Rigel Announces Third Quarter 2008 Financial Results and Clinical Update
For the third quarter of 2008, Rigel reported a net loss of $37.7 million,or $1.03 per share, compared to a net loss of $18.9 million, or $0.61 pershare, in the third quarter of 2007. Weighted average shares outstanding forthe third quarters of 2008 and 2007 were 36.6 million and 31.0 million,respectively.
There were no contract revenues from collaborations reported in the thirdquarters of 2008 and 2007.
Rigel reported operating expenses of $38.7 million in the third quarter of2008, compared to $20.4 million in the third quarter of 2007. The increase inoperating expenses was primarily due to increases in clinical developmentexpenses and, to a lesser extent, stock-based compensation expense. Theincrease in clinical development expenses was mainly due to the costsassociated with the ongoing Phase 2b clinical trials of R788 in rheumatoidarthritis (TASKi2 and TASKi3). Stock-based compensation expense increased from$2.8 million in the third quarter of 2007 to $6.0 million in the third quarterof 2008, primarily due to the higher valuation of options granted in the firstquarter of 2008.
For the nine months ended September 30, 2008, Rigel reported a net loss of$99.0 million, or $2.76 per share, compared to a net loss of $55.3 million, or$1.96 per share, for the same period last year. Rigel recorded no contractrevenue from collaborations for the first nine months of 2008, compared with$4.6 million for the same period in 2007.
As of September 30, 2008, Rigel had cash, cash equivalents and availablefor sale securities of $160.4 million, compared to $185.0 million as of June30, 2008 and $108.3 million as of December 31, 2007. In February 2008, Rigelcompleted a public offering raising aggregate net proceeds of approximately$127.5 million.
"Data from our Phase 2a clinical trial of R788 in rheumatoid arthritis wasrecently presented by the principal investigator at the plenary session of theAmerican College of Rheumatology," said James M. Gower, chairman and chiefexecutive officer of Rigel. "We continue to be very pleased with the safetyprofile of R788 and expect to release data on the Phase 2b clinical trials inthe second half of 2009," he added.
Rigel expects that R788 for rheumatoid arthritis will continue to be theprimary clinical focus for Rigel. Two Phase 2b clinical trials are ongoing inrheumatoid arthritis, TASKi2 and TASKi3. Rigel expects TASKi2 to completeenrollment by the first quarter of 2009 and to have initial results by latesummer 2009. Rigel also anticipates that initial results on TASKi3 will beavailable by late summer 2009.
Rigel expects to initiate a Phase 2 clinical trial for T-cell lymphomawithin the next several months. The ongoing Phase 2 lymphoma clinical trialis continuing and is focused on diffuse large B-cell, follicular and other B-cell lymphomas, including chronic lymphocytic leukaemia and small lymphocyticlymphoma (CLL/SLL). Rigel plans to present further results from this ongoingclinical trial at the American Society of Hematology (ASH) meeting in December2008.
The exploratory Phase 2a clinical trial in immune thrombocytopenic purpura(ITP) is ongoing and we expect the results to be published in the next coupleof months. Rigel has deferred initiating any further trials in ITP until acollaboration partner for R788 is in place.
Likewise, Rigel has deferred initiating a clinical trial in lupus withR788 until a collaboration partner for R788 is in place. Rigel plans to workwith any future collaboration partner for R788 to jointly evaluate thisindication and decide how to proceed.
Moving forward, Rigel plans to focus on psoriasis and possible topicalapplications with its Jak3 inhibitor, R348, and to do so with a collaborationpartner. Rigel will move forward with another selective Jak3 inhibitorcompound for transplant rejection. Rigel expects to select this new Jak3inhibitor compound by the end of 2008. Rigel will proceed on its own with thiscompound in transplant rejection. Rigel does not plan to start a secondrheumatoid arthritis program at this time so as not to compete with the moreadvanced R788 program in the clinic.
Given the large Phase 3 requirements of the rheumatoid arthritisindication for R788, and that Rigel will share in part of this effort with acorporate partner, the above clinical decisions allow Rigel to focus itsclinical resources primarily on R788 in rheumatoid arthritis while maintainingmomentum on the product pipeline. Initiation of investment in new largeclinical programs will be deferred until corporate partnering is completed.
Conference Call and Webcast Information
Rigel will host a conference call with simultaneous webcast today at5:30 a.m. PST/8:30 a.m. EST to provide a company update. To access the livecall, please dial 800-265-0241 (domestic) or 617-847-8704 (international) 10minutes prior to the start time and use the passcode 39911675. A replay of thecall will be available, in podcast format, at approximately 9:30 a.m. EST onNovember 3, 2008 until November 10, 2008. To access the replay, please dial888-286-8010 (domestic) or 617-801-6888 (international) and use the passcode37653591. The conference call will also be webcast live and can be accessedfrom Rigel's website at http://www.rigel.com. Please connect to Rigel'swebsite several minutes prior to the start of the live webcast to ensureadequate time for any software downloads that may be necessary.
About Rigel (http://www.rigel.com)
Rigel is a clinical-stage drug development company that discovers anddevelops novel, small-molecule drugs for the treatment ofinflammatory/autoimmune diseases and cancer, as well as viral and metabolicdiseases. Our pioneering research focuses on intracellular signaling pathwaysand related targets that are critical to disease mechanisms. Rigel'sproductivity has resulted in strategic collaborations with largepharmaceutical partners to develop and market our product candidates. Rigelhas product development programs in inflammatory/autoimmune diseases such asrheumatoid arthritis, thrombocytopenia and asthma, as well as in cancer.
This press release contains "forward-looking" statements, includingstatements related to relating to the potential efficacy of R788, as well asRigel's plans to pursue clinical development of R788 and other productcandidates, and the timing thereof, the market opportunity for its productcandidates, expansion of and changes in its product portfolio and its plans topursue collaboration partnerships for product candidates. Any statementscontained in this press release that are not statements of historical fact maybe deemed to be forward-looking statements. Words such as "plans,""potential," "intends," "indicates," "promising," "expects," "anticipates" andsimilar expressions are intended to identify these forward-looking statements.There are a number of important factors that could cause Rigel's results todiffer materially from those indicated by these forward-looking statements,including risks associated with the timing and success of clinical trials andthe commercialization of product candidates, potential problems that may arisein the clinical testing and approval process and Rigel's need for additionalcapital, as well as other risks detailed from time to time in Rigel's SECreports, including its Form 10-Q for the quarter ended June 30, 2008. Rigeldoes not undertake any obligation to update forward-looking statements.Contact: Ryan D. Maynard Phone: 650.624.1284 Email: email@example.com STATEMENTS OF OPERATIONS (in thousands, except per share amounts) Three Months Ended Nine Months Ended September 30, September 30, 2008 2007 2008 2007 (unaudited) (unaudited) Revenues: Contract revenues $- $- $- $4,600 Operating expenses: Research and development (see Note A) 31,232 15,372 81,268 48,404 General and administrative (see Note A) 7,450 5,054 21,436 15,466 Total operating expenses 38,682 20,426 102,704 63,870 Loss from operations (38,682) (20,426) (102,704) (59,270) Interest income, net 991 1,482 3,722 4,000 Net loss $(37,691) $(18,944) $(98,982) $(55,270) Net loss per share, basic and diluted $(1.03) $(0.61) $(2.76) $(1.96) Weighted average shares used in computing net loss per share, basic and diluted 36,581 31,030 35,837 28,211 Note A Stock-based compensation expense included in: Research and development $3,035 $1,294 9,229 4,212 General and administrative 3,001 1,500 8,572 4,909 $6,036 $2,794 $17,801 $9,121 SUMMARY BALANCE SHEET DATA (in thousands) September 30, December 31, 2008 2007(1) (unaudited) Cash, cash equivalents and available for sale securities $160,358 $108,296 Total assets 168,577 115,789 Stockholder's equity 130,740 82,182 (1) Derived from audited financial statements
SOURCE Rigel Pharmaceuticals, Inc.
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