CombinatoRx Reports Financial Results for the Third Quarter 2006.Clinical Progress Continues to Validate To prove something to be sound or logical. Also to certify conformance to a standard. Contrast with "verify," which means to prove something to be correct. For example, data entry validity checking determines whether the data make sense (numbers fall within a range, numeric data CombinatoRx Technology CAMBRIDGE, Mass. -- CombinatoRx, Incorporated (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 : CRXX), today reported financial results for the third quarter ended September 30, 2006. "Recent clinical progress, including positive CRx-102 rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. data and enrollment completion in the phase 2 rheumatoid arthritis trial for CRx-139, demonstrates significant progress toward the achievement of our stated 2006 development goals and further validates the CombinatoRx technology," commented Alexis Borisy, 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. of CombinatoRx. Third Quarter of 2006 Financial Results (Unaudited): Net Loss For the third quarter of 2006, CombinatoRx reported a net loss of $8.4 million or ($0.29) per share, as compared to a net loss of $9.5 million in the third quarter of 2005. Revenue Total revenue was $3.2 million in the third quarter of 2006, an increase from the $904,000 reported in the third quarter of 2005. The increase is primarily due to the Company's entry into additional research and development collaboration agreements and payments related to these agreements. Research and Development Expenses Research and development expense totaled $8.5 million in the third quarter of 2006 compared to $6.7 million in the third quarter of 2005. The increase in R&D expense is due primarily to costs associated with additional research and development collaborations, an increase in personnel related expenses to support expanded research, clinical and regulatory activities associated with an advancing pipeline of product candidates and facilities related expenses resulting from the Company's move to Cambridge, Massachusetts This article is about the city of Cambridge in Massachusetts. For the English university town, see Cambridge, England. For other places, see Cambridge (disambiguation). Cambridge, Massachusetts is a city in the Greater Boston area of Massachusetts, United States. . General and Administrative Expenses General and administrative expense was $4.5 million in the third quarter of 2006 compared to $2.1 million in the third quarter of 2005. The increase in general and administrative expense is due primarily to personnel related expenses to support operations as a publicly traded company publicly traded company A company whose shares of common stock are held by the public and are available for purchase by investors. The shares of publicly traded firms are bought and sold on the organized exchanges or in the over-the-counter market. as well as the expansion of our commercial development capabilities and increased stock-based compensation expense under SFAS SFAS Statement of Financial Accounting Standards SFAS Special Forces Assessment and Selection SFAS Student Financial Aid Services SFAS Sport Fishing Association of Singapore SFAS Safety Features Actuation System SFAS Statewide Fixed Assets System No. 123R. Cash, Cash Equivalents and Short-Term Investments As of September 30, 2006, CombinatoRx had cash, cash equivalents and short-term investments of $128.6 million compared to $102.4 million on December 31, 2005. The increase in cash, cash equivalents and short-term investments is primarily due to the closing of our March 2006 private offering of common stock in which CombinatoRx raised net cash proceeds of $45.3 million. 2006 Financial Guidance Based on current operating plans, expected timing and cost of clinical trials and other product development programs, CombinatoRx expects its net use of cash in operating activities to be between $32.0 million and $37.0 million in 2006 and to end the year with a net loss in the range of $31.0 million to $36.0 million, consistent with the guidance provided at our January 31, 2006 Analyst Briefing. Third Quarter 2006 and Recent Accomplishments Include:
-- Presented positive phase 2 results for CRx-102 in rheumatoid
arthritis, in which CRx-102 achieved statistical significance on
primary and secondary endpoints; including a 63% ACR 20 response
compared to 30% with control, and a 50% mean reduction in CRP
compared to 19% with control.
-- CRx-102 has now demonstrated positive results in three clinical
settings, including hand osteoarthritis, in which CRx-102
demonstrated a statistically significant reduction in pain and
stiffness as well as improvements in tender and swollen joints.
The modified-release commercial formulation of CRx-102 is
expected to be completed in 2007 and plans are currently
underway to initiate a phase 2b study with CRx-102.
-- Completed accrual in a 210 patient phase 2 trial of CRx-139 in
rheumatoid arthritis. In this study, CRx-139, an oral synergistic
combination drug candidate containing low doses of the steroid
prednisolone and the anti-depressant paroxetine, is being evaluated
in comparison to low dose prednisolone alone. Conclusion of this
14 week study is anticipated in the spring of 2007.
-- Introduced four late preclinical programs, including CRx-191 and
CRx-197 for topical dermatology, CRx-153 for multiple sclerosis,
and CRx-401 for type-2 diabetes, as examples of potential clinical
product candidates for 2007.
Upcoming Events: * CombinatoRx will host an analyst/investor event on Wednesday, January 17, 2007 from 7:30am to 9:30am ET at the Millennium Broadway Hotel in New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of . During this event, which will include presentations and a moderated Q&A panel, members of the CombinatoRx management team will review accomplishments for 2006 and provide guidance and goals for 2007. Formal presentations will begin at 8:00am and interested parties may access a live webcast of the presentations by visiting the CombinatoRx website at www.combinatorx.com. About CRx-102 CRx-102 is an oral synergistic synergistic /syn·er·gis·tic/ (sin?er-jis´tik) 1. acting together. 2. enhancing the effect of another force or agent. syn·er·gis·tic adj. 1. combination drug candidate containing the cardiovascular agent dipyridamole dipyridamole /di·py·rid·a·mole/ (di?pi-rid´ah-mol) a platelet inhibitor and coronary vasodilator used to prevent thromboembolism associated with mechanical heart valves, to treat transient ischemic attacks, and as an adjunct in and an unconventionally low dose of the steroid prednisolone prednisolone /pred·nis·o·lone/ (pred-nis´ah-lon) a synthetic glucocorticoid derived from cortisol, used in the form of the base or the acetate, sodium phosphate, or tebutate ester in replacement therapy for adrenocortical insufficiency, . CRx-102 works through a novel mechanism of action in which dipyridamole selectively amplifies prednisolone's anti-inflammatory and immunomodulatory activities without replicating its side effects Side effects Effects of a proposed project on other parts of the firm. . In phase 2 clinical trials phase 2 clinical trial Phase 2 study. See Phase study. , CRx-102 demonstrated a powerful anti-inflammatory effect and rapid onset of action onset of action Pharmacology The length of time needed for a medicine to become effective. See Therapeutic drug monitoring. in patients with osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. and rheumatoid arthritis and was generally well tolerated. CRx-102 is being developed in a modified-release commercial formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation for the treatment of multiple immuno-inflammatory diseases. About CombinatoRx CombinatoRx, Incorporated (CRXX) is pioneering the new field of synergistic combination pharmaceuticals and has a broad product portfolio in phase 2 clinical development. Going beyond traditional combinations, CombinatoRx creates product candidates with novel mechanisms of action striking at the biological complexities of human disease. The lead programs in the CombinatoRx portfolio are advancing into later stage clinical trials based on the strength of multiple positive phase 2a results. This portfolio is internally generated from the CombinatoRx proprietary drug discovery technology which provides a renewable and previously untapped source of novel drug candidates. The Company was founded in 2000 and is located in Cambridge, Massachusetts. To learn more about CombinatoRx please visit www.combinatorx.com. Forward-Looking Statement forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. This press release contains forward-looking statements within the meaning of 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 concerning CombinatoRx, its financial condition and results of operations, financial guidance for the fiscal year 2006, key milestones for the remainder of 2006, its product candidates and their clinical potential, its plans for clinical and formulation development of its product candidates, its business plans and its drug discovery technology. These forward-looking statements about future expectations, plans and prospects of CombinatoRx involve significant risks, uncertainties and assumptions, including risks related to the unproven unproven Dubious, nonscientific, not proven, quack, questionable, unscientific adjective Relating to that which has not been validated by reproducible experiments or other scientific methods for determining effect or efficacy nature of the CombinatoRx drug discovery technology, the Company's ability to initiate and successfully complete clinical trials of its product candidates, the Company's ability to develop a modified release formulation of CRx-102, assumptions regarding the mechanism of action of our product candidates, potential difficulty and delays in obtaining regulatory approval for the sale and marketing of its product candidates, the Company's ability to obtain additional funding for its research and development and those other risks that can be found in the "Risk Factors" section of the CombinatoRx Annual Report 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. on file with the Securities and Exchange Commission and the other reports that CombinatoRx periodically files with the Securities and Exchange Commission. Actual results may differ materially from those CombinatoRx contemplated by these forward looking statements. CombinatoRx does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release. [TABLE OMITTED] [TABLE OMITTED] (c) 2006 CombinatoRx, Incorporated. All rights reserved. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion