GTx reports net loss of $2.6 million for first quarter 2011

GTx, Inc. (Nasdaq: GTXI) today provided a company update and reported financial results for the first quarter of 2011.

"We have made strong progress in both the Ostarine and Capesaris clinical development programs," said Mitchell S. Steiner, MD, CEO of GTx. "The indication we will pursue for Ostarine is the prevention and treatment of muscle wasting in patients with non-small cell lung cancer. We expect to initiate two pivotal Phase III clinical trials in the third quarter."

"We are also excited about our Capesaris program. We have met with the FDA and confirmed that the primary endpoint required for approval for Capesaris for first line treatment of advanced prostate cancer will be maintenance of castrate levels of serum total testosterone. We plan to initiate a Phase IIb clinical trial comparing Capesaris to Lupron in advanced prostate cancer patients in the second quarter of 2011. We expect this study to enroll quickly and to have primary efficacy results from this open label study in the fourth quarter of this year," Dr. Steiner said.

Clinical pipeline updates

• Ostarine^TM (GTx-024), a selective androgen receptor modulator, for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer: GTx has held End of Phase II meetings with the U.S. Food and Drug Administration, or FDA, to discuss the proposed Phase III clinical development of Ostarine (GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer. Based upon feedback from the FDA, GTx expects to initiate two pivotal Phase III clinical trials for this indication in the third quarter of 2011. Muscle wasting is a common cancer related symptom that results in the decline in physical function, reduced tolerability and response to chemotherapy, loss of independence, poor cancer outcomes, and reduced survival.

• Capesaris^TM (GTx-758), an oral selective estrogen receptor alpha agonist, for first line treatment of advanced prostate cancer: GTx is planning to initiate in the second quarter of 2011 an open label Phase IIb clinical trial evaluating Capesaris compared to Lupron Depot^® (leuprolide acetate for depot suspension) in men with advanced prostate cancer. GTx expects primary efficacy results of the Phase IIb clinical study, which is the proportion of patients who become castrate by 60 days, to be available in the fourth quarter of 2011. GTx has met with the FDA and confirmed that the primary endpoint for Phase III clinical trials required for approval for first line treatment of advanced prostate cancer is the maintenance of castrate levels of serum testosterone (<50 ng/dL) from Day 28 to Day 364.

• Toremifene 80 mg for the reduction of fractures and treatment of other estrogen deficiency side effects in men with prostate cancer on androgen deprivation therapy: GTx has evaluated the business case for toremifene 80 mg and concluded that the company cannot justify the expense and time required to conduct a second Phase III clinical trial. Accordingly, GTx is discontinuing development of toremifene 80 mg and allocating its resources to the Ostarine and Capesaris programs.

Financial highlights for the quarter ended March 31, 2011

The net loss for the quarter ended March 31, 2011 was $2.6 million compared to a net income of $44.3 million for the same period in 2010.

Revenue for the first quarter 2011 was $9.3 million compared to $56.6 million for the same period in 2010. Revenue for both periods included net sales of FARESTON^® (toremifene citrate) 60 mg, marketed for the treatment of advanced metastatic breast cancer in postmenopausal women and collaboration revenue from Ipsen Biopharm Limited. Net sales of FARESTON were $1.2 million and $799,000 for the three months ended March 31, 2011 and 2010, respectively. Revenue for the first quarter of 2011 included $8.1 million of collaboration revenue as a result of the termination of our license and collaboration agreement with Ipsen during March 2011. Revenue for the first quarter of 2010 included collaboration revenue of $922,000 from Ipsen and the recognition of $54.9 million of revenue due to the termination that quarter of a license and collaboration agreement for our SARM program.

Research and development expenses for the quarter ended March 31, 2011 were $7.3 million compared to $7.7 million for the same period in 2010. Research and development expenses for the three months ended March 31, 2011 included a non-cash impairment charge of $1.6 million related to our toremifene 80 mg intangible asset following the decision to discontinue development of toremifene 80 mg. General and administrative expenses for the quarter were $4.7 million compared to $4.5 million for the same period in 2010.

At March 31, 2011, GTx had cash, cash equivalents and short-term investments of $49.4 million.