Sunesis Pharmaceuticals Reports Third Quarter 2011 Financial Results
Sunesis Pharmaceuticals, Inc.Logo Image: VALOR Logo
"Sunesis' recently announced tranched loan facility provides us with capital and access to capital which is minimally dilutive and substantially funds the company through to completion of the Phase 3 VALOR trial, regardless of outcome at the trial's interim analysis," said
Third Quarter 2011 and Recent Highlights
$25.0 milliontranched loan facility. In October, Sunesis announced that it had entered into a $25.0 milliontranched loan facility led by Oxford Finance and partnered with Silicon Valley Bankand Horizon Technology Finance Corporation. Under the terms of the loan agreement, Sunesis received $10.0 millionat closing, with the remaining $15.0 millionavailable to draw at Sunesis' discretion following the planned interim analysis of the VALOR trial by an independent Data and Safety Monitoring Board (DSMB), which is expected in mid-2012, provided the trial continues or is stopped early for efficacy and provided further that Sunesis is compliant with the terms and conditions of the related loan agreement. Updated leukemia-free survival, increased to 25 months. At the company's analyst meeting in October, Sunesis announced leukemia-free survival (LFS) data from its Phase 2 cytarabine/vosaroxin trial in first relapsed and primary refractory acute myeloid leukemia (AML). The LFS was updated to 25 months, an increase from the previously reported 14.5 months. Initiated Phase 1 Trial of MLN2480 initiated in advanced solid tumors. In September, Sunesis announced the initiation of a Phase 1 clinical trial of MLN2480, an oral, investigative drug selective for pan-Raf kinase inhibition, which is being studied in patients with relapsed or refractory solid tumors. The trial is being sponsored by Millennium Pharmaceuticals, Inc., which is developing MLN2480 in oncology in collaboration with Sunesis. Issued important U.S. patent covering vosaroxin use in leukemia.In August, Sunesis announced that it had been granted a patent by the U.S. Patent and Trademark Office (USPTO), covering methods of use for vosaroxin at various dose ranges and schedules for the treatment of leukemia, including the dose and schedule under evaluation in Sunesis' pivotal, Phase 3 VALOR trial. The patent provides coverage through 2026, and corresponding applications are pending in other major markets, including Europe, Japan, Australiaand Canada. Announced publication of Phase 1b data of vosaroxin in relapsed or refractory leukemia. In July, Sunesis announced the publication of data from a Phase 1b multi-center trial of vosaroxin in relapsed or refractory leukemia in the July 2011issue of Leukemia. The results show that single-agent vosaroxin was well-tolerated, with a potent anti-leukemic effect in patients who had received multiple prior therapies. The Phase 1b data, along with results from Phase 2 studies of vosaroxin used alone and in combination with cytarabine in the treatment of AML, support the currently-enrolling VALOR trial. The Leukemia article and full, published data set are available online at: http://www.nature.com/leu/journal/vaop/ncurrent/full/leu2011157a.html.
Cash, cash equivalents and marketable securities totaled
$41.8 millionas of September 30, 2011, compared to $53.4 millionas of December 31, 2010. Including the net loan proceeds received in October, the September 30, 2011balance would have been $51.5 million. Total revenue for the three and nine months ended September 30, 2011were $1.0 millionand $5.0 million, as compared to nil and $27,000for the same periods in 2010. Revenue in the third quarter of 2011 related to the recognition of deferred revenue from the sale of certain intellectual property rights following the repayment by SARcode of three promissory notes originally issued to Sunesis in March 2006. Revenue for the nine month period in 2011 also included the $4.0 millionupfront payment from Millennium received in April 2011. Research and development expenses increased to $6.2 millionand $16.2 millionfor the three and nine months ended September 30, 2011, as compared to $3.5 millionand $9.6 millionfor the same periods in 2010. The increases in 2011 were primarily due to increases in clinical expenses incurred as a result of the ramp-up of the VALOR trial, as well as increased drug manufacturing activities and personnel costs. General and administrative expenses for the three and nine months ended September 30, 2011were $2.2 millionand $6.1 million, as compared to $1.8 millionand $5.2 millionfor the same periods in 2010. The increases in 2011 were primarily due to higher legal, marketing and personnel expenses. Net other income was $2.4 millionand $6.0 millionfor the three and nine months ended September 30, 2011, as compared to $0.2 millionfor each of the same periods in 2010. Net other income for the three and nine months ended September 30, 2011was primarily comprised of non-cash credits of $2.5 millionand $5.7 million, respectively, for the revaluation of warrants issued in the October 2010offering to their fair value as of September 30, 2011. Sunesis reported a net loss of $5.0 millionand $11.4 millionfor the three and nine months ended September 30, 2011, as compared to a net loss of $5.1 millionand $14.5 millionfor the same periods in 2010.
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 approximately 100 leading sites in the U.S.,
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.
About Acute Myeloid Leukemia
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 www.sunesis.com.
This press release contains forward-looking statements, including statements related to the sufficiency of Sunesis' cash resources through to the completion of the VALOR trial, the occurrence and timing of the DSMB interim analysis, the availability of the second tranche under the loan facility with
SUNESIS and the logo are trademarks of
SUNESIS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) September 30, December 31, 2011 2010 ASSETS (Unaudited) (Note 1) Current assets: Cash and cash equivalents $ 11,894 $ 14,223 Marketable securities 29,869 39,173 Prepaids and other current assets 1,770 1,286 Total current assets 43,533 54,682 Property and equipment, net 82 116 Deposits and other assets 60 60 Total assets $ 43,675 $ 54,858 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 327 $ 416 Accrued clinical expense 2,762 1,574 Accrued compensation 1,019 1,013 Other accrued liabilities 1,281 1,406 Warrant liability 2,453 8,154 Total current liabilities 7,842 12,563 Non-current portion of deferred rent 22 48 Commitments Stockholders' equity: Common stock 5 5 Additional paid-in capital 428,192 423,262 Accumulated other comprehensive income (loss) 20 (15) Accumulated deficit (392,406) (381,005) Total stockholders' equity 35,811 42,247 Total liabilities and stockholders' equity $ 43,675 $ 54,858 Note 1: The condensed consolidated balance sheet as of December 31, 2010has 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, 2010.
SUNESIS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) Three months ended September 30,Nine months ended
September 30, 2011 2010 2011 2010 (Unaudited) (Unaudited) Revenue: Collaboration revenue $ -- $ -- $ -- $ 27 License and other revenue 1,000 -- 5,000 -- Total revenues 1,000 -- 5,000 27 Operating expenses: Research and development 6,217 3,479 16,237 9,560 General and administrative 2,155 1,804 6,144 5,220 Total operating expenses 8,372 5,283 22,381 14,780 Loss from operations (7,372) (5,283) (17,381) (14,753) Other income (expense), net 2,358 199 5,980 237 Net loss $ (5,014) $ (5,084) $ (11,401) $ (14,516) Basic and diluted net loss per common share $ (0.11) $ (0.14) $ (0.25) $ (0.79) Shares used in computing basic and diluted net loss per common share 46,714 36,970 46,304 18,451
CONTACT: Investor and Media Inquiries:
David Pitts Argot Partners212-600-1902 Eric Bjerkholt Sunesis Pharmaceuticals Inc.650-266-3717