IOVANCE BIOTHERAPEUTICS, INC. - Annual Report: 2009 (Form 10-K)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One):
x
|
ANNUAL REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
For
the fiscal year ended December 31, 2009
OR
o
|
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
For
the transition period from __________ to __________
Commission
File Number 000-53127
GENESIS
BIOPHARMA, INC.
(Exact
name of registrant as specified in its charter)
Nevada
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75-3254381
|
|
(State
or other jurisdiction
of
incorporation or organization)
|
(I.R.S.
Employer
Identification
No.)
|
1601
N. Sepulveda Blvd., #632, Manhattan Beach, CA
|
90266
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant’s
telephone number, including area code: (866) 963-2220
Securities
registered pursuant to Section 12(b) of the Act: None
Securities
registered pursuant to Section 12(g) of the Act: Common Stock, $0.000041666
par value
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 Section 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 is not contained herein, and will not be contained, to the
best of the registrant’s knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or
any amendment to this Form 10-K. þ
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
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 registrant is a shell company (as defined in
Rule 12b-2 of the Act). Yes o No þ
State the
aggregate market value of the voting and non-voting common equity held by
non-affiliates computed by reference to the price at which the common equity was
last sold, or the average bid and asked price of such common equity, as of the
last business day of the registrant’s most recently completed second fiscal
quarter. The aggregate market value of the common stock held by non-affiliates
as of June 30, 2009 was $53,000.
Indicate
the number of shares outstanding of each of the registrant’s classes of common
stock, as of the latest practicable date. As of March 29, 2010, there were
71,860,008 shares of the registrant’s common stock outstanding.
Table of
Contents
PART
I
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2
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Item
1.
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Business |
2
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Item
1A.
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Risk Factors |
6
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Item
1B.
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Unresolved Staff Comments |
6
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Item
2.
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Properties |
7
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Item
3.
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Legal Proceedings |
7
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Item
4.
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(Removed and Reserved) |
7
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PART
II
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8
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Item
5.
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Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities |
8
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Item
6.
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Selected Financial Data |
8
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Item
7.
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
8
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Item
7A.
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Quantitative and Qualitative Disclosures About Market Risk |
11
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Item
8
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Financial Statements and Supplementary Data |
12
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Item
9.
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Changes in and Disagreements With Accountants on Accounting and Financial Disclosure |
21
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Item
9A(T)
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Controls and Procedures |
21
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Item
9B.
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Other Information |
23
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PART
III
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24
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Item
10.
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Directors, Executive Officers and Corporate Governance |
24
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Item
11.
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Executive Compensation |
25
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Item
12.
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Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters |
25
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Item
13.
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Certain Relationships and Related Transactions, and Director Independence |
26
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Item
14.
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Principal Accounting Fees and Services |
27
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PART
IV
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28
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Item
15.
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Exhibits, Financial Statement Schedules |
28
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i
PART
I
Item
1. Business
Overview
Genesis
Biopharma, Inc. (formerly named Freight Management Corp.) (“we” or the
“Company”) was incorporated in the State of Nevada on September 17, 2007 to
engage in the development of an internet-based, intelligent online system for
business owners, freight forwarders, and business people in the shipping/freight
industry and export/import industry who require assistance with their freight
and shipping related inquiries. On March 15, 2010, the Company and Genesis
Biopharma, Inc., a Nevada corporation and a newly formed merger subsidiary
wholly owned by the Company (“Merger Sub”), consummated a merger transaction
(the “Merger”) whereby Merger Sub merged into the Company, with the Company as
the surviving corporation. The Company and Merger Sub filed Articles of Merger
on March 15, 2010 with the Secretary of State of Nevada, along with the
Agreement and Plan of Merger entered into by the two parties effective as of
March 15, 2010 (the “Merger Agreement”). The Merger Agreement and the Articles
of Merger provided for an amendment of the Company’s Articles of Incorporation,
which changed the Company’s name to “Genesis Biopharma, Inc.” effective as of
March 15, 2010.
As a
result of the Merger, the Company acquired all of the assets and contractual
rights, and assumed all of the liabilities, of Merger Sub with respect to an
Asset Purchase Agreement (the “Purchase Agreement”) entered into effective March
15, 2010, by the Company and Merger Sub with Hamilton Atlantic, a Cayman Islands
company (“Hamilton”), whereby Hamilton sold, and Merger Sub acquired, all of
Hamilton’s rights, title and interest to certain assets related to the
development and commercialization of biotechnology drugs, primarily anti-CD55
antibodies (the “Anti-CD55 Antibody Program”), including certain patents, patent
applications, materials, and know-how. The Anti-CD55 Antibody Program consists
of antibodies that could be developed and commercialized for the treatment of
cancer. As consideration, the Company agreed to issue to Hamilton 20,960,016
shares of the Company’s common stock.
On March
15, 2010, after the effectiveness of the Merger, we entered into a Patent and
Know How Licence (the “License Agreement”) with Cancer Research Technology
Limited, a company registered in England and Wales (“CRT”). Pursuant to the
License Agreement, CRT granted to the Company an exclusive, worldwide right and
license in certain intellectual property related to a proprietary, therapeutic
use of anti-CD55 antibodies, including rights to patents and patent applications
related thereto, to research, develop, use, make, distribute, and sell products
utilizing the licensed intellectual property. The license granted to the Company
expires on the later to occur of the expiration of the relevant licensed patent
in the relevant country or 10 years after the date that the first therapeutic
product was placed on the market in such country. In consideration for the
license, the Company agreed to pay to CRT GBP30,000 in royalties upon the
effective date of the License Agreement. In addition, the Company agreed to pay
CRT additional royalties based on the achievement of certain milestones,
including the consummation of financing by the Company and other milestones
relating to the commencement of Phase III clinical studies, the filing of new
drug applications, and the grant of marketing approval related to the licensed
products.
As a
result of our recent acquisition of the assets related to the Anti-CD55 Antibody
Program and the License Agreement, we have become a biopharmaceutical company
engaged in the development and commercialization of drugs and other clinical
solutions for underserved diseases, including metastatic cancers and lethal
infectious diseases.
Plan
of Operation
For the
coming year we plan to continue to develop and commercialize proprietary
products that provide sustained clinical value. Such products will likely be
directed towards aggressive diseases such as metastatic cancers and lethal
infectious diseases, although other large underserved markets will be targeted
as well. The key elements of our business strategy that we plan on implementing
are as follows:
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*
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Advancing,
selectively and cost-effectively, select product candidates based on
proof-of-concept studies and ongoing assessment of their market
potential;
|
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*
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Developing
and deploying our internal know-how related to smart search methods and
drug discovery methods to develop proprietary cocktail therapies and
personalized medicine regimens. If discoveries are made within this
program, they may be commercialized either as a proprietary combination or
cocktail drug therapy, or possibly as a service that will assist
physicians in prescribing combination or cocktail drug
regimens;
|
|
*
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Establishing
strategic relationships with marketing and development partners to
maximize sales and development potential for our products and to obtain
access to additional development, commercial, or financial resources;
and
|
|
*
|
Licensing
or acquiring enabling technologies and complementary drug candidates,
preferably at the clinical stage.
|
2
VG102
Development Plans
VG102 is
a chimeric monoclonal antibody targeting the CD55 antigen that is over-expressed
on approximately 80 percent of solid tumors and has broad clinical
applicability. The parent antibody has previously been used extensively as an
immunodiagnostic agent in humans. There is an urgent need to enhance the
efficacy of the current generation of anti-cancer antibodies. VG102 has
potential for development in a wide range of cancer indications and also as
either a stand-alone monotherapy or in combination with other marketed cancer
immunotherapies. We believe VG102 has potential to be developed as a platform
technology.
The
primary strategy for the development of VG102 will be to develop the antibody as
a monotherapy in the first instance, with the expectation that we will be
required by regulatory authorities to evaluate the antibody in combination with
standard treatment (likely chemotherapy) against standard treatment alone.
Furthermore, it may be sensible to select, as the initial disease target, an
indication which would fall within the European Union and U.S. Orphan Drug
designation (diseases with relatively few patients), as qualifying for this
designation affords certain benefits to companies developing such drugs, such as
market exclusivity, funding and tax benefits. This route lowers the barriers to
market entry for the new product. The product may then be subsequently developed
for other indications, which may have larger markets. A further possibility is
the development of the product for fast-track status. These programs, typically
of the U.S. Food and Drug Administration (the “FDA”), are designed to facilitate
the development and expedite the review of new drugs that are intended to treat
serious or life-threatening conditions and that demonstrate the potential to
address unmet medical needs. To be eligible for this program, there must be no
effective treatment available for the disease or the product in question must
bring certain benefits over existing treatments.
We
believe the VG102 product may also have utility as a combination therapy, to be
evaluated in combination with other agents, which are already approved for
cancer therapy. It is generally the case that investigational agents entering
human clinical trials must initially be trialed in combination with agents that
are already approved for the target indication. These are usually
chemotherapeutic regimens, although with the approval of newer, biological
agents such as monoclonal antibodies, there may be the potential for comparison
with these agents in a clinical trial setting.
Colorectal
cancer monotherapy is a likely indication for VG102. The market for similar
targeted colorectal cancer therapies was $7 billion in 2006, based on
information obtained from BioPlan Associates. The market success of these drugs
is unusual in that they do not typically replace other drugs. They are often
added to therapy regimes, having the effect of adding to the total colorectal
cancer market. Some regimes are also increasing from two to three drugs,
creating additional market opportunity. In addition to colorectal cancer, CD55
has broad applicability in other cancers given that CD55 is over-expressed on 80
percent of solid tumors. This includes potential for treating breast and lung
cancers as well. The parent antibody of VG102 has already been used safely in
over 100 human patients in diagnostic cancer imaging studies. Based on this
data, along with computer-generated studies performed on the chimeric version,
we believe that VG102 will be safe and non-immunogenic.
Additional
Plans for Drug Discovery Activities and Clinical Applications
We will
also focus on developing and utilizing smart search algorithms for use in drug
discovery activities and other clinical applications. These algorithms, which
are based on proven engineering methods, may eventually provide clinical utility
in multiple areas, including but not limited to the discovery of cocktail
therapies, construction of personalized medicine regimens, and for improved
optimization of research or manufacturing methods. Indications of interest for
cocktail therapies include lethal pandemic influenza, Methicillin-Resistant
Staphylococcus Aureus
(an infectious bacterial disease, “MRSA”), and diseases of normal aging.
For construction of personalized medicine regimens, possible areas of clinical
utility include pharmaceutical treatment of depression, pharmaceutical treatment
of late-stage cancer, and optimized use of nutritional supplements.
We will
require additional funds to implement the development programs set forth above.
The Company anticipates spending between $500,000 to $1,000,000 in the coming
year to process the VG102 drug development program, cocktail drug discovery
activities, and potential licensing opportunities. These funds may be raised
through equity financing, debt financing, or other sources.
3
Intellectual
Property
The
unique binding specificity of the VG102 parent antibody to CD55 underpins the
strength of the intellectual property position, allowing potential protection
for use in cancer as a monotherapy or in combination therapies. It is the
subject of eight (8) patent applications in major markets, including the United
States, European Union, and Japan. Exclusive and worldwide patent rights are
licensed from CRT. In addition, we have acquired the rights to eleven (11)
patents and patent applications related primarily to the Anti-CD55 Antibody
Program through our asset purchase transaction with Hamilton.
Competition
The
development and commercialization of pharmaceutical products is highly
competitive. We will be competing against a wide range of pharmaceutical and
biotechnology companies that have greater resources than us, including existing
research and development programs in the markets we plan to target. We must
compete with these companies both in regard to the discovery technology we use
to identify potential product candidates and in regard to the development and
commercialization of our product candidates themselves.
Competition
in the pharmaceutical and medical products industries is intense and is
characterized by costly and extensive research efforts and rapid technological
progress. We are aware of many pharmaceutical companies also actively engaged in
the development of therapies for the treatment of cancer and other clinical
indications that are of interest to the Company. These companies have
substantially greater research and development capabilities as well as
substantially greater marketing, financial and human resources than we do. In
addition, many of these companies have significantly greater experience than we
have in undertaking pre-clinical testing, human clinical trials and other
regulatory approval procedures. Such companies include, among others, Roche,
Amgen, GlaxoSmithKline, and Novartis. Our competitors may develop technologies
and products that are more effective than those we are currently researching and
developing. Such developments could render our products less competitive or
possibly obsolete. We are also competing with respect to marketing capabilities
and manufacturing efficiency, areas in which we have limited experience.
Mergers, acquisitions, joint ventures and similar events may also significantly
change the competition.
There are
many available drugs for bacterial infections, cancer, and other clinical
indications of interest. All of these available drugs are or will be marketed by
pharmaceutical companies with substantially greater resources than we have. In
addition, a number of generic pharmaceutical products are available. The
availability of a large number of branded prescription products, generic
products and over-the-counter products could limit the demand for, and the price
we are able to charge for a product candidate, if approved. In addition to those
drugs discussed, there may be alternative treatments or preventive measures
available that significantly impact the market potential of our product
candidates.
Governmental
Regulations
FDA
Regulation of Drugs and Biologics
Prescription
pharmaceutical products are subject to extensive pre- and post-marketing
regulation by the FDA, including regulations that govern the testing,
manufacturing, safety, efficacy, labeling, storage, record-keeping, advertising
and promotion of the products under the Federal Food, Drug and Cosmetic Act, and
by comparable agencies in most foreign countries.
In the
United States, at the federal government level, the FDA is principally
responsible for regulating drugs and biologics, including the product candidates
we have under development. Failure to comply with applicable regulatory
requirements may subject a company to administrative or judicially imposed
sanctions, such as warning letters, product recalls, product seizure,
injunctions, civil penalties, disgorgement of past or future profits, criminal
prosecution, suspension of production, license suspension or revocation,
withdrawal of an approval, or FDA refusal to approve pending marketing
applications.
The steps
ordinarily required before a new pharmaceutical product may be marketed in the
United States begin primarily with preclinical testing. Preclinical tests
include laboratory evaluation of product chemistry, toxicology and other
characteristics. Animal studies are used to assess the potential safety of the
product. Many preclinical studies are regulated by the FDA and must comply with
good laboratory practice, or GLP, regulations. Violations of these regulations
can, in some cases, lead to invalidation of the studies, requiring such studies
to be replicated if the data are to be submitted to the FDA in support of a
marketing application for a new drug.
4
With
regard to cocktail therapies or combination drugs, in March 2006, the FDA
released Guidance for Industry: Nonclinical Safety Evaluation of Drug
Combinations. The guidance discusses what preclinical studies are appropriate to
support the clinical study and approval of new combination products and
therapies. In the case of new products composed of previously marketed drugs,
the guidance states that generally the FDA believes sufficient clinical and
preclinical data will exist for each drug component separately. Therefore, in
such a case, the issues to be resolved before the new product is tested in
humans generally relate to possible interactions between the components of the
proposed product. The guidance identifies specific potential interaction issues
to be considered and suggests the type of testing that may be appropriate to
resolve any issues that require such testing.
The
results of the preclinical development work, together with other information as
required by the FDA, are summarized in an investigational new drug application,
or “IND”, which must be submitted to the FDA before the drug may be provided to
clinical investigators for use in humans in clinical trials. An IND also sets
forth the plan for investigating the drug, including the protocols for each
planned study. FDA regulations provide that human clinical trials may begin 30
days following submission of an IND, unless the FDA advises otherwise or
requests additional information, clarification, or additional time to review the
application. Clinical trials cannot begin until any concerns raised by the FDA
have been resolved.
Each
clinical trial must also be approved by an independent institutional review
board, or “IRB”, which is typically associated with the institution or research
facility at which the investigator will conduct the trial, before the trial may
begin. The IRB must approve the protocol and the procedures for obtaining the
informed consent of the study participants. An IRB will consider, among other
things, ethical factors, the safety of human subjects, and the possible
liability of the institution in which the study will be conducted. The IRB is
required to conduct continuous review of the trials at intervals appropriate to
the degree of risk involved and may suspend or terminate its approval if the
trials are not being conducted in accordance with the IRB’s approval or there
has been unexpected serious harm to subjects.
While
conducting a clinical trial, a company is required to monitor the investigators’
compliance with the clinical study protocol and other FDA requirements,
including the requirements to submit reports to the clinical trial sponsor, the
IRB, and the FDA, and to keep detailed records regarding study findings and use
and disposition of the study drug. Although monitoring can help reduce the risk
of inadequate compliance by study investigators, it cannot eliminate this risk
entirely. Inadvertent regulatory noncompliance by the investigator, or
intentional investigator misconduct, can jeopardize the usefulness of study
results and, in rare circumstances, require a company to repeat a study. A
company must report to the FDA any adverse event that is both unexpected and
serious and there is a reasonable possibility that the event may have been
caused by the investigational drug. In addition, a company must, within seven
days of the occurrence of any unexpected fatal or life-threatening event that
may have been caused by the drug, report such event to the FDA. The FDA may stop
the trials by placing a “clinical hold” on such trials because of concerns
about, for example, the safety of the product being tested. Such holds can cause
substantial delay and in some cases may require abandonment of a product
candidate.
Clinical
testing in humans involves the administration of the investigational drug to
healthy volunteers or to patients under the supervision of a qualified principal
investigator, usually a physician, pursuant to an FDA-reviewed protocol. Human
clinical trials typically are conducted in three sequential phases, but the
phases may overlap. Phase 1 clinical trials consist of testing the product in a
small number of patients or healthy volunteers, primarily to evaluate the drug’s
safety, at one or more dosage levels, as well as to study the drug’s
pharmacokinetic and/or pharmacodynamic profile. In Phase 2 clinical trials, in
addition to safety, the efficacy of multiple dose levels of the product is
evaluated in a patient population. Phase 3 clinical trials typically involve
additional testing for safety and clinical efficacy in an expanded population at
multiple geographically dispersed sites.
Upon
completion of clinical trials, a company seeking FDA approval to market a new
drug must file a new drug application, or “NDA”, with the FDA, or in the case of
a biological product, a biological license application, or “BLA”. To approve an
NDA, the FDA must determine, based on the information submitted in the
application, that the drug is safe and effective for its intended uses. To
approve a BLA, the FDA must determine that the product is safe, pure, and potent
and that the facilities in which the product is manufactured or otherwise
handled meet the applicable standards. In addition to reports of the preclinical
and clinical trials conducted under an IND, an NDA or BLA includes information
pertaining to the product’s safety and efficacy, preparation of the drug
substance, analytical methods, drug product formulation, manufacturing details,
and proposed product packaging and labeling. In addition, the manufacturing
facility must also pass an FDA current Good Manufacturing Practices (“cGMP”)
inspection before the marketing application can be approved.
5
Submission
of an NDA or BLA does not assure FDA approval for marketing. After the
application is submitted, the FDA initially determines whether all pertinent
data and information have been submitted before accepting the application for
filing. After the application is accepted for filing, the FDA begins its
substantive review. The FDA typically will request a review of the data in the
NDA or BLA and recommendation regarding approval by an advisory committee
consisting of outside experts. The FDA may accept or reject the advisory
committee’s recommendations, or accept them with modifications. The application
review process generally takes a year or longer to complete, although reviews of
drugs that meet a medical need for serious or life-threatening diseases may be
accelerated or prioritized for a six-month review. The FDA may deny approval of
an application. Any such denial may require extensive additional testing, which
could take years to complete, in order to make the application approvable, or
the denial may be based on considerations that cannot be favorably resolved
through additional testing. In some circumstances, the FDA may approve an
application even though some unanswered questions remain about the product, if
the applicant agrees to conduct post-marketing studies. The FDA may impose other
conditions of approval as well. Expedited or accelerated approvals may require
additional larger confirmatory clinical studies to be conducted following
approval.
Product
approval may be withdrawn if compliance with regulatory requirements is not
maintained or if post-marketing adverse events associated with the product are
reported that cannot be addressed satisfactorily through changes to the
product’s labeling or warnings to healthcare professionals. The FDA requires
reporting of certain safety and other information that becomes known to a
manufacturer of an approved product. A company may become aware of such
information from reports of adverse events suspected to be related to the
product, voluntarily provided to the company and/or to the FDA by physicians and
other healthcare professionals, or from published scientific data. In some
circumstances, the FDA may require the company to make changes to its approved
product labeling or to issue safety warnings to healthcare professionals or the
public, which may have a negative impact on product sales. In addition, the
Amendments Act of 2007 provides the FDA with expanded authority over drug
products after approval, including the authority to require post-approval
studies and clinical trials, labeling changes based on new safety information,
and compliance with risk evaluation and mitigation strategies, or “REMS”,
approved by the FDA. The FDA’s exercise of this authority could result in delays
or increased costs during the period of product candidate development, clinical
trials and regulatory review and approval, increased costs to assure compliance
with new post-approval regulatory requirements, and potential restrictions on
the sale of approved products, which could lead to lower product revenues to us
or our collaborators. Manufacturing and sales may also be disrupted or delayed
in the event of failure to comply with all required cGMP, as determined by FDA
investigators in periodic inspections of manufacturing facilities. Upon
approval, a drug or biological product may only be marketed for the approved
indications, in the approved dosage forms, and at the approved dosage. The
nature of marketing claims that we will be permitted to make in the labeling and
advertising of our products will be limited to those specified in an FDA
approval.
Other
Regulations
In
addition to laws and regulations enforced by the FDA, we are also subject to
regulation under National Institutes of Health guidelines as well as under the
Controlled Substances Act, the Occupational Safety and Health Act, the
Environmental Protection Act, the Toxic Substances Control Act, the Resource
Conservation and Recovery Act and other present and potential future federal,
state or local laws and regulations, as our research and development may involve
the controlled use of hazardous materials, chemicals, viruses and various
radioactive compounds.
In
addition to regulations in the United States, we are subject to a variety of
foreign regulations governing clinical trials and commercial sales and
distribution of our investigational product candidates. Whether or not we obtain
FDA approval for a product, we must obtain approval of a product by the
comparable regulatory authorities of foreign countries before we can commence
clinical trials or marketing of the product in those countries. The approval
process varies from country to country, and the time may be longer or shorter
than that required for FDA approval. The requirements governing the conduct of
clinical trials, product licensing, pricing and reimbursement vary greatly from
country to country.
Employees
We have
four employees, including three part-time employees. Our Chief Financial
Officer, Richard McKilligan, is a part-time employee and will provide services
as needed. We do not expect any material changes in the number of employees over
the next 12-month period. We do and will continue to outsource contract
employment as needed.
Not
required for smaller reporting companies.
Item
1B. Unresolved Staff Comments
Not
required for smaller reporting companies.
6
Item
2. Properties
We do not
own any real property and do not currently lease office space. Our employees
work out of their homes or out of another employer’s offices with the employer’s
permission. We intend to outsource substantially all of our clinical development
work to contract research and manufacturing providers.
Item
3. Legal Proceedings.
While we
may become involved in various lawsuits and legal proceedings from time to time
arising in the ordinary course of business, we are unaware of any material
pending legal proceedings to which we are a party or of which any of our
property is the subject.
Item 4. (Removed and Reserved).
7
PART
II
Item 5. Market for Common Equity, Related
Stockholder Matters and Issuer Purchases of Equity
Securities.
Our
common stock, par value $0.000041666, is currently quoted on the OTC Bulletin
Board under the symbol “FGGT” however, no active trading market in our
securities has yet commenced. We have requested a new trading symbol from FINRA,
and we expect to be assigned the new symbol shortly after the filing of this
report. As of the date of this report, there were 71,860,008 shares (after
taking into effect our recently completed 24-for-1 forward stock split and our
recent private placement) of our common stock outstanding and approximately 46
holders of record.
We have
not paid any cash dividends since inception to the holders of our common stock.
We currently intend to retain any earnings for internal cash flow
use.
On March
29, 2010, the Board of Directors of the Company adopted the Genesis Biopharma,
Inc. 2010 Equity Compensation Plan. The Board reserved 3,500,000
shares of common stock to be awarded to directors, employees and consultants as
equity compensation at the Board’s discretion.
Item
6. Selected Financial Data
Not
required for smaller reporting companies.
Item
7. Management's Discussion and Analysis of Financial Condition and
Results of Operations
The
following discussion and analysis of our results of operations and financial
condition for the years ended December 31, 2009 and 2008 should be read in
conjunction with our financial statements and the notes to those financial
statements that are included elsewhere in this report. Our discussion includes
forward-looking statements based upon current expectations that involve risks
and uncertainties, such as our plans, objectives, expectations and intentions.
Actual results and the timing of events could differ materially from those
anticipated in these forward-looking statements as a result of a number of
factors, including those set forth under the “Business” section and elsewhere in
this report. We use words such as “anticipate,” “estimate,” “plan,” “project,”
“continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,”
“could,” and similar expressions to identify forward-looking statements. All
forward-looking statements included in this report are based on information
available to us on the date hereof and, except as required by law, we assume no
obligation to update any such forward-looking statements.
Overview
Genesis
Biopharma, Inc. (formerly named Freight Management Corp.) (“we” or the
“Company”) was incorporated in the State of Nevada on September 17, 2007 to
engage in the development of an internet-based, intelligent online system for
business owners, freight forwarders, and business people in the shipping/freight
industry and export/import industry who require assistance with their freight
and shipping related inquiries. On March 15, 2010, the Company and Genesis
Biopharma, Inc., a Nevada corporation and a newly formed merger subsidiary
wholly owned by the Company (“Merger Sub”), consummated a merger transaction
(the “Merger”) whereby Merger Sub merged into the Company, with the Company as
the surviving corporation. The Company and Merger Sub filed Articles of Merger
on March 15, 2010 with the Secretary of State of Nevada, along with the
Agreement and Plan of Merger entered into by the two parties effective as of
March 15, 2010 (the “Merger Agreement”). The Merger Agreement and the Articles
of Merger provided for an amendment of the Company’s Articles of Incorporation,
which changed the Company’s name to “Genesis Biopharma, Inc.” effective as of
March 15, 2010.
As a
result of the Merger, the Company acquired all of the assets and contractual
rights, and assumed all of the liabilities, of Merger Sub with respect to an
Asset Purchase Agreement (the “Purchase Agreement”) entered into effective March
15, 2010, by the Company and Merger Sub with Hamilton Atlantic, a Cayman Islands
company (“Hamilton”), whereby Hamilton sold, and Merger Sub acquired, all of
Hamilton’s rights, title and interest to certain assets related to the
development and commercialization of biotechnology drugs, primarily anti-CD55
antibodies (the “Anti-CD55 Antibody Program”), including certain patents, patent
applications, materials, and know-how. The Anti-CD55 Antibody Program consists
of antibodies that could be developed and commercialized for the treatment of
cancer. As consideration, the Company agreed to issue to Hamilton 20,960,016
shares of the Company’s common stock.
8
On March
15, 2010, after the effectiveness of the Merger, we entered into a Patent and
Know How Licence (the “License Agreement”) with Cancer Research Technology
Limited, a company registered in England and Wales (“CRT”). Pursuant to the
License Agreement, CRT granted to the Company an exclusive, worldwide right and
license in certain intellectual property related to a proprietary, therapeutic
use of anti-CD55 antibodies, including rights to patents and patent applications
related thereto, to research, develop, use, make, distribute, and sell products
utilizing the licensed intellectual property. The license granted to the Company
expires on the later to occur of the expiration of the relevant licensed patent
in the relevant country or 10 years after the date that the first therapeutic
product was placed on the market in such country. In consideration for the
license, the Company agreed to pay to CRT GBP30,000 in royalties upon the
effective date of the License Agreement. In addition, the Company agreed to pay
CRT additional royalties based on the achievement of certain milestones,
including the consummation of financing by the Company and other milestones
relating to the commencement of Phase III clinical studies, the filing of new
drug applications, and the grant of marketing approval related to the licensed
products.
As a
result of our recent acquisition of the assets related to the Anti-CD55 Antibody
Program and the License Agreement, we have become a biopharmaceutical company
engaged in the development and commercialization of drugs and other clinical
solutions for underserved diseases, including metastatic cancers and lethal
infectious diseases.
Results
of Operations
Year
Ended December 31, 2009 Compared to the Year Ended December 31,
2008:
Operating
Expenses
General
and Administrative
Our
general and administrative expenses decreased 44% from $25,558 for the year
ended December 31, 2008 to $14,440 for the year ended December 31, 2009. These
expenses include rent and the expenses related to the Company’s SEC
filings. We expect these expenses to increase substantially during
the 2010 fiscal year as we implement our plan to develop our
products.
Database
Development Cost
Our
database development costs decreased from $30,250 for the year ended December
31, 2008, to $0, a decrease of 100%. These costs were associated with
the development of the freight management system and we do not expect to incur
any of these expenses in the future.
Amortization
Our
amortization expense remained at $1,332, for each of the years ended December
31, 2009 and 2008. This expense is related to the Freight Management
website. We expect depreciation and amortization expenses to increase
as we invest in a new website and various other intellectual
property.
Net
Loss
We had a
net loss of $57,140 for the year ended December 31, 2008 compared to a net loss
of $15,772 for the year ended December 31, 2009. As we are a
development stage company and do not expect to earn significant revenues during
the next fiscal year, we expect to continue to incur net losses and we expect
those losses to increase during the 2010 fiscal year as we incur significant
expenses to develop our products.
Liquidity
and Capital Resources
Since our
inception, we have funded our operations primarily through private sales of
equity securities and loans from a director. Effective March 15, 2010, the
Company sold to accredited investors pursuant to subscription agreements, in a
private placement offering, an aggregate of 12,799,968 shares (post-split) of
its common stock, for an aggregate purchase price of $400,000. We
expect to issue additional shares and possibly incur debt
As of
December 31, 2009, we had cash of $8,257.
Net cash
provided by operating activities was $5,352 for the year ended December 31, 2009
compared to net cash used in operating activities of $57,303 for the year ended
December 31, 2008. This difference was primarily due to a larger net
loss in the 2008 period.
Effective
March 15, 2010, the Company sold to accredited investors pursuant to
subscription agreements, in a private placement offering, an aggregate of
12,799,968 shares (post-split) of its common stock, for an aggregate purchase
price of $400,000.
We
believe that our current cash resources will be sufficient to sustain our
current operations for approximately six (6) months. We will
need to obtain additional cash resources during the next year in order to
develop our products. We expect to engage in additional sales of debt
or equity securities. The sale of additional equity or convertible debt
securities would result in additional dilution to our shareholders. The issuance
of additional debt would result in increased expenses and could subject us to
covenants that may have the effect of restricting our operations. We have not
made arrangements to obtain additional financing and we can provide no assurance
that additional financing will be available in an amount or on terms acceptable
to us, if at all.
9
Critical
Accounting Policies
Our
discussion and analysis of our financial condition and results of operations are
based upon our consolidated financial statements and accompanying notes, which
have been prepared in accordance with accounting principles generally accepted
in the United States. The preparation of these financial statements requires
management to make estimates and assumptions that affect the reported amounts of
assets, liabilities, revenue and expenses, and related disclosure of contingent
assets and liabilities. When making these estimates and assumptions, we consider
our historical experience, our knowledge of economic and market factors and
various other factors that we believe to be reasonable under the circumstances.
Actual results may differ under different estimates and
assumptions.
The
accounting estimates and assumptions discussed in this section are those that we
consider to be the most critical to an understanding of our financial statements
because they inherently involve significant judgments and
uncertainties.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosures of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenue and expenses during
the reporting periods. Actual results could differ from these
estimates.
Revenue
Recognition
The
Company applies the provisions of the Securities and Exchange Commission (“SEC”)
Staff Accounting Bulletin (SAB) No. 104, “Revenue Recognition in Financial
Statements,” which provides guidance on the recognition, presentation and
disclosure of revenue in financial statements filed with the SEC. SAB No. 104
outlines the basic criteria that must be met to recognize revenue and provides
guidance for disclosure related to revenue recognition policies. In general, the
Company recognizes revenue when (i) persuasive evidence of an arrangement
exists, (ii) shipment of products has occurred or services have been rendered,
(iii) the sales price charged is fixed or determinable and (iv) collection is
reasonably assured.
The
Company has not recognized any revenue to date and we do not anticipate
recognizing any significant revenue during the next fiscal year.
Impairment
of Long-lived Assets
SFAS No.
144, “Accounting for the Impairment or Disposal of Long-Lived Assets,” requires
that long-lived assets to be disposed of by sale, including those of
discontinued operations, be measured at the lower of carrying amount or fair
value less cost to sell, whether reported in continuing operations or in
discontinued operations. SFAS No. 144 broadens the reporting of discontinued
operations to include all components of an entity with operations that can be
distinguished from the rest of the entity and that will be eliminated from the
ongoing operations of the entity in a disposal transaction. SFAS No. 144 also
establishes a `primary-asset` approach to determine the cash flow estimation
period for a group of assets and liabilities that represents the unit of
accounting for a long-lived asset to be held and used. The Company has no
impairment issues to disclose.
Stock
Based Compensation
The
Company adopted SFAS No. 123 (Revised 2004), “Share Based Payment” (“SFAS No.
123R”). SFAS No. 123R requires companies to measure and recognize the cost of
employee services received in exchange for an award of equity instruments based
on the grant-date fair value. SFAS No. 123R eliminates the ability to account
for the award of these instruments under the intrinsic value method prescribed
by Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock
Issued to Employees,” and allowed under the original provisions of SFAS No. 123.
As of December 31, 2009, the Company had no employee options
outstanding.
Recent
Accounting Pronouncements
In June
2009, the FASB issued authoritative guidance on accounting standards
codification and the hierarchy of generally accepted accounting principles
(“GAAP") effective for interim and annual reporting periods ending after
September 15, 2009. The FASB accounting standards codification
(“Codification”) has become the source of authoritative accounting principles
recognized by the FASB to be applied by nongovernmental entities in the
preparation of financial statements in accordance with GAAP. All existing
accounting standard documents are superseded by the Codification and any
accounting literature not included in the Codification will not be
authoritative. However, rules and interpretive releases of the SEC issued under
the authority of federal securities laws will continue to be sources of
authoritative GAAP for SEC registrants. Beginning with the
quarter ending September 30, 2009, all references made by the Company to GAAP in
its condensed consolidated financial statements use the Codification numbering
system. The Codification does not change or alter existing GAAP and, therefore,
it does not have an impact on our financial position, results of operations and
cash flows.
10
In
June 2009, the FASB made an updated the principle for the consolidation of
variable interest entities. Among other things, the update replaces the
calculation for determining which entities, if any, have a controlling financial
interest in a variable interest entity (“VIE”) from a quantitative based risks
and rewards calculation, to a qualitative approach that focuses on identifying
which entities have the power to direct the activities that most significantly
impact the VIE’s economic performance and the obligation to absorb losses of the
VIE or the right to receive benefits from the VIE. The update also requires
ongoing assessments as to whether an entity is the primary beneficiary of a VIE
(previously, reconsideration was only required upon the occurrence of specific
events), modifies the presentation of consolidated VIE assets and liabilities,
and requires additional disclosures about a company’s involvement in VIE’s. This
update will be effective for fiscal years beginning after November 15,
2009. The Company does not currently believe that the adoption of this update
will have any effect on its consolidated financial position and results of
operations.
In
October 2009, the FASB issued authoritative guidance on revenue recognition that
will become effective for us beginning July 1, 2010, with earlier adoption
permitted. Under the new guidance on arrangements that include software
elements, tangible products that have software components that are essential to
the functionality of the tangible product will no longer be within the scope of
the software revenue recognition guidance, and software-enabled products will
now be subject to other relevant revenue recognition guidance. Additionally, the
FASB issued authoritative guidance on revenue arrangements with multiple
deliverables that are outside the scope of the software revenue recognition
guidance. Under the new guidance, when vendor specific objective evidence or
third party evidence for deliverables in an arrangement cannot be determined, a
best estimate of the selling price is required to separate deliverables and
allocate arrangement consideration using the relative selling price method. The
new guidance includes new disclosure requirements on how the application of the
relative selling price method affects the timing and amount of revenue
recognition. We believe the adoption of this new guidance will
not have a material impact on our financial statements.
Other
recent accounting pronouncements issued by the FASB (including its Emerging
Issues Task Force), the AICPA, and the SEC did not or are not believed by
management to have a material impact on the Company's present or future
consolidated financial statements.
At
December 31, 2009, we had no obligations that would require disclosure as
off-balance sheet arrangements.
Item
7A. Quantitative and Qualitative Disclosures About Market Risk
Not
required for smaller reporting companies.
11
Item
8. Financial Statements and Supplementary Data
Report
of Independent Registered Public Accounting Firm
To the
Board of Directors
Freight
Management Corp.
(a
Development Stage Company)
1601 N.
Sepulveda Blvd. #632
Manhattan
Beach, CA 90266
We have
audited the balance sheet of Freight Management Corp. (a development stage
company) as of December 31, 2009, and the related statement of operations,
stockholders’ deficit and cash flows for the year ended December 31, 2009 and
for the period September 17, 2007 (inception) to December 31,
2009. These financial statements are the responsibility of the
Company’s management. Our responsibility is to express an opinion on these
financial statements based on our audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require
that we plan and perform the audit to obtain reasonable assurance about whether
the financial statements are free of material misstatement. The
Company is not required to have, nor were we engaged to perform, an audit of its
internal control over financial reporting. Our audit included
consideration of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the circumstances, but not
for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no
such opinion. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and significant estimates
made by management, as well as evaluating the overall financial statement
presentation. We believe that our audit provides a reasonable basis
for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Freight Management Corp. (a
development stage company) at December 31, 2009, and the results of its
operations and its cash flows for the year ended December 31, 2009, for the
period September 17, 2007 (inception) to December 31, 2009, in conformity with
accounting principles generally accepted in the United States of
America.
The
accompanying financial statements have been prepared assuming Freight Management
Corp. (a development stage company) will continue as a going
concern. The Company incurred a loss for the year ended December 31,
2009 and has a stockholders’ deficiency at December 31, 2009. These
conditions raise substantial doubt regarding the Company's ability to continue
as a going concern. Management's plans in regard to these matters are
described in Note 3 to the financial statements. The financial
statements do not include any adjustments to reflect the possible future effects
on the recoverability and classification of assets or the amounts and
classification of liabilities that may result from the outcome of this
uncertainty.
Weinberg
& Company, P.A.
Los
Angeles, California
March 29,
2010
12
SEALE
AND BEERS, CPAs
PCAOB & CPAB REGISTERED
AUDITORS
www.sealebeers.com
REPORT OF INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors
Freight
Management Corporation
(A
Development Stage Company)
We have
audited the accompanying balance sheets of Freight Management Corporation (A
Development Stage Company) as of December 31, 2008 and 2007, and the related
statements of operations, stockholders’ equity (deficit) and cash flows for the
year ended December 31, 2008 and the period from inception on September 17, 2007
through December 31, 2007 and 2008. These financial statements are the
responsibility of the Company’s management. Our responsibility is to
express an opinion on these financial statements based on our
audits.
We
conduct our audits in accordance with standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan
and perform the audits to obtain reasonable assurance about whether the
financial statements are free of material misstatement. An audit
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis
for our opinion.
In our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of Freight Management Corporation (A
Development Stage Company) as of December 31, 2008 and 2007, and the related
statements of operations, stockholders’ equity and cash flows for the year ended
December 31, 2008 and the period from inception on September 17, 2007 through
December 31, 2007 and 2008, in conformity with accounting principles generally
accepted in the United States of America.
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 3 to the
financial statements, the Company has an accumulated deficit of $58,716, which
raises substantial doubt about its ability to continue as a going
concern. Management’s plans concerning these matters are also
described in Note 3. The financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
/s/
Seale and Beers, CPAs
Seale and
Beers, CPAs
Las
Vegas, Nevada
August
20, 2009
50 South Jones Blvd, Ste
202 Las Vegas,
Nevada 89107 Ph: 888-727-8251 Fx: 888-782-2351
13
GENESIS
BIOPHARMA, INC.
(FORMERLY
FREIGHT MANAGEMENT CORP.)
(A
Development Stage Company)
BALANCE
SHEETS
December
31, 2009
|
December
31, 2008
|
|||||||
ASSETS
|
||||||||
Current
assets
|
||||||||
Cash
|
$ | 8,257 | $ | 2,905 | ||||
Deposit
|
150 | 150 | ||||||
Total
current assets
|
8,407 | 3,055 | ||||||
Website,
net of accumulated amortization
|
1,225 | 2,557 | ||||||
Total
assets
|
$ | 9,632 | $ | 5,612 | ||||
LIABILITIES
AND STOCKHOLDERS’ DEFICIT
|
||||||||
Current
liabilities
|
||||||||
Accounts
payable and accrued liabilities
|
$ | - | $ | 8 | ||||
Due
to director
|
23,120 | 3,320 | ||||||
Total
current liabilities
|
23,120 | 3,328 | ||||||
Stockholders’
deficit
|
||||||||
Common
Stock, par value $0.000041666; Authorized: 1,800,000,000
shares
|
||||||||
Issued
and outstanding: 121,440,000 shares
|
5,060 | 5,060 | ||||||
Additional
paid-in capital
|
55,940 | 55,940 | ||||||
Deficit
accumulated during the development stage
|
(74,488 | ) | (58,716 | ) | ||||
Total
stockholders’ deficit
|
(13,488 | ) | 2,284 | |||||
Total
liabilities and stockholders' deficit
|
$ | 9,632 | $ | 5,612 |
The
accompanying notes are an integral part of these financial
statements.
14
GENESIS
BIOPHARMA, INC.
(FORMERLY
FREIGHT MANAGEMENT CORP.)
(A
Development Stage Company)
STATEMENTS OF
OPERATIONS
Year
Ended
December
31, 2009
|
Year
Ended
December
31, 2008
|
Date
of
Incorporation
on
September 17, 2007 to
December
31, 2009
|
||||||||||
REVENUE
|
$ | - | $ | - | $ | - | ||||||
OPERATING
EXPENSES
|
||||||||||||
Amortization
|
1,332 | 1,332 | 2,775 | |||||||||
Database
development costs
|
- | 30,250 | 30,250 | |||||||||
General
& administrative
|
14,440 | 25,558 | 40,643 | |||||||||
Organization
|
- | - | 820 | |||||||||
Net
loss
|
$ | (15,772 | ) | $ | (57,140 | ) | $ | (74,488 | ) | |||
Basic
and diluted loss per common
share
|
$ | * | $ | (0.01 | ) | |||||||
Weighted
average number of
common shares outstanding
(Note 4)
|
121,440,000 | 121,440,000 |
*
|
less
than $ (0.01)
|
The
accompanying notes are an integral part of these financial
statements.
15
GENESIS
BIOPHARMA, INC.
(FORMERLY
FREIGHT MANAGEMENT CORP.)
(A
Development Stage Company)
STATEMENTS OF STOCKHOLDERS'
DEFICIT
Common
Stock
|
Additional
|
Deficit
Accumulated
During
the
|
Total
|
|||||||||||||||||
Shares
|
Amount
|
Paid
in
Capital
|
Development
Stage
|
Stockholders'
Deficit
|
||||||||||||||||
Initial
capitalization, sale of common stock to Directors on September 17,
2007
|
96,000,000 | $ | 4,000 | $ | 4,000 | $ | $ | 8,000 | ||||||||||||
Private
placement closed December 31, 2007
|
25,440,000 | 1,060 | 51,940 | 53,000 | ||||||||||||||||
Net
loss for the period
|
- | - | - | (1,576 | ) | (1,576 | ) | |||||||||||||
Balance
December 31, 2007
|
121,440,000 | 5,060 | 55,940 | (1,576 | ) | 59,424 | ||||||||||||||
Net
loss for the period
|
- | - | - | (57,140 | ) | (57,140 | ) | |||||||||||||
Balance
December 31, 2008
|
121,440,000 | 5,060 | 55,940 | (58,716 | ) | 2,284 | ||||||||||||||
Net
loss for the year
|
- | - | - | (15,772 | ) | (15,772 | ) | |||||||||||||
Balance
December 31, 2009
|
121,440,000 | $ | 5,060 | $ | 55,940 | $ | (74,488 | ) | $ | (13,488 | ) |
The
accompanying notes are an integral part of these financial
statements.
16
GENESIS
BIOPHARMA, INC.
(FORMERLY
FREIGHT MANAGEMENT CORP.)
(A
Development Stage Company)
STATEMENTS OF CASH
FLOWS
Year
Ended
December
31, 2009
|
Year
Ended
December
31, 2008
|
Date
of
Incorporation
on
September 17, 2007 to
December
31, 2009
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss for the period
|
$ | (15,772 | ) | $ | (57,140 | ) | $ | (74,488 | ) | |||
Adjustments
To Reconcile Net Loss To Net Cash Used In Operating
Activities
|
||||||||||||
Amortization
expense
|
1,332 | 1,332 | 2,775 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Deposit
|
- | - | (150 | ) | ||||||||
Accounts
payable and accrued liabilities
|
(8 | ) | (3,995 | ) | - | |||||||
Net
cash provided by (used in) operating activities
|
(14,448 | ) | (59,803 | ) | (71,863 | ) | ||||||
INVESTING
ACTIVITIES
|
||||||||||||
Website
|
- | - | (4,000 | ) | ||||||||
Net
cash used in investing activities
|
- | - | (4,000 | ) | ||||||||
FINANCING
ACTIVITIES
|
||||||||||||
Due
to director
|
19,800 | 2,500 | 23,120 | |||||||||
Proceeds
from issuance of common stock
|
- | - | 61,000 | |||||||||
Net
cash provided by financing activities
|
19,800 | 2,500 | 84,120 | |||||||||
Increase
(decrease) in cash during the period
|
5,352 | (57,303 | ) | 8,257 | ||||||||
Cash,
beginning of the period
|
2,905 | 60,208 | - | |||||||||
Cash,
end of the period
|
$ | 8,257 | $ | 2,905 | $ | 8,257 | ||||||
Supplemental
disclosure with respect to cash flows:
|
||||||||||||
Cash
paid for income taxes
|
$ | - | $ | - | $ | - | ||||||
Cash
paid for interest
|
$ | - | $ | - | $ | - |
The
accompanying notes are an integral part of these financial
statements.
17
GENESIS
BIOPHARMA, INC.
(FORMERLY
FREIGHT MANAGEMENT CORP.)
(A
Development Stage Company)
NOTES TO FINANCIAL
STATEMENTS
For the
Years Ended December 31, 2009 and 2008
and the
Period from September 17, 2007 to December 31, 2007
NOTE 1. GENERAL ORGANIZATION
AND BUSINESS
The
Company was originally incorporated under the laws of the state of Nevada on
September 17, 2007. The Company has limited operations is considered a
development stage company, and has had no revenues from operations to
date. The Company has adopted a December 31 year end.
Initial
operations included organization, capital formation, target market
identification, new product development and marketing plans.
On March
15, 2010, the Company and Genesis Biopharma, Inc., a Nevada corporation and a
newly formed merger subsidiary wholly owned by the Company (“Merger Sub”),
consummated a merger transaction (the “Merger”) whereby Merger Sub merged into
the Company, with the Company as the surviving corporation. The
Company and Merger Sub filed the Articles of Merger on March 15, 2010 with the
Secretary of State of Nevada, along with the Agreement and Plan of Merger
entered into by the two parties effective as of March 15, 2010 (the “Merger
Agreement”). The Merger Agreement and the Articles of Merger provided
for an amendment of the Company’s Articles of Incorporation, which changed the
Company’s name to “Genesis Biopharma, Inc.” effective as of March 15, 2010. (see
Note 5)
On March
15, 2010, the Company also effected a 24−for−1 forward stock split, with a
record date of March 15, 2010, and correspondingly increased the number of its
authorized shares to 1,800,000,000 and reduced the par value of each share from
$0.001 to $0.000041666. All share and per share amounts have been
retroactively restated as if the stock split had occurred during the earliest
period presented.
Going
Concern
The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern, which contemplates, among other things, the
realization of assets and satisfaction of liabilities in the normal course of
business. The Company has net losses for the period from inception to December
31, 2009 of $74,488. The Company intends to fund operations through sales and
equity financing arrangements, which may be insufficient to fund its capital
expenditures, working capital and other cash requirements through the next
fiscal year ending December 31, 2010.
These
factors, among others, raise substantial doubt about the Company’s ability to
continue as a going concern. These financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
18
NOTE 2. SUMMARY
OF SIGNIFICANT ACCOUNTING PRACTICES
Earnings
per Share
The basic
earnings (loss) per share is calculated by dividing the Company’s net income
available to common shareholders by the weighted average number of common shares
during the year. The diluted earnings (loss) per share is calculated by dividing
the Company’s net income (loss) available to common shareholders by the diluted
weighted average number of shares outstanding during the year. The diluted
weighted average number of shares outstanding is the basic weighted number of
shares adjusted as of the first of the year for any potentially dilutive debt or
equity.
On March
30, 2010, the Company granted options to purchase 675,000 shares of the
Company’s common stock to a director and two consultants at an exercise price of
$0.03125. These options vest over three (3) years.
Dividends
The
Company has not yet adopted any policy regarding payment of dividends. No
dividends have been paid during the periods shown.
Fair
Value of Financial Instruments
The
Company estimates the fair value of financial instruments using the available
market information and valuation methods. Considerable judgment is required in
estimating fair value. Accordingly, the estimates of fair value may not be
indicative of the amounts the Company could realize in a current market
exchange. As of December 31, 2009, the carrying value of accrued
liabilities approximated fair value due to the short-term nature and maturity of
these instruments.
Income
Taxes
Income
taxes are provided in accordance with guidance of the Financial Accounting
Standards Board (“FASB”). A deferred tax asset or liability is
recorded for all temporary differences between financial and tax reporting and
net operating loss carryforwards. Deferred tax expense (benefit)
results from the net change during the year of deferred tax assets and
liabilities. Deferred tax assets are reduced by a valuation allowance when, in
the opinion of management, it is more likely than not that some portion of all
of the deferred tax assets will be realized. Deferred tax assets and
liabilities are adjusted for the effects of changes in tax laws and rates on the
date of enactment.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenue and expenses during
the reporting period. Actual results could differ from those
estimates.
Website
Costs
Costs
incurred in connection with the creation of our website have been capitalized
and are being amortized to expense over their estimated useful life of three
years using the straight-line method.
Ongoing
website post-implementation costs of operation, including training, application
maintenance and creation of database content, will be charged to expense as
incurred.
Recent
Accounting Pronouncements
In June
2009, the FASB issued authoritative guidance on accounting standards
codification and the hierarchy of generally accepted accounting principles
(“GAAP") effective for interim and annual reporting periods ending after
September 15, 2009. The FASB accounting standards codification
(“Codification”) has become the source of authoritative accounting principles
recognized by the FASB to be applied by nongovernmental entities in the
preparation of financial statements in accordance with GAAP. All existing
accounting standard documents are superseded by the Codification and any
accounting literature not included in the Codification will not be
authoritative. However, rules and interpretive releases of the SEC issued under
the authority of federal securities laws will continue to be sources of
authoritative GAAP for SEC registrants. Beginning with the
quarter ending September 30, 2009, all references made by the Company to GAAP in
its condensed consolidated financial statements use the Codification numbering
system. The Codification does not change or alter existing GAAP and, therefore,
it does not have an impact on our financial position, results of operations and
cash flows.
19
In
June 2009, the FASB made an updated the principle for the consolidation of
variable interest entities. Among other things, the update replaces the
calculation for determining which entities, if any, have a controlling financial
interest in a variable interest entity (VIE) from a quantitative based risks and
rewards calculation, to a qualitative approach that focuses on identifying which
entities have the power to direct the activities that most significantly impact
the VIE’s economic performance and the obligation to absorb losses of the VIE or
the right to receive benefits from the VIE. The update also requires ongoing
assessments as to whether an entity is the primary beneficiary of a VIE
(previously, reconsideration was only required upon the occurrence of specific
events), modifies the presentation of consolidated VIE assets and liabilities,
and requires additional disclosures about a company’s involvement in VIE’s. This
update will be effective for fiscal years beginning after November 15,
2009. The Company does not currently believe that the adoption of this update
will have any effect on its consolidated financial position and results of
operations.
In
October 2009, the FASB issued authoritative guidance on revenue recognition that
will become effective for us beginning July 1, 2010, with earlier adoption
permitted. Under the new guidance on arrangements that include software
elements, tangible products that have software components that are essential to
the functionality of the tangible product will no longer be within the scope of
the software revenue recognition guidance, and software-enabled products will
now be subject to other relevant revenue recognition guidance. Additionally, the
FASB issued authoritative guidance on revenue arrangements with multiple
deliverables that are outside the scope of the software revenue recognition
guidance. Under the new guidance, when vendor specific objective evidence or
third party evidence for deliverables in an arrangement cannot be determined, a
best estimate of the selling price is required to separate deliverables and
allocate arrangement consideration using the relative selling price method. The
new guidance includes new disclosure requirements on how the application of the
relative selling price method affects the timing and amount of revenue
recognition. We believe the adoption of this new guidance will
not have a material impact on our financial statements.
Other
recent accounting pronouncements issued by the FASB (including its Emerging
Issues Task Force), the AICPA, and the SEC did not or are not believed by
management to have a material impact on the Company's present or future
consolidated financial statements.
NOTE 3. STOCKHOLDERS’
EQUITY
Authorized
The
Company is authorized to issue 1,800,000,000 shares of $0.000041666 par value
common stock. All common stock shares have equal voting rights, are
non-assessable and have one vote per share. Voting rights are not cumulative
and, therefore, the holders of more than 50% of the common stock could, if they
choose to do so, elect all of the directors of the Company.
On March
15, 2010, the Company effected a 24−for−1 forward stock split, with a record
date of March 15, 2010, and correspondingly increased the number of its
authorized shares to 1,800,000,000 and reduced the par value of each share from
$0.001 to $0.000041666.
Issued
and Outstanding
On
September 17, 2007 (inception), the Company issued 96,000,000 shares of its
common stock to its Directors, at a price of $0.00083 per share, for cash of
$8,000. See Note 4.
20
On
December 31, 2007, the Company closed a private placement for 25,440,000 common
shares at a price of $0.002083 per share, or an aggregate of $53,000. The
Company accepted subscriptions from 39 offshore non-affiliated
investors.
NOTE 4. RELATED PARTY
TRANSACTIONS
The
Company's neither owns nor leases any real or personal property. The Company’s
Directors provide office space free of charge. The officers and directors of the
Company are involved in other business activities and may, in the future, become
involved in other business opportunities. If a specific business opportunity
becomes available, such persons may face a conflict in selecting between the
Company and their other business interests. The Company has not formulated a
policy for the resolution of such conflicts.
The
amount due to a director of $23,120 has no repayment terms, is unsecured without
interest and is for reimbursement of company incorporation and general operating
expenses. The Company plans to pay the amount within the next 12 months, if it
has sufficient cash to do so.
NOTE
5. SUBSEQUENT EVENTS
On March
15, 2010, the Company and Genesis Biopharma, Inc., a Nevada corporation and a
newly formed merger subsidiary wholly owned by the Company (“Merger Sub”),
consummated a merger transaction (the “Merger”) whereby Merger Sub merged into
the Company, with the Company as the surviving corporation. The
Company and Merger Sub filed the Articles of Merger on March 15, 2010 with the
Secretary of State of Nevada, along with the Agreement and Plan of Merger
entered into by the two parties effective as of March 15, 2010 (the “Merger
Agreement”). The Merger Agreement and the Articles of Merger provided
for an amendment of the Company’s Articles of Incorporation, which changed the
Company’s name to “Genesis Biopharma, Inc.” effective as of March 15,
2010.
On March
15, 2010, the Company also effected a 24−for−1 forward stock split, with a
record date of March 15, 2010, and correspondingly increased the number of its
authorized shares to 1,800,000,000 and reduced the par value of each share from
$0.001 to $0.000041666.
As a
result of the merger with Merger Sub, the Company acquired all of the assets and
contractual rights, and assumed all of the liabilities, of Merger Sub with
respect to an Asset Purchase Agreement (the “Purchase
Agreement”). Effective March 15, 2010, the Company and Merger Sub
entered into the Purchase Agreement with Hamilton Atlantic, a Cayman Islands
company (“Hamilton”), whereby Hamilton sold, and Merger Sub acquired, all of
Hamilton’s rights, title and interest to certain assets related to the
development and commercialization of biotechnology drugs, primarily anti-CD55
antibodies (the “Anti-CD55 Antibody Program”), including certain patents, patent
applications, materials, and know-how. The Anti-CD55 Antibody Program
consists of antibodies that could be developed and commercialized for the
treatment of cancer. As consideration, the Company agreed to issue to
Hamilton 20,960,016 shares of the Company’s common stock.
21
On March
15, 2010, after the effectiveness of the Merger, we entered into a Patent and
Know How Licence (the “License Agreement”) with Cancer Research Technology
Limited, a company registered in England and Wales (“CRT”). Pursuant
to the License Agreement, CRT granted to the Company an exclusive, worldwide
right and license in certain intellectual property related to a proprietary,
therapeutic use of anti-CD55 antibodies, including rights to patents and patent
applications related thereto, to research, develop, use, make, distribute, and
sell products utilizing the licensed intellectual property. The
license granted to the Company expires on the later to occur of the expiration
of the relevant licensed patent in the relevant country or 10 years after the
date that the first therapeutic product was placed on the market in such
country. In consideration for the license, the Company agreed to pay
to CRT £30,000 in royalties upon the effective date of the License
Agreement. In addition, the Company agreed to pay CRT additional
royalties based on the achievement of certain milestones, including the
consummation of financing by the Company and other milestones relating to the
commencement of Phase III clinical studies, the filing of new drug applications,
and the grant of marketing approval related to the licensed
products.
Effective
March 15, 2010, the Company sold to accredited investors pursuant to
subscription agreements, in a private placement offering (the “Private
Placement”), an aggregate of 12,799,968 shares (post-split) of its common stock
(the “Shares”), for an aggregate purchase price of $400,000. The
Common Stock Subscription Agreements granted the investors “piggy-back”
registration rights with respect to the Shares, pursuant to which the Company
agreed, in the event the Company determines to register its common stock with
the SEC, that it would include as part of the registration statement registering
its common stock the Shares.
The
securities sold by the Company in the Private Placement were exempt from
registration under the Securities Act of 1933, as amended, pursuant to
Regulation S promulgated thereunder and pursuant to Section 4(2)
thereunder.
22
Item
9. Changes in and Disagreements With Accountants on Accounting and
Financial Disclosure
On August
6, 2009, Board of Directors of the Company dismissed Moore & Associates
Chartered, its independent registered public accounting firm. On the same date,
the accounting firm of Seale and Beers, CPAs was engaged as the Company’s new
independent registered public accounting firm. The Board of Directors of the
Company approved of the dismissal of Moore & Associates Chartered and the
engagement of Seale and Beers, CPAs as its independent auditor. None of the
reports of Moore & Associates Chartered on the Company’s financial
statements for either of the past two years or subsequent interim period
contained an adverse opinion or disclaimer of opinion, or was qualified or
modified as to uncertainty, audit scope or accounting principles, except that
the Company’s audited financial statements for the fiscal year ended December
31, 2008 included a going concern qualification..
During
the Company’s two most recent fiscal years, there were no disagreements with
Moore and Associates, Chartered whether or not resolved, on any matter of
accounting principles or practices, financial statement disclosure, or auditing
scope or procedure, which, if not resolved to Moore and Associates, Chartered’s
satisfaction, would have caused it to make reference to the subject matter of
the disagreement in connection with its report on the Company’s financial
statements, and (ii) no “reportable events” as that term is defined in Item
304(a)(1)(v) of Regulation S-K.
On August
6, 2009, the Company engaged Seale and Beers, CPAs (“Seale”) as its independent
registered public accounting firm On March 5, 2010, our Board of
Directors approved the dismissal of Seale as our
independent registered public accounting firm and the engagement of
Weinberg & Company as our
new independent registered public accounting
firm.
Other
than a going concern qualification, Seale’s audit reports on our financial
statements as of and for the year ended December 31, 2008, and for the period of
inception on September 17, 2007 to December 31, 2007, did not contain
an adverse opinion or a disclaimer of opinion and were not qualified or modified
as to uncertainty, audit scope or accounting principles.
During
the year ended December 31, 2008, and for the period of inception on September
17, 2007 to December 31, 2007, the subsequent interim periods, and through March
5, 2010, there were (i)
no disagreements between the Company and Seale on any
matter of accounting principles or practices, financial statement
disclosure or auditing scope or procedure, which disagreements, if
not resolved to the satisfaction of Seale, would have caused Seale to make
reference to the subject matter of the disagreement in their reports on the
financial statements for such years, and (ii) no “reportable events” as that
term is defined in Item 304(a)(1)(v) of Regulation S-K.
During
the year last two fiscal years there were (i) no disagreements
between the Company and Weinberg & Company on any matter of accounting
principles or practices, financial statement disclosure or
auditing scope or procedure, which
disagreements, if not resolved to the satisfaction of Weinberg & Company,
would have caused Weinberg & Company to make reference to the subject matter
of the disagreement in their reports on the financial statements for such years,
and (ii) no “reportable events” as that term is defined in Item 304(a)(1)(v) of
Regulation S-K.
Item
9A(T). Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
The
Company’s management, with the participation of its Chief Executive Officer and
Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure
controls and procedures as of the end of the period covered by this Annual
Report on Form 10-K. For purposes of this section, the term disclosure controls and
procedures means controls and other procedures of an issuer that are
designed to ensure that information required to be disclosed by the issuer in
the reports that it files or submits under the Securities Exchange Act of 1934,
as amended (the “Exchange Act”), is recorded, processed, summarized and reported
within the time periods specified in the SEC’s rules and forms. Disclosure
controls and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed by an issuer in the
reports that it files or submits under the Exchange Act is accumulated and
communicated to the issuer's management, including its principal executive and
principal financial officers, or persons performing similar functions, as
appropriate to allow timely decisions regarding required
disclosure.
23
Based on
this evaluation, the Company’s Chief Executive Officer and Chief Financial
Officer have concluded that as of December 31, 2009, the Company’s disclosure
controls and procedures were effective to ensure that information it is required
to disclose in reports that it files or submits under the Exchange Act is
accumulated and communicated to the Company’s management, including its
principal executive and principal financial officers, as appropriate to allow
timely decisions regarding required disclosure, and that such information is
recorded, processed, summarized and reported within the time periods specified
in SEC rules and forms.
Management’s
Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting. Internal control over financial
reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the
Securities Exchange Act of 1934 as a process designed by, or under the
supervision of, the company's principal executive and principal
financial officers and effected by the company's board of directors, management
and other personnel, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with accounting
principles generally accepted in the United States of America and
includes those policies and procedures that:
*
|
Pertain
to the maintenance of records that in reasonable detail accurately and
fairly reflect the transactions and dispositions of the assets of the
company;
|
*
|
Provide
reasonable assurance that transactions are recorded as
necessary to permit preparation of financial statements in accordance with
accounting principles generally accepted in the United States of America
and that receipts and expenditures of the company are being made only in
accordance with authorizations of management and directors of the company;
and
|
*
|
Provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the company's assets that
could have a material effect on the financial
statements.
|
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate. All internal control
systems, no matter how well designed, have inherent
limitations. Therefore, even those systems determined to be effective
can provide only reasonable assurance with respect to financial statement
preparation and presentation. Because of the inherent limitations of
internal control, there is a risk that material misstatements may not be
prevented or detected on a timely basis by internal control over financial
reporting. However, these inherent limitations are known features of
the financial reporting process. Therefore, it is possible to design into the
process safeguards to reduce, though not eliminate, this risk.
As of
December 31, 2009 management assessed the effectiveness of our internal control
over financial reporting based on the criteria for effective internal control
over financial reporting established in Internal Control—Integrated Framework
issued by the Committee of Sponsoring Organizations of the Treadway Commission
(“COSO”) and SEC guidance on conducting
such assessments. Based on that
evaluation, they concluded that, during the period covered by this
report, such internal controls and procedures were not
effective to detect the inappropriate application of US GAAP rules as more fully
described below. This was due to deficiencies that existed in the
design or operation of our internal controls over financial reporting that
adversely affected our internal controls and that may be considered to be
material weaknesses.
The
matters involving internal controls and procedures that our management
considered to be material weaknesses under the standards of the Public Company
Accounting Oversight Board were the lack of a functioning audit committee due to
a lack of a majority of independent members and a lack of a majority of outside
directors on our board of directors, resulting in ineffective oversight in the
establishment and monitoring of required internal controls and
procedures. This material weakness was identified by our Chief
Executive Officer in connection with the review of our financial statements as
of December 31, 2009.
Management
believes that the lack of a functioning audit committee and the lack of a
majority of outside directors on our board of directors results in
ineffective oversight in the establishment and monitoring of required internal
controls and procedures, which could result in a material misstatement in our
financial statements in future periods.
24
This
annual report does not include an attestation report of the Company's registered
public accounting firm regarding internal control over financial
reporting. Management's report was not subject to
attestation by the Company's registered public accounting
firm pursuant to temporary rules of the SEC that permit the Company to provide
only the management's report in this annual report.
MANAGEMENT'S
REMEDIATION INITIATIVES
In an
effort to remediate the identified material weaknesses and other deficiencies
and enhance our internal controls, we have appointed an outside director to our
board of directors on March 29, 2010, who shall be appointed to a fully
functioning audit committee who will undertake the oversight in the
establishment and monitoring of required internal controls and procedures such
as reviewing and approving estimates and assumptions made by
management.
Management
believes that the appointment of an outside director, who shall be appointed to
a fully functioning audit committee, will remedy the lack of a functioning audit
committee and a lack of a majority of outside directors on our
Board.
Changes
in Internal Controls Over Financial Reporting
There was
no change in the Company’s internal control over financial reporting that
occurred during the Company’s last fiscal quarter that has materially affected,
or is reasonably likely to materially affect, its internal control over
financial reporting.
Item
9B. Other Information
None
25
PART
III
Item
10. Directors, Executive Officers and Corporate
Governance
The
following table sets forth information concerning our current executive officers
and directors:
Name
|
Age
|
Position
|
||
Robert
Brooke
|
29
|
President,
Chief Executive Officer, and Director
|
||
Richard
McKilligan
|
46
|
Secretary,
Treasurer, Chief Financial Officer, and Director
|
||
Mark
J. Ahn, PhD.
|
47
|
Director
|
ROBERT
BROOKE was appointed as our President and Chief Executive Officer, and also as a
Director, on March 15, 2010. Mr. Brooke is the founder and President
of Percipio Biosciences, Inc., a research diagnostics company that
manufactures and distributes world-wide products related to oxidative
stress research. From 2004 to 2008, he was an analyst with Bristol Capital
Advisors, LLC, investment manager to Bristol Investment Fund, Ltd. During
this period, Bristol financed over 60 public healthcare and life science
companies and was listed by The PIPEs Report as the most active investor in
private placements by public biotechnology companies. He currently is a
member of the Los Angeles Gerontology Research Group. Mr. Brooke earned a
B.S. in Electrical Engineering from Georgia Tech in 2003 and a M.S. in
Biomedical Engineering from UCLA in 2005.
RICHARD
MCKILLIGAN was appointed as our Secretary, Treasurer and Chief
Financial Officer, and also as a Director, on March 15, 2010. Mr.
McKilligan is a director of Bristol Investment Fund, Ltd., which holds a
significant equity stake in the Company. He is also Chief Financial Officer
and General Counsel of Derycz Scientific, Inc., a publicly traded company
engaged in providing published content to its customers for marketing,
regulatory or research purposes. Mr. McKilligan was an associate with Morgan,
Lewis & Bockius, LLP in their New York and London offices from 2000
until January 2006. He is a member of the State Bar of California, the New
York State Bar Association and The Florida Bar. Mr. McKilligan earned his
law degree from Cornell Law School, his MBA from the University
of Chicago and his undergraduate degree in Accountancy from the University
of Illinois at Urbana-Champaign.
MARK J.
AHN, Ph.D. is Associate Professor, Global Management at Atkinson Graduate School
of Management, Willamette University; and Principal at Pukana Partners, Ltd.
which provides strategic consulting to life science companies. He
previously served as Chair, Science & Technology Management, Victoria
University at Wellington, New Zealand. Dr. Ahn was also founder, President, and
Chief Executive Officer of Hana Biosciences. Prior to Hana, he served
as Vice President, Hematology and corporate officer at Genentech, Inc., as well
as held positions of increasing responsibility at Amgen and Bristol-Myers Squibb
Company. Dr. Ahn also serves on public and venture capital-backed Board of
Directors for RXi Pharmaceuticals, Access Pharmaceuticals, Periocyte, and
Mesynthes.
The
resignations of two of our former directors, Ibrahim Abotaleb and Gerald Lewis,
became effective on March 29, 2010, ten days after the filing with the SEC and
mailing to our stockholders of our Information Statement filed pursuant to Rule
14f-1 of the Exchange Act.
There are
no family relationships among any of our directors, executive officers or key
employees.
COMPLIANCE
WITH SECTION 16(A) OF THE EXCHANGE ACT
Section
16(a) of the Exchange Act requires our officers, directors, and persons who own
more than 10% of a registered class of our equity securities to file reports of
ownership and changes in ownership with the SEC. Officers, directors, and
greater than 10% beneficial owners are required by SEC regulation to furnish the
Company with copies of all Section 16(a) forms they file. Based solely on our
review of copies of the Section 16(a) reports filed for the fiscal year ended
December 31, 2009, we believe that all filing requirements applicable to our
officers, directors, and greater than 10% beneficial owners have been complied
with.
26
Code of
Ethics
We have
not yet adopted a written code of ethics that applies to our Chief Executive
Officer, Chief Financial Officer, principal accounting officer or persons
performing similar functions. We currently are considering the terms of such a
code and expect to adopt a code of ethics during the current fiscal
year.
COMMITTEES
OF THE BOARD OF DIRECTORS
We do not
have standing audit, nominating or compensation committees of the board of
directors, or committees performing similar functions, and therefore our
entire board of directors performs such functions. We are not
currently listed on any national exchange and are not required to maintain
such committees by any self-regulatory agency. We do not believe it is
necessary for our board of directors to appoint such committees because the
volume of matters that come before our board of directors for consideration
permits each director to give sufficient time and attention to such matters
to be involved in all decision making. All directors participate in
the consideration of director nominees. We do not have a policy with regard
to attendance at board meetings.
We do not
have a policy with regard to consideration of nominations of directors. We
accept nominations for directors from our security holders. There is no
minimum qualification for a nominee to be considered by our directors.
All of our directors will consider any nomination and will consider such
nomination in accordance with his or her fiduciary responsibility to the
Company and its stockholders.
Security
holders may send communications to our board of directors by writing
to Genesis Biopharma, Inc., 1601 N. Sepulveda Blvd., #632, Manhattan
Beach, California 90266, attention Board of Directors or any specified
director. Any correspondence received at the foregoing address to the
attention of one or more directors is promptly forwarded to such director
or directors.
Item
11. Executive Compensation
In prior
fiscal years, we have not compensated our directors for their service
as members of our board of directors. On March 30, 2010, however, we
granted an option to acquire 375,000 shares of our common stock to Mr. Mark J.
Ahn, who joined us as a director of the Company on March 29, 2010. We
do reimburse our directors for reasonable expenses in connection with
attendance at board meetings. From inception to date, we have not paid
compensation to our executive officers. The Company intends to enter into
definitive employment agreements with Mr. Brooke and Mr. McKilligan, which
agreements will provide for compensation commensurate with their
responsibilities as executive officers of the Company.
Item
12. Security Ownership of Certain Beneficial Owners and Management
and Related Stockholder Matters
The
following table sets forth certain information regarding the shares
of common stock beneficially owned or deemed to be beneficially owned as of
March 29, 2010 by: (i) each person whom we know beneficially owns more than 5%
of our common stock, (ii) each of our directors, (iii) each of our “named
executive officers” (as defined in Item 402(m)(2) of Regulation S-K), and (iv)
all such directors and executive officers as a group.
Except as
indicated by the footnotes below, we believe, based on the
information furnished to us, that the persons and entities named in the
table below have sole voting and investment power with respect to all
shares of our common stock that they beneficially own, subject to
applicable community property laws.
In
computing the number of shares of common stock beneficially owned by a
person and the percentage ownership of that person, pursuant to the rules
prescribed by the Securities and Exchange Commission we deem outstanding
shares of common stock subject to options or warrants held by that person
that are currently exercisable or exercisable within sixty (60) days of
March 29, 2010 and we do not deem these shares outstanding for the purpose
of computing the percentage ownership of any other person.
27
Name
|
Shares
of Common Stock
Beneficially Owned (1)
|
Percent
of Common Stock
Beneficially Owned (1)
|
||||||
5% or greater owners:
|
||||||||
Hamilton Atlantic
(2)
|
20,960,016 | 29.2 | % | |||||
Theorem
Group, LLC (3)
|
6,400,008 | 8.9 | % | |||||
Directors and executive
officers:
|
||||||||
Robert
Brooke
|
5,940,008 | 8.3 | % | |||||
Richard
McKilligan
|
2,720,016 | 3.8 | % | |||||
Mark
J. Ahn (4)
|
0 | 0 | ||||||
Ibrahim
Abataleb (5)
|
0 | 0 | ||||||
All
directors and executive officers as
a group (4 persons):
|
8,660,024 | 12.1 | % |
(1)
|
Applicable
percentage ownership is based on 71,860,008 shares (post-split) of
common stock outstanding at March 29, 2010. The number of shares
of common stock owned are those “beneficially owned” as determined
under the rules of the Securities and Exchange Commission, including
any shares of common stock as to which a person has sole or shared
voting or investment power and any shares of common stock which the person
has the right to acquire within sixty (60) days through the exercise of
any option, warrant or right.
|
(2)
|
Amy
Wang and Graham May exercise dispositive and voting control
with respect to the shares held by Hamilton
Atlantic.
|
(3)
|
Anshuman
Dube exercises dispositive and voting control with respect to
the shares held by Theorem
Group.
|
(4)
|
On
March 30, 2010, the Company granted Mr. Ahn options to purchase 375,000
common shares which vest over three years. As none of the
shares underlying such options may be acquired by Mr. Ahn within sixty
(60) days of March 29, 2010, we have not included any of such shares in
the table above.
|
(5)
|
Mr.
Abataleb is listed above as he is a “named executive officer” due to his
having been the Company’s principal executive officer in 2009. Mr.
Abataleb currently is not an officer or director of the Company, having
resigned as President and Chief Executive Officer on March 15, 2010 and as
a director effective March 29,
2010.
|
Item
13. Certain Relationships and Related Transactions, and Director
Independence.
Certain
Relationships and Related Transactions
In
connection with the Company’s acquisition of the assets pursuant to
the Purchase Agreement from Hamilton, and after the related 24-for-1
forward stock split and the related merger of our wholly owned subsidiary,
Mr. Brooke acquired beneficial ownership of 9,940,008 shares (post-split)
of our common stock held by Mr. Abotaleb at a purchase price of $2,070.84
and Mr. McKilligan acquired beneficial ownership of 2,720,016 shares
(post-split) of our common stock held by Mr. Abotaleb at a purchase price of
$566.67. The balance of the shares held by Mr. Abotaleb and all of the
shares held by Mr. Lewis, totaling an aggregate of 83,339,976 (post-split),
were then returned to the Company for cancellation and are no longer
outstanding.
Richard
McKilligan is a director of Bristol Investment Fund, Ltd., which is one of
the investors in our recently completed private placement and a
current stockholder of the Company.
Director
Independence
Mr. Ahn
is an independent director as that term is defined by NYSE Rule 303A.02(a). The
Company currently does not have a nominating/corporate governance, compensation
or audit committee. Of the members of the Company’s board of directors, Mr. Ahn
does meet the NYSE’s independence standards for members of such committees and
Mr. Brooke and Mr. McKilligan do not meet the NYSE’s independence requirements
for members of such committees.
28
Item
14. Principal Accounting Fees and Services.
Summary
of Principal Accounting Fees for Professional Services Rendered
The
following table presents the aggregate fees for professional audit services and
other services rendered by Seale & Beers, our independent registered public
accountants in the fiscal years ended December 31, 2009 and
2008.
|
Year Ended
December
31, 2009
|
Year Ended
December
31, 2008
|
||||||
Audit
Fees
|
$
|
5,260
|
6,050
|
|||||
Audit-Related
Fees
|
-
|
-
|
||||||
Tax
Fees
|
-
|
-
|
||||||
All
Other Fees
|
-
|
-
|
||||||
$
|
5,260
|
6,050
|
Audit Fees consist of fees
billed for the annual audit of our financial statements and other audit services
including the provision of consents and the review of documents filed with the
SEC.
We do not
have an independent audit committee and the full Board of Directors, therefore,
serves as the audit committee for all purposes relating to communication with
our auditors and responsibility for our audit. Our Board of Directors has
considered whether the provision of the services described above for the fiscal
years ended December 31, 2008 and 2009, is compatible with maintaining the
auditor’s independence.
All audit
and non-audit services that may be provided by our principal accountant to us
shall require pre-approval by the Board of Directors. Further, our auditor shall
not provide those services to us specifically prohibited by the SEC, including
bookkeeping or other services related to the accounting records or financial
statements of the audit client; financial information systems design and
implementation; appraisal or valuation services, fairness opinion, or
contribution-in-kind reports; actuarial services; internal audit outsourcing
services; management functions; human resources; broker-dealer, investment
adviser, or investment banking services; legal services and expert services
unrelated to the audit; and any other service that the Public Company Accounting
Oversight Board determines, by regulation, is impermissible.
29
PART
IV
Item
15. Exhibits, Financial Statements Schedules.
(a)
Documents filed as a part of this report
(1) Financial
Statements
The financial statements of
Genesis Biopharma, Inc. are incorporated by reference to Item 8 of this
report.
(2) Financial Statement
Schedules
Not
required for smaller reporting companies.
(b)
Exhibits
3.1
|
Articles
of Incorporation filed with the Nevada Secretary of State on September 17,
2007(1)
|
3.2
|
Certificate
of Change filed with the Nevada Secretary of State on March 15, 2010(2)
|
3.3
|
Articles
of Merger filed with the Nevada Secretary of State on March 15, 2010(3)
|
4.1
|
Genesis
Biopharma, Inc. 2010 Equity Compensation Plan*
|
10.1
|
Agreement
and Plan of Merger between Freight Management Corp. (renamed Genesis
Biopharma, Inc.) and Genesis Biopharma, Inc. dated March 15, 2010(4)
|
10.2
|
Asset
Purchase Agreement among Freight Management Corp. (renamed Genesis
Biopharma, Inc.), Genesis Biopharma, Inc., Hamilton Atlantic and the other
signatories thereto dated March 15, 2010(5)
|
10.3
|
Patent
and Know How Licence between Cancer Research Technology Limited and
Genesis Biopharma, Inc. (formerly Freight Management Corp.) dated March
15, 2010(6)
|
10.4
|
Form
of Private Placement Subscription Agreement(7)
|
10.5
|
Form
of Stock Option Agreement under Genesis Biopharma, Inc. 2010 Equity
Compensation Plan*
|
16.1
|
Letter
from former accountant - Moore & Associates Chartered(8)
|
16.2
|
Letter
from former accountant - Seale and Beers, CPAs(9)
|
31.1
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Executive
Officer*
|
31.2
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Financial
Officer*
|
32.1
|
Section
1350 Certification of Chief Executive Officer*
|
32.2
|
Section
1350 Certification of Chief Financial
Officer*
|
*
Filed herewith
(1)
|
Incorporated
by reference to Exhibit 3.1 to the Issuer’s Registration Statement on Form
SB-2 filed on January 29, 2008.
|
(2)
|
Incorporated
by reference to Exhibit 3(i).2 to the Issuer’s Current Report on Form 8-K
filed on March 19, 2010.
|
(3)
|
Incorporated
by reference to Exhibit 3(i).3 to the Issuer’s Current Report on Form 8-K
filed on March 19, 2010.
|
(4)
|
Incorporated
by reference to Exhibit 10.1 to the Issuer’s Current Report on Form 8-K
filed on March 19, 2010.
|
(5)
|
Incorporated
by reference to Exhibit 10.2 to the Issuer’s Current Report on Form 8-K
filed on March 19, 2010.
|
(6)
|
Incorporated
by reference to Exhibit 10.3 to the Issuer’s Current Report on Form 8-K
filed on March 19, 2010.
|
(7)
|
Incorporated
by reference to Exhibit 10.4 to the Issuer’s Current Report on Form 8-K
filed on March 19, 2010.
|
(8)
|
Incorporated
by reference to Exhibit 16.1 to the Issuer’s Current Report on Form 8-K/A
filed on August 25, 2009.
|
(9)
|
Incorporated
by reference to Exhibit 16.1 to the Issuer’s Current Report on Form 8-K
filed on March 8, 2010.
|
30
SIGNATURES
Pursuant to the requirements of Section
13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
GENESIS
BIOPHARMA, INC.
|
|||
By:
|
/s/
Robert T. Brooke
|
||
Robert
T. Brooke
|
|||
Date:
March 31, 2010
|
Chief
Executive Officer
|
||
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the registrant and in the
capacities and on the dates indicated.
Signature
|
Title
|
Date
|
||
/s/ Robert T.
Brooke
|
President and Chief Executive Officer | March 31, 2010 | ||
Robert
T. Brooke
|
(Principal
Executive Officer) and Director
|
|
||
/s/ Richard McKilligan | Chief Financial Officer | March 31, 2010 | ||
Richard
McKilligan
|
(Principal
Financial and Accounting Officer),
|
|
||
Treasurer, Secretary and Director |
31
EXHIBIT
INDEX
3.1
|
Articles
of Incorporation filed with the Nevada Secretary of State on September 17,
2007(1)
|
3.2
|
Certificate
of Change filed with the Nevada Secretary of State on March 15, 2010(2)
|
3.3
|
Articles
of Merger filed with the Nevada Secretary of State on March 15, 2010(3)
|
4.1
|
Genesis
Biopharma, Inc. 2010 Equity Compensation Plan*
|
10.1
|
Agreement
and Plan of Merger between Freight Management Corp. (renamed Genesis
Biopharma, Inc.) and Genesis Biopharma, Inc. dated March 15, 2010(4)
|
10.2
|
Asset
Purchase Agreement among Freight Management Corp. (renamed Genesis
Biopharma, Inc.), Genesis Biopharma, Inc., Hamilton Atlantic and the other
signatories thereto dated March 15, 2010(5)
|
10.3
|
Patent
and Know How Licence between Cancer Research Technology Limited and
Genesis Biopharma, Inc. (formerly Freight Management Corp.) dated March
15, 2010(6)
|
10.4
|
Form
of Private Placement Subscription Agreement(7)
|
10.5
|
Form
of Stock Option Agreement under Genesis Biopharma, Inc. 2010 Equity
Compensation Plan*
|
16.1
|
Letter
from former accountant - Moore & Associates Chartered(8)
|
16.2
|
Letter
from former accountant - Seale and Beers, CPAs(9)
|
31.1
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Executive
Officer*
|
31.2
|
Rule
13a-14(a)/15d-14(a) Certification of Chief Financial
Officer*
|
32.1
|
Section
1350 Certification of Chief Executive Officer*
|
32.2
|
Section
1350 Certification of Chief Financial
Officer*
|
(1)
|
Incorporated
by reference to Exhibit 3.1 to the Issuer’s Registration Statement on Form
SB-2 filed on January 29, 2008.
|
(2)
|
Incorporated
by reference to Exhibit 3(i).2 to the Issuer’s Current Report on Form 8-K
filed on March 19, 2010.
|
(3)
|
Incorporated
by reference to Exhibit 3(i).3 to the Issuer’s Current Report on Form 8-K
filed on March 19, 2010.
|
(4)
|
Incorporated
by reference to Exhibit 10.1 to the Issuer’s Current Report on Form 8-K
filed on March 19, 2010.
|
(5)
|
Incorporated
by reference to Exhibit 10.2 to the Issuer’s Current Report on Form 8-K
filed on March 19, 2010.
|
(6)
|
Incorporated
by reference to Exhibit 10.3 to the Issuer’s Current Report on Form 8-K
filed on March 19, 2010.
|
(7)
|
Incorporated
by reference to Exhibit 10.4 to the Issuer’s Current Report on Form 8-K
filed on March 19, 2010.
|
(8)
|
Incorporated
by reference to Exhibit 16.1 to the Issuer’s Current Report on Form 8-K/A
filed on August 25, 2009.
|
(9)
|
Incorporated
by reference to Exhibit 16.1 to the Issuer’s Current Report on Form 8-K
filed on March 8, 2010.
|
32