CHAMPIONS ONCOLOGY, INC. - Annual Report: 2010 (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, 2010
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 | (I.R.S. Employer | |
or organization) | Identification No.) |
855 N. Wolfe Street, Suite 619, Baltimore, MD 21205
(Address of principal executive offices, including zip code)
(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
(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 (do not check if a smaller reporting company) | Smaller reporting company þ |
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 (OTC) 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, 2009,
was approximately $8,903,000.
As of
July 28, 2010, the Registrant had a total of 35,701,996 shares of common stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
None
TABLE OF CONTENTS
3 | ||||||||
3 | ||||||||
6 | ||||||||
12 | ||||||||
12 | ||||||||
13 | ||||||||
14 | ||||||||
18 | ||||||||
18 | ||||||||
18 | ||||||||
19 | ||||||||
19 | ||||||||
21 | ||||||||
24 | ||||||||
25 | ||||||||
26 | ||||||||
PART IV |
||||||||
26 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 |
2
Table of Contents
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.
Current Business
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 to Biomerk
shareholders. Since that time, the Companys business is 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
vivo) 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 an agreement with a United States based preclinical
contract research organization.
3
Table of Contents
We intend to leverage our preclinical
platform to evaluate oncology drug compounds and to
develop a portfolio of novel drug compounds that we intend to develop through preclinical trials.
As drugs progress through this early stage of development, the Company plans to sell, partner or
license such drugs to pharmaceutical and/or biotechnology companies. We believe this strategy will
enable the Company to leverage the competencies of these partners or licensees to maximize the
Companys return on investment in a time frame that is shorter than for 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, which requires a very large financial commitment and a long development
period, typically more than a decade, to commercialize. Thus far we have acquired four drug
compounds through purchase, exclusive worldwide licensing and/or option agreements. Of our four
drug compounds, we have begun preclinical testing of three and expect to start testing the fourth
compound in the first or second quarter of fiscal 2011. If results are promising for any of our
drug compounds it is our intention to continue preclinical development and then sell, partner, or
license the drug compound 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 who use this information to
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 drugs on their patients tumorgrafts enabling them to better select
treatment regimens that may be efficacious to the patient. For the year ended April 30, 2010, our
revenues from POS totaled $3,206,000, a decrease of 2% from the previous year.
During the fiscal year ended April 30, 2009, as we expanded our number of Biomerk Tumorgraft
models, we began to offer leading pharmaceutical and biotechnology companies the benefits of our
Biomerk Tumorgrafts for their preclinical evaluation programs. We provide Preclinical eValuation
services (PCE) that we believe are more predictive of clinical outcomes and that might provide
for a faster and less expensive path to drug approval. These services utilize Biomerk Tumorgrafts
to evaluate tumor sensitivity/resistance to various single, combination standard and novel
chemotherapy agents. The Preclinical eValuation services also include biomarker discovery and the
identification of novel drug combinations. The Company began deriving revenues from its PCE
services in fiscal 2009 and completed its first full year of business in fiscal 2010. During the
fiscal year 2010, the Company saw its PCE services business bring in new customers and follow on
business from previous customers. For the year ended April 30, 2010, our revenues from PCE
services totaled $1,687,000, an increase of 290% over the previous year.
Operations
For the fiscal year ended April 30, 2010, the Company generated operating revenue of
$4,893,000, comprised of $3,206,000 from Personalized Oncology services and $1,687,000 Preclinical
eValuation services, an overall increase of 32% over our revenues for the fiscal year ended April 30, 2009.
4
Table of Contents
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 in the United States and abroad. 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 Biomerk
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 United
States and international patent applications, both broad and specific, where necessary and
reasonable. In February 2007, the Company acquired the patent rights to two BPU sulfur analog
compounds that have shown promising potent activity against in vitro and in vivo models of prostate
and pancreatic cancer. The acquired rights include pending United States 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 Sulfur Analogs. In October 2009, the United States
Patent Office and Trademark office issued United States Patent 7,595,326 entitled Synthesis of
Novel Tubulin Polymerzation Inhibitors: Benzoylphenylurea (9BPU) Sulfur Analogs.
Research and Development
For the fiscal years ended April 30, 2010 and 2009, the Company spent approximately
$2,695,000 and $1,721,000, respectively, on research and development to develop our preclinical platform and
expand our Preclinical eValuation Platform. The increase from 2009 to 2010 was primarily related
to the development of the platform and costs associated with our licensing and development efforts
of our four drug compounds.
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 United States Food and
Drug Administration (FDA) 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 compounds to pharmaceutical and/or
biotechnology companies, as appropriate prior to pursuing the FDA approval necessary to
commercially market its drug products.
Employees
As of April 30, 2010, the Company had seven full-time employees.
Company
History
The Company was incorporated as a merger and acquisition
company under the laws of the State of Delaware on June 4, 1985,
under the 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.
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.
5
Table of Contents
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 incurred losses from operating activities, expect losses for the foreseeable
future, require significant capital and may never achieve profitability.
For
the fiscal years ended April 30, 2010 and 2009, the Company had
a net loss of $2,923,000
and $2,242,000, respectively. As of April 30, 2010, the Company has an accumulated deficit of
$12,680,000.
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; |
| the cost of identifying and
licensing drug development compounds; |
| the progress and cost of preclinical and possibly early phase clinical development
programs; |
| the cost of building out our Preclinical eValuation Tumorgraft platform; |
| the cost and rate of progress toward growing our POS businesses; |
| the cost of acquiring and operating our own laboratory and animal testing facilities; |
| the cost of securing and defending our intellectual property; |
| the timing and cost of obtaining necessary regulatory approvals; |
| the cost of expanding and building out the infrastructure of our United States and
overseas operations; |
| the cost incurred in hiring and maintaining qualified personnel; |
| the costs of any future litigation of which we may be subject; and |
| the cost of adopting the provisions of section 404 of the Sarbanes-Oxley Act. |
Currently, the Company derives revenue from two sources: POS and PCE services, while we pursue
drug development opportunities. All of these business activities
require significant research and development
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 research and development and general and administrative expenses. We may not achieve
or, if achieved, sustain our revenue or profit objectives. 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
compounds
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 fundraising distracts them from concentrating on our
business affairs.
The Company currently uses third party laboratory and animal
facilities.
Currently, the Company does not own its own laboratory and animal facility.
Although the Company has plans to acquire our own facilities, by not owning our
own vivarium animal testing facility, the cost of testing done by third parties
may be higher than if we performed the services on our own. Further, although
we have quality control provision in our contracts with such third parties,
we may not be assured that the work being performed on our behalf will meet the
quality standards and timelines we would have met if we were controlling the
work directly within our facility.
6
Table of Contents
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 initial four drug compounds, specifically, the BPU sulfur analog compounds, TAR-1,
Ironophore C and Bithionol, 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; |
||
| prove to be safe and efficacious in preclinical or clinical trials; |
||
| meet applicable regulatory standards or obtain required regulatory approvals; |
||
| demonstrate substantial protective or therapeutic benefits in the prevention or
treatment of any disease; |
||
| be capable of being formulated and/or produced in clinical or commercial
quantities at reasonable costs; |
||
| obtain coverage and favorable reimbursement rates from insurers and other
third-party payors; or |
||
| 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 compounds, we will have to build a
marketing and sales 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 seven full-time employees, the loss
of the services of one or more of which would 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 has seen 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 capabilities. Accordingly, our competitors may succeed in obtaining patent protection,
receiving FDA approval or commercialization of similar competing drug compounds before we do. We
compete with companies with greater marketing and manufacturing capabilities, areas in which we
have limited or no experience. We also compete in a market that has a less than 10% success rate
in bringing new products to market.
7
Table of Contents
Academic institutions, hospitals, governmental agencies and other public and private research
organizations are also conducting research, 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.
Not only will we face competition from well established companies, new companies will likely
enter our market from the United States and abroad 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 us,
that could compete with us in our market. |
| 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. |
| 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. |
| 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. |
| 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. |
8
Table of Contents
| 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. |
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; |
||
| divert the time and attention of our technical personnel and management; |
||
| cause product development delays; |
||
| require us to develop non-infringing technology; or |
||
| 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, 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.
9
Table of Contents
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; |
|
| the price of our products relative to that of our competitors; |
|
| the timing of our market entry; and |
|
| 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 several Contract Research Organizations (CRO) to perform a majority of
our tumor studies and develop and bank our Tumorgraft platform. If any of these facilities were to
be significantly damaged or destroyed, we could suffer a loss of some of our ongoing and future
drug studies as well as our Tumorgraft bank. While we believe that our CROs have risk management
procedures in place and are 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 where our
Tumorgraft bank will be housed in different locations to avoid a catastrophic event damaging this
asset.
10
Table of Contents
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 July 28, 2010, we had 36,844,311 shares of
common stock issued and 35,701,996 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,
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 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 over-the-counter (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.
The exercise of outstanding options and warrants may dilute current shareholders.
As
of July 28, 2010, there were outstanding warrants and options to purchase approximately
4,312,000 shares of our common stock. The exercise of a substantial number of these outstanding
warrants and options could adversely affect our share price and dilute current shareholders.
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 compounds 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; |
||
| 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. |
11
Table of Contents
Our common stock may be deemed a penny stock, which would make it more difficult for you to sell
your shares.
Our common stock is subject to the penny stock rules adopted under Section 15(g) of the
Securities Exchange Act of 1934, as amended (the Exchange Act). These rules
require, among other things, that brokers who trade penny stock 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.
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 compounds 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 approximately $9,000 per month.
During the fourth quarter of fiscal 2010, we commenced the process of closing our Tempe,
Arizona corporate office and consolidating our corporate administrative functions to our
headquarters in Baltimore, Maryland. In April, 2010, we executed a sublease for the Tempe office
space with an independent third party for $3,050 per month for the remaining term of the lease.
Item 3. Legal Proceedings.
None.
12
Table of Contents
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 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. High and low closing prices for our common stock for the last
two fiscal years were:
Fiscal 2010 | High | Low | ||||||
First Quarter |
$ | 1.07 | $ | 0.76 | ||||
Second Quarter |
0.95 | 0.55 | ||||||
Third Quarter |
0.95 | 0.65 | ||||||
Fourth Quarter |
1.10 | 0.75 |
Fiscal 2009 | High | Low | ||||||
First Quarter |
$ | 1.40 | $ | 0.60 | ||||
Second Quarter |
1.15 | 0.25 | ||||||
Third Quarter |
1.19 | 0.33 | ||||||
Fourth Quarter |
1.25 | 0.71 |
Approximate Number of Holders of Common Stock
As of
July 28, 2010, there were approximately 2,144 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
Table of Contents
Recent Sales by the Company of Unregistered Securities
From December, 2009, though April, 2010, the Company received gross proceeds of $2,250,000
from the private placement of 3,000,000 shares of the Companys unregistered common stock. This
unregistered common stock was sold to accredited investors exempt from registration as provided by
Section 4(2) of the Securities Act of 1933 and Regulation D. The Company incurred
approximately $28,000 in direct and incremental costs related to the offering. Also, during the
fourth quarter of fiscal 2010 the Company executed additional subscription agreements for the
private placement of unregistered common stock noted above totaling $750,000.
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
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 agreements with United States based preclinical CROs.
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 Tumorgraft studies 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, 2010, we continued to expand our Biomerk Tumorgraft models and
related testing service offerings. Fiscal 2010 was the first full year that we were able to offer
leading pharmaceutical and biotechnology companies the full benefits of our Biomerk Tumorgrafts for
their preclinical evaluation programs. We provide Preclinical eValuation services that we believe
are more predictive of clinical outcomes and that might provide for a faster and less expensive
path to drug approval. These services utilize Biomerk Tumorgrafts to evaluate tumor
sensitivity/resistance to various single, 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 oncology drug
compounds and to
develop a portfolio of drug compounds through pre-clinical trials. As drugs progress through this
early stage of development, the Company plans to sell, partner or license such drugs to
pharmaceutical and/or
biotechnology companies. We believe this strategy will enable the Company to leverage the
competencies of these partners or licensees 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, which requires a very large financial
commitment and a long development period, typically more than a decade, to commercialize. Thus far
we have acquired four drug compounds: BPU, TAR-1, Bithionol, and Irinophore C, through purchase,
exclusive worldwide licensing and/or option agreements. Of our four drug compounds, we have begun
preclinical testing of three and expect to start testing the fourth
compound in the first or
second quarter of fiscal 2011.
Results of Operations Comparing Fiscal Years ended April 30, 2010 and April 30, 2009
Operating Revenues:
For the fiscal years
ended April 30, 2010 and 2009, the Companys revenues from operations
were $4,893,000, and $3,710,000, respectively, an increase for the
2010 period of $1,183,000 or 32%. The increase
was comprised of $1,255,000 increase from our PCE services, which began generating revenues during fiscal 2009, partially offset by a
$72,000 a decrease from POS.
Revenues generated in our POS business related to Personalized Oncology Panels, Tumorgraft
implantations and related Tumorgraft studies. Our POS revenues experienced a 2% decline during fiscal 2010. The
increase in our PCE services is attributable to a greater demand and the completion of a
number of PCE contracts during fiscal 2010. Contracts for our PCE services may take up to one or
more years to complete.
Costs and Operating Expenses:
For
the fiscal years ended April 30, 2010 and 2009, the Companys costs and operating expenses
were $7,821,000 and $6,040,000, respectively, an increase for the
period of $1,781,000 or 29%.
Cost of Personalized Oncology Services (CPOS) for the fiscal years ended April 30,
2010 and 2009 were $1,181,000 and $1,623,000, respectively, a decrease of $442,000 or 27%. Of this
decrease, $237,000 is due to the realization of increased gross margins on POS services in fiscal
2010 and one-time credits with vendors who performed services for the Company totaling $205,000.
Cost of Preclinical eValuation
services for the fiscal years ended April 30, 2010 and 2009
were $798,000 and $285,000, respectively, an increase for the period of $513,000 or 180%. Costs of PCE services
as a percentage of PCE revenues declined from 66% to 47% of PCE
revenues primarily as a result of increased efficiencies during
PCEs second full year of operations. Additionally, during
fiscal 2009, the Company negotiated a reduction in the sales amount
of a contract with one of our customers in exchange for future royalties on that contract. To date no royalties have been
realized on that contract.
Research and Development expenses
for the fiscal years ended April 30, 2010 and 2009 were
$2,695,000 and $1,721,000, respectively, an increase for the period
of $974,000 or 57%. The increase was mainly
attributable a combined charge of $553,000 for licensing fees, option rights, and other costs
incurred to license and/or acquire additional drug compounds,
and an increase of $504,000 for
the acquisition of Tumorgrafts and other research and development
testing costs, offset by the
cancelation of an amount payable of $83,000 to certain vendors for lack of performance.
Impairment of Intangible Assets expense for the fiscal year ended April 30, 2009 was $284,000
due to the impairment of certain patent rights. We identified indicators of impairment based on
changes in current market conditions for potential partnering and licensing opportunities in this
patent right, and performed an impairment analysis which concluded that the carrying amount of the
patent rights was greater than the assets fair value, based on assumed cash outflow to be
generated from this asset.
15
Table of Contents
General and Administrative expenses for the fiscal years ended April 30, 2010 and 2009, were
$3,147,000 and $2,127,000, respectively, an increase of $1,020,000 or 48%. The increase was due to
the expansion of our management team and infrastructure to meet the requirements of a public
company. Additionally, the Company incurred additional administrative expenses of approximately
$126,000 to establish a U.K. subsidiary and branch operations in Israel.
Interest Income decreased from $88,000 in the year ended April 30, 2009 to $5,000 in fiscal
2010. The decrease in interest income resulted from the Companys decrease in assets held in
interest bearing investments.
Net Loss:
The Companys net loss for the year ended April 30, 2010
was $2,923,000, an increase of
$681,000, as compared to a net loss of $2,242,000 for the fiscal year ended April 30, 2009, due to
the factors discussed above.
Liquidity and Capital Resources
The Companys available liquid capital as of April 30, 2010 amounted to cash of $2,572,000 as
compared to $2,745,000 (consisting of cash and cash equivalents of $1,728,000 and a certificate of
deposit of $1,017,000) on April 30, 2009. In June, 2009, the certificate of deposit matured and
was converted to cash.
For the
year ended April 30, 2010, net cash used in operations was
$2,100,000 compared to
$888,000 used in operations during the year ended April 30,
2009. The increase of $1,212,000 in
cash used in operations from prior year is due to the $681,000 increase in our net loss, the net
$601,000 increase in cash used due to the changes in operating assets and liabilities, and a
decrease of $284,000 for the impairment of an intangible assets, offset by a $129,000 increase in
share-based compensation, a $175,000 charge for common stock issued for a patent, a $22,000 loss on
the disposal of assets, and a $28,000 increase in depreciation expense.
For the
year ended April 30, 2010, net cash provided by investing
activities was $941,000
compared to $1,150,000 used in investing activities during the year ended April 30, 2009. The
$2,091,000 increase in cash provided by investing activities was due to the redemption of a
certificate of deposit for $1,107,000, a $64,000 decrease in the purchase of intangible and other
assets, and the receipt of $8,000 from the sale of property and
equipment, offset by a $15,000 increase in the purchase of property and
equipment. In June, 2009, the
certificate of deposit matured and was converted to cash.
For the years ended April 30, 2010 and 2009, net cash provided by financing activities was
$2,007,000 and $57,000, respectively. The $1,950,000 increase was due to the $2,222,000 in cash
provided by a private placement of common stock, offset by $218,000 in purchases of treasury stock
and a $54,000 decrease in cash provided by the exercise of stock options and warrants.
The Companys working capital as
of April 30, 2010 and 2009 was $1,068,000 and $1,166,000,
respectively.
In May 2009, our 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 consulting agreement
executed in conjunction with the stock repurchase agreement. Under the agreement, the Company will
repurchase shares of common 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 as long as the consulting
agreement remains in effect. The Company may purchase up to 2,250,000 shares of the common stock
at the discretion of the Company subject to the above commitment and pricing formula. During the
year ended April 30, 2010, the Company purchased 474,289 shares of our common stock from the Board
member for approximately $218,000. In
May 2010, the Company repurchased an additional 77,962 shares of our common stock for $31,250
per the terms of the repurchase agreement noted above.
16
Table of Contents
In June 2009, the Companys Board of Directors authorized management to begin the process of
raising additional capital. From December 2009 through April, 2010, the Company received gross
proceeds of $2,250,000 from the private placement of 3,000,000 shares of the Companys unregistered
common stock. This unregistered common stock was sold to accredited investors exempt from
registration as provided by Section 4(2) of the Securities Act of 1933 and Regulation D. The
Company incurred approximately $28,000 in direct and incremental costs related to the offering.
Additionally, the Company has executed subscription agreements for the private placement of
unregistered common stock noted above totaling $750,000.
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.
Critical Accounting Policies
Revenue Recognition. The Company derives revenue from Personalized Oncology and
Preclinical eValuation services. Personalized 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 following four basic criteria
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 remitted 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 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, (3) if we have given the customer a general right of return relative
to the delivered item(s), and (4) 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 contract.
Stock-Based
Payments. The Company typically recognizes expense for share-based
payments based on the fair value of awards on the date of grant. The Company uses 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. These assumptions are
based on historical information and management judgment. The Company expenses stock-based payments
over the period that the awards are expected to
vest, net of estimated forfeitures. If the actual forfeitures differ from managements
estimates, compensation expense is adjusted. 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.
17
Table of Contents
Research and Development. Research
and development costs represent both costs
incurred internally for research and development activities, costs of
licensing drug compounds as well as costs incurred externally to
fund research activities. All research and development costs are expensed as incurred.
Non-refundable advance payments are capitalized and recorded as expense when the respective product
or services are delivered.
Item 8. Financial Statements and Supplementary Data.
Consolidated balance sheets as of April 30, 2010 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, 2010 together with the report of our independent registered public accounting firm,
are set forth in the F pages of this Annual Report on Form 10-K.
Item 9. Changes In and Disagreements With Accountants on Accounting and Financial Disclosure.
None.
Item 9A(T). Controls and Procedures.
Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures
Our
management, with the participation of our Acting Executive Officer/Chief Financial
Officer, have reviewed and evaluated our disclosure controls and procedures (as defined in the
Securities Exchange Act Rule 13a-15(e)) as of the end of the period covered by this Form 10-K.
Based on that evaluation, our management, including our Acting
Executive Officer/Principal
Financial Officer, has concluded that our disclosure controls and procedures were
effective as of the end of the period covered by this Form 10-K in ensuring that information
required to be disclosed in the reports that we file or submit under the Securities Exchange Act of
1934 is recorded, processed, summarized and reported within the time periods specified in the
Securities and Exchange Commissions rules and forms and is accumulated and communicated to
management, including our Acting Executive Officer/Principal Financial
Officer, as appropriate, to allow timely decisions regarding required disclosure.
Managements Annual Report on Internal Control Over Financial Reporting
The management of Champions Biotechnology, Inc. is responsible for establishing and
maintaining adequate internal control over financial reporting, as such term is defined in Exchange
Act Rule 13a15(f). Under the supervision and with the participation of our management, including
our Acting Executive Officer/Principal Financial Officer, we conducted an evaluation of the
effectiveness of our internal control over financial reporting based on the framework in Internal
ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission. Based on our evaluation under the framework in Internal ControlIntegrated Framework,
our management concluded that our internal control over financial reporting was effective as of
April 30, 2010.
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 registered public
accounting firm pursuant to temporary rules of the Securities Exchange Commission that permit the
Company to provide only managements report in this annual report.
18
Table of Contents
Managements Annual Report on Changes in Internal Controls
There were no changes in our internal controls over financial reporting during the quarter
ended April 30, 2010, that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
Item 9B. Other Information.
During the fourth quarter of fiscal 2010, we commenced the process of closing our Tempe,
Arizona corporate office and consolidating our corporate administrative functions to our
headquarters in Baltimore, Maryland. In April, 2010, we executed a sublease for the Tempe office
space with an independent third party for the remaining term of the lease and accrued a charge of
approximately $36,000 for costs of moving the corporate office to Baltimore. This charge is net of
monthly sublease income of approximately $3,000. The Company also incurred a loss of approximately
$22,000 relative to certain equipment that will be disposed of as part of this relocation.
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, 2010 are as follows:
Name | Position(s) Presently Held | |
David Sidransky, M.D.
|
Chairman | |
Mark R. Schonau
|
Acting Principle Executive Officer and Chief Financial Officer | |
James M. Martell
|
Director | |
Abba David Poliakoff
|
Director | |
Ana I. Stancic
|
Director |
David Sidransky, M.D., age 50, 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, Chairman of Alfacell Corporation and serves on the
Rosetta Genomics Medical Advisory Board. 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.
Dr.
Sidransky is well qualified to serve as non-executive Chairman of the
Company and a member of the Companys Board based on his extensive experience in clinical and medical oncology, his stature as a leading researcher in the field, and his experience with biotechnology companies.
19
Table of Contents
Mark R. Schonau, age 53 has served as Chief Financial Officer since January, 2009, and Acting
Principal Executive Officer since January, 2010. Mr. Schonau has more than twenty-five years of
leadership in financial and operations management. 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 related
side effects. 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 American Institutes
of Certified Public Accountants, Arizona Society 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 63, 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 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 United States 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.
Mr. Martell is well qualified to serve as a member of the Companys Board due to his prior experience as a Public Company Chairman, President and Chief Executive Officer.
Abba David Poliakoff, age 58, 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. He is a member of the Maryland State Bar Associations Business Law
Section, former Chair of its Committee on Securities, and a former, member of the Business
Regulations Article Review Committee of the Committee to Revise the Maryland Annotated Code. Mr.
Poliakoff is also a member of the Board of Directors of the Greater Baltimore Technology Council
(GBTC). 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.
Mr. Poliakoff is well qualified to serve as a member of the Companys Board due to his extensive legal experience and experience with biotechnology start-ups.
20
Table of Contents
Ana I. Stancic, age 53, has over twenty years of extensive and diversified finance, accounting and
operational experience in the healthcare industry. She is currently Senior Vice President and
Chief Financial Officer of M2Gen, a wholly owned for-profit subsidiary of Moffitt Cancer Center.
From 2008 to 2009, she served as Chief Financial Officer of Aureon Laboratories, Inc., a private
oncology diagnostic company. From 2007 to 2008, she was Executive Vice President and Chief
Financial Officer at Omrix
Biopharmaceuticals, Inc., which was acquired by Johnson and Johnson. From 2004 to 2007, Ms.
Stancic was at ImClone Systems, Inc., which was acquired by Eli Lilly, Inc. At Imclone, she served
in various financial roles, including Senior Vice President, Finance. Prior to joining ImClone,
she was Vice President and Controller at Savient Pharmaceuticals, Inc. Ms. Stancic began her career
at PricewaterhouseCoopers in the Assurance practice where she had responsibility for 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 University Graduate School of Business.
She also serves as a member of the Board of Directors of KV Pharmaceutical Co.
Ms. Stancic is well qualified to serve as a member of the Companys board due to
her extensive finance, accounting and operational experience in the healthcare industry.
Ms. Stancic is also the Audit Committees financial expert.
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.
The Board of Directors met 10 times during the fiscal year ended
April 30, 2010. No incumbent director attended fewer than 75% of the
total number of meetings of the Board of
Directors held during 2010 and the total number of meetings held by all committees on which the director served during such year.
Board Independence
The Board has determined that each of the current directors is independent within the meaning of the
Companys director independence standards, which reflect both the NASDAQ and SEC director independence
standards, as currently in effect. Furthermore, the Board has determined that none of the members of the three
standing committees of the Board of Directors in existence during the 2010 fiscal year, has any material relationship with the Company
(either directly or as a partner, stockholder or officer of an organization that has a relationship
with the Company) and that each such member is independent within the meaning of the independence
standards applicable to each such committee.
Leadership Structure and Risk Oversight
While the Board believes that there are various structures which can provide successful leadership
to the Company, we currently have separate individuals serving in
the roles of Chairman of the Board
and Chief Executive Officer in recognition of the differences between the two roles. The CEO is responsible
for setting the strategic direction for the Company and the day-to-day leadership of the Company, while the
Chairman of the Board provides guidance to the CEO and presides over meetings of the full Board. This structure
is appropriate at this time to the Companys business because it reflects the industry experience, vision
and energy brought to the Board of Directors by the Chairman, Dr. Sidransky, and the day-to-day management
direction of the Company under our CEO.
Management is responsible for the day-to-day management of risks the Company faces, while the Board,
as a whole and through its committees, has responsibility for the oversight of risk management. In its risk
oversight role, the Board of Directors has the responsibility to satisfy itself that the risk management process
designed and implemented by management are adequate and functioning
as designed. To do this, the Chairman of
the Board meets regularly with management to discuss strategy and the
risks facing the Company. Senior management
attends the Board meetings and is available to address any questions or concerns raised by the Board on risk management
and any other matters. The Chairman of the Board and independent members of the Board work together to provide strong,
independent oversight of the Companys management and affairs through its standing committees and, when necessary,
special meetings of independent directors.
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
Abba David Poliakoff
Ana Stancic
David Sidransky, Chair
Abba David Poliakoff
Ana Stancic
Compensation Committee
Abba David Poliakoff, Chair
David Sidransky
Ana Stancic
Abba David Poliakoff, Chair
David Sidransky
Ana Stancic
Audit Committee
Ana Stancic, Chair
Abba David Poliakoff
David Sidransky
Ana Stancic, Chair
Abba David Poliakoff
David Sidransky
Code of Ethics
The Company has a Code of Ethics that applies to all Company employees, including the Chief
Financial Officer, as well as members of the Board of Directors. The Companys Code of Ethics has been
filed as Exhibit 14 to the Companys Annual Report on Form
10-KSB for the year ended April 30, 2008.
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.
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 $100,000 in total compensation in the fiscal year ended
April 30, 2010.
21
Table of Contents
SUMMARY COMPENSATION TABLE
Option | Restricted | |||||||||||||||||||
Name and Principal Position | Year | Salary ($) | Awards ($) | Stock ($) | Total ($) | |||||||||||||||
Dr. Douglas D. Burkett,
former
|
2010 | 150,000 | (1) | | | 150,000 | ||||||||||||||
Principal Executive
Officer |
2009 | 225,000 | | | 225,000 | |||||||||||||||
Mark R. Schonau, Acting |
2010 | 185,000 | | 6,565 | (2) | 191,565 | ||||||||||||||
Principal Executive
Officer and
Chief Financial Officer |
2009 | 53,958 | (3) | 212,616 | | 266,574 |
(1) | Resigned from CEO position
effective December 31, 2009. |
|
(2) | Restricted stock awarded on August 28, 2009, vesting evenly over three years, 0 shares
vested as of April 30, 2010. |
|
(3) | Reflects salary
commencing with Mr. Schonaus 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, former 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.
In December 2009, Mr. Burkett resigned his position as Principle Executive Officer but agreed
to serve as a consultant to the Company through July 2010. In conjunction with his amended
employment agreement the Company accelerated his 166,670 unvested stock options to December 31,
2009.
Mark R. Schonau, Acting Principal Executive Officer and 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 $1.18 per share, the market price of the common stock on the date the
options were approved by the Companys Board of Directors. The options to purchase shares vest at
the rate of 77,666 shares on the first anniversary of the grant date, 77,667 shares on the second
anniversary of the grant date and 77,667 on the third anniversary of the grant date. All vested
options will be exercisable over a seven-year period beginning on the third anniversary of the
grant date. The agreement further provides that if the Company terminates the executives
employment without cause, the Company shall pay the executive severance equal to three months
salary.
22
Table of Contents
The following table sets forth, for each of the executive officers named in the Summary
Compensation Table, information with respect to unexercised options as of the Companys fiscal year
ended April 30, 2010:
Number of | Number of | |||||||||||||||
Securities | Securities | |||||||||||||||
Underlying | Underlying | |||||||||||||||
Unexercised | Unexercised | Option | Option | |||||||||||||
Options (#) | Options (#) | Exercise | Expiration | |||||||||||||
Name | Exercisable | Un-exercisable | Price ($) | Date | ||||||||||||
Douglas D. Burkett
(1) |
500,000 | | 0.75 | 10/10/2012 | ||||||||||||
Mark R.
Schonau
(2) |
77,666 | 155,334 | 1.18 | 2/23/2019 |
(1) | In conjunction with Mr. Burketts resignation as Principle Executive Officer in December,
2009, the Company accelerated the vesting of 166,670 of Mr. Burketts unvested stock
options to December 31, 2009. |
|
(2) | These options to purchase shares vest at the rate of 77,666 shares on the grant anniversary and
then 77,667 shares on each of the second and third 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. |
DIRECTOR COMPENSATION
In the fiscal year ended April 30, 2010, the Board of Directors adopted the Director
Compensation Plan of 2010 (the Director Plan) to replace the Companys former compensation policy
for directors, effective for the 2010 calendar year commencing January 1, 2010.
Under the Director Plan, on January 1 of each year, each independent director, other than the
Chairman, will be granted an automatic award of five-year options to purchase 50,000 shares of the
Companys Common Stock, par value $0.001 per share pursuant to the Companys 2008 Equity Incentive
Plan, at an exercise price equal to the last closing price of the shares prior to the effective
date of the grant. The Chairman will be granted an automatic annual award of five-year options to
purchase 100,000 shares pursuant to the Plan at an exercise price equal to the last closing price
of the shares prior to the effective date of the grant. All of the options vest quarterly at the
rate of 25% each calendar quarter over that calendar year, commencing on the first day of each
calendar quarter.
In addition, for service on one or more Board committees, independent directors will receive
on the first day of each calendar year either a grant of five-year options to purchase 50,000
shares at an exercise price equal to the last closing price of the shares prior to the effective
date of the grant, or, at the election of the director, 50,000 restricted shares. The Chairman
will receive for his committee service, on the first day of each calendar year, either a grant of
five-year options to purchase 100,000 shares at an exercise price equal to the last closing price
of the shares prior to the effective date of the grant, or, at the election of the director,
100,000 restricted shares. All of these option awards and share grants vest quarterly at the rate
of 25% throughout the calendar year on the first day of each calendar quarter, commencing on
January 1 of each calendar year.
The Company will also pay each independent director $15,000 to offset the tax liability in
respect of a restricted shares award, paid 25% each quarter.
23
Table of Contents
The following table summarizes the compensation paid to directors for the fiscal years ended
April 30, 2010 and 2009:
2010 | 2010 | 2010 | 2009 | |||||||||||||
Board Member | Cash Awards ($) | Option Awards ($) | Total Award | Awards ($) (1) | ||||||||||||
David Sidransky |
$ | | $ | 158,000 | $ | 158,000 | $ | | ||||||||
Abba David Poliakoff |
7,500 | 57,000 | 64,500 | | ||||||||||||
Ana Stancic |
26,750 | 57,000 | 83,750 | | ||||||||||||
James Martell |
| | | |
The above option award values were calculated using the Black-Scholes valuation method (see
Note 6 to the Consolidated Financial Statements included herein).
(1) | There were no cash or option payments to directors in the fiscal year ended April 30, 2009. |
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
As
of July 28, 2010, the following were persons known to the Company to own beneficially more
than 5% of the Companys outstanding Common Stock:
Common Stock | Percent | |||||||
Name and Address of Beneficial Owner | Beneficially Owned (1) | of Class | ||||||
David Sidransky, M.D. |
10,726,666 | 30.0 | ||||||
1550 Orleans Street Baltimore, MD 21231 |
||||||||
James M. Martell |
7,245,749 | 20.3 | ||||||
1400 N. 14th Street Arlington, VA 22209 |
||||||||
Manuel
Hildalgo, M.D., Ph.D. |
3,125,000 | 8.8 | ||||||
206 Cross Street Baltimore, MD 21230 |
(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. |
As
of July 28, 2010, 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 | 10,726,666 | 30.0 | |||||||
Douglas D Burkett, Ph.D. |
Former Principal Executive Officer | 500,000 | 1.4 | |||||||
Mark R. Schonau |
Acting Principal Executive Officer and Chief Financial Officer | 77,666 | 0.2 | |||||||
James M. Martell |
Director | 7,245,749 | 20.3 | |||||||
Abba David Poliakoff |
Director | 666,666 | 1.9 | |||||||
Ana I. Stancic |
Director | 58,333 | 0.2 | |||||||
All Officers and Directors
as a group |
19,275,080 | 54.0 | ||||||||
(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. |
24
Table of Contents
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, 2010, 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, | options, | securities reflected in | ||||||||||
and rights | and rights | column (a) | ||||||||||
Plan Category | (a) | (b) | (c) | |||||||||
Equity compensation
plans approved by
shareholders |
| $ | | | ||||||||
Equity compensation
plans not approved
by shareholders |
3,317,948 | 0.77 | | |||||||||
Total |
3,317,948 | $ | 0.77 | | ||||||||
Item 13. Certain Relationships and Related Transactions.
During the fiscal years ended April 30, 2010 and 2009, we paid one of our directors and former
CEO, James Martell, $103,593, and $185,000, respectively, in salaries and consulting fees,
respectively. Additionally, during the fiscal year ended April 30, 2009, we paid this director
approximately $361,000 for accrued salaries payable to him outstanding as of April 30, 2008. No
amounts were outstanding as of April 30, 2010. We also reacquired 474,289 shares of our common
stock for $218,000 from Mr. Martell during fiscal 2010.
During the years ended April 30, 2010 and April 30, 2009, the Company paid our Chairman, David
Sidransky, $20,000 and $105,000, respectively, for consulting services.
During the fiscal year ended April 30, 2010 we paid a director, Ana Stancic $15,000 for
consulting services.
During the fiscal years ended April 30, 2010 and 2009, we paid a significant shareholder
approximately $180,000 each year for consulting services.
25
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, 2010, and April 30, 2009:
Fee Category | 2010 | 2009 | ||||||
Audit and related fees |
$ | 178,000 | $ | 38,000 | ||||
Tax fees |
10,000 | 5,000 | ||||||
All other fees |
| | ||||||
Total fees |
$ | 188,000 | $ | 43,000 | ||||
Audit and related fees: Consists of fees for professional services rendered by our principal
accountants for the audit of the annual financial statements and 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 audit and 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.
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 Report of its Independent
Registered Public Accounting Firm are presented in the F pages of this report: |
||
Report of Independent Registered Public Accounting Firm. |
||
Consolidated Balance Sheets April 30, 2010 and 2009. |
||
Consolidated Statements of Operations Each of the years in the two-year period ended
April 30, 2010. |
||
Consolidated Statements of Stockholders Equity Each of the years in the two-year period
ended April 30, 2010. |
||
Consolidated Statements of Cash Flows Each of the years in the two-year period ended
April 30, 2010. |
||
Notes to Consolidated Financial Statements. |
26
Table of Contents
2. | All management contracts and compensatory plans and arrangements are
specifically identified on the attached Exhibit Index. |
(b) | Exhibits |
See the Exhibit Index following the signature page of this report, which Index is
incorporated herein by reference. |
(c) | Financial Statements and
Schedules See Item 15(a)(1) and Item 15(a)(2) above. |
27
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/ Mark R. Schonau | |||
Mark R. Schonau | ||||
Acting Principal Executive
Officer Date: July 28, 2010 |
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 and Acting Principal Executive Officer Date: July 28, 2010 |
||||
By: | /s/ David Sidransky | |||
David Sidransky | ||||
Chairman Director Date: July 28, 2010 |
||||
By: | /s/ James M. Martell | |||
James M. Martell | ||||
Director Date: July 28, 2010 |
By: | /s/ Abba D. Poliakoff | |||
Abba D. Poliakoff | ||||
Director Date: July 28, 2010 |
||||
By: | /s/ Ana I. Stancic | |||
Ana I. Stancic | ||||
Director Date: July 28, 2010 |
28
Table of Contents
Exhibits No.
3.1 | Articles of Incorporation (incorporated by reference to Exhibit 3.1
of the April 30, 2009 Form 10-K, File No. 0-17263 ) |
|||
3.2 | Bylaws, as amended (incorporated by reference to Exhibit 3.2 of the
April 30, 2009 Form 10-K, File No. 0-17263) |
|||
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-K, File No. 0-17263) |
|||
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-K, File No. 0-17263) |
|||
10.4 | Employment Agreement dated January 5, 2009 between the Company and
Mark R. Schonau (incorporated by reference to Exhibit 10.4 of the
April 30, 2009 Form 10-K, File No. 0-17263) |
|||
10.5 | Consulting agreement dated May 18, 2009 between the Company and James
Martell (incorporated by reference to Exhibit 10.5 of the April 30,
2009 Form 10-K, File No. 0-17263) |
|||
10.6 | Stock
Repurchase Agreement dated May 18, 2009 between the Company and James
Martell (incorporated by reference to Exhibit 10.6 of the April 30,
2009 Form 10-K, File No. 0-17263) |
|||
14 | Code of Ethics (incorporated by reference to Exhibit 14 of the April
30, 2008 Form 10-KSB, File No. 0-17263) |
|||
21 | Subsidiaries of the Registrant (incorporated by reference to Exhibit
21 of the April 30, 2009 Form 10-K, File No. 0-17263) |
|||
31.1 | Rule 13a-14(a)/15d-14(a) Certification of Principle Executive Officer* |
|||
31.2 | Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer* |
|||
32.1 | Section 1350 Certifications* |
* | Filed herewith. |
29
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
APRIL 30, 2010 AND 2009
Page | ||||
CONSOLIDATED FINANCIAL STATEMENTS: |
||||
F-2 | ||||
F-3 | ||||
F-4 | ||||
F-5 | ||||
F-6 | ||||
F-7F-21 |
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 sheets of Champions Biotechnology, Inc. (the Company), as of
April 30, 2010 and 2009, and the related consolidated statements of operations, stockholders equity, and cash flows
for each of the two years in the period ended April 30, 2010. The consolidated financial statements are the
responsibility of the Companys management. Our responsibility is to express an opinion on these consolidated
financial statements based on our audits.
We conducted our audits 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 audits 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
audits provide 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, 2010 and 2009 and the consolidated
results of its operations and its cash flows for each of the two years ended April 30, 2010 in conformity with United
States generally accepted accounting principles.
As discussed in Note 1 to the consolidated financial statements, 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 July 28, 2010 |
F-2
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
CONSOLIDATED BALANCE SHEETS
April 30, | ||||||||
2010 | 2009 | |||||||
ASSETS |
||||||||
CURRENT ASSETS |
||||||||
Cash and cash equivalents |
$ | 2,572,000 | $ | 1,728,000 | ||||
Short term investments |
| 1,017,000 | ||||||
Accounts receivable |
46,000 | | ||||||
Prepaid expenses, deposits, and other |
540,000 | 1,125,000 | ||||||
Total current assets |
3,158,000 | 3,870,000 | ||||||
Property and equipment, net |
105,000 | 81,000 | ||||||
Goodwill |
669,000 | 669,000 | ||||||
Total assets |
$ | 3,932,000 | $ | 4,620,000 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
CURRENT LIABILITIES |
||||||||
Accounts payable |
$ | 944,000 | $ | 1,414,000 | ||||
Accrued liabilities |
236,000 | 67,000 | ||||||
Deferred revenue |
910,000 | 1,223,000 | ||||||
Total current liabilities |
2,090,000 | 2,704,000 | ||||||
Other liabilities |
77,000 | | ||||||
Total liabilities |
2,167,000 | 2,704,000 | ||||||
COMMITMENTS AND CONTINGENCIES |
||||||||
Accrued stock purchase |
188,000 | | ||||||
STOCKHOLDERS EQUITY |
||||||||
Preferred stock, $10 par value; 56,075 shares authorized;
0 shares issued and outstanding |
| | ||||||
Common stock, $.001 par value; 50,000,000 shares authorized;
36,844,000 and 33,579,000 issued at April 30, 2010 and 2009, respectively
and 35,780,000 and 32,989,000 shares outstanding as of April 30, 2010
and 2009, respectively |
37,000 | 34,000 | ||||||
Treasury stock, at cost, 1,064,000 and 590,000 shares at April 30, 2010
and 2009, respectively |
(219,000 | ) | (1,000 | ) | ||||
Stock subscription receivable |
(750,000 | ) | | |||||
Additional paid-in capital |
15,193,000 | 11,640,000 | ||||||
Accumulated deficit |
(12,680,000 | ) | (9,757,000 | ) | ||||
Accumulated other comprehensive income |
(4,000 | ) | | |||||
Total stockholders equity |
$ | 1,577,000 | $ | 1,916,000 | ||||
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY |
$ | 3,932,000 | $ | 4,620,000 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
F-3
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
Year Ended April 30, | ||||||||
2010 | 2009 | |||||||
OPERATING REVENUE |
||||||||
Personalized oncology services |
$ | 3,206,000 | $ | 3,278,000 | ||||
Preclinical eValuation services |
1,687,000 | 432,000 | ||||||
Total operating revenue |
4,893,000 | 3,710,000 | ||||||
COSTS AND OPERATING EXPENSES |
||||||||
Cost of Personalized oncology services |
1,181,000 | 1,623,000 | ||||||
Cost of Preclinical eValuation services |
798,000 | 285,000 | ||||||
Research and development |
2,695,000 | 1,721,000 | ||||||
Impairment of intangible asset |
| 284,000 | ||||||
General and administrative |
3,147,000 | 2,127,000 | ||||||
Total costs and operating expenses |
7,821,000 | 6,040,000 | ||||||
LOSS BEFORE OTHER INCOME |
(2,928,000 | ) | (2,330,000 | ) | ||||
Interest income |
5,000 | 88,000 | ||||||
LOSS BEFORE PROVISION FOR INCOME TAXES |
(2,923,000 | ) | (2,242,000 | ) | ||||
Provision for income taxes |
| | ||||||
NET LOSS |
$ | (2,923,000 | ) | $ | (2,242,000 | ) | ||
NET LOSS PER SHARE BASIC AND DILUTED |
$ | (0.09 | ) | $ | (0.07 | ) | ||
WEIGHTED AVERAGE SHARES OUTSTANDING
BASIC AND DILUTED |
33,774,000 | 33,266,000 | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-4
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
Accumulated | ||||||||||||||||||||||||||||||||||||
Stock | Other | |||||||||||||||||||||||||||||||||||
Common Stock | Treasury Stock | Additional | Accumulated | Subscription | Comprehensive | Total | ||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Paid-in Capital | Deficit | Receivable | Income (Loss) | Equity | ||||||||||||||||||||||||||||
Balance at
May 1, 2008 |
33,248,000 | $ | 33,000 | 90,000 | $ | | $ | 11,119,000 | $ | (7,515,000 | ) | $ | | $ | | $ | 3,637,000 | |||||||||||||||||||
Net loss |
| | | | | (2,242,000 | ) | | | (2,242,000 | ) | |||||||||||||||||||||||||
Stock-based compensation expense |
| | | | 464,000 | | | | 464,000 | |||||||||||||||||||||||||||
Warrants exercised for cash |
216,000 | 1,000 | | | 49,000 | | | | 50,000 | |||||||||||||||||||||||||||
Stock returned by officer |
(500,000 | ) | | 500,000 | (1,000 | ) | 1,000 | | | | | |||||||||||||||||||||||||
Options exercised for cash |
25,000 | | | | 7,000 | | | | 7,000 | |||||||||||||||||||||||||||
Balance at April 30, 2009 |
32,989,000 | 34,000 | 590,000 | (1,000 | ) | 11,640,000 | (9,757,000 | ) | | | 1,916,000 | |||||||||||||||||||||||||
Net loss |
| | | | | (2,923,000 | ) | | | (2,923,000 | ) | |||||||||||||||||||||||||
Foreign currency translation
adjustment |
| | | | | | | (4,000 | ) | (4,000 | ) | |||||||||||||||||||||||||
Comprehensive income |
| | | | | | | | (2,927,000 | ) | ||||||||||||||||||||||||||
Stock-based compensation expense |
| | | | 593,000 | | | | 593,000 | |||||||||||||||||||||||||||
Warrants exercised for cash |
15,000 | | | | 3,000 | | | | 3,000 | |||||||||||||||||||||||||||
Private placement of common
stock for cash, net issuance
costs of $28,000 |
3,000,000 | 3,000 | | | 2,969,000 | | | | 2,972,000 | |||||||||||||||||||||||||||
Stock subscription receivable |
| | | | | | (750,000 | ) | | (750,000 | ) | |||||||||||||||||||||||||
Common stock issued for patent |
250,000 | | | | 175,000 | | | | 175,000 | |||||||||||||||||||||||||||
Purchase of treasury stock from
board member |
(474,000 | ) | | 474,000 | (218,000 | ) | (187,000 | ) | | | | (405,000 | ) | |||||||||||||||||||||||
Issuance of purchased call to
board member |
| | | | (1,774,000 | ) | | | | (1,774,000 | ) | |||||||||||||||||||||||||
Contribution of equity from
board member |
| | | | 1,774,000 | | | | 1,774,000 | |||||||||||||||||||||||||||
Balance at April 30, 2010 |
35,780,000 | $ | 37,000 | 1,064,000 | $ | (219,000 | ) | $ | 15,193,000 | $ | (12,680,000 | ) | $ | (750,000 | ) | $ | (4,000 | ) | $ | 1,577,000 | ||||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-5
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year Ended April 30, | ||||||||
2010 | 2009 | |||||||
OPERATING ACTIVITIES |
||||||||
Net loss |
$ | (2,923,000 | ) | $ | (2,242,000 | ) | ||
Adjustments to reconcile net loss to net cash
used in operating activities: |
||||||||
Impairment of intangible assets |
| 284,000 | ||||||
Common stock issued for patent |
175,000 | | ||||||
Stock-based compensation expense |
593,000 | 464,000 | ||||||
Loss on disposal of assets |
22,000 | | ||||||
Depreciation |
32,000 | 4,000 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
(46,000 | ) | | |||||
Prepaid expenses, deposits, and other |
585,000 | (668,000 | ) | |||||
Accounts payable |
(471,000 | ) | 881,000 | |||||
Accrued liabilities |
169,000 | 32,000 | ||||||
Deferred revenue |
(313,000 | ) | 718,000 | |||||
Accrued salary due to officer |
| (361,000 | ) | |||||
Other liabilities |
77,000 | | ||||||
Net cash used in operating activities |
(2,100,000 | ) | (888,000 | ) | ||||
INVESTING ACTIVITIES |
||||||||
Proceeds from certificate of deposit |
1,017,000 | | ||||||
Purchase of certificate of deposit |
| (1,017,000 | ) | |||||
Purchase of property and equipment |
(84,000 | ) | (69,000 | ) | ||||
Proceeds from sale of property and equipment |
8,000 | | ||||||
Purchase of intangibles |
| (57,000 | ) | |||||
Other |
| (7,000 | ) | |||||
Net cash provided by (used in) investing activities |
941,000 | (1,150,000 | ) | |||||
FINANCING ACTIVITIES |
||||||||
Net proceeds from sale of unregistered common stock |
2,222,000 | | ||||||
Purchase of treasury stock |
(218,000 | ) | | |||||
Proceeds from exercise of options and warrants |
3,000 | 57,000 | ||||||
Net cash provided by financing activities |
2,007,000 | 57,000 | ||||||
Exchange rate effect on cash and cash equivalents |
(4,000 | ) | | |||||
NET INCREASE (DECREASE) IN CASH
AND CASH EQUIVALENTS |
844,000 | (1,981,000 | ) | |||||
CASH AND CASH EQUIVALENTS
BEGINNING OF YEAR |
1,728,000 | 3,709,000 | ||||||
CASH AND CASH EQUIVALENTS END OF YEAR |
$ | 2,572,000 | $ | 1,728,000 | ||||
SUPPLEMENTAL CASH FLOW INFORMATION: |
||||||||
Cash paid during the year for: |
||||||||
Income taxes |
$ | | $ | 7,000 | ||||
SUPPLEMENTAL DISCLOSURE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: |
||||||||
Stock subscription receivable |
$ | 750,000 | $ | | ||||
Purchases of property and equipment included in
accounts payable |
$ | 2,000 | $ | 15,000 |
The accompanying notes are an integral part of these consolidated financial statements.
F-6
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
APRIL 30, 2010 AND 2009
APRIL 30, 2010 AND 2009
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. 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. In March 2009, the Company formed Champions
Biotechnology U.K., 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. These consolidated
financial statements do not include any adjustments that might result from the outcome of this
uncertainty.
We evaluated subsequent events through the date the accompanying consolidated financial
statements were issued.
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 U.K., Limited. All material intercompany
transactions have been eliminated in consolidation.
The local currency of the Companys foreign operations is converted to United States currency
for the Companys consolidated financial statements for each period being presented. The Company is
subject to foreign exchange rate fluctuations in connection with the Companys international
operations.
Segment Reporting
The Company operates as a single operation, using core infrastructure that serves the oncology
needs of customers through both personalized oncology and preclinical services. 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.
During the fiscal year ended April 30, 2010, the Company recognized a $288,000 reduction in
expense as a result of certain obligations being canceled by various vendors that were previously
recognized.
F-7
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
Reclassifications
Prior
year salaries expense of $72,000 has been reclassified from Cost of PCE Services to General and
Administrative to conform to the current year presentation.
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 the Company has 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. Available-for-sale investments are carried at fair value as
determined by quoted market prices, with unrealized gains and losses reported as a component of
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, 2010 and 2009. Interest income and realized gains and
losses, using the specific identification method, are included in other income.
Fair Value of Financial Instruments
The carrying value of cash and cash equivalents, 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.
The fair value hierarchy promulgated by accounting principles generally accepted in the United
States (GAAP) gives the highest priority to quoted prices in active markets for 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 consisted 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 is 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, | ||||||||
2010 | 2009 | |||||||
Furniture and fixtures |
$ | 6,000 | $ | 26,000 | ||||
Computer equipment and software |
42,000 | 55,000 | ||||||
Laboratory equipment |
37,000 | 4,000 | ||||||
Software in-progress |
43,000 | | ||||||
Total property and equipment |
128,000 | 85,000 | ||||||
Less accumulated depreciation |
(23,000 | ) | (4,000 | ) | ||||
Property and equipment, net |
$ | 105,000 | $ | 81,000 | ||||
F-8
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
Depreciation expense was $32,000 and $4,000 for the fiscal years ended April 30,
2010 and 2009, respectively.
Goodwill
Goodwill represents the excess of the cost over the fair market value of the net assets
acquired including identifiable assets. We test goodwill for impairment annually at April 30 using
the two-step process. The first step is to screen for potential impairment, while the second step
measures the amount of the impairment, if any. The first step of the goodwill impairment test
compares the fair value of a reporting unit with its carrying amount, including goodwill. If the
fair value of the reporting unit exceeds its carrying value, goodwill is not impaired. If the
carrying value of the reporting units net assets, including goodwill, exceeds the fair value of
the reporting unit, then we determine the implied fair value of goodwill. If the carrying value of
goodwill exceeds its implied fair value, then an impairment of goodwill has occurred and an
impairment loss would be recognized for the difference between the carrying amount and the implied
fair value of goodwill as a component of operating income. The implied fair value of goodwill is
calculated by subtracting the fair value of tangible and intangible assets associated with the
reporting unit from the fair value of the unit.
We have one reporting unit and one operating segment. In determining fair value, we primarily
utilize the Companys market capitalization, which is determined based on the fair value of our
common stock. However, we may test the results of fair value under this method using (i)
discounted cash flows; (ii) operating results based on a comparative multiple of earnings or
revenues; (iii) offers from interested investors, if any; or (iv) appraisals. Additionally, there
may be instances where these alternative methods provide a more accurate measure or indication of
fair value.
In addition, we evaluate impairment if events or circumstances change between our annual
assessment, indicating a possible impairment. Examples of such events or circumstances include: (i)
a significant adverse change in legal factors or in the business climate; (ii) an adverse action or
assessment by a regulator; or (iii) a significant decline in our market capitalization as compared
to our book value.
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.
Personalized 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 following four basic criteria 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 remitted 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.
F-9
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
When a Personalized Oncology or Preclinical eValuation arrangement involves multiple elements,
the items included in the arrangement (deliverables) are evaluated 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, (3) if we have given the customer a general right of return relative
to the delivered item(s), and (4) 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 contract.
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 implantation revenues are primarily related to
consulting fees and laboratory expenses. Vaccines and study costs are primarily incurred from
contract research organizations that conduct the related studies.
Cost of Preclinical eValuation Services
Cost of preclinical eValuation services consists of costs related to Preclinical eValuation
revenues. Along with the internal cost of salaries directly related to Preclinical eValuation
services, costs consist primarily of charges from contract research organizations for conducting
the related clinical evaluation.
Research and Development
Research and development costs represent both costs incurred internally for research and
development activities as well as costs incurred externally to fund research activities. All
research and development costs are expensed as incurred. Non-refundable advance payments are
capitalized and recorded as expense when the respective product or services are determined.
Basic and Dilutive Loss Per Common Share
Basic earnings (loss) per share is calculated by dividing loss available to common
shareholders by the weighted average number of common shares outstanding for the year. Diluted
earnings (loss) per share is calculated based on the weighted average number of common shares
outstanding for the year, plus the dilutive effect of common stock purchase warrants, stock options
and restricted stock units using the treasury stock method. Contingently issuable shares will be
included in the calculation of basic earnings per share when all contingencies surrounding the
issuance of the shares are met and the shares are issued or issuable. Contingently issuable shares
will be included in the calculation of dilutive earnings per share as of the beginning of the
reporting period if, at the end of the reporting period, all contingencies surrounding the issuance
of the shares are satisfied or would be satisfied if the end of the reporting period were the end
of the contingency period. Due to the net losses for the years ended April 30, 2010 and 2009, basic
and diluted loss per share were the same, as the effect of potentially dilutive securities would
have been anti-dilutive.
The table below reflects the potential weighted average incremental shares of common stock
have that have been excluded from the computation of diluted loss per common share since their
effect would be anti-dilutive.
Year Ended April 30, | ||||||||
2010 | 2009 | |||||||
Stock options |
513,615 | 371,605 | ||||||
Warrants |
452,583 | 473,237 | ||||||
Restricted stock |
842 | | ||||||
Total common stock equivalents |
967,040 | 844,842 | ||||||
F-10
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
Stock-Based Payments
The Company typically recognizes expense for share-based payments based on the fair value of
awards on the date of grant. The Company uses 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. These
assumptions are based on historical information and management judgment. The Company expenses
share-based payments over the period that the awards are expected to vest, net of estimated
forfeitures. If the actual forfeitures differ from managements estimates, compensation expense is
adjusted. 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, if they should arise.
Income Taxes
Deferred income taxes have been provided to show the effect of temporary differences between
the recognition of expenses for financial and income tax reporting purposes and between the tax
basis of assets and liabilities, and their reported amounts in the consolidated financial
statements. In assessing the realizability of deferred tax assets, we assesses the likelihood that
deferred tax assets will be recovered from future taxable income, and to the extent that recovery
is not likely or there is insufficient operating history, a valuation allowance is established. We
adjust the valuation allowance in the period management determines it is more likely than not that
net deferred tax assets will or will not be realized. As of April 30, 2010 and 2009, we have
provided a valuation allowance for all net deferred tax assets due to their current realization
being considered remote.
Tax positions are positions taken in a previously filed tax return or positions expected to be
taken in a future tax return that are reflected in measuring current or deferred income tax assets
and liabilities reported in the consolidated financial statements. Tax positions include, but are
not limited to, the following:
| An allocation or shift of income between taxing jurisdictions; |
| The characterization of income or a decision to exclude reportable taxable income in a
tax return; or |
| A decision to classify a transaction, entity or other position in a tax return as tax
exempt. |
We reflect tax benefits only if it is more likely than not that we will be able to sustain the
tax position, based on its technical merits. If a tax benefit meets this criterion, it is measured
and recognized based on the largest amount of benefit that is cumulatively greater than 50% likely
to be realized. The Company has no unrecognized tax benefits as of April 30, 2010 and 2009.
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, 2010 and 2009, and has not recognized interest and/or penalties in the
statement of operations for either period.
Recent Accounting Pronouncements
In June 2009, the FASB approved the FASB Accounting Standards Codification (Codification)
as the single authoritative source for GAAP. The Codification, which was launched on July 1, 2009,
does not change current U.S. GAAP, but is intended to simplify user access by providing all
authoritative U.S. GAAP in one location. All existing accounting standards have been superseded and
all other accounting literature not included in the Codification is considered non-authoritative.
The Codification is effective for interim and annual periods ending after September 15, 2009. The
Codification did not change GAAP and did not have a material impact on the Companys consolidated
financial statements.
F-11
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
In April 2010, the Financial Accounting Standards Board (FASB) issued Accounting Standards
Update (ASU) No. 2010-13, Effect of Denominating the Exercise Price of a Share-Based Payment
Award in the Currency of the Market in Which the Underlying Equity Security Trades (ASU
2010-13). ASU 2010-13 addresses the classification of a share-based payment award with an exercise
price denominated in the currency of a market in which the underlying equity security trades. FASB
Accounting Standards Codification (ASC) Topic 718 was amended to clarify that a share-based
payment award with an exercise price denominated in the currency of a market in which a substantial
portion of the entitys equity securities trade shall not be considered to contain a market,
performance or service condition. Therefore, such an award is not to be classified as a liability
if it otherwise qualifies for equity classification. The amendments in ASU 2010-13 are effective
for fiscal years, and interim periods within those fiscal years, beginning on or after December 15,
2010, with early application permitted. We do not anticipate that the adoption of this guidance
will have a material impact on our financial position and results of operations.
In February 2010, the FASB issued ASU No. 2010-09, Amendments to Certain Recognition and
Disclosure Requirements (ASU 2010-09), which amends ASC Topic 855, Subsequent Events. The
amendments to ASC Topic 855 do not change existing requirements to evaluate subsequent events, but:
(i) defines an SEC Filer (ii) removes the definition of a Public Entity and (iii) for SEC
Filers, reverses the requirement to disclose the date through which subsequent events have been
evaluated. ASU 2010-09 was effective for us upon issuance. The adoption of this guidance did not
have a material impact on our financial position or results of operations.
In January 2010, the FASB issued ASU No. 2010-06, Improving Disclosures about Fair Value
Measurements (ASU 2010-06). ASU 2010-06 requires new disclosures for (i) transfers of assets and
liabilities in and out of levels one and two fair value measurements, including a description of
the reasons for such transfers and (ii) additional information in the reconciliation for fair value
measurements using significant unobservable inputs (level three). This guidance also clarifies
existing disclosure requirements including (i) the level of disaggregation used when providing fair
value measurement disclosures for each class of assets and liabilities and (ii) the requirement to
provide disclosures about the valuation techniques and inputs used to measure fair value for both
recurring and nonrecurring fair value measurements for level two and three assets and liabilities.
ASU 2010-06 is effective for interim and annual reporting periods beginning after December 15,
2009, except for the disclosures about activity in the roll forward for level three fair value
measurements, which is effective for fiscal years beginning after December 15, 2010. We do not
anticipate that the adoption of this guidance will have a material impact on our financial position
and results of operations.
In June 2009, the FASB issued guidance for determining the primary beneficiary of a variable
interest entity (VIE). In December 2009, the FASB issued ASU 2009-17, Improvements to Financial
Reporting by Enterprises Involved with Variable Interest Entities (ASU 2009-17). ASU 2009-17
provides amendments to ASC 810 to reflect the revised guidance. The amendments in ASU 2009-17
replace the quantitative-based risks and rewards calculation for determining which reporting
entity, if any, has a controlling financial interest in a VIE with an approach focused on
identifying which reporting entity has the power to direct the activities of a VIE that most
significantly impact the entitys economic performance and (i) the obligation to absorb losses of
the entity or (ii) the right to receive benefits from the entity. The amendments in ASU 2009-17
also require additional disclosures about a reporting entitys involvement with VIEs. ASU 2009-17
is effective for annual reporting periods beginning after November 15, 2009. We do not anticipate
that the adoption of this guidance will have a material impact on our financial position and
results of operations.
Note 3. Commitments and Contingencies
Operating leases
The Company leases office and laboratory space under a non-cancelable operating lease in
Baltimore, Maryland, which expires in April 2011, and offices, under a non-cancelable operating
lease in Tempe, Arizona which expires in May 2011.
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 fiscal year ended April 30, 2011 is
$4,750. During the fourth quarter of fiscal 2010, we commenced the process of closing our Tempe,
Arizona corporate office and consolidating our corporate administrative functions into our
headquarters in Baltimore, Maryland. In April, 2010, we executed a sublease for the Tempe office
space with an independent third party for $3,050 per month for the remaining term of the lease.
F-12
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
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.
Future minimum lease payments and receipts under non-cancelable operating leases due each year
are as follows at April 30, 2010:
Lease | Sublease | |||||||||||
Payments | Receipts | Net | ||||||||||
2011 |
$ | 109,000 | $ | (37,000 | ) | $ | 72,000 | |||||
2012 |
5,000 | | 5,000 | |||||||||
Total |
$ | 114,000 | $ | (37,000 | ) | $ | 77,000 | |||||
Rent expense under these leases was approximately $115,000 and $89,000 for the years ended
April 30, 2010 and 2009, respectively.
Research and Development Materials Purchase Agreement
In February, 2010, we entered into a research and development materials purchase agreement
with a foreign hospital for the acquisition of Tumorgrafts. Under the agreement we will pay the
foreign hospital $33,000 monthly for eighteen months, commencing March 1, 2010. Future payments
due under the agreement are as follows:
2011 |
$ | 396,000 | ||
2012 |
132,000 | |||
Total payments |
$ | 528,000 | ||
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 Asset
The Companys BPU sulfur analogs patent applications were acquired in 2007. Through April 30,
2009, the Company 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 expectation of near term commercialization. As the
Company was unable to determine the timing or amount of net cash in-flows to be generated from 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 of $284,000 equal to the
total value of the unamortized BPU patent in fiscal 2009.
Note 5. Licensing Agreements
Bithionol License Agreement
In November 2009, the Company entered into a license agreement with two United States based
companies for world-wide rights to develop and commercialize
Bithionol, a drug compound, for the
treatment of various forms of cancer including melanoma, prostate, breast and lung cancer. The
Company may terminate the license agreement in whole or in part on a country-by-country basis for
any reason upon sixty days prior written notice.
Under the terms of the agreement, the Company made an initial payment of $50,000 upon
execution of the agreement and is obligated to make a second payment of $50,000 within nine months
of executing the agreement. In addition, the Company will be required to pay $6,250,000 upon
successful completion of certain clinical milestones. The Company will also make royalty payments
based on a percentage of net sales as defined in the license
agreement. In addition, the Company will pay annual license fee payments ranging from $25,000
to $100,000 until the minimum royalty payments outlined in the license agreement are met. The
Company also agreed to pay for past patent expenses of $29,780 incurred by the two United States
based companies upon signing of the agreement. The initial payment of past patent expenses,
initial payment due upon signing the agreement and second payment due within nine months of signing
the agreement totaling $129,780 were all charged to research and development expense during the year ended April 30,
2010. No amounts have been accrued with respect to the annual licensing fees as we have determined
that it is currently not probable that any such payments will be made in future periods.
F-13
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
TAR-1 License Agreement
In October 2009, the Company entered into a license agreement with an Israeli company for
world-wide rights to develop and commercialize a transactivation and apoptosis restoring (TAR-1)
developmental drug compound. The Company may terminate the license agreement in whole or in part
on a country-by-country basis for any reason upon sixty days prior written notice.
Under the terms of the agreement, the Company made an initial payment of $60,000. In addition,
the Company will be required to pay $6,140,000 upon successful completion of certain clinical
milestones, $5,000,000 upon reaching certain regulatory approvals and $23,000,000 upon the
achievement of certain commercial milestones. The Company will also make royalty payments based on
net sales as defined in the license agreement. In addition, the Company will pay an annual
licensing fee of $30,000 for the first three years of the agreement beginning on the second year of
the agreement. The Company also agreed to pay for $118,000 of past patent expenses incurred by the
Israeli company prior to the execution of the agreement. The payment of past patent expenses,
first annual licensing fee and initial payment totaling $208,000 were all charged to research and development expense
during the year ended April 30, 2010.
Benzoylyphenylerea License Agreement
In July 2009, the Company entered into a joint development and licensing agreement with a
third party for the development of a soluble form of SG410, the Companys BPU sulfur analog
compound. Under the joint agreement, the third party will be entitled to milestone payments of
$2,000,000 upon the success of certain regulatory approvals and royalty payments on net sales of
the licensed BPU product. No amounts were due under this agreement as of April 30, 2010.
Liposome Option Agreement
In February 2010, the Company entered into an exclusive option agreement with a Canadian
company. The option agreement grants the Company the exclusive right to review Liposome, a drug
compound, for the treatment of various forms of cancer which include melanoma, prostate, breast
and lung cancer, for the period of one year beginning in February 2010.
Under the terms of the agreement, the Company made a payment of $40,000 upon execution of the
agreement. In addition, the Company agreed to reimburse the Canadian company up to $10,000 for
patent costs incurred over the one year option period. All amounts paid were recorded as research
and development expense during the year ended April 30, 2010.
Note 6. Stock-Based Payments
2008 Equity Incentive 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-employees under a 2008 Equity Incentive Plan
which 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-14
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
For stock-based payments to non-employee consultants, the fair value of the share-based
consideration issued is used to measure the transaction, as management believes this to be a more
reliable measure of fair value than the services received. The fair value of the award is measured
at the price of the Companys common stock or stock options on the date that the commitment for
performance by the non-employee consultant has been reached or performance is complete.
Director Compensation Plan
On February 22, 2010, the Compensation Committee of the Board of Directors of the Company
adopted the Director Compensation Plan of 2010 (the Director Plan) to replace the Companys
former compensation policy for directors, effective for the 2010 calendar year commencing January
1, 2010. Under the Director Plan, independent directors of the Company are entitled to an annual
award of five-year options to purchase 50,000 shares of the Companys unregistered common stock,
and the Chairman of the Board of the Company is entitled to an annual award of options to purchase
100,000 shares of the Companys unregistered common stock. Independent directors who serve on one
or more Board committees will also receive an annual grant of five-year options to purchase 50,000
shares of the Companys unregistered common stock or 50,000 shares of restricted unregistered
common stock. For the initial Director Plan year, an independent director can chose to receive a
cash fee equal to the value of the unregistered restricted common stock that would have otherwise
been granted. The Chairman of the Board is also entitled to the same arrangement for his services
on Board committees at a rate of twice that of an independent director. The Company will also pay
each independent director $15,000 to offset the tax liability in respect of any unregistered
restricted stock awards. All unregistered common stock options and unregistered restricted stock
issued under the Director Plan vest quarterly at a rate of 25%.
The Companys Board has not approved a limit to the number of shares available for issuance
under the 2008 Equity Incentive plan or the Director Compensation Plan, and as such the Board approves
each grant individually.
Stock-based compensation in the amount of $593,000 and $464,000 was recognized for the years
ended April 30, 2010 and 2009, respectively. Stock-based compensation costs were recorded as
follows:
Years Ended April 30, | ||||||||
2010 | 2009 | |||||||
Cost of Personalized oncology services |
$ | | $ | 4,000 | ||||
Research and development |
124,000 | 127,000 | ||||||
General and administrative |
469,000 | 333,000 | ||||||
Total stock-based compensation expense |
$ | 593,000 | $ | 464,000 | ||||
Black-Scholes assumptions used to calculate the fair value of options and warrants granted
during the years ended April 30, 2010 and 2009 were as follows:
Years Ended April 30, | ||||||||
2010 | 2009 | |||||||
Expected term in years |
2.6 6.0 | 1.5 6.0 | ||||||
Risk free interest rates |
1.2% 3.1% | 1.9% 3.4% | ||||||
Volatility |
94% 123% | 69% 94% | ||||||
Dividend yield |
0% | 0% |
The Black-Scholes option valuation model was developed for use in estimating the fair value of
short-traded options that have no vesting restrictions and are fully transferable. In addition,
option valuation models require the input of assumptions including expected stock price volatility.
The risk-free interest rate is based on the United States treasury security rate with a term
consistent with the expected term of the award at the time of the grant. The expected holding
period of options are based on the Companys historical experience. The volatility rates are based
upon a weighted average of a five member peer group of companies in our industry. The Company does
not anticipate paying a dividend, and therefore no expected dividend yield was used.
F-15
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
The weighted average fair value of stock options granted during the fiscal years ending April
30, 2010 and 2009, was $0.61 and $0.90, respectively.
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 | ||||||||||||||||||
Non- | and | Contractual | Intrinsic | |||||||||||||||||
Employees | Employees | Total | Life (Years) | Value | ||||||||||||||||
Outstanding as of May 1, 2008 |
1,815,000 | 140,000 | 1,955,000 | |||||||||||||||||
Granted |
20,000 | 398,000 | 418,000 | |||||||||||||||||
Change in employee status |
(500,000 | ) | 500,000 | | ||||||||||||||||
Exercised |
(25,000 | ) | | (25,000 | ) | |||||||||||||||
Outstanding as of April 30, 2009 |
1,310,000 | 1,038,000 | 2,348,000 | 4.83 | $ | 594,000 | ||||||||||||||
Granted |
80,000 | 974,948 | 1,054,948 | |||||||||||||||||
Change in employee status |
575,000 | (575,000 | ) | | ||||||||||||||||
Forfeited |
(75,000 | ) | (10,000 | ) | (85,000 | ) | ||||||||||||||
Outstanding as of April 30, 2010 |
1,890,000 | 1,427,948 | 3,317,948 | 4.37 | $ | 250,000 | ||||||||||||||
Vested and expected to vest as
of April 30, 2010 |
1,890,000 | 1,427,948 | 3,317,948 | 4.37 | $ | 250,000 | ||||||||||||||
Exercisable as of April 30, 2010 |
1,511,667 | 351,000 | 1,862,667 | 3.06 | $ | 317,000 | ||||||||||||||
Additional information regarding options outstanding as of April 30, 2010 is as follows:
Options Outstanding | Options Exercisable | |||||||||||||||||||
Range of | Weighted | Weighted | ||||||||||||||||||
Exercise | Number | Weighted Average | Average | Number | Average | |||||||||||||||
Prices | Outstanding | Contractual Life (Yrs) | Exercise Price | Exercisable | Exercise Price | |||||||||||||||
$0.17 $0.30 | 815,000 | 1.96 | $ | 0.25 | 648,334 | $ | 0.24 | |||||||||||||
$0.75 $0.87 | 1,194,948 | 4.05 | 0.77 | 695,000 | 0.76 | |||||||||||||||
$1.00 $1.18 | 1,308,000 | 6.17 | 1.11 | 519,333 | 1.13 | |||||||||||||||
$0.17 $1.18 | 3,317,948 | 4.37 | $ | 0.77 | 1,862,667 | $ | 0.68 | |||||||||||||
On May 15, 2007 the Company granted a consultant 500,000 stock options at $0.30 per share, as
incentive to 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 with the Company. This change in employment status was recognized
prospectively such that the fair value of the award is re-measured at each subsequent reporting
period until the award is fully vested. As a result of the modification, charges to expense for the
fiscal years ended April 30, 2010 and 2009 were $60,900 and $126,900, respectively.
F-16
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 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 Principal
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 expense under the
award ratably over the remaining vesting period. As the result of the modification of the option
grant, the Company recorded $124,000 in stock compensation expense for the year ended April 30,
2009. Effective January 1, 2010, this individual resigned as President and Principal Executive
Officer of the Company, and became a consultant to the Company. In conjunction with this
individuals departure, the Company amended this individuals employment agreement to accelerate
the vesting of 166,670 unvested stock options to December 31, 2009. The Company has considered this
a Type III modification which resulted in the recording of an additional $43,000 charge to
compensation expense during fiscal 2010. Total stock compensation
expense recognized related to this option grant for the fiscal year ended April 30, 2010 was
$104,700.
Restricted Stock Grants
In August, 2009, the Company granted 8,526 shares of our common stock with a fair value of
$0.77 per share, to our Chief Financial Officer. The restricted shares vest at the on the
anniversary of the grant date evenly over three years from the date of grant.
In February, 2010, the Company granted 50,000 shares of our common stock with a fair value of
$0.80 per share to a board member in accordance with the Director Compensation Plan. Of the grant,
12,500 shares vested immediately with the remaining 37,500 shares vesting at the end of each
calendar quarter through September 2010.
A summary of the activity related to restricted stock granted under the 2008 Equity Incentive
and Director Compensation Plan is as follows:
Weighted Average Grant | ||||||||
Total Shares | Date Fair Value Per Share | |||||||
Nonvested as
of May 1, 2009 |
| $ | | |||||
Granted |
58,526 | 0.80 | ||||||
Vested |
25,000 | 0.80 | ||||||
Forfeited, canceled, or expired |
| | ||||||
Nonvested as of April 30, 2010 |
33,526 | $ | 0.80 | |||||
Total shares vested as of April 30, 2010 |
25,000 | $ | 0.80 | |||||
The total fair value of shares vested during fiscal 2010 and 2009 was $22,000 and $0,
respectively.
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.
During the years ended April 30, 2010 and 2009, warrants for 15,408 and 216,121 shares of our
common stock, respectively, were exercised for total cash proceeds of approximately $3,000 and
$50,000, respectively.
F-17
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
Warrants outstanding for the purchase of our common stock are as follows:
April 30, | ||||||||||
Exercise price | Expiration date | 2010 | 2009 | |||||||
$0.15 |
October 2011 | 307,400 | 315,104 | |||||||
$0.25 |
October 2011 | 291,583 | 299,287 | |||||||
$1.00 |
July 2014 | 150,000 | 150,000 | |||||||
748,983 | 764,391 | |||||||||
Weighted average exercise price | $ | 0.36 | $ | 0.36 | ||||||
As of April 30, 2010 and 2009, there were exercisable outstanding warrants of 748,983 and
614,391, respectively.
Note 7. 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, 2010 and 2009.
Common Stock
In September 2009, the Company issued 250,000 shares of the Companys unregistered common
stock valued at $175,000 to the original owners of the SG 410 patent whereby the Company had
previously acquired the rights to the SG 410 patent in February 2007. The unregistered common
stock was issued as the final contingent payment due upon issuance of the patent which occurred in
September 2009. The $175,000 expense is included in research and development expense in the
accompanying consolidated statement of operations.
From December 2009 through April, 2010, the Company received gross proceeds of $2,250,000 from
the private placement of 3,000,000 shares of the Companys unregistered common stock. This
unregistered common stock was sold to accredited investors exempt from registration as provided by
Section 4(2) of the Securities Act of 1933 and Regulation D. The Company incurred approximately
$28,000 in direct and incremental costs related to the offering.
As of April 30, 2010, the Company had executed subscription agreements for the private
placement of unregistered common stock totaling $750,000.
Note 8. Provision for Income Taxes
For the years ended April 30, 2010 and 2009 the Company recorded no net provision for income
taxes in either year. The components of the provision are as follows:
Federal | State | Total | ||||||||||
2010 |
||||||||||||
Current |
$ | | $ | | $ | | ||||||
Deferred |
(922,000 | ) | (198,000 | ) | (1,120,000 | ) | ||||||
Change in valuation allowance |
922,000 | 198,000 | 1,120,000 | |||||||||
Total Current |
| | | |||||||||
2009 |
||||||||||||
Current |
| | | |||||||||
Deferred |
(313,000 | ) | (68,000 | ) | (381,000 | ) | ||||||
Change in valuation allowance |
313,000 | 68,000 | 381,000 | |||||||||
Total Current |
$ | | $ | | $ | |||||||
F-18
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
A reconciliation between the Companys effective tax rate and the United States statutory tax
rate for the years ended April 30, 2010 and 2009 is as follows:
Year Ended April 30, | ||||||||
2010 | 2009 | |||||||
Federal income tax at statutory rate |
35.0 | % | 35.0 | % | ||||
State income tax, net of federal benefit |
4.4 | 4.5 | ||||||
Permanent difference |
(0.2 | ) | (0.3 | ) | ||||
Other True-ups |
(0.9 | ) | (0.0 | ) | ||||
Change in valuation allowance |
(38.3 | ) | (39.2 | ) | ||||
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, 2010 and 2009 consist of the following:
April 30, | ||||||||
2010 | 2009 | |||||||
Accrued liabilities |
$ | 25,000 | $ | 7,000 | ||||
Depreciation and amortization |
(1,000 | ) | (10,000 | ) | ||||
State taxes |
(141,000 | ) | (72,000 | ) | ||||
Stock-based compensation expense |
687,000 | 450,000 | ||||||
Capitalized R&D expenditures |
1,436,000 | | ||||||
Charitable contribution carry-forward |
| 41,000 | ||||||
Foreign net operating loss carry-forward |
130,000 | | ||||||
Net operating loss carry-forward |
139,000 | 739,000 | ||||||
Total deferred tax assets |
2,275,000 | 1,155,000 | ||||||
Less: valuation allowance |
(2,275,000 | ) | (1,155,000 | ) | ||||
Net deferred tax asset |
$ | | $ | | ||||
Management has evaluated the available evidence about future taxable
income and other possible sources of realization of deferred tax assets and has established
a valuation allowance of $2,275,000 at April, 30, 2010. The Company has established a valuation allowance against
its deferred tax assets as it is currently more-likely-than-not that all or a portion of a deferred
tax asset will not be realized. The valuation allowance reduces deferred tax assets to an amount that management believes will more likely than not be realized.
Changes in valuation allowances from period to period are included in the tax provision in the period of change. In determining whether a
valuation allowance is required, we take into account all evidence with regard to the utilization of a deferred tax asset including
past earnings history, expected future earnings, the character and jurisdiction of such earnings, unsettled circumstances that, if unfavorably resolved,
would adversely affect utilization of a deferred tax asset, carryback and carryforward periods, and tax strategies that could potentially enhance the likelihood of realization of a deferred tax asset.
At April 30, 2010 and 2009, the Companys estimated net operating loss carry-forwards were
approximately $330,000 and $1,759,000. At April 30, 2010, the Companys foreign net operating loss
carry-forward was approximately $309,000. The Companys federal and state net operating losses
begin expiring in 2030.
The Company is in the process of evaluating its acquired net operating losses and the impact
of applicable Section 382 analysis limitations on those net operating losses. The reason the Companys
net operating loss carryforwards decreased from fiscal 2009 to 2010 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 losses, there was no
impact on net loss.
The Company files income tax returns in various jurisdictions with varying statues of
limitations. As of April 30, 2010, the earliest tax year still subject to examination for state purposes is fiscal 2007.
The Companys tax years for periods ending April 30, 1994 and forward are
subject to examination by the United States and certain states due to the carry-forward of
unutilized net operating losses.
F-19
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
Note 9. Related Party Transactions
Related party transactions include transactions between the Company and certain of its
shareholders, 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 fiscal years ended April 30, 2010 and 2009, we paid one of our directors and former
Chief Executive Officer, $103,593, and $185,000, respectively, in consulting fees and salary.
Additionally, during the fiscal year ended April 30, 2009 we paid approximately $361,000 for
accrued salaries payable to this individual as of April 30, 2008. No amounts were
outstanding to this individual as of April 30, 2010 or 2009.
During the years ended April 30, 2010 and, 2009, the Company paid certain members of our Board
of Directors $35,000 and $105,000, respectively, for consulting services unrelated to their duties
as board members.
We incurred $180,000 in expense for the years ended April 30, 2010 and 2009, respectively from
a substantial stockholder of the Company for consulting fees. No amounts were payable to this
stockholder as of April 30, 2010 and 2009.
During the year ended April 30, 2010 and 2009, we recognized approximately $60,000 and
$259,000, respectively, in revenues from companies whose board members were also members of our
Board of Directors. Of these amounts, $40,000 was outstanding as a receivable at April 30, 2010.
Stock Re-purchase Agreement
In May 2009, the Board of Directors approved a stock repurchase agreement with a Board member
that obligates the Company to purchase up to approximately $407,000 of the Companys common stock
held by the Board member over the next two years providing that the Board member continues his
services under a consulting agreement executed concurrently with the stock repurchase agreement.
Under the stock repurchase agreement, the Company made an initial purchase of $125,000 of Companys
shares of common stock, and may be required to make quarterly purchases of $31,250 of the Companys
common stock held by the Board member after the end of each fiscal quarter. Such purchases may
occur quarterly through April 2011 provided the consulting agreement remains in effect. The
purchase price per share of the common stock for each purchase is equal to the lesser price of
$0.50 or 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.
Under the agreement, the Company has paid this Board member approximately $218,000 for the
purchase of 474,289 shares of our common stock as of April 30, 2010.
The Company accounted for its obligation to repurchase shares of its common stock under the
stock repurchase agreement as a put option entered into in connection with a compensation
arrangement, and valued the obligation at fair value. The fair value of the put option continues
to be de minimus, as the purchase price of the shares of common stock as calculated under the
agreement was less than the fair value of the Companys common stock. Because the requirement for
the Company to transfer cash in exchange for the shares of common stock is not within its control,
the Company has recorded an amount equal to the total purchase price required under the arrangement
in temporary equity with a corresponding reduction of additional paid-in capital. As of April 30,
2010,
the Company has approximately $188,000 remaining to be paid under the stock repurchase
agreement based on the stock price as of that date.
F-20
Table of Contents
CHAMPIONS BIOTECHNOLOGY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
APRIL 30, 2010 AND 2009
Further, under the stock repurchase agreement, the Company, at its option, may purchase all or
any part of the shares that have not been previously purchased, up to but not to exceed, 2,250,000
shares of the common stock at the discretion of the Company, subject to the pricing formula
described above. This option may be exercised during the period of the consulting agreement or for
a period up to one year following the termination of the consulting agreement. The Company has
accounted for this as a purchased call option on its own stock. As this arrangement is indexed to,
and will be settle in, the Companys own shares of common stock, it has recorded a decrease to
stockholders equity at the call options fair value of $1,774,000. Additionally, because the
option provides the Company the ability to repurchase its own shares of common stock at a price
less than fair value and the call option was provided by a significant shareholder, the Company has
recorded a corresponding contribution to stockholders equity of $1,774,000.
Subsequent to April 30, 2010, the Company repurchased an additional 77,962 shares of our
common stock for $31,250 per the terms of the repurchase agreement noted above.
Note 10. Exit Costs
During the fourth quarter of fiscal 2010, the Company commenced the process of closing its
Tempe, Arizona corporate office and consolidating the Companys corporate administrative functions
into its headquarters in Baltimore, Maryland. In April, 2010, the Company executed a sublease for
the Tempe office space with an independent third party for the remaining term of the lease and
accrued a charge of approximately $36,000 for costs of moving the corporate office to Baltimore.
This charge is net of monthly sublease income of approximately $3,000. The Company also recorded a
loss of approximately $22,000 relative to certain equipment that was disposed of as part of this
relocation. All exit costs have been included in general and administrative expenses in the
accompanying consolidated statement of operations. The following table is a summary of our exit
costs by category and amounts paid and accrued through April 30, 2010.
Estimated | Payments/ | Amount | ||||||||||
Expense | Losses to Date | Remaining | ||||||||||
Severance payments |
$ | 11,000 | $ | 5,000 | $ | 6,000 | ||||||
Future lease payments, net of sublease rental |
18,000 | 1,000 | 17,000 | |||||||||
Moving costs and other |
7,000 | 5,000 | 2,000 | |||||||||
Disposal of assets |
22,000 | 22,000 | | |||||||||
Total |
$ | 58,000 | $ | 33,000 | $ | 25,000 | ||||||
F-21