Full Press Release Details
Sunesis Pharmaceuticals Reports Second Quarter 2014 Financial Results and Recent Highlights
VALOR Trial Reaches Prespecified Events for Unblinding
Sunesis to Host Conference Call Today at 11:00 AM Eastern Time
SOUTH SAN FRANCISCO, Calif., (August 5, 2014) Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today reported financial results for the quarter
ended June 30, 2014. Loss from operations for the three and six months ended June 30, 2014 was $11.6 million and $20.6 million, respectively. As of June 30, 2014, cash, cash equivalents and marketable securities totaled $58.5 million.
As we near unblinding of our pivotal, Phase 3 VALOR trial in first relapsed or refractory AML, an increasing focus of our resources is the
advancement of our QINPREZO regulatory, commercial and lifecycle management strategies, said Daniel Swisher, Chief Executive Officer of Sunesis. With the recently announced acceptance by the EMA of a Pediatric Investigation Plan,
our regulatory strategies in both Europe and the U.S. are now well defined. On the commercial front, we continue to make significant progress as we refine the key elements of a comprehensive U.S. commercial plan and build out a preeminent oncology
team with key hires.
Mr. Swisher added: Having now reached the prespecified number of events, we continue to expect unblinding of the
VALOR trial in the second half of 2014. Our progress with the QINPREZO program, together with our growing pipeline of novel and differentiated therapeutic programs and a strong balance sheet, position Sunesis to reach our goal of becoming a leading,
integrated oncology company.
Second Quarter 2014 and Recent Highlights
Financial Highlights
Conference Call Information
Sunesis will host an update
conference call today, August 5th at 11:00 a.m. Eastern Time. The call can be accessed by dialing (866) 515-2915 (U.S. and Canada) or (617) 399-5129 (international), and entering passcode 41527679. To access the live audio webcast, or
the subsequent archived recording, visit the Investors and Media - Calendar of Events section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company s website for two weeks.
VALOR is a Phase 3, randomized,
double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial enrolled 712 patients at more than 100 leading sites in the U.S., Canada, Europe, Australia, New Zealand and South Korea. Patients were
randomized in a ratio of 1:1 to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. The trial s primary endpoint is overall survival. For more information
on the VALOR trial, please visit www.valortrial.com.
About QINPREZO (vosaroxin)
QINPREZO 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.
Preclinical data demonstrate that QINPREZO both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European
Commission have granted orphan drug designation to QINPREZO for the treatment of AML. Additionally, QINPREZO has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine.
QINPREZO is an investigational drug that has not been approved for use in any jurisdiction.
The trademark QINPREZO has been conditionally accepted by the FDA and the EMA as the proprietary name for the
company s vosaroxin drug product candidate.
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American
Cancer Society estimates there will be approximately 18,860 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2014. Additionally, it is estimated that the prevalence of AML across major global markets (U.S., France, Germany,
Italy, Spain, United Kingdom and Japan) is over 50,000. 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
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, QINPREZO, in multiple indications to improve the lives of people with cancer.
For additional information on
Sunesis, please visit http://www.sunesis.com.
SUNESIS, QINPREZO and the related logos are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including statements related to Sunesis overall strategy, the design, conduct, progress, timing
and results of the VALOR trial and Sunesis other clinical trials and the commercial potential for QINPREZO (vosaroxin). Words such as anticipate, approximately, believe, continue,
could, estimate, expect, position, potential, 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 QINPREZO, risks related to whether outstanding warrants will be exercised
in the future, 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 QINPREZO, the risk that raising funds through lending arrangements
may restrict our operations or produce other adverse results, the risk that Sunesis development activities for QINPREZO could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis clinical studies for
QINPREZO 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, European Commission or other regulatory agencies, risks related to the conduct of Sunesis clinical trials, risks related to the manufacturing of QINPREZO and supply of the active pharmaceutical ingredients
required for the conduct of Sunesis clinical trials, the risk of third party opposition to granted patents related to QINPREZO, and the risk that Sunesis proprietary rights may not adequately protect QINPREZO. These and other risk
are discussed under Risk Factors and elsewhere in Sunesis Annual Report on Form 10-K for the year ended December 31, 2013, and Sunesis other filings with the
Securities and Exchange Commission, including Sunesis Quarterly Report on Form 10-Q for the quarter ended June 30, 2014, 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 Sunesis 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
| June 30, 2014 | December 31, 2013 | |||||||
| (Unaudited) | (Note 1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 26,761 | $ | 15,121 | ||||
| Marketable securities | 31,782 | 24,172 | ||||||
| Prepaids and other current assets | 1,133 | 1,199 | ||||||
| Total current assets | 59,676 | 40,492 | ||||||
| Property and equipment, net | 35 | 23 | ||||||
| Deposits and other assets | 2 | 10 | ||||||
| Total assets | $ | 59,713 | $ | 40,525 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 513 | $ | 953 | ||||
| Accrued clinical expense | 3,938 | 4,750 | ||||||
| Accrued compensation | 1,288 | 1,719 | ||||||
| Other accrued liabilities | 4,238 | 1,645 | ||||||
| Current portion of deferred revenue | 7,690 | 7,956 | ||||||
| Current portion of notes payable | 9,573 | 9,018 | ||||||
| Warrant liability | 12,400 | 7,931 | ||||||
| Total current liabilities | 39,640 | 33,972 | ||||||
| Non-current portion of deferred revenue | 3,712 | |||||||
| Non-current portion of notes payable | 4,234 | 9,025 | ||||||
| Commitments | ||||||||
| Stockholders equity (deficit): | ||||||||
| Common stock | 6 | 5 | ||||||
| Additional paid-in capital | 521,889 | 473,509 | ||||||
| Accumulated other comprehensive loss | (7 | ) | (3 | ) | ||||
| Accumulated deficit | (506,049 | ) | (479,695 | ) | ||||
| Total stockholders equity (deficit) | 15,839 | (6,184 | ) | |||||
| Total liabilities and stockholders equity (deficit) | $ | 59,713 | $ | 40,525 |
Note 1: The consolidated balance sheet as of December 31, 2013 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, 2013.
SUNESIS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(In thousands, except per share amounts)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenue: | ||||||||||||||||
| License and other revenue | $ | 1,989 | $ | 1,989 | $ | 3,984 | $ | 3,978 | ||||||||
| Total revenues | 1,989 | 1,989 | 3,984 | 3,978 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 7,206 | 7,674 | 14,758 | 15,051 | ||||||||||||
| General and administrative | 6,387 | 2,889 | 9,804 | 5,333 | ||||||||||||
| Total operating expenses | 13,593 | 10,563 | 24,562 | 20,384 | ||||||||||||
| Loss from operations | (11,604 | ) | (8,574 | ) | (20,578 | ) | (16,406 | ) | ||||||||
| Interest expense | (470 | ) | (768 | ) | (1,017 | ) | (1,599 | ) | ||||||||
| Other income (expense), net | 293 | 1,152 | (4,759 | ) | (1,809 | ) | ||||||||||
| Net loss | (11,781 | ) | (8,190 | ) | (26,354 | ) | (19,814 | ) | ||||||||
| Unrealized gain (loss) on available-for-sale securities | (11 | ) | (17 | ) | (4 | ) | (38 | ) | ||||||||
| Comprehensive loss | $ | (11,792 | ) | $ | (8,207 | ) | $ | (26,358 | ) | $ | (19,852 | ) | ||||
| Basic and diluted loss per common share: | ||||||||||||||||
| Net loss: | ||||||||||||||||
| Basic | $ | (11,781 | ) | $ | (8,190 | ) | $ | (26,354 | ) | $ | (19,814 | ) | ||||
| Diluted | $ | (12,114 | ) | $ | (9,336 | ) | $ | (26,354 | ) | $ | (19,814 | ) | ||||
| Shares used in computing net loss per common share: | ||||||||||||||||
| Basic | 60,246 | 51,630 | 58,291 | 51,609 | ||||||||||||
| Diluted | 61,895 | 53,268 | 58,291 | 51,609 | ||||||||||||
| Net loss per common share: | ||||||||||||||||
| Basic | $ | (0.20 | ) | $ | (0.16 | ) | $ | (0.45 | ) | $ | (0.38 | ) | ||||
| Diluted | $ | (0.20 | ) | $ | (0.18 | ) | $ | (0.45 | ) | $ | (0.38 | ) |