Encysive reports first-quarter net loss increases to near $30 million, says Thelin remains priority this year

By Jennifer Lanning Drey

Eugene, Ore., May 10 - Encysive Pharmaceuticals reported a net loss of just under $30 million, or 51 cents per basic and diluted share, compared to a net loss of $17.4 million or 30 cents per basic or diluted share for the same period last year.

As of March 31, the company had cash, cash equivalents and accrued interest at $100.5 million, compared to $127.9 million at December 31, 2005.

The increased loss in the first quarter was primarily the result of higher costs associated with key executive hires, infrastructure investments in preparation for the commercialization of Thelin, non-stock-based compensation expense of $2.1 million and other selling, general and administrative expenses, according to a company news release.

"Moving forward, Thelin remains our priority," said Bruce D. Given, M.D., president and chief executive officer of Encysive Pharmaceuticals, in a company conference call held on Wednesday.

Encysive is working closely with the Food and Drug Administration to respond to questions and observations included in an approvable letter sent in March by the agency for Thelin, which is under review for the treatment of pulmonary arterial hypertension.

Abroad, Thelin has active regulatory filings in Europe, Australia and Canada, and the review process in each area is advancing as planned, according to Given. By June or July, Encysive expects to have an opinion from the European Medicine Evaluation Agency on the Thelin application, and if positive, Thelin could be launched in limited European countries in the fall.

"Even as we work with FDA in the U.S., we continue to expand our international commercialization scope at a steady pace," said Given, in the conference call.

The company is also working with the FDA to get TBC3711, its selective endothelin receptor antagonist, released from a clinical hold. The hold was placed after an "unusual finding" was found in a single rat following intravenous dosing of the drug, according to Encysive.

Encysive is a Houston-based biopharmaceutical company.

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