Nile Therapeutics, Inc. Reports 2010 Fourth Quarter and Full Year Financial Results

SAN FRANCISCO, March 14, 2011 /PRNewswire/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced its fourth quarter and full year financial results for 2010. The company will host a conference call and live webcast to discuss these financial results and provide an update on each of its development programs at 4:30 p.m. EDT on March 15, 2011. Interested investors may participate in the conference call by dialing +1-877-303-1595 (USA) or +1-970-315-0449 (international). Participants may also access both the live and archived webcast of the conference call from the homepage and the investor relations section of Nile’s website at www.nilethera.com.

Financial Results

For the fourth quarter of 2010, Nile reported a net operating loss of $0.8 million, or $0.02 per share. For the full year, net operating loss was $6.0 million, or $0.19 per share. Weighted-average shares outstanding for the quarter and the year ended December 31, 2010 were 34.6 million and 32.2 million, respectively. Nile reported no revenue during the quarter and the year ended December 31, 2010.

As of December 31, 2010, Nile had cash and cash equivalents of $3.4 million compared to $3.2 million as of December 31, 2009. Cash used in operations during the year ended December 31, 2010 was $4.3 million. Nile raised $4.5 million in 2010 through a public offering of common stock and warrants and through the exercise of stock options and warrants.

Update on cenderitide program

In 2010, Nile completed a Phase 2 study of cenderitide (formerly CD-NP), its lead product candidate, in 77 patients with acute decompensated heart failure (ADHF) and mild to moderate renal insufficiency. Data will be presented at the American College of Cardiology Scientific Sessions in early April.

Nile recently announced plans to develop cenderitide as an outpatient therapy to be delivered to ADHF patients continuously for up to 90 days after discharge from the hospital. The first 90 days following admission to the hospital is a critical time for heart failure patients who are known to have combined rates of re-admission and mortality as high as 50% during that period. Nile believes that the cardiac unloading and renal preserving properties of cenderitide could have a significant benefit to patients during a critical time in their recovery from acute heart failure. This is a novel therapeutic space for natriuretic peptides that has been termed “post-acute.” Nile also recently announced plans to collaborate with Medtronic, Inc., which will fund and provide its drug-device expertise as Nile executes on its Phase 1 clinical trial. In the trial, cenderitide will be delivered through Medtronic diabetes pump technology.

As a first step in the post-acute development program, Nile plans to file a new Investigational New Drug (IND) application and to initiate a Phase I pharmacokinetics and pharmacodynamics (PK/PD) clinical trial. Following the Phase 1 study, Nile intends to initiate a larger Phase 2 double-blind, placebo-controlled, dose ranging study in patients admitted to the hospital for acute heart failure. The planned Phase 2 study will evaluate the endpoints of cardiac remodeling, renal function, re-hospitalization and mortality in patients following 90 days of continuous therapy via subcutaneous pump.

About Nile Therapeutics

Nile Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical needs. Nile is initially focusing its efforts on developing its lead compound, cenderitide, a novel rationally designed chimeric peptide in clinical studies for the treatment of heart failure, and CU-NP, a novel rationally designed natriuretic peptide. More information on Nile can be found at http://www.nilethera.com.

Safe Harbor Paragraph for Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Nile’s plans to develop cenderitide in the post-acute setting, the anticipated benefits of cenderitide for patients in the post-acute setting, and Nile’s plans to initiate clinical trials in the post-acute setting, are forward-looking statements. Forward-looking statements also include statements regarding the timing, progress and anticipated results of the clinical development, regulatory processes, clinical trial timelines, expected patient enrollment, anticipated benefits of cenderitide, Nile’s strategy, future operations, outlook, milestones, the timing and success of Nile’s product development, future financial position, future financial results, plans and objectives of management are forward-looking statements. Nile may not actually achieve these plans, intentions or expectations and Nile cautions investors not to place undue reliance on Nile’s forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements Nile makes. Various important factors that could cause actual results or events to differ materially from the forward-looking statements that Nile makes include Nile’s need to raise additional capital to fund its product development programs to completion, Nile’s reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in greater detail in the reports Nile files with Securities and Exchange Commission, including those described under the caption “Risk Factors” in Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2010 filed with the Securities and Exchange Commission on March 14, 2010. Nile is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

SOURCE Nile Therapeutics, Inc.