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SOUTH SAN FRANCISCO, Calif., July 29, 2016 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported financial results for the second quarter ended June 30, 2016. Loss from operations for the three months ended June 30, 2016 was $10.0 million. As of June 30, 2016, cash, cash equivalents and marketable securities totaled $33.1 million.
“During the second quarter, we strengthened the foundation of our oncology pipeline through the advancement of our vosaroxin program and lead proprietary BTK kinase inhibitor, SNS-062. Achievement of upcoming milestones from both these programs we believe will unlock significant value for the company,” said Daniel Swisher, Chief Executive Officer of Sunesis
“We are progressing our regulatory efforts to bring vosaroxin to market in Europe as a treatment for relapsed/refractory AML, and in parallel are maintaining an active dialogue with potential European collaborators toward the goal of supporting a market launch in 2017.” Mr. Swisher continued: “As for SNS-062, our differentiated, non-covalent BTK-inhibitor, we look forward to presenting results from our Phase 1A dose escalation study in healthy volunteers at the upcoming International Conference on New Concepts in B-Cell Malignancies in September. We are actively finalizing our protocol with investigator input to begin a Phase 1B/2 study in patients with B-cell malignancies around year-end.”
Second Quarter 2016 and Recent Highlights
Conference Call Information
Sunesis will host an update conference call today, July 29th at 11:00 a.m. Eastern Time. The call can be accessed by dialing (877) 771-6242 (U.S. and Canada) or (440) 996-5676 (international) and entering passcode 48017419. 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 company’s website for two weeks.
About QINPREZO™ (vosaroxin)
QINPREZO™ (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that 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 AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.
Vosaroxin’s Marketing Authorization Application for relapsed refractory AML is currently under review by the European Medicines Agency, and a regulatory decision regarding approval is expected in 2017.
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.
SNS-062 is a novel, second-generation BTK inhibitor, a class of kinase inhibitors that selectively inhibits the enzyme Bruton's tyrosine kinase (BTK). This target mediates signaling through the B-cell receptor, which is critical for adhesion, migration, proliferation and survival of normal and malignant B-lineage lymphoid cells. Unlike other drugs in its class, SNS-062 has a distinct kinase selectivity profile and binds non-covalently to the BTK enzyme, potentially providing an opportunity to address the leading resistance mechanism, a mutation in the enzyme’s binding site required for covalent binding. In preclinical studies, SNS-062 demonstrated potent activity against Cys-481S mutated B-cell malignancies, and is currently being studied in healthy subjects in a Phase 1A, randomized, double-blind, placebo-controlled dose-ranging study to investigate the drug’s safety, pharmacokinetics, and pharmacodynamics. With a successful study outcome, SNS-062 is expected to proceed to a Phase 1B/2 study in patients with B-cell malignancies around year end 2016.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to improving the lives of people with cancer. Currently, the company is focused on pursuing regulatory approval in Europe for its lead product candidate, vosaroxin, for the treatment of relapsed or refractory acute myeloid leukemia in patients aged 60 and older, as well as advancing its novel kinase-inhibitor pipeline, which includes its proprietary non-covalent BTK-inhibitor, SNS-062.
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 Sunesis' corporate objectives, including the anticipated progress and potential approval of vosaroxin by the EMA, timing of potential market launch in Europe for vosaroxin, and further clinical development of vosaroxin and SNS-062. Words such as “believe,” “goal,” “look forward,” "potential," "will" 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, the risk that Sunesis may not be able to receive regulatory approval of vosaroxin in the U.S. or Europe, that Sunesis' development activities for vosaroxin could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin or other product candidates, including its pipeline of kinase inhibitors, 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, risks related to the conduct of Sunesis' clinical trials, risks related to Sunesis' need for substantial additional funding to complete the development and commercialization of vosaroxin and other product candidates, and 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 and other product candidates. 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, 2015, Sunesis’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, when available, and Sunesis' other filings with the Securities and Exchange Commission. 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.|
|CONSOLIDATED BALANCE SHEETS|
|June 30,||December 31,|
|Cash and cash equivalents||$||9,447||$||26,886|
|Prepaids and other current assets||831||558|
|Total current assets||33,952||46,988|
|Property and equipment, net||8||14|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||2,006||1,954|
|Other accrued liabilities||1,858||2,711|
|Current portion of deferred revenue||1,831||2,441|
|Current portion of notes payable||833||7,834|
|Total current liabilities||10,400||18,999|
|Non-current portion of deferred revenue||-||610|
|Non-current other accrued liabilities||56|
|Non-current portion of notes payable||13,444||-|
|Additional paid-in capital||573,496||570,309|
|Accumulated other comprehensive income (loss)||1||(11||)|
|Total stockholders’ equity||10,060||27,393|
|Total liabilities and stockholders’ equity||$||33,960||$||47,002|
|Note 1: The consolidated balance sheet as of December 31, 2015 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2015.|
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended|
|Six months ended|
|License and other revenue||$||610||$||854||$||1,250||$||1,708|
|Research and development||6,606||6,302||12,815||10,814|
|General and administrative||3,997||5,175||8,292||10,286|
|Total operating expenses||10,603||11,477||21,107||21,100|
|Loss from operations||(9,993||)||(10,623||)||(19,857||)||(19,392||)|
|Other income (expense), net||23||1,907||99||1,787|
|Unrealized gain (loss) on available-for-sale securities||(1||)||-||12||2|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted loss per common share|
|Basic and diluted loss per common share|
|Note 2: The consolidated statement of operations and comprehensive loss for the year ended December 31, 2015 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, 2015.|
Investor and Media Inquiries: David Pitts Argot Partners 212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc. 650-266-3717NEXT ARTICLE
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