Nile Therapeutics, Inc. Reports 2010 First Quarter Financial Results

SAN MATEO, Calif., May 14 /PRNewswire-FirstCall/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX), a company focused on the development of novel therapeutics for heart failure patients, today announced its first quarter financial results for 2010.

Financial Results

For the three months ended March 31, 2010, Nile reported a net loss of approximately $1.9 million, or $0.07 per share, compared to a net loss of approximately $1.8 million, or $0.07 per share, during the first quarter of 2009. Weighted-average shares outstanding for the quarter were 27.1 million.

Net cash used in operating activities in the first quarter of 2010 was $1.2 million. As of March 31, 2010, Nile had cash and cash equivalents of approximately $2.0 million compared to approximately $3.2 million as of December 31, 2009.

As previously announced, following the completion of the quarter ended March 31, 2010, Nile completed an underwritten public offering of 7,475,000 units of its securities resulting in total net proceeds of $4.5 million after deducting underwriting discounts and offering expenses. Each unit consisted of one share of common stock and 0.30 warrants to purchase common stock.

Update on CD-NP

Nile is currently enrolling a placebo-controlled Phase II study of CD-NP in patients with acute decompensated heart failure in the United States, Germany and Israel. Nile has reached the maximum tolerated dose and identified two doses that appear to have an attractive safety and activity profile in this population of acute heart failure patients. As of May 13, 2010, Nile had dosed 60 of approximately 75 patients anticipated for inclusion in the Phase II study. Top line data is expected by the end of the third quarter, with full data expected by the end of the year.

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, CD-NP, 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 the timing, progress and anticipated results of the clinical development, regulatory processes, clinical trial timelines, expected patient enrollment, anticipated benefits of CD-NP, 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, 2009 filed with the Securities and Exchange Commission on March 3, 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.