Sunesis Pharmaceuticals Reports Third Quarter Financial Results and Recent Highlights
"The VALOR trial, which completed enrollment this past quarter, is the largest company-sponsored trial ever undertaken in relapsed/refractory AML," said
Mr. Swisher added: "Importantly, as VALOR nears completion, we continue to explore the potential of vosaroxin in additional patient settings and in novel combinations with leading treatment standards, through a variety of ongoing investigator sponsored trials."
Third Quarter 2013 and Recent Highlights
Continued strong execution of VALOR trial. In September, enrollment in the Sunesis Phase 3 VALOR trial was completed on schedule. VALOR is a pivotal, randomized, double-blind, placebo-controlled trial of vosaroxin plus cytarabine in first relapsed or refractory acute myeloid leukemia (AML). Unblinding of the VALOR trial is currently expected in the second quarter of 2014, after reaching 562 events and locking the final study database.
Announced successful completion of Phase 1b stage and initiation of Phase 2 cohort of
Announced initiation of U.S. investigator sponsored trial in MDS. In October, Sunesis announced the initiation of an investigator-sponsored trial of vosaroxin in patients with MDS who have previously failed treatment with hypomethylating agent-based therapy. This Phase 1/2 trial is designed to evaluate vosaroxin alone in adult patients with previously treated, intermediate-2 or high-risk MDS, and is being conducted at
LI-1 trial update. Enrollment of the first 50 patients in the combination arm of vosaroxin and low-dose cytarbine (LoDAC) in the Less Intensive 1 (LI-1) trial, a Phase 2/3 randomized, controlled trial evaluating novel treatment regimens in newly diagnosed elderly AML and high-risk MDS patients, is complete and the first interim evaluation of this treatment arm is expected to take place before year end. The LI-1 trial is being conducted under the direction of Professor
Cash and investments totaled
$45.5 millionas of September 30, 2013, as compared to $71.2 millionas of December 31, 2012. The decrease of $25.7 millionwas primarily due to $27.7 millionof cash used in operating activities and $5.0 millionof principal payments against notes payable, partially offset by $6.6 millionof net proceeds from sales of common stock through the at-the-market facility with Cantor Fitzgerald & Co.The notes payable had an outstanding balance of $20.0 millionas of September 30, 2013. Subsequent to quarter end, Sunesis raised an additional $4.5 million, net, through sales under the at-the-market facility, bringing pro-forma cash at quarter end to $50.0 million.
Total revenue was
$2.0 millionand $6.0 millionfor the three and nine months ended September 30, 2013, as compared to $0.3 millionand $1.8 millionfor 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 nine-month period in 2012 was primarily 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
$7.0 millionand $22.0 millionfor the three and nine months ended September 30, 2013, as compared to $6.9 millionand $21.6 millionduring the same periods in 2012. The increase between the comparable three month periods was primarily due to increased personnel costs offset by a decrease in drug manufacturing costs. The increase between the comparable nine month periods was primarily due to increased clinical trial expenses.
General and administrative expenses for the three and nine months ended
September 30, 2013were $2.8 millionand $8.1 million, as compared to $2.3 millionand $6.7 millionfor the same periods in 2012. The increases between the comparable periods were primarily due to higher professional service costs.
Interest expense was
$0.7 millionand $2.3 millionfor the three and nine months ended September 30, 2013, as compared to $0.4 millionand $1.0 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
$0.9 millionfor the three months ended September 30, 2013, as compared to net other expense of $8.1 millionfor the same period in 2012. Net other expense was $0.9 millionfor the nine months ended September 30, 2013, as compared to $12.4 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
$27.7 millionfor the nine months ended September 30, 2013, as compared to $1.4 millionfor the same period in 2012, which included $25.0 millionreceived from Royalty Pharma. Net cash used in the 2013 period resulted primarily from the net loss of $27.4 millionand changes in operating assets and liabilities of $4.5 million, partially offset by net adjustments for non-cash items of $4.2 million.
Sunesis reported a loss from operations of
$7.8 millionand $24.2 millionfor the three and nine months ended September 30, 2013, as compared to $8.9 millionand $26.5 millionfor the same periods in 2012. Net loss was $7.6 millionand $27.4 millionfor the three and nine months ended September 30, 2013as compared to $17.4 millionand $39.9 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 is being conducted 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 and Sunesis' other clinical programs discussed in this release. Words such as "believe," "continue," "estimate," "expect," "improve," "positive," "potential," "remain," 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|
|Cash and cash equivalents||$ 21,732||$ 14,940|
|Prepaids and other current assets||1,014||1,705|
|Total current assets||46,512||72,932|
|Property and equipment, net||27||43|
|Deposits and other assets||16||42|
|Total assets||$ 46,555||$ 73,017|
|LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)|
|Accounts payable||$ 1,459||$ 78|
|Accrued clinical expense||4,838||5,449|
|Other accrued liabilities||1,973||2,113|
|Current portion of deferred revenue||7,956||7,956|
|Current portion of notes payable||8,750||6,610|
|Total current liabilities||35,332||31,741|
|Non-current portion of deferred revenue||5,701||11,668|
|Non-current portion of notes payable||11,299||17,651|
|Stockholders' equity (deficit):|
|Additional paid-in capital||466,727||457,011|
|Accumulated other comprehensive income||9||38|
|Total stockholders' equity (deficit)||(5,777)||11,957|
|Total liabilities and stockholders' equity (deficit)||$ 46,555||$ 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
Nine months ended
|License and other revenue||$ 1,989||$ 265||$ 5,967||$ 1,765|
|Research and development||6,957||6,878||22,008||21,596|
|General and administrative||2,807||2,331||8,140||6,702|
|Total operating expenses||9,764||9,209||30,148||28,298|
|Loss from operations||(7,775)||(8,944)||(24,181)||(26,533)|
|Other income (expense), net||863||(8,067)||(946)||(12,350)|
|Unrealized gain (loss) on available-for-sale securities||9||2||(29)||(22)|
|Comprehensive loss||$ (7,598)||$ (17,394)||$ (27,450)||$ (39,921)|
|Basic and diluted loss per common share:|
|Basic||$ (7,607)||$ (17,396)||$ (27,421)||$ (39,899)|
|Shares used in computing net loss per common share:|
|Net loss per common share:|
|Basic||$ (0.15)||$ (0.37)||$ (0.53)||$ (0.85)|
|Diluted||$ (0.16)||$ (0.37)||$ (0.53)||$ (0.85)|
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717