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.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV