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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.