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Sunesis Pharmaceuticals Reports First Quarter Financial Results And Recent Highlights

SOUTH SAN FRANCISCO, Calif., May 9, 2013 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported financial results for the quarter ended March 31, 2013. Loss from operations for the three months ended March 31, 2013 was $7.8 million. As of March 31, 2013, cash, cash equivalents and marketable securities totaled $61.0 million.

"We continue to make great progress with the VALOR trial, which has now enrolled 611 patients, keeping us on track to complete full enrollment in 2013," said Daniel Swisher, Chief Executive Officer of Sunesis. "We expect a planned periodic safety analysis of VALOR by the trial's independent Data and Safety Monitoring Board to occur in June, with unblinding expected in the first half of 2014 after reaching 562 events and locking the final study database."

Mr. Swisher added: "We are also pleased to report that the mono-therapy vosaroxin arm of the LI-1 trial in front-line elderly AML completed enrollment of the first 50 patients in April. We now look forward to the first planned interim evaluation later this year. Enrollment of the combination arm continues and an interim evaluation of the first 50 patients on this arm is also expected before year end."

First Quarter 2013 and Recent Highlights

  • Continued strong execution of VALOR trial. Enrollment and execution of the VALOR trial remains on track, with 611 patients enrolled as of yesterday. Enrollment is currently ongoing at more than 100 leading sites in the U.S., Canada, Europe, South Korea, Australia and New Zealand. Target enrollment of approximately 675 patients is expected to be complete by the end of 2013, with unblinding expected in the first half of 2014 after reaching 562 events and locking the final study database.  
  • Continued progress of LI-1 trial . Enrollment in the Less Intensive 1 (LI-1) trial, a Phase 2/3 randomized, controlled trial evaluating novel treatment regimens, including two treatment arms containing vosaroxin, in newly diagnosed elderly acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) patients, has reached 82 vosaroxin-treated patients, including 53 patients in the fully enrolled mono-therapy vosaroxin arm and 29 patients on the combination of vosaroxin with LoDAC arm as of April 29, 2013. Sunesis anticipates the first planned interim evaluations of the LI-1 trial following enrollment of 50 patients per vosaroxin treatment arm to occur in 2013. The LI-1 trial is being conducted by the United Kingdom's National Cancer Research Institute under the direction of Professor Alan K. Burnett, Head of Haematology at Cardiff University.  
  • MLN2480 pan-Raf inhibitor. A poster on the pan-Raf inhibitor MLN2480 titled "MLN2480, an investigational oral pan-Raf kinase inhibitor in patients with relapsed or refractory solid tumors: Phase I study" will be presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

Financial Highlights

  • Cash and investments totaled $61.0 million as of March 31, 2013, as compared to $71.2 million as of December 31, 2012. The decrease of $10.2 million was due to $9.5 million used in operating activities and $0.7 million of principal payments against notes payable, which had a balance of $24.3 million before debt discounts as of March 31, 2013.  
  • Total revenue was $2.0 million for the three months ended March 31, 2013, as compared to nil for the same period in 2012. Revenue in the 2013 period was due to deferred revenue recognized related to the royalty agreement with Royalty Pharma.  
  • Research and development expense increased to $7.4 million for the three months ended March 31, 2013 from $6.6 million during the same period in 2012, primarily due to an increase of $1.0 million in clinical trial expenses, partially offset by a reduction of $0.2 million in outside services and consulting costs.  
  • General and administrative expense for the three months ended March 31, 2013 was $2.4 million, as compared to $2.2 million for the same period in 2012. The increase in 2013 was primarily due to an increase in personnel-related costs.  
  • Interest expense was $0.8 million for the three months ended March 31, 2013, as compared to $0.3 million for the same period in 2012. The increase in 2013 was due to the draw-down of the second tranche of $15.0 million from the 2011 venture loan facility in September 2012.  
  • Other expense, net, was $3.0 million for the three months ended March 31, 2013, as compared to $4.8 million for the same period in 2012. The amounts for each period were primarily comprised of non-cash charges pertaining to the revaluation of warrants issued in the underwritten offering completed in October 2010.  
  • Cash used in operations was $9.5 million for the three months ended March 31, 2013, as compared to $9.3 million for the same period in 2012. Net cash used in the 2013 period resulted primarily from the net loss of $11.6 million and changes in operating assets and liabilities of $1.7 million, partially offset by net adjustments for non-cash items of $3.8 million.  
  • Sunesis reported a loss from operations of $7.8 million for the three months ended March 31, 2013, as compared to $8.8 million for the same period in 2012. Net loss was $11.6 million and $13.9 million for the same respective periods.

Conference Call Information

Sunesis will host an update conference call today, May 9th at 11:00 a.m. Eastern Time. The call can be accessed by dialing (877) 280-4958 (U.S. and Canada) or (857) 244-7315 (international), and entering passcode 39516372. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media - Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the Sunesis website for two weeks.

About VALOR

VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial's target enrollment is approximately 675 patients at more than 100 leading sites in the U.S., Canada, Europe, South Korea, Australia and New Zealand. The VALOR trial is currently enrolling patients, who are randomized in a ratio of 1:1 to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. The trial's primary endpoint is overall survival. For more information on the VALOR trial, please visit www.valortrial.com .

About Vosaroxin

Vosaroxin is a first-in-class anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory acute myeloid leukemia in combination with cytarabine.

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