Gtx, Inc. reports Q2 2009 results

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Reviewed

Aug 10 2009

GTx, Inc. (Nasdaq: GTXI) today reported financial results for the second quarter of 2009. The net loss for the second quarter and six months ended June 30, 2009 was $11.3 million and $22.6 million, respectively, compared with a net loss of $13.2 million and $26.0 million for the same periods in 2008. At June 30, 2009 GTx had cash, cash equivalents and short-term investments of $68.9 million.

“We are pleased with the progress of our clinical development programs,” said Mitchell S. Steiner, M.D., CEO of GTx. “Our commercial plans are on track and we are looking forward to launching toremifene 80 mg for patients on ADT, once approved.”

Corporate Updates

Toremifene 80 mg to reduce the risk of fractures in men with prostate cancer on androgen deprivation therapy:
GTx is working closely with the United States Food and Drug Administration as they review the New Drug Application for toremifene 80 mg to reduce the risk of fractures in men with prostate cancer on androgen deprivation therapy. The agency has targeted a Prescription Drug User Fee Act (PDUFA) agency action date of October 30, 2009. Commercial plans are on track to launch toremifene 80 mg following approval by the FDA.

Phase III clinical trial evaluating toremifene 20 mg for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia (PIN):
Following our review of results of recent clinical trials evaluating other potential treatments for the prevention of prostate cancer in low risk and medium risk patients, GTx believes that full three year efficacy and safety data can further differentiate toremifene 20 mg, which is being evaluated in high risk men. GTx has therefore decided not to conduct the event-based efficacy analysis which had been anticipated for late summer of 2009 with results to have been available in the fourth quarter. We will instead, following the conclusion of the study in the first quarter of 2010, conduct the final analyses of the clinical trial. GTx plans to announce results of the study and, if successful, the company’s plans to submit a New Drug Application in 2010.

The GTx and Merck & Co., Inc. collaboration for the discovery, development and commercialization of oral selective androgen receptor modulators (SARMs):
The GTx and Merck SARM collaboration is planning to advance in the following indications in 2009 and 2010: chronic sarcopenia and muscle loss in patients with chronic obstructive pulmonary disease (COPD). GTx and Merck are finalizing plans to evaluate Ostarine™ (designated by Merck as MK-2866) for the treatment of chronic sarcopenia with the goal of initiating a Phase IIb clinical trial in 2010. GTx and Merck have selected muscle loss in patients with COPD as an additional indication for Ostarine clinical development with a goal of initiating a Phase II clinical trial in the first quarter of 2010. GTx and Merck are evaluating additional indications for SARM clinical development.

GTx-758, an oral luteinizing hormone inhibitor for first line treatment of advanced prostate cancer:
GTx expects results from the ongoing Phase I multiple ascending dose clinical trial of GTx-758 in the fourth quarter of 2009. In the second quarter of 2009, GTx completed a Phase I single ascending dose clinical trial evaluating GTx-758 in healthy male volunteers. GTx-758 was well tolerated. The company has initiated a Phase I multiple ascending dose clinical trial evaluating GTx-758 in healthy male volunteers in which it expects to establish the proof of concept of the ability of GTx-758 to reduce testosterone blood concentrations to castrate levels. GTx expects to conclude this trial in the fourth quarter of 2009 and to initiate a Phase II clinical trial in 2010.

Second quarter 2009 financial highlights

The net loss for the quarter ended June 30, 2009 was $11.3 million compared with a net loss of $13.2 million for the same period in 2008.

Revenue for the second quarter of 2009 was $3.8 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 $949,000 and $274,000 for the three months ended June 30, 2009 and 2008, respectively. Collaboration revenue was $2.9 million and $2.7 million for the second quarter of 2009 and 2008, respectively.

For the three months ended June 30, 2009 and 2008, research and development expenses were $7.7 million and $10.4 million, respectively. General and administrative expenses increased during the three months ended June 30, 2009 to $6.9 million from $6.4 million for the three months ended June 30, 2008.

At June 30, 2009 GTx had cash, cash equivalents and short-term investments of $68.9 million. GTx has no debt and no warrants.

Conference Call

There will be a conference call today at 9 a.m. Eastern Time to discuss GTx’s second quarter financial results and to provide a company update. To listen to the conference call, please dial: