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 January 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 þ
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 January 12, 2015, Rosetta Genomics Ltd. (“Rosetta”
or the “Company”) issued a press release announcing that a Letter to Shareholders from Rosetta’s President and
Chief Executive Officer Kenneth A. Berlin had been posted to the Investors section of the Company’s website. The text of
the letter was included in the press release. A copy of the press release is filed as Exhibit 99.1 to this Form 6-K and incorporated
by reference herein.
The information contained in this Report 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 |
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Number |
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Description of Exhibit |
99.1 |
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Press release dated January 12, 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.
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ROSETTA GENOMICS LTD. |
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Date: January 12, 2015 |
By: |
/s/ Oded Biran |
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Oded Biran
Chief Legal Officer and Corporate Secretary |
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Exhibit 99.1
News Release
Rosetta
Genomics Issues Letter to Shareholders
PRINCETON, N.J. and REHOVOT, Israel
(January 12, 2015) – Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based
molecular diagnostics, announces the posting of the following Letter to Shareholders from President and Chief Executive Officer
Kenneth A. Berlin to the Investors section of the Company’s website at www.rosettagenomics.com.
Dear Fellow Shareholders:
As we begin the New Year, I would like
to express my appreciation to all our shareholders for the trust and support you have given Rosetta Genomics as we continue to
build upon our microRNA platform technology to strengthen our leading position in the growing field of molecular diagnostics and
genomics.
Throughout 2014 we made significant progress
advancing our three key areas for growth: current product sales, new product development and third-party collaborations.
We are particularly pleased with the progress
we have made in growing current product sales. Last year we strengthened our commercial leadership team with the addition
of key hires to drive demand and secure reimbursement, with considerable success in both areas. We expect revenue for the second
half of 2014 to be approximately 40% higher compared with the first half of 2014, and to be more than three times
the revenue we recorded in the second half of 2013. While we are still in the early stages of our full commercialization efforts
and these increases are off a modest base, the growth and trends demonstrate that our strategy and marketing programs are bearing
fruit as we continue to progress our microRNA-based solutions for oncology.
In addition to our current commercial products,
we expanded our product portfolio with the recent collaboration with Admera Health for the commercialization of current
and future sequencing-based oncology tests. We entered 2015 with the launch of the first of these products and are now offering
PGxOne™, a pharmacogenomics test that predicts a patient’s response to drugs based on personal genetic makeup to avoid
adverse effects; and EGFR and KRAS clinical sequencing, which provides genomic analysis of those tumor-based mutations
from patient tissue to provide clinically relevant information relating to potential response to therapy, which is helpful for
physicians, pathologists and researchers. These new products are synergistic with our current suite of oncology testing services,
expand our call point to hospital-based pharmacies and should begin to contribute to our growing revenue stream in the first half
of 2015.
We continue to expand our pipeline of
novel microRNA-based solutions with the addition of new indications for diagnostic issues in the areas of thyroid and bladder
cancer, as well as the most recent addition to our pipeline, endometrial cancer.
The first of these is our product line
in the area of thyroid cancer. The first indication we are pursuing in this area is for the differential diagnosis of indeterminate
Fine Needle Aspirates (FNAs) from thyroid nodules, which can reduce unnecessary surgeries and their associated costs and complications.
We are pleased to report we are on track to launch this assay by the end of the third quarter of this year. We anticipate that
this assay will be competitive with current alternatives. We believe our specimen collection process will be a competitive differentiator,
as it is expected to utilize the actual smear used by the cytologist as opposed to taking additional FNAs and preserving them in
specialized tubes. That latter approach is required by some currently marketed thyroid tests, which were expected to generate sales
of $45-$50 million in 2014. Importantly, we will soon begin validation studies and are on track to launch our microRNA-based thyroid
neoplasia assay in the third quarter of 2015. We believe this will be an important product for our portfolio as earlier competitors
have already established the market, and since up to 30% of FNAs yield indeterminate results. The resulting U.S. opportunity alone
exceeds $350 million.
We continue to work to advance our bladder
cancer assay for the risk stratification of Non-muscle-invasive bladder cancer (NMIBC) patients. Risk stratification in NMIBC is
necessary to identify patients at high risk for progression to invasive bladder cancer so that life-saving interventions can be
implemented, and to classify low-risk patients in order to avoid invasive and unnecessary procedures and follow-ups. This is particularly
important, as 70%-80% of bladder cancers are considered to be of the NMIBC type. We have two foundational studies already completed
and published that demonstrate the role of microRNAs for risk stratification in bladder cancer. We plan to initiate an additional
study this year and expect to launch this new assay by the end of 2016.
We are also working to develop the newest
addition to our product portfolio, an assay for the preoperative risk stratification of endometrial cancer patients. Nearly 53,000
cases of endometrial cancer were diagnosed in 2014. Better preoperative risk assessment is needed for improved planning of the
surgical procedure and, more specifically, for identifying patients who may benefit from lymph node dissection and low risk patients
for whom lymphadenectomy could be omitted, thereby averting unnecessary morbidity. We will undertake proof-of-concept studies in
2015 and expect to advance this potentially high-value diagnostic assay thereafter.
In 2014, we were particularly successful
in securing and advancing third-party collaborations as we build on efforts to further monetize our leading microRNA biomarker
platforms. We opened 2014 with the announcement of a master service provider agreement with an undisclosed major global biopharmaceutical
company. Here, we are using our cutting-edge microRNA expertise and capabilities to assist one of the world’s leading biopharmaceutical
companies to advance their research and development efforts in an important, novel therapeutic approach in an area of unmet medical
need. We have completed the feasibility phase of this agreement and moved to the next stage of this collaboration, which recently
began to generate revenues.
In April 2014 we established a strategic
alliance with Marina Biotech, a leading nucleic acid-based drug discovery and development company focused on rare diseases, to
jointly identify and develop microRNA-based products designed to diagnose and treat various neuromuscular diseases and dystrophies.
We recently reported initiation of the first of these projects, which is a clinical study conducted by Rosetta Genomics to identify
novel microRNA candidates for the treatment of Duchenne Muscular Dystrophy. We are very excited about the potential of this project
to identify specific microRNA signatures to identify therapeutic candidates for Marina Biotech to develop as potential new treatment
options for this disease, which typically afflicts young boys.
Finally, we entered into a three-year alliance
with Moffitt Cancer Center, a National Cancer Institute-designated Comprehensive Cancer Center, to discover, develop and commercialize
a variety of microRNA-based cancer diagnostics and to stimulate new projects and collaborations for the development of diagnostics
in areas of unmet medical need. Rosetta will provide funding for Moffitt investigator-initiated projects that align with Rosetta’s
strategic priorities.
We continue to pursue additional strategic
partnerships that will allow us to leverage our cutting-edge microRNA platforms and capabilities, and expect that over time these
will be significant drivers of value. In addition, we continue to evaluate the acquisition or licensure of other diagnostic and
sequencing products in order to leverage the investments we are making in our commercial infrastructure and to accelerate revenue
growth. The collaboration with Admera is one such example.
We remain vigilant in continuing to build
and strengthen our intellectual property, and are pleased to have added three U.S. patents to our growing portfolio during 2014.
As a result we now have 39 issued patents, including 35 in the U.S. In addition we have 49 patent applications pending, of
which 28 are in the U.S. These issued patents and applications protect the specific microRNAs used in our products and cover composition
of matter, diagnostic applications, therapeutic applications and discovery process applications for microRNAs in humans. This leading
patent position provides access to hundreds of potential microRNA biomarkers and offers the potential for multiple opportunities
for research, development and commercial partnerships. We remain a leading pioneer of microRNA technology and our broad and expanding
patent portfolio will continue to fortify our leadership position as the vast potential of microRNA technologies is realized.
We are very pleased with the progress we
have made and expect 2015 to be an exciting year of growth and accomplishments as we advance our strategic plan in pursuit of our
mission to be the pioneering force in microRNA-based personalized medicine to the benefit of patients worldwide.
On behalf of my colleagues and our Board
of Directors, thank you for your continued support of Rosetta Genomics.
Sincerely,
Kenneth A. Berlin
President and Chief Executive Officer
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). Rosetta Mesothelioma
Test™ diagnoses mesothelioma, a cancer connected to asbestos exposure. 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™, 60,000 from the Rosetta Mesothelioma 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. For more
information, please visit www.rosettagenomics.com. Parties interested in ordering the test can contact Rosetta Genomics
at (215) 382-9000 ext. 309.
About Rosetta Genomics
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 and therapeutics. Rosetta currently commercializes a full range of microRNA-based molecular diagnostics. Rosetta’s
cancer testing services are commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab. For
more information, please visit www.rosettagenomics.com.
Forward-Looking Statement Disclaimer
Various statements in this release concerning
Rosetta’s future expectations, plans and prospects, including without limitation, statements that Rosetta expects expect
revenue for the second half of 2014 to be approximately 40% higher compared with the first half of 2014, and to be more than three
times the revenue we recorded in the second half of 2013, that Rosetta's marketing of the PGxOne™, EGFR and KRAS tests will
contribute to its revenue stream in the first half of 2015, that Rosetta’s thyroid neoplasia assay will be launched in the
third quarter of 2015 and that such assay will be competitive with current alternatives, that Rosetta expects to launch the bladder
cancer assay by the end of 2016, that Rosetta will undertake proof-of-concept studies for the assay for the preoperative risk stratification
of endometrial cancer patients in 2015 and advance this assay thereafter, that additional strategic partnerships will be significant
drivers of value, and that 2015 will be an exciting year of growth and accomplishments, 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, 2013 as filed with the SEC. In addition, any forward-looking statements represent Rosetta’s views only as of the
date of this 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.
Rosetta Genomics Contact: |
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Ken Berlin, President & CEO |
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(609) 419-9003 |
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investors@rosettagenomics.com |
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Rosetta Genomics Investor Contacts: |
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LHA |
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Anne Marie Fields |
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(212) 838-3777 |
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afields@lhai.com |
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or |
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Bruce Voss |
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(310) 691-7100 |
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bvoss@lhai.com |
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