GTx, Inc. (GTXI) reported fourth quarter 2013 net loss per share of 12 cents, narrower than the Zacks Consensus Estimate of a loss of 13 cents and the year-ago loss of 17 cents per share. Shares gained 6% immediately after fourth quarter results were announced. GTx did not generate any revenues in the fourth quarter of 2013, as in the year-ago quarter.
Research and development expenses increased 39.4% year over year to $6.1 million. General and administrative expenses declined 8.2% year over year to $3.1 million.
Annual Results
GTx reported 2013 loss of 67 cents per share, in line with the Zacks Consensus Estimate but wider than the 2012 loss of 65 cents per share. The company did not record any revenues during the year 2013.
Pipeline Update
The pipeline at GTx includes enobosarm 3 mg, enobosarm 9 mg and Capesaris.
In Aug 2013, enobosarm 3 mg failed to meet overall requirements for the co-primary responder endpoints of lean body mass and physical function as agreed upon with the U.S. Food and Drug Administration (FDA). Results were presented from the placebo controlled, double blind POWER 1 and POWER 2 pivotal phase III clinical studies that were conducted in patients suffering from advanced non-small cell lung cancer (NSCLC).
In a recent meeting with the FDA, the company learned that the current data from the POWER trials are insufficient to support the filing of a new drug application (NDA). GTx plans to meet with the FDA again to sort out the phase III program required for the filing of an NDA.
Following a discussion on the results of the POWER trial with the European Medicines Agency (EMA), GTx expects to submit a marketing authorization application (MAA) by the first quarter of 2015 for enobosarm 3mg.
Another candidate, enobosarm 9mg, is evaluated in a phase II, open-label clinical trial for the treatment of androgen receptor (AR) positive and estrogen receptor (ER) positive metastatic breast cancer. GTx expects to at least demonstrate 3 clinical benefit responses in a minimum of 14 patients with AR positive metastatic breast cancer. Data is expected in the second quarter of 2014.
Capesaris, the third candidate, is currently in a phase II study for secondary hormonal therapy in men with metastatic castration resistant prostate cancer. This study is evaluating the safety and effectiveness of two doses (125 mg and 250 mg oral daily dose) of Capesaris. Enrollment in the 125 mg cohort has been completed while enrolment in the 250 mg arm is in progress.
GTx carries a Zacks Rank #3 (Hold). Investors looking for better-ranked stocks in the biopharma sector may consider companies like Gilead Sciences Inc. (GILD), Shire (SHPG) and Alkermes (ALKS), all of which carry a Zacks Rank #1 (Strong Buy).
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