Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2011 Financial Results and Highlights
"Thanks to the continuing successful execution of our strategic plan, Sunesis today is well positioned to capitalize on the value of vosaroxin, which we believe is the most advanced and promising therapy in development for acute myeloid leukemia," said
Mr. Swisher added: "2012 promises to be a transformational year for Sunesis, as we advance the VALOR trial through the interim analysis, progress towards regulatory filings and prepare the market for the planned launch of vosaroxin in AML."
Fourth Quarter 2011 and Recent Highlights
Announced DSMB Recommendation to Continue VALOR Trial Based on Safety Review. In December,Sunesis announced that the independent Data and Safety Monitoring Board (DSMB) for the VALOR trial completed a planned periodic safety review and recommended that the trial continue as planned without changes to study conduct. Announced appointment of Dr.
Adam R. Craigas Chief Medical Officer. In February, Sunesis announced the appointment of Adam R. Craig, M.B.B.S., Ph.D., M.B.A. to the newly created position of Executive Vice President, Development and Chief Medical Officer. In this position, Dr. Craig will direct Sunesis' R&D organization and global development programs. Announced notice of allowance for U.S. patent application covering vosaroxin compositions. In February, Sunesis announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for U.S. Patent Application No. 12/982,785 claiming certain compositions related to vosaroxin, and provides patent exclusivity to mid-2030 in the United States. A family of corresponding patent applications is pending in the U.S. and internationally. Announced participation in Cardiff Universitysponsored Phase 2/3 trial. In December, Sunesis announced participation in a Phase 2/3 randomized, controlled, multicenter trial evaluating novel treatment regimens, including two regimens containing vosaroxin, against low dose cytarabine in elderly AML or high-risk myelodysplastic syndrome (MDS) patients who are not candidates for intensive chemotherapy. The trial, known as the Less Intensive 1 (LI-1) Trial, is being sponsored by Cardiff Universityand conducted by the United Kingdom's National Cancer Research Institute Haematological Oncology Study Groupunder the direction of Professor Alan K. Burnett. In March 2012, the first patients were enrolled in this trial.
2012 Key Milestones
VALOR interim analysis: Sunesis expects the planned interim analysis of the VALOR trial by the DSMB to occur in the third quarter of 2012. As previously announced, the DSMB will meet to examine pre-specified efficacy and safety data sets and decide whether to 1) stop the trial early for efficacy or for futility; 2) continue the study to its planned unblinding, expected in mid-2013; or 3) recommend a one-time "adaptive" sample size increase with unblinding expected in early 2014. European orphan drug designation for vosaroxin: Sunesis expects a decision from the
European Commissionregarding orphan drug designation for vosaroxin for the treatment of AML. Kinase inhibitors programs: Sunesis expects Millennium Pharmaceuticals, Inc.will present data from the pan-Raf kinase inhibitor program at the American Association of Cancer Researchmeeting in Chicagoon April 1, 2012. The company also expects that other kinase collaboration programs with Biogen Idecand Millennium will continue to progress toward the clinic.
Cash, cash equivalents and marketable securities totaled
$44.1 millionas of December 31, 2011, as compared to $53.4 millionas of December 31, 2010. Revenues for the three months and year ended December 31, 2011were nil and $5.0 million, as compared to $6,000and $33,000for the same periods in 2010. Revenue in 2011 was comprised of an upfront payment of $4.0 millionthat was received from Millennium in relation to the agreements that the company entered into with Biogen Idecand Millennium in March 2011, and $1.0 millionfrom the recognition of deferred revenue related to the sale of certain intellectual property rights to SARcode, which was recorded following the repayment of three promissory notes by SARcode in August 2011. Research and development expenses increase to $6.3 millionand $22.6 millionfor the three months and year ended December 31, 2011, as compared to $4.9 millionand $14.4 millionfor the same periods in 2010. The increases were primarily due to the ramp-up of the VALOR trial and related manufacturing and drug supply activities. General and administrative expenses for the three months and year ended December 31, 2011were $2.2 millionand $8.3 million, as compared to $1.8 millionand $7.0 millionfor the same periods in 2010. The increases of were primarily due to increased personnel and professional service costs. Sunesis reported net losses of $8.7 millionand $20.1 millionfor the three months and year ended December 31, 2011, as compared to $10.1 millionand $24.6 millionfor the same periods in 2010. Net loss for 2011 included net non-cash credits of $5.9 millionrelated to the revaluation of warrants issued as part of the underwritten offering in October 2010to their fair value as of December 31, 2011. Net loss in each of the periods in 2010 reflect a non-cash charge of $3.7 millionfor the revaluation of these warrants to their fair value as of December 31, 2010. Cash used in operations was $7.3 millionand $22.8 millionfor the three months and year ended December 31, 2011, as compared to $4.2 millionand $19.4 millionfor the same periods in 2010. In October 2011, Sunesis entered into a $25.0 milliontranched loan facility. Under the terms of the loan agreement, Sunesis received $10.0 millionupon closing, with the remaining $15 millionavailable for draw at the company's discretion following the planned interim analysis of the VALOR trial by the DSMB, subject to certain conditions specified in the loan agreement.
Conference Call Information
The Company will host a conference call today,
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial is expected to enroll 450 evaluable patients at more than 110 leading sites in the U.S.,
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.
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow.
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit http://www.sunesis.com.
This press release contains forward-looking statements, including statements related to Sunesis' strategy, the sufficiency of Sunesis' intellectual property estate and the patent exclusivity period for vosaroxin in
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SUNESIS PHARMACEUTICALS, INC.CONSOLIDATED BALANCE SHEETS (In thousands) December 31, December 31, 2011 2010 ASSETS (Unaudited) (Note 1) Current assets: Cash and cash equivalents $ 9,311 $ 14,223 Marketable securities 34,804 39,173 Prepaids and other current assets 1,550 1,286 Total current assets 45,665 54,682 Property and equipment, net 74 116 Deposits and other assets 130 60 Total assets $ 45,869 $ 54,858 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 658 $ 416 Accrued clinical expense 2,370 1,574 Accrued compensation 1,274 1,013 Other accrued liabilities 1,805 1,406 Warrant liability 2,276 8,154 Total current liabilities 8,383 12,563 Non-current portion of notes payable 9,453 -- Non-current portion of deferred rent 13 48 Commitments Stockholders' equity: Common stock 5 5 Additional paid-in capital 429,142 423,262 Accumulated other comprehensive income (loss) 19 (15) Accumulated deficit (401,146) (381,005) Total stockholders' equity 28,020 42,247 Total liabilities and stockholders' equity $ 45,869 $ 54,858 Note 1: The consolidated balance sheet as of December 31, 2010has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2010.
SUNESIS PHARMACEUTICALS, INC.CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (In thousands, except per share amounts) Three months ended December 31, Year ended December 31, 2011 2010 2011 2010 (Unaudited) (Unaudited) (Note 2) Revenue: Collaboration revenue $ - $ - $ - $ 27 License and other revenue - 6 5,000 6 Total revenues - 6 5,000 33 Operating expenses: Research and development 6,326 4,873 22,563 14,433 General and administrative 2,159 1,785 8,303 7,005 Total operating expenses 8,485 6,658 30,866 21,438 Loss from operations (8,485) (6,652) (25,866) (21,405) Other income (expense), net (255) (3,419) 5,725 (3,182) Net loss (8,740) (10,071) (20,141) (24,587) Unrealized gain (loss) on available-for-sale securities (1) (23) 34 (15) Comprehensive loss $ (8,741) $ (10,094) $ (20,107) $ (24,602) Basic and diluted loss per common share: Net loss (8,740) (10,071) (20,141) (24,587) Shares used in computing basic and diluted net loss per common share 46,733 43,879 46,412 24,860 Basic and diluted net loss per common share $ (0.19) $ (0.23) $ (0.43) $ (0.99) Note 2: The consolidated statement of operations for the year ended December 31, 2010has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2010.
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717