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May 14, 2009
Nile Therapeutics Reports 2009 First Quarter Financial Results
SAN FRANCISCO, May 14 -- 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 CDNP
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, CDNP,
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
http://www.nilethera.com.
Contact:
Daron Evans
Chief Financial Officer
Nile Therapeutics, Inc.
+1-415-875-7880
info@nilethera.com
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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 our strategy, future operations, outlook, milestones, the success of Nile's product development, future financial position, future financial results, plans and objectives of management are forward-looking statements. We may not actually achieve these plans, intentions or expectations and Nile cautions investors not to place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors that could cause actual results or events to differ materially from the forward-looking statements that we make are described in greater detail in the reports we file with Securities and Exchange Commission, including the "Risk Factors" section in Item 1 of the Form 10-KSB we filed with the Securities and Exchange Commission on March 27, 2008. 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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