Clinical Data Reports Strong Performance During Fiscal Second Quarter.-Company Continues to Achieve Operational and Strategic Milestones and Remains On-Track to Achieve FY 2008 Goals- -Cogenics Revenue Grows 22%; PGxHealth Revenue Grows 17%- -Investment in Vilazodone to Increase Following Successful Outcome of Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA Pivotal Trial- -Company Completes Divestiture The breakup of AT&T. By federal court order, AT&T divested itself on January 1, 1984 of its 23 operating companies, which became known as the Regional Bell Operating Companies (RBOCs). of In-Vitro Diagnostics Businesses- -Cash On Hand is Now Approximately $80 Million- NEWTON, Mass. -- Clinical Data, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CLDA CLDA California Lyme Disease Association ), which is focused on developing new predictive tests and targeted therapeutics from its growing portfolio of proprietary genetic biomarkers, today reported strong results for the Company's fiscal second quarter ended September 30, 2007, and significant progress against its key milestones. "During the fiscal second quarter, our team continued to achieve our operational and strategic milestones," said Drew Fromkin, Clinical Data President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "As a result, Clinical Data continues to emerge as a global leader in developing and commercializing proprietary pharmacogenetic tests and targeted therapeutics to reduce healthcare costs and improve clinical outcomes. Our fiscal second quarter performance was highlighted by strong revenue growth from our Cogenics and PGxHealth product lines. In addition, we significantly expanded our intellectual property portfolio with the acquisition of Epidauros Biotechnologie AG, increased investment in our most strategic assets and continued to effectively manage expenses. Further, we have completed the divestiture of all of our in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. diagnostic businesses to focus exclusively on our most strategic operations." "We recently reported positive results from the Phase III pivotal trial of Vilazodone, our unique, dual mechanism antidepressant antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy. drug candidate. This trial met both primary and secondary efficacy endpoints and identified promising novel genetic biomarkers for the prediction of patient response to Vilazodone. Our success in this clinical trial has signaled a strategically important moment for the Company by validating our ability to independently advance late-stage drug candidates, and by demonstrating our expertise in identifying and advancing proprietary genetic biomarkers for drug response." Highlights of the Fiscal Second Quarter In the fiscal second quarter ended September 30, 2007, Clinical Data achieved the following milestones. Development of Targeted Therapeutics * Announced positive results from the Phase III pivotal study of Vilazodone, the Company's candidate drug for depression, which represents a new class of antidepressant. The study also identified proprietary candidate biomarkers for a potential companion pharmacogenetic test of a patient's response to Vilazodone. * Advanced planning for the initiation by fiscal fourth quarter of Vilazodone's long term safety program and second Phase III trial. Expansion of Biomarker Product Line * Launched a sales force focused on healthcare providers to increase the adoption of the FAMILION[R] family of tests for the diagnosis of cardiac channelopathies, and PGxPredict[TM] tests, which use genetic markers genetic marker n. A gene phenotypically associated with a particular, easily identified trait and used to identify an individual or cell carrying that gene. to help doctors make more targeted treatment choices by predicting a patient's response to specific drugs. * Launched a new test in October for Catecholaminergic Polymorphic Ventricular Tachycardia Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) is an inherited heart rhythm disorder caused by a mutation in voltage gated ion channels and resulting in arrhythmias. (CPVT CPVT Catecholaminergic Polymorphic Ventricular Tachycardia ) mutations, which may be the most lethal of the inherited cardiac channelopathies. This test is a member of the FAMILION family of genetic tests. * Established a program with George Washington University George Washington University, at Washington, D.C.; coeducational; chartered 1821 as Columbian College (one of the first nonsectarian colleges), opened 1822, became a university in 1873, renamed 1904. to examine the patient safety and clinical utility of the PGxPredict test for warfarin warfarin (wôr`fərĭn), anticoagulant used to treat blood clots. In large doses it causes bleeding. Warfarin, mixed with bait, is used in rodent control. warfarin Anticoagulant drug, marketed as Coumadin. in the orthopaedic practice setting. * Continued to invest in automation, information system upgrades and other key resources to increase capacity and reduce the cost-per-test in the Company's two CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a certified laboratories. Execution of Strategic Transactions * Acquired Epidauros Biotechnologie AG of Bernried, Germany, in a cash transaction valued at 8.75 million euros (or approximately $11.9 million) in August 2007 that significantly expanded Clinical Data's intellectual property portfolio. Epidauros also brings to Clinical Data additional expertise in genetic biomarker discovery Biomarker discovery is the process by which biomarkers are discovered. It is a medical term. Many commonly used blood tests in medicine are biomarkers. The way that these tests have been found can be seen as biomarker discovery. , relationships with leading diagnostic companies, a fast-growing pharmacogenomics Pharmacogenomics is the branch of pharmacology which deals with the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with a drug's efficacy or toxicity. services business, and an established portfolio of proprietary genetic biomarkers relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc such prominent drug transporters as MDR MDR, n See multidrug resistance. MDR, n the abbreviation for minimum daily requirement, specifically the Minimum Daily Requirements for Specific Nutrients compiled by the United States Food and Drug Administration. 1 and to drug metabolism Drug Metabolism/Interactions Definition Drug metabolism is the process by which the body breaks down and converts medication into active chemical substances. Precautions Drugs can interact with other drugs, foods, and beverages. , such as CYP2B CYP2B Cytochrome P450 2B 6. * Raised $71.4 million from a secondary public offering completed in July 2007 that included the exercise of the underwriters' over-allotment option. In addition, since the second quarter ended, Clinical Data has sold its remaining in vitro diagnostic businesses Vital Scientific, BV and Electa Lab s.r.l. for $19.5 million and $2.5 million, respectively. These transactions complete the Company's year-long strategy to divest its in-vitro diagnostics businesses so that it can focus on further developing its IP-driven pharmacogenomics tests and targeted therapeutics as well as its genomics services division. These businesses have been classified as discontinued operations Discontinued operations Divisions of a business that have been sold or written off and that no longer are maintained by the business. . Financial Results Total revenues from continuing operations continuing operations Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the for the fiscal second quarter of 2008 rose 25% to $9.1 million from $7.3 million for the three months ended September 30, 2006. Cogenics revenue for the fiscal second quarter of 2008 rose 22% to $7.7 million from $6.3 million in the fiscal second quarter of 2007. This revenue includes $1.8 million of grant revenue from Icoria product lines that are expected to wind down by December 2007. PGxHealth revenue rose 17% during this period to $1.1 million versus $968,000 during the fiscal second quarter of 2007. Within the PGxHealth division, the FAMILION family of tests for the diagnosis of cardiac channelopathies rose 23% versus the fiscal second quarter of 2007. The development of a new PGxHealth sales force at the end of the fiscal second quarter included the hiring of 10 new sales representatives and senior level sales and marketing management. "As we grew our business during the quarter, our team continued to focus heavily on managing Clinical Data's cash resources," said Evan Ballantyne, Clinical Data Senior Vice President and CFO See Chief Financial Officer. . "As we move into the second half of our fiscal year, we remain committed to driving revenue growth and investing in our strategic businesses. For example, given Vilazodone's positive clinical results, we expect to devote increased R&D resources to this exciting drug candidate during the second half of the year and through fiscal 2009. We finished the quarter with cash and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has totaling $61.1 million. This figure excludes the proceeds from the sale of our Vital Scientific and Electa Lab businesses for $19.5 and $2.5 million, respectively, which we realized in the fiscal third quarter. As of the date of this release, Clinical Data has approximately $80 million in cash and cash equivalents." For the three months ended September 30, 2007, the Company reported a loss from continuing operations of $9.8 million compared to a loss of $8.2 million in the same period a year ago. The loss at September 30, 2007 included non-cash items related to depreciation, amortization and stock based compensation totaling $4.3 million and research and development expense totaling $2.9 million primarily related to the Vilazodone clinical trial and related biomarker test development. For the same period a year ago non-cash items related to depreciation, amortization and stock based compensation totaled $4.0 million, and research and development expense primarily related to the Vilazodone clinical trials process totaled $3.2 million. For the three months ended September 30, 2007, the Company reported a basic and diluted loss of $0.51 per share from continuing operations compared to a basic and diluted loss of $0.56 per share for the same period a year ago. Basic and diluted weighted average shares outstanding were 19.2 million at September 30, 2007 and 14.4 million at September 30, 2006. Outlook for Fiscal 2008 "We have transformed Clinical Data into a company now focused on leveraging its growing portfolio of proprietary genetic biomarkers for drug response into new predictive tests and targeted therapeutics," added Mr. Fromkin. "Our goals for the year remain unchanged. We aim to generate combined revenue growth during the full fiscal year for our Cogenics and PGxHealth product lines of 20 to 25 percent while continuing to be good stewards of our cash. Furthermore, we expect to continue to improve the bottom line performance of Cogenics while investing even more aggressively in the development of the intellectual property held by PGxHealth and related products and services. The positive Phase III pivotal results for Vilazodone will mean an increase in costs associated with the initiation of our planned follow-on Phase III confirmatory trial and safety trial with continued focus on an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any submission in 2009. With success, Vilazodone will participate in an over $12 billion depression drug market in the US." About Clinical Data, Inc. Clinical Data, Inc. is unlocking the potential of molecular discovery from Targeted Science to Better Healthcare(TM). Its PGxHealth(TM) division focuses on proprietary biomarker and pharmacogenetic test development as well as targeted therapeutics to help predict drug safety and efficacy, thereby reducing health care costs and improving clinical outcomes. Its Cogenics(TM) division provides genomics services to both research and regulated environments. Through these divisions, Clinical Data is leveraging advances in molecular discovery to provide tangible benefits for patients, doctors, scientists and health plans worldwide. Visit the company's website at www.clda.com for more information. SAFE HARBOR Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and OF 1995 This press release contains certain forward-looking information about Clinical Data that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to statements regarding: our ability to successfully introduce our new pharmacogenetic and molecular diagnostics products and services; our ability to expand our long-term business opportunities; our ability to maintain normal terms with our customers and partners; financial projections and estimates and their underlying assumptions; and statements regarding future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to: whether our PGxPredict[TM] pharmacogenomics tests and Cogenics molecular services offerings will gain wide acceptance in the market; whether Vilazodone will advance further in the clinical trials process and whether and when, if at all, Vilazodone will receive final approval from the U.S. Food and Drug Administration and equivalent foreign regulatory agencies and for which indications; whether Vilazodone will be successfully marketed if approved; the extent to which genetic markers (haplotypes) are predictive of clinical outcomes and drug efficacy and safety; the strength of our intellectual property rights; competition from pharmaceutical, biotechnology and diagnostics companies; the development of and our ability to take advantage of the market for pharmacogenetic and biomarker products and services; general economic downturns; and other risks contained in our various SEC reports and filings, including but not limited to our Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the fiscal year ended March 31, 2007, our Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the fiscal quarter ended June 30, 2007, and our Current Reports on Form 8-K Form 8-K The form required by the SEC when a publicly held company incurs any event that might affect its financial situation or the share value of its stock. Form 8-K See 8-K. filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events. [TABLE OMITTED] [TABLE OMITTED] |
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