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March 3, 2010
Nile Therapeutics Reports 2009 Fourth Quarter and Full Year Financial Results
SAN MATEO, CA, March 3, 2010 -- Nile Therapeutics, Inc. (NASDAQ: NLTX), a biopharmaceutical company in the development of novel therapeutics for heart failure patients, today announced its fourth quarter and full year financial results for 2009. The company will host a conference call and live webcast to discuss these financial results and provide an update on each of its development programs at 8:30 a.m. EST on March 5, 2010. Interested investors may participate in the conference call by dialing +1-877-303-6918 (USA) or +1-973-638-3210 (international). Participants may also access both the live and archived webcast of the conference call from the homepage and the investor relations section of Nile's website at www.nilethera.com.
Financial Results
For the fourth quarter of 2009, Nile reported a net operating loss of $1.6 million, or $0.06 per share. For the full year, net operating loss was $7.9 million, or $0.31 per share. Weighted-average shares outstanding for the quarter and the year ended December 31, 2008 were 27.0 and 24.5 million, respectively. Nile reported no revenue during the quarter and the year ended December 31, 2009.
As of December 31, 2009, Nile had cash and cash equivalents of $3.2 million compared to $5.5 million as of December 31, 2008. Cash and cash equivalents decreased $2.3 million in the year ended December 31, 2009; $5.8 million was used for operations, and $3.5 million was raised through a private placement of stock and the exercise of stock options and warrants.
Going Concern Qualification
Nile also announced that the audit report included in its Annual Report on Form 10-K for the year ended December 31, 2009 expresses an unqualified audit opinion from its independent registered public accounting firm, Crowe Horwath LLP, but contains an explanatory paragraph relating to the company's ability to continue as a going concern. This announcement is being made pursuant to Nasdaq Marketplace Rule 4350(b)(1)(B), which requires separate disclosure of the receipt of a going concern qualification.
Update on CD-NP Program
During 2009 Nile made progress in the clinical development of CD-NP for the treatment of patients with acute heart failure. In July 2009, the first patient was dosed in a single-blind, placebo-controlled Phase II clinical trial 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, the study contains several exploratory efficacy endpoints to provide insight into the potential for CD-NP to enhance renal function in acute heart failure patients. Nile initially planned to enroll up to 40 patients in the study.
As of March 1, 2010, 30 subjects have completed dosing in study. At the end of 2009, Nile submitted a protocol amendment to enable the company to add up to three additional cohorts of patients, which increases potential enrollment in the study to a total of approximately 75 patients. Interim top-line safety data from the on-going Phase II study suggests that CD-NP is well-tolerated at doses of 1.25 and 2.5 ng/kg/min. Nile expect full results from the expanded study to be available in the second half of 2010. Following analysis of the ongoing Phase II data and subject to such data, the company expects to initiate a Phase IIb dose-ranging, placebo-controlled, double-blind study in acute heart failure patients.
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.
Contact:
Daron Evans
Chief Financial Officer
Nile Therapeutics, Inc.
+1-650-458-2670
info@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, 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.
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