GTx Posts Quarterly, Yearly Net Loss

By Michael Waddell

Memphis-based biopharmaceutical company GTx Inc. has reported net loss of $10.7 million for the fourth quarter ended Dec. 31 compared to a similar $10.7 million net loss in Q4 2011.

Memphis-based GTx Inc. has reported a net loss of $10.7 million for the fourth quarter.

(Daily News File Photo: Lance Murphey)

The company continues its clinical trials for two new medications used in treatments involving lung and prostate cancer. In January, GTx received fast track designation from the U.S. Food and Drug Administration for enobosarm, a new drug in development for the prevention and treatment of muscle wasting in non-small cell lung cancer.

“The FDA clearly recognizes muscle wasting in cancer patients as a serious and unmet medical need,” said Dr. Mitchell Steiner, GTx chief executive officer.

He believes the new drug will increase a patient’s quality of life while they fight their cancer, potentially better equip them to tolerate chemotherapy treatments for longer periods of time and delay their need for specialized services or hospice care.

The FDA fast track designation should speed up the process for when the drug will be available for widespread use in the U.S.

“Our market research suggests that our peak U.S. sales from enobosarm should be approximately $750 million,” Steiner said.

Two international Phase III clinical trials are now being conducted at 80 clinical sites in the U.S., Europe, Russia and South America. Approximately 325 patients with Stage III or IV non-small cell lung cancer receive oral daily doses of placebo or enobosarm 3 mg at the time they began standard first-line platinum doublet chemotherapy.

Steiner expects the trials to be finished by May, and top-line data should be available by the fall.

“Approximately 1.6 million people worldwide will be diagnosed with lung cancer this year, and the five-year survival rate for this diagnosis remains only approximately 50 percent, not withstanding the introduction of many new cancer treatments,” Steiner said. “About 85 percent of all lung cancers are the non-small cell lung cancer type, making this disease the leading cause of death for both men and women.”

GTx also initiated its fifth Phase II clinical study of Capesaris, a hormonal therapy to treat men with metastatic castration resistant prostate cancer.

The company reported a net loss of $27.1 million for the year ended Dec. 31, which included a gain of $18.8 million from the sale of the rights and certain assets related to Fareston 60 mg tablets, approved for the treatment of metastatic breast cancer in postmenopausal women in the U.S. The company reported a net loss of $33.3 million for the year ended Dec. 31, 2011.

GTx’s research and development expenses for the quarter were $10.1 million, compared to $8.9 million for the same quarter in 2011. For the year, research and development expenses totaled $38.9 million, compared to $31.9 million in 2011. At the close of 2012, GTx had cash and short-term investments of $56.1 million, with no debt.

General and administrative expenses for the quarter and year ended Dec. 31 were $2.9 million and $10.8 million, respectively, compared to $3.1 million and $12 million for the same periods of 2011.