Biodel Reports Fourth Quarter Fiscal Year 2012 Financial Results

DANBURY, Conn., Dec. 18, 2012 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD) today reported financial results for the fourth fiscal quarter ended September 30, 2012.

Highlights of fourth fiscal quarter:

• Initiated Phase 2 clinical trial of BIOD-123, an ultra-rapid-acting formulation of recombinant human insulin (RHI); top line data expected in the third calendar quarter of 2013.
• Initiated Phase 1 clinical trial of BIOD-238 and BIOD-250, two ultra-rapid-acting formulations of an insulin analog; top line data expected in the first calendar quarter of 2013.
• Awarded two NIH grants totaling approximately $1.16MM to develop novel and stable glucagon and concentrated ultra-rapid-acting insulin formulations for use in an artificial pancreas.
• Prioritized liquid glucagon program to develop room temperature presentations.
• Hosted research and development seminar featuring independent diabetes experts describing unmet medical needs and therapeutic developments related to Biodel's ultra-rapid-acting insulin and glucagon programs.

Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "We are pleased to be on track to generate top line Phase 1 data for two ultra-rapid-acting insulin analog-based formulations in the first calendar quarter of 2013 and to generate top line Phase 2 safety and efficacy data for RHI-based BIOD-123 in the third calendar quarter of 2013. We believe that our decision to shift our focus to developing a room temperature glucagon presentation presents the best opportunity to achieve a more competitive product."

Fourth Quarter Financial Results

Biodel reported a net loss for the three months ended September 30, 2012 of $5.9 million, or $0.42 per share, compared to net income of $4.1 million, or $0.43 per share, for the same period in the prior year. The results for the three months ended September 30, 2012 and 2011 included an increase of $0.2 million and a decrease of $8.7 million, respectively, in the fair value of the company's common stock warrant liability.

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