November 13, 2008
Nile Therapeutics, Inc. Reports 2008 Third Quarter Financial Results
SAN FRANCISCO, Nov. 13 /PRNewswire-FirstCall/ -- Nile Therapeutics, Inc. , a biotechnology company focused on the development of novel drugs for cardiovascular disease, today announced financial results for the three and nine months ended September 30, 2008.
Net operating loss for the three months ended September 30, 2008 was $3.3 million, or $0.14 per share, compared to $5.5 million, or $0.35 per share, for the same period of 2007. Net operating loss for the nine months ended September 30, 2008 totaled $10.2 million, or $0.42 per share, compared to $7.8 million, or $0.54 per share, for the same period of 2007.
Nile reported no revenue for the three and nine months ended September 30, 2008 and 2007, respectively. Research and development expenses were $2.6 million for the three months ended September 30, 2008 compared to $2.2 million for the comparable period of 2007. For the nine months ended September 30, 2008, research and development expenses totaled $7.4 million compared with $3.6 million for the same period of 2007. The quarterly and year-to-date increases were mostly due to increased clinical trial expenses on our lead compound, CD-NP. General and administrative expenses were $0.8 million for the three months ended September 30, 2008 compared to $2.6 million for the comparable period of 2007. For the nine months ended September 30, 2008, general and administrative expenses totaled $3.0 million compared with $3.3 million for the same period of 2007.
At September 30, 2008, Nile had cash and cash equivalents of $7.4 million compared to $10.3 million and $16.2 million on June 30, 2008 and December 31, 2007, respectively. This $8.8 million decrease from December 31, 2007 occurred as cash was used for operations.
"During the quarter we continued to demonstrate the strong potential of our lead compound CD-NP in treating patients with acute heart failure," said Peter Strumph, Chief Executive Officer of Nile. "We are extremely encouraged by our interim Phase 2a clinical trial results to date and look forward to announcing data from the ongoing Phase 1b Maximum Tolerated Dose clinical study of CD-NP in the fourth quarter of 2008. We look forward to continuing to advance the clinical development of CD-NP with the anticipated initiation of our Phase 2b study in early 2009."
Pipeline Development Update CD-NP
CD-NP is a novel chimeric natriuretic peptide in clinical development for the treatment of ADHF. CD-NP was designed to preserve the favorable effects of current therapies while preventing or attenuating the hypotensive response, and enhancing or preserving renal function. The Company, in conjunction with The Mayo Clinic, currently has three ongoing clinical trials, evaluating the potential clinical utility of CD-NP in patients with acute heart failure.
-- As of the third quarter of 2008, Nile continued enrollment into the Phase 1b Maximum Tolerated Dose clinical study of CD-NP. The pace of enrollment is on target with our anticipated announcement of results from this study by year end. The primary objectives of the study are to assess the safety and tolerability of intravenous infusions of CD-NP in patients with heart failure. Key assessments include measurement of blood pressure, heart rate and kidney function. -- As of the third quarter of 2008, The Mayo Clinic dosed its first patient into the National Institutes of Health (NIH) funded Phase 1b Renal clinical study of CD-NP. The primary objective of this study is to assess renal, neurohumoral and non-invasive hemodynamic parameters of intravenous infusions of CD-NP in patients with heart failure. Key assessments include glomerular filtration rate, tubular function, renal plasma flow, urine output and mean arterial pressure. -- As of the third quarter of 2008, Nile announced interim data from its Phase 2a Hemodynamic clinical study of CD-NP. Enrollment in the study is ongoing. The primary objective of the study is to assess hemodynamic effects of intravenous infusions of CD-NP in patients with heart failure. Key assessments include measurement of pulmonary capillary wedge pressure (PCWP), blood pressure and kidney function. 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 need. 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; 2NTX-99, a small molecule, pre-clinical, anti-atherothrombotic agent with nitric oxide donating properties; 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 our strategy, future operations, outlook, milestones, the success of our 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 of our Annual Report on Form 10-KSB, which was 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.
Nile Therapeutics, Inc. (A Development Stage Company) Condensed Statements of Operations (unaudited) Three Months Ended Nine Months Ended September 30, September 30, -------------------- -------------------- 2008 2007 2008 2007 Grant income $ - $ 101,400 $ - $ 101,400 Operating expenses Research and development 2,556,900 2,175,558 7,423,738 3,596,835 General and adminis- trative 818,761 2,562,891 2,977,263 3,284,387 Total operating expenses 3,375,661 4,738,449 10,401,001 6,881,222 Loss from operations (3,375,661) (4,637,049) (10,401,001) (6,779,822) Other income (expense) Interest income 58,451 58,975 290,734 82,937 Interest expense - (970,330) (137) (1,089,344) Other expense (3,679) - (46,523) - Total other Income (expense) 54,772 (911,355) 244,074 (1,006,407) Net loss $(3,320,889) $(5,548,404) $(10,156,927) $(7,786,229) Basic and diluted loss per share $ (0.14) $ (0.35) $ (0.42) $ (0.54) Weighted-average common shares outstanding 24,149,405 15,977,936 24,118,645 14,532,772 Summary Balance Sheet Data September December 30, 2008 31, 2007 (unaudited) Cash & cash Equivalents $ 7,363,926 $16,233,464 Total assets $ 8,408,902 $17,089,328 Total stockholder equity $ 7,490,754 $15,199,932
Nile Therapeutics, Inc.
CONTACT: Daron Evans, Chief Financial Officer of Nile Therapeutics,Inc., +1-415-875-7880, [email protected]
Web Site: http://www.nilethera.com/