UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): January 16, 2019
CANCER GENETICS, INC.
(Exact Name of Registrant as Specified in its Charter)
| Delaware | 001-35817 | 04-3462475 | ||
| (State or Other Jurisdiction | (Commission | (IRS Employer | ||
| of Incorporation) | File Number) | Identification No.) |
201 Route 17 North 2nd Floor, Rutherford, New Jersey 07070
(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including area code (201) 528-9200
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined by Rule 405 of the Securities Act of 1933 (17 §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company [X]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [X]
Item 2.02. Results of Operations and Financial Condition.
On January 16, 2019, Cancer Genetics, Inc. (the “Registrant”) announced the publication of a letter from John A. Roberts, President and Chief Executive Officer, to the Company’s stockholders containing business updates. A copy of the announcement is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
Item 7.01 Regulation FD Disclosure.
See “Item 2.02 Results of Operations and Financial Condition” above.
The information in this Current Report on Form 8-K under Items 2.02 and 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as shall be expressly set forth by a specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release issued by Cancer Genetics, Inc. dated January 16, 2019. |
| 2 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CANCER GENETICS, INC. | ||
| By: | /s/ John A. Roberts | |
| Name: | John A. Roberts | |
| Title: | Chief Executive Officer | |
| Date: January 16, 2019 | ||
| 3 |
Cancer Genetics Issues Letter to Shareholders
RUTHERFORD, N.J., Jan. 16, 2019 -- Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for immuno-oncology and genomic medicine through molecular markers and diagnostics, today published a letter to shareholders from its Chief Executive Officer, Jay Roberts.
Dear Shareholders,
Happy New Year – we are pleased to provide an update on our activities and strategic development. We believe that 2018 was an important time for re-assessing our corporate direction, consolidating our company operations and focusing our capabilities in our biopharma business to execute our restructuring, while focusing on revenue growth and accelerating our path to profitability. We believe that the repositioning initiatives we have undertaken over the last few months will support our efforts to achieve near-term success.
We continue to work with Raymond James & Associates, Inc. to complete a strategic transaction with the goal of enhancing shareholder value. We are making positive strides in this regard, and anticipate announcing the results of our efforts in Q1 2019.
We carried out a number of steps to improve our performance and accelerate the path to profitability through the execution of our transformation plans. First, we completed the sale of our operations in India, for $1.85 million in cash. Second, the operations from our LA lab facility were consolidated successfully into New Jersey and North Carolina, on time and within budget. We incurred approximately $2.15 million in restructuring charges during the first three quarters of 2018, and as a result, we reduced our annualized costs by over $4 million and expect to see the results of these actions beginning with our 4th quarter results and beyond. We are now focusing our efforts on streamlining and optimizing lab operations in our New Jersey facility. We believe that this step will enable us to improve our overall efficiency and continue to reduce our overall operating costs. We continue to expand our efforts on our biopharma and preclinical services business. We intend to focus our efforts in our clinical services business on high performing tests that have strong demand and favorable reimbursement which we believe will increase our profitability. We expect to report quarterly sequential revenue growth and operating cost reductions for Q4 2018.
WE CONSUMMATED SEVERAL NEW AGREEMENTS
We launched Thermo Fisher Scientific’s next-generation sequencing (NGS) Oncomine™ Comprehensive Assay v3 to drive clinical trial opportunities with key channel partners. The new version of this assay delivers superior tumor profiling capabilities that can generate results to assist researchers in decision making. We entered a manufacturing and supply agreement with AGILENT for our custom probe that is used in the Company’s proprietary FISH-based HPV-Associated Cancer Test (FHACT) and expect to license the probes through domestic and international distribution channels. We also negotiated a partnership with Cellaria, a scientific innovator that develops revolutionary new cancer models. Additionally, we consummated an exclusive distribution agreement with Genecast Biotechnology to market, distribute and sell the Tissue of Origin® (TOO) Test in China. The TOO test is a microarray-based gene expression test that analyzes a tumor’s genomic information to help identify its origin, which is valuable in classifying metastatic, poorly differentiated, or undifferentiated cancers. We believe these agreements will contribute to our biopharma business and generate future revenue beginning in Q1 2019.
We also strengthened our management team with the appointment of Glenn Miles as the Chief Financial Officer and Michael McCartney as the Chief Commercial Officer. Glenn brings valuable financial and accounting leadership experience, which will help us execute on our transformation strategy and build a foundation for sustainable growth and profitability. Michael is responsible for developing and overseeing Cancer Genetics’ commercial strategy and spearheading the Company’s business development initiatives. We have successfully secured new contracts with the potential to generate approximately $32 million in biopharma revenues in the coming 2 to 3 years. We believe both Glenn and Michael will help expand our business and accelerate our path to profitability.
We are extremely grateful to you, our loyal shareholders, for your support as we execute our strategic initiatives and advance our capabilities in the precision oncology space. We will continue to keep you informed of our progress and remain optimistic about our future.
Jay Roberts
Chief Executive Officer
Cancer Genetics
ABOUT CANCER GENETICS
Cancer Genetics, Inc. is a leader in enabling precision medicine in oncology through the use of biomarkers and molecular testing. CGI is developing a global footprint with locations in the US and Australia. We have established strong clinical research collaborations with major cancer centers such as Memorial Sloan Kettering, The Cleveland Clinic, Mayo Clinic, Keck School of Medicine at USC and the National Cancer Institute.
The Company offers a comprehensive range of laboratory services that provide critical genomic and biomarker information. Its state-of-the-art reference labs are CLIA-certified and CAP-accredited in the US and have licensure from several states including New York State.
For more information, please visit or follow CGI at:
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 Cancer Genetics, Inc.’s expectations regarding future financial and/or operating results, potential for our tests and services and future revenues or growth in this press release 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 with respect to our ability to complete a strategic transaction, risks with respect to our need and ability to obtain future capital to satisfy our obligations to our lenders and creditors, risks inherent in the development and/or commercialization of potential tests, risks of cancellation of customer contracts or discontinuance of trials, risks that anticipated benefits from consolidation efforts and/or acquisitions will not be realized, uncertainty in the results of clinical trials or regulatory approvals, uncertainties with respect to evaluating strategic options, maintenance of intellectual property rights, risks with respect to maintaining our listing on Nasdaq, and other risks discussed in the Cancer Genetics, Inc. Form 10-K for the year ended December 31, 2017 and Form 10-Q for the quarter ended September 30, 2018, along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics, Inc. disclaims any obligation to update these forward-looking statements.
Investor Contact:
Lee Roth
The Ruth Group
Tel: 646-536-7012
Email: lroth@theruthgroup.com