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Nile Therapeutics Reports 2011 Third Quarter Financial Results

November 14, 2011

SAN MATEO, Calif., Nov. 14, 2011 /PRNewswire/ — Nile Therapeutics, Inc. (OTCQB: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced its third quarter financial results for 2011.

Financial Results

For third quarter of 2011, Nile reported research and development collaboration income relating to its cenderitide program of approximately $0.8 million, as compared to none in the third quarter of 2010. The net loss for the third quarter of 2011 was approximately $1.1 million, or $0.03 per share, compared to a net loss of approximately $1.8 million, or $0.05 per share, during the third quarter of 2010. Weighted-average shares outstanding for the third quarter of 2011 were 39.7 million.

Net cash used in operating activities in the third quarter of 2011 was approximately $0.7 million. As of September 30, 2011, Nile had cash and cash equivalents of approximately $2.6 million compared to approximately $3.4 million as of December 31, 2010.

Update on Cenderitide

In October 2011, Nile completed patient dosing of an open-label Phase I clinical trial evaluating pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of subcutaneous bolus and subcutaneous infusion of cenderitide in patients with chronic heart failure. The trial was an important step towards developing cenderitide as a 90-day outpatient treatment for heart failure patients following admission for acutely decompensated heart failure (ADHF), referred to as the “post-acute” treatment period.

The Phase I clinical trial was designed to evaluate the required dosage to achieve pre-determined plasma levels of cenderitide when delivered through a subcutaneous infusion pump. In Part A of the trial, 12 patients received two subcutaneous bolus injections of cenderitide. In Part B of the trial, 34 patients received a 24-hour continuous subcutaneous infusion of either of two fixed doses of cenderitide or placebo. In Part C, 12 patients received a 24-hour continuous subcutaneous infusion of either a weight-based dose of cenderitide, or placebo. All infusions were delivered through Medtronic, Inc.’s subcutaneous pump technology. Nile plans to announce top-line data from the clinical trial in November 2011, and intends to present the complete data at an upcoming scientific conference.

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. ADHF is the 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 $35 billion. Within 90 days following admission for ADHF, approximately 40% of patients return to the hospital. Nile believes that a decrease in the ADHF re-hospitalization rate, which is the clinical target of the cenderitide development program, could both improve the quality of life for patients and decrease the annual inpatient cost of heart failure.

About Nile Therapeutics

Nile Therapeutics, Inc. is a biopharmaceutical company that develops innovative products for the treatment of cardiovascular disease and other areas of unmet medical needs. Nile is focusing its efforts on developing its lead compound, cenderitide, a novel rationally designed chimeric peptide in clinical studies for the treatment of heart failure. The cenderitide program was granted Fast Track status by the United States Food and Drug Administration. 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, Nile’s plans for further development of cenderitide, Nile’s ability to obtain FDA approval of cenderitide in the post-acute setting and Nile’s beliefs about the potential impact of a decrease of the ADHF re-hospitalization rate on the quality of life for patients, 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 obtain additional capital to fund its product development programs to completion, Nile’s reliance on third-party researchers to develop its product candidates, the final results of the Phase I trial of cenderitide may not support Nile’s preliminary findings, 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.


                           NILE THERAPEUTICS, INC.
                        (A DEVELOPMENT STAGE COMPANY)
                      CONDENSED STATEMENTS OF OPERATIONS
                                 (unaudited)

                               Three Months Ended                     Nine Months Ended
                                       September 30,                          September 30,
                              -------------------                    ------------------

                               2011              2010               2011              2010
                               ----              ----               ----              ----
    Income
       Collaboration
       income            $813,000                $-         $1,159,000                $-
                         --------               ---         ----------               ---

     Operating
     expenses:
       Research
       and
       development      1,470,091         1,148,641          2,795,354         3,517,822
       General
       and
       administrative     499,273           664,095          1,597,855         1,732,745
                          -------           -------          ---------         ---------

       Total
       operating
       expenses         1,969,364         1,812,736          4,393,209         5,250,567
                        ---------         ---------          ---------         ---------

       Loss
       from
       operations      (1,156,364)       (1,812,736)        (3,234,209)       (5,250,567)

     Other
     income
     (expense):
       Interest
       income               1,880             5,954              4,912            17,526
       Interest
       expense                  -                 -                  -                 -
       Other
       income
       (expense)           10,411            (2,711)             8,901            (2,793)
                           ------            ------              -----            ------

       Total
       other
       income
       (expense)           12,291             3,243             13,813            14,733
                           ------             -----             ------            ------

    Net loss          $(1,144,073)      $(1,809,493)       $(3,220,396)      $(5,235,834)
                      ===========       ===========        ===========       ===========

     Basic
     and
     diluted
     loss
     per
     share                 $(0.03)        $(0.05)        $(0.09)        $(0.17)
                           ======            ======             ======            ======

     Weighted-
     average
     common
     shares
     outstanding       39,707,764     34,563,073     36,526,346     31,338,963
                       ==========        ==========         ==========        ==========


                                NILE THERAPEUTICS, INC.
                             (A DEVELOPMENT STAGE COMPANY)
                                CONDENSED BALANCE SHEETS

                                                   September 30,   December 31,
                                                        2011            2010
                                                    (unaudited)
                                                    -----------
    ASSETS
     Current assets
        Cash and cash
         equivalents                                   $2,607,336     $3,378,155
        Prepaid
         expenses and
         other current
         assets                                           420,653        219,095
                                                          -------        -------

                   Total current
                    assets                              3,027,989      3,597,250

     Property and
      equipment,
      net                                                  10,886         16,765
     Other
      noncurrent
      assets                                               51,938         51,938
                                                           ------         ------

                          Total assets                 $3,090,813     $3,665,953
                                                       ==========     ==========

     LIABILITIES AND STOCKHOLDERS'
      EQUITY
     Current liabilities
        Accounts
         payable                                         $504,333       $332,380
        Accrued
         expenses and
         other current
         liabilities                                      177,317        652,275
        Due to related
         party                                             36,167         84,430
                                                           ------         ------

                    Total current
                     liabilities                          717,817      1,069,085
                                                          -------      ---------

                       Total
                        stockholders'
                        equity                          2,372,996      2,596,868
                                                        ---------      ---------

                                  Total
                                   liabilities
                                   and
                                   stockholders'
                                   equity              $3,090,813 $3,665,953
                                                       ==========     ==========

SOURCE Nile Therapeutics, Inc.


Source: PR Newswire