Sunesis Pharmaceuticals Reports Second Quarter Financial Results and Recent Highlights
VALOR Enrollment Exceeds 675 Patients
Cardiff University-Sponsored LI-1 Trial Monotherapy Treatment Arm Evaluated by DMEC
Investigator-Sponsored Phase I/II Trial Evaluating Vosaroxin in Combination with Decitabine in AML and MDS Initiated at
Sunesis to Host Conference Call Today at
"We continue to make substantial progress with the VALOR trial, a study with transformational potential in the treatment of AML," said
Mr. Swisher added: "As to the
Continued strong execution of VALOR trial. In June, the independent Data and Safety Monitoring Board (DSMB) for the VALOR trial completed its fifth periodic safety review and recommended that the trial continue as planned without changes to study conduct. Per protocol, enrollment of the VALOR trial is continuing to 712 patients. As of
July 29, 2013, over 675 patients have been enrolled, with full enrollment expected by the end of the third quarter of 2013. Unblinding is expected in the first half of 2014 after reaching 562 events and locking the final study database.
Initiation of Investigator-Sponsored Phase I/II Trial Evaluating Vosaroxin in Combination with Decitabine in Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome. Sunesis announced the initiation of a Phase I/II investigator-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The trial is being conducted at the
MD Anderson Cancer Centerat the University of Texasunder the direction of Naval Daver, M.D., Assistant Professor, Department of Leukemiaand Farhad Ravandi, M.D., Professor of Medicine, Department of Leukemiaand a principal investigator of VALOR. The open-label, single-arm trial is expected to enroll up to approximately 84 patients who will be treated with vosaroxin intravenously on days one and four in combination with decitabine for five consecutive days.
The primary endpoints of the Phase I trial are to determine the safety, maximum tolerated dose, and dose limiting toxicity of vosaroxin in combination with decitabine in patients with high-risk MDS or AML who are unable or unwilling to receive standard cytarabine plus anthracycline based chemotherapy. The primary endpoint of the Phase II trial is to determine the efficacy of the combination based on achievement of complete remission (CR) and CR with incomplete blood count recovery (CRi). Secondary endpoints include safety, CR duration, leukemia-free survival, and overall survival.
LI-1 trial update. Sunesis has been informed that the
Cardiff University-sponsored LI-1 trial's Data Monitoring and Ethics Committee (DMEC) will be recommending to discontinue the monotherapy vosaroxin arm as it did not meet the pre-specified criteria for advancement. Enrollment of the first 50 patients in the combination arm of vosaroxin and LoDAC is now near completion and the first interim evaluation of that arm is expected to take place before year end. The LI-1 trial is being conducted under the direction of Professor Alan K. Burnett, Head of Haematology at Cardiff University.
Announced peer reviewed publication featuring vosaroxin. In May, Sunesis announced the publication of a peer-reviewed paper in Expert Opinion on Pharmacotherapy entitled "Vosaroxin: a new valuable tool with the potential to replace anthracyclines in the treatment of AML?" In addition to an overview of the chemistry, pharmacokinetics and clinical development of vosaroxin, the paper explores the potential advantages of vosaroxin over anthracycline therapy, including overcoming resistance mechanisms, more site-selective DNA damage, and reduced formation of DNA adducts and reactive oxygen species, resulting in better tolerability.
Strengthened Board of Directors. In June, Sunesis announced the appointment of
Steve Carchedito the Sunesis Board of Directors. Mr. Carchedi brings more than 30 years of commercial industry experience with GE Healthcare, Endo Pharmaceuticals, Enzon Pharmaceuticals, Johnson & Johnson and Bristol Myers Squibb, focused in Oncology, Neurology, Urology, Endocrinology and Cardiology.
Cash and investments totaled
$49.6 millionas of June 30, 2013, as compared to $71.2 millionas of December 31, 2012. The decrease of $21.6 millionwas primarily due to $19.0 millionof cash used in operating activities and $2.8 millionof principal payments against notes payable, which had an outstanding balance of $22.0 millionas of June 30, 2013.
Total revenue was
$2.0 millionand $4.0 millionfor the three and six months ended June 30, 2013, as compared to $1.5 millionfor each of the same periods in 2012. Revenue in the 2013 periods was due to deferred revenue recognized related to the royalty agreement with Royalty Pharma. Revenue in the 2012 periods was due to the receipt of a payment of $1.5 millionfrom Biogen Idecin June 2012for the advancement of pre-clinical work under the current agreement with Biogen Idec.
Research and development expense totaled
$7.7 millionand $15.1 millionfor the three and six months ended June 30, 2013, as compared to $8.1 millionand $14.7 millionduring the same periods in 2012. The decrease between the comparable three month periods was primarily due to a decrease of $0.9 millionin drug manufacturing costs, partially offset by an increase in clinical trial expenses of $0.5 million. The increase between the comparable six month periods was primarily due to increased clinical trial expenses.
General and administrative expenses for the three and six months ended
June 30, 2013were $2.9 millionand $5.3 million, as compared to $2.2 millionand $4.4 millionfor the same periods in 2012. The increases between the comparable periods were primarily due to higher personnel and professional service costs.
Interest expense was
$0.8 millionand $1.6 millionfor the three and six months ended June 30, 2013, as compared to $0.3 millionand $0.6 millionfor the same periods 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.
Net other income was
$1.2 millionfor the three months ended June 30, 2013, as compared to $0.5 millionfor the same period in 2012. Net other expense was $1.8 millionfor the six months ended June 30, 2013, as compared to $4.3 millionfor the same period in 2012. The amounts for each period were primarily comprised of non-cash charges or credits for the revaluation of warrants issued in the underwritten offering completed in October 2010.
Cash used in operations was
$19.0 millionfor the six months ended June 30, 2013, as compared to $15.1 millionfor the same period in 2012. Net cash used in the 2013 period resulted primarily from the net loss of $19.8 millionand changes in operating assets and liabilities of $3.2 million, partially offset by net adjustments for non-cash items of $3.9 million.
Sunesis reported a loss from operations of
$8.6 millionand $16.4 millionfor the three and six months ended June 30, 2013, as compared to $8.8 millionand $17.6 millionfor the same periods in 2012. Net loss was $8.2 millionand $19.8 millionfor the three and six months ended June 30, 2013as compared to $8.6 millionand $22.5 millionfor the same periods in 2012.
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 712 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 the design, conduct, progress, timing and results of the VALOR trial, the LI-1 trial and Sunesis' other clinical programs discussed in this release. Words such as "progress," "expect," "to occur," "will," "complete," "continue," "look forward to," "towards," "target," remain," "potential," "strengthened," 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|
|June 30,||December 31,|
|Cash and cash equivalents||$ 6,605||$ 14,940|
|Prepaids and other current assets||998||1,705|
|Total current assets||50,580||72,932|
|Property and equipment, net||31||43|
|Deposits and other assets||23||42|
|Total assets||$ 50,634||$ 73,017|
|LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)|
|Accounts payable||$ 2,109||$ 78|
|Accrued clinical expense||3,937||5,449|
|Other accrued liabilities||1,973||2,113|
|Current portion of deferred revenue||7,956||7,956|
|Current portion of notes payable||8,488||6,610|
|Total current liabilities||35,238||31,741|
|Non-current portion of deferred revenue||7,690||11,668|
|Non-current portion of notes payable||13,492||17,651|
|Stockholders' equity (deficit):|
|Additional paid-in capital||459,120||457,011|
|Accumulated other comprehensive income||--||38|
|Total stockholders' equity (deficit)||(5,786)||11,957|
|Total liabilities and stockholders' equity (deficit)||$ 50,634||$ 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
Six months ended
|License and other revenue||$ 1,989||$ 1,500||$ 3,978||$ 1,500|
|Research and development||7,674||8,072||15,051||14,718|
|General and administrative||2,889||2,182||5,333||4,371|
|Total operating expenses||10,563||10,254||20,384||19,089|
|Loss from operations||(8,574)||(8,754)||(16,406)||(17,589)|
|Other income (expense), net||1,152||491||(1,809)||(4,283)|
|Unrealized loss on available-for-sale securities||(17)||(13)||(38)||(24)|
|Comprehensive loss||$ (8,207)||$ (8,592)||$ (19,852)||$ (22,527)|
|Basic and diluted loss per common share:|
|Basic||$ (8,190)||$ (8,579)||$ (19,814)||$ (22,503)|
|Shares used in computing net loss per common share:|
|Net loss per common share:|
|Basic||$ (0.16)||$ (0.18)||$ (0.38)||$ (0.48)|
|Diluted||$ (0.18)||$ (0.20)||$ (0.38)||$ (0.48)|
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717