10QSB: Optional form for quarterly and transition reports of small business issuers
Published on November 14, 2007
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-QSB
x |
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF
1934
|
For
the
quarterly period ended September
30, 2007
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
October 31, 2007, the Company had 26,832,183 shares of common stock, $0.0001
par
value, issued and outstanding.
Transitional
Small Business Disclosure Format: Yes o
No
x
Documents
incorporated by reference: None
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(FORMERLY
SRKP 7, INC.)
INDEX
|
Page
No.
|
|
PART
I - FINANCIAL INFORMATION
|
|
|
|
|
|
Item
1. Financial Statements
|
|
|
|
|
|
Condensed
Consolidated Balance Sheets -
|
|
|
September
30, 2007 (Unaudited) and December 31, 2006 (Restated)
|
4
|
|
|
|
|
Condensed
Consolidated Statements of Operations (Unaudited) -
|
|
|
Three
Months Ended September 30, 2007 and 2006, Nine Months Ended September
30,
2007 and 2006, and August 9, 2005 (Inception) to September 30, 2007
(Cumulative)
|
5
|
|
|
|
|
Condensed
Consolidated Statement of Changes in Stockholders’ Equity (Deficiency)
(Unaudited) -
|
|
|
August 9,
2005 (Inception) to September 30, 2007
|
6
|
|
|
|
|
Condensed
Consolidated Statements of Cash Flows (Unaudited) -
|
|
|
Nine
Months Ended September 30, 2007 and 2006, and August 9, 2005
(Inception) to
September
30, 2007 (Cumulative)
|
7
|
|
|
|
|
Notes
to Condensed Consolidated Financial Statements -
|
|
|
September
30, 2007 (Unaudited) and December 31, 2006 (Restated)
|
9
|
|
|
|
|
Item
2. Management’s Discussion and Analysis or Plan of
Operation
|
20
|
|
|
|
|
Item
3. Controls and Procedures
|
30
|
|
PART
II - OTHER INFORMATION
|
||
Item
1 Legal
Proceedings
|
31
|
|
Item
2 Unregistered
Sales of Equity Securities and Use of Proceeds
|
31
|
|
Item
3 Defaults
Upon Senior Securities
|
31
|
|
Item
4 Submission
of Matters to a Vote of Security Holders
|
32
|
|
Item
5 Other
Information
|
32
|
|
Item
6 Exhibits
|
32
|
|
SIGNATURES
|
33
|
2
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.
3
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
September
30,
2007
(Unaudited)
|
December
31,
2006
(Restated)
|
|||||
ASSETS
|
|
|
|||||
Current
assets:
|
|
|
|||||
Cash
and cash equivalents
|
$
|
124,069
|
$
|
679,640
|
|||
Advances
on research and development contract services
|
124,963
|
50,000
|
|||||
Prepaid
insurance
|
22,828
|
20,365
|
|||||
Total
current assets
|
271,860
|
750,005
|
|||||
Office
equipment,
net of accumulated depreciation of $1,019 at
September
30, 2007 and $575 at December 31, 2006
|
890
|
1,062
|
|||||
Total
assets
|
$
|
272,750
|
$
|
751,067
|
|||
|
|||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
37,931
|
$
|
31,786
|
|||
Liquidated
damages payable under registration rights agreement
|
74,000
|
74,000
|
|||||
Research
and development contract liabilities
|
38,335
|
---
|
|||||
Due
to stockholder
|
92,717
|
92,717
|
|||||
Total
current liabilities
|
242,983
|
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 -
26,832,183
shares at September 30, 2007 and 26,582,183 shares at
December
31, 2006
|
2,683
|
2,658
|
|||||
Additional
paid-in capital
|
1,955,321
|
1,128,114
|
|||||
Deficit
accumulated during the development stage
|
(1,927,987
|
)
|
(578,208
|
)
|
|||
30,017
|
552,564
|
||||||
Less
receivable from sale of common stock
|
(250
|
)
|
---
|
||||
Total
stockholders’ equity
|
29,767
|
552,564
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
272,750
|
$
|
751,067
|
See
accompanying notes to condensed consolidated financial statements.
4
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
|
Three
Months Ended
September 30,
|
Nine
Months Ended
September 30,
|
Period from
August 9,
2005
(Inception)
to
September 30,
2007
|
|||||||||||||
|
2007
|
2006
|
2007
|
2006
|
(Cumulative)
|
|||||||||||
Revenues
|
$
|
---
|
$
|
---
|
$
|
---
|
$
|
---
|
$
|
---
|
||||||
|
||||||||||||||||
Costs
and expenses:
|
||||||||||||||||
General
and administrative,
including
$773,356 and $8,917 of
stock-based
compensation during
the
three months ended September
30,
2007 and 2006, $791,064 and
$88,483
during the nine months
ended
September 30, 2007 and
2006,
respectively, and $888,464
for
the period from August 9, 2005
(inception)
to September 30, 2007
(cumulative)
|
853,075
|
65,251
|
1,109,061
|
201,104
|
1,424,492
|
|||||||||||
Depreciation
|
148
|
115
|
444
|
344
|
1,019
|
|||||||||||
Research
and development costs,
including
$4,918 of stock-based
expense
during the three months
ended
September 30, 2007,
$35,918
for the nine months ended
September
30, 2007 and the period
from
August 9, 2005 inception) to
September
30, 2007 (cumulative)
|
68,593
|
50,100
|
249,443
|
100,100
|
399,543
|
|||||||||||
Reverse
merger costs
|
---
|
---
|
---
|
50,000
|
50,000
|
|||||||||||
Total
costs and expenses
|
921,816
|
115,466
|
1,358,948
|
351,548
|
1,875,054
|
|||||||||||
|
(921,816
|
)
|
(115,466
|
)
|
(1,358,948
|
)
|
(351,548
|
)
|
(1,875,054
|
)
|
||||||
Interest
income
|
862
|
6,588
|
9,169
|
6,588
|
21,067
|
|||||||||||
Liquidated
damages under
registration
rights agreement
|
---
|
---
|
---
|
---
|
(74,000
|
)
|
||||||||||
Net
loss
|
$
|
(920,954
|
)
|
$
|
(108,878
|
)
|
$
|
(1,349,779
|
)
|
$
|
(344,960
|
)
|
$
|
(1,927,987
|
)
|
|
Net
loss per common share -
basic
and diluted
|
$
|
(0.03
|
)
|
$
|
(0.00
|
)
|
$
|
(0.05
|
)
|
$
|
(0.02
|
)
|
||||
Weighted
average number of
common
shares outstanding -
basic
and diluted
|
26,612,403
|
26,135,279
|
26,592,256
|
21,440,909
|
See
accompanying notes to condensed consolidated financial statements.
5
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 September 30, 2007
|
Common
Stock
|
Additional
Paid-in
|
Deficit
Accumulated
During
the
Development
|
Receivable
from
Sale
of
Common
|
Total
Stockholders’
Equity
|
||||||||||||||
|
Shares
|
Amount
|
Capital
|
Stage
|
Stock
|
(Deficiency)
|
|||||||||||||
|
|
|
|
|
|
||||||||||||||
Balance,
August 9, 2005
(inception)
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||
Shares
issued to founding
stockholder
|
19,021,786
|
1,902
|
(402
|
)
|
—
|
—
|
1,500
|
||||||||||||
Net
loss for the period
August
9, 2005 (inception)
to
December 31, 2005
|
—
|
—
|
—
|
(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 for the year
|
—
|
—
|
—
|
(562,084
|
)
|
—
|
(562,084
|
)
|
|||||||||||
Balance,
December 31,
2006
(Restated)
|
26,582,183
|
2,658
|
1,128,114
|
(578,208
|
)
|
—
|
552,564
|
||||||||||||
Stock-based
compensation
|
250,000
|
25
|
791,289
|
—
|
(250
|
)
|
791,064
|
||||||||||||
Stock-based
research and
development
costs
|
—
|
—
|
35,918
|
—
|
—
|
35,918
|
|||||||||||||
Net
loss for the nine months
ended
September 30, 2007
|
—
|
—
|
—
|
(1,349,779
|
)
|
—
|
(1,349,779
|
)
|
|||||||||||
Balance,
September 30,
2007
(Unaudited)
|
26,832,183
|
$
|
2,683
|
$
|
1,955,321
|
$
|
(1,927,987
|
)
|
$
|
(250
|
)
|
$
|
29,767
|
See
accompanying notes to condensed consolidated financial statements.
6
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
|
Nine
Months Ended
September
30,
|
Period from
August 9,
2005
(Inception)
to
September
30, 2007
|
||||||||
|
2007
|
2006
|
(Cumulative)
|
|||||||
|
|
|
|
|||||||
Cash
flows from operating activities
|
|
|
|
|||||||
Net
loss
|
$
|
(1,349,779
|
)
|
$
|
(344,960
|
)
|
$
|
(1,927,987
|
)
|
|
Adjustments
to reconcile net loss to net cash used in
operating
activities:
|
||||||||||
Depreciation
|
444
|
344
|
1,019
|
|||||||
Stock-based
compensation
|
791,064
|
88,483
|
888,464
|
|||||||
Stock-based
research and development costs
|
35,918
|
---
|
35,918
|
|||||||
Changes
in operating assets and liabilities:
|
||||||||||
(Increase)
decrease in -
|
||||||||||
Advances
on research and development contract services
|
(74,963
|
)
|
(100,000
|
)
|
(124,963
|
)
|
||||
Prepaid
expenses
|
(2,463
|
)
|
(27,552
|
)
|
(22,828
|
)
|
||||
Increase
(decrease) in -
|
||||||||||
Accounts
payable and accrued expenses
|
6,145
|
2,579
|
37,931
|
|||||||
Research
and development contract liabilities
|
38,335
|
---
|
38,335
|
|||||||
Liquidated
damages payable under registration rights
agreement
|
---
|
---
|
74,000
|
|||||||
Net
cash used in operating activities
|
(555,299
|
)
|
(381,106
|
)
|
(1,000,111
|
)
|
||||
|
||||||||||
Cash
flows from investing activities
|
||||||||||
Purchase
of office equipment
|
(272
|
)
|
(238
|
)
|
(1,909
|
)
|
||||
Net
cash used in investing activities
|
(272
|
)
|
(238
|
)
|
(1,909
|
)
|
||||
|
||||||||||
Cash
flows from financing activities
|
||||||||||
Proceeds
from sale of common stock to founder
|
---
|
---
|
1,500
|
|||||||
Cash
acquired in reverse merger transaction
|
---
|
62,500
|
62,500
|
|||||||
Gross
proceeds from sale of common stock
|
---
|
1,183,889
|
1,183,889
|
|||||||
Payment
of private placement offering costs
|
---
|
(233,025
|
)
|
(214,517
|
)
|
|||||
Advances
from stockholder
|
---
|
86,771
|
92,717
|
|||||||
Net
cash provided by financing activities
|
---
|
1,100,135
|
1,126,089
|
|||||||
|
||||||||||
Net
increase (decrease) in cash
|
(555,571
|
)
|
718,791
|
124,069
|
||||||
Cash
at beginning of period
|
679,640
|
4,946
|
---
|
|||||||
Cash
at end of period
|
$
|
124,069
|
$
|
723,737
|
$
|
124,069
|
(continued)
7
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(continued)
Nine
Months Ended
September
30,
|
Period from
August 9,
2005
(Inception)
to
September
30, 2007
|
|||||||||
|
2007
|
2006
|
(Cumulative)
|
|||||||
|
|
|
|
|||||||
Supplemental
disclosures of cash flow information:
|
|
|
|
|||||||
Cash
paid for -
|
|
|
|
|||||||
Interest
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
Income
taxes
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
Supplemental
schedule of non-cash financing activities:
|
||||||||||
Receivable
from sale of common stock to consultant
|
$
|
250
|
$
|
—
|
$
|
250
|
See
accompanying notes to condensed consolidated financial statements.
8
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(FORMERLY
SRKP 7, INC.)
AND
SUBSIDIARY
(a
development stage company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
September
30, 2007 (Unaudited) and December 31, 2006 (Restated)
1.
Organization and Basis of Presentation
On
June
30, 2006, Lixte Biotechnology, Inc., a privately-held Delaware corporation
(“Lixte”), completed a reverse merger transaction with SRKP 7, Inc. (“SRKP”), a
public “shell” company, whereby Lixte became a wholly-owned subsidiary of SRKP.
For financial reporting purposes, Lixte was considered the accounting acquirer
in the merger and the merger was accounted for as a reverse merger. Accordingly,
the historical financial statements presented herein are those of Lixte and
do
not include the historical financial results of SRKP. The stockholders’ equity
section of SRKP has been retroactively restated for all periods presented to
reflect the accounting effect of the reverse merger transaction. All costs
associated with the reverse merger transaction were expensed as incurred.
Comparative financial statements for the periods ended June 30, 2006 reflect
the
results of operations of Lixte, the accounting acquirer in the reverse merger
transaction. Unless the context indicates otherwise, SRKP and Lixte are
hereinafter referred to as the “Company”. On December 7, 2006, the Company
amended its Certificate of Incorporation to change its name from SRKP 7, Inc.
to
Lixte Biotechnology Holdings, Inc. (“Holdings”).
The
accompanying condensed consolidated financial statements include the financial
statements of Holdings and its wholly-owned subsidiary, Lixte. All intercompany
balances and transactions have been eliminated in consolidation.
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities at the date of the financial statements and the reported amounts
of
expenses during the reporting period. Actual results could differ from those
estimates.
The
condensed consolidated financial statements of Lixte (the “Company”) at
September 30, 2007, for the three months and nine months ended September 30,
2007 and 2006, and for the period from August 9, 2005 (Inception) to
September 30, 2007 (cumulative), are unaudited. In the opinion of management,
all adjustments (including normal recurring adjustments) have been made that
are
necessary to present fairly the financial position of the Company as of
September 30, 2007 and the results of its operations for the three months and
nine months ended September 30, 2007 and 2006, and for the period from
August 9, 2005 (Inception) to September 30, 2007 (cumulative), and its cash
flows for the nine months ended September 30, 2007 and 2006, and for the period
from August 9, 2005 (Inception) to September 30, 2007 (cumulative).
Operating results for the interim periods presented are not necessarily
indicative of the results to be expected for a full fiscal year. The condensed
consolidated balance sheet at December 31, 2006 (Restated) has been derived
from
the Company’s audited financial statements (as restated) as of that
date.
The
statements and related notes have been prepared pursuant to the rules and
regulations of the U.S. Securities and Exchange Commission. Accordingly, certain
information and footnote disclosures normally included in financial statements
prepared in accordance with generally accepted accounting principles have been
omitted pursuant to such rules and regulations. These financial statements
should be read in conjunction with the financial statements and other
information included in the Company’s Annual Report on Form 10-KSB, as amended,
as filed with the U.S. Securities and Exchange Commission on May 17,
2007.
9
Nature
of Operations
Lixte
was
incorporated in Delaware on August 9, 2005 to capitalize on opportunities to
develop low cost, specific and sensitive tests for the early detection of
cancers to better estimate prognosis, to monitor treatment response, and to
reveal targets for development of more effective treatments.
The
Company’s initial focus is on developing new treatments for the most common and
most aggressive type of primary brain cancer, glioblastoma multiforme (“GBM”).
Lixte entered into a Cooperative Research and Development Agreement (“CRADA”)
with the National Institute of Neurological Diseases and Stroke (“NINDS”) of the
National Institutes of Health (“NIH”) to identify and evaluate drugs that target
a specific biochemical pathway for GBM cell differentiation. The CRADA also
covers research to determine whether expression of a component of this pathway
correlates with prognosis in glioma patients.
The
Company expects that its products will derive directly from its intellectual
property, which will consist of patents that it anticipates will arise out
of
its research activities. These patents are expected to cover biomarkers uniquely
associated with the specific types of cancer, patents on methods to identify
drugs that inhibit growth of specific tumor types, and combinations of drugs
and
other potential therapeutic agents for the treatment of specific
cancers.
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 has not yet commenced any revenue-generating
operations, does not have any cash flows from operations, and is dependent
on
debt and equity funding to finance its operations. The Company has selected
December 31 as its fiscal year-end.
Going
Concern and Plan of Operations
The
Company’s financial statements have been presented on the basis that it is a
going concern, which contemplates the realization of assets and satisfaction
of
liabilities in the normal course of business. The Company is in the development
stage and has not generated any revenues from operations to date, which raises
substantial doubt about its ability to continue as a going concern.
The
Company’s ability to continue as a going concern is dependent upon its ability
to develop additional sources of capital, and ultimately achieve profitable
operations. The accompanying financial statements do not include any adjustments
that might result from the outcome of these uncertainties.
At
September 30, 2007, the Company had not yet commenced any revenue-generating
operations. All activity through September 30, 2007 related to the Company’s
formation, capital raising efforts and initial research and development
activities. As such, the Company has yet to generate any cash flows from
operations, and is essentially dependent on debt and equity funding from both
related and unrelated parties to finance its operations. Prior to June 30,
2006,
the Company’s cash requirements were funded by advances from Lixte’s founder. On
June 30, 2006, the Company completed an initial closing of its private placement
(see Note 3), selling 1,973,869 shares of common stock at a price of $0.333
per
share and receiving net proceeds of $522,939. On July 27, 2006, the Company
completed a second closing of its private placement, selling 1,581,351 shares
of
common stock at a price of $0.333 per share and receiving net proceeds of
$446,433.
10
The
Company does not currently have sufficient resources to fully fund its planned
operations for the next twelve months. The strain on the Company’s limited cash
resources has been further exacerbated by the registration penalty obligation
of
$74,000 (originally recorded at December 31, 2006 pursuant to EITF 00-19-2),
reflecting the cash amount currently payable to the investors in the private
placement for the registration penalty accrued through mid-May 2007, as
described at Note 3. If the Company does not maintain the effectiveness of
its
registration statement, the Company would be subject to a further registration
penalty at the rate of approximately $12,000 per 30-day period thereafter,
continuing through July 2008. Since the Company only has cash of $124,069 and
working capital of $28,877 (including the effect from the $74,000 registration
penalty obligation referred to above) at September 30, 2007, this short-term
cash obligation and the uncertainty related to it could have a material adverse
impact on the Company’s ability to fund its business plan and conduct
operations.
The
Company does not have sufficient resources to fully develop and commercialize
any products that may arise from its research. Accordingly, the Company will
need to raise additional funds in order to satisfy its future working capital
requirements. Based on the Company’s updated and revised operating budget, the
Company estimates that it will require approximately $600,000 of additional
funding through December 31, 2008. Thereafter, the Company currently estimates
that it will require an additional $2,000,000 to fund future operations,
including the possible establishment of a laboratory, depending on the
availability of capital and various operating developments. The amount and
timing of future cash requirements will depend on market acceptance of the
Company’s products, if any, and the resources that the Company devotes to
developing and supporting its products. The Company anticipates funding these
cash requirements from debt or equity financings, mergers or acquisitions,
and/or via the sale or license of its intellectual properties.
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 resources 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". Effective January 1, 2006,
SFAS No. 123R requires that the Company measure the cost of employee services
received in exchange for equity awards based on the grant date fair value of
the
awards, with the cost to be recognized as compensation expense in the Company’s
financial statements over the vesting period of the awards.
The
Company adopted SFAS No. 123R effective January 1, 2006, and is using the
modified prospective method in which compensation cost is recognized beginning
with the effective date (a) based on the requirements of SFAS No. 123R for
all
share-based payments granted after the effective date and (b) based on the
requirements of SFAS No. 123R for all awards granted to employees prior to
the
effective date of SFAS No. 123R that remain unvested on the effective date.
Accordingly, the Company recognizes compensation cost for equity-based
compensation for all new or modified grants issued after December 31, 2005.
The
Company did not have any modified grants subsequent to December 31,
2005.
11
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
de-recognition, 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 September 30, 2007, no liability for unrecognized
tax benefits was required to be recorded.
The
Company files income tax returns in the U.S. federal jurisdiction and various
states. The Company is subject to U.S. federal or state income tax examinations
by tax authorities for years after 2004.
The
Company’s policy is to record interest and penalties on uncertain tax provisions
as income tax expense. As of September 30, 2007, the Company has no accrued
interest or penalties related to uncertain tax positions.
12
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. The objective of SFAS No.
159 is to reduce both complexity in accounting for financial instruments and
the
volatility in earnings caused by measuring related assets and liabilities
differently. Generally accepted accounting principles have required different
measurement attributes for different assets and liabilities that can create
artificial volatility in earnings. SFAS No. 159 helps to mitigate this type
of
accounting-induced volatility by enabling companies to report related assets
and
liabilities at fair value, which would likely reduce the need for companies
to
comply with detailed rules for hedge accounting. SFAS No. 159 also establishes
presentation and disclosure requirements designed to facilitate comparisons
between companies that choose different measurement attributes for similar
types
of assets and liabilities. SFAS No. 159 requires companies to provide additional
information that will help investors and other users of financial statements
to
more easily understand the effect of the company’s choice to use fair value on
its earnings. SFAS No. 159 also requires companies to display the fair value
of
those assets and liabilities for which the company has chosen to use fair value
on the face of the balance sheet. SFAS No. 159 does not eliminate disclosure
requirements included in other accounting standards, including requirements
for
disclosures about fair value measurements included in SFAS No. 157 and SFAS
No.
107. SFAS No. 159 is effective as of the beginning of a company’s first fiscal
year beginning after November 15, 2007. Early adoption is permitted as of the
beginning of the previous fiscal year provided that the company makes that
choice in the first 120 days of that fiscal year and also elects to apply the
provisions of SFAS No. 157. The Company is currently assessing the potential
effect of SFAS No. 159 on its consolidated financial statements.
Other
than the foregoing, management does not believe that any other recently issued,
but not yet effective, accounting standards, if currently adopted, would have
a
material effect on the Company's financial statements.
Loss
Per Common Share
Loss
per
common share is computed by dividing net loss by the weighted average number
of
shares of common stock outstanding during the respective periods. Basic and
diluted loss per common share are the same for all periods presented because
all
warrants and stock options outstanding are anti-dilutive. The 19,021,786 shares
of common stock issued to the founder of Lixte in conjunction with the closing
of the reverse merger transaction on June 30, 2006 have been presented as
outstanding for all periods presented.
Research
and development costs are expensed as incurred. Research and development
expenses consist primarily of fees paid to consultants and outside service
providers, and other expenses relating to the acquisition, design, development
and testing of the Company's treatments and product
candidates.
13
Amounts
due, pursuant to contractual commitments, on research and development contracts
with third parties are recorded as a liability, with the related amount of
such
contracts recorded as advances on research and development contract services
on
the Company’s balance sheet. Such advances on research and development contract
services are expensed over their life on the straight-line basis, unless the
achievement of milestones, the completion of contracted work, or other
information indicates that a different expensing schedule is more appropriate.
The Company accounts for its research and development contracts in accordance
with EITF 07-3.
The
funds paid to NINDS of the NIH, pursuant to the CRADA effective March 22,
2006, represent an advance on research and development costs and therefore
have
future economic benefit. As such, such costs are being charged to expense when
they are actually expended by the provider, which is, effectively, as they
perform the research activities that they are contractually committed to
provide. Absent information that would indicate that a different expensing
schedule is more appropriate (such as, for example, from the achievement of
performance milestones or the completion of contract work), such advances are
being expensed over the contractual service term on a straight-line basis,
which
reflects a reasonable estimate of when the underlying research and development
costs are being incurred. The Company’s $200,000 financial obligation due under
the CRADA as of March 22, 2007, was paid on June 29, 2007, and is intended
to
fund ongoing research and development activities through June 2008.
Patent
Costs
Due
to the significant uncertainty associated with the successful development
of one or more commercially viable products based on the Company's research
efforts and any related patent applications, all patent costs are expensed
as
incurred. Patent costs were $19,500 and $5,000 for the three months ended
September 30, 2007 and 2006, respectively, $66,092 and $33,064 for the nine
months ended September 30, 2007 and 2006, respectively, and $132,769 for the
period from August 9, 2005 (inception) to September 30, 2007 (cumulative).
Patent costs are included in general and administrative expense in the Company's
statement of operations.
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. an aggregate cash fee of $50,000.
14
Private
Placement
On
June 30, 2006, concurrently with the closing of the Exchange, the Company sold
an aggregate of 1,973,869 shares of its common stock to 26 accredited investors
in an initial closing of its private placement at a per share price of $0.333,
resulting in aggregate gross proceeds to the Company of $657,299. The Company
paid to WestPark Capital, Inc., as placement agent, a commission of 10% and
a
non-accountable fee of 4% of the gross proceeds of the private placement and
issued five-year warrants to purchase common stock equal to (a) 10% of the
number of shares sold in the private placement exercisable at $0.333 per share
and (b) an additional 2% of the number of shares sold in the private placement
also exercisable at $0.333 per share. A total of 236,864 warrants were issued.
Net cash proceeds to the Company, after the deduction of all private placement
offering costs and expenses, were $522,939.On
July
27, 2006, the Company sold an aggregate of 1,581,351 shares of its common stock
to 31 accredited investors in a second closing of the private placement at
a per
share price of $0.333 resulting in aggregate gross proceeds to the Company
of
$526,590. The Company paid to WestPark Capital, Inc., as placement agent, a
commission of 10% and a non-accountable fee of 4% of the gross proceeds of
the
private placement and issued five-year warrants to purchase common stock equal
to (a) 10% of the number of shares sold in the private placement exercisable
at
$0.333 per share and (b) an additional 2% of the number of shares sold in the
private placement also exercisable at $0.333 per share. A total of 189,762
warrants were issued. Net cash proceeds to the Company were
$446,433.
In
conjunction with the private placement of common stock, the Company issued
a
total of 426,626 five-year warrants to WestPark Capital, Inc. exercisable at
the
per share price of the common stock sold in the private placement ($0.333 per
share). The warrants issued to WestPark Capital, Inc. do not contain any price
anti-dilution provisions. However, such warrants contain cashless exercise
provisions and demand registration rights, but the warrant holder has agreed
to
waive any claims to monetary damages or financial penalties for any failure
by
the Company to comply with such registration requirements. Based on the
foregoing, the warrants have been accounted for as equity.
The
fair
value of the warrants, as calculated pursuant to the Black-Scholes
option-pricing model, was determined to be $132,254 ($0.31 per share) using
the
following Black-Scholes input variables: stock price on date of grant - $0.333;
exercise price - $0.333; expected life - 5 years; expected volatility - 150%;
expected dividend yield - 0%; risk-free interest rate - 5%.
As
part
of the Company’s private placement of its securities completed on July 27, 2006,
the Company entered into a registration rights agreement with the purchasers,
whereby the Company agreed to register the shares of common stock sold in the
private placement, and to maintain the effectiveness of such registration
statement, subject to certain conditions. The agreement required the Company
to
file a registration statement within 45 days of the closing of the private
placement and to have the registration statement declared effective within
120
days of the closing of the private placement. Since the registration statement
was not declared effective by the Securities and Exchange Commission within
120
days of the closing of the private placement, the Company was required to pay
each investor prorated liquidated damages equal to 1.0% of the amount raised
per
month, payable monthly in cash. On September 8, 2006, the Company filed a
registration statement on Form SB-2 to register 3,555,220 shares of the common
stock sold in the private placement.
In
accordance with EITF 00-19-2, “Accounting for Registration Payment
Arrangements”, on the date of the closing of the private placement, the Company
believed it would meet the deadlines under the registration rights agreement
with respect to filing a registration statement and having it declared effective
by the SEC. As a result, the Company did not record any liabilities associated
with the registration rights agreement at June 30, 2006. At December 31, 2006
(Restated), the Company determined that the registration statement covering
the
shares sold in the private placement would not be declared effective within
the
requisite time frame. As a result, the Company has accrued six months liquidated
damages under the registration rights agreement aggregating approximately
$74,000 as a current liability at September 30, 2007 and December 31, 2006
(Restated). No further registration penalty accrual was required at September
30, 2007, as the Company’s registration statement on Form SB-2 was declared
effective by the Securities and Exchange Commission on May 14, 2007. The Company
will continue to review the status of the registration statement at each quarter
end in the future and record further liquidated damages under the registration
rights agreement as necessary. As of September 30, 2007, the Company had not
yet
paid the registration penalty to the investors.
15
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 September 30, 2007 and December
31, 2006 (Restated), stockholder advances totaled $92,717.
The
Company’s office facilities have been provided without charge by the Company’s
founding stockholder and Chief Executive Officer. Such costs were not material
to the financial statements and, accordingly, have not been reflected
therein.
Dr.
John
Kovach, the Company’s Chief Executive Officer, is involved in other business
activities and may, in the future, become involved in other business
opportunities that become available. Accordingly, the Chief Executive Officer
may face a conflict in selecting between the Company and his other business
interests. The Company has not yet formulated a policy for the resolution of
such potential conflicts.
5.
Common Stock and Preferred Stock
The
Company’s Certificate of Incorporation provides for authorized capital of
110,000,000 shares, of which 100,000,000 shares are common stock with a par
value of $0.0001 per share and 10,000,000 shares are preferred stock with a
par
value of $0.0001 per share.
The
Company is authorized to issue 10,000,000 shares of preferred stock with such
designations, voting and other rights and preferences, as may be determined
from
time to time by the Board of Directors.
6.
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 is being charged to operations ratably
from
July 1, 2006 through June 30, 2008. During the year ended December 31, 2006
(Restated), the three months ended September 30, 2007, and the nine months
ended
September 30, 2007, the Company recorded a charge to operations of $31,000,
$5,167 and $15,500, 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.
16
On
June
30, 2006, effective with the closing of the Exchange, the Company granted to
certain members of its Scientific Advisory Committee stock options to purchase
an aggregate of 100,000 shares of common stock exercisable for a period of
five
years at $0.333 per share, with one-half of the options vesting annually on
each
of June 30, 2007 and June 30, 2008. The fair value of these options, as
calculated pursuant to the Black-Scholes option-pricing model, was initially
determined to be $31,000 ($0.31 per share). The fair value of such options
is
being charged to operations ratably from July 1, 2006 through June 30, 2008.
On
December 31, 2006 (Restated), and September 30, 2007, the fair value of these
options, as calculated pursuant to the Black-Scholes option-pricing model,
was
determined to be $30,000 ($0.30 per share) and $98,000 ($0.98 per share),
respectively, which resulted in a charge to operations of $7,500 during the
year
ended December 31, 2006 (Restated), $12,316 during the three months ended
September 30, 2007, and $19,691 during the nine months ended September 30,
2007.
On
June
20, 2007, the Board of Directors of the Company approved the 2007 Stock
Compensation Plan (the “2007 Plan”), which provides for the granting of awards,
consisting of common stock options, stock appreciation rights, performance
shares, or restricted shares of common stock, to employees and independent
contractors, for up to 2,500,000 shares of the Company’s common stock, under
terms and condition, as determined by the Company’s Board of Directors. On
September 12, 2007, pursuant to the 2007 Plan, the Company granted to Dr.
Stephen Carter, stock options to purchase an aggregate of 200,000 shares of
common stock, exercisable for a period of five years from vesting date at $0.333
per share, with one-half (100,000 shares) vesting annually on each of September
12, 2008 and 2009. The fair value of these options, as calculated pursuant
to
the Black-Scholes option-pricing model, was determined to be $204,000 ($1.02
per
share), which is being charged to operations ratably from September 12, 2007
through September 12, 2009. During the three months and the nine months ended
September 30, 2007, the Company recorded a charge to operations of $5,016 with
respect to these options.
On
September 12, 2007, the Company entered into a consulting agreement with Gil
Schwartzberg and granted to Mr. Schwartzberg stock options to purchase an
aggregate of 1,000,000 shares of common stock, exercisable for a period of
four
years from vesting date at $1.00 per share, with one-half of the options
(500,000 shares) vesting immediately and one-half (500,000 share) vesting on
September 12, 2008. The fair value of these options, as calculated pursuant
to
the Black-Scholes option-pricing model, was determined to be $945,000 ($0.945
per share), of which $465,000 was charged to operations on September 12, 2007,
and the remaining $480,000 is being charged to operations ratably from September
12, 2007 through September 12, 2008. During the three months and the nine months
ended September 30, 2007, the Company recorded a charge to operations of
$488,607 with respect to these options.
On
September 12, 2007, the Company entered into a consulting agreement with Francis
Johnson and granted to Professor Johnson stock options to purchase an aggregate
of 300,000 shares of common stock, exercisable for a period of four years from
vesting date at $0.333 per share, with one-third (100,000 shares) vesting
annually on each of September 12, 2008, 2009 and 2010. The fair value of these
options, as calculated pursuant to the Black-Scholes option-pricing model,
was
determined to be $300,000 ($1.00 per share), which is being charged to
operations ratably from September 12, 2007 through September 12, 2010. During
the three months and the nine months ended September 30, 2007, the Company
recorded a charge to operations of $4,918, with respect to these
options.
In
accordance with EITF 96-18, options granted to committee members and outside
consultants are valued each reporting period to determine the amount to be
recorded as an expense in the respective period. As the options vest, they
will
be valued one final time on each vesting date and an adjustment will be recorded
for the difference between the value already recorded and the then current
value
on the date of vesting.
On
June
30, 2006, the fair value of the aforementioned stock options was initially
calculated using the following Black-Scholes input variables: stock price on
date of grant - $0.333; exercise price - $0.333; expected life - 5 years;
expected volatility - 150%; expected dividend yield - 0%; risk-free interest
rate - 5%. On December 31, 2006 (Restated), the Black-Scholes input variables
utilized to determine the fair value of the aforementioned stock options were
deemed to be the same as at June 30, 2006, except for an expected life of 4.5
years. On September 30, 2007, the fair value of the aforementioned stock options
was calculated using the following Black-Scholes input variables: stock price
on
date of grant - $1.05; exercise price - $0.333 to $1.00; expected life - 3.75
to
6 years; expected volatility - 150%; expected dividend yield - 0%; risk-free
interest rate - 5%.
17
7.
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 27 months, as amended, from the effective date and may be
unilaterally terminated by either party by providing written notice within
sixty
days. The CRADA provides for the collaboration between the parties in the
identification and evaluation of agents that target the Nuclear Receptor
CoRepressor (N-CoR) pathway for glioma cell differentiation. The CRADA also
provided that NINDS and Lixte will conduct research to determine if expression
of N-CoR correlates with prognosis in glioma patients. Pursuant to the CRADA,
Lixte agreed to provide funds under the CRADA in the amount of $200,000 per
year
to fund two technical assistants for the technical, statistical and
administrative support for the research activities, as well as to pay for
supplies and travel expenses. The first installment of $200,000 was due within
180 days of the effective date and was paid in full on July 6, 2006. The second
installment of $200,000 was paid in full on June 29, 2007. The CRADA was
extended to June 30, 2008 from March 2008 at no additional cost as the funds
provided by the Company will support the collaboration at least until that
date.
On
January 5, 2007, Lixte entered into a Services Agreement with The Free State
of
Bavaria (Germany) represented by the University of Regensburg (the “University”)
pursuant to which Lixte retained the University to provide to it certain samples
of primary cancer tissue and related biological fluids to be obtained from
patients afflicted with specified types of cancer. The University will also
provide certain information relating to such patients. Lixte
agreed to pay the University 72,000 Euros in two equal installments. The first
installment of 36,000 Euros ($48,902) was paid on March 7, 2007, and the second
installment of 36,000 Euros (approximately $51,380 at September 30, 2007) 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 nine months ended September 30, 2007, since
the
option was fully vested and non-forfeitable on the date of issuance. Lixte
has the right to terminate the Agreement at any time during the term of the
Agreement upon sixty days prior written notice. On February 5, 2009,
provided that the Agreement has not been terminated prior to such date, the
Company agreed to grant Chem-Master a second five-year option to purchase
an additional 100,000 shares of the Company’s common stock at an exercise price
of $0.333 per share.
On
September 12, 2007, the Company entered into two consulting agreements for
financial or scientific services. Compensation related to these agreements
is
primarily in the form of stock options (see Note 6).
18
On
September 20, 2007, the Company entered into a one-year consulting agreement
(the “Agreement”) with Mirador Consulting, Inc. (“Mirador”), pursuant to which
Mirador is to provide the Company with various financial services. Pursuant
to
the Agreement, Lixte agreed to pay Mirador $5,000 per month and also agreed
to
sell Mirador 250,000 shares of the Company’s restricted common stock for $250
($0.001 per share). The fair value of this transaction was determined to be
in
excess of the purchase price by $262,250 ($1.049 per share), reflecting the
difference between the $0.001 purchase price and the $1.05 price per share
as
quoted on the OTC Bulletin Board, and was charged to operations as stock-based
compensation during the three months and nine months ended September 30,
2007.
On
September 27, 2007, the Company entered into an agreement with Southern Research
Institute (“Southern”), pursuant to which Southern agreed to conduct certain
scientific studies. The studies are expected to be completed by November 1,
2007
at a total cost of $22,710.
19
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.
20
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 September 30, 2007, the Company has no accrued
interest or penalties related to uncertain tax positions.
Recent
Accounting Pronouncements
In
September 2006, the FASB issued Statement of Financial Accounting Standards
No.
157, “Fair Value Measurements” (“SFAS No. 157”), which establishes a formal
framework for measuring fair value under generally accepted accounting
principles. SFAS No. 157 defines and codifies the many definitions of fair
value
included among various other authoritative literature, clarifies and, in some
instances, expands on the guidance for implementing fair value measurements,
and
increases the level of disclosure required for fair value measurements. Although
SFAS No. 157 applies to and amends the provisions of existing FASB and AICPA
pronouncements, it does not, of itself, require any new fair value measurements,
nor does it establish valuation standards. SFAS No. 157 applies to all other
accounting pronouncements requiring or permitting fair value measurements,
except for: SFAS No. 123R, share-based payment and related pronouncements,
the
practicability exceptions to fair value determinations allowed by various other
authoritative pronouncements, and AICPA Statements of Position 97-2 and 98-9
that deal with software revenue recognition. SFAS No. 157 is effective for
financial statements issued for fiscal years beginning after November 15, 2007,
and interim periods within those fiscal years. The Company is currently
assessing the potential effect of SFAS No. 157 on its consolidated financial
statements.
21
Other
than the foregoing, 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. Research and development
expenses consist primarily of fees paid to consultants and outside service
providers, and other expenses relating to the acquisition, design, development
and testing of the Company's treatments and product
candidates.
Amounts
due, pursuant to contractual commitments, on research and development contracts
with third parties are recorded as a liability, with the related amount of
such
contracts recorded as advances on research and development contract services
on
the Company’s balance sheet. Such advances on research and development contract
services are expensed over their life on the straight-line basis, unless the
achievement of milestones, the completion of contracted work, or other
information indicates that a different expensing schedule is more appropriate.
The Company accounts for its research and development contracts in accordance
with EITF 07-3.
Patent
Costs
Due
to the significant uncertainty associated with the successful development
of one or more commercially viable products based on the Company's research
efforts and any related patent applications, all patent costs are expensed
as
incurred
Stock-Based
Compensation
In
December 2004, the FASB issued Statement of Financial Accounting Standards
No.
123R, “Share-Based Payment” (“SFAS 123R”). SFAS 123R requires all share-based
payments, including grants of employee stock options to employees, to be
recognized in the financial statements based on their grant date fair values.
Effective January 1, 2006, SFAS 123R requires that the Company measure the
cost
of employee services received in exchange for equity awards based on the grant
date fair value of the awards, with the cost to be recognized as compensation
expense in the Company’s financial statements over the vesting period of the
awards.
The
Company accounts for income taxes under Statement of Financial Accounting
Standards No. 109, “Accounting for Income Taxes”, which requires the
recognition of deferred tax assets and liabilities for the expected impact
of
differences between the financial statements and the tax basis of assets and
liabilities.
22
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 focus is on developing new treatments for the most common and most
aggressive type of primary brain cancer, glioblastoma multiforme (“GBM”). The
Company entered into a Cooperative Research and Development Agreement (the
“CRADA”) with the National Institute of Neurological Diseases and Stroke
(“NINDS”) of the National Institutes of Health (“NIH”) to identify and evaluate
drugs that target a specific biochemical pathway for GBM cell differentiation.
The CRADA also covers research to determine whether expression of a component
of
this pathway correlates with prognosis in glioma patients.
The
lead
scientist at NINDS collaborating with the Company under the CRADA is Dr.
Zhengping Zhuang. Dr. Zhuang is internationally recognized for his research
in
molecular pathology. Dr. Zhuang has four issued and two pending patents related
to molecular pathology of human cancers. Dr. Zhuang recently discovered a
biomarker of relevance to the growth of GBMs that the Company believes can
be
used as a tool for identifying drugs that affect the growth of GBM cells. Under
the CRADA, the Company will support two persons at the NIH to work under the
direction of Dr. Zhuang. The goal is to identify drugs that inhibit GBM cell
growth and to determine if the identified biomarker may be useful for estimation
of prognosis. The Company’s contribution to the collaborative research done by
the Company and the NIH is $200,000 annually for two years to fund two research
assistants expected to be at the post-doctoral level, as well as supplies and
travel expenses.
On
February 6, 2006, the Company filed a provisional patent application naming
as co-inventors Dr. Zhuang and several other NIH investigators, and
Dr. Kovach covering certain methods and classes of molecules that are
expected to be the foundation of product development and commercialization
efforts with respect to human brain tumors. On February 6, 2007, the
Company filed on behalf of NIH co-inventors and Dr. Kovach a PCT
international patent including all countries participating in the Patent
Cooperation Treaty (except the USA) and an identical non-provisional patent
in
the USA. These two patent applications contain all claims in the provisional
patent of February 6, 2006 plus additional claims.
In
February 2007, the Company also filed a new U.S. provisional patent application
that does not fall under the CRADA. This application identifies a method of
synthesis and documents activity against glioblastoma multiforme cell lines
in
vitro of a proprietary lead compound, LB-1, and a series of homologs of this
compound. Additional patent applications were filed with new claims for homologs
of LB-1 (July, 2007); for extension of the use of the treatments claimed for
GBM
to the treatments of two types of pediatric cancers, meduloblastoma and
neuroblastoma (August, 2007); and for a new lead compound, LB-2.5, as
representative of several novel agents distinct in pharmacological activity
from
LB-1 also possessing anti-GBM activity (October 1, 2007).
23
Accordingly,
in the past nine months, the Company has filed five patent applications focused
on the identification of two classes of drugs, members of which inhibit the
growth of brain tumor cells and other types of cancers in model systems. The
patents claim the identity, methods of synthesis, and use for anti-cancer
treatment of lead compounds from each of the two classes. The compounds are
proprietary to the Company and the use claims are filed jointly with NIH under
the CRADA.
The
Company expected and continues to expect that its products will derive directly
from the intellectual property arising from its research activities. The
development of lead compounds with different mechanisms of action that are
both
active against GBM cells was based upon insight as to potential tumor cell
vulnerability derived from identification of the biomarker for GBM by the
Company’s collaborators at NINDS, NIH and claimed in a joint patent application
with NIH. The approach used to develop potentially effective drugs for GBM
will
continue to be the primary strategy of the Company to develop new therapies
and
potentially new diagnostic tests (based on biomarkers) for cancers other than
GBM in the future, subject to the availability of the appropriate resources
to
support such activities.
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 - September
30, 2007 - Going Concern” below).
Primary
Goal for the Next 12 Months
Because
of progress in identifying compounds that have anti-cancer activity against
human brain tumor cells in the test tube and in animal models, the Company’s
primary focus in the near-term will be to characterize of its two lead
compounds, LB-1 and LB-2.5, to meet the requirements of the FDA for submitting
an IND for a phase I clinical trial of one or both compounds. At the same time,
the Company will evaluate the activity of its lead compounds against other
common human cancers, first in the test tube, and then in animal models for
compounds showing activity.
The
Company will continue to develop preclinical data supporting the potential
effectiveness of these 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. An abstract of the activity of
LB-1 against human GBM cells in the test tube and growing in the mouse is being
submitted to be considered for presentation at a national cancer meeting in
spring 2008.
Over
the
next six months, the Company will assess the potential interest of two or three
of the major pharmaceutical companies in participating in the development of
its
lead compounds in the future. A decision will be made as to which regimens
are
most promising for development for human studies. This decision will be made
jointly by the Company with the advice of its scientific advisory board and
its
CRADA partner, NINDS. At this point, NINDS and the Company will consider whether
development of specific regimens for evaluation in humans should proceed via
an
extension of the existing CRADA, under a new CRADA with NINDS, or possibly
with
another institute at the NIH, by the Company alone via outsourcing all
pre-clinical drug evaluations required by the FDA to a commercial CRO, and/or
with a partner in the pharmaceutical industry capable of taking the drug(s)
though the IND process and conducting clinical evaluations. The existing CRADA
was extended to June 30, 2008 from March 2008 at no additional cost as the
funds
provided by the Company will support the collaboration at least until that
date.
24
Additional
Activities for the Next 12 Months
The
Company will also evaluate the anti-cancer activity of its two lead compounds
alone and in combination for activity against human GBMs in an animal (mouse)
model. The lead drugs appear to be synergistic in their ability to inhibit
the
growth of GBMs, e.g., a combination of two drugs inhibits GBMs to a greater
extent than would be expected from the sum of their inhibitory effects when
used
alone. These evaluations are being done at the NIH under protocols
developed by NINDS and the Company. The CRADA specifies evaluation of drug
regimens in animal models as one of the activities to be pursued by the Company
and NINDS.
In
addition, the Company will evaluate the effectiveness of LB-1 and LB-2.5 against
tumors other that GBM in the test tube. Since both compounds affect processes
that are disordered in cancer cells other than brain tumors, both drugs will
be
assessed for activity against a wide variety of common human cancers, including
cancers of the lung, colon, breast, stomach and ovary. This screening will
be
done under contract with a CRO, and results are expected by mid-2008. If
activity is found, the active drug(s) will be evaluated in mouse models of
the
appropriate cancer type analogous to the process being pursued for development
of new treatments for GBM.
The
Company will also continue to collect samples of human tumors and associated
blood and urine samples through the University of Regensburg under the Company’s
January 5, 2007 agreement with the Free State of Bavaria, Germany. The samples
will be used in the future to apply technology to search for new biomarkers
for
cancers other than GBM. The present CRADA with NINDS is limited to the study
of
GBM.
Plans
Beyond the Next 12 Months
The
Company expects to participate in clinical trials of new therapies in
partnership with an organization experienced in such undertakings. The
partnering organization may be either a clinical branch of NIH or a
pharmaceutical company with expertise in the conduct of clinical trials. The
Company’s present position is to take one or more of its new therapies for the
treatment of glioblastoma multiforme through pre-clinical evaluation as part
of
the CRADA with the NINDS of the NIH. After completing pre-clinical evaluation,
the Company will consider partnering with the NIH to conduct a phase I
trial or jointly with the NIH seek a third party, most probably a large
pharmaceutical company to carry the new therapies into Phase I trials.
After completion of Phase I trials, the Company, potentially in partnership
with the NIH or on its own, would collaborate with the third party to carry
new
therapies found to be safe for administration to humans in the Phase I
trials into Phase II trials.
Phase II
trials test the safety and effectiveness, as well as the best estimate of the
proper dose of the new therapies in a group of patients with the same type
of
cancer at the same stage. For the Company’s initial studies, the focus will be
brain tumors. The duration of Phase II trials may run from 6 to 24 months.
New regimens showing beneficial activity in Phase II trials may then be
considered for evaluation in Phase III trials. Phase III trials for
the evaluation of new cancer treatments are comparative trials in which the
therapeutic benefit of a new regimen is compared to the therapeutic benefit
of
the best standard regimen in a randomized study.
Whether
the Company will participate or be in a position to participate in any clinical
trials will depend upon partnerships and specific licensing agreements. However,
in all cases of clinical trial participation, 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.
25
Given
the
progress in identifying two lead compounds with activity in animal models of
GBM, the Company is devoting its resources to bring the agents to a point at
which an IND can be submitted to the FDA for a Phase I clinical trial. One
lead
compound (LB-1) is the most advanced in the process and the Company plans to
be
ready for IND submission by early 2009. The other lead compound (LB-2.5), which
inhibits cancer cells by a mechanism distinct from that of LB-1, is anticipated
to complete its evaluation by the end of 2009.
The
Company had planned to begin its own analyses of tumor types other than GBM
for
new biomarkers by late 2008. However, in order to do this, the Company would
need to establish and operate an independent laboratory. The creation and
operation of such a laboratory for two years is estimated to cost approximately
$2,000,000. Accordingly, the Company is deferring plans to open and staff an
independent laboratory until the full intellectual property value of its initial
lead compounds for treatment of brain tumors is determined.
The
Company is a development stage company and has not yet commenced
revenue-generating operations.
Three
Months Ended September 30, 2007 and 2006
General
and Administrative Expenses.
For the
three months ended September 30, 2007, general and administrative expenses
were
$853,075, which included $773,356 for the vested portion of the fair value
of
stock options issued and the fair value of common stock sold to a consultant,
as
compared to $65,251 for the three months ended September 30, 2006, which
included $8,917 for the vested portion of the fair value of stock options
issued. Included in general and administrative expenses for the three months
ended September 30, 2007 and 2006 was $19,500 and $5,000 of patent costs,
respectively.
The
significant components of general and administrative expenses to date consist
primarily of legal fees (including patent costs) 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 September 30, 2007 and 2006, depreciation expense was $148
and $115, respectively.
Research
and Development Costs.
For the
three months ended September 30, 2007, research and development costs were
$68,593, which included $4,918 for the vested portion of the fair value of
stock
options issued, as
compared to $50,100 for the three months ended September 30, 2006.
Interest
Income.
For the
three months ended September 30, 2007, interest income was $862, as compared
to
$6,588 for the three months ended September 30, 2006.
Net
Loss.
For the
three months ended September 30, 2007, the Company incurred a net loss of
$920,954, as compared to a net loss of $108,878 for the three months ended
September 30, 2006.
Nine
Months Ended September 30, 2007 and 2006
General
and Administrative Expenses.
For the
nine months ended September 30, 2007, general and administrative expenses were
$1,109,061, which included $791,064 for the vested portion of the fair value
of
stock options issued and the fair value of common stock sold to a consultant,
as
compared to $201,104 for the nine months ended September 30, 2006, which
included $88,483 for the vested portion of the fair value of stock options
issued. Included in general and administrative expenses for the nine months
ended September 30, 2007 and 2006 was $66,092 and $33,064 of patent costs,
respectively.
26
The
significant components of general and administrative expenses to date consist
primarily of legal fees (including patent costs) 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
nine months ended September 30, 2007 and 2006, depreciation expense was $444
and
$344, respectively.
Research
and Development Costs.
For the
nine months ended September 30, 2007, research and development costs were
$249,443, including $35,918 for the vested portion of the fair value of stock
options issued to a consultant and the fair value of a five-year stock option
to
purchase 100,000 shares of the Company’s common stock at $0.333 per share issued
to Chem-Master International, Inc. on February 5, 2007 that was fully vested
and
non-forfeitable on the date of issuance. Research and development costs were
$100,100 for the nine months ended September 30, 2006.
Reverse
Merger Costs.
In
conjunction with the reverse merger transaction completed on June 30, 2006,
WestPark Capital, Inc. was paid an aggregate cash fee of $50,000, which was
charged to operations during the nine months ended September 30,
2006.
Interest
Income.
For the
nine months ended September 30, 2007, interest income was $9,169, as compared
to
$6,588 for the nine months ended September 30, 2006.
Net
Loss.
For the
nine months ended September 30, 2007, the Company incurred a net loss of
$1,349,779, as compared to a net loss of $344,960 for the nine months ended
September 30, 2006.
Liquidity
and Capital Resources - September 30, 2007
Going
Concern
At
September 30, 2007, the Company had not yet commenced any revenue-generating
operations and was therefore considered a “development stage company”. All
activity through September 30, 2007 related to the Company’s formation, capital
raising efforts and initial research and development activities. As such, the
Company has yet to generate any cash flows from operations, and is essentially
dependent on debt and equity funding from both related and unrelated parties
to
finance its operations. Prior to June 30 2006, the Company’s cash requirements
were funded by advances from its founder, Dr. John Kovach, the Company’s Chief
Executive Officer. On June 30, 2006, the Company completed an initial closing
of
its private placement, selling 1,973,869 shares of common stock at a price
of
$0.333 per share and receiving net proceeds of $522,939. On July 27, 2006,
the
Company completed a second closing of its private placement, selling 1,581,351
shares of common stock at a price of $0.333 per share and receiving net proceeds
of $446,433.
Because
the Company is currently engaged in research at a very early stage, it will
likely take a significant amount of time to develop any product or intellectual
property capable of generating revenues. As such, the Company’s business is
unlikely to generate any revenue in the next several years and may never do
so.
Even if the Company is able to generate revenues in the future through licensing
its technologies or through product sales, there can be no assurance that such
revenues will exceed its expenses.
The
Company does not currently have sufficient resources to fully fund its planned
operations for the next nine months. The strain on the Company’s limited cash
resources has been further exacerbated by the registration penalty obligation
of
$74,000 (originally recorded at December 31, 2006 pursuant to EITF 00-19-2),
reflecting the cash amount currently payable to the investors in the private
placement for the registration penalty accrued through mid-May 2007. If the
Company does not maintain the effectiveness of its registration statement,
the
Company would be subject to a further registration penalty at the rate of
approximately $12,000 per 30-day period thereafter, continuing through July
2008. Since the Company only has cash of $124,069 and working capital of $28,877
(including the effect from the $74,000 registration penalty obligation referred
to above) at September 30, 2007, this short-term cash obligation and the
uncertainty related to it could have a material adverse impact on the Company’s
ability to fund its business plan and conduct operations.
27
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 September 30, 2007 and December
31, 2006 (Restated), stockholder advances totaled $92,717. The Company currently
does not anticipate repaying such advances until sufficient funds are available
to fund the Company’s business plan.
The
Company does not have sufficient resources to fully develop and commercialize
any products that may arise from its research. Accordingly, the Company will
need to raise additional funds in order to satisfy its future working capital
requirements. Based on the Company’s updated and revised operating budget, the
Company estimates that it will require approximately $600,000 of additional
funding through December 31, 2008. Thereafter, the Company currently estimates
that it will require an additional $2,000,000 to fund future operations,
including the possible establishment of a laboratory, depending on the
availability of capital and various operating developments. The amount and
timing of future cash requirements will depend on market acceptance of the
Company’s products, if any, and the resources that the Company devotes to
developing and supporting its products. The Company anticipates funding these
cash requirements from debt or equity financings, mergers or acquisitions,
and/or via the sale or license of its intellectual properties.
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 resources 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
nine months ended September 30, 2007, operating activities utilized cash of
$555,299, as compared to utilizing cash of $381,106 for the nine months ended
September 30, 2006.
The
Company had working capital of $28,877 at September 30, 2007, primarily as
a
result of the sale of the Company’s common stock pursuant to private placement
in June and July 2006 that generated net proceeds of $969,372.
Investing
Activities.
For the
nine months ended September 30, 2007 and 2006, investing activities utilized
net
cash of $272 and $238, respectively, for the purchase of office
equipment.
Financing
Activities.
There
were no financing activities for the nine months ended September 30, 2007.
For
the nine months ended September 30, 2006, financing activities provided net
cash
of $1,100,135, consisting of the gross proceeds from the sale of common stock
of
$1,183,889, the cash acquired in the reverse merger transaction of $62,500,
and
advances from stockholder of $86,771, reduced by the payment of private
placement offering costs of $233,025.
Principal
Commitments
At
September 30, 2007, the Company did not have any material commitments for
capital expenditures. The Company had paid its second and final installment
due
under the CRADA of $200,000 on June 29, 2007. The Company’s principal
commitments at September 30, 2007 consisted of the estimated liquidated damages
payable under the registration rights agreement of $74,000 and the contractual
obligations as summarized below.
28
On
January 5, 2007, Lixte entered into a Services Agreement with The Free State
of
Bavaria (Germany) represented by the University of Regensburg (the “University”)
pursuant to which Lixte retained the University to provide to it certain samples
of primary cancer tissue and related biological fluids to be obtained from
patients afflicted with specified types of cancer. The University will also
provide certain information relating to such patients. Lixte agreed to pay
the
University 72,000 Euros in two equal installments. The first installment of
36,000 Euros ($48,902) was paid on March 7, 2007, and the second installment
of
36,000 Euros (approximately $51,380 at September 30, 2007) 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. Lixte has the right to terminate the Agreement at
any
time during the term of the Agreement upon sixty days prior written
notice. On February 5, 2009, provided that the Agreement has not
been terminated prior to such date, Lixte agreed to grant Chem-Master
a second five-year option to purchase an additional 100,000 shares of the
Company’s common stock at an exercise price of $0.333 per
share.
On
September 20, 2007, the Company entered into a one-year consulting agreement
(the “Agreement”) with Mirador Consulting, Inc. (“Mirador”), pursuant to which
Mirador is to provide the Company with various financial services. Pursuant
to
the Agreement, Lixte agreed to pay Mirador $5,000 per month and also agreed
to
sell Mirador 250,000 shares of the Company’s restricted common stock for $250
($0.001 per share).
Off-Balance
Sheet Arrangements
At
September 30, 2007, the Company did not have any transactions, obligations
or
relationships that could be considered off-balance sheet
arrangements.
29
(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
September 30, 2007, the Company’s Chief Executive Officer and Chief Financial
Officer (who is the same individual) evaluated the effectiveness of the design
and operation of the Company’s disclosure controls and procedures. Based upon
and as of the date of that evaluation, the Chief Executive Officer and Chief
Financial Officer concluded that the Company’s disclosure controls and
procedures are effective to ensure that the information required to be disclosed
in the reports the Company files and submits under the Exchange Act is recorded,
processed, summarized, and reported as and when required.
(b)
|
Changes
in Internal Controls Over Financial
Reporting
|
There
were no changes in the Company’s internal control over financial reporting or in
other factors that materially affect, or are reasonably likely to materially
affect, those controls subsequent to the date of the Company’s most recent
evaluation.
30
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
June
20, 2007, the Board of Directors of the Company approved the 2007 Stock
Compensation Plan (the “2007 Plan”), which provides for the granting of awards,
consisting of common stock options, stock appreciation rights, performance
shares, or restricted shares of common stock, to employees and independent
contractors, for up to 2,500,000 shares of the Company’s common stock, under
terms and condition, as determined by the Company’s Board of Directors. On
September 12, 2007, pursuant to the 2007 Plan, the Company granted to Dr.
Stephen Carter, stock options to purchase an aggregate of 200,000 shares of
common stock, exercisable for a period of five years from vesting date at $0.333
per share, with one-half (100,000 shares) vesting annually on each of September
12, 2008 and 2009. The fair value of these options, as calculated pursuant
to
the Black-Scholes option-pricing model, was determined to be $204,000 ($1.02
per
share), which is being charged to operations ratably from September 12, 2007
through September 12, 2009. During the three months ended September 30, 2007,
the Company recorded a charge to operations of $5,016 with respect to these
options.
On
September 12, 2007, the Company entered into a consulting agreement with Gil
Schwartzberg and granted to Mr. Schwartzberg stock options to purchase an
aggregate of 1,000,000 shares of common stock, exercisable for a period of
four
years from vesting date at $1.00 per share, with one-half of the options
(500,000 shares) vesting immediately and one-half (500,000 share) vesting on
September 12, 2008. The fair value of these options, as calculated pursuant
to
the Black-Scholes option-pricing model, was determined to be $945,000 ($0.945
per share), of which $465,000 was charged to operations on September 12, 2007,
and the remaining $480,000 is being charged to operations ratably from September
12, 2007 through September 12, 2008. During the three months ended September
30,
2007, the Company recorded a charge to operations of $488,607 with respect
to
these options.
On
September 12, 2007, the Company entered into a consulting agreement with Francis
Johnson and granted to Professor Johnson stock options to purchase an aggregate
of 300,000 shares of common stock, exercisable for a period of four years from
vesting date at $0.333 per share, with one-third (100,000 shares) vesting
annually on each of September 12, 2008, 2009 and 2010. The fair value of these
options, as calculated pursuant to the Black-Scholes option-pricing model,
was
determined to be $300,000 ($1.00 per share), which is being charged to
operations ratably from September 12, 2007 through September 12, 2010. During
the three months ended September 30, 2007, the Company recorded a charge to
operations of $4,918, with respect to these options.
On
September 20, 2007, the Company entered into a one-year consulting agreement
(the “Agreement”) with Mirador Consulting, Inc. (“Mirador”), pursuant to which
Mirador is to provide the Company with various financial services. Pursuant
to
the Agreement, Lixte agreed to pay Mirador $5,000 per month and also agreed
to
sell Mirador 250,000 shares of the Company’s restricted common stock for $250
($0.001 per share). The fair value of this transaction was determined to be
in
excess of the purchase price by $262,250 ($1.049 per share), reflecting the
difference between the $0.001 purchase price and the $1.05 price per share
as
quoted on the OTC Bulletin Board, and was charged to operations as stock-based
compensation during the three months ended September 30, 2007.
Not
applicable.
31
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.
32
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:
November 13, 2007
|
By: | /s/ JOHN S. KOVACH | |
John
S. Kovach
|
|||
Chief Executive Officer and Chief Financial Officer | |||
(Principal
financial and accounting officer)
|
33
INDEX
TO
EXHIBITS
Exhibit
Number
|
Description
of Document
|
|
|
|
|
10.1
|
Services
Agreement between Lixte Biotechnology, Inc. and Freestate of Bavaria
represented by University
of Regensburg dated January 5, 2007, previously filed as an exhibit
to the
Company’s
Current Report on Form 8-K filed on January 11, 2007, and incorporated
herein by reference.
|
|
|
|
|
10.2
|
Agreement
between Lixte Biotechnology Holdings, Inc. and Chem-Master International,
Inc. dated
February 5, 2007, previously filed as an exhibit to the Company’s Current
Report on Form 8-K
filed on February 9, 2007, and incorporated herein by
reference.
|
|
|
|
|
10.3
|
2007
Stock Compensation Plan adopted by the Company’s Board of Directors on
June 20, 2007, previously filed as an exhibit to the Company’s Quarterly
Report on Form 10-QSB for the Quarterly Period Ended June 30, 2007,
and
incorporated herein by reference.
|
|
10.4
|
Stock
Option Agreement between Lixte Biotechnology Holdings, Inc. and Stephen
K.
Carter dated September 12, 2007. (1)
|
|
10.5
|
Stock
Option Agreement between Lixte Biotechnology Holdings, Inc. and Francis
Johnson dated September 12, 2007. (1)
|
|
10.6
|
Stock
Option Agreement between Lixte Biotechnology Holdings, Inc. and Gil
Schwartzberg dated
September 12, 2007. (1)
|
|
10.7
|
Consulting
Agreement between Lixte Biotechnology Holdings, Inc. and Gil Schwartzberg
dated September 12, 2007. (1)
|
|
10.8
|
Consulting
Agreement between Lixte Biotechnology Holdings, Inc. and Mirador
Consulting, Inc. dated September 20, 2007. (1)
|
|
10.9
|
Consulting Agreement between Lixte Biotechnology Holdings, Inc. and Francis Johnson dated September 12, 2007. (1) | |
31
|
Certifications
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
(1)
|
|
|
|
|
32
|
Certifications
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
(1)
|
(1) |
Filed
herewith.
|
34