SOUTH SAN FRANCISCO, Calif., May 9, 2013 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported financial results for the quarter ended March 31, 2013. Loss from operations for the three months ended March 31, 2013 was $7.8 million. As of March 31, 2013, cash, cash equivalents and marketable securities totaled $61.0 million.
"We continue to make great progress with the VALOR trial, which has now enrolled 611 patients, keeping us on track to complete full enrollment in 2013," said Daniel Swisher, Chief Executive Officer of Sunesis. "We expect a planned periodic safety analysis of VALOR by the trial's independent Data and Safety Monitoring Board to occur in June, with unblinding expected in the first half of 2014 after reaching 562 events and locking the final study database."
Mr. Swisher added: "We are also pleased to report that the mono-therapy vosaroxin arm of the LI-1 trial in front-line elderly AML completed enrollment of the first 50 patients in April. We now look forward to the first planned interim evaluation later this year. Enrollment of the combination arm continues and an interim evaluation of the first 50 patients on this arm is also expected before year end."
First Quarter 2013 and Recent Highlights
Financial Highlights
Conference Call Information
Sunesis will host an update conference call today, May 9th at 11:00 a.m. Eastern Time. The call can be accessed by dialing (877) 280-4958 (U.S. and Canada) or (857) 244-7315 (international), and entering passcode 39516372. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media - Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the Sunesis website for two weeks.
About VALOR
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial's target enrollment is approximately 675 patients at more than 100 leading sites in the U.S., Canada, Europe, South Korea, Australia and New Zealand. The VALOR trial is currently enrolling patients, who are randomized in a ratio of 1:1 to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. The trial's primary endpoint is overall survival. For more information on the VALOR trial, please visit www.valortrial.com.
About Vosaroxin
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. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory acute myeloid leukemia in combination with cytarabine.
About AML
AML 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 14,590 new cases of AML and approximately 10,370 deaths from AML in the U.S. in 2013. 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.
This press release contains forward-looking statements, including statements related to: (i) Sunesis' overall strategy, (ii) the design, conduct, progress, timing and results of the VALOR trial and Sunesis' other clinical programs discussed in this release, (iii) the sufficiency of Sunesis' financial resources and (iv) the progress of the kinase collaboration programs. Words such as "anticipates," "continue," "currently," "expected," "on track," "planned," "potential," "supports," 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, European Commission 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' Annual Report on Form 10-K for the year ended December 31, 2012 and Sunesis' other filings with the Securities and Exchange Commission, including Sunesis' Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, 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 Sunesis' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
SUNESIS PHARMACEUTICALS, INC. | ||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
(In thousands) | ||
March 31, | December 31, | |
2013 | 2012 | |
ASSETS | (Unaudited) | (Note 1) |
Current assets: | ||
Cash and cash equivalents | $ 12,555 | $ 14,940 |
Marketable securities | 48,482 | 56,287 |
Prepaids and other current assets | 1,188 | 1,705 |
Total current assets | 62,225 | 72,932 |
Property and equipment, net | 36 | 43 |
Deposits and other assets | 32 | 42 |
Total assets | $ 62,293 | $ 73,017 |
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Current liabilities: | ||
Accounts payable | $ 1,527 | $ 78 |
Accrued clinical expense | 4,340 | 5,449 |
Accrued compensation | 678 | 1,465 |
Other accrued liabilities | 2,246 | 2,113 |
Current portion of deferred revenue | 7,956 | 7,956 |
Current portion of notes payable | 8,232 | 6,610 |
Warrant liability | 10,922 | 8,070 |
Total current liabilities | 35,901 | 31,741 |
Non-current portion of deferred revenue | 9,679 | 11,668 |
Non-current portion of notes payable | 15,609 | 17,651 |
Commitments | ||
Stockholders' equity: | ||
Common stock | 5 | 5 |
Additional paid-in capital | 457,803 | 457,011 |
Accumulated other comprehensive income | 17 | 38 |
Accumulated deficit | (456,721) | (445,097) |
Total stockholders' equity | 1,104 | 11,957 |
Total liabilities and stockholders' equity | $ 62,293 | $ 73,017 |
Note 1: The condensed consolidated balance sheet as of December 31, 2012 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, 2012. | ||
SUNESIS PHARMACEUTICALS, INC. | ||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||
AND COMPREHENSIVE INCOME (LOSS) | ||
(In thousands, except per share amounts) | ||
Three months ended March 31, |
||
2013 | 2012 | |
(Unaudited) | ||
Revenue: | ||
License and other revenue | $ 1,989 | $ -- |
Total revenues | 1,989 | -- |
Operating expenses: | ||
Research and development | 7,377 | 6,646 |
General and administrative | 2,444 | 2,189 |
Total operating expenses | 9,821 | 8,835 |
Loss from operations | (7,832) | (8,835) |
Interest expense | (831) | (315) |
Other income (expense), net | (2,961) | (4,774) |
Net loss | (11,624) | (13,924) |
Unrealized loss on available-for-sale securities | (21) | (11) |
Comprehensive loss | $ (11,645) | $ (13,935) |
Basic and diluted loss per common share: | ||
Net loss | $ (11,624) | $ (13,924) |
Shares used in computing basic and diluted loss per common share | 51,587 | 46,793 |
Basic and diluted loss per common share | $ (0.23) | $ (0.30) |