GTx Provides Corporate Update and Reports Second Quarter 2012 Financial Results
<0> GTx, Inc.Marc Hanover, President, 901-523-9700 </0>
GTx, Inc. (Nasdaq: GTXI) today provided a Company update and reported financial results for the second quarter of 2012.
“We continue to make progress on our late stage clinical programs. We are enrolling our two pivotal Phase III clinical trials evaluating enobosarm for the prevention and treatment of muscle wasting in non-small cell lung cancer patients,” said Mitchell S. Steiner, MD, CEO of GTx. “We expect to receive topline data from these studies during the second quarter of 2013. In addition, we will begin screening patients this month for our Phase II clinical study of Capesaris as secondary hormonal therapy in men with metastatic castration resistant prostate cancer.”
GTx 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. The studies are evaluating as co-primary endpoints at three months of treatment the response rates of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry and improving physical function assessed by the Stair Climb Test. Durability of the drug effect is being evaluated as a secondary endpoint after five months of treatment. 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 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. The study is expected to provide confirmation of the mechanism of drug action for Capesaris on lowering serum free testosterone levels by increasing serum SHBG in castrated men who failed primary androgen deprivation therapy. The safety and tolerability of lower doses of Capesaris will also be evaluated in these subjects, including the incidence of venous thromboembolic events.
The net loss for the quarter ended June 30, 2012 was $10.4 million compared to a net loss of $10.7 million 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 ended June 30, 2012 were $9.2 million compared to $7.6 million for the same period in 2011. General and administrative expenses for the quarter ended June 30, 2012 were $2.6 million compared to $4.5 million for the same period in 2011.
At June 30, 2012, GTx had cash and short-term investments of $55.9 million.
There will be a conference call today at 9:00 a.m. Eastern Time. To listen to the conference call, please dial 866-356-4281 from the United States or Canada or 617-597-5395 from other international locations. The access code for the call is 90153804. A playback of the call will be available from approximately 11:00 a.m. Eastern Time today through August 22, 2012 and may be accessed by dialing 888-286-8010 from the United States or Canada or 617-801-6888 from other international locations and referencing reservation number 54291257. Additionally, you may access the live and subsequently archived webcast of the conference call from the Investor Relations section of the Company’s website at .
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules for the treatment of cancer, cancer supportive care, and other serious medical conditions.