Nile Therapeutics Reports 2011 First Quarter Financial Results

May 16, 2011

SAN MATEO, Calif., May 16, 2011 /PRNewswire/ — Nile Therapeutics, Inc. (OTCQB: NLTX), a company focused on the development of novel therapeutics for therapeutics for cardiovascular disease, today announced its first quarter financial results for 2011.

Financial Results

For the three months ended March 31, 2011, Nile reported a net loss of approximately $1.2 million, or $0.03 per share, compared to a net loss of approximately $1.9 million, or $0.07 per share, during the first quarter of 2010. Weighted-average shares outstanding for the first quarter of 2011 were 34.7 million.

Net cash used in operating activities in the first quarter of 2011 was approximately $1.3 million. As of March 31, 2011, Nile had cash and cash equivalents of approximately $2.1 million compared to approximately $3.4 million as of December 31, 2010.

Update on cenderitide

Nile is developing cenderitide as an outpatient therapy to be delivered to acutely decompensated heart failure (ADHF) patients continuously for up to 90 days after discharge from the hospital. The program was recently granted Fast Track status by the United States Food and Drug Administration (FDA).

On May 3, Nile announced dosing of the first patient in a Phase I clinical trial investigating the use of subcutaneous cenderitide. The trial is being conducted in collaboration with Medtronic, Inc. Nile anticipates the completion of enrollment in the Phase I trial in the fourth quarter of 2011.

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. This hospitalization rate is almost double the rate seen 15 years ago, and 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 $33 billion.

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, 2010 filed with the Securities and Exchange Commission on March 14, 2011. 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.

                         Three Months Ended
                                        March 31,            Period from
                                                       August 1, 2005
                                                        through March
                                      2011        2010           31, 2011
                                 ----             ---- --------------

    Grant income                   $-               $-        $482,235
                                  ---              ---        --------

    Operating expenses:
      Research and
       development          622,332        1,313,423      26,481,272
      General and
       administrative       575,278          623,202      14,784,709
                            -------          -------      ----------

      Total operating
       expenses           1,197,610        1,936,625      41,265,981
                          ---------        ---------      ----------

      Loss from
       operations        (1,197,610)      (1,936,625)    (40,783,746)

    Other income
      Interest income         1,986            4,846         789,945
       expense                    -                -      (1,273,734)
      Other (expense)
       income                  (168)             (43)        141,549
                               ----              ---         -------

      Total other
       income (expense)       1,818            4,803        (342,240)
                              -----            -----        --------

    Net loss            $(1,195,792)     $(1,931,822)   $(41,125,986)
                        ===========      ===========    ============

    Basic and diluted
     loss per share          $(0.03)          $(0.07)
                             ======           ======

     common shares
     outstanding         34,673,475       27,085,824
                         ==========       ==========

                            Summary Balance Sheet Data
                                  (in thousands)

                                        March 31, 2011    December 31, 2010
    Cash and cash equivalents                     $2,123              $3,378
    Total assets                                  $2,418              $3,666
    Stockholders' equity                          $1,674              $2,597

SOURCE Nile Therapeutics, Inc.

Source: newswire

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