GTx, Inc. (Nasdaq: GTXI) today provides a Company update and reports financial results for the second quarter of 2013.
GTx is evaluating enobosarm (GTx-024) 3 mg, an oral selective androgen receptor modulator, for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer in two pivotal Phase 3 clinical trials. The last patients completed these clinical trials during May 2013. Vital status (survival) of patients participating in the studies will continue to be periodically monitored in accordance with the clinical trial protocols. The Company anticipates providing the topline results for both studies later this quarter which will include the coprimary endpoints, safety assessments, and an update on survival.
GTx continues to enroll the Phase 2, open label clinical trial evaluating enobosarm 9 mg for the treatment of androgen receptor positive and estrogen receptor positive metastatic breast cancer in women who have previously responded to hormonal therapy for the treatment of their advanced breast cancer, which was initiated in the second quarter of 2013. Additionally, GTx continues the enrollment of the Phase 2 clinical trial evaluating Capesaris ® (GTx-758), an oral nonsteroidal selective estrogen receptor alpha agonist, for secondary hormonal therapy in men with castration resistant prostate cancer.Conference call following release of enobosarm phase 3 clinical data In lieu of hosting a financial results conference call today, later this quarter the Company will host a conference call and webcast following its release of topline data from the two pivotal Phase 3 clinical trials for enobosarm 3 mg for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer. Financial highlights for the second quarter of 2013 The net loss for the quarter ended June 30, 2013 was $12.8 million compared to a net loss of $10.4 million for the same period in 2012. The Company’s net loss for the second quarter of 2012 was reduced by net income from discontinued operations of $848,000 related to sales of the commercial product FARESTON ®, the rights for which the Company sold in the third quarter of 2012. Research and development expenses for the quarter ended June 30, 2013 were $10.1 million compared to $9.2 million for the same period of 2012. General and administrative expenses for the quarter ended June 30, 2013 were $2.7 million compared to $2.4 million for the same period of 2012.