UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT
TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF
1934
For the month of April 2015
Commission File Number 001-33042
ROSETTA GENOMICS LTD.
(Translation of registrant’s name
into English)
| |
| 10 Plaut Street, Science Park |
| Rehovot 76706, Israel |
| (Address of Principal Executive Offices) |
Indicate by check mark whether the registrant files or will
file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F [Ö ]
Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form
6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
Rosetta Genomics Ltd.
On April 9, 2015, Rosetta Genomics Ltd. (“Rosetta”
or the “Company”) issued a press release announcing that it had agreed to acquire CynoGen, Inc. (d/b/a PersonalizeDx)
from Prelude Corporation, a Fjord Ventures portfolio company. On April 14, Rosetta issued a press release announcing that it had
closed the acquisition of CynoGen, Inc. The purchase price included $2.0 million in cash, 500,000 of Rosetta’s ordinary shares
and the provision of certain assets and services to Prelude Corporation.
A copy of each press release is filed as Exhibit 99.1 and Exhibit
99.2, respectively, to this Form 6-K and incorporated by reference herein.
The information contained in this Report (including the Exhibits
hereto) is hereby incorporated by reference into the Company’s Registration Statements on Form F-3, File Nos. 333-163063,
333-171203, 333-172655, 333-177670 and 333-185338.
Exhibits
Exhibit
| Number | Description of Exhibit |
| 99.1 | Press release dated April 9, 2015. |
| 99.2 | Press release dated April 14, 2015. |
Signatures
Pursuant to the requirements of the Securities
Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| |
|
| |
ROSETTA GENOMICS LTD. |
| |
|
Date: April 14, 2015 |
By: |
/s/ Oded Biran |
|
| |
|
Oded Biran
Chief Legal Officer and Corporate Secretary |
|
| |
Exhibit 99.1
| News Release |
 |
Rosetta Genomics
to Acquire PersonalizeDx
| · | Creates a broader commercial footprint and expanded product offering
in oncology diagnostics with numerous near-term product launches to accelerate revenue growth |
| · | Enhances Rosetta Genomics’ leadership as a provider of proprietary
and differentiated content in the personalized medicine arena |
| · | Rosetta Genomics expects annualized pro forma 2015 revenues of $10
million to $12 million, and 2016 revenues to exceed $18 million |
PRINCETON, N.J. and REHOVOT, Israel
(April 9, 2015) – Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based and
other molecular diagnostics, announces it has agreed to acquire CynoGen, Inc. (d/b/a PersonalizeDx) from Prelude Corporation, a
Fjord Ventures portfolio company. The acquisition of PersonalizeDx by Rosetta Genomics is expected to close within the next several
weeks and is contingent upon the closing of Prelude’s purchase of PersonalizeDx from a third party.
PersonalizeDx is a rapidly growing molecular
diagnostics and services company serving community-based pathologists, urologists, oncologists and other reference laboratories
across the U.S. Through this transaction Rosetta Genomics will gain proprietary tests in prostate, bladder and lung cancer, strong
commercial and laboratory operations capabilities and a state-of-the-art, high-complexity CLIA laboratory in Lake Forest, California.
The purchase price includes $2.0 million
in cash, 500,000 ordinary shares of Rosetta Genomics Ltd., some specified assets and certain services to be provided by Rosetta
Genomics to Prelude Corporation. In connection with this transaction Rosetta Genomics will gain rights to market Prelude’s
novel assay for ductal carcinoma in situ (DCIS).
“The acquisition of PersonalizeDx
will have wide-ranging, positive financial, commercial, operational and pipeline impact on Rosetta Genomics, and brings with it
exceptional talent to complement the industry-leading team at Rosetta Genomics. The PersonalizeDx business is an excellent strategic
and cultural fit, and we look forward to combining their assays and biomarkers with our current and future microRNA-based and other
assays. With the expected close of this transaction, we extend a warm welcome to our new colleagues from PersonalizeDx,”
said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.
“In joining forces with PersonalizeDx,
Rosetta Genomics will gain critically important commercial and revenue scale in the marketplace for oncology diagnostics, along
with a strategic focus on delivering high-value content that aids in diagnoses, optimizes treatment decisions, enables targeted
therapy selections and facilitates treatment monitoring. A shared commitment to unsurpassed quality and turnaround time and to
improving the lives of people with cancer will guide our operations and contribute to our success,” added Mr. Berlin.
According to Olav Bergheim, Managing Director
of Fjord Ventures, “Rosetta Genomics, with its commitment to being a leading provider of differentiated and proprietary content
in the area of personalized medicine, is a great strategic fit for PersonalizeDx. In addition to world-leading expertise in microRNA-based
assay development, Rosetta Genomics brings strong reimbursement capabilities and service lab operational know-how.”
Financials and Financial Guidance
On an annualized pro forma basis, including
the operations of the PersonalizeDx business, Rosetta Genomics expects 2015 revenues to be in the range of $10 million to $12 million,
and expects 2016 revenues to exceed $18 million. Rosetta Genomics also expects to achieve positive EBITDA and positive cash flow
from operations prior to the end of 2017.
Product and Commercial Synergies
Rosetta Genomics currently offers the Rosetta
Cancer Origin Test™, the Rosetta Lung Cancer Test™ and the Rosetta Kidney Cancer Test™,
and plans to launch its thyroid neoplasia assay in the third quarter of 2015. Rosetta Genomics markets the Rosetta Genomics PGxOne™
test and the EGFR and KRAS sequencing services for Admera Health.
The expected expanded commercial capability
from combining these two companies will benefit the launch of Rosetta Genomics’ novel thyroid assay later this year, as well
as the launches of new PersonalizeDx products.
There are multiple areas of product synergies
between Rosetta Genomics and the PersonalizeDx business, notably in urologic and lung cancers. For example, the recent combination
of Rosetta’s Lung Cancer Test with Admera’s genomic markers for targeted therapies will be strengthened by adding the
PersonalizeDx Fluorescence in situ Hybridization (FISH) and molecular markers for actionable genomic targets, thereby creating
a strong lung cancer diagnostic franchise.
Including the pipeline from PersonalizeDx,
Rosetta Genomics is now positioned to launch five novel, proprietary assays within the next 12 months, which will provide a foundation
for growth well into the future.
About Rosetta Cancer Testing Services
Rosetta Cancer Tests are a series of microRNA-based
diagnostic testing services offered by Rosetta Genomics. The Rosetta Cancer Origin Test™ can accurately identify
the primary tumor type in primary and metastatic cancer including cancer of unknown or uncertain primary (CUP). The Rosetta Lung
Cancer Test™ accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. The
Rosetta Kidney Cancer Test™ accurately classifies the four most common kidney tumors: clear cell renal cell carcinoma
(RCC), papillary RCC, chromophobe RCC and oncocytoma. Rosetta’s assays are designed to provide objective diagnostic data;
it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta
Genomics estimates that 200,000 patients a year may benefit from the Rosetta Cancer Origin Test™, 65,000 from
the Rosetta Kidney Cancer Test™ and 226,000 patients from the Rosetta Lung Cancer Test™. The Company’s
assays are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. In addition, Rosetta markets
the Rosetta Genomics PGxOne™ test and the EGFR and KRAS sequencing services for Admera Health. For more information,
please visit www.rosettagenomics.com. Parties interested in ordering any of these tests should contact Rosetta Genomics at (215)
382-9000 ext. 309.
About Rosetta Genomics
Rosetta develops and commercializes a full
range of microRNA-based molecular diagnostics. Founded in 2000, Rosetta’s integrative research platform combining bioinformatics
and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs.
Building on its strong patent position and proprietary platform technologies, Rosetta is working on the application of these technologies
in the development and commercialization of a full range of microRNA-based diagnostic tools. Rosetta’s cancer testing services
are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab.
About Prelude Corporation
Prelude Corporation is developing a prognostic
test for ductal carcinoma in situ (DCIS). The company’s proprietary risk algorithms combine results from a panel of
biomarkers that reveal a patient’s DCIS biology. Over 60,000 women in the United States are diagnosed with DCIS (stage 0
breast cancer) annually. Prelude’s DCIS test is designed to enable these women and their treating physicians to make personalized
treatment decisions based on their own biological profile. This approach may help thousands of women avoid overly aggressive therapies
that contribute to the rising cost of healthcare and increasing morbidity.
About Fjord Ventures
Fjord Ventures, founded by life science
entrepreneur Olav Bergheim, is an innovative technology accelerator that creates and invests in companies developing disruptive
healthcare solutions. Fjord provides portfolio companies with operational management expertise and a highly capital efficient shared
infrastructure. Fjord focuses on identifying, developing and commercializing life science innovations. Since its formation in 2005,
Fjord Ventures has created more than 10 companies.
Forward-Looking Statement Disclaimer
Various statements in this news release
concerning Rosetta’s future expectations, plans and prospects, including without limitation, the expectation for pro forma
revenues in 2015 and 2016, and that Rosetta expects to achieve positive EBITDA and positive cash flow from operations in 2017,
statements relating to any synergies, including product synergies, or other expectations regarding the acquisition of PersonalizeDx,
including that the acquisition will have wide-ranging and positive financial, commercial, operational and pipeline impact, and
the timing with respect to commercial launch of assays within the next 12 months as well any information relating to the expected
closing of the acquisition, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private
Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements
as a result of various important factors, including those risks more fully discussed in the "Risk Factors" section of
Rosetta’s Annual Report on Form 20-F for the year ended December 31, 2014 as filed with the SEC. In addition, any forward-looking
statements represent Rosetta’s views only as of the date of this news release and should not be relied upon as representing
its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required
by law.
Company Contact:
Rosetta Genomics
Ken Berlin, President & CEO
(609) 419-9003
investors@rosettagenomics.com
Investor Contacts:
LHA
Anne Marie Fields
(212) 838-3777
afields@lhai.com
or
Bruce Voss
(310) 691-7100
bvoss@lhai.com
# # #
Exhibit 99.2
| News Release |
|
Rosetta Genomics Completes Acquisition
of PersonalizeDx
PRINCETON, N.J. and REHOVOT, Israel
(April 14, 2015) – Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based and
other molecular diagnostics, announces the closing of its acquisition of CynoGen, Inc. (d/b/a PersonalizeDx) from Prelude Corporation.
“We are delighted to complete this
important, strategic acquisition and look forward to integrating PersonalizeDx into Rosetta Genomics,” said Kenneth A. Berlin,
President and Chief Executive Officer of Rosetta Genomics. “There are multiple areas of product synergies between these two
businesses, notably in urologic and lung cancers. Furthermore, including the PersonalizeDx pipeline, Rosetta Genomics is poised
to launch five novel, differentiated assays within the next 12 months. This acquisition and the near term product launches will
provide a foundation for growth well into the future and will expand our leadership position in bringing to market differentiated
content in the area of personalized medicine.”
PersonalizeDx is a rapidly growing molecular
diagnostics and services company serving community-based pathologists, urologists, oncologists and other reference laboratories
across the U.S. PersonalizeDx recorded revenues for 2014 of $6.9 million (unaudited), a nearly three-fold increase compared with
2013 (unaudited). Through this transaction Rosetta Genomics gains proprietary tests in prostate, bladder and lung cancer, strong
commercial and laboratory operations capabilities and a state-of-the-art, high-complexity CLIA laboratory in Lake Forest, California.
“The complementary molecular test
offerings of PersonalizeDx and Rosetta Genomics will allow us to provide urologists with a broad range of unique solutions for
the various tumor types they treat, and assist with difficult clinical decisions for their prostate, bladder and kidney cancer
patients,” said Chris Emery, General Manager of PersonalizeDx. “We are also excited for the combined companies to maximize
the commercial potential of the current PersonalizeDx offerings and pipeline opportunities in lung and breast cancer,” he
added.
PersonalizeDx is focused on the detection
of genomic changes through FISH technology, which helps to detect cancer, measure the potential aggressiveness of the disease and
identify patients most likely to respond to targeted therapies. The company offers a “FISH Local” technical-only service
option for all of its FISH-based tests, which allows pathologists to deliver expert case results to oncologists and urologists
through reports that are customizable to the local pathology brand. The FISH service offered by PersonalizeDx is best-in-class
with a highly competitive success rate in obtaining informative FISH results of 98% and excellent turnaround time of three to four
days.
PersonalizeDx has the following additional
novel content, which enables clinicians to practice personalized medicine:
| · | ERG is a proprietary prognostic test for
patients with prostate cancer that provides urologists with results of favorable versus poor prognosis to help inform the decision
to proceed with surgery or active surveillance. This product is available as a global or technical-only FISH service and is offered
in combination with PTEN for a comprehensive overall prognostic assessment. ERG was launched in 2014 and the annual U.S. market
for ERG/PTEN testing is approximately $100 million. |
| · | FGFR3 mutation analysis identifies low-grade
bladder cancer from urine and tissue-based specimens. Test results help urologists to monitor patients, and also assist with prognosis
and tumor grading. When used in conjunction with the company’s leading FISH testing, the combined offering will provide a
highly sensitive and specific diagnostic test for all stages of bladder cancer. FGFR3 addresses an annual U.S. market opportunity
of approximately $250 million and is expected to launch prior to the end of 2015. |
In addition to these differentiated products,
in connection with this transaction Rosetta Genomics gains certain rights to market Prelude’s novel assay for ductal carcinoma
in situ (DCIS). Prelude DCIS is a novel, proprietary prognostic test for breast cancer with the goal of decreasing radiation
overtreatment in patients with DCIS (stage 0 breast cancer). This product differentiates DCIS patients at high risk versus low
risk for recurrence, as well as DCIS patients who are likely to respond to therapy versus those who are not likely to respond.
Prelude DCIS addresses an approximate $200 million annual U.S. market opportunity. Rosetta Genomics expects to market Prelude DCIS
as a laboratory developed test within the next six months.
About Rosetta Cancer Testing Services
Rosetta Cancer Tests are a series of microRNA-based
diagnostic testing services offered by Rosetta Genomics. The Rosetta Cancer Origin Test™ can accurately identify
the primary tumor type in primary and metastatic cancer including cancer of unknown or uncertain primary (CUP). The Rosetta Lung
Cancer Test™ accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. The
Rosetta Kidney Cancer Test™ accurately classifies the four most common kidney tumors: clear cell renal cell carcinoma
(RCC), papillary RCC, chromophobe RCC and oncocytoma. Rosetta’s assays are designed to provide objective diagnostic data;
it is the treating physician’s responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta
Genomics estimates that 200,000 patients a year may benefit from the Rosetta Cancer Origin Test™, 65,000 from
the Rosetta Kidney Cancer Test™ and 226,000 patients from the Rosetta Lung Cancer Test™. The Company’s
assays are offered directly by Rosetta Genomics in the U.S., and through distributors around the world. In addition, Rosetta markets
the Rosetta Genomics PGxOne™ test and the EGFR and KRAS sequencing services for Admera Health. For more information,
please visit www.rosettagenomics.com. Parties interested in ordering any of these tests should contact Rosetta Genomics at (215)
382-9000 ext. 309.
About Rosetta Genomics
Rosetta develops and commercializes a full
range of microRNA-based molecular diagnostics. Founded in 2000, Rosetta’s integrative research platform combining bioinformatics
and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs.
Building on its strong patent position and proprietary platform technologies, Rosetta is working on the application of these technologies
in the development and commercialization of a full range of microRNA-based diagnostic tools. Rosetta’s cancer testing services
are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab.
Forward-Looking Statement Disclaimer
Various statements in this news release
concerning Rosetta’s future expectations, plans and prospects, including without limitation, that Rosetta will launch five
assays within the next 12 months, that the acquisition of PersonalizeDx and the near term product launches will provide a foundation
for growth well into the future and will expand Rosetta’s leadership position , the timing of commercial launch of the FGFR3
test and the Prelude DCIS test, the potential market opportunities for certain tests and services, and that the combined companies
will maximize the commercial potential of the current PersonalizeDx offerings and pipeline opportunities, constitute forward-looking
statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by these forward-looking statements as a result of various important factors, including
those risks more fully discussed in the "Risk Factors" section of Rosetta’s Annual Report on Form 20-F for the
year ended December 31, 2014 as filed with the SEC. In addition, any forward-looking statements represent Rosetta’s
views only as of the date of this news release and should not be relied upon as representing its views as of any subsequent date.
Rosetta does not assume any obligation to update any forward-looking statements unless required by law.
Company Contact:
Rosetta Genomics
Ken Berlin, President & CEO
(609) 419-9003
investors@rosettagenomics.com
Investor Contacts:
LHA
Anne Marie Fields
(212) 838-3777
afields@lhai.com
or
Bruce Voss
(310) 691-7100
bvoss@lhai.com
# # #
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