Cgix presentation red chip

RedChip Global Conference

Company & Portfolio Update

Wednesday, October 15, 2014

Company & Portfolio Update | 2014 Cancer Genetics, Inc. | www.cancergenetics.com

Forward-Looking Statement

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 or Gentris, 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 related to

integration of the acquisitions of Gentris and BioServe and the realization of the currently anticipated

benefits, 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

Form 10-K for the year ended December 31, 2013 and 10-Q for the quarter ended June 30, 2014 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.

http://www.cancergenetics.com/












Who We Are…A Brief Overview of Our Business

3

Develop and commercialize unique, genomic tests for

comprehensive assessment and personalization of cancer

Provide this for areas of high unmet need and with a business

model centered around providing these tests as a service to

both clinical centers and hospitals as well as for the biotech

and pharma companies

Business Focus

Locations in New Jersey, North Carolina, India and China with

170 employees globally

Agreements with Roche, Gilead, Astra Zeneca & other

biotechs

Joint Venture with Mayo Clinic in NGS, OncoSpire Genomics

16 research collaborations with leading institutions

Six launched products

Business Basics












Clinical Biopharma

4

$6 Bn $2.5 Bn

$0.4 Bn

$1 Bn

$1 Bn

N/A

US

India

China


We Are Positioned To Be The Leader In Attractive

Markets With Significant Needs In Oncology












Our Core Areas of Expertise – Multiple Products Launched

5 Company & Portfolio Update | 2014 Cancer Genetics, Inc. | www.cancergenetics.com













Validation & Collaboraton With Leading Academic &

Research Partners Is The Backbone Of Our Unique Model












Proprietary Programs Drive Value for Both Biotech & Pharma Clients and the Clinical Community

CGI Is Uniquely Positioned From Bench to Bedside

Discovery

Biopharma

Clinical













Unique Footprint To Be A Global Partner in the

Personalization of Cancer Treatment

~170 People Focused on Oncology Genomics & Biomarkers For The Personalization of Medicine

Rutherford, NJ

18,000 sq. ft.

Raleigh, NC

28,000 sq. ft.

Hyderabad, India

14,000 sq. ft.

Shanghai, China

4,000 sq. ft.













Major Drivers for our Proprietary Programs

Is There Unmet Patient Need

Is It Unique & Can It Drive An “IP”-Ready Position

Can We Leverage The Existing, Routine Sample

Can We Validate & Collaborate w. Major Research Centers

Offer As A Part Of Our “Complete” Programs













6 Proprietary Diagnostic Products Commercially Launched & In Market

1


Incidence Indication

Hematologic Cancers

106,770 (Annual New Cases, Global)

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma


Diffuse Large B-Cell Lymphoma


Follicular Lymphoma


Mantle Cell Lymphoma

Urogenital Cancers


Kidney Cancer

HPV-Associated Cancers (FHACT®)

1,750,000 (Annual New Cases, US)

HPV-Associated Cervical Cancer

Over 2.3 Mn Combined Annual New Cases Globally












Product Pipeline

1


Research &

Discovery

Clinical

Development

Commercial

Development

Launch &

Market Entry

Indication

Development Stage

Hematologic Cancers

Multiple Myeloma

Comprehensive Myeloid Panel [NGS-based]

Comprehensive CLL Panel [NGS-based]

UroGenital Cancers

Bladder Cancer

Comprehensive Renal Panel [NGS-based]

Cervical Cancer

HPV-Associated Cancers (FHACT®)

Head & Neck Cancer












Cervical cancer remains a public health challenge and

several unmet needs continue to emerge in the battle

In industrialized countries, screening programs are

VERY costly and NOT highly accurate. Colposcopy-guided biopsy cost ranges $600-1,200 and delays diagnosis

and treatment.

HPV testing does not make use of somatic genome and does not

necessarily indicate presence of cancer

2

Several tests are available but the need for less

invasive and better informed treatment exists

* Transparency Market Research

3

1 Cervical cancer remains a worldwide public health

challenge, especially in developing countries –

often diagnosed too late.

85% of incidence correspond to developing countries

Cervical cancer Dx test is estimated to reach USD 75 Mn

globally in 2018*.

GLOBOCAN 2012 (IARC)

WORLDWIDE

528,000 cases

diagnosed per year

266,000 deaths (7.5% all female cancer)

FHACT® | 2014 Cancer Genetics, Inc. | www.cgifhact.com | www.cancergenetics.com 4

http://www.cgifhact.com/




















FHACT® fits directly into today’s cervical cancer screening

workflow as an additional triage prior to colposcopy

Today, all these women are referred for colposcopy.

Doesn’t need

colposcopy now.

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.

Abnormal signal pattern

HPV+ women with abnormal or unclear liquid-based cytology.

Normal signal pattern

Unmet Clinical Need

Identify women with low grade

cervical/ undetermined lesions that will

progress to a higher grade versus

those that will regress.

CGI Solution

FISH-based HPV-Associated Cancer

Test

Include FHACT® as additional triage

before referral for colposcopy.

No resampling

Fewer women referred for

colposcopy

Reduced healthcare costs

13 FHACT® | 2014 Cancer Genetics, Inc. | www.cgifhact.com | www.cancergenetics.com





















FHACT® can aid in identifying women with markers of

high grade lesions (cervical cancer)

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 ultimately is

observed in about 75% of cervical cancers.[1-2]

Gains of 5p15, 20q13 & chromosome 7 share a similar pattern of

appearance in precancerous cytology specimens by FISH (40-

45% for 5p15 and 20q13, and 15% for chromosome 7).[3-4]

Performed on remnant liquid based cytology (LBC).

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

Gain at any of the FHACT® loci is detected in up to 89.5% of all

cervical cancers.[5]

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)

chro

mosom

e 3

chro

mosom

e 7

chro

mosom

e 5

chr

20

14

FHACT® Loci:

3q26 gain (red)

5p15 gain (green)

Cen7 (aqua)

20q13 gain (gold)

FHACT® | 2014 Cancer Genetics, Inc. | www.cgifhact.com | www.cancergenetics.com





















Renal Portfolio | 2014 Cancer Genetics, Inc. | www.cancergenetics.com

15,720 new

cases

4,600 deaths

Estimated

for 2014 [ACS]

Unmet Needs:

Risk stratification to identify patients most likely to have aggressive disease.

Therapy selection

Chronic Lymphocytic Leukemia (CLL)

Median age at diagnosis is 65 to 68 years

Overall median survival is 9 years

Approximately 10% of all adult hematologic malignancies

(40% of leukemias in individuals over 65 years of age)

Two roughly equal clinical subtypes: indolent & aggressive

15 Hematology Portfolio | 2014 Cancer Genetics, Inc. | www.cancergenetics.com

7-8x That Are Living

With CLL























Comprehensive Genomic Evaluation of CLL For Improved

Diagnosis and Prognosis

13q

loss 12

gain 1p

gain 4p

loss 5p

loss 6q

loss 7p

loss 7p

gain

18p

gain

18q

gain

19p

gain

17p loss

11q loss

2p gain

3q gain

7q loss

8p loss

8q gain

17q

gain

18p loss

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 Genomic Aberrations Reported

by FISH: by MatBA®-CLL/SLL:

4 20

85%

15% 23%

39%

FISH (Current Method)

38%

(CGI Method)

13q

loss 12

gain

17p

loss

11q

loss













Independent Validation Datasets: DFCI (124), HUMC (65)

Time to First Treatment (TTFT)

Time (months)

Time (months)

Pro

po

rtio

n

Su

rviv

ing

Pro

po

rtio

n T

reatm

en

t-

Fre

e

– 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)

Leukemia & Lymphoma – Houldsworth, et. al Sept. 18, 2013

Time (months)

TTFT: DFCI

Pro

po

rtio

n T

rea

tme

nt-

Fre

e

P<0.001

Good (n=63)

Intermediate (n=47)

Poor (n=14)

Time (months)

OS: DFCI

Pro

po

rtio

n S

urv

ivin

g

P=0.522

Good (n=63)

Intermediate (n=47)

Poor (n=14)

Time (months)

TTFT: HUMC

Pro

po

rtio

n T

rea

tme

nt-

Fre

e

P=0.039

Good (n=13)

Intermediate (n=34)

Poor (n=18)

Time (months)

OS: HUMC

Pro

po

rtio

n S

urv

ivin

g

P=0.044

Good (n=13)

Intermediate (n=34)

Poor (n=18)

[Jennifer Brown] [Anthony Mato]

Discovery: 288 specimens

Validation: 124, 65 specimens 17 Hematology Portfolio | 2014 Cancer Genetics, Inc. | www.cancergenetics.com












Significance of Current Prognostication Markers in CLL in

the B-Cell Receptor Signaling Pathway Inhibitor Era

B-Cell Receptor Signaling Pathway

Inhibitors

[Kanti Rai, Nicholas Chiorazzi,

Jacqueline Barrientos]

Zydelig [Idelalisib (PI3K-delta)]

FDA Approved For CLL in the

relapse setting when

considering Rituximab alone

Collaborative project in

progress at CGI

Inisights will be integrated into

our Complete CLL

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

Acquired Mutations during

therapy in BTK Gene (C481S),

PLCG2 (R665W)

Deletion of 8p

Gain of 3q













$1 M funded in 2013 to initiate Joint Venture & Another $1M in 2014

Up to $4 M in additional funding based on project milestones

Projects Have 12 to 30 month development horizon

Core operations based in Rochester, MN and leverage Mayo facilities

World class NGS facility

Best in class bioinformatics

Globally leading clinicians

Immediately integrated into care

Scientific leadership

Disease focus and stewardship

Commercial focus and management

Capital access and investment

19 OncoSpire Genomics | 2014 Cancer Genetics, Inc. | www.cancergenetics.com












OncoSpire Genomics:

Projects are Unique and Have High Value

20 OncoSpire Genomics | 2014 Cancer Genetics, Inc. | www.cancergenetics.com

1.6 million

new cases

200,000

new cases

20,920

new cases

Informed

Discovery

Clinical

Development

Commercial

Development

Market Entry

(with partners)

Lung Cancer

Multiple Myeloma

Follicular Lymphoma

Selected Projects Have Significant Clinical Value & May Yield Multiple Focused Panels to

Become the Standard of Care in NGS-Based Oncology Management












Multiple Myeloma

Two Essential Needs Can Be Met

21

Earlier, More Accurate, Cost-Effective Prediction of MM

Identify mutations that predict change from MGUS to MM

Provide Greater Certainty & Reduce Complexity of Diagnosis

Replaces cytogenetics, FISH and gene expression profiling

Two NGS-based tests will be developed to…

To target a major unmet need that is growing globally:

Identifying MGUSs that need follow-up & treatment and determining

best treatments for malignancies

1.

2.

OncoSpire Genomics | 2014 Cancer Genetics, Inc. | www.cancergenetics.com












Multiple Myeloma: Setting the New Standard with a

Focused NGS Panel

22

77 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

OncoSpire Genomics | 2014 Cancer Genetics, Inc. | www.cancergenetics.com












Strong History of Growth CGI Revenue & Clinical Volume Trends (2009 – 2013)


54% Full Year 2013 Revenue Growth

$1.67

$2.52

$3.02

$4.30

$6.61

2009 2010 2011 2012 2013

2,321

3,146 3,622

6,610

10,771

2009 2010 2011 2012 2013

Total Revenue ($Mn) Clinical Volume (Tests Processed)












Strong History of Growth Revenue & Clinical Volume Trends (Q2 Comparison 2012-2014)


Total Revenue ($Mn) Clinical Volume (Tests Processed)

$1,148

$1,832

$3,231

Q2, 2012 Q2, 2013 Q2, 2014

1,623

3,204

2,664

Q2, 2012 Q2, 2013 Q2, 2014

Combined

CGI & Gentris

Revenue












Summary Statement of Operations (1st Half Comparison 2012-2014)


Income Statement Item 1H, 2012 1H, 2013 1H, 2014 Combined 1H, 2014*

Revenue $1,983 $3,050 $2,942 $6,508

Gross Profit 74 701 149 1,781

Gross Margin (%) 3.7% 23.0% 5.1% 27.4%

Research & Development (R&D) 1,050 951 1,703 2,043

Sales & Marketing (S&M) 716 832 1,667 1,703

General & Administrative (G&A) 2,329 2,961 5,127 7,092

Operating Profit (Loss) (4,021) (4,043) (8,348) (9,056)

Net Income (Loss) (2,933)

(6,782)

(6,673)

(7,417)

$ in thousands

* The “Combined 1H, 2014” results are the aggregation of first half 2014 of both Cancer Genetics, Inc. and Gentris Corporation. The amounts may not be indicative of future results.

Actual 06/30/14

All Cash* $43,418

Stockholders’ Equity 40,463

$ in thousands

* All cash included $6,000 restricted to collateralize a credit line

Balance Sheet Information












Multiple Customer Types Provide Diversified Revenue Mix

With Covered Lives Already in Place


Selected Payors

Direct Bill Customer Types

Biotechs

Pharmas

Academic

Cancer Facilities

Community &

Regional Labs

72+ million covered lives through multiple payors:

18%

21%

58%

3%

Medicare

3rd Party

Insurance

Companies,

Hospitals

& Care

Facilities

Payor Revenue Mix 1H, 2014

Reimbursement Based Direct Bill / Pay Based

3rd Party Insurance

Medicare

1H, 2014

Probes

Companies, Hospitals

& Care Facilities












Consistent Achievement of Milestones Expected in

Coming Quarters


Increasing covered lives market access

through additional payers & health care

organizations

Launching multi-marker NGS panel for

lymphoid malignancies

Additional international agreements with life

science tools companies for DNA Probes

and product distribution in key geographies

MatBA® – Next phase of data and results

from Dana Farber and HUMC studies to

help support value and reimbursement

Pursuing CE approval for IVDD use of

FHACT® in E.U.

Additional news on biopharma partners &

relationships

Pursuing additional indications for

UroGenRA®-Kidney microarray

Close of BioServe transaction (Q3, 2014)

Migrated DNA-FISH Probe Manufacturing to India reducing cost, increasing capacity and improving

operational flexibility

Launched UroGenRA®-Kidney, a unique microarray for kidney cancer diagnosis in collaboration with

MSKCC

Collaborative Study of UroGenRA®-Kidney with Cleveland Clinic demonstrated 93% diagnostic

accuracy – announced results at the AACR 105th Annual Meeting

Launched FHACT® outside the U.S. in collaboration with the National Cancer Institute research

publication and in the U.S. as an LDT under CLIA

Promoted FHACT® at the ACOG Annual Meeting

Received CLIA Approval for MatBA®-MCL (Mantle Cell Lymphoma)

Finalized Agreement with Multiplan and Three Rivers which gave us access to 72+ million covered

lives

Launched OncoSpire Genomics – A Next Generation Sequencing Joint Venture with Mayo Clinic and

announced initial set of projects (lung cancer, multiple myeloma & follicular lymphoma)

Launched CALR Mutation Test – for the diagnosis of myeloproliferative neoplasms potentially

evolving into acute leukemia

Announced Multi-Year PathAdvantage Collaboration – for FHACT® (cervical cancer)

Partnered with AstraZeneca – CGI will provide biomarker-based Dx in Central America and the

Caribbean

Acquisition of Gentris Corporation – closed on July 16, 2014

Recent Accomplishments

Upcoming Milestones and Value Drivers












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 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

Raju Chaganti, Ph.D., FACMG Founder

• 35+ years in cancer research; 38 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)

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

John Pappajohn [Chairman of the Board] | Keith Brownlie, CPA | Edmund Cannon | Raju Chaganti, Ph.D.

Michael J. Welsh, M.D. | Franklyn Prendergast, M.D., Ph.D. | Paul Rothman, M.D. | Panna Sharma

Board of Directors

Officers & Management Team












Thank you.

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

Cancer Genetics, Inc.

Meadows Office Complex

201 Route 17 North

Rutherford, NJ 07070

(201) 528-9200

www.cancergenetics.com

mailto:[email protected]


















Investor Relations

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