GTx second-quarter net loss increases to $12.9 million

GTx, Inc. (Nasdaq: GTXI) today reported financial results for the second quarter of 2010. The net loss for the quarter ended June 30, 2010 was $12.9 million compared with a net loss of $11.3 million for the quarter ended June 30, 2009. The net loss for the second quarter of 2010 included a $1.7 million non-cash impairment charge related to the conclusion of the Phase III clinical trial of toremifene 20 mg. For the six months ended June 30, 2010, GTx reported net income of $31.4 million compared with a net loss of $22.6 million for the same period in 2009.

“In the third quarter, we will report topline results of the Phase II clinical trial of GTx-758, which is a selective ER alpha agonist for first line treatment of advanced prostate cancer”

"In the third quarter, we will report topline results of the Phase II clinical trial of GTx-758, which is a selective ER alpha agonist for first line treatment of advanced prostate cancer," said Mitchell S. Steiner, MD, CEO of GTx. "GTx-758 is being developed as an oral agent to reduce serum total testosterone to castrate levels and serum free testosterone to levels lower than orchiectomy or LHRH analogs, without bone loss or hot flashes. If we are able to achieve this potential product profile, GTx-758 would be the first truly differentiated approach to androgen deprivation therapy for prostate cancer within the last three decades."

Clinical Pipeline Updates

• GTx-758, a selective ER alpha agonist for the first line treatment of advanced prostate cancer: GTx has conducted a Phase II clinical trial evaluating GTx-758 in 70 healthy males and expects results from the study in the third quarter of 2010. GTx-758 has the potential to reduce serum total testosterone and serum free testosterone to castrate levels without causing hot flashes or bone loss.
• Ostarine™ for the treatment of cancer cachexia and other muscle wasting diseases: GTx is pursuing a partnership for the development of selective androgen receptor modulators (SARMs), which include ostarine, our lead SARM, for the treatment of cancer cachexia.
• Toremifene 80 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy: GTx has met with the United States Food and Drug Administration and is continuing to work with the agency to finalize the 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 in the first quarter of 2011.

Second quarter 2010 financial highlights

The net loss for the quarter ended June 30, 2010 was $12.9 million, which included a $1.7 million non-cash impairment charge, compared with a net loss of $11.3 million for the same period in 2009.

Revenue for the second quarter of 2010 was $935,000 compared to $3.8 million for the same period in 2009. Revenues for both periods 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 collaboration with Ipsen Biopharm Limited. Revenues for the second quarter of 2009 also included collaboration revenue from our collaboration with Merck & Co., Inc., which was terminated in March 2010. Net sales of FARESTON^® were $599,000 and $949,000 for the three months ended June 30, 2010 and 2009, respectively. Collaboration revenue was $336,000 and $2.9 million for the second quarter of 2010 and 2009, respectively.

For the three months ended June 30, 2010 and 2009, research and development expenses were $9.5 million and $7.7 million, respectively. Research and development expenses for the three months ended June 30, 2010 included a non-cash impairment charge of $1.7 million related to toremifene 20 mg intangible assets. The impairment charge was recorded in connection with the unsuccessful conclusion of the Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia and the Company's current expectation not to conduct additional clinical testing of toremifene 20 mg.

General and administrative expenses decreased during the three months ended June 30, 2010 to $4.3 million from $7.0 million for the three months ended June 30, 2009.

At June 30, 2010, GTx had cash, cash equivalents and short-term investments of $28.4 million.