8-K/A
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K/A
(Amendment No. 1)
CURRENT
REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): September 21, 2009
QuikByte Software, Inc.
(Exact Name of Registrant as Specified in Its Charter)
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Colorado
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000-52228
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33-0344842 |
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(State or Other
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(Commission File
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(IRS Employer |
Jurisdiction of
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Number)
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Identification No.) |
Incorporation) |
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6042 Cornerstone Ct. West, Suite B
San Diego, CA 92121
(Address of principal executive offices, including zip code)
(858) 205-4193
(Registrants telephone number, including area code)
4400 Biscayne Boulevard, Suite 950
Miami, Florida 33137
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing
obligation of the registrant under any of the following provisions (see General Instruction A.2.
below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Explanatory Note
QuikByte Software, Inc. is filing this Amendment No. 1 to its Current Report on Form 8-K,
originally filed with the Securities and Exchange Commission on September 21, 2009 (the Original
Form 8-K), to disclose that QuikByte Software Inc.s acquisition of Sorrento Therapeutics, Inc., a
Delaware corporation, pursuant to that certain Merger Agreement, dated July 14, 2009, as amended,
by and among QuikByte Software Inc., Sorrento Therapeutics, Inc. and Sorrento Merger Corp., Inc., a
Delaware corporation and wholly-owned subsidiary of QuikByte Software Inc., Stephen Zaniboni, as
Stockholders Agent thereunder, and Glenn Halpryn, as Parent Representative thereunder, was
consummated on September 21, 2009. The Original Form 8-K incorrectly stated that the acquisition
was consummated on September 18, 2009. This Amendment No. 1 is also being filed to change the date from September 18, 2009 to September
21, 2009 in Exhibits 10.3 and 10.11 to the Original Form 8-K and to change the date from
September 18, 2010 to September 21, 2010 in Exhibit 10.11 to the Original Form 8-K.
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Item 1.01. |
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Entry into a Material Definitive Agreement. |
The disclosures set forth in Item 2.01 to this Current Report on Form 8-K are incorporated by
reference into this Item 1.01.
Item 2.01. Completion of Acquisition or Disposition of Assets.
On September 21, 2009 (the Closing Date), QuikByte Software, Inc., a Colorado corporation
(QuikByte, the Company or we, our or us), consummated its acquisition of Sorrento
Therapeutics, Inc., a Delaware corporation (STI), pursuant to that certain Merger Agreement,
dated July 14, 2009, as amended (referred to as the Merger Agreement), by and among the Company,
STI and Sorrento Merger Corp., Inc., a Delaware corporation and our wholly-owned subsidiary
(Merger Sub), Stephen Zaniboni, as Stockholders Agent thereunder (Stockholders Agent), and
Glenn Halpryn, as Parent Representative thereunder (Parent Representative). In accordance with
the Merger Agreement, Merger Sub merged with and into STI (the Merger), with STI as the surviving
corporation and as our wholly-owned subsidiary. At the closing of the Merger (the Merger
Closing), all of the issued and outstanding shares of STI common stock (the STI Shares) were
converted into the right to receive an aggregate of 169,375,807 shares of QuikByte common stock,
par value $0.0001 per share (the QuikByte Common Stock).
On
September 18, 2009, as a condition to the Merger Closing, QuikByte entered into a Stock
Purchase Agreement (the Stock Purchase Agreement) with the investors listed on Exhibit A thereto
(the Investors) pursuant to which QuikByte received an aggregate investment of $2.0 million in
consideration for an aggregate of 44,634,374 shares of QuikByte Common Stock (the Financing). The
Investors included affiliates of Dr. Phillip Frost, Chairman and Chief Executive Officer of OPKO
Health, Inc. (OPKO), which was a 34.8% stockholder of STI prior to the Merger, an entity in which
Mr. Glenn Halpryn, a director of the Company and its former Chairman, President and Chief Executive
Officer, and Mr. Steven Jerry Glauser, a greater than 5% shareholder of the Company, are members,
Mr. Noah Silver, a former director and Vice President, Secretary and Treasurer of the Company, and
Mr. Ronald Stein, a former director of the Company. Proceeds from the Financing are expected to be
used to fund the Companys general working capital and post-Merger research and development
activities.
Upon completion of the Merger, after giving effect to the Financing, the QuikByte shareholders
as of immediately prior to the Financing owned approximately 4.92% of the Company, the Investors,
some of whom were QuikByte shareholders as of immediately prior to the Financing, owned
approximately 19.83% of the Company, not including the shares of QuikByte they owned immediately
prior to the Financing, and the former holders of STI Shares (including OPKO) owned approximately
75.25% of the Company, in each case on a fully-diluted basis.
Additionally, pursuant to the Merger Agreement, upon consummation of the Merger the board of
directors of the Company was expanded from five to seven members, all prior QuikByte directors
except for Mr. Glenn Halpryn and Dr. Curtis Lockshin resigned, and the following new directors were
appointed: Drs. S. James Freedman, Henry Ji, Antonius Schuh and Ernst-Güenter Afting and
Mr. Lewis Shuster. Each of the new directors will hold office until the earlier of
the next annual meeting of shareholders and the election and qualification of their successors
or their earlier death, resignation or removal. Additionally, effective upon consummation of the
Merger, Glenn L. Halpryn resigned as Chief Executive Officer and President and Noah Silver resigned
as Vice President, Secretary and Treasurer, and our board of directors appointed the following
persons to serve in the offices set forth across from their names:
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Dr. Antonius Schuh
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Chief Executive Officer |
Dr. Henry Ji
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Chief Scientific Officer and Secretary |
Also pursuant to the Merger Agreement, the holders of 66.2% of the shares of QuikByte Common
Stock as of prior to the Financing, prior holders of 100% of the STI Shares and the holders of 100%
of the shares of QuikByte Common Stock acquired by the Investors in the Financing entered into
lock-up agreements in respect of each such persons or entities shares of QuikByte Common Stock.
The lock-up agreements provide that such shares
may not be sold, directly or indirectly, for a
period of 24 months following consummation of the Merger, subject to certain exceptions.
The QuikByte Common Stock issued under the Merger Agreement to the holders of STI Shares, and
the shares sold to the Investors in the Financing, were not registered under the Securities Act of
1933, as amended (the Securities Act), or any state securities laws, in reliance upon the
exemption from registration provided by Section 4(2) of the Securities Act and Regulation D
promulgated under that section, which exempts transactions by an issuer not involving a public
offering. None of these securities may be offered or sold in the United States absent registration
or an applicable exemption from the registration requirements. No registration rights have been
granted to the prior holders of STI Shares or any other party.
The consolidation effected by the Merger will be accounted for as a reverse acquisition
wherein STI will be treated as the acquirer for accounting purposes since it will control the
combined enterprise.
Subsequent to the Merger and subject to approval by our shareholders, we intend to change our
name to Sorrento Therapeutics, Inc. and redomesticate or reincorporate from a corporation
organized and existing under the laws of the State of Colorado to a corporation organized and
existing under the laws of the State of Delaware. Former holders of STI Shares which now represent
more than 50% of the outstanding shares of QuikByte Common Stock have agreed to vote in favor of
the preceding matters if a vote to approve them is held within three months of the Closing Date;
among such holders are Drs. Schuh and Ji, Mr. Zaniboni and OPKO. Our common stock is traded on the
OTC Bulletin Board (OTCBB) under the symbol QBSW.
FORM 10 DISCLOSURES
As disclosed elsewhere in this Current Report on Form 8-K, on September 21, 2009, we acquired
STI upon consummation of the Merger. Item 2.01(f) of Form 8-K provides that if a registrant was a
shell company, as such term is defined in Rule 12b-2 under the Securities
Exchange Act of 1934, as amended (the Exchange Act), as we were immediately preceding the
Merger, then the registrant must disclose the information that would be required if the registrant
were filing a general form for registration of securities on Form 10 under the Exchange Act (Form
10).
Accordingly, set forth below is the information that would be included in Form 10. Please note
that the information provided below relates to the combined company subsequent to the Merger,
except that information relating to periods before the Closing Date relates only to QuikByte,
unless otherwise specifically indicated.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Current Report on Form 8-K, including the Form 10 disclosures, contain forward-looking
statements, as that term is defined under the Private Securities Litigation Reform Act of 1995
(the PSLRA). Forward-looking statements include statements about our expectations, beliefs or
intentions regarding our product offerings, business, financial condition, results of operations,
strategies or prospects. You can identify forward-looking statements by the fact that these
statements do not relate strictly to historical or current matters. Rather, forward-looking
statements relate to anticipated or expected events, activities, trends or results as of the date
they are made. Because forward-looking statements relate to matters that have not yet occurred,
these statements are inherently subject to risks and uncertainties that could cause our actual
results to differ materially from any future results expressed or implied by the forward-looking
statements. Many factors could cause our actual activities or results to differ materially from the
activities and results anticipated in forward-looking statements. These factors include those
described under the caption Risk Factors in Item 1A of these Form 10 disclosures, some of which
are briefly listed below. We do not undertake any obligation to update forward-looking statements.
We intend that all forward-looking statements be subject to the safe-harbor provisions of the
PSLRA. These forward-looking statements are only predictions and reflect our views as of the date
they are made with respect to future events and financial performance. We undertake no obligation
to update, and we do not have a policy of updating or revising, these forward-looking statements.
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Risks and uncertainties, the occurrence of which could adversely affect our business, are set
forth in the section entitled Risk Factors below.
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Except where the context otherwise requires, the terms, we, us, our or QuikByte refer
to the business of QuikByte Software, Inc. and its consolidated subsidiary, STI. STI refers to
the business of Sorrento Therapeutics, Inc., our wholly-owned subsidiary. STI is our sole operating
subsidiary and comprises all of our operations as of the date of this Current Report on Form 8-K.
The following description of our business should be read in conjunction with the information
included elsewhere in this Current Report on Form 8-K. The description contains certain
forward-looking statements that involve risks and uncertainties. When used in this
Current Report on Form 8-K, the words intend, anticipate, believe, estimate, plan
and expect and similar expressions as they relate to us are included to identify forward-looking
statements. Our actual results could differ materially from the results discussed in the
forward-looking statements as a result of certain of the risk factors discussed below, and those
described under Risk Factors in this Current Report on Form 8-K.
Sorrento Therapeutics, Inc.
We are a development-stage biopharmaceutical company focused on applying our proprietary
technology platform for the discovery and development of human therapeutic antibodies for the
treatment of a variety of disease conditions, including cancer, inflammation, metabolic disease and
infectious disease. We believe that our proprietary technology (the STI Technology) will allow us
to construct an antibody library containing fully human antibodies. This library will be designed
to facilitate the rapid identification and isolation of highly specific, antibody therapeutic
product candidates that are fully human and that bind to disease targets appropriate for antibody
therapy.
Our objective is to construct a human antibody library and, either independently or through
one or more partnerships with pharmaceutical or biopharmaceutical organizations, to identify drug
development candidates derived from this library. We intend to focus our initial efforts toward
using our proprietary technology to create a fully human antibody library that will be the basis
for our subsequent development. Following the construction of our library, we plan to focus our
efforts primarily in the identification and isolation of human antibody drug candidates. In the
event we are successful in developing our antibody library and any product candidates, we intend to
actively seek partners with experience and expertise in the antibody drug development field in
order to engage in any clinical development of these candidates. In the event we are able to
construct a fully human antibody library, our objective is to generate revenue through service
fees, technology access fees and license fees by offering access to the library and any development
candidates derived from the library.
STI was originally incorporated as San Diego Antibody Company in California in 2006 and was
renamed Sorrento Therapeutics, Inc. and reincorporated in Delaware in 2009. QuikByte was originally
incorporated in Colorado in 1989. On July 14, 2009, STI, QuikByte, Merger Sub, Stockholders Agent
and Parent Representative entered into the Merger Agreement. Pursuant to the Merger, which was
consummated on September 21, 2009, Merger Sub merged with and into STI, the separate corporate
existence of Merger Sub terminated and STI became a wholly-owned subsidiary of QuikByte. Subject to
approval by QuikBytes shareholders, QuikByte intends to change its name to Sorrento Therapeutics,
Inc. and redomesticate from a corporation organized and existing under the laws of the State of
Colorado to a corporation organized and existing under the laws of the State of Delaware. Former
holders of STI Shares which now represent more than 50% of the outstanding shares of QuikByte
Common Stock have agreed to vote in favor of the preceding matters if a vote to approve them is
held within three months of the Closing Date, or six months under certain circumstances. Among
these holders are Drs. Schuh and Ji, Mr. Zaniboni and OPKO.
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Our principal executive offices are located at 6042 Cornerstone Ct. West, Suite B, San Diego, CA 92121, and our telephone number at that address is (858) 205-4193. Our website is www.sorrentotherapeutics.com. The contents of our website are not part of this Current Report on Form 8-K.
Background to Antibodies
The Function of Antibodies
The human immune system protects the body against a variety of infections and other illnesses. Specialized cells work together with the other components of the immune system to recognize, neutralize and eliminate from the body numerous foreign substances, infectious organisms and malignant cells.
Antibodies are part of the bodys principal defense mechanism against disease-causing organisms and other foreign molecules and toxins. Antibodies are protein molecules that are capable of recognizing substances potentially harmful to the human body, known as antigens, and binding to those antigens to neutralize or block them from interacting with and causing damage to the
body. Antibodies are capable of recognizing and distinguishing between the subtlest of molecular differences in antigens. Antibodies that bind tightly to antigens are said to have high affinity.
Antibodies are naturally present in the blood and can survive in the circulation for extended periods in order to perform their surveillance and defense functions. Antibodies are made in the immune system by human white blood cells, called leukocytes. Human leukocytes produce millions of different types of antibodies, all with varying shapes that allow them to attach to and,
as a result, neutralize different disease targets. For example, certain antibodies seek out and attach to viruses, bacteria and diseased cells, making them susceptible for destruction by the human immune system. Others attach to specific disease targets and block their interaction with other molecules or can be used to deliver a toxic agent to directly kill cancer cells.
As depicted below, the basic structure of an antibody comprises four polypeptides of two different sizes, two identical light chains and two identical heavy chains, named according to their relative size. The heavy and light chains are assembled within the white blood cell to form an antibody molecule. Each chain has a variable region, which contains the binding site for an
antigen and gives the antibody its specificity, and a constant region which interacts with other parts of the immune system to facilitate the removal of the pathogen or foreign molecule. The genetic code determining the structure of a given variable region is referred to as immunoglobulin variable domain sequence.
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Different antibodies are produced, in part, through random recombination of genes for the
variable regions, as well as random pairing of the heavy and light chains. As a result, the immune
system is able to adapt and produce antibodies against virtually any antigen. When an antibody
encounters an antigen to which it binds, the white blood cell which produces the antibody
proliferates to generate more antibodies against the target antigen. White blood cells which have
differentiated to produce a specific antibody are called B lymphocytes.
Antibodies as Products
Recent advances in the technologies for creating and producing antibody products, coupled with
a better understanding of how antibodies and the immune system function in key disease states, have
led to significant interest in the commercial development of antibodies as therapeutic products.
Evidence of this commercial development is discussed in the following publications, among others:
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According to a January 2009 publicly-available abstract for a market report
titled Antibodies in Oncology: Drug Pipeline Update 2009, today there are more
than 222 companies plus partners developing more than 463 antibody based oncology
drugs in more than 820 developmental projects and, in total, these antibody based
drugs target around 64 different cancer indications. |
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A press release published in pipelinereview.com on November 25, 2008, states:
In 2007, total sales for the 20 antibody drugs on the market amounted to more than
US $25 billion and antibody sales are forecast to increase to approximately US $50
billion in 2013. Fully human antibodies are recognized as the next generation and
the majority of therapeutic antibodies currently in development are humanized or
fully human. The average industry timescale from discovery to pre-clinical
development of antibody therapies is only two to three years, considerably shorter
than the average six years for small molecules. Antibodies also incur lower
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A publicly-available summary of the report titled Monoclonal Antibody
Therapeutics, published by Bharat Book Bureau in August 2009, states: Monoclonal
antibodies achieved total sales of nearly $32bn in 2008 and have grown rapidly to
command over 30% of the global biologic drug market and that the authors of the
report expect significant opportunities for further commercial growth from 2009 to
2024.
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We believe that, as products, antibodies have several potential clinical and commercial
advantages over traditional therapies, including small molecule drugs and surgery. These advantages
may include the following:
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fewer unwanted and uncomfortable side effects as a result of high specificity
for the disease target; |
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greater patient compliance (use) as a result of more favorable pharmacokinetics
over traditional therapies, including better absorption, distribution, metabolism
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enhanced ability to deliver various payloads, including drugs, radiation and
toxins, to specific disease sites while avoiding surrounding (healthy) tissues. |
Monoclonal and Chimeric/Humanized Antibodies
The therapeutic antibodies marketed today generally belong to a class of molecules known as
monoclonal antibodies (mAbs). This term is used to refer to a homogeneous population of
antibody molecules that are identical in their structure and functional characteristics.
Historically, the approach to generating monoclonal antibodies has been to immortalize
antibody-producing white blood cells from mice, so that the cells are capable of reproducing over
an indefinite period of time. Any of these immortalized, fused cells, known as hybridomas and
producing a specific antibody with desired binding characteristics, can then be selected, cloned
and expanded, allowing the large scale production of a mouse mAb, or mouse antibody.
However, mouse antibodies are wholly composed of mouse protein sequences and tend to be
recognized as foreign by the human immune system. When patients are repeatedly treated with mouse
antibodies, they will begin to produce antibodies that effectively neutralize the mouse antibody, a
reaction referred to as a Human Anti-Mouse Antibody (HAMA) response. In many cases, the HAMA
response prevents the mouse antibodies from having the desired therapeutic effect and may cause the
patient to have an allergic reaction.
Recognizing the limitations of mouse mAbs, researchers have developed a number of approaches
to make them appear more human-like to a patients immune system. For example, improved forms of
mouse antibodies, referred to as chimeric and humanized antibodies, are genetically engineered
and assembled from portions of mouse and human antibody gene fragments. While these chimeric and
humanized antibodies are more human-like, they still retain a varying amount of the mouse antibody
protein sequence, and accordingly may continue to trigger a HAMA response. Additionally, the
chimeric/humanization process can be expensive and time-consuming, often requiring additional weeks
or months of secondary manipulation after the initial generation of the mouse mAbs.
Human Antibodies
The probability of inducing a HAMA response can be reduced through the generation of antibody
therapeutic products with fully human protein sequences. Researchers have developed several
antibody technologies to produce antibodies with 100% or fully human protein sequences. One
approach to generating human antibodies, known as antibody display technology, involves cloning
and expressing human antibody genes in novel contexts, such as bacteriophages, which are viruses
that infect bacteria, yeast or ribosome/mRNA complexes, in order to display libraries of antibody
fragments for subsequent in vitro selection against antigens. Ribosomes are intracellular
organelles that synthesize proteins. The information for the sequence of amino acids used to
synthesize a given protein comes from the mRNA sequence, which is read by the ribosome. A
ribosome/mRNA complex is mRNA attached to a ribosome for translation into a protein. The STI
Technology and the Winter II Technology discussed below are both antibody display technologies.
Another approach to develop human antibodies, called human mouse technology, is based on
genetically engineered strains of mice in which the attempt has been made to inactivate mouse
antibody gene expression and to functionally replace it with human antibody gene expression. The
so-called human mouse can be immunized with an antigen of interest, and if, after some time, which
is often many months, a sufficient immune response has taken place, human antibody candidates may
be obtained.
An additional approach involves the clonal isolation and expansion of human B-lymphocytes.
This approach is generally limited to creating antibodies only to non-human antigens or antigens to
which the lymphocyte donor had previously responded. Accordingly, it may not be suitable for
targeting many key diseases, such as cancer and inflammatory and autoimmune disorders, for which appropriate therapy might require antibodies
to human antigens.
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Technology
Overview - Proprietary Human Antibody Library Technology
Winter II Technology
An industry-leading technology for the construction of human antibody libraries is the
so-called Winter II Technology, which was developed by the Medical Research Council (MRC) at
Cambridge, UK, The Scripps Research Institute in La Jolla, CA, and Stratagene, Inc. in La Jolla,
CA. The Winter II Technology was licensed in part to Cambridge Antibody Technology Group (CAT),
which is now owned by AstraZeneca PLC, and in part to Domantis Ltd., which is now owned by Glaxo
SmithKline PLC. Through a settlement of an intellectual property dispute with CAT, MorphoSys AG
practices a variation of the Winter II Technology in constructing its antibody library. The Winter
II Technology process applies certain established gene sequence amplification technologies, such as
polymerase chain reaction (PCR), to construct human antibody libraries. Gene sequence
amplification is a process that produces a large number of copies of a given nucleic acid sequence
or a group of nucleic acid sequences, which are the sequences in molecules that carry genetic
information or form structures within cells most commonly DNA and RNA. PCR is
sequence-dependent, which means it amplifies only one or more specific nucleic acid sequences,
depending on which primer is used. A primer is a specific synthetic starter sequence used in the
amplification process. Once a large number of copies of specific nucleic acid sequences are
produced by amplification, the copied nucleic acid sequences are transferred into a display system,
which can translate the nucleic acid sequence information into proteins. This translation is
referred to as protein expression. The expressed proteins can be used for subsequent in vitro
selection against antigens, or antibody targets. The Winter II Technology process is covered by
U.S. patents that begin to expire in 2018.
STI Technology
As opposed to the Winter II Technology, the STI Technology applies ribonucleic acid (RNA)
transcription. RNA transcription is the replication of one strand of DNA template into hundreds of
corresponding RNA sequences. Because it can be used with a single universal primer, RNA
transcription is not sequence-dependent. Therefore, it can produce a large number of copies from a
virtually unlimited variety of nucleic acid sequences and permits amplification of different gene
sequences in parallel. When used to amplify immunoglobulin variable domain sequences, RNA
transcription can amplify virtually the entire genetic information encoding for the variable
domains of human antibodies. These amplified variable domain sequences can then be cloned into an
appropriate expression system to produce a human antibody library.
While PCR was introduced in the mid 1980s, primarily for the purpose of amplifying specific
gene sequences, RNA transcription-based amplification has gained popularity since the mid-1990s,
primarily for the amplification of complex genetic sequence mixtures prior to micro-array analysis.
RNA transcription appears ideally suited for use in the construction of a fully human antibody
library because RNA transcription-based amplification is designed for amplifying a complex
population of gene sequences, including the numerous gene sequences coding for the variable domains
of human antibodies, in parallel.
We believe that the STI Technology will allow us to use RNA transcription-based amplification
to construct a fully human antibody library. This library should facilitate the rapid
identification and isolation of highly specific, antibody therapeutic product candidates that are
fully human and that bind to disease targets appropriate for antibody therapy. The STI Technology
was invented by Henry Ji, Ph.D., STIs scientific co-founder and our Chief Scientific Officer. A
U.S. patent covering the STI Technology was issued in July 2008.
Opportunity
The commercial and clinical success of antibody therapeutics and the general preference for
fully human antibodies has led to a recent industry consolidation, whereby a number of technology
providers of human antibody discovery platforms have been acquired by large pharmaceutical or
biopharmaceutical companies, or have entered into significant collaborative agreements with large
pharmaceutical companies, which, in effect, limit third parties access to their discovery
platforms. Specifically:
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In 2006, AstraZeneca PLC acquired 100% ownership of CAT; Amgen Inc. acquired
Abgenix, Inc.; and Glaxo SmithKline PLC entered into a large collaboration
agreement with Genmab AS. |
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In 2007, Glaxo SmithKline PLC acquired Domantis Ltd., Eisai Co. acquired
Morphotek, Inc. and Novartis AG entered into a large collaboration agreement with
MorphoSys AG. |
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In 2009, Bristol-Myers Squibb Co. announced an agreement to acquire Medarex,
Inc. |
We believe this industry consolidation has helped to create a market opportunity for a novel,
proprietary technology to create fully human antibodies.
Sorrento Therapeutics Strategy
Our objective is to develop a human antibody library and potentially become a leading partner
to the pharmaceutical and biopharmaceutical industry as a provider of (1) access to human antibody
libraries, and (2) human antibody drug development candidates derived from our libraries. Key
elements of our strategy to accomplish this objective include the following:
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Constructing a large, naïve-human antibody library for antibody product
development. Utilizing the STI Technology, we intend to construct a large, well
characterized human antibody library. Following construction, we plan to screen
clinically established antigens in the areas of infectious diseases, cancer,
cardiovascular, or autoimmune and inflammatory diseases against this library with
the goal to identify high affinity, functional antibodies. We believe these
antibodies will validate our library and represent potential proprietary drug
development candidates. The human antibodies so isolated for the antigens will be
subjected to further biochemical characterization and functional testing, such as
binding affinity, specificity and kinetics. The isolated human antibodies may
undergo further optimization, applying for example in vitro maturation or molecular
evolution to improve their affinity and specificity. We expect to gain access to
antigens through contractual arrangements with leading academic researchers and
companies involved in the identification and development of antigens or from
publicly available sources. |
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Constructing patient- or disease-specific human antibody libraries. We plan to
make our platform technology available to others and generate revenues by
selectively entering into contracts with pharmaceutical and biotechnology companies
interested in using the STI Technology to develop antibody-based products. |
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Among others, we plan to offer services where we construct human antibody libraries
from blood samples derived from patient populations proposed by our potential
collaboration partners, who may have an interest in the human immune response
observed in individuals suffering from a specific condition. |
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Establishing partnerships to seek development efficiency. We intend to minimize
technology risk and optimize development efficiency. For fast follower products,
the clinical development program established by the first-in-class provider is a
significant advantage, as it represents a development strategy that has been shown
to be successful. For first-in-class products, we expect to seek partnerships with
biopharmaceutical companies with experience and expertise in the clinical
indications under consideration for any drug candidates we develop. |
See the section entitled Risk Factors in this Current Report on Form 8-K for a discussion of
some of the risks relating to the execution of our business strategy.
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Competitive Analysis
Winter II
The Winter II Technology is an industry leading antibody display technology, which is applied
by CAT (now owned by AstraZeneca PLC), Domantis Ltd. (now owned by Glaxo SmithKline PLC) and
Morphosys AG (engaged in a large collaboration with Novartis AG). Winter II Technology is a process to generate
human antibody libraries via amplification of the highly variable regions of the heavy and light
chains of human immunoglobulin genes obtained from human blood samples, followed by cloning and
expression in a display system. The Winter II Technology is deemed to be the gold standard for the
construction of an antibody library.
Additional Competitors
An additional approach involves the clonal isolation and expansion of human B-lymphocytes.
This approach is generally limited to creating antibodies only to non-human antigens or antigens to
which the lymphocyte donor had previously responded. Accordingly, it may not be suitable for
targeting many key diseases, such as cancer and inflammatory and autoimmune disorders, for which
appropriate therapy might require antibodies to human antigens.
Another approach to develop human antibodies, called human mouse technology, is based on
genetically engineered strains of mice in which the attempt has been made to inactivate mouse
antibody gene expression and to functionally replace it with human antibody gene expression. The
so-called human mouse can be immunized with an antigen of interest, and if, after some time, which
is often many months, a sufficient immune response has taken place, human antibody candidates may
be obtained. Based on publicly-available information, other approaches to generating fully human
antibodies from mice that we believe are being pursued by our competitors include:
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Transgenic mice containing heavy human chain and human light chain genes on a
minilocus (which are mice that possess a relatively small number of
representative human heavy and light chain genes in their genome). |
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Transchromosomic mice that contain large numbers of human heavy chain and
light chain genes on one or more separate, or extra, chromosomes. |
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KM-Mouse® animals that are generated as a result of breeding minilocus
containing mice with transchromosomic mice. Transchromosomic mice were
developed by Kirin Brewing Co., Ltd. It is our understanding that KM-Mouse
animals were developed through collaboration between Medarex, Inc. and Kirin
Brewing Co. and are currently used by Medarex, Kirin and GenMab A/S. |
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We believe Avanir Pharmaceuticals and XTL Biopharmaceuticals Ltd. use
technologies in which human B cells and T cells are implanted in mice with
compromised immune systems. |
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BioSite Incorporated, through a collaboration with Medarex, generates human
antibody phage display libraries from immunized KM-Mouse animals. Based on a
review of publicly-available information, it is our understanding that these
libraries are not used for deriving therapeutic antibody products. |
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Morphotek, Inc., a subsidiary of Esai Co, applies its MORPHODOMA® and Libradoma
technologies for the generation of fully human antibodies. |
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AnaptysBio, Inc. applies certain components of somatic hypermutation to generate
therapeutic antibodies. |
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Adimab, Inc. applies a yeast based platform for the development of fully human
antibodires, which, it claims, provides results faster when compared to human
B-cell/hybridoma cell line based approaches. |
The biopharmaceutical space is characterized by intense competition and rapid technological
advances. Even if we are able to develop our proprietary platform technology and an antibody
library, each will compete with a number of existing and future technologies and product candidates
developed, manufactured and marketed by others. Specifically, we will compete against fully
integrated pharmaceutical companies and smaller companies that are collaborating with larger
pharmaceutical companies, academic institutions, government agencies and other public and private
research organizations. Many of these competitors have technologies already FDA-approved or in development. In addition, many of these competitors, either alone or together with their
collaborative partners, operate larger research and development programs and have substantially
greater financial resources than we do.
10
Our Technology Advantages
We believe the STI Technology may offer the following advantages over competing technologies:
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The STI Technology is being designed to provide the full spectrum of human
immunoglobulin gene recombination in fully human mAb libraries. Unlike chimeric and
humanization technologies, we believe the STI Technology will allow the generation
of antibodies with fully human protein sequences and will not be exposed to the
challenges and limitations of human-to-animal gene transfer procedures. |
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Because the STI Technology represents an in vitro human mAb library technology,
it enables fast and cost-effective in vitro screening of a large number of
antigens. The STI Technology is designed so that any antigen of interest can be
investigated, without dependence on the successful induction of a host immune
response against the antigen. As opposed to the human-mouse technology, the STI
Technology does not require the establishment and maintenance of large animal
husbandries, which are quite costly to establish and maintain. In addition, a given
human antigen may not induce an immune response in mice. In such cases, the
human-mouse technology appears to be less suitable for delivering human antibody
development candidates. |
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We believe the STI Technology will deliver fully human mAb libraries. Once
constructed, we believe these libraries will be stable and capable of being stored
for long-term use at minimal maintenance cost. |
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The STI Technology applies RNA transcription-based amplification, which is
linear and non-preferential, and should replicate and amplify the human
immunoglobulin gene pool more faithfully than other amplification technologies,
including Winter II Technology, potentially resulting in human antibody libraries
more accurately displaying the human immunoglobulin gene pool. |
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While PCR is ideally suited to amplify one specific nucleic acid sequence at a
time, RNA transcription supports amplifying large numbers of different nucleic acid
sequences in parallel. RNA transcription-based linear amplification allows very
large numbers of distinct nucleic acid sequences to be amplified in parallel.
Therefore, it eliminates certain problems experienced with PCR, including preferred
sequence specific amplification rates and amplification drop outs, which are
sequences that are not or only incompletely amplified. |
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The STI Technology can potentially produce multiple product candidates against
one or more antigens in a pathway of interest more quickly and cost effectively. |
In addition, we believe that the STI platform offers the following advantages over competing
platforms:
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We are an independent, development stage biotechnology company and, except for
our license agreement with OPKO Health, we are not a party to agreements that
restrict our right to enter into collaborative arrangements with third parties. By
comparison, access to the Winter II Technology is, due to tightly held intellectual
property rights in the United States and the aforementioned industry consolidation,
restricted for United States pharmaceutical and biopharmaceutical companies. |
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We believe that the STI Technology can be applied by us for the construction of
fully human antibody libraries without license costs pertaining to the Winter II
Technology intellectual property licenses. |
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Unlike the STI Technology, due to tightly held intellectual property rights in
the U.S. and the industry consolidation discussed above, access to the Winter II
Technology is heavily restricted in the U.S. |
Intellectual Property
The STI Technology is an antibody display technology which is independent from the Winter II
Technology and related intellectual property (Winter II IP), because the STI Technology applies
RNA transcription for the amplification of human immunoglobulin variable domain sequences as
opposed to PCR. The STI Technology was invented by Henry Ji, Ph.D., STIs scientific co-founder and
our Chief Scientific Officer, and assigned to us by Dr. Ji.
A U.S. patent protecting the STI Technology was issued to us by the U.S. Patent and Trademark
Office in July 2008. Proprietary protection for our products, processes and know-how is critical to
our business. We rely on patents, trade secrets and proprietary know-how to protect our
intellectual property rights. We plan to diligently prosecute and defend our patents and
proprietary technology.
License Agreement with OPKO Health, Inc.
In June 2009, we entered into a limited license agreement (the License Agreement) with OPKO
Health, Inc. (OPKO) pursuant to which we granted OPKO an exclusive, royalty-free, worldwide
license under all U.S. and foreign patents and patent applications owned or controlled by us or any
of our affiliates (the STI Patents) to (i) develop, manufacture, use, market, sell, offer to
sell, import and export certain products related to the development, manufacture, marketing and
sale of drugs for ophthalmological indications (the OPKO Field) and (ii) use and screen any
population of distinct molecules covered by any claim of the STI Patents or which is derived by use
of any process or method covered by any claim of the STI Patents to identify, select and
commercialize certain products within the OPKO Field. Subject to certain limitations, OPKO will
have the right to sublicense the foregoing rights granted under the License Agreement.
Additionally, pursuant to the License Agreement, OPKO has granted us an exclusive, royalty-free,
worldwide license to any patent or patent application owned or controlled by OPKO or any of its
affiliates (the OPKO Patents) to develop, use, make, market, sell and distribute certain products
in any field of use, other than the OPKO Field (the STI Field).
We have retained all rights in the STI Patents outside of the OPKO Field and we have agreed
not to practice the OPKO Patents or the STI Patents outside the STI Field. Unless otherwise
terminated in accordance with its terms, the License Agreement will expire upon the expiration of
the last to expire patent within the STI Patents and OPKO Patents on a country-by-country basis.
Clinical Development
If we are successful in developing a fully human antibody library, we intend to focus our
effort primarily in the identification and isolation of the human antibody drug candidates and
further characterize these antibody candidates in in vitro functional testing. Then, in light of
our limited financial resources, we intend to actively seek product development partners in the
biopharmaceuticals industry with experience and expertise in the antibody drug development field in
order to engage in the clinical development of any product candidates we may seek to develop.
Manufacturing, Marketing and Sales
We currently do not have any manufacturing or sales capaibilities. We may or may not
manufacture the products we develop, if any. We intend to license to, or enter into strategic
alliances with, larger companies in the biopharmaceutical businesses, which are equipped to
manufacture, market and/or sell our products, if any, through their well-developed manufacturing
capabilities and distribution networks. We intend to license some or all of our worldwide patent
rights to more than one third party to achieve the fullest development, marketing and distribution
of any products we develop.
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Government Regulation
We are in the early stages of developing our antibody libraries and we have not yet developed
any product candidate. The U.S. Food and Drug Administration (FDA) regulates, among other things,
the development, testing, manufacture, safety, efficacy, record-keeping, labeling, storage,
approval, advertising, promotion, sale and distribution of biopharmaceutical products.
Specifically, government authorities in the U.S., at the federal, state, and local level, and
foreign countries extensively regulate, among other things, the following areas relating to
products and product candidates labeled for use in humans:
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research and development; |
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testing, manufacture, labeling and distribution; |
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advertising, promotion, sampling and marketing; and |
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import and export. |
In particular, human therapeutic products are subject to rigorous preclinical and clinical
trials to demonstrate safety and efficacy and other approval procedures of the FDA and similar
regulatory authorities in foreign countries. Clinical trial programs in humans generally follow a
three-phase process. Typically, Phase 1 studies are conducted in small numbers of healthy
volunteers or, on occasion, in patients afflicted with the target disease, to determine the
metabolic and pharmacological action of the product candidate in humans, the side effects
associated with increasing doses, and, if possible, to gain early evidence of effectiveness. In
Phase 2, studies are generally conducted in larger groups of patients having the target disease or
condition in order to validate clinical endpoints, and to obtain preliminary data on the
effectiveness of the product candidate and optimal dosing. This phase also helps determine further
the safety profile of the product candidate. In Phase 3, large-scale clinical trials are generally
conducted in hundreds of patients having the target disease or condition to provide sufficient data
for the statistical proof of effectiveness and safety of the product candidate as required by U.S.
and foreign regulatory agencies.
Various federal, state, local, and foreign statutes and regulations also govern testing,
manufacturing, labeling, distribution, storage and record-keeping related to such products and
their promotion and marketing. The process of obtaining these approvals and the compliance with
federal, state, local, and foreign statutes and regulations require the expenditure of substantial
time and financial resources. In addition, the current regulatory and political environment at FDA
could lead to increased testing and data requirements which could impact regulatory timelines and
costs.
There can be no assurance that in the event we seek to develop any product candidate, we or
any of our partners would be able to satisfy one or more of these requirements to conduct
pre-clinical or clinical trials or receive any regulatory approvals.
Employees
As of July 31, 2009, STI had two employees and six consultants and advisors. A significant
number of our management and our other employees and consultants have worked or consulted with
pharmaceutical, biotechnology or medical product companies. While we have been successful in
attracting skilled and experienced scientific personnel, there can be no assurance that we will be
able to attract or retain the necessary qualified employees and/or consultants in the future. None
of our employees are covered by collective bargaining agreements and we consider relations with our
employees to be good.
Properties
STI currently leases approximately 6,800 square feet of office, warehouse and laboratory space
in San Diego, California. STIs lease expires in August 2014, but includes an option to extend the
term of such lease for one additional four year period. STI believes that its current facilities
are adequate to meet its needs for the foreseeable future and that, should it be needed, suitable
additional space will be available to accommodate expansion of its operations on commercially
reasonable terms.
13
An investment in our company involves a significant level of risk. You should carefully
consider the risks described below, together with all of the other information in this Current
Report on Form 8-K, including all Form 10 information. The risks described below are not the only
risks facing us. Additional risks and uncertainties not currently known to us or that we currently
deem to be immaterial may also materially and adversely affect our business. If any of the
following risks actually occur, our business, financial condition and results of operations could
suffer, and the trading price of our common stock could decline.
Risks Related to Our Business
We are a development-stage company subject to all of the risks and uncertainties of a new business,
including the risk that we or our partners may never develop or market any products or generate
revenues. We are currently unprofitable and cannot assure you that we will ever become or remain
profitable.
We are a recently formed development-stage biopharmaceutical company that has only recently
begun operations and commenced research and development activity. There is no assurance that we
will be able to satisfactorily develop our platform technology for the generation of fully human
monoclonal antibodies for research, diagnostic and therapeutic use, identify and isolate
therapeutics product candidates, or develop, market and commercialize these candidates. We do not
expect any of our product candidates to be commercially available for a number of years, if at all.
Even if we are able to commercialize our product candidates, there is no assurance that these
candidates would generate revenues or that any revenues generated would be sufficient for us to
become profitable or thereafter maintain profitability. We have not generated any revenues to date,
and we do not expect to generate any such revenues for a number of years. Additionally, we have
incurred operating losses since our inception and we expect to continue to incur significant
operating losses for the foreseeable future. We also expect to continue to incur significant
operating expenditures in the foreseeable future as we expand our research and development
activities and seek to develop our technologies and product candidates. In the event that our
operating losses are greater than anticipated or continue for longer than anticipated, we will need
to raise significant additional capital sooner, or in greater amounts, than otherwise anticipated
in order to be able to continue development of our technologies and maintain our operations.
We expect that we will require additional financing, and an inability to raise the necessary
capital or to do so on acceptable terms would threaten the success of our business.
We believe that our current cash balances and cash equivalents, after giving effect to the
Financing, will be sufficient to meet our operating and capital requirements, as currently being
conducted, for at least one year, and will provide us the financial resources to continue to
develop our antibody libraries. However, because of the uncertainties in our business, including
the uncertainties discussed in this Risk Factors section, we cannot assure you that this will be
the case. Our future capital requirements will depend on many factors, including:
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the progress of the development of our core technology and any product candidates; |
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the number of product candidates we pursue; |
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the time and costs involved in obtaining regulatory approvals; |
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the costs involved in filing and prosecuting patent applications and enforcing or
defending patent claims; |
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our plans to establish sales, marketing and/or manufacturing capabilities; |
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our ability to establish, enforce and maintain selected strategic alliances and
activities required for product commercialization; and |
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our revenues, if any, from successful development and commercialization of any
product candidates. |
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In order to carry out our business plan and implement our strategy, including the continued
development of antibody libraries, we anticipate that we will need to obtain additional financing
from time to time and may choose to raise additional funds through strategic collaborations,
licensing arrangements, public or private equity or debt financing, a bank line of credit, asset
sales or other arrangements. We cannot be sure that any additional funding, if needed, will be
available on terms favorable to us or at all. Furthermore, any additional equity or equity-related
financing may be dilutive to our stockholders, and debt financing, if available, may subject us to
restrictive covenants and significant interest costs. If we obtain funding through a strategic
collaboration or licensing arrangement, we may be required to relinquish our rights to certain of
our technologies, products or marketing territories. In addition, certain investors, including
institutional investors, may be unwilling to invest in our securities since we are traded on the
Over-the-Counter Bulletin Board and not on a national securities exchange. Our inability to raise
capital when needed would harm our business, financial condition and results of operations, and
could cause our stock price to decline.
We have a limited operating history upon which to base an investment decision and we may be unable
to successfully develop our technology on any product candidates.
We are a development-stage company and have not demonstrated our ability to perform the
functions necessary for the successful development or commercialization of the technology we are
seeking to develop. The successful development, and any commercialization, of our technology and
any product candidates would require us to successfully perform a variety of functions, including:
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developing our technology platform; |
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identifying, developing, manufacturing and commercializing product candidates; |
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entering into successful licensing and other arrangements with product development
partners; |
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participating in regulatory approval processes; |
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formulating and manufacturing products; and |
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conducting sales and marketing activities. |
Our operations have been limited to organizing our company and acquiring, developing and
securing our proprietary technology. These operations provide a limited basis for you to assess our
ability to continue to develop our technology, identify product candidates, develop and
commercialize any product candidates we are able to identify and enter into successful
collaborative arrangements with other companies, as well as for you to assess the advisability of
investing in our securities. Each of these requirements will require substantial time, effort and
financial resources.
Our antibody libraries and potential product candidates are in early stages of development.
The U.S. Food and Drug Administration (FDA) regulates, among other things, the development,
testing, manufacture, safety, efficacy, record-keeping, labeling, storage, approval, advertising,
promotion, sale and distribution of biopharmaceutical products. We are in the early stages of
developing our antibody libraries and any potential product candidates that we develop will require
extensive pre-clinical and clinical testing before they will be approved by the FDA or another
regulatory authority in a jurisdiction outside the U.S. We have not yet developed any product
candidate; if we were to do so there are a number of requirements that we would be required to
satisfy in order to begin conducting pre-clinical trials and there can be no assurance that we will
develop product candidates or complete the steps necessary to allow us to commence these trials.
Even if we were to conduct pre-clinical trials, we cannot predict with any certainty the results of
such testing or whether such trials would yield sufficient data to permit us, or those with whom we
collaborate, to proceed with clinical development and ultimately submit an application for
regulatory approval of our product candidates in the U.S. or abroad, or whether such applications
would be approved by the appropriate regulatory agency.
Our product development efforts may not be successful.
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Our product development efforts are designed to focus on novel therapeutic approaches and
technologies that have not been widely studied. We are applying these approaches and technologies
in our attempt to discover new treatments for conditions that are also the subject of research and
development efforts of many other companies. These approaches and technologies may never be
successful.
Our failure to find third party collaborators to assist or share in the costs of product
development could materially harm our business, financial condition and results of operations.
Our strategy for the development and commercialization of our proprietary product candidates
may include the formation of collaborative arrangements with third parties. Potential third parties
include biopharmaceutical, pharmaceutical and biotechnology companies, academic institutions and
other entities. Third-party collaborators may assist us in:
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funding research, preclinical development, clinical trials and manufacturing; |
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seeking and obtaining regulatory approvals; and |
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successfully commercializing any future product candidates. |
If we are not able to establish further collaboration agreements, we may be required to
undertake product development and commercialization at our own expense. Such an undertaking may
limit the number of product candidates that we will be able to develop, significantly increase our
capital requirements and place additional strain on our internal resources. Our failure to enter
into additional collaborations could materially harm our business, financial condition and results
of operations.
In addition, our dependence on licensing, collaboration and other agreements with third
parties may subject us to a number of risks. These agreements may not be on terms that prove
favorable to us and may require us to relinquish certain rights in our technologies and product
candidates. To the extent we agree to work exclusively with one collaborator in a given area, our
opportunities to collaborate with other entities could be curtailed. Lengthy negotiations with
potential new collaborators may lead to delays in the research, development or commercialization of
product candidates. The decision by our collaborators to pursue alternative technologies or the
failure of our collaborators to develop or commercialize successfully any product candidate to
which they have obtained rights from us could materially harm our business, financial condition and
results of operations.
We expect to rely on third parties to gain access to antigens.
We expect to gain access to antigens through contractual arrangements with leading academic
researchers and companies involved in the identification and development of antigens or from
publicly available sources. In the event we are unable to access antigens in sufficient quantities,
or at all, we will be unable to execute our business plan. In addition, we may be unable to
purchase or secure access to antigens at a cost favorable to us, which may have an adverse impact
on our business and financial condition.
We expect to rely on third parties to conduct any clinical trials for our product candidates, and
if they do not properly and successfully perform their legal and regulatory obligations, as well as
their contractual obligations to us, we may not be able to obtain regulatory approvals for any
product candidates we develop.
In the event we develop product candidates, we expect to rely on contract research
organizations and other third parties to assist us in managing, monitoring and otherwise carrying
out these trials, including with respect to site selection, contract negotiation and data
management. Because we would not control these third parties, they may not treat our clinical
studies as their highest priority, or in the manner in which we would prefer, which could result in
delays. Moreover, if third parties did not successfully carry out their duties under their
agreements with us, if the quality or accuracy of the data they obtain is compromised due to
failure to adhere to our clinical protocols or regulatory requirements, or if they otherwise failed
to comply with clinical trial protocols or meet expected deadlines, the clinical trials conducted
on our behalf may not meet regulatory requirements. If our clinical trials do not meet regulatory
requirements or if these third parties need to be replaced, our clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval of some
or all of the product candidates we may develop.
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If we cannot compete successfully against other biopharmaceutical companies, we may not be
successful in developing and commercializing our technology and our business will suffer.
The biopharmaceutical space is characterized by intense competition and rapid technological
advances. Even if we are able to develop our proprietary platform technology and an antibody
library, each will compete with a number of existing and future technologies and product candidates
developed, manufactured and marketed by others. Specifically, we will compete against fully
integrated pharmaceutical companies and smaller companies that are collaborating with larger
pharmaceutical companies, academic institutions, government agencies and other public and private
research organizations. Many of these competitors have technologies already FDA-approved or in
development. In addition, many of these competitors, either alone or together with their
collaborative partners, operate larger research and development programs and have substantially
greater financial resources than we do, as well as significantly greater experience in:
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developing product candidates and technologies generally; |
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undertaking pre-clinical testing and clinical trials; |
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obtaining FDA and other regulatory approvals of product candidates; |
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formulating and manufacturing product candidates; and |
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launching, marketing and selling product candidates. |
If our technology fails to compete effectively against third party technologies, our business
will be adversely impacted.
Because our development activities are expected to rely heavily on sensitive and personal
information, an area which is highly regulated by privacy laws, we may not be able to generate,
maintain or access essential patient samples or data to continue our research and development
efforts in the future on reasonable terms and conditions, which may adversely affect our business.
We may have access to very sensitive data regarding patients whose tissue samples are used in
our studies. This data will contain information that is personal in nature. The maintenance of this
data is subject to certain privacy-related laws, which impose upon us administrative and financial
burdens, and litigation risks. For instance, the rules promulgated by the Department of Health and
Human Services under the Health Insurance Portability and Accountability Act (HIPAA) create
national standards to protect patients medical records and other personal information in the
United States. These rules require that healthcare providers and other covered entities obtain
written authorizations from patients prior to disclosing protected health care information of the
patient to companies. If the patient fails to execute an authorization or the authorization fails
to contain all required provisions, then we will not be allowed access to the patients information
and our research efforts can be substantially delayed. Furthermore, use of protected health
information that is provided to us pursuant to a valid patient authorization is subject to the
limits set forth in the authorization (i.e., for use in research and in submissions to regulatory
authorities for product approvals). As such, we are required to implement policies, procedures and
reasonable and appropriate security measures to protect individually identifiable health
information we receive from covered entities, and to ensure such information is used only as
authorized by the patient. Any violations of these rules by us could subject us to civil and
criminal penalties and adverse publicity, and could harm our ability to initiate and complete
clinical studies required to support regulatory applications for our proposed products. In
addition, HIPAA does not replace federal, state, or other laws that may grant individuals even
greater privacy protections. We can provide no assurance that future legislation will not prevent
us from generating or maintaining personal data or that patients will consent to the use of their
personal information, either of which may prevent us from undertaking or publishing essential
research. These burdens or risks may prove too great for us to reasonably bear, and may adversely
affect our ability to achieve profitability or maintain profitably in the future.
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We may be exposed to liability claims associated with the use of hazardous materials and chemicals.
Our research and development activities may involve the controlled use of hazardous materials
and chemicals. Although we believe that our safety procedures for using, storing, handling and
disposing of these materials comply with federal, state and local laws and regulations, we cannot
completely eliminate the risk of accidental injury or contamination from these materials. In the
event of such an accident, we could be held liable for any resulting damages and any liability
could materially adversely affect our business, financial condition and results of operations. In
addition, the federal, state and local laws and regulations governing the use, manufacture,
storage, handling and disposal of hazardous or radioactive materials and waste products may require
us to incur substantial compliance costs that could materially harm our business.
If we are unable to retain and recruit qualified scientists and advisors, or if any of our key
executives, key employees or key consultants discontinues his or her employment or consulting
relationship with us, it may delay our development efforts or otherwise harm our business.
We are highly dependent on the key members of our management and scientific staff, especially
our Chief Executive Officer and President, Antonius Schuh, Ph.D., and our Chief Scientific Officer,
Henry Ji, Ph.D. The loss of any of our key employees or key consultants could impede the
achievement of our research and development objectives. Furthermore, recruiting and retaining
qualified scientific personnel to perform research and development work in the future is critical
to our success. We may be unable to attract and retain personnel on acceptable terms given the
competition among biotechnology, biopharmaceutical and health care companies, universities and
non-profit research institutions for experienced scientists. Certain of our current officers,
directors, scientific advisors and/or consultants or certain of the officers, directors, scientific
advisors and/or consultants hereafter appointed may from time to time serve as officers, directors,
scientific advisors and/or consultants of other biopharmaceutical or biotechnology companies. We do
not maintain key man insurance policies on any of our officers or employees. All of our employees
are employed at will and, therefore, each employee may leave our employment at anytime
We plan to grant stock options or other forms of equity awards in the future as a method of
attracting and retaining employees, motivating performance and aligning the interests of employees
with those of our stockholders. If we are unable to implement and maintain equity compensation
arrangements that provide sufficient incentives, we may be unable to retain our existing employees
and attract additional qualified candidates. If we are unable to retain our existing employees,
including qualified scientific personnel, and attract additional qualified candidates, our business
and results of operations could be adversely affected.
We will need to increase the size of our company and may not effectively manage our growth.
Our success will depend upon growing our business and our employee base. Over the next 12
months, we plan to add additional employees to assist us with research and development. Our future
growth, if any, may cause a significant strain on our management, and our operational, financial
and other resources. Our ability to manage our growth effectively will require us to implement and
improve our operational, financial and management systems and to expand, train, manage and motivate
our employees. These demands may require the hiring of additional management personnel and the
development of additional expertise by management. Any increase in resources devoted to research
and product development without a corresponding increase in our operational, financial and
management systems could have a material adverse effect on our business, financial condition, and
results of operations.
Any disruption in our research and development facilities could adversely affect our business,
financial condition and results of operations.
Our principal executive offices, which house our research and development programs, are
located in San Diego, California. Our facilities may be affected by natural or man-made disasters.
Earthquakes are of particular significance since our facilities are located in an earthquake-prone
area. We are also vulnerable to damage from other types of disasters, including power loss, attacks
from extremist organizations, fire, floods and similar events. In the event that our facilities
were affected by a natural or man-made disaster, we may be forced to curtail our
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operations and/or rely on third-parties to perform some or all of our research and development
activities. Although we believe we possess adequate insurance for damage to our property and the
disruption of our business from casualties, such insurance may not be sufficient to cover all of
our potential losses and may not continue to be available to us on acceptable terms, or at all. In
the future, we may choose to expand our operations in either our existing facilities or in new
facilities. If we expand our worldwide manufacturing locations, there can be no assurance that this
expansion will occur without implementation difficulties, or at all.
Risks Related to Our Intellectual Property
Our ability to protect our intellectual property rights will be critically important to the success
of our business, and we may not be able to protect these rights in the United States or abroad.
Our success, competitive position and future revenues will depend in part on our ability to
obtain and maintain patent protection for our product candidates, methods, processes and other
technologies, to prevent third parties from infringing on our proprietary rights and to operate
without infringing upon the proprietary rights of third parties. We will be able to protect our
proprietary rights from unauthorized use by third parties only to the extent that our proprietary
rights are covered by valid and enforceable patents or are effectively maintained as trade secrets.
We attempt to protect our proprietary position by filing U.S. and foreign patent applications
related to our proprietary technology, inventions and improvements that are important to the
development of our business. The company has one issued U.S. patent; examination of the European
equivalent currently is in progress, and a continuation application has been filed in the U.S. and
is now pending. However, the patent position of biopharmaceutical companies involves complex legal
and factual questions, and therefore we cannot predict with certainty whether any patent
applications that we have filed or that we may file in the future will be approved or any resulting
patents will be enforced. In addition, third parties may challenge, seek to invalidate or
circumvent any of our patents, once they are issued. Thus, any patents that we own or license from
third parties may not provide any protection against competitors. Any patent applications that we
have filed or that we may file in the future, or those we may license from third parties, may not
result in patents being issued. Also, patent rights may not provide us with adequate proprietary
protection or competitive advantages against competitors with similar technologies. Other patents
in this industry claim amplification to produce antibody libraries.
In addition, the laws of certain foreign countries do not protect our intellectual property
rights to the same extent as do the laws of the United States. If we fail to apply for intellectual
property protection or if we cannot adequately protect our intellectual property rights in these
foreign countries, our competitors may be able to compete more effectively against us, which could
adversely affect our competitive position, as well as our business, financial condition and results
of operations.
If any of our trade secrets, know-how or other proprietary information is disclosed, the value of
our trade secrets, know-how and other proprietary rights would be significantly impaired and our
business and competitive position would suffer.
Our success also depends upon the skills, knowledge and experience of our scientific and
technical personnel and our consultants and advisors, as well as our licensors. To help protect our
proprietary know-how and our inventions for which patents may be unobtainable or difficult to
obtain, we rely on trade secret protection and confidentiality agreements. To this end, we require
all of our employees, consultants, advisors and contractors to enter into agreements which prohibit
the disclosure of confidential information and, where applicable, require disclosure and assignment
to us of the ideas, developments, discoveries and inventions important to our business. These
agreements may not provide adequate protection for our trade secrets, know-how or other proprietary
information in the event of any unauthorized use or disclosure or the lawful development by others
of such information. If any of our trade secrets, know-how or other proprietary information is
disclosed, the value of our trade secrets, know-how and other proprietary rights would be
significantly impaired and our business and competitive position would suffer.
Third party competitors may seek to challenge the validity of our patents, thereby rendering them
unenforceable.
Claims that we infringe upon the rights of third parties may give rise to costly and lengthy
litigation, and we could be prevented from selling products, forced to pay damages, and defend
against litigation.
19
Third parties may assert patent or other intellectual property infringement claims against us
or our strategic partners or licensees with respect to our technologies and potential product
candidates. If our products, methods, processes and other technologies infringe upon the
proprietary rights of other parties, we could incur substantial costs and we may have to:
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obtain licenses, which may not be available on commercially reasonable terms, if at
all, any may be non-exclusive, thereby giving our competitors access to the same
intellectual property licensed to us; |
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redesign our products or processes to avoid infringement; |
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stop using the subject matter claimed in the patents held by others; |
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pay damages; and |
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defend litigation or administrative proceedings which may be costly whether we win
or lose, and which could result in a substantial diversion of our valuable management
resources. |
Even if we were to prevail, any litigation could be costly and time-consuming and would divert
the attention of our management and key personnel from our business operations. Furthermore, as a
result of a patent infringement suit brought against us or our strategic partners or licensees, we
or our strategic partners or licensees may be forced to stop or delay developing, manufacturing or
selling technologies or potential products that are claimed to infringe a third partys
intellectual property unless that party grants us or our strategic partners or licensees rights
to use its intellectual property. Ultimately, we may be unable to develop some of our technologies
or potential products or may have to discontinue development of a product candidate or cease some
of our business operations as a result of patent infringement claims, which could severely harm our
business.
Our position as a relatively small company may cause us to be at a significant disadvantage in
defending our intellectual property rights and in defending against infringement claims by third
parties.
Litigation relating to the ownership and use of intellectual property is expensive, and our
position as a relatively small company in an industry dominated by very large companies may cause
us to be at a significant disadvantage in defending our intellectual property rights and in
defending against claims that our technology infringes or misappropriates third party intellectual
property rights. Even if we are able to defend our position, the cost of doing so may adversely
affect our ability to grow, generate revenue or become profitable. Although we have not yet
experienced patent litigation, we may in the future be subject to such litigation and may not be
able to protect our intellectual property at a reasonable cost, or at all, if such litigation is
initiated. The outcome of litigation is always uncertain, and in some cases could include judgments
against us that require us to pay damages, enjoin us from certain activities or otherwise affect
our legal or contractual rights, which could have a significant adverse effect on our business.
Risks Related to Ownership of Our Common Stock
The market price of our common stock may fluctuate significantly, and investors in our common stock
may lose all or a part of their investment.
The market price of our common stock may fluctuate significantly in response to numerous
factors, some of which are beyond our control, such as:
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future issuances of common stock or other securities; |
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the addition or departure of key personnel; |
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the results of lawsuits; |
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announcements by us or our competitors of acquisitions, investments or strategic
alliances; and |
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general market conditions and other factors, including factors unrelated to our
operating performance. |
Further, the equity markets in general have recently experienced extreme price and volume
fluctuations. Continued market fluctuations could result in extreme volatility in the price of our
common stock, which could cause a decline in the value of our common stock. Price volatility of our
common stock might worsen if the trading volume of our common stock is low.
Some or all of the restricted shares of our common stock issued to former shareholders of
STI in connection with the Merger or held by other of our shareholders may be offered from time to
time in the open market pursuant to an effective registration statement or Rule 144, and these
sales may have a negative effect on the price of our common stock.
Trading of our common stock is limited, and trading restrictions imposed on us by applicable
regulations and by lockup agreements we have entered into with our principal shareholders may
further reduce our trading, making it difficult for our shareholders to sell their shares.
Trading of our common stock is currently conducted on the OTCBB. The liquidity of our common
stock is limited, not only in terms of the number of shares that can be bought and sold at a given
price, but also as it may be adversely affected by delays in the timing of transactions and
reduction in security analysts and the medias coverage of us, if at all. Additionally,
approximately 98.3% of our issued and outstanding shares of common stock are subject to lock-up
agreements, which limit sales of such shares for a period of 24 months following the closing of the
Merger.
The foregoing factors may result in lower prices for our common stock than might otherwise be
obtained and could also result in a larger spread between the bid and asked prices for our common
stock. In addition, without a large public float, our common stock is less liquid than the stock of
companies with broader public ownership, and, as a result, the trading price of our common stock
may be more volatile. In the absence of an active public trading market, an investor may be unable
to liquidate his investment in our common stock. Trading of a relatively small volume of our common
stock may have a greater impact on the trading price of our stock than would be the case if our
public float were larger. We cannot predict the price at which our common stock will trade at any
given time.
We do not expect to pay dividends on our common stock, and investors will be able to receive cash
in respect of their shares of our common stock only upon the sale of such shares.
We have no intention in the foreseeable future to pay any cash dividends on our common stock.
Therefore, an investor in our common stock may obtain an economic benefit from the common stock
only after an increase in its trading price and only then by selling the common stock.
Because our common stock is a penny stock, it may be more difficult for investors to sell shares
of our common stock, and the market price of our common stock may be adversely affected.
According to the definition adopted by the Securities and Exchange Commission (SEC), our
common stock is a penny stock because, among other things, its price is below $5.00 per share, it
is not listed on a national securities exchange and the Company does not meet certain net tangible
asset or average revenue requirements. Broker-dealers that sell penny stock must provide purchasers
of such stock with a standardized risk-disclosure document prepared by the SEC. This document
provides information about penny stock and the nature and level of risks involved in investing in
penny stock. A broker must also give a purchaser, orally or in writing, bid and offer quotations
and information regarding broker and salesperson compensation, make a written determination that
the penny stock is a suitable investment for the purchaser and obtain the purchasers written
agreement to the purchase. Broker-dealers must also provide customers that hold penny stock in
their accounts with such broker-dealer a monthly statement containing price and market information
relating to the penny stock. If a penny stock is sold to an investor in violation of the penny
stock rules, the investor may be able to cancel its purchase and get its money back.
If applicable, the penny stock rules may make it difficult for investors to sell their shares
of our common stock. Because of the rules and restrictions applicable to a penny stock, there is
less trading in penny stock, and the
21
market price of our common stock may be adversely affected. Also, many brokers choose not to
participate in penny stock transactions. Accordingly, investors may not always be able to publicly
resell their shares of our common stock at times and prices that they feel are appropriate.
Existing shareholders interest in us may be diluted by additional issuances of equity securities.
We may issue additional equity securities to fund future expansion and, possibly, pursuant to
employee benefit plans. We may also issue additional equity for other purposes. These securities
may have the same rights as our common stock or, alternatively, may have dividend, liquidation or
other preferences to our common stock. The issuance of additional equity securities will dilute the
holdings of existing shareholders and may reduce the share price of our common stock.
Directors, executive officers, principal shareholders and affiliated entities own a significant
percentage of our capital stock, and they may make decisions that you do not consider to be in your
best interests or those of our other shareholders.
As of the consummation of the Merger, our directors, executive officers and principal
shareholders beneficially owned, in the aggregate, over 83% of our outstanding voting securities.
As a result, if some or all of them acted together, they would have the ability to exert
substantial influence over the election of our board of directors and the outcome of issues
requiring approval by our shareholders. This concentration of ownership may also have the effect of
delaying or preventing a change in control of our company that may be favored by other
shareholders. This could prevent transactions in which shareholders might otherwise recover a
premium for their shares over current market prices.
Our amended and restated articles of incorporation and bylaws provide for indemnification of
officers and directors at our expense and limits their liability, which may result in a major cost
to us and hurt the interests of our shareholders because corporate resources may be expended for
the benefit of officers and/or directors.
Our amended and restated articles of incorporation, bylaws and applicable Colorado law provide
for the indemnification of our directors, officers, employees, and agents, under certain
circumstances, against attorneys fees and other expenses incurred by them in any litigation to
which they become a party arising from their association with or activities on our behalf. We will
also bear the expenses of such litigation for any of our directors, officers, employees, or agents,
upon such persons promise to repay us, therefore if it is ultimately determined that any such
person shall not have been entitled to indemnification. This indemnification policy could result in
substantial expenditures by us, which we will be unable to recover.
Compliance with changing regulations concerning corporate governance and public disclosure may
result in additional expenses.
There have been changing laws, regulations and standards relating to corporate governance and
public disclosure, including the Sarbanes-Oxley Act of 2002 (Sarbanes-Oxley), new regulations
promulgated by the SEC and rules promulgated by the national securities exchanges. These new or
changed laws, regulations and standards are subject to varying interpretations in many cases due to
their lack of specificity, and, as a result, their application in practice may evolve over time as
new guidance is provided by regulatory and governing bodies, which could result in continuing
uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to
disclosure and governance practices. As a result, our efforts to comply with evolving laws,
regulations and standards are likely to continue to result in increased general and administrative
expenses and a diversion of management time and attention from revenue-generating activities to
compliance activities. Members of our board of directors and our Chief Executive Officer and Chief
Financial Officer could face an increased risk of personal liability in connection with the
performance of their duties. As a result, we may have difficulty attracting and retaining qualified
directors and executive officers, which could harm our business. If the actions we take in our
efforts to comply with new or changed laws, regulations and standards differ from the actions
intended by regulatory or governing bodies, we could be subject to liability under applicable laws
or our reputation may be harmed.
In addition, Sarbanes-Oxley specifically requires, among other things, that we maintain
effective internal controls for financial reporting and disclosure of controls and procedures. In
particular, we must perform system and
22
process evaluation and testing of our internal controls over financial reporting to allow
management to report on the effectiveness of our internal controls over financial reporting, as
required by Section 404 of Sarbanes-Oxley. Our testing, or the subsequent testing by our
independent registered public accounting firm, when required, may reveal deficiencies in our
internal controls over financial reporting that are deemed to be material weaknesses. Our
compliance with Section 404 will require that we incur substantial accounting expense and expend
significant management efforts. We currently do not have an internal audit group, and we will need
to hire additional accounting and financial staff with appropriate public company experience and
technical accounting knowledge. Moreover, if we are not able to comply with the requirements of
Section 404 in a timely manner, or if we or our independent registered public accounting firm
identifies deficiencies in our internal controls over financial reporting that are deemed to be
material weaknesses, the market price of our stock could decline, and we could be subject to
sanctions or investigations by the SEC or other regulatory authorities, which would require
additional financial and management resources.
State securities laws may limit secondary trading, which may restrict the States in which and
conditions under which you can sell shares.
Secondary trading in the QuikByte Common Stock will not be possible in any state until the
QuikByte Common Stock is qualified for sale under the applicable securities laws of the state or
there is confirmation that an exemption, such as listing in certain recognized securities manuals,
is available for secondary trading in the state. If we fail to register or qualify, or to obtain or
verify an exemption for the secondary trading of, the QuikByte Common Stock in any particular
state, the common stock could not be offered or sold to, or purchased by, a resident of that state.
We currently do not intend and may not be able to qualify securities for resale in some or all of
the states that do not offer manual exemptions and require shares to be qualified before they can
be resold by our shareholders. In the event that a significant number of states refuse to permit
secondary trading in our common stock, the liquidity for the common stock could be significantly
impacted.
Item 2. Financial Information.
The information required by this Item 2 of Form 10 for QuikByte was previously reported in its
Annual Report on Form 10-K for the fiscal year ended December 31, 2008, filed with the SEC on March
30, 2009, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed with the
SEC on August 13, 2009.
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS OF SORRENTO
The following discussion and analysis of STIs financial condition and results of operations
should be read in conjunction with the financial statements and the related notes and other
information that are included elsewhere in this Current Report on Form 8-K. This discussion
contains forward-looking statements based upon current expectations that involve risks and
uncertainties, such as STIs 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 Cautionary Note Regarding
Forward-Looking Statements contained elsewhere in this Current Report on Form 8-K. Additionally,
you should read the Risk Factors section of this Current Report on Form 8-K for a discussion of
important factors that could cause actual results to differ materially from the results described
in or implied by the forward-looking statements contained in the following discussion and analysis.
Introduction
This managements discussion and analysis of financial condition and results of operations is
intended to provide investors with an understanding of STIs financial condition, changes in
financial condition and results of operations.
Overview
23
We are a development-stage biopharmaceutical company focused on applying and commercializing
our proprietary technology platform for the discovery and development of human therapeutic
antibodies for the treatment of a variety of disease conditions, including cancer, inflammation,
metabolic disease and infectious disease. We believe that our proprietary technology (the STI
Technology) will allow us to construct antibody libraries containing fully human antibodies. These
libraries will be designed to facilitate the rapid identification and isolation of highly specific,
antibody therapeutic product candidates that are fully human and that bind to disease targets
appropriate for antibody therapy.
Our objective is to construct a human antibody library and, either independently or through
one or more partnerships with pharmaceutical or biopharmaceutical organizations, to identify drug
development candidates derived from this library. We intend to focus our initial efforts toward
using our proprietary technology to create a fully human antibody library that will be the basis
for our subsequent development. Following the construction of our library, we plan to focus our
efforts primarily in the identification and isolation of human antibody drug candidates. In the
event we are successful in developing our antibody library and any product candidates, we intend to
actively seek partners with experience and expertise in the antibody drug development field in
order to engage in any clinical development of these candidates.
STI was originally incorporated as San Diego Antibody Company in California in 2006 and was
renamed Sorrento Therapeutics, Inc. and reincorporated in Delaware in 2009. QuikByte was originally
incorporated in Colorado in 1989. On July 14, 2009, STI, QuikByte, Merger Sub, Stockholders Agent
and Parent Representative entered into the Merger Agreement. Pursuant to the Merger, which was
consummated on September 21, 2009, Merger Sub merged with and into STI, the separate corporate
existence of Merger Sub terminated and STI became a wholly-owned subsidiary of QuikByte. Subject to
approval by QuikBytes shareholders, QuikByte intends to change its name to Sorrento Therapeutics,
Inc. and redomesticate from a corporation organized and existing under the laws of the State of
Colorado to a corporation organized and existing under the laws of the State of Delaware. Former
holders of STI Shares which now represent more than 50% of the outstanding shares of QuikByte
Common Stock have agreed to vote in favor of the preceding matters if a vote to approve them is
held within three months of the Closing Date. Among these holders are Drs. Schuh and Ji, Mr.
Zaniboni and OPKO.
Our principal executive offices are located at 6042 Cornerstone Ct. West, Suite B, San Diego,
CA 92121, and our telephone number at that address is (858) 205-4193. Our website is
www.sorrentotherapeutics.com. The contents of our website are not part of this Current Report on
Form 8-K.
Recent Events
On
September 21, 2009, QuikByte consummated its acquisition of STI pursuant to the terms of
the Merger Agreement. In accordance with the Merger Agreement, STI merged with and into Merger Sub,
with STI as the surviving corporation and as a wholly-owned subsidiary of QuikByte. At the
effective time of the Merger, all of the STI Shares were converted into the right to receive an
aggregate of 169,375,807 shares of QuikByte Common Stock. The consolidation effected by the Merger
will be accounted for as a reverse acquisition wherein STI will be treated as the acquirer for
accounting purposes since it will control the combined enterprise.
On June 10, 2009, STI entered into a Stock Purchase Agreement with OPKO, pursuant to which
OPKO purchased approximately 2.3 million shares of STIs Common Stock at a purchase price of $2.3
million (the OPKO Investment). As previously discussed, STI also entered into the License
Agreement with OPKO.
Immediately prior and as a condition to the Merger Closing, QuikByte received an aggregate
investment of $2.0 million from the Investors in consideration for an aggregate of 44,634,374
shares of QuikByte Common Stock (the Financing). The Investors included affiliates of Dr. Phillip
Frost, Chairman and Chief Executive Officer of OPKO , which was a 34.8% stockholder of STI prior to
the Merger, an entity in which Mr. Glenn Halpryn, a director of the Company and its former
Chairman, President and Chief Executive Officer, and Mr. Steven Jerry Glauser, a greater than 5%
shareholder of the Company, are members, Mr. Noah Silver, a former director and Vice President,
Secretary and Treasurer of the Company, and Mr. Ronald Stein, a former director of the Company.
Proceeds from the Financing are expected to be used to fund the Companys general working capital
and post-Merger research and development activities.
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Critical Accounting Policies
STIs financial statements are prepared in accordance with generally accepted accounting
principles. The preparation of these financial statements requires STI to make estimates and
assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related
disclosures. STI evaluates its estimates and assumptions on an ongoing basis. STIs estimates are
based on historical experience and various other assumptions that it believes to be reasonable
under the circumstances. STIs actual results could differ from these estimates.
The Company considers all highly liquid investments with original maturities of 90 days or
less to be cash equivalents.
Results of Operations
The following discussion of STIs operating results explains material changes in STIs results
of operations for the three months and six months ended June 30, 2009 and year ended December 31,
2008 compared to their respective prior periods. The discussion should be read in conjunction with
the financial statements and related notes and pro forma financial information included elsewhere
in this Current Report on Form 8-K.
Three Months Ended June 30, 2009 Compared to the Three Months Ended June 30, 2008
Revenue. STI had no revenue during the three months ended June 30, 2009 and 2008 as it has not
yet developed any product candidates for commercialization or received any licensing or royalty
payments.
General and Administrative Expenses. General and administrative expenses for the three months
ended June 30, 2009 and 2008 were $24,769 and $3,991, respectively. The increase of approximately
$20,800 is primarily attributable to legal fees incurred in connection with the OPKO Investment and
other general legal matters.
Interest Income. Interest income for the three months ended June 30, 2009 and 2008 was $1,175
and $0, respectively. This increase is due to interest earned on the cash proceeds from the OPKO
Investment.
Net Loss. Net loss for the three months ended June 30, 2009 and 2008 was $23,594 and $3,991,
respectively. The increase in net loss of $19,603 is attributable to legal fees incurred in
connection with the OPKO Investment and the Merger, offset by an increase of $1,175 in interest
income.
Six Months Ended June 30, 2009 Compared to the Six Months Ended June 30, 2008
Revenue. STI had no revenue during the six months ended June 30, 2009 and 2008.
General and Administrative Expenses. General and administrative expenses for the six months
ended June 30, 2009 and 2008 were $24,769 and $3,991, respectively. The increase of approximately
$20,800 is primarily attributable to legal fees incurred in connection with the OPKO Investment and
other general legal matters.
Interest Income. Interest income for the six months ended June 30, 2009 and 2008 was $1,175
and $0, respectively. This increase is due to interest earned on the cash proceeds from the OPKO
Investment.
Net Loss. Net loss for the six months ended June 30, 2009 and 2008 was $24,394 and $4,791,
respectively. The increase in net loss of $19,603 is attributable to legal fees incurred in
connection with the OPKO Investment and the Merger, partially offset by an increase of $1,175 in
interest income.
Year Ended December 31, 2008 Compared to the Year Ended December 31, 2007
Revenue. STI had no revenue during the years ended December 31, 2008 and 2007.
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General and Administrative Expenses. General and administrative expenses for the years ended
December 31, 2008 and 2007 were $27,362 and $15,502, respectively. The increase of approximately
$11,900 is primarily attributable to an increase in legal and filing fees related to seeking
patents on the STI Technology.
Other Income. Other income for the years ended December 31, 2008 and 2007 was $2,417 and $0,
respectively. The increase in other income is attributable to a one-time write-off of amounts
payable by STI to its founders.
Net Loss. Net loss for the years ended December 31, 2008 and 2007 was $25,745 and $16,302,
respectively. The increase in net loss of $9,443 is attributable to an increase in legal and filing
fees related to seeking patents on the STI Technology.
Liquidity and Capital Resources
As of June 30, 2009 STI had approximately $2.3 million in cash and cash equivalents,
attributable to the OPKO Investment, compared to $0 as of December 31, 2008.
Cash Flows from Operating Activities. Net cash used in operating activities was $23,338 for
the six months ended June 30, 2009 as compared to $0 for the six months ended June 30, 2008. For
the six months ended June 30, 2009, net cash used in operating activities related primarily to an
increase in other current assets of $60,000 for legal fees related to the Merger, offset by an
increase of approximately $107,000 in accounts payable, which is attributable to accrued legal
fees.
STI expects to continue to incur substantial and increasing losses and have negative net cash
flows from operating activities as it seeks to expand its technology portfolio and engages in
research and development activities.
Cash Flows from Financing Activities. Cash provided by financing activities for the six months
ended June 30, 2009 was $2.3 million, all of which is related to the OPKO Investment. Cash used in
investing activities for the six months ended June 30, 2008 was $0.
Future Liquidity Needs. From inception through June 30, 2009, STI has financed its operations
through private equity financing, as STI has not generated any revenue from operations to date, and
does not expect to generate revenue for several years, if ever. STI will need to raise additional
capital before it exhausts its current cash resources in order to continue to fund its research and
development, including its long-term plans for pre-clinical trials and new product development, as
well as to fund operations generally. As and if necessary, STI will seek to raise additional funds
through various potential sources, such as equity and debt financings, or through corporate
collaboration and license agreements. We can give no assurances that STI will be able to secure
such additional sources of funds to support its operations, or, if such funds are available to STI,
that such additional financing will be sufficient to meet its needs.
Based on STIs resources at June 30, 2009, and its current plan of expenditure on research and
development programs, STI believes that, with the proceeds received from the Financing, it will
have sufficient capital to fund its operations for at least 12 months. STIs actual cash
requirements may vary materially from those now planned, however, because of a number of factors,
including the pursuit of development of product candidates, competitive and technical advances,
costs of commercializing any potential product candidates, and costs of filing, prosecuting,
defending and enforcing any patent claims and any other intellectual property rights. If STI is
unable to raise additional funds when needed, it may not be able to develop any product candidates,
it could be required to delay, scale back or eliminate some or all of its research and development
programs and it may need to wind down its operations altogether. Each of these alternatives would
have a material adverse effect on our business.
To the extent that STI raises additional funds by issuing equity or debt securities, its
shareholders may experience additional significant dilution and such financing may involve
restrictive covenants. To the extent that STI raises additional funds through collaboration and
licensing arrangements, it may be necessary to relinquish some rights to its technologies or its
product candidates, or grant licenses on terms that may not be favorable to STI. These things may
have a material adverse effect on our business.
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Additionally, recent global market and economic conditions have been unprecedented and
challenging with tighter credit conditions and recession in most major economies. As a result of
these market conditions, the cost and availability of credit has been and may continue to be
adversely affected by illiquid credit markets and wider credit spreads. Concern about the stability
of the markets generally and the strength of counterparties specifically has led many lenders and
institutional investors to reduce, and in some cases, cease to provide credit to businesses and
consumers. These factors have lead to a decrease in spending by businesses and consumers alike, and
a corresponding decrease in global infrastructure spending. Continued turbulence in the U.S. and
international markets and economies and prolonged declines in business and consumer spending may
adversely affect STIs liquidity and financial condition, including its ability to access the
capital markets to meet liquidity needs.
Off-Balance Sheet Arrangements
Since our inception through June 30, 2009, we have not engaged in any off-balance sheet
arrangements as defined in Item 303(a)(4) of Regulation S-K.
STIs principal corporate office is located at 6042 Cornerstone Ct. West, Suite B, San Diego,
CA 92121. STI currently leases approximately 6,800 square feet of office, warehouse and laboratory
space in San Diego, California. STIs lease expires in August 2014, but includes an option to
extend the term of such lease for one additional four year period. STI believes that its current
facilities are adequate to meet its needs for the foreseeable future and that, should it be needed,
suitable additional space will be available to accommodate expansion of its operations on
commercially reasonable terms.
QuikBytes principal corporate office is located at 4400 Biscayne Blvd, Suite 950, Miami,
Florida. QuikByte rents this space, approximately one thousand square feet, from Frost Real Estate
Holdings, LLC which is a company controlled by Dr. Phillip Frost, who beneficially owns
approximately 1.735% of the Companys issued and outstanding common stock. The Company does not
expect to use this space any further.
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Item 4. |
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Security Ownership of Certain Beneficial Owners and Management. |
As of the closing date of the Merger, the following table sets forth information regarding the
beneficial ownership of our common stock by:
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Our Chief Executive Officer and our other executive officers, including those
persons who served as our Chief Executive Officer during our fiscal year ended
December 31, 2008 (collectively, the Named Executive Officers); |
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Each of our directors; |
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All of our directors and Named Executive Officers, collectively; and |
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Each person who is known by us to beneficially own more than 5% of our common
stock. |
Unless otherwise noted, we believe that all persons named in the table have sole voting and
investment power with respect to all shares of our common stock beneficially owned by them. All
percentages have been calculated based upon 225,084,127 shares of our common stock issued and
outstanding as of the close of business on September 21, 2009,
the closing date of the Merger,
after giving effect to the Financing.
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Percentage of |
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Outstanding Common |
Name and Address of Beneficial Owner |
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Number of Shares |
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Shares |
Directors and Named Executive Officers: |
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Dr. Antonius
Schuh, Chairman and Chief Executive Officer
c/o Sorrento Therapeutics, Inc.
6042 Cornerstone Ct. West, Suite B
San Diego, CA 92121
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25,484,329 |
(1) |
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11.3 |
% |
|
|
|
|
|
|
|
|
|
Dr. Henry
Ji, Director, Chief Scientific Officer & Secretary
c/o Sorrento Therapeutics, Inc.
6042 Cornerstone Ct. West, Suite B
San Diego, CA 92121 |
|
|
52,754,032 |
(2) |
|
|
23.4 |
% |
|
|
|
|
|
|
|
|
|
Ernst-Güenter Afting, Director c/o Sorrento Therapeutics, Inc.
6042 Cornerstone Ct. West, Suite B
San Diego, CA 92121 |
|
|
557,930 |
(9) |
|
|
* |
|
|
|
|
|
|
|
|
|
|
Lewis Shuster, Director
c/o Sorrento Therapeutics, Inc.
6042 Cornerstone Ct. West, Suite B
San Diego, CA 92121 |
|
|
669,516 |
(9) |
|
|
* |
|
|
|
|
|
|
|
|
|
|
Dr. S. James Freedman, Director
4400 Biscayne Boulevard
Miami, Florida 33137
|
|
|
111,586 |
(9) |
|
|
* |
|
|
|
|
|
|
|
|
|
|
Glenn L. Halpryn, Director and Former
Principal Executive Officer
4400 Biscayne Boulevard, Suite 950
Miami, Florida 33137
|
|
|
18,829,503.7 |
(3)(9) |
|
|
8.4 |
% |
|
|
|
|
|
|
|
|
|
Dr. Curtis Lockshin, Director 4400 Biscayne Boulevard, Suite 950
Miami, Florida 33137 |
|
|
0 |
(9) |
|
|
* |
|
|
|
|
|
|
|
|
|
|
Alan Jay
Weisberg, Chief Financial and Accounting Officer |
|
|
78,592.5 |
|
|
|
* |
|
2500 North Military Trail, Suite 206
Boca Raton, Florida 33431 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kevin R.
Keating, Former Principal Executive Officer and
Former Principal
Financial Officer |
|
|
0 |
|
|
|
* |
|
190 Lakeview Way
Vero Beach, Florida 32963 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All Officers and Directors as a Group |
|
|
98,486,176.2 |
(5) |
|
|
43.8 |
% |
(including certain former officers) (9
Persons)(4) |
|
|
|
|
|
|
|
|
28
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of |
|
|
|
|
|
|
Outstanding Common |
Name and Address of Beneficial Owner |
|
Number of Shares |
|
Shares |
Certain Beneficial Owners: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPKO Health, Inc. |
|
|
59,015,257 |
(6) |
|
|
26.2 |
% |
4400 Biscayne Boulevard
Suite 900
Miami, Florida 33137 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stephen Zaniboni |
|
|
25,484,329 |
(7) |
|
|
11.3 |
% |
c/o Sorrento Therapeutics, Inc.
6042 Cornerstone Ct. West, Suite B
San Diego, CA 92121 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Steven Jerry Glauser |
|
|
21,292,847.4 |
(8) |
|
|
9.5 |
% |
1400 16th Street
Suite 510
Denver, Colorado 80202 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Halpryn Group VI, LLC |
|
|
17,184,228 |
|
|
|
7.6 |
% |
4400 Biscayne Boulevard
Suite 950
Miami, Florida 33137 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
2,548,432 of these shares are being held in escrow pursuant to the Escrow
Agreement, dated September 21, 2009, by and among the Company and the former stockholders of STI
(the Escrow Agreement). |
|
(2) |
|
5,096,865 of these shares are being held in escrow pursuant to the Escrow Agreement.
|
|
(3) |
|
Includes 17,184,228 shares of QuikByte Common Stock held by Halpryn Group VI, LLC,
of which Mr. Halpryn is a member, and 781,102 shares of Common Stock held by IVC Investors, LLLP,
in which Mr. Halpryn has an interest. Mr. Halpryn disclaims beneficial ownership of the shares of
QuikByte Common Stock held by each of Halpryn Group VI, LLC and IVC Investors, LLLP, except to the
extent of any pecuniary interest therein. |
|
(4) |
|
Comprised of: Dr. Antonius Schuh; Dr. Henry Ji; Dr. Ernst-Güenter Afting;
Lewis Shuster; Dr. James Freedman; Glenn L. Halpryn; Dr. Curtis Lockshin; Alan Jay Weisberg and
Kevin R. Keating. |
|
(5) |
|
7,645,297 of these shares are being held in escrow pursuant
to the Escrow Agreement. Does not include options to purchase shares of QuikByte Common Stock which are not exercisable within 60 days. |
|
(6) |
|
5,901,525 of these shares are being held in escrow pursuant to the Escrow Agreement. |
|
(7) |
|
2,548,432 of these shares are being held in escrow pursuant to the Escrow Agreement. |
|
(8) |
|
Includes 17,184,228 shares of QuikByte Common Stock held by Halpryn Group VI, LLC,
of which Mr. Glauser is a member. Mr. Glauser disclaims beneficial ownership of the shares of
QuikByte Common Stock held by Halpryn Group VI, LLC, except to the extent of any pecuniary interest
therein. |
|
(9) |
|
Does not include options to purchase 40,000 shares of
QuikByte Common Stock which are not exercisable within 60 days. |
|
|
|
Item 5. |
|
Directors and Executive Officers. |
The following table sets forth information concerning our executive officers and directors,
including their ages, as of September 18, 2009:
|
|
|
|
|
|
|
Name |
|
Age |
|
Title(s) |
Dr. Antonius Schuh
|
|
|
46 |
|
|
Chairman and Chief Executive Officer |
Dr. Henry Ji
|
|
|
45 |
|
|
Director, Chief Scientific Officer & Secretary |
Alan Jay Weisberg
|
|
|
63 |
|
|
Chief Financial and Accounting Officer |
Dr. Ernst-Günter Afting
|
|
|
67 |
|
|
Director |
Dr. James Freedman
|
|
|
43 |
|
|
Director |
Glenn L. Halpryn
|
|
|
49 |
|
|
Director |
Dr. Curtis Lockshin
|
|
|
49 |
|
|
Director |
Lewis J. Shuster
|
|
|
54 |
|
|
Director |
29
Dr. Antonius Schuh, Chairman of the Board and Chief Executive Officer
Antonius Schuh, Ph.D., age 46, co-founded STI in January 2006 and has served as its Chairman
since such time and as its Chief Executive Officer since November 2008. Dr. Schuh was appointed to
serve as our Chairman of the Board and Chief Executive Officer effective upon the closing of the
Merger. From April 2006 to September 2008, Dr. Schuh served as Chief Executive Officer of AviaraDx
(now bioTheranostics, Inc., a bioMerieux company), a molecular diagnostic testing company that is
focused on clinical applications in oncology. From March 2005 to April 2006, Dr. Schuh was Chief
Executive Officer of Arcturus Bioscience Inc., a developer of laser capture microdissection and
reagent systems for microgenomics. From December 1996 to February 2005, Dr. Schuh was employed by
Sequenom Inc., a publicly traded diagnostic testing and genetics analysis company. He started with
Sequenom as a Managing Director and was promoted to Executive Vice President, Business Development
and Marketing, and from May 2000 to February 2005, served as Sequenoms President and Chief
Executive Officer. He also previously served as the Head of Business Development at Helm AG, an
international trading and distribution corporation for chemical and pharmaceutical products, and in
medical and regulatory affairs positions with Fisons Pharmaceuticals (now part of Sanofi-Aventis).
Since March 2009, Dr. Schuh has been appointed to the board of directors of Diogenix, Inc., a
privately held molecular diagnostic company, and since May 2009, he has served as a director of
Transgenomic, Inc., a public biotechnology company focused on genetic analysis and molecular
diagnostics. Dr. Schuh is a certified pharmacist and earned his Ph.D. in pharmaceutical chemistry
from the University of Bonn, Germany.
Dr. Henry Ji, Director, Chief Scientific Officer & Secretary
Henry Ji, Ph.D., age 45, co-founded STI in January 2006 and has served as its Chief Scientific
Officer since November 2008, as a director since January 2006 and as its Secretary since September
2009. Dr. Ji was appointed to serve as our Chief Scientific Officer effective upon the closing of
the Merger. In 2002, Dr. Ji founded BioVintage, Inc., a research and development company focusing
on innovative life science technology and product development, and has served as its President
since 2002. From 2001 to 2002 Dr. Ji served as Vice President of CombiMatrix Corporation, a
publicly traded biotechnology company that develops proprietary technologies, including products
and services in the areas of drug development, genetic analysis, molecular diagnostics and
nanotechnology. During his tenure at CombiMatrix, Dr. Ji was responsible for strategic technology
alliances with biopharmaceutical companies. From 1999 to 2001, Dr. Ji served as Director of
Business Development, and in 2001 as Vice President, of Stratagene Corporation (later acquired by
Agilent Technologies, Inc.) where he was responsible for novel technology and product licensing and
development. In 1997, Dr. Ji co-founded Stratagene Genomics, Inc., a wholly owned subsidiary of
Stratagene Corporation, and served as its President and Chief Executive Officer from its founding
until 1999. Dr. Ji is the holder of several issued and pending patents in the life science research
field and is the sole inventor of STIs intellectual property. Dr. Ji has a Ph.D. in Animal
Physiology from the University of Minnesota and a B.S. in Biochemistry from Fudan University. Dr.
Ji was selected as a director nominee by Dr. Schuh pursuant to the terms of the Merger Agreement.
Dr. Ernst-Güenter Afting, Director
Ernst-Güenter Afting, Ph.D., M.D., age 67, was appointed to serve as a director of QuikByte
since the closing of the Merger. From 1995 until his retirement in 2006, Dr. Afting served as
President and Chief Executive Officer of the National Research Center for Environment and Health,
GSF-National Research Center for Environment and Health GmbH, a governmental research center in
Munich, Germany. From 1993 to 1995, he served as President and Chief Executive Officer of Roussel
UCLAF, Paris. Dr. Afting was also a member of the board of the Pharmaceutical Division of Hoechst
Group from 1984 to 1993 and was Chairman and Chief Executive Officer of the Divisional
Pharmaceutical Board of Hoechst from 1992-1993. Dr. Afting was a member of the advisory committee
on science and technology to German Chancellor Helmut Kohl from 1996 to 1997 and from 1996 to 2005
was a member of the German National Advisory Committee on Health Research to the State Secretaries
of Science, Technology and Health. Dr. Afting has been a member of the medical faculty at the
University of Goettingen since 1985. Dr. Afting currently serves on the boards of Sequenom, Inc.,
Intercell AG, Enanta Pharmaceuticals, Inc. and Olympus Europa GmbH. He received his Ph.D. in
Chemistry and M.D. from the University of Freiburg/Breisgau, Germany. Dr. Afting was selected as a
director nominee by Dr. Schuh pursuant to the terms of the Merger Agreement.
30
Dr. S. James Freedman, Director
S. James Freedman, M.D., Ph.D., age 43, has served as Executive Vice President of R&D and
Business Development of OPKO since June 2009. Dr. Freedman was appointed to serve as a director of
QuikByte effective upon the closing of the Merger. Prior to joining OPKO, from January 2008 to June
2009 Dr. Freedman served as Chief Executive Officer, President, Chief Medical Officer and a
director of Locus Pharmaceuticals, Inc., a private biotechnology company in Blue Bell, PA focused
on the discovery and development of novel computationally designed drugs for cancer and
inflammation. From 2006 to January 2008, Dr. Freedman served as a Senior Director, Clinical
Research with Merck & Co., Inc. where he conducted and supervised drug development programs,
including those dealing with RNA interference modalities. Dr. Freedman served as a Director,
Clinical Research at Merck from 2004 to 2006 and Associate Director, Clinical Research from 2003 to
2004. Prior to joining Merck, Dr. Freedman served as a Research Associate at the Beth Israel
Deaconess Medical Center at Harvard University and conducted postdoctoral research at the
Dana-Farber Cancer Institute at Harvard University. Dr. Freedman received his M.D. and Ph.D.
degrees from Tufts University in Boston, Massachusetts and his B.Sc. degree from McGill University
in Montreal, Quebec. He is triple Board-certified in Internal Medicine and Hematology & Oncology.
Dr. Freedman was selected as a director nominee by OPKO pursuant to the terms of the Merger
Agreement.
Glenn L. Halpryn, Director
Glenn L. Halpryn, age 48, has been a director of QuikByte since July 2008. From July 2008 to
August 2009, Mr. Halpryn served as our Chairman of the Board, Chief Executive Officer and
President. Mr. Halpryn also serves as a director of Castle Brands Inc., a developer and
international marketer of premium branded spirits whose shares are traded on the NYSE Amex
(formerly known as the American Stock Exchange), and a director of Ideation Acquisition Corp., a
publicly traded special purpose acquisition corporation seeking to effect a merger in the digital
media sector. Mr. Halpryn has also served as a director of Winston Pharmaceuticals, Inc., a
publicly held corporation and the parent company of Winston Laboratories, Inc., since September
2008. Mr. Halpryn served as the Chairman of the Board and Chief Executive Officer of Getting Ready
Corporation, a publicly held shell corporation, from December 2006 until its merger with Winston
Laboratories in September 2008. Mr. Halpryn served as the Chairman of the Board, Chief Executive
Officer and President of clickNsettle.com, Inc., a publicly held shell corporation, from October
2007 until September 2008, following its merger with Cardo Medical, LLC. Mr. Halpryn was the
President and Secretary and a director of Longfoot Communications Corp., a publicly held shell
corporation, from March 2008 until its merger with Kidville Holdings, LLC in August 2008. Mr.
Halpryn served as a director of Ivax Diagnostics, Inc., a publicly held corporation, from October
2002 until September 2008. Mr. Halpryn was Chairman of the Board and Chief Executive Officer of
Orthodontix, Inc., a publicly held corporation, from April 2001 until Orthodontix merged with
Protalix BioTherapeutics, Inc. in December 2006. Mr. Halpryn is also Chief Executive Officer and a
director of Transworld Investment Corporation (TIC), serving in such capacity since June 2001.
Since 2000, Mr. Halpryn has been an investor and the managing member of investor groups that were
joint venture partners in 26 land acquisition and development projects with one of the largest home
builders in the country. From 1984 to June 2001, Mr. Halpryn served as Vice President/Treasurer of
TIC. From 1999, Mr. Halpryn also served as Vice President of Ivenco, Inc. (Ivenco) until Ivencos
merger into TIC in June 2001. In addition, since 1984, Mr. Halpryn has been engaged in real estate
investment and development activities. From April 1988 through June 1998, Mr. Halpryn was Vice
Chairman of Central Bank, a Florida state-chartered bank. Since June 1987, Mr. Halpryn has been the
President of and beneficial holder of stock of United Security Corporation, a broker-dealer
registered with FINRA. From June 1992 through May 1994, Mr. Halpryn served as the Vice President,
Secretary-Treasurer of Frost Hanna Halpryn Capital Group, Inc., a blank check company whose
business combination was effected in May 1994 with Sterling Healthcare Group, Inc. From June 1995
through October 1996, Mr. Halpryn served as a member of the Board of Directors of Sterling
Healthcare Group, Inc.
31
Dr. Curtis Lockshin, Director
Curtis Lockshin, age 48, has been a director of QuikByte since July 2008. Dr. Lockshin has
served as a director of Winston Pharmaceuticals, Inc., a publicly held corporation and the parent
company of Winston Laboratories, Inc., since September 2008. Dr. Lockshin served as a director of
Getting Ready Corporation, a publicly held shell corporation, from December 2006 until its merger
with Winston Laboratories in September 2008. Dr. Lockshin served as a director of clickNsettle.com,
Inc., a publicly held shell corporation, from October 2007 until its merger with Cardo Medical, LLC
in September 2008. Since 2003, Dr. Lockshin has been an independent pharmaceutical & life sciences
consultant, focused on small companies that seek to leverage their technology assets inside
healthcare, biotechnology and security sectors. From 1998 to 2002, Dr. Lockshin was a Scientist,
Associate Director, and Director of Discovery Biology & Informatics at Sepracor Inc., where he was
instrumental in establishing the New Leads program, which delivered novel chemical entities into
the preclinical pipeline. In 2002-2003, while Director of Discovery Biology at Beyond Genomics,
Inc., Dr. Lockshin co-developed strategies for utilizing proprietary technology platforms in
clinical trial optimization and prediction of off-target drug activities. Dr. Lockshins current
activities include a business development engagement with TelAztec LCC (Burlington, MA). Since
2004, Dr. Lockshin has served on the Board of Directors of the Ruth K. Broad Biomedical Research
Foundation, a Duke University support corporation, which supports basic research related to
Alzheimers disease and neurodegeneration via intramural, extramural, and international grants. Dr.
Lockshin was a director of Orthodontix, Inc. from July until December 2006. Dr. Lockshin is a
co-inventor on several U.S. patents and applications covering pharmaceuticals, biomaterials, and
optics for remote biochemical sensing. He holds a Bachelors degree in Life Sciences and a PhD in
Biological Chemistry, both from the Massachusetts Institute of Technology.
Lewis J. Shuster, Director
Lewis J. Shuster, age 54, is currently the Chief Executive Officer of Shuster Capital, an
advisor to and angel investor in life science companies with a focus on operating businesses,
including lab reagents, contract services and diagnostics. Mr. Shuster was appointed to serve as a
director of QuikByte effective upon the closing of the Merger. Prior to rejoining Shuster Capital
in November 2007, from June 2003 to November 2007 Mr. Shuster served as the Chief Executive Officer
of Kemia, Inc., a drug discovery and development company, where he led the company to the
completion of $70 million in venture capital financing and Phase I and Phase II clinical trials of
an internally discovered and developed oral anti-inflammatory. From January 2002 to May 2003, Mr.
Shuster founded and served as Chief Executive Officer of Shuster Capital. From February 2000 to
December 2001, Mr. Shuster served in various operating executive positions with Invitrogen
Corporation, including Chief Operating Officer and President of Genomics. Mr. Shuster has also
previously served as the President and Chief Operating Officer, Pharmacopeia Laboratories of
Pharmacopeia, Inc., Chief Financial Officer of Pharmacopeia, Inc., Executive Vice
President, Operations and Finance of Human Genome Sciences, Inc., President and Chief
Executive Officer of Microbiological Associates, Inc. and Vice President, Finance and Chief
Financial Officer of Molecular Design Limited. Mr. Shuster currently serves as a member of the
board of directors and the audit committee chairman of Epitomics, Inc., a monoclonal antibody firm
he helped fund through Shuster Capital in 2002. Mr. Shuster holds an M.B.A from Stanford University
and a B.A. in Economics from Swarthmore College. Mr. Shuster was selected as a director nominee by
Dr. Schuh pursuant to the terms of the Merger Agreement.
Alan Jay Weisberg, Chief Financial and Accounting Officer
Alan Jay Weisberg, age 63, has been our Chief Financial and Accounting Officer since July
2008. Mr. Weisberg served as a director of QuikByte from July 2008 until the closing of the Merger.
Mr. Weisberg served as the Chief Financial Officer and a director of Getting Ready Corporation, a
publicly held shell corporation, from December 2006 until its merger with Winston Laboratories in
September 2008, the Chief Financial Officer and a director of clickNsettle.com, Inc., a publicly
held shell corporation, from October 2007 until its merger with Cardo Medical, LLC in September
2008, and the Chief Financial Officer of Longfoot Communications Corp., a publicly held shell
corporation, from March 2008 until its merger with Kidville Holdings, LLC in August 2008. Mr.
Weisberg was the Acting Chief Financial Officer of Orthodontix, Inc. from September 1999 until
December 2006 and the Treasurer and a director of Orthodontix, Inc. from April 2001 until
Orthodontix merged with Protalix BioTherapeutics, Inc. in December 2006. Since July 1986, Mr.
Weisberg has been a stockholder in the accounting firm of Weisberg Brause & Co., Boca Raton,
Florida. Mr. Weisberg has been the principal financial officer of United Security Corporation, a
broker-dealer registered with FINRA, since June 1987.
32
Item 6. Executive Compensation.
The information required by Item 6 of Form 10 was previously reported by the Company in its
Annual Report on Form 10-K for the fiscal year ended December 31, 2008, filed with the SEC on March
30, 2009, and its Information Statement on Schedule 14f-1/A, filed with the SEC on August 26, 2009.
The foregoing previously reported information is supplemented as follows.
Compensation Discussion and Analysis
The primary goals of our board of directors with respect to executive compensation will be to
attract and retain talented and dedicated executives, to tie annual and long-term cash and stock
incentives to achievement of specified performance objectives, and to create incentives resulting
in increased shareholder value. To achieve these goals, we plan to form a compensation committee to
recommend to our board of directors executive compensation packages, generally comprising a mix of
salary, discretionary bonus and equity awards. Although we have not adopted any formal guidelines
for allocating total compensation between equity compensation and cash compensation, we intend to
implement and maintain compensation plans that tie a substantial portion of our executives overall
compensation to achievement of corporate goals.
Employment Agreements
Effective upon the Merger Closing, we entered into employment letters (the Employment
Letters) with each of Drs. Antonius Schuh and Henry Ji pursuant to which they are employed as our
Chief Executive Officer and Chief Scientific Officer, respectively. Each Employment Letter is for a
term of three years from the Merger Closing (the Term). Under their respective Employment
Letters, Dr. Schuh will receive an annual salary of $250,000, Dr. Ji will receive an annual salary
of $240,000 and each will be eligible to participate in any cash-bonus program and equity award
plan of the Company in such amounts as our board of directors or any applicable committee thereof
shall determine in its sole discretion.
Benchmarking of Cash and Equity Compensation
We have not retained a compensation consultant to review our policies and procedures with
respect to executive compensation. We may retain the services of third-party executive compensation
specialists from time to time in connection with the establishment of cash and equity compensation
and related policies and we intend to take into account input from other independent members of our
board of directors and publicly available data relating to the compensation practices and policies
of other companies within and outside our industry.
Elements of Compensation
We will evaluate individual executive performance with a goal of setting compensation at
levels the board of directors or any applicable committee thereof believes are comparable with
executives in other companies of similar size and stage of development while taking into account
our relative performance and our own strategic goals. Post-Merger, the compensation received by our
executive officers is anticipated to consist of the following elements:
Base Salary. Base salaries for our executives are established based on the scope of their
responsibilities and individual experience, taking into account competitive market compensation
paid by other companies for similar positions within our industry.
Discretionary Annual Bonus. In addition to base salaries, our board of directors or any
applicable committee thereof will have the authority to award discretionary annual bonuses to our
executive officers. The annual incentive bonuses are intended to compensate officers for achieving
corporate goals and value-creating milestones.
Long-Term Incentive Program. We believe that positive long-term performance is achieved
through an ownership culture that encourages such performance through the use of stock and
stock-based awards. We believe that the use of equity and equity-based awards offers the best
approach to achieving our compensation goals. We have not adopted formal stock ownership guidelines
or a formal long-term incentive program.
33
Severance and Change-in-Control Benefits. Each of Dr. Schuhs and Dr. Jis Employment Letter
provides that in the event his employment with us is terminated prior to the end of the Term for
any reason other than for cause, then concurrent with such termination, he will be entitled to
receive (i) all compensation accrued, but unpaid, up to the date of termination, and (ii) severance
in an amount equal to one years then base salary. In addition, the vesting of all stock options or
other equity awards then held by him will accelerate in full and be exercisable for a period of 90
days after any such termination. For each of the Employment Letters, cause is defined to mean (i)
any dishonesty that is intended to materially injure the business of the Company, (ii) conviction
of any felony, or (iii) any wanton or willful dereliction of duties that are not cured after being
provided with 30 days written notice.
Restricted Stock Grants or Awards. We have not granted any restricted stock or restricted
stock awards pursuant to our equity benefit plans to any of our executive officers. However, our
board of directors or any applicable committee thereof, in its discretion, may in the future elect
to make such grants to our executive officers if it deems it advisable.
Other Compensation. We intend to provide benefits and perquisites for our executive officers
at levels comparable to those provided to other executive officers in our industry. Our board of
directors or any applicable committee thereof, in its discretion, may revise, amend or add to the
benefits and perquisites of any executive officer as it deems it advisable and in the best interest
of the Company and our shareholders.
Director Compensation
We are currently considering the precise composition of our director compensation policy. We
may adopt a policy of paying independent directors an annual retainer, stock options and a fee for
attendance at board of directors and committee meetings. We anticipate reimbursing each director
for reasonable travel expenses related to such directors attendance at board of directors and
committee meetings.
On
September 18, 2009, the board of directors of the Company
approved the grant of options
to purchase 40,000 shares of QuikByte Common Stock, to become
effective as of the Merger Closing, at an exercise price of $0.0448 per share, to
each of those persons who, effective as of the closing of the Merger, will serve as a non-employee
director of the Company (each an Option Grant and collectively, the Option Grants), which
persons are Dr. Ernst-Güenter Afting, Dr. S. James Freedman, Mr. Glenn Halpryn, Dr. Curtis Lockshin
and Mr. Lewis J. Shuster (each an Optionee). Each
Option Grant will vest on September 21, 2010,
but, subject to certain exceptions, may not be exercised until
September 21, 2011. Each Option
Grant will terminate on the earlier of (i) the date that the Optionee ceases to
serve as a director of the Company, if he ceases to serve as a
director of the Company prior to September 21, 2010
(ii) September 21, 2019, or (iii) the liquidation of dissolution of the Company. Each Option Grant was made
pursuant to a Stock Option Agreement, the form or which is filed as Exhibit 10.11 hereto and
incorporated herein by reference.
Item 7. Certain Relationships and Related Transactions, and Director Independence.
Transactions with Related Persons
The information required by Item 7 of Form 10 was previously reported by the Company in its
Annual Report on Form 10-K for the fiscal year ended December 31, 2008, filed with the SEC on March
30, 2009, and its Information Statement on Schedule 14f-1/A, filed with the SEC on August 26, 2009.
The foregoing previously reported information is supplemented as follows.
The description of the Merger, the Merger Agreement, the Stock Purchase Agreement, the Option Grants and the
Financing contained in item 2.01 to this Current Report on Form 8-K is incorporated by reference in
this Item 7.
Pursuant to the Stock Purchase Agreement, the Company issued an aggregate of 44,634,374 shares
of QuikByte Common Stock to the Investors for an aggregate offering price of $2.0 million. As part
of this issuance, Halpryn Group VI, LLC, an entity in which Mr. Glenn Halpryn, a director of the
Company and at such time its Chairman, President and Chief Executive Officer, and Mr. Steven Jerry
Glauser, a greater than 5% shareholder of the Company, are members, acquired 17,184,228 shares of
QuikByte Common Stock for $770,000, Mr. Noah M. Silver, at such
time a director and Vice President,
Secretary and Treasurer of the Company, acquired 446,344 shares of QuikByte Common Stock for
$20,000, and Mr. Ronald Stein, at such time a director of the Company, acquired 446,344 shares of
QuikByte Common Stock for $20,000. Also as part of the issuance, Mr. Glenn L. Halpryns father,
Ernest Halpryn, acquired 446,344 shares of QuikByte Common Stock for $20,000, Ms. Alison Levin, Mr.
Glenn L. Halpryns sister, acquired 223,172 shares of QuikByte Common Stock for $10,000, and IVC
Investors, LLLP, an entity which Mr. Glenn L. Halpryn, Ernest Halpryn and Alison Levin have an
interest, acquired 781,102 shares of QuikByte Common Stock for $35,000. In addition, Dr. Henry Ji, who was a greater than 5% shareholder and director of STI prior to the Merger and is a greater
than 5% shareholder and director of the Company subsequent to the Merger, acquired 1,785,375 shares
of QuikByte Common Stock for $80,000, and Dr. Ernst-Guenter Afting, Dr. S. James Freedman and Mr.
Lewis Shuster, each of whom was appointed as a director of the Company in connection with the
Merger,
34
acquired 557,930, 111,586 and 669,516 shares of QuikByte Common Stock for $25,000, $5,000 and
$30,000, respectively.
Review, Approval or Ratification of Transactions with Related Persons
Our board of directors conducts an appropriate review of and oversees all related-party
transactions. We have not yet adopted formal standards in respect of the review and approval or
ratification of related-party transactions; however, our board has conformed to the following
standards: (i) all related-party transactions must be fair and reasonable to the Company and on
terms comparable to those reasonably expected to be agreed to with independent third parties for
the same goods and/or services at the time authorized by the board, and (ii) all related-party
transactions must be authorized, approved or ratified by the affirmative vote of a majority of the
directors who have no interest, either directly or indirectly, in any such related party
transaction.
Director Independence
Our board of directors has determined that (i) Drs. James Freedman, Curtis Lockshin and
Ernst-Güenter Afting and Mr. Lewis Shuster are independent as defined under Rule 5605(a)(2) of
the NASDAQ Marketplace Rules and (ii) Drs. Schuh and Ji and Mr. Halpryn, are not independent
directors under Rule 5605(a)(2) of the NASDAQ Marketplace Rules. Our board of directors has made
the aforementioned determinations notwithstanding that we do not presently have any securities
listed on the NASDAQ or any national securities exchange or inter-dealer quotation system having
requirements that a majority of our board be independent.
|
|
|
Item 8. |
|
Legal Proceedings. |
The Company is subject to various legal proceedings and claims arising in the ordinary course
of business. Our management does not expect that the results of any such proceedings, either
individually or in the aggregate, would have a material adverse effect on our financial position,
results of operations or cash flows.
|
|
|
Item 9. |
|
Market Price of and Dividends on the Registrants Common Equity and Related Stockholder Matters. |
Our common stock is quoted on the OTCBB under the symbol QBSW. Including the 169,375,807
shares of our common stock issued in the Merger and the 44,634,374 shares of our common stock
issued in the Financing, there are currently 225,084,127 shares of common stock outstanding. As of
September 18, 2009, the last bid quoted for our common stock on the OTCBB was $0.12 per share. All
OTCBB quotations reproduced herein reflect inter-dealer prices, without retail mark-up, mark-down
or commission and may not necessarily represent actual transactions.
The following table sets forth the range of high and low bid quotations for the Common Stock,
as reported by the OTCBB, on a quarterly basis for the fiscals years ended December 31, 2008 and
2007 and the interim period ended September 17, 2009.*
For the Fiscal Year Ended on December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
High |
|
|
Low |
|
Quarter Ended March 31, 2007 |
|
$ |
5.40 |
|
|
$ |
0.60 |
|
Quarter Ended June 30, 2007 |
|
|
3.60 |
|
|
|
2.00 |
|
Quarter Ended September 30, 2007 |
|
|
2.00 |
|
|
|
1.10 |
|
Quarter Ended December 31, 2007 |
|
|
2.80 |
|
|
|
1.40 |
|
For the Fiscal Year Ended on December 31, 2008
|
|
|
|
|
|
|
|
|
|
|
High |
|
|
Low |
|
Quarter Ended March 31, 2008 |
|
$ |
1.60 |
|
|
$ |
1.30 |
|
Quarter Ended June 30, 2008 |
|
|
1.30 |
|
|
|
1.00 |
|
Quarter Ended September 30, 2008 |
|
|
1.60 |
|
|
|
0.90 |
|
Quarter Ended December 31, 2008 |
|
|
0.90 |
|
|
|
0.45 |
|
35
For the Interim Period Ended on September 17, 2009
|
|
|
|
|
|
|
|
|
|
|
High |
|
|
Low |
|
Quarter Ended March 31, 2009 |
|
$ |
0.45 |
|
|
$ |
0.10 |
|
Quarter Ended June 30, 2009 |
|
|
0.10 |
|
|
|
0.10 |
|
July 1, 2009 through September 17, 2009 |
|
|
0.21 |
|
|
|
0.10 |
|
|
|
|
* |
|
The Company effectuated a one-for-twenty reverse stock split effective as of March 16, 2007 and a
one-for-ten reverse stock split effective as of October 6, 2008. The prices set forth above have
been adjusted for these reverse stock splits. |
As of the close of business on September 16, 2009, there were approximately 254 holders of
record of our common stock and an undetermined number of beneficial owners.
We paid no cash dividends in respect of our common stock during our two most recent fiscal
years, and we have no plans to pay any dividends or make any other distributions in the foreseeable
future. The payment by us of dividends, if any, in the future, rests within the discretion of the
Board and will depend, among other things, upon our earnings, capital requirements and financial
condition.
Equity Compensation Plan Information
We do not currently have any equity compensation plans under which we would be authorized to
issue our common stock, rights and/or stock options.
|
|
|
Item 10. |
|
Recent Sales of Unregistered Securities |
In the following discussion, all share amounts reflect one-for-twenty reverse stock split
effected as of March 17, 2007 and a one-for-ten reverse stock split effected as of October 6, 2008.
On January 31, 2007, the Company issued 750,000 shares of QuikByte Common Stock to Ponce
Acquisition, LLC, a Colorado limited liability company, for an aggregate offering price of $15,000.
On March 23, 2007, the Company sold to KI Equity Partners V, LLC, a Delaware limited liability
company (KI Equity), 6,000,000 shares of QuikByte Common Stock for an aggregate offering price of
$600,000.
On March 26, 2007, the Company issued 750,000 shares of QuikByte Common Stock to KI Equity for
an aggregate offering price of $75,000. Also on March 26, 2007, the Company issued 160,000 shares
of QuikByte Common Stock to Mr. Kevin R. Keating, who at the time of the issuance was the sole
officer and a director of the Company, for services rendered to the Company valued at $16,000.
In addition, on March 26, 2007, the Company issued 550,000 shares of QuikByte Common Stock to
Garisch Financial, Inc., an Illinois corporation, in consideration of consulting services rendered
to the Company valued at $55,000.
On July 7, 2008, the Company issued an aggregate of 3,143,700 shares of QuikByte Common Stock
to the certain investors for an aggregate offering price of $562,500.
On
September 18, 2009, the Company issued an aggregate of 44,634,374 shares of QuikByte Common
Stock to the Investors for an aggregate offering price of $2,000,000.
The Company issued these shares of QuikByte Common Stock under the exemption from registration
provided by Section 4(2) of the Securities Act and/or Rule 506 of Regulation D promulgated
thereunder.
36
There were no underwriting discounts or commissions for any of the issuances disclosed in this
Item 10.
Item 11. Description of Registrants Securities to be Registered.
The Amended and Restated Articles of Incorporation of the Company (the Articles) authorize
the issuance of 500,000,000 shares of QuikByte Common Stock and 100,000,000 shares of preferred
stock, $0.0001 par value (the Preferred Stock).
Each record holder of QuikByte Common Stock is entitled to one vote for each share held on all
matters properly submitted to the shareholders of the Company for their vote. Cumulative voting for
the election of directors is not permitted by the Articles. The Articles provide that any action to
be taken by the shareholders of the Company which, pursuant to statute, requires the vote of
two-thirds of the outstanding shares entitled to vote thereon, may be acted upon by the vote or
concurrence of the holders of a majority of the outstanding shares of the shares, class or series
entitled to vote thereon.
The holders of outstanding shares of QuikByte Common Stock are entitled to such dividends as
may be declared from time to time by the Board out of legally available funds, subject to
preferential dividend rights, if any, of the holders of Preferred Stock. In the event of
liquidation, dissolution or winding up of the affairs of the Company, the holders of QuikByte
Common Stock are entitled to receive, ratably, the net assets of the Company available to
shareholders after distribution is made to the holders of Preferred Stock, if any, who are given
preferred rights upon liquidation. The holders of outstanding shares of QuikByte Common Stock have
no preemptive, conversion or redemptive rights. All of the issued and outstanding shares of
QuikByte Common Stock are, and all unissued shares when offered and sold will be, fully paid, and
nonassessable. To the extent that additional shares of QuikByte Common Stock are issued, the
relative interests of then existing shareholders may be diluted.
The Articles provide the Board with the authority to determine the designations, powers,
preferences, rights, qualifications, limitations or restrictions of the Preferred Stock, and
establish different series of Preferred Stock and variations in the relative rights and preferences
as between different series thereof in accordance with Colorado law. The holders of any series of
Preferred Stock shall have no voting power whatsoever, except for such voting powers with respect
to the election of directors or other matters as may be stated in the resolutions of the Board
creating any such series of Preferred Stock.
|
|
|
Item 12. |
|
Indemnification of Directors and Officers. |
Article 109 of the Colorado Business Corporation Act (the CBCA) permits the Company to
indemnify any officer, director, employee or agent (any such person, a Proper Person) against
expenses, fines, penalties, settlements or judgments arising in connection with a legal proceeding
to which such person was a party, to the extent that such persons actions were in good faith, were
believed to be in the Companys best interest and were not unlawful. Indemnification is mandatory
with respect to a Proper Person who was wholly successful in defense of a proceeding.
The circumstances under which indemnification is granted in connection with an action brought
on the Companys behalf are generally the same as those mentioned above. However, with respect to
actions against directors or officers, indemnification may be granted only with respect to
reasonable expenses actually incurred in connection with the defense or settlement of the action.
In these actions, the person to be indemnified must have acted in good faith and in a manner the
person reasonably believed was in the Companys best interest; the person must not have been
adjudged liable to the Company; and the person must not have received an improper personal benefit.
The Articles provide that the Company shall indemnify any person who is or was a director of
the Company to the maximum extent provided by Colorado law. The Articles also provide that the
Company shall indemnify any person who is or was an officer, employee or agent of the Company, and
who is not a director of the Company, to the maximum extent provided by law, or to a greater extent
if consistent with law and if provided by resolution of the Companys shareholders or directors, or
in a contract.
37
The Articles authorize the Company to purchase and maintain insurance on behalf of any person
who is or was a director, officer, employee, fiduciary or agent of the Company and who while a
director, officer, employee, fiduciary or agent of the Company, is or was serving at the request of
the Company as a director, officer, partner, trustee, employee, fiduciary or agent of any other
foreign or domestic corporation, partnership, joint venture, trust, other enterprise or employee
benefit plan, against any liability asserted against or incurred by such person in any such
capacity or arising out of such persons status as such, whether or not the corporation would have
the power to indemnify such person against such liability under provisions of Colorado law.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted
to directors, officers or persons controlling the Company pursuant to the foregoing provisions, the
Company has been informed that, in the opinion of the SEC, this indemnification is against public
policy as expressed in the Securities Act and is therefore unenforceable.
This summary of the circumstances in which such indemnification is provided for is qualified
in its entirety by reference to the Articles and the Companys Amended and Restated Bylaws, which
are filed as exhibits hereto and incorporated herein by this reference, and to the relevant
provisions of the CBCA.
|
|
|
Item 13. |
|
Financial Statements and Supplementary Data |
The financial statements included in Item 9.01 of this Current Report on Form 8-K are
incorporated by reference in this Item 13. QuikBytes audited financial statements for its fiscal
years ended December 31, 2008 and 2007 were previously reported by QuikByte in its Annual Report on
Form 10-K for the fiscal year ended December 31, 2008, filed with the SEC on March 30, 2009.
QuikBytes unaudited interim financial statements required by this Item 13 were previously reported
in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed with the SEC on
August 13, 2009.
|
|
|
Item 14. |
|
Changes in and Disagreements With Accountants on Accounting and Financial Disclosures |
We have had no disagreements with our independent and registered public accounting firm on
accounting and financial disclosure.
Item 15. Financial Statements and Exhibits
The disclosures set forth in Item 9.01 of this Current Report on Form 8-K are incorporated by
reference in this Item 15. QuikBytes audited financial statements for its fiscal years ended
December 31, 2008 and 2007 were previously reported by QuikByte in its Annual Report on Form 10-K
for the fiscal year ended December 31, 2008, filed with the SEC on March 30, 2009. QuikBytes
unaudited interim financial statements required by this Item 15 were previously reported in its
Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed with the SEC on August 13,
2009.
*****End of Form 10 Disclosures*****
|
|
|
Item 3.02. |
|
Unregistered Sales of Equity Securities. |
The disclosure set forth in Item 2.01 of this Current Report on Form 8-K, including the Form
10 disclosures, is incorporated by reference in this Item 3.02.
|
|
|
Item. 5.01. |
|
Changes in Control of Registrant. |
The disclosure set forth in Item 2.01 of this Current Report on Form 8-K, including the Form
10 disclosures, is incorporated by reference in this Item 5.01.
To the Companys knowledge, there are no arrangements or understandings among pre-Merger
persons who controlled in excess of 50% of our then issued and outstanding voting securities nor
among those post-Merger persons who control in excess of 50% of our currently issued and
outstanding voting securities. Additionally, to the Companys knowledge, there are no arrangements, including any pledge by any person of
securities of the Company, the operation of which may at a subsequent date result in a change of
control of the Company.
38
|
|
|
Item 5.02. |
|
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
The
disclosure set forth in Item 2.01 of this Current Report on Form 8-K, including the Form 10 disclosures, is incorporated by reference in this Item 5.02.
Effective upon consummation of the Merger: (i) the board increased the number of seats on the
board from five to seven; (ii) Messrs. Noah Silver, Ronald Stein and Alan Jay Weisberg resigned as
directors; and (iii) in accordance with our bylaws, the remaining directors appointed Drs. James
Freedman, Henry Ji, Antonius Schuh, and Ernst-Güenter Afting and Mr. Lewis Shuster to fill the
vacancies created by the resignations and increase in number of seats on our board. Each of the new
directors will hold office until the earlier of the next annual meeting of shareholders and the
election and qualification of their successors or their earlier death, resignation or removal.
Additionally, effective upon consummation of the Merger, Mr. Glenn L. Halpryn resigned as
Chief Executive Officer and President and Mr. Noah Silver resigned as Vice President, Secretary and
Treasurer, and our board of directors appointed the following persons to serve in the offices set
forth across from their names:
|
|
|
Name |
|
Title(s) |
Dr. Antonius Schuh
|
|
Chief Executive Officer |
Dr. Henry Ji.
|
|
Chief Scientific Officer & Secretary |
All officers, whether executive or non-executive, serve at the discretion of our board of
directors.
|
|
|
Item 5.06. |
|
Change in Shell Company Status. |
The disclosure set forth in Item 2.01 to this Current Report on Form 8-K, including the Form
10 disclosures, is incorporated by reference in this Item 5.06. As a result of the completion of
the Merger, we believe we are no longer a shell company as that term is defined in Rule 12b-2 of
the Exchange Act.
|
|
|
Item 9.01. |
|
Financial Statements and Exhibits. |
|
|
|
(a)
|
|
Financial statements of business acquired. |
|
(b)
|
|
Pro forma financial information. |
39
INDEX TO FINANCIAL STATEMENTS
|
|
|
|
|
|
|
Page |
|
(a) Financial Statements of Sorrento Therapeutics, Inc. |
|
|
|
|
|
Financial Statements for the Six Months Ended June 30, 2009 and 2008 |
|
|
|
|
|
|
|
|
F-2 |
|
|
|
|
|
F-3 |
|
|
|
|
|
F-4 |
|
|
|
|
|
F-5 |
|
|
Financial Statements for the Years Ended December 31, 2008 and 2007 |
|
|
|
|
|
|
|
|
F-7 |
|
|
|
|
|
F-8 |
|
|
|
|
|
F-9 |
|
|
|
|
|
F-10 |
|
|
|
|
|
F-11 |
|
|
|
|
|
F-12 |
|
|
(b) Pro Forma Financial Information (Unaudited) |
|
|
|
|
|
|
|
|
F-14 |
|
|
|
|
|
F-15 |
|
|
|
|
|
F-16 |
|
|
|
|
|
F-17 |
|
|
|
|
|
F-18 |
|
F-1
Sorrento Therapeutics, Inc.
(A development stage company)
Balance Sheet
|
|
|
|
|
|
|
|
|
|
|
June 30, 2009 |
|
|
December 31, 2008 |
|
|
|
Unaudited |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
2,297,639 |
|
|
$ |
|
|
Other current assets |
|
|
60,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
2,357,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
2,357,639 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Equity (Deficit) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
182,897 |
|
|
$ |
75,965 |
|
Accounts
payable shareholders |
|
|
40,683 |
|
|
|
40,683 |
|
Income taxes payable |
|
|
1,600 |
|
|
|
800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
225,180 |
|
|
|
117,448 |
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies (Note 5) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity (Deficit) |
|
|
|
|
|
|
|
|
Common stock; no par value; 100,000,000 shares
authorized; 6,646,273 and 4,000,000 shares
issued and outstanding for 2009 and 2008,
respectively |
|
|
2,274,731 |
|
|
|
400 |
|
Shareholder note receivable |
|
|
(30 |
) |
|
|
|
|
Deficit accumulated during the development stage |
|
|
(142,242 |
) |
|
|
(117,848 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders Equity (Deficit) |
|
|
2,132,459 |
|
|
|
(117,448 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,357,639 |
|
|
$ |
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-2
Sorrento Therapeutics, Inc.
(A development stage company)
Unaudited Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
January 25, 2006 |
|
|
|
3 Months Ended |
|
|
3 Months Ended |
|
|
6 Months Ended |
|
|
6 Months Ended |
|
|
(Inception) through |
|
|
|
June 30, 2009 |
|
|
June 30, 2008 |
|
|
June 30, 2009 |
|
|
June 30, 2008 |
|
|
June 30, 2009 |
|
Revenues |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses |
|
|
24,769 |
|
|
|
3,991 |
|
|
|
24,769 |
|
|
|
3,991 |
|
|
|
143,434 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,175 |
|
|
|
|
|
|
|
1,175 |
|
|
|
|
|
|
|
1,175 |
|
Other Income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other Income |
|
|
1,175 |
|
|
|
|
|
|
|
1,175 |
|
|
|
|
|
|
|
3,592 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Before Income Taxes |
|
|
(23,594 |
) |
|
|
(3,991 |
) |
|
|
(23,594 |
) |
|
|
(3,991 |
) |
|
|
(139,842 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
|
|
|
|
|
|
|
|
800 |
|
|
|
800 |
|
|
|
2,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(23,594 |
) |
|
$ |
(3,991 |
) |
|
$ |
(24,394 |
) |
|
$ |
(4,791 |
) |
|
$ |
(142,242 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-3
Sorrento Therapeutics, Inc.
(A development stage company)
Unaudited Statements of Cash Flow
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
January 25, 2006 |
|
|
|
6 Months Ended |
|
|
6 Months Ended |
|
|
(Inception) through |
|
|
|
June 30, 2009 |
|
|
June 30, 2008 |
|
|
June 30, 2009 |
|
Cash Flows From Operating Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(24,394 |
) |
|
$ |
(4,791 |
) |
|
$ |
(142,242 |
) |
Adjustments to reconcile net loss to net cash used in
operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash resulting from changes in: |
|
|
|
|
|
|
|
|
|
|
|
|
Other current assets |
|
|
(60,000 |
) |
|
|
|
|
|
|
(60,000 |
) |
Accounts payable |
|
|
106,932 |
|
|
|
3,991 |
|
|
|
182,897 |
|
Accounts payable-shareholders |
|
|
|
|
|
|
|
|
|
|
40,683 |
|
Income taxes payable |
|
|
800 |
|
|
|
800 |
|
|
|
1,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
23,338 |
|
|
|
|
|
|
|
22,938 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows From Financing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net of issuance costs |
|
|
2,274,301 |
|
|
|
|
|
|
|
2,274,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Increase in Cash |
|
|
2,297,639 |
|
|
|
|
|
|
|
2,297,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash at Beginning of Period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash at End of Period |
|
$ |
2,297,639 |
|
|
$ |
|
|
|
$ |
2,297,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosure of Cash Flow Information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the period for
Income taxes |
|
$ |
|
|
|
$ |
|
|
|
$ |
800 |
|
Non Cash Financing Activities:
During 2009 the Company recorded a receivable from one of its stockholders for $30 related to the issuance of 30,000 shares of
common stock.
During 2006 the Company recorded a receivable from its stockholders for $400 related to the issuance of 4,000,000 shares of common
stock. In 2008 the $400 receivable was offset by $400 in accounts payable to stockholders.
The accompanying notes are an integral part of these financial statements.
F-4
Sorrento Therapeutics, Inc.
(A development stage company)
NOTES TO FINANCIAL STATEMENTS
(unaudited)
|
|
|
|
|
1.
|
|
Summary of
Significant
Accounting
Policies
|
|
A summary of the Companys
significant accounting policies
consistently applied in the
preparation of the accompanying
financial statements follows. |
|
|
|
|
|
|
|
Organization
|
|
Sorrento Therapeutics, Inc. (the
Company) was incorporated in the
state of California as San Diego
Antibody Company, Inc. in January
2006. In February 2009, the name of
the Company was changed to Sorrento
Therapeutics, Inc. The Company is
engaged in the business of
developing and commercializing a
broad, generally applicable
platform for the generation of
fully human monoclonal antibodies
based on its proprietary
technology. |
|
|
|
|
|
|
|
Use of
estimates
|
|
The preparation of the financial
statements in conformity with U.S.
generally accepted accounting
principles requires management to
make estimates and assumptions that
affect certain reported amounts and
disclosures. Accordingly, actual
results could differ from those
estimates. |
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
The Company considers all highly
liquid investments with original
maturities of 90 days or less to be
cash equivalents. |
|
|
|
|
|
|
|
Income taxes
|
|
Deferred income taxes are
recognized for the tax consequences
in future years of differences
between the tax basis of assets and
liabilities and their financial
reporting amounts at each year end
based on enacted tax laws and
statutory tax rates applicable to
the periods in which the
differences are expected to affect
taxable income. Valuation
allowances are established when
necessary to reduce deferred tax
assets to the amount expected to be
realized. Income tax expense is the
combination of the tax payable for
the year and the change during the
year in deferred tax assets and
liabilities. From the Companys
inception through June 2009, the
tax provision consisted of the
annual California state income tax
of $800. |
|
|
|
|
|
|
|
|
|
As of June 30, 2009, a non-current
deferred tax asset of approximately
$57,000 had been recognized for the
temporary differences related to
federal and state net operating
losses. A valuation allowance has
been recorded to fully offset the
deferred tax asset as it is not
more likely than not that the
assets will be fully utilized. The
valuation allowance at June 30,
2009 is approximately $57,000, an
increase of $10,000 from December
31, 2008. |
|
|
|
|
|
|
|
|
|
At June 30, 2009, the Company had
unused federal and state net
operating losses of approximately
$140,000. |
|
|
|
|
|
2.
|
|
Development
Stage
Operations
|
|
The Company is in the development
stage and activities since the
Companys inception through June
2009 were devoted primarily to
developing proprietary platform
technology for the generation of
fully human monoclonal antibodies
and obtaining financing. |
|
|
|
|
|
3.
|
|
Common
Stock
|
|
On March 1, 2009, the Company issued 290,526 shares
of restricted common stock to consultants for $0.001
per share under the 2009 Equity Incentive Plan. In
March 2009, the Company issued 40,000 shares of
common stock outside of the Plan to consultants for
a purchase price of $0.001 per share. |
F-5
Sorrento Therapeutics, Inc.
(A development stage company)
NOTES TO FINANCIAL STATEMENTS
(unaudited)
|
|
|
|
|
|
|
|
|
On June 10, 2009, the Company issued 2,315,747
shares of common stock to OPKO Health, Inc, in
exchange for $2,300,000 in cash proceeds. The
Company incurred approximately $26,000 of financing
costs which have been offset against the proceeds
received. |
|
|
|
|
|
4.
|
|
Related Party
Transactions
|
|
From inception through June 30, 2009, the
stockholders of the Company incurred expenses on
behalf of the Company. At June 30, 2009 and 2008,
the Company had accounts payable due to the
stockholders related to these expenses of
approximately $41,000 and $44,000, respectively. |
|
|
|
|
|
5.
|
|
Commitments
and
Contingencies |
|
|
|
|
|
|
|
|
|
Litigation
|
|
In the normal course of business, the Company is
occasionally named as a defendant in various
lawsuits. Management is currently not aware of any
pending lawsuits. |
|
|
|
|
|
|
|
License
agreement
|
|
In connection with the stock purchase agreement with
OPKO, Inc. (see Note 3), the Company entered into a
license agreement allowing OPKO an exclusive license
to use the Companys patent rights relating to the
manufacture of human antibody libraries. The license
agreement also provides the Company with an
exclusive, royalty-free license to use certain of
OPKOs patents to develop, use, and make selected
products. |
|
|
|
|
|
6.
|
|
Subsequent
Events
|
|
In July 2009, Sorrento Therapeutics, Inc., a
Delaware corporation, was formed, with the
California corporation as its sole shareholder.
Subsequently, the California corporation merged into
the Delaware corporation, and upon merger, each
share of the California corporations stock was
converted into a share of the Delaware corporations
stock. The common stock of the Delaware corporation
that was held by the California corporation was then
cancelled. |
|
|
|
|
|
|
|
|
|
In July 2009, the Company signed a plan of merger
agreement with QuikByte Software Inc., a
publicly-traded company with no active operations.
Under the agreement, the Company will become a
wholly owned subsidiary of QuikByte Software. After
the merger is completed, QuikByte Software will be
renamed to integrate the Sorrento Therapeutics, Inc.
brand and will be headquartered in San Diego,
California. |
|
|
|
|
|
|
|
|
|
In July 2009, the Company entered into an operating
lease agreement for its office facility in
California. The lease has an initial five year term
commencing on September 1, 2009. Total future
minimum lease payments required over the lease term
are approximately $440,000. |
F-6
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Independent Auditors Report
To the Board of Directors and Stockholders of
Sorrento Therapeutics, Inc.
San Diego, California
We have audited the accompanying balance sheets of Sorrento Therapeutics, Inc. (the Company) as
of December 31, 2008 and 2007, and the related statements of operations, stockholders deficit,
and cash flows for the years then ended and for the period from January 25, 2006 (Inception)
through December 31, 2008. These financial statements are the responsibility of the Companys
management. Our responsibility is to express an opinion on these financial statements based on
our audits.
We conducted our audits in accordance with the Public Company Accounting Oversight Board (United
States). Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over
financial reporting. Our audit included consideration of internal control over financial
reporting as a basis for designing audit procedures that are appropriate in the circumstances,
but not for the purpose of expressing an opinion on the effectiveness of the Companys internal
control over financial reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in the financial
statements, assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation. We believe that
our 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 Sorrento Therapeutics, Inc. as of December 31, 2008 and 2007,
and the results of its operations and its cash flows for the years then ended and for the period
from January 25, 2006 (Inception) through December 31, 2008, in conformity with accounting
principles generally accepted in the United States of America.
/s/ Mayer Hoffman McCann P.C.
San Diego, CA
August 18, 2009
F-7
Sorrento Therapeutics, Inc.
(A development stage company)
Balance Sheet
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Assets |
|
|
|
|
|
|
|
|
Accounts
receivable stockholders |
|
$ |
|
|
|
$ |
400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
$ |
|
|
|
|
400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
|
|
|
$ |
400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
75,965 |
|
|
$ |
48,603 |
|
Accounts
payable stockholders |
|
|
40,683 |
|
|
|
43,500 |
|
Income taxes payable |
|
|
800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
117,448 |
|
|
|
92,103 |
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies (Note 4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Deficit |
|
|
|
|
|
|
|
|
Common stock; no par value; 100,000,000 shares
authorized; 4,000,000 shares issued and
outstanding at both 2008 and 2007 |
|
|
400 |
|
|
|
400 |
|
Deficit accumulated during the development stage |
|
|
(117,848 |
) |
|
|
(92,103 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders deficit |
|
|
(117,448 |
) |
|
|
(91,703 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
400 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-8
Sorrento Therapeutics, Inc.
(A development stage company)
Statements of Operations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
January 25, 2006 |
|
|
|
Year Ended |
|
|
Year Ended |
|
|
(Inception) through |
|
|
|
December 31, 2008 |
|
|
December 31, 2007 |
|
|
December 31, 2008 |
|
Revenues |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative expenses |
|
|
27,362 |
|
|
|
15,502 |
|
|
|
118,665 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from Operations |
|
|
(27,362 |
) |
|
|
(15,502 |
) |
|
|
(118,665 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income |
|
|
2,417 |
|
|
|
|
|
|
|
2,417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Before Income Taxes |
|
|
(24,945 |
) |
|
|
(15,502 |
) |
|
|
(116,248 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
800 |
|
|
|
800 |
|
|
|
1,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(25,745 |
) |
|
$ |
(16,302 |
) |
|
$ |
(117,848 |
) |
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-9
Sorrento Therapeutics, Inc.
(A development stage company)
Statements of Stockholders Deficit
Period from January 25, 2006 (Inception) through December 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the |
|
|
|
|
|
|
Common Stock |
|
|
Development |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Stage |
|
|
Total |
|
Balance at Inception |
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock Issued to Founders |
|
|
4,000,000 |
|
|
|
400 |
|
|
|
|
|
|
|
400 |
|
Net Loss |
|
|
|
|
|
|
|
|
|
|
(75,801 |
) |
|
|
(75,801 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
4,000,000 |
|
|
|
400 |
|
|
|
(75,801 |
) |
|
|
(75,401 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
|
|
|
|
|
|
|
|
|
(16,302 |
) |
|
|
(16,302 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
4,000,000 |
|
|
|
400 |
|
|
|
(92,103 |
) |
|
|
(91,703 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
|
|
|
|
|
|
|
|
|
(25,745 |
) |
|
|
(25,745 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
4,000,000 |
|
|
$ |
400 |
|
|
$ |
(117,848 |
) |
|
$ |
(117,448 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
F-10
Sorrento Therapeutics, Inc.
(A development stage company)
Statements of Cash Flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
January 25, 2006 |
|
|
|
|
|
|
|
|
|
|
|
(Inception) |
|
|
|
Year Ended |
|
|
Year Ended |
|
|
through |
|
|
|
December 31, |
|
|
December 31, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
Cash Flows From Operating Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(25,745 |
) |
|
$ |
(16,302 |
) |
|
$ |
(117,848 |
) |
Adjustments to reconcile net loss to net cash
provided by (used in) operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash resulting from changes in: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
27,362 |
|
|
|
13,760 |
|
|
|
75,965 |
|
Accounts payable-stockholders |
|
|
(2,417 |
) |
|
|
2,542 |
|
|
|
41,083 |
|
Income taxes payable |
|
|
800 |
|
|
|
|
|
|
|
800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Change in Cash |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash at Beginning of Period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash at End of Period |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosure of Cash Flow Information: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the period for: |
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
$ |
|
|
|
$ |
800 |
|
|
$ |
800 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non Cash Financing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
During 2006 the Company recorded a receivable from one of its stockholders for $400 related to the issuance of 4,000,000
shares of common stock. In 2008 the $400 receivable was offset in accounts payable to stockholders.
The accompanying notes are an integral part of these financial statements.
F-11
Sorrento Therapeutics, Inc.
(A development stage company)
NOTES TO FINANCIAL STATEMENTS
|
|
|
|
|
1.
|
|
Summary of
Significant
Accounting
Policies
|
|
A summary of the Companys significant accounting
policies consistently applied in the preparation of
the accompanying financial statements follows. |
|
|
|
|
|
|
|
Organization
|
|
Sorrento Therapeutics, Inc. (the Company) was
incorporated in the state of California as San Diego
Antibody Company, Inc. in January 2006. In February
2009, the name of the Company was changed to
Sorrento Therapeutics, Inc. The Company is engaged
in the business of developing and commercializing a
broad, generally applicable platform for the
generation of fully human monoclonal antibodies
based on its proprietary technology. |
|
|
|
|
|
|
|
Use of
estimates
|
|
The preparation of the financial statements in
conformity with U.S. generally accepted accounting
principles requires management to make estimates and
assumptions that affect certain reported amounts and
disclosures. Accordingly, actual results could
differ from those estimates. |
|
|
|
|
|
|
|
Income taxes
|
|
Deferred income taxes are recognized for the tax
consequences in future years of differences between
the tax basis of assets and liabilities and their
financial reporting amounts at each year end based
on enacted tax laws and statutory tax rates
applicable to the periods in which the differences
are expected to affect taxable income. Valuation
allowances are established when necessary to reduce
deferred tax assets to the amount expected to be
realized. Income tax expense is the combination of
the tax payable for the year and the change during
the year in deferred tax assets and liabilities.
From the Companys inception through 2008, the tax
provision consisted of the annual California state
income tax of $800. |
|
|
|
|
|
|
|
|
|
As of December 31, 2008, a non-current deferred tax
asset of approximately $47,000 had been recognized
for the temporary differences related to federal and
state net operating losses. A valuation allowance
has been recorded to fully offset the deferred tax
asset as it is not more likely than not that the
assets will be fully utilized. The valuation
allowance at December 31, 2008 is approximately
$47,000. |
|
|
|
|
|
|
|
|
|
At December 31, 2008, the Company had unused federal
and state net operating losses of approximately
$117,000. |
|
|
|
|
|
2.
|
|
Development
Stage
Operations
|
|
The Company is in the development stage and
activities since the Companys inception through
2008 were devoted primarily to developing
proprietary platform technology for the generation
of fully human monoclonal antibodies. |
|
|
|
|
|
3.
|
|
Related Party
Transactions
|
|
From inception through December 31, 2008, the
stockholders of the Company incurred expenses on
behalf of the Company. At December 31, 2008 and
2007, the Company had accounts payable due to the
stockholders related to these expenses of
approximately $41,000 and $44,000, respectively. |
|
|
|
|
|
4.
|
|
Commitments
and
Contingencies |
|
|
|
|
|
|
|
|
|
Litigation
|
|
In the normal course of business, the Company is
occasionally named as a defendant in various
lawsuits. Management is currently not aware of any
pending lawsuits. |
F-12
Sorrento Therapeutics, Inc.
(A development stage company)
NOTES TO FINANCIAL STATEMENTS
|
|
|
|
|
5.
|
|
Subsequent
Events
|
|
During February 2009, the Company changed its name
from San Diego Antibody Company, Inc. to Sorrento
Therapeutics, Inc. In July 2009, Sorrento
Therapeutics, Inc., a Delaware corporation, was
formed, with the California corporation as its sole
shareholder. Subsequently, the California
corporation merged into the Delaware corporation,
and upon merger, each share of the California
corporations stock was converted into a share of
the Delaware corporations stock. The common stock
of the Delaware corporation that was held by the
California corporation was then cancelled. |
|
|
|
|
|
|
|
|
|
In February 2009 the Company adopted the 2009 Equity
Incentive Plan (the Plan). The terms of the Plan
provide for the grant of incentive stock options,
nonstatutory stock options, restricted stock awards,
and stock bonuses to employees, directors, and
consultants of the Company. On March 1, 2009, the
Company issued 290,526 shares of restricted common
stock to consultants for $0.001 per share under the
Plan. |
|
|
|
|
|
|
|
|
|
In March 2009 the Company issued 40,000 shares of
common stock outside of the Plan to consultants for
a purchase price of $0.001 per share. |
|
|
|
|
|
|
|
|
|
On June 10, 2009, the Company issued 2,315,747
shares of common stock to OPKO Health, Inc.
(OPKO), in exchange for $2,300,000 in cash
proceeds. In connection with the stock purchase
agreement, the Company entered into a license
agreement allowing OPKO an exclusive license to use
the Companys patent rights relating to the
manufacture of human antibody libraries. The license
agreement also provides the Company with an
exclusive, royalty-free license to use certain of
OPKOs patents to develop, use, and make selected
products. |
|
|
|
|
|
|
|
|
|
In July 2009, the Company signed a plan of merger
agreement with QuikByte Software Inc., a
publicly-traded company with no active operations.
Under the agreement, the Company will become a
wholly owned subsidiary of QuikByte Software. After
the merger is completed, QuikByte Software will be
renamed to integrate the Sorrento Therapeutics, Inc.
brand and will be headquartered in San Diego,
California. |
|
|
|
|
|
|
|
|
|
In July 2009, the Company entered into an operating
lease agreement for its office facility in
California. The lease has an initial five year term
commencing on September 1, 2009. Total future
minimum lease payments required over the lease term
are approximately $440,000. |
F-13
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL STATEMENTS
The following unaudited pro forma condensed combined balance sheet combines the consolidated
historical balance sheet of QuikByte Software, Inc. and the historical balance sheet of Sorrento
Therapeutics, Inc. as of June 30, 2009 giving effect to the merger of Sorrento Merger Corp., Inc.,
a wholly-owned subsidiary of QuikByte Software, Inc., and Sorrento Therapeutics, Inc. pursuant to
the merger agreement, as if the merger had been consummated on June 30, 2009. The following
unaudited pro forma condensed combined statements of operations combine the historical statements
of operations of QuikByte Software, Inc. and Sorrento Therapeutics, Inc. for the period ended June
30, 2009 and the year ended December 31, 2008, giving effect to the merger, as if it had occurred
on January 1, 2008.
We are providing the following information to aid you in your analysis of the financial aspects of
the merger. We derived this information for the year ended December 31, 2008 from the audited
financial statements of QuikByte Software, Inc. and Sorrento Therapeutics, Inc. We derived the
information regarding 2009 from the unaudited financial statements of QuikByte Software, Inc. and
Sorrento Therapeutics, Inc. for that period. Neither QuikByte Software, Inc. nor Sorrento
Therapeutics, Inc. assumes any responsibility for the accuracy or completeness of the information
provided by the other party. This information should be read together with the QuikByte Software,
Inc. audited and unaudited financial statements and related notes as filed in annual and quarterly
reports with the Securities and Exchange Commission and the Sorrento Therapeutics, Inc. audited and
unaudited financial statements included in this document under Sorrento Therapeutics, Inc.
The historical financial information has been adjusted to give effect to pro forma events that are
directly attributable to the merger, factually supportable, and expected to have a continuing
impact on the combined results.
The unaudited pro forma consolidated information is for illustrative purposes only. The financial
results may have been different had the companies always been combined. Because the plans for these
activities have not been finalized, we are not able to reasonably quantify the cost of such
activities. You should not rely on the pro forma combined financial information as being indicative
of the historical results that would have been achieved had the companies always been combined or
the future results that the combined company will experience.
The following information should be read in conjunction with the pro forma condensed combined
financial statements:
|
|
|
Accompanying notes to the unaudited pro forma combined condensed financial statements |
|
|
|
|
Separate historical financial statements of QuikByte Software, Inc. for the period ended
June 30, 2009 and the year ended December 31, 2008 as filed with the SEC in their Annual
and Quarterly Reports |
|
|
|
|
Separate historical financial statements of Sorrento Therapeutics, Inc. for the period
ended June 30, 2009 and the year ended December 31, 2008 included elsewhere in this
document |
The unaudited pro forma condensed combined financial statements are presented for informational
purposes only. The pro forma information is not necessarily indicative of what the financial
position or results of operations actually would have been had the merger been completed at the
dates indicated. In addition, the unaudited pro forma condensed combined financial statements do
not purport to project the future financial position or operating results of the combined company.
The unaudited pro forma condensed financial statements were prepared using the reverse acquisition
application of the equity recapitalization method of accounting with Sorrento Therapeutics, Inc.
treated as the acquirer in accordance with U.S. generally accepted accounting principles for
accounting and financial reporting purposes. Accordingly, the assets and liabilities of QuikByte
Software, Inc. have been presented at their historical cost with no goodwill or other intangible
assets recorded and no increment in stockholders equity.
F-14
UNAUDITED PRO FORMA CONDENSED
COMBINED BALANCE SHEET
OF
SORRENTO THERAPEUTICS, INC. AND QUIKBYTE SOFTWARE, INC.
JUNE 30, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical |
|
|
|
|
|
|
|
|
|
|
|
|
|
Sorrento |
|
|
QuikByte |
|
|
Pro Forma |
|
|
|
|
|
|
Combined Pro |
|
|
|
Therapeutics, Inc. |
|
|
Software, Inc. |
|
|
Adjustments |
|
|
|
|
|
|
Forma |
|
| |
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
2,297,639 |
|
|
$ |
291,674 |
|
|
$ |
2,000,000 |
|
|
|
a |
|
|
$ |
4,589,313 |
|
Prepaid expenses |
|
|
|
|
|
|
510 |
|
|
|
|
|
|
|
|
|
|
|
510 |
|
Other current assets |
|
|
60,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
60,000 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
2,357,639 |
|
|
|
292,184 |
|
|
|
|
|
|
|
|
|
|
|
4,649,823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
2,357,639 |
|
|
$ |
292,184 |
|
|
|
|
|
|
|
|
|
|
$ |
4,649,823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders Equity (Deficit) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
182,897 |
|
|
|
38,008 |
|
|
|
|
|
|
|
|
|
|
|
220,905 |
|
Accounts
payable - shareholders |
|
|
40,683 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40,683 |
|
Income taxes payable |
|
|
1,600 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,600 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
225,180 |
|
|
|
38,008 |
|
|
|
|
|
|
|
|
|
|
|
263,188 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
225,180 |
|
|
|
38,008 |
|
|
|
|
|
|
|
|
|
|
|
263,188 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock |
|
|
2,274,731 |
|
|
|
1,107 |
|
|
|
44,634 |
|
|
|
a |
|
|
|
62,354 |
|
|
|
|
|
|
|
|
|
|
|
|
(2,268,085 |
) |
|
|
b |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,967 |
|
|
|
c |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional paid-in-capital |
|
|
|
|
|
|
2,053,769 |
|
|
|
1,955,366 |
|
|
|
a |
|
|
|
4,466,553 |
|
|
|
|
|
|
|
|
|
|
|
|
2,268,085 |
|
|
|
b |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,967 |
) |
|
|
c |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,800,700 |
) |
|
|
d |
|
|
|
|
|
Shareholder note receivable |
|
|
(30 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(30 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated deficit |
|
|
(142,242 |
) |
|
|
(1,800,700 |
) |
|
|
1,800,700 |
|
|
|
d |
|
|
|
(142,242 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders Equity |
|
|
2,132,459 |
|
|
|
254,176 |
|
|
|
|
|
|
|
|
|
|
|
4,386,635 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,357,639 |
|
|
$ |
292,184 |
|
|
|
|
|
|
|
|
|
|
$ |
4,649,823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-15
UNAUDITED PRO FORMA CONDENSED
COMBINED STATEMENT OF OPERATIONS
OF
SORRENTO THERAPEUTICS, INC. AND QUIKBYTE SOFTWARE, INC.
FOR THE 6 MONTHS ENDED JUNE 30, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical |
|
|
|
|
|
|
|
|
|
Sorrento |
|
|
QuikByte |
|
|
Pro Forma |
|
|
|
|
|
|
Therapeutics, Inc. |
|
|
Software, Inc. |
|
|
Adjustments |
|
|
Combined Pro Forma |
|
|
|
|
Revenues |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Professional fees |
|
|
|
|
|
|
109,830 |
|
|
|
|
|
|
|
109,830 |
|
General and administrative expenses |
|
|
24,769 |
|
|
|
28,784 |
|
|
|
|
|
|
|
53,553 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from Operations |
|
|
(24,769 |
) |
|
|
(138,614 |
) |
|
|
|
|
|
|
(163,383 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,175 |
|
|
|
598 |
|
|
|
|
|
|
|
1,773 |
|
Other Income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other Income |
|
|
1,175 |
|
|
|
598 |
|
|
|
|
|
|
|
1,773 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Before Income Taxes |
|
|
(23,594 |
) |
|
|
(138,016 |
) |
|
|
|
|
|
|
(161,610 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision |
|
|
800 |
|
|
|
|
|
|
|
|
|
|
|
800 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(24,394 |
) |
|
$ |
(138,016 |
) |
|
$ |
|
|
|
$ |
(162,410 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss per share basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(0.00 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma
shares used to compute net loss per share basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
225,084,127 |
|
F-16
UNAUDITED PRO FORMA CONDENSED
COMBINED STATEMENT OF OPERATIONS
OF
SORRENTO THERAPEUTICS, INC. AND QUIKBYTE SOFTWARE, INC.
FOR THE YEAR ENDED DECEMBER 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical |
|
|
|
|
|
|
|
|
|
Sorrento Therapeutics, |
|
|
QuikByte |
|
|
Pro Forma |
|
|
|
|
|
|
Inc. |
|
|
Software, Inc. |
|
|
Adjustments |
|
|
Combined Pro Forma |
|
|
|
|
Revenues |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Professional fees |
|
|
|
|
|
|
156,658 |
|
|
|
|
|
|
|
156,658 |
|
General and administrative expenses |
|
|
27,362 |
|
|
|
33,857 |
|
|
|
|
|
|
|
61,219 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from Operations |
|
|
(27,362 |
) |
|
|
(190,515 |
) |
|
|
|
|
|
|
(217,877 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
|
|
1,613 |
|
|
|
|
|
|
|
1,613 |
|
Other Income |
|
|
2,417 |
|
|
|
|
|
|
|
|
|
|
|
2,417 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Other Income |
|
|
2,417 |
|
|
|
1,613 |
|
|
|
|
|
|
|
4,030 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Before Income Taxes |
|
|
(24,945 |
) |
|
|
(188,902 |
) |
|
|
|
|
|
|
(213,847 |
) |
|
Income tax provision |
|
|
800 |
|
|
|
|
|
|
|
|
|
|
|
800 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(25,745 |
) |
|
$ |
(188,902 |
) |
|
$ |
|
|
|
$ |
(214,647 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss per share basic and
diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(0.00 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma shares used to compute net loss
per share basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
225,084,127 |
|
F-17
NOTES TO UNAUDITED PRO FORMA
CONDENSED COMBINED FINANCIAL STATEMENTS
1. Basis of Presentation
On July 14, 2009, QuikByte Software, Inc. and Sorrento Therapeutics, Inc entered into a definitive
agreement under which Sorrento Merger Corp. will be merged into Sorrento Therapeutics, Inc. in a
transaction to be accounted for as a reverse acquisition of QuikByte Software, Inc. As a result,
the historical financial statements of Sorrento Therapeutics, Inc. constitute the historical
financial statements of the merged companies. The transaction is considered to be a capital
transaction and as such is the equivalent to the issuance of common stock by Sorrento Therapeutics,
Inc. for the net monetary assets of QuikByte Software, Inc., accompanied by a re-capitalization.
For accounting purposes, Sorrento Therapeutics is treated as the continuing reporting entity. The
costs of the transaction incurred by Sorrento Therapeutics will be charged directly to equity,
those incurred by QuikByte will be expensed.
2. Pro Forma Adjustments
There were no inter-company balances and transactions between QuikByte Software and Sorrento
Therapeutics as of the dates and for the periods of these pro forma condensed combined financial
statements.
The pro forma combined provision for income taxes does not necessarily reflect the amounts that
would have resulted had QuikByte Software and Sorrento Therapeutics filed consolidated income tax
returns during the periods presented. The pro forma adjustments included in the unaudited pro forma
condensed combined financial statements are as follows:
|
a) |
|
To record the $2,000,000 proceeds for the sale of common stock by QuikByte Software in
accordance with the merger agreement. |
|
|
b) |
|
Common stock adjustment to reflect the change in par value from no par value to $0.001
for the Sorrento Therapeutic shares outstanding. |
|
|
c) |
|
Common stock adjustment to reflect the change in par value from $0.0001 to $0.001 for
the QuikByte Software shares outstanding. |
|
|
d) |
|
The elimination of the QuikByte Software, Inc. accumulated deficit. |
3. Pro Forma Net Loss Per Share
The pro forma basic and diluted net loss per share are based on the number of QuikByte common
stock shares outstanding, including the shares purchased by investors in conjunction with the
merger agreement plus the common stock shares issued to Sorrento Therapeutics based on the
conversion ratio in the merger agreement.
F-18
(d) Exhibits
|
|
|
Exhibit Number |
|
Description |
2.1*
|
|
Merger Agreement, dated July 14, 2009, by and among
QuikByte Software, Inc., Sorrento Therapeutics, Inc.,
Sorrento Merger Corp., Inc., the Stockholders Agent
and the Parent Representative, filed as Exhibit 2.1 to
our Current Report on Form 8-K filed with the SEC on
July 14, 2009 and incorporated by reference herein. |
|
|
|
2.2
|
|
First Amendment to Merger Agreement, dated August 26,
2009, by and among QuikByte Software, Inc., Sorrento
Therapeutics, Inc., Sorrento Merger Corp., Inc., the
Stockholders Agent and the Parent Representative,
filed as Exhibit 2.2 to our Current Report on Form 8-K
filed with the SEC on August 26, 2009 and incorporated
by reference herein. |
|
|
|
3.1
|
|
Amended and Restated Articles of Incorporation of the
Company, filed as Exhibit 3.1 to our Quarterly Report
on Form 10-Q filed with the SEC on November 13, 2008
and incorporated by reference herein. |
|
|
|
3.2
|
|
Amended and Restated Bylaws of the Company, filed as
Exhibit 3.2 to our Current Report on Form 8-K filed
with the SEC on July 7, 2008 and incorporated by
reference herein. |
|
|
|
9.1
|
|
Form of Stockholder Voting Agreement by and among
QuikByte Software, Inc. and the Stockholder of Sorrento
Therapeutics, Inc. set forth on the signature page
thereto, dated as of July 14, 2009, filed as Exhibit 9.1 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.1
|
|
Form of Stock Purchase Agreement, dated September 18,
2009, by and among QuikByte Software, Inc. and the
Investors listed on Exhibit A thereto, filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.2
|
|
Form of Lockup Agreement, filed as Exhibit 10.2 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.3
|
|
Escrow Agreement, dated September 21, 2009, by and
among QuikByte Software, Inc., the Stockholders Agent,
the Parent Representative and Bank of America, N.A. |
|
|
|
10.4 ±
|
|
Employment Letter, dated
September 18, 2009, between
QuikByte Software, Inc. and Dr. Antonius Schuh, filed as Exhibit 10.4 to our Current Report on Form 8-K filed with the SEC on September 21, 2009 and incorporated by reference herein. |
|
|
|
10.5 ±
|
|
Employment Letter, dated
September 18, 2009, between
QuikByte Software, Inc. and Dr. Henry Ji, filed as Exhibit 10.5 to our Current Report on Form 8-K filed with the SEC on September 21, 2009 and incorporated by reference herein. |
|
|
|
10.6
|
|
Standard Multi-Tenant Office Lease-Net, dated July 28,
2008, by and between Sorrento Therapeutics, Inc. and
Suntree Garden, LLC, filed as Exhibit 10.6 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.7
|
|
First Amendment to Lease, dated August 18, 2009, by and
between Sorrento Therapeutics, Inc. and Suntree Garden,
LLC, filed as Exhibit 10.7 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.8
|
|
Share Purchase Agreement, dated June 10, 2009, between
Sorrento Therapeutics, Inc. and OPKO Health, Inc., filed as Exhibit 10.8 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.9
|
|
Limited License Agreement, dated June 10, 2009, between
Sorrento Therapeutics, Inc. and OPKO Health, Inc., filed as Exhibit 10.9 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.10++
|
|
Patent Assignment Agreement, dated June 10, 2009,
between Henry H. Ji and Sorrento Therapeutics, Inc., filed as Exhibit 10.10 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.11
|
|
Form of Stock Option Agreement. |
|
|
|
Exhibit Number |
|
Description |
21.1
|
|
Subsidiary of QuikByte Software, Inc., filed as Exhibit 21.1 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
99.1
|
|
Press Release, dated September 18, 2009, filed as Exhibit 99.1 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
* |
|
Non-material schedules and exhibits have been omitted pursuant to Item 601(b)(2) of
Regulation S-K. The Company hereby undertakes to furnish supplementally copies of any of the
omitted schedules and exhibits upon request by the SEC. |
|
++ |
|
Confidential treatment has been requested with respect to certain portions of this
exhibit. Omitted portions have been filed separately with the SEC.
|
|
± |
|
Management contract or compensatory plan. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
QUIKBYTE SOFTWARE, INC.
|
|
Date: September 21, 2009 |
By: |
/s/ Antonius Schuh, Ph.D. |
|
|
|
Name: |
Antonius Schuh, Ph.D. |
|
|
|
Title: |
Chief Executive Officer |
|
|
EXHIBIT INDEX
|
|
|
Exhibit Number |
|
Description |
2.1*
|
|
Merger Agreement, dated July 14, 2009, by and among
QuikByte Software, Inc., Sorrento Therapeutics, Inc.,
Sorrento Merger Corp., Inc., the Stockholders Agent
and the Parent Representative, filed as Exhibit 2.1 to
our Current Report on Form 8-K filed with the SEC on
July 14, 2009 and incorporated by reference herein. |
|
|
|
2.2
|
|
First Amendment to Merger Agreement, dated August 26,
2009, by and among QuikByte Software, Inc., Sorrento
Therapeutics, Inc., Sorrento Merger Corp., Inc., the
Stockholders Agent and the Parent Representative,
filed as Exhibit 2.2 to our Current Report on Form 8-K
filed with the SEC on August 26, 2009 and incorporated
by reference herein. |
|
|
|
3.1
|
|
Amended and Restated Articles of Incorporation of the
Company, filed as Exhibit 3.1 to our Quarterly Report
on Form 10-Q filed with the SEC on November 13, 2008
and incorporated by reference herein. |
|
|
|
3.2
|
|
Amended and Restated Bylaws of the Company, filed as
Exhibit 3.2 to our Current Report on Form 8-K filed
with the SEC on July 7, 2008 and incorporated by
reference herein. |
|
|
|
9.1
|
|
Form of Stockholder Voting Agreement by and among
QuikByte Software, Inc. and the Stockholder of Sorrento
Therapeutics, Inc. set forth on the signature page
thereto, dated as of July 14, 2009, filed as Exhibit 9.1 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.1
|
|
Form of Stock Purchase Agreement, dated September 18,
2009, by and among QuikByte Software, Inc. and the
Investors listed on Exhibit A thereto, filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.2
|
|
Form of Lockup Agreement, filed as Exhibit 10.2 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.3
|
|
Escrow Agreement, dated September 21, 2009, by and
among QuikByte Software, Inc., the Stockholders Agent,
the Parent Representative and Bank of America, N.A. |
|
|
|
10.4 ±
|
|
Employment Letter, dated
September 18, 2009, between
QuikByte Software, Inc. and Dr. Antonius Schuh, filed as Exhibit 10.4 to our Current Report on Form 8-K filed with the SEC on September 21, 2009 and incorporated by reference herein. |
|
|
|
10.5 ±
|
|
Employment Letter, dated
September 18, 2009, between
QuikByte Software, Inc. and Dr. Henry Ji, filed as Exhibit 10.5 to our Current Report on Form 8-K filed with the SEC on September 21, 2009 and incorporated by reference herein. |
|
|
|
10.6
|
|
Standard Multi-Tenant Office Lease-Net, dated July 28,
2008, by and between Sorrento Therapeutics, Inc. and
Suntree Garden, LLC, filed as Exhibit 10.6 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.7
|
|
First Amendment to Lease, dated August 18, 2009, by and
between Sorrento Therapeutics, Inc. and Suntree Garden,
LLC, filed as Exhibit 10.7 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.8
|
|
Share Purchase Agreement, dated June 10, 2009, between
Sorrento Therapeutics, Inc. and OPKO Health, Inc., filed as Exhibit 10.8 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
10.9
|
|
Limited License Agreement, dated June 10, 2009, between
Sorrento Therapeutics, Inc. and OPKO Health, Inc., filed as Exhibit 10.9 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
Exhibit Number |
|
Description |
10.10++
|
|
Patent Assignment Agreement, dated June 10, 2009,
between Henry H. Ji and Sorrento Therapeutics, Inc., filed as Exhibit 10.10 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein.
|
|
|
|
10.11
|
|
Form of Stock Option Agreement. |
|
|
|
21.1
|
|
Subsidiary of QuikByte Software, Inc., filed as Exhibit 21.1 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
99.1
|
|
Press Release, dated September 18, 2009, filed as Exhibit 99.1 to our Current Report on Form 8-K filed with the SEC on
September 21, 2009 and incorporated by reference herein. |
|
|
|
* |
|
Non-material schedules and exhibits have been omitted pursuant to Item 601(b)(2) of
Regulation S-K. The Company hereby undertakes to furnish supplementally copies of any of the
omitted schedules and exhibits upon request by the SEC. |
|
++ |
|
Confidential treatment has been requested with respect to certain portions of this
exhibit. Omitted portions have been filed separately with the
SEC. |
|
± |
|
Management contract or compensatory plan. |