E M P O W E R I N G P E R S O N A L I Z E D C A N C E R T R E A T M E N T CGIX (NASDAQ) September 19, 2013 Exhibit 99.1 |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 2 All statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Cancer Genetics, Inc. (The Company) products and services, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited, to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights and other risks discussed in the Company’s registration statement on Form S-1 and other reports filed with the Securities and Exchange Commission which is available for review at www.sec.gov. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the Company's business. The Company disclaims any intent or obligation to update these forward-looking statements. Forward-Looking Statement |
Hybrid business model providing proprietary genomic products, clinical cancer testing and clinical trial services for biotechs and pharmas Category continues to experience significant price-to-sales multiples and premium acquisition valuations Experienced management team, active board of directors, and committed, industry-leading scientific advisors Established multi-year track record of top-line growth with improving margins Portfolio of commercially available, IP-protected, revenue-creating products: microarrays, DNA panels and probes Established collaborations and partnerships with world-class institutions including J.V. with Mayo Clinic: OncoSpire Genomics 54% revenue growth first half 2013 over first half 2012 2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 3 Growth-Stage, Oncology-Focused, Personalized-Diagnostics Company |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 4 Personalize therapeutic plan and treatment options DIAGNOSIS PROGNOSIS THERANOSIS Our unique focus & approach supports the entire cancer care continuum Assist in patient outcome and disease management What drug(s) to give, how much, and when? What are my survival prospects? Do I have cancer and what type? Use genomics to provide an accurate and definitive typing of the cancer Gain newer, more accurate tools to assess a patient’s cancer and develop an informed treatment plan PHYSICIANS PATIENTS Receive faster and more accurate diagnoses, as well as more personalized oncology care PAYORS Benefit from cost-savings when oncologists receive the right information the first time, and from increased treatment effectiveness PHARMA See high value in personalized medicine – and targeted therapeutics require companion diagnostic tests Molecular Diagnostics are Changing our Understanding of Cancer While Providing New Tools to Diagnose & Treat Patients Integrated Molecular Diagnostic Testing Brings Benefits Across the Entire Oncology Ecosystem |
Phenotypic & Physical Examination Morphologic & Pathological Analysis Large & Multiple Specimens Required Significant Delays to Treatment Traditional Approach Biomarkers and Companion Diagnostics Genomic Analysis & Proprietary Algorithms Reduced Size and Number of Specimens Our Approach: Personalized Medicine Target For Tomorrow 25% Integrating & Delivering Genomic Information About a Patient’s Cancer Can Improve Care & Reduce Cost Situation Today Source: Clinical Trends in Molecular Medicine, Vol. 7, Issue 5 Success Rate Target Success Rate Improved Diagnoses & Treatment Plans 100% 2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 5 CGI’s Mission is to Personalize and Improve the Success Rate in Cancer Treatment |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 6 PROPRIETARY PRODUCTS CLINICAL SERVICES BIOPHARMA PARTNERSHIPS Proprietary molecular diagnostics & FISH probes Clinically validated IP-protected Sold globally Probe manufacturing leverages low-cost, high scale facility in India Differentiated and complete disease-focused solutions Superior turnaround times World-class expertise in genomics and cytogenetics Serving community hospitals and labs through unique Expand Dx™ program Biomarker and companion diagnostic development World-class genomics and bioinformatics Drug-specific and cancer- specific assays Comprehensive focus in hematologic and urogenital cancers Suite of Products and Services Provides Multiple Growth Drivers and Value to Multiple Parties: Clinical Community, Biopharma & Medtech Unique, Scalable and Multifaceted Business Model |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 7 Source: American Cancer Society 149,990 2013 Estimated New Cases (U.S.) Death Rate 36% Hematological: Lymphoma, Leukemia, M. Myeloma 376,310 2013 Estimated New Cases (U.S.) Death Rate 16% Urogenital: Kidney, Bladder & Prostate Gynecological: Cervical, Endometrial & Ovarian Ability to Impact Over 610,000 New Lives Annually in the U.S. 5 Products Launched in Target Segments Our Target Markets in Oncology Testing Comprise Over 610,000 New Lives Annually in the U.S. 84,140 2013 Estimated New Cases (U.S.) Death Rate 31% |
FHACT™ - Cervical* FHACT™- Head&Neck UGenRA™ - Cervical UGenRA™ - Endometrial UroGenRA™ - Kidney UroGenRA™ - Bladder UroGenRA™-Prostate MatBA ® - Chronic & Small Lymphocytic Leukemia MatBA ® - Diffuse Large B-Cell Lymphoma MatBA ® - Mantle Cell Lymphoma MatBA ® - FL MatBA ® - MM Research & Discovery Clinical Development Commercial Development Launch & Market Entry Clinical Collaboration & Validation Partners UGenRA™ - Ovarian * - Launched Outside U.S. As A Product 5 Proprietary Diagnostic Products Commercially Launched & In Market 2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 8 |
Source: Genzyme & Nature Source: National Cancer Institute, National Center for Health Statistics, SEER Dataset of Incidence & Mortality, FDA Identified Leukemia & Lymphoma Subtypes Incidence & Survival Rates for NHLs (US Only, per 100,000) Genomics-Based Tests like MatBA ® are Critical and Improve the Management and Cost of Hematologic Cancers 1 2 5 12 89 100 80 60 30 2 Number of Years Ago 11.1 12.6 15.5 18.5 20.0 19.7 20.5 21.2 5.6 6.2 7.1 7.9 8.7 8.2 6.9 7.3 1975 1985 1995 2005 Incidence Rate Survival Rate 2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 9 Despite Improved Cancer Care, Case Numbers for Hematologic Cancers are Still Rising |
Validated in Collaboration w/ Dr. Kanti Rai & Dr. Nicholas Chiorazzi (NSLIJ); 2 Datasets, 322 specimens Additional Validations being conducted w/ HUMC & Dana Farber; 2 Cohorts, 350+ specimens Favorable Intermediate Unfavorable Favorable/ Intermediate (no distinction) 38% of cases in our study have a favorable prognosis falling under "watch & wait" approach. 8% of cases with unfavorable prognosis missed by FISH and caught using MatBA ® -CLL/SLL. Impact on therapy selection & clinical management of CLL patients. Genomic Aberrations Reported by FISH: 4 Genomic Aberrations Reported by MatBA ® -CLL/SLL: 20 85% 85% 15% FISH 23% 39% 38% (Current Method) (CGI Method) 2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 10 MatBA ® -CLL/SLL Array-CGH Improves Risk Stratification & Outcome Prediction |
MatBA ® - CLL / SLL is a diagnostic tool and prognostic indicator for patient stratification and improved patient management Poor outcome = High risk Intermediate outcome = Intermediate risk Good outcome = Low risk Detection of specific genomic imbalance in CLL/SLL by MatBA ® -CLL/SLL correlates patient risk with time to first treatment (TTFT) and shorter overall survival (OS) Time to First Treatment (TTFT) Time (months) Time (months) – GOOD (n=74) – INTERMED (n=107) – POOR (n=47) – GOOD (n=74) – INTERMED (n=107) – POOR (n=47) P = 0.090 P = 0.001 P < 0.001 P = 0.010 Overall Survival (OS) Being actively used in clinical care, in clinical trials and in validation programs with Dana Farber, MSKCC and HUMC 20 key genetic events/sites classify CLL patients as having the potential for Patients classified as high risk showed a shorter time to first treatment (TTFT) compared to those classified as low or intermediate risk Patients classified as high risk had significantly shorter overall survival (OS) times than those classified as low or intermediate risk Provides additional risk stratification between low and intermediate risk patients, not currently available in other tests 2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 11 MatBA® Can Group Patients Into Risk Groups and Prognostication Classes From Leukemia & Lymphoma – Houldsworth, et. al Sept/Oct 2013 |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 12 Prospective ongoing percutaneous needle biopsy (n>50) MSKCC Approaching 100% classification between benign and malignant lesions J. Coleman (MSKCC) & E. Klein (Cleveland Clinic) Retrospective ongoing in-house FFPE validation (n>150) CCF Test to distinguish benign from malignant subtype In-silico validation (n>600) Tested to subtype UroGenRA™-Kidney Can Help Decide if Partial Kidney Removal Is Required and Guide Treatment Selection PROBLEM Men and women with renal masses often undergo unnecessary nephrectomy for accurate diagnosis and experience delay in treatment SOLUTION UroGenRA™ is designed to detect genomic aberrations in a single assay in percutaneous needle biopsies permitting accurate diagnosis and reduction in cost & time to treatment Clinical Benefits Include Reduction in Number of Highly Invasive Procedures, Time to Treatment Selection and Time to Treatment Initiation Demonstrated ability to diagnose pathologically “unclassifiable” biopsies prior to surgical intervention ccRCC(n=489) 91% pRCC(n=75) 97% chrRCC(n=65) 98% Subtype Specificity |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 13 Cervical cancer effects nearly 500,000 women annually with nearly 80% in developing countries. FHACT™ - A New Genomic Aid In The Screening & Management Of Cervical Cancer • Provides critical information which reduces unnecessary and costly colposcopy • Predicts the progression and associated risk of cervical cancer progression Global Validation Partners National Cancer Institute Georgia Health Sciences Univ. University of Iowa Kamineni Hospital Genomic Amplification By Disease Category 90% Regress to Normal Grade Decreased Risk for Cancer 10% Progress to Higher Grade Increased Risk for Cancer HPV+ Abnormal Cervical Lesions Source: Luhn et al., IPV Poster, 2012 www.cmdrc.com * - Launched Outside U.S. As A Product |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 14 IP Position and Detailed Global Strategy Strong and growing portfolio in molecular-focused patents for disease identification and stratification IP-based on unique algorithms across a broad group of chromosomal regions Validation of specific clinical endpoints that are associated with particular disease outcomes or decisions Filing and maintenance of trademark portfolio Panel for the Detection and Differentiation of Renal Cortical Neoplasms US 11/932,422 Europe 08844570.5 Methods of Analyzing Chromosomal Translocations Using Fluorescence In Situ Hybridization (FISH) US Issued Patent 7,585,964 US Issued Patent 7,964,345 Canada 2,447,320 Methods and Tools for the Diagnosis of Female Gynecological Cancers and Precancers US 61/581,350 Tool for Diagnosis and Prognosis of Mature B-Cell Neoplasms US 12/980,480 US 13/475,034 Europe 10803548.6 India 6657/DELNP/2012 Canada 2,785,656 Methods for Detecting Human Papilloma Virus- Associated Cancers US 13/227,027 US 13/474,111 PCT/US2011/050681 |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 15 Community Hospitals Regional Cancer Centers Oncologists and Pathologists Continue to growing sales force that calls on hospitals and regional laboratories Plan development of national footprint through Expand Dx™ Biotechnology Companies Pharmaceutical Companies Leverage clinical infrastructure and proprietary product portfolio for testing services that support clinical trials Expand sales emphasis of Select One™ Emerging Markets Enhance distributor base in select emerging economies Partner with leading local cancer care providers and hospitals to provide probes, arrays and clinical services Collaborate to create and validate microarrays and other proprietary products Accelerate launch of large scale studies Universities and Research Centers Target Markets Commercialization Strategy Large, Targeted Market Opportunities with Extensive Value Creation for Key Markets |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 16 Delivers better outcomes to community hospitals and laboratories Enables community hospitals to bring “state-of-the-art” genomic testing to patients Brings personalized medicine to the community hospital vs. just at academic and teaching hospitals Allows community hospitals to keep patients and treat them locally Improving care and quality is critical to maintaining reimbursement for community hospitals Source: American Hospital Association Expanding & Developing Cancer Care is a Top Priority for Hospital CEOs & CFOs 4,000 to 5,000 Community Hospitals & Laboratories in the U.S. 85% Of All U.S. Cancer Patients are Initially Diagnosed in Community Hospitals & Laboratories $600,000 - $800,000 USD in Testing Opportunity on Average per Hospital Unique Service Offering Developed to Enable Community Hospitals to Improve Cancer Outcomes & Treat Patients Locally |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 17 GROWTH IN CGI’s DIRECT BILL CLIENTS ($000) 21% 55% ONCOLOGY DRUGS ASSOCIATED WITH BIOMARKER(S) Source: Company Analysis and Management Estimates 2011 2016 $221 $684 $1,738 1H, 2011 1H, 2012 1H, 2013 Well-Positioned for Use in Clinical Trials & Companion Diagnostic Programs Clinical Trial Services Showing Strong Growth and Robust Pipeline |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 18 Comprehensive, biomarker-based patient profiling will help risk stratification and response monitoring Improved patient profiling will result in improved trial efficacy for Gilead Testing will occur across several methodologies, including flow cytometry, FISH, sequencing and mutation assays, and MatBA ® microarrays CGI provides biomarker driven insight regarding patient targeting and potential outcomes Trials cover both national and international locations with all patient specimens being processed in Rutherford, New Jersey CGIX Press Release: Cancer Genetics, Inc. Selected By Gilead Sciences, Inc. to Provide Clinical Trial Services for International Trials in Chronic Lymphocytic Leukemia Gilead is Currently Using a Comprehensive Panel of CGI Services & Proprietary Products in National & International Trials for Hematologic Cancers Highlights The Gilead Relationship Exemplifies the Significant Upside Potential of CGI’s Select One™ Offering |
Collaborations with Premier Cancer Research Institutions Leading Differentiated Research & Driving Product Adoption 2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 19 Research Collaboration/ Licensing Clinical Services Partnership Highlights Renal Cancer, DLBCL, MCL & FL Joint Venture Focused on Oncology & Next Generation Sequencing Cervical Cancer DLBCL CLL Cervical Cancer & DLBCL Cervical Cancer Kidney Cancer DLBCL, Head & Neck Cancers CLL |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 20 Well-Positioned and Growing Internationally Including in Emerging Economies International revenue comes from sale of oncology products (DNA-FISH probes, arrays) and services to emerging economies Expect exposure to increase to emerging economies through strong partnerships with Kamineni Life Sciences (India), Roche (Central America & Caribbean), and DASA (Brasil) We focus our efforts through partnerships to ensure compliance with local regulations and distribution issues Expanded distribution network with 4 new distributors covering 7 countries Continued focus on increasing international partnerships in 2013 and 2014 |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 21 Roche Partnership Expanding Market Presence Internationally CGI won a global RFP to help a strategic personalized medicine initiative for Roche Servicios (Latin America) Roche sends all patient samples to the Rutherford facility where they are catalogued and processed CGI interacts with both Roche and the hospital staff (pathologists, oncologists and nurses) and supports delivery of reports through an online HIPAA compliant portal Plans are in development to expand the relationship CGI will be providing genomic and biomarker testing services to 14 countries in Central America and The Caribbean. CGIX Press Release: Cancer Genetics, Inc. selected by Roche Servicios S.A. to provide services for the diagnosis and personalization of oncology treatment Highlights "Since the beginning, CGI understood our needs and requirements and most importantly, consistently delivered the service we required…allowing us to offer high quality results and in a very short time to our patients. This commitment with Roche vision and values to offer to patients the best service to improve their lives, has made CGI a true business partner." Alvaro Soto, Roche Servicios | Central America & Caribbean General Manager |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 22 Mayo Clinic Joint Venture Investing in the Future – OncoSpire Genomics JV to develop clinical diagnostic products and services on NGS platform(s) for select cancers Select three initial projects in key oncology categories by the SRC (Scientific Review Committee) CGI commits up to $6 M over initial three year period (2013 to 2015-16 expected) Mayo commits to “in-kind” services and support, use of facilities, NGS capabilities and patient samples Joint Venture is exclusive in the project areas selected by CGI & Mayo Next Generation Sequencing in Oncology CGIX Press Release: Mayo Clinic Forms Joint Venture with Cancer Genetics Highlights The Value and Focus of Next Generation Sequencing is Moving from Platforms to Clinically Relevant, Disease-Specific Applications |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 23 Strong History of Growth CGI Revenue & Clinical Volume Trends (2009 – 2013 thru 6 mos) $1.67 $2.52 $3.02 $4.30 $3.05 2009 2010 2011 2012 2,321 3,146 3,622 6,610 5,115 2009 2010 2011 2012 1H-2013 Total Revenue ($Mn) Clinical Volume (Tests Processed) 1H-2013 Trailing 12 Months Revenue is $5.4 Mn |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 24 2012 2013 Strong History of Growth - Revenue & Clinical Volume Trends (Quarterly Comparison 2012 vs. 2013) Total Revenue ($000) 1 Quarter 2013 2012 2 Quarter Grants* Grants* Clinical Volume (Tests Processed) 2012 2013 1 Quarter 2013 2012 2 Quarter Note: Approx. 90% Growth 2 Quarter 2013 vs. 2012, Excluding Grants 46% 60% 97% 19% st nd st nd $835 $1,148 $1,218 $1,832 1,610 1,623 1,911 3,204 * Grants Q1,2012: $10K **Grants Q2,2012: $185K nd |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 25 Summary Statement of Operations (2009-2013 thru 6 mos) Income Statement Item 2009 2010 2011 2012 1H-2013 Revenue $1,666 $2,522 $3,019 $4,302 $3,050 Gross Profit (866) (995) (98) 373 701 Gross Margin (%) (52%) (39%) (3%) 9% 23% Research & Development (R&D) 1,336 1,167 2,074 2,112 951 Sales & Marketing (S&M) 239 716 1,574 1,399 832 General & Administrative (G&A) 1,845 3,446 4,439 4,503 2,961 Operating Profit (Loss) (4,286) (6,323) (8,185) (7,641) (4,043) Net Income (Loss) (7,328) (8,407) (19,887) (6,666) (6,782) $ in thousands 2009 - 2012 audited |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 26 Summary Statement of Operations (Quarterly & First Half Comparisons 2012 vs. 2013) Income Statement Item Q2 2012 Q2 2013 % 1H 2012 1H 2013 % Revenue $1,148 $1,832 60% $1,983 $3,050 54% Gross Profit 62 553 +100% 74 701 +100% Gross Margin (%) 5% 30% +100% 4% 23% +100% Research & Development (R&D) 527 456 (13%) 1,050 951 (9%) Sales & Marketing (S&M) 376 447 19% 716 832 16% General & Administrative (G&A) 1,393 1,384 (1%) 2,329 2,961 27% Loss From Operations (2,234) (1,734) 22% (4,021) (4,043) (1%) $ in thousands |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 27 Summary Balance Sheet Actual 06/30/13 Pro Forma (A) Cash & Cash Equivalents $1,941 $12,933 Total Assets 6,456 17,303 Total Liabilities 13,325 9,681 Stockholders’ (Deficit) Equity (6,869) 7,622 $ in thousands (A) Pro Forma basis gives effect to (i) the receipt of net proceeds of approximately $13.5 MM from the sale of 1,500,000 shares of common stock at $10.00 per share, less offering expenses in our secondary offering which closed on August 19, 2013, (ii) the repayment of outstanding indebtedness of approximately $3.5 MM, and (iii) the receipt of additional net proceeds of approximately $976,000 from the sale of 105,000 shares of common stock at $10.00 per share less offering expenses pursuant to the partial exercise of the underwriters’ over-allotment option on September 5, 2013. |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 28 Gross Profit Margin Highlights of Initiatives Manufacturing in India (Probes) Increased automation Process improvement and innovation Capacity utilization Leveraging cloud for scale in IT, data storage and clinical operations Developing innovative model for doing remote genetic analysis in India (52%) (39%) (3%) 9% 23% (1,000) (800) (600) (400) (200) 0 200 400 600 800 2009 2010 2011 2012 1H-2013 2009-2012 audited Consistent Focus on Gross Profit Improvements Additional Efforts Focused Operationally in US & India |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 29 Payor Revenue Mix 2013 (1H, 2013) Selected Payors Direct Bill Customer Types Reimbursement Based Direct Bill / Pay Based Insurance Companies Medicare Companies, Hospitals & Care Facilities Grants, Royalty & Other Pharmas 1H, 2013 Multiple Customer Types Provide Diversified Revenue Mix With Covered Lives Already in Place 57 million covered lives through multiple payors: Biotechs Academic Cancer Facilities Community & Regional Labs |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 30 Experienced and Focused Management and Boards Scientific Advisory Board Andrea Califano, Ph.D. Chairman of the Columbia Initiative for Systems Biology Associate Director for Bioinformatics, Herbert Irving Comprehensive Cancer Center Timothy A. Chan, M.D., Ph.D. Principal Investigator, Human Oncology and Pathogenesis Program at Memorial Sloan-Kettering Cancer Center Riccardo Dalla-Favera, M.D. Director, Institute for Cancer Genetics at Columbia University Hans-Guido Wendel, M.D. Principal Investigator, Cancer Genetics Laboratory at Memorial Sloan-Kettering Cancer Center Vundavalli V. Murty, Ph.D. Director, Cancer Cytogenetic Laboratory and Molecular Pathology at Columbia University Andrew D. Zelenetz, M.D., Ph.D. Chief of Lymphoma Service and Head of Molecular Hemo- Oncology Laboratory, Department of Medicine at MSKCC Raju Chaganti, Ph.D., FACMG Founder & Chairman 35 years in cancer research; 37 at MSKCC Major discoveries in cancer genomics Published 350+ articles, 4 patents Panna Sharma President & CEO 15+ years as advisor to global life science & healthcare cos. Founded TSG Partners Chief Strategy Officer, iXL (IIXL) Elizabeth Czerepak Chief Financial Officer 9 yrs as biotech VC; 18 yrs in pharma finance & deal making JPMorgan, Bear Stearns Health Innoventures, BASF, Roche, Merck Jane Houldsworth, Ph.D. Vice President of R&D 25 years in translational oncology research Published 50+ articles, 4 patents NIH grantee Raju Chaganti, Ph.D. | Keith Brownlie | John Pappajohn | Franklyn Prendergast, M.D., Ph.D. Panna Sharma | Edmund Cannon | Andrew Pecora, M.D. | The Honorable Tommy G. Thompson Board of Directors Officers & Management Team |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 31 Strong, Commercially-Focused News Flow & Consistent Achievement of Milestones Expected in Coming Quarters Increasing covered lives market access through additional payers and health care organizations Launching multi-marker NGS panel for leukemia and lymphomas Additional international agreements with life science tools companies for DNA Probes and product distribution in key geographies UroGenRA™ Kidney – Next phase of data and results from Cleveland Clinic collaboration MatBA ® – Next phase of data and results from Dana Farber and HUMC studies to help support value and reimbursement CE Approval for FHACT™ – Allows for IVDD use in E.U. Additional news on biopharma partners and relationships Announcing initial set of projects and launch plans for OncoSpire Genomics Upcoming Milestones & Value Drivers Accelerating market traction – over 50% quarter to quarter growth in 2013 and 60% over same quarter last year Launched UroGenRA™ – Kidney, a unique microarray for kidney cancer diagnosis and treatment selection in collaboration with MSKCC Launched FHACT™ outside the U.S. in collaboration with the National Cancer Institute research publication Received CLIA Approval for MatBA ® – MCL (Mantle Cell Lymphoma) Finalized Agreement with Multiplan which gave us access to 57 million covered lives Launched OncoSpire Genomics – A Next Generation Sequencing Joint Venture with Mayo Clinic Recent Accomplishments |
For further information, please contact us at ir@cancergenetics.com Cancer Genetics, Inc. Meadows Office Complex 201 Route 17 North Rutherford, NJ 07070 (201) 528-9200 www.cancergenetics.com |
Appendix |
MatBA ® -CLL/SLL resolved the prognostic discrepancy and confirmed high risk of poor outcome Clinician could then consider a more aggressive route of treatment for patient Allowed physician to better manage care and provide a more personalized treatment plan Gain of 2p & 19, loss at 6q poor outcome Biomarkers not assessed by other methods Comprehensive Genomic Assessment Conflicting Previous Prognoses FISH favorable/intermediate outcome (13q loss) Molecular poor outcome (IGHV status: unmutated) Contradictory Prognoses Left a Key Question: How to Best Manage & Treat This Patient’s Leukemia? CASE #174 MatBA ® -CLL/SLL Delivers Clear Value in Personalization of Leukemia Treatment – Clinical Case Study MatBA ® -CLL/SLL Can Favorably Impact Quality of Care and Reduce Healthcare Costs Due to Earlier and More Accurate Molecular Prognosis 2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 34 |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 35 Absence of chromosomal instability is consistent with low risk of progression to a higher grade Clinician can decide not to refer patient for immediate colposcopy Clinician can choose to put patient under active surveillance with follow-up in 6 months (-) for gain of 3q26, 5p15, 20q13 & Cen7 in 2,000+ cells scanned No chromosomal instability detected No resampling required DNA FISH Probe Screening Assay Pap Smear Classified as LSIL (low grade) Low grade cervical lesions may regress (~90%) or progress (~10%) Patients are typically referred for colposcopy procedure (1M+ /year) Will The Patient’s Low- Grade Cervical Lesion Progress to a Higher Grade, or Regress? CASE #021 FHACT™ Serves as an Additional Triage Step to Reduce Invasive Procedures & Healthcare Costs and Can Also be Applied to Other HPV-Associated Cancers FHACT™ Fits Directly into Today’s Cervical Cancer Screening Workflow as Additional Triage – Clinical Case Study |
2013 Cancer Genetics, Inc. | NASDAQ: CGIX | 36 Existing CGI Capabilities DNA-FISH Probe Low Resolution (~1-2Mb) Mid-High Market Maturity Value: High in established markets and growing in emerging markets High Resolution (~1-2kb) Low-Mid Market Maturity Value: Growing in established and more mature healthcare economies Sequence Fragment & Hybridize to Microarray Analyze Natural Extension of Technologies Used to Genomically Assess Cancer DNA Next Generation Sequencing Very High Resolution (1-2 nucleotides) Emerging Market Value: High in research but clinical value still emerging. First mover advantage in application development is critical The Next Step Expanding Proprietary Capabilities Across Full Range of DNA Detection Methodologies DNA Microarray |