Lexicon Pharmaceuticals Provides Clinical Pipeline Update and Reports 2009 First Quarter Results
Conference Call and Webcast at
“Our pipeline of novel drug candidates continues to advance in line with our expectations,” said Dr. Arthur T. Sands, president and chief executive officer of Lexicon. “During the quarter, we also restructured our operations to conserve capital and concentrate our resources on advancing the most promising programs in our pipeline.”
- Lexicon completed a drug-drug interaction study of LX2931 with methotrexate in patients with rheumatoid arthritis in
March 2009. Top line results from the trial indicated that LX2931 was well tolerated in combination with methotrexate, and no drug-drug interactions were observed. In addition, Lexicon will present Phase 1 data for LX2931 at the European League Against Rheumatism (EULAR) annual meeting on June 13, 2009.
- Lexicon continues to enroll patients in a Phase 2a clinical trial of its LX1031 drug candidate for non-constipating irritable bowel syndrome (IBS). Enrollment is on track to be completed by year-end. The trial is designed as a double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of LX1031 and its effects on symptoms associated with IBS. In addition, Lexicon will present Phase 1 data for LX1031 at the Digestive Disease Week (DDW) annual meeting on
May 31, 2009.
- Lexicon is advancing its LX1032 drug candidate, which has received Fast Track status from the U.S. Food and Drug Administration (FDA), into a Phase 2a study in patients with carcinoid syndrome. Lexicon has identified the clinical trial sites for this study, and patient enrollment is expected to begin in the second quarter of 2009. In addition, Lexicon will present Phase 1 data for LX1032 at the Digestive Disease Week (DDW) annual meeting on
June 1, 2009.
- Lexicon is completing the initial single ascending-dose portion of a Phase 1 study of its LX4211 drug candidate for diabetes. Lexicon plans to initiate the multiple ascending-dose portion of the study during the second quarter of 2009 to evaluate the safety, tolerability, and pharmacokinetics of LX4211 in healthy volunteers over a seven-day dosing period.
- Lexicon is continuing preclinical studies of LX7101, a new drug candidate for glaucoma, in preparation for the planned filing of an IND application with the FDA. LX7101 is a small molecule compound that may have the potential for treating glaucoma by lowering intraocular pressure through a new mechanism of action that enhances the eye’s fluid outflow facility. Impairment of fluid outflow is thought to be a major contributing factor in the higher incidence of glaucoma that is observed as people age.
Revenues: Lexicon’s revenues for the three months ended
Research and Development Expenses: Research and development expenses for the three months ended
General and Administrative Expenses: General and administrative expenses for the three months ended
Net Loss Attributable to Lexicon Pharmaceuticals, Inc.: Net loss for the three months ended
Cash and Investments: As of
Lexicon Conference Call:
Lexicon management will hold a conference call to discuss its clinical development progress and financial results for the first quarter of 2009 at
Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon currently has five drug candidates in development for autoimmune disease, carcinoid syndrome, diabetes, glaucoma and irritable bowel syndrome, all of which were discovered by Lexicon’s research team. Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs. For additional information about Lexicon and its programs, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s clinical development of LX1031, LX1032, LX2931, LX4211, and LX7101 and the potential therapeutic and commercial potential of LX1031, LX1032, LX2931, LX4211, and LX7101. This press release also contains forward-looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon’s ability to successfully conduct clinical development of LX1031, LX1032, LX2931, LX4211, and LX7101 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Factors Affecting Forward-Looking Statements” and “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended
Lexicon Pharmaceuticals, Inc. Selected Financial Data Consolidated Statements of Operations Data Three Months Ended March 31, (In thousands, except per share data) 2009 2008 (unaudited) Revenues: Collaborative research $3,605 $7,634 Subscription and license fees 563 1,259 Total revenues 4,168 8,893 Operating expenses: Research and development, including stock-based compensation of $829 and $1,127, respectively 22,976 27,802 General and administrative, including stock-based compensation of $613 and $652, respectively 4,762 5,529 Total operating expenses 27,738 33,331 Loss from operations (23,570) (24,438) Gain on long-term investments, net 517 - Interest income 327 2,781 Interest expense (666) (670) Other expense, net (945) (547) Consolidated net loss. (24,337) (22,874) Less: Net loss attributable to noncontrolling interest in Symphony Icon, Inc. 2,777 4,924 Net loss attributable to Lexicon Pharmaceuticals, Inc. $(21,560) $(17,950) Net loss attributable to Lexicon Pharmaceuticals, Inc. per common share, basic and diluted $(0.16) $(0.13) Shares used in computing net loss attributable to Lexicon Pharmaceuticals, Inc. per common share, basic and diluted 137,075 136,795 Consolidated Balance Sheet Data As of As of March 31, December 31, (In thousands) 2009 2008 (unaudited) Cash and investments, including cash and investments held by Symphony Icon, Inc. $145,467 $158,798 Property and equipment, net 63,027 65,087 Goodwill 25,798 25,798 Total assets 244,452 261,508 Deferred revenue 17,321 19,884 Current and long-term debt 44,923 30,492 Noncontrolling interest in Symphony Icon, Inc. 7,470 10,247 Accumulated deficit (508,955) (487,395) Total Lexicon Pharmaceuticals, Inc. stockholders' equity 165,822 185,580
SOURCE Lexicon Pharmaceuticals, Inc.