Full Press Release Details
Sunesis Pharmaceuticals Reports Third Quarter 2010 Financial Results
FRANCISCO, Calif., (October 28, 2010) Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today reported financial results for the third quarter ended September 30, 2010. Net loss was $5.1 million for the third quarter of 2010 and $14.5
million for the nine months ended September 30, 2010. As of September 30, 2010, cash, cash equivalents and marketable securities totaled $40.8 million, with no debt outstanding. On October 6, 2010, Sunesis closed an underwritten
offering for gross proceeds of $15.5 million.
Sunesis has recently achieved several corporate milestones, said Daniel Swisher,
Chief Executive Officer of Sunesis. We are on track to enroll the first patient in the VALOR trial in the fourth quarter of this year. With over $55 million in cash following our October offering, Sunesis believes that it now has the resources
available and accessible to fund the VALOR trial until its planned unblinding in mid-2013.
Third Quarter and Recent Highlights
Financial Highlights
Sunesis anticipates initiating VALOR, a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory
AML, in the fourth quarter of 2010. The trial is designed to evaluate approximately 450 patients, multi-nationally, including leading sites in the U.S. and Europe. Patients will be randomized one to one to receive either voreloxin 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 Safety
Monitoring Board at the interim analysis to ensure adequate power across a broader range of clinically meaningful and statistically significant survival outcomes. The study s primary endpoint is overall survival.
About Vosaroxin (formerly voreloxin)
Vosaroxin, formerly known as voreloxin, is a first-in-class anticancer 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. Sunesis plans to initiate the VALOR trial, a multinational,
randomized, double-blind, placebo-controlled, pivotal Phase 3 clinical trial of vosaroxin in combination with cytarabine in a relapsed/refractory AML patient population, in the fourth quarter of 2010.
About Acute Myeloid Leukemia
rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates that 12,330 new cases of AML will be diagnosed and approximately 9,000 deaths
from AML will occur in the U.S. in 2010. 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
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.
This press release contains
forward-looking statements, including without limitation statements related to Sunesis plans to initiate a pivotal Phase 3 clinical trial of vosaroxin in the fourth quarter of this year, Sunesis belief as to the sufficiency of its
available and accessible cash resources to fund the VALOR trial until its planned unblinding in mid-2013 and the completion of the European patent validation process for vosaroxin. Words such as believe, accessible, on
track, could, plan, 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 ability to raise the capital that it believes to be accessible and is required to fund the VALOR trial until its planned unblinding in mid-2013, risks that the costs of the Phase 3 VALOR trial could exceed
Sunesis current estimates and that Sunesis may be required to expand the number of patients included in the trial based on the pre-specified interim analysis of data from the trial, each of which would require Sunesis to raise more capital
prior to the unblinding of the VALOR trial than the amount currently anticipated to be required, risks related to Sunesis need for substantial additional funding to complete the development and commercialization of vosaroxin, the risk that
unfavorable economic and market conditions may make it more difficult and costly to raise additional capital, the risk that the VALOR trial may not be initiated on the anticipated timeline and 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 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 June 30, 2010, Sunesis final prospectus supplement filed with the Securities and Exchange Commission pursuant to Rule 424(b)(5) under the Securities Act of 1933, as amended, on
October 1, 2010 and Sunesis other filings with the Securities and Exchange Commission, including Sunesis Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, when available. 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 and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2010 | December 31, 2009 | |||||||
| (Unaudited) | (Note 1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 14,140,109 | $ | 4,258,715 | ||||
| Marketable securities | 26,653,325 | |||||||
| Prepaids and other current assets | 2,025,721 | 583,030 | ||||||
| Total current assets | 42,819,155 | 4,841,745 | ||||||
| Property and equipment, net | 98,480 | 263,111 | ||||||
| Deposits and other assets | 59,974 | 64,425 | ||||||
| Total assets | $ | 42,977,609 | $ | 5,169,281 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 308,163 | $ | 360,300 | ||||
| Accrued clinical expense | 1,430,072 | 1,129,226 | ||||||
| Accrued compensation | 599,375 | 728,744 | ||||||
| Other accrued liabilities | 1,154,847 | 761,476 | ||||||
| Current portion of deferred rent | 25,051 | 27,943 | ||||||
| Deferred revenue | 27,083 | |||||||
| Total current liabilities | 3,517,508 | 3,034,772 | ||||||
| Non-current portion of deferred rent | 54,789 | 74,105 | ||||||
| Commitments | ||||||||
| Stockholders equity: | ||||||||
| Convertible preferred stock | 60,004,986 | |||||||
| Common stock | 22,192 | 3,590 | ||||||
| Additional paid-in capital | 410,308,771 | 298,469,584 | ||||||
| Accumulated other comprehensive income | 7,768 | |||||||
| Accumulated deficit | (370,933,419 | ) | (356,417,756 | ) | ||||
| Total stockholders equity | 39,405,312 | 2,060,404 | ||||||
| Total liabilities and stockholders equity | $ | 42,977,609 | $ | 5,169,281 |
Note 1: The condensed consolidated balance sheet as of December 31, 2009 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, 2009.
PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration revenue | $ | $ | 12,500 | $ | 27,083 | $ | 1,537,500 | |||||||||
| License and other revenue | 2,211,547 | |||||||||||||||
| Total revenues | 12,500 | 27,083 | 3,749,047 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,478,656 | 3,355,977 | 9,559,770 | 11,068,814 | ||||||||||||
| General and administrative | 1,804,173 | 1,533,367 | 5,219,708 | 5,883,283 | ||||||||||||
| Restructuring charges | 70,375 | 1,933,767 | ||||||||||||||
| Total operating expenses | 5,282,829 | 4,959,719 | 14,779,478 | 18,885,864 | ||||||||||||
| Loss from operations | (5,282,829 | ) | (4,947,219 | ) | (14,752,395 | ) | (15,136,817 | ) | ||||||||
| Other income (expense), net | 198,795 | (1,855 | ) | 236,732 | (21,054,157 | ) | ||||||||||
| Net loss | (5,084,034 | ) | (4,949,074 | ) | (14,515,663 | ) | (36,190,974 | ) | ||||||||
| Deemed distribution to preferred stockholders | (26,375,000 | ) | ||||||||||||||
| Loss attributable to common stockholders | $ | (5,084,034 | ) | $ | (4,949,074 | ) | $ | (14,515,663 | ) | $ | (62,565,974 | ) | ||||
| Basic and diluted loss attributable to common stockholders per common share | $ | (0.02 | ) | $ | (0.14 | ) | $ | (0.13 | ) | $ | (1.82 | ) | ||||
| Shares used in computing basic and diluted loss attributable to common stockholders per common share | 221,819,920 | 34,419,185 | 110,704,800 | 34,413,977 |