Full Press Release Details
Sunesis Pharmaceuticals Reports Second Quarter 2010 Financial Results
SOUTH SAN FRANCISCO, Calif., (August 12, 2010) Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today reported financial results for the second
quarter ended June 30, 2010. Net loss was $4.8 million for the second quarter of 2010. For the first half of 2010, net loss was $9.4 million. As of June 30, 2010, Sunesis had cash and cash equivalents of $49.3 million.
The second quarter was an important period for Sunesis, as we reached key clinical, regulatory and financial milestones leading up to the launch of
our planned Phase 3 pivotal trial of vosaroxin in acute myeloid leukemia in the second half of this year, said Daniel Swisher, Chief Executive Officer of Sunesis. During the period, important Phase 2 data on vosaroxin s activity and
safety in AML and ovarian cancer were presented at the ASCO annual meeting, we received scientific advice from the EMA on our proposed development plans for vosaroxin, and we strengthened our balance sheet. We continue to make progress toward the
initiation of our pivotal Phase 3 trial, known as the VALOR trial, and are working toward ensuring its successful launch and execution.
Data from the fully-enrolled Phase 2 trial of vosaraxin in combination with cytabarine in relapsed/refractory AML
demonstrated a meaningful improvement in overall survival relative to literature-based values reported for current treatment standards of care, including cytarabine-based regimens. Among evaluable first relapse (n=36) and primary refractory patients
(n=33) treated at doses of 80 to 90 mg/m2 of vosaroxin on
days one and four, in addition to cytarabine on days one through five, median overall survival is 7.1 months. Of these patients, over 80% were either primary refractory or had an initial first remission (CR1) of less than 12 months; 20 patients
remain in survival follow-up and are beyond the median. The overall remission rate was 29% with the vast majority being complete remissions (17 of 20). All-cause mortality among these patients was 3% at 30 days and 9% at 60 days. This study forms
the basis for the planned pivotal Phase 3 VALOR trial.
The Company also presented promising data from its
fully-enrolled Phase 2 trial (REVEAL-1) of single-agent vosaroxin in previously untreated, elderly AML patients. The REVEAL-1 trial includes three dosing schedules. As previously reported, Schedule C (72
mg/m2 of vosaroxin on days one and four) is the
recommended dose regimen for further study. For Schedule C (n=29), median overall survival is 7.7 months and one year survival is 38%, with 33% of patients remaining in follow-up. Response rate (CR and CRp) was 38%; 30- and 60-day all-cause
mortality were 7% and 17%, respectively.
Final data from the Company s Phase 2 trial of vosaroxin in
platinum-resistant ovarian cancer demonstrated encouraging, durable anti-tumor activity across all three dose cohorts. Cohort B (60
mg/m2 of vosaroxin given every four weeks) is the
recommended dose regimen for further study. For Cohort B (n=37), 54% of patients achieved disease control including 11% objective response rate (ORR, 1 CR and 3 PRs), low incidence of grade 3 or higher febrile neutropenia (5%) and a long
progression-free survival (PFS). Median PFS was 85 days.
Financial Highlights
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 second half of this year.
About Acute Myeloid Leukemia
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, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional
information on Sunesis Pharmaceuticals, 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 second half of this year, the safety and efficacy of vosaroxin and the completion of the patent
validation process. Words such as evaluate, planned, 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 fully finance the planned vosaroxin pivotal trial, the risk that Sunesis development activities for vosaroxin could be 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 March 31, 2010 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 and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
SUNESIS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2010 | December 31, 2009 | |||||||
| (Unaudited) | (Note 1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 49,297,623 | $ | 4,258,715 | ||||
| Prepaids and other current assets | 318,397 | 583,030 | ||||||
| Total current assets | 49,616,020 | 4,841,745 | ||||||
| Property and equipment, net | 127,246 | 263,111 | ||||||
| Deposits and other assets | 98,846 | 64,425 | ||||||
| Total assets | $ | 49,842,112 | $ | 5,169,281 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 766,824 | $ | 360,300 | ||||
| Accrued clinical expense | 976,540 | 1,129,226 | ||||||
| Accrued compensation | 1,162,198 | 728,744 | ||||||
| Other accrued liabilities | 2,597,470 | 761,476 | ||||||
| Current portion of deferred rent | 26,015 | 27,943 | ||||||
| Deferred revenue | 27,083 | |||||||
| Total current liabilities | 5,529,047 | 3,034,772 | ||||||
| Non-current portion of deferred rent | 61,741 | 74,105 | ||||||
| Commitments | ||||||||
| Stockholders equity: | ||||||||
| Convertible preferred stock | 60,004,986 | |||||||
| Common stock | 22,118 | 3,590 | ||||||
| Additional paid-in capital | 410,078,591 | 298,469,584 | ||||||
| Accumulated deficit | (365,849,385 | ) | (356,417,756 | ) | ||||
| Total stockholders equity | 44,251,324 | 2,060,404 | ||||||
| Total liabilities and stockholders equity | $ | 49,842,112 | $ | 5,169,281 |
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.
SUNESIS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2010 | 2009 | 2010 | 2009 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration revenue | $ | 14,583 | $ | 1,512,500 | $ | 27,083 | $ | 1,525,000 | ||||||||
| License and other revenue | 2,000,000 | 2,211,547 | ||||||||||||||
| Total revenues | 14,583 | 3,512,500 | 27,083 | 3,736,547 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,971,273 | 3,448,685 | 6,081,114 | 7,712,836 | ||||||||||||
| General and administrative | 1,861,623 | 1,994,903 | 3,415,535 | 4,349,916 | ||||||||||||
| Restructuring charges | 532 | 1,863,393 | ||||||||||||||
| Total operating expenses | 4,832,896 | 5,444,120 | 9,496,649 | 13,926,145 | ||||||||||||
| Loss from operations | (4,818,313 | ) | (1,931,620 | ) | (9,469,566 | ) | (10,189,598 | ) | ||||||||
| Other income (expense), net | 34,366 | (20,946,844 | ) | 37,937 | (21,052,301 | ) | ||||||||||
| Net loss | (4,783,947 | ) | (22,878,464 | ) | (9,431,629 | ) | (31,241,899 | ) | ||||||||
| Deemed distribution to preferred stockholders | (26,375,000 | ) | (26,375,000 | ) | ||||||||||||
| Loss attributable to common stockholders | $ | (4,783,947 | ) | $ | (49,253,464 | ) | $ | (9,431,629 | ) | $ | (57,616,899 | ) | ||||
| Basic and diluted loss attributable to common stockholders per common share | $ | (0.07 | ) | $ | (1.43 | ) | $ | (0.17 | ) | $ | (1.67 | ) | ||||
| Shares used in computing basic and diluted loss attributable to common stockholders per common share | 65,473,222 | 34,412,870 | 54,226,396 | 34,411,327 |