Nov 2 2006, 6:00 AM EST
News source: Business Wire
GTx, Inc. (NASDAQ: GTXI), the Men's Health Biotech Company, today reported financial results for the third quarter of 2006. The net loss for the third quarter and nine months ended September 30, 2006 was $10.9 million and $30.8 million, respectively, compared with a net loss of $9.9 million and $29.0 million for the same periods in 2005. This performance is consistent with GTx's previously stated financial guidance.
"We are proud of the significant progress GTx made in the third quarter. We achieved a major milestone with the execution of our definitive agreement granting Ipsen exclusive European development and marketing rights of ACAPODENE(R)," said Mitchell S. Steiner, M.D., Chief Executive Officer of GTx. "This partnership allows us to achieve three major corporate objectives. Financially, the partnership's upfront payment yielded GTx sufficient cash to meet our projected operating requirements through the first quarter of 2008, by which time we expect to have received data from our two pivotal Phase III clinical trials. Second, GTx retains exclusive rights to ACAPODENE(R) in the United States, where we intend to market the drug to physicians treating prostate cancer patients. Third, the transaction places European commercialization of ACAPODENE(R) in the hands of the partner most capable of successfully marketing prostate cancer drugs. Ipsen already has a solid prostate cancer franchise in Europe with its lead product, Decapeptyl. ACAPODENE(R) for the treatment of multiple side effects of ADT and ACAPODENE(R) for the prevention of prostate cancer will further strengthen their product portfolio."
"In the current quarter we will receive important data from our proof of concept Phase II clinical trial of ostarine," Steiner said. "The information from this trial we hope will show the potential of SARMs to build muscle and bone in both men and women. We look forward to reporting top line results toward the end of the year."
Revenues for the quarter and nine months ended September 30, 2006 were $1.1 million and $2.9 million, respectively, as compared to $0.6 million and $3.1 million for the third quarter and first nine months of 2005. Revenues in all periods included net sales of FARESTON(R) (toremifene citrate 60 mg), marketed for the treatment of metastatic breast cancer, and collaboration revenue for andarine from our partner, Ortho Biotech Products, LP, a subsidiary of Johnson & Johnson. Revenues for the third quarter of 2006 also included collaboration revenue for the period September 7, 2006 through September 30, 2006 from our partner, Ipsen Group ("Ipsen"), which has acquired from GTx the exclusive rights to develop and market ACAPODENE(R) (toremifene citrate) in the European Union, Commonwealth of Independent States and certain other European countries ("European Territory"). GTx is developing ACAPODENE(R) in two separate indications in men: ACAPODENE(R) 80 mg for the treatment of multiple side effects of androgen deprivation therapy (ADT) for advanced prostate cancer, and ACAPODENE(R) 20 mg for the prevention of prostate cancer in men with the precancerous lesion of the prostate, high grade prostatic intraepithelial neoplasia (PIN).
Research and development expenses for the third quarter and first nine months of 2006 were $9.6 million and $26.5 million, respectively, compared to $8.5 million and $24.4 million for the same periods in 2005. The increase in research and development spending was primarily the result of the Company's continued investment in its clinical programs, including increased spending for the development of ostarine in an ongoing Phase II clinical trial.
General and administrative expenses for the quarter and nine months ended September 30, 2006 were $2.9 million and $8.5 million, respectively, compared to $2.3 million and $7.4 million for the same per
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