SOUTH SAN FRANCISCO, Calif., Aug. 9, 2012 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported financial results for the quarter ended June 30, 2012. Net loss for the three and six months ended June 30, 2012 was $8.6 million and $22.5 million, respectively. As of June 30, 2012, cash, cash equivalents and marketable securities totaled $29.3 million.
Second Quarter 2012 and Recent Highlights
- Continued strong execution of VALOR trial. Enrollment and execution in the VALOR trial continues to be strong, with 391 patients enrolled as of yesterday, which remains on track for the conduct of the interim efficacy and safety analysis in September.
- Announced DSMB Recommendation to Continue VALOR Trial Based on Safety Review. In June, 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.
- Received $1.5 Million Payment From Biogen Idec Related to Kinase Inhibitor Program. In June, Sunesis received a $1.5 million payment from Biogen Idec for the advancement of pre-clinical work under its 2011 amended and restated multi-kinase inhibitor collaboration agreement.
- Received orphan drug designation by European Commission. In April, the European Commission granted 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 (FDA).
- VALOR design poster presented at ASCO 2012. In June,Sunesis presented a 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 Annual Meeting in Chicago.
- 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 Research Annual Meeting in Chicago. The data suggest that MLN2480 has therapeutic anti-cancer activity in both B-Raf mutant and wild-type melanoma tumor models.
- Cash, cash equivalents and marketable securities totaled $29.3 million as of June 30, 2012, as compared to $44.1 million as of December 31, 2011.
- Total revenue was $1.5 million for the three and six months ended June 30, 2012, as compared to nil and $4.0 million for the same periods in 2011. Revenue in the 2012 periods was due to the receipt of a payment of $1.5 million in June 2012 for the advancement of pre-clinical work under the company's 2011 amended and restated multi-kinase inhibitor collaboration agreement with Biogen Idec. Revenue in the 2011 six-month period was due to an upfront payment of $4.0 million from 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 $8.1 million and $14.7 million for the three and six months ended June 30, 2012, as compared to $6.0 million and $10.0 million for the same periods in 2011. The increases in 2012 were primarily due to an increase in clinical and other expenses related to the VALOR trial.
- General and administrative expenses for the three and six months ended June 30, 2012 were $2.2 million and $4.4 million, as compared to $2.0 million and $4.0 million for the same periods in 2011. The increases between the periods were primarily due to higher non-cash stock-based compensation expenses.
- Other expense, net, was $4.3 million for the six months ended June 30, 2012, as compared to net other income of $3.6 million for the same period in 2011. Net other expense for the 2012 period was primarily comprised of non-cash expenses of $4.1 million for the revaluation of the warrants issued in the underwritten offering completed in October 2010 to their fair value as of June 30, 2012. Net other income in the 2011 period included a credit of $3.2 million for a similar revaluation of these warrants.
- Sunesis reported a net loss of $8.6 million and $22.5 million for the three and six months ended June 30, 2012, as compared to net losses of $8.2 million and $6.4 million for the same periods in 2011.
About AMLAML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates there will be approximately 13,780 new cases of AML and 10,200 deaths from AML in the U.S. in 2012. Additionally, it is estimated that the prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom, and Japan) is over 50,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients. About Sunesis Pharmaceuticals 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 Sunesis Pharmaceuticals, Inc. The Sunesis Pharmaceuticals, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8773 This press release contains forward-looking statements, including statements related to the occurrence, result and timing of the DSMB interim analysis, the design, conduct, progress and results of the VALOR trial and other clinical trials relating to our existing licensing agreements, and vosaroxin's effects, efficacy, safety profile and commercial potential as a single agent and in combination with cytarabine. Words such as "will," "provides," "examine," "determine," "decide," "continue," "plan," "estimate," "on track" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to Sunesis' need for substantial additional funding to complete the development and commercialization of vosaroxin, risks related to Sunesis' ability to raise the capital that it believes to be accessible and is required to fully finance the development and commercialization of vosaroxin, the risk that raising funds through lending arrangements may restrict our operations or produce other adverse results, the risk that Sunesis' development activities for vosaroxin could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical studies may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, risks related to the manufacturing of vosaroxin and supply of the active pharmaceutical ingredients required for the conduct of the VALOR trial, the risk of third party opposition to granted patents related to vosaroxin, and the risk that Sunesis' proprietary rights may not adequately protect vosaroxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, Sunesis' Annual Report on Form 10-K for the year ended December 31, 2011 and Sunesis' other filings with the Securities and Exchange Commission, including Sunesis' Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, when available. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
|SUNESIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30,||December 31,|
|Cash and cash equivalents||$ 11,743||$ 9,311|
|Prepaids and other current assets||1,602||1,550|
|Total current assets||30,876||45,665|
|Property and equipment, net||58||74|
|Deposits and other assets||108||130|
|Total assets||$ 31,042||$ 45,869|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable||$ 393||$ 658|
|Accrued clinical expense||3,982||2,370|
|Other accrued liabilities||2,749||1,805|
|Current portion of notes payable||900||--|
|Total current liabilities||15,206||8,383|
|Non-current portion of notes payable||8,737||9,453|
|Non-current portion of deferred rent||--||13|
|Additional paid-in capital||430,748||429,142|
|Accumulated other comprehensive income (loss)||(5)||19|
|Total stockholders' equity||7,099||28,020|
|Total liabilities and stockholders' equity||$ 31,042||$ 45,869|
|Note 1: The condensed consolidated balance sheet as of December 31, 2011 has 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 OPERATIONS AND COMPREHENSIVE INCOME (LOSS)|
|(In thousands, except per share amounts)|
|Three months ended June 30,||Six months ended June 30,|
|License and other revenue||$ 1,500||$ --||$ 1,500||$ 4,000|
|Research and development||8,072||5,950||14,718||10,020|
|General and administrative||2,182||1,975||4,371||3,989|
|Total operating expenses||10,254||7,925||19,089||14,009|
|Loss from operations||(8,754)||(7,925)||(17,589)||(10,009)|
|Other income (expense), net||491||(302)||(4,283)||3,622|
|Unrealized gain (loss) on available-for-sale securities||(13)||21||(24)||33|
|Comprehensive loss||$ (8,592)||$ (8,206)||$ (22,527)||$ (6,354)|
|Basic and diluted loss per common share:|
|Shares used in computing net loss per common share:|
|Net loss per common share:|
|Basic||$ (0.18)||$ (0.18)||$ (0.48)||$ (0.14)|
|Diluted||$ (0.20)||$ (0.18)||$ (0.48)||$ (0.14)|
CONTACT: Investor and Media Inquiries: David Pitts Argot Partners 212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc. 650-266-3717