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Share Name | Share Symbol | Market | Type |
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Cancer Genetics Inc | NASDAQ:CGIX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 4.61 | 4.56 | 4.63 | 0 | 01:00:00 |
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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04-3462475
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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Title of each class
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Name of each exchange on which registered
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Common Stock, $0.0001 par value per share
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NASDAQ Capital Market
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Large accelerated filer
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¨
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Accelerated filer
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Non-accelerated filer
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¨
(do not check if a smaller reporting company)
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Smaller reporting company
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ý
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Class
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Number of Shares
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Common Stock, $.0001 par value
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18,935,594
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PART I
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1.
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1A.
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1B.
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2.
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3.
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4.
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PART II
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5.
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6.
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7.
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7A.
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8.
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9.
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9A.
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9B.
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PART III
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10.
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11.
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12.
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13.
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14.
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PART IV
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15.
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16.
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our ability to achieve profitability by increasing sales of our laboratory tests and services and to continually develop and commercialize novel and innovative diagnostic tests and services for cancer patients;
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our ability to raise additional capital to meet our liquidity needs;
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our ability to clinically validate our pipeline of genomic microarray tests currently in development;
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our ability to execute on our marketing and sales strategy for our genomic tests and gain acceptance of our tests in the market;
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our ability to develop new tests and keep pace with rapidly advancing market and scientific developments;
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our ability to satisfy U.S. (including FDA) and international regulatory requirements with respect to our tests and services, many of which are new and still evolving;
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our ability to obtain reimbursement from governmental and other third-party payors for our tests and services;
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competition from clinical laboratory services companies, diagnostic tests currently available or new tests that may emerge;
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our ability to maintain our clinical collaborations and enter into new collaboration agreements with highly regarded organizations in the cancer field so that, among other things, we have access to thought leaders in the field and to a robust number of samples to validate our tests;
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our reliance on a limited number of customers and our ability to maintain our present customer base and obtain new customers;
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potential product liability or intellectual property infringement claims;
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our reliance on a limited number of suppliers for components for our tests;
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our dependency on third-party manufacturers to supply or manufacture our tests;
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our ability to attract and retain a sufficient number of scientists, clinicians, sales personnel and other key personnel with extensive experience in oncology, who are in short supply;
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our ability to obtain or maintain patents or other appropriate protection for the intellectual property in our proprietary tests and services;
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our dependency on the intellectual property licensed to us or possessed by third parties;
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our ability to expand our relationships with leading distributors and medical facilities in emerging markets;
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our ability to adequately support future growth.
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Item 1.
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Business.
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Customer Category
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Types of Customers
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Nature of Services
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Clinical Services
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• Hospitals
• Cancer Centers
• Clinics
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Clinical services provide information on diagnosis, prognosis and predicting treatment outcomes (theranosis) of cancers to guide patient management.
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Biopharma Services
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• Pharmaceutical and Biotech companies performing clinical trials
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Biopharma services provide companies with customized solutions for patient stratification and treatment selection through an extensive suite of molecular- and biomarker-based testing services, customized assay development and trial design consultation.
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Discovery Services
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• Pharmaceutical and Biotech companies
• Academic Institutions
• Government-Sponsored Research Institutions
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Discovery services provide the tools and testing methods for companies and researchers seeking to identify new molecular-based biomarkers for disease.
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Cancer Type
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Estimated New Cases For 2016
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Estimated Deaths For 2016
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Breast............................
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249,260
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40,890
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Cervical.........................
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12,990
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4,120
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Colorectal......................
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134,490
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49,190
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Endometrial...................
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60,050
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10,470
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Kidney...........................
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62,700
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14,240
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Leukemia......................
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60,140
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24,400
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Lung..............................
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224,390
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158,080
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Melanoma.....................
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76,380
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10,130
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Multiple Myeloma........
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28,170
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11,500
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Non-Hodgkin's Lymphomas...................
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72,580
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20,150
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Ovarian.........................
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22,280
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14,240
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Pancreatic......................
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53,070
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41,780
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Prostate.........................
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180,890
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26,120
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Biotechnology companies;
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Pharmaceutical companies;
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Cancer centers;
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Community hospitals; and
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Research centers
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•
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Leverage our specialized, disease-focused genomic knowledge, insights and proprietary portfolio to secure additional collaborations or partnerships with leading biotech and pharmaceutical companies and clinical research organizations.
Oncology drugs have the potential to be among the most personalized of therapeutics, and yet oncology trials have one of the worst approval success rates. In an effort to improve the outcome of these trials, and more rapidly advance targeted therapeutics, the biotechnology and pharmaceutical community is increasingly looking to companies like us that have both proprietary disease insights and comprehensive testing services as they move toward biomarker-based therapeutics. We believe our comprehensive, disease-focused testing portfolio, which covers 9 of the 10 most prevalent solid and hematological cancers positions us to help the biotech and pharmaceutical community with clinical trials and companion diagnostic development in areas of our core expertise.
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Leverage our expanded clinical sales force and our relationships with global central laboratories to expand our customer base.
We believe that our joint clinical sales force is among the largest oncology-focused clinical sales groups in the molecular diagnostics field.
By leveraging our clinical and biopharma sales force in the United States, along with our relationships with international central laboratories and clinical research organizations, we are able to target our sales and marketing efforts to meet the needs of an expanding and diverse customer segment. In mid-2015 and 2016, we entered into a strategic alliance with the laboratory services group of ICON plc, and with BARC Global Central Laboratory, a division of Cerba HealthCare, each a global contract research organization
(“
CRO
”)
, which we are leveraging to expand our biopharma customer base.
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C
ontinue our focus on translational oncology and drive innovation and cost efficiency in diagnostics by continuing to develop next generation sequencing offerings independently and through our joint venture with Mayo Clinic.
Translational oncology refers to our focus on bringing novel research insights that characterize cancer at the genomic level directly and rapidly into the clinical setting with the overall goal of improving value to patients and providers in the treatment and management of disease. We believe that continuing to develop our existing platforms and next generation sequencing panels will enable significant growth and efficiencies within our business. We will continue to develop next generation sequencing panels independently as well as leverage our joint venture with Mayo Clinic to advance this diagnostic technology.
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Work with health care providers and payors to demonstrate the value of our testing in providing cost efficient and accountable care.
We seek to increase market access by entering into contracts with key payors, cost management organizations and insurance providers and to secure additional coverage for FHACT®, TOO® and Focus::NGS® panels.
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Continue to aggressively manage our cost structure.
We are focused on aggressively managing our operating costs while continuing to seek additional revenue growth opportunities. We are implementing measures to streamline costs across our laboratory facilities, including integrating administrative functions across our US and India operations and implementing key financial enterprise resource planning and human resource systems that enable greater efficiency.
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Over 400 genotyping assays including drug metabolizing enzymes, transporters and receptors.
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Over 19 validated gene expression assays.
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Testing for the FDA's Pharmacogenomic (PGx) Biomarkers in Drug Labels recommended panel.
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Loss of heterozygosity and copy number detection assays.
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Test
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Targeted Cancers
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Technology & Advantages
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Focus::NGS®
Focus::CLL™
Focus::Myeloid™
Focus::Lymphoma™
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• Chronic Lymphocytic Leukemia (CLL)
• Myeloid Cancers
- Myelodysplastic Syndromes (MDS)
- Acute Myeloid Leukemia (AML)
- Myeloproliferative Neoplasms (MPN)
• B-Cell Lymphomas
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Focus::NGS
TM
is our family of next generation sequencing tests developed for the analysis of genomic alterations to determine, guide and inform diagnosis, prognosis and theranosis of particular hematological cancers and solid tumors.
• Next generation sequencing performs massively parallel sequencing, which is able to detect biomarker mutations and aberrations that are present at very low levels and which may be missed by other, less sensitive methodologies.
• Our proprietary Focus::CLL™ panel is the only NGS test for CLL that assesses 7 genes in a single test, providing clinically relevant data for prognosis, disease management and treatment selection, and is available both for routine clinical patient diagnosis and management, as well as for patient stratification in clinical trials for CLL or SLL.
• Our proprietary Focus::Myeloid™ panel is designed to target 54 genes, and we believe it will provide important prognostic information for myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), as well as diagnostic and prognostic information for myeloproliferative neoplasms (MPN)
• Our proprietary Focus::Lymphoma™ panel enables the targeted sequencing of 220 genes and has the ability to customize reporting that provides clinically actionable information to determine treatment options for patients with various forms of B-Cell Lymphomas.
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Test
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Targeted Cancers
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Technology & Advantages
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FHACT®
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• HPV-Associated Cancers
- Cervical Cancer
- Anal Cancer
- Head & Neck Cancers
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FHACT® is our proprietary, 4-color FISH-based DNA probe designed to identify aberrations in four important chromosomal regions that have been implicated in cancers associated with infection by the human papilloma virus (HPV): cervical, anal and oropharyngeal.
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FHACT
®
is designed to determine copy number changes of four particular genomic regions by fluorescent
in situ
hybridization (FISH). These regions of DNA give specific information about the progression from HPV infection to cervical cancer, in particular the stage and subtype of disease.
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FHACT
®
is designed to enable earlier detection of abnormal cells and can identify the additional genomic
biomarkers that allow for the prediction of cancer progression.
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FHACT
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is designed to leverage the same Pap smear sample taken from the patient during routine screening, thus reducing the burden on the patient while delivering greater information to the clinician.
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We currently offer an application of FHACT® as an LDT for cervical cancer and are developing applications for additional cancer targets.
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We have obtained CE marking for FHACT®, which allows us to market the test in the European Economic Area.
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Test
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Targeted Cancers
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Technology & Advantages
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Tissue of Origin®
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• Solid Tissue Cancers
- Thyroid
- Breast
- Non-Small Cell Lung Cancer (NSCLC)
- Gastric
- Pancreas
- Colorectal
- Liver
- Bladder
- Kidney
- Non-Hodgkin’s Lymphoma
- Melanoma
- Ovarian
- Sarcoma
- Testicular Germ Cell
- Prostate
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• Tissue of Origin® (TOO®) is FDA-cleared, Medicare-approved, and provides extensive analytical and clinical validation for statistically significant improvement in accuracy over other methods.
• TOO® is a gene expression test that is used to identify the origin in cancer cases that are metastatic and/or poorly differentiated and unable to be typed by traditional testing methods.
• TOO® increases diagnostic accuracy and confidence in site-specific treatment decisions, and leads to a change in patient treatment based on results 65% of the time it is used.
• TOO® assesses 2,000 genes, covering 15 of the most common tumor types and 90% of all solid tumors.
• In the fourth quarter of 2015, we acquired the TOO® test through our acquisition of substantially all of the assets of Response Genetics, Inc.
• TOO® is FDA-cleared, Medicare-reimbursed, and provides extensive analytical and clinical validation for statistically significant improvement in accuracy over other methods.
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Focus::Oncomine™
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• Solid Tissue Cancers
- Lung
- Colorectal
- Melanoma
- Breast
- Bladder
- Thyroid
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Focus::Oncomine™
is one test in our family of next generation sequencing tests developed for the analysis of genomic alterations to determine, guide and inform diagnosis, prognosis and theranosis of solid tumors.
• Next generation sequencing performs massively parallel sequencing, which is able to detect biomarker mutations and aberrations that are present at very low levels and which may be missed by other, less sensitive methodologies.
• Focus::Oncomine™ is designed to cover hotspot mutations of 35 unique genes in various different types of solid tumors, allowing for the detection of 989 hotspot variants, including single nucleotide variants (SNVs), with a very low input DNA material.
• Focus::Oncomine™ is designed to detect hotspot mutations that have clinical utility in prognosis or diagnosis or therapeutic implications in various solid tumors.
• The biomarkers included in Focus::Oncomine™ were selected based on information in the Oncomine Knowledgebase, which compiles genomic information from clinical trials, and were confirmed with industry-leading pharmaceutical partners. The results of the assay should be interpreted in the context of available clinical, pathologic, and laboratory information.
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Focus::Renal™
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• Kidney
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Focus::Renal™, a highly-sensitive NGS panel, detects mutations of 76 renal cancer-related genes, as well as genome-wide copy number changes, and critical single nucleotide variants (SNVs), all in a single test, that enable precision diagnosis, prognosis, and therapy selection for renal cancer patients.
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Focus::Renal™ is the only NGS panel to simultaneously detect genome-wide copy number changes, SNP genotypes along with mutations in 76 renal cancer-related genes, covering relevant drug pathways.
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Focus::Renal™ can be performed on a wide variety of patient specimen types, such as needle biopsies, fine-needle aspirates, and resected specimens using both formalin-fixed paraffin-embedded (FFPE) and fresh/fresh-frozen specimens, including the ones with minimal starting material.
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Focus::Renal™ was developed by CGI in collaboration with leading cancer centers and academic institutions, including MSKCC, Cleveland Clinic, Huntsman Cancer Center at University of Utah, and University Hospital of Paris.
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UroGenRA®
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• Kidney
- Clear Cell Renal Cell Carcinoma (ccRCC)
- Chromophobe Renal Cell Carcinoma (chrRCC)
- Papillary Renal Carcinoma (pRCC)
- Oncocytoma (OC)
• Prostate
• Bladder
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UroGenRA® has 101 regions of the human genome represented, and these regions can be used for gain/loss evaluation in urogenital neoplasms including kidney, prostate and bladder.
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UroGenRA®-Kidney Array-CGH provides genomic diagnostic information to assist routine histology in the subtyping of ccRCC, chrRCC and OC from either core needle biopsies or resected specimens.
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UroGenRA®-Kidney assesses 16 genomic regions that have diagnostic significance in the four main renal cortical neoplasm subtypes.
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UroGenRA®-Kidney can use DNA from either core needle biopsies or resected specimens, provided as fresh frozen tissue.
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Result from UroGenRA®-Kidney are analyzed using our proprietary algorithm KidneyPath™ to classify specimens as normal, undetermined, or into one of the four main renal cortical neoplasm subtypes.
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Test
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Targeted Cancers
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Technology & Advantages
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Focus::HERSite™
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• Breast
• Ovarian
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•
Focus::HERSite™
is one test in our family of next generation sequencing tests developed for the analysis of genomic alterations to determine, guide and inform diagnosis, prognosis and theranosis of some of the most prevalent hereditary cancers.
• Next generation sequencing performs massively parallel sequencing, which is able to detect biomarker mutations and aberrations that are present at very low levels and which may be missed by other, less sensitive methodologies.
• Focus::HERSite™ analyzes the 16 most common genes associated with breast and ovarian cancers and provide comprehensive coverage of the BRCA1 and BRCA2 genes.
• Focus::HERSite™ sequences 16 genes associated with an increased lifetime risk of cancer in a single reaction.
• Mutations in these genes are typically single nucleotide variants (SNVs) and small insertions or deletions, and like BRCA 1/2, the increased cancer risk is inherited in an autosomal dominant manner, meaning that one inherited gene is sufficient to cause disease.
• Sequencing these genes in a given patient increases the clinical sensitivity for overall increase in breast and ovarian cancer risk.
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United States
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Clinical Sales
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Collaborate with leading research universities and institutions that enable the validation of our new tests.
Work with community-based cancer centers that need a reliable and collaborative partner for cancer testing.
Build relationships with individual thought leaders in oncology, hematology and pathology to deliver services that provide value to their patients.
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Biopharma Sales
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Collaborate with scientific development teams at pharmaceutical companies on studies involving translational medicine and genotyping.
Build relationships in the research and development segment to identify partners with a need for biomarker discovery studies.
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India
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Clinical Sales
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Develop relationships with oncologists, corporate hospitals and reference labs, as well as with physicians in local clinics.
Engage the population of oncology patients in India, where a majority of oncology drugs are paid for out-of-pocket.
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Biopharma & Discovery Sales
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Work with academic and research institutions for validation of our tests in the Indian population.
Collaborate with scientific development teams at biotech and pharmaceutical companies and government agencies on studies involving tests and services.
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China
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Biopharma Sales
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Leverage US-based companies conducting clinical trials with a component of those trials occurring in China.
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Collaborating Institution
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Principle Investigator(s)
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Focus of Collaboration
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North Shore-Long Island Jewish Health System,
New York
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Dr. Kanti Rai
Dr. Nicholas Chiorazzi
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Clinical validation of biomarkers and signatures for CLL diagnosis and therapeutic response
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Memorial Sloan-Kettering Cancer Center,
New York
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Dr. Jeremy Durack
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Evaluation of FISH-based and CHG-array tests
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National Cancer Institute,
Maryland
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Dr. Nicolas Wentzensen
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Evaluation of FHACT®
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Kamineni Hospital,
Hyderabad, India
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Dr. Annie Hassan
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Evaluation of FHACT®
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Columbia University,
New York
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Dr. Azra Raza
Dr. Siddhartha Mukherjee
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Identification of genomic biomarkers for myeloid cancers
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Apollo Hospitals,
India
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Evaluation of FHACT®
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Keck Medicine of University of Southern California,
California
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Dr. Imran Siddiqi
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Identification and evaluation of genomic biomarkers for lymphomas and other B cell malignancies
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University of Southern California,
California
, & HTG Molecular,
Arizona
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Dr. Pamela Ward
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MicroRNA whole transcription assay validation
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University of Southern California,
California
, & HTG Molecular,
Arizona
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Dr. Heinz-Josef Lenz and Dr. Yu Sunakawa
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Gene expression analysis using an immuno-oncology panel for measurement of response to immune therapy
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Groupe Hospitalier Pitié Salpétriere,
Paris
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Analyze the variability of genomic alterations in renal cancer
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Huntsman Cancer Center Institute, University of Utah,
Utah
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Dr. Neeraj Agarwal
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Evaluation of biomarkers for kidney cancer diagnosis and therapeutic response and liquid biopsy assay development
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Huntsman Cancer Center Institute, University of Utah,
Utah
and Pfizer
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Validation of biomarkers to predict Stutent response and liquid biopsy assay development
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Moffitt Cancer Center,
Florida
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Dr. Anna Giuliano
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Evaluation of FHACT® for oral cancer
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University of Virginia School of Medicine, Virginia, & HTG Molecular,
Arizona
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Evaluation of genomic signatures in immune response
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Yale University
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Dr. Brian Shuch
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Evaluation of biomarkers in NGS Focus::Renal™ to stratify and monitor patients
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•
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Hematological cancers. We have two U.S. patents (U.S. Patent Nos. 8,580,713 and 8,557,747), as well as patents in the EU, India and Canada directed to MatBA®, a microarray for detecting (and distinguishing) particular types of mature B cell neoplasms present in typical non-Hodgkin’s lymphoma, Hodgkin’s lymphoma and chronic lymphocytic leukemia. These patents and foreign application cover our trademarked MatBA® microarray and are directed to both the microarray itself as well as associated methodologies designed to detect the particular type of mature B cell neoplasm present in a patient. These patents and foreign application also cover the use of computer-assisted means to facilitate and expedite that detection process. The MatBA® microarray patents issued from the first of our family of applications in the microarray space. The term of these patents runs through 2030.
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Solid Tumors. We have 13 U.S. patents, including (U.S. Patent Nos. 7,049,059, 7,560,543, 7,732,144, 8,586,311, 8,026,062, 6,956,111, 6,905,821, 7,005,278, 6,686,155, 7,138,507, as well as numerous foreign patents, including patents in Australia, Canada, China and Japan. These patents
relate to certain aspects of the gene expression technology used in our solid tumor tests. The solid tumor markers covered by these patents include thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD), excision repair gene CC1 (ERCC1), glutathione-s transferase pi (GST-p), epidermal growth factor receptor (EGFR) and HER2/neu gene, though our patents are not directed to all aspects of expression of such markers.
The term of these patents runs through 2023.
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We have four U.S. patents (U.S. Patent Nos. 8,977,506, 8,321,137, 7,747,547 and 8,473,217) covering our Tissue of Origin® Test. These patents are directed at systems and methods for detecting biological features in solid tumors. The term of these patents run through 2030.
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Urogenital cancers. We have two U.S. patents (U.S. Patent Nos. 8,603,948 and 8,716,193) and one EU patent. These patents directed to a novel, highly sensitive and specific probe panel which detects the type of renal cortical neoplasm present in a biopsy sample. These patents cover a probe that permits diagnosis of the predominant subtypes of renal cortical neoplasms without the use of invasive methods and provides a molecular cytogenetic method for detecting and analyzing the type of renal cortical neoplasm present in a renal biopsy sample. The term of these patents runs through 2027. We also have two patent applications for methods and tools for the diagnosis of female gynecological cancers and precancers (US Patent Application No. 61/581,350) and methods and tools for the diagnosis and prognosis of urogenital cancers (US Patent Application No. 61/765,678).
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HPV-Associated Cancers. We have three U.S. patents (U.S. Patent Nos. 9,157,129, 8,865,882 and 8,883,414) and an EU patent. These patents cover methods for detecting HPV-associated cancers used in our FHACT® test. The term of these patents run through 2031.
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FISH Probes. We have two patents covering our FISH probes. These patents cover probes and methodologies designed to detect and analyze particular chromosomal translocations (genetic lesions) associated with a wide range of cancers using a technique known as FISH and serve as the backbone for several of our other pending patent applications, which are more specifically geared towards other probes (and methodologies). The term of these patents run through 2022.
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warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties;
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recalls, withdrawals, or administrative detention or seizure of products;
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operating restrictions or partial suspension or total shutdown of production;
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refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products;
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withdrawing 510(k) clearances or PMA approvals that have already been granted;
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refusal to grant export approvals for products; or
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criminal prosecution.
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Item 1A.
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Risk Factors.
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increase our sales and marketing efforts to drive market adoption and address competitive developments;
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fund development, validation and marketing efforts of current and future tests;
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comply with current and evolving regulatory requirements;
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further expand our clinical laboratory operations;
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expand our technologies into other types of cancer;
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acquire, license or invest in technologies;
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acquire or invest in complementary businesses or assets; and
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finance capital expenditures and general and administrative expenses.
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our ability to achieve revenue growth;
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our ability to continue to improve our operational efficiency;
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our ability to develop and obtain approvals for our new diagnostic tests and the costs associated with such research and development activities;
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our ability to execute on our marketing and sales strategy for our tests and gain acceptance of our tests in the market;
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our ability to obtain adequate reimbursement from governmental and other third-party payors for our tests and services;
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the costs, scope, progress, results, timing and outcomes of the clinical trials of our diagnostic tests;
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the costs of operating and enhancing our laboratory facilities;
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the costs of additional general and administrative personnel;
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the timing of and the costs involved in regulatory compliance, particularly if the regulations relating to laboratory developed tests (“LDTs”) change;
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the timing of and costs involved in regulatory compliance, particularly if the regulations relating the PPACA (Patient Protection and Affordable Care Act) change;
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the costs of maintaining, expanding and protecting our intellectual property portfolio, including potential litigation costs and liabilities;
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the effect of competing technological and market developments;
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costs related to international expansion; and
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our ability to secure financing and the amount thereof.
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not experimental or investigational;
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medically necessary;
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appropriate for the specific patient;
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cost-effective;
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supported by peer-reviewed publications; and
|
•
|
included in clinical practice guidelines.
|
•
|
the results of clinical trials;
|
•
|
the cost, performance and reliability of our tests and services, and the tests and services offered by competitors;
|
•
|
customers' perceptions regarding the benefits of our tests and services;
|
•
|
customers' satisfaction with our tests and services; and
|
•
|
marketing efforts and publicity regarding our tests and services.
|
•
|
failure of the tests at the research or development stage;
|
•
|
difficulty in accessing archival tissue samples, especially tissue samples with known clinical results; or
|
•
|
lack of sufficient clinical validation data to support the effectiveness of the test.
|
•
|
whether health care providers believe our diagnostic tests provide clinical utility;
|
•
|
whether the medical community accepts that our diagnostic tests are sufficiently sensitive and specific to be meaningful in patient care and treatment decisions; and
|
•
|
whether health insurers, government health programs and other third-party payors will cover and pay for our diagnostic tests and, if so, whether they will adequately reimburse us.
|
•
|
require us to dedicate a substantial portion of our cash flow from operations to payments on our debt, reducing the availability of our cash flow from operations to fund working capital, capital expenditures or other general corporate purposes;
|
•
|
limit our flexibility in planning for, or reacting to, changes in our business and industry;
|
•
|
place us at a disadvantage compared to competitors that may have proportionately less debt; and
|
•
|
increase our cost of borrowing.
|
•
|
Requires each medical device manufacturer to pay a sales tax equal to 2.3% of the price for which such manufacturer sells its medical devices, beginning in 2013. This tax may apply to some or all of our current products and products which are in development.
|
•
|
Mandates a reduction in payments for clinical laboratory services paid under the Medicare Clinical Laboratory Fee Schedule (“CLFS”) of 1.75% for the years 2011 through 2015. In addition, a productivity adjustment is made to the fee schedule payment amount. These changes in payments apply to some or all of the clinical laboratory test services we furnish to Medicare beneficiaries.
|
•
|
Establishes an Independent Payment Advisory Board to reduce the per capita rate of growth in Medicare spending. The Independent Payment Advisory Board has broad discretion to propose policies, which may have a negative impact on payment rates for services, including clinical laboratory services, beginning in 2016, and for hospital services beginning in 2020.
|
•
|
the federal Anti-kickback Statute, which prohibits, among other things, persons or entities from soliciting, receiving, offering or providing remuneration, directly or indirectly, in return for or to induce either the referral of an individual for, or the purchase order or recommendation of, any item or services for which payment may be made under a federal health care program such as the Medicare and Medicaid programs;
|
•
|
the federal physician self-referral prohibition, commonly known as the Stark Law, which prohibits physicians from referring Medicare or Medicaid patients to providers of "designated health services" with whom the physician or a member of the physician's immediate family has an ownership interest or compensation arrangement, unless a statutory or regulatory exception applies;
|
•
|
HIPAA, which established federal crimes for knowingly and willfully executing a scheme to defraud any health care benefit program or making false statements in connection with the delivery of or payment for health care benefits, items or services;
|
•
|
the federal civil monetary penalties law, which prohibits, among other things, offering or transferring remuneration, including waivers of co-payments and deductible amounts (or any part thereof), to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary's decision to order or receive items or services reimbursable by the government from a particular provider or supplier;
|
•
|
federal false claims laws, which, prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent; and
|
•
|
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers.
|
•
|
multiple, conflicting and changing laws and regulations such as tax and transfer pricing laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;
|
•
|
failure by us or our distributors to obtain regulatory approvals for the sale or use of our tests in various countries, including failure to achieve "CE Marking", a conformity mark which is required to market in vitro diagnostic medical devices in the European Economic Area and which is broadly accepted in other international markets;
|
•
|
difficulties in managing foreign operations;
|
•
|
complexities associated with managing multiple payor-reimbursement regimes or self-pay systems;
|
•
|
logistics and regulations associated with shipping tissue samples, including infrastructure conditions and transportation delays;
|
•
|
limits on our ability to penetrate international markets if our diagnostic tests cannot be processed by an appropriately qualified local laboratory;
|
•
|
financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to foreign currency exchange rate fluctuations;
|
•
|
reduced protection for intellectual property rights;
|
•
|
natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions; and
|
•
|
failure to comply with the Foreign Corrupt Practices Act, including its books and records provisions and its anti-bribery provisions, by maintaining accurate information and control over sales and distributors' activities.
|
•
|
our inability to enforce or obtain a remedy under any material agreements;
|
•
|
Chinese restrictions on foreign investment that could impair our ability to conduct our business or acquire or contract with other entities in the future;
|
•
|
restrictions on currency exchange that may limit our ability to use cash flow most effectively or to repatriate our investment;
|
•
|
fluctuations in currency values;
|
•
|
cultural, language and managerial differences that may reduce our overall performance; and
|
•
|
political instability.
|
•
|
progress, or lack of progress, in developing and commercializing our proprietary tests;
|
•
|
favorable or unfavorable decisions about our tests or services from government regulators, insurance companies or other third-party payors;
|
•
|
our ability to recruit and retain qualified regulatory and research and development personnel;
|
•
|
changes in investors' and securities analysts' perception of the business risks and conditions of our business;
|
•
|
changes in our relationship with key collaborators;
|
•
|
changes in the market valuation or earnings of our competitors or companies viewed as similar to us;
|
•
|
changes in key personnel;
|
•
|
depth of the trading market in our common stock;
|
•
|
changes in our capital structure, such as future issuances of securities or the incurrence of additional debt;
|
•
|
the granting or exercise of employee stock options or other equity awards;
|
•
|
realization of any of the risks described under this section titled “Risk Factors”; and
|
•
|
general market and economic conditions.
|
•
|
delaying, deferring or preventing a change in control;
|
•
|
impeding a merger, consolidation, takeover or other business combination involving us; or
|
•
|
discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.
|
•
|
allow the authorized number of directors to be changed only by resolution of our board of directors;
|
•
|
authorize our board of directors to issue, without stockholder approval, preferred stock, the rights of which will be determined at the discretion of the board of directors and that, if issued, could operate as a "poison pill" to dilute the stock ownership of a potential hostile acquirer to prevent an acquisition that our board of directors does not approve;
|
•
|
establish advance notice requirements for stockholder nominations to our board of directors or for stockholder proposals that can be acted on at stockholder meetings; and
|
•
|
limit who may call a stockholder meeting.
|
Item 1B.
|
Unresolved Staff Comments
|
Item 2.
|
Properties
|
Item 3.
|
Legal Proceedings
|
Item 4.
|
Mine Safety Disclosures
|
Item 5.
|
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
|
|
|
High
|
|
Low
|
||||
4
th
Quarter 2016
|
|
$
|
1.98
|
|
|
$
|
1.10
|
|
3
rd
Quarter 2016
|
|
$
|
2.73
|
|
|
$
|
1.72
|
|
2
nd
Quarter 2016
|
|
$
|
2.93
|
|
|
$
|
1.82
|
|
1
st
Quarter 2016
|
|
$
|
3.38
|
|
|
$
|
1.90
|
|
|
|
|
|
|
||||
4
th
Quarter 2015
|
|
$
|
8.51
|
|
|
$
|
2.75
|
|
3
rd
Quarter 2015
|
|
$
|
12.75
|
|
|
$
|
7.57
|
|
2
nd
Quarter 2015
|
|
$
|
12.22
|
|
|
$
|
7.57
|
|
1
st
Quarter 2015
|
|
$
|
9.76
|
|
|
$
|
6.55
|
|
|
|
Equity Compensation Plan Information
|
|
|
|||||||||
Plan Category
|
|
(a)
Number of securities
to be issued upon exercise
of outstanding options
and rights(1)
|
|
(b)
Weighted Average
exercise price of
outstanding options
and rights
|
|
(c)
Number of securities
remaining available for
future issuance under equity
compensation plan
(excluding securities
referenced in column (a))
|
|
|
|||||
Equity compensation plans approved by security holders (2)
|
|
2,162,073
|
|
|
$
|
9.07
|
|
|
1,211,609
|
|
|
(3
|
)
|
Equity compensation plans not approved by security holders (4)
|
|
36,000
|
|
|
$
|
10.00
|
|
|
—
|
|
|
|
|
Total
|
|
2,198,073
|
|
|
$
|
9.09
|
|
|
1,211,609
|
|
|
|
(4)
|
These options were issued to one of our current board members in connection with consulting services.
|
Item 6.
|
Selected Financial Data.
|
|
|
Year Ended December 31,
|
||||||||||||||||||
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
|
|
(in thousands, expect per share data)
|
||||||||||||||||||
Consolidated Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenue
|
|
$
|
27,049
|
|
|
$
|
18,040
|
|
|
$
|
10,199
|
|
|
$
|
6,610
|
|
|
$
|
4,302
|
|
Cost of revenues
|
|
17,104
|
|
|
14,098
|
|
|
8,453
|
|
|
4,925
|
|
|
3,929
|
|
|||||
Gross profit (loss)
|
|
9,945
|
|
|
3,942
|
|
|
1,746
|
|
|
1,685
|
|
|
373
|
|
|||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Research and development
|
|
5,967
|
|
|
5,483
|
|
|
4,622
|
|
|
2,190
|
|
|
2,112
|
|
|||||
General and administrative
|
|
16,034
|
|
|
14,567
|
|
|
12,369
|
|
|
6,115
|
|
|
4,503
|
|
|||||
Sales and marketing
|
|
4,668
|
|
|
5,269
|
|
|
3,964
|
|
|
1,842
|
|
|
1,399
|
|
|||||
Total operating expenses
|
|
26,669
|
|
|
25,319
|
|
|
20,955
|
|
|
10,147
|
|
|
8,014
|
|
|||||
Loss from operations
|
|
(16,724
|
)
|
|
(21,377
|
)
|
|
(19,209
|
)
|
|
(8,462
|
)
|
|
(7,641
|
)
|
|||||
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest expense
|
|
(454
|
)
|
|
(344
|
)
|
|
(473
|
)
|
|
(2,388
|
)
|
|
(4,701
|
)
|
|||||
Interest income
|
|
23
|
|
|
49
|
|
|
74
|
|
|
30
|
|
|
—
|
|
|||||
Change in fair value of warrant liability
|
|
1,525
|
|
|
35
|
|
|
417
|
|
|
4,633
|
|
|
7,538
|
|
|||||
Change in fair value of acquisition note payable
|
|
152
|
|
|
269
|
|
|
198
|
|
|
—
|
|
|
—
|
|
|||||
Loss on debt and warrant restructuring
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,862
|
)
|
|||||
Other expense
|
|
(325
|
)
|
|
—
|
|
|
—
|
|
|
(6,850
|
)
|
|
—
|
|
|||||
Total other income (expense)
|
|
921
|
|
|
9
|
|
|
216
|
|
|
(4,575
|
)
|
|
975
|
|
|||||
Loss before income taxes
|
|
(15,803
|
)
|
|
(21,368
|
)
|
|
(18,993
|
)
|
|
(13,037
|
)
|
|
(6,666
|
)
|
|||||
Income tax (benefit)
|
|
—
|
|
|
(1,184
|
)
|
|
(2,350
|
)
|
|
(664
|
)
|
|
—
|
|
|||||
Net (loss)
|
|
$
|
(15,803
|
)
|
|
$
|
(20,184
|
)
|
|
$
|
(16,643
|
)
|
|
$
|
(12,373
|
)
|
|
$
|
(6,666
|
)
|
Basic net (loss) per share
|
|
$
|
(1.00
|
)
|
|
$
|
(1.96
|
)
|
|
$
|
(1.76
|
)
|
|
$
|
(2.65
|
)
|
|
$
|
(4.97
|
)
|
Diluted net (loss) per share
|
|
$
|
(1.00
|
)
|
|
$
|
(1.96
|
)
|
|
$
|
(1.80
|
)
|
|
$
|
(3.64
|
)
|
|
$
|
(10.55
|
)
|
Basic weighted average shares outstanding
|
|
15,861
|
|
|
10,298
|
|
|
9,449
|
|
|
4,665
|
|
|
1,342
|
|
|||||
Diluted weighted average shares outstanding
|
|
15,861
|
|
|
10,299
|
|
|
9,462
|
|
|
4,676
|
|
|
1,346
|
|
|||||
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
|
Year Ended December 31,
|
||||||||||||||||||
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
|
2012
|
||||||||||
Consolidated Balance Sheet Data:
|
|
(in thousands)
|
||||||||||||||||||
Cash and cash equivalents
|
|
$
|
9,502
|
|
|
$
|
19,459
|
|
|
$
|
25,554
|
|
|
$
|
49,460
|
|
|
$
|
820
|
|
Working capital (deficit)
|
|
12,378
|
|
|
18,333
|
|
|
27,389
|
|
|
43,272
|
|
|
(9,612
|
)
|
|||||
Total assets
|
|
42,434
|
|
|
48,884
|
|
|
47,105
|
|
|
55,157
|
|
|
8,952
|
|
|||||
Debt, excluding current portion
|
|
2,654
|
|
|
4,642
|
|
|
6,000
|
|
|
—
|
|
|
8,441
|
|
|||||
Accumulated deficit
|
|
(113,954
|
)
|
|
(98,151
|
)
|
|
(77,967
|
)
|
|
(61,325
|
)
|
|
(48,935
|
)
|
|||||
Total stockholders' equity (deficit)
|
|
$
|
25,624
|
|
|
$
|
33,017
|
|
|
$
|
34,554
|
|
|
$
|
45,463
|
|
|
$
|
(23,981
|
)
|
Item 7.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
|
Year Ended December 31,
|
|
Change
|
|||||||||||
|
|
2016
|
|
2015
|
|
$
|
|
%
|
|||||||
(dollars in thousands)
|
|
|
|
|
|
|
|
|
|||||||
Revenue
|
|
$
|
27,049
|
|
|
$
|
18,040
|
|
|
$
|
9,009
|
|
|
50
|
%
|
Cost of revenues
|
|
17,104
|
|
|
14,098
|
|
|
3,006
|
|
|
21
|
%
|
|||
Research and development expenses
|
|
5,967
|
|
|
5,483
|
|
|
484
|
|
|
9
|
%
|
|||
General and administrative expenses
|
|
16,034
|
|
|
14,567
|
|
|
1,467
|
|
|
10
|
%
|
|||
Sales and marketing expenses
|
|
4,668
|
|
|
5,269
|
|
|
(601
|
)
|
|
-11
|
%
|
|||
Total operating loss
|
|
$
|
(16,724
|
)
|
|
$
|
(21,377
|
)
|
|
$
|
4,653
|
|
|
-22
|
%
|
Interest (expense)
|
|
(431
|
)
|
|
(295
|
)
|
|
(136
|
)
|
|
46
|
%
|
|||
Change in fair value of warrant liability
|
|
1,525
|
|
|
35
|
|
|
1,490
|
|
|
4,257
|
%
|
|||
Change in fair value of acquisition note payable
|
|
152
|
|
|
269
|
|
|
(117
|
)
|
|
-43
|
%
|
|||
Other expense
|
|
(325
|
)
|
|
—
|
|
|
(325
|
)
|
|
N/A
|
|
|||
Loss before income taxes
|
|
(15,803
|
)
|
|
(21,368
|
)
|
|
5,565
|
|
|
-26
|
%
|
|||
Income tax benefit
|
|
—
|
|
|
1,184
|
|
|
(1,184
|
)
|
|
-100
|
%
|
|||
Net loss
|
|
$
|
(15,803
|
)
|
|
$
|
(20,184
|
)
|
|
$
|
4,381
|
|
|
-22
|
%
|
|
Year Ended December 31,
|
|
Change
|
||||||||||||||
|
2016
|
|
2015
|
|
|
|
|
||||||||||
(dollars in thousands)
|
$
|
|
%
|
|
$
|
|
%
|
|
$
|
|
%
|
||||||
Biopharma Services
|
15,321
|
|
|
57
|
%
|
|
11,564
|
|
|
64
|
%
|
|
3,757
|
|
|
32
|
%
|
Clinical Services
|
10,651
|
|
|
39
|
%
|
|
5,651
|
|
|
31
|
%
|
|
5,000
|
|
|
88
|
%
|
Discovery Services
|
1,077
|
|
|
4
|
%
|
|
825
|
|
|
5
|
%
|
|
252
|
|
|
31
|
%
|
Total Revenue
|
27,049
|
|
|
100
|
%
|
|
18,040
|
|
|
100
|
%
|
|
9,009
|
|
|
50
|
%
|
|
|
Year Ended December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
(in thousands)
|
|
|
|
|
||||
Cash provided by (used in):
|
|
|
|
|
||||
Operating activities
|
|
$
|
(17,851
|
)
|
|
$
|
(13,599
|
)
|
Investing activities
|
|
(609
|
)
|
|
(2,640
|
)
|
||
Financing activities
|
|
8,503
|
|
|
10,144
|
|
||
Net increase (decrease) in cash and cash equivalents
|
|
$
|
(9,957
|
)
|
|
$
|
(6,095
|
)
|
•
|
our ability to achieve revenue growth and profitability;
|
•
|
the costs for funding the operations we recently acquired;
|
•
|
our ability to improve efficiency of billing and collection processes;
|
•
|
our ability to obtain approvals for our new diagnostic tests;
|
•
|
our ability to execute on our marketing and sales strategy for our tests and gain acceptance of our tests in the market;
|
•
|
our ability to obtain adequate reimbursement from governmental and other third-party payors for our tests and services;
|
•
|
the costs, scope, progress, results, timing and outcomes of the clinical trials of our tests;
|
•
|
the costs of operating and enhancing our laboratory facilities;
|
•
|
our ability to succeed with our cost control initiative;
|
•
|
the timing of and the costs involved in regulatory compliance, particularly if the regulations change;
|
•
|
the costs of maintaining, expanding and protecting our intellectual property portfolio, including potential litigation costs and liabilities;
|
•
|
our ability to manage the costs of manufacturing our tests;
|
•
|
our rate of progress in, and cost of research and development activities associated with, products in research and early development;
|
•
|
the effect of competing technological and market developments;
|
•
|
costs related to expansion;
|
•
|
our ability to secure financing and the amount thereof; and
|
•
|
other risks discussed in the section entitled “Risk Factors.”
|
|
|
Payments Due by Period
|
||||||||||||||||||
Contractual Obligations
|
|
Total
|
|
Less than 1 Year
|
|
1-3 Years
|
|
3-5 Years
|
|
More than 5 years
|
||||||||||
(dollars in thousands)
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Principal and interest under notes payable and lines of credit
|
|
$
|
4,991
|
|
|
$
|
2,216
|
|
|
$
|
2,775
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Capital Lease obligations, including interest, for equipment
|
|
549
|
|
|
136
|
|
|
243
|
|
|
170
|
|
|
—
|
|
|||||
Operating lease obligations relating to corporate headquarters and clinical laboratories
|
|
2,783
|
|
|
1,712
|
|
|
896
|
|
|
175
|
|
|
—
|
|
|||||
Total
|
|
$
|
8,323
|
|
|
$
|
4,064
|
|
|
$
|
3,914
|
|
|
$
|
345
|
|
|
$
|
—
|
|
•
|
Revenue recognition;
|
•
|
Accounts receivable and bad debts;
|
•
|
Stock-based compensation; and
|
•
|
Warrant liability.
|
Item 7A.
|
Qualitative and Quantitative Disclosures about Market Risk
|
Item 8.
|
Financial Statements and Supplementary Data
|
|
|
December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
ASSETS
|
|
|
|
|
||||
CURRENT ASSETS
|
|
|
|
|
||||
Cash and cash equivalents
|
|
$
|
9,502
|
|
|
$
|
19,459
|
|
Accounts receivable, net of allowance for doubtful accounts of 2016 $1,387; 2015 $664
|
|
11,748
|
|
|
6,621
|
|
||
Other current assets
|
|
2,174
|
|
|
2,118
|
|
||
Total current assets
|
|
23,424
|
|
|
28,198
|
|
||
FIXED ASSETS, net of accumulated depreciation
|
|
4,738
|
|
|
6,069
|
|
||
OTHER ASSETS
|
|
|
|
|
||||
Restricted cash
|
|
300
|
|
|
300
|
|
||
Patents and other intangible assets, net of accumulated amortization
|
|
1,503
|
|
|
1,727
|
|
||
Investment in joint venture
|
|
268
|
|
|
341
|
|
||
Goodwill
|
|
12,029
|
|
|
12,029
|
|
||
Other
|
|
172
|
|
|
220
|
|
||
Total other assets
|
|
14,272
|
|
|
14,617
|
|
||
Total Assets
|
|
$
|
42,434
|
|
|
$
|
48,884
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
||||
CURRENT LIABILITIES
|
|
|
|
|
||||
Accounts payable and accrued expenses
|
|
$
|
8,148
|
|
|
$
|
7,579
|
|
Obligations under capital leases, current portion
|
|
109
|
|
|
122
|
|
||
Deferred revenue
|
|
789
|
|
|
831
|
|
||
Bank term note, current portion
|
|
2,000
|
|
|
1,333
|
|
||
Total current liabilities
|
|
11,046
|
|
|
9,865
|
|
||
Bank term note
|
|
2,654
|
|
|
4,642
|
|
||
Obligations under capital leases
|
|
374
|
|
|
276
|
|
||
Deferred rent payable and other
|
|
290
|
|
|
315
|
|
||
Warrant liability
|
|
2,018
|
|
|
17
|
|
||
Deferred revenue, long-term
|
|
428
|
|
|
752
|
|
||
Total Liabilities
|
|
16,810
|
|
|
15,867
|
|
||
STOCKHOLDERS’ EQUITY
|
|
|
|
|
||||
Preferred stock, authorized 9,764 shares $0.0001 par value, none issued
|
|
—
|
|
|
—
|
|
||
Common stock, authorized 100,000 shares, $0.0001 par value, 18,936 and 13,652 shares issued and outstanding as of December 31, 2016 and 2015, respectively
|
|
2
|
|
|
1
|
|
||
Additional paid-in capital
|
|
139,576
|
|
|
131,167
|
|
||
Accumulated deficit
|
|
(113,954
|
)
|
|
(98,151
|
)
|
||
Total Stockholders’ Equity
|
|
25,624
|
|
|
33,017
|
|
||
Total Liabilities and Stockholders’ Equity
|
|
$
|
42,434
|
|
|
$
|
48,884
|
|
|
|
Years Ended December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
Revenue
|
|
$
|
27,049
|
|
|
$
|
18,040
|
|
Cost of revenues
|
|
17,104
|
|
|
14,098
|
|
||
Gross profit
|
|
9,945
|
|
|
3,942
|
|
||
Operating expenses:
|
|
|
|
|
||||
Research and development
|
|
5,967
|
|
|
5,483
|
|
||
General and administrative
|
|
16,034
|
|
|
14,567
|
|
||
Sales and marketing
|
|
4,668
|
|
|
5,269
|
|
||
Total operating expenses
|
|
26,669
|
|
|
25,319
|
|
||
Loss from operations
|
|
(16,724
|
)
|
|
(21,377
|
)
|
||
Other income (expense):
|
|
|
|
|
||||
Interest expense
|
|
(454
|
)
|
|
(344
|
)
|
||
Interest income
|
|
23
|
|
|
49
|
|
||
Change in fair value of warrant liability
|
|
1,525
|
|
|
35
|
|
||
Change in fair value of acquisition note payable
|
|
152
|
|
|
269
|
|
||
Other expense
|
|
(325
|
)
|
|
—
|
|
||
Total other income (expense)
|
|
921
|
|
|
9
|
|
||
Loss before income taxes
|
|
(15,803
|
)
|
|
(21,368
|
)
|
||
Income tax (benefit)
|
|
—
|
|
|
(1,184
|
)
|
||
Net (loss)
|
|
$
|
(15,803
|
)
|
|
$
|
(20,184
|
)
|
Basic net (loss) per share
|
|
$
|
(1.00
|
)
|
|
$
|
(1.96
|
)
|
Diluted net (loss) per share
|
|
$
|
(1.00
|
)
|
|
$
|
(1.96
|
)
|
Basic weighted average shares outstanding
|
|
15,861
|
|
|
10,298
|
|
||
Diluted weighted average shares outstanding
|
|
15,861
|
|
|
10,299
|
|
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Accumulated
Deficit |
|
Total
|
|||||||||||
|
|
Shares
|
|
Amount
|
|
||||||||||||||
Balance, December 31, 2014
|
|
9,821
|
|
|
1
|
|
|
112,520
|
|
|
(77,967
|
)
|
|
34,554
|
|
||||
Stock based compensation - employees
|
|
35
|
|
|
—
|
|
|
2,558
|
|
|
—
|
|
|
2,558
|
|
||||
Stock based compensation - non-employees
|
|
—
|
|
|
—
|
|
|
276
|
|
|
—
|
|
|
276
|
|
||||
Exercise of warrants
|
|
—
|
|
|
—
|
|
|
1
|
|
|
—
|
|
|
1
|
|
||||
Exercise of options
|
|
4
|
|
|
—
|
|
|
23
|
|
|
—
|
|
|
23
|
|
||||
Issuance of stock - Cantor Sales Agreement
|
|
3
|
|
|
—
|
|
|
34
|
|
|
—
|
|
|
34
|
|
||||
Issuance of stock - acquisition of Response Genetics
|
|
789
|
|
|
—
|
|
|
5,436
|
|
|
—
|
|
|
5,436
|
|
||||
Issuance of stock with warrants in 2015 Offering
|
|
3,000
|
|
|
—
|
|
|
10,319
|
|
|
—
|
|
|
10,319
|
|
||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(20,184
|
)
|
|
(20,184
|
)
|
||||
Balance, December 31, 2015
|
|
13,652
|
|
|
1
|
|
|
131,167
|
|
|
(98,151
|
)
|
|
33,017
|
|
||||
Stock based compensation—employees
|
|
16
|
|
|
—
|
|
|
1,978
|
|
|
—
|
|
|
1,978
|
|
||||
Stock based compensation—non-employees
|
|
—
|
|
|
—
|
|
|
38
|
|
|
—
|
|
|
38
|
|
||||
Issuance of stock - consultant
|
|
50
|
|
|
—
|
|
|
75
|
|
|
—
|
|
|
75
|
|
||||
Issuance of stock in 2016 Offerings
|
|
5,218
|
|
|
1
|
|
|
6,318
|
|
|
—
|
|
|
6,319
|
|
||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(15,803
|
)
|
|
(15,803
|
)
|
||||
Balance, December 31, 2016
|
|
18,936
|
|
|
$
|
2
|
|
|
$
|
139,576
|
|
|
$
|
(113,954
|
)
|
|
$
|
25,624
|
|
|
|
Years Ended December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
||||
Net loss
|
|
$
|
(15,803
|
)
|
|
$
|
(20,184
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
||||
Depreciation
|
|
2,032
|
|
|
1,503
|
|
||
Amortization
|
|
343
|
|
|
159
|
|
||
Provision for bad debts
|
|
723
|
|
|
413
|
|
||
Stock-based compensation
|
|
2,016
|
|
|
2,834
|
|
||
Stock issued for consulting services
|
|
75
|
|
|
—
|
|
||
Change in fair value of acquisition note payable
|
|
(152
|
)
|
|
269
|
|
||
Change in fair value of Gentris contingent consideration
|
|
—
|
|
|
(207
|
)
|
||
Change in fair value of warrant liability
|
|
(1,525
|
)
|
|
(35
|
)
|
||
Amortization of loan guarantee, financing fees and debt issuance costs
|
|
12
|
|
|
8
|
|
||
Loss in equity-method investment
|
|
73
|
|
|
707
|
|
||
Change in working capital components:
|
|
|
|
|
||||
Accounts receivable
|
|
(5,850
|
)
|
|
(1,662
|
)
|
||
Other current assets
|
|
(56
|
)
|
|
(384
|
)
|
||
Other non-current assets
|
|
(69
|
)
|
|
(101
|
)
|
||
Accounts payable, accrued expenses and deferred revenue
|
|
355
|
|
|
3,114
|
|
||
Deferred rent and other
|
|
(25
|
)
|
|
(33
|
)
|
||
Net cash (used in) operating activities
|
|
(17,851
|
)
|
|
(13,599
|
)
|
||
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
|
||||
Purchase of fixed assets
|
|
(490
|
)
|
|
(1,008
|
)
|
||
Decrease in restricted cash
|
|
—
|
|
|
6,000
|
|
||
Patent costs
|
|
(119
|
)
|
|
(137
|
)
|
||
Cash used in acquisition of Response Genetics
|
|
—
|
|
|
(7,495
|
)
|
||
Net cash (used in) investing activities
|
|
(609
|
)
|
|
(2,640
|
)
|
||
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
||||
Principal payments on capital lease obligations
|
|
(126
|
)
|
|
(83
|
)
|
||
Payment of equity issuance costs
|
|
—
|
|
|
(117
|
)
|
||
Proceeds from public offerings of equity, net of offering costs
|
|
9,962
|
|
|
10,353
|
|
||
Proceeds from warrant exercises
|
|
—
|
|
|
1
|
|
||
Proceeds from option exercises
|
|
—
|
|
|
23
|
|
||
Payment of debt issuance costs
|
|
—
|
|
|
(33
|
)
|
||
Principal payments on notes payable
|
|
(1,333
|
)
|
|
—
|
|
||
Net cash provided by financing activities
|
|
8,503
|
|
|
10,144
|
|
||
Net (decrease) in cash and cash
equivalents
|
|
(9,957
|
)
|
|
(6,095
|
)
|
||
CASH AND CASH EQUIVALENTS
|
|
|
|
|
||||
Beginning
|
|
19,459
|
|
|
25,554
|
|
||
Ending
|
|
$
|
9,502
|
|
|
$
|
19,459
|
|
SUPPLEMENTAL CASH FLOW DISCLOSURE
|
|
|
|
|
||||
Cash paid for interest
|
|
$
|
333
|
|
|
$
|
240
|
|
SUPPLEMENTAL DISCLOSURE OF NONCASH
|
|
|
|
|
||||
INVESTING AND FINANCING ACTIVITIES
|
|
|
|
|
||||
Fixed assets acquired through capital lease arrangements
|
|
$
|
211
|
|
|
$
|
—
|
|
Value of shares issued as partial consideration to purchase Response Genetics
|
|
—
|
|
|
5,436
|
|
||
Net tangible assets acquired via acquisition
|
|
—
|
|
|
2,843
|
|
Goodwill (in thousands)
|
||||
Balance, December 31, 2014
|
|
$
|
3,187
|
|
Purchased through acquisition of Response Genetics
|
|
8,842
|
|
|
Balance, December 31, 2015 and 2016
|
|
$
|
12,029
|
|
|
|
2016
|
|
2015
|
||||
Numerator:
|
|
|
|
|
||||
Net (loss) for basic earnings per share
|
|
$
|
(15,803
|
)
|
|
$
|
(20,184
|
)
|
Less change in fair value of warrant liability
|
|
—
|
|
|
35
|
|
||
Net (loss) for diluted earnings per share
|
|
$
|
(15,803
|
)
|
|
$
|
(20,219
|
)
|
Denominator:
|
|
|
|
|
||||
Weighted-average basic common shares outstanding
|
|
15,861
|
|
|
10,298
|
|
||
Assumed conversion of dilutive securities:
|
|
|
|
|
||||
Common stock purchase warrants
|
|
—
|
|
|
1
|
|
||
Potentially dilutive common shares
|
|
—
|
|
|
1
|
|
||
Denominator for diluted earnings per share—adjusted weighted-average shares
|
|
15,861
|
|
|
10,299
|
|
||
Basic net loss per share
|
|
$
|
(1.00
|
)
|
|
$
|
(1.96
|
)
|
Diluted net loss per share
|
|
$
|
(1.00
|
)
|
|
$
|
(1.96
|
)
|
|
|
2016
|
|
2015
|
||
Common stock purchase warrants
|
|
7,033
|
|
|
4,372
|
|
Stock options
|
|
2,198
|
|
|
1,961
|
|
Restricted shares of common stock
|
|
80
|
|
|
121
|
|
|
|
9,311
|
|
|
6,454
|
|
|
|
2016
|
|
2015
|
||||
Biopharma Services
|
|
$
|
15,321
|
|
|
$
|
11,564
|
|
Clinical Services
|
|
10,651
|
|
|
5,651
|
|
||
Discovery Services
|
|
1,077
|
|
|
825
|
|
||
|
|
$
|
27,049
|
|
|
$
|
18,040
|
|
|
|
2016
|
|
2015
|
||||
Biopharma Services
|
|
$
|
3,683
|
|
|
$
|
3,238
|
|
Clinical Services
|
|
8,972
|
|
|
3,733
|
|
||
Discovery Services
|
|
480
|
|
|
314
|
|
||
Allowance for doubtful accounts
|
|
(1,387
|
)
|
|
(664
|
)
|
||
|
|
$
|
11,748
|
|
|
$
|
6,621
|
|
|
|
2016
|
|
2015
|
||
Medicare
|
|
14
|
%
|
|
10
|
%
|
Other insurers
|
|
20
|
%
|
|
12
|
%
|
Other healthcare facilities
|
|
5
|
%
|
|
9
|
%
|
Total Clinical Services
|
|
39
|
%
|
|
31
|
%
|
|
|
2016
|
|
2015
|
||||
Inventory
|
|
$
|
146
|
|
|
$
|
133
|
|
Prepaid expenses
|
|
2,028
|
|
|
1,985
|
|
||
|
|
$
|
2,174
|
|
|
$
|
2,118
|
|
|
|
Capital
Leases
|
|
Operating
Leases
|
|
Total
|
||||||
December 31,
|
|
|
|
|
|
|
||||||
2017
|
|
$
|
136
|
|
|
$
|
1,712
|
|
|
$
|
1,848
|
|
2018
|
|
130
|
|
|
513
|
|
|
643
|
|
|||
2019
|
|
113
|
|
|
383
|
|
|
496
|
|
|||
2020
|
|
102
|
|
|
175
|
|
|
277
|
|
|||
2021
|
|
68
|
|
|
—
|
|
|
68
|
|
|||
Thereafter
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total minimum lease payments
|
|
$
|
549
|
|
|
$
|
2,783
|
|
|
$
|
3,332
|
|
Less amount representing interest
|
|
66
|
|
|
|
|
|
|||||
Present value of net minimum obligations
|
|
483
|
|
|
|
|
|
|||||
Less current obligation under capital lease
|
|
109
|
|
|
|
|
|
|||||
Long-term obligation under capital lease
|
|
$
|
374
|
|
|
|
|
|
|
|
2016
|
|
2015
|
||||
Term note, principal balance
|
|
$
|
4,667
|
|
|
$
|
6,000
|
|
Less unamortized debt issuance costs
|
|
13
|
|
|
25
|
|
||
Term note, net
|
|
4,654
|
|
|
5,975
|
|
||
Less current maturities
|
|
2,000
|
|
|
1,333
|
|
||
Long-term portion
|
|
$
|
2,654
|
|
|
$
|
4,642
|
|
|
|
2016
|
|
2015
|
||||
Equipment
|
|
$
|
9,094
|
|
|
$
|
8,442
|
|
Furniture and fixtures
|
|
1,068
|
|
|
1,083
|
|
||
Leasehold improvements
|
|
932
|
|
|
932
|
|
||
|
|
11,094
|
|
|
10,457
|
|
||
Less accumulated depreciation
|
|
(6,356
|
)
|
|
(4,388
|
)
|
||
Net fixed assets
|
|
$
|
4,738
|
|
|
$
|
6,069
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
|
|
Weighted-Average
|
||||
|
|
(in thousands)
|
|
(in thousands)
|
|
Amortization
|
||||
|
|
2016
|
|
2015
|
|
Period
|
||||
Patents
|
|
$
|
843
|
|
|
$
|
724
|
|
|
10 years
|
Patents - Response Genetics acquisition
|
|
800
|
|
|
800
|
|
|
7 years
|
||
Software - Response Genetics acquisition
|
|
446
|
|
|
446
|
|
|
2 years
|
||
|
|
2,089
|
|
|
1,970
|
|
|
|
||
Less accumulated amortization
|
|
(586
|
)
|
|
(243
|
)
|
|
|
||
Net patent and other intangible assets
|
|
$
|
1,503
|
|
|
$
|
1,727
|
|
|
|
2017
|
$
|
289
|
|
2018
|
200
|
|
|
2019
|
153
|
|
|
2020
|
145
|
|
|
2021
|
139
|
|
|
2022 and thereafter
|
133
|
|
|
Total
|
$
|
1,059
|
|
|
|
For the Year Ended December 31, 2016
|
|
For the Year Ended December 31, 2015
|
||||||||||
|
|
Amount
(in thousands) |
|
% of
Pretax Loss |
|
Amount
(in thousands) |
|
% of
Pretax Loss |
||||||
Income tax benefit at federal statutory rate
|
|
$
|
(5,531
|
)
|
|
35.0
|
%
|
|
$
|
(7,479
|
)
|
|
35.0
|
%
|
State tax provision, net of federal tax benefit
|
|
(777
|
)
|
|
4.9
|
%
|
|
(878
|
)
|
|
4.1
|
%
|
||
Tax credits
|
|
(342
|
)
|
|
2.2
|
%
|
|
(232
|
)
|
|
1.1
|
%
|
||
Stock based compensation
|
|
206
|
|
|
(1.3
|
)%
|
|
201
|
|
|
(0.9
|
)%
|
||
Derivative warrants
|
|
(534
|
)
|
|
3.4
|
%
|
|
(12
|
)
|
|
0.1
|
%
|
||
Investor consideration
|
|
—
|
|
|
—
|
%
|
|
(110
|
)
|
|
0.5
|
%
|
||
Change in valuation allowance
|
|
7,459
|
|
|
(47.2
|
)%
|
|
6,617
|
|
|
(31.0
|
)%
|
||
Foreign operations
|
|
251
|
|
|
(1.6
|
)%
|
|
283
|
|
|
(1.3
|
)%
|
||
Other
|
|
(732
|
)
|
|
4.6
|
%
|
|
426
|
|
|
(2.1
|
)%
|
||
Income tax (benefit) provision
|
|
$
|
—
|
|
|
—
|
%
|
|
$
|
(1,184
|
)
|
|
5.5
|
%
|
|
|
2016
|
|
2015
|
||||
Deferred tax assets:
|
|
|
|
|
||||
Net operating loss carryforwards
|
|
$
|
32,273
|
|
|
$
|
25,085
|
|
Accruals and reserves
|
|
1,829
|
|
|
1,100
|
|
||
Non-qualified stock options
|
|
3,882
|
|
|
3,357
|
|
||
Research and development tax credits
|
|
1,331
|
|
|
989
|
|
||
Derivative warrant liability
|
|
26
|
|
|
26
|
|
||
Investment in joint venture
|
|
250
|
|
|
251
|
|
||
Goodwill
|
|
—
|
|
|
283
|
|
||
Fixed assets
|
|
—
|
|
|
78
|
|
||
Other
|
|
8
|
|
|
6
|
|
||
Total deferred tax assets
|
|
39,599
|
|
|
31,175
|
|
||
Less valuation allowance
|
|
(38,634
|
)
|
|
(31,175
|
)
|
||
Net deferred tax assets
|
|
965
|
|
|
—
|
|
||
Deferred tax liabilities
|
|
|
|
|
||||
Fixed assets
|
|
(401
|
)
|
|
—
|
|
||
Goodwill and intangible assets
|
|
(564
|
)
|
|
—
|
|
||
Net deferred taxes
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
Options Outstanding
|
|
Weighted-
Average
Remaining
Contractual
Term (in years)
|
|
Aggregate
Intrinsic
Value
(in thousands)
|
|||||||
|
|
Number of
Shares
(in thousands)
|
|
Weighted-
Average
Exercise
Price
|
|
||||||||
Outstanding January 1, 2015
|
|
1,839
|
|
|
$
|
10.58
|
|
|
8.49
|
|
$
|
618
|
|
Granted
|
|
312
|
|
|
9.77
|
|
|
|
|
|
|||
Exercised
|
|
(4
|
)
|
|
5.37
|
|
|
|
|
|
|||
Cancelled or expired
|
|
(186
|
)
|
|
9.69
|
|
|
|
|
|
|||
Outstanding December 31, 2015
|
|
1,961
|
|
|
$
|
10.55
|
|
|
7.68
|
|
$
|
—
|
|
Granted
|
|
417
|
|
|
1.95
|
|
|
|
|
|
|||
Cancelled or expired
|
|
(180
|
)
|
|
8.44
|
|
|
|
|
|
|||
Outstanding December 31, 2016
|
|
2,198
|
|
|
$
|
9.09
|
|
|
7.04
|
|
$
|
—
|
|
Exercisable, December 31, 2016
|
|
1,343
|
|
|
$
|
10.18
|
|
|
6.13
|
|
$
|
—
|
|
|
|
Year Ended December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
Volatility
|
|
73.86
|
%
|
|
60.69
|
%
|
||
Risk free interest rate
|
|
1.25
|
%
|
|
1.63
|
%
|
||
Dividend yield
|
|
—
|
|
|
—
|
|
||
Term (years)
|
|
5.93
|
|
|
6.13
|
|
||
Weighted-average fair value of options granted during the period
|
|
$
|
1.26
|
|
|
$
|
5.54
|
|
|
|
Year Ended December 31,
|
||||
|
|
2016
|
|
2015
|
||
Volatility
|
|
74.08
|
%
|
|
70.38
|
%
|
Risk free interest rate
|
|
1.64
|
%
|
|
2.10
|
%
|
Dividend yield
|
|
—
|
|
|
—
|
|
Term (years)
|
|
7.76
|
|
|
8.73
|
|
|
|
|
|
Non-vested Restricted Stock Awards
|
|||||
|
|
|
|
Number of Shares (in thousands)
|
|
Weighted-Average Grant Date Fair Value
|
|||
Non-vested at January 1, 2015
|
|
|
|
133
|
|
|
$
|
8.14
|
|
Granted
|
|
|
|
48
|
|
|
9.50
|
|
|
Vested
|
|
|
|
(47
|
)
|
|
9.09
|
|
|
Forfeited/cancelled
|
|
|
|
(13
|
)
|
|
9.03
|
|
|
Non-vested at December 31, 2015
|
|
|
|
121
|
|
|
$
|
8.25
|
|
Granted
|
|
|
|
18
|
|
|
1.81
|
|
|
Vested
|
|
|
|
(57
|
)
|
|
8.99
|
|
|
Forfeited/cancelled
|
|
|
|
(2
|
)
|
|
9.02
|
|
|
Non-vested at December 31, 2016
|
|
|
|
80
|
|
|
$
|
6.30
|
|
|
|
Year Ended December 31,
|
||||||
|
|
2016
|
|
2015
|
||||
Cost of revenues
|
|
$
|
290
|
|
|
$
|
233
|
|
Research and development
|
|
172
|
|
|
360
|
|
||
General and administrative
|
|
1,446
|
|
|
2,106
|
|
||
Sales and marketing
|
|
108
|
|
|
135
|
|
||
Total stock-based compensation
|
|
$
|
2,016
|
|
|
$
|
2,834
|
|
Issued With / For
|
|
Exercise
Price |
|
|
Warrants
Outstanding January 1, 2015 |
|
2015
Warrants Issued |
|
2015 Offering Adjustments (B)
|
|
2015
Warrants Expired |
|
Warrants
Outstanding December 31, 2015 |
|
2016
Warrants Issued |
|
2016
Warrants Expired |
|
Warrants
Outstanding December 31, 2016 |
||||||||||
Non-Derivative Warrants:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Financing
|
|
$
|
10.00
|
|
|
|
243
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
243
|
|
|
—
|
|
|
—
|
|
|
243
|
|
Financing
|
|
15.00
|
|
|
|
436
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
436
|
|
|
—
|
|
|
(75
|
)
|
|
361
|
|
|
Debt Guarantee
|
|
15.00
|
|
|
|
353
|
|
|
—
|
|
|
—
|
|
|
(120
|
)
|
|
233
|
|
|
—
|
|
|
(124
|
)
|
|
109
|
|
|
Consulting
|
|
10.00
|
|
|
|
29
|
|
|
—
|
|
|
—
|
|
|
(19
|
)
|
|
10
|
|
|
—
|
|
|
(10
|
)
|
|
—
|
|
|
2015 Offering
|
|
5.00
|
|
|
|
—
|
|
|
3,450
|
|
|
—
|
|
|
—
|
|
|
3,450
|
|
|
—
|
|
|
—
|
|
|
3,450
|
|
|
|
|
$
|
6.42
|
|
D
|
|
1,061
|
|
|
3,450
|
|
|
—
|
|
|
(139
|
)
|
|
4,372
|
|
|
—
|
|
|
(209
|
)
|
|
4,163
|
|
Derivative Warrants:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Financing
|
|
4.00
|
|
A
|
|
—
|
|
|
—
|
|
|
60
|
|
|
—
|
|
|
60
|
|
|
—
|
|
|
(60
|
)
|
|
—
|
|
|
Financing
|
|
10.00
|
|
A
|
|
60
|
|
|
—
|
|
|
(60
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Series B Pref. Stock
|
|
4.00
|
|
A
|
|
—
|
|
|
—
|
|
|
15
|
|
|
(15
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Series B Pref. Stock
|
|
10.00
|
|
A
|
|
15
|
|
|
—
|
|
|
(15
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2016 Offerings
|
|
2.25
|
|
C
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,870
|
|
|
—
|
|
|
2,870
|
|
|
|
|
$
|
2.25
|
|
D
|
|
75
|
|
|
—
|
|
|
—
|
|
|
(15
|
)
|
|
60
|
|
|
2,870
|
|
|
(60
|
)
|
|
2,870
|
|
|
|
$
|
4.72
|
|
D
|
|
1,136
|
|
|
3,450
|
|
|
—
|
|
|
(154
|
)
|
|
4,432
|
|
|
2,870
|
|
|
(269
|
)
|
|
7,033
|
|
A
|
These warrants are subject to fair value accounting and contain an exercise price adjustment feature. See Note 14.
|
B
|
On November 12, 2015 the Company completed the 2015 Offering and the exercise price of certain derivative warrants were adjusted to
$4.00
.
|
C
|
These warrants are subject to fair value accounting and contain a contingent net cash settlement feature. See Note 14.
|
D
|
Weighted average exercise prices are as of December 31, 2016.
|
Series B
|
|
Exercised During the Year Ended December 31, 2015
|
||
Exercise Price
|
|
$
|
4.00
|
|
Expected life (years)
|
|
0.01
|
|
|
Expected volatility
|
|
12.33
|
%
|
|
Risk-free interest rate
|
|
0.07
|
%
|
|
Expected dividend yield
|
|
0.00
|
%
|
|
|
As of December 31,
|
||
Financing
|
|
2015
|
||
Exercise Price
|
|
$
|
4.00
|
|
Expected life (years)
|
|
0.23
|
|
|
Expected volatility
|
|
70.82
|
%
|
|
Risk-free interest rate
|
|
0.16
|
%
|
|
Expected dividend yield
|
|
0.00
|
%
|
|
|
Issued During the Year Ended December 31, 2016
|
|
As of December 31, 2016
|
|||
2016 Offerings
|
|
|
|||||
Exercise Price
|
|
$
|
2.25
|
|
|
2.25
|
|
Expected life (years)
|
|
5.50
|
|
|
5.06
|
|
|
Expected volatility
|
|
74.36
|
%
|
|
72.82
|
%
|
|
Risk-free interest rate
|
|
1.30
|
%
|
|
1.93
|
%
|
|
Expected dividend yield
|
|
0.00
|
%
|
|
0.00
|
%
|
|
|
Issued with 2016 Offerings
|
|
Issued with
Series B Preferred Stock |
|
Issued For
Financing |
|
Total
|
||||||||
Fair value of warrants outstanding as of January 1, 2015
|
|
—
|
|
|
8
|
|
|
44
|
|
|
52
|
|
||||
Change in fair value of warrants
|
|
—
|
|
|
(8
|
)
|
|
(27
|
)
|
|
(35
|
)
|
||||
Fair value of warrants outstanding as of December 31, 2015
|
|
—
|
|
|
—
|
|
|
17
|
|
|
17
|
|
||||
Fair value of warrants issued
|
|
3,526
|
|
|
—
|
|
|
—
|
|
|
3,526
|
|
||||
Change in fair value of warrants
|
|
(1,508
|
)
|
|
—
|
|
|
(17
|
)
|
|
(1,525
|
)
|
||||
Fair value of warrants outstanding as of December 31, 2016
|
|
$
|
2,018
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,018
|
|
|
|
2016
|
||||||||||||
|
|
Total
|
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
||||||
Warrant liability
|
|
$
|
2,018
|
|
|
—
|
|
|
—
|
|
|
$
|
2,018
|
|
Notes payable
|
|
114
|
|
|
—
|
|
|
—
|
|
|
114
|
|
||
|
|
$
|
2,132
|
|
|
—
|
|
|
—
|
|
|
$
|
2,132
|
|
|
|
|
|
|
|
|
|
|
||||||
|
|
2015
|
||||||||||||
|
|
Total
|
|
Quoted Prices in
Active Markets for Identical Assets (Level 1) |
|
Significant Other
Observable Inputs (Level 2) |
|
Significant
Unobservable Inputs (Level 3) |
||||||
Warrant liability
|
|
$
|
17
|
|
|
—
|
|
|
—
|
|
|
$
|
17
|
|
Notes payable
|
|
266
|
|
|
—
|
|
|
—
|
|
|
266
|
|
||
|
|
$
|
283
|
|
|
—
|
|
|
—
|
|
|
$
|
283
|
|
|
|
Note Payable
|
|
Gentris Contingent
|
||||
|
|
to VenturEast
|
|
Consideration
|
||||
Fair value at January 1, 2015
|
|
$
|
535
|
|
|
$
|
293
|
|
Change in fair value
|
|
(269
|
)
|
|
(207
|
)
|
||
Settlement of liability
|
|
—
|
|
|
(86
|
)
|
||
Fair value at December 31, 2015
|
|
$
|
266
|
|
|
$
|
—
|
|
Change in fair value
|
|
(152
|
)
|
|
—
|
|
||
Fair value at December 31, 2016
|
|
$
|
114
|
|
|
$
|
—
|
|
|
Amount
|
||
Accounts receivable
|
$
|
344
|
|
Prepaid expenses and other current assets
|
561
|
|
|
Fixed assets
|
2,254
|
|
|
Intangible assets
|
1,246
|
|
|
Goodwill
|
8,842
|
|
|
Current liabilities
|
(194
|
)
|
|
Obligations under capital lease
|
(122
|
)
|
|
Total purchase price
|
$
|
12,931
|
|
Item 9.
|
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
|
Item 9A.
|
Controls and Procedures.
|
•
|
Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the Company;
|
•
|
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of our management and directors; and
|
•
|
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.
|
Item 9B.
|
Other Information.
|
Item 10.
|
Directors, Executive Officers and Corporate Governance.
|
Item 11.
|
Executive Compensation.
|
Item 12.
|
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
|
Item 13.
|
Certain Relationships and Related Transactions, and Director Independence.
|
Item 14.
|
Principal Accounting Fees and Services.
|
Item 15.
|
Exhibits, Financial Statement Schedules.
|
Item 16.
|
Form 10-K Summary.
|
|
|
|
|
|
|
|
|
|
|
|
Cancer Genetics, Inc.
(Registrant)
|
||
|
|
|
|
|||
Date: March 23, 2017
|
|
|
|
|
|
/s/ Panna L. Sharma
|
|
|
|
|
|
|
Panna L. Sharma
|
|
|
|
|
|
|
President and Chief Executive Officer
(Principal Executive Officer and
duly authorized signatory)
|
|
|
|
|
|||
Date: March 23, 2017
|
|
|
|
|
|
/s/ John A. Roberts
|
|
|
|
|
|
|
John A. Roberts
|
|
|
|
|
|
|
Chief Operating Officer and
Executive Vice President, Finance
(Principal Financial Officer)
|
|
|
|
|
|||
Date: March 23, 2017
|
|
|
|
|
|
/s/ Igor Gitelman
|
|
|
|
|
|
|
Igor Gitelman
|
|
|
|
|
|
|
Chief Accounting Officer
(Principal Accounting Officer)
|
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
||
/s/ Panna L. Sharma
|
|
President, Chief Executive Officer and Director
|
|
March 23, 2017
|
Panna L. Sharma
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
/s/ John A. Roberts
|
|
Chief Operating Officer and Executive Vice President, Finance
|
|
March 23, 2017
|
John A. Roberts
|
|
(Principal Financial Officer)
|
|
|
|
|
|
|
|
/s/ Igor Gitelman
|
|
Chief Accounting Officer
|
|
March 23, 2017
|
Igor Gitelman
|
|
(Principal Accounting Officer)
|
|
|
|
|
|
|
|
/s/ John Pappajohn
|
|
Chairman of the Board of Directors
|
|
March 23, 2017
|
John Pappajohn
|
|
|
|
|
|
|
|
||
/s/ Geoffrey Harris
|
|
Director
|
|
March 23, 2017
|
Geoffrey Harris
|
|
|
|
|
|
|
|
||
/s/ Edmund Cannon
|
|
Director
|
|
March 23, 2017
|
Edmund Cannon
|
|
|
|
|
|
|
|
|
|
/s/ Howard McLeod
|
|
Director
|
|
March 23, 2017
|
Howard McLeod
|
|
|
|
|
|
|
|
||
/s/ Michael J. Welsh
|
|
Director
|
|
March 23, 2017
|
Michael J. Welsh
|
|
|
|
|
|
|
|
|
|
/s/ Raju S. K. Chaganti
|
|
Director
|
|
March 23, 2017
|
Raju S. K. Chaganti, Ph.D.
|
|
|
|
|
|
|
|
||
/s/ Franklyn G. Prendergast
|
|
Director
|
|
March 23, 2017
|
Franklyn G. Prendergast, M.D., Ph.D.
|
|
|
|
|
|
|
|
Exhibit
No.
|
|
Description
|
|
|
|
10.8
|
|
Medical Director Agreement, between Cancer Genetics, Inc. and Lan Wang, M.D., dated October 9, 2009, filed as Exhibit 10.9 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.9
|
|
Consulting Agreement, between Cancer Genetics, Inc. and R.S.K. Chaganti, dated September 15, 2010, filed as Exhibit 10.15 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.10
|
|
Employment Agreement, between Panna Sharma and Cancer Genetics, Inc., effective as of April 1, 2010, filed as Exhibit 10.17 to Form S-1/A filed on February 14, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.11
|
|
Employment Agreement, between Jane Houldsworth El Naggar, Ph.D. and Cancer Genetics, Inc., effective as of January 1, 2012, filed as Exhibit 10.19 to Form S-1/A filed on February 14, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.12
|
|
Office Lease Agreement, between Cancer Genetics, Inc. and Onyx Equities, LLC, dated October 9, 2007, filed as Exhibit 10.20 to Form S-1/A filed on April 23, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.13
|
|
Credit Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated April 29, 2008, filed as Exhibit 10.21 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.14
|
|
Security Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated April 29, 2008, filed as Exhibit 10.22 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.15
|
|
First Addendum to Credit Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated July 7, 2008, filed as Exhibit 10.23 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.16
|
|
Second Addendum to Credit Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated March 30, 2009, filed as Exhibit 10.24 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.17
|
|
Third Addendum to Credit Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated July 2, 2009, filed as Exhibit 10.25 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference
|
|
|
|
10.18
|
|
Fourth Addendum to Credit Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated October 21, 2009, filed as Exhibit 10.26 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.19
|
|
Fifth Addendum to Credit Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated July 29, 2010, filed as Exhibit 10.27 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.20
|
|
Credit Agreement, between Cancer Genetics, Inc. and DAM Holdings, LLC, dated March 23, 2011, filed as Exhibit 10.28 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.21
|
|
Inter-creditor Agreement, between Cancer Genetics, Inc., John Pappajohn and DAM Holdings, LLC, dated March 23, 2011, filed as Exhibit 10.29 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.22
|
|
General Business Security Agreement, between Cancer Genetics, Inc. and DAM Holdings, LLC, dated March 23, 2011, filed as Exhibit 10.30 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.23
|
|
Promissory Note, issued by Cancer Genetics, Inc. to DAM Holdings, LLC, dated March 23, 2011, filed as Exhibit 10.31 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.24
|
|
Sixth Addendum to Credit Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated June 6, 2011, filed as Exhibit 10.32 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.25
|
|
Amended and Restated Credit Agreement, by and among Cancer Genetics, Inc., John Pappajohn, Pecora and Company and NNJCA Capital, LLC dated February 13, 2012, filed as Exhibit 10.33 to Form S-1/A filed on March 13, 2012 (File No. 333-178836) and incorporated herein by reference.
|
Exhibit
No.
|
|
Description
|
|
|
|
10.26
|
|
Form of Promissory Note issued by Cancer Genetics, Inc. to John Pappajohn, filed as Exhibit 10.34 to Form S-1/A filed on March 13, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.27
|
|
Form of Promissory Note issued by Cancer Genetics, Inc. to NNJCA Capital, LLC and Pecora and Company, filed as Exhibit 10.35 to Form S-1/A filed on March 13, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.28
|
|
Inter-Creditor Agreement, between Cancer Genetics, Inc., John Pappajohn, DAM Holdings, LLC, Pecora and Company, NNJCA Capital, LLC and Equity Dynamics, Inc., dated February 13, 2012, filed as Exhibit 10.37 to Form S-1/A filed on March 13, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.29
|
|
Seventh Addendum to Credit Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated February 15, 2012, filed as Exhibit 10.38 to Form S-1/A filed on March 13, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.30
|
|
Amendment to Credit Agreement, between Cancer Genetics, Inc. and DAM Holdings, LLC, dated March 9, 2012, filed as Exhibit 10.33 to Form S-1/A filed on March 13, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.31
|
|
Affiliation Agreement, between Cancer Genetics, Inc. and Mayo Foundation for Medical Education and Research dated November 7, 2011, filed as Exhibit 10.35 to Form S-1 filed on December 30, 2011 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.32
|
|
Consulting Agreement with Equity Dynamics, Inc., filed as Exhibit 10.38 to Form S-1/A filed on February 14, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.33
|
|
Letter Agreement, between Meadows Office, L.L.C. and Cancer Genetics, Inc., dated January 10, 2008, filed as Exhibit 10.44 to Form S-1/A filed on April 23, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.34
|
|
Letter of Credit from JPMorgan Chase Bank, N.A., dated April 19, 2012, filed as Exhibit 10.46 to Form S-1/A filed on April 30, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.35
|
|
Letter Agreement between Cancer Genetics, Inc. and John Pappajohn, filed as Exhibit 10.47 to Form S-1/A filed on May 7, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.36
|
|
Amendment No. 1 to Affiliation Agreement, between Cancer Genetics, Inc. and Mayo Foundation for Medical Education and Research, dated September 29, 2012, filed as Exhibit 10.49 to Form S-1/A filed on October 23, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.37
|
|
Restated Credit Agreement, between Mark Oman and John Pappajohn and Cancer Genetics, Inc., dated October 17, 2012, filed as Exhibit 10.51 to Form S-1/A filed on October 23, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.38
|
|
Form of Restated Promissory Note issued by Cancer Genetics, Inc. to John Pappajohn and Mark Oman, filed as Exhibit 10.52 to Form S-1/A filed on October 23, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.39
|
|
Restated Registration Rights Agreement, between Cancer Genetics, Inc., Mark Oman and John Pappajohn, dated October 17, 2012, filed as Exhibit 10.54 to Form S-1/A filed on October 23, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.40
|
|
Letter Agreement between Cancer Genetics, Inc. and Pecora, filed as Exhibit 10.55 to Form S-1/A filed on October 23, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.41
|
|
Letter Agreement between Cancer Genetics, Inc. and NNJCA Capital, LLC, filed as Exhibit 10.56 to Form S-1/A filed on October 23, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.42
|
|
Letter Agreement between Cancer Genetics, Inc. and DAM Holdings, Inc., filed as Exhibit 10.57 to Form S-1/A filed on October 23, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.43
|
|
Eighth Addendum to Credit Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated October 18, 2012, filed as Exhibit 10.58 to Form S-1/A filed on November 16, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.44
|
|
Credit Agreement between John Pappajohn and Cancer Genetics, Inc. dated December 4, 2012, filed as Exhibit 10.59 to Form S-1/A filed on December 14, 2012 (File No. 333-178836) and incorporated herein by reference.
|
Exhibit
No.
|
|
Description
|
|
|
|
10.45
|
|
Promissory Note issued by Cancer Genetics, Inc. to John Pappajohn dated December 4, 2012, filed as Exhibit 10.60 to Form S-1/A filed on December 14, 2012 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.46
|
|
Amendment No. 2 to Affiliation Agreement between Cancer Genetics, Inc. and Mayo Foundation for Medical Education and Research, dated January 4, 2013, filed as Exhibit 10.61 to Form S-1/A filed on January 8, 2013 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.47
|
|
Letter Agreement between Cancer Genetics, Inc. and John Pappajohn dated February 11, 2013, filed as Exhibit 10.63 to Form S-1/A filed on February 12, 2013 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.48
|
|
Letter Agreement between Cancer Genetics, Inc. and John Pappajohn (on behalf of his spouse) dated February 13, 2013, filed as Exhibit 10.64 to Form S-1/A filed on February 14, 2013 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.49
|
|
Letter Agreement between Cancer Genetics, Inc. and NNJCA Capital, LLC dated as of February 13, 2013, filed as Exhibit 10.65 to Form S-1/A filed on February 14, 2013 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.50
|
|
Letter Agreement between Cancer Genetics, Inc. and DAM Holdings, LLC dated February 13, 2013, filed as Exhibit 10.66 to Form S-1/A filed on February 14, 2013 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.51
|
|
Letter Agreement between Cancer Genetics, Inc. and R.S.K. Chaganti, dated February 13, 2013, filed as Exhibit 10.67 to Form S-1/A filed on March 4, 2013 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.52
|
|
Form of Letter Agreement between Cancer Genetics, Inc. and certain warrant holders waiving certain anti-dilution rights, filed as Exhibit 10.68 to Form S-1/A filed on March 4, 2013 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.53
|
|
Letter Amendment dated March 20, 2013 to Letter Agreement, between Meadows Office, L.L.C. and Cancer Genetics, Inc., dated April 6, 2012, filed as Exhibit 10.72 to Form S-1/A filed on March 22, 2013 (File No. 333-178836) and incorporated herein by reference.
|
|
|
|
10.54
|
|
Amendment No. 3 to Affiliation Agreement between the Company and Mayo Foundation for Medical Education and Research, dated May 21, 2013, filed as Exhibit 10.73 to Form S-1 filed on June 5, 2013 (File No. 333-189117) and incorporated herein by reference.
|
|
|
|
10.55
|
|
Limited Liability Company Agreement of OncoSpire Genomics, LLC, dated May 21, 2013, filed as Exhibit 10.74 to Form S-1/A filed on July 12, 2013 (File No. 333-189117) and incorporated herein by reference.
|
|
|
|
10.56
|
|
Joint Development Intellectual Property Agreement, among the Company, Mayo Foundation for Medical Education and Research and OncoSpire Genomics, LLC, dated May 21, 2013, filed as Exhibit 10.75 to Form S-1/A filed on July 12, 2013 (File No. 333-189117) and incorporated herein by reference.
|
|
|
|
10.57
|
|
Letter Agreement, between Cancer Genetics, Inc. and Andrew L. Pecora, effective February 18, 2014 (incorporated by reference to Exhibit 10.66 of the Company's Annual Report on Form 10-K for the year ended December 31, 2013).
|
|
|
|
10.58
|
|
Consulting Agreement, between Cancer Genetics, Inc. and R.S.K. Chaganti, dated February 19, 2014 (incorporated by reference to Exhibit 10.67 of the Company's Annual Report on Form 10-k for the year ended December 31, 2013).
|
|
|
|
10.59
|
|
Employment Agreement, between Cancer Genetics, Inc. and Edward J. Sitar, dated March 17, 2014 (incorporated by reference to Exhibit 10.69 of the Company's Annual Report on Form 10-K for the year ended December 31, 2013).
|
|
|
|
10.60
|
|
Credit Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated April 1, 2014 (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K filed on April 4, 2014 with the Securities and Exchange Commission).
|
|
|
|
10.61
|
|
Revolving Line of Credit Note, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated April 1, 2014 (incorporated by reference to Exhibit 10.2 of the Company’s current report on Form 8-K filed on April 4, 2014 with the Securities and Exchange Commission).
|
|
|
|
10.62
|
|
Consulting Agreement, between Cancer Genetics Inc. and Equity Dynamics, dated November 6, 2014 and effective as of April 1, 2014 (incorporated by reference to Exhibit 10.4 of the Company’s quarterly report on Form 10-Q for the period ended September 30, 2014 with the Securities and Exchange Commission).
|
Exhibit
No.
|
|
Description
|
|
|
|
10.63
|
|
Security Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated November 12, 2014 (incorporated by reference to Exhibit 10.5 of the Company’s quarterly report on Form 10-Q for the period ended September 30, 2014 with the Securities and Exchange Commission).
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10.64
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|
First Amendment to Credit Agreement, between Cancer Genetics, Inc. and Wells Fargo Bank, N.A., dated November 12, 2014. (incorporated by reference to Exhibit 10.6 of the Company’s quarterly report on Form 10-Q for the period ended September 30, 2014 with the Securities and Exchange Commission).
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10.65
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|
Loan and Security Agreement, between Cancer Genetics, Inc. and Silicon Valley Bank, dated May 7, 2015.(incorporated by reference to Exhibit 10.1 of the Company’s quarterly report on Form 10-Q for the period ended March 31, 2015 with the Securities and Exchange Commission).
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10.66
|
|
Amended and Restated Asset Purchase Agreement By and Between Response Genetics, Inc. a Delaware Corporation, and Cancer Genetics., a Delaware Corporation, dated as of August 14, 2015 (incorporated by reference to the Company's current report on Form 8-K filed on August 21, 2015).
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10.67
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|
2011 Equity Incentive Plan, as amended and restated effective May 14, 2015, filed as Exhibit 10.1 to Form S-8 filed on July 28, 2015 (File Number 333-205903) and incorporated herein by reference.
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|
10.68
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|
Employment Agreement between Dr. Shaknovich and Cancer Genetics, Inc., effective as of July 1, 2015.(incorporated by reference to the Company’s current report on Form 8-K filed on July 7, 2015).
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10.69
|
|
Controlled Equity Offering
SM
Sales Agreement, dated July 15, 2015, by and between Cancer Genetics, Inc. and Cantor Fitzgerald & Co. (incorporated by reference to the Company’s current report on Form 8-K filed on July 16, 2015).
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10.70
|
|
Form of Warrant Agreement of Cancer Genetics, Inc. (corrected) (incorporated by reference to Exhibit 4.1 of the Company’s quarterly report on Form 10-Q for the period ended September 30, 2015 with the Securities and Exchange Commission).
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10.71
|
|
Office Lease, between Response Genetics, Inc. and Health Research Association, dated September 16, 2014 (incorporated by reference to the Company’s annual report on Form 10-K for the year ended December 31, 2015 with the Securities and Exchange Commission).
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10.72
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|
Tenth Amendment to Office Lease, between Response Genetics, Inc. and University of Southern California, dated June 30, 2015 (incorporated by reference to the Company’s annual report on Form 10-K for the year ended December 31, 2015 with the Securities and Exchange Commission).
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10.73
|
|
Consent and First Amendment to Loan and Security Agreement, between Cancer Genetics, Inc. and Silicon Valley Bank, dated January 28, 2016 (incorporated by reference to Exhibit 10.73 to the Company’s annual report on Form 10-K for the year ended December 31, 2015, filed on March 10, 2016).
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10.74
|
|
Form of Securities Purchase Agreement, dated May 19, 2016, by and between Cancer Genetics, Inc. and various purchasers named therein (incorporated by reference to Exhibit 10.1 to the Company’s current report on Form 8-K filed with the Securities and Exchange Commission on May 20, 2016).
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10.75
|
|
Engagement Letter between Cancer Genetics, Inc. and Rothman & Renshaw, a unit of H.C. Wainwright & Co., LLC, dated as of May 19, 2016 (incorporated by reference to Exhibit 10.2 to the Company’s current report on Form 8-K filed with the Securities and Exchange Commission on May 20, 2016).
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|
10.76
|
|
Eleventh Amendment to Lease Agreement, dated June 10, 2016, between University of Southern California and Cancer Genetics, Inc. (incorporated by reference to Exhibit 10.1 of the Company's quarterly report on Form 10-Q for the period ended June 30, 2016).
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|
10.77
|
|
Employment Agreement of John Roberts, dated June 27, 2016 (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K filed on June 30, 2016).
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|
|
10.78
|
|
Form of Securities Purchase Agreement, dated September 8, 2016, by and between Cancer Genetics, Inc. and various purchasers named therein (incorporated by reference to Exhibit 10.1 to the Company’s current report on Form 8-K filed with the Securities and Exchange Commission on September 9, 2016).
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|
|
10.79
|
|
Engagement Letter between Cancer Genetics, Inc. and Rothman & Renshaw, a unit of H.C. Wainwright & Co., LLC, dated as of September 8, 2016 (incorporated by reference to Exhibit 10.2 to the Company’s current report on Form 8-K filed with the Securities and Exchange Commission on September 9, 2016).
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|
|
|
10.80
|
|
Amendment, dated as of October 11, 2016, to Amended and Restated Cancer Genetics, Inc. 2011 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s current report on Form 8-K, filed with the Securities and Exchange Commission on October 12, 2016).
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10.81*
|
|
Amended and restated loan and security agreement with Silicon Valley Bank dated as of March 22, 2017.
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|
10.82*
|
|
Loan and security agreement with Partners for Growth IV, L.P. dated as of March 22, 2017.
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|
10.83*
|
|
Form of Warrant issued to lenders dated March 22, 2017.
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|
10.84*
|
|
Release, dated February 3, 2017, between Edward Sitar and Cancer Genetics, Inc.
|
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21.1*
|
|
Subsidiaries of Cancer Genetics, Inc.
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23.1*
|
|
Consent of RSM US LLP.
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24.1
|
|
Power of attorney (included on the signature page).
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|
|
31.1*
|
|
Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities and Exchange Act of 1934, as amended.
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|
31.2*
|
|
Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities and Exchange Act of 1934, as amended.
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|
32.1**
|
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.2**
|
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
101*
|
|
The following financial statements from this annual report on Form 10-K of Cancer Genetics, Inc. for the year-ended December 31, 2016, filed on March 23, 2017, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations, (iii) the Consolidated Statements of Cash Flows, (iv) the Consolidated Statements of Stockholders' Equity and (v) the Notes to the Consolidated Financial Statements.
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|
|
*
|
Filed herewith.
|
**
|
Furnished herewith.
|
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