Company Overview
| Company Name |
CANCER GENETICS, INC |
| Company Address |
201 ROUTE 17 NORTH 2ND FLOOR RUTHERFORD, NJ 07070 |
| Company Phone |
201.528.9200 |
| Company Website |
www.cancergenetics.com |
| CEO |
Panna L. Sharma |
| Employees (as of 12/31/2012) |
49 |
| State of Inc |
-- |
| Fiscal Year End |
12/31 |
| Status |
Priced (4/5/2013) |
| Proposed Symbol |
CGIX |
| Exchange |
OTCBB |
| Share Price |
$10.00 |
| Shares Offered |
600,000 |
| Offer Amount |
$6,000,000.00 |
| Total Expenses |
$2,449,000.00 |
| Shares Over Alloted |
0 |
| Shareholder Shares Offered |
-- |
| Shares Outstanding |
4,200,717 |
| Lockup Period (days) |
180 |
| Lockup Expiration |
10/2/2013 |
| Quiet Period Expiration |
5/15/2013 |
| CIK |
0001349929 |
We estimate that we will receive net proceeds of approximately $3.1 million from
the sale of shares of common stock offered in this offering, or approximately
$4.0 million if the underwriters exercise their over-allotment option in full,
and after deducting the estimated underwriting discounts and commissions and
estimated offering expenses. Of the estimated offering expenses, we already paid
approximately $1.4 million and therefore will have approximately $1.4 million of
additional net proceeds from this offering available to us.
We currently intend to use the net proceeds of the offering as follows:
. $2.0 million to fund our initial contribution to our joint venture with Mayo
(assuming we negotiate an extension of the Mayo agreement); and
. the balance to fund ongoing operations and expansion of the business,
including but not limited to further research and development, and hiring
additional sales and marketing personnel and support increased sales and
marketing activities.
The expected use of net proceeds of this offering represents our current
intentions based upon our present plan and business conditions. As of the date
of this prospectus, we cannot specify with certainty all of the particular uses
for the net proceeds to be received upon the completion of this offering. For
example, if we identify opportunities that we believe are in the best interests
of our stockholders, we may use a portion of the net proceeds from this offering
to acquire, invest in or license complementary products, technologies or
businesses although we have no current commitments, understandings or agreements
to do so. We will have broad discretion in the application of the net proceeds,
and investors will be relying on our judgment regarding the application of the
proceeds of this offering. The actual amounts and timing of our actual
expenditures depend on numerous factors, including the success of our efforts
to market MatBA®-CLL, MatBA®-SLL and MatBA®-DLCBL, to obtain regulatory
approval to sell MatBA®-CLL, MatBA®-SLL and MatBA®-DLCBL outside our clinical
laboratory, the timing and progress of our discovery, research and development
activities for the tests in our pipeline, the success of our efforts to increase
sales of our laboratory services, the success of our efforts to expand our
international sales, our ability to continue to reduce manufacturing costs by
leveraging operations in low cost countries, changes in regulatory requirements
for LDTs, and other unforeseen regulatory or compliance costs. The costs and
timing of test discovery and development activities, particularly conducting
clinical validation studies and obtaining regulatory clearance or approval, are
highly uncertain, subject to substantial risks and can often change. Depending
on the outcome of these activities, our plans and priorities may change and we
may apply the net proceeds of this offering differently than we currently
anticipate. For example, if our joint venture with Mayo does not close, we will
not be required to make an initial $2.0 million capital contribution, or if once
formed the joint venture fails to achieve certain operational milestones, we may
not be required to make additional capital contributions.
As of December 31, 2012, an aggregate of $3.0 million in principal remained
outstanding under the DAM credit facility. Effective January 1, 2012, the DAM
debt bears interest at an annual rate of 10.0%, payable in equal monthly
installments. On February 13, 2013, DAM agreed to convert $1.0 million of the
outstanding principal due to DAM to common stock at the initial offering price
per share upon consummation of this offering. The DAM debt is due on August 15,
2013.
As of December 31, 2012, we had an aggregate of $6.0 million outstanding
pursuant to a Credit Agreement dated December 21, 2011, as amended and restated
as of February 13, 2012 with John Pappajohn, a member of our board of directors
and a stockholder, Dr. Pecora (indirectly through an investment company), a
member of our board of directors, and NNJCA Capital, LLC, a limited liability
company of which Dr. Pecora is a member. The $6.0 million loan bears an annual
interest rate equal to the prime rate plus 6.25% (9.50% at December 31, 2012)
and matures in twelve months, with an option at our election, if there has been
no event of default, to extend the loan term for an additional six months. The
term loan is due on August 15, 2013 (except as with respect to amounts due to
Mr. Pappajohn, as described below). On February 13, 2013, NNJCA agreed to
convert $500,000 of the outstanding principal due to it to common stock at the
initial offering price per share upon consummation of this offering. Mr.
Pappajohn will convert $2.0 million of the indebtedness due to him, and on
February 13, 2013 he agreed to convert the remaining $2.0 million due to his
spouse pursuant to the December 2011 Credit Agreement, to common stock at the
initial offering price per share upon consummation of this offering. We
requested the conversion discussed in this and the preceding paragraph to
assist the Company in meeting Nasdaq’s initial listing standard for
stockholders’ equity and in response to market feedback regarding retaining
capital in the Company after this offering (although we subsequently have
determined that we are not eligible to list on Nasdaq at this time). We used a
portion of the net proceeds from this financing to pay approximately $1.4
million in expenses incurred in connection with our initial public offering.
As a provider of genomic-based tests and services that provide personalized
diagnostic and prognostic information for hematological, urogenital and
HPV-associated cancers, we rely extensively on our ability to combine research
insights with high-quality, state-of-the art clinical laboratory testing. We
believe that we compete principally on the basis of:
. our ability to address complex cancers that are currently difficult to
prognose and challenging to predict treatment outcomes using currently
available technologies;
. the ability of our proprietary tests and services to provide more information
than existing tests with respect to the cancers we address;
. our ability to utilize a wide variety of sample types, accelerating the
time-frame for clinical validation of our tests and allowing health care
providers to readily integrate our tests into their established workflow;
. our ability to perform clinical studies using FFPE samples to either validate
or develop novel insights for our proprietary programs;
. the quality of our services and our ability to collaborate with our customers
on a consultative basis;
. our research and clinical collaborations with key academic and clinical study
groups;
. the quality of our clinical reference laboratory, which enables consistent,
comprehensive and reproducible results;
. the level of disease specific knowledge and customer service we provide, both
to academic centers and community based health care professionals; and
. our workplace environment, recognized by being named #20 nationwide by The
Scientist in “Best Places to Work Industry, 2011”, which increases our
ability to attract both clinical and research talent.
We believe that we compete favorably with respect to these factors, although we
cannot assure you that we will be able to continue to do so in the future or
that new products or tests that perform better than our proprietary tests and
services will be introduced. We believe that our continued success depends on
our ability to:
. expand and enhance our MatBA® tests to provide clinically meaningful
information in additional indications;
. continue to innovate and maintain scientifically advanced technology;
. successfully market and sell our proprietary tests in the United States;
. continue to obtain appropriate regulatory approvals in the United States and
abroad;
. continue to validate our pipeline of microarray tests and DNA probes;
. continue to obtain positive reimbursement decisions from payors and from CMS;
. continue to enter into partnerships with local distributors and/or
manufacturers to expand into emerging markets, including India, Mexico and
Brazil;
. maintain existing and enter into new research and clinical collaborations
with key academic and clinical study groups;
. continue to attract and retain skilled scientific and clinical personnel;
. obtain patents or other protection for our proprietary tests and services;
and
. obtain and maintain our clinical reference laboratory accreditations and
licenses.
Our principal competition comes from existing mainstream diagnostic methods that
pathologists and oncologists use and have used for many years. It may be
difficult to change the methods or behavior of the referring pathologists and
oncologists to incorporate our molecular diagnostic testing in their practices.
In addition, companies offering capital equipment and kits or reagents to local
pathology laboratories represent another source of potential competition. These
kits are used directly by the pathologist, which can facilitate adoption.
We also face competition from companies that offer products or have conducted
research to profile genes, gene expression or protein biomarkers in various
cancers. In particular, Quest Diagnostics and CombiMatrix Corporation market
arrays which are competitive to our MatBA®-CLL and MatBA®-SLL arrays.
Personalized genetic diagnostics is a new area of science, and we cannot
predict what tests others will develop that may compete with or provide results
superior to the results we are able to achieve with the tests we develop. Our
competitors include public companies such as CombiMatrix Corporation, Quest
Diagnostics, Abbott Laboratories, Inc., Johnson & Johnson, Roche Molecular
Systems, Inc., bioTheranostics, Inc. (part of the bioMérieux SA), Genomic
Health, Inc., Myriad Genetics, Inc., Qiagen N.V. and Response Genetics, Inc.
and many private companies, including Agendia B.V. and Foundation Medicine, Inc.
We expect that pharmaceutical and biopharmaceutical companies will increasingly
focus attention and resources on the personalized diagnostic sector as the
potential and prevalence increases of molecularly targeted oncology therapies
approved by FDA along with companion diagnostics. For example, FDA has recently
approved two such agents—Xalkori crizotinib from Pfizer Inc. along with its
companion anaplastic lymphoma kinase FISH test from Abbott Laboratories, Inc.
and Zelboraf vemurafenib from Genentech USA Incorporated and Daiichi-Sankyo Inc.
along with its companion B-RAF kinase V600 mutation test from Roche Molecular
Systems, Inc. These two recent FDA approvals are only the second and third
instances ever of simultaneous approvals of a drug and companion diagnostic,
the first being the 1998 approval of Genentech, Inc.’s Herceptin trastuzumab
for HER2 positive breast cancer along with the HercepTest from partner Dako A/S.
Our competitors may invent and commercialize technology platforms or tests that
compete with ours.
With respect to our clinical laboratory services business we face competition
from companies such as Genoptix, Inc. (a Novartis AG company), Clarient, Inc. (a
division of GE Healthcare, a unit of General Electric Company), Bio-Reference
Laboratories, Inc. and Genzyme Genetics (a LabCorp Specialty Testing Group).
Additionally, projects related to cancer genomics have received increased
government funding, both in the United States and internationally. As more
information regarding cancer genomics becomes available to the public, we
anticipate that more products aimed at identifying targeted treatment options
will be developed and that these products may compete with ours. In addition,
competitors may develop their own versions of our tests in countries where we
did not apply for patents or where our patents have not issued and compete with
us in those countries, including encouraging the use of their test by physicians
or patients in other countries.
Company Description
We are an early-stage diagnostics company focused on developing and
commercializing proprietary genomic tests and services to improve and
personalize the diagnosis, prognosis and response to treatment (theranosis) of
cancer. The proprietary tests we are developing target cancers that are
difficult
to prognose and predict treatment outcomes by using currently
available mainstream techniques. These cancers include hematological, urogenital
and HPV-associated cancers. We recently have begun to provide our proprietary
tests and services along with a comprehensive range of non-proprietary
oncology-focused tests and laboratory services that we have provided
historically to oncologists and pathologists at hospitals, cancer centers, and
physician offices, as well as to biopharmaceutical companies and clinical
research organizations for their clinical trials. We are currently offering our
tests and laboratory services in our 17,936 square foot state-of-the-art
laboratory located in Rutherford, New Jersey, which has been accredited under
the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) to perform high
complexity testing.
Our proprietary tests are based principally on our expertise in specific cancer
types, test development methodologies and proprietary algorithms correlating
genetic events with disease specific information. During the first quarter of
2011, we received CLIA approval for, and commercially launched, MatBA®-CLL,
our first proprietary microarray test for chronic lymphocytic leukemia (“CLL”)
for use in our CLIA-accredited clinical laboratory. In January 2012, we received
CLIA approval for MatBA®-SLL, our proprietary microarray for risk stratification
in small lymphocytic lymphoma (“SLL”), and we are currently offering MatBA®-SLL
in our laboratory. In February 2013, we received CLIA approval for MatBA®-DLBCL,
our proprietary microarray for diagnosis, prognosis and patient monitoring in
diffuse large B cell lymphoma (“DLBCL”). In addition, we are developing a series
of other proprietary genomic tests in our core oncology markets.
We have established collaborative relationships with key thought leaders in
oncology, which enable us to develop and validate the effectiveness and utility
of our tests in a clinical setting and which provide us access to clinically
robust patient data. For example, we agreed to form a joint venture in March
2013 (or such later date that we may negotiate with Mayo) with Mayo Foundation
for Medical Education and Research (“Mayo”) focused on developing oncology
diagnostic services and tests utilizing next-generation sequencing.
Additionally, we agreed to a research collaboration with Memorial
Sloan-Kettering Cancer Center and the Cleveland Clinic to validate our
renal-cancer microarray UroGenRA TM Renal.
We believe that we can be successful by offering cancer professionals a
fully-integrated menu of oncology-focused proprietary and non-proprietary tests
and customized laboratory services. Based on our discussions with leading
researchers in the oncology field and our interactions with our collaborators,
as well as information we learn through performing the nonproprietary genetic
diagnostic testing services which are focused on the specific oncology
categories where we are developing our proprietary tests, we provide to our
customers, we believe that our proprietary tests provide superior diagnostic
and prognostic values than currently available tests and services. We believe
our ability to rapidly translate research insights about the genetics and
molecular mechanisms of cancer into the clinical setting will improve patient
treatment and management and that this approach will become a key component in
the standard of care for personalized cancer treatment.
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We maintain our principal executive offices at 201 Route 17 North, 2nd Floor,
Rutherford, New Jersey 07070. Our telephone number is (201) 528-9200 and our
website address is www.cancergenetics.com.