Full Press Release Details
Therapeutics Reports 2009 Second Quarter Financial Results
SAN FRANCISCO, CA, August 13,
2009 -- Nile Therapeutics, Inc. (NASDAQ: NLTX), a company focused on the
development of novel therapeutics for heart failure patients, today announced
its second quarter financial results for 2009.
second quarter of 2009, Nile reported a net loss of approximately $2.5 million,
or $0.10 per share, compared to a net loss of approximately $3.8 million, or
$0.16 per share, during the second quarter of 2008. Weighted-average shares
outstanding for the quarter were 24.1 million.
used in operating activities in the second quarter of 2009 was $1.8 million. As
of June 30, 2009, Nile had cash and cash equivalents of approximately $1.8
million compared to approximately $5.5 million as of December 31,
to the end of the second quarter of 2009, Nile completed a private placement of
common stock and warrants to purchase additional stock for aggregate proceeds of
approximately $3.4 million. The private placement closed on July 15,
2009, Nile completed dosing 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.
expects to announce interim results of the study later this year, with results
from the full study available in 2010.
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. 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.
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
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.
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2009 | 2008 | 2009 | 2008 | |||||||||||||
| Grant income | $ | - | $ | - | - | $ | - | |||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,103,428 | 2,888,654 | 2,428,032 | 4,866,838 | ||||||||||||
| General and administrative | 1,397,689 | 960,164 | 1,860,157 | 2,158,503 | ||||||||||||
| Total operating expenses | 2,501,117 | 3,848,818 | 4,288,189 | 7,025,341 | ||||||||||||
| Loss from operations | (2,501,117 | ) | (3,848,818 | ) | (4,288,189 | ) | (7,025,341 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 5,886 | 82,848 | 20,573 | 232,284 | ||||||||||||
| Interest expense | - | - | - | (137 | ) | |||||||||||
| Other expense | (4,859 | ) | (11,131 | ) | (11,282 | ) | (42,844 | ) | ||||||||
| Total other income (expense) | 1,027 | 71,717 | 9,291 | 189,303 | ||||||||||||
| $ | (2,500,090 | ) | $ | (3,777,101 | ) | (4,278,898 | ) | $ | (6,836,038 | ) | ||||||
| Basic and diluted loss per share | $ | (0.10 | ) | $ | (0.16 | ) | (0.18 | ) | $ | (0.28 | ) | |||||
| Weighted-average common shares outstanding | 24,149,405 | 24,106,341 | 24,149,405 | 24,103,010 |
| Summary Balance Sheet Data |
| (in thousands) |
| June 30, 2009 | December 31, 2008 | |||||||
| Cash and cash equivalents | $ | 1,770 | $ | 5,501 | ||||
| Total assets | $ | 2,254 | $ | 6,435 | ||||
| Stockholders' equity | $ | 1,814 | $ | 5,104 |