What a difference a week makes.

Seven days after explaining why the U.S. Food and Drug Administration did not approve its first drug product, Memphis-based GTx Inc. hosted a second conference call Monday when it reported earnings for the third quarter.

The call was largely anticlimactic with Dr. Mitchell “Mitch” Steiner, the company’s chief executive officer, repeating the company’s intentions to meet with FDA officials, and touting other drug therapies in the GTx product pipeline. Only two industry analysts asked questions during the brief conference call.

The company, which remains in the research and development phases for its products, reported a loss of $12.8 million compared to a loss of $11.9 million during the third quarter of 2008. GTx officials had hoped this month to be launching Acapodene for the prevention of bone fractures in men undergoing hormone deprivation drug therapy for prostate cancer, but the FDA told GTx more clinical trials were needed.

Some explaining to do

GTx stock was down a few pennies in mid-morning trading Monday after having taken a beating last week. The stock was at $3.82 a share. On Oct. 29, the day before the FDA’s scheduled action date on Acapodene, it had traded at $10.86 a share.

“We really need to meet with the FDA and understand what their thoughts are,” Steiner said. “Then we’ll have a better understanding of what our strategy will be. Look, this drug is safe and it’s effective. We had a good trial. The drug has been out there for two decades.

“Really, we’re trying to get our arms around the path to approval and whether it can be done immediately, whether it can be done with delay. We just have to better understand where the FDA’s head is at, as they say. Once we know that, we will report back to everybody and provide the very clear next steps forward so we can at least plan.”

GTx executives hope to convince the FDA that its existing data from clinical trials will answer the agency’s questions about Acapodene (toremifene citrate 80 mg).

Red tape

The FDA told GTx in a letter that it wants a second clinical trail to measure the safety and efficacy of the drug. The agency also wants another trial to demonstrate that the bone-loss drug does not have a detrimental effect on the underlying cancer or on patient survival.

The FDA’s action surprised GTx because the drug has been on the market for years for another indication. Toremifene 60 mg, under the brand name Fareston, is prescribed for women with metastatic breast cancer.

GTx is also involved in clinical trials for drugs to prevent prostate cancer in high-risk groups, to prevent muscle loss in cancer patients and to treat advanced prostate cancer. The company is involved in partnerships with Ipsen Developments Limited and Merck & Co.

Although the company continues to lose money, it has no debt and has $55.5 million in cash on hand. That money is largely from the partnerships with the larger pharmaceutical companies. So far this year, GTx has received $8.6 million in collaboration revenue.