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Nile Therapeutics Reports 2009 First Quarter Financial Results

SAN FRANCISCO, 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 2009.

Update on CD-NP

In March, Nile announced that the US Food and Drug Administration (FDA) had placed all clinical studies relating to its lead product, CD-NP, on clinical hold. In a letter sent to Nile, and in a follow-up teleconference, the FDA requested additional data on Nile's recently completed Phase 2a clinical study and modifications to CD-NP's current Investigator Brochure (IB). Nile submitted a full response to the FDA in April and anticipates a response from the FDA by the end of May.

Following resolution of the FDA's clinical hold, Nile intends to initiate a 30-patient single-blind, placebo-controlled Phase 2 study (CT005) designed to provide additional information on the safety and tolerability of CD-NP when infused for up to 72 hours in patients with acute heart failure and renal function insufficiency. Additionally, CT005 contains several exploratory efficacy endpoints which may provide clinical evidence of the most compelling differentiating part of the CD-NP hypothesis, specifically that CD-NP enhances renal function in the acute heart failure. The dosing of CT005 is expected to be completed by the end of 2009.

Nile has undertaken substantial cost saving measures, including the reduction of headcount, designed to focus available resources toward the CD-NP program and maximize Nile's ability to complete CT005.

Financial Results

For the first quarter of 2009, Nile reported a net loss of approximately $1.8 million, or $0.07 per share, compared to a net loss of approximately $3.1 million, or $0.13 per share, during the first quarter of 2008. Weighted-average shares outstanding for the quarter were 24.1 million.

Net cash used in operating activities in the first quarter of 2009 was $1.9 million. As of March 31, 2009, Nile had cash and cash equivalents of approximately $3.6 million compared to approximately $5.5 million as of December 31, 2008.

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. A key component of the company's strategy is to acquire the global rights to additional compounds to expand its portfolio. More information on Nile can be found at

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, 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, 2008 filed with the Securities and Exchange Commission on March 12, 2009 and amended on April 23, 2009. 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     Three Months Ended
                                  March 31, 2009         March 31, 2008
                                ------------------     ------------------
    Grant income                   $             -        $             -
                                    --------------        ---------------
    Operating expenses:
     Research and development            1,324,603              1,978,184
     General and administrative            462,468              1,198,339
                                    --------------        ---------------
     Total operating expenses            1,787,071              3,176,523
                                    --------------        ---------------
     Loss from operations              (1,787,071)            (3,176,523)

    Other income (expense):
     Interest income                        14,686                149,436
     Interest expense                            -                  (137)
     Other expense                         (6,423)               (31,713)
                                    --------------        ---------------
     Total other income (expense)            8,263                117,586
                                    --------------        ---------------
    Net loss                        $  (1,778,808)        $   (3,058,937)
                                    ==============        ===============
    Basic and diluted loss per
     share                          $       (0.07)        $        (0.13)
                                    ==============        ===============
    Weighted-average common shares
     outstanding                        24,149,405             24,099,716
                                    --------------        ---------------

                             Summary Balance Sheet Data
                                  (in thousands)

                                     March 31, 2009     December 31, 2008

    Cash and cash equivalents        $        3,607     $           5,501
    Total assets                     $        4,263     $           6,435
    Stockholders' equity             $        3,484     $           5,104

SOURCE Nile Therapeutics, Inc.
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