GTx, Inc. (Nasdaq: GTXI) today provided a Company update and reported financial results for the fourth quarter and full year 2011.
“We are pleased with the progress of our clinical development program of enobosarm, formerly known as Ostarine™”
"Today, in a separate news release, we announced that following our request to discuss changes in our clinical development program because of dose related safety involving venous thromboembolic events, FDA notified the Company in a telephone call on Friday, February 17 that it was placing a clinical hold on our Phase II clinical studies of Capesaris® for first line treatment of advanced prostate cancer and secondary hormonal therapy," said Mitchell S. Steiner, MD, CEO of GTx. "We believe there may be a path forward to develop Capesaris at lower doses to treat men with metastatic hormone sensitive prostate cancer or castration resistant prostate cancer, and we plan to work with the agency to design appropriate studies for these patient populations."
"We are pleased with the progress of our clinical development program of enobosarm, formerly known as Ostarine™," Dr. Steiner said. "Our discussions with lung cancer thought leaders and patient advocates confirm the need for a drug to prevent and treat muscle wasting in patients with advanced non-small cell lung cancer."
Clinical pipeline updates
• Enobosarm (OstarineTM, GTx-024), an oral selective androgen receptor modulator, for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer: GTx was granted the generic name "enobosarm" for Ostarine as a first in class agent. GTx has recently commenced two pivotal Phase III clinical trials, POWER1 and POWER2 (Prevention and Treatment Of Muscle Wasting in CancER) in patients with advanced non-small cell lung cancer. These clinical trials were designed based on feedback from the United States Food and Drug Administration (FDA). In the fourth quarter, GTx met with representatives of the Medicines and Healthcare Products Regulatory Agency (United Kingdom) and Medical Products Agency (Sweden), who confirmed that the design of the POWER1 and POWER2 clinical trials should be sufficient for the European Medicines Agency to support registration in Europe. These international 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 will be randomized to placebo or enobosarm 3 mg at the time they are to begin first line chemotherapy. The studies are evaluating as co-primary endpoints after three months of treatment the effect of enobosarm versus placebo on maintaining or improving total lean body mass (muscle) assessed by dual x-ray absorptiometry (DXA) and on improvement of physical function assessed by the Stair Climb Test. Durability of the drug effect is being assessed as a secondary endpoint after five months of treatment. GTx expects data from the POWER1 and POWER2 Phase III clinical studies in the first quarter of 2013.
• Capesaris® (GTx-758), an oral selective estrogen receptor alpha agonist, for first and second line hormonal treatment of advanced prostate cancer prior to chemotherapy: GTx announced today that the FDA notified the Company in a telephone call on Friday, February 17, 2012, that the agency has placed a clinical hold on clinical trials evaluating Capesaris (GTx-758) for primary (first line) androgen deprivation therapy for advanced prostate cancer and secondary (second line) hormonal treatment. A clinical hold is a notification issued by the FDA to the trial sponsor to delay a clinical trial or suspend an ongoing clinical trial. The Company plans to work with the FDA to determine the appropriate path forward to evaluate Capesaris for the treatment of men with metastatic hormone sensitive prostate cancer or castration resistant prostate cancer.
Financial highlights for the quarter and year ended December 31, 2011
The net loss for the quarter ended December 31, 2011 was $10.7 million compared to a net loss of $7.5 million for the same period in 2010 reflecting increased research and development costs in connection with the Company's enobosarm and Capesaris clinical development programs. The net loss for the year ended December 31, 2011 was $33.3 million compared to net income of $15.3 million for the year ended December 31, 2010.
Revenue was $1.8 million for both of the quarters ended December 31, 2011 and 2010. Revenue for the fourth quarter of 2011 consisted of net sales of FARESTON® (toremifene citrate) 60 mg, approved for the treatment of metastatic breast cancer in postmenopausal women. Revenue for the fourth quarter of 2010 consisted of net sales of FARESTON® of $1.5 million and collaboration revenue of $336,000 from our former collaboration with Ipsen Biopharm Limited.
Revenue for the year ended December 31, 2011 was $14.7 million compared to revenue of $60.6 million for the year ended December 31, 2010. Revenue for the year ended December 31, 2011 included net sales of FARESTON® of $6.7 million and collaboration revenue from Ipsen of $8.1 million as a result of the termination of our license and collaboration agreement with Ipsen in March 2011. Revenue for the year ended December 31, 2010 consisted of net sales of FARESTON® of $3.8 million, collaboration revenue from Ipsen of $1.9 million, and collaboration revenue from Merck & Co. of $54.9 million resulting from the termination of our license and collaboration agreement with Merck in March 2010.
Research and development expenses for the quarter and year ended December 31, 2011 were $8.9 million and $31.9 million, respectively, compared to $5.8 million and $28.5 million for the same periods in 2010. General and administrative expenses for the quarter and year ended December 31, 2011 were $3.4 million and $15.4 million, respectively, compared to $4.5 million and $17.4 million for the same periods in 2010.
At December 31, 2011, GTx had cash, cash equivalents and short-term investments of $74.4 million.