GTx reports revenue of $1.6 million for second quarter 2011

GTx, Inc. (NASDAQ: GTXI) today reported financial results for the second quarter of 2011. The net loss for the quarter ended June 30, 2011 was $10.7 million compared with a net loss of $12.9 million for the quarter ended June 30, 2010.

"The Phase IIb Capesaris Maintenance Dose clinical trial for first line hormonal therapy in men with advanced prostate cancer is enrolling as planned," said Mitchell S. Steiner, MD, CEO of GTx. "We also expect to initiate this year both a Phase II Capesaris Loading Dose clinical trial for first line hormonal therapy in men with advanced prostate cancer and a Phase II Capesaris clinical trial for second line hormonal therapy in men on androgen deprivation therapy with castration resistant prostate cancer."

"During this quarter, we will initiate the POWER1 and POWER2 pivotal Phase III clinical trials evaluating Ostarine for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer," Dr. Steiner continued. "We believe that combining Ostarine with first line chemotherapy will result in increased muscle mass, improved physical function and quality of life, and possibly even prolonged survival."

Clinical Pipeline Updates

• Capesaris™ (GTx-758), a selective ER alpha agonist for first line and second line hormonal treatment of advanced prostate cancer: For first line hormonal therapy, the primary endpoint of Phase III clinical trials required by FDA for approval is maintaining castration (serum total testosterone levels <50 ng/dL) from day 28 through day 364. In June 2011, GTx initiated the Phase IIb maintenance dose clinical trial evaluating Capesaris 1000mg and 2000mg compared to Lupron Depot® (leuprolide acetate for depot suspension) in 156 men with advanced prostate cancer. The objective of the Phase IIb clinical trial is to find the lowest dose capable of maintaining castration and to quantify the differences in estrogen deficiency side effects between Capesaris and Lupron. GTx expects primary efficacy results from this open label study by year end 2011. Also this year, GTx plans to initiate a Phase II loading dose clinical trial evaluating Capesaris 1500mg twice daily and 3000mg once daily in 104 men with advanced prostate cancer (52 subjects per study arm). The objective of this study is to determine the optimal dose of Capesaris to achieve castration in at least 90% of men by day 28. GTx expects data from this study by year end 2011. GTx also plans to initiate a second line hormonal therapy Phase II clinical study evaluating Capesaris in men with castration resistant prostate cancer (CRPC). The objective of this study is to determine the ability of Capesaris to reduce serum PSA in men with CRPC currently receiving androgen deprivation therapy.
• Ostarine™, a selective androgen receptor modulator for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer (NSCLC): In patients with NSCLC, muscle loss is an independent predictor of performance status, tolerability to cancer treatment, progression free survival and overall survival. In the current quarter, GTx will initiate two pivotal Phase III Ostarine clinical trials, POWER1 and POWER2 (Prevention and Treatment Of Muscle Wasting in CancER). In each of the placebo-controlled, double-blind clinical trials, 300 patients with Stage III or IV non-small cell lung cancer initiating first line chemotherapy will be randomized to placebo or Ostarine 3mg. The studies will evaluate as co-primary endpoints the effect of Ostarine versus placebo on total lean body mass (muscle) assessed by dual x-ray absorptiometry (DXA) and on physical function assessed by the Stair Climb Test at three months (each endpoint)

Second quarter 2011 financial highlights

The net loss for the quarter ended June 30, 2011 was $10.7 million compared with a net loss of $12.9 million for the same period in 2010.

Revenue for the second quarter of 2011 was $1.6 million compared to $935,000 for the same period in 2010. Revenue for the second quarter of 2011 consisted of net sales of FARESTON^® (toremifene citrate) 60 mg, marketed for the treatment of metastatic breast cancer in postmenopausal women. Revenue for the second quarter of 2010 consisted of net sales of FARESTON^® of $599,000 and collaboration revenue of $336,000 from our former collaboration with Ipsen Biopharm Limited.

For the three months ended June 30, 2011 and 2010, research and development expenses were $7.6 million and $9.5 million, respectively.

General and administrative expenses for the second quarter of 2011 were $4.5 million compared to $4.3 million for the same period in 2010.

At June 30, 2011, GTx had cash, cash equivalents and short-term investments of $91.0 million. On June 28, 2011, GTx completed an underwritten public offering of common stock raising approximately $49.0 million, net of the underwriting discount and offering expenses.