Less than two months after raising $20 million privately, GTx Inc. filed for an initial public offering Wednesday with hopes to raise as much as $86.25 million.
The company applied for a listing on Nasdaq under the symbol "GTXI." Goldman, Sachs & Co., of New York, is serving as lead underwriter. SG Cowen Securities Corp. and Lazard Freres & Co. LLC, both of New York, are acting as co-managers.
The company has not specified the number of shares to be offered or the expected price range. A GTx spokeswoman said the company could not comment due to an SEC-imposed quiet period.
GTx would use the net proceeds to fund its clinical trials and other research and development activities, as well as to fund general corporate purposes.
The company focuses primarily on the treatment of serious men's health conditions. It is studying small molecules that selectively modulate the effects of estrogens and androgens, and it has two products in clinical trials.
The first, Acapodene, is in a Phase IIb trial for the reduction in the incidence of prostate cancer in men with precancerous prostate lesions. The company has enrolled 515 patients in the trial, and an interim analysis of the first 120 patients showed more of a reduction in prostate cancer incidence in patients who received Acapodene compared to those who received placebo. Final results of the trial are expected in the third quarter of 2004. The company is planning a pivotal Phase III trial of Acapodene to treat serious side effects of advanced prostate cancer therapy.
GTx, of Memphis, Tenn., also has completed two Phase II trials of Acapodene in osteoporosis and hot flashes. In one of the trials, patients who received Acapodene at the highest-tested dose experienced a 3.5 percent average increase in lumbar vertebral spine bone mineral density, compared to a 0.5 percent decrease in placebo patients. Also, only 12 percent of treated patients compared to 50 percent of placebo patients experienced an increase in the frequency of hot flashes. GTx expects to begin a Phase III trial for that indication in November in patients who have been receiving androgen deprivation therapy for more than 12 months.
The company's second clinical product, Andarine, is being studied to treat cachexia from various cancer types, an indication for which there are no FDA-approved drugs. GTx has completed three Phase I trials of Andarine. The company plans to begin a Phase II dose-finding trial to treat cachexia from non-small-cell lung cancer in the first half of 2004.
Andarine also might have the potential to treat testosterone deficiency in aging men, or andropause, as well as osteoporosis, the company said in its prospectus.
GTx plans to build its own sales force in the U.S. for those two products, but to seek collaborators to commercialize the products elsewhere.
In the preclinical stage, GTx is studying Prostarine to treat benign prostatic hyperplasia, Ostarine to treat osteoporosis and andropause, and Andromustine to treat prostate cancer that is not responsive to androgen deprivation therapy.
As of June 30, the company had cash and cash equivalents of $3.1 million, or $23.1 million in pro-forma figures. In August, it raised $20 million through current shareholders. (See BioWorld Today, Aug. 21, 2003.)
Principal stockholders include the company's executive officers and directors who own 85.2 percent of the company. Entities associated with Oracle Partners LP, of Greenwich, Conn., own 13.4 percent.