SAN DIEGO, Nov. 8, 2011 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the third quarter of 2011. For the three months ended September 30, 2011, Orexigen reported a net loss of $4.6 million, or $0.10 per share, as compared to a net loss of $14.6 million, or $0.31 per share, for the third quarter of 2010. As of September 30, 2011, Orexigen had $33.9 million in cash and cash equivalents and an additional $29.9 million in marketable securities, for a total of approximately $63.8 million.
“Based on feedback provided in written correspondence from the FDA’s Office of New Drugs during the quarter, we were pleased to have identified a very clear and feasible path forward for Contrave®,” stated Mike Narachi, Orexigen President and CEO. “We are now working diligently with our partner Takeda to finalize the details of the protocol with the FDA in order to begin enrollment of the cardiovascular outcomes trial (CVOT) in the first half of 2012.”
Total operating expenses for the third quarter of 2011 were $5.4 million compared to $14.8 million for third quarter of 2010. This decrease in operating expenses primarily reflects a decrease in research and development expenses of $6.6 million principally related to the decrease in license fees, expenses related to our Contrave development program and salaries and personnel related costs. This overall decrease in operating expenses also reflects a decrease in general and administrative costs of $2.7 million principally related to decreases in salaries and personnel related costs, stock-based compensation expense and medical affairs expense.
Last month, the Company also presented new data in several posters at the annual meeting of The Obesity Society in Orlando, FL. Data presentations included:
- Anticipated reduction in predicted 10-year cardiovascular risk among Contrave treated patients from the Phase 3 COR program using a variety of validated risk models.
- An imaging study showing that Contrave activated regions of the brain involved in controlling the response to food cues.
- New analyses from the COR-I and COR-BMOD Phase 3 studies highlighting weight loss among subjects completing one year of therapy.
The Company continues to expect cash expenditures for the second half of 2011 to be substantially lower than for the first half of 2011. The Company does anticipate a substantial increase in planned expenditures in 2012 as the major activities for the CVOT get underway once the details of the protocol are finalized and a clinical research organization to execute the trial is engaged. The Company plans to provide a more detailed update on the specifics of the trial as well as additional financial guidance in the first quarter of 2012.
About Contrave
Contrave, an investigational combination therapy of naltrexone HCl and bupropion HCl, was studied for its ability to help people with obesity initiate and sustain weight loss of at least 5 percent of their starting body weight in one year. Contrave was submitted for U.S. regulatory approval in March 2010. The original submission was based on multiple clinical trials that evaluated Contrave in more than 4500 patients. Orexigen received a Complete Response letter from the FDA on January 31, 2011.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Contrave has completed Phase 3 clinical trials, and the Company’s other product candidate, Empatic(TM), has completed Phase 2 clinical trials. Each of the components of the Company’s product candidates has already received regulatory approval and has been commercialized previously. Further information about the Company can be found at www.orexigen.com.
