||||
Total
current liabilities
|
448,988
|
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
|
1,168,031
|
1,128,114
|
|||||
Deficit
accumulated during the development stage
|
(831,311
|
)
|
(578,208
|
)
|
|||
Total
stockholders’ equity
|
339,378
|
552,564
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
788,366
|
$
|
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
March 31,
|
Period from
August 9,
2005
(Inception)
to
March 31,
2007
|
|||||||||
2007
|
2006
|
(Cumulative)
|
||||||||
Revenues
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
|
||||||||||
Costs
and expenses:
|
||||||||||
General
and administrative, including $8,917 of stock-based compensation
during
the three months ended March 31, 2007 and $106,317 for the period
from
August 9, 2005 (inception) to March 31, 2007 (cumulative)
|
182,753
|
21,984
|
498,184
|
|||||||
Depreciation
|
148
|
115
|
723
|
|||||||
Research
and development costs, including $31,000 of stock-based expense
during the
three months ended March 31, 2007 and the period from August 9,
2005
inception) to March 31, 2007 (cumulative)
|
74,925
|
—
|
225,025
|
|||||||
Reverse
merger costs
|
---
|
5,000
|
50,000
|
|||||||
Total
costs and expenses
|
257,826
|
27,099
|
773,932
|
|||||||
|
(257,826
|
)
|
(27,099
|
)
|
(773,932
|
)
|
||||
Interest
income
|
4,723
|
—
|
16,621
|
|||||||
Estimated
liquidated damages under registration rights agreement
|
---
|
—
|
(74,000
|
)
|
||||||
Net
loss
|
$
|
(253,103
|
)
|
$
|
(27,099
|
)
|
$
|
(831,311
|
)
|
|
Net
loss per common share - basic and diluted
|
$
|
(0.01
|
)
|
$
|
(0.00
|
)
|
||||
Weighted
average number of common shares outstanding - basic and
diluted
|
26,582,183
|
19,021,786
|
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 March 31, 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
|
26,582,183
|
2,658
|
1,128,114
|
(578,208
|
)
|
552,564
|
||||||||||
Stock-based
compensation
|
—
|
—
|
8,917
|
—
|
8,917
|
|||||||||||
Stock-based
research and development costs
|
—
|
—
|
31,000
|
—
|
31,000
|
|||||||||||
Net
loss
|
—
|
—
|
—
|
(253,103
|
)
|
(253,103
|
)
|
|||||||||
Balance,
March 31, 2007 (unaudited)
|
26,582,183
|
$
|
2,658
|
$
|
1,168,031
|
$
|
(831,311
|
)
|
$
|
339,378
|
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)
Three
Months Ended March
31,
|
Period from
August 9,
2005
(Inception)
to
March
31, 2007
|
|||||||||
2007
|
2006
|
(Cumulative)
|
||||||||
Cash
flows from operating activities
|
|
|
|
|||||||
Net
loss
|
$
|
(253,103
|
)
|
$
|
(27,099
|
)
|
$
|
(831,311
|
) | |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Depreciation
|
148
|
115
|
723
|
|||||||
Stock-based
compensation
|
8,917
|
---
|
106,317
|
|||||||
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
|
(187,387
|
)
|
(200,000
|
)
|
(237,387
|
) | ||||
Prepaid
expenses
|
7,188
|
(25,000
|
)
|
(13,177
|
) | |||||
Increase
(decrease) in -
|
||||||||||
Accounts
payable and accrued expenses
|
37,075
|
(12,802
|
)
|
68,861
|
||||||
Research
and development contract liabilities
|
213,410
|
200,000
|
213,410
|
|||||||
Estimated
liquidated damages payable under registration rights
agreement
|
---
|
---
|
74,000
|
|||||||
Net
cash used in operating activities
|
(142,752
|
)
|
(64,786
|
)
|
(587,564
|
) | ||||
|
||||||||||
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
|
|||||||
Gross
proceeds from sale of common stock
|
---
|
---
|
1,183,889
|
|||||||
Payment
of private placement offering costs
|
---
|
---
|
(214,517
|
) | ||||||
Advances
from stockholder
|
---
|
70,480
|
92,717
|
|||||||
Net
cash provided by financing activities
|
---
|
70,480
|
1,126,089
|
|||||||
|
||||||||||
Net
increase (decrease) in cash
|
(143,024
|
)
|
5,457
|
536,616
|
||||||
Cash
at beginning of period
|
679,640
|
4,946
|
---
|
|||||||
Cash
at end of period
|
$
|
536,616
|
$
|
10,403
|
$
|
536,616
|
(continued)
4
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(continued)
Three
Months Ended March
31,
|
Period from
August 9,
2005
(Inception)
to
March
31, 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)
March
31, 2007 (Unaudited) and December 31, 2006
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 period ended March 31, 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 March
31, 2007, for the three months ended March 31, 2007 and 2006, and for the period
from August 9, 2005 (Inception) to March 31, 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 March 31, 2007 and the results of its
operations and its cash flows for the three months ended March 31, 2007 and
2006, and for the period from August 9, 2005 (Inception) to March 31, 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 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.
6
2.
Business Operations and Summary of Significant Accounting
Policies
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
potential drugs and potential therapeutic agents for the treatment of specific
cancers.
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 earned 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
March 31, 2007, the Company had not yet commenced any revenue-generating
operations. All activity through March 31, 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.
7
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.
Based
on
the proceeds received from the private placement (see Note 3), the Company
may
not have sufficient resources to completely fund its planned operations for
the
next twelve months. The
strain on the Company’s limited cash resources has been further exacerbated by
the accrual of a registration penalty obligation under EITF 00-19-2 at March
31,
2007 and December 31, 2006 of $74,000 (reflecting the cash amount payable for
the registration penalty 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 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 $536,616 and working capital of $338,192 (net of the
$74,000 registration penalty obligation referred to above) at March 31, 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. In the short-term, in addition to the net proceeds from the
private placement, the Company estimates that it will require additional funding
of approximately $2,300,000. Additionally, 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 will need to fund these cash requirements from either
one
or a combination of additional financings, mergers or acquisitions, 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.
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". SFAS No. 123R superseded
APB
No. 25. 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.
8
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 during the year ended December 31, 2006.
In
addition, commencing January 1, 2006, the Company is required to recognize
the
unvested portion of the grant date fair value of awards issued prior to the
adoption of SFAS No. 123R based on the fair values previously calculated for
disclosure purposes over the remaining vesting period of the outstanding stock
options and warrants. The Company did not have any unvested outstanding stock
options or warrants at 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 March 31, 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 March 31, 2007, the Company has no accrued interest
or penalties related to uncertain tax positions.
9
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.
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. SFAS No. 159’s objective
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.
10
Research
and Development
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
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, which has been recorded as a liability at March 31, 2007
and is scheduled for payment in July 2007, 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.
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. a 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.
11
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 is required to pay
each investor prorated liquidated damages equal to 1.0% of the amount raised.
The liquidated damages are 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,
the Company determined that the registration statement covering the shares
sold
in the private placement would not be declared effective within the requisite
timeframe. As a result, the Company accrued six months liquidated damages under
the registration rights agreement aggregating approximately $74,000 as a current
liability at December 31, 2006. No further registration penalty accrual was
required at March 31, 2007. The 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.
12
Stock
Options
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 will be charged to operations ratably from July 1, 2006
through June 30, 2008. During the year ended December 31, 2006, and the three
months ended March 31, 2007, the Company recorded a charge to operations of
$31,000 and $5,167, respectively, with respect to these options.
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
will
be 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, and March 31, 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) which resulted in a charge to
operations of $7,500 during the year ended December 31, 2006 and $3,750 during
the three months ended March 31, 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, 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
March
31, 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 4.25 years.
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 December 31, 2006 and March
31,
2007 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.
13
Dr.
John
Kovach, the Company’s Chief Executive Officer, did not receive any compensation
from the Company in view of the Company’s early stage status and limited
activities. Any future compensation arrangements will be subject to the approval
of the Board of Directors.
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 is scheduled for payment in July
2007.
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 will 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 three months ended March 31, 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 60
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.
14
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OR PLAN OF
OPERATION
Forward-Looking
Statements
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.
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.
15
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 March 31, 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 beginning in 2005.
The
Company’s policy is to record interest and penalties on uncertain tax provisions
as income tax expense. As of March 31, 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.
16
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. SFAS No. 159’s objective
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.
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.
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.
17
Income
Taxes
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.
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 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 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 NIH.
18
Both
February 6, 2007 patent filings fall under the CRADA agreement with the
NINDS of the NIH. Patents resulting from these applications are jointly owned
by
Lixte and the U.S. Government. All NIH co-inventors are required to assign
their
rights to NIH. As specified in the CRADA agreement between the Company and
the
NINDS of the NIH, the Company is entitled to obtain an exclusive license from
NIH to all claims in these patents. The Company has received a draft of the
proposed exclusive patent license agreement with NIH. Under the proposed
agreement, the Company will pay a non-creditable, nonrefundable upfront fee
of
$150,000 within thirty days from the effective date of the agreement, a royalty
of 6% on net sales with a minimum annual royalty of $30,000 and royalties upon
achieving the following benchmarks: (a) $50,000 upon starting Phase I Clinical
Trials; (b) $100,000 upon starting Phase II Clinical Trials; (c) $200,000 upon
starting Phase III Clinical Trials; (d) $300,000 upon filing an IND submission;
and (e) $500,000 upon the first commercial sale. Additionally, the Company
is
required to pay royalties of 15% of the consideration received for the guaranty
of sublicensing rights. The Company intends to negotiate these economic terms
in
order to attempt to obtain more advantageous economic terms. The Company
believes that the other terms of the proposed agreement are customary for
agreements of this type.
Also
on
February 6, 2007, the Company filed a new US 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 - March 31,
2007 - Going Concern” below).
The
Company has two major goals to achieve over the next 9 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.
Goal
I: Development of More Effective Regimens for the Treatment of
GBM
Over
the
next 9 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 9 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.
19
For
several of the lead compounds, toxicity in mice was determined previously by
others and for two lead compounds, doses that are tolerable in man and the
specific toxicities induced by those doses are known. None of the lead
compounds, however, have been evaluated as potential treatments for
GBM.
Over
the
next 3-9 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 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 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 3 regimens identified under the CRADA that have never been investigated
as treatment for human GBMs. The Company expects these animal studies to be
completed in September 2007.
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 NIH and/or with a partner in the pharmaceutical industry interested in and
capable of taking the drug though the IND process and conducting clinical
evaluations.
The
Company expects to participate in clinical trials of new therapies only 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 NINDS, NIH. After completing pre-clinical evaluation,
the Company will consider partnering with NIH to conduct a phase I trial or
jointly with 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
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.
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 9 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.
20
Plans
Beyond the Next 9 Months
In
early
2008, the Company expects to be in a position to begin analyses of tumor types
other than GBM. The Company plans to establish a laboratory to proceed with
biomarker discovery independent of NIH. To do this the Company will need
approximately $2,300,000 to establish and operate the laboratory for 2 years,
i.e., to January 2010. The creation and operation of the laboratory for two
years until December 2009 will cost about $1,700,000. During this period,
patent, legal, accounting/audit and office management expenses are
estimated to be approximately $500,000. Thus, the Company will need to raise
about $2,300,000 at the end of 2007 and the beginning of 2008 to take the
next step to biomarker discovery in cancers other than GBM. Funds are
expected to come from either payments as part of licensing rights to
compounds for the treatment of GBMs or though the sale
of stock.
The
laboratory (rented space) is expected to be located in a biotechnology incubator
of the State of Maryland in close proximity to NIH or comparable incubator
near
an academic biomedical research center. This incubator offers low-cost,
high-quality space and shared resources necessary for a molecular biology
research. Because of proximity to NIH or other academic biomedical research
center, the Company will have access to many highly trained scientists and
technical personnel to staff the laboratory.
Projected
major expenses for the wet laboratory are:
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
|
Total
Costs for Laboratory Start Up and 2 Years of Operation = $1,618,400
21
Results
of Operations - Three Months Ended March 31, 2007 and 2006
The
Company is a development stage company and has not yet commenced
revenue-generating operations. Comparative financial statements for the period
ended March 31, 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.
General
and Administrative Expenses.
For the
three months ended March 31, 2007, general and administrative expenses were
$182,753, which included $8,917 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 $21,984 for
the
three months ended March 31, 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 March 31, 2007 and 2006, depreciation expense was $148 and
$115, respectively.
Research
and Development Costs.
For the
three months ended March 31, 2007, research and development costs were $74,925,
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. The Company did not have any research
and development costs for the three months ended March 31, 2006.
Reverse
Merger Costs.
In
conjunction with the reverse merger transaction completed on June 30, 2006,
WestPark Capital, Inc. was paid a non-refundable cash fee of $5,000 on March
21,
2006, which was charged to operations during the three months ended March 31,
2006.
Interest
Income.
For the
three months ended March 31, 2007, interest income was $4,723. The Company
did
not have any interest income for the three months ended March 31,
2006.
Estimated
Liquidated Damages Under Registration Rights Agreement.
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 is required to pay
each investor prorated liquidated damages equal to 1.0% of the amount raised.
The liquidated damages are 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,
the Company determined that the registration statement covering the shares
sold
in the private placement would not be declared effective within the requisite
timeframe. As a result, the Company accrued six months liquidated damages under
the registration rights agreement aggregating approximately $74,000 as a current
liability at December 31, 2006. No further registration penalty accrual was
required at March 31, 2007. The 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.
22
Net
Loss.
For the
three months ended March 31, 2007, the Company incurred a net loss of $253,103,
as compared to a net loss of $27,099 for the three months ended March 31,
2006.
Liquidity
and Capital Resources - March 31, 2007
Going
Concern
At
March
31, 2007, the Company had not yet commenced any revenue-generating operations
and were therefore considered a “development stage company”. All activity
through March 31, 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.
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.
Based
on
the proceeds received from the private placement, the Company may not have
sufficient resources to completely fund its planned operations for the next
twelve months. The
strain on the Company’s limited cash resources has been further exacerbated by
the accrual of a registration penalty obligation under EITF 00-19-2 at March
31,
2007 and December 31, 2006 of $74,000 (reflecting the cash amount payable for
the registration penalty through mid-May 2007, as described above at “Results of
Operations - Three Months Ended March 31, 2007 and 2006 - Estimated Liquidated
Damages Under Registration Rights Agreement”). If the Company does not maintain
the effectiveness of its registration statement, the Company would be subject
to
a 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
$536,616 and working capital of $338,192 (net of the $74,000 registration
penalty obligation referred to above) at March 31, 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. In the short-term, in addition to the net proceeds from the
private placement, the Company estimates that it will require additional funding
of approximately $2,300,000. Additionally, 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 will need to fund these cash requirements from either
one
or a combination of additional debt and/or equity financings, mergers or
acquisitions, or via the sale or license of certain of its assets.
23
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.
Operating
Activities.
For the
three months ended March 31, 2007, operating activities utilized cash of
$142,752, as compared to utilizing cash of $64,786 for the three months ended
March 31, 2006.
The
Company had working capital of $338,192 at March 31, 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
three months ended March 31, 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 three months ended March 31, 2007. For
the
three months ended March 31, 2006, financing activities provided net cash of
$70,480 from advances from stockholder.
Principal
Commitments
At
March
31, 2007, the Company did not have any material commitments for capital
expenditures. The Company’s principal commitments at March 31, 2007 consisted of
the estimated liquidated damages payable under the registration rights agreement
(see "Results of Operations—Three Months Ended March 31, 2007 and 2006" above)
and the contractual obligations as summarized below.
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 is scheduled for payment in July
2007.
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 will 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.
24
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 three months ended March 31, 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 60
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
March
31, 2007, the Company did not have any transactions, obligations or
relationships that could be considered off-balance sheet
arrangements.
25
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
March 31, 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 controls or in other factors that
could have significantly affected those controls during the quarter ended March
31, 2007.
26
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
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), and was charged
to operations as research and development costs during the three months ended
March 31, 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 60 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.
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.
27
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, INC.
(Registrant)
|
||
Date:
May 18, 2007
|
By: | /s/ John S. Kovach |
John S. Kovach |
||
Chief
Executive Officer and Chief Financial Officer
(Principal
financial and accounting
officer)
|
28
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.
|
|
31
|
Certifications
(1)
|
32
|
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(1)
|
(1)
Filed
herewith.
29