Revolutionizing Medicine through Pharmacogenomics

Phone: (919) 465-0100 | pharmadx@cgix.com

Date: November 20, 2014
Location: Bethesda, MD

  • Cancer Genetics will present two posters on diffuse large B-cell lymphoma (DLBCL), the most common form of B-cell cancers.
  • OncoSpire Genomics, Cancer Genetics’ joint venture with Mayo Clinic, to present on proprietary NGS-based panel for multiple myeloma (MM).

RUTHERFORD, N.J., November 17, 2014 (Globe Newswire) — Cancer Genetics, Inc. (Nasdaq: CGIX) (“CGI” or “the Company”), an emerging leader in DNA-based cancer diagnostics, announced today that it will present two posters on diffuse large B-cell lymphoma (DLBCL) at the 56th annual meeting of the American Society of Hematology (ASH) in San Francisco, CA.  A third poster on multiple myeloma (MM) will be presented by OncoSpire Genomics, CGI’s joint venture with Mayo Clinic.

The first poster, “Robust Assessment of Genomic Imbalance in Diffuse Large B-Cell Lymphoma Confirms Inferior Outcome Is Associated with Genomic Complexity and Identifies Potential Therapeutic Pathway Targets” (abstract 71186) will be presented Sunday, December 7 at 6:00 pm and will report the results of an investigation which correlated genomic complexity with outcome in DLBCL patients previously treated with RCHOP– the current frontline treatment for the disease. In addition to confirming that genomic complexity is associated with poorer survival in DLBCL patients, the study identified biological pathways in DLBCL that may represent potential therapeutic targets.

Cancer Genetics’ second poster, “Genomic Complexity in Diffuse Large B-Cell Lymphoma is Associated with p53 Expression and Inferior Survival” (abstract 74868) will report results from a collaboration with the University of Southern California’s Keck School of Medicine on Sunday, December 7, 2014 at 6:00 pm in the Moscone Center, West Building. The study found that expression of a specific biomarker (p53) was associated with underlying genomic complexity, and therefore poor prognosis. Investigators also found that loss of the TP53 locus marked another subset of DLBCL patients with poor survival independent of p53 expression.

DLBCL is the most common type of aggressive non-Hodgkin Lymphoma, accounting for approximately 40% of all B-cell malignancies.  An estimated 190,000 people in the United State are currently living with or are in remission from DLBCL, and approximately 20,000 new cases are diagnosed each year.

Despite excellent initial responses of DLBCL patients to current frontline immunotherapy (R-CHOP), only about 40% of patients are ultimately cured, with most relapses occurring within the first two to three years.

“Integrating the findings from examination of the DLBCL genome via profiling technologies with other biomarkers – such as those generated by immunohistochemistry – will increasingly be implemented in the routine diagnostic setting, and will enhance the overall role of diagnostics in the clinical management of DLBCL patients,” said Jane Houldsworth, Ph.D., vice president of research and development at CGI.

OncoSpire Genomics, the Company’s joint-venture with Mayo Clinic, will deliver an oral presentation showcasing the joint-venture’s proprietary NGS-based panel for multiple myeloma. “Development and Results of a Multiple Myeloma Specific Custom 77-Gene Mutation Panel for Clinical Targeted Sequencing” will be presented Sunday, December 7, 2014 at 4:30 pm.

About 24,000 new cases of multiple myeloma are diagnosed in the US each year. While a number of tests are currently used to diagnose MM, there remains significant need for more precise genomic tests to help diagnose, prognose, and guide treatment selection for this disease.

Representatives from Cancer Genetics will also be exhibiting at the conference at booth # 431.

About Cancer Genetics

Cancer Genetics Inc. is an emerging leader in DNA-based cancer diagnostics, servicing some of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict treatment outcomes. These cancers include hematological, urogenital and HPV-associated cancers. We also offer a comprehensive range of non-proprietary oncology-focused tests and laboratory services that provide critical genomic information to healthcare professionals, as well as biopharma and biotech companies. Our state-of-the-art reference labs are focused entirely on maintaining clinical excellence and are both CLIA certified and CAP accredited and have licensure from several states including New York State.

We have established strong research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute.

For more information, please visit or follow us:

  •  Internet: www.cancergenetics.com
  •  Twitter: @Cancer_Genetics
  • Facebook: www.facebook.com/CancerGenetics

Forward Looking Statements: This press release 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 the transaction will not close or, if it closes, will not realize 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 September 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.

Contacts
Investor Relations
Andrew McDonald Ph.D.
Life Science Advisors LLC
646-597-6987                                                                     

Media Relations
Paul Kuntz
RedChip Companies, Inc.
800-733-2447, ext. 105
paul@redchip.com

 Source: Cancer Genetics, Inc.

> CGI Recognized As One of North America’s Fastest Growing Companies Based on Revenue Growth.

RUTHERFORD, N.J., November 14, 2014 (Globe Newsire) — Cancer Genetics, Inc. (Nasdaq: CGIX) (“CGI” or “the company”), an emerging leader in DNA-based cancer diagnostics, today announced it ranked 303 on Deloitte’s Technology Fast 500™, a ranking of the 500 fastest growing technology, media, telecommunications, life sciences and clean technology companies in North America. CGI grew 296% percent as measured by revenues during this period.

Cancer Genetics’ chief executive officer, Panna Sharma, credits the company’s ability to develop and lauch targeted, proprietary genomic tests and its focus on the personalization of oncology treatment with the company’s 296% revenue growth. He said, “We are seeing extraordinary interest among oncologists and pathologists for targeted genomic information that has been validated with leading research institutions to improve diagnosis, and guide and monitor patient treatment. The pace at which new combination protocols and new molecular therapeutics are being adopted is driving more informed cancer care.  CGI is uniquely positioned as a partner in this era of precision medicine.”

“The companies ranked on the 2014 Deloitte Technology Fast 500 continue to set the bar for their industry higher each year,” said Eric Openshaw, vice chairman, Deloitte LLP and U.S. technology, media and telecommunications leader. “There are so many exciting products and smart thought leaders driving this list. We congratulate the Fast 500 companies and look forward to seeing them continue their momentum into 2015.”

“For 20 years, the Deloitte Fast 500 rankings have honored the innovation that is part of these companies’ DNA,” added Jim Atwell, national managing partner of the emerging growth company practice, Deloitte & Touche LLP. “We’re glad to be serving these high-growth companies, and helping the technology sector recognize the great strides and transformation these companies are making in their respective areas.”

“As we continue to grow through launches of proprietary test and selective acquisitions, we wil impact more patients, inform the outcomes of more trials, and aid in new discoveries in oncology.  With our expanded global footprint and demonstrated excellence in providing cutting-edge genomic testing, Cancer Genetics is quickly become the partner of choice to help personalize the treatment of cancer from bench to bedside” said Panna Sharma, President and CEO of Cancer Genetics.

Overall, 2014 Technology Fast 500™ companies achieved revenue growth ranging from 135 percent to 123,678 percent from 2009 to 2013, with an average growth of 1,640 percent.

About Deloitte’s 2014 Technology Fast 500™

Technology Fast 500, conducted by Deloitte LLP, provides a ranking of the fastest growing technology, media, telecommunications, life sciences and clean technology companies – both public and private – in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2009 to 2013.

In order to be eligible for Technology Fast 500 recognition, companies must own proprietary intellectual property or technology that is sold to customers in products that contribute to a majority of the company’s operating revenues. Companies must have base-year operating revenues of at least $50,000 USD or CD, and current-year operating revenues of at least $5 million USD or CD. Additionally, companies must be in business for a minimum of five years and be headquartered within North America.

About Cancer Genetics

Cancer Genetics Inc. is an emerging leader in DNA-based cancer diagnostics, servicing some of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict treatment outcomes. These cancers include hematological, urogenital and HPV-associated cancers. We also offer a comprehensive range of non-proprietary oncology-focused tests and laboratory services that provide critical genomic information to healthcare professionals, as well as biopharma and biotech companies. Our state-of-the-art reference labs are focused entirely on maintaining clinical excellence and are both CLIA certified and CAP accredited and have licensure from several states including New York State.

We have established strong research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute.

For more information, please visit or follow us:

  • Internet: www.cancergenetics.com
  • Twitter: @Cancer_Genetics
  • Facebook: www.facebook.com/CancerGenetics

Forward Looking Statements: This press release 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 the transaction will not close or, if it closes, will not realize 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 September 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.

Contacts
Investor Relations
Andrew McDonald Ph.D.
Life Science Advisors LLC
646-597-6987                                                  

Media Relations
Paul Kuntz
RedChip Companies, Inc.
800-733-2447, ext. 105
paul@redchip.com

Date: November 13 – 15, 2014
Location: National Harbor, MD

RUTHERFORD, N.J., November 13, 2014 (Globe Newswire) — Cancer Genetics, Inc., (Nasdaq: CGIX) an emerging leader in DNA-based cancer diagnostics, announced today that the company’s CEO, Panna Sharma, will present at the upcoming Canaccord Genuity Medical Technology & Diagnostics Conference. The event, which will be held at the Westin Grand Central in New York on Thursday, November 20, will profile over 80 public and private med-tech and diagnostic companies.

Mr. Sharma is scheduled to speak at 11:30 am EST.

A live webcast of the event will be available at http://www.wsw.com/webcast/canaccord16.

About Cancer Genetics, Inc.

Cancer Genetics Inc is an emerging leader in DNA-based cancer diagnostics, servicing some of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict treatment outcomes. These cancers include hematological, urogenital and HPV-associated cancers. We also offer a comprehensive range of non-proprietary oncology-focused tests and laboratory services that provide critical genomic information to healthcare professionals, as well as biopharma and biotech companies. Our state-of-the-art reference labs are focused on maintaining clinical excellence and are both CLIA certified and CAP accredited and have licensure from several states, including New York State.

We have established strong research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute.

For more information, please visit or follow us:

Forward Looking Statements: This press release 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 the transaction will not close or, if it closes, will not realize 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.

Contacts

Investor Relations                                         Media Relations
Andrew McDonald Ph.D.                               Paul Kuntz
Life Science Advisors LLC                             RedChip Companies, Inc.
646-597-6987                                                800-733-2447, ext. 105
paul@redchip.com

 RUTHERFORD, N.J., November 12, 2014  – Cancer Genetics, Inc. (Nasdaq:CGIX) (“CGI” or “the Company”), an emerging leader in DNA-based cancer diagnostics, announced today that it will present on its next generation sequencing (NGS) panels for hematological malignancies at the Association for Molecular Pathology’s (AMP) 2014 Annual Meeting in Harbor, MD. Principal clinical scientist Charles Ma, Ph.D., will present “Developing NGS-based Clinical Assays for Hematological Neoplasms at CGI” on Wednesday, November 12 at 3 p.m. EST. The talk, which is sponsored by Illumina, will cover the development and clinical utility of the company’s NGS panels for hematologic malignancies, specifically for CLL (chronic lymphocytic leukemia) and Myeloid disorders.

Cancer Genetics currently has several targeted, disease-specific NGS panels under development, and expects to launch its Focus::TM NGS line for clinical use by the end of 2014. The company’s NGS panels for hematological malignancies will include Focus::CLLTM for chronic lymphocytic leukemia and Focus::MyeloidTM, which will have application for several myeloid diseases including myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPN), and acute myeloid leukemia (AML). It is estimated that in the US, nearly 100,000 individuals are currently living with MDS, and another 120,000 are living with CLL.

Tumor heterogeneity and test sensitivity remain major challenges in cancer diagnostics, and are particularly problematic in hematological cancers. NGS allows for higher sensitivity and throughput than other diagnostic technologies, and can assess a greater number of mutations and other genomic aberrations at greater resolution. As a result, NGS provides simultaneous detection of mutations in a number of critical genes with a single test. When used in conjunction with other validated clinical tests, these panels provide tremendous value for diagnostic and prognostic purposes.

“We believe that our NGS panel development reinforces our position as a leader in providing high-standard diagnostic testing for hematological malignancies,” said Lan Wang, M.D., Medical Director at Cancer Genetics. “Because we can offer a variety of complementary testing services including cytogenetics, FISH, microarray, PCR/sequencing, flow cytometry, and immunohistochemistry in addition to NGS through our labs at CGI, we’ll be able to provide patients and doctors with comprehensive evaluation for these cancers, and clinically actionable diagnostic and prognostic information.”

Due to the improvement in sensitivity and throughput over other diagnostic tools, NGS is experiencing increasing demand within clinical diagnostics. In order to successfully translate NGS into the clinical setting, CGI has developed an efficient workflow based on Illumina technology that ensures high standards of accuracy, specificity, and sensitivity, while simultaneously meeting the rigorous needs for regulatory requirements, cost-efficiency, and rapid turnaround times.

The company will integrate Focus::TM NGS testing into its CompleteSM testing programs, which are currently available for a number of hematological and solid tumor cancers. CGI’s CompleteSM programs provide a suite of proprietary and conventional testing across multiple methodologies, and offer the most comprehensive diagnostic and prognostic information available.

Representatives from the company will be exhibiting at the conference at booth #1129.

About Cancer Genetics, Inc.

Cancer Genetics Inc. is an emerging leader in DNA-based cancer diagnostics, servicing some of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict treatment outcomes. These cancers include hematological, urogenital and HPV-associated cancers. We also offer a comprehensive range of non-proprietary oncology-focused tests and laboratory services that provide critical genomic information to healthcare professionals, as well as biopharma and biotech companies. Our state-of-the-art reference labs are focused entirely on maintaining clinical excellence and are both CLIA certified and CAP accredited and have licensure from several states including New York State.We have established strong research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute.

For more information, please visit or follow us:

Forward Looking Statements: This press release 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 the transaction will not close or, if it closes, will not realize 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.

Contacts

Investor Relations
Andrew McDonald Ph.D.
Life Science Advisors LLC
646-597-6987                                                  

Media Relations
Paul Kuntz
RedChip Companies, Inc.
800-733-2447, ext. 105
paul@redchip.com

 Source: Cancer Genetics, Inc.

  • Company receives second patent (US Patent No. 8,883,414) for FHACT®
  • FHACT® has potential to improve cervical cancer detection for up to 2 million women in the US each year.

RUTHERFORD, N.J., November 11, 2014 – Cancer Genetics Inc, an emerging leader in DNA-based cancer diagnostics, announced today that it has received a second US patent covering its proprietary FISH-based HPV-Associated Cancer Test (FHACT®) for cervical cancer detection in patients.

FHACT® is designed to assess change across four biomarkers indicating HPV-associated pre-cancers and cancers. Critically, FHACT® can help prevent unnecessary colposcopies and cervical biopsies, reducing costs and complications associated with these invasive procedures.

“We are pleased to have received a second patent covering our proprietary FHACT® test. Having two patents for FHACT® further strengthens our position in this important and underserved category, and highlights the test’s unique ability to revolutionize cervical cancer detection,” said Panna Sharma, CEO of Cancer Genetics Inc.

On October 21, the United States Patent and Trademark Office (USPTO) granted CGI a product design patent for the test’s unique 4-probe combination. The additional patent granted today, November 11, covers the test’s use on clinical patient samples, including cervical tissue specimen, remnant Pap-smear fluid, or liquid based cytology. The company believes that receiving patent protection for both the FHACT® test design and for its clinical application on patient samples underscores the novelty of the test, and sets a new standard in the field of cervical cancer diagnostics.

FHACT was recently reviewed in Informa Healthcare’s Expert Reviews by Dr. Jane Houldsworth.  The review can be found in volume 14, number 8 of Expert Reviews, and is accessible online at informahealthcare.com.

To learn more about FHACT®, please visit http://www.cgifhact.com.

About Cancer Genetics, Inc.

Cancer Genetics Inc. is an emerging leader in DNA-based cancer diagnostics, servicing some of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict treatment outcomes. These cancers include hematological, urogenital and HPV-associated cancers. We also offer a comprehensive range of non-proprietary oncology-focused tests and laboratory services that provide critical genomic information to healthcare professionals, as well as biopharma and biotech companies. Our state-of-the-art reference labs are focused entirely on maintaining clinical excellence and are both CLIA certified and CAP accredited and have licensure from several states including New York State.

We have established strong research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute.

For more information, please visit or follow us:

Forward Looking Statements: This press release 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 the transaction will not close or, if it closes, will not realize 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.

Contacts

Investor Relations
Andrew McDonald Ph.D.
Life Science Advisors LLC
646-597-6987

Media Relations
Paul Kuntz
RedChip Companies, Inc.
800-733-2447, ext. 105
paul@redchip.com

Source: Cancer Genetics, Inc. 

RUTHERFORD, N.J., November 10, 2014 (GLOBE NEWSWIRE) – Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics, announced today financial and operating results for the third quarter ended September 30, 2014.

  • Third quarter revenue of $3.22 million – overall revenue growth of ~90% over the same quarter of 2013, including 159% revenue growth in Biopharma Services and 44% revenue growth in Clinical Services.
  • Revenue grew 110% sequentially over the second quarter of 2014.
  • Signed contracts with biopharma customers increased 33% to over $24 million with significant increases from additional trials in hematological cancers.
  • Closed acquisitions of BioServe Biotechnologies in Hyderabad, India and Gentris in Raleigh, North Carolina during the third quarter; demonstrating rapid progress on integration and capturing sales synergies.
  • The company closed the quarter with cash and cash equivalents of $37.0 million with $30.7 million in unrestricted cash.
  • Achieved major commercial milestones for the DNA-based cervical cancer test FHACT® including: patent issuance by the US Patent Office, obtaining the CE mark to sell FHACT® as an In-Vitro-Diagnostic for HPV-associated cervical cancer in the European Union.
  • Advanced the validation and clinical utility of the proprietary genomic panel for diffuse large B-cell lymphoma (DLBCL) through collaborations with Beth Israel Deaconess Medical Center and Keck School of Medicine at USC on over 280 patients.
  • Multiple presentations and papers were accepted for the 56th Annual American Society of Hematology (ASH) Meeting in December on genomic panels for DLBCL and Multiple Myeloma.
  • Conference call today, Monday, November 10th at 8:30am Eastern / 5:30am Pacific.

“The company has significantly advanced its footprint in providing state-of-the-art genomic testing for cancer by continuing to execute growth in the clinical market and expanding our capabilities through the acquisitions of Gentris and BioServe Biotechnologies India. We have been focused on integrating our new sites in North Carolina and Hyderabad, India this past quarter so that we can immediately capture customer synergies and expand our service offering,” said Panna Sharma, President and CEO of Cancer Genetics. “As our business impacts more patients, informs the outcomes of more trials, and aids in new discoveries in oncology, we are quickly becoming the partner to help personalize the treatment of cancer from bench to bedside.”

Cancer Genetics reported total revenue of $3.22 million in the third quarter of 2014, compared to $1.71 million in the same quarter last year, and $1.51 million in the second quarter of 2014. Revenue growth was driven by strong growth in clinical testing volumes and the close of two acquisitions during the third quarter.

Year over year revenue from Biopharma Services, which provide testing for biotech and pharmaceutical customers, grew 159%. Growth in this area was due in part to new business garnered from the company’s acquisitions and from the commencement of clinical trials which had previously been delayed. The acquisitions broaden the company’s access to additional global pharmaceutical and biotech companies.

Revenue from the company’s Clinical Services, which provide oncology testing for clinicians, cancer centers, and hospitals, grew 44%. The growth in Clinical Services was driven by a 44% increase in the test count, including the number of proprietary panels for B-cell cancers being ordered.  Average reimbursement per test also improved by 4% to $484 year over year, and 8% over the prior quarter of 2014.

“This past quarter places our company in an ideal position to continue our growth from the revenue synergies derived from the acquisitions, the launch of additional tests and services, and the investments we have made in sales and marketing,” added Sharma.  “We are seeing extraordinary interest among community oncologists and pathologists for targeted genomic information that has been validated with leading research institutions to improve diagnosis, as well as guide and monitor patient treatment. The pace at which new combination protocols and new molecular therapeutics are being adopted is driving improved and more informed cancer care.  CGI is uniquely positioned as a partner in this era of precision medicine.”

“Our work with biotech and pharmaceutical partners continues to grow significantly as evidenced by the growth in our new contracts, bringing our signed contracts to over $24 million. This demand is largely driven by our offering in hematological cancers and our ability to serve clients across multiple geographies,” continued Mr. Sharma. “This unique ability to deliver clinically relevant genomic content and biomarker data in the US, India, and China is something that no other oncology-focused genomic company can match.  As the need for improved genomic profiling, patient stratification, and therapeutic response monitoring during oncology-focused clinical trials continues to grow, our value proposition grows for biotech and pharmaceutical companies.”

Financial Highlights

Third Quarter Ended September 30, 2014 – Year to Year Comparison

  • Revenues increased ~90% to $3.2 million
  • Clinical services revenue increased 44%
  • BioPharma revenue grew 159%
  • Operating expenses were $5.6 million compared to $2.2 million in 2013
  • Operating expenses during this period include $1 million in non-cash, stock based compensationand one-time expenses related to our M&A activity
  • Net loss in the third quarter was $4.8 million, or ($0.51) per diluted share
  • Adjusted net loss was $3.8 million, or ($0.41) per diluted share
  • Adjusted net loss, which is a non-GAAP measure, excludes the effect of non-cash employee stock based compensation and one-time expenses related to our M&A activity

Nine Month Period Ended September 30, 2014 vs. 2013 – Year to Year Comparison

  • Revenues increased 30% to $6.2 million
  • BioPharma revenue grew $900 thousand
  • Clinical services test volume increased 30% to 6,740
  • Operating expenses were $14.1 million, compared with $6.9 million in 2013
  • Operating expenses during this period include $2.3 million in non-cash, stock based compensation and one-time expenses related to our M&A activity
  • Net loss for the nine-month period ending September 30, 2014 was $11.5 million or ($1.25) per diluted share
  • Adjusted net loss was $9.1 million, or ($1.01) per diluted share
  • Adjusted net loss, which is a non-GAAP measure, excludes the effect of non-cash employee stock based compensation and one-time expenses related to our M&A activity
  • Cash and cash equivalents totaled $37 million with $30.7 million unrestricted at September 30, 2014

Conference Call & Webcast Details

Monday, November 10, 2014 at 8:30 a.m. EST/5:30 a.m. PST

Domestic:                                877-407-4018
International:                           201-689-8471
Conference ID:                       13594358
Webcast:                                 ir.cancergenetics.com

Replays – Available through November 24, 2014

Domestic:                                877-870-5176
International:                           858-384-5517
Conference ID:                       13594358

Reconciliation of Non-GAAP financial measures to GAAP

Cancer Genetics reports net loss without stock based compensation and expenses related to M&A activity, which is a non-GAAP measure.  The reconciliation to GAAP is as follows:

  • Non-GAAP net loss for the third quarter of 2014 excludes the effect of stock based compensation and expenses related to our M&A activity of $1 million in 2014 and $117,000 in 2013.  This results in a Non-GAAP loss of $3.8 million, or ($0.41) per diluted share in the third quarter of 2014, compared with a non-GAAP net loss of $2.9 million, or ($0.58) per diluted share, for the third quarter of 2013.  The comparable GAAP numbers are a net loss in the third quarter of $4.8 million, or ($.51) per diluted share compared to a loss of $3.1 million or ($0.61) per diluted share in the third quarter of 2013.
  • Non-GAAP net loss for the nine-month period excludes the effect of employee stock based compensation and expenses related to our M&A activity of $2.3 million in 2014 and $407,000 in 2013.  This results in a Non-GAAP loss of $9.1 million, or ($1.01) per diluted share, compared with a non-GAAP net loss of $9.4 million, or ($3.90) per diluted share, for the nine-month period ending September 30, 2013.  The comparable GAAP numbers are a net loss for the nine-month period ending September 30, 2014 of $11.5 million or ($1.25) per diluted share, compared with a loss of $9.9 million or ($4.02) per diluted share in the comparable period in 2013.

About Cancer Genetics, Inc.

Cancer Genetics Inc. is an emerging leader in DNA-based cancer diagnostics, servicing some of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict treatment outcomes. These cancers include hematological, urogenital and HPV-associated cancers. We also offer a comprehensive range of non-proprietary oncology-focused tests and laboratory services that provide critical genomic information to healthcare professionals, as well as biopharma and biotech companies. Our state-of-the-art reference labs are focused entirely on maintaining clinical excellence and are both CLIA certified and CAP accredited and have licensure from several states including New York State.

We have established strong research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute.

For more information, please visit or follow us:

Forward Looking Statements: This press release 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 the transaction will not close or, if it closes, will not realize 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.

Contacts

Investor Relations                                           Media Relations
Andrew McDonald Ph.D.                                Paul Kuntz
Life Science Advisors LLC                              RedChip Companies, Inc.
646-597-6987                                                  800-733-2447, ext. 105
paul@redchip.com

 

Cancer Genetics, Inc. and Subsidiaries
Consolidated Balance Sheets (Unaudited)

September 30,
2014
December 31,
2013
ASSETS
CURRENT ASSETS
 

Cash and cash equivalents

 $30,748,275  $49,459,564
 

Accounts receivable, net of allowance for doubtful accounts of $36,000

 4,108,567  1,567,039
 

Other current assets

 1,161,532  864,616
 

Total current assets

 36,018,374  51,891,219
 

 

FIXED ASSETS, net of accumulated depreciation

 4,338,146  1,264,624
 

OTHER ASSETS

 

Security deposits

 1,564  1,564
 

Restricted cash

 6,300,000  300,000
 

Loan guarantee and financing fees, net of accumulated amortization of $517,500 in 2013

 —  310,500
 

Patents

 476,971  401,709
 

Investment in joint venture

 1,328,231  987,657
 

Other investments

 39,393  —
 

Goodwill

 3,130,574  —
 

Total other assets

 11,276,733  2,001,430
 

Total Assets

 $51,633,253  $55,157,273
 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

CURRENT LIABILITIES

 

Accounts payable and accrued expenses

 $4,564,065  $2,346,240
 

Obligations under capital leases, current portion

 57,606  51,400
 

Deferred revenue

 384,354  199,560
 

Notes payable, current portion

 280,854  22,298
 

Line of credit

 —  6,000,000
 

Total current liabilities

 5,286,879  8,619,498
 

Obligations under capital leases

 322,939  309,777
 

Deferred rent payable

 152,739  170,789
 

Line of credit

 6,000,000  —
 

Warrant liability

 145,000  594,000
 

Other long-term liabilities

 767,663  —
 

Deferred revenue, long-term

 936,496  —
 

Total liabilities

 13,611,716  9,694,064
 

STOCKHOLDERS’ EQUITY

  Preferred stock, authorized 9,764,000 shares, $0.0001 par value, none issued  —  —
  Common stock, authorized 100,000,000 shares, $0.0001 par value, 9,723,669 and 9,275,384 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively  970  927
 

Additional paid-in capital

 110,814,811  106,786,862
 

Accumulated deficit

 (72,794,244)  (61,324,580)
 

Total Stockholders’ Equity

 38,021,537  45,463,209
 

 

Total Liabilities and Stockholders’ Equity

                                  $51,633,253  $55,157,273

 

Cancer Genetics, Inc. and Subsidiaries
Consolidated Statements of Operations (Unaudited)

 

  Three Months Ended September 30, Nine Months Ended September 30,
  2014 2013 2014 2013
 

Revenue

 $3,221,850  $1,705,146  $6,163,895  $4,755,462
 

Cost of revenues

 2,565,715  1,211,384  5,358,872  3,560,678
 

Gross margin

 656,135  493,762  805,023  1,194,784
 

Operating expenses:

 

Research and development

 1,390,189  433,525  3,092,733  1,384,122
 

General and administrative

 3,104,100  1,297,801  8,230,966  4,259,175
 

Sales and marketing

 1,070,531  442,665  2,737,967  1,274,620
 

Total operating expenses

 5,564,820  2,173,991  14,061,666  6,917,917
 

Loss from operations

 (4,908,685)  (1,680,229)  (13,256,643)  (5,723,133)
 

Other income (expense):

 

Interest expense

 (36,166)  (356,442)  (408,087)  (2,039,750)
 

Interest income

 18,789  3,295  57,130  4,649
 

Debt conversion costs

 —  —  —  (6,849,830)
 

Change in fair value of warrant liability

 129,000  (1,033,000)  324,000  4,096,000
 

Total other income (expense)

 111,623  (1,386,147)  (26,957)  (4,788,931)
 

Income (loss) before income taxes

 (4,797,062)  (3,066,376)  (13,283,600)  (10,512,064)
 

Income tax provision (benefit)

 —  —  (1,813,941)  (663,900)
 

Net income (loss)

 $(4,797,062)  $(3,066,376)  $(11,469,659)  $(9,848,164)
 

Basic net income (loss) per share

 $(0.50)  $(0.61)  $(1.22)  $(2.84)
 

Diluted net loss per share

 $(0.51)  $(0.61)  $(1.25)  $(4.02)
 

Basic Weighted Average Shares Outstanding

 9,575,789  5,055,591  9,386,613  3,463,730
 

Diluted Weighted Average Shares Outstanding

 9,575,789  5,055,591  9,403,245  3,468,627

###

Source: CancerGenetics.com

Date: November 8, 2014
Location: Phoenix, AZ

Date: October 28, 2014
Location: New York, NY


Our Services

At Gentris, we believe in providing the highest level of quality services to meet our customer’s needs. From our CAP Accredited biorepository, to our CLIA regulated laboratory, we strive to be the leader in pharmacogenomics solutions.