AEterna Zentaris plans to announce clinical data through end of year, reports $1.6 million Q2 net loss

By Jennifer Lanning Drey

Eugene, Ore., Aug. 11 - AEterna Zentaris, Inc. was pleased with its second quarter results and expects to deliver significant clinical data during the remainder of the year, according to Gilles Gagnon, chief executive officer of AEterna Zentaris.

"With the progress we have made, specifically in this quarter, we will finish 2006 as a late-stage development company and continue to set the stage to emerge as a fully integrated specialty pharmaceutical company with a focus on endocrinology and oncology over the next few years," Gagnon said during a company conference call held Friday.

AEterna Zentaris reported a second quarter net loss of $1.6 million, or $0.03 per basic and diluted share, on revenues of $83.4 million, according to a company news release.

The results compared to net earnings of $13.3 million, or $0.28 per diluted share, on revenues of $60.1 million for the same period in 2005, according to the release.

AEterna Zentaris had cash, cash equivalents and short-term investments of $47.0 million at June 30, compared to $52.7 million at Dec. 31, 2005.

The company expects research and development expenses to increase slightly during the remainder of the year, due to the ongoing phase 2 clinical trial of perifosine and the start of its late-stage clinical program for cetrorelix for treatment of benign prostatic hyperplasia (BPH), said Dennis Turpin, AEterna Zentaris' chief financial officer.

The company plans to complete enrollment in the phase 2 perifosine trial by the end of the year. The trial will test the drug in combination with radiotherapy for treatment of non-small cell lung cancer.

AEterna Zentaris previously announced that interim results from a multi-center phase 2 trial performed by its partner, Keryx Biopharmaceuticals, showed patients with renal cell carcinoma demonstrated a 43% partial response rate when treated with perifosine.

The company is also on track to file an Investigational New Drug Application for its North American phase 3 program for cetrorelix by the end of 2006, Gilles said.

"Our attention to cetrorelix is critical at this time. We are closer than ever to bringing this compound to the market, and we must focus our efforts and resources appropriately as we strongly believe in its potential," Gilles said Friday.

Cetrotide, the company's cetrorelix product for in vitro fertilization, was approved during the second quarter in Japan and will launched by the end of the year, he said.

During the same timeframe, AEterna Zentaris plans to announce results from its phase 2 clinical trial of cetrorelix for BPH being conducted in Japan, he said.

"We are confident that we will continue to deliver positive clinical results throughout the year as we transform into a late-stage company," Gilles said.

Also before the end of the year, AEterna Zentaris plans to announce additional results from a phase 1 clinical trial of AN-152 for gynecological and breast cancers. Initial data from the phase 1 clinical trial demonstrated the compound has a good safety profile and no dose-limiting toxicities reached so far in the selected dose levels.

The company also expects to announce clinical developments of other products currently in preclinical development, he said.

AEterna Zentaris is a biopharmaceutical company based in Quebec City, Quebec.

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