GTx reports net income of $44.3M for first-quarter 2010 compared with net loss of $11.3M in 2009

GTx, Inc. (Nasdaq: GTXI) today reported financial results for the first quarter of 2010. The net income for the first quarter ended March 31, 2010 was $44.3 million compared with a net loss of $11.3 million for the same period in 2009. Net income for the current period included the recognition of approximately $54.9 million in collaboration revenue due to the termination of our license and collaboration agreement with Merck & Co., Inc in March 2010.

“GTx made good progress in the first quarter across all clinical programs”

"GTx made good progress in the first quarter across all clinical programs," said Mitchell S. Steiner, CEO of GTx. "We secured financing for the second toremifene 80 mg Phase III clinical trial through the expansion of our partnership with Ipsen. The last patient completed the toremifene 20 mg Phase III high grade PIN clinical trial, and we are on track to receive data from the study this summer. Reacquiring full rights to our SARM program will allow GTx to move ostarine forward into late stage studies for cancer cachexia and to explore new partnership opportunities. Finally, we initiated a Phase II clinical trial for GTx-758, a novel oral LH inhibitor for first line treatment of advanced prostate cancer, and we expect results later this summer."

Clinical Development and Product Candidate Pipeline Updates

• Toremifene 80 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy (ADT): GTx has submitted to the United States Food and Drug Administration (FDA) a proposed protocol for the Phase III TREAT 2 (Toremifene for Reduction of fractures and other Estrogen deficiency side effects in men on Androgen deprivation Therapy) clinical trial. GTx expects to initiate the TREAT 2 clinical trial this year after receiving feedback from FDA.
• Toremifene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN): The last patient completed the toremifene 20 mg Phase III high grade PIN clinical trial in February. GTx expects to receive data from the study and to announce results of the trial in the summer of 2010.
• Ostarine™ and other selective androgen receptor modulators (SARMs): GTx is planning to request a meeting with FDA in May to discuss the late stage clinical development of ostarine for the treatment of cancer cachexia.
• GTx-758, an oral luteinizing hormone (LH) inhibitor for the first line treatment of advanced prostate cancer: GTx initiated a Phase II clinical trial evaluating GTx-758 in February and anticipates receiving results from the study in the third quarter.

First quarter 2010 financial highlights

The net income for the quarter ended March 31, 2010 was $44.3 million compared with a net loss of $11.3 million for the same period in 2009.

Revenue for the first quarter of 2010 was $56.6 million compared to $3.6 million for the same period in 2009. Revenues included net sales of FARESTON^® (toremifene citrate) 60 mg, marketed for the treatment of metastatic breast cancer in postmenopausal women and collaboration revenue from our collaborations with Ipsen Biopharm Limited and Merck & Co., Inc. Net sales of FARESTON^® were $799,000 and $759,000 for the three months ended March 31, 2010 and 2009, respectively. Collaboration revenue was $55.8 million and $2.9 million for the first quarter of 2010 and 2009, respectively. Collaboration revenue for the first quarter of 2010 included the recognition of approximately $54.9 million as a result of the termination of our license and collaboration agreement with Merck in March 2010. Additionally, collaboration revenue in the current quarter included approximately $922,000 from the amortization of deferred revenue from Ipsen. Collaboration revenue for the first quarter of 2009 consisted of approximately $1.5 million and approximately $1.4 million from the amortization of deferred revenue from Ipsen and Merck, respectively.

For the three months ended March 31, 2010 and 2009, research and development expenses were $7.7 million and $8.3 million, respectively. General and administrative expenses decreased during the three months ended March 31, 2010 to $4.5 million from $6.5 million for the three months ended March 31, 2009.

At March 31, 2010 GTx had cash, cash equivalents and short-term investments of $38.7 million.