DANBURY, Conn., May 9 /PRNewswire-FirstCall/ -- Biodel Inc. (Nasdaq: BIOD) today reported financial results for its second quarter ended March 31, 2008. The net loss for the quarter was $9.6 million or $0.43 per share.
"We remain on track in our development of VIAject(TM)," stated Dr. Solomon Steiner, CEO and Chairman of Biodel. "The last patient visits for both pivotal Phase III clinical trials are scheduled to occur in July. We expect to announce top line data late in the third or early in the fourth calendar quarter of 2008 and to submit our New Drug Application in December. Like all three approved rapid acting insulins, and at the request of the FDA, VIAject(TM)'s pivotal studies are against regular human insulin. We believe VIAject(TM)'s ultra rapid PK/PD profile will produce comparative safety and weight advantages against regular human insulin that have never before been demonstrated by any meal-time insulin. In addition, our market research suggests VIAject(TM)'s existing Phase I and Phase II comparative data against Humalog(R), coupled with successful Phase III data, will lead physicians to prescribe VIAject(TM) to both new patients and patients suffering from frequent hypoglycemic events."
Three Months Ended March 31, 2008
Biodel reported no revenue during the three months ended March 31, 2008 and March 31, 2007.
Biodel reported a net loss for the three months ended March 31, 2008 of $9.6 million, or $0.43 per share, as compared to a net loss applicable to common stockholders of $9.7 million, or $1.79 per share, for the comparable period in the prior year. Net loss for the quarter ended March 31, 2007 included a $4.5 million deemed dividend charge. Net loss for the quarter ended March 31, 2008 includes $1.7 million of stock-based compensation expenses. The stock-based compensation charge includes $0.5 million of stock-based compensation charges for options awarded annually to the board of directors.
Research and de
|SOURCE Biodel Inc.|
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