LIXTE BIOTECHNOLOGY HOLDINGS, INC. - Quarter Report: 2008 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the
quarterly period ended June 30, 2008
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE EXCHANGE ACT OF
1934
|
Commission
file number: 000-51476
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
(Exact
name of registrant 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
(Registrant’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 registrant (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 large accelerated filer, an
accelerated filer, or a non-accelerated filer (as defined in Rule 12b-2 of
the
Exchange Act).
Accelerated
filer o
|
|
Non-accelerated
filer o
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o
No
x
As
of
July 31, 2008, the Company had 27,932,178 shares of common stock, $0.0001 par
value, issued and outstanding.
Documents
incorporated by reference: None
1
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
INDEX
|
Page
Number
|
PART
I - FINANCIAL INFORMATION
|
|
|
|
Item
1. Financial Statements
|
|
|
|
Condensed
Consolidated Balance Sheets -
|
|
June
30, 2008 (Unaudited) and December 31, 2007
|
4
|
|
|
Condensed
Consolidated Statements of Operations (Unaudited) -
|
|
Three
Months and Six Months Ended June 30, 2008 and 2007, and August 9,
2005 (Inception) to June 30, 2008 (Cumulative)
|
5
|
|
|
Condensed
Consolidated Statement of Changes in Stockholders’ Equity (Deficiency)
(Unaudited) -
|
|
August 9,
2005 (Inception) to June 30, 2008
|
6
|
|
|
Condensed
Consolidated Statements of Cash Flows (Unaudited) -
|
|
Six
Months Ended June 30, 2008 and 2007, and August 9, 2005 (Inception)
to June 30, 2008 (Cumulative)
|
7
|
|
|
Notes
to Condensed Consolidated Financial Statements -
|
|
Three
Months and Six Months Ended June 30, 2008 and 2007
(Unaudited)
|
9
|
|
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
22
|
|
|
Item
3. Quantitative and Qualitative Disclosures About Market
Risk
|
33
|
|
|
Item
4T. Controls and Procedures
|
33
|
|
|
PART
II - OTHER INFORMATION
|
|
|
|
Item
1. Legal Proceedings
|
34
|
Item
1A. Risk Factors
|
34
|
|
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
34
|
|
|
Item
3. Defaults Upon Senior Securities
|
34
|
|
|
Item
4. Submission of Matters to a Vote of Security
Holders
|
34
|
|
|
Item
5. Other Information
|
34
|
|
|
Item
6. Exhibits
|
34
|
|
|
SIGNATURES
|
35
|
2
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q 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 1of this Quarterly Report on
Form 10-Q.
3
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
June 30,
2008
|
December 31,
2007
|
|||||
|
(Unaudited)
|
|
|||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
and cash equivalents
|
$
|
201,935
|
$
|
508,070
|
|||
Advances
on research and development contract services
|
18,750
|
88,180
|
|||||
Prepaid
expenses
|
5,308
|
32,117
|
|||||
Total
current assets
|
225,993
|
628,367
|
|||||
Office
equipment,
net of accumulated depreciation of $1,485 at June 30, 2008
and
$1,167 at December 31, 2007
|
424
|
742
|
|||||
Total
assets
|
$
|
226,417
|
$
|
629,109
|
|||
|
|||||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable and accrued expenses
|
$
|
48,194
|
$
|
73,741
|
|||
Liquidated
damages payable under registration rights agreement
|
74,000
|
74,000
|
|||||
Research
and development contract liabilities
|
—
|
11,725
|
|||||
Due
to stockholder
|
92,717
|
92,717
|
|||||
Total
current liabilities
|
214,911
|
252,183
|
|||||
|
|||||||
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 - 27,932,178 shares at June 30, 2008 and
27,832,178
shares at December 31, 2007
|
2,793
|
2,783
|
|||||
Additional
paid-in capital
|
2,748,992
|
2,600,839
|
|||||
Deficit
accumulated during the development stage
|
(2,740,279
|
)
|
(2,226,696
|
)
|
|||
Total
stockholders’ equity
|
11,506
|
376,926
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
226,417
|
$
|
629,109
|
See
accompanying notes to condensed consolidated financial statements.
4
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
|
|
Period from
August 9,
2005
(Inception) to
|
||||||||||||||
|
Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
June 30,
2008
|
|||||||||||||
2008
|
2007
|
2008
|
2007
|
(Cumulative)
|
||||||||||||
Revenues
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||
|
||||||||||||||||
Costs
and expenses:
|
||||||||||||||||
General
and administrative, including $(100,355) and $8,792 of stock-based
expense
during the three months ended June 30, 2008 and 2007, respectively,
$64,794 and $17,708 of stock-based expense during the six months
ended June 30, 2008 and 2007, respectively, and $1,052,638 for the
period
from August 9, 2005 (inception) to June 30, 2008
(cumulative)
|
(50,947
|
)
|
89,241
|
217,869
|
199,244
|
1,669,791
|
||||||||||
Depreciation
|
159
|
148
|
318
|
296
|
1,485
|
|||||||||||
Research
and development costs, including $(25,564) and $0 of stock-based
expense
during the three months ended June 30, 2008 and 2007, respectively,
$83,369 and $31,000 of stock-based expense during the six months
ended June 30, 2008 and 2007, respectively, and $134,205 for the
period
from August 9, 2005 (inception) to June 30, 2008
(cumulative)
|
61,782
|
89,917
|
298,233
|
237,592
|
970,288
|
|||||||||||
Reverse
merger costs
|
—
|
—
|
—
|
—
|
50,000
|
|||||||||||
Total
costs and expenses
|
10,994
|
179,306
|
516,420
|
437,132
|
2,691,564
|
|||||||||||
|
(10,994
|
)
|
(179,306
|
)
|
(516,420
|
)
|
(437,132
|
)
|
(2,691,564
|
)
|
||||||
Interest
income
|
733
|
3,584
|
2,838
|
8,307
|
25,285
|
|||||||||||
Liquidated
damages under registration rights agreement
|
—
|
—
|
—
|
—
|
(74,000
|
)
|
||||||||||
Net
loss
|
$
|
(10,261
|
)
|
$
|
(175,722
|
)
|
$
|
(513,582
|
)
|
$
|
(428,825
|
)
|
$
|
(2,740,279
|
)
|
|
Net
loss per common share - basic and diluted
|
$
|
(0.00
|
)
|
$
|
(0.01
|
)
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
||||
Weighted
average common shares outstanding - basic and diluted
|
27,932,178
|
26,582,183
|
27,916,793
|
26,582,183
|
See
accompanying notes to condensed consolidated financial statements.
5
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENT OF CHANGES
IN
STOCKHOLDERS’ EQUITY (DEFICIENCY)
Period
from August 9, 2005 (Inception) to June 30, 2008
Common
Stock
|
Additional
Paid-in
|
Deficit
Accumulated
During
the
Development
|
Total
Stockholders’
Equity
|
|||||||||||||
Shares
|
Amount
|
Capital
|
Stage
|
(Deficiency)
|
||||||||||||
Balance,
August 9, 2005 (inception)
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
$
|
—
|
|||||||
Shares
issued to founding stockholder
|
19,021,786
|
1,902
|
(402
|
)
|
—
|
1,500
|
||||||||||
Net
loss 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
|
26,582,183
|
2,658
|
1,128,114
|
(578,208
|
)
|
552,564
|
||||||||||
Shares
issued in private placement, net of offering costs of
$118,680
|
999,995
|
100
|
531,220
|
—
|
531,320
|
|||||||||||
Stock-based
compensation
|
250,000
|
25
|
890,669
|
—
|
890,694
|
|||||||||||
Stock-based
research and development costs
|
—
|
—
|
50,836
|
—
|
50,836
|
|||||||||||
Net
loss for the year
|
(1,648,488
|
)
|
(1,648,488
|
)
|
||||||||||||
Balance,
December 31, 2007
|
27,832,178
|
2,783
|
2,600,839
|
(2,226,696
|
)
|
376,926
|
||||||||||
Stock-based
compensation
|
—
|
—
|
64,794
|
—
|
64,794
|
|||||||||||
Stock-based
research and development costs
|
100,000
|
10
|
83,359
|
—
|
83,369
|
|||||||||||
Net
loss for the six months ended June 30, 2008
|
—
|
—
|
—
|
(513,583
|
)
|
(513,583
|
)
|
|||||||||
Balance,
June 30, 2008 (unaudited)
|
27,932,178
|
$
|
2,793
|
$
|
2,748,992
|
$
|
(2,740,279
|
)
|
$
|
11,506
|
See
accompanying notes to condensed consolidated financial statements.
6
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
Six Months Ended
June
30,
|
Period from
August 9,
2005
(Inception) to
June
30, 2008
|
|||||||||
2008
|
2007
|
(Cumulative)
|
||||||||
Cash
flows from operating activities
|
||||||||||
Net
loss
|
$
|
(513,583
|
)
|
$
|
(428,825
|
)
|
$
|
(2,740,279
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||
Depreciation
|
318
|
296
|
1,485
|
|||||||
Stock-based
compensation
|
64,794
|
17,708
|
1,052,638
|
|||||||
Stock-based
research and development costs
|
83,369
|
31,000
|
134,205
|
|||||||
Changes
in operating assets and liabilities:
|
||||||||||
(Increase)
decrease in -
|
||||||||||
Advances
on research and development contract services
|
69,430
|
(124,925
|
)
|
(18,750
|
)
|
|||||
Prepaid
expenses
|
26,809
|
14,375
|
(5,308
|
)
|
||||||
Increase
(decrease) in -
|
||||||||||
Accounts
payable and accrued expenses
|
(25,547
|
)
|
(20,199
|
)
|
48,194
|
|||||
Research
and development contract liabilities
|
(11,725
|
)
|
25,873
|
—
|
||||||
Liquidated
damages payable under registration rights agreement
|
—
|
—
|
74,000
|
|||||||
Net
cash used in operating activities
|
(306,135
|
)
|
(484,697
|
)
|
(1,453,815
|
)
|
||||
|
||||||||||
Cash
flows from investing activities
|
||||||||||
Purchase
of office equipment
|
—
|
(272
|
)
|
(1,909
|
)
|
|||||
Net
cash used in investing activities
|
—
|
(272
|
)
|
(1,909
|
)
|
|||||
|
||||||||||
Cash
flows from financing activities
|
||||||||||
Proceeds
from sale of common stock to consulting firm
|
—
|
—
|
250
|
|||||||
Proceeds
from sale of common stock to founder
|
—
|
—
|
1,500
|
|||||||
Cash
acquired in reverse merger transaction
|
—
|
—
|
62,500
|
|||||||
Gross
proceeds from sale of common stock
|
—
|
—
|
1,833,889
|
|||||||
Payment
of private placement offering costs
|
—
|
—
|
(333,197
|
)
|
||||||
Advances
from stockholder
|
—
|
—
|
92,717
|
|||||||
Net
cash provided by financing activities
|
—
|
—
|
1,657,659
|
|||||||
|
||||||||||
Net
increase (decrease) in cash
|
(306,135
|
)
|
(484,969
|
)
|
201,935
|
|||||
Cash
at beginning of period
|
508,070
|
679,640
|
—
|
|||||||
Cash
at end of period
|
$
|
201,935
|
$
|
194,671
|
$
|
201,935
|
(continued)
7
AND
SUBSIDIARY
(a
development stage company)
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
(continued)
Six Months Ended
June
30,
|
Period from
August 9,
2005
(Inception)
to
June 30, 2008
|
|||||||||
|
2008
|
2007
|
(Cumulative)
|
|||||||
|
|
|
|
|||||||
Supplemental
disclosures of cash flow information:
|
||||||||||
Cash
paid for -
|
||||||||||
Interest
|
$
|
—
|
$
|
—
|
$
|
—
|
||||
Income
taxes
|
$
|
—
|
$
|
—
|
$
|
—
|
See
accompanying notes to condensed consolidated financial statements.
8
LIXTE
BIOTECHNOLOGY HOLDINGS, INC.
AND
SUBSIDIARY
(a
development stage company)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Three
Months and Six Months Ended June 30, 2008 and 2007
(Unaudited)
1.
Organization and Business Operations
Organization
On
June
30, 2006, Lixte Biotechnology, Inc., a privately-held Delaware corporation
(“Lixte”), completed a reverse merger transaction with SRKP 7, Inc. (“SRKP”), a
non-trading 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.
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.
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
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 at June 30, 2008, for the three
months and six months ended June 30, 2008 and 2007, and for the period from
August 9, 2005 (inception) to June 30, 2008 (cumulative), are unaudited. In
the opinion of management, all adjustments (including normal recurring
adjustments) have been made that are necessary to present fairly the financial
position of the Company as of June 30, 2008, the results of its operations
for
the three months and six months ended June 30, 2008 and 2007, and for the period
from August 9, 2005 (inception) to June 30, 2008 (cumulative), and its cash
flows for the six months ended June 30, 2008 and 2007, and for the period from
August 9, 2005 (inception) to June 30, 2008 (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, 2007 has been derived from the Company’s audited financial
statements as of that date.
The
statements and related notes have been prepared pursuant to the rules and
regulations of the 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 for the
fiscal year ended December 31, 2007, as filed with the Securities and Exchange
Commission.
Operations
The
Company is concentrating on discovering biomarkers for common cancers and on
developing new treatments based on an understanding of the molecular activity
of
these biomarkers for common cancers. 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.
9
The
Company is currently focusing on developing new treatments for the most common
and most aggressive type of brain cancer of adults, glioblastoma multiforme
(“GBM”). The Company is conducting its anti-cancer activities primarily through
a collaborative program governed by a Cooperative Research and Development
Agreement (“CRADA”) with the National Institute of Neurological Disorders and
Stroke (“NINDS”) of the National Institutes of Health (“NIH”).
The
Company has expanded the scope of its anti-cancer investigational activities
to
include the most common brain tumor of children, medulloblastoma, and also
to
several other types of more common cancers. This expansion of activity is based
on documentation that each of two distinct types of drugs being developed by
the
Company inhibits the growth of cell lines of breast, colon, lung, prostate,
pancreas, ovary, stomach and liver cancer, as well as the major types of
leukemias. During the three months ended June 30, 2008, two different lead
compounds, previously shown to have activity again brain tumors, were found
to
also have activity in a mouse model of human pancreatic cancer.
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 will continue to use discovery and/or recognition of molecular variants
characteristic of specific human cancers as a guide to drug discovery and
potentially new diagnostic tests.
The
Company is considered a “development stage company” as defined in SFAS 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
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.
The
Company’s ability to continue as a going concern is dependent upon its ability
to develop additional sources of capital and to ultimately achieve profitable
operations. The accompanying financial statements do not include any adjustments
that might result from the outcome of these uncertainties.
The
Company is currently devoting its efforts to research and development related
to
discovering specific cancer biomarkers for early detection, estimation of
prognosis, monitoring response to treatment, development of targeted therapeutic
agents and new treatments based on an understanding of the molecular activity
of
these biomarkers for common cancers. The Company is seeking to exploit this
opportunity through execution of its business plan and the development of
related patents.
At
June
30, 2008, the Company had not yet commenced any revenue-generating operations.
All activity through June 30, 2008 is 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 a 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 the 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.
On
December 12, 2007, the Company completed a second private placement, selling
999,995 shares of common stock at a price of $0.65 per share and receiving
net
proceeds of $531,320.
10
Because
the Company is currently engaged in research at an 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’s current resources are marginally adequate to fund the Company’s basic
operating budget through December 31, 2008, but are not sufficient to fund
expanded research activities with respect to the Company’s promising
intellectual property during the remainder of 2008 and beyond. The Company
does
not have sufficient resources to fully develop and commercialize any products
that may arise from its research. Accordingly, the Company will need to raise
additional funds in order to satisfy its future working capital requirements.
Based
on
the Company’s revised and updated research program, the Company currently
estimates that it will require additional funds of approximately $2,000,000
for
the year ending December 31, 2009 in order to fund operations and continuing
drug discovery and to bring one drug through the pre-clinical evaluation process
needed for submission of an IND. The Company is attempting to arrange such
funding during the next few months, although there can be no assurances that
the
Company will be successful in this regard. The amount and timing of future
cash
requirements will depend on the market’s evaluation of the Company’s technology
and products, and the resources that the Company devotes to developing and
supporting its activities. The Company anticipates funding these cash
requirements from a combination of debt or equity financings and the sale,
licensing or joint venturing 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, as a result of which 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 technology and product development
programs, or obtain funds, if available, through strategic alliances that may
require the Company to relinquish rights to certain of its technologies
products, or to discontinue its operations entirely.
2.
Summary of Significant Accounting Policies
Principles
of Consolidation
The
accompanying 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.
Cash
and Cash Equivalents and Concentrations
The
Company considers all highly liquid investments with an original maturity of
three months or less when purchased to be cash equivalents. At times, such
cash
and cash equivalents may exceed federally insured limits. The Company has not
experienced a loss in such accounts to date. The Company maintains its accounts
with financial institutions with high credit ratings.
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, patent fees and costs, and other expenses relating to the
acquisition, design, development and testing of the Company's treatments
and product candidates.
11
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,
as amended, 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 funded ongoing
research and development activities through June 30, 2008. In June 2008, the
CRADA was extended to September 30, 2009 with no additional funding required
for
the period between July 1, 2008 and September 30, 2008. However, for the period
from October 1, 2008 through September 30, 2009, the Company has agreed to
provide additional funding under the CRADA of $200,000, to be paid in four
quarterly installments of $50,000 commencing on October 1, 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, including patent-related
legal fees, are expensed as incurred. Patent costs were $34,224 and $6,592
for
the three months ended June 30, 2008 and 2007, respectively, $74,224 and $46,592
for the six months ended June 30, 2008 and 2007, respectively, and $235,133
for
the period from August 9, 2005 (inception) to June 30, 2008 (cumulative). Patent
costs are included in research and development costs in the Company's statement
of operations.
Income
Taxes
The
Company accounts for income taxes pursuant to Statement of Financial Accounting
Standards No. 109, “Accounting for Income Taxes” (“SFAS No. 109”), which
establishes financial accounting and reporting standards for the effects of
income taxes that result from an enterprise’s activities during the current and
preceding years. SFAS No. 109 requires an asset and liability approach for
financial accounting and reporting for income taxes. Accordingly, the Company
recognizes deferred tax assets and liabilities for the expected impact of
differences between the financial statements and the tax basis of assets and
liabilities.
For
federal income tax purposes, substantially all expenses, except for interest,
taxes, and research and development, are deemed start-up and organization costs
and must be deferred until the Company commences business operations at which
time they may be written off over a 180-month period. The Company has elected
to
deduct research and development costs currently.
The
Company records a valuation allowance to reduce its deferred tax assets to
the
amount that is more likely than not to be realized. In the event the Company
was
to determine that it would be able to realize its deferred tax assets in the
future in excess of its recorded amount, an adjustment to the deferred tax
assets would be credited to operations in the period such determination was
made. Likewise, should the Company determine that it would not be able to
realize all or part of its deferred tax assets in the future, an adjustment
to
the deferred tax assets would be charged to operations in the period such
determination was made.
For
federal income tax purposes, net operating losses can be carried forward for
a
period of 20 years until they are either utilized or until they
expire.
In
July 2006, the Financial Accounting Standards Board (“FASB”) issued FASB
Interpretation No. 48, “Accounting for Uncertainty in Income Taxes, an
interpretation of FASB Statement No. 109” (“FIN 48”), which provides
criteria for the recognition, measurement, presentation and disclosure of
uncertain tax positions. A tax benefit from an uncertain position may be
recognized only if it is “more likely than not” that the position is sustainable
based on its technical merits. The Company adopted the provisions of FIN 48
on January 1, 2007.
12
Stock-Based
Compensation
Effective
January 1, 2006, the Company adopted SFAS No. 123 (revised 2004), "Share-Based
Payment" ("SFAS No. 123R"), a revision to SFAS No. 123, "Accounting for
Stock-Based Compensation". SFAS No. 123R 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. 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.
In
December 2007, the Securities and Exchange Commission issued Staff Accounting
Bulletin No. 110 (“SAB 110”), which expresses the views of the staff regarding
the use of a “simplified” method, as discussed in Staff Accounting Bulletin No.
107, in developing an estimate of expected term of “plain vanilla” share options
in accordance with SFAS No. 123R. The staff indicated that it will accept a
company’s election to use the simplified method, regardless of whether the
company has sufficient information to make more refined estimates of expected
term. SAB 110 was effective January 1, 2008, and did not have a significant
impact on the Company’s consolidated financial statements.
In
addition, commencing January 1, 2006, the Company was required to recognize
the
unvested portion of the grant date fair value of awards issued prior to the
adoption of SFAS No. 123R based on the fair values previously calculated for
disclosure purposes over the remaining vesting period of the outstanding stock
options and warrants. The Company did not have any unvested outstanding stock
options or warrants at December 31, 2005.
The
Company accounts for stock option and warrant grants issued and vesting to
non-employees in accordance with EITF No. 96-18, “Accounting for Equity
Instruments that are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services”, and EITF 00-18, “Accounting
Recognition for Certain Transactions involving Equity Instruments Granted to
Other Than Employees”, whereas the value of the stock compensation is based upon
the measurement date as determined at either (a) the date at which a performance
commitment is reached or (b) at the date at which the necessary performance
to
earn the equity instruments is complete.
Earnings
Per Share
The
Company computes earnings per share (“EPS”) in accordance with SFAS
No. 128, “Earnings per Share” and SEC Staff Accounting Bulletin
No. 98. SFAS No. 128 requires companies with complex capital
structures to present basic and diluted EPS. Basic EPS is measured as the
income (loss) available to common shareholders divided by the weighted average
common shares outstanding for the period. Diluted EPS is similar to basic
EPS but presents the dilutive effect on a per share basis of potential common
shares (e.g., warrants and options) as if they had been converted at the
beginning of the periods presented, or issuance date, if later. Potential
common shares that have an anti-dilutive effect (i.e., those that increase
income per share or decrease loss per share) are excluded from the calculation
of diluted EPS.
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.
13
At
June
30, 2008 and December 31, 2007, the Company had securities outstanding entitling
the holder thereof to acquire shares of common stock as
follows:
|
June
30,
2008
|
December 31,
2007
|
|||||
Warrants
|
546,626
|
546,626
|
|||||
Stock
options
|
2,290,000
|
2,090,000
|
|||||
Total
|
2,836,626
|
2,636,626
|
Equipment
Equipment
is recorded at cost. Depreciation expense is provided on a straight-line basis
using estimated useful lives of 3 years. Maintenance and repairs are charged
to
expense as incurred. When assets are retired or otherwise disposed of, the
property accounts are relieved of costs and accumulated depreciation and any
resulting gain or loss is credited or charged to operations.
Fair
Value of Financial Instruments
The
carrying amounts of cash and cash equivalents, prepaid expenses, accounts
payable, accrued expenses and due to stockholder approximate their respective
fair values due to the short-term nature of these items and/or the current
interest rates payable in relation to current market conditions.
Use
of Estimates
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.
Reclassification
Certain
reclassifications have been made to prior period balances to conform to the
June
30, 2008 presentation. Such reclassifications did not have any effect on results
of operations.
Adoption
of New Accounting Policies
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 (“GAAP”). 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 American Institute of Certified
Public Accountants (“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 was effective January 1, 2008,
and did
not have any impact on the Company’s financial statement presentation or
disclosures in 2008.
In
February 2007, the FASB issued Statement of Financial Accounting Standards
No. 159, “The Fair Value Option for Financial Assets and Financial
Liabilities” (“SFAS No. 159”), which provides companies with an option
to report selected financial assets and liabilities at fair value.
SFAS No. 159’s objective is to reduce both complexity in accounting
for financial instruments and the volatility in earnings caused by measuring
related assets and liabilities differently. Generally accepted accounting
principles have required different measurement attributes for different assets
and liabilities that can create artificial volatility in earnings.
SFAS No. 159 helps to mitigate this type of accounting-induced
volatility by enabling companies to report related assets and liabilities at
fair value, which would likely reduce the need for companies to comply with
detailed rules for hedge accounting. SFAS No. 159 also establishes
presentation and disclosure requirements designed to facilitate comparisons
between companies that choose different measurement attributes for similar
types
of assets and liabilities. SFAS No. 159 requires companies to provide
additional information that will help investors and other users of financial
statements to more easily understand the effect of the company’s choice to use
fair value on its earnings. SFAS No. 159 also requires companies to
display the fair value of those assets and liabilities for which the company
has
chosen to use fair value on the face of the balance sheet.
SFAS No. 159 does not eliminate disclosure requirements included in
other accounting standards, including requirements for disclosures about fair
value measurements included in SFAS No. 157 and
SFAS No. 107. SFAS No. 159 was effective January 1, 2008,
and
did not
have any impact on the Company’s financial statement presentation or disclosures
in 2008.
14
Recent
Accounting Pronouncements
In
December 2007, the FASB issued SFAS No. 141(R), “Business
Combinations” (“SFAS No. 141(R)”), which requires an acquirer to
recognize in its financial statements as of the acquisition date (i) the
identifiable assets acquired, the liabilities assumed, and any noncontrolling
interest in the acquiree, measured at their fair values on the acquisition
date,
and (ii) goodwill as the excess of the consideration transferred plus the
fair value of any noncontrolling interest in the acquiree at the acquisition
date over the fair values of the identifiable net assets acquired.
Acquisition-related costs, which are the costs an acquirer incurs to effect
a
business combination, will be accounted for as expenses in the periods in which
the costs are incurred and the services are received, except that costs to
issue
debt or equity securities will be recognized in accordance with other applicable
GAAP. SFAS No. 141(R) makes significant amendments to other Statements
and other authoritative guidance to provide additional guidance or to conform
the guidance in that literature to that provided in SFAS No. 141(R).
SFAS No. 141(R) also provides guidance as to what information is to be
disclosed to enable users of financial statements to evaluate the nature and
financial effects of a business combination. SFAS No. 141(R) is
effective for financial statements issued for fiscal years beginning on or
after
December 15, 2008. Early adoption is prohibited. The
adoption of SFAS No. 141(R) will affect how the Company accounts for a
business combination concluded after December 31, 2008.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests
in Consolidated Financial Statements — an amendment of ARB No. 51”
(“SFAS No. 160”), which revises the relevance, comparability, and
transparency of the financial information that a reporting entity provides
in
its consolidated financial statements by establishing accounting and reporting
standards that require (i) the ownership interests in subsidiaries held by
parties other than the parent be clearly identified, labeled, and presented
in
the consolidated statement of financial position within equity, but separate
from the parent’s equity, (ii) the amount of consolidated net income
attributable to the parent and to the noncontrolling interest be clearly
identified and presented on the face of the consolidated statement of income,
(iii) changes in a parent’s ownership interest while the parent retains its
controlling financial interest in its subsidiary be accounted for consistently
as equity transactions, (iv) when a subsidiary is deconsolidated, any
retained noncontrolling equity investment in the former subsidiary be initially
measured at fair value, with the gain or loss on the deconsolidation of the
subsidiary being measured using the fair value of any noncontrolling equity
investment rather than the carrying amount of that retained investment, and
(v) entities provide sufficient disclosures that clearly identify and
distinguish between the interests of the parent and the interests of the
noncontrolling owners. SFAS No. 160 amends FASB No. 128 to
provide that the calculation of earnings per share amounts in the consolidated
financial statements will continue to be based on the amounts attributable
to
the parent. SFAS No. 160 is effective for financial statements issued
for fiscal years, and interim periods within those fiscal years, beginning
on or
after December 15, 2008. Early adoption is prohibited.
SFAS No. 160 shall be applied prospectively as of the beginning of the
fiscal year in which it is initially applied, except for the presentation and
disclosure requirements, which shall be applied retrospectively for all periods
presented. The Company has not yet determined the effect on its consolidated
financial statements, if any, upon adoption of SFAS No. 160.
In
March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments
and Hedging Activities - an amendment of FASB Statement No. 133” (“SFAS No.
161”). SFAS No. 161 amends and expands the disclosure requirements of SFAS No.
133, “Accounting for Derivative Instruments and Hedging Activities” (“SFAS No.
133”). The objective of SFAS No. 161 is to provide users of financial statements
with an enhanced understanding of how and why an entity uses derivative
instruments, how derivative instruments and related hedged items are accounted
for under SFAS No. 133 and its related interpretations, and how derivative
instruments and related hedged items affect an entity’s financial position,
financial performance, and cash flows. SFAS No. 161 requires qualitative
disclosures about objectives and strategies for using derivatives, quantitative
disclosures about fair value amounts of and gains and losses on derivative
instruments, and disclosures about credit-risk-related contingent features
in
derivative agreements. SFAS No. 161 applies to all derivative financial
instruments, including bifurcated derivative instruments (and nonderivative
instruments that are designed and qualify as hedging instruments pursuant to
paragraphs 37 and 42 of SFAS No. 133) and related hedged items accounted for
under SFAS No. 133 and its related interpretations. SFAS No. 161 also amends
certain provisions of SFAS No. 131. SFAS No. 161 is effective for financial
statements issued for fiscal years and interim periods beginning after November
15, 2008, with early application encouraged. SFAS No. 161 encourages, but does
not require, comparative disclosures for earlier periods at initial adoption.
The Company has not yet determined the effect on its consolidated financial
statements, if any, upon adoption of SFAS No. 161.
15
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.
Private
Placements
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 accredited investors in
an
initial closing of a 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 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.
16
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. 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. 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.
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 Securities and Exchange Commission. As a result, the Company did not
record any liabilities associated with the registration rights agreement at
June
30, 2006. At December 31, 2006, the Company determined that the registration
statement covering the shares sold in the private placement would not be
declared effective within the requisite time frame and therefore accrued six
months liquidated damages under the registration rights agreement aggregating
approximately $74,000, which has been presented as a current liability at June
30, 2008 and December 31, 2007. The Company’s registration statement on Form
SB-2 was declared effective by the Securities and Exchange Commission on May
14,
2007. At June 30, 2008, the registration penalty to the investors was still
due
and payable.
On
December 12, 2007, the Company sold an aggregate of 999,995 shares of its common
stock to accredited investors in a second private placement at a per share
price
of $0.65, resulting in aggregate gross proceeds to the Company of $650,000.
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 $0.65 per share
and (b) an additional 2% of the number of shares sold in the private placement
also exercisable at $0.65 per share. Net cash proceeds to the Company were
$531,320.
In
conjunction with the second private placement of common stock, the Company
issued a total of 120,000 five-year warrants to WestPark Capital, Inc.
exercisable at the per share price of the common stock sold in the private
placement ($0.65 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 $115,200 ($0.96 per share) using
the
following Black-Scholes input variables: stock price on date of grant - $1.10;
exercise price - $0.65; expected life - 5 years; expected volatility - 118.6%;
expected dividend yield - 0%; risk-free interest rate - 4%.
17
As
part
of the Company’s second private placement of its securities completed on
December 12, 2007, 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 second private placement at its sole cost and expense. The
registration rights agreement terminates at such time as the common shares
may
be sold in market transactions without regard to any volume limitations. The
registration rights agreement requires the Company to file a registration
statement within 75 days of receipt of written demand from holders who represent
at least 50% of the common shares issued pursuant to the second private
placement, provided that no demand shall be made for less than 500,000 shares,
and to use its best efforts to cause such registration statement to become
and
remain effective for the requisite period. The registration rights agreement
also provides for unlimited piggyback registration rights. The registration
rights agreement does not provide for any penalties in the event that the
Company is unable to comply with its terms.
The
Company’s common stock was listed for trading on the OTC Bulletin Board
commencing September 24, 2007.
Since
inception, Lixte’s founding stockholder and Chief Executive Officer, Dr. John
Kovach, has periodically made advances to the Company to meet operating
expenses. Such advances are non-interest-bearing and are due on demand. At
June
30, 2008 and December 31, 2007, stockholder advances totaled
$92,717.
The
Company’s office facilities have been provided without charge by Dr. Kovach.
Such costs were not material to the financial statements and, accordingly,
have
not been reflected therein.
Dr.
Kovach is involved in other business activities and may, in the future, become
involved in other business opportunities that become available. Accordingly,
he
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 and Warrants
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 three months ended June 30,
2008
and 2007, the Company recorded a charge to operations of $5,165 and $5,167,
respectively, with respect to these options. During the six months ended
June 30, 2008 and 2007, the Company recorded a charge to operations of $10,332
and $10,334, respectively, with respect to these
options.
18
On
June
30, 2006, effective with the closing of the Exchange, the Company also granted
to Dr. Palmedo additional stock options to purchase 190,000 shares of
common stock exercisable for a period of five years at $0.333 per share for
services rendered in developing the business plan for Lixte, all of which were
fully vested upon issuance. The fair value of these options, as calculated
pursuant to the Black-Scholes option-pricing model, was determined to be $58,900
($0.31 per share), and was charged to operations at June 30, 2006.
On
June
30, 2006, effective with the closing of the Exchange, the Company granted to
certain members of its Scientific Advisory Committee stock options to purchase
an aggregate of 100,000 shares of common stock exercisable for a period of
five
years at $0.333 per share, with one-half of the options vesting annually on
each
of June 30, 2007 and June 30, 2008. The fair value of these options, as
calculated pursuant to the Black-Scholes option-pricing model, was initially
determined to be $31,000 ($0.31 per share), and is being charged to operations
ratably from July 1, 2006 through June 30, 2008. On June 30, 2008 and 2007,
the
fair value of these options, as calculated pursuant to the Black-Scholes
option-pricing model, was determined to be $25,000 ($0.25 per share) and $29,000
($0.29 per share), respectively, which resulted in a charge (credit) to
operations of $(17,930) and $3,626 during the three months ended June 30, 2008
and 2007, respectively. During the six months ended June 30, 2008 and 2007,
the
Company recorded a charge (credit) to operations of $(3,336) and $7,376,
respectively, with respect to these options.
On
June
30, 2006, the fair value of the aforementioned stock options was initially
calculated using the following Black-Scholes input variables: stock price -
$0.333; exercise price - $0.333; expected life - 5 to 7 years; expected
volatility - 150%; expected dividend yield - 0%; risk-free interest rate -
5%.
On June 30, 2007, the Black-Scholes input variables utilized to determine the
fair value of the aforementioned stock options were stock price - $0.333;
exercise price - $0.333; expected life - 4 to 6 years; expected volatility
-
150%; expected dividend yield - 0%; risk-free interest rate - 4.5%. On June
30,
2008, the fair value of the aforementioned stock options was calculated using
the following Black-Scholes input variables: stock price - $0.30; exercise
price
- $0.333; expected life - 3 to 5 years; expected volatility - 154.5%; expected
dividend yield - 0%; risk-free interest rate - 3.28%.
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, in conjunction with his appointment as a director of the
Company, the Company granted to Dr. Stephen Carter stock options to purchase
an
aggregate of 200,000 shares of common stock under the 2007 Plan, 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), and
is
being charged to operations ratably from September 12, 2007 through September
12, 2009, which resulted in a charge to operations of $25,361 and $50,722 during
the three months and six months ended June 30, 2008, respectively.
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 shares) vesting
on
September 12, 2008. The fair value of these options, as calculated pursuant
to
the Black-Scholes option-pricing model, was initially determined to be $945,000
($0.945 per share), of which $465,000 was attributed to the fully-vested options
and was thus charged to operations on September 12, 2007. The remaining portion
of the fair value of these options is being charged to operations ratably from
September 12, 2007 through September 12, 2008. During the three months and
six
months ended June 30, 2008, the Company recorded a charge (credit) to operations
of $(112,951) and $7,076, respectively, with respect to these
options.
19
On
September 12, 2007, the Company entered into a consulting agreement with Francis
Johnson, a co-owner of Chem-Master International, Inc. 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 initially determined to be $300,000
($1.00 per share), and is being charged to operations ratably from September
12,
2007 through September 12, 2010. On June 30, 2008, the fair value of these
options, as calculated pursuant to the Black-Scholes option-pricing model,
was
determined to be $81,000 ($0.27 per share), which resulted in a charge (credit)
to operations of $(25,139) and $1,705 during the three months and six months
ended June 30, 2008, respectively.
In
accordance with EITF 96-18, options granted to committee members and outside
consultants are revalued each reporting period to determine the amount to be
recorded as an expense in the respective period. As the options vest, they
are
valued on each vesting date and an adjustment is recorded for the difference
between the value already recorded and the then current value on the date of
vesting.
On
September 12, 2007, the fair value of the aforementioned stock options was
initially calculated using the following Black-Scholes input variables: stock
price - $1.05; exercise price - $0.333 to $1.00; expected life - 4 to 6 years;
expected volatility - 150%; expected dividend yield - 0%; risk-free interest
rate - 5%. On June 30, 2008, the fair value of the aforementioned stock options
was calculated (for stock options revalued pursuant to EITF 98-16) using the
following Black-Scholes input variables: stock price - $0.30; exercise price
-
$0.333 to $1.00; expected life - 4.2 years; expected volatility - 154.5%;
expected dividend yield - 0%; risk-free interest rate - 3.28%. The Company
used
a revised volatility factor at June 30, 2008 as it had trading data commencing
September 24, 2007.
Additional
information with respect to common stock warrants and stock options issued
is
provided at Notes 3 and 7.
7. Commitments
and Contingencies
Effective
March 22, 2006, Lixte entered into a CRADA, as amended, with the NINDS of the
NIH. The CRADA is for a term of 42 months 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 $200,000 was due within 180 days of
the
effective date and was paid in full on July 6, 2006. The second $200,000 was
paid in full on June 29, 2007. In June 2008, the CRADA was extended to September
30, 2009 with no additional funding required for the period between July 1,
2008
and September 30, 2008. However, for the period from October 1, 2008 through
September 30, 2009, the Company has agreed to provide additional funding under
the CRADA of $200,000, to be paid in four quarterly installments of $50,000
commencing on October 1, 2008.
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 also agreed
to
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. On January 12, 2008, Lixte
terminated the Services Agreement in accordance with its terms, as a result
of
which payment of the second installment of 36,000 Euros was cancelled. The
University agreed to deliver 50% of the aforementioned samples under the
terminated Services Agreement.
On
February 5, 2007, Lixte entered into a two-year agreement (the “Chem-Master
Agreement”) with Chem-Master International, Inc. (“Chem-Master”), a company
co-owned by Francis Johnson, a consultant to the Company, 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 Chem-Master 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 year ended December 31, 2007, since the option
was fully vested and non-forfeitable on the date of issuance. Lixte has
the right to terminate the Chem-Master Agreement at any time during its term
upon sixty days prior written notice. On February 5, 2009, provided that
the Chem-Master Agreement has not been terminated prior to such date, the
Company has 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.
20
On
January 29, 2008, the Chem-Master Agreement was amended to extend its term
to
February 15, 2014, and to expressly provide for the design and synthesis of
a
new series of compounds designated as “LB-3”. Pursuant to the amendment, Lixte
issued 100,000 shares of its restricted common stock, valued at $75,000, and
granted an option to Chem-Master to purchase 200,000 shares of the Company’s
common stock. The option is exercisable for a period of two years from the
vesting date at $1.65 per share, with one-half (100,000 shares) vesting on
August 1, 2009, and one-half (100,000 shares) vesting on February 1, 2011.
The
fair value of this option, as calculated pursuant to the Black-Scholes
option-pricing model, was initially determined to be $96,000 ($0.48 per share)
using the following Black-Scholes input variables: stock price on date of grant
- $0.75; exercise price - $1.65; expected life - 5 years; expected volatility
-
120.1%; expected dividend yield - 0%; risk-free interest rate -
3.09%.
The
fair
value of the restricted common stock issued was charged to operations as
research and development costs on January 29, 2008. On June 30, 2008, the fair
value of the aforementioned stock options was determined to be $48,000 ($0.24
per share calculated using the following Black-Scholes input variables: stock
price - $0.30; exercise price - $1.65; expected life - 4.59 years; expected
volatility - 154.5%; expected dividend yield - 0%; risk-free interest rate
-
3.28%, which resulted in a charge (credit) to operations of $(425) and $6,664
during the three months and six months ended June 30, 2008, respectively.
On
September 12, 2007, the Company entered into two consulting agreements for
financial and scientific services. Compensation related to these agreements
is
primarily in the form of stock options (see Note 6).
On
September 20, 2007, the Company entered into a one-year consulting agreement
(the “Mirador Agreement”) with Mirador Consulting, Inc. (“Mirador”), pursuant to
which Mirador was to provide the Company with various financial services.
Pursuant to the Mirador 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 on the transaction date, and
was
charged to operations as stock-based compensation during the year ended December
31, 2007, since the shares were fully vested and non-forfeitable on the date
of
issuance. The Company made payments under the Mirador Agreement aggregating
$10,000 during 2007. The Mirador Agreement was amended in February 2008 such
that Mirador forgave all accrued but unpaid monthly fees through February 29,
2008 and the Company agreed to pay Mirador a fee of $2,000 per month for the
remaining six months of the Mirador Agreement.
21
Overview
On
June
30, 2006, Lixte Biotechnology, Inc., a privately-held Delaware corporation
(“Lixte”), completed a reverse merger transaction with SRKP 7, Inc. (“SRKP”), a
non-trading 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.
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.
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
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. The Company’s
ability to continue as a going concern is dependent upon its ability to develop
additional sources of capital and to ultimately achieve profitable operations.
The financial statements do not include any adjustments that might result from
the outcome of these uncertainties (see “Liquidity and Capital Resources - June
30, 2008 - Going Concern”).
Recent
Developments
On
April
23, 2008, the Company announced that Dr. Jie Lu and Dr. Zhengping Zhuang of
the
Surgical Neurology Branch, National Institute of Neurological Disorders and
Stroke, National Institutes of Health and the Company, as a collaborator in
such
study, reported at the Annual Meeting of the American Association of Cancer
Research that the Company’s lead compound, LB-1, one of a patent-pending
proprietary series of agents, has anti-cancer activity against human
glioblastoma multiforme cells in a mouse model of cancer. Glioblastoma
multiforme is the most common and aggressive brain tumor of adults. The Company
and the Surgical Neurology Branch of the National Institute of Neurological
Disorders and Stroke are continuing to develop LB-1 and analogs of the compound
for the treatment of human brain cancers.
On
August
8, 2008, the Company announced that lead compounds from each of two different
types of drugs being developed by it as a potential treatment for specific
types
of brain cancers have activity against human pancreatic cancers in a mouse
model. The Company had previously reported that lead compounds from each of
two
different classes of pharmacologic agents have significant inhibitory activity
against several types of human cancers in the test tube and against brain
cancers in animal models. The Company has now found that two different lead
compounds also have statistically significant activity against human pancreatic
cancer cells growing in mice. These are early studies and there is no evidence
that these drugs are able to eliminate pancreatic cancers, but rather slow
their
growth.
On
August
1, 2008, five patent applications were filed with regard to the Company’s
various ongoing research activities.
22
Adoption
of New Accounting Policies
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 (“GAAP”). 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 American Institute of Certified
Public Accountants (“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 was effective January 1, 2008,
and did
not have any impact on the Company’s financial statement presentation or
disclosures in 2008.
In
February 2007, the FASB issued Statement of Financial Accounting Standards
No. 159, “The Fair Value Option for Financial Assets and Financial
Liabilities” (“SFAS No. 159”), which provides companies with an option
to report selected financial assets and liabilities at fair value.
SFAS No. 159’s objective is to reduce both complexity in accounting
for financial instruments and the volatility in earnings caused by measuring
related assets and liabilities differently. Generally accepted accounting
principles have required different measurement attributes for different assets
and liabilities that can create artificial volatility in earnings.
SFAS No. 159 helps to mitigate this type of accounting-induced
volatility by enabling companies to report related assets and liabilities at
fair value, which would likely reduce the need for companies to comply with
detailed rules for hedge accounting. SFAS No. 159 also establishes
presentation and disclosure requirements designed to facilitate comparisons
between companies that choose different measurement attributes for similar
types
of assets and liabilities. SFAS No. 159 requires companies to provide
additional information that will help investors and other users of financial
statements to more easily understand the effect of the company’s choice to use
fair value on its earnings. SFAS No. 159 also requires companies to
display the fair value of those assets and liabilities for which the company
has
chosen to use fair value on the face of the balance sheet.
SFAS No. 159 does not eliminate disclosure requirements included in
other accounting standards, including requirements for disclosures about fair
value measurements included in SFAS No. 157 and
SFAS No. 107. SFAS No. 159 was effective January 1, 2008,
and
did not
have any impact on the Company’s financial statement presentation or disclosures
in 2008.
Recent
Accounting Pronouncements
In
December 2007, the FASB issued SFAS No. 141(R), “Business
Combinations” (“SFAS No. 141(R)”), which requires an acquirer to
recognize in its financial statements as of the acquisition date (i) the
identifiable assets acquired, the liabilities assumed, and any noncontrolling
interest in the acquiree, measured at their fair values on the acquisition
date,
and (ii) goodwill as the excess of the consideration transferred plus the
fair value of any noncontrolling interest in the acquiree at the acquisition
date over the fair values of the identifiable net assets acquired.
Acquisition-related costs, which are the costs an acquirer incurs to effect
a
business combination, will be accounted for as expenses in the periods in which
the costs are incurred and the services are received, except that costs to
issue
debt or equity securities will be recognized in accordance with other applicable
GAAP. SFAS No. 141(R) makes significant amendments to other Statements
and other authoritative guidance to provide additional guidance or to conform
the guidance in that literature to that provided in SFAS No. 141(R).
SFAS No. 141(R) also provides guidance as to what information is to be
disclosed to enable users of financial statements to evaluate the nature and
financial effects of a business combination. SFAS No. 141(R) is
effective for financial statements issued for fiscal years beginning on or
after
December 15, 2008. Early adoption is prohibited. The
adoption of SFAS No. 141(R) will affect how the Company accounts for a
business combination concluded after December 31, 2008.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests
in Consolidated Financial Statements — an amendment of ARB No. 51”
(“SFAS No. 160”), which revises the relevance, comparability, and
transparency of the financial information that a reporting entity provides
in
its consolidated financial statements by establishing accounting and reporting
standards that require (i) the ownership interests in subsidiaries held by
parties other than the parent be clearly identified, labeled, and presented
in
the consolidated statement of financial position within equity, but separate
from the parent’s equity, (ii) the amount of consolidated net income
attributable to the parent and to the noncontrolling interest be clearly
identified and presented on the face of the consolidated statement of income,
(iii) changes in a parent’s ownership interest while the parent retains its
controlling financial interest in its subsidiary be accounted for consistently
as equity transactions, (iv) when a subsidiary is deconsolidated, any
retained noncontrolling equity investment in the former subsidiary be initially
measured at fair value, with the gain or loss on the deconsolidation of the
subsidiary being measured using the fair value of any noncontrolling equity
investment rather than the carrying amount of that retained investment, and
(v) entities provide sufficient disclosures that clearly identify and
distinguish between the interests of the parent and the interests of the
noncontrolling owners. SFAS No. 160 amends FASB No. 128 to
provide that the calculation of earnings per share amounts in the consolidated
financial statements will continue to be based on the amounts attributable
to
the parent. SFAS No. 160 is effective for financial statements issued
for fiscal years, and interim periods within those fiscal years, beginning
on or
after December 15, 2008. Early adoption is prohibited.
SFAS No. 160 shall be applied prospectively as of the beginning of the
fiscal year in which it is initially applied, except for the presentation and
disclosure requirements, which shall be applied retrospectively for all periods
presented. The Company has not yet determined the effect on its consolidated
financial statements, if any, upon adoption of SFAS No. 160.
23
In
March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments
and Hedging Activities - an amendment of FASB Statement No. 133” (“SFAS No.
161”). SFAS No. 161 amends and expands the disclosure requirements of SFAS No.
133, “Accounting for Derivative Instruments and Hedging Activities” (“SFAS No.
133”). The objective of SFAS No. 161 is to provide users of financial statements
with an enhanced understanding of how and why an entity uses derivative
instruments, how derivative instruments and related hedged items are accounted
for under SFAS No. 133 and its related interpretations, and how derivative
instruments and related hedged items affect an entity’s financial position,
financial performance, and cash flows. SFAS No. 161 requires qualitative
disclosures about objectives and strategies for using derivatives, quantitative
disclosures about fair value amounts of and gains and losses on derivative
instruments, and disclosures about credit-risk-related contingent features
in
derivative agreements. SFAS No. 161 applies to all derivative financial
instruments, including bifurcated derivative instruments (and nonderivative
instruments that are designed and qualify as hedging instruments pursuant to
paragraphs 37 and 42 of SFAS No. 133) and related hedged items accounted for
under SFAS No. 133 and its related interpretations. SFAS No. 161 also amends
certain provisions of SFAS No. 131. SFAS No. 161 is effective for financial
statements issued for fiscal years and interim periods beginning after November
15, 2008, with early application encouraged. SFAS No. 161 encourages, but does
not require, comparative disclosures for earlier periods at initial adoption.
The Company has not yet determined the effect on its consolidated financial
statements, if any, upon adoption of SFAS No. 161.
Critical
Accounting Policies and Estimates
The
Company prepared its 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, patent fees and costs, 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.
24
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, including patent-related
legal fees, are expensed as incurred.
Stock-Based
Compensation
Effective
January 1, 2006, the Company adopted SFAS No. 123 (revised 2004), "Share-Based
Payment" ("SFAS No. 123R"), a revision to SFAS No. 123, "Accounting for
Stock-Based Compensation". SFAS No. 123R 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 stock option and warrant grants issued and vesting to
non-employees in accordance with EITF No. 96-18, “Accounting for Equity
Instruments that are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services”, and EITF 00-18, “Accounting
Recognition for Certain Transactions involving Equity Instruments Granted to
Other Than Employees”, whereas the value of the stock compensation is based upon
the measurement date as determined at either (a) the date at which a performance
commitment is reached or (b) at the date at which the necessary performance
to
earn the equity instruments is complete.
The
Company accounts for income taxes pursuant to Statement of Financial Accounting
Standards No. 109, “Accounting for Income Taxes” (“SFAS No. 109”), which
establishes financial accounting and reporting standards for the effects of
income taxes that result from an enterprise’s activities during the current and
preceding years. SFAS No. 109 requires an asset and liability approach for
financial accounting and reporting for income taxes. Accordingly, the Company
recognizes deferred tax assets and liabilities for the expected impact of
differences between the financial statements and the tax basis of assets and
liabilities.
The
Company records a valuation allowance to reduce its deferred tax assets to
the
amount that is more likely than not to be realized. In the event the Company
was
to determine that it would be able to realize its deferred tax assets in the
future in excess of its recorded amount, an adjustment to the deferred tax
assets would be credited to operations in the period such determination was
made. Likewise, should the Company determine that it would not be able to
realize all or part of its deferred tax assets in the future, an adjustment
to
the deferred tax assets would be charged to operations in the period such
determination was made.
Plan
of Operation
General
Overview of Plans
The
Company is 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.
The
Company is currently focusing on developing new treatments for the most common
and most aggressive type of brain cancer of adults, glioblastoma multiforme
(“GBM”). The Company has expanded the scope of its anti-cancer investigational
activities to include the most common brain tumor of children, medulloblastoma,
and also to several other types of more common cancers. This expansion of
activity is based on documentation that each of two distinct types of drugs
being developed by the Company inhibits the growth of cell lines of breast,
colon, lung, prostate, pancreas, ovary, stomach and liver cancer, as well as
the
major types of leukemias. Activity of lead compounds of both types of drugs
was
recently demonstrated against human pancreatic cancer cells in a mouse model.
Because there is a great need for any kind of effective treatment for pancreatic
cancer, this cancer will be studied concomitantly with the primary target of
the
Company’s research program focused on brain cancers.
25
The
research on brain tumors is proceeding in collaboration with the National
Institute of Neurological Disorders and Stroke (“NINDS”) of the National
Institutes of Health (“NIH”) under a Cooperative Research and Development
Agreement (“CRADA”) entered into on March 22, 2006, as amended. The research at
NINDS continues to be led by Dr. Zhengping Zhuang, an internationally recognized
investigator in the molecular pathology of cancer. Dr. Zhuang is aided by two
senior research technicians supported by the Company as part of the CRADA.
The
goal of the CRADA is to develop more effective drugs for the treatment of GBM
through the processes required to gain Food and Drug Administration (“FDA”)
approval for clinical trials. The CRADA was further amended on June 17, 2008.
Accordingly, the Company is committed to provide funding of $600,000 under
the
CRADA over a period of 42 months, of which $400,000 had been paid as of June
30,
2008 and the remaining $200,000 is to be paid in four quarterly installments
of
$50,000 commencing on October 1, 2008. The CRADA is presently scheduled to
end
on September 30, 2009.
The
Company developed five patent applications that were filed on August 1, 2008.
Two of these patent filings deal with applications filed earlier jointly with
NIH for work done under the CRADA: (1) a filing entering the regional stage
of a
PCT application involving the use of certain compounds to treat human tumors
expressing a biomarker for brain and other human cancers, and (2) an application
for the treatment of the pediatric tumors, medulloblastoma (the most common
brain tumor in children) and neuroblastoma (a tumor arising from neural cells
outside the brain that is the most common cancer of children). The three new
patent applications include (1) a joint application with NIH identifying a
new
biomarker for many common human cancers that when targeted by compounds
developed by the Company result in inhibition of growth and death of cancer
cells; (2) an application by the Company regarding the structure, synthesis
and
use of a group of new homologs of its LB-1 compounds; and (3) an application
by
the Company for the use of certain homologs of its drugs as neuroprotective
agents with potential application to common neurodegenerative conditions such
as
Alzheimer’s and Parkinson’s diseases.
The
Company continues to evaluate compounds for activity against several types
of
fungi that cause serious infections, particularly in immuno-compromised
individuals, such as those with HIV-AIDS, and those having bone marrow
transplantations. The Company is also exploring indications that specific
analogy of one class of drugs has activity against strains of fungi that cause
the most common fungal infections of the skin and nails. Discussions are in
progress with experts in fungal infections regarding the most reliable methods
of assessing the potential of new agents for the management of common fungal
diseases.
The
Company expects that its products will derive directly from the intellectual
property from its research activities. The development of lead compounds with
different mechanisms of action that have now been shown to have activity against
brain tumors and several other much more common human cancers, as well as
serious fungal infections, originated from its original focus on a biochemical
defect in GBM. The Company will continue to use discovery and/or recognition
of
molecular variants characteristic of specific human cancers as a guide to drug
discovery and potentially new diagnostic tests. Examples of the productivity
of
this approach to discovery of new therapeutics are (1) the recent patent
application filing for a new bio-marker of several common cancers that when
targeted by certain of the Company’s drugs results in inhibition of growth and
death of cancer cells displaying the marker, and (2) the filing of a patent
on
certain homologs of one group of compounds as potentially useful for the
treatment of neurodegenerative diseases.
The
Company faces several potential challenges to its goal of commercial success.
These include raising sufficient capital to fund its business plan, achieving
commercially applicable results from its research programs, competition from
more established, well-funded companies with competitive technologies, and
future competition from companies developing new competitive technologies.
Because of these challenges, there is substantial uncertainty as to the
Company’s ability to fund its operations and continue as a going concern (see
“Liquidity and Capital Resources - June 30, 2008 - Going Concern”
below).
Plans
for the Remainder of 2008
The
Company’s primary financial goal is to raise funds to cover ongoing operations
and development of its lead compounds for the treatment of brain cancers and
to
also include another devastating human cancer, pancreatic cancer, in its
research efforts. The Company’s objective is to have sufficient resources
available to explore, most likely in partnership with a pharmaceutical company,
new data indicating potentially significant activity of some derivatives of
its
lead anti-cancer drugs for the management of fungal diseases and, possibly,
use
in neurodegenerative diseases where pharmacologic neuroprotection may be
therapeutically beneficial.
26
The
Company has three major therapeutic goals, as follows:
The
first
goal is to continue to evaluate lead compounds of the LB-1 and LB-2 series
for
effectiveness in a rat model of brain cancer in which drugs are administered
systemically or by direct infusion into the diseased area of the brain. The
latter method of administration is called “convection administration”. In
addition to its current lead compounds, new analogs designed to have enhanced
penetration of the brain and combinations of current drugs with activity in
the
rat model will be evaluated alone and in combination with other known active
anti-cancer drugs that have complementary activity to Company drugs.
The
second goal is to evaluate the recently documented anti-cancer activity of
lead
compounds from the LB-1 and LB-2 series against a series of common human
cancers. These studies are being done independently of NIH and are therefore
not
part of the CRADA.
The
Company will seek the interest of NIH in supporting development of one or two
lead compounds from the LB-1 series through pre-clinical studies necessary
to
receive FDA approval to take the drugs into Phase I clinical trials. The NIH
offers opportunities for academic laboratories, including laboratories at NIH
with a for-profit partner, to seek NIH support and expertise in expediting
development of particularly promising new compounds as anti-cancer drugs. The
Company will also explore the potential interest of major pharmaceutical
companies in collaborating in the development of one or more of its lead
compounds through Phase I clinical trials of their anti-cancer activity.
The
third
goal is to assess the interest of pharmaceutical companies in collaborating
with
the Company or in licensing from the Company rights to some of its lead
compounds as anti-fungal drugs. Certain molecular pathways essential for growth
by cancer cells are also used by microorganisms, including fungi. Anti-fungal
therapy is an additional potentially large market for the Company’s compounds,
but one in which outside expertise will be necessary to plan efficient
assessment and development of their potential value.
Existing
resources will not permit evaluation of activity of the Company’s lead drugs
against many of the common cancers against which the Company’s compounds may
have anti-cancer activity. Current resources also will not be sufficient to
carry out pre-clinical studies necessary to apply to the FDA for approval of
drug evaluations in Phase I trials. Accordingly, the Company is seeking to
raise
approximately $2,000,000 from the issuance of new debt and/or equity during
the
latter part of 2008 in order to fund its planned operations in 2009. However,
there can be no assurances that the Company will be able to secure such
additional financing, or obtain favorable terms on such financing if it is
available.
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, competition
from more established, well-funded companies with competitive technologies,
and
future competition from companies that are developing competitive technologies,
some of whom are larger companies with greater capital resources than the
Company. There is substantial uncertainty as to the Company’s ability to fund
its operations and continue as a going concern (see “Liquidity and Capital
Resources - June 30, 2008 - Going Concern”). Should the Company be unable to
raise the required capital on a timely basis, the Company’s business plans would
be materially adversely affected.
The
Company had initially 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 a laboratory. The Company had
estimated that the creation and operation of such a laboratory for two years
would cost approximately $2,000,000. The Company has revised its research plans
as described above, as a result of which it has deferred such plans to open
and
staff such a laboratory indefinitely.
27
Plans
for 2009
A
goal of
the Company is to continue the synthesis of new compounds that target other
components of molecular pathways already identified by the Company to be
vulnerable to attack by small molecule drugs, and to explore the vulnerability
of additional potential new targets revealed through the molecular
characterization of the effects of the Company’s lead compounds.
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 to 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, 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 in 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 the new regimen to the FDA.
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 Investigational New Drug (“IND”) application 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.
On
January 29, 2008, the Chem-Master Agreement was amended to extend its term
to
February 15, 2014, pursuant to which Chem-Master was engaged to synthesize
certain compounds, and to expressly provide for the expansion of the Company’s
drug development program, through consultation with the medicinal chemists
at
Chem-Master. The Company is exploring the synthesis of additional novel
anti-cancer drugs. Several targets for anti-cancer drug development are under
consideration. When the next group of compounds is developed, it will be
designated as “LB-3”, as distinguished from the first two classes of compounds
that were designated as “LB-1” and “LB-2”. This process is currently in the
planning stage and no compounds have been made as yet.
Results
of Operations
The
Company is a development stage company and had not commenced revenue-generating
operations at June 30, 2008.
Three
Months Ended June 30, 2008 and 2007
General
and Administrative Expenses.
For the
three months ended June 30, 2008, general and administrative expenses were
$(50,947), which consisted of a credit to stock-based compensation of $100,355,
and charges to consulting and professional fees of $34,060, insurance expense
of
$5,955, travel costs of $2,235, and other operating costs of $7,158. The Company
recorded a credit with respect to stock-based general and administrative
expenses during the three months ended June 30, 2008 as a result of a decrease
in the fair value of unvested stock options resulting from a decline in the
market price of the Company’s common stock during the period.
28
For
the
three months ended June 30, 2007, general and administrative expenses were
$89,241, which consisted of stock-based compensation of $8,791, consulting
and
professional fees of $62,304, insurance expense of $7,188, filing fees of
$5,101, and other operating costs of $5,857.
Depreciation.
For the
three months ended June 30, 2008 and 2007, depreciation expense was $159 and
$148, respectively.
Research
and Development Costs.
For the
three months ended June 30, 2008, research and development costs were $61,782,
which consisted of a credit for the vested portion of the fair value of stock
options issued to a consultant and a vendor of $25,564, and charges for patent
costs of $34,224, laboratory supplies of $15,500, and other costs of $37,622.
The Company recorded a credit with respect to stock-based research and
development costs during the three months ended June 30, 2008 as a result of
a
decrease in the fair value of unvested stock options resulting from a decline
in
the market price of the Company’s common stock during the period.
For
the
three months ended June 30, 2007, research and development costs were $89,917,
which consisted of patent costs of $6,592, laboratory supplies of $8,400, and
other costs of $74,925.
Interest
Income.
For the
three months ended June 30, 2008, interest income was $733, as compared to
interest income of $3,584 for the three months ended June 30,
2007.
Net
Loss.
For the
three months ended June 30, 2008, the Company incurred a net loss of $10,261,
as
compared to a net loss of $175,722 for the three months ended June 30,
2007.
Six
Months Ended June 30, 2008 and 2007
General
and Administrative Expenses.
For the
six months ended June 30, 2008, general and administrative expenses were
$217,869, which consisted of stock-based compensation of $64,794, consulting
and
professional fees of $105,785, insurance expense of $11,911, travel costs of
$20,223, and other operating costs of $15,156.
For
the
six months ended June 30, 2007, general and administrative expenses were
$199,244, which consisted of stock-based compensation of $17,708, consulting
and
professional fees of $149,264, insurance expense of $14,375, filing fees of
$8,295, and other operating costs of $9,602.
Depreciation.
For the
six months ended June 30, 2008 and 2007, depreciation expense was $318 and
$296,
respectively.
Research
and Development Costs.
For the
six months ended June 30, 2008, research and development costs were $298,233,
which consisted of the fair value of restricted common stock issued to a vendor
of $75,000, the vested portion of the fair value of stock options issued to
a
consultant and a vendor of $8,369, patent costs of $74,224, laboratory supplies
of $24,250, and other costs of $116,390.
For
the
six months ended June 30, 2007, research and development costs were $237,592,
which consisted of the vested portion of the fair value of stock options issued
to a vendor of $31,000, patent costs of $46,592, laboratory supplies of $10,150,
and other costs of $149,850.
Interest
Income.
For the
six months ended June 30, 2008, interest income was $2,838, as compared to
interest income of $8,307 for the six months ended June 30,
2007.
Net
Loss.
For the
six months ended June 30, 2008, the Company incurred a net loss of $513,582,
as
compared to a net loss of $428,825 for the six months ended June 30,
2007.
29
Liquidity
and Capital Resources - June 30, 2008
Going
Concern
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.
The
Company’s ability to continue as a going concern is dependent upon its ability
to develop additional sources of capital and to ultimately achieve profitable
operations. The accompanying financial statements do not include any adjustments
that might result from the outcome of these uncertainties.
The
Company is currently devoting its efforts to research and development related
to
discovering specific cancer biomarkers for early detection, estimation of
prognosis, monitoring response to treatment, development of targeted therapeutic
agents and new treatments based on an understanding of the molecular activity
of
these biomarkers for common cancers. The Company is seeking to exploit this
opportunity through execution of its business plan and the development of
related patents.
At
June
30, 2008, the Company had not yet commenced any revenue-generating operations.
All activity through June 30, 2008 is 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 a 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 the
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. On December 12, 2007, the
Company completed a second private placement, selling 999,995 shares of common
stock at a price of $0.65 per share and receiving net proceeds of
$531,320.
Because
the Company is currently engaged in research at an 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’s current resources are marginally adequate to fund the Company’s
basic operating budget through December 31, 2008, but are not sufficient to
fund
expanded research activities with respect to the Company’s promising
intellectual property during the remainder of 2008 and beyond. The Company
does
not have sufficient resources to fully develop and commercialize any products
that may arise from its research. Accordingly, the Company will need to raise
additional funds in order to satisfy its future working capital requirements.
Based
on
the Company’s revised and updated research program, the Company currently
estimates that it will require additional funds of approximately $2,000,000
for
the year ending December 31, 2009 in order to fund operations and continuing
drug discovery and to bring one drug through the pre-clinical evaluation process
needed for submission of an IND. The Company is attempting to arrange such
funding during the next few months, although there can be no assurances that
the
Company will be successful in this regard. The amount and timing of future
cash
requirements will depend on the market’s evaluation of the Company’s technology
and products, and the resources that the Company devotes to developing and
supporting its activities. The Company anticipates funding these cash
requirements from a combination of debt or equity financings and the sale,
licensing or joint venturing 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, as a result of which 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 technology and product development
programs, or obtain funds, if available, through strategic alliances that may
require the Company to relinquish rights to certain of its technologies
products, or to discontinue its operations entirely.
30
Operating
Activities.
For the
six months ended June 30, 2008, operating activities utilized cash of $306,135,
as compared to utilizing cash of $484,697 for the six months ended June 30,
2007, primarily as a result of a decrease in advances on research and
development contract services in 2008, as compared to an increase in advances
on
research and development contract services in 2007 related to an installment
payment made under the CRADA in 2007.
The
Company had working capital of $11,082 at June 30, 2008. At December 31, 2007,
the Company had working capital of $376,184, primarily as a result of the sale
of the Company’s common stock pursuant to a second private placement in December
2007 that generated net proceeds of $531,320.
Investing
Activities.
There
were no investing activities during the six months ended June 30, 2008. For
the
six months ended June 30, 2007, investing activities utilized cash of $272
for
the purchase of office equipment.
Financing
Activities.
There
were no financing activities during the six months ended June 30, 2008 and
2007.
Principal
Commitments
At
June
30, 2008, the Company did not have any material commitments for capital
expenditures. The Company’s principal commitments at June 30, 2008 consisted of
the liquidated damages payable under the registration rights agreement of
$74,000 and the contractual obligations as summarized below.
Effective
March 22, 2006, Lixte entered into a CRADA, as amended, with the NINDS of the
NIH. The CRADA is for a term of 42 months 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 $200,000 was due within 180 days of
the
effective date and was paid in full on July 6, 2006. The second $200,000 was
paid in full on June 29, 2007. In June 2008, the CRADA was extended to September
30, 2009 with no additional funding required for the period between July 1,
2008
and September 30, 2008. However, for the period from October 1, 2008 through
September 30, 2009, the Company has agreed to provide additional funding under
the CRADA of $200,000, to be paid in four quarterly installments of $50,000
commencing on October 1, 2008.
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 also agreed
to
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. On January 12, 2008, Lixte
terminated the Services Agreement in accordance with its terms, as a result
of
which payment of the second installment of 36,000 Euros was cancelled. The
University agreed to deliver 50% of the aforementioned samples under the
terminated Services Agreement.
On
February 5, 2007, Lixte entered into a two-year agreement (the “Chem-Master
Agreement”) with Chem-Master International, Inc. (“Chem-Master”), a company
co-owned by Francis Johnson, a consultant of the Company, 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 Chem-Master 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
Chem-Master Agreement at any time during its term upon sixty days prior written
notice. On February 5, 2009, provided that the Chem-Master Agreement has
not been terminated prior to such date, the Company has 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.
31
On
January 29, 2008, the Chem-Master Agreement was amended to extend its term
to
February 15, 2014, and to expressly provide for the design and synthesis of
a
new series of compounds designated as “LB-3”. Pursuant to the amendment, Lixte
issued 100,000 shares of its restricted common stock, valued at $75,000, and
granted an option to Chem-Master to purchase 200,000 shares of the Company’s
common stock. The option is exercisable for a period of two years from vesting
date at $1.65 per share, with one-half (100,000 shares) vesting on August 1,
2009, and one-half (100,000 shares) vesting on February 1, 2011.
On
September 20, 2007, the Company entered into a one-year consulting agreement
(the “Mirador Agreement”) with Mirador Consulting, Inc. (“Mirador”), pursuant to
which Mirador was to provide the Company with various financial services.
Pursuant to the Mirador 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 Company made payments under the
Mirador Agreement aggregating $10,000 during 2007. The Mirador Agreement was
amended in February 2008 such that Mirador forgave all accrued but unpaid
monthly fees through February 29, 2008 and the Company agreed to pay Mirador
a
fee of $2,000 per month for the remaining six months of the Mirador
Agreement.
Off-Balance
Sheet Arrangements
At
June
30, 2008, the Company did not have any transactions, obligations or
relationships that could be considered off-balance sheet
arrangements.
32
ITEM 3. |
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
Not
applicable.
ITEM 4T. |
CONTROLS
AND PROCEDURES
|
(a) Evaluation
of Disclosure Controls and Procedures
Disclosure
Controls and procedures are designed to ensure that information required to
be
disclosed in the reports filed or submitted under the Exchange Act is recorded,
processed, summarized and reported, within the time periods specified in the
Securities and Exchange Commission’s rules and forms. Disclosure controls and
procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed in the reports filed under
the
Exchange Act is accumulated and communicated to management.
As
of
June 30, 2008, 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.
33
PART
II. OTHER INFORMATION
Item
1.
Legal Proceedings
The
Company is currently not a party to any pending or threatened legal
proceedings.
Item
1A.
Risk Factors
Not
applicable.
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
Not
applicable.
Not
applicable.
Item
4.
Submission of Matters to a Vote of Security Holders
Not
applicable.
Item
5.
Other Information
Not
applicable.
Item
6.
Exhibits
A
list of
exhibits required to be filed as part of this report is set forth in the Index
to Exhibits, which immediately precedes such exhibits, and is incorporated
herein by reference.
34
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:
August 12, 2008
|
By:
|
/s/ JOHN
S. KOVACH
|
|
|
John
S. Kovach
|
|
|
Chief
Executive Officer and Chief Financial Officer
|
|
|
(Principal
financial and accounting officer)
|
35
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, previously filed as an exhibit to
the
Company’s Quarterly Report on Form 10-QSB for the Quarterly Period Ended
September 30, 2007, and incorporated herein by
reference.
|
|
|
|
10.5
|
|
Stock
Option Agreement between Lixte Biotechnology Holdings, Inc. and Francis
Johnson dated September 12, 2007, previously filed as an exhibit
to the
Company’s Quarterly Report on Form 10-QSB for the Quarterly Period Ended
September 30, 2007, and incorporated herein by
reference.
|
|
|
|
10.6
|
|
Stock
Option Agreement between Lixte Biotechnology Holdings, Inc. and Gil
Schwartzberg dated September 12, 2007, previously filed as an exhibit
to
the Company’s Quarterly Report on Form 10-QSB for the Quarterly Period
Ended September 30, 2007, and incorporated herein by
reference.
|
|
|
|
10.7
|
|
Consulting
Agreement between Lixte Biotechnology Holdings, Inc. and Gil Schwartzberg
dated September 12, 2007, previously filed as an exhibit to the Company’s
Quarterly Report on Form 10-QSB for the Quarterly Period Ended September
30, 2007, and incorporated herein by reference.
|
|
|
|
10.8
|
|
Consulting
Agreement between Lixte Biotechnology Holdings, Inc. and Mirador
Consulting, Inc. dated September 20, 2007, previously filed as an
exhibit
to the Company’s Quarterly Report on Form 10-QSB for the Quarterly Period
Ended September 30, 2007, and incorporated herein by
reference.
|
|
|
|
10.9
|
|
Consulting
Agreement between Lixte Biotechnology Holdings, Inc. and Francis
Johnson
dated September 12, 2007, previously filed as an exhibit to the Company’s
Quarterly Report on Form 10-QSB for the Quarterly Period Ended September
30, 2007, and incorporated herein by reference.
|
|
|
|
10.10
|
|
Amendment
to Agreement between Lixte Biotechnology Holdings, Inc. and Chem-Master
International, Inc. dated January 29, 2008, previously filed as an
exhibit
to the Company’s Quarterly Report on Form 10-Q for the Quarterly Period
Ended March 31, 2008, and incorporated herein by reference.
|
|
|
|
10.11
|
Amendment
No. 5 to Cooperative Research and Development Agreement between The
National Institute of Neurological Disorders and Stroke and Lixte
Biotechnology, Inc. dated June 17, 2008. (1)
|
|
31.1
|
|
Certifications
under Section 302 of the Sarbanes-Oxley Act of 2002.
(1)
|
|
|
|
32.1
|
|
Certifications
under Section 906 of the Sarbanes-Oxley Act of 2002.
(1)
|
(1)
|
Filed
herewith.
|
36