cancer genetics, inc. nasdaq (cgix) · investor presentation | 2015 cancer genetics, inc. | |...

Investor Presentation May 2015

Cancer Genetics, Inc. Nasdaq (CGIX)

Investor Presentation | 2015 Cancer Genetics, Inc. | www.cancergenetics.com | @Cancer_Genetics 2

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development and potential opportunities for Cancer Genetics, Inc. 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, risks of cancellation of customer contracts or discontinuance of trials, risks that anticipated benefits from acquisitions will not be realized, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual property rights and other risks discussed in the Company's Forms 10-K for the year ended December 31, 2014 and 10-Q for the quarter ended March 31, 2015 along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics disclaims any obligation to update these forward-looking statements.

Forward-Looking Statement


Fact Sheet

Market Cap $110.08 Mn

Stock Price $11.29 [6/04/2015]

Ticker Symbol Nasdaq: CGIX

Qtrly Revenue (yoy) 117.6%

Total Cash $28.6 Mn

Facilities • Rutherford, NJ • Raleigh, NC • Hyderabad, India • Shanghai, China

18,000 sq. ft. 28,000 sq. ft. 14,000 sq. ft. 3,000 sq. ft.

Clients • Cancer Centers • Physician Offices • Research Orgs.

• Hospitals • Biotech • Biopharma

Products 9 Launched Products Patents 8 US Issued Patents

Cancer Genetics, Inc.

*Financial data as of 5/12/2015


Recent Highlights 2014-2015

§  Agreement with Three Rivers Provider Network expanded

§  FHACT® partnership with PathAdvantage

§  Partnership with AstraZeneca to provide biomarker & MDx testing

§  Biopharma contracts increased to $30 Mn+

§  NYS licensure for FHACT®

§  Agreement with America’s Choice Provider Network®

§  Focus::CLL™ selected for use in global clinical trial by leading biotech company

§  Acquisition of Gentris Corporation

§  Acquisition of BioServe India

§  Collaborative kidney cancer study with Cleveland Clinic results announced

§  Collaborations with Keck Medicine of USC & Beth Israel Deaconess Medical Center for diffuse large B-cell lymphoma

§  Next Gen Sequencing Collaboration with Columbia University for myelodysplastic syndromes & acute myeloid leukemia

§  Multi-Year Collaboration with Moffitt Cancer Center for genomics-based prediction of chemotherapy side effects

Acquisitions Research

Collaborations Business Growth

§  Awarded additional kidney cancer patent for UroGenRA®-Kidney

§  Awarded two cervical cancer patents for FHACT®

§  Launch of MatBA®-FL & MatBA®-MCL for follicular lymphoma & mantle cell lymphoma

§  Launch of CALR mutation test for acute leukemias & myeloproliferative neoplasms

§  Upgraded MatBA®-CLL/SLL algorithm for patient stratification; add’l CLIA & NYS Licensure

§  Launch of Focus::CLL™, Focus::Myeloid™, & Focus::Hotspot™ NGS panels

Product Launches Patents


Business Overview

8 Genomic Tests Launched

Research & Development Biotech/Biopharma

3,622 5,946 6,871

11,912

2011 2012 2013 2014

Clinical Test Volume (2011-2014)

17 Current Research Collaborations

Clinical Laboratory

NGS Panel Development:

Contracts with 6 of the top 10 pharma companies

Hematologic Cancers:

Urogenital Cancers:

Cervical Cancer:

35% CAGR


Genomic Testing has Paved the Way for Significant Advancements in Diagnosis & Targeted Treatment Options

Comprehensive Report

Proprietary Products

Focused Oncology Lab

OUR INTEGRATED APPROACH TO MOLECULAR TESTING BRINGS BENEFITS ACROSS THE ENTIRE

ONCOLOGY ECOSYSTEM

DIAGNOSIS Do I have cancer and if so,

what type?

PROGNOSIS What course will my cancer take? What should I expect?

THERANOSIS What are my treatment

options? Which drug is the best fit for me?


We are Positioned to be the Oncology Diagnostics Partner of Choice in Attractive Markets

Investor Presentation | 2015 Cancer Genetics, Inc. | www.cancergenetics.com | @Cancer_Genetics

U.S.

China

India

$6 Bn

$1 Bn

N/A

Clinical

$2.5 Bn

$0.4 Bn

$1 Bn

Biopharma


Major Drivers for our Proprietary Programs

Is there an unmet patient need?

Is it unique & can it drive an IP-ready position?

Can we leverage the existing routine sample?

Can we validate and collaborate with major research centers?

Can it be offered as part of our Complete™ programs?

1

2

3

4

5


Eight US Patents Awarded

7 Proprietary Diagnostic Products Addressing 1.2 Mn Cases Globally Launched & in Market

Hematologic Cancers Cases per Year (global) CGI Test

Chronic Lymphocytic Leukemia 106,770 Focus::CLL™, MatBA®-CLL/SLL

Diffuse Large B-Cell Lymphoma 142,360 MatBA®-DLBCL

Follicular Lymphoma 62,300 MatBA®-FL

Mantle Cell Lymphoma 17,795 MatBA®-MCL

Urogenital Cancers Cases per Year (global) CGI Test

Kidney Cancer 340,000 UroGenRA®-Kidney

Cervical Cancer Cases per Year (global) CGI Test

Cervical Cancer 528,000 FHACT®


Significant Progress in Targeted NGS Panel Pipeline

* Oncospire Genomics: a joint venture with Mayo Clinic

RESEARCH & DISCOVERY CLINICAL DEVELOPMENT COMMERCIAL DEVELOPMENT LAUNCH & MARKET ENTRY

FOCUS::CLL™

FOCUS::MYELOID™ (IN COLLABORATION WITH ILLUMINA)

FOCUS::LYMPHOID™

MULTIPLE MYELOMA (VIA ONCOSPIRE*)

FOLLICULAR LYMPHOMA (VIA ONCOSPIRE*)

HEMATOLOGIC CANCERS

FOCUS::RENAL™

UROGENITAL CANCERS

FOCUS::HOTSPOT™ (INITIAL LAUNCH IN INDIA)

LUNG CANCER (VIA ONCOSPIRE*)

SOLID TUMOR

COMPREHENSIVE PHARMACOGENOMICS PANEL

PHARMACOGENOMICS (PGX)

TEST IN MARKET

TEST IN MARKET

TEST IN MARKET

11 Investor Presentation | 2015 Cancer Genetics, Inc. | www.cancergenetics.com | @Cancer_Genetics

OncoSpire Genomics Developed by Cancer Genetics, Inc. and Mayo Clinic

§  World class NGS facility §  Best in class bioinformatics §  Immediately integrated into care

§  Disease focus and stewardship §  Commercial focus and mgmt §  Capital access and investment

SELECTED PROJECTS HAVE THE POTENTIAL TO BECOME CLINICAL STANDARD OF CARE IN NGS-BASED ONCOLOGY MANAGEMENT

§  Only Joint Venture by the Mayo Clinic in the Oncology space

§  Core operations leverage Mayo facilities in Rochester, MN

§  $1M funded in 2013 to initiate JV, $2M in 2014, up to $3M additional based on milestones

§  Projects with 12 to 30 month development horizon; Multiple Myeloma panel to launch in 2015

200,000 new cases

20,920 new cases

1.6 million new cases

Informed Discovery

Clinical Development

Commercial Development

Market Entry (with partners)

Multiple Myeloma

Follicular Lymphoma

Lung Cancer


Multiple Myeloma: Setting the New Standard with a Focused NGS Panel

A comprehensive NGS-based panel will be developed to…

To target a major unmet need growing globally:

Identifying MGUSs that need follow-up & Tx and determining best treatments for malignancies

Provide Greater Certainty & Reduce Complexity of Diagnosis àReplaces cyto, FISH & gene expression profiling 1.

2. Earlier, More Accurate, Cost-Effective Prediction of MM àIdentify mutations that predict change from MGUS to MM

•  88 genes selected for panel

•  DNA sequencing complete for first 60 samples

•  Analysis underway comparing 3 different analytical methods to determine best solution

•  In process of optimizing clinical laboratory design from extraction to reporting solution

•  3 papers in the publication process

•  2 international early-access collaborations established


Focus::CLL™ NGS Panel

§  Launched in Q4 2014

§  Unique targeted NGS panel with 7 biomarkers for diagnosis, prognosis and patient management

§  The only targeted NGS panel available for CLL/SLL

§  Selected for use in global clinical trial by a leading biotechnology company

§  18,200 new cases per year §  150,000 people living with the disease

Numbers Behind the Disease

§  Chronic Lymphocytic Leukemia (CLL) §  Small Lymphocytic Lymphoma (SLL)

Clinical Indications

(United States)

http://www.cancergenetics.com/laboratory-services/specialty-tests/focus-ngs/focuscll/


Focus::Myeloid™ NGS Panel

§  Launched in Q1 2015 §  Comprehensive NGS panel with 54 biomarkers that provides actionable information

for improved diagnosis, prognosis, and risk stratification

§  Delivers faster results on biomarkers in current diagnostic and treatment guidelines

§  Expands therapy options for patients with appropriate enrollment in clinical trials

§  Selected for use in multiple clinical trials

§  54,000 new cases per year §  274,000 people living with the disease

Numbers Behind the Disease

§  Acute myeloid leukemia (AML) §  Myelodysplastic syndrome (MDS) §  Myeloproliferative neoplasms (MPN)

Clinical Indications

(United States)

http://www.cancergenetics.com/laboratory-services/specialty-tests/focus-ngs/focusmyeloid/


MatBA®-CLL/SLL Drives Improved Management of Patients with Chronic Lymphocytic Leukemia (CLL)

Favorable/ Intermediate (no distinction)

Unfavorable 85%

15%

FISH 4 Genomic Aberrations

Risk stratification by FISH, classifies patients into only two groups:

§  Favorable/Intermediate (no distinction)

§  Unfavorable

38% of cases are favorable falling under "watch & wait" approach.

8% of unfavorable cases missed by FISH are caught by MatBA®-CLL/SLL. 23%

39%

38%

20 Genomic Aberrations Favorable

Intermediate

Unfavorable

MatBA®-CLL/SLL is both CLIA & NYS licensed to stratify patients into three distinct risk groups:

§  Favorable §  Intermediate §  Unfavorable


[Kanti Rai, Nicholas Chiorazzi, Jacqueline Barrientos]

Significance of Current Prognostic Markers in CLL in the B-Cell Receptor Signaling Pathway Inhibitor Era

Zydelig™ [Idelalisib (PI3K-delta)]

§  FDA Approved For CLL in the relapse setting when considering Rituximab alone

§  Collaborative project in progress at CGI

§  Insights will be integrated into our CLL Complete™

IMBRUVICA™ [Ibrutinib (BTK)]

§  FDA Approved for CLL with 17p loss and in the relapse setting where two prior therapies have failed

§  Genomic alterations associated with resistance Ø  Acquired Mutations during therapy in BTK

Gene (C481S), PLCG2 (R665W) Ø  Deletion of 8p Ø  Gain of 3q

B-CELL RECEPTOR SIGNALING PATHWAY INHIBITORS


Solution

UroGenRA®-Kidney Can Guide Management of Patients with Renal Masses and Appropriate Treatment Selection

Development of diagnostic algorithm §  >600 RCC malignant subtypes (in-silico: SNP) §  >100 malignant and benign renal neoplasms (in-house: aCGH & FISH)

Retrospective in-house FFPE validation (n>190) CCF diagnostic yield

diagnostic sensitivity to distinguish benign from malignant renal neoplasms sensitivity to distinguish malignant RCC subtypes

Prospective ongoing percutaneous core needle biopsy (n>50) MSKCC §  Demonstrated ability to diagnose pathologically “unclassifiable” biopsies prior to

surgical intervention

Men and women with renal masses often undergo unnecessary nephrectomy for accurate diagnosis and experience delay in treatment

Problem UroGenRA® will detect genomic aberrations in a single assay permitting accurate diagnosis (benign vs malignant, and malignant subtype) guiding appropriate management and treatment strategies

[C. Magi-Galluzzi and E. Klein]

[J. Coleman and J. Durack]


FHACT® Fits Directly into Today’s Cervical Cancer Screening Workflow

Today, all these women are referred for colposcopy.

Not referred for colposcopy

Referred for colposcopy

PROGRESS to a higher grade and increased risk for cancer within 10-30 years of the infection.

REGRESS within 2 years of the infection.

FHACT® Results: Normal

FHACT® Results: Abnormal

§  Today, all HPV+ women with abnormal

Pap results are referred for colposcopy §  Several cervical cancer tests are

available but the need for less invasive and better informed treatment exists

§  FHACT® helps triage before colposcopy

§  No resampling §  Fewer women referred for colposcopy §  Reduced healthcare costs


FISH-based HPV-Associated Cancer Test FHACT® assesses non-random genomic alterations associated with progression of lesion.

§  Gain of 3q26 (TERC) has been detected with increasing frequency in cervical lesions with increasing severity and is observed in about 75% of cervical cancers.[1-2]

§  Gains of 5p15, 20q13 & chr 7 share a similar pattern of appearance in precancerous cytology specimens by FISH (40-45%, 20q13, and 15% respectively).[3-4]

§  Performed on remnant liquid based cytology. §  Gain at any of the FHACT® loci is detected in up to 89.5% of all

cervical cancers.[5]

FHACT® presents the highest sensitivity on the market (4 loci).

1.  Heselmeyer-Haddad K, et al. (2005). Am. J. Pathol. , 166, 1229-1238

2.  Seppo A., et al. (2009) Gynecol Oncol, 114, 80-83 3.  Scotto, L., et al. (2008). Mol Cancer, 7, 58. 4. Luhn P, et al. (2013). Gynecol Oncol, 130, 595-600. 5. The Cancer Genome Atlas (TCGA) (http:/cancergenome.nih.gov)

FHACT® Can Aid in Identifying Women with Markers of High Grade Lesions (Cervical Cancer)

FHACT® Loci: §  3q26 gain (red)

§  5p15 gain (green)

§  Cen7 (aqua)

§  20q13 gain (gold)


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

Large, Targeted Market Opportunities

Commercialization Strategy Target Markets


•  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

$600,000 - $800,000 USD in Testing Opportunity on Average per Hospital

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

Unique Service Offering Developed to Enable Community Hospitals to Improve Cancer Outcomes & Treat Patients Locally


Strong Growth in Clinical Trial Contracts with Oncology Programs at Leading Biotech & Pharma Companies

Approximate expected future revenues under signed contracts with biotechnology and pharma customers for testing and services to support currently planned clinical trials.

CGI IS ACTIVELY PROVIDING TESTING, GENOMIC SERVICES, AND BIOMARKER SUPPORT FOR

December 2013 December 2012 December 2014 March 2015


Strong History of Growth Revenue Trends (2014 Year End and Q1 2015)

Year End Total Revenue ($Mn) Q1 Total Revenue ($Mn)

§  $10.2 Mn revenue, up 54% Yr./Yr. §  Biopharma revenue grew 112% Yr./Yr.

$[VALUE]

$[VALUE]

$[VALUE]

10.2

2011 2012 2013 2014

$

36% CAGR

2014 2013 2011 2012

§  $4.4 Mn revenue, up 206% Qtr./Qtr. §  Biopharma revenue grew 578% Qtr./Qtr.

$[VALUE]

$[VALUE]

$[VALUE]

$[VALUE]

Q1, 2012 Q1, 2013 Q1, 2014 Q1, 2015 Q1, 2015 Q1, 2014 Q1, 2013 Q1, 2012

53% CAGR


Summary Statement of Operations

Income Statement Item ($ in Thousands) Q1 2013 Q1 2014 Q1 2015 Revenue $1,219 $1,430 $4,370

Gross Profit 149 140 1,229

Gross Margin (%) 12% 10% 28%

Research & Development (R&D) 491 597 1,278

Sales & Marketing (S&M) 397 749 1,116

General & Administrative (G&A) 1,571 2,731 2,987

Operating Profit (Loss) (2,309) (3,936) (4,152)

Net Income (Loss) 2,360

(2,486) (4,278)

Balance Sheet Information Actual 03/31/15 All Cash* $28,612 Stockholders’ Equity 30,972 $ in thousands * All cash includes $6,300 of restricted cash.

$6,000 of that is now unrestricted as of May 7, 2015. (Cancer Genetics, Inc. 2014 YE 10Q, page 77)


Revenues by Category

76%

20%

4% Q1 2015

BIOPHARMA SERVICES

CLINICAL SERVICES

DISCOVERY SERVICES $10.2 Mn $4.4 Mn

§  Launched new NGS panels, including Focus::Myeloid™

§  Repositioning of Go-To Market Strategy to concentration on clinical sales

§  New research studies with leading cancer centers and academic institutions

§  Focus::Hotspot™ NGS panel for solid tumors adopted in multiple research programs in India

§  Selected to power molecular and biomarker testing for six clinical trials

§  Focus::CLL™ chosen for global clinical trial by leading biotechnology company

$3.3 M

$873 K

$166 K


Consistent Achievement of Milestones Expected in Coming Quarters

§  Increasing covered lives market access through additional payers & health care organizations §  Additional international agreements for FHACT® distribution and co-marketing partnerships in key geographies

§  Launching multi-marker NGS panel for lymphoid malignancies §  Multiple Myeloma NGS panel launch, Oncospire à Second half of 2015

§  Lymphoid, Myeloid and CLL Panels - Additional data and results to support clinical usage, patient value and payor coverage

§  FHACT® - Additional data from a study conducted in conjunction with NCI and more published papers focused on FHACT®, including a health economic study

§  Additional news on biopharma partners & relationships §  Major collaborations with US & Asia biopharma companies


Scientific Advisory Board Andrea Califano, Ph.D. Chairman of the Columbia Initiative for Systems Biology Associate Director for Bioinformatics, Herbert Irving Comp. Cancer Ctr

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

Vundavalli V. Murty, Ph.D. Director, Cancer Cytogenetic Laboratory and Molecular Pathology at Columbia University

Hans-Guido Wendel, M.D. Principal Investigator, Cancer Genetics Laboratory at Memorial Sloan-Kettering Cancer Center

Howard McLeod, PharmD Medical Director, DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center

Andrew D. Zelenetz, M.D., Ph.D. Chief of Lymphoma Service and Head of Molecular Hemo-Oncology Laboratory, Department of Medicine at MSKCC

Panna Sharma President & CEO •  15+ years as advisor to global life science & healthcare cos. •  General Manager of Oncospire Genomics, JV with Mayo Clinic •  Founded TSG Partners •  Chief Strategy Officer, iXL (IIXL)

Edward J. Sitar Chief Financial Officer & Treasurer •  30+ yrs in finance & deal making in the healthcare industry •  Healthagen, ActiveHealth Management, Cadent Holding, MIM Corporation

(Bioscrip), Vital Signs, Zenith/Goldline Pharmaceutical, Coopers & Lybrand

Jane Houldsworth, Ph.D. Vice President of R&D •  25+ years in translational oncology research •  Published 50+ articles, 4 patents •  NIH grantee

Rob Fannon Vice President of Operations •  10+ years operations, client management, molecular test & panel

development, and biorepository management •  Roche Molecular Systems, BioServe Biotechnologies, Ltd., Stansberry &

Associates Investment Research

John Pappajohn [Chairman] | Edmund Cannon | Raju Chaganti, Ph.D. | Geoffrey Harris

Howard McCleod, Pharm.D. | Franklyn Prendergast, M.D., Ph.D. | Panna Sharma | Michael J. Welsh M.D.

Board of Directors

Officers & Management Team

Experienced and Focused Management and Boards


•  Strong and growing portfolio in molecular-focused patents for disease identification & 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

Tool for Diagnosis and Prognosis of Mature B-Cell Neoplasms •  US Issued Patent 8,580,713 •  US Issued Patent 8,557,747 •  Europe 10803548.6 •  India 6657/DELNP/2012 •  Canada 2,785,656

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 – Foreign Counterpart Patent

Panel for the Detection & Differentiation of Renal Cortical Neoplasms •  US Issued Patent 8,603,948 •  US Issued Patent 8,716,913 •  Europe 08844570.5

Methods for Detecting Human Papilloma Virus-Associated Cancers

•  US Issued Patent 8,865,882 •  US Issued Patent 8,883,414 •  PCT/US2011/050681

Methods and Tools for the Diagnosis of Female Gynecological Cancers and Precancers

•  US 61/581,350

IP Position and Detailed Global Strategy

Thank you Nasdaq (CGIX)

CGI Headquarters Meadows Office Complex 201 Route 17 North, 2nd Fl. Rutherford, NJ 07070 Phone: +1 201-528-9200 Fax: +1 201-528-9235

RUTHERFORD, NJ Research Triangle Park 133 Southcenter Court, S.400 Morrisville, NC 27569 Phone: +1 919-465-0100 Fax: +1 919-465-0554

RALEIGH, NC #3-1-135 / 1A CNR Complex Mallapur Main Road, R.R. Dst. Hyderabad – 500 076, Telangana Toll-free: +91 040-2717-8178 Fax: +91 040-2717-8176

HYDERABAD, INDIA 781 Cai Lun Road, Room 803 Shanghai 201203 P.R. China Toll-free: +91 040-2717-8178 Fax: +91 040-2717-8176

SHANGHAI, CHINA

For further information, please contact us at [email protected]

cancer genetics, inc. nasdaq (cgix) · investor presentation | 2015 cancer genetics, inc. | |...

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