Navigation Links
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 $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, 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 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.

                                Three Months Ended     Three Months Ended
                                  March 31, 2009         March 31, 2008
                                ------------------     ------------------
    Grant income                   $             -        $             -
                                    --------------        ---------------
    Operating expenses:
     Research and development            1,324,603              1,978,184
     General and administrative            462,468              1,198,339
                                    --------------        ---------------
     Total operating expenses            1,787,071              3,176,523
                                    --------------        ---------------
     Loss from operations              (1,787,071)            (3,176,523)

    Other income (expense):
     Interest income                        14,686                149,436
     Interest expense                            -                  (137)
     Other expense                         (6,423)               (31,713)
                                    --------------        ---------------
     Total other income (expense)            8,263                117,586
                                    --------------        ---------------
    Net loss                        $  (1,778,808)        $   (3,058,937)
                                    ==============        ===============
    Basic and diluted loss per
     share                          $       (0.07)        $        (0.13)
                                    ==============        ===============
    Weighted-average common shares
     outstanding                        24,149,405             24,099,716
                                    --------------        ---------------


                             Summary Balance Sheet Data
                                  (in thousands)

                                     March 31, 2009     December 31, 2008

    Cash and cash equivalents        $        3,607     $           5,501
    Total assets                     $        4,263     $           6,435
    Stockholders' equity             $        3,484     $           5,104


'/>"/>
SOURCE Nile Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Oxygen Biotherapeutics, Inc. Signs Cooperative Research and Development Agreement With Naval Medical Research Center and Walter Reed Army Institute of Research
2. Transition Therapeutics Announces Third Quarter Fiscal 2009 Financial Results
3. Medivation to Present at the Leerink Swann Novel Cancer Therapeutics Roundtable Conference
4. Nektar Therapeutics to Present at the Deutsche Bank 34th Annual Health Care Conference in Boston
5. Transition Therapeutics to Hold Conference Call on Third Quarter Fiscal 2009 Financial Results on Wednesday, May 13th, at 4:30 P.M. EST
6. Cell Therapeutics, Inc. Announces Single Institutional Investor Purchases $20 Million of Common Stock and Warrants
7. Cell Therapeutics, Inc. Intends to Offer to Exchange up to $89.2 Million of its Outstanding Convertible Notes in a Modified Dutch Auction Tender Offer
8. Cornerstone Therapeutics Reports First Quarter 2009 Financial Results
9. Cornerstone Therapeutics Announces $70 Million Strategic Transaction With Chiesi Farmaceutici SpA
10. Cell Therapeutics Reports 76% Decrease in First Quarter 2009 Net Loss Attributable to Common Shareholders; Completion of Pixantrone NDA Submission on Track for Second Quarter 2009
11. Oxygen Biotherapeutics, Inc. Files Cosmetic Product Ingredient Statement for new Oxycyte-based Cosmetic Gel
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/29/2016)... Georgia (PRWEB) , ... April 29, 2016 , ... On ... rural hospitals across the Southeast, celebrated the signature of Gov. Nathan Deal on SB ... Rep. Geoff Duncan (R - Cumming), offers a 70% tax credit to individuals and ...
(Date:4/29/2016)... ... April 29, 2016 , ... Conditions were ideal for Global ... Park on Sunday, with sunny skies, a light breeze and temperatures in the 60s. ... , The 5k Run and Walk and 1-mile walk were held to increase ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... won the $30,000 Perlman Grand Prize of the 2016 Wharton Business Plan ... the Michelson People’s Choice Award, and the Committee Award for Most ‘Wow Factor,’ ...
(Date:4/29/2016)... , ... April 29, 2016 , ... Melanoma is the deadliest type of skin cancer. ... for the majority of skin cancer deaths. More than 10,000 people are expected to die ... diagnosis is 62, it is the one of the most commonly diagnosed cancers in young ...
(Date:4/29/2016)... , ... April 29, 2016 , ... For those who ... the meal to miss. That was among the many new lifestyle diet tips offered ... recent Sharon Kleyne Hour® Power of Water® radio show. Bonny and Lawrence noted that ...
Breaking Medicine News(10 mins):
(Date:4/27/2016)... 27, 2016 Elekta today announced ... will be the focal point of seven scientific presentations ... Society for Radiotherapy & Oncology, taking place April 29 ... state-of-the-art radiotherapy system and a high-field MRI scanner with ... the patient,s anatomy in real time. The MR-linac is ...
(Date:4/27/2016)... SHAWNEE, Kan. , April 27, 2016 /PRNewswire/ ... Martabano , a senior from the University of ... winner of the Bayer Excellence in Communication Award ... veterinary schools, which were awarded a total of ... Over the last four years, Bayer has provided ...
(Date:4/27/2016)... 27, 2016 Global  urinalysis ... billion by 2022, according to a new report ... (Logo: http://photos.prnewswire.com/prnh/20150105/723757 ) , ... efficiency and accuracy delivered by the new generation ... novel urinalysis instruments and consumables. For instance, the ...
Breaking Medicine Technology: