8-K: Current report filing
Published on July 7, 2006
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
Current
Report Pursuant to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
Date
of
Report (Date of Earliest Event Reported): June 30, 2006
SRKP
7,
INC.
(Exact
Name of Registrant as Specified in its Charter)
Delaware
000-51476
|
20-2903526
|
|
(Commission
File Number)
|
(I.R.S.
Employer Identification No.)
|
248
Route 25A, No. 2, East Setauket, New York
|
11733
|
|
(Address of Principal Executive Offices) |
(Zip Code) |
631-942-7959
(Registrant’s
Telephone Number, Including Area Code)
1900
Avenue of the Stars, Los Angeles, CA 90067
Item 2.01
Completion of Acquisition or Disposition of Assets
On
June
30, 2006, pursuant to a Share Exchange Agreement dated as of June 8, 2006 (the
“Share Exchange Agreement”) by and among SRKP 7, Inc. (the “Company”), John S.
Kovach (“Seller”) and Lixte Biotechnology, Inc. (“Lixte”), the Company issued
19,021,786 shares of its common stock in exchange for all of the issued and
outstanding shares of Lixte (the “Exchange” or the “Reverse Merger”). Pursuant
to the terms of the Share Exchange Agreement, there will be approximately
27,527,341 shares of common stock issued and outstanding after giving effect
to
the Exchange and the maximum amount of the private placement as further
described herein under Item 5.01.
As
a
result of the Exchange, Lixte became a wholly owned subsidiary of the Company.
Item 5.01 of this Current Report on Form 8-K, is incorporated by
reference into this Item 2.01.
Item
3.02 Unregistered Sales of Equity Securities
As
described in Item 2.01 of this Current Report on Form 8-K, on June 30, 2006,
the
Company issued 19,021,786 shares of its common stock to Seller in exchange
for
all of the issued and outstanding shares of Lixte. Concurrently with the closing
of the Exchange, the Company sold an aggregate of 1,973,871 shares of its Common
Stock to 26 accredited investors in a private placement (the “Private
“Placement”) at a per share price of $.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 nonaccountable fee of 4% on 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.
The Company anticipates that there will be additional closings for the Private
Placement up to a maximum of $1,500,000.
The
securities were issued by the Company in the Exchange and the Private Placement
in reliance upon an exemption from registration under Section 4(2) of the
Securities Act of 1933, as amended and Regulation D promulgated
thereunder.
Item 5.01.
Changes in Control of Registrant
The
Share Exchange
On
June
30, 2006, the Company issued 19,021,786 shares of its common stock in exchange
for all of the issued and outstanding shares of Lixte. As a result of the
Exchange and Reverse Merger, Lixte became a wholly owned subsidiary of the
Company. The Exchange occurred pursuant to the Share Exchange
Agreement.
Immediately
prior to the Exchange and Reverse Merger, the Company had 4,005,556 outstanding
shares of common stock and no outstanding shares of preferred stock. The
Company’s Certificate of Incorporation provides for authorized capital of
110,000,000 shares of which one hundred million (100,000,000) shares are $0.0001
par value common stock and ten million (10,000,000) shares are $0.0001 par
value
preferred stock.
-1-
Pursuant
to the Exchange, the Company issued to the Seller 19,021,786 shares. Therefore,
the total issued and outstanding shares of the Company’s common stock equals
25,001,213 shares after giving effect to the Exchange and the shares issued
in
the initial closing of the Private Placement.
As
a
result of the Exchange and the shares issued in the initial Private Placement,
(i) the stockholders of the Company immediately prior to the Exchange own
4,005,556 shares, or approximately 16.02% of the issued and outstanding shares
of the Company’s common stock, and (ii) the Company is now controlled by
the former stockholder of Lixte.
The
Share
Exchange Agreement was determined through arms’-length negotiations between the
Company, the Seller and Lixte. In connection with the Exchange, the Company
paid
WestPark Capital, Inc. a cash fee of $45,000.
Change
of Executive Officers and Directors
Immediately
following the completion of the Exchange, all of the existing members of the
Company’s board of directors and all of its executive officers resigned and new
appointees were elected to the Company’s board of directors as set forth
below.
On
June
13, 2006, the Company filed with the Securities and Exchange Commission an
Information Statement pursuant to Section 14(f) of the Securities Exchange
Act of 1934 and Rule 14f-1 thereunder regarding the following change in the
Company’s Board of Directors in accordance with the terms of the Share Exchange
Agreement.
Information
regarding the Company’s directors and executive officers is set forth below. If
any director or executive officer listed below is unable to serve, the directors
will appoint a successor. Each director serves until his successor is elected
at
the annual meeting of stockholders or until his earlier death, resignation
or
removal and each executive officer serves at the pleasure of the Board of
Directors.
Name
|
Age
|
Position
|
Dr.
John S. Kovach
|
69
|
President,
Director
|
Dr.
Philip F. Palmedo
|
72
|
Director
|
We
intend
to add at least one more independent director as soon as possible.
Dr.
John S. Kovach, age
69,
founded Lixte in August, 2005 and is its President and a member of the Board
of
Directors. He received a BA (cum laude) from Princeton University and an MD
(AOA) from the College of Physicians & Surgeons, Columbia University. Dr.
Kovach trained in Internal Medicine and Hematology at Presbyterian Hospital,
Columbia University and spent six years in the laboratory of Chemical Biology,
National Institute of Arthritis and Metabolic diseases studying control of
gene
expression in bacterial systems.
Dr.
Kovach was recruited to Stony Brook University in 2000 to found the Long Island
Cancer Center (now named the Stony Brook University Cancer Center). He is
presently Chair, Department of Preventive Medicine, Stony Brook University,
Stony Brook, New York. From 1994 to 2000, Dr. Kovach was Executive Vice
President for Medical and Scientific Affairs, City of Hope National Medical
Center in Los Angeles, California. His responsibilities included oversight
of
all basic and clinical research initiatives at the City of Hope. During that
time he was also Director of the Beckman Research Center at City of Hope and
a
member of the Arnold and Mabel Beckman Scientific Advisory Board in Newport
Beach, California.
-2-
From
1976
to 1994, Dr. Kovach was a consultant in oncology and director of the Cancer
Pharmacology Division at the Mayo Clinic in Rochester, Minnesota. During this
time, he directed the early clinical trials program for evaluation of new
anti-cancer drugs as principal investigator of contracts from the National
Cancer Institute. From 1986 to 1994, he was also Chair of the Department of
Oncology and Director of the NCI-designated Mayo Comprehensive Cancer Center.
During that time, Dr. Kovach, working with a molecular geneticist, Steve Sommer
MD, PhD, published extensively on patterns of acquired mutations in human cancer
cells as markers of environmental mutagens and as potential indicators of breast
cancer patient prognosis. Dr. Kovach has published over 100 articles on the
pharmacology, toxicity, and effectiveness of anti-cancer treatments and on
the
molecular epidemiology of breast cancer. Dr. Kovach directs Lixte with the
approval of the State University of New York at Stony Brook and the New York
State Ethics Commission.
Chief
Executive Officer
Initially,
leadership and management of the company will be provided by Dr. Kovach with
the
advice of the board of Directors and the Scientific Advisory Committee. The
activities for the first year at least will be confined to achieving the goals
of the CRADA through the collaborative arrangement of the company by which
Dr.
Kovach and Dr. Zhuang, aided by two full time technical personnel, will pursue
development of lead compounds for the treatment of malignant brain tumors.
During the initial year, Dr. Kovach will also oversee the collection of the
clinical samples needed to validate the biomarker observations regarding GBMs
and to be in a position to extend the discovery process to ovarian and stomach
cancers. At this point, the company will consider seeking another CRADA to
extend the scope of its research or establishing an independent laboratory.
The
timing of this expansion will depend on raising additional capital of
approximately $2.0 million by sale of additional shares of stock. A chief
executive officer would then be recruited to manage the business affairs of
the
company. It is anticipated that this may require less than full time effort
for
the second year with a need developing for a full time CEO and at least a part
time financial officer in the third year of operation.
Board
of Directors
Philip F.
Palmedo
Dr.
Philip F. Palmedo has had a diversified career as a physicist, entrepreneur,
corporate manager and writer. Dr. Palmedo received his undergraduate degree
from
Williams College and M.S. and Ph.D. degrees from MIT. He carried out
experimental nuclear reactor physics research at MIT, Oak Ridge National
Laboratory, the French Atomic Energy Commission Laboratory at Saclay and
Brookhaven National Laboratory (BNL). At BNL in 1972 he initiated and was the
first head of the Energy Policy Analysis Group. In 1974 he served with the
Energy Policy Office of the White House and in the following year initiated
the
BNL Developing Country Energy Program.
-3-
In
1979
Dr. Palmedo founded the International Resources Group, an international
professional services firm in energy, environment and natural resources. He
served as Chairman and CEO until 1988 and since that time remains as Chairman
of
the company. In 1985 the company was recognized by Inc.
Magazine
as one
of the 500 fastest growing private companies in the U.S.
In
1988
Dr. Palmedo joined in the formation of Kepler Financial Management, Ltd., a
quantitative financial research and trading company. Dr. Palmedo held the
position of President and Managing Director until the end of 1991 when
Renaissance Technologies Corporation acquired the company. In 2005 he started
a
new hedge fund, Kepler Asset Management, and is a Managing Director of the
firm.
Dr.
Palmedo was the designer and, in 1992, became the first president of the Long
Island Research Institute. LIRI was formed by Brookhaven National Laboratory,
Cold Spring Harbor Laboratory, and Stony Brook University to facilitate the
commercialization of technologies developed in their research and development
programs. LIRI guided fledgling companies and started several new high tech
entities. In order to provide “zero-stage” financing, LIRI created the Long
Island Venture Fund, which evolved into the $250 million Topspin Fund.
Dr.
Palmedo served on the boards of Asset Management Advisors and the Teton Trust
Company and is currently a member of the Board of Directors of EHR Investments
and the Gyrodyne Corporation of America. Dr. Palmedo also served on the Board
of
Trustees of Williams College and of the Stony Brook (University) Foundation
and
chaired the Foundation’s Investment Committee. He is the founding Chairman of
the non-profit Cultural Preservation Fund.
Dr.
Palmedo has served as a consultant and advisor to numerous corporations and
national and international agencies in science, technology and environmental
policy including the MacArthur Foundation, the U. S. National Academy of
Sciences, International Atomic Energy Agency, UNIDO, Organization of American
States, the Governments of Sweden, Denmark, Dominican Republic, Indonesia,
Somalia, Sudan, Egypt and Peru. He is the author of many publications in nuclear
reactor physics, energy and environment, and technology and economic
development. Dr. Palmedo has two sons and lives in St. James, Long Island,
N.Y.
with his wife, Elisabeth.
Scientific
Advisory Committee
Arndt
Hartmann, MD
Dr.
Hartmann is Professor of Pathology, Institute of Pathology, University of
Regensburg, Germany. He was trained in Internal Medicine at the University
of
Jena, Germany, and in molecular genetics of cancer at Mayo Clinic, Rochester,
MN. He was subsequently trained in pathology at the University of Regensburg
and
the University of Basel, Switzerland. His research is focused on methods
development in molecular pathology. He has specific expertise in genetic
alterations in cancers of the bladder, prostate, kidney and breast.
-4-
Ferdinand
Hofstadter, MD
Dr.
Hofstadter is Professor and Director of the Institute of Pathology, University
of Regensburg Medical School, Germany. He is Research Dean of the University
of
Regensburg-Medical Faculty, Chairman of the Managing Board of the Association
of
German Tumor Centers, Chairman of the German Society for Pathology, a member
of
the editorial boards of Virchow’s Archives and the Journal of Pathology, and a
referee for Deutsche Forschungsgesellschaft, the Dr. Mildred Scheel-Stiftung,
EU, and the European Research Framework Program.
Stefan
Madajewicz, MD, PhD
Dr.
Madajewicz is Professor of Medicine. For the past 15 years, he has been Director
of Cancer Clinical Trials and for the past 10 years, Chief, Neoplastic Diseases
at SUNY-Stony Brook. Dr. Madajewicz is a Fellow, American College of Physicians
and a member of the American Society of Clinical Oncology, American Association
for Cancer Research, European Society of Medical Oncology an affiliate of the
Eastern Cooperative Oncology Group, and member of the National Surgical Adjuvant
Breast and Bowel Project. He is recognized as an outstanding cancer clinician
and for the design of clinical trials, particularly the evaluation of new drugs
in the treatment of cancers of the gastrointestinal tract and brain.
Iwao
Ojima, BS, MS, PhD
Professor
Ojima is Distinguished Professor of Chemistry and Director, Institute of
Chemical Biology and Drug Discovery, SUNY-Stony Brook. He is an internationally
recognized expert in medicinal chemistry, including anticancer agents and enzyme
inhibitors, development of efficient synthetic methods for organic synthesis
by
means of organometallic reagents, homogeneous catalysis and organometallic
chemistry, peptide and peptide mimetics, beta-lactam chemistry, and
organoflourine chemistry at the biomedical interface.
Dr.
Ojima
is a recipient of the Arthur C. Cope Scholar Award (1994) and the E. B.
Hershberg Award (for important discovery of medicinally active substances)
(2001) from the American Chemical Society; The Chemical Society of Japan Award
(for distinguished achievements) (1999); Outstanding Inventor Award from the
Research Foundation of the State University of New York (2002. He is a Fellow
of
the J.S. Guggenheim Memorial Foundation (1995-), the American Association for
the Advancement of Science (1997-), and The New York Academy of Sciences
(2000-).
Dr.
Ojima
is a member of the American Chemical Society, American Association for the
Advancement of Science, American Association for Cancer Research, American
Peptide Society, the Chemical Society of Japan, the Society of Synthetic Organic
Chemistry, Japan, New York Academy of Sciences, and Signa Xi. He has served
as a
consultant for E. I. du Pont, Eli Lilly, Air Products & Chemicals,
Mitsubishi Chem. Inc., Nippon Steel Corp., Life Science Division, Rhone-Poulenc
Rorer, ImmunoGen, Inc., Taiho Pharmaceutical Co., Milliken & Co., Aventis
Pharma, OSI Pharmaceuticals, Inc., Mitsubishi Chem. Corp.
(current).
-5-
Family
Relationships
None.
Security
Ownership of Certain Beneficial Owners and Management
The
following table sets forth the number of shares of common stock beneficially
owned as by (i) those persons or groups known to beneficially own more than
5% of the Company’s common stock prior to the closing of the Exchange,
(ii) those persons or groups who beneficially own more than 5% of The
Company’s common stock as of the closing of the Exchange, (iii) each
current director and each person that became a director upon the closing of
the
Exchange, (iv) all current directors and executive officers as a group and
(v) all directors and executive officers after the closing of the Exchange
as a group. The information is determined in accordance with Rule 13d-3
promulgated under the Securities Exchange Act of 1934, as amended. Except as
indicated below, the stockholders listed possess sole voting and investment
power with respect to their shares.
Before
Closing
of
Exchange
(1)
|
After
Closing
of
Exchange(2)
|
||||||||||||
Name
and Address of Beneficial Owner
|
Amount
and Nature of Beneficial Ownership
|
Percent
of Class
|
Amount
and Nature of Beneficial Ownership
|
Percent
of Class
|
|||||||||
Pre-Exchange
Officers, Directors and 5% stockholders
|
|||||||||||||
Debbie
Schwartzberg
800
5th
Avenue
New
York, New York
|
1,155,000
|
28.8
|
%
|
1,154,845
|
4.2
|
%
|
|||||||
Richard
Rappaport
1900
Avenue of the Stars, Suite 310
Los
Angeles, California 90067
|
1,155,000
|
28.8
|
%
|
1,154,845
|
4.2
|
%
|
|||||||
TMC
Ulster Holdings, Inc.
1900
Avenue of the Stars, Suite 310
Los
Angeles, California 90067
|
1,005,556
|
25.1
|
%
|
1,005,556
|
3.6
|
%
|
|||||||
Tom
Poletti
1900
Avenue of the Stars, Suite 310
Los
Angeles, California 90067
|
270,000
|
6.7
|
%
|
269,973
|
*
|
||||||||
Anthony
C. Pintsopoulos
1900
Avenue of the Stars, Suite 310
Los
Angeles, California 90067
|
270,000
|
6.7
|
%
|
269,973
|
*
|
||||||||
Glenn
Krinsky
1900
Avenue of the Stars, Suite 310
Los
Angeles, California 90067
|
150,000
|
3.7
|
%
|
149,985
|
*
|
||||||||
Post-Exchange
Officers, Directors and 5% stockholders
|
|
||||||||||||
Dr.John
S. Kovach
248
Route 25A, No. 2
East
Setauket, New York 11733
|
|
|
19,021,786
|
69.1
|
%
|
||||||||
Dr.
Philip F. Palmedo
248
Route 25A, No. 2
East
Setauket, New York 11733
|
|
|
256,666
|
(3)
|
*
|
||||||||
All
Officers and directors as a group (two persons prior to and following
the
consummation of the Exchange)
|
1,425,000
|
35.5
|
%
|
19,278,452
|
70.0
|
%
|
(1)
|
Based on 4,005,556 shares outstanding on June 29, 2006. |
(2)
|
Based
on 27,531,846 shares of the Company’s common stock outstanding projected
to be outstanding following the closing of the Exchange and the completion
of the maximum amount of the Private Placement ($1,500,000).
|
(3)
|
Consists
of shares issuable pursuant to the exercise of immediately exercisable
options to be granted to Dr. Palmedo as of the closing of the
Exchange.
|
-6-
BUSINESS
OF THE COMPANY
Immediately
prior to the completion of the Exchange, the Company did not conduct any
business operations and had minimal assets and liabilities.
Explanatory
Note
Unless
otherwise indicated or the context otherwise requires, all references below
in
this Report on Form 8-K to “we,” “us” and the “Company” are to SRKP 7, Inc., a
Delaware corporation and its subsidiary, Lixte Biotechnology, Inc. References
to
“Lixte” are to Lixte Biotechnology, Inc., a Delaware corporation.
Cautionary
Notice Regarding Forward Looking Statements
The
Company desires to take advantage of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995. This Report on Form 8-K contains
a
number of forward-looking statements that reflect management’s current views and
expectations with respect to its business, strategies, products future results
and events and financial performance. All statements made in this Report other
than statements of historical fact, including statements that address operating
performance, events or developments that management expects or anticipates
will
or may occur in the future, including statements related to distributor
channels, volume growth, revenues, profitability, new products, adequacy of
funds from operations, statements expressing general optimism about future
operating results and non-historical information, are forward looking
statements. In particular, the words “believe,” “expect,” “intend,” “
anticipate,” “estimate,” “may,” “will,” variations of such words, and similar
expressions identify forward-looking statements, but are not the exclusive
means
of identifying such statements and their absence does not mean that the
statement is not forward-looking. These forward-looking statements are subject
to certain risks and uncertainties, including those discussed below. Actual
results, performance or achievements could differ materially from historical
results as well as those expressed in, anticipated or implied by these
forward-looking statements. Lixte does not undertake any obligation to revise
these forward-looking statements to reflect any future events or circumstances.
-7-
Readers
should not place undue reliance on these forward-looking statements, which
are
based on management’s current expectations and projections about future events,
are not guarantees of future performance, are subject to risks, uncertainties
and assumptions (including those described below) and apply only as of the
date
of this Report. Actual results, performance or achievements could differ
materially from the results expressed in, or implied by, these forward-looking
statements. Factors that could cause or contribute to such differences include,
but are not limited to, those discussed below in “Risk Factors” as well as those
discussed elsewhere in this Report, and the risks to be discussed in the next
Annual Report on Form 10-KSB and in the press releases and other communications
to stockholders issued by Lixte from time to time which attempt to advise
interested parties of the risks and factors that may affect its business. Lixte
undertakes no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or
otherwise.
Glossary
of Terms as Used in This Report
Assay
An
assay
is a
method to determine the presence, absence, or the amount of a particular
substance in a sample. Assays
of body
fluids such as blood and urine can be used to detect specific products
(biomarkers)
that
indicate the presence of a specific type of cancer.
Biomarker
A
biomarker
is a
component of a cell that is uniquely or strongly associated with a particular
feature of that cell. The detection of the biomarker in body fluid by an
assay
indicates that a particular cell is very likely to be present in the body.
In
this memorandum, “biomarkers”
refer
primarily to proteins
that are
uniquely produced by specific types of cancer cells or that are produced in
excess by the cancer cells compared to non—cancer cells of the same tissue or
organ.
Cancer
A
disease
characterized by loss or enhancement of one or more mechanisms that regulate
the
growth of cells of a specific tissue. Loss of these control mechanisms or gain
of abnormal mechanisms in a single cell that put cell
growth
into
overdrive allows that cell to grow, invade local tissue, and to spread to other
regions of the body. This spreading of altered cells to distant sites is the
process called metastasis.
-8-
Cell
Growth
Cell
growth
is the
ability of an individual cell to reproduce by dividing into two cells. During
normal development and subsequently during the life of the adult, this process
is highly controlled. Loss of this control is the distinguishing feature of
cancer cells. Although all cancer cells gain the capacity for uncontrolled
growth, in most instances they retain many of the highly specialized features
(and associated specific molecular components) that were characteristic of
the
normal tissue before loss of growth control. For example, breast cancer cells
and brain cancer cells have lost control of growth and may be unrecognizable
by
their appearance under the microscope but
identifiable by the presence of biomarkers specific to breast or brain
cells.
CRADA
A
CRADA
(Cooperative Research and Development Agreement) is a formal contractual
mechanism by which a variety of federal government agencies may agree to work
collaboratively with a non-governmental entity to study and advance a particular
idea, observation, or process under a defined plan of work.
Gene
A
gene
is a
unit of information that specifies the structure of one or more gene
products.
Collectively, genes determine the precise composition of all molecules needed
for maintenance of the functions of life: reproduction, development,
organization, growth and metabolism. Genes
are
often referred to as units of heredity because they pass on the information
necessary for all characteristics of an individual. For mammals like ourselves,
one set of genes is received from each parent.
Gene
Products
The
products of genes are the thousands of different chemical structures, called
molecules, needed for development of all cells. Most gene products are proteins.
Most proteins are enzymes, molecules that can carry out work such as digesting
and utilizing food for energy, signaling the cell to produce other gene products
in response to changing conditions in the body, and controlling cell
growth.
When
proteins controlling cell
growth
are
altered, as occurs in all cancers, they become prime candidates for biomarkers
that
reveal the presence of cancer.
Glioblastoma
Multiforme (GBM)
GBM
is the
most common and most aggressive type of primary human brain cancer. The name
derives from the fact that the brain cell that loses growth control and becomes
a brain cancer cell is a glial cell (glioblastoma); as the altered glial cells
grow without restraint, they take on many different shapes (multiforme). Recent
studies suggest, however, that GBMs may arise from primitive brain stem cells
rather than from glial cells. GBM
is the
initial target of Lixte Biotechnology, Inc.
-9-
Metastasis
Metastasis
is the
process by which cancers acquire the ability to spread to other parts of the
body by entry and dissemination through the blood and/or lymph systems. The
devastating aspect of metastasis is the ability of the cancer cells to grow
in a
new environment (new tissue) Examples are the metastasis of breast cancer cells
to the brain and liver and prostate cancer cells to bone.
Cure
of
cancers is much more difficult to achieve after metastasis
has
occurred. A major goal of our biomarker research is to develop assays
for
detection of cancers before they have invaded extensively or metastasized,
allowing complete removal by surgery.
Mutation
A
mutation
is a
change in one or more building blocks of a gene. Some changes can be tolerated
without altering the integrity (function) of the product of the gene but other
changes can result in cancer.
For
the
purposes of the cancer projects described in this memorandum, it is important
to
distinguish between inherited mutations (inborn mutations) and acquired
(environmentally caused) mutations.
Some
inborn mutations predispose an individual to development of one or more kinds
of
cancer. Because these mutations are inherited, they are present in every cell
in
the body. Such mutations are responsible for the higher frequency of certain
cancers in particular families and ethnic groups. Examples are the breast cancer
predisposing genes known as BRCA I and BRCA II.
Research
on biomarkers,
however, is directed at finding the gene products (proteins) of acquired
mutations. Acquired mutations that change a single cell to a cancer cell are
present ONLY in that cell and cells arising from its uncontrolled cell
growth.
If the
products of the altered genes in these cancer cells are detectable in the body,
they may reveal the presence of the cancer at a stage when it is curable by
surgery.
Prognosis
Prognosis
refers
to the likely course of a disease at specific stage of development. For example,
a breast or prostate cancer that is not confined to the tissue of origin, e.g.
is also present in a lymph node when first detected, has a greater likelihood
of
recurrence, a worse prognosis, than if it were confined to the tissue of
origin.
Thus,
the
presence of lymph node metastases is an indicator of poor
prognosis.
It
is
hoped that specific biomarkers
for
cancers will be found that have prognostic value. With assays for such markers,
patients with poor prognoses could consider more aggressive treatments before
obvious spread of disease and patients with good prognoses could be spared
unnecessary treatment.
-10-
Proteins
Proteins
are
molecules that have many functions important to the nature and behavior of
the
cell. Many proteins are enzymes that regulate and integrate a myriad of
biochemical processes essential to life.
Certain
enzymes are critical to an integrated system of cellular signaling that
regulates cell behavior in response to a constantly changing environment and
maintains the specialized nature of different types of cells. It is likely
that
some biomarkers
of
cancers have perverted signaling functions that perpetuate the abnormal behavior
of the cancer.
Thus,
discovery of biomarkers of known function that are unique or overly abundant
in
specific types of cancers may provide clues as to the biochemical
vulnerabilities of these cancers, weaknesses that can be attacked selectively
by
specific classes of drugs.
The
Company
Lixte
was
created to capitalize on opportunities for the company to develop 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.
Research
Objectives
In
the
first year of operation, Lixte will concentrate on exploiting the biomarker
pathway associated with the growth of GBMs to identify drugs with potential
selective activity against this type of tumor. In the first year, Lixte will
also collect the clinical samples needed for the identification of biomarkers
for ovarian and stomach cancer. Subsequently, Lixte will include cancers of
the
breast, prostate, colon, bladder, and kidney. For each of these diseases, a
biomarker that would enable identification of the presence of cancer at a stage
curable by surgery would save thousands of lives annually. Biomarkers specific
to these diseases may also provide clues as to processes (biological pathways)
that may be important to the growth of the cancer and therefore be vulnerable
to
drug treatments targeted to the biomarker pathway.
Lixte
will seek to identify new treatments for the most common and most aggressive
type of primary brain cancer, glioblastoma multiforme (“GBM”) under a
Cooperative Research and Development Agreement (“CRADA”) with the National
Institute of Neurological Diseases and Stroke (“NINDS”) of the National
Institutes of Health (“NIH”). A second goal of the CRADA is to determine whether
expression of a component of the biomarker pathway correlates with prognosis
in
glioma patients.
The
collaborating NIH laboratory is directed by Dr. Zhengping Zhuang, who is an
internationally recognized molecular pathologist. He has four issued and two
pending patents related to molecular pathology of human cancers. Dr. Zhuang
and
colleagues at NIH recently discovered a biomarker that Lixte believes can be
used as a tool for identifying drugs that affect the growth of GBM cells. Under
the CRADA, Lixte will support studies in Dr. Zhuang’s laboratory with $200,000
annually for two years for two research assistants expected to be at the
post-doctoral level and supplies. The selection of the research personnel will
be made by Dr. Zhuang.
-11-
Intellectual
Property
Lixte
sponsored the development and submission of a provisional patent application
filed February 6, 2006 (the “Provisional Patent Application”) naming as
co-inventors Dr. Zhuang, several other NIH investigators, and Dr. Kovach. When
the final patent application is filed in early 2007, the named inventors will
assign their rights in the inventions to their employers, meaning that any
patent (or patents) arising out of the application will be jointly owned by
the
U.S. Government and Lixte. Lixte is currently in the negotiations with the
NIH
to obtain the exclusive commercial rights to the inventions covered by the
Provisional Patent Application. Lixte expects to file further patent
applications relating to the categories of products described below. Patent
applications arising out of research pursuant to the CRADA are likely to be
jointly
owned by
Lixte and the U.S. Government. In such cases of joint ownership, Lixte will
likely seek to obtain the exclusive commercial rights to those
inventions.
Access
to Clinical Materials
To
detect
and to assess the clinical relevance of biomarkers, Lixte needs access to human
tissue, blood and perhaps other body fluids of patients with and without the
specific types of cancer under study. Lixte is negotiating an agreement with
the
Institute of Pathology at the University of Regensburg in Germany to receive
a
supply of high quality, accurately annotated tissue and blood samples.. This
arrangement provides Lixte with appropriate clinical samples for which
permission has been obtained to study any molecular feature of the tissue for
commercial purposes. This is an absolute requirement for success of a for-profit
company in this field.
The
collection, selection, histological characterization, and processing of tissue
samples and collection of blood samples will be managed by Arndt Hartmann,
M.D.,
a Professor in the Institute of Pathology at the University of Regensburg.
Dr.
Hartmann is an expert clinical and molecular pathologist and is
keenly
interested in the project. His research is focused on the molecular genetics
of
breast, bladder, prostate and kidney cancer. He was a research fellow for three
years in Dr. Kovach’s laboratory at the Mayo Clinic in Rochester before
completing his residency in pathology and joining the faculty at Regensburg
University. Dr. Hartmann is a member of the Scientific Advisory Committee
of Lixte.
Products
Lixte’s
products will derive directly from its intellectual property consisting of
its
Provisional Patent Application and
other
patents it anticipates will arise from its research activities. Those patents
are expected to cover biomarkers uniquely associated with specific types of
cancer that may provide the bases for assays suitable for cancer detection
and
patents on methods to identify drugs that inhibit growth of specific tumor
types
and combinations of drugs as potential therapeutic agents for the treatment
of
specific cancers.
The
Company believes that there are four main markets for
potential products which may be developed by Lixte.
1.
|
Improved
Cancer Treatments. Improved
chemotherapy regimens for cancers not curable by surgery or
radiation;
|
-12-
2.
|
Diagnostic
Assays. Improved
assays of body fluids, primarily blood, for the diagnosis of cancers
at
stages when cure is possible through surgery and/or
radiotherapy;
|
3.
|
Estimation
of Prognosis. Improved
methods for estimation of prognosis by molecular sub-classification
of
histologically indistinguishable tumor subtypes;
and
|
4.
|
Assessment
of Therapeutic Effectiveness. Improved
methods to assess therapeutic effectiveness by monitoring with biomarker
assays persistence or reappearance of cancer during and after treatment
and during drug development.
|
Each
market is discussed below.
1. Improved
Cancer Treatments
Lixte
will seek to develop improved therapeutic regimens when biomarkers provide
insight into pathways vulnerable to chemical and/or immunological attack. Some
tumor biomarkers have specific (enzymatic) functions and are “drugable,” that
is, their function can be altered pharmacologically. For example, the
identification of the biomarker specific to regulation of GBMs has led to
development of an assay for screening compounds for anti-GBM
activity.
2.
Diagnostic Assays
Lixte
intends to work under the CRADA with NINDS to assess the clinical potential
of
the new biomarker for GBM. Using the approach developed by Dr. Zhuang to
identify markers for GBM and for other rare tumors, Lixte also intends to
initiate searches for biomarkers in other common cancers for which there is
no
highly
specific and sensitive blood test for early detection. The focus for the first
two years, in addition to GBMs, will be ovarian and gastric cancer. For these
diseases, a reliable blood test for their detection at an early surgically
curable stage would save many lives. If Lixte resources increase as anticipated,
research will likely be extended to the identification of biomarkers for stomach
and ovarian cancer and subsequently to biomarkers for breast, prostate, colon,
bladder, and kidney cancers.
2. Estimation
of Prognosis
There
is
a wide spectrum of aggressiveness and responsiveness to drug treatments for
many
cancers that are clinically indistinguishable with present methods of
classification. Judgment of the aggressiveness of most
cancers
is currently based on their morphologic appearance under the microscope and,
for
some tumors, on a few molecular features such as hormone receptors associated
with breast cancers. There are few biomarkers sufficiently reliable to predict
the prognosis of a given cancer patient so that treatment intensity can be
adjusted with confidence toward less or more toxic regimens.
-13-
3. Assessment
of Therapeutic Effectiveness
The
Company believes that specific and sensitive biomarkers for any human cancer
are
in great demand by pharmaceutical companies and by the National Cancer Institute
as aids to drug development and to the development of targeted drug treatment.
In addition, the Company believes that biomarkers that reflect disease
progression and regression during initial clinical evaluation of new therapeutic
agents could greatly reduce the cost of new drug development. To assess the
effectiveness of a specific treatment, it would be less expensive and more
efficient to monitor the appearance and disappearance of a biomarker in the
blood than to monitor the course of disease by radiological imaging.
The
Market
The
Company believes that a sensitive, specific, reasonably priced assay for the
detection of any common human cancer at an early stage
could
save thousands of lives annually, reduce health care costs, and generate
significant income.
Brain
Cancer
The
most
malignant type of brain cancer, GBM, although less common than stomach, breast
and prostate cancers, is almost invariably fatal. Typically, survival after
surgery and radiation is only 12 to 18 months. A biomarker reflecting disease
progression and, most importantly, providing a method to develop more specific
and effective treatments of GBM would be an important discovery.
Stomach
Cancer
The
Company believes that stomach cancer (gastric cancer) is a target for biomarker
identification because of its high prevalence in certain of the world’s
population, particularly in Asia. Since gastric cancer is uncommon in the West,
development of new diagnostics and treatments is not a priority for many
pharmaceutical and diagnostic companies, providing a special opportunity for
Lixte.
Current
screening for gastric cancer entails passing a tube into the stomach
(gastroscopy) and sampling of suspicious areas.
The
invasive nature and cost of gastroscopy with sedation limits systematic
screening of large numbers of individuals at risk. The Company believes that
a
blood test for the early detection of stomach cancer could save many lives
and
significantly reduce health care costs in countries with a high prevalence
of
the disease.
Ovarian
Cancer
Although
ovarian cancer is much less common than breast cancer, cancer of the ovary
is
responsible for the death of almost half as many women who die from breast
cancer. Less than 50% of women are cured of ovarian
cancer
because the disease is almost always in an advanced stage before it produces
symptoms. Yet, if ovarian cancer is found early, the cure rate is 90% or better.
A blood test for screening women at risk (all women who are 50 or older) is
urgently needed.
-14-
Marketing
Plan
Once
a
biomarker has been identified, depending on the projected cost for evaluation,
Lixte expects to either conduct the initial assessment
using
its resources or seek partners in industry for clinical development. If we
have
the resources, we prefer to generate evidence of clinical value on our own
to
maximize financial value of the product.
If
we do
not have the resources needed to develop the clinical potential of a given
biomarker ourselves, we intend to try to find partners in large diagnostic
and/or pharmaceutical companies. These companies are increasingly dependent
upon
new biomarkers discovered by academic groups and small biotechnology companies
to maintain a pipeline of promising drugs and new diagnostic tools.
We
are
confident that the molecular approaches that led to the discovery of the
biomarker for GBMs (and the subject of the Provisional Patent Application)
could
lead to the discovery of equally promising new biomarkers
for
other cancers. If discovered and developed, the challenge will be to decide
which products to license early and which to carry into clinical evaluation
without a pharmaceutical company partner.
Research
and Development
The
primary objective of Lixte is to develop sensitive and specific assays for
identification of potential therapeutic targets and for the early detection
for
several common cancers. Most cancers produce abnormal proteins or abnormal
amounts
of normal proteins. How many of these potential biomarkers are present at
detectable concentrations in the blood is not known.
There
are
four steps in our biomarker
detection and validation process:
1. Tissue
Acquisition
The
acquisition of well-characterized cancer tissue and blood samples from cancer
patients and control individuals is the most critical step to success. We
believe that Lixte should have access to the clinical samples needed for its
program from the Institute of Pathology at University of Regensburg in Germany.
We expect that the samples we will obtain will be or have been collected under
the regulatory requirements of the European
Union
and of the Office of Protection of Research Subjects in the United States.
Those
regulations require that each patient be fully informed about the process,
the
use of the samples, and any attendant risks. Though there is a negligible
medical risk related to the collection of the samples for Lixte’s purposes, the
consent form points out that the tissue is not needed for clinical purposes
and
that the research done will not affect the patient’s care in any way.
The
consent specifies further that the samples will be used to develop diagnostic
tests and/or treatments for cancer that may have commercial value and that
the
participants will not be entitled to any of the financial benefits from the
product’s development. All samples are coded and the privacy of all participants
is
assured because personal identifiers are never shared with Lixte by the
University of Regensburg. Obtaining consent is the responsibility of the
collaborating institution, but all consent processes and forms will be jointly
approved by the collaborating institution and by Lixte.
-15-
2. Tissue
Processing
For
maximum efficiency in detecting biomarkers, cancer cells must be isolated from
a
complex matrix of normal cells and other structural elements of tissue in which
the cancer has arisen under conditions that do not alter potential biomarkers.
The procedures used minimize destruction and alteration of cell components.
Once
processed, preparations can be transported without compromising their integrity.
3. Detection
and Identification of Biomarkers
The
search for molecular elements with features unique to a specific cancer type
is
accomplished using highly reproducible physical techniques. These techniques
are
not proprietary but involve technologies used in sequences that are not obvious.
The most prominent biomarkers for each tumor type are identified by mass
spectrometric sequencing. We will select for patenting and clinical evaluation
biomarkers present at high frequency in all cancers of the same type.
4. Development
of Assays for Biomarkers in the Blood
Whether
to develop an assay for selected biomarkers is an important decision point.
Assay development is an expensive component of the discovery process but also
an
essential step in establishing commercial value.
For
each cancer type, we expect to screen sera of affected and unaffected persons
for the five most promising biomarkers of known sequence for which patent
protection seems achievable. Maximum value of the product for diagnostics is
achieved by demonstrating the presence of specific biomarkers in the serum
of
patients harboring the cancer of interest and their absence in the sera of
patients without the cancer.
Biomarkers
not useful for diagnostic assays may still have significant value as markers
of
prognosis and/or as drug targets. For example, although it is not yet clear
whether the new biomarker discovered by Dr. Zhuang will serve as a useful
diagnostic assay for GBMs, that biomarker is nevertheless valuable because
it
was demonstrated to provide a tool for identification of new drug combinations
active against GBMs in vitro.
Using
stringent criteria for biomarker selection, analysis of small numbers of a
given
type of cancer is sufficient for detection of relevant biomarkers. If potential
biomarkers for early diagnosis are discovered
for
several types of cancer, such as the one already identified for GBMs, we will
prioritize their development in the following order: stomach, ovary, prostate,
colon, bladder, and kidney. If a particularly compelling opportunity arises,
we
have the flexibility to quickly direct resources to maximize chances of
developing a clinically useful product.
Employees
As
of
June 30, 2006, Lixte had no full-time employees. Dr. Kovach is Chair, Department
of Preventive Medicine, SUNY, Stony Brook. He received approval from the School
of Medicine, Stony Brook University and approval from the New York State Ethics
Commission to operate and hold greater than 5% of outstanding shares of the
Company.
-16-
Our
investment commitments in the research efforts pursuant to the CRADA fund two
technical assistants who will work under the supervision of Dr. Zhuang on the
aims of the CRADA. Dr. Kovach will devote 0.2 person/years of his efforts per
year to research planning and design and monitoring progress of the research
under the CRADA. Dr. Kovach’s contributions will be made outside of his academic
responsibilities.
Contacts
The
business address is:
Lixte
Biotechnology, Inc.
248
Route
25A #2
East
Setauket, NY 11733
Legal
Proceedings
We
are
not a party to any legal proceedings.
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND
RESULTS OF OPERATIONS
The
following discussion of our financial condition and results of operations should
be read in conjunction with our financial statements and related notes, and
the
other financial information included in this Memorandum.
Forward-Looking
Statements
The
forward-looking comments contained in this discussion involve risks and
uncertainties. Our actual results may differ materially from those discussed
here due to factors such as, among others, limited operating history, difficulty
in developing, exploiting and protecting proprietary technologies, intense
competition and substantial regulation in the healthcare industry. Additional
factors that could cause or contribute to such differences can be found in
the
following discussion, as well as in the section entitled “Risks
Factors.”
Recent
Events
Completion
of Reverse Merger
Concurrently
with the initial closing of the Private Placement, SRKP 7, Inc. acquired all
of
the capital stock of Lixte pursuant to a Share Exchange Agreement with the
shareholder of Lixte. In connection with the Reverse Merger, the Company issued
to the shareholder of Lixte 19,021,786 shares of the Company’s Common Stock. As
a result, Lixte became a wholly owned subsidiary of SRKP 7, Inc. As Lixte will
be treated as the “accounting acquirer” all of the financial information except
certain share information refers to Lixte.
-17-
Accordingly,
from an historical perspective, Lixte was deemed to have been the acquirer
in
the Reverse Merger and Lixte is deemed the survivor of the reorganization.
Accordingly, the financial statements presented reflect the historical results
of Lixte prior to the Reverse Merger and do not include the historical financial
results of SRKP 7, Inc. The equity of SRKP 7, Inc. survives the reorganization.
All costs associated with the Reverse Merger were expensed as incurred.
Information with respect to shares is based on a forward split of 1.111 to
1.
Overview
Lixte
was
created to capitalize on opportunities for the company 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.
Lixte
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 would 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.
Lixte’s
initial focus is on developing new treatments for the most common and most
aggressive type of primary brain cancer, glioblastoma multiforme (“GBM”). Lixte
entered into a Cooperative Research and Development Agreement (“CRADA”) with the
National Institute of Neurological Diseases and Stroke (“NINDS”) of the National
Institutes of Health (“NIH”) to identify and evaluate drugs that target a
specific biochemical pathway for GBM cell differentiation. The CRADA also covers
research to determine whether expression of a component of this pathway
correlates with prognosis in glioma patients.
The
lead
scientist at NINDS collaborating with Lixte under the CRADA is Dr. Zhengping
Zhuang. Dr. Zhuang is internationally recognized for his research in molecular
pathology. Dr. Zhuang has four issued and two pending patents related to
molecular pathology of human cancers. He has recently discovered a biomarker
of
relevance to the growth of GBMs that Lixte believes can be used as a tool for
identifying drugs that affect the growth of GBM cells. Under the CRADA, Lixte
will support two persons at NIH to work under the direction of Dr. Zhuang.
The
goal is to identify drugs that inhibit GBM cell growth and to determine if
the
identified biomarker may be useful for estimation of prognosis. Lixte’s annual
contribution to the collaborative research done by Lixte and NIH is $200,000
annually for two years for two research assistants expected to be at the
post-doctoral level and supplies.
Lixte
sponsored the development and submission of a provisional patent application
filed February 6, 2006 (the “Provisional Patent Application”) naming as
co-inventors Dr. Zhuang, several other NIH investigators, and Dr. Kovach. When
the final patent application is filed in early 2007, the named inventors will
assign their rights in the inventions to their employers, meaning that any
patent (or patents) arising out of the application will be jointly owned by
the
U.S. Government and Lixte. Lixte is currently in the negotiations with the
NIH
to obtain the exclusive commercial rights to the inventions covered by the
Provisional Patent Application. As its research progresses, Lixte expects to
file further patent applications relating to the categories of products
described below. Patent applications arising out of research pursuant to the
CRADA are likely to be jointly owned by Lixte and the U.S. Government. In such
cases of joint ownership, Lixte will likely seek to obtain the exclusive
commercial rights to those inventions.
-18-
Lixte’s
products will derive directly from its intellectual property consisting of
its
Provisional Patent Application and other patents it anticipates it will arise
out of its research activities. Those patents are expected to cover biomarkers
uniquely associated with specific types of cancer, patents on methods to
identify drugs that inhibit growth of specific tumor types and combinations
of
drugs and potential therapeutic agents for the treatment of specific cancers.
The
Company faces several potential challenges in its drive for commercial success,
including raising sufficient capital to fund its business plan, achieving
commercially applicable results of its research program, continued access to
tissue and blood samples from cancer patients, competition from 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.
Liquidity
and Capital Resources
Because
Lixte is currently engaged in research at a very early stage, significant time
may be required
to
develop any product or intellectual property capable of generating revenues.
As
such, Lixte’s business is unlikely to generate any revenue in the next several
years and may never do so. Even if Lixte is able to generate revenues in the
future through licensing its technologies or through product sales, there is
no
assurance that such revenues will exceed its expenses.
If
the
maximum Private Placement ($1,500,000) is achieved, we believe the net proceeds
of the Private Placement will be sufficient to fund planned operations for
the
next twelve months. These funds will not be sufficient to fully develop and
commercialize any products that may arise from our research. We will also need
to raise additional funds in order to satisfy our future liquidity requirements.
Most immediately, in addition to the net proceeds from the Private Placement,
we
expect to require up to $2 million (plus the difference, if any, between
$1,290,000, the net proceeds from the maximum Private Placement and the net
amount actually received from the Private Placement). However, as of June 30,
2006, the Company has only raised $657,299 in gross proceeds. Additionally,
the
amount and timing of future cash requirements will depend on market acceptance
of our products, if any, and the resources we devote to developing and
supporting our products. We will need to fund these cash requirements from
either one or a combination of additional financings, mergers or acquisitions,
or via the sale or license of certain of our assets.
Current
market conditions present uncertainty as to
our
ability to secure additional funds, as well as our ability
to reach
profitability. There can be no assurances that
we
will be able to secure additional financing, or obtain favorable terms on such
financing if it is available,
or as to
our ability to achieve positive cash flow from operations. Continued negative
cash flows and lack of liquidity
create significant uncertainty about our ability to fully implement our
operating plan and we may have
to
reduce the scope of our planned operations. If cash and cash equivalents are
insufficient to satisfy our liquidity requirements, we would be required to
scale back or discontinue our product development program, or obtain funds
if
available through strategic alliances that may require us to relinquish rights
to certain of our technologies or discontinue our operations.
-19-
Off-Balance
Sheet Arrangements
As
of
March 31, 2006, we had no off-balance sheet arrangements.
EXECUTIVE
COMPENSATION
For
the
current fiscal year, Dr. Kovach does not anticipate receiving any
compensation from the Company in view of the Company’s early stage status. He
will be reimbursed for any out-of-pocket expenses. Any future compensation
arrangements will be subject to the approval of the board of
directors.
Option
Grants in 2005
None.
Aggregated
Option Exercises in 2005 and Option Values at December 31,
2005
None.
Option
Plans
Members
of the Board of Directors
Each
outside member of the Board will receive options to purchase 200,000 shares
of
common stock at the initial private placement price of $0.333/ share with one
third of the options (66,666 shares) vesting immediately upon joining the board
and one third vesting annually for two years on the anniversary of that date.
Board
member, Phillip Palmedo also will receive additional options to purchase 190,000
shares of common stock at $0.333 per share for services rendered in developing
the business plan for Lixte.
Members
of the Scientific Advisory Committee
Each
member of the Scientific Advisory Committee (SAC) other than Drs. Hartmann
and
Hofstadter will receive options to purchase 50,000 shares of common stock at
the
initial private placement price of $0.333/share with one half of the options
(25,000 shares) vesting on the first anniversary of joining the SAC and one
half
vesting on the second anniversary.
-20-
Indemnification
of Directors and Executive Officers and Limitation of
Liability
Under
Section 145 of the General Corporation Law of the State of Delaware, we can
indemnify our directors and officers against liabilities they may incur in
such
capacities, including liabilities under the Securities Act of 1933, as amended
(the “Securities Act”). The Company’s Certificate of Incorporation and Bylaws
provide for indemnification. The provisions in our certificate of incorporation,
bylaws and the Delaware statute do not eliminate the duty of care, and in
appropriate circumstances equitable remedies such as injunctive or other forms
of nonmonetary relief will remain available under Delaware law. In addition,
each director will continue to be subject to liability for breach of the
director’s duty of loyalty to us or our stockholders, for acts or omissions not
in good faith or involving intentional misconduct or knowing violations of
the
law, for actions leading to improper personal benefit to the director, and
for
payment of dividends or approval of stock repurchases or redemptions that are
unlawful under Delaware law. The provisions also do not affect a director’s
responsibilities under any other law, such as the federal securities laws or
state or federal environmental laws.
We
have
been advised that in the opinion of the Securities and Exchange Commission,
insofar as indemnification for liabilities arising under the Securities Act
may
be permitted to our directors, officers and controlling persons pursuant to
the
foregoing provisions, or otherwise, such indemnification is against public
policy as expressed in the Securities Act and is therefore unenforceable. In
the
event a claim for indemnification against such liabilities (other than our
payment of expenses incurred or paid by our director, officer or controlling
person in the successful defense of any action, suit or proceeding) is asserted
by such director, officer or controlling person in connection with the
securities being registered, we will, unless in the opinion of our counsel
the
matter has been settled by controlling precedent, submit to a court of
appropriate jurisdiction the question of whether such indemnification by us
is
against public policy as expressed in the Securities Act and will be governed
by
the final adjudication of such issue.
We
may
enter into indemnification agreements with each of our present or future
directors and officers that are, in some cases, broader than the specific
indemnification provisions permitted by Delaware law, and that may provide
additional procedural protection. The indemnification agreements may require
us,
among other things, to:
· |
indemnify
officers and directors against certain liabilities that may arise
because
of their status as officers or
directors;
|
· |
advance
expenses, as incurred, to officers and directors in connection with
a
legal proceeding, subject to limited exceptions;
or
|
· |
obtain
directors’ and officers’ insurance.
|
At
present, there is no pending litigation or proceeding involving our
director/officer or involving any of our employees in which indemnification
is
sought, nor are we aware of any threatened litigation that may result in claims
for indemnification.
-21-
RISK
FACTORS
Any
investment in our common stock involves a high degree of risk. The following
risk factors relating to Lixte should carefully considered.
RISKS
RELATED TO BUSINESS
We
are engaged in early stage research and as such may not be successful in our
efforts to develop a portfolio of commercially viable
products.
A
key
element of our strategy is to discover, develop and commercialize a portfolio
of
new drugs and diagnostic tests. We are seeking to do so through our internal
research programs. A significant portion of the research that we are conducting
involves new and unproven technologies. Research programs to identify new
disease targets and product candidates require substantial technical, financial
and human resources whether or not any candidates or technologies are ultimately
identified. Our research programs may initially show promise in identifying
potential product candidates, yet fail to yield product candidates for clinical
development for any of the following reasons:
· |
the
research methodology used may not be successful in identifying potential
product candidates;
|
· |
product
candidates for diagnostic tests may on further study be shown to
not
obtain an acceptable level of accuracy;
or
|
· |
product
candidates for drugs may on further study be shown to have harmful
side
effects or other characteristics that indicate they are unlikely
to be
effective drugs.
|
Although
we have identified one potential product candidate in the area of brain tumors,
the work needed to demonstrate its commercial viability is at a very early
stage. The follow-up research needed to demonstrate the viability of the product
is costly and time-consuming and may reveal that the product does not function
as expected or that it is otherwise not commercially viable.
If
we are
unable to discover suitable potential product candidates, develop additional
delivery technologies through internal research programs or in-license suitable
products or delivery technologies on acceptable business terms, our business
prospects will suffer.
As
the
Company has no operating history or revenue and only minimal assets, there
is a
risk that we will be unable to continue as a going concern. The Company has
had
no recent operating history nor any revenues or earnings from operations since
inception. We have no significant assets. We will, in all likelihood, sustain
operating expenses without corresponding revenues, at least until products
are
viable and marketable. This may result in our incurring a net operating loss
that will increase continuously. We cannot assure you that our products will
be
marketable.
Lixte
does not expect to obtain any revenues for several years and there is no
assurance that it will ever generate revenue or be profitable. If we do not
generate revenues and achieve profitability, we will be forced to cease or
substantially curtail our operations and you may lose your entire investment.
Because
Lixte is currently engaged in research at a very early stage, significant time
may be required
to
develop any product or intellectual property capable of generating revenues.
As
such, Lixte’s business is unlikely to generate any revenue in the next several
years and may never do so. Even if Lixte is able to generate revenues in the
future through licensing its technologies or through product sales, there is
no
assurance that such revenues will exceed its expenses. Should Lixte fail to
achieve profitability, you may lose your entire investment.
-22-
We
will need to raise additional funds in the future and these funds may not be
available on acceptable terms or at all.
If
the
maximum Private Placement is achieved, we believe the net proceeds of this
Offering will be sufficient to fund planned operations for the next twelve
months. These funds will not be sufficient to fully develop and commercialize
any products that may arise from our research. We will also need to raise
additional funds in order to satisfy our future liquidity requirements. Most
immediately in addition to the $1.5 million from the maximum amount of the
Private Placement, we expect to require up to $2 million (plus any
shortfall between $1,290,000, the net proceeds from the maximum amount of the
Private Placement and the net amount actually received from the Private
Placement) in the near term to enable us to obtain a wet lab to further advance
our research projects. Additionally, the amount and timing of future cash
requirements will depend on market acceptance of our products, if any, and
the
resources we devote to developing and supporting our products. We will need
to
fund these cash requirements from either one or a combination of additional
financings, mergers or acquisitions, or via the sale or license of certain
of
our assets.
Current
market conditions present uncertainty as to
our
ability to secure additional funds, as well as our ability
to reach
profitability. There can be no assurances that
we
will be able to secure additional financing, or obtain favorable terms on such
financing if it is available,
or as to
our ability to achieve positive cash flow from operations. Continued negative
cash flows and lack of liquidity
create significant uncertainty about our ability to fully implement our
operating plan and we may have
to
reduce the scope of our planned operations. If cash and cash equivalents are
insufficient to satisfy our liquidity requirements, we would be required to
scale back or discontinue our product development program, or obtain funds
if
available through strategic alliances that may require us to relinquish rights
to certain of our technologies or discontinue our operations.
If
we are unable to secure licenses to technologies or materials vital to our
business, or if the rights to technologies that we have licensed terminate,
our
commercialization efforts could be delayed or fail.
In
February 2006, a provisional patent application was filed covering certain
methods and classes of molecules
that we
expect to be the foundation of our product development and commercialization
efforts with respect to human brain tumors that are subject to the CRADA. Any
patents resulting from that application are likely to be jointly owned by Lixte
and the U.S. Government. We are currently in negotiations with the government
to
obtain exclusive commercialization rights with respect to those patents and
expect to execute an agreement shortly. However, should we be unable to reach
such an agreement, or should we be unable to reach such an agreement in the
future pertaining to other technologies owned by the government or third
parties, this could harm our businesses. Additionally, if those licenses
terminate and we are unable to renew them, or must renew them only on
unfavorable terms, such events could require us to cease providing products
or
services using such licensed technology and, therefore, would likely result
in
loss of revenue for our business.
-23-
Additionally,
our business depends on obtaining well-characterized blood, tissue and other
samples from patients to enable us to locate biomarkers. To that end, we intend
to collaborate with researchers at the Institute of Pathology at the University
of Regensburg in Germany, who will collect samples of brain, stomach, breast,
prostate, colon, ovarian, bladder, and kidney cancers and transmit them to
us.
We have not yet executed an agreement committing the researchers to provide
us
with
these
materials, however, though we expect to execute such an agreement shortly.
Should negotiations on such an agreement break down, however, or should future
circumstances cause our arrangement with those researchers to terminate, we
will
be forced to find other sources for those materials, and this may not be
possible or may entail a significantly greater expense.
If
we were to materially breach our present collaboration agreement or any future
license or collaboration agreements, we could lose our ability to commercialize
the related technologies, and our business could be materially and adversely
affected.
We
are
party to a research collaboration agreement and intend to enter into
intellectual property licenses
and
agreements, all of which will be integral to our business. These licenses and
agreements impose various research, development, commercialization,
sublicensing, royalty, indemnification, insurance and other obligations on
us.
If we or our collaborators fail to perform under these agreements or otherwise
breach obligations imposed by them, we could lose intellectual property rights
that are important to our business.
We
may not be successful in establishing additional strategic collaborations,
which
could adversely affect our ability to develop and commercialize
products.
In
the
future, we may seek opportunities to establish new collaborations, joint
ventures and strategic collaborations for the development and commercialization
of products we discover. We face significant competition in seeking appropriate
collaborators and the negotiation process is time-consuming
and
complex. We may not be successful in our efforts to establish additional
strategic collaborations or other alternative arrangements. Even if we are
successful in our efforts to establish a collaboration or agreement, the terms
that we establish may not be favorable to us. Finally, such strategic alliances
or other arrangements may not result in successful products and associated
revenue.
The
life sciences industry is highly competitive and subject to rapid technological
change.
The
life
sciences industry is highly competitive and subject to rapid and profound
technological change. Our present and potential competitors include major
pharmaceutical companies, as well as specialized biotechnology and life sciences
firms in the United States and in other countries. Most of these companies
have
considerably greater financial, technical and marketing resources than we do.
Additional mergers and acquisitions in the pharmaceutical and biotechnology
industries may result in even more resources being concentrated in our
competitors. Our existing or prospective competitors may develop processes
or
products that are more effective than ours or be more effective at implementing
their technologies to develop commercial products faster. Our competitors may
succeed in obtaining patent protection and/or receiving regulatory approval
for
commercializing products before us. Developments by our competitors may render
our product candidates obsolete or non-competitive.
-24-
We
also
experience competition from universities and other research institutions, and
we
are likely to compete with others in acquiring technology from those sources.
There can be no assurance that
others
will not develop technologies with significant advantages over those that we
are
seeking to develop. Any such development could harm our business.
We
may be unable to compete successfully with our
competitors.
We
face
competition from other companies seeking to identify and commercialize cancer
biomarkers. We also compete with universities and other research institutions
engaged in research in these areas. Many of our competitors have greater
technical and financial resources than we do.
Our
ability to compete successfully is based on numerous factors,
including:
· |
the
cost-effectiveness of any product we ultimately commercialize relative
to
competing products;
|
· |
the
ease of use and ready availability of any product we bring to
market;
|
· |
the
accuracy of a diagnostic test designed by us in detecting cancers,
including overcoming the propensity for “false positive” results;
and
|
· |
the
relative speed with which we are able to bring any product resulting
from
our research to market in our target
markets.
|
If
we are
unable to distinguish our products from competing products, or if competing
products reach
the
market first, we may be unable to compete successfully with current or future
competitors. This would cause our revenues to decline and affect our ability
to
achieve profitability.
We
depend on certain key scientific personnel for our success who do not work
full
time for the Company. The loss of any such personnel could adversely affect
our
business, financial condition and results of
operations.
Our
success depends on the continued availability and contributions of our President
and founder, Dr. John S. Kovach, as well as the continued availability and
contributions of Dr. Zhengping Zhuang and other collaborators at the NIH. In
particular, Dr. Kovach is 69 years old, and, because of his arrangement with
the
State University of New York, does not devote his full time to the Company.
The
loss of services of any of these persons could delay or reduce our product
development and commercialization efforts. Furthermore, recruiting and retaining
qualified scientific personnel to perform future research and development
work
will be critical to our success. The loss of members of our scientific
personnel, or our inability to attract or retain other qualified personnel
or
advisors, could significant weaken our management, harm our ability to compete
effectively and harm our business.
-25-
We
expect to rely heavily on third parties for the conduct of clinical trials
of
our product candidates. If these clinical trials are not successful, or if
we or
our collaborators are not able to obtain the necessary regulatory approvals,
we
will not be able to commercialize our product
candidates.
In
order
to obtain regulatory approval for the commercial sale of our product candidates,
we and our collaborators will be required to complete extensive preclinical
studies as well as clinical trials in humans to demonstrate to the FDA and
foreign regulatory authorities that our product candidates are safe and
effective. Dr. Kovach is experienced in the design and conduct of early clinical
cancer trials, having been the lead investigator for a National Cancer Institute
Phase I contract for ten years at the Mayo Clinic, Rochester, MN. Lixte,
however, has no experience in conducting clinical trials and expects to rely
heavily on collaborative partners and contract research organizations for their
performance and management of clinical trials of our product
candidates.
Clinical
development, including preclinical testing, is a long, expensive and uncertain
process. Accordingly, preclinical testing and clinical trials, if any, of our
product candidates under development
may not
be successful. We and our collaborators could experience delays in preclinical
or clinical trials of any of our product candidates, obtain unfavorable results
in a development program, or fail to obtain regulatory approval for the
commercialization of a product. Preclinical studies or clinical trials may
produce negative, inconsistent or inconclusive results, and we or our
collaborators may decide, or regulators may require us, to conduct additional
preclinical studies or clinical trials. The results from early clinical trials
may not be statistically significant or predictive of results that will be
obtained from expanded, advanced clinical trials.
Furthermore,
the timing and completion of clinical trials, if any, of our product candidates
depend on, among other factors, the number of patients we will be required
to
enroll in the clinical trials and the rate at which those patients are enrolled.
Any increase in the required number of patients, decrease
in
recruitment rates or difficulties retaining study participants may result in
increased costs, program delays or both.
Also,
our
products under development may not be effective in treating any of our targeted
disorders or may prove
to have
undesirable or unintended side effects, toxicities or other characteristics
that
may prevent or limit their commercial use. Institutional review boards or
regulators, including the FDA, may hold, suspend or terminate our clinical
research or the clinical trials of our product candidates for various reasons,
including non-compliance with regulatory requirements or if, in their opinion,
the participating subjects are being exposed to unacceptable health risks.
Additionally, the failure of third parties conducting or overseeing the
operation of the clinical trials to perform their contractual or regulatory
obligations in a timely fashion could delay the clinical trials. Failure of
clinical trials can occur at any stage of testing. Any of these events would
adversely affect our ability to market a product candidate.
-26-
The
development process necessary to obtain regulatory approval is lengthy, complex
and expensive. If we and our collaborative partners do not obtain necessary
regulatory approvals, then our business will be unsuccessful and the market
price of our common stock will substantially decline.
To
the
extent that we, or our collaborative partners, are able to successfully advance
a product candidate through
the
clinic, we, or such partner, will be required to obtain regulatory approval
prior to marketing and selling such product.
The
process of obtaining FDA and other required regulatory approvals is expensive.
The time required for FDA and
other
approvals is uncertain and typically takes a number of years, depending on
the
complexity and novelty of the product.
Any
regulatory approval to market a product may be subject to limitations on the
indicated uses for which we, or our collaborative partners, may market the
product. These limitations may restrict the size of the market for the product
and affect reimbursement by third-party payors. In addition,
regulatory agencies may not grant approvals on a timely basis or may revoke
or
significantly modify previously granted approvals.
We,
or
our collaborative partners, also are subject to numerous foreign regulatory
requirements governing the manufacturing and marketing of our potential future
products outside of the United States.
The
approval procedure varies among countries, additional testing may be required
in
some jurisdictions, and the time required to obtain foreign approvals often
differs from that required to obtain FDA approvals. Moreover, approval by the
FDA does not ensure approval by regulatory authorities in other countries,
and
vice versa.
As
a
result of these factors, we or our collaborators may not successfully begin
or
complete clinical trials in the
time
periods estimated, if at all. Moreover, if we or our collaborators incur costs
and delays in development programs or fail to successfully develop and
commercialize products based upon our technologies, we may not become profitable
and our stock price could decline.
Even
if our products are approved by regulatory authorities, if we fail to comply
with ongoing regulatory requirements, or if we experience unanticipated problems
with our products, these products could be subject to restrictions or withdrawal
from the market.
Any
product for which we obtain marketing approval, along with the manufacturing
processes, post-approval clinical data and promotional activities for such
product, will be subject to continual review and periodic inspections by the
FDA
and other regulatory bodies. Even if regulatory approval
of a
product is granted, the approval may be subject to limitations on the indicated
uses for which the product may be marketed or contain requirements for costly
post-marketing testing and surveillance to monitor the safety or efficacy of
the
product. Later discovery of previously unknown problems with our products,
including unanticipated adverse events or adverse events of unanticipated
severity or frequency, manufacturer or manufacturing processes, or failure
to
comply with regulatory requirements, may result in restrictions on such products
or manufacturing processes, withdrawal of the products from the market,
voluntary or mandatory recall, fines, suspension of regulatory approvals,
product seizures, injunctions or the imposition of civil or criminal
penalties.
-27-
We,
and our collaborators, are subject to governmental regulations other than those
imposed by the FDA. We, and any of our collaborators, may not be able to comply
with these regulations, which could subject us, or such collaborators, to
penalties and otherwise result in the limitation of our or such collaborators’
operations.
In
addition to regulations imposed by the FDA, we and our collaborators are subject
to regulation under various federal and state statutes and regulations such
as
the Occupational Safety and Health Act, the Environmental Protection Act, the
Toxic Substances Control Act, the Research Conservation and Recovery Act, as
well as regulations administered by the Nuclear Regulatory Commission, national
restrictions on technology transfer, and import, export and customs regulations.
From time to time, other federal agencies and congressional committees have
indicated an interest in implementing further regulation of biotechnology
applications. We are not able to predict whether any such regulations will
be
adopted
or
whether, if adopted, such regulations will apply to our business, or whether
we
or our collaborators would be able to comply with any applicable
regulations.
Failure
to obtain regulatory approval in foreign jurisdictions will prevent us from
marketing our products abroad.
We
intend
to market our products in international markets. In order to market our products
in the European Union and many other foreign jurisdictions, we must obtain
separate regulatory approvals. The approval procedure varies among countries
and
can involve additional testing, and the time required to obtain approval may
differ from that required to obtain FDA approval. The foreign regulatory
approval process may include all of the risks associated with obtaining FDA
approval. We may not obtain foreign regulatory approvals on a timely basis,
if
at all. Approval by the FDA does not ensure approval by regulatory authorities
in other countries, and approval by one foreign regulatory authority does not
ensure approval by regulatory authorities in other foreign countries or by
the
FDA. We may not be able to file for regulatory approvals and may not receive
necessary approvals to commercialize our products in any market.
We
are subject to uncertainty relating to health care reform measures and
reimbursement policies which, if not favorable to our product candidates, could
hinder or prevent our product candidates’ commercial
success.
The
continuing efforts of the government, insurance companies, managed care
organizations and other payors of health care costs to contain or reduce costs
of health care may adversely affect:
· |
our
ability to generate revenues and achieve
profitability;
|
· |
the
future revenues and profitability of our potential customers, suppliers
and collaborators; and
|
· |
the
availability of capital.
|
-28-
In
certain foreign markets, the pricing of prescription pharmaceuticals is subject
to government control. In the United States, given recent federal and state
government initiatives directed at lowering
the
total cost of health care, the U.S. Congress and state legislatures will likely
continue to focus on health care reform, the cost of prescription
pharmaceuticals and on the reform of the Medicare and Medicaid systems. For
example, legislation was enacted on December 8, 2003, which provides a new
Medicare prescription drug benefit beginning in 2006 and mandates other reforms.
While we cannot predict the full effects of the implementation of this new
legislation or whether any legislative or regulatory proposals affecting our
business will be adopted, the implementation of this legislation or announcement
or adoption of these proposals could have a material and adverse effect on
our
business, financial condition and results of operations.
Our
ability to commercialize our product candidates successfully will depend in
part
on the extent to which governmental authorities, private health insurers and
other organizations establish appropriate reimbursement
levels
for the cost of our products and related treatments. Third-party payors are
increasingly challenging the prices charged for medical products and services.
Also, the trend toward managed health care in the United States, which could
significantly influence the purchase of health care services and products,
as
well as legislative proposals to reform health care or reduce government
insurance programs, may result in lower prices for our product candidates or
exclusion of our product candidates from reimbursement programs. The cost
containment measures that health care payors and providers are instituting
and
the effect of any health care reform could materially and adversely affect
our
results of operations.
If
physicians and patients do not accept the products that we may develop, our
ability to generate product revenue in the future will be adversely
affected.
The
product candidates
that we
may develop may not gain market acceptance among physicians, healthcare payors,
patients and the medical community which will adversely affect our ability
to
generate revenue. Market acceptance of and demand for any product that we may
develop will depend on many factors, including:
· |
our
ability to provide acceptable evidence of safety and
efficacy;
|
· |
convenience
and ease of administration;
|
· |
prevalence
and severity of adverse side
effects;
|
· |
availability
of alternative treatments or diagnostic
tests;
|
· |
cost
effectiveness;
|
· |
effectiveness
of our marketing strategy and the pricing of any product that we
may
develop;
|
· |
publicity
concerning our products or competitive products;
and
|
-29-
· |
our
ability to obtain third-party coverage or
reimbursement.
|
We
face the risk of product liability claims and may not be able to obtain
insurance.
Our
business exposes us to the risk of product liability claims that is inherent
in
the testing, manufacturing, and marketing of drugs and related devices. Although
we will obtain product liability and clinical trial liability insurance when
appropriate, this insurance is subject to deductibles and coverage limitations.
We may not be able to obtain or maintain adequate protection against potential
liabilities. In addition, if any of our product candidates are approved for
marketing, we may seek additional insurance coverage. If we are unable to obtain
insurance at acceptable cost or on acceptable terms with adequate coverage
or
otherwise protect against potential product liability claims, we will be exposed
to significant liabilities, which may harm our business. These liabilities
could
prevent or interfere with our product commercialization efforts. Defending
a
suit, regardless of merit, could be costly, could divert management attention
and might result in adverse publicity or reduced acceptance of our products
in
the market.
We
cannot be certain we will be able to obtain patent protection to protect our
product candidates and technology.
We
cannot
be certain that any patent or patents will be issued based on the pending
provisional patent application we recently filed. If a third party has also
filed a patent application relating to an invention claimed by us or our
licensors, we may be required to participate in an interference proceeding
declared by the U.S. Patent and Trademark Office to determine priority of
invention, which could result in substantial uncertainties and cost for us,
even
if the eventual outcome is favorable to us. The degree of future protection
for
our proprietary rights is uncertain. For example:
· |
we
or our licensors might not have been the first to make the inventions
covered by our pending or future patent
applications;
|
· |
we
or our licensors might not have been the first to file patent applications
for these inventions;
|
· |
others
may independently develop similar or alternative technologies or
duplicate
any of our technologies;
|
· |
it
is possible that our patent applications will not result in an issued
patent or patents, or that the scope of protection granted by any
patents
arising from our patent applications will be significantly narrower
than
expected;
|
· |
any
patents under which we hold ultimate rights may not provide us with
a
basis for commercially-viable products, may not provide us with any
competitive advantages or may be challenged by third parties as not
infringed, invalid, or unenforceable under United States or foreign
laws;
|
· |
any
patent issued to us in the future or under which we hold rights may
not be
valid or enforceable; or
|
-30-
· |
we
may develop additional proprietary technologies that are not patentable
and which may not be adequately protected through trade secrets;
for
example if a competitor independently develops duplicative, similar,
or
alternative technologies.
|
If
we are not able to protect and control our unpatented trade secrets, know-how
and other technological innovation, we may suffer competitive
harm.
We
also
rely on proprietary trade secrets and unpatented know-how to protect our
research and development activities, particularly when we do not believe that
patent protection is appropriate or available. However, trade secrets are
difficult to protect. We will attempt to protect our trade secrets and
unpatented know-how by requiring our employees, consultants and advisors to
execute a confidentiality and non-use agreement. We cannot guarantee that these
agreements will provide meaningful protection, that these agreements will not
be
breached, that we will have an adequate remedy for any such breach, or that
our
trade secrets will not otherwise become known or independently developed by
a
third party. Our trade secrets, and those of our present or future collaborators
that we utilize by agreement, may become known or may be independently
discovered by others, which could adversely affect the competitive position
of
our product candidates.
We
may incur substantial costs enforcing our patents, defending against third-party
patents, invalidating third-party patents or licensing third-party intellectual
property, as a result of litigation or other proceedings relating to patent
and
other intellectual property rights.
We
may
not have rights under some patents or patent applications that may cover
technologies that we use in our research, drug targets that we select, or
product candidates that we seek to develop and commercialize. Third parties
may
own or control these patents and patent applications in the United States and
abroad. These third parties could bring claims against us or our collaborators
that would cause us to incur substantial expenses and, if successful against
us,
could cause us to pay substantial damages. Further, if a patent infringement
suit were brought against us or our collaborators, we or they could be forced
to
stop or delay research, development, manufacturing or sales of the product
or
product candidate that is the subject of the suit. We or our collaborators
therefore may choose to seek, or be required to seek, a license from the
third-party and would most likely be required to pay license fees or royalties
or both. These licenses may not be available on acceptable terms, or at all.
Even if we or our collaborators were able to obtain a license, the rights may
be
nonexclusive, which would give our competitors access to the same intellectual
property. Ultimately, we could be prevented from commercializing a product,
or
forced to cease some aspect of our business operations, as a result of patent
infringement claims, which could harm our business.
There
has
been substantial litigation and other proceedings regarding patent and other
intellectual property rights in the pharmaceutical and biotechnology industries.
Although we are not currently a party to any patent litigation or any other
adversarial proceeding, including any interference proceeding
declared
before the United States Patent and Trademark Office, regarding intellectual
property rights with respect to our products and technology, we may become
so in
the future. We are not currently aware of any actual or potential third party
infringement claim involving our products. The cost to us of any patent
litigation or other proceeding, even if resolved in our favor, could be
substantial. The outcome of patent litigation is subject to uncertainties that
cannot be adequately quantified in advance, including the demeanor and
credibility of witnesses and the identity of the adverse party, especially
in
biotechnology related patent cases that may turn on the testimony of experts
as
to technical facts upon which experts may reasonably disagree. Some of our
competitors may be able to sustain the costs of such litigation or proceedings
more effectively than we can because of their substantially greater financial
resources. If a patent or other proceeding is resolved against us, we may be
enjoined from researching, developing, manufacturing or commercializing our
products without a license from the other party and we may be held liable for
significant damages. We may not be able to obtain any required license on
commercially acceptable terms or at all.
-31-
Uncertainties
resulting from the initiation and continuation of patent litigation or other
proceedings could harm our ability to compete in the marketplace. Patent
litigation and other proceedings may also absorb significant management
time.
If
our products were derived from tissue or other samples from a patient without
the patient’s consent, we could be forced to pay royalties or cease selling our
products.
An
essential component of our business is our ability to obtain well-characterized
tissue and other samples from patients. To that end, we are negotiating an
agreement with the Institute of Pathology at the University of Regensburg in
Germany to collect samples of stomach, breast, prostate, and ovarian cancers
for
biomarker discovery programs focused on these cancers. Although we believe
that
all necessary consents will be obtained from any patient who donates samples
for
our research purposes, there is a risk that, without our knowledge and through
inadvertence, neglect, or willful misconduct, proper consents will not be
obtained from all patients. There is also a risk that the consents of some
or
all of the patients will not be enforceable. If a patient does not give a proper
consent and we develop a product using a sample obtained from him or her, we
could be forced to pay royalties or to cease selling that product.
If
we are unable to protect our intellectual property rights, our competitors
may
develop and market products with similar features that may reduce demand for
our
potential products.
The
following factors are important to our success:
· |
receiving
patent protection for our product
candidates;
|
· |
preventing
others from infringing our intellectual property rights;
and
|
· |
maintaining
our patent rights and trade
secrets.
|
We
will
be able to protect our intellectual property rights in patents and trade secrets
from unauthorized use by third
parties
only to the extent that such intellectual property rights are covered by valid
and enforceable patents or are effectively maintained as trade
secrets.
-32-
To
date,
we have sought to protect our proprietary position by filing a U.S. provisional
patent application related to inventions
that
form the basis of our research arrangements with the NIH and potential pipeline
of future products. We anticipate that we will apply for further patents based
on our ongoing research. Because issues of patentability involve complex legal
and factual questions, the issuance, scope and enforceability of patents cannot
be predicted with certainty. Patents, if issued, may be challenged, invalidated
or circumvented. U.S. patents and patent applications may also be subject to
interference proceedings, and U.S. patents may be subject to reexamination
proceedings in the U.S. Patent and Trademark Office and foreign patents may
be
subject to opposition or comparable proceedings in corresponding foreign patent
offices, which proceedings could result in either loss of the patent or denial
of the patent application or loss or reduction in the scope of one or more
of
the claims of the patent or patent application. In addition, such interference,
reexamination and opposition proceedings may be costly. Thus, any patents that
we own or license from others may not provide any protection against
competitors. Furthermore, an adverse decision in an interference proceeding
can
result in a third-party receiving the patent rights sought by us, which in
turn
could affect our ability to market a potential product to which that patent
filing was directed. Our pending patent applications, those that we may file
in
the future, or those that we may license from third parties may not result
in
patents being issued. If issued, they may not provide us with proprietary
protection or competitive advantages against competitors with similar
technology. Furthermore, others may independently develop similar technologies
or duplicate any technology that we have developed. Many countries, including
certain countries in Europe, have compulsory licensing laws under which a patent
owner may be compelled to grant licenses to third parties. For example,
compulsory licenses may be required in cases where the patent owner has failed
to “work” the invention in that country, or the third-party has patented
improvements. In addition, many countries limit the enforceability of patents
against government agencies or government contractors. In these countries,
the
patent owner may have limited remedies, which could materially diminish the
value of the patent. Moreover, the legal systems of certain countries,
particularly certain developing countries, do not favor the aggressive
enforcement of patent and other intellectual property protection which makes
it
difficult to stop infringement.
In
addition, our ability to enforce our patent rights depends on our ability to
detect infringement. It is difficult to detect infringers who do not advertise
the compounds that are used in their products. Any litigation to enforce or
defend our patent rights, even if we prevail, could be costly and
time-consuming
and
would divert the attention of management and key personnel from business
operations.
We
will
also rely on trade secrets, know-how and technology, which are not protected
by
patents, to maintain our competitive position. We will seek to protect this
information by entering into confidentiality agreements with parties that have
access to it, such as strategic partners, collaborators, employees and
consultants. Any of these parties may breach these agreements and disclose
our
confidential information or our competitors might learn of the information
in
some other way. If any trade secret, know-how or other technology not protected
by a patent were disclosed to, or independently developed by, a competitor,
our
business, financial condition and results of operations could be materially
adversely affected.
If
our third-party manufacturers’ facilities do not follow current good
manufacturing practices, our product development and commercialization efforts
may be harmed.
There
are
a limited number of manufacturers that operate under the FDA’s and European
Union’s good manufacturing practices regulations and are capable of
manufacturing products. Third-party manufacturers may
encounter difficulties in achieving quality control and quality assurance and
may experience shortages of qualified personnel. A failure of third-party
manufacturers to follow current good manufacturing practices or other regulatory
requirements and to document their adherence to such practices may lead to
significant delays in the availability of products for commercial use or
clinical study, the termination of, or hold on, a clinical study, or may delay
or prevent filing or approval of marketing applications for our products. In
addition we could be subject to sanctions being imposed on us, including fines,
injunctions and civil penalties. Changing manufacturers may require additional
clinical trials and the revalidation of the manufacturing process and procedures
in accordance with FDA mandated current good manufacturing practices and will
require FDA approval. This revalidation may be costly and time consuming. If
we
are unable to arrange for third-party manufacturing of our products, or to
do so
on commercially reasonable terms, we may not be able to complete development
or
marketing of our products.
-33-
If
we fail to obtain an adequate level of reimbursement for our products by
third-party payors, there may be no commercially viable markets for our products
or the markets may be much smaller than expected.
The
availability and levels of reimbursement by governmental and other third-party
payors affect the market for our products.
The efficacy, safety and cost-effectiveness of our products as well as the
efficacy, safety
and
cost-effectiveness of any competing products will determine the availability
and
level of reimbursement. These third-party payors continually attempt to contain
or reduce the costs of healthcare by challenging the prices charged for
healthcare products and services. In certain countries, particularly the
countries of the European Union, the pricing of prescription pharmaceuticals
is
subject to governmental control. In these countries, pricing negotiations with
governmental authorities
can take
six to twelve months or longer after the receipt of regulatory marketing
approval for a product. To obtain reimbursement or pricing approval in some
countries, we may be required to conduct clinical trials that compare the
cost-effectiveness of our products to other available therapies. If
reimbursement for our products is unavailable or limited in scope or amount
or
if pricing is set at unsatisfactory levels, our revenues would be
reduced.
Another
development that may
affect
the pricing of drugs is regulatory action regarding drug reimportation into
the
United States. The Medicare Prescription Drug, Improvement and Modernization
Act
of 2003, which became law in December 2003, requires the Secretary of the U.S.
Department of Health and Human Services to promulgate regulations allowing
drug
reimportation from Canada into the United States under certain circumstances.
These provisions will become effective only if the Secretary certifies that
such
imports will pose no additional risk to the public’s health and safety and
result in significant cost savings to consumers. To date, the Secretary has
made
no such finding, but he could do so in the future. Proponents of drug
reimportation may also attempt to pass legislation that would remove the
requirement for the Secretary’s certification or allow reimportation under
circumstances beyond those anticipated under current law. If legislation is
enacted, or regulations issued, allowing the reimportation of drugs, it could
decrease the reimbursement we would receive for any products that we may
commercialize, negatively affecting our anticipated revenues and prospects
for
profitability.
-34-
RISKS
RELATED TO CAPITAL STRUCTURE
There
is no assurance of an established public trading market, which would adversely
affect the ability of our investors to sell their securities in the public
market.
Although
our common stock is registered under the Exchange Act, our common stock is
not
and has never been publicly traded. As such, a regular trading market for the
securities does not yet exist and may not exist
or be
sustained in the future. The Company intends to seek a listing on the OTC
Bulletin Board. No assurance can be given that such listing will be obtained
or
the timing of the listing. Even if such listing is obtained, the NASD has
enacted recent changes that limit quotations on the OTC Bulletin Board to
securities of issuers that are current in their reports filed with the
Securities and Exchange Commission. The effect on the OTC Bulletin Board of
these rule changes and other proposed changes cannot be determined at this
time.
The OTC Bulletin Board is an inter-dealer, over-the-counter market that provides
significantly less liquidity than the NASD’s automated quotation system (the
“NASDAQ Stock Market”). Quotes for stocks included on the OTC Bulletin Board are
not listed in the financial sections of newspapers as are those for the NASDAQ
Stock Market. Therefore, prices for securities traded solely on the OTC Bulletin
Board may be difficult to obtain and holders of common stock may be unable
to
resell their securities at or near their original offering price or at any
price. Market prices for our common stock will be influenced by a number of
factors, including:
· |
the
issuance of new equity securities pursuant to a future offering or
acquisition;
|
· |
changes
in interest rates;
|
· |
competitive
developments, including announcements by competitors of new products
or
services or significant contracts, acquisitions, strategic partnerships,
joint ventures or capital
commitments;
|
· |
variations
in quarterly operating results;
|
· |
changes
in financial estimates by securities
analysts;
|
· |
the
depth and liquidity of the market for our common
stock;
|
· |
investor
perceptions of our company and the medical device industry generally;
and
|
· |
general
economic and other national
conditions.
|
Shares
eligible for future sale may adversely affect the market price of our common
stock, as the future sale of a substantial amount of outstanding stock in the
public marketplace could reduce the price of our common
stock.
The
former stockholder of Lixte who received shares of our stock in the Reverse
Merger will be eligible to sell all or some of his shares of common stock by
means of ordinary brokerage transactions in the open market pursuant to
Rule 144 promulgated under the Securities Act (“Rule 144”), commencing
one year after the Reverse Merger, subject to certain limitations. In general,
pursuant to Rule 144, a stockholder (or stockholders whose shares are
aggregated) who has satisfied a one-year holding period may, under certain
circumstances, sell within any three-month period a number of securities which
does not exceed the greater of 1% of the then outstanding shares of common
stock
or the average weekly trading volume of the class during the four calendar
weeks
prior to such sale if the shares are listed on a national exchange or on NASDAQ.
Rule 144 also permits, under certain circumstances, the sale of securities,
without any limitations, by a non-affiliate that has satisfied a two-year
holding period. Additionally, we have agreed to file a registration statement
covering the resale of shares issued in this offering and the shares owned
by
the shareholders of SRKP 7, Inc. immediately prior to the Reverse Merger.
Any substantial sale of common stock pursuant to any resale registration
statement or Rule 144 may have an adverse effect on the market price of our
common stock by creating an excessive supply.
-35-
Our
common stock is considered a “penny stock” and may be difficult to
sell.
Our
common stock is considered to be a “penny stock” since it meets one or more of
the definitions in Rules 15g-2 through 15g-6 promulgated under
Section 15(g) of the Exchange Act. These include but are not limited to the
following: (i) the stock trades at a price less than $5.00 per share;
(ii) it is NOT traded on a “recognized” national exchange; (iii) it is
NOT quoted on the NASDAQ Stock Market, or even if so, has a price less than
$5.00 per share; or (iv) it is issued by a company with net tangible assets
less than $2.0 million, if in business more than a continuous three years,
or with average revenues of less than $6.0 million for the past three
years. The principal result or effect of being designated a “penny stock” is
that securities broker-dealers cannot recommend the stock but must trade in
it
on an unsolicited basis.
Additionally,
Section 15(g) of the Exchange Act and Rule 15g-2 promulgated
thereunder by the SEC require broker-dealers dealing in penny stocks to provide
potential investors with a document disclosing the risks of penny stocks and
to
obtain a manually signed and dated written receipt of the document before
effecting any transaction in a penny stock for the investor’s
account.
Potential
investors in our common stock are urged to obtain and read such disclosure
carefully before purchasing any shares that are deemed to be “penny stock.”
Moreover, Rule 15g-9 requires broker-dealers in penny stocks to approve the
account of any investor for transactions in such stocks before selling any
penny
stock to that investor. This procedure requires the broker-dealer to
(i) obtain from the investor information concerning his or her financial
situation, investment experience and investment objectives; (ii) reasonably
determine, based on that information, that transactions in penny stocks are
suitable for the investor and that the investor has sufficient knowledge and
experience as to be reasonably capable of evaluating the risks of penny stock
transactions; (iii) provide the investor with a written statement setting
forth the basis on which the broker-dealer made the determination in (ii) above;
and (iv) receive a signed and dated copy of such statement from the
investor, confirming that it accurately reflects the investor’s financial
situation, investment experience and investment objectives. Compliance with
these requirements may make it more difficult for holders of our common stock
to
resell their shares to third parties or to otherwise dispose of them in the
market or otherwise.
-36-
Our
principal stockholder has significant influence over our
company.
As
a
result of the Reverse Merger, John Kovach, our principal stockholder, will
beneficially own approximately 69.10% of our outstanding voting stock after
giving effect to this offering (assuming the maximum amount of the Private
Placement is achieved). As a result, John Kovach possesses significant
influence, giving him the ability, among other things, to elect all of the
members of the Board of Directors and to approve significant corporate
transactions. Such stock ownership and control may also have the effect of
delaying or preventing a future change in control, impeding a merger,
consolidation, takeover or other business combination or discourage a potential
acquirer from making a tender offer or otherwise attempting to obtain control
of
us.
If
we fail to maintain effective internal controls over financial reporting, the
price of our common stock may be adversely affected.
Our
internal control over financial reporting may have weaknesses and conditions
that need to be addressed, the disclosure of which may have an adverse impact
on
the price of our common stock. We are required to establish and maintain
appropriate internal controls over financial reporting. Failure to establish
those controls, or any failure of those controls once established, could
adversely impact our public disclosures regarding our business, financial
condition or results of operations. In addition, management’s assessment of
internal controls over financial reporting may identify weaknesses and
conditions that need to be addressed in our internal controls over financial
reporting or other matters that may raise concerns for investors. Any actual
or
perceived weaknesses and conditions that need to be addressed in our internal
control over financial reporting, disclosure of management’s assessment of our
internal controls over financial reporting or disclosure of our public
accounting firm’s attestation to or report on management’s assessment of our
internal controls over financial reporting may have an adverse impact on the
price of our common stock.
Standards
for compliance with Section 404 of the Sarbanes-Oxley Act of 2002 are
uncertain, and if we fail to comply in a timely manner, our business could
be
harmed and our stock price could decline.
Rules
adopted by the SEC pursuant to Section 404 of the Sarbanes-Oxley Act of
2002 require annual assessment of our internal control over financial reporting,
and attestation of our assessment by our independent registered public
accountants. On September 22, 2005, the SEC extended the compliance dates
for non-accelerated filers, as defined by the SEC, by one year. Accordingly,
we
believe that this requirement will first apply to our annual report for fiscal
2008. The standards that must be met for management to assess the internal
control over financial reporting as effective are new and complex, and require
significant documentation, testing and possible remediation to meet the detailed
standards. We may encounter problems or delays in completing activities
necessary to make an assessment of our internal control over financial
reporting. In addition, the attestation process by our independent registered
public accountants is new and we may encounter problems or delays in completing
the implementation of any requested improvements and receiving an attestation
of
our assessment by our independent registered public accountants. If we cannot
assess our internal control over financial reporting as effective, or our
independent registered public accountants are unable to provide an unqualified
attestation report on such assessment, investor confidence and share value
may
be negatively impacted.
-37-
We
do not foresee paying cash dividends in the foreseeable
future.
We
have
not paid cash dividends on our stock and do not plan to pay cash dividends
on
our common stock in the foreseeable future.
We
may receive less than the maximum amount in the Private Placement.
As
of the
June 30, 2006 the Initial Private Placement grossed $657,299 in proceeds.
To the
extent that less than the maximum amount of the Private Placement is raised,
the
Company may not have sufficient funds to implement its business
plan.
DESCRIPTION
OF SECURITIES
We
are
authorized to issue 100,000,000 shares of Common Stock, par value $.0001 par
value per share 10,000,000 shares of preferred stock, par value $.0001 per
share, of which no shares are currently issued and outstanding. The preferred
stock may be issued in one or more series and our Board of Directors, without
further approval from its stockholders, is authorized to fix the dividend rights
and terms, conversion rights, voting rights, redemption rights, liquidation
preferences and other rights and restrictions relating to any series. Issuances
of preferred stock, while providing flexibility in connection with possible
financings, acquisitions and other corporate purposes, could, among other
things, adversely affect the voting power of the holders of our common
stock.
Market
Price of Our Common Stock
As
of the
date of this Report, there is no trading of our capital stock on any publicly
traded market. Even if such stock becomes publicly tradable, the price of our
common stock will likely fluctuate in the future. The stock market in general
has experienced extreme stock price fluctuations in the past few years. In
some
cases, these fluctuations have been unrelated to the operating performance
of
the affected companies. Many companies have experienced dramatic volatility
in
the market prices of their common stock. We believe that a number of factors,
both within and outside our control, could cause the price of our common stock
to fluctuate, perhaps substantially. Factors such as the following could have
a
significant adverse impact on the market price of its common stock:
· |
Our
ability to obtain additional financing and, if available, the terms
and
conditions of the financing;
|
· |
Our
financial position and results of
operations;
|
· |
Concern
as to, or other evidence of, the safety or efficacy of any future
proposed
products and services or our competitors’ products and
services;
|
· |
Announcements
of technological innovations or new products or services by us or
our
competitors;
|
-38-
· |
U.S.
and foreign governmental regulatory
actions;
|
· |
The
development of litigation against
us;
|
· |
Period-to-period
fluctuations in our operating
results;
|
· |
Changes
in estimates of our performance by any securities
analysts;
|
· |
Possible
regulatory requirements on our
business;
|
· |
The
issuance of new equity securities pursuant to a future
offering;
|
· |
Changes
in interest rates;
|
· |
Competitive
developments, including announcements by competitors of new products
or
services or significant contracts, acquisitions, strategic partnerships,
joint ventures or capital
commitments;
|
· |
Variations
in quarterly operating results;
|
· |
Change
in financial estimates by securities
analysts;
|
· |
The
depth and liquidity of the market for our common
stock;
|
· |
Investor
perceptions of us; and
|
· |
General
economic and other national
conditions.
|
Delaware
Anti-Takeover Law and Charter and Bylaw Provisions
We
are
subject to Section 203 of the Delaware General Corporation Law. This
provision generally prohibits a Delaware corporation from engaging in any
business combination with any interested stockholder for a period of three
years
following the date the stockholder became an interested stockholder,
unless:
· |
prior
to such date, the Board of Directors approved either the business
combination or the transaction that resulted in the stockholder becoming
an interested stockholder;
|
· |
upon
consummation of the transaction that resulted in the stockholder
becoming
an interested stockholder, the interested stockholder owned at least
85%
of the voting stock of the corporation outstanding at the time the
transaction commenced, excluding for purposes of determining the
number of
shares outstanding those shares owned by persons who are directors
and
also officers and by employee stock plans in which employee participants
do not have the right to determine confidentially whether shares
held
subject to the plan will be tendered in a tender or exchange offer;
or
|
-39-
· |
on
or subsequent to such date, the business combination is approved
by the
Board of Directors and authorized at an annual meeting or special
meeting
of stockholders and not by written consent, by the affirmative vote
of at
least 66 2/3% of the outstanding voting stock that is not owned by
the
interested stockholder.
|
Section 203
defines a business combination to include:
· |
any
merger or consolidation involving the corporation and the interested
stockholder;
|
· |
any
sale, transfer, pledge or other disposition of 10% or more of the
assets
of the corporation involving the interested
stockholder;
|
· |
subject
to certain exceptions, any transaction that results in the issuance
or
transfer by the corporation of any stock of the corporation to the
interested stockholder;
|
· |
any
transaction involving the corporation that has the effect of increasing
the proportionate share of the stock of any class or series of the
corporation beneficially owned by the interested stockholder;
or
|
· |
the
receipt by the interested stockholder of the benefit of any loans,
advances, guarantees, pledges or other financial benefits provided
by or
through the corporation.
|
In
general, Section 203 defines an “interested stockholder” as any entity or
person beneficially owning 15% or more of the outstanding voting stock of a
corporation, or an affiliate or associate of the corporation and was the owner
of 15% or more of the outstanding voting stock of a corporation at any time
within three years prior to the time of determination of interested stockholder
status; and any entity or person affiliated with or controlling or controlled
by
such entity or person.
Our
certificate of incorporation and bylaws contain provisions that could have
the
effect of discouraging potential acquisition proposals or making a tender offer
or delaying or preventing a change in control of us, including changes a
stockholder might consider favorable. These provisions include authorization
for
the issuance of up to 10,000,000 shares of preferred stock with designations,
rights and preferences determined from time to time by our Board of Directors.
Accordingly, our Board of Directors is empowered, without stockholder approval,
to issue preferred stock with dividend, liquidation, conversion, voting, or
other rights which could adversely affect the voting power or other rights
of
the holders of the common stock. In the event of issuance, the preferred stock
could be utilized, under certain circumstances, as a method of discouraging,
delaying or preventing a change in control of the Company.
Such
provisions may have the effect of discouraging a third-party from acquiring
us,
even if doing so would be beneficial to our stockholders. These provisions
are
intended to enhance the likelihood of continuity and stability in the
composition of our board of directors and in the policies formulated by them,
and to discourage some types of transactions that may involve an actual or
threatened change in control of our company. These provisions are designed
to
reduce our vulnerability to an unsolicited acquisition proposal and to
discourage some tactics that may be used in proxy fights. We believe that the
benefits of increased protection of our potential ability to negotiate with
the
proponent of an unfriendly or unsolicited proposal to acquire or restructure
our
company outweigh the disadvantages of discouraging such proposals because,
among
other things, negotiation of such proposals could result in an improvement
of
their terms. However, these provisions could have the effect of discouraging
others from making tender offers for our shares that could result from actual
or
rumored takeover attempts. These provisions also may have the effect of
preventing changes in our management.
-40-
Item 5.02.
Departure of Directors or Principal Officers; Election of Directors; Appointment
of Principal Officers.
Immediately
following the completion of the Exchange, all of the existing members of the
Company’s board of directors and all of its executive officers resigned and new
appointees comprised the Company’s board of directors as set forth in Item 5.01
of this Current Report on Form 8-K, which is incorporated by reference into
this Item 5.02.
Item 8.01
Other Events
As
a
result of the Exchange, the Company has moved its principal executive offices
to
248 Route 25A, No. 2, East Setauket, New York 11733.
Item 9.01
Financial Statements and Exhibits.
(a) Financial
Statements of Businesses Acquired.
The
financial statements of Lixte required by Rule 3-05(b) of Regulation S-X are
herewith filed.
(b) Exhibits.
2.1
|
Share
Exchange Agreement dated as of June 8, 2006 among the Company, John
S.
Kovach and Lixte Biotechnology,
Inc.
|
-41-
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
SRKP
7, INC.
|
||
|
|
|
Date: July 7, 2006 | By: | /s/ John S. Kovach |
John
S. Kovach, Chairman of the Board and Chief Executive Officer (principal
executive officer)
|
||
-42-
EXHIBIT
INDEX
Exhibit No.
|
Description
|
|
2.1
|
Share
Exchange Agreement dated as of June 8, 2006 among the Company, John
S.
Kovach, Lixte Biotechnology, Inc.
|
-43-
INDEX
TO FINANCIAL STATEMENTS
|
Page
|
|
Report
of Independent Registered Public Accounting Firm
|
F-2
|
Financial
Statements:
|
|
Balance
Sheets
|
F-3
|
Statements
of Operations
|
F-4
|
Statements
of Changes in Stockholder’s Equity (Deficit)
|
F-5
|
Statements
of Cash Flows
|
F-6
|
Notes
to Financial Statements
|
F-7
|
-44-
AJ.
ROBBINS, PC
CERTIFIED
PUBLIC ACCOUNTANTS
216
SIXTEENTH STREET
SUITE
600
DENVER,
COLORADO 80206
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the
Board of Directors
Lixte
Biotechnology, Inc.
East
Setauket, NY
We
have
audited the accompanying balance sheet of Lixte Biotechnology, Inc. (a
development stage company) as of December 31, 2005, and the related statements
of operations, changes in stockholder’s equity (deficit), and cash flows for the
period from August 9, 2005 (inception) to December 31, 2005. These financial
statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based
on
our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining on
a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used
and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In
our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Lixte Biotechnology, Inc. as of
December 31, 2005, and the results of its operations and its cash flows for
the
period from August 9, 2005 (inception) to December 31, 2005, in conformity
with
accounting principles generally accepted in the United States of America.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 1 to the financial
statements, the Company is in the development stage and has not commenced
operations. Its ability to continue as a going concern is dependent upon its
ability to develop additional sources of capital, locate and complete a merger
with another company and ultimately achieve profitable operations. These
conditions raise substantial doubt about its ability to continue as a going
concern. The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
AJ.
ROBBINS, PC
CERTIFIED
PUBLIC ACCOUNTANTS
Denver,
Colorado
February
27, 2006
F-2
LIXTE
BIOTECHNOLOGY, INC.
(A
Development Stage Company)
BALANCE
SHEETS
ASSETS
March
31,
|
December
31,
|
||||||
2006
|
2005
|
||||||
(Unaudited)
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
|
$
|
10,403
|
$
|
4,946
|
|||
EQUIPMENT,
net
|
1,149
|
1,026
|
|||||
$
|
11,552
|
$
|
5,972
|
||||
LIABILITIES
AND STOCKHOLDER’S EQUITY (DEFICIT)
|
|||||||
LIABILITIES:
|
|||||||
Accounts
Payable
|
$
|
1,850
|
$
|
14,650
|
|||
Due
to Stockholder
|
76,426
|
5,946
|
|||||
Total
Current Liabilities
|
78,276
|
20,596
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
STOCKHOLDER’S
EQUITY (DEFICIT):
|
|||||||
Common
stock, no par value, 1,500 shares authorized; 1,500 shares issued
and
outstanding
|
1,500
|
1,500
|
|||||
(Deficit)
accumulated during development stage
|
(68,224
|
)
|
(16,124
|
)
|
|||
Total
Stockholder’s Equity (Deficit)
|
(66,724
|
)
|
(14,624
|
)
|
|||
$
|
11,552
|
$
|
5,972
|
SEE
ACCOMPANYING NOTES TO FINANCIAL STATEMENTS
F-3
LIXTE
BIOTECHNOLOGY, INC.
(A
Development Stage Company)
STATEMENTS
OF OPERATIONS
For
the Three
Months
Ended
March
31, 2006
|
For
the Period
From
August 9,
2005
to
December
31, 2005
|
Cumulative
from
August
9, 2005
(Inception)
To
March
31 2006
|
||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||
REVENUE
|
$
|
---
|
$
|
---
|
$
|
---
|
||||
EXPENSES
|
52,100
|
16,124
|
68,224
|
|||||||
NET
(LOSS)
|
$
|
(52,100
|
)
|
$
|
(16,124
|
)
|
$
|
(68,224
|
)
|
|
NET
(LOSS) PER COMMON SHARE - BASIC
|
$
|
(34.73
|
)
|
$
|
(10.75
|
)
|
||||
WEIGHTED
AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
|
1,500
|
1,500
|
SEE
ACCOMPANYING NOTES TO FINANCIAL STATEMENTS
F-4
LIXTE
BIOTECHNOLOGY, INC.
(A
Development Stage Company)
STATEMENTS
OF CHANGES IN STOCKHOLDER’S EQUITY
FOR
THE PEROD FROM AUGUST 9, 2005 (INCEPTION)
TO
DECEMBER 31, 2005 AND
FOR
THE THREE MONTHS ENDED MARCH 31, 2006
(Unaudited)
Common
Stock
|
|||||||||||||
Shares
|
Amount
|
(Deficit)
Accumulated
During
Development
Stage
|
Total
Stockholder’s
Equity
(Deficit)
|
||||||||||
Balances,
August 9, 2005
|
---
|
$
|
---
|
$
|
---
|
$
|
---
|
||||||
Sale
of common stock on October 3, 2005 at $1.00 per share
|
1,500
|
1,500
|
-
|
1,500
|
|||||||||
Net
(loss)
|
---
|
---
|
(16,124
|
)
|
(16,124
|
)
|
|||||||
Balances,
December 31,2005
|
1,500
|
1,500
|
(16,124
|
)
|
(14,624
|
)
|
|||||||
Net
(loss) for the period
|
---
|
---
|
(52,100
|
)
|
(52,100
|
)
|
|||||||
Balances,
March 31, 2006 (Unaudited)
|
1,500
|
$
|
1,500
|
$
|
(68,224
|
)
|
$
|
(66,724
|
)
|
SEE
ACCOMPANYING NOTES TO FINANCIAL STATEMENTS
F-5
LIXTE
BIOTECHNOLOGY, INC.
(A
Development Stage Company)
STATEMENTS
OF CASH FLOWS
Cumulative
|
||||||||||
from
|
||||||||||
August
9,
|
||||||||||
2005
|
||||||||||
For
the Three
|
For
the Period
|
(Inception)
|
||||||||
Months
Ended
|
From
August 9,
|
To
|
||||||||
March
31,
|
2005
To
|
March
31,
|
||||||||
2006
|
December
31, 2005
|
2006
|
||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||
CASH
FLOWS FROM (TO) OPERATING ACTIVITIES:
|
||||||||||
Net
(loss)
|
$
|
(52,100
|
)
|
$
|
(16,124
|
)
|
$
|
(68,224
|
)
|
|
Adjustments
to reconcile net (loss) to net cash (used in) operating
activities:
|
||||||||||
Depreciation
|
115
|
113
|
228
|
|||||||
Changes
in :
|
||||||||||
Accounts
payable
|
(12,800
|
)
|
14,650
|
1,850
|
||||||
Net
Cash (Used in) Operating Activities
|
(64,785
|
)
|
(1,361
|
)
|
(66,146
|
)
|
||||
CASH
FLOWS FROM (TO) INVESTING ACTIVITIES:
|
||||||||||
Purchase
of equipment
|
(238
|
)
|
(1,139
|
)
|
(1,377
|
)
|
||||
Net
Cash (Used in) Investing Activities
|
(238
|
)
|
(1,139
|
)
|
(1,377
|
)
|
||||
CASH
FLOWS FROM (TO) FINANCING ACTIVITIES:
|
||||||||||
Common
stock issued for cash
|
---
|
1,500
|
1,500
|
|||||||
Advances
from stockholder
|
70,480
|
5,946
|
76,426
|
|||||||
Net
Cash Provided by Financing Activities
|
70,480
|
7,446
|
77,926
|
|||||||
NET
CHANGE IN CASH
|
5,457
|
4,946
|
10,403
|
|||||||
CASH
BEGINNING
|
4,946
|
---
|
---
|
|||||||
CASH
ENDING
|
$
|
10,403
|
$
|
4,946
|
$
|
10,403
|
SEE
ACCOMPANYING NOTES TO FINANCIAL STATEMENTS
F-6
LIXTE
BIOTECHNOLOGY, INC.
(A
Development Stage Company)
STATEMENTS
OF CASH FLOWS
NOTE
1 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
History
Lixte
Biotechnology, Inc. (“the Company”), a development stage company, was organized
under the laws of the State of Delaware on August 9, 2005. The Company is in
the
development stage as defined in Financial Accounting Standards Board Statement
No. 7. The fiscal year end is December 31.
In
April
2006, the Company changed its name to Lixte Biotechnology, Inc.
Going
Concern and Plan of Operation
The
Company’s financial statements have been presented on the basis that it is a
going concern, which contemplates the realization of assets and satisfaction
of
liabilities in the normal course of business. The Company is in the development
stage and has not earned any revenues from operations to date, which raises
substantial doubt about its ability to continue as a going concern.
The
Company’s ability to continue as a going concern is dependent upon its ability
to develop additional sources of capital, and ultimately achieve profitable
operations. The accompanying financial statements do not include any adjustments
that might result from the outcome of these uncertainties.
The
Company is currently devoting its efforts to research and development related
to
specific cancer biomarkers for early detection, estimation of prognosis,
monitoring response to treatment, and development of targeted therapeutic
agents. The Company is seeking to exploit this opportunity through execution
of
its business plan and the development of related patents.
Income
Taxes
The
Company uses the liability method of accounting for income taxes pursuant to
Statement of Financial Accounting Standards No. 109. Under this method, deferred
income taxes are recorded to reflect the tax consequences in future years of
temporary differences between the tax basis of the assets and liabilities and
their financial amounts at year end.
For
federal income tax purposes, substantially all expenses must be deferred until
the Company commences business and then they may be written off over 60-month
period. These expenses will not be deducted for tax purposes and will represent
a deferred tax asset. The Company will provide a valuation allowance in the
full
amount of the deferred tax asset since there is not assurance of future taxable
income. Tax deductible losses can be earned forward for 20 years until
utilized.
Cash
and Cash Equivalents
Cash
and
cash equivalents consist primarily of cash in banks and highly liquid
investments with original maturities of 90 days or less.
F-7
LIXTE
BIOTECHNOLOGY, INC.
(A
Development Stage Company)
STATEMENTS
OF CASH FLOWS
NOTE
1 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Equipment
Equipment
is recorded at cost. Depreciation expense is provided on a straight-line basis
using estimated useful lives of 3 years. Depreciation expense was $115 and
$113
for the periods ended March 31, 2006 and December 31, 2005, respectively.
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.
Concentrations
of Credit Risk
The
Company maintains all cash in deposit accounts, which at times may exceed
federally insured limits. The Company has not experienced a loss in such
accounts.
Earnings
Per Common Share
Earnings
per common share is computed based upon the weighted average number of common
shares outstanding during the period. Diluted earnings per share consists of
weighted average number of common shares outstanding plus the dilutive effects
of options and warrants calculated using the treasury stock method. In loss
periods, dilutive common equivalent shares are excluded as the effect would
be
anti-dilutive.
Use
of Estimates in the Preparation of Financial
Statements
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions
that
affect the reported amounts of asset and liabilities, the disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenue and expenses during the reporting periods.
Actual results could differ from those estimates and assumptions.
Recently
Issued Accounting Pronouncements
The
Company has adopted all recently issued accounting pronouncements. The adoption
of the accounting pronouncements is not anticipated to have a material effect
on
the operations of the Company.
.
NOTE
2 - EQUIPMENT
Equipment
consists of the following at:
March
31, 2006
|
December
31, 2005
|
||||||
Office
equipment
|
$
|
1,158
|
$
|
920
|
|||
Software
|
219
|
219
|
|||||
Total
|
1,377
|
1,139
|
|||||
Less
accumulated depreciation
|
(228
|
)
|
(113
|
)
|
|||
$
|
1,149
|
$
|
1,026
|
F-8
LIXTE
BIOTECHNOLOGY, INC.
(A
Development Stage Company)
STATEMENTS
OF CASH FLOWS
NOTE
3 - STOCKHOLDER’S EQUITY
During
October 2005, the Company issued 1,500 shares of its common stock to one
investor for $1,500.
NOTE
4 - RELATED PARTY TRANSACTIONS
Most
office services are provided without charge by the president. Such costs are
immaterial to the financial statements and accordingly, have not been reflected
therein. The officer and director of the Company is involved in other business
activities and may, in the future, become involved in other business
opportunities that become available, such person may face a conflict in
selecting between the Company and his other business interests. The Company
has
not formulated a policy for the resolution of such conflicts.
NOTE
5 - DUE TO STOCKHOLDER
Since
inception, a stockholder advanced the Company $76,426 to pay for operating
expenses. These funds have been advanced interest free.
F-9