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Nile Therapeutics Reports 2009 First Quarter Financial Results
Date:5/14/2009

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
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SOURCE Nile Therapeutics, Inc.
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