Full Press Release Details
Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2009
SOUTH SAN FRANCISCO, CA, March 30, 2010 Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS)
today reported financial results for the fourth quarter and fiscal year ended December 31, 2009.
Net loss was $4.0 million for the
fourth quarter of 2009 and $40.2 million for the year ended December 31, 2009. Net loss for the year included non-cash charges of $21.0 million related to the accounting for a tranched private placement, for which the initial $10.0 million was
closed in April 2009 and the second $5.0 million was closed in October 2009. Loss from operations for 2009, which does not include these charges, was $19.1 million. As of December 31, 2009, cash, cash equivalents and marketable securities
totaled $4.3 million, with no debt outstanding.
The Sunesis team realized a number of important goals for our lead development program
in 2009, culminating in voreloxin s advancement to Phase 3. This first-in-class anticancer compound is among the most promising product candidates for acute myeloid leukemia, said Daniel Swisher, Chief Executive Officer of Sunesis.
Voreloxin has a clear path to registration in AML. This randomized, placebo-controlled Phase 3 trial of voreloxin in combination with cytarabine, anticipating launch in the second half of 2010, is designed to demonstrate a meaningful
improvement in overall survival in patients with relapsed or refractory AML. These patients represent a significant segment of the AML population with no appreciable advance in therapy in over thirty years.
About the Pivotal Phase 3 Trial
Following formal End-of-Phase 2 meetings with the U.S. Food and Drug Administration in January 2010, Sunesis announced plans to conduct a randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or primary
refractory AML. The trial is designed to evaluate approximately 450 patients, multi-nationally, including leading sites in the U.S. and Europe. Patients are expected to be randomized one to one to receive either voreloxin (90 mg/m2) on days one and four in combination with cytarabine (1
g/m2) daily for five days or placebo in combination with
cytarabine. The study s primary endpoint is overall survival. Sunesis anticipates initiating this trial in the second half of 2010. As part of the preparation for this pivotal study, the Company is obtaining the European Medicines Agency s
scientific advice. Management is currently in the process of evaluating alternatives for funding the voreloxin development program.
Also at ASH, the Company presented interim clinical data from the Phase 2 trial of single-agent voreloxin in newly diagnosed elderly AML
patients unlikely to benefit from standard induction chemotherapy (the REVEAL-1 trial). Based on trial results, Schedule C (72 mg/m2 on days one and four) has been determined to be the recommended dose regimen for future studies with single agent
voreloxin in frontline elderly AML. For Schedule C, response rates (CR and complete remissions without full platelet recovery, or CRp) are 38%, most of which are CRs; 30- and 60-day all-cause mortality are 7% and 17%, respectively; and preliminary
median overall survival is 7.3 months.
Financial Highlights
Voreloxin is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the
treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is currently being evaluated in a fully enrolled single agent Phase
2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a fully enrolled Phase 1b/2 clinical trial combining voreloxin with cytarabine for the
treatment of patients with relapsed/refractory AML. A Phase 2 single agent trial in platinum-resistant ovarian cancer has also completed enrollment. Sunesis anticipates initiating a Phase 3 trial
of voreloxin in AML in the second half of 2010.
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. The National
Cancer Institute estimated that nearly 13,000 new cases of AML were diagnosed and approximately 9,000 deaths from AML occurred in the U.S. in 2009. Additionally, it is estimated that prevalence of AML is approximately 25,000 in the U.S. AML is
generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors
typically die within one year, resulting in an acute need for new treatment options for these patients.
About Sunesis Pharmaceuticals
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, voreloxin, 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 logo are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including without limitation statements related to the timing and our ability to
arrange sufficient funding to finance the voreloxin pivotal trial and continue as a going concern, the sufficiency of our capital, the planned commencement of a pivotal trial of voreloxin and its timing, the financial benefits provided by the Cantor
facility and the benefits of voreloxin in combination with cytarabine, azacitidine, decitabine and clofarabine. Words such as planning, planned, may, 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, risks related to Sunesis need for additional funding to finance the voreloxin pivotal trial
and to continue as a going concern, the risk that Sunesis drug development activities for voreloxin could be halted or significantly delayed for various reasons, the risk that Sunesis clinical trials for voreloxin may not demonstrate
safety or efficacy or lead to regulatory approval, the risk that preliminary data and trends may not be predictive of future data or results, the risk that Sunesis nonclinical studies and clinical trials 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 voreloxin, and the risk that Sunesis proprietary rights may not adequately protect voreloxin. These and
other risk factors are discussed under Risk Factors and elsewhere in Sunesis Quarterly Report on Form 10-Q for the quarter ended September 30, 2009 and 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 the company s 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
| December 31, 2009 | December 31, 2008 | |||||||
| (Note 1) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,258,715 | $ | 6,296,942 | ||||
| Marketable securities | 4,321,844 | |||||||
| Prepaids and other current assets | 583,030 | 934,429 | ||||||
| Total current assets | 4,841,745 | 11,553,215 | ||||||
| Property and equipment, net | 263,111 | 612,241 | ||||||
| Assets held-for-sale | 470,547 | |||||||
| Deposits and other assets | 64,425 | 147,826 | ||||||
| Total assets | $ | 5,169,281 | $ | 12,783,829 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 360,300 | $ | 790,546 | ||||
| Accrued clinical expense | 1,129,226 | 1,865,773 | ||||||
| Accrued compensation | 728,744 | 537,215 | ||||||
| Accrued restructuring charges | 11,982 | 191,170 | ||||||
| Other accrued liabilities | 749,494 | 1,360,434 | ||||||
| Current portion of deferred rent | 27,943 | 1,409,513 | ||||||
| Deferred revenue | 27,083 | 27,083 | ||||||
| Total current liabilities | 3,034,772 | 6,181,734 | ||||||
| Non-current portion of deferred rent | 74,105 | 110,919 | ||||||
| Commitments | ||||||||
| Stockholders equity: | ||||||||
| Convertible preferred stock | 60,004,986 | |||||||
| Common stock | 3,590 | 3,441 | ||||||
| Additional paid-in capital | 298,469,584 | 322,671,604 | ||||||
| Accumulated other comprehensive income | 7,841 | |||||||
| Accumulated deficit | (356,417,756 | ) | (316,191,710 | ) | ||||
| Total stockholders equity | 2,060,404 | 6,491,176 | ||||||
| Total liabilities and stockholders equity | $ | 5,169,281 | $ | 12,783,829 |
Note 1: The consolidated balance sheet as of December 31, 2008 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, 2008.
SUNESIS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three months ended December 31, | Year ended December 31, | |||||||||||||||
| 2009 | 2008 | 2009 | 2008 | |||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration revenue related party | $ | $ | $ | 1,500,000 | $ | 4,310,551 | ||||||||||
| Collaboration revenue other | 12,500 | 12,500 | 50,000 | 606,789 | ||||||||||||
| License and other revenue | 2,211,547 | 500,000 | ||||||||||||||
| Total revenues | 12,500 | 12,500 | 3,761,547 | 5,417,340 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,178,045 | 4,617,239 | 13,246,859 | 26,285,294 | ||||||||||||
| General and administrative | 1,864,960 | 2,195,211 | 7,748,243 | 11,524,198 | ||||||||||||
| Restructuring charges | (18,451 | ) | 393,158 | 1,915,316 | 5,782,903 | |||||||||||
| Total operating expenses | 4,024,554 | 7,205,608 | 22,910,418 | 43,592,395 | ||||||||||||
| Loss from operations | (4,012,054 | ) | (7,193,108 | ) | (19,148,871 | ) | (38,175,055 | ) | ||||||||
| Interest income | 772 | 60,649 | 21,630 | 929,114 | ||||||||||||
| Interest expense | (139 | ) | (17,224 | ) | (1,188 | ) | (171,308 | ) | ||||||||
| Other income (expense), net | (23,651 | ) | 222,551 | (21,097,617 | ) | 231,622 | ||||||||||
| Net loss | (4,035,072 | ) | (6,927,132 | ) | (40,226,046 | ) | (37,185,627 | ) | ||||||||
| Deemed distribution to preferred stockholders | (1,188,400 | ) | (27,563,400 | ) | ||||||||||||
| Loss attributable to common stockholders | $ | (5,223,472 | ) | $ | (6,927,132 | ) | $ | (67,789,446 | ) | $ | (37,185,627 | ) | ||||
| Basic and diluted loss attributable to common stockholders per common share | $ | (0.15 | ) | $ | (0.20 | ) | $ | (1.97 | ) | $ | (1.08 | ) | ||||
| Shares used in computing basic and diluted loss attributable to common stockholders per common share | 34,678,757 | 34,404,578 | 34,480,716 | 34,387,177 |