GTx reports financial results for the third quarter of 2009

GTx, Inc. (Nasdaq: GTXI) today reported financial results for the third quarter of 2009. The net loss for the third quarter and nine months ended September 30, 2009 was $12.8 million and $35.4 million, respectively, compared with a net loss of $11.9 million and $37.9 million for the same periods in 2008. At September 30, 2009 GTx had cash, cash equivalents and short-term investments of $55.5 million.

“Following the FDA's response on the toremifene 80 mg NDA, we are committed to working with the agency to understand the next steps required to bring this drug to patients," said Mitchell S. Steiner, MD, CEO of GTx. “We have this important product as well as a valuable pipeline of first in class drugs addressing large unmet medical needs which are advancing in clinical development."

Clinical Development and Product Candidate Pipeline Updates

• Toremifene 80 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy (ADT): In October 2009, GTx received a Complete Response Letter from the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for toremifene 80 mg to reduce fractures in men with prostate cancer on ADT. GTx has requested a meeting with the FDA to determine the appropriate next steps regarding the NDA.
• Toremifene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia (PIN): The last patient will complete the toremifene 20 mg Phase III high grade PIN clinical trial in the first quarter of 2010. GTx plans to announce results of the clinical trial in 2010.
• The GTx and Merck & Co. Inc. collaboration for the discovery, development and commercialization of selective androgen receptor modulators (SARMs): GTx and Merck are finalizing plans to initiate a Phase II clinical trial evaluating Ostarine™ (designated by Merck as MK-2866) for the treatment of muscle loss in patients with chronic obstructive pulmonary disease in the first quarter of 2010 and to initiate a Phase IIb clinical trial evaluating Ostarine™ for the treatment of chronic sarcopenia in 2010.
• GTx-758, an oral luteinizing hormone (LH) inhibitor for the treatment of advanced prostate cancer: In 2009, GTx evaluated GTx-758 in healthy male volunteers in two Phase I clinical trials, a single ascending dose clinical trial completed in the second quarter and a multiple ascending dose clinical trial completed in October 2009. GTx-758 was well tolerated in both trials. GTx is planning to initiate Phase II clinical development of GTx-758 in 2010.

Third quarter 2009 financial highlights

The net loss for the quarter ended September 30, 2009 was $12.8 million compared with a net loss of $11.9 million for the same period in 2008.

Revenues for the third quarter of 2009 were $3.6 million compared to $3.0 million for the same period in 2008. 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 Developments Limited and Merck & Co., Inc. Net sales of FARESTON^® were $719,000 and $315,000 for the three months ended September 30, 2009 and 2008, respectively. Collaboration revenue was $2.9 million and $2.7 million for the third quarter of 2009 and 2008, respectively.

For the three months ended September 30, 2009 and 2008, research and development expenses were $8.1 million and $9.2 million, respectively. General and administrative expenses increased during the three months ended September 30, 2009 to $8.0 million from $6.1 million for the three months ended September 30, 2008.

At September 30, 2009 GTx had cash, cash equivalents and short-term investments of $55.5 million.