GTx Inc. (GTXI) provided a Company update and reported financial results for the second quarter of 2012.
The net loss for the second-quarter was $10.4 million or $0.17 per share compared to a net loss of $10.7 million or $0.21 per share for the same period in 2011.
Revenue for both the second quarter of 2012 and 2011 was $1.6 million and consisted of net sales of FARESTON (toremifene citrate) 60 mg, approved for the treatment of metastatic breast cancer in postmenopausal women.
Research and development expenses for the quarter were $9.2 million compared to $7.6 million for the same period in 2011.
Analysts polled by Thomson Reuters expected the company to report a loss of $0.17 per share on revenues of $2.26 million for the quarter. Analysts' estimates typically exclude special items.
GTx said it is currently enrolling subjects with advanced non-small cell lung cancer in two pivotal Phase III clinical trials, POWER 1 and POWER 2. These international Phase III studies are being conducted in clinical sites in the United States, Europe, and South America.
In each of the placebo-controlled, double-blind clinical trials, 300 patients with Stage III or IV non-small cell lung cancer are being randomized to oral daily doses of placebo or enobosarm 3 mg at the time they begin first line standard chemotherapy. Enrollment for both studies is expected to be completed in the fourth quarter of this year, and topline results should be released during the second quarter of 2013.
GTx noted that it is initiating this quarter an open-label clinical study of 75 men with metastatic castration resistant prostate cancer to test three lower doses of Capesaris (125 mg, 250 mg and 500 mg) sequentially in cohorts of 25 patients each. The Phase II 712 clinical trial is designed to assess the effect of Capesaris on serum prostate specific antigen response and prostate cancer progression.
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