Rosetta Genomics A0MMDG

Rosetta Genomics        is an international leader in  diagnostic and therapeutic product development and medical research involving micro-ribonucleic acid, commonly known as microRNA.

Rosetta has developed an extensive integrated platform in microRNA research and data that brings together the most advanced findings and capabilities in genomics, bioinformatics and biotechnology.

As a result, the company is recognized by leaders in the pharmaceutical and biotechnology industries and in academia as an important resource  in the rapidly growing area of microRNA product development.  Originally believed to be components of nonfunctioning “junk DNA”, microRNAs are now known to play a critical role in essential cellular functions in the body, including protein production, cell differentiation and cell death.

Because these functions also affect disease progression, many recent research findings indicate that microRNA itself is a pivotal factor in numerous aspects of human health. By understanding and harnessing the power of microRNA, researchers see significant potential to develop new treatments and diagnostic products for many serious illnesses, including targets in cancer, infectious diseases and autoimmune disorders. Building on innovative avenues of medical research made possible by the Human Genome Project, Rosetta Genomics is introducing a new era in the history of healthcare diagnostics and drug discovery - the microRNA Era.

 A Solid Platform for Success       Rosetta Genomics was founded in 2000 by a small group of visionaries who were among the very first researchers to recognize the potential of microRNA. Today, Rosetta has one of the world’s most experienced medical research teams dedicated to microRNA product development.

Though we are working in a relatively new field, our outstanding team has already achieved significant results in early-stage development, innovative technologies and intellectual property in microRNA.  Programs conducted at Rosetta Genomics include many of the earliest and most important initiatives in microRNA research – and the history of major developments in this field is still being written here today.

The company has made significant progress in efforts to advance a pipeline of promising microRNA-based therapeutic and diagnostic tools, including targets in oncology, infectious disease and other areas.

In addition, Rosetta believes its expanding intellectual property portfolio makes the company an optimal partner and collaborator for others engaged in microRNA product development.  With international reach, and a a team of talented scientists with extensive experience in all areas of genomic research and development, Rosetta Genomics is at the forefront of the rapidly expanding global healthcare focus on microRNA. In the years ahead, Rosetta plans to pursue multiple programs in microRNA product development, reflecting potentially significant commercial opportunities and important new programs in disease prevention and treatment for millions of people around the world.

The Rosetta Stone  

Rosetta Genomics takes its name from the Rosetta Stone, a large ancient stone engraving discovered by Napoleon’s troops in 1799 in a small village on the Nile Delta.

The Rosetta Stone includes sections of carved text presented in three different ancient scripts, including ancient Egyptian Hieroglyphics.

For the first time, thanks to the Rosetta Stone, researchers were able to decipher ancient Egyptian Hieroglyphics, thereby opening the Ancient World to modern eyes.

As the Rosetta Stone helped to decode the meaning of ancient texts, so Rosetta Genomics is dedicated to unlocking the mysteries of microRNA. We believe our efforts will help many others to understand this new “language” in healthcare and introduce a new generation of diagnostic and therapeutic products to improve human health.

19.08.2008 10:31
Rosetta Genomics Reports Second Quarter 2008 Financial Results

REHOVOT, Israel and JERSEY CITY, New Jersey, August 19 /PRNewswire-FirstCall/ -- Rosetta Genomics, (News) Ltd. , a leading developer of microRNA-based diagnostic and therapeutic products, reported today its consolidated financial results for the quarter ended June 30, 2008 and business highlights.

The company reported a 2008 second-quarter net loss of $3.7 million, or $0.31 per ordinary share. The second-quarter result compares with a net loss of $2.3 million, or $0.19 per ordinary share, for the corresponding quarter of 2007. Net loss for the six months ended June 30, 2008 was $7.6 million, or $0.63 per ordinary share, compared with a net loss of $4.3 million, or $0.41 per ordinary share, for the corresponding period of 2007.

"This has been a very exciting, and eventful quarter for us with the approval of the first test based on our microRNA technology and the acquisition of a CLIA-certified lab, both of which represent key milestones on our path to become a fully commercial company," said Amir Avniel, President and CEO of Rosetta Genomics. "The approval of the first test acts as strong validation to microRNA's ability to be utilized as powerful biomarkers, and we expect two additional tests - for differentiating mesothelioma from adenocarcinomas in the lung, and identifying the primary origin of a metastasis, to be submitted for regulatory approval in the coming months. In addition, we expect to begin development of tests at our newly acquired CLIA lab. Furthermore, the rapid progress in our development programs has allowed us to advance three additional cancer tests up our pipeline. These tests are focused on predicting response to ovarian cancer treatment, predicting risk of gastric cancer recurrence, and differentiating small cell from non-small cell lung cancer. Finally, we are moving three additional diagnostics up the pipeline: the first is being developed to detect the presence of colon cancer in serum, the second is being developed to detect the presence of bladder cancer, and the third is being developed to predict colon cancer risk of recurrence after surgery. Rosetta Genomics will continue its rapid pace towards commercialization of microRNA-based tests."

Financial Overview

Operating loss for the second quarter of 2008 was $3.5 million (including a non-cash expense of $295,000 related to stock-based compensation), compared with an operating loss of $2.7 million (including a non-cash expense of $282,000 related to stock-based compensation) for the corresponding quarter of 2007. Net loss for the second quarter of 2008 was $3.7 million, or $0.31 per ordinary share, compared with a net loss of $2.3 million, or $0.19 per ordinary share, for the corresponding quarter of 2007.

Net loss for the six months ended Jun 30, 2008 was $7.6 million (including a non-cash expense of $ 486,000 related to stock-based compensation), or $0.63 per ordinary share, compared with a net loss of $4.3 million (including a non-cash expense of $487,000 related to stock-based compensation), or $0.41 per ordinary share, for the corresponding period of 2007.

Research and development expenses of $2.2 million for the second quarter of 2008 and of $4.6 for the six months ended June 30, 2008, compared to $1.7 million and $2.9 for the corresponding periods of 2007, respectively, remain the company's largest expense and accounted for 62% of its operating loss in the second quarter of 2008.

As of June 30, 2008, we had $14.9 million in cash, cash equivalents, short and long term bank deposits, and marketable securities. Our outlook of total cash usage for operating activities for the remaining six months of 2008 is approximately $6 million. In July 2008 we paid $1.9 million in cash for the purchase of Parkway Clinical Laboratories, Inc.

As previously reported, due to the continuing uncertainty in the credit market, the company continues to impair its long-term investments in auction rate securities, which as of June 30, 2008, were valued at $1.8 million.

Recent Highlights

Rosetta Genomics reports the following scientific and corporate highlights:

Diagnostic Programs - "miRview"(TM) is the name chosen for upcoming tests to be developed and offered by Rosetta Genomics. - First test based on the company's microRNA technology, developed and validated by Columbia University Medical Center, approved for clinical use. The test, which differentiates squamous from non squamous non-small cell lung cancer (NSCLC) with sensitivity of 96% and specificity of 90%, has recently been approved by the New York State Department of Health Clinical Laboratory Evaluation Program. This test will be clinically available through Columbia University Medical Center's High Complexity Molecular Pathology Laboratory.

The ability of physicians to accurately differentiate squamous from non-squamous NSCLC is an important treatment guide. Bevacizumab, an angiogenesis inhibitor and an important new modality of therapy for non-squamous NSCLC, includes a black-box warning about substantially higher rates of severe or fatal hemorrhage among patients with squamous NSCLC histology compared with non-squamous NSCLC. In addition, several other targeted drugs for NSCLC currently under development may require this type of sensitive differentiation. Rosetta Genomics also plans to offer its own test, miRview(TM) Squamous, through its CLIA-certified lab.

- Mesothelioma vs. Adenocarcinoma - Differentiating between mesothelioma and adenocarcinoma is critical for optimal therapy, but it is often difficult to differentiate these tumors. Currently, there is no objective, standardized test to aid pathologists in differentiating between the many possible tumors in the lung and pleura. Based on a few microRNA biomarkers that were identified applying Rosetta Genomics' technology, a test is being developed to differentiate mesothelioma from adenocarcinoma tumors including lung adenocarcinoma and metastases to the lung or to the pleura. This test is expected to be filed for regulatory approval in H2 2008. In addition, Rosetta Genomics plans to offer its own test, miRview(TM) Meso, through its CLIA-certified lab. - Identifying primary origin of metastases (CUP) - Rosetta Genomics continued to advance assay development of a microRNA-based test for cancer of unknown primary (CUP). As demonstrated in a paper published by Rosetta Genomics and collaborators in the April issue of Nature Biotechnology, the test is being developed to distinguish among more than 20 possible tissues of origin, and it is expected to be submitted for regulatory approval in H2 2008. In addition, Rosetta Genomics plans to offer its own test, miRview(TM) Mets, through its CLIA-certified lab. - Additional diagnostic tests - We have advanced three new indications into development: - Predicting response to treatment of ovarian cancer patients - Platinum-based cytotoxic chemotherapy in conjunction with debulking surgery is currently the gold standard of treatment for patients with ovarian cancer. However, approximately 20-25% of patients do not respond to platinum-based chemotherapy and will require additional second-line treatment. Furthermore, research suggests that administering platinum-based treatment to patients who subsequently do not respond to it may actually hinder their response to the second-line treatment as well. Rosetta Genomics has identified unique microRNA biomarkers that may assist in identifying ovarian cancer patients expected to be resistant to platinum-based chemotherapy. - Predicting risk of gastric cancer recurrence - Recurrence after curative resection for gastric cancer is high and is estimated to occur in 80% of patients. This test is being developed to use microRNA biomarkers to predict the risk of recurrence for non-metastatic patients after resection of the primary tumor. - Differentiating small from non-small cell lung cancer - An estimated 220,000(1) patients are diagnosed with lung cancer each year in the U.S. alone. Before a patient begins lung cancer treatment, an experienced lung cancer pathologist must review the pathologic material. This is critical because small cell lung cancer, which is generally not treated surgically, can be confused on microscopic examination with non-small cell carcinoma(2). Rosetta Genomics has identified unique microRNA biomarkers that may be used to differentiate small from non-small cell lung cancers. - Biomarker Discovery - identified microRNA biomarkers in the serum of colon cancer patients which may serve as the basis for a future blood-based test for colon cancer. Corporate Development - Completed the acquisition of Parkway Clinical Laboratories Inc., a privately-held company owning a CLIA-certified lab located in Bensalem, Pennsylvania. The acquisition is expected to allow Rosetta Genomics to expedite development and validation of its microRNA-based diagnostic tests both in the U.S. and worldwide. In addition, ownership of the CLIA-certified lab will allow Rosetta Genomics to control the commercialization of its diagnostics, including marketing, sales, and reimbursement strategy.

The Company expects the first tests will be launched through the lab during Q4, 2008.

Collaborations and Licensing - Initiated a clinical validation study with The University of Texas M. D. Anderson Cancer Center. The study will focus on Rosetta Genomics' microRNA-based test that identifies the primary site of cancer of unknown primary (CUP) origin. The study will include one hundred patients who are diagnosed with CUP at M. D. Anderson, and who meet the eligibility criteria. - Initiated a research collaboration with The University of Texas M. D. Anderson Cancer Center and the Kleberg Center for Molecular Markers to develop a microRNA-based diagnostic test to predict risk of disease recurrence in lung cancer patients who have undergone curative resection. - Signed a collaboration agreement with the Rabin Medical Center in Israel to develop microRNA-based diagnostics in the fields of oncology, gynecology, and obstetrics. The collaboration will leverage microRNAs' significant potential as highly sensitive and specific biomarkers, to develop a wide range of diagnostic and prognostic tests. This is the company's first collaboration to include a focus on diagnostics for women's health indications. Publications - Published results of a study conducted by Rosetta Genomics' scientists and collaborators that describes the use of microRNAs in accurately differentiating primary from metastatic tumors of the brain. The results have been published online in the peer-reviewed journal Brain Pathology. The findings demonstrate microRNAs' significant potential to act as effective biomarkers that may be applied in a diagnostic test designed to identify primary tumors in patients with brain cancers. Conferences and Events Rosetta Genomics presented at the following conferences and events: - Collins Stewart Fourth Annual Growth Conference, July 2008, New York - American Society of Clinical Oncology (ASCO) Annual Meeting, June 2008, Chicago, Illinois Upcoming Conferences - AACR International Conference on Molecular Diagnostics in Cancer Therapeutic Development. September 22-25, Philadelphia, Pennsylvania. - Maxim Group Growth Conference, October 7th, New York. Conference Call Information

Rosetta Genomics will host a conference call at 08:30 a.m. ET today to discuss second-quarter activities and recent corporate developments. To access the live conference call, U.S. and Canadian participants may dial 1-866-966-5335; international participants may dial +44-20-3023-4460. To access the 24-hour audio replay, U.S. and Canadian participants may dial 1-866-583-1035; international participants may dial 44-20-8196-1998. The access code for the replay is 181543#. The replay will be available until August 26, 2008.

A live audio webcast of the call will also be available on the "Investors" section of the company's website http://www.rosettagenomics.com/. An archived webcast will be available on the Company's website approximately two hours after the event, and will be archived for 30 days thereafter.

About microRNAs

MicroRNAs (miRNAs) are recently discovered, naturally occurring, small RNAs that act as master regulators and have the potential to form the basis for a new class of diagnostics and therapeutics. Since many diseases are caused by the abnormal activity of proteins, the ability to selectively regulate protein activity through microRNAs could provide the means to treat a wide range of human diseases. In addition, microRNAs have been shown to have different expression in various pathological conditions. As a result, these differences may provide for a novel diagnostic strategy for many diseases.

About Rosetta Genomics

Rosetta Genomics is a leader in the field of microRNAs. Founded in 2000, the company'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 IP position and proprietary platform technologies, Rosetta Genomics is working on the application of these technologies in the development of a full range of microRNA-based diagnostic and therapeutic tools, focusing primarily on cancer and various women's health indications. The first microRNA diagnostic test applying Rosetta Genomics' technology has been approved for clinical use by the State of New York, and the company expects it will be launched by licensed clinical laboratories in the United States in 2008.

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, statements relating to the role of microRNAs in human physiology and disease, the potential of microRNAs in the development of therapeutics and diagnostic products, the progress and timing of our diagnostic and therapeutic programs, including the expected launch of the first diagnostic tests applying Rosetta Genomics' technology in 2008, and Rosetta's expected cash usage in 2008 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 risks related to: the continued uncertainty in the credit and capital markets that may result in these markets deteriorating further or Rosetta experiencing additional ratings downgrades on any ongoing investments in its portfolio (including on ARS); changes in the accounting treatment and final results for 2007 resulting from final third party valuations of the ARS; the current lack of liquidity of the ARS having a impact on Rosetta's liquidity, cash flow or its ability to fund its operations; other changes in general economic and business conditions; Rosetta's approach to discover and develop novel diagnostics products, which is unproven and may never lead to marketable products or services; Rosetta's ability to fund and the results of further pre-clinical and clinical trials; Rosetta's ability to obtain, maintain and protect the intellectual property utilized by Rosetta's products; Rosetta's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta's ability to obtain additional funding to support its business activities; Rosetta's dependence on third parties for development, manufacture, marketing, sales, and distribution of products and services; the successful development of diagnostic and therapeutic products applying Rosetta's technology, all of which are in early stages of development; Rosetta's ability to obtain regulatory clearances or approvals for products, as may be required under applicable laws; competition from others using technology similar to Rosetta's and others developing products for similar uses; Rosetta's dependence on collaborators; the ability to obtain coverage and payment from health plans and payers for diagnostic and therapeutic products applying Rosetta's technology and Rosetta's short operating history; as well as those risks more fully discussed under "Key Information - Risk Factors" in Rosetta's Annual Report on Form 20-F for the year ended December 31, 2007 on file with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosetta's views only as of today 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.

CONSOLIDATED STATEMENTS OF OPERATIONS U.S. dollars in thousands (except share and per share data) Six months Three months ended June 30, ended June 30, 2008 2007 2008 2007 Unaudited Unaudited Operating expenses: Research and development, net $ 4,571 $ 2,864 $ 2,182 $ 1,703 Marketing and business development.... 945 787 434 412 General and administrative............ 1,725 1,275 896 595 Operating loss....................... 7,241 4,926 3,512 2,710 Financial expenses(income) net........... 334 (655) 185 (455) Net loss......................... $ 7,575 $ 4,271 $ 3,697 $ 2,255 Basic and diluted net loss per Ordinary share . $ 0.63 $ 0.41 $ 0.31 $ 0.19 Weighted average number of Ordinary shares used to compute basic and diluted net loss per Ordinary share $ 11,929,689 10,374,298 11,939,107 11,857,447 CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (except share and per share data) June 30, December 31, 2008 2007 Unaudited ASSETS CURRENT ASSETS: Cash and cash equivalents.............................. $ 12,090 $ 13,590 Short-term bank deposits................................ 114 112 Marketable securities................................. 2,745 8,251 Other accounts receivable and prepaid expenses.............. 311 297 Total current assets................................. 15,260 22,250 LONG-TERM INVESTMENTS.............................. 1,760 2,391 SEVERANCE PAY FUND................................. 195 144 PROPERTY AND EQUIPMENT, NET......................... 1,311 1,253 OTHER ASSETS...................................... 115 - Total assets ....................................... $ 18,641 $ 26,038 LIABILITIES AND SHAREHOLDERS' EQUITY CURRENT LIABILITIES: Current maturities of capital lease and of long-term loan....... $ 112 $ 247 Trade payables.................................... 506 516 Other accounts payable and accruals...................... 915 1,102 Total current liabilities.............................. 1,533 1,865 LONG-TERM LIABILITIES: Long-term bank loan and capital lease..................... 39 16 Deferred revenue..................................... 228 228 Accrued severance pay................................. 381 324 Total Long-term Liabilities........................... 648 568 commitments and contingent liabilities SHAREHOLDERS' EQUITY: Share capital:...................................... 27 27 Additional paid-in capital............................... 59,503 58,984 Other comprehensive income............................ (3) 86 Deferred stock-based compensation....................... - - Deficit accumulated during the development stage............ (43,067) (35,492) Total shareholders' equity........................... 16,460 23,605 Total liabilities and shareholders' equity............... $ 18,641 $ 26,038 --------------------------------- (1) American Cancer Society website, 2008

(2) Travis WD, Colby TV, Corrin B, et al.: Histological typing of lung and pleural tumours. 3rd ed. Berlin: Springer-Verlag, 1999.

Contact: Investors Joshua Gordon, M.D. T: +1-201-946-0561 E: investors@rosettagenomics.com Media Ron Kamienchick T: +1-646-509-1893 E: media@rosettagenomics.com

Rosetta Genomics Ltd.

Q2 2008 Earnings Call Transcript       Rosetta Genomics Ltd. (ROSG)  

Executives  Joshua Gordon – Executive Director of IR  Amir Avniel – President and CEO  Tamir Kazaz – CFO and Corporate Secretary  Dalia Cohen – Chief Scientific Officer  Ronen Tamir – Chief Commercialization Officer  Ranit Aharonov – EVP and R&D Head of Computational Biology  Raza Bokhari – Chief Development Officer  Analysts  Kevin Degeeter – Oppenheimer  Pamela Bassett – Cantor Fitzgerald  Richard Terry [ph] – Constitute Research [ph]  Presentation  Operator

 Good morning, ladies and gentlemen, and welcome to the Rosetta Genomics 2008 second quarter earnings call.

Today’s call is being recorded and will be available for 30 days on the company’s website. At this time all participants have been placed in a listen-only mode. In the floor will be open to questions following the presentation. 

 It is now pleasure to turn the call over Dr. Joshua Gordon. Dr. Gordon assume the position of Executive Director of Investor Relations of Rosetta Genomics, sir you may begin.  

Joshua Gordon      Thank you and welcome everyone to our second quarter earnings call. Today I am joined by Amir Avniel, CEO of Rosetta Genomics and Tamir Kazaz our Chief Financial Officer, Dalia Cohen, our Chief Scientific Officer; Ronen Tamir our Chief Commercialization Officer and Dr. Raza Bokhari, our Chief Development Officer will join us for the Q&A.

 Rosetta Genomics release it financial results for 2008 earlier this morning.

Before we begin I would like to state that some of the information presented here today may contain projection or other forward-looking statements regarding future events or the future financial performance to company.  

These statements are based on management’s current expectations and actual events or results to may differ materially and adversely for these expectations for variety of reason. We refer you to the documents the company files from time-to-time with the securities and exchange commission specifically the company’s annual report on Form 20-F and reports on Form 6-K.  These documents identify important risk factors that could cause the actual results to differ materially from those contain in our projections or forward-looking statements. Join today’s call we will discuss major events that have taken place at Rosetta Genomics during the second quarter of the year. Amir will present the quarters business highlights advancements in R&D and marketing development.  Tamir will then discuss the quarter’s financial results. Finally we will open the call for Q&A, and now I would like to turn over the call to our CEO, Amir Avniel. Amir.  Amir Avniel  Thank you Josh, it has been an exciting quarter for Rosetta Genomics and one with many milestones.

The most notable achievement for the quarter was the Columbia University Medical Center receives regulatory approval for the first Molecular Diagnostics for that they develop based on our technology. A bigger validating step for Rosetta Genomics on a confirmation of the ability to use our technology to develop on Molecular Diagnostics product from start to finish.  In general we accomplish another significant milestone with the acquisition of a CLIA-certified testing laboratory with 34 employees and $2.7 million in expected revenue in 2008. The acquisition of this lab is expected to allow us to rapidly develop and validate our diagnostic testing in-house and become a fully commercial company’s in the fourth quarter of 2008.  The last important milestone achieve this quarter is our success in moving multiple new diagnostics at our five plans which is a validation of our microRNA products engine. This new tests have the potential to address unmet medical needs for gastric, bladder, colon and lung in ovarian cancer. We will continue pushing forward this more oncology indications an additional indication for genetic disorder in women’s health and expect to announce more indications in the following quarter.  All this strength of our conviction that using microRNA as biomarker with our technology may significantly impact the Molecular Diagnostic forward. We anticipate releasing more new products during 2009 and 2010 and hope to dramatically influence the way medicine is practice today. I will now comment on some of these events in more detail.

Beginning with our acquisition of Parkway Clinical Laboratories in Pennsylvania, Parkway specializes in conducting clinical diagnostics tests and handles in excess of 170,000 specimens are used is an estimated $2.7 million in annual revenue.  Parkway is expected to breakeven in 2008. The acquisition of CLIA-certified lab will allow Rosetta Genomics to expedite and gain full control over the in-house development, validation, commercialization, marketing and sales of our microRNA based diagnostics tests. During the last month we expanded the lab to 11,000 square feet’s by adding a second location in Philadelphia where we are installing our proprietary microRNA based diagnostics technology. We started the calibration of this lab and believe it will be fully operational shortly.

We expect that the third diagnostics test developed and validated by us will be commercially available through this facility in Q4 2008. Parkway have 34 employees, we support the labs daily operations, marketing and distribution. These employees will now be incorporated into Rosetta Genomics discount which will now consist of 103 employees. The CEO of the labs Dr. Raza Bokhari joint Rosetta full time of Chief Development Officer and I would like to take this opportunity to extent a very warm welcome to Raza and the rest of his team on behalf of Rosetta Genomics.  Second important event in this quarter was the regulatory approval by the New York State Department of Health of the first ever microRNA diagnostic tests for clinical use that was developed and validated by Columbia University Medical Center based on Rosetta Genomics technology. The goal of these tests is to differentiate between two types of non-small cell lung cancer that are treated very differently. It is common today to treat advance non-small cell lung cancer, the more common of them two main form of lung cancer is the targeted molecular therapy avastin, an angiogenesis inhibitor.  By avastin concludes seriously than in over 30% of patients with subtype of lung cancer called squamous cell carcinoma. Therefore a great need for accurately differentiate between squamous and non-squamous non-small cell lung cancer.

We believe this diagnostic product can help change the way lung cancer is treated today by defining the exact group of patients who may benefit the most from these targeted therapy. This is an example of personalized medicine, which is exactly what our diagnostic product are all about.  As I mentioned, receiving regulatory approval for this product from the New York State Department of Health by Columbia University Medical Center is a great validation and a step forward for Rosetta Genomics and we believe it will supports the validation and approval of the tests that will be launched from our own lab. In order to obtain regulatory approval Columbia University Medical Center use it should be chords in a blinded trial, using a single microRNA with two controls.

 Columbia’s validation demonstrated 96% sensitivity and 90% specificity. We presented the information at the most recent ASCO conference in a paper describing this test while submitted for publication. Columbia is expected to offer test based on our technology later this year and we also expect to develop our own version of this base in our Philadelphia lab and introducing to the market later this year.  We also give these tests as having a strong formal economic relational to payers due to the high cost of the current goals standard therapy by providing them with the first ever of objective and standardized tests for this indication, with a market size, approximately 60,000 patients a year in the U.S. alone in an estimated price of $3000 for this test, we believe that this product as a significant market potential.  Once the product is on the market we then to start conducting multiple side trial in order to generate more data on our lung cancer and other tests and to create broad awareness in speed adoption of our test in one pathologists and oncologists, we have already received great feedback from the expert lab oncologist we approach during the development and validation profits and are continuously advice that there is a great need for this product.  One of our strongest assets is our unique product engine, the capability to discover and develop multiple microRNA diagnostic products at the same time. We expect second tests resulting from our product engine to be commercialized this year, one that will identify origin of RETOSIS and up to 90,000 cases a year in the U.S., RETOSIS are discover but anthologies can not determine where their regional tumor is located.  As a result this patient cannot get tumor specific therapy in broad or tried in narrow therapies open initiated and ineffective and costly end use. To mitigate this problem Rosetta Genomics is developing a test that identified more than 20 types of cancer based on the each tumor unique microRNA fingerprint.  The test can precisely and objectively identify the original for metastasis and is called miRview, miR from microRNA and med from metastasis. With a market of 90,000 patients in the U.S. alone in a target price of 3500 receive we see this product as having the potential becoming Rosetta Genomics leading revenue producing products in 2009.  In our recent article published in the April 2008 addition of Nature Biotechnology. We demonstrated that we can determine the origin of metastasis was 89% accuracy. Following the publication we’ve received great feedback from both physicians and patients. So we are very proud of seen use of hard work bearing fruit and of – addressing this very important unmet needs, CNC not offered test commercially and due to regulatory approval we are referring patients who contact us while our collaborators with whom we are working to validate this test. So they may have an opportunity to participate in the validation study.  We announced last week that Rosetta Genomics will collaborate with leading academic institutions in the prospective clinical validation study with 100 patients before they’re demonstrates the effectiveness of this metastasis identification product. We expect to be able to publish the result of this work during 2009.  We anticipate conducting many more similar studies for all our products in collaboration with leading instituting in the near future and our diligently working to advance such agreements.  Finally the third products related for release this year will help oncologist and pathologist differentiate between mesothelioma and asbestos induce cancer and in various adenocarcinomas in the lung or (inaudible), this will enable position to direct the best therapy to the patients. As you know Rosetta Genomics mission is to become one of the leaders in the Molecular Diagnostic space.  Our goal for 2009 to bring more innovative Molecular Diagnostic product to market and to achieve dominant Molecular Diagnostic position, we already announced that we are on the verge of commercializing the three product they mentioned about, but we are also advancing development with three other, predicting the response of chemotherapy in ovarian cancer, determine the risk of recurrence of their gastric cancer section and differentiating between the two most common type of lung cancer small and non-small cell lung cancer.  The first of this year designed to predict the response of ovarian cancer patient to treatment is platinum-based chemotherapy to approximately 190,000 cases per year of ovarian cancer worldwide and 22,000 cases in the U.S. platinum-based chemotherapy in conjunction with the bulking surgery is currently the gold standard for treating ovarian cancer patients.  However, approximately 20% to 25% of patients do not respond to platinum-based chemotherapy and require additional second-line treatment. Administering platinum-based chemotherapy to patients who will ultimately not respond may take up several pressures amount from them and its costly treatment. Furthermore, there is research that suggests that administering platinum-based treatment to patients who subsequently do not respond to it may actually hinder their response to the subsequent second-line treatment.  To address this need we have identified unique microRNA biomarkers thus we believe we will assist in identifying ovarian cancer patients expected to be resistant to platinum-based chemotherapy. The second test is designed to predict the risk of gastric cancer recurrence, today’s goal standard treatment for most gastric cancer patients include the effective surgery followed by chemotherapy.  Gastric cancer recurrence after surgeries estimated to a current 50% to 80% of patient as physicians cannot predict, which patient will have recurrence the common practice in the U.S. is to administer adjuvant chemotherapy following surgery. These type of one size fits all treatment maybe unnecessary for some patients and may significantly damaged their quality of life. We have identified microRNA biomarkers to predict the risk of recurrence for non-metastatic patients after resection of the primary gastric tumor.

 Patient, are identified as they having low for ability of recurrence may not benefit from post operative chemotherapy. They are approximately 900,000 cases gastric cancer worldwide and 22,000 cases in U.S. and we expect to the price will be $700,000. We believe this test may significantly improve gastric cancer patients cure management around the world.  The third test which address, the largest market will be designed to differentiate small from non-small cell lung cancer. Lung cancer is a most common cause of cancer related different men and women. We have estimate it 215,000 patients diagnosed, if lung cancer each year in the U.S. alone. Non-small cell lung cancer accounts were 80% to 85% of cases. Before our patients begin treatments and experience lung cancer pathologists must review the pathological material taken from the tumor.  We have identified unique microRNA biomarkers that are maybe used to differentiate small from non-small cell lung cancers. This is a critical, because small cell lung cancer can be confused on microscopic examination with non-small cell carcinoma. Again this is one way example for Rosetta Genomics participation in the new word of personalized medicine using an objective test based on microRNA to differentiate on a molecular level between two type of lung cancer that are treated very differently.

 Moving on, we are pleased to announce that the advancement in three additional diagnostic test. I will touch on this briefly, the first of these test is being developed to detect the presence of colon cancer by identifying microRNA signature in the patient’s serum using a simple blood test. This test as enormous market potential considering the fact that doctor recommend routine colon cancer screening for all people over a 50 and started to show that compliance for these recommendation is low. Having at this that can identify high risk patient may increase the compliance for colonoscopy exam and we help in increase early detection of this deadly disease.  Second test is being developed to taking the risk of Superficial Bladder Cancer becoming invasive and third test is being developed to predict colon cancer risk of recurrence. We are planning to hold an investors day in November, where we’ll elaborate on these tests.

If you wish to be notified on details for this event, please contact Dr. Joshua Gordon at our New Jersey office.  One of the goals for our academic collaboration is to validate our technology and publish our resulting peer-reviewed journal. We recently announced the publication of once such study in journal Brain Pathology in the study of Rosetta Genomics Scientists and collaborator described the use of microRNA and accurately differentiating primary from Metastatic Brain Tumors.  This study is yet another demonstration of the diagnostic potential microRNA hold in one of our sensitive and effective microRNA technologies. We expect additional studies to be published during the coming month. Beside journal publication we have been busy presenting research abstracts at multiple conferences such as ASCO and AACR in our advance and research collaborations with some of the most prestigious academic institutes in the world.  The significant advancement of the nine diagnostics test coupled with multiple new high-caliber academic alliances and publications puts Rosetta Genomics in a great position to continue lead in the microRNA revolution. As we prepare for the certification of our clinical laboratory in Philadelphia we are simultaneously gearing up to finalize the transformation of our company into a full commercial entity.  Based on our markets research conversation with stakeholders and analysis of lesson learned from various commercial models of other Molecular Diagnostic companies. We decided to approach the market using the model normally used by lot of pharmaceutical companies. We will soon start recruiting the sales team that will approach selected group of physicians in a structure in a metabolic way.  We plan to spend the time from now until launch of our first products recruiting our sales force which will undergo extensive training, covering all aspects of our products including the disease pathway current Diagnostic and therapeutic gold standards and the competitive advantages offered by our test.  The initial sales forces will cover major urban areas to maximize efficacy and we will grow a numbers as our products come to be adopted by the medical community. At the same time we understand that reimbursements is critical to the commercial success of our products and are therefore in the process of recruiting a dedicated reimbursement and manage market teams to negotiate and secure reimbursement for our product. With that I would like to pass on the microphone to our CFO Tamir Kazaz who will discuss this quarter’s financial results. Tamir  Tamir Kazaz  Thank you, Amir, and good morning everyone. I would now review the consolidated financial results that we published this morning. Operating loss for the second quarter of 2008 was $3.5 million, which included a non-cash expense of 295,000 related to stock-based compensation. Compared with an operating loss of $2.7 million for the corresponding quarter of 2007, which included a non-cash expense of 282,000 relates to the stock-based compensation.  Net loss for the second quarter of 2008 were $3.7 million or $0.31 per ordinary share compared with the net loss of $2.3 million or $0.19 per ordinary share for the corresponding quarter of 2007. Net loss for the six month ended June 30, 2008 were $7.6 million or $0.63 per ordinary share, which included a non-cash expense of 486,000 relates to stock-based compensation compared with the net loss of $4.3 million, which included a non-cash expense of 487,000 relates to stock-based compensation or $0.41 per ordinary share for the corresponding period of 2007.  Research and development expense of $2.2 million for the second quarter of 2008 and $4.6 million for the six month ended June 30, 2008 compared to $1.7 million and $2.9 million respectively for the corresponding period of 2007. Research and development remains the company’s largest expense and accounted for 62% of its operating losses. As of June 30, 2008 we had $14.9 million in cash, cash equivalents short and long-term bank deposit and marketable securities.  In July 2008 we’ve face $1.9 million in cash for the purchase of Parkway Clinical Laboratories Inc., and our outlook of total cash usage for operating activities for the remaining six months of 2008 is approximately $6 million. As previously reported due to the continuing uncertainty in the credit market the company continues to incur its long-term investment in auction rate securities, which as of June 30, 2008 we are valued at $1.8 million.  I will now return the call back to Amir Avniel. Amir  Amir Avniel  Thank you, Tamir. Before our first microRNA technology approved for clinical use and acquisition of CLIA-certified Laboratory, Rosetta Genomics is in the final stage of transforming into our commercial diagnostic company by continuous advancing new indication up our pipeline we expect the upcoming month to be exciting and contribute significantly to the commercial growth of the company. I would now like to turn the call over to the operator and ask for our question.  Question-and-Answer Session  Operator  Thank you. (Operator instructions) The first question comes from the line of Kevin Degeeter from Oppenheimer, please go ahead.  Kevin Degeeter – Oppenheimer  Yes.

Good morning, thank you guys. Hey one quick financial question is I may at the top then maybe some questions regarding the sort of pre-launch activities. Perhaps if you can better help us to better understand the financial guidance in terms of use of $6 million for the remainder of the year.  One point of clarification, assuming that includes or excludes the acquisition of Parkway and secondarily could you just help me understand a little more clearly, I mean guess that some implies a decline in the cash burn rate for the second half of the year when we would expect, with the pre-launch activity that the market line will be going up. So perhaps you could talk a little bit about just marketing expenses, going into the launch as well.  Tamir Kazaz  Sure, I think Avniel, you could start and I will continue the answer.  

Amir Avniel  Thanks Tamir. Yes, Kevin obviously when we’re going to start the recruitment and start getting recruiting the people that and start paying for them being on our payroll even if theorize in our marketing and sales expenses, but having said that we believe that this is the good investment, that should be done for the company and eventually it’s going to yield a productive return.  Now regarding the timing of that, I think we’re not in the position right now to disclose that, but having said that if we’re planning for the first quarter to be launched on the fourth quarter. You need to assume that couple of weeks before that, we will need to have everybody on board in order to go through the training and all the other activities that I may have mentioned during the call. Tamir.

Tamir Kazaz  Yes, so as Avniel mention definitely the focus of the company is now moving more to the commercialization and as I mentioned we will recruit some sales force and we’ll prepare our sales to launch the products and some resource will go after that. We don’t expect right now at this point to increase significantly the burn rate monthly of our company.  Kevin Degeeter – Oppenheimer  Okay.

I guess that’s helpful and sort of on the reimbursement front, can you give us a sense as to how you expect the products to be sort of reimburse that at the box and sort of at launch and just see how your preliminary discussion where payers have gone in terms of there comfort level with the kind of $3,000 to $4,000 price point that’s been suggested as a reasonable range for these test.  Tamir Kazaz  Yes Ronen, please.  Ronen Tamir  Yes, so regarding our discussion with the reimbursement agencies, during our market research we interviewed our third-party, interviewed then the blended basis, then Medical Directors of the top national coverage Managed Care Companies and I have to say that they had a very positive attitude regarding the reimbursement and the acceptance these type of technology into their offering.  I think that moreover they run the companies that launch before us High Complexity Molecular test has done a great job, both in explaining the technology and the value behind such a technology as well as in gaining the market understand that the price tag of $3,000 to $4,000 per test, it has a fair value to what it brings into the both the managing of the Pharmacoeconomics patients reserve that from microeconomics behind it.  We believe that each of our products has a very strong Pharmacoeconomics rational behind it, if we talk about treatments like Bevacizumab, which costs about a $105,000 or CUP diagnostic, which cost probably over $20,000 today. We believe that we can contribute an oncology from microeconomic way as well as contribute to the well-being of the patients and helping the doctor, treat that patient, which all are to goal of Managed Care Organization. So, during market research they were very positive about that and they were not surprised to the price trend.  Kevin Degeeter – Oppenheimer  Okay. Great, congratulations. I’ll get back in queue.  Ronen Tamir  Thank you.  Operator  The next question comes from the line of Pamela Bassett with Cantor Fitzgerald. Please go ahead.  Pamela Bassett – Cantor Fitzgerald  Hi, thank you very much and congratulations on your progress. Can you hear me, okay

?  Amir Avniel  Yes, thank you Pamela.  Pamela Bassett – Cantor Fitzgerald  Can you tell us how the accuracy if say the first retests that you’re planning to launch compare to the current standard of care with respect to accuracy in sensitivity?  Amir Avniel  Yes, definitely. Dalia  Dalia Cohen  Sure. If we start with this squamous and non-squamous we’ll have all 90% sensitivity and specificity of today that are some antibody, which will be in use to identify squamous and non-squamous. We all know that, but they are not specific for the tissue type.

In addition it is very subjective to looking into the microscope and subjected to the pathology who is reviewing those slides.  For the cancer of unknown primary that’s even we have again over 90% specificity and accuracy and again we know today from living physician pathologist that the antibody again and they are looking under the microscopic subjective the antibody are not specific and with all the other test, basically one look on these as a puzzle, which pieces which are not matching and there is no way of today to do it.  

So, identify accurately their origin of metastases. So, the mesothelioma compare to other metastases into the lung or the pleural again we will think about very low specificity of metastases of antibody looking under the microscope and trying to identify their origin of those metastases into the lung the pleural, and with looking in the microscope so we believe that I will give a standard way to identify tissue origin and the tissue specific metastases.  

Ranit Aharonov   I think if I can add on that the all those three test that’s we are planning to bring into the market this year all of them the specificity and the sensitivity is above 90%. The current standard right now as Dalia mentioned is some subjective test mostly morphology and histology that they Pathology is using to look under the microscope. 

 We know there are research for example Diagnosed Pharma are showing that they’re agreement within different pathologies is between 60% to 70% in the case of differentiate between (inaudible). On the CUP, as Dalia mentioned there is not exactly government standards right now that we can compare ourselves because the most oncologist and pathologists that’s we’re taken with they have after which become CUP that’s what they call it, they call it cancer of unknown primary and we don’t know what to do with that. So, in that sense there is nothing to compare and we believe that our product can come and change these dogma. There are some products for the CUP that is now available in the market, but we are not sure what their specificity and sensitivity they’re there.

www.rosettagenomics.com

Ich hoffe das liegt nicht am Namen ;)

http://www.nasdaq.com/symbol/rosg/real-time

 

Aktiensplit 1:15 am 15.5.
+ news out
dann KE-news zu 3,50 USD rausgehauen.
Teil steigt
wieso? wohin?  

 

ich hab auch ein paar solche ROSG's und hab die damals für 0.26 Cent eingekauft, dann haben die neue Aktien für 0.17 Cent ausgegeben (die spinnen die Israelis, zum halben aktuellen Preis. Ist im Fall nicht rassistisch zu werten :-) ). Dann ging's nochmals runter auf 0.14 und dann die Zusammenlegung 1:15.
Und kurz danach, gerade als die besten News kamen und der Titel massiv performte (ca. 380%) wurden meine Titel gesperrt bis heute. Gestern das Hoch bei 8.11 USD, man das ist übel für einen Trader.
Also ich denke, die gehen noch höher nach solchen News vom 16.5. oder was haltet ihr davon?  

das läuft ja wie ich mir es vorstelle, tolle Performance, da wird noch voll zugekauft, das Ding geht noch über 8 USD.
Wünsche eine tollen Abend und keep cool :-) Monster  

bin gespannt, ob sie wieder auf den Kurs der KE von 3,50 USD zurück kommt.  

 

ich hab es gesehen und mir selber nicht geglaubt, also warten auf Rücksetzer.
Was meint ihr, kommt die ROSG nochmals runter oder steigt das Ding bis auf 17 USD?  

habe dennoch die Hälfte mit 50 % plus rausgenommen, Rest kann gerne weiter durch die 10 zur 17 laufen.  

ich hab meine gestern noch zu 7.50 verkauft - mit gutem Gewinn, wobei es ist ärgerlich, gerade vor so einem Schub.
Mein Bauchgefühl sagt mir, dass morgen ein Rücksetzer kommem muss, wobei die kaufen noch immer wie wild bei 9.90 USD.
Ein Kaufrausch ist besser als jede Droge, unglaublich. Geht vieleicht noch heute auf 50%.  

hab heut den Teilverkauf zu 9,34 gemacht, kauf 6,24,
aber monster, du hattest ja einen viiieeeel besseren Einstiegskurs, Glückwunsch!
Rest bleibt drin, kann ich hoffentlich kaum noch ins minus laufen, insgesamt, selbst wenn
die auf die 3,50 KE zurückkommen.  

wobei manchmal ist ein kleiner Verlust weniger schmerzvoll, als ein nicht geholter Gewinn.
Ich hab die Teile vor Wochen noch für 0,322 Cent gekauft, entspricht einem Kurs von 4.83 nach der Zusammenlegung. Nach dem Split waren sie ja zu 2.10 und am selben Tag zu 1.62 zu haben.
Na dann Dir viel Glück, ich werde ev. nach einem Rücksetzer, oder zwei wieder einsteigen.
Gruss Monster  

Morgen gäbe  

KE zu 3,50 USD mit rd. 600 K,
verschenkt, wie konnte man die zeichnen?  

zum Schluss erneut durch die 11 gegangen ist unter wirklich ansprechendem Vol.,
war mein Teilverkauf heut wohl ein Fehler.
Bei der Kaufpanik würde mich morgen das Durchziehen der 15 jedenfalls nicht wundern.
Zusehen und genießen, hopefuly.  

was meinst du, geht der Hype heute weiter? Nachbörslich bis 12.30 USD, wobei nur sehr kleine Volumen zu dem hohen Preis gehandelt wurden. Nachbörslich aber immer noch 5% höher bei 11.81 USD - ich denke da treiben einige bewusst den Kurs hoch. Auffällig sind auch die vielen kleinen Order à ja 100 Stck.

Ich denke es geht weiter so, heute - und Morgen dann der letzte Streich (up und ins minus), Gewinne zum Wochenende, warum auch nicht.
Schon komisch, meine Prognosen treffen fast immer zu, zumindest dann, wenn ich keine Teile mehr im Portfolio habe :-((  

die wollen alle dickes Fett sehen am Schwein, wie mich mein Gefühl die Wahrheit flüstert.
Die Aktie geht noch vor Eröffnung über die 15 hinaus.....Poahhh  

 

 

http://phx.corporate-ir.net/...sArticle&ID=1696433&highlight=

Die Aktie steigt bis zum abwinken......  

im nächsten Leben werde ich Börsenguru aber ich werde keine Aktien mehr kaufen, sonst klappt das nicht. Ich glaube ich werde noch psychotisch....???
Der Kurs übertrifft sogar meine Erwartungen.  

ist die Party wohl vorbei....so long