Sunesis Pharmaceuticals Reports First Quarter 2012 Financial Results and Highlights
"Sunesis is highly focused on the successful execution of our Phase 3 VALOR trial in acute myeloid leukemia as we prepare for future regulatory and commercial milestones to realize vosaroxin's significant potential. We have now enrolled 317 patients and remain on track to conduct a pre-specified interim analysis in the third quarter," said
First Quarter 2012 and Recent Highlights
Continued strong execution of VALOR trial. Enrollment and execution in the VALOR trial continues to be strong, with 317 patients enrolled as of yesterday, which remains on track for the conduct of the interim analysis in the third quarter of this year. Announced
$25.0 millionvosaroxin royalty agreement with Royalty Pharma. In March, Sunesis announced that Royalty Pharmaagreed to pay Sunesis $25.0 million, under certain circumstances related to the successful development of vosaroxin, to acquire a royalty on future worldwide net sales of vosaroxin on terms and conditions previously disclosed. Granted U.S. patent covering vosaroxin compositions. In March, the U.S. Patent and Trademark Office granted Sunesis Patent No. US 8,138,202 B2 covering certain compositions related to vosaroxin, which provides patent exclusivity through mid-2030 in the United States. A family of corresponding patent applications is pending internationally. Received orphan drug designation by European Commission.In April, the European Commissiongranted orphan drug designation to vosaroxin for the treatment of acute myeloid leukemia (AML). The designation provides for 10 years of marketing exclusivity subsequent to product approval in Europe. Vosaroxin has previously received orphan drug and fast track designations from the U.S. Food and Drug Administration. MLN2480, pan-RAF inhibitor, featured in "New Drugs on the Horizon" at AACR 2012. In April, Millennium Pharmaceuticals, Inc.presented preclinical data on MLN2480 at the 2012 American Association of Cancer ResearchAnnual Meeting in Chicago. The data suggest that MLN2480 has therapeutic anti-cancer activity in both B-Raf mutant and wild-type melanoma tumor models. Dosed first patient in Cardiff Universitysponsored Less Intensive 1 (LI-1) Trial. In March, patient dosing began in the Cardiff Universitysponsored Phase 2/3 randomized, controlled, multicenter LI-1 Trial, which is 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. N VALOR design poster presentation accepted for ASCO2012. Sunesis will present the poster titled "VALOR, an adaptive design, pivotal phase III trial of vosaroxin or placebo in combination with cytarabine in first relapsed or refractory acute myeloid leukemia" at the 2012 American Society of Clinical Oncology( ASCO) Annual Meeting in Chicago.
Cash, cash equivalents and marketable securities totaled
$34.9 millionas of March 31, 2012, as compared to $44.1 millionas of December 31, 2011. Total revenue was nil for the three months ended March 31, 2012, as compared to $4.0 millionfor the same period in 2011. Revenue in the 2011 period was due to an upfront payment of $4.0 millionfrom Millennium Pharmaceuticals, Inc.as part of the assignment of licenses for two oncology programs to it in March 2011. Research and development expenses increased to $6.6 millionfor the three months ended March 31, 2012, as compared to $4.1 millionfor the same period in 2011. The increase in 2012 was primarily due to an increase in clinical and other expenses related to the VALOR trial. General and administrative expenses for the three months ended March 31, 2012were $2.2 million, as compared to $2.0 millionfor the same period in 2011. The increase in 2012 was primarily due to higher non-cash stock-based compensation expenses. Other expense, net, was $4.8 millionfor the three months ended March 31, 2012, as compared to net other income of $3.9 millionfor the same period in 2011. Net other expense for the 2012 period was primarily comprised of a non-cash expense of $4.9 millionfor the revaluation of warrants issued in the underwritten offering completed in October 2010to their fair value as of March 31, 2012. Sunesis reported a net loss of $13.9 millionfor the three months ended March 31, 2012, as compared to net income of $1.8 millionfor the same period in 2011.
Conference Call Information
Sunesis will host an update 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.
SUNESIS and the logos are trademarks of
This press release contains forward-looking statements, including statements related to the occurrence and timing of the DSMB interim analysis, the design, conduct, progress and results of the VALOR trial and other clinical trials, the sufficiency of Sunesis' intellectual property estate and the patent exclusivity period for vosaroxin in
SUNESIS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) March 31, December 31, 2012 2011 ASSETS (Unaudited) (Note 1) Current assets: Cash and cash equivalents $ 5,282 $ 9,311 Marketable securities 29,594 34,804 Prepaids and other current assets 1,855 1,550 Total current assets 36,731 45,665 Property and equipment, net 66 74 Deposits and other assets 118 130 Total assets $ 36,915 $ 45,869 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 869 $ 658 Accrued clinical expense 2,564 2,370 Accrued compensation 580 1,274 Other accrued liabilities 1,513 1,805 Current portion of notes payable 50 -- Warrant liability 7,155 2,276 Total current liabilities 12,731 8,383 Non-current portion of notes payable 9,496 9,453 Non-current portion of deferred rent 3 13 Commitments Stockholders' equity: Common stock 5 5 Additional paid-in capital 429,742 429,142 Accumulated other comprehensive income 8 19 Accumulated deficit (415,070) (401,146) Total stockholders' equity 14,685 28,020 Total liabilities and stockholders' equity $ 36,915 $ 45,869 Note 1: The condensed consolidated balance sheet as of December 31, 2011has 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, 2011.
SUNESIS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (In thousands, except per share amounts) Three months ended
March 31, 2012 2011 (Unaudited) Revenue: License and other revenue $ -- $ 4,000 Total revenues -- 4,000 Operating expenses: Research and development 6,646 4,070 General and administrative 2,189 2,014 Total operating expenses 8,835 6,084 Loss from operations (8,835) (2,084) Interest expense (315) -- Other income (expense), net (4,774) 3,924 Net income (loss) (13,924) 1,840 Unrealized gain (loss) on available-for-sale securities (11) 12 Comprehensive income (loss) $ (13,935) $ 1,852 Net income (loss) per common share: Net income (loss) (13,924) 1,840 Shares used in computing net income (loss) per common share: Basic 46,793 45,894 Diluted 46,793 47,866 Net income (loss) per common share: Basic $ (0.30) $ 0.04 Diluted $ (0.30) $ 0.04
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717