Staff Writer

Already seriously low on cash, Repros Therapeutics Inc. has stopped dosing patients in its trials of Proellex after finding significant increases in liver enzymes with 25-mg and 50-mg doses.

As a result, The Woodlands, Texas-based company saw its stock plummet 48 percent as it scrambles for cash and tries to resolve the liver enzyme problem.

CEO Joseph Podolski said that his number one job is "to take care of patients," and he noted that the dose initially was dropped in Proellex trials from 50 mg to 25 mg and that study patients had received exhaustive safety assessments.

Now that dosing has been discontinued, Podolski said that the company is "realistic" in terms of what the situation could mean for Proellex development and for the company's financial outlook. "We just need to be very pragmatic about the way we approach this. . . . We just need to be cautious with our shareholders' assets."

Repros is testing Proellex as a potential treatment for chronic symptomatic uterine fibroids, anemia associated with the condition and endometriosis. Study patients in those ongoing trials were receiving the 25-mg dose. Repros already had switched some patients from the 50-mg dose to 25 mg after elevated liver enzymes were seen at the higher dose.

According to the company's unlocked clinical trial database, as of July 27, about 500 study patients had received Proellex, of which 190 had received a dose of 50 mg per day and 260 were taking the 25-mg dose and 55 received a dose of 12.5 mg. The 12.5 mg dose was studied in an earlier Phase II uterine fibroid study, but no patients were receiving 12.5 mg per day in any trial at the time dosing was discontinued, Repros said.

Repros had planned to have an end-of-Phase II meeting with the FDA in late September about endometriosis, but the agency has proposed changing the topic to the safety of Proellex and overall direction and scope of the program, the company said.

It is also unclear what will become of Repros' other product, Androxal, a drug candidate for male infertility and restoring testicular function in men with diabetes.

The company has not yet reported results from its comparative Phase IIb study (ZA-201) of Androxal vs. Testim 1 percent testosterone gel (Auxilium Pharmaceuticals, Malvern, Pa) for the treatment of men with low testosterone who want to improve or maintain their fertility and sperm number and function.

The FDA has indicated that testosterone can't be used as an endpoint, and it also urged the company to submit a protocol for Androxal in diabetes, Podolski said. But he said diabetes would be a huge study for such a small company.

Brian Abrahams, an analyst with Oppenheimer & Co., stated in a research note, "With the program's future in serious question, the company's limited cash position, and little value for [Repros'] other program Androxal, we believe today's downside is warranted. We expect further clarity on the company's direction over the next few months and remain cautious as to the outlook."

Abrahams estimated that the company's current cash is about $3 million to $4 million now that the Proellex program is suspended. That money, he said, could last around eight weeks.

Shares of Repros (NASDAQ:RPRX) dropped $1.22 per share, closing at $1.31.