Nuvelo, Inc. News
Nuvelo Reports First Quarter 2008 Financial Results and Updated Outlook for 2008
For the first quarter ended
Revenues for the first quarter of 2008 were
Operating expenses for the first quarter of 2008, including
Research and development expenses were
General and administrative expenses were
Restructuring expenses were
The facility exit charge was
Net interest income was
"We are focused on building shareholder value through the aggressive advancement of our pipeline and R&D programs. We just announced positive proof-of-concept data demonstrating NU172's potential for rapid onset and offset of anticoagulation, have put programs in place to accelerate the development of NU206 and plan to designate a candidate from one of our two research programs this year," said Dr.
2008 Guidance and Key Milestones
Nuvelo is reiterating its guidance and expects 2008 net cash used in operating activities to be in the range of
Nuvelo anticipates accomplishing the following near-term milestones: — Initiation of a Phase 1b bolus plus infusion trial with NU172 in healthy volunteers in the second quarter of 2008; — Trial completion and top-line data from the Phase 1b bolus plus infusion trial with NU172 in the third quarter of 2008; — Initiation of a Phase 2 trial with NU172 in medical or surgical procedures in the fourth quarter of 2008 or first quarter of 2009; — Initiation of a Phase 1 trial with NU206 in mucositis in the second quarter of 2008; — Initiation of a Phase 1 single ascending dose trial with NU206 in healthy volunteers in the third quarter of 2008; — Trial completion and top-line data from the Phase 1 single ascending dose trial with NU206 in healthy volunteers in the second half of 2008; — Initiation of a Phase 1b multiple ascending dose trial with NU206 in healthy volunteers in the fourth quarter of 2008 or first quarter of 2009; and — Advancement of a new candidate from either the Wnt Therapeutics or the Leukemia Therapeutics Program in 2008.
Conference Call Information
Nuvelo will hold a conference call and virtual webcast today at
This call is being webcast by Thomson/CCBN and will include a virtual slide presentation. The webcast can be accessed via Nuvelo's website at http://www.nuvelo.com and is also being distributed through the Thomson StreetEvents Network. Individual investors can listen to the call at http://www.earnings.com, Thomson's individual investor portal, powered by StreetEvents. Institutional investors can access the call via Thomson StreetEvents (http://www.streetevents.com), a password-protected event management site.
About Nuvelo
Nuvelo, Inc. is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular disease, cancer and other debilitating medical conditions. Nuvelo's development pipeline includes NU172, a direct thrombin inhibitor in Phase 1 development for use as a potential short-acting anticoagulant during medical or surgical procedures; and preclinical candidate NU206, a Wnt pathway modulator for the potential treatment of chemotherapy/radiation therapy-induced mucositis and inflammatory bowel disease. In addition, Nuvelo is pursuing research programs in leukemia and lymphoma therapeutic antibodies and Wnt signaling pathway therapeutics to further expand its pipeline and create additional partnering and licensing opportunities.
Information about Nuvelo is available at our website at http://www.nuvelo.com or by phoning 650-517-8000.
This press release contains "forward-looking statements," which include statements regarding the timing, progress and anticipated completion of Nuvelo's clinical stage and research programs, the anticipated availability of top line data, projected operating expenses and cash usage and the potential benefits that patients may experience from the use of our clinical stage compounds, which statements are hereby identified as "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery and the regulatory approval process; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; stock market conditions; the impact of competitive products and technological changes; and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo's filings with the SEC, including without limitation Nuvelo's annual report on Form 10-K for the year ended
NUVELO, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share data) (unaudited) Three Months Ended March 31, 2008 2007 Contract revenues $63 $910 Operating expenses: Research and development 11,518 12,725 General and administrative 4,009 5,366 Restructuring 2,470 - Facility exit charge 1,472 - Total operating expenses 19,469 18,091 Operating loss (19,406) (17,181) Interest income, net 998 1,832 Net loss $(18,408) $(15,349) Basic and diluted net loss per share $(0.34) $(0.29) Weighted average shares used in computing basic and diluted net loss per share 53,456 53,252 CONSOLIDATED BALANCE SHEET DATA (in thousands) (unaudited) March 31, 2008 December 31, 2007* Cash and cash equivalents, marketable securities and restricted cash $87,168 $103,567 Working capital 51,271 81,799 Total assets 103,686 120,683 Non-current liabilities 19,874 34,837 Accumulated deficit (488,921) (470,513) Total stockholders' equity 51,623 67,659 * The consolidated balance sheet data as of December 31, 2007 have been derived from the audited financial statements.
SOURCE Nuvelo, Inc.
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