Zonagen sees net loss double in 2005, gets OK to begin phase 2 endometriosis study of Proellex

By Angela McDaniels

Seattle, March 13 - Zonagen, Inc.'s net loss for the year ended Dec. 31 doubled to $7.4 million, or $0.77 per share, from $3.7 million, or $0.72 per share, for 2004, according to a company news release.

Net loss for the three months ended Dec. 31 nearly tripled to $2.3 million, or $0.22 per share, from $744,000, or $0.15 per share, for the same period of 2004.

Zonagen attributed the larger net loss for both periods to an increase in clinical research relating to its two products, Androxal and Proellex.

Total revenue for 2005 increased to $634,000 from $257,000 in 2004. For the fourth quarter of 2005, revenue increased to $174,000 from $28,000.

Research and development grants decreased to $4,000 in 2005 from $118,000 in 2004 due to a decrease in the company's Small Business Innovative Research grants. This was offset by an increase in interest income to $630,000 for 2005 from $104,000 for 2004 due to an increase in interest rates and an increase in marketable securities after the company's follow-on public offering on Feb. 1, 2005, according to the release.

As of Dec. 31, Zonagen had cash, cash equivalents and marketable securities of roughly $16.8 million, up from roughly $5.5 million at Dec. 31, 2004.

Zonagen also announced that it received approval to begin its phase 2 study of Proellex for the treatment of endometriosis. The European phase 2 study will enroll 40 women and compare three doses of double-blinded Proellex against open-label Lupron, the current standard of care, for up to six months of treatment, according to the release.

The company said it will likely have reportable interim three-month results from the study in the fourth quarter of this year.

Proellex is also being studied in a U.S. phase 2 trial for the treatment of uterine fibroids, which will enroll 150 patients and compare two doses of Proellex to a placebo in a double-blind design. Data from this trial is not expected until late in the third quarter, the company said.

Zonagen is a clinical-stage biopharmaceutical company based in The Woodlands, Texas, engaged in the development of new drugs to treat hormonal and reproductive system disorders.

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