GTx third quarter net loss increases to $9.3 million

Nov 4 2011

GTx, Inc. (Nasdaq: GTXI) today reported financial results for the third quarter of 2011. The net loss for the quarter ended September 30, 2011 was $9.3 million compared with a net loss of $8.6 million for the quarter ended September 30, 2010, reflecting increased research and development costs in connection with the Company's Ostarine™ and Capesaris™ clinical development programs.

“We continue to make progress with our clinical development programs”

"We continue to make progress with our clinical development programs," said Dr. Mitchell S. Steiner, CEO of GTx. "We have recently commenced the POWER1 and POWER2 Phase III clinical trials evaluating Ostarine for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer. These studies are designed to demonstrate that Ostarine treatment compared to placebo in patients with non-small cell lung cancer receiving chemotherapy will maintain muscle mass, improve physical function, and possibly even prolong survival."

Dr. Steiner continued: "We are currently evaluating Capesaris for both first line hormonal and second line hormonal treatment of advanced prostate cancer. For first line hormonal therapy, two Phase II clinical trials are in progress to identify the optimal dose to achieve and maintain castrate levels of serum total testosterone in men with advanced prostate cancer. For second line hormonal therapy, we are initiating this quarter a Phase II clinical trial evaluating Capesaris in men with castration resistant prostate cancer."

Clinical Pipeline Updates

Ostarine™ (GTx-024), a selective androgen receptor modulator for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer (NSCLC): GTx has recently commenced two pivotal Phase III Ostarine™ clinical trials, POWER1 and POWER2 (Prevention and Treatment Of Muscle Wasting in CancER). The studies will be conducted at more than 125 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 who are initiating first line chemotherapy will be randomized to placebo or Ostarine™ 3 mg. The studies are evaluating as coprimary 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. Durability of effect is being assessed as a secondary endpoint at five months. GTx expects data from the POWER1 and POWER2 studies in the first quarter of 2013.

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 to achieve and maintain castration (serum total testosterone levels <50 ng/dL) from day 28 through day 364. In June 2011, GTx initiated its Phase II maintenance dose finding clinical trial evaluating Capesaris™ 1000 mg and 2000 mg once a day tablets compared to Lupron Depot^® (leuprolide acetate for depot suspension) in 156 men with advanced prostate cancer. Enrollment of this clinical trial is complete. GTx has also initiated this quarter a Phase II loading dose finding clinical trial evaluating the optimal dose to castrate men by day 28. The two doses of Capesaris™ being tested are 1000 mg twice a day and 1500 mg twice a day in 102 men with advanced prostate cancer. After day 28, castrate patients will continue treatment on one of three once a day doses of Capesaris™, 2000 mg, 1000 mg or 500 mg, until day 360. The Phase II loading dose finding clinical trial and the Phase II maintenance dose finding clinical trial have a combined objective of assessing efficacy and safety data necessary for the design of Phase III clinical trials, including the determination of the optimal dose of Capesaris™ to achieve and maintain castration. Data from the Phase II maintenance dose finding study will also be used to assess differences in estrogen deficiency side effects between Capesaris™ and Lupron Depot^®. GTx expects to release preliminary topline results of the two Phase II Capesaris™ clinical trials together, with the timing of the announcement being subject to patient enrollment in the Phase II loading dose finding clinical trial.

GTx is initiating this quarter a second line hormonal therapy Phase II clinical study evaluating Capesaris™ 1000 mg and 2000 mg once a day tablets in 50 men with castration resistant prostate cancer (CRPC). The objective of the study is to determine the ability of Capesaris™ to reduce serum PSA and the duration of this PSA reduction in men with CRPC who are currently receiving androgen deprivation therapy.

Third quarter 2011 financial highlights

The net loss for the quarter ended September 30, 2011 was $9.3 million compared with a net loss of $8.6 million for the same period in 2010, reflecting increased research and development costs in connection with the Company's Ostarine™ and Capesaris™ clinical development programs.

Revenue for the third quarter of 2011 was $2.0 million compared to $1.3 million for the same period in 2010. Revenue for the third 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 third quarter of 2010 consisted of net sales of FARESTON^® of $960,000 and collaboration revenue of $336,000 from our former collaboration with Ipsen Biopharm Limited.

For the three months ended September 30, 2011 and 2010, research and development expenses were $8.2 million and $5.6 million, respectively. General and administrative expenses for the third quarter of 2011 were $2.9 million compared to $4.1 million for the same period in 2010.

At September 30, 2011, GTx had cash, cash equivalents and short-term investments of $83.0 million.