SAN MATEO, Calif., Nov. 12, 2010 /PRNewswire via COMTEX/ -- Nile Therapeutics, Inc. (Nasdaq: NLTX), a company focused on the development of novel therapeutics for therapeutics for cardiovascular disease, today announced its third quarter financial results for 2010.
Financial Results For the three months ended September 30, 2010, Nile reported a net loss of approximately $1.8 million, or $0.05 per share, compared to a net loss of approximately $2.0 million, or $0.08 per share, during the third quarter of 2009. Weighted-average shares outstanding for the third quarter were 34.6 million.
Net cash used in operating activities in the third quarter of 2010 was approximately $1.1 million. As of September 30, 2010, Nile had cash and cash equivalents of approximately $4.4 million compared to approximately $3.2 million as of December 31, 2009.
Qualifying Therapeutic Discovery Project Grant Nile was recently awarded a $244,479 grant under the Internal Revenue Service's Qualifying Therapeutic Discovery Project program, which was established under the U.S. Patient Protection and Affordable Care Act of 2010. The Company expects to receive the grant funds prior to the end of 2010.
Update on CD-NP On November 2, Nile announced that CD-NP met the primary end-point, safety and tolerability, in an open-label, single-blind, placebo-controlled Phase 2 study of 77 patients with acute decompensated heart failure (ADHF) and renal dysfunction. Additionally, secondary analyses demonstrated favorable effects of CD-NP on renal function.
An infusion of CD-NP for up to 72 hours at doses of 1.25 and 2.5 ng/kg/min appeared to be well tolerated. A dose-dependent effect on blood pressure was observed, with minimal or mild blood pressure reduction at 1.25 and 2.5 ng/kg/min, and moderate blood pressure reduction at 3.75 ng/kg/min. Dose escalation was limited by significant blood pressure reduction at 5 ng/kg/min.
Secondary and exploratory analyses at doses of 1.25 and 2.5 ng/kg/min demonstrated favorable effects of CD-NP on renal function, as compared to placebo. At these doses, CD-NP appeared to have favorable trends in biomarkers that are correlated with kidney function, including creatinine and cystatin-c.
Data will be presented at an upcoming cardiology 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. 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, 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.
Condensed Statement of Operations (unaudited) Three months ended September 30, ----------------------------- 2010 2009 ---- ---- Grant income $- $- --- --- Operating expenses: Research and development 1,148,641 1,149,232 General and administrative 664,095 869,143 Total operating expenses 1,812,736 2,018,375 Loss from operations (1,812,736) (2,018,375) Other income (expense): Interest income 5,954 15,194 Interest expense - - Other expense (2,711) (24,499) Total other income (expense) 3,243 (9,305) Net loss $(1,809,493) $(2,027,680) =========== =========== Basic and diluted loss per share $(0.05) $(0.08) ====== ====== Weighted-average common shares outstanding 34,563,073 26,491,211 ========== ========== Nine months ended September 30, ----------------- 2010 2009 ---- ---- Grant income $- $- --- --- Operating expenses: Research and development 3,517,822 3,577,264 General and administrative 1,732,745 2,729,300 Total operating expenses 5,250,567 6,306,564 Loss from operations (5,250,567) (6,306,564) Other income (expense): Interest income 17,526 35,767 Interest expense - - Other expense (2,793) (35,781) Total other income (expense) 14,733 (14) Net loss $(5,235,834) $(6,306,578) =========== =========== Basic and diluted loss per share $(0.17) $(0.25) ====== ====== Weighted-average common shares outstanding 31,338,963 24,930,007 ========== ========== Period from August 1, 2005 (inception) through September 30, 2010 ----------------- Grant income $482,235 -------- Operating expenses: Research and development 25,295,877 General and administrative 13,729,507 Total operating expenses 39,025,384 Loss from operations (38,543,149) Other income (expense): Interest income 785,108 Interest expense (1,273,734) Other expense (102,762) Total other income (expense) (591,388) Net loss $(39,134,537) ============ Basic and diluted loss per share Weighted-average common shares outstanding Summary Balance Sheet Data (in thousands) September 30, December 31, 2010 2009 (unaudited) Cash and cash equivalents $4,436 $3,176 Total assets $4,809 $3,620 Stockholders' equity $3,304 $2,982 SOURCE Nile Therapeutics, Inc.
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