SOUTH SAN FRANCISCO, Calif., March 13, 2013 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported financial results for the fourth quarter and year ended December 31, 2012. Loss from operations for the three months and year ended December 31, 2012 was $8.1 million and $34.6 million, respectively. As of December 31, 2012, cash, cash equivalents and marketable securities totaled $71.2 million. "Last year was a transformational year for Sunesis, one which brought us several steps closer to realizing vosaroxin's potential as a new treatment standard in AML," said Daniel Swisher, Chief Executive Officer of Sunesis. "We continue to make progress with the VALOR trial, which has now enrolled 563 patients, and remain on track to both complete the target enrollment of approximately 675 patients in 2013 and unblind the study and announce top-line results in the first half of 2014. With a strong balance sheet, Sunesis is well funded to conduct VALOR through to data read-out and to prepare for the corresponding regulatory and pre-launch activities for vosaroxin." Mr. Swisher added: "While VALOR moves towards completion, we continue to support the important progress in the NCRI-sponsored LI-1 Phase 2/3 trial and in our kinase inhibitor collaborations with Biogen Idec and Millennium Pharmaceuticals." Fourth Quarter 2012 and Recent Highlights
- Continued strong execution of VALOR trial. Enrollment and execution of the VALOR trial remains on track, with 563 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 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 62 vosaroxin-treated patients as of March 5, 2013. LI-1 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. - Received new U.S. patent in collaboration with Takeda/Millennium. In October 2012, Sunesis and Millennium were granted a composition of matter patent in the U.S. covering the MLN2480 pan-Raf inhibitor currently in clinical development. This patent is expected to expire in 2031.2013 Key Milestones VALOR
- Completion of enrollment. Sunesis remains on track to complete full enrollment of the VALOR trial in 2013.
- Interim safety analysis. Sunesis expects a planned interim safety analysis of VALOR by the trial's independent Data and Safety Monitoring Board to occur in June 2013.
- First interim analyses. Sunesis anticipates the first two planned interim assessments of the LI-1 trial in 2013 following enrollment of 50 evaluable patients in the respective treatment arms containing vosaroxin. Various treatment options will be evaluated in a randomized Phase 2/3 design with primary endpoints of overall survival, complete remission rate and duration of response. Treatment arms that exhibit promising results are expected to continue enrolling up to a total of 200 patients per arm.
- Initiation of investigator sponsored trials. Sunesis is evaluating additional indications and trials for vosaroxin, and expects to support the initiation of additional investigator sponsored trials in MDS and AML at leading centers in 2013.
- Expansion of the intellectual property estate. Sunesis expects to secure additional patents in 2013, with the goal of supporting its global vosaroxin patent estate and intellectual property strategy. The company's multi-layered patent portfolio currently supports market exclusivity for vosaroxin to 2030 in the U.S., and beyond 2025 in multiple geographies internationally.
- Continued progress with partnered kinase inhibitor programs. Sunesis currently has partnered kinase inhibitor programs in oncology with Millennium Pharmaceuticals and immunology with Biogen Idec.
- Cash and investments totaled $71.2 million as of December 31, 2012, as compared to $44.1 million as of December 31, 2011. The increase of $27.1 million was primarily due to the receipt of $25.0 million under a royalty agreement with Royalty Pharma; the draw-down of the second tranche of $15.0 million from the 2011 venture loan facility; net proceeds from sales of common stock under controlled equity offering agreements of $17.6 million; and proceeds from the exercise of warrants, stock options and stock purchase rights of $1.9 million, partially offset by other net operating cash outflows. As of September 30, 2012, outstanding debt totaled $25.0 million.