CHAMPIONS ONCOLOGY, INC. - Annual Report: 2009 (Form 10-K)
Table of Contents
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-K
Mark One
þ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended April 30, 2009
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 0-17263
CHAMPIONS BIOTECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
Delaware | 52-1401755 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
855 N. Wolfe Street, Suite 619, Baltimore, MD 21205
(Address of principal executive offices, including zip code)
1400 N. 14th Street, Arlington, VA 22209
(Former address of principal executive offices)
(410) 369-0365
(Registrants telephone number, including area code)
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, par value $.001 per share
Common Stock, par value $.001 per share
(Title of Class)
Indicate by check mark if the registrant is a well-known seasoned issuer, as
defined in Rule 405 of the Securities Act. Yes o No þ
Indicate by check mark if the registrant is not required to file reports
pursuant to Section 13 or 15(d) of the Act.
Yes o No þ
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any,
every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes o No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K (§ 229.405) is not contained herein, and will not be
contained, to the best of the registrants knowledge, or in any definitive
proxy or information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this form 10-K.
o
Indicated by check mark whether the registrant is a large accelerated file, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See definitions of large accelerated filer, accelerated filer, and smaller
reporting company in Rule 12b-2 of the Exchange Act (check one):.
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
(do not check if a smaller reporting company) |
Indicate by check mark whether the registration is a shell company (as defined
in Rule 12b-2 of the Exchange Act). Yes o No þ
The Companys common stock is listed on the Over-The-Counter Bulletin Board
under the stock ticker symbol CSBR. The aggregate market value of the
registrants common stock held by non-affiliates of the Registrant based on the
average bid and asked price on October 31, 2008, was approximately $5,175,000.
As of
August 19, 2009, the Registrant had a total of 32,615,185 shares of
common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
None.
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PART IV |
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F-1 | ||||||||
Exhibit 3.1 | ||||||||
Exhibit 3.2 | ||||||||
Exhibit 10.4 | ||||||||
Exhibit 10.5 | ||||||||
Exhibit 10.6 | ||||||||
Subsidiaries of the Registrant | ||||||||
Rule 13a-14(a)/15d-14a(a) Certification of Principal Executive Officer | ||||||||
Rule 13a-14(a)/15d-14a(a) Certification of Chief Financial Officer | ||||||||
Section 1350 Certifications |
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As used in this Annual Report on Form 10-K, Champions Biotechnology, Champions,
Company,, we, ours, and us refer to Champions Biotechnology, Inc. and its subsidiaries,
except where the context otherwise requires or as otherwise indicated.
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
This document contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933 (Securities Act) and Section 21E of the Securities Exchange Act of 1934
(Exchanges Act) that inherently involve risk and uncertainties. The Company generally uses words
such as believe, may, could, will, intend, estimate, expect, anticipate, plan,
likely, should and similar expressions to identify forward-looking statements. Forward-looking
statements in this Annual Report include statements about our business strategies and product and
services development activities, including the anticipated benefits and risks associated with those
strategies as well as statements about the sufficiency of our capital resources. One should not
place undue reliance on these forward-looking statements. The Companys actual results could
differ materially from those anticipated in the forward-looking statements. Although the Company
believes the expectations reflected in the forward-looking statements are reasonable, they relate
only to events as of the date on which the statements are made, and the Companys future results,
levels of activity, performance or achievements may not meet these expectations. The Company does
not intend to update any of the forward-looking statements after the date of this document to
conform these statements to actual results or to changes in the Companys expectations, except as
required by law. As a result of these and other factors, our stock price may fluctuate
dramatically.
PART I
Item 1. | Business |
Development of Business
Champions Biotechnology, Inc. was incorporated as a merger and acquisition company under the
laws of the State of Delaware on June 4, 1985, under the name International Group, Inc. In
September 1985, the Company completed a public offering and shortly thereafter acquired the
world-wide rights to the Champions sports theme restaurant concept and changed its name to
Champions Sports, Inc. In 1997, the Company sold its Champions service mark and concept to
Marriott International, Inc. and until 2005, was a consultant to Marriott International, Inc. and
operated one Champions Sports Bar Restaurant. In January 2007, the Company changed its business
direction to focus on biotechnology and subsequently changed its name to Champions Biotechnology,
Inc. In February 2007, the Company acquired the patent rights to two Benzoylphenylurea (BPU) sulfur
analog compounds (SG410). On May 18, 2007, the Company acquired Biomerk, Inc. by issuing 4,000,000
unregistered shares of our common stock. On April 30, 2008, the Company issued 1,428,572
unregistered shares of our common stock at $1.75 per share pursuant to the terms of a private
investment financing. In March 2009, the Company formed Champions Biotechnology UK, Limited, a
wholly owned subsidiary, in order to establish a marketing operation in the United Kingdom and
Israel.
Current Business
The Company is engaged in the development of advanced preclinical platforms and predictive
tumor specific data to enhance and accelerate the value of oncology drugs. The Companys
preclinical platform is a novel approach based upon the implantation of primary human tumors in
immune deficient mice followed by propagation of the resulting xenografts (Biomerk Tumorgrafts) in
a manner that preserves the biological characteristics of the original human tumor. The Company
believes that Biomerk Tumorgrafts closely reflect human cancer biology and their response to drugs
is more predictive of clinical outcomes in cancer patients. The Company is building its Biomerk
Tumorgraft platform through the procurement, development and characterization of numerous
Tumorgrafts within several types of cancers. Tumorgrafts
are procured through agreements with institutions in the United States and Europe and developed and
tested through agreement with a U.S. based preclinical contract research organization.
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We
intend to leverage our preclinical platform to evaluate and to develop a portfolio of oncology drug candidates through preclinical
trials. The Company then plans to sell,
partner or license such drug candidates to pharmaceutical and/or biotechnology companies. We believe this
strategy will enable the Company to leverage the competencies of
these partners to maximize the Companys return on investment in
a shorter time frame than traditional
drug development. The Company believes that the use of our Tumorgraft models in the preclinical
development of oncology drugs is unlike that of many other biotechnology companies that look to
bring the process of drug development through all phases of discovery, development, regulatory
approvals, and marketing. Our model does not requires a very large
financial commitment or a long development
period, typically more than a decade, to realize a return on our drug
candidate investments. Thus far we have acquired two oncology
drug candidates of which we have begun preclinical development
through the use of contract facilities on the most promising candidate, SG410. We have secured a preclinical supply of SG410, more
recently developed a soluble form of the compound and plan to evaluate its efficacy in Biomerk
Tumorgrafts from several cancer types. The Company recently entered
into a Joint Development and Licensing Agreement with a third party
for the development of a soluble form of SG410. Under this Agreement,
the third party is entitled to milestone payments upon the success of
certain regulatory approvals and royalty payments on net sales of the
licensed product. If results are promising it is our
intention to continue preclinical development and then sell, partner or license SG410 for its
remaining clinical development.
The Company also offers its Biomerk Tumorgraft predictive preclinical platform and tumor
specific data to other biotechnology and pharmaceutical companies to provide information that may
enhance their drug development pipeline through the evaluation of oncology drugs in a platform that
integrates predictive testing with biomarker discovery. We provide Personalized Oncology Services
(POS) to physicians in the field of oncology by establishing and administering expert medical
information panels for their patients to analyze medical records and test results, to assist in
understanding conventional and experimental options and to identify and arrange for testing,
analysis and study of the patients cancer tissues, as appropriate. Additionally, Champions offers
Personalized Tumorgraft development and drug studies as part of its POS whereby physicians can
evaluate the effects of cancer therapies on their patients tumorgrafts enabling them to better select
treatment regimens that may be most efficacious to the patient. In the year ended April 30, 2009, our
revenues from POS grew 134%.
During
the fiscal year ended April 30, 2009, we began to offer leading pharmaceutical and biotechnology companies the benefits of our
Biomerk Tumorgrafts for their preclinical evaluation programs. Our Preclinical eValuation
services may be predictive of clinical outcomes and may provide for a
faster and less expensive path for drug approval. These services utilize Biomerk Tumorgrafts to
evaluate tumor sensitivity/resistance to various single and combination standard and novel
chemotherapy agents. The Preclinical eValuation services we offer also include biomarker discovery
and the identification of novel drug combinations. In the fourth quarter of fiscal year 2008, the
Company established an agreement with a leading drug development
company (The Drug Company) for
the preclinical evaluation of certain therapeutic antibodies in the drug companys clinical
development pipeline. As part of the agreement, The Drug Company will utilize our Biomerk
Tumorgrafts in the initial preclinical evaluation. We are currently providing services or in
discussions to provide Preclinical eValuation services to a number of
other companies. During fiscal year 2009, the Company
continued to expand its Preclinical eValuation business and had four customers under contract.
Operations
For the fiscal year ended April 30, 2009, the Company generated operating revenue of
$3,710,000, comprised of $3,278,000 from Personalized Oncology services and $432,000 Preclinical
eValuation services.
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Competition
Competition in the biotechnology industry is intense and based significantly on scientific,
technological and market forces. These factors include the availability of patent and other
protection for technology and products, the ability to commercialize technological developments and
the ability to obtain government approval for testing, manufacturing and marketing. The Company
faces significant competition from other biotechnology companies. The majority of these competitors
are and will be substantially larger than the Company, and have substantially greater resources and
operating histories. There can be no assurance that developments by other companies will not render
our products or technologies obsolete or noncompetitive or that we will be able to keep pace with
the technological or product developments of our competitors. These companies, as well as academic
institutions, governmental agencies and private research organizations also compete with us in
recruiting and retaining highly qualified scientific, technical and professional personnel and
consultants.
Our Preclinical Platform is proprietary and requires significant know-how to both initiate and
operate, but is not patented. It is, therefore, possible for competitors to develop other
implantation procedures or to discover the same procedures utilized by the Company that could
compete with the Company in its market.
Patent Applications
It is the Companys intention to protect its proprietary property through the filing of U.S.
and international patent applications, both broad and specific, where necessary and reasonable. In
February 2007, the Company acquired the patent applications to two Benzoylphenylurea (BPU) sulfur analog
compounds that have shown promising potent activity against invitro and invivo models of prostate
and pancreatic cancers. The acquired rights include pending U.S. Patent Application no. 11/673,519
and corresponding international patent application (PCT/US2006/014449) filed under the Patent
Cooperation Treaty (PCT), both entitled Design and Synthesis of Novel Tubulin Polymerization
Inhibitors: Benzoylphenylurea (BPU) Sulfur Analogs.
Research and Development
For the fiscal years ended April 30, 2009 and 2008, the Company spent approximately $1,721,000
and $200,000, respectively, on research and development to develop our preclinical platform and
expand our Preclinical eValuation Platform.
Government Regulation
The research, development, and marketing of the Companys products are subject to federal,
state, local, or foreign legislation or regulation, including the interpretation of and compliance
with existing, proposed, and future regulatory requirements imposed by the U.S. Food and Drug
Administration (FDA) in the United States and by comparable authorities in other countries. The
costs of bringing new drugs through the regulatory approval process and to the market are extremely
high, and the Company plans to sell, partner or license its drug candidates to pharmaceutical
and/or biotechnology companies, as appropriate prior to pursuing the FDA approval necessary to
commercially market its drug candidates.
Employees
As of April 30, 2009, the Company had 11 full-time employees.
Available Information
The
Company makes available free of charge on or through its internet website our annual
report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to
those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act. The
Companys website address is www.championsbiotechnology.com.
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Item 1A. | Risk Factors. |
You should carefully consider the risks described below together with all of the other
information included in this report. The risks and uncertainties described below are not the only
ones we face. Additional risks not presently known or those we currently consider insignificant
may also impair our business operations in the future.
We historically have lost money, expect losses for the foreseeable future, require significant
capital and may never achieve profitability.
We historically have lost money. For the fiscal years ended April 30, 2009 and 2008, the
Company had a net loss of $2,242,000 and $411,000, respectively. As of April 30, 2009, the Company
has an accumulated deficit of $9,757,000.
The amount of these losses may vary significantly from year-to-year and quarter-to-quarter and
will depend on, among other factors:
| the timing and cost of development for our preclinical platform, products and
technology; |
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| the progress and cost of preclinical and possibly early phase clinical development
programs; |
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| the cost of building out our Preclinical eValuation Tumorgraft platform; |
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| the cost and rate of progress toward growing our Personalized Oncology service
businesses; |
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| the cost of securing and defending our intellectual property; |
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| the timing and cost of obtaining necessary regulatory approvals; |
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| the cost of expanding and building out the infrastructure of our U.S. and overseas
operations; |
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| the cost incurred in hiring and maintaining qualified personnel; and |
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| the costs of any future litigation of which we may be subject. |
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| the cost of adopting the provisions of section 404 fo the Sarbenes-Oxley Act. |
Currently, the Company derives revenue from two sources: Personalized Oncology Services and
Preclinical eValuation Services, while we pursue drug development contracts. All of these business
activities require significant capital expenditures, and we have limited sources of revenue to
off-set such expenditures. Accordingly, we expect to generate operating losses in the future until
such time as we are able to generate more significant revenues.
To become profitable, we will need to generate revenues to off-set our operating costs,
including our general and administrative expenses. We may not achieve or, if achieved, sustain our
revenue or profit objectives, and our losses may increase in the future, and, ultimately, we may
have to cease operations.
In order to grow revenues, we must invest capital to successfully develop our drug candidates
and expand our Preclinical eValuation Tumorgraft platform. Our products may never achieve market
acceptance and we may never generate significant revenues or achieve profitability. If we must
devote a substantial amount of time to raising capital, it will delay our ability to achieve our
business goals within the time frames that we now expect, which could increase the amount of
capital we need. In addition, the amount of time expended by our management on fund raising
distracts them from concentrating on our business affairs.
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Our initial proposed drug products are in the early development stages and will likely not be
commercially introduced for many years, if at all.
Our proposed initial drug products, specifically two Benzoylphenylurea (BPU) sulfur analog
compounds are still in the early development stage and will require further development,
preclinical and early phase clinical testing and investment prior to our ability to sell, license
or partner with pharmaceutical and/or biotechnology companies. Such partnership, divestiture or
license agreement may have contingencies for their possible commercialization in the United States
and abroad. We cannot be sure that these products in development will:
| be successfully developed; |
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| prove to be safe and efficacious in preclinical or clinical trials; |
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| meet applicable regulatory standards or obtain required regulatory approvals; |
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| demonstrate substantial protective or therapeutic benefits in the prevention or
treatment of any disease; |
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| be capable of being formulated and/or produced in clinical or commercial
quantities at reasonable costs; |
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| obtain coverage and favorable reimbursement rates from insurers and other
third-party payors; or |
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| be successfully marketed or achieve market acceptance by physicians and patients. |
We have never marketed, sold or distributed a product and may need to rely on third parties to
successfully market and sell our products and generate revenues.
If we were to receive regulatory approval for our drug candidates, we will have to build a
marketing function or enter into agreements with contract sales organizations to market our
products. Our ability to gain market acceptance and generate revenues will be substantially
dependent upon our ability to build a marketing function and /or enter into such agreements on
favorable terms and to manage the efforts of those employees or service providers, as the case may
be.
We have very limited staffing and will continue to be dependent upon key employees.
Our success, currently, is dependent upon the efforts of 11 employees, the loss of the
services of one or more of which could have a material adverse affect on our business and financial
condition. We intend to continue to develop our management team and attract and retain qualified
personnel in all functional areas to expand and grow our business. This may be difficult in the
biotechnology industry where competition for skilled personnel is intense, even as the United
States sees an overall downturn in its economy.
Because our industry is very competitive and many of our competitors have substantially greater
capital resources and more experience in research and development, we may not succeed in developing
our products and technologies and having them brought to market.
We are engaged in a rapidly changing and highly competitive field. Potential competitors in
the United States and abroad are numerous and include pharmaceutical and biotechnology companies,
most of which have substantially greater capital resources and more experience in research and
development than us. Accordingly, our competitors may succeed in obtaining patent protection,
receiving FDA approval or commercializing of similar and competing drug candidates before we do.
We will compete with companies with greater marketing and manufacturing capabilities, areas in
which we have limited or no experience. We compete in a market that has a less than 10% success
rate in bringing new products to market.
Academic institutions, hospitals, governmental agencies and other public and private research
organizations are also conducting research and seeking patent protection and may develop and
commercially introduce competing products or technologies on their own or through joint ventures.
We cannot assure you that our competitors will not succeed in developing similar technologies and
products more rapidly than we do, commercially introducing such technologies and products to the
marketplace prior to introduction of our products, or that these competing technologies and
products will not be more effective or successful than any of those that we currently are
developing or will develop.
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Not only will the Company face competition from well established companies, new companies will
likely enter our market as scientific developments surrounding other cancer therapies continue to
accelerate in the multibillion dollar oncology marketplace.
If we are unable to protect our intellectual property, we may not be able to compete as
effectively.
It is important in the biotechnology industry to obtain patent and trade secret protection for
new technologies, products and processes. Our success will depend, in part, upon our ability to
obtain, enjoy and enforce protection for any products we develop or acquire under United States and
foreign patent laws and other intellectual property laws, preserve the confidentiality of our trade
secrets and operate without infringing the proprietary rights of third parties.
Where appropriate, we will seek patent protection for certain aspects of our technology.
However, our owned and licensed patents and patent applications may not ensure the protection of
our intellectual property for a number of reasons, including:
| Our preclinical platform is proprietary and requires significant know-how to both
initiate and operate, but is not patented. It is, therefore, possible for competitors to
develop other implantation procedures or to discover the same procedures utilized by the
Company that could compete with the Company in its market. |
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| If
we are successful in obtaining our patents, competitors may interfere with our patents and patent process in a variety of ways.
Competitors may claim that they invented the claimed invention before us or may claim that
we are infringing on their patents and, therefore, we cannot use our technology as claimed
under our patent. Competitors may also have our patents reexamined by showing the patent
examiner that the invention was not original or novel or was obvious. |
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| We are in the process of developing our proposed products and technologies. The
mere receipt of a patent does not necessarily provide practical protection. If we receive
a patent with a narrow scope, then it will be easier for competitors to design products
that do not infringe on our patent. Even if the development of our proposed products is
successful and approval for sale is obtained, there can be no assurance that applicable
patent coverage, if any, will not have expired or will not expire shortly after this
approval. Any expiration of the applicable patent could have a material adverse effect on
the sales and profitability of our proposed product. |
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| Obtaining and enforcing patents is expensive and may require significant time by
our management. In litigation, a competitor could claim that our issued patents are not
valid for a number of reasons. If the court agrees, we would lose protection on products
covered by those patents. |
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| We also may support and collaborate in research conducted by government
organizations or universities. We cannot guarantee that we will be able to acquire any
exclusive rights to technology or products derived from these collaborations. Obtaining
the required or necessary licenses or rights from such collaborative research can be time
consuming and expensive. If we do not obtain required licenses or rights, we could
encounter delays in product development while we attempt to design around other patents or
we may be prohibited from developing, manufacturing or selling products requiring these
licenses. There is also a risk that disputes may arise as to the rights to technology or
products developed in collaboration with other parties. |
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| It also is unclear whether efforts to secure our trade secrets will provide useful
protection. While we will use reasonable efforts to protect our trade secrets, our
employees or consultants may unintentionally or willfully disclose our proprietary
information to competitors resulting in a loss of protection. Enforcing a claim that
someone else illegally obtained and is using our trade secrets, like patent litigation, is
expensive and time consuming, and the outcome is unpredictable. In addition, courts
outside the United States are sometimes less willing to protect trade secrets. Finally,
our competitors may independently develop equivalent knowledge, methods and know-how. |
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Claims by others that our products infringe their patents or other intellectual property rights
could adversely affect our financial condition.
The biotechnology industry has been characterized by frequent litigation regarding patent and
other intellectual property rights. Patent applications are maintained in secrecy in the United
States and also are maintained in secrecy outside the United States until the application is
published. Accordingly, we can conduct only limited searches to determine whether our technology
infringes the patents or patent applications of others. Any claims of patent infringement asserted
by third parties would be time-consuming and could likely:
| result in costly litigation; |
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| divert the time and attention of our technical personnel and management; |
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| cause product development delays; |
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| require us to develop non-infringing technology; or |
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| require us to enter into royalty or licensing agreements. |
Although patent and intellectual property disputes in the biotechnology industry have often
been settled through licensing or similar arrangements, costs associated with these arrangements
may be substantial and often require the payment of ongoing royalties, which could hurt our gross
margins. In addition, we cannot be sure that the necessary licenses would be available to us on
satisfactory terms, or that we could redesign our products or processes to avoid infringement, if
necessary. Accordingly, an adverse determination in a judicial or administrative proceeding, or the
failure to obtain necessary licenses, could prevent us from developing, manufacturing and selling
some of our products, which could harm our business, financial condition and operating results.
If any of our products that we license or partner with pharmaceutical and/or biotechnology
companies fail to obtain regulatory approval or if approval is delayed or withdrawn, we may be
unable to generate revenue from the sale or license of our products.
Our products are subject to federal, state, local, or foreign legislation or regulation,
including the interpretation of and compliance with existing, proposed, and future regulatory
requirements imposed by the FDA in the United States and by comparable authorities in other
countries. In the United States, approval of the FDA has to be obtained for each drug to be
commercialized. The FDA approval process is typically lengthy and expensive, and approval is never
certain. Products to be commercialized abroad are subject to similar foreign government regulation.
Generally, only a very small percentage of newly discovered pharmaceutical products that enter
preclinical development are approved for sale. Because of the risks and uncertainties in
biopharmaceutical development, our proposed drug products could take a significantly longer time to
gain regulatory approval than we expect or may never gain approval. If regulatory approval is
delayed or never obtained, our managements credibility, the value of our company and our operating
results and liquidity might be adversely affected. Furthermore, even if a product gains regulatory
approval, the product and the manufacturer of the product may be subject to continuing regulatory
review. Even after obtaining regulatory approval, such approval may entail limitations on the
indicated uses for which the product may be marketed. Moreover, a marketed product, its
manufacturer, its manufacturing facilities, and its suppliers are subject to continual review and
periodic inspections. Discovery of previously unknown problems, or the exacerbation of problems
previously deemed acceptable, with the product, manufacturer, or facility may
result in restrictions on such product or manufacturer, potentially including withdrawal of the
product from the market.
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Even if our proposed products receive FDA approval, they may not achieve expected levels of market
acceptance, which could have a material adverse effect on our business, financial position and
operating results and could cause the market value of our common stock to decline.
Even if our proposed products obtain required regulatory approvals, the success of those
products is dependent upon market acceptance by physicians and patients. Levels of market
acceptance for our new products could be impacted by several factors, including:
| the availability of alternative products from competitors; |
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| the price of our products relative to that of our competitors; |
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| the timing of our market entry; and |
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| the ability to promote our products effectively against well funded
companies that have more experience in the marketing of approved
drugs. |
Some of these factors are not within our control. Our proposed products may not achieve
expected levels of market acceptance. Additionally, continuing studies of the proper utilization,
safety and efficacy of pharmaceutical products are being conducted by the industry, government
agencies and others. Such studies, which increasingly employ sophisticated methods and techniques,
can call into question the utilization, safety and efficacy of previously marketed products. In
some cases, these studies have resulted, and may in the future result, in the discontinuance of
product marketing. These situations, should they occur, could have a material adverse effect on our
business, financial position and results of operations, and the market value of our common stock
could decline.
Because the biotechnology industry is heavily regulated, we face significant costs and
uncertainties associated with our efforts to comply with applicable regulations. Should we fail to
comply, we could experience material adverse effects on our business, financial position and
results of operations, and the market value of our common stock could decline.
The biotechnology industry is subject to regulation by various federal and state governmental
authorities. For example, we must comply with FDA requirements with respect to the development of
our proposed products and our early clinical trials, and if any of our proposed products are
approved, the manufacture, labeling, sale, distribution, marketing, advertising and promotion of
our products. Failure to comply with FDA and other governmental regulations can result in fines,
disgorgement, unanticipated compliance expenditures, recall or seizure of products, total or
partial suspension of production and/or distribution, suspension of the FDAs review of New Drug
Applications (NDAs), enforcement actions, injunctions and criminal prosecution. Under certain
circumstances, the FDA also has the authority to revoke previously granted drug approvals. Despite
our efforts at compliance, there is no guarantee that we may not be deemed to be deficient in some
manner in the future. If we were deemed to be deficient in any significant way, our business,
financial position and results of operations could be materially affected.
If our CRO facility that handles a majority of our Preclinical eValuation studies and Tumorgraft
platform development is damaged or destroyed, our business would be negatively affected.
We currently utilize a Contract Research Organization (CRO) to perform a majority of our
tumor studies and develop and bank our tumorgraft platform. If that facility were to be
significantly damaged or destroyed, we could suffer a loss of some our ongoing and future drug
studies as well as our Tumorgraft bank. While we believe that our CRO has risk management
procedures in place and is insured against damage, such an event would delay timelines and require
additional time to restore operations back to the baseline. Additional means are being put into
place whereby our tumorgraft bank will be housed in two different states to avoid a catastrophic
event damaging our tumorgraft bank.
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Your investment in our common stock may be diluted if we issue additional shares in the future.
We may issue additional shares of common stock, which would reduce your percentage ownership
and may dilute your share value. Our Certificate of Incorporation authorizes the issuance of
50,000,000 shares of common stock. As of August 19, 2009, we had 33,578,903 shares of
common stock issued and 32,615,185 shares outstanding. The future issuance of all or part of the
remaining authorized common stock would result in substantial dilution in the percentage of the
common stock held by existing shareholders. The issuance of common stock for future services or
acquisitions or other corporate actions may have the effect of diluting the value of the shares
held by existing shareholders, and might have an adverse effect on any trading market for our
common stock.
There is a limited trading market for our common stock, which may make it difficult for you to sell
your shares.
Our common stock is quoted on the OTC Bulletin Board. Like many stocks quoted on the OTC
Bulletin Board, trading in our common stock is thin and characterized by wide fluctuations in
trading prices, due to many factors that may have little to do with our operations or business
prospects. This volatility could depress the market price of our common stock for reasons unrelated
to operating performance. Moreover, trading on the OTC Bulletin Board is often more sporadic and
volatile than the trading on security exchanges like NASDAQ, American Stock Exchange or New York
Stock Exchange. Accordingly, you may have difficulty reselling your shares of our common stock in
short time periods.
Our stock price is volatile.
The stock market in general and the market for biotechnology companies in particular have
experienced extreme volatility that has often been unrelated to the operating performance of
particular companies. As a result of this volatility, investors may not be able to sell their
common stock at or above the price they paid for it. The market price for our common stock may be
influenced by many factors, including:
| results of clinical trials of our drug candidates or those of our
competitors: |
||
| regulatory development in the United States and foreign countries; |
||
| variations in our financial results or those of companies that are perceived
to be similar to us; |
||
| changes in the healthcare payment system; |
||
| announcements by us of significant acquisition, strategic partnerships, joint
ventures or capital commitments; |
||
| sales of significant shares of stock by large investors; |
||
| significant 8-K disclosures such as a change in management or the need to
restate prior audits; |
||
| intellectual property, product liability, or other litigation against us; |
||
| the loss of a key development partner or CRO; and |
||
| the other key facts described in this Risk Factors section. |
Our common stock may be deemed a penny stock, which would make it more difficult for you to sell
your shares.
Our common stock may be subject to the penny stock rules adopted under Section 15(g) of the
Securities Exchange Act of 1934, as amended (the Exchange Act). The penny stock rules apply to
companies whose common stock is not listed on the NASDAQ Stock Market or another national
securities exchange and trades at less than $5.00 per share or that have tangible net worth of less
than $5,000,000 ($2,000,000 if the company has been operating for three or more years). These rules
require, among other things, that brokers who trade penny stock to persons other than established
customers complete certain documentation, make suitability inquiries of investors and provide
investors with certain information concerning trading in the security, including a risk disclosure
document and quote information under certain circumstances. Many brokers have decided not to trade
penny stocks because of the requirements of the penny stock rules and, as a result, the number of
broker-dealers willing to act as market makers in such
securities is limited. If we remain subject to the penny stock rules for any significant period, it
could have an adverse effect on the market, if any, for our common stock. Because our common stock
is subject to the penny stock rules, you may find it more difficult to dispose of the shares of our
common stock that you have purchased.
11
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Material
weakness or deficiencies in our internal control over financial reporting could harm
stockholder and business confidence in our financial reporting, our ability to obtain financing,
and other aspects of our business.
Our management evaluated the effectiveness of the design and operation of our disclosures
controls and procedures as of the fiscal year ended April 30,
2009 and concluded that our
disclosure controls and procedures were not effective as of those dates, because of material
weakness in our internal control over financial reporting. A material weakness is a control
deficiency, or combination of control deficiencies that results in more than a remote likelihood
that material misstatement of the annual or interim financial statements will not be prevented or
detected. During the 2008 audit, our independent registered public
accounting firm identified a material weakness in our internal
control over financial reporting. This material weakness consisted
primarily of inadequate staffing and supervision that could lead to
the untimely identification and resolution of accounting and
disclosure matters and failure to perform timely and effective
reviews.
On June 26, 2009 the Company filed a Form 8K disclosing the fact that the Companys April
30, 2008 Form 10-KSB included financials that could no longer be relied on due to identifying
errors in reporting for stock-based compensation. The Company
subsequently filed a Form 10-KSB/A in August 2009, detailing the
reasons behind the material weakness and restatement.
During fiscal
2009, the Company also identified material weaknesses in the
application of U.S. GAAP to share based compensation issued to
non-employee consultants, accounting for revenue recognition and
prepaid costs under the personalized oncology cancer vaccine
development services agreements, and the Companys financial
statement close process, which have been discussed in more detail in
Item 9A(T). As a result of this restatement and material
weaknesses, customers, stockholders and other potential investors could lose confidence in our
financial reporting which could adversely impact the availability and cost of capital as well as
other aspects of our business.
Certain provisions of Delaware law and of our charter and bylaws contain provisions that could
delay and discourage takeover attempts and any attempts to replace our current management by
shareholders.
Certain provisions of our certificate of incorporation and bylaws, and applicable provisions
of Delaware corporate law, could make it difficult for or prevent a third party from acquiring
control of us or changing our Board of Directors and management. These provisions include:
| the ability of our Board of Directors to issue preferred stock with voting or
other rights or preferences; |
||
| the inability of stockholders to act by written consent; and |
||
| requirements that our stockholders comply with advance notice procedures in
order to nominate candidates for election to our Board of Directors or to place
stockholders proposals on the agenda for consideration at meetings of stockholders. |
Insiders own a significant amount of the outstanding common stock
Insiders own a significant amount of our outstanding common stock which could discourage
takeover attempts.
Item 2. | Properties. |
The Company leases office and laboratory space at 855 N. Wolfe Street, Suite 619, Baltimore,
MD 21205 and office space at 2050 E. ASU Circle, Suite 103, Tempe, AZ 85284. The Companys
aggregate rental payments are $10,200 per month.
Item 3. | Legal Proceedings. |
None.
Item 4. | Submission of Matters to a Vote of Security Holders. |
None.
12
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PART II
Item 5. | Market For Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of
Equity Securities. |
Principal Market or Markets
The following information sets forth the high and low quotation price for the Companys common
stock for each quarter within the last two fiscal years. The Companys common stock (symbol CSBR)
is traded over-the-counter (OTC) and quoted on the electronic Bulletin Board maintained by the
National Association of Securities Dealers. The quotations represent prices between dealers and do
not reflect the retailer markups, markdowns or commissions, and may not represent actual
transactions. The Companys securities are presently classified as Penny Stocks as defined by
existing securities laws. This classification places significant restrictions upon broker-dealers
desiring to make a market in such securities.
Common Stock | ||||||||
High | Low | |||||||
$ | $ | |||||||
Fiscal 2009 |
||||||||
First Quarter |
1.40 | 0.60 | ||||||
Second Quarter |
1.15 | 0.25 | ||||||
Third Quarter |
1.19 | 0.33 | ||||||
Fourth Quarter |
1.25 | 0.71 |
High | Low | |||||||
$ | $ | |||||||
Fiscal 2008 |
||||||||
First Quarter |
0.80 | 0.26 | ||||||
Second Quarter |
2.15 | 0.35 | ||||||
Third Quarter |
1.90 | 0.80 | ||||||
Fourth Quarter |
1.50 | 0.77 |
Approximate Number of Holders of Common Stock
As of August 10, 2009, there were approximately 2,100 record holders of the Companys common
stock.
Dividends
Holders of our common stock are entitled to receive such dividends as may be declared by the
Companys Board of Directors. No dividends have been paid with respect to the Companys common
stock and no dividends are anticipated to be paid in the foreseeable future. Any future decisions
as to the payment of dividends will be at the discretion of the Companys Board of Directors,
subject to applicable law.
Securities Authorized for Issuance Under Equity Compensation Plans
The information regarding securities authorized for issuance under our equity compensation
plans is disclosed in Item 12 Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters.
13
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Recent Sales by the Company of Unregistered Securities
On April 30, 2008, the Company issued 1,428,572 unregistered shares of the Companys common
stock at $1.75 per share, for a total of $2,500,000, pursuant to the terms of a private investment
financing. The shares were issued to two non-US subscribers outside the United States. All the
unregistered shares issued in this offering were issued in a private transaction exempt from
registration pursuant to Regulation S of the Securities Act of
1933. The offering was not a public offering
and was not accompanied by any general advertisement or any general solicitation. The Company
received, from each of the two subscribers, a completed and signed subscription agreement
containing certain representations and warranties, including, among others, that (a) the subscriber
was not a U.S. person, (b) the subscriber subscribed for the shares for their own investment
account and not on behalf of a U.S. person, and (c) there was no prearrangement for the sale of the
shares with any buyer. No offer was made or accepted in the United States and the share
certificates representing the shares were issued bearing a legend with the applicable trading
restrictions.
Item 7. | Managements Discussion and Analysis of Financial Condition and Results of Operations. |
The following discussion and analysis is provided to further the readers understanding of the
consolidated financial statements, financial condition and results of operations of the Company.
This discussion should be read in conjunction with the consolidated financial statements and the
accompanying notes included in this Annual Report on Form 10-K.
Overview
In January 2007, the Company changed its business direction to focus on biotechnology and
changed its name to Champions Biotechnology, Inc. The Company is engaged in the development of
advanced preclinical platforms and predictive tumor specific data to enhance and accelerate the
value of oncology drugs. The Companys Preclinical eValuation Platform is a novel approach based
upon the implantation of primary human tumors in immune deficient mice followed by propagation of
the resulting xenografts (Biomerk Tumorgrafts) in a manner that preserves the biological
characteristics of the original human tumor. The Company believes that Biomerk Tumorgrafts closely
reflect human cancer biology and their response to drugs is more predictive of clinical outcomes in
cancer patients. The Company is building its Biomerk Tumorgraft platform through the procurement,
development and characterization of numerous Tumorgrafts within several types of cancers.
Tumorgrafts are procured through agreements with institutions in the United States and Europe and
developed and tested through agreement with a U.S. based preclinical CRO.
The Company also offers its Biomerk Tumorgraft predictive Preclinical eValuation Platform and
tumor specific data to physicians to provide information that may enhance personalized patient care
options and to companies for evaluation of oncology drugs in a platform that integrates predictive
testing with biomarker discovery. In providing patient care options the Company administers expert
medical panels with participants that are selected based on the patients specific cancer type and
condition. A panel typically includes renowned experts from each of the disciplines that may be
critical to the patients status and treatment including oncologists, radiologists, surgeons,
pathologists and research experts from both academia and the pharmaceutical/biotechnology industry.
Experts review various treatment approaches designed to maximize options available to the treating
physician. In addition we offer Personalized Tumorgrafts from the respective patients tumor. To
accomplish this, the physician obtains a sample of the patients tumor which is then immediately
implanted in immune deficient mice and propagated in a manner that preserves the biological
properties of the original tumor. Development of the Personalized Tumorgrafts may enable extensive
in vivo testing of numerous novel and standard drugs and drug combinations. This targeted process
typically provides data regarding the drug/drug combinations that are the most and least effective.
This data may be useful to the patients physician in evaluating future treatment options for the
patient.
During the year ended April 30, 2009,
we began to offer leading pharmaceutical and biotechnology companies the benefits of our Biomerk
Tumorgrafts for their preclinical evaluation programs. Our Preclinical eValuation
services may be more predictive of clinical outcomes and may provide for a
faster and less expensive path for drug approval. These services utilize Biomerk Tumorgrafts to
evaluate tumor sensitivity/resistance to various single and combination standard and novel
chemotherapy agents. The Preclinical eValuation services we offer also include biomarker discovery
and the identification of novel drug combinations.
14
Table of Contents
We intend to leverage our preclinical platform to evaluate and develop a portfolio of oncology drug candidates through pre-clinical
trials. The Company then plans to sell, partner or license such drug
candidates to
pharmaceutical and/or biotechnology companies. We believe this strategy will enable the Company to
leverage the competencies of these partners to maximize the Companys return on
investment in a relatively short time frame. The Company believes that this model is unlike that
of many new biotechnology companies that look to bring the process of drug development through all
phases of discovery, development, regulatory approvals, and
marketing. Our model does not require a very large
financial commitment or a long development period, typically more
than a decade, to realize a return on our drug candidate investments.
Thus far we have acquired two oncology drug candidates of which we have begun preclinical development
through the use of contract facilities on the most promising candidate, SG410. We have secured a
preclinical supply of SG410 and more recently developed a soluble form of the compound and plan to
evaluate its efficacy in Biomerk Tumorgrafts from several cancer
types. The Company recently entered into a Joint Development and
Licensing Agreement with a third party for the development of a
soluble form of SG410. Under this Agreement the third party is
entitled to milestone payments upon the success of certain regulatory
approvals and royalty payments on net sales of the licensed product. To date no royalties or milestone payments have been
earned or paid. If results are promising
it is our intention to continue preclinical development and then sell, partner or license SG410 for
its remaining clinical development.
Results of Operations
Fiscal Years ended April 30, 2009 and April 30, 2008
Revenues:
For the fiscal years ended April 30, 2009 and 2008, the Companys revenues from operations were
$3,710,000, and $1,400,000, respectively, an increase of $2,310,000 or 165%. The increase of
$2,310,000 was comprised of $1,878,000 from Personalized Oncology services and $432,000 from our
Preclinical eValuation services which began generating revenues during fiscal 2009. For the fiscal
year ended April 30, 2008, all of our revenues were generated from our Personalized Oncology
business.
Revenues generated in our Personalized Oncology business related to Personalized Oncology
Panels, Tumorgraft implantations and related Tumorgraft studies. The overall increase in the
Personalized Oncology business is attributable to a greater demand for our services and the
additional service offerings we added in the fiscal year.
Revenues related to the Companys Preclinical eValuation business represented studies we
completed for a number of pharmaceutical and biotech companies where
we utilized our Biomerk Tumorgrafts to test against various
drugs candidates to show how predictive the drug candidates would be in a clinical setting. The Preclinical
eValuation business began generating revenues in fiscal year 2009 and generated no revenues in the
fiscal year 2008.
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Expenses:
For the fiscal years ended April 30, 2009 and 2008, the Companys operating expenses were
$6,040,000 and $1,840,000, respectively, an increase of $4,200,000 or 228%.
| Cost of Personalized
Oncology Services (CPOS): For the fiscal year ended April
30, 2009 and 2008, CPOS were $1,623,000 and $490,000, respectively, an increase of
$1,133,000 or 231%. CPOS expenses consist of salaries, employee related costs, stock-based
compensation costs, and the costs of conducting panels which include honoraria, travel,
medical testing and related event costs. |
||
In addition, in December 2008, the Company began offering
personalized oncology vaccine development services and received a total of
$580,000 from the first two clients enrolled in the
vaccine development program, which was recorded as deferred revenue.
The Company agreed to prepay certain development partners $500,000 related to
initial start up costs per these personalized oncology vaccine
development service agreements, which was recorded as a prepaid expense. During
the fiscal year ended April 30, 2009, we charged approximately $146,000 of the prepaid
services under this agreement to CPOS expense for services provided by
our development partners. |
|||
|
Cost of Preclinical eValuation services: For the years ended April 30, 2009
and 2008, cost of Preclinical eValuation services were $357,000 and
zero, respectively. Cost of Preclinical
eValuation services consist of salaries, employee benefits, stock based compensation and
the costs associated with a CRO that we contract with for propagation and testing of the
Biomerk Tumorgrafts. |
||
| Research and Development: For the years ended April 30, 2009 and 2008,
research and development expenses were $1,721,000 and $200,000, respectively, an increase
of $1,521,000 or 760%. The increase was mainly attributable to the fact that the Company
did not have a significant research and development effort ongoing for a majority of the
fiscal 2008 year other then the procurement of a limited supply of Tumorgrafts. Research
and development expenses incurred in the 2009 fiscal year represent salaries, related
benefits, share-based compensation, consultants, travel, Tumorgraft acquisition costs, and
their subsequent propagation, storage, characterization and storage and handling fees.
Also included in research and development expense is the cost of a research and
development team that is tasked with identifying and securing the Companys future drug
pipeline candidates. These research and development costs consisted mainly of consulting
and travel expenses. |
||
|
Impairment of Intangible Assets: During the year ended
April 30, 2009, we
recorded a $284,000 impairment expense related to the valuation of certain patent rights.
The Companys
Polymerization Inhibitors: Benzoylphenylurea (BPU) Sulfur Analogs patent applications were
acquired in 2007 and since then the Company has spent approximately
$100,000 on ongoing patent legal fees in anticipation of pursuing
licensing or development partnering opportunities for these patents.
During the fourth quarter of fiscal 2009, the Company identified
indicators of impairment in its BPU patents based on changes in the
current market conditions and expectations of near term
commercialization. SFAS
No. 144 Accounting for the Impairment or Disposal of
Long-Lived Assets requires an impairment loss be recognized for
an amortizable intangible asset whenever the net cash in-flow to be
generated from an asset is less than its carrying cost. As the
Company was unable to determine the timing or amount of net cash
in-flow to be generated from a BPU licensing and/or partnering
agreement, we were unable to support the carrying value of the intangible asset. Notwithstanding the
impairment of the patent rights we are continuing our efforts to perfect the patent and
seek licensing and partnering opportunities for further development. |
||
| General and Administration: For the fiscal years ended April 30, 2009 and
2008, general and administrative expenses were $2,055,000 and $1,150,000, respectively, an
increase of $905,000 or 79%. General and administrative expenses saw a significant
increase due to the fact that the Company was just beginning to expand operations in
fiscal 2008 with only four employees. During fiscal 2009, the Company continued to build
out its management team and infrastructure to meet the requirements of a public company.
General and administrative expenses included salaries and related
benefits, stock-based compensation, audit, legal,
insurance, investor relations, marketing and sales, rent and recruiting. |
||
| Interest Income:
Interest income increased to $88,000 for the year ended
April 30, 2009 compared to $29,000 for fiscal 2008. The increase
of $59,000 was due to the Company investing in a certificate of
deposit in fiscal 2009. |
16
Table of Contents
Net Loss:
The Companys net loss for the years ended April 30, 2009 and 2008 was $2,242,000 and
$411,000, respectively. The $1,831,000 increase in our net loss for the year ended April 30, 2009
reflects the $1,490,000 increase in service expenses and the $1,521,000 and $905,000 increase in
research and development costs and general and administrative expenses, respectively, and an
impairment charge of $284,000 offset by a $2,310,000 increase in service revenues and a $59,000
increase in interest income.
Liquidity and Capital Resources
The Companys available liquid capital as of April 30, 2009, amounted to $2,745,000 (consisting
of cash and cash equivalents of $1,728,000 and a certificate of deposit of $1,017,000) compared to $3,709,000
on April 30, 2008. In June 2009, the certificate of deposit matured and was converted to cash.
For the years ended April 30, 2009 net cash used by operations was $888,000 compared to
$792,000 provided by operations during the year ended April 30, 2008. The decrease of $1,680,000
in cash provided by operations reflects the $1,831,000 increase in
our net loss and a $153,000 decrease in stock-based compensation offset by a net
$16,000 increase in cash provided by the change in operating assets and liabilities, a $284,000
charge for impairment of an intangible asset and a $4,000 increase in depreciation expense.
For the years ended April 30, 2009, net cash used in investing activities was $1,150,000
compared to $424,000 provided by investing activities during the year ended April 30, 2008. The
$1,574,000 decrease in cash provided by investing activities was due to the purchase of a one year
certificate of deposit for $1,107,000, a $10,000 increase in the
purchase of intangible asset acquisition costs, and
the purchase of equipment and furniture of $69,000 offset by $471,000
of cash received in the
acquisition of Biomerk during the year ended April 30, 2008. In June 2009, the certificate of
deposit matured and was converted to cash.
For the years ended April 30, 2009 and 2008, net cash provided by financing activities was
$57,000 and $2,489,000, respectively. The $2,432,000 decrease was due to the $2,500,000 in cash
provided by a private placement sale of common stock during the year ended April 30, 2008 offset by
a $24,000 increase in cash provided by the exercise of common stock options and warrants and the
decrease of $44,000 in payment of a loan from an officer of the Company.
The Companys working capital as of April 30, 2009 and 2008 was $1,166,000 and $2,748,000,
respectively.
In May 2009, the Board of Directors approved a stock repurchase agreement with a Board member
to purchase $281,250 worth of the Companys common stock held by the Board member over the next
five quarters providing that the Board member continues his services
under a separate consulting agreement
executed in conjunction with the stock repurchase agreement. Under
the stock repurchase agreement, the Company will
repurchase shares of common stock at the lesser of (a) $0.50 per
share or (b) 50% of the average
volume-weighted closing price of the stock as quoted on the OTC Bulletin Board for the 30 day
trading period ending on the day before the date of each purchase as long as the consulting
agreement remains in effect. The Company also may purchase up to 2,250,000 shares of the common stock
from the Board member at the discretion of the Company, subject to the above commitment and pricing formula.
In May 2008, the Company paid a Board Member $361,000 for accrued salaries earned when the
Companys earnings were insufficient to pay this Board members salary when he was a member of
management.
In June 2009, the Companys Board of Directors authorized management to begin the
process of raising additional capital. There can be no assurance that management will be
successful in raising capital on terms acceptable to the Company, if at all. The Companys ability
to successfully complete a raise of capital will depend on the condition of the capital markets and
the Companys financial condition and prospects. Even if the Company is able to successfully raise
additional capital, such capital could be in the form of debt and could be at high interest rates
and/or require the Company to comply with restrictive covenants that limit financial and business
activities. In addition, even if the Company is able to successfully raise equity capital, this
could dilute the interest of existing shareholders and/or be issued with preferential liquidation,
dividend or voting rights to those currently held by the Companys common stockholders.
17
Table of Contents
Critical Accounting Policies
Revenue Recognition. The Company derives revenue from Personalized Oncology and
Preclinical eValuation services. Personal Oncology Services assist physicians by providing
information that may enhance personalized treatment options for their cancer patients through
access to expert medical information panels and tumor specific data. The Companys Preclinical
eValuation services offer a preclinical tumorgraft platform to pharmaceutical and biotechnology
companies using Biomerk Tumorgraft studies, which have been shown to be predictive of how drugs may
perform in clinical settings. The Company recognizes revenue when the four basic criteria of the
SECs Staff Accounting Bulletin No. 104, Revenue Recognition (SAB 104) are met: 1) a contract
has been entered into with our customers; 2) delivery has occurred or services rendered to our
customers; 3) the fee is fixed and determinable as noted in the contract; and 4) collectability is
reasonably assured, as fees for services are received in full upon execution of the contract. The
Company utilizes a proportional performance revenue recognition model for its Preclinical
eValuation services under which we recognize revenue as performance occurs, based on the relative
outputs of the performance that have occurred up to that point in time under the respective
agreement.
When a Personalized Oncology or Preclinical eValuation arrangement involves multiple elements,
the items included in the arrangement (deliverables) are evaluated pursuant to EITF Issue No.
00-21, Revenue Arrangements with Multiple Deliverables, to determine whether they represent
separate units of accounting. We perform this evaluation at the inception of an arrangement and as
we deliver each item in the arrangement. Generally, we account for a deliverable (or a group of
deliverables) separately if: (1) the delivered item(s) has standalone value to the customer, (2)
there is objective and reliable evidence of the fair value of the undelivered items included in the
arrangement, and (3) if we have given the customer a general right of return relative to the
delivered item(s), delivery or performance of the undelivered item(s) or service(s) is probable and
substantially in our control. All revenue from contracts determined not to have separate units of
accounting is recognized based on consideration of the most substantive delivery factor of all the
elements in the arrangement.
Stock-Based Compensation. The Company has adopted Statement of Financial Accounting
Standards No. 123(R), Share Based Payments, which requires the Company to calculate the fair value of share-based awards
on the date of grant. The Company used the Black-Scholes option pricing model to estimate
fair value. The option pricing model requires the Company to estimate certain key assumptions such
as expected life, volatility, risk free interest rates, and dividend yield to determine the fair
value of share-based awards, based on historical information and management judgment. The Company
amortizes the stock based compensation expense over the period that the awards are expected to
vest, net of estimated forfeiture rates. If the actual forfeitures differ from management
estimates, adjustments to compensation expense are recorded. The Company reports cash flows
resulting from tax deductions in excess of the compensation cost recognized from those options
(excess tax benefits) as financing cash flows.
The Company measures compensation expense for its non-employee
stock-based compensation under EITF Issue No. 96-18,
Accounting for Equity Instruments that are Issued to Other Than
Employees for Acquiring, or in Conjunction with Selling, Goods or
Services (EITF 96-18). The fair value of the option issued
is used to measure the transaction, as this is more reliable than the
fair value of the services received. The fair value is measured at
the value of the Companys common stock on the date that the
commitment for performance by the non-employee consultant has been
reached or the consultants performance is complete.
Income Taxes. The Company accounts for income taxes as prescribed by SFAS No. 109,
Accounting for Income Taxes (SFAS 109). SFAS 109 prescribes the use of the asset and liability
method to compute the differences between the tax basis of assets and liabilities and the related
financial amounts using currently enacted tax laws.
The Company has deferred tax assets, which are subject to periodic recoverability assessments.
Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount
that
more likely than not will be realized. Realization of the deferred tax assets is principally
dependent upon achievement of projected future taxable income offset by deferred tax liabilities.
18
Table of Contents
Item 8. | Financial Statements and Supplementary Data. |
Consolidated balance sheets as of April 30, 2009 and 2009, consolidated statement of
operations, stockholders equity and cash flows for each of the years in the two-year period then
ended April 30, 2009 together with the reports of our independent registered public accounting
firms, are set forth in the F pages of this form 10-K.
Item 9. | Changes In and Disagreements With Accountants on Accounting and Financial Disclosure. |
On March 24, 2009, the Audit Committee of the Board of Directors dismissed its independent
registered public accounting firm, Bagell, Josephs, Levine &
Company L.L.C. and engaged Ernst & Young LLP
as its independent registered public accounting firm for the year ended April 30, 2009. This
determination was approved by the Board of Directors upon the recommendation of its Audit
Committee.
The audit reports of Bagell Josephs, Levine & Company L.L.C. on the consolidated financial statements
of the Company as of and for the fiscal years ended April 30, 2008 and April 30, 2007, did not
contain any adverse opinion or disclaimer opinion, and were not qualified or modified as to
uncertainty, audit scope or accounting
principles.
During the fiscal years ended April 30, 2008 and April 30, 2007, and the subsequent period
through March 23, 2009, there were no disagreements as defined in Item 304 of Regulation S-K with
Bagell, Josephs, Levine & Company L.L.C. on any accounting matter of accounting principles or practices,
financial statement disclosure, or auditing scope or procedure, which disagreements, if not
resolved to Bagell, Joseph, Levine & Company L.L.C. satisfaction, would have caused Bagell Josephs, Levine
& Company L.L.C. to make reference to the subject matter of the disagreement in its reports on the
consolidated financial statements for such year.
ITEM 9A(T). | Controls and Procedures. |
(a) Managements Annual Report on Disclosure Controls and Procedures.
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our reports filed or submitted under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the Securities and Exchange
Commissions rules and forms, and that such information is accumulated and communicated to
management, including the Chief Executive Officer and Chief Financial Officer, as appropriate to
allow timely decisions regarding required disclosure. In designing and evaluating the disclosure
controls and procedures, management recognized that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving the desired control
objectives and management was required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
As of the end of the period covered by this report, management, under the supervision of the
Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the design and
operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e)
under the Securities Exchange Act of 1934, as amended. Based upon that evaluation, the Chief
Executive Officer and Chief Financial Officer concluded that, as of the end of such period, the
disclosure controls and procedures were
not effective at a level of reasonable assurance to ensure that the information required to be
disclosed in the reports we file and submit under the Exchange Act is accumulated and communicated
to management and is recorded, processed, summarized and reported in such filings as and when
required.
19
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Management of the Company is responsible for establishing and maintaining adequate disclosure
controls and procedures and for the assessment of the effectiveness of disclosure controls and
procedures. The Companys disclosure controls and procedures is a process designed under the
supervision of the Companys Principal Executive Officer and
Chief Financial Officer to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of the
consolidated financial statements in accordance with United States generally accepted accounting
principles (U.S. GAAP).
Our
Principal Executive Officer and Chief Financial Officer have concluded that during the
period covered by this report, such internal control over financial reporting were not effective to
detect the inappropriate application of U.S. GAAP, as more fully described below. This was due to
deficiencies that existed in the design or operation of our internal control over financial
reporting that adversely affected our disclosure controls and that are considered material
weaknesses. The Public Company Accounting Oversight Board has defined a material weakness as a
deficiency, or combination of deficiencies, in internal control over financial reporting (ICFR)
such that there is a reasonable possibility that a material misstatement of the companys annual or
interim financial statements will not be prevented or detected on a timely basis by the companys
ICFR.
The material weaknesses identified in our internal controls and disclosure controls related
to:
The Companys staffing. Our auditors identified a material weakness which consisted primarily
of inadequate staffing and supervision that could lead to the
untimely identification and resolution of accounting and disclosure
matters and failure to perform timely and effective reviews.
The
Companys application of U.S. GAAP to stock-based compensation. With respect to
our stock-based compensation calculations, the Company improperly determined the measurement dates
for grants of stock-based compensation to non-employees of the
Company. In addition, we did not correctly account for modifications in employment status for
stock-based compensation awards and we misclassified the fair value of the unvested
portion of stock base compensation expense for non-employee awards as
a contra equity account, called prepaid consulting, within stockholders
equity. As a result of this accounting error, the Company amended its
Form 10-KSB as of April 30, 2008 and its Form 10-Qs as of
July 31, 2008, October 31, 2008 and January 31, 2009.
The Companys accounting for revenue recognition and prepaid costs under the personalized
oncology development services agreement. Previously, we recognized vaccine revenues on a
performance revenue recognition method. Under this approach, the Company recognized a percentage of
the contract consideration of the gross contract value upon implantation of a patients tumor into
immune deficient mice and the remaining deferred revenue upon delivery of the tumor to a separate
third party who performs other services for the Company under the
vaccine program. In addition, the
Company expensed 100% of refundable upfront costs paid to third party
contractors for services to be delivered at a future date. After reviewing all of the relevant accounting literature related
to revenue recognition, we determined that revenue should be
recognized under the agreement only when the final deliverable in the
agreement has been delivered. Under the agreement, the final
deliverable is the earlier of the delivery of the cancer vaccine or the expiration of the agreement
term. With respect to the upfront costs that the Company pays to the other contractors
participating in the program, it was determined that these costs should be capitalized as
refundable advance payments and recognized as the services are
performed. As a result of this accounting error, the Company amended
its Form 10-Q as of January 31, 2009.
The
Companys financial statement close process. The Company
determined that there was a lack of formalized and detailed management level reviews during the financial
statement close process and a lack of sufficient technical accounting resources to adequately
perform certain significant non-routine financial reporting processes
that resulted in audit adjustments impacting several accounts.
Management has determined
that the Companys financial statement close process should
be re-evaluated to ensure (i) that all significant account balances, including judgmental areas,
affected by the Companys non-routine and estimation processes are reviewed for appropriate
accounting support by management as part of the Companys financial statement close process, and
(ii) that reviews of significant account balance analyses and SEC or other regulatory filings are
conducted by technically proficient Company personnel in a timely manner.
20
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(b) Changes in Internal Controls.
In order to correct the specifically identified material weaknesses, we are taking the following
steps, among others:
| evaluating the skills and depth of our technical accounting staff to determine if
our accounting resources are sufficient to perform our financial reporting processes
adequately and to identify the additional resources, if any, that may be required to
perform our financial reporting processes. The Company recently hired an assistant
controller to handle the day-today accounting functions of the Company. |
||
| strengthening the controls around those financial reporting processes that we
determined are material weaknesses or internal control deficiencies; |
||
| revising our financial statement close process to include more robust reviews of
all account balances and non-recurring or infrequent items and to require a more
thorough evaluation of compliance with U.S. generally accepted accounting principles
prior to finalizing our financial statements |
||
| licensing of a stock-based
compensation accounting software to assist in the proper
accounting and reporting of stock-based compensation. |
We believe that the steps we are taking to strengthen our system of internal controls and our
disclosure controls and procedures will be adequate to provide reasonable assurance that the
objectives of these control systems will be met and that these material weaknesses will be
remediated in fiscal 2010. However, because of the inherent limitations in all control systems, no
evaluation of controls can provide absolute assurance that all control issues, if any, within the
Company have been detected. These inherent limitations include the realities that judgments in
decision-making can be faulty, and that breakdowns can occur because of simple error or mistake.
The Company will become subject to Sarbanes-Oxley Act of 2002 Section 404: Assessment of
Internal Control (Section 404) for the fiscal year
ended April 30, 2010. Under Section 404, management and the external auditors will be required to report on the adequacy of the Companys
internal control over financial reporting.
This annual report does not include an attestation report of the Companys independent
registered public accounting firm regarding internal control over financial reporting.
Managements report was not subject to attestation by the Companys independent registered public
accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit
the Company to provide only managements report in this annual report.
Item 9B. | Other Information. |
None.
21
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PART III
Item 10. | Directors, Executive Officers and Corporate Governance. |
Directors and Executive Officers
The directors and executive officers of the Company as of April 30, 2009 are as follows:
Name
|
Position(s) Presently Held | |
David Sidransky, M.D.
|
Chairman | |
Douglas D. Burkett, Ph.D.
|
Principal Executive Officer, President | |
Mark R. Schonau
|
Chief Financial Officer | |
James M. Martell
|
Director | |
Abba David Poliakoff
|
Director | |
Ana I. Stancic
|
Director |
David Sidransky, M.D., age 49, has served as Chairman of the Company since October 2007 and
Director since August 2007. Dr. Sidransky is the Director of the Head and Neck Cancer Research
Division at Johns Hopkins University School of Medicine and is a Professor of Oncology,
Otolaryngology-Head and Neck Surgery, Cellular & Molecular Medicine, Urology, Genetics, and
Pathology at Johns Hopkins University and Hospital. Dr. Sidransky is one of the most highly cited
researchers in clinical and medical journals in the world, in the field of oncology during the past
decade, with over 400 peer-reviewed publications. He has contributed more than 60 cancer reviews
and chapters. Dr. Sidransky is a founder of a number of biotechnology companies and holds numerous
biotechnology patents. He has served as Vice Chairman of the Board of Directors of ImClone and was,
until the merger with Eli Lilly, a director of ImClone Systems, Inc., a global biopharmaceutical
company committed to advancing oncology care, and Chairman of Alfacell Corporation. Dr. Sidransky
is serving and has served on scientific advisory boards of MedImmune, Roche, Amgen and Veridex,
LLC. (a Johnson & Johnson diagnostic company), among others Dr. Sidransky served as Director
(2005-2008) of American Association for Cancer Research (AACR). He was the chairperson of the
first (September 2006) and the second (September 2007) AACR International Conference on Molecular
Diagnostics in Cancer Therapeutic Development: Maximizing Opportunities for Individualized
Treatment. Dr. Sidransky is the recipient of many awards and honors, including the 1997 Sarstedt
International Prize from the German Society of Clinical Chemistry, the 1998 Alton Ochsner Award
Relating Smoking and Health by the American College of Chest Physicians and the 2004 Hinda and
Richard Rosenthal Award from the American Association of Cancer Research. Dr. Sidransky is
certified in Internal Medicine and Medical Oncology by the American Board of Medicine. Dr.
Sidransky received his B.A. from Brandeis University and his M.D. from the Baylor College of
Medicine.
Douglas D. Burkett, Ph.D., age 45, has served as President of the Company since March 2008.
Dr. Burkett has served from July 2007 to March 2008 as executive consultant to assist the Company
in establishing and executing its strategic and business plan prior to becoming President. Dr.
Burkett served as Chairman, Chief Executive Officer and President of Zila, Inc. (Zila) from 2002
to 2007 and led a strategic transformation of Zila into a cancer detection company. He led the FDA
approval, launch and growth of ViziLite Plus, an oral cancer screening product, and the
establishment of the first insurance reimbursement for oral cancer screening products in the United
States. Dr. Burkett held several senior positions at Zila from 1995 to 2002; he was responsible
for Zilas technical operations, its manufacturing subsidiary, its Pharmaceuticals business and
business development. Early in his career he led the building of a research and development
laboratory, pharmaceutical manufacturing facility, compliance unit and regulatory team that
achieved a rare no deficiency FDA pre approval inspection. Dr. Burkett is the lead inventor in
numerous issued and pending patents involving novel cancer detection methods and drugs. He is
quoted in leading publications including the Wall Street Journal regarding his pioneering efforts
in early oral cancer detection. Prior to joining Zila, Dr. Burkett was employed at the Arizona
State University
Cancer Research Institute where he collaborated with the National Cancer Institute in synthesizing
and performing studies for potential cancer treatment drugs. Prior to his tenure at ASU he
researched, developed and manufactured pharmaceutical drugs for a private pharmaceutical company.
Dr. Burkett received a B.S. in Chemistry from Missouri Western State College in 1987, and a Ph.D.
in Organic Chemistry from Arizona State University in 1994.
22
Table of Contents
Mark R. Schonau, Age 52 has served as Chief Financial Officer since January 2009. Mr. Schonau
brings more than twenty-five years of leadership in financial and operations management to Champions.
Mr. Schonau previously served as Chief Financial Officer for Insys Therapeutics a development stage
biopharmaceutical company focused on discovering, developing, and commercializing products to
address cancer-related pain and CINV. Prior to that, Mr. Schonau served as CFO of Axway, Inc., a
leading global provider of collaborative business solutions from January 2006 through August 2007.
From January 2001 to January 2006, Mr. Schonau served as CFO and Senior Vice President of
Administration for Cyclone Commerce, a business-to-business systems provider that was acquired by
Axway in 2006. Upon Cyclones acquisition by Axway, Mr. Schonau became the North American Chief
Financial Officer of the surviving entity. From 1988 to 2000, Mr. Schonau also served as CFO for
two public companies; Viasoft (NASDQ VIAS) and CyCare (NYSE CYS). Mr. Schonau was also
employed by the accounting firm of Ernst & Young LLP from January 1981 to May 1988. He is a member
of the Arizona and American Institutes of Certified Public Accountants and currently sits on the
board of directors of the Arizona Technology Foundation. Mr. Schonau received a Bachelors degree
in Accounting from Arizona State University.
James M. Martell, age 62, a Director of the Company, served as Chief Administrative Officer of
the Company from March 2008 until May 2009 when he resigned as Chief Administrative Officer and
entered into a consulting agreement with the Company. Mr. Martell founded the Company in 1985.
Since then he has served in various capacities as Chairman, President and CEO until 2007 when the
Company changed its business direction to focus on biotechnology, and then served as President and
CEO of until March, 2008. Mr. Martell currently administers and oversees the Companys medical
information panels. He was a partner from 1983 to 1987 in Tomar Associates, a consulting company
specializing in European-American joint ventures, venture capital financing, technology transfer,
and corporate finance. From 1981 to 1983, Mr. Martell was a partner in International Group, a
company involved in promoting national and international business development. He held various
administrative positions from 1973 to 1981 with the U.S. Department of Energy. Mr. Martell received
a Bachelor of Science degree in Chemistry in 1968 and Master of Science degree in Geochemistry in
1973, from George Washington University.
Abba David Poliakoff, age 57, has served as Director of the Company since March 2008. Mr.
Poliakoff is a member of the law firm of Gordon, Feinblatt, Rothman, Hoffberger & Hollander, LLC,
in Baltimore, Maryland, is a member of the Maryland State Bar Associations Business Law Section
and former Chair of its Committee on Securities. Formerly, he was a member of the Business
Regulations Article Review Committee of the Committee to Revise the Maryland Annotated Code. Mr.
Poliakoff is a member of the Board of Directors of the Greater Baltimore Technology Council (GBTC)
and former Chair of its Legislative Committee. He is a former Chair of the Maryland Business &
Technology Coalition, member of the Technology Council of Maryland, and member of the MIT
Enterprise Forum. Mr. Poliakoff is currently the Chairman of the Maryland Israel Development
Center, a joint venture between the State of Maryland Department of Business and Economic
Development and the State of Israel Ministry of Industry and Trade. He is also a co-founder and on
the Board of Directors of the Maryland Middle Eastern Chamber of Commerce. Governor Martin J.
OMalley of Maryland appointed Mr. Poliakoff in 2009 to the Governors International Advisory
Council on International Commerce and Trade. He was previously appointed by Maryland Governor
Robert C. Ehrlich, Jr. to the Governors Transition Committee. In his community work, he is on the
Board of Directors of the Baltimore Jewish Council, and on the Board of Directors of The
Associated: Jewish Community Federation of Baltimore. Mr. Poliakoff is a former President for the
Maryland Region of the National Jewish Commission on Law and Public Affairs (COLPA), and a founder
and past president of the Jewish Arbitration and Mediation Board of Baltimore.
23
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Ana I. Stancic, age 52, has served as director of the Company since March 2008. Ms. Stancic is
a financial executive with over 20 years of experience in the life science
industry. Ms. Stancic has extensive experience in corporate finance, strategic planning, external
reporting, mergers and acquisitions, treasury, risk management, investor relations, and
corporate governance. Until July 2009, Ms. Stancic served as Chief Financial Officer of
Aureon Laboratories Incorporated (Aureon), an oncology diagnostic company dedicated to enabling
the advancement of predictive and personalized cancer treatment by performing diagnostic reference
laboratory and clinical research services. Prior to joining Aureon, Ms. Stancic was Executive Vice
President and Chief Financial Officer at OMRIX Biopharmaceuticals, Inc. Before joining OMRIX, Ms.
Stancic served as Senior Vice President, Finance at ImClone Systems, Inc. (ImClone), a global
biopharmaceutical company committed to advancing oncology care, where she was responsible for
ImClones finance department, information technology and internal audit. Ms. Stancic joined ImClone
as Vice President, Controller and Chief Accounting Officer in 2004. Prior to joining ImClone, she
was Vice President and Controller at Savient Pharmaceuticals, Inc. from 2003 to February, 2004. Ms.
Stancic was Vice President and Chief Accounting Officer at Ogden Corporation from 1999 to 2002 and
Regional Chief Financial Officer at OmniCare, Inc. from 1997 to 1999. Ms. Stancic began her career
in 1985 at PricewaterhouseCoopers in the Assurance practice where she audited international and
national companies in the pharmaceutical and services industries. Ms. Stancic is a Certified Public
Accountant and holds an M.B.A. degree from Columbia Business School.
The term of office of each director is until the next annual election of Directors and until a
successor is elected and qualified or until the Directors earlier death, resignation or removal.
Officers are appointed by the Board of Directors and serve at the discretion of the Board. There is
no family relationship between or among any of the Companys directors or officers.
Board Committees
The Board of Directors has appointed an Audit Committee, a Compensation Committee, and a
Nominating and Corporate Governance Committee and has adopted charters for each of these
committees. The Board of Directors has determined that Ana Stancic qualifies as the Audit
Committees financial expert. The members of the committees are:
Nominating and Corporate Governance Committee
David Sidransky, Chair
David Sidransky, Chair
Abba David Poliakoff
Ana Stancic
Ana Stancic
Compensation Committee
Abba David Poliakoff, Chair
Abba David Poliakoff, Chair
David Sidransky
Ana Stancic
Ana Stancic
Audit Committee
Ana Stancic, Chair
Ana Stancic, Chair
Abba David Poliakoff
David Sidransky
David Sidransky
Code of Ethics
The Company has a Code of Ethics that applies to all Company employees, including the
President and Chief Financial Officer, as well as members of the Board of Directors. The
Companys Code of Ethics is included as filed as Exhibit 14 to this Annual Report on Form 10-K.
Compliance with Section 16(a) Beneficial Ownership Reporting Compliance
Section 16(a) of the Exchange Act, as amended, requires the Companys executive officers,
directors and persons who beneficially own more than 10% of the Companys common stock to file
reports
of their beneficial ownership and changes in ownership (Forms 3, 4 and 5, and any amendment
thereto) with the SEC executive officers, directors, and greater-than-ten percent holders are
required to furnish the Company with copies of all Section 16(a) forms they file. During the
fiscal year ended April 30, 2009, the following report was not timely filed: a Form 3 filed by Mark
Schonau on February 10, 2009.
24
Table of Contents
Item 11. | Executive Compensation. |
The following sets forth information for the two most recently completed fiscal years
concerning the compensation of (i) the Companys principle executive officer and (ii) all other
executive officers who earned in excess of $100,000 in total compensation in the fiscal year ended
April 30, 2009.
SUMMARY COMPENSATION TABLE
Option | ||||||||||||||||
Name and Principal Position | Year | Salary ($) | Awards ($) | Total ($) | ||||||||||||
Dr. Douglas D. Burkett, Principal
Executive Officer |
2009 | 225,000 | | 225,000 | ||||||||||||
2008 | 18,750 | (1) | 389,945 | 408,695 | ||||||||||||
James Martell, Chief Administrative
Officer |
2009 | 185,000 | 185,000 | |||||||||||||
2008 | 113,416 | 113,416 | ||||||||||||||
Mark R. Schonau, Chief Financial Officer |
2009 | 53,958 | (2) | 212,616 | 266,574 | |||||||||||
Durwood Settles, Chief Financial Officer |
2009 | 100,000 | 100,000 |
(1) | Salary following March 27, 2008, date of employment agreement. |
|
(2) | Salary following January 19, 2009, date of employment agreement. |
The Board of Directors has the right to change and increase the compensation of executive
officers at any time.
Dr. Douglas D. Burkett, Principle Executive Officer
The Company entered into an employment agreement dated March 27, 2008 with Dr. Burkett to
serve as President. The term of the agreement commenced on March 31, 2008 and extends for a
two-year period, renewing automatically for successive one year periods unless notice of
non-renewal is given by the Company or Dr. Burkett. Dr. Burketts compensation includes a salary of
$225,000 per year, participation in Company employee benefit plans and reconfirmation of an option
previously granted on October 10, 2007 to acquire 500,000 shares of common stock at an exercise
price of $0.75 per share, the market price of the common stock on the date the option was granted.
The options to purchase shares vest at the rate of 166,665 shares on the first anniversary of the
grant date, 166,665 shares on the second anniversary of the grant date and 166,670 shares on the
third anniversary of the grant date. All vested options will be exercisable over a five-year period
expiring on the fifth anniversary of the grant date, provided that the options will terminate upon
a material breach by the executive of the employment agreement. The agreement further provides that
if the Company terminates Dr. Burketts employment without cause, the Company shall pay him
severance equal to four months salary and his options shall immediately vest.
25
Table of Contents
James Martell, Chief Administrative Officer
The Company entered into an employment agreement dated March 31, 2008 with James Martell to
serve as Chief Administrative Officer. The term of the agreement commenced on March 31, 2008 and
extends for a one-year period, renewing automatically for successive one year periods unless notice
of non-renewal is given by the Company or Mr. Martell. Mr. Martells compensation includes a salary
of $185,000 per year and participation in Company employee benefit plans. The agreement further
provides that if the Company terminates him without cause, the Company shall pay him severance
equal to three months salary. In May 2008, the Company paid Mr. Martell $361,000 for past
services rendered. In May 2009, Mr. Martell resigned as Chief Administrative Officer and became a
consultant to the Company. Under the
consulting agreement, Mr. Martell will be compensated at the rate of $100,000 annually. The
consulting agreement terminates in May 2011. Either party may terminate the agreement upon ninety
days written notice. In May 2009, the Company entered into a Board approved Stock Repurchase
Agreement with James Martell, a Board member, to purchase $281,250 of the Companys Common stock
held by Mr. Martell over the next five quarters providing that Mr. Martell continues his consulting
agreement. Under the agreement, the Company will repurchase stock at the lesser price of (a) $0.50
or (b) 50% of the average volume-weighted closing price of the stock as quoted on the OTC Bulletin
Board for the 30 day trading period ending on the day before the date of each purchase. The
Company may purchase up to 2,250,000 shares of Mr Martells common stock at the discretion of the
Company subject to the above commitment and pricing formula.
Mark R. Schonau, Chief Financial Officer
The Company entered into an employment agreement dated January 5, 2009 with Mr. Schonau to
serve as Chief Financial Officer. The term of the agreement commenced on January 19, 2009 and is
at-will. Mr. Schonaus compensation includes a salary of $185,000 per annum, participation in
Company employee benefit plans and an option to purchase 233,000 shares of the Companys common
stock at an exercise price of $1.18 per share, the market price of the common stock on the date the
options were approved by the Companys Board of Directors. The options to purchase shares vest at
the rate of 77,666 shares on the first anniversary of the grant date, 77,667 shares on the second
anniversary of the grant date and 77,667 on the third anniversary of the grant date. All vested
options will be exercisable over a seven-year period beginning on the third anniversary of the
grant date. The agreement further provides that if the Company terminates the executives
employment without cause, the Company shall pay the executive severance equal to three months
salary.
Durwood Settles, Chief Financial Officer (former)
On January 15, 2007, the Company issued options for 50,000 shares of restricted stock to
Durwood Settles, Director of the Company, exercisable over a five year period, based on a fair
value exercise price on the date of issuance of $0.17, exercisable through January 15, 2012, and
vesting one year from the date of issuance. Mr. Settles became the Companys controller on January
19, 2009 and left the Company effective July 1, 2009.
The following table sets forth, for each of the executive officers named in the Summary
Compensation Table, information with respect to unexercised options as of the Companys fiscal year
ended April 30, 2009:
Number of | Number of | |||||||||||||||
Securities | Securities | |||||||||||||||
Underlying | Underlying | |||||||||||||||
Unexercised | Unexercised | Option | Option | |||||||||||||
Options (#) | Options (#) | Exercise | Expiration | |||||||||||||
Name | Exercisable | Un-exercisable | Price ($) | Date | ||||||||||||
Douglas D. Burkett
(1) |
166,666 | 333,334 | 0.75 | 10/10/2012 | ||||||||||||
Mark R. Schonau (2) |
| 233,333 | 1.18 | 2/23/2019 | ||||||||||||
James Martell |
N/A | N/A | N/A | N/A | ||||||||||||
Durwood Settles |
50,000 | | 0.17 | 1/15/2012 |
(1) | These options to purchase shares vest at the rate of 166,665 shares on each of the first three
anniversaries of the October 10, 2007 grant date. All vested options will be exercisable over a
five-year period expiring on the fifth anniversary of the grant date, provided that the options
will terminate upon a material breach by Dr. Burkett of his employment agreement. The options shall
immediately vest if the Company terminates Dr. Burketts employment without cause. |
|
(2) | These options to purchase shares vest at the rate of 77,777 shares on each of the first three
anniversaries of the February 23, 2009 grant date. All vested options will be exercisable over a
ten year period expiring on the tenth anniversary of the grant date. |
26
Table of Contents
DIRECTOR COMPENSATION
In the fiscal year ended April 30, 2008, the Board of Directors agreed to a Directors
compensation plan whereby non-employee directors will receive options to purchase 50,000 shares
upon their initial appointment as a director. In addition, the Chairman of the Board will receive
options to purchase 50,000 shares. Each director is entitled to receive options to purchase 20,000
shares annually upon their reelection or as of the annual meeting date. All options have a term of
five years, vest equally over three years at the rate of one-third each year, and have an exercise
price equal to the fair market value of the stock on the date the option is granted. Under the
plan, on March 31, 2008 Mr. Poliakoff and Ms. Stancic, both appointed as independent directors of
the Company, were each granted options to purchase 50,000 shares, and Dr. Sidransky was granted
options to purchase 40,000 shares, all at a price of $1.15 per share, the market price on the date
of grant, as their initial option grant.
The following table summarizes the compensation paid to directors for the fiscal year ended
April 30, 2009 and 2008:
2009 | 2008 | |||||||
Board Member | Option Awards ($) | Option Awards ($) | ||||||
David Sidransky |
$ | | $ | 28,342 | ||||
Abba David Poliakoff |
$ | | $ | 35,427 | ||||
Ana Stancic |
$ | | $ | 35,427 | ||||
James Martell |
$ | | $ | |
The above option award values were calculated using the Black-Scholes valuation method (see
Note 3 to the Consolidated Financial Statements included herein).
Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters. |
As of August 10, 2009 the following were persons known to the Company to own beneficially more
than 5% of the Companys outstanding Common Stock:
Name and Address of | Common Stock | Percent | ||||||
Beneficial Owner | Beneficially Owned (1) | of Class | ||||||
Dr. David Sidransky 1550 Orleans Street Baltimore, MD 21231 |
10,613,333 | 32.2 | ||||||
James M.
Martell 1400 N. 14th Street Arlington, VA 22209 |
7,535,501 | 22.8 | ||||||
Dr. Manuel Hildalgo 206 Cross Street Baltimore, MD 21230 |
2,729,167 | 8.1 |
(1) | Beneficial ownership includes shares for which an individual, directly or
indirectly, has or shares, or has the right within 60 days to have or share, voting or investment
power or both. Beneficial ownership as reported in the above table has been determined in
accordance with Rule 13d-3 of the Exchange Act. |
27
Table of Contents
As of April 30, 2009, the common stock ownership by officers and directors of the Company and
all officers and directors as a group was as follows:
Common Stock | Percentage | |||||||||||
Name of Beneficial Owner | Title | Beneficially Owned (1) | of Class | |||||||||
Dr. David Sidransky |
Chairman | 10,613,333 | 32.20 | |||||||||
Douglas D. Burkett, Ph.D. |
Principal Executive Officer | 170,666 | 0.01 | |||||||||
James M. Martell |
Director | 7,848,001 | 23.40 | |||||||||
Abba David Poliakoff |
Director | 416,666 | 1.30 | |||||||||
Ana I. Stancic |
Director | | | |||||||||
All Officers and
Directors as a
group |
19,048,666 | 56.91 | ||||||||||
(1) | Beneficial ownership includes shares for which an individual, directly or
indirectly, has or shares, or has the right within 60 days to have or share, voting or investment
power or both. Beneficial ownership as reported in the above table has been determined in
accordance with Rule 13d-3 of the Exchange Act. |
Equity Compensation Plan Information
The Company has granted options to individual employees, directors, and consultants pursuant
to individual compensation arrangements under a 2008 Equity Incentive Plan that has not yet been
approved by shareholders. The following table provides information, as of April 30, 2009, with
respect to all these compensation arrangements under which shares are authorized for issuance.
Number of | Number of securities | |||||||||||
securities to be | remaining available for | |||||||||||
issued upon | Weighted-average | future issuance under | ||||||||||
exercise of | exercise price of | equity compensation | ||||||||||
outstanding | outstanding | plans (excluding | ||||||||||
options, warrants | options, warrants | securities reflected in | ||||||||||
and rights | and rights | column (a) | ||||||||||
Plan Category | (a) | (b) | (c) | |||||||||
Equity compensation
plans approved by
security holders |
| | | |||||||||
Equity compensation
plans not approved
by security holders |
2,498,333 | $ | 0.76 | | ||||||||
Total |
2,498,333 | $ | 0.76 | |||||||||
Item 13. | Certain Relationships and Related Transactions. |
During 2009 we paid our former CEO approximately $361,000 for accrued salaries payable to him
outstanding as of April 30, 2008. No amounts were outstanding as of April 30, 2009.
During the year ended April 30, 2009, the Company paid our Chairman, David Sidransky, $105,000
for consulting services.
28
Table of Contents
Item 14. | Principal Accountant Fees and Services. |
The following is a summary of the fees billed to the Company by its principal accountants
during the fiscal years ended April 30, 2009, and April 30, 2008:
Fee Category | 2009 | 2008 | ||||||
Audit and related fees |
$ | 28,000 | $ | 25,000 | ||||
Tax fees |
5,000 | | ||||||
All other fees |
10,000 | 9,000 | ||||||
Total fees |
$ | 43,000 | $ | 34,000 | ||||
Audit and related fees: Consists of fees for professional services rendered by our principal
accountants for the audit of the annual financial statements fees for assurance and related
services by our principal accountants that are reasonably related to the performance of the audit
or review of financial statements.
Tax fees: Consists of fees for professional services rendered by our principal accountants
for tax compliance, tax advice and tax planning.
All other fees: Consists of fees for products and services provided by our principal
accountants, other than the services reported under Audit and related fees, and Tax fees above.
The prior approval of the Board of Directors is required for the engagement of our auditors to
perform any non-audit services for us. Other than de minimis services incidental to audit
services, non-audit services shall generally be limited to tax services such as advice and planning
and financial due diligence services. All fees for such non-audit services must be approved by the
Board of Directors, except to the extent otherwise permitted by applicable SEC regulations.
29
Table of Contents
PART
IV
Item 15. | Exhibits and Financial Statement Schedules. |
(a) | The following documents are filed as part of this report: |
|
1. | Financial Statements. |
|
The following financial statements of Champions Biotechnology and Reports of Independent
Registered Public Accounting Firms are presented in the F pages of this report: |
||
Reports of Independent Registered Public Accounting Firms. |
||
Consolidated Balance Sheets April 30, 2009 and 2008. |
||
Consolidated Statements of Operations Each of the years in the two-year period ended April 30, 2009. |
||
Consolidated Statements of Stockholders Equity Each of the years in the two-year period ended April
30, 2009. |
||
Consolidated Statements of Cash Flows Each of the years in the two-year period ended April 30, 2009. |
||
Notes to Consolidated Financial Statements. |
||
2. | Financial statement schedules have been ommited since the required
information is not appropriate or is not present in amounts sufficient
to require submission after scheduled, or because of the information
is included in the financial statements and notes thereto. |
|
3. | All management contracts and compensatory plans and arrangements are
specifically identified on the attached Exhibit Index. |
|
(b) | Exhibits: |
Exhibits No. | |||||
2.1 | Biomerk Agreement and Plan of Merger (incorporated by reference to Exhibit 10.1 of Form 8-K filed on May 24, 2007) |
||||
3.1 | Articles of Incorporation* |
||||
3.2 | Bylaws, as amended* |
||||
10.1 | Employment
Agreement dated March 27, 2008 between the Company and Douglas
D. Burkett (incorporated by reference to Exhibit 10.1 of the
April 30, 2008 Form 10-KSB) |
||||
10.2 | Employment
Agreement dated March 31, 2008 between the Company and James Martell (incorporated by reference to Exhibit 10.2 of the
April 30, 2008 Form 10-KSB) |
||||
10.3 | Employment Agreement dated March 26, 2008 between the Company and Durwood C. Settles (incorporated by reference to Exhibit 10.3 of the
April 30, 2008 Form 10-KSB) |
||||
10.4 | Employment Agreement dated January 5, 2009 between the Company and Mark R. Schonau* |
||||
10.5 | Consulting Agreement dated May 18, 2009 between the Company and James Martell.* |
||||
10.6 | Stock Repurchase Agreement dated May 18, 2009 between the Company and James Martell.* |
||||
10.7 | Lease of Maryland facility (incorporated by reference to Exhibit 10.1 of January 31, 2009 Form 10-Q) |
||||
10.8 | Agreement re: Patent Application acquisition (incorporated by reference to Exhibit 10 of Form 8-K filed on February 16, 2007) |
||||
14 | Code of Ethics (incorporated by reference to Exhibit 14 of the
April 30, 2008 Form 10-KSB) |
||||
21 | Subsidiaries of the Registrant* |
||||
31.1 | Rule 13a-14(a)/15d-14(a)
Certification of President and Principle Executive Officer* |
||||
31.2 | Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer* |
||||
32.1 | Section 1350 Certifications* |
* | Filed herewith |
(c) | Financial Statements and Schedules See Item 15(a)(1) and Item 15(a)(2) above. |
30
Table of Contents
SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the registrant
caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
CHAMPIONS BIOTECHNOLOGY, INC. |
||||
By: | /s/ Douglas D. Burkett | |||
Douglas D. Burkett | ||||
President and Principal Executive Officer | ||||
Date: August 26, 2009 |
In accordance with the Exchange Act, this report has been signed below by the
following persons on behalf of the registrant and in the capacities and on the
dates indicated.
By: | /s/ Mark R. Schonau | |||
Mark R. Schonau | ||||
Chief Financial Officer | ||||
Date: August 26, 2009 | ||||
By: | /s/ David Sidransky | |||
Chairman | ||||
Director | ||||
Date: August 26, 2009 | ||||
By: | /s/ James Martell | |||
Director | ||||
Date: August 26, 2009 | ||||
By: | /s/ Abba Poliakoff | |||
Director | ||||
Date: August 26, 2009 | ||||
By: | /s/ Ana Stancic | |||
Director | ||||
Date: August 26, 2009 |
31
CHAMPIONS
BIOTECHNOLOGY, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
APRIL 30, 2009 AND 2008
Page | ||||
CONSOLIDATED FINANCIAL STATEMENTS: |
||||
F-2 | ||||
F-3 | ||||
F-4 | ||||
F-5 | ||||
F-6 | ||||
F-7 | ||||
F-8 F-18 | ||||
F-1
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Stockholders of
Champions Biotechnology, Inc.
Champions Biotechnology, Inc.
We have audited the accompanying consolidated balance sheet of Champions Biotechnology, Inc. (the Company), as of
April 30, 2009, and the related consolidated statements of operations, stockholders equity, and cash flows for the
year then ended. The financial statements are the responsibility of the Companys 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. We were not engaged to perform an audit of the Companys
internal control over financial reporting. Our audit included consideration of internal control over financial
reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose
of expressing an opinion on the effectiveness of the Companys internal control over financial reporting.
Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the
amounts and disclosures in the financial statements, 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 consolidated financial statements referred to above present fairly, in all material respects, the
consolidated financial position of Champions Biotechnology, Inc. at April 30, 2009 and the consolidated results of its
operations and its cash flows for the year then ended in conformity with U.S. generally accepted accounting
principles.
The
accompanying consolidated financial statements have been prepared
assuming that the Company will continue as a going concern. As more
fully described in Note 1, the Companys recurring losses from operations raise
substantial doubt about its ability to continue as a going concern. Managements plans as to these matters also are
described in Note 1. The consolidated financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
/s/ Ernst & Young LLP
Phoenix, Arizona
August 26, 2009
August 26, 2009
F-2
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Stockholders
Champions Biotechnology, Inc.
Champions Biotechnology, Inc.
We have audited the accompanying consolidated balance sheet of Champions
Biotechnology, Inc., as of April 30, 2008, and the related
consolidated statements of operations, stockholders equity and cash flows for the year ended April 30, 2008. Champions
Biotechnology, Inc.s management is responsible for these financial statements.
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. The company is not
required to have, nor were we engaged to perform, an audit of its internal
control over financial reporting. Our audit included consideration of internal
control over financial reporting as a basis for designing audit procedures that
are appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the companys internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements, 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 consolidated financial statements referred to above present
fairly, in all material respects, the financial position of Champions
Biotechnology, Inc. as of April 30, 2008, and the results of its
operations and its cash flows for the year ended April 30, 2008 in conformity with accounting principles generally
accepted in the United States of America.
/s/ BAGELL, JOSEPHS, LEVINE & COMPANY, L.L.C.
Marlton, NJ 08053
July 28, 2008 (August 13, 2009 as to Note 5)
Marlton, NJ 08053
July 28, 2008 (August 13, 2009 as to Note 5)
F-3
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
CONSOLIDATED BALANCE SHEETS
April 30, | ||||||||
2009 | 2008 | |||||||
ASSETS |
||||||||
CURRENT ASSETS |
||||||||
Cash and cash equivalents |
$ | 1,728,000 | $ | 3,709,000 | ||||
Short term investments |
1,017,000 | | ||||||
Prepaid expenses, deposits, and other receivables |
1,125,000 | 53,000 | ||||||
Total current assets |
3,870,000 | 3,762,000 | ||||||
Property and equipment, net |
81,000 | | ||||||
Intangible assets |
| 227,000 | ||||||
Goodwill |
669,000 | 662,000 | ||||||
TOTAL ASSETS |
$ | 4,620,000 | $ | 4,651,000 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
CURRENT LIABILITIES |
||||||||
Accounts payable |
$ | 1,414,000 | $ | 113,000 | ||||
Accrued liabilities |
67,000 | 35,000 | ||||||
Deferred revenue |
1,223,000 | 505,000 | ||||||
Accrued salary due to officer |
| 361,000 | ||||||
Total current liabilities |
2,704,000 | 1,014,000 | ||||||
COMMITMENTS AND CONTINGENCIES |
||||||||
STOCKHOLDERS EQUITY |
||||||||
Preferred stock, $10 par value; 56,075 shares authorized;
no shares issued or outstanding |
| | ||||||
Common stock, $.001 par value; 50,000,000 shares authorized;
33,579,000 and 33,338,000 issued at April 30, 2009 and 2008, respectively,
and 32,989,000 and 33,248,000 shares outstanding, respectively |
34,000 | 33,000 | ||||||
Treasury stock, at cost, 590,000 and 90,000 shares, respectively |
(1,000 | ) | | |||||
Additional paid-in capital |
11,640,000 | 11,119,000 | ||||||
Accumulated deficit |
(9,757,000 | ) | (7,515,000 | ) | ||||
Total stockholders equity |
1,916,000 | 3,637,000 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY |
$ | 4,620,000 | $ | 4,651,000 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
F-4
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
Year Ended April 30, | ||||||||
2009 | 2008 | |||||||
OPERATING REVENUE |
||||||||
Personalized oncology services |
$ | 3,278,000 | $ | 1,400,000 | ||||
Preclinical eValuation services |
432,000 | | ||||||
Total operating revenue |
3,710,000 | 1,400,000 | ||||||
COSTS AND OPERATING EXPENSES |
||||||||
Cost of personalized oncology services |
1,623,000 | 490,000 | ||||||
Cost of preclinical eValuation services |
357,000 | | ||||||
Research and development |
1,721,000 | 200,000 | ||||||
Impairment of intangible asset |
284,000 | | ||||||
General and administrative |
2,055,000 | 1,150,000 | ||||||
Total costs and operating expenses |
6,040,000 | 1,840,000 | ||||||
LOSS BEFORE OTHER INCOME |
(2,330,000 | ) | (440,000 | ) | ||||
Interest income |
88,000 | 29,000 | ||||||
LOSS BEFORE PROVISION FOR INCOME TAXES |
(2,242,000 | ) | (411,000 | ) | ||||
Provision for income taxes |
| | ||||||
NET LOSS |
$ | (2,242,000 | ) | $ | (411,000 | ) | ||
NET LOSS PER SHAREBASIC AND DILUTED |
$ | (0.07 | ) | $ | (0.01 | ) | ||
WEIGHTED AVERAGE SHARES OUTSTANDING BASIC AND
DILUTED |
33,266,000 | 31,494,000 | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-5
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS EQUITY
Common Stock | Additional | Accumulated | Treasury | |||||||||||||||||||||
Shares | Amount | Paid-in Capital | Deficit | Stock | Total | |||||||||||||||||||
Balance at April 30, 2007 |
27,625,000 | $ | 28,000 | $ | 6,815,000 | $ | (7,104,000 | ) | $ | | $ | (261,000 | ) | |||||||||||
Stock-based compensation expense |
| | 617,000 | | | 617,000 | ||||||||||||||||||
Acquisition of Biomerk, Inc. |
4,000,000 | 4,000 | 1,156,000 | | | 1,160,000 | ||||||||||||||||||
Issued common stock for cash |
1,429,000 | 1,000 | 2,499,000 | | | 2,500,000 | ||||||||||||||||||
Warrants exercised for cash |
169,000 | | 28,000 | | | 28,000 | ||||||||||||||||||
Options exercised for cash |
25,000 | | 4,000 | | | 4,000 | ||||||||||||||||||
Net loss |
| | | (411,000 | ) | | (411,000 | ) | ||||||||||||||||
Balance at April 30, 2008 |
33,248,000 | $ | 33,000 | $ | 11,119,000 | $ | (7,515,000 | ) | $ | | $ | 3,637,000 | ||||||||||||
Warrants exercised for cash |
216,000 | 1,000 | 49,000 | | | 50,000 | ||||||||||||||||||
Options exercised for cash |
25,000 | | 7,000 | | | 7,000 | ||||||||||||||||||
Stock returned by officer |
(500,000 | ) | | 1,000 | | (1,000 | ) | | ||||||||||||||||
Stock-based compensation expense |
| | 464,000 | | | 464,000 | ||||||||||||||||||
Net loss |
| | | (2,242,000 | ) | | (2,242,000 | ) | ||||||||||||||||
Balance at April 30, 2009 |
32,989,000 | $ | 34,000 | $ | 11,640,000 | $ | (9,757,000 | ) | $ | (1,000 | ) | $ | 1,916,000 | |||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-6
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year Ended April 30, | ||||||||
2009 | 2008 | |||||||
OPERATING ACTIVITIES |
||||||||
Net loss |
$ | (2,242,000 | ) | $ | (411,000 | ) | ||
Adjustments to reconcile net loss to net cash
(used in) provided by operating activities: |
||||||||
Impairment of intangible assets |
284,000 | | ||||||
Stock-based compensation |
464,000 | 617,000 | ||||||
Depreciation |
4,000 | | ||||||
Changes in operating assets and liabilities: |
||||||||
Prepaid expenses, deposits, and other receivables |
(668,000 | ) | (53,000 | ) | ||||
Accounts payable |
881,000 | 72,000 | ||||||
Accrued liabilities |
32,000 | 35,000 | ||||||
Deferred revenue |
718,000 | 505,000 | ||||||
Accrued salary due to officer and other accrued expenses |
(361,000 | ) | 27,000 | |||||
Net cash (used in) provided by operating activities |
(888,000 | ) | 792,000 | |||||
INVESTING ACTIVITIES |
||||||||
Purchase of certificate of deposit |
(1,017,000 | ) | | |||||
Purchase of property and equipment |
(69,000 | ) | | |||||
Purchase of intangibles |
(57,000 | ) | (47,000 | ) | ||||
Other |
(7,000 | ) | | |||||
Cash received in Biomerk acquisition |
| 471,000 | ||||||
Net cash (used in) provided by investing activities |
(1,150,000 | ) | 424,000 | |||||
FINANCING ACTIVITIES |
||||||||
Payment of officers loan payable |
| (44,000 | ) | |||||
Proceeds from sale of common stock |
| 2,500,000 | ||||||
Proceeds from exercise of options and warrants |
57,000 | 33,000 | ||||||
Net cash provided by financing activities |
57,000 | 2,489,000 | ||||||
NET (DECREASE) INCREASE IN CASH
AND CASH EQUIVALENTS |
(1,981,000 | ) | 3,705,000 | |||||
CASH AND CASH EQUIVALENTS
BEGINNING OF YEAR |
3,709,000 | 4,000 | ||||||
CASH AND CASH EQUIVALENTS END OF YEAR |
$ | 1,728,000 | $ | 3,709,000 | ||||
SUPPLEMENTAL CASH FLOW INFORMATION: |
||||||||
Cash paid during the year for: |
||||||||
Interest |
$ | | $ | 1,000 | ||||
Income tax |
$ | 7,000 | $ | | ||||
SUPPLEMENTAL DISCLOSURE OF NON-CASH TRANSACTIONS: |
||||||||
In May 2007, the Company issued 4,000,000 shares of our common stock for 100% of Biomerk, Inc. |
The accompanying notes are an integral part of these consolidated financial statements.
F-7
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
APRIL 30, 2009 AND 2008
Note 1. Organization and Basis of Presentation
Background
Champions Biotechnology, Inc., (the Company, we) is a biotechnology company that is
engaged in the development of advanced preclinical platforms and predictive tumor specific data to
enhance and accelerate the value of oncology drugs. In March
2009, the Company formed Champions Biotechnology UK Limited, a wholly owned subsidiary, in order to
establish operations in the United Kingdom and Israel.
Basis of Presentation
The accompanying consolidated financial statements have been prepared assuming the Company will continue as
a going concern, which contemplates the realization of assets and the satisfaction of liabilities
in the normal course of business. The Company has experienced recurring losses from operations
while developing its service offerings and expanding its sales channels. These operating losses are
expected to continue into the near future as the Company continues to expand. The Company will
require additional capital beyond the cash currently on hand to fund these expected near term
operating losses. To meet these capital needs, the Companys management is seeking to raise funds
from various sources, including both the private placements and public markets. There is no
assurance that the Company will succeed in these fund-raising
efforts, which could significantly restrict the Companys
ability to operate. The conditions and events described raise
substantial doubt about the Companys ability to continue as a
going concern. The consolidated financial statements do not include
any adjustments to reflect the possible future effects on the
recoverability and classification of assets or the amounts and
classification of liabilities that may result from the outcome of
this uncertainty.
Note 2. Summary of Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned
subsidiaries: Biomerk, Inc. and Champions Biotechnology UK, Limited. All material intercompany
transactions have been eliminated in consolidation.
Segment Reporting
The Company operates as a single operation, using core infrastructure that serves the oncology
needs of both personalized oncology and preclinical customers. The Companys chief operating
decision maker assesses the Companys performance as a whole and no expense or operating income is
generated or evaluated on any component level.
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosures of
contingent assets and liabilities at the date of the consolidated financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual results could differ
from those estimates.
Reclassifications
Certain prior year amounts have been reclassified to conform with the current year
presentation.
F-8
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
APRIL 30, 2009 AND 2008
Note 2. Summary of Significant Accounting Policies (Continued)
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with an original maturity of
three months or less, to be cash equivalents. At various times throughout the years, the Company
had amounts on deposit at financial institutions in excess of federally insured limits. Our highly
liquid investments are maintained at well-capitalized financial institutions to mitigate the risk
of loss.
Short-Term Investments
The Company classifies its short-term investments in certificates of deposits as
available-for-sale
securities in accordance with the provisions of Statement of
Financial Accounting Standards (SFAS) No. 115, Accounting for Certain Investments
in Debt and Equity Securities (SFAS 115). Available-for-sale investments are carried at fair
value as determined by quoted prices, with unrealized gains and losses reported as other
comprehensive income within stockholders equity. Unrealized losses considered to be
other-than-temporary are recognized currently in earnings. There were no other-than-temporary
losses recorded for the years ended April 30, 2009 and 2008. Interest income and realized gains and
losses, using the specific identification method, are included in other income. The short-term
investments all mature within one year.
Fair Value of Financial Instruments
The carrying value of cash and cash equivalents, short term
investments, accounts receivable, prepaid expenses,
deposits, and other receivables, accounts payable, accrued liabilities, and deferred revenue
approximate their fair value based on the liquidity or the short-term maturities of these
instruments.
SFAS No. 157, Fair Value Measurements (SFAS 157), establishes a fair value hierarchy that
prioritizes the inputs to valuation techniques used to measure fair value into three broad levels.
The fair value hierarchy gives the highest priority to quoted prices in active markets identical
assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3).
At April 30, 2009, the fair value of our short-term investments, which consist solely of a
certificate of deposit, was determined using Level 1 of the hierarchy of valuation inputs, with the
use of observable market prices in the active market. The unit of account used for valuation is
the individual underlying security. Because this security held by the Company is an investment,
assessment of non-performance risk in not applicable as such considerations are only applicable in
evaluating the fair value measurements for liabilities.
Property and Equipment
Property and equipment is recorded at cost and consists of laboratory equipment,
furniture and fixtures, and computer hardware and software. Depreciation is calculated on a
straight-line basis over the estimated useful lives of the various assets ranging from three to
seven years. Property and equipment consisted of the following:
April 30, | ||||||||
2009 | 2008 | |||||||
Furniture and fixtures |
$ | 26,000 | $ | | ||||
Computer equipment and software |
55,000 | | ||||||
Laboratory equipment |
4,000 | | ||||||
Total property and equipment |
85,000 | | ||||||
Less accumulated depreciation |
(4,000 | ) | | |||||
Property and equipment, net |
$ | 81,000 | $ | | ||||
Depreciation expense was approximately $4,000 and $0 for the fiscal years ended April 30, 2009
and 2008, respectively.
F-9
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
Note 2. Summary of Significant Accounting Policies (Continued)
Goodwill
Goodwill represents the excess of the cost over the fair market value of the net assets
acquired including identifiable assets. Goodwill is tested annually, or more frequently if
circumstances indicate potential impairment, by comparing its fair value to its carrying amount as
defined by Statement of Financial Accounting Standards (SFAS) No. 142, Goodwill and Other
Intangible Assets (SFAS 142). The determination of whether or not goodwill is impaired involves
significant judgment. Although the Company believes its goodwill is not impaired, changes in
strategy or market conditions could significantly impact the judgments and may require future
adjustments to the carrying value of goodwill.
Intangible Assets
Intangible assets represent costs incurred for acquired patents and patent applications
expected to be licensed in the near future. Intangible assets are
tested for impairment if an impairment indicator arises. An
impairment loss is recognized to the extent that the carrying amount
exceeds the expected future undiscounted cash flows. See Note 4
for further discussion of an identified impairment in fiscal 2009.
Deferred Revenue
Deferred revenue represents payments received in advance for services to be performed. When
services are rendered, deferred revenue is then recognized as earned.
Revenue Recognition
The Company derives revenue from Personalized Oncology and
Preclinical eValuation services. Personal Oncology Services assist
physicians by providing information that may enhance personalized
treatment options for their cancer patients through access to
expert medical information panels and tumor specific data. The
Companys Preclinical eValuation services offer a preclinical
tumorgraft platform to pharmaceutical and biotechnology companies
using Biomerk Tumorgraft studies, which have been shown to be
predictive of how drugs may perform in clinical settings. The
Company recognizes revenue when the four basic criteria of the
SECs Staff Accounting Bulletin No. 104, Revenue Recognition
(SAB 104) are met: 1) a contract has been entered into with our
customers; 2) delivery has occurred or services rendered to our
customers; 3) the fee is fixed and determinable as noted in the
contract; and 4) collectability is reasonably assured, as fees for
services are received in full upon execution of the contract. The
Company utilizes a proportional performance revenue recognition
model for its preclinical eValuation services under which we
recognize revenue as performance occurs, based on the relative
outputs of the performance that have occurred up to that point in
time under the respective agreement, typically the delivery of
reports to our customers documenting the results of our testing
protocols.
When a Personalized Oncology or Preclinical eValuation arrangement involves multiple
elements, the items included in the arrangement
(deliverables) are evaluated pursuant to Emerging Issues Task
Force (EITF) Issue
No. 00-21, Revenue Arrangements with Multiple Deliverables, to determine whether they represent
separate units of accounting. We perform this evaluation at the inception of an arrangement and as
we deliver each item in the arrangement. Generally, we account for a deliverable (or a group of
deliverables) separately if: (1) the delivered item(s) has standalone value to the customer, (2)
there is objective and reliable evidence of the fair value of the undelivered items included in the
arrangement, and (3) if we have given the customer a general right of return relative to the
delivered item(s), delivery or performance of the undelivered item(s) or service(s) is probable and
substantially in our control. All revenue from contracts determined not to have separate units of
accounting is recognized based on consideration of the most substantive delivery factor of all the
elements in the arrangement.
Cost of Personalized Oncology Services
Cost of personalized oncology services consists of costs related to personalized oncology
revenue from oncology panels, implantations, vaccine development and studies. Along with the
internal cost of salaries for
personnel directly engaged in these services, this includes physicians honorariums and panel
participation costs including travel, lodging, and meals, laboratory and testing fees and
administrative costs. Costs associated with implantations are primarily consulting fees
and laboratory expenses. Vaccines and studies costs are primarily from contract research
organizations for conducting the related studies.
F-10
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
Note 2. Summary of Significant Accounting Policies (Continued)
Cost of Preclinical eValuation Services
Cost
of Preclinical eValuation services consists of expenses related to Preclinical eValuation
revenues. Along with the internal cost of salaries directly related to Preclinical eValuation
services these costs include charges from contract research organizations for conducting
the related clinical evaluation.
Research and Development
Research and development expense represent both costs incurred internally for research and
development activities as well as costs incurred externally to fund
research and development activities. All
research and development costs are expensed as incurred. We account for non-refundable advance
payments for future research and development activities in accordance with EITF 07-03, Accounting
for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and
Development Activities which requires that nonrefundable advance payments be capitalized and
recorded as expense when the respective product or services are determined.
Basic and Diluted Loss Per Common Share
Basic
and diluted loss per common share (EPS) are calculated
in accordance with SFAS No. 128, Earnings Per Share (SFAS 128). Basic loss per common share is computed by dividing our net
loss by the weighted average number of common shares outstanding during the period excluding the
dilutive effects of options and warrants.
For 2009 and 2008, diluted loss per common share is computed on the same basis as basic loss
per common share, as the inclusion of potential common shares
would be anti-dilutive. The table below reflects the potential weighted average incremental shares of common stock
equivalents that have been excluded from the computation of diluted loss per common share since their
effect would be anti-dilutive.
Year Ended April 30, | ||||||||
2009 | 2008 | |||||||
Stock options |
371,605 | 359,146 | ||||||
Warrants |
473,237 | 486,070 | ||||||
Total common stock equivalents |
844,842 | 845,216 | ||||||
Stock-Based Compensation
SFAS No. 123(R) requires the Company to
calculate the fair value of stock-based awards on the date of grant. The Company used the
Black-Scholes option pricing model to estimate fair value. The option pricing model requires the
Company to estimate certain key assumptions such as expected life, volatility, risk free interest
rates, and dividend yield to determine the fair value of stock-based awards, based on historical
information and management judgment. The Company amortizes the stock-based compensation expense
over the period that the awards are expected to vest, net of estimated forfeiture rates. If the
actual forfeitures differ from management estimates, adjustments to compensation expense are
recorded. The Company reports cash flows resulting from tax deductions in excess of the
compensation cost recognized from those options (excess tax benefits) as financing cash flows.
In March 2005, the SEC issued Staff Accounting Bulletin
No. 107 Share-Based Payment (SAB
107), relating to SFAS No. 123(R), and in December 2007, the SEC issued Staff Accounting Bulletin
No 110 Share-Based Payment (SAB 110). SAB 110 allows companies to continue to use the
simplified method, as defined in SAB 107, to estimate the expected term of stock options under
certain circumstances. The simplified method for estimating the expected life uses the mid-point
between the vesting term and the contractual term of the stock option. The Company has analyzed
the circumstances in which the simplified method is allowed and is utilizing the simplified method
for all stock options and warrants granted.
F-11
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
Note 2. Summary of Significant Accounting Policies (Continued)
The Company measures compensation expense for its non-employee stock-based compensation under
EITF Issue No. 96-18,
Accounting for Equity Instruments that are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services (EITF 96-18). The fair value of the option issued is
used to measure the transaction, as this is more reliable than the fair value of the services
received. The fair value is measured at the value of the Companys common stock on the date that
the commitment for performance by the non-employee consultant has been reached or the
consultants performance is complete.
Income Taxes
The Company accounts for income taxes as prescribed by SFAS No. 109, Accounting for Income
Taxes (SFAS 109). SFAS 109 prescribes the use of the asset and liability method to compute the
differences between the tax basis of assets and liabilities and the related financial amounts using
currently enacted tax laws.
The Company has deferred tax assets, which are subject to periodic recoverability assessments.
Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount
that more likely than not will be realized. Realization of the deferred tax assets is principally
dependent upon achievement of projected future taxable income offset by deferred tax liabilities.
Effective May 1, 2007, the Company adopted FASB Interpretation No. 48, Accounting for
Uncertainty Income Taxes (FIN 48). FIN 48 prescribes a more-likely-than-not threshold for
financial statement recognition and measurement of a tax position taken or expected to be taken in
a tax return. For the years ended April 30, 2009 and 2008, the Company did not identify any uncertain tax
positions and has not accrued for any liabilities.
Recent Accounting Pronouncements
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets
and Liabilities, including an amendment of FASB Statement No. 115 (SFAS 159). SFAS No. 159
permits entities to choose, at specified election dates, to measure many financial instruments and
certain other items at fair value that are not currently required to be measured at fair value.
Unrealized gains and losses are recognized on items for which the fair value option has been
elected in earnings in each subsequent reporting date. SFAS No. 159 was effective for the Company
on May 1, 2008. The Company chose not to voluntary measure any financial assets and liabilities at
fair value and the adoption of SFAS 159 did not have an impact of the consolidated results of
operations and financial condition.
In December 2007, the FASB issued SFAS No. 141 (revised 2007), Business Combinations (SFAS
141(R)). SFAS 141(R) establishes principles and requirements for how an acquirer recognizes and
measures in its financial statements the identifiable assets acquired, the liabilities assumed, any
non-controlling interest in the acquire and the goodwill acquired in connection with business
combinations. SFAS 141(R) also establishes disclosure requirements to enable the evaluation of the
nature and financial effects of the business combination. SFAS 141(R) is effective for the Company
beginning on or after May 1, 2009. The adoption of SFAS 141(R)
will change how future acquisitions are recorded and reported.
In December 2007, the FASB ratified the consensuses reached in Emerging Issue Task Force,
or EITF, Issue No. 07-1, Collaborative Arrangements (EITF 07-1). EITF 07-1 defines
collaborative arrangements and establishes reporting requirements for transactions between
participants in a collaborative arrangement and between participants in the arrangements and third
parties. Under EITF 07-1, payments between participants pursuant to a collaborative arrangement
that are within the scope of other authoritative accounting literature on income statement
classification should be accounted for using the relevant provisions of that literature. If the
payments are not within the scope of other authoritative accounting literature, the income
statement classification for the payments should be based on an analogy to authorize accounting
literature or if there is no appropriate analogy, a reasonable, rational, and consistently applied
accounting policy election. EITF 07-1 also provides disclosure requirements and is effective for
the Company on May 1, 2009. The effect of applying EITF 07-1 will be reported as a change in
accounting principle through retrospective applications to all prior periods presented for all
collaborative arrangements existing as of the effective date, unless it is impracticable. The
Company does not expect that the impact that the adoption of EITF 07-1 will have a material impact
on its consolidated financial statements.
In
May 2009, the FASB issued SFAS No. 165, Subsequent Events
(SFAS 165). SFAS 165 defines subsequent events as events
or transactions that occur after the balance sheet date, but before
the financial statements are issued. It defines two types of
subsequent events: recognized subsequent events, which provide
additional evidence about conditions that existed at the balance
sheet date, and non-recognized subsequent events, which provide
evidence about conditions that did not exist at the balance sheet
date, but arose before the financial statements were issued.
Recognized subsequent events are required to be recognized in the
financial statements, and non-recognized subsequent events are
required to be disclosed. The statement requires entities to disclose
the date through which subsequent events have been evaluated, and the
basis for that date. In accordance with this statement, an entity
will adopt the requirements of SFAS 165 in the first quarter of
fiscal 2010. The Company does not expect the requirements to have a
material impact on the Companys consolidated financial
statements and disclosures.
F-12
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
Note 3. Commitments and Contingencies
Operating leases
The Company leases office and laboratory space under a non-cancelable operating lease in
Baltimore, MD, which expires April 2010, and offices, under a non-cancelable operating lease in
Tempe, AZ which expires May, 2011.
Under the terms of the Baltimore lease the Company can extend the term of the one year lease
for five additional one year periods after the Company provides written notice to do so. The
monthly lease payment for the initial lease is $5,500.
Under the terms of the Tempe lease the Company has no extension provision at the end of the
initial two year lease. The monthly lease payment for the initial two year lease is $4,250 in year
one and $4,750 in year two.
Future minimum lease payments under operating leases due each year are as follows at April 30,
2009:
2010 |
$ | 115,000 | ||
2011 |
57,000 | |||
2012 and thereafter |
2,000 | |||
Total minimum payments |
$ | 174,000 | ||
Rent expense was approximately $89,000 and $9,000 for the years ended April 30, 2009 and 2008,
respectively.
Legal
Matters
The Company is party to certain legal matters arising in the ordinary
course of its business. The Company has evaluated its potential
exposure to these legal matters, and has recorded amounts in the
financial statements accordingly. The Company is not aware of any
other matters that would have a material impact on the Companys
financial position or results of operations.
Note 4. Impairment of Intangible Assets
The Companys Polymerization Inhibitors: Benzoylphenylurea (BPU) Sulfur Analogs patent
applications were acquired in 2007 and since then the Company has spent approximately $100,000 on
ongoing patent legal fees in anticipation of pursuing licensing or development partnering
opportunities for these patents. During the fourth quarter of fiscal 2009, the Company identified
indicators of impairment in its BPU patents based on changes in the
current market conditions and expectations of near term
commercialization. SFAS
No. 144 Accounting for the Impairment or Disposal of
Long-Lived Assets requires an impairment loss be recognized for an amortizable intangible asset whenever the
net cash in-flow to be generated from an asset is less that its
carrying cost. As the Company was unable to determine the timing or amount of net cash
in-flow to be generated from a BPU licensing and/or partnering
agreement, we were unable to support the carrying value of the
intangible asset. Accordingly, the Company
recognized an impairment loss for the amount of unamortized BPU patent costs of $284,000 in 2009.
Note 5. Stock-Based Compensation Plan
The Company may grant (i) Incentive Stock Options, (ii) Non-statutory Stock Options, (iii)
Restricted Stock Awards, and (iv) Stock Appreciation Rights
(collectively, stock-based compensation) to its employees, Directors and non-employee consultants under a 2008 Equity Incentive Plan that has not yet
been approved by the companys shareholders. Such awards may be granted by the Companys Board of
Directors. Options granted under the plan expire no later than ten years from the date of grant
and the awards vest as determined by the Board of Directors.
F-13
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
Note
5. Stock-Based Compensation Plan (Continued)
Stock-based compensation in the amount of $464,000 and $617,000 was recognized for the years
ended April 30, 2009 and 2008, respectively. Stock-based compensation costs were recorded as
follows:
Years Ended April 30, | ||||||||
2009 | 2008 | |||||||
Personalized oncology service |
$ | 4,000 | $ | | ||||
Preclinical eValuation service |
4,000 | | ||||||
Research and development |
127,000 | | ||||||
General and administrative |
329,000 | 617,000 | ||||||
Total share-based compensation expense |
$ | 464,000 | $ | 617,000 | ||||
Black-Scholes assumptions were as follows:
Year Ended April 30, | ||||||||
2009 | 2008 | |||||||
Expected term in years |
1.5 - 6.0 | 2.0 - 3.5 | ||||||
Risk free interest rates |
1.9% - 3.4% | 2.5% - 4.6% | ||||||
Volatility |
69% - 94% | 83% - 89% | ||||||
Dividend yield |
0% | 0% |
Stock Option Grants
The Companys stock options activity, and outstanding, exercisable, exercised and forfeited
categorized as employees/directors and consultants are as follows:.
Weighted | ||||||||||||||||||||
Average | ||||||||||||||||||||
Directors | Remaining | Aggregate | ||||||||||||||||||
and | Contractual | Intrinsic | ||||||||||||||||||
Consultants | Employees | Total | Life (Years) | Value | ||||||||||||||||
Outstanding as of
April 30, 2007 |
340,000 | | 340,000 | |||||||||||||||||
Granted |
1,500,000 | 140,000 | 1,640,000 | |||||||||||||||||
Exercised |
(25,000 | ) | | (25,000 | ) | |||||||||||||||
Outstanding as of
April 30, 2008 |
1,815,000 | 140,000 | 1,955,000 | |||||||||||||||||
Granted |
20,000 | 398,333 | 418,333 | |||||||||||||||||
Exercised |
(25,000 | ) | | (25,000 | ) | |||||||||||||||
Change in
employee status |
(500,000 | ) | 500,000 | | ||||||||||||||||
Outstanding as of
April 30, 2009 |
1,310,000 | 1,038,333 | 2,348,333 | 4.83 | $ | 594,000 | ||||||||||||||
Exercisable as of
April 30, 2009 |
806,667 | 46,667 | 853,334 | 3.51 | $ | 396,000 | ||||||||||||||
The Companys Board has not approved a limit to the number of shares available for issuance
under the Companys 2008 Equity Incentive plan, and as such the Board approves each grant individually.
F-14
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
Note
5. Stock-Based Compensation Plan (Continued)
Additional information regarding options outstanding as of April 30, 2009 is as follows:
Options Outstanding | Options Exercisable | |||||||||||||||||||
Range of | Weighted Average | Weighted | Weighted | |||||||||||||||||
Exercise | Number | Contractual Life | Average | Number | Average | |||||||||||||||
Prices | Outstanding | (Yrs) | Exercise Price | Exercisable | Exercise Price | |||||||||||||||
$0.17 $0.30 |
815,000 | 2.95 | $ | 0.25 | 481,667 | $ | 0.21 | |||||||||||||
$0.75 $0.87 |
515,000 | 3.61 | $ | 0.75 | 166,667 | $ | 0.75 | |||||||||||||
$1.00 $1.18 |
1,018,333 | 6.95 | $ | 1.14 | 205,000 | $ | 1.12 | |||||||||||||
$0.17 $1.18 |
2,348,333 | 4.83 | $ | 0.75 | 853,334 | $ | 0.54 | |||||||||||||
On May 15, 2007, the Company granted a consultant 500,000 stock options at $0.30 per share, as
incentive for joining the Board of Directors and to serve as the Companys scientific advisor.
Under this grant, the Company recorded approximately $6,400 of stock compensation expense in the
first quarter 2008, until June 11, 2007, when the consultant accepted his appointment to the
Companys Board of Directors and agreed to serve as the Companys scientific advisor. The date of
appointment was considered a performance commitment and the Company re-measured the fair value of
the award and began recording the remaining compensation expense under the award ratably over the
remaining vesting period. Following the Board appointment, the Company recorded $60,600 in stock
compensation expense until March 31, 2008. On this date, the individual resigned from the Board and
returned to a consulting role. This change in employment status was recognized
prospectively under EITF 96-18 such that the fair value of the award are re-measured at each
subsequent reporting period until the awards are fully vested. The modification resulted in a
$14,700 charge to expense for the remaining period in 2008 and $126,900 charge to expense for the
year ended April 30, 2009.
On October 10, 2007, the Company granted a consultant options
vesting over three years to acquire
500,000 shares of common stock at an exercise price of $0.75 per
share. Under this grant, the
Company recorded approximately $72,000 of stock compensation expense while re-measuring the options
at each reporting date, until the consultant was hired on as the Companys Chief Executive Officer
on March 31, 2008. On this date, a performance commitment was set and the Company determined the
final valuation of the options, recording the remaining under the award expense ratably over the
remaining vesting period. Following the employment of this consultant, the Company recorded
$10,300 and $124,000 in stock compensation expense for the years ended April 30, 2008 and 2009,
respectively.
Note 6. Stockholders Equity
Preferred Stock
The Company has 56,075 shares of Series A 12% preferred stock authorized and no shares issued
and outstanding at April 30, 2009.
Common Stock
In February 2007, the Company acquired the patent rights to two Benzoylphenylurea (BPU) sulfur
analog compounds in exchange for 300,000 shares of the Companys unregistered common stock with an
additional 250,000 shares to be issued upon final approval of the acquired patent.
On May 18, 2007, the Company acquired Biomerk, Inc. and issued 4,000,000 unregistered shares
of its common stock. On April 30, 2008, the Company issued 1,428,572 unregistered shares of the
Companys common stock at $1.75 per share for total cash proceeds of $2,500,000 pursuant to the
terms of a private investment financing.
F-15
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
Note
6. Stockholders Equity (Continued)
Warrants
In October 2006, in conjunction with the cancellation and exchange of 32,450 outstanding
shares of our Series A 12% Convertible preferred stock for 1,000,000 shares of our common stock,
the Company issued warrants to purchase up to 1,000,000 shares of common stock at an exercise price
of $0.15 and $0.25 per share. The warrants have a five year life, expiring in October 2011.
In August 2008, in conjunction with a consulting agreement, the Company issued warrants for
the purchase of up to 150,000 shares of our common stock at an exercise price of $1.00 per share
vesting on June 30, 2009 and expiring in July 2014. The number of warrants issued under the
consulting agreement is subject to a clawback feature if the consulting agreement is terminated
before its expiration date of June 30, 2009. No warrants were
ever subject to this clawback feature.
During the year ended April 30, 2009 and 2008, warrants for 216,121 and 169,488, respectively,
were exercised for total cash proceeds of approximately $50,000 and $28,000, respectively.
Warrants outstanding for the purchase of common stock are as follows:
April 30, | ||||||||||||
Exercise price | Expiration date | 2009 | 2008 | |||||||||
$0.15 |
January 15, 2012 | 315,104 | 361,328 | |||||||||
$0.25 |
January 15, 2012 | 299,287 | 469,184 | |||||||||
$1.00 |
October 20, 2013 | 150,000 | | |||||||||
764,391 | 830,512 | |||||||||||
Weighted average exercise price | $ | 0.36 | $ | 0.20 | ||||||||
As of April 30, 2009 and 2008, there were exercisable outstanding warrants of 614,391 and
830,512, respectively.
Note 7. Provision for Income Taxes
For the years ended April 30, 2009 and 2008, the Company recorded a provision for income taxes
of $0 in each year. The components of the provision are as follows:
Federal | State | Total | ||||||||||
2009 |
||||||||||||
Current |
$ | | $ | | $ | | ||||||
Deferred |
(313,000 | ) | (68,000 | ) | (381,000 | ) | ||||||
Change in valuation allowance |
313,000 | 68,000 | 381,000 | |||||||||
Total Current |
| | | |||||||||
2008 |
||||||||||||
Current |
| | | |||||||||
Deferred |
(64,000 | ) | (31,000 | ) | (95,000 | ) | ||||||
Change in valuation allowance |
64,000 | 31,000 | 95,000 | |||||||||
Total Current |
$ | | $ | | $ | | ||||||
F-16
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
Note 7. Provision for Income Taxes (Continued)
A reconciliation between the Companys effective tax rate and the U.S. statutory tax rate for
the years ended April 30, 2009 and 2008 is as follows:
Year Ended April 30, | ||||||||
2009 | 2008 | |||||||
Federal income tax at statutory rate |
35.0 | % | 35.0 | % | ||||
State income tax, net of federal benefit |
4.5 | % | 4.5 | % | ||||
Permanent difference |
-0.3 | % | -0.2 | % | ||||
Other True-ups |
0.0 | % | -18.2 | % | ||||
Change in valuation allowance |
-39.2 | % | -21.1 | % | ||||
Income tax expense |
0.0 | % | 0.0 | % | ||||
Deferred income taxes reflect the net tax effects of temporary differences between the
carrying amounts of assets and liabilities for financial reporting purposes and the amounts used
for income tax purposes. Significant components of the Companys deferred tax assets and
liabilities as of April 30, 2009 and 20087 consist of the following:
April 30, | ||||||||
2009 | 2008 | |||||||
Accrued liabilities |
$ | 7,000 | $ | | ||||
Depreciation and amortization |
(10,000 | ) | 71,000 | |||||
State taxes |
(72,000 | ) | (95,000 | ) | ||||
Stock-based compensation expense |
450,000 | 255,000 | ||||||
Charitable
contribution carry-forwards |
41,000 | 41,000 | ||||||
Net
operating loss carry-forwards |
739,000 | 1,264,000 | ||||||
Total deferred tax assets |
1,155,000 | 1,536,000 | ||||||
Less: valuation allowance |
(1,155,000 | ) | (1,536,000 | ) | ||||
Net deferred tax asset |
$ | | $ | | ||||
At April 30, 2009, the Companys estimated net operating
loss carry-forwards were
approximately $1,759,000. The Companys federal net operating losses expire between
2023 and 2029, and its state net operating losses expire between 2010 and 2029.
The Company is in the process of evaluating its acquired net
operating loss carryforwards and the impact
of applicable Internal Revenue Code Section 382 limitations on those net operating losses. The reason the
Companys net operating loss carryforwards decreased from fiscal 2008 to 2009 is due in part to a write-off of
net operating loss carryforwards from pre acquisition periods that the Company does not believe it will ever be
able to utilize. As the Company previously established a full valuation allowance against its net
operating loss carryforwards, there was no impact on net loss.
F-17
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2009 AND 2008
Note 7. Provision for Income Taxes (Continued)
The Companys practice is to recognize interest and/or penalties related to income tax matters
in income tax expense. The Company had no accrual for interest or penalties on the Companys
balance sheets at April 30, 2009 or April 30, 2008, and has not recognized interest and/or
penalties in the statement of operations for either period.
The Company is subject to taxation in the United States and various state jurisdictions. The
Companys tax years for period ending April 30, 1994 and forward are subject to examination by the
United States and certain states due to the carryforward of unutilized net operating losses.
Note 8. Related Party Transactions
Related party transactions include transactions between the Company and certain of its
stockholders, management and affiliates. The following transactions were in the normal course of
operations and were measured at the exchange amount, which is the amount of consideration
established and agreed to by the parties.
During the years ended April 30, 2009 and 2008, we paid our Chairman of the Board of Directors
$105,000 and $0, respectively, for consulting services rendered to the Company.
During the year ended April 30, 2009, we recognized approximately $216,000 in revenues from
companies whose board members were also members of our Board of Directors.
We incurred $180,000 and $55,000 in expense for the years ended April 30, 2009 and 2008,
respectively from a substantial stockholder of the Company for consulting fees. No amounts were
payable to this stockholder as of April 30, 2009 and 2008.
In May 2009, the Board of Directors approved a stock repurchase agreement with a Board member
to purchase $281,250 of the Companys common stock held over the next
five quarters providing that the Board member continues his services
under a separate consulting agreement
executed in conjunction with the stock repurchase agreement. Under
the stock repurchase agreement, the Company will
repurchase shares of common stock at the lesser of (a) $0.50 per
share or (b) 50% of the average
volume-weighted closing price of the stock as quoted on the OTC Bulletin Board for the 30 day
trading period ending on the day before the date of each purchase as long as the consulting
agreement remains in effect. The Company may also purchase up to 2,250,000 shares of the common stock
from this Board member at the discretion of the Company subject to the above commitment and pricing formula.
In May 2009, we paid this Board member approximately $156,000 for the purchase of 312,500
shares of our common stock under the above agreement.
Note 9. Subsequent Events
In July 2009, the Company entered into a Joint Development and Licensing Agreement with a
third party for the development of a soluble from of SG410, the Companys Benzoylyphenylurea (BPU)
sulfur analog compound. Under the Joint Agreement, the third party will be entitled to milestone
payments upon the successes of certain regulatory approvals and
royalty payments on net
sales of the licensed BPU product.
F-18
Table of Contents
EXHIBIT INDEX
Exhibits No. | ||||
2.1 | Biomerk Agreement and Plan of Merger (incorporated by reference to Exhibit 10.1 of Form 8-K filed on May 24, 2007) |
|||
3.1 | Articles of Incorporation* |
|||
3.2 | Bylaws, as amended* |
|||
10.1 | Employment
Agreement dated March 27, 2008 between the Company and Douglas
D. Burkett (incorporated by reference to Exhibit 10.1 of the
April 30, 2008 Form 10-KSB) |
|||
10.2 | Employment
Agreement dated March 31, 2008 between the Company and James Martell (incorporated by reference to Exhibit 10.2 of the
April 30, 2008 Form 10-KSB) |
|||
10.3 | Employment Agreement dated March 26, 2008 between the Company and Durwood C. Settles (incorporated by reference to Exhibit 10.3 of the
April 30, 2008 Form 10-KSB) |
|||
10.4 | Employment Agreement dated January 5, 2009 between the Company and Mark R. Schonau* |
|||
10.5 | Consulting Agreement dated May 18, 2009 between the Company and James Martell.* |
|||
10.6 | Stock Repurchase Agreement dated May 18, 2009 between the Company and James Martell.* |
|||
10.7 | Lease of Maryland facility (incorporated by reference to Exhibit 10.1 of January 31, 2009 Form 10-Q) |
|||
10.8 | Agreement re: Patent Application acquisition (incorporated by reference to exhibit 10 of Form 8-K filed on February 16, 2007) |
|||
14 | Code of Ethics (incorporated by reference to Exhibit 14 of the
April 30, 2008 Form 10-KSB) |
|||
21 | Subsidiaries of the Registrant* |
|||
31.1 | Rule 13a-14(a)/15d-14(a)
Certification of President and Principle Executive Officer* |
|||
31.2 | Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer* |
|||
32.1 | Section 1350 Certifications* |
* | Filed herewith |