Nile Therapeutics Reports 2009 Third Quarter Financial Results

http://www.businesswire.com/news/home/20091112006153/en

SAN MATEO, Calif.--(Business Wire)--
Nile Therapeutics, Inc. (NASDAQ: NLTX), a company focused on the development of
novel therapeutics for heart failure patients, today announced its third quarter
financial results for 2009.

Financial Results

For the three months ended September, 30 2009, Nile reported a net loss of
approximately $2.0 million, or $0.08 per share, compared to a net loss of
approximately $3.3 million, or $0.14 per share, during the third quarter of
2008. Weighted-average shares outstanding for the quarter were 26.5 million.

Net cash used in operating activities in the third quarter of 2009 was $1.0
million. As of September 30, 2009, Nile had cash and cash equivalents of
approximately $4.2 million compared to approximately $5.5 million as of December
31, 2008.

Update on CD-NP

In August 2009, Nile completed dosing of the first patient in a single-blind,
placebo-controlled Phase 2 study 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 mild to moderate renal insufficiency. Additional
endpoints will include assessments of CD-NP`s ability to relieve symptoms of
acute heart failure and its effects on biomarkers of heart failure and renal
function. The study is expected to enroll approximately 30 to 40 patients in the
United States, Germany and Israel and will evaluate up to 3 dosages of CD-NP.
Nile expects to announce results of the study in first half of 2010.

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,
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, 2008 filed with the Securities and Exchange Commission on March 12,
2009 and amended on April 23, 2009. 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

Three months ended Sept. 30, Nine months ended Sept. 30,

2009 2008 2009 2008

Grant income $ - $ - - $ -

Operating expenses:
Research and development 1,149,232 2,556,900 3,577,264 7,423,738
General and administrative 869,143 818,761 2,729,300 2,977,263

Total operating expenses 2,018,375 3,375,661 6,306,564 10,401,001

Loss from operations (2,018,375 ) (3,375,661 ) (6,306,564 ) (10,401,001 )

Other income (expense):
Interest income 15,194 58,451 35,767 290,734
Interest expense - - - (137 )
Other expense (24,499 ) (3,679 ) (35,781 ) (46,523 )

Total other income (expense) (9,305 ) 54,772 (14 ) 244,074

Net loss $ (2,027,680 ) $ (3,320,889 ) (6,306,578 ) $ (10,156,927 )

Basic and diluted loss per share $ (0.08 ) $ (0.14 ) (0.25 ) $ (0.42 )

Weighted-average common shares outstanding 26,491,211 24,149,405 24,930,007 24,118,645

Summary Balance Sheet Data
(in thousands)

September 30, 2009 December 31, 2008

Cash and cash equivalents $ 4,224 $ 5,501
Total assets $ 4,829 $ 6,435
Stockholders' equity $ 3,984 $ 5,104

Nile Therapeutics, Inc.
Daron Evans, +1-650-458-2670
Chief Financial Officer
info@nilethera.com

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