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Sunesis Pharmaceuticals Reports First Quarter 2014 Financial Results And Recent Highlights

Stocks in this article: SNSS

Receives FDA Acceptance for Trademark Name Qinprezo™

Sunesis to Host Conference Call Today at 11:00 AM Eastern Time

SOUTH SAN FRANCISCO, Calif., May 7, 2014 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported financial results for the quarter ended March 31, 2014. Loss from operations for the three months ended March 31, 2014 was $9.0 million. As of March 31, 2014, cash, cash equivalents and marketable securities totaled $70.7 million. Sunesis also announced today that it has received U.S. Food and Drug Administration (FDA) acceptance for the use of Qinprezo™ as the trademark name for its vosaroxin product candidate. The company received a similar acceptance from the European Medicines Agency in 2013.

"We have made tremendous progress in the last several quarters across all our programs, bringing Sunesis closer to becoming an integrated oncology company leading with Qinprezo and a growing pipeline of novel and differentiated therapeutic programs," said Daniel Swisher, Chief Executive Officer of Sunesis. "A cornerstone of our strategy is the successful conclusion of our pivotal, Phase 3 VALOR trial of Qinprezo in first relapsed or refractory AML. We expect to unblind the VALOR trial in the third or fourth quarter of 2014, an event which, with a positive outcome, would transform the treatment of a difficult disease that has seen little innovation in the last 40 years."

Mr. Swisher added: "The coming quarters will also be important for the development of our pipeline, which now includes three proprietary programs and two partnered programs. Supporting this progress is a strong balance sheet, reinforced by a $43 million financing completed in March. This financing includes $95 million in potential future equity funding."

First Quarter 2014 and Recent Highlights

  • Continued progress of VALOR trial. Unblinding of the pivotal, Phase 3 VALOR trial of Qinprezo plus cytarabine in first relapsed or refractory acute myeloid leukemia (AML) is expected in the third or fourth quarter of 2014, after reaching 562 events and locking the final study database. The updated guidance for unblinding of the trial reflects a slowing rate of events among the pool of patients in follow up.  
  • Announced data from ongoing MD Anderson Cancer Center-sponsored trial of Qinprezo and decitabine in frontline AML and high-risk MDS at AACR. In March 2014, Sunesis announced the presentation of updated results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of Qinprezo in combination with decitabine in older patients with previously untreated AML and high-risk myelodysplastic syndrome (MDS). The combination of Qinprezo and decitabine showed robust clinical benefit and good tolerability in older patients with AML and high-risk MDS. The poster presented at the American Association for Cancer Research Annual Meeting 2014 (AACR), titled "Phase I/II study of vosaroxin and decitabine in older patients (pts) with acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS)," is available on the Sunesis website at www.sunesis.com .  
  • Announced updated data from MD Anderson Cancer Center-sponsored trial will be presented at ASCO 2014 Annual Meeting (Poster #383). Updated data from the ongoing MD Anderson Cancer Center-sponsored study will be presented at the 2014 American Society of Clinical Oncology Annual Meeting (ASCO) in Chicago, Illinois. The poster titled "Phase I/II study of vosaroxin and decitabine in older patients with AML and high-risk MDS," will be presented at McCormick Place, S Hall A2, during the Leukemia, Myelodysplasia, and Transplantation Poster Session on Monday, June 2, 2014 from 1:15 p.m. to 5:00 p.m. Central Time.  
  • Appointed Chief Commercial Officer . In February 2014, Sunesis announced the appointment of Joseph I. DePinto to the newly created position of Executive Vice President and Chief Commercial Officer. Mr. DePinto brings over two decades of experience in global commercial operations, including the leadership of the commercial, marketing and strategic development efforts behind a number of prominent oncology products.  
  • Expanded oncology franchise through global licensing agreements with Biogen and Takeda/Millennium . In January 2014, Sunesis announced that it expanded its oncology franchise through separate global licensing agreements for two preclinical kinase inhibitor programs. The first agreement, with Biogen Idec, is for global commercial rights to SNS-062, a potent and selective non-covalently binding oral inhibitor of BTK (Bruton's tyrosine kinase). BTK is a mediator of B-cell receptor signaling, which is integral to the pathogenesis of B-cell malignancies. Sunesis anticipates filing an investigational new drug (IND) application for SNS-062 with the FDA within one year to begin human clinical trials.

The second agreement, with Millennium Pharmaceuticals, Inc., a wholly-owned subsidiary of Takeda Pharmaceuticals Company Limited, is for global commercial rights to several potential first-in class, pre-clinical inhibitors of the novel target PDK1 (phosphoinositide-dependent kinase-1). PDK1 is a key kinase and mediator of PI3K/AKT signaling, a pathway involved in cell growth, proliferation, differentiation, motility and survival. Sunesis anticipates selecting a lead PDK1 development candidate this year to take into IND-enabling studies.

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