Nile third quarter net loss decreases to $1.8 million

Nile Therapeutics, Inc. (Nasdaq: NLTX), a company focused on the development of novel therapeutics for therapeutics for cardiovascular disease, today announced its third quarter financial results for 2010.

Financial Results

For the three months ended September 30, 2010, Nile reported a net loss of approximately $1.8 million, or $0.05 per share, compared to a net loss of approximately $2.0 million, or $0.08 per share, during the third quarter of 2009. Weighted-average shares outstanding for the third quarter were 34.6 million.

Net cash used in operating activities in the third quarter of 2010 was approximately $1.1 million. As of September 30, 2010, Nile had cash and cash equivalents of approximately $4.4 million compared to approximately $3.2 million as of December 31, 2009.

Qualifying Therapeutic Discovery Project Grant

Nile was recently awarded a $244,479 grant under the Internal Revenue Service's Qualifying Therapeutic Discovery Project program, which was established under the U.S. Patient Protection and Affordable Care Act of 2010.  The Company expects to receive the grant funds prior to the end of 2010.

Update on CD-NP

On November 2, Nile announced that CD-NP met the primary end-point, safety and tolerability, in an open-label, single-blind, placebo-controlled Phase 2 study of 77 patients with acute decompensated heart failure (ADHF) and renal dysfunction. Additionally, secondary analyses demonstrated favorable effects of CD-NP on renal function.

An infusion of CD-NP for up to 72 hours at doses of 1.25 and 2.5 ng/kg/min appeared to be well tolerated.  A dose-dependent effect on blood pressure was observed, with minimal or mild blood pressure reduction at 1.25 and 2.5 ng/kg/min, and moderate blood pressure reduction at 3.75 ng/kg/min.  Dose escalation was limited by significant blood pressure reduction at 5 ng/kg/min.  

Secondary and exploratory analyses at doses of 1.25 and 2.5 ng/kg/min demonstrated favorable effects of CD-NP on renal function, as compared to placebo. At these doses, CD-NP appeared to have favorable trends in biomarkers that are correlated with kidney function, including creatinine and cystatin-c. Data will be presented at an upcoming cardiology conference.