Sunesis Pharmaceuticals Reports Second Quarter 2012 Financial Results and Highlights
SOUTH SAN FRANCISCO, Calif.,
"Next month, the independent Data and Safety Monitoring Board will conduct, in its single pre-planned interim analysis, the first efficacy review of the Phase 3 VALOR trial in acute myeloid leukemia," said Daniel Swisher, Chief Executive Officer of Sunesis. "The DSMB will examine pre-specified unblinded efficacy and safety data sets and decide whether to stop the study early for efficacy or futility, continue the study as planned or implement a one-time sample size adjustment of 225 additional evaluable patients. This important milestone will determine timing of the final outcome of this pivotal study and enable our plans for future regulatory filings and commercialization of vosaroxin."
Mr. Swisher added: "I continue to be pleased with the execution of the VALOR trial. The trial has now enrolled 391 patients, a figure that reflects broad investigator support across our more than 110 clinical sites, and underlines vosaroxin's potential to change the standard of care in this disease. We have also seen progress in our kinase inhibitor collaborations during the quarter. These collaborations allow us to leverage the resources of two leading biopharmaceutical companies,
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.
$1.5 MillionPayment From Biogen Idec Related to Kinase Inhibitor Program. In June, Sunesis received a $1.5 millionpayment 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 Commissiongranted 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 OncologyAnnual 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 ResearchAnnual 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 millionas of June 30, 2012, as compared to $44.1 millionas of December 31, 2011.
- Total revenue was
$1.5 millionfor the three and six months ended June 30, 2012, as compared to nil and $4.0 millionfor the same periods in 2011. Revenue in the 2012 periods was due to the receipt of a payment of $1.5 millionin June 2012for 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 millionfrom 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 millionand $14.7 millionfor the three and six months ended June 30, 2012, as compared to $6.0 millionand $10.0 millionfor 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, 2012were $2.2 millionand $4.4 million, as compared to $2.0 millionand $4.0 millionfor 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 millionfor the six months ended June 30, 2012, as compared to net other income of $3.6 millionfor the same period in 2011. Net other expense for the 2012 period was primarily comprised of non-cash expenses of $4.1 millionfor the revaluation of the warrants issued in the underwritten offering completed in October 2010to their fair value as of June 30, 2012. Net other income in the 2011 period included a credit of $3.2 millionfor a similar revaluation of these warrants.
- Sunesis reported a net loss of
$8.6 millionand $22.5 millionfor the three and six months ended June 30, 2012, as compared to net losses of $8.2 millionand $6.4 millionfor the same periods in 2011.
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 is expected to enroll 450 evaluable patients at more than 110 leading sites in the U.S., Canada, Europe, Australia and New Zealand. The VALOR trial is currently enrolling patients, who are randomized one to one to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. Additionally, the VALOR trial employs an innovative, adaptive trial design that allows for a one-time sample size adjustment by the Data and Safety Monitoring Board (DSMB) at the interim analysis to maintain adequate power across a broader range of survival outcomes. The trial's primary endpoint is overall survival. For more information on the VALOR trial, please visit www.valortrial.com.
The VALOR logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8774
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.
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 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
SUNESIS and the logo are trademarks of
|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
|Six months ended|
|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 Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717