Nile Therapeutics, Inc. Reports 2011 Third Quarter Financial Results

SAN MATEO, Calif., Nov. 14, 2011 /PRNewswire/ -- Nile Therapeutics, Inc. (OTCQB: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced its third quarter financial results for 2011.

Financial Results

For third quarter of 2011, Nile reported research and development collaboration income relating to its cenderitide program of approximately $0.8 million, as compared to none in the third quarter of 2010. The net loss for the third quarter of 2011 was approximately $1.1 million, or $0.03 per share, compared to a net loss of approximately $1.8 million, or $0.05 per share, during the third quarter of 2010. Weighted-average shares outstanding for the third quarter of 2011 were 39.7 million.

Net cash used in operating activities in the third quarter of 2011 was approximately $0.7 million. As of September 30, 2011, Nile had cash and cash equivalents of approximately $2.6 million compared to approximately $3.4 million as of December 31, 2010.

Update on Cenderitide

In October 2011, Nile completed patient dosing of an open-label Phase I clinical trial evaluating pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of subcutaneous bolus and subcutaneous infusion of cenderitide in patients with chronic heart failure. The trial was an important step towards developing cenderitide as a 90-day outpatient treatment for heart failure patients following admission for acutely decompensated heart failure (ADHF), referred to as the "post-acute" treatment period.

The Phase I clinical trial was designed to evaluate the required dosage to achieve pre-determined plasma levels of cenderitide when delivered through a subcutaneous infusion pump. In Part A of the trial, 12 patients received two subcutaneous bolus injections of cenderitide. In Part B of the trial, 34 patients received a 24-hour continuous subcutaneous infusion of either of two fixed doses of cenderitide or placebo. In Part C, 12 patients received a 24-hour continuous subcutaneous infusion of either a weight-based dose of cenderitide, or placebo. All infusions were delivered through Medtronic, Inc.'s subcutaneous pump technology. Nile plans to announce top-line data from the clinical trial in November 2011, and intends to present the complete data at an upcoming scientific conference.

About Heart Failure

Heart failure is the fastest-growing clinical cardiac disease in the U.S. according to the American Heart Association, affecting over 5 million Americans. Over 1 million patients in the U.S. each year are hospitalized with ADHF, an acute exacerbation of heart failure. ADHF is the is the most frequent cause of hospital admission in the U.S. for patients older than 65 years, generating annual inpatient costs of more than $35 billion. Within 90 days following admission for ADHF, approximately 40% of patients return to the hospital. Nile believes that a decrease in the ADHF re-hospitalization rate, which is the clinical target of the cenderitide development program, could both improve the quality of life for patients and decrease the annual inpatient cost of heart failure.

About Nile Therapeutics

Nile Therapeutics, Inc. is a biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical needs. Nile is focusing its efforts on developing its lead compound, cenderitide, a novel rationally designed chimeric peptide in clinical studies for the treatment of heart failure. The cenderitide program was granted Fast Track status by the United States Food and Drug Administration. More information on Nile can be found at http://www.nilethera.com.