Sunesis Pharmaceuticals Reports First Quarter Financial Results and Recent Highlights
"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
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."
Continued strong execution of VALOR trial. Enrollment and execution of the VALOR trial remains on track, with 611 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. Targetenrollment of approximately 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 82 vosaroxin-treated patients, including 53 patients in the fully enrolled mono-therapy vosaroxin arm and 29 patients on the combination of vosaroxin with LoDAC arm as of
April 29, 2013. Sunesis anticipates the first planned interim evaluations of the LI-1 trial following enrollment of 50 patients per vosaroxin treatment arm to occur in 2013. The LI-1 trial is being conducted by the United Kingdom's National Cancer Research Instituteunder the direction of Professor Alan K. Burnett, Head of Haematology at Cardiff University.
MLN2480 pan-Raf inhibitor. A poster on the pan-Raf inhibitor MLN2480 titled "MLN2480, an investigational oral pan-Raf kinase inhibitor in patients with relapsed or refractory solid tumors: Phase I study" will be presented at the 2013
American Society of Clinical Oncology( ASCO) Annual Meeting in Chicago, Illinois.
Cash and investments totaled
$61.0 millionas of March 31, 2013, as compared to $71.2 millionas of December 31, 2012. The decrease of $10.2 millionwas due to $9.5 millionused in operating activities and $0.7 millionof principal payments against notes payable, which had a balance of $24.3 millionbefore debt discounts as of March 31, 2013.
Total revenue was
$2.0 millionfor the three months ended March 31, 2013, as compared to nil for the same period in 2012. Revenue in the 2013 period was due to deferred revenue recognized related to the royalty agreement with Royalty Pharma.
Research and development expense increased to
$7.4 millionfor the three months ended March 31, 2013from $6.6 millionduring the same period in 2012, primarily due to an increase of $1.0 millionin clinical trial expenses, partially offset by a reduction of $0.2 millionin outside services and consulting costs.
General and administrative expense for the three months ended
March 31, 2013was $2.4 million, as compared to $2.2 millionfor the same period in 2012. The increase in 2013 was primarily due to an increase in personnel-related costs.
Interest expense was
$0.8 millionfor the three months ended March 31, 2013, as compared to $0.3 millionfor the same period in 2012. The increase in 2013 was due to the draw-down of the second tranche of $15.0 millionfrom the 2011 venture loan facility in September 2012.
Other expense, net, was
$3.0 millionfor the three months ended March 31, 2013, as compared to $4.8 millionfor the same period in 2012. The amounts for each period were primarily comprised of non-cash charges pertaining to the revaluation of warrants issued in the underwritten offering completed in October 2010.
Cash used in operations was
$9.5 millionfor the three months ended March 31, 2013, as compared to $9.3 millionfor the same period in 2012. Net cash used in the 2013 period resulted primarily from the net loss of $11.6 millionand changes in operating assets and liabilities of $1.7 million, partially offset by net adjustments for non-cash items of $3.8 million.
Sunesis reported a loss from operations of
$7.8 millionfor the three months ended March 31, 2013, as compared to $8.8 millionfor the same period in 2012. Net loss was $11.6 millionand $13.9 millionfor the same respective periods.
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's target enrollment is approximately 675 patients at more than 100 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. Both the
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: (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
|SUNESIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|March 31,||December 31,|
|Cash and cash equivalents||$ 12,555||$ 14,940|
|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|
|Accounts payable||$ 1,527||$ 78|
|Accrued clinical expense||4,340||5,449|
|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|
|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|
|Additional paid-in capital||457,803||457,011|
|Accumulated other comprehensive income||17||38|
|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
|License and other revenue||$ 1,989||$ --|
|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)|
|Other income (expense), net||(2,961)||(4,774)|
|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)|
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717